Ventilation interface for sleep apnea therapy

• US 20020092527A1
• Filed: 03/14/2002
• Published: 07/18/2002
• Est. Priority Date: 03/13/2000
• Status: Active Grant

• Current Assignee: Salter Labs, LLC
• Original Assignee: Innomed Technologies Incorporated (SunMed Group Holdings LLC)
• Inventors: Wood, Thomas J.
• Granted Patent: US 6,776,162 B2
• Time in Patent Office: Days
• US Class Current: 128/207.18
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2205/42 Reducing noise

Abstract

The ventilation interface for sleep apnea therapy interfaces a ventilation device to the patient'"'"'s airways. The ventilation interface includes a pair of nasal inserts made from flexible, resilient silicone which are oval shaped in cross-section and slightly tapered from a base proximal the ventilation supply to the distal tip end. A bead flange is disposed about the exterior of each insert at the distal end of the insert. In one embodiment, a valve is disposed between the nasal inserts and a source of positive airway pressure, the valve having a rim with a one-way diaphragm pivotally attached to the valve body with an inflatable bladder depending from the rim which seals against an exit port during inspiration and deflates to uncover the exit port on expiration. Another embodiment has nasal inserts without positive airway pressure but with a removable filter in the inserts for filtering inspired air.

Claims

1. A ventilation interface, comprising:

(a) a pair of nasal inserts, each nasal insert being a hollow body made from a flexible, resilient, soft, biocompatible material, each nasal insert having a base end adapted for connection to a ventilator air flow and an open distal tip end, each nasal insert being substantially oval in cross-section at the base end and the distal end and continuously oval in cross-section between the base end and the distal end; and

(b) a flange formed as a bead disposed about the distal tip end of each said nasal insert, the flange being adapted for forming a seal against a naris of a patient'"'"'s nose;

(c) wherein each said nasal insert is capable of being compressed and inserted into the patient'"'"'s naris to a patient'"'"'s mucosal membrane and being retained therein solely by said flange, by the resilience of said nasal insert, and by lateral pressure against the naris from ventilator air flow through each said nasal insert.

2. The ventilation interface according to claim 1, wherein each said nasal insert is made from silicone.

3. The ventilation interface according to claim 1, wherein each said nasal insert has an internal diameter of 0.75 inches on a major axis and 0.5 inches on a minor axis.

4. The ventilation interface according to claim 1, wherein each said nasal insert has a wall thickness between about {fraction (1/32)} and {fraction (1/20)} inches.

5. The ventilation interface according to claim 1, wherein each said nasal insert has a softness measuring between about 15 and 40 on a type A Shore durometer.

6. The ventilation interface according to claim 1, further comprising a pair of valves, each of the valves including a hollow valve body defined by at least one sidewall and having a superior end and an inferior end, the base of each said nasal insert being attached to the superior end of one of said valve bodies, respectively, in order to form a continuous air conduit.

7. The ventilation interface according to claim 6, further comprising a pair of supply tubes for delivering a gas from a ventilator, the inferior end of each of said valve bodies being connected to a separate one of the pair of supply tubes so that each said nasal insert is independently supplied with gas from the ventilator.

8. The ventilation interface according to claim 6, wherein each said valve further comprises:

(a) an exit port defined in said at least one sidewall, the exit port being formed by a mesh grid;

(b) a hinge attached to said at least one sidewall opposite said exit port;

(c) a gate pivotally attached to said hinge, the gate having a rigid rim defining the perimeter of the gate and a one-way, gas permeable diaphragm extending across the rim; and

(d) a flexible, tubular bladder having a first end attached to the rim of said gate and an open second end attached to the side wall of said valve body;

wherein said gate pivots between a first position during inspiration in which the rim of said gate is above said exit port, said bladder inflating to form a seal over said exit port, and a second position during expiration in which the rim of said gate is below said exit port, opening said exit port for release of exhaled air to the atmosphere.

9. The ventilation interface according to claim 8, wherein said one-way diaphragm permits inflow of inspired air from the inferior end of said valve body through said diaphragm and the superior end of said valve body, but blocks outflow of exhaled air in a direction opposite to inflow.

10. The ventilation interface according to claim 8, wherein each said valve further comprises a stop extending from the sidewall of said valve body positioned above said exit port in order to limit travel of said gate during inspiration.

11. The ventilation interface according to claim 8, wherein each said valve further comprises a stop post extending from the sidewall of said valve body positioned below said exit port in order to limit travel of said gate during expiration.

13. The ventilation interface according to claim 12, wherein said one-way diaphragm permits inflow of inspired air from the inferior end of said valve body through said diaphragm and the superior end of said valve body, but blocks outflow of exhaled air in a direction opposite to inflow.

14. The ventilation interface according to claim 12, wherein said valve further comprises a stop extending from said valve body positioned above said exit port in order to limit travel of said gate during inspiration.

15. The ventilation interface according to claim 12, wherein said valve further comprises a stop post extending from said valve body positioned below said exit port in order to limit travel of said gate during expiration.

17. The ventilation interface according to claim 16, wherein said filter is capable of filtering at least one irritant selected from the group consisting of dust, pollen, allergens and bacteria from inhaled air.

18. The ventilation interface according to claim 16, wherein said retaining means comprises an elastic mesh disposed over said inspiratory diaphragm.

12. A ventilation interface, comprising:

(a) a nasal insert, the nasal insert being a hollow body made from a flexible, resilient, soft, biocompatible material, having a base end and a tip end, the nasal insert being substantially oval in cross-section at the base end and the tip end and continuously oval in cross-section between the base end and the tip end;

(b) a flange formed as a bead disposed about the tip end of said nasal insert, the flange being adapted for forming a seal against a naris of a patient'"'"'s nose; and

(c) a valve having a hollow valve body including a superior end attached to the base end of said nasal insert and an inferior end adapted for attachment to supply tubing from a ventilator, the valve having;

(i) an exit port defined in said valve body;

(ii) a gate pivotally attached to said valve body, the gate having a rigid rim and a one-way gas permeable diaphragm extending across the rim; and

(iii) a flexible, tubular bladder having a first end attached to the rim of said gate and an open second end attached to said valve body;

(d) wherein said nasal insert is capable of being compressed and inserted into the patient'"'"'s naris to a patient'"'"'s mucosal membrane and being retained therein solely by said flange and by the resilience of said nasal insert; and

(e) wherein said gate pivots between a first position during inspiration in which the rim of said gate is above said exit port, said bladder inflating to form a seal over said exit port, and a second position during expiration in which the rim of said gate is below said exit port, opening said exit port for release of exhaled air to the atmosphere.

16. A ventilation interface, comprising:

(a) a nasal insert, the nasal insert being a hollow body made from a flexible, resilient, soft, biocompatible material, having a base end and a tip end, the nasal insert being substantially oval in cross-section at the base end and the tip end and continuously oval in cross-section between the base end and the tip end;

(b) a flange formed as a bead disposed about the tip end of said nasal insert, the flange being adapted for forming a seal against a naris of a patient'"'"'s nose;

(c) a one-way expiratory diaphragm disposed across the base end of said nasal insert, the expiratory diaphragm permitting passage of exhaled air from the tip end through the base end, but preventing passage of inhaled air through the base end towards the tip end;

(d) a one-way inspiratory diaphragm disposed in said nasal insert adjacent the base end, the inspiratory diaphragm permitting passage of inhaled air from outside said nasal insert, through the inspiratory diaphragm, and into said nasal insert, but preventing passage of exhaled air through the inspiratory diaphragm and out of said nasal insert;

(e) a removable filter disposed over said inspiratory diaphragm; and

(f) means for retaining said filter;

wherein said nasal insert is capable of being compressed and inserted into the patient'"'"'s naris to a patient'"'"'s mucosal membrane and being retained therein solely by said flange and by the resilience of said nasal insert, said inspiratory diaphragm being disposed below the patient'"'"'s naris.