Surgery – Respiratory method or device – Respiratory gas supply means enters mouth or tracheotomy...
Reexamination Certificate
2002-05-13
2004-10-12
Dawson, Glenn K. (Department: 3731)
Surgery
Respiratory method or device
Respiratory gas supply means enters mouth or tracheotomy...
C128S207150, C128S207160, C128S207180
Reexamination Certificate
active
06802316
ABSTRACT:
CROSS-REFERENCE TO RELATED APPLICATIONS
Not Applicable
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable
BACKGROUND OF THE INVENTION
(1) Field of the Invention
The present invention relates to a tracheostomy valve which prevents air from exiting the tracheostomy tube of a user while allowing air to enter the tracheal tube. In particular, the present invention relates to a tracheostomy valve which is aesthetically pleasing and has a low profile.
(2) Description of the Related Art
The related art has shown various types of unidirectional tracheostomy valves that mount on the end of the tracheal tube, which is inserted into the patient's trachea after a tracheostomy. Such tracheostomy valves allow air to flow through the tracheal tube and into the lungs during inhalation and prevent air from flowing through the tracheal tube during exhalation. Thus, during exhalation, air flows through the patient's upper airways, such as the subglottic trachea, larynx, pharynx, mouth and nasal passages. As a result, tracheotomized individuals using a unidirectional tracheostomy valve are able to communicate orally and maintain clear upper airway passages by coughing or expelling air through the upper airway passages.
U.S. Pat. No. 5,505,198 to Siebens et al describes a tracheostomy valve having a displaceable element, such as A ball, in a chamber. The ball moves about during inhalation and exhalation to open or close an opening in the chamber. However, due to the use of a ball and the size of the ball needed to cover the opening, this device can not be streamlined as with the device of the present invention.
There remains the need for a unidirectional tracheostomy valve which is streamlined with a low profile and which allows a user to inhale through the valve and exhale through the mouth.
SUMMARY OF THE INVENTION
A tracheostomy valve having a low profile for use on a tracheal tube of a user. The tracheostomy valve is a unidirectional valve which allows gases to enter through the tracheostomy valve and into the tracheal tube but does not allow gases to exit the tracheal tube through the tracheostomy valve. The tracheostomy valve enables a user to speak without having to manually block the,tracheal tube. The valve includes a valve body, a flapper valve, a valve clamp and a cover. The construction of the tracheostomy valve allows the tracheostomy valve to have a low profile. The valve body has notches in the perimeter of the sidewall extending the length of the sidewall between the ends of the valve body. The notches provide inlets for the gases to move past the valve body. The valve body has a tubular extension on the first end which is inserted into the opening of the tracheal tube of the user. The valve body has a hole with a first, second and middle section. The middle section is greater in size than the first section and the second section is greater in size than the middle section. Thus, an indention is formed in the second end of the valve body which is in fluid communication with the hole of the valve body, the hole of the tubular extension and the opening of the tracheal tube. The flapper valve is positioned in the second section of the hole in the valve body. The flapper valve has an outer portion connected to an inner portion. The flapper valve is constructed of a thin, flexible material. The valve clamp is also positioned in the second section of the hole of the valve body so that the flapper valve is sandwiched between the first end of the valve clamp and the shoulder formed between the second and middle sections of the hole of the valve body. The valve clamp has a hole which is in fluid communication with the hole of the valve body. The second end of the valve clamp has grooves which extend from the perimeter of the valve clamp to the hole in the valve clamp. The grooves provide inlets for the gases to move past the valve clamp into the hole of the valve clamp and into the hole of the valve body. The cover mounts over the second end of the valve body and holds the valve clamp and flapper valve in position in the second section of the hole of the valve body. The cover can have a decorative second side to increase the aesthetic appearance of the tracheostomy valve. In one (1) embodiment, the valve body and the cover have a cylindrical shape and the cover is screwed onto the valve body.
The valve body has a connector on the first end which allows the tracheostomy valve to be securely connected to the tracheal tube. Once the tracheostomy valve is positioned on the tracheal tube, the user can inhale through the tracheostomy valve. When exhaling, the tracheostomy valve prevents the exit of gases through the tracheostomy valve such that the gases move to the mouth which allows for speech. When a user inhales, the gases adjacent the tracheostomy valve move between the valve body and the sidewall of the cover in the notches in the valve body. The gases then move between the end wall of the cover and the second end of the valve clamp in the grooves of the valve clamp and into the hole of the valve clamp. The gases then move past the open flapper valve. The suction force resulting from the user inhaling and the force of the air moving through the tracheostomy valve, causes the inner portion of the flapper valve to move toward the middle section of the hole of the valve body and away from the outer portion of the flapper valve. This creates an opening between the outer and inner portions of the flapper valve and allows the gases in the hole of the valve clamp to move into the hole in the valve body. Once the gases are in the hole of the valve body, the gases move through the tubular extension and into the tracheal tube and finally to the lungs of the user.
During exhalation, the gases in the lungs move into the tracheal tube through the tubular extension and into the first and middle sections of the hole of the valve body. As the gases attempt to move from the middle section to the second section of the hole, the gases push against the inner portion of the flapper w valve moving the inner portion toward the valve clamp. When the inner portion contacts the valve clamp it blocks the hole in the valve clamp and prevents the gases from moving past the flapper valve. Since the exhaled gases can not escape through the tracheostomy valve, the gases continue to move up the throat of the user past the larynx and into the mouth of the user. Since the air moves past the vocal cords of the user, the user is able to speak without having to remove or adjust the tracheostomy valve.
The present invention relates to a tracheostomy valve for connecting to a tracheal tube, which comprises: a valve body having a first end and a second end with a hole extending between the ends and having an inlet spaced apart from the hole; a tubular extension mounted on the first end of the valve body and extending outward from the first end in a direction opposite the second end and having a hole in fluid communication with the hole of the valve body; a flapper valve positioned adjacent the hole of the valve body on the second end of the valve body and having an outer portion and an inner portion connected together so that the inner portion is able to move while the outer portion remains stationary; a valve clamp having a first end and a second end with a hole extending between the ends and positioned such that the first end of the valve clamp is adjacent the flapper valve and the hole of the valve clamp is in fluid communication with the flapper valve; and a cover positioned adjacent the second end of the valve clamp for connecting to the valve body to hold the valve clamp and the flapper valve adjacent the hole of the valve body wherein in use during inhalation, gases flow into the inlet of the valve body from the first side of the valve body to the second side of the valve body into the hole in the valve clamp, through the flapper valve into the hole of the tubular extension and into the tracheal tube and wherein during exhalation, the flapper valve prevents gases from exiting the trache
Dawson Glenn K.
Erezo Darwin P.
McLeod Ian C.
Moyne Mary M.
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