WO2021207292A1 - Endotracheal intubation protection device - Google Patents

Abstract

Certain embodiments are directed to a liquid and ballistic droplet protection shield ("shield") is described that provides increased protection infective fluids during the intubation process.

Description

ENDOTRACHEAL INTUBATION PROTECTION DEVICE

PRIORITY PARAGRAPH

[0001] This application claims benefit of United States Provisional Application number 63/005,691 filed April 6, 2020, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] Certain embodiments are directed to the field of medicine and protective equipment for Health Care Workers (HCW). Particular embodiments are directed to protective procedural hoods.

[0003] A respiratory disease (Coronavirus Disease 2019 (COVID-19)) caused by a novel coronavirus (SARS-CoV-2) was detected in China and has now been detected internationally, including detection in the United States. On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization declared the outbreak a public health emergency of international concern (PHEIC). On January 31, 2020 a public health emergency (PHE) was declared for the United States. Processes that favor aerosolization of sputum in infected and potentially infected individuals represents a potential source of exposure to the virus and is representative of other known and as yet to be discovered agents. Data from Wuhan and Northern Italy indicate that at least 10% of reported positive COVID-19 cases require ICU involvement, many requiring urgent tracheal intubation for profound and sudden hypoxia. One of the highest risks of exposure involves direct contact with respiratory droplets during airway management primarily during intubation and extubation. Furthermore, inadequate personal protective equipment (PPE), improper use of PPE, and poor hand hygiene are potential factors that can lead to transmission to those attending the infected.

[0004] Laryngoscopy can be used to assist tracheal intubation and involves the insertion of a laryngoscope to facilitate the visualization of the vocal cords (the visualization phase of tracheal intubation). This is followed by the insertion of an endotracheal tube (ETT) through the vocal cords (glottis) and then downward into the trachea (referred to as the insertion and cannulation phases of tracheal intubation, respectively). Traditionally, direct laryngoscopy (DL) has been employed to expose the glottis so that operators can view it directly in order to insert an ETT. A metallic stylet is usually placed within the ETT to promote rigidity and malleability in order to ease insertion. The stylet is more rigid than the ETT and will maintain its shape under normal loading conditions. Occasionally, during DL operators a patient has anatomic features that make visualization of the vocal cords difficult or impossible. These circumstances, along with advances in fiber-optic and digital camera technology, have led to the development of video laryngoscopy (VL) which employs laryngoscopes with distal cameras or fiber-optic bundles. VL’s make viewing the glottic aperture easier despite occasional challenging anatomic conditions or lower operator laryngoscopy skill levels. Consequently, even novice operators can now almost always visualize the vocal cords in circumstances where it would have been previously difficult. DL and VL are both used in day-to-day tracheal intubation practice. The HCW performing the procedure is at an increased risk of exposure to potentially infective fluids and aerosols.

[0005] There remains a need for additional devices and equipment to better protect HCWs during the treatment and/or intubation process.

SUMMARY

[0006] One solution to the problem of protecting healthcare workers (HCW) while treating a patient with a communicable disease or protecting a patient susceptible to pathogens that can be transmitted by a HCW is a protective procedural hood that provides a barrier between a subject being treated and the HCW. In certain embodiments the procedural hood can comprise a collapsible frame that when expanded forms a procedural hood having a frame supporting at least a front wall, rear wall, two or more side walls, (e.g., at least a left side wall and a right side wall), a top wall or ceiling, and an at least a partially open to fully open bottom or floor. The procedural hood, when expanded, defines a three-dimensional procedural space (or volume) or containment area within the walls; and has one or more access points or access ports formed in one or more of the walls. The wall can be a panel comprised of a frame and material covering the frame forming the wall. The procedural hood when expanded is configured to be placed over and to contain a portion of a subject’s body, e.g., the chest, neck, and head of a subject. The procedural hood can be configured to collapse or fold for storage and transport. The collapsed hood can be a flat two- dimensional configuration, which can be further folded or a rolled. In particular aspects the collapsed configuration is a two-fold configuration where the open device is folded first along a diagonal to form a flat device and, optionally, the flat device is folded again along the centerline between walls to produce a folded or collapsed device. The hood can further comprise two pull tabs positioned in the top third of a wall edge and diagonal from each other when the hood is fully expanded, which can be pulled to assist in expanding the hood into an operable configuration. In certain aspects the pull tabs have a distinct coloration to be visually distinguishable from the body of the device, in certain instances the pull tabs can be red or another bright color. The pull tab can be made of nylon, cotton or any other material that can be grasped and pulled to assist in deployment. The device can be configured with a locking mechanism to retain the folded configuration until use, the locking mechanism can be a clip, loop and hook, snap, or other mechanism position on two walls that are non-adject when the hood is in an expanded configuration. When the locking mechanism in engaged the hood remains in a folded configuration. When the hood needs to be deployed the locking mechanism is disengaged and the hood expanded for use.

[0007] In certain aspects, the procedural hood dimensions (L x W x H) can be in the range of 300, 350, 400, 450, 500, 550, 600 mm or more in length (including all values and ranges there between); 300, 350, 400, 450, 500, 550, 600 mm or more in width (including all values and ranges there between); and 300, 350, 400, 450, 500, 550, 600, 650, 700 mm or more in height (including all values and ranges there between). In a particular embodiment the procedural hood dimensions (L x W x H) are 550 ± 25 mm long by 550 ± 25 mm wide by 610 ± 25 mm high. In a particular aspect the volume of the procedural hood 184.5 liters, and can range from 25 liters to 260 liters or more. The walls can be configured with gussets to form the top corners of the hood. The gussets can be configured to retain the seal at the comers of the hood.

[0008] In certain aspects the walls are a transparent thermoplastic film or other material that is transparent, flexible, tearing resistant, crease resistant, and wrinkle resistant. In certain instance the transparent thermoplastic film is a polyurethane film. The film can be 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, 0.019 to 0.020 inches in thickness. In certain embodiments the walls are thermoplastic polyurethane film, 0.004" thick, Shore 85A or another similar material.

[0009] The front wall can be configured with a drape to reduce gaps at the patient hood interface, in turn reducing suction requirements. In certain aspects the material of the front wall drapes like cloth to conform to the patient torso. The skirt or drape can be attached to 1, 2, 3, 4, or more bottom edges and is configured to conform to a subject’s body when positioned in the protective procedural hood. The skirt or drape can form a semicircular or other opening to receive a subject’s body and maintain the integrity of the containment within the hood. The skirt or drape can be weighted or have a weighted edge to secure or aid in fixing the skirt or drape about the subject’s body, bed, gurney, or other objects or surfaces when in use. In certain embodiments the skirt or drape is attached to all edges of the bottom wall.

[00010] The walls are formed by supporting the wall material with a frame and attaching each adjacent wall partially or fully along an edge formed by two adjacent walls. In certain aspects the frame is comprised of a springing material that flexes under force and returns to its original shape, i.e., it flexes during the folding procedure and can be returned to an expanded configuration upon unfolding or deployment. In certain aspects the frame material is stainless steel. In a particular aspects the stainless steel is a 140-165 kpsi (965 - 1138 MPa) 304 stainless steel or similar material. The frame arms can have a circular, oval, square, rectangular, tubular or flat wire (rectangle with rounded edges) cross-section. In certain embodiment the cross-section is 0.5, 0.6, 0.7, 0.8, 0.9 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5 x 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5 mm (including all values and ranges there between). In certain aspects the frame arms are 1.3 x 3.3 mm (0.053 x 0.130 inch) flat wire. The frame arms can be 300, 350, 400, 450, 500, 550, 600, 650, 700 mm in length, including all values there between. The term “ferrule” is a sleeve (metal or plastic) used to join or bind one frame arm to 1, 2, 3 or more other frame arms, the ferrule having an inner diameter configured to fit the outer diameter of the frame arm. In certain aspects the ferrule can be 24 GA stainless steel. In certain aspects the ferrule is 10, 15, 20, 25, 30, 35, to 40 mm in length, including all values there between.

[00011] In certain aspects the walls are a flexible plastic. One or more (1, 2, 3, 4, 5, or more) of the walls can be transparent, translucent, or opaque. In particular embodiments, at least on wall is transparent to allow visualization of the containment area and subject. In come aspects all walls are transparent. The protective procedural hood, when in an expanded configuration, can form a quadrilateral cube. In certain aspects, the quadrilateral cube is a rhombus, square, or rectangular cube. [00012] The procedural hood can include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more access points. The access point can be configured as gas supply port(s), vacuum port(s), personnel access ports (e.g., hands and arms), or instrument access ports. In certain aspects, the access points can be secured by hook and loop, zipper, adhesive, a reversible fastener and the like to keep the access point closed until needed. In other aspects the access point can be sealed and configured as an integrated glove(s), or port. The ports can be openings in the wall that are covered to maintain as much of a seal to the procedural space as possible. The opening can be covered by a fabric panel. The fabric panel in constructed to allow a hand, arm, and/or instrument(s) to be inserted or removed from the procedural space. In certain aspect the fabric panel can be an 80% polyester/20% spandex with 4- way stretch fabric. The fabric panels can be attached to the portion of the wall forming the access hole by a trim. In certain aspects the trim is a cotton twill bias tape, or equivalent trim material. In certain aspects the wall to form an opening of 100, 125, 150, 200, 210, 220, 230, 240, 250, 300 mm or more in diameter. In certain aspects the opening is about 250 mm or 9 inches in diameter or maximum. The opening can be any particular geometry, including circles, squares, rectangles or any other regular or irregular polygon. In certain aspects the opening is circular, which can help in optimizing the manufacturing process. In certain aspects the opening form by the wall is covered by two or more fabric panels, with the panels having an overlap. In certain aspects the overlap is along the centerline of the opening. The overlap can be 15, 20, 25, 30, 35, mm or more. In certain aspects the fabric panel includes a bias cut (45° to fabric grain), which allows the fabric to stretch much more without rolling/sagging versus cutting parallel or perpendicular the grain. In particular aspects access point for the operators can include 2 vertical, overlapping panels. This configuration can accommodate a high range of operator movement and is easy to manufacture. In other aspects the fabric panel can be a double-layer panels (i.e., folded along free edge rather than hemmed).

[00013] The access point for a gas supply or vacuum can be coupled to one or more filters. The gas and/or vacuum being provided by a conduit, tube, or other closed pathway. In certain aspects a vacuum port or suction port is provided in at least one wall of the hood. The port can be a flexible PVC port. In particular a Reinier Plastic RM 12590D CLEAR 100 vacuum port. In certain aspects, the vacuum port is configured to fit a standard, 22 mm respiratory tubing. In certain embodiments a vacuum port is position in the front wall above a drape. Placement of the vacuum port in top third of the wall ensures that bedding, patient clothing, etc can't occlude the opening. A front wall location can provide a configuration that allows one to support the vacuum port while connecting the appropriate tubing.

[00014] In certain aspects, a vacuum is applied via a vacuum port. In certain aspects, the vacuum port is positioned in the front wall. In certain aspects the vacuum port is positioned in the top third vertically of the front wall. In other embodiments the vacuum port is positioned in the middle third horizontally and the top third vertically of the front wall. The vacuum port can be configured to be compatible with standard vacuum sources used by hospitals or compatible with portable vacuum sources. In certain aspects, a vacuum of 20 to 200 L/min low flow suction rate can be applied. In certain aspects the vacuum applied results in a 4, 5, 6, 7, 8, 9, 10 minute volume turnover (including all values and ranges there between. In certain aspects the vacuum applied results in a 5 to 7 minute volume turnover. In certain embodiments the vacuum port is configured to couple to respiratory tubing. In certain aspects the respiratory tubing is 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 mm tubing, wherein the respiratory tubing is also coupled to a vacuum source.

[00015] Vacuum / Suction port can have an adapter made from metal or plastic. Flexible PVC, Reinier Plastic RM 12590D CLEAR 100. All bag ports we've found are made of this sort of flexible PVC. Vacuum port can be configured to couple to 22 mm respiratory tubing, e.g., 22 mm polypropylene, expandable respiratory tubing. In certain aspects the tubing can have an inner diameter of 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, or 30 mm x 300, 400, 500, 600, 700, 800, 10,000 mm in length. In certain aspects the tubing is expandable/collapsible along its length which provides adaptability to routing of the tubing.

[00016] The tubing can be coupled to a filter. The filter can be integrated into the tubing or coupled via the appropriate adapter. In certain aspects the filter is an anti-microbial filter, e.g., an OTS bacterial/viral filter.

[00017] Some advantages that can be realized with the procedural hood described herein include: (i) the mitigation of operator exposure to droplets and aerosols; (ii) simple and rapid deployment; (iii) multiple access portals enable assistance with procedures; (iv) connects to standard wall suction; (v) material and design provide improved visibility; (vi) access portals permit exceptional operator range of motion; (vii) single use device eliminates the need for cleaning and sterilization; (viii) Lightweight and foldable for easy storage, transport, and disposal; and/or (ix) clips provide secure attachment to patient bed.

[00018] A liquid and ballistic droplet protection shield (“shield”) is described that provides increased protection against infective fluids during the intubation process. The shield described herein can be made out of a plastic material. In certain aspects, the plastic is transparent. The shield can be of a rigid thickness, as thin as a disposable water bottle, (sub mm) or as thin as plastic shielding found in disposable medical face masks making it easy to deflect and move out of the way by an operator’s hand or to be folded in packaging (0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, to 5.0 mm including all values and ranges there between). The shield can be constructed out of or be coated with an antifog polymer to maintain visibility through the shield during a procedure. If placed onto an endotracheal tube (ETT), it could secure to the ETT. In certain aspects, the shield can be secured or attached to the shaft of the ETT or other portion of an intubation device with expandable clip. A clip connector can be ETT external diameter specific or it could accommodate a range of ETT external diameters by means of an expandable clip (FIG. 1) or a foam-lined clip. It could also connect to the standard 11 mm connector of the ETT.

[00019] Certain embodiments are directed to a protective shield to be attached to an ETT tube or a tracheal cannulation device to protect caretakers during the intubation process. In certain aspect the shield has a top surface facing the caretaker that is intubating a patient and a bottom surface that faces the patient. The shield can include or form a notch to accept a portion of an ETT or a tracheal cannulation device so as to position a portion of the shield around a portion of the circumference of the tracheal cannulation device, i.e., the ETT or tracheal intubation device project through a portion of the shield during use. In certain aspects, the shield has a regular (e.g., circle, oval, square, rectangle pentagon, hexagon, etc.) or irregular shape. In certain aspects the shield is circular, oval, or rectangular. The shield can be a portion of a circle having a circumference with an arc of 90 degrees to 340 degrees, including all arcs there between. The shield can have a thickness of 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75 to 2 mm, including all values and ranges there between. The shield can be at least 10, 15, 20, 25, 30, 35, 40, 45, to 50 cm, including all values and ranges there between, in its longest dimension and can have a second dimension of between 10, 15, 20, 25, 30, 35, 40, 45, to 50 cm, including all values and ranges there between, independent of the first dimension. The shield can be substantially flat. Substantially flat refers to some tolerance for bend in the shield with potential for a molded or design curvature of 1 to 10 degrees. The shield can be made of material that flexes yet maintains a flat or substantially flat configuration. The shield physically blocks any aerosolized or projected body fluid from reaching the HCW intubating the patient. In certain aspects, the planar surface of the shield is to be positioned substantially perpendicular (with in 80, 85, 90, 95, 100 degree angle between the plane of the shield and the long access of the intubation device) to the long axis of the ETT or tracheal cannulation device during use. The shield will incorporate a connector to attach (permanently or reversibly) to the ETT or tracheal cannulation device.

[00020] The shield can include a connector that is configured to allow attachment and/or detachment (reversibly attached) of the shield to an ETT or tracheal intubation device. In certain aspects, the tracheal cannulation device includes a video laryngoscope. In certain aspects, the connector is a one or two component connector. A two piece connector can include a first component that is affixed to the ETT or tracheal cannulation device and a second component included in the shield assembly (e.g., loop and hook (Velcro®) type of connector. The second connector component of the shield assembly complements the first connector component and is configured to secure the shield in a protective position. In certain aspects, a connector is disposed on the outer edge of the shield or is centrally disposed and accessible via notch in the shield. In certain aspects, the notch can be formed in the shield or can be a slice in the shield that can be opened to move around a device and closed once the device is in position. The connector can be configured as a snap-on, clamp, thread/bolt, adhesive, hook and loop (e.g., Velcro®), magnetic, or other type of connector or connector component pair, including various combinations thereof.

[00021] In one aspect, the connector can be a snap-on type of connector having a generally circular shape with a wall forming a connector opening along the width of the connector wall, a top opening having a plane parallel with the shield and a bottom opening having a plane parallel with the shield, and the connector opening of the connector has a dimension that is less than a diameter of the device to which the shield will be attached. The dimension of the opening of the connector is expandable in response to the insertion of a portion of the body of device to which it is being attached. [00022] In other embodiments the shield described herein can be incorporated into a sterile cover or kit or packaging.

[00023] Other embodiments of the invention are discussed throughout this application. Any embodiment discussed with respect to one aspect of the invention applies to other aspects of the invention as well and vice versa. Each embodiment described herein is understood to be embodiments of the invention that are applicable to all aspects of the invention. It is contemplated that any embodiment discussed herein can be implemented with respect to any method or composition of the invention, and vice versa. Furthermore, compositions and kits of the invention can be used to achieve methods of the invention.

[00024] The use of the word "a" or "an" when used in conjunction with the term "comprising" in the claims and/or the specification may mean "one," but it is also consistent with the meaning of "one or more," "at least one," and "one or more than one."

[00025] Throughout this application, the term "about" is used to indicate that a value includes the standard deviation of error for the device or method being employed to determine the value.

[00026] The use of the term "or" in the claims is used to mean "and/or" unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and "and/or."

[00027] As used in this specification and claim(s), the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") are inclusive or open- ended and do not exclude additional, unrecited elements or method steps.

[00028] Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. DESCRIPTION OF THE DRAWINGS

[00029] The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of the specification embodiments presented herein.

[00030] FIG. 1 A- ID. (A) Perspective illustration of an aerosol mitigating procedural hood from a front perspective. (B) Perspective illustration of an aerosol mitigating procedural hood from a back perspective. (C) Illustration of a procedural hood attached to a litter via attachment straps and a litter adapter. (D) Illustrates a procedural hood configured with attachments for both bed attachment (clips) and litter attachment (circular clips).

[00031] FIG. 2A-2C. Illustration of one example of panel patterns for construction of one embodiment of a procedural hood. (A) A front panel with drape. (B) A top panel with gussets. (C) A side panel with access ports.

[00032] FIG. 3A-3H. Illustration of examples of procedural hoods. (A) One example of an embodiment expanded for use with vacuum tube attached. (B) Illustration of one embodiment positioned for use on a mannequin. (C) front view of one embodiment of a frame and shroud procedural hood. (D) Bottom view of a frame and shroud procedural hood. (E) Illustration of one embodiment of a frame and shroud for a procedural hood. (F) Illustration of a fully assembled frame and shroud procedural hood. (G) A back view of a frame and shroud procedural hood comprising two access ports. (H) A side view of a frame and shroud procedural hood having an access port and a vacuum port.

[00033] FIG. 4A-4C. Illustration of the mechanism for expanding a folded procedural hood. (A) A folded hood with all four side walls stacked. (B) Illustrates the opening of the folded hood by moving pairs of adjacent side walls away from one another. (C) Illustrates expansion of the hood for use by pulling the pull tabs exposed by the first unfolding away from one another separating the hood at a diagonal and forming a procedural space with the walls of the hood. The folding process would be the reverse of the unfolding process. [00034] FIG. 5. Illustrates a vacuum tube configuration, (A) exploded view and (B) an assemble view.

[00035] FIG. 6A-6E. Illustrations of various configuration of port coverings to limit ingress and egress from the procedural space while providing access to the procedural space. (A) Two panel circular. (B) Two panel rectangular. (C) A second two panel circular. (D) Three panel circular. (E) Four panel circular.

[00036] FIG. 7. Time series graph (30-minute experimental time course) of the STAT Enclosure device tested with suction, showing the time dependent clearance of aerosol particles, with measurements taken inside and outside the enclosure. Time points are median total airborne particle counts, all sizes, for the experiments run in triplicate. The inset image shows the graph with the range of total particle counts (y-axis) maximized at 10000.

[00037] FIG. 8. Time series graph of the STAT Enclosure device tested with suction, and the control, tested over 360 sec experimental time-course. Time points are median total airborne particle counts, all sizes, for the experiments run in triplicate. The inset image shows the graph with the range of total particle counts (y-axis) maximized at 5000.

[00038] FIG. 9. Illustration of a liquid and ballistic droplet protection shield connected to endotracheal tube by means of an expandable plastic clip.

[00039] FIG. 10. Illustration of a liquid and ballistic droplet protection shield connected to the “Tusk Stylet” at a specific clip-on attachment point.

[00040] FIG. 11. Illustration of a liquid and ballistic droplet protection shield connected to a video laryngoscope by means of an adhesive tab.

DESCRIPTION

[00041] While performing endotracheal intubation (ETI) health care workers (HCWs) are in close proximity to the patient’s airway subjecting them to potential splash exposure to blood, vomitus, secretions, droplets, and aerosols which may contain potential pathogens. For example, ETI is known to present a distinctly higher risk of transmission of acute respiratory infection to health care workers in patients with coronavirus relative to other medical procedures such bronchoscopy, nasogastric tube insertion, or sputum collection.

[00042] Common personal protective equipment (PPE) utilized by HCWs during routine ETI includes gloves and sometimes eye protection. For isolation patients (e.g., those with drug-resistant infections such as methicillin resistant Staphylococcus aureus (MRSA)) HCWs also wear a gown in order to reduce or prevent contact transmission to other patients. As the risk to HCWs escalates, the recommended PPE increases. For example, the PPE recommendations for high-risk respiratory virus patients, such as those cared for during the COVID-19 pandemic, includes eye protection (possibly a face shield), an N-95 mask, a waterproof gown, a head cover, shoe covers, and a viral/bacterial filter for mask and endotracheal ventilation.

[00043] The recommendations for ETI for coronavirus patients also include using video laryngoscopy (as opposed to direct laryngoscopy) for vocal cord visualization in order to limit operator proximity to the airway during the procedure. As above, ETI can be one of the highest risk procedures for HCWs depending upon the transmissible organism, so factors that can mitigate their exposure to fluids, droplets, and aerosols are beneficial in decreasing HCW risk.

[00044] Certain embodiments of a device described herein aims to mitigate HCW exposure to fluids and ballistic particles (e.g., large droplets) during ETI.

I. Procedural Hood

[00045] Certain embodiments are directed to a procedural hood to mitigate HCW exposure to aerosolized pathogens. As described above, the COVID-19 crisis has prompted a call to mitigate risks to health care workers (HCWs), especially during endotracheal intubation (ETI) and other aerosol generating procedures (Meng et al. URL anesthesiology. pubs. asahq.org/article. aspx?articleid=2763453). ETI in itself can be frightening for many providers. Now that it is potentially deadly, the procedural stress is deeply magnified. A simple and effective procedural shield/hood technology can mitigate HCW exposure to ballistic droplets and aerosols during ETI, tracheal extubation, and other aerosol generating procedures thus decreasing infectious risk. It would also be invaluable in decreasing HCW stress. [00046] Uses for a procedural hood described herein include ETI, extubation, bronchoscopy, and can be used in on-site, in ambulance, hospital, operating room (OR), transport beds and like. The procedural hoods can provide (1) an increased level of protection to HCW’s during the conduct of droplet and aerosol generating procedures, particularly ETI and extubation, (2) a functional workspace (e.g., a negative pressure local environment), (3) disposability, and (4) less provider stress.

[00047] The procedural hood (“hood”) can be used in an open or expanded configuration. The hood forming a procedural space. The hood having a base formed by horizontal supports and a top formed by horizontal supports, and walls formed by separating the bottom and top with vertical supports. In the case of rectangular hood (see one embodiment FIG. 1A-1B and a second embodiment FIG. 3C-3E), the hood having a left wall 111, 311, a right wall 113, 313, a rear wall 112, 312, a front wall 110, 310, and an optional bottom or partial bottom 343. The rear wall facing away from a subject’s body when in use and the front wall facing the remainder of the subject’s body that is not covered by the hood. The front wall can include a flexible skirt or drape (e.g., see FIG. 3). The flexible skirt/drape 115, 315 in the front wall 110, 310 can be rhomboid, square, semicircular, or any polygon in shape. One or more of the left wall 111, 311; right wall 113, 313; front wall 110, 310; rear wall 112, 312; and top or roof 114, 314 being formed of a transparent, flexible material. FIG. 3E illustrates one embodiment of frame 323 that can be inserted into a flexible hood to provide support and maintain the procedural space. When not in use the frame can be folded. The illustration in FIG. 3E shows the frame with the walls removed except for a partial floor 343. In certain aspects the rear wall and the top or roof of the hood is transparent. The bottom of the hood is partially or fully open to receive all or a part of a subject’s body. In certain aspects, the upper portion of a subject (including the head and neck, and can extend to mid-chest or waist) is to be covered by the hood. The perimeter or a portion of the perimeter of the bottom can be attached to a skirt/drape that can drape over subject or the surface supporting the subject on which the hood is deployed. The skirt can drop from all four bottom edges. In certain aspects, the bottom of the skirt/drape can be weighted to assist in maintaining the position of the skirt/drape.

[00048] FIG. 1 illustrates an example of one embodiment. In certain embodiments the procedural hood can comprise a collapsible frame 123 that when expanded forms a procedural hood having a frame 123 supporting at least a front wall 110, rear wall 112, two or more side walls 111 and 113, (e.g., at least a left sidewall and a right sidewall), a top wall, roof, or ceiling 114, and an at least a partially open to fully open bottom or floor. FIG 2 illustrates examples of the patterns for front wall 110 (FIG. 2 A), top wall 114 with corner gussetts (FIG. 2B), and a side wall 111, 113 and back wall 112 (FIG. 2C). These patterns can be altered in various ways, e.g., geometry, drape length and shape, presence or absence of port in back wall or one side wall, etc.

[00049] The hood can have body walls and a top of transparent material, the top and the walls forming the procedural space therein. In certain aspects, the bottom is at least partially open or open to receive a portion of a subject’s body to be covered by or within the procedural space. In certain aspects the hood can have 3, 4, 5, or more body walls extending form the bottom to the top of the hood. The intersection of the top and two walls forms a top corner. The intersection of the top and one wall forms a top edge. In certain aspects there can be 3, 4, 5 or more top comers. In a particular aspect, there are a first, second, third, and fourth top corners with corresponding first, second, third and fourth bottom comers, this particular embodiment forming a quadrilateral (e.g., square, rhombus, or rectangular) cube of procedural space. In certain aspects, the walls are supported by vertical and horizontal supports or frame (e.g., rods, wires, tubes, or poles). The supports or the configuration of support attachment have sufficient flexibility to fold into a collapsed configuration for storage and transport. The horizontal supports can be 300, 350, 400, 450, 500, 550, 600, 650, 700 mm in length (including all values and ranges there between) or 15, 20, 21, 22, 23, 24, 25, to 30 inches or more when assembled, including all values and ranges there between. The vertical supports can be 300, 350, 400, 450, 500, 550, 600, 650, 700 mm or more in height (including all values and ranges there between) or 15, 20, 21, 22, 23, 24, 25, to 30 inches or more when assembled, including all values and ranges there between. The vertical supports having one end secured, for example, to a first top corner and its opposite end secured to a corresponding first bottom corner. The support can be position in the lumen of connecting material and the connecting material of two walls are attached at the appropriate location to form an edge. A horizontal support can have one end secured to a first top corner and its opposite end secured to a second adjacent top corner, where the vertical support and horizontal support form a top angle. A horizontal support can have one end secured to a first bottom corner and its opposite end secured to a second adjacent bottom corner, where the vertical support and horizontal support form a bottom angle. The angle of formed by the vertical support with respect to the horizontal support can be 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, to 135, with the top and bottom angle totaling 180 degrees.

[00050] In certain embodiments, each corner can have three couplings to receive one vertical support and two horizontal supports. In certain aspects, the coupling has a reversible lock to stabilize or lock the position of the supports with respect to each other. Each support (horizontal and/or vertical) maybe one piece or multiple pieces/segments that can be coupled. The couplings can be locked to hold the hood body in an expanded and/or collapsed condition. In other embodiments, the corners are comprised of fabric gussets with the wall to wall attachment being along the edges of the walls. The supports can be collapsed under tension so that once released they will automatically move to a less tensioned condition (i.e., deploy to a functional configuration) and thereby automatically expanding the hood body where the hood can then be locked in an expanded (functional) state, in certain aspects the inherent tension in the supports maintains an expanded configuration. Once there is no use for the hood it can be collapsed and sterilized or discarded.

[00051] In certain aspects, each comer of the hood body can have a direct connection (supports are welded, sewn, or otherwise permanently connected), pocket, sleeve, pin, hollow, or hinge for receiving the end of support. One or more horizontal support, vertical support, or horizontal and vertical support can have two or more portions or segments that can be coupled or uncoupled. In some instances one or more horizontal support, vertical support, or horizontal and vertical support can have a lockable hinge or a reversible connection along its length to aide in collapsing or assembling the hood. In certain aspect the support portions may be connected or held together by a flexible ligament, such as an elastic cord running the length of the support. The supports can be attached to the wall material or can provide a frame for a material shroud to placed over the frame.

[00052] Referring to FIG. 1 and FIG. 3, the procedural hood, when expanded, defines a three- dimensional procedural space (or volume) or containment area within the walls (e.g., FIG. 3B); and has one or more access points or access ports 118, 318 formed in one or more of the walls, 111, 311; 112, 312; and/or 113, 313. The wall can be a panel comprised of a frame and material covering the frame forming the wall. The frames are attached to each other and form at least four vertical edges and four horizontal edges around the top wall 114, 314. The procedural hood when expanded is configured to be placed over and to contain a portion of a subject’s body (e.g., FIG. 3B), such as the chest, neck, and head of a subject.

[00053] The hood may be erected quickly and automatically, by releasing a latch(es) and/or unfolding and pulling pull-tabs; or it may be manually assembled by unfolding a frame, or connecting and locking support/support connections. When not in use the hood can be quickly collapsed (e.g., folded) and latched into a substantially flat configuration and can be readily stored. With reference to FIG. 4, the procedural hood can be configured to collapse or fold for storage and transport (see FIG. 4A-4C). The collapsed hood can be a flat two-dimensional configuration (FIG. 4B), which can be further folded or a rolled (FIG. 4A). In particular aspects, the collapsed configuration is a two-fold configuration (FIG. 4A) where the open device is folded first along a diagonal to form a flat device (FIG. 4B) and, optionally, the flat device is folded again along the centerline between walls to produce a folded or collapsed device (FIG. 4A). The hood can further comprise two pull tabs 419 positioned in the top third of a wall edge and diagonal from each other when the hood is fully expanded (FIG. 4C), the pull tabs can be pulled to assist in expanding the hood into an operable configuration (FIG. 4C). In certain aspects the pull tabs have a distinct coloration to be visually distinguishable from the body of the device, in certain instances the pull tabs can be red or another bright color. The pull tab can be made of nylon, cotton or any other material that can be grasped and pulled to assist in deployment. The device can be configured with a locking mechanism to retain the folded configuration of FIG. 4A until use, The locking mechanism can be a clip, loop and hook, snap, or other mechanism position on two walls that are non-adject when the hood is in an expanded configuration. When the locking mechanism in engaged the hood remains in a folded configuration. When the hood needs to be deployed the locking mechanism is disengaged and the hood expanded for use. The procedural hood can include attachment 421 in the bottom third of a wall to secure the hood to a surface such as a bed, litter, etc. The attachment can be a clip to fasten to bedding, hook to fasten to a rail or frame, or the like. The attachment can be coupled to the hood by a tether, the tether being a fixed length or stretchable.

[00054] In certain aspects, the procedural hood dimensions (L x W x H) can be in the range of 300, 350, 400, 450, 500, 550, 600 mm or more in length (including all values and ranges there between); 300, 350, 400, 450, 500, 550, 600 mm or more in width (including all values and ranges there between); and 300, 350, 400, 450, 500, 550, 600, 650, 700 mm or more in height (including all values and ranges there between). In a particular embodiment the procedural hood dimensions (L x W x H) are 550 ± 25 mm long by 550 ± 25 mm wide by 610 ± 25 mm high. In a particular aspect the volume of the procedural hood 184.5 liters, and can range from 25 liters to 260 liters or more. The walls can be configured with gussets to form the top corners of the hood. The gussets can be configured to retain the seal at the comers of the hood.

[00055] In certain aspects the walls are a transparent material. The wall material can be rubber or thermoplastic film, or other material that is transparent, flexible, tearing resistant, crease resistant, and wrinkle resistant. Examples of thermoplastics include without limitation organic thermoplastic or thermosetting polymers such as polyolefins, polyamides, polyesters, polystyrenes, polyurethanes, etc. In certain instance the transparent thermoplastic film is a polyurethane film. The film can be 0.001, 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, 0.016, 0.017, 0.018, 0.019 0.020, 0.030, 0.040, to 0.050 inches in thickness. In certain embodiments the walls are thermoplastic polyurethane film, 0.004" thick, Shore 85A or another similar material. The wall material may be formed of any suitable plastic materials, for example, polyolefins, and in particular members of the polyethylene family such as LLDPE, VLDPE, HDPE, LDPE, ethylene vinyl ester copolymer or ethylene alkyl acrylate copolymer, polypropylenes, ethylene-propylene copolymers, ionomers, polybutylenes, alpha- olefin polymers, polyamides, nylons, polystyrenes, styrenic copolymers e.g. styrene-butadiene copolymer, polyesters, polyurethanes, polyacrylamides, anhydride-modified polymers, acrylate- modified polymers, polylactic acid polymers, cyclic olefin copolymers, or various blends of two or more of these materials. As used herein, the term “rubber” includes any of a number of natural or synthetic high polymers having suitable properties of deformation (elongation or yield under stress) and elastic recovery. Hawley's Condensed Chemical Dictionary, pp. 1016-1018, 11th Ed. (1987). As used herein, the term “rubber” is not restricted to original natural rubber, but also to any material having mechanical properties substantially similar to those of natural rubber, regardless of its chemical constitution. As used herein, the term “elastomer” or “elastomeric” includes synthetic materials having rubber-like properties. A rubber is any polymer or composition of polymers consistent with the ASTM D1566 definition: “a material that is capable of recovering from large deformations, and can be, or already is, modified to a state in which it is essentially insoluble (but can swell) in boiling solvent.” [00056] The front wall, and/or side and back walls can be configured with a drape or skirt 115, 315 to reduce gaps at the patient hood interface, in turn reducing suction requirements. In certain aspects the material of the front wall drapes like cloth. The skirt or drape can be attached to 1, 2, 3, 4, or more bottom edges and providing additional seal to the protective procedural hood. The skirt or drape can form a semicircular or other opening to receive a subject’s body and maintain the integrity of the containment within the hood. The skirt or drape can be weighted or have a weighted edge to secure or aid in fixing the skirt or drape about the subject’s body, bed, litter, gurney, or other objects or surfaces when in use. In certain embodiments the skirt or drape is attached to all edges of the bottom wall.

[00057] The walls are formed by supporting the wall material with a frame and attaching each adjacent wall partially or fully along an edge or a comer formed by two adjacent walls. In certain aspects the frame is comprised of a springing material that flexes under force and returns to its original shape, i.e., it flexes during the folding procedure and can be returned to an expanded configuration upon unfolding or deployment. In certain aspects the frame material is stainless steel. In a particular aspects, the stainless steel is a 140-165 kpsi (965 - 1138 MPa) 304 stainless steel or similar material. The frame arms can have a circular, oval, square, rectangular, tubular or flat wire (rectangle with rounded edges) cross-section. In certain embodiment the cross-section is 0.5, 0.6, 0.7, 0.8, 0.9 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5 x 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5 mm (including all values and ranges there between). In certain aspects the frame arms are 1.3 x 3.3 mm (0.053 x 0.130 inch) flat wire. The frame arms can be 300, 350, 400, 450, 500, 550, 600, 650, 700 mm in length, including all values there between. The frame arms can be connected to one or more ferrules. The term “ferrule” is a sleeve (metal or plastic) used to join or bind one frame arm to 1, 2, 3 or more other frame arms, the ferrule having an inner diameter configured to fit the outer diameter of the frame arm. In certain aspects the ferrule can be 24 GA stainless steel. In certain aspects the ferrule is 10, 15, 20, 25, 30, 35, to 40 mm in length, including all values there between.

[00058] In certain aspects the walls are a flexible material, e.g., rubber or plastic. One or more (1, 2, 3, 4, 5, or more) of the walls can be transparent, translucent, or opaque. In particular embodiments, at least one wall, particularly the top wall or ceiling, is transparent to allow visualization of the containment area and subject. In some aspects all walls are transparent. The protective procedural hood, when in an expanded configuration, can form a quadrilateral cube. In certain aspects, the quadrilateral cube is a rhombus, square, or rectangular cube.

[00059] The procedural hood can include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more access points. The access point can be configured as gas supply port(s), vacuum port(s), personnel access ports 118 (e.g., hands and arms), or instrument access ports. In certain aspects, the access points can be secured by hook and loop, zipper, adhesive, a reversible fastener and the like to keep the access point closed until needed. In other aspects the access point can be sealed and configured as an integrated glove(s), or port. The ports can be openings in the wall that are covered to maintain as much of a seal to the procedural space as possible. The opening can be covered by a fabric panel (FIG. 6A-6E). The fabric panel is constructed to allow a hand, arm, and/or instrument(s) to be inserted or removed from the procedural space. In certain aspect the fabric panel can be an 80% polyester/20% spandex with 4-way stretch fabric. The fabric panels can be attached to the portion of the wall forming the access hole by a trim 117. In certain aspects the trim is a cotton twill bias tape, or equivalent trim material. In certain aspects the wall to form an opening of 100, 125, 150, 200, 210, 220, 230, 240, 250, 300 mm or more in diameter. In certain aspects the opening is about 250 mm or 9 inches in diameter or maximum dimension. The opening can be any particular geometry, including circles, squares, rectangles or any other regular or irregular polygon. In certain aspects the opening is circular, which can help in optimizing the manufacturing process. In certain aspects the opening form by the wall is covered by two or more fabric panels 118, with the panels having a fabric overlap 122. In certain aspects the overlap is along the centerline of the opening. The overlap can be 15, 20, 25, 30, 35, mm or more. In certain aspects the fabric panel includes a bias cut (45° to fabric grain), which allows the fabric to stretch much more without rolling/sagging versus cutting parallel or perpendicular the grain. In particular aspects access point for the operators can include 2 vertical, overlapping panels (FIG. 6A-6C). This configuration can accommodate a high range of operator movement and is easy to manufacture. In other aspects the fabric panel can be a double-layer panels (i.e., folded along free edge rather than hemmed). One or more wall can have 1, 2, 3 or more access ports. In certain aspects, 1, 2, or 3 walls have 2 or more access ports. In other embodiments, 1, 2, 3, or 4 walls have at least 1 or 2 access ports configured for HCW access to a subject in the procedural hood. [00060] The access point for a gas supply or vacuum can be coupled to one or more filters 552 as well as one or more gas or vacuum sources. In certain aspects, the vacuum source is a wall suction source, such as those sources provided in hospitals and the like. Other vacuum sources can be pumps and blowers, either fixed or portable. The gas and/or vacuum can be provided by a conduit, tube, or other closed pathway 550 attached to a gas or vacuum port of the procedural hood. In certain aspects a vacuum port or suction port 116, 316, 416 is provided in at least one wall of the hood, e.g., front wall 110, 310, 410. The port can be a flexible PVC port. In particular a Reinier Plastic RM 12590D CLEAR 100 vacuum port. In certain aspects, the vacuum port is configured to fit a standard, 22 mm respiratory tubing 550. In certain embodiments a vacuum port is position in the front wall above a drape. Placement of the vacuum port in top third of the wall ensures that bedding, patient clothing, etc cannot occlude the opening. A front wall location can provide a configuration that allows one to support the vacuum port while connecting the appropriate tubing.

[00061] In certain aspects, a vacuum is applied via a vacuum port. In certain aspects, the vacuum port is positioned in the front wall. In certain aspects the vacuum port is positioned in the top third vertically of the front wall. In other embodiments the vacuum port is positioned in the middle third horizontally and the top third vertically of the front wall. The vacuum port can be configured to be compatible with standard vacuum sources used by hospitals or compatible with portable vacuum sources. In certain aspects, a vacuum of 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, to 200 L/min low flow suction rate can be applied. In certain aspects the vacuum applied results in a 4, 5, 6, 7, 8, 9, 10 minute or more volume turnover (including all values and ranges there between). In certain aspects the vacuum applied results in a 5 to 7 minute volume turnover. In certain embodiments the vacuum port is configured to couple to respiratory tubing 550 or equivalent conduit. In certain aspects the respiratory tubing is 10, 11, 12, 13, 14, 15, 16, 17, 18,19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 mm tubing, wherein the respiratory tubing is also coupled to a vacuum source.

[00062] Vacuum / Suction port can have adapter made from metal or plastic. Flexible PVC, Reinier Plastic RM 12590D CLEAR 100. Ports to be connected to tubing can be flexible PVC ports. A vacuum port can be configured to couple to 22 mm respiratory tubing, e.g., 22 mm polypropylene, expandable respiratory tubing. In certain aspects the tubing can have an inner diameter of 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, or 30 mm x 300, 400, 500, 600, 700, 800, 10,000 mm in length. In certain aspects the tubing is expandable/collapsible along its length which provides adaptability to routing of the tubing.

[00063] The tubing can be coupled to a filter 551, FIG. 5. The filter can be integrated into the tubing or coupled via the appropriate adapter 552. In certain aspects the filter is an anti-microbial filter, e.g., an OTS bacterial/viral filter.

[00064] The procedural hood can be attached or fastened to a bed, gurney, litter or other surface by a tether with an attachment mechanism. The procedural hood can include attachment 421 in the bottom third of a wall to secure the hood to a surface such as a bed, litter, etc. The attachment can be a clip to fasten to bedding, hook to fasten to a rail or frame, or the like. The clip can be an alligator clip or a semi-circular clip to fasten to tubing or a bed, litter, or gurney rail. The attachment can be coupled to the hood by a tether, the tether being a fixed length or stretchable. The tether and be fastened to a portion of the hood by hook and loop material, adhesive, magnets, stitching, or a weld. The attachment mechanism can be attached to the tether by threading the tether through the attachment or by hook and loop, adhesive, magnets, sewn, or welded

[00065] Some advantages that can be realized with the procedural hood described herein include: (i) the mitigation of operator exposure to droplets and aerosols; (ii) simple and rapid deployment; (iii) multiple access portals enable assistance with procedures; (iv) connects to standard wall suction; (v) material and design provide improved visibility; (vi) access portals permit exceptional operator range of motion; (vii) single use device eliminates the need for cleaning and sterilization; (viii) Lightweight and foldable for easy storage, transport, and disposal; and/or (ix) clips provide secure attachment to patient bed.

II. Protective Shield

[00066] In one embodiment, the device is a clear plastic shield that clips on or connects to an ETI stylet or device, for example ETT technology described in PCT publication WO 2018/094015 and WO 2019/222196, each of which is incorporated herein by reference, as well onto any stylet or video laryngoscope that is amenable to a specific or generic connector such as clip-on or adhesive attachment configurations. Certain configurations are capable of clipping on to an endotracheal tube. [00067] The shield described herein is for the protection of the eyes and face of HCWs from accidental exposure to infectious, hazardous and undesirable substances. The shield can be a light weight, disposable shield for protecting the eyes and face of a HCW intubating a patient from accidental exposure to infectious, hazardous and undesirable substances, particularly from accidental exposure to body fluids from infected patients. The shield can include a top and bottom surface. In certain aspects, the shield is transparent. The shield can be affixed (permanently or reversibly) to an intubation device. The shield can include a connector component configured to attach the shield to the intubation device.

[00068] The shield can be formed of semi-flexible sheet plastic material. The shield can be formed of optically clear polyester sheet material or other appropriate clear plastic sheet material. The shield can be coated with an anti-glare and/or anti-fog substance (compatible with the shield material).

[00069] Referring to FIG. 9, FIG. 10 and FIG. 11 there is illustrated various views and embodiments of a shield as described herein. Shield component 901, 1001, 1101 comprises connector component 902, 1002, 1102. Shield component 901, 1001, 1101 can be in numerous regular and irregular shapes. In certain aspects, shield 901, 1001, 1101 can be circular, semi circular, square, or rectangular. In other aspects shield 901, 1001, 1101 can be any regular or irregular geometric shape.

[00070] The connector can be configured as a snap-on, clamp, threaded, adhesive, Velcro®, magnetic, other type of connector or connector component pair, or combinations thereof.

[00071] In one aspect, the connector can be a snap-on type of connector having a generally circular shape with a wall forming a connector opening along the width of the connector wall, a top opening having a plane parallel with the shield and a bottom opening having a plane parallel with the shield, and the connector opening of the connector has a dimension that is less than a diameter of the device to which the shield will be attached. The dimension of the opening of the connector is expandable in response to the insertion of a portion of the body of an intubation device. [00072] In other aspects, the connector component can be an adhesive or hook and loop (e.g., Velcro®) connector.

III. Tracheal Intubations

[00073] Yearly millions of people undergo tracheal intubation. Most tracheal intubations are performed in operating rooms by anesthesiologists or nurse anesthetists. Direct laryngoscopy (DL) is likely the most prominent technique. However, the routine use of video laryngoscopy is increasing rapidly, as VL is now present in nearly every setting where tracheal intubation occurs. The advent of VL has created new challenges that include occasional difficulty advancing the ETT into the trachea during the procedure. The ETT approach to the trachea during VL can be up to 90 degrees from axis of insertion at the mouth. The resulting approach to the vocal cords can be up to 90 degrees offset from the ETT axis of insertion at the mouth, in contradistinction DL, where the oral, laryngeal, and tracheal axis are nearly aligned during insertion and tracheal cannulation. Video laryngoscopes, particularly those with hyperangulated blades require a substantial curvature of the ETT and stylet. This offset angle and the additional skill required to insert the ETT via an indirect, 2-dimensional video screen view of the vocal cords makes ETT insertion into the glottis more difficult (the insertion phase). Furthermore, the resultant angle of the naturally downward angled trachea and the incoming ETT can cause the ETT to collide with the anterior portion of the trachea impeding ETT advancement into the trachea (the cannulation phase). A poor exposure of the glottic aperture with the video laryngoscope can exacerbate the problem. This difficulty cannulating the trachea with the ETT when using VL is a well described phenomenon. In some instances, the device described herein has a curved, hollow stylet or solid stylet that can incorporate an extending or telescoping bougie in the lumen or aroung the exterior of the stylet or otherwise coupled to a stylet as described herein. In some instances, this will allow the operator to place the ETT and stylet above or through the glottis, advance the narrow, integrated bougie through vocal cords, then advance the ETT over the bougie into the trachea. In some instances, the stylet provides the appropriate curvature in order to engage the glottic aperture or glottis during VL, and the bougie provides proper (tracheal) directionality for the ETT while axial force is applied to the ETT by the operator above. The bougie also directs the ETT downward and away from the anterior larynx where it can sometimes collide and hang up. [00074] A more immediate concern in the year 2020 is the reduction in expose to HCWs to coronavirus, in particular SARS-CoV-2. The SARS-CoV-2 virus is a betacoronavirus, similar to MERS-CoV and SARS-CoV. All three of these viruses have their origins in bats. The sequences from U.S. patients are similar to those initially identified in China.

IV. Coronaviruses

[00075] Coronaviruses (order Nidovirales, family Coronaviridae) are a diverse group of enveloped, positive-stranded RNA viruses. The coronavirus genome, approximately 27-32 Kb in length, is the largest found in any of the RNA viruses. Large Spike (S) glycoproteins protrude from the virus particle giving coronaviruses a distinctive corona-like appearance when visualized by electron microscopy. Coronaviruses infect a wide variety of species, including canine, feline, porcine, murine, bovine, avian and human (Holmes, et ah, 1996, Coronaviridae: the viruses and their replication, p. 1075-1094, Fields Virology, Lippincott-Raven, Philadelphia, Pa.). However, the natural host range of each coronavirus strain is narrow, typically consisting of a single species. Coronaviruses typically bind to target cells through Spike-receptor interactions and enter cells by receptor mediated endocytosis or fusion with the plasma membrane (Holmes, et ah, 1996, supra).

[00076] Upon entry into susceptible cells, the open reading frame (ORF) nearest the 5 ' terminus of the coronavirus genome is translated into a large polyprotein. This polyprotein is autocatalytically cleaved by viral-encoded proteases, to yield multiple proteins that together serve as a virus-specific, RNA-dependent RNA polymerase (RdRP). The RdRP replicates the viral genome and generates 3 ' coterminal nested subgenomic RNAs. Subgenomic RNAs include capped, polyadenylated RNAs that serve as mRNAs, and antisense subgenomic RNAs complementary to mRNAs. In one embodiment, each of the subgenomic RNA molecules shares the same short leader sequence fused to the body of each gene at conserved sequence elements known as intergenic sequences (IGS), transcriptional regulating sequences (TRS) or transcription activation sequences. It has been controversial as to whether the nested subgenomic RNAs are generated during positive or negative strand synthesis; however, recent work favors the model of discontinuous transcription during minus strand synthesis (Sawicki, et ak, 1995, Adv. Exp. Med. Biol. 380:499-506; Sawicki and Sawicki Adv. Expt. Biol. 1998, 440:215). [00077] A SARS-CoV-2 reference sequence can be found in GenBank accession NC_045512.2 as of March 2, 2020. This sequence is a 29903 bp ss-RNA and is referred to as the Wuhan seafood market pneumonia virus isolate Wuhan-Hu-1. The virus is Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with the taxonomy of Viruses; Riboviria; Nidovirales; Cornidovirineae; Coronaviridae; Orthocoronavirinae; Betacoronavirus; Sarbecovirus. (Wu et al. “A novel coronavirus associated with a respiratory disease in Wuhan of Hubei province, China” Unpublished; NCBI Genome Project, Direct Submission, Submitted (17-J AN-2020) National Center for Biotechnology Information, NIH, Bethesda, MD 20894, USA; Wu et al. Direct Submission, Submitted (05-JAN-2020) Shanghai Public Health Clinical Center and School of Public Health, Fudan University, Shanghai, China).

[00078] The genome of SARS-CoV-2 includes (1) a 5’UTR, (2) Orflab gene, S gene encoding a spike protein, ORF3a gene, E gene encoding E protein, M gene, ORF6 gene, ORF7a gene, ORF7b gene, ORF8 gene, N gene, ORF10 gene, and 3'UTR.

V. Intubation Devices

[00079] Certain intubation devices are described here as examples of such devices, but do not limited the type of intubation device that can be used in conjunction with the shield described herein. Certain intubation devices have a handle that allows operators to perform the insertion phase (ETT inserted through the vocal cords) by either holding the central portion of the ETT or the handle. The handle can comprise an ETT advancer portion (having a distal ETT collar portion that engages the ETT connector), a bougie advancer portion (operatively coupled to a bougie, stylet, or bougie and stylet assembly that can be positioned in the lumen of an ETT), a hypotube portion, at least two stop portions or finger rests - a first stop portion or finger rests with a thumb rest and a second stop portion. It also allows an easy hand transition from either hold so the operator can perform the cannulation phase (bougie deployment followed by ETT advancement). This handle configuration also allows the operator to reach higher above the handle in order to actuate both the bougie and the ETT advancer component.

[00080] The intubation devices can be configured to be used in conjunction with a video laryngoscopy (VL) device, a direct laryngoscopy (DL) device, or a dual purpose flexible laryngoscopy device. Each of these configurations can be used in conjunction with a standard straight bougie tip, a malleable bougie tip, or an offset bougie tip. In certain aspects the tip is flexible and bends when encountering tissue in the larynx and trachea. In other aspects the tip maintains a memory or shape in that once positioned the tip can maintain the position of shape, e.g ., an offset position. In other aspects the tip can be permanently formed in an offset position.

[00081] In some instances, an intubation device is configured to be used by one person during a tracheal intubation of a subj ect. In some instances, the device is configured to be used for tracheal intubation of a human.

[00082] Certain embodiments of the device can be used during video laryngoscopy. The insertion of the ETT using a stylet can be with the assistance of a video or direct laryngoscope. Operator(s) can steer ETT towards the glottic aperture, direct soft-tipped bougie and ETT tip through the glottis, and glide bougie followed by the ETT into the trachea with unparalleled ease. The devices described herein can help overcome the challenge encountered in advancing ETT into the trachea during VL despite an adequate view of the vocal cords. The devices can also facilitate VL or DL intubation during less than optimal VL OR VL views. Therefore, some embodiments of the device disclosed herein can be used to facilitate tracheal intubation during direct laryngoscopy (DL) under less than ideal intubating conditions. The devices decried herein can be of particular benefit to operators outside-of-the-operating room during emergency tracheal intubation, and in austere conditions encountered by EMS personnel, military medics, and critical care air transport teams.

[00083] In certain embodiments the shield described herein can be included in a pre-sterilized medical procedure kit and used for various medical procedures. In certain aspects sterilized procedure kits are provided with a plurality of components used in connection with a particular medical procedure. Certain embodiments are directed to sterilized kits to maintain a sterile environment or reduce the risk for infection during a procedure. Any materials that will be in contact with the patient can be provided in sterile compartments or packaging that can be opened just prior to use in order to maintain sterility or reduce contamination.

[00084] The shield described herein can be used for VL and DL inside or outside the operating room setting. VL use has increased in out-of-the-operating room and out-of-hospital tracheal intubation settings. In these settings, non-anesthesiology personnel are usually the operators, and they have varying degrees of airway management skill and experience. These operators may particularly benefit from a device like those described herein. Therefore, the devices can be used in the operating room, emergency room, intensive care units, on location medial emergencies by EMS/Fire units, military field and air transport applications.

[00085] Unless excluded, all elements and desctiption from each embodiment can be used in conjunction with other descirbed embodiments.

VI. Examples

[00086] The following examples as well as any figures are included to demonstrate preferred embodiments of the invention. It should be appreciated by those of skill in the art that the techniques disclosed in the examples or figures represent techniques discovered by the inventors to function well in the practice of the invention, and thus can be considered to constitute preferred modes for its practice. However, those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention.

EXAMPLE 1

ASSESSMENT OF AEROSOL CLEARANCE AND CONTAINMENT USING THE STAT ENCLOSURE

DURING A SIMULATED AEROSOL GENERATING PROCEDURE.

[00087] The test was an assessment of aerosol particle clearance using the STAT Enclosure NP during a simulated aerosol generating procedure. The objective of the bench performance test was to assess the rate of aerosol particle clearance of a protective barrier enclosure (PBE) device, the STAT Enclosure NP, to clear aerosol particles of various sizes that are commonly produced by patients undergoing aerosol generating procedures (AGP’s) such as endotracheal intubation. An additional objective of the bench performance test was to assess the ability of a protective barrier enclosure (PBE) device to contain aerosol particles of various sizes that are commonly produced by patients undergoing aerosol generating procedures (AGP’s) such as endotracheal intubation.

[00088] Methods

[00089] The test method is adapted from a recently published in-situ simulation model (Simpson, et. al.) to access PBE’s. The method uses a nebulizer to generate aerosol, producing an exaggerated number of airborne particles of various sizes. A particle counter placed inside or outside the enclosure continuously measures the number of particles of specific sizes during the experiment time course. Overall, the test is not a typical case and represents an exaggerated condition that is useful to access device performance.

[00090] The test article. STAT Enclosure NP is a production equivalent device and is an initial build by the manufacturer (Lighthouse for the Blind, San Antonio, TX). The device does not require sterilization and was tested as supplied.

[00091] Experimental environment. Due to COVID-19 pandemic constraints, access to a hospital ICU was not possible. Therefore, the typical air flow controls of the hospital environment were not available. To best replicate this environment, the experimental set-up was isolated in a designated lab experiment room with the adjacent lab as a control center, housing the portable suction pump and the foot pump with tubing that extended into the experiment room. Closing doors of each room allowed for efficient experiment room equilibrium prior to each trial and reasonable stable air flow during each experiment.

[00092] In-situ simulation model. The simulation experiments were carried out in a 10’xl l’ laboratory space. An airway mannequin positioned on a medical gurney was used to simulate the patient’s head and was used as an attachment for the nebulizer output. The STAT Enclosure was positioned over the top of the mannequin and secured using the provided straps as intended. The suction pump tubing assembly was connected to the evacuation port on the enclosure. The room door was closed to allow air flow equilibration prior to starting each experiment. The experiment duration was 30-minute total acquisition time. At time= 0 min, the suction pump, particle analyzer and the nebulizer were turned on. The nebulizer ran for 30 seconds to fill the enclosure with aerosol particles and then turned off for the remainder of the 30 min acquisition. Triplicate trials were run with the analyzer probe inside the enclosure and outside the enclosure. Background particle measurements were performed prior to the start of the experiment trials (probe inside and outside enclosure). In containment studies a foot-pump was used to intermittently deliver a burst of air to simulate a patient coughing episode. The pump was connected to a tubing system that routes underneath the PBE device and positioned next to the mannequin’s mouth. In relevant experiments, coughing was introduced every 30 seconds by a single rapid compression of the foot pump, located in the adjacent control center to minimize disruption.

[00093] Generation of aerosolized particles. Using a standard nebulizer (Hudson RCI “Micro Mist” Small volume Nebulizer, Teleflex, Wayne, PA, USA), 5 mL of normal saline was nebulized at ~6 L/min with the outlet positioned just above the simulated patient’s mouth.

[00094] Particle counting and data collection. A Lighthouse Handheld 3016 airborne particle counter (Fremont, CA) capable of measuring various particle sizes in the target range (0.3, 0.5, 1.0, 2.5, 5.0, and 10 microns) was positioned to be at operator head height and immediately in front of the operator’s head. Airborne particle counter flow rate was set to 2.83 L/min, with detection of the air every second and recorded as 3 second summations. Particle measurements were taken for 30 min after starting the nebulizer at time=0 for the clearance study and for 6 minutes after starting the nebulizer in the containment studies. At the end of each trial, the room doors were opened to allow 0.3 pm particle counts to passively return to background levels before the start of the next trial. Particle data was downloaded from the particle counter into Excel for processing and analysis.

[00095] Suction (negative pressure). Simulated wall suction was generated using a continuous suction system (Impact, more details) operated at the low setting of 30L/min, lower than what is typically provided from hospital wall suction (~80L/min), representing a more challenging environment for particle containment. The suction device was connected to the STAT Enclosure NP’s evacuation port using standard tubing with an in-line viral filter (as supplied). For all experiments using NP, the suction pump was located in the adjacent room, isolated from the experiment lab space.

[00096] Data Analysis. Particle data (six particle sizes measured simultaneously) was collected at each trial (n=3 for each group); the STAT Enclosure with negative pressure (portable suction), probe inside the enclosure and outside the enclosure. Air particle measurements were taken every second and recorded as 3 sec summations over the 30-minute acquisition 1-minute averages were calculated for the 30-minute acquisition and the median value for the triplicate trial was reported for the result for the clearance study. For containment studies 5-second averages were calculated for the 6-minute acquisition and the median value for the triplicate trial was reported for the result. The background particle level was expressed as the average of the replicate background measurements.

[00097] The study with limited replicates was intended to be informative and provide observation of general trends. Statistical methods to analyze the differences among groups were not performed.

[00098] The tests were intended to be informative since there are no established standards for aerosol clearance using a protective barrier enclosure. However, the STAT Enclosure NP was able to contain and evacuate the aerosol load produced inside the enclosure, returning to background levels within the 30 min experiment time course.

[00099] Results

[000100] Clearance. One-minute averages of the total particle counts were calculated for the 30- minute acquisition and the median value for the triplicate trial was reported, shown in the graph (FIG. 5) and detailed in Table 1. The maximum particle count was -120000, achieved after 2 minutes and the rate of decay is illustrated in the graph. The inset image in the graph shows the adjusted range of total particle counts (y-axis), maximized at 10000 particles, better illustrating the time point (17 min) when 95% reduction (-6000 particles) of the maximum particle counts is achieved. Total particle counts returned to background levels over the 30-minute time course.

Table 1. Result summary of particle data for each group tested over the 30-minute experimental time course. The reported total particle values (all sizes summed) are 1 -minute averages of the 3 second data acquisitions and represent the median for the triplicate experiments.

[000101] For each sample group (n=3 trials for each group), experiment data was collected using the Lighthouse particle counter, programmed to acquire data for each of the six particle sizes, collected every second for 30 minutes, and recorded as a 3-second sum. Raw acquisition data was downloaded from the particle counter using the Wolf Sense PC software and exported to Excel. Raw data was processed in excel and consisted of the summation of the six individual particle size counts at each 3-second data record providing the total particle counts. Next, 1 -minute averages of the total counts were calculated. For the triplicate experiments, the median was calculated and used for result reporting (Table 1).

[000102] Aerosol generating procedures (AGP’s) such as endotracheal intubation potentially put healthcare personnel at an increased risk for pathogen exposure and infection. Therefore, the necessity to protect front-line health care workers during the COVID-19 pandemic has spurred the development of technology that can provide additional protection and decrease the risk of HCP exposure to infectious respiratory viruses. A protective barrier enclosure (PBE) that can be placed over the head of an infected patient can provide several potential benefits; adds an extra layer of barrier protection in addition to standard PPE and aids in containing/blocking droplets and aerosolized particles during the aerosol generating procedures. This can help reduce the potential for widespread distribution of virus in a busy trauma bay, emergency ward, or crowded critical care setting.

[000103] The aerosol particle clearance experiments were intended to provide guidance to HCP’s with respect to the approximate time the enclosure should remain over the secured patient, decreasing particle levels inside the enclosure close to background after the patient no longer represents a risk.

[000104] Although the experimental design is it takes to clear aerosol particles from inside the enclosure

[000105] The nebulizer produces aerosol that is visible to the naked eye and it is useful to observe the air flow dynamics during the test trials. However, it is noted that the amount of aerosol produced by the nebulizer is likely exaggerated relative to typical clinical conditions and represents an extreme challenge for the PBE.

[000106] With the analyzer probe inside the enclosure, we recorded a maximum amount of total particles after 2 minutes, reaching -120000.

[000107] Testing data suggests that the STAT Enclosure NP, when used with a standard, suction device (30L/min) can evacuate a substantial portion (-95% after 15 minutes) of aerosol particles produced during a typical AGP, and when combined with standard PPE, could decrease the operator’s potential risk of exposure when ready to remove and dispose of the enclosure. Also, measurements outside of the enclosure indicated that the enclosure was able to contain the aerosol particles produced within the device, maintaining levels similar to background over the 30-minute time course.

[000108] More robust negative pressure would likely be available using standard hospital wall suction and would undoubtedly be more beneficial at containing aerosol particles within the enclosure and enhancing evacuation. [000109] Containment. 5-second averages of the total particle counts were calculated for the 6- minute acquisition and the median value for the triplicate trial was reported, shown in the graph (FIG. 6.) and detailed in Table 2. The inset image in the graph shows the adjusted range of total particle counts (y-axis), maximized at 5000 particles, better illustrating the results of the STAT Enclosure NP relative to no barrier and the plexiglass box.

[000110] Aerosol generating procedures (AGP’ s) such as endotracheal intubation potentially put healthcare personnel at an increased risk for pathogen exposure and infection. Therefore, the necessity to protect front-line health care workers during the COVID-19 pandemic has spurred the development of technology that can provide additional protection and decrease the risk of HCP exposure to infectious respiratory viruses. A protective barrier enclosure (PBE) that can be placed over the head of an infected patient can provide several potential benefits; adds an extra layer of barrier protection in addition to standard PPE and aids in containing/blocking droplets and aerosolized particles during the aerosol generating procedures. This can help reduce the potential for widespread distribution of virus in a busy trauma bay, emergency ward, or crowded critical care setting.

[000111] The acrylic plexiglass box was one of the earliest non-negative pressure PBE’s introduced, consisting of large open arm access ports in the front of the device to perform the airway procedure. However, recent published reports suggested that these devices may actually increase the operator exposure to potentially infectious aerosols when performing airway procedures on infected patients, exacerbated by patient coughing episodes. Aerosol particles can escape through the gaps in the access ports when the operator’s arms are inserted to perform the airway procedure (Simpson, et. al).

[000112] The nebulizer produces aerosol that is visible to the naked eye and it is useful to observe the air flow dynamics during the test trials. However, it is noted that the amount of aerosol produced by the nebulizer is likely exaggerated relative to typical clinical conditions and represents an extreme challenge for the PBE.

[000113] For the “no barrier” sample measurement, an increase in total particles in the room was observed over the 6 minutes that was similar to the data presented in the Simpson publication, albeit reaching a slightly higher total count that was likely due to the smaller room dimensions. Also, it is contemplated that the inability to control laboratory HVAC conditions to simulate the hospital ICU setting did not significantly impact the experimental outcome. As reported previously, for the plexiglass box, intermittent simulated coughing activity resulting in spikes in particle levels.

[000114] Testing data suggests that the STAT Enclosure NP, when used with a standard, suction device (30L/min) can contain a substantial portion of aerosol particles produced during a typical AGP, and when combined with standard PPE, could decrease the operator’s potential risk of exposure. Particle levels outside of the enclosure, measured near the operators mouth during a procedure, were maintained at levels similar to room background. More robust negative pressure would be available using standard hospital wall suction and would undoubtedly be more beneficial at containing aerosol particles within the enclosure and enhancing evacuation.

Table 2. Result summary of particle data for each group tested over the 360 sec experimental time-course. The reported total particle values (all sizes summed) are 5 second averages of the 1 second data acquisitions and represent the median for the triplicate experiments.

Claims

1. A protective procedural hood comprising: a collapsible frame that when expanded for use forms a procedural hood having a frame supporting 2 or more sidewalls, a front wall, rear wall, a top wall, and an at least a partially open bottom wall or open bottom wall; the procedural hood when expanded defining a procedural space within the walls; and one or more access points formed in one or more of the walls; wherein the procedural hood when expanded and in use is configured to be placed over and to contain a portion of a subject’s body.

2. The protective procedural hood of claim 1, wherein the top wall is transparent and planar.

3. The protective procedural hood of claim 1 or claim 2, wherein at least one wall has at least one access port.

4. The protective procedural hood of any one of claim 1 to 3, wherein at least one wall has at least two access ports.

5. The protective procedural hood any one of claim 1 to 4, wherein the procedural hood is configured to collapse for storage and transport.

6. The protective procedural hood of any one of claim 1 to 5, wherein the procedural hood has a left side wall and a right side wall.

7. The protective procedural hood of any one of claim 1 to 6, wherein the walls are a flexible plastic.

8. The protective procedural hood of any one of claim 1 to 7, wherein the top, side, front and rear walls are polyurethane having a thickness between 0.002 and 0.050 inches.

9. The protective procedural hood of any one of claim 1 to 8, wherein the walls are polyurethane having a thickness of 0.004 inches.

10. The protective procedural hood of any one of claim 1 to 9, wherein at least the top wall is transparent.

11. The protective procedural hood of any one of claim 1 to 10, wherein all walls are transparent.

12. The protective procedural hood of any one of claim 1 to 11, wherein the walls when in an expanded configuration form a three-dimensional quadrilateral.

13. The protective procedural hood of any one of claim 1 to 12, wherein the protective procedural hood is 300 to 600 mm long (L), 300 to 600 mm wide (W), and 300 to 700 mm in height (H).

14. The protective procedural hood of any one of claim 1 to 13, further comprising one or more access points.

15. The protective procedural hood of any one of claim 1 to 14, wherein the access point is a port for a gas supply, a vacuum port, or hand/instrument access port.

16. The protective procedural hood of claim 15, wherein the hand/instrument access port has a diameter of about 9 inches.

17. The protective procedural hood of claim 16, wherein the vertical midline of the hand/instrument access port is position below the vertical midline of the wall.

18. The protective procedural hood of any one of claim 15 to 17, wherein the hand/instrument access port is covered by fabric.

19. The protective procedural hood of claim 18, wherein the fabric is coupled to the port by a fabric trim.

20. The protective procedural hood of claim 18 or claim 19, wherein the fabric covering comprises two or more fabric panels.

21. The protective procedural hood of any one of claim 14 to 20, wherein the fabric panels overlap.

22. The protective procedural hood of any one of claim 14 to 21, wherein the fabric is a 4 way stretch fabric

23. The protective procedural hood of any one of claim 14 to 23, wherein the fabric is 80% polyester / 20% spandex.

24. The protective procedural hood of claim 15, wherein the gas supply port or the vacuum port is operably coupled to a filter.

25. The protective procedural hood of any one of claim 1 to 24, further comprising a skirt or drape attached to at least one bottom edge.

26. The protective procedural hood of any one of claim 1 to 25, wherein the skirt or drape comprises a weighted edge to secure the skirt or drape about the subject’s body when in use.

27. The protective procedural hood of any one of claim 1 to 26, wherein the skirt or drape is attached to all four edges of the bottom edge.

28. A protective shield for a tracheal cannulation device comprising: a shield having a top and bottom surface with the top surface configured to face the device user and the bottom surface configured to face the patient being intubated with the planar surface of the shield to be positioned substantially perpendicular to the long axis of the tracheal cannulation device during use; and a connector configured to attach the shield to the body of a tracheal cannulation device.

29. The shield of claim 28, wherein the shield is transparent.

30. The shield of claim 28, wherein the shield is substantially flat.

31. The shield of claim 28, wherein the shield comprises a notch formed in the shield to accept a portion of a tracheal cannulation device positioning a portion of the shield around a portion of the circumference of the tracheal cannulation device.

32. The shield of claim 28, wherein the connector is a reversible connector configure to allow attachment and detachment of the shield.

33. The shield of claim 28, wherein the connector is a snap-on connector, adhesive connector, a clamp, or a magnetic connector.

34. The shield of claim 28, wherein the connector of the shield complements a connector component on the tracheal cannulation device.

35. The shield of claim 28, wherein the tracheal cannulation device comprises a complement to form a connection with the connector.

36. The shield of claim 28, wherein the shield is circular.

37. The shield of claim 36, wherein circumference or the circular shield has an arc of 90 degrees or 340 degrees.

38. The shield of claim 28, wherein the shield is rectangular.

39. The shield of claim 28, wherein the connector is disposed on the outer edge of the shield.

40. The shield of claim 28, wherein the connector is disposed at the midpoint of the shield plane.