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Improvements Relating To Respiratory Support

Abstract: Described is a method of (and apparatus for) assessing a patient receiving respiratory support during a session to determine a respiratory status comprising: receiving from one or more sensors, for a plurality of time points, one or more patient parameters for a patient, comprising at least one respiratory parameter, determining in a controller: for each time point, a respiratory index from the one or more patient parameters, and a change in respiratory index over time, and determining, from the change in respiratory index over time, a patient respiratory status.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
01 February 2023
Publication Number
42/2023
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
Parent Application

Applicants

FISHER & PAYKEL HEALTHCARE LIMITED
15 Maurice Paykel Place East Tamaki Auckland 2013

Inventors

1. TATKOV, Stanislav
15 Maurice Paykel Place East Tamaki Auckland 2013

Specification

FIELD OF THE INVENTION
5 The present disclosure relates to apparatus, systems and/or methods for using a respiratory
index to determine aspects of respiration, including but not limited to respiratory index
respiratory status and/or changes in respiratory support (e.g. based on respiratory index
and/or status).
10 BACKGROUND TO INVENTION
15
20
High flow respiratory support has become popular and is commonly used. It has become a
front-line therapy for patients with respiratory distress. High flow respiratory support is also
used to assist patients whose respiratory systems are compromised (including patients with
conditions such as COPD, pulmonary fibrosis, asthma etc).
High flow respiratory support can be an oxygenation tool for patients with respiratory
distress or failure. Further, it can increase the amount of 02 delivered due to the fact that
high flows can prevent the entrainment of room air. However, high 02 fraction (high Fi02)
can potentially mask deterioration of the patient and delay escalation of care.
Patients can be escalated to e.g. mechanical ventilation or non-invasive ventilation. The risk
of invasive mechanical ventilation is well understood, although delaying ventilation can
result in a lengthened hospital stay and increased mortality.
25 Therefore, it is desirable to determine when to escalate respiratory support. It can further
be desirable to determine a patient's respiratory status to enable a clinician to make better
decisions for patients.
30
SUMMARY OF INVENTION
In one aspect the present disclosure may be said to comprise a method of assessing a
patient receiving NHF respiratory support, and where necessary changing the respiratory
support based on the assessment, comprising: receiving from one or more sensors over one
or more patient parameters for a patient, comprising at least an oxygenation parameter,
35 determining in a controller a respiratory index at a plurality of times, and determining from
a trend in respiratory index over time whether a change in respiratory support is required,
and if so, making a change in respiratory support.
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In another aspect the present disclosure may be said to comprise a method of treating a
patient with a respiratory support apparatus comprising receiving from one or more sensors
over one or more patient parameters for a patient, comprising at least an oxygenation
5 parameter, determining in a controller a respiratory index at a plurality of times, and
determining from a trend in respiratory index over time whether a change in respiratory
support is required, and if so, making a change in respiratory support.
10
Optionally the respiratory index is ROX index.
Optionally the respiratory index is determined from one or more lung mechanics parameters
and one or more oxygenation parameters.
Optionally a lung mechanics parameter is a parameter that indicates lung mechanics, such
15 as respiratory rate, expiratory time, minute ventilation).
Optionally a oxygenation parameter/oxygenation exchange parameter is a parameter that
indicates oxygenation, such as Sp02, Fi02, Fd02, 02 fraction ... While different, Fi02, Fd02
and 02 fraction can be approximate proxy measurements for each other and can be used
20 interchangeably where appropriate.
Optionally the assessment phase can comprise one or more of:
• assessing the respiratory status, and determining whether it is normal, abnormal,
deteriorating, stable, improving or the like,
25 • assessing whether a change in respiratory support is required (as a result of
30
assessing the respiratory status),
• if the changes required, assessing what change in respiratory support is required
(e.g. escalation, de-escalation, increasing or decreasing high flow therapy, escalating
to NIV or invasive ventilation, deescalating from NIV or invasive ventilation or the
like)
Optionally the change in respiratory support phase can comprise:
• indicating any of the above outcomes of the assessment phase, e.g. by alerts,
alarms, messages or other indicators, and/or
35 • making any of the changes determined in the assessment phase.
Optionally the assessment phase could be implemented:
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• by a clinician alone,
• one or more assessment, therapy and/or other apparatus without a clinician,
• or both the clinician and one or more apparatus.
5 Optionally the respiratory support phase could be implemented:
• by a clinician alone,
• one or more assessment, therapy and/or other apparatus without a clinician,
• or both the clinician and one or more apparatus.
10 In another aspect the present disclosure may be said to comprise a method of assessing a
patient receiving respiratory support during a session to determine a respiratory status
comprising: receiving from one or more sensors, for a plurality of time points, one or more
patient parameters for a patient, comprising at least one respiratory parameter,
determining in a controller: for each time point, a respiratory index and/or one or more
15 component parameters, from the one or more patient parameters, and a change in
respiratory index and/or one or more component parameters over time, and determining,
from the change in respiratory index and/or one or more component parameters over time,
a patient respiratory status.
20 Optionally the patient is receiving respiratory support, and optionally the respiratory support
is: high flow respiratory support, non-invasive pressure respiratory support.

Claims
1. A method of assessing a patient receiving respiratory support during a session to
determine a respiratory status comprising:
receiving from one or more sensors, for a plurality of time points, one or more
5 patient parameters for a patient, comprising at least one respiratory parameter,
10
15
20
determining in a controller:
for each time point, a respiratory index from the one or more patient
parameters, and
a change in respiratory index over time, and
determining, from the change in respiratory index over time, a patient
respiratory status.
2. A method according to claim 1 wherein the patient is receiving respiratory support,
and optionally the respiratory support is:
3.
high flow respiratory support,
A method according to claim 1 or 2 wherein the session:
is a treatment session,
a day or part thereof,
a night or part thereof,
sub-sessions,
a length of time.
4. A method according to any preceding claim wherein the one or more patient
25 parameters are one or more lung mechanics parameters and one or more oxygenation
para meters.
5. A method according to claim 4 wherein a lung mechanics parameter can be one or
more of:
30 • Respiratory rate
• Expiratory time
• Minute ventilation
6. A method according to claim 4 or 5 wherein a oxygenation parameter can be one or
35 more of:
• Fi02
• Fd02
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• 02 fraction
• Sp02
7. A method according to any preceding claims wherein the respiratory index is ROX
5 index.
10
15
8. A method according to claim 7 wherein components of the ROX index are:
respiratory rate,
Sp02, and/or
Fi02, Fd02, and/or 02 fraction.
9. A method according to claim 5 or 8 wherein a respiratory rate is determined by the
controller from one or more patient parameters received from the one or more sensors.
10. A method according to any preceding claim further comprising indicating and/or
making a change in respiratory support based on the respiratory status and/or respiratory
index.
11. A method according to any preceding claim comprising displaying ROX index
20 numerically and/or graphically.
12. A method according to any preceding claim wherein determining a change in
respiratory index over time comprises:
for a plurality of time points, determining a change in respiratory index over time for
25 each of the plurality of time points.
30
35
13. A method according to claim 11 or 12 further comprising displaying, for the plurality
of time points, the change in respiratory index over time for each of the plurality of time
points.
14. A method according to claim 11, 12 or 13 wherein determining a patient respiratory
status from the change in respiratory index over time comprises monitoring a change, over
the plurality of points in time, of the change in respiratory index over time.
15. A method according to claim 14 wherein monitoring a change, over the plurality of
time points, of the change in respiratory index over time comprises, for the plurality of time
points:
5
10
15
20
25
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viewing the displayed change, over the plurality of points in time, of the change in
respiratory index over time ,and/or
calculating and comparing the change to relationship information
16. A method according to any one of claims 11 to 15 further comprising displaying a
respiratory index threshold and/or change indicator threshold.
17. A method according to any preceding claim wherein determining a change in
respiratory index over time comprises determining a trend in the respiratory index.
18. A method according to claim 17 wherein the trend comprises a plurality of
instantaneous trends, and determining a trend comprises determining a plurality of
instantaneous trends over time.
19. A method according to claim 17 or 18 wherein a trend or an instantaneous trend is
represented with a trend parameter comprising magnitude and a direction, and optionally
could be in the form of:
a vector, or
a slope and magnitude.
20. A method according to any preceding claim further comprising communicating the
determined change in respiratory support to:
a clinician, for example in the form of a message, alarm, respiratory status,
respiratory index, and/or
a respiratory support apparatus.
21. A method according to any previous claim wherein the one or more sensors
comprise:
one or more sensors arranged to sense a flow path of a respiratory support
30 apparatus, and/or
35
one or more sensors arranged to sense parameters of a patient,
and
the controller receives the one or more patient parameters from the one or more
sensors.
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22. A method according to any preceding claim further comprising displaying on an
interface, either on a respiratory apparatus, mobile device and/or other assessment
apparatus one or more of:
the respiratory index versus time, either graphically and/or numerically,
5 one or more components of the respiratory index (e.g. respiratory rate, Sp02, Fi02
or the like), alone, combined and/or options versus time, either graphically and/or
numerically, and/or
one or more vectors, slopes, angles, magnitudes, differences and/or other change
indicators indicating change between two or more respiratory indexes and/or components
10 thereof, over time or otherwise.
23. A method according to claim 22 further comprising receiving input (e.g. user input)
to revise the display and re-displaying information based on the user input, comprising one
or more of:
15 receiving input to display one or more components of the respiratory index, and
displaying the one or more components of the respiratory index alone, combined and/or
options versus time, either graphically and/or numerically, and/or
receiving input to display, zoom and/or move the display, and displaying, or
redisplaying a zoomed and/or moved version of:
20 respiratory index (e.g. ROX index) versus time, either graphically and/or
25
numerically,
one or more components of the respiratory index, alone, combined and/or
options versus time, either graphically and/or numerically, and/or
one or more vectors, slopes, angles, magnitudes, differences and/or other
change indicators indicating change between two or more respiratory indexes and/or
components thereof, over time or otherwise.
24. A method according to claim 22 or 23 wherein a clinician determines a patient
respiratory status from a change in respiratory index over time by viewing
30 the respiratory index (e.g. ROX index) versus time, either graphically and/or
numerically,
one or more components of the respiratory index (e.g. respiratory rate, Sp02, Fi02
or the like), alone, combined and/or options versus time, either graphically and/or
numerically, and/or
35 one or more vectors, slopes, angles, magnitudes, differences and/or other change
indicators indicating change between two or more respiratory indexes and/or components
thereof, over time or otherwise.
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25. A method according to any preceding claim wherein a clinician determines a patient
respiratory status from a change in respiratory index over time by any one or a combination
of the following:
5 comparing one or more respiratory index( es) and/or a change in respiratory index,
relative to one or more threshold(s),
comparing one or more change indicators relative to one or more threshold(s),
comparing one or more respiratory index( es) and/or a change in respiratory index,
relative to one or more other respiratory index(es) and/or a change in respiratory index
10 and/or relative to one or more other one or more change indicators,
15
comparing one or more change indicators relative to one or more other change
indicators and/or one or more respiratory index(es) and/or a change in respiratory index,
considering one or more:
respiratory indexes,
change in respiratory indexes over time,
change in, change in respiratory indexes over time, and/or
change indicators.
26. A method according to any preceding claim wherein upon determining a patient
20 respiratory status, one or more of the following can occur to indicate respiratory status:
25
an alarm is sounded and/or a message is displayed, which indicate the respiratory
status, alert the clinician and/or indicate action required, and/or
a change in therapy is actioned, automatically and/or manually.
27. An apparatus for assessing a patient receiving respiratory support during a session
to determine a respiratory status comprising:
one or more sensors, or inputs for one or more sensors for receiving from for a
plurality of time points, one or more patient parameters for a patient, comprising at least
one respiratory parameter,
30 a controller for determining:
35
for each time point, a respiratory index from the one or more patient
parameters, and
determining, from the change in respiratory index over time, a patient
respiratory status, and/or
displaying on a display a change in respiratory index over time for a user to
determine a patient respiratory status.
5
10
15
20
25
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28. An apparatus according to claim 27 wherein the patient is receiving respiratory
support, and optionally the respiratory support is:
29.
30.
high flow respiratory support.
An apparatus according to claim 27 or 28 wherein:
the assessment apparatus provides the respiratory support, or
the assessment apparatus is separate to a respiratory support apparatus.
An apparatus according to claim 27, 28 or 29 wherein the session:
is a treatment session,
a day or part thereof,
a night or part thereof,
sub-sessions,
a length of time.
31. An apparatus according to any one of claims 27 to 30 wherein the one or more
patient parameters are one or more lung mechanics parameters and one or more
oxygenation parameters.
32. An apparatus according to claim 31 wherein a lung mechanics parameter can be one
or more of:
• Respiratory rate
• Expiratory time
• Minute ventilation
33. An apparatus according to claim 31 or 32 wherein a oxygenation parameter can be
one or more of:
• Fi02
• Fd02
30 • 02 fraction
• Sp02
35
34. An apparatus according any one of claims 27 to 33 wherein the respiratory index is
ROX index.
35. An apparatus according to claim 34 wherein components of the ROX index are:
respiratory rate,
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Sp02, and/or
Fi02, Fd02, and/or 02 fraction.
36. An apparatus according to claim 35 wherein a respiratory rate is determined by the
5 controller from one or more patient parameters received from the one or more sensors.
37. An apparatus according any one of claims 27 to 36 wherein the respiratory index is
ROX index, determined from respiratory rate, Fi02 and/or Sp02 .
10 38. An apparatus according any one of claims 27 to 37 comprising displaying ROX index
numerically and/or graphically on the display.
39. A apparatus according any one of claims 27 to 38 wherein determining a change in
respiratory index over time comprises:
15 for a plurality of time points, determining a change in respiratory index over time for
each of the plurality of time points.
40. A apparatus according to claim 39 further comprising displaying, for the plurality of
time points, the change in respiratory index over time for each of the plurality of time
20 points.
41. An apparatus according to claim 40 wherein determining from the change in
respiratory index over time, comprises the controller calculating and comparing the change
25 to relationship information.
30
42. An apparatus according to any one of claims 27 to 41 further comprising the
controller displaying:
a respiratory index threshold and/or change indicator threshold.
43. An apparatus according any one of claims 27 to 42 further comprising
communicating the determined change in respiratory support to:
a clinician, for example in the form of a message, alarm, respiratory status,
respiratory index, and/or
35 a respiratory support apparatus.
5
10
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44. An apparatus according any one of claims 27 to 43 wherein the one or more sensors
comprise:
one or more sensors arranged to sense a flow path of a respiratory support
apparatus, and/or
one or more sensors arranged to sense parameters of a patient,
and
the controller receives the one or more patient parameters from the one or more
sensors.
45. An apparatus according any one of claims 27 to 44 wherein the apparatus is one or
more of a:
respiratory apparatus,
mobile device,
a remote monitoring system,
15 either alone or integrated.
46. An apparatus according to any one of claims 27 to 45 comprising the sensors.
47. A system for assessing a patient receiving respiratory support during a session to
20 determine a respiratory status comprising:
An apparatus according to any one of claims 27 to 46 carrying out a method
according to any one of claims 1 to 26.

Documents

Application Documents

# Name Date
1 202317006606.pdf 2023-02-01
2 202317006606-TRANSLATIOIN OF PRIOIRTY DOCUMENTS ETC. [01-02-2023(online)].pdf 2023-02-01
3 202317006606-STATEMENT OF UNDERTAKING (FORM 3) [01-02-2023(online)].pdf 2023-02-01
4 202317006606-FORM 1 [01-02-2023(online)].pdf 2023-02-01
5 202317006606-DRAWINGS [01-02-2023(online)].pdf 2023-02-01
6 202317006606-DECLARATION OF INVENTORSHIP (FORM 5) [01-02-2023(online)].pdf 2023-02-01
7 202317006606-COMPLETE SPECIFICATION [01-02-2023(online)].pdf 2023-02-01
8 202317006606-FORM-26 [01-04-2023(online)].pdf 2023-04-01
9 202317006606-Proof of Right [14-07-2023(online)].pdf 2023-07-14
10 202317006606-FORM 3 [14-07-2023(online)].pdf 2023-07-14
11 202317006606-FORM 18 [29-05-2024(online)].pdf 2024-05-29