TECHNICAL FIELD

The present invention generally relates to a device for fixing intracorporeal access devices to the body of a patient - in particular airway management devices, such as endotracheal tubes, nasotracheal tubes and laryngeal masks, devices for access to blood vessels, tubes, catheters and drainage tubes - that is useful and practical in the medical field and in particular in anaesthesia and resuscitation, in intensive care, in medical transports and in emergency medicine both inside and outside the hospital.

BACKGROUND

In the medical- surgical field, it is common practice to insert in a patient an intracorporeal access device of a different nature depending on the specific medical need that the device must fulfil. For example, it is known to insert devices for access to blood vessels for the administration of drugs and/or liquids, nasogastric tubes for feeding the patient, catheters or drainage tubes for evacuating liquids in bedridden patients, airway management devices, such as endotracheal tubes, to allow for assisted breathing and so on.

By way of non-limiting example, specific reference will be made below to the intracorporeal access devices for the management of the airways. In this regard, the endotracheal intubation technique is known and commonly used in the medical field, with which a pipe-shaped tube, called endotracheal tube, is inserted into the trachea to an unconscious patient or to be subjected to narcosis in order to allow assisted breathing and to protect the airways.

The endotracheal tube is positioned by a doctor (or possibly, where permitted by law, by other trained healthcare personnel) who identifies the correct position (which from here on, in this description and in the attached claims, will be indicated as "determined anatomical position of use").Normally, in this determined anatomical position of use, the endotracheal tube engages the patient's trachea and emerges for a stretch from the patient's mouth, so as to have an accessible distal end to which assisted ventilation devices are generally connected. Once the endotracheal tube has been positioned in the determined anatomical position of use, it must be properly fixed to prevent it from moving from that position. In fact, excessive movements of the endotracheal tube can cause dislocation thereof and the tube to come off the trachea. This occurrence, known as "accidental extubation", is very dangerous for the patient and must therefore be carefully avoided. Furthermore, the displacement of the endotracheal tube along its longitudinal axis can cause injuries to the patient, such as tracheal, laryngeal and buccal lacerations.

This practice can be generalized to any intracorporeal access device, for which it is known to previously identify a determined anatomical position of use in which the device is able to perform its function and then execute the positioning of the device in said position. Correspondingly, it is necessary to prevent displacements of the device, once positioned in the determined anatomical position of use, in order to prevent injuries to the patient's access routes. Nowadays, non-specific patches, of the type generally used also for dressings, are normally used to fix the intracorporeal access devices in the determined anatomical position of use. This solution, albeit very cheap and simple, does not adequately guarantee the prevention of accidental dislocation and leaves excessive mobility to the intracorporeal access device along the longitudinal axis. Furthermore, these non-specific patches do not have sufficient adhesiveness and are often ineffective in avoiding the accidental removal in the event of an involuntary sudden traction on the device. Another drawback of these known types of patches used for fixing intracorporeal access devices lies in the fact that, being non-specific and non-sterile devices, they favour the development of infections, in particular in paediatric and post-operative patients.

From document WO 95/18645A1 fixing devices for endotracheal tubes made in the form of a patch comprising portions intended to adhere to the patient's face and portions specifically intended to adhere to the tube are also known. These devices, while offering greater stability of the endotracheal tube, are not yet suitable for reliably preventing extubation or dislocation of the tube that could cause injuries to the patient.

The same problems are encountered in fixing other similar intracorporeal access devices such as blood vessel access devices, catheters and/or drainage tubes.

A device for blocking a catheter once it has been positioned in place is also known from US 2017/326338Al.The device comprises a base patch to which a braided sock, in which the catheter is retained, is attached. In fact, the sock has the peculiarity of reducing its internal diameter according to its own length. In this way, once installed with a diameter such as to exert a radial retaining force against the catheter, it is able to counteract a significant displacement thereof. A small displacement of the catheter is in fact sufficient to cause a further elongation of the sock, thus increasing the radial retaining force exerted on the catheter and therefore preventing further displacements. US 2017/326338A1 further discloses the use of a sensor to monitor one or more parameters of the line, including a voltage exerted on the braided sock. However, this device is scarcely suitable for the effective blocking of intracorporeal access devices since the blocking action exerted by the sock is activated by the elongation thereof and therefore only downstream of an axial movement by the device which, moreover, could cause injuries to the patient. Furthermore, the elasticity of the braided sock can be subject to yielding, reducing with use the retaining force exerted on the catheter and therefore increasing the displacement necessary for the effective activation of the blocking.

OBJECTS AND SUMMARY OF THE INVENTION

In light of the above, the problem underlying the present invention is that of devising a fixing device for intracorporeal access devices that solves the technical problem described above, obviates the drawbacks and overcomes the limits of the prior art, allowing to effectively avoid or prevent the accidental displacement of the intracorporeal access devices and/or injuries to the patient's access routes.

Within this problem, an object of the present invention is to realise a fixing device for intracorporeal access devices that is able to prevent any longitudinal and/or torsional movement of the intracorporeal access device, warning healthcare workers with visual and/or acoustic signals.

Another object of the present invention is to realise a fixing device for intracorporeal access devices which is at the same time more practical and easier to apply than the prior art.

A further object of the invention is to realise a fixing device for intracorporeal access devices which, if used for the management of airways, allows the access to the oral cavity of the intubated patient.

Another object of the invention is to realise a fixing device for intracorporeal access devices which is easy to manufacture and economically competitive.

Not least object of the invention is to realise an alternative to the prior art.

In accordance with one of the first aspects thereof, the invention therefore relates to a device for fixing intracorporeal access devices to a patient in a determined anatomical position of use, comprising a fixing base adapted to be fixed to the patient's body and to the intracorporeal access device so as to retain the intracorporeal access device in said determined anatomical position of use.

According to the present invention, the fixing device for intracorporeal access devices comprises a fixing base configured to be fixed to the patient's body and an adhesive fixing flap having longitudinal extension along a development axis. The adhesive fixing flap is bound to the fixing base and is configured to be fixed to the intracorporeal access device in order to retain the intracorporeal access device in the determined anatomical position of use.

According to the present invention, a strain gauge is also provided which is functionally connected to the adhesive fixing flap and is configured to detect a traction applied to the adhesive fixing flap.

The Applicant has identified that thanks to the use of a strain gauge functionally connected to the adhesive fixing flap and configured to detect a traction and/or a torsion applied to the adhesive fixing flap it is possible to detect a traction and/or torsion force applied to the adhesive fixing flap even before the device is subject to displacements. In this way, it is possible to intervene even before an even minimal dislocation of the device takes place and thus preventing injuries to the patient.

The fixing device for intracorporeal access devices according to the present invention is also simple to manufacture, with reduced production costs.

The present invention may have at least one of the following preferred features; the latter may in particular be combined with one another as desired in order to meet specific application needs.

In a variant of the invention, the strain gauge is chosen in such a way as to have a gauge factor equal to at least 1.8, preferably equal to at least 2.

Alternatively, or in addition, the strain gauge is chosen in such a way as to be configured to detect a deformation of the order of 10 pm, preferably of the order of 5 pm and more preferably of the order of 1 pm for each 1 mm of size of the strain gauge, measured along the deformation direction.

The Applicant has identified that these characteristics of the strain gauge advantageously ensure to prevent any perceptible displacement of the fixed intracorporeal access device by the fixing device according to the invention, thus ensuring a substantial absence of injuries to the patient caused by the device.

In a variant of the invention, the strain gauge is of the electrical resistance or semiconductor type, preferably of the full bridge type.

The specific type of strain gauges identified by the Applicant is particularly suitable for use in the fixing device according to the invention, since it allows to detect displacements along any direction in the space.

In a variant of the invention, the fixing adhesive flap is connected to the fixing base by means of a prolongation configured to allow an axial rotation movement of the fixing adhesive flap about an axis parallel to the development axis.

Preferably, the prolongation has an axial development along an axis parallel or coincident with the development axis and has a width, measured in the direction transverse to the development axis, lower than the width of the adhesive fixing flap, but preferably not lower than half of said width of the adhesive fixing flap, measured in the direction transverse to the axis.

Preferably, the prolongation is made as an axial continuation of a short side of the adhesive fixing flap or as a lateral extension of a portion of a long side of the adhesive fixing flap.

In a variant of the invention, the strain gauge is bound to or integrated into the adhesive fixing flap.

In this way, the sensitivity of the strain gauge in detecting traction and/or torsion forces which generate still imperceptible displacements of the intracorporeal access device is advantageously further increased.

In a variant of the invention, the fixing base and/or the adhesive fixing flap are made as a multilayer element, comprising at least one upper filtering layer and an at least partially adhesive lower layer.

Preferably, the lower layer of the fixing base is of the multicompartmental type, being provided with at least one central adsorbent compartment and with an adhesive peripheral compartment. More preferably, the at least one central adsorbent compartment is configured to adsorb liquids. For example, the at least one central adsorbent compartment comprises a hypertonic gel or hydrocolloid substance, such as an absorbent open cell polyurethane foam.

In this way, conveniently, the fixing device is capable of adsorbing any liquids produced by the patient while he is wearing the fixing device, for example by perspiration, preventing them from affecting the adhesion of the fixing device to the patient.

Preferably, the adhesive peripheral compartment is made of a material that can be validated with respect to the ISO 10993 standard and preferably similar to one or more of the following known adhesive materials:3M-MED 1522, 3M 9425HT, 3M 9629PC, 3M 9415PC and 3M 9415PC. Advantageously, this type of adhesive has the advantage of being usable in the clinical and medical field, while ensuring excellent adhesion to the patient's skin.

In a variant of the invention, the strain gauge is electrically connected to at least one connector configured to provide a connection interface to a remote electronic interface device or to an on board electronic board that can be mechanically bound to the fixing base.

This embodiment conveniently allows to electrically connect, in a removable way, the electronic processing devices to the fixing device, drastically reducing the production costs of a fixing device.

Preferably, the fixing base and/or the adhesive fixing flap additionally comprise an intermediate layer configured to house in its inside the strain gauge, and possibly the connector for connecting to the on-board electronic board.

Preferably, the upper layer covers the strain gauge and integrates into its thickness the connector for connecting to the on-board electronic board.

Preferably, the upper layer is made of a filtering fabric suitable for retaining the passage of microorganisms such as bacteria and viruses, preferably in at least one among non-woven polypropylene (PP) fabric of the type Spunbond - Meltblown - Spunbond Nonwoven, non-woven polyester (PE) fabric or silver-filled non-woven fabric, possibly covered with a polyurethane layer.

Advantageously, the realisation of the upper layer in filtering fabric suitable for retaining the passage of microorganisms offers greater protection to healthcare workers with respect to bacteria and/or viruses carried by the patient.

In a variant of the invention, the fixing base comprises a plurality of suture holes configured to allow the fixing to the patient's skin by means of a suture.

In a variant of the invention, the fixing device additionally comprises a cover element configured to be positioned at an area for intracorporeal access to the patient in which to insert the device and to cover an area in which the adhesive fixing flap adheres to the device.

Preferably, the cover element is made of a filtering fabric suitable for retaining the passage of microorganisms such as bacteria and viruses, preferably in at least one among the non-woven polypropylene (PP) fabric of the type Spunbond - Meltblown - Spunbond Nonwoven, non-woven polyester (PE) fabric or silver-filled non-woven fabric, possibly covered with a polyurethane layer.

Similarly, to the above, the cover element made of filtering fabric suitable for retaining the passage of microorganisms entering the patient’s access area offers greater protection to the patient with respect to bacteria and/or viruses.

In a variant of the invention, the fixing device additionally comprises an on-board electronic board which can be bound integrally to the fixing base by coupling to the connector.

Preferably, the on-board electronic board comprises at least a radio module and/or a wired connection plug for the connection to a remote electronic device and/or an acoustic signal source and/or a light signal source.

In this way it is conveniently possible to connect the electronic board wirelessly and/or wired to alarm signalling devices, such as acoustic and/or visual signal generators or a smartphone.

In a variant of the invention, the fixing base comprises a lateral portion configured to be fixed laterally to an area for intracorporeal access to the patient in which to insert the device, a first continuation flap and a second continuation flap protruding longitudinally from the lateral portion, parallel to each other, the adhesive fixing flap being connected to the lateral portion at a position between the first continuation flap and the second continuation flap and developing parallel to the first and to the second continuation flap.

Alternatively, the fixing base comprises a lateral portion configured to be fixed laterally to an area for intracorporeal access to the patient in which to insert the device and a first continuation flap protruding longitudinally from the lateral portion, the adhesive fixing flap being connected to the lateral portion at the first continuation flap and developing parallel thereto.

BRIEF DESCRIPTION OF THE DRAWINGS

Further characteristics and advantages of the present invention will be more evident from the following description of some preferred embodiments thereof made with reference to the appended drawings.

The different features in the individual configurations can be combined with each other as preferred according to the previous description, should it be necessary to avail of the advantages resulting specifically from a particular combination.

In such drawings,

- Figure 1 is a perspective view of a first embodiment of a fixing device for intracorporeal access devices according to the present invention;

- Figure 2 is a top plan view of the fixing device for intracorporeal access devices of Figure 1;

- Figure 3 illustrates the fixing device for intracorporeal access devices of Figure 1 together with the face of a patient and an intracorporeal access device, in particular an airway management device, in a step prior to use;

- Figure 4 illustrates the fixing of an intracorporeal access device for the access to the airways of a patient by means of the fixing device for intracorporeal access devices of Figure 1;

- Figure 5 illustrates a functionality of the fixing device for intracorporeal access devices of Figure 1 during use;

- Figure 6 is a top plan view of a fixing device for intracorporeal access devices in accordance with a second embodiment of the present invention;

- Figure 7 is a section view along line I-I of the fixing device for intracorporeal access devices of Figure 6;

- Figures 8-10 are each a top plan view of a fixing device for intracorporeal access devices according to a third, fourth and fifth embodiment of the present invention, respectively;

- Figure 11 is a top plan view of a fixing device for intracorporeal access devices according to a sixth embodiment of the present invention; and

- Figure 12 illustrates the fixing of an intracorporeal access device for nasotracheal access of a patient by means of the fixing device for intracorporeal access devices of figure 11;

- Figure 13 is a top plan view of a fixing device for intracorporeal access devices according to a seventh embodiment of the present invention;

- Figure 14 illustrates the fixing of an intracorporeal access device for the multiple, nasotracheal and nasogastric access of a patient by means of the fixing device for intracorporeal access devices of Figure 13; and

- Figures 15 and 16 schematically illustrate the fixing of an intracorporeal access device for intrathoracic access of a patient by means of the fixing device for intracorporeal access devices of figure 6.

DETAILED DESCRIPTION OF THE INVENTION

In the following description, for the illustration of the figures, identical numbers or reference symbols are used to indicate construction elements with the same function. Further, for illustration clarity, some references may not be repeated in all the figures.

While the invention is susceptible to various modifications and alternative constructions, certain preferred embodiments are shown in the drawings and are described hereinbelow in detail. However, it is to be understood that there is no intention to limit the invention to the specific embodiment illustrated but, on the contrary, the invention intends to cover all the modifications, alternative and equivalent constructions that fall within the context of the invention as defined in the claims.

The use of “for example”, “etc.”, “or” indicates non-exclusive alternatives without limitation, unless otherwise indicated. The use of “comprises” and “includes” means “comprises or includes, but not limited to”, unless otherwise indicated.

With reference to Figures 1-5, a first preferred embodiment of a fixing device for intracorporeal access devices is illustrated, globally indicated with the reference number 1.

The fixing device for intracorporeal access devices 1 according to the present invention has the function of fixing an intracorporeal access device in a determined anatomical position of use in which it has been positioned by a healthcare worker.

In the present description and in the attached claims, the term "intracorporeal access device" means, in a very general way, any of the known devices that are normally inserted into a patient's body to have access to the specific anatomical parts of the same patient, including the airways, the gastric tract, the blood vessels, the urinary tract, and so on.

In the present description and in the attached claims, "determined anatomical position of use" means, in a very general way, any position of use in which a healthcare worker decides that the intracorporeal access device must be fixed by means of the fixing device 1.

Purely by way of non-limiting example, the fixing device described below makes particular reference to a device for fixing an airway management device T to a patient P, positioned in a determined anatomical position of use following an intubation manoeuvre performed in order to protect the same airways and allow assisted breathing. Airway management devices are in particular endotracheal tubes, nasotracheal tubes and laryngeal masks. In the non-limiting example illustrated, the airway management device consists of an endotracheal tube T.

The fixing device 1 comprises a fixing base 10 adapted to be fixed to the patient's body P - with specific reference to the illustrated example, in particular to the patient's face P - and to the airway management device T so as to retain the latter in the correct anatomical position of use.

In preferred embodiments, the fixing base 10 is made of a flexible, preferably breathable, biocompatible and hypoallergenic plastic material. For example, in some embodiments the fixing base 10 is of a rubbery material, while in other embodiments it can be made of or comprise (possibly in addition to the breathable plastic material) gauze and/or fabric and/or patch.

Conveniently, the fixing base 10 is provided with an adhesive layer 17 configured to adhere to the epidermis of the patient P, like a patch.

According to the present invention, the fixing of the fixing base 10 to the airway management device T is carried out by means of an adhesive fixing flap 20 which can be moulded and which will be better described hereinafter.

In preferred embodiments, including the one shown in Figures 1-5, the fixing base 10 comprises a lateral portion 11 adapted to be fixed laterally to the patient's mouth P, on the cheek of the latter.

This lateral portion 11, which is preferably rectangular, has a sufficient extension to ensure proper adhesion to the face of the patient P. In these embodiments, the fixing base 10 preferably also comprises a first 12 and a second 13 lengthening flap protruding longitudinally from the lateral portion 11, parallel to each other. In the illustrated example, these first 12 and second 13 flaps are also elongated rectangular portions which develop longitudinally and which, in other words, form two fins substantially parallel and spaced apart by a distance that is sufficient to contain the access area in which to insert the device T.

The first 12 and the second 13 lengthening flap are preferably fixed one between the mouth and the nose of the patient P and the other one on the chin of the patient P below the mouth, as illustrated in figure 4. Note that in this way the patient’s access area - in this case the mouth of the patient P - is completely free and accessible.

Obviously, the lateral portion 11 of the fixing base 10 can be fixed indifferently to the right or to the left of the mouth of the patient P, according to needs.

In the embodiment of figures 1-5, the adhesive fixing flap 20 is connected to the lateral portion 11 in a position interposed between the first flap 12 and the second flap 13, forming a continuation of the lateral portion 11 and has an elongated conformation which develops along a development axis A.

As will be seen below with reference to other embodiments, the adhesive fixing flap 20 generally originates at the position from which the first 12 and/or the second 13 flap originates, being able to be indifferently connected to the lateral portion 11 and/or to one between the first 12 and the second 13 flap.

Referring now in greater detail to the adhesive fixing flap 20, this preferably consists of a tab or an adhesive strip having, for example, a longitudinally elongated rectangular shape.

In preferred embodiments, the fixing adhesive flap 20 is made of a very flexible material, such as for example rubber or adhesive cloth.

The adhesive fixing flap 20 can optionally be made of the same material as the one of which the fixing base 10 is made or other mouldable plastic material, and optionally, in some particular embodiments, it comprises threads or strips of a material with a low elastic coefficient, such as metal. In any case, the adhesive fixing flap 20 is provided with an adhesive surface adapted to adhere to the external surface of an intracorporeal access device T, for example to the external surface of an endotracheal tube as in the illustrated example.

The adhesive fixing flap 20 is therefore configured to be fixed to the intracorporeal access device T and preferably to be wound around the intracorporeal access device T itself (preferably rolled up into a spiral), with the adhesive surface thereof in contact therewith, in this way an effective fixing of the intracorporeal access device T, as illustrated in figure 4, being achieved.

According to the present invention, the fixing device 1 further comprises a detection device 50 configured to measure a traction applied to the adhesive fixing flap 20 in the absence of movement by the fixing device 1. In this way it is possible to detect any traction applied to the airway management device T when this is fixed to the fixing flap 20 and is still in the determined anatomical position of use. In particular, the detection device 50 comprises a strain gauge, such as for example a resistance electrical strain gauge (or a device known as “strain gage”), an electrical semiconductor strain gauge, an electrical capacitive strain gauge, an electrical inductive strain gauge, an optical strain gauge, an acoustic strain gauge or other strain gauge of known type.

In a preferred embodiment, the strain gauge 50 is of the resistance electrical type, for example consisting of a grid of very thin metal wire rigidly applied to a support substrate, or of the semiconductor electrical type.

Specifically, the use of an electrical resistance or semiconductor strain gauge of the "full bridge" type is particularly advantageous. This specific type of strain gauge comprises four independent sensitive grids, oriented according to the diagonals of a square. This allows detecting dimensional variations of the grids in the different spatial directions and therefore the corresponding possible surface deformations of the device T to which the adhesive fixing flap 20 - which carries the strain gauge 50 - is bound.

In particular, the strain gauge 50 is chosen in such a way as to have a transduction factor, also "gauge factor" equal to at least 1.8, preferably equal to at least 2.

Still, the strain gauge 50 is chosen in such a way as to be configured to detect a deformation of the order of 10 pm, preferably of the order of 5 pm and more preferably of the order of 1 pm for each 1 mm of size of the same strain gauge, measured along the deformation direction.

The strain gauge 50 is mechanically connected to the fixing flap 20 so as to be able to measure any force applied to the fixing flap 20 in a direction moving away from or approaching the fixing base 10. In particular, the strain gauge 50 is bound to, for example by gluing, or integrated into the fixing flap 20.

Specifically of the embodiment illustrated in Figures 1-5, the detection device 50 is positioned at the base of the fixing flap 20, interposed between the fixing base 10 and the fixing flap 20, and acts as a connection of the fixing flap 20 to the fixing base 10.

In some embodiments, the detection device 50 is limited to converting the detected traction and/or torsion force into a signal (or an electrical quantity, such as for example voltage or current) which is transmitted to an electronic interface device 90 (such as a computer or a monitor or any device provided with a control logic) which interprets this signal (or electrical quantity) so as to determine a measure of the traction force detected and, as a function of this, provides messages or visual and/or acoustic signals (such as for example the numerical value of the traction force on a screen and/or alarm signals when the traction force exceeds a predetermined threshold value).

Advantageously, in order to transfer the signals and/or measurements produced by the detection device 50 to the electronic interface device 90 as a function of the traction force applied to the airway management device T, the fixing device 1 comprises a data and/or signal transmission system operatively connected to the detection device 50 and connected or connectable to the aforementioned electronic interface device 90.

The data and/or signal transmission system preferably comprises a connection cable 40 operatively connected to the detection device 50 (for example suitably electrically connected thereto) and configured to be connected to the electronic interface device 90, for example by means of a connector 49 positioned at the end of the connection cable 40 itself. In the embodiments in which the data and/or signal transmission system comprises a connection cable 40, this is preferably housed within the thickness of the fixing base 10, or fixed above or below it. In a preferred embodiment, the connection cable 40 is a flat coaxial or bipolar cable.

The electronic interface device 90 is preferably a multifunction monitor or a computer or any electronic device of known type capable of receiving and interpreting analogue or digital signals and providing visual and/or acoustic messages as a function of the data or signals relating to the detections and/or measurements made by the detection device 50.

More in detail, the electronic interface device 90 is preferably configured to emit an alarm signal when the traction detected by the detection device 50 exceeds a predetermined threshold value, as schematically represented in Figure 5.

Even more preferably, the electronic interface device 90 is configured to emit a first signal (alert signal) when the traction force detected by the detection device 50 exceeds a first predetermined threshold value and a second signal (alarm signal) when the traction force detected by the detection device 50 exceeds a second predetermined threshold value higher than the first threshold value. These threshold values can be determined in accordance with the scientific literature on the subject which indicates the traction values to be considered as potentially dangerous or critical. This way prevents accidental displacement or extraction.

For example, in a particular embodiment, the first threshold value is 10N and the second threshold value is 15N, so that when the fixed airway management device T is subjected to a traction force between 10N and 15N the electronic interface device 90 emits an alert signal and when the fixed airway management device T is subjected to a traction force greater than 15N, the electronic interface device 90 emits an alarm signal (different and recognizable with respect to the alert signal).

With reference to Figures 6 and 7, a second embodiment of the fixing device 1 according to the present invention is illustrated and is also used in this case to fix an endotracheal tube in the determined anatomical position of use.

The fixing device 1 of Figures 6 and 7 comprises an adhesive fixing flap 20 bound to the fixing base 10 in such a way as to allow a rotation of the flap 20 about an axis parallel to the development axis A thereof.

To this end, in the embodiment of figures 6 and 7, the adhesive fixing flap 20 is connected to the lateral portion 11 of the fixing base 10 at its short side, by means of a prolongation 11a which develops parallel to the axis A.

In particular, the prolongation 11a has a width smaller than the width of the adhesive fixing flap 20, but preferably not lower than half of this width of the adhesive fixing flap 20. Specifically, in Figure 6, the prolongation 1 la is made as a continuation of a long side of the adhesive fixing flap 20. Thanks to the connection by means of the prolongation 11a, the adhesive fixing flap 20 can rotate about an axis parallel to its development axis A, in particular an axis passing through the prolongation 11a.

The detection device 50 of the embodiment of figure 6 is fixed on the adhesive fixing flap 20 in an intermediate position thereof and is electrically connected to an integrated clamp 55 in the lateral portion 11 of the fixing base 10. The clamp 55 is configured to accommodate an on-board electronic board 60 designed to process the signal received from the detection device 50 and translate it into a measurement of the value of the traction force.

The on-board electronic board 60 also preferably comprises a radio module 61 for wireless data transfer, for example a Bluetooth module, a Wi-Fi module and so on, through which it communicates with one or more remote devices, such as for example the electronic interface device 90 which can be of the fixed or mobile type such as a smartphone, a tablet PC and so on, or directly with alarm signalling devices (not illustrated) such as for example acoustic and/or visual signal generators. In addition or alternatively, the on-board electronic board 60 comprises a connection plug 62 for connecting to a connection cable (not illustrated) for the wired connection of the electronic board 60 to an electronic interface device 90, as described above. In addition or alternatively, the on-board electronic board 60 comprises an alarm signal source (not illustrated), preferably self-powered by battery, for example an acoustic signal source and/or a light signal source. The light signal source is preferably of the low consumption and high visibility type, such as for example a led or a stroboscopic led.

Preferably, the on-board electronic board 60 is housed in a protective shell (not illustrated) fixed to the fixing base 10. The shell is preferably made of plastic material and is configured to protect the electronic components of the on-board electronic board 60, for example from organic liquids, physical, chemical or atmospheric agents. The protective shell can, for example, have the shape of a cap or half-shell or cylindrical or semi-cylindrical.

In the embodiment of Figures 6 and 7, the fixing base 10 is advantageously made as a multilayer element, comprising an upper filtering layer 14, an intermediate layer 18 and a lower layer 15, 17. In particular, the lower layer 15,17 is preferably of the multicompartmental type, provided with a central adsorbent compartment 15 and with an adhesive peripheral compartment 17.

In particular, the upper layer 14 is made with a filtering fabric suitable for retaining the passage of microorganisms such as bacteria and viruses, preferably treated in such a way as to inhibit the proliferation of microorganisms. The upper layer 14 is also preferably made of hydrophobic material, but with good transpiring properties.

As shown in Figure 7, the upper layer 14 covers the detection device 50 and integrates the connection clamp 55, allowing the access thereof from the outside.

By way of example, the upper layer 14 is made of non-woven polypropylene (PP) fabric of the type Spunbond - Meltblown - Spunbond Nonwoven, non-woven polyester (PE) fabric or silver- filled non-woven fabric. Preferably, the upper layer 14 is made of non-woven fabric with hydrophobic, antibacterial and/or antifungal properties. Alternatively, it is possible to provide a composite upper layer 14 comprising, in addition to the non-woven fabric level, a polyurethane level which acts as an antibacterial and antiviral barrier.

The intermediate layer 18 is configured to house in its inside the detection device 50 and the electrical connection which connects the detection device 50 to the clamp 55, as well as at least partially the clamp 55 itself. The intermediate layer 18 is also configured to strengthen both the fixing base 10 and the adhesive fixing flap 20, providing support to the lower layer 15, 17. According to a preferred variant, the intermediate layer 18 is made of a microperforated material to preserve the breathability of the fixing base 10. For example, the intermediate layer 18 is made of medical foam.

As mentioned, the lower layer 15,17 comprises a first adsorbent compartment 15 preferably made in the form of a hypertonic gel or hydrocolloidal substance to adsorb the liquids that can form on the patient's skin, for example by sweating. Preferably, the first compartment 15 is made of a material permeable to water vapour, suitable for ensuring a correct passage of air and oxygen and impermeable to water and bacteria. By way of example, the first adsorbent compartment 15 is made of absorbent open cell polyurethane foam in a thin layer. Advantageously, this material also allows to adapt to any anatomical part.

The first compartment 15 of the lower layer 15,17 is made at a central area lib of the lateral portion 11 in such a way as to adhere in use to the skin of the patient.

Furthermore, the lower layer 15,17 comprises a second adhesive compartment 17 which preferably extends along the adhesive fixing flap 20 and along the perimeter of the lateral portion 11, thus leaving the central area lib of the lateral portion 11 uncovered, so that the first compartment 15 adheres directly to the patient's skin.

The second adhesive compartment 17 is preferably made of a material that can be validated with respect to the ISO 10993 standard, so that it can be used in the clinical and medical field, and preferably similar to one or more of the following known adhesive materials: 3M-MED 1522, 3M 9425HT, 3M 9629PC, 3M 9415PC and 3M 9415PC.

In alternative embodiments (not illustrated), the lower layer 15,17 can be of the single compartment type being made entirely of adsorbent material 15 with additional characteristics of good adhesion to the skin, or entirely made of adhesive material 17.

In order to ensure a fixed positioning of the fixing base 10 on the patient's skin, the fixing base 10 is preferably provided with a plurality of holes 16 which allow it to be bound to the skin by means of a suture.

Figure 8 illustrates a third embodiment of the fixing device 1 according to the present invention in which a cover element 30 configured to be positioned at the patient's mouth is bound to the fixing base 10, in case the fixing device 1 is used for fixing airway management devices or gastric tubes. The cover element 30 is configured to cover the area in which, in use, the adhesive fixing flap 20 adheres to the device. Like the upper layer 14 of the multilayer fixing base 10, the cover element 30 is also made with a filtering fabric suitable for retaining the passage of microorganisms such as bacteria and viruses.

By way of example, the cover element 30 is made of non-woven polypropylene (PP) fabric of the type Spunbond - Meltblown - Spunbond Nonwoven, non-woven polyester (PE) fabric or silver-filled non-woven fabric. Preferably, the cover element 30 is made of non-woven fabric with hydrophobic, antibacterial and/or antifungal properties. Alternatively, it is possible to provide a composite cover element 30 comprising, in addition to the non-woven fabric level, a polyurethane level which acts as an antibacterial and antiviral barrier.

With reference to Figures 9 and 10, respectively a fourth and a fifth embodiment of the fixing device 1 according to the present invention are shown which differ from the embodiment of Figure 6 in the configuration and/or position of the prolongation 11a for connecting the adhesive fixing flap 20 to the fixing base 10.

In detail, in the embodiment of figure 9, the prolongation 11a is made as a lateral extension of a portion of the long side of the adhesive fixing flap 20, connecting said long side of the adhesive fixing flap 20 to a lengthening flap 12,13 of the lateral portion 11. Also, according to this configuration, the adhesive fixing flap 20 can rotate about an axis parallel to the development axis A and passing through the prolongation 11a.

Otherwise, in the embodiment shown in Figure 10, the prolongation 1 la is placed at the centre of the short side of the adhesive fixing flap 20 and connects it to the lateral portion 11 of the fixing base 10. According to this configuration, the adhesive fixing flap 20 can rotate about its own development axis A. Furthermore, in the embodiment of Figure 10, the detection device 50 is substantially placed at the free end of the adhesive fixing flap 20, making the detection of a voltage applied to the intracorporeal access device T to which the adhesive flap 20 is bound even more sensitive.

With reference to Figures 11 and 12, a sixth embodiment is shown which is particularly suitable for fixing an intracorporeal access device of the nasotracheal access type which differs from the previous embodiments in the presence of a single lengthening flap 12 protruding longitudinally from the lateral portion 11. The lengthening flap 12 is preferably fixed between the mouth and the nose of the patient P, as illustrated in Figure 12. Note that in this way the patient’s access area - in this case the nose of the patient P - is completely free and accessible. The sixth embodiment is also particularly suitable for fixing an intracorporeal access device in the neonatal context, being able to secure at the same time both a nasotracheal access device and a gastric tube by means of a single adhesive fixing flap 20.

With reference to Figures 13 and 14, a seventh embodiment is shown particularly suitable for fixing an intracorporeal access device of the plural, nasotracheal and nasogastric access type which differs from the previous embodiments in the absence of lengthening flaps protruding longitudinally from the lateral portion 11. This seventh embodiment is particularly useful when it is not possible to position an adhesive between the nose and the mouth or under the mouth of the patient.

Finally, Figures 15 and 16 show a fixing device 1 according to the present invention used for fixing two different intrathoracic access devices.

The fixing device for intracorporeal access devices thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the attached claims. Indeed, it is clear that the above examples should not be interpreted in a limiting sense.

For example, in some advanced embodiments (not illustrated), the fixing device 1 comprises an integrated electronic signalling apparatus, integral with the fixing base 10 or integrated into the fixing base 10 or fixed thereto, which is operatively connected to the detection device 50 so as to receive therefrom the data or signals relating to the detections and/or measurements made by the detection device 50 (as a function of the traction and possibly the longitudinal displacement detected): the integrated electronic signalling apparatus comprises an electronic control device able to receive and interpret data and/or signals (for example a microprocessor or a microcontroller) and one or more acoustic and/or light signalling devices (for example LEDs, beepers, etc.).

In practice, the integrated electronic signalling apparatus performs the same functions as the electronic interface device 90 and already described with reference thereto, therefore the integrated electronic signalling apparatus is configured to provide visual and/or acoustic messages as a function of the traction detected by the detection device 50 (and possibly also of the longitudinal displacement detected).

Preferably, the integrated electronic signalling apparatus is physically connected to or integrated with the detection device 50 (for example integrated into the same electronic board); according to an optional and advantageous feature, the integrated electronic signalling apparatus is contained in a same protective shell in which the detection device 50 is also housed and is fixed to the fixing base 10.

In the preferred advanced embodiments, the integrated electronic signalling apparatus is present as an alternative to the electronic interface device 90 and therefore, in these embodiments, the data and/or signal transmission system, the fixing device 1 are not included resulting in this way lighter, more compact and easier to use. The operation of the fixing device for intracorporeal access devices is clear and evident from what has been described.

The fixing device for intracorporeal access devices thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the attached claims. Furthermore, all the details can be replaced by other technically equivalent elements. In practice, the materials used, as well as the contingent shapes and dimensions, may be any according to requirements and to the state of the art.