TONGUE DEPRESSOR AND ORAL/NASAL SWAB MOUNTED SHIELD, METHOD OF USE, AND METHOD OF MANUFACTURE

Abstract

A PPE shield mounted on a tongue deflector (depressor) or an oral/nasal swab establishes a barrier between the patient and a healthcare provider to substantially block aerosols and the like which may be exhaled or expelled by the patient, thereby protecting the healthcare provider from exposure to these aerosols and the like while performing a procedure. The shield may be generally concave, such as frustroconical or hemispherical. The depressor or swab may be inserted through an opening in the shield. A support structure may be formed at or around the opening. A flat view port may be provided in the shield, allowing the healthcare provider to have an unobstructed and undistorted view of the patient's oral cavity or nasal passage while performing the procedure. The shield may be vacuum formed.

Claims

1. A PPE shield for use by a healthcare provider when performing an oral or nasal procedure on a patient, said shield comprising: a sheet of plastic material; an opening in the plastic material; and a support element surrounding the opening and extending from at least one of the inner or outer surfaces of the shield.

2. The PPE shield of claim 1, wherein: the sheet of material is concave, to conform to the generally convex shape of the patient's face.

3. The PPE shield of claim 1, wherein: the sheet of material is in the shape of a truncated cone (frustrum) or hemispherical.

4. The PPE shield of claim 1, wherein: the plastic material is substantially transparent.

5. The PPE shield of claim 1, wherein: the plastic material comprises PET (polyethylene terephthalate).

6. The PPE shield of claim 1, wherein: the shield is sufficiently rigid to not deform when slight forces are applied thereto, such as when inserting a tongue depressor or nasal swab through the opening, and subsequently manipulating the depressor or swab.

7. The PPE shield of claim 1, wherein: the shield is sized and shaped to fit over (in front of) the mouth of a patient, including the patient's jaw.

8. The PPE shield of claim 1, wherein: the shield is sized and shaped to fit over (in front of) the lower facial area of a patient, including patient's mouth and optionally the patient's nose.

9. The PPE shield of claim 1, wherein: in use, when the shield placed onto (in front of) the patient's face, the shield establishes a barrier between the patient and a healthcare provider to substantially block aerosols and the like which may be exhaled or expelled by the patient, thereby protecting the healthcare provider from exposure to these aerosols and the like.

10. The PPE shield of claim 1, wherein: the opening is in the form of a slot or slit which is sized to receive a tongue depressor or nasal swab with a slight interference fit which allows the tongue depressor or nasal swab to be inserted through the shield, resulting in the shield being supported on the tongue depressor or nasal swab during performing the oral or nasal procedure, respectively.

11. The PPE shield of claim 1, further comprising: a support structure disposed at or around the opening to provide stability to a tongue depressor or nasal swab inserted through the opening.

12. The PPE shield of claim 1, wherein: the support structure is formed integrally with the shield, and extends either internally (in use, towards the patient) or externally (in use, towards the healthcare provider) from a respective inner or outer surface of the shield.

13. The PPE shield of claim 11, wherein: the support structure is in the form of a tubular extension of the opening.

14. The PPE shield of claim 1, wherein: a portion of the shield is substantially flat, providing a view port allowing the healthcare provider to have an unobstructed and undistorted view of the patient's oral cavity or nasal passage while performing the procedure.

15. The PPE shield of claim 14, wherein: the opening is disposed on the view port.

16. The PPE shield of claim 14, wherein: the opening is disposed offset from a center of the view port.

17. The PPE shield of claim 1, wherein: the opening is disposed offset from a center of the overall shield.

18. Method of performing an oral or nasal procedure on a patient, comprising: providing a shield as described in claim 1; inserting a tongue depressor or swab through the opening of the shield; and performing the procedure.

19. Method of manufacturing a PPE shield, comprising: vacuum forming the shield of claim 1, including a protruding portion of the shield which forms a support structure; and then cutting or slitting the protruding portion of the shield which forms the support structure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Reference will be made in detail to embodiments of the disclosure, non-limiting examples of which may be illustrated in the accompanying drawing figures (FIGS.). The figures may generally be in the form of diagrams. Some elements in the figures may be stylized, simplified or exaggerated, others may be omitted, for illustrative clarity.

[0049] Although the invention is generally described in the context of various exemplary embodiments, it should be understood that it is not intended to limit the invention to these particular embodiments, and individual features of various embodiments may be combined with one another. Any text (legends, notes, reference numerals and the like) appearing on the drawings are incorporated by reference herein.

[0050] FIG. 1 is a diagram (perspective view) of a tongue deflector version of a shield with an external support feature disposed off-center on the view port, according to an embodiment of the invention.

[0051] FIG. 2 is a diagram (perspective view) of a swab version of a shield with an external support feature disposed off-center on the view port, according to an embodiment of the invention.

[0052] Some additional figures (and text) are presented in the APPENDIX, and are incorporated by reference herein.

DESCRIPTION

[0053] Various embodiments (or examples) may be described to illustrate teachings of the invention(s), and should be construed as illustrative rather than limiting. It should be understood that it is not intended to limit the invention(s) to these particular embodiments. It should be understood that some individual features of various embodiments may be combined in different ways than shown, with one another. Reference herein to “one embodiment”, “an embodiment”, or similar formulations, may mean that a particular feature, structure, operation, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Some embodiments may not be explicitly designated as such (“an embodiment”).

[0054] The invention disclosed herein is generally a shield, which may be referred to as a “PPE shield” which is intended to be mounted on a tongue depressor or oral/nasal swab, so as to provide a barrier between healthcare provider and patient.

[0055] Patients have the tendency to cough and sneeze when probed with a Tongue Depressor and Oral/Nasal Swab. Coughing and sneezing projectiles patient aerosol out of the oral and/or nasal cavity and onto the healthcare provider. Some of the aerosol is in fine particles which are suspended in the air but most of the aerosol is in larger particles which are carried through the air to settle wherever they impact on the healthcare provider and surroundings. This requires the healthcare provider to wear PPE and substantial disinfection of the environment post procedure.

[0056] The innovation disclosed herein is a “shield” that provides a simple and low-cost PPE solution to capturing the larger aerosol particles thereby providing additional protection to healthcare providers.

[0057] The shield mounts onto Tongue Depressor or Oral/Nasal Swab and provides a clear view of the patient's anatomy (mouth or nasal cavity) so the procedure can be performed as usual.

[0058] During performing the procedure, the shield, with tongue depressor or swab mounted therein, is positioned by the healthcare provider in front of the patient's mouth and nose to block aerosol discharge so that it does not transfer to the healthcare provider.

[0059] Because cost is always a consideration with PPEs as single use devices, it is imperative to implement a low cost material and fabrication technology.

[0060] The shield may readily be manufactured utilizing vacuum forming technology such as is used to manufacture single use cup lids and disposable food packages.

[0061] The shield may be formed of thin, inexpensive material (such as, but not limited to PET) that may quickly and easily be formed to shape. The material may also be available in clear transparent materials.

[0062] FIG. 1 is a diagram (perspective view) of a tongue deflector version of a shield with an external support feature disposed off-center on the view port, according to an embodiment of the invention. This figure demonstrates the shield acting as a barrier between the healthcare provider side of the tongue deflector and the patient's oral and nasal cavities.

[0063] FIG. 2 is a diagram (perspective view) of a swab version of a shield with an external support feature disposed off-center on the view port, according to an embodiment of the invention. This figure demonstrates the shield acting as a barrier between the healthcare provider side of the swab and the patient's oral and nasal cavities.

APPENDIX

[0064] Appended hereto and forming part of the disclosure hereof is an 18 page document entitled “Tongue Deflector Shield”. The Appendix describes the innovation process as an Engineering Notebook would, in chronological order. Therefore, the embodiments disclosed in the last few pages of the Appendix may be preferred. As disclosed therein:

[0065] Page 1 shows a perspective view (left) and a side view (right) of a simple shield with a tongue depressor inserted therethrough.

[0066] Page 2 shows that the shield may not be well supported on the tongue depressor due to the very limited area of contact between the tongue depressor and the shield.

[0067] Page 3 shows that a support feature may be incorporated into (integrally formed with) the shield to provide stability to the shield when mounted on a tongue depressor. The tongue depressor extends through an orifice (opening, slit or slot) in the shield. The support feature is generally a tubular extension of the shield, extending from the orifice, and provides additional support and stability for the tongue depressor mounted shield.

[0068] As shown in the upper figure, the support feature may extend towards the outside of the shield (towards the healthcare provider).

[0069] As shown in the lower figure, the support feature may extend towards the inside of the shield (towards the patient).

[0070] The support feature is sized and shaped to securely retain the shield on the tongue depressor.

[0071] Page 4 shows the shield mounted on a tongue depressor in use with a patient. The two figures illustrate that a portion of the shield may be formed as a flat view port or window to provide the healthcare provider with an undistorted view of the patient's anatomy.

[0072] Page 5 shows in greater detail (three views) the shield with the support feature extending internally from the shield, towards the patient. The support feature for a tongue depressor may be a flat, tubular element, extending a few millimeters from the internal surface of the shield.

[0073] Page 6 shows (three views) that a portion of the shield may be flat, providing a view port.

[0074] The figure on the right shows that stiffening features (ribs) may be incorporated into the surface of the shield to make an otherwise flexible shield stiffer, without increasing material thickness.

[0075] The figure on the right also shows that there is a friction fit between the tongue depressor and shield which is sufficient to prevent the shield from sliding off of the tongue depressor, during use.

[0076] Page 7 shows a prototype vacuum forming mold used to produce an embodiment of the shield for use with tongue depressors.

[0077] In this embodiment, the support feature extends towards the interior of the shield. A flat area for the view port is evident.

[0078] Channels for forming the stiffening features (ribs) are visible on the mold.

[0079] Page 8 shows (four views) a closeup or the fabrication steps, for an embodiment with the support feature (or simply “feature”) extending inwardly (patient side) from the shield. [0080] Step 1: the support feature, projecting from the inner surface of the shield, is vacuum formed [0081] Step 2: the tip (inner end) of the feature is excised, cut-off, removed [0082] Step 3: the feature is now clear (open) so that the tongue deflector can be inserted therethrough [0083] Step 4: the tongue deflector is inserted through the feature, either from the inside or the outside

[0084] Page 9 shows (four views) a closeup or the fabrication steps, for an embodiment with the support feature (or simply “feature”) extending inwardly (patient side) from the shield. [0085] Step 1: the support feature, projecting from the inner surface of the shield, is vacuum formed [0086] Step 2: a slit is formed in the tip (inner end) of the feature [0087] Step 3: the feature is ready to accept the tongue deflector (or may be further cut for easier insertion of the tongue deflector.) [0088] Step 4: the tongue deflector is inserted through the feature, either from the inside or the outside Note: In this embodiment, no material need be removed (contrast the embodiment on Page 8)

[0089] Page 10 shows (two views) of the tongue deflector with internal retaining/support feature disposed off-center in the flat viewing area (view port) to allow better visibility of the area being treated (such as the patient's oral cavity) [0090] note: the left illustration corresponds with FIG. 1. The internally-extending feature is not very visible in this view. See detail of internally-extending feature on Pages 8, 9.

[0091] Page 11 shows (two views) of an embodiment similar to the embodiment shown on Page 10, but with the retaining/support feature extending external from the flat area (view port) of the shield. The external feature is shown off-center similar to the Page 10 embodiment. [0092] note: The feature, whether internal or external, may be disposed on the shield at other than the flat view port area of the shield. [0093] note: The feature, whether internal or external, may extend only a few millimeters from the surface of the shield (or view port)

[0094] Page 12 shows (four views) a closeup or the fabrication steps, for an embodiment with the support feature (or simply “feature”) extending externally (caregiver side) from the shield. [0095] Step 1: the support feature, projecting from the inner surface of the shield, is vacuum formed [0096] Step 2: the tip (inner end) of the feature is excised, cut-off, removed [0097] Step 3: (internal view) the feature is now clear (open) so that the tongue deflector can be inserted therethrough [0098] Step 4: (external view) the tongue deflector is inserted through the feature, either from the inside or the outside

[0099] Page 13 shows (two views, plus detail) of an embodiment with the support feature extending externally from the shield. The closeup view shows the slit for receiving the tongue depressor (or deflector). [0100] note: in these figures, the shield is shown white, rather than transparent, for illustrative clarity

[0101] Page 14 shows (three views) of an embodiment with the support feature extending externally from the shield. The tongue depressor/deflector is shown extending through the support feature. [0102] note: in these figures, the shield is shown white, rather than transparent, for illustrative clarity [0103] note: In this embodiment, no material need be removed (contrast the embodiment on Page 12) [0104] NOTE: It may be observed, in several of the embodiments illustrated herein, that the shield is in the form of a truncated cone (or “frustrum”), with the view port at the top surface of the truncated cone. This has the advantage that the view port is on a flat surface. The side surfaces of the shield may be substantially straight, rather than curved in the semi-spherical versions of the shield.

[0105] Page 15 shows (two views) of an embodiment with the support feature extending externally from the shield. The tongue depressor/deflector is shown extending through the support feature. [0106] note: in these figures, the shield is shown white, rather than transparent, for illustrative clarity [0107] note: in the left hand figure, the stiffening ribs (or channels) in the shield are visible [0108] note: the closeup of the support feature shows the expansion (spreading) of the support feature over the tongue depressor to create an interference fit which provides stability to the shield and inhibits (or prevents) unintended sliding along the tongue depressor during the procedure.

[0109] Page 16 shows (one view) of a prototype vacuum forming mold used to produce an embodiment of the shield with a externally-extending support feature (for a tongue depressor).

[0110] Page 17 shows (two views) an embodiment of the shield intended for use with an oral/nasal swab. Compare FIG. 2.

[0111] This version is shown being used with a swab. The opening for the swab is disposed off center on the view port (top surface of the frustrum).

[0112] In the left hand view, the shield is oriented (with respect to the patient) so that the opening is disposed below the center of the shield (i.e., view port), to allow access to the patient's oral cavity and an unobstructed view of the oral cavity by the caregiver.

[0113] In the right hand view, the shield is oriented (with respect to the patient) so that the opening is disposed above the center of the shield (i.e., view port), to allow access to the patient's nasal cavity and an unobstructed view of the nasal cavity by the caregiver.

[0114] Page 18 shows (two views) an embodiment of the shield intended for use with an oral/nasal swab.

[0115] NOTE: Design considerations for the tongue deflector version of the shield are also applicable to the swab version of the shield, the main difference being in the form factor of the support element extending from the internal or external surface of the shield.

[0116] Regarding Internal v. External Feature From the vacuum forming process perspective, the external features are easier to achieve because the vacuum has more surface to act upon as the warm material is ‘lowered’ over the mold. That generates higher forces on the warm material which permits the fabrication of more intricate features (see Appendix; Page 16).

[0117] Internal features formation is limited by their surface area and therefore less force is available for their creation. Referring to Page 7 of the Appendix, as the warm material is ‘lowered’ over the mold, once the warm material makes contact with the flat surface the vacuum force is limited to the feature opening.

DISCLAIMER

[0118] It is important to note that while shields and covers can provide some protection from bodily fluids, they are not foolproof and healthcare providers should still take precautions to minimize their risk of exposure. This can include wearing gloves, masks, and eye protection, as well as following proper hand hygiene practices.

[0119] While the invention(s) may have been described with respect to a limited number of embodiments, these should not be construed as limitations on the scope of the invention(s), but rather as examples of some of the embodiments of the invention(s). Those skilled in the art may envision other possible variations, modifications, and implementations that are also within the scope of the invention(s), and claims, based on the disclosure(s) set forth herein.