Vacuum shield assemblies for attachment to medical masks and intubation assemblies for protection against airborne diseases

Abstract

A vacuum shield assembly and associated systems and methods are intended for attachment to existing medical masks for air aspiration, nebulization, BIPAP, and / or CPAP. An intubation assembly, shield assembly, and associated systems and methods are configured to at least partially reduce the risk of airborne disease transmission. The vacuum shield assembly includes a shield body and a retention assembly. The retention assembly can attach the vacuum shield assembly to the vacuum tube of an existing medical mask. The retention assembly can attach to a nebulizer unit or an oxygen supply tube of the medical mask. The intubation assembly includes an intubation device assembly, which can include an intubation device such as a laryngoscope, endoscope, bronchoscope, or other fiber optic device. The shield assembly includes a body having multiple side segments and a first transparent component in which a shield opening is located.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION This invention relates to attachments to masks for medical procedures and protective shields for intubation, endoscopy, bronchoscopy, or other procedures that may generate aerosols or respiratory pathogens. [Background technology]

[0002]

[0002] Medical masks are used for or are intended for nebulizing a patient or can be used for non-invasive positive pressure ventilation (NIPPV), bilevel positive airway pressure (BIPAP), bag-valve-mask ventilators (BVM), demand-valve ventilators (DVR), or continuous positive airway pressure (CPAP). None of the currently existing masks is believed to provide a truly efficient means for drawing air to generate negative pressure or for using negative pressure to draw exhaled air from a patient while simultaneously performing nebulization or positive pressure therapy. Therefore, the industry would benefit from providing a vacuum shield assembly for attachment to a medical mask that can be used to draw exhaled air from a patient during nebulization, BIPAP, CPAP, or oxygen delivery. Such vacuum shield assemblies offer the added benefit of at least partially reducing contact with the patient's mask and / or face, which helps combat the risk of transmission of airborne diseases such as influenza, COVID-19, etc., provides additional protection for healthcare providers and staff involved in these procedures, and at least partially reduces the generation of fomite particles from exhaled or aerosolized particles or droplets. Furthermore, if such vacuum shield assemblies are disposable, they further reduce the risk of such transmission, thereby providing an industry benefit. Still further advantages are provided if such a vacuum shield assembly is versatile enough to be used as a primary and / or secondary air vacuum component and / or a nebulizing component. Still further advantages are realized if the vacuum shield assembly is provided in different shapes and sizes to correspond to the geometry and size of the underlying face mask.

[0003] Furthermore, the spread of airborne diseases poses serious health risks not only to individuals in the community but also to healthcare workers. This is relevant for patients suffering from airborne diseases, such as influenza and, more recently, respiratory illnesses such as COVID-19. Such sick patients may require healthcare workers to perform procedures, such as intubation, endoscopy, bronchoscopy, or other procedures, particularly those requiring fiber optic devices. During the process of performing the procedure, healthcare workers may be at risk for transmission of airborne diseases. Therefore, an advantage is realized by providing an intubation assembly that can function as a shield over the sick patient's face. Ideally, such an intubation assembly would allow healthcare workers to insert a laryngoscope, endoscope, bronchoscope, or other fiber optic device through the shield. Another advantage is realized if the intubation assembly also allows healthcare workers to insert an endotracheal tube through the shield. Yet a further advantage is realized if the shield includes a substantially transparent material that allows visibility of the patient and the intubation area. Yet further advantages are realized if such an intubation assembly is provided with various operating components that can be connected to a vacuum system to provide a negative pressure that can at least partially remove exhaled air from the patient. Another advantage is realized if such a shield assembly is provided as a stand-alone component that can be used alone, without being tied to a system, to protect other people and the environment from particles in the patient's exhaled air. Summary of the Invention

[0004] I. Vacuum shield assembly for attachment to a medical mask

[0005] The present invention relates to a vacuum shield assembly intended to be attached to an existing mask. As used herein, "existing mask" refers to a suction mask, a mask configured to attach to a nebulizer, a BIPAP, CPAP, BVM, DVR, or another related mask already placed on a patient's head and / or face, including a mask configured for oxygen delivery to a patient. Thus, in some embodiments, the vacuum shield assembly of the present invention can function as a primary and / or secondary suction or vacuum mechanism that can be connected to a negative pressure vacuum. The vacuum shield assembly generally comprises a shield body and a retention assembly. The retention assembly can be used to connect the vacuum shield to a vacuum tube connected to a negative pressure vacuum. The retention assembly can also be attached to a nebulizer unit or component thereof, or the oxygen delivery tube of a BIPAP or CPAP mask. Furthermore, the shield body can comprise a lower segment. The shield body can be configured with or without a circular access opening in the convex portion of the shield body, which allows a BVM or DVR to connect to the existing mask through the access opening to facilitate drawing a vacuum during exhalation during the procedure. The lower segment can further define an interior or inner portion of the shield body and can include a connection portion disposed in fluid communication with the retention assembly and the vacuum tube. The shield body can be configured and dimensioned to accommodate existing mask geometries. By way of example, the shield body can have a variety of shapes, including, but not limited to, a substantially concave shape and / or a substantially triangular or substantially oval shape. However, other shield body shapes are possible that can accommodate existing mask shapes and / or patient face and / or head shapes. Thus, it is within the scope of the present invention for a vacuum shield assembly according to the present invention to at least partially remove infectious particles in exhaled breath, for example, from a patient with a respiratory disease.As a result, such increased removal of infectious particles in exhaled breath is thought to, at least in part, reduce the risk of infection for healthcare workers and staff assisting with these types of procedures and / or contamination of nearby physical objects (fomites).

[0005]

[0006] Further embodiments of the present invention include systems configured to remove exhaled air from a patient wearing a medical mask. In such embodiments, a portable vacuum unit may be provided, which itself connects to a vacuum shield assembly, i.e., a vacuum tube that connects to the shield body, to create negative pressure within the shield body and remove exhaled air. The innovative system may include a retention assembly if it is desired to connect to an existing medical mask component, or may not include a retention assembly in embodiments where it is desired to place the shield body directly on the patient's face.

[0006]

[0007] II. Intubation Assembly for Protection Against Airborne Diseases

[0008] The present invention relates to an intubation assembly and a shield assembly that can at least partially reduce the risk of airborne disease transmission, including the risk of airborne disease transmission from a patient to a healthcare professional, i.e., a doctor, nurse, assistant, etc. The present invention also relates to a method of using the intubation assembly of the present invention. The intubation assembly and shield assembly of the present invention at least partially reduce the exposure of healthcare professionals and others to infectious particles in exhaled breath, such as viruses and bacteria. The intubation assembly and shield assembly of the present invention at least partially provides protection against infectious particles in exhaled breath. Therefore, the intubation assembly of the present invention can be used as a standalone component, i.e., without being tied to a system capable of providing oxygen supply, air suction, or nebulization therapy, thereby protecting the environment surrounding the patient from the spread of contaminating particles in exhaled breath. Furthermore, the intubation assembly and shield assembly of the present invention can provide at least a partial seal between a laryngoscope, endoscope, bronchoscope, or other fiber optic device and a patient at the location where it is fitted and / or inserted. Furthermore, the intubation assembly and shield assembly of the present invention can also provide at least a partial seal in the area where an endotracheal tube is inserted or otherwise passed. Such configurations of the intubation and shield assemblies, including the geometry of the shield body, can substantially define an operable configuration in conjunction with a negative pressure vacuum. Thus, when positioned in such an operable configuration, the intubation and shield assemblies according to the present invention can at least partially remove exhaled breath from a patient, thereby protecting medical personnel involved in a procedure by at least partially reducing exposure to infectious particles in the exhaled breath.

[0007]

[0009] Further embodiments of the present invention include systems configured to remove exhaled air from a patient in connection with an intubation or other related procedure. In such embodiments, a portable vacuum unit may be provided, which itself may be connected to a vacuum tube that connects to the shield assembly, i.e., the shield body, to generate negative pressure within the shield body and remove exhaled air. The innovative system may be provided with a shield body that can be placed around the patient's facial area to perform the intubation procedure through the patient's mouth. Alternatively, the innovative system may include a shield body that can be placed around the patient's neck area to perform the intubation procedure around an opening in the patient's neck area.

[0008]

[0010] The intubation assembly includes an intubation device assembly and a shield assembly. The intubation device assembly can be operably disposed on the shield assembly. The shield assembly is typically connected to a negative pressure vacuum or other vacuum system. The intubation device assembly can include an intubation device, including, but not limited to, a laryngoscope, an endoscope, a bronchoscope, or other fiber-optic device. The intubation device can be placed on a sleeve of corresponding dimensions on the intubation device assembly. The sleeve should have a geometric shape that allows it to be held by a medical professional. The shield assembly includes a body having multiple side segments. The shield assembly can also include a first transparent component having a shield opening disposed therein. The shield opening can be used for insertion of the laryngoscope assembly. By way of example, the first transparent component can include a transparent silicone sheet having an opening disposed therein. The shield assembly can also include a second transparent component having at least one longitudinally disposed slot for insertion of an endotracheal tube, and in some embodiments, an endoscope, a bronchoscope, or other fiber-optic device. [Brief explanation of the drawings]

[0009] [Figure 1]FIG. 1 is a perspective view of one embodiment of a vacuum shield assembly according to the present invention attached to a nebulizer mask. [Figure 2] FIG. 10 is a perspective view of another embodiment of a vacuum shield assembly according to the present invention for use with a nebulizer mask. [Figure 3] FIG. 10 is a perspective view of yet another embodiment of a vacuum shield assembly according to the present invention for use with a nebulizer mask. [Figure 4] FIG. 10 is a partially exploded perspective view of a further embodiment of a vacuum shield assembly according to the present invention. [Figure 5] 1 is a perspective view of one embodiment of a retention assembly of a vacuum shield assembly according to the present invention; [Figure 6] 1 is a perspective view of one embodiment of a vacuum shield assembly according to the present invention attached to a BIPAP or CPAP mask. FIG. [Figure 7] 1 is a perspective view of another embodiment of a vacuum shield assembly according to the present invention for use with a BIPAP or CPAP mask. FIG. [Figure 8] FIG. 10 is a perspective view of yet another embodiment of a vacuum shield assembly according to the present invention for use with a BIPAP or CPAP mask. [Figure 9] FIG. 10 is a partially exploded perspective view of yet a further embodiment of a vacuum shield assembly according to the present invention. [Figure 10] 10 is a perspective view of yet a further embodiment of a vacuum shield assembly according to the present invention; [Figure 11] 10 is a perspective view of another embodiment of a retention assembly of a vacuum shield assembly according to the present invention. [Figure 12] 1 is a perspective view of one embodiment of a shield body of a vacuum shield assembly according to the present invention, the shield body including a second opening. [Figure 12A] 1 is a perspective view of one embodiment of a shield body of a vacuum shield assembly according to the present invention, the shield body including a second opening. [Figure 12B]10 is a perspective view of another embodiment of a shield body of a vacuum shield assembly according to the present invention, the shield body including a second opening. [Figure 12C] 10 is a perspective view of yet another embodiment of a shield body of a vacuum shield assembly according to the present invention, the shield body including a second opening. [Figure 12D] 10 is a perspective view of yet another embodiment of a shield body of a vacuum shield assembly according to the present invention, the shield body including a second opening and connected to a BVM or DVR unit. FIG. [Figure 13A] 1 is a perspective view of one embodiment of a shield body of a vacuum shield assembly according to the present invention, including a vacuum attachment disposed on the shield body. [Figure 13B] 10 is a perspective view of another embodiment of a shield body of a vacuum shield assembly according to the present invention, including a vacuum attachment disposed on the shield body. [Figure 14A] FIG. 10 is a perspective view of yet another embodiment of a shield body of a vacuum shield assembly according to the present invention, including a vacuum attachment disposed on the shield body. [Figure 14B] 10 is a perspective view of yet a further embodiment of a shield body of a vacuum shield assembly according to the present invention, the shield body including a vacuum attachment disposed on the shield body. [Figure 15A] 1 is a perspective view of one embodiment of a shield body of a vacuum shield assembly according to the present invention, with a vacuum attachment disposed on the shield body and connected to a BVM or DVR unit. FIG. [Figure 15B] 10 is a perspective view of another embodiment of a shield body of a vacuum shield assembly according to the present invention, with a vacuum attachment disposed on the shield body and connected to a BVM or DVR unit. FIG. [Figure 16A] FIG. 2 is a top view of one embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. [Figure 16B] FIG. 10 is a top view of another embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. [Figure 16C]10 is a top view of a further embodiment of a vacuum attachment in accordance with the vacuum shield assembly of the present invention. FIG. [Figure 16D] FIG. 10 is a top view of yet another embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. [Figure 16E] 10 is a top view of yet a further embodiment of a vacuum attachment in accordance with the vacuum shield assembly of the present invention. FIG. [Figure 16F] FIG. 10 is a top view of another embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. [Figure 16G] 10 is a top view of a further embodiment of a vacuum attachment in accordance with the vacuum shield assembly of the present invention. FIG. [Figure 16H] 10 is a top view of yet a further embodiment of a vacuum attachment in accordance with the vacuum shield assembly of the present invention. FIG. [Figure 16I] FIG. 10 is a top view of yet another embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. [Figure 17] 1 is a perspective view of one embodiment of a system according to the present invention; [Figure 18A] 1 is a perspective view of one embodiment of a system according to the present invention with components separated; FIG. [Figure 18B] FIG. 10 is a perspective view of another embodiment of a system according to the present invention. [Figure 19A] FIG. 1 is a perspective side view of one embodiment of a shield body and retention assembly of a system according to the present invention. [Figure 19B] FIG. 10 is a perspective side view of another embodiment of a shield and retention assembly of a system according to the present invention prior to attachment to a nebulizer. [Figure 19C] FIG. 10 is a perspective side view of yet another embodiment of a shield and retention assembly of a system according to the present invention attached to a nebulizer. [Figure 19D] FIG. 10 is a perspective side view of a further embodiment of a shield and retention assembly of a system according to the present invention positioned over an existing medical mask attached to a patient. [Figure 20A]FIG. 1 is a perspective side view of one embodiment of a shield body and retention assembly of a system according to the present invention. [Figure 20B] FIG. 10 is a perspective side view of another embodiment of a shield and retention assembly of a system according to the present invention prior to attachment to an oxygen delivery tube. [Figure 20C] FIG. 10 is a perspective side view of yet another embodiment of a shield and retention assembly of a system according to the present invention attached to an oxygen delivery tube. [Figure 20D] FIG. 10 is a perspective side view of a further embodiment of a shield and retention assembly of a system according to the present invention positioned over an existing medical mask attached to a patient. [Figure 21A] FIG. 1 is a perspective view of a portion of one embodiment of a system according to the present invention, including a strap for an existing mask and a retention assembly attached to a nebulizer. [Figure 21B] FIG. 10 is a perspective view of a portion of another embodiment of a system according to the present invention, including a strap for an existing mask and a retention assembly attached to a nebulizer. [Figure 21C] FIG. 10 is a perspective view of a portion of yet another embodiment of a system according to the present invention, including a strap for an existing mask and a retention assembly attached to a nebulizer. [Figure 21D] FIG. 1 is a perspective view of one embodiment of a system according to the present invention comprising a body shield attached to a medical mask and a patient. [Figure 22] 1 is a schematic diagram of one embodiment of a method according to the present invention for removing exhaled air from a patient; [Figure 23A] FIG. 1 is a perspective view of one embodiment of an intubation assembly according to the present invention. [Figure 23B] FIG. 10 is a perspective view of another embodiment of an intubation assembly according to the present invention. [Figure 23C] FIG. 10 is a perspective view of yet another embodiment of an intubation assembly according to the present invention. [Figure 23D] 1 is a perspective view of one embodiment of a shield assembly according to the present invention; [Figure 24]FIG. 1 is a perspective view of one embodiment of a laryngoscope assembly of an intubation assembly according to the present invention. [Figure 25] FIG. 1 is a perspective view of one embodiment of a shield assembly of an intubation assembly according to the present invention. [Figure 26] FIG. 10 is a perspective view of another embodiment of a shield assembly of an intubation assembly according to the present invention being operated by a user. [Figure 27] FIG. 1 is a side view of one embodiment of a shield assembly of an intubation assembly according to the present invention being operated by a user. [Figure 28] FIG. 10 is a side view of another embodiment of a shield assembly of an intubation assembly according to the present invention being operated by a user. [Figure 29] FIG. 10 is a side view of yet another embodiment of a shield assembly of an intubation assembly according to the present invention being operated by a user. [Figure 30] FIG. 1 is a side view of an intubated patient with the intubation assembly removed. [Figure 31] FIG. 12 is a perspective view of one embodiment of a shield assembly of an intubation assembly according to the present invention, including an offset structure. [Figure 32] FIG. 1 is a front view of one embodiment of a shield assembly of an intubation assembly according to the present invention, including an offset structure and operably positioned on a patient's head. [Figure 33] 1 is a schematic diagram of one embodiment of a method of using an intubation assembly in accordance with the present invention. [Figure 34] 1 is a perspective view of one embodiment of a system according to the present invention; [Figure 35] 1 is a perspective view of one embodiment of a system according to the present invention with components separated; FIG. [Figure 36A] FIG. 2 is a perspective side view of one embodiment of a shield body of a system according to the present invention. [Figure 36B] FIG. 2 is a perspective side view of one embodiment of a shield body, sleeve, and vacuum tube of a system according to the present invention. [Figure 36C]FIG. 10 is a perspective side view of another embodiment of a shield body, sleeve, and vacuum tube according to the present invention. [Figure 36D] FIG. 10 is a perspective side view of yet another embodiment of a shield body, sleeve, and vacuum tube according to the present invention. [Figure 36E] 10 is a perspective view of a further embodiment of a shield body, sleeve, and vacuum tube according to the present invention. FIG. [Figure 36F] 1 is a perspective view of an intubated patient using a system according to the present invention; [Figure 37A] FIG. 2 is a top view of one embodiment of a shield body of a system according to the present invention. [Figure 37B] FIG. 1 is a perspective view of a portion of one embodiment of a system according to the present invention, including a strap disposed on a shield body. [Figure 37C] FIG. 10 is a perspective view of a portion of another embodiment of a system according to the present invention, including a strap disposed on the shield body. [Figure 37D] FIG. 10 is a perspective view of a portion of yet another embodiment of a system according to the present invention, including a strap disposed on the shield body. [Figure 37E] FIG. 10 is a perspective view of a portion of a further embodiment of a system according to the present invention, comprising a strap disposed on the shield body. [Figure 38A] FIG. 1 is a perspective view of one embodiment of a shield body of a system according to the present invention. [Figure 38B] FIG. 10 is a perspective view of another embodiment of a shield body of a system according to the present invention positioned on a patient's head. [Figure 38] FIG. 1 is a perspective view of a patient with an opening around the neck region. [Figure 39] FIG. 1 is a perspective view of one embodiment of a shield body according to the system of the present invention. [Figure 40] FIG. 10 is a perspective view of another embodiment of a shield body according to the system of the present invention. [Figure 41] 1 is a schematic diagram of one embodiment of a method according to the present invention for removing exhaled air from a patient; DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0090] I. Vacuum shield assembly for attachment to medical masks

[0091] Referring initially to FIGS. 1-4, 6-10, and 12, the present invention relates to a vacuum shield assembly 10. The vacuum shield assembly 10 according to the present invention is intended to be placed on the head and / or face of a patient already wearing a medical mask and is intended to at least partially extract exhaled air from the patient. For example, as perhaps best shown in FIGS. 1 and 6, the vacuum shield assembly 10 can be attached to a mask already placed on the patient's head and / or face. The vacuum shield assembly 10 can be connected to a vacuum tube, for example, between the already placed medical mask and the interior of the shield body 11 of the vacuum shield assembly 10, so that exhaled air can be at least partially extracted from the patient. The vacuum shield assembly 10 can function as a primary suction or vacuum mechanism or as a secondary suction or vacuum mechanism. By way of example, as shown in FIGS. 6-8, the vacuum shield assembly 10 can be attached to a BIPAP mask, a CPAP mask, and / or a mask configured to provide oxygen delivery to the patient already placed on the patient's head and / or face. Other possible existing medical masks that may be used in connection with the present invention include face masks, face tents, venture masks, and / or non-rebreathers. As a further example, as shown in Figures 1-3, the vacuum shield assembly 10 may be attached to a nebulizing mask already positioned on the patient's head and / or face.

[0011]

[0092] As shown in at least the exemplary embodiments of FIGS. 1-4, 6-10, and 12, the vacuum shield assembly 10 includes a shield body 11. The vacuum shield assembly 10 also generally includes a retention assembly 20. The retention assembly 20 generally connects the shield body 11 to a vacuum tube. As used herein, the term "vacuum tube" refers to a conduit, hose, or other related structure that can carry air from a patient and / or mask to another location and connect to a negative pressure vacuum. For example, the vacuum tube 40 can include a 22-millimeter hose that can have a length of approximately 8 feet. As shown in at least FIGS. 2 and 7, the retention assembly 20 can be used to interconnect the shield body 11 to the vacuum tube. The structure of the retention assembly 20 should define fluid communication between the interior of the shield body 11 and the vacuum tube. Thus, the shield body 11 can generate a negative pressure therein to remove air between the medical mask, the patient's face and / or head, and the interior of the shield body 11. It is contemplated that a patient wearing a BIPAP or CPAP mask, or a nebulizing mask, may exhale through the mask and at least a portion of this exhaled air may be captured by the negative pressure created by the shield body 11 and the vacuum tube.

[0012]

[0093] As shown in FIGS. 1-2 and 6-7, a holding assembly 20 can also be used to connect the shield body 11 and / or the vacuum tube to the oxygen supply tube and / or the nebulizing unit or components thereof. Shield bodies of different sizes can be attached to the holding assembly 20, for example, by inserting the connecting portion 18 into the upper section 21″ of the holding component 21, or can be attached directly to the holding component 21, as described below. Thus, it may be possible to switch between different sized shield bodies according to specific needs, e.g., air suction, nebulization therapy, etc., and / or geometric constraints, e.g., the size of the patient's head.

[0013]

[0094] 12A-15B, the shield body 11 of the vacuum shield assembly 10 of the present invention can be provided with a second opening 16 configured and dimensioned to accommodate a medical mask. With particular reference to FIGS. 12B-12D and 14A-15B, the second opening 16 can be configured and dimensioned so that a connection segment of an existing medical mask, such as a demand-valve respirator (DVR) mask or a bag-valve-mask (BVM) respirator mask, can be inserted through the second opening 16, as shown, for example, in FIGS. 12D, 15A, and 15B. Additionally, the shield body 11 may be provided with a vacuum attachment 17 that may at least partially define or otherwise form a seal between the outer surface 11' and the inner surface 11" of the shield body 11. Also, the second opening 16 and / or the vacuum attachment 17 may be configured and dimensioned to be operable to substantially define a seal between the second opening 16 and the connection segment of the medical mask. Thus, the vacuum attachment 17 may comprise a grommet component or grommet seal. However, this is not necessarily limiting, as other configurations of the vacuum attachment 17 are possible.

[0014]

[0095] As shown in at least FIG. 15A, the grommet seal can be co-molded to the shield body 11. This is advantageous because it can at least partially reduce the time, effort, and / or cost associated with manufacturing the vacuum shield assembly 10 with the vacuum attachment. Furthermore, a grommet seal co-molded to the shield body can provide a robust structure, which is also advantageous. Alternatively, as shown in at least FIG. 15B, the grommet seal can be inserted into the shield body, which is known as insert molding. Furthermore, the vacuum attachment 17 can comprise a variety of materials, including, but not necessarily limited to, silicone, rubber, plastic, elastomeric polymers, seals, sealants, and / or other related structures. Thus, the second opening 16 can at least partially allow operative communication between the existing mask, i.e., BVM or DVR, and the underlying BVM or DVR unit through the interior of its connecting segment. It is believed that the opening 16 allows at least fluid communication between the existing mask and the BVM or DVR unit, i.e., through the interior of the mask's connecting segment passing through the second opening 16.

[0015]

[0096] Referring again to FIGS. 12A-15B, the second opening 16 can be positioned on the shield body 11 at a location corresponding to that of a medical mask. During some BVM and / or DVR procedures, some air may leak between the patient's face and the mask attached to the patient, for example, when the patient inhales or exhales. In such BVM and / or DVR procedures, the vacuum shield assembly 10 of the present invention is intended to capture exhaled air that may leak from the BVM and / or DVR mask. Therefore, the second opening 16 can be positioned approximately around the midsection of the shield body 11 and / or above the first opening 13. This allows the vacuum shield assembly 10 to be installed at a location corresponding to the location of the connection segment of a medical mask. Furthermore, the second opening 16 and / or the vacuum attachment 17 can be positioned at a height along the shield body 11 that roughly corresponds to the location of an existing medical mask. 15A and 15B, exhaled air can exit through opening 13 in the existing mask, i.e., shield body 11. Additionally or alternatively, exhaled air can also exit through a vacuum tube operatively connected to the existing mask and connection segment and passing through second opening 16.

[0016]

[0097] As perhaps best shown in Figures 16A-16I, a feature of the present invention includes providing a vacuum attachment 17 with a grommet configuration. As shown in Figures 16A-16I, the vacuum attachment 17 can have a substantially circular shape configured to correspond to the diameter and / or size of the second opening 16. For example, the diameter of the outer periphery or recess of the vacuum attachment 17 can be configured to correspond to the dimension and / or size of the second opening 16. Furthermore, the circular shape of the vacuum attachment 17 can be configured and dimensioned to correspond to the diameter and / or size of the connection segment of a medical mask, for example, around the inner periphery of the vacuum attachment 17. As shown in Figures 16F and 16I, a vacuum attachment 17 can be provided that includes a grommet configuration with an aperture. 16A-16E and 16G-16H, the vacuum attachment can include a grommet configuration that forms a cover around the inner periphery of the vacuum attachment 17. The cover can include a plurality of adjacently arranged segments 17′ that can be collectively configured to form a substantially flat surface in a non-operating configuration of the connecting segments of the medical mask, i.e., when the connecting segments are not inserted around the second opening 16. The plurality of adjacently arranged segments 17′ can be collectively configured to bend at least in a direction opposite to the movement of the connecting segments of the medical mask.

[0017]

[0098] As shown in the exemplary embodiment of FIGS. 15A and 15B , when a connecting segment of a medical mask is inserted through the second opening 16, the multiple adjacently arranged segments 17′ can bend toward the outer surface 11′, allowing the connecting segment to pass through the second opening 16. Conversely, when the connecting segment is removed, the multiple adjacently arranged segments 17′ can return to their natural and / or initial positions and again form a cover around the aperture of the vacuum attachment 17. Thus, a vacuum shield assembly 10 according to the present invention can be used in connection with a single BVM and / or DVR procedure, then removed and used in a subsequent BVM and / or DVR procedure. The vacuum shield assembly 10 can also be used in connection with a procedure that uses the second opening 16, i.e., a BVM and / or DVR procedure, and then used in a subsequent procedure that does not use the second opening 16, or vice versa. Alternatively, a vacuum shield assembly 10 with a second opening 16 can be used in connection with a procedure that does not require the second opening 16. Therefore, the vacuum shield assembly 10 with the second opening 16 can be attached to a medical mask that is neither a BMV mask nor a DVR mask. Therefore, the plurality of adjacently arranged segments 17' can naturally and essentially form a cover that acts as a seal between the outer surface 11' and the inner surface 11". In other words, the plurality of adjacently arranged segments 17', in their natural positions, should at least partially reduce leakage of exhaled air from the inner surface 11" to the outer surface 11'. Therefore, exhaled air is retained inside the shield body 11 and can be removed via the connecting portion 18 and / or the oxygen tube.

[0018]

[0099] As also seen in Figures 16A-16E and 16G-16H, each of the plurality of adjacently arranged segments 17' can have a substantially triangular shape. Thus, when positioned around the inner periphery of the vacuum attachment 17, they can substantially define a cover. For example, the plurality of adjacently arranged segments 17' having a substantially triangular shape can include four segments, e.g., in Figure 16D, six segments, e.g., in Figure 16G, eight segments, e.g., in Figures 16A, 16B, 16C, 16E, and 16H, or even more than eight segments. Furthermore, as shown in Figure 16H, the plurality of adjacently arranged segments 17' can include reinforcing ribs. The exemplary embodiments of Figures 16D-16E and 16G can also include a flush upper relief ring or recessed pocket, as shown in Figures 16C-16H. As shown in Figures 16A-16B, another possible configuration of multiple adjacently disposed segments includes a flush top configuration without a relief ring.

[0019]

[0100] As perhaps best shown in FIGS. 5-6 and as described below, the vacuum shield assembly 10 of the present invention includes a retention assembly 20. As shown in FIGS. 1 and 6, the retention assembly 20 can be oriented toward the patient's face so that it can be used to attach the shield body 11 to existing vacuum tubing or other related components. Various connection mechanisms for the retention assembly 20 can be implemented to connect the shield body 11, vacuum tubing, oxygen delivery tubing, or nebulizing unit. In other words, the retention assembly 20 can be used to interconnect the shield body 11 to vacuum tubing and oxygen delivery tubing, existing nebulizing units and / or masks, or existing BIPAP or CPAP masks. By way of example, the retention assembly 20 can include a clamp or connecting arm. Other mechanisms for the retention assembly 20 are within the scope of the present invention and may include adhesives, connecting bands, snap-fit ​​mechanisms, magnets, or another related connection mechanism.

[0020]

[0101] As seen in the exemplary embodiment of FIGS. 5 and 11 , the retention assembly 20 can include a retention frame 23 connected to the retention component 21. As discussed above, the connecting portion 18 of the vacuum shield assembly 10 can be configured and dimensioned to correspond to the size of the retention component 21 of the retention assembly 20. As can be seen from FIG. 11 , it may be beneficial to provide height adjustment of the connection point between the connecting portion 18 of the shield body 11 and the retention assembly 20. In such an embodiment, the retention component 21 can be provided with an upper section 21″ that can at least partially elevate the position of the shield body 11 relative to the attachment point of the retention assembly 20 to the oxygen delivery tube or other associated component of an existing mask.

[0021]

[0102] A further feature of the present invention includes providing a shield body 11 that can be configured and dimensioned to correspond to the geometry and / or size of a patient's head and / or face and / or an existing mask and its components. It is within the scope of the present invention for a substantial portion of the edge 12 to at least partially surround the existing mask when the shield body 11 is placed against the existing mask. That is, the shield body 11, including the surrounding edge 12, should define a profile or area at least equal to or greater than the profile or area of ​​the existing mask. Thus, exhaled air from the patient is retained inside the shield body 11, including above the lower segment 15. By way of example, as shown at least in FIGS. 4 and 9-10, the edge 12 can have a semi-oval configuration. As perhaps best shown in FIGS. 4 and 9, the edge 12 can also define a substantially flat side profile of the shield body 11. However, the shield body 11 may have other shapes that correspond to the shape of the existing mask. The lower segment 15 can be configured and dimensioned to accommodate the size and / or geometry of the oxygen delivery tube of a BIPAP or CPAP mask, or the size and / or geometry of the nebulizer unit and / or its components.

[0022]

[0103] The exemplary embodiments of FIGS. 6-9 and 11 show a retention assembly 20 comprising a retention component 21 and its upper section 21″ that provides a vertical offset. The length of the upper section 21″ can be configured and dimensioned depending on preference, the type of existing mask, the intended use, the amount of height adjustment desired for the shield body 11, etc. In these exemplary embodiments, both the retention component 21 and the upper section 21″ comprise a substantially cylindrical configuration having approximately the same diameter. Conversely, as in the exemplary embodiment of FIGS. 1-5, the retention assembly 20 may be provided with a retention component 21 without an upper section 21″. It is within the scope of the present invention that the connecting portion 18 of the shield body 11 is attachable to the retention component 21 and / or its upper section 21″. For example, the connecting component 18 can comprise a substantially cylindrical configuration and can be configured and dimensioned to correspond to the interior size of the cylindrical retention component 21 and / or upper section 21″. Further to this example, and perhaps best shown in FIGS. 4 and 9 , the outer diameter of the connection component 18 may be at least partially smaller than the inner diameter of the retaining component 21 and / or upper section 21″ such that the connection component 18 can be inserted into the retaining component 21 and / or upper section 21″. In at least one embodiment, the retaining component 21 and the upper section 21″ can have the same diameter. Furthermore, in such an embodiment, the diameters of both the connection component 18, the retaining component 21 and / or the upper section 21″ can be configured and dimensioned to allow frictional resistance between corresponding surfaces such that the shield body 11 can be connected to the retaining assembly 20 and further remain in place during operation or use of the vacuum shield assembly 10 of the present invention.

[0023]

[0104] As perhaps best shown in the exemplary embodiments of FIGS. 2-5 and 7-11 , the retention component 21 of the retention assembly 20 includes a lower section 21′. The interior of the lower section 21′ of the retention component 21 should be disposed in fluid communication with the interior of the retention component 21, the interior of the connection portion 18 of the shield body 11, the interior of the upper section 21″ of the retention component, and / or the interior of the vacuum tube. Further, the lower section 21′ of the retention component 21 can be configured and dimensioned to be attached to the vacuum tube. By way of example only, the lower section 21′ of the retention component 21 can be provided with an outer diameter that is at least partially smaller than the inner diameter of the vacuum tube. Thus, the vacuum tube can be attached to the exterior of the lower section 21′ of the retention component 21 and disposed in fluid communication with the interior of the lower section 21′ of the retention component 21, the interior of the retention component 21, the interior of the upper section 21″ of the retention component 21, and / or the interior of the connection portion 18. This would allow fluid communication between the vacuum tube and the shield body 11, including the interior or inside, which is perhaps best shown in FIG. 10. Actuation of the vacuum tube thus creates a negative pressure around the inside of the shield body 11. Such negative pressure results in at least partial removal of air from the inside and / or surrounding areas of the shield body 11.

[0024]

[0105] As described above and with reference to at least FIGS. 5 and 11 , the retention assembly 20 can include a retention frame 23. The retention frame 23 can be connected to the retention component 21, for example, via a transition structure 22. The retention frame 23 is intended to attach the retention assembly 20, and thus the shield body 11 and vacuum tube, to existing mask components. For example, such components of an existing mask can include an oxygen delivery tube of a CPAP mask or a BIPAP mask. As a further example, such components of an existing mask can also include a nebulizing unit, or a portion or component thereof. The retention frame 23 should include an inner region that can be selectively adjusted to securely hold the oxygen delivery tube or the nebulizing unit or a component thereof. For example, the retention frame 23 can have a substantially cylindrical configuration and / or two segments that can be connected to each other. A first closure structure 25 and a second closure structure 26 can be provided, which can cooperate to form a closure mechanism or engagement portion that holds the oxygen delivery tube or the nebulizing unit. Further by way of example, the first closure structure 25 and / or the second closure structure 26 may be provided with a closure mechanism or associated components that may enable such a closure mechanism or engagement.

[0025]

[0106] In the exemplary embodiment of FIGS. 1-11 , the first closure structure 25 can be provided with a snap component, and the second closure structure 26 can be provided with a notch 25′. The snap component and the notch 25′ can cooperate to form a mating engagement, allowing a user or medical professional to selectively increase or decrease the interior area of ​​the retaining frame 23. For example, a snap can be selectively positioned in any one of multiple notches 25′ along the length of one of the segments of the retaining frame 23. As used herein, a “snap” mechanism generally refers to a single-snap mechanism or a multiple-snap mechanism, i.e., an adjustable mechanism that can be selectively positioned in various size settings. Thus, a single retaining assembly 20 can be used in connection with various oxygen delivery tabs of different sizes and / or nebulizer units of different sizes. One or more flaps 24 and / or 24′ can be provided to further assist a user or medical professional in adjusting the interior area or opening of the retaining frame 23. Flaps 24 and / or 24' can be disposed on or otherwise formed on segments of retainer frame 23, including the periphery of first closure structure 25 and / or second closure structure 25. Flaps 24 and / or 24' can extend along the height of retainer frame 23 and / or can be sized to correspond to the size of a user's or medical professional's thumb and / or finger. Thus, selective movement of flaps 24 and / or 24' results in corresponding movement of at least one of the segments of retainer frame 23, resulting in movement of corresponding closure structures 25 and / or 26. While retainer assembly 20 may be provided with two flaps 24 and 24', it is also possible to provide retainer assembly 20 with only a single flap 24 or no flaps at all.

[0026]

[0107] As perhaps best shown in FIG. 5 , the retaining frame 23 can be provided with at least one retaining segment 28 configured to at least partially retain the nebulizing unit. For example, as shown in the exemplary embodiment of FIG. 3 , two retaining segments 28 can be used to at least partially retain the mid-section of the nebulizing unit. Additionally, each retaining segment 28 can include a latch 29 disposed around its upper end. The latch 29 can be configured to hold the top of the mid-section of the nebulizing unit in place and at least partially reduce vertical movement. As shown in the exemplary embodiment of FIG. 3 , as well as in other embodiments, the retaining frame 23 can be provided with a substantially cylindrical or semi-cylindrical configuration. Such a configuration can be advantageous for retaining or otherwise attaching the retaining assembly 20 to a substantially cylindrical nebulizer or oxygen delivery tube.

[0027]

[0108] Referring now to at least FIGS. 1-3 and 6-8, a feature of the present invention includes providing a vacuum shield assembly 10 having a shield body 11 and a retention assembly 20, which are collectively positionable in and out of an operative position and a non-operative position. As used herein, the term "non-operative position" refers to a position in which the vacuum shield assembly 10 is not in use and may include a storage position, an inactive position, or a position in which the vacuum shield assembly is not connected to an external component, such as an oxygen delivery tube, a vacuum tube, a nebulizer unit, or the patient's face or head. Conversely, as used herein, the term "operative position" refers to a position in which the vacuum shield assembly 10 is operable or otherwise active. In the operative position, the shield body 11 should be connected to and positioned in fluid communication with the retention assembly 20. As shown in at least FIGS. 1-3 and 6-8, in the operative position, the interior or inner side of the shield body 11 should be oriented toward an existing mask that may already be positioned on the patient's face and / or head. In the operating position, the vacuum tube and / or connected vacuum source should apply a negative pressure, resulting in a corresponding negative pressure around and in the area surrounding the shield body 11. In the operating position, the negative pressure applied around the inside or interior of the shield body 11 and / or above the lower segment 15 should be sufficient to at least partially extract exhaled air from the patient. Also, the lower segment 15, together with the inside or interior of the shield body 11, is intended to at least partially retain exhaled air between the patient's face and / or existing mask and the shield body 11. Thus, the movement of the patient's exhaled air outside the area surrounding the shield body 11 can be at least partially reduced so that the negative pressure of the vacuum tube results in efficient removal of the exhaled air.

[0028]

[0109] 17-19D, further embodiments of the present invention relate to a system 1' configured to remove exhaled breath from a patient. Generally, the system 1' according to the present invention is configured to remove exhaled breath from a patient wearing a medical mask, as defined herein, but can also be used with patients not wearing a medical mask, as various components of the system 1' can be at least partially placed directly on the patient. With particular reference to at least FIGS. 17 and 18, the system 1' generally comprises at least a vacuum shield assembly 10, as defined herein, a retention assembly 20, as defined herein, a vacuum tube 40, and a vacuum unit 80. In embodiments of the present invention in which the shield body 11 can be placed directly on a patient not wearing a medical mask, the retention assembly 20 may not be necessary, as the vacuum tube 40 can be placed directly on the shield body 11. As used herein, the vacuum unit 80 refers to a vacuum device that can be operated by a motor, placed in fluid communication with the vacuum tube 40, i.e., a hose, or other flexible or expandable hollow, elongated component, and capable of applying negative pressure. It is contemplated that the shield body 11 of the shield assembly 10 is also disposed in fluid communication with the interior of the vacuum tube 40. The negative pressure of the vacuum unit 80 should be transmitted through the vacuum tube 40 to the inner surface of the shield body 11, i.e., the side facing the patient. Thus, the shield body 11 essentially functions as a vacuum device that can at least partially remove exhaled air from around the patient's face. As used herein, the space defined by the inner surface of the shield body 11 and the patient's face is defined as the sealing zone 19, including when wearing a medical mask.

[0029]

[0110] 18A , a system 1′ according to the present invention may include a vacuum tube 40 and a retaining assembly 20 configured to retain a component of a medical mask as defined herein, i.e., an oxygen delivery tube or nebulizing unit of a BIPAP or CPAP mask, or a portion or component thereof. Furthermore, the vacuum tube 40 may include a body 41 of a flexible or elastic material that can at least partially bend, twist, move, or otherwise conform to geometric constraints. The vacuum tube 40 may include a proximal end 44 that connects to the vacuum unit 80 about the connecting end 36, and a distal end 42 that connects to the shield body 11 about the connecting end 46.

[0030]

[0111] Referring at least to FIGS. 18A-18B , the filter case assembly 50 can be disposed on or integrally formed with the vacuum tube 40 around the proximal end 44. The filter case assembly 50 can include a top segment 52 and a bottom segment 54 that can be operably connected to one another. In other words, the top segment 52 and the bottom segment 54 can form a mating engagement with one another in a fixed position, i.e., once the filter 70 is installed therebetween. The mating engagement between the top segment 52 and the bottom segment 54 is not considered a permanent mating engagement, as the top segment 52 and the bottom segment 54 are removably connected to one another to allow a filter to be inserted and / or removed from the area where they are engaged. The diameters of the top segment 52 and / or the bottom segment 54 should correspond to one another and be configured and dimensioned to accommodate the diameter and / or size of the filter 70, which can comprise an air filter such as an ultra-low particulate air (ULPA) filter. The filter 70 can also comprise a high-efficiency particulate air (HEPA) filter. Thus, the diameter of the top segment 52 and / or the bottom segment 54 may be larger than the diameter of the vacuum tube 40, although this is not strictly necessary. If the top segment 52 and the bottom segment 54 form an engaging fit, this should limit the installation or otherwise movement of the filter 70 disposed therein. Additionally, the top segment 52 and / or the upper segment 54 may be provided with a conical or semi-conical shape. This may be done to at least partially facilitate airflow through the vacuum tube 40 and into the vacuum unit 80 and / or to at least partially reduce the possibility of a bottleneck effect around the area where the filter 70 is otherwise disposed. As a result, air trapped around the distal end 42 of the vacuum tube passes through the filter 70 before entering the vacuum unit 80, at least partially reducing contaminants and / or other infectious particles.

[0031]

[0112] 17 and 18B , as described above, the system 1′ according to the present invention includes a vacuum unit 80. The vacuum unit 80 should provide a portable solution for generating a negative vacuum pressure at least around a first opening 84 thereof, to which the vacuum tube 40 is connected. The vacuum unit 80 may include a housing 82 having a first opening 84 and a second opening 86. The first opening 84 is generally configured to attach the vacuum tube 40, for example, around its proximal end 44. The second opening 86 is generally configured to vent trapped air to the exterior of the housing 82. That is, air collected from the containment zone 19 that passes through the first opening 84 and enters the interior of the housing 82 should be able to exit the housing 82 through the second opening 86. Alternatively, the housing may be provided with other means for venting air, including slots or vents, including those located on the sides. Additionally, the interior of housing 82, which is generally a chamber, may be provided with other filtration means to further remove contaminants and / or infectious particles from the air captured around containment zone 19. Also, the top cover of the housing may be removable from the remainder of housing 82 to access any components thereof, which may include a battery-operated vacuum component with a motor, additional filtering components, etc. By way of example only, a 110V or similar battery-operated vacuum motor may be provided inside housing 82.

[0032]

[0113] Unique to the system 1′ according to the present invention, the vacuum unit 80, the vacuum tube 40, and the shield body 11 can be collectively positionable in and out of an operative and a non-operative orientation. The operative orientation includes the vacuum unit 80 being activated to apply negative pressure inside the shield body 11, i.e., around the sealing zone 19, to at least partially remove the patient's exhaled air. The non-operative operation includes non-operational periods of the system 1′, including when the vacuum unit 80 is inactive. Additionally, the shield body 11, the vacuum tube 40, and the retention assembly 20 can be collectively positionable in and out of an operative and a non-operational position. Referring to FIG. 18B , the operative position generally includes the shield body 11 being at least partially attached to the patient's head and the vacuum tube 40 being operably connected to the shield body 11. The operative position can also include the vacuum tube 40 and components of the medical mask being positioned on the retention assembly 20. The operational orientation can also include the shield body 11, the vacuum tube 40, and the retention assembly 20 being placed in the operational position, and the vacuum unit 80 being activated to apply a negative pressure inside the vacuum tube 40 and inside the shield body 11 to at least partially remove exhaled air from the patient around the sealing zone 19. In at least one embodiment of the system 1' according to the present invention, the system 1' can remove at least 93% of exhaled air particles having a size of 0.5 microns. To achieve this, the system 1' should be able to provide a negative pressure of at least 240 liters / minute, and in some embodiments, up to about 280 liters / minute, measured around the interior of the shield body 11. This, in turn, achieves at least a partial reduction in rebreathing or reinhalation of up to 6%, while at the same time, given the geometry of the components of the shield body 11, not substantially reducing the amount of inspired oxygen, i.e., oxygen inhaled from the oxygen delivery tube, or nebulized particles. In some embodiments, the amount of nebulized particles provided to the patient is maintained, and in other embodiments, even increased.

[0033]

[0114] Referring now to at least FIGS. 19A-21D, as described above, the various components of the innovative system 1′ can be placed in operating positions as shown in FIGS. 19D, 20D, and 21D. The shield body 11 can be connected to the retention assembly 20 (FIGS. 19A and 20A). The retention assembly 20 can then be connected to the oxygen supply tube (FIG. 20B) or nebulizer (FIG. 19B) of an existing mask. The vacuum tube 40 can then be connected to the retention assembly 20 (FIGS. 19C and 20C). In some embodiments, a medical mask or an existing mask is provided with an adjustable strap. The strap can be inserted between the outer surface of the mask and the retention component (FIG. 21A), and the length of the strap can be adjusted by inserting one of multiple adjustable holes in the strap into the retention component (FIG. 21B). The remaining portion of the strap can be secured to a side structure of the retention component (FIG. 21C). 22, the present invention also relates to a method 200 for removing exhaled breath from a patient. As shown at 210, the method 200 includes the steps of (i) providing a system 1' as defined herein configured to remove exhaled breath from a patient wearing a medical mask. The system 1' can include a vacuum shield assembly 10 including a vacuum unit 80, a vacuum tube 40, an air filter 70 operably disposed inside the vacuum tube 40, a shield body 11 positionable on a patient wearing the medical mask, and a retention assembly 20 configured to hold the vacuum tube and components of the medical mask, wherein the vacuum tube 40 is disposed in fluid communication with the interior of the shield body 11 and the vacuum unit 80, and the vacuum tube 40, shield body 11, and vacuum unit 80 are collectively positionable in and out of an operative orientation and a non-operative orientation. The method 200 includes (ii) placing the shield body 11 on the retention assembly 20, as shown at 220; (iii) placing components of a medical mask on the retention assembly 200, as shown at 230; (iv) placing the vacuum tube 40 in fluid communication with the interior of the shield body 11, as shown at 240; (v) at least partially placing the medical mask on the patient's head, as shown at 250; and (vi) at least partially placing the shield body 11 around the medical mask, as shown at 260. The method 200 may further include at least partially placing the shield body 11 around the medical mask and adjacent to the patient's face to form a sealing zone 19. The method 200 may further include (vii) placing the vacuum tube in fluid communication with the interior of a vacuum unit, as shown at 270; and (viii) activating the vacuum unit to apply negative pressure to the sealing zone and remove exhaled air from the patient, as shown at 280. The method 200 may further include (viii) activating the vacuum unit 80 to apply negative pressure to the inside of the vacuum tube 40 and the inside of the shield body 11 to remove exhaled air from the patient between the inside of the shield body 11 and the patient's face.

[0034]

[0115] II. Intubation Assembly for Protection Against Airborne Diseases

[0116] With initial reference to at least FIGS. 23A-23D, the present invention relates to an intubation assembly, generally designated 1. With reference to at least FIG. 25, the present invention also relates to a shield assembly 20. With reference to FIG. 33, the present invention further relates to a method 100 of using the intubation assembly 1. It is within the scope of the present invention for the intubation assembly 1 and / or the shield 20 to at least partially reduce the risk of airborne disease transmission, including airborne disease transmission, from a patient to a healthcare professional, i.e., a doctor, nurse, assistant, etc., using a negative pressure vacuum. That is, the intubation assembly 1 and / or the shield 20 can function as a physical barrier that can at least partially reduce the airborne transfer of infectious particles, including, but not necessarily limited to, viruses, such as influenza or COVID-19, or bacteria, fungi, etc. The intubation assembly 1 and / or the shield 20 can also at least partially reduce the risk of airborne disease transmission from a healthcare professional to a patient. The intubation assembly 1 generally comprises an intubation device assembly 10 and a shield assembly 20. The intubation device assembly 10 can be operably disposed on the shield assembly 20. Referring at least to FIG. 24 , it is within the scope of the present invention for the intubation assembly 1 and / or shield 20 to be used with an intubation device. As used herein, “intubation device” may include, but is not limited to, laryngoscopes, endoscopes, bronchoscopes, and other fiber optic devices. Also, as used herein, “intubation device” may also refer to, but is not limited to, an endoscope assembly or other related device that may be used in connection with an upper gastrointestinal (GI) endoscopy (EGD) or similar procedure. Furthermore, it is contemplated that the intubation assembly 1 of the present invention may be disposable. However, this is not strictly necessary, as the intubation assembly 1 of the present invention may also be sterilized so that it may be used multiple times.

[0035]

[0117] As shown at least in FIG. 24 and as described above, the intubation assembly 1 of the present invention comprises an intubation device assembly 10. The intubation device assembly 10 comprises an intubation device that can be disposed over a sleeve 12. The sleeve 12 is generally sized to accommodate the size and / or length of the intubation device body 18. It is within the scope of the present invention for the sleeve 12 to comprise a material that can generate sufficient frictional resistance to engage the intubation device once the intubation device is inserted inside the sleeve 12. The sleeve 12 should also comprise a material that is sufficiently flexible to conform to the geometry of the intubation device. It is also contemplated that the material of the sleeve 12 may allow for manual insertion of the intubation device through the sleeve opening 13.

[0036]

[0118] With reference to at least FIGS. 23B and 24 , it is contemplated that the size and geometry of the intubation device assembly 10, including the intubation device and / or sleeve 12, may be configured and dimensioned to allow for handholding by a medical professional after insertion into the shield assembly 20, described below. As shown in at least FIG. 23B , the sleeve 12 may have an elongated and / or curved profile. In the exemplary embodiment of FIG. 24 , the sleeve 12 may have a substantially square opening with rounded corners. Alternatively, as shown in at least FIG. 24 , the sleeve 12 may have a substantially circular opening 13 at one of its ends. Referring again to FIG. 23B , it is contemplated that the opening 13 in the sleeve 12 is sufficiently large to accommodate insertion of the intubation device. Furthermore, in embodiments including a substantially rectangular opening, it is contemplated that the size and configuration of the shield opening 22 may be configured and dimensioned accordingly to allow insertion of the sleeve 12 into the shield body 24. Similarly, in embodiments comprising a substantially cylindrical configuration, the size of opening 13 in sleeve 12 may comprise a diameter at least greater than the diameter of shield opening 22, as also described in more detail below. Additionally, sleeve 12 may also have a tapered shape that allows a medical professional to insert sleeve 12 into a patient's mouth, larynx, esophagus, and / or trachea. As also seen in FIG. 24 , the laryngoscope may also comprise an audiovisual component 19. For example, audiovisual component 19 may comprise a camera.

[0037]

[0119] 25, and as referenced above, the present invention relates to an intubation assembly 1 that includes a shield assembly 20, as well as other embodiments that include only a shield assembly 20. The shield assembly 20 includes a body 24 that may include a plurality of side segments 29. The shield body 24 can include a top surface 36 and a bottom surface 37, as well as a proximal end 24' and a distal end 24". The shield body can include a variety of shapes and / or configurations, including, but not limited to, a substantially arcuate shape as shown throughout the figures. However, this is not necessary, as other shapes and / or configurations are possible. The shield body 24 can primarily comprise a substantially transparent or translucent material. For example, the body 24, including the side segments 29, can primarily comprise a clear plastic. The material of the body 24 can include a rigid clear plastic. The material of the side segments 29 can potentially allow for further positioning adjustment of the shield body 29 and / or can include a flexible material that can at least partially reduce the risk of injury to the patient, similar to the flexible material of the top portion 25, for example. The shield assembly 20 includes a second segment 28 disposed about approximately the middle of the body 24. The shield assembly 20 may include a first transparent component 21. The first transparent component 21 may comprise a substantially transparent or translucent material. Furthermore, the first transparent component 21 may also include a shield opening 22 for inserting the intubation device assembly 10. By way of example, the first transparent component 21 may comprise a transparent silicone sheet having an opening disposed thereon. The shield assembly 20 may also include a second transparent component 23. The second transparent component may include slots 28 to allow fluid communication between an area above the top surface 36 of the shield body 24 and an area below the bottom surface of the shield body 37. It is within the scope of the present invention for the slots 28 to remain substantially closed unless selectively opened by a medical professional, for example, to insert an endotracheal tube, as also described in more detail below. By way of example, the second transparent component 23 may comprise a transparent silicone sheet having longitudinally disposed slots 28.

[0038]

[0120] Also, with reference to at least the exemplary embodiment shown in FIG. 25 , shield assembly 20 of intubation assembly 1 can include upper portion 25. Upper portion 25 can be disposed at distal end 24″ of shield body 24 and can include an elongated configuration. Upper portion 25 can also have a substantially rounded or curved shape. As shown in at least the exemplary embodiment of FIGS. 23A-23B and 25 , upper portion 25 can be disposed at a downward angle relative to shield body 24. Upper portion 25 can potentially include a flexible material to allow adjustment by a user and / or medical professional when positioning shield body 24 on or around a patient and / or to at least partially reduce the risk of injury to the patient, e.g., the patient's neck or chest region. Accordingly, upper portion 25 and bottom surface 37 of shield body 24 can be configured as shown in at least FIG. 23D 25. The upper portion 25 can substantially define a seal 34 shown in FIG. 25. The upper portion 25 can also include a substantially soft or malleable material. For example, the upper portion can include a soft silicone material. Additionally, the upper portion can include at least one vacuum opening 26. The vacuum opening 26 can be disposed in fluid communication with a vacuum connection portion 26′, which itself can be disposed in fluid communication with a vacuum tube. Thus, negative pressure can be transferred from a vacuum tube and / or system to apply to the sealed area 34. As shown in the exemplary embodiment of FIG. 25, two vacuum openings 26 can be provided. Additionally, a cap can be provided to cover one or both of the vacuum openings 26 and / or the vacuum connection portion 26″. As an example, the vacuum opening 26 can include a hose port. The vacuum opening 26 can be operably disposed with a vacuum system to provide negative pressure. As used herein, “vacuum system” can refer to one or more components associated with vacuum equipment, including vacuum tubes or conduits capable of applying negative pressure, and / or other related components, including, but not limited to, vacuum machinery and / or filtration devices.23A-23D and 25, one or more vacuum tubes may be operatively disposed in vacuum opening 26 to enable negative pressure on the side of shield body 24 positioned against the patient's face. Thus, given the operational configuration enabled by the geometry of shield body 24 and vacuum opening 26, the resulting negative pressure should at least partially increase the removal of infectious particles in exhaled breath.

[0039]

[0121] As also shown in at least FIG. 23D , the shield assembly 20 can include a curved portion 27. The curved portion 27 can be substantially defined by the geometric shape of the ends of the side segments 29, which can have, for example, an elliptical configuration. The side segments 29 can be located at the proximal end 24′ of the shield body 24 and can be spaced apart from one another. As shown in at least FIG. 23D , the spacing between the side segments 29 can at least partially define an aperture 35. Thus, the curved portion 27 of the body 24 advantageously accommodates the arm of a medical professional when holding the intubation device assembly 10. Furthermore, it is within the scope of the present invention for the curved portion 27, the side segments 29, and / or the shield body 24 to be configured and dimensioned to define an aperture 35 of a geometry and / or sufficient size that can allow a user or medical professional to place their hand through the aperture 35 and into the sealing area 34. Thus, a user or medical professional can grasp the sleeve 12 inserted into the shield body 24.

[0040]

[0122] 23B and 26, as described above, it is within the scope of the present invention for the intubation device assembly 10 to be inserted into the sleeve opening 13 of the shield body 24. Thus, a medical professional can grasp and / or position the intubation device assembly 10 over the intended area of ​​the patient's body, e.g., the mouth, larynx, esophagus, and / or trachea. Because the diameter of the substantially circular configuration 13 of the sleeve 12 must be at least larger than the diameter of the shield opening 22, the sleeve 12 should be held around its end on the first transparent component 22. However, the sleeve 12 should protrude onto the opposite side of the shield body 24, i.e., the side facing the patient. As perhaps best shown in FIG. 26, the sleeve 12 should remain movable relative to the shield body 24 after insertion. However, the sleeve 12 should substantially pass through the shield opening 22.

[0041]

[0123] As perhaps best shown in the exemplary embodiment of FIG. 25 , the shield body 24 can include a sleeve retainer 32 disposed on the bottom surface 37. The sleeve retainer 32 is intended to serve as a guide and / or support for the sleeve 12 when it is inserted into the shield body 24. Thus, the sleeve retainer 32 can be a channel or conduit that can extend below the shield opening 22 in a direction substantially perpendicular to the bottom surface 37. The sleeve retainer 32 should include an opening that corresponds to the shape of the shield opening 22 and / or the sleeve 12, e.g., substantially square or substantially circular. The sleeve retainer 32 should allow for movement and / or adjustment of the inserted sleeve 12. For example, the sleeve retainer 32 can include four adjacently disposed walls to form a substantially square configuration extending away from the bottom surface 37. The sleeve retainer 32 can include a recessed wall. That is, at least one of the adjacently disposed walls of the sleeve retainer 32 can have a shorter length such that the other three walls at least partially permit movement and / or adjustment of the sleeve 12 in at least one direction. Additionally, an expandable component 33 can be provided along one or more of the walls to further permit further movement and / or adjustment of the sleeve 12 in at least one direction, and in some embodiments, several directions. The expandable component 33 can comprise corrugations or grooves in the wall of the sleeve retainer 32 and can at least partially permit such further movement and / or adjustment of the sleeve 12 once the sleeve 12 is inserted.

[0042]

[0124] 23A-23D and 25, the shield assembly 20 may include a reinforcing component 30 and / or an overlapping portion 31. The reinforcing component 30 and / or the overlapping portion 31 may be provided to at least partially increase the stability of the shield body 24 and / or at least partially reduce bending of the shield body 24. As can be seen in at least FIG. 23D, the reinforcing component 30 may be disposed on or otherwise formed on the upper surface 36 of the shield body 24 around the proximal end 24'. The reinforcing component 30 may extend substantially along the width of the upper surface 36 of the shield body. The reinforcing component 30 may have an elongated configuration and / or may follow or otherwise correspond to the profile of the curved portion 27. The reinforcing component 30 may also be offset relative to the curved portion 27 and / or the side segment 29. Conversely, as can be seen in at least FIGS. 23A-23C and 25, an overlap portion can be disposed on or otherwise formed on the upper surface 36 of the shield body 24 around its distal end 24″. The overlap portion 31 can be formed by an overlay or other intersection between the shield body 24 and the upper portion 25.

[0043]

[0125] 26-30, features of the present invention include positioning the intubation assembly 1 and / or shield assembly 20 of the present invention in and out of operative and non-operative positions. As used herein, the "non-operative position" of the intubation assembly 1 and / or shield assembly 20 of the present invention refers to the non-operation and / or storage of the various components of the intubation assembly 1 and / or shield assembly. The "non-operative position" may also refer to a position of the intubation assembly 1 and / or shield assembly 20 without the sleeve 12 being installed within the shield body 24 or without the shield assembly 20 being positioned adjacent to the patient's face and / or head. Furthermore, the "non-operative position" may also refer to the non-operation of a vacuum system connected to the shield assembly 20 and / or shield body 24. Referring to FIG. 28, as used herein, the "operative position" of the intubation assembly 1 and / or shield assembly generally includes the intubation device assembly 10, sleeve 12, and / or intubation device being operatively positioned on the shield 24, i.e., inserted through the shield opening 22. The term "operating position" may also refer to the intubation device assembly 10, sleeve 12, and / or intubation device being positioned in the patient's mouth, larynx, esophagus, and / or trachea, which may be collectively referred to as the patient's mouth for simplicity. The term "operating position" may also refer to the shield body 24 being positioned adjacent to the patient and / or the bottom surface 37 facing the patient. Furthermore, the term "operating position" may include the vacuum system being connected to the vacuum opening 26 and / or the vacuum connection portion 26' and positioned in an operating configuration, i.e., applying negative pressure, such that negative pressure is transmitted to the sealed area 34 and / or the area surrounding the patient. Thus, exhaled air may be at least partially extracted from the area surrounding the patient while the user or practitioner is performing an intubation procedure.

[0044]

[0126] As shown in FIG. 27 , the intubation device assembly 10 and / or the shield assembly 20 with the sleeve 12 inserted therein can be positioned at a slight angle relative to the patient's body. This at least partially facilitates initial insertion of the sleeve 12 into the patient's mouth. Here, the upper portion 25 of the shield assembly 20 may come into contact with the patient's neck. Therefore, it is advantageous to provide the upper portion 25 with a substantially soft material, such as soft silicone, to at least partially reduce the risk of physical injury, including around the patient's neck. Once the sleeve 12 is initially inserted into the patient's mouth, the shield assembly 20 can be manually moved from the position shown in FIG. 27 to the position shown in FIG. 28 . During this process, the sleeve 12 can be inserted deeper into the mouth and into the patient's larynx, esophagus, and / or trachea. As shown in FIG. 29 , when the shield assembly 20 and / or the intubation device assembly 10 are positioned in the operative position, i.e., the position shown in FIG. 28 , an endotracheal tube can be passed through the slot 28 from the outside of the shield body 24 to the opposite side facing the patient. After insertion through at least one of the slots 28, the endotracheal tube can be placed in the patient's mouth. The endotracheal tube can then be selectively positioned in the intended area of ​​the patient, e.g., the intended location of the larynx and / or trachea. At this stage, the audiovisual component 19 can assist the medical professional in positioning the endotracheal tube over the intended area of ​​the patient. As shown in FIG. 30, after the endotracheal tube has been inserted and / or positioned in the intended area of ​​the patient, the shield assembly 20 and the intubation device assembly 10 can be removed.

[0045]

[0127] 31-32, an additional feature of the present invention includes providing the shield assembly 20 and / or the intubation assembly 1 with an offset structure 38. In some applications, it may be important for the shield body 24 to be connected to the patient's head to at least partially limit movement of the shield 24 relative to the patient's body. For example, during upper GI endoscopy (EGD) and / or bronchoscopy, a retention component, i.e., an adjustable strap, tie, band, etc., may be provided to position the shield body 24 around the patient's head. The retention component should at least partially reduce movement of the shield body 24 relative to the patient's body. The retention component may be connected to the shield body around a secondary slot or opening configured and dimensioned to accommodate the size of the retention component. In such applications, e.g., upper GI endoscopy (EGD), bronchoscopy, and / or related procedures, the shield body 20 may be provided with an offset structure 38, which is primarily intended to provide spacing between the shield body 24 and the patient's body and to guide the head, forehead, face, neck, upper chest, and / or shoulders, etc. It is within the scope of the present invention that such spacing of the body from the offset structure 38 may be beneficial to at least partially protect areas of the patient that may otherwise come into direct contact with the shield body 24, such as the head, forehead, face, neck, upper chest, and / or shoulders. Accordingly, the offset structure 38 may be provided about the bottom surface 37 of the shield body 24.

[0046]

[0128] As seen in FIGS. 31-32 , offset structure 38 can be provided around bottom surface 37 of shield body 24, including around top portion 25 and / or side segments 29. By way of example only, offset structure 38 can include a foam pillow-like liner or other related material, such as a foam pad, to function to elevate or otherwise raise the position of shield body 24 relative to the patient's body. Thus, once shield body 24 is positioned on the patient's head, an intubation device, such as a bronchoscope and / or endoscope, can be inserted through shield opening 22. In such embodiments, it is further contemplated that vacuum opening 26 and / or vacuum connection portion 26 also operate as described herein to at least partially remove exhaled air from the patient using an operably connected vacuum system. In such embodiments, a retainer 33′ can be provided in addition to or instead of offset structure 38. Instead of facing inward, i.e., away from bottom surface 37 and / or toward the patient, retainer 33′ can be oriented outward, i.e., away from top surface 36. Providing retainer 33' can further assist the user or practitioner in inserting the intubation device, for example, an EGD device, bronchoscope, and / or other related device can be inserted through retainer 33' disposed around shield opening 22. Similar to sleeve retainer 33, retainer 33' is intended to act as a guide for the intubation device.

[0047]

[0129] Referring now to FIG. 33 , the present invention further relates to a method 100 of using the intubation assembly 1 of the present invention. As shown at 110, the method 100 initially includes the step of providing an intubation assembly 1 including an intubation device assembly 10 and a shield assembly 20 as described herein. As shown at 120, the method 100 further includes the step of placing an intubation device within the sleeve 12 of the intubation device assembly 10 of the intubation assembly 1 of the present invention. As shown at 130, the method 100 further includes the step of inserting the sleeve 12 through the opening 22 of the shield body 24. As shown at 140, the method 100 further includes the step of inserting a user's hand into the sealing region 34 and grasping the sleeve 12. As shown at 150, the method 100 further includes the step of positioning the sleeve 12 within the patient's mouth. It should be understood that when the sleeve 12 is positioned within the patient's mouth, the shield body 24 will at least partially surround the patient's face and / or head, and the bottom surface 37 of the shield body 24 should face the patient. As shown at 160, the method 100 further includes placing the shield 24 assembly and the intubation device assembly into an operative position.

[0048]

[0130] Referring to FIGS. 34-40 , a further embodiment of the present invention relates to a system 1′ configured to remove exhaled air from a patient. Generally, the system 1′ according to the present invention is configured to remove exhaled air from a patient by placing a shield body 24 around the patient's upper body region, i.e., the neck and / or face region. Referring at least to FIGS. 34 and 35 , the system 1′ generally comprises a shield assembly 20 as defined herein, including a shield body 24 and / or 62, a vacuum tube 40, and a vacuum unit 80. As used herein, vacuum unit 80 refers to a vacuum device that can be motorized, can be placed in fluid communication with the vacuum tube 40, i.e., a hose, or other flexible or expandable hollow elongated component, and can apply negative pressure. It is contemplated that the shield body 24 of the shield assembly 20 can also be placed in fluid communication with the interior of the vacuum tube 40. The negative pressure of the vacuum unit 80 should be transmitted through the vacuum tube 40 to the inner surface of the shield body 24, i.e., the area defined below the bottom surface 37, the side of the shield body 24 facing the patient, and / or the sealed area 34. Thus, the shield body 24 essentially functions as a vacuum device that can at least partially remove exhaled air around the patient's face. As used herein, the space defined by the inner surface of the shield body 24 and the patient's face is defined as the sealed area 34, including when wearing a medical mask.

[0049]

[0131] 35 , the vacuum tube 40 can include a body 41 of a flexible or resilient material that can at least partially bend, twist, move, or otherwise conform to geometric constraints. The vacuum tube 40 can include a proximal end 44 that connects to the vacuum unit 80 about the connecting end 36, and a distal end 42 that connects to the shield body 24 about the connecting end 46. As also shown in at least FIG. 35 , the shield body 24 can also include a plurality of offset structures 38 that can assist in positioning the shield body 24 on the patient's head.

[0050]

[0132] Referring at least to FIG. 34 , the filter case assembly 50 can be disposed on or integrally formed with the vacuum tube 40 around the proximal end 44. The filter case assembly 50 can include a top segment 52 and a bottom segment 54 that can be operably connected to one another. In other words, the top segment 52 and the bottom segment 54 can form a mating engagement with one another in a fixed position, i.e., once the filter 70 is installed therebetween. The mating engagement between the top segment 52 and the bottom segment 54 is not considered a permanent mating engagement, as the top segment 52 and the bottom segment 54 are removably connected to one another to allow a filter to be inserted and / or removed from the area where they are engaged. The diameters of the top segment 52 and / or the bottom segment 54 should correspond to one another and be configured and dimensioned to accommodate the diameter and / or size of the filter 70, which can comprise an air filter such as an ultra-low particulate air (ULPA) filter. The filter 70 can also comprise a high-efficiency particulate air (HEPA) filter. Thus, the diameter of the top segment 52 and / or the bottom segment 54 may be larger than the diameter of the vacuum tube 40, although this is not strictly necessary. If the top segment 52 and the bottom segment 54 form an engaging fit, this should limit the installation or otherwise movement of the filter 70 disposed therein. Additionally, the top segment 52 and / or the upper segment 54 may be provided with a conical or semi-conical shape. This may be done to at least partially facilitate airflow through the vacuum tube 40 and into the vacuum unit 80 and / or to at least partially reduce the possibility of a bottleneck effect around the area where the filter 70 is otherwise disposed. As a result, air trapped around the distal end 42 of the vacuum tube passes through the filter 70 before entering the vacuum unit 80, at least partially reducing contaminants and / or other infectious particles.

[0051]

[0133] Referring at least to FIG. 34 , as described above, the system 1′ according to the present invention includes a vacuum unit 80. The vacuum unit 80 should provide a portable solution for generating a negative vacuum pressure at least around its first opening 84, to which the vacuum tube 40 is connected. The vacuum unit 80 can include a housing 82 having a first opening 84 and a second opening 86. The first opening 84 is generally configured to attach the vacuum tube 40, for example, around its proximal end 44. The second opening 86 is generally configured to vent trapped air to the exterior of the housing 82. That is, air collected from the enclosed area 34 that passes through the first opening 84 and enters the interior of the housing 82 should be able to exit the housing 82 through the second opening 86. Alternatively, the housing can be provided with other means for venting air, including slots or vents, including those located on the sides. Additionally, the interior of the housing 82, which is generally a chamber, can be provided with other filtering means for further removing contaminants and / or infectious particles from the trapped air around the enclosed area 34. Also, the top cover of the housing may be removable from the remainder of the housing 82 to access any components thereof, which may include a battery operated vacuum component with a motor, additional filtering components, etc. By way of example only, a 110V or similar battery operated vacuum motor may be provided inside the housing 82. In at least one embodiment, a 110V battery operated vacuum motor may be provided inside the housing 82.

[0052]

[0134] Unique to the system 1′ of the present invention, the vacuum unit 80, vacuum tube 40, and shield body 24 can be collectively positionable in and out of an operative and non-operative orientation. The operative orientation involves the vacuum unit 80 being activated to apply negative pressure inside the shield body 24, i.e., around the sealed region 34, to at least partially remove the patient's exhaled air. The non-operative orientation includes non-operative periods of the system 1′, including when the vacuum unit 80 is inactive. It is contemplated that the shield body 24 can be positioned in and out of an operative position, as shown at least in FIGS. 38B and 14E . The operative position generally includes an intubation device being positioned over the shield opening 22 and in the patient's mouth. The operative position can also include the interior, i.e., bottom surface 37, of the shield body 24 facing the patient. Alternatively, referring again to at least FIG. 40 , the operative position can include an intubation device being positioned within the opening 68 of the shield body 62 and through the neck opening into the patient's trachea, with the interior or inner surface 63′ of the shield body 63 facing the patient's neck. In the operating orientation, the shield body is placed in the operating position and the vacuum unit 80 is activated to apply a negative pressure to the inside of the shield body and otherwise sealed region 34 to at least partially remove exhaled air from the patient.

[0053]

[0135] Referring to at least FIGS. 38-40 , in an alternative embodiment, a system 1′ according to the present invention can be implemented with a tracheal shield assembly 60 including a shield body 62 positioned around a patient's neck region to access the trachea. In such an embodiment of the system 1′ according to the present invention, the tracheal shield assembly 60 can be provided for performing an intubation or related procedure, such as a tracheotomy or bronchoscopy, around a patient's tracheal region. The tracheal shield assembly 60 primarily includes straps or other components of the shield body 62 used to hold the shield body 62 around the patient's neck. As seen in at least FIGS. 39-40 , the shield body 62 can include upper and lower ends 67 and 61 designed to extend above and below the neck opening (shown in FIG. 38 ). The shield body 62 can include an opening 68 with an optional cap or other sealing mechanism. The location of the opening 68 should correspond approximately to the location of the neck opening. Thus, the opening 68 can allow for direct insertion of intubation components into the patient's trachea without requiring insertion through the patient's mouth. At least one vacuum opening 66' may be provided on either side of the opening 68 to allow other components to be attached to the shield body 62 around its outer surface 13'. The inner surface 13' of the shield body 62 should be positioned facing the patient's neck area. Such other components that may be attached to the shield body 62 include a vacuum tube 40 that may be connected around the connecting segment 66'. As shown in FIG. 40, an oxygen supply tube may also be connected to the connecting segment 16'. Therefore, the components connected through the opening 66, i.e., the oxygen supply tube and / or the vacuum tube, should be positioned to be in fluid communication with the interior or inner surface 13' of the shield body 62. Additionally, a safety inhalation valve and / or a safety flutter valve 64 may be positioned on the shield body 62 as an emergency function in case of patient asphyxiation or oxygen supply failure or other malfunction.

[0054]

[0136] 36A-36D, as described above, various components of the innovative system 1' can be placed in an operational position as shown in at least FIGS. 36E and 38B. The shield body 24 and / or 62 can be connected to a vacuum tube and / or an oxygen supply tube (e.g., FIG. 36A). The sleeve 12 or an intubation device can then be inserted through the opening 26 (e.g., FIG. 36B). The shield body 24 and / or 62 can then be positioned on the patient (e.g., FIGS. 36C-36D). An endotracheal tube can then be inserted through the slot 28 and / or opening 68 into the patient's mouth and / or trachea (e.g., FIG. 36E). The shield body 24 can then be removed once the patient is intubated (e.g., FIG. 36F). As shown in FIGS. 37A-38B and FIG. 17, in some embodiments, the shield body 25 and / or 62 can be provided with a strap. 37A-37E, the straps can be inserted into slots in the shield body 24, which can be configured and dimensioned to receive the straps. The straps can then be adjusted to securely hold the shield body 24 on the patient's head. The ends of the straps can be connected to other portions of the same strap using, for example, a hook and loop connection or other connection mechanism. 41 , the present invention also relates to a method 200 for removing exhaled breath from a patient. As shown at 210, method 200 includes the steps of (i) providing a system 1′ as defined herein configured to remove exhaled breath from a patient wearing a medical mask. System 1′ includes a vacuum unit 80, a vacuum tube 40, an air filter 70 operably disposed inside vacuum tube 40, a shield body 24 configured and dimensioned for insertion of an intubation device, and a vacuum shield assembly 20 including at least one vacuum opening 26 disposed in shield body 24, wherein vacuum tube 40 is disposed in fluid communication with the interior of shield body 24 and vacuum unit 80, and wherein vacuum tube 40, shield body 24, and vacuum unit 80 are collectively positionable in and out of an operative and non-operative orientation. Method 200 may further include the steps of (ii) attaching a vacuum tube to the at least one vacuum opening, as shown at 220, (iii) applying negative pressure to the inside of the shield body using a vacuum unit, as shown at 230, (iv) inserting an intubation device into the patient's mouth, as shown at 240, (v) inserting an endotracheal tube through the shield body and positioning the endotracheal tube over the patient's trachea, as shown at 250, and (vi) removing the shield body from the patient, as shown at 260. Method 200 may further include inserting an intubation device into the patient's mouth while shield body 24 is positioned adjacent the patient's face, and using vacuum unit 80 to apply negative pressure to sealing region 34 or otherwise between shield body 24 and the patient's face.

[0055]

[0137] Because many modifications, variations, and changes in detail may be made to the described preferred embodiment of the invention, it is intended that all matter set forth in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. The scope of the invention should therefore be determined by the appended claims and their legal equivalents. The present invention also includes the embodiments described in the following clauses. Clause 1 1. A vacuum shield assembly positionable over a patient wearing a medical mask and configured to remove exhaled air from the patient, the vacuum shield assembly comprising: a shield body having a recessed shape; a lower segment disposed along a lower periphery of the shield body and including an opening; a holding assembly configured to hold a vacuum tube and an oxygen supply tube or a nebulizer unit of the medical mask; the lower segment is configured to be attached to the vacuum tube and to apply a negative pressure to an interior of the shield body; A vacuum shield assembly, wherein the shield body and the retention assembly are collectively positionable into and out of operative and non-operative positions. Clause 2 10. The vacuum shield assembly of claim 1, wherein the concave shape of the shield body is dimensioned and configured to at least partially surround the medical mask. Clause 3 3. The vacuum shield assembly of claim 2, wherein in the operating position, the shield body is positioned adjacent to and facing the medical mask. Clause 4 4. The vacuum shield assembly of claim 3, wherein the curved shape is configured to define a space around the oxygen supply tube or the nebulizer unit of the medical mask. Clause 5 The vacuum shield assembly of clause 1, wherein in the operating position, the vacuum tube further applies negative pressure to the inside of the shield body to at least partially remove exhaled air from the patient between the shield body and the medical mask. Clause 6 10. The vacuum shield assembly of claim 1, wherein the lower segment has a substantially curved shape. Clause 7 10. The vacuum shield assembly of claim 1, wherein the shield body further comprises an edge that defines a substantially flat side profile of the shield body. Article 8 8. The vacuum shield assembly of clause 7, wherein the edge has a semi-oval shape. Article 9 10. The vacuum shield assembly of claim 1, wherein the shield body further comprises a connecting portion arranged in fluid communication with the opening of the shield body. Article 10 the retention assembly: a retaining component configured and dimensioned to retain the connecting portion of the shield body; a lower section of the retention component configured and dimensioned to be attached to a vacuum tube; a holding frame connected to the holding component and configured to hold the oxygen supply tube or the nebulizer unit of the medical mask; 2. The vacuum shield assembly of claim 1, comprising: Article 11 11. The vacuum shield assembly of claim 10, wherein the retaining frame has a semi-cylindrical shape. Article 12 A vacuum shield assembly as described in clause 10, wherein the holding assembly comprises a first closure mechanism and a second closure mechanism cooperatively configured to adjust an inner area of ​​the holding component, each of the first closure mechanism and the second closure mechanism being positioned on the holding frame. Article 13 13. A vacuum shield assembly as described in clause 12, wherein the retaining frame has a semi-cylindrical shape, the first closure mechanism comprises a plurality of notches, and the second closure mechanism comprises a snap mechanism configured and dimensioned to operate together with the plurality of notches to adjust the sleeve size of the retaining frame. Article 14 13. The vacuum shield assembly of claim 12, wherein the first closure mechanism comprises a first flap and the second closure mechanism comprises a second flap, the first flap and the second flap being cooperatively configured to adjust the inner region of the retaining frame. Article 15 11. A vacuum shield assembly as described in clause 10, comprising at least one holding segment disposed on the holding frame, the at least one holding segment configured to at least partially hold the nebulizer unit. Article 16 16. A vacuum shield assembly as described in clause 15, wherein the at least one retaining segment includes a latch disposed at its upper end, the latch configured to at least partially reduce vertical movement of the nebulizer unit. Article 17 11. The vacuum shield assembly of claim 10, wherein the retaining component comprises an upper section configured and dimensioned to retain the connecting portion of the shield body. Article 18 11. The vacuum shield assembly of claim 10, wherein the holding frame comprises an expandable component configured to expand in accordance with movement of the oxygen supply tube or the nebulizer unit of the medical mask. Article 19 1. A vacuum shield assembly positionable over a patient wearing a medical mask and configured to remove exhaled air from the patient, the vacuum shield assembly comprising: a shield body having a concave shape sized and configured to at least partially surround the medical mask; a lower segment disposed along a lower periphery of the shield body and including an opening; a connecting portion disposed in fluid communication with the opening; a holding assembly configured to hold the vacuum tube and an oxygen supply tube or nebulizer unit of the medical mask; wherein the shield body and the retention assembly are collectively positionable into and out of operative and inoperative positions; In the operating position, the shield body is disposed adjacent to and faces the medical mask; The vacuum shield assembly further comprises, in the operating position, the vacuum tube applying a negative pressure to an interior of the shield body to at least partially remove exhaled air from the patient between the shield body and the medical mask. Article 20 1. A vacuum shield assembly positionable over a patient wearing a medical mask and configured to remove exhaled air from the patient, the vacuum shield assembly comprising: a shield body having a recessed shape; a lower segment disposed around a lower periphery of the shield body and including an opening; a holding assembly configured to hold a vacuum tube and an oxygen supply tube or a nebulizer unit of the medical mask; wherein the retention assembly comprises: a retaining component configured and dimensioned to retain a connecting portion of the shield body; a lower section of the retention component configured and dimensioned to be attached to a vacuum tube; a holding frame having a semi-cylindrical shape, connected to the holding component, and configured to hold an oxygen supply tube or a nebulizer unit of the medical mask; Equipped with the lower segment is configured to be attached to the vacuum tube and to apply a negative pressure to an interior of the shield body; 1. A vacuum shield assembly, wherein the shield body and the retention assembly are collectively positionable in and out of an operative position and a non-operative position, and in the operative position, the vacuum tube applies negative pressure to an interior of the shield body to at least partially remove exhaled air from the patient between the shield body and the medical mask. Article 21 1. A vacuum shield assembly positionable over a patient wearing a medical mask and configured to remove exhaled air from the patient, the vacuum shield assembly comprising: a shield body comprising a lower segment disposed below a lower periphery of the shield body and comprising a first opening; an upper segment disposed above the lower segment and having a top surface, a bottom surface, and a second opening; The shield body, a holding assembly configured to hold an evacuated tube and a component of the medical mask; Equipped with the lower segment is configured to be attached to the vacuum tube and to apply a negative pressure to an interior of the shield body; A vacuum shield assembly, wherein the shield body and the retention assembly are collectively positionable into and out of operative and non-operative positions. Article 22 22. The vacuum shield assembly of claim 21, wherein the upper segment has a concave shape. Article 23 23. The vacuum shield assembly of claim 22, wherein the concave shape of the shield body is dimensioned and configured to at least partially surround the medical mask. Article 24 22. The vacuum shield assembly of claim 21, wherein the second opening is located substantially in the mid-section of the upper segment and above the first opening. Article 25 22. The vacuum shield assembly of claim 21, further comprising a vacuum attachment disposed substantially around the second opening. Article 26 22. The vacuum shield assembly of claim 21, wherein the second opening is configured and dimensioned to receive a connecting segment of the medical mask. Article 27 27. The vacuum shield assembly of claim 26, wherein the second opening is configured and dimensioned to receive a connection segment of a bag-valve-mask (BVM) ventilator mask or a demand-valve ventilator (DVR) mask. Article 28 27. The vacuum shield assembly of clause 26, further comprising a vacuum attachment disposed substantially around the second opening. Article 29 29. The vacuum shield assembly of claim 28, wherein the vacuum attachment is configured to substantially define a seal between the second opening and the connection segment of the bag-valve-mask (BVM) ventilator mask or the demand-valve ventilator (DVR) mask. Article 30 29. The vacuum shield assembly of claim 28, wherein the vacuum attachment is configured to substantially form a seal between the top surface and the bottom surface around the second opening when the connection segment of the bag-valve-mask (BVM) ventilator mask or the demand-valve ventilator (DVR) mask is inserted into the second opening. Article 31 22. The vacuum shield assembly of claim 21, wherein in the operating position, the shield body is positioned adjacent to and facing the medical mask, and the vacuum tube applies negative pressure to the inside of the shield body to at least partially remove exhaled air from the patient between the shield body and the medical mask. Article 32 32. The vacuum shield assembly of claim 31, wherein the curved shape is configured to define a space around the oxygen delivery tube or the nebulizer unit of the medical mask. Article 33 22. The vacuum shield assembly of claim 21, wherein the shield body further comprises a connecting portion disposed in fluid communication with the opening of the shield body. Article 34 1. A vacuum shield assembly positionable on a patient wearing a bag-valve-mask ventilator (BVM) mask or a demand-valve ventilator (DVR) mask and configured to remove exhaled air from the patient, comprising: a shield body having a recessed shape; a lower segment disposed below a lower periphery of the shield body, the lower segment having a substantially curved shape and a first opening; an upper segment disposed above the lower segment and having a second opening disposed in a middle section thereof; a vacuum attachment disposed about the second opening, the second opening configured and dimensioned to receive a connection segment of a bag-valve-mask respirator (BVM) mask or a demand-valve respirator (DVR) mask; a vacuum attachment configured to substantially form a seal between the second opening and the connection segment of the bag-valve-mask respirator (BVM) mask or demand-valve respirator (DVR) mask; and a holding assembly configured to hold at least a vacuum tube and at least components of a bag-valve-mask ventilator (BVM) unit or a demand-valve ventilator (DVR) unit; Equipped with the lower segment is configured to be attached to the vacuum tube and to apply a negative pressure to an interior of the shield body; A vacuum shield assembly, wherein the shield body and the retention assembly are collectively positionable into and out of operative and non-operative positions. Article 35 35. The vacuum shield assembly of claim 34, wherein the vacuum attachment comprises a silicone material. Article 36 35. The vacuum shield assembly of claim 34, wherein the vacuum attachment has a substantially circular shape configured and dimensioned to correspond to the geometric shape and size of the second opening. Article 37 35. The vacuum shield assembly of claim 34, wherein the vacuum attachment comprises a grommet arrangement. Article 38 35. The vacuum shield assembly of claim 34, wherein the grommet arrangement comprises a plurality of adjacently disposed segments cooperatively positionable in and out of open and closed positions. Article 39 39. The vacuum shield assembly of claim 38, wherein each of the plurality of segments has a substantially triangular shape. Article 40 1. A vacuum shield assembly positionable on a patient wearing a bag-valve-mask ventilator (BVM) mask or a demand-valve ventilator (DVR) mask and configured to remove exhaled air from the patient, comprising: The shield body, a lower segment disposed below a lower periphery of the shield body and including a first opening; an upper segment disposed above the lower segment and having a second opening disposed in a middle section thereof; a vacuum attachment disposed about the second opening, the second opening configured and dimensioned to receive a connection segment of a bag-valve-mask respirator (BVM) mask or a demand-valve respirator (DVR) mask; a vacuum attachment having a grommet configuration and a substantially circular shape, the vacuum attachment configured to substantially form a seal between the second opening and the connection segment of the bag-valve-mask respirator (BVM) mask or demand-valve respirator (DVR) mask; a holding assembly configured to hold at least a vacuum tube and at least components of a bag-valve-mask ventilator (BVM) unit or a demand-valve ventilator (DVR) unit; Equipped with the lower segment is configured to be attached to the vacuum tube and to apply a negative pressure to an interior of the shield body; A vacuum shield assembly, wherein the shield body and the retention assembly are collectively positionable into and out of operative and non-operative positions. Article 41 1. A system configured to remove exhaled air from a patient wearing a medical mask, comprising: Vacuum tubes and a vacuum shield assembly positionable on the patient wearing the medical mask, the vacuum shield assembly including a shield body; a holding assembly configured to hold the vacuum tube and components of the medical mask; A vacuum unit; an air filter operably disposed inside the vacuum tube; Equipped with the vacuum unit is disposed in fluid communication with the vacuum tube, the interior of the shield body, and the vacuum unit; The system, wherein the vacuum unit, the vacuum tube, and the shield body are collectively positionable in and out of operative and non-operative orientations. Article 42 In the operating orientation, 42. The system of claim 41, wherein the vacuum unit is activated to apply a negative pressure to the inside of the shield body to at least partially remove exhaled air from the patient. Article 43 42. The system of claim 41, wherein the air filter is operably positioned inside the vacuum tube adjacent to the vacuum unit. Article 44 The shield body has a recessed shape, the holding assembly of the vacuum shield assembly is configured to hold a vacuum tube and an oxygen supply tube or a nebulizer unit of the medical mask; the shield assembly further comprising a lower segment having an opening and disposed along a lower periphery of the shield body, the lower segment configured to be attached to the vacuum tube and configured to apply a negative pressure to an interior of the shield body; 42. The system of claim 41, wherein the shield body, the vacuum tube, and the retention assembly are collectively positionable in and out of operative and non-operative positions. Article 45 In the operating position: the shield body is at least partially attached to the patient's head; the vacuum tube is operably connected to the shield body; 45. The vacuum shield assembly of claim 44, wherein the vacuum tube and the components of the medical mask are disposed on the retaining assembly. Article 46 45. The vacuum shield assembly of claim 44, wherein the concave shape of the shield body is dimensioned and configured to at least partially surround the medical mask. Article 47 45. A vacuum shield assembly as described in clause 44, wherein the lower segment has a substantially curved shape and the shield body further comprises an edge defining a substantially flat side profile of the shield body, the edge having a semi-oval shape. Article 48 Clause 45. The vacuum shield assembly of clause 44, wherein the shield body further comprises a connecting portion disposed in fluid communication with the opening of the shield body. Article 49 the retention assembly: a retaining component configured and dimensioned to retain the connecting portion of the shield body; a lower section of the retention component configured and dimensioned to be attached to a vacuum tube; a holding frame connected to the holding component and configured to hold the oxygen supply tube or the nebulizer unit of the medical mask; 45. The vacuum shield assembly of claim 44, comprising: Article 50 49. The vacuum shield assembly of claim 49, wherein the retaining frame has a semi-cylindrical shape. Article 51 A vacuum shield assembly as described in clause 49, wherein the holding assembly comprises a first closure mechanism comprising a plurality of notches, and the holding assembly further comprises a second closure mechanism comprising a snap mechanism configured and dimensioned to operate together with the plurality of notches to adjust the size of the holding frame. Article 52 1. A system configured to remove exhaled air from a patient wearing a medical mask, comprising: Vacuum tubes and a holding assembly configured to hold the vacuum tube and an oxygen delivery tube or nebulizer unit of the medical mask; a vacuum shield assembly positionable over the patient wearing the medical mask, a shield body having a recessed shape; a lower segment having an opening, the lower segment being disposed along a lower periphery of the shield body, the lower segment being configured to be attached to the vacuum tube and to apply a negative pressure to the interior of the shield body; a vacuum shield assembly, the shield body, the vacuum tube, and the retention assembly being collectively positionable into and out of an operative position and a non-operative position; A vacuum unit; an air filter operably positioned inside the vacuum tube adjacent to the vacuum unit; Equipped with the vacuum tube is positioned in fluid communication with an interior of the vacuum unit and in fluid communication with an interior of the shield body around the opening; The system, wherein the vacuum unit, the vacuum tube, and the vacuum shield are collectively positionable in and out of operative and non-operative orientations. Article 53 In the operating position: the shield body is at least partially attached to the patient's head; the vacuum tube is operably connected to the shield body; 53. The system of claim 52, wherein the vacuum tube and the components of the medical mask are disposed on the holding assembly. Article 54 In the operating orientation, the shield body, the vacuum tube, and the retention assembly are disposed in the operating position; 53. The system of claim 52, wherein the vacuum unit is activated to apply negative pressure to the inside of the vacuum tube and the inside of the shield body to at least partially remove exhaled air from the patient wearing the medical mask. Article 55 54. The system of claim 53, wherein the vacuum unit comprises a housing and a battery-operated motorized vacuum device disposed inside the housing. Article 56 54. The system of claim 53, wherein the vacuum unit comprises a housing, the housing having at least one aperture configured to allow filtered air to exit the housing. Article 57 1. A method for removing exhaled air from a patient wearing a medical mask, comprising: (i) providing a system configured to remove exhaled air from the patient wearing the medical mask, the system comprising: Vacuum tubes and a vacuum shield assembly positionable on the patient wearing the medical mask, the vacuum shield assembly including a shield body; a holding assembly configured to hold the vacuum tube and components of the medical mask; A vacuum unit; an air filter operably disposed inside the vacuum tube; Equipped with the vacuum tube is disposed in fluid communication with the interior of the shield body and the vacuum unit; the vacuum tube, the shield body, and the vacuum unit are collectively positionable in and out of an operative orientation and a non-operative orientation; (ii) placing the shield body onto the retention assembly; (iii) placing the components of the medical mask onto the retention assembly; (iv) placing the vacuum tube in fluid communication with an interior of the shield body; (v) at least partially placing the medical mask on the patient's head; (vi) at least partially placing the shield body around the medical mask; A method comprising: Article 58 (v) The method of clause 57, wherein the step of at least partially positioning the shield body around the medical mask includes at least partially positioning the shield body around the medical mask and in proximity to the patient's face to form a sealing zone. Article 59 (vii) placing the vacuum tube in fluid communication with the interior of the vacuum unit; (viii) activating the vacuum unit to apply negative pressure to the containment zone to remove exhaled air from the patient; 58. The method of clause 57, further comprising: Article 60 (viii) The method of clause 59, wherein the step of activating the vacuum unit to apply negative pressure to the sealing zone to remove exhaled air from the patient includes activating the vacuum unit to apply negative pressure to the inside of the vacuum tube and the inside of the shield body to remove exhaled air from the patient between the inside of the shield body and the face of the patient. Article 61 1. A shield assembly configured for inserting an intubation device and configured to at least partially reduce exhaled particle emissions from a patient, comprising: a shield body having a top surface and a bottom surface; an upper portion disposed at a distal end of the shield body; a first side segment and a second side segment, each disposed at a proximal end of the shield body; Equipped with the top and the bottom surface of the shield body collectively define a sealing area; the shield body including an opening configured and dimensioned for insertion of the intubation device; the shield assembly further comprising at least one vacuum opening disposed in the shield body and configured to be attached to a vacuum tube; A shield assembly, wherein the shield body is positionable in and out of an operative position and a non-operative position. Article 62 An intubation assembly as described in clause 61, wherein each of the first side segment and the second side segment are spaced apart from each other, and the first side segment and the second side segment collectively define an aperture. Article 63 63. The shield assembly of claim 62, wherein the aperture is configured and dimensioned to allow access to the sealed area by a user's hand and arm. Article 64 Clause 63. The shield assembly of clause 62, wherein the first side segment, the second side segment, and the shield body collectively define a curved portion about the aperture. Article 65 Clause 65. The shield assembly of clause 64, further comprising a reinforcing structure disposed about the proximal end of the shield body, the reinforcing structure configured to at least partially reduce bending of the shield body. Article 66 Clause 66. The shield assembly of clause 65, wherein the reinforcing structure comprises a profile configured to accommodate the curvature around the aperture. Article 67 Clause 62. The shield assembly of clause 61, further comprising an overlap portion formed around the distal end of the shield body, the overlap portion configured to at least partially reduce bending of the shield body. Article 68 68. The shield assembly of claim 67, wherein the overlapping portion is at least partially defined by overlapping of the shield body and the upper portion. Article 69 Clause 62. The shield assembly of clause 61, further comprising a reinforcing structure disposed about the proximal end of the shield body, the reinforcing structure configured to at least partially reduce bending of the shield body. Article 70 62. A shield assembly as described in clause 61, wherein in the operating position, the intubation device is positioned over the shield opening and in the patient's mouth, with the interior of the shield body facing the patient. Article 71 62. The shield assembly of claim 61, further comprising a vacuum connection portion disposed around the vacuum opening, the vacuum connection portion configured and dimensioned to be attached to a vacuum tube. Article 72 72. The shield assembly of claim 71, wherein in the operating position, the vacuum tube applies negative pressure around the sealing area to at least partially remove exhaled air from the patient between the shield body and the medical mask. Article 73 62. The shield assembly of claim 61, further comprising at least one slot configured to allow insertion of an endotracheal tube into the sealing area. Article 74 Clause 62. The shield assembly of clause 61, wherein the shield body has a substantially arcuate shape. Article 75 62. The shield assembly of claim 61, wherein the upper portion comprises a flexible material. Article 76 Clause 62. The shield assembly of clause 61, wherein each of the first side segment and the second side segment comprises a flexible material. Article 77 Clause 62. The shield assembly of clause 61, further comprising an offset structure disposed on the bottom surface of the shield body, the offset structure configured to at least partially provide spacing between the shield body and the patient. Article 78 Clause 78. The shield assembly of clause 77, wherein the offset structure is disposed at least partially about the top portion of the shield body. Article 79 Clause 78. The shield assembly of clause 77, wherein the offset structure is disposed at least partially around each of the first side segment and the second side segment. Article 80 1. An intubation assembly configured to insert an intubation device and configured to at least partially reduce exhaled particle emissions from a patient, comprising: an intubation device assembly comprising a sleeve configured and dimensioned to receive an intubation device therein, the sleeve further configured and dimensioned to be inserted into a patient's mouth; a shield body having a top surface and a bottom surface; an upper portion disposed at a distal end of the shield body; a first side segment and a second side segment, each disposed at a proximal end of the shield body; Equipped with the top and the bottom surface of the shield body collectively define a sealing area; the shield body has an opening for inserting the sleeve; the intubation assembly further comprising at least one vacuum opening disposed in the shield body and configured to be attached to a vacuum tube; An intubation assembly, wherein the shield body and the sleeve are collectively positionable into and out of operative and inoperative positions. Article 81 81. The intubation assembly of clause 80, wherein the sleeve comprises a body configured and dimensioned to correspond to a body of the intubation device. Article 82 81. An intubation assembly as described in clause 80, wherein the intubation device assembly comprises an audiovisual component. Article 83 81. An intubation assembly as described in clause 80, wherein the shield body includes a sleeve retainer disposed on the bottom surface, the sleeve retainer configured and dimensioned to direct the sleeve into the patient's mouth. Article 84 An intubation device assembly as described in clause 83, wherein the sleeve retainer comprises at least one expandable component, the at least one expandable component defined along a length of the sleeve retainer and configured to at least partially permit movement of the sleeve within the shield body. Article 85 1. A method of at least partially reducing particle emissions from a patient using an intubation assembly, comprising: Providing an intubation shield assembly, said intubation shield assembly comprising: an intubation device assembly comprising a sleeve configured and dimensioned to receive an intubation device therein, the sleeve further configured and dimensioned to be inserted into the patient's mouth; a shield body having a top surface and a bottom surface; an upper portion disposed at a distal end of the shield body; a first side segment and a second side segment, each disposed at a proximal end of the shield body; Equipped with the top and bottom surfaces of the shield body collectively define a sealing area; the shield body has an opening for inserting the sleeve; the intubation shield assembly further comprising at least one vacuum opening disposed in the shield body and configured to be attached to a vacuum tube; the shield body and the sleeve are collectively positionable into and out of operative and non-operative positions; placing an intubation device within the sleeve; inserting the sleeve through the opening in the shield body; inserting a user's hand into the sealed area and grasping the sleeve; positioning the sleeve in the patient's mouth; placing the shield assembly and the intubation device assembly in the operative position; A method comprising: Article 86 1. A system configured to remove exhaled air from a patient, comprising: Vacuum tubes and 1. A shield assembly configured for inserting an intubation device, comprising: a shield body having an opening configured and dimensioned for insertion of the intubation device; and At least one vacuum opening disposed in the shield body and configured to be attached to the vacuum tube a shield assembly comprising: a vacuum unit disposed in fluid communication with an interior of the vacuum tube and an interior of the shield body; a filter operably disposed on the interior of the vacuum tube; Equipped with The system, wherein the vacuum tube, the shield body, and the vacuum unit are collectively positionable in and out of operative and non-operative orientations. Article 87 87. The system of clause 86, wherein the shield body is positionable in and out of an operative position and a non-operative position. Article 88 88. The system of clause 87, wherein in the operating position, the intubation device is positioned over the shield opening and in the patient's mouth, with the interior of the shield body facing the patient. Article 89 The system described in clause 87, wherein in the operating position, the intubation device is positioned over the shield opening and within the patient's trachea, with the interior of the shield body positioned facing the patient's neck. Article 90 89. The system of claim 88, wherein in the operating position, the intubation device is positioned over the shield opening and through an opening in the patient's neck into the patient's trachea. Article 91 In the operating orientation, the shield body is positioned in an operative position with the intubation device positioned over the shield opening and in the patient's mouth and with the interior of the shield body facing the patient; 87. The system of claim 86, wherein the vacuum unit is operable to apply negative pressure to the inside of the shield body to at least partially remove exhaled air from the patient. Article 92 In the operating orientation, the shield body is positioned in an operating position, with the intubation device positioned over the shield opening and in the patient's airway and the interior of the shield body positioned against the patient's neck; 87. The system of claim 86, wherein the vacuum unit is operable to apply negative pressure to the inside of the shield body to at least partially remove exhaled air from the patient. Article 93 87. The system of claim 86, wherein the filter comprises an air filter operably positioned inside the vacuum tube adjacent to the vacuum unit, the vacuum tube operably connected to the vacuum unit and the shield body. Article 94 The shield body of the shield assembly a top surface and a bottom surface; an upper portion disposed at a distal end of the shield body; a first side segment and a second side segment, each disposed at a proximal end of the shield body; and 87. The system of clause 86, wherein the top and bottom surfaces of the shield body collectively define a sealing area. Article 95 An intubation assembly as described in clause 94, wherein each of the first side segment and the second side segment are spaced apart from one another, and the first side segment and the second side segment collectively define an aperture configured and dimensioned to allow access to the sealed area by a user's hand and arm. Article 96 Clause 95. The shield assembly of clause 94, further comprising a reinforcing structure disposed around the proximal end of the shield body, the reinforcing structure configured to at least partially reduce bending of the shield body. Article 97 Clause 95. The shield assembly of clause 94, further comprising an overlap portion formed around the distal end of the shield body, the overlap portion configured to at least partially reduce bending of the shield body. Article 98 Clause 95. The shield assembly of clause 94, wherein in the operational orientation, the vacuum unit is activated to apply a negative pressure around the sealing area to at least partially remove exhaled air from the patient between the shield body and the patient. Article 99 Clause 95. The shield assembly of clause 94, further comprising at least one slot configured to allow insertion of an endotracheal tube into the sealing area. Article 100 1. A system configured to remove exhaled air from a patient, comprising: Vacuum tubes and an intubation device assembly comprising a sleeve configured and dimensioned to receive an intubation device therein, the sleeve further configured and dimensioned to be inserted into the patient's mouth; a shield assembly configured to receive the sleeve, a shield body having a top surface and a bottom surface, the shield body further comprising a flexible material; an upper portion including a flexible material and disposed at a distal end of the shield body; a first side segment and a second side segment, each disposed at a proximal end of the shield body; Equipped with the top and the bottom surface of the shield body collectively define a sealing area; the shield body including an opening configured and dimensioned to receive the sleeve; the shield assembly further comprising at least one vacuum opening disposed in the shield body and configured to be attached to a vacuum tube; a shield assembly, the shield body and the sleeve being collectively positionable into and out of an operative position and a non-operative position; A vacuum unit; an air filter operably disposed inside the vacuum tube; Equipped with The system, wherein the vacuum tube, the shield body, and the vacuum unit are collectively positionable in and out of operative and non-operative orientations. Article 101 The system described in clause 100, wherein the sleeve comprises a sleeve body configured and dimensioned to correspond to the sleeve body of the intubation device, and the intubation device assembly comprises an audiovisual component. Article 102 The system described in clause 100, wherein the shield body includes a sleeve retainer disposed on the bottom surface, the sleeve retainer configured and dimensioned to direct the sleeve into the patient's mouth. Article 103 The system described in Clause 100, wherein the sleeve retainer comprises at least one expandable component, the at least one expandable component defined along the length of the sleeve retainer and configured to at least partially allow movement of the sleeve within the shield body. Article 104 1. A method for removing exhaled air from a patient, comprising: (i) providing a system configured to remove exhaled air from the patient, the system comprising: Vacuum tubes and 1. A shield assembly configured for insertion of an intubation device, comprising: a shield body including at least an opening configured and dimensioned for insertion of said intubation device; at least one vacuum opening disposed in the shield body and configured to be attached to the vacuum tube; a shield assembly comprising: A vacuum unit; an air filter operably disposed inside the vacuum tube; and (ii) attaching the vacuum tube to the at least one vacuum opening; (iii) applying a negative pressure to the inside of the shield body using the vacuum unit; (iv) inserting the intubation device into the patient's mouth; (v) inserting an endotracheal tube through the shield body and positioning the endotracheal tube over the patient's trachea; (vi) removing the vacuum shield from the patient; A method comprising: Article 105 (iv) The method of clause 104, wherein the step of inserting the intubation device into the patient's mouth includes inserting the intubation device into the patient's mouth while the shield body is positioned adjacent to the patient's face, and applying negative pressure between the shield body and the patient's face using the vacuum unit.

Claims

1. 1. A vacuum shield assembly positionable on a patient wearing a medical mask and configured to remove exhaled air from the patient, the vacuum shield assembly comprising: a shield body having a recessed shape; a lower segment disposed along a lower periphery of the shield body and comprising an opening in the shield body; a holding assembly configured to hold a vacuum tube and an oxygen supply tube or a nebulizer unit of the medical mask; the lower segment is configured for attachment to the vacuum tube and configured to apply a negative pressure to an interior of the shield body; the shield body and the retention assembly move between an operative position and a non-operative position; the shield body further comprising a connecting portion disposed in fluid communication with the opening of the shield body; the retention assembly: a retaining component configured and dimensioned to retain the connecting portion of the shield body; a lower section of said retention component configured and dimensioned for attachment of a vacuum tube; a holding frame connected to the holding component and configured to hold the oxygen supply tube or the nebulizer unit of the medical mask; A vacuum shield assembly comprising a first closure mechanism and a second closure mechanism cooperatively configured to adjust an inner region of the holding frame, each of the first closure mechanism and the second closure mechanism being disposed on the holding frame.

2. The vacuum shield assembly of claim 1 , wherein the concave shape of the shield body is sized and configured to at least partially surround the medical mask.

3. The vacuum shield assembly of claim 2 , wherein the shield body is configured to be positioned adjacent to and face the medical mask in the operating position.

4. The vacuum shield assembly of claim 3 , wherein the recessed shape is configured to define a space around the oxygen delivery tube or the nebulizer unit of the medical mask.

5. 10. The vacuum shield assembly of claim 1, wherein in the operating position, the vacuum tube is further configured to apply a negative pressure to an interior of the shield body to at least partially remove exhaled air from the patient between the shield body and the medical mask.

6. The vacuum shield assembly of claim 1 , wherein the lower segment has a substantially curved shape.

7. The vacuum shield assembly of claim 1 , wherein the shield body further comprises an edge that defines a substantially flat side profile of the shield body.

8. The vacuum shield assembly of claim 7 , wherein the edge has a semi-oval shape.

9. The vacuum shield assembly of claim 1 , wherein the retaining frame has a semi-cylindrical shape.

10. 2. The vacuum shield assembly of claim 1, wherein the retaining frame has a semi-cylindrical shape, the first closure mechanism comprises a plurality of notches, and the second closure mechanism comprises a snap mechanism configured and dimensioned to operate together with the plurality of notches to adjust the sleeve size of the retaining frame.

11. 2. The vacuum shield assembly of claim 1, wherein the first closure mechanism comprises a first flap and the second closure mechanism comprises a second flap, the first flap and the second flap cooperatively configured to adjust the inner region of the retaining frame.

12. The vacuum shield assembly of claim 1 , comprising at least one holding segment disposed on the holding frame, the at least one holding segment configured to at least partially hold the nebulizer unit.

13. 13. The vacuum shield assembly of claim 12, wherein the at least one retention segment includes a latch disposed at an upper end thereof, the latch configured to at least partially reduce vertical movement of the nebulizer unit.

14. The vacuum shield assembly of claim 1 , wherein the retention component comprises an upper section configured and dimensioned to retain the connecting portion of the shield body.

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