Patent Application
20140107780
This invention relates in general to prosthetic medical devices and more particularly to voice prosthesis devices.
I, Bob Perry, inventor of the present invention, underwent a laryngectomy operation. As a result of the laryngectomy procedure, a tracheal-esophageal puncture was performed and I received a voice prosthesis installed in the resulting stoma. I also wear an endostomal tracheostoma button and accompanying tracheostoma valve for breathing purposes. I have experienced annoying difficulties with regard to fluid leakage between my trachea and esophagus past the voice prosthesis device. When my voice prosthesis has a fluid leak, food and fluids that I consume pass from my esophagus and into my trachea or windpipe with irritating results. Such leaks occur as a result of ineffective seals in the voice prosthesis device. When leaks occur, I am forced to remove the tracheostoma valve and tracheostoma button and cough to expel fluid or food from my windpipe and lungs. Coughing is, at the least, quite a process to accomplish as well as publicly embarrassing for a laryngectomy patient.
The typical remedy for fluid leaks past the voice prosthesis device is the installation of a new voice prosthesis, normally installed by medical professionals who provide my care. Unfortunately, the new voice prosthesis does not have a reliable fluid seal design and fluid leaks occur rather soon after a replacement voice prosthesis is installed. It occurred to me that a smooth cylindrical surface with circular flanges at the ends thereof is not a very effective fluid seal design given the environment where my voice prosthesis is placed and the fluid seal issues at that location, including the depth or length of my trachea-esophagus puncture and the size or geometry of the puncture.
What is needed is a better voice prosthesis device with an improved fluid seal design. I have endeavored to improve the design of an existing voice prosthesis devices, in particular, the fluid seal between the trachea and esophagus, by altering the external surfaces of an existing voice prosthesis. The following invention description details my design improvement for such voice prosthesis devices.
A voice prosthesis device, according to one aspect of the present invention, comprises a hollow cylindrical tube having an external lateral surface, a first open end, a second open end, and at least one annular protrusion extending radially outward a fixed distance from the external lateral surface of the hollow cylindrical tube, and wherein the radius of the tube is sized for insertion into a stoma connecting a users trachea and esophagus, low pressure check valve means for allowing air to pass through the cylindrical tube when air pressure on one side of the cylindrical tube exceeds a predetermined level, the valve means being disposed within the cylindrical tube, a first retainer flange attached over the first open end of the hollow cylindrical tube, the first retainer flange having a disk-like shape and an aperture aligned with the first open end, and a second retainer flange attached over the second end of the hollow cylindrical tube, the second retainer flange having a disk-like shape and an aperture aligned with the second open end.
One object of the present invention is to provide an improved voice prosthesis device.
Another object of the present invention is to improve the fluid seals for a voice prosthesis device disposed in a stoma communicating between the trachea and the esophagus.
Yet another object of the present invention is to extend the life expectancy of voice prosthesis devices after installation thereof.
These and other objects of the present invention will become more apparent from the following description of the preferred embodiments.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated devices, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
Referring now to
Referring now to
The typical length of prosthesis 10, the distance between retainer flanges 12 and 14 for the cylindrical portion 24 of voice prosthesis 10, varies from 6 to 28 millimeters and typical cylindrical diameters for surface 24 are between 16 and 20 FR. FR represents French scale where 1 FR=⅓ mm. The height above surface 24, width and spacing of annular seals 22 may be varied so that from patient to patient, the best fluid seal results are achieved. A typical height for rib seals 22 is 0.010 to 0.030 inches, though it may be necessary in certain circumstances to vary the height dimension outside this range based upon the application of prosthesis 10 to a particular patient. Separation spacing between rib seals 22 may be varied to achieve optimal results. Although three rib seals 22 are shown in
Voice prosthesis 10 is fabricated in a variety of lengths and cylindrical diameters to accommodate the varying dimensions of an individual patient's tracheal-esophageal stoma wherein prosthesis 10 is placed. Prosthesis 10 may be fabricated from a semi-rigid resilient and flexible silicone compound that is readily sterilized, though other suitable materials are contemplated. Any well known geometric contour is contemplated for the cross-sectional profile of seals 22, including but not limited to semi-circular or round, elliptical, hexagonal, or the like. Most importantly, seals 22 should have a cross-sectional profile that is rounded and non-irritating to the patient. Check valve 16 is a simple flap type valve that is integrally formed in device 10 and fabricated to pivot along a thin portion of flap 16 at 16a.
Referring now to
The improvement over the prior art discussed herein is applicable to all voice prosthesis devices presently known in the art wherein a cylindrical body and disk like retainer flanges attached over the ends of the cylindrical body are used. The addition of rib seals to any prior art device will enhance the fluid seal thereof for users of voice prosthesis devices.
While the invention has been illustrated and described in detail in the drawings and foregoing description of the preferred embodiments, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiments have been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.
