Patent Description:
More particularly, the present invention has as its object a disposable protective device for protecting a healthcare worker as well as a patient and thus capable of being disposed of, after use, by standard hospital disposal processes.

The devices designed to isolate a patient, specifically a patient presumed to be suffering from airborne infectious diseases such as influenza viruses, coronaviruses, viral infections such as mumps and rubella, meningitis, and other serious bacterial infections, are currently known. As is known in these cases, contagion occurs through droplets or droplets of saliva or sputum emitted through coughing, sneezing, emesis or even through phonation.

Examples of devices of the known art are described in documents <CIT>, <CIT> and <CIT>.

The document <CIT> describes a closed, collapsible capsule for isolating the patient to prevent a flow of contaminants to and from the patient. The capsule further comprises a number of sections that are transparent, flexible and also resistant to biochemical agents. Further, the capsule includes a plurality of glove box-like hermetic accesses to allow access and operations of an operator as well as manifolds to allow insertion of oxygen or other fluids, intravenous connections and more. Finally, the device described in <CIT> includes an artificial ventilation and filtration system.

The document <CIT> describes an inflatable container capable of enclosing a controlled atmosphere volume for use as an incubator or oxygen therapy tent. The side sections are flexible sheets that are folded and designed to be inflated to become load-bearing elements of the device. Once inflated, the device forms an air barrier in a volume around the patient.

The known technique described includes some major drawbacks.

In particular, both documents <CIT> and <CIT> describe devices that are bulky and not suitable for easy transport and positioning in emergency situations.

Again, both devices described in documents <CIT> and <CIT> require external devices such as compressors, oxygen cylinders, and power supply devices that do not make them usable in any environment.

In order to overcome some of the problems of the aforementioned known technique, it is possible to adopt devices as described, for example, in patent applications <CIT>, <CIT>, <CIT> or <CIT>.

The document <CIT> describes a device including transparent deformable walls and a plurality of coupling means for allowing the walls to be coupled onto an external frame so as to be suspended at least over the head of a user. Such a device is, therefore, substantially collapsible and allows access of oxygenation ducts through two nozzles arranged on the wall.

The document <CIT> describes, on the other hand, a collapsible structure comprising an inflatable frame capable, when filled with air, of forming a load-bearing box-like structure enclosed by flexible transparent walls.

The access is provided by hinges and/or holes in at least one wall.

The document <CIT>, on the other hand, describes a collapsible containment device provided with hinges and other means of closure suitable for hermetically sealing the torso and head of a user within a predetermined volume. The document <CIT> describes a tented device in which access to the internal volume is only via hermetically gloved accesses and in which the structure has a significant impact on the visibility of the operator with respect to the user whose head is disposed within the internal volume of the structure.

Even the known technique just described includes some major drawbacks.

In particular, the device described by <CIT> requires an external structure in order to be used and, therefore, is not substantially easy to use, for example, on transfer patients who need to be transported.

The device described by <CIT> must be inflated in order to function properly, and is therefore not suitable for use in emergency situations where speed is required. In addition, the device of <CIT> does not allow access to the internal volume and is therefore unsuitable for use on patients requiring surgery or other operator manoeuvres.

In conclusion, the device of <CIT> essentially deprives the operator of the visibility necessary for the correct manipulation of the user's head and reduces the manoeuvrability by using access through gloves.

In this situation, the technical task underlying the present invention is to devise a protective device for protecting an operator from airborne infectious diseases capable of substantially obviating at least part of the aforementioned drawbacks.

In the context of said technical task, it is an important aim of the invention to obtain a protective device for protecting an operator from airborne transmissible infectious diseases which provides high visibility of the user's head to enable the operator to carry out interventions with great efficiency.

Another important purpose of the invention is to achieve a protective device for protecting an operator from airborne communicable infectious diseases which increases the possibility of movement of the operator's limbs allowing the operator to perform wider and more precise movements.

The specified technical task and purposes are achieved by a protective device for protecting an operator from airborne communicable infectious diseases as claimed in the annexed claim <NUM>.

Preferred technical solutions are disclosed in the dependent claims.

The features and advantages of the invention are hereinafter clarified by the detailed description of preferred embodiments of the invention, with reference to the appended drawings, in which:.

With reference to the Figures, the protective device for protecting an operator from airborne infectious diseases according to the invention is globally referred to as device <NUM>.

Preferably, the device <NUM> is suitable for protecting an operator when handling a user suffering from airborne infectious diseases. In any case, the device <NUM> may find efficient use in any action in which it is of importance to create, as required, a chamber with a controlled environment for the head <NUM> of a user <NUM>.

Therefore, the device <NUM> is capable of providing at least the function of isolating a health care operator <NUM> from the user <NUM> and the user <NUM> from the external environment during the performance of treatments on the user <NUM>, operative interventions, hospital stays, the transfer of users <NUM> between departments, transport by ambulance or other means, waiting in environments with a high concentration of people, such as emergency rooms, during roadside rescue operations, or in general for the creation of a negative pressure environment for oxygen administration in treatments requiring it.

Furthermore, the device <NUM> may also simply be capable of allowing proper observation of the user <NUM> by the operator <NUM> or may, in at least one embodiment, allow the operator <NUM> to operate on the user <NUM> via one or more of its own limbs <NUM>.

Thus, the device <NUM> may also be capable of allowing the introduction of at least one limb <NUM> of the operator <NUM> for manipulation of the user <NUM>.

In summary, the device <NUM> comprises at least one frame <NUM> and a cover <NUM>.

The frame <NUM> is preferably a frame similar to common igloo tent frames. Thus, the frame <NUM> is shaped approximately like a pavilion vault with a quadrangular base, for example square or rectangular, as shown in <FIG>. By the term approximately, it is meant that the shape need not be perfect, but is roughly assimilated to it.

Thus, the frame <NUM> preferably comprises at least two rods <NUM>. Such rods <NUM> are substantially two curved or bendable elements whose ends start from the same plane and preferably cross each other at a maximum point.

Thus, the rods <NUM> are essentially mutually crossed at a crossing point 2a.

The crossing point 2a preferably corresponds to the top, or rather the highest point above the ground, of the frame <NUM> when the device <NUM> is in use, for example, on a flat surface provided by a table top or the ground itself.

The cover <NUM> is, therefore, supported by frame <NUM>. Therefore, in use, the cover <NUM> is shaped according to the shape imposed by the frame <NUM>. Preferably, therefore, the cover <NUM> is mostly defined by a deformable membrane layer.

Thus, cover <NUM> defines walls <NUM>. The walls <NUM> are essentially parts of the cover <NUM> delimited by the rods <NUM>. By this is not meant that the walls <NUM> are separate from each other, but that they are, although in one piece, simply distinct from the rods <NUM>.

In detail, the walls <NUM> comprise at least one front wall 30a, a rear wall 30b and side walls 30c. The front wall 30a includes at least one first access <NUM>. The first access <NUM> may be trivially defined by a hole cut in the front wall 30a.

In particular, the first access <NUM> is preferably capable of allowing a user <NUM> to insert their head <NUM> therein.

In contrast, the rear wall 30b is opposite the front wall 30a. Preferably, the rear wall 30b is the wall through which the operator <NUM> views at least the head <NUM> of the user <NUM>. Thus, advantageously, the at least rear wall 30b is transparent.

The side walls 30c are, therefore, preferably arranged between the front walls 30a and the rear walls 30b.

Of course, the side walls 30c and/or the front wall 30a could also be transparent. Preferably, in the preferred embodiment, all the walls <NUM> are transparent.

The cover <NUM> also preferably defines a bottom <NUM>. The bottom <NUM> is substantially flat, at least when resting on a surface, and is defined by the part of the cover <NUM> subtended by the walls <NUM>. Thus, the bottom <NUM> is substantially adjacent to and surrounded by all the walls <NUM>.

The cover <NUM> therefore also defines a chamber <NUM>. The chamber <NUM> is substantially bounded by walls <NUM> and bottom <NUM>. Thus, the chamber <NUM> is nothing more than the volume bounded by the walls <NUM> and bottom <NUM> and is configured to accommodate at least the head <NUM> of the user <NUM>.

The head <NUM> of the user <NUM> is, therefore, inserted into the chamber <NUM> via the first access <NUM>.

Advantageously, the device <NUM> comprises certain special features.

The crossing point 2a, in fact, defines a projection point 2a' on the off-centre bottom <NUM>. The projection point 2a' is nothing more than the point of intersection between the bottom <NUM> and a line perpendicular to the bottom <NUM> passing through the crossing point 2a.

The projection point 2a', therefore, is closer to the front wall 30a than to said rear wall 30b.

In this way, the frame structure <NUM> is slightly inclined. More importantly, said rear wall 30b turns out to be more extended increasing the visibility of the chamber <NUM> from the outside, or rather the visibility of the operator <NUM> with respect to the head <NUM> of the user <NUM>.

Advantageously, in addition, the rear wall 30b may comprise at least a second access <NUM>.

The second access <NUM>, if present, is preferably configured to allow insertion of a limb <NUM> of the operator <NUM> so that the latter can easily manipulate at least the head <NUM> of the user <NUM>.

The second access <NUM> is, therefore, preferably made by at least one notch <NUM>.

The notch <NUM> is substantially cross-shaped, or T-shaped, or L-shaped, made on the cover <NUM>. Thus, the flaps of the cover <NUM> separated by the notch <NUM> are deformable so as to allow the introduction of the limb <NUM> of the operator <NUM> into the chamber <NUM>. The notch <NUM>, in particular, is determined by a horizontal groove 50b and a vertical groove 50a.

The horizontal groove extends parallel to the bottom <NUM>. The vertical groove 50a, on the other hand, extends transversely to the bottom <NUM>, and thus also to the horizontal groove 50b.

Advantageously, the vertical groove 50b defines a length at least equal to <NUM>/<NUM> of the extension defined by the rear wall 30b between the intersection 2b and the bottom <NUM>. Furthermore, advantageously, the vertical groove 50b extends at least up to above half of said extension defined by the rear wall 30b between the intersection 2b and the bottom <NUM>, starting from a position close to the bottom <NUM>.

Thanks to these features, the limb <NUM> of the operator <NUM> has extreme mobility within the chamber <NUM> and allows, above all, the operator <NUM> to manoeuvre while maintaining an upright posture with full visibility of the head <NUM> of the user <NUM>, as shown in <FIG>. In fact, thanks to the extension of the groove 50b, the limb <NUM> can assume a position transverse to the bottom <NUM> and does not necessarily have to be introduced parallel to it.

The latter aspects may be of paramount importance when the device <NUM> is used to surgically operate the user <NUM> and when, therefore, a high degree of precision dependent on mobility is required.

The rear wall 30b could also comprise two second accesses <NUM>. If present, they could be placed side by side in such a way as to allow the operator <NUM> to insert both limbs <NUM>, simultaneously, within the chamber <NUM>.

In addition, one or more of the side walls 30c could also include one or more second accesses <NUM>. The latter could be useful in particular situations where it is necessary to operate on the head <NUM> of the user <NUM> from a different angle.

The second access <NUM> could then be freely accessible, or could be accessible after removal of a protective partition <NUM>.

Therefore, preferably, the cover <NUM> comprises at least one protective partition <NUM> configured to cover or make accessible, on command, the second access <NUM>. If present, a protective partition <NUM> may be laboriously constrained to the rear wall 30b, or also to the side wall 30c. In a preferred embodiment, the protective partition <NUM> may be a film constrained only superiorly to the wall <NUM> in such a way that it can be folded upwards before introducing the limb <NUM> within the second access <NUM>.

Naturally, when the second access <NUM> is released, the protective partition <NUM> falls back into position to cover the second access <NUM> by virtue of the gravitational gradient.

The device <NUM> may also include further advantageous arrangements.

For example, it may comprise a membrane <NUM>.

The membrane <NUM>, if present, is preferably constrained to the front wall 30a. Thus, it is substantially configured as an extension of the front wall 30a beyond the cover <NUM>. The membrane <NUM> is, therefore, preferably configured to at least partially surround the first access <NUM>. In this way, the membrane <NUM> realises, in use, an access conduit <NUM>. The access conduit <NUM> is substantially communicating with the chamber <NUM>.

Furthermore, within the access conduit <NUM> can be housed, and covered by the membrane <NUM>, the thorax of the user <NUM> whose head <NUM> is housed in the chamber <NUM>. The membrane <NUM> may be fully secured to the cover <NUM>. Or, the device <NUM> may comprise locking means <NUM>.

If present, the locking means <NUM> are configured to removably constrain, on command, at least part of the membrane <NUM> and the anterior wall 30a.

For example, the locking means <NUM> may include one or more Velcro portions <NUM>. These Velcro portions <NUM> may then be positioned partly on the membrane <NUM> and partly on the anterior wall 30a. Thus, they may be distributed around at least part of the access <NUM>.

The device <NUM> could also further include constraining means <NUM>.

If present, the constraining means <NUM> are configured to allow the binding, on command, of the device <NUM> to an external object.

For example, they may include one or more laces <NUM>. The laces <NUM> may, therefore, be distributed around the bottom <NUM>. The laces <NUM> may allow the device <NUM> to be constrained to a stretcher, rather than to another structure defining long elements around which the laces may be knotted.

The device <NUM> may also comprise a handle <NUM>. If present, the handle <NUM> could be configured to allow the device <NUM> to be lifted with one hand of the operator <NUM>. Thus, the handle <NUM> could basically include at least one loop <NUM>. The loop <NUM> may then be made from a simple strip whose ends are mutually constrained or bound at the same point. Advantageously, the loop <NUM> may be constrained at the junction 2a.

In addition to what has been described, one or more of the walls <NUM> may include one or more third accesses <NUM>. The third accesses <NUM>, if present, are advantageously configured to arrange the chamber <NUM> in fluid passage connection with a respective fluid suction or input pipe from the outside.

In this regard, the third accesses <NUM> can be made from cross slots, similarly to the second accesses <NUM> but with smaller dimensions, or they can also include connectors that can be plugged and opened as required. In addition, third accesses could also be covered by protective partitions similar to the protective partitions <NUM> of the second accesses <NUM>.

In terms of materials, frame <NUM> and cover <NUM> can be realised in different ways. Preferably, the rods <NUM> are made of harmonic steel, but could alternatively be made of resin or other materials that are sufficiently strong and, at the same time, elastic. In contrast, the cover <NUM> comprises a deformable polymeric material. In particular, the material of cover <NUM> is deformable in such a way that said device <NUM> is fully collapsible.

The device <NUM> is, in fact, preferably intended to be used only once by a single person and then disposed of.

Thus, preferably, the device <NUM> makes it possible to make a disposable protective kit to protect an operator from airborne infectious diseases.

The kit thus comprises, in addition to device <NUM>, an envelope defining a thinned housing space. The device <NUM> is then, prior to use, collapsed and entirely housed and sealed within the housing space of the pouch.

More specifically, preferably, the device <NUM> is packaged in a heat-sealed plastic envelope on which may, in addition, be present all the legal indications and instructions necessary for the use of the device <NUM>.

The operation of device <NUM> described above in structural terms is as follows. Basically, once extracted from the kit housing envelope, the device <NUM> can be opened in such a way as to define the chamber <NUM>, possibly with the aid of the handle <NUM>. Then, the head <NUM> of a user <NUM> can be introduced into chamber <NUM> by means of the first access <NUM> via the access conduit <NUM> made by the membrane <NUM>. At this stage, the membrane <NUM> can be at least partially free so as to facilitate the introduction of the head <NUM> and then it can be fully constrained to the anterior wall 30a, by means of the locking means <NUM>, once the head <NUM> has been introduced so as to secure the membrane <NUM> on the chest of the user <NUM>. Possible limb accesses <NUM> of the operator <NUM> can be completed thanks to the second accesses <NUM>. In any case, the head <NUM> of the user <NUM> always remains reclined in the chamber <NUM> and remains clearly visible before the eyes of the operator <NUM> at least through the posterior wall 30b. Preferably, front wall 30a and side walls 30c are also transparent, however, opaque side walls 30c and front walls 30a may be contemplated to obscure the head <NUM> of the user <NUM> from the outside.

In conclusion, the constraining means allow the device <NUM> to be locked, when necessary, to any transport structure, for example a stretcher, of the user.

The protective device <NUM> for protecting an operator from airborne infectious diseases according to the invention achieves important advantages.

In fact, the protective device <NUM> for protecting an operator from airborne infectious diseases always ensures a high visibility of the head of the user to allow the operator to carry out interventions with great efficiency since the crossing point 2a does not obstruct the view of the operator as, unfortunately, happens with all similar solutions of the known technology.

Moreover, device <NUM> increases the possibility of movement of the operator's limbs, allowing him to make wider and more precise movements.

In fact, the conformation of the second accesses is such as to allow the adoption of any posture both of the operator as a whole and of the individual limbs.

Claim 1:
Protective device (<NUM>) for protecting an operator from airborne infectious diseases comprising:
- a frame (<NUM>) having an approximate shape of a pavilion vault with a quadrangular base made of at least two rods (<NUM>) mutually crossed at one crossing point (2a),
- a cover (<NUM>) supported by said frame (<NUM>) and defining walls (<NUM>) delimited by said rods (<NUM>), a flat bottom (<NUM>) subtended by said walls (<NUM>) and a chamber (<NUM>) delimited by said walls (<NUM>) and said bottom (<NUM>) for housing at least the head (<NUM>) of a user (<NUM>),
- said walls (<NUM>) comprising a front wall (30a) including at least a first access (<NUM>) capable of allowing said user (<NUM>) to insert said head (<NUM>) into said chamber (<NUM>), a transparent rear wall (30b) opposite to said front wall (30a) and side walls (30c), and said device (<NUM>) being characterized by
- said crossing point (2a) defines a projection point (2a') on said decentred bottom (<NUM>) and closer to said front wall (30a) than said rear wall (30b) so that said rear wall (30b) is more extended, increasing the visibility of said chamber (<NUM>) from the outside.