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WO2014189364A1 - Masque chirurgical jetable - Google Patents

Masque chirurgical jetable Download PDF

Info

Publication number
WO2014189364A1
WO2014189364A1 PCT/NL2013/050382 NL2013050382W WO2014189364A1 WO 2014189364 A1 WO2014189364 A1 WO 2014189364A1 NL 2013050382 W NL2013050382 W NL 2013050382W WO 2014189364 A1 WO2014189364 A1 WO 2014189364A1
Authority
WO
WIPO (PCT)
Prior art keywords
spacer
face shield
disposable surgical
wearer
sheet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/NL2013/050382
Other languages
English (en)
Inventor
Paavo Lasse Freijzer
Stephanus Franciscus Schilthuizen
Jacobina Gertruda Theodora Maria BOKKEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LICA HOLDING BV
Original Assignee
LICA HOLDING BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by LICA HOLDING BV filed Critical LICA HOLDING BV
Priority to PCT/NL2013/050382 priority Critical patent/WO2014189364A1/fr
Publication of WO2014189364A1 publication Critical patent/WO2014189364A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • A41D13/1184—Protective face masks, e.g. for surgical use, or for use in foul atmospheres with protection for the eyes, e.g. using shield or visor

Definitions

  • the present invention relates in general to a disposable medical or surgical face shield for protecting the face of a wearer from particles, fragments, droplets, and/or splashes specifically particles, fragments, droplets, and/or splashes containing biological and other hazards and for providing means and methods for a clear and good view through the face shield.
  • the present invention also relates to a method for manufacturing a disposable surgical face shield.
  • Medical professionals are exposed daily or frequently to blood, saliva, interstitial fluids, other body fluids and partly liquid and/or solid body materials that may carry infectious bacteria, viruses and materials or other blood borne or body fluid pathogens.
  • medical professionals be protected from the potentially hazardous body fluids of the patient and that the patient is protected from the potentially hazardous body fluids of the medical professionals or the patient's own hazardous body fluids that may ricochet and/or drip off the medical professionals' protective clothing.
  • the medical personnel performing the operation have a clear view on and of the human tissues they're operating upon when wearing any kind of facial protection.
  • US 5,440,760 discloses a disposable face shield that comprises a transparent plastic shield and a stretchable or elastic cord for securing the shield about the wearer's face.
  • a crescent-shaped foam member is affixed to the transparent plastic shield at an upper-central spot.
  • the transparent shield is of an appropriate size to protect substantially the entire facial region of an average adult.
  • the shield being mounted to the forehead region of the wearer causes the shield to flex, deflect and move during use. This causes disturbances in the line of sight of the wearer, which may be a nuisance especially during complex medical procedures.
  • CN201718520 discloses a face shield in which the stability of the shield as been improved by addition of a sponge bracket at the location of the nose bridge of the wearer.
  • This face shield is, however, not suitable for use during medical procedures as its line of sight is optimized for vehicle drivers and not for use during medical procedures.
  • a disposable surgical face shield including a flexible liquid-impermeable sheet, which is transparent at least in the viewing region, and is arranged to extend over the forehead region of the wearer and the nostrils and mouth of the wearer.
  • the face shield comprises a securing means for securing the shield to the head of the wearer.
  • the face shield comprises a first spacer attached to the sheet and arranged to abut against the face of the wearer above the eyes, e.g. just above the eyes, and a second spacer attached to the sheet and arranged to abut against the nose bridge and/or cheeks of the wearer.
  • the second spacer is inclined such that when the shield is mounted to the head of the wearer a proximal area of the second spacer proximal to the eyes of the wearer is positioned higher than a distal area of the second spacer distal to the eyes of the wearer.
  • nostrils refers to the openings of the nose through which air can be inhaled and exhaled.
  • the second spacer is inclined such that when the shield is mounted to the head of the wearer a proximal area of the second spacer proximal to the eyes of the wearer is positioned higher than a distal area of the second spacer distal to the eyes of the wearer the field of view through the sheet is optimized.
  • the inclined second spacer allows virtually
  • the spacer has sufficient rigidity and/or form -stability to maintain the sheet spaced from the face of the wearer while transferring the load of the shield onto the nose bridge (and optionally the cheeks as will be discussed below) of the wearer, which improves the overall stability of the face shield in use.
  • the sheet when disengaged from the wearer's face is substantially flat. In this case it is easier to manufacture, transport and store the disposable surgical face shields.
  • the sheet is a self supporting sheet or a single monolithic self supporting sheet.
  • the first and/or second spacer can be resilient and compressible, so as to form a comfortable seal between the respective spacer and the wearer's face. This can be enhanced by providing that the surface of the respective spacer which touches the skin has a high friction coefficient and/or is sticky. It is possible that the respective spacer returns to its original form after being compressed. It is also possible that the respective spacer does not return to its original form after a finite number of compressions.
  • first spacer being attached to the sheet and positioned to abut against the face of the wearer above the eyes
  • second spacer being attached to the sheet and positioned to abut against the nose bridge of the wear improve the stability of the face shield when worn.
  • the second spacer is mounted to the sheet already in an inchned fashion.
  • This provides an easy way to make sure that the second spacer is inclined such that when the shield is mounted to the head of the wearer a proximal area of the second spacer proximal to the eyes of the wearer is positioned higher than a distal area of the second spacer distal to the eyes of the wearer.
  • the second spacer may be mounted in an inclined fashion to the substantially flat sheet. This provides an easy way of manufacturing the face shield.
  • the disposable surgical face shield comprises a support element including a seat arranged for supporting the second spacer.
  • the disposable surgical face shield includes two support elements for supporting a first end of the second spacer and a second end of the second spacer.
  • the seat of the support element is angled to correspond to the inclination of the inchned second spacer.
  • the support element is attached to the substantially flat sheet.
  • the second spacer is also attached to the substantially flat sheet and the second spacer is preferably attached to the seat or at least contacts the seat of the support element.
  • the support element(s) is (are) positioned to abut against the cheeks of the wearer, when worn.
  • the use of a support element may allow for the second spacer to be manufactured from a wider range of materials.
  • the support elements are additionally arranged to abut against the cheek area of the wearer's face. Therefore the support element may include an addition comfort layer to improve the wearing experience of the disposable face shield.
  • the second spacer comprises an inverted V-shape.
  • the upward point of the inverted V-shape abuts against the bridge of the wearer's nose.
  • the inverted V-shape provides good fit to the nose bridge of the wearer and can have optionally a smaller thickness at this point to facilitate also a better view downward past the nose itself.
  • the second spacer is arranged to assume an inclined shape after the bending of the transparent sheet to which it is attached.
  • the second spacer is mounted to the sheet substantially perpendicularly, and the second spacer comprises an inverted V-shape.
  • the height of the second spacer, measure perpendicular to the substantially flat sheet, and the thickness of the second spacer, measured parallel to the sheet in a cranial direction is chosen such that the second spacer buckles when the sheet is bent to conform to the face of the wearer when worn such that the second spacer is inclined such that the proximal area of the second spacer is positioned higher than a distal area of the second spacer.
  • height of the second spacer is chosen larger than the thickness of the second spacer.
  • the height is 1.5 or more times larger than the thickness, more preferably 2 or more times, such as 2.5 or more times or 3 or more times.
  • the second spacer has lateral extent sufficient to extend over the cheeks of the wearer. This provides the advantage that the second spacer bears not only on the nose bridge of the wearer, but also on the cheeks, so as to distribute pressure more evenly over the face of the wearer, increasing comfort.
  • a thickness of the second spacer measured parallel to the sheet in the cranial direction, increases from the center outwardly.
  • a thickness of the second spacer measured locally perpendicularly to the spacer, and parallel to the sheet, increases from the center outwardly.
  • a height of the second wall measured perpendicular to the sheet decreases from the center outwardly. This can improve stability of the shield when worn. This can also aid in obtaining the desired inclined orientation of the second spacer when the face shield is mounted to the head of the wearer. This can also compensate for the effect of the second spacer pivoting away from the face when the second wall buckles when the sheet is bent.
  • the disposable surgical face mask includes a chin support.
  • the chin support forms a spacer mounted to the face shield and positioned to abut against the chin of the user, when worn. This provides further stabilization of the face mask with respect to the face of the user.
  • the chin support can e.g. be a foam block, or a lip-like spacer (e.g. angled downwardly towards the throat of the user, when worn).
  • the second spacer is impermeable to vapor and/or gases.
  • the second spacer forms a vapor barrier and prevents vapor from the wearer's breath exhaled from the mouth and/or nostrils from entering and fogging the viewing region.
  • the impermeability to vapor can e.g. be achieved by coating a surface of the second spacer, e.g. the surface directed towards the mouth and nostrils, with a vapor impermeable coating or a vapor
  • the second spacer can be made of a sandwich material having at least one layer being impermeable to vapor and gases.
  • the second spacer can be permeable to gases, such as air, but has the ability to absorb warmer vapor and moisture parts which primarily contribute to the so-called fogging effect. This can be achieved via use of woven, knitted or non-woven textile materials, foams etc, in the second spacer.
  • the first spacer comprises -one or a plurality of ventilation apertures for ventilating the viewing region. These ventilation apertures also aid in preventing fogging of the viewing region in the event of moisture build-up in the viewing region, e.g. in case of perspiration.
  • the disposable surgical face shield can be kept fog and moisture free in the viewing region, yet remains comfortable for the wearer owing to the ventilation apertures in the upper wall.
  • the ventilation apertures are inherent to a material used to construct the first spacer.
  • An example of a venting material is a spacer fabric or a with textile coated open cell foam material.
  • the second spacer comprises, or is made from, a closed cell foam.
  • the closed cell foam provides the vapor barrier.
  • the first spacer comprises, or is made from, an open cell foam.
  • the open cell foam provides also a barrier against liquid droplets and/or liquid splashes, while being comfortable to wear.
  • first and second spacer are connected by side spacers to form a circumferential spacer arranged to enclose the viewing region including the eyes and excluding the nostrils and the mouth.
  • the circumferential spacer encloses and provides protection to the viewing region, which includes the eyes and facial regions directly adjacent to the eyes.
  • the viewing region is hence well protected from liquid droplets and/or liquid splashes that fall behind the shield or land on the head of the wearer and drip behind the shield.
  • the circumferential spacer is contoured and varies in thickness and/or height. This provides a better fit for wearers with and without eyeglasses, or wearers with larger or smaller facial features.
  • the first, second and/or side spacers are provided with a textile layer at the surface opposite the sheet, i.e. the surface abutting against the face, when worn. This can increase comfort of wearing and can absorb perspiration.
  • the circumferential spacer has facetted or rounded corners with large radii at the left and right end of the contoured spacer, which can be used to incline the right and left sides of the transparent shield in permanent or semi-permanent way to the spacer. This provides a better protection of the left and right side of the face and eye and ear areas of the user and a better fit to the contour of the head of the wearer.
  • the securing means is arranged to tighten and hold the disposable surgical face shield in front of the wearer's face.
  • the securing means is one of e.g. an elastic strap, an adjustable elastic strap, a hook and loop (Velcro) strap, ear loops, head harness, and adhesive such as a silicone adhesive.
  • the securing means can be attached to the sheet such that in use the securing means causes the flexible liquid-impermeable to bend around the wearer's face.
  • the shape induced by the securing means is ideal for protecting the wearer.
  • the securing means can be attached to the sheet e.g. by at least one of a weld, an ultrasonic bond, a slot, a rivet, and an adhesive.
  • the securing means is attached to the first spacer e.g. by at least one of a weld, an ultrasonic bond, a slot, a rivet, and an adhesive.
  • the securing means is attached to an inside surface of the sheet, e.g. the same side as the first spacer.
  • the securing means is attached to an outside surface of the sheet.
  • the sheet is transparent at least in the viewing region such that in use the wearer's vision is not inhibited.
  • the sheet outside the viewing region is opaque or partially opaque.
  • the sheet may be (partially) opaque outside the viewing region due to the inherent properties of a material of the sheet or due to a coating or laminated layer.
  • the sheet outside the viewing region comprises a non-reflective material for preventing unwanted reflections of light during a medical procedure.
  • the sheet can optionally have an integrally formed cavity for the nose.
  • a nose cavity can e.g. be provided in the sheet by means of thermoforming or vacuum forming.
  • Such nose cavity provides a higher stiffness of the sheet and allows reduction of the thickness of the first and/or second spacer.
  • This nose cavity can partly or wholly surround the nose. Another advantage is that such nose cavity results in a smaller distance between the eyes and the transparent part of the sheet which enhances the sight and vision of the wearer.
  • the sheet is preformed such that when worn the viewing region is closer and more closer and parallel to vertical center line to the eyes like glasses or spectacles than the non-viewing region is to the remainder of the face.
  • the viewing region can be parallel to a vertical center line of the shield.
  • the viewing region can extend at a distance from the eyes that corresponds to a normal back vertex distance (BVD) for glasses, e.g. 10-15 mm, preferably 12-13 mm, from the cornea, to provide improved vision through the viewing region.
  • BBD back vertex distance
  • the second spacer can be inclined such that when the shield is mounted to the head of the wearer a proximal area of the second spacer is positioned higher than a distal area of the second spacer. It will be appreciated that hence the second spacer, and/or the first spacer, can be at least partially formed by one or more preformed
  • the first spacer can be arranged to abut against the wearer's face above the eyes and preferably just above the eye brows of the wearer.
  • the side spacers can be arranged to abut against the wearer's face to the right and left of the wearer's right and left eyes respectively, and preferably against the wearer's temple regions, behind the most outward extreme of the eye socket.
  • the second spacer wall is arranged to abut against the wearer's face above the nostrils and/or under the eyes. Optionally, the second spacer abuts against the face under the eyes in the cheek bone region.
  • the first spacer includes an absorption strip arranged to abut against the wearer's face.
  • the absorption strip absorbs sweat and provides a generally more comfortable wearing experience.
  • the second spacer comprises an inner wall adjacent to the viewing region.
  • the inner wall of the second spacer includes an anti- glare strip. This strip reduces the amount of light reflected into the wearer's eyes.
  • the viewing region includes an anti-glare strip.
  • the anti-glare strip is located just above the eyes and shields the wearer's eyes from harsh overhead lighting.
  • the side spacers comprise an inner wall adjacent to the viewing region including anti-glare strips.
  • the sheet is arranged to extend over the nostrils and mouth of the wearer, and optionally to extend over the chin. Additionally, the sheet is arranged to extend beyond the first spacer such that it extends over the forehead region of the wearer, and optionally to top of the forehead region of the wearer.
  • a protective cloth is attached to a top edge of the sheet and is arranged to extend over the top of the wearer's head.
  • a protective cloth is attached to a bottom edge of the sheet and is arranged to extend over the chin and the neck region of the wearer.
  • the protective cloth is made from a venting material and/or is impermeable to liquid, like a coated or chemically treated textile fabric.
  • the protective cloth extends over and around the wearer's entire head. It is also possible that the face shield is provided with an protective wall extending below the chin of the user, when worn.
  • the protective wall can be made from a venting material and/or is impermeable to liquid.
  • the protective wall can be made of foam.
  • the protective wall is mounted to the sheet slanting downwardly towards the throat of the user, when worn.
  • a protective cloth is attached to the skin side or sheet side of second spacer, and is arranged to extend over the mouth and the neck region of the wearer.
  • the sheet is arranged to extend over the temple regions of the wearer.
  • This embodiment provides additional protection for liquid droplets and liquid splashes directed at the sides of the wearer's head.
  • the spacers e.g. the first spacer, the second spacer and/or the side spacers, are arranged to be impervious to droplets and/or splashes of liquid.
  • the ventilation apertures can also be impervious to liquid droplets and/or liquid splashes
  • the ventilation apertures can e.g. be covered by a covering material, such as a woven or non-woven or circular or flat knitted textile fabrics that allows air to pass but catches and absorbs, holds or deflects liquid droplets and/or liquid splashes.
  • the ventilation apertures are made from a first material or are inherent to a first material having sufficient hydrophobic properties to prevent liquid droplets from passing through the material.
  • the hydrophobic surface characteristics may be inherent to the material or be provided by a coating or plasma treatment.
  • the first material may be used in combination with a second material, also including ventilation apertures, having hydrophilic properties to absorb, catch and/or hold liquid droplets that pass through the first material. It is also possible that the hydrophobic and hydrophilic properties are achieved by applying finishes and/or coatings to the first material and/or second material.
  • the desired properties may also be achieved by various solutions including but not limited to: closely knit or woven fabrics with hydrophobic and/or hydrophilic finishes or coatings; monolithic films which provide ventilation and form a barrier against liquid droplets; printed structures with higher and lower hydrophobic surface characteristics; nanoneedles in a coating; Gore-Tex like materials; PU coatings; and 3D textiles. It is also possible that the ventilation apertures have a geometry, such as a labyrinth, that allows passage of ventilation gases, but prevents passage of droplets.
  • the spacers are arranged to catch droplets and/or splashes of liquid.
  • the spacers e.g. the first, second and/or side spacers, are arranged to absorb droplets and/or splashes of liquid.
  • the spacers e.g. the first, second and/or side spacers, are arranged to hold droplets and/or splashes of liquid. Due to the high absorption ability and/or hydrophilic properties of the spacers, liquid droplets and splashes of liquid can be caught, held, and/or absorbed by the spacers or a portion thereof. Therefore liquid droplets and liquid splashes can be prevented from entering the viewing region.
  • the sheet includes, e.g. is made from, a liquid repellent material at least in the viewing region.
  • the sheet includes, e.g. is made from, a hydrophobic material at least in the viewing region.
  • the sheet includes, e.g. is made from, a liquid absorbent material at least outside the viewing region.
  • the sheet includes, e.g. is made from, a hydrophilic material at least outside the viewing region.
  • the sheet has a liquid repellent coating at least in the viewing region.
  • the sheet has a hydrophobic coating at least in the viewing region.
  • the sheet has a liquid absorbent coating at least outside the viewing region.
  • the sheet has a hydrophilic coating at least outside the viewing region.
  • the sheet could e.g. be made from a liquid repelling material and have a hydrophilic coating outside the viewing region, or be made from a hydrophilic material and have a liquid repelling coating inside the viewing region.
  • the sheet could e.g. be made from a liquid repelling material and have a hydrophobic coating or is made from an a-polar polymer material inside and outside the viewing region which allows droplets to quickly roll down the sheet to an element capable of absorbing and capturing these droplets.
  • Liquid droplets or liquid splashes that land on the sheet could slide off the sheet and drip onto the patient being treated. It is possible that the liquid carries a pathogen. When the contaminated liquid drips off the face shield and onto the work area, such as the patient, or even worse into the patient via an incision, wound, or opening, the patient could be come infected.
  • An absorbent strip could catch, absorb, and/or hold the potentially hazardous liquid. Such strips are most effectively placed on the edges of the face shield and below the viewing area. It is conceivable that in certain medical environments during certain medical procedures a plurality of strips may be necessary to catch, absorb and/or hold all liquid that comes in contact with the face shield.
  • the sheet therefore includes a strip of a super absorbent material arranged to catch, absorb and/or hold droplets of liquid that land directly on the strip or slide from the sheet into the strip.
  • the sheet includes a plurality of strips of a super absorbent material.
  • the strip of super absorbent material is attached to an edge of the sheet.
  • a strip of super absorbent material extends across a bottom of the sheet substantially parallel to a bottom edge of the sheet.
  • a strip of super absorbent material extends across a top of the sheet substantially parallel to a top edge of the sheet.
  • the super absorbent material is a super absorbent polymer.
  • the super absorbent material is a woven textile or knitted textile material comprising micro polyester fiber or super micro polyester fibers capable of capturing a number of droplets.
  • a protective cloth is attached to the skin side or sheet side of second spacer or the lower end of the transparent sheet and extends over the mouth and the neck region of the wearer and is able to catch and absorb liquid droplets or liquid splashes, preventing them to fall back to patient or surgery area.
  • the sheet includes an antimicrobial substance arranged to interact and inhibit the growth of one of a bacteria, viruses, algae, and fungi (microbes).
  • the substance may be inherent to the material of the sheet, or added to the sheet e.g. in the form of a coating or a
  • the strip includes an antimicrobial substance arranged to interact with and/or inhibit the growth of one of a bacteria, viruses, algae, and fungi (microbes).
  • the antimicrobial substance is a metal ion such as a silver ion.
  • the antimicrobial substance has a natural basis from plants and herbs.
  • the spacers are attached to the screen by at least one of a weld, an ultrasonic bond, a rivet, and an adhesive.
  • a method for manufacturing a disposable surgical face shield comprising: providing a flexible liquid-impermeable sheet being dimensioned to extend over substantially the entire facial region of a wearer, wherein the sheet is transparent at least in a viewing region; providing a securing means; providing a first spacer and a second spacer; attaching the first spacer to the sheet such that it is positioned to abut against the wearer's face above the eyes; attaching the second spacer to the sheet such that it is positioned to abut against the wearer's nose bridge such that when the shield is mounted to the head of the wearer the second spacer is inclined such that a proximal area of the second spacer proximal to the eyes of the wearer is positioned higher than a distal area of the second spacer distal to the eyes of the wearer
  • the step of attaching the second spacer to the sheet further includes the step of attaching a support element to the substantially flat sheet with flat sides on the contact surfaces with the transparent sheet.
  • the step of attaching a support element to the substantially flat sheet is performed prior to the step of attaching the second spacer or this is pre-assembled in production. In this way an improved connection between the substantially flat sheet and the second spacer is achieved due to the flat glueing or connection surfaces.
  • a disposable surgical face shield including a liquid-impermeable screen arranged to extend over at least a viewing region including the wearer's eyes and a securing means.
  • the screen includes a display.
  • the screen is provided with electrical contacts for interfacing to and controlling the display with a control unit. Therefore the surgical face shield including the display can be discarded, but the control unit controlling the display can be reused.
  • a disposable surgical face shield including a liquid- impermeable screen arranged to extend over at least a viewing region including the wearer's eyes and a securing means is used in an assembly further including a display and a control unit wherein the display and control unit are releasable connected to the face shield.
  • the display is adhered to the screen, e.g. by means of a re- adherable adhesive (multi-use), static adhesive, auto-collant, or windscreen- sticker effect. Therefore the surgical face shield can be discarded, but the display and control unit controlling the display can be reused.
  • the display is included on an inside of the face shield to prevent damage and/or contamination to the display.
  • the screen is arranged to extend over the forehead region of the wearer, and the screen is arranged to extend over the nostrils and mouth of the wearer.
  • the screen protects the wearer's entire face.
  • the screen includes a display inside the viewing region.
  • the screen includes a display outside the viewing region.
  • the screen includes a display inside and outside the viewing region.
  • the display is transparent or semi-transparent. This is especially advantageous when the display is inside the viewing region.
  • the screen includes an organic light-emitting diode (OLED) display arranged for displaying information relating to the current surgical procedure.
  • OLED organic light-emitting diode
  • the OLED display is one of a passive matrix OLED display and an active matrix OLED display.
  • information In a medical procedure environment information must be communicated in a quick and efficient manner. Information regarding the current medical procedure or patient being treated must always be readily available to the medical professionals performing the procedure. If such information is displayed on the screen inside the viewing region, the wearer can make use of the screen as a head-up display.
  • real-time medical imaging such as from a camera, or previously acquired medical imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) and X-ray, could be displayed in the viewing region and e.g. appear to the wearer as an overlay on the patient.
  • MRI magnetic resonance imaging
  • CT computed tomography
  • X-ray X-ray
  • the display included in the screen could be utilized as an information monitor. It will be appreciated that (a processing unit of) the display may thereto be arranged to retrieve such information from a memory or database.
  • the disposable surgical face shield includes a wired or wireless receiver arranged to receive content to be displayed on the display.
  • the receiver is arranged to interface with the display via the control unit and electrical contacts of the screen.
  • the receiver is arranged to interface directly with the display via an interface.
  • the wireless receiver may make use of WiFi, Bluetooth, ZigBee, GSM, UMTS, UWB or the like.
  • the disposable surgical face shield includes a sensor and/or camera arranged to transmit signals to the control unit.
  • the control unit further comprises a processing unit arranged to determine what part of the patient is being viewed by the wearer from the transmitted signals from the camera and/or sensor.
  • the camera and/or sensor are releasable connected to the face shield to facilitate reuse.
  • the processing unit is arranged to interact with a medical image database to determine what portion of a medical image corresponds to the portion of the patient being viewed by the wearer.
  • the control unit may then cause the display to display a medical image corresponding to (overlaying with) the portion of the patient being viewed by the wearer.
  • the control unit and/or the receiver includes a network interface.
  • the content to be displayed on the display is controllable via a web application or mobile telephone application (smart phone app).
  • the display displays information related to vitals, such as heart rate, ECG, oxygen saturation (SpO2), carbon dioxide saturation (SpCO2), blood pressure (systolic/diastolic), respiratory rate, respiratory stroke volume, and temperature, of the patient being treated.
  • vitals such as heart rate, ECG, oxygen saturation (SpO2), carbon dioxide saturation (SpCO2), blood pressure (systolic/diastolic), respiratory rate, respiratory stroke volume, and temperature, of the patient being treated.
  • the processing unit may thereto be arranged to retrieve such information from an on-line measurement system measuring the information to be displayed.
  • the display displays camera images from a camera active in the medical treatment environment, such as an endoscopic camera.
  • the display included in the screen displays content related to the current medical procedure, such as instruction steps.
  • the display included in the screen displays MRI, CT, and/or X-ray images previously acquired or acquired in real-time.
  • the display displays
  • entertainment content such as movies, informational content related to the current medical procedure, and/or advertisements for the patient being treated.
  • Fig. 1 is a schematic representation of a front view of a disposable surgical face shield
  • Fig. 2a is a schematic representation of a disposable surgical face shield
  • Fig. 2b is a schematic representation of a side view of a disposable surgical face shield
  • Fig. 2c is a schematic representation of a disposable surgical face shield
  • Fig. 2d is a schematic representation of a side view of a disposable surgical face shield
  • Fig. 3a is a schematic representation of a disposable surgical face shield
  • Fig. 3b is a schematic representation of a side view of a disposable surgical face shield
  • Fig. 4 is a perspective top view of a disposable surgical face shield in use
  • Fig. 5 is a schematic representation of a rear view of a disposable surgical face shield, wherein the screen includes a display inside the viewing region;
  • Fig. 6 is a schematic representation of a front view of a disposable surgical face shield, wherein the screen includes a display outside the viewing region.
  • FIG. 1 depicts a disposable surgical face shield 1 disengaged from a wearer's face.
  • the disposable surgical face shield 1 includes a flexible liquid-impermeable sheet 2 for protecting a wearer from particles, fragments, droplets, and/or splashes.
  • the disposable surgical face shield 1 further includes a securing means 4.
  • the disposable face shield 1 further includes a first spacer 6 and a second spacer 8.
  • the first spacer 6 is positioned so as to be above the eyes of the wearer when the face shield 1 is worn by the wearer.
  • the second spacer 8 is positioned so as to abut against the nose bride of the wearer when the face shield 1 is worn by the wearer.
  • the first spacer 6 and the second spacer 8 are positioned outside a viewing region 10 of the face shield 1.
  • the securing means 4 is attached to the same side of the screen 2 as the circumferential spacer and includes a hook 5a and loop 5b portion for securing the face shield.
  • the shield 1 and sheet 2 are substantially flat.
  • sheet 2 is a monolithic self supporting sheet of transparent material, such as plastic.
  • the first spacer 6 and second spacer 8 each have a thickness appropriate for establishing a spacing between the sheet 2 and the wearer's face, preferably such that the wearer's nose does not come in contact with the sheet 2. It is conceivable that different spacer thicknesses need to be provided for wearers with and without eyeglasses or magnifying glasses, or wearers with larger or smaller facial features.
  • the second spacer 8 has an inverted V-shape.
  • the point of the V-shape abuts against the nose bridge of the wearer.
  • a thickness, t, of the second spacer measured parallel to the sheet 2 in the cranial direction increases when going outwardly from the center. It is also possible that a height, h, of the second spacer, when going outwardly from the center decreases. This may enhance the wearing comfort.
  • Figures 2a and 2b show a second embodiment of a disposable surgical face shield 1.
  • the face shield 1 shown in Figures 2 a and 2b is highly similar to the face shield 1 shown in Figure 1. The differences are as follows.
  • the first spacer 6 is provided with cutouts 12.
  • the second spacer 8 is provided with extensions 14 arranged to extend over the cheeks of the wearer when the face shield 1 is worn by the wearer. The extensions 14 can extend beyond the inverted V-shaped section of the second spacer 8.
  • the second spacer is inclined such that a proximal area 16 of the second spacer proximal to the eyes of the wearer is positioned higher in cranial direction than a distal area 18 of the second spacer distal to the eyes of the wearer.
  • the first spacer 6 is provided with angled ends 13.
  • the angled ends 13 slope away from the sheet 2 (in flat situation) at an acute angle.
  • the angled ends allow the sheet 2 to smoothly bend around the first spacer 6 when being worn by the wearer. This can also improve positioning of the sheet 2 along the temple regions of the wearer.
  • FIGs 2c and 2d show a further example of the second embodiment of a disposable surgical face shield 1.
  • the disposable face shield further comprises support elements 11 including a seat 13 arranged for supporting the second spacer.
  • a portion of the second spacer 8 has been cut away in order to better show the seat 13 of the support element 11.
  • the seat 13 of the support element is angled to correspond to the inclination of the inclined second spacer 8.
  • the support element is attached to the substantially flat sheet by an adhesive.
  • the second spacer 8 is attached to both the substantially flat sheet 2 and the seat 13 of the support element 11 by an adhesive.
  • a support element is provided at both a first end 8A and a second end 8B of the second spacer (see Figure 2a).
  • the support element 11 is manufactured using a therm oforming technique, via applying heat and pressure to a material.
  • a comfort layer 7 such as a textile, has been attached to the support element 11 to improve the wearing comfort of the disposable face shield 1.
  • the support element 11 is suitably positioned to abut against the cheeks of the wearer, so as to provide a stable and comfortable positioning of the face shield against the face of the wearer.
  • the support element may also be manufacture from other materials such as foam or expanded foams including EPS, EPP, and EPE. Additionally, the use of a support element 11 may allow for the second spacer to be manufactured from a wider range of materials such as foam having a textile liner, non-woven material, or thermoformed materials.
  • Figures 3a and 3b show a third embodiment of a disposable surgical face shield 1.
  • the face shield 1 shown in Figures 3 a and 3b is highly similar to the face shield 1 shown in Figures 2 a and 2b. The difference is as follows.
  • the second spacer 8 is positioned substantially perpendicular to the sheet 2 when the sheet is substantially flat when not engaging the head of the wearer.
  • the second spacer 8 comprises an inverted V-shaped section.
  • the height, h, of the second spacer 8, measure perpendicular to the substantially flat sheet 2, and the thickness, t, of the second spacer, measured parallel to the sheet in a cranial direction, are chosen such that the second spacer 8 buckles when the sheet 2 is bent to conform to the face of the wearer when worn.
  • This buckling in combination with the inverted V-shape, causes the second spacer to incline when the shield 1 is worn.
  • the inclination of the second spacer 8 in this case is also such that the proximal area 16 of the second spacer 8 is positioned higher in cranial direction than a distal area 18 of the second spacer 8.
  • the height, h, of the second spacer is chosen larger than the thickness, t, of the second spacer 8.
  • the height can be 1.5 or more times larger than the thickness, more preferably 2 or more times, such as 2.5 or more times or 3 or more times.
  • the second spacer 8 is pre-shaped prior to mounting the second spacer to the sheet 2. This pre-shaping can e.g. be done by shaping the foam material with or without textile covering under high temperature and/or high pressure as is known in the art. The pre-shaped second spacer 8 is glued to the sheet 2 in this example.
  • the second spacer 8 is provided with a vapor impervious material layer 9.
  • This impervious layer 9 is mounted to the surface of the second spacer 8 that is directed towards the mouth and nostrils when the shield 1 is worn. It will be appreciated that this layer 9 prevents exhaled breath from entering the viewing region 10 and fogging the sheet 2.
  • the layer 9 can also be used in the embodiments shown in the other figures.
  • the sheet 2 extends over substantially the entire facial region of the wearer 20.
  • the first spacer 6 is positioned above the viewing region 10.
  • the viewing region 10 includes the eyes 22 and excludes the nostrils 24 and the mouth 26 of the wearer 20. Since sheet 2 is formed as a single sheet of transparent material, sheet 2 is transparent both inside and outside viewing region 10.
  • the disposable surgical face shield 1 further includes side spacers 28 which abuts against the wearer's face to the right of the right eye, and to the left of the left eye, respectively.
  • the first spacer 6 and second spacer 8 together with the side spacers 28 form a circumferential spacer 30 arranged to abut against the face along its entire circumference. This provides the advantage of separating the entire viewing region 10 from the surroundings, and protecting the eyes from foreign objects.
  • the sheet 2 extends beyond the first spacer 6 such that it extends over the forehead region of the wearer.
  • the sheet 2 also extends beyond the second spacer 8 such that it extends over the nostrils 20 and mouth 24 of the wearer.
  • the sheet extends beyond the side spacers 28 over the left and right temple regions of the wearer, respectively.
  • the second spacer 8 is impermeable to vapor and forms a vapor barrier between on the one hand the nostrils 24 and mouth 26 and on the other hand the viewing region 10.
  • the first spacer 6 comprises a plurality of ventilation apertures 17 for providing ventilation to the viewing region 10.
  • the ventilation apertures 17 are covered by a covering 19.
  • the covering 19 is permeable to air, but forms a barrier against liquid droplets.
  • a portion of covering 19 has been removed for illustrative purposes only in order to expose apertures 17. It is possible that the first spacer 8 does not comprise ventilation apertures and that the side spacers 28 comprise ventilation apertures.
  • the second spacer 8 in the examples of Figures 1 - 3b can also be impermeable to vapor. It is for instance possible that the second spacer 8 includes, or is formed from, a closed cell foam. It will be appreciated that, similarly, also the first spacer in the examples of Figures 1 - 3b can include ventilation openings. For instance, the cutouts 12 in the example of Figure 2a can form ventilation openings. If desired also these ventilation cutouts can be covered by a covering to form a barrier against liquid droplets. It is also possible that the first spacer 6 is formed of an open cell foam so as to form the ventilation openings. The open cell foam can also provide impermeability to droplets of liquid.
  • the shield 1 also includes a strip 15 of super absorbent material arranged to catch, absorb, and/or hold liquid droplets and/or liquid splashes that land directly on the strip or slide from the sheet into the strip.
  • the strip 15 includes a super absorbent polymer and extends across the bottom of edge of sheet 2. It will be appreciated that this strip 15 can also be included in the embodiments of the face shield 1 described in view of Figures 1 - 3b.
  • the sheet may hold liquid droplets outside the viewing region 10. This provides the advantage that the droplets are preventing from running from the sheet 2 e.g. onto a patient.
  • the sheet 2 may be liquid repellent inside the viewing region 10. This provides the advantage that droplets hitting the sheet 2 will automatically disappear (e.g. slide) from the viewing region.
  • the liquid holding/repellent properties may be inherent to the sheet material and/or be obtained by means of a suitable coating to the sheet 2.
  • FIGS 5 and 6 depict two alternative embodiments of disposable surgical face shield 1, comprising a screen including a display 50. All of the technical features described with respect to figures 1-4 can be included in the disposable surgical face shields 1 of figures 5 and 6. The same reference numbers have been used to designate these corresponding features.
  • the control unit 40 is communicatively connected to a receiver 42. Instead of, or in addition to, the receiver 42, the control unit 40 can also be communicatively connected to a data storage unit 44.
  • the electrical contacts 38 are connected to the control unit 40 by a first cable 39, and the control unit 40 is connected to the receiver 42 by a second cable 41, and to the data storage unit 44 by a third cable 43. It is
  • the display 50 is attached by re-adherable adhesive on an inside of the face shield 1, e.g. the same side as the spacers. This prevents damage and/or contamination of the display 50.
  • the display 50 can be an active matrix OLED display.
  • Figure 5 shows the disposable surgical face shield 1, wherein a display 50 is included inside the viewing region 10.
  • Figure 5 is a rear view, or wearer view, of the shield 1.
  • the display 50 acts as a head-up display for the wearer.
  • some of the medical patient's vitals 52 such as heart rate and oxygen saturation (Sp02) are displayed.
  • Sp02 heart rate and oxygen saturation
  • Information representative of the vitals 52 is received by the receiver 42 and processed by the control unit 40 so as to be displayed on the display 50.
  • the shield 1 is depicted in a situation in which the wearer is viewing the medical patient's arm 54 through the shield 1, sheet 2, and display 50.
  • a previously acquired X-ray image of the arm is displayed on display 50 and thus bones 56 and 58 appear superimposed on the patient's arm 54 to the wearer.
  • Data relating to the X-ray image can be stored in the data storage unit 44, e.g. be
  • the receiver 42 receives the data relating to the X-ray image from a medical database, e.g. during the operation.
  • the control unit 40 is arranged to remove the X-ray image from the display and replace it with another image, such as an MRI image, e.g. of the same portion of the patient. This way the user can switch between different images, providing him with different types of information on the patient. Switching of the images may be controlled by a controller which is wirelessly or wiredly connected to the control unit 40.
  • the controller may be attached to the shield 1 and/or to the display 50.
  • the controller may also be a separate module, to be activated by the user or an assistant.
  • Figure 6 shows a disposable surgical face shield 1, wherein the display 50 is included outside the viewing region 10.
  • Figure 6 is a front view of shield 1.
  • the display 50 is arranged to be utilized by other medical professionals working along side the wearer.
  • an MRI image of the brain of the patient being treated is displayed on display 50 of shield 1.
  • control unit the processing unit, data storage unit and receiving unit can be embodied as dedicated electronic circuits, possibly including software code portions.
  • the control unit, processing unit, and receiving unit can also be embodied as software code portions executed on, and e.g. stored in a memory of, a programmable apparatus such as a computer.
  • the disposable surgical face shield including a flexible liquid-impermeable screen arranged to extend over at least part of the facial region of a wearer including the display, the control unit, the data storage unit and/or the receiving unit, and optionally the processing unit, not necessarily comprises the spacers as described hereinabove.
  • the 40 is provided with (or coupled to) a position sensor.
  • the position sensor is arranged to determine the position of the display relative to the patient.
  • the position sensor can also be arranged to determine the orientation of the display relative to the patient. Thereto the position sensor may e.g. make use of GPS, a gyro, or the like.
  • the control unit 40 is able to determine an overlay of a given (set of) medical imaging data, such as (3D) CAT or MRI data.
  • the overlay is determined such that the user sees, at the display 50 at the determined position and/or orientation, medical imaging data (an image) which is aligned with the view of the patient through the display at the determined position and/or orientation.
  • any reference signs placed between parentheses shall not be construed as limiting the claim.
  • the word 'comprising' does not exclude the presence of other features or steps than those listed in a claim.
  • the words 'a' and 'an' shall not be construed as limited to 'only one', but instead are used to mean 'at least one', and do not exclude a plurality.
  • the mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to advantage.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Textile Engineering (AREA)
  • Professional, Industrial, Or Sporting Protective Garments (AREA)

Abstract

La présente invention concerne un masque chirurgical jetable (1) comprenant une feuille flexible imperméable aux liquides et transparente au moins dans la région de visibilité (10), ledit masque étant disposé de manière à couvrir le front, les narines et la bouche du porteur. Le masque comprend un moyen de fixation (4) permettant de fixer le masque sur la tête du porteur, un premier élément d'écartement (6) fixé sur la feuille et disposé de manière à buter contre le visage du porteur, au dessus des yeux, et un second élément d'écartement (8) fixé sur la feuille et disposé (16, 18) de manière à buter contre l'arête nasale du porteur. Le second élément d'écartement est incliné de manière à ce que, lorsque le masque est fixé sur la tête du porteur, une zone proximale du second élément d'écartement proximal par rapport aux yeux du porteur soit positionnée à une hauteur plus élevée qu'une zone distale du second élément d'écartement distal par rapport aux yeux du porteur.
PCT/NL2013/050382 2013-05-24 2013-05-24 Masque chirurgical jetable Ceased WO2014189364A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/NL2013/050382 WO2014189364A1 (fr) 2013-05-24 2013-05-24 Masque chirurgical jetable

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/NL2013/050382 WO2014189364A1 (fr) 2013-05-24 2013-05-24 Masque chirurgical jetable

Publications (1)

Publication Number Publication Date
WO2014189364A1 true WO2014189364A1 (fr) 2014-11-27

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Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018057920A1 (fr) * 2016-09-23 2018-03-29 Pavalarajan Ganesh B Casque chirurgical
WO2019046434A1 (fr) * 2017-09-01 2019-03-07 ClearMask, LLC Masque facial ayant une pièce en plastique transparent
EP3469939A1 (fr) * 2017-10-13 2019-04-17 Honeywell International Inc. Mousse de polyoléfine recoupée comme joint de masque jetable
US10709911B2 (en) 2013-09-27 2020-07-14 Zimmer Surgical, Inc. Surgical helmet
CN111529201A (zh) * 2020-05-08 2020-08-14 嘉兴市第二医院 一种带面屏的防雾护目镜
GB2591870A (en) * 2019-12-19 2021-08-11 Batrik Medical Mfg Inc Face shields
IT202000010192A1 (it) * 2020-05-08 2021-11-08 Egidio Armando Mascherina protettiva con visiera accessoria, auto-reggente, auto-collassabile e non riutilizzabile dopo l'asportazione, usa e getta, biocompatibile, biodegradabile, compostabile, a protezione aumentata, economica, per l'utilizzo mirato da parte degli utenti di saloni di acconciatura, di bellezza, di estetica e simili, ed in genere durante le attivita' di durata breve e controllata, di cura della persona.
US20210368884A1 (en) * 2020-05-29 2021-12-02 Huanghua Promisee Dental Co., Ltd. Face shield
EP3922119A1 (fr) 2020-06-08 2021-12-15 Elastoni-Confecções, Lda Masque facial, son procédé de fabrication et ses utilisations
WO2022080047A1 (fr) * 2020-10-13 2022-04-21 デンカ株式会社 Écran facial
JP2022091055A (ja) * 2020-12-08 2022-06-20 株式会社プラムカンパニー 飛沫捕獲剤及びこれを用いた飛沫捕獲剤の使用
USD958324S1 (en) 2020-08-19 2022-07-19 Koller Enterprises, Inc. Clear face mask
US20220331624A1 (en) * 2021-04-15 2022-10-20 Fundacion Universidad Catolica De Valencia San Vicente Martir Facial protection element for protection against risks of exposure to infectious biological agents
US11547880B2 (en) * 2020-09-04 2023-01-10 Lewis Maurice Oliver, III Particle protection headwear apparatus
US20230140986A1 (en) * 2020-05-29 2023-05-11 Nrj Pro, Llc Systems and methods for aerosol protection shield

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CN201718520U (zh) 2010-04-27 2011-01-26 何金昌 防护面罩

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US2665686A (en) * 1952-03-17 1954-01-12 Edwin E Wood Face mask
US4296746A (en) * 1979-12-18 1981-10-27 Surgikos Disposable full-face surgical mask
US5446925A (en) * 1993-10-27 1995-09-05 Minnesota Mining And Manufacturing Company Adjustable face shield
US5440760A (en) 1994-02-04 1995-08-15 Tecnol Medical Products, Inc. Disposable face shield
US5584078A (en) * 1994-11-16 1996-12-17 Saboory; Majid Detachable/disposable face shield for surgical mask
US5666671A (en) * 1994-12-07 1997-09-16 Daneshvar; Yousef Facial mask
US6213125B1 (en) * 1998-04-30 2001-04-10 Kimberly-Clark Worldwide, Inc. Device for protecting the face of a wearer
CN201718520U (zh) 2010-04-27 2011-01-26 何金昌 防护面罩

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10709911B2 (en) 2013-09-27 2020-07-14 Zimmer Surgical, Inc. Surgical helmet
US11284655B2 (en) 2016-09-23 2022-03-29 Zimmer, Inc. Surgical helmet
US10687568B2 (en) 2016-09-23 2020-06-23 Zimmer, Inc. Surgical helmet
US11793250B2 (en) 2016-09-23 2023-10-24 Zimmer, Inc. Surgical helmet
WO2018057920A1 (fr) * 2016-09-23 2018-03-29 Pavalarajan Ganesh B Casque chirurgical
WO2019046434A1 (fr) * 2017-09-01 2019-03-07 ClearMask, LLC Masque facial ayant une pièce en plastique transparent
JP2020532666A (ja) * 2017-09-01 2020-11-12 クリアーマスク，エルエルシー 透明なプラスチック片を有するフェイスマスク
EP3469939A1 (fr) * 2017-10-13 2019-04-17 Honeywell International Inc. Mousse de polyoléfine recoupée comme joint de masque jetable
GB2591870A (en) * 2019-12-19 2021-08-11 Batrik Medical Mfg Inc Face shields
IT202000010192A1 (it) * 2020-05-08 2021-11-08 Egidio Armando Mascherina protettiva con visiera accessoria, auto-reggente, auto-collassabile e non riutilizzabile dopo l'asportazione, usa e getta, biocompatibile, biodegradabile, compostabile, a protezione aumentata, economica, per l'utilizzo mirato da parte degli utenti di saloni di acconciatura, di bellezza, di estetica e simili, ed in genere durante le attivita' di durata breve e controllata, di cura della persona.
CN111529201A (zh) * 2020-05-08 2020-08-14 嘉兴市第二医院 一种带面屏的防雾护目镜
US20210368884A1 (en) * 2020-05-29 2021-12-02 Huanghua Promisee Dental Co., Ltd. Face shield
US20230140986A1 (en) * 2020-05-29 2023-05-11 Nrj Pro, Llc Systems and methods for aerosol protection shield
EP3922119A1 (fr) 2020-06-08 2021-12-15 Elastoni-Confecções, Lda Masque facial, son procédé de fabrication et ses utilisations
USD958324S1 (en) 2020-08-19 2022-07-19 Koller Enterprises, Inc. Clear face mask
US11547880B2 (en) * 2020-09-04 2023-01-10 Lewis Maurice Oliver, III Particle protection headwear apparatus
WO2022080047A1 (fr) * 2020-10-13 2022-04-21 デンカ株式会社 Écran facial
JP2022091055A (ja) * 2020-12-08 2022-06-20 株式会社プラムカンパニー 飛沫捕獲剤及びこれを用いた飛沫捕獲剤の使用
US20220331624A1 (en) * 2021-04-15 2022-10-20 Fundacion Universidad Catolica De Valencia San Vicente Martir Facial protection element for protection against risks of exposure to infectious biological agents

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