A face mask

Abstract

A respiratory face mask comprising a medical instrument entry port (140) in which the medical instrument entry port (140) comprises a laminar medical instrument entry port (140) having an outer layer (180) defining a medical instrument receiving opening (190) and an inner valve (210,220,230) abutting the outer layer (180) and defining a valve (170) for preventing fluid escape through the medical instrument entry port (140).

Description

[0001] A FACE MASK

[0002] Field of Invention

[0003] This invention relates to a respiratory face mask comprising a medical instrument entry port for protecting the wearer and third parties from infection.

[0004] Background of the Invention

[0005] Respiratory face masks are a form of personal protective equipment (PPE) worn to protect the wearer from particulates and particularly in more recent times from infectious biological agents such as viruses, bacteria and the like. Similarly, face masks are often used to reduce the probability of the communication of biological agents from the mouth or nose of the wearer of the mask to third parties in proximity to the wearer of the mask. Face masks can have various configurations ranging from basic fabric coverings to more sophisticated configurations adapted to optimise the effectiveness of the face mask. Known examples include surgical masks, N95 respirators, KN95 respirators, bandana-type and pull-up face masks, cloth masks and FFP2 masks. However, such masks are not adapted for preventing communication of infection between a patient and a medical professional, and particularly from the patient to the medical professional during medical procedures being performed on the patient.

[0006] Preventing communication of infection between a patient and medical professionals is a known concern in medicine. More recently, COVID-19 has introduced particular challenges for medical professionals wishing to perform procedures on patients via the nose or mouth for diagnostic or treatment purposes. During such procedures, the patient must be unmasked to facilitate access to the nose or mouth which greatly increases the risk of infection transmission between the medical professional and the patient. Moreover, the use of endoscopic instruments in such procedures can result in the generation of aerosols which can greatly increase the risk of infection for medical professionals. In busy clinical settings such as outpatient departments and the like, the unmasking of the patient can also greatly increase the risk of infection for other patients attending the clinic.

[0007] Accordingly, various face masks have been developed which permit the insertion and removal of medical instruments to access the nose or mouth. For example, a SNAP (trade mark) valve is known which can be retrofitted to a face mask to allow insertion of a scope through the valve. US Patent Specification No. 2021 / 0345699 describes a mask provided with self-sealing ports and PCT Patent Specification No. 2021 / 237060 describes a medical mask provided with a hole and valve for receiving medical instruments. However, the known face masks suffer from poor visibility for the medical professional or fail to effectively prevent aerosol escape or both.

[0008] An object of the invention is to overcome at least some of the problems of the prior art.

[0009] Summary of the Invention

[0010] According to the invention there is provided respiratory face mask comprising: a face covering for covering a nose and mouth of a patient, and a medical instrument entry port on the face covering comprising an outer layer defining a medical instrument receiving opening and a valve at an inner face of the outer layer for preventing fluid escape through the medical instrument receiving opening wherein the valve comprises a generally conical sidewall defining a medical instrument receiving aperture at the medical instrument receiving opening; an opposite medical instrument exit movable between a fluid tight open and a fluid tight closed position, and a guide lumen extending between the medical instrument receiving aperture and the medical instrument exit.

[0011] In any embodiment, the medical instrument exit is formed at an apical tip of the conical sidewall . In any embodiment, the medical instrument exit comprises a slit extending from the apical tip towards the medical instrument receiving aperture to define a sealing flap.

[0012] In any embodiment, the medical instrument exit comprises at least two circumferentially spaced slits extending from the apical tip to define two sealing flaps.

[0013] In any embodiment, the medical instrument exit comprises four circumferentially spaced slits extending from the apical tip to define four sealing flaps.

[0014] In any embodiment, the conical sidewall comprises a first wall layer and a second wall layer abutting the first wall layer in a laminar fashion.

[0015] In any embodiment, the first wall layer and / or the second wall layer have a tapered thickness towards the apical tip.

[0016] In any embodiment, the first wall layer comprises at least one slit extending from the apical tip to define a sealing flap and the second wall layer comprises at least one slit extending from the apical tip to define a sealing flap, the slits being circumferentially offset to circumferentially offset the sealing flaps.

[0017] In any embodiment, slits in the first wall layer are circumferentially offset by up to about 90° with respect to slits in the second wall layer.

[0018] In any embodiment, the face covering comprises a clear panel for viewing a patient’s nose or mouth and the medical instrument entry port is provided on the clear panel.

[0019] In any embodiment, the clear panel comprises a mouth medical instrument entry port located at a mouth region of the clear panel.

[0020] In any embodiment, the clear panel comprises a nose medical instrument entry port located at a nose region of the clear panel. In any embodiment, the clear panel forms the outer layer of the medical instrument entry port.

[0021] In any embodiment, the conical sidewall is contiguous with the outer layer.

[0022] In any embodiment, the medical instrument receiving opening is circular in shape.

[0023] In any embodiment, the respiratory face mask further comprises an elongate medical instrument entry port.

[0024] In any embodiment, the elongate medical instrument entry port is rectangular in shape.

[0025] In any embodiment, the elongate medical instrument entry port comprises an openable flap or door.

[0026] In any embodiment, the face covering comprises a breathable fabric.

[0027] In any embodiment, the face covering comprises an upper nose portion with a contoured outer edge configured to fit around a nose.

[0028] In any embodiment, the upper nose portion is formed from a foam.

[0029] In any embodiment, the upper nose portion further comprises a nose clip.

[0030] In any embodiment, the face mask is configured to receive a bit block.

[0031] The respiratory face mask of the invention allows clinicians to safely access the mouth and / or nose of a patient during clinical procedures. Instrument access is achieved via a conical one way valve at the medical instrument entry port which prevents the escape of potentially infectious aerosol or airborne pathogens from the face mask. Where the face mask has a clear panel, the clinician also has visibility of the mouth and nose. Minimal aerosol leakage also occurs from the perimeter of the contoured mask. The entry port or entry ports can be attached to the mask as a final manufacturing process step which will allow for product customisation to suit different requirements

[0032] Brief Description of the Drawings

[0033] The invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0034] Figure 1 is a front perspective view of a patient wearing a first embodiment of a respiratory face mask of the invention which is provided with a clear or transparent panel so that a medical professional can see the patient’s nose / nostrils and mouth and valved instrument entry ports to facilitate fluid tight entry and removal of medical instruments through the mask in which the entry valves are inwardly disposed conical one-way valves made up of two conical silicone wall layers provided with elongate openings or slits on each layer and offset to each other between layers;

[0035] Figure 2 is an enlarged front plan view of the instrument entry port of Figure 1 in the closed position with no medical instrument inserted through the entry port;

[0036] Figure 3 is a side view of the instrument entry port of Figure 2;

[0037] Figure 4 is a front plan view of the instrument entry port of Figure 1 with a medical instrument such as an endoscope inserted through the entry port;

[0038] Figure 5 is a side view of the entry port of Figure 4;

[0039] Figure 6 is a front perspective view of a patient wearing a second embodiment of a respiratory face mask of the invention similar to the first embodiment but in which the inner valves of the nose and mouth instrument entry ports are modified slightly to have wall layers provided with two oppositely slits instead of four slits and the respiratory face mask is also provided with an additional elongate, rectangular and slot-like medical instrument opening adjacent the mouth entry port for receiving medical instruments such as spatulas and the like;

[0040] Figure 7 is a front perspective view of a patient wearing a third embodiment of the respiratory face mask similar to the face mask of Figure 6 but in which the nose medical instrument entry port is absent;

[0041] Figure 8 is an enlarged front view of the mouth medical instrument entry port and elongate medical instrument entry port of Figure 7;

[0042] Figure 9 is an enlarged front plan view of the nose / mouth medical instrument entry port of Figures 6 and 7 in the closed position with no medical instrument inserted through the entry port;

[0043] Figure 10 is a side view of the medical instrument entry port of Figure 9;

[0044] Figure 11 is an exploded side view of the double side wall of the inner valve of the medical instrument entry port;

[0045] Figure 12 is a front plan view of the instrument entry port of Figures 6 and 7 with a medical instrument such as an endoscope inserted through the entry port;

[0046] Figure 13 is a side view of the entry port of Figure 12;

[0047] Figure 14 is a front view of a further embodiment of a respiratory face mask of the invention similar to the face mask of Figure 7 configured for nose and throat procedures in which the mouth medical instrument port is omitted and the rectangular and slot-like medical instrument port is located at the edge of the clear panel towards a user’s chin area;

[0048] Figure 15 is a side view of the respiratory face mask of Figure 14; Figure 16 is an enlarged front view of the rectangular and slot-like medical instrument port of the mask of Figure 15;

[0049] Figure 17 is a front view of a further embodiment of a respiratory face mask of the invention similar to the mask of Figure 1 configured for gastrointestinal procedures in which the nose medical instrument entry port is omitted and the mask is provided with a large and a small mouth medical instrument entry port for receiving two differently sized medical instruments as required;

[0050] Figure 18 is a side view of the respiratory face mask of Figure 17,

[0051] Figure 19 is a front view of a further embodiment of the respiratory face mask of the invention similar to the face mask of Figure 17 but in which the mask is shaped and configured for use with a bite block to keep the patient's mouth open during a gastroscopy procedure.

[0052] Detailed Description of the Invention

[0053] Figures 1 to 5 show a respiratory face mask 10 of the invention for use by a patient 20. As shown in the drawings, the face mask 10 is generally made up of a face covering 30 for covering the nose 40 and mouth 50 of the patient 20 in which the face covering 30 is formed from a breathable fabric portion 60 and optionally has a clear panel 70 for viewing the patient’s nose 40 and mouth 50 as required. The face covering 30 is provided with oppositely disposed side straps 80 secured to the breathable fabric portion 60 by staples 90 such as steel staples 90 for attaching the face mask 10 to the patient’s ears.

[0054] The face covering 30 has an upper nose portion 100 provided with a contoured outer edge 110 to fit snugly around the nose 40. In the present embodiment, the upper nose portion 100 is formed from a foam such as a polyurethane nose foam 120. An aluminium nose clip 130 is also provided at the nose foam 120 to further ensure a tight fit of the face mask 10 about the nose 40. Importantly, the face covering 30 of the face mask 10 of the invention is provided with medical instrument entry ports 140 provided with a valve 170 for facilitating the fluid tight insertion and removal medical instruments 200 of varying diameters through the face mask thus allowing for the performance of medical procedures via or on the nose 40 and / or the mouth 50 of the patient 20. As the medical instrument 200 can be inserted through and removed from the face mask 10 in a fluid tight manner, aerosol escape from the patient 20 through the mask 10 is prevented and the risk of the transmission of an aerosol or airborne infection to the clinician and others is eliminated. Accordingly, the valved medical instrument entry ports 140 are configured to receive medical instruments 200 of varying diameters in a fluid tight manner.

[0055] In the present embodiment, the face mask 10 is provided with a mouth medical instrument entry port 150 located at a mouth region 31 of the face covering 30 and a nose medical instrument entry port 160 located at a nose region 32 of the face covering 30. More particularly, the mouth region 31 and nose region 32 of the face covering 30 are located on the clear panel 70 of the face covering 30 so that the clinician can see and manipulate the medical instrument 200 as required. The mouth and nose medical instrument entry ports 150,160 are identical in construction but can be sized as required e.g. in accordance with a size range of the medical instruments 200 to be used. In addition, the face mask 10 can be provided with either or both types of medical instrument entry ports 150,160 as desired.

[0056] As shown particularly in Figures 2 to 5, each medical instrument entry port 140 has an outer layer 180 defining a circular medical instrument opening 190 for receiving medical instruments 200 and an inner valve 170 bonded against the outer layer 180 at a bond 300 formed around the medical instrument opening 190. The inner valve 170 operates as a one-way valve 170 to prevent fluid escape from around medical instruments in use. The clear panel 70 of the face mask 10 of the present embodiment forms the outer layer 180.

[0057] In the present embodiment, the inner valve 170 is formed from a generally conical sidewall 172 which has an open medical instrument receiving aperture 171 at the medical instrument receiving opening 190 and a medical instrument exit 173 at its opposite end through which medical instruments 200 can pass through the medical instrument entry port 140 whilst the fluid-tightness of the medical instrument entry port 140 is maintained. This is achieved by the medical instrument exit 173 being movable between a fluid tight open and a fluid tight closed position. In the present embodiment, and as described in more detail below, the medical instrument exit 173 is formed at an apical tip 179 defined by the conical sidewall 172.

[0058] A guide lumen 178 for guiding a medical instrument 200 through the medical instrument entry port 240 to the medical instrument exit 173 is formed by the conical sidewall 172 and extends in a funnel-like configuration between the medical instrument receiving aperture 171 and the medical instrument exit 173. A laterally outward extending rim 174 is provided at the medical instrument receiving aperture 171 to form the bond 300. The bond 300 can be formed by silicone based adhesives and applied pressure at the rim 174.

[0059] In the present embodiment, the sidewall 172 is a double sidewall 172 formed from a first inner wall layer 220 and a second outer wall layer 230 which abuts the first wall layer 220 in a laminar fashion. However, it will be appreciated that in other embodiments of the invention, the sidewall 172 can be formed by a single wall layer 220 or more than two wall layers 220,230. The inner wall layer 220 can also be contiguous and integral with the outer layer 180 / clear panel 70.

[0060] The first wall layer 220 is provided with four slits 240 (each oppositely disposed slit being effectively contiguous this results in two perpendicularly arranged slits 240 when viewed from above), to form the medical instrument exit 173, which extend downwards from the apical tip 179 towards the medical instrument receiving aperture 171 but terminate short of the medical instrument receiving aperture 171 to define a sidewall unslit portion 175. The four slits 240 are configured to be circumferentially spaced about the first wall layer 220 of the sidewall 172 and together define the resilient openable and closable medical instrument exit 173 at the apical tip 179. Four resilient sealing flaps 252, which are generally triangular in shape, are therefore defined between the slits 240. Similarly, the second wall layer 230 is provided with slits 260 similar to the slits 240 of the first wall layer 220 to define a medical instrument exit 173 and, as before, triangular shaped sealing flaps 252 are therefore defined between the slits 260. The medical instrument exits 173 defined by the first and second wall layers 220,230 are aligned and contiguous. The slits 240,260 of each wall layer 220,230 are circumferentially offset typically by up to about 45° with respect to each other so that the sealing flaps 252 of the second valve layer 230 are also offset with respect to the sealing flaps 252 of the first valve layer 210 to ensure fluid tightness in use.

[0061] As will be appreciated by those skilled in the art, the slits 240,260 can be formed as required e.g. as preformed continuous slits or as perforations, weaknesses or scores to form a continuous slit upon medical instrument insertion and the term slit embraces all such configurations. In addition, as discussed in more detail below in relation to Figures 6 to 13, the number, shape and spacing of the slits 240,260 can be varied as required e.g. 1 , 2, 3, 4 or more slits 240,260 can be employed as required.

[0062] Figures 6 to 13 show second and third embodiments of the invention, broadly similar to the embodiment of Figures 1 to 5 in which the inner valves 170 of the nose and mouth instrument entry ports 150,160 are modified slightly. Like numerals indicate like parts.

[0063] As shown particularly in Figures 9 to 13, each medical instrument entry port 140 has an outer layer 180 defining a circular medical instrument opening 190 for receiving medical instruments 200 and an inner valve 170 bonded against the outer layer 180 at a bond 300 formed around the medical instrument opening 190. The inner valve 170 operates as a one-way valve 170 to prevent fluid escape from around medical instruments in use. The clear panel 70 of the face mask 10 of the present embodiment forms the outer layer 180.

[0064] In the present embodiments, the inner valve 170 is also formed from a generally conical sidewall 172 which has an open medical instrument receiving aperture 171 at the medical instrument receiving opening 190 and a medical instrument exit 173 at its opposite end through which medical instruments 200 can pass through the medical instrument entry port 140 whilst the fluid-tightness of the medical instrument entry port 140 is maintained. This is achieved by the medical instrument exit 173 being movable between a fluid tight open and a fluid tight closed position. In the present embodiment, and as described in more detail below, the medical instrument exit 173 is also formed at an apical tip 179 defined by the conical sidewall 172.

[0065] A guide lumen 178 for guiding a medical instrument 200 through the medical instrument entry port 140 to the medical instrument exit 173 is formed by the conical sidewall 172 and extends in a funnel-like configuration between the medical instrument receiving aperture 171 and the medical instrument exit 173. A laterally outward extending rim 174 is provided at the medical instrument receiving aperture 171 to form the bond 300. The bond 300 can be formed by silicone based adhesives and applied pressure at the rim 174.

[0066] In the present embodiment, the sidewall 172 is also a double sidewall 172 formed from a first inner wall layer 220 and a second outer wall layer 230 which abuts the first wall layer 220 in a laminar fashion. The inner wall layer 220 can also be contiguous and integral with the outer layer 180 / clear panel 70.

[0067] As shown particularly in Figures 10 and 11 , the first and second wall layers 220, 230 are both tapered with a decreasing thickness from the medical instrument receiving aperture 171 end to the apical tip 179. Accordingly, the conical double sidewall 172 is also tapered so that the base of the conical sidewall is relatively rigid at the medical instrument receiving aperture 171 and increasingly flexible towards the apical tip 179 and medical instrument exit 173.

[0068] In contrast with the embodiment of Figures 1 to 5, the first wall layer 220 is provided with two slits 240 either side of the apical tip 179 (each oppositely disposed slit 240 being effectively contiguous this results in one continuous slit 240 when viewed from above), to form the medical instrument exit 173, which extend downwards from the apical tip 179 towards the medical instrument receiving aperture 171 but terminate short of the medical instrument receiving aperture 171 to define a sidewall unslit portion 175. The two slits 240 are configured to be oppositely disposed spaced on the first wall layer 220 of the sidewall 172 and together define the resilient openable and closable medical instrument exit 173 at the apical tip 179. Two resilient sealing flaps 252, which are generally triangular in shape, are therefore defined between the slits 240.

[0069] Similarly, the second wall layer 230 is provided with slits 260 similar to the slits 240 of the first wall layer 220 to define a medical instrument exit 173 and, as before, triangular shaped sealing flaps 252 are therefore defined between the slits 260. The medical instrument exits 173 defined by the first and second wall layers 220,230 are aligned and contiguous. The slits 240,260 of each wall layer 220,230 are circumferentially offset typically by up to about 90° with respect to each other so that the sealing flaps 252 of the second valve layer 230 are also offset with respect to the sealing flaps 252 of the first valve layer 210 to ensure fluid tightness resulting from a petal formation in use.

[0070] In the present embodiment, as the number of sealing flaps 252 is reduced, it has been found that the fluid tightness of the inner seal 170 is increased together with the grip on medical instruments 200 in use.

[0071] As indicated above, the slits 240,260 can be dimensioned as required with a length of slit 240,250 to provide a medical instrument opening 190 having a maximum diameter of about 10mm for receiving endoscopes having a diameter of about 8mm and the like.

[0072] The embodiment of the invention shown in Figures 6 and 7 is also provided with an optional additional elongate, rectangular and slot-like medical instrument port 310 adjacent the mouth medical instrument entry port 150 for receiving elongate / flat medical instruments having a rectangular cross-section such as spatulas, tongue depressors and the like. In these embodiments, the elongate medical instrument port 310 is located below the mouth medical instrument entry port 150. However, in other embodiments, the elongate medical instrument entry port 310 can be located in any position on the respiratory face mask 10 as required. As shown particularly in Figure 8, while the elongate medical instrument entry port 310 can be sized as required, a width of about 20mm and a height of about 2.6mm is suitable.

[0073] The elongate medical instrument entry port 310 is formed in the clear panel 70 and is sealed with a flexible silicone flap layer 320 which can be bonded to the clear panel 70 at its bottom edge and sides to provide an access opening 330 at its upper edge through which a medical instrument such as a spatula or tongue depressor can enter i.e. flap layer 320 can be closed on three sides and remains open on one side. The silicone layer can return to its shape to close the elongate medical instrument entry port 310 after use.

[0074] Figures 14 to 16 show a further embodiment of a respiratory face mask 10 of the invention similar to the face mask 10 of Figure 7 but which is configured for nose and throat procedures. Like numerals indicate like parts. More particularly, in the present embodiment, the mouth medical instrument port 150 is omitted and the rectangular and slot-like medical instrument port 310 is located at the edge of the clear panel 70 towards a user’s chin area.

[0075] In addition, in the present embodiment, the slot-like medical instrument port 310 is longer than the slot-like medical instrument port 310 previously described and is flap layer 320 is door-like in construction and can be formed from the same material as the clear panel 70 (e.g. anti fog film). The door-like flap layer 320 is connected on one side and can be opened like a door to permit medical instrument access. The slot-like medical instrument port 310 can be laser cut so the tolerance is as tight as possible to prevent leaks.

[0076] As will be appreciated by those skilled in the art, the construction of the the slot-like medical instrument port 310 is interchangeable between embodiments as required.

[0077] Figures 17 and 18 show a further embodiment of a respiratory face mask 10 of the invention similar to the mask 10 of Figure 1 configured for gastrointestinal procedures. Like numerals indicate like parts. Accordingly, in the present embodiment, the nose medical instrument entry port 160 is omitted and the mask 10 is provided with both a large and a small mouth medical instrument entry port 150 for receiving two differently sized medical instruments as required.

[0078] Figure 19 shows a further embodiment of the respiratory face mask 10 of the invention similar to the face mask 10 of Figure 17 and like numerals indicate like parts. However, in the present embodiment, the mask 10 is shaped and configured to accommodate a bite block 340 to keep the patient's mouth open during a gastroscopy procedure.

[0079] In use, as shown particularly in Figures 4 and 5 and 12 and 13, a medical instrument 200 such as an endoscope or the like, is inserted through the medical instrument receiving opening 190 in the outer layer 180 of the entry port 140 and through the valve 170 via the guide lumen 178 to exit the medical instrument entry port 140 via the medical instrument exit 173 defined by the intersecting slits 240,260 at the apical tip 179 of the first and second wall layers 220,230. The sealing flaps 252 of the first and second wall layers 220,230 are therefore urged inwards from a fluid tight closed position as shown in Figures 2 and 3 and 9 and 10 to a fluid tight open position as shown in Figures 4 and 5 and 12 and 13 by the medical instrument 200. The sealing flaps 252 therefore frictional ly engage the medical instrument 200 as it passes through the medical instrument exit 173 to assist in controlling the movement of the medical instrument 200 and effectively assist in gripping the medical instrument 200 in use.

[0080] The valve 170 forms a highly effective fluid tight seal around the medical instrument 200 due to the offset relationship between the slits 240 of the first wall layer 220 and the slits 260 of the second wall layer 230 and the overlapping sealing flaps 252 - the sealing flaps 252 of the second wall layer 230 prevent fluid escape via the slits 240 of the first wall layer 220. Accordingly, the valve 170 serves as a one-way valve in use which provides a seal against fluid escape in use.

[0081] Where present, the elongate medical instrument entry port 310 can also be employed as previously described.

[0082] Accordingly, the valve 170 of the present embodiment forms two overlapping layers of sealing flaps 252 which prevent aerosol escape through the medical instrument opening 190. The resilient sealing flaps 252 grip medical instruments 200 in use and return to their original shape after use to maintain a fluid tight seal in the closed position. The overlapping resilient sealing flaps 252 allow for medical instruments 200 having a range of diameters to be inserted through the medical instrument entry port 140 whilst maintaining a fluid tight seal regardless of the diameter of the medical instrument 200.

[0083] The respiratory face mask 10 of the invention is typically formed as a fish-type folding mask made from three profiles, two that create a facial seal and the clear panel 70. The clear panel can be formed from an anti-fog polymer such as a polyester film. The medical instrument entry ports 140 can be formed from thin layers of silicone and the like. The breathable fabric of the face covering 30 can be made from three ply nonwoven polymer filter fabrics e.g. 2 x non-woven meltblown cloth and 1 x non-woven filter composite.

[0084] The medical instrument entry port 140 can be attached to the face mask 10 as a final manufacturing process step which will allow for product customisation to suit different requirements. In addition, the laminar medical instrument entry port 140 can be configured and sized as required in accordance with the size of the medical instruments to be used with the face mask 10.

Claims

Claims1 . A respiratory face mask (10) comprising: a face covering (30) for covering a nose (40) and mouth (50) of a patient (20), and a medical instrument entry port (140) on the face covering (30) comprising an outer layer (180) defining a medical instrument receiving opening (190) and a valve (170) at an inner face (181 ) of the outer layer (180) for preventing fluid escape through the medical instrument receiving opening (190) wherein the valve (170) comprises a generally conical sidewall (172) defining a medical instrument receiving aperture (171 ) at the medical instrument receiving opening (190); an opposite medical instrument exit (173) movable between a fluid tight open and a fluid tight closed position, and a guide lumen (178) extending between the medical instrument receiving aperture (171 ) and the medical instrument exit (173).

2. A respiratory face mask (10) as claimed in Claim 1 wherein the medical instrument exit (173) is formed at an apical tip (179) of the conical sidewall (172).

3. A respiratory face mask (10) as claimed in Claim 2 wherein the medical instrument exit (173) comprises a slit (240,260) extending from the apical tip (179) towards the medical instrument receiving aperture (171 ) to define a sealing flap (252) .

4. A respiratory face mask (10) as claimed in Claim 3 wherein the medical instrument exit (173) comprises at least two circumferentially spaced slits (240,260) extending from the apical tip (179) to define two sealing flaps (252).

5. A respiratory face mask (10) as claimed in Claim 4 wherein the medical instrument exit (173) comprises four circumferentially spaced slits (240,260) extending from the apical tip (179) to define four sealing flaps (252).

6. A respiratory face mask (10) as claimed in any of Claims 3 to 5 wherein the conical sidewall (172) comprises a first wall layer (220) and a second wall layer (230) abutting the first wall layer (220) in a laminar fashion.

7. A respiratory face mask (10) as claimed in Claim 6 wherein the first wall layer (220) and / or the second wall layer (230) have a tapered thickness towards the apical tip (179).

8. A respiratory face mask (10) as claimed in Claim 6 or Claim 7 wherein the first wall layer (220) comprises at least one slit (240,260) extending from the apical tip (179) to define a sealing flap (252) and the second wall layer (230) comprises at least one slit (240,260) extending from the apical tip (179) to define a sealing flap (252), the slits (240,260) being circumferentially offset to circumferentially offset the sealing flaps (252).

9. A respiratory face mask (10) as claimed in Claim 8 wherein slits (240,260) in the first wall layer (220) are circumferentially offset by up to about 90° with respect to slits (240,260) in the second wall layer (230).

10. A respiratory face mask (10) as claimed in any of Claims 1 to 9 wherein the face covering (30) comprises a clear panel (70) for viewing a patient’s nose (40) or mouth (50) and the medical instrument entry port (140) is provided on the clear panel (70).

11. A respiratory face mask (10) as claimed in Claim 10 wherein the clear panel (70) comprises a mouth medical instrument entry port (150) located at a mouth region (31 ) of the clear panel (70).

12. A respiratory face mask (10) as claimed in Claim 10 or Claim 11 wherein the clear panel (70) comprises a nose medical instrument entry port (160) located at a nose region (32) of the clear panel (70).

13. A respiratory face mask (10) as claimed in any of Claims 10 to 12 wherein the clear panel (70) forms the outer layer (180) of the medical instrument entry port (140).

14. A respiratory face mask (10) as claimed in any of Claims 10 to 13 wherein the conical sidewall (172) is contiguous with the outer layer (180).

15. A respiratory face mask (10) as claimed in any of Claims 1 to 14 wherein the medical instrument receiving opening (190) is circular in shape.

16. A respiratory face mask (10) as claimed in any of Claims 1 to 15 further comprising an elongate medical instrument entry port (310).

17. A respiratory face mask (10) as claimed in Claim 16 wherein the elongate medical instrument entry port (310) is rectangular in shape.

18. A respiratory face mask (10) as claimed in Claim 17 wherein the elongate medical instrument entry port (310) comprises an openable flap or door (320).

19. A respiratory face mask (10) as claimed in any of Claims 1 to 18 wherein the face covering (30) comprises a breathable fabric.

20. A respiratory face mask (10) as claimed in any of Claims 1 to 19 wherein the face covering (30) comprises an upper nose portion (100) with a contoured outer edge (110) configured to fit around a nose (40).21 . A respiratory face mask (10) as claimed in Claim 20 wherein the upper nose portion (100) is formed from a foam.

22. A respiratory face mask (10) as claimed in Claim 20 or Claim 21 wherein the upper nose portion (100) further comprises a nose clip (130).

23. A respiratory face mask (10) as claimed in any of Claims 1 to 22 wherein the face mask (10) is configured to receive a bit block (340).

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