U.S. patent application number 11/545281 was filed with the patent office on 2007-03-29 for respiratory monitoring, diagnostic and therapeutic system.
Invention is credited to Leo R. JR. Roucher, Jeffery D. Schipper, Ross Tsukashima, Erich H. Wolf.
Application Number | 20070068811 11/545281 |
Document ID | / |
Family ID | 34657409 |
Filed Date | 2007-03-29 |
United States Patent
Application |
20070068811 |
Kind Code |
A1 |
Tsukashima; Ross ; et
al. |
March 29, 2007 |
Respiratory monitoring, diagnostic and therapeutic system
Abstract
Disclosed is a system and method for monitoring, diagnosing, and
treating certain respiratory conditions, such as asthma. The system
includes a mask apparatus fitted with a pH sensor and thermocouple,
a continuous positive airway pressure (CPAP) device, a processing
receiver, and a therapeutic nebulizer/atomizer/humidifier device.
The mask apparatus, CPAP device and therapeutic
nebulizer/atomizer/humidifier device are connected by a pneumatic
means. The pH sensor and the thermocouple are in electrical
communication with the processing receiver that controls, through
an electronic means, the CPAP device and therapeutic
nebulizer/atomizer/humidifier device. The electrical communications
can be in the form of a plurality of wires or employ wireless
means.
Inventors: |
Tsukashima; Ross; (San
Diego, CA) ; Schipper; Jeffery D.; (Ramona, CA)
; Roucher; Leo R. JR.; (Rancho Santa Fe, CA) ;
Wolf; Erich H.; (Vista, CA) |
Correspondence
Address: |
MICHAEL E. KLICPERA
PO BOX 573
LA JOLLA
CA
92038-0573
US
|
Family ID: |
34657409 |
Appl. No.: |
11/545281 |
Filed: |
October 10, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10693115 |
Oct 24, 2003 |
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11545281 |
Oct 10, 2006 |
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10725920 |
Dec 1, 2003 |
7166201 |
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11545281 |
Oct 10, 2006 |
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10823941 |
Apr 14, 2004 |
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11545281 |
Oct 10, 2006 |
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Current U.S.
Class: |
204/433 |
Current CPC
Class: |
G01N 33/497 20130101;
A61B 5/083 20130101; A61B 5/08 20130101; A61B 5/682 20130101; A61B
5/14539 20130101; A61B 5/082 20130101 |
Class at
Publication: |
204/433 |
International
Class: |
G01N 27/26 20060101
G01N027/26 |
Claims
1. A system for monitoring a respiratory condition: an apparatus
for exposing a sensor to an individual's breath; a processing
receiver; and said sensor providing a continuous real-time
communication indicative of a parameter of said individual's
breath.
2. The system as recited in claim 1, wherein said apparatus is a
general mask.
3. The system as recited in claim 1, wherein said sensor is
designed to monitor pH.
4. The system as recited in claim 1, wherein said respiratory
condition is asthma.
5. The system as recited in claim 1, wherein said communication is
accomplished by a plurality of wires.
6. The system as recited in claim 1, wherein said communication is
accomplished by a wireless means.
7. The system as recited in claim 1, wherein said apparatus
includes a means to condense the individual's breath to form a
liquid pool in close proximity to said sensor.
8. The system as recited in claim 7, wherein said apparatus has a
means to continuously circulate and replace said sample of
liquefied breath with a fresh sample of liquefied condensed
breath.
9. A system for monitoring and diagnosing a respiratory condition:
an apparatus for exposing a sensor to an individual's breath; a
processing receiver; said sensor providing a continuous real-time
communication indicative of a parameter of said individual's
breath; said sensor in communication with said receiver; and said
processing receiver processing said information for determining
various diagnoses.
10. The system as recited in claim 9, wherein said apparatus is a
general mask.
11. The system as recited in claim 9, wherein said respiratory
condition is asthma.
12. The system as recited in claim 9, wherein said communication is
accomplished by a plurality of wires.
13. The system as recited in claim 9, wherein said communication is
accomplished by a wireless means.
14. The system as recited in claim 9, wherein said sensor is
designed to monitor pH.
15. The system as recited in claim 9, wherein said apparatus
includes a means to condense the individual's breath to form a
liquid pool in close proximity to said sensor.
16. The system as recited in claim 15, wherein said apparatus has a
means to continuously circulate and replace said sample of
liquefied breath with a fresh sample of liquefied condensed
breath.
17. A system for monitoring, diagnosing, and treating a respiratory
condition: an apparatus for exposing a sensor to an individual's
breath; a processing receiver; said sensor providing a continuous
real-time communication indicative of a parameter of said
individual's breath; said sensor in a first real-time communication
with said receiver; said processing receiver processing said
information for determining various diagnoses and treatments; and
said processing receiver in a second communication with at least
one treatment device to administer at least one therapeutic
dose.
18. The system as recited in claim 17, wherein said apparatus is a
general mask.
19. The system as recited in claim 17, wherein said respiratory
condition is asthma.
20. The system as recited in claim 17, wherein said first
communication is accomplished by a plurality of wires.
21. The system as recited in claim 17, wherein said first
communication is accomplished by a wireless means.
22. The system as recited in claim 17, wherein said second
communication is accomplished by a plurality of wires.
23. The system as recited in claim 17, wherein said second
communication is accomplished by a wireless means.
24. The system as recited in claim 17, wherein said sensor is
designed to monitor pH.
25. The system as recited in claim 17, wherein said treatment is a
biocompatible agent capable of neutralizing an acidic
condition.
26. The system as recited in claim 17, wherein said treatment is
sodium bicarbonate.
27. The system as recited in claim 17, further comprising a
communication between said processing receiver and a
nebulizer/atomizer/humidifier.
28. The system as recited in claim 17, further comprising a third
communication between said processing receiver and a continuous
positive airway pressure device.
29. The system as recited in claim 17, wherein said apparatus
includes a means to condense the individual's breath to form a
liquid pool in close proximity to said sensor.
30. The system as recited in claim 29, wherein said apparatus has a
means to continuously circulate and replace said sample of
liquefied breath with a fresh sample of liquefied condensed
breath.
31. An apparatus for monitoring breath chemistry comprising: a
sensor; a solid-state cooling means, said cooling means in physical
engagement with said sensor; a collection pool; said cooling means
reducing the temperature of said sensor below the dew point of a
patient's breath such that the patient's breath condenses into a
liquid that fills said collection pool; and said sensor immersed in
said liquefied breath in said collection pool.
32. An apparatus as recited in claim 31, further comprising an exit
means to expel and replenish said collection pool with fresh
liquefied patient's breath condensate.
33. A method of monitoring a respiratory condition: monitoring a
chemical parameter of a patient's breath with a sensor; and
communicating said chemical parameter in real-time under a sampling
frequency from said sensor to a computing receiver.
34. A method of monitoring and diagnosing a respiratory condition:
monitoring a chemical parameter of a patient's breath with a
self-condensing sensor; communicating said chemical parameter in
real-time under a sampling frequency from said sensor to a
computing receiver; and processing said chemical parameter
information by a computing receiver to diagnose a patients' breath
chemistry.
35. A method of monitoring, diagnosing and treating a respiratory
condition: monitoring a chemical parameter of a patient's breath
with a sensor; communicating said chemical parameter in real-time
under a sampling frequency from said sensor to a computing
receiver; processing said chemical parameter information by a
computing receiver to diagnose a patients' breath chemistry.
performing a function on the occurrence of a threshold level; and
communicating with a treatment nebulizer/atomizer/humidifier such
that when the chemical parameter threshold level is reached, said
computing receiver instructs said treatment
nebulizer/atomizer/humidifier to dispense one or more
medicaments.
36. A method of monitoring a respiratory condition: exposing a
sensor to an environment that assesses a chemical parameter of the
breath of a patient; transferring in real-time said chemical
parameter information to a processing receiver; and converting the
chemical parameter information communicated to the processing
receiver to a digitized format.
37. A method of monitoring and diagnosing a respiratory condition:
exposing a sensor to an environment that assesses a chemical
parameter of the breath of a patient; transferring in real-time
said chemical parameter information to a processing receiver; and
converting the chemical parameter information communicated to the
processing receiver to a digitized format to diagnose said chemical
parameter information.
38. A method of monitoring, diagnosing and treating a respiratory
condition: exposing a sensor to an environment that assesses a
chemical parameter of the breath of a patient; transferring in
real-time said chemical parameter information to a processing
receiver; converting the chemical parameter information
communicated to the processing receiver to a digitized format to
diagnose said chemical parameter information; and processing said
chemical parameter information for determining various treatments.
Description
CROSS-REFERENCES
[0001] The present application is a continuation-in-part of patent
application Ser. No. 10/693,115 filed on Oct. 24, 2003 entitled "A
Respiratory Monitoring, Diagnostic and Therapeutic System"
currently pending and a continuation-in-part of patent application
Ser. No. 10/725,920 filed on Dec. 1, 2003 and patent application
Ser. No. 10/823,941 filed on Apr. 14, 2004 both entitled "A
Self-Condensing pH Sensor". These applications are incorporated
herein by this reference.
FIELD OF THE INVENTION
[0002] The field of art to which this invention relates is in the
monitoring of certain parameters and transfer of such information
to facilitate therapeutic treatment for patients suffering from
respiratory diseases, such as asthma. More specifically, the
present invention monitors the pH level of a patient's breath and
provides data for determining the frequency and volume of a
therapeutic dose to be administered to the asthmatics' airways.
BACKGROUND OF THE INVENTION
[0003] Recently, it has been reported that the monitoring of
acidity or pH of a patient's breath could help physicians in
estimating the degree of air passage inflammation in the lungs, now
considered a key contributor to asthma and other respiratory
conditions. Asthma is characterized by symptoms of wheezing,
coughing, chest tightness, and shortness of breath. Manifestations
include constriction (the tightening of the muscles around the
airways) and inflammation (the swelling and irritation of the
airways) that can be triggered through exposure to smoking, dust
mites, pets, activity, cold, infection, weather, pollen, etc.
[0004] A clinical study of people with chronic obstructive
pulmonary disease (COPD), bronchiectasis and asthma demonstrated
more acidic levels in COPD and bronchiectasis patients, which is
indicative of the chronic inflammation that these patients
experience. This study also observed an increase acidic level
measured from the breath of patients suffering from moderate asthma
when compared to mild forms of the disease. It was also found that
the asthmatics' breath was much more acidic during asthma attacks,
but normalized after anti-inflammatory medication was
administered.
[0005] This data suggests that the monitoring of an asthmatics'
breath for pH might be an effective way to measure the degree of
inflammation in the air passages. Furthermore, this data suggests
that close monitoring of an asthmatic's breath pH could lead to
prompt and effective treatment, minimizing the occurrence of asthma
attacks and provide overall better management.
[0006] It is estimated that 18-26 million people in the United
Stated suffer from asthmatic conditions. It is also believed that
over 5.6 million of these asthma suffers are under the age of 18,
ranking this disease as the 8.sup.th worst chronic condition.
[0007] Studies have also shown that gastro-esophageal reflux
disease (GERD) induced asthma affects approximately 40% of the US
Adult Population and that 60-80 percent of all asthma patients have
GERD. Gastro-esophageal reflux is a condition in which gastric acid
refluxes from the stomach and into the esophagus. Frequent reflux
episodes may result in a potentially severe problem known as
gastro-esophageal reflux disease. GERD is the most common cause of
dyspepsia or heartburn. GERD can also manifest in the
micro-aspiration of acid from the esophagus and into the lungs,
damaging tissue, and causing swelling and irritation of the vagus
nerve. This irritation of the vagus nerve, which is common to both
the esophagus and the bronchial tree, causes constriction of the
airways. Acid refluxes past the lower esophageal sphincter and
causes anatomical damage, sleep disordered breathing, and dietary
affects. It has also been found that bronchial dilators can relax
the lower esophageal sphincter and trigger GERD induced asthmatic
conditions. Sleep apnea has also been found to trigger reflux
events.
[0008] Current pH monitoring suffers from the following drawbacks,
1) invasive procedure, 2) not well tolerated by some patients, 3)
catheter or capsule placement must be performed by a physician, 4)
capsule cannot be placed above the Upper Esophageal Sphincter (UES)
and 5) there are no defined standards (DeMeester Score) for UES
evaluation.
[0009] Accordingly, there is a need in this art for a novel, pH
monitoring mask with electronic or wireless communication linked to
a processing receiver that activates a therapeutic
nebulizer/atomizer/humidifier for treating asthmatic or other
respiratory conditions.
SUMMARY OF THE INVENTION
[0010] The present invention pertains to an invention for
monitoring the pH level of a patient's breath in a typical mask and
provides a means for transferring this data to a processing
receiver for diagnosing and determining the frequency and volume of
a therapeutic dose to be administered to a patient with a
respiratory condition such as asthma. Monitoring of a patients'
breath chemistry is provided by a system that includes a
miniaturized pH sensor, provides for real-time monitoring of
patient airway pH values, and utilizes solid state cooling to
precipitate moisture from a patient's breath.
[0011] A general respiratory mask is mounted with a miniaturized pH
sensor and data transfer means e.g. direct wiring or by providing a
transmitter with an antenna for wireless transferring of the pH
data to a processing receiver. The temperature of the pH sensor is
lowered below the dew point of the exhaled patient breath by a
solid-state Peltier junction engaged on one side to a heat sink. A
thermocouple is provided to monitor the temperature of the sensor
for more accurate pH calculations. Keeping the sensor temperature
below the dew point will cause the patient's exhaled breath to
condense as a liquid in close proximity to the surface of the
sensor. It is commonly known that monitoring of pH is significantly
more accurate if measuring a condensed liquid. A transmitter with
an antenna transfers the observed pH data by employing one of many
wireless methods, such as radio-frequency (RF) energy. Alternately,
the transfer of observed pH data is accomplished by direct wire
methods.
[0012] The pH data is transferred or updated at specific intervals,
which can be varied according to the patient's needs, to the
processing receiver that is engaged to the treatment and humidifier
apparatuses. The processing receiver computes and diagnoses the
chemistry data and determines what apparatus and at what frequency
it should be activated.
[0013] The present invention mask is also fitted with a means to
remove the condensed liquid through an exhaust port or the
connected pneumatic hose to remove unnecessary and accumulated
breath condensate.
[0014] These and other features, aspects and advantages of the
present invention will become better understood with reference to
the following descriptions and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a perspective representation of the present
invention systems, showing the various components of the system,
including a mask apparatus fitted with a heat sink and pH sensing
means, a continuous positive airway pressure (CPAP) device
connected to the mask apparatus, a processing receiver electrically
connected to the mask apparatus, and a
nebulizer/atomizer/humidifier device electrically connected to the
processing receiver.
[0016] FIG. 2 is a sectional side view of the general mask
apparatus demonstrating in more detail of the orientation and
components of the mask, and pH sensing means.
[0017] FIG. 3 is a sectional view taken from FIG. 1 demonstrating
the general location of the pH sensor, cooling shank, thermocouple
and fluid pool on the sampling plate for condensing and containing
a patient's breath.
[0018] FIG. 4 is a sectional side view taken from FIG. 2
demonstrating in more detail the relative locations of the heat
sink, Peltier junction, body and head of cooling transfer shank,
thermocouple, and pH sensor.
[0019] FIG. 5 is a schematic representation of the treatment
nebulizer/atomizer/humidifier device, demonstrating a base unit
having an on/off switch, operating lights, a medicament storage
container, and interconnection for attaching the pneumatic
hose.
[0020] FIG. 6 is an electrical schematic of the general components
in the processing receiver.
[0021] FIGS. 7 and 8 are flowcharts showing the sequential
computational steps employed by the processing receiver.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0022] The present invention provides a system and method for
monitoring physiological parameters from a patient's exhaled breath
and communicates this information to a processing computer/receiver
that diagnoses the information. The system can use computational
instructions to activate and de-activate an electrically connected
treatment nebulizer/atomizer/humidifier device, and can be
integrated with a continuous positive airway pressure (CPAP)
device.
[0023] FIG. 1 illustrates that the present invention is a system 10
comprised of several components. As shown in the Figure, a typical
mask apparatus 36 is fitted with a securing strap or typical
headgear apparatus 38. The typical mask apparatus 36 is generally
fabricated from a polymeric and/or silicone material and configured
to fit over a patient's nose, or nose and mouth, to assist in
breathing conditions. The securing strap 38 is made from a flexible
material and is positioned around the patient's head such that the
mask substantially engages the patient's face and mouth area,
minimizing ambient air from entering the boundaries of the mask. It
is contemplated by the Applicants that other mask configurations
and types can be employed with the present invention to achieve the
goal of monitoring, diagnosing and treating respiratory conditions
in patients.
[0024] Shown attached to the front of the typical mask apparatus 36
is a heat sink 34 with made generally from a material that has good
heat conduction properties, such as certain metallic elements and
alloys. Some candidates for the heat sink 34 and fins 35 are
aluminum, copper, silver and gold. The heat sink 34 is fitted with
fins 35 to increase the surface area of the heat sink 34 to
dispense heat generated by the system. The heat sink 34 is shown
secured to the mask by screws 37 but can also be attached with
other commonly known methods, such as adhesives.
[0025] The typical mask apparatus 36 is connected to the exit port
22 of a CPAP device 16 by means of a pneumatic hose 18. The hose
can be manufactured from a variety of materials, including polymers
such as polyethylene, polypropylene, polyvinyl chloride or
silicone. The material used for the hose should be resistant to
water and acidic environments, and should not interfere or interact
with any medicaments employed in the present invention. CPAP air
exits port 22 and travels along the length of the pneumatic host 18
to the internal sampling cavity created by the general mask
apparatus covering the patient's face. The CPAP device has a
control means 20 for increasing and decreasing the volume of air
generated by the apparatus and the output an optional
humidification device. The CPAP device and humidifier are powered
by an electrical source such as a standard plug 12 and cable
14.
[0026] Shown connected to the heat sink 34 is an electrical wire 29
that communicates with a processing receiver 26.
[0027] Electrical wire 29 is typical in that the internal core
comprises an electrical conductive metallic material and is encased
by a nonconductive jacket. Processing receiver 26 is connected to
the CPAP device 16 by an electrical wire 24 for controlling the
activation of air generated by the CPAP device 16 and transferred
to the typical mask apparatus 36. Also, an electrical connection by
means of a wire 31 to the processing receiver 26 is a treatment
nebulizer/atomizer/humidifier device 32. As an alternate method, a
wireless means 40 can be utilized instead to communicate between
the processing receiver 26 with an antenna 28 to the treatment
nebulizer/atomizer/humidifier device 32. Although not shown in
detail in FIG. 1, a wireless means also can be employed to
communicate between the typical mask apparatus 36 and the
processing receiver 26. In addition, a wireless means also can be
employed to communicate between the processing receiver 26 and the
CPAP device 16. As appreciated by those skilled in the art,
wireless means for communicating between various components can be
accomplished using radio frequency waves, microwaves, ultrasonic
waves, or light optics.
[0028] The treatment nebulizer/atomizer/humidifier device 32 is
pneumatically connected to hose 18 at some point along its length
between the CPAP device 16 and the typical mask apparatus 36. The
treatment nebulizer/atomizer/humidifier device 32 has a medicament
storage chamber 33 where various types of therapeutic medicaments
can be delivered to the pneumatic system and to the patient at
intervals commanded by the processing receiver 26.
[0029] FIG. 2 illustrates a sectional side view of the general mask
apparatus demonstrating in more detail the orientation and
components of the mask 36, the heat sink 34 and the pH sensing
means 46. When deployed, the mask forms a sampling chamber 39
between the mask 36 and the patient's facial area that is in
pneumatic connection with the patient's respiratory system. This
sampling chamber 39 contains a current sample of the patient's
breath that enters, through a one-way valve 42, and into the
condensing chamber 41 formed between the exterior mask surface and
the back surface of the heat sink apparatus. The heat sink is
mounted to the mask apparatus 36 by screws 37 or alternatively
using adhesive or other mounting technology.
[0030] FIG. 3 is a sectional view taken from FIG. 1 demonstrating
the general location of the pH sensor, cooling shank, thermocouple
and fluid pool on the sampling plate for condensing and containing
a patient's breath. The sampling plate 43 functions to condense the
patient's breath and form a pool of liquefied breath such that the
sensor is immersed in liquid and monitors the pH level. The
sampling plate 43 is generally manufactured from a material that
has good heat conduction properties, such as certain metallic
elements and alloys. Some candidates are aluminum, copper, silver
and gold. FIG. 3 shows the general location of the pH sensor 46,
cooling shank head 56, thermocouple 52 and fluid pool area 58 for
containing condensed breath. The pH sensor 46 is comprised from a
metallic antimony or similar alloy that is fitted with a plurality
of wires or wireless means to communicate the analog pH information
monitored by the sensor to a processing receiver 26. Similarly, the
thermocouple is fabricated from standard metallic components and is
fitted with a plurality of wires or wireless means to communicate
the analog temperature information monitored by the thermocouple to
the processing receiver 26. The cooling shank head 56 is part of a
cooling shank that penetrates the sampling plate 43 and ultimately
engages the Peltier junction 50 (see FIG. 4). The cooling head 56
and body shank 54 (see FIG. 4) is fabricated generally from a
material that has good heat conduction properties, such as certain
metallic elements and alloys. Some candidates are aluminum, copper,
silver and gold. The cooling head 56 is engaged to and reduces the
temperature of the sampling plate 43 and pooling area 58 to
facilitate the condensation of breath into a liquid that pools in
the pooling area 58 that covers and becomes exposed to the pH
sensor 46. Shown here, both the thermocouple 52 and the pH sensor
46 are mounted within a lumen formed within the cooling shank head
56. The thermocouple 52 is shown residing within the cooling shank
head 56. The pH sensor extends beyond the cooling head 56 and into
the pooling area 58. The Applicant contemplates that other mounting
positions for the thermocouple 52 and pH sensor 46 can be employed
without sacrificing any performance. For example, the sensor 46 can
be mounted such that the head of the sensor enters the pooling area
from the bottom and extends back through the back side of the
sampling plate 43, as shown in FIG. 4. If appropriate, holes 45 in
sampling plate 43 can be threaded to receive screws 37.
[0031] Within the collection region 47, the pooling area 58 shown
in FIG. 3 portrays a dumbbell shape. It is contemplated by the
Applicant that various other shapes, side curvatures and dimensions
may be employed to facilitate capturing the condensed breath and
forming a pool of liquid that immerses the head of the pH sensor
46.
[0032] FIG. 4 illustrates a sectional side view taken from FIG. 1
demonstrating in more detail the relative locations of the heat
sink 34, the solid-state Peltier junction 50, body 54 and head 56
of cooling transfer shank, thermocouple 52, and pH sensor 46. As
shown in this figure, the Peltier junction 50 engages the backside
of heat sink 34. The Peltier junction 50 is connected by wires 51
to a DC power source, such as a battery (not shown) that generally
is in the range of 0.5 to 12 volts. The Peltier junction functions
as a heat pump, removing heat from the cooling body shank 54 and
head 56, thereby reducing its relative temperature, and
transferring the heat to the heat sink 34 and fins 35 that
dissipates it into the environment. As the Peltier junction reduces
the temperature of the cooling head and associated components, the
adjoining pooling area 58 and sampling plate 43 temperatures are
also reduced. The net effect of this operation is that the these
metallic surfaces have a temperature lower than the dew point,
which causes the sampled breath to condense and form a pool of
liquefied breath in the pooling area 58.
[0033] Electronic communication from the pH sensor wires 48 and the
thermocouple wires 49 that are further connected to a wire or
wireless means for communication to the processing receiver 26. In
the case of a wireless means, wires 48 and 49 would terminate in an
antenna (not shown) and communicate with an antenna associated with
the processing receiver 26.
[0034] Alternatively, a non-liquid pH sensing means, by which a
direct pH measurement of non-condensed breath may be utilized, is
contemplated by the Applicants.
[0035] FIG. 5 is a schematic representation of the treatment
nebulizer/atomizer/humidifier device 32, demonstrating a base unit
having a on/off switch 102, operating lights 104, a medicament
chamber 33, and interconnection 108 for attaching to the pneumatic
hose 18. The treatment nebulizer/atomizer/humidifier device 32 has
an outer shell surrounding various mechanical and electrical
components that function to deliver the therapeutic dose. The shell
can be made of a variety of materials, including plastics such as
polyethylene, polystyrene, ABS, nylon, delrin, or polyethylene
terephthalate (PET). The treatment nebulizer/atomizer/humidifier
device 32 communicates with the processing receiver by direct
wiring (not shown) or by use of wireless means employing an antenna
means 110. The base unit and various components of the treatment
nebulizer/atomizer/humidifier can be fabricated from polymeric or
metallic materials. Operating light 104 can consist of LED, LCD,
fluorescent, or halide or other means to communicate such
conditions, as on/off, medicament chamber empty, etc. Also, the
Applicant contemplates a plurality of operating lights can be
employed having different functions. The art associated with
atomization of particles and humidification processes are known in
the art. Many commercially available units can satisfy the basic
requirements for the treatment nebulizer/atomizer/humidifier device
32. One such device is the MicroAir portable ultrasonic nebulizer
manufactured by Omron Healthcare, Inc. of Vernon Hills, Ill. This
device can be modified or fabricated so that 1) it can be remotely
activated by the processing receiver 26, and 2) adapted to connect
to the pneumatic tube by an appropriate connection 108 as shown in
FIG. 5.
[0036] The medicament chamber 33 can contain liquid, gaseous or
powdered therapeutics that the treatment
nebulizer/atomizer/humidifier device 32 is designed to administer
to the pneumatic system upon instructions from the processing
receiver 26. It is contemplated that the medicament chamber 33
could include a plurality of medicaments in various compartments in
the medicament chamber 33. It is also contemplated that treatment
nebulizer/atomizer/humidifier device 32 can select to administer
one or more, or in a combination, multiple medicaments stored in
the medicament chamber 33.
[0037] FIG. 6 is a simplified electrical schematic of the general
components in the processing receiver 26. In the center is the
microprocessor 70 that processes the information supplied by the
thermocouple and sensor and use internal instructions to control
other devices. The microprocessor has an EEPROM memory section that
allows for specific programming to be incorporated as processing
instructions. Furthermore, the microprocessor must have the
capability to convert analog signals into digital information for
decoding and processing. An example of a microprocessor that could
be used in the processing receiver 26 is the PIC16F876 28-pin 8-Bin
CMOS FLASH micro-controllers manufactured by Microchip Technology,
Inc. This particular microprocessor has a 128K EEPROM Data memory
bank for flash memory of specific instructions and utilizes a
35-word instruction set. It also has five 10-bit Analog-to-Digital
Inputs that are necessary for converting the information obtained
from the pH sensor 46 and thermocouple 52 from its analog format
into a digitized form for processing by the instruction sets of the
microprocessor 70.
[0038] The microprocessor 70 includes a timing crystal 72 used for
clocking operations and is connected to and energized by an
approximate 12 volt power supply 69. Also included in the circuit
is a power transistor 66 with an electrical connection to the
12-volt power supply, a 5-volt regulator 68, and a ground 78.
[0039] The sensor analog data that is communicated either through
direct wiring or through a wireless means that is then amplified by
a circuit 74 and connected to the microprocessor 70 through one of
the analog-to-digital modules.
[0040] In addition, the thermocouple analog data that is
communicated either through direct wiring or through a wireless
means that is amplified by circuit 76 and connected to the
microprocessor 70 through another one of the analog-to-digital
modules.
[0041] In certain embodiments, the transmitted data can be
recorded, compressed and stored as it is received using a memory
chip set or memory circuit within the microprocessor (not shown).
Subsequently, the data stored can be downloaded into an external
data retrieval device, which can be a computer or other analysis
machine.
[0042] FIGS. 7 and 8 illustrate flowcharts showing the sequential
computational steps employed by the processing receiver 26. As
described above, the microprocessor 70 has an EEPROM memory section
that allows for specific programming to be incorporated as
processing instructions. The steps programmed in the microprocessor
70 are outlined in the flowcharts, starting with the 1) monitoring
of breath chemistry 120 without CPAP support (FIG. 7) 2) the
monitoring of breath chemistry and breathing rates (122) when CPAP
supported (FIG. 8). The analog information obtained from the sensor
and the thermocouple is converted to digital information and
transferred to the microprocessor. The microprocessor uses the
thermocouple data to calculate an accurate pH level that is stored
in a registry. Optionally, this data can be diagnosed by the
microprocessor 140 and stored in a memory bank whereby the
microprocessor can create diagnostic reports 150.
[0043] The stored data is then compared to a threshold value or
range 160 programmed in the instruction set of the microprocessor
70. For example, if the pH level does not reach the threshold
value, then no actions are performed and the instruction set loops
back to read breath chemistry (FIG. 7) or breath chemistry and
monitor breathing rates (FIG. 8). If the pH level reaches the
threshold value, then the microprocessor 70 determines the
appropriate therapy 170.
[0044] These computational steps can be continued over and over
again to detect, record, analyze and administer the appropriate
therapeutic regime to manage patients with certain respiratory
conditions.
[0045] The present invention will: 1) Monitor; 2) Diagnose; 3)
Treat a respiratory disease, with and without CPAP therapy.
[0046] While the invention has been described in detail and with
reference to specific embodiment thereof, it will be apparent to
one skilled in the art that various changes and modifications can
be made therein without departing from the spirit and scope
thereof.
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