Patent Publication Number: US-2022226589-A1

Title: Vacuum shield assembly for attachment to medical masks

Description:
FIELD OF INVENTION 
     The present invention relates to attachments to masks for medical procedures. 
     BACKGROUND 
     Medical masks may be used for or for nebulizing a patient or used for Non-Invasive Positive Pressure Ventilation (NIPPV), Bi-level Positive Airway Pressure (BIPAP), Bag-Valve-Mask Resuscitator (BVM), Demand-Valve Resuscitator (DVR), or Constant Positive Airway Pressure (CPAP). Of the masks that currently exist, none are believed to provide a truly efficient means for vacuuming air to create negative pressure, or for implementing a nebulizing or positive pressure procedure and at the same time using negative pressure to vacuum exhaled air from the patient. Accordingly, the industry would benefit by providing a vacuum shield assembly for attachment to a medical mask that may be used for vacuuming exhaled air from patient during nebulization, BIPAP, CPAP, or the delivery of oxygen, or to another type of medical mask, including a face mask, a face tent, a Venturi mask, and/or a non-rebreather. Such a vacuum shield assembly would provide the added benefit of at least partially reducing contact to the mask and/or face of the patient, which may help to counter the risk of contagion of airborne illnesses, e.g., influenza, covid-19, etc., providing added protection to medical providers and staff involved in these procedures and in at least partially reducing the development of fomites from exhaled or aerosolized particles or droplets. Additionally, a benefit in the industry would be provided if such a vacuum shield assembly would be disposable as it would further reduce such risk of contagion. An even further benefit would be provided if such a vacuum shield assembly would be sufficiently versatile to be used as a primary and/or a secondary air vacuuming component, and/or a nebulizing component. Yet a further benefit would be realized if this vacuum shield assembly would be provided in different shapes and sizes to correspond to the geometry and size of the underlying face mask. 
     SUMMARY 
     The present invention is directed to a vacuum shield assembly intended for attachment to an existing mask. As used herein, an “existing mask” refers to a suction mask, a mask configured for attachment to a nebulizer, BIPAP, CPAP, BVM, DVR or another related mask, including a mask configured for the delivery of oxygen to the patient, that is already disposed on the head and/or face of a patient. Accordingly, the vacuum shield assembly of the present invention may serve as a primary and/or a secondary suction or vacuum mechanism, which in some embodiments may be connected to a negative pressure vacuum. The vacuum shield assembly generally comprises a shield body and a retaining assembly. The retaining assembly may be used to connect the vacuum shield to a vacuum tube connected to a negative pressure vacuum. The retaining assembly may also be attached to a nebulizer unit or component thereof, or to the oxygen supply tube of a BIPAP or CPAP mask. Additionally, the shield body may comprise a lower segment. The shield body may be configured with or without a circular access opening in the convexity of the shield body that will allow a BVM, or DVR to connect to an existing mask by way of the access opening in order to facilitate the vacuuming of exhaled air during said procedures. The lower segment may further define an interior or inside of the shield body and may comprise a connecting portion disposed in fluid communication with the retaining assembly and the vacuum tube. The shield body may be configured and dimensioned to correspond to the geometry of the existing mask. As an example, the shield body may comprise a substantially concave configuration and/or a variety of shapes, including, but not limited to, a substantially triangular or substantially ovoidal shape. However, other shapes of the shield body are possible, which may also to correspond to the shape of the existing mask and/or the shape of the face and/or head of the patient. As such, it is within the scope of the present invention that the vacuum shield assembly according to the present invention at least partially remove exhaled infectious particles, for example, from a patient that has a respiratory illness. As a result, it is contemplated that such increased removal of exhaled infectious particles at least partially reduce the risk of contagion of medical practitioners and staff assisting with these types of procedures and/or the contamination of physical objects in the vicinity (fomites). 
     Further embodiments of the present invention comprise a system configured to remove exhaled air from a patient wearing a medical masks. In such embodiments, it is contemplated that a portable vacuum unit be provided and connected to a vacuum tube that itself connects to the vacuum shield assembly, i.e., to the shield body, to create a negative pressure on an interior of the shield body and remove exhaled air. The innovative system may be provided with a retaining assembly, if it is desirable to connect to a component of an existing medical mask, or without a retaining assembly, in embodiments where it is desirable to dispose the shield body directly on the face of the patient. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of one embodiment of the vacuum shield assembly according to the present invention attached to nebulizer mask. 
         FIG. 2  is a perspective view of another embodiment of the vacuum shield assembly according to the present invention for use with a nebulizer mask. 
         FIG. 3  is a perspective view of yet another embodiment of the vacuum shield assembly according to the present invention for use with a nebulizer mask. 
         FIG. 4  is a perspective and partially exploded view of a further embodiment of the vacuum shield assembly according to the present invention. 
         FIG. 5  is a perspective view of one embodiment of a retaining assembly of the vacuum shield assembly according to the present invention. 
         FIG. 6  is a perspective view of one embodiment of the vacuum shield assembly according to the present invention attached to a BIPAP or CPAP mask. 
         FIG. 7  is a perspective view of another embodiment of the vacuum shield assembly according to the present invention for use with a BIPAP or CPAP mask. 
         FIG. 8  is a perspective view of yet another embodiment of the vacuum shield assembly according to the present invention for use with a BIPAP or CPAP mask. 
         FIG. 9  is a perspective and partially exploded view of an even further embodiment of the vacuum shield assembly according to the present invention. 
         FIG. 10  is a perspective view of yet a further embodiment of the vacuum shield assembly according to the present invention. 
         FIG. 11  is a perspective view of another embodiment of a retaining assembly of the vacuum shield assembly according to the present invention. 
         FIG. 12  is a perspective view of one embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a second opening. 
         FIG. 12A  is a perspective view of one embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a second opening. 
         FIG. 12B  is a perspective view of another embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a second opening. 
         FIG. 12C  is a perspective view of even another embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a second opening. 
         FIG. 12D  is a perspective view of yet another embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a second opening and connected to a BVM or DVR unit. 
         FIG. 13A  is a perspective view of one embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a vacuum attachment disposed on the shield body. 
         FIG. 13B  is a perspective view of another embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a vacuum attachment disposed on the shield body. 
         FIG. 14A  is a perspective view of yet another embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a vacuum attachment disposed on the shield body. 
         FIG. 14B  is a perspective view of an even further embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a vacuum attachment disposed on the shield body. 
         FIG. 15A  is a perspective view of one embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a vacuum attachment disposed on the shield body and connected to a BVM or DVR unit. 
         FIG. 15B  is a perspective view of another embodiment of a shield body of the vacuum shield assembly according to the present invention comprising a vacuum attachment disposed on the shield body and connected to a BVM or DVR unit. 
         FIG. 16A  is a top view of one embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. 
         FIG. 16B  is a top view of another embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. 
         FIG. 16C  is a top view of a further embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. 
         FIG. 16D  is a top view of yet another embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. 
         FIG. 16E  is a top view of an even further embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. 
         FIG. 16F  is a top view of another embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. 
         FIG. 16G  is a top view of a further embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. 
         FIG. 16H  is a top view of an even further embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. 
         FIG. 16I  is a top view of yet another embodiment of a vacuum attachment according to the vacuum shield assembly of the present invention. 
         FIG. 17  is a perspective view of one embodiment of the system according to the present invention. 
         FIG. 18A  is a perspective view of disassembled components of one embodiment of the system according to the present invention. 
         FIG. 18B  is a perspective view of another embodiment of the system according to the present invention. 
         FIG. 19A  is a perspective side view of one embodiment of the shield body and retaining assembly of the system according to the present invention. 
         FIG. 19B  is a perspective side view of another embodiment of the shield and retaining assembly of the system according to the present invention before attachment to a nebulizer. 
         FIG. 19C  is a perspective side view of yet another embodiment of the shield and retaining assembly of the system according to the present invention attached to a nebulizer. 
         FIG. 19D  is a perspective side view of a further embodiment of the shield and retaining assembly of the system according to the present invention disposed on an existing medical mask attached to a patient. 
         FIG. 20A  is a perspective side view of one embodiment of the shield body and retaining assembly of the system according to the present invention. 
         FIG. 20B  is a perspective side view of another embodiment of the shield and retaining assembly of the system according to the present invention before attachment to an oxygen supply tube. 
         FIG. 20C  is a perspective side view of yet another embodiment of the shield and retaining assembly of the system according to the present invention attached to an oxygen supply tube. 
         FIG. 20D  is a perspective side view of a further embodiment of the shield and retaining assembly of the system according to the present invention disposed on an existing medical mask attached to a patient. 
         FIG. 21A  is a perspective view of a portion of one embodiment of the system according to the present invention comprising a strap for an existing mask and a retaining assembly attached to a nebulizer. 
         FIG. 21B  is a perspective view of a portion of another embodiment of the system according to the present invention comprising a strap for an existing mask and a retaining assembly attached to a nebulizer. 
         FIG. 21C  is a perspective view of a portion of yet another embodiment of the system according to the present invention comprising a strap for an existing mask and a retaining assembly attached to a nebulizer. 
         FIG. 21D  is a perspective view of one embodiment of the system according to the present invention comprising a body shield attached to a medical mask and a patient. 
         FIG. 22  is a diagrammatic representation of one embodiment of the method according to the present invention for removing exhaled air from a patient. 
     
    
    
     DETAILED DESCRIPTION 
     With initial reference to  FIGS. 1-4, 6-10 and 12 , the present invention is directed to a vacuum shield assembly  10 . The vacuum shield assembly  10  according to the present invention is intended to be disposed on the head and/or face of a patient that is already wearing a medical mask, and is intended to at least partially extract exhaled air from the patient. For example, and as is perhaps best shown in  FIGS. 1 and 6 , the vacuum shield assembly  10  may be attached to a mask already disposed on the head and/or face of a patient. The vacuum shield assembly  10  may be connected to a vacuum tube such that it may at least partially extract exhaled air from the patient, including, for example, between the already disposed medical mask and the inside of a shield body  11  of the vacuum shield assembly  10 . The vacuum shield assembly  10  may serve as a primary suction or vacuum mechanism, or alternatively, as secondary suction or vacuum mechanism. As an example, and as is shown in  FIGS. 6-8 , the vacuum shield assembly  10  may be attached to a BIPAP or CPAP mask, or to a mask configured for oxygen delivery, which is already disposed on the head and/or face of a patient. Other possible existing medical masks that could be used in connection with the present invention include a face mask, a face tent, a Venturi mask, and/or a non-rebreather. As a further example, and as is shown in  FIGS. 1-3 , the vacuum shield assembly  10  may be attached to a nebulizing mask already disposed on the head and/or face of a patient. 
     As shown at least in the illustrative embodiments of  FIGS. 1-4, 6-10 and 12 , the vacuum shield assembly  10  comprises a shield body  11 . The vacuum shield assembly  10  also generally comprises a retaining assembly  20 . The retaining assembly  20  is generally connected to the shield body  11  as well as to a vacuum tube. As used herein, the term “vacuum tube” refers to a conduit, hose, or other related structure that may convey air from a patient and/or mask to another location, and which may be connected to a negative pressure vacuum. For example, the vacuum tube  40  may comprise a 22 millimeter hose, which may comprise a length of about 8 feet. As shown at least in  FIGS. 2 and 7 , the retaining assembly  20  may be used to interconnect the shield body  11  to a vacuum tube. The structure of the retaining assembly  20  should define a fluid communication between an inside of the shield body  11  and the vacuum tube. As such, the shield body  11  may create a negative pressure on an interior thereof to remove the air between the medical mask, the face and/or head of the patient, and the interior or inside of the shield body  11 . It is contemplated that a patient that is wearing a BIPAP or CPAP mask, or a nebulizing mask, be able to exhale through the mask, and that at least a portion of this exhaled air may be captured by the negative pressure generated by the shield body  11  and the vacuum tube. 
     As is shown in  FIGS. 1-2 and 6-7  the retaining assembly  20  may also be used to connect the shield body  11  and/or vacuum tube to an oxygen supply tube and/or a nebulizing unit or component thereof. Shield bodies of different sizes may be attached to a retaining assembly  20 , for example, by inserting a connecting portion  18  into an upper section  21 ″ of the retaining component  21 , or to the retaining component  21  directly, which will be explained later. As such, it may be possible to switch between shield bodies of different sizes according to a specific need, e.g., air suction, nebulization, etc., and/or geometrical constraints, e.g., the size of the head of the patient. 
     With reference to  FIGS. 12A-15B , the shield body  11  according to the inventive vacuum shield assembly  10  may be provided with a second opening  16  configured and dimensioned to accommodate a medical mask. With specific reference to  FIGS. 12B-12D  and  14 A- 15 B, the second opening  16  may be configured and dimensioned so that a connecting segment of an existing medical mask, e.g., a demand-valve resuscitator (DVR) mask or a bag-valve-mask (BVM) resuscitator mask, may be inserted there through, e.g., as shown in  FIGS. 12D, 15A and 15B . Furthermore, the shield body  11  may be provided with a vacuum attachment  17 , which may at least partially define or otherwise form a seal between an outer surface  11 ′ and an inner surface  11 ″ of the shield body  11 . Also, the second opening  16  and/or vacuum attachment  17  may be operatively configured and dimensioned to substantially define a seal between the second opening  16  and the connecting segment of the medical mask. Accordingly, 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 also possible. 
     As represented in at least  FIG. 15A , a grommet seal may be co-molded to the shield body  11 . This is advantageous as it may at least partially reduce the time, effort, and/or expense involved in manufacturing a vacuum shield assembly  10  with a vacuum attachment. Further, a grommet seal co-molded to the shield body may provide for a robust construction, which is also advantageous. Alternatively, as represented at least in  FIG. 15B , a grommet seal may be inserted into the shield body, which is referred to as an insert-molding. Further, the vacuum attachment  17  may comprise a variety of materials, including, but not necessarily limited to silicone, rubber, plastics, elastomeric polymers, seals, sealants, and/or other related structures. As such, the second opening  16  may at least partially allow an operative communication between the existing mask, i.e., BVM or DVR, through an interior of its connecting segment, and the underlying BVM or DVR unit. It is contemplated that the opening  16  permit at least a fluid communication between the existing mask and the BVM or DVR unit, i.e., via the interior of the connecting segment of the mask, which passes through the second opening  16 . 
     With reference again to  FIGS. 12A-15B , the second opening  16  may be disposed on the shield body  11  at a location that corresponds to the location of the medical mask. Generally, during some BVM and/or DVR procedures some air may leak between the face of the patient and the mask, which is attached to the patient, for example, as the patient inhales or exhales air. In such BMV and/or DVR procedures, the inventive vacuum shield assembly  10  is intended to capture exhaled air that may leak out of the BVM and/or DVR mask. As such, the second opening  16  may be disposed substantially around a middle section of the shield body  11  and/or above the first opening  13 . This would allow for placement of the vacuum shield assembly  10  on a location that corresponds to location of the connecting segment of the medical mask. Moreover, the second opening  16  and/or vacuum attachment  17  may be disposed on a height along the shield body  11  that corresponds to the approximate location of the existing medical mask. As may be appreciated from the illustrative embodiments as shown in  FIGS. 15A and 15B , exhaled air may exit through the existing mask, i.e. through opening  13  of the shield body  11 . In addition to, or in lieu of this, exhaled air may also exit through a vacuum tube operatively connected to the existing mask and connecting segment, which passes through the second opening  16 . 
     As is perhaps best shown in  FIGS. 16A-16I , features of the present invention comprise providing a vacuum attachment  17  comprising a grommet configuration. As shown in  FIGS. 16A-16I , the vacuum attachment  17  may comprise a substantially circular shape configured to correspond to the diameter and/or size of the second opening  16 . For example the diameter of an outer perimeter or recessed portion of the vacuum attachment  17  may be configured to correspond to the dimension and/or size of the second opening  16 . Additionally, the circular shape of the vacuum attachment  17  may be configured and dimensioned to correspond to the diameter and/or size of the connecting segment of the medical mask, for example around an inner perimeter of the vacuum attachment  17 . As shown in  FIGS. 16F and 16I , a vacuum attachment  17  may be provided comprising a grommet configuration with an aperture. As such, when the vacuum attachment  17  is disposed around the second opening  16 , the aperture of the vacuum attachment  17  permits a fluid communication between the outer surface  11 ′ and inner surface  11 ″ through the second opening  16 . As shown in  FIG. 16F , the vacuum attachment  17  may comprise a tear away recessed pocket. Conversely, as shown in the illustrative embodiments of  FIGS. 16A-16E and 16G-16H , the vacuum attachment may comprise a grommet configuration that creates a cover around the interior perimeter of the vacuum attachment  17 . The cover may comprise a plurality of adjacently disposed segments  17 ′, which may be collectively structured to form a substantially flat surface in an inoperative disposition of the connecting segment of the medical mask, i.e., when the connecting segment is not inserted around the second opening  16 . The plurality of adjacently disposed segments  17 ′ may be collectively structured to bend at least in an opposite direction to the movement of the connecting segment of the medical mask. 
     As is shown in the illustrative embodiments of  FIGS. 15A and 15B , once the connecting segment of the medical mask is inserted through the second opening  16 , the plurality of adjacently disposed segments  17 ′ may bend towards the outer surface  11 ′ allowing the connecting segment to pass there through. Conversely, if the connecting segment is removed, the plurality of adjacently disposed segments  17 ′ may return to their natural and/or initial positon, forming once again the cover around the aperture of the vacuum attachment  17 . As such, a vacuum shield assembly  10  according to the present invention may be used in connection with one BVM and/or DVR procedure, then later removed, and used in a subsequent BVM and/or DVR procedure. The vacuum shield assembly  10  may also be used in connection with a procedure that uses the second opening  16 , i.e., a BVM and/or DVR procedure, and may later be used in a subsequent procedure that does not use the second opening  16 , or vice versa. Or alternatively, a vacuum shield assembly  10  comprising a second opening  16  may also be used in connection with a procedure that does not need the second opening  16 . Thus, a vacuum shield assembly  10  comprising a second opening  16  may be attached to a medical mask that is not a BMV or DVR mask. As such, the plurality of adjacently disposed segments  17 ′ may naturally form a cover, which should essentially function as a seal between the outer surface  11 ′ and inner surface  11 ″. Said differently, the plurality of adjacently disposed segments  17 ′, in their natural position, should at least partially reduce leakage of exhaled air from the inner surface  11 ″ to the outer surface  11 ′. As such, exhaled air may be retained on an interior of the shield body  11  and removed via the connecting portion  18  and/or oxygen tube. 
     As is also seen in  FIGS. 16A-16E and 16G-16H , each one of the plurality of adjacently disposed segments  17 ′ may comprise a substantially triangular shape. As such, when disposed around the inner perimeter of the vacuum attachment  17 , they may substantially define a cover. By way of example, the plurality of adjacently disposed segments  17 ′ comprising a substantially triangular shape may comprise four segments, e.g.,  FIG. 16D , six segments, e.g.,  FIG. 16G , eight segments, e.g.,  FIGS. 16A, 16B, 16C, 16E and 16H , or even more than eight segments. Furthermore, as shown in  FIG. 16H , the plurality of adjacently disposed segments  17 ′ may comprise reinforcement ribs. Also, the illustrative embodiments of  FIGS. 16D-16E and 16G  may comprise a top flush relief ring, or a recessed pocket as is shown in  FIGS. 16C-16H . As shown in  FIGS. 16A-16B , other possible configurations of the plurality of adjacently disposed segments comprises a top flush configuration without a relief ring. 
     As is perhaps best shown in  FIGS. 5-6 , and as mentioned below, the inventive vacuum shield assembly  10  comprises a retaining assembly  20 . As shown in  FIGS. 1 and 6 , the retaining assembly  20  may be oriented towards the face of a patient, such that it may be used to attach the shield body  11  to an existing vacuum tube or other related component. Various connecting mechanism of the retaining assembly  20  may be implemented to connect it to the shield body  11 , vacuum tube, oxygen supply tube or nebulizing unit. Said differently, the retaining assembly  20  may be used to interconnect the shield body  11  to the vacuum tube and the oxygen supply tube, an existing nebulizing unit and/or mask, or an existing BIPAP or CPAP mask. As an example, the retaining assembly  20  may comprise clamps or connecting arms. Other mechanisms of the retaining assembly  20  are also within the scope of the present invention and may comprise adhesives, connecting bands, snap-on mechanisms, magnets, or another related connecting mechanisms. 
     As seen in the illustrative embodiments of  FIGS. 5 and 11 , the retaining assembly  20  may comprise a retaining frame  23  connected to a retaining component  21 . As mentioned above, a connecting portion  18  of the vacuum shield assembly  10  may be configured and dimensioned to correspond to the size of a retaining component  21  of the retaining assembly  20 . As may be appreciated from  FIG. 11 , sometimes it may be beneficial to provide for a height adjustment for the point of connection between the connecting portion  18  of the shield body  11  and the retaining assembly  20 . In such embodiments, the retaining component  21  may be provided with an upper section  21 ″, which may at least partially raise the position of the shield body  11  relative to the point of attachment of the retaining assembly  20  to the oxygen supply tube or other related component of the existing mask. 
     Additional features of the present invention comprise providing a shield body  11  that may be configured and dimensioned to correspond to the geometry and/or size of the head and/or face of patient and/or the existing mask and its components. It is within the scope of the present invention that when the shield body  11  is disposed against the existing mask that a substantial portion of the edge  12  at least partially surround the existing mask. That is, the shield body  11 , including the edge  12  of the perimeter, should define a profile or area that is at least equal to or even greater than the profile or area of the existing mask. As such, exhaled air from the patient will be retained on an inside of the shield body  11 , including above a lower segment  15 . As an example, as is shown at least in  FIGS. 4 and 9-10 , the edge  12  may comprise a semi-ovoidal configuration. As is perhaps best shown in  FIGS. 4 and 9 , the edge  12  may also define a substantially flat side profile of the shield body  11 . However, the shield body  11  may comprise other shapes to correspond to the shape of the existing mask. The lower segment  15  may be configured and dimensioned to accommodate the size and/or geometry of an oxygen supply tube of a BIPAP or CPAP mask, or the size and/or geometry of a nebulizer unit and/or components thereof. 
     The illustrative embodiment of  FIGS. 6-9 and 11  show a retaining assembly  20  comprising a retaining component  21  and an upper section  21 ″ thereof which provides for a vertical offset. The length of the upper section  21 ″ may be configured and dimension according to preferences, type of existing mask, intended application, amount of height adjustment needed for the shield body  11 , etc. These illustrative embodiments, both of the retaining component  21  and the upper section  21 ″ comprise a substantially cylindrical configuration with approximately the same diameter. Conversely, as is in the illustrative embodiments of  FIGS. 1-5 , the retaining assembly  20  may be provided with a retaining 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  be attachable to the retaining component  21  and/or upper section  21 ″ thereof. For example, the connecting component  18  may comprise a substantially cylindrical configuration, which may be configured and dimensioned to correspond to the size of an inside of a cylindrical retaining component  21  and/or upper section  21 ″. Further to this example, and as is perhaps best shown in  FIGS. 4 and 9 , the outer diameter of the connecting 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 connecting component  18  may be inserted into the retaining component  21  and/or upper section  21 ″. In at least one embodiment the retaining component  21  and upper section  21 ″ may comprise the same diameter. Additionally, in such embodiments, both diameters of the connecting component  18 , retaining component  21  and/or upper section  21 ″ may be configured and dimensioned to enable a frictional resistance between corresponding surfaces such that the shield body  11  may be connected to the retaining assembly  20 , and further, so that it may remain in place during periods of operation or use of the inventive vacuum shield assembly  10 . 
     As may be perhaps best shown in the illustrative embodiments of  FIGS. 2-5 and 7-11 , the retaining component  21  of the retaining assembly  20  comprises a lower section  21 ′. The inside of the lower section  21 ′ of the retaining component  21  should be disposed in fluid communication with the inside of the retaining component  21 , the inside of the connecting portion  18  of the shield body  11 , the inside of the upper section  21 ″ of the retaining component, and/or the inside of the vacuum tube. Additionally, the lower section  21 ′ of the retaining component  21  may be configured and dimensioned for attachment of the vacuum tube. By way of example only, the lower section  21 ′ of the retaining component  21  may be provided with an outer diameter that is at least partially smaller to an inner diameter of the vacuum tube. As such, the vacuum tube may be attached to the outside of the lower section  21 ′ of the retaining component  21 , and may be disposed in fluid communication with an inside of the lower section  21 ′ of the retaining component  21 , the inside of the retaining component  21 , an inside of the upper section  21 ″ of the retaining component  21 , and/or an inside of the connecting portion  18 . This should enable a fluid communication between the vacuum tube and the shield body  11 , including on an interior or inside thereof, which is perhaps best shown in  FIG. 10 . As such, activation of the vacuum tube will result in a negative pressure around the inside of the shield body  11 . Such a negative pressure will result in at least a partial removal of the air on the inside of the shield body  11  and/or the surrounding area. 
     With reference to at least  FIGS. 5 and 11 , and as mentioned above, the retaining assembly  20  may be provided with a retaining frame  23 . The retaining frame  23  may be connected to the retaining component  21 , for example, via a transition structure  22 . The retaining frame  23  is intended to attach the retaining assembly  20 , and consequently the shield body  11  and vacuum tube, to a component of the existing mask. For example, such a component of the existing mask may include an oxygen supply tube of a BIPAP of CPAP mask. Also as an example, such a component of the existing mask may also include a nebulizing unit or a portion or component thereof. The retaining frame  23  should comprise an inner area, which may be selectively adjusted to securely retain the oxygen supply tube or nebulizing unit or component thereof. For example, the retaining frame  23  may comprise a substantially cylindrical configuration and/or two segments which may be connected to one another. A first closing structure  25  and a second closing structure  26  may be provided and may be cooperatively configured to form a closing mechanism or engagement that retains the oxygen supply tube or nebulizing unit. Also as an example, the first closing structure  25  and/or second closing structures  26  may be provided with a closing mechanism or related components that may enable such closing mechanism or engagement. 
     In the illustrative embodiments of  FIGS. 1-11 , a first closing structure  25  may be provided with a snap component whereas a second closing structure  26  may be provided with serrations  25 ′. The snap component and the serrations  25 ′ may be cooperatively configured with one another to form a mating engagement, and allow a user or medical practitioner to selectively increase or decrease the inner area of the retaining frame  23 . For example, the snap may be selectively disposed in any one of a plurality of serrations  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 multi-snap mechanism, i.e., an adjustable mechanism that may be selectively disposed into various size settings. As such, one single retaining assembly  20  may be used in connection with various oxygen supply tubs of different sizes and/or nebulizer units of different sizes. To further assist the user or medical practitioner in adjusting the inner area or opening of the retaining frame  23 , one or more flaps  24  and/or  24 ′ may be provided. The flaps  24  and/or  24 ′ may be disposed or otherwise formed on the segments of the retaining frame  23 , including around the first closing structure  25  and/or second closing structure  25 . The flaps  24  and/or  24 ′ may extend along the height of the retaining frame  23  and/or may comprise a size that corresponds to the size of the thumbs and/or fingers of a user or medical practitioner. Thus, selective movement of the flaps  24  and/or  24  will result in a corresponding movement of at least one of the segments of the retaining frame  23 , and consequently movement of a corresponding closing structure  25  and/or  26 . Although a retaining assembly  20  may be provided comprising two flaps  24  and  24 ′, it is also possible to provide a retaining assembly  20  comprising only one flap  24  or one without any flaps. 
     As is perhaps best show in in  FIG. 5 , the retaining frame  23  may be provided with at least one retaining segment  28  configured to at least partially retain the nebulizing unit. For example, as shown in the illustrative embodiment of  FIG. 3 , two retaining segments  28  may be used to at least partially retain a middle section of a nebulizing unit. Further, each retaining segment(s)  28  may comprise latch  29  disposed around an upper end thereof. The latch(es)  29  may be configured to hold the top of the middle section of the nebulizing unit in place and at least partially reduce its movement in the vertical direction. As is also shown in the illustrative embodiment of  FIG. 3 , and also in other embodiments, the retaining frame  23  may be provided with a substantially cylindrical or semi-cylindrical configuration. Such configuration is advantageous to retain or otherwise attach the retaining assembly  20  to substantially cylindrical nebulizers or oxygen supply tubes. 
     With reference now to at least  FIGS. 1-3 and 6-8 , features of the present invention comprise providing a vacuum shield assembly  10  with a shield body  11  and a retaining assembly  20  collectively disposable into and out of an operative position and an inoperative position. As used herein, the “inoperative position” refers to a position of non-use of the vacuum shield assembly  10 , and may include a storage position, an inactive position, a position where the vacuum shield assembly is not connected to external components, e.g., an oxygen supply tube, vacuum tube, nebulizer unit, face or head of a patient, etc. Conversely, as used herein, the “operative position” refers to an operational or otherwise active positon of the vacuum shield assembly  10 . In the operative position, the shield body  11  should be connected to and disposed in fluid communication with the retaining assembly  20 . As is shown at least in  FIGS. 1-3 and 6-8 , in the operative position, an interior or inside of the shield body  11  should be oriented toward the existing mask, which should already be disposed on the face and/or head of the patient. In the operative position, the vacuum tube, and/or connected vacuum source, should exert a negative pressure, which should result on a corresponding exerted negative pressure around the shield body  11  and the surrounding area. It is contemplated that in the operative position, the negative pressure exerted 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 the exhaled air form the patient. Also, the lower segment  15 , along with the interior or inside of the shield body  11 , is intended to at least partially retain exhaled air between the face of the patient and/or existing mask, and the shield body  11 . As such, movement of the exhaled patient air outside of the area surrounding the shield body  11  may be at least partially reduced, such that, the negative pressure of the vacuum tube, should result on an efficient removal of the exhaled air. 
     With reference to  FIGS. 17-19D , further embodiments of the present invention relate 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 wearing a medical mask as defined herein, but may also be used on patients not wearing a medical mask as the various components of the system  1 ′ may be at least partially disposed on the patient directly. With specific reference to at least  FIGS. 17 and 18 , the system  1 ′ generally comprises at least a vacuum shield assembly  10  as defined herein, a retaining assembly  20  as defined herein, a vacuum tube  40  and a vacuum unit  80 . In embodiments of the present invention where the shield body  11  may be disposed directly on a patient not wearing a medical mask, a retaining assembly  20  may not be necessary as the vacuum tube  40  may be disposed directly on the shield body  11 . As used herein, a vacuum unit  80  refers to a vacuum device, which may be motor operated, and which may be disposed in fluid communication with a vacuum tube  40 , i.e., a hose, or other flexible or expandable hollow elongated component, and which may exert a negative pressure. It is contemplated that a shield body  11  of the shield assembly  10  also be disposed in fluid communication with the interior of the vacuum tube  40 . The negative pressure of the vacuum unit  80  should be transferred through the vacuum tube  40 , and to an interior face of the shield body  11 , i.e., the side that faces the patient. As such, the shield body  11  essentially acts as a vacuuming device that is capable of at least partially removing exhaled air around the face of the patient. As used herein, the space defined by the interior face of the shield body  11  as well as the face of the patient, including when wearing the medical mask, is defined as an enclosure zone  19 . 
     With reference to at least  FIG. 18A , the system  1 ′ according to the present invention may comprise a retaining assembly  20  configured to retain the vacuum tube  40  and a component of the medical mask as defined herein, i.e., an oxygen supply tube of a BIPAP of CPAP mask or a nebulizing unit or a portion or component thereof. Further, the vacuum tube  40  may comprise a body  41  of a flexible, or elastic material that may at least partially bend, twist, move or otherwise conform to geometric constraints. The vacuum tube  40  may comprise a proximal end  44  that connects to the vacuum unit  80  around connecting end  36 , and a distal end  42  that connects to the shield body  11  around a connecting end  46 . 
     With reference to at least  FIGS. 18A-18B , a filter case assembly  50  may be disposed or integrally formed on the vacuum tube  40  around the proximal end  44 . The filter case assembly  50  may comprise a top segment  52  and a bottom segment  54  which may be operatively connected to one another. In other words, the top segment  52  and bottom segment  54  may form a mating engagement with one another in a secured position, i.e., once a filter  70  has been placed between them. It is contemplated that the mating engagement between top segment  52  and bottom segment  54  not be a permanent mating engagement such that the top segment  52  and bottom segment  54  may be removably connected to one another to insert and/or remove a filter in the area where they engage. The diameters of the top segment  52  and/or bottom segment  54  should correspond to one another and should be configured and dimensioned to accommodate the diameter and/or size of a filter  70 , which may comprise an air filter such as an ultra-low particulate air (ULPA) filter. The filter  70  may also comprise a high efficiency particulate air (HEPA) filter. As such, the diameters of the top segment  52  and/or bottom segment  54  may be larger than the diameter of the vacuum tube  40 , but this is not strictly necessary. When the top segment  52  and the bottom segment  54  are forming a mating engaged, this should restrict placement or otherwise movement of a filter  70  disposed therein. Furthermore, the top segment  52  and/or upper segment  54  may be provided with conical or semi-conical shapes. This may be done to at least partially facilitate airflow through the vacuum tube  40  and into the vacuum unit  80  and/or to otherwise at least partially reduce the likelihood of a bottleneck effect around the area where the filter  70  is disposed. Consequently, air captured around a distal end  42  of the vacuum tube will pass through the filter  70  before entering the vacuum unit  80 , at least partially reducing contaminants and/or other infectious particles. 
     With reference to at least  FIGS. 17 and 18B , and as mentioned above, the system  1 ′ according to the present invention comprises a vacuum unit  80 . The vacuum unit  80  should provide for a portable solution of creating a negative vacuum pressure, at least around its first opening  84  where the vacuum tube  40  will be connected. The vacuum unit  80  may comprise a housing  82  with a first opening  84  and a second opening  86 . The first opening  84  is generally configured for attachment of the vacuum tube  40 , for example, around a proximal end  44  thereof. The second opening  86  is generally configured for captured air to exit outside of the housing  82 . That is, air collected form the enclosure zone  19  that passes through the first opening  84  and into the interior of the housing  82 , should be able to exit outside of the housing  82  through the second opening  86 . Alternatively, other means of air escape may be provided on the housing, and may include slots or vents, including disposed on the sides. In addition, the interior of the housing  82 , which is generally a chamber, may be provided with other filtering means to further remove contaminants and/or infections particles form the air captured around the enclosure zone  19 . Also, a top cover of the housing may be removable from the rest of the housing  82  to access any components thereof, which may include a battery-operated vacuum with a motor, additional filtering components, etc. By way of example only, a battery-operated vacuum motor of 110V or similar, may be provided on an inside of the housing  82 . 
     Specific to the system  1 ′ according to the present invention, the vacuum unit  80 , vacuum tube  40  and shield body  11  may be collectively disposable into and out of an operative orientation and an inoperative orientation. The operative orientation comprises the vacuum unit  80  activated and exerting a negative pressure on an inside of the shield body  11 , i.e., around the enclosure zone  19 , to at least partially remove exhaled patient air. The inoperative operation comprises periods of non-operation of the system  1 ′, including when the vacuum unit  80  is inactive. Also, the shield body  11 , the vacuum tube  40  and the retaining assembly  20  may be collectively disposed into and out of an operative position and an inoperative position. With reference to  FIG. 18B , the operative position generally comprises the shield body  11  at least partially attached to the head of the patient and the vacuum tube  40  operatively connected to the shield body  11 . The operative position may also comprise the vacuum tube  40  and the component of the medical mask disposed onto the retaining assembly  20 . The operative orientation may also comprise disposing the shield body  11 , the vacuum tube  40  and the retaining assembly  20  into the operative position and the vacuum unit  80  being activated to exert a negative pressure on the inside of the vacuum tube  40  as well as the interior of the shield body  11 , at least partially removing exhaled air from the patient around the enclosure zone  19 . In at least one embodiment of the system  1 ′ according to the present invention, the system  1 ′ is capable of removing at least 93% of exhaled particles having a size of 0.5 micron. In order to achieve this, the system  1 ′ should be capable of delivering a negative pressure of at least 240 liters per minute, measured around the interior of the shield body  11 , and in some embodiments up to about 280 liters per minute. In turn, this at least partially achieves a re-breathing or re-inhalation reduction of up to about 6%, while at the same, given the geometry of the components of the shield body  11 , does not substantially reduce the amount of inhaled oxygen, i.e., from an oxygen supply tube, or nebulizer particles. In some embodiments the amount of nebulizer particles provided to the patient is maintained, and in other embodiments, even increased. 
     With reference now to at least  FIGS. 19A-21D , and as mentioned above, various components of the innovative system  1 ′ may be disposed into an operative position as shown in  FIGS. 19D, 20D and 21D . The shield body  11  may be connected to the retaining assembly ( FIGS. 19A and 20A ). Thereafter, the retaining assembly  20  may be connected to an oxygen supply tube of an existing mask ( FIG. 20B ), or to a nebulizer ( FIG. 19B ). Thereafter, the vacuum tube  40  may be connected to the retaining assembly  20  ( FIGS. 19C and 20C ). In some embodiments where a medical mask or existing mask is provided with an adjustable strap. The strap may be inserted between the outer surface of the mask and a retaining component ( FIG. 21A ) and one of a plurality of adjustable holes of the strap may be inserted into a retaining element to adjust the length of the strap ( FIG. 21B ). The remaining portion of the strap may be secured the side structures of the retaining component ( FIG. 21C ). 
     With reference now to at least  FIG. 22 , the present invention is also directed towards a method  200  of removing exhaled air from a patient. As shown at  210 , the method  200  comprises providing (i) providing a system  1 ′ as defined herein configured to remove exhaled air from the patient wearing the medical mask. The system  1 ′ may comprise: a vacuum unit  80 , a vacuum tube  40 ; an air filter  70  operatively disposed on an inside of the vacuum tube  40 ; a vacuum shield assembly  10  comprising a shield body  11  that is disposable onto the patient wearing the medical mask; and a retaining assembly  20  structured to retain the vacuum tube and a component of the medical mask; wherein the vacuum tube  40  is disposed in fluid communication with an inside of the shield body  11  and the vacuum unit  80 , and wherein the vacuum tube  40 , the shield body  11  and the vacuum unit  80  are collectively disposable into and out of an operative orientation and an inoperative orientation. The method  200  may further comprise: (ii) disposing the shield body  11  onto the retaining assembly  20 , which is shown at  220 ; (iii) disposing the component of the medical mask onto the retaining assembly  200 , which is shown at  230 ; (iv) disposing the vacuum tube  40  in fluid communication with an inside of the shield body  11 , which is shown at  240 ; (v) at least partially disposing the medical mask on the head of the patient, which is shown at  250 , and (vi) at least partially disposing the shield body  11  around the medical mask, which is shown at  260 . The method  200  may further comprise at least partially disposing the shield body  11  around the medical mask comprises at least partially disposing the shield body  11  around the medical mask and in proximity to the face of the patient creating an enclosure zone  19 . As shown at  270 , the method  200  may further comprise (vii) disposing the vacuum tube in fluid communication with an inside of the vacuum unit, and as shown at  280  (viii) activating the vacuum unit to exert a negative pressure on the enclosure zone and remove exhaled air from the patient. The method  200  may further comprise (viii) activating the vacuum unit  80  to exert a negative pressure on the inside of the vacuum tube  40  and on the inside of the shield body  11  to remove exhaled air from the patient between the inside of the shield body  11  and the face of the patient. 
     Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.