Title of Invention

DEVICE, METHOD AND SYSTEM FOR MONITORING PRESSURE IN BODY CAVITIES .

Abstract The present invention relates to a system and method for digital sampling, quantitative analysis and presentation of pressures in a body cavity. The invention also relates to a portable apparatus for monitoring, sampling and storing pressure and a software for analysis of pressures. The invention includes an algorithm for analysis and presentations of pressures and a software for performing the analysis. The computer software may be integrated in the portable apparatus and in a variety of systems. The software provides different quantitative presentations of pressure curves as a matrix of numbers of intracranial pressure elevations of different levels and durations and a matrix of numbers of single pulse pressure waves with preselected characteristics. The parameters may be standardised according to recording time and heart rate variablity. The data may be presented indifferent ways, both on-line and off-line after pressure monitoring.
Full Text METHOD FOR ANALYSING PRESSURE SIGNALS DERIVABLE FROM A BODY
CAVITY
BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates to a method for analysing pressure-signals derivable
from pressure measurements on or in a body of a human being or animal,
comprising the steps of sampling said signals at specific intervals, converting the
pressure signals into pressure-related digital data with a time reference, as defined
in the preamble of attached claims 1 and 34. The invention provides for
monitoring and of pressure within body cavities in human body or animal body,
e.g. intracranial pressure and blood pressure, and even in cavities such as e.g.
cerebrospinal fluid space. The invention provides for analysis of pressure signals
subsequent to sampling, recordal, storage and processing of pressure measurement
signals, and thereby quantitative analysis.
Related Art
The clinical use of intracranial pressure monitoring was first described by Janny in
1950 and Lundberg in 1960.
In the clinical setting, the question may be whether a continuous pressure recording
of several hours is normal, borderline or abnormal. Continuous intracranial
pressure curves usually are evaluated by calculation of mean intracranial pressure.
With regard to rises in pressure most authors identify so-called pressure waves:
Lundberg's A waves (50-10 mmHg lasting 5-20 minutes), B waves (up to 50
mmHg with a frequency 0.5-2/min), and C waves (up to 20 mmHg with a frequency
4-8/min). However, the description of such waves is quite subjective and based on
a morphological description of the waves. Actually the various authors differently
describe such waves.
The present invention deals with strategies to analyze single pulse pressure waves,
and make analysis of these waves available to the daily clinical practice. The
fluctuations of intracranial pressure arise from cardiac and respiratory effects. The
intracranial pressure cardiac waves or cerebrospinal fluid pulse waves result from
the contractions of the left cardiac ventricle. The intracranial pressure wave or the
cerebrospinal fluid pulse wave resemble the arterial blood pressure wave, that is
characterized by a systolic rise followed by a diastolic decline and a dicrotic notch.
In addition, changes in pressures associated with the respiratory cycle affect the
intracranial pressure wave. The morphology of the intracranial pulse pressure wave
depends on the arterial inflow, venous outflow, as well as the state of the
intracranial contents. The single pulse pressure waves of intracranial pressure
include three peaks that are consistently present, corresponding with the arterial
pulse waves. For a single pulse pressure wave the maximum peak is termed P1 or
top of the percussion wave. During the declining phase of the wave, there are two
peaks namely the second peak (P2), often termed the tidal wave, and the third peak
(P3), often termed the dicrotic wave. Between the tidal and dicrotic waves is the
dicrotic notch that corresponds to arterial dicrotic notch. In the present application,
the amplitude of the first peak (?PI) is defined as the pressure, difference between
the diastolic minimum pressure and the systolic maximum pressure, the latency of
the first peak (?TI) is defined as the time interval when pressures increases from
diastolic minimum to systolic maximum. The rise time (?PI/?TI)) is defined as
the coefficient obtained by dividing the amplitude with the latency. The
morphology of the single pulse pressure wave is intimately related to elastance and
compliance. Elastance is the change in pressure as a function of a change in
volume, and describes the effect of a change in volume on intracranial pressure.
Compliance is the inverse of elastance and represents the change in volume as a
function of a change in pressure. Therefore, compliance describes the effect of a
change in pressure on craniospinal volume. Elastance is most useful clinically as
elastance describes the effect of changes in intracranial volume on intracranial
pressure. The relationship between intracranial pressure and volume was described
in 1966 by Langfitt and showed an exponential curve, where the slope of any part
of the curve resembles the rise time of a single wave (that is ?P/?T or change in
pressure/change in volume). The curve is termed the pressure-volume curve or the
elastance curve. The horizontal part of the curve is the period of spatial
compensation whereas the vertical portion is the period of spatial decompensation.
When elastance increases also the amplitude of a single pulse pressure wave
increases due to an increase in the pressure response to a bolus of blood from the
heart. It has, however, not been possible to take the knowledge of single wave
parameters into daily clinical practice.
Another reason for the less widespread use of continuous intracranial pressure
monitoring in not critically ill patients is that there are still no generally accepted
methods for analyzing intracranial pressure. Though there are large amounts of
experimental data concerning single pulse pressure waves and their relationship to
the pressure volume curve, the clinical application of this knowledge has not been
straightforward. During continuous intracranial pressure monitoring in clinical
practice the single pulse pressure waves are not assessed and used in the decision
making. An indirect approach has been Fast Fourier Transformation or spectral
analysis to assess the frequency distribution of the various waves. Strategies to
examine the pressure volume relationship in a single patient have involved infusion
of fluid to the cerebrospinal fluid space or inflation of a balloon, but these
strategies are invasive, and neither involve assessment of single pulse pressure
waves. In the clinical context, methods to explore the pressure-volume
relationships or elastance by analysis of the pressure curve are lacking. There are
no strategies that make it possible to determine accurately where a single patient is
on the elastance curve.
In the intensive care unit, continuous intracranial pressure monitoring usually
presents the pressures as mean pressure in numerical values, or as a curve that has
to be visually analyzed. Though single waves may be displayed on the monitor,
strategies to explore trends in changes of single wave characteristics are lacking.
Furthermore, strategies to continuously examine compliance solely on the basis of
the pressure curves have not been established.
There is a close relationship between blood pressure and intracranial pressure as
the intracranial pressure waves are built up from the blood pressure waves.
Simultaneous assessment of intracranial pressure and blood pressure provides
several advantages, for instance by calculation of the cerebral perfusion pressure
(that is mean arterial pressure minus intracranial pressure). The assessment of
cerebral perfusion pressure represents a critical parameter in the monitoring of
critically ill patients. Assessment of blood pressure per se also has a major place in
daily clinical practice, including both assessments of diastolic and systolic
pressures.
SUMMARY OF THE INVENTION
On this background the applicant developed technical solutions for monitoring
pressures in patients that are free to move about, for accurate digital sampling and
analysis of pressure recordings, as well as a technical solution for comparing
pressure recordings within or between individuals.
An apparatus was developed allowing direct communication between the pressure
transducer and a computer (that is add-on to computers such as medical device
computers, vital signs patient monitors, or as a stand-alone system for sampling of
pressure recordings). Furthermore, a new algorithm for sampling, analysing and
presenting pressure recordings was developed and incorporated in computer
software. The computer software records, samples, analyses, and provides various
outputs of the pressure recordings. The technical solution may be applied to a
variety of pressures such as intracranial pressures (or cerebrospinal fluid
pressures), blood pressures, or other body cavity pressures. Invasive or non-
invasive sensors may record pressures.
With regard to sampling, analysis and presentation of single pulse pressure waves,
relative differences in pressures and relative time differences are computed. The
analysis is not relative to the zero level or the atmospheric pressure, therefore the
results of data analysis are not affected by the zero level or drift of zero level.
With regard to single pulse pressure waves, the invention provides measurement
and analysis of the following parameters:
a) Minimum is defined as the diastolic minimum pressure of the single wave, or as
the valley of the wave.
b) Maximum is defined as the systolic maximum pressure of the single wave, or
defined as the peak of the wave.
c) Amplitude is defined as the pressure difference between the systolic maximum
pressure and the diastolic minimum pressures during the series of increasing
pressures of the single wave.
d) Latency is defined as the time of the single wave when the sequence of pressures
increases from minimum pressure to maximum pressure.
e) Rise time is defined as the relationship between amplitude divided by latency,
and is synonymous with the rise time coefficient.
f) Wavelength is defined as the duration of the single pulse pressure wave when
pressures changes from minimum and back to minimum, and reflects the heart rate.
As mentioned in the Related Art section, amplitude, latency and rise in the present
invention is referring to the first peak (P1). This does not represent a limitation of
the scope of the invention, however, as amplitude, latency and rise time also may
be calculated for the second (P2) and third (P3) peaks as well.
By means of the invention the applicant showed that quantitative analysis of
characteristics of single pulse pressure waves revealed important and new
information about the pressures. Both these latter parameters are important for
assessment of abnormal pressures. The applicant has demonstrated (not published)
that parameters of the single pulse pressure waves analyzed and presented
quantitatively, provide information about compliance and elastance.
The quantitative method was developed for various pressures such as blood
pressure, intracranial pressure (subdural, epidural, intraparenchymatous, or
cerebrospinal fluid pressure), and cerebral perfusion pressure.
Furthermore, the quantitative method was developed for offering different types of
data presentations:
a) matrix presentations of numbers or percentages of single pulse pressure waves
with pre-selected characteristics during a recording period,
b) graphical presentations of single pulse pressure waves with the opportunity to
compare single waves, either between individuals, against a reference material or
within the same individual at different time intervals,
c) various types of statistical handling of the data are possible.
In a first aspect of the invention, the method for analyzing comprises the inventive
steps of:
identifying from said digital data features related to single pressure waves in said
pressure signals,
- said identifying step including determination of a minimum pressure value
related to diastolic minimum value and a maximum pressure value related to
systolic maximum value, and
- determining at least one parameter of the single wave parameters elected from
the group of: pressure amplitude = ?P = [(maximum pressure value) —
(minimum pressure value)], latency (?T), rise time or rise time coefficient =
?P/?T, and wavelength of the single wave, and
- comprising the further step of:
determining numbers of said single pressure waves occurring during a given
time sequence,
wherein said determining of numbers includes:
determining numbers of single pressure waves with pre-selected values of one
or more of said single pressure wave parameters during said given time sequence,
and
further includes determining numbers of single pressure waves with pre-
selected combinations of two or more of said single pressure wave parameters
during said given time sequence.
Further embodiments of this first aspect of the invention are defined in sub-claims
2-33.
In a second aspect of the invention, the method for analyzing comprises the
inventive steps of:
wherein the method comprises the further steps of:
- identifying from said digital data features related to absolute pressures relative
to atmospheric pressure,
recording repeatedly at specific time intervals, intermittently , in any reiterated
manner, or continuously absolute pressure data to create a pressure trend plot
against time,
- determining from said recording a number of different pressure levels and
duration thereof, and
presenting the numbers of levels of various time durations in said matrix
format.
Further embodiments of this second aspect of the invention are defined in sub-
claims 35 - 43.
In the context of the invention there is disclosed apparatus to provide for recordal
of signals indicative of the intracranial pressure or blood pressure from various
sources of signals, that is invasive implanted microtransducers and non-invasive
devices using acoustic or ultrasonic signals, or other signals recorded by non-
invasive devices. Thus, the algorithm for analysis of pressures may be used
whether pressure signals are derived from invasive or non-invasive devices.
The invention is useful for monitoring intracranial pressures without being
dependent on the zero level (i.e. calibration against the atmospheric pressure). This
is particularly important for pressure sampling by means of non-invasive sensors.
An object of the invention is to provide a solution for analysis and presentation of
continuous intracranial pressure recordings obtained by non-invasive sensors.
Through use of proper software it is possible to perform quantitative analysis and
presentation of continuous pressure recordings representing e.g. intracranial
pressure, blood pressure and cerebral perfusion pressure. The software has several
options for quantitative description of the data, including calculation of a matrix of
pressure elevations of different levels and durations, or a matrix of pressure
changes of different levels and durations, or a matrix of numbers of single pulse
pressure wave parameters with selected characteristics.
The main objectives of the invention are related to intracranial pressure and blood
pressure, but this is not a limitation on the scope of the invention. The invention
can also be utilized in connection with pressure sensors measuring pressure in
other body cavities (such as the cerebrospinal fluid cavities).
In a process for obtaining pressure signals and carrying out analysis thereof, one or
more pressure sensors are applied to a patient and the pressure signals from the
sensors are sampled at selected intervals. The sampled signals are converted to
digital form and stored along with a time reference that makes it possible to
evaluate the change of pressure over time. The time reference may be stored as part
of the digital value, or it may be associated with the memory position, or memory
address, at which the pressure value is stored. The stored sample values are then,
according to this embodiment of the invention, analyzed in order to generate a
presentation of at least one of the following: number of pressure elevations with
any selected combination of level and duration; number of pressure changes with
any selected combination of level difference and duration of change; and number of
pulse pressure waves with preselected characteristics regarding minimum,
maximum, amplitude, latency and rise time. This allows for various sampling rates
and duration of measuring periods. Assessment of single pulse pressure waves
preferentially requires a sampling rate of 100 Hz or above. As an alternative to
numbers, percentages may be computed. Any point of the single waves may be
calculated, and different parameters of the waves may be computed. There is a
fundamental difference between computation of number of pressure elevations with
any selected combination of level and duration and number of pulse pressure waves
with preselected characteristics regarding minimum, maximum, amplitude, latency
and rise time. One way is thereby to compute pressures relative to a zero level (i.e.
atmospheric pressure), whereas a second way is to compute relative differences in
pressures and time and therefore is independent on the zero level.
In the context of the invention there is provided a system for handling single pulse
pressure waves in a way that pressures from a single subject may be superimposed
on the pressure-volume (elastance) curve providing information about the
elastance. This solution provides one of several strategies of early detection of
decompensation of pressures, before the conventional methods.
In the present disclosure there is described a system for quantitative and accurate
comparisons of pressure recordings/curves when assessing pressure in a body
cavity or blood pressure. Comparisons may be made between different continuous
pressure curves that include different recording periods, different heart rates, as
well as different zero levels. Comparisons of continuous pressure recordings may
be made both between individuals and within individuals (that is before and after
treatment or comparisons of pressure recordings at different time intervals). This
system makes use of a newly developed algorithm (not further disclosed) in a
computer software. The algorithm includes quantitative approaches for analysis of
the pressure recordings and strategies to present the recordings. The system may be
integrated in commercially available pressure transducer devices, in computer
servers or in medical device computers or in the portable apparatus for pressure
monitoring described here.
The technical solution of comparing various continuous pressure curves involves
standardisation procedures. The numbers/percentages during a given recording
period may be standardized to numbers/percentages during a standardized
recording period (e.g. one or 10 hours) and a standardized heart rate. For different
individuals the quantitative data for a given recording period may be standardised
to a selected recording period (for example numbers/percentages during one
minute, one hour or 10 hours recording period), as well as standardised to a
selected heart rate (for example heart rate of 60 each minute). Thereby, continuous
pressure recordings for different individuals may be compared.
In the context of the invention, there is disclosed a system for performing the
analysis according to the method. The system may be in the form of a suitably
programmed computer, or dedicated equipment particularly designed for
performing this analysis. The system includes a communication interface for
receiving a set of digital pressure sample values, a memory for storing these values,
and a processor for performing the analysis described above. The system further
includes a video interface that is controlled by the processor and that is capable of
generating a visual presentation of the result of any analysis performed by the
processor. The visual presentation will be presented on a display. The system also
comprises input means for allowing a user to change the parameters of the
performed analysis. This implies that the system may be integrated in different
computer servers, medical device computers or vital sign monitors. Therefore, the
system described here represents no limitation by which the invention may be
applied.
The output computed by the software may be presented in a number of ways,
including matrix of numbers, graphical presentations, and comparisons of pressures
in an individual against a reference material or against previous recordings of the
individual.
Further exemplifying features and embodiments of the invention as well as other
aspects of and relations thereto will now be described in the following description
with reference to the attached drawings.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
FIG. 1 is a block diagram of the various components of a system according to the
invention.
FIG. 2 is a graphical user interface used for presenting pressure-sampling results.
FIG. 3 is a graphical user interface for presenting and controlling the analysis of a
pressure curve.
FIG. 4 shows a part of the graphical user interface of FIG. 3 for different levels and
duration's.
FIG. 5 is a graphical user interface for presenting pressure-sampling results.
FIG. 6 is a presentation of comparisons of pressure curves within an individual.
FIG. 7 is a presentation of the parameters measured during analysis of single pulse
pressure waves.
FIG. 8 are parts of graphical user interfaces for presentation of single pulse
pressure waves.
FIG. 9 are graphical user interfaces for presentation of pressure recordings and
parameters of single pulse pressure waves during an infusion test.
FIG. 10 is a presentation of comparisons of parameters of different types of single
pulse pressure waves.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
FIG. 1 illustrates in a block diagram a system for measuring pressure in a body
cavity of a patient. The main components of this system includes a pressure sensor
16, a pressure transducer 2, a portable apparatus for measuring and storing pressure
values 1, and a network station such as a personal computer 6 for receiving and
processing registered pressure values. The apparatus 1 is a digital system with a
central processing unit 8 for sampling and storing pressure measurements in a
patient, such as intracranial pressure, blood pressure or pressure in other body
cavities or blood pressure. In the following example an embodiment for measuring
intracranial pressure will be described, but it must be understood that this is not a
limitation on the scope of the invention.
Most commercially available sensors 16 give an analogue signal on the basis of a
mechanical action on the sensor. Within the pressure transducer 2 the signals from
the sensor is converted to a signal that may either be a voltage or current signal.
The pressure transducer 2 then produces a continuous voltage or current signal.
The voltage or current signals from the transducer are further processed within the
signal conditioner 5. The analogue signals are converted to digital signals within
the analogue to digital converter 7. Certainly various modifications are possible.
When data are collected from for example a vital signs monitor both the pressure
transducer 2 and the analogue to digital converter 7 may be built into the vital signs
monitor. The digital signals are handled according to the invention.
The apparatus 1 may be constructed in a number of ways. The embodiment
described below is based on a unit with a central processing unit 8 operating in
accordance with instructions stored in memory 9 and communicating with the
various parts of the apparatus over a common data bus 14. However, a number of
variations are possible. Instead of using a central processing unit 8 and instructions
stored in memory 9, the functionality of the apparatus 1 could be constructed
directly in hardware, e.g. as ASICs. The apparatus represents no limitation for the
use of the system for the analysis and presentation of pressures described here.
The main components of the apparatus 1 are then the analog to digital converter 7,
which converts the received analog measuring signals to digital, the data memory
9, which receives the digitized values from the analog to digital converter 7 and
stores them. An input/output interface 15 allows data stored in the memory 9 to be
transferred to the network station or personal computer 6 for processing. The
apparatus preferably includes a galvanic element 3 protecting the patient from the
electric circuitry of the apparatus, a signal conditioner 5 either to the input or the
output of the analog to digital converter 7, an input control 10 for controlling
operation and adjusting settings of the apparatus, a display unit 12, and an alarm
unit 13. Input control 10, display 12 and alarm unit 13 are connected to and in
communication with the central processing unit 8 and/or other parts of the
apparatus such as ASICs, display drivers, and power sensors (not shown).
After being received by the apparatus over a connector 4 to which the pressure
transducer 2 is connected, analog measuring signals are sent to a signal conditioner
5. Preferably a galvanic element 3 is positioned between the interface 4 and the
signal conditioner 5, representing a security element preventing electrical energy
from being sent retrograde to the patient. Signal processing in the conditioner 5
modifies the signal-to-noise ratio. This is required since a high degree of noise can
be expected for instance during walking. The signal conditioner 5 may be an analog
filter. Alternatively, the signal conditioner 5 may be a digital filter operating under
control of the central processing unit 8. The signal conditioner 5 will then be
positioned following the conversion of the sampled signal from analog to digital.
Besides, the software computes the number of artifacts during a recording period,
and the artifact ratio. The program includes an option for excluding recordings
when the artifact ratio is above a selected level.
As has already been mentioned, the apparatus 1 is here described as receiving
signals indicative of the intracranial pressure from sensors 16 implanted within the
skull. However, the apparatus may also incorporate a signal conditioner 5 for
processing signals from non-invasive devices such as acoustic, ultrasonic or
Doppler devices. Whether the entire apparatus 1 must be constructed with a signal
conditioner 5 for a specific purpose or whether the same signal conditioner 5
allows for different uses, with or without re-programming, is dependent on
implementation and specific needs. If the apparatus 1 is intended to work with
various sensors 16 with various levels of sensitivity, the signal conditioner should
be adjustable in a manner that allows operation with the desired sensors and to
adapt the output range to the various sensors to the input range of the analog to
digital converter 7. In this case the signal conditioner 5 must obviously be
connected between the input of the apparatus 1 and the analog to digital converter
7.
The pressures may be recorded with variable sampling frequency, e.g. from about 1
- 10 Hz up to at least 150 Hz (most preferably between 100 and 200 Hz). When
single pulse pressure waves are monitored, the sampling frequency preferentially is
100 Hz or above. The minimum memory space should then allow storing of
recordings at least 150 times a second for at least 48 hrs (26 920 000 recordings).
Via a connector 11, data may be transferred to the personal computer 6 for
analysis. The connector 11 may be a serial port, and the apparatus will preferably
comprise an input/output interface 15 converting the internal signal format for the
apparatus 1 to a format for communication over said connector 11.
The various units of the apparatus are shown as communicating over a common
data bus 14, but it should be noted that the various components may be
interconnected in other ways.
The apparatus 1 has been described above with only one channel for receiving
pressure signals from one pressure sensor. The apparatus may, as mentioned
before, include one or more additional channels for receiving signals from
additional pressure sensors.
The invention also relates to a method for measuring and analyzing pressure in a
patient. This method will now be described.
First a signal from a pressure sensor 16 and transducer 2 representative of pressure
in a body cavity is received and sampled at selected intervals. This signal is
converted to digital form 7 and stored along with a time reference representative of
the time at which the sample was made 9. The time reference does not have to be a
time reference value stored for every sample. Since the sample rate will be known,
it will be sufficient to store an actual time reference for the start of the measuring
period. The time reference for the individual samples will then be given by their
relative address in memory.
The stored sample values may then be analyzed in order to generate a presentation
regarding a time period of at least one of the following:
- number of pressure elevations with any selected combination of level and
duration,
- number of pressure changes with any selected combination of level difference and
duration of change,
- number of single pulse pressure waves with pre-selected characteristics such as
minimum, maximum, amplitude, latency and rise time.
This type of analysis may be performed either on-line or off-line. During on-line
analysis, analysis is performed repeatedly and presented repeatedly during real-
time on-line monitoring. This allows for comparisons of pressure characteristics at
repeated intervals. Off-line analysis is performed after the recording period has
been ended.
In order to analyze number of pressure elevations with any selected combination of
level and duration occurring in a time period, the stored samples are simply
analyzed in order to determine for how long the measured pressure has remained
within a certain pressure interval. According to a preferred embodiment of the
invention, the user performing the analysis will be able to set the pressure intervals
defining the various levels and duration of pressure elevations manually and
perform the analysis repeatedly with different values for these parameters. Level
may be measured on a linear scale e.g. with intervals of 5 mmHg, while the time
scale intervals should preferably increase with time, e.g. each interval being twice
as long as the previous shorter interval.
An analysis of number of pressure changes with any selected combination of level
difference and duration of change would involve an analysis of the stored samples
in order to determine the size of a pressure change and the time over which the
change takes place.
An analysis of single pulse pressure waves will take into consideration not only
elevations that remain within a certain time interval, but the transition of a wave
from minimum to maximum and back to a new minimum or vice versa. Pre-
selected characteristics identifying a pressure wave of interest may be the duration
of the single pulse wave from minimum (maximum) back to minimum (maximum)
combined either with minimum value, maximum value or amplitude of the single
wave. Another pre-selected characteristic may be the rise time of the single wave.
The pressure sensor 16 may be applied by implanting the sensor in a body cavity of
the patient, but it may also be applied by a non-invasive technique with a sensor
using acoustic measuring signals, ultrasonic or Doppler, or even a pressure sensor
for measuring blood pressure. In general, a problem with non-invasive sensors
recording intracranial pressure, is the lack of a zero level since intracranial
pressure is calibrated against atmospheric pressure. The present invention solves
this problem by computing the relative differences in pressure during single
pressure wave analysis. Thereby the need for a zero level is excluded.
The computer is not shown in detail. It preferably includes a standard
communication interface for receiving a set of digital pressure sample values from
the apparatus described above, as well as data memory, such as a hard drive, for
storing the received sample values and processing means, such as a
microprocessor, with access to said data memory, and capable of analyzing said
sample values in order to determine at least one of the following: - number of
pressure elevations with any selected combination of level and duration - number
of pressure changes with any selected combination of level difference and duration
of change, - number of single pulse pressure waves with preselected characteristics
regarding minimum, maximum, amplitude, latency and rise time. The computer
further includes a video interface in communication with said processing means
and capable of, in combination with the processor means, generating a visual
presentation of the result of any analysis performed on the pressure sample values
together with a graphical user interface. The video interface may be a graphics card
connected to a display for displaying the generated visual presentation. The
computer will also include input means allowing a user of the system to enter and
change parameters on which said analysis should be based. These input means will
normally include a keyboard and e.g. a mouse, and the user will be assisted by a
graphical user interface presented on the display.
The parameters on which the analysis should be based may include at least some of
the following: pressure intervals defining a number of pressure elevations, pressure
change intervals defining a number of pressure change step sizes, time intervals
defining a number of durations, pressure wave characteristics including minimum,
maximum, amplitude and latency, selection of type of analysis, and selection of
presentation of numbers as absolute numbers, percentages or numbers per time
unit.
The operation of the computer 6 will preferably be controlled by computer program
instructions stored in the computer 6 and making the computer capable of
performing the analysis. The program will preferably be able to perform the
analysis based on default values in the absence of parameters input by a user. Such
a computer program may be stored on a computer readable medium such as a
magnetic disc, a CD ROM or some other storage means, or it may be available as a
carrier signal transmitted over a computer network such as the Internet.
FIG. 2 illustrates the graphical user interface of the computer software used for
presenting the results of the sampling described above. The software processes the
digital pressure signals. Before the continuous pressure recordings are presented in
the graphical user interface as shown in FIG. 2, the pressure signals are sampled
and averaged. With regard to FIG. 2, the sample update rate was in the range 30 to
100 Hz and the update rate (average interval) was in the range 1 to 5 seconds. The
update rates may vary between 1 - 10 Hz for low frequency sampling. Modern vital
signs monitors may offer a computer interface producing this type of averaging.
Various modules of the software generate output or can be invoked through this
interface. The intracranial pressure curve 34 may be presented in various windows.
The X-axis shows the time of registration 20, that is real time of intracranial
pressure sampling (presented as hours: minutes: seconds). The Y-axis 21 shows the
absolute intracranial pressure recordings (presented as mmHg). During the
recordings, it is possible to mark events (e.g. sleep, walking, sitting) and these may
be presented as symbols 22 along the X- axis above the pressure graph. There are
functions 33 for selecting the recording periods, for instance selecting parts of the
intracranial pressure curve during sleep, walking, sitting etc. There are functions
for selecting different window sizes 23 both vertically and horizontally. The curve
34 presented in the window in FIG. 2 represents about 21 hours recording time
(that is actual recording time). A special function 24 allows simple statistical
analysis of the data presented in the window (with calculations of mean, standard
deviation, median, ranges and time of recording). Another function 25 transfers to
a software module that performs quantitative analysis of a single intracranial
pressure curve in accordance with the invention. The results of this analysis are
described below with reference to FIG. 3-6. Another function 26 allows export of
intracranial pressure data from a selected window to files with a selected text
format such as ASCII, that can be utilized by e.g. spreadsheet or word processing
applications. The intracranial pressure curve may be smoothened by another
function 27. Another function allows printing of the intracranial pressure curve 28.
The software also includes a function for patient identification 29 also containing
some data of the patient (such as tentative diagnosis and cause of examination). In
addition, there are start 31 and stop 32 buttons for controlling the sampling
process. If the apparatus has collected pressure samples from several pressure
transducers 2, e.g. intracranial and blood pressure, these may be simultaneously
analyzed. The functions are linked up to the pressure recordings displayed in the
window. Any type of pressure may be presented in this way.
The size of the window, that is the observation time may be changed to reveal the
single pulse waves. Each single pulse wave is built up from a blood pressure wave.
Comparable to the heart rate, during one minute of recording often about 50-70
single pulse waves may be recorded. There is, however, a large variation in heart
rate both between and within individuals, accordingly there is a variation in the
numbers of single pulse intracranial or blood pressure waves during one minute
recording.
The functions referred to above and the software modules that perform them will
not be described in detail as they are well known in the art and do not constitute a
part of the invention as such.
Reference is now made to FIG. 3 which shows the graphical user interface of the
software module for analysis of the intracranial or blood pressure curve, or other
pressures in human body cavities. The selected window of the intracranial pressure
curve 34 is presented as a chart or matrix 35 of quantities of different types,
derived through the invented method of analysis. Any size of the recording period
33 represented by the window may be selected for the quantitative analysis. A
similar user interface is used independent on the type of pressure measured.
The mathematical functions may be implemented in the software by various routes.
One implementation is shortly described. The data needed for analysis of pressure
elevations of different levels and durations include the pressure recordings and the
corresponding time recordings. Two variables are selected, namely the threshold
levels (pressures expressed in mmHg) and the width (time expressed in seconds).
A search is made for both peaks (positive-going bumps) and valleys (negative-
going bumps), and the exact levels of peaks and valleys are identified. Peaks with
heights lower than the threshold or valleys with troughs higher than the thresholds
are ignored. For a threshold value less or equal to zero a valley search is
performed. For threshold values greater than zero a search for peaks is performed.
The peak/valleys analysis is performed for every with/threshold combination in the
matrix. In short, the procedure is as follows. The part of the pressure curve 34 that
is to be examined is selected 33, the data is visualised in the user interface. A
suitable width/threshold matrix is selected, specifying the with/threshold
combinations. The units used are time in seconds (width) 37, and pressure in
mmHg (threshold) 36, respectively. The software records the numbers of samples
that fit a given width/threshold combination. The output from the analysis is a
matrix containing the numbers of all the different width and threshold
combinations. An example of such a matrix 35 is given in FIG. 3. As shown in the
matrix 35, the width/threshold combination 20 seconds/25 mmHg (that is ICP
elevations of 25 mmHg lasting 20 seconds) occurred 63.00 times during the actual
recording time of 21.10 hours 45. In this matrix the numbers were not standardised
to a selected recording period 42. The pressure elevations are relative to the zero
level that corresponds to the atmospheric pressure.
By clicking a first button 38, the user can select a presentation of the data as a chart
of numbers of intracranial pressure elevations with various combinations of level
36 and duration 37. The intracranial pressure levels and durations may be selected
in each case. According to a preferred embodiment, intracranial pressure is
expressed as mmHg and duration as seconds and minutes. Also blood pressure may
be expressed as mmHg. Independent of the type of pressure measured the pressures
may be presented in the same way.
A second button 39 allows the user to select presentation of the data as a chart of
numbers of intracranial pressure intracranial pressure changes of different levels 36
and duration 37. The changes may be differences between two recordings or
differences between a recording compared to a given or selected value (e.g. mean
pressure).
By clicking a third button 40, the user selects presentation of the data as numbers
of single pulse pressure waves with pre-selected characteristics. The user accesses
an input dialog box for entering these characteristics by clicking a fourth button 41.
Each single pulse pressure wave is identified by minimum, maximum, amplitude,
latency and rise time. Further details about analysis and presentation of the
parameters of single pulse pressure waves are given in FIG's. 7-10.
The presentation of the results of the analysis in chart 35 may be toggled between
absolute numerical quantities and percentages of recording time by clicking one of
two buttons 44.
The numbers may be standardized by presenting the data as numbers per time unit
42. The time unit (e.g.) may be selected in each individual case. The data presented
in FIG. 3 was based on a recording time of 21.1 hrs (actual recording time 45), and
the recordings were not standardized in this case (represented by zero in
standardization input box 42). It should be noted that standardization may be
performed to various time units, such as each one minute, one hour or even 10
hours. Since the calculation of single pulse pressure waves automatically also gives
the heart rate it is possible to standardize the numbers according to a given heart
rate (further details given in FIG. 7). For example, the numbers may be
standardized to a given heart rate of 60/min.
During on-line presentation the matrix 35 may be compared repeatedly. The whole
matrix 35 may not need to be presented but only certain width/threshold
combinations. Differences between certain combinations at different time intervals
may be revealed. For example, the numbers or percentages of intracranial pressures
of 15, 20 and 25 mmHg lasting 5 minutes during 1 hour recording period may be
computed and presented each hour during on-line presentation. Normalization of
data to a standardized recording time 42 and heart rate allows for accurate
comparisons between different time intervals for individual cases, as well as
comparisons between individuals.
Again, a special function 43 allows the analyzed data to be saved as text files with
a selected text format such as ASCII, or other files compatible with applications for
mathematical and/or statistical handling of the data or for generating presentations.
FIG. 4 shows part of the graphical user interface of FIG. 3 with a different set of
parameters. In particular, the various time intervals of duration 37 have been
changed, and the matrix 35 shows numbers of elevations normalized as number of
occurrences per time unit 42. In this case the numbers are derived from a
standardized recording time of 10 hours 42, with the actual recording period 9.01
hrs 45.
The results shown in FIG. 3 are the results of an analysis of number of pressure
elevations with selected combinations of level and duration. As indicated in FIG. 4,
the stored samples have been analyzed in order to determine for how long the
measured pressure level 36 has remained within a certain pressure interval,
represented as -10, -5 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45 mmHg relative to
atmospheric pressure, for certain periods of time 37. The various periods of time
37 are selected as 30, 60, 300, 600, 1200 and 2400 seconds, respectively. In FIG. 4,
the results have been normalized to numbers during a 10 hours recording period 42.
Among the results in the result matrix 35 it can be seen that intracranial pressure
elevations of 45 mmHg with a duration of 30 seconds have occurred 8.88 times
when normalized to a 10 hour measuring period. Similarly, pressure elevations of
30 mmHg with a duration of 600 seconds have occurred 2.22 times when
normalized to a 10 hrs recording period. In FIG. 3, where the results are not
normalized, all the results are integers.
During the standardisation procedure, the numbers or percentages are adjusted to a
given factor. The normalised time may be chosen in each individual. An example is
given. If the actual recording time is 6 hours, a standardisation to 10 hours
recording time implies that all numbers or percentages of pressure elevations are
multiplied with a factor equal to 10/6 (that is 1.66666).
The following example is intended to illustrate various aspects of the present
invention regarding related measurements of pressure waves described in FIG.'s 2-
4, but is not intended to limit the scope thereof.
FIG. 5 shows the same part of the graphical user interface as FIG. 4, but in this
case the analysis is an analysis of number of pressure with selected combinations
of level difference 30 and duration of change 37. The stored samples have been
analyzed in order to determine the number of pressure changes of certain sizes 30,
represented as -20, -15, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 mmHg relatively, and the
duration 37 over which these changes take place, given as 10, 15, 20, 25, 30, 35,
40, 45 and 50 seconds. Among the results given in the result matrix 35 it can be
seen that a pressure change of 2 mmHg that takes place over a 15 seconds has
occurred on average 1.14 times per 10 hour period. Changes of 0 mmHg represent
periods of time over which the pressure has remained constant. Also in this matrix
the numbers have been standardized to numbers during a 10 hours recording
period. The standardization procedure gives the opportunity to compare pressure
curves, either within individuals at different time intervals or between individuals.
The procedure of comparing pressure curves 34 is further illustrated in FIG. 6. The
pressure curves before (left) and after (right) surgery are shown, and below the
matrix 35 of numbers of pressure elevations. The numbers are standardized to a 10
hrs recording period 42. This example is intended to illustrate various aspects of
the invention described in FIGS. 2-6, but is not intended to limit the scope thereof.
Continuous intracranial pressure monitoring was performed in a 3 years and 10
months old boy due to suspected premature closure of the cranial sutures. The boy
had symptoms of increased intracranial pressure. During sleep the data of the
intracranial pressure curve were as follows: Mean intracranial pressure 15.4
mmHg, range 0-57.1 mmHg, std 6.0 mmHg, and time of pressure recording 480
min (8.0 hrs). On the basis of the results of intracranial pressure monitoring,
surgery was performed. A cranial expansion procedure that is a rather major
procedure was performed to increase the cranial volume and thereby reduce
intracranial pressure. However, after surgery the patient still had symptoms of
intracranial hypertension. Therefore it was decided to repeat the intracranial
pressure monitoring, that was undertaken six months after surgery. The data for
this monitoring during sleep were as follows: Mean intracranial pressure 15.2
mmHg, range 5.5-39.4 mmHg, std 3.9 mmHg, and time of intracranial pressure
recording 591 min (9.85 hrs). This new intracranial pressure monitoring Was
inconclusive because mean intracranial pressure was unchanged after surgery. In
retrospect, the monitoring of intracranial pressure was without purpose since no
conclusions could be drawn on the basis of the pressure recordings. Though the
pressure was unchanged after surgery, it was decided not to perform a new
operation though the results of intracranial pressure monitoring did not document
any reduction of intracranial pressure after cranial expansion surgery. A "wait and
see" policy was chosen on the basis of intracranial pressure monitoring. However,
when the method according to the present invention was applied retrospectively to
the intracranial pressure curves before and after surgery, it was found a marked and
significant reduction of number of intracranial pressure elevations. The matrix 35
of numbers of intracranial pressure elevations of different levels 36 and duration's
37 before and after surgery is presented in FIGS. 6a and 6b, respectively. In
FIGS. 6a, 6b both the intracranial pressure curve and the corresponding matrix 35
of intracranial pressure elevations of different levels 36 (20 - 45 mmHg) and
durations 37 (0.5 - 40 minutes) are presented (before surgery at left and after
surgery at right). The matrix 35 is presented as numbers during a standardised
recording time of 10 hours 42 (actual recording time 45 before surgery 8 hours and
after surgery 9.85 hours). The results documents that surgery had a major effect in
reducing the number of intracranial pressure elevations despite an unchanged mean
intracranial pressure. After surgery, there were no elevations of 40 or 45 mmHg,
the number of elevations of 25, 30 or 35 ramHg were markedly and significantly
reduced, whereas the number of intracranial pressure elevations of 20 mmHg were
not significantly changed. For example, during a standardized recording time of 10
hours, intracranial pressure elevations of 30 mmHg lasting 1 minute occurred 30
times before surgery (left matrix) and one time after surgery (right matrix). Various
statistical methods may be applied to the data to identify statistically significant
changes. Accordingly application of this method would have justified no re-
operation in a stronger and more reliable way. The patient has been followed for an
observation period of 2 years without surgery and has shown a satisfactory
development in this period.
In FIGS. 2-6 changes in the pressure curves of longer duration (30 seconds or
above) have been illustrated. Though reference has been made to intracranial
pressure, this represents no limitation of the invention. Pressures from other body
cavities may be presented in the same way.
In the following FIGS. 7-10 the invention applied to single pulse pressure waves is
described. Analysis of single pulse pressure waves represents an even more
detailed strategy for comparing pressures between and within individuals.
With regard to data collection, several steps are basically similar to the processes
described for FIGS. 2-6. The signals from the sensor are converted to either a
continuous current or voltage signal that is further processed in the apparatus 1 or
modifications thereof. The continuous current or voltage signals are converted to
digital signals within the analogue to digital converter. Another approach is to
collect data from a vital signs monitor. Different from the data presented in FIGS.
2 - 6 a higher sampling rate is required for analysis of single waves. With regard to
single wave analysis the crucial point is to have a sufficient sample rate, as well as
sufficient resolution order to reproduce the pressure waveform properly. According
to the experience of the inventor so far a sampling rate of at least 100 Hz is
sufficient to find maximum and minimum values an calculate latency, amplitude
and rise time for the first peak (P1) (see FIG. 7). A higher sampling rate (at least
200Hz) is required to compute the latencies and amplitudes of the second (P2) and
third (P3) peaks. It is required that the analogue to digital converter has a
resolution of at least 12 bits. It is preferably to use 16 bits or higher.
Reference now is given to FIG. 7, demonstrating the parameters of a single pulse
pressure wave that are analyzed quantitatively. All pressure signals are recorded,
usually with a recording frequency of 100 Hz or above. The window with single
pulse pressure waves (see FIG.7a) is opened by pressing button 40 (see FIG. 3).
The single waves are defined by the maximum 46 and minimum 47 values. By
pressing another button 41 (FIG. 3), the following parameters (see FIG. 7b) at any
point on the single pressure curve may be computed: Amplitude 48, latency 49, and
rise time 50.
Latency 47 represents the time interval during which the pressure is changed from
one pressure to another pressure. Each pressure signal may be identified on the
time scale because pressures are recorded along with a time reference. The
maximum 46 and minimum values 47 identify each single wave. The latency from
one minimum 47 value back to another minimum 47 value is the heart rate and the
duration of the wave. The latency from minimum 47 to maximum 46 is the time
where the pressure of the single wave increases from the diastolic to the systolic
pressure.
People skilled in the art would know that a single intracranial pressure wave
contains three peaks, the first (P1), second (P2) and third (P3). The second peak
(P2) also is termed the tidal wave and the third peak (P3) the dichrotic wave.
Whether the waveform is reproduced properly or not depends on a sufficient
resolution order and a sufficient sampling rate. The expressions amplitude 48,
latency 49 and rise time 50 are with reference to each of these peaks. The
identification of the first peak (P1) is relative to maximum 46 and minimum 47.
The identification of the second peak (P2) also is relative to the first peak (P1),
and the third peak (P3) is relative to the second peak (P2). In the present
embodiment focus is given to amplitude, latency and rise time related to the first
peak (P1), though this does not represent any limitation of the scope of the
invention. References may also be to the second (P2) and third peaks (P3).
For the first peak (P1), the amplitude ?PI represents the relative pressure
difference between the diastolic minimum 47 and systolic maximum 46 pressures.
Latency ?TI is the time interval by which pressures increase from diastolic
minimum 47 to systolic maximum 46. Rise time ?PI /?TI is the quotient between
difference in pressure divided by difference in time. The differences of pressures
and time represent relative values. Any type of relationship may be calculated. The
software allows the calculation of a matrix 53 of number of single pulse pressure
waves (see FIG. 7c) with pre-selected wave characteristics of different amplitude
51 and latency 52. Any kind of combinations of single wave parameters may be
computed within the matrix 53. The amplitudes 51 usually are expressed in mmHg
and the durations 52 in seconds.
The results may be presented as absolute numbers or as percentages, and the
results may be standardized to a selected recording time (for example each one
minute, one hour, or even 10 hours recording time) 42, as compared to the actual
recording period 45. During the standardisation procedure, the numbers or
percentages of single waves with selected parameters are adjusted to a factor. The
normalised time may be chosen in each individual. An example is given. If the
actual recording time is 6 hours, and it is desired to standardise to 5 minutes
recording time, the function implies that all numbers of single waves are divided
with a factor equal to (6 x 60)/5 (that is 72.0). (See FIG. 7d)
Calculation of single pulse pressure waves automatically gives the heart rate
because each intracranial single pulse pressure wave is built up from the blood
pressure wave. Therefore the numbers of single waves with certain characteristics
during a given recording time also may be standardized to a given heart rate 55, as
compared to the actual heart rate 54. During the procedure of standardisation to a
given heart rate, the heart rate must be selected beforehand. The recording interval
also has to be selected, when an average of the heart rate must be computed. An
example is given, though this is not intended to limit the scope of the invention. It
is chosen to standardise the numbers or percentages of certain single waves to a
heart rate of 60 beats a minute. Furthermore, it is chosen to average the heart rate
to each 5-second recording period. During this recording period of 5 seconds the
averaged heart rate is computed. Given that the total continuous recording period is
6 hours this standardisation analysis has to be repeated a total of 4320 times
(xl2/minute, x720/hour). Given that the actual average heart rate is 120 beats a
second in a 5 seconds interval, the numbers or percentages of single waves during
the period of 5 seconds must be divided by 2, to be standardised to a average heart
rate of 60 beats a second. On the other hand, if the average heart rate is 30 during
the 5 seconds interval the numbers or percentages of single waves during these 5
seconds has to be multiplied with a factor of 2, to be standardised to a heart rate of
60 beats a second. This approach also allows for on-line and real-time update of
standardised numbers or percentages to a given heart rate since such an update may
be performed repeatedly every 5 seconds.
With regard to presentation of single wave parameters, a number of variations are
possible. The matrix 53 of pre-selected characteristics of amplitude 51 and latency
52, may be presented repeatedly and comparisons between matrixes 53 at different
times may be performed. Only certain single wave parameters may be compared.
The numbers/percentages of single wave parameters may be subject to any type of
statistical analysis.
FIG. 8 illustrates the computation of single pulse pressure waves with certain pre-
selected characteristics. The mathematical process of quantitative analysis of single
wave parameters may be implemented in the software in various ways, one strategy
of implementation is described here. The acquired signal is first run through
separate detection of minimum 47 and maximum 46 values. The maximum
threshold value is set to the lowest level in the signal, and width greater than pre-
selected seconds. A variety such pre-selected seconds may be chosen, and the
values may depend on age. In the first studies, durations of 0.1-0.2 seconds were
used, but other durations may also be used. The minimum threshold is set to
highest signal level, and the width is set to pre-selected seconds, as described
above. After this analysis all maximums 46 and minimums 47 are represented with
an amplitude value and a location value or time stamp. The locations are reported
in indices from the start of processing. This procedure will result in a lot artificial
maximum and minimum detections. In other words the maximum 46 and minimum
47 detection has to be refined. After this is done the result is a collection of
approved maximum and minimum pairs, which in the next turn can be presented to
the function handling the dynamic parameter analysis. First, grouping of the
maximum values and minimum values is performed. For every maximum 46 the
subsequent minimum 47 is found. This couple makes a maximum-minimum pair.
The latter maximum-minimum pair is inspected for threshold level. The threshold
value has to be larger than a given value. This is performed by subtracting the
maximum amplitude and minimum amplitude. If this value is less than the
threshold value the pair is discarded. Afterwards the pair is inspected for the rise
time (?PI/?TI). The rise time is expressed as maximum amplitude minus
minimum amplitude divided by maximum location minus minimum location. This
will remove pairs caused by for example an artefact in the collected signal. All rise
time values with a value equal or larger than a given value is discarded. A large
variation is possible with regard to rise times that are discarded. The collection of
maximums and minimum's contained now only approved values. All the dynamic
values are calculated by using the approved maximum-minimum pairs. The values
which are calculated are amplitude (?PI) (delta intracranial pressure expressed in
mmHg) 51, latency (?TI) 52, and rise time (?PI/?TI) 59, and heart rate 58. All
these values are quite forward to find using the information found in the approved
maximum-minimum pairs. The collections of amplitude (?PI) 51 values give
information constituting the matrix column information. The collections of latency
(?TI) values 52 give the matrix row information. A matrix 53 of different
amplitude 51 and latency 52 combinations is computed.
An important aspect with the computation parameters of single pulse pressure
waves is that the invention computes the relative differences in pressures and time.
These relative differences are not related to a zero level of pressure. Accordingly,
the single wave analysis is not influenced by the zero level of pressure, neither of
drift of the zero level of the sensor. It should be noted that the procedure of
calculating pressure elevations of various durations FIGS. 3-6 involves
computation of absolute intracranial pressures (or other pressures in a human body
cavity) relative to atmospheric pressure. The conventional methods of assessing
intracranial pressure use calibration against atmospheric pressure. The present
invention of computation of relative pressures of single pressure waves solves
several problems of known in the art.
(a) The impact of inter-individual and intra-individual differences in pressure is
reduced. When comparing continuous pressure curves between or within
individuals, a source of error may be differences in the baseline pressure due to
differences or drift of zero level. In the present invention, the accurate zero
level does not affect the single wave parameters computed.
(b) A drift in the zero level of the pressure sensor usually is a problem with
pressure sensors, particularly when pressure is monitored continuously for
several days. Drift in zero level of pressure has no influence on the single wave
parameters computed as described here.
(c) The major problem with continuous monitoring of intracranial pressure by
means of non-invasive sensors is the problem of determining a zero level.
Thereby relative differences in pressure must be computed, but the output give
non-accurate data since it may be nearly impossible to suggest the intracranal
pressure on the basis of such relative pressure assessments. In the present
invention it has been possible to accurately compute the single waves with pre-
selected characteristics of latency, amplitude and rise time. Since relative
differences are computed, there is no need for a zero level. When single waves
are computed by means of a non-invasive sensor, the present invention allows
for determination of the intracranial pressures with a high degree of accuracy.
On the basis of computing several hundred thousand of single waves and
comparing the single wave parameters with the mean intracranial pressure, a
high degree of correlation between amplitude, rise time and mean intracranial
pressure has been found. According to this invention, single wave analysis of
signals from non-invasive sensors may both give information about relative
changes in pressure and about the intracranial pressure, as the relationships
between intracranial pressure and single wave characteristics are known
beforehand, on the basis of a large number of comparisons. This process may be
as follows. A non-invasive sensor 16 may be applied to the patient and
connected to the transducer 2, and the signals are processed in the apparatus 1
or modifications thereof. Such sensors 16 may use acoustic or other signals, for
example by application of a sensor-device to the outer ear, sensing pressure in
the middle ear indicative of the intracranial pressure. The signals are converted
in the apparatus 1 and stored along with the time stamp. The computer software
handles the digital signals and performs the quantitative analysis of the
parameters of single pulse pressure waves described here. Without knowing the
exact zero level of intracranial pressures, changes of single wave parameters
may be followed continuously. This approach provides a simple approach to
follow changes in intracranial pressure, and obtaining accurate information
about the intracranial pressure.
(d) It is possible to implant permanently pressure sensors within the intracranial
compartment, for example in conjunction with ventricular shunts. Telemetric
devices may record pressures. Also with this type of pressure monitoring, drift of
zero level remains a problem, hence it may be a question of whether the correct
pressure is monitored. The present invention soles this problem as drift in zero
level does not affect the pressures recorded.
Exploration of the single pulse pressure waves is started by pressing the button 40,
and the single wave parameters are selected by pressing the button 41. FIG. 8a
shows the single pulse pressure waves 57, including the time recordings 20 along
the X axis, and pressure levels 56 along Y axis. On the Y axis the absolute pressure
values are shown, it should be noted, however, that the single pulse pressure waves
are calculated by computation of relative pressure and time differences. As
indicated on FIG,.8b, the single waves are identified by the minimum 47 and
maximum 46 values. For the first peak (P1), the amplitude (?PI) and latency
(?TI) are both indicated.
In FIG. 8c is also indicated the process of computing numbers of characteristics of
single pulse pressure waves. A graphical user interface reveals the curve of
intracranial pressure 34. A window revealing the pressure curve 34 along with the
absolute intracranial pressure recordings 21 and the time of registration 20 is
shown. The actual recording period 45 was 472.0 seconds, and the recording period
was not standardised 42 (0.00 in output box). During this period of recording the
numbers of single pulse pressure waves with pre-selected characteristics where
computed. The amplitudes of single waves 51 were selected to either 2.0, 2.5, 3.0,
3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 or 7.0 mmHg. The latencies of the single waves 52
were either selected to 0.23, 0.25, 0.26, 0.27, or 0.28 seconds. The numbers of
single pulse pressure waves with these pre-selected characteristics were computed
and presented in the matrix 53. For example, during the recording period of 472.0
seconds, single pulse pressure waves with an amplitude of 5.5 mmHg and a latency
0.28 seconds (that is rise time of 5.5/0.28 = 19.64 mmHg/sec) occurred 43 times
during this recording period. The results may be standardized 42 to a recording
time of for example 600 seconds. In this situation all numbers must be multiplied
with a factor of 600/472. The numbers also may be standardised to a selected heart
rate, as described above. A number of variations are possible with regard to
methods of data presentation.
The invention provides the option for comparisons of pressure curves. For
example, during monitoring of intracranial pressure during sleep the numbers of
single waves with certain pre-selected characteristics may be computed (for
example amplitude 4 to 8 mmHg and latency 0.25-0.28 seconds). The numbers of
such single waves may be computed during a standardized recording period (e.g.
each one minute or each one hour) and a standardized heart rate (e.g. 70/min). The
numbers of single waves may be computed within the same individual at different
times (e.g. before and after treatment) and compared. Alternatively the numbers of
single waves may be computed within an individual and the numbers may be
compared against a normal material.
FIG. 9a demonstrates the recordings of intracranial pressure (cerebrospinal fluid
which represent one of the compartments of the intracranial cavity) 34 while
infusing a liquid into the cerebrospinal space. Pressures are presented as absolute
values of mmHg on the Y axis 21 and time is expressed as seconds on the X axis
20. The intracranial pressure 34 is measured simultaneously with infusion of
physiological saline into the lumbar cerebrospinal space, which is termed infusion
test. It is shown how the intracranial pressure curve 34 increases as liquid is
infused. The increase of pressure is shown in the upper figure. FIG. 9b also
demonstrates the simultaneous computation of rise time 59-60 and heart rate 58.
With regard to rise time, two parameters are computed simultaneously, namely
?PI/?TI 59 and ?P1/?T2 60. It is shown that the rise times ?PI/?TI 59 and
AP1/AT2 60 increase with time. The heart rate 53, on the other hand, declines as
the pressure increases. This illustrates that the rise times may be calculated
repeatedly and plotted against time (X-axis). Alarm functions may be incorporated
for example alarming the occurrence of ?PI/?TI 59 above a given level. Rise time
may be an important predictor of abnormal pressure. The present technical solution
allows for computation of the exact numbers or percentages of single waves with
certain rise times during a given recording time. For example, the numbers or
percentages of single waves with a rise time between for example 10 and 30
mmHg/seconds during 5 minutes of recording may be computed repeatedly, and
presented graphically. FIG. 9a, 9b show some examples of presentation of single
wave characteristics, though the examples represent no limitation of the scope
It should be noted in FIG. 9b that heart rate declines as the rise time increases. This
is a physiological effect in the way that heart rate declines as a result of increased
decompensation related to increased pressure. Since the relative duration of each
single wave corresponds to the heart rate, the heart rate may be automatically
computed. The observation presented in FIG. 9b further illustrates the value of
concomitant recording of heart rate. The parameter heart rate provides additional
information about abnormality of intracranial pressure.
FIG. 10 shows strategies to compare pressure curves. The input box 40 (FIG. 3)
allows for comparisons of various single pulse pressure waves. In particular single
pulse pressure waves of intracranial pressure and blood pressure may be compared,
but any type of presure may be compared. The different pressure waves are
revealed simultaneously during real time on-line monitoring, with the identical
time reference. The output may be time on the X axis 20 and pressure 21 on the Y
axis. For example, the curve of single arterial blood pressure waves 61 may be
revealed simultaneously with the single intracranial pulse pressure waves 57, see
FIG. 10a. For a given recording period 45 the numbers of single pulse pressure
waves may be computed and the numbers may be standardised to a given recording
period 42. Furthermore the actual heart rate 54 may be standardised to a
standardised heart rate 55. (See Fig. 10d). The curves of single pulse intracranial
57 and arterial blood pressure 61 waves are presented in the upper figure to the
right. The time reference 20 is identical, thus allowing comparisons of single pulse
pressure waves at identical points of time. The Y axis reveals the absolute blood
pressure 62 and intracranial pressure 56 values. Reference is here directed to FIG.
10b. As described for intracranial pressure, a matrix may be computed with the
opportunity to define relationships between parameters of different single waves.
In the lower figure to the left is shown a matrix 65 (FIG. 10c) defining numbers of
relationships between rise time for intracranial pressure waves (?P1-1/?T1-l) and
rise time of blood pressure waves (?P1-2/?T1-2). This relationship (?P1-1/AT1-1)/
(?P1-2/?T1-2) has been computed and the matrix 65 presents the numbers by which
this relationship was 1,2, 3, or 4. This example represents no limitation concerning
the relationships between single waves that may be computed.-
The computer software may be integrated in the portable apparatus 1, as well as in
a network station, a personal computer, medical device computers 6, computer
servers 6 connected to vital signs monitors, or incorporated directly in vital signs
monitors. Output from the quantitative analyzes may be presented on the monitor
screen, flat screen or other devices known in the art.
Various modifications of the apparatus 1 are possible. Components of the apparatus
1 may be integrated in the pressure transducer 2 or in various types of computers
including medical device computers 6.
Though focus is given to intracranial pressure (including cerebrospinal fluid
pressure), blood pressure, and cerebral perfusion pressure, any type of pressure in a
human body cavity may be assessed according to the invention described here.
In all cases the invention described here may be used in (a) on-line monitoring of
pressures revealing real-time changes in pressure characteristics, and (b)
assessment of pressure curves after the end of pressure monitoring, that is off-line.
In the assessment of normal pressure hydrocephalus, infusion tests also have been
shown to be of value. During infusion tests pressure is measured within the
cerebrospinal fluid space, either in the lumbar spinal cord or within the cerebral
ventricles. The change in pressure also may be measured simultaneously with
infusion of a liquid such as physiological saline. The present invention allows for
calculation of single waves during the infusion test. The applicant has shown that
changes in the infusion test are most accurately revealed by calculation of single
wave parameters.
When pressures are measured in the cerebrospinal fluid during so-called infusion
testing, a catheter is applied to the cerebrospinal fluid space, usually either within
the cerebral ventricles or to the lumbar cerebrospinal fluid space. The catheter is
connected to a commercially available sensor for sensing pressures within a liquid.
This pressure sensor 16 may be connected via the apparatus 1 described here to a
commercially available computer, or via a vital signs monitor to the computer. In
this situation the apparatus 1 is modified, thus serving as an interface between the
sensor and the computer. Pressure recordings are made while a fluid is infused to
the cerebrospinal fluid space. The applicant has shown that recordings of single
pulse pressure waves may be done simultaneously as the fluid is infused.
According to this intervention the various parameters of the single pulse pressure
waves may be calculated as well as the heart rate variability during infusion of
liquid. Various strategies of assessing single pulse pressure waves may be
performed in this situation. The distribution of single waves during one minute of
recording may be computed and related to the volume change that is known in this
situation. The invention allows for standardisation of numbers or percentages to a
given heart rate and a given recording period. For example, the matrix 53 of single
waves with various amplitudes 51 and latencies 52 may be computed repeatedly
during one minute of recording. Since the infusion rate and hence volume change is
known a curve for each individual may be computed with percentage of pre-
selected single wave on Y axis and volume change on X axis. When the curves of
many individuals are known it is also possible to superimpose the recordings from
one individual against a reference curve from several individuals. It has previously
not been possible to superimpose the intracranial pressure recordings of a single
subject on the pressure volume or elastance curve. The present invention may
provide a technical solution for this problem. Since any types of single pulse wave
parameters may be calculated by this invention, a variety of approaches may be
possible.
With regard to on-line presentations, pressures (for example intracranial and blood
pressures) may be presented by conventional means as real-time presentation of
numerical values of mean pressure or as real-time presentations of intracranial
pressure curves. The present invention provides a technical solution for continuous
analysis and presentation of parameters of single pulse pressure waves. For
example, the numbers or percentages of a certain rise times (for example 10-20
mmHg/sec) during a given recording period (e.g. 1 minutes) may be computed
repeatedly and presented on a graph. Thereby changes in pressures may be detected
before the conventional methods, thus providing early detection/warning of
deterioration of pressures.
Pressure may be monitored in both humans and animals. In particular, the
invention may be used in animal experiments in which blood pressure medications
are assessed.
This invention represents a new technical solution in various aspects, which now
will be commented on:
(a) The invention provides a technical solution for digital recording of pressures in
individuals that are free to move about.
(b) The present apparatus allows for digital storing of a large number of
intracranial and blood pressure recordings, different from the currently available
apparatuses.
(c) The standardisation procedure described here makes it possible to compare
curves of different individuals, though the recording time for each individual may
be different. Without this standardisation procedure, an alternative strategy might
be to select pressure curves of identical duration from different individuals. Then it
would be required to select one part of the curve, however, then it might be
difficult to select a representative part of the curve. For example, if intracranial
pressure or blood pressure is recorded continuously in one individual twice (one
recording of 7 hours and one recording of 9 hours) and the two recordings are
going to be compared, the problem is to compare representative portions of the
curves. The present invention provides a technical solution to this problem by
means of standardising the recordings to a given recording period. Thereby the
whole recording period may be utilised in the assessment.
(d) Though a major use with the present invention is off-line assessment of
pressure recordings, the invention may as well be used for on-line and real-time
monitoring of single pulse pressure waves (blood pressure, intracranial pressure,
cerebral perfusion pressure, or other pressures in a human body cavity). The
invention provides a technical solution for continuous calculation and presentation
of single pulse pressure characteristics. Calculation of the accurate numbers or
percentages of single pulse pressure parameters and comparisons of these
parameters at different times, provide a technical solution for early
detection/warning of changes in pressure. An example is given. The present
invention allows for calculation of the exact numbers or percentages of single pulse
pressure waves with amplitude 6 mmHg and latency 0.23 seconds (rise time 26
mmHg/sec) during one minute or 5 minute recordings. Given that the presence of
60% of such waves during a given recording period represents abnormality, it
would be informative for the physician to have a graphical presentation of repeated
computations of the percentage of this single pulse pressure wave. In fact, the
invention allows for repeated computations of any combinations of single pulse
wave parameters. A continuous and real time computation of the numbers or
percentages of certain rise times (for example 26 mmHg/sec) during a given
recording period represents an alternative presentation. Accordingly, this invention
provides a technical solution for early warning of deterioration of pressures.
(e) The quantitative algorithms and methods of assessing pressures have previously
not been described. Several authors have used methods to explore the frequency
distribution of pressure waves. In particular spectral analysis or Fast Fourier
Transformation (or spectral analysis) has been used. These methods are
fundamentally different from the methods described here. The methods previously
used have not gained ground in the clinic and have not been useful in daily clinical
practice.
(f) The invention provides a technical solution for monitoring intracranial pressure
without the problem of zero drift of pressure sensors or the problem of identifying
the zero level.
(g) The present invention provides a technical solution for comparisons of pressure
curves within a body cavity, that is comparisons of waves in a wide sense of the
word. Examples are comparisons of continuous pressure recordings within a single
subject at different times, such as comparisons during a continuous monitoring of
pressures. Alternatively continuous pressure recordings may be compared at
different times, such as before and after treatment. Pressure curves may be
compared between individuals or continuous pressure curves from an individual
may be compared against a reference material. For example, continuous
intracranial pressure is monitored for 12 hours in a single subject. The numbers of
single pulse pressure waves with pre-selected characteristics concerning latency
and rise time are computed. Since selection of only one portion of the curve would
reduce the accuracy of the recordings, the numbers or percentages of the whole
recording period may be standardised to a selected recording period. For example,
the numbers or percentages of single waves with certain amplitudes and latencies
during the actual recording period of 12 hours may be standardised to numbers of
waves during one hour of recordings. This approach takes away the inaccuracy of
selecting only one portion of the curve. In addition to computing the quantitative
characteristics of high frequency fluctuations in pressure, quantitative analysis of
the low frequency fluctuations in pressure may be computed, providing a more
complete picture of the pressures. For low frequency pressure changes the normal
distribution of pressure elevations of 20 mmHg lasting 10 minutes during for
example one hour of recording may be computed. Due to some individual variation
in the normal distribution exact values may not be computed but rather a
distribution with the median and percentile distribution.
(h) The invention provides a new technical solution for the clinical application of
single wave analysis, when assessing continuous pressure recordings. Single pulse
pressure wave parameters are calculated quantitatively, and the numbers or
percentages of certain single waves may be computed. The numbers/percentages
may be computed during a given recording period. Thereby the invention provides
the unique opportunity to predict the placement of a continuous pressure recording
in one individual on the elastance or pressure-volume curve. It has previously not
been possible to superimpose the pressure recordings of an individual on the
pressure-volume (elastance) curve because this curve is different for different
individuals and the curve may vary over time. The effect of this inter- and intra-
individual variation is markedly reduced by the present intervention. The present
intervention provides a tool for computing a diagram of the normal variation of the
pressure volume curve. For example the exponential pressure volume curve
originally described by Langfitt in 1966 (volume on the X axis and pressure on the
Y axis) may be presented as medians with percentiles. The present invention
provides a tool for computing the distribution of certain single pulse pressure
waves that may be considered as abnormal. For example, given that it is found that
the presence of a single wave with amplitude 6 mmHg and latency 0.23 seconds in
60% of the recording time is abnormal, the invention provides the option to
compute in a single patient the numbers and frequency of such single waves.
During infusion testing pressure changes are known along with changes in volume
because the rate of volume change is known. This situation provides the
opportunity to compute the distribution of the different waves at different levels of
the curve. For example, the distribution of a single wave with a rise time 30
mmHg/seconds may be computed at different pressures and volumes. During a
recording time of 5 minutes these single waves may constitute 20% of single waves
at one point of the horizontal part of the curve but may constitute 80% of single
waves at one point of the vertical portion of the curve. Similar computations may
be made for other single waves. Based on the recordings of many patients,
normograms may a computed. Thereby the results from this single subject may be
superimposed on the normogram of the pressure volume curve and an accurate
description of elastance in this particular subject is given.
While particular embodiments of the present invention have been described herein,
it is to be understood that various changes, modifications, additions and
adaptations are within the scope of the present invention, as set forth in the
following claims.
WE CLAIM :
1.
A method for analysing pressure signals comprising pressure related digital data with a
time reference, derived from pressure measurements on or in a body of a human being
or animal, said method comprising the steps of:
identifying from said digital data features related to single pressure waves in said
pressure signals,
said identifying step including determination of a minimum pressure value related
to diastolic minimum value and a maximum pressure value related to systolic
maximum value, and
determining at least one parameter of the single wave parameters elected from the
group of: pressure amplitude = ?P = [(maximum pressure value) - (minimum
pressure value)], latency (?T), rise time or rise time coefficient = ?P/?T, and
wavelength of the single wave, and
comprising the further step of:
determining numbers of said single pressure waves occurring during a given time
sequence,
wherein said determining of numbers includes:
determining numbers of single pressure waves with pre-selected values of one or
more of said single pressure wave parameters during said given time sequence, and
further includes determining numbers of single pressure waves with pre-selected
combinations of two or more of said single pressure wave parameters during said
given time sequence.
2.
A method as claimed in claim 1, wherein the latency ?T is defined as the time
elapsed from occurrence of the minimum pressure value to the maximum pressure
value.
3.
A method as claimed in claim 1 or 2, wherein the amplitude ?P is defined as the
pressure difference between the systolic maximum pressure and the diastolic
minimum pressure during a series of increasing pressures of single pressure wave.
4.
A method as claimed in claim 1, wherein said maximum pressure value is one of
three peak values occurring in said single pressure wave.
5.
A method as claimed in claim 4, wherein
a first (P1) of said three peak values in said single pressure wave has an
amplitude ?P1 representing relative pressure difference between systolic
maximum pressure and diastolic minimum pressure,
a second (P2) of said three peak values has an amplitude ?P2 related to a tidal
wave portion of said single pressure wave, and
a third (P3)of said three peak values has an amplitude AP3 related a dichrotic
wave portion of said single pressure wave.
6.
A method as claimed in claim 3, 4 or 5, comprising calculation of one or more
rise time coefficients between said amplitude and latency values.
7.
A method as claimed in anyone of claims 1 -6, wherein in said single pressure wave
said amplitude and latency values are relative values only, respectively.
8.
A method as claimed in anyone of claims 1-6, wherein said single pressure wave
amplitudes and latency values are relative values not related to a zero pressure level.'
9.
A method as claimed in anyone of claims 1 - 8, wherein numbers of single pressure
waves during a said time sequence corresponds to the heart rate during said time
sequence of said human being or animal.
10.
A method as claimed in anyone of claims 1-9, comprising in said determining step
defining related limits within which at least one of said parameters, i.e. amplitude,
latency, rise time coefficient, and heart rate are expected to lie.
11.
A method as claimed in claim 10, said determining step further comprising rejecting a
value of a specific one of said parameters not lying within related, given threshold
values.
12.
A method as claimed in claim 10 or 11, wherein rejection of an amplitude related
parameter value involves rejection of related false minimum pressure and false
maximum pressure values.
13.
A method as claimed in claim 10 and 11, wherein calculated values of AP/AT outside
given threshold values are rejected.
14.
A method as claimed in anyone of claims 1-4, wherein any determined value of AP
ess than the threshold value is discarded.
15.
A method as claimed in anyone of claims 1-8, wherein a matrix is created based on
determination of numbers of single pressure waves with preselected, values of one or
more parameters related thereto during a given recording sequence, said parameters
elected from pressure amplitude ?P, latency ?T , and rise time coefficient ?P/?T.
16.
A method as claimed in claim 15, wherein one axis of the matrix is related to an array
of pre-selected values of pressure amplitude (?P), and wherein the other axis is
related to an array of pre-selected values of latency (?T).
17. .
A method as-claimed in claim 15 or 16, wherein numbers in said matrix relate to
numbers of occurrence of matches between specific pressure amplitude (?P) and
specific latency (?T) values, related to successive measurements of single pressure
waves over a specific measurement period.
18.
A method as claimed in claim 17, wherein the occurrence of matches is indicated
through actual number or standardisation based number of matches during the specific
measurement period.
19.
A method as claimed in claim 17, wherein the occurrence of matches is indicated
through percentage of matches during the specific measurement period.
20.
A method as claimed in claim 18, wherein said standardisation of said numbers or
percentages of occurrence of matches is a function of the length of the specific
measurement period.
21.
A method as claimed in claim 18 or 20, wherein said standardisation is related to
single pressure wave wavelength (heart rate).
22.
A method as claimed in claim 20 or 21, wherein said standardisation is expressed
through use of ratio numbers or percentages.
23.
A method as claimed in anyone of claims 15-22, wherein the matrix undergoes
statistical analysis for subsequent graphical presentation.
24.
A method as claimed in anyone of claims 15 - 22, wherein reiterated updating of
occurrence of matches in matrix form is made, e.g. every five seconds or every one
minute, during ongoing measurements taken over said specific measurement period.
25.
A method as claimed in anyone of claims 1- 24, wherein data related to single
pressure waves obtained from measurements of a) arterial blood pressure and b)
elected other internal body pressure, e.g. intra-cavity pressure are compared within
identical time reference.
26.
A method as claimed in claim 25, wherein numbers of single pressure waves from
different pressures are compared within said identical time reference.
27.
A method as claimed in claim 25 or 26, wherein standardised numbers or percentages
of single pulse pressure waves from different pressures are compared within said
identical time reference.
28.
A method as claimed in anyone of claims 25 - 27, wherein said comparisons are
related to number of relationships between rise time coefficient of intra-cavity
pressure waves, e.g. intra-cranial pressure waves, and blood pressure waves.
29.
A method as claimed in anyone of claims 25 - 28, wherein said comparisons are made
between matrixes for the different pressure waves.
30.
A method as claimed in claim 25 or 29, wherein relative duration of each single
pressure wave corresponds to heart rate, and wherein a heart rate parameter is
indicative of abnormality of intercranial pressure.
31.
A method as claimed in anyone of claims 25 - 30, wherein said internal body .
pressure is one or more of intra-cranial pressure, blood pressure, cerebrospinal fluid
pressure and cerebral perfusion pressure.
32.
A method as claimed in anyone of claims 1- 31, wherein the data from measurements
of single pressure waves are compared against data derived from a continuous or
interval-based measurement of absolute pressures made over a same total
measurement period, said absolute pressures being relative to atmospheric pressure.
33.
A method as claimed in anyone of claims 15 - 32, wherein said matrix is based on
updating occurrences of matches at regular intervals.
34.
A method for analysing pressure signals comprising pressure related digital data with a
time reference, derived from pressure measurements on or in a body of a human being
or animal, said method comprising the steps of:
- identifying from said digital data features related to absolute pressures relative to
atmospheric pressure,
recording repeatedly at specific time intervals, intermittently, in any reiterated
manner, or continuously absolute pressure data to create a pressure trend plot
against time,
determining from said recording a number of different pressure levels and
duration thereof, and
presenting the numbers of levels of various time durations in said matrix format.
35.
A method as claimed in claim 34, wherein said numbers in said matrix relate to
number of occurrence of matches between a specific absolute pressure level and a
specific level time duration.
36.
A method as claimed in claim 34 or 35, wherein the occurrence of matches is
indicated through actual number or standardisation based number of matches during a
specific measurement period.
37.
A method as claimed in claim 34 or 35, wherein the occurrence of matches is
indicated through percentage of matches during a specific measurement period.
38.
A method as claimed in claim 36, wherein said standardisation of said numbers or
percentages of occurrence of matches is a function of the length of the specific
measurement period.
39.
A method as claimed in claim 38, wherein said standardisation is expressed through
use of ratio numbers or percentages.
40.
A method as claimed in anyone of claims 34 - 39, wherein reiterated plotting or
updating of occurrence of matches in matrix form is made during measurements
taken over a specific measurement period.
41.
A method as claimed in anyone of claims 34 - 40, wherein said matrix of absolute
pressure levels and durations thereof is compared with another matrix based on
measurements of single pressure waves and one or more parameters related thereto,
extending over a specific measurement period.
42.
A method as claimed in claim 41, wherein said single pressure waves are derived from
arterial blood pressure waves and/or intra-cavity pressure waves.
43.
A method as claimed in claim 42, wherein said intra-cavity pressure is one or more of
infra-cranial pressure, blood pressure, cerebrospinal fluid pressure and cerebral
perfusion pressure.
The present invention relates to a system and method for digital sampling, quantitative analysis and presentation of
pressures in a body cavity. The invention also relates to a portable apparatus for monitoring, sampling and storing pressure and a
software for analysis of pressures. The invention includes an algorithm for analysis and presentations of pressures and a software for
performing the analysis. The computer software may be integrated in the portable apparatus and in a variety of systems. The software
provides different quantitative presentations of pressure curves as a matrix of numbers of intracranial pressure elevations of different
levels and durations and a matrix of numbers of single pulse pressure waves with preselected characteristics. The parameters may
be standardised according to recording time and heart rate variablity. The data may be presented indifferent ways, both on-line and
off-line after pressure monitoring.

Documents:

1297-KOLNP-2003-CORRESPONDENCE.pdf

1297-KOLNP-2003-FORM 27.pdf

1297-KOLNP-2003-FORM-27.pdf

1297-kolnp-2003-granted-abstract.pdf

1297-kolnp-2003-granted-assignment.pdf

1297-kolnp-2003-granted-claims.pdf

1297-kolnp-2003-granted-correspondence.pdf

1297-kolnp-2003-granted-description (complete).pdf

1297-kolnp-2003-granted-drawings.pdf

1297-kolnp-2003-granted-examination report.pdf

1297-kolnp-2003-granted-form 1.pdf

1297-kolnp-2003-granted-form 18.pdf

1297-kolnp-2003-granted-form 3.pdf

1297-kolnp-2003-granted-form 5.pdf

1297-kolnp-2003-granted-gpa.pdf

1297-kolnp-2003-granted-others.pdf

1297-kolnp-2003-granted-reply to examination report.pdf

1297-kolnp-2003-granted-specification.pdf


Patent Number 227663
Indian Patent Application Number 1297/KOLNP/2003
PG Journal Number 03/2009
Publication Date 16-Jan-2009
Grant Date 14-Jan-2009
Date of Filing 13-Oct-2003
Name of Patentee SENSOMETRICS AS
Applicant Address STJERNEVEIEN 3D, N-0779 OSLO
Inventors:
# Inventor's Name Inventor's Address
1 EIDE PER KRISTIAN STJERNEVEIEN 3D, N-0779 OSLO
PCT International Classification Number A61B 5/03
PCT International Application Number PCT/NO2002/00164
PCT International Filing date 2002-04-29
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 09/843,702 2001-04-30 U.S.A.