U.S. patent application number 15/794838 was filed with the patent office on 2018-04-19 for fluid titration system.
The applicant listed for this patent is MASIMO CORPORATION. Invention is credited to Massi Joe E. Kiani.
Application Number | 20180103905 15/794838 |
Document ID | / |
Family ID | 40455351 |
Filed Date | 2018-04-19 |
United States Patent
Application |
20180103905 |
Kind Code |
A1 |
Kiani; Massi Joe E. |
April 19, 2018 |
FLUID TITRATION SYSTEM
Abstract
A fluid titration system has an optical sensor, a physiological
monitor, a titration controller and an infusion device. The optical
sensor transmits multiple wavelengths of light into a tissue site
of a person and detects the optical radiation after attenuation by
pulsatile blood flowing within the tissue site. The physiological
monitor receives a resulting sensor signal and derives a
plethysmograph that corresponds to the pulsatile blood flow. The
monitor also calculates a plethysmograph variability measure that
is responsive to changes in perfusion at the tissue site. A
titration controller generates a fluid control output according to
the variability measure. The infusion device administers a liquid
solution via an intravenous (IV) connection to the person according
to the fluid control output so as to regulate at least one of a
fluid flow start, rate and stop.
Inventors: |
Kiani; Massi Joe E.; (Laguna
Niguel, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MASIMO CORPORATION |
Irvine |
CA |
US |
|
|
Family ID: |
40455351 |
Appl. No.: |
15/794838 |
Filed: |
October 26, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13287060 |
Nov 1, 2011 |
9820691 |
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15794838 |
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12208998 |
Sep 11, 2008 |
8048040 |
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13287060 |
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60993584 |
Sep 13, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/14551 20130101;
A61M 2205/3313 20130101; A61M 2205/3306 20130101; A61B 5/6826
20130101; A61M 5/142 20130101; A61B 5/0295 20130101; A61B 5/6838
20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61M 5/142 20060101 A61M005/142; A61B 5/1455 20060101
A61B005/1455; A61B 5/0295 20060101 A61B005/0295 |
Claims
1-19. (canceled)
20. A method of managing a blood volume of a patient, the method
comprising: noninvasively detecting, with a detector of an optical
sensor, light attenuated by tissue of the patient at a measurement
site; outputting, with the optical sensor, a signal responsive to
the light; determining, with one or more hardware processors, a
first measure of variability from at least a ratio of a pulsatile
component to a nonpulsatile component of the signal, the pulsatile
component and the nonpulsatile component being indicative of a
blood volume in the tissue, the pulsatile component being
responsive to variable absorption and the nonpulsatile component
being responsive to static absorption; determining, with the one or
more hardware processors, that the first measure of variability
indicates a need for the patient to receive a liquid solution; and
in response to determining that the first measure of variability
indicates the need, outputting a first infusion indication for
presentation to a caregiver, the first infusion indication
indicating to administer the liquid solution to the patient.
21. The method of claim 20, further comprising: determining, with
the one or more hardware processors, a second measure of
variability from at least the ratio of the pulsatile component to
the nonpulsatile component of the signal at a first time, the first
time being different from a second time at which the first measure
of variability is determined; determining, with the one or more
hardware processors, that the second measure of variability does
not indicate the need; and in response to determining that the
second measure of variability does not indicate the need,
outputting a second infusion indication for presentation to the
caregiver, the second infusion indication indicating not to
administer the liquid solution to the patient.
22. The method of claim 21, further comprising visually presenting
the first infusion indication and the second infusion indication to
the caregiver on a display.
23. The method of claim 21, further comprising: visually presenting
the first infusion indication to the caregiver on a display as +,
on, increase, or start; and visually presenting the second infusion
indication to the caregiver on the display as -, off, decrease, or
stop.
24. The method of claim 21, further comprising audibly presenting
the first infusion indication and the second infusion indication to
the caregiver.
25. The method of claim 21, further comprising: comparing the first
measure of variability with a threshold to determine whether the
first measure of variability indicates the need; and comparing the
second measure of variability with the threshold to determine
whether the second measure of variability indicates the need.
26. The method of claim 20, further comprising visually presenting
the first infusion indication to the caregiver on a display as +,
on, increase, or start.
27. The method of claim 20, wherein the first measure of
variability is responsive to a dehydration condition of the
patient.
28. The method of claim 20, wherein the first measure of
variability is responsive to a hemorrhaging condition of the
patient.
29. The method of claim 20, wherein the liquid solution comprises
blood products.
30. The method of claim 20, wherein the liquid solution comprises
nutrient fluids.
31. The method of claim 20, further comprising administering the
liquid solution to the patient subsequent to said outputting the
first infusion indication for presentation to the caregiver.
32. The method of claim 31, wherein said administering the liquid
solution to the patient is performed using an infusion device
separate from a patient monitor comprising the one or more hardware
processors.
33. The method of claim 20, further comprising comparing the first
measure of variability with a threshold to determine whether the
first measure of variability indicates the need.
34. The method of claim 20, wherein said determining the first
measure of variability comprises processing a respiration-induced
cyclical variation in the signal.
35. The method of claim 20, wherein said determining the first
measure of variability comprises determining the first measure of
variability from at least a change in the ratio of the pulsatile
component to the nonpulsatile component.
36. The method of claim 20, wherein the first measure of
variability comprises a measure of perfusion index variability of
the signal.
37. The method of claim 20, further comprising irradiating, with
one or more emitters of the optical sensor, the tissue with red and
infrared wavelengths.
38. The method of claim 20, wherein the measurement site comprises
a finger.
39. The method of claim 20, further comprising determining, with
the one or more hardware processors, a parameter measurement from
the signal, the parameter measurement comprising carboxyhemoglobin
or methemoblobin.
Description
REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority benefit under 35
U.S.C. .sctn. 120 to, and is a continuation of U.S. patent
application Ser. No. 13/287,060, filed on Nov. 1, 2011, entitled
"Fluid Titration System," which is a continuation of U.S. patent
application Ser. No. 12/208,998, filed on Sep. 11, 2008, entitled
"Fluid Titration System," now U.S. Pat. No. 8,048,040, which claims
priority benefit under 35 U.S.C. .sctn. 119(e) from U.S.
Provisional Application No. 60/993,584, filed Sep. 13, 2007,
entitled "Fluid Titration System;" the disclosures of which are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] FIG. 1 illustrates a physiological monitoring system 100
having a physiological monitor 120, a noninvasive sensor 130
attached to a tissue site 1, and a sensor cable 140 interconnecting
the monitor 120 and the sensor 130. Physiological monitoring
systems for measuring constituents of circulating blood have gained
rapid acceptance in a wide variety of medical applications,
including surgical wards, intensive care and neonatal units,
general wards, home care, physical training, and virtually all
types of monitoring scenarios. The noninvasive sensor 130 has light
emitting diodes (LEDs) and a detector. The LEDs transmit optical
radiation into the tissue site 1, and the detector responds to the
intensity of the optical radiation after absorption by pulsatile
blood flow within the tissue site. Based upon this response, the
physiological monitor 120 determines measurements for physiological
parameters. The physiological monitoring system 100 may incorporate
pulse oximetry, which is a widely accepted noninvasive procedure
for measuring physiological parameters, such as oxygen saturation
and pulse rate among others. The physiological monitoring system
100 may also incorporate advanced features, such as a multiple
wavelength sensor and advanced processes for determining other
physiological parameters, such as carboxyhemoglobin, methemoglobin
and total hemoglobin, as a few examples. The physiological monitor
120 displays the physiological parameters and typically provides
visual and audible alarm mechanisms that alert a caregiver when
these parameters are outside of predetermined limits.
[0003] Pulse oximeters capable of reading through motion induced
noise are disclosed in at least U.S. Pat. Nos. 6,770,028,
6,658,276, 6,650,917, 6,157,850, 6,002,952, 5,769,785, and
5,758,644; low noise pulse oximetry sensors are disclosed in at
least U.S. Pat. Nos. 6,088,607 and 5,782,757; all of which are
assigned to Masimo Corporation, Irvine, Calif. ("Masimo") and are
incorporated by reference herein.
[0004] Physiological monitors and corresponding multiple wavelength
optical sensors are described in at least U.S. patent application
Ser. No. 11/367,013, filed Mar. 1, 2006 and entitled Multiple
Wavelength Sensor Emitters and U.S. patent application Ser. No.
11/366,208 [Ser. No. 11,367,033], filed Mar. 1, 2006 and entitled
Noninvasive Multi-Parameter Patient Monitor, both assigned to
Masimo Laboratories, Irvine, Calif. (Masimo Labs) and both
incorporated by reference herein.
[0005] Further, physiological monitoring systems that include low
noise optical sensors and pulse oximetry monitors, such as any of
LNOP.RTM. adhesive or reusable sensors, SofTouch.TM. sensors, Hi-Fi
Trauma.TM. or BIue.TM. sensors; and any of Radical.RTM.,
SatShare.TM., Rad-9.TM., Rad-S.TM., Rad-5v.TM. or PPO+.TM. Masimo
SET.RTM. pulse oximeters, are all available from Masimo.
Physiological monitoring systems including multiple wavelength
sensors and corresponding noninvasive blood parameter monitors,
such as Rainbow.TM. adhesive and reusable sensors and RAD-57.TM.
and Radical7.TM. monitors for measuring SpO.sub.2, pulse rate,
perfusion index, signal quality, HbCO and HbMet among other
parameters are also available from Masimo.
[0006] FIG. 2 illustrates the standard plethysmograph waveform 200,
which can be derived from a pulse oximetry system, as described
above. The plethysmograph waveform 200 illustrates light absorption
at the tissue site, shown along the y-axis 10, versus time, shown
along the x-axis 20. The total absorption includes components of
static absorption 210 and variable absorption 220. Static
absorption 210 is due to tissue, venous blood and a base volume of
arterial blood. Variable absorption 220 is due to the pulse-added
volume of arterial blood. That is, the plethysmograph waveform 200
is a visualization of the tissue site arterial blood volume change
over time, and is a function of heart stroke volume, pressure
gradient, arterial elasticity and peripheral resistance. The ideal
waveform pulse 230 displays a broad peripheral flow curve, with a
short, steep inflow phase 232 followed by a 3 to 4 times longer
outflow phase 234. The inflow phase 232 is the result of tissue
distention by the rapid blood volume inflow during ventricular
systole. During the outflow phase 234, blood flow continues into
the vascular bed during diastole. The plethysmograph baseline 240
indicates the minimum basal tissue perfusion.
SUMMARY OF THE INVENTION
[0007] FIG. 3 illustrates a hypovolemic plethysmograph waveform
300, i.e. a plethysmograph displaying characteristics of a person
having an abnormal decrease in blood volume. Hypovolemia is often
caused from blood loss during surgery or due to an injury. Under
hypovolemic conditions, a respiration-induced cyclical variation
occurs in a plethysmograph baseline 340. In particular, the
baseline 340 varies with a period corresponding to the respiration
rate 350. This cyclical variation is particularly evident in
patients undergoing positive ventilation. The amount of cyclical
variation correlates to a person's blood volume, i.e. the less
blood volume the greater the cyclical variation in the
plethysmograph waveform. Accordingly, a measure of plethysmograph
variation may be indicative of hypovolemic conditions.
[0008] FIG. 4 illustrates a plethysmograph 400 plotted on an
amplitude axis 30 versus a time axis 40. As described above, the
amplitude may be responsive to light absorption of pulsatile blood
flow with a person's tissue. The plethysmograph 400 has multiple
pulses 460 each with a peak 462 and a valley 464 and extending over
a time period 466. A perfusion index (PI) value can be defined for
each pulse 460:
PI=AC/DC (1)
where "AC" 454 designates a peak amplitude 462 minus a valley
amplitude 464 for a particular pulse and where "DC" 456 designates
a peak amplitude 462 for a particular pulse. In an embodiment, an
IR channel plethysmograph from a detector response to an IR
wavelength LED is utilized to calculate PI. A plethysmograph
variability index (PVI) is then calculated that is responsive to
variations in perfusion index, as described below.
[0009] In an embodiment, PVI calculations utilize only PI values
resulting from acceptable plethysmograph pulses. For example, a red
channel plethysmograph responsive to a red wavelength LED is used
to verify acceptable pulses in the IR channel. Physiological
plethysmograph identification is disclosed in U.S. Pat. No.
7,044,918 titled Plethysmograph Pulse Recognition Processor, which
is incorporated by reference herein. PVI values are calculated from
a sorted and trimmed buffer representing a sliding time window of
PI values. The sort orders the PI values from the minimum PI at one
end of the buffer to the maximum PI at the other end of the buffer.
A predetermined number of both maximum and minimum PIs are deleted
from each end of the buffer and PVI is calculated as:
PVI=[(PI.sub.MAX-PI.sub.MIN)/PI.sub.MAX].times.100 (2)
That is, PVI is the PI variation, expressed as a percentage of the
difference between the maximum and minimum PIs remaining in the
buffer. In an embodiment, a median PVI is calculated from PVIs
stored in a second buffer. PVI is described in U.S. Provisional
Patent App. No. 60/873,663 filed Dec. 9, 2006 titled Plethysmograph
Variability Index, incorporated by reference herein. A PVI enabled
physiological monitor advantageously provides a noninvasive
numerical measure of hypovolemic conditions so as to titrate
patient fluids.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is an illustration of a physiological monitoring
system;
[0011] FIG. 2 is an absorption versus time graph of a standard
pulse oximeter plethysmograph;
[0012] FIG. 3 is an absorption versus time graph of a
plethysmograph exhibiting a respiration-induced, baseline cyclical
variation;
[0013] FIG. 4 is a plethysmograph illustrating measurement of a
plethysmograph variability index (PVI);
[0014] FIG. 5 is a general block diagram of an intravenous fluid
titration system;
[0015] FIG. 6 is a general block diagram of a physiological
monitoring system configured for a fluid titration application;
and
[0016] FIGS. 7-8 are illustrations of intravenous fluid titration
system embodiments.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0017] FIG. 5 illustrates a fluid titration system 500 having a
sensor 510 attached to a person 2, a physiological monitor 520, a
fluid titration controller 530 and an intravenous (IV) infusion
device 540. Advantageously, the fluid titration system 500 utilizes
a perfusion variability parameter, such as PVI described above, to
regulate the administration of fluids to a person so as to control
or prevent low blood volume or a hypovolemia. A noninvasive,
optical sensor 510 allows a measure of tissue blood perfusion by
detecting the absorption of sensor transmitted light by pulsatile
blood flow within a tissue site, such as a finger, foot or ear to
name a few. A sensor signal 512 responsive to that absorption is
received and processed by the physiological monitor 520, which
derives a plethysmograph variability index (PVI) or other measure
of plethysmograph variability or, similarly, blood perfusion
variability. A fluid titration controller 530 is responsive to PVI
522 and in particular to relatively large values of PVI indicating
relatively large variations in perfusion index, a potential
indicator of hypovolemia. The fluid titration controller 530, in
turn, provides a control output 532 to an intravenous (IV) infusion
device 540 so as to regulate circulating fluids and alleviate a
hypovolemic condition in the person 2. The IV infusion device 540
administers a liquid solution, such as blood products or nutrient
fluids injected directly into a vein (usually in the arm) at a
prescribed rate over a period of time. In a closed-loop embodiment,
the fluid titration controller 530 is responsive to PVI 522 or
similar measure so as to start, control the rate of, or stop the
infusion of fluids into the person 2. In an open-loop embodiment,
the fluid titration controller 530 presents a display or other
indicator 534 to a care provider 3 who manually inputs an
adjustment or other setting 541 into the infusion device 540 so as
to start, control the rate of, or stop the infusion of fluids into
the person 2.
[0018] As shown in FIG. 5, the fluid titration controller 530 may
be implemented in the physiological monitor 520, implemented in the
IV infusion device 540, distributed between the physiological
monitor 520 and the IV infusion device 540, or implemented as a
standalone processing device. In an embodiment, the fluid titration
controller 530 is a firmware process executed within the
physiological monitor 520, as described with respect to FIG. 6,
below. Physically, the physiological monitor 520 and the IV
infusion device 540 may be separate units, as described with
respect to FIG. 7, below, or combined into a single unit, as
described with respect to FIG. 8, below.
[0019] FIG. 6 illustrates a physiological monitoring system 600
capable of generating one or more blood parameter measurements such
as oxygen saturation, perfusion index, carboxyhemoglobin and
methemoglobin, to name a few. The monitoring system 600 has a
sensor 510 and a physiological monitor 520. The sensor 510 attaches
to a tissue site 1 and includes a plurality of emitters 610 capable
of irradiating the tissue site 1 with various wavelengths of light,
such as the red and infrared (IR) wavelengths utilized in pulse
oximetry or multiple wavelengths different than or in addition to
pulse oximetry wavelengths such as for measuring abnormal
hemoglobin constituents. The sensor 510 also includes one or more
detectors 612 capable of detecting the emitted light after
attenuation by the tissue site 1.
[0020] As shown in FIG. 6, the physiological monitor 520
communicates with the sensor 510 to receive one or more intensity
signals 614 responsive to one or more physiological parameters,
then calculates and displays the parameter values. The
physiological monitor 520 has drivers 620 that convert digital
control signals into analog drive signals capable of driving the
emitters 610. A front-end 630 converts composite analog intensity
signal(s) 614 from the detector(s) 612 into digital data 632 input
to a digital signal processor (DSP) 640. The input digital data 632
is referred to herein as a plethysmograph waveform or a
"plethysmograph" for short. In an embodiment, the input digital
data 632 is a multiplexed data stream including a red channel
plethysmograph and an IR channel plethysmograph generated from
alternate activation of red and IR wavelength emitters 610. The DSP
640 may comprise a wide variety of data and/or signal processors
capable of executing processes in one or more of hardware, software
and firmware for determining physiological parameters from the
input data 632. In an embodiment, the DSP 640 generates PVI
measurements 642 responsive to an IR channel plethysmograph portion
of the digital data 632.
[0021] Also shown in FIG. 6, a fluid titration process, such as
firmware executing on the DSP, inputs the PVI measurements 642 and
generates control values 644 that are communicated directly or
indirectly to an IV infusion device 540 (FIG. 5) so as to start,
stop, continue or modify the infusion of fluids into a person 2
(FIG. 5). In an embodiment, the fluid titration process 670 is
closed-loop and control values 644 are communicated to an IV
infusion device 540 (FIG. 5) without human intervention. In an
embodiment, the fluid titration process 670 is open-loop and
control values 644 are communicated to a care provider 3 (FIG. 5)
via a display 662, audible indicator 664 or other human interface
device so that the care provider can manually adjust or provide
settings for the IV infusion device 540 (FIG. 5) so as to regulate
fluid infusion into the person 2 (FIG. 5).
[0022] Also shown in FIG. 6, the instrument manager 650 may
comprise one or more microcontrollers controlling system
management, such as monitoring the activity of the DSP 640 and
communicating with I/O devices 660. In an embodiment, I/O devices
660 include one or more of a display 662, an audible indicator 664,
a user input 666 and a device interface 688. A display 662 includes
for example a readout, colored light or graphic generated by one or
more of an LED, LCD, plasma screen or CRT, to name a few. An
audible indicator 664 includes, for example, one or more of a
speaker or other audio transducer. The user input device 666 may
include, for example, one or more of a keypad, touch screen,
pointing device, voice recognition device, or the like, or a
network, computer or similar device that provides an external input
capability.
[0023] Further shown in FIG. 6, the display 662, the audible
indicator 664 or both in combination are capable of conveying
information so that a caregiver 3 (FIG. 5) can manually adjust or
otherwise provide inputs for a medical instrument, such as an IV
infusion device 540 (FIG. 5), according to digital data 632 derived
from an optical sensor 510 and processed by the DSP 640, the
instrument manager 650 or both. For example, besides displaying
indicia representative of calculated physiological parameters such
as one or more of a pulse rate (PR), signal quality and values of
blood constituents in body tissue, the display 662 is capable of
guiding manual adjustment of an IV infusion device, such as by
indicating a +, -, "on" and "off" to prompt a manual increase,
decrease, stop or start of fluid flow.
[0024] In an embodiment, the instrument manager 650 provides a
control signal 659 responsive to control values 644 calculated by
the fluid titration firmware 670. The control signal 659
communicates with a device interface 668 so as to generate a
corresponding IV infusion device control 532. For example, the
instrument manager 360 converts PVI measurements 344 to a control
signal 644 and transmits the control signal via the control port
659 to a device interface 668.
[0025] In an embodiment, an input port 658 responds to a user input
device 666, such as a keypad, network, computer or similar device
that provides an external interface. Using this interface, a
caregiver 3 (FIG. 5) can initialize the instrument manager 650 with
patient information, infusion device type and fluid type to name a
few. During operation, the instrument manager converts the control
values 644 to an appropriate control signal 659 according to the
initialization information.
[0026] The fluid titration process 670 may be DSP firmware that
executes a closed-loop algorithm for controlling an IV infusion
device 540 based upon PVI or other measured plethysmograph or
perfusion variability parameter. In an embodiment, the fluid
titration process 670 triggers a control output 644 so as to
disable fluid flow from the IV infusion device 540 if PVI falls
below a predetermined threshold or otherwise reflects that
hypovolemia may no longer be indicated for a patient 2 (FIG. 5). In
an embodiment, the fluid titration process 670 triggers a control
output 644 so as to enable fluid flow from the IV infusion device
540 if PVI increases above a predetermined threshold or otherwise
reflects that hypovolemia may no longer be indicated for a patient
2 (FIG. 5). In an embodiment, the fluid titration process 670
modifies a control output 644 so as to adjust the rate of fluid
flow or total administered amount of fluid flow from the IV
infusion device 540 according to changes in PVI that reflect that
hypovolemia may be decreasing or increasing in severity.
[0027] FIG. 7 illustrates a fluid titration system embodiment 700
having an optical sensor 710 attached to a person 2; a
physiological monitor 720; a sensor cable 730 interconnecting the
sensor 710 and monitor 720; an IV infusion device 740; a control
cable 750 interconnecting the monitor 720 and infusion device 740;
and an IV tube 760 also attached to the person 2. The optical
sensor 710 provides a sensor signal via a sensor cable 730 to the
physiological monitor 720. The physiological monitor 720 generates
blood parameter measurements and processes those parameters to
generate monitor and control outputs, as described with respect to
FIGS. 5-6, above. In particular, the physiological monitor 720
generates control signals via a control cable 750 to the IV
infusion device 740, which provides fluids to the person 2 via the
IV tube 760.
[0028] FIG. 8 illustrates another fluid titration system embodiment
800 having an optical sensor 810 and an IV tube 840 attached to a
person 2 at one end and an integrated physiological monitor 820 at
another end. The integrated physiological monitor 820 incorporates
the functions of a physiological monitor 520 (FIG. 6) and an IV
infusion device within a single unit or within physically connected
units.
[0029] A fluid titration system has been disclosed in detail in
connection with various embodiments. These embodiments are
disclosed by way of examples only and are not to limit the scope of
the claims that follow. One of ordinary skill in art will
appreciate many variations and modifications.
* * * * *