Device to support verbal communication in tracheotomized, intubated, or laryngectomized patients

Abstract

The invention relates to a device for supporting verbal communication in tracheotomized, intubated, or laryngectomized patients. The device comprises the following elements: Means for generating an airflow; and a nozzle applicator connected via a supply tube to the means for generating the airflow, wherein the nozzle applicator has at least one air outlet nozzle designed such that, when used as intended, the airflow can be introduced through the open mouth into a vocal tract of the patient and the airflow exiting the air outlet nozzle produces white noise, characterized in that the supply tube is a nasal cannula with caudally oriented nasal nozzles and the nozzle applicator is connected to at least one of the nasal nozzles.

Description

[0001] The invention relates to a device for supporting verbal communication of tracheotomized, intubated or laryngectomized patients. Technological background

[0002] Mechanical ventilation is the artificial ventilation of the lungs. It serves to support or replace insufficient or absent spontaneous breathing. Its life-sustaining function is a central component of anesthesiology, emergency medicine, and intensive care medicine.

[0003] In invasive ventilation via natural body orifices through intubation, a tube is inserted through the mouth or nose into the trachea. Intubation is always necessary when the patient can no longer breathe independently, for example, during surgery, resuscitation, or when lung damage causes the blood oxygen saturation to drop below a critical level. The tube keeps the airway open, which would otherwise be closed due to insufficient muscle tone or absent reflexes.

[0004] Another option for invasive ventilation is a tracheotomy (tracheal incision). During this surgical procedure, an access point to the trachea is created through the soft tissues of the neck. Indications for a tracheotomy can include, for example, the need for long-term ventilation after accidents or disease-related lung damage.

[0005] In Germany alone, approximately 26,000 intensive care beds were statistically registered in 2023 out of a total of 480,000 hospital beds. Each year, around 385,000 patients with lung and respiratory diseases are treated as inpatients, of whom approximately 60% require mechanical ventilation for more than 24 hours.

[0006] For a conscious, alert patient, tracheotomized or intubated ventilation presents an unfamiliar situation, often accompanied by anxiety and stress. Ventilation therapy is a consequence of an acute event, planned surgery, or an acute lung disease. The experiences during this time can be traumatic for the patient. Feelings of helplessness frequently accompany this situation. The numerous machines and noises, physical frailty, and the complex medical situation constitute an exceptional circumstance. Furthermore, the ability to communicate is severely limited by ventilation, as speaking is not possible. In a survey of students and older adults, both groups cited interaction with family and friends, as well as maintaining personal autonomy, as the most important activities of daily life during illness.

[0007] There are many reasons for communication: • Call for help, attract attention • Provide or receive medically relevant information (e.g., pain, further procedure) • Express emotional needs • Maintain control • Give instructions or ask for help (e.g., moisten lips, suction) • Ask questions • Expressing personality, social interaction • Control the environment (e.g., music, television)

[0008] To prevent isolation and other consequences, alternatives that enable communication must be sought as early as possible. Known strategies for enabling direct communication during ventilation include: • The use of a speaking cannula on the endotracheal tube • Lip reading • The use of a writing tablet • The use of gestures and signs • Communication boards (with predefined letters, words, symbols or photos) • Electronic communication devices

[0009] State-of-the-art technology also includes so-called speech aids, which, based on the principle of generating an external glottal signal (with a fundamental frequency), couple a "chattering noise" from the outside via the soft parts of the throat. While the patient is able to speak, it is heavily overlaid by the "chattering" fundamental tone (perceived as a "robot voice").

[0010] Due to the exceptional circumstances, these communication strategies are often inadequate and of limited use to the patient. The inability to communicate is a very frustrating experience for the patient; they cannot describe their symptoms or communicate their feelings, such as pain. They are often misunderstood.

[0011] Verbal communication with patients who have had their larynx removed is also difficult. The larynx is located between the pharynx and the beginning of the trachea. It is essential for breathing and, through swallowing, prevents food from entering the trachea from the throat. The vocal cords (vocal folds) in the larynx primarily serve to produce a fundamental-tone sound, the source of voice production. For medical reasons or due to an accident, it may become necessary to remove the larynx, for example, in cases of laryngeal cancer. During the operation, the digestive tract is completely separated from the airway to prevent food or liquids from entering the lungs during swallowing. A stoma, an opening created in the neck, allows access to the trachea. Often, an adhesive strip with an air filter is placed over the stoma to retain moisture in the airways and lungs.This prevents the trachea from drying out and bacteria from multiplying in it.

[0012] After the operation, natural speech is no longer possible. Special training allows for the use of so-called pseudo-whispering. In this technique, the mouth movements mimic those before the operation, but without intonation. This pseudo-whispering is very quiet, like a whisper, and only intelligible in very quiet environments. Conversation partners must lip-read the words precisely. Therefore, pseudo-whispering is hardly sufficient for everyday communication.

[0013] The most common method for restoring the voice is the use of a voice valve. During the operation, a small connection (shunt) is created between your trachea and esophagus, and a voice valve (or shunt valve) is inserted into this connection. This is a one-way valve made of silicone rubber. This valve allows air to flow from the trachea into the esophagus. At the same time, the valve prevents food from the esophagus from entering the trachea.

[0014] When the stoma is closed with a finger during exhalation, air from the trachea is forced into the esophagus, causing the mucosal folds to vibrate. This creates sounds that are shaped into speech sounds in the mouth and throat. However, this new voice is somewhat deeper in men and significantly deeper in women than their previous voice. Furthermore, using the voice replacement requires practice. Another disadvantage is that the voice prosthesis needs to be replaced regularly because it can become leaky over time, and a check-up at the clinic is necessary.

[0015] Electronic speech aids are also used. An electronic speech aid is a device with a vibrating membrane that is pressed against the soft tissue of the throat or cheek. The device transmits sound vibrations to the throat. This produces sounds that are shaped into speech sounds by normal lip and tongue movements. A disadvantage is that one hand is always occupied holding the device. Furthermore, this type of voice replacement sounds "robotic" due to the dominance of the fundamental frequency and the direct radiation from the device.

[0016] Devices to support verbal communication can be found, for example, in JP 2007 - 20 757 A, CN 1 09 350 305 A, WO 2019 / 031 150 A1, DE 101 05 383 A1 and WO 2022 / 094 662 A1.

[0017] The invention is therefore based on the objective of enabling direct and simple verbal communication between the tracheotomized, intubated or laryngectomized patient and medical personnel or relatives. Summary of the invention

[0018] The device according to the invention for supporting verbal communication of tracheotomized, intubated or laryngectomized patients according to claim 1 comprises the following elements: Means for generating an airflow; and a nozzle applicator connected to the means for generating the airflow via a supply tube, wherein the nozzle applicator has at least one air outlet nozzle designed such that, when used as intended, the airflow can be introduced into the patient's vocal tract via the open mouth and the airflow exiting the air outlet nozzle produces white noise.

[0019] The supply tube is a nasal cannula with caudally oriented nasal prongs, and the nozzle applicator is connected to at least one of the nasal prongs.

[0020] Preferred embodiments of the invention can be found in the following description and the dependent claims. Brief description of the characters

[0021] The invention is explained in more detail below with reference to exemplary embodiments and the accompanying drawings. The figures show: Fig. Figure 1 illustrates, in a highly schematic way, the basic structure of a device to support verbal communication of tracheotomized, intubated or laryngectomized patients according to a variant of the invention. Fig. 2A and Fig. Figure 2B shows a conventional "nasal goggles" and a detailed view of the nozzles of the nasal goggles. Fig. Figure 3 shows a nozzle adapter according to the invention, which is connected to the nozzle of the nasal cannula, according to a first embodiment. Fig. Figure 4 shows a nozzle adapter according to the invention, which is connected to the nozzle of the nasal cannula, according to a second embodiment. Fig. Figure 5 shows a nozzle adapter according to the invention, which is connected to the nozzle of the nasal cannula, according to a third embodiment. Fig. Figure 6 shows a nozzle adapter according to the invention, which is connected to the nozzle of the nasal cannula, according to a fourth embodiment. Fig. Figure 7 schematically illustrates the position of the nozzle adapter according to the invention in a Fig. 3 similar embodiment and with a nasal cannula worn. Detailed description of the invention

[0022] The functions and possible variations of the invention are explained in more detail below using examples. However, the invention is not limited to these specific embodiments. General aspects of the invention

[0023] The device according to the invention for supporting verbal communication of tracheotomized, intubated or laryngectomized patients comprises the following elements: Means for generating an airflow; and a nozzle applicator connected via a supply tube to the means for generating the airflow, wherein the nozzle applicator has (at least) an air outlet nozzle designed such that, when used as intended, the airflow can be introduced into the patient's vocal tract via the open mouth and the airflow exiting the air outlet nozzle produces white noise.

[0024] With the aid of the device according to the invention, a tracheotomized, intubated or laryngectomized patient can whisper and verbal communication is made possible.

[0025] Whispering is a form of voiceless speech in which the sounds are not produced by the vibrations in the larynx caused by the airflow from the lungs—the sound of the voice. Unlike intonation, whispering is a noise, not a tone. When whispering, the vocal cords are in a paramedian position. In this position, the incoming or outgoing air from the lungs creates a fundamental-wave-free noise spectrum, which, through deformation of the internal structures of the mouth and throat, results in the production of a whisper. Despite the absence of characteristic spectral ranges of the human voice, automatic speech recognition of whispered speech is possible with current technology. A listener can also understand whispered words.

[0026] In the case of tracheotomized or intubated ventilation, or after surgical removal of the larynx, the airflow generated by inhalation and exhalation is absent at the vocal cords, and whispering is impossible. This is where the invention comes in. It has been found that whispering is also possible with an airflow introduced externally into the patient's vocal tract. The vocal tract is also referred to as the vocal tract. It comprises the air-filled spaces above the larynx, which are crucial for sound production. The vocal tract can be divided into three spaces: the pharynx, the oral cavity, and the nasal cavity. Tracheotomized or intubated patients can, for the first time, express themselves verbally in a manner that is familiar to them, with the aid of the introduced airflow. This is of considerable importance, particularly for the care and recovery of responsive intensive care patients.The device also represents an advantageous alternative to a voice valve or electronic speech aid for patients without a larynx.

[0027] The device includes means for generating an airflow. The generated airflow passes wholly or partially through the air outlet nozzle of the nozzle applicator, which is connected to the airflow generation means via a supply tube. The air outlet nozzle is designed so that, when used as intended, the airflow is directed into the patient's vocal tract through the open mouth. The airflow exiting the air outlet nozzle generates white noise. White noise is noise with a constant power spectral density within a specific frequency range. White noise is perceived as a sound with a strong emphasis on high frequencies. This significantly enhances human perception or machine-based enhancement of whispering sounds.

[0028] Patients who are unable to breathe through the mouth / nasal cavity (neither inhalation nor exhalation) are supplied with a minimal airflow for sound production via the device according to the invention. The airflow is generated with the spectrum of "white noise" and is non-invasively introduced into the oral cavity, a natural body opening, through at least one nozzle via a slightly opened mouth. This "white noise" airflow stimulates the vocal tract retrogradely, acting as a natural acoustic filter formed by the anatomical hard and soft structures of the mouth, nose, and pharynx. It is thus used for whisper articulation, primarily of vowels, as components of speech sounds (comparable to a voiceless, modulated spectrum without a fundamental frequency, which is normally generated in the glottis, the "glottis generator").This simple method of generating a "retrogradely stimulated whisper" is fundamentally suitable for the patient's intended verbal communication. By employing further techniques, the quality of the initial "whisper voice" can be improved, ultimately leading to the reconstruction of the patient's voice with its individual timbre.

[0029] The supply tube is a nasal cannula with caudally oriented nasal tips, and the nozzle applicator is connected to at least one of the nasal tips. Nasal cannulas are established medical devices or accessories for administering oxygen. They comprise a tube that is connected, for example, to a medical gas cylinder (compressed air or oxygen), preferably to the medical compressed air supply as part of the infrastructure. With conventional nasal cannulas, oxygen is delivered to the patient's nostrils via an adapter with two cranially oriented nasal tips when used as intended. For the device according to the invention, the adapter only needs to be modified so that the nasal tips are caudally oriented. This can usually be implemented very easily with conventional nasal cannulas if the adapter and tube are still flexibly connected to each other.This allows the use of a medical device that is usually already available during inpatient treatment, resulting in a significant cost reduction. The nozzle adapter is connected to either one or both nasal prongs. If it is only connected to one nasal prong, the second is fitted with a sealing plug.

[0030] A preferred embodiment of the device further provides that the nozzle applicator has a base body with an air channel to which the air outlet nozzle is attached and which is connected to the supply tube. In other words, the nozzle applicator has a channel suitable for the passage of the supplied airflow. The air outlet nozzle is located on this channel, from which an airflow used to assist whispering emerges. The channel has an inlet end that is connected to the supply tube. In this embodiment as well, the supply tube can be designed in the form of a nasal cannula with caudally oriented nasal tips. At the other end of the channel, the portion of the airflow that was not introduced into the patient's vocal tract through the air outlet nozzle exits.

[0031] Preferably, a drainage tube is connected to the downstream end of the air channel. If sufficiently long, the drainage tube can be held in the patient's hand. When the patient covers or clamps the drainage tube, the air pressure inside the device increases. This also increases the volume of air exiting the nozzle of the nozzle applicator, or it causes the air to be introduced through the nozzle only to a significant extent. The patient can therefore control the function of the device very easily.

[0032] According to a further embodiment, the nozzle applicator is designed to be separable from the device. In this embodiment, the nozzle applicator is provided as a separate component which, when assembled with other components, forms the device according to the invention. The nozzle adapter can therefore be supplied as a medical consumable.

[0033] In a further embodiment, which can also be combined with the previously described variants of the device, the means for generating the airflow is part of a medical gas supply system. Medical devices connected to the gas supply system, such as flowmeters or pressure reducers, are usually already present or in use on the patient and are dimensioned so that the set airflow is suitable for the purposes of the device. Then, only the nozzle applicator needs to be connected to the compressed air connection.

[0034] In another variation of the device, the airflow is generated by a portable blower. The technical basis of such a device is, for example, a small box with a mini-blower, consisting of an airflow noise generator (e.g., a mini radial fan with a battery pack for a shirt pocket or chest pouch, controlled via an app using Bluetooth communication), and a nozzle applicator that feeds the noise signal into the patient's open mouth via a supply tube. The supply tube can be attached to a headset or eyeglasses, for example.

[0035] According to a further preferred embodiment, which can also be combined arbitrarily with the previously described variants of the device, it is provided that the device includes a signal processing unit which contains a module for detection, a module for enhancement (in the simplest case of amplification or noise suppression) and a module for acoustic reproduction of a whisper signal generated by the patient.

[0036] The module suitable for capturing the whisper signal produced by the patient could, for example, be a miniature microphone. The microphone can be attached to the periphery of the stationary patient, for instance, to the patient grab bar of the hospital bed. The microphone is specifically designed for wireless communication and can, for example, have a Bluetooth interface. Alternatively, or in the case of mobile patients, the microphone can be attached to glasses or a headset.

[0037] This is based on the understanding that the retrograde whispered speech signal is fundamentally suitable for further use in the largely natural reconstruction of the patient's "real" speech with its natural, individual timbre.

[0038] An extended embodiment of the signal processing unit includes a module for enhancing, in this case reconstructing, the whisper signal.

[0039] The module for the unit that enhances the captured whisper signal can be a conventional data processing device configured to run a program for analyzing the whisper signals. For example, the data processing device could be a smartphone with a whisper signal enhancement program (an app) installed. This program is speech reconstruction software. It filters the whisper signal, which is overlaid with white noise, and generates / regenerates the speech consonants that the patient cannot articulate, or can only articulate to a limited extent, due to the lack of primary airflow from the lungs. The signal processing unit allows the patient's voice or speech to be reconstructed in a largely natural-sounding manner. Speech reconstruction software comprises a speech recognition subunit and a speech reconstruction subunit based on the captured speech signals.The latter subunit could, for example, be an AI-based speech signal decoder that allows vocabulary-triggered addition of voice fundamental wave and speech consonants and sounds.

[0040] The module for enhancing the captured whisper signal can also be designed to dynamically control noise generation. For example, activation of the device for generating the airflow to be introduced into the patient's vocal tract can be triggered by the detection of the onset of lip movement.

[0041] The module for acoustically reproducing a whisper signal generated by the patient can be a loudspeaker, for example, a miniature speaker attached to the patient's glasses or headset and wirelessly connected to the module for processing the captured whisper signal. Alternatively, the speaker of the smartphone on which the module for processing the captured whisper signal is installed can be used. It is also conceivable that the reconstructed speech signal provided at the data output of the module for processing the captured whisper signal can be sent to any receiver or made available for other applications. For example, the reconstructed speech signal can be used for telephone or video conferencing applications. Another application is the control of network-enabled devices, for example, to adjust the volume of a television.

[0042] Furthermore, the reconstructed speech signal can be transmitted, for example, to a nursing staff member's smartphone or the patient's tablet in a monitoring room of the intensive care unit. The device significantly facilitates verbal communication with medical staff. In particular, the device can be used to support and verify patient-triggered alarms or for enhanced acoustic patient monitoring. Specific embodiments

[0043] Fig. Figure 1 illustrates, in a highly schematic form, the basic structure of a device 100 for supporting verbal communication in tracheotomized, intubated, or laryngectomized patients according to a variant of the invention. The device 100 comprises means for generating an airflow 10 and a nozzle applicator 30, which is connected to the means for generating the airflow 10 via a supply tube 20. The nozzle applicator 30 has an air outlet nozzle 32, which is designed such that, when used as intended, the airflow can be introduced into the vocal tract of the patient 40 via the open mouth 42, and the airflow exiting the air outlet nozzle 32 generates white noise.

[0044] The means for generating the airflow 10 can be part of a medical gas supply system, for example, flowmeters or pressure reducers connected to medical compressed air. The generated airflow is guided via the supply hose 20 to the nozzle applicator 30 and exits there from the air outlet nozzle 32. The geometry of the air outlet nozzle 32 and the means for generating the airflow 10 are coordinated to produce a "white noise" airflow. The airflow entering the mouth 42 of the patient 40 enables the patient 40 to whisper via the vocal tract in an almost natural manner.

[0045] The whisper signal generated by the patient can be further processed by a signal processing unit 50. The signal processing unit 50 comprises a module for capturing 52, a module for enhancing 54, and a module for acoustically reproducing 56 the whisper signal generated by the patient 40. The signal processing unit 50 can be used to reconstruct or amplify the patient's natural speech. Modules 52, 54, and 56 of the signal processing unit 50 can be implemented in whole or in part in a smartphone.

[0046] Fig. 2A and Fig. Figure 2B shows a conventional nasal cannula 200 and a detailed view of the nozzle 210 of the nasal cannula 200. Nasal cannulas 200 are established medical devices and are routinely used for non-invasive support of patient ventilation. The nasal cannula 200 is connected to an air generator (not shown) via an adapter 220. The airflow is directed through the tubing to the nozzle 210 and exits through two nasal ports 212.

[0047] For the purposes of the invention, the nasal cannula 200 can assume the function of the supply tube 20. The nasal cannula 200 is connected to a medical compressed air source in the conventional manner. The nozzle 210 is then connected to the nozzle applicator 30. To generate the airflow, a small dose of medical compressed air, such as that available via a standardized connection at every patient bed in intensive care units, can be introduced into the nasal cannula 200. Such connections typically also include pressure reducers or flow meters, which can be used to adjust the airflow. The nasal cannula 200 is applied to the patient 40 in the usual way, i.e., positioned under the nose, over the ears, and under the chin.However, the nasal prosthesis 200 is applied in such a way that the two nasal openings 212 of the nasal prosthesis 200 are not inserted into the nose, contrary to their intended purpose, but are rotated 180° away from the nose towards the mouth 42. Fig. Figure 7 schematically illustrates the position of the nozzle adapter according to the invention in a Fig. 3 based embodiment and with a nasal cannula 200 in place. The nozzle adapter 30 is connected airtight to a downwardly (caudally) directed nasal nozzle 212.

[0048] Fig. Figure 3 shows a first embodiment of the nozzle adapter 30, which is connected to the nozzle 210 of the nasal cannula 200. One of the nasal ports 212 is closed with a sealing plug 34. The actual nozzle adapter 30, which contains a proximally directed air outlet nozzle 32, is connected to the nasal port 212 on the right in the figure. A drainage tube 36 is attached distally to the base of the nozzle adapter 30. The drainage tube 36 is open at its distal end, so that the continuous airflow escapes from this end of the tube during pauses in speech. If necessary, the patient 40 can close the drainage tube 36 by pressing, holding, or using a tube clamp, and the air then escapes through the air outlet nozzle 32 and enters the patient's vocal tract. The connections of the sealing plug 34 and the nozzle adapter 30 are in the embodiment according to Fig. 7 is reversed. The air outlet nozzle 32 is aligned towards the patient's mouth opening.

[0049] Modulation of the noise spectrum carried by the airflow can now be achieved by deforming the vocal tract as a dynamic filter solely through voiceless articulatory movements of the patient's mouth and throat. An artificial whisper is thus generated. This retrogradely generated whisper can be effectively produced by the patient with minimal airflow emanating from the air outlet nozzle 32, using the simplest of means. Fig. Figure 4 shows a further variant of the nozzle adapter 30 according to the invention, which is connected to the nozzle 210 of a nasal cannula 200. The base body of the nozzle adapter 30 is arc-shaped and is attached to both nasal prongs 212. The air outlet nozzle 32 is arranged centrally.

[0050] Fig. Figure 5 shows a further variant of the nozzle adapter 30 according to the invention, which is connected to the nozzle 210 of a nasal cannula 200. The base body of the nozzle adapter 30 tapers in a T-shape and is connected to both nasal prongs 212. The air outlet nozzle 32 is located at the distal end of the nozzle adapter 30.

[0051] Also Fig. Figure 6 shows a further variant of the nozzle adapter 30 according to the invention, which is connected to the nozzle 212 of a nasal cannula 200. The base body of the nozzle adapter 30 is the same as in the embodiment according to Fig. 5 is connected to both nasal prongs 212. However, the distal end of the nozzle adapter 30 with the air outlet nozzle 32 is not positioned centrally, but rather slightly angled on one side. With this nozzle adapter 30, the airflow is introduced at the edge of the mouth. Reference symbol list 10 means of generating an airflow 20 supply hose 30 nozzle adapters 32 Air outlet nozzle 34 sealing plugs 36 Drainage hose 40 patients 42 Patient's mouth 50 Signal processing unit 52 Module for recording 52 the whisper signal generated by patient 40 54 Module for enhancing the whisper signal generated by patient 40 56 Module for acoustic playback 56 of the whisper signal generated by patient 40 100 Devices to support verbal communication for tracheotomized, intubated, or laryngectomized patients 200 nasal cannulas 210 Nose of nasal cannula 200 212 nosepieces 220 Adapter connection for nasal cannula 200

Claims

[1] Device (100) for supporting verbal communication of tracheotomized, intubated or laryngectomized patients, wherein the device (100) comprises the following elements: Means (10) for generating an airflow; and a nozzle applicator (30) which is connected via a supply tube (20) to the means (10) for generating the airflow (10), wherein the nozzle applicator (30) has at least one air outlet nozzle (32) which is designed such that, when used as intended, the airflow can be introduced into a vocal tract of the patient via the open mouth and the airflow exiting the air outlet nozzle (32) generates white noise, characterized by , that the supply tube (20) is a nasal cannula (200) with caudally oriented nasal nozzles (212) and the nozzle applicator (30) is connected to at least one of the nasal nozzles (212). [2] Device (100) according to claim 1, wherein the nozzle applicator (30) has a base body with an air channel to which the air outlet nozzle (32) is attached and which is connected to the supply hose (20). [3] Device according to claim 2, wherein a discharge hose (36) is connected to the downstream end of the air duct. [4] Device (100) according to one of the preceding claims, wherein the nozzle applicator (30) is designed to be separable from the device (100). [5] Device (100) according to one of the preceding claims, wherein the means (10) for generating the airflow is part of a medical gas supply system. [6] Device (100) according to one of the preceding claims, wherein the means (10) for generating the airflow is a portable blower. [7] Device (100) according to one of the preceding claims, wherein the device (100) comprises a signal processing unit (50) comprising a module for detecting (52), a module for enhancing (54) and a module for acoustic playback (56) of a whisper signal generated by the patient.

Images