U.S. patent application number 10/695436 was filed with the patent office on 2004-08-19 for control of respiratory oxygen delivery.
This patent application is currently assigned to Minnesota Innovative Technologies and Instruments, Minnesota Innovative Technologies and Instruments. Invention is credited to Buan, John S., Nordman, Catherine A., Schmidt, Matthew F..
Application Number | 20040159323 10/695436 |
Document ID | / |
Family ID | 23840713 |
Filed Date | 2004-08-19 |
United States Patent
Application |
20040159323 |
Kind Code |
A1 |
Schmidt, Matthew F. ; et
al. |
August 19, 2004 |
Control of respiratory oxygen delivery
Abstract
Methods and systems for supplying respiratory oxygen to users
when the users are inhaling are disclosed. The methods and systems
may rely on delivery devices that are selectively placed in fluid
communication with either a respiration sensor or a source of
oxygen. The methods and systems may actively monitor for
exhalations, as well as monitor for oxygen in the oxygen source.
The respiration sensor may preferably be a flow sensor.
Inventors: |
Schmidt, Matthew F.; (Lino
Lakes, MN) ; Buan, John S.; (Maple Grove, MN)
; Nordman, Catherine A.; (St. Paul, MN) |
Correspondence
Address: |
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581415
MINNEAPOLIS
MN
55458
US
|
Assignee: |
Minnesota Innovative Technologies
and Instruments
Lino Lakes
MN
|
Family ID: |
23840713 |
Appl. No.: |
10/695436 |
Filed: |
October 28, 2003 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10695436 |
Oct 28, 2003 |
|
|
|
10370799 |
Feb 20, 2003 |
|
|
|
10370799 |
Feb 20, 2003 |
|
|
|
10076001 |
Feb 14, 2002 |
|
|
|
6561187 |
|
|
|
|
10076001 |
Feb 14, 2002 |
|
|
|
09463614 |
May 8, 2000 |
|
|
|
6371114 |
|
|
|
|
09463614 |
May 8, 2000 |
|
|
|
PCT/US98/15490 |
Jul 24, 1998 |
|
|
|
09463614 |
May 8, 2000 |
|
|
|
08900686 |
Jul 25, 1997 |
|
|
|
6532958 |
|
|
|
|
60064578 |
Nov 4, 1997 |
|
|
|
Current U.S.
Class: |
128/204.23 ;
128/204.18 |
Current CPC
Class: |
A61M 2202/0007 20130101;
A61M 2016/0024 20130101; A61M 16/0051 20130101; A61M 2205/3561
20130101; A61M 2230/205 20130101; A61M 2230/63 20130101; A61M
2202/03 20130101; A61M 16/026 20170801; A61M 2202/0208 20130101;
A61M 16/0677 20140204; A61M 16/101 20140204; A61M 2202/0208
20130101; A61M 2016/0027 20130101; A61M 2016/0021 20130101 |
Class at
Publication: |
128/204.23 ;
128/204.18 |
International
Class: |
A61M 016/00 |
Claims
1. A portable oxygen delivery control apparatus for controlling a
flow of oxygen to a user in an open-loop breathing system including
an oxygen supply and a delivery apparatus for delivering
supplemental oxygen to a user comprising: an oximeter arranged to
measure a blood-oxygen saturation level of a user and provide an
output signal indicative of said blood-oxygen saturation level; a
valve, a first port of said valve adapted to be connected to said
oxygen supply and a second port adapted to be connected to said
delivery apparatus, said valve having a first position permitting
oxygen to flow from said supply to said delivery apparatus, and a
second position preventing oxygen from flowing from said supply to
said delivery apparatus; a pressure sensor, said sensor associated
with a said valve, said sensor arranged to detect a period of
inhalation by said user by detecting a condition of reduced
pressure associated with said delivery apparatus for delivering
supplemental oxygen to a user when said valve is in said second
position; a selector adapted to accept a target blood-oxygen
saturation level; a flow sensor, said flow sensor positioned along
a flow path between said oxygen supply and said delivery apparatus,
said flow sensor configured to generate information regarding a
flow rate of oxygen delivered from said oxygen supply to said user;
and a processor arranged to calculate a time period which said
valve should be maintained in its first position to cause a desired
amount of oxygen to be delivered to said user when said oximeter
indicates a blood-oxygen saturation level which is below said goal
blood-oxygen saturation level and arranged to generate a signal for
said time period, which signal applied to said valve moves said
valve to said first position and causes oxygen to be delivered to
said user when a condition of inhalation is detected by said
pressure sensor, and said signal when removed from said valve
causes said valve to be moved to said second position.
2. The apparatus in accordance with claim 1 including a memory
associated with said processor, said memory configured to store
flow rate information.
3. The apparatus in accordance with claim 1 wherein said processor,
flow sensor, valve and pressure sensor are associated with said
processor and said selector comprises a user-actuatable input.
4. The apparatus in accordance with claim 1 wherein said pressure
sensor comprises a diaphragm exposed to the atmosphere on opposing
sides so as to be altitude correcting.
5. A method of controlling a flow of supplemental oxygen from an
oxygen supply to a user through a delivery apparatus in an
open-loop breathing system, the delivery apparatus including a
valve moveable between a first position permitting oxygen to flow
from said supply to said user and a second position for preventing
oxygen to flow from said supply to said user comprising the steps
of: receiving a goal blood-oxygen saturation level of a user;
determining an actual blood-oxygen saturation level of a user;
determining a length of time said valve should be moved to said
first position in order to deliver a desired quantity of oxygen to
achieve said goal blood-oxygen saturation level based upon said
actual blood-oxygen saturation level; detecting the initiation of
inhalation by said user; moving said valve from said second
position to said first position for said determined length of time
when said inhalation is detected; returning said valve to said
second position; and generating information regarding an average
flow rate of oxygen delivered from said supply to said user;
determining if a change in average flow rate exceeds a
predetermined amount and, if so, triggering an alarm.
6. The method in accordance with claim 5 wherein said step of
determining a blood-oxygen saturation level comprises measuring a
blood-oxygen saturation level of said user with a
pulse-oximeter.
7. The method in accordance with claim 5 wherein said step of
determining the initiation of inhalation by a user comprises
sensing a drop in pressure at said delivery apparatus.
8. The method in accordance with claim 5 wherein said predetermined
amount comprises a predetermined percentage change in average flow
rate.
9. The method in accordance with claim 5 wherein said step of
triggering an alarm comprises illuminating a light.
10. The method in accordance with claim 5 wherein said step of
triggering an alarm comprises emitting an audible noise.
11. The method in accordance with claim 5 including the step of
storing flow rate information received from said output of said
flow sensor and utilizing said stored information to generate said
average flow rate.
12. The method in accordance with claim 5 wherein said step of
generating information regarding an average flow rate comprises
generating flow rate information with a flow sensor and utilizing
said flow rate information to generate information regarding
average flow rate.
13. A method of controlling a flow of oxygen from an oxygen supply
to a user comprising the following steps: providing an amount of
oxygen to a user in a breathing system, said amount of oxygen
determined by comparing a desired blood-oxygen content level with a
measured blood-oxygen content level, said amount of oxygen
delivered to said user when a period of inhalation of said user is
detected, said amount of oxygen provided to said user continuously
automatically adjusted based upon said desired and measured
blood-oxygen content levels; and determining an average dose time,
said average dose time indicative of the average flow rate of
oxygen delivered to said user and triggering an alarm if said
average dose time changes by an amount exceeding a predetermined
amount.
14. The method in accordance with claim 13 including the step of
opening a valve to provide said amount of oxygen.
15. A method of controlling a flow of supplemental oxygen from an
oxygen supply to a user through a delivery apparatus in an
open-loop breathing system, the delivery apparatus including a
valve moveable between a first position to flow from said supply to
said user and a second position for preventing oxygen to flow from
said supply to said user, comprising the steps of: receiving a goal
blood-oxygen saturation level of a user; determining an actual
blood-oxygen saturation level of a user; determining a breath rate
of said user; sensing periods of inhalation by said user;
determining a length of time said valve should be moved to said
first position in order to deliver a desired quantity of oxygen,
said determining step comprising determining a maximum time said
valve should be moved to said first position, determining a minimum
time said valve should be moved to said first position, and
determining a variable time said valve should be moved to said
first position; detecting the initiation of inhalation by said
user; and moving said valve from said second position to said first
position for said determined length of time; and returning said
valve to said second position.
16. The method in accordance with claim 15 wherein said step of
determining a blood oxygen saturation level comprises measuring a
blood-oxygen saturation level of said user with a
pulse-oximeter.
17. The method in accordance with claim 15 wherein said step of
determining the initiation of inhalation by a user comprises
sensing a drop in pressure at said delivery apparatus.
18. The method in accordance with claim 15 wherein said desired
quantity of oxygen comprises a maximum quantity when said actual
blood-oxygen saturation level is below said goal blood-oxygen
saturation level.
19. The method in accordance with claim 15 wherein said desired
quantity of oxygen comprises a linearly changing quantity between a
minimum quantity corresponding to said minimum time and a maximum
quantity corresponding to said maximum time.
20. The method in accordance with claim 15 wherein said step of
moving said valve comprises applying a signal to said valve causing
said valve to be retained in its first position for said determined
length of time.
21. A portable oxygen delivery control apparatus for controlling a
flow of oxygen to a user in an open-loop breathing system including
an oxygen supply and a delivery apparatus for delivering
supplemental oxygen to a user comprising: an oximeter arranged to
measure a blood-oxygen saturation level of a user and provide an
output signal indicative of said blood-oxygen saturation level; a
valve, a first port of said valve adapted to be connected to said
oxygen supply and a second port adapted to be connected to said
delivery apparatus, said valve having a first position permitting
oxygen to flow from said supply to said delivery apparatus, and a
second position preventing oxygen from flowing from said supply to
said delivery apparatus; a pressure sensor, said sensor associated
with a said valve, said sensor arranged to detect a period of
inhalation by said user; a selector adapted to accept a target
blood-oxygen saturation level; an average dose time calculator
adapted to determine an amount of oxygen delivered to said user
from said oxygen supply; and a processor arranged to calculate a
dose time period which said valve should be maintained in its first
position to cause a desired amount of oxygen to be delivered to
said user when said oximeter indicates a blood-oxygen saturation
level which is below said goal blood-oxygen saturation level and
arranged to generate a signal for said dose time period, which
signal applied to said valve moves said valve to said first
position and causes oxygen to be delivered to said user when a
condition of inhalation is detected by said pressure sensor, and
said signal when removed from said valve causes said valve to be
moved to said second position, and said processor configured to
utilize average dose time information generated by said average
dose time calculator and trigger an alarm in the event said amount
of oxygen delivered to said user from said oxygen supply meets a
predetermined criteria.
22. The apparatus in accordance with claim 21 including a memory
associated with said processor, said memory configured to store
said average dose time information.
23. The apparatus in accordance with claim 21 wherein said alarm
comprises an audible warning.
24. The apparatus in accordance with claim 21 wherein said alarm
comprises a visual warning.
25. The apparatus in accordance with claim 21 wherein said
processor, flow sensor, valve and pressure sensor are associated
with a printed circuit board located within a housing and said
selector comprises a user-actuatable input extending from said
housing.
26. The apparatus in accordance with claim 21 wherein said pressure
sensor comprises a diaphragm exposed to the atmosphere on opposing
sides so as to be altitude correcting.
27. A method of controlling a flow of supplemental oxygen from an
oxygen supply to a user through a delivery apparatus in an
open-loop breathing system, the delivery apparatus including a
valve moveable between a first position permitting oxygen to flow
from said supply to said user and a second position for preventing
oxygen to flow from said supply to said user comprising the steps
of: receiving a goal blood-oxygen saturation level of a user;
determining an actual blood-oxygen saturation level of a user;
determining a length of time said valve should be moved to said
first position in order to deliver a desired quantity of oxygen to
achieve said goal blood-oxygen saturation level based upon said
actual blood-oxygen saturation level; detecting the initiation of
inhalation by said user; moving said valve from said second
position to said first position for said determined length of time
when said inhalation is detected; returning said valve to said
second position; generating information regarding an average dose
time of oxygen delivered from said supply to said user; and
determining if a change in said average dose time exceeds a
predetermined amount and, if so, triggering an alarm.
28. The method in accordance with claim 27 wherein said step of
determining a blood-oxygen saturation level comprises measuring a
blood-oxygen saturation level of said user with a
pulse-oximeter.
29. The method in accordance with claim 27 wherein said step of
determining the initiation of inhalation by a user comprises
sensing a drop in pressure at said delivery apparatus.
30. The method in accordance with claim 27 wherein said step of
triggering an alarm comprises illuminating a light.
31. The method in accordance with claim 27 wherein said step of
triggering an alarm comprises emitting an audible noise.
32. The method in accordance with claim 27 including the step of
storing current dose time information and utilizing said stored
current does time information to generate said average dose
time.
33. A portable oxygen delivery control apparatus for controlling a
flow of oxygen to a user in an open-loop breathing system including
an oxygen supply and a delivery apparatus for delivering
supplemental oxygen to a user comprising: an oximeter arranged to
measure a blood-oxygen saturation level of a user and provide an
output signal indicative of said blood-oxygen saturation level; a
valve, a first port of said valve adapted to be connected to said
oxygen supply and a second port adapted to be connected to said
delivery apparatus, said valve having a first position permitting
oxygen to flow from said supply to said delivery apparatus, and a
second position preventing oxygen from flowing from said supply to
said delivery apparatus; a pressure sensor, said sensor associated
with a said valve, said sensor including a diaphragm exposed to the
atmosphere on opposing sides so as to be altitude correcting and
arranged to detect a period of inhalation by said user by detecting
a condition of reduced pressure associated with said delivery
apparatus for delivering supplemental oxygen to a user when said
valve is in said second position; a selector adapted to accept a
target blood-oxygen saturation level; a flow sensor, said flow
sensor positioned along a flow path between said oxygen supply and
said delivery apparatus, said flow sensor configured to generate
information regarding a flow rate of oxygen delivered from said
oxygen supply to said user; and a processor arranged to calculate a
time period which said valve should be maintained in its first
position to cause a desired amount of oxygen to be delivered to
said user when said oximeter indicates a blood-oxygen saturation
level which is below said goal blood-oxygen saturation level and
arranged to generate a signal for said time period, which signal
applied to said valve moves said valve to said first position and
causes oxygen to be delivered to said user when and a condition of
inhalation is detected by said pressure sensor, and said signal
when removed from said valve causes said valve to be moved to said
second position, and said processor configured to utilize flow rate
information generated by said flow sensor and trigger an alarm in
the event said utilized flow rate information meets a predetermined
criteria.
34. The apparatus in accordance with claim 33 including a memory
associated with said processor, said memory configured to store
flow rate information.
35. The apparatus in accordance with claim 33 wherein said alarm
comprises an audible warning.
36. The apparatus in accordance with claim 33 wherein said alarm
comprises a visual warning.
37. The apparatus in accordance with claim 33 wherein said
processor, flow sensor, valve and pressure sensor are associated
with a printed circuit board located within a housing and said
selector comprises a user-actuatable input extending from said
housing.
38. A method of controlling a flow of supplemental oxygen from an
oxygen supply to a user through a delivery apparatus in an
open-loop breathing system, the delivery apparatus including a
valve moveable between a first position permitting oxygen to flow
from said supply to said user and a second position for preventing
oxygen to flow from said supply to said user comprising the steps
of: receiving a goal blood-oxygen saturation level of a user;
determining an actual blood-oxygen saturation level of a user;
determining a length of time said valve should be moved to said
first position in order to deliver a desired quantity of oxygen to
achieve said goal blood-oxygen saturation level based upon said
actual blood-oxygen saturation level; detecting the initiation of
inhalation by said user; moving said valve from said second
position to said first position for said determined length of time
when said inhalation is detected; returning said valve to said
first position; and generating at two or more times information
regarding an average flow rate of oxygen delivered from said supply
to said user; determining if a change in average flow rate exceeds
a predetermined amount and, if so, triggering an alarm.
39. The method in accordance with claim 38 wherein said step of
determining a blood-oxygen saturation level comprises measuring a
blood-oxygen saturation level of said user with a
pulse-oximeter.
40. The method in accordance with claim 38 wherein said step of
determining the initiation of inhalation by a user comprises
sensing a drop in pressure at said delivery apparatus.
41. The method in accordance with claim 38 wherein said
predetermined amount comprises a predetermined percentage change in
average flow rate.
42. The method in accordance with claim 38 wherein said step of
triggering an alarm comprises illuminating a light.
43. The method in accordance with claim 38 wherein said step of
triggering an alarm comprises emitting an audible noise.
44. The method in accordance with claim 38 including the step of
storing flow rate information received from said output of said
flow sensor and utilizing said stored information to generate said
average flow rate.
45. The method in accordance with claim 38 wherein said step of
generating information regarding an average flow rate comprises
generating flow rate information with a flow sensor and utilizing
said flow rate information to generate information regarding
average flow rate.
46. A method of controlling a flow of oxygen from an oxygen supply
to a user comprising the following steps: providing an amount of
oxygen to a user in a breathing system, said amount of oxygen
determined by comparing a desired blood-oxygen content level with a
measured blood-oxygen content level, said amount of oxygen
delivered to said user when a period of inhalation of said user is
detected, said amount of oxygen provided to said user continuously
automatically adjusted based upon said desired and measured
blood-oxygen content levels; and determining an average flow rate
of oxygen delivered to said user and triggering an alarm if said
overage flow rate of oxygen changes by an amount exceeding a
predetermined amount.
47. The method in accordance with claim 46 including the step of
opening a valve to provide said amount of oxygen.
48. The method in accordance with claim 46 including the step of
utilizing flow rate data received as an output of a flow sensor to
calculate said average flow rate.
49. The method in accordance with claim 46 including the step of
storing said flow rate data.
50. A method of controlling a flow of supplemental oxygen from an
oxygen supply to a user through a delivery apparatus in an
open-loop breathing system, the delivery apparatus including a
valve moveable between a first position to flow from said supply to
said user and a second position for preventing oxygen to flow from
said supply to said user, comprising the steps of: receiving a goal
blood-oxygen saturation level of a user; determining an actual
blood-oxygen saturation level of a user; determining a breath rate
of said user; sensing periods of inhalation by said user;
determining a length of time said valve should be moved to said
first position in order to deliver a desired quantity of oxygen,
said determining step comprising determining a first maximum time
if said actual level has not reached said goal level or said actual
level is below a minimum level, determining a second minimum time
if said actual level is above said goal level, and determining a
variable time if said actual level has at least once reached said
goal level but said actual level is between said minimum level and
said goal level, said step of determining a variable time including
determining a breath rate of said user from said sensed periods of
inhalation by said user, determining a delivery volume comprising a
desired quantity of oxygen divided by said breath rate, and
determining said variable time by dividing said delivery volume by
a flow rate of supplemental oxygen available; detecting the
initiation of inhalation by said user; and moving said valve from
said second position to said first position for said determined
length of time; and returning said valve to said first
position.
51. The method in accordance with claim 50 wherein said step of
determining a blood oxygen saturation level comprises measuring a
blood-oxygen saturation level of said user with a
pulse-oximeter.
52. The method in accordance with claim 50 wherein said step of
determining the initiation of inhalation by a user comprises
sensing a drop in pressure at said delivery apparatus.
53. The method in accordance with claim 50 wherein said desired
quantity of oxygen comprises a maximum quantity when said actual
level is below said minimum level.
54. The method in accordance with claim 50 wherein said desired
quantity of oxygen comprises a linearly changing quantity between a
minimum quantity corresponding to said minimum time and a maximum
quantity corresponding to said maximum time.
55. The method in accordance with claim 50 wherein said step of
moving said valve comprises applying a signal to said valve causing
said valve to be retained in its first position for said determined
length of time.
56. The method in accordance with claim 50 wherein said determined
length of time does not exceed one-half of an inhalation time of
said user.
57. A portable oxygen delivery control apparatus for controlling a
flow of oxygen to a user in an open-loop breathing system including
an oxygen supply and a delivery apparatus for delivering
supplemental oxygen to a user comprising: an oximeter arranged to
measure a blood-oxygen saturation level of a user and provide an
output signal indicative of said blood-oxygen saturation level; a
valve, a first port of said valve adapted to be connected to said
oxygen supply and a second port adapted to be connected to said
delivery apparatus, said valve having a first position permitting
oxygen to flow from said supply to said delivery apparatus, and a
second position preventing oxygen from flowing from said supply to
said delivery apparatus; a pressure sensor, said sensor associated
with a said valve, said sensor including a diaphragm exposed to the
atmosphere on opposing sides so as to be altitude correcting and
arranged to detect a period of inhalation by said user by detecting
a condition of reduced pressure associated with said delivery
apparatus for delivering supplemental oxygen to a user when said
valve is in said second position; a selector adapted to accept a
target blood-oxygen saturation level; a flow sensor, said flow
sensor positioned along a flow path between said oxygen supply and
said delivery apparatus, said flow sensor configured to generate
information regarding a flow rate of oxygen delivered from said
oxygen supply to said user; and a processor arranged to calculate a
time period which said valve should be maintained in its first
position to cause a desired amount of oxygen to be delivered to
said user when said oximeter indicates a blood-oxygen saturation
level which is below said goal blood-oxygen saturation level and
arranged to generate a signal for said time period, which signal
applied to said valve moves said valve to said first position and
causes oxygen to be delivered to said user when a condition of
inhalation is detected by said pressure sensor, and said signal
when removed from said valve causes said valve to be moved to said
second position, and said processor configured to utilize flow rate
information generated by said flow sensor and trigger an alarm in
the event said utilized flow rate information meets a predetermined
criteria.
58. The apparatus in accordance with claim 57 including a memory
associated with said processor, said memory configured to store
flow rate information.
59. The apparatus in accordance with claim 57 wherein said alarm
comprises an audible warning.
60. The apparatus in accordance with claim 57 wherein said alarm
comprises a visual warning.
61. The apparatus in accordance with claim 57 wherein said
processor, flow sensor, valve and pressure sensor are associated
with a printed circuit board located within a housing and said
selector comprises a user-actuatable input extending from said
housing.
62. A method of controlling a flow of supplemental oxygen from an
oxygen supply to a user through a delivery apparatus in an
open-loop breathing system, the delivery apparatus including a
valve moveable between a first position permitting oxygen to flow
from said supply to said user and a second position for preventing
oxygen to flow from said supply to said user comprising the steps
of: receiving a goal blood-oxygen saturation level of a user;
determining an actual blood-oxygen saturation level of a user;
determining a length of time said valve should be moved to said
first position in order to deliver a desired quantity of oxygen to
achieve said goal blood-oxygen saturation level based upon said
actual blood-oxygen saturation level; detecting the initiation of
inhalation by said user; moving said valve from said second
position to said first position for said determined length of time
when said inhalation is detected; returning said valve to said
second position; and generating at two or more times information
regarding an average flow rate of oxygen delivered from said supply
to said user; determining if a change in average flow rate exceeds
a predetermined amount and, if so, triggering an alarm.
63. The method in accordance with claim 62 wherein said step of
determining a blood-oxygen saturation level comprises measuring a
blood-oxygen saturation level of said user with a
pulse-oximeter.
64. The method in accordance with claim 62 wherein said step of
determining the initiation of inhalation by a user comprises
sensing a drop in pressure at said delivery apparatus.
65. The method in accordance with claim 62 wherein said
predetermined amount comprises a predetermined percentage change in
average flow rate.
66. The method in accordance with claim 62 wherein said step of
triggering an alarm comprises illuminating a light.
67. The method in accordance with claim 62 wherein said step of
triggering an alarm comprises emitting an audible noise.
68. The method in accordance with claim 62 including the step of
storing flow rate information received from said output of said
flow sensor and utilizing said stored information to generate said
average flow rate.
69. The method in accordance with claim 62 wherein said step of
generating information regarding an average flow rate comprises
generating flow rate information with a flow sensor and utilizing
said flow rate information to generate information regarding
average flow rate.
70. A method of controlling a flow of oxygen from an oxygen supply
to a user comprising the following steps: providing an amount of
oxygen to a user in a breathing system, said amount of oxygen
determined by comparing a desired blood-oxygen content level with a
measured blood-oxygen content level, said amount of oxygen
delivered to said user when a period of inhalation of said user is
detected, said amount of oxygen provided to said user continuously
automatically adjusted based upon said desired and measured
blood-oxygen content levels; and determining an average flow rate
of oxygen delivered to said user and triggering an alarm if said
average flow rate of oxygen changes by an amount exceeding a
predetermined amount.
71. The method in accordance with claim 70 including the step of
opening a valve to provide said amount of oxygen.
72. The method in accordance with claim 70 including the step of
utilizing flow rate data received as an output of a flow sensor to
calculate said average flow rate.
73. The method in accordance with claim 70 including the step of
storing said flow rate data.
74. A method of controlling a flow of supplemental oxygen from an
oxygen supply to a user through a delivery apparatus in an
open-loop breathing system, the delivery apparatus including a
valve moveable between a first position to flow from said supply to
said user and a second position for preventing oxygen to flow from
said supply to said user, comprising the steps of: receiving a goal
blood-oxygen saturation level of a user; determining an actual
blood-oxygen saturation level of a user; determining a breath rate
of said user; sensing periods of inhalation by said user;
determining a length of time said valve should be moved to said
first position in order to deliver a desired quantity of oxygen,
said determining step comprising determining a first maximum time
if said actual level has not reached said goal level or said actual
level is below a minimum level, determining a second minimum time
if said actual level is above said goal level, and determining a
variable time if said actual level has at least once reached said
goal level but said actual level is between said minimum level and
said goal level, said step of determining a variable time including
determining a breath rate of said user from said sensed periods of
inhalation by said user, determining a delivery volume comprising a
desired quantity of oxygen divided by said breath rate, and
determining said variable time by dividing said delivery volume by
a flow rate of supplemental oxygen available; detecting the
initiation of inhalation by said user; and moving said valve from
said second position to said first position for said determined
length of time; and returning said valve to said second
position.
75. The method in accordance with claim 74 wherein said step of
determining a blood oxygen saturation level comprises measuring a
blood-oxygen saturation level of said user with a
pulse-oximeter.
76. The method in accordance with claim 74 wherein said step of
determining the initiation of inhalation by a user comprises
sensing a drop in pressure at said delivery apparatus.
77. The method in accordance with claim 74 wherein said desired
quantity of oxygen comprises a maximum quantity when said actual
level is below said minimum level.
78. The method in accordance with claim 74 wherein said desired
quantity of oxygen comprises a linearly changing quantity between a
minimum quantity corresponding to said minimum time and a maximum
quantity corresponding to said maximum time.
79. The method in accordance with claim 74 wherein said step of
moving said valve comprises applying a signal to said valve causing
said valve to be retained in its first position for said determined
length of time.
80. The method in accordance with claim 74 wherein said determined
length of time does not exceed one-half of an inhalation time of
said user.
Description
RELATED APPLICATIONS
[0001] This is a continuation of U.S. patent application Ser. No.
10/370,799, filed 20 Feb. 2003, which is a continuation of U.S.
patent application Ser. No. 10/076,001, filed 14 Feb. 2002, (issued
as U.S. Pat. No. 6,561,187), which is a continuation of U.S. patent
application Ser. No. 09/463,614, filed 25 Jan. 2000 (with a 35
U.S.C. .sctn. 371 date of May 8, 2000, now issued as U.S. Pat. No.
6,371,114), which is a U.S. National Stage Application of
PCT/US98/15490, filed 24 Jul. 1998, which claims priority to U.S.
Provisional Patent Application Serial No. 60/064,578, filed 4 Nov.
1997 and which also claims priority to (and is a
continuation-in-part of) U.S. patent application Ser. No.
08/900,686 filed 25 Jul. 1997, (issued as U.S. Pat. No. 6,532,958).
All of the above-identified patent applications are incorporated
herein by reference in their respective entireties
FIELD OF THE INVENTION
[0002] The present invention relates to the field of respiratory
oxygen supply systems and methods. More particularly, the present
invention provides demand delivery methods and systems that supply
respiratory oxygen when the patient is inhaling.
BACKGROUND
[0003] Respiratory oxygen is delivered to patients in both
sub-critical care situations in which oxygen is provided as a
supplement to room air that may be inhaled by the patients (often
referred to as "supplemental" oxygen delivery) and in critical care
situations in which the gases (particularly oxygen) inspired by
patients are closely controlled, possibly in connection with blood
gas measurements.
[0004] Continuous oxygen delivery in sub-critical and critical care
is, however, wasteful because oxygen is only needed by patients
when they are inhaling and the oxygen delivered at other times is
wasted. In supplemental oxygen delivery, the most significant
financial cost associated with this waste is found in the increased
service visits required by the oxygen provider to replenish the
patient's oxygen supply, because the actual cost of the oxygen is
only a small fraction of the total cost of the therapy. In critical
care environments, the capacity of the oxygen delivery system must
be increased to account for the oxygen delivered when the patient
is exhaling.
[0005] One approach to conserving the oxygen delivered to patients
is typically referred to as "demand delivery." The demand delivery
systems respond to a patient's inspiratory effort by attempting to
deliver oxygen during the period of inhalation, rather than allow
the oxygen to flow to the patient continuously. There are many ways
in which this basic concept has been implemented.
[0006] A variety of respiration detection systems have been
developed in connection with demand delivery systems. Examples of
some respiration detectors include a chest belt worn by the patient
that generates an electrical signal to trigger the opening of the
oxygen supply valve; a hand-activated breathing device attached to
a portable gas bottle via a supply hose in which users dispense the
oxygen by pushing a button while holding the device next to their
mouth; a mechanical chest strap/valve that functions as both an
inhalation sensor and delivery device in an oxygen conserving
system; and an all-pneumatic, fluidically-controlled device.
[0007] Other demand delivery systems use pressure sensors in the
oxygen line to monitor line pressure at the nostrils. A small
negative pressure, indicative of the onset of inhalation, is often
relied on to trigger the release of oxygen. This type of detection
scheme has become a standard method of demand delivery and is
employed by most systems currently in use.
[0008] Yet another approach employs flow sensors to monitor patient
respiration. In many of these demand delivery systems, the flow
sensors are located in-line with the source of oxygen such that, in
addition to monitoring patient respiration, the flow sensors also
monitor the amount of oxygen passing through them during the oxygen
delivery portion of the cycle. It is, however, difficult (if not
impossible) to accomplish both of those functions with a single
flow sensor because the flow rates that need to be sensed differ by
orders of magnitude. For example, when measured using a nasal
cannula, patient respiration may result in flow rates at the flow
sensor of about 1 cubic centimeters per minute (cc/min) or less,
while the flow rate of oxygen delivered to the patient can be up to
about 15 liters per minute (l/min) or more. One significant problem
is in sensing inhalation or exhalation simultaneously with the
delivery of oxygen in these situations. Examples of this approach
are found in U.S. Pat. No. 4,823,788 (Smith et al.) and U.S. Pat.
No. 5,558,086 (Smith et al.).
[0009] In addition to the above-listed problems, even if the flow
sensor has a dynamic range capable of sensing respiration and
delivery oxygen, the systems do not allow for correction in the
"drift" often associated with such sensors. In other words, over
time the accuracy of the sensor may be impaired because of dynamic
changes in the flow sensor during use. Because the flow sensors are
always in use, monitoring either oxygen flow or respiration,
adjustments are difficult if not impossible to make to correct for
voltage drift.
[0010] Another flow sensor-based demand delivery system is
described in U.S. Pat. No. 5,074,299 (Dietz) in which a flow sensor
is connected to one port of a nasal cannula while oxygen is
delivered through the other port of the cannula. One disadvantage
to this approach is that if one side of the patient's nasal cavity
is blocked due to an upper respiratory infection or cold, the
system will either be unable to effectively deliver oxygen or sense
respiration (depending on which port of the cannula is located on
the blocked side).
[0011] Even if the patient is not experiencing blockage, it may be
difficult for the sensor to detect exhalation if the patient is
breathing through his or her mouth. The nasal respiratory flow rate
is significantly reduced in such patients, and if flow sensing is
occurring only through one port in the cannula, it may be too low
to be accurately detected. Another disadvantage is that the system
requires a more expensive and obscure dual-line cannula.
[0012] Regardless of whether pressure or flow sensors are used to
detect respiration, shallow respiration can make respiration
sensing in systems relying on pressure/flow sensors difficult or
impossible because the flow volume and/or flow rate of gases
associated with respiration deteriorate as the gases from
inhalation or exhalation travel through the lines connecting the
patient's respiratory system to the sensor. The flow volume/rate
deterioration caused by the lines further reduces the flow
volume/rate produced by a patient engaging in shallow respiration.
As a result, the respiration sensor may be unable to detect
respiration or may detect only a portion of the actual
inhalation/exhalation events.
[0013] Another problem associated with patients experiencing rapid
respiration rates is that some demand delivery systems include a
time delay period to prevent sensing of the same inhalation period
more than once. These systems operate on the assumption that each
inhalation lasts for a predetermined minimum amount of time and the
system is prevented from sensing inhalation within the delay
period. Because the patient is, however, experiencing rapid
respiration, the patient may actually inhale two or more times
during the delay period. The effect of such a "lockout" feature is
that the patient will receive oxygen during only a fraction of
their inhalation events. In addition, if the respirations are rapid
and the system delivers oxygen too slowly, the patient may already
be exhaling by the time the system begins to deliver oxygen.
SUMMARY OF THE INVENTION
[0014] The present invention provides respiratory oxygen supply
methods and systems. In some aspects, the systems/methods rely on
respiration sensors sensing variations in patient respiration to
determine when a patient is inhaling and allow for the
determination of an inhalation event after exhalation has been
determined. In other aspects, the respiration sensors may be
advantageously used to detect the presence of oxygen from the
oxygen supply. In still other aspects, when the present invention
uses a flow sensor as a respiration sensor, the system may
automatically correct for variations in the signals provided by the
flow sensor using a zero-flow offset signal, thereby improving the
accuracy of the system.
[0015] In one aspect, the present invention provides a method of
delivering respiratory oxygen to a patient by providing an oxygen
delivery system including an oxygen delivery device, a respiration
sensor, and an oxygen source; placing the delivery device in fluid
communication with the respiration sensor and monitoring variations
in respiration with the respiration sensor to determine when the
patient is inhaling; placing the oxygen source in fluid
communication with the delivery device; delivering oxygen to the
delivery device from the oxygen source when the patient is
inhaling; removing the respiration sensor from fluid communication
with the delivery device when delivering oxygen to the delivery
device from the oxygen source; placing the respiration sensor in
fluid communication with the delivery device after delivering
oxygen to the delivery device from the oxygen source; monitoring
variations in respiration with the respiration sensor after
delivering oxygen to the delivery device from the oxygen source to
determine when the patient is exhaling; and resuming the monitoring
of variations in respiration with the respiration sensor to
determine that the patient is inhaling after determining that the
patient has exhaled.
[0016] In another aspect, the present invention provides a method
of delivering respiratory oxygen to a patient by providing an
oxygen delivery system including an oxygen delivery device, a
respiration sensor, and an oxygen source; placing the delivery
device in fluid communication with the respiration sensor and
monitoring variations in respiration with the respiration sensor to
determine when the patient is inhaling; placing the oxygen source
in fluid communication with the delivery device; delivering oxygen
to the delivery device from the oxygen source when the patient is
inhaling; removing the respiration sensor from fluid communication
with the delivery device when delivering oxygen to the delivery
device from the oxygen source; placing the respiration sensor in
fluid communication with the delivery device after delivering
oxygen to the delivery device from the oxygen source; and
monitoring the respiration sensor to detect oxygen in the oxygen
source.
[0017] In another aspect, the present invention provides a method
of delivering respiratory oxygen to a patient by providing an
oxygen delivery system including an oxygen delivery device, a flow
sensor, and an oxygen source; placing the delivery device in fluid
communication with the flow sensor and monitoring variations in
respiration with the flow sensor to determine when the patient is
inhaling; placing the oxygen source in fluid communication with the
delivery device; delivering oxygen to the delivery device from the
oxygen source when the patient is inhaling; removing the
respiration sensor from fluid communication with the delivery
device when delivering oxygen to the delivery device from the
oxygen source; placing the flow sensor in fluid communication with
the delivery device after delivering oxygen to the delivery device
from the oxygen source; monitoring a zero-flow offset signal
produced by the flow sensor when it is not in fluid communication
with the delivery device; and compensating for drift in the
zero-flow offset signal generated by the flow sensor based on the
monitoring when the flow sensor is not in fluid communication with
the delivery device.
[0018] In another aspect, the present invention provides a method
of delivering respiratory oxygen to a patient by providing an
oxygen delivery system including an oxygen delivery device, a
bidirectional flow sensor vented to atmosphere, and an oxygen
source; placing the delivery device in fluid communication with the
flow sensor and monitoring variations in respiration with the flow
sensor to determine when the patient is inhaling; placing the
oxygen source in fluid communication with the delivery device;
delivering oxygen to the delivery device from the oxygen source
when the patient is inhaling; removing the flow sensor from fluid
communication with the delivery device when delivering oxygen to
the delivery device from the oxygen source; placing the flow sensor
in fluid communication with the delivery device after delivering
oxygen to the delivery device from the oxygen source; monitoring
variations in respiration with the flow sensor when it is in fluid
communication with the delivery device to determine when the
patient is exhaling before resuming the monitoring of variations in
respiration with the flow sensor to determine that the patient is
inhaling; monitoring a zero-flow offset signal produced by the flow
sensor when it is not in fluid communication with the delivery
device; compensating for drift in the zero-flow offset signal
generated by the flow sensor based on the monitoring when the flow
sensor is not in fluid communication with the delivery device; and
monitoring the flow sensor to detect oxygen in the oxygen source
when switching the delivery device from fluid communication with
either of the oxygen source and the flow sensor.
[0019] In another aspect, the present invention provides a system
for delivering respiratory oxygen to a patient including a delivery
line adapted for connection to an oxygen delivery device located on
a patient; a source line adapted for connection to an oxygen
source; a respiration sensor; at least one valve in fluid
communication with the delivery line, the source line and the
respiration sensor; wherein the at least one valve places the
delivery line in fluid communication with only one of the source
line and the respiration sensor at any given time; means for
monitoring the respiration sensor for variations in respiration of
a patient; means for determining when the patient is inhaling and
exhaling based on the monitoring of the respiration sensor; and
means for preventing a determination that the patient is inhaling
until after a determination that the patient has exhaled has been
made.
[0020] In another aspect, the present invention provides a system
for delivering respiratory oxygen to a patient including a delivery
line adapted for connection to an oxygen delivery device located on
a patient; a source line adapted for connection to an oxygen
source; a respiration sensor; at least one valve in fluid
communication with the delivery line, the source line and the
respiration sensor; wherein the at least one valve places the
delivery line in fluid communication with only one of the source
line and the respiration sensor at any given time; means for
monitoring the respiration sensor to detect oxygen in the source
line.
[0021] As used in connection with the present invention, the terms
"supplemental oxygen" and "supplemental respiratory oxygen" refer
to oxygen delivered to patients in addition to the oxygen received
by the patient through the inspiration of room or ambient air.
Because room air contains some oxygen, the supplemental oxygen is
provided in addition to the oxygen that would normally be inspired
by the patient.
[0022] As used in connection with the present invention, the term
"blood oxygen content" and "blood oxygen content level" will
typically be used to refer to blood oxygen saturation as commonly
measured by the percentage of oxygen-saturated hemoglobin
(SpO.sub.2) although it can also refer to any suitable measurement
for determining the level of oxygenation in a patient's blood. For
example, it will be understood that blood oxygen content can also
be obtained based on data from a CO-oximeter. Furthermore, blood
oxygen content, can also be obtained based on partial pressures of
oxygen (PaO.sub.2).
[0023] As used in connection with the present invention, the term
"sub-acute care" refers to care provided to patients that is not
intended to treat critical conditions. Typically, sub-acute care is
provided to patients in residential settings. "Residential"
preferably includes, e.g., homes and long-term care facilities
(such as nursing homes). Sub-acute care also includes care
delivered in ambulatory situations, i.e., when the patient is
engaged in normal activities outside of his or her residence, such
as shopping, attending concerts or other events, traveling to
appointments with health care professionals, etc.
[0024] As used in connection with the present invention, the terms
"continuous" and "continuously" (when referring to the measuring of
blood oxygen content levels) mean that the blood oxygen content
level of the patient will be measured without cessation or at
intervals (fixed or variable) that are sufficiently small to
provide the advantages of the invention.
[0025] These and other features and advantages of the present
invention will be apparent upon review of the detailed description
of the invention and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 is a block diagram of one system according to the
present invention.
[0027] FIG. 2 is a block diagram of one demand delivery module for
use in a system such as that depicted in FIG. 1.
[0028] FIG. 3a is a flow diagram of one method according to the
present invention.
[0029] FIG. 3b is a flow diagram of another method according to the
present invention.
[0030] FIG. 4 is a flow diagram of one method of delivering
supplemental oxygen based on whether the measured blood oxygen
content data is valid or invalid.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS OF THE
INVENTION
[0031] As described above, the present invention provides demand
respirating oxygen supply methods and apparatus for use in
sub-acute care which maintain healthy blood oxygen saturation in
patients by controlled dosing of oxygen with a measured response to
the patient's actual blood oxygen content. The dosing can be
provided by simple on/off control over the delivery of oxygen or
the amount of oxygen delivered to the patient with each inhalation
can be varied in response to the patient's need as determined by a
more sophisticated control scheme, such as a
proportional-integral-derivative (PID) loop control algorithm, that
utilizes the difference between the patient's measured blood oxygen
content level and a desired or target blood oxygen content
level.
[0032] The systems and methods of the present invention are
particularly directed at patients receiving supplemental oxygen in
a sub-acute care environment, more preferably in a residential
setting. The needs and considerations of patients receiving
supplemental oxygen in sub-acute care differ from those present
when providing oxygen to patients in critical care environments, in
which the amounts of oxygen delivered to patients are carefully
controlled in connection with masks or other enclosures that do not
typically allow the patents to inspire room air in uncontrolled
manners. In those situations, the fractional amount of inspired
oxygen (FIO.sub.2) is typically controlled by mixing oxygen and air
in a blender or other device before delivering the gas to the
patient.
[0033] Among the advantages of the present invention are the
significant conservation of oxygen provided by delivering only the
amount of oxygen needed to maintain a healthy blood oxygen content
and the ability to address therapeutic problems associated with
demand delivery systems by providing the correct amount of oxygen
to the patient to reduce uncontrolled hypoxic events.
[0034] The amounts of oxygen that can be conserved by implementing
the methods according to the present invention can be significant,
even compared to known demand delivery systems that conserve oxygen
by simply turning the supply on or off during a patient's
respiration. Studies have reported oxygen savings ratios of from
3:1 to 7:1 for known simple demand delivery systems. In other
words, a fixed amount of oxygen can last three to seven times as
long as the same amount of oxygen would last in a supplemental
oxygen delivery system that does not include a simple demand
delivery system. Implementation of the methods according to the
present invention by using a demand delivery approach with a
feedback control mechanism that responds to a continuous blood
oxygenation measurement could provide an oxygen savings ratio of
greater than 13:1 while maintaining the patient's SaO.sub.2 at the
90% level.
[0035] Other advantages of the methods and apparatus according to
the present invention are the ability to integrate the invention
with any sub-acute care supplemental oxygen supply system,
including both ambulatory and stationary sources. For unlimited
volume sources, such as oxygen concentrators and membrane
separators, the invention will reduce their size and energy
consumption for a given level of therapy. For fixed volume gas
sources, such as liquid and high pressure gas, the invention will
extend the lifetime of the oxygen supply, thereby significantly
decreasing the cost of providing that treatment.
[0036] If the system is ambulatory, the present invention can allow
for reductions in the size and weight of the oxygen source, thereby
increasing the patient's mobility. An added benefit of reducing the
size and/or weight of the ambulatory systems is the potential for a
better therapeutic outcome. If patients find the smaller, lighter
weight systems less cosmetically unattractive they will be more
likely to carry and use the systems during ambulatory activities as
opposed to not using the systems. Studies have shown that the
benefit of supplemental oxygen systems is significantly reduced if
the systems are not used on a regular basis.
[0037] Another advantage of the invention, method and apparatus, is
a reduction in the risk of hypercapnia (carbon dioxide retention)
by only providing enough oxygen to reach a predetermined blood
oxygen saturation, typically about 90% as measured by a
conventional two-color pulse oximeter.
[0038] One embodiment of an automated respiratory oxygen supply
system is depicted in FIG. 1 and includes a controller 10, a demand
delivery module 12, and a blood oxygen content sensor 14 connected
to the patient 16. Oxygen is supplied from an oxygen source 20 to
the patient 16 by the demand delivery module 12 through, in the
preferred embodiments, a supplemental oxygen delivery device 18.
The preferred system may also include a user interface 32 and an
alarm 38.
[0039] The supplemental oxygen delivery device 18 is preferably a
nasal cannula as depicted in FIG. 1, although it will be understood
that the supplemental oxygen delivery device can take the form of
any device designed to provide supplemental respiratory oxygen to a
patient while not preventing the patient from also inspiring room
or ambient air in addition to the supplemental respiratory oxygen
from an oxygen source. Examples of other supplemental oxygen
delivery devices include, but are not limited to: tracheal
catheters, nasal masks designed for use with Continuous Positive
Airway Pressure (CPAP) systems, vented masks that cover both the
nose and the mouth but that allow inspiration of room air in
uncontrolled amounts in addition to the supplemental oxygen
delivered to the mask, etc.
[0040] Oxygen source 20 could be an oxygen concentrator, membrane
separator, high pressure cylinder or liquid oxygen dewar. This
could also include any portable versions of oxygen sources 20.
Other potential sources of oxygen gas suitable for providing
supplemental oxygen in sub-acute care in a residential setting
and/ambulatory situations may be created in the future and should
be considered as being functional with the described invention. As
used below, "line" will refer to any connection made between the
oxygen source, the described invention and the patient.
[0041] If the oxygen source 20 is an oxygen concentrator, typically
a continuous low-flow device, usually delivering at most 6
liters/min of 96% oxygen, the system may also include an oxygen
storage device to accommodate the periodic higher flows that are
necessary to practice the methods described below. If high flow
concentrators become available, such a storage device would not be
needed.
[0042] One controller 10 is an electronic circuit including a
software programmable microcontroller as its main component.
Depending on the allocation of tasks within the device a number of
microcontrollers could be used as a controller 10. In one
embodiment, the controller 10 includes a serial data input port,
A/D converter, LED driver capabilities and digital I/O pins. One
example of a suitable controller is the PIC 16C74A microcontroller
from Microchip Technology Inc. of Chandler, Ariz.
[0043] Those skilled in the art will realize that a great deal of
optimization may be done relative to the choice of a
microcontroller(s). Specifications, such as power consumption,
cost, memory size, clock speed and part availability may alter the
choice for a preferred microcontroller. Furthermore, many of the
functions described for the microcontroller in the preferred
embodiment could be accomplished by using discrete circuits of many
types. Additionally, the microcontroller and its peripheral
circuitry may be replaced entirely by discrete circuitry, such as
programmable logic arrays, A/D converter chips, analog comparators,
etc.
[0044] The system also includes an oxygen content sensor 14 for
monitoring the blood oxygen content of the patient 16. One suitable
sensor 14 includes a sensor control module 14a and a sensor 14b
typically mounted or attached to the patient 16 by some suitable
technique. The information from the oxygen content sensor 14 is fed
back to the controller 10 for use in executing the methods
according to the present invention. It is preferred, but not
required, that the oxygen sensor 14 provide a signal to the system
controller 10 in the form of a blood oxygen saturation in percent.
The sensor 14 preferably, but not necessarily, processes all of its
data internally and the controller 10 preferably processes only
error flags and numerical information as described shortly.
[0045] One preferred oxygen sensor 14 is a non-invasive sensor such
as a two-color pulse oximeter. As used herein, the terms "pulse
oximeter" or "oxygen sensor" will include both the optical sensor
and the circuitry used to determine blood oxygen saturation levels
using the optical sensor. One example of a suitable pulse oximeter
is a conventional two-color, OEM-II oximeter module, from Nonin
Medical Inc. of Plymouth, Minn., that can measure the percentage of
oxygen-saturated hemoglobin, SpO.sub.2, in the blood stream of an
in vivo respiratory system. The preferred embodiment of the pulse
oximeter 14 uses a transmitting sensor that attaches to the user's
finger. Alternative embodiments may employ sensors that attach
elsewhere on the body.
[0046] While the pulse oximeter is one preferred non-invasive
oxygen sensor, it should be understood that any blood oxygen
sensor, invasive or non-invasive, useful for determining blood
oxygen content levels (preferably continuously) could be used in
connection with the present invention. It should also be apparent
to those skilled in the art that technologies on the horizon, such
as an implantable, micro-electromechanical (MEMS) blood gas
analyzer, may provide the blood oxygen content information needed
by the system controller 10. Furthermore, there may be improvements
in pulse oximetry technology, such as the ability to determine the
level of carboxyhemoglobin in the blood, that may be useful for the
described invention. Use of these new blood oxygen content
technologies in oxygen conservers for long-term oxygen therapy
should be considered to lie within the scope of the systems and
methods of the present invention provided they have the ability to
provide suitable blood oxygen content measurements.
[0047] In one embodiment, the pulse oximeter 14 deconvolves the
optical information into a blood oxygen saturation value,
SpO.sub.2, in percent. The oximeter 14 outputs a serial data stream
with this information to the controller 10 for evaluation. Other
important information may also be included in the oximeter data
stream, such as the user's pulse rate and error flags that detail
the reliability of the SPO.sub.2 and pulse rate values.
[0048] It will be recognized by those skilled in the art that an
alternative embodiment may be provided in which the system
controller 10 functions as the sensor control module 14a. As a
result, data evaluation and error handling would be accomplished
within the system controller 10 with an appropriate oxygen sensor
14b being attached to the patient 16.
[0049] Blood oxygen content measuring in connection with the
present invention is described as "continuous" although it will be
understood that the measurements made using, e.g., pulse oximeters
and other devices, may actually be taken at discrete intervals. As
discussed above, "continuous" as used in connection with the
measuring of blood oxygen content in the present invention includes
measurement of the blood oxygen content levels of the patient at
intervals (fixed or variable) that are sufficiently small to
provide the advantages of the invention. Preferably the sampling
intervals will be less than about five minutes, more preferably
less than about one minute, and even more preferably less than
about one respiration interval (i.e., the time between the onset of
two inhalations by the patient).
[0050] The information relating to blood oxygen content provided by
the oxygen sensor 16 is then used by the system controller 10 in
combination with the demand delivery module 12 to provide control
over the oxygen supplied to the patient 16 from the oxygen source
20 as described in connection with the methods according to the
present invention below.
[0051] A block diagram illustrating the components of one
embodiment of a demand delivery module 12 according to the present
invention is depicted in FIG. 2. One component in the demand
delivery module 12 is an inhalation or respiration sensor 40 that
monitors the respiratory activity of the patient 16 to determine
variations in respiration of the patient. It is preferred that the
variations in respiration allow the determination of when the
patient is inhaling, although other portions of the respiratory
cycle may actually be sensed. In other words, inhalation is
preferably sensed, but in some cases it may be desirable to
determine when inhalation is occurring based on the sensing of some
other condition, activity, etc. such as chest movement, exhalation,
etc.
[0052] In one embodiment, the respiration sensor 40 provides a
signal to a respiration sensor/valve controller 42 that, in turn,
controls the valve 26 based on additional input from system
controller 10 (as will be described in more detail below).
[0053] The respiration sensor 40 can take a variety of forms that
will be known to those skilled in the art. One type of suitable
respiration sensor 40 monitors flow in the line used to supply
oxygen to the supplemental oxygen delivery device 18. The sensor 40
in FIG. 2 monitors flow through the valve 26 interposed in the line
between the supplemental oxygen delivery device 18 and the oxygen
source 20. One suitable flow sensor is a Honeywell AWM2150
Microbridge Mass Airflow Sensor (available from Honeywell Corp.,
Minneapolis, Minn.).
[0054] Another feature of the preferred respiration sensor 40 is
the ability to sense bidirectional flow, i.e., flow in each
direction through the sensor 40. It is preferred that the flow
generated by inhaling causes a voltage output of one polarity from
the sensor 40, while flow generated by exhaling causes an output
voltage of the opposite polarity. In any event, it is preferred
that the sensor 40 be capable of detecting both inspiration and
expiration.
[0055] In addition to the preferred flow sensor, it should be
understood that other types of sensors may be utilized to detect
variations in respiration, preferably inhalation and exhalation.
Those skilled in the art will recognize that pressure transducers,
thermistors or infrared detectors may all be used to sense
inhalation. In one example, a pressure transducer with the
appropriate sensitivity, such as a solid-state piezoresistive,
capacitive or electromechanical device, could be used to generate
an electrical signal in response to the breathing cycle. In another
example, thermistors could be used to detect changes in airflow due
to respiration. If the thermistor was sufficiently sensitive, one
may be able to ascertain the onset of inhalation by monitoring the
temperature of a thermistor (or thermocouple) placed near the
nostril. A flow measurement may also be possible with the use of
two thermistors in an anemometer configuration. Infrared detectors,
such as single element bolometers, could be used as well if they
possess the speed and accuracy to distinguish variations in
respiration.
[0056] The respiration sensor 40 provides a signal to the
respiration sensor/valve controller 42 which compares the signal to
a predetermined reference level. The respiration sensor/valve
controller 42 identifies the onset of inhalation by triggering when
the sensor signal reaches the predetermined reference level. The
respiration sensor/valve controller 42 then provides a signal to
position the spool of valve 26 so oxygen flows from supply 20 to
patient 16 via supplemental oxygen delivery device 18. The spool of
the valve 26 remains in this position for a period of time, the
"dose time" (D), as specified by the system controller 10. In this
manner, a dose of oxygen of duration D can be provided when the
patient is inhaling.
[0057] One preferred valve 26 of the embodiment of FIG. 2 is a
three-way, two-position, solenoid-actuated spool valve having three
ports 26a, 26b, 26c. Common port 26a is connected to the in vivo
respiratory system of the patient 16 by the supplemental oxygen
delivery device 18. Normally closed port 26b is connected to the
oxygen source 20 and normally open port 26c is connected to
respiration sensor 40 (with the other end of the preferred
respiration sensor left open to atmosphere). One preferred valve 26
is manufactured by The Lee Company, of Westbrook, Conn., Model HDI
LHDA0523111H.
[0058] When oxygen is not being supplied to the patient 16, the
spool of the valve 26 is positioned such that common port 26a and
normally open port 26c are connected so that the respiration sensor
40, supplemental oxygen delivery device 18, and patient 16 are in
fluid communication, corresponding to the OFF position of the valve
26. This allows the respiratory effort of the patient 16 to be
detected by the respiration sensor 40, through the monitoring of
the flow generated in the supplemental oxygen delivery device 18 by
inspiratory and expiratory efforts.
[0059] To supply oxygen to the patient 16, the spool of the valve
26 is moved so as to connect common port 26a and normally closed
port 26b, corresponding to the ON position of the valve 26. This,
in turn, allows for flow of respiratory oxygen to the patient 16
from supply 20 through the valve 26 and the supplemental oxygen
delivery device 18.
[0060] The ON period for the valve 26, corresponding to the dosage
period as discussed below, is preferably shorter than the
inhalation period for the patient. As a result, the patient may
often be inhaling after the valve 26 is OFF (i.e., closed). To
reduce or prevent multiple openings of the valve 26 during a single
inhalation, it is preferred that the valve 26 remain closed until
the sensor 40 detects the onset of exhalation. Once exhalation is
detected based on the sensor 40, the system can then resume
monitoring for the onset of inhalation, whereupon the cycle is
repeated.
[0061] Because the preferred valve 26 is a 3-port valve, there is a
short period after opening or closing the valve 26, (the "bounce
period") where the sensor output voltage spikes or bounces due to
oxygen leaking from the normally closed port 26b to the normally
open port 26c while the valve spool is still moving. Once the valve
26 is fully ON or OFF and the valve spool has stopped moving, the
bounce signal disappears. It is preferred that monitoring of the
respiration sensor 40 be adjusted to avoid false readings due to
the bounce signal after turning the valve 260N or OFF. This
adjustment can take the form of a delay in monitoring the signal
provided by the sensor 40 after moving the valve 26 between the ON
and OFF positions until the bounce signal has passed.
[0062] In some systems, the bounce signal may be monitored and used
advantageously. The bounce signal (whether generated during ON or
OFF movement of the valve spool) may be used to detect the presence
of oxygen at the supply 20. No bounce signal may indicate that no
oxygen is present because of the lack of pressurized oxygen at
normally closed port 26b. In the preferred embodiment, the bounce
signal generated by turning the valve 26 to the OFF position (i.e.,
closing port 26b) is used for this check because that bounce signal
is typically larger and longer in duration than the bounce signal
generated by turning the valve 26 to the ON position (i.e., opening
port 26b).
[0063] Another advantage of the 3-port valve 26 is that sensor's
zero-flow offset voltage can be checked while the valve 26 is in
the ON position. The measured sensor offset voltage signal (Vo) can
be used to generate a correction for drift in the sensor offset
voltage. After the valve 26 has been ON longer than the valve-ON
bounce period, the signal from the respiration sensor 40 can be
read and recorded for use in, e.g., a software-generated correction
for zero-flow sensor offset voltage. This sensor offset voltage
signal is obtained from the respiration sensor 40 when the valve 26
is ON because no flow is to be expected through the respiration
sensor 40 under those conditions (port 26c is closed). In addition,
if this offset reading is greater (in absolute value) than a
predefined upper limit (VoMAX), this can be used to indicate either
sensor 40 or valve 26 failure; e.g., the sensor 40 has drifted too
far out of specification, the valve 26 is leaking, the valve 26 is
stuck in the OFF position, etc.
[0064] The demand delivery module 12 described above is a subsystem
that communicates to and receives communication from system
controller 10. In the described methods, it receives continually
updated values of the dose time D. It will be understood, however,
that those skilled in the art could design a demand delivery module
12 which is more or less dependent on the system controller 10 than
is described in this embodiment. For example, it may be desirable
to construct a system where respiration sensor 40 provides a signal
directly to the system controller 10 with no separate respiration
sensor/valve controller 42 being provided. The controller 10 would
then provide a control signal to valve 26 directly as well as
perform the other operations that are described as being performed
by the respiration sensor/valve controller 42.
[0065] Moreover, it should be understood that alternative designs
for the connections of the valve 26, respiration sensor 40, oxygen
source 20, and patient 16 may be envisioned by the those skilled in
the art. It would be possible to design a system in which an
in-line flow sensor and/or three-port, two-way valve are not
required. For example, the designs may involve a plurality of
valves and sensors. It should be understood that the methods and
systems of the described device operate independently from the
specific configuration of hardware used for sensing variations in
respiration and the specific valve configuration used to control
the flow of oxygen.
[0066] Although the demand delivery module 12 described above is
used to control delivery of supplemental oxygen to a patient from
the source 20, the demand delivery module 12 and the methods of
operating it as described above could find wider application. For
example, they could be used in connection with critical care
systems in which FiO.sub.2 is to be controlled via the use of masks
or other delivery devices used in connection with, e.g.,
respirators, ventilators, BIPAP (Bilevel Positive Airway Pressure)
systems, etc. As a result, the demand delivery module and methods
of operating it are not to be limited to use in connection with
systems and methods of delivering supplemental oxygen as part of a
sub-acute care regime.
[0067] As long as the data stream from the blood oxygen content
sensor 14 is valid (as described in detail below), the controller
10 can use the data to control delivery of oxygen to the patient.
The feedback control can be implemented as a portion of software
code contained in the controller 10; however, it could
alternatively be a hard-wired controller or combination of hardware
and software in other embodiments.
[0068] There exist a variety of control methods that are of utility
in the present method and invention. The goal of any control method
is stable operation of the controlled system about a setpoint or
desired value. In the preferred embodiment, the desired value is a
blood oxygen saturation (SpO.sub.2) of 90%. One control algorithm,
the ON/OFF method, is diagrammed in FIG. 3a. This diagram assumes
that the data generated by the blood oxygen content sensor is valid
(validity and invalidity of that data is discussed in more detail
below).
[0069] The system measures the patient's blood oxygen content level
100. With that information, a decision 102 is made. When the
measured blood oxygen content level is not below the desired value
no oxygen is delivered 104. When the measured blood oxygen content
level is below the desired value, oxygen is delivered 106. For
example, when the measured blood oxygen content level is not below
the desired value, controller 10 sets a dose time of zero (D=0),
thereby preventing the delivery of supplemental oxygen.
Alternatively, the system may otherwise restrict the flow of oxygen
by, e.g., reducing its flow to a very low value in an attempt to
conserve the supplemental oxygen source. The reduction in flow can
be accomplished using a variable flow valve or by introducing a
flow restrictor into the system between the source 20 and the
patient 16. When the measured blood oxygen content falls below the
desired value, controller 10 delivers supplemental oxygen to the
patient 16 by, e.g., setting a non-zero value (D>0) for the dose
time or otherwise increasing the flow of oxygen to the patient.
[0070] As long as the measured blood oxygen content level remains
below the desired value, the system provides oxygen when the
patient is inhaling. In one relatively simple implementation, the
"ON" dose time D could be very long. Preferably, however, the dose
time is equal to or shorter than a typical inhalation period, in
which case one or more pulses of duration D of oxygen are delivered
during inhalation. This ON/OFF control approach is analogous to the
operation of a furnace using a mercury switch thermostat, i.e.,
oxygen delivery is either ON or OFF.
[0071] The feedback control algorithm may alternatively use a
Proportional-Integral-Derivative (PID) loop as illustrated in FIG.
3b. Other embodiments could use algorithms based on fuzzy logic,
look-up tables, P or PI loops or increment/decrement methods
(oxygen delivery that increases or decreases in a preprogrammed
fashion relative to setpoint and/or trend). The PID algorithm is
fundamentally different from the simple ON/OFF control algorithm in
that it uses both the current value of the blood oxygen content and
also trend information to determine whether the patient needs
supplemental oxygen and, if so, how much oxygen should be delivered
when the patient is inhaling. Because of the use of trend
information, a system controlled with a PID loop will, at times,
deliver oxygen to the patient even if their blood oxygen content is
above the desired value; or, at other times, it may not deliver
oxygen even if they are below the desired value. An example of when
this might occur is when the patient's blood oxygen content was
above the desired value, but was also dropping very quickly. In
this case, the PID loop would start oxygen delivery before the
blood oxygen content actually fell below the desired value. (The
ON/OFF method would not start oxygen delivery until after the blood
oxygen content was below the desired value). This may allow a PID
control method to more effectively reduce the fluctuations of the
blood oxygen content about the desired value.
[0072] A simplified flow diagram of one such PID control system is
illustrated in FIG. 3b where the data stream of the measured blood
oxygen content level sensor is assumed to be valid
(validity/invalidity of that data is discussed in more detail
below). The system measures the patient's blood oxygen content
level 110. The current information is compared with earlier data
112 to determine how much oxygen (i.e., a variable dose), based on
the parameters of the PID loop 114, should be delivered to the
patient 116. In some instances, the parameters of the PID loop
indicate that no oxygen is to be delivered 118, and in other
instances some variable dose of oxygen will be delivered based on
the parameters of the PID loop.
[0073] The preferred systems for implementing the methods of the
present invention use a digital controller. As a result,
discretization of the following continuous-time PID control
equation must be performed:
D(t)=K.sub.p*[e(t)+(1/T.sub.i)*.intg.e(t')dt'+(T.sub.d)*de/dt]
(1)
[0074] where D(t) is the oxygen dose time at time t, K.sub.p is the
loop proportional gain, T.sub.i is the integral time, T.sub.d is
the derivative time, and where the integral is integrated over the
range of from zero to t. The preferred embodiment utilizes a first
order discretization of the continuous time PID equation. This can
be seen in Equation 2,
D(t.sub.n)=D(t.sub.n-1)+A.sub.0e(t.sub.n)+A.sub.1e(t.sub.n-1)+A.sub.2e(t.s-
ub.n-2) (2)
[0075] where D(t.sub.n) is the control signal (oxygen dose time)
generated for time period t.sub.n, e(t.sub.n) is the difference
between the desired level of blood oxygen saturation (the setpoint)
and the measured level at time t.sub.n. The coefficients, A.sub.0,
A.sub.1, and A.sub.2 are given by Equations 3-5 below:
A.sub.0=K.sub.p*(1+t.sub.n/t.sub.i+t.sub.d/t.sub.n) (3)
A.sub.1=-K.sub.p*(1+2*t.sub.d/t.sub.n) (4)
A.sub.2=K.sub.p*(t.sub.d/t.sub.n) (5)
[0076] where K.sub.p is the loop proportional gain, t.sub.i is the
integral time, t.sub.d is the derivative time and t.sub.n is the
period of the measurement (one second if using the preferred
oximeter).
[0077] As mentioned, the quantity e(t.sub.n) is the difference
between the SpO.sub.2 value at time t.sub.n and the desired value.
In one embodiment, a fixed setpoint of SpO.sub.2=90% is used for
the desired value. The control algorithm will specify doses of
oxygen in order to maintain the blood oxygen saturation at this
level. It is thought that this saturation level may provide the
necessary correction to the patient's hypoxemia, while at the same
time conserving the greatest amount of oxygen. It should be
apparent to those skilled in the art that the desired value
(setpoint) can be changed to achieve different therapeutic and
economic goals.
[0078] Moreover, a system that uses additional physiological
parameters, such as pulse rate or respiratory rate, in addition to
blood oxygen content as determined by the oxygen sensor to
determine a target blood oxygen level (setpoint) that changes on a
rolling basis could also be implemented. For example, one may use
the heart rate to monitor the patient's activity level and
therefore anticipate increased or decreased need of oxygen and
adjust the setpoint accordingly. Such schemes would be seeking to
ameliorate the possible increased/decreased hypoxemia caused by a
change in physical activity level. Such changes to the setpoint
should be considered to be within the spirit and scope of the
present invention.
[0079] Referring now to Equations 3-5 above, the transfer function
coefficients A.sub.0, A.sub.1 and A.sub.2 are determined by the
settings of loop proportional gain K.sub.p, the integral time
t.sub.i, the derivative time t.sub.d and the time between data
points t.sub.n. The determination of these values will typically be
accomplished through clinical monitoring of COPD patients while the
system is in use. The specific values of these loop parameters will
depend on design goals such as loop stability, overshoot,
time-to-achieve-control, and accuracy. Methods for obtaining values
which provide for effective operation of the control loop will be
known to those skilled in the art.
[0080] In one method, the control signal D(t.sub.n) is the dose
time needed to maintain the blood oxygen level at the desired
value. The dose time signal is provided by controller 10 to
respiration sensor/valve controller 42. It is the duration of time
that valve 26 will be held in the ON or open position which permits
oxygen to pass from supply 20 to patient 16 (via the supplemental
oxygen delivery device 18 illustrated in FIGS. 1 and 2). A dose of
oxygen of duration D(t.sub.n) is provided during inhalation (as
indicated by respiration sensor 40 and sensor and valve controller
42, described previously).
[0081] It should be understood that other methods besides varying
the dose time could also be employed to control the patient's blood
oxygen content. For example, a system which includes a
variable-flow valve (as opposed to the preferred open/closed valve)
could be constructed. In such a system, the controller 10 could
specify the oxygen flow level. The specified flow could, in turn,
be provided for a fixed period of time at the onset of each breath,
or continuously. During those times in which the patient does not
require supplemental oxygen and/or is not inhaling, the flow could
be restricted to a low level or to zero followed by periods in
which the flow is higher (when the patient is in need of supplement
oxygen and is inhaling).
[0082] Alternately, the blood oxygen content could be controlled by
providing a dose of oxygen on one or more sequential breaths and
then delivering no oxygen on one or more subsequent breaths. In
this method, the control parameter could be described as the number
of breaths during which oxygen is or is not delivered. It should be
understood that those skilled in the art could construct a control
scheme which uses any of these alternate methods or a combination
of these methods.
[0083] The controller 10 also may include a minimum limit (Dmin)
for the dose time. If the dose time D(t.sub.n), as determined by
Equation 2, is less than Dmin, a dose time of Dmin will be used
instead. In one embodiment, Dmin will be zero. The dose time
D(t.sub.n) determined by Equation 2 will, at times, be negative.
This will primarily occur when the patient's blood oxygen content
is greater than the desired value. Since a negative dose time is
not physically meaningful, the controller will instead substitute a
dose time of Dmin. Of course, Dmin could also be greater than
zero.
[0084] Similarly, in one embodiment the controller 10 would also
have a maximum limit (Dmax). If the dose time D(t.sub.n), as
determined by Equation 2, is greater than Dmax, a dose time of Dmax
is used instead. In one embodiment, Dmax is equal to twice the
default dose (described in detail below). This prevents the
application of excessive amounts of oxygen and thus minimizes the
patient's risk of hypercapnia (carbon-dioxide retention). Those
skilled in the art will appreciate that other values of Dmax could
also be used.
[0085] In another embodiment, the controller 10 could include an
"anti wind-up" provision. Because the dose time may have minimum
and maximum limits (Dmin and Dmax, described above), it may be
advantageous to include an anti wind-up provision to prevent the
integral portion of the PID-calculated dose time from getting too
large or too small. One way this could be implemented is as
follows: If the previous PID-calculated dose time D(t.sub.n-1)
(from Equations 2-7) is less than Dmin or greater than Dmax, the
integral term from Equation 3 is deleted (i.e., Equation 3 is
replaced with Equation 3a, below):
A.sub.0=K.sub.p*(1+t.sub.d/t.sub.n) (3a)
[0086] In systems and methods according to the present invention,
the ability to respond to periods of invalid or bad data in the
blood oxygen content measurements is preferably provided. In the
preferred methods and systems, the delivery of oxygen moves from
the closed loop control described herein to open loop control based
on the criteria described herein (i.e., default values,
interpolated data, etc.) and back to closed loop control when the
blood oxygen measurements are again valid. FIG. 4 illustrates these
concepts. As shown, the system obtains a measured blood oxygen
content level 120. A decision is then made as to whether the
measured blood oxygen content level data is valid or invalid 122.
The system may determine whether the measured blood oxygen content
level data is invalid on a point-by-point basis or it may determine
whether the data stream (including a plurality of data points) is
invalid as discussed below. Regardless, a decision will be made as
to whether the measured blood oxygen content level data is valid.
If the measured blood oxygen content level data is invalid, the
system will deliver a default amount of oxygen to the patient 124.
If the measured blood oxygen content level data is valid, the
system will deliver oxygen to the patient 126 according to the
appropriate control algorithm (ON/OFF, PID loop, etc.).
[0087] In other words, the methods/systems according to the present
invention will determine when the blood oxygen content data is
invalid, deliver a default amount of oxygen during periods of
invalid data, and then resume delivery of supplemental oxygen based
on blood oxygen content when that data is again valid. The ability
of the systems and methods of the present invention to move from
closed to open and back to closed loop control provides a robust
system that can operate with a minimum of supervision from medical
personnel. Those qualities are essential in any system designed for
residential or ambulatory use by sub-acute patients.
[0088] The following description illustrates some preferred methods
for accomplishing these features, but it should be understood that
in its essence the present invention provides for that movement
from closed loop control to open loop control and back to closed
loop control based on the presence of valid or invalid blood oxygen
content measurements.
[0089] In one embodiment, before the measured blood oxygen
saturation reading (SpO.sub.2) is used for determining the dose
time D of oxygen to be delivered to the patient 16 from the oxygen
source 20, various error handling and artifact detection procedures
are followed to prevent erroneous over- or under-dosing of oxygen
to the patient. In one embodiment of the present invention, the
error flags provided by the oxygen sensor 14 in the serial data
stream are combined with a numerical analysis of the SpO.sub.2 data
to create an artifact detection and handling scheme.
[0090] The serial data stream of the preferred pulse oximeter 14
provides one data point per second. Each data point includes three
bytes of information, as follows:
1 1st byte = Status Bit 7 = Always set to "1" Bit 6 = Sensor
disconnected, set if true Bit 5 = out of track, set if true Bit 4 =
low perfusion, set if true Bit 3 = marginal perfusion, set if true
Bit 2 = bad pulse, set if true Bit 1 = heart rate bit 8 Bit 0 =
heart rate bit 7 2nd byte = Heart Rate (511 = bad data) Bit "7" is
always set to "0" Heart Rate Data = Bits 0-6 Plus bits 0 & 1 of
status byte to provide 9 bits of resolution 3rd byte = SpO.sub.2
(127 = bad data)
[0091] The first byte of the data point may include error flags for
some problems associated with pulse oximetry. These flags are
examined for the occurrence of a disconnected sensor, low or
marginal perfusion, out of track oximeter and bad pulse. If any of
these flags are set, the accompanying SPO.sub.2 and heart rate data
is considered bad. If the data point is determined to be bad, a
timer (Timer1) is started by the controller 10 (unless it is
already running based on an earlier bad data point) which then
waits for the next data point. The function of Timer1 is to track
the cumulative time over which consecutive bad data points are
being received. Timer1 is stopped and reset to zero each time a
valid or good data point is received.
[0092] If, however, none of the flags is set, a second error check
may be performed using a statistical analysis of the data. The new
data point is compared to a mean value of previous data points
which represents the patient's current blood oxygen content. The
details of the calculation of this mean value are described below.
The current data point is subtracted from the mean value to
generate a difference, .DELTA.SpO.sub.2 in %. (For the
data-validity analysis below, if .DELTA.SpO.sub.2 is less than
zero, its absolute value is used.)
[0093] If the absolute value of .DELTA.SpO.sub.2>4% and Timer1
equals zero (i.e., the last data point was valid), then the current
data point is determined to be invalid. Since the time between data
points in the serial data stream will be about one second, a change
larger than 4 percent in the SpO.sub.02 in such a short time would
be physiologically impossible. If the data point is determined to
be invalid using this procedure, the data is ignored, Timer1 is
started and controller 10 waits for the next data point.
[0094] If, however, the absolute value of .DELTA.SpO.sub.2>4%
and Timer1 does not equal zero, then additional evaluation may be
performed. The observed rate of oxygen desaturation in humans can
approach 20%/minute or about 3% every 10 seconds. If Timer1 is less
than 10 seconds and the absolute value of .DELTA.SpO.sub.2>4%,
then the data is considered to be invalid. If Timer1 is greater
than 10 seconds, but less than 20 seconds then the acceptance
criteria is absolute value of .DELTA.SpO.sub.2 less than 8% for the
data to be valid. If Timer1 is greater than 20 seconds, but less
than 30 seconds then the acceptance criteria is absolute value of
.DELTA.SpO.sub.2 less than 12%. If Timer1 is greater than 30
seconds, then oxygen is delivered using the default method which is
described in detail below. It should, of course, be understood
that, in the above analysis, the specific values of 4%, 8%, and
12%, and the specific times of 10, 20 and 30 seconds could be
replaced with different values.
[0095] Some alternate criteria for identifying when individual data
points are invalid or bad could include, but are not limited to,
identifying an invalid data point when: (a) the SpO.sub.2 value is
outside upper and/or lower limits (e.g., a lower limit of about 70%
and/or an upper limit of about 98%); or (b) the heart rate is
outside upper and/or lower limits (e.g., a lower limit of about 40
beats per minute and/or an upper limit of about 200 beats per
minute).
[0096] If the data point passes all the tests, Timer1 is stopped
and set to zero (if necessary) and the new mean value of blood
oxygen content is calculated with the most recent data point. The
new mean value is then compared to the setpoint and a dose time D
is calculated as detailed above in Equations 2-5.
[0097] In one embodiment, an exponentially-weighted arithmetic mean
of the previous data points is used to represent the current blood
oxygen content. The new mean is calculated as follows:
new mean=(current data point)*W1+(previous mean)*W2 (6)
[0098] where
W1=1-exp (-.DELTA.t/T)W2=exp (-.DELTA.t/T) (7)
[0099] Here .DELTA.t is the time between data points (one second
using the preferred oximeter), and T is a parameter which
represents an appropriate time scale for the averaging. If an
appropriate value of T is chosen, the exponentially-weighted mean
will smooth out normal point-to-point "noise" fluctuations in the
pulse oximeter data without masking the real trends related to the
patient's blood oxygen content. (A typical value would be T=10
seconds, although other values could be used.)
[0100] Other methods could also be used to determine a mean value
that is representative of the patient's current blood oxygen
content. For example, a harmonic, or geometric mean might be used.
(Descriptions of these types of means can be found in "Standard
Mathematical Tables" by CRC Press, 24th edition, pages 470-471.)
Alternately, a "running" mean might be used. In this method, the
mean of a fixed, predetermined number of the most-recent data
points could be used. For example, with the preferred pulse
oximeter which delivers one data point per second, one could
average the preceding 10 data points, thus calculating a mean which
represents the patient's blood oxygen content for the previous 10
seconds.
[0101] In one embodiment, the dose time D of oxygen that is
delivered to the user may depend on the validity of the data stream
from the oxygen sensor. If the time over which the consecutive
invalid or bad data points are received, as indicated by Timer1,
exceeds a predetermined, physiologically-relevant time scale for
patient desaturation (referred to as Desattime), alternative,
"default" oxygen delivery procedures are employed. In one
embodiment Desattime is equal to 30 seconds. The default assumption
is that a patient is always in need of oxygen, unless the blood
oxygen content sensor positively indicates that they are not.
[0102] If the current oxygen sensor data point is invalid, but
Timer1 is less than Desattime, the oxygen dose time D may remain
unchanged from its current value. The system will provide a dose of
this duration at the onset of inhalation. The process of gathering
and evaluating blood oxygen saturation data then continues. Prior
to the onset of invalid data, the system was either administering
oxygen to correct a deficiency or the patient was in no need of
oxygen. Thus, in this embodiment it is assumed that the patient's
oxygen needs have not changed during this short time of invalid
data and the status quo is maintained. If the patient was receiving
no oxygen prior to the invalid data (e.g., dose time D=0), the
system will not administer any oxygen. If, however, the patient was
receiving oxygen (e.g., D>0), the system will typically continue
to administer the same dose by responding to inhalation as
described above. This will preferably continue until either a valid
data point is received and a reevaluation can be made of the
patient's condition or Timer1 exceeds Desattime.
[0103] If the oxygen sensor data points continue to be invalid and
Timer1 exceeds Desattime, then the device will default to another
oxygen delivery method. In the default method, the controller 10
will default to administering a prescription-equivalent dose of
oxygen to the patient 16 from the oxygen source 20 via the demand
delivery module 12. This default dose of oxygen could take many
forms: In one embodiment, the default could be a continuous flow of
oxygen. To implement this, the system could output a very large
dose time to hold valve 26 in the ON position which allows oxygen
to flow from source 20 to patient 16. Alternately, in the preferred
embodiment, the default mode would provide a short dose of oxygen
(of duration D=Ddefault) at the onset of inhalation for almost
every breath. In this preferred embodiment, Ddefault would be
shorter than a typical inhalation period, in which case the system
would provide pulses of duration Ddefault synchronized with each
inhalation (demand mode). This will continue until such time as the
blood oxygen content data is valid and closed-loop control over
oxygen delivery can start anew.
[0104] It is possible to envision additional alternate methods of
default flow. In one such alternate embodiment, the valve does not
necessarily open with each and every breath. It should be
understood that these alternate methods of implementing a default
flow still fall within the scope of the present invention. The
object of the default method is to provide a total flow of oxygen
during this period of default operation that is no less than the
physiological equivalent amount that is prescribed to the patient
by the physician. (Physiological equivalence meaning the amount
dispensed by other demand delivery devices to provide adequate
oxygen therapy.) It should be understood that the notion of
physiological equivalence as regards demand delivery devices will
change over time as their effects on the physiology of COPD
patients is better understood by the medical community. Current
practice indicates that 35 ml delivered every other breath at the
beginning of inhalation is equivalent to a continuous flow of 2
liters/minute of pure oxygen.
[0105] In one embodiment of the invention, the duration of the
default dose (Ddefault) may be set by the patient's respiratory
therapist using a hardware switch on the user interface 32 that is
not accessible to the patient. Other techniques of setting the
pulse width may be possible, such as a remote controllers, push
buttons, etc.
[0106] Also, in one embodiment, if Timer1 exceeds Desattime, then
the previous mean value of the blood oxygen saturation is reset and
data acquisition starts anew. In this way, it is assumed that the
old SpO.sub.2 information is no longer valid for the patient's
current physical state and that to properly administer oxygen a
more current measure of the blood oxygen level is needed. Thus, by
using Timer1, a period of invalid data that exceeds Desattime will
always lead to the administration of oxygen to the patient. This
will correct any undetected desaturation events. Moreover, the
controller 10 will always use the most current, valid information
regarding the patient's blood oxygen level.
[0107] It should also be understood that other methods for
recognizing and handling erroneous data points from the oxygen
sensor could be devised. Those skilled in the art could create
different algorithms for handling invalid data points, such as
replacement of invalid data points with interpolated values based
on the recent trend in the blood oxygen saturation. Alternative
methods of identifying and rejecting invalid data points should be
considered to be within the scope of the present method and
system.
[0108] Another method for determining whether the oxygen sensor
data is valid or invalid can be based on the data stream (a
plurality of data points) rather than the individual data points.
For example, instead of tracking the time since the most recent
valid data point or points, the system could instead determine if
the data stream is valid or invalid by comparing the number of
valid data points in a "look-back" window (for example, the 60 to
100 most recent data points) to a preset minimum threshold. If the
number of valid data points in the look-back period is greater than
or equal to the specified minimum, the data stream is considered to
be valid and the calculated dose is delivered; if the number of
valid data points is less than the minimum, the default dose is
delivered.
[0109] Those skilled in the art will understand that a wide range
of possibilities for oxygen delivery in default mode beyond those
that have been described here could be used. Although they are not
described in detail herein, they should be considered as falling
within the scope of the methods according to the present
invention.
[0110] If invalid data is a problem, the controller 10 may be used
to notify the patient of a problem with the pulse oximetry via the
user interface 32 and/or alarm 38. This notification may take the
form of a warning light, readout, buzzer or some combination of
these. Those skilled in the art may also conceive of other methods
of warning the user that are not detailed herein. After the
warnings have been issued and default demand flow mode entered, the
controller 10 resumes monitoring the output of the oxygen sensor
for valid data.
[0111] Along with monitoring the breathing cycle for oxygen
delivery, the invention makes provision for the detection of apnea,
the cessation of breathing for a prolonged period of time. Timer2
starts each time an inhalation is detected. If the elapsed time
between breaths is greater than a predetermined time, e.g., 15
seconds, as determined by Timer2, then the alarm circuit 38 is
activated by the controller 10 to signal the patient of a possible
apneic event. These alarms preferably stop sounding upon detection
of the next inhalation.
[0112] Other alarms and indicators that can be included in the
systems and methods of the present invention include hypoxia
alarms, high respiration rate alarms, high/low pulse rate alarms,
and patient monitoring indicators. These alarms and/or indicators
can be used to warn the patient that their supplemental oxygen
equipment is not operating properly, they are not using it
properly, or they are having other problems and need to seek
medical treatment.
[0113] In the case of an hypoxia alarm, the patient could be
provided with a visible and/or audible alert when their blood
oxygen saturation level has been below a healthy level for a period
of time--even though they have been using the above-described
device. This condition could be caused, e.g., by a malfunctioning
of the supplemental oxygen equipment or a worsening of the
patient's respiratory condition. In normal operation of the
preferred embodiment as described above, the device would increase
the dose time D(t) in response to the patient's hypoxia, up to a
preset upper-limit dose time Dmax. It is possible that the
patient's condition could have worsened so much so that even this
maximum dose is not sufficient to keep their blood oxygen
saturation at a healthy level. It would be advantageous to alert
the patient to this condition so they may seek appropriate medical
attention. This could enable earlier detection and treatment of
potentially dangerous and costly health conditions.
[0114] The hypoxia alarm could be implemented in software,
hardware, or in a combination of software and hardware. In the
methods described above, the controller 10 may already calculate a
mean value of blood oxygen content from the valid blood oxygen
saturation data points. In the preferred embodiment, the mean value
that is already calculated is an exponentially-weighted arithmetic
mean with a typical time constant T=10 seconds. This mean
represents the average blood oxygen saturation for the previous 10
seconds. For the hypoxia alarm, a second mean value of blood oxygen
saturation, for a longer period (e.g. T=1 hour) could be calculated
in an analogous manner. In the preferred embodiment, this hypoxia
alarm mean would also be an exponentially-weighted mean because it
eliminates the need to store each of the many data points that
would be collected over the longer period, thereby decreasing the
memory requirements.
[0115] It should be understood, however, that other methods of
calculating a mean as discussed above could also be used. When the
second mean falls below a preset limit representing the lower limit
for healthy blood oxygen levels (e.g., 88%), controller 10 could
alert the patient via alarm circuit 38. In the preferred
embodiment, the time period for the second mean is 1 hour, and the
lower limit for blood oxygen saturation is 88%; however, it should
be clear that other values could be used for these parameters.
[0116] In the case of a high respiration rate alarm, the patient
could be provided with a visible and/or audible alert when their
respiration rate has been above a healthy level for a period of
time. Some patients with respiratory diseases will compensate for
an impaired respiratory system by maintaining a higher than normal
breathing rate. These patients can sometimes maintain a healthy
blood oxygen saturation, but over the long term, the increased
respiration rate is also detrimental to their health. The onset of
a period of increased respiration rate could be caused by a
malfunctioning of the supplemental oxygen equipment or a worsening
of the patient's respiratory condition.
[0117] In normal operation of the preferred embodiment as described
above, the device increases the dose time D(t) in response to the
patient's hypoxia. It is possible that the patient's condition
could have worsened, but the patient is compensating by breathing
at a higher rate. As with hypoxia, it would be advantageous to
alert the patient to this condition so they may seek appropriate
medical attention.
[0118] This alarm could be implemented in software, hardware, or in
a combination of software and hardware. The system described above
already measures the elapsed time between each breath via Timer2.
For the high-respiration rate alarm, a mean value of the elapsed
time between each breath could be calculated in a manner analogous
to the mean blood oxygen levels. In the preferred embodiment, this
mean would also be an exponentially-weighted mean. It should be
understood, however, that other methods of calculating a mean as
described above could also be used. When the mean elapsed time
between breaths falls below a preset limit corresponding to the
upper limit for healthy respiration rates (e.g., minimum elapsed
time of two seconds, corresponding to a breathing rate of 30
breaths per minute), the system could alert the patient via
controller 10 and alarm circuit 38. In the preferred embodiment,
the time period for calculating the mean is 1 hour, and the lower
limit for elapsed time between breaths is 2 seconds (30 breaths per
minute); however, it should be clear that other values could be
used for these parameters.
[0119] In the case of a high/low pulse rate alarm, a visible and/or
audible alert could be provided to the patient when their pulse
rate has been above or below healthy levels for a period of time.
Excessively high or low pulse rates could be an important
indication that the patient needs medical treatment. It would be
advantageous to alert the patient to these conditions so they may
seek appropriate medical attention.
[0120] In the preferred embodiment, these alarms would be
implemented in software, hardware, or in a combination of software
and hardware. The preferred oxygen sensor typically provides pulse
rate data (in addition to blood oxygen data). A mean pulse rate
could be calculated in a manner analogous to the calculation of
other means, described above. As with the other alarms, in the
preferred embodiment, this mean would also be an
exponentially-weighted mean or, alternatively, other means or
averages could be used.
[0121] When the mean pulse rate falls above or below preset limits
(e.g., less than 40 or above 180 beats per minute), the system
could alert the patient via alarm circuit 38. In the preferred
embodiment, the time period for the mean is 20 minutes, the lower
limit for pulse rate is 40 beats per minute, and the upper limit
for pulse rate is 180 beats per minute; however, it should be clear
that other values could be used for these parameters.
[0122] Among the indicators that could be provided include various
patient and equipment monitoring functions. In the preferred
embodiment, these indicators could be implemented in software,
hardware, or in a combination of software and hardware. The
information provided by these indicators could be useful to the
patients, respiratory therapists, physicians, etc. Some examples of
indicators are described below.
[0123] One indicator that could be useful is an "ON-time"
indicator. An important factor in treating patients that require
supplemental oxygen is monitoring their compliance with their
oxygen prescription. Some patients will not use their oxygen
equipment as much as they should. Medical studies have shown that
most patients must use their supplemental oxygen equipment at least
18 hours per day in order to receive significant benefits from it.
The ON-time parameter would indicate the total amount of time that
the device has been powered ON (analogous to the "hour meter" found
on most oxygen concentrators), thus giving an indication of the
total time the equipment was used since the ON-time parameter was
last reset to zero. In the preferred embodiment, a timer would be
started by controller 10 each time the unit was turned ON. When
timer reached a value of, e.g., one minute, controller 10 would
increment a non-volatile memory location and reset and restart the
timer. In this manner, a memory location associated with the
ON-time timer would count the number of minutes the apparatus had
been powered ON. The memory location associated with the ON-time
timer would preferably be non-volatile and, as a result, the total
minute count would be retained while the unit was powered OFF. When
powered ON again, counting would resume from the previously
accumulated value. In the preferred embodiment, the ON-time timer
could be accessed and reset via the user interface 32.
[0124] It may also be useful to track the total number of times
each alarm condition has occurred. In the preferred embodiment, a
separate non-volatile memory location would be used to count the
number of times each alarm condition had occurred. Each time an
alarm condition occurred, the associated memory location would be
incremented. In addition to the three alarms described above, the
preferred embodiment could also count the number of apnea alarms.
The various alarm-count parameters could be accessed and reset,
e.g., via the user interface 32.
[0125] It may also be useful to keep track of the total amount of
time the unit was in "default" mode as described above. In a manner
similar to tracking ON-time, the default time monitor would
preferably consist of a non-volatile memory location that would be
incremented each time the timer reached one minute and the unit was
in the default mode. In a similar manner, a feedback-control-time
parameter could be calculated (although this parameter may be more
easily obtained by subtracting the default time from the ON-time).
As with the other monitored parameters, default time would
preferably be accessed and reset via the user interface 32.
[0126] It may also be useful to keep track of the total number of
times the apparatus entered the "default" mode. In the preferred
embodiment, a separate non-volatile memory location would be used
to count the number of times the default delivery condition had
occurred. Each time the apparatus entered the default delivery
mode, the associated memory location would be incremented. The
default count parameter would preferably be accessed and reset via
the user interface 32.
[0127] It may also be useful to keep track of the total amount of
time the patient was hypoxic (e.g., SpO.sub.2<88%). In a manner
similar to tracking the ON-time, the hypoxic-time monitor would
consist of a non-volatile memory location that would be incremented
each time the timer reached one minute and the patient was hypoxic
(and the SpO.sub.2 data was deemed valid). As with the other
monitored parameters, hypoxic-time could be accessed and reset via
the user interface 32.
[0128] It may also be useful to keep track of the average duration
of the pulses of oxygen that are provided at each inhalation (i.e.,
the average dose time). The average-dose-time parameter could
provide a useful indication of the amount of supplemental oxygen
that was required to keep the patient's blood properly oxygenated.
Trends in this parameter could be useful for tracking the overall
efficiency of the patient's respiratory condition. For example, a
measurable increase in the average-dose-time (i.e., an increase in
the amount of supplemental oxygen needed) could indicated a
worsening of the patient's condition, and thus provide an early
warning allowing the patient to seek medical attention before their
condition required a costly hospitalization.
[0129] In the preferred embodiment, two nonvolatile memory
locations would be used to calculate average-dose-time: a counter
and an accumulator. Each time, e.g., an inhalation was sensed, the
current dose time (as indicated by controller 10) would be added to
accumulator and the counter would be incremented. The
average-dose-time could then be calculated by dividing the
accumulator value by the counter value. As with the other monitored
parameters, average-dose-time could be accessed and reset via the
user interface 32.
[0130] In addition to those parameters specifically recited herein,
other useful parameters may also be generated. For example, average
SpO.sub.2 (the patient's average blood oxygen saturation); average
respiration rate; average heart rate; etc. Monitoring of these
parameters could also be implemented in software, hardware, or in a
combination of software and hardware.
[0131] Various methods and systems for conserving supplemental
oxygen delivery to a sub-acute patient based on continuous blood
oxygen content measurements and inhalation have been described
above. Many changes, alterations and variations of the subject
invention will become apparent to those skilled in the art after
consideration of this specification and the accompanying figures
and diagrams of the preferred embodiments. For example, the values
chosen for, e.g., .DELTA.SpO.sub.2, Timer1, Timer2, etc., are
intended to be exemplary of some preferred values and should not
limit the scope of the invention unless the values are explicitly
recited in the claims. All such changes, modifications, variations,
etc. are deemed to be covered by the claims which follow.
* * * * *