This disclosure relates to a device for protecting medical practitioners and patients from infection by providing practitioners with a protective head covering that includes a filtered air supply. More particularly, the disclosure relates to an impermeable covering with an air supply that is filtered by drawing air through a filter using a powered blower. The filter may be sufficient to remove bacteria, viruses, smoke, vapors, and gasses from the air supplied to the practitioner.
Standard surgical helmet/hood and toga/gown systems provide AAMI level 4 protection and can isolate the individual wearing the system from bodily fluids and debris that may be splashed during the course of surgery as well as from the surgical field. Level 4 protection is sufficient to filter bacterial organisms, but not small, airborne viral particles. Thus, the system does not provide an adequate level of protection against airborne biological threats. Commercial powered or non-powered air purifying respirators with appropriate filters can provide protection but are not designed or approved for use within an operating room and are cost-prohibitive to be purchased in bulk.
Some known surgical helmet/hood systems include a fan located within the helmet itself to draw air through the hood material. Locating a fan or other air moving device above the level of the surgical field may cause air currents to flow toward the patient's open incision. These air currents may move bacteria, viruses, and other contaminants into the surgical wound and may increase the chance of infection.
In orthopedics, power instruments are used to cut bone and often debris (bone, blood, marrow, adipose, and other tissues) may be aerosolized from the surgical site. It has been customary for orthopedic surgeons to wear a helmet and toga system. This system consists of a disposable sterile hood placed over the helmet to provide a sterile barrier between the patient's wound and the surgeon. The air that goes into the helmet is drawn through the top of the paper hood. Thus, the paper forming the hood itself acts as a filter. This paper filter may be equivalent to a regular operating room mask that can remove droplets from the air drawn into the hood. The sterile barrier protects the surgical team from these airborne threats. Further, the patient is protected from the surgical team from any bacteria that may be shed by the team as the system provides a fully enclosed barrier between the patient and team member.
While these helmet systems may be an effective system for maintaining sterility of the wound, the paper material that filters air delivered to the surgeon not nearly as protective as filter elements specifically designed to remove very small particles such as an N95 filter or a P100 filter. As a result, these known helmet and toga systems do not protect the surgeon or other operating room personnel from virus or smoke. In the case of orthopedic surgery, electrocautery smoke (sometimes referred to as “Bovie” smoke) is generated when tissues are cauterized and when laser cutting instruments are used. This smoke may be carcinogenic or otherwise harmful to operating room personnel.
With the advent of COVID-19 it was recognized that known helmet/toga systems had the capability to filter bacteria but not viral particles. Moreover, known helmet and toga systems may increase the risk to the individual wearing the system because such systems have the potential to concentrate viral particles within the hood disposed about the face and mucous membranes of the surgeon. In some cases, manufacturers of surgical hoods encourage users to wear tight-fitting goggles under the hood to protect the mucous membranes of the eye from viral exposure.
Best practices for viral protection now encouraged the use of surgical helmet and hood systems with an N-95 or other mask worn directly on the face for personal protection worn inside of the hood. This arrangement creates several issues. The wearer's eyes are not protected from airborne virus particles. The facemask may be uncomfortable, may make the wearer's breathing more difficult, and may impair the wearer from effectively exchanging CO2. Facemasks may also impair heat exchange via the oral cavity, causing the wearer to feel hot. Facemasks may also obstruct the wearer's field of vision. Facemasks masks may also prevent surgeons from wearing specialized glasses with built in magnification (“loupes”) or glasses that block radiation (“x-ray glasses”) as they may preclude proper fit of these devices on the bridge of the nose.
In addition, facemasks, like the N95 mask, only work properly if there is a good seal against the wearer's face. Maintaining such a seal may be particularly difficult during orthopedic surgery, which may require the surgeon and other personnel to make significant physical movements to manipulate a patient's limbs, to operate saws for cutting bone, to impact metal broaches to shape bone canals, and the like. This physical activity raises a significant potential for the surgical mask to shift, violating its seal. Where the facemask is worn under a helmet and toga system, the wearer cannot easily reseal the facemask.
The length of some orthopedic procedures, such as total joint replacement procedures, also makes comfort of personal protective equipment (PPE) particularly important. Surgeries may be physically demanding and may last a number of hours. Highly effective facemasks, like N95 and P100 masks may not provide sufficient comfort, ease of breathing, and security of seal for these procedures. Even a well-fitted mask may be uncomfortable for long periods of time.
Cost has been a major determinant of the availability of PPE. Often protective equipment like helmet and toga systems must be shared among hospital personnel. At facilities where numerous operating rooms are in use simultaneously, a single helmet may be exchanged many times per day. Decontamination of the helmets between uses may not be practical. The high cost of known helmet and toga systems may prevent some facilities from having an adequate number on hand to accommodate demand and may not allow some systems to be taken out of use to be sterilized.
The present disclosure relates to a surgical helmet that addresses these and other difficulties.
According to one aspect of the disclosure, there is provided a surgical helmet that provides a stream of filtered air that is free of, or has a reduced amount of, viruses and bacteria compared with ambient air. This stream of filtered air is generated without requiring effort by the wearer to draw ambient air through the filter element. Such a helmet does not impair the wearer's breathing, does not require a facemask that is sealed against the wearer's face, and does not obstruct the wearer's field of vision.
According to another aspect of the disclosure, there is provided a personal protective system that protects a wearer from bacteria, viruses, vapors, and gasses and does not require a facemask to be sealed against the wearer's face.
According to another aspect of the disclosure, there is provided a surgical helmet that is relatively simple to manufacture and can be produced at a lower cost than known helmet and toga systems.
According to another aspect of the disclosure, there is provided a surgical helmet that can remove gases and vapors, including smoke generated during surgical procedures and provide a stream of air to the wearer that is substantially free of these contaminants.
According to another aspect of the disclosure, there is provided a surgical helmet and personal protective system that protects a wearer from airborne contaminants and does not require the user to wear a close-fitting facemask or goggles to protect mucous membranes.
According to another aspect of the disclosure, there is provided a surgical helmet and personal protective system that includes a device to drive air through a filter element where the air moving device is located below the surgical field and/or at the wearer's back to avoid generating air currents that might carry contaminants into the surgical field. According to another aspect, the device to drive air through the filter element is fixed to the helmet to be worn on the wearer's head and is provided with a filter element that extends upward from the helmet.
According to another aspect of the disclosure, there is provided a surgical helmet and personal protective system that facilitates air flowing past the face of the wearer to flow out from the bottom of the wearer's garment or out from the back of the garment so that the outflow of air is below the level of a surgical field or in a direction away from the surgical field. A system according to embodiments of the present disclosure provides protection to medical personnel when operating in an environment with potential airborne viral and bacterial contaminants and harmful gasses. According to some aspects, such a system works with existing commercial surgical hoods and toga personal protection systems and enhances their capability to supply filtered air. According to some other aspects of the disclosure, there is provided a personal protective system to protect personnel from bacteria, viruses, smoke, vapors, or gasses suitable for use by hospital staff, clinicians, first responders, and lay persons that may be exposed to such contaminants.
According to another aspect of the disclosure, there is provided a surgical helmet and hood system where the hood is readily detachable from a powered air filtration system and wherein the hood incorporates passages to direct air flow to selected parts of the wearer's head and face. According to a further aspect, the hood and air-directing passages are formed from relatively inexpensive materials so that the hood may be disposed of and replaced after a single use, or after a limited number of uses. According to a still further aspect, the air-directing passages are formed integrally with the hood by one or more strips of material joined with an interior surface of the hood to form a duct.
According to some embodiments, the system includes modular components that can be readily adapted to work with commercially available helmets or with a customized helmet according to the disclosure. Helmets according to the disclosure may incorporate components such as head-lamps, digital video cameras, microphones, speakers, heads-up display projectors, head mounted displays, virtual or augmented reality displays, and the like based on application specific needs.
A more complete appreciation of the disclosure and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:
The hood 100 may be coupled with a surgical gown or toga 102. According to some embodiments, the hood 100 and toga 102 are hermetically connected with one another to form a continuous impermeable barrier around the wearer's body from the top of the hood, down to the lower hem of the toga 102. According to other embodiments a lower portion of hood 100 is fitted inside the upper portion of toga 102 so that air flowing out of hood 100 flows downward into the space between the wearer and the toga 102 and flows out from below the lower hem of toga 102.
According to alternative embodiments, hood 100 is designed to be worn without a gown or toga. Hood 100 may include a restrictive hem to provide a closed or partially closed fitting round the torso, shoulders, or neck of the wearer. The restrictive hem may be formed by an elastic band, and/or a drawstring to adjust to the size of the wearer's body. Such an embodiment might be used outside of an operating room, for example, by a first responder, where protection of a patient from contamination by the wearer is less critical than during a surgical procedure.
As shown in
According to some embodiments, frame 13 includes a chin guard or bar that forms a scaffold 12 to hold the front part of hood 100 and visor 104 (
Duct 14 is provided across the top of frame 13. According to one embodiment, duct 14 extends from the back of the helmet, over the top of the helmet, and ends above the wearer's forehead. Air outlet 14a is provided at the end of duct 14. According to some embodiments, outlet 14a includes features such a louvers that direct air flowing from duct 14 in specific directions, for example, along an inside surface of visor 14 to reduce condensation from accumulating on the visor and/or across the wearer's face. According to other embodiments, outlet 14a includes positionable louvers or secondary ducts that allow the wearer to customize the direction of air flow. This may include one or more ducts to direct airflow along the sides of the wearer's head and/or louvers to provide multiple streams of air across portions of the wearer's face. Duct 14 may also include features that allow the length and direction of the duct to be adjusted to accommodate the size of the wearer's head and the direction of the airflow by, for example, providing a section of flexible “accordion pleats” along the length of the duct.
At the opposite end of duct 14 is air inlet 14b. Inlet 14b is connected with the one or more tubes 30 by fitting 16. In this embodiment two tubes 30 are provided and fitting 16 is a manifold that directs the flow of air from both tubes into duct 14. Tubes 30 may be made from flexible elastomeric tubing to allow helmet 10 to move easily with respect to the rest of the system. According to a preferred embodiment tubes 30 are formed from corrugated ventilator tubing. Fitting 16 provides a hermetic seal between tubes 30 and duct 14. According to one embodiment, instead of a fitting connecting two hoses 30 to inlet 14b. a plurality of inlets 14b in fluid communication with duct 14 are provided with hoses 30 each connected to a respective inlet 14b.
Blower unit 20 is connected to the lower end of tube 30 by fitting 22, which can be seen for example in
One or more filter elements 29a. 29b. 29c are selected to remove contaminants from air drawn into blower unit 20 and delivered to helmet 10 via tubes 30. According to some embodiments, the filter elements may be commercially available N95 or P100 filters that remove very small particles from the air, including virus particles and smoke particles. The one or more filter elements 29a-29c may also include substances that adsorb contaminants using activated charcoal. Depending on the types of contaminants expected during use, filters may also include substances that remove radiological contaminants, that reduce or eliminate odors, or that adsorb carbon dioxide or other gasses. According to other embodiments, filters 29a-29c comprise high efficiency particulate air filters, activated carbon filters, electrostatic filters, and/or ultraviolet air purifiers. Filters may also be customized to filter specific types of contaminants. Because air is drawn through the filter elements by a powered blower, no increased effort is required from the wearer to draw air through the filters 29a-29c.
In addition to reducing contaminants such as bacteria and viruses from the air supplied to the wearer, an antimicrobial coating may be applied to interior surfaces of the blower housing 24, tubes 30, manifolds 16, 22 and/or duct 14. Certain metals and metal alloys including copper and copper alloys are known to neutralize organisms on contact. According to some embodiments, interior surfaces of system 1 include such antimicrobial coating to further reduce the exposure of the wearer to harmful contaminants.
Control input 218 provides an interface that allows the user to control the blower unit 20. Control input 218 may include a switch to turn the blower on and off and a knob or other input to allow a user to adjust the speed of the blower to customize the velocity of air flow to the preference of the user. According to some embodiments, control input 218 also includes an interface to apprise the user of operating parameters of the blower unit 20, such as the time since new filters 29a-c have been installed, the service lifetime of the blower motor 200, and the level of battery charge or expected time until battery recharging is necessary. Control input 218 provides a signal to blower controller 219 to turn on and off blower motor 200 and to adjust the speed of the motor. According to some embodiments, the speed of blower motor 200 is controlled by modulating a current or voltage applied across windings of the motor. According to other embodiments, controller 219 provides a pulse width modulation (PWM) signal applied to a blower controller internal to the blower housing that varies the current or voltage applied across the motor windings.
Sensor package 226 includes air input sensor 226a positioned between filters 29a. 29b. 29c and the blower 200 and air output sensor 226b positioned downstream from the blower as shown in
Flow evaluation logic circuit 228 determines operating characteristics of the system based on signals from the sensor package 226 and detects when an error condition exists. When an error condition is detected, flow evaluation logic circuit 228 sends a signal to alarm 230 to alert the user of the error condition.
Pressure measured at the inflow of the blower 20 by input pressure sensor 226a depends on the ambient atmospheric pressure and on the pressure drop of air pulled through filters 29a-c. This in turn depends on the volume of air drawn through the filters and on the resistance to flow provided by the filters. As the filters 29a-29c accumulate materials that are filtered from the air stream, the resistance may increase as the free surfaces of the filters are covered. According to some embodiments, the input pressure at input pressure sensor 226a is compared with an acceptable range of pressure that indicates a sufficiently low resistance created by the filters. As the filters reach the end of their useful life, the pressure at input pressure sensor 226a may drop below an acceptable threshold and an error signal indicating that the filters need to be replace may be provided to the user via alarm 230. This threshold may be adjusted depending on the speed of the blower motor 200.
Air pressure measure at the outflow of the blower 20 by output sensor 226b may depend on the back pressure created as air flows through tubes 30, duct 14, and out through openings in hood 100 and toga 102. A drop in output pressure may indicate that a leak has developed between the blower unit 20 and the inside of the hood 10 and toga 102, for example, because a hose 30 has become disconnected. Such a drop in output pressure may be detected as a leak error condition and flow evaluation logic circuit 228 may alert the user of the leak via alarm 230.
According to one embodiment, evaluation circuit 228 determines a differential pressure between the air flow upstream from sensor 226a and downstream of the blower 20 from sensor 226b. Based on known aerodynamic parameters for the blower unit 20, the air flow through the blower may be determined by differential pressure between sensors 226a and 226b. When the differential pressure is within acceptable tolerances, and hence, when airflow is within acceptable limits, no error condition exists. According to some embodiments the differential pressure measurement allows detection of various conditions that might affect the performance of the system. These include i) a filter leak condition where incoming air bypasses the filter element; ii) a conduit leak condition where filtered air leaks out from tubes 30 and/or duct 14 before being delivered to the wearer; iii) a filter blockage condition where the flow of incoming air through the filters 29a-c is blocked or diminished as filter is nearing the end of its useful lifetime; and iv) a conduit blocked condition where air flowing through tubes 30 and/or duct 14 is blocked, for example, by a kink in one or more of the hoses 30. According to some embodiments, conditions i) and ii) are detected by determining that flow through the blower unit 20 is in excess of what is expected during normal operation and conditions iii) and iv) are detected by determining that flow through the blower unit 20 is less than what is expected during normal operation.
According to some embodiments, flow evaluation circuit 228 and sensor package 226 are adapted to determine whether the flow of air being delivered to the wearer is above a minimum threshold, for example, 170 liters per minute. According to this embodiment, if the air flow falls below the minimum threshold, a signal is communicated by the wearer via alarm 230 to alert the wearer.
Power management circuit 216 may also provide electrical power to accessory power circuit 222. Accessory power circuit 22 is connected, via wire 225 shown in
The proximal end of duct 110 is connected with blower 20. According to some embodiments, blower 20 is as described with respect to previous embodiments. A connector 116 is provided to releasably connect the output from blower 20 into the lumen of duct 110. Connector 116 may be a screw connector, a snap-connector, a quick-connect coupling, an interference fit connector between the duct and the blower, or other connector mechanisms known in the field of the invention.
Hood 110 may be formed from a variety of materials including, but not limited to cotton, polyester, polyethylene, nylon, polypropylene, or other fabric. In addition, the material forming hood 110 may be a composite material or blend or laminated of two or more layers of material and may combine porous and non-porous layers. According to one embodiment, hood 110 provides a waterproof barrier that allows transpiration of water vapor to provide breathability. According to one embodiment, the material forming hood 110 conforms to breathability standards established by the FDA, for example, the F2407 guidelines set by the American Society for Testing and Materials (ASTM).
Hood 110, according to this embodiment, may be formed from impermeable material, for example, a polymer film. Such a material would prevent any exchange of gasses through the hood to provide protection in environment where highly toxic gasses or highly bio-hazardous organisms may be present. Hood 100 may be formed from semipermeable material, that allows the exchange of some gasses, for example, water vapor, to enhance the comfort of the wearer by reducing humidity within the hood. Such materials may be suitable where protection from microorganisms is required, for example, an operating theater. Hood 100 may also be formed from relatively permeable material, for example, a woven fabric.
According to one embodiment, hood 100 is formed from a relatively inexpensive material, such as paper coated with a polymer coating to provide a selected permeability and other characteristics that will be discussed below. Likewise, duct 110 and visor 104 are formed from relatively inexpensive components so that the assembly of hood 100, duct 110 and visor 104 form a disposable component.
One or more holes or openings 114a are formed through material strip 113 at the distal end of duct 110. Openings 114a are positioned to direct air flowing through duct 110 toward the face of the wearer, toward the inside surface of visor 104, or to both the visor 104 and the wearer's face. The output of blower 20 and the sizes and numbers of openings 114a are selected so that a sufficient backpressure is maintained inside lumen 111 to hold duct 110 open.
According to one embodiment, wire 225 from the blower unit 20, as shown in
The disclosure is not limited to the arrangement of strip 113 and the corresponding shape of duct 110 shown in the figures. Strip 113 may be shaped and bonded with hood 100 to direct airflow to various locations inside hood 100. For example, duct 110 could be formed with one or more branches extending toward the sides of the wearer's head to direct airflow to the sides of the wearer's face.
While illustrative embodiments of the disclosure have been described and illustrated above, it should be understood that these are exemplary of the disclosure and are not to be considered as limiting. Additions, deletions, substitutions, and other modifications can be made without departing from the spirit or scope of the disclosure. Accordingly, the disclosure is not to be considered as limited by the foregoing description.
The present application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 63/081,051, filed on Sep. 21, 2020, which is incorporated herein by reference.
Number | Date | Country | |
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63081051 | Sep 2020 | US |