NZ744301B2 - Donnable barrier devices, systems, and methods with touchless control - Google Patents

Donnable barrier devices, systems, and methods with touchless control Download PDF

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Publication number
NZ744301B2
NZ744301B2 NZ744301A NZ74430117A NZ744301B2 NZ 744301 B2 NZ744301 B2 NZ 744301B2 NZ 744301 A NZ744301 A NZ 744301A NZ 74430117 A NZ74430117 A NZ 74430117A NZ 744301 B2 NZ744301 B2 NZ 744301B2
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New Zealand
Prior art keywords
controller
sensor
output signals
fan
signals
Prior art date
Application number
NZ744301A
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NZ744301A (en
Inventor
David Lee Cargille
Paul Gruber
Richard Nickl
Giorgio Rosati
Original Assignee
Thi Total Healthcare Innovation Gmbh
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Application filed by Thi Total Healthcare Innovation Gmbh filed Critical Thi Total Healthcare Innovation Gmbh
Priority claimed from PCT/US2017/012654 external-priority patent/WO2017120562A2/en
Publication of NZ744301A publication Critical patent/NZ744301A/en
Publication of NZ744301B2 publication Critical patent/NZ744301B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A41WEARING APPAREL
    • A41DOUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D1/00Garments
    • A41D1/002Garments adapted to accommodate electronic equipment
    • AHUMAN NECESSITIES
    • A41WEARING APPAREL
    • A41DOUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/002Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches with controlled internal environment
    • A41D13/0025Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches with controlled internal environment by means of forced air circulation
    • AHUMAN NECESSITIES
    • A41WEARING APPAREL
    • A41DOUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • A41D13/1107Protective face masks, e.g. for surgical use, or for use in foul atmospheres characterised by their shape
    • A41D13/1153Protective face masks, e.g. for surgical use, or for use in foul atmospheres characterised by their shape with a hood
    • AHUMAN NECESSITIES
    • A41WEARING APPAREL
    • A41DOUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • A41D13/1161Means for fastening to the user's head
    • AHUMAN NECESSITIES
    • A41WEARING APPAREL
    • A41DOUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • A41D13/1184Protective face masks, e.g. for surgical use, or for use in foul atmospheres with protection for the eyes, e.g. using shield or visor
    • AHUMAN NECESSITIES
    • A42HEADWEAR
    • A42BHATS; HEAD COVERINGS
    • A42B3/00Helmets; Helmet covers ; Other protective head coverings
    • A42B3/04Parts, details or accessories of helmets
    • A42B3/0406Accessories for helmets
    • A42B3/0433Detecting, signalling or lighting devices
    • A42B3/046Means for detecting hazards or accidents
    • AHUMAN NECESSITIES
    • A42HEADWEAR
    • A42BHATS; HEAD COVERINGS
    • A42B3/00Helmets; Helmet covers ; Other protective head coverings
    • A42B3/04Parts, details or accessories of helmets
    • A42B3/28Ventilating arrangements
    • A42B3/286Ventilating arrangements with forced flow, e.g. by a fan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/05Splash shields for protection of the surgeon, e.g. splash guards connected to the apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057Pumps therefor
    • A61M16/0066Blowers or centrifugal pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06Respiratory or anaesthetic masks
    • A61M16/0605Means for improving the adaptation of the mask to the patient
    • A61M16/0627Means for improving the adaptation of the mask to the patient with sealing means on a part of the body other than the face, e.g. helmets, hoods or domes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/14Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16Devices to humidify the respiration air
    • A61M16/161Devices to humidify the respiration air with means for measuring the humidity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/80General characteristics of the apparatus voice-operated command
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/40Respiratory characteristics
    • A61M2230/43Composition of exhalation
    • A61M2230/432Composition of exhalation partial CO2 pressure (P-CO2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/63Motion, e.g. physical activity
    • AHUMAN NECESSITIES
    • A62LIFE-SAVING; FIRE-FIGHTING
    • A62BDEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B17/00Protective clothing affording protection against heat or harmful chemical agents or for use at high altitudes
    • A62B17/04Hoods
    • AHUMAN NECESSITIES
    • A62LIFE-SAVING; FIRE-FIGHTING
    • A62BDEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/003Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort having means for creating a fresh air curtain
    • AHUMAN NECESSITIES
    • A62LIFE-SAVING; FIRE-FIGHTING
    • A62BDEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/04Gas helmets
    • A62B18/045Gas helmets with fans for delivering air for breathing mounted in or on the helmet
    • AHUMAN NECESSITIES
    • A62LIFE-SAVING; FIRE-FIGHTING
    • A62BDEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/08Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices
    • AHUMAN NECESSITIES
    • A62LIFE-SAVING; FIRE-FIGHTING
    • A62BDEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B7/00Respiratory apparatus
    • AHUMAN NECESSITIES
    • A62LIFE-SAVING; FIRE-FIGHTING
    • A62BDEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B9/00Component parts for respiratory or breathing apparatus
    • A62B9/006Indicators or warning devices, e.g. of low pressure, contamination

Abstract

barrier system, device, and method protects medical professionals and patients from exposure to contaminants and bodily fluids. The system includes a head unit (e.g., 708) shaped to be worn over the head of the wearer; a hood (e.g., 704) positioned over the head unit; one or more sensors (e.g., 1902) configured to produce one or more sensor-output signals; and a controller (e.g., 1904) connected to the one or more sensors and configured to produce one or more controller-output signals based on the one or more sensor-output signals. Further, a device inside a barrier system is controlled by (a) sensing one or more characteristics; (b) producing one or more sensor signals based on the sensed one or more characteristics; (c) converting and/or processing the one or more sensor signals to produce one or more controller-output signals; and (d) controlling the device based on the one or more controller-output signals. 02) configured to produce one or more sensor-output signals; and a controller (e.g., 1904) connected to the one or more sensors and configured to produce one or more controller-output signals based on the one or more sensor-output signals. Further, a device inside a barrier system is controlled by (a) sensing one or more characteristics; (b) producing one or more sensor signals based on the sensed one or more characteristics; (c) converting and/or processing the one or more sensor signals to produce one or more controller-output signals; and (d) controlling the device based on the one or more controller-output signals.

Description

DONNABLE BARRIER SYSTEMS, DEVICES, AND METHODS WITH TOUCHLESS CONTROL D APPLICATIONS This application claims the benefit of US Provisional Patent Application No. 62/275,995 filed January 7, 2016, the content of which is hereby incorporated by reference in its entirety.
FIELD OF THE INVENTION Embodiments of the invention relate generally to r devices, filtration devices, and personal protection systems for use in hazardous environments, including medical, surgical, and field environments. Certain embodiments protect medical professionals from exposure to ne contaminants and bodily fluids and also protect patients, medical professionals, and observers from cross-contamination during surgical procedures. n embodiments relate more particularly to helmets, hoods, masks, face s, togas, or other wearable apparatuses for protecting a healthcare professional, patient, or observer from exposure to biohazardous materials during surgery, other medical procedures, emergency medicine, treatment of s in the field, and the like.
BACKGROUND OF THE INVENTION r devices and personal protection systems are used in medical and surgical ures to provide a sterile barrier n the surgical personnel and the patient. During such procedures (and especially during orthopedic operations), a drill or d saw often tes spray, splash, and aerosol from a patient’s surgical wound to the surgeon. This exposes the surgeon to a risk of infection.
Traditional surgical masks and cups are not capable of completely keeping the sterility of the surgical wound. In some cases, bodily materials from a surgical team (e.g., sweat, hair, dandruff, or even saliva) may infect the patient. Forthese s, especially in orthopedic surgery, a surgical helmet has been used for many years. A conventional surgical helmet may include a battery-powered fan for air circulation and a e hood that covers the helmet and has a transparent visor, lens, or other vision element.
TH|101WOP One such system is disclosed in US. Patent No. 5,054,480, the contents of which are orated herein by reference ses that basic structure of such a system. Specifically, the traditional system includes a helmet that ts a toga, also known as a drape or hood. (The terms "toga", "drape", and "hood" are used interchangeably herein and are intended to have the same meaning.) This lage is worn by medical personnel who want to establish the sterile barrier.
The hood includes a transparent face shield. The helmet includes a ventilation unit that includes a fan. The ation unit draws airthrough the hood so the air is circulated around the wearer. This reduces both the amount of heat that is trapped within the toga/hood and the carbon dioxide (C02) that builds up in this space. It is further known to mount a light to the helmet. The light, which is directed through face shield illuminates the surgical site.
Donning a hood creates a closed chamber around the operator’s head, which represents both a heating element (by means of radiation and/or convection) and a source of hot and humid respiratory air with significant C02 concentrations up to 40,000 ppm. Without air exchange between the chamber and the ambient environment, a so called "sauna effect" is created, leading to temperatures of up to 32°C, humidity levels of up to 85% (relative humidity) and C02 concentrations of up to 40,000 ppm inside the chamber. To avoid this , state of the art surgical protection systems e hoods with a filter element, which supports air exchange and provides breathability as well. This is lly accomplished using fans that move air into the chamber and circulate air within the chamber.
Other personal protection systems are disclosed in US. Patent No. 6,481,019 to Diaz et al., in US. Patent No. 9,173,437 to VanDerVVoude et al., and in US. Patent Application No. 13/984,908 filed by Giorgio Rosati et al., the contents of each of which is incorporated by nce in its entirety. VanDerVVoude et al., for example, describes a system having a hood, a fan, a light, and a helmet with control switches that a user actuates by hand.
PROBLEMS TO BE SOLVED The present inventors have recognized and fied a number of drawbacks of conventional filtration l systems for health care professionals.
Some systems establish a bypass between the operator’s head r and the intake air funnel of the main fan, which allows waste air from inside the TH|101WOP operators head chamber to be drawn back into the chamber, thereby reducing the fresh air exchange rate, especially with filters having low breathability (i.e., high bacterial filtration efficiency). A significant portion of air delivered by the main intake fan is therefore waste air instead of fresh ambient air. This effect increases with decreasing breathability of filter materials. r drawback relates to difficulty in donning. After putting on the helmet, ing it, and connecting the power line of the helmet to the battery pack, a user of a conventional hood dons the device in three steps, by: (1) unfolding the hood, (2) attaching the vision t to the helmet, and (3) pulling the fabric over the helmet.
Known donning concepts require assistance by at minimum one sterile or non-sterile supporting individual in the operating theatre to avoid breaching sterility (of all outer surfaces of the gown) during g. Conventional hoods use fixed- position vision element frames on the helmet. During attachment of the hood ortoga to the front of the face, visibility is greatly reduced because of the opaque nature of the fabric. This its the user from performing the next step—pulling the fabric over the helmet—by himself or herself, since the hood of contacting the e of the fabric with a non-sterile body part is too high. Therefore, a sterile-dressed supporting individual is required to perform fabric-pulling step (3). Alternatively, a non-sterile dressed ting individual might also perform step (3), with the limitation to touch only the inside of the fabric or only portions of the fabric that are subsequently covered by sterile surgical gowns.
Another drawback relates to difficulty in fan-speed control. Required air exchange rates depend, among otherfactors, on ambient air temperature and humidity, physical activity during a surgical ure, specific heat output of the human body, and mental stress level, as well as personal preferences for air conditions and air quality. Some conventional surgical protection systems offer user- adjustability of fan speeds to se or reduce the air input. A higher or lower air input causes a higher or lower air circulation that may e the comfort of the surgeon. The quantity of air circulation needed may vary according to personal preferences of the surgeon or his or her physical activity during the different phases of an ion, which may be lighter or heavier at various moments.
Conventional surgical helmets regulate the fan speed by a button or switch placed somewhere on the helmet. To adjust fan speed, a n must press a TH|101WOP mechanical button or activate a touch switch located below the sterile barrier (hood or toga) and therefore must touch the barrier. This is neither safe nor convenient.
During operation, the helmet is often covered by a sterile drape, and the surgeon must wear surgical gloves. Activating the switch is often difficult and inconvenient, because the surgeon can neither see nor easily feel where the switch is. It is unsafe, because the button or switch might become contaminated in n circumstances, e.g., by unnoticed contact with a lamp, a colleague, or an ile part. By touching the switch, which is no longer sterile, the surgeon may contaminate his hands, other , and other surfaces.
SUMMARY OF THE INVENTION Embodiments of the disclosure solve these problems and provide other benefits through a personal protection system and device employing one or more of the following features: an intake air duct with enhanced fresh air ation; an easy-donning hood-helmet interface; a free-flow main air duct; automatic airflow control; and a touchless user interface.
In one embodiment, the invention is a barrier system. The system ses a head unit (e.g., 708) shaped to be worn over the head of the ; a hood (e.g., 704) positioned overthe head unit and forming a r (e.g., 212); one or more sensors (e.g., 1902) located within the r and configured to produce one or more sensor-output signals; and a controller (e.g., 1904) connected to the one or more sensors and configured to e one or more controller-output signals based on the one or more sensor-output signals.
In another embodiment, the invention is a method of controlling a device inside a barrier system comprising a head unit (e.g., 708), a hood (e.g., 704), one or more sensors (e.g., 1902), and a controller (e.g., 1904). The method ses: (a) sensing one or more characteristics; (b) producing one or more sensor signals based on the sensed one or more characteristics; (c) converting and/or processing the one or more sensor signals to produce one or more controller-output signals; and (d) controlling the device based on the one or more controller-output s.
In another ment, the invention is a barrier device. The barrier device comprises: a head unit (e.g., 708) shaped to be worn over the head of the wearer; a hood (e.g., 704) positioned over the head unit and forming a chamber (e.g., 212); one or more sensors (e.g., 1902) located within the chamber and configured to TH|101WOP produce one or more sensor-output signals; and a controller (e.g., 1904) connected to the one or more sensors and configured to produce one or more controller-output signals based on the one or more sensor-output signals.
In another embodiment, the invention is an apparatus for controlling a device inside a barrier system comprising a head unit (e.g., 708), a hood (e.g., 704), one or more sensors (e.g., 1902), and a controller (e.g., 1904). The apparatus ses: (a) means for sensing one or more characteristics; (b) means for producing one or more sensor signals based on the sensed one or more characteristics; (c) means for converting and/or processing the one or more sensor s to produce one or more controller-output s; and (d) means for controlling the device based on the one or more controller-output signals BRIEF DESCRIPTION OF THE DRAWINGS Other advantages of the present invention will be readily appreciated and better understood by reference to the following detailed description, when considered in tion with the accompanying drawings wherein: is a ctive view of an exemplary surgical helmet in an ment of the disclosure. is a top view of the surgical helmet shown in is a cross-sectional view of a first exemplary head unit having a top- mounted fan in an embodiment of the disclosure. is a cross-sectional, scaled view of a portion of the head unit shown in Fle. 5 and 6 show a second exemplary head unit having a bottom-mounted fan in an embodiment of the disclosure.
Fle. 7-15 show an ary easy-donning hood-helmet interface in an embodiment of the disclosure. is a perspective view of an exemplary surgical helmet having two lights in an embodiment of the disclosure.
Fle. 17 and 18 show an exemplary air duct in an exemplary head unit in an embodiment of the disclosure. shows a block diagram of an exemplary touchless l system in an embodiment of the disclosure.
TH|101WOP FIGs. 20-22 show exemplary touchless-control sequences and movements. shows a graph of an exemplary djustable fan speed based on ature.
DETAILED DESCRIPTION OF THE INVENTION Embodiments of the disclosure solve these problems and provide other benefits by employing one or more of the following features: an intake air duct with enhanced fresh air circulation; an easy-donning hood-helmet interface; a free-flow main air duct; automatic airflow control; and a touchless user interface.
With reference to an ary surgical helmet 100 in an embodiment of the invention comprises: a head unit 102, a lensframe 104 mounted on the head unit 102, and an adjustable head strap 106 for securing head unit 102 on a user's head.
With reference to the head unit 102 ses a fan intake duct 202 (forming zone 1) configured to guide intake airflow 204, a mounting plate 206, an intake fan 208 mounted on the underside of mounting plate 206, a fan outlet 210 directed into a main air duct 212 located within a portion of head unit 102, and a sealing edge 214.
Intake Air Duct with Enhanced Fresh Air Circulation Embodiments of the disclosure may include an intake air duct that is adapted to e enhanced fresh air circulation. FIGs. 2 and 3 show an ary intake air duct 202 in one embodiment of the disclosure.
With reference to head unit 102 comprises the intake air duct 202 in combination with intake fan 208 and a filter material 302 (e.g., formed by the fabric of a hood) that creates a plenum 308 (Zone 1), which is shown in During operation, fresh ambient air 304 is sucked by the fan 208 through the filter 302 into the plenum 308 (zone 1) (and further through the fan 208 into the operator's head chamber 306. The fan intake duct 202 is sealed off against the filter al 302 and the fan 208, creating a local area of low pressure, y forcing the air to be drawn in only h the filter material 302. This arrangement ensures that no bypass between the operator's head chamber 306 and the fan intake duct 202 is created.
THl101WOP The sealing between the fan intake duct 202 and the filter material 302 is promoted by hydrodynamic forces because of local low pressure in the intake air duct 202 (zone 1). This effect helps to create a seal, even in the event that the filter material 302 is placed loosely on the fan intake duct 202, without additional on means, as shown in The sealing edge 214 seals reliably, because it is dimensioned such that the filter is concave (angle x° > 0 relative to the general plane of the sealing edge 214) because of negative pressure.
The sealing edge 214 further seals reliably through protrusion of the filter material 302 overthe surrounding surfaces. Additionally, a reliable seal between the fan 208 and the fan intake duct 202 is provided.
Fle. 5 and 6 show another exemplary intake air duct 502 in another embodiment of the disclosure. Like the embodiment shown in a fan assembly 500 comprises an intake air duct 504 having a g edge 502, and a fan 506 having a fan intake 508 and a fan outlet 510. Fan assembly 500, however, is configured so that the fan is recessed below the upper surface of intake air duct 506, and it is bottom-mounted within the fan outlet 510, ratherthan top-mounted on ed mounting plate 206. In contrast, the embodiment shown in does not need an ed mounting plate.
The present inventors have ined through experimentation that, in one embodiment, the negative pressure created by fan 208 is within a predetermined ve-pressure range having a lower-boundary vacuum pressure and an upper- boundary vacuum pressure. The lower-boundary vacuum pressure is the pressure at which the filter al 302 is pulled down so far that it interferes with the intake airflow 202. At the lower-boundary vacuum pressure, the filter material reduces the intake airflow so much that the airflow is insufficient for te ventilation, which renders the helmet unuseable. The upper-boundary vacuum pressure is the pressure at which the filter material 302 fails to provide an adequate seal at sealing edge 214. The upper- and lower-boundary vacuum pressures depend upon the teristics of the filter material 302.
The present inventors further ined through experimentation that the intake airflow is a ear function having an inflection point at an optimal vacuum pressure that varies depending on the type of filter material. Assuming that a fan starts operation at an initial ambient pressure, the ude of the negative TH|101WOP pressure initially increases as the fan speed increases. As the negative pressure increases, the intake airflow correspondingly increases as a positive function of the negative pressure, and ally reaches a maximum amount of airflow at the optimal vacuum pressure.
Surprisingly, the present inventors discovered that if the ve pressure continues to increase past the optimal pressure, then the airflow begins to decrease, rather than to increase as one would ordinarily expect. When the magnitude of the negative re is larger than the optimal vacuum pressure, the intake airflow is therefore a negative function of the negative re. These results were counterintuitive and unexpected.
The inventors also found that, even for a given fan, the way in which the fan is mounted and the shape of the intake air duct 202 may result in more airflow or less airflow, depending on the magnitude of the ve pressure exerted upon the filter material 302 and on the optimal vacuum pressure for a given filter material. They further found that, when certain fans are top-mounted within head unit 102 as shown in they exert a smaller vacuum pressure, s when those fans are bottom-mounted (as shown in bed below), they exert a r vacuum pressure. The inventors further discovered that, in certain circumstances, the vacuum pressure created by such fans may exceed the optimal vacuum pressure (Le, a pressure that is past the inflection point), such that ng the vacuum pressure by top-mounting the fan yields a greater airflow, rather than a r The inventors accordingly have discovered and identified a problem in which certain bottom-mounted fans yielded inadequate ventilation, and solved the problem by providing the elevated mounting plate shown in which allows a fan to be top-mounted, and thereby reduces the vacuum pressure and increases the airflow. r, when such fans are top-mounted instead of bottom-mounted, the fan size may be reduced because of the greater airflow, thereby achieving an unexpected increase in ency and a cost savings that makes the helmet more competitive in the marketplace.
Easy-Donning Hood-Helmet ace Embodiments of the disclosure may include an easy-donning hood-helmet interface. FIGs. 7-16 show an exemplary easy-donning hood-helmet interface, in TH|101WOP one embodiment of the disclosure. In this embodiment, a vision element frame 706 (hereinafter ed to as |ensframe 706) is adapted to swivel around pivot points or along a slotted link on head unit 708, thereby allowing the user full visibility during donning, which reduces the likelihood of ntional contact with the gown. Color- coded ribbons 702 (colored grey (702b) and white (702a), in this example) allow the user to pull the hood 704 over his or her own head, maintaining a safe distance to the outer surface of the hood 704 itself.
The following steps are performed in an exemplary donning sequence consistent with one embodiment of the disclosure: As shows, Step 1 involves unpacking and unfolding the outer tion garment of the hood 704. The hood 704 is folded inside-out to reduce risk of contamination. Color-coded ribbons 702a, 702b indicate where to grab the hood 704 to complete donning. These ribbons will rest eath the surgical gown after donning.
Turning now to Step 2 involves attaching the folded hood 704 on the |ensframe 706, in an open position. Geometrical guidance is ed by a centering hook (shown in ), located at the lower center of the |ensframe 706 (where it is easily visible the |ensframe is folded into an open position) as well as several hookand-loop fasteners or magnets along the |ensframe 706.
FIGs. 9 h 11 show the substeps 3a, 3b, and 3c of Step 3, which es pulling the hood front 704a (shown shaded in grey) and back 704b (shown colored white) over the helmet 710 (formed by |ensframe 706 and head unit 708) and the user’s head, using the coded ribbons 702. The ribbons are easily visible because of the |ensframe 706 being folded into the open position. The lengths of the ribbons 702 are selected so as to avoid unintentional contact with the outer surface of the hood 704. In the process of pulling the front 704a (grey) towards the user’s chest and the back 704b up and over the user’s head, the |ensframe will fold automatically into operational position, where a transparent window portion 1002 (hereinafter ed to as lens 1002) of the hood front 704a is positioned over |ensframe 706. shows an exemplary pivot-point-type swivel mechanism, and shows an exemplary slotted-link-type swivel mechanism. One or both of these mechanisms may be employed in embodiments of the disclosure. The swiveling TH|101WOP action of the lensframe 706 is a rotation around pivot points 1202 (shown in broken lines in ) or a sliding motion along a slotted link formed by slot 1302 (shown in broken lines in ) in head unit 708 and tab 1304 of lensframe 706.
With reference now to , relative to a vertical line, the lensframe 706 (and therefore also the lens 1002) is tilted towards the chin area (at an angle of x°).
This angle promotes concentration of fresh air flow around the user’s nose and mouth, maximizes field of vision towards the patient, and creates room inside the hood at the forehead for optimum aerodynamics and accessories such as an LED light (shown in ) and a camera (not shown). shows that the lens 1002, as a vision element, is designed as a curve around the user’s face area, utilizing an upper radius R1 around the head’s vertical centerline and a lower radius R2 around the same centerline. In some embodiments, both radii are the same. shows an embodiment of a surgical helmet 1600 in one embodiment of the disclosure, comprising dual head-lamps 1602,1604 and a lens-alignment clip 1606. Conventional surgical helmets lly include only one head-lamp. Through edback, the inventors ered that one head-lamp is unsatisfactory, because it es a narrowly d beam that is often too dim for al purposes. The inventors solved this problem by providing two head-lamps.
Free-Flow Main Air Duct Embodiments of the disclosure may include a free-flow main air duct. FIGs. 17 and 18 show an exemplary free-flow main air duct, in one embodiment of the disclosure.
Because of ergonomic reasons (weight balance), main intake airfans (e.g., fan 208) are commonly located at the back of the head. This es fresh air to be channeled fonNard towards a nozzle located in the proximity of the forehead by means of an air duct. Additionally, the upper part of the head (above the hairline) should be d with fresh, cool air during use. Furthermore, for a positive ergonomic fit of the system, the helmet assembly should have a relatively low weight and low center of gravity.
As shown in FIGs. 17 and 18, head unit 708 comprises an air duct assembly including one upper surface 1302, two side bounding surfaces (e.g., 1704), and at least one bottom opening (e.g., 1802), arranged such that a fourth bounding surface TH|101WOP (or barrier) 1706 is partially formed by the upper part of the skull itself. This configuration allows a reduction of weight, while keeping the head flush above the hairline.
Automatic Airflow Control Embodiments of the disclosure may include automatic airflow control. With reference now to , an exemplary automatic airflow control system 1900 in one embodiment of the disclosure is shown.
Automatic airflow control automatically compensates for the microc|imatic effects of varying factors, such as physical activity or mental stress levels during surgical procedures, thereby reducing the need for manual adjustment of fan speed during use. This leads to an increased focus on the surgical tasks at hand, as well as a reduced amount of intentional contact between hand and oga, which are by nature ial sources of contamination.
As shown in , one or more sensors 1902 e direct or indirect |imatic conditions inside the e hood. The sensors 1902 may be located anywhere within hood 702. In one embodiment, the sensors 1902 are positioned on an electronic board (not shown) that is mounted on the head unit 408.
Sensors 1902 are connected to a controller 1904 that is configured to receive one or more sensor signals and generate a fan-speed-control output signal based thereon. In one ment, controller 1904 comprises a fan-speed-adjustment (FSA) algorithm that converts the one or more sensor signals into a rate-of-change signal and further translates it (e.g., via an amplifier, a level-shifter, an analog-to- digital converter, a l-to-analog converter, or an thm corresponding to such devices) into an output signal that is sent to the eed control unit 1906. The controllers output signal includes, e.g., the specific information of desired rate of change to the fan speed (RPM) over time and the direction of change ase or decrease). Finally, variable-speed fan 1908 operates at a speed that is determined by, and corresponds to, the fan-speed control unit’s output signal.
In one embodiment, the controller 1904 is a digital processor having software that is configured based on a user’s specific al need or an operating-room or field condition, including, e.g., ambient temperature and ambient sunlight. The digital TH|101WOP processor may be a general microprocessor, a digital signal processor, or a digital ontroller.
Controller 1904 and fan-speed control unit 1906 each may comprise an analog control circuit, a digital processor, a signal processor, or any combination thereof, in accordance with techniques known to those of ordinary skill in the art of control circuitry. Controller 1904 and fan-speed control unit 1906 also may be connected to an audio or visual signaling device (not shown) to indicate the selected fan speed to the user.
Embodiments of the disclosure may include one or more of the following sensor features: 1. Absolute and/or differential temperature measurement, using two temperature sensors, measuring both intake air ature and the air temperature inside the hood (exhaust air temperature); 2. Humidity sensing, measuring relative humidity of air inside the hood, using a humidity sensor; 3. C02 g, measuring absolute C02 levels, e.g., by using a non- sive infrared detector (NDIR); 4. Motion g, measuring static and dynamic acceleration of the head as a representation of physical activity (and therefore g performance), e.g., via one or more rometers; . Position or inclination sensing, e.g., via a position sensor or an inclinometer. 6. Voice sensing, e.g., via a microphone; 7. Voice-recognition sensor, e.g., via a microprocessor-based portable computer or smartphone connected to controller 1904 by a wired or wireless interface; and 8. Proximity sensing, e.g., by a tive, infrared, or lectric sensor. shows an embodiment in which the sensors 1902 comprise a motion sensor d on head unit 708. In block 2002, the motion sensor detects one or more head movements. In block 2004, the FSA algorithm in controller 1904 determines the quality and quantity of the user’s activity based on the detected one or more head movements. In block 2006, the fan-speed control unit automatically TH|101WOP adjusts the fan speed based on the determined user activity. For e, during periods of high activity, the controller 1904 produces an output signal that causes the fan-speed control unit 1906 to increase the fan speed. Conversely, during periods of low activity, the controller 1904 es an output signal that causes the fan-speed control unit 1906 to decrease the fan speed.
At any time during the use of the system, the user can increase or decrease the fan speed manually to adjust the microclimate to his or her actual personal preferences. Such manual adjustment is bly performed using the touchless user ace, which is described below.
Touchless User Interface Embodiments of the disclosure may include a touchless user interface. shows an exemplary method for a user to employ a touchless user interface, in one embodiment of the disclosure. As shown, the user’s forearm, wrist, and/or hand approaches his or her chin area up to a distance between 3 cm and 10 cm, and more preferably n 4 cm and 7 cm, and most preferably 5 cm, from the lens frame, always controlling his or her arm position and distance to the sterile hood 702 through visual t with his or her hand. A proximity sensor (e.g., 1902 in ) detects the approach and transmits a control signal to a signal processor (e.g., controller 1904 in ). The system acknowledges the signal input with audible and/or visual feedback to the user.
In this ment, a capacitive or photoelectric sensor is used as a proximity sensor. State-of-the-art photoelectric sensors are advantageous because of their capability of measuring distance between the sensor and the sensor target. This allows the sensor to discriminate between hand gestures and reduce the risk of unintended inputs by the user. rmore, lectric sensors can compensate for transparent materials masking the sensor area. In this embodiment, such compensation is relevant because the sensor is located behind the arent, sterile lens of the hood 704.
Once the sensor input is in line with predefined parameters (e.g., the distance n the user’s hand and the sensor), the sensor transmits a signal to a signal- processing unit (e.g., controller 1904). Further processing is described above under the heading "Automatic Airflow Control." TH|101WOP shows another exemplary method for a user to employ a touchless user interface, in an embodiment of the disclosure. In this embodiment, a motion sensor is mounted on head unit 708. Controller 1904 is configured to monitorthe movements of the user’s head and to interpret one or more predetermined movements of the user’s head (e.g., an ral backward head tilt as shown in image 2202) as a specific user input or command. Controller 1904 is further configured to control the fan or other accessories (such as a light or other device) and/or to switch between a manual fan-control mode to an automatic fan-control mode, based on the user’s command. In one embodiment, controller 1904 is also configured to respond to a command by generating an audible sound or a visual signal.
Thus, in block 2204, controller 1904 determines that a user’s motion corresponds to a predetermined user input. In block 2206, in response to the user input, controller 1904 produces a confirmation sound. And in block 2208, controller 1904 es a corresponding output signal, e.g., corresponding to an automatic eed mode-control setting, a specific manual fan speed, and/or a control setting.
In one embodiment, controller 1904 is configured to e a user-adjustable, automatic fan-control mode that combines both automatic fan-speed control and manual fan-speed control. The FSA algorithm in controller 1904 automatically selects a fan-speed setpoint that is a function of a temperature gradient, but it also allows the user to adjust the tically selected setpoint to a higher or lower point, according to the users needs. is a plot showing fan speeds automatically selected by the FSA algorithm at ent temperature gradients. In one embodiment, the FSA algorithm employs five levels of user adjustability s 1 through 5), as shown in the following table: TH|101WOP I Shiftfan speed algorithm up by equivalent of one level and produce a single audio signal.
Signal < 2 sec I lfa/ready at level 5, shift FSA down to level 1 and produce a double audio signal.
I Each FSA level has his specific audio signalfrequency Signal > 2 sec I Switch Light on/off I FSA does adjustfan speed dynamically, based on dT, dRH, dCOZ level or head motion input t Signal I Autonomous FSA adjustment without audio signal and not recognizable by user due to step/ess adjustment Repower the system after I Shiftfan speed algorithm to equivalent offan Level 3 disruption (battery disconnection) Reference herein to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic bed in connection with the embodiment can be included in at least one embodiment of the disclosure. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments arily mutually exclusive of other embodiments.
Although the disclosure has been set forth in terms of the exemplary embodiments described herein and illustrated in the attached drawings, it is to be understood that such disclosure is purely rative and is not to be interpreted as limiting. Consequently, various alterations, modifications, and/or alternative embodiments and applications may be suggested to those skilled in the art after having read this disclosure. Accordingly, it is intended that the disclosure be interpreted as assing all alterations, cations, or alternative ments and applications as fall within the true spirit and scope of this disclosure.
TH|101WOP

Claims (14)

1. A barrier system, said system comprising: a head unit shaped to be worn over a wearer's head; a hood positioned over the head unit and forming a chamber; one or more sensors located within the chamber and configured to produce one or more sensor-output signals, the one or more sensors comprising one or more motion sensors mounted on the head unit; and a controller connected to the one or more sensors and configured to e one or more controller-output signals based on the one or more sensor-output signals, where the one or more controller-output signals are based on a predetermined head movement of the wearer's head positioned in the head unit; a eed control unit connected to the ller; and a fan connected to the fan-speed l unit; wherein the fan-speed control unit is configured to automatically increase or se a fan speed based on the one or more controller-output signals ponding to the predetermined head movement of the 's head positioned in the head unit.
2. The barrier system of claim 1, wherein the one or more sensors are configured to detect one or more of: ambient temperature, chamber temperature, intake-air temperature, exhaust-air temperature, humidity, CO2 level, motion, position, inclination, voice sounds, voice-recognized words, and an object's proximity.
3. The barrier system of claim 1, wherein: the one or more sensors comprise a proximity sensor positioned near the head unit; and the controller is configured to produce the one or more ller-output s based on a predetermined distance of the proximity sensor to an object.
4. The barrier system of claim 1, further comprising a signaling device connected to the controller, wherein the controller is configured to activate the signaling device.
5. The barrier system of claim 1, wherein the controller comprises a fan-speed-adjustment algorithm that converts the one or more sensor signals into a f-change signal.
6. The barrier system of claim 1, wherein: the controller comprises either (a) at least one of the following ts: (1) an amplifier, (2) a shifter, (3) an analog-to-digital converter, and (4) a l-to-analog converter, or (b) an algorithm corresponding to one or more of such circuits, and the controller is configured to translate the one or more -output signals into the one or more controller-output signals either by connecting the one or more sensor-output signals to at least one of the circuits identified in (a)(1) through (a)(4) above, or by executing an algorithm corresponding to such circuits.
7. The barrier system of claim 1, wherein the one or more controller-output signals includes at least one of (a) information about a desired rate of change to the fan speed over time and (b) the direction of a desired change.
8. A method of controlling a device inside a r system comprising a head unit, a hood, one or more s, and a controller, the method comprising: (a) sensing one or more characteristics; (b) producing one or more sensor signals based on the sensed one or more characteristics, where the sensed one or more characteristics is the head unit's movement and the one or more sensor s produced is based on a predetermined head movement of the wearer's head positioned in the head unit; (c) converting or processing the one or more sensor signals to produce one or more controller-output signals; and (d) controlling the device based on the one or more controller-output s; (e) automatically increasing or decreasing a speed of a fan based on the one or more controller-output signals corresponding to the predetermined head movement of the wearer's head positioned in the head unit.
9. The method of claim 8, wherein the one or more characteristics comprise one or more of: ambient temperature, chamber temperature, intake-air temperature, exhaust-air temperature, humidity, CO2 level, motion, position, inclination, voice sounds, recognized words, and an object's proximity.
10. The method of claim 8, n a characteristic of the sensed one or more characteristics is an object's proximity to the head unit, and step (b) ses producing the one or more sensor signals based on a predetermined proximity.
11. The method of claim 8, further comprising activating a signaling device.
12. The method of claim 8, wherein the converting or processing the one or more sensor signals to produce the one or more controller-output signals comprises converting the one or more sensor signals to one or more rate-of-change s.
13. The method of claim 8, wherein the converting or processing the one or more sensor s to produce the one or more controller-output signals comprises at least one of the following: (a) amplifying the one or more sensor signals, (b) level-shifting the one or more sensor signals, (c) converting the one or more sensor signals from analog signals to digital signals, (d) converting the one or more sensor signals from digital signals to analog signals, and (e) ing an algorithm that is ured to e an output corresponding to one or more of steps (a) through (d).
14. The method of claim 8, wherein the converting or processing the one or more sensor s to produce the one or more controller-output signals comprises at least one of: (a) determining a desired rate of change to the fan speed over time, and (b) determining a direction of a desired change. Thi Total Healthcare Innovation GmbH By the Attorneys for the Applicant SPRUSON & FERGUSON Per:
NZ744301A 2016-01-07 2017-01-07 Donnable barrier devices, systems, and methods with touchless control NZ744301B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662275995P 2016-01-07 2016-01-07
US62/275,995 2016-01-07
PCT/US2017/012654 WO2017120562A2 (en) 2016-01-07 2017-01-07 Donnable barrier devices, systems, and methods with touchless control

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NZ744301B2 true NZ744301B2 (en) 2021-06-29

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