Surgical helmet and cover assembly, methods of making and using the same

Field of the Invention

The present invention relates generally to surgical helmets and surgical helmet components suitable for use in an operating room application, methods of producing surgical helmets and surgical helmet components, and methods of employing surgical helmets and surgical component components. surgical helmets, for example, in an operating room application.

Background of the Invention

A variety of reusable and available surgical helmets are employed in operating theaters. Helmets are employed to protect and / or protect a surgeon or other operating room staff such as during a surgical procedure. During surgical procedures, a helmet is important to provide a dividing line between the surgeon (or other operating room staff) and the patient to protect the surgeon (or other operating room staff) from exposure. to body fluids and any other contaminants. Therefore, there is a tendency for helmets and helmet components to be formed of barrier materials without further consideration such as preparation of carbon dioxide in the helmet during a surgical procedure.

Recent studies have shown that the preparation of carbon dioxide in surgical helmets is a continuing problem in surgical helmets currently available. Carbon dioxide preparation results from poor airflow through a surgical helmet produced due to one or more factors including, but not limited to, poor airflow due to the use of a fan which does not produce sufficient airflow. through the helmet, bad airflow due to uncontrolled airflow through the helmet (eg, conflicting airflow directions), and bad helmet design due to the absence of air vents in the surgical helmet. The combination of carbon dioxide preparation and stress due to the total weight of the surgical helmets currently available remain important factors in the design of new surgical helmets and helmet components. Efforts continue in the design of surgical helmets and helmet components to further enhance properties (eg barrier properties as well as air flow properties) and characteristics (eg comfort and total weight). of surgical helmets and

Petition 870190004046, of 14/01/2019, p. 12/46 helmet components.

There is a need in the art for surgical helmets and helmet components which (i) are suitable for use in an operating room application, (ii) provide superior dividing line protection to a surgeon (or other staff in the operating room staff). operations) during a surgical procedure, (iii) provides a desired extent of airflow and directional airflow controlled through the surgical helmet or helmet component to minimize the potential for carbon dioxide preparation in the helmet; (iv) are designed to be easily (v) are designed without a separate battery and wires to connect the separate battery to the helmet fan, (vi) are relatively lightweight to reduce stress on wearers, or (vii) any combination of items from (i) to (vi).

Summary of the Invention

The present invention is directed to helmets and helmet components suitable for use in an operating room application, an emergency room application, a hospital application, or a laboratory. The helmets and helmet components of the present invention provide one or more of the following characteristics: (i) upper divider line protection for a surgeon (or other operating room staff) during a surgical procedure, (ii) a desired extent of airflow and directional airflow controlled through the helmet to minimize the potential for carbon dioxide preparation in the helmet, (iii) a desired minimum helmet weight, and (iv) an optional integrated battery pack positioned on the helmet.

According to an exemplary embodiment of the present invention, a surgical helmet component is described, wherein the helmet component comprises a surgical helmet liner assembly comprising a cap sized to extend over a surgical helmet, the cap comprising a first cap material having (i) a visor aperture completely surrounded by the first cap material, (ii) at least one cap air inlet completely surrounded by the first cap material, (iii) at least one cap air inlet completely surrounded by the first cap material, and (iv) an open cap completely surrounded by the first cap material cap material, the opening of the cap being sized so that the cap can be positioned over and in a surgical helmet; a transparent visor positioned over the visor opening and attached to the first cap material near an outer periphery of the visor opening to form a sterile barrier near the outer periphery between an inner volume of the cap and an outer surface of the cap; and multiple pieces of additional cap material positioned over at least one cap air inlet and at least one cap air outlet, wherein the multiple

Petition 870190004046, of 14/01/2019, p. 13/46 pieces of additional cap material (i) are attached to the first cap material at an outer periphery of each of at least one cap air inlet and at least one cap air outlet, and (ii ) have a higher airflow permeability than the first cap material. The surgical helmet cover assembly is typically available, and may be employed with the available reusable surgical helmets.

According to another embodiment of the present invention, a surgical helmet is described, wherein the helmet comprises a structure operably adapted to surround at least a portion of the subject's head; a transparent visor attached to the frame and positioned near a front side of the helmet; an air duct having at least one air duct inlet and at least one air duct outlet, the at least one air duct outlet being positioned to supply air to a space trapped by an inner surface of the transparent visor. ; a fluid communication fan with the air channel, the fan being operatively adapted to move air through the air channel; a cap comprising a first cap material having (i) a visor aperture completely surrounded by the first cap material and sized so that an outer periphery of the visor aperture surrounds the transparent visor, (ii) at least one air inlet the cap completely surrounded by the first cap material and positioned to align with at least one air inlet, (iii) at least one vent of the cap completely surrounded by the first cap material and positioned on a rear part of the cap opposite the transparent visor, and (iv) an opening cap completely surrounded by the first cap material, the opening of the cap. dimensioned cap so that the cap can be positioned over and on the structure, the air duct and the fan; and multiple pieces of additional cap material positioned over at least one cap air inlet and at least one cap air outlet, wherein multiple pieces of additional cap material (i) are connected to the first cap material adjacent an outer periphery of each of the at least one cap air inlet and at least one cap air outlet, and (ii) have a higher air flow permeability than the first cap material.

In still another embodiment of the present invention, a surgical helmet is described, wherein the helmet comprises a structure operably adapted to surround at least a portion of the subject's head; a foam member having an air channel therein, wherein the air channel has at least one air channel inlet and at least one air channel outlet, the at least one air channel outlet being positioned to supply air to a space trapped by (i) the wearer's face and (ii) an inner surface of a transparent visor when present; and a fan supported by the foam member to be in fluid communication with the air channel, the fan being operatively adapted to move air through the air channel.

Petition 870190004046, of 14/01/2019, p. 14/46

In this embodiment, the surgical helmet may additionally comprise a permanently attached or detachable surgical helmet cover assembly, wherein the surgical helmet cover assembly comprises a transparent visor attached to the frame and positioned adjacent a front side of the helmet ; a cap comprising a first cap material having (i) a visor aperture completely surrounded by the first cap material and sized so that an outer periphery of the visor aperture surrounds the transparent visor, (ii) at least one air inlet the cap completely surrounded by the first cap material and positioned to align with at least one air inlet, (iii) at least one vent of the cap completely surrounded by the first cap material and positioned on a rear part of the cap opposite the transparent visor, and (iv) an opening cap completely surrounded by the first cap material, the opening of the cap. dimensioned cap so that the cap can be positioned over and on the structure, the air duct and the fan; and multiple pieces of additional cap material positioned over at least one cap air inlet and at least one cap air outlet, wherein multiple pieces of additional cap material (i) are connected to the first material of the cap. cap near an outer periphery of each of the at least one cap air inlet and at least one cap air outlet, and has (ii) a higher air flow permeability than the first cap material.

When the surgical helmet air channel is in a foam air channel-containing member, the foam member may comprise an upper foam member and a lower foam member attached to each other. In one embodiment, the lower and upper foam members comprise bonding features that allow the lower and upper foam members to be bonded together without the use of additional fastening material (i.e. the lower and lower foam members). superiors split together). Likewise, the lower foam member may be operatively adapted to surround at least a portion of the subject's head. In addition, the frame may be attached to the lower foam member along with other helmet components employing adhesives or mechanical closures.

In still another embodiment of the present invention, a surgical helmet is described, wherein the helmet comprises a structure operably adapted to surround at least a portion of the subject's head; a transparent visor attached to the frame and positioned near a front side of the helmet; a foam member having an air channel therein, wherein the air channel has at least one air channel inlet and at least one air channel outlet, the at least one air channel outlet being positioned in order to to provide air to a space trapped by an inner surface of the transparent visor; a vertical fan in fluid communication

Petition 870190004046, of 14/01/2019, p. With the air duct, the vertical fan being operatively adapted to move air through the air duct; a battery attached to the frame and positioned above a lower edge of the transparent visor, the battery being operatively adapted to provide electrical power to the vertical fan; and a cap surrounding the transparent visor extends above and below the structure.

In accordance with yet another exemplary embodiment of the present invention, the surgical helmet comprises a structure operably adapted to surround at least a portion of the subject's head; a transparent visor attached to the frame and positioned near a front side of the helmet; an air channel having a single air channel inlet and a single air channel outlet, the only air channel outlet being positioned to supply air to a space trapped by an inner surface of the transparent visor; a vertical fan in fluid communication with the air channel and positioned at a distance from both the single air channel inlet and the only air channel outlet, the fan being operatively adapted to move air through the air channel. air; a cap surrounding the transparent visor extends above and below the structure; a single cap air inlet located at a periphery of the cap and aligned with the single air channel inlet of the air channel; and at least one cap air outlet located at a periphery of the cap, wherein the only cap air inlet and at least one cap air outlet are operatively adapted to provide air flow through the helmet to decrease the amount of carbon dioxide preparation in the helmet.

The present invention is also directed to surgical equipment comprising at least one surgical helmet. In one embodiment, the surgical equipment comprises a surgical helmet, and a surgical robe sized to extend from a region of a user's neck to a region of the waist or below where the helmet cap is sized to to extend below the neck region of the wearer, and when a lower part of the cap is folded into an upper part of the dressing gown, at least one air outlet from the cap, when present, It is positioned above the surgical robe. In this embodiment, the helmet may comprise one or more of the following components: (1) a structure operably adapted to surround at least a portion of the subject's head; (2) an air channel (e.g., a foam member having an air channel therein) having at least one air channel inlet and at least one air channel outlet, at least one air channel outlet being positioned to provide air to a space trapped by (i) the wearer's face and (ii) an inner surface of a transparent visor when present; (3) a fluid communication fan with the air channel, the fan being operatively adapted to move air through the air channel; and (4) a set of

Petition 870190004046, of 14/01/2019, p. A permanently attached or detachable surgical helmet cover, wherein the surgical helmet cover assembly comprises (4a) a transparent visor attached to the frame and positioned adjacent a front side of the helmet; (4b) a cap comprising a first cap material having (i) a visor aperture completely surrounded by the first cap material and dimensioned so that an outer periphery of the visor aperture surrounds the transparent visor, (ii) at least one cap air inlet completely surrounded by the first cap material and positioned to align with at least one air inlet, (iii) at least one vent of the cap completely surrounded by the first cap material and positioned on a rear part of the cap opposite the transparent visor, and (iv) an opening cap completely surrounded by the first cap material, the opening of the cap. dimensioned cap so that the cap can be positioned over and on the structure, the air duct and the fan; and (4c) the multiple pieces of additional cap material positioned over at least one cap air inlet and at least one cap air outlet, wherein the multiple pieces of additional cap material (i) are connected to the first cap material near an outer periphery of each of the at least one cap air inlet and at least one cap air outlet, and (ii) have a higher air flow permeability than the first cap material cap.

The present invention is likewise directed to methods of producing surgical helmets and components of surgical helmets. In one embodiment, the method of producing a surgical helmet component comprises producing a surgical helmet cover assembly, wherein the method comprises providing a cap comprising (1) a first cap material having (i) an aperture of the cap. visor near one front side of the cap and completely surrounded by the first material of the cap, (ii) at least one cap air inlet near an upper cap and completely surrounded by the first cap material; (iii) at least one cap air outlet at one rear side by the cap opposite the visor opening and completely surrounded by the first cap material, (iv) an opening cap completely surrounded by the first cap material, an opening of the cap sized so that the cap can be positioned over a surgical helmet; (2) a transparent visor positioned at the visor opening and attached to the first cap material near an outer periphery of the visor opening; and (3) multiple pieces of additional cap material positioned over at least one cap air inlet and at least one cap air outlet, wherein multiple pieces of additional cap material (i) are connected to the first cap material near an outer periphery of each of the at least one cap air inlet and at least one cap air outlet, and (ii) have a higher air flow permeability than the first cap material . O

Petition 870190004046, of 14/01/2019, p. An exemplary method may further comprise a number of additional steps such as connecting the transparent visor to the first cap material; connecting the multiple pieces of additional cap material to the first cap material; and attaching one or more attachment members to the first cap material and / or the transparent visor. The resulting surgical helmet cover assembly may be detachably or permanently attached to a helmet frame.

In another embodiment, the present invention is directed to a method of producing a surgical helmet, wherein the method comprises providing a helmet structure, the structure being operatively adapted to surround at least a portion of the subject's head; providing a foam member having an air channel therein, the foam member having at least one air channel inlet and at least one air channel outlet, the at least one air channel outlet being positioned to provide air to a space trapped by (i) the wearer's face and (ii) an inner surface of a transparent visor when present, the foam member being bonded to or integrally formed in the structure; and providing a fluid communication fan with the air channel, the fan being operatively adapted to move air through the air channel.

The present invention is furthermore directed to methods of using a surgical helmet or helmet component in an operating room application. In an exemplary embodiment of the present invention, the method comprises providing a helmet or helmet component such as one of the helmet components or helmets described above; and interrupting the fan to provide a trajectory air flow in at least one cap air inlet to at least one air channel inlet through the air channel through at least one inlet air outlet. a region of the helmet secured by the transparent visor, and through the helmet by means of at least one air vent of the cap. The helmets or surgical helmets components described above provide directional airflow controlled through a prone surgical helmet to minimize carbon dioxide preparation in the surgical helmet.

The present invention is furthermore directed to methods of reducing an amount of carbon dioxide in a surgical equipment during use. In one embodiment of the embodiment, the method comprises providing surgical equipment of the present invention (such as the surgical equipment described above or any surgical equipment described below), and interrupting the blower to provide an air flow path by at least one air intake from the cap on a helmet to at least one air inlet through an air duct, through at least one air outlet in a region of the helmet secured by a visor

Petition 870190004046, of 14/01/2019, p. 18/46 and through the helmet by means of at least one air vent of the cap. The surgical equipment of the present invention is capable of reducing the amount of carbon dioxide in the surgical equipment during use to below about 2500 ppm, and even below about 1800 ppm.

These and other features and advantages of the present invention will become apparent upon a review of the following detailed description of the disclosed embodiments and the appended claims.

Brief Description of the Figures

The present invention is likewise described with reference to the accompanying figures, wherein:

Figure 1 is a side view of an exemplary surgical helmet cover assembly of the present invention;

Figure 2A is a front view of the exemplary surgical helmet cover assembly shown in Figure 1;

Figure 2B is a rear view of the exemplary surgical helmet cover assembly shown in Figure 1;

Figure 3 is a cross-sectional view of the exemplary surgical helmet cover assembly of Figure 1 as perpendicularly observed to level AA shown in Figure 1;

Figure 4 is a side view of an exemplary surgical helmet of the present invention;

Figure 4A is a top view of the surgical helmet specimen shown in Figure 4 as seen from above the surgical helmet specimen;

Figure 4B is a cross-sectional view of the surgical helmet specimen 25 shown in Figure 4 as perpendicularly observed to level BB shown in Figure 4B.

Figure 4;

Figure 4C is an approximate view of the surgical helmet specimen shown in Figure 4 as viewed from below the helmet;

Figure 4D is a cross-sectional view of the exemplary surgical helmet 30 shown in Figure 4 as seen in plan BB shown in Figure 4;

Figure 5 is a side view of an exemplary helmet of the present invention;

Figure 6 is a rear view of the helmet copy of Figure 5;

Figure 7 is an approximate rear view of the helmet model of the

Figure 5;

Figure 8 is a view of the helmet copy of Figure 5 as shown in Figure

Petition 870190004046, of 14/01/2019, p. 19/46 observed from below the helmet;

Figure 9 is an approximate view of the helmet specimen structure, air channel, battery, and fan of Figure 5 as seen from below the helmet;

Figure 10A is a side view of the helmet copy of Figure 55 as the cap is removed;

Figure 10B is a side view of another exemplary helmet shown without a cap component; and

Figure 11 is a specimen of surgical equipment comprising the helmet specimen of Figure 5 in combination with a surgical dressing gown.

Detailed Description of the Invention

The present invention is directed to surgical helmets and surgical helmet components suitable for use in any environment in which a surgical helmet is typically employed including, but not limited to, an operating room application, an emergency room application, an application. in the hospital, a laboratory, a clean room, etc. The present invention is likewise directed to methods of producing surgical helmets and components of surgical helmets and methods of using surgical helmets and components of surgical helmets in an operating room application or any of the above mentioned environments. Surgical helmets and surgical helmet components of the present invention are particularly useful in providing the dividing line between a surgeon and a surgical site of a patient.

I. Surgical Helmets and Surgical Helmet Components

In an exemplary embodiment of the present invention, the present invention is directed to a surgical helmet cover assembly comprising a cap sized to extend over a surgical helmet, the cap comprising a first cap material having (i) an aperture of visor completely surrounded by the first cap material, (ii) at least one cap air inlet completely surrounded by the first cap material, (iii) at least one vent of the cap completely surrounded by the first cap material, and (iv) an opening cap completely surrounded by the first cap material, the cap opening being sized so that the cap can be positioned over and in a surgical helmet; a transparent visor positioned over the visor opening and attached to the first cap material near an outer periphery of the visor opening to form a sterile dividing line near the outer periphery between an inner volume of the cap and an outer surface of the cap; and multiple pieces of additional cap material positioned over at least one cap air inlet and at least one cap air outlet, wherein multiple pieces of additional cap material (i) are connected to the

Petition 870190004046, of 14/01/2019, p. First cap material adjacent an outer periphery of each of the at least one cap air inlet and at least one cap air outlet, and (ii) have a higher air flow permeability than the first one. first material of the cap. An exemplary surgical helmet cover assembly is shown in Figure 1. As shown in Figure 1, the surgical helmet casing mounting example 100 comprises the cap 101 sized to extend over a surgical helmet (not shown), wherein the cap 101 comprises the first cap material 102 having (i) a visor opening 103 completely surrounded by the first cap material 102, (ii) at least one cap air inlet 104 completely surrounded by the first cap material 102, (iii) at least one air outlet 105 of the cap completely surrounded by the first cap material 102, and (iv) a cap opening 136 completely surrounded by the first cap material 102. The opening 136 of the cap is sized so that the opening 136 of the cap can be positioned over and on a surgical helmet (not shown). The surgical helmet casing assembly 100 further comprises a transparent face shield 106 positioned over the visor opening 103 and connected to the first cap material 102 adjacent an outer periphery 107 of the visor opening 103 to form a line. sterile partition near the outer periphery 107 between an inner volume (e.g., inner volume 108 shown in Figure 3) of the cap 101 and an outer surface 109 of the cap 101. The exemplary mounting of the surgical helmet liner 100 additionally comprises multiple pieces of cap material 110 and 111 positioned over at least one cap air inlet 104 and the minus one cap air outlet 105 respectively, wherein each of the multiple pieces of cap material 110 and 111 (i) are connected to the first cap material 102 along an outer periphery 112 and 113 of each of the at least one cap air inlet 104 and at least at least one air outlet 105 of the cap respectively, and (ii) has a higher air flow permeability than the first material 102 of the cap.

As shown in Figure 1, the cap 101 of the surgical helmet casing assembly 100 may additionally comprise an opening

124 on the switch button on the releasable fan completely surrounded by the first material 102 of the cap. When present, the aperture 124 on the releasable fan switch button (i) is sized so that a surgical helmet fan switch button (see, for example, surgical switch exemplary 10 fan switch button 10 shown in Figure 10B) may fit therein, and (ii) is positioned adjacent an outer surface 140 of the cap 101, desirably above a lower edge 125 of the transparent face shield 106, and more desirably; near an outer surface of the cap 101 above the transparent face shield 106.

Petition 870190004046, of 14/01/2019, p. 21/46

Figure 2A is a front view of the surgical helmet liner mounting example 100 shown in Figure 1. As shown in Figure 2A, the transparent face shield 106 is positioned along a front side 114 of the cap 101 over opening 103 of the visor. Likewise, the transparent face shield 106 is completely surrounded by the first cap material 102. As shown in Figure 2A, the cap 101 may additionally comprise a releasable structure adjusting knob opening 121 completely surrounded by the first material 102 of the cap, wherein the relacrable structure adjusting knob opening (i) is sized in order to whereas a surgical helmet frame adjustment knob (see, for example, the surgical helmet specimen frame adjustment knob 10 shown in Figure 9) may fit thereon, and (ii) is positioned along a front side 114 of the cap 101 and above the transparent face shield 106. When the surgical helmet casing assembly 100 is employed in combination with a reusable surgical helmet, the cap 101 of the surgical casing casing assembly 100 has not comprised the releasable structure adjusting knob opening 121 producing that surgical helmet Frame adjustments are typically made on the helmet prior to the attachment of the surgical helmet casing assembly 100 to the surgical helmet.

The cap 101 of the surgical helmet casing assembly 100 typically comprises a single cap air inlet 104 positioned adjacent an upper rear portion 115 of the cap 101, and one or more cap air outlets 105 positioned adjacent one side. 116 rear of the cap 101 below the only air inlet 104 of the cap and shield 106 of opposite transparent face (for example, in a region of the wearer's neck). In a desired embodiment, the cap 101 comprises two separate cap air outlets 105 positioned side by side along a rear side 115 of the cap 101 below the single cap air inlet 104 and opposite transparent face shield (i.e. instead of a single cap air outlet 105 as shown in Figure 2B, two cap air outlets 105 are present in a neck region of the wearer neck similar to the cap 62 outlet shown in Figure 7).

As shown in Figure 2B, the cap 101 may additionally comprise a pocket 117 positioned adjacent a rear side 116 of the cap 101, wherein the pocket 117 is sized to accept a battery (not shown) therein. When present, pocket 117 may be positioned along any portion of an outer surface 140 of the cap 101, although pocket 117 is desirably positioned below at least one air inlet 104 of the cap and below at least one outlet. 105 of the cap as shown in Figure 2B. Although not shown in Figure 2B, the cap 101 may additionally comprise a slot in the first cap material 102, wherein the slot

Petition 870190004046, of 14/01/2019, p. 22/46 is desirably positioned in pocket 117 and sized so that a battery connector (not shown) can extend through the slot. In some embodiments, pocket 117 may be employed for storing a supplemental battery, with a primary battery being positioned in a component of the airway-containing structure or member (e.g., foam member) of a surgical helmet as described in the same manner. below.

Figure 3 is a cross-sectional view of the surgical helmet casing assembly 100 of Figure 1 as perpendicularly observed to level AA shown in Figure 1. As shown in Figure 3, the surgical helmet casing assembly 100 may additionally comprise one or more connecting members 118 positioned adjacent to (i) an inner surface 119 of the cap 101, (ii) an inner surface 120 of the transparent face shield 106, or (iii) both (i) and (ii). One or more connecting members 118 are operatively adapted to connect the surgical helmet casing assembly 100 to a surgical helmet (e.g., the surgical helmet 200 shown in Figure 4). Binding members 118 may comprise a variety of materials including, but not limited to, hook and / or loop material, magnets, tape, and the like.

As shown in Figure 3, the surgical helmet casing mounting assembly 100 may additionally comprise one or more adjustable visor spacers 127 positioned adjacent an inner surface 120 of the transparent face shield 106. When present, one or more adjustable visor spacers 127 are operatively adapted to alter an extended curvature line from one side of the transparent face shield 106 (i.e. side 128 shown in Figure 2A) to an opposite side of the shield 106 transparent face (ie side 129 shown in Figure 2A).

Any member (for example, a screw-type member) capable of adjusting a distance between the transparent face shield 106 and a surgical helmet component, for example, as an air channel-containing structure or member (also described below), can be employed for each adjustable visor spacer 127. Changing the curvature line of the transparent face shield 106 may help to reduce the amount of glare when viewed from a surgical site by means of transparent face shield 106.

The first cap material 102 (and pocket 117, when present) typically comprises a blood / fluid dividing line material. Blood / fluid dividing line material typically comprises a single layer of nonwoven fabric or a single layer of nonwoven fabric / laminated film having little or no air permeability. Typically, the blood / fluid dividing line material has an air permeability (i.e. as calculated using the ASTM D737 test method)

Petition 870190004046, of 14/01/2019, p. 23/46 of less than about 17.1 cm³/ min / cm² of material (0.562 ft³/ min / ft² of material). In a desired embodiment, the blood / fluid dividing line material comprises a breathable viral dividing line (BVB) fabric commercially available from Ahlstrom Corporation (Alpharetta, GA), such as a BVB polypropylene trilaminate material having a basis weight about 70 grams per square meter (gsm) and a thickness of about 0.35 millimeter (mm).

The multiple pieces of material of the additional cap 110 and 111 (likewise referred to herein as air filtration material) may comprise a variety of air filtration (i.e. permeable air) materials. Typically, each of the multiple pieces of material of the additional cap 110 and 111 comprises a nonwoven fabric such as a spunbonded fabric, a hydroentangling fabric, a needle punching fabric, a meltblown fabric, or any combination. of these. In a desired embodiment, each of the additional multiple pieces of cap material 110 and 111 comprises a spunbonded fabric, such as a commercially available nylon spunbonded fabric under the trade name CEREX® of Cerex Advanced Fabrics, Inc. (Pensacola, FL ).

Typically, each of the multiple pieces of material of the additional cap 110 and 111 comprises a nonwoven fabric having a fabric base weight of less than 100 gsm (more typically from about 9 gsm to about 95 gsm, up to more typically from about 15 gsm to about 50 gsm) and a tissue thickness of less than about 150 microns (pm), typically from about 75 pm to about 100 pm. In comparison, the first cap material 102 typically comprises one of the above-mentioned blood / fluid dividing line materials having a basis weight of more than about 50 gsm) (more typically from about 50 gsm to about 100 gsm). even more typically from about 70 gsm to about 80 gsm) and a fabric thickness of more than about 0.25 mm, typically from about 0.35 mm to about 0.5 mm. The above described surgical helmet liner assemblies of the present invention are typically available, and may be employed with available and reusable surgical helmets of the present invention such as the surgical helmets described below. An exemplary surgical helmet of the present invention is shown in Figure 4.

As shown in Figure 4, the exemplary surgical helmet 200 of the present invention comprises a frame 201 operably adapted to surround at least a portion of the subject's head (not shown); an air channel containing member 202 (e.g., a foam member) having an air channel therein (see air channel

210 4B), wherein the air channel has at least one air channel inlet 203 and at least one air channel outlet 204, the at least one air channel outlet 204 being positioned to supply air to a space held by (i) the wearer's face (not

Petition 870190004046, of 14/01/2019, p. 24/46 shown) and (ii) an inner surface of a transparent visor (not shown) when present; and a fan (see fan 213 in Figure 4A) in fluid communication with the air channel (not shown), the fan being operatively adapted to move air through the air channel of member 202 containing the air channel.

As shown in Figure 4, the specimen of the surgical helmet 200 may additionally comprise a frame adjusting knob 205 which may be employed to adjust the dimensions of the frame 201 to better fit a user's head (not shown ). Knob 205 may be employed to adjust a length (i.e. a first dimension extends from front side 206 to side

207 rear) and a width of the frame 201 (i.e., one dimension extends perpendicular to the first dimension, for example across a specimen width of the surgical helmet 200). The exemplary surgical helmet 200 may further comprise a fan adjustment knob 205 which may be employed when (i) shutting down or on the fan, (ii) changing a fan speed, or (iii) both (i) and (ii).

The exemplary surgical helmet 200 may additionally comprise front pad 209 and rear cap 211 adjacent opposite ends of frame 201 to provide additional comfort to a wearer (not shown). In addition, the surgical helmet specimen 200 may additionally comprise one or more adjustable helmet spacers 227, which, the adjustable type visor spacers 127 described above, are operatively adapted to alter a line of curvature extending from one side of one. transparent visor to an opposite side of the transparent visor to help reduce the amount of glare when viewed from a surgical site through the transparent visor.

The surgical helmet specimen 200 may be employed in combination with a permanently attached or detachable surgical helmet cover assembly, such as the surgical helmet casing assembly 100 discussed above. As shown in Figure 4, the surgical helmet specimen 200 may comprise one or more connecting members 218 which assist in attaching a surgical helmet cover assembly, such as the surgical helmet casing assembly 100 discussed above, to the copy of the surgical helmet 200. For example, the coupling members 118 of the surgical helmet casing assembly 100 shown in Figure 3 and the coupling members 218 of the surgical helmet 200 may comprise, for example, hook and loop material, respectively, to assist in attaching the mounting specimen of the surgical helmet casing 100 to the specimen of the surgical helmet 200. In other embodiments, the connecting members 118 and 218 may comprise magnets, tape, or any other type of bonding material.

Petition 870190004046, of 14/01/2019, p. 25/46 connection.

Figure 4A is a top view of the surgical helmet specimen 200 shown in Figure 4 as seen from above the surgical helmet specimen 200. As shown in Figure 4A, the air channel containing member 202 has at least one air channel inlet 203 positioned adjacent an upper rear portion 214 of air channel containing member 202, and a fan 213 in fluid communication with the air channel (not shown). Fan 213 is positioned in slot 212 and is operatively adapted to move air through the air channel of air channel containing member 202 in one direction as shown by arrow A in Figure 4A. As shown in Figure 4A, the limb

202 containing air channel may additionally comprise a notch 215 sized to house a primary battery (not shown) to provide electricity to the fan 213.

Figure 4B is a cross-sectional view of the exemplary surgical helmet 200 shown in Figure 4 as perpendicularly observed to level BB shown in Figure 4 to show air channel 210. As shown in Figure 4B, air channel

210 of the air channel containing member 202 extends from at least one air channel inlet 203 positioned adjacent an upper rear portion 214 of the air channel containing member 202 to the air channel outlet 204 positioned adjacent a front portion 216 of air channel containing member 202. Slot 212, which is sized to accommodate fan 213 (not shown), desirably has a width slightly greater than a width of the air duct 210 and a height slightly greater than a height of the air duct 210. that the adjusting fan 213 needs in slot 212 and does not move through slot 212 during operation. When the air channel containing member 202 comprises a foam member as discussed below also, slot 212 of air channel containing member 202 likewise absorbs any undesirable vibration from fan 213 positioned in slot 212. If necessary, An additional piece of material (eg foam) (not shown) may be employed for fan 213 in the precise position in slot 212.

Although not shown in Figure 4B, desirably fan 213 is in a vertical position in slot 212. In other words, desirably, fan 213 is positioned in slot 212 of air channel 210 so that fan blades 213 they move in a plane that is substantially perpendicular to an air flow direction through air channel 210 (i.e., in a plane substantially perpendicular to an air flow direction as shown by arrow A).

As also discussed below, air channel containing member 202 may also comprise one or more openings 220 in air channel containing member 202. Openings 220 may be present to also reduce a total weight of air channel containing member 202. Any number of openings 220 may be present in member 202

Petition 870190004046, of 14/01/2019, p. Air channel containing member provided that the air channel containing member 202 maintains sufficient structural integrity to support the various components of the surgical helmets described.

As shown in Figure 4B, air channel containing member 202 may comprise notch 215 for housing a battery (not shown). Desirably, a battery (not shown) is positioned in notch 215 and attached to air channel and / or frame 201 containing member 202 and positioned above a lower edge of a transparent visor (not shown), wherein the battery is operatively adapted. to provide power to the fan 213. As discussed above, an additional battery pack may be positioned in a pocket (eg pocket 117) adjacent an outer surface of a cap (e.g., cap 101) employed in combination with the surgical helmet specimen 200.

Figure 4C is an approximate view of the surgical helmet specimen 200 shown in Figure 4 when viewed below the surgical helmet specimen 200.

As shown in Figure 4C, the exemplary surgical helmet 200 also comprises strips 221 extending from opposite sides of frame 201 and / or opposite sides of an inner surface (or an outer surface 257) of air channel-containing member 202. The straps 221 help support the specimen of the surgical helmet 200 on a user's head (not shown). As discussed above, frame 201 together with frame adjustment knob 205 (not shown) may be employed to adjust a total length of frame handle 231 extending between points X and Y as shown in Figure 4C. For lathe frame adjusting knob 205 (not shown), handle length adjuster 251 either (1) moves the handle parts 231 of the frame (for example, handle parts at points X and Y) to one with the other decreases a total length of the frame handle 231 or (2) moves the parts of the frame handle 231 (e.g., handle parts at points X and Y) away from one another to increase an overall length of the frame handle 231 .

In one embodiment, the air channel containing member 202 comprises a foam member. In this embodiment, the air channel containing member 202 may comprise an upper foam member 240 and a lower foam member 241 attached to each other. As shown in Figure 4C, upper foam member 240 having lower edge 224 in combination with lower foam member 241 having lower edge 222 forms air channel 210 positioned between inner surface 228 of upper foam member 240 and inner surface 229. of lower foam member 241.

As shown in Figure 4C, the lower foam member 241 is operatively adapted to surround at least a portion of the subject's head (not shown).

Petition 870190004046, of 14/01/2019, p. 27/46

As discussed above, the frame 201 (and parts thereof) may be attached to the lower foam member 241 adjacent the inner surface 223, the outer surface 257, the lower edge 222, or any combination thereof employing mechanical adhesives or fasteners. Also, as discussed above, the lower foam member 241 may comprise one or more apertures 220 in this to reduce a total weight of the lower foam member 241.

In one embodiment, the upper foam member 240 and the lower foam member 241 comprise bonding features that allow the upper foam member 240 and the lower foam member 241 to be bonded together without the use of a foam material. additional fixation. For example, upper foam member 240 and lower foam member 241 were split together in application of a bonding force. An example of such a configuration is shown in Figure 4D.

Figure 4D is a cross-sectional view of the exemplary member 202 containing the air channel as seen in plane BB and along line EE as shown in Figure 4D.

Figure 4. As shown in Figure 4D, the exemplary air channel containing member 202 comprises upper foam member 240 comprising female connecting members 244 near the lower section 248, and male connecting members 245 adjacent to the upper limb section 247 241 lower foam. The female connecting members 244 and male connecting members 245 allow the attachment of upper and lower foam members 240 and 241 respectively to be bonded together without the use of an additional fastening material (e.g., an adhesive). In other embodiments, other desirable bonding members having different configurations may be employed, as well as additional fastening materials (e.g., an adhesive) if desired.

As shown in Figure 4D, the slot 212 for fan 213 (not shown) extends through the notch section 212A of the upper foam member 240, as well as the notch section 212B of the lower foam member 241. As discussed above, desirably, the fine-tuning fan 213 in slot 212 is in an upright position to reduce fan ventilation, movement, noise, or any combination thereof. Although shown only as a lining of a portion of a cross-sectional area of ​​the air duct 210, it should be noted that the fan 213 may extend through adjusting the air duct 210 in order to cover all of the cross-sectional area of ​​the duct duct 210. 210 or any part thereof.

The exemplary air channel-containing member 202 comprising upper foam member 240 and lower foam member 241 provides a lightweight air channel formed of foam-suitable foam material. In one embodiment, the upper and lower foam members 240 and 241 each comprise a

Petition 870190004046, of 14/01/2019, p. 28/46 patterned closed cell polyurethane foam.

Another example of the surgical helmet 10 is shown in Figure 5. As shown in Figure 5, the exemplary surgical helmet 10 comprises a transparent visor 11 adjacent a front side 20 of the helmet 10, and a cap 12 surrounding an outer periphery 13 of the visor 11 transparent and extending over and below a helmet frame 10 (e.g., frame 30 shown in Figure 10 below). The exemplary surgical helmet 10 also comprises the knob 14 which may be employed to adjust the dimensions of the frame to better fit a user's head. Knob 14 may be employed to adjust a length (i.e. a first dimension extending from the front side 20 to the rear side 21) and a width of the frame (i.e. an extended dimension perpendicular to the first dimension, e.g. through transparent visor 11). The exemplary surgical helmet 10 also comprises damper knob 15, which may be employed to adjust a damper positioned in the vicinity of an air vent in the helmet. (See, for example, damper 72 on

Figure 9, which is shown in a higher position, but may be rotated in a downward position away from the wall 73 of the frame member 33, in the direction as indicated by arrow D, to block airflow arriving through the air outlet. 28.)

The exemplary helmet 10 also comprises an air channel containing member comprising an air channel extending along the upper region 17 of the helmet 10 and having at least one air inlet (e.g. air inlet 22 shown in Figure 6 ) and at least one air outlet (e.g. air outlet 28 shown in Figure 8), wherein the at least one air outlet is positioned to supply air to a space 60 secured by an inner visor surface 11. transparent. A fan (e.g., fan 27 shown in Figure 8 below) is in fluid communication with the air channel, and is operatively adapted to move air through the air channel.

As shown in Figure 5, in some desired embodiments of the present invention, the cap specimen 12 of the helmet specimen 10 comprises (i) at least one cap air inlet 16 located at a periphery of the cap 12 and aligned with at least an air inlet (e.g. air inlet 22 shown in Figure 6) of the air channel, and (ii) at least one air outlet of the cap 18 located on a periphery of the cap 12. The cap air inlet 16 and cap air outlet 18 are operatively adapted to provide helmeted air flow 10 in order to decrease an amount of helmet carbon dioxide preparation 10. Desirably, the cap air inlet 16 (s) 16 and cap air outlet (s) 18 are positioned along a rear side 21 of the helmet 10 opposite the transparent visor 11 (see, for example, Figure 6); however, it should be understood that the air inlet 16 (s) of cap 16 and the outlet

Petition 870190004046, of 14/01/2019, p. 29/46 (s) 18 of the cap air may be positioned next to any location of the helmet 10 as the cap air inlet 16 (s) and cap air outlet (s) 18 provide air flow through 10 to reduce the amount of the helmet carbon dioxide preparation 10.

Figure 6 provides a rear view of the helmet specimen 10. As shown in Figure 6, the cap specimen 12 of the helmet specimen 10 comprises (i) a single cap air inlet 16 located on a periphery of the cap 12, and (ii) two substantially similar cap air vents 18 and 19 located on a periphery of the cap 12 below the cap air inlet 16 and positioned side by side along a region of the cap neck 12. As shown in Figure 6, the cap air inlet 16 is located on a periphery of the cap and is aligned with the air inlet 22 of the air channel 25. Cap air outlets 18 and 19 are located on a cap periphery , and positioned below the air inlet 16 of the cap. In this embodiment, air enters helmet 10 at a position above the wearer's head, and exits helmet 10 near a region of the wearer's neck as indicated by the dashed line LL. The exemplar of cap 12 extends below the dashed line LL to the lower edge 24 of cap 12.

In this embodiment copy of Figure 6, the helmet copy 10 comprises a power switch 23 positioned next to the upper region 17 of the helmet 10. The power switch 23 is operably adapted to the switch from an off position to an on-off position. to power the fan (for example, fan 27 shown in Figure 8 below) and turn off the power to the fan. In another exemplary embodiment, the power switch 23 is provided at other locations such as a position near an upper periphery of the transparent visor 11 (see, for example, the power switch 23 shown in Figure 10).

Figure 7 provides an approximate rear view of helmet copy 10. As shown in Figure 7, a first air filtration material 61 forms the air inlet 16 of the cap specimen 12, and a second air filtration material 62. air forms the air outlets 18 and 19 of the cap of the copy of cap 12. The first air filter material 61 and the second air filter material 62 may comprise a variety of filter materials such as the materials described above for the multiple pieces of material 110 and 111 of the additional cap. In a desired embodiment, each first and second air filtration material 61 and 62 comprises a spunbonded fabric, such as a commercially available nylon spunbonded fabric under the trade name CEREX® of Cerex Advanced Fabrics, Inc. (Pensacola, FL).

The remaining portions of cap 12 (i.e. all of cap 12 other than cap air inlet 16 and cap air outlets 18 and 19) typically comprise a

Petition 870190004046, of 14/01/2019, p. Blood / fluid dividing line such as the blood / fluid dividing materials described above for the first cap material 102. In a desired embodiment, cap 12 comprises any commercially available breathable viral partition line (BVB) fabrication from Ahlstrom Corporation (Alpharetta, GA), such as a BVB polypropylene trilaminate material.

Figure 8 provides a view of the helmet 10 specimen of Figure 5 as viewed from below the helmet 10 (e.g. when viewed from position V shown in Figure 5). As shown in Figure 8, the helmet specimen 10 comprises the frame 30, which is operatively adapted to surround at least a portion of the subject's head (not shown). Frame 30 typically comprises one or more components of the frame. In the exemplary helmet 10, the frame 30 comprises the following frame components: adjustable frame member 31, which extends around at least a portion of the subject's head and may be adjusted to length and width dimensions by employing button 14 as described above; frame member 32, which at least partially surrounds the transparent visor 11 and connects the transparent visor 11 to other helmet components; frame member 33, which extends along a front side 20 of the helmet specimen 10 and connects adjustable frame member 31 to frame member 32; button extension member 37 extends along a portion of the component

33 of the structure and being rotatably connected the knob 14; and frame member 34, which extends from a first location 65 next to adjustable frame member 31 to a second location 66 next to adjustable frame member 31 and is operably adapted to fit an outer contour of the head of the individual.

As shown in Figure 8, the helmet copy 10 may additionally comprise the pads 35 positioned next to one or more of the frame components described above. As shown in Figure 8, the helmet specimen 10 comprises multiple pads 35 positioned next to the adjustable frame member 31 and a single pad 35 positioned next to the frame member 34. THE

Figure 8 provides a view of a battery pack 26 which is present in some helmets of the present invention. As shown in Figure 8, the exemplary battery pack 26 is positioned opposite opposite sides of the air duct 25. The electrical connection (not shown) connects the battery pack 26 to the fan 27 and the power switch 23 (shown in Figures 6 and 10). Although shown on opposite sides of the air duct 25, it should be understood that the battery pack 26 may be located adjacent any portion of the frame 30. Desirably, as shown in Figures 8-10, the battery pack 26 is located above a lower edge of the

Petition 870190004046, of 14/01/2019, p. Transparent visor more desirably above an upper portion of the transparent visor and at one or both sides of the air duct 25.

Figure 9 provides an approximate view of the various components of the helmets on the helmet specimen 10. As shown in Figure 9, the helmet specimen 10 comprises the air duct 25 extending between the air inlet 22 and the air outlet 28. battery pack 26 is positioned adjacent opposite sides of air channel 25. Electrical connection 39 connects battery pack 26 to fan 27 and power switch 23 (shown in Figures 6 and 10). As shown in Figure 9, fan 27 is positioned in air duct 25 in the vicinity of air outlet 28. However, it should be understood that fan 27 may be positioned anywhere in air duct 25 or inlet 22. Damper 72 is positioned adjacent wall 73 of frame member 33 in a high position, but may be rotated downwardly away from wall 73 and over air outlet 28 to block and / or redirect air flow by helmet middle 10. The degree of airflow direction and air lock can be controlled by turning knob 15 as discussed above.

Figure 10A provides a side view of the helmet specimen 10 of Figure 5 as the cap 12 is removed. As shown in Figure 10A, helmet exemplar 10 comprises component 31 of the adjustable frame sized to extend around at least a portion of the subject's head; knobs 14 and 15, which are operatively adapted to adjust the dimensions of the adjustable frame member 31 and the air flow through the helmet respectively; the frame member 32 partially surrounding the transparent visor 11; the frame member 34, which is operatively adapted to suit an external contour of the subject's head; battery pack 26; the fan 27; the air channel 25; air inlet 22; the air outlet 28; electrical connection 40 connecting battery pack 26 to fan 27; and the power switch 23.

Figure 10B provides a side view of another exemplary helmet 10 without a cap component. As shown in Figure 10B, helmet exemplar 100 comprises patterned helmet member 78; knob 14, which is operatively adapted to adjust the dimensions of a frame member (not shown, but similar to the adjustable frame member 31 shown in Figure 10A) extending around at least a portion of the subject's head; the frame member 32 partially surrounding the transparent visor 11; the frame member 34, which is operatively adapted to suit an external contour of the subject's head; battery pack 26; the fan 27; the air channel 25; air inlet 22; the air outlet 28; the electrical connection by connecting the battery pack 26 to the fan 27 (not shown, but typically on or near an internal surface of the component 78 of

Petition 870190004046, of 14/01/2019, p. 32/46 helmet); and the power switch / button 23, which is operatively adapted to provide electricity to the fan and to adjust the fan speed (i.e. airflow through the helmet).

As shown in Figure 6B, the fan 27 may be positioned near the air inlet 22 of the air channel 25. Also, the battery pack 26 may be positioned adjacent a rear outer surface of the helmet member 78. Although power switch / button 23 is shown as a single switch / button on helmet copy 100 it should be understood that the power switch and a separate airspeed control knob may be present on the helmet copy

100 As discussed above, multiple air inlets 22 and / or air outlets 28 may be used in the helmet copy 100 to provide air flow through the helmet copy 100. Also, one or more air inlets 22 and / or air vents 28 may be positioned on the helmet copy 100 at any desired location to provide air flow through the helmet copy 100.

In one embodiment, any of the helmets described above are sterilized prior to use. For example, in an operating room application, a sterile field should be kept around a surgical procedure site. Therefore, a surgical helmet employed during such a surgical procedure must be sterilized prior to use.

Typically, the helmets of the present invention are available. However, in some cases, the helmets of the present invention may be reusable. When reused, the helmet may need to undergo a cleaning procedure and / or sterilization procedure prior to reuse.

The present invention is also directed to surgical equipment comprising at least one helmet. A specimen of surgical equipment is shown in Figure 7. As shown in Figure 7, specimen of surgical equipment 70 comprises the specimen of the surgical helmet 10 (or the specimen of the surgical helmet 200 in combination with the specimen of the helmet casing 100 in combination with the surgical robe 50. The surgical robe 50 is sized to extend from a region of a user's neck to a region of or below the user's waist. The cap 12 of the surgical helmet 10 (or the cap 101 of the surgical helmet casing assembly 100) is sized to extend below the neck region of the wearer. In a desired configuration shown in Figure 7, a lower portion 120 of cap 12 (summarized by dashed line MM) is folded into one portion.

52 Desirably, when at least one air outlet 18 is present in the cap 12 (or cap 101 of the surgical helmet liner mounting example 100), the at least one air outlet 18 is positioned above the edge. 51

Petition 870190004046, of 14/01/2019, p. Upper portion of the surgical robe 50. In such a configuration, upper portion 52 of the surgical robe 50 effectively blocks airflow in the surgical robe 50 and exits through at least one air outlet 18.

It should be noted that the surgical helmets 10 and 200 as shown in Figure 1-7 are only two of the exemplary surgical helmets of the present invention. Various modifications may be prepared for the specimen of surgical helmets 10 and 200 including, but not limited to, increasing the number of cap air inlet (s) 16 (or cap air inlet (s) 104) and / or number of cap air vents 18 and 19 (or cap air outlet (s) 105); increase or decrease the size of one or more components (eg transparent visor 11 and / or cap air inlet 16 (s) and / or cap air outlets 18 and 19) relative to other components (eg cap 12); and recombining one or more components of the exemplary helmets 10 and 200 (for example, by changing the position of the fan 27 closer to the air inlet 22 and / or by changing the position of the air vents 18 and 19 of the closer to the clear visor 11 and / or also away from the cap air inlet 16 (s)).

Typically, the surgical helmets of the present invention comprise from one to about five cap air inlets 16 (or cap air inlets (104)), from one to about five cap air outlets 18 and 19 (or air outlet (s) 105 of the cap), a single fan 27 (or fan 213), and a single air channel 25 (or air channel 210);

however, the surgical helmets of the present invention could comprise, for example, multiple fans and / or multiple air passages.

II. Surgical Helmet Production Methods and Surgical Helmet Components

The present invention is also directed to methods of producing surgical helmets and components of surgical helmets such as components of surgical helmets and surgical helmets described above. In one exemplary embodiment, the present invention is directed to a method of producing a surgical helmet component comprising a surgical helmet cover assembly, wherein the method comprises providing a cap comprising (1) a first cap material having ( (i) a visor opening near a front side of the cap and completely surrounded by the first cap material; (ii) at least one cap air inlet near an upper cap and completely surrounded by the first cap material; (iii) at least one cap air outlet at one rear side of the cap opposite the visor opening and completely surrounded by the first cap material, (iv) an opening cap completely surrounded by the first cap material, the opening of the cap is sized so that the cap can be positioned over a surgical helmet; (2) a transparent visor positioned at the visor opening and attached to the

Petition 870190004046, of 14/01/2019, p. First material of the cap near an outer periphery of the visor opening; and (3) multiple pieces of additional cap material positioned over at least one cap air inlet and at least one cap air outlet, wherein multiple pieces of additional cap material (i) are connected to the first cap material near an outer periphery of each at least one cap air inlet and at least one cap air outlet, and (ii) have a higher air flow permeability than the first cap material.

The exemplary method of producing a surgical helmet component may additionally comprise one or more of the following exemplary steps: attaching the transparent visor to the first cap material; connecting the multiple pieces of the additional cap material to the first cap material; attaching one or more attachment members to an inner surface of the first cap material and / or the transparent visor (e.g. attachment members 118); attaching one or more visor spacers to an inner surface of the first cap material and / or the transparent visor (e.g., spacer members 127); cut one or more openings in the first material of the cap; attaching a pocket (e.g. pocket 117) to an outer surface of the first cap material; and either temporarily or permanently connects the resulting surgical helmet component (e.g., the surgical helmet liner mounting specimen 100) to a surgical helmet (e.g., the surgical helmet specimen

200).

In another embodiment, the present invention is directed to a method of producing a surgical helmet, wherein the method comprises providing a helmet structure, the structure being operatively adapted to surround at least a portion of the subject's head; providing an air channel (e.g., a foam member having an air channel therein) having at least one air channel inlet and at least one air channel outlet, the at least one air channel outlet being positioned in order to supply air to a space trapped by (i) the wearer's face and (ii) an inner surface of a transparent visor when present, the air channel being attached to or integrally formed in the structure; and providing a fluid communication fan with the air channel, the fan being operatively adapted to move air through the air channel.

The exemplary method of producing a surgical helmet may additionally comprise a number of additional steps including, but not limited to, forming one or more shaped components for forming an air channel-containing member (e.g., member containing 202 air channel); connecting two or more components to one another (e.g., lower and upper foam members 240 and 241) to form an air channel containing member; provide helmet cover set

Petition 870190004046, of 14/01/2019, p. Described above, wherein the surgical helmet cover assembly may be detachably or permanently attached to the helmet structure; attaching the surgical helmet cover assembly described above to the surgical helmet; incorporating a battery into the helmet to be positioned above a lower edge of the transparent visor, the battery being operatively adapted to provide power to the fan; and positioning a fan (e.g., fan 213) in an air channel so that the fan is a distance from the air inlet (s) and air outlet (s) of the air channel.

In another embodiment, the method of producing a helmet comprises providing a helmet structure, the structure being operatively adapted to surround at least a portion of the subject's head; attach a transparent visor to the frame to be positioned near a front side of the helmet; providing an air channel containing member (for example, a foam air channel containing member formed of lower and upper foam members 240 and 241) having at least one air inlet and at least one air outlet the air channel being bonded to or integrally formed in the structure; providing a fluid communication fan with the air channel, desirably, in a vertical position, the fan being operatively adapted to move air through the air channel; providing a cap such as the cap described above (for example cap 101) which surrounds the transparent visor and extends over and below the frame; and optionally incorporates a battery in the helmet, the battery being operatively adapted to provide power to the fan. Desirably, the at least one air outlet is positioned to supply air to a space trapped by an inner surface of the transparent visor. In other desired embodiments, the battery, when present, is positioned above a lower edge of the transparent visor, more desirably above an upper edge of the transparent visor.

Also, an additional battery can be provided in a pocket near an outer surface (for example, a rear surface) of the cap.

In another embodiment, the helmet production method comprises providing a helmet structure, the structure being operatively adapted to surround at least a portion of the subject's head; attach a transparent visor to the frame to be positioned near a front side of the helmet; providing an air channel having at least one air inlet and at least one air outlet, the air channel being connected to or integrally formed in the structure; providing a fluid communication fan with the air channel, the fan being operatively adapted to move air through the air channel; and attaching a cap to the frame to surround the transparent visor and extending above and below the frame, the cap comprising the cap described above (e.g. the cap 101), wherein the at least one air inlet of the cap and at least one air vent from the cap (in combination with

Petition 870190004046, of 14/01/2019, p. 36/46 the fan described above, for example, the fan 213) is operatively adapted to provide air flow through the helmet in order to decrease an amount of carbon dioxide preparation in the helmet. Desirably, the at least one air outlet is positioned to supply air to a space trapped by an inner surface of the transparent visor.

Any of the individual components described above employed to form the helmets and the helmet components of the present invention may be formed by employing conventional methods. For example, helmet components including, but not limited to, adjustable frame component 31, frame component 32, frame component 33, frame component 34, frame component 201, frame extension member 37 buttons 14 and 15, to air channel containing member 25 or 202, and transparent visor 11 or 206, may be formed of any hot-melt material including, but not limited to, polymeric materials, metallic materials, or a combination thereof. Thermoformed materials may be shaped or molded using any conventional molding technique. Typically, the above-mentioned helmet components are formed from polymeric materials such as polyolefins (e.g., olefin copolymers, and polyethylene, polypropylene), polyurethanes, acrylonitrile butadiene styrene (ABS) copolymers, polyesters, polyethylene terephthalate with glycol (PETG) , polyamides, etc.

Any film or film-like components including, but not limited to, adjustable frame component 31, frame component 34 and frame component 201 may be forming by any film forming process including, but not limited to, an extrusion process. film blowing, a film blowing process, etc.

Fiber-containing helmet components, such as cap 12 or cap 101, the first and second air filtration material 61 and 62, and the additional multiple pieces of cap material 110 and 111 may be formed by employing powder forming processes. conventional fabric including, but not limited to, blow fusion processes, spunbonding processes, spunlacing processes, hydro-entangling processes, carding processes, needle perforation processes, etc. Typically, fiber-containing helmet components are formed from polymeric materials such as polyolefins (e.g., olefin copolymers, and polyethylene, polypropylene), nylon, acrylonitrile butadiene styrene (ABS) copolymers, etc.

Thermoformed parts, films and / or layers of fabric may be joined to one another by employing any conventional bonding technique including, but not limited to, thermal bonding, adhesive bonding, mechanical bonding (e.g. hook and loop material) ), etc. In a copy of the present embodiment

Petition 870190004046, of 14/01/2019, p. According to the invention, the cap is formed of an Ahlstrom Corporation BVB Material (e.g., polypropylene trilaminate material) and is thermally bonded to an outer periphery of a transparent PETG visor employing a conventional bonding mechanism (e.g. an ultrasonic welding machine).

In a desired embodiment, the surgical helmets and helmet components of the present invention are formed from the following materials: a closed cell polyurethane foam shaped helmet component (e.g., helmet component 78 and foam members 240 and 241 lower and upper); the frame components (for example, frame component 201 shown in

Figure 4 and component 31 of the adjustable structure shown in Figure 6A) formed of polyethylene; a transparent visor (e.g., transparent visor 11 or 106) formed of PETG; a frame member extended around the transparent visor, when present (e.g. frame member 32) formed of polyvinyl chloride (PVC); VELCRO® trademark absorbent cloth headband material;

batteries - 4 AAA Alkaline batteries; and air inlet and outlet material formed of CEREX® nylon spunbonded fabric.

III. Methods of Using Surgical Helmets and Components of Surgical Helmets

The present invention is also directed to methods of wearing the helmets described above in an operating room application. In one embodiment of the embodiment, the method comprises a method of providing a dividing line between a surgeon (or other operating room staff) and a patient in an operating room application, wherein the method comprises the step of positioning the helmet over at least a portion of the surgeon's head (or any other head of the operating room staff) to separate the surgeon (or other operating room staff) from a surgical procedure site. Typically, the helmet is employed in combination with a surgical robe and other protective clothing (eg, butines, gloves, etc.) to provide a dividing line between the surgeon and a surgical procedure site.

In another embodiment, the present invention is directed to a method of reducing an amount of carbon dioxide in a surgical equipment during use. In this exemplary embodiment, the method comprises (A) providing surgical equipment comprising (1) a helmet comprising (i) a structure operably adapted to surround at least a portion of the subject's head; (ii) a transparent visor attached to the frame and positioned near a front side of the helmet; (iii) an air channel having at least one air inlet and at least one air outlet, the at least one air outlet being positioned to supply air to a space

Petition 870190004046, of 14/01/2019, p. 38/46 secured by an inner surface of the transparent visor; and (iv) a fan in fluid communication with the air channel, the fan being operatively adapted to move air through the air channel; and (2) a surgical cap or dressing gown surrounding the transparent visor and extending above and below the frame, the surgical cap or dressing gown comprising (i) at least one air inlet located on a periphery of the aligned surgical cap or dressing gown with at least one air inlet of the air channel, and (ii) at least one air outlet located on a periphery of the surgical cap or dressing gown; and (B) fan interruption to provide airflow along a path through surgical equipment components in the following order: an air inlet in a surgical gown, at least one air inlet of the cap on a helmet, for at least one air inlet through an air channel through at least one air outlet in a region of the helmet secured by a transparent visor through the helmet through at least one vent of the cap, and through the surgical robe by at least one vent in the surgical robe.

Desirably, the method of reducing an amount of carbon dioxide in a surgical equipment comprises employing the surgical helmet specimen 200 described above in combination with the surgical helmet casing assembly 100 and a surgical dressing gown. As discussed above, the surgical helmet specimen 200 in combination with the surgical helmet casing assembly 100 provides controlled airflow as well as directional airflow controlled through the surgical equipment. In other words, a sufficient volume of air and essentially no return air flow direction (e.g., from the cap air inlet 104 to at least one air channel inlet 203, via air channel 210, through at least one airway outlet 204 in a region of the surgical helmet

200 secured by the transparent visor 206, along the line at the wearer's neck, and through the surgical helmet 200 by means of at least one vent 105 of the cap on a back of the surgical helmet 200) by the surgical helmet specimen 200 and the mounting specimen of the surgical helmet liner 100 allow for a significant reduction in carbon dioxide preparation in a surgical equipment.

In a desired embodiment, the method of reducing an amount of carbon dioxide in a surgical equipment during use results in a carbon dioxide level of less than about 5000 ppm, more desirably less than about 4000 ppm, more desirably less than about 3500 ppm, and even more desirably less than about 3000 ppm (or less than about 2500 ppm, or less than about 2000 ppm, or less than about 1800 ppm).

The surgical equipment of the present invention likewise improves airflow through the surgical equipment. For example, air flow through a

Petition 870190004046, of 14/01/2019, p. Surgical equipment without at least one air vent from the cap may be in the range of about 0.071 to about 0.096 cubic meters per minute (cmm) (2.5 to about 3.4 cubic feet per minute (cfm) ), while the air flow through surgical equipment of the present invention with at least one cap air outlet may be in the range of about 0.110 to about 0.156 cmm (3.9 to about 5 mm). , 5 cfm), an increase in air flow of as much as 120%.

In some embodiments, the methods described above may additionally comprise one or more of the following steps: sterilize the helmet before use, remove the helmet from packing material, adjust the helmet structure to fit the surgeon's head, check the energy supplied to ensure the fan is operational, combine the helmet with other protective clothing , fold a portion of the helmet cap into a surgical robe, and convert the energy supplied to the fan.

While the specification has been described in detail with respect to the specific embodiments thereof, it should be noted by one skilled in the art, in achieving an understanding of the background, can easily conceive changes for variations of and equivalent to these embodiments. Accordingly, the scope of the present invention should be assessed as those of the appended claims and any equivalents thereto.