SURGICAL HELMET AND COVER ASSEMBLY, METHODS OF MAKING AND USING THE SAME

This application is being filed as a PCT International Patent Application in the name of Microtek Medical, Inc., a U.S. corporation, claiming priority to U.S. Patent Application Serial No. 11/710,699 filed on 26 February 2007.

FIELD OF THE INVENTION

The present invention relates generally to surgical helmets and surgical helmet components suitable for use in an operating room setting, methods of making surgical helmets and surgical helmet components, and methods of using surgical helmets and surgical helmet components, for example, in an operating room setting.

BACKGROUND OF THE INVENTION

A variety of disposable and reusable surgical helmets are used in operating rooms. Helmets are used to protect and/or cover a surgeon or other operating room personnel such as during a surgical procedure. During surgical procedures, it is important for a helmet to provide a barrier between the surgeon (or other operating room personnel) and the patient so as to protect the surgeon (or other operating room personnel) from exposure to body fluids and any other contaminants. Consequently, there is a tendency to for helmets and helmet components to be formed from barrier materials without additional considerations such as carbon dioxide build-up within the helmet during a surgical procedure.

Recent studies have shown that carbon dioxide build-up within surgical helmets is an ongoing problem with currently available surgical helmets. Carbon dioxide build-up results from poor air flow through a given surgical helmet due to one or more factors including, but not limited to, poor air flow due to the use of a fan that does not produce sufficient air flow through the helmet, poor air flow due to uncontrolled air flow through the helmet (e.g., conflicting air flow directions), and poor helmet design due to the absence of air outlets in the surgical helmet. The combination of carbon dioxide build-up and stress due to the overall weight of currently available surgical helmets continue to be 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 the properties (e.g., barrier properties, as well as air flow properties) and characteristics (e.g., comfort and overall weight) of surgical helmets and helmet components.

There is a need in the art for surgical helmets and helmet components that (i) are suitable for use in an operating room setting, (ii) provide superior barrier protection to a surgeon (or

other operating room personnel) during a surgical procedure, (iii) provide a desired degree of air flow and controlled directional air flow through the surgical helmet or helmet component so as to minimize the potential for carbon dioxide buildup within the helmet, (iv) are designed to be easily operational, (v) are designed without a separate battery pack and wires for connect the separate battery pack to the fan of the helmet, (vi) are relatively lightweight to reduce stress on the wearer, or (vii) any combination of items (i) to (vi).

SUMMARY OF THE INVENTION

The present invention is directed to helmets and helmet components suitable for use in an operating room setting, an emergency room setting, a hospital setting, or a lab. The helmets and helmet components of the present invention provide one or more of the following features: (i) superior barrier protection to a surgeon (or other operating room personnel) during a surgical procedure, (ii) a desired degree of air flow and controlled directional air flow through the helmet so as to minimize the potential for carbon dioxide buildup within the helmet, (iii) a desired minimal helmet weight, and (iv) an optional integrated battery pack positioned within the helmet.

According to one exemplary embodiment of the present invention, a surgical helmet component is disclosed, wherein the helmet component comprises a surgical helmet cover assembly comprising a hood sized to extend over a surgical helmet, the hood comprising a first hood material having (i) a face shield aperture completely surrounded by the first hood material, (ii) at least one hood air inlet completely surrounded by the first hood material, (iii) at least one hood air outlet completely surrounded by the first hood material, and (iv) a hood opening completely surrounded by the first hood material, the hood opening being sized so that the hood can be positioned over and onto a surgical helmet; a transparent face shield positioned over the face shield aperture and bonded to the first hood material along an outer periphery of the face shield aperture so as to form a sterile barrier along the outer periphery between an interior volume of the hood and an exterior surface of the hood; and multiple pieces of additional hood material positioned over the at least one hood air inlet and the at least one hood air outlet, wherein the multiple pieces of additional hood material (i) are bonded to the first hood material along an outer periphery of each of the at least one hood air inlet and the at least one hood air outlet, and (ii) have an air flow permeability greater than the first hood material. The surgical helmet cover assembly is typically disposable, and may be used with disposable or reuseable surgical helmets.

According to a further exemplary embodiment of the present invention, a surgical helmet is disclosed, wherein the helmet comprises a frame operatively adapted to surround at least a

portion of a person's head; a transparent face shield attached to the frame and positioned along a front side of the helmet; an air channel having at least one air channel inlet and at least one air channel outlet, the at least one air channel outlet being positioned so as to provide air to a space bound by an inner surface of the transparent face shield; a fan in fluid communication with the air channel, the fan being operatively adapted to move air through the air channel; a hood comprising a first hood material having (i) a face shield aperture completely surrounded by the first hood material and sized so that an outer periphery of the face shield aperture surrounds the transparent face shield, (ii) at least one hood air inlet completely surrounded by the first hood material and positioned to align with the at least one air channel inlet, (iii) at least one hood air outlet completely surrounded by the first hood material and positioned on a rear portion of the hood opposite the transparent face shield, and (iv) a hood opening completely surrounded by the first hood material, the hood opening sized so that the hood can be positioned over and onto the frame, the air channel and the fan; and multiple pieces of additional hood material positioned over the at least one hood air inlet and the at least one hood air outlet, wherein the multiple pieces of additional hood material (i) are bonded to the first hood material along an outer periphery of each of the at least one hood air inlet and the at least one hood air outlet, and (ii) have an air flow permeability greater than the first hood material.

According to yet a further exemplary embodiment of the present invention, a surgical helmet is disclosed, wherein the helmet comprises a frame operatively adapted to surround at least a portion of a person'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 so as to provide air to a space bound by (i) the face of a wearer and (ii) an inner surface of a transparent face shield when present; and a fan supported by the foam member so as to be in fluid communication with the air channel, the fan being operatively adapted to move air through the air channel. In this exemplary embodiment, the surgical helmet may further comprise a detachable or permanently attached surgical helmet cover assembly, wherein the surgical helmet cover assembly comprises a transparent face shield attached to the frame and positioned along a front side of the helmet; a hood comprising a first hood material having (i) a face shield aperture completely surrounded by the first hood material and sized so that an outer periphery of the face shield aperture surrounds the transparent face shield, (ii) at least one hood air inlet completely surrounded by the first hood material and positioned to align with the at least one air channel inlet, (iii) at least one hood air outlet completely surrounded by the first hood material and positioned on a rear portion of the hood opposite the transparent face shield, and (iv) a hood opening completely surrounded by the first hood material, the hood

opening sized so that the hood can be positioned over and onto the frame, the air channel and the fan; and multiple pieces of additional hood material positioned over the at least one hood air inlet and the at least one hood air outlet, wherein the multiple pieces of additional hood material (i) are bonded to the first hood material along an outer periphery of each of the at least one hood air inlet and the at least one hood air outlet, and (ii) have an air flow permeability greater than the first hood material.

When the air channel of the surgical helmet is within a foam air channel containing member, the foam member may comprise an upper foam member and a lower foam member attached to one another. In one exemplary embodiment, the upper and lower foam members comprise attachment features that enable the upper and lower foam members to be attached to one another without the use of an additional fastening material (i.e., the upper and lower foam members snap together). Further, the lower foam member may be operatively adapted to surround at least a portion of a person's head. In addition, the frame may be attached to the lower foam member along with other helmet components using mechanical fasteners or adhesives.

According to yet a further exemplary embodiment of the present invention, a surgical helmet is disclosed, wherein the helmet comprises a frame operatively adapted to surround at least a portion of a person's head; a transparent face shield attached to the frame and positioned along 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 so as to provide air to a space bound by an inner surface of the transparent face shield; an upright fan in fluid communication with the air channel, the upright fan being operatively adapted to move air through the air channel; a battery pack attached to the frame and positioned above a lower edge of the transparent face shield, the battery pack being operatively adapted to supply electrical power to the upright fan; and a hood surrounding the transparent face shield and extending over and downward from the frame.

According to yet a further exemplary embodiment of the present invention, the surgical helmet comprises a frame operatively adapted to surround at least a portion of a person's head; a transparent face shield attached to the frame and positioned along a front side of the helmet; an air channel having a single air channel inlet and a single air channel outlet, the single air channel outlet being positioned so as to provide air to a space bound by an inner surface of the transparent face shield; an upright fan in fluid communication with the air channel and positioned a distance from both the single air channel inlet and the single air channel outlet, the fan being operatively adapted to move air through the air channel; a hood surrounding the

transparent face shield and extending over and downward from the frame; a single hood air inlet located within a periphery of the hood and aligned with the single air channel inlet of the air channel; and at least one hood air outlet located within a periphery of the hood, wherein the single hood air inlet and the at least one hood air outlet are operatively adapted to provide air flow through the helmet so as to decrease an amount of carbon dioxide buildup within the helmet.

The present invention is also directed to a surgical outfit comprising at least one surgical helmet. In one exemplary embodiment, the surgical outfit comprises a surgical helmet, and a surgical gown sized so as to extend from a neck region of a user to a waist region or below, wherein the hood of the helmet is sized so as to extend below the neck region of the user, and when a lower portion of the hood is tucked within an upper portion of the surgical gown, at least one air outlet of the hood, when present, is positioned above the surgical gown. In this embodiment, the helmet may comprise one or more of the following components: (1) a frame operatively adapted to surround at least a portion of a person'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, the at least one air channel outlet being positioned so as to provide air to a space bound by (i) the face of a wearer and (ii) an inner surface of a transparent face shield when present; (3) a fan in fluid communication with the air channel, the fan being operatively adapted to move air through the air channel; and (4) a detachable or permanently attached surgical helmet cover assembly, wherein the surgical helmet cover assembly comprises (4a) a transparent face shield attached to the frame and positioned along a front side of the helmet; (4b) a hood comprising a first hood material having (i) a face shield aperture completely surrounded by the first hood material and sized so that an outer periphery of the face shield aperture surrounds the transparent face shield, (ii) at least one hood air inlet completely surrounded by the first hood material and positioned to align with the at least one air channel inlet, (iii) at least one hood air outlet completely surrounded by the first hood material and positioned on a rear portion of the hood opposite the transparent face shield, and (iv) a hood opening completely surrounded by the first hood material, the hood opening sized so that the hood can be positioned over and onto the frame, the air channel and the fan; and (4c) multiple pieces of additional hood material positioned over the at least one hood air inlet and the at least one hood air outlet, wherein the multiple pieces of additional hood material (i) are bonded to the first hood material along an outer periphery of each of the at least one hood air inlet and the at least one hood air outlet, and (ii) have an air flow permeability greater than the first hood material.

The present invention is further directed to methods of making surgical helmets and surgical helmet components. In one exemplary embodiment, the method of making a surgical helmet component comprises making a surgical helmet cover assembly, wherein the method comprises providing a hood comprising (1) a first hood material having (i) a face shield aperture along a front side of the hood and completely surrounded by the first hood material, (ii) at least one hood air inlet along an upper portion of the hood and completely surrounded by the first hood material, (iii) at least one hood air outlet along a rear side of the hood opposite the face shield aperture and completely surrounded by the first hood material, (iv) a hood opening completely surrounded by the first hood material, the hood opening sized so that the hood can be positioned over a surgical helmet; (2) a transparent face shield positioned within the face shield aperture and bonded to the first hood material along an outer periphery of the face shield aperture; and (3) multiple pieces of additional hood material positioned over the at least one hood air inlet and the at least one hood air outlet, wherein the multiple pieces of additional hood material (i) are bonded to the first hood material along an outer periphery of each of the at least one hood air inlet and the at least one hood air outlet, and (ii) have an air flow permeability greater than the first hood material. The exemplary method may further comprise a number of additional steps such as attaching the transparent face shield to the first hood material; attaching the multiple pieces of additional hood material to the first hood material; and attaching one or more attachment members to the first hood material and/or the transparent face shield. The resulting surgical helmet cover assembly may be detachable or permanently attached to a helmet frame.

In a further exemplary embodiment, the present invention is directed to a method of making a surgical helmet, wherein the method comprises providing a frame of a helmet, the frame being operatively adapted to surround at least a portion of a person'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 so as to provide air to a space bound by (i) the face of a wearer and (ii) an inner surface of a transparent face shield when present, the foam member being attached to or integrally formed into the frame; and providing a fan in fluid communication with the air channel, the fan being operatively adapted to move air through the air channel.

The present invention is even further directed to methods of using a surgical helmet or helmet component in an operating room setting. In one exemplary embodiment of the present invention, the method comprises providing a helmet or helmet component such as one of the above-described helmets or helmet components; and cutting on' the fan to provide an air flow

path from into the at least one hood air inlet, to the at least one air channel inlet, through the air channel, out of the at least one air channel outlet into a region of the helmet bound by the transparent face shield, and out of the helmet through the at least one hood air outlet. The above-described surgical helmets or helmet components provide controlled directional air flow through a given surgical helmet so as to minimize carbon dioxide build-up within the surgical helmet.

The present invention is even further directed to methods of reducing an amount of carbon dioxide within a surgical outfit during use. In one exemplary embodiment, the method comprises providing a surgical outfit of the present invention (such as the above-described surgical outfit or any surgical outfit described below), and cutting on the fan to provide an air flow path through at least one hood air inlet in a helmet, to at least one air channel inlet, through an air channel, out of at least one air channel outlet into a region of the helmet bound by a transparent face shield, and out of the helmet through at least one hood air outlet. The surgical outfit of the present invention is capable of reducing an amount of carbon dioxide within the surgical outfit, 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 after a review of the following detailed description of the disclosed embodiments and the appended claims.

BRIEF DESCRIPTION OF THE FIGURES

. The present invention is further described with reference to the appended figures, wherein:

FIG. 1 depicts a side view of an exemplary surgical helmet cover assembly of the present invention; FIG. 2A depicts a frontal view of the exemplary surgical helmet cover assembly shown in FIG. 1;

FIG. 2B depicts a rear view of the exemplary surgical helmet cover assembly shown in FIG. 1;

FIG. 3 depicts a cross-sectional view of the exemplary surgical helmet cover assembly of FIG. 1 as viewed perpendicularly to plane A-A shown in FIG. 1;

FIG. 4 depicts a side view of an exemplary surgical helmet of the present invention; FIG. 4A depicts a top view of the exemplary surgical helmet shown in FIG. 4 as viewed from above the exemplary surgical helmet;

FIG. 4B depicts a cross-sectional view of the exemplary surgical helmet shown in FIG. 4 as viewed perpendicularly to plane B-B shown in FIG. 4;

FIG. 4C depicts a close-up view of the exemplary surgical helmet shown in FIG. 4 when viewed from below the helmet;

FIG. 4D depicts a cross-sectional view of the exemplary surgical helmet shown in FIG. 4 as viewed within plane B-B shown in FIG. 4; FIG. 5 depicts a side view of an exemplary helmet of the present invention;

FIG. 6 depicts a rear view of the exemplary helmet of FIG. 5;

FIG. 7 depicts a close-up rear view of the exemplary helmet of FIG. 5;

FIG. 8 depicts a view of the exemplary helmet of FIG. 5 when viewed from below the helmet; FIG. 9 depicts a close-up view of the frame, air channel, battery pack, and fan of the exemplary helmet of FIG. 5 when viewed from below the helmet;

FIG. 1OA depicts a side view of the exemplary helmet of FIG. 5 when the hood is removed;

FIG. 1OB depicts a side view of another exemplary helmet shown without a hood component; and

FIG. 11 depicts an exemplary surgical outfit comprising the exemplary helmet of FIG. 5 in combination with a surgical 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 used including, but not limited to, an operating room setting, an emergency room setting, a hospital setting, a lab, a clean room, etc. The present invention is further directed to methods of making surgical helmets and surgical helmet components and methods of using surgical helmets and surgical helmet components in an operating room setting or any of the above-mentioned environments. The surgical helmets and surgical helmet components of the present invention are particularly useful in providing a barrier between a surgeon and a surgical site of a patient.

/. Surgical Helmets and Surgical Helmet Components In one exemplary embodiment of the present invention, the present invention is directed to a surgical helmet cover assembly comprising a hood sized to extend over a surgical helmet, the hood comprising a first hood material having (i) a face shield aperture completely surrounded by the first hood material, (ii) at least one hood air inlet completely surrounded by the first hood material, (iii) at least one hood air outlet completely surrounded by the first hood material, and (iv) a hood opening completely surrounded by the first hood material, the hood

opening being sized so that the hood can be positioned over and onto a surgical helmet; a transparent face shield positioned over the face shield aperture and bonded to the first hood material along an outer periphery of the face shield aperture so as to form a sterile barrier along the outer periphery between an interior volume of the hood and an exterior surface of the hood; and multiple pieces of additional hood material positioned over the at least one hood air inlet and the at least one hood air outlet, wherein the multiple pieces of additional hood material (i) are bonded to the first hood material along an outer periphery of each of the at least one hood air inlet and the at least one hood air outlet, and (ii) have an air flow permeability greater than the first hood material. An exemplary surgical helmet cover assembly is shown in FIG. 1. As shown in FIG. 1, exemplary surgical helmet cover assembly 100 comprises hood 101 sized to extend over a surgical helmet (not shown), wherein hood 101 comprises first hood material 102 having (i) a face shield aperture 103 completely surrounded by first hood material 102, (ii) at least one hood air inlet 104 completely surrounded by first hood material 102, (iii) at least one hood air outlet 105 completely surrounded by first hood material 102, and (iv) a hood opening 106 completely surrounded by first hood material 102. Hood opening 136 is sized so that hood opening 136 can be positioned over and onto a surgical helmet (not shown). Exemplary surgical helmet cover assembly 100 further comprises a transparent face shield 106 positioned over face shield aperture 103 and bonded to first hood material 102 along an outer periphery 107 of face shield aperture 103 so as to form a sterile barrier along outer periphery 107 between an interior volume (e.g., interior volume 108 shown in FIG. 3) of hood 101 and an exterior surface 109 of hood 101. Exemplary surgical helmet cover assembly 100 further comprises multiple pieces of additional hood material 110 and 111 positioned over the at least one hood air inlet 104 and the at least one hood air outlet 105 respectively, wherein each of the multiple pieces of additional hood material 110 and 111 (i) are bonded to first hood material 102 along an outer periphery 112 and 113 of each of the at least one hood air inlet 104 and the at least one hood air outlet 105 respectively, and (ii) have an air flow permeability greater than first hood material 102.

As shown in FIG. 1, hood 101 of exemplary surgical helmet cover assembly 100 may further comprise a resealable fan switch knob opening 124 completely surrounded by first hood material 102. When present, resealable fan switch knob opening 124 (i) is sized so that a fan switch knob of a surgical helmet (see, for example, fan switch knob 23 of exemplary surgical helmet 10 shown in FIG. 10B) can fit therethrough, and (ii) is positioned along an outer surface 140 of hood 101, desirably, above a lower edge 125 of transparent face shield 106, and more desirably, along an outer surface of hood 101 above transparent face shield 106.

FIG. 2A depicts a frontal view of exemplary surgical helmet cover assembly 100 shown in FIG. 1. As shown in FIG. 2A, transparent face shield 106 is positioned along a front side 114 of hood 101 over face shield aperture 103. Further, transparent face shield 106 is completely surrounded by first hood material 102. As shown in FIG. 2A, hood 101 may further comprises a resealable frame adjustment knob opening 121 completely surrounded by first hood material 102, wherein resealable frame adjustment knob opening 121 (i) is sized so that a frame adjustment knob of a surgical helmet (see, for example, frame adjustment knob 14 of exemplary surgical helmet 10 shown in FIG. 9) can fit therethrough, and (ii) is positioned along front side 114 of hood 101 and above transparent face shield 106. When exemplary surgical helmet cover assembly 100 is used in combination with a reuseable surgical helmet, hood 101 of exemplary surgical helmet cover assembly 100 does not have to comprise resealable frame adjustment knob opening 121 given that surgical helmet/frame adjustments are typically made on the helmet prior to attachment of exemplary surgical helmet cover assembly 100 to the surgical helmet.

Hood 101 of exemplary surgical helmet cover assembly 100 typically comprises a single hood air inlet 104 positioned along an upper rear portion 115 of hood 101, and one or more hood air outlets 105 positioned along a rear side 116 of hood 101 below single hood air inlet 104 and opposite transparent face shield 106 (e.g., in a neck region of the wearer). In one desired embodiment, hood 101 comprises two separate hood air outlets 105 positioned side-by-side along rear side 115 of hood 101 below single hood air inlet 104 and opposite transparent face shield 106 (i.e., instead of a single hood air outlet 105 as shown in FIG. 2B, two hood air outlets 105 would be present in a neck region of the wearer similar to hood air outlets 62 shown in FIG. 7).

As shown in FIG. 2B, hood 101 may further comprise a pocket 117 positioned along rear side 116 of hood 101, wherein pocket 117 is sized so as to accept a battery pack (not shown) therein. When present, pocket 117 may be positioned along any portion of an outer surface 140 of hood 101, although pocket 117 is desirably positioned below at least one hood air inlet 104 and below at least one hood air outlet 105 as shown in FIG. 2B. Although not shown in FIG. 2B, hood 101 may further comprise a slot in first hood material 102, wherein the slot is desirably positioned within pocket 117 and sized so that a battery pack connector (not shown) can extend through the slot. In some embodiments, pocket 117 may be used to store a supplemental battery, with a primary battery being positioned within a frame component or air channel containing member (e.g., foam member) of a surgical helmet as described further below.

FIG. 3 depicts a cross-sectional view of exemplary surgical helmet cover assembly 100 of FIG. 1 as viewed perpendicularly to plane A-A shown in FlG. 1. As shown in FIG. 3,

exemplary surgical helmet cover assembly 100 may further comprise one or more attachment members 118 positioned along (i) an inner surface 119 of hood 101, (ii) an inner surface 120 of transparent face shield 106, or (iii) both (i) and (ii). One or more attachment members 118 are operatively adapted to connect exemplary surgical helmet cover assembly 100 to a surgical helmet (for example, exemplary surgical helmet 200 shown in FlG. 4). Attachment members 118 may comprise a variety of materials including, but not limited to, hook and/or loop material, magnets, adhesive tape, etc.

As shown in FIG. 3, exemplary surgical helmet cover assembly 100 may further comprise one or more adjustable face shield spacers 127 positioned along an inner surface 120 of transparent face shield 106. When present, the one or more adjustable face shield spacers 127 are operatively adapted to alter a line of curvature extending from one side of transparent face shield 106 (i.e., side 128 shown in FIG. 2A) to an opposite side of transparent face shield 106 (i.e., side 129 shown in FIG. 2A). Any member (e.g., a screw-like member) capable of adjusting a distance between transparent face shield 106 and a surgical helmet component, for example, as a frame or air channel containing member (described further below), may be used for each adjustable face shield spacer 127. Alteration of the line of curvature of transparent face shield 106 may help reduce an amount of glare when viewing a surgical site through transparent face shield 106.

First hood material 102 (and pocket 117, when present) typically comprises a fluid/blood barrier material. The fluid/blood barrier material typically comprises a single layer of nonwoven fabric or a single layer of nonwoven fabric/film laminate having little or no air permeability. Typically, the fluid/blood barrier material has an air permeability (i.e., as measured using ASTM D737 test method) of less than about 17.1 cm ³ /min/cm ² of material (0.562 ft ³ /min/ft ² of material). In one desired embodiment, the fluid/blood barrier material comprises a breathable viral barrier (BVB) fabric commercially available from Ahlstrom Corporation (Alpharetta, GA), such as a BVB trilaminate polypropylene material having a basis weight of about 70 grams per square meter (gsm) and a thickness of about 0.35 millimeters (mm).

Multiple pieces of additional hood material 110 and 111 (also referred to herein as "air filtration material") may comprise a variety of air filtration (i.e., air permeable) materials. Typically, each of multiple pieces of additional hood material 110 and 111 comprises a nonwoven fabric, such as a spunbonded fabric, a spunlaced fabric, a needle-punched fabric, a melt-blown fabric, or any combination thereof. In one desired embodiment, each of multiple pieces of additional hood material 110 and 111 comprises a spunbonded fabric, such as a nylon spunbonded fabric commercially available under the trade designation CEREX ^® from Cerex

Advanced Fabrics, Inc. (Pensacola, FL).

Typically, each of multiple pieces of additional hood material 110 and 111 comprises a nonwoven fabric having a fabric basis weight of less than 100 gsm (more typically, from about 9 gsm to about 95 gsm, even more typically, from about 15 gsm to about 50 gsm) and a fabric thickness of less than about 150 microns (μm), typically, from about 75 μm to about 100 μm. In contrast, first hood material 102 typically comprises one of the above-mentioned fluid/blood barrier materials having a basis weight of greater 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 greater than about 0.25 mm, typically, from about 0.35 mm to about 0.5 mm. The above-described surgical helmet cover assemblies of the present invention are typically disposable, and may be used with disposable or reuseable surgical helmets of the present invention such as the surgical helmets described below. One exemplary surgical helmet of the present invention is shown in FIG. 4.

As shown in FIG. 4, exemplary surgical helmet 200 of the present invention comprises a frame 201 operatively adapted to surround at least a portion of a person's head (not shown); an air channel containing member 202 (e.g., a foam member) having an air channel therein (see, air channel 210 in FIG. 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 so as to provide air to a space bound by (i) the face of a wearer (not shown) and (ii) an inner surface of a transparent face shield (not shown) when present; and a fan (see, fan 213 in FIG. 4A) in fluid communication with the air channel (not shown), the fan being operatively adapted to move air through the air channel of air channel containing member 202.

As shown in FIG. 4, exemplary surgical helmet 200 may further comprise a frame adjustment knob 205 that can be used to adjust the dimensions of frame 201 so as to better fit onto the head of a user (not shown). Knob 205 can be used to adjust a length (i.e., a first dimension extending from front side 206 to rear side 207) and a width of frame 201 (i.e., a dimension extending perpendicular to the first dimension, e.g., across a width of exemplary surgical helmet 200). Exemplary surgical helmet 200 may further comprise a fan adjustment knob 205 that can be used to (i) cut "on" or "off' the fan, (ii) change a speed of the fan, or (iii) both (i) and (ii).

Exemplary surgical helmet 200 may further comprise frontal pad 209 and rear pad 211 along opposite ends of frame 201 to provide additional comfort to a user (not shown). In addition, exemplary surgical helmet 200 may further comprise one or more adjustable helmet spacers 227, which, like adjustable face shield spacers 127 described above, are operatively

adapted to alter a line of curvature extending from one side of a transparent face shield to an opposite side of transparent face shield so as to help reduce an amount of glare when viewing a surgical site through the transparent face shield.

Exemplary surgical helmet 200 may be used in combination with a detachable or permanently attached surgical helmet cover assembly, such as exemplary surgical helmet cover assembly 100 discussed above. As shown in FIG. 4, exemplary surgical helmet 200 may comprise one or more attachment members 218 that assist in attaching a surgical helmet cover assembly, such as exemplary surgical helmet cover assembly 100 discussed above, to exemplary surgical helmet 200. For example, attachment members 118 of exemplary surgical helmet cover assembly 100 shown in FIG. 3 and attachment members 218 of exemplary surgical helmet 200 may comprise, for example, hook and loop material, respectively, to aid in the attachment of exemplary surgical helmet cover assembly 100 to exemplary surgical helmet 200. In other embodiments, attachment members 118 and 218 may comprise magnets, adhesive tape, or any other type of attachment material. FIG. 4A depicts a top view of exemplary surgical helmet 200 shown in FIG. 4 as viewed from above exemplary surgical helmet 200. As shown in FIG. 4A, air channel containing member 202 has at least one air channel inlet 203 positioned along 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 within slot 212 and is operatively adapted to move air through the air channel of air channel containing member 202 in a direction as shown by arrow A in FIG. 4A. As shown in FIG. 4A, air channel containing member 202 may further comprise an indention 215 sized to house a primary battery pack (not shown) for supplying electricity to fan 213.

FIG. 4B depicts a cross-sectional view of exemplary surgical helmet 200 shown in FIG. 4 as viewed perpendicularly to plane B-B shown in FIG. 4 so as to show air channel 210. As shown in FIG. 4B, air channel 210 of air channel containing member 202 extends from at least one air channel inlet 203 positioned along an upper rear portion 214 of air channel containing member 202 to air channel outlet 204 positioned along a front portion 216 of air channel containing member 202. Slot 212, which is sized so as to house fan 213 (not shown), desirably has a width slightly greater than a width of air channel 210 and a height slightly greater than a height of air channel 210, so that fan 213 fits snugly within slot 212 and does not move out of slot 212 during operation. When air channel containing member 202 comprises a foam member as discussed further below, slot 212 of air channel containing member 202 also absorbs any

undesirable vibration of fan 213 positioned within slot 212. In necessary, an additional piece of material (e.g., foam) (not shown) may be used to snugly position fan 213 within slot 212.

Although not shown in FIG. 4B, desirably fan 213 is in an upright position within slot

212. In other words, desirably, fan 213 is positioned within slot 212 of air channel 210 so that fan blades of fan 213 move in a plane that is substantially perpendicular to a direction of air flow through air channel 210 (i.e., in a plane substantially perpendicular to a direction of air flow as shown by arrow A).

As discussed further below, air channel containing member 202 may further comprise one or more openings 220 within air channel containing member 202. Openings 220 may be present to further reduce an overall weight of air channel containing member 202. Any number of openings 220 may be present within air channel containing member 202 as long as air channel containing member 202 maintains sufficient structural integrity for supporting the various components of the disclosed surgical helmets.

As shown FIG. 4B, air channel containing member 202 may comprise indentation 215 for housing a battery pack (not shown). Desirably, a battery pack (not shown) is positioned within indentation 215 and attached to air channel containing member 202 and/or frame 201 and positioned above a lower edge of a transparent face shield (not shown), wherein the battery pack is operatively adapted to supply electrical power to fan 213. As discussed above, a supplemental battery pack may be positioned within a pocket (e.g., pocket 117) along an outer surface of a hood (e.g., hood 101) used in combination with exemplary surgical helmet 200.

FIG. 4C depicts a close-up view of exemplary surgical helmet 200 shown in FIG. 4 when viewed from below exemplary surgical helmet 200. As shown in FIG. 4C, exemplary surgical helmet 200 further comprises straps 221 extending from opposite sides of frame 201 and/or opposite sides of an inner surface 223 (or an outer surface 257) of air channel containing member 202. Straps 221 help support exemplary surgical helmet 200 on the head of a user (not shown). As discussed above, frame 201 along with frame adjustment knob 205 (not shown) may be used to adjust an overall length of frame loop 231 extending between points X and Y as shown in FIG. 4C. By turning frame adjustment knob 205 (not shown), loop length adjuster 251 either (1) moves portions of frame loop 231 (e.g., loop portions at points X and Y) toward one another to decrease an overall length of frame loop 231 or (2) moves portions of frame loop 231 (e.g., loop portions at points X and Y) away from one another to increase an overall length of frame loop 231.

In one exemplary embodiment, air channel containing member 202 comprises a foam member. In this exemplary embodiment, air channel containing member 202 may comprise an

upper foam member 240 and a lower foam member 241 attached to one another. As shown FIG. 4C, upper foam member 240 having lower edge 224 in combination with lower foam member 241 having lower edge 222 form air channel 210 positioned between inner surface 228 of upper foam member 240 and inner surface 229 of lower foam member 241. As shown FIG. 4C, lower foam member 241 is operatively adapted to surround at least a portion of a person's head (not shown). As discussed above, frame 201 (and portions thereof) may be attached to lower foam member 241 along inner surface 223, outer surface 257, lower edge 222, or any combination thereof using mechanical fasteners or adhesives. Further, as discussed above, lower foam member 241 may comprise one or more openings/apertures 220 therein to reduce an overall weight of lower foam member 241.

In one exemplary embodiment, upper foam member 240 and lower foam member 241 comprise attachment features that enable upper foam member 240 and lower foam member 241 to be attached to one another without the use of an additional fastening material. For example, upper foam member 240 and lower foam member 241 may snap together upon application of an attachment force. An example of such a configuration is shown in FIG. 4D.

FIG. 4D depicts a cross-sectional view of exemplary air channel containing member 202 as viewed within plane B-B and along line E-E as shown in FIG. 4. As shown in FIG. 4D, exemplary air channel containing member 202 comprises upper foam member 240 comprising female attachment members 244 along lower section 248, and male attachment members 245 along upper section 247 lower foam member 241. Female attachment members 244 and male attachment members 245 enable attachment of upper and lower foam members 240 and 241 respectively to be attached to one another without the use of an additional fastening material

(e.g., an adhesive). In other embodiments, other desirable attachment members having different configurations may be used, as well as additional fastening materials (e.g., an adhesive) if so desired.

As shown in FIG. 4D, slot 212 for fan 213 (not shown) extends across indentation section 212A of upper foam member 240, as well as indentation section 212B of lower foam member 241. As discussed above, desirably, fan 213 fits snugly within slot 212 in an upright position to reduce fan vibration, movement, noise, or any combination thereof. Although shown as only covering a portion of a cross-sectional area of air channel 210, it should be noted that fan 213 may extend across fits air channel 210 so as to cover all of the cross-sectional area of air channel 210 or any portion thereof.

Exemplary air channel containing member 202 comprising upper foam member 240 and lower foam member 241 provides a lightweight air channel formed from foam suitable foam

material. In one exemplary embodiment, each of upper and lower foam members 240 and 241 comprise a molded closed cell polyurethane foam.

Another exemplary surgical helmet 10 is shown in FIG. 5. As shown in FIG. 5, exemplary surgical helmet 10 comprises a transparent face shield 11 along a front side 20 of helmet 10, and a hood 12 surrounding an outer periphery 13 of transparent face shield 11 and extending over and downward from a frame of helmet 10 (e.g., frame 30 shown in FIG. 10 below). Exemplary surgical helmet 10 further comprises knob 14 that can be used to adjust the dimensions of the frame so as to better fit onto the head of a user. Knob 14 can be used to adjust a length (i.e., a first dimension extending from front side 20 to rear side 21) and a width of the frame (i.e., a dimension extending perpendicular to the first dimension, e.g., across transparent face shield 11). Exemplary surgical helmet 10 further comprises damper knob 15, which can be used to adjust a damper positioned within a vicinity of an air outlet into the helmet. (See, for example, damper 72 in FIG. 9, which is shown in an "up" position, but can be rotated into a "down" position away from wall 73 of frame component 33, in the direction as indicated by the arrow "D", to block air flow coming out of air outlet 28.)

Exemplary helmet 10 further comprises an air channel containing member comprising an air channel extending along upper region 17 of helmet 10 and having at least one air inlet (e.g., air inlet 22 shown in FIG. 6) and at least one air outlet (e.g., air outlet 28 shown in FIG. 8), wherein the at least one air outlet is positioned so as to provide air to a space 60 bound by an inner surface of transparent face shield 11. A fan (e.g., fan 27 shown in FIG. 8 below) is in fluid communication with the air channel, and is operatively adapted to move air through the air channel.

As shown in FIG. 5, in some desired embodiments of the present invention, exemplary hood 12 of exemplary helmet 10 comprises (i) at least one hood air inlet 16 located within a periphery of hood 12 and aligned with the at least one air inlet (e.g., air inlet 22 shown in FIG. 6) of the air channel, and (ii) at least one hood air outlet 18 located within a periphery of hood 12. Hood air inlet 16 and hood air outlet 18 are operatively adapted to provide air flow through helmet 10 so as to decrease an amount of carbon dioxide buildup within helmet 10. Desirably, hood air inlet(s) 16 and hood air outlet(s) 18 are positioned along a rear side 21 of helmet 10 opposite transparent face shield 11 (see, for example, FIG. 6); however, it should be understood that hood air inlet(s) 16 and hood air outlet(s) 18 may be positioned along any location of helmet 10 as long as hood air inlet(s) 16 and hood air outlet(s) 18 provide air flow through helmet 10 so as to decrease an amount of carbon dioxide buildup within helmet 10.

FlG. 6 provides a rear view of exemplary helmet 10. As shown in FIG. 6, exemplary

hood 12 of exemplary helmet 10 comprises (i) a single hood air inlet 16 located within a periphery of hood 12, and (ii) two substantially similar hood air outlets 18 and 19 located within a periphery of hood 12, below hood air inlet 16, and positioned side-by-side along a neck region of hood 12. As shown in FIG. 6, hood air inlet 16 is located within a periphery of the hood and aligned with air inlet 22 of air channel 25. Hood air outlets 18 and 19 are located within a periphery of the hood, and positioned below hood air inlet 16. In this exemplary embodiment, air enters helmet 10 at a position above a user's head, and exits helmet 10 along a neck region of the user as designated by dashed line L-L. Exemplary hood 12 extends below dashed line L-L to lower edge 24 of hood 12. In the exemplary embodiment of FIG. 6, exemplary helmet 10 comprises a power switch

23 positioned along upper region 17 of helmet 10. Power switch 23 is operatively adapted to switch from an "off' position to an "on" position so as to supply power to the fan (e.g., fan 27 shown in FIG. 8 below) and turn off power to the fan. In other exemplary embodiments, power switch 23 is provided in other locations such as a position along an upper periphery of transparent face shield 11 (see, for example, power switch 23 shown in FIG. 10).

FIG. 7 provides a rear close-up view of exemplary helmet 10. As shown in FIG. 7, a first air filtration material 61 forms hood air inlet 16 of exemplary hood 12, and a second air filtration material 62 forms hood air outlets 18 and 19 of exemplary hood 12. First air filtration material 61 and second air filtration material 62 may comprise a variety of filtration materials such as the materials described above for the multiple pieces of additional hood material 110 and 111. In one desired embodiment, each of first and second air filtration materials 61 and 62 comprises a spunbonded fabric, such as a nylon spunbonded fabric commercially available under the trade designation CEREX ^® from Cerex Advanced Fabrics, Inc. (Pensacola, FL).

The remaining portions of hood 12 (i.e., all of hood 12 other than hood air inlet 16 and hood air outlets 18 and 19) typically comprise a fluid/blood barrier material such as the fluid/blood barrier materials described above for first hood material 102. In one desired embodiment, hood 12 comprises any breathable viral barrier (BVB) fabric commercially available from Ahlstrom Corporation (Alpharetta, GA), such as a BVB trilaminate polypropylene material. FIG. 8 provides a view of exemplary helmet 10 of FIG. 5 when viewed from below helmet 10 (e.g., when viewed from position V shown in FIG. 5). As shown in FIG. 8, exemplary helmet 10 comprises frame 30, which is operatively adapted to surround at least a portion of a person's head (not shown). Frame 30 typically comprises one or more frame components. In exemplary helmet 10, frame 30 comprises the following frame components:

adjustable frame component 31, which extends around at least a portion of a person's head and can be adjusted in length and width dimensions using knob 14 as described above; frame component 32, which at least partially surrounds transparent face shield 11 and attaches transparent face shield 11 to other helmet components; frame component 33, which extends along a front side 20 of exemplary helmet 10 and connects adjustable frame component 31 to frame component 32; knob extension member 37 extending along a portion of frame component 33 and being rotatably connected to knob 14; and frame component 34, which extends from a first location 65 along adjustable frame component 31 to a second location 66 along adjustable frame component 31 and is operatively adapted to conform to an outer contour of a person's head.

As shown in FIG. 8, exemplary helmet 10 may further comprise pads 35 positioned along one or more of the above-described frame components. As shown in FIG. 8, exemplary helmet 10 comprises multiple pads 35 positioned along adjustable frame component 31 and a single pad 35 positioned along frame component 34. FIG. 8 provides a view of a battery pack 26 that is present in some helmets of the present invention. As shown in FIG. 8, exemplary battery pack 26 is positioned along opposite sides of air channel 25. Electrical wiring (not shown) connects battery pack 26 to fan 27 and power switch 23 (shown in FIGS. 6 and 10). Although shown on opposite sides of air channel 25, it should be understood that battery pack 26 may be located along any portion of frame 30. Desirably, as shown in FIGS. 8-10, battery pack 26 is located above a lower edge of the transparent face shield, more desirably, above an upper portion of the transparent face shield and along one or both sides of air channel 25.

FIG. 9 provides a close-up view of various helmet components within exemplary helmet 10. As shown in FIG. 9, exemplary helmet 10 comprises air channel 25 extending between air inlet 22 and air outlet 28. Battery pack 26 is positioned along opposite sides of air channel 25. Electrical wiring 39 connects battery pack 26 to fan 27 and power switch 23 (shown in FIGS. 6 and 10). As shown in FIG. 9, fan 27 is positioned within air channel 25 in the vicinity of air outlet 28. However, it should be understood that fan 27 may be positioned at any location within air channel 25 or at air inlet 22. Damper 72 is positioned adjacent wall 73 of frame component 33 in an "up" position, but can be rotated into a "down" position away from wall 73 and over air outlet 28 to block and/or redirect air flow through helmet 10. The degree of air blockage and air flow direction can be controlled by rotating knob 15 as discussed above.

FIG. 1OA provides a side view of exemplary helmet 10 of FIG. 5 when hood 12 is removed. As shown in FIG. 1OA, exemplary helmet 10 comprises adjustable frame component

31 dimensioned so as to extend around at least a portion of a person's head; knobs 14 and 15, which are operatively adapted to adjust dimensions of adjustable frame component 31 and air flow through the helmet respectively; frame component 32 partially surrounding transparent face shield 11; frame component 34, which is operatively adapted to conform to an outer contour of a person's head; battery pack 26; fan 27; air channel 25; air inlet 22; air outlet 28; electrical wiring 40 connecting battery pack 26 to fan 27; and power switch 23.

FIG. 1OB provides a side view of another exemplary helmet 10 without a hood component. As shown in FIG. 1OB, exemplary helmet 100 comprises molded helmet component 78; knob 14, which is operatively adapted to adjust dimensions of a frame component (not shown but similar to adjustable frame component 31 shown in FIG. 10A) extending around at least a portion of a person's head; frame component 32 partially surrounding transparent face shield 11; frame component 34, which is operatively adapted to conform to an outer contour of a person's head; battery pack 26; fan 27; air channel 25; air inlet 22; air outlet 28; electrical wiring connecting battery pack 26 to fan 27 (not shown, but typically within or along an inner surface of helmet component 78); and power switch/knob 23, which is operatively adapted to provide electricity to the fan and adjust the fan speed (i.e., air flow through the helmet).

As shown in FIG. 6B, fan 27 can be positioned near air inlet 22 of air channel 25. Further, battery pack 26 can be positioned along a rear outer surface of helmet component 78. Although power switch/knob 23 is shown as a single switch/knob on exemplary helmet 100, it should be understood that a separate on/off switch and a separate air speed control knob could be present on exemplary helmet 100. As discussed above, multiple air inlets 22 and/or air outlets 28 could be utilized on exemplary helmet 100 to provide air flow through exemplary helmet 100. Further, one or more air inlets 22 and/or air outlets 28 can be positioned on exemplary helmet 100 in any desired locations so as to provide air flow through exemplary helmet 100.

In one exemplary embodiment, any of the above-described helmets are sterilized prior to use. For example, in an operating room setting, a sterile field must be maintained around a surgical procedure site. Consequently, a surgical helmet used during such a surgical procedure must be sterilized prior to use. Typically, the helmets of the present invention are disposable. However, in some cases, the helmets of the present invention may be reusable. When reused, the helmet may need to be subjected to a cleaning procedure and/or sterilization procedure prior to reuse.

The present invention is also directed to a surgical outfit comprising at least one helmet. An exemplary surgical outfit is shown in FIG. 7. As shown in FIG. 7, exemplary surgical outfit

70 comprises exemplary surgical helmet 10 (or exemplary surgical helmet 200 in combination with exemplary surgical helmet cover assembly 100) in combination with surgical gown 50. Surgical gown 50 is sized so as to extend from a neck region of a user to a waist region of the user or below. Hood 12 of surgical helmet 10 (or hood 101 of exemplary surgical helmet cover assembly 100) is sized so as to extend below the neck region of the user. In one desired configuration shown in FlG. 7, a lower portion 120 of hood 12 (outlined with dash line M-M) is tucked within an upper portion 52 of surgical gown 50. Desirably, when at least one air outlet 18 is present in hood 12 (or hood 101 of exemplary surgical helmet cover assembly 100), the at least one air outlet 18 is positioned above upper edge 51 of surgical gown 50. In such a configuration, upper portion 52 of surgical gown 50 effectively blocks air flow into surgical gown 50 and out through the at least one air outlet 18.

It should be noted that surgical helmets 10 and 200 as shown in FIGS. 1-7 are only two exemplary surgical helmets of the present invention. Various modifications could be made to exemplary surgical helmets 10 and 200 including, but not limited to, increasing the number of hood air inlet(s) 16 (or hood air inlet(s) 104) and/or the number of hood air outlets 18 and 19 (or hood air outlet(s) 105); increasing or decreasing the size of one or more components (e.g., transparent face shield 11 and/or hood air inlet(s) 16 and/or hood air outlets 18 and 19) relative to other components (e.g., hood 12); and rearranging one or more components of exemplary helmets 10 and 200 (e.g., changing the position of fan 27 to a position closer to air inlet 22 and/or changing the position of hood air outlets 18 and 19 so as to be closer to transparent face shield 11 and/or further away from hood air inlet(s) 16).

Typically, surgical helmets of the present invention comprise from one to about five hood air inlet(s) 16 (or hood air inlet(s) 104), from one to about five hood air outlets 18 and 19 (or hood air outlet(s) 105), a single fan 27 (or fan 213), and a single air channel 25 (or air channel 210); however, surgical helmets of the present invention could comprise, for example, multiple fans and/or multiple air channels.

//. Methods of Making Surgical Helmets and Surgical Helmet Components

The present invention is further directed to methods of making surgical helmets and surgical helmet components such as the above-described surgical helmets and surgical helmet components. In one exemplary embodiment, the present invention is directed to a method of making a surgical helmet component comprising a surgical helmet cover assembly, wherein the method comprises providing a hood comprising (1) a first hood material having (i) a face shield aperture along a front side of the hood and completely surrounded by the first hood material, (ii) at least one hood air inlet along an upper portion of the hood and completely surrounded by the

first hood material, (iii) at least one hood air outlet along a rear side of the hood opposite the face shield aperture and completely surrounded by the first hood material, (iv) a hood opening completely surrounded by the first hood material, the hood opening sized so that the hood can be positioned over a surgical helmet; (2) a transparent face shield positioned within the face shield aperture and bonded to the first hood material along an outer periphery of the face shield aperture; and (3) multiple pieces of additional hood material positioned over the at least one hood air inlet and the at least one hood air outlet, wherein the multiple pieces of additional hood material (i) are bonded to the first hood material along an outer periphery of each of the at least one hood air inlet and the at least one hood air outlet, and (ii) have an air flow permeability greater than the first hood material.

The exemplary method of making a surgical helmet component may further comprise one or more of the following exemplary steps: attaching the transparent face shield to the first hood material; attaching the multiple pieces of additional hood material to the first hood material; attaching one or more attachment members onto an inner surface of the first hood material and/or the transparent face shield (e.g., attachment members 118); attaching one or more face shield spacers onto an inner surface of the first hood material and/or the transparent face shield (e.g., spacer members 127); cutting one or more apertures within the first hood material; attaching a pocket (e.g., pocket 117) onto an outer surface of the first hood material; and either temporarily or permanently attaching the resulting surgical helmet component (e.g., exemplary surgical helmet cover assembly 100) to a surgical helmet (e.g., exemplary surgical helmet 200).

In a further exemplary embodiment, the present invention is directed to a method of making a surgical helmet, wherein the method comprises providing a frame of a helmet, the frame being operatively adapted to surround at least a portion of a person'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 so as to provide air to a space bound by (i) the face of a wearer and (ii) an inner surface of a transparent face shield when present, the air channel being attached to or integrally formed into the frame; and providing a fan in fluid communication with the air channel, the fan being operatively adapted to move air through the air channel.

The exemplary method of making a surgical helmet may further comprise a number of additional steps including, but not limited to, forming one or more molded components for forming an air channel containing member (e.g., air channel containing member 202); attaching two or more components to one another (e.g., upper and lower foam members 240 and 241) to

form an air channel containing member; providing the above-described surgical helmet cover assembly, wherein the surgical helmet cover assembly may be detachable or permanently attached to the helmet frame; attaching the above-described surgical helmet cover assembly to the surgical helmet; incorporating a battery pack into the helmet so as to be positioned above a lower edge of the transparent face shield, the battery pack being operatively adapted to supply electrical power to the fan; and positioning a fan (e.g., fan 213) within an air channel so that the fan is a distance from the air inlet(s) and air outlet(s) of the air channel.

In a further exemplary embodiment, the method of making a helmet comprises providing a frame of a helmet, the frame being operatively adapted to surround at least a portion of a person's head; attaching a transparent face shield to the frame so as to be positioned along a front side of the helmet; providing an air channel containing member (e.g., a foam air channel containing member formed from upper and lower foam members 240 and 241) having at least one air inlet and at least one air outlet the air channel being attached to or integrally formed into the frame; providing a fan in fluid communication with the air channel, desirably, in an upright position, the fan being operatively adapted to move air through the air channel; providing a hood such as the above-described hood (e.g., hood 101) that surrounds the transparent face shield and extends over and downward from the frame; and optionally incorporating a battery pack into the helmet, the battery pack being operatively adapted to supply electrical power to the fan. Desirably, the at least one air outlet is positioned so as to provide air to a space bound by an inner surface of the transparent face shield. In other desired embodiments, the battery pack, when present, is positioned above a lower edge of the transparent face shield, more desirably, above an upper edge of the transparent face shield. Further, an additional battery pack may be provided in a pocket along an outer surface (e.g., a rear surface) of the hood.

In another exemplary embodiment, the method of making a helmet comprises providing a frame of a helmet, the frame being operatively adapted to surround at least a portion of a person's head; attaching a transparent face shield to the frame so as to be positioned along 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 attached to or integrally formed into the frame; providing a fan in fluid communication with the air channel, the fan being operatively adapted to move air through the air channel; and attaching a hood to the frame so as to surround the transparent face shield and extend over and downward from the frame, the hood comprising the above-described hood (e.g., hood 101), wherein the at least one hood air inlet and the at least one hood air outlet (in combination with the above-described fan, e.g., fan 213) are operatively adapted to provide air flow through the helmet so as to decrease an amount of carbon dioxide buildup within the

helmet. Desirably, the at least one air outlet is positioned so as to provide air to a space bound by an inner surface of the transparent face shield.

Any of the above -described individual components used to form the helmets and helmet components of the present invention may be formed using 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, knob extension member 37, knobs 14 and 15, air channel containing member 25 or 202, and transparent face shield 11 or 206, may be formed from any thermoformable material including, but not limited to, polymeric materials, metallic materials, or a combination thereof. The thermoformable materials can be molded or shaped using any conventional molding technique. Typically, the above-mentioned helmet components are formed from polymeric materials such as polyolefins (e.g., polyethylene, polypropylene, and olefin copolymers), polyurethanes, acrylonitrile-butadiene-styrene (ABS) copolymers, polyesters, polyethylene terephthalate glycol (PETG), polyamides, etc. Any films or film-like components including, but not limited to, adjustable frame component 31, frame component 34 and frame component 201 may be forming via any film- forming process including, but not limited to, a film extrusion process, a film-blowing process, etc.

Fiber-containing helmet components, such as hood 12 or hood 101, first and second air filtration materials 61 and 62, and multiple pieces of additional hood material 110 and 111 may be formed using conventional web-forming processes including, but not limited to, meltblowing processes, spunbonding processes, spunlacing processes, hydroentangling processes, carding processes, needlepunching processes, etc. Typically, the fiber-containing helmet components are formed from polymeric materials such as polyolefins (e.g., polyethylene, polypropylene, and olefin copolymers), nylon, acrylonitrile-butadiene-styrene (ABS) copolymers, etc.

Thermoformed parts, films and/or fabric layers may be joined to one another using any conventional bonding technique including, but not limited to, thermal bonding processes, adhesive bonding, mechanical bonding (e.g., hook and loop material), etc. In one exemplary embodiment of the present invention, the hood is formed from an Ahlstrom Corporation BVB Material (e.g., trilaminate polypropylene material) and is thermally bonded to an outer periphery of a transparent face shield formed from PETG using a conventional thermal-bonding apparatus (e.g., an ultrasound welder).

In one desired embodiment, the surgical helmets and helmet components of the present invention are formed from the following materials: a closed cell polyurethane foam molded

helmet component (e.g., helmet component 78 and upper and lower foam members 240 and 241); frame components (e.g., frame component 201 shown in FIG. 4 and adjustable frame component 31 shown in FIG. 6A) formed from polyethylene; a transparent face shield (e.g., transparent face shield 11 or 106) formed from PETG; a frame component extending around the transparent face shield, when present, (e.g., frame component 32) formed from polyvinyl chloride (PVC); head band material in the form of VELCRO ^® brand terry cloth; batteries - 4 AAA Alkaline batteries; and air inlet and outlet material formed from CEREX ^® nylon spunbonded fabric.

///. Methods of Using Surgical Helmets and Surgical Helmet Components

The present invention is further directed to methods of using the above-described helmets in an operating room setting. In one exemplary embodiment, the method comprises a method of providing a barrier between a surgeon (or other operating room personnel) and a patient in an operating room setting, wherein the method comprises the step of positioning the helmet over at least a portion of the surgeon's head (or any other operating room personnel's head) to separate the surgeon (or other operating room personnel) from a surgical procedure site. Typically, the helmet is used in combination with a surgical gown and other pieces of protective clothing (e.g., booties, gloves, etc.) to provide a barrier between the surgeon and a surgical procedure site. In another exemplary embodiment, the present invention is directed to a method of reducing an amount of carbon dioxide within a surgical outfit during use. In this exemplary embodiment, the method comprises (A) providing a surgical outfit comprising (1) a helmet comprising (i) a frame operatively adapted to surround at least a portion of a person's head; (ii) a transparent face shield attached to the frame and positioned along 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 so as to provide air to a space bound by an inner surface of the transparent face shield; 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 hood or surgical gown surrounding the transparent face shield and extending over and downward from the frame, the hood or surgical gown comprising (i) at least one air inlet located within a periphery of the hood or surgical gown and aligned with the at least one air inlet of the air channel, and (ii) at least one air outlet located within a periphery of the hood or surgical gown; and (B) cutting on the fan to provide air flow along a path through the surgical outfit components in the following order: an air inlet in a surgical gown, at least one hood air inlet in a helmet, to at least one air inlet, through an air channel, out of at least one air outlet into a region of the helmet bound by a transparent face

shield, out of the helmet through at least one hood air outlet, and out of the surgical gown through at least one air outlet in the surgical gown.

Desirably, the method of reducing an amount of carbon dioxide within a surgical outfit comprises using the above-described exemplary surgical helmet 200 in combination with exemplary surgical helmet cover assembly 100 and a surgical gown. As discussed above, exemplary surgical helmet 200 in combination with exemplary surgical helmet cover assembly 100 provides controlled air flow, as well as controlled directional air flow through the surgical outfit. In other words, a sufficient volume of air and an essentially one-way direction of air flow (e.g., from hood air inlet 104 to at least one air channel inlet 203, through air channel 210, out of at least one air channel outlet 204 into a region of surgical helmet 200 bound by transparent face shield 206, along a wearer's neck line, and out of surgical helmet 200 through at least one hood air outlet 105 in a rear portion of surgical helmet 200) through the exemplary surgical helmet 200 and exemplary surgical helmet cover assembly 100 enables a significant reduction in carbon dioxide buildup within a surgical outfit. . In one desired embodiment, the method of reducing an amount of carbon dioxide within a surgical outfit, during use, results in a carbon dioxide level of less than about 5000 ppm, more desirably, less than about 4000 ppm, even 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 outfit of the present invention also improves air flow through the surgical outfit. For example, air flow through a surgical outfit without at least one hood air outlet 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 air flow through a surgical outfit of the present invention with at least one hood air outlet can be in the range of about 0.110 to about 0.156 cmm (3.9 to about 5.5 cfm), an increase in air flow of as much as 120%.

In some embodiments, the above-described methods may further comprise one or more of the following steps: sterilizing the helmet prior to use, removing the helmet from a packaging material, adjusting the helmet frame to fit snugly on the surgeon's head, checking the power supply to insure the fan is operational, combining the helmet with other pieces of protective clothing, tucking a portion of the hood of the helmet within a surgical gown, and turning on the power supply for the fan.

While the specification has been described in detail with respect to specific embodiments thereof, it will be appreciated that those skilled in the art, upon attaining an understanding of the foregoing, may readily conceive of alterations to, variations of, and equivalents to these

embodiments. Accordingly, the scope of the present invention should be assessed as that of the appended claims and any equivalents thereto.