CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No.

61/940,525, filed on February 17, 2014, which is incorporated by reference herein, in its entirety. This application is also related to U.S. Provisional Patent Application No.

61/641,431 filed on May 2, 2012 and U.S. Provisional Patent Application No. 61/823,540 filed on May 15, 2013, both of which are incorporated by reference, herein, in their entirety.

FIELD OF THE INVENTION

[0002] The present invention relates generally to a device for producing speech. More particularly, the present invention relates to a device for insufflating a tracheoesophageal prosthesis.

BACKGROUND OF THE INVENTION

[0003] Laryngectomy is a common procedure for advanced and recurrent laryngeal cancer and has a high rate of success. The procedure involves removing the larynx (voice box) and bringing the trachea directly to the skin in the lower neck. However, patients undergoing a laryngectomy are no longer capable of producing normal voice. Various forms of vocal rehabilitation exist, including esophageal speech, external vibratory devices (electro-larynx), assistive speech devices, and tracheoesophageal (TE) speech.

[0004] TE speech relies on the placement of a small prosthesis with a one-way valve that spans the trachea and esophagus and allows for the shunting of air from the trachea into the esophagus when the stoma is occluded. The shunted air creates vibration and sound within the pharynx that can be articulated into understandable speech. In order to occlude the stoma the patient has to manually close it with a finger or cap. Not only is this cumbersome for a patient and potentially awkward when interacting with those not familiar with TE speech, but many patients don't have the coordination and dexterity necessary to properly occlude their stoma to produce fluent speech. Indeed, approximately 80% of patients are successful with TE speech, but many decide not to voice or use it less than they'd like because of the discomfort and challenge of occluding the stoma to produce speech.

[0005] It would therefore be advantageous to provide a device for a patient to use to produce a tracheoesophageal speech without having to elevate his/her fingers to occlude a stoma.

SUMMARY OF THE INVENTION

[0006] The foregoing needs are met, to a great extent, by the present invention, wherein in one aspect a device for facilitating tracheoesophageal speech in a patient having a

tracheoesophageal prosthesis includes an insufflator. The insufflator includes a housing defining an opening and is configured to provide a flow of gas through the opening. The device includes a tube having a first end and a second end and also having an outer wall defining a central lumen extending longitudinally through a length of the tube. The first end of the tube is connected to the opening of the insufflator with a first fluid communication coupling, and the second end of the tube is connected to an opening on the tracheoesophageal prosthesis with a second fluid communication coupling. A fluid flow path is defined by the first fluid communication coupling between the insufflator and the tube and the second fluid communication coupling between the tube and the tracheoesophageal prosthesis. The fluid flow path provides that fluid can flow from the insufflator through the tube and out through the opening of the tracheoesophageal prosthesis.

[0007] In accordance with another embodiment of the present invention, the device can include a safety valve positioned within the opening of the insufflator. A heat and moisture exchange (HME) device can also be incorporated into the device. The insufflator further can take the form of a canister insufflator or air compression insufflation. Additionally, the insufflator can include a remote power switch. [0008] In accordance with yet another embodiment of the present invention, a method of providing speech to a patient using a tracheoesophageal prosthesis includes attaching a first end of a tube to an opening defined by the tracheoesophageal prosthesis. The method further includes attaching a second end of the tube to an insufflator, and activating the insufflator such that the patient can produce speech.

[0009] In accordance with still another aspect of the present invention, the insufflator takes the form of air compression insufflation or a canister insufflator. The tone of the patient's voice can also be changed by using a predetermined mix of gases in a canister of the canister insufflator.

[0010] In accordance with another aspect of the present invention, a system for providing speech to a patient using a tracheoesophageal prosthesis includes an air compressor assembly having an air compressor, a battery, and a carrying device. The system includes elongate tubing having a lumen extending therethrough connecting the air compressor to the tracheoesophageal prosthesis. The system also includes a voicing button configured to allow the patient to allow air through the tracheoesophageal prosthesis.

[0011] In accordance with yet another aspect of the present invention, the battery is removable and rechargeable. Alternately, the battery is removable and replaceable. The system can further include a power cord. The air compressor includes an off switch, a standby switch, an on switch, and a therapy switch. The voicing button includes a valve disposed on the tubing that the patient can cover and allow air to flow through the tracheoesophageal prosthesis to enable voice production. The voicing button can alternately include a button on a small device that wirelessly sends a signal to an air valve in the system of allow air to flow through the tracheoesophageal prosthesis to enable voice production. The small device comprises one selected from a group consisting of a ring, a keychain, a pen, and jewelry. The signal being sent wirelessly using Bluetooth. An adhesive member is used to keep the tubing immobilized at a stoma of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings provide visual representations which will be used to more fully describe the representative embodiments disclosed herein and can be used by those skilled in the art to better understand them and their inherent advantages. In these drawings, like reference numerals identify corresponding elements and:

[0013] FIG. 1 illustrates a device including a tracheoesophageal prosthesis, tube, and insufflator according to an embodiment of the invention.

[0014] FIG. 2 illustrates a partially sectional view of a patient with a tracheoesophageal prosthesis inserted and tube installed according to an embodiment of the invention.

[0015] FIG. 3 illustrates a diagram of a method of providing speech to a patient with a tracheoesophageal prosthesis according to an embodiment of the invention.

[0016] FIG. 4 illustrates a schematic diagram of a system for aiding a patient in speech, according to an embodiment of the invention.

DETAILED DESCRIPTION

[0017] The presently disclosed subject matter now will be described more fully hereinafter with reference to the accompanying Drawings, in which some, but not all embodiments of the inventions are shown. Like numbers refer to like elements throughout. The presently disclosed subject matter may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Indeed, many modifications and other embodiments of the presently disclosed subject matter set forth herein will come to mind to one skilled in the art to which the presently disclosed subject matter pertains having the benefit of the teachings presented in the foregoing descriptions and the associated Drawings. Therefore, it is to be understood that the presently disclosed subject matter is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims.

[0018] An embodiment in accordance with the present invention provides a device and method for providing speech to a patient using a tracheoesophageal (TE) prosthesis. The device includes a tube and an insufflator to be connected in fluid communication to the TE prosthesis. A first end of the tube is coupled to the TE prosthesis while a second end of the tube is coupled to the insufflator, creating a flow path for fluid from the insufflator to reach the TE prosthesis. When the patient wishes to speak, the insufflator is activated creating the necessary vibration in the pharynx, such that the patient can articulate those vibrations into speech. The insufflator can take the form of a canister insufflator or an air compressor insufflator, and can be controlled with a remote control switch.

[0019] FIG. 1 illustrates a device including a TE prosthesis, tube, and insufflator according to an embodiment of the invention. The device 10 includes a TE prosthesis 12. A tube 14 is coupled to the TE prosthesis 12 and also to an insufflator 16. The TE prosthesis 12 can take the form of any suitable TE prosthesis known to one of skill in the art. Here, the TE prosthesis 12 is illustrated with a first end flange 18 and a second end flange 20. The first end flange 18 is connected to the second end flange 20 by a generally cylindrical conduit 22. The first end flange 18 defines a first opening 24 and the second end flange 20 defines a second opening (not pictured). The generally cylindrical conduit 22 has an outer wall 26 which defines a lumen (not pictured), extending from the first opening 24 to the second opening, such that a fluid can travel into the TE prosthesis 12 through the first opening 24 through the generally cylindrical conduit 22 and out through the second opening. The TE prosthesis 12 can also include a securement tab 28 extending from the first end flange 18. The securement tab 28 can be adhered to the skin of the patient's neck. The TE insufflator 12 can be formed from a plastic, silicon,or any other suitable material known to one of skill in the art.

[0020] FIG. 1 also illustrates the tube 14 being coupled to the TE prosthesis 12. The tube 14 includes a first end 30 and a second end 32. The tube also includes an outer wall 34 that defines a lumen extending though a longitudinal length of the tube 14. The tube can be formed from plastic or rubber, or another suitable and flexible material known to one of skill in the art. The first end 30 of the tube 14 is coupled to the first opening 24 of the TE prosthesis 12. The coupling can be frictional, such as the tube 14 being inserted into the first opening 24 and held frictionally within the first opening 24. This can be achieved by any frictional means available such as by a wall of the first opening 24 or a gasket disposed within the first opening 24. Alternately, the coupling can be achieved with a mechanical coupling, such as a luer connector, with an adhesive coupling, such as a glue, or with any other suitable coupling known to one of skill in the art. The second end 32 of the tube 14 is coupled to an opening 35 of the insufflator 16. This coupling can be similar to that described for the coupling of the first end 30 to the first opening 24. Additionally the opening 35 of the insufflator can include a safety valve to prevent any inadvertent increases in pressure above what is physically tolerable in the pharynx.

[0021] The couplings are configured such that the TE prosthesis 12, tube 14, and insufflator 16 are all in fluid communication. For instance, when the insufflator 16 is activated fluid flows out though the opening of the insufflator 16 into the tube 14, through the tube 14 into the TE prosthesis 12, and out through the second opening of the TE prosthesis 12 into the patient's esophagus. Therefore, a fluid flow path 36 is established from the insufflator 16 to the patient's pharynx. [0022] As illustrated in FIG. 1 the insufflator 16 can take the form of a canister insufflator, or alternately can take the form of an air compressor insufflator or any other type of insufflator known to one of skill in the art that could be used to provide gas through the fluid flow path. The canister insufflator 16 includes a pressurized gas canister 38 containing room air or an inert gas. The canister can also be filled with a mix of gases in order to affect the tone of the patient's voice. The canister 16 can be worn on the patient's body, such as on the hip or in a backpack. When activated by a control switch 40, such as a remote control finger switch, the device will allow for controlled release of gas into the tube, thereby producing TE speech. Alternately, if an air compressor is used, the compressor can be portable and rechargeable, such as with batteries. The air compressor delivers room air into the tube 14 and through the TE prosthesis 12. When activated by the control switch 40, the device will allow for controlled release of air into the tube 14, thereby producing TE speech. The air compressor type insufflator can also be worn, such as on the hip or in a backpack.

[0023] FIG. 2 illustrates a partially sectional view of a patient with a tracheoesophageal prosthesis inserted and tube installed according to an embodiment of the invention. As illustrated in FIG. 2, a patient 42 has the TE prosthesis 12 in place and connecting the trachea 44 to the esophagus 46. The securement tab 28 extends out of a tracheal stoma 48 and is secured to an outside skin surface 50 of the neck 52 of the patient 42. The tube 14 is coupled to the TE prosthesis and extends out though the tracheal stoma 48. The tube 14 is secured to the upper chest 54 of the patient 42 using tape 54 or another suitable skin compatible adhesive. The tube 14 can continue down under the patient's clothing to couple to the insufflator (not pictured). Fluid travels through the tube 14 into the TE device 12 and into the patient's esophagus, as illustrated by flow path 36. The patient 42 can also wear a heat and moisture exchange (HME) device adapted with an opening for the tube 14 with this device. [0024] FIG. 3 illustrates a diagram of a method of providing speech to a patient with a tracheoesophageal prosthesis according to an embodiment of the invention. The method 100 can include step 110 of attaching a first end of a tube to an opening defined by the tracheoesophageal prosthesis. Another step 120 can include attaching a second end of the tube to an insufflator, and step 130 can include activating the insufflator such that the patient can produce speech. The insufflator can take the form of a canister insufflator or an air compressor insufflator, as described above. Additionally, the method can include changing the tone of the patient's voice by using a predetermined mix of gases in a canister of the canister insufflator.

[0025] FIG. 4 illustrates a schematic diagram of a system for aiding a patient in speech, according to an embodiment of the invention. The system 100 includes an air compressor assembly 102 and a tracheoesophageal prosthesis 104. Tubing 106 is used to connect the air compressor 102 to the tracheosophageal prosthesis 104. More particularly, the air compressor assembly 102 includes an air compressor 108 and a battery pack 110. The battery pack 110, preferably, is detachable from the air compressor assembly 102 and also rechargeable and/or replaceable. The system can also include a power cord for charging the battery or for providing power directly to the air compressor 108. The air compressor assembly 102 also includes a carrying device 112. The carrying device 112 can take the form of a fanny pack, backpack, shoulder bag or any other suitable carrying means known to or conceivable by one of skill in the art. The air compressor 108 includes several settings to enable use of the system. For instance, the air compressor 108 includes an off switch to allow the user to remain silent and a standby switch to allow for infrequent speech. The air compressor 108 also includes an on switch for periods of constant speech, and a therapy switch for continual insufflation to improve pliability of the neo-pharynx. The air compressor can take the form of a CPAP treatment system, a modified CPAP treatment system, or other similar source of air flow.

[0026] Further with respect to FIG. 4, the patient can be given additional control of the system 100 with a voicing button 114. The voicing button 114 works in conjunction with a valve either in the air compressor 108, tubing 106, or the tracheoesophageal prosthesis 104. For instance, the voicing button 114 can take the form of a valve along the tubing 106 that the patient can cover to allow air to flow through the tracheoesophageal prosthesis 104.

Alternately, the voicing button 114 can take the form of a button enabled with wireless communication on a ring, keychain, pen, piece of jewelry, etc. that sends a signal to the system 100 to open an air valve and enable voice production. The wireless communication can take the form of Bluetooth or any other suitable wireless communication protocol known to or conceivable by one of skill in the art. The system 100 can include a microprocessor or other computing device for actuating opening and closing of an air valve to enable voice production. This microprocessor can be incorporated into or can be in communication with the air compressor 108 in order to open and close the valve to enable voice production. The system 100 also includes adhesive tape 116 or other suitable means for keeping the tubing 106 immobilized at the patient's stoma.

[0027] It should also be noted that the patient or a medical professional can change pressure of the air flow generated by the air compressor. For instance, it may be necessary to adjust the air pressure for a particular patient depending on certain conditions. Air flow pressure also may need to be varied patient by patient and no one air flow pressure would be correct for all users of the system. In this way the system 100 can be customized for each individual user.

[0028] While this device has been described for use in tracheoesophageal speech, it need not be limited to this application and could be used for different applications known to one of skill in the art. The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.