Tracheotomy valve unit

• US 20040123868A1
• Filed: 12/15/2003
• Published: 07/01/2004
• Est. Priority Date: 12/16/2002
• Status: Active Grant

• Current Assignee: Pediatric Airway Innovations, LLC
• Original Assignee: Children's Hospital & Medical Center
• Inventors: Rutter, Michael John
• Granted Patent: US 7,240,676 B2
• Time in Patent Office: Days
• US Class Current: 128/207.14
• CPC Class Codes: A61M 16/0468 with valves at the proximal end limiting exhalation, e.g. during speaking or coughing air passages from trachea to oesophagus or to pharynx, artificial epiglottis A61F2/203
• CPC Class Codes: A61M 16/206 Capsule valves, e.g. mushroom, membrane valves
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: Y10T 137/778 Axes of ports co-axial

Abstract

A tracheotomy valve unit for use with a tracheotomy tube inserted into a patient'"'"'s trachea comprises a first end for connection to the tracheotomy tube, a second end comprising a valve unit inlet, a first valve that permits airflow to the tube when the patient inhales and blocks airflow from the tube when the patient exhales thereby permitting speech, and a second valve that permits airflow from the tube back out the valve unit when the intrathoracic pressure during expiration is greater than about 12 cm of water. The second valve functions as a pressure release valve that increases tolerance and wearing comfort. In one embodiment, the second valve comprises a slit valve or an umbrella valve.

Claims

1. A tracheotomy valve unit adapted to cooperate with a tracheotomy tube inserted into a patient'"'"'s trachea, said valve unit comprising:

(a) a first end adapted for connection to the free end of the tracheotomy tube;

(b) a second end comprising a valve unit inlet;

(c) a first valve that permits airflow from the valve unit inlet through the valve unit and to the tube in the patient'"'"'s trachea when the patient inhales, and blocks airflow from the tube through the valve unit when the patient exhales; and

(e) a second valve that permits airflow from the tube through the valve unit and out the valve unit when the intrathoracic pressure during expiration is greater than about 12 cm of water, and blocks such airflow when the intrathoracic pressure during expiration is less than about 3 cm of water.

2. The valve unit of claim 1 comprising a seating ring and a thin, flexible diaphragm biased against the seating ring, thereby making positive closure contact therewith.

3. The valve unit of claim 2 wherein the diaphragm is made of silicone sheet material.

4. The valve unit of claim 2 wherein the diaphragm is biased against the seating ring by a pressure of from about 8 to about 15 mm of water head.

5. The valve unit of claim 2 comprising a rivet for connecting the diaphragm to the seating ring, the rivet having a length to bias the diaphragm against the seating ring.

6. The valve unit of claim 5 wherein the rivet has an axial bore hole through it and comprises the second valve.

7. The valve unit of claim 6 wherein the second valve comprises a slit valve or an umbrella valve.

8. The valve unit of claim 7 wherein the diaphragm is biased against the seating ring by a pressure of from about 8 to about 15 mm of water head.

9. The valve unit of claim 8 wherein the diaphragm is made of low-modulus silicone sheet material.

10. The valve unit of claim 9 wherein the second valve permits airflow from the tube through the valve unit and out the valve unit when the intrathoracic pressure during expiration is greater than about 10 cm of water, and blocks airflow when the intrathoracic pressure during expiration is less than about 4 cm of water.

11. The valve unit of claim 1 wherein the second valve permits airflow from the tube through the valve unit and out the valve unit when the intrathoracic pressure during expiration is greater than about 10 cm of water, and blocks airflow when the intrathoracic pressure during expiration is less than about 4 cm of water.

12. The valve unit of claim 11 wherein the second valve comprises a slit valve or an umbrella valve.

13. The valve unit of claim 12 comprising a seating ring and a thin, flexible diaphragm biased against the seating ring, thereby making positive closure contact therewith.

14. The valve unit of claim 13 comprising a rivet for connecting the diaphragm to the seating ring, the rivet having a length to bias the diaphragm against the seating ring.

15. The valve unit of claim 14 wherein the second valve is located in the rivet.

16. The valve unit of claim 1 wherein the second valve begins to open to permit airflow from the tube through the valve unit and out the valve unit when the intrathoracic pressure during expiration is about 4 cm of water, and is fully open when the intrathoracic pressure during expiration is about 10 cm of water.

17. The valve unit of claim 16 wherein the second valve comprises a slit valve or an umbrella valve.

18. The valve unit of claim 17 comprising a seating ring and a thin, flexible diaphragm biased against the seating ring, thereby making positive closure contact therewith.

19. The valve unit of claim 18 comprising a rivet for connecting the diaphragm to the seating ring, and the rivet having a length to bias the diaphragm against the seating ring.

20. The valve unit of claim 19 wherein the second valve is located in the rivet.

21. A tracheotomy valve unit adapted to cooperate with a tracheotomy tube inserted into a patient'"'"'s trachea, said valve unit comprising:

(a) a first end adapted for connection to the free end of the tracheotomy tube;

(b) a second end comprising a valve unit inlet;

(c) a first valve that permits airflow from the valve unit inlet through the valve unit and to the tube in the patient'"'"'s trachea when the patient inhales, and blocks airflow from the tube through the valve unit when the patient exhales, said first valve comprising a seating ring, a thin, flexible diaphragm biased against the seating ring, thereby making positive closure contact therewith, and a rivet for connecting the diaphragm to the seating ring, the rivet having a length to bias the diaphragm against the seating ring; and

(d) a second valve that permits airflow from the tube through the valve unit and out the valve unit when the intrathoracic pressure during expiration is greater than about 12 cm of water, and blocks such airflow when the intrathoracic pressure during expiration is less than about 3 cm of water, wherein the second valve comprises a slit valve or an umbrella valve that is located in an axial bore hole of the rivet.

22. The valve unit of claim 21 wherein the diaphragm is made of low-modulus silicone sheet material.

23. The valve unit of claim 22 wherein the second valve permits airflow from the tube through the valve unit and out the valve unit when the intrathoracic pressure during expiration is greater than about 10 cm of water, and blocks airflow when the intrathoracic pressure during expiration is less than about 4 cm of water.

24. The valve unit of claim 22 wherein the second valve begins to open to permit airflow from the tube through the valve unit and out the valve unit when the intrathoracic pressure during expiration is about 4 cm of water, and is fully open when the intrathoracic pressure during expiration is about 10 cm of water.

25. The valve unit of claim 24 wherein the second valve allows increasing airflow through it as the intrathoracic pressure during expiration increases beyond 4 cm of water until maximum airflow is achieved at a pressure of about 10 cm of water.