Ventilator for Rapid Response to Respiratory Disease Conditions

• US 20100306992A1
• Filed: 02/09/2010
• Published: 12/09/2010
• Est. Priority Date: 02/23/2006
• Status: Active Grant

• Current Assignee: Spacelabs Healthcare, Inc. (OSI Systems Incorporated)
• Original Assignee: Spacelabs Healthcare LLC (OSI Systems Incorporated)
• Inventors: Hays, Roy, Cooke, Richard Henry, Hinton, David Kevin, Ong, Nicolas, Hergert, Theodore Scott, Gilham, Jeffrey Jay
• Granted Patent: US 8,960,194 B2
• Time in Patent Office: Days
• US Class Current: 29/592.1
• CPC Class Codes: A61M 16/0409 with mean for closing the oesophagus
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/127 by Venturi effect, i.e. entrainment mixers
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 16/205 used for exhalation control
• CPC Class Codes: A61M 16/207 Membrane valves with pneumatic amplification stage, i.e. having master and slave membranes
• CPC Class Codes: A61M 16/209 Relief valves
• CPC Class Codes: A61M 2016/0015 inhalation detectors
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/5313 Means to assemble electrical device

Abstract

The present specification discloses a ventilator system that can be manufactured quickly with minimal skill requirements and rapidly deployed in response to epidemic respiratory disease conditions. In one embodiment, the ventilator, having a minimal number of controls, is used to give ventilation or mechanical breathing to a patient suffering ARDS. The mechanical ventilation is based on pressure control and has variable pressure, breathing rate, and oxygenation. Preferably, the ventilator is rapidly deployable, easy and intuitive to operate, and capable of sustaining at least 75% of epidemic respiratory distress victims who require assisted ventilation until resuming normal breathing.

Claims

1. A method of manufacturing a ventilator comprising the steps of:

a. Obtaining main housing, wherein the main housing comprises;

i. a first housing with internal structures formed to support enclosure of a first component set and a second component set, wherein the first housing further comprises at least one patient connection port;

ii. a second housing with internal structures formed to support enclosure of a third component set and a fourth component set, wherein the second housing further comprises an exhaust port; and

iii. a third housing with internal structures formed to support enclosure of an alarm printed circuit board (PCB);

b. Obtaining the first, second, third and fourth component sets;

c. Obtaining a printed circuit board (PCB) having an alarm circuit; and

d. Enclosing the first and second component sets in the first housing;

the third and fourth component sets in the second housing and the PCB within the third housing.

2. The method of manufacturing the ventilator of claim 1, wherein the ventilator is disposable.

3. The method of manufacturing the ventilator of claim 1, wherein ventilator is reusable.

4. The method of manufacturing the ventilator of claim 1, wherein the first, second, third and fourth component sets are molded using silicone rubber.

5. The method of manufacturing the ventilator of claim 1, wherein the main housing, the first, second, third and fourth component sets and the PCB are created using a kit comprising:

a. CAD files defining a plurality of molds for casting the main housing and the first, second, third and fourth component sets;

b. material sources and specifications for the castings,

c. a printed circuit board comprising an alarm circuit; and

d. a lithium battery.

6. The method of manufacturing the ventilator of claim 1, wherein the main housing, the first, second, third and fourth component sets, and the PCB are created using a kit comprising:

a. molds for casting the main housing and the first, second, third and fourth component sets;

b. material sources and specifications for the castings,

c. a printed circuit board having an alarm circuit, and

d. a lithium battery.

7. The method of manufacturing the ventilator of claim 1, wherein the first, second and third housings are attached using clip-on connectors.

8. The method of manufacturing the ventilator of claim 7, wherein the clip-on connectors are integrated into the moldings such that two portions of the components or housing overlap to at least a minimum area and have at least one feature that engages within the overlapping edges.

9. The method of manufacturing the ventilator of claim 8, wherein the at least one feature includes grooves.

10. The method of manufacturing the ventilator of claim 1 further comprising the step of testing the ventilator.

11. The method of claim 10 wherein the testing step comprises:

a. applying a pressurized gas to the ventilator;

b. performing a leak test to ensure that the gas supply connections are free of leaks; and

c. performing a functional test to verify operability of the ventilator.

12. The method of claim 11, wherein said step of applying a pressurized gas to the ventilator comprises connecting a conventional medical device oxygen hose to both a standard threaded male connector formed within the molding and an oxygen supply ranging from 280 kPa to 450 kPa.

13. The method of claim 11, wherein said step of performing a leak test comprises pressurizing the ventilator with the outlet occluded or blocked, increasing the oxygen pressure, turning off the oxygen supply, and monitoring the pressure for approximately one minute.

14. The method of claim 11, wherein the functional test comprises connecting, via a monitoring test fixture, ventilator outlets to a patient circuit and a test lung of C20, R20;

applying a gas pressure such that the ventilator begins to run; and

comparing displayed parameters to readings on the test fixture.

15. The method of claim 14 wherein a go/no go indicator is employed to ensure product safety.

16. A kit for manufacturing a ventilator comprising:

a. A first housing with internal structures formed to support enclosure of a first component set and a second component set, wherein the first housing further comprises at least one patient connection port;

b. A second housing with internal structures formed to support enclosure of a third component set and a fourth component set, wherein the second housing further comprises an exhaust port; and

c. A third housing with internal structures formed to support enclosure of an alarm printed circuit board (PCB); and

d. A printed circuit board (PCB) having an alarm circuit.

17. The kit of claim 16 further comprising the first, second, third and fourth component sets.

18. The kit of claim 16, wherein the ventilator is disposable.

19. The kit of claim 16, wherein the first, second, third and fourth component sets are molded using silicone rubber.

20. The kit of claim 16 further comprising

a. CAD files defining a plurality of molds for casting the first, second, third and fourth component sets;

b. material sources and specifications for the castings; and

c. a lithium battery.