Device for laryngectomised persons

Abstract

The invention relates to a device (100) for laryngectomised persons, comprising a respiratory prosthesis (120) comprising an adapted tube (122) for connecting to a new incision that is made in the neck and extends to the pharynx at the base of the tongue, and comprising at least one biocompatible membrane (124) for filtering liquids and solids and preventing them from passing through the tube (122), wherein a coupler (126) for coupling to the new incision is connected internally to the distal end of the tube (122) and externally to at least one pipe (130a, 130b) for exterior communication with a tracheostoma coupler (110), which comprises a sealingly and detachably accommodated HME filter (112), such that the new-incision coupler (126) is connected to the tracheostoma coupler (110).

Description

[0001]

[0002] DEVICE FOR LARYNGECTOMIZED PEOPLE

[0003] Technology sector

[0004] The present invention is situated in the health sector and refers, more specifically, to a device that adapts to a heat and moisture exchanger (HME) filter used by laryngectomized people and that, through a new incision at the level of the base of the tongue, allows the passage of air through the oral and nasal passages through the respiratory prosthesis system - HME to the lungs.

[0005] State of the art

[0006] Total laryngectomy involves removing the entire larynx of a patient (usually as a result of surgical treatment for cancer in the larynx) and creating a surgical opening in the front of the neck in the anterior wall of the trachea followed by, and fixing it to the skin of the neck (tracheostomy), through which breathing is carried out.

[0007] Among the devices that allow for adequate breathing in the aforementioned situation are HME filters, which are designed to humidify and warm the air. Even so, to combat dryness, the bodies of laryngectomized patients produce mucus, making it necessary to change the filters once or more per day. Breathing through the stoma using an HME does not replace the benefits of mouth-nose breathing, such as the sense of smell and the production of nitric oxide (NO), which has crucial effects on arterial health by acting as a biological messenger, regulating the activity of the immune system, brain, arteries, liver, pancreas, uterus, and lungs. NO originates in the nose and paranasal sinuses and functions as a vasodilator, thus regulating blood flow and vascular function in the lungs.People who have undergone laryngectomy, since they do not have airflow in that area, do not produce it.

[0008] Furthermore, since air does not pass through the oronasal area, no sounds are produced when attempting to speak, so these patients typically use voice prostheses. Extensive research has been conducted to restore voice to laryngectomized patients since the first laryngectomy in 1873. However, no commercially available products exist to restore mouth breathing to laryngectomized patients. At the beginning of this century, the only known development to replace the larynx, restore mouth breathing, and close the tracheostomy began to be published. The ENTegral artificial larynx, designed by Christian Debry and colleagues in Strasbourg, has not yet materialized into a commercially viable product, or anything similar that reflects the same information.

[0009] Furthermore, laryngeal transplantation is not a suitable strategy for cancer patients due to the need for immunosuppression to prevent organ rejection. Therefore, it is not an option for the vast majority of laryngectomized patients (laryngectomy is only performed after significant cervical trauma).

[0010] The following documents may also be mentioned for illustrative purposes. First, reference WO2015123626 discloses a device for providing speech to a patient, wherein the device comprises a prosthesis connecting the pharynx to the trachea; preferably, said prosthesis comprises a one-way valve to prevent ingested food and / or liquid from entering the trachea. Additionally, an insufflator delivers air, and using a tube that passes through the patient's stoma to the prosthesis, the air is then passed into the patient's pharynx, enabling the patient to speak. In this invention, the prosthesis does not allow the patient to breathe through the nose / mouth, since the valve is one-way and the prosthesis is located in the patient's trachea.

[0011] Document WO2021206558 A1 discloses a system designed to restore the sense of taste and / or smell in a patient who has undergone a laryngectomy or tracheostomy. Specifically, the system comprises tubes connected, on one side, to the patient's endoscopic microsurgical unit (EMU) / stoma and on the other side to the patient's nose and / or mouth. Airflow passes through the nose, mouth, tubes, and EMU. In this system, the tubes are connected externally, directly to the user's nose or mouth.

[0012] US patent 4274162A concerns the installation, in a patient's trachea, of a device for the controlled passage of air by means of a valve. This valve would operate using gas and would include sensors to detect the presence of food or liquid in the patient's throat, preventing the passage of food and / or liquid beyond the device.

[0013] Finally, document WO2023201259 discloses an example of HME implementation from the state of the art.

[0014] The present invention provides a device that aims to mitigate at least some of the aforementioned drawbacks in a practical and comfortable manner for the patient in their daily activities, allowing neck and trunk movements to their maximum range, with easy assembly / disassembly of the device components for cleaning, replacement or repair, and offering significant improvements in taste and smell sensitivity; likewise, with this device the patient could emit sounds by pressing the HME filter button and breathe through the mouth-nose.

[0015] Object of the invention

[0016] Therefore, considering the purpose set out in the previous section, the object of the present invention is a semi-implantable medical device that allows oral / nasal breathing in laryngectomized patients, comprising three essential parts (thus differentiated for convenience): a respiratory prosthesis, a coupling to the new incision and a coupling to the tracheostomy, comprising at least one external communication tube between the coupling to the tracheostomy and the respiratory prosthesis; it may comprise one or more communication tubes, the preferred embodiment being a device with two tubes.The respiratory prosthesis comprises an adapted conduit that is housed in a stoma created by a new incision in the neck and extends to the pharynx at the level of the base of the tongue, the conduit having dimensions, shape and material suitable for connecting this new incision or new stoma, and the tracheostoma incision through the external connection between both couplings.

[0017] The respiratory prosthesis also includes at least one biocompatible membrane to filter liquids and solids, preventing them from entering the trachea. The so-called new incision attachment can be connected to the end of the respiratory prosthesis tubing located at the new neck stoma, and also to the corresponding first end of at least one communication tube. The membrane(s) are porous and allow air to pass through during inhalation and exhalation, ensuring sufficient airflow for the laryngectomized person to breathe adequately.

[0018] If there are two or more communication tubes, the coupling to the new incision can be attached to the respective ends of said two or more tubes. The so-called tracheostomy coupling has the form of a housing that embraces the HME; the HME can be any of the various types currently available on the market or that may be developed in the future specifically for the device of the invention. To this end, the tracheostomy coupling will comprise a housing to accommodate said HME filter such that it can be disassembled / assembled with respect to the housing and such that, once assembled, the assembly is airtight. The tracheostomy coupling will also include fastening means for connecting to the corresponding second end of the communication tube or tubes.

[0019] Thanks to this configuration, oral-nasal breathing is restored to people who have undergone a total laryngectomy, thereby recovering their sense of smell and taste. In addition, people who have had a voice prosthesis placed between the trachea and esophagus can continue speaking with a tracheoesophageal voice if necessary.

[0020] According to a feature of the invention, the respiratory prosthesis duct is substantially cylindrical and its length is adjustable or adaptable according to the anatomy of each patient, that is, according to the separation distance between the surface of the neck where the new incision is made and the pharynx.

[0021] According to another feature of the invention, the respiratory prosthesis conduit comprises one or more external flanges or wings at its distal end, i.e., the end furthest from the trachea. It may also comprise one or more internal flanges or wings at its other, proximal end. In one embodiment, these flanges project substantially in the direction of the radii of a cross-section of the prosthesis conduit, i.e., like the flanges of a tube, and may occupy all or part of the conduit's perimeter. In this way, they act as positioning and limiting elements, primarily for the axial movement of the conduit. Preferably, the internal flanges of the proximal end, in their operative position, end just below the reflex zone of the oral cavity, without touching it. Preferably, the flange of the proximal end comprises a suction cup-type system that rests on the pharyngeal portion.

[0022] Additionally, when the user removes the device (to eat, drink, or sleep), the implanted respiratory prosthesis remains in place. A plug is designed to fit over the prosthesis, sealing it. Its removable or easily detachable and reattached nature provides the patient with a sense of security, especially since it initially appears incompatible with simultaneous oral intake. Nighttime rest and oral intake could be suitable times to provide patients with oral breathing and olfactory support for approximately eight hours per day.

[0023] According to a further feature of the invention, the biocompatible membranes may be hydrophobic, may include a surface treatment (such as Plasma Plus® and ENDEXO®) intended to inhibit or prevent the proliferation of fungi and bacteria (or may include a material having that function), and may have a porosity that allows a sufficient number of respiratory cycles per minute to enable proper breathing. The diameter, thickness, and shape of these pores facilitate the passage of a sufficient airflow to ensure proper and comfortable breathing. The surface treatment on the membrane also promotes the flow of liquids, minimizing the amount of liquid that passes into the cavity through the membrane, thus reducing pore collapse.Each of the various membranes may have any combination of the three technical elements just mentioned, that is, it may comprise zero, one, two or three of the technical elements set out; preferably, although not exclusively, all membranes will comprise all three technical elements.

[0024] According to a further feature of the invention, the distal end of the respiratory prosthesis conduit and the distal end of the coupling to the new incision may comprise complementary magnets that achieve a firm connection between the two parts. This connection by means of magnets could also be achieved using magnets with a metal piece, or a ring-type circular magnet with a metal component. Other forms of connection, such as a clip, a twist-fit, a conical joint with friction or pressure, or similar methods, are not excluded.

[0025] These plugs will be contained or embedded within the outer fins. Therefore, the plugs do not come into contact with the patient's skin and are encapsulated, guaranteeing the user's safety in all cases of possible ingestion. Furthermore, these two pieces may include complementary lips and grooves that facilitate their correct mutual positioning, quickly and easily; that is, the lips and grooves will have complementary shapes that only allow the conduit and the connection to the new incision to be positioned in the correct orientation.

[0026] Another feature of the invention relates to the fact that the device for laryngectomized individuals may include respective adhesive strips adapted to firmly affix both the respiratory prosthesis and the tracheostomy attachment to the patient's skin. In connection with this feature, the adhesive strip intended for the respiratory prosthesis may have a shape or configuration such that, when applied to secure the respiratory prosthesis to the patient, it overlaps the aforementioned outer edges (or part thereof) and part of the patient's skin surrounding the respiratory prosthesis.

[0027] According to another feature of the invention, the biocompatible membranes of the respiratory prosthesis may be or include a hemispherical membrane (helmet-like) and a membrane angled with respect to the airflow or the longitudinal axis of the conduit. Also related to the biocompatible membranes, the conduit of the respiratory prosthesis may comprise flaps that cooperate functionally with one or more respective membranes, acting as a partial valve.

[0028] According to another feature of the invention, the proximal end of the respiratory prosthesis conduit, that is, the end closest to the trachea that is first inserted into the new stoma created in the patient, may comprise a temporary encapsulation or capsule that covers the aforementioned inner ridges and is adapted to facilitate its passage through said new stoma. In other words, the tendency will be to provide smooth surfaces, or at least surfaces without roughness or pronounced protrusions that could be harmful to the biological tissue with which they will come into contact within the patient's body; in this respect, a helmet-like or domed, smooth plug could constitute, without limitation, one of the embodiments.Furthermore, the capsule will be designed to be dissolved by the patient ingesting water and will comprise materials that are not harmful to the human body, one of the materials being collagen.

[0029] According to another additional feature of the invention, at least part of the components of the respiratory prosthesis (preferably those intended to be placed inside the human body) is made of soft materials of similar hardness to the tissues of the oronasal area, but with sufficient hardness to prevent it from collapsing due to the forces exerted by the surrounding tissues.

[0030] Another feature of the device of the present invention relates to the fact that the outer housing of the tracheostomy coupling may include a semi-rigid and / or elastic portion to which the HME filter can be assembled. The combination of rigidity and elasticity is intended to provide a tight and airtight fit between the housing and the HME filter, and also to facilitate its removal. Furthermore, the outer housing will also comprise a relatively rigid portion that allows for the secure connection of the communication tubes and proper airflow.In this regard, the coupling of the communication tubes with the respiratory prosthesis and with the tracheostomy coupling can be done using unidirectional sliding harpoon surfaces or barbs (in the style of coupling hoses to spigots or fluid outlets in different industrial sectors) or by another suitable mechanism that guarantees the integrity of the union under the usual conditions of patient mobility.

[0031] In a preferred embodiment of the invention, the rigid portion of the outer housing of the tracheostomy coupling has a substantially toroidal or donut shape and thus a central passage. This central passage is adapted to secure the aforementioned semi-rigid portion, onto which the HME filter can be mounted in a tight and leak-proof manner. The toroidal shape itself serves as a safety feature, collecting any fluid that may enter through the respiratory prosthesis at its lower portion. The outer housing also includes coupling means for communication tubes, which may be, for example, of the type described in the preceding paragraph.

[0032] According to another feature of the device for laryngectomized individuals of the invention, the commercially available adhesive solution for tracheostomy attachment comprises a lip that projects or protrudes substantially perpendicular to the patient's body surface, i.e., distally. The HME filter selected for the laryngectomy device in question fits into the inner circumferential portion of this lip, where it is secured in a leak-proof and removable manner. That is, if the HME is designed specifically for the device, the lip will be designed in accordance with the dimensions and specifications of the HME filter used.Furthermore, the tracheostomy attachment, in its operational position, will cover both the HME filter and the entire lip of the sticker; that is, if the tracheostomy attachment is toroidal in shape, an outer circumferential skirt will be provided that covers these elements up to the sticker placed on the patient's skin.

[0033] Finally, according to another feature of the invention, the radius of curvature of the communication tubes between the tracheostomy connection and the respiratory connection to the new incision is adapted to allow flexion and extension movements of the user's neck in all directions and at maximum amplitudes without causing collapse, folding, or crushing of any of the tubes that could impede airflow. To achieve this, appropriate exit angles will be selected for the connections or coupling means of said tubes, both at the tracheostomy connection and at the connection to the new incision, as well as suitable lengths, diameters, and materials for the tubes. In this regard, one of the preferred materials for these tubes is silicone reinforced with a silicone spiral.

[0034] Description of the figures

[0035] The accompanying drawings illustrate, by way of non-limiting example, embodiments of the device for laryngectomized persons according to the invention. In said drawings: Figure 1 is a perspective view of the device for laryngectomized persons according to the present invention.

[0036] Figure 2 is a sagittal section view of the device for laryngectomized persons of the present invention applied to a patient.

[0037] Figure 3 is an exploded, perspective view of part of the respiratory prosthesis of the device of the present invention.

[0038] Figure 4 is a perspective view of the coupling to the new incision which fits into the respiratory prosthesis according to the present invention, viewed from the coupling part to the duct of said prosthesis.

[0039] Figure 5 is a perspective view illustrating the combination of the respiratory prosthesis with an encapsulation, according to a practical embodiment of the present invention, for the insertion of said conduit in a patient.

[0040] Figure 6 is a side view of the tracheostomy coupling facing an HME filter assembly and corresponding sticker, on the left side of the figure, and a cross-sectional view of said tracheostomy coupling already assembled with the filter assembly and sticker, on the right side of the figure.

[0041] Figure 7 is a perspective view of the tracheostomy trade sticker partially shown in Figure 6.

[0042] Figure 8 shows different options ((a), (b), (c) and (d)) for the realization of the biocompatible membrane in relation to its coupling to the duct of the respiratory prosthesis of the present invention.

[0043] Detailed description of the invention

[0044] A detailed description of the invention will now be provided, focusing on some details not previously discussed and with reference to the listed figures. Figure 1 shows a device (100) for laryngectomized individuals according to the invention, fully assembled as it would be applied to a patient. To illustrate the final orientation of the various components in their operative position, Figure 2 shows the same device (100) from Figure 1 on the patient's body in sagittal section.

[0045] Figure 2 shows the parts comprising the device (100), with a respiratory prosthesis (120) to which is attached the coupling to the new incision (126), connecting to said coupling to the new incision (126) two tubes (130a, 130b) on both sides thereof, and with a tracheostomy coupling (110) to which the other end of the tubes (130a, 130b) is connected.

[0046] The tracheostomy coupling (110) is designed to accommodate an HME filter (112) of the type commonly used in laryngectomized patients. This filter can be of any existing or future type that has dimensions compatible with the tracheostomy coupling (110) (for example, the well-known Provox XtraFlow from ATOS). To receive this HME filter (112), the coupling (110) comprises a semi-rigid and / or slightly elastic part (116) that, once the filter (112) is mounted, secures it with a firm and airtight seal. In this regard, the simple production of part (116) in different shapes and / or configurations will facilitate the attachment of different HME filters (112) that may have varying dimensions and / or shapes. When necessary, the housing (114) can also be provided in different dimensions and shapes to accommodate different filters and adhesive labels.

[0047] In this preferred embodiment of the invention, the tracheostomy coupling (110) has a substantially toroidal shape, with the portion (116) located at the center of the toroid, embracing the outer contour of the HME filter (112) (this positional relationship between the filter (112) and the tracheostomy coupling (110) can also be seen in Figure 6). The coupling (110) is preferably designed so that the HME filter (112) can be inserted into the semi-rigid portion (116) from both sides of the toroid. This toroidal shape is not limiting; variations such as a rotated "II" shape or a dissection of the piece into two parts that fit together and are sealed by a subsequent process such as ultrasonic welding, heat, laser, or similar methods are possible, thus facilitating manufacturing by injection molding. The tracheostomy coupling (110) also comprises a rigid part (118) adapted for the connection of the communication tubes (130a, 130b).In the preferred embodiment, the device (100) comprises two tubes (130a, 130b), but in other embodiments, a single communication tube or more than two tubes (130a, 130b) may be provided. This rigid part (118) has the necessary rigidity to achieve a firm, leak-proof, and stable coupling with the tubes (130a, 130b), the latter being made of a more flexible material (such as silicone) that allows adaptation to the path from the coupling (110) to the coupling to the new incision (126) (preferably a curved path). For this purpose, the coupling (110) to the tracheostomy comprises connection ports, in this case cylindrical openings, into which the corresponding ends of the communication tubes (130a, 130b) can be coupled.This coupling can be by friction, by elastic fit (facilitated by the material of the tubes (130a, 130b), for example, silicone), by means of mechanical gripping elements (such as a surface with barbs or harpooned on the outside of the cylindrical mouths), by means of flanges or clamps, clips and the like, or any combination of the above.

[0048] The curvature of the tubes (130a, 130b), together with their constituent material, prevents the user from crushing them by bending their neck, thus preventing accidental obstruction; some of the specific design values ​​for these tubes (130a, 130b) may be an inner diameter equal to or greater than 7 mm and a shore hardness value of 50 A or less, these magnitudes being indicative.

[0049] For the correct design of the communication between the respiratory prosthesis (120) and the tracheostomy connection (110), in addition to the values ​​already mentioned, the exit angle of the cylindrical openings will also be taken into account, both in the connection to the new incision (126) and in the connection to the tracheostomy (110). All these parameters can be adjusted to ensure proper airflow through the tubes (130a, 130b), without collapse due, for example, to patient movement, and a firm connection at their ends.

[0050] Continuing with the description of the tracheostomy coupling (110), a commercial tracheostomy sticker (111) is also provided (which can also be seen in Figures 6 and 7). This sticker comprises a lip (113) designed to embrace the lower part of the HME filter (112). This is more clearly seen in Figure 6. Therefore, the tracheostomy coupling (110) is adapted to embrace or confine the lip (113), which in turn embraces the HME filter (112). This provides better protection for the entire assembly (filter (112) and sticker (111)) and an optimal aesthetic effect, as the coupling (110) extends from the upper flat part of the filter (112) to the lower part of the lip (113) and the upper part of the sticker (111) thanks to the skirt (115). This effect can be seen best on the right side of Figure 6, which depicts a section of the coupling (110) assembled on the HME filter (112) and sticker (111).

[0051] The connection between the tracheostomy coupling (110) and the HME filter (112) can be achieved by clicking, when the inner part of the skirt (115) extends beyond the wider upper part of the HME filter (112) as the former is pressed onto the latter to complete the assembly. As explained above regarding its use with any HME filter (112) that meets these dimensions, it is also anticipated that the coupling (110) will, in all cases (i.e., regardless of whether it is toroidal in shape), include an opening to facilitate pressing the speech button or mechanism of the HME filter (112) and the voice prosthesis.

[0052] The tubes (130a, 130b) connect, at their other ends, to the coupling at the new incision (126), which communicates with the respiratory prosthesis (120). This prosthesis is also connected to the oronasal area via the conduit (122) (after incisions were made between the neck and pharynx, as shown in Figure 2). This allows free passage of air between the oronasal area, improving taste and smell, while simultaneously enhancing particle filtration and humidifying the inhaled air during use. One preferred, though not mandatory, position for the conduit (122) is directly under the tongue, at its base, at the point furthest from the reflex zone of the oral cavity. Another preferred position is at the level of the upper or anterior part of the hyoid bone.

[0053] As mentioned above, the tubes (130a, 130b) communicate with the prosthesis (120), and for this purpose, a coupling to the new incision (126) (in the form of a “T” connection) is provided, which has the necessary ports for joining said tubes. In this case, corresponding to the preferred embodiment with two tubes (130a, 130b), the “T” formed by the coupling to the new incision (126) has a certain curvature or inclination at its connection ports with the tubes (130a, 130b) so as to facilitate the transfer of air in its downward path to the coupling to the tracheostomy (110), similarly to the inclination of the connection ports of said coupling to the tracheostomy (110). The integrity of the tubes (130a, 130b) and their connections to the two pieces (120, 126) is also enhanced in the event of any patient movement, as they are not forced into excessively tight bends or elbows. Preferably, the radius of curvature of the tubes (130a, 130b) is 10 mm or less.

[0054] The connection to the new incision (126) and the conduit (122) of the respiratory prosthesis (120) are preferably two separate pieces, as can be seen more clearly in Figures 3 and 4. This facilitates the assembly of the entire unit since the conduit (122) is implanted or inserted within the patient's body. To achieve correct and simple assembly of the entire unit, a lip (127a) and groove (127b) positioning mechanism and a coupling mechanism using pins (125a, 125b) are provided.

[0055] The lip (127a) and the groove (127b) make it so that the duct (122) and the coupling to the new incision (126) can only be joined with a single mutual orientation (reducing the error rate, on the part of the user, in the coupling of the two pieces) and the mandrels (125a, 125b) guarantee the strength of that union by acting to form a firm union (against flexion-extension and rotation movements of the neck).

[0056] The mechanism may comprise more than one complementary lip (127a) and groove (127b), as in the case of this embodiment, in which the wavy contour of the conduit connection area (122) forms two lips (127a) and the corresponding contour of the coupling to the new incision (126) forms two respective grooves (127b). The curved shape of said lip (127a) and groove (127b) is illustrative, and a lip or protrusion and a groove or housing with any other complementary shapes may be provided.

[0057] In one of the preferred embodiments, the internal diameter of the conduit (122) is substantially 9 mm; this value provides a cross-sectional area greater than that of the most commonly used LaryTube (tracheostomy opening), which is 24 Fr. On the other hand, by varying the characteristics or the number of pins (125a, 125b) in the structure, the uncoupling force can be controlled so as not to compromise the integrity of the tissue and so that, at the same time, this operation can be easily performed by the user, but without the separation of the two pieces (122, 126) occurring accidentally.

[0058] In Figure 3 the inner (129) and outer (128) edges can be seen more clearly (the latter are hidden in Figure 1 as they are covered by the sticker

[0059] (123) for securing to the patient's skin). The flanges (128) are in contact with the external part of the body, allowing for a less invasive insertion compared to the insertion of known voice prostheses. The initial insertion, performed in the operating room, will be carried out using a specially designed insertion device, and subsequent replacements will be performed by encapsulating the respiratory prosthesis on an outpatient basis. The location of the respiratory prosthesis (120) allows for cleaning by the user, thus extending its lifespan. Furthermore, as is clearly shown, the respiratory prosthesis (120) does not replace the tracheostomy opening; therefore, in cases of cleaning or sudden obstruction, the patient will still have access to air through the tracheostomy.The shape and arrangement of the rims (128, 129) are merely illustrative and may differ from those represented provided they perform their function of restricting movement as set out in the claims.

[0060] The device (100) also comprises a biocompatible membrane (124) with a degree of porosity sufficient to prevent solids and liquids from entering the respiratory prosthesis (120), while allowing air to pass through. This is due to its sieve-like or mesh-like shape and the minimal pore size, which permits airflow in both directions (from the oronasal area to the lungs during inhalation, and from the lungs to the oronasal area during exhalation). In one version of the device (100) related to the fixation of the membrane (124) in the duct (122), a sleeve (121) is provided as a means of securing the membrane.

[0061] (124) This fixation can be by friction (adjusted by means of protruding elements or by the complementary geometry of the sleeve (121), the conduit (122), and the membrane (124)) or, for example, threaded, by way of illustration. In this respect, both the membrane (124) and the sleeve (121) are made of a material of a nature, configuration, and external shape such that they prevent breakage and deformation during the insertion procedure into the patient's body; that is, they are made of a material flexible enough to adapt to the characteristics of the tissue in that area of ​​the human body, so as not to cause discomfort, damage, or injury, but with sufficient rigidity and consistency to prevent breakage, detachment of parts, or deformations that could be detrimental to the patient's physical integrity.The membrane (124) is adapted to be sterilized and manufactured in large quantities for industrial production; it is susceptible to manufacture using 3D printing and / or 3D FDM techniques, although other mass production methods are also considered, as well as the alternative use of commercial membranes.

[0062] Figure 5 shows an embodiment comprising an encapsulation or capsule (140) intended to be placed over the proximal end of the duct (122) when it is to be reinserted into the incisions made in the patient. The function of this encapsulation (140) is to facilitate this reinsertion by forming a temporary covering that provides smooth, protruding surfaces and prevents contact of the flanges (129) with corresponding parts of the user's tissue. This facilitates folding of the flange (129) and its wings for comfortable and easy passage through the stoma with less friction. Therefore, in one embodiment, the encapsulation material (140) comprises collagen and / or collagen-derived material, which can be easily diluted with water.In other variations, the encapsulation material (140) may be different, provided it meets the requirement of being water-soluble and not having harmful effects on the human body. Furthermore, the use of an insertion tool or device, such as the one mentioned above, is provided to facilitate the introduction of the system through the stoma. Alternatively, an accessory equipped with a mechanical system that allows the prosthesis to be attached during reinsertion is provided.

[0063] According to another embodiment of the invention, the respiratory prosthesis (120) comprises a vibrating element, such as a diaphragm, which, when activated and in conjunction with the exhalation phase, improves voice quality. This eliminates the need for a voice prosthesis previously required for a laryngectomized person to speak.

[0064] It is planned that any or all of the components of the respiratory prosthesis (120) will be made of materials with a hardness similar to that of the tissues of the oronasal area; “similar” in this case means equal to or slightly greater than that of the tissues, such that its greater rigidity will not cause injury or discomfort to these tissues, or slightly less so that its greater flexibility will not cause it to lose its shape and configuration necessary to perform the functions for which these components are intended. Furthermore, the manufacturing of the different elements, in their biocompatible state, is also planned to be biodegradable, facilitating their recycling and even composting, thus promoting sustainability, primarily because these are disposable elements with a short lifespan (months to a year).

[0065] Regarding the sequence for assembling the tracheostomy coupling (110), the HME filter (112), and the sticker (111), at least the following two are considered: a) First, the sticker (111) is attached, then the HME filter (112) is attached to the sticker, and finally the coupling (110) is attached to the tracheostomy (110). b) First, the sticker (111) is attached, then the tracheostomy coupling (110) is attached to the sticker (111), and finally the HME filter (112) is attached to the entire assembly.

[0066] To disassemble the three pieces, first remove the filter assembly (112) and tracheostomy coupling (110) from the sticker (111), and then remove the filter (112) from the tracheostomy coupling (110).

[0067] Figure 8 shows four possible illustrative configurations of the membrane (124). In the first, (a), a loose, semi-spherical or substantially domed membrane (124) is shown on the left, mounted in the duct (122) on the right; the concave portion of the dome could be mounted in the direction shown in the figure or in the opposite direction. In the second option, (b), a membrane (124) is shown at an angle to the longitudinal axis of the duct (122) or to the airflow. Option (c) shows a combination of two membranes (124) (which can be exactly the same or have different material characteristics, porosity, etc.); if convenient, a larger number of membranes (124) could be mounted. Finally, option (d) shows a membrane (124) combined with a reed (150).As mentioned at the beginning of this paragraph, these configurations are merely illustrative, and an indefinite number of options could be designed, provided they conform to the characteristics claimed in the relevant clauses. Likewise, the position of the membrane or membranes (124) in the airflow / swallowing path can be any position, as long as it performs its filtering function.

Claims

CLAIMS 1. Device (100) for laryngectomized persons comprising a respiratory prosthesis (120) comprising a conduit (122) adapted to connect a new incision in the neck to the pharynx at the level of the base of the tongue, and comprising at least one biocompatible membrane (124) for filtering liquids and solids with respect to the interior of the conduit (122), a coupling being connected to the new incision (126) on its inner side to the distal end of the conduit (122), and on its outer side connected to at least one tube (130a, 130b) for external communication to a tracheostomy coupling (110) comprising a watertight and detachable HME filter (112), such that said coupling is connected to the new incision (126) to the tracheostomy coupling (110).

2. Device (100) for laryngectomized persons according to claim 1, wherein the duct (122) of the respiratory prosthesis (120) is cylindrical and / or of adjustable length to the anatomy of each patient.

3. Device (100) for laryngectomized persons according to any of the preceding claims, wherein the conduit (122) of the respiratory prosthesis (120) comprises at least an outer flange (128) at its distal end and / or at least an inner flange (129) at its proximal end, adapted to restrict the axial movement of said conduit (122).

4. Device (100) for laryngectomized persons according to any of the preceding claims, wherein at least one of the membranes (124): - is hydrophobic and / or - comprises a surface treatment and / or a prepared material(s) to inhibit the proliferation of fungi and bacteria and / or - It has a porosity that allows a sufficient number of cycles per minute to allow proper breathing, and allows air to pass through bidirectionally but without allowing liquids or solids to pass through.

5. Device (100) for laryngectomized persons according to any of the preceding claims, wherein the distal end of the conduit (122) and the inner part of the coupling to the new incision (126) comprise: - respective complementary manes (125a, 125b), encapsulated and / or fitted into corresponding housings, and suitable for firmly joining the conduit (122) with the coupling to the new incision (126), and / or - at least one complementary lip (127a) and groove (127b) to correctly position the coupling to the new incision (126) with respect to the duct (122).

6. Device (100) for laryngectomized persons according to any of the preceding claims, comprising a sticker (123) for a respiratory prosthesis, adapted to firmly fix the respiratory prosthesis (120) to the patient's body, and / or a sticker (111) for a tracheostomy attachment, adapted to firmly fix the tracheostomy attachment (110) to the patient's body.

7. Device (100) for laryngectomized persons according to the preceding claim, wherein the respiratory prosthesis sticker (123) is adapted so that, in its operative position, it overlaps at least part of the outer rim(s). (128) and on the patient's skin.

8. Device (100) for laryngectomized persons according to any of the preceding claims, wherein the membrane or membranes (124) comprise at least one of a hemispherical membrane and a membrane installed at an angle with respect to the airflow or the longitudinal axis of the duct (122).

9. Device (100) for laryngectomized persons according to any of the preceding claims, wherein the duct (122) comprises one or more reeds (150) operatively associated, respectively, with one or more corresponding membranes (124).

10. Device (100) for laryngectomized persons according to any of the preceding claims, wherein the proximal end of the duct (122) comprises an encapsulation covering at least the inner rim or rims (129), said encapsulation being adapted, in terms of geometry and external dimensions, to facilitate its passage through a corresponding incision and being composed of bioabsorbable and water-soluble material.

11. Device (100) for laryngectomized persons according to any of the previous claims, wherein at least part of the components of the respiratory prosthesis (120) is made of soft materials of similar hardness to the tissues of the oronasal area.

12. Device (100) for laryngectomized persons according to any of the preceding claims, wherein the outer casing (114) of the tracheostomy coupling (110) comprises a semi-rigid and / or elastic part (116) adapted to receive the HME filter (112) in a detachable, tight and airtight manner and a rigid part (118) to ensure the airflow in relation to the tube (130a, 130b).

13. Device (100) for laryngectomized persons according to the preceding claim, wherein the rigid part (118) of the outer casing (114) of the coupling (110) has a substantially toroidal shape and comprises coupling means for the tube (130a, 130b), the central passage of said toroidal shape being adapted for the firm fixation of the part (116), which in turn comprises a central through opening for the detachable, tight and watertight coupling of the HME filter (112).

14. Device (100) for laryngectomized persons according to the preceding claim, wherein the tracheostomy attachment sticker (111) comprises a distally projecting lip (113) adapted to fit snugly, watertightly and detachably into a proximal portion of the HME filter (112), and the outer casing (114) comprises a circumferential skirt (115) which, in its operative position, covers the entire outer circumferential perimeter of the HME filter (112) and the lip (113) of the tracheostomy sticker (111) up to the patient's body.

15. Device (100) for laryngectomized persons according to any of the preceding claims, wherein: - the radius of curvature of the tube (130a, 130b) allows flexion-extension movements of the user's neck in all directions and maximum amplitudes without causing a collapse of any of the tubes that would impede the passage of air, and / or - the tube material (130a, 130b) comprises silicone.

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