A protective shield for medical use

Abstract

A protective shield (1) for surgical use, adapted to be worn in a sterile form by an operator on an instrumented helmet, the shield (1) comprising: a front visual lens (20); an encapsulating body (10) fixed to the visual lens (20), configured to completely cover the head and neck of the operator and the upper part of the chest. The encapsulating body (10) comprises a front part (11) and a rear part (12) connected and made integral by two opposite sides (13, 14), wherein the rear part (12) has a pair of lateral cords (31, 32), the lateral cords being arranged on opposite sides with respect to the sagittal plane of the operator and extending laterally outwards in use, the cords being grasped by the operator during wearing to easily remove the shield.

Description

Technical Field

[0001] The present invention relates to a shield of the type associated with a protective helmet for use by healthcare operators, in particular surgeons, and which is generally a disposable shield. Background Art

[0002] As is known, current surgical procedures require surgeons to wear protective, generally instrumented helmets, and to wear on the helmet a generally disposable shield. The latter covers the helmet and then the head of the subject, as well as part of the neck and chest. Over the shield, or better still over its chest part, a gown of generally disposable type is then put on.

[0003] The purpose of the above-mentioned wearing devices is to ensure completely aseptic conditions outside the operating surgeon, and due to their nature, the above-mentioned wearing devices lead to considerable complexity, especially associated with the way of wearing. In fact, the shield is provided folded under aseptic conditions and it includes a lens to be positioned at an appropriate dedicated opening. When the rear part of the shield is undone so that the latter covers the back of the neck and the shoulders of the subject, there is a risk that the outside of the shield itself is touched by the surgeon himself / herself or by an operator helping him / her under non-aseptic conditions. For example, this part can come into contact with the arm of the surgeon or other parts of the body not protected by sterile gloves. This actually invalidates the donning by the surgeon, albeit in an imperceptible and thus irreparable way.

[0004] Moreover, when the surgeon dons it autonomously, especially during the phase in which a part of it needs to be flipped to cover the nape and the back, the donning of the shield is extremely uncomfortable. This process involves unnatural movements of the arms, which actually cause discomfort to the surgeon himself / herself during the phase in which he / she should be resting and concentrating before the operation.

[0005] Even with other applications (not necessarily medical) of shields of the above-mentioned type, and other operators (not necessarily healthcare operators), the same drawbacks occur, for example in the so-called "clean rooms" of research and laboratories. Summary of the Invention

[0006] The technical problem posed and solved by the present invention is mainly to provide a protective shield that allows the drawbacks mentioned above with reference to the known art to be solved.

[0007] This problem is solved by a protective shield adapted to be worn in an aseptic form by an operator on a helmet in an operating room or in a clean room. The protective shield is supplied in a folded form and comprises: a front vision lens adapted to be positioned at least in front of the operator's eyes in use; an encapsulating body fixed to the vision lens at the peripheral region thereof and configured to entirely cover the operator's head, neck and upper part of the chest. The encapsulating body comprises a front part and a rear part connected and made integral by two opposite sides. It further comprises a first cord and a second cord, each of the first cord and the second cord being fixed at respective ends to the rear part of the encapsulating body. The first cord and the second cord are arranged on opposite sides with respect to the longitudinal axis of the shield. The first cord and the second cord are configured to be grasped by the operator during donning of the shield in order to unfold the rear part and cause it to cover the rear part of the operator's head, neck and chest. The first cord and the second cord also have lengths such that they can be arranged around the chest at the end of donning of the shield and connected to each other at the front part of the encapsulating body, wherein the vision lens has connecting means to a surgical helmet; and wherein the folded form is such that the front part is folded onto the vision lens by multiple folds, the rear part undergoes multiple folds so as to rest in this configuration on the already folded front part, and the first cord and the second cord are folded by multiple and regular folds and rest on the already folded rear part.

[0008] Preferred features of the invention are set out below:

[0009] In some embodiments, the first cord and the second cord also have lengths such that they can be arranged around the chest at the end of donning of the shield and knotted to each other at the front part of the encapsulating body.

[0010] In some embodiments, the front part has a lower attachment shaped like a bib which extends over the operator's chest in use.

[0011] In some embodiments, the encapsulating body is made of fabric.

[0012] In some embodiments, the first cord and the second cord are each attached at the lower end part of the rear part.

[0013] In some embodiments, the first cord and the second cord are each in the form of a web having a limited thickness with respect to its longitudinal and transverse dimensions.

[0014] In some embodiments, the first cord and the second cord have a substantially rectangular planar configuration.

[0015] In some embodiments, the first cord and the second cord are configured such that a distance is allowed to be maintained between the arm of the object and the body during wearing, sufficient to avoid contact between the outer side of the body itself and the arm of the operator who autonomously performs the wearing operation.

[0016] In some embodiments, each of the first cord and the second cord has a length included in the range of approximately 20 - 150 cm.

[0017] In some embodiments, the first cord and the second cord are made of fabric.

[0018] In some embodiments, the protective shield can be sterilized or supplied aseptically in the package.

[0019] In some embodiments, the protective shield is of the disposable type.

[0020] In some embodiments, the connecting means is a hook means.

[0021] In the context of the present specification, the terms "sagittal", "front", "frontal", "lateral", "rear", "upper", "lower" and derivatives are assigned to the shield element or its position, and refer to the worn configuration of the shield itself, even in relation to the anatomical definition of the body of the operator wearing it.

[0022] Generally, the shield of the present invention is of the type adapted to completely or almost completely cover the upper part of the head, neck and chest of the operator.

[0023] The shield of the present invention provides a pair of cords (or "chest straps") which are attached to the rear part of the shield covering the upper part of the head, neck and chest. The surgeon can grasp such cords with sterile gloves, and these cords allow him / her to autonomously and easily wear the shield by pulling the cords into position without the risk of contaminating its outer part.

[0024] The cords are configured such that a sufficient distance is allowed to be maintained between the arm of the object and the body of the shield during wearing so that no interference between the arm and the outer side of the shield itself is formed. Thus, the risk of contamination between the sterile outer part of the shield and the non-sterile body of the object is significantly reduced.

[0025] Advantageously, at the end of the wearing process, the same two cords can be knotted at the chest of the user or otherwise connected to each other. In this way, they hold the front, rear and side parts of the body of the shield in position, especially during the subsequent stage of wearing the gown.

[0026] Therefore, when the surgeon or generally the operator is fully donned and ready to perform the work he / she has to complete, the cords remain inside the donning piece, i.e., under the gown.

[0027] In other words, the design and positioning cords are intended to facilitate the donning process without contamination.

[0028] Other advantages, features, and modes of use of the present invention will be apparent from the following detailed description of embodiments of the invention, which are shown by way of example and not for purposes of limitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Reference will be made to the figures in the accompanying drawings, in which:

[0030] Figures 1A to 1B Front and side views, respectively, of a preferred embodiment of a shield according to the present invention are shown;

[0031] Figure 2 A side view showing a portion of the head, neck, and chest of an operator wearing a housing surgical helmet used with the shield of the present invention is shown;

[0032] Figure 3 Shows Figure 2 of an operator who is ready to don Figure 1A and Figure 1B a shield, the latter being provided in a folded form as if just removed from the packaging;

[0033] Figures 4A to 4G Each shows the operator in various stages of donning Figure 1A and Figure 1B a shield;

[0034] Figures 5A to 5E Each shows the operator in various stages of donning Figures 4A to 4G a shield in a donning manner according to a partial alternative to the donning manner in the foregoing Figure 1A and Figure 1B ;

[0035] Figures 6A to 6D Each shows the operator in various stages of donning Figure 1A and Figure 1B a shield (or a side view, for Figure 6C ), with respect to subsequent stages of the stages shown in Figures 4A - 4G or Figures 5A - 5E ;

[0036] Figures 7A to 7E Each shows the top view (or side view, for Figure 1A and Figure 1B ), of the shield being folded for the purpose of packaging the shield; Figure 7C ;

[0037] Figure 7F Shows Figure 1A and Figure 1B a schematic side view of the shield in its final folded configuration. Detailed Description

[0038] Referring Figure 1A and Figure 1B , the shield according to a preferred embodiment of the present invention is generally designated by 1 and is adapted to be worn by a surgeon during a surgical operation in an operating room.

[0039] Applicable variations may provide for use in other scenarios where especially sterile clothing or covers are required, such as clean rooms in laboratories.

[0040] The shield 1 is adapted to be sterilized and is provided folded in a packaging that is also sterile in a manner to be described below.

[0041] In this embodiment, the shield 1 is of the disposable type.

[0042] The shield 1 is for wearing on an instrumented surgical helmet, which is schematically shown in Figure 2 and designated herein by 4.

[0043] The shield 1 is generally symmetric with respect to its own longitudinal axis L, which in use substantially corresponds to the sagittal plane of the operator wearing the shield.

[0044] On the shield 1, an inner face or inner side 15 and an outer face or outer side 16 can be defined and identified, since after wearing the first is in direct contact with the body of the subject, while the second actually faces the external environment. The latter face is the face that must remain sterile even after wearing so as not to contaminate the operating environment.

[0045] The shield is configured to completely cover the head, neck and upper part of the chest of the operator wearing the shield, and this is achieved by its own encapsulating body 10, which is made of a flexible material and preferably of a fabric.

[0046] The body 10 is fixed at its own front opening 18 to the peripheral region 21 of the front vision lens 20, which in use is at least positioned at the eyes of the operator and preferably extends over the wide part of the face of the subject so as to ensure sufficient and comfortable vision during a surgical operation.

[0047] The vision lens 20 has connection means, in particular hook means 22 in the form of through holes, at the corresponding hooked attachments 41 of the surgical helmet 4.

[0048] The body 10 is advantageously implemented as a single piece. Thus, on this body, it is possible to identify a front part 11 and a rear part 12 that are connected by two opposite sides 13 and 14 and made in one piece.

[0049] The front part 11 has a lower attachment 111 shaped like a bib, which in use extends over the operator's chest. Preferably, it has a square shape, i.e., a polygonal shape, while the remaining peripheral edges of the body 10, especially at the rear part 12 and the sides 13, 14, have a generally circular or curved profile.

[0050] The bib-shaped attachment 111 determines a greater longitudinal extension of the front part 11 relative to the rear part 12.

[0051] The respective first longitudinal ends of a first lateral cord 31 and a second lateral cord 32, denoted 31 and 32 respectively, are fixed to the rear part 12 of the body 10, and these first longitudinal ends are arranged on opposite sides with respect to the longitudinal axis L (i.e., the sagittal plane of the operator).

[0052] Advantageously, the cords 31 and 32 are fixed to the body 10 at the lower peripheral edge of the rear part 12.

[0053] The side cords 31 and 32 extend laterally outside the rear part 12 in use and are configured to be grasped by the operator during the wearing of the shield 1 in order to unfasten the rear part 12 and to make it cover the back part of the head, neck, and chest, as will be briefly described. The cords 31 and 32 are configured to allow a distance to be maintained between the object's arm and the body of the shield during wearing, sufficient to avoid contact between the outer side of the body of the shield 1 and the arm of the operator who autonomously performs the wearing operation.

[0054] Advantageously, the cords 31 and 32 also have a length to surround the chest at the end of the wearing of the shield 1 and thus to be knotted to each other on the front part 11 of the body 10, for example on its bib-shaped part 111.

[0055] In a preferred embodiment variant, the length of each cord is in the range of about 20 - 150 cm.

[0056] In one embodiment, the cords 31 and 32 are each in the form of a web and have a limited thickness with respect to their own longitudinal and transverse dimensions. They can have a substantially rectangular planar shape.

[0057] The cords 31 and 32 can be made of the same material as the body 11, especially of fabric, or even of different materials, for example with respect to elastic properties.

[0058] Now reference will be made to Figures 3 to 6D the manner of wearing the shield 1.

[0059] As Figure 3As shown, the operator grasps the shield 1 in its folded form, typically as it is contained in the packaging. Usually, the operator touches the shield 1 with sterile gloves (not shown in the figures for simplicity). Usually, the face of the shield 1 that is exposed after folding is the inner face 15.

[0060] As Figure 4A Schematically shown, the operator hooks the visual lens 20 to the hook-shaped attachment 41 of the helmet 4 by connecting the entire shield 1 to the helmet itself.

[0061] As Figure 4B Shown, the shield is then rotated downward still in its folded form so that the visual lens 20 covers the front opening 42 of the helmet having the same shape and size.

[0062] At this time, as Figure 4C Shown, the operator can cause the shield 1 to start unfolding, i.e., opening, by allowing the cords 31 and 32 to hang downward.

[0063] As Figure 4D and Figure 4E Shown, the operator can grasp the bib-shaped portion 111 and pull it downward to cover the upper front part of the chest.

[0064] As Figure 4F and Figure 4G In the order shown, the operator then grasps the cords 31 and 32 and, by a simple movement of separating and rotating the arms backward, also unfolds the rear part 12 and the side parts 13 and 14 of the shield 1 to completely cover the body of the subject.

[0065] Figures 5A to 5E An alternative way of wearing as shown in the order of... provides that the operator first unfolds the side parts 13, 14 and the rear part 12, and then unfolds the front parts 11, 111.

[0066] Regardless of which of these two ways is adopted, the wearing can be completed in the order of stages shown, where it can be seen that the operator grasps the cords 31 and 32 and introduces them in a rear-to-front direction until tying them in a knot on the front part 11 of the main body 10. Figures 6A to 6D Shown, the operator then grasps the cords 31 and 32 and introduces them in a rear-to-front direction until tying them in a knot on the front part 11 of the main body 10.

[0067] Then, the operator's donning can end as follows, i.e., putting on a sterile gown that covers the lower part of the shield, especially the shoulders and chest of the subject, and then re-closing the bib-shaped attachment 111 and the cords 31 and 32 at least at the part knotted on the front side.

[0068] The shield of the present invention can even be provided as a component or a kit, which has a surgical helmet similar to the above-mentioned one and / or has a gown that can be worn on the lower part of the main body of the shield itself.

[0069] The present invention even provides a method of wearing a protective shield. Referring to the above embodiments, the method provides the following main steps:

[0070] ■ Connect the vision lens 20 to the surgical helmet 4 worn by the operator, in particular by hooking the opening 22 of the vision lens to the attachment 41 of the surgical helmet 4;

[0071] ■ Grasp the ropes 31, 32, separate them and apply a traction force in the backward direction so as to unfasten the rear part 12 of the encapsulating body 10 on the head, neck and chest;

[0072] ■ Wind the ropes 31, 32 around the chest in the direction from back to front, and connect, in particular tie, the respective longitudinal ends at the front part 11 of the shield 10 covering the chest.

[0073] Before or after unfastening the rear part 12, the front part 11 of the encapsulating body 10 can be pulled downwards.

[0074] As mentioned above, the shield 1 is preferably provided in a folded form, advantageously in a sterile form, in a package which is opened by the surgeon or other operator during use (wearing).

[0075] Figures 7A to 7F shows the different steps for folding the shield 1 during packaging of the shield or anyway for storage and / or transport purposes.

[0076] The shield 1 is placed on a working plane, where the lens 20 abuts on the working plane. The shield is initially in an unfolded configuration, preferably in a turned-over state, i.e., the inner face 15 faces outwards.

[0077] First, as Figure 7A shown, the front part 11 of the body 10 is folded over the lens 20, where it is folded two or three times.

[0078] As Figure 7B shown, then, the rear part 12 undergoes five or six folds so as to abut in this configuration on the already folded front part 11, Figure 7C This folding process of the rear part 12 is also involved by showing a side view of the shield 1.

[0079] As Figure 7D shown, then, the ropes 31 and 32 are folded in multiple and regular folds and abut on the already folded rear part 12.

[0080] Finally, as Figure 7E shown, by allowing a compact configuration to be obtained, and in the case of the minimum size of the shield, the protruding outer side edges and the bib-like attachment 111 are folded over the remaining part of the shield 1.

[0081] The present invention has been described with reference to preferred embodiments thereof. This means that other embodiments may exist which belong to the core of its invention, as defined by the scope of protection of the claims reported below.

[0082] Reference numerals of the drawings

[0083] 1 - Shield

[0084] L - Longitudinal axis of the shield

[0085] 15 - Inner surface of the shield

[0086] 16 - Outer surface of the shield

[0087] 20 - Visual lens of the shield

[0088] 21 - Peripheral area of the visual lens

[0089] 22 - Hooking means of the visual lens

[0090] 10 - Enclosing body of the shield

[0091] 11 - Front part of the enclosing body

[0092] 111 - Apron - like attachment of the front part

[0093] 12 - Rear part of the enclosing body

[0094] 13, 14 - Opposite side parts of the enclosing body

[0095] 18 - Front opening of the enclosing body

[0096] 31, 32 - Side cords of the shield

[0097] 4 - Surgical helmet

[0098] 41 - Hook - like attachment of the helmet

[0099] 42 - Front opening of the helmet

Claims

1. A protective shield (1) adapted to be worn by an operator in a sterile form on a helmet in an operating room or in a clean room, the protective shield (1) being supplied in a folded form and comprising: ■ A front visual lens (20), which is adapted to be positioned at least in front of the operator's eyes during use, ■ An enclosing body (10), which is fixed to the visual lens (20) at the peripheral area (21) of the visual lens and is configured to completely cover the upper parts of the operator's head, neck and chest, The enclosing body (10) includes a front part (11) and a rear part (12) which are connected and made integral by two opposite sides (13, 14), characterized in that it further comprises ■ A first cord (31) and a second cord (32), each of the first cord and the second cord being fixed at its respective end to the rear part (12) of the enclosing body (10), the first cord (31) and the second cord (32) being arranged on opposite sides with respect to the longitudinal axis (L) of the shield, The first cord (31) and the second cord (32) are configured to be grasped by the operator during the wearing of the shield (1) in order to unfold the rear part (12) and cause it to cover the rear parts of the operator's head, neck and chest, The first cord (31) and the second cord (32) also have lengths such that they can be arranged around the chest at the end of the wearing of the shield (1) and connected to each other at the front part (11) of the enclosing body (10), wherein the visual lens (20) has connection means to a surgical helmet (4); and wherein the folded form is such that the front part (11) is folded onto the visual lens (20) by multiple foldings, the rear part (12) undergoes multiple foldings in order to rest on the already folded front part (11) in this configuration, and the first cord (31) and the second cord (32) are folded by multiple and regular foldings and rest on the already folded rear part (12).

2. The protective shield (1) according to claim 1, wherein the first cord (31) and the second cord (32) also have lengths such that they can be arranged around the chest at the end of the wearing of the shield (1) and knotted to each other at the front part (11) of the enclosing body (10).

3. The protective shield (1) according to claim 1, wherein the front part (11) has a lower attachment (111) shaped like a bib, the lower attachment extending over the operator's chest during use.

4. The protective shield (1) according to any one of claims 1 to 3, wherein the enclosing body (10) is made of fabric.

5. The protective shield (1) according to any one of claims 1 to 3, wherein the first cord (31) and the second cord (32) are each attached at the lower end part of the rear part (12).

6. The protective shield (1) according to any one of claims 1 to 3, wherein the first cord (31) and the second cord (32) are each in the form of a web and have a limited thickness with respect to their longitudinal and transverse dimensions.

7. The protective shield (1) according to claim 6, wherein the first cord (31) and the second cord (32) have a substantially rectangular planar configuration.

8. The protective shield (1) according to any one of claims 1 to 3, wherein the first cord (31) and the second cord (32) are configured such that a distance is allowed to be maintained between the object's arm and the body (10) during wearing, sufficient to avoid contact between the outer side of the body (10) itself and the arm of an operator who autonomously performs the wearing operation.

9. The protective shield (1) according to any one of claims 1 to 3, wherein each of the first cord (31) and the second cord (32) has a length included in the range of 20 - 150 cm.

10. The protective shield (1) according to any one of claims 1 to 3, wherein the first cord (31) and the second cord (32) are made of fabric.

11. The protective shield (1) according to any one of claims 1 to 3, which can be sterilized or supplied aseptically in a package.

12. The protective shield (1) according to any one of claims 1 to 3, which is of a disposable type.

13. The protective shield (1) according to any one of claims 1 to 3, wherein the connecting means is a hook means (22).

14. An assembly comprising the protective shield (1) according to any one of claims 1 to 13 and a surgical helmet (4) connectable to the visual lens (20), wherein the protective shield (1) is adapted to be worn on the surgical helmet (4).

15. An assembly comprising the protective shield (1) according to any one of claims 1 to 13 and a gown wearable on the lower part of the encapsulating body (10).

16. The assembly according to claim 14 or 15, which is supplied in the form of a kit.

17. A sterile package, comprising a winding portion and the sterile protective shield (1) according to any one of claims 1 to 13, wherein, The protective shield (1) is accommodated in a folded form in a housing.

18. The sterile package according to claim 17, wherein the front part (11) is directly folded over the visual lens (20), the rear part (12) is directly folded over the front part (11), and the first cord (31) and the second cord (32) are folded over the rear part (12).

19. A method for wearing the protective shield (1) according to any one of claims 1 to 13, the method providing the following steps: (a) Connect the visual lens (20) to a surgical helmet (4) worn by an operator by hooking the opening of the visual lens (20) onto an attachment (41) of the surgical helmet (4); (b) Grasp the first cord (31) and the second cord (32), separate them and apply a traction force in the backward direction so as to unwind the rear part (12) of the encapsulating body (10) over the head, neck and chest; (c) Wind the cords (31, 32) in a direction from the back to the front around the chest and connect the respective longitudinal ends at the front part (11) of the body (10).

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