System and method for artificial voice generation

Abstract

A respiratory driven voice generation system enables production of a high-quality artificial voice. The system includes an airflow chamber, wherein the airflow chamber comprises a first, second and a third opening with the airflow chamber defining an automatic air passage between the first, second and the third openings, and a voice chamber which comprises an air inlet and a voice outlet, where the air inlet of the voice chamber is in communication with the third opening of the airflow chamber, and whereby a generated voice exits the voice chamber via the voice outlet. The airflow chamber includes a first movable member that can be adjusted to match the respiration efforts of different users for ease of use and the voice chamber includes a second moveable member that can be customised to generate a range of male / female or non-binary voice profiles.

Description

SYSTEM AND METHOD FOR ARTIFICIAL VOICE GENERATIONRELATED APPLICATIONS

[0001] The present application claims convention priority from Australian provisional patent application AU 2023903513, filed 1 November 2023, and United States provisional patent application US 63 / 595,183, fded 1 November 2023. The content of AU’513 and US’ 183 is incorporated herein by reference in their respective entireties.TECHNICAL FIELD

[0002] The present invention generally relates to artificial voice generation. In further examples, the present invention relates to methods and systems for generating a voice.BACKGROUND

[0003] The larynx, also known as the voice box, is the organ used to generate the sound that humans use for speech. The larynx houses the vocal folds which are the source of a person’s voice. When a healthy person speaks, the sound (or “the voice”) produced by the vocal folds in the larynx enters the vocal tract where the voice is filtered (e.g., by controlling movement of the tongue and lips) to produce speech (Figure 1A). A person whose larynx has been surgically removed (through a laryngectomy) or bypassed (through a tracheostomy) is not paralyzed and may still be capable of controlling the vocal tract but lacks the vocal folds to generate a voice. These also may breathe through an opening in their neck called stoma (Figure IB). Such a person is therefore unable or inhibited in his ability to generate a voice without an artificial aid.

[0004] One example artificial aid is an electrolarynx, which is a handheld device that a laryngectomy patient presses against the skin of his or her neck or face to speak. The device functions by inducing vibrations into the vocal tract as an artificial voice source that the person can then shape into speech by controlling movement of the tongue and lips. The voice produced by an electrolarynx, however, tends to have a robotic tone, as well as being generally inconvenient for the person to be forced to manually operate the device while speaking.

[0005] During laryngectomy or tracheostomy, a permanent opening known as a stoma is produced in the neck or the chest of the patient for breathing through (a.k.a., the neck stoma). As a result, the patient’ s trachea is no longer in communication with the vocal tract so that air from the lungs exits through the stoma and cannot enter the vocal tract. A- 1 -RECTIFIED SHEET (RULE 91)tracheoesophageal voice prosthesis (TEP) is another type of voice prosthesis (artificial aid) conventionally employed by laryngectomy patients. The TEP is a plastic valve which is surgically inserted inside the throat between the trachea and the oesophagus. The TEP allows air from the lungs to re-enter the oesophagus and, from there, travel through the throat and vibrate tissues inside the throat, thus generating a voice (similarly to how sound is generated during belching). While the resulting speech is intelligible, the TEP is a primitive solution and suffers from several critical drawbacks. For example, the TEP is highly invasive, it causes infection and swallowing bio-hazards, and the voice generated is limited to a hoarse and whispery quality. These maintain a similar intonation range for men and women, essentially making women sound male. The existing solution also lack the ability of adapting or having adjustable parameters to suit different patient needs.

[0006] There is therefore a strong need for a novel system and / or method for generating voice for voice-loss people that eliminates or addresses some of the limitations of prior solutions.

[0007] The reference in this specification to any prior publication (or information derived from the prior publication), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that the prior publication (or information derived from the prior publication) or known matter forms part of the common general knowledge in the field of endeavor to which this specification relates.INCORPORATION BY REFERENCE

[0008] Each of the patents, publication, or non-patent literature which may be referred to in the application is considered incorporated by reference in its entirety as if each was incorporated by reference individually.SPECIAL TERMINOLOGY

[0009] The term “automatically” in the following documents is defined as using a system or a part of a system as handsfree or without needing a user to manually control or adjust the function of set part of the system or the entire system.

[0010] The term neck stoma in the following documents is used to indicate the trachea (airway) opening on the neck or the chest of the patient.SUMMARY OF THE INVENTION[Oil] This Summary is provided to introduce a selection of concepts in a simplified formthat are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0012] This invention proposes a respiratory driven voice generation system and method that is hygienic, non-invasive and non-surgical for people experiencing voice-loss including laryngectomy or tracheostomy patients. The invention describes a functional respiratory driven artificial voice source which is capable of generating an exceptionally high-quality voice. Further, this invention proposes a voice generation system which can be adjustable to different user needs including for example generating voices with a wide range of adjustable parameters including male, female or non-binary voices. Those skilled in the art will appreciate that not all embodiments of the present invention include all of the above advantages.

[0013] The devices and methods disclosed herein can comprise an artificial larynx and methods of using the artificial larynx to generate voice in people who are experiencing voiceloss following surgical removal or bypass of the larynx including laryngectomy or tracheostomy.

[0014] According to an example aspect, there is provided a voice generation system which is in communication with the neck stoma of a patient and receives inhaled and exhaled airflow from the stoma. The voice generation system can further include an open-end voice outlet that is in communication with the oral cavity of the user to generate voice. The user uses the voice generation system as an artificial speech aid or artificial larynx to generate speech.

[0015] According to an example aspect, there is provided a voice generation system which can, for example, provide a non-invasive and non-surgical method of generating voice.

[0016] Moreover, since the voice generation system as disclosed in this invention is provided by the natural exhale process similar to the healthy voice generation, the user becomes able to speak without the need for manual intervention.

[0017] According to an example aspect, there is provided a voice generation system that can, for example, provide an artificial larynx capable of automatic bidirectional breathing, allowing a subject to hands-free inhale and exhale without removing the device.

[0018] According to an example aspect, there is provided a voice generation system which can, in some examples, provide an artificial larynx suitable for hands-free use.

[0019] According to an example aspect, there is provided a voice generation system which can generate voice in a subject. In some examples the device, system or method as disclosedherein is driven by exhaled airflow to generate voice. In some examples the device, system or method as disclosed herein uses exhaled airflow to generate an exceptionally high-quality voice for a subject. Devices and methods as disclosed herein can, for example, provide an artificial larynx capable of generating voice with selective or adjustable parameters (e.g., pitch range, voice spectrum, choice of voice quality associated with a gender, etc.).

[0020] According to an example aspect, there is provided a voice generation system which is in contact with the patient neck stoma through medical grade barrier to maintain hygiene and stoma safety. The device, system or method as disclosed herein is non-surgical and non- invasive (wearable). In some examples the device, system or method as disclosed herein can be a hygienic solution which is in indirect contact with the patient neck stoma using a medical grade respiration barrier to maximise hygiene. In some examples the device, system or method as disclosed herein is in part or completely washable. In some examples the device, system or method as disclosed herein comprises an artificial larynx that is completely or partly disposable. According to an example aspect the voice generation system can comprise of disposable and replaceable parts, for example parts that that can be detached or disposed at any time to maximize hygiene. According to an example aspect the voice generation system is not in direct contact with the airway or the stoma, for example a device and protects against saliva and bacteria entry into the airway, etc.).

[0021] According to an example aspect, there is provided a respiratory driven voice generation system which can be customized to function for different users including having customizable voice generation parameters to generate male, female or non-binary voices. In some examples the voice generation system as disclosed herein can have customizable parameters such as adjustable airflow resistance to provide easy and comfortable use for people with different respiration powers including for example people with small, medium, or large lung capacities. In some examples the voice generation system as disclosed herein can have customizable parameters which can be adjustable to work for people with different respiration efforts and different lung sizes. In some examples the voice generation system as disclosed herein can have customizable parameters for the device to generate voice with a respiration effort that is close to tidal breathing and comfortable for the user. This enables the device to minimize user fatigue and be suitable for long term use.

[0022] According to an example aspect, there is provided a voice generation system comprising an airflow chamber (a.k.a., air chamber), wherein the airflow chamber can comprise a minimum of a first opening, second opening and third opening (air outlet), wherein the first opening of the airflow chamber is in communication with the neck stomavia a medical grade respiration barrier. The airflow chamber as disclosed herein includes a first movable member (movable air member) wherein the first movable member is configured to act as a multi-directional air valve to direct the air inside the airflow chamber between the first opening, second opening or the air outlet. The airflow chamber and the movable air member as disclosed herein can provide a minimum three different modes of: 1) automatic inhale, 2) automatic exhale (bidirectional breathing), whereby the user can naturally inhale and exhale without the need for removing the device from the stoma and 3) automatic voice generation. The airflow chamber may additionally provide more modes such as for example a bypass mode, where the user can disable the voice generation function of the device when they need to cough or breathe heavily without the need to remove the device from the stoma.

[0023] According to an example aspect the voice generation system airflow chamber and the movable air member can have adaptive, adjustable or pre-set of configurable setting including a selective pneumatic resistance, for the device to work for people with a wide range of respiration dynamics including for example low medium or high respiration efforts.

[0024] According to an example aspect the voice generation system comprises an airflow chamber which is configured to be in communication with, sealed against or include a medical grade respiration barrier, where the medical grade respiration barrier is in communication with the neck stoma of the user. According to an example aspect, the airflow chamber provides a hygienic and safe communication with the stoma and the airway via the medical grade respiration barrier to protect the airway from water leakage, bacteria or other contaminants. In some embodiments the medical grade respiration barrier may be a non- separable part of the airflow chamber. In some embodiments the medical grade respiration barrier may be an attachable or removable part of the airflow chamber. The medical grade respiration barrier may be separate and not part of the airflow chamber in some embodiments but attachable or detachable to the device.

[0025] According to an example aspect, the medical grade respiration barrier can be a Heat and Moisture Exchanger (HME) including for example an HME disc or HME cassette used by laryngectomy patients. According to another example aspect, the HME disk or HME cassette can be part of the voice generation system and be included in the airflow chamber or separate from the airflow chamber and attachable or detachable to it.

[0026] According to an example aspect, there is provided a voice generation system comprising an airflow chamber, wherein the airflow chamber can be attached to or include a medical grade respiration barrier, where the medical grade respiration barrier is coupled tothe stoma using a stoma attachment. In some embodiments the stoma attachment can be part of the device. In some embodiments the stoma attachment may be separate and not part of the device.

[0027] According to an example aspect, the stoma attachment can include for example an adhesive substrate, which can be attached to the skin around the neck stoma of a human subject including for example a laryngectomy baseplate. The stoma attachment substrate can in other examples penetrate partly or deeply inside a stoma, for example similar to laryngectomy, lary-button, or larytube, or tracheostomy tubes widely used by laryngectomy or tracheostomy users.

[0028] According to an example aspect the voice generation system comprises an airflow chamber which is configured to be in communication with, sealed against or include the medical grade respiration barrier. In some embodiments the airflow chamber coupled with its medical grade barrier can be easily detached from the rest of the voice generation system. This provides the device with ease of portability. In some embodiments the airflow chamber coupled with its medical grade barrier can be easily detached from the rest of the voice generation system where the airflow chamber coupled with its medical grade barrier can continue to stay on the stoma without the need to remove it from communication with the stoma. This provides the device with additional stoma safety.

[0029] According to an example aspect the voice generation system comprises a voice chamber which comprises an air inlet and a voice outlet wherein the voice chamber’ s air inlet is in communication with the airflow chamber’s air outlet and the voice chamber’s voice outlet is in communication with the oral cavity of the user, wherein the voice chamber contains a second movable member (movable voice member) that generates sound from the air which exits the airflow chamber’s air outlet, where the generated voice exists the voice chamber via the voice outlet to excite the oral cavity of the user.

[0030] According to an example aspect the voice generation system comprises a voice chamber which comprises a movable voice member which can generate a voice with an exceptionally high-quality close to sounding natural. In some embodiments the voice chamber and the movable voice member have customizable parameters that can be adjusted to generate a wide range of voices with exceptionally high quality for men. In some embodiments the voice chamber and the movable voice member parameters can be adjusted to generate a wide range of voices with exceptionally high quality for women. In some embodiments the voice chamber and the movable voice member parameters can be adjusted to generate a wide range of voices with exceptionally high quality for non-binary voices.

[0031] According to an example aspect the voice chamber and movable voice member can generate a flat or semi-flat frequency spectrum (with harmonic peaks amplitudes varying from + / -2dB to + / -3dB to + / -4dB to + / -5dB to + / -6dB spanning from the frequency range of 70Hz up to 200 Hz, 70Hz up to 300 Hz, or 70Hz up to up to any value between 300 Hz to 1500 Hz). In some embodiments the flat or semi-flat frequency spectrum of the proposed voice generation system enables the user to generate a highly intelligible speech. In some embodiments the flexibility and shape of the movable voice member can be adjusted for the fundamental frequency of the harmonic spectrum of the source to span from male (70-150 Hz) to non-binary (130-160 Hz) to female (160 - 240 Hz) and higher values for children.

[0032] According to an example aspect the voice chamber or movable voice member can provide adaptive, adjustable or pre-set parameters of voice generation including a selective, adjustable or pre-set fundamental frequency range to generate male, female or non-binary voices, or selective spectral features to improve the clarity of the voice for the user.

[0033] According to an example aspect the voice chamber or movable voice member can provided customizable, adaptive or pre-set parameters that are configured to match the respiration characteristics of different people. For example, in some embodiments the voice chamber or movable voice member parameters can be configured for the device to generate voice with a respiration effort that is close to tidal breathing and comfortable to use for the user by adjusting the pneumatic resistance of the device to match respiration effort of different people in speech. This enables the device to minimize user fatigue and be suitable for long term use.

[0034] According to an example aspect the voice generation system comprises devices and methods as disclosed herein can provide an artificial larynx capable of hands-free use (e.g. when worn as a headset around the ears, or worn around or behind the neck in a neckband) wherein the medical grade respiration barrier and the multidirectional air valve function of the air chamber (a.k.a., air flow chamber) enables the device to remain connected to the stoma without the need for manual interference.

[0035] According to an example aspect the voice generation system disclosed herein comprises an artificial larynx capable of generating voice in a subject and methods of using the same for generating speech in a subject. The devices as disclosed herein can provide a hygienic and safe method of communicating with the airway through the neck stoma, where the medical grade respiration barrier serves as an interface to protect the airway from dust, saliva, bacteria or other potential contaminants.

[0036] According to an example aspect the voice generation system discloses a miniature,removable and portable artificial larynx. The devices as disclosed herein can comprise an artificial larynx that can be detached from the neck stoma or stoma attachment when needed.

[0037] According to an example aspect the voice generation system disclosed herein comprises an Air chamber that is adjustable to seal over or fit people with different stoma shapes and structures wherein the device is fitted to the different shapes of stoma either:

[0038] a) through stoma attachments that attach to the skin or penetrate inside the stoma. These provide a standard aperture for the air chamber and its medical grade respiration barrier to connect to, or

[0039] b) through a compressible first opening of the air chamber that seals over the stoma of different users.

[0040] According to an example aspect the voice generation system provides the passage of exhaled airflow which naturally includes moisture may result in condensation of moisture inside the device. In some embodiments the device can comprise automated or manual condensation removal methods including for example a moisture sensor or a moisture trap (also called water trap) to remove capture or contain condensation water droplets inside. In some embodiments, the device can include hydrophobic coating of internal surfaces to prevent condensation droplets to shape and obscure the device. In some embodiments, the device can include thermal isolation to prevent condensation. In some embodiments the device can be made of selective, semi-permeable or breathable material that pass water vapor, condensation and built up moisture to the surrounding environment, thereby reduce or prevent condensation.

[0041] According to an example aspect the voice generation system can provide easy replacement of the first or second movable members.

[0042] According to an example aspect of the voice generation system the first or second movable member can be a flexible membrane (called air membrane and voice membrane respectively) with customizable parameters including for example material, flexibility, shape or thickness.

[0043] According to an example aspect the voice generation system can provide mechanisms to avoid the voice membrane jamming as the result of additional pressure build up inside the voice chamber.

[0044] Devices and methods disclosed herein describe a voice generation system with tuneable, pre-set or adaptive parameters that can adjust to the user needs including for example adaptive parameters for voice generation and respiration effort usability for a wide range of users. Any of these parameters including for example the wide range of pitch valuesfor men, women or children or the pneumatic resistance of the device which can be adjusted to user needs or to provide a level of comfort for different people. Any of these parameters can be provided in adaptive, adjustable or pre-set values and settings. These or pre-set values are called “quantized” values in this disclosure. For example, the pitch rage of the device can be pre-set (quantized) in four levels of male, female, non-binary or child or quantized to include more detailed pitch ranges. Similarly, in some embodiments the respiration efforts of the device can be quantized as low, mid or high. The voice generation system can have functional, clinically verified, tuneable or preset (quantized) parameters for the device to work comfortably for a wide range of users.

[0045] Other aspects, features, and advantages will become apparent from the following Detailed Description when taken in conjunction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of the various embodiments.BRIEF DESCRIPTION OF FIGURES

[0046] Figure 1 illustrates a healthy person (A) and an example person (B) who has lost their larynx due to the laryngectomy, and who breathes through a stoma (the stoma can be located on the neck or chest of the user and connects to their airway).

[0047] Figure 2A illustrates a first general embodiment of the voice generation system 100 disclosed herein, which comprises an airflow chamber 100AC and a voice chamber 100VC, where the airflow chamber 100 AC is in communication with a medical grade respiration barrier, voice generation system 100 further comprises an open-end voice outlet 100c which is in communication with the oral cavity.

[0048] Figure 2B illustrates a second general embodiment of voice generation system 100 disclosed herein, which comprises an airflow chamber 100AC and a voice chamber 100VC, where the airflow chamber 100 AC includes a medical grade respiration barrier 105 and is in communication with the Stoma or stoma attachment, voice generation system 100 also comprises an open-end voice outlet 100c which is in communication with the oral cavity.

[0049] Figure 2C illustrates a third general embodiment of voice generation system 100, which comprises an airflow chamber 100 AC and a voice chamber 100VC, where the voice generation system 100 further includes a medical grade respiration barrier 105 and a medical grade stoma attachment 130, where the stoma attachment 130 is in communication with the Stoma, voice generation system 100 further comprises an open-end voice outlet 100c which is in communication with the oral cavity.

[0050] Figure 3 illustrates exemplary stoma attachment methods which may or may not be part of the voice generation system 100, including: Figure 3A - stoma attachment using an adhesive substrate; and Figure 3B - stoma attachment using a penetrative substrate.

[0051] Figure 4 shows an example embodiment of the airflow chamber 100AC. Figure 4A shows an assembled airflow chamber 100AC comprising an airflow chamber housing 1000_AC, a first opening 100a (air inlet / outlet), a second opening 100b (air inlet / outlet) a third opening 100AC_c (the air outlet). Figure 4 A further demonstrates for example a fourth opening 100AC_d (air_window). Figure 4B shows a disassembled embodiment of airflow chamber housing 1000_AC.

[0052] Figure 5 illustrates an assembled exemplary embodiment of the airflow chamber 100 AC with a stoma attachment 200 and medical grade respiration barrier which may be part of the device 105 or independent of the device 205. Figure 5A shows an example airflow chamber 100AC in a disassembled view and Figure 5B shows the corresponding assembled view.

[0053] Figure 6 shows an assembled example of the airflow chamber 100AC with a medical grade respiration barrier 105 (shadowed), wherein the barrier 105 is embedded as an inseparable part of device in Figure 6A. Figure 6B shows an example of the airflow chamber 100AC where the airflow chamber 100AC can be opened to include a detachable and removable medical grade respiration barrier which may be part of the device 105 or independent of the device 205.

[0054] Figure 7 illustrates an example of the voice chamber air membrane 110 which can be placed inside the airflow chamber housing 1000_AC. In the embodiment of Figure 7A, the air membrane 110 is a circular disc made of a flexible material such as a thin silicone film secured on and inside the breathable surface 1000_AC_b. Figure 7B, shows a disassembled version of the air membrane in the airflow chamber.

[0055] Figure 8 illustrates an exemplary embodiment of the air membrane 110 and how it can move in response to inhaled / exhaled respiration, where the arrows show the respective directions of inhaled / exhaled air. Figure 8A shows an example of the air membrane 110, where strong exhaled air pushes the membrane to close opening 100b and the membrane directs air out of the air outlet 100AC_c. Figure 8B shows the membrane position in a normal tidal inhale / exhale, where the Membrane is bent inward so it lets the inhaled and exhaled airflow to go through the opening 100b.

[0056] Figure 9 illustrates an exemplary embodiment of the airflow chamber where the airflow chamber has a stable housing to rest on the stoma including the medical graderespiration barrier to protect the airway during or after voice generation (Figure 9A) and a detachable housing (that includes the movable air member 110; not shown) (Figure 9B). Figure 9C is the assembled version of this embodiment when attached to the stoma attachment.

[0057] Figure 10 is an exemplary embodiment of the airflow chamber where the voice air outlet 100AC_c is detachable via, for example, a magnetic detachable coupling enabling portable use of the voice generation system 100.

[0058] Figure 11 illustrates an exemplary embodiment of the airflow chamber with the enclosed water trap 100_AC_WT to remove condensation.

[0059] Figure 12 is an exemplary embodiment of the Airflow duct 133 which provides the communication between the airflow chamber 100AC and the voice chamber 100VC.

[0060] Figure 13 shows a preferred embodiment of the voice generation system 100 with all modules assembled and in communication with the neck stoma and the mouth, where the system may or may not be handsfree. The figure is an example of the voice generation system 100 with handsfree function which eliminates a user’s need to hold the device manually.

[0061] Figure 14 shows an example embodiment of the voice chamber 100VC and the Oral Adapter lOOd which is in communication with the oral cavity of the user.

[0062] Figure 15 shows a preferred assembled embodiment of the voice generation system 100, where an air membrane 110 and a voice membrane 120 interact together to provide the system with bi-directional breathing and voice generation modes.

[0063] Figure 16 illustrates an example embodiment of the voicebox chamber (a.k.a., voice chamber) 100VC. Figure 16A shows the voicebox chamber 100VC comprised of a first opening 100VC_a and a second opening (open-end voice outlet) 100c (which can be in communication with the human mouth) and a membrane holder 120VC. Figure 16B illustrates the air movements inside the voicebox chamber with arrows showing air movement directions. Figure 16C shows example implementations of the voice membrane 120.

[0064] Figure 17A illustrates an example embodiment of voice membrane 120 with a disc shape secured on a membrane holder 120VC, where the membrane sits inside the membrane holder in a resting position (with the center part to be free and ready to vibrate). Figure 17B illustrates an example embodiment where the membrane holder 120VC includes a mesh structure 1203 VC to convert potential jet airflows inside the device to laminar streams of air suitable to generate a steady force to vibrate the membrane 120 with arrows showing air movement directions.

[0065] Figure 18 illustrates example embodiments of the membrane holder 120VC to be configured to generate, for example, a male or a female voice. Figure 18A shows an example of a female sounding membrane holder, Figure 18B shows an example male sounding membrane holder.

[0066] Figure 19 shows an example of the measured flat / semi flat harmonic spectrum of the voice generation system 100, which has resulted in an exceptional voice quality for the user.

[0067] Figure 20 shows a preferred embodiment of voice generation system 100 which provides hands-free function. In the embodiment of Figure 20A the voice chamber 100 VC is designed to be secured on or around the ear as a headset wherein the airflow chamber 100AC is in communication with the neck stoma of the user. Figure 20B shows the embodiment of Figure 20 A when worn on the user’s ear.

[0068] Figures 21-24 show preferred embodiments of the medical grade respiration barrier 105 when implemented as a heat and moisture exchanger or HME (HM100) which can be part of the voice generation system.

[0069] Specifically, Figure 21 shows an example medical grade respiration barrier 105 as an HME cassette (HM100) that sits between the medical grade stoma attachment 130 and is compatible with different diameters of these stoma attachments 130. Figure 21A shows an example HME that is compatible with a 22 mm or 23 mm diameter stoma attachment 130. The HME cassette (HM100) can be rotated to be used with the stoma attachment 130 with compatible diameter on one end of the HME while the air chamber is connected to the other end of the HME. Figure 2 IB shows an HME cassette (HM100) where the upper and lower (HMlOOu, HMlOOd, respectively) parts can detach to include the HME foam (HM1001 heat and moisture absorbent material).

[0070] Figure 22 shows an example of the HME cassette (HM100) where the cassette includes a barrier HM1002 to stop or redirect phlegm / sputum generated inside the stoma during for example coughing existing the stoma so that these cannot block the HME foam HM1001 and enable the breathing though the foam not to be blocked by the phlegm / sputum. Figure 22B shows the parts of this design and Figure 22C shows how the cassette (HM100) sits between the airflow chamber 100AC and the medical grade stoma attachment 130.

[0071] Figure 23 shows an example of how the HME (HM100) can be custom designed to be connected to the airflow chamber 100AC. The airflow chamber can be designed to attach or detach to existing HMEs. Alternatively, the device can be custom designed to fit its own HME as demonstrated.

[0072] Figure 24 shows another example of how the airflow chamber 100AC and the HMEcassette HM100 can connect where HM100 is attachable or detachable to the airflow chamber via a thread mechanism (100AC_tr).DETAILED DESCRIPTION

[0073] The following modes, given by way of example only, are described in order to provide a more precise understanding of the subject matter of an embodiment or embodiments of this invention. In the figures, incorporated to illustrate features of an example embodiment, like reference numerals are used to identify like parts throughout the figures.

[0074] This invention describes a respiratory driven voice generation system which generates a voice component and / or an airflow component for a user. The system acts as an artificial voice (and / or an airflow) source for the person to replace the voice generation function of the vocal folds. The system can generate a voice of an exceptional quality for a voice-loss person who may have lost, damaged, or bypassed their larynx including but not limited to people who undergo laryngectomy or tracheostomy.

[0075] General embodiments of the voice generation system will now be described with reference to Figures 2 A and 2B and 2C.

[0076] Referring to Figure 2A, there is illustrated a voice generation system 100 which comprises at least a first opening 100a, a second opening 100b and a third opening 100c. The first opening 100a and second opening 100b act as air inlets / outlets and the third opening 100c acts as an open-end voice outlet. Referring to Figure 2A, there is illustrated a voice generation system 100 with the first opening in communication with the neck stoma of the user, the second opening 100b in communication with open air and the third opening 100c in communication with the oral cavity of the user.

[0077] Referring to general embodiments of Figure 2A, the first opening of voice generation system 100 can be in communication with the stoma via a medical grade barrier 205 which is not part of the device.

[0078] Voice generation system 100 further comprises an airflow chamber 100AC and a voice chamber 100VC, wherein the airflow chamber 100AC is in communication with the first opening 100a, second opening 100b and the voice chamber 100VC. voice generation system 100 further comprises a voice chamber 100VC which is in communication with the airflow chamber 100AC and the third opening 100c. voice generation system 100 further comprises and defines an air passage, airflow channel, or airflow duct 133 that moves the air from the air chamber to the voice chamber and a bidirectional air passage, air channel, or airduct 144 that transfers the air between the air chamber AC and the third opening 100c.

[0079] Referring to Figure 2A, there is illustrated a voice generation system 100, where airflow chamber 100 AC further comprises a first opening 100a (air inlet / outlet), the second opening 100b (air inlet / outlet) and a third opening (air outlet) 100AC_c. The airflow chamber 100 AC further comprises an airflow movable member 110, where the airflow movable member 110 acts as a multi-directional air valve inside the airflow chamber 110 and redirects the air between the first opening 100a, second opening 100b and the air outlet 100AC_c.

[0080] In some embodiments of Figure 2 A, the airflow chamber first opening 100a is in communication with the neck stoma of a patient via a medical grade respiration barrier (not part of the device) as the interface and receive and access the inhaled and exhaled airflow of the stoma travelling through the first opening 100a. In some embodiments the airflow chamber second opening 100b can be in communication with and receive open air and the airflow chamber third opening 100AC_c is in communication with the voice chamber via the airflow duct 133.

[0081] Voice generation system 100 of Figure 2A further comprises and defines an air passage, airflow channel, or airflow duct 133 that moves the air from the air chamber third opening (air outlet) 100AC_c to the voice chamber.

[0082] Referring to Figure 2A, there is illustrated a voice generation system 100, where the voice chamber 100VC further comprises a voice movable member 120 where the voice movable member 120 is configured to vibrate in response to air flowing inside the voice chamber 100 VC.

[0083] In the general embodiment of Figure 2A, the voice movable member 120 generates a voice in response to variations in air pressure at the first opening 100a of the voice generation system 100 and the third opening 100c. Referring to Figure 2A, the pressure at or close to the first opening 100a corresponds to the respiratory pressure at or close to the neck stoma and the pressure at or close to the third opening 100c corresponds to the respiratory pressure inside or close to the oral cavity of the user.

[0084] Referring to Figure 2A, there is illustrated a voice generation system 100, which includes an airflow chamber 100AC, where the first opening 100a of the airflow chamber is in communication with a medical grade respiration barrier 205 and the medical grade respiration barrier 205 is in communication with the stoma. In some embodiments of Figure 2 A the first opening 100a of the airflow chamber can attach or detach to a medical grade respiration barrier 205, where the medical grade respiration barrier is not part of the device, and it is disposable and replaceable. In some embodiments of Figure 2A the first opening100a of the airflow chamber can seal over a medical grade respiration barrier 205, where the medical grade respiration barrier is not part of the device, and it is disposable and replaceable. In some embodiments of Figure 2A, voice generation system 100 is not in direct contact with the stoma as the medical grade respiration barrier acts as the interface between the first opening 100a and any communication with the stoma.

[0085] Referring to the general embodiment of Figure 2B, there is illustrated a voice generation system 100 that comprises at least a first opening 100a (air inlet / outlet), a second opening 100b (air inlet / outlet) and a third opening 100c which acts as an open-end voice outlet. Referring to Figure 2B, there is illustrated a voice generation system 100 with the first opening in communication with the neck stoma and receives inhaled and exhaled airflow from the stoma. The second opening 100b is in communication with open air and the third opening 100c is in communication with the oral cavity of the user.

[0086] Referring to general embodiments of Figure 2B, the first opening 100a of voice generation system 100 can be in communication with the stoma via a medical grade barrier 205 which included as part of the device.

[0087] Referring to the general embodiment of Figure 2B, voice generation system 100 further comprises an airflow chamber 100 AC and a voice chamber 100VC, where the airflow chamber 100 AC is in communication with the first opening 100a and second opening 100b and the voice chamber 100VC. voice generation system 100 further comprises a voice chamber 100VC which is in communication with the airflow chamber 100AC and the third opening 100c. voice generation system 100 further comprises and defines an air passage, air channel, or airflow duct (a.k.a., flow tube) 133 that moves the air from the air chamber 100 AC to the voice chamber and a bidirectional air passage, air channel, or air duct 144 that directs the air between the air chamber AC and the third opening 100c. voice generation system 100 further comprises a first opening 100a and second opening 100b which act as air inlets / outlets and a third opening 100c (open-end voice outlet) which acts as a voice outlet in communication with the oral cavity of the user such that during use, the air pressure at or near the voice outlet 100c corresponds to an air pressure in the oral cavity of the user.

[0088] Referring to Figure 2B, there is illustrated a voice generation system 100, where airflow chamber 100 AC further comprises a first opening 100a, a second opening 100b and a third opening (air outlet) 100 AC_c. The airflow chamber 100 AC further includes a medical grade respiration barrier 105 and an airflow movable member 110 where the airflow movable member 110 is configured to redirect the air inside the airflow chamber 110 as a multidirectional air valve between the first opening 100a (air inlet / outlet), second opening 100b(air inlet / outlet) or the third opening (air outlet) 100AC_c.

[0089] In the general embodiments of Figure 2B, the airflow chamber first opening 100a is in communication with the neck stoma of a patient via a medical grade respiration barrier 105 included in or as part of the airflow chamber, with the medical grade respiration barrier 105 as an interface to the airflow chamber to receive and access the stoma inhaled and exhaled airflow. In some embodiments the airflow chamber second opening 100b can be in communication and receive open air and the airflow chamber third opening 100AC_c is in communication with the voice chamber via the airflow duct 133.

[0090] Referring to the general embodiment of Figure 2B, voice generation system 100 further comprises and defines an air passage, airflow channel, or airflow duct 133 that moves the air from the air chamber third opening (air outlet) 100AC_c to the voice chamber.

[0091] In the general embodiment of Figure 2B, the voice movable member 120 generates a voice in response to variations in air pressure at first opening 100a of the voice generation system 100 and the third opening 100c. Referring to Figure 2A, the pressure at or close to the first opening 100a corresponds to the respiratory pressure at or close to the neck stoma and the pressure at or close to the third opening 100c corresponds to the respiratory pressure inside or close to the oral cavity of the user.

[0092] Referring to Figure 2B, voice generation system 100 further includes a medical grade respiration barrier 105 as part of and included in the voice generation system 100 where airflow entering and exiting from the first opening 100a, passes through the medical grade respiration barrier 105 before entering the rest of the system as the medical grade respiration barrier provides a safe and hygienic communication with the stoma.

[0093] Referring to Figure 2B, there is illustrated an example voice generation system 100, where the medical grade respiration barrier 105 is implemented as a permanent part of the airflow chamber 100 AC where the airflow chamber 100 AC and its included Medical grade respiration barrier can be removed or disposed frequently (such as daily) for hygienic use of the device. In some examples of Figure 2B, the medical grade respiration barrier 105 is included airflow chamber 100 AC but it is non-permanent, attachable, detachable or a disposable part of the airflow chamber, where the included medical grade respiration barrier can be removed or disposed frequently (such as daily) for hygienic use, and the airflow chamber can be cleaned and reused for a longer term. In some examples of Figure 2B, the first opening 100a is in communication with a stoma of a voice-loss person using an included medical grade respiration barrier which is a non-permanent, disposable and removable part of the airflow chamber 100AC. This can be for example a disposable medical graderespiration barrier 105 that patients use to protect their stoma which can be included in or removed from in the airflow chamber 100AC.

[0094] In some embodiments of voice generation system 100 in Figure 2B, the airflow chamber and its included medical grade respiration barrier 105, may be in direct communication with the stoma. In some embodiments of voice generation system 100 in Figure 2B, the airflow chamber and its included medical grade respiration barrier 105, may be in communication a stoma attachment where the medical grade respiration barrier attaches or detaches to the stoma attachment. In some embodiments of voice generation system 100 in Figure 2B, the airflow chamber and its included medical grade respiration barrier 105, may be in communication a stoma attachment where the medical grade respiration barrier seals over the stoma attachment. In some embodiments of voice generation system 100 in Figure 2B, the airflow chamber and its included medical grade respiration barrier 105, may be in communication a stoma attachment where the airflow chamber connects or partially penetrates the stoma attachment.

[0095] Referring to Figure 2C, there is illustrated another general embodiment of the Voice Generation System and method 100 which includes some or all of the components of Figures 2 A and 2B. Referring to general embodiments of Figure 2C, the first opening 100a of voice generation system 100 as disclosed in this invention can be in communication with the stoma via a medical grade barrier 205 which included as part of the device. Referring to example embodiments of Figure 2C, voice generation system can further include a medical grade stoma attachment 130 included as part of the device.

[0096] The general embodiments of Figure 2C further include a medical grade stoma attachment 130 to be included as part of the Voice Generation System 100 to cover or connect the system to the patient stoma. Referring to Figure 2C, there is illustrated a voice generation system 100 with the first opening 100a in communication with a medical grade stoma attachment 130 as part of the device, where the patient uses the stoma attachment 130 to cover or connect the device to their stoma. Referring to Figure 2C, there is illustrated a voice generation system 100 with the first opening 100a in communication with the medical grade stoma attachment 130 as part of the device. Referring to Figure 2C, voice generation system 100 is in direct contact with the stoma where via the stoma attachment 130 as part of the device. Referring to Figure 2C, voice generation system 100 further includes a medical grade respiration barrier 105 to maintain a safe and hygienic connection to the stoma.

[0097] In some embodiments as described in Figure 2C, the stoma attachment 130 can include a medical grade attachment or substrate included in the voice generation system andmethod 100 to cover or connect the device to the stoma wherein the substrate is attached to the skin around the neck stoma of a human subject. The stoma attachment substrate 130 can include self-adhesive, wherein the substrate connects to the skin around the neck stoma of a human subject similar to for example a laryngectomy baseplate. In some embodiments as described in Figure 2C, the stoma attachment 130 can include a medical grade attachment or substrate that can penetrate partly or deeply inside stoma for example similar to a laryngectomy, lary-button, or larytube). In some embodiments, the substrate 130 can have an extension partially penetrating the neck stoma like tracheostomy tubes widely used tracheostomy users. In some embodiments, the substrate 130 can be disposable and changed frequently (such as daily) for hygienic use of the device.

[0098] Referring to example embodiments, the general embodiments of voice generation system 100 as disclosed in this invention include an airflow chamber 100AC, an air duct, 133 a voice chamber 100VC, and an Oral Adapter lOOd.

[0099] The following modes, given by way of example only, are described in order to provide a more precise details about the different components of the subject matter of the voice generation system 100 and its an embodiment or embodiments.Communication with the stoma

[0100] Referring to Figure 3, laryngectomy or tracheostomy patients who use the voice generation system 100, may use a stoma attachment substrate to cover or protect their stoma or to connect the device to their stoma. Some examples of the stoma attachment used by laryngectomy or tracheostomy patients that may be used to connect the voice generation system 100 to the stoma are shown in Figure 3. Figure 3A includes an adhesive stoma attachment, wherein the stoma attachment substrate 200a is attached to the skin around the neck stoma of a human subject. The stoma attachment 200 can include a self-adhesive substrate which connects to the skin around the neck stoma of a subject including or similar to, for example, a laryngectomy baseplate. In some examples as depicted by Figure 3B, the stoma attachment substrate can penetrate partly or deeply inside stoma for example a laryngectomy, lary-button, or larytube (Figure 3B). In some examples, the substrate can have an extension partially penetrating the neck stoma including but not limited to tracheostomy tubes widely used tracheostomy users.

[0101] In some examples, the stoma attachment substrate can include a connecting aperture 210, where the connecting aperture 210 is configured to receive and hold a medical grade respiration barrier 205 to protect the stoma and airway from external particles such as dirt orbacteria. In some embodiments, the medical grade respiration barrier 205 can be a Heat Moisture Exchanger (HME).

[0102] Referring to the voice generation system 100, in some embodiments the first opening 100a of the voice generation system 100 is in communication with the neck stoma of the patient via communication with a stoma attachment 200. In some example embodiments of Figure 2A or 2B the stoma attachment 200 may be off the shelf and not part of the device such as for example a lary-button, or a baseplate, tracheostomy tube used by laryngectomy or tracheostomy patients. In some example embodiments as shown in Figure 2C, the stoma attachment 130 is included and part of the voice generation system 100.

[0103] Referring to voice generation system 100 in Figure 2A, in some embodiments the first opening 100a of the voice generation system 100, is in communication with the stoma attachment where the stoma attachment 200 is connected to a medical grade respiration barrier 205, where the stoma attachment 200 and medical grade respiration barrier 205 are of the shelf, independent and not part of the device. In some embodiments, the stoma attachment can include an adhesive substrate, wherein the substrate is attached to the skin around the neck stoma of a human subject. In some embodiments, the substrate can include self-adhesive, wherein the substrate connects to the skin around the neck stoma of a human subject including for example a laryngectomy baseplate (Figure 3A). In some embodiments, the substrate can penetrate partly or deeply inside stoma, for example, a lary-button (Figure 3B) or larytube. In some embodiments, the substrate can have an extension partially penetrating the neck stoma for example tracheostomy tubes widely used tracheostomy users. In some examples, the stoma attachment 200 substrate can include a connecting aperture 210, where the aperture is configured to hold a medical grade respiration barrier 205 to protect the stoma and airway from external particles such as dirt or bacteria. In some embodiments, the medical grade respiration barrier device can be a Heat Moisture Exchanger (HME) including a handsfree heat moisture exchanger (HME) disc used to connect other devices to the neck stoma.

[0104] Referring to Figure 2A, in some embodiments, the voice generation system 100 comprises a first opening 100a which is in communication with the stoma where the first opening 100a is placed around and outside stoma attachment 200 without physical connection to the stoma. In some embodiments the first opening 100a is placed around and outside stoma attachment 200 when the stoma attachment aperture 210 is connected to a medical respiration barrier 205 to cover the stoma. In some embodiments the first opening 100a seals over the stoma or the stoma attachment when the stoma attachment aperture 210is connected to a medical respiration barrier 205 and the first opening 100a is not directly connected to attached to the stoma attachment 200, the stoma attachment aperture 210 or medical respiration barrier 205. Referring to Figure 2 A, in some embodiments, the first opening 100a is placed around stoma attachment 200 when the stoma attachment is connected to the medical respiration barrier 205 without direct contact to stoma attachment 200 or medical respiration barrier 205.

[0105] Referring to Figure 2A, voice generation system 100 comprises a first opening 100a, which is in communication with the stoma. In some embodiments the first opening 100a, is in communication with the stoma where the stoma is covered by a stoma attachment 200 connected to a medical grade barrier 205 not part of the device. In some embodiments the first opening 100a of the voice generation system 100 receives the medical grade barrier 205 (not part of the device) and maintains direct attachment to it. In some embodiments the first opening 100a, can be attached or detached to the medical barrier (not part of the device) when needed.

[0106] Referring to Figure 2A, voice generation system 100 can seals against, clips or connect to the medical grade barrier 205 (not part of the device) where the medical grade barrier 205 can for example be connected or coupled to or seal against the stoma attachment aperture 210. Referring to Figure 2A, in some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma attachment, using the medical grade barrier 205 as an interface. Referring to Figure 2A, in some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma attachment, using the medical grade barrier 205 as a safe interface, where the medical grade barrier 205 is connected to both the voice generation system 100, first opening and the stoma attachment aperture 210. Referring to Figure 2A, in some embodiments voice generation system 100, both the medical grade barrier 205 and the stoma attachment are not part of the device and are disposable and replaceable for maximum hygiene. Referring to Figure 2A, in some embodiments voice generation system 100, using the medical grade barrier 205 as the interface is not in direct contact with the airway to maximize its safety and hygiene. Referring to Figure 2A, in some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma attachment, using the medical grade barrier 205, where the medical grade barrier 205 is an HME. Referring to Figure 2A, in some embodiments the medical grade respiration barrier includes a handsfree HME cassette used to connect other hands-free devices to the stoma attachment for laryngectomy or tracheostomy people.

[0107] Referring to Figure 2A, in some embodiments voice generation system 100 maintainsa direct and hygienic connection to the stoma, using the external medical grade barrier 205 as an interface where the exhaled air exiting from the stoma passes through the first opening 100a passes through the medical grade barrier 205 (not part of the device) first before entering the rest of the voice generation system 100. In some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma, using the external medical grade barrier 205 as an interface where the inhaled air passing through the voice generation system 100 passes through the medical grade barrier first before entering the stoma.

[0108] Referring to Figure 2 A, in some embodiments voice generation system 100 as disclosed herein includes a first opening 100a which is adjustable to fit medical grade respiration barrier 205 (not part of the device) that can fit stoma attachment 200 substrates with different aperture sizes 210, and different stoma attachments including for example adhesive or penetrative stoma attachments. This enables the device to work widely with people with different stoma shapes, sizes, stoma locations and bone structures.

[0109] Referring to Figure 2B, voice generation system 100 comprises a medical grade barrier which is included as part of or inside as part of the device. Referring to Figure 2B, voice generation system 100 comprises a medical grade barrier 105 which is implemented as a permanent part of the device. Referring to Figure 2B, voice generation system 100 comprises a medical grade barrier 105 which is implemented as a disposable part of the device.

[0110] Referring to Figure 2B, voice generation system 100 comprises a medical grade barrier 105 which is part of the device and in communication with the first opening 100a, which is in communication with the stoma. In some embodiments the first opening 100a, is in communication with the stoma where the stoma is covered by a stoma attachment 200 not part of the device.

[0111] Referring to Figure 2B, in some embodiments, voice generation system 100 comprises a medical grade barrier 105 which is part of the device and in communication with the first opening 100a where the first opening 100a is placed around and outside stoma without physical connection to the stoma. In some embodiments the first opening 100a is placed around and outside stoma where the first opening 100a is not directly attached to the stoma.

[0112] Referring to Figure 2B, voice generation system 100 comprises a medical grade barrier 105 which is part of the device and in communication with the first opening 100a where the first opening 100a is in communication with the stoma attachment 200. In someembodiments of Figure 2B, voice generation system 100 seals against, clips or penetrates the stoma attachment aperture 210, where the stoma attachment (not part of the device) can include an adhesive substrate, wherein the substrate is attached to the skin around the neck stoma of a human subject. In some embodiments of Figure 2B, first opening 100a, seals against, clips or penetrates the stoma attachment aperture 210, where the stoma attachment (not part of the device) can include self-adhesive, wherein the substrate connects to the skin around the neck stoma of a human subject including for example a laryngectomy baseplate (Figure 3 A). In some embodiments of Figure 2B, first opening 100a seals against, clips or penetrates the stoma attachment aperture 210, where the stoma attachment 200 can penetrate partly or deeply inside stoma for example a lary-button (Figure 3B) or larytube. In some embodiments, first opening 100a seals against, clips or penetrates the stoma attachment aperture 210, where the stoma attachment can be example tracheostomy tubes widely used tracheostomy users.

[0113] Referring to Figure 2B, in some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma, using the internal medical grade barrier 105 as an interface where the exhaled air from the stoma passing through the first opening 100a passes through the medical grade barrier first before entering the rest of the voice generation system 100. In some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma, using the internal medical grade barrier 105 as an interface where the inhaled air from the stoma passing through the voice generation system 100 passes through the medical grade barrier first before entering the stoma. Referring to Figure 2B, in some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma attachment, using the medical grade barrier 105, where medical grade barrier 105 acts as a safe interface between the device and stoma when the device is in direct contact with the airway to maximize its safety and hygiene. Referring to Figure 2B, in some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma attachment, using the medical grade barrier 105, where the medical grade barrier 105 can function similar to an HME.

[0114] In some embodiments of Figure 2B, the medical grade respiration barrier 105 is a detachable and removable part of the device. For example, the medical grade respiration barrier 105 can be disposable part of the device for daily use. In some examples voice generation system 100 comprises a medical grade barrier 105 which is implemented as a permanent part of the device.

[0115] Figures 21-24 show preferred embodiments of the medical grade respiration barrier105 when implemented as a heat and moisture exchanger or HME (HM100) as part of the voice generation system as described in Figure 2B. The HM100 in some examples includes a medical grade foam (HM1001) which may be impregnated with heat and moisture absorbent material to absorb moisture and keep respirated air warm.

[0116] Figure 21 includes variations of (HM100) where the HME cassette (HM100) sits between the medical grade stoma attachment 130 and is compatible with different diameters of these stoma attachments 130.

[0117] Figure 22 shows an example of the HME cassette (HM100) as a detachable or included part of the device where the cassette includes a barrier HM1002 that stops or redirect phlegm / sputum exiting the stoma for example because of coughing, so that the phlegm / sputum cannot block the HME foam HM1001 and breathing though the foam not to be interrupted by the phlegm / sputum contaminating the foam.

[0118] Figure 23 shows an example of how the HME (HM100) can be custom designed to be connected to the airflow chamber 100AC. The airflow chamber can be designed to attach or detach to pre-existing medical grade respiration barriers. Alternatively, the device can be custom designed to connect to its compatible HME as demonstrated in this figure.

[0119] Referring to Figure 2B, in some embodiments voice generation system 100 as disclosed herein can include a medical grade barrier 105 (as part of the device) that is adjustable to respiration powers of different users, where respiration power of the user is measured using spirometry. For example, medical grade barrier 105 density can be quantized to less dense for people with high respiration power, to denser for people with low respiration power to provide easier breathing for the patient through the device where respiration power of the user is measured using spirometry.

[0120] For explanatory purposes, the respiration effort (a.k.a., respiration power) of the user corresponds to their exhalation performance, which can be evaluated using the measurements of exhaled air pressure and airflow through standard methods including spirometry. The spirometry parameters to measure include tidal and forced respiration pressure ranges which can be measured in kPa, using a pressure sensor suitable for respiration pressure monitoring (such as NXP MPX Series pressure sensors which can measure respiration pressures up to 4 kPa, up to 6 kPa, up to 10 kPa, or up to 15 kPa) for tidal and forceful breathing. The other significant parameter to quantize different people’s respiration effort in speech is the peak respiratory airflow of the user exhaling from the stoma (measured in liters per minute, FPM) which can be measured using for example a Sensirion differential pressure sensor SDP series or Sensirion flow meter SFM series which can measure peak respiratory airflow of differentsubjects in speech which can be calibrated to measure up to 6 liters per minute, up to 10 liters per minute, or up to 15 liters per minute or up to 20 liters per minute.

[0121] The voice generation system 100 can be customized to function for people at respiration efforts (as measured by respiration pressure or airflow) corresponding to 1.1 times their tidal breathing levels, 1.2 times their tidal breathing levels, to 1.3 of their tidal breathing levels, to 1.4 times their tidal breathing levels, to 1.5 times their tidal breathing levels, to larger values compared to their tidal breathing levels.

[0122] Referring to Figure 2B, in some embodiments voice generation system 100 as disclosed herein includes a medical grade respiration barrier 105 (part of the device) that can fit stoma attachment 200 substrates with different aperture sizes 210 and different stoma attachments including for example adhesive or penetrative stoma attachments. This enables the device to work widely with people with different stoma shapes, sizes, stoma locations and bone structures.

[0123] Referring to Figure 2C, voice generation system 100 further includes a medical grade barrier 105 and a stoma attachment 130 as part of the device. In some embodiments the first opening 100a of the voice generation system 100, is in communication with the stoma using a stoma attachment 130 connected to a medical grade respiration barrier 105, where the stoma attachment 130 and medical grade respiration barrier 105 are part of the device. In some embodiments, the stoma attachment 130 can include an adhesive substrate, wherein the substrate is attached to the skin around the neck stoma of a human subject. In some embodiments, the substrate 130 can include self-adhesive, wherein the substrate connects to the skin around the neck stoma of a human subject including for example including or similar to a laryngectomy baseplate (Figure 3A). In some embodiments, the substrate 130 can penetrate partly or deeply inside stoma for example including or similar to a lary-button (Figure 3B) or larytube. In some embodiments, the substrate can have an extension partially penetrating the neck stoma for example tracheostomy tubes widely used tracheostomy users.

[0124] Referring to Figure 2C, in some embodiments the first opening 100a, is in communication with the stoma where the stoma is covered by the stoma attachment 130 which is implemented to connect the device to the neck stoma. In some embodiments of Figure 2C, the stoma attachment 130 is a detachable part of the device. In some embodiments of Figure 2C, the stoma attachment is a disposable part of the device for daily or longer-term use. The voice generation system 100 comprises a medical grade barrier 105 which is implemented as a permanent part of the device. Referring to Figure 2C, voice generation system 100 comprises a medical grade barrier 105 and a stoma attachment 130 which areimplemented as a disposable part of the device.

[0125] Referring to Figure 2C, in some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma, using the medical grade barrier 105 and the medical grade stoma attachment 130 as part of the device where the exhaled air from the stoma passing through the stoma attachment 130 to reach the first opening 100a, passing through the medical grade barrier 105 (part of the device) first before entering the rest of the voice generation system 100. In some embodiments voice generation system 100 maintains a direct and hygienic connection to the stoma, using the stoma attachment 130 and the medical grade barrier 105 as an interface where the inhaled air from the stoma passing through the voice generation system 100 passes through the medical grade barrier first before entering the stoma.

[0126] Referring to Figure 2C, in some embodiments voice generation system 100 as disclosed herein includes a medical grade respiration barrier 105 or the stoma attachment 130 aperture size and shapes that are adjustable to respiration powers of different users, where respiration power of the user is measured using spirometry. For example, medical grade barrier 105 shape can be quantized to fit people with low, medium or high respiration power where respiration power of the user is measured using spirometry. In some embodiments voice generation system 100 as disclosed herein includes a first opening 100a which is adjustable to fit stoma attachment 130 substrates with different aperture sizes 210 and different stoma attachments including for example adhesive or penetrative stoma attachments. This enables the device to work widely with people with different stoma shapes, sizes, stoma locations and bone structures.

[0127] For explanatory purposes, respiration effort (a.k.a., respiration power) of the user correspond to their exhalation performance, which can be evaluated using the measurements of exhaled air pressure and airflow through standard methods including spirometry. The parameters to measure include respiration pressure range which can be measured in kPa, using a pressure sensor suitable for respirasome pressure monitoring (such as NXP MPX Series pressure sensors which can measure respiration pressures up to 4 kPa, up to 6 kPa, up to 10 kPa, or up to 15 kPa). The other significant parameter to quantize different people’s respiration effort in speech is the peak respiratory airflow of the user exhaling from the stoma (measured in liter per minute, LPM) which can be measured using for example Sensirion differential pressure sensor SDP series or Sensirion flow meter SFM series which can measure peak respiratory airflow of different subjects in speech which can be up to 6 liters per minute, up to 10 liters per minute, or up to 15 liters per minute or up to 20 liters perminute.

[0128] Respiration efforts in speech is generally less than the peak respiratory airflow / pressure of a person and closer to the values corresponding to the tidal breathing, wherein the voice generation system 100 is customized to function for people at respiration efforts (as measured by respiration pressure and airflow) corresponding to 1.1 times their tidal breathing levels, 1.2 times their tidal breathing levels, to 1.3 of their tidal breathing levels, to 1.4 times their tidal breathing levels, to 1.5 times their tidal breathing levels, to larger values compare to their tidal breathing levels.Airflow chamber

[0129] In some embodiments, voice generation system 100 as disclosed herein, can comprise an airflow chamber 100AC. Referring to Figure 4A. In some embodiments, airflow chamber 100AC as disclosed herein can comprise a first opening 100a (air inlet / outlet) which is in communication with the stoma or stoma attachment 200 of the subject. In some embodiments, the housing 100AC as disclosed herein can comprise a second opening 100b (air inlet / outlet) which is in communication with the open air. In some embodiments, airflow chamber comprises a third opening 100AC_c (air outlet) which is in communication with the voicebox chamber 100 VC. In some embodiments, airflow chamber comprises a fourth opening which is in communication with the open air. In some embodiments, airflow chamber comprises a fourth opening 100AC_d (air_window) which is in communication with the open air using a movable window. In some embodiments, airflow chamber comprises more than four openings.

[0130] In some example embodiments as illustrated in Figure 4B, the airflow chamber comprises a housing enclosure 1000_AC which includes the first opening 100a and third opening 100AC_c and a breathable surface 1000_AC_b which shapes the second opening 100b. In some example embodiments, the airflow chamber comprises a housing enclosure 1000_AC and a breathable surface 1000_AC_b where the housing 1000_AC forms an air passage including a first opening (air inlet / outlet) 100a and a second opening 100b through the breathable surface 1000_AC_b, a third opening 100AC_c (air outlet) or more openings.

[0131] In some embodiments, the airflow chamber 100AC as disclosed herein is in communication with the stoma attachment 200, for example adhesive or penetrative stoma attachments 200 that are not part of the device. In some embodiments, the airflow chamber 100AC is in communication with the stoma attachment 130 (Figure 2C) which is part of the device. In some embodiments, the airflow chamber is washable and or disposable tomaximize its hygiene. In some embodiments the airflow chamber 100AC is disposable after a set period of time, from one day to several months.

[0132] In some embodiments, the airflow chamber first opening 100a is in communication with the stoma attachment substrate using a medical grade respiration barrier. In some embodiments, the airflow chamber 100 AC first opening 100a can comprise a connecter piece. In some embodiments, the airflow chamber connecter piece can couple to the medical grade barrier where the medical grade barrier acts as the interface between the stoma attachment and the airflow chamber and airflow chamber is not in direct contact with the stoma. In some embodiments the medical grade barrier is implemented inside the airflow chamber, where the airflow chamber partially penetrates the connecting aperture of stoma attachment and may be in direct contact with the stoma.

[0133] In some embodiments the airflow chamber first opening 100a connector piece is attached to the medical grade respiration barrier. Referring to Figure 5, the medical grade respiration barrier 105 or 205 is connected to the stoma attachment aperture 210. In some embodiments, medical grade respiration barrier 105 or 205 is attachable or detachable from the first opening 100a. In some embodiments as illustrated in Figure 2A, medical grade respiration barrier 205 is not part of the airflow chamber. In some embodiments as illustrated in Figure 2B or 2C medical grade respiration barrier 105 is part of the airflow chamber. In some embodiments, the medical grade respiration barrier device can be a heat moisture exchanger (HME).

[0134] Referring to the embodiment of Figure 5, there is an example of the airflow chamber where the HME is for example an HME disc 205 which is separable and not part of the device wherein the HME attaches or detached to the first opening 100a of the airflow chamber and the HME is disposable daily, where the airflow chamber can be used on a longer term. In this embodiment the airflow chamber does not enter the stoma attachment and is connected to the stoma attachment via the HME as the interface. In this embodiment the airflow chamber is not in direct contact with the stoma.

[0135] In some embodiments, as illustrated in Figure 6A the medical grade respiration barrier is implemented as an inseparable part of the airflow chamber 100 AC wherein the airflow chamber and its included medical grade respiration barrier 105 are used as a unit. In some embodiments the airflow chamber 100 AC and its inseparable medical grade respiration 105 are disposable daily to maximize their hygiene. In this embodiment the airflow chamber 100AC and its included medical grade respiration 105 barrier enters in part to the stoma attachment and is in direct contact with the air existing the airway through the stoma.

[0136] In some embodiments, as illustrated in Figure 6B the medical grade respiration barrier (105) is separable but is placed inside a reusable airflow chamber 100AC, where the airflow chamber can be opened to add or remove the medical grade respiration barrier (105), where the airflow chamber can be used and cleaned for periods longer than one day, and the medical grade respiration barrier 105 is detachable and disposable on a shorter period such as daily basis. In some embodiments for example as illustrated in Figure 6B, the medical grade respiration barrier is separable but part of the device, where the voice chamber housing can be opened to include the medical grade respiration barrier and dispose it daily after use. In such embodiments the medical grade respiration barrier 105 is used daily but the airflow chamber 100AC can be used on a longer term. In this embodiment the airflow chamber 100 AC and its included medical grade respiration 105 barrier enters in part to the stoma attachment and is in direct contact with the air existing the airway through the stoma.

[0137] In some embodiments, the medical grade respiration barrier (205) is separable and not part of the air chamber (100 AC) where the medical grade respiration barrier 205 is disposable on a shorter period such as daily, where the airflow chamber 100 AC can be used on a longer term. In some embodiments the medical grade respiration barrier 205 is separable but not part of the device, but the device enclosure can be opened to include the medical grade respiration barrier 205 such has an HME and dispose it after use on a shorter period such as daily. In such embodiments the medical grade respiration barrier is used on a shorter period such as daily, but the airflow chamber can be used on a longer term.

[0138] In some embodiments airflow chamber 100 AC is in communication with the neck stoma of a patient and receives inhaled and exhaled airflow from the stoma. In some embodiments, the airflow chamber as disclosed herein can comprise a minimum of three or four-way air valve, wherein the minimum of three or four different modes of usage comprise: automatic inhale and automatic exhale (bidirectional breathing), whereby the user can naturally inhale and exhale without removing the device from the stoma or stoma attachment 200; voice generation when the user exhales more than tidal breathing as an indication of voice onset; and a fourth bypass mode, when the user can disable the device when they need coughing or breathing heavily without removing it from the stoma attachment; In some embodiments, the airflow chamber 100AC as disclosed herein comprises a multiple-way air valve capable of providing more modes of usage.

[0139] In some embodiments, airflow chamber 100AC further comprises a movable air member 120 located within housing 1000AC and configured to stop, facilitate or redirect air flowing inside the chamber through or between some or all of the airflow chamber openingsin the different modes of usage. In some examples, the movable air member 120 is located within airflow chamber 100AC. In some examples, movable air member 120 extends transversely across airflow chamber 100AC, in a direction orthogonal to the flow of air in air chamber between the first 100a and second opening 100b. In some embodiments, the airflow chamber as disclosed is a pressure or airflow-activated movable air member which automatically switches between some or all modes of usage including for example bidirectional breathing, voice generation or bypass modes of the device.

[0140] In some embodiments, breathing mode comprises a subject natural tidal exhale by exhaling air through the stoma through the medical grade respiration barrier to the first opening 100a of the airflow chamber 100AC, wherein the exhaled air passes through the airflow chamber and exists the second opening 100b of the airflow chamber. In some embodiments the movable air member 120 enables automatic exhale mode by permitting the air passage from the first opening 100a to exit the second opening 100b without the need to remove airflow chamber 100 AC from the stoma or stoma attachment 200. In some embodiments, breathing inhale mode comprises a subject natural tidal inhale wherein the inhaled air enters the airflow chamber 100AC through the second opening 100b, passes through the airflow chamber and exists the first opening 100a to move towards the stoma. The inhaled air then moves toward the stoma after passing through the medical grade respiration barrier 105 or 205. In some embodiments the movable member 120 enables automatic inhale mode by permitting or facilitation the air passage from the second opening 100b to the first opening 100a without the need to remove airflow chamber 100 AC from the stoma or stoma attachment 200.

[0141] In some embodiments movable air member 120 is in breathing mode (inhale / exhale) by default when the air entry chamber is in communication with the stoma of the user, letting the patient breathe freely between the first and second opening without the need to remove airflow chamber 100 AC from the stoma or stoma attachment 200. In some embodiments the third opening of the chamber (air outlet) 100AC_c is connected to the voice generation chamber which has a higher pneumatic resistance path compared to the second opening 100b (which is connected to the open air). Hence, so long as the movable member permits the air exiting the second opening 100b in the default breathing mode (inhale / exhale), the air does not exit the air outlet 100AC_c keeping the voice generation chamber disabled.

[0142] In some embodiments, voice generation mode comprises the subject exhaling air from the lungs normally with a higher airflow compared to their tidal exhale which is an indication of voice onset. In some embodiments when the subject exhales higher airflowthrough the stoma through the medical grade respiration barrier 105 or 205 to the first opening of the airflow chamber 100a, wherein the exhaled air has a higher magnitude compared to tidal exhale, the movable air member 120 reacts to the higher airflow and closes the second opening 100b of the chamber. The exhaled air in voice generation mode passes out of the third opening 100AC_c to the voice chamber 100VC which generates voice in response to the exhaled airflow.

[0143] In some embodiments, movable air member 120 can be comprised of a flexible or thin plastic material, in some embodiments movable air member 120 can be comprised of flexible silicone material. In some embodiments, movable air member 120 be comprised of an electronically operated airflow or pressure activated electronic switch which can be for example implemented by a voice coil actuator.

[0144] In some examples, the movable air member 110 included in the airflow chamber is comprised of a flexible membrane (a.k.a., air membrane). In some example embodiments, the air membrane 110 can be placed inside the airflow chamber housing 1000_AC so that the passage of inhaled or exhaled air inside the chamber moves the membrane to close, restrict or open the airflow chamber openings. In some example embodiments as illustrated in Figure 7A, the air membrane 110 can be a circular disc made of a flexible silicone material. In some example embodiments the air membrane 110 is placed inside the airflow chamber housing 1000_AC and is secured to the breathable surface 1000_AC_b. In some example embodiments as illustrated in Figure 7B, the air membrane is secured against an anchor point 1000_AC_an on and inside the breathable surface 1000_AC_b. Figure 7A shows an example of the membrane as a flexible circular disc placed around an anchor point inside and on the breathable surface 1000_AC_b of the airflow chamber for easy replacement of the membrane when needed. In some embodiments including Figure 7B, the breathable surface 1000_AC_b is attachable or detachable from the airflow chamber for easy replacement of the membrane. In some embodiments the air membrane 110 is attachable or detachable from the airflow chamber, and disposable. In some embodiments the membrane is secured on a disposable breathable surface 1000_AC_b where the membrane and the breathable surface 1000_AC_b are disposable together. In some embodiments the airflow chamber is disposable and replicable. In some embodiments the air membrane 110 is washable and replicable.

[0145] In some examples as illustrated for example in Figure 8 A and 8B, the air membrane 110 is secured in an anchor point 1000_AC_an on and inside the breathable surface 1000_AC_b and engaging to the direction of air from second opening 100b where the membrane default position is bent inward when the user inhales or exhales to keep thebreathable surface of second opening 100b open for free bidirectional tidal breathing (Figure 8B). In some examples the membrane is secured on an anchor point on the second opening where the air membrane 110 is pushed to close the breathable surface 1000_AC_b of the second opening 100b (Figure 8 A) when the exhaled airflow has a higher magnitude compared to tidal exhale, redirecting the air to the third opening 100AC_c to the voice generation chamber 100VC for the device to generate voice for the patient.

[0146] In some embodiments, the air membrane 110 of the airflow chamber 100 AC can be adaptive and customizable over a range of materials. In some embodiments, the membrane of the airflow chamber can comprise natural rubber or medical grade silicone. In some embodiments, the air membrane 110 is comprised of a thin silicone film which can be flexible to move in response to respiration. In some embodiments, the membrane of the airflow chamber can be quantified over a range of thicknesses. In some embodiments, the membrane of the airflow chamber comprises a thickness of 0.05 mm to 0.5 mm. In some embodiments, the membrane of the airflow chamber can be quantified over a range of flexibilities (for example durometer ranging from Shore A 10 to 60. In some embodiments the membrane is made of a more rigid or thicker plastic or metal material.

[0147] In some embodiments, the airflow chamber or the air membrane 110 can be quantified over a range of different shapes, material, flexibility, or thickness to match the wide range of respiration power of different people. In some embodiments, the membrane of the airflow chamber can be quantified over a respiration power range of the subject, wherein the respiration power of the subject is as measured by spirometry. In some embodiments the respiration power of the subject is measured by an airflow meter connected to the airflow chamber 100 AC by measuring the peak exhaled airflow in liter / minute for tidal breathing to estimate the threshold of onset of voice generation. The air membrane 110 can be customized to activate the voice chamber air outlet 100AC_c for the device for generate voice for people at comfortable respiration efforts (as measured by tidal respiration pressure or peak respirations airflow) corresponding to 1.1 times their tidal breathing levels, 1.2 times their tidal breathing levels, to 1.3 of their tidal breathing levels, to 1.4 times their tidal breathing levels, to 1.5 times their tidal breathing levels, to larger values compared to their tidal breathing levels.

[0148] In some embodiments the membrane of the airflow chamber is adjusted to initiate air membrane 110 movement when the respiration airflow is increased from tidal breathing to voice onset. In some embodiments the thickness, shape or material of the air membrane 110 of the airflow chamber can be quantified for low, medium or high respiration powers basedon the patient’s measured tidal breathing level compared to the average of human tidal breathing airflow (6 liters per minute). In some example embodiments the thickness of membrane of the airflow chamber is quantified from 0.1-0.3 mm for low (with flexibility of shore A 20-50) to 0.2-0.4 mm for medium (with flexibility of shore A 20-50) or 0.3-0.5 mm (with flexibility of shore A 20-50) for high respiration powers to use more respirations energy for movements for people with larger respiration power compared to the average. In some embodiments the shape of the air membrane 110 and the airflow chamber anchor point 1000_AC_an can be quantified to have a small, medium or larger anchor point for small, medium or large respiration powers for the membrane to move easier for lower respiration powers.

[0149] In some embodiments, the airflow chamber 100AC comprises a movable air member 110 where the movable air member is controlled or assisted by a finger touch mechanism to switch between breathing mode and voiced generation mode. In some embodiments the finger touch mechanism is mechanical such as a placing a spring element inside the air chamber, connected to the anchor 100_AC_b inside the breathable surface 1000_AC_b (for example in Figure 7A) where the user presses the breathable surface 1000_AC_b inwards to close the second opening 100b and direct the exhaled air out of the air outlet 100AC_c for manual control of voice generation mode. The second opening 100b moves back to default position of bidirectional breathing when the finger touch force is removed.

[0150] In some embodiments, the finger touch mechanism is an electronic touch sensor switches the voice generation mode of the device on or off when the user momentarily touches the sensor surface. In some embodiments, the touch sensor switches between voice generation and breathing modes of the device. In some embodiments the touch sensor is located on the airflow chamber 100AC housing or other parts of the device and communicates with the movable air member 110 via a wired connection. In some embodiments the touch sensor is located on the voicebox chamber or other parts of the device and communicates with the movable air member 110 via Bluetooth® connection. In some embodiments the touch sensor initiates the onset of the voice generation mode and a pressure activated switch initiates the voice offset to move the device back to bidirectional breathing when the respiration pressure drops below the threshold of voice offset. In some embodiments the pressure activated switch to resume the device to default respiration mode can be the movable air member 110.

[0151] In some embodiments of Figure 4A, the airflow chamber 100VC as disclosed herein has a bypass mode where the bypass mode is provided by a movable window 100AC_d thatis in communication with the open air. In some example embodiments, the airflow chamber as disclosed herein can comprise a movable window, wherein the movable window 100AC_d can be opened manually to bypass the second opening 200a and the voice generation chamber and allow free bidirectional breathing including coughing or forceful exhale through the window 100AC_d. In some embodiments, the airflow chamber as disclosed herein can comprise a window, wherein when the window is closed, the voice generation system 100 maintains the standard bidirectional and voice generation modes. In some embodiments, the airflow chamber as disclosed herein can comprise a window, where the user can open the window when feeling distressed or uncomfortable to bypass the device and allow free breathing. In some embodiments, the airflow chamber as disclosed herein can comprise a window, where the user can open the window so that excessive exhale such as cough or forceful breathing does not engage the voice generation chamber.

[0152] In some example embodiments of Figure 4B, the movable window 100AC_d can be implemented in the airflow chamber on the housing enclosure 1000_AC. In some example embodiments, the movable window can be implemented on the breathable surface 1000_AC_b or combination of the housing enclosure 1000_AC and the breathable surface 1000_AC_b. As described in Figure 4B, the airflow chamber housing 1000_AC can include a window 1000_AC_wl and the breathable surface 1000_AC_b can have a movable wall 1000_AC_wl which can rotate inside the housing enclosure 1000_AC and around its axis to open or close the window 1000_AC_wl.

[0153] In some embodiments the movable window can be for example implemented on the breathable surface 1000_AC_b without the need for a fourth opening. In some embodiments the breathable surface 1000_AC_b for example can rotate with a thread mechanism insider the airflow chamber housing 1000_AC and can have a movable attachment that moves inside the breathable surface 1000_AC_b and increases the distance between the membrane 1010 and breathable surface 100AC_b to increase the distance of membrane 1010 and breathable surface 100AC_b letting the air out of breathable surface 100AC_b and the keeping the movable member in the permanent open position to keep the second opening 100b open and bypass the air outlet 1000_AC_c. In some embodiments the fourth opening can be embedded in the breathable surface 1000_AC_b by other mechanisms such as rotating the breathable surface 1000_AC_b to increase its air outlet mesh size to become larger than the movable air member 110 for the air to scape freely without engaging the movable air member 110 in the bypass mode.

[0154] In some embodiments, the airflow chamber 100AC comprises a movable windowwhere the movable window is driven by a finger touch mechanism to switch between bypass mode and voice / breathing modes. In some embodiments the finger touch mechanism is mechanical such as a placing a spring element inside the air chamber, connected to the breathable surface 1000_AC_b preferably in disc shape where the user releases the breathable surface 1000_AC_b outwards to lock an air gap between the air chamber housing 1000 AC and second opening 100b to serve as an open window for easy breathing (bypass mode) and direct inhaled / exhaled air and heavy airflow / coughs in and out of the air gap in the second opening 100b. The airgap can be closed and the second opening 100b moves back to default position of bidirectional breathing / voice modes, by using finger touch force to push the breathable surface 1000_AC_b inwards to lock second opening 100b in the default position.

[0155] In some embodiments, attaching or detaching the airflow chamber (including its connection to the medical grade respiration barrier) from or to the stoma attachment 200 may expose the patient’s stoma and generate a bio-safety risk of unprotected stoma. In some embodiments as illustrated in Figure 9, the airflow chamber 100AC is comprising of a (i) stable housing 9000_A (Figure 9A), which stays on the stoma attachment 200 to protect the stoma at all times, where the stable housing includes the first opening 100a that is in communication with the stoma and a second opening which is in communication with open air through a breathable (meshed) surface (9000_A_b). The stable housing (9000_A) can further include the medical grade barrier (105 or 205) to communicate with inhaled / exhaled airflow of the stoma. In some embodiments as illustrated in Figure 9B, the airflow chamber 100AC is further comprising of a (ii) detachable housing (9000_B) that attaches or detaches to the stable piece when the patient intends to use or stop using the device and can serve as a multi-mode air valve similar to the structure of airflow chamber as depicted in Figure 4A. In some embodiments the detachable housing (9000_B) includes a first opening that attaches to the stable housing (9000_A) for example by clipping over the breathable surface (9000_A_b) where or exhaled air from the stoma passes through the stable housing (9000_A), via breathable (meshed) surface (9000_A_b) and enters the detachable housing (9000_B). The detachable housing can further include a second (900_B_b), a movable member 110 and a third opening 100AC_c similar to the embodiment depicted in Figure 4 A. In some embodiments the stable and detachable housing structure of the air cavity (Figure 9C) provides the device with maximum portability for continued use. In some embodiments the double housing airflow chamber can be used as standard HME to maximize stoma safety for continued use.

[0156] In some embodiments, voice generation system 100 can provide portability where the air outlet 100AC_c of the airflow chamber 100 AC via a detachable connection. In some embodiments, as depicted in Figure 10, air outlet 100AC_c is detachable via for example a magnetic detachable coupling to maintain portability of the device. In some embodiments, airflow chamber housing 1000_AC has a magnetic connection to the air outlet 100AC_c, where the detachable outlet tube 11010 can be attached or detached from the housing using for example a magnetic attachment / detachment. In some embodiments, the airflow chamber magnetic detachable air outlet 100AC_c enables the voice chamber 100VC and other parts of the device to be removed and placed in a carry box when not needed for voice generation to maximize the portability. In some embodiments the airflow chamber, when its air outlet 100AC_c is detached can remain connected to the medical grade respiration barrier 105 or 205 and in communication with the stoma attachment to be used as a standard HME to protect the stoma.

[0157] In some embodiments, the passage of exhaled airflow inside the airflow chamber 100AC which naturally includes moisture, occasionally results to condensation built up inside the device. In some embodiments the airflow chamber 100 AC can comprise a moisture trap (also called water trap) to capture and contain condensation water droplets inside. In some embodiments, the moisture trap can reroute condensation moisture droplets that are present inside airflow chamber housing 1000_AC from traveling to the movable member 110 or towards the first opening 100a towards the stoma. In some embodiments the water trap restricts and redirects fluids including saliva travelling from air outlet 100AC_c towards the air chamber 100 AC from reaching to the stoma.

[0158] In some embodiments, as depicted in Figure 11 the water trap 100_AC_WT is part of the airflow chamber 1000_AC where in the water droplets move outside the airflow chamber 1000_AC through a one-way water trap opening 10010 which direct water droplets shaped inside the airflow chamber 100 AC to the water trap in the direction of gravity to enter the water trap. In some embodiments as depicted in Figure 11, the water trap includes a water reservoir 10030 where water droplets are added to be removed when needed. In some embodiments as depicted in Figure 11, the water trap includes a water outlet valve 10020 that comprises a movable rubber that valve opens to let the droplets outside the device. In some embodiments, the water outlet valve 10020 made of flexible rubber that can be opened, wherein the fluid collected in the moisture trap can be released and the moisture trap reused. In some embodiments, as depicted in Figure 11 the water trap 100_AC_WT is connected and part of the airflow chamber air outlet 100AC_c where the air existing the air outlet 100AC_cassists removing the water droplets outside the device to the water trap. In some embodiments, the moisture trap has a touch sensor, or a mechanical outlet 10020 connected to a spring to release the moisture out of the device.

[0159] In some embodiments, the airflow chamber as disclosed herein can comprise a humidity detector or sensor. In some embodiments, the humidity detector is in communication with the airflow chamber 100AC. In some embodiments, the humidity detector can alert the subject of potential moisture, condensation, saliva or water droplets presence in the airflow chamber, wherein the humidity detector alerts the subject when detecting moisture. In some embodiments, alerting of the humidity detector comprises, for example, a visual indictor such as changing the color of a section of the airflow chamber, an indicator lighting, or an auditory signal. In some embodiments, the moisture trap has a touch, mechanical or electronics mechanical outlet connected to a spring to release the moisture out when the moisture sensor alerts the user of the humidity built up inside the device.Airflow duct

[0160] Voice generation system 100 further comprises and defines an air passage, air channel, or airflow duct 133 as described in the general embodiments of Figures 2A-2C. Referring to Figure 12A and 12B, in some embodiments, the airflow chamber 100 AC is in communication with an airflow duct 133. In some embodiments, the airflow duct 133 as disclosed herein includes a first opening 1331 and a second opening 1332. In some embodiments, the first opening of the airflow duct 133 is in communication with the third opening of the airflow chamber 100AC_c (air outlet). In some embodiments, the second opening of the airflow duct 1332 is in communication with the voicebox chamber 100VC. In some embodiments the airflow duct 133 is an airflow tube (a.k.a., flow tube).

[0161] In some embodiments, the flow tube 133 comprises a flexible tube. In some embodiments, the flow tube is made of a more rigid tube. In some embodiments, the flow tube comprises a medical grade biocompatible tube. In some embodiments, the flow tube is disposable to maximize the device hygiene. In some embodiments, the flow tube is disposable for daily use too or longer periods of time to maximize the device hygiene. In some embodiments, the flow tube length is adjustable and can be elongated to match different subject’s neck length.

[0162] In some embodiments, as depicted in flow tube 133 is attachable or detachable to the airflow chamber or voice chamber to maximize portability of the device. In some embodiments, as depicted in flow tube 133 is attachable or detachable to the airflow chamberor voice chamber to maximize safety of the device where the airflow chamber 100AC and the medical grade barrier 105 or 205 stay on the stoma and the flow tube 133 and voice chamber 100VC can be carried in a portable case to be used when needed. In some embodiments, as depicted in flow tube 133 is attachable or detachable to the airflow chamber or voice chamber via mechanical coupling. In some embodiments, as depicted in flow tube 133 is attachable or detachable to the airflow chamber or voice chamber via magnetic coupling where the tube openings 1331, 1332 have for example magnetic rings embedded that connect or disconnect to the openings in airflow chamber and voice chamber.

[0163] In some embodiments as depicted in Figure 13, the flow tube 133 is designed to provide the device with handsfree function and eliminate the user’s need to hold the device manually. In some embodiments, the flow tube 133 is a flexible tube that resumes its position with a spring or wireframe embedded around or inside flow tube wall to bounce back in position enabling hands-free use of the device. In some embodiments, the flow tube 133 is a more rigid tube made of rigid medical grade silicone with durometer of for example Shore A 50 or more that maintains its shape to keep the voice source in position for hands-free use of the device. In some embodiments, the flow tube 133 is a flexible tube with a bending radius of more than 90 degrees to avoid the tube blocking the airflow.

[0164] In some embodiments, the passage of exhaled airflow through the flow tube which naturally includes moisture occasionally results in condensation inside the tube. In some embodiments, the penetration of saliva droplets from the voice chamber 100VC towards the flow tube results in saliva water droplets leaking inside the tube. In some embodiments, the flow tube 133 walls can have a movable window that rotates around the tube axis to allow exhaled air to outside the window and reduce the condensation effect. In some embodiments the flow tube has a water trap that captures and holds condensation droplets not to reach the airflow chamber. In some embodiments, the internal surface of the flow tube can be modified (for example with embedded micro-grooves in the tube internal walls) to route condensation or saliva droplets inside the tube towards a water trap in the flow tube. In some embodiments the flow tube water trap can be implemented for example using a double layered tube with a porous boundary or micro holes (such as with 0.5-1 mm diameter) between the two layers where the air passes through the internal tube and condensation droplets built on the internal wall penetrate micro holes that are trapped in the external layer.

[0165] In some embodiments the airflow duct 133 or other parts of the device can be made of selective, semi-permeable material that transfers water vapor, condensation or built up moisture to the environment, thereby reduce or prevent the condensation while they maykeep the air from escaping from the device. In some embodiments the flow tube 133 is made of highly selective, semi -permeable material that passes the moisture built inside the tube to be transferred outside the tube walls while keeping the air inside. In some embodiments, these selective materials may provide for such semi-permeability based on difference of vapor pressure inside and outside the device.

[0166] In some embodiments, the internal surface of the flow tube 133 can be covered with a moisture repellent material. In some embodiments, the moisture repellent material can prevent condensation or saliva to shape droplets inside the tube. In some embodiments, the moisture repellent material can comprise a hydrophobic or superhydrophobic coating. In some embodiments, the hydrophobic or superhydrophobic coating comprises coatings such as Aqualene® 5000: Hi-Performance OGR Coating. In some embodiments, the moisture repellent comprises a bio-safe or biocompatible hydrophobic polymer.

[0167] In some embodiments, the flow tube 133 can have a condensation wipe mechanism for example using a moving magnetic ring attached to the surface of inner flow tube 133 walls coupled to a moving magnetic ring outside the tube where the outside and inside rings magnetically couple to each other and moving the outside ring moves the inside ring to wipe down the condensed moisture from inside of the flow tube towards the moisture trap.

[0168] Condensation inside the flow tube is more frequent in cold or more humid weather as the result of moisture built inside the tube condensing to water, in some embodiments, the flow tube 133 can be thermally isolated to prevent exhaled moisture to condense inside the tube to water droplets. In some embodiments, thermal isolation in the flow tube involves a for example the use of heat-generating copper coils implemented inside the flow tube wall. In some embodiments, heat-generating copper coils integrate a battery powered current source. This source generates an electric current that flows through the heat-generating copper coils, keeping the tube walls thermally isolated from the cold weather to prevent condensation. In some embodiments thermal isolation may be initiated by the user using a manual electronic switch.

[0169] In some embodiments, the flow tube may incorporate a temperature sensor and a battery. The temperature sensor serves to monitor the temperature inside the flow tube or the surrounding environment. When the sensor detects low external temperatures leading to condensation, it activates the battery powered current source to initiate the heat generation process. The battery powered current source in certain instances may comprise a standard battery, or in other cases, a rechargeable battery.

[0170] In some embodiments, the flow tube 133 can be thermally insulated using externalcoatings. This insulation often involves a foam insulation or a polymer covering. In such cases, the external surface of the flow tube is enveloped by foam insulation, and this assembly is further protected by the polymer covering. The specific materials used in the foam insulation and polymer covering can vary. In some instances, the foam insulation may comprise a polymer covering comprising medical grade polystyrene or polyurethane foam.Voicebox chamber

[0171] In some embodiments, the invention can comprise a voicebox chamber 100VC as described in the general embodiments of Figures 2A-2C. In some embodiments, the invention can comprise a voicebox chamber 100VC that converts exhaled airflow to a voice (sound waveform) which can be used by a person with lost or damaged larynx to speak with. In some embodiments, the invention can comprise a voicebox chamber where the voicebox chamber converts respiration airflow to an exceptionally high-quality voice. In some embodiments, the voicebox chamber generates a sound that is modulated by mouth movements of a person with lost or damaged larynx to generate an exceptionally high-quality speech signal.

[0172] In some embodiments, as depicted in Figure 14, the voicebox chamber 100VC as disclosed herein can comprise a housing 1000VC with a first opening 100VC_a and a second opening 100c where the first opening 100VC_a is in communication with flow tube 133 and receives exhaled airflow of the stoma exiting from the flow tube. In some embodiments, the voicebox chamber housing 100VC has a second opening (open-end voice outlet) 100c which is in communication with the oral cavity of the user. In some embodiments, the voicebox chamber housing 100VC has a second opening (open-end voice outlet) 100c which is in communication with the human mouth via an oral adaptor lOOd. In some embodiments respiration or air enters the first opening 100VC_a of the voice chamber 100VC and the resulting voice and the exhaled airflow exist the second opening 100c to the oral adaptor lOOd to reach the user’s mouth, where the voice and airflow excite the vocal tract for the patient to generate speech. In some embodiments the voicebox chamber 100VC can have more than two openings. In some embodiments the voicebox chamber 100VC is a disposable unit.

[0173] In some embodiments, as described in the general embodiments of Figures 2A-2C, the voicebox chamber 100VC can comprise a movable voice member 120. In some embodiments, the movable voice member 120 can reside within the voicebox chamber. In some embodiments, as descried inn Figure 14, the movable voice member can generate asound in response to respiration air that passes through the voicebox chamber from the first opening 100VC_a whereby the sound exits the voicebox chamber through the second opening 100c. In some embodiments, the movable voice member 120 voice generation can be driven by expiration to generate a high-quality voice.

[0174] In some embodiments voice generation system and method 100, uses the function of the movable air member 110 and movable voice member 120 to automatically control voice onset and offset and generate an exceptionally high-quality voice using a patient’s respiration. In some embodiments voice generation system and method 100, uses the interaction of movable air member 110 and movable voice member 120 to automatically control onset and offset of the voice and voiced / unvoiced transitions in speech.

[0175] In some embodiments as depicted in Figure 2A-2C, at the onset of the voice, exhaled airflow exists from the stoma to enter the airflow chamber where the movable air member is engaged to direct the airflow through the flow tube 133 to reach to the voice chamber 100VC. This air flow can vibrate the movable voice member 120 and generate voice. In some embodiments at the instance of voice offset, the exhaled airflow is reduced and movable air member 110 returns to its default position to direct the exhaled airflow to the open-end air inlet / outlet 100b which disables airflow to reach the voice chamber and movable voice member 120 and stops voice generation. In some embodiments movable air member 110 is responsible to control automated voice onset and offset control where the movable voice member 120 is responsible in generating voice from respiration. In some embodiments the interaction of movable air member 110 and movable voice member 120 affects automated voice onset and offset control.

[0176] In some example embodiments, the movable member 120 can comprise medical grade silicone. In some embodiments, the voice membrane 120 can comprise natural or synthetic rubber or metal or thin films of other vibrating material. In some examples, the voice movable member can comprise double layered sandwiched thin hollow silicone films filled with a gel material such as PEG (polyethylene glycol) hydrogel widely used to simulate vocal folds in vitro or fluidic injection between the two layers in whole or in specific parts to simulate the fluidic based structure of human vocal folds. In some embodiments, the movable member can comprise silicone sheets with printed or extruded patterns on the surface of the sheet to simulate the irregular structure of vocal folds vibrations.

[0177] In some embodiments, the movable voice member 120 as disclosed herein can comprise a voice membrane 120. In some embodiments, the voice membrane 110 as disclosed herein can be placed inside the voice chamber 100C and close to the secondopening 100c and engaging to the direction of air passing through the voice chamber 100VC. In some embodiments, the voice membrane can vibrate in response to airflow passing through the voice chamber and exiting the second opening 100c to generate a voice. In some embodiments the voice membrane can be placed in or removed from the voice chamber 100C easily without disturbing other parts of the device and it is disposable.

[0178] In some embodiments, the voice membrane is made of a flexible thin sheet of for example natural or synthetic rubber or silicone (for example with thickness of 0.1 to 0.5 mm), which is flexible (for example with flexibility durometer of Shore A 20-50) to vibrate in response to human exhaled airflow. In some embodiments, the voice membrane is made of a flexible thin sheet of for example natural or synthetic rubber, or silicone which has a natural resonance frequency which is in the range of human voice fundamental frequency range (which can vary from 70 to over 300 Hz). In some embodiments, the voice membrane can be customized with a range of thickness and flexibility, to create sound for people different respiratory power levels. In some embodiments, the voice membrane 120 can be quantized in parameters such as flexibility or thickness to create sound for people different respiratory power levels. Additionally, the voice membrane can be quantized to accommodate subjects with low, moderate, or high airflow power. In some embodiments, voice membrane can be quantized in parameters such as flexibility or thickness so that the vibration onset of voice matches the user respiration effort for voice generation onset to correlate with users’ minimal respiration effort closer to the tidal breathing to avoid long term fatigue.

[0179] Figure 15 shows one preferred embodiment of the voice generation system 100. In some embodiments, at the onset of the voice, exhaled airflow exists from the stoma to reach first opening of the airflow chamber 100a where the air membrane 110 closes the second opening 100b to direct the airflow to third opening 100_AC_c to the flow tube. The air passing the flow tube 133 reaches the voice chamber 100VC and can vibrate voice membrane 120 to generate voice. In some embodiments at the instance of voice offset, the exhaled airflow is reduced and the air membrane 110 returns to its default position to direct the exhaled airflow to the open-end air outlet 100b which disables stoma exhaled airflow to reach 100_AC_c and the voice chamber 100VC and movable voice member 120 and stops voice generation. In some embodiments the air membrane 110 is heavier than the voice membrane 120 so when exhaled airflow is strong to move the air membrane, it also vibrates the and hence the air membrane 110 affects the onset of the voice. In some the air membrane 110 is lighter than the voice membrane and the latter affects the onset of the voice. In some the air membrane 110 is heavier than the voice membrane and the former affects the onset of thevoice. In some embodiments the interaction of the air membrane 110 and movable voice membrane 120 affects automated voice onset and offset control.

[0180] In some embodiments, the voice chamber 100VC can comprise a membrane holder 120VC. In some embodiments, the membrane holder 120VC secures the voice membrane 120 inside the voicebox chamber and can be repositioned, attached or detached in and out the third opening 100VC_c to remove, reposition to replace the membrane. In some embodiments the membrane holder is disposable. In some embodiments the membrane and membrane holder are two separate parts with the membrane to be detachable and disposable if needed. In some embodiments the membrane and membrane holder are a single disposable unit.

[0181] In some embodiments, as depicted in Figure 16 A, the voicebox chamber 100VC is comprised of a housing 1000VC with a first opening (air inlet) 100VC_a which is in communication with the flow tube and a second opening (open-end voice outlet) 100c which is in communication with the human mouth via an oral adaptor lOOd and a third opening 100VC_c which provides easy access to the membrane holder 120VC. In some embodiments as exemplified by Figure 16B, the air enters voice chamber housing 1000VC via the internal air inlet 1001 VC which is in communication with the first opening 100VC_a and exits the internal voice / air outlet aperture 1002VC which is in communication with the voice chamber second opening 100c. In some embodiments, the membrane holder is placed inside the voice chamber 100VC to place the membrane perpendicular to the direction of airflow passing thorough the voice chamber from the internal air inlet 1001 VC and internal the voice / air outlet 1002VC.

[0182] In some embodiments as described in Figure 16C, the voice membrane 120 is comprised of a thin disc shape film 1200, silicone or natural or synthetic rubber with a rectangular or curved segment 1201 in the middle whereby the disc or the middle part can be flexible to vibrate in response to respiration and generate a high-quality voice. In some embodiments the as described in Figure 17A Voice membrane 120 is placed in a resting position (with the disc shape 1200 secured in or around the membrane holder 120VC with the center part 1201 to be free to vibrate) for easy replacement. In some embodiments the disc shape 1200 is part of the membrane, in some embodiments the disc shape is made of a rigid material such as plastic which holds the center part membrane is place for easier assembly and replacement in the membrane holder.

[0183] In some embodiments, as depicted in Figure 17 A, the membrane is placed inside the membrane holder in a resting position with minimal pneumatic resistance where a minimumrespiration force can set the membrane to vibrate. In some embodiments, as depicted in Figure 17B, the membrane holder places the membrane inside the voice chamber cavity 1000VC and close to the internal voice / air outlet aperture 1002VC which is in communication with the second opening of the voice chamber 100c. In some example embodiments as depicted in Figure 17B the membrane holder places the membrane inside the voice chamber perpendicular to the direction for air passing inside the voice chamber housing 1000VC to exit from the internal voice / air outlet aperture 1002VC. In some embodiments exhaled air passing through the voice chamber exits from the small distance between the membrane 120 and the internal voice / air outlet aperture 1002VC, which easily vibrates the voice membrane 120. In some embodiments the membrane holder 120VC can change the position of the membrane be closer or farther from the internal voice / air outlet aperture 1002VC for the membrane to vibrate in response to lower or higher airflow, making the device adaptive and comfortable for use for people with smaller or larger lung capacities.

[0184] In some embodiments the voicebox chamber 100VC and the membrane holder 120VC is designed to acoustically amplify or attenuate specific parts of the spectrum of the generated sound to improve the clarity of the voice. In some embodiments the voicebox chamber or membrane holder includes an acoustic resonance chamber surrounding the membrane where the generated sound is acoustically amplified. The voicebox chamber housing 1000VC for example can have adjustable depths for the user to customize the amount of acoustic amplification.

[0185] In some embodiments, the membrane holder can adjust the position the voice membrane inside the voicebox chamber with respect to the voice / air outlet aperture 1002VC. In some embodiments, the position of membrane holder can be adjusted by the user with respect to the voice / air outlet aperture 1002VC. In some embodiments, the position of membrane holder can be adjusted by the user with respect to the second opening so that the onset of voice occurs with minimal respiration efforts closer to the tidal breathing to avoid long term fatigue. In some embodiments, the membrane holder can have a thread (such as 1202VC in Figure 17A) to move inside the voicebox chamber housing 1000VC for the user to adjust the position of the membrane to match the expiration output of the patient. In some embodiments, the position of the membrane holder can be adjusted an automatically (using a voice coil actuator or stepper motor driven by a pressure sensor placed inside the voicebox chamber) to match the expiration output of the patient. In some embodiments, the position of the membrane holder can be adjusted using a Bluetooth® remote control system, a voice coil actuator, or a miniature step motor. Additionally, the voice membrane’s position mayneed to change over time as the membrane softens due to extended use or exposure to respiratory heat and moisture.

[0186] In some embodiments, the voicebox chamber housing can act as a minimum resistance passage for the air to enable the device 100 voice generation to be driven by minimal respiratory effort where respiratory effort can be measured by spirometry. In some embodiments, the minimal respiratory effort would require for the device to generate voice at air flow levels close to maximum tidal beathing for a patient. In some embodiments, the minimal respiratory effort provides the patient to generate voice easier and minimize patient fatigue for long term use of the device.

[0187] In some embodiments, the voice membrane 120 can be configured to minimize the respiration effort needed for the onset of the voice where the respiration effort (tidal respiration pressure measured in in kPa and peak airflow measured in liters per minute) can be measured with spirometry. In some embodiments, the air membrane can be configured to minimize the respiration effort needed for the onset of the voice where the respiration effort (peak airflow measured in liters per minute) can be measured with spirometry. In some embodiments, the respiration effort needed for the onset of the voice is set to be slightly higher than maximum tidal breasting or any number from 1.01 to 2 times the average tidal breathing effort for a subject to minimize patient fatigue for continuous use. In some embodiments, the respiration effort needed for the onset of the voice can be slightly higher than average tidal breasting for a subject to minimize patient fatigue for continuous use.

[0188] In some embodiments, the membrane holder can be configured to minimize the respiration effort needed for the onset of the voice by maintaining a minimum resistance passage for the air to enable voice membrane 120 vibrations to be driven by minimal respiratory effort where respiratory effort can be measured by spirometry. As depicted in Figure 16B, in some embodiments the membrane holder 120VC receives the airflow from the air inlet 1001 VC of the voice chamber and passes that air to the voice / air outlet 1002 VC. As depicted in Figure 17B, in some embodiments the membrane holder 120VC includes a mesh structure 1203VC to apply to the air passing through the membrane holder to convert potential jet airflows to laminar streams of air suitable to generate a steady force to vibrate the membrane 120 at lower air flow values. The increased sum of the surface area of the mesh structure 1203VC adds to the surface area of air passage through the device and minimizes air resistance inside the device. In some embodiments as depicted in Figure 17B, the membrane holder can for example have a cylindrical shape with an open end and a closed end, where the mesh structure 1203VC is implemented on the cylinder walls. In someembodiments the surface area of the mesh structure can be increased or decreased, for example manually by the user where the membrane holder has two sliding cylinders with mesh structures to slide in close contact with each other. This provides the device with adjustable mesh size and hence adjustable airflow resistance for the device to work comfortably for people with a wide range of lung capacities. In some embodiments the surface area of the mesh structure 1203VC can be quantized from small to large to provide the device with the flexibility to function for people with a large range of respiration power.

[0189] In some embodiments the voice chamber 100VC and or the voice membrane can 120VC be specifically designed to stop, decrease or eliminate voice membrane 120 from jamming. Membrane jamming is a condition where higher lung volumes or excessive amount of airflow, pushes the voice membrane to close the voice / air outlet aperture 1002VC resulting unfavorable stopping of the vibrations of the voice membrane 120. In some embodiments the voice membrane can be adjusted to have a thicker depth or heavier weight for the device to reduce the jamming effect and work comfortably for people with higher respiration efforts, where the respiration effort can be measured via spirometry.

[0190] In some embodiments the voice chamber 100VC and or the membrane holder 120VC can be specifically designed to stop, decrease or eliminate voice membrane 120 from jamming. In some embodiments the voice chamber 100VC can have a fourth outlet which acts an exhaust for excessive air to escape the chamber and reduce the jamming effect. The exhaust is a one-way air valve that has a higher acoustic resistance compared to the voice / air outlet aperture 1002 VC. The air naturally exits the voice / air outlet aperture 1002 VC when the voice membrane is silent or vibrating, however, with jamming and closure of voice / air outlet aperture 1002VC, the pressure built inside the voice chamber housing 1000VC activates the exhaust path and the air escapes this opening, enabling the voice membrane 120 to resume from jamming to its vibrating position. This may be monitored using a differential pressure sensor where the respiratory pressure inside the voice chamber jumps to a local maximum at prior or the incidence of the voice membrane jamming. In some embodiments the jamming exhaust can be implemented in other parts of the device including the flow tube or voice chamber surface. In some embodiments the jamming exhaust can be manually activated by the user for example using a touch sensor placed on the voicebox chamber 100VC surface or airflow chamber 100AC.

[0191] In some embodiments, the voicebox chamber and the membrane holder as disclosed herein can comprise a jamming detection pressure or flow sensor. In some embodiments the pressure inside the voicebox chamber jumps and the airflow stops when or prior to thejamming event. In these embodiments the jamming detector is operably connected to the voicebox chamber. In some embodiments the voicebox chamber has a pressure activated or electronically activated exhaust mechanism to expel additional air to prevent membrane jamming. In some embodiments the voice membrane placement can be adjusted with respect to the second opening based on the input from the jamming sensor to increase or decrease the distance between the membrane and second opening to avoid membrane jamming.

[0192] In some embodiments, the membrane holder adjusts the position of the membrane inside the voice chamber, effectively influencing and reducing the jamming. In some embodiments the membrane holder performs this adjustment using a thread (such as 1202VC in Figure 17A). In some embodiments the thread structure can be designed to include a leaky thread where the thread is designed coarse or with intended gaps to result air leak from the chamber. In some embodiments the leaky thread 1202VC acts as an exhaust mechanism for excessive pressure built inside the chamber to release and to avoid jamming. In some embodiments the membrane holder thread 1202VC can be implemented in quantized steps to control the amount of the leak for example spanning the thread from coarse to fine to minimize the air leak, where the minimal air leak would be better to be used with patients with smaller lungs or respiration power, effectively making the device adjustable to work with minimal jamming for people with different ranges of respiration powers, were respiration power of the user is measured using spirometry.

[0193] In some embodiments, the voicebox chamber as disclosed herein can comprise a humidity detector or sensor. In some embodiments, a humidity detector can alert the subject of potential saliva / fluid leakage to the voicebox chamber, wherein upon detection of moisture, the humidity detector alerts the subject for example with a visual or an auditory indicator about the humidity built up inside the device. In some embodiments the voice chamber 100VC includes an additional water trap to remove saliva or condensation from the device.Oral adapter

[0194] The voicebox chamber 100VC can further comprise an oral adapter lOOd. In some embodiments, as depicted in Figure 14, the oral adaptor can have an inlet lOOdl which is in communication with the second opening of the voicebox chamber (open end voice outlet) 100c. In some embodiments the oral adapter lOOd is an elongated extinction of the open-end voice outlet 100c. In some embodiments the oral adapter lOOd is a separate attachment to the open-end voice outlet 100c

[0195] In some embodiments, the oral adaptor has an outlet 100d2 where the outlet 100d2 is in communication with the oral cavity of the user and that can transfer the airflow and sound from the voicebox chamber into the oral cavity of the subject. In some embodiments, the oral adaptor acoustically amplifies the voice. In some embodiments, the oral adaptor is an oral tube.

[0196] In some embodiments, the oral tube lOOd comprises a flexible tube to be placed comfortably inside the mouth. In some embodiments, the oral tube comprises a rigid tube. In some embodiments, the oral tube outlet has a mesh structure that disperses the airflow in different directions to avoid the oral tube outlet 100d2 to be blocked by the tongue movements. In some embodiments, the oral tube outlet 100d2 is made of a deformable material such as a flexible silicone ring to change shape provide air escape from the outlet when the tongue or vocal tract movements may strict or block the oral tube outlet 100d2. In some embodiments the oral tube lOOd is adjustable in length or diameter to match respiration power of different people. In some embodiments the oral adapter lOOd is a disposable unit.

[0197] In some embodiments the oral tube has an oral tip or saliva trap to restrict or prevent saliva penetration to the device. In some embodiments, the oral tube outlet has a mesh structure to limit saliva penetration to the tube. In some embodiments the oral tube lOOd has similar hydrophobic coating of the flow tube 133 to avoid saliva droplets or condensation blocking the tube. In some embodiments the oral tube lOOd has an aperture than can be opened manually or electronically to let the saliva or moisture out.

[0198] In some embodiments the oral tube diameter can be 0.5-8 mm or more internally. In some embodiments the oral tube diameter can be adjusted by the user for increased / decreased respiration resistance. In some embodiments the length and diameter of the oral tube can be adjusted to increase or decrease the respiration resistance of the device to work for people with different respiration powers.

[0199] In some embodiments the oral tube lOOd can have a microphone to pick up the generated speech closer to the mouth and pass that to a Bluetooth® or wired speaker implemented on the device or separately to amplify or enhance the resulting speech in noisy environments.Voice quality

[0200] In some embodiments the movable voice member 120 can be designed to generate a sound of exceptionally high-quality within natural human voice fundamental frequency range. In some embodiments, the movable voice member or the voice chamber can beconfigured to adjust the parameters of generated voice to customize the voice for the subject such as for example the voice fundamental frequency to relate to male, female or non-binary fundamental frequency range.

[0201] In some embodiments, the voice membrane 120 can be configured to generate a singing sound associated with a fundamental frequency range of a singing voice type. In some embodiments, the voice membrane can be configured to generate a voice associated with a singing voice type, including but not limited to baritone, mezzo-soprano, soprano, alto, bass, tenor, contralto, or similar.

[0202] In some embodiments, the voice membrane can be configured to generate sound associated with a tonal or non-tonal language. In some embodiments, the voice membrane can be configured for example to generate sound associated with Chinese tonal language. In some embodiments, the voice membrane can be configured to generate respiration driven intonation variations inside the phoneme suitable to generate Chinese tonal language. In some embodiments, the voice membrane can be configured to generate a sound of a selected voice quality. In some embodiments, the voice membrane can be configured to generate singing sound of a selected voice quality.

[0203] In some embodiments the membrane holder 120 VC can be designed to modify the voice membrane 120 shape such as to stretch the membrane or lift or press the membrane at certain areas to increase or decrease the length of the vibrating membrane to modify parameters of voice generation. In some example embodiments, the membrane holder can be configured to adjust the length or width of the voice membrane 120 so that the resulting voice parameters (such the fundamental frequency) are adjustable by the user. As illustrated in Figure 18A, in some example embodiments, the membrane holder 120VC can be configured to have some edges 1204 VC that lift the membrane and decrease the length (or width) of the vibrating segment of the voice membrane to increase the fundamental frequency of the resulting voice for the voice to sound more female. In some embodiments, the membrane holder can be configured to increase the length (or width) of the voice membrane to decrease the fundamental frequency of the resulting voice for the voice to sound more male. In some embodiments, the membrane holder can be provided in predesigned shapes that are quantized with different shapes and lengths of the membrane for the device to be customizable for people who need different voice parameters. For example, Figure 18B shows an example membrane holder where the membrane holder does not change the fundamental frequency of the voice membrane vibration. Figure 18A shows an example of a female sounding membrane holder. In some embodiments the membrane holder can beconfigured to modify the membrane shape mechanically or electronically driven by a touch sensor (such as to stretch the membrane or lift or press the membrane at some points to increase or decrease the length of the membrane) to generate a sound of exceptionally high- quality male or female voice. In some embodiments the membrane holder can be configured to modify the fundamental frequency of the voice with other mechanical design features.

[0204] In some embodiments the shape and material composition of the voice membrane is specifically designed for generating an exceptionally high-quality voice. In some embodiments the shape and material composition of the voice membrane is specifically designed for generating an exceptionally high-quality voice.

[0205] In some embodiments of this invention, the voice generating membrane generates a flat or close to flat frequency spectrum (with harmonic peaks amplitudes varying from + / -2 dB to + / -3 dB to + / -4 dB to + / -5 dB to + / -6 dB spanning from the frequency range of 70 Hz up to 200 Hz, 70 Hz up to 300 Hz, 70 Hz up to 400 Hz, 70 Hz up to 500 Hz, 70 Hz up to 600 Hz, 70 Hz up to 700 Hz, 70 Hz up to 800 Hz, 70 Hz up to 900 Hz, 70 Hz up to 1000 Hz or 70 Hz up to any value between 300 Hz to 2500 Hz (as for example depicted in Figure 19). The frequency spectrum of the source can be measured in an anechoic chamber using a flat frequency spectrum microphone such as Bruel & Kjaer Type 4192 which has a pressure field response of 5 Hz to 7 Khz + / -1 dB (3 Hz to 20 kHz) + / -3 dB and is reliable to measure the source spectrum. In these measurements the voice chamber can be driven by the airflow of the stoma or a simulated air flow of the neck stoma (such as generated by a real-time silent ultrasonic air pump replicating a pre-recorded respiratory pressure or airflow of the stoma), where the microphone is placed at a distance of 30-50 cm from the source in the anechoic chamber.

[0206] In some embodiments the shape and material composition of the voice membrane is specifically designed for generating an exceptionally high-quality voice with wide peaks and narrow valleys in the harmonic frequency spectrum in the frequency range of 70 Hz up to 200 Hz, 70 Hz up to 300 Hz, 70 Hz up to 400 Hz, 70 Hz up to 500 Hz, 70 Hz up to 600 Hz, 70 Hz up to 700 Hz, 70 Hz up to 800 Hz, 70 Hz up to 900 Hz, 70 Hz up to 1000 Hz or 70 Hz up to any value between 300 Hz to 2500 Hz (as for example depicted in Figure 19).

[0207] In some embodiments the a wide peak in the harmonic frequency spectrum of an exceptionally high quality voice can be defined where the majority of the energy of the peak (calculated in the frequency spectrum or power spectral density as the integral of spectral spectrum amplitudes or power spectral density values around the peak across the peak bandwidth) is distributed across more than 20%, across more than 30%, or across more than40% of the peak bandwidth where the peak bandwidth is the difference of the frequency values associated with the two valleys before and after the peak (as for example depicted in Figure 19).In some embodiments the flat or semi-flat harmonic structure of the generated voice and inclusion of wide peaks in the spectrum majorly improves the excitation of vocal tract formants with the resulting voice, providing clear vowels and consonants in speech. In some embodiments the flat or semi-flat harmonic structure of the generated voice with wide spectrums generates an exceptionally high-quality close to or natural sounding voice. In some embodiments the spectral peaks of the frequency spectrum of the voice membrane (as for example depicted in Figure 19) translates to a waveform close to the natural glottal voice waveform in time domain.

[0208] In some embodiments the material composition of the voice membrane is specifically designed for generating an exceptionally high-quality voice for example where the Voice membrane 120 is comprised of thin silicone films of flexibility (measured by Shore A) varies between 20-50 and shape (width) of the voice membrane varies from 6-15 mm. In some embodiments the membrane thickness varies from 0.1 to 0.6 mm.

[0209] In some embodiments the shape of the voice membrane is specifically designed for generating an exceptionally high-quality voice. In some embodiments, the voice membrane is made of a flexible thin sheet of for example natural or synthetic rubber, or silicone which has a natural resonance frequency in the range of human voice fundamental frequency range (which can vary from 70 Hz to over 300 Hz). In some embodiments, the voice membrane is made of a flexible thin sheet of for example natural or synthetic rubber, or silicone which is flexible (for example with thickness anywhere in the range of 0.05 to 0.6 mm). In some embodiments, as depicted in Figure 16C, the voice membrane 120 can be cut in different shapes including for example a circular disc frame 1200 connected to a rectangular circular or oval or irregular shapes 1201 to generate the irregularities of natural voice vibrations. In some embodiments as depicted by Figure 17 A, the voice membrane is a thin circular disc frame with adjustable sizes that can be attached or detached to the placeholder slice 1201VC of the membrane holder 120 VC. In some embodiments the vibrating element of the membrane 1201 can for example be about 4 to 16 mm in width. In some embodiments the vibrating element of the membrane 1201 can be, for example, 6 to 20 mm in length. In some embodiments the vibrating element of the membrane 1201 can for example have a flexibility durometer Shore A of 10 to 50 to vibrate easily in response to human exhaled airflow. In some embodiments as depicted in Figure 16C, the voice membrane includes a circular disc1200 where the vibrating element 1201 of the membrane can for example have in a rectangular shape 1201 of for example 5 to 16 mm by 6 to 20 mm and durometer Shore A 20-50) to generate an exceptionally high-quality human voice. In some embodiments the vibrating element 1201 of the membrane can have other shapes.

[0210] In some embodiments, the voice membrane can be configured to generate a sound with an intended fundamental frequency (pitch). In some embodiments, the voice membrane can be configured to generate a sound with a pitch of a specific frequency. In some embodiments changing the fundamental frequency of the spectrum of the example voice membrane in Figure 19 provides the sound source with an exceptionally high-quality natural sounding voice with the possibility of generating male, female or non-binary voice. In some embodiments the material, flexibility (measured by Shore A), thickness or shape of the voice membrane 120 can be adjusted for the fundamental frequency of the harmonic spectrum of the source to span from male (70-150 Hz) to non-binary (130-160 Hz) to female (160-240 Hz) and higher values for children. In some embodiments, the voice membrane can be configured to generate a sound with a pitch with a frequency of about 60 Hz to any value less than 350 Hz. In some embodiments, the voice membrane can be configured to generate a sound with a pitch with a frequency of at least or about 60 Hz to of at least or about 350 Hz. In some embodiments, the voice membrane can be configured in a quantized steps to generate a sound with a pitch, wherein the pitch generate is on a quantized frequency scale.

[0211] In some embodiments, the vibrating part of the voice membrane 1201 can be cut in different shapes to modify the pitch or spectrum of the voice. For example, the length of the vibrating segment 1201 in Figure 16C can be decreased from 20 mm to 6 mm to increase the fundamental frequency from a male sounding pitch of around 70 Hz towards a female voice with over 160 Hz pitch. The other parameter to change can be for example expanding or decreasing the width of the spectral peaks in the harmonic spectrum of the generated voice in Figure 19. For example, the width of the vibrating segment 1201 in Figure 16C can be increased from 5 mm to 12 mm or more to provide wider peaks in the frequency spectrum of the resulting voice which translates to improved excitation of the vocal tract and improved formant shaping resulting improved intelligibility and clarity of the voice. In some embodiments the edges of voice membrane can be cut with curved edges or specific irregularities as example in Figure 16C for the resulting sound to generate natural irregular vibrations of human vocal folds. In some embodiments the external disc 1200 can have a radius of for example 10 to 40 mm and the width of 0.1 to 10 mm to enhance the harmonic structure of the voice spectrum. In some embodiments the external disc 1200 can have aradius of for example 10 to 40 mm and the width of 0.1 to 10 mm to adapt to the respiration effort of different users. In some embodiments the edges of the external disc 1200 can be cut with non-straight edges such as curved edges or irregularities as example in Figure 16C for the resulting sound to generate the irregular and natural vibrations of human vocal folds.

[0212] In some embodiments the vibrating segment of the voice membrane 1201 or the edges of the external disc 1200 can be reinforced with thicker or thinner material at the center or edges to filter out or augment specific parts of the harmonic spectrum of its vibration pattern and the resulting voice. For example, providing a thinner recircle in the center of the membrane 1201 will amplify the higher frequencies of the spectrum of the sound as the membrane will vibrate in faster speed in response to similar air flow excitation providing better clarity in high formant vowels (such as [i]). In another example, providing irregular edges for the membrane enables the membrane to start vibration in lower airflows, reducing the voice onset and respiration effort of the device when needed.

[0213] In some embodiments the voice membrane 120 can be made of flexible silicone or natural or synthetic rubber where the size and flexibility of the membrane is specifically selected such as flexibility (measured by Shore A) to vary anywhere between Shore A 10 to 50 so that the membrane can respond to onset and offset of the voice in response to variations of respiration with less than 5 milliseconds. This minimal delay translates the source to navigate quickly between voiced and unvoiced speech, providing the patients the ability to generate intelligible speech with clear voiced and unvoiced phonemes. In some embodiments, the voice membrane can be specifically designed to generate fast vibration patterns associated with laughter sound. In some embodiments, the voice membrane can be designed specifically to convey respiratory driven pitch variations for the voice to generate emotional expressions or singing voice.

[0214] In some embodiments, the membrane holder can be configured to modify the fundamental frequency during speech or signing. In some embodiments the membrane holder can be is designed to modify the membrane shape mechanically or electronically (such as driven by a touch sensor) to stretch / de-stretch the membrane or lift or press the membrane in some points against the membrane holder for example to increase or decrease the length of the membrane) as the patient speaks or sings to generate a wider range of notes and pitch variations for speech or singing voice.Voice generation device and method

[0215] The following embodiments are provided as further preferred examples of the voicegeneration system 100. These ae examples and not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0216] Referring to example embodiments of Figures 2, 13 or 20, voice generation system 100 as disclosed in this invention includes can be used as an artificial larynx for a voice-loss patient.

[0217] In some preferred embodiments, the artificial larynx can be used in a hands-free format. In some embodiments, the artificial larynx can be used in a hands-free format, wherein the artificial larynx does not require manual holding by the user. Referring to the embodiment of Figure 13, where the flow tube 133 can be made of rigid material to hold the voice generation system in place without the need of user holding the device. In some embodiments the weight of device and the flexibility of the flow tube can be adjusted for device to hold its position inside the oral cavity without any need to engaging one hand, enabling automatic bi-directional breathing / voice control and handsfree function.

[0218] In some other preferred embodiments, the artificial larynx can be used in a handsfree format, wherein the artificial larynx is worn as a headset around the ear. Referring to example embodiments of Figure 20, the voice generation system 100 can be used as an artificial larynx worn as a headset around the ear, wherein the user does not need to hold the device manually to generate voice. Referring to example embodiments of Figure 20, the airflow chamber is in communication and attached to the stoma attachment via a medical grade respiration barrier, and the voicebox chamber rests along the ear of the human subject. The oral tube lOOd is detachable or it can rest outside of the mouth of the human subject when not in use. In some embodiments including the embodiment of Figures 13 or 20B, the artificial larynx can be used in a hands-free format, in other arrangements such as where the artificial larynx is worn as a neckband behind the neck of the user.

[0219] In some embodiments, the voice generation system 100 can be partly disposable. In some embodiments, the voice generation system 100 may be designed to be fully disposable. In particular embodiments, the voice generation system 100 is fully or in parts is intended for one-time or short-term use, where the components of the voice generation system 100, as described herein, are meant to be discarded after a period of use. These different components of the voice generation system 100 can be disposed of after varying periods of use in some instances, with the usage period ranging from half an hour, up to three years.

[0220] In some embodiments, the stoma attachment or the medical grade respiration barrier of the voice generation system 100 can be disposed of each day. In some embodiments theair chamber includes a medical grade respiration barrier and can be disposed together with the medical grade respiration barrier each day. In some embodiments the air chamber is separate from the medical grade respiration barrier and can be used multiple times and disposed after a longer period where the medical grade respiration barrier can be disposed each day. In some embodiments, the membrane of the airflow chamber, the membrane of voicebox chamber, the voicebox chamber, the flow tube and the oral tube of the artificial larynx can be disposed after one or more days.

[0221] In some embodiments a method for generating voice is disclosed which involves the voice generation system 100, to contact the neck stoma where the contact involves positioning sealing the device over a user’s stoma. Similarly, in some instances, the contact involves connecting the device to a medical grade respiration barrier which is connected to the stoma attachment and inserting the oral tube into the subject’s mouth. In some other instances, when the airflow chamber includes a medical grade respiration barrier internally, the contact involves inserting the device into stoma attachment unit.

[0222] Voice generation system 100 can be comprised of parts that can be supplied on a disposable basis including the air chamber and / or the medical grade respiration barrier. The voice generation system 100 can be designed to connect and use pre-existing (off the shelf) stoma attachments (such as baseplates or larybuttons) or the off the shelf medical grade respiration barriers (such as HMEs). The voice generation system 100 can be designed to connect to specifically designed stoma attachments or medical grade respiration barriers as part of the device.

[0223] In some embodiments, a method for generating an exceptionally high-quality voice is described, which involves the subject exhaling through their stoma, passing the expiration to an airflow chamber, and then automatically directing the airflow using a movable air member into the voice chamber to generate voice from the expiration. Moreover, the movable air member is intended to be disposable and replaceable.

[0224] In some embodiments, a method for generating voice in a subject is disclosed, where the method entails producing voice in the voice chamber using a movable voice member and automatically directing the generated voice and airflow into the subject’s mouth. Moreover, the movable voice member is intended to be disposable and replaceable. Additionally, the movable voice member can be customized to create a voice with a chosen voice spectrum, or specific pitch or frequency.

[0225] In some examples, a method for generating voice is presented, where the subject exhales through their stoma, passes the expiration through an airflow chamber, redirectedusing movable air member, through a flow tube, through a movable voice member, through an oral tube lOOd into the subject’s mouth, and generates voice in the mouth from the expiration.

[0226] In certain examples, a method for generating voice is presented, where the subject exhales an expiration through their stoma, directs the expiration through a pressure-activated switch, through a flow tube, through a voice membrane, through an oral tube into the subject’s mouth, and generates voice in the mouth from the expiration.

[0227] In some embodiments, a method for generating voice is described, where the subject exhales an expiration through their stoma, passes the expiration through a pressure-activated switch, through a movable voice member into the subject’s mouth, and generates voice in the mouth from the expiration.

[0228] In certain examples, a method for generating voice is disclosed, which involves the subject exhaling an expiration through their stoma, directing the expiration through a pressure-activated switch, through a voice membrane into the subject’s mouth, and generating voice in the mouth from the expiration.

[0229] In certain examples, a method for generating voice is disclosed which has a wide range of customizable parameters such as adjustable airflow resistance, or adjustable voice parameters to provide easy and comfortable use for people with different respiration powers including for example people with small, medium, or large lung capacities.

[0230] Optional embodiments may also be said to broadly include the parts, elements, steps and / or features referred to or indicated herein, individually or in any combination of two or more of the parts, elements, steps and / or features, and wherein specific integers are mentioned which have known equivalents in the art to which the invention relates, such known equivalents are deemed to be incorporated herein as if individually set forth.

[0231] Although a preferred embodiment has been described in detail, it should be understood that many modifications, changes, substitutions or alterations will be apparent to those skilled in the art without departing from the scope of the present invention.

[0232] Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise”, “comprising”, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”.

[0233] Throughout this specification and the claims which follow, unless the context requires otherwise, the terminology of “and” “or”, in the following documents is used to include one, a subset or more or all of the options which are connected using “and”, “or” ina sentence. The terminology of “and” “or” used might be inclusive or exclusive of the options which are connected using “and”, “or”.

Claims

CLAIMS1. A respiratory driven voice generation system, comprising: a) an airflow chamber, wherein the airflow chamber comprises a first, second and third opening with the airflow chamber defining an air passage between the first, second or the third openings. wherein the first opening of the airflow chamber is configured to be in communication with, sealed against or include a medical grade respiration barrier, where the medical grade respiration barrier is in communication with a neck stoma of a user, wherein the second opening of the airflow chamber is configured to be in communication with open air, wherein the airflow chamber contains a first movable member wherein the first movable member is configured to function as a multi-directional air valve to direct air inside the airflow chamber between the first opening, second opening or the third opening; and b) a voice chamber which comprises an air inlet and a voice outlet, wherein the air inlet of the voice chamber is in communication with the third opening of the airflow chamber and the voice outlet of the voice chamber is in communication with an oral cavity of the user, wherein the voice chamber contains a second movable member that generates sound from air that exits the airflow chamber, whereby a generated voice exits the voice chamber via the voice outlet.

2. The voice generation system of claim 1 wherein the first opening of the airflow chamber is configured to include, be connected to or seal over a medical grade respiration barrier, where the medical grade respiration barrier is in communication with the stoma using a stoma attachment comprising: a substrate that can cover, attach or detach to the skin around the neck stoma of the user; and a substrate that can penetrate, at least partially inside the neck stoma of the user.

3. The voice generation system of any one of the previous claims wherein the air inlet of the voicebox chamber is in communication with the air outlet of the airflow chamber via an air duct or a flow tube.

4. The voice generation system of any one of the previous claims wherein the voice outlet of the voicebox chamber is in communication with the oral cavity of the suer via an oraladapter or an oral tube.

5. The voice generation system of any one of the previous claims wherein the first movable member provides the voice generation system with automatic transition between at least two modes of bidirectional breathing or voice generation without the need to remove the device from communicating with the neck stoma.

6. The voice generation system of any one of the previous claims, wherein the second movable member can be configured to generate a voice of an exceptionally high quality.

7. The voice generation system of any one of the previous claims, wherein the second movable member can be configured to generate a sound of selected or preset fundamental frequency (pitch) including male, female or non-binary voice quality.

8. The voice generation system of any one of the previous claims wherein the interaction of the first and second movable members provides the system with automatic inhale / exhale, automatic voice onset and offset control and automatic voice generation without the need to remove the device from communicating with the neck stoma.

9. The voice generation system of any one of the previous claims which provides a hygienic communication between the device and the neck stoma using the medical grade respiration barrier.

10. The voice generation system of any one of the previous claims where the medical grade respiration barrier comprises a Heat Moisture Exchanger (HME), which can be attachable, detachable or included in the system.

11. The voice generation system of any one of the previous claims, where the stoma attachment includes or is similar to a baseplate, larybutton or tracheostomy tube used by a laryngectomy or tracheostomy patients.

12. The voice generation system of any one of the previous claims, wherein the airflow chamber further comprises a bypass mode, which can be manually engaged by the user to enable coughing and excessive breathing without the need to remove the device from communicating with the neck stoma.

13. The voice generation system of any one of the previous claims, wherein the airflow chamber further comprises a bypass mode, using a movable window, wherein the air exits the airflow chamber through the air outlet when the window is closed. The user can open the window manually when needed to disable the air outlet without the need to remove the device from communicating with the neck stoma.

14. The voice generation system of any one of the previous claims wherein, the first movable member is a membrane that comprises silicone, natural or synthetic rubber, medical gradesilicone or other plastic or thin metal material.

15. The voice generation system of any one of the previous claims, wherein the second movable member is a membrane that comprises silicone, natural or synthetic rubber, medical grade silicone or other flexible material.

16. The voice generation system of any one of the previous claims, wherein the first membrane can be configured in pre-determined sizes that vary by mass, thickness, and flexibility for the devoice voice onset or offset to function close to the tidal respiration power of different users.

17. The voice generation system of any one of the previous claims, wherein the second membrane can be configured to generate a sound with an adjustable or pre-set fundamental frequency (pitch) between 80 Hz to about 350 Hz.

18. The voice generation system of any one of the previous claims, wherein the second membrane can be configured to generate a voice of an exceptionally high quality having close to flat or semi-flat harmonic spectrum with spectral harmonic peaks amplitudes varying from + / -2 dB to + / -3 dB to + / -4 dB to + / -5 dB to + / -6 dB spanning from the frequency range of 60 Hz up to 200 Hz, 60 Hz up to 300 Hz, 60 Hz up to 400 Hz, 60 Hz up to 500 Hz, 60 Hz up to 600 Hz, 60 Hz up to 700 Hz or 60 Hz up to 800 Hz, 60 Hz up to any value between 300 Hz to 1500 Hz.

19. The voice generation system of any one of the previous claims, wherein the second membrane can be configured to generate respiratory driven variable fundamental frequency (pitch) for singing.

20. The voice generation system of any one of the previous claims, wherein system can be configured to be used completely hands-free.

21. The voice generation system of any one of the previous claims, wherein the voice generation system is configured to be placed on, around or behind the neck of a human subject.

22. The voice generation system of any one of the previous claims, wherein system is configured to be placed on an ear of a human subject.

23. The voice generation system of any one of the previous claims, where the system includes adaptable or adjustable or preset parameters which enable the system to generate a voice with different pitch values across the range of 60 Hz to about 350 Hz.

24. The voice generation system of any one of the previous claims, wherein the second membrane can be configured in pre-determined sizes vary by mass, thickness, and flexibility to generate a range of selected pitch ranges with male, female or non-binaryvoice quality.

25. The voice generation system of any one of the previous claims wherein the second membrane is placed in a membrane holder, wherein the membrane holder is coupled inside the voice chamber, wherein the membrane holder can be configured to modulate the pitch or the spectrum of the sound produced by the second membrane to generate a range of selected or pre-set pitch values including male, female or non-binary voice quality.

26. The voice generation system of any one of the previous claims where the second membrane is made of natural rubber or medical grade silicone with thickness of 0.05 to 0.6 mm, and flexibility of Shore A 10-60, where changing the thickens, shape and flexibility of membranes enables the device to generate a wide range of a pitch range from 80 Hz to 350 Hz for men, women, non-binary and children.

27. The voice generation system of any one of the previous claims where the second membrane is made of thin films of silicone, natural rubber or similar flexible material cut in shapes including with straight or curved edges or specific irregularities to generate natural irregular vibrations of human vocal folds.

28. The voice generation system of any one of the previous claims wherein the second membrane is placed in a membrane holder, wherein the membrane holder is easily placed inside or removed from the voice chamber.

29. The voice generation system of any one of the previous claims, wherein the second membrane is fitted into a membrane holder in the voice chamber, wherein the membrane holder modifies respiratory airflow from a turbulent flow to a regulated sum of parallel air streams that can resonate the second membrane evenly and generate vibrations close to the natural resonance frequency of the membrane and in a frequency range of human voice.

30. The voice generation system of any one of the previous claims, where the system includes adaptable or adjustable or preset parameters which enable the system to adjust the system to work with users with different lung capacities or generate voice with respiration efforts close to tidal respiration effort for different users.

31. The voice generation system of any one of the previous claims wherein the second membrane is placed in a membrane holder, wherein the position of the membrane inside the voice chamber be adjusted via a membrane holder including using a threading mechanism to adjust the respiration effort for voice onset to the user’s lung capacity.

32. The voice generation system of any one of the previous claims wherein the first or secondmembrane parameters including thickness, shape or flexibility can be configured for the device voice generation onset to correspond to respiratory airflows closer to the tidal breathing levels of the user to minimize user fatigue.

33. The voice generation system of any one of the previous claims, wherein the first or second membrane parameters including thickness, shape or flexibility can be quantized for the voice generation system to function for a subject with low, medium or high airflow respiratory output.

34. The voice generation system of any one of the previous claims wherein the first or second membrane parameters including material and shape can be configured for the device voice generation onset to correspond respiratory airflows closer to the tidal breathing levels of the user to minimize user fatigue.

35. The voice generation system of any one of the previous claims wherein the membrane holder can be configured to minimize the pneumatic resistance of the device for voice generation to minimize user fatigue.

36. The voice generation system of any one of the previous claims where the airflow chamber first opening is in communication with the neck stoma of the user via a medical grade respiration barrier which can be: a) implemented inside and as part of the airflow chamber which may be attachable or detachable to the airflow chamber, or b) separate from the device and connected to the airflow chamber may be is attachable or detachable to the airflow chamber37. The voice generation system of any one of the previous claims where airflow chamber is in communication with the neck stoma via a stoma attachment which can be: a) part of the voice generation system which may be attachable or detachable to the device via the medical grade respiration barrier, or b) separate from the device which may be attachable or detachable to the device via the medical grade respiration barrier.

38. The voice generation system of any one of the previous claims where in the airflow chamber and the medicinal grade respiration barrier can detach from the flow tube for the voice chamber to stay in communication with the Soma Attachment and protect the airway when needed.

39. The voice generation system of any one of the previous claims where in the airflow chamber comprises a stable housing which can stay in communication with the stoma attachment when needed and a detachable housing which is in communication with theflow tube and voice chamber wherein the detachable housing can be detached from the Stable housing when needed to maintain portability of the device.

40. The voice generation system of any one of the previous claims, wherein the voice chamber comprises an exhaust mechanism that expels excessive air pressure built inside the voice chamber, thereby avoiding voice interruption, and jamming of the second membrane.

41. The voice generation system of any one of the previous claims, wherein the exhaust mechanism is mechanically or electronically activated.

42. The voice generation system of any one of the previous claims, wherein the membrane holder enables repositioning the second membrane to avoid membrane jamming and voice interruptions where in the repositioning can be mechanically or electronically activated.

43. The voice generation system of any one of the previous claims, where some or all of the components of the voice generation are disposable and replaceable.

44. The voice generation system of any one of the previous claims, wherein the first or second movable voice member is disposable and easily replaceable.

45. The voice generation system of any one of the previous claims wherein the air inlet of the voicebox chamber is in communication with the air outlet of the airflow chamber by a flow tube.

46. The voice generation system of any one of the previous claims wherein the flow tube is coupled to the airflow chamber via a mechanical grip and can be attached or detached when needed.

47. The voice generation system of any one of the previous claims wherein the flow tube is coupled to the airflow chamber via a magnetic grip and can be attached or detached when needed.

48. The voice generation system of any one of the previous claims, wherein the flow tube is coated with a condensation resistance coating including condensation resistance coating comprises a hydrophobic coating.

49. The voice generation system of any one of the previous claims, wherein parts of the device or the flow tube are made of selective semi-permeable material that lets moisture escape from the system while maintaining airflow inside the device to prevent or reduce condensation.

50. The voice generation system of any one of the previous claims, wherein the airflow chamber or The voice chamber includes one or more water trap mechanisms to remove condensation or saliva from the device, wherein the water traps are activated mechanically or electronically.

51. The voice generation system of any one of the previous claims, wherein the flow tube or oral tube includes one or more water trap mechanisms such as a piston, a double layer tube with thermal insulated walls, a double layer tube with electronically thermal insulated walls, double layer tube with condensation resistance material coating.

52. A Respiratory driven voice generation system comprising: a first movable member and a second movable member that are in communication with a respiratory airflow of a user, where the first movable member and the second movable member provide the user with automatic voice onset / offset, automatic voice generation and bidirectional breathing, a) where the first movable member is in communication with the airflow of the neck stoma of the user via a hygienic medical grade respiration barrier, b) where the first movable member functions as a multi-directional air valve enabling the user to inhale, exhale or generate voice automatically, c) where the second movable member receives the expiration airflow redirected by the first membrane to generate voice, d) where the second movable member is adjustable to generate a voice of an exceptional high quality, and e) where the second movable member is adjustable to generate a voice of different pitch including male / female or non-binary voice.

53. The voice generation system of claim 52, further comprising: an airflow chamber that houses the first movable member: a) where the airflow chamber is attached to, connects with or seals over a medical grade respiration barrier, b) where the medical grade respiration barrier is in communication with or connected to a stoma attachment, And a) where the first movable member functions as a multi-directional air valve enabling the user to inhale, exhale or generate voice automatically.

54. The voice generation system of claim 52, further comprising: an airflow chamber where the airflow chamber provides a bypass mode to disable voice generation for the user to be able to cough and breathe freely when needed without the need to remove the airflow chamber from the neck stoma.

55. The voice generation system of claim 53, further comprising: an airflow chamber where the airflow chamber and the included or attached medical grade respiration barrier can detach from the rest of the system and stay incommunication with the stoma attachment to protect the airway.

56. The voice generation system of claim 52, further comprising a voice chamber that includes the second movable member which can generate a voice of an exceptionally high-quality voice.

57. The voice generation system of claim 52, further comprising a voice chamber that uses the second movable member, where the second movable member is a membrane and a flat or semi-flat harmonic spectrum in the frequency range of 60 Hz up to any frequency value up to 1500 Hz.

58. The voice generation system of claim 52, where the first or second movable member is a flexible membrane.

59. The voice generation system of claim 52, further comprising a voice chamber where the voice chamber includes a membrane holder that can be adjusted to modify the voice chamber membrane configurations before or during use to change voice parameters including the pitch in speech or singing.

60. The voice generation system of claim 52, where the system parameters can be adjustable for the device to function comfortably with different users’ respiration power: a) where the first member is adjustable to match respiration power of different users to act as a multi-directional air valve for users over a wide range of respiratory power, b) where the second member is adjustable to match respiration power of different users to generate voice for users over a wide range of respiratory power, And c) where the membrane holder pneumatic resistance is adjustable for the device to function close to the respiratory effort of tidal breathing for different users.

61. The voice generation system of claim 52, where the generated voice is adjustable to different users’ voice preference: a) where the second member is adjustable to generate voice of selected gender including male, female or non-binary, and b) where the membrane holder is adjustable to customize the pitch or spectral contents of the generated voice.

62. The voice generation system of claim 52, where the first movable member or the second movable member can be adjusted for the device onset and offset of the voice and voice generation effort to be closer to the tidal breathing of the user to minimize user fatigue.

63. The voice generation system of claim 52, where the voice chamber or membrane holder can have customizable parameters such as adjustable pneumatic resistance to provide easy and comfortable use for people with different respiration powers including for examplepeople with small, medium, or large lung capacities.

64. The voice generation system of claim 52, further comprising an airflow chamber and a detachable portable voice chamber where the communication between airflow chamber and voice chamber can be removed when needed to provide the device with potability.

65. The voice generation system of claim 52, further comprising some disposable components or all disposable components for hygienic use.

66. The voice generation system of claim 52, where the system provides hands-free use.

67. The voice generation system of claim 52, where the medical grade respiration barrier includes a sputum / phlegm blocking feature for preventing sputum / phlegm exiting the stoma, and interrupting the normal functioning of the device.

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