A protective cap configured to be worn by a surgeon over a helmet

Abstract

A protective cap (1) for use in surgery adapted to be worn in a sterile fashion by an operator over an instrumented helmet, the protective cap (1) comprising: a frontal field of view lens (3); and an enclosing body (10) secured to the field of view lens (3) configured to generally cover the operator's head and neck and upper chest, the enclosing body (10) including a filtering portion (2) for viral and bacterial agents.

Description

[Technical field]

[0001] TECHNICAL FIELD OF THEINVENTION FIELD OF THEINVENTION This invention relates to caps or hoods of the type used by medical personnel, particularly surgeons, in conjunction with protective helmets.

[0002] The cap or hood may be of the disposable type. [Background technology]

[0003] background As is known, current surgical procedures prescribe that the surgeon wears a protective helmet, generally an instrument helmet, over which a cap or hood is worn to protect the surgeon himself from infectious and biological agents of the patient. The cap covers the helmet and then the subject's head as well as part of the head and chest. The cap is supplied folded under sterile conditions and includes a viewing lens or transparency that is positioned in a dedicated opening in the helmet.

[0004] Over the cap, or better over the chest, a gown is then worn, generally of the disposable type.

[0005] The donning devices described above, as mentioned above, are intended to guarantee perfect external sterile conditions for the surgeon and are by their nature very complicated.

[0006] An example of the above type of system with improved wearability is described in WO 2021 / 099881 A1.

[0007] Despite the complexity of the proposed system, which includes multiple components worn together and at least partially overlapping, there remain significant challenges with respect to protecting the surgeon from viruses and bacteria that may be present in the surgical environment.

[0008] The same drawbacks arise in other applications of the above types of caps that are not necessarily medical applications, as well as with other operators who are not necessarily medical operators, for example in so-called "clean rooms" in laboratories and laboratories, where it may be appropriate to filter even the air exhaled by the operator before it is released back into the environment. Summary of the Invention [Problem to be solved by the invention]

[0009] Summary of the Invention The technical problem presented and solved by the present invention is therefore primarily that of providing a cap or hood of the above type that is able to improve the protection of the operator, and in particular the surgeon, from viruses and bacteria. [Means for solving the problem]

[0010] Such a problem is solved by a cap or hood according to claim 1.

[0011] Preferred features of the invention are set out in the dependent claims.

[0012] In the context of this specification, terms such as "sagittal," "frontal," "anterior," "lateral," "posterior," "upper," "lower," and derivatives are assigned to elements of the cap or their locations and refer to the wearing configuration of the cap itself in relation to the anatomical definition of the body of the practitioner who will wear it.

[0013] In general terms, the cap of the present invention is of a type suitable for covering entirely or nearly entirely the head, neck and upper chest of the practitioner.

[0014] According to the invention, the cap includes a filter located at the rear of the head and configured to block viral and bacterial agents, preferably configured to cover one or more air inlet ports of a helmet worn under the cap in use.

[0015] In particular, the helmet used with the cap of the present invention includes means for ventilating its internal environment, suitable for providing a "fresh" air flow at the operator's face and for allowing optimal air exchange within said environment. Such a helmet with ventilation means, in combination with the above-mentioned filtering part of the cap, can improve the operator's health and reduce the risk of infection, in favor of the operator's health in general and his own performance.

[0016] Other advantages, features and modes of use of the invention will become apparent from the following detailed description of embodiments thereof, given by way of example and not of limitation.

[0017] Brief explanation of the figure Reference is made to the figures of the accompanying drawings. [Brief description of the drawings]

[0018] [Figure 1A] 1 shows a schematic side view of a preferred embodiment of a cap according to the present invention. [Figure 1B] 1 shows a schematic front view of a preferred embodiment of a cap according to the present invention; [Figure 1C] 1 shows a schematic rear view of a preferred embodiment of a cap according to the present invention. [Diagram 2] FIG. 2 shows a side perspective view of a surgical helmet for use with the cap of the present invention, illustrating by arrows the airflow through the helmet and the cap itself. [Diagram 3] 3 shows a front perspective view of an operator wearing the helmet of FIG. 2. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 1A, 1B and 1C, a cap according to a preferred embodiment of the present invention is indicated generally at 1. Cap 1 is adapted to be worn by a surgeon during surgery in an operating theatre.

[0020] Variations of the application may be used in other situations, particularly where sterile clothing or harnesses are required, for example in laboratory clean rooms.

[0021] The cap 1 is also adapted to be sterilized and provided sterile folded within the package in a manner known in the art.

[0022] In this embodiment, the cap 1 is of a disposable type.

[0023] The cap 1 is intended to be worn over an instrumented surgical helmet, shown diagrammatically in FIG. 2 and designated herein as 100.

[0024] The cap 1 is generally symmetrical about its own longitudinal axis L, which corresponds substantially to the sagittal plane trace of the practitioner wearing it in use.

[0025] On the cap 1, an inner surface or side 15 and an outer surface or side 16 can be identified and are defined as such because the first surface 15 faces towards or is in direct contact with the wearer's body after donning, whereas the second surface 16 actually faces towards the external environment.

[0026] The cap is configured to generally cover the head, neck and upper chest of the practitioner wearing it, and to cover it with its own encircling body 10. The body 10 is made of a flexible material, preferably fabric.

[0027] The body 10 is fixed in its front opening 18 over the peripheral area of ​​the front field lens 3. The front field lens 3 is positioned, in use, to extend over at least the surgeon's eye, and preferably over a large portion of the subject's face, so as to ensure a sufficient and comfortable area of ​​vision during the surgical procedure.

[0028] Referring also to FIG. 2, the field lens 3 may have means for connecting to the surgical helmet 100, in particular coupling means 31, for example in the form of a through hole, suitable for engaging with a corresponding element of the surgical helmet 100, for example a hook-like appendage 103.

[0029] The body 10 of the cap 1 is advantageously implemented in a single piece, with a front part 11 and a rear part 12 identified thereon, which may be connected and integrated by means of two opposing side parts 13 and 14.

[0030] The front portion 11 may have a bib-like shaped lower appendage 111 that extends over the surgeon's chest in use. Preferably, the lower appendage 111 has a rectangular or polygonal shape (such as the example shown in FIG. 1B) or a shape with arcuate edges. The remaining periphery of the body 10, specifically the back portion 12 and side portions 13, 14, have a generally rounded or arcuate contour.

[0031] The bib-like appendage 111 may define a greater longitudinal extension on the front portion 11 than on the back portion 12 .

[0032] On the rear portion 12 of the body 10, the respective longitudinal ends of the first and second transverse tie rods, 41 and 42 respectively, are fixed and positioned on opposite sides with respect to the longitudinal axis L, i.e., the sagittal plane of the surgeon. The tie rods 41 and 42 are configured to be manually tied to the body 10 on the front side for fixing in position near the surgeon's body.

[0033] Overall, of the elements described in this specification, cap 1 may be implemented in accordance with the teachings of WO 2021 / 099881 A1.

[0034] The body 10 comprises a portion 2 made of a filter fabric suitable for blocking the entry of viral and bacterial agents. The filter portion 2 is located in the upper and mid-rear portion of the body itself, i.e. in the portion that, in use, is actually located on the operator's head in its apex and mid-rear position. In the illustrated example, the filter portion 2 has a front edge 20 that is located on the horizontal centerline of the head when related to the raphe or weld line of the vertical centerline of the body 10. On the dorsal side, the filter portion 2 has an arched contour 21 that covers the top of the skull. In the illustrated example, such a dorsal portion of the filter portion 2 bears a shape that converges to the center and then tapers downwards.

[0035] The enveloping body 10 may, for example, in all its parts, except for the filtering section 2, be implemented with a polypropylene three-ply laminate made of four layers of material having filtering and ventilation effect, for example consisting of two outer layers of spunbond polypropylene and one inner layer consisting of a blend of filtering synthetic fabric stretched over a layer of polypropylene having a carrier effect.

[0036] Specifically, in a variant of the embodiment, the material having four layers of the filtration section 2 has a weight of 115 g / m 2 It is a composite synthetic fabric and spunbond polypropylene, cover web spunbond polypropylene 15g / m 2 , composite synthetic fabric 70g / m 2 , Carrier: Spunbond polypropylene 15g / m 2 , Cover web spunbond polypropylene 15g / m 2 The present invention includes or consists of:

[0037] In a preferred embodiment, the material of the remaining portion of the envelope body 10 is a nonwoven material, specifically thinner and lighter (68 g / m 2 ), which may advantageously consist of or include a nonwoven material which may be defined as a breathable viral barrier.

[0038] Advantageously, in a preferred embodiment, the filtering portion 2 is joined to the remaining periphery of the enveloping body 10 by ultrasonic welding, without the need for stitching.

[0039] Ultrasonic bonding entails several advantages over welding and other bonding methods, since it allows the connection and creation of one-piece dissimilar materials without the use of threads or adhesives, and in particular without piercing the tissue with needles, which would obviously greatly compromise its overall ability of barrier effect against bacteria and viruses. Through this bonding technique, it is possible to minimize the thermal distortion of the material of the nonwoven or generally the remaining part of the enveloping body involved in the bonding, thus preserving the flexibility and specificity of the material itself.

[0040] Advantageously, an ultrasonic welding machine can be used that is equipped with a special roller with a pattern and a rotating sonotrode with selected adjustments regarding pressure and then friction.

[0041] In an exemplary, non-limiting embodiment, the characteristics of the filtration material are as follows:

[0042] Effectiveness of filtration performance NaCl penetration at 32 LPM <6.00% NaCl 0.1 micron particle size tested according to TSI8130. NaCl efficacy at 32 LPM >94.00% NaCl 0.1 micron particle size tested according to TSI8130. Pressure reduction at 32 LPM <0.7 mm H2O NaCl 0.1 micron particle size tested per TSI8130. BFE average efficacy (40CM2) 99.90% Reference study #1311706-S01 study protocol (STP0009REV14). VFE average efficacy (40CM2) 99.53% Reference study #1311707-S01 study protocol (STP0010REV15). Breathability >275CFM Tested according to ASTM standard ASTM D737.

[0043] The standard procedures for testing viral filtration effectiveness have been modified to be more stringent than in normal use, but testing is performed in accordance with US FDA Good Manufacturing Practice (GMP) regulations 21 CFR parts 210, 211 and 820. Target flow rate: 30 LPM (liters per minute) Test area: approx. 40cm2 Test side: Both sides Critical levels: 6.2×106 PFU for VFE and 2.2×106 CFU for BFE MPS: approx. 2,9μm

[0044] As far as surgical helmet 100 is concerned, this is illustrated diagrammatically in FIGS.

[0045] The helmet 100 has a helmet body 102 substantially in the form of a helmet adapted to encircle the head of a practitioner.

[0046] The body 102 has a support structure mainly implemented by a sagittal upright body 121 having a curved shape that substantially follows the contour of the surgeon's head according to the sagittal plane of the surgeon's head.

[0047] The sagittal upright 121 is joined on its front side to an additional front structural element 124, shaped substantially like a polygonal mask, in particular substantially rectangular. The front mask 124 defines a central component adapted to be reclosed by a transparent viewing element 3 integral to the cap 1.

[0048] The helmet 100 further includes forced air circulation means, generally indicated at 103, within an environment, indicated at 120, which accommodates the surgeon's head and is defined by the body 102 of the helmet, the lens 3 and the cap 1 and is closed from the outside.

[0049] In the present example, the forced air circulation means 103 comprise first and second ventilation means 131 and 132, respectively, typically implemented by means of axial or radial fans of a type known per se. The means 131 and 132 are housed within the interior and rear components of the sagittal upright 121. Such first and second ventilation means 131 and 132 are, for example, battery powered.

[0050] The first ventilation means 131 is a means for admitting "fresh" air into the environment 120 and for this purpose comprises an intake 130 .

[0051] The second ventilation means 132 are instead means for drawing in exhaust air from the environment 120, which can then exhaust said exhaust air from such environment and subsequently reduce its CO2 content. For this purpose, the means 132 comprise an air outlet 133. Such flow in and out through the openings 130 and 133 is illustrated by arrows in FIG.

[0052] On the outside of the upright 121 , the forced circulation means 103 may provide a flange for connection with the cap 1 .

[0053] Preferably, means are provided for controlling the flow and / or speed of the air admitted and / or expelled by the ventilation means 131 and 132. In the present example, such control means are integrated into a control unit in front of the ventilation means 131 and 132, preferably located at the top of the upright 121.

[0054] Advantageously, the control unit and / or the ventilation means, if of the non-contact type, comprise means for activating the ventilation means.

[0055] 2 and 3 using arrows, in order to promote forced air circulation within the environment 120, the support structure elements 121 preferably have a tubular shape in the sense that they are hollow inside and communicate with the environment 120 by means of respective front openings or loop holes 150. In this way, the support elements 121 guide the air flow entering the environment 120, generated by the forced circulation means 103.

[0056] The hollow configuration of the uprights 121 also determines the considerable weight reduction of the helmet 100 .

[0057] The overall configuration obtained with the arrangement of the ventilation means 131 and 132 is then such that air is admitted into the environment 120 by the means 131, passes through the sagittal upright 121 and the front opening 150 of the sagittal upright 121, and is thus conveyed towards the frontal area defined by the mask 124. As illustrated by the arrows in Figures 2 and 3, a "fresh" air flow containing sufficient oxygen surrounds the operator's face from top to bottom in its center, and is called back laterally of the face itself at the skin and chin towards the ventilation means 132, providing towards the outside a flow of exhaust air mainly exhaled according to the operator's breathing.

[0058] Suction through the means 132 occurs using suction generated by the means 132 at the dorsal portion of the sagittal body 121. As previously described, air is conveyed laterally past the operator's face and out of the environment 120.

[0059] Placing the opening or loop hole 150 in the sagittal upright 121 directly on the lens 3 allows for controlled air intake directly on the lens 3, effectively reducing fogging thereof.

[0060] The filtering portion 2 of the main body 10 of the cap 1 is positioned at the suction port 130 of the first ventilation means 131 during use.

[0061] Preferably, the helmet 100 also comprises means for wearing the body 102 and in particular the flexible structure 106 shaped substantially like a cover on the operator's head. It is implemented by two transverse bands 161 and 162 and a sagittal band 163 placed under the upright body 121.

[0062] Structure 106 further provides an azimuth adjustment element 164 having sagittal teeth or equivalent engagement means, for example by engaging corresponding peripheral teeth of sagittal band 163, thereby allowing the sagittal (azimuth) position of body 102 to be adjusted relative to the surgeon's head.

[0063] The structure 106 further includes a perimeter adjustment element 165 including intersecting or peripheral teeth that engage corresponding peripheral teeth of the bands 161 and 162. In this manner, the extension of the base perimeter can be adjusted, allowing the helmet 100 to be adapted to the particular anthropometry of the subject who will actually wear it.

[0064] Such dual ability to adjust the positioning of the helmet 100 on the head increases the stability of the helmet itself when in use, greatly enhancing comfort for the practitioner.

[0065] Advantageously, both circumferential and azimuthal adjustment may be obtained by a single knob 166 or equivalent adjustment means located at the rear of the head in use.

[0066] The structure 106 is integral with the body 102 at selected locations.

[0067] Overall, the helmet may be implemented by the devices described in WO 2017 / 120562 A2 or WO 2012 / 111030 A1.

[0068] Preferably, removable connection means are provided to restrain the body 102 of the helmet to the cap 1. Advantageously, and as already mentioned above, in the present example, such additional means are based on a form of coupling between a connection flange of the body 102 and a corresponding complementary element associated with the cap 1.

[0069] It will be appreciated that each of the above-described embodiments, variations and configurations allows for optimization of fresh air delivery and exhaust air evacuation in the environment housing the surgeon's head, with important benefits relating to the comfort of the surgeon himself.

[0070] The present invention has been described above with reference to preferred embodiments thereof, it is intended that other embodiments belonging to the same inventive core may exist as defined by the scope of protection of the claims reported below.

Claims

1. A protective cap (1) configured to be worn by an operator over a helmet (100), in particular in an operating room or clean room, comprising: a front view lens (3) configured to be positioned at least over the eye of the surgeon in use; an enveloping body (10) secured to the field lens (3) at its peripheral region and configured to completely cover the surgeon's head, neck and upper chest; a protective cap (1) comprising an enclosing body (10) comprising a front part (11) and a rear part (12) connected and integrated by two opposite side parts (13, 14), the main body (10) further includes a filtering section (2) configured to block viral and bacterial agents, the filtering section (2) being disposed at an upper and middle rear section of the main body (10) that is placed on the surgeon's skull during use; The filtering portion (2) is joined to the periphery of the main body (10) by ultrasonic welding. Protective cap (1).

2. 2. A protective cap (1) according to claim 1, wherein the front part (11) has a lower appendage (111) shaped like a bib that extends over the surgeon's chest in use.

3. 2. The protective cap (1) according to claim 1, comprising a first lateral tie rod (41) and a second lateral tie rod (42), each of which is fixed at its respective end on the enveloping body (10), the first tie rod (41) and the second tie rod (42) being arranged on opposite sides of the longitudinal axis (L) of the cap (1) and configured to be wrapped around the chest and connected to each other, in particular tied, when the cap (1) is worn.

4. 2. The protective cap (1) according to claim 1, wherein the filtering portion (2) comprises a rear portion having a downwardly tapered shape.

5. 2. The protective cap (1) according to claim 1, wherein the enveloping body (10), except for the filtering portion (2), is made of a polypropylene three-layer laminate.

6. 2. Protective cap (1) according to claim 1, wherein the filtering part (2) is made of a single or multi-layer filtering material suitable to ensure filtering of more than 99% of viruses and bacteria.

7. 2. A protective cap (1) according to claim 1, wherein the field lens (3) has connection means, in particular coupling means (31), for connecting to a surgical helmet (100).

8. 2. The protective cap (1) according to claim 1, which is sterilizable or is supplied sterile in the package.

9. 2. A protective cap (1) according to claim 1, which is of the disposable type.

10. 10. An assembly comprising a protective cap (1) according to any one of claims 1 to 9 and a surgical helmet (100) connectable to said field lens (3), said protective cap (1) being adapted to be worn on top of said surgical helmet (100).

11. 11. The assembly according to claim 10, wherein the helmet (100) includes forced air circulation means having ventilation means (131) configured to draw in outside air, and the filtering part (2) of the cap (1) is configured to be placed over the intake port (130) of the ventilation means (131) in use.

12. An assembly comprising a protective cap (1) according to any one of claims 1 to 9 and a gown that can be worn over the lower part of said enveloping body (10).

13. 11. The assembly of claim 10 supplied as a kit.

14. The assembly of claim 12 supplied as a kit.

15. A sterile package comprising a cover and a sterile protective cap (1) according to any one of claims 1 to 9, wherein the protective cap (1) is accommodated in the cover in a folded form.

Images