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A History of InnovationFromNovametrix To Philips
A History of InnovationFromNovametrix To Philips
Technical Staff – Philips‐Respironics
1
Summary
- Transcutaneous Blood Gas Monitors --
Novametrix from its early days as a small devices which measure oxygen and carbon
medical device startup to a division of a large dioxide levels through the skin.
multi-national corporation has remained patient
focused and interested in making a difference in - Pulse Oximeters – devices which measure
patient outcome. Through all of the changes arterial blood oxygen saturation levels and
associated with two acquisitions Novametrix pulse rates.
retained its entrepreneurial spirit. Using both in-
person and phone interviews with current and - Capnographs – devices which measure the
ex-employees, and reference materials such as level of exhaled carbon dioxide.
patents, clinical and scientific literature, product
literature, regulatory filings, and annual reports, - Respiratory Mechanics Monitors – devices
we have attempted to chronicle the innovations which measure pressure, flow and volume in a
in technology, the products and stories behind patient's airway and lungs.
them over the last 30 years.
- Volumetric CO2 Monitors - devices which
utilize the integration of CO2 and airway flow to
Introduction provide significant new parameters such as
airway deadspace and CO2 elimination and
The following product lines will be the primary clinical decision support such as VentAssist.
focus of this paper while highlighting the
innovations, the products and relevant clinical - Reusable and disposable sensors and
literature. adapters, related accessories and replacement
parts
- Airway Pressure Monitors – devices that
measure proximal airway pressure
2
Novametrix – Brief Corporate History
“The formation of Novametrix was brought about instrumentation for fetal and adult intensive
as a result of the extreme need within the medical care" during the five year period ending
community for quality instrumentation that could December 31, 1979. Lou who left Corometrics
be manufactured and marketed in accordance in 1976 commented “Rather than getting ulcers,
with the requirements of the users of the
equipment. We have responded to this need by
we decided the marriage wouldn’t work and we
creating a flexible environment in which members got a divorce.”3 A local paper notes that Lou
of the medical community interchange their ideas
for improvements with those of our engineers and .. was explaining why he left a young, promising
consultants.” (1979 Annual Report) company (i.e. Corometrics) to start a new
business from rock bottom. Wearing an open sport
shirt, he said “We need an environment for free
The early days - It is with this problem solving thinkers.”3
spirit that Novametrix1 Medical Systems, Inc.
was incorporated as a development stage Tom and Lou were interested in starting another
enterprise on March 13, 1978, commencing company and over a short period of time
activities April 1978 and shipments to customers assembled a team4. They knew Dr. Luis Cabal5
during April 1979 (Annual Report 1979). It was who had expressed the need for a neonatal
founded primarily of ex-employees of another ventilator monitor and a suction adapter. Dr.
Wallingford medical device company, Cabal was engaged as a consultant and the
Corometrics.2 (Figure 2) primary medical advisor for the company and
quickly became the ‘ideas’ man for the
company. The C/D (Cabal/Dali) suction adapter
became the company’s first product. This was
rapidly followed by the Pneumogard Ventilatory
monitor. Given that Pneumogard’s market
opportunity was viewed as limited, development
on the transcutaneous CO2 blood-gas monitor
was initiated.
(a) (b)
Figure 3 – Novametrix founders - (a) Lou Pellegrino
(1980), (b) Tom Abbenante (1983) (Photos courtesy
of Dirck Spicer)
(a)
9
Medscience product lines sold including to its PFT line to
Sensormedics
10
a privately owned developer and marketer of neonatal
and pediatric products and services now a separate
business unit within Philips
11 (c)
Wallingfordhas been promoting itself as a town to do
business in because it (a) operated its own electric utility Figure 6 – View of (a) building, (b)
(resulting in electricity 15% below the rate charged by the manufacturing floor and (c) engineering lab at 1
two major competitors in the state) and (b) developing Barnes Industrial Park Road (circa mid 1980s)
industrial parks. The health-related businesses in the park in
1979 included Corometrics, Galileo Electro-Optics,
Seamless Hospital Products, Hewlett-Packard, American
Cancer Society, Connecticut Hospital Association and
12
Connecticut General Life Insurance Co. Greg Cox, Carmelo Dali, Rich Mentelos, Gene Della
Vecchia (personal communication Carmelo Dali)
5
With additional rapid growth and expansion (to returned, Novametrix moved to a new building
300+ employees) in the 1980’s they moved in off Research Parkway at 56 Carpenter Lane in
early 1988 to a larger two story facility, designed Wallingford in August 1996 (Figure 8). The
and built for Novametrix, less than a mile away official address was later changed to 5
at 3 Sterling Drive in Wallingford (Figure 7). Technology Drive which was the access street
at the rear of the building.
(a)
7
Product lines risk of contamination of the patient's airway
without “breaking” the circuit.
Figure 12 – Airway pressure monitoring Technology –Products
The company’s initial focus on the neonatal (peak, distending, mean, transpulmonary),
market led them to innovate with respect to timing (I/E positive pressure ratio), airway
improvement in monitoring during mechanical temperature and inspired oxygen concentration
ventilation. NICU’s of the 1970s often used (FIO2). Table 1 lists the respective sensors used
adult ventilators, such as the Puritan-Bennett for these measurements.
(PB) PR2, PB MA-1 and Bird Mark-8 adapted for
use on neonatal patients with built-in monitoring Table 1 – Model 1230A Sensors
that consisted of little more than basic pressure Parameter Sensor
monitoring. Clinicians often inserted needles Airway pressure Data Instrument 6 psi
into the breathing circuit in order to measure gauge Model AB
pressure. Novametrix in conjunction with Dr. Esophageal pressure or Bentley Model 800
Luis Cabal recognized the clinical need to better central venous pressure
leverage the information available in the shape Oxygen concentration Ventronics Model 5510
fuel cell
of the ventilation (e.g. flow/pressure) and oxygen
Airway temperature YSI thermistor
waveforms. Also the need for improvements in
monitoring and surveillance of mechanically
ventilated patients was highlighted by
Of these parameters airway temperature, mean
Rattenborgg and Mikula (1977) which illustrated
airway pressure and FIO2 are considered
the range of clinical issues that can be
particularly important when monitoring neonatal
diagnosed with airway pressure monitoring
patients. For example, Ciszek et al. (1981)
including disconnections, faulty valves, and
studied mechanically ventilated infants with
obstruction.
respiratory distress syndrome (RDS) to
determine if mean airway pressure (MAP) could
Existing devices for ventilation monitoring were
be an effective means of controlling adequate
considered inadequate. For example, the
oxygenation and ventilation while PEEP and
Bournes Ventilator Monitor, Model LS-160
duration of positive pressure was altered. They
calculated only Ventilator Rate, Inspiratory Time,
found little change in oxygenation when MAP
Expiratory Time and I/E Ratio. The Novametrix
17 was held constant as ventilator changes were
Pneumogard 1230A Ventilatory monitor ,
made supporting the work of Boros, et al., which
introduced in 1979, leveraged on recent
determined that MAP is an effective means of
technology developments in piezoresistive
monitoring the pressures transmitted to the
pressure sensors and microprocessors to
airway while maintaining optimal oxygenation.
provided a flexible monitoring platform that
To specifically address the need for ventilation
included all of the LS-160 parameters as well as 18
monitoring, the Model 1200 monitor with a
a host of other parameters (see Table 2, Figure
single pressure transducer for airway pressure
13) whose value would be soon recognized.
measurement was introduced within a couple of
Pneumogard Model 1230A monitor, the first
years. Glenski et al. (1984) describes a study in
microprocessor based product (8085 based)
which mean airway pressure calculated using 4
from Novametrix, was a multi-purpose
different equations all using PIP, PEEP, TI and
ventilation and oxygenation monitor and
Ttotal was compared to mean airway pressure as
included measurements for various pressures
17 18
(510(k) #K781714 11/27/1978) (510(k) #K802955 12/19/1980)
9
measured by the Pneumogard Model 1200 useful in the early detection of pulmonary air
ventilatory monitor. The authors found that leaks in neonates with respiratory disorders.
calculated Paw using any of the four methods
described was inaccurate and impractical for The introduction of the Pneumogard family of
clinical use as variations in ventilator flow, monitors helped shape the future of ventilation
respiratory rate, patient compliance, and as the capabilities of the Pneumogard monitor
individual characteristics such as disease state were over the next several years adopted by
altered the calculated values. The Paw is an most ventilator manufacturers. This cycle of
important consideration in the ventilation of the introduction of pioneering and innovative
neonate. However, since calculated Paw is of technology followed by its introduction into the
limited value and in the clinical setting, the Paw ventilator as a standard feature has been
as measured by the Pneumogard monitor repeated several times in the history of
should be used. Banner et al (1981) noting Novametrix.
the clinical importance of mean airway pressure
as a “major determinant of both respiratory and
cardiovascular function” welcomed the
introduction of the Pneumogard 1230A monitor
which replaced the manual methods of
planimetry for estimating mean airway pressure
19
with automated and continuous methods
during all variations of positive airway pressure
therapy.
19 Using 100 Hz sampling rate mean airway pressure is
calculated using the arithmetic average of the samples in a
window ranging from 5 to 60 seconds
10
Table 2– Pneumogard Parameters and Ranges
11
Figure 13 – Pneumogard calculations (from Pneumogard ventilatory monitor, a technical guide) (a- ventilator
rate , b-peak airway pressure ,c- distending pressure, d-mean airway pressure , e-duration of positive pressure (DPP), f-I/E
g-transpulmonary pressure (TPP) , h-CPAP mode in which rate, DPP, I/E ratio and peak pressure are not calculated.
12
Transcutaneous
Figure 14 – Transcutaneous Technology -Products and innovations (1979 to 2009) (model numbers in blue are
summarized in table 3 from ECRI report) (Model 816A include FIO2 sensor; **Model 910 includes heart rate,
respiratory rate and invasive pressure).
Transcutaneous (through the skin) blood gas pressure, but where the CO2 sensor is "non-
monitors provide continuous and non-invasive consuming" there is no offsetting correction and
measurements of oxygen and CO2 levels in the the PCO2 is overstated. Severinghaus introduced
skin tissue of patients. The transcutaneous values a metabolic correction factor to bring the values
are not equal to the arterial values; rather, they closer to ABG levels. Based upon the magnitude
are a measurement of the skin tissue gas values. of the diffusion of the blood gas molecules, the
Even though the skin tissue gas values are monitor converts the sensor readings into a value
different parameters than arterial blood gas corresponding to the oxygen or CO2 at the
values, they can reliably follow the trend of arterial patient's skin surface and displays the information
blood gas values when patients are on the monitor. Premature and other critically ill
hemodynamically stable. Because they are newborn infants were and remain to this day the
different parameters, they have different "normal" primary patient group who benefit from the use of
values. transcutaneous monitoring. In view of their limited
blood supply, frequent invasive blood sampling
Transcutaneous monitors use single or has been recognized as traumatic and
combination parameter sensors attached to the unsatisfactory for these patients. Novametrix was
patient's skin surface to measure the amount of an early innovator in transcutaneous monitoring
oxygen and CO2 diffusing through the skin. being the first to develop heated tcPCO2 and dual
Vasodilation by heating the skin improves gas sensors. The very first CO2 sensors marketed by
diffusion but heating also raises the PO2 by Novametrix were not heated and although the
shifting the HbO2 dissociation curve. Fortunately measurements were much closer to arterial levels,
for O2 measurement, this increase is equally offset the slow response time hampered market
by the gradient induced by the consuming acceptance.
electrode. However, for CO2 the heating
increases local metabolism, raising the CO2
13
Transcutaneous devices of the late 1970s were 1979 (US patent# 4,290,431) with the first having
cumbersome to use and often required laboratory been filed the day before.
skills to use. For example, replacing the
membrane and zeroing the monitors was a labor
intensive and cumbersome process. For
example, devices from Radiometer (the major
player in transcutaneous measurement at the
time) required manual replacement of the
membrane which consisted of taking loose die cut
O2 and CO2 membranes from a vial using a
tweezer and stretching the membranes over the
face of the sensor held by an O-ring. Novametrix
with a sharp focus on ease of use introduced a Figure 15 – Model 818A O2/CO2 Transcutaneous
series of sensor innovations including the monitor with PtcCO2 heater mounted on left side of
Novadisk fixation apparatus (US Patent # monitor. Both sensors temperature were user
4280505). Novametrix addressed the ease of use selectable from 40C to 45C with the lower temps
in a number of areas: all the items to change the allowing more time between site changes.
membrane were included in a "prep kit"
(membrane, electrolyte and cleaning pad); first After the 818/818A monitors, both the monitor and
with a single use zero solution in a crushable sensor evolved. At the urging of clinicians such
glass ampule; and auto calibration with disposable as Dr. Kevin Tremper25, the company developed
gas cylinders. small portable battery powered oxygen only
transcutaneous monitors for use in clinical
Novametrix first introduced a combined O2 and environments such as the emergency room. The
CO2 transcutaneous device in 1980. The Model first of these portable monitors, the model 809,
81820 monitor21, of analog design (Figure 15 and was a big success and was responsible for much
19) originally provided only a heated O2 sensor. A of the company’s early growth. Several smaller
separate unheated CO2 sensor, as well as a single gas monitors, known as tcomette’s were
heated CO2 sensor, followed in short order as the introduced. Several oxygen only (model 816/
Model 818A but required the filing of the first and 816A, model 809A, 811, 910 and model 807) and
only Premarket Approval (PMA)22 in Novametrix’s carbon dioxide only (model 810) transcutaneous
history because no predicate existed for the tcCO2 monitors were introduced as well as battery
sensor. The tcO2 sensor would have also required operated versions of these monitors (model 809,
a PMA filing, as noted by Bradbury (1983) if a model 811) intended for transport applications.
single unit of a tcO2 monitor was not sold about The portable tcO2mettes 809A and 810 with the
three weeks before the enactment of the 1976 model 312 NovaGraph recorder were marketed as
Medical Device Amendment which established three independent building blocks which broke
three regulatory classes for medical devices. This apart the all-in-one instrument to provide flexibility
fortuitous timing exempted tcO2 sensors from the to the user. The model 809A was powered 8-10
more stringent filing requirements for a PMA. hours on its own batteries or via 12 volt
ambulance power or 115 volt wall power.
The O2 and CO2 sensors were originally designed
and manufactured by a 3rd party, Normand The model 850B, developed in Wales by the UK
Hebert23, with Rich Mentelos serving as the division of Novametrix, replaced the models 809
project engineer for the instrument. Working with and 810. It was the first portable monitor from
them was Richard S. Burwen of Analog Devices Novametrix to include both oxygen and carbon
fame.24 This collaboration resulted in the second dioxide.
of Novametrix’s patents which was filed June 21,
20
Named 818 by the project engineer Rich Mentelos after the
date which he began working on the design, 8/1/78.
21
(510(k) #K791152 08/03/1979)
22
PMA (#P810022) as a transcutaneous CO2 monitor
(heated) Original decision date 11/19/1981
23
At the time was the President of Microelectrodes, Inc. and
previously a research scientist at Corning Glass Research
Center.
24
In 1965, Ray Stata founded Analog Devices, Inc. with his
25
former MIT roommate, Matthew Lorber '56 E.E. and Richard Since 1990 Chairman of the Dept. of Anesthesiology, Univ.
Burwen (a Harvard alumnus). of Michigan Medical School
14
Figure 16 – Transcutaneous family of monitors (circa
1984)
26
(510(k) K840993 4/24/1984)
15
(a)
(b)
Figure 19 – Model 818 – (a) block diagram and (b) photograph (circa 1980)
16
Sensors - The sensor technology evolved from membranes were utilized on the PtcO2 electrode
separate heated sensors for O2 and CO2 to a sensor, there was no noticeable interference of
combination O2/CO2 sensor (CO2MMO2N the PtcO2 values with any anesthetic gases in
sensor) which allowed both PtcO2 and PtcCO2 clinically used concentrations, including
levels to be monitored from a single sensor site. halothane, ethrane, forane and ether.
The separate heated sensors originally
introduced (Series A) were larger than needed The Novadisk (Figure 21) ring provided the gas
and with advancements in technology were sensor with a removable fixation ring to which
reduced in size (Series C). (Figure 20) The the membrane can be attached prior to
original sensor design employed a single application of the fixation ring to the sensor. The
thermistor design but soon evolved into a dual fixation ring has mounted within it a membrane
thermistor design for improved reliability, safety for maintaining the solution in contact with the
and redundancy. cathode and anode thereby permitting the gas to
be measured to permeate into the ion solution. A
cover ring on the fixation ring helps compress
the periphery of the membrane to tension it and
provides an engaging surface which has an
adhesive coating for adherence to the skin. A
cap member that can be removed was attached
to the fixation ring for protecting the membrane
(a) (b) prior to use, and resiliently urging the membrane
toward the electrodes to bleed any entrapped air
from the system and displace excess electrolyte
between the membrane and the electrodes, and
to cause the membrane to conform to the profile
of the electrode surfaces thereby further
enhancing gas measurements.
(c)
Figure 20 – Separate Sensors – (a) Oxygen and (b)
Carbon Dioxide and (c) calibrator.
Figure 21 – Exploded
The O2 sensor comprises two basic parts (1) A view of Removable
Clark-type polargraphic electrode consisting of: Fixation Ring Apparatus
low oxygen consuming platinum cathode, silver (Adapted from US
Patent #4280505)
anode, electrolyte and oxygen-permeable
membrane (2) a heating section and precision
thermistor for measuring and controlling of O2
sensor temperature. The carbon dioxide sensor
utilizes a pH electrode based on the Stow-
Severinghaus principle. The CO2 sensor is
comprised of two parts (1) A CO2 electrode
consisting of a pH electrode, reference
electrode, electrolyte and carbon dioxide-
permeable membrane and (2) a heat section
and a precision thermistor for measuring and
controlling electrode temperature.
18
Clinical applications – The transcutaneous
sensors were cleared and marketed for use with
both neonates and adults in a number of
environments of use. With figures from the
1980 annual report, several applications using
Novametrix monitors are highlighted.
Figure 25 – Novametrix
transcutaneous sensor on
a “model” baby
Other
20
Table 3 – Comparison of Selected Novametrix Transcutaneous Monitors (adapted from ECRI
report, 1988)
21
Table 4 – Comparison of Model 840 with competitive devices (circa 1987-89)
22
Pulse Oximetry
The story of pulse oximetry and Novametrix at UCL. Given the apparent rapid growth of
(Figure 29) begins with the acquisition of pulse oximetry in the market it was decided to
Physiological Instrumentation Ltd., (PI) Whitland, act on the opportunity in early 1985. In less than
Wales, an R&D house. Physiological one year’s time, a prototype was readied by PI
Instrumentation (PI) founded by David Delpy for showing at the 1985 American Society of
and Dawood Parker (associated with University Anethesiologists meeting. This became the
College, London (UCL)) had been developing model 50028 (Figure 30), the 3rd entrant after the
transcutaneous products for various companies Biox and Nellcor N-100 pulse oximeters. It was
including Critikon and Johnson and Johnson. based on an 8 bit microprocessor (National
With Dr. Dawood Parker’s reputation for Semiconductor NSC800) and used a novel
expertise in electrochemical sensors and algorithm29 for calculation of saturation. With it a
Novametrix seeking to expand its offerings in line of sensors including a finger senor and a
transcutaneous technology, they acquired PI in family of wrap sensors was introduced. The
1983. Model 50530 soon followed with an improved
display (Vacuum Fluorescent) and the Model
Pulse oximetry, an alternate method of 515 (Figure 31) for cost reduction. The front end
assessing oxygenation than transcutaneous electronics from the Model 505 was combined
27
PO2, first commercialized by Biox in 1981 was with CO2, acquired from another acquisition
provided a significant boost by the introduction (Cascadia Technology Corp.), to produce the 1st
by Nellcor of the N-100 pulse oximeter in 1983. combined CO2/SpO2 monitor, the model 700031.
In 1984, Novametrix decided to initiate
preliminary work on pulse oximetry technology
28
29
K853124, 11/6/1985
27 Taylor, AC. US4759369: Pulse oximeter, 7-26-1988
Biox Technology founded in 1979 introduced the first
30
pulse oximeter for commercial distribution in 1980 was K873078 09/23/1987
31
purchased by the BOC Group in 1984. K874036 11/06/1987
23
In 1989, an impending loss and possible
injunction in a patent infringement lawsuit (later
reversed on appeal32) at the District Court level
necessitated the need to innovate in a hurry.
With advance notice of the release of a 20 bit
A/D from Crystal Semiconductor Corporation33
the engineers at Novametrix realized that they
could obtain sufficient dynamic range without the
need for additional circuitry for gain and sensor
brightness adjustments commonly used at the
time. Additionally, given that “motion” would
often cause designs with automatic gain
adjustment to shift the signal off-scale resulting
in clipping, the use of a sufficiently wide dynamic
range (e.g. 20 bit) would avoid clipping. Also,
through the use of a wide dynamic range input
Figure 30 – Model 500 pulse oximeter with early employing two 20 bit A/D convertors, the need
finger sensor for constant scaling of the measured signal due
to the inherent instability of the DC components
of the red and infrared signals was avoided.
This paradigm shift in pulse oximetry termed
34
‘digital technology’, patented by Novametrix,
appeared first in the model 515A with advanced
software (known as the VENUS technology). It
was soon followed in the other devices utilizing
pulse oximetry. Also defeatured versions of the
515A appeared several years later as the Model
(a) 515B, and 515C.
25
They enrolled patients when the N-200 pulse
oximeter was unable to obtain to obtain a
reading or when the pulse rate and/or pleth
waveform did not correlate with other monitored
parameters (ECG). They found that the MARS
algorithm performed the best of the oximeters
under test, achieving excellent results for
accuracy of readings relative to the co-oximeter
(-0.07+-1.67), percentage of time the monitor
failed to obtain a reading (0%) and percentage
of time the pulse oximeter heart rate correlated
with the ECG (93.3%).
(b)
Figure 37 – Power spectrum of two IR signals
s (a) with
h
primary freequency peak at
a 70 bpm and a secondary
frequency peak at 128 bppm and (b) with
h several
interfering frequency com
mponents.
(a)
27
This foccus on reu usable senssors allowed d
Novametrrix to offer Hospitals a Sensorr
Managem ment Program m which was designed to o
reduce ho ospital operatting costs. ForF a fraction n
of existingg operating costs
c and wiith no capital Ne
eonatal toe an
nd foot applica
ation of Y sen
nsor
expenditu ure by the customer,
c hoospitals could d with wrap
upgrade to Novametrix pulse oxximeters with h
reusable sensors under the Novametrixx
Capitated Oximetry Conversion
C Program. Thiss
program capitated (or limited) contractt
expenditu ures while prroviding the hospital with h
new pulsse oximetry monitors, sensors,s andd
accessories, each of which
w is warra
anted over the e Finger and hand app
plication
e contract. The
life of the T program provided an n
unconditioonal guaranttee for the sensors and d
monitors over
o the life of
o the contracct, for a fixed,
predictablle cost which was often just one-half off
the hospital's priorr spending levels forr
disposable sensors alo one.
28
Debate – Transcutaneous vs. Pulse Oximetry
In the early 1980s as the transcutaneous market resulting in tissue hypoxia. In this case,
began to develop and expand into the adult neither PaO2 or O2 Saturation may show
population, pulse oximetry monitors began a significant change, but tcPO2 will
appearing on the market. This fueled a clinical, immediately indicate any change in the
technical and market debate about which level of skin oxygenation, alerting the
technology is better for measurement of clinician to possible impairment of
oxygenation (see Table 5). For various reasons oxygenation of vital organ tissues.
particularly including ease of use, pulse oximetry • A normal tcPO2 provides assurance that
won that debate and is now considered a the skin is properly oxygenated, which,
‘standard of care’ while transcutaneous remains in all likelihood, means that the vital
important in the NICU, its use in adult patients organs are properly oxygenated. The
remains limited. advantage, then, of transcutaneous
monitoring is that it gives the clinician
Transcutaneous monitoring's advantages the ability to diagnose the drift toward
relative to arterial blood sampling are relatively pathophysiologlcal states sooner, and
straightforward. begin corrective action sooner.
• noninvasive and no associated morbidity. Drs. Tremper and Shoemaker wrote a
• continuous value, unlike direct sampling, Letter-to-the-Editor responding to a paper
which is a periodically obtained value and published in the The New England Journal
might not be checked until something is of Medicine in which they stressed that
already seriously wrong with the patient. transcutaneous oxygen tracks oxygen
• earlier warning of a sudden drop in arterial delivery during conditions of low cardiac
oxygen tension than do blood pressure output which makes it a very valuable
and heart rate monitors. monitoring tool. They also emphasized that
transcutaneous oxygen is a new variable
With respect to oximetry, several arguments and has its own range of normal and
were made including (fromBioChem) - abnormal values. In conclusion, Tremper, et
al. stressed that transcutaneous oxygen
• tcPO2 is linearly related to PaO2. The monitoring provides early warning of
relatively flat upper portion of the Hgb circulatory failure and that they find it
dissocation curve poses a major extremely useful in daily practice.
drawback in the capability of oximetry to
provide an early warning of hypoxemia.
• The affinity of hemoglobin for oxygen is
increased due to the rise in pH and less
oxygen is liberated to the tissues
29
Capnography-Sensors
Novametrix first entered the capnography 1990) This approach was used in the CO2SMO
market in 1985 with a sidestream CO2 monitor, and CO2SMO Plus! monitors and TidalWave
the microprocessor based Model 1250 Model 710/715 handheld monitors (Figure 44b).
capnograph38 which used an infrared CO2 bench
from Andros Inc.39 (model 412, Andros, Inc.,
Berkeley, CA). The Model 1250 (Figure 43)
employed a dual function 2 digit LED segment
display. It allowed toggling between ETCO2 and
minCO2 as well as respiratory rate and % mean
N2O. Several LEDs on the front panel provided
functionality such a SYSTEM READY, and
sample line occlusion. There were alert LEDS
above each numerical display for ETCO2 and
respiratory rate. Upper and lower limits for
ETCO2 and respiratory rate were set using
thumbwheels with ETCO2 set between 0 and 99
mmHg and RR between 0 and 999, although
150 b/min was the maximum RR specified for
measurement. An oxygen compensation button
was provided to indicate if level was less than or
greater than 60% O2. Flow rate was selectable
as either 50 or 150 ml/min. Analog output (via
BNC connectors) was available for direct Figure 43 – CAPNOGARD Model 1250 monitor
interfacing to the NovaTracer Model 350
(K844010 02/21/1985) and CAPNOGARD CO2 meter
recorder, the CAPNOGARD CO2 Meter Model
1255 or an input channel of a monitor. The
sample cell (see Figure 43) was located in Mainstream - The story of the development of
sample chamber on the front panel where it the Novametrix mainstream Capnostat CO2
could be easily removed and inspected for sensor has its roots in another company,
contamination. Cascadia Technology Corporation. Cascadia
was founded from the aftermath of a previous
In an effort to provide an innovative single company Trimed, which was organized in 1981
sensor solution for both mainstream and and developed a qualitative CO2 detector
sidestream monitoring, later designs adapted followed by a quantitative sidestream analyzer
Novametrix’s mainstream technology with with a rotating chopper wheel and associated
special adapter (Figure 44a) to provide cost disposables. This included the Model 126
effectively both mainstream and sidestream sample line41 with extended life using Nafion for
40
capabilities in the same monitor. (Mace et al., the first time in a braided shield so it could be
38
39
K844010 02/21/1985, used Motorola 6809 microprocessor
Now owned by Lumasense Technologies. 41
One of the first to build oral and nasal sampling cannulas with
40
Mace LE, et al. US4958075: Gas analyzer, 9/18/1990. Nafion
30
easily manipulated.42 After three years of could be pulsed in a bi- or unipolar fashion at
funding their new start up, Trimed’s parent relatively low power levels with sufficient IR
company, “pulled” the plug and sold its assets. output. As did other manufacturers of
mainstream devices, Cascadia’s founders spent
the early days of Cascadia (and later as
employees of Novametrix) refining the IR source
(Figure 45) to make it easier to manufacture,
more shock insensitive and with higher optical
output,
(a)
42
Tri-Med Model 126 Sample Line w/extended life NAFION®
510(k) # K850746 – later assembled by PermaPure.
31
In 1987 Cascadia licensed their technology to
Novametrix Medical Systems and in 1989 they
were purchased by Novametrix. A number of the
staff remained on in Redmond, WA. as a sensor
development group for Novametrix until the
facility was eventually closed in 2001. Concerns
with accumulations on the window affecting the
measurement led to the coaxial beam innovation
which first appeared in the Capnostat II sensor
(Figure 50). The coaxial beam approach
assured that both the measurement (data) and
reference (no CO2) channels would ‘see’ the
Figure 47 – Capnostat “1” design
same signal to be able to effectively correct for
interference (Figure 51). Given that these
devices were used on airway, the devices had to
be particularly robust. This led to internal design
improvements which allowed the device to
survive multiple 6 foot drops onto a hard
surface. This design also continued to provide a
gasless optically based means to check the zero
and reference settings of the device (Figure 49).
32
includes the Capnostat sensor in combination
with supplemental oxygen delivery. Robustness
in this environment required innovations in both
optical and electrical assembly. Internally
43
developed drop testing procedures in excess
of published medical device standard
requirements has demonstrated this robustness.
(a)
(a)
(b)
Figure 51 – Capnostat III mainstream sensor - (a)
Exploded view of the case with the integrated
source/detector assemblies; (b) cross-section
showing source 134, mirror 140, beam splitter 286,
detectors 270/272 and filters 302/304. (US patent
#5,793,044)
(b)
(b)
34
(a)
(b)
Figure 55– Capnostat advertisements - (a) Early advertisement for Capnostat I sensor (Note- the “guts” of a Model
1250 is shown on the left); (b) Capnostat III advertisement
35
Sidestream - Novametrix recognized that novel approach coupled with a new sidestream
although the mainstream sensor offered a bench, LoFlo, was quickly adopted by several
number of advantages over a sidestream major monitoring companies. Whether gas
solution, they needed to provide a sidestream monitoring is performed by a diverting
solution as well. The novel approach taken was (sidestream) or non-diverting (mainstream) gas
to use the mainstream head with a sidestream monitor is often determined by what is available
airway adapter which was connected via a to the clinician and not what is optimal for the
sampling tube of several feet to a pump that was application. The LoFlo and Capnostat sensors
integrated into the monitor. Figure 56a show a provide the clinician with the ability to choose
Capnostat I sensor engaging an airway adapter between a compact mainstream and/or
intended for use in a breathing circuit whereas sidestream solution.
Figure 56b shows the same sensor engaging a
sidestream airway adapter. In order to address
the needs of different markets, both neonatal
and pediatric/adult reusable and disposable
mainstream airway adapters were developed in
addition to the sidestream airway adapter.
(Figure 57)
(a)
(b)
Figure 56 - Capnostat I sensor (a) with mainstream
(a)
airway adapter and (b) with sidestream airway
adapter.
Figure 59 - Exploded view of the sample cell (a)
receptacle assembly from the detector assembly side
37
Respironics LoFlo “C5” sidestream monitoring
platform adapted the technology in the
mainstream Capnostat 5 sensor platform to a
sidestream platform. This platform contains in a
single package all of the front-end electronics,
signal processing and optical components
needed for a capnometer. By integrating all of
the signal processing and control functions into
the sidestream module and assembling it in a
compact way using a novel manifold structure,
a simple to use, compact sidestream solution
has been achieved (about the size of a
computer mouse (Figure 61)) . This enables a
complete sidestream module to be provided that
(a) requires only a power source and serial
connection.
(b)
(a)
(b)
(c)
Figure 61- LoFlo module44 (a) engine (b) with sample
cell . in a package only measuring only 4.5 cm (W) by
7.5 cm (L) by < 3 cm (H) and (c) with pole attachment
(c)
LoFlo - The LoFlo “C3” sidestream monitoring
platform interfaced to host monitors via existing Figure 62 - LoFlo accessories – (a) airway adapters
mainstream connector and emulated the signals (adult and neonatal) and representative nasal cannula
required to interface to those connectors. The with sampling tube and sample cell, (b) current
neonatal airway adapter, and (c) neonatal nasal
cannula with sampling tube and sample cell.
44
K053174 01/12/2006
38
Algorithms - Respiratory rate measurement in including the area under portions of the
both the Capnostat 5 and LoFlo families of CO2 waveform to exclude breaths which are unlikely
sensors employ a robust breath detection to be “real” breaths. These two algorithms have
algorithm with an adaptive threshold criteria been developed over a twenty year period and
followed by a selectable screening/validation are in use in hundreds of thousands of systems
algorithm. This screening algorithm termed the worldwide.
ReNÉ™ algorithm uses waveform morphology
Table 6. Comparison of Mainstream Capnostat and Sidestream LoFlo CO2 Measurement Solutions**
Required components to sample gas Airway adapter and sensor Airway adapter, sample tube, water trap
or filter
Use on extubated patients Yes with a facemask or mouthpiece Yes with a nasal adapter or O2 prongs
Connecting tube or cable Thin medium weight flexible cable – no Small bore (1 mm ID) sample tube
sample tube
Airway connector disposable? Both reusable and disposable Only disposable
Cost of replacing airway connector Low Inexpensive but dependent on how wet
circuit is
Can be used in collaboration with O2 Yes with facemask, captures oral and Yes with nasal prongs- concerns about
administration nasal gases sample dilution
Zeroing If requested – manual < 20seconds If requested? (infrequently)
Response
Delay between sampling and waveform negligible < 3 seconds
Sensor 10-90% rise time < 60 msecs Approx 200 msecs
Changes due to water vapor pressure Not affected – measures actual partial May be affected by condensation and
pressure drying of sample
Moisture handing Window heater or treatment to prevent or Water trap or blocking filter (may use
reduce droplet condensation on window Nafion tubing as well)
Potential of cross-contamination between None with disposable adapters Varies-none if sample set disposed and
patients no return of gas to circuit; otherwises
proper protective means required
Gas scavenging Not required Scavening/return to circuit issues and
anesthestic “pollution” risk must be
assessed
Airway pressure compensation Not required Pressure fluctuations due to sampling
system may be compensated
**Weight of airway adapter similar and location at end of ETT,, calibration not routinely required
39
Capnography-Monitors
Figure 63 – Capnograph Timeline (excludes volumetric capnography devices)
(a)
(b)
Figure 65- Model 1260- (a) front panel, (b) display Figure 66 – Entering Teach Mode
40
This mode provided the ability to freeze a world. The Tidalwave model 610 capnograph
waveform and load a stored library waveform (Figure 68) has been shown to perform well
with explanatory text in order to compare. This during emergency intubations outside the OR as
‘teach’ mode (Figure 66) helped the clinician well in the OR both in adult and neonatal
more quickly learn the characteristic CO2 shapes patients (Nochimson et al., 1997). It also has
and uses. Teach mode derived from digitized been used to evaluate respiratory depression in
versions of capnographic tracings based on laboring women who have received intrathecal
ideas from Smalhout text (Figure 71a/b). sufentanil (Atkinson et al., 1998).
(a)
41
(a)
(b)
Figure 70 – Photo of astronaut testing a
CO2SMO CO2/SpO2 monitor with Capnostat CO2
sensor and finger pulse oximeter sensor , and
mission patches for STS‐69 and STS‐72 shown
(Photo courtesy of NASA)
42
(a)
(b)
Figure 71 – Use of “Teach Mode.” - (a) “Frozen” Capnograms with Normal; (b) “Frozen” Capnograms with Partial
Obstruction
43
Flow-Sensors and Modules
Sensors - The measurement of proximal flow in use of a fixed orifice design46 in the mid-1990s
the critical care environment can often be challenged available state-of-the-art low
challenging particularly given the high humidity pressure sensors because to achieve a 200:1
and secretions present and that the length of range in flow required greater than a 10,000:1
mechanical ventilation can last from days to range in differential pressure. Improvements in
weeks. Due to their robustness, differential pressure sensor performance coupled with high
pressure based flow sensors are often used in dynamic range (20 bit) analog to digital
clinical environments. Respironics flow sensors, convertors made this approach both technically
particularly suited to these harsh environments, and commercially viable. Airway pressure is
are fixed orifice, target type flowmeters, and as measured from the proximal pressure sensing
such the pressure drop is proportional to the tube with a gauge pressure transducer.
square of the flow. The Respironics family of Barometric pressure is measured with an
fixed orifice flow and CO2/flow sensors grew absolute pressure transducer with built-in
from an alliance with a research group in the temperature compensation.
Department of Anesthesiology at the University
of Utah (Korr)45. In an effort to simplify the calculation of
volumetric capnography variables, reduce
Due to the need to avoid individual sensor deadspace and improve ease of use, a family of
calibration and robustness in the harsh combined CO2/flow airway adapters (Kofoed et
environment of a breathing circuit, a fixed orifice al, 1998) was developed. This included sensors
design was chosen. Early prototypes consisted optimized for neonatal, pediatric and adult
of adding pressure sensing ports on both the patients (Table 7). The combination adult
proximal and distal sides of the optical window in sensor design included the sample cell and fixed
a mainstream CO2 cuvette. (Orr, 1993) An adult orifice portion side-by-side with the sample cell
flow only sensor was designed first (Kofoed, proximal to the patient (Figure 73) whereas the
1996). It featured a target geometry composed combination neonatal sensor combined the
of a center strut and side-mounted flow sample cell and fixed orifice portion by use of a
restrictions (having a notch in the strut) that are split orifice design. These designs allow for
designed to minimize localized streamline relative immunity to unpredictable flow velocity
effects about the pressure sensor aperture. The profiles, without the need to add excessive
length to the flow sensor adapter (i.e. minimizing
dead space). (Figure 73).
45
Novametrix acquired an exclusive license of the patents
and related technology from Korr Medical Technologies Inc.,
the stockholders of which are Joseph Orr, Dwayne
Westenskow and Scott Kofoed, pursuant to a License,
Technical Assistance, Cooperation and Noncompetition
46
Agreement (the "License Agreement") dated as of December With fixed orifice designs flow is proportional to the
10, 1993 and amended as of June 21, 1994. (10-Q filing) square root of the pressure difference.
44
With sevveral valves required fo or the
zerooing and purg ging function ns in bedside e flow
monitoring system ms, the numb ber of connecctions
betwween differen nt components (e.g. va alves,
senssors) results in a greater potential
p in leaaks at
these connections thus affecting the reliabiility of
the measuremen
m t. Also this complexity re esults
in inccreased varia
ability in the pneumatic
p patthway
thereeby increassing the variability
v in the
(a) measurements particularly under oaded
lo
cond ditions (e.g. low com mpliance, higher
h
pressures).
(a) b)
(b
Figure 74 - Capnostat CO
O2 sensor “matting” with (a)
combined neonatal
n CO2/fflow sensor and
d (b) combined d
combined adult
a CO2/flow sensor.
45
Table 7 – Nominal Ranges and Values of Selection Criteria for Combined CO2/flow Sensors
(b)
(c)
Figure 75 – Original FloTrak OEM module (a) top
47
view and Flotrak Elite Module - Two views (b)
Figure 76 - Vent√ hand-held monitor, measuring 8"
high, 3" wide and 1-1/2" deep and battery operated.
47
(K080652 06/20/2008)
48
K964360 04/04/1997
46
Combining the measurements
The evolution of Novametrix’s cardiorespiratory the Fleisch type and variable orifice flow sensors
monitors and its continued innovations in as well as for verification purposes.
volumetric capnography and related
measurements goes back to the early 1990’s
with the introduction of the Ventrak monitors.
The Ventrak series of respiratory mechanics
monitors provided continuous and non-invasive
graphical monitoring of airway flow, airway
pressure and lung volume. They also had the
ability to perform waveform (graphical) analysis
and calculate a variety of physiologic
parameters relating to lung function which was
not previously available on a continuous, non-
invasive basis for infant through adult patients.
Model 1500 - The interest in this type of
monitoring can be traced back to the influential Figure 78- Ventrak model 1500 front and rear panels
Pneumogard series of monitors. Novametrix
expanded its product offerings in on-line
respiratory mechanics monitoring with the
acquisition from Med Science of its product
named Ventrak (for ventilation tracking) to
create the Respiratory Mechanics Monitor
(RMM).49 The Ventrak RMM Model 1500
system consisted of a ‘box’ with the front end
electronics (Figure 78) that was integrated with
an all-in-one personal computer. It was popular
with respiratory therapists for research. It
allowed for a number of different flow and
pressure sensors to be interfaced to it (see
Figure 79) and used a disposable variable orifice
flow sensor for adult monitoring and either a
Fleisch type or heated wire flow sensor for
neonates (Bear NVM monitor) (Figure 80). A
syringe was usually provided for calibration of Figure 79 – Ventrak model 1500 setup for the
mechanically ventilated adult
49
Med Science was exploring with clinicians at the
University of Texas Medical Branch at Galveston (UTMB)
applications using post-processing of signals of bedside
volumetric capnography using the Ventrak monitor and
Novametrix Model 1265 capnograph. This work interested
Novametrix and was eventually embodied in the Ventrak
1550/Model 1265 monitor.
47
variables such as VCO2 and dead space could
be computed. The flow connector which plugged
into the receptacle on the front panel of the
monitor consisted of 3 ports – two for the
differential pressure measurement and a third
for an optional auxiliary measurement which
could be used for carinal and esophageal
pressures. It also provided for a Bear NVM
connection as well. The monitor interfaced to an
all-in-one PC which provided for waveform and
data display. Figure 82a/b illustrates one such
display in which the patient and mechanical
breath data are displayed in separate columns
and the averaged data noted, and a flow-volume
and pressure-volume loop screen with an
esophageal pressure measurement available.
In addition to the “normal” respiratory mechanics
parameters, the addition of esophageal pressure
permitted the calculation and display of work of
Figure 80 – Ventrak Model 1500 (a) variable orifice breathing (mechanical, patient and imposed),
adult flow sensor (Carlsbad Varflex flow sensor) and P0.1 and pressure-time-product.
(b) neonatal low deadspace flow sensor (Hans
Rudolph flow sensor) (also compatible with NVM flow
sensor).
(a)
(a) (a)
(b)
(b)
Figure 85 – CO2SMO Plus! (a) monitor (Note:
connector for flow sensor on front and on rear panel
for Capnostat CO2 sensor) (b) screen displays
available.
50
NICO- Non-invasive partial rebreathing cardiac directly related to the PCBF (Figure 89) (Orr JA
output has been of interest to Novametrix since and Kuck K, 2003)
the publication by Capek and Roy of their work
in the late 1980s.(Capek and Roy, 1988) The
NICO monitor52 introduced to the market in 1998
(Figure 88a), was the first widely available
clinical device to non-invasively measure
pulmonary capillary blood flow (and as such
cardiac output) using the indirect Fick partial
rebreathing technique. With the use of a NICO
sensor (i.e. combined CO2/flow sensor with
valve and adjustable loop of tubing (Figure 91))
and the use of a rebreathing maneuver
controlled by an in-line valve (Figure 92), cardiac
output and pulmonary capillary blood flow (a)
(PCBF) can be estimated every 3 minutes. The
NICO monitor(s) (Figure 88) offer several
advances including "hands off" automatic
continuous operation, completely non-invasive
techniques and easy to use functionality.
Although cardiac output is considered by many
to be the best indicator of heart function, it has
not been routinely monitored in patients
undergoing general surgery because available
(b)
techniques were too invasive (risky), costly or
technically difficult. The NICO monitor remains
to this day the only commercially available
monitor than measures PCBF which unlike
cardiac output directly reflects the amount of
blood involved in gas exchange. As such PCBF
can serve as a useful clinical parameter suitable
for measurement and optimization.
Figure 90 – Adjustable rebreathing loop with Figure 92 - Valve Section – (a) Normal Mode, (b)
cardboard volume guide Rebreathe Mode
The NICO monitor provides a continuous display Clinical literature - In 68 patients Botero et al.
of cardiovascular monitoring variables (Figure (2004) validated the NICO monitor and
93) including PCBF, cardiac output, stroke thermodilution against a more direct standard,
volume, cardiac index and heart rate. In transit-time flowmetry of the ascending aorta
addition, NICO provides real time displays of using an ultrasonic flow probe (UFP) and found
other physiologic variables including CO2 clinically equivalent accuracy of these methods
elimination, end tidal CO2, respiration, oxygen relative to the invasive UFP standard. Since the
saturation, heart rate and respiratory mechanics NICO monitor’s introduction over 150 peer
parameters based on measurements of reviewed papers and abstracts have been
capnography, airway flow and pulse oximetry. published either validating the measurement or
These monitors are the only stand monitors applying it clinically in anesthesia, critical care
which monitor physiologic gas exchange and medicine (Figure 96) and emergency medicine.
reveal dead space, CO2 elimination and A recent study, Young and Low (2010)
effective tidal volumes at the alveolar level. summarized the clinical literature to date for the
device.
52
Clinical applications of this versatile device
include monitoring patients during surgery (in
the operating room), in the emergency room and
in the intensive care unit. It provides a needed
alternative to the conventional invasive
procedure for monitoring cardiac output,
(thermodilution), which requires insertion of a
catheter through the heart and into the
pulmonary artery (PA). Patient safety can be
enhanced by eliminating the documented
hazards of PA catheters which include
infection, embolism and heart or lung tissue
damage. By eliminating the costs, risks and
complications associated with the use of PA
catheters, the NICO monitor is dramatically
(a)
simpler and less costly to utilize. Further, since
the NICO monitor is non-invasive and easy to
operate, the use of this technology may be
expanded to other applications where it was
previously deemed too risky or costly.
(b)
Figure 93– Screens – (a) Cardiac output screen from
NICO monitor; (b)waveform screen from NM3 monitor
53
Figure 97- VentAssist Screen
(b)
(a)
60
At the time Professor of Obstetrics and Gynecology and
Vice President for Health Affairs of the University of
Southern California School of Medicine, also one of the
principal founders of the subspecialty of maternal fetal
medicine.( http://www.obgyn.uci.edu/QuilliganBio.html)
56
Herb Pittman, Rich Mentelos, Tony Pierry, Mike
Polson, Dave Rich, and Dirck Spicer.
Table 9 - Model1260/7000 capnograph research
sites (early 1990s)
Institution Clinician(s)
Vanderbilt University - Drs. John Marini, John
Knoxville, TN Truwit
Charity Hospital of New Dr. Kevin Ward
Orleans
Hospital for Sick Children- Dr. Jerrold Lerman Trademarks
Toronto
University of Maryland - Drs. R. Viscardi, Alice Capnostat, LoFlo, NICO, NICO2, NM3,
Division of Pediatrics, Ackerman Novametrix, CO2SMO Plus!, Analysis!,
Baltimore
Mass General -Boston Drs. Todres and Castillo Novacard, Ventrak, Ventcheck, Tidal Wave,
Institute of Anesthesiology, Prof. Bob Smalhout and FloTrak are trademarks belonging to
University Hospital, Utrecht, Koninklijke Philips Electronics N.V. Magstim is a
Netherlands trademark of the The Magstim Company Ltd.
University of Iowa Dr. Frank Scamman
LAC/USC Women's Hospital Dr. Luis Cabal
- Los Angeles CA
Dedication
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62
Appendix – Novametrix Product Clearances novametrix model 505 K873078 9/23/1987
pulse oximeter
novametrix model 200 K871338 8/4/1987
Product Name 510(k) Clearance magstim
Number date model 840 transcutan. K870805 5/27/1987
mercury vco2 K092217 8/21/2009 oxygen/carbon dioxe
philips nm3 monitor, model K091459 7/28/2009 novametrix pulse oximeter, K853124 11/6/1985
7900 model 500
mercury vco2 module with K080652 6/20/2008 novametrix 350 recorder- K850487 3/29/1985
capnostat 5 paper chart reco
loflo c5 co2 sensor K053174 1/12/2006 cpnogard capnometer 1250 K844010 2/21/1985
63
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