Patent Description:
Some medical procedures carry a risk of medical practitioners being exposed to pathogens emanating from a patient's body or of noxious gases that may be generated during the medical procedures, for example when using cauterising devices. It is desirable to provide a barrier between the site of a patient's body from which such gases emanate and the medical practitioner.

Coverings for covering a part of a patient's anatomy for this purpose are known. However, some such coverings are both heavy and consequently cumbersome to handle, at least for a single medical practitioner, or are too flexible to provide a reliable barrier.

<CIT> discloses an isolation, sterilization and maximum observation tent for the isolation of a corpse during a medical procedure and to contain matter spilling from the corpse. The tent includes a frame and a form fitted translucent sheet supported by the frame, and will preferably have a continuous elastic band secured to the bottom edge of the sheet and an absorbent material treated with disinfectant, in close proximity thereto to prevent spillage of infectious material.

<CIT> discloses a sterile enclosure for performing medical procedures, such as an ophthalmologic surgery. The enclosure includes a lightweight, flexible housing material forming an enclosure, at least one equipment attachment region within the housing material, at least one subject attachment region within the housing material, at least one air intake port, at least one air exhaust port, and at least one user access port within the housing material.

According to the invention there is provided a covering for a body part of a patient according to claim <NUM>.

In an embodiment, a sheet of the plurality of sheets is a curved sheet that has a curvature in a first direction. A connection between the curved sheet and another sheet of the plurality of sheets forms an edge. In an embodiment, the curved sheet may be considered to curve about an axis that is parallel to the curved sheet along a second direction in which the curved sheet remains straight/is not curved. In one embodiment, the other sheet is planar and is arranged so that the sheet is not in a plane that comprises the axis. In another embodiment, the other sheet is another curved sheet that also curves about a direction and that also defines an axis that is parallel to the other curved sheet along a second direction of the other curved sheet in which the other curved sheet remains straight/is not curved. The axes of the curved sheet and of the other curved sheet are non-parallel.

The plurality of sheet segments comprises a plurality of openings for the insertion of arms into an inside of the covering, wherein the rigidity of the structure is sufficient for the dome structure to, when an arm is inserted into the chamber through an opening, resists movement thereby minimising or preventing expulsion of a gas within the covering to an outside.

In an embodiment, the plurality of transparent semi-rigid sheets may be made of a polymeric material.

The transparent semi-rigid sheet segments may comprise a material having a Flexural modulus of between <NUM> MPa and <NUM> MPa. The transparent semi-rigid sheet segments may have a thickness of between <NUM> and <NUM>. The opening hay have a widest dimension of between <NUM> and <NUM>.

In an embodiment, the fastening means may comprise a zipper and/or a hook and loop type fastening.

The total open area of each opening in a first state may be <NUM><NUM>, wherein in the first state no arm is inserted into the chamber and wherein the total open area is the area that provides fluid communication between the inside and outside of the chamber.

The total open area of an opening in a second state may be a maximum of <NUM><NUM>, wherein in the second state all openings have arms inserted into the chamber and wherein the total open area is the area that provides fluid communication between the inside and outside of the chamber.

At least one of the openings is covered by a flexible seal, the flexible seal may comprise an elastically deformable seal opening configured to admit a human arm through the seal opening.

In an embodiment, the flexible seal is configured to elastically assume a relaxed position when nothing is inserted through the seal opening, wherein in the relaxed position a fluid flow cross section through the seal opening is minimised or substantially eliminated. The flexible seal and the seal opening may be configured to deform around an inserted arm to create a maximum total opening area around the arm through the seal opening for fluid communication between the inside and the outside of the chamber of less than or equal to <NUM><NUM>.

There is provided a covering for a body part of a patient, comprising a structure for covering a patient's body part comprising a plurality of semi-rigid sheet segments and connected to each other along joins and forming a chamber between the structure and a surface upon which the structure rests and/or the patient. The covering may comprise a plurality of openings for insertion of arms into the chamber, wherein a part of the covering comprising said plurality of openings curves convexly outwardly so as to provide an unobstructed view into the chamber.

It will be appreciated that the covering may comprise the features of any of the hereinbefore-described coverings. A dome may have a substantially square base defining four sides, one or more or all of which curve towards an apex. In one embodiment, at least one opening is provided on each side.

The plurality of transparent sheet segments may comprise complimentary shapes configured to provide the self-supporting dome shape, with seams connecting the sheets positioned such that they are out of the line of sight of a human of average height manipulating a patient positioned horizontally at a height between <NUM> and <NUM> above ground.

More preferably, the seams connecting the sheet segments are positioned such that they are out of the line of sight of a human of average height manipulating a patient positioned horizontally at a height between <NUM> and <NUM> above ground.

For the purposes of this disclosure the average height of a human male is <NUM> and of a human female <NUM>. ICU beds can be height adjustable within a range of <NUM> to <NUM> above ground. The patient rests on a mattress that is approximately <NUM>-<NUM> thick. Operating tables have a height of between <NUM> and <NUM> above ground. The patient lies on a mattress that is between <NUM> and <NUM> thick. The transparent sheet segments of the covering curve such that any joints between adjacent transparent sheets are, for this range of resting height of the patient above ground and for these average human body heights, are not located within a line of sight of a human having his or her arms inserted into the covering through arm openings and looking to a centre of the inside of the covering.

There is provided a covering for a body part of a patient, comprising a substantially dome shaped structure for covering a patient's body part and forming a chamber between the dome and a surface and/or patient. The structure comprising edges that may, in use, be placed adjacent part of a patient's anatomy or a surface upon which a patient rests; wherein at least one of the edges comprises a pliable skirt for providing continuous contact between the base of the dome and a surface and/or a body part of a patient.

In an embodiment, the pliability of the skirt is such that it is not able to support its own weight in a manner that forms fluid flow channels between the skirt material and a surface upon which the skirt material rests.

It will be appreciated that the covering may comprise the features of any of the hereinbefore-described coverings.

The skirt may comprise accessible portions that are openable and closable to allow insertion of items into the chamber. The accessible portions may comprise double zips.

There is provided a covering for a body part of a patient, comprising a substantially dome shaped structure for covering a patient's body part and forming a chamber between the dome and a surface and/or patient. The covering may comprise a plurality of overlapping components, wherein overlapping components are connected using a spacer or spacers that allow for ingress of liquid between the sheets.

The covering may further comprise a pliable skirt arranged along at least one edge of the covering, the skirt overlapping a sheet material forming the edge and connected to the sheet material using a spacer or spacers that allow ingress of liquid between the sheet material.

The spacer or spacers may comprise a woven fluid permeable material.

According to an embodiment there is provided a set of semi-rigid sheets and fasteners, assemblable into a covering according to any preceding covering by connecting the sheets using the fasteners.

There is provided a safety apparatus comprising a substantially dome shaped covering for covering a patient's body part suitable for forming a chamber between the dome and a surface and/or patient. The covering may comprise a plurality of openings for insertion of arms into the chamber and an extraction means connectable to the chamber and suitable for continuously extracting gas from the chamber at a rate that creates an inflow of gas through the openings towards the extraction means, thereby preventing gas escaping from the chamber through the openings.

The extraction means may be in fluid communication with the chamber at two positions. The extraction means may comprise a tube having a first end and a second end, wherein the tube is in fluid communication with the chamber at the first end and connected to a pump at the second end. The extraction means may further comprise a gas filter positioned between the chamber and the pump, for filtering the gas extracted from the chamber. The extraction means may be configured to extract gas from the chamber at a rate of at least <NUM>/min.

<FIG> depicts an example of a covering <NUM> according to an embodiment. The cover <NUM> is substantially transparent such that it covers a patient's body part but the body part remains visible. The cover <NUM> comprises a dome <NUM> formed by a plurality of transparent sheet segments <NUM> shown in <FIG>. The plurality of transparent sheet segments <NUM> can comprise a single sheet comprising a specific shape or multiple separate sheets. It will be understood that the term transparent sheet segments and transparent sheets are used interchangeably herein. Transparent sheets are sheets that comprise at least a portion through which objects can be distinctly seen. The transparent sheets <NUM> are semi-rigid so that they can be curved and interlocked to form the dome shape <NUM>. The lower edges of the covering <NUM>/dome <NUM> are suitable for placing on a surface, for example a mattress <NUM>, whereby the dome remains self-supporting and upright on the surface. As shown in <FIG>, the covering <NUM> is positioned at the upper part of a mattress <NUM>, in this example covering a patients head and shoulders. The covering creates a chamber <NUM> between the dome <NUM> and the surface (mattress <NUM>) and/or the patient. It will be appreciated that the covering <NUM> could be positioned on a different part of the mattress <NUM> and/or to cover a different part of a patient's body.

The dome <NUM> provides a barrier between a person outside the covering <NUM> and the chamber <NUM> and, in doing so, blocks aerosols emanating from the patient/patient's body part from reaching the person outside. The chamber <NUM> encloses the patient's body part, in this example the patient's head and shoulders. Therefore, the dome <NUM> blocks fluids within the chamber reaching a person outside the covering regardless of where they are standing around the covering <NUM>.

As discussed above the dome <NUM> is self-supporting. This is achieved due to the semi-rigidity nature of the transparent sheets <NUM>. As shown in <FIG>, three transparent sheets <NUM> form the covering <NUM>. The three transparent sheets <NUM> are provided flat as shown in <FIG> and can be assembled in situ. <FIG> shows the sheets <NUM> fastened together to form dome <NUM>. Assembly is possible without the use of tools due to the use of a releasable fastener like the zip <NUM> shown in <FIG>. Although a zip is described, it will be understood than any suitable fastening means is encompassed by the present disclosure. These may include any fastening system that enables tool free and familiar assembly. This may be discrete system of multiple hook and loop features cut into the panels or series of press-studs. Additionally or alternatively continuous fasteners, such as zips or tongue and groove channels are used. The use of widely known fasteners allows assembly and disassembly of the dome <NUM> to be carried out quickly and without special training. The structure of the dome <NUM> allows the transparent sheets <NUM> to support each other, forming a self-supporting freestanding dome <NUM>. The dome <NUM> shown does not require additional structural members to enable it to maintain its shape, although such members can be added, if desired. An example of such additional structural members can be seen in <FIG>, where one structural member extends just above or below the arm openings in each of the semi-rigid panels. The additional structural member may be a fibreglass rod or a similarly rigid elongate member. Preferably any additional structural member extends across a widest portion of a semi-rigid sheet <NUM> in a direction that is orthogonal to the direction of curvature of the sheet <NUM>.

It will be appreciated that while the dome <NUM> shown in <FIG> comprises three transparent sheets <NUM>, in different embodiments the dome <NUM> may be formed using a different number of transparent sheets, such as one, two or four transparent sheets.

Whilst the semi-rigid sheets <NUM> can easily be curved to adopt the shapes shown in <FIG> and <FIG> respectively, once the semi-rigid sheets <NUM> are curved, the curved semi-rigid sheet <NUM> provides resistance against deformation in a direction orthogonal to the direction of its curvature. The perpendicular skin stiffness is capable of supporting 10N point load force and offer between <NUM> and <NUM> N/mm stiffness within this load range. The semi-rigid sheets <NUM> may, for example, be considered, in the configuration shown in <FIG> and <FIG>, to be curved about a horizontally extending axis that is parallel to the direction of the sheet in which the sheet has not been curved. As adjacent semi-rigid sheets <NUM> of the cover <NUM> are connected to the curved sheet and at a non-zero angle, the resistance against deformation the curved sheet provides in the direction orthogonal to its direction of curvature/along the parallel axis, the mutual support provided by connected sheets renders the assembled structure resistant to deformation to a degree that exceeds the deformation resistance of individual sheets in a flat state. As adjacent sheets are connected to each other continuously or at numerous points along an edge of the cover <NUM>, the sheets further support each other in retaining their curvature.

It is noted that for the purposes of the present disclosure the described curvature does not have to the cylindrical in nature and instead encompasses any curvature that fulfils the purpose of preventing connections between adjacent sheets from obstructing the line a few of medical practitioners.

The transparent nature of the sheets <NUM> in combination with the position of the fastening provides maximum visibility through the covering <NUM> to the chamber <NUM> to a person outside the covering <NUM>. The sheets <NUM> are formed from a material which exhibits light transmission property of greater than <NUM>% and light refractive index of less than <NUM>. The walls of the dome <NUM> are convex towards the outside, so that they curve toward an apex of the dome <NUM>. in the embodiment shown in <FIG>, the curved sheet at the top end of the cover <NUM> and the two curved sheets forming side walls protrude outwardly most at a height at which access openings for a medical practitioner's arms are provided. This curvature has the effect that the joints between adjacent panels are located away from a line of sight of a medical practitioner performing a procedure on the patient under the dome <NUM> so that they do not obstruct the medical practitioner's view, as shown by the broken line in <FIG> and <FIG>. It will be understood that, although these figures illustrate the unobstructed nature of the practitioner's view using an example of a practitioner manipulating a patient from a head-end of the dome <NUM>, the view afforded a practitioner accessing the dome <NUM> from a side is equally unobstructed given the curving nature of the side panels of the dome <NUM>.

The transparent sheets <NUM> also comprise openings <NUM> as shown in <FIG> and <FIG>. The openings <NUM> are for insertion of arms or equipment in to the chamber <NUM> for carrying out procedures on the patient in the chamber <NUM>.

The rigidity of the dome structure <NUM> also resists excessive movement of the covering <NUM> when arms or equipment are inserted into and/or extracted from the openings <NUM>. Thus, the semi-rigid sheets <NUM> prevents aerosol within the chamber <NUM> from being 'pumped' back at a medical practitioner through the openings <NUM> by movement of the covering <NUM>.

In the example shown in the figures, the transparent sheets <NUM> have a thickness of between <NUM> to <NUM>. The transparent sheets <NUM> are formed from Polyethylene terephthalate glycol-modified (PETG). It will be understood that other suitable materials are intended. These may include PET, PETG, PVC, Solvay's medical-grade Udel® PSU or Radel® PPSU plastic sheets. The structure has a high strength to weight ratio making it light enough for a single person to lift it and manoeuvre it to allow multiples uses, or fast removal form the patient's body part in an emergency. In one embodiment, the total mass of the assembled hood is less than <NUM>. It will be appreciated that the transparent sheets can be made of any material that provides the above discussed properties of being transparent and, when curved, can support the curvature off connected sheets as well as render the covering sufficiently rigid to withstand an amount of deformation during manipulation that would cause air trapped under the cover <NUM> to be expelled to an outside of the covering <NUM>. The resistance against deformation a curved sheet can provide depends on both its thickness and its Young's modulus. Preferably, the sheet has a flexural modulus, a measure of the stiffness/resistance to bending when a force is applied perpendicular to the long edge of a sample, of between <NUM> MPa and <NUM> MPa. For example, a flexural modulus (Ef) in this range can be achieved by using a sheet having a thickness (h) of approximately <NUM> to <NUM> and a Young's Modulus (E) of approximately 2000N/mm<NUM> and 2500N/mm<NUM> using the following equation for a <NUM>-point bending test: <MAT> where w and h are the width and thickness of the beam, L is the distance between the two outer supports of the <NUM>-point bending test, and d is the deflection due to the load F applied at the middle of the beam. d is calculated using the Young's Modulus of the material and the following equation: <MAT> and l, the second moment of area of the beam's cross-section, is calculated using the following equation for a rectangular beam:
<MAT> Thus, any combination of material and thickness which exhibits a flexural modulus in this range is suitable.

One or more or all of the lower edges of the dome <NUM> is arcuate and sized to allow part of the patient's anatomy to protrude to an outside of the dome <NUM>, as shown in <FIG> and <FIG>. The arcuate edges are sized such that the patient's anatomy can comfortably pass under the edge of the dome <NUM> without pressure from the weight of the dome <NUM> or from forces applied to the dome <NUM> when a procedure is performed on the patient being applied to the patient's skin by the edge of the dome <NUM>.

One or more or all of the lower edges of the dome <NUM> is connected to a pliable skirt <NUM> as shown in <FIG> and <FIG>. The pliable skirt <NUM> is made of a material that, in use, is not capable of supporting wide arcuate structures that could form a channel for gas flow out of the dome <NUM>. The skirt <NUM> is thus made of a material that, when smoothed over a surface, be that part of the patient's body or part of a bed or operating table the patient rests on, the pliable skirt <NUM> substantially follows the surface closely. The total weight of the pliable skirt is less than <NUM>. In an embodiment, the pliable skirt <NUM> is less than <NUM> thick. As can be seen from the figures, the pliable skirt <NUM> can be provided as a way of sealing along the above-discussed arcuate edges. Additionally the pliable skirt may be provided along straight edges of the dome <NUM> to provide a means/skirt that can be tucked under a mattress on which the patient lies to prevent egress of gas from the dome <NUM>. The pliable skirt <NUM> is non-porous to prevent the escape of any contaminated liquids from within the chamber <NUM> and to be airtight to prevent excessive airflow into the chamber <NUM>. The pliable skirt <NUM> is formed from one or a combination of polyester, nylon and paper. In an embodiment, the pliable skirt is formed from DuPont Tyvek™ paper based material.

In use, the pliable skirt <NUM> drapes over a patient's body part and/or the sides of the mattress. The pliable skirt <NUM> is liquid impermeable so that fluids are not absorbed by it. In an embodiment, the skirt <NUM> is a woven polymer, for example polyester, impregnated with rubber. The skirt <NUM> conforms to the shape of the patient's anatomy and the patient can assume any desired resting position using the same covering <NUM> and without need to remove or readjust the covering <NUM>.

<FIG> and <FIG> illustrate the covering in use in several patient positions. Fig. <NUM> (a) shows the covering <NUM> in use where the patient's upper body is inclined upwardly by <NUM>°. <FIG> and <FIG> show the patient on their front and back respectively. The skirt <NUM> provides a side opening of flexible size and position, allowing the patient's arm position to be changed to suit the comfort and/or treatment requirements. Tests elevating a patient's body at various angles have shown that the pliable skirt <NUM> provides the desired sealing at least from an elevation of <NUM> degrees to <NUM> degrees.

<FIG> shows the opening <NUM> in a transparent sheet <NUM>. Depending on the requirements, the transparent sheet <NUM> may have no openings or it may have multiple openings <NUM>. The openings <NUM> comprise a substantially circular aperture in the sheet <NUM>. The openings <NUM> have, in some embodiments, opening diameters of between <NUM> and <NUM>. Preferably, the openings <NUM> have a diameter of <NUM> which allows the average arm size to be inserted through the opening. It will be appreciated that, whilst the figures show circular openings <NUM>, the openings may for example, be oval, square, rectangular or any other polygonal shape. The length of the widest dimension of the opening <NUM> is between <NUM> to <NUM>, preferably <NUM>.

The aperture of the opening <NUM> is enclosed with a flexible material <NUM> having an elongate slit <NUM>. The presence of the flexible material and the elongate slit <NUM> allows a person to insert their arm into the inside of the dome <NUM> through the slit <NUM> whilst minimising the amount of airflow between the inside and outside of dome <NUM> through the opening <NUM>. As shown in <FIG>, the flexible material <NUM> maintains contact with an arm inserted through the opening <NUM>, as shown in Fig. <NUM> (b) so that residual airflow through the opening <NUM> is limited to the areas <NUM> adjacent either end of the slit <NUM>. The total open flow area for each opening <NUM> in the transparent sheets <NUM> of the dome <NUM> is <NUM><NUM> in the configuration shown in <FIG> or Fig <NUM> (a), with no arm or medical device is inserted through the elongate slit <NUM>. Fig. <NUM> (b) shows the configuration of the openings <NUM> when an arm is inserted into the slit <NUM>, creating open areas <NUM> between flexible material <NUM> and the inserted arm. The open area <NUM> on either side of the arm has a maximum area of <NUM><NUM>. The increase in open area is minimised by flexible material <NUM>. Flexible material <NUM> allows for arms of varying sizes to be inserted without the need to increase the size open areas <NUM> provided in the transparent sheet <NUM>. In an embodiment, the flexible material <NUM> comprises a low friction surface, which prevents snagging of the protective clothing on the arm on the covering <NUM>. The openings ensure a relatively open access allowing free one handed and blind (no requirement to look) passage with or without holding equipment. The flexible material <NUM> is made from silicon rubber of thickness <NUM> to <NUM>. Mechanical property of the material is shore hardness between <NUM> and <NUM>, elongation at break > <NUM>% and tear resistance >15kN/mm. Silicon rubber exhibits excellent resistance to chemical decontamination fluids.

As illustrated in <FIG> the covering <NUM> of an embodiment comprises up to four faces. There are two arm openings <NUM> on one of the faces of the dome <NUM>. In use, the face having two arm openings <NUM> is positioned at the head and of the patient where a medical practitioner can insert his or her arms for carrying out a procedure. The opposite face and the side faces provide side access to the patient's body part whereby a second medical practitioner can insert one arm in the side face and one arm at the base of the head and third medical practitioner can do the same on the opposite side of the head, if required.

The configuration shown in the figures provides six arm openings <NUM>. Therefore, it allows up to three medical practitioners to perform procedures on a patient in the chamber <NUM>. As shown in <FIG> and Fig <NUM> several medical practitioners can be positioned around the covering. This is particularly suitable for intubation and extubation procedures where an anaesthetist works at arm's length from the top of the patients head peering down into the chamber through the dome <NUM> while assistants may approach the patient using the side and foot end aperture. Other procedures for which the covering <NUM> is beneficial include on ward care in prone and supine positions, tracheostomy clean/tube change, nursing daily care procedures, percutaneous tracheostomies, orthodontic procedures, post Covid-<NUM> recovery clinics, pulmonary procedures, electrosurgical cutting procedures that generate carcinogenic gases, nasendoscopy procedures. As discussed below, the covering <NUM> can be deployed in conjunction with extraction system <NUM>, <NUM>, <NUM> enabling clinicians to provide non-invasive ventilator procedures like CPAP, THRIVE or Opti-Flow which otherwise would present higher risk of the spread of Covid-<NUM> virus to the clinicians.

<FIG> shows an opening <NUM> proximate to the apex of the covering <NUM>. Opening <NUM> is suitable for insertion of tubing required for treatment. For example, opening <NUM> allows passage of ventilation system and pipes into the chamber <NUM>. The opening <NUM> comprises a substantially circular aperture in the semi-rigid transparent sheet <NUM> and a flexible material enclosing an elongate perforation. As with the arm openings <NUM>, the flexible material of opening <NUM> deforms around the contours of the inserted tubing to minimise the additional opening, and hence additional airflow possible, created between the inside and the outside of the chamber <NUM>.

<FIG> shows the dome <NUM> positioned on a surface wherein skirt <NUM> is draped outwards from the base of the dome <NUM>. In use, the skirt <NUM> is suitable for tucking under a mattress or the sides of the patient to reduce the openings between the inside and outside of the chamber <NUM>. As shown in <FIG> portions of the skirt <NUM> comprise a double zip <NUM> (i.e. a zip with two sliders that allow the opening of the zip <NUM> between the two sliders without needing to open the zip all the way to an end of it) extending from the base of the dome. The double zip <NUM> provides quick access for pipes and equipment into the chamber <NUM>.

<FIG> illustrates an arrangement for use in cleaning the covering <NUM> so that it can be reused. When the cover <NUM> is disassembled, i.e. when the sheets <NUM> are not connected to each other along their edges, the semi-rigid nature of the sheets making up the cover allows the sheets to be rolled into a tubular shape, which can be submerged in decontamination fluids. The covering <NUM> comprises materials that can withstand such decontamination fluids, for example chlorine-based disinfectants. The covering <NUM> in tube form is initially submerged by dipping it, in a longitudinal direction relative to the tube axis, into the container of decontamination fluid <NUM>. Depending on the size of decontamination container the covering <NUM> in tube form can be turned <NUM>° to be submerged from the other end of the tube if the decontamination container is not large enough to receive the covering <NUM> completely without turning. In an embodiment, looped fabric lifting handles are provided at each end for this operation. <FIG> shows a permeable bag which is used to retain the covering <NUM> in a rolled up form. The permeable bag comprises a porous weave, shown in <FIG> to allow flow of the decontamination fluids around the covering <NUM>. As shown in <FIG> the permeable bag has two handles to allow the covering <NUM> to be submerged from two ends to ensure even submersion. The covering <NUM> is then dried for reuse. Alternatively, the covering may be mass-produced so that cleaning is not required. In this case, the system is disposed of after use by de-construction and placing in an incineration sack.

<FIG> shows a cross section of the join <NUM> between the fastener <NUM> (i.e. a zip for example) and the transparent semi-rigid sheet <NUM> of the covering <NUM>. The join or seam <NUM> between the components, and any components of the covering <NUM> (e.g. the flexible material <NUM> of the openings <NUM>), comprises a permeable spacer <NUM>. The permeable spacer <NUM> allows ingress of liquid, in particular decontamination fluid, to the space between the semi-rigid sheet <NUM> and fastener <NUM>. It will be appreciated that, if two pieces of sheet material were in direct contact with each other (i.e. without the presence of the permeable spacer <NUM>), contaminated liquid present within the covering <NUM> may seep into the space between the two pieces of sheet material through capillary action and be retained in this space, even when the cover <NUM> is submerged in decontamination fluid. Whilst providing the spacer <NUM> does not prevent contaminated gases and fluids from entering in the space between the two overlapping sheets, the presence of the spacer <NUM> prevents retention of any contaminants between the two overlapping sheets through capillary action. Moreover, the presence of the spacer allows easy ingress of decontamination fluids during a decontamination procedure so that the decontamination fluid can reach spaces of the cover <NUM> that would otherwise be difficult or impossible to access. In so doing, the permeable spacer <NUM> prevents build-up of pathogens in this space. Thus, the covering <NUM> can be completely cleaned and is safe to reuse in a medical environment. A major drawback of known covers is the use of wipe down procedures because of the large surface area it is difficult to ensure <NUM>% coverage using a wipe down method. As such, the described covering <NUM> is suitable for complete cleaning by full submersion into, for example, a chlorine based disinfectant solution. Alternatively, the components are glued together or are integrally formed.

It will be appreciated that, whilst the structure of the join shown in <FIG> is described with reference to the join between a semi-rigid sheet <NUM> and a fastener <NUM>, any join used in the cover <NUM> can be configured using this structure, including the joins between semi-rigid sheet <NUM> and flexible material <NUM> and between semi-rigid sheet <NUM> and pliable skirts <NUM>. It will equally be appreciated that, in an alternative embodiment, the join is created by providing an adhesive between overlapping areas of material so that gaps that could harbour contaminated fluids are eliminated.

In an embodiment, the cover <NUM> is as described in relation to any of <FIG>. However, it will be understood that an alternative cover could be used, not least for different procedures. For example, the embodiments of the cover shown in <FIG> are particularly useful for observation, diagnosis and post Covid-<NUM> recovery clinics.

It will be understood that the features described above in relation to <FIG> are also applicable to the covering of <FIG>. As shown, cover <NUM> comprises a dome <NUM> formed by a single transparent sheet <NUM>. The single transparent sheet comprises a blank having segments. The sheet <NUM> can have numerous shapes as shown in shown in <FIG>). In the embodiments of <FIG>and <FIG> and the embodiments shown in <FIG> the blank comprising three segments. In the embodiments of <FIG> the blank comprising only two segments The blanks comprise fold lines, for example a thinner portion of material, around which the foldable segments can be adjusted to form the self-supporting structures shown in <FIG>. The free edges of the sheet segments are fastenable to each other via means already discussed.

Whilst coverings made of two, three and four segments are discussed in detail herein it will be appreciated that coverings made from a larger number of segments are also encompassed by the present disclosure. It will moreover be understood that, whilst <FIG> show embodiments in which the segments forming the covering are connected to each other so that they are assemblable from a single piece of semi-rigid sheet material, the individual segments could equally be separate from each other when delivered and then connected to each other during assembly to form the shape of the covering.

As discussed the cover <NUM> has openings <NUM>, <NUM> for the insertion of tubing and/or arms for treatment of the patient. The openings are as shown in <FIG> and <FIG> and described in detail above. In this embodiment, the lower edges of the covering <NUM> are suitable for placing on a patient's shoulders, whereby the dome remains self-supporting and upright on the shoulders and covering the patients head to prevent spread of aerosols from the patient to the clinician.

<FIG> shows a safety assembly according to an aspect of the present disclosure. The safety apparatus comprises a cover <NUM> connected to an extracting means <NUM>. The cover <NUM> is as described in relation to any of <FIG>. However, it will be understood that an alternative cover could be used, not least for different procedures. The extracting means <NUM> is a fan <NUM> suitable for continuously extracting fluids. As shown in <FIG> the assembly further comprises tubing <NUM>, which attaches to the cover <NUM> via one or two openings <NUM>. In a preferred embodiment, extraction from two sides of the cover <NUM> is used to provide better air circulation over the patient. This helps prevent build-up of condensate within the cover <NUM> and provides evenly distributed cooling airflow passing over the patient. The use of two extraction points moreover prevents a situation where an inadvertent occlusion of one extraction point prevents extraction of air from the covering <NUM>. One of the extraction openings <NUM> is shown in <FIG>. The openings <NUM> is positioned proximate to the base of the dome <NUM> such that in use they are proximate a patient's shoulders. The openings <NUM> comprise an inlet surrounded by flexible material <NUM> as described in relation to the arm openings <NUM> and tube opening <NUM>. The join <NUM> between the transparent semi-rigid sheets and the flexible material <NUM> of the opening <NUM> is as described above in one embodiment.

A filter <NUM> is positioned between the covering <NUM> and the extraction means <NUM>. The extraction means <NUM> is in fluid communication with the inside of the covering <NUM> via the tube <NUM> and filter <NUM> so that it extracts gas, i.e. aerosol, from the chamber <NUM> and pulls it through the filter <NUM> before expelling the gas into the surrounding environment. It is found that standard, low cost clinical filters, for examples those rated at HEPA H14 used in the clinical routine are suitable for decontaminating gas extracted continuously from the covering <NUM> using a flow rate of ><NUM>/min.

The extraction means <NUM> comprises a low level and unobtrusive air extraction system with specific airflow rate to overcome aerosol escape during procedures with up to three clinicians simultaneously. The filter <NUM> and extraction means <NUM> comprise standard tubes <NUM> and filter cartridges <NUM>. The tubes <NUM> and filter cartridges <NUM> are disposable after use.

<FIG> illustrates a numerical model used in simulating the extraction of aerosol from the chamber <NUM> during a procedure requiring six arms inside the chamber <NUM>. Fig. <NUM> shows results of the numerical simulation, illustrating the airflow path surrounding the openings <NUM>, <NUM>, <NUM> in the covering <NUM> when the extraction means <NUM> is in use. The simulation is 3D, Steady State, Detached Eddy Simulation (DES) run using the Spalart-Allmaras Viscous Model, in ANSYS Fluent software. Fig. <NUM> shows the effectiveness of the extraction at reducing escape of aerosol through the openings when the extraction fan continuously extracts fluid from the chamber at <NUM>/min. <FIG> display the gaps around the covering that potentially allow fluid communication between the inside of the chamber and the outside of the chamber. The blue lines indicate that, when arms are inserted into the chamber creating gaps <NUM>, air is sucked into the chamber <NUM> through the gaps <NUM> by the extraction means <NUM>, rather than escaping. Therefore, the medical practitioners are protected from any aerosols emanating from the patient within the chamber <NUM>.

While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions. The size of the dome <NUM> is adaptable to fit different bed sizes and designs. The dome <NUM> can be affixed to a bed/mattress for example when the patient is inclined toward a siting up position <FIG> or for patients in transit <FIG> using fixation straps. Furthermore the dome <NUM> will generally fit patients of all sizes for example including range of body sizes, e.g. <NUM>, <NUM> - <NUM>, <NUM>, and can also be scaled up or down depending on the procedure.

It will be appreciated that, while the coverings described herein mainly focus on covering sized to fit the human head and upper body, coverings for other parts of a patient's anatomy are equally covered by the concepts disclosed herein. In particular, any coverings of other parts of a patient's body making use of the concepts described herein are encompassed by the present disclosure. Such coverings are useful for procedures other than those performed on the head of a patient. Surgery using cauterising surgical equipment, for example, is known to generate noxious gases. A covering of the body part subject to such surgery can protect medical personal from exposure to such gases and can be easy applied to and removed from the patient for the relevant surgical steps.

Claim 1:
A covering (<NUM>) for a body part of a patient, comprising;
a plurality of transparent semi rigid sheet segments (<NUM>),
a releasable fastener (<NUM>) for connecting the plurality of sheet segments (<NUM>) together such that the sheet segments support each other to form a self-supporting structure (<NUM>) suitable for covering the body part of a patient;
wherein the plurality of sheet segments (<NUM>) comprise a plurality of openings (<NUM>) for the insertion of arms into an inside of the covering (<NUM>),
wherein the rigidity of the structure (<NUM>) is sufficient for the dome structure to, when an arm is inserted into the chamber (<NUM>) through an opening (<NUM>), resist movement thereby minimising or preventing expulsion of a gas within the covering (<NUM>) to an outside.