Surgical helmet and hood
Patent Information
- Application Number
- EP2024711270
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-03-07
- Filing Date
- 2024-02-20
- Publication Date
- 2026-01-14
AI Technical Summary
Current surgical helmet and hood systems fail to adequately ventilate the surgeon's head, leading to CO2 accumulation and lens fogging, and provide a limited visual field, causing discomfort and claustrophobia during prolonged medical interventions.
A surgical helmet with onboard, self-contained ventilation means and a transparent lens with extended connection points to the hard hat frame, allowing improved air flow and increased visual field, along with a hood that covers the head, neck, and shoulders, providing additional protection and comfort.
The solution effectively reduces CO2 accumulation, prevents lens fogging, and enhances the surgeon's visual field and comfort by improving air circulation and providing a wider, unobstructed view, thus maintaining concentration and skill during long surgical procedures.
Smart Images

Figure IB2024051597_12092024_PF_FP_ABST
Abstract
Description
[0001] SURGICAL HELMET AND HOOD
[0002] DESCRIPTION
[0003] Field of the invention
[0004] The present invention relates to an individual protection assembly adapted to be worn by an healthcare worker, in particular a surgeon, during a medical intervention, especially in operating room.
[0005] In its most general sense, the protection assembly comprises a hard hat, or helmet, and a toga or hood, the latter in case at least partially disposable. The toga or hood is configured to be put on the helmet, that is worn over it.
[0006] Background of the invention
[0007] Over the last twenty years assemblies for the protection of an healthcare worker’ head and face have become very common, based on an instrumented hard hat, or helmet, to be worn during a surgical operation. Traditionally, such assemblies are mainly formed indeed by a helmet, a hood or toga worn over the hard hat to cover also the operator’s neck and shoulders and in case a protective gown in turn worn over the thoracic portion of the hood or toga.
[0008] The hood includes a transparent visor, or lens, acting as protective visor, in particular splash guards and vapours. The visor is constrained to the hood and the hard hat and indeed allows the surgeon the visual inspection of the operating environment.
[0009] These systems are used especially in the orthopaedic surgery, with particular reference to the interventions for the implantation of knee and hip prostheses, wherein drills equipped with reamers and saws are used. In this sense, the above-described protection assembly creates a sterile barrier between the surgeon and the patient. The healthcare worker then is protected from the patient’s biological material and from vapours and gases of the operating environment. Moreover, the above-mentioned assembly offers a valid protection even for the patient with respect to contaminations coming from the surgeon and the other healthcare workers, since it prevents hair, dandruff and sweat droplets from falling towards the operating field and then the possibility of infecting wounds.
[0010] The most advanced hard hat models comprise motorized ventilation means for the circulation and exchange of air inside the environment which houses the surgeon’s head. Such air circulation counteracts sweating and helps to keep refrigerated the space of the face chamber, in this way by increasing the operator’s comfort level. Moreover, the air circulation offers also a valid protection against the so-called “aerosol effect” of particles contaminated by viruses.
[0011] The above-described known protection systems have some drawbacks.
[0012] First of all, the ventilation of the environment which houses the surgeon’s head can be optimized. In fact, the known systems sometimes do not succeed in avoiding an accumulation of carbon dioxide (CO2) inside the environment itself and / or do not counteract effectively the lens fogging phenomenon, the latter linked especially to the breathing of the healthcare worker.
[0013] In fact, it is to be noted that the hood or toga associated to the helmet “close” the environment at the neck level, not allowing an adequate evacuation of the CO2 under the gown. Besides, the field evolution leads to the use of repellent materials, in particular polypropylene materials, to implement the toga or hood, which prevent perspiration.
[0014] Over the time - considering that, for example, an intervention of hip or knee prosthesis can last up to several hours - the above-mentioned drawbacks can reveal to be critical for the comfort, concentration and skill of the surgeon. In particular, the above-mentioned accumulation of CO2 can be source of discomfort.
[0015] Moreover, in the known systems the hood-lens group is kept in position on the helmet by a connection, for example of Velcro® type, between the peripheral edge of the lens itself and a frame of the hard hat mount. However, the Inventors have noted that the current configurations can be unable to allow an adequate visual field to the surgeon, and then a complete inspection of the operating environment. To this the fact is added that the environment which houses the surgeon’s head, as currently confined by the hood, is however limited and it can produce, especially for prolonged interventions, a claustrophobic effect.
[0016] The same drawbacks occur even in relation to other applications of the protection assembly of the above-mentioned type or of the related single components, not necessarily medical applications, and other operators, not necessarily healthcare workers, for example in the so-called “clean rooms" of the research and experimentation laboratories.
[0017] Summary of the invention
[0018] Therefore, the technical problem placed and solved by the present invention is to provide a protection assembly wearable by an healthcare worker during a medical intervention, in particular a surgical intervention, allowing to obviate the drawbacks mentioned above with reference to the known art.
[0019] Such problem is solved by a protection device configured like a helmet, or hard hat, according to claim 1 , by a protective hood or toga for use with a medical helmet according to claim 11 and by an assembly including said helmet and toga.
[0020] The terms “hard hat” and “helmet” are herein used as synonyms.
[0021] Likewise, the terms “hood” and “toga” are meant to designate a medical garment which covers at least the head, the neck and partially the shoulders.
[0022] As usual in the field, hereinafter the terms commonly used to identify the configuration of the patient body in anatomical position - in particular the planes and the sagittal, front and transversal directions - for the definition of the structural features of the protection assembly will be referred to. Such features are then referred, as common in the field, to the arrangement worn by the assembly itself.
[0023] The surgical helmet comprises onboard, that is self-contained and self-sufficient, ventilation means which then do not require external power supply or connection to air suction or introduction means of the operating room.
[0024] Such ventilation means comprises a suction unit arranged on an apical region of the hard hat configured to be worn indeed at the upper portion of the skull. Said suction unit is suitable to produce an air flow developing from below upwards, then by removing the exhaust air at the ocular region of the operator. Such air flow then rises from the nose or chin towards the forehead. With reference to the anatomical landmarks consolidated in the field for the definition of the structural configurations of wearable devices, the flow direction is substantially sagittal, in caudo-cranial direction.
[0025] Independently or in combination with the above-mentioned preferred features of the hard hat, the invention provides a transparent lens, viewer or visor, associated or which can be associated to a toga or hood for medical use. Such lens has removable connection means to a front frame of the hard hat mount, arranged bilaterally on the lens itself, in a transversally intermediate position. In other words, the lens has a higher latero-lateral, or antero-posterior, extension than that of the known lenses. In fact, the fact of providing means for the connection to the hard hat in intermediate position on the lens allows the latter to have, for each side, an additional portion which indeed extends in a latero-lateral direction posteriorly with respect to the frame of the hard hat.
[0026] This allows to increase the visual field of the surgeon in latero-lateral, that is antero- posterior, direction by improving the inspection of the operating environment and the perception of brightness and by also reducing the discomfort linked to the confinement of the head inside the hood. Moreover, the lens additional portion, which can extend as far as the surgeon’s ears, provides an additional rigid or half-rigid protection for the head and the neck of the operator herself / himself clearly higher than the one associated to the presence of the hood or toga, which are made of fabric or however yieldable material. This can result extremely useful, for example, for complex interventions in which the surgeon has to operate in strict proximity to the patient’s body, even to the body districts of the latter, for example a leg, in contact to or rested upon her / his shoulders.
[0027] Other advantages, features and use modes of the present invention will result evident from the following detailed description of some embodiments, shown by way of example and not for limitative purposes.
[0028] Brief description of figures
[0029] The figures of the enclosed drawings will be referred to, wherein:
[0030] ■ Figure 1 shows a front perspective view of a preferred embodiment of a medical protection assembly according to the present invention, which for sake of simplicity does not represent a toga or hood, but only a transparent lens thereof;
[0031] ■ Figures 2A and 2B relate in a purely exemplifying way to a mode for wearing an assembly of toga or hood over a medical helmet, by showing a front and a lateral view thereof, respectively.
[0032] Detailed description of preferred embodiments
[0033] Figure 1 shows a helmet or protection hard hat 100 adapted to be worn by a healthcare worker, in particular in a surgical intervention. The helmet 100 is represented connected to a transparent lens 20 of a toga or hood. For greater illustration clarity of the connection modes, an enveloping main body of the toga or hood was not represented.
[0034] By pure way of example, in order to understand the modes for wearing a toga or hood over the helmet 100, Figures 2A and 2B indeed show such toga or hood, designated with 1 . However, these last figures are to be considered purely exemplifying and show components of known type.
[0035] A preferred embodiment of the assembly helmet + toga or hood will be now described with reference to the above-mentioned figures.
[0036] It is to be meant that the helmet, toga or hood and the related transparent lens according to the invention can be provided jointly or independently from one another. Moreover, application variants can provide a use in other contexts in which a, in particular sterile, garment or harness is required, for example a clean room of a laboratory.
[0037] The toga or hood 1 of the present example is suitable to be worn by a surgeon during an intervention in an operating room, over the hard hat 100. The latter, in the present example, is of instrumented type, since it is provided with ventilation means and sensors, as it will be illustrated hereinafter.
[0038] The assembly of helmet 100 and toga 1 can consider substantially symmetric with respect to a sagittal plane of the operator. Figure 2A shows a longitudinal axis L as front trace of such sagittal plane.
[0039] The helmet 1 comprises a main frame, or body, 190 suitable for circumscribing the head of the healthcare worker. The frame 190 is formed by a plurality of uprights which define as a whole a structure of reticular type. The latter is suitable to envelop the subject’s head so as to anchor firmly and stably the helmet 1 , while leaving head areas not covered by the latter.
[0040] In particular, the frame 190 mainly comprises:
[0041] - a sagittal upright 101 , extending at the apical portion of the skull in a postero- anterior direction;
[0042] - a front frame 110, configured to circumscribe the operator’s face and to be connected removably to the transparent lens 20; and
[0043] - a lateral and posterior, or occipital, portion 102, configured to envelop posteriorly and laterally the operator’s head.
[0044] In the present example, the front frame 110 has a substantially quadrilateral shape with rounded angles, since it is defined by an upper segment 111 , a lower segment 112, a first left lateral segment 113 and a second right lateral segment 114.
[0045] As shown in Figure 1 , the frame 110 can further have two lateral appendixes, respectively designated with 115 and 116, which depart, each one, from a respective lateral segment 113, 114. Each appendix 115, 116 is formed by oblique segments integral with one another and with the respective lateral segment 113, 114, so as to define a substantially trapezoid peripheral structure which delimits a central empty space.
[0046] At each lateral segment 113, 114 of the frame 110 mechanical connection elements 250 to the lens 20 are provided, configured to engage with corresponding connection elements 150 of the lens itself. The connection elements 150, 250 can be shape- coupling means, in particular configured to engage by simple pressure of the lens 20 on the frame 110.
[0047] In the present embodiment, such connection elements 150 are of Velcro® type. Preferably, on the frame 110, in substantially centred position on the upper segment 111 , additional connecting means 126 to the lens 20 is provided. In the present embodiment such means can consist of a hook configured to insert in a seat 26, arranged centrally and frontally on a peripheral region 21 of the lens itself.
[0048] When the element 100 and toga 1 are worn, the operator’s head is isolated from the contact with the external environment. Between the transparent lens 20 and the operator’s face remains defined an internal environment 500 which has to be ventilated to guarantee the comfort conditions.
[0049] The helmet 100 then comprises ventilation means 120, or means of air forced circulation, of the environment 500. Such ventilation means 120 comprises an air suction device 121 and a suction duct 122 in fluid communication with the device 121. Such components are arranged at the sagittal upright 101 of the frame 190. In particular, the suction duct 122 can be implemented as part of the upright itself. Device 121 and duct
[0050] 122 are configured to evacuate the exhaust air present in said environment 500, by generating a flow F of air rising from the environment 500 itself and inside the suction duct 122. The sucked air can be evacuated towards outside by means of an outlet duct
[0051] 123 arranged posteriorly the device 121 , preferably implemented as well as part of the sagittal upright 101.
[0052] In the present embodiment the suction device 121 is completely onboard and self- contained, not requiring air or power supply connections from an external environment. In particular, the device 121 can include a valve, a related motor and a related portable power supply.
[0053] The ventilation means of the helmet 100 can also provide an additional device 130 for the air forced circulation in the environment 500, which works by introducing external, in case filtered / decontaminated, air. Advantageously, such additional device 130 is configured to introduce air from below, by assisting the flow generated by the suction device 121. The device 130 can be positioned at a lower portion of the helmet 100. By way of example, in Figure 1 the device 130 is shown as associated to an occipital portion of the helmet 100.
[0054] Preferably, the air intake device 130 is implemented by means of the ventilation means distinct from those of the suction device 121 and then it can include its own valve, motor and portable power supply.
[0055] Based upon an embodiment example, the helmet 100 comprises a control unit 600, designated by way of example in Figure 1 , for example in data communication with sensor or transducer means 601 , designated by way of example too in Figure 1. The sensors or transducers 601 can detect or estimate one or more entities selected in a group comprising: percentage of CO2 in the environment 500; temperature in the environment 500; movement of the healthcare worker’s head.
[0056] The control unit 600 can control the flow rate and / or speed of air sucked in and / or introduced by the ventilation devices 121 , 130 depending upon the data provided by the sensors or transducers 601.
[0057] The control unit 600 can even control the activation or deactivation of the ventilation means 121 , 130 and / or the switching on and switching of a light for illuminating of the operating environment arranged on the helmet itself.
[0058] Preferably, the hood or toga 1 is suitable to be sterilized and provided folded in a package sterile too.
[0059] In the present embodiment, the hood 1 is of disposable type.
[0060] Analogously to the known systems, on the hood 1 an internal face, or versant, 15 and an external face, or versant, 16, can be identified, so defined since the first one, after wearing, is in direct contact with the subject’s body whereas the second one is indeed directed towards the external environment.
[0061] The hood 1 is configured to cover completely the head, the neck and an upper portion of the chest of the operator who wears it and this by means of its own enveloping main body 10. The latter is made of a flexible material and preferably it is made of fabric.
[0062] The main body 10 is fixed, at its own front opening 18, on the above-mentioned peripheral region 21 of the front vision lens 20, outside it. Such peripheral region 21 constitutes the peripheral portion of the lens 20, which then defines the overall profile thereof.
[0063] The lens 20, in use, positions in front of the frame 110 of the helmet 100 and then at the operator’s face, advantageously extending on a wide face portion so as to guarantee an adequate and comfortable visual field during the surgical operation and an inspection of the operating site.
[0064] The lens 20 has the above mentioned two lateral elements 150 for the removable mechanical connection to the front frame 110 of the helmet 100. Each connection element 150 is positioned at an intermediate lateral portion of the lens 20 spaced apart from the rear portion of the peripheral region 21. In other words, the lens 20 shields on anteriorly, that is frontally, completely the frame 110 and the subject’s face and extends beyond such frame 110 on both sides of the head, substantially as far as the operator’s ears.
[0065] Therefore, with respect to the known lenses, the front lens 20 has two additional lateral portions 23 and 24 for widening the visual field, which extend posteriorly with respect to the connection elements 150 and to the front frame 110 in a latero-lateral, that is antero- posterior direction.
[0066] Each portion for widening the visual field 23, 24 has a tapered, preferably rounded, shape, with width decreasing in an antero-posterior direction, that is a substantially rounded arrowhead shape. For a suitable widening of the visual field, each portion 23, 24 is defined by a perimetral profile continuous with that of the frontal and antero-lateral region of the lens 20, without steps or discontinuities.
[0067] Advantageously, each one of the additional portions 23, 24 allows a widening of the visual field, with respect to the surface of the lens 20 without them, at least of approximately 10-15%.
[0068] The main body 10 of the toga or hood 1 is advantageously implemented in one single piece. A front portion 11 and a rear portion 12 can be identified thereon, connected and made integral by means of two opposite side portions 13 and 14.
[0069] The front portion 11 can have a lower appendix 111 shaped like a bib, which extends, in use, on the operator’s chest. The bib-shaped appendix 170 determines a greater longitudinal extension for the front portion 11 with respect to the posterior one 12.
[0070] On the posterior portion 12 of the main body 10 respective first longitudinal ends of a first and a second lateral tie-rod, respectively 31 and 32, are fixed, arranged on opposite sides with respect to the longitudinal axis L, that is the operator’s sagittal plane.
[0071] Advantageously, the tie-rods 31 and 32 are fixed to the main body 10 at a lower periphery of the posterior portion 12.
[0072] The lateral tie-rods 31 and 32, in use, extend laterally outside the posterior portion 12 and are configured to be grasped by the operator upon wearing the hood 1 with the purpose of unwinding said posterior portion 12 and making it to cover the posterior portion of the head, neck and chest. The tie-rods 31 and 32 can be configured so as to allow to keep a distance between the subject’s arms and the main body of the hood upon wearing in a sufficient way to avoid contacts between the outside of the main body of the hood 1 and the arms of the operator who performs autonomously the wearing procedure.
[0073] Advantageously, the tie-rods 31 and 32 also have a length so as to be able to be enveloped, at the end of wearing the hood 1 , around the chest in order to be knotted to one another on the front portion 11 of the main body 10, for example on the bib-shaped portion 170 thereof.
[0074] In a preferred embodiment variant, the tie-rods have, each one, a length comprised within a range of approximately 20-150 cm.
[0075] The tie-rods 31 and 32 can be made of the same material of the main body 11 , in particular in fabric, or even in different material, for example with elastic properties.
[0076] The helmet 100 and / or the hood or toga 1 can provide one or more elements filtering viruses and / or bacteria. The hood of the invention can also be provided in assembly, or kit, with a surgical hard hat like the one mentioned above and / or with a gown, the latter wearable above a lower portion of the main body of the hood itself. The present invention has been so far described with reference to preferred embodiments thereof. It is to be meant that other embodiments belonging to the same inventive core may exist, as defined by the protective scope of the here below reported claims.
[0077] Exemplifying numbering of the components in Figures
[0078] 1 - hood or toga
[0079] 100 - hard hat or helmet
[0080] 1000 - protection assembly
[0081] 500 - environment housing the surgeon’s head defined by the toga or hood
[0082] 600 - control unit of the hard hat
[0083] 601 - sensors
[0084] L - Longitudinal axis of the assembly I trace of the sagittal plane
[0085] F - exemplification of the suction air flow
[0086] 190 - body or main frame of the hard hat
[0087] 101 - sagittal upright of the hard hat
[0088] 102 - lateral and occipital portion of the hard hat
[0089] 110 - front frame of the hard hat
[0090] 111-114 - upper, lower, left lateral, right lateral segments of the frame
[0091] 115, 116 - additional lateral portions of the frame
[0092] 150 - means for connecting the frame to the vision lens of the hood
[0093] 120 - ventilation means
[0094] 121 - actuation system of the suction means
[0095] 122 - suction anterior duct
[0096] 123 - discharge posterior duct
[0097] 126 - hook for vision lens
[0098] 130 -air introduction means
[0099] 15 - internal face of the hood
[0100] 16 - external face of the hood
[0101] 20 - vision lens of the hood
[0102] 21 - peripheral region of the vision lens
[0103] 22 - central I front region
[0104] 23, 24 - latero-lateral regions of the vision lens
[0105] 26 - hooking means of the vision lens
[0106] 250 - means for connecting removably the lens to the frame of the hard hat 10 - enveloping main body of the hood
[0107] 11 - front portion of the enveloping main body
[0108] 170 - Bib-shaped appendix of the front portion
[0109] 12 - posterior portion of the enveloping main body 13, 14 - opposite lateral portions of the enveloping main body
[0110] 18 - front opening of the enveloping main body
[0111] 31 , 32 - lateral tie-rods of the hood
Claims
CLAIMS1. A protective hood or toga (1) for medical use, especially in surgery, which hood or toga is configured to be worn over an instrumented medical helmet (100), which hood or toga (1) includes:■ a transparent front lens (20), able to position, in use, at the operator's face to allow a visual control of the operating environment;■ an enveloping main body (10), fixed to said lens (20) at a peripheral region (21) of the lens and configured to completely cover the operator's head and neck;■ two connection elements (150) configured for the removable mechanical connection of said lens (20) to a front frame (110) of the helmet (100), said connection elements arranged bilaterally each at an intermediate portion of said lens (20) spaced apart from said peripheral region (21), said lens (20) having two lateral portions for widening the visual field (23, 24) which extend posteriorly with respect to said connection elements (150) in a latero-lateral direction.
2. The hood or toga (1) according to claim 1 , wherein said connection elements (150) are shape-coupling means, in particular configured to engage with the frame (110) of the helmet (100) by pressure.
3. The hood or toga (1) according to the preceding claim, wherein said connection elements (150) are of the Velcro® type.
4. The hood or toga (1) according to any one of the preceding claims, wherein each of said visual field widening portions (23, 24) has a tapered shape, preferably rounded, with width decreasing in an antero-posterior direction.
5. The hood or toga (1) according to any one of the preceding claims, wherein each of said visual field widening portions (23, 24) has a substantially rounded arrowhead shape.
6. The hood or toga (1) according to any one of the preceding claims, wherein said enveloping main body (10) is made of fabric.
7. The hood or toga (1) according to any one of the preceding claims, wherein said enveloping main body (10) comprises a front portion (11) and a rear portion (12) connected and made integral by two opposite side portions (13, 14).
8. The hood or toga (1) according to any one of the preceding claims, which is sterilizable or supplied sterile in a package.
9. The hood or toga (1) according to any one of the preceding claims, which is of the disposable type.
10. The hood or toga (1) according to any one of the preceding claims, wherein saidlens (20) also has one or more further connection elements to the frame (110) of the helmet (100), in particular hooking means (26), arranged in a central and frontal position.
11. The hood or toga (1) according to any one of the preceding claims, wherein each additional widening portion (23, 24) has a perimetral profile continuous with that of the remaining frontal and lateral part of the lens (20), without steps or discontinuities.
12. The hood or toga (1) according to any one of the preceding claims, wherein each additional widening portion (23, 24) allows a widening of the visual field, with respect to the remaining frontal and lateral surface of the lens (20), of at least 10-15%.
13. A protective helmet (100) adapted to be worn by a healthcare worker, in particular in a surgical intervention, which helmet (1) comprises: a main frame (190) suitable for circumscribing the head of the healthcare operator and having:- a sagittal upright (101), extending at the apical part of the skull in a postero-anterior direction;- a front frame (110), configured to circumscribe the operator's face and to be removably connected to a transparent lens (20) supplied in association with a toga or hood (1); and- a lateral and rear portion (102), configured to wrap the operator's head laterally and posteriorly; ventilation means (120) of an environment (500) housing the operator's head and defined by said main frame (190) and by the transparent lens (20), which ventilation means (120) comprise an air intake (121) and an intake duct (122) arranged at said sagittal upright (101) of said main frame (190) and configured to evacuate the exhaust air from said environment (500) generating a flow of air rising from said environment (500) and into said suction duct (122).
14. The helmet (1) according to the preceding claim, wherein said suction device (121) comprises an air evacuation duct (123) positioned at a rear portion of said sagittal post (101).
15. The helmet (1) according to claim 11 or 12, wherein said suction device (121) is completely onboard and self-contained, not requiring air or power supply connections from an external environment.
16. The helmet (1) according to any one of claims 11 to 13, comprising an air intake device (130), configured for an intake of air from below into said environment (500).
17. The helmet (1) according to the preceding claim, wherein said air inlet device(130) is made by means of ventilation components distinct from said suction device (121).
18. The helmet (1 ) according to any one of claims from 11 to 15, comprising a control unit (600) of the flow rate and / or speed of the air sucked in and / or introduced by said ventilation means (121 , 130).
19. The helmet (1) according to any one of claims 11 to 16, comprising sensors or transducers (601) of one or more entities selected in a group comprising: percentage of CO2 in said environment (500); temperature in said environment (500); movement of the health worker's head.
20. The helmet (1) according to the preceding claim, wherein said sensors or transducers (601) are associated with a control unit (600) of the flow rate and / or speed of the air sucked in and / or introduced by said ventilation means (121 , 130).
21. The helmet (1) according to claim 17 or 18, wherein said sensors or transducers (601) are associated with a control unit (600) of the activation or deactivation of said ventilation means (121 , 130) and / or of the switching on and off of a light for illuminating the operating environment arranged on the helmet itself.
22. The helmet (1) according to any one of claims from 11 to 19, comprising removable connection means (250) of said front frame (110) to the transparent lens (20), arranged at lateral segments (113, 114) of said front frame (110).
23. An assembly (1000) comprising a hood or toga (1) according to any one of claims 1 to 10 and a helmet (100) connectable to said lens (20) by respective helmet connection elements (250) configured to engage said connection elements (150) of the lens (20).
24. The assembly according to the preceding claim, wherein said helmet (100) is made according to any one of claims 11 to 20.
25. The assembly according to claim 21 or 22, which is configured as a kit.