WO2021203145A1

WO2021203145A1 - Respiratory aerosol containment apparatus, kit, and associated methods

Info

Publication number: WO2021203145A1
Application number: PCT/US2021/070353
Authority: WO
Inventors: Kaushik Mukherjee; Darcy MAINVILLE; Borin HOU
Original assignee: Loma Linda University
Priority date: 2020-04-02
Filing date: 2021-04-02
Publication date: 2021-10-07

Abstract

A respiratory aerosol containment apparatus, kit, and associated methods reduce the airborne transmission of respiratory aerosols during endotracheal intubation and related procedures. In one or more embodiments, the apparatus may include a frame and a sheet of plastic draped over the frame. In one or more embodiments, the method may include positioning the frame over the head region of a patient lying in a supine position and placing the sheet of plastic over the frame such that the plastic creates an enclosed space about the patient. The frame and sheet of plastic are maintained in position about the patient from a time prior to, during, and after a respiratory procedure is conducted in order to contain any respiratory aerosols that may be emitted by the patient during the procedure.

Description

RESPIRATORY AEROSOL CONTAINMENT APPARATUS, KIT, AND ASSOCIATED METHODS

CROSS-REFERNCE TO RELATED APPLICATIONS

[0001] This application is a PCT of U.S. Application No. 63/004,284, filed April 2, 2020, titled “RESPIRATORY AEROSOL CONTAINMENT APPARATUS, KIT, AND ASSOCIATED METHODS,” which is incorporated herein by reference in its entirety.

FIELD OF DISCLOSURE

[0002] One or more embodiments relate to prophylactic apparatuses, kits, and associated methods of using same to mitigate the airborne transmission of respiratory aerosols. In at least one embodiment, such prophylactic apparatuses, kits, and associated methods include respiratory aerosol containment apparatuses used prior to, during, and after endotracheal intubation procedures and other respiratory therapy procedures.

BACKGROUND

[0003] Respiratory aerosols are particles of respiratory secretions that are emitted from the nose or mouth of a patient and which may contain respiratory aerosol transmittable diseases. Such respiratory aerosols are most prominent, and their airborne transmission is highest, when a patient is undergoing an endotracheal intubation procedure — whether that be the insertion of an endotracheal tube, the removal of an endotracheal tube or the adjustment of same — or other airway procedure. The unabated airborne transmission of respiratory aerosols during these respiratory procedures potentially exposes those healthcare providers performing such procedures to respiratory aerosol transmittable diseases that the patient may have. In many cases, the healthcare providers performing respiratory procedures on patients with unknown, or even known, respiratory aerosol transmittable diseases are only protected from the airborne respiratory aerosols emitted from the patient by the personal protective equipment, e.g ., masks, face shields, etc., worn by the healthcare providers themselves. Further, because in at least some instances, respiratory aerosols may linger in the air for several minutes to several hours, the risk of disease transmission to anyone in the vicinity of the patient is increased for an extended period of time.

[0004] Previous aerosol containment apparatuses and methods have proven to be bulky devices that take up precious space around the patient, non-portable devices being either tethered to a particular healthcare facility location or too large to be easily transported between treatment rooms, devices of poor fitting design when used in conjunction with an ill patient, and/or single use devices in which none of their components could be disinfected and reused. Therefore, Applicant recognized a need for a prophylactic apparatus, kits, and methods of using same, that can solve one or more of the shortcomings in the art.

SUMMARY

[0005] Applicant recognized that, especially during epidemics and pandemics caused by respiratory aerosol transmittal diseases and when traditional medical resources are scarce, personal protective equipment that is worn by healthcare providers should not be the first and/or only prophylactic against the transmission of respiratory aerosols from patients with respiratory aerosol transmittable diseases. Applicant further recognized that an aerosol containment apparatus, arranged and designed to mitigate respirator aerosols emitted from a patient during such times, must be readily constructible from available materials, have one or more components that can be disinfected and reused, and/or be portable to be placed in operational use about an unresponsive patient with no modification, e.g ., structural modification. Thus, Applicant discloses herein one or more embodiments of a respiratory aerosol containment apparatus, and associated methods of use, that act to reduce the airborne transmission of respiratory aerosols during respiratory therapies, such as during endotracheal intubation and related procedures, but that can be readily constructed from commonly available materials, can utilize reusable components capable of being readily disinfected, and/or can be operationally positioned proximate the patient without modification.

[0006] In one or more embodiments, a respiratory aerosol containment apparatus may include a frame having two spaced-apart, rearward support legs. Each of the support legs is substantially vertical and has a top end portion with a substantially horizontal segment connected thereto that extends outwardly in a frontward direction from the top end portion. Each support leg also has a bottom end portion with a substantially horizontal foot segment connected thereto that also extends outwardly in a frontward direction from the bottom end portion. The horizontal segments have frontward end portions and a substantially horizontal, stabilizing first brace member connected thereto that extends laterally therebetween proximate the frontward end portions. The horizontal segments also have a substantially horizontal, stabilizing second brace member connected thereto that extends laterally therebetween proximate the top end portions of the support legs. The horizontal segments and first and second brace members define a top section of the frame. In at least one embodiment, each of the foot segments has a longer horizontal length than each of the horizontal segments. A plastic covering having an edge portion is positioned over the top section of the frame and extends downwardly along each side of the frame.

[0007] In one or more embodiments, a method of containing respiratory aerosol during endotracheal intubation procedures may include positioning a frame on a support structure proximate an upper body or head region of a patient when the patient lies in a substantially horizontal position upon the support structure. The frame has two spaced-apart, rearward support legs with each of the support legs being substantially vertical and having a top end portion. A substantially horizontal segment is connected to each of the support legs and extends outwardly in a frontward direction from the top end portion. Each support leg also has a bottom end portion with a substantially horizontal foot segment connected thereto that also extends outwardly in a frontward direction from the bottom end portion. The horizontal segments have frontward end portions and a substantially horizontal, stabilizing first brace member connected thereto that extends laterally therebetween proximate the frontward end portions. The horizontal segments also have a substantially horizontal, stabilizing second brace member connected thereto that extends laterally therebetween proximate the top end portions of the support legs. The horizontal segments and first and second brace members define a top section of the frame. In at least one embodiment, each of the foot segments has a longer horizontal length than each of the horizontal segments.

[0008] The frame may be positioned with the top or upper section above the upper body or head region of the patient, e.g ., overlying, and with the foot segments extending along the support structure on either side of the patient toward a lower body or foot region of the patient when the patient lies in the substantially horizontal position upon the support structure, e.g. , a bed, gurney, mattress, cot, mat, or other support structures as will be understood by those skilled in the art. The method may also include positioning a plastic covering, e.g. , a sheet of plastic, plastic bag, having one or more edge portions over the top section of the frame and permitting the one or more edge portions to extend downwardly along each side of the frame, with at least a portion of the one or more edge portions extending vertically in a downward direction below the horizontal position of the patient when the patient lies in the substantially horizontal position upon the support structure. Further, the method may include maintaining the frame as positioned for a period of time that extends from a time before to another time after an endotracheal intubation procedure is performed upon the patient while the patient lies in a substantially horizontal position upon the support structure.

[0009] In one or more embodiments, a kit for containing respiratory aerosols during endotracheal intubation procedures comprises a disassembled, assembled or folded frame, at least one plastic sheeting having one or more edge portions, and an antiseptic solution used to disinfect outer surfaces of the assembled frame between uses. The frame when assembled has two spaced apart, rearward support legs. Each of the support legs is substantially vertical and has a top end portion with a substantially horizontal segment connected thereto that extends in a frontward direction from the top end portion. Each support leg also has a bottom end portion with a substantially horizontal foot segment connected thereto that extends outwardly in a frontward direction from the bottom end portion. The horizontal segments have frontward end portions and a substantially horizontal, stabilizing first brace member connected thereto that extends laterally therebetween proximate the frontward end portions. The horizontal segments also have a substantially horizontal, stabilizing second brace member connected thereto that extends laterally therebetween proximate the top end portions of the support legs. The horizontal segments and first and second brace members define a top section of the frame. In at least one embodiment, each of the foot segments has a longer horizontal length than each of the horizontal segments. In one or more embodiments, the at least one plastic sheeting is arranged and designed to be positioned over the top section of the assembled frame and extend downwardly along each side of the assembled frame. In one or more embodiments, a portion of the plastic sheeting may be positioned or tucked underneath one or both of the foot segments.

BRIEF DESCRIPTION OF DRAWINGS

[0010] These and other features, aspects, and advantages of the disclosure will become better understood with regard to the following descriptions, claims, and accompanying drawings. It is to be noted, however, that the drawings illustrate only several embodiments of the disclosure and, therefore, are not to be considered limiting of the scope of the disclosure.

[0011] FIG. 1 A is a diagram showing an assembled respiratory aerosol containment frame from a perspective view according to one or more embodiments of the disclosure; [0012] FIG. IB is a diagram showing the assembled respiratory aerosol containment frame of FIG. 1 A from a top view according to one or more embodiments of the disclosure;

[0013] FIG. 1C is a diagram showing the assembled respiratory aerosol containment frame of FIG. 1 A from a side view according to one or more embodiments of the disclosure;

[0014] FIG. ID is a diagram showing the assembled respiratory aerosol containment frame of FIG. 1 A from a frontal view according to one or more embodiments of the disclosure;

[0015] FIG. IE is a diagram showing the assembled respiratory aerosol containment frame of FIG. 1 A from another perspective view according to one or more embodiments of the disclosure;

[0016] FIG. 2 is a diagram showing another embodiment of an assembled respiratory aerosol containment frame from a perspective view according to one or more embodiments of the disclosure;

[0017] FIG. 3 is a representation of a respiratory aerosol containment apparatus, according to one or more embodiments of the disclosure, in which an assembled respiratory aerosol containment frame along with plastic sheeting supported thereon is shown as such may be positioned about a patient lying on a support surface;

[0018] FIG. 4 is a representation of an assembled respiratory aerosol containment frame, according to one or more embodiments of the disclosure;

[0019] FIG. 5A illustrates a respiratory aerosol containment frame in an unfolded, ready to use condition according to one or more embodiments of the disclosure;

[0020] FIG. 5B illustrates the respiratory aerosol containment frame of FIG. 5A in a folded condition for storage or transport according to one or more embodiments of the disclosure;

[0021] FIGS. 5C-5F are diagrams that illustrate how the respiratory aerosol containment frame of FIG. 5A may be folded for storage or transport according to one or more embodiments of the disclosure; and

[0022] FIG. 6 is a perspective view of a kit, according to one or more embodiments of the disclosure, that includes an assembled respiratory aerosol containment frame, a container of plastic sheets or bags, and a container of disinfectant solution/wipes. PET ATT, ED DESCRIPTION

[0023] So that the manner in which the features and advantages of the embodiments of the systems and methods disclosed herein, as well as others, which will become apparent, may be understood in more detail, a more particular description of embodiments of apparatuses and methods briefly summarized above may be had by reference to the following detailed description of embodiments thereof, in which one or more are further illustrated in the appended drawings, which form a part of this specification. It is to be noted, however, that the drawings illustrate only various embodiments of the apparatuses and methods disclosed herein and are therefore not to be considered limiting of the scope of the apparatuses and methods disclosed herein as it may include other effective embodiments as well.

[0024] In one or more embodiments, a respiratory aerosol containment apparatus and associated methods of using same to mitigate the airborne transmission of respiratory aerosols are disclosed. In at least some embodiments, the aerosol containment apparatus, arranged and designed to mitigate respirator aerosols emitted from a patient, has one or more of the following features that are further disclosed hereinbelow: be readily constructible from commonly available materials, have one or more components that can be disinfected and reused, and/or be portable to be placed in operational use about an unresponsive patient with no significant structural modification.

[0025] Starting at FIG. 1A, a frame 10 of a respiratory aerosol containment apparatus 100 (see, e.g., FIG. 3) is illustrated according to one embodiment of the disclosure. Frame 10 has two spaced apart support legs 22, 23 that are positioned rearward as illustrated. Each of the support legs 22,

23 is shown as being substantially vertical, however, in one or more embodiments, the support legs 22, 23 may have an angle with the horizon that is less than or more than 90 degrees (i.e., an angle with either substantially horizontal members 32, 33 or substantially horizontal members 42, 43 that is less than 90 degrees). Support leg 22, shown on the left in FIG. 1 A, has a top end portion

24 and support leg 23, shown on the right in FIG. 1A, has a top end portion 25. Substantially horizontal segments 32, 33 connect to support legs 22, 23, respectively, proximate the top end portions 24, 25, respectively. As shown, substantially horizontal segments 32, 33 extend frontwards or in a frontward direction from their connections to respective support leg 22, 23. In at least one embodiment, substantially horizontal segments 32, 33 are substantially parallel to each other. However, in one or more other embodiments (not shown), substantially horizontal segments 32, 33 may extend closer to each other as they extend in a frontward direction to frontward end portions 34, 35. In one embodiment (not shown), the substantially horizontal segments 32, 33 may meet and connect at their frontward end portions 34, 35, thereby defining a triangular top section 60 (FIG. 3).

[0026] Each of the support legs 22, 23 also has a bottom end portion 26, 27. Substantially horizontal foot segments 42, 43 connect to support legs 22, 23, respectively, proximate the bottom end portions 26, 27, respectively. As shown, substantially horizontal foot segments 42, 43 extend frontwards or in a frontward direction from their connections to the respective support legs 22, 23. Each of the foot segments 42, 43 have a frontward foot segment end portion 44, 45 that may include, e.g ., an end cap. In at least one embodiment, substantially horizontal foot segments 42, 43 are substantially parallel to each other. However, in one or more other embodiments (not shown), substantially horizontal foot segments 42, 43 may extend closer to each other as they extent frontwards to frontward foot segment end portions 44, 45. Each of the support legs 22,23 should be spaced apart a sufficient distance such that the upper body and/or head region of a patient may be positioned therebetween. Likewise, substantially horizontal foot segments 42, 43 should also be spaced apart a sufficient distance such that the foot segment 42, 43 may extend and/or run along the sides of the torso of a patient when the frame and a patient are disposed upon a support structure 80 (FIG. 3), such as a hospital bed. In one or more embodiments, the spacing between each of the support legs 22, 23 and/or between each of the foot segments 42, 43 is at least 12 inches, at least 15 inches, at least 18 inches, at least 20 inches, at least 24 inches, at least 30 inches, or more. While the length of each of the horizontal segments 32, 33 is shown in FIG. 1 A to be approximately the same, it will be understood to those skilled in the art that the length of the individual horizontal segments 32, 33 may be different relative to each other in the frontward direction. Likewise, the length of each of the foot segments 32, 33 is shown in FIG. 1 A to be the same or approximately the same, but may have different relative lengths, especially in the frontward direction.

[0027] As shown in FIG. 1A, a substantially horizontal and stabilizing first brace member 52 extends laterally therebetween the substantially horizontal segments 32, 33 proximate the frontward end portions 34, 35 of the horizontal segments 32, 33. First brace member 52 connects on each end portion thereof to the horizontal segments 32, 33 proximate the frontward end portions 34, 35. As shown, such connection may include an curved elbow, however, any type of connection, including the use of an additional fitting, connector or coupler may be used. In one or more embodiments, the connections may be made by welding, gluing or otherwise adhering/affixing the components together. A substantially horizontal and stabilizing second brace member 54 extends laterally therebetween the substantially horizontal segments 32, 33 proximate the top end portions 24, 25 of the support legs 22, 25. In FIG. 1A, the second brace member 54 is connected to horizontal segment 32 at connection point 56 and to horizontal segment 33 at connection point 57. In this embodiment, the connection points 56, 57 are tee fittings/connectors and are positioned frontwards at least some distance from the connections of the support legs 22, 23 to the horizontal segments 32, 33 via elbow fittings/connectors proximate the top end portions 24, 25. It will be understood to those skilled in the art that such distance is governed by the spacing required by the elbow and tee fittings/connectors in close proximity. In other embodiments (not shown), such connections between the various segments and/or members may be made with clamps, welds, adhesion, or with other known types of connections. The first and second brace members 52, 54 provide stability to the support legs 22, 23 and horizontal segments 32, 33 and permit them to maintain their positioning relative to each other. The horizontal segments 32, 33 and the first 52 and second 54 brace members define a top section 60 (FIG. 3) of the frame 10.

[0028] As illustrated in FIG. 1A, the foot segments 42, 43, which support and stabilize the remaining frame segments and members, are shown as being longer in length than the length of the horizontal segments 32, 33. In this embodiment and select others, the foot segments 42, 43 are of sufficient length to provide stability to the remaining frame segments and member such that the frame stands upright at the desired angle, is stable, and does not tip over. The horizontal members 32, 33 are of a shorter length to provide access to the upper body or head region of a patient when a patient is lying longitudinally between the foot segments 42, 43 with upper body or head region lying underneath the top section 60. Such access is desirable to more easily conduct endotracheal intubation procedures, other respiratory procedures or other procedures about the chest/upper body area, such as chest compressions. In one or more embodiments, the ratio of the length of the horizontal segments 32, 33 to the length of the foot segments 42, 43 is at least about 2:3, at least about 3:5, at least about 5:7 ormore. In other embodiments, such ratio is as low as about 3:7, about 2:5, about 1:3 or less. In at least one embodiment, the ratio is between about 1:3 and about 5:7. [0029] It should be noted that in one or more embodiments of the frame, as illustrated in FIG. 1 A, the top end portions 24, 25, the frontward end portions 26, 27, the bottom end portions 26, 27 may be fittings, connectors or couplers, as known to those skilled in the art, and may include joints, elbows, etc. In at least one embodiment in which the frame may not be capable of being disassembled, or only partially capable of being disassembled, the connections between the various segments and/or members may be made through more permanent means, such as welding, fusing, brazing, or soldering. In other embodiments (not shown), at least portions of the frame may be made integral from a single material or made integral via additive manufacturing.

[0030] FIG. IB illustrates the frame 10 of FIG. 1 A from a top view, FIG. 1C illustrates the frame 10 of FIG. 1A from a side view, FIG. ID illustrates the frame of FIG. 1A from a frontal view (looking rearward), and FIG. IE illustrates another perspective view of the frame 10 of FIG. 1A, e.g ., as may be constructed from standard copper tubing and fittings.

[0031] FIG. 2 illustrates an embodiment of the frame 10 of a respiratory aerosol containment apparatus 100 (see, e.g, FIG. 3). The embodiment of FIG. 2 is similar to that of FIG. 1 A. As shown in FIG. 2, the approximate dimensions of at least one embodiment of the frame 10 are given. The various segments, members, and fittings/connectors that make up the frame 10 are also identified by number. For example, in the embodiment illustrated, the components labeled #3 are 1/2-inch copper right angle elbows, the components labeled #4 are 1/2-inch copper right angle street elbows, the components labeled #5 are 1/2-inch copper T-pieces, and the components labeled #6 are 1/2-inch copper rounded end caps. The labeled 12-inch and 18-inch segments are 1/2-inch M Type copper pipes of respective length. In at least one embodiment, metal solder is used to firmly or permanently connect the one or more of the segments, members and/or connector to each other as shown. A soldering flux also may be used to prepare the copper tubing surfaces for soldering as will be understood by those skilled in the art. While half inch diameter copper tubing is depicted in FIG. 2, those skilled in the art will recognize that tubing of other sizes may be used. Moreover, a plastic tubing, such as a medical grade polypropylene, may be used in place of the copper tubing.

[0032] FIG. 3 illustrates a method of containing respiratory aerosol during endotracheal intubation procedures that may include positioning a frame 10 on a support structure 80, such as a bed, a cot, or the floor, proximate an upper body of a patient when the patient lies in a substantially horizontal position upon the support structure 80. The frame 10 may be the embodiment of frame 10 of FIG. 1A, frame 10' of FIG. 5A or any embodiment of a frame disclosed herein. In one or more embodiments, the frame 10 may rest on a support structure, e.g ., the floor, that is different from the support structure 80 that supports the patient. In such situations, the support legs 22, 23 of the frame 10 may need to be lengthened or made to be telescopic (as is known to those skilled in the art) in order to place the top section 60 of the frame a distance above the upper body or head region of the patient. As shown in FIG. 3, the frame 10 is positioned with the top section 60 above the upper body of the patient with the foot segments 42, 43 extending along the support structure 80 on either side of the patient toward a lower body of the patient while the patient lies in the substantially horizontal position upon the support structure 80. In one or more embodiments, the frame 10 may be placed in such position by sliding the foot segments 42, 43 under a portion of the support structure 80, e.g. , under a mattress of the bed. In one or more embodiments, the headboard of the support structure 80 may need to be removed prior to positioning the frame 10, and/or the height of the support structure 80 adjusted. With no horizontal brace member extending and connecting between the horizontal foot segments 42, 43, the horizontal foot segments 42, 43 may be easily positioned on either side of a supine patient without disturbing or touching the patient and without any further structural modification. In one or more embodiments (not shown), the support legs 22, 23 may rigidly connect to the support structure 80, such that foot segments 42, 43 are optional. Such connection may be through slots in the support structure that receive each support leg. In one or more other embodiments, such connection may be realized through clamps, corresponding fittings, tethers, etc.

[0033] The method also includes positioning a plastic covering 70, such as a plastic sheeting, a plastic bag, or other impervious covering, that has one or more edge portions (i.e., sides) positioned over or positioned to overlay the top section 60 of the frame 10. In one or more embodiments, the plastic covering, plastic sheeting, plastic bag, or other imperious cover is transparent or at least translucent so that the healthcare provider can see therethrough to the patient. The plastic may have an interior or patient-facing side, or coating thereon, that is slightly electrostatically charged in order to attract to the plastic any viruses, bacteria and other pathogens that may be emitted by the patient. In some embodiments, the plastic may have an interior or patient-facing side that is coated with a biocide, disinfectant, or virucide to kill microorganisms, including viruses, that may be emitted by the patient. In still other embodiments, the plastic may be made of or impregnated with a chemical or additive that has disinfecting properties, e.g. , Microban, as will be understood by those skilled in the art. In one or more embodiments, the plastic covering 70 may have a portion that fits snugly over the top section 60 of the frame 10, e.g ., the plastic covering may have a square middle portion that fits exactly over a square top section 60. Such form-fitting plastic covering may facilitate placement of the plastic covering about the frame 10 and may additionally facilitate proper orientation of the plastic covering. Moreover, the top portion of the plastic covering may include a logo or other marking thereon to readily indicate the exact positioning of the top portion of the plastic covering over the top section of the frame 10. The one or more edge portions of the plastic covering 70 are permitted to extend downwardly along each side of the frame 10, which creates an enclosed or at least semi-enclosed space or chamber about the patient. This enclosed or semi-enclosed chamber is thus created by the tent of the frame 10 and plastic covering 70 in combination, which overlays the upper body or head region of the patient. In one or more embodiments, at least a portion of the one or more edge portions extends vertically downwardly below the horizontal position of the patient, proximate the support structure 80, when the patient lies in the substantially horizontal position upon the support structure 80.

[0034] The frame 10 is maintained as positioned about the upper body or head region of the patient for a period of time that extends from a time before to another time after an endotracheal intubation procedure is performed upon the patient while the patient lies in a substantially horizontal position upon the support structure 80. In other words, the frame 10 is moved and positioned over the upper body or head region of a patient lying in a supine position on a support structure 80 and the plastic covering 70 is positioned over the frame 10 (/. ., over the top section 60 thereof) prior to any procedure being performed on the patient that may cause the patient to emit respiratory aerosols. The frame 10 and plastic sheeting that is draped over the frame 10 remain in position over the patient for the duration of any such procedure and for a pre-determined time after such procedure is concluded (i.e., the time for any emitted respiratory aerosols to settle and no longer be airborne). During the time that the frame 10 and plastic covering are in place, healthcare providers may reach under the plastic covering, or pull the plastic covering out of the way, to access areas adjacent the upper body or head region of the patient positioned underneath the top section 60 of the frame 10. In a possible embodiment (not shown), one or more access holes in the plastic sheeting 70 may be cut therethrough to permit hand access by the healthcare provider to areas under top section 60 of the frame 10. The location of such access holes may be pre-selected by having perforations disposed in the plastic to facilitate the opening of such access holes without a cutting instrument. In some embodiments, one or more sleeves ( e.g ., external or internal relative to the frame 10) may be connected to the plastic sheeting to surround a hole or aperture in the plastic sheeting 70 such that the healthcare provider may access the interior of the frame through the one or more sleeves. It should be understood by those skilled in the art that the use of the respiratory aerosol containment apparatus 100 including the placement of the plastic sheeting 70 over the frame 10 does not lessen the need by healthcare providers to don or wear personal protective equipment prior to, during, or after such use.

[0035] The method further also may include tucking at least a portion of the one or more edge portions of the plastic covering 70 underneath the patient when the patient lies in the substantially horizontal position upon the support structure 80. This assists in keeping the plastic covering 70 in place and further assists in creating the enclosed space or chamber (underneath the tent of the frame 10 and plastic covering 70) to contain any respiratory aerosols emitted by the patient while at least the upper body and/or head region of the patient are enclosed within the frame 10 and plastic sheeting 70. In another embodiment, at least a portion of the one or more edge portions of the plastic covering 70 is tucked underneath at least one of the foot segments 42, 43. Tucking at least a portion of the one or more edge portions underneath at least one of the foot segments 42, 43 may be in addition to or in place of tucking at least a portion of the one or more edge portions beneath the patient. In one or more embodiments, tape or another flexible connector may be used to fasten the plastic covering 70 in place. The tape may be, used to fasten or hold the plastic covering 70 to the torso of the patient, to the support structure 80 or to portions of the frame 10 itself. The use of tape to fasten or hold the plastic covering 70 in place may be in addition to or in place of the tucking methods disclosed hereinabove. After the plastic sheeting 70 is secured, the respiratory aerosol containment apparatus 100 is ready for use and a respiratory procedure, e.g., an endotracheal intubation, may be commenced.

[0036] Once the respiratory procedure is completed and a pre-determined time has passed to ensure that any respiratory aerosols emitted by the patient are no longer airborne, then the plastic covering 70 may be removed from over the frame 10 and properly disposed of, e.g, as biohazardous waste, in a sealed plastic bag or other suitable container. The frame 10 then may be removed from proximate the upper body or head region of the patient. The method still also may include disinfecting the outer surfaces of the frame 10 with an antiseptic solution, such as a biocide or virucide, that is delivered in the form of solution- saturated wipes 94 (FIG. 6), sprays or other forms known to those skilled in the art. In at least one embodiment of the method, especially when an inadequate time for aerosol dissipation has elapsed, the respiratory aerosol containment apparatus may be removed through the following steps: First, untuck or remove the tape holding a side or edge portion of the plastic sheet/bag 70 to the patient, to the support structure 80, or the frame 10 while taking care not to flip up the plastic sheet/bag 70 or lift it away so as not to expel any respiratory aerosols contained within the enclosed space under the tent (i.e., the tent created by the frame 10 with the plastic sheet/bag 70 draped over the top section thereof). Next, gather the plastic sheet/bag 70 carefully around the sides of the frame 10 and slide the frame 10 back away from the patient’s upper torso and head region, e.g ., toward the intubating clinician. Next, gently move and set the entire frame 10 and plastic sheet/bag 70 together (i.e., the frame 10 with the plastic sheet/bag 70 in place over the top section thereof) in a corner of the room or in another out of the way location. With the respiratory aerosol transmission containment apparatus removed from about the patient, the plastic sheet/bag 70 may be safely removed and disposed of and the frame 10 properly disinfected, and optionally, disassembled or folded. In one or more embodiments, the method further may include positioning the frame 10, after disinfection, on another support structure (not shown) proximate an upper body of another patient when the another patient lies in a substantially horizontal position upon the another support structure. The method may further include folding, disassembling and/or reassembling the frame 10 as necessary.

[0037] Now turning to FIG. 4, an embodiment of the frame 10 of a respiratory aerosol containment apparatus 100 (see, e.g, FIG. 3) is illustrated. The frame 10 of this embodiment is shown as having been constructed of copper tubing and copper fittings/connectors (elbow, tees, and end caps) with the individual copper tubing and fittings/connectors being soldered, welded, or brazed together. In the embodiment of FIG. 4, the individual copper tubing components 32, 33, 52, 54 that form the top section of the frame are connected by hinges or like mechanisms to the support legs 22, 23 to allow for erecting the respiratory aerosol containment frame 10 from a folded configuration to an expanded, rigid configuration. As shown in FIG. 4, the top section is hinged to the support legs 22, 23 such that the top section may pivot over the top of the support legs and come to rest vertically against the rear side of support legs. Additionally, support legs 22, 23 may be pivotally connected to the hinges such that each support leg 22, 23 and attached foot segment 42, 43 may pivot inwardly toward the other support leg. Thus, the frame 10 of FIG. 4 may be folded when not in use for storage or transport. In at least one such embodiment, the hinges releasably lock after the frame 10 is expanded into its rigid assembled configuration. In many of the embodiments disclosed herein, copper is used as a material of construction because of its known natural antiseptic properties — both anti -bacterial and anti -viral. As those skilled in the art will appreciate, bacteria and viruses do not survive for extended periods of time on copper or copper containing surfaces. Therefore, any respirator aerosol transmissible disease-causing agents ( e.g ., bacteria or viruses) that may be found in respiratory aerosols and/or droplets that land on or otherwise come in contact with the copper or copper containing frame will have shortened virulence. It should be noted that copper- containing alloys, such as brass and bronze, also have varying degrees of such antiseptic properties and may also be used partially or fully as a material of construction for embodiments of the frame disclosed herein.

[0038] Due to the conductive properties of copper, copper alloys and other metals that may be used to construct the frame 10, care should be taken when the respiratory aerosol transmission containment apparatus is deployed in settings in which the frame 10 may come in contact with an electrical source, such as when performing certain procedures including but not limited to defibrillation or cardioversion. In these settings, the following steps are suggested: First, untuck or remove the tape holding a side or edge portion of the plastic sheet/bag 70 to the patient, to the support structure 80, or the frame 10 while taking care not to flip up the plastic sheet/bag 70 or lift it away so as not to expel any respiratory aerosols contained within the enclosed space under the tent (i.e., the tent created by the frame 10 with the plastic sheet/bag 70 draped over the top section thereof). Next, gather the plastic sheet/bag 70 carefully around the sides of the frame 10 and slide the frame 10 back away from the patient’s upper torso and head region, e.g., toward the intubating clinician. Wrap the edge portions of the plastic sheet/bag 70 around the bottom of the frame 10 to contain any respiratory aerosol that may be present in the enclosed space under the tent. Next, gently move and set the entire frame 10 and plastic sheet/bag 70 together ( i.e ., the frame 10 with the plastic sheet/bag 70 in place over the top section thereof) in a corner of the room or in another out of the way location. With the respiratory aerosol transmission containment apparatus removed from about the patient, the defibrillation or cardioversion procedure may be commenced. In one or more embodiments, a label is placed on the frame 10 to warn of the possible risk of electrical shock if the respiratory aerosol transmission containment apparatus is used in conjunction with certain procedures. [0039] FIGS. 5A-5F illustrate an embodiment of a frame 10' of a respiratory aerosol containment apparatus 100 (see, e.g., FIG. 3) that is constructed of a medical grade plastic, such as polypropylene. Medical grade polypropylene may be preferable to copper as a frame construction material, because the polypropylene does not corrode over time and may be easily disinfected by autoclaving. In one or more embodiments, frame 10' may be constructed of plastic tubing, elbows, end caps and other connectors/fittings, e.g, polyethylene tubing/connectors/fittings. In other embodiments, frame 10' may be formed through injection molding. In such embodiments, the frame 10' may be formed as an integral piece or by assembly of a limited number of components that have been formed through injection molding.

[0040] The design and configuration of frame 10' is similar to that of frame 10 as previously disclosed. Frame 10' has two spaced apart support legs 122, 123 that are positioned rearward as illustrated. Each of the support legs 122, 123 is shown as being substantially vertical, however, in one or more embodiments, the support legs 122, 123 may have an angle with the horizon that is less than or more than 90 degrees (i.e., an angle with either substantially horizontal members 132, 133 or substantially horizontal members 142, 143 that is less than 90 degrees). Support leg 122, shown on the left in FIG. 5 A, has a top end portion and support leg 123, shown on the right in FIG. 5A, has a top end portion. Substantially horizontal segments 132, 133 connect to support legs 122, 123, respectively, proximate the noted top end portions, respectively. As shown, substantially horizontal segments 132, 133 extend frontwards or in a frontward direction from their connections to respective support leg 122, 123. In at least one embodiment, substantially horizontal segments 132, 133 are substantially parallel to each other. However, in one or more other embodiments (not shown), substantially horizontal segments 132, 133 may extend closer to each other as they extend in a frontward direction to terminate proximate frontward end portions. In one embodiment (not shown), the substantially horizontal segments 132, 133 may meet and connect at their frontward end portions, thereby defining a triangular top section 60 (FIG. 3).

[0041] Each of the support legs 122, 123 also has a bottom end portion. Substantially horizontal foot segments 142, 143 connect to support legs 122, 123, respectively, proximate the noted bottom end portions, respectively. As shown, substantially horizontal foot segments 142, 143 extend frontwards or in a frontward direction from their connections to the respective support legs 122, 123. Each of the foot segments 142, 143 have a frontward foot segment end portion that may include, e.g, an end cap. In at least one embodiment, substantially horizontal foot segments 142, 143 are substantially parallel to each other. However, in one or more other embodiments (not shown), substantially horizontal foot segments 142, 143 may extend closer to each other as they extent frontwards to terminate proximate frontward foot segment end portions. Each of the support legs 122, 123 should be spaced apart a sufficient distance such that the upper body and/or head region of a patient may be positioned therebetween. Likewise, substantially horizontal foot segments 142, 143 should also be spaced apart a sufficient distance such that the foot segment 142, 143 may extend and/or run along the sides of the torso of a patient when the frame and a patient are disposed upon a support structure 80 (FIG. 3), such as a bed. In one or more embodiments, the spacing between each of the support legs 122, 123 and/or between each of the foot segments 142, 143 is at least 12 inches, at least 15 inches, at least 18 inches, at least 20 inches, at least 24 inches, at least 30 inches, or more. While the length of each of the horizontal segments 132, 133 is shown in FIG. 5A to be approximately the same, it will be understood to those skilled in the art that the length of the individual horizontal segments 132, 133 may be different relative to each other in the frontward direction. Likewise, the length of each of the foot segments 132, 133 is shown in FIG. 5A to be the same or approximately the same, but may have different relative lengths, especially in the frontward direction.

[0042] While the frame 10' of FIG. 5 A does not show the first and second brace members 52, 54 of frame 10 of FIG. 1A, frame 10' has brace members 164, 166, 168 that extend and connect between the support legs 122, 123 to provide stability to the support legs 122, 123 and horizontal segments 132, 133. Nevertheless, the first and/or second brace members 52, 54 of FIG. 1A may be similarly included in frame 10' to provide additional stability to the support legs 122, 123 and horizontal segments 132, 133. It should be noted that FIG. 5A illustrates the frame 10' in an assembled, unfolded, and ready to use condition whereas FIG. 5B illustrates the frame 10' in a folded condition for storage or transport. FIGS. 5C-5F illustrate the steps or procedures to fold frame 10' as viewed from the side. At FIG. 5C, the unfolded frame 10' is shown. In FIG. 5D, the horizontal segments 132, 133 are pivoted by their hinges up and over the support legs 122, 123 while the horizontal foot segments 142, 143 — hinged at the bottom end portions of support legs 122, 123 — are pivoted upwardly toward the support legs 122, 123. FIG. 5E shows the continued motion described in FIG. 5D. Finally, FIG. 5F shows the folded frame 10' in which the horizontal segments 132, 133 rest vertically on the rear side of the support legs 122, 123 and the horizontal foot segments rest vertically on the front side of the support legs 122, 123. It should be noted that the folding operation of frame 10' is slightly different than that of frame 10 as described above with reference to FIG. 4. However, the materials of construction (i.e., copper, metal, plastic, polypropylene, etc.) and the other configurations/considerations as disclosed above may be interchanged between the embodiments of FIG. 1A and 5 A.

[0043] As shown in FIG. 6, in one embodiment of a kit 90 for containing respiratory aerosols during endotracheal intubation procedures, the kit 90 includes an assembled frame 10, 10' that may be the embodiment of the frame 10 shown in FIG. 1 A , the embodiment of the frame 10' shown in FIG. 5A, or any embodiment of the frame disclosed herein, at least one plastic sheet or bag 70 having one or more edge portions that can be draped over the frame 10, 10' as disclosed herein, e.g ., to substantially surround the frame on all its top and sides; and an antiseptic solution 94 (e.g, in the form of disinfectant-saturated wipes or cloths, liquids in spray bottles, etc.) used to disinfect outer surfaces of the frame 10, 10' between uses of the frame 10, 10'. In one or more embodiments, the kit 90 may include a kit container 92, such as a bag or box, to store or transport between uses the frame 10, 10' (whether assembled or disassembled), a container or box 72 containing plastic sheets or bags 70 (e.g, one or more, a plurality, a set of similar or a set of different plastic coverings), and a container or box 96 of antiseptic solution wipes 94 or liquid disinfection solution (not shown). In an embodiment, the kit 90 includes the respiratory aerosol containment frame in a folded configuration, as previously disclosed (see, e.g, FIG. 5B). In one or more embodiments, the kit may contain the frame in an unassembled state.

[0044] In the drawings and specification, several embodiments of the Respiratory Aerosol Containment Apparatus, Kit, and Associated Methods have been disclosed, and although specific terms are employed, the terms are used in a descriptive sense only and not for purposes of limitation. Embodiments of these apparatuses, kits, and methods have been described in considerable detail with specific reference to the illustrated embodiments. However, it will be apparent that various modifications and changes can be made within the spirit and scope of the embodiments of the apparatuses, kits, and methods as described in the foregoing specification, and such modifications and changes are to be considered equivalents and part of this disclosure.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A respiratory aerosol containment apparatus comprising: a frame having two spaced apart, rearward support legs, each of the support legs being substantially vertical and having a top end portion with a substantially horizontal segment connected thereto and extending outwardly in a frontward direction from the top end portion, each support leg also having a bottom end portion with a substantially horizontal foot segment connected thereto and extending outwardly in a frontward direction from the bottom end portion, the horizontal segments having frontward end portions and a substantially horizontal first brace member connected thereto and extending laterally therebetween proximate the frontward end portions, the horizontal segments also having a substantially horizontal second brace member connected thereto and extending laterally therebetween proximate the top end portions of the support legs, the horizontal segments and first and second brace members defining a top section of the frame, each of the foot segments having a longer horizontal length than each of the horizontal segments; and a plastic covering positioned over the top section of the frame and extending downwardly along each side of the frame.

2. The respiratory aerosol containment apparatus of claim 1, wherein the frame is constructed at least partially of copper.

3. The respiratory aerosol containment apparatus of claim 1, wherein the frame is constructed at least partially of copper tubing.

4. The respiratory aerosol containment apparatus of claim 1, wherein the frame is constructed at least partially of polypropylene.

5. The respiratory aerosol containment apparatus of claim 1, wherein the frame is constructed at least partially of polypropylene tubing.

6. The respiratory aerosol containment apparatus of claim 1, wherein the plastic covering has a plurality of edge portions with one edge portion that extends to a position below one of the foot segments and another edge portion that extends to another position below another of the foot segments.

7. The respiratory aerosol containment apparatus of claim 1, wherein at least portion of the plastic covering is tucked underneath at least one of the foot segments.

8. A method of containing respiratory aerosol during endotracheal intubation procedures, the method comprising: positioning a frame on a support structure proximate an upper body of a patient when the patient lies in a substantially horizontal position upon the support structure, the frame having two spaced apart, rearward support legs, each of the support legs being substantially vertical and having a top end portion with a substantially horizontal segment connected thereto and extending outwardly in a frontward direction from the top end portion, each support leg also having a bottom end portion with a substantially horizontal foot segment connected thereto and extending outwardly in a frontward direction from the bottom end portion, the horizontal segments having frontward end portions and a substantially horizontal first brace member connected thereto and extending laterally therebetween proximate the frontward end portions, the horizontal segments also having a substantially horizontal second brace member connected thereto and extending laterally therebetween proximate the top end portions of the support legs, the horizontal segments and first and second brace members defining a top section of the frame, each of the foot segments having a longer horizontal length than each of the horizontal segments, the frame being positioned with the top section above the upper body of the patient and the foot segments extending along the support structure on either side of the patient toward a lower body of the patient when the patient lies in the substantially horizontal position upon the support structure, positioning a plastic covering having one or more edge portions over the top section of the frame, permitting the one or more edge portions of the plastic covering to extend downwardly along each side of the frame, with at least a portion of the one or more edge portions extending vertically downwardly below the horizontal position of the patient when the patient lies in the substantially horizontal position upon the support structure, and maintaining the frame as positioned for a period of time that extends from a time before to another time after an endotracheal intubation procedure is performed upon the patient while the patient lies in a substantially horizontal position upon the support structure.

9. The method of claim 8, further comprising tucking the at least a portion of the one or more edge portions underneath the patient when the patient lies in the substantially horizontal position upon the support structure.

10. The method of claim 8, further comprising tucking the at least a portion of the one or more edge portions underneath at least one of the foot segments.

11. The method of claim 8, further comprising removing and disposing of the plastic covering after the period of time has elapsed.

12. The method of claim 11, further comprising removing the frame from proximate the upper body of the patient.

13. The method of claim 12, further comprising disinfecting outer surfaces of the frame with a disinfecting solution.

14. The method of claim 13, further comprising positioning the frame on another support structure proximate an upper body of another patient when the another patient lies in a substantially horizontal position upon the another support structure.

15. The method of claim 12, further comprising disassembling or folding the frame.

16. The method of claim 8, wherein the frame is constructed at least partially of copper.

17. The method of claim 8, wherein the frame is constructed at least partially of copper tubing.

18. The method of claim 8, wherein the frame is constructed at least partially of polypropylene.

19. The method of claim 8, wherein the frame is constructed at least partially of polypropylene tubing.

20. A kit for containing respiratory aerosols during endotracheal intubation procedures, the kit comprising: a disassembled frame, the frame when assembled having two spaced apart, rearward support legs, each of the support legs being substantially vertical and having a top end portion with a substantially horizontal segment connected thereto and extending outwardly in a frontward direction from the top end portion, each support leg also having a bottom end portion with a substantially horizontal foot segment connected thereto and extending outwardly in a frontward direction from the bottom end portion, the horizontal segments having frontward end portions and a substantially horizontal first brace member connected thereto and extending laterally therebetween proximate the frontward end portions, the horizontal segments also having a substantially horizontal second brace member connected thereto and extending laterally therebetween proximate the top end portions of the support legs, the horizontal segments and first and second brace members defining a top section of the frame, each of the foot segments having a longer horizontal length than each of the horizontal segments; at least one plastic sheet having one or more edge portions, the at least one plastic sheet arranged and designed to be positioned over the top section of the assembled frame and extend downwardly along each side of the assembled frame; and a disinfecting solution used to disinfect outer surfaces of the assembled frame between uses thereof.

21. The kit of claim 20, wherein the frame is constructed at least partially of copper.

22. The kit of claim 20, wherein the frame is constructed at least partially of copper tubing.

23. The kit of claim 20, wherein the frame is constructed at least partially of polypropylene.

24. The kit of claim 20, wherein the frame is constructed at least partially of polypropylene tubing.

25. The kit of claim 20, wherein at least one of the one or more edge portions is arranged and designed to extend to a position below one of foot segments when the plastic sheet is positioned over the top section of the frame.

26. The kit of claim 20, further including a container to store the disassembled frame, the at least one plastic sheet and the disinfecting solution between uses.

27. The kit of claim 20, wherein the at least one plastic sheet is a plurality of sheets.