U.S. patent application number 10/908625 was filed with the patent office on 2005-09-15 for methods of organ vitality assessment.
Invention is credited to SINGER, MICHAEAL G..
Application Number | 20050203433 10/908625 |
Document ID | / |
Family ID | 37000079 |
Filed Date | 2005-09-15 |
United States Patent
Application |
20050203433 |
Kind Code |
A1 |
SINGER, MICHAEAL G. |
September 15, 2005 |
METHODS OF ORGAN VITALITY ASSESSMENT
Abstract
A method of organ vitality assessment using bioelectric
impedance analysis in a biological model for body composition
analysis, and using the results to provide an objective assessment
of volume and distribution of tissues, as well as electrical health
of cells and membranes of an organ.
Inventors: |
SINGER, MICHAEAL G.;
(HARRISVILLE, MI) |
Correspondence
Address: |
IRVING M. WEINER
635 N. US-23
P.O. BOX 186
HARRISVILLE
MI
48740
|
Family ID: |
37000079 |
Appl. No.: |
10/908625 |
Filed: |
May 19, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10908625 |
May 19, 2005 |
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10701004 |
Nov 4, 2003 |
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60424828 |
Nov 8, 2002 |
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Current U.S.
Class: |
600/547 |
Current CPC
Class: |
A61B 5/416 20130101;
A61B 5/0537 20130101; A61B 5/4869 20130101; A61B 5/053 20130101;
G01N 33/48707 20130101 |
Class at
Publication: |
600/547 |
International
Class: |
A61B 005/05 |
Claims
What is claimed is:
1. A method of organ vitality assessment, comprising the steps of:
utilizing bioelectric impedance analysis in a biological model for
body composition analysis; and using the results of said utilizing
step to provide an objective assessment of volume and distribution
of fluid and tissues, as well as electrical health of cells and
membranes of said organ.
2. The method according to claim 1, including the step of:
utilizing a modified bioelectric impedance analysis for body
composition analysis to assess the health of cells of said organ by
the measured reactance thereof.
3. A method according to claim 1, including the steps of: placing
signal introduction electrodes on opposite lateral peripheral
borders of said organ; placing signal detection electrodes at
superior and inferior borders of said organ for a first part of an
initial measurement of said organ; measuring and recording first
values of resistance and reactance, and calculating the phase angle
of said organ in said initial measurement; then placing said signal
introduction electrodes on said superior and said inferior borders
of said organ; placing said signal detection electrodes on said
opposite lateral borders of said organ; measuring and recording
second values of said resistance and said reactance, and
calculating the phase angle of said organ; and comparing said first
and second values to normal values to assess vitality of said
organ.
4. A method according to claim 2, including the steps of: placing
signal introduction electrodes on opposite lateral peripheral
borders of said organ; placing signal detection electrodes at
superior and inferior borders of said organ for a first part of an
initial measurement of said organ; measuring and recording first
values of resistance and reactance, and calculating the phase angle
of said organ in said initial measurement; then placing said signal
introduction electrodes on said superior and said inferior borders
of said organ; placing said signal detection electrodes on said
opposite lateral borders of said organ; measuring and recording
second values of said resistance and said reactance, and
calculating the phase angle of said organ; and comparing said first
and second values to normal values to assess vitality of said
organ.
5. A method according to claim 3, including the following
additional steps: again placing said signal introduction electrodes
on said opposite lateral peripheral borders of said organ; again
placing said signal detection electrodes at said superior and said
inferior borders of said organ; measuring and recording third
values of resistance and reactance, and calculating the phase angle
of said organ; then again placing said signal introduction
electrodes on said superior and said inferior borders of said
organ; again placing said signal detection electrodes on said
opposite lateral borders of said organ; measuring and recording
fourth values of said resistance and said reactance of said organ;
and comparing said first and second values to said third and fourth
values to determine if the values are within a predetermined
acceptable range of agreement denoting no further loss of said
organ vitality.
6. A method according to claim 4, including the following
additional steps: again placing said signal introduction electrodes
on said opposite lateral peripheral borders of said organ; again
placing said signal detection electrodes at said superior and said
inferior borders of said organ; measuring and recording third
values of resistance and reactance, and calculating the phase angle
of said organ; then again placing said signal introduction
electrodes on said superior and said inferior borders of said
organ; again placing said signal detection electrodes on said
opposite lateral borders of said organ; measuring and recording
fourth values of said resistance and said reactance, and
calculating the phase angle of said organ; and comparing said first
and second values to said third and fourth values to determine if
the values are within a predetermined acceptable range of agreement
denoting no further loss of said organ vitality.
7. A method according to claim 1, including the steps of: upon
harvesting said organ from a donor, placing signal introduction
electrodes on opposite lateral peripheral borders of said organ;
placing signal detection electrodes at superior and inferior
borders of said organ for a first part of an initial measurement of
said organ; measuring and recording first values of resistance and
reactance, and calculating the phase angle of said organ in said
initial measurement; then placing said signal introduction
electrodes on said superior and said inferior borders of said
organ; placing said signal detection electrodes on said opposite
lateral borders of said organ; measuring and recording second
values of said resistance and said reactance, and calculating the
phase angle of said organ; and comparing said first and second
values to normal values to assess vitality of said organ.
8. A method according to claim 2, including the steps of: upon
harvesting said organ from a donor, placing signal introduction
electrodes on opposite lateral peripheral borders of said organ;
placing signal detection electrodes at superior and inferior
borders of said organ for a first part of an initial measurement of
said organ; measuring and recording first values of resistance and
reactance, and calculating the phase angle of said organ in said
initial measurement; then placing said signal introduction
electrodes on said superior and said inferior borders of said
organ; placing said signal detection electrodes on said opposite
lateral borders of said organ; measuring and recording second
values of said resistance and said reactance, and calculating the
phase angle of said organ; and comparing said first and second
values to normal values to assess vitality of said organ.
9. A method according to claim 7, including the steps of: upon
arrival of said organ at the location of a recipient, placing
signal detection electrodes at superior and inferior borders of
said organ for a first part of an initial measurement of said
organ; measuring and recording first values of resistance and
reactance, and calculating the phase angle of said organ in said
initial measurement; then placing said signal introduction
electrodes on said superior and said inferior borders of said
organ; placing said signal detection electrodes on said opposite
lateral borders of said organ; measuring and recording second
values of said resistance and said reactance, and calculating the
phase angle of said organ; and comparing said first and second
values to normal values to assess vitality of said organ.
10. A method according to claim 8, including the steps of: upon
arrival of said organ at the location of a recipient, placing
signal detection electrodes at superior and inferior borders of
said organ for a first part of an initial measurement of said
organ; measuring and recording first values of resistance and
reactance, and calculating the phase angle of said organ in said
initial measurement; then placing said signal introduction
electrodes on said superior and said inferior borders of said
organ; placing said signal detection electrodes on said opposite
lateral borders of said organ; measuring and recording second
values of said resistance and said reactance, and calculating the
phase angle of said organ; and comparing said first and second
values to normal values to assess vitality of said organ.
11. A method according to claim 9, including the steps of: prior to
the implantation of said organ into said recipient, again placing
said signal detection electrodes at said superior and said inferior
borders of said organ; measuring and recording third values of
resistance and reactance, and calculating the phase angle of said
organ; then again placing said signal introduction electrodes on
said superior and said inferior borders of said organ; again
placing said signal detection electrodes on said opposite lateral
borders of said organ; measuring and recording fourth values of
said resistance and said reactance of said organ; and comparing
said first and second values to said third and fourth values to
determine if the values are within a predetermined acceptable range
of agreement denoting no further loss of said organ vitality.
12. A method according to claim 10, including the steps of: prior
to the implantation of said organ into said recipient, again
placing said signal detection electrodes at said superior and said
inferior borders of said organ; measuring and recording third
values of resistance and reactance, and calculating the phase angle
of said organ; then again placing said signal introduction
electrodes on said superior and said inferior borders of said
organ; again placing said signal detection electrodes on said
opposite lateral borders of said organ; measuring and recording
fourth values of said resistance and said reactance of said organ;
and comparing said first and second values to said third and fourth
values to determine if the values are within a predetermined
acceptable range of agreement denoting no further loss of said
organ vitality.
13. A method of organ vitality assessment, comprising the steps of:
placing signal introduction electrodes on opposite lateral
peripheral borders of said organ; placing signal detection
electrodes at superior and inferior borders of said organ for a
first part of an initial measurement of said organ; measuring and
recording first values of resistance and reactance of said organ in
said initial measurement; then placing said signal introduction
electrodes on said superior and said inferior borders of said
organ; placing said signal detection electrodes on said opposite
lateral borders of said organ; measuring and recording second
values of said resistance and said reactance of said organ; and
comparing said first and second values to normal values to assess
vitality of said organ.
14. A method according to claim 13, including the following
additional steps: again placing said signal introduction electrodes
on said opposite lateral peripheral borders of said organ; again
placing said signal detection electrodes at said superior and said
inferior borders of said organ; measuring and recording third
values of resistance and reactance, and calculating the phase angle
of said organ; then again placing said signal introduction
electrodes on said superior and said inferior borders of said
organ; again placing said signal detection electrodes on said
opposite lateral borders of said organ; measuring and recording
fourth values of said resistance and said reactance, and
calculating the phase angle of said organ; and comparing said first
and second values to said third and fourth values to determine if
the values are within a predetermined acceptable range of agreement
denoting no further loss of said organ vitality.
15. A method of organ vitality assessment for transplantation of an
organ being assessed, comprising the steps of: placing signal
introduction electrodes on opposite lateral peripheral borders of
said organ upon harvesting of said organ; placing signal detection
electrodes at superior and inferior borders of said organ for a
first part of an initial measurement upon said harvesting of said
organ; measuring and recording first values of resistance and
reactance of said organ in said initial measurement; then placing
said signal introduction electrodes on said superior and said
inferior borders of said organ; placing said signal detection
electrodes on said opposite lateral borders of said organ;
measuring and recording second values of said resistance and said
reactance of said organ; and comparing said first and second values
to normal values to determine if said organ is acceptable or not
for said transplantation.
16. A method according to claim 15, wherein: if said organ is
acceptable, then prior to implanting said organ, performing the
following steps; again placing said signal introduction electrodes
on said opposite lateral peripheral borders of said organ; again
placing said signal detection electrodes at said superior and said
inferior borders of said organ for a first part of an initial
post-harvest/pre-implant measurement; measuring and recording third
values of resistance and reactance of said organ in said initial
post-harvest/pre-implant measurement; then placing said signal
introduction electrodes on said superior and said inferior borders
of said organ; placing said signal detection electrodes on said
opposite lateral borders of said organ; measuring and recording
fourth values of said resistance and said reactance of said organ;
and comparing said first and second values to said third and fourth
values to determine if the values are within a predetermined
acceptable range of agreement denoting no further loss of said
organ vitality.
17. A method according to claim 15, wherein: once said organ is
transplanted into a recipient, follow-up measurements of whole-body
and regional resistance and reactance and the calculation of phase
angle specific to a site of transplant of said organs, will be made
with electrodes placed for a whole-body measurement (wrist and
ankle) and with the detection electrodes superior and inferior, as
well as medial lateral to the organ site.
18. A method according to claim 16, wherein: once said organ is
transplanted into a recipient, follow-up measurements of whole-body
and regional resistance and reactance and the calculation of phase
angle specific to a site of transplant of said organs, will be made
with electrodes placed for a whole-body measurement (wrist and
ankle) and with the detection electrodes superior and inferior, as
well as medial lateral to the organ site.
19. A method according to claim 15, including: harvesting said
organ from a first species of biological entity; and implanting
said organ in a different species of biological entity.
20. A method according to claim 16, including: harvesting said
organ from a first species of biological entity; and implanting
said organ in a different species of biological entity.
Description
[0001] The present application is a divisional application of U.S.
patent application Ser. 10/701,004 filed Nov. 4, 2003, which is
based on and claims priority from U.S. Provisional Patent
Application Ser. No. 60/424,828 filed Nov. 8, 2002, which in turn
is a continuation-in-part of U.S. Pat. No. 6,587,715. The complete
disclosure of the aforesaid applications and patent are
incorporated herein by reference hereto.
[0002] The present invention relates to the method which
incorporates the utilization of bioelectrical impedance analysis
(BIA) in a biological model for body composition analysis (BCA) to
provide an objective assessment of an organ's and/or biological
entity's volume and distribution of fluids and tissue as well as
the electrical health of cells and membranes.
[0003] Another aspect of the present invention relates to a method
of organ vitality assessment for various purposes, including
transplantation of said organ being assessed.
[0004] The terms "biological entity", "patient" and "subject" as
used herein mean: "any and all human beings, animals and/or living
organisms."
[0005] The term "non-acute death" as used herein means: "any death
that does not occur acutely; it occurs more than four days (96
hours) from a precipitous event or illness; it is the end-point of
a process whose duration exceeds the four-day reference; unlike
that death resulting from a proximate, immediate or acute event, a
`non-acute death` occurs over time."
BACKGROUND OF THE INVENTION
[0006] The prior, but not necessarily relevant, art is exemplified
by:
[0007] Bagno U.S. Pat. No. 2,111,135; Hanson U.S. Pat. No.
2,852,739; Tolles U.S. Pat. No. 3,085,566; Thomasset U.S. Pat. No.
3,316,896; Max et al. U.S. Pat. No. 3,498,288; Sigworth U.S. Pat.
No. 3,882,851; Ghislaine et al. U.S. Pat. No. 4,823,804; Gallup et
al. U.S. Pat. No. 5,372,141; Kotler U.S. Pat. No. 5,615,689;
Brasile U.S. Pat. No. 6,024,698; Cherepenin et al. U.S. Pat. No.
6,236,866; and Kobayashi U.S. Patent Application Publication
2001/0023362.
[0008] A desideratum of the present invention is to avoid the
animadversions of conventional methods and techniques, and to
provide a novel method of organ vitality assessment for
transplantation and/or xenotransplantation and for other purposes
of said organ being assessed.
SUMMARY OF THE INVENTION
[0009] The present invention provides a method of organ vitality
assessment, comprising the steps of: utilizing bioelectric
impedance analysis in a biological model for body composition
analysis; and using the results of said utilizing step to provide
an objective assessment of volume and distribution of fluid and
tissues, as well as electrical health of cells and membranes of
said organ.
[0010] The present invention also provides a method of organ
vitality assessment, comprising the steps of: placing signal
introduction electrodes on opposite lateral peripheral borders of
said organ; placing signal detection electrodes at superior and
inferior borders of said organ for a first part of an initial
measurement of said organ; measuring and recording first values of
resistance and reactance of said organ in said initial measurement;
then placing said signal introduction electrodes on said superior
and said inferior borders of said organ; placing said signal
detection electrodes on said opposite lateral borders of said
organ; measuring and recording second values of said resistance and
said reactance of said organ; and comparing said first and second
values to normal values to assess vitality of said organ.
[0011] The present invention further provides a method of organ
vitality assessment for transplantation of said organ being
assessed, comprising the steps of: placing signal introduction
electrodes on opposite lateral peripheral borders of said organ
upon harvesting of said organ; placing signal detection electrodes
at superior and inferior borders of said organ for a first part of
an initial measurement upon said harvesting of said organ;
measuring and recording first values of resistance and reactance of
said organ in said initial measurement; then placing said signal
introduction electrodes on said superior and said inferior borders
of said organ; placing said signal detection electrodes on said
opposite lateral borders of said organ; measuring and recording
second values of said resistance and said reactance of said organ;
and comparing said first and second values to normal values to
determine if said organ is acceptable or not for said
transplantation.
[0012] The present invention possesses many advantages and features
which will become more apparent to those persons skilled in this
particular area of technology and to other persons after having
read the detailed description of the present invention as set forth
hereinbelow in conjunction with the accompanying patent
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a schematic illustration of one embodiment of the
present invention.
[0014] FIG. 2 illustrates how electrodes may be placed on a hand
for the BIA testing procedure.
[0015] FIG. 3 illustrates how the electrodes may be placed on the
foot for the BIA testing.
DETAILED DESCRIPTION OF THE INVENTION
[0016] BIA is an electrodiagnostic methodology based upon the
conductive properties of the body's tissues, cells, and fluids. The
BIA instrument, such as that disclosed in U.S. Pat. No. 5,372,141,
an impedance plethysmograph, may use a constant current source
producing a low-voltage electrical signal, usually 800 micro-amps
at a high frequency, often fixed at 50 KHz, to set up an electrical
field in the whole body or a body segment using a pair of surface
ECG-type electrodes.
[0017] The methods of the present invention can utilize a
modification of the body composition analyzer disclosed in U.S.
Pat. No. 5,372,141, the entire contents of which are incorporated
herein by reference thereto.
[0018] In accordance with the present invention, utilization of BIA
in a biological model for BCA provides an objective assessment of
the study subject's (whole body or organ) volume and distribution
of fluids and tissues, as well as the electrical health of the
cells and membranes.
[0019] The characteristics of BIA include precision, accuracy,
feasibility and economy. BIA may be applied to any area of
interest, regionally or to the whole body. It is non-offensive,
causing no harm. It may be repeated freely, as desired, to
illustrate change over time so that progression of conditions can
be monitored and intervention modified.
[0020] One aspect of the present invention applies the BIA
technology for BCA assessment of vitality of organs for transplant,
vitality of organs from other species for human transplantation
(xenotransplantation), and to monitor and assess the timing of
death.
[0021] Organ vitality assessment is based upon the ability of a
modified BIA for BCA to illustrate the health of cells by the
measured reactance (X).
[0022] Upon organ harvest, signal introduction electrodes are
placed on the opposite lateral peripheral borders of the organ
being assessed, and signal detection electrodes are placed at the
superior and inferior borders of the organ being assessed for the
first part of the initial The values of electrical resistance (R)
and impedance (X) are measured and recorded.
[0023] The signal introduction electrodes are then re-positioned or
placed on the superior and inferior borders of the organ being
assessed, while the signal detection electrodes are now
re-positioned or placed the opposite lateral peripheral borders of
the organ being assessed.
[0024] Further values of R and X are measured and recorded.
[0025] The values are then compared to normal values, and the organ
is determined to be acceptable or not.
[0026] If acceptable, prior to organ implant (transplantation or
xenotransplantation), the sequence of steps described hereinabove
is repeated with comparison being made to the electrical values
which were measured and recorded upon organ harvest.
[0027] The values should be within an acceptable range of agreement
denoting no further loss of organ vitality, and then the
implantation is completed.
[0028] In accordance with the present invention, the same scenario
is utilized for organs from different species.
[0029] For determination of the timing of death, whole body
measurements are made at predetermined intervals of time
(preferably, but not necessarily, every other day) with electrical
resistance (R), reactance (X), and phase angle (f) being measured
and recorded. Initial values are compared to normal values and to
those serially measured and recorded.
[0030] The uncorrectable loss of cell mass and membrane capacity,
as evidenced by a reduction in X and f or by an uncorrectable and
increasing disparity of ECW (extracellular water) volume being
greater than ICW (intracellular water) volume and remaining
uncorrectable, are the hallmarks of the progression to the death of
the biological entity.
[0031] f values less than four degrees denote serious illness.
[0032] f values less than two degrees denote imminent demise.
[0033] One embodiment of the present invention provides a method
for determining illness of a biological entity, progression to
death of said biological entity, and/or timing of death of said
biological entity, comprising the steps of: taking whole body
measurements of resistance, reactance, phase angle, extracellular
water volume, and intracellular water volume at predetermined
intervals of time; recording said whole body measurements;
comparing initial values of said whole body measurements to normal
values of said whole body measurements and to serially measured
values of said whole body measurements; and determining from said
comparison step hallmarks of said illness of said biological
entity, said progression to said death of said biological entity,
and/or said death of said biological entity.
[0034] Another embodiment of the present invention provides a
method of organ vitality assessment for transplantation of said
organ being assessed, comprising the steps of: placing signal
introduction electrodes on opposite lateral peripheral borders of
said organ upon harvesting of said organ; placing signal detection
electrodes at superior and inferior borders of said organ for a
first part of an initial measurement upon said harvesting of said
organ; measuring and recording first values of resistance and
reactance of said organ in said initial measurement; then placing
said signal introduction electrodes on said superior and said
inferior borders of said organ; placing said signal detection
electrodes on said opposite lateral borders of said organ;
measuring and recording second values of said resistance and said
reactance of said organ; and comparing said first and second values
to normal values to determine if said organ is acceptable or not
for said transplantation.
[0035] There will now be described a preferred embodiment of the
present invention. The preferred embodiment provides a method and
apparatus for use in detecting the presence and severity of
illness, the effectiveness of treatment interventions, and the
ability to change treatment to be more effective or aggressive; to
optimize outcome, limit morbidity and mortality and illustrate the
patient's prognosis.
[0036] The purpose of the preferred embodiment is to empower the
healthcare provider and the patient by detecting and characterizing
the presence and nature of illness and injury to include episodic,
serious, and non-episodic illness and injury, its progression, and
the effectiveness of treatment interventions and the prognosis of
the patient.
[0037] There is provided a method and system for use in detecting
the presence and severity of illness in diagnosing and treating a
patient to optimize the treatment intervention and determine the
prognosis of the patient.
[0038] This system employs the use of Whole Body Impedance Analysis
to measure the patient's Resistance, Reactance, Phase Angle, and
related electrical values at a healthy baseline, and thereafter in
relation to the patient's complaints to evaluate the temporal or
progressive nature of negative values or diminution of the measured
values over time.
[0039] Specifically, the system identifies the patient's healthy
baseline measured electrical values and, during routine health
examinations or when the patient complains of any symptoms or
experiences any signs of illness or injury, illustrates excursion
from the baseline values that may exceed a thirty-day time frame or
progressively diminish. Episodic illness and recoverable injury is
characterized by a brief, less than thirty days, excursion below
the baseline values and return to the baseline values. More severe
illness and injury are characterized by progressive or rapid
diminution of the measured values.
[0040] Once an effective treatment intervention is begun, the
measured values will stabilize and then return to the baseline
values indicative of the patient's positive prognosis. More
effective treatment is indicated by a more rapid return to
baseline-measured values. If the values do not improve, a modified
or more aggressive treatment intervention is indicated whose
positive effectiveness will be indicated by the initial
stabilization of the measured values and their subsequent return to
baseline values. Prognosis is proportional to the speed and
direction of the return of the measured value to or from the
baseline values. A positive prognosis is indicated by a progressive
and/or rapid return to the measure baseline values. A negative
prognosis is indicated by a progressive and/or rapid diminution of
the measured values. The speed of loss or gain of the measured
values is proportional to the return of health or the severity of
the illness or injury. A neutral or stabilized measured value lower
than the healthy baseline, over an extended period of time, greater
than six months, indicates a new baseline, a less healthy condition
and pre-disposition to future illness.
[0041] Frequency of measurements is in proportion to the severity
of the process to be illustrated; more severe illness or injury,
characterized by more severe symptoms, signs and negative
laboratory findings and progressive and/or rapid diminution of the
measured values, require more frequent measurements, daily and
every other day. Less severe illnesses and injuries may be
illustrated with weekly measurements.
[0042] The invention will now be further explained with reference
to FIGS. 1-3.
[0043] The primary study method for an impedance plethsymographic
examination either Whole-Body 1 or Regional 2 is simple and
straightforward. The patient requires no advanced preparation for
the study. However, the patient should not be diaphoretic, soaked
in urine or any other surface liquid that would provide an
alternative pathway for the conduction of the electrical signal
that is the basis of the study.
[0044] The patient is counseled to lie quietly, motionless, and
informed that the test will take less than five minutes if the
patent is cooperative. The patient is generally placed in a supine
position with arms and legs abducted about thirty degrees from the
midline on a dry non-conductive surface. Whole Body 1 and Regional
2 studies require a tetrapolar electrode scheme in which placement
of four (two pairs) surface, ECG electrodes in strict relation to
anatomical landmarks at the wrist and ankle. If the patient's skin
is either too dry or too oily, wiping the electrode placement area
with an alcohol prep wipe is suggested. The right side of the body
is generally used with the electrodes placed ipsilaterally. However
if the patient's condition requires contra-lateral placement and
alternative body positions, they can be utilized with the
understanding and proviso that the same position will be repeated
with all future measurements. The signal detection (SD) electrodes
3 or 4 must be placed with the greatest precision in relation to
known anatomical landmarks on both the wrist and the ankle.
[0045] On the wrist, the superior linear border of the electrode,
its top straight line, must equally bisect the ulnar stylus, bone
prominence (bump) on the little finger side of the wrist with the
tab of the electrode facing away from the body of the patient. The
signal introduction (SI) electrodes 5 are placed distal from the SD
electrodes 3 and must be kept at a minimum distance that equals or
exceeds that of the diameter of the segment being measured (e.g.,
the wrist). This is most easily and efficiently accomplished by
using the distal phalanx of the middle finger, just proximal to the
nail.
[0046] On the ankle, the SD electrode 4 is placed so that the
superior linear border equally bisects the medial malleolous (the
bump on the big toe side of the ankle) with the tab facing outwards
from the patient. Care should be exercised to use the medical
malleolous because the lateral malleolous (the bump on the little
toe side of the ankle) is inferior or below the medial malleolous
landmark. The SI electrode 6 is placed on the big toe, as shown in
FIG. 1.
[0047] The plethysmograph is connected via patient cable leads with
strict attention paid to SI and SD leads connected to SI and SD
electrodes. The device is energized and the values of resistance
and reactance in ohms, are measured individually, allowing a moment
(ten to fifteen seconds) to settle, and then are recorded. The
electrodes are carefully removed so as not to injure friable skin
or contaminate the examiner.
[0048] Any standard impedance plethysmograph that utilizes a
500-800 micro-amp constant current electrical source at
50-kilohertz frequency can be utilized. Preferably, but not
necessarily, an RJL Systems, Inc. manufactured Quantum II
instrument system may be used for both Whole Body 1 and Regional 2
measurements.
[0049] For Regional 2 measurements, the patient is prepared in the
same manner as with a Whole-Body 1 examination. For Regional 2
measurements of the chest, abdomen or extremities (arms/legs,
left-right, upper or lower), the signal detection electrodes 7 are
placed superiorly and inferiorly in precise relation to the area of
interest. The distance between the detection electrodes is
precisely measured and recorded in centimeters. The skin is marked
with a surgical pen to assure accurate and reproducible electrode
placement for serial measurements. The SI electrodes 1 are best
placed in the standard Whole-Body locations, however this requires
a specialized patient cable with adequate distance or throw, about
eighteen inches of length allowed, between the insertion point into
the patient cable to and from the clip ends. The impedance
plethysmograph is connected via the patient cables with strict
adherence to the SD lead to the SD electrode and the SI lead to the
SI electrode. The measured values are recorded and the electrodes
carefully removed.
[0050] The measured values, resistance, reactance and phase angle
are recorded, archived and graphically presented to illustrate
change over time and illuminate the processes of disease
progression and response to treatment. The frequency of serial
measurements is proportional to the dynamic of the event to be
captured. If at all possible, a baseline study value is
particularly desirable.
[0051] Disorders characterized by dynamic shifts of extracellular
fluid volumes require more frequent measurements, often prior to
and after a procedure or treatment such as a patient requiring
hemodialysis, aggressive diuresis in organ failure or repletion of
fluids in acute dehydration or trauma. The measured resistance
value in ohms is inversely proportional to the extracellular fluid
volume of the patient. When resistance ohms decrease fluid has
increased and conversely when resistance ohms increase fluid volume
has decreased. So, once an initial ohm measurement value is
established by baseline or first study, subsequent measurements
illustrate the patient's course and response to disease progression
and the effectiveness of the selected treatment intervention. The
severity of the disease or insult condition evidenced by the speed
of the excursion from baseline or initial measurement value. Fluid
changes that move more than fifty ohms in a twenty-four hour period
are severe and indicate a more acute and serious condition than
those that move fifty ohms in a week's time indicative of a more
chronic condition. Both conditions require intervention, however as
chronic insidious changes are as adverse to survival as more rapid
changes.
[0052] These changes may be evidenced in both Whole Body 1 and
Regional 2 measurements. Whole Body 1 measurements are more general
in their value, indicative of conditions and events that encompass
the organism as a whole such as cardiac or renal failure and acute
dehydration. Regional 2 measurements provide a site-specific
assessment of fluid volumes such as those found with pleural
effusion in the chest, ascites in the abdomen or even cerebral
edema. The changes of measured electrical values precede changes
seen on x-ray, physical examination, or from laboratory
studies.
[0053] Once again, increasing ohms of resistance indicate a drying
and fluid reduction while decreasing ohms of resistance indicate
increased fluid volumes. Thoracic resistance values that are
increasing indicate a drying chest and conversely decreasing
resistance values indicate additional accumulation of fluid. These
changes clearly indicate the improvement or worsening of disease
conditions and the individual's response to treatment and ergo, its
effectiveness. The extent and aggressiveness of therapy can be
altered and modified to "optimize" the beneficial effects.
[0054] Reactance values are proportional to the number and
integrity (health) of cell wall membranes so when cells increase or
decrease reactance values follow. The cells that change in this
manner are those of the somatic and visceral protein tissues, such
as skeletal musculature organs such as the liver, spleen, lungs,
heart stomach and intestines. Cellular alterations are generally
slower to occur and are affected by metabolic and specific disease
processes. However, overly aggressive diuresis, excessive
hemodialysis or cellular targeted pathologies such as
Rhabdomyolysis can all result in rapid, days versus a week, changes
in cell mass, membrane status and measured reactance values.
Excursions from the baseline or initial measurement value indicate
the type and progression of disease and/or the effectiveness of
treatment interventions. Increased cells (membranes) and anabolic
metabolism are evidenced by a rise in the ohms of reactance,
generally a sign of improvement. A slowly decreasing ohm value of
reactance indicates a negative or catabolic metabolism condition. A
more precipitous and rapid decrease in reactance is indicative of
unique conditions that rapidly affect cells and their membranes,
such as the effect of Rhabdomyolysis skeletal muscle or rejection
or infection of an organ system.
[0055] Regional measurement values of ohms of reactance are used
for these disease specific investigations while whole body values
are used for the assessment of metabolic evaluation.
[0056] A derivative of the measured values of resistance and
reactance is the arc tangent of reactance to resistance expressed
in degrees or Phase Angle. Phase Angle is the cumulative expression
of the changes and ratios of cell mass and extracellular fluid that
result from disease, insult and/or treatment intervention and can
by itself be used to gauge the severity and progression of
pathologies and the effectiveness and benefits of treatment. A
positive prognosis is indicated by an increasing phase angle while
a poor prognosis is associated with a phase angle decrease. Phase
angle has been correlated with survival and the timing of non-acute
death. Phase angle can be derived from both whole body and regional
measurements and followed serially to establish prognosis.
[0057] Treatment interventions can be measured for their
effectiveness on the individual patient by following phase angle.
More effective treatments are evidenced by an increasing phase
angle while those less effective are seen as producing little or no
increase. Once phase angle degrades to below four degrees, the
patient is seriously ill and treatment should be aggressive and
modified to be effective and optimal. If phase angle does not
stabilize or increase through multiple iterations of treatment, a
curative or restorative treatment goal outcome is doubtful. A phase
angle of less than two degrees is associated with pending mortality
and a need for palliative care and comfort. Admission to a hospice
can be objectively based upon phase angle monitoring providing the
patient with improved end-of-life care and comfort.
[0058] FIG. 2 illustrates how electrodes may be placed on the hand
for the BIA Testing Procedure.
[0059] The detecting electrode edge 8 is placed on an imaginary
line bisecting the ulna head (bone on little finger side of
wrist).
[0060] The signal electrode 9 is placed on the first joint of the
middle finger.
[0061] FIG. 3 illustrates how electrodes may be placed on the
foot.
[0062] The detecting electrode edge 10 is placed on an imaginary
line bisecting the medial mellealus (bone on big toe side of
ankle).
[0063] The signal electrode 11 is placed on the base of the second
toe.
[0064] The exam area should be comfortable and free of drafts and
portable electric heaters. The exam table surface must be
non-conductive and large enough for the subject to line supine with
the arms 30 degrees from the body, and legs not in contact with
each other.
[0065] The subject should not have exercised or taken a sauna
within 18 hours of the study. The subject should refrain from
alcohol intake for 12 hours prior to the study. The subject's
height and weight should be accurately measured and recorded. The
subject should lie quietly during the entire test. The subject
should not be wet from sweat or urine.
[0066] The subject should not have a fever or be in shock. The
study and testing procedure should be explained to the subject.
[0067] The subject should remove the shoe and sock and any jewelry
on the electrode side (generally the study is completed on the
right side of the body). The body side (left or right) should
always be used subsequently.
[0068] The subject should lie supine with the arms 30 degrees from
the body with legs not touching.
[0069] The electrode sites may be cleaned with alcohol,
particularly if the skin is dry or covered with lotion.
[0070] The electrodes and patient cables are attached as shown in
FIGS. 2 and 3.
[0071] The analyzer is turned on, making sure the subject refrains
from moving. When the measurements have stabilized, record the
displayed Resistance (R) and Reactance (Xc) with the subject's
name, age, gender, height and weight.
[0072] The entire testing time is less than 5 minutes--the BIA
analyzer is on for less than one minute.
[0073] The results are available immediately from the software
program.
[0074] The study may be repeated as often as necessary.
[0075] The present invention also embraces the features of using
the invention for various areas of interest, for example,
whole-body thoracic, abdominal, extremity, etc.
[0076] Although the invention has been described in detail in the
foregoing only for the purpose of illustration, it is to be
understood that such detail is solely for that purpose and that
variations and modifications can be made therein by those of
ordinary skill in the art without departing from the spirit and
scope of the invention including all equivalents thereof.
* * * * *