WO2023227821A1

WO2023227821A1 - Phonation system for laryngectomized patients

Info

Publication number: WO2023227821A1
Application number: PCT/ES2023/070347
Authority: WO
Inventors: Alex Brustenga Regard
Original assignee: Alex Brustenga Regard
Priority date: 2022-05-26
Filing date: 2023-05-26
Publication date: 2023-11-30
Also published as: ES2956959A1

Abstract

The invention relates to a phonation system (100) for laryngectomized patients, based on vocalizing words while at the same time blowing air into the mouth by means of a suitable mouthpiece, from a certain distance. This causes the mouth to act like a sound box, resulting in a low-volume but audible, intelligible, and recognizable voice. The device is simple and low-cost and can be suitable for most patients who have not been able to recover any form of speech by means of the methods previously known.

Description

PHONATION SYSTEM FOR LARYNGECTOMIZED PATIENTS

TECHNIQUE SECTOR

The present invention belongs to the medical sector, and more specifically to the medical rehabilitation sector.

The main object of the present invention relates to a speech aid or a speech assist device for laryngectomy patients.

Laryngectomy, or laryngectomized, patients are those whose larynx or vocal cords have been removed and they breathe through a stoma in the trachea.

It can be due to various reasons, but the most common is cancer. The consequences of this operation on the patient's life are important and possibly the worst is the loss of the ability to speak. This can be devastating due to the loss of the ability to communicate easily with others.

BACKGROUND OF THE INVENTION

There are four known forms of oral communication for laryngectomized patients. The first and oldest is esophageal or erygmophonic speech, which consists of articulating words by expelling the air previously introduced into the esophagus. It is a technique that requires a long learning curve and many patients never master it. The second is through a so-called phonatory prosthesis, which is implanted by communicating the trachea with the patient's esophagus through a valve, allowing the passage of air to the pharynx and mouth. It produces speech of reasonable quality, but has the drawbacks of being expensive, requiring regular checks and replacements, risk of possible infections, and is not suitable for all patients, such as those with esophageal stricture. The third is through a device called artificial larynx whose operation is based on introducing a tube into the patient's mouth through which the expired air arrives and which has passed through a chamber in which there is a membrane or tongue that vibrates and produces sound. It is not on the market, possibly because it has been replaced by the so-called “electronic larynx” or “electrolarynx”, the fourth form of oral communication for a laryngectomized patient, in which the vibration is produced electrically and the sound generated is conducted through a tube inside the mouth or is transmitted by contact when pressing with the device in certain neck areas. The speech achieved in this way does not satisfy its users too much because it does not resemble natural human speech, but rather sounds like an electronic or robotic voice.

Despite the different options above, a significant percentage of patients never recover any form of speech.

EXPLANATION OF THE INVENTION

It is an object of this invention to provide a solution that allows patients, after a laryngectomy operation, to possess a reasonably natural and intelligible voice.

This is achieved by vocalizing the words while blowing air into the mouth, using a suitable mouthpiece held by the user's hand, from a certain distance. This causes the mouth to act as a sounding board, resulting in a low-volume, but audible, intelligible and recognizable voice. It is similar to the whispered voice with the difference that it is obtained with air blown from the outside instead of air exhaled from inside the body.

As an indication but in no way limiting, it is considered that the best results are obtained with a nozzle that at its end has an outlet hole (1) with a section between 0.8 and 7 mm2, which is equivalent to a diameter of between 1 and 3 mm, with an optimal distance between 3 and 4 mm2, and to speak at a distance of between 1 and 6 cm from the mouth, the optimal distance being between 2 and 4 cm.

The phonation system of the present invention allows laryngectomized patients to direct exhaled air through a patient's stoma or cannula towards their own mouth, which acts as a sounding board, thus allowing them to vocalize and communicate orally. The phonation system comprises a proximal end, a distal end and a tube. The proximal end further comprises an inlet orifice, and the distal end comprises an outlet orifice. Said phonation system is configured to connect at its proximal end with the patient's cannula or stoma to receive the air exhaled by the patient and direct it, through a tube, towards the exit orifice of the system, located at the distal end of the same. Preferably, the outlet hole has a diameter smaller than the inner diameter of the tube section, more preferably the diameter of the outlet hole is between 2.7 and 14 times smaller than the inner diameter of the tube section. This The air emitted through the exit orifice obtains the necessary speed to reach the inside of the mouth by placing the distal end of the phonation system a few centimeters from the patient's mouth, which allows the patient to articulate sounds and pronounce words.

Furthermore, the phonation system comprises a lateral hole between its distal and proximal ends, which, when uncovered, allows the entry and exit of air during the patient's breathing. This lateral hole, when it is covered, for example by placing one or more fingers on it, allows all the air exhaled through the system to be directed towards the exit hole, and from there towards the patient's mouth to perform the phonation function. . Preferably, the side hole has an area or diameter similar to the area of the tube section or the internal diameter of the tube.

The phonation system may comprise a mouthpiece located at the distal end. In this way, the distal end of the phonation system can be shaped like a mouthpiece. Alternatively, the nozzle may be an additional element incorporated into the system, where said nozzle is connected to the system through the proximal end of said nozzle. Said mouthpiece comprises the outlet hole at its distal end, preferably to expel air towards the patient's mouth. Preferably, the area or inner diameter of this outlet hole is of a smaller area or diameter than the area or inner diameter of the tube section.

The phonation system may further comprise a connector located at its proximal end, so that the proximal end of the phonation system may be in the form of a connector. Alternatively, the splice piece may be an additional element incorporated into the system, wherein said splice piece is configured to be connected to the system via the distal end of said piece. Furthermore, said connector may be configured to connect to the patient's cannula or stoma through its proximal end. Preferably the cannula or stoma is located in the front of the patient's neck. Note that the cannula or stoma located in the front part of the patient's neck also communicates with the interior of said patient's trachea through a surgical opening in said trachea.

In one aspect, a device is described that allows speaking through this procedure using the air expelled through the user's stoma. It is especially advantageous that the system of the invention comprises in one of its simplest versions three parts: 1) a connecting piece (Fig. 3 and 4) to attach to the stoma or the cannula therein. Could have different shapes to be able to connect in a tight way with the stoma or the different models of cannulas on the market. 2) a flexible tube that will conduct the exhaled air and 3) a mouthpiece (Fig.2) through which this air will be directed towards the mouth. This nozzle will have, in addition to the hole at its end for the air outlet (1), another of larger diameter on one side (2), with a section similar to that of the flexible tube, through which the air can enter and exit for the user's breathing. The section of the flexible tube will be ideal so that the user can breathe easily. Usually an inner diameter of between 8 and 14 mm will be sufficient. To speak, you only have to plug the side hole (2) with the tip of a finger, directing the air towards your mouth through the hole at the end of the mouthpiece (1).

On the other hand, the tube of the phonation system of the invention may comprise a flexible material. Preferably, the tube of the phonation system of the invention is flexible.

The mouthpiece of the phonation system may comprise a recess in its proximal end, configured to connect with the distal end of the tube. Preferably, the nozzle is connected by the recess at its proximal end to the distal end of the tube. .

Likewise, the connector of the phonation system may also comprise a recess in its distal end, configured to connect with the proximal end of the tube. Preferably, the connector is connected by the recess at its distal end to the proximal end of the tube.

In a preferred embodiment, the side hole of the phonation system is included in the mouthpiece. Alternatively, the lateral hole of the phonation system may be included in the connector, or in the tube.

The phonation system of the invention may further comprise a check valve located on the lateral orifice, so that it is not necessary to manually block said lateral orifice to exhale air through the outlet orifice of the phonation system or to inhale through the lateral hole, since the check valve allows the passage of air during inhalation and cuts off the passage of air through said lateral hole during exhalation.

Additionally, the system may comprise a relief valve. This allows the passage of air during exhalation if it exceeds a certain pressure threshold, and blocks the passage of air when the exhalation does not exceed the determined pressure threshold, for example, when you want to direct the exhalation towards the exit orifice ( 1) of the system to perform phonation. Said check and discharge valves may be included in the connection piece. Alternatively, said check and discharge valves may be included in the tube or mouthpiece of the speech system.

The phonation system of the invention may further comprise a housing for a filter element. Preferably said housing for a filter element is located in the connection piece. Preferably the housing is configured for a filter element capable of filtering impurities, dust and/or pathogens. Even more preferably the housing is configured for a filter element capable of filtering the air inhaled by the patient. Also, preferably the housing is configured for a filter element capable of exchanging heat and moisture between exhaled air and inhaled air. Furthermore, the phonation system of the invention may comprise any of said filter elements. Even more preferably said filter element is located in the connection piece.

A second, more advanced version incorporates, in the connection piece that is attached to the stoma or cannula, a check or non-return valve (6), which allows air to enter but not exit, and a discharge valve ( 7), which performs the inverse function starting from a certain pressure. In this case, the mouthpiece will only have the hole at its end (1), not requiring the side hole (2) for breathing since inspiration will be carried out through the check valve (6) and expiration through the discharge valve (7). ) when not speaking. Both versions can also have a housing in which an element can be placed to filter the air (5).

To be able to be disassembled and easy to clean, the nozzle and the connection piece may be inserted under pressure into the flexible tube through the recesses for this purpose.

In some cases, or for patients with breathing difficulties, you can consider using air from an external source, such as a compressor or a compressed air cylinder, appropriately regulated, to obtain the same results. Preferably, the phonation system is further configured to be able to connect said external air source at its proximal end.

Likewise, the placement, next to the mouthpiece, of a microphone, connected to an amplifier, wired or wirelessly, can be considered in order to increase the volume of speech in noisy environments or for people with hearing impairment. In addition, the amplifier may contain elements in its electronic circuit to improve or modulate the sound and make it more understandable when necessary. Furthermore, the system may comprise a processing unit configured to electronically process the signal received at the microphone.

To allow both hands to be used while speaking, the mouthpiece may be supported by a flexible ring that goes around the back of the head above the ears. The phonation system may also have other fixing means such as a rubber band, an elastic band, a belt or a clamp to be able to fix it to the head, neck, ears, the patient's clothing or to the cannula itself or to the connecting piece. .

The phonation system may also comprise an elongated and malleable element inside, configured to change shape when a force is applied to it and retain its shape when force is no longer applied to it. Preferably, said elongated and malleable element comprises a malleable material, more preferably it comprises a metallic element, a metallic alloy, or a malleable plastic material.

BRIEF DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, a set of drawings is attached as an integral part of said description, where, with an illustrative and non-limiting nature, the following has been represented. following:

Figure 1 - Image of the use of the device according to one or more preferred embodiments of the invention.

Figure 2 - Shows a section of the mouthpiece, where (1) is the air outlet hole, (2) is the breathing hole, and (3) is the recess to press fit into the flexible tube.

Figure 3 - Shows a section of the connection piece to the stoma or cannula where (4) is the part that connects to the stoma or cannula and (3) is the recess to press fit into the flexible tube.

Figure 4 - Shows a section of the connection piece to the stoma or cannula in its most evolved version, where (4) is the part that connects to the stoma or cannula, (5) is the element to filter the air, ( 6) is the check valve, (7) is the discharge valve, and (3) is the recess to press fit into the flexible tube. DETAILED EMBODIMENT OF THE INVENTION

As already indicated, and as can be seen in Fig. 1, the phonation system for laryngectomized patients, in a preferred embodiment, comprises a flexible pipe, which can be about 40 cm in length and about 12 mm in diameter. interior, with, at one end, a connecting piece (Fig.3) to connect to the cannula or stoma, and, at the other end, a nozzle (Fig.2) through which the expired air will be blown towards the mouth through the hole (1), 3 or 4 mm2 in section. In this mouthpiece there is also a side hole (2), with a section of about 100 mm2, so you can breathe through it when not speaking. These pieces can be made of various materials, but preferably they will be made of plastic or silicone or similar material.

In another preferred embodiment of the present invention, the phonation system (100) for laryngectomized patients comprises a proximal end (101), a distal end (102) and a tube (20), as can be seen in Fig. 1. The proximal end (101) comprises an inlet hole (33) and the distal end (102) comprises an outlet hole (1). Preferably, the area or diameter of the inlet hole (33) is similar to the area or internal diameter of the tube section (20), although in other embodiments said inlet hole (33) may be larger or smaller than the area or the internal diameter of the tube section (20), respectively. Said phonation system (100) is configured to connect at its proximal end (101) with a cannula or stoma of the patient, where preferably the cannula or stoma is located in the front part of the patient's neck, and also said system (100) It is configured to direct the exhaled air from the cannula or stoma towards the outlet hole (1) of the distal end (102) of the system (100) through the tube (20), preferably to direct the air towards the patient's mouth. Note that the cannula or stoma located in the front of the patient's neck communicates with the inside of the patient's trachea through a surgical opening in the trachea. In a preferred embodiment, "stoma" is understood as an artificial opening in the front of the patient's neck that is surgically created through a tracheostomy or a total laryngectomy, to allow breathing through said opening. Likewise, in a preferred embodiment, "cannula" is understood as a medical device used to keep the patient's stoma open. The phonation system (100) also comprises a lateral hole (2) located between the proximal end (101) and the distal end (102) of said system, in such a way that this lateral hole (2) allows air circulation when It is uncovered, allowing air to enter during the patient's inhalation and air to escape during exhalation. On the other hand, when this side hole (2) is blocked, for example by placing one or more fingers over said hole (2), the air exhaled by the patient only comes out through the outlet hole (1) located at the end. distal (102) of the device (100), and in this way phonation can be performed by directing said air towards your mouth with the appropriate pressure and speed. Preferably, the side hole (2) has a diameter similar to the internal diameter of the tube (20).

Alternatively, the side hole (2) has a diameter larger than the internal diameter of the tube (20). Preferably the side hole (2) has a diameter between 1.4 and 50 times larger than the diameter of the outlet hole, more preferably between 2.7 and 14 times larger than the diameter of the outlet hole (1). The person skilled in the art can find an area or a diameter of the lateral orifice that allows the patient to breathe comfortably, such as an area or a diameter such that its surface plus the surface of the exit orifice (1) is similar to the section internal of the tube (20).

It is noted that when the side hole (2) does not have a circular shape, the person skilled in the art can calculate an equivalent size for the side hole (2) such that the area of the side hole (2) is equivalent to the area of a circular hole with the necessary diameter. Likewise, when the tube (20) does not have a circular internal section, the person skilled in the art can calculate an equivalent size for the internal section of the tube (20), such that the area of the internal section of the tube (20) is equivalent to the area of a circular section with the necessary diameter. The equivalences of the relationships between the lateral hole (2) and the internal section of the tube (20) when the area is used instead of the diameter can be easily found by the person skilled in the art.

Preferably, the distal end (102) of the system (100) comprises an outlet orifice (1) with an interior section smaller than the section of the tube (20), so that, using a basic principle of fluid dynamics, when the section through which a fluid travels, in this case air, the pressure increases and with it the speed of the fluid or air increases. In this way, the air emitted through the outlet orifice (1) obtains the necessary speed to reach the interior of the mouth even while maintaining the distal end (102) of the system at a certain distance from the patient's mouth. Preferably the diameter of the outlet hole (1) has a value between 0.1 and 10 mm, more preferably between 1 and 3 mm, even more preferably the Exit hole size is between 2 and 2.26 mm. Preferably the area of the exit hole (1) has a value between 0.01 and 79 mm ² , more preferably between 0.8 and 7 mm ² , even more preferably the size of the exit hole is between 3 and 4 mm ² . Preferably, the diameter of the outlet hole (1) is between 1.4 and 50 times smaller than the diameter of the interior of the tube section (20). More preferably the diameter of the outlet hole (1), between 2.7 and 14 times smaller than the inner diameter of the tube section (20). Preferably, the inner diameter of the tube section (20) has a value between 0.2 and 5 cm, more preferably between 0.5 and 3 cm, even more preferably between 0.8 and 1.4 cm. Preferably, the section area of the tube (20) has a value between 0.03 and 20 cm ² , more preferably between 0.2 and 7 cm ² , even more preferably between 0.5 and 1.5 cm ² .

It is noted that when the exit orifice (1) does not have a circular shape, the person skilled in the art can calculate an equivalent size for the exit orifice (1) such that the area of the exit orifice (1) is equivalent to the area of a circular hole with the necessary diameter. Likewise, when the tube (20) does not have a circular internal section, the person skilled in the art can calculate an equivalent size for the internal section of the tube (20), such that the area of the internal section of the tube (20) is equivalent to the area of a circular section with the necessary diameter. The equivalences of the relationships between the outlet orifice (1) and the internal section of the tube (20) when the area is used instead of the diameter can be easily found by the person skilled in the art.

On the other hand, the phonation system (100) of the invention is configured to perform its phonation function by keeping the exit hole (1) at a distance preferably between 0.5 and 15 cm from the patient's mouth, more preferably at a distance of between 1 and 6 cm from the mouth, even more preferably at a distance of between 2 and 4 cm.

Note that the phonation system is prepared to receive the air exhaled by the patient through a hole or stoma located in the front part of the patient's neck, in particular in the trachea, where a cannula can generally be installed. In this way the system can be configured to connect with the stoma and/or the patient's cannula. Likewise, it is possible that the air received by the system comes from another source, in which case the person skilled in the art could adapt the proximal end (101) of the system to fit said other air source in an obvious way. The dimensions of the proximal end (101) of the system (100) are suitable for connecting with the patient's stoma or cannula, and therefore will depend on their size, which generally can range between 0.5 and 3 cm. The dimensions of the tube can also be variable and adapted to the patient's preferences or needs. Preferably, the inner diameter of the tube section (20) has a value between 0.2 and 5 cm, more preferably between 0.5 and 3 cm, even more preferably between 0.8 and 1.4 cm. Preferably, the section area of the tube (20) has a value between 0.03 and 20 cm ² , more preferably between 0.2 and 7 cm ² , even more preferably between 0.5 and 1.5 cm ² .

The length of the tube (20), in turn, is also adaptable to the particular characteristics of the patient. Preferably the length of the tube (20) can take a value between 2 and 60 cm, more preferably the length of the tube (20) can take a value between 3 and 30 cm, even more preferably between 5 and 15 cm. For example, in a preferred embodiment, the length of the tube may be 40 cm. The dimensions of the area or diameter of the side hole (2) may vary depending on the part of the system (100) where it is located, for example, they may depend on the size of the area or the inner diameter of the tube (20), or the nozzle (10) or the connection piece (30) if you have these.

The dimensions of the area or the side hole (2) may also vary depending on the locking mechanism used in the device, for example, they may be adapted to the size of one or more fingers. Preferably the dimensions of the area or diameter of the side hole are similar to the dimensions of the area or internal diameter of the tube (20). Preferably, the diameter of the side hole has a value between 0.2 and 5 cm, more preferably between 0.5 and 3 cm, even more preferably between 0.8 and 1.4 cm. Preferably, the area of the side hole has a value between 0.03 and 20 cm ² , more preferably between 0.2 and 7 cm ² , even more preferably between 0.5 and 1.5 cm ² . The lateral hole (2) may have circular symmetry or any other type of symmetry, and may also be irregular or comprise two partially overlapping holes to better adapt to the use of two fingers to block said hole (2). Likewise, the person skilled in the art can find various ways to plug said hole (2) in addition to using his fingers, the system (100) being able to have a lid or other opening and sealing mechanism, for example a sliding door or a manual valve, so as not to have to directly expose the skin of the fingers to the contact of the air and the interior of the tube (20), thus avoiding any type of contamination.

Note that the dimensions represented in Fig. 1 are illustrative only and should not be interpreted as a scale representation. In this way, the tube (20) can be shorter or longer, or wider or thinner, as long as it performs the function of adequately transporting the exhaled and inhaled air. Note also that in Fig. 1 a nozzle (10) is represented at the distal end (102) of the system (100) and a piece of splice (30) at the proximal end (101) of the system (100). However, these are not necessary in the system, since the system can be formed in a single piece, comprising a proximal end (101) configured to connect with the patient's cannula or stoma, and comprising a distal end (102) configured to have a smaller area or inner diameter in the outlet hole (1) than the area or inner diameter of the tube section (20), preferably between 1.4 and 50 times smaller than the inner diameter of the tube section (20). 20), or an area equivalent to a circle with said diameter, more preferably between 2.7 and 14 times smaller. For example, it may be that the system comprises a tube (20) configured to join at its proximal end with the patient's stoma or cannula, and comprise an exit hole (1) at its distal end of smaller inner diameter, or an area equivalent to a circle with said diameter, than the section of the rest of the body of the tube (20), preferably between 1.4 and 50 times smaller than the inner diameter of the section of the tube (20), or an area equivalent to a circle with said diameter, more preferably between 2.7 and 14 times smaller. That is, the distal end (102) of the phonation system (100) may be in the form of a mouthpiece (10), and the proximal end (101) of the phonation system (100) may be in the form of a connector (30), without needing additional parts.

Note that the quantities mentioned may vary within a 30% margin, that is, each diameter or length mentioned above, and each aspect ratio, may vary 30% more or 30% less than indicated above. Preferably, this margin is ±20%, more preferably it is ±10%, even more preferably it is ±5%.

Advantageously, the presence of these technical characteristics in the phonation system (100) of the invention, in particular i) the presence of a proximal end (101) configured to connect to the cannula or stoma of the patient, i) the presence of the tube (20) to conduct the inhaled and exhaled air, iii) the presence of the distal end (102) with the outlet orifice (1) configured to direct the air with the pressure and speed necessary to be able to perform phonation, and iv) The lateral hole (2) to be able to breathe without difficulties when phonation is not performed, allows the patient to perform phonation and communicate in a simple way. Furthermore, said system (100) allows the patient to speak by plugging the side hole (2), and breathe without difficulty by unblocking said hole (2), thus giving the advantage of being able to communicate and breathe effectively, through a system phonation (100) simple and easy to use. The speaking system (100) of the invention also has the advantage of not needing to be inserted in the mouth, therefore, when used at a certain distance from the mouth, it avoids the great discomfort caused by having a tube inserted in the mouth when speaking. In another preferred embodiment of the invention, the phonation system (100) comprises a mouthpiece (10) at its distal end (102), as can be seen in Figs. 1 and 2. Said mouthpiece (10) comprises an outlet hole (1) at its distal end (12) to expel air, preferably towards the patient's mouth. Preferably the nozzle (10) is joined at its proximal end to the distal end of the tube (20). Note that the dimensions of the nozzle (10) can vary depending on the dimensions of the tube (20), as well as the shape can be adapted to have a better or more comfortable grip. Preferably the diameter of the outlet hole (1) is between 1.4 and 50 times smaller than the inner diameter of the tube section (20 more preferably it is between 2.7 and 14 times smaller. Preferably the diameter of the outlet hole (1) 1) has a value between 0.1 and 10 mm, more preferably between 1 and 3 mm, even more preferably the size of the exit hole is between 2 and 2.26 mm. Preferably the area of the exit hole (1) has a value between 0.01 and 79 mm ² , more preferably between 0.8 and 7 mm ² , even more preferably the size of the exit hole is between 3 and 4 mm ² .

Note also that Figs. 1 and 2 are merely illustrative, and do not represent the nozzle (10) or other parts of the system (100) on a real scale, and the dimensions and shape of the nozzle (10) may be different from what is represented. For example, the nozzle (10) in Figs. 1 and 2 has a curved distal end (12) to facilitate the redirection of exhaled air towards the patient's mouth, particularly as the system (100) is held by the patient's hand. However, in other embodiments the distal end of the system (102), or the distal end of the nozzle (12) may not be curved, but may be straight, or may be more or less curved than represented in Figs. 1 and 2. Preferably the nozzle (10) can be separated from the rest of the system (100), more preferably from the tube (20). Preferably, the nozzle comprises a rigid material, such as, but not limited to, materials plastics, PVC, polypropylene, polyethylene, acrylic, metal elements or alloys. In a preferred embodiment, "nozzle" is understood as a component that is used to control or direct the flow of air through a duct.

The quantities mentioned may vary with a margin of 30%, that is, each area diameter or aspect ratio may vary 30% more or 30% less than indicated above. Preferably, this margin is ±20%, more preferably it is ±10%, even more preferably it is ±5%.

Advantageously, the presence of a mouthpiece (10) with a small outlet hole (1) allows air to be expelled from the system with the appropriate pressure and speed to be able to reach the inside of the mouth and allow the patient to speak. Furthermore, the presence of a nozzle (10) independent of the system (100) allows its disassembly and thus allows easy access for cleaning. On the other hand, the rigidity and curved shape of the mouthpiece are ideal for directing exhaled air towards the patient's mouth with their own hand.

In another preferred embodiment of the invention, the phonation system (100) of the invention comprises a splice piece (30) at its proximal end (101) as can be seen in Figs. 1, 3 and 4. where said connecting piece (30) is configured to connect to the patient's cannula or stoma, preferably located in the front part of the patient's neck, through its proximal end (4), where said proximal end ( 4) comprises an entry hole (33) which has a suitable shape to connect with the patient's cannula or stoma. Note that the cannula or stoma located in the front of the patient's neck communicates with the inside of the patient's trachea through a surgical opening in the trachea. Preferably, the inner diameter of the section of the splice piece (30) is between 0.2 and 5 cm, more preferably between 0.5 and 3 cm, even more preferably between 0.8 and 1.4 cm. Preferably, the area size of the section of the splice piece (30) is between 0.03 and 20 cm ² , more preferably between 0.2 and 7 cm ² , even more preferably between 0.5 and 1.5 cm ² . Preferably the coupling piece (30) is joined at its distal end to the proximal end of the tube (20). Note that the dimensions of the connecting piece (30) may vary depending on the dimensions of the tube (20) and/or the dimensions of the cannula or stoma, as well as the shape can be adapted to better fit the cannula or stoma of the patient and/or with the tube (20), as well as to improve their comfort. Note also that Figs. 1, 3 and 4 are merely illustrative, and do not represent the splicing piece (30) or other parts of the system (100) on a real scale, and the dimensions and shape of the splicing piece (30) may be different from what is represented. For example, the splice piece (30) in Figs. 1, 3 and 4 presents an elbow or curvature to allow the system to rest in a vertical position when not used for speaking, however, in other embodiments the splicing piece (30) may not comprise an elbow or curvature, and may be straight, or may be more or less curved than represented in Figs. 1, 3 and 4. Preferably the coupling piece (30) can be separated from the rest of the system (100), more preferably it can be separated from the tube (20). Preferably, the splice piece comprises a rigid material, such as, but not limited to, plastic materials, PVC, polypropylene, polyethylene, acrylic, metal elements or alloys.

The quantities mentioned may vary with a margin of 30%, that is, each diameter may measure 30% more or 30% less than indicated above. Preferably, this margin is ±20%, more preferably it is ±10%, even more preferably it is ±5%.

Advantageously, the presence of a splice piece (30) independent of the system (100) allows its disassembly and thus allows easy access for cleaning. Furthermore, the rigidity and shape of the connecting piece may be ideal for securing the system (100) to the patient's stoma or cannula, or for allowing the speech system (100) to rest in a vertical position when it is not being actively used to talk.

In another preferred embodiment, the tube (20) of the phonation system (100) is flexible, as can be seen in Fig. 1. Preferably, the tube (20) comprises a flexible material, such as, but not limited to. , plastic materials, rubber, rubber, silicone rubber, flexible polyurethane, flexible PVC, flexible polyethylene or Teflon. Note that the flexibility of the tube (20) can also be achieved through the shape of the walls of said tube (20), for example a tube can be made flexible from a rigid material if the walls have a wavy, sinuous, textured shape. , ridged, serpentine and/or a thin thickness.

Advantageously, the tube being flexible allows the distal end (102) of the system (100) to be moved closer and further away from the patient's mouth with ease.

In another more preferred embodiment of the invention, as can be seen in Figs. 2, 3 and 4, the nozzle (10) of the system (100) is connected by a recess (3) at its proximal end (12) to the distal end of the tube (20), and the coupling piece (30) is connected for a discount (3) at its distal end (32) to the proximal end of the tube (20). The presence of these recesses (3) allows both pieces to be easily attached and detached from the tube (20) of the system (100), exerting only slight pressure to fit them, this pressure allowing the elements to remain fixed.

Advantageously, the presence of these recesses (3) allows easy coupling and uncoupling of the elements of the phonation system (100), as well as guaranteeing adequate pressure so that they remain together when they are connected.

In one embodiment of the invention, the side hole (2) of the phonation system (100) is included in the mouthpiece (10).

Advantageously, this allows said hole (2) to be covered with the same hand with which the distal end (102) of the speaking system is directed to the mouth, thus making its use more comfortable as it can perform both functions at the same time with the hand. same hand, the one to direct and the one to cover and uncover the side hole (2).

In another embodiment of the invention, the phonation system (100) comprises a check valve (6) located on the surface of the lateral hole (2), so that it is not necessary to plug said lateral hole (2) with the fingers to prevent the exhaled air from leaving through it, since the check valve blocks the passage of air out of the system (100), that is, when exhaling, and opens when inhaling, allowing the circulation of air into the system (100). Note that when placing the check valve (6) on the surface of the side hole (2), this hole (2) is covered by said valve (6). The size of the check valve (6) may be larger than the size of the orifice (2), in particular the size of the check valve (6) is adequate to allow adequate inhalation. In a preferred embodiment, a "check valve" is understood as a device used in pipe and conduit systems to allow the unidirectional flow of fluids or gases and prevent the return or retreat of flow in the opposite direction. In the context of the invention, the check or return valve allows the passage of air from outside the phonation system to the inside, but prevents the passage of air from inside the system to the outside.

Advantageously, this valve allows you to perform phonation with the system (100) of the invention and inhale without having to manually block the side hole (2), by blocking and unlocking the valve the passage of air mechanically. In a more preferred embodiment of the invention, the phonation system (100) comprises a discharge valve (7), which allows air to pass out of the system (100) when the patient's exhalation exceeds a certain pressure threshold. . Preferably this pressure threshold is greater than the exhalation pressure necessary to perform phonation. More preferably this threshold is related to the pressure of normal breathing. Preferably, said discharge valve (7) blocks the passage of air out of the system (100) when the patient's exhalation does not exceed a certain pressure threshold related to normal breathing, but is instead a lighter exhalation intended to direct air to the mouth to perform phonation. In this way, with the discharge valve, the patient can breathe without having to manually block or unlock the side hole (2), by unlocking the discharge valve (7) mechanically, and can also perform phonation when exhaling with less intensity to direct the air towards your mouth, blocking the discharge valve (7) mechanically and unattended. In a preferred embodiment, “relief valve” is understood as a pressure relief valve. In the context of the invention, said valve opens when the air pressure inside the speech system reaches a level higher than that required for speaking.

Advantageously, the discharge valve (7), joined to the check valve, allows the patient to perform phonation and breathe in an unattended manner, without having to block and unlock the lateral orifice (2) manually, with the convenience That this entails.

In an even more preferred embodiment of the invention, the check valves (6) and discharge valves (7) are included in the connection piece (30).

Advantageously, since they are located in the connecting piece (30), which is the piece closest to the patient's stoma or cannula, the valves will not have to move continuously when moving the distal end of the system (100) towards the mouth or by letting it rest vertically, which reduces the chances of these valves being damaged and also makes it more comfortable and lighter to move the rest of the system (100) during normal use.

In another preferred embodiment of the invention, the phonation system (100) further comprises a housing for a filter element (5). Preferably, the phonation system (100) comprises said housing for the filter element (5) in the connection piece (30). In other embodiments of the invention, the phonation system (100) also comprises a filter element (5). Advantageously, the presence of a filter element (5) in the phonation system allows the filtering of the air inhaled and exhaled by the patient, thus avoiding contaminating the lungs and filtering particles and/or pathogens.

In another preferred embodiment of the invention, the phonation system (100) comprises an external air source, preferably a compressor, a compressed air cylinder, a manual pear, a bagpipe or an accordion. Preferably the phonation system (100) is further configured to be able to connect at its proximal end (101) with said external air source.

Advantageously, the presence of an external air source allows the patient to breathe directly through the stoma or cannula, and use the external air source to perform phonation, being able to do both activities simultaneously and more comfortably.

In another preferred embodiment of the invention, the system (100) comprises a microphone and/or an amplifier. Both microphone and amplifier can have wired connections, or, alternatively, operate wirelessly. Preferably, the system (100) comprises a microphone and an amplifier both connected via cable or wirelessly. Preferably the system (100) further comprises electronic circuits or a processing unit configured to electronically process the signal received at the microphone. Even more preferably, these electronic circuits or processing unit are included in the amplifier.

Advantageously, this allows the volume of the patient's voice to be raised. In addition, with the electronic circuit or the processing unit, the voice can be treated to improve its clarity and make it better understood.

In another preferred embodiment of the invention, the system (100) comprises a flexible hoop, tape, belt, or rope that surrounds the back of the head above the ears to hold the mouthpiece (10) in front of the patient's mouth. .

Advantageously, this allows the patient not to have to hold the speech system (100) with his hand and to be able to have both hands free when using the speech system.

In another embodiment, the phonation system (100) comprises means for attaching to the patient's head, neck, ears or clothing, preferably by means of a rubber band, a tape, a ring, a hook or a clip. For example, it may comprise a clip for attaching the system (100) to the lapel or collar of the patient's clothing. In another embodiment, the system It comprises a hook-shaped piece or a rubber band, adapted to the shape of the ear to fix the system.

Advantageously, this adds a wide range of options for holding the system (100) so that the patient does not have to hold it by hand, and thus can have both hands free when using the speaking system.

In a preferred embodiment of the invention, the tube (20) of the phonation system (100) comprises an elongated and malleable element inside, preferably metallic, configured to change shape when a force is applied to it and retain its shape when left. to apply force on it.

Advantageously, this allows the patient to easily bring the phonation system (100) closer to his mouth and leave it fixed in that position without having to use any other means of fixation that may present discomfort, having both hands free while performing phonation, and allows the patient to patient to reposition the system away from his or her mouth when finished speaking.

While specific forms of the present invention have been selected for purposes of illustration, one skilled in the art will recognize that various variations can be made from the examples set forth herein without departing from the scope of the present invention.

The industrial application of the invention is evidently derived from its explanation and its preferred embodiment.

It should be noted that, as used herein, the singular forms "a", "an" and "the", include plural references unless the context clearly indicates otherwise. Furthermore, unless otherwise indicated, the term "at least" preceding a series of elements should be understood to refer to each element of the series. Those skilled in the art will recognize, or be able to determine using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. It is understood that said equivalents are also covered by the present invention.

It is noted that the term "about", as used herein, refers to +/- 30%, preferably +/- 20%, preferably +/- 15%, more preferably +/- 10%, of the indicated value . As used herein, the term "and/or" set among multiple listed items is understood to encompass both individual and combined options. For example, when two elements are joined by "and/or", a first option refers to the applicability of the first element without the second. A second option concerns the applicability of the second element without the first. A third option concerns the applicability of the first and second elements together. Any of these options are understood to fall within the meaning and therefore satisfy the requirement of the term "and/or" as used herein. It is also understood that the simultaneous applicability of more than one of the options falls within the meaning and therefore satisfies the requirement of the term "and/or".

Throughout this specification and the claims that follow, unless the context otherwise requires, the word "comprehend", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a number established integer or step or group of integers or steps, but not the exclusion of any other integer or step or group of integers or steps. When used herein, the term "comprising" may be substituted by the term "containing" or "including" or, sometimes, when used herein, by the term "having." Any of the terms mentioned above (comprising, containing, including, having), whenever used herein in the context of an aspect or embodiment of the present invention, may be substituted by the term "consisting of", although it is less preferred .

When used here "consisting of" excludes any element, step or ingredient not specified in the claim element. When used herein, “consisting essentially of” does not exclude materials or steps that do not materially affect the basic and novel features of the claim.

CLAUSES

1. Phonation system for laryngectomized patients characterized by being based on the vocalization of words while air is blown into the oral cavity using a suitable element or mouthpiece (Fig. 1).

2. Phonation system according to clause 1 characterized in that the mouthpiece (Fig. 2) is connected to the stoma by a flexible tube and a connector (Fig. 3 and 4). Phonation system according to clause 1 characterized in that the mouthpiece (Fig.2) has a hole at its end of between 0.8 and 7 mm2 and may have another larger hole on one side to facilitate breathing. Phonation system according to the previous clauses characterized in that the connecting piece (Fig. 4) may comprise a check valve (7), a discharge valve (8) and a housing for a filter element (6). Speech system according to clause 1 characterized in that the air used in speech can come from an external source, such as a compressor or a compressed air cylinder. Phonation system according to the previous clauses characterized in that a microphone can be placed in the mouthpiece, connected by a cable, or wirelessly, to a portable battery-powered amplifier, in order to increase the volume of the phonation, with the possibility of electronic treatment the signal to improve understanding of phonation. Phonation system according to the previous clauses characterized in that the mouthpiece can be held in front of the user's mouth by a flexible ring that surrounds the back of the head above the ears in such a way that the user does not need his hand to hold the mouthpiece.

Claims

1. Phonation system (100) for laryngectomized patients comprising a proximal end (101) which comprises an inlet hole (33), a distal end (102) which comprises an outlet hole (1), and a tube (20), and which is configured to connect at its proximal end (101) with a cannula or stoma of the patient, where in addition the system (100) is configured to direct the exhaled air from the cannula or stoma towards the exit orifice ( 1) of the distal end (102) through said tube (20), characterized in that the system (100) also comprises a lateral hole (2) between the proximal end (101) and the distal end (102).

2. Phonation system (100) according to claim 1, comprising a mouthpiece (10) at its distal end (102), where said mouthpiece (10) comprises the exit hole (1) at its distal end (12), and where the diameter of the outlet hole (1) is between 2.7 and 14 times smaller than the inner diameter of the tube section (20).

3. Phonation system (100) according to claim 1 or 2, comprising a connector (30) at its proximal end (101), where said connector (30) is configured to connect to the cannula or stoma of the patient through its proximal end (4).

4. Phonation system (100) according to any of claims 1 to 3, wherein the tube (20) is flexible.

5. Phonation system (100) according to claim 3 or 4, wherein the mouthpiece (10) is connected by a recess (3) at its proximal end (12) to the distal end of the tube (20), and the coupling piece (30) is connected by a recess (3) at its distal end (32) to the proximal end of the tube (20).

6. Phonation system (100) according to any of claims 1 to 5, wherein the side hole (2) is included in the mouthpiece (10).

7. Phonation system (100) according to any of claims 1 to 5, wherein the system (100) further comprises a check valve (6) located on the surface of the side hole (2).

8. Phonation system (100) according to any of claims 1 to 5 and 7, wherein the system (100) further comprises a discharge valve (7).

9. Speech system (100) according to claim 8, wherein the check valve (6) and the discharge valve (7) are included in the connection piece (30).

10. Phonation system (100) according to any of claims 1 to 9, wherein the system of the invention (100) further comprises a housing for a filter element (5).

11. Speech system (100) according to any of claims 1 to 10, comprising an external air source, preferably a compressor or a compressed air cylinder, wherein the speech system (100) is further configured to be able to connect said external air source at its proximal end (101).

12. Phonation system (100) according to any of claims 1 to 11, comprising a microphone and an amplifier, both connected by a cable or wirelessly, preferably the system (100) further comprises a processing unit configured to electronically process the signal received in the microphone.

13. Phonation system (100) according to any of claims 1 to 12 comprising a flexible ring that surrounds the back of the head above the ears to hold the mouthpiece (10) in front of the patient's mouth.

14. Phonation system (100) according to any of claims 1 to 13 comprising means for fixing to the head, neck, ears, clothing, or to the patient's own cannula, preferably by means of a rubber, a tape, a ring, a hook or clamp.

15. Phonation system (100) according to any of claims 5 to 14, wherein the tube (20) further comprises an elongated and malleable element, preferably metallic, configured to change shape when a force is applied to it and to retain its shape. by stopping applying force on it.