U.S. patent application number 13/954427 was filed with the patent office on 2013-11-28 for simulation of patient drain phase in peritoneal dialysis.
This patent application is currently assigned to Baxter International Inc. The applicant listed for this patent is Baxter International Inc. Invention is credited to Alp Akonur, Ying-Cheng Lo.
Application Number | 20130317795 13/954427 |
Document ID | / |
Family ID | 42115835 |
Filed Date | 2013-11-28 |
United States Patent
Application |
20130317795 |
Kind Code |
A1 |
Akonur; Alp ; et
al. |
November 28, 2013 |
SIMULATION OF PATIENT DRAIN PHASE IN PERITONEAL DIALYSIS
Abstract
A method of modeling a patient's peritoneal dialysis drain phase
includes (a) modeling a first segment of a drain phase curve as
having a constant flowrate, (b) modeling a second segment of the
drain phase curve as having a decaying exponential flowrate, and
(c) ensuring that a drain flowrate does not fall below a certain
level during therapy by incorporating a switching component so that
(i) at a first time the first segment is active while the second
segment is inactive and (ii) at a second time the first segment is
inactive while the second segment is active.
Inventors: |
Akonur; Alp; (Evanston,
IL) ; Lo; Ying-Cheng; (Green Oaks, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Baxter International Inc |
Deerfield |
IL |
US |
|
|
Assignee: |
Baxter International Inc
Deerfield
IL
|
Family ID: |
42115835 |
Appl. No.: |
13/954427 |
Filed: |
July 30, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12389886 |
Feb 20, 2009 |
8521482 |
|
|
13954427 |
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Current U.S.
Class: |
703/2 |
Current CPC
Class: |
A61M 1/282 20140204;
A61M 1/28 20130101; G16H 50/50 20180101 |
Class at
Publication: |
703/2 |
International
Class: |
G06F 19/00 20060101
G06F019/00 |
Claims
1. A method of modeling a patient's peritoneal dialysis drain phase
comprising: modeling a first segment of a drain phase curve as
having a constant flowrate; modeling a second segment of the drain
phase curve as having a decaying exponential flowrate; and ensuring
that a drain flowrate does not fall below a certain level during
therapy by incorporating a switching component so that (i) at a
first time the first segment is active while the second segment is
inactive and (ii) at a second time the first segment is inactive
while the second segment is active.
2. The method of claim 1, which includes setting a flow transition
percentage at which the switching component transitions from the
first segment to the second segment.
3. The method of claim 2, wherein setting the flow transition
percentage includes setting a volume at which the switching
component transitions from the first segment to the second
segment.
4. The method of claim 2, wherein setting the flow transition
percentage includes setting a percentage of time at which the first
segment is active relative to the second segment.
5. The method of claim 1, which includes setting a minimum drain
volume or drain volume percentage that must be met during the drain
phase.
6. The method of claim 1, which further includes determining (i) a
minimum drain percentage or minimum drain volume, (ii) a low
flowrate level, and (iii) a drain phase time that is long enough
for the minimum drain percentage or minimum drain volume to be met
but not long enough for an actual drain flowrate to fall below the
low flowrate level.
7. The method of claim 1, which further includes modeling for the
patient a dwell time for a peritoneal dialysis dwell phase.
8. The method of claim 1, which further includes determining a low
drain flowrate threshold below which therapy is stopped during the
drain phase.
9. The method of claim 1, which includes modeling the constant
flowrate for a particular patient body position taken during the
drain phase.
10. A peritoneal dialysis method comprising: modeling a first
segment of a drain phase curve for a peritoneal dialysis drain
phase as having a constant flowrate; modeling a second segment of
the drain phase curve for the peritoneal dialysis drain phase as
having a decaying exponential flowrate; incorporating a switching
component so that (i) at a first time during the drain phase the
first segment is active while the second segment is inactive and
(ii) at a second time during the drain phase the first segment is
inactive while the second segment is active; using the modeled
first and second drain phase segments and the switching component
to determine at least one of: (i) a drain time for the drain phase,
(ii) a low flowrate setting, or (iii) a minimum drain volume
percentage; and entering at least one of the drain time, the low
flowrate setting, or the minimum drain volume percentage into an
automated peritoneal dialysis ("APD") machine.
11. The method of claim 10, wherein modeling the second drain phase
segment includes empirically calculating a patient specific
decaying exponential constant.
12. The method of claim 11, wherein empirically calculating the
patient specific decaying exponential constant is performed based
upon a drain type, the drain type including (i) a pumped drain or
(ii) a gravity fed drain.
13. The method of claim 11, wherein empirically calculating the
patient specific decaying exponential constant is performed based
upon a pump type, the pump type including (i) a peristaltic pump or
(ii) a membrane pump.
14. A peritoneal dialysis method comprising: modeling a first
segment of a drain phase curve as having a constant flowrate;
modeling a second segment of the drain phase curve as having a
decaying exponential flowrate; incorporating a switching component
so that (i) at a first time the first segment is active while the
second segment is inactive and (ii) at a second time the first
segment is inactive while the second segment is active; and using
the modeled first and second drain phase segments and the switching
component to set in an automated peritoneal dialysis ("APD")
machine at least one of: (i) a low flowrate level; or (ii) a
minimum drain volume percentage.
15. The method of claim 14, which further includes modeling an
appropriate dwell time for the patient and setting the dwell time
into the APD machine.
16. The method of claim 15, which includes using the minimum drain
volume percentage to determine the appropriate dwell time.
17. A peritoneal dialysis method comprising: modeling a first drain
phase curve including (i) a first segment having a constant
flowrate, (ii) a second segment having a decaying exponential
flowrate, and (iii) a switching component that causes the first
segment to be active at a first time while the second segment is
inactive, and the first segment to be inactive at a second time
while the second segment is active; modeling a second drain phase
curve including (i) a first segment having a constant flowrate,
(ii) a second segment having a decaying exponential flowrate, and
(iii) a switching component that causes the first segment to be
active at a first time while the second segment is inactive, and
the first segment to be inactive at a second time while the second
segment is active; selecting one of the first or second drain phase
curves for a peritoneal dialysis treatment; and setting at least
one parameter of the peritoneal dialysis treatment based upon the
selected drain phase curve.
18. The method of claim 17, wherein the at least one parameter
includes at least one of a drain time, a drain volume or a drain
flowrate.
19. The method of claim 17, wherein modeling the first drain phase
curve includes modeling the first drain curve for a first patient
body position, and wherein modeling the second drain phase curve
includes modeling the second drain curve for a second patient body
position.
20. The method of claim 17, wherein the body positions include
standing, sitting or lying down.
Description
PRIORITY
[0001] This application claims priority to and the benefit as a
continuation application of U.S. patent application Ser. No.
12/389,886, filed Feb. 20, 2009, entitled, "Simulation of Patient
Drain Phase in Peritoneal Dialysis", the entire contents of which
is incorporated herein by reference and relied upon.
BACKGROUND
[0002] The present disclosure relates to medical fluid delivery and
in particular to peritoneal dialysis fluid delivery.
[0003] Due to disease or other causes, a person's renal system can
fail. In renal failure of any cause, there are several
physiological derangements. The balance of water, minerals and the
excretion of daily metabolic load is no longer possible in renal
failure. During renal failure, toxic end products of nitrogen
metabolism (urea, creatinine, uric acid, and others) can accumulate
in blood and tissues.
[0004] Kidney failure and reduced kidney function have been treated
with dialysis. Dialysis removes waste, toxins and excess water from
the body that would otherwise have been removed by normal
functioning kidneys. Dialysis treatment for replacement of kidney
functions is critical to many people because the treatment is life
saving. One who has failed kidneys could not continue to live
without replacing at least the filtration functions of the
kidneys.
[0005] One type of dialysis is peritoneal dialysis. Peritoneal
dialysis uses a dialysis solution or "dialysate", which is infused
into a patient's peritoneal cavity through a catheter implanted in
the cavity. The dialysate contacts the patient's peritoneal
membrane in the peritoneal cavity. Waste, toxins and excess water
pass from the patient's bloodstream through the peritoneal membrane
and into the dialysate. The transfer of waste, toxins, and water
from the bloodstream into the dialysate occurs due to diffusion and
osmosis, i.e., an osmotic gradient occurs across the membrane. The
spent dialysate drains from the patient's peritoneal cavity and
removes the waste, toxins and excess water from the patient. This
cycle is repeated.
[0006] There are various types of peritoneal dialysis therapies,
including continuous ambulatory peritoneal dialysis ("CAPD") and
automated peritoneal dialysis ("APD"). CAPD is a manual dialysis
treatment, in which the patient connects an implanted catheter to a
drain and allows a spent dialysate fluid to drain from the
patient's peritoneal cavity. The patient then connects the catheter
to a bag of fresh dialysate and manually infuses fresh dialysate
through the catheter and into the patient's peritoneal cavity. The
patient disconnects the catheter from the fresh dialysate bag and
allows the dialysate to dwell within the cavity to transfer waste,
toxins and excess water from the patient's bloodstream to the
dialysate solution. After a dwell period, the patient repeats the
manual dialysis procedure.
[0007] In CAPD the patient performs several drain, fill, and dwell
cycles during the day, for example, about four times per day. Each
treatment cycle typically takes about four to five hours. APD is
similar to CAPD in that the dialysis treatment includes a drain,
fill, and dwell cycle. APD machines, however, perform four to five
cycles of peritoneal dialysis treatment automatically, typically
overnight while the patient sleeps. Like CAPD, APD machines connect
fluidly to an implanted catheter, to one or more sources or bags of
fresh dialysate and to a fluid drain.
[0008] The APD machines pump fresh dialysate from the dialysate
source, through the catheter, into the patient's peritoneal cavity
and allow the dialysate to dwell within the cavity so that the
transfer of waste, toxins and excess water from the patient's
bloodstream to the dialysate solution can take place. The APD
machines then pump spent dialysate from the peritoneal cavity,
though the catheter, to the drain. APD machines are typically
computer controlled so that the dialysis treatment occurs
automatically when the patient is connected to the dialysis
machine, for example, when the patient sleeps. That is, the APD
systems automatically and sequentially pump fluid into the
peritoneal cavity, allow for a dwell, pump fluid out of the
peritoneal cavity and repeat the procedure. As with the manual
process, several drain, fill, and dwell cycles will occur during
APD. A "last fill" is typically used at the end of APD, which
remains in the peritoneal cavity of the patient when the patient
disconnects from the dialysis machine for the day.
[0009] In both CAPD and APD, the therapy must allow for a certain
amount of time for the patient drain phase. It is important that
the drain phase be sufficiently long to allow the patient to drain
as completely as possible. On the other hand, if too much time is
allowed for the drain phase, that is, the patient is basically
finished draining too far in advance of the end of the drain phase,
then the drain phase is extending needlessly into time that the
patient could be filling or is appending the last fill's dwell
phase needlessly. A need accordingly exists for a way to predict
and optimize drain phase time to allow for the patient to drain
completely or as much as is reasonably possible without needlessly
extending drain time and wasting time that could be used to
increase therapy dwell.
SUMMARY
[0010] The present disclosure sets forth a method and apparatus for
predicting a patient's optimal drain phase time. The optimal drain
phase time is useful for at least two purposes. First, the optimal
drain phase time can be implemented into the patient's continuous
ambulatory peritoneal dialysis ("CAPD") or automated peritoneal
dialysis ("APD") treatment. Second, the optimal drain phase time
can be used in the further modeling of possible treatments or
therapy regimes for the patient, one or more desirable ones of
which can then be selected for actual use. The further treatment or
prescription modeling can be done using a three-pore model as
discussed below.
[0011] The drain phase modeling attempts to match the patient's
actual drain profile given certain inputs. One important patient
specific input is maximum drain flowrate or Q.sub.max. Q.sub.max
typically occurs at the start of the drain. Some patients will
drain more quickly than others due to patient-specific physical
characteristics. Also, the position of the patient affects
Q.sub.max. A patient standing or sitting may drain quicker than if
the same patient is lying down in a supine or prone position.
Q.sub.max is determined in one embodiment by experimentation with
the patient in a drain position that the patient expects to be for
at least most treatments.
[0012] Referring now to the drawings and in particular to FIGS. 1
and 2, typical drain volume and corresponding flowrate profiles,
respectively, are shown. The profiles were derived in a study by
Brandes J. C., Packard, J. W., Walters S. K., Fritsche C.,
Optimization of Dialysate Flow and Mass Transfer During Automated
Peritoneal Dialysis, American Journal of Kidney Diseases, Vol. 25,
No. 4 (April), 1995, pp. 603-610. FIG. 1 shows a constant drop in
drain volume from a full volume of about 2000 ml to a transition
drain volume of about 350 to 400 ml. This constant drop occurs
while flowrate is generally at a maximum, e.g., Q.sub.max, which is
about 350 ml/min as seen in FIG. 2. Below the transition volume,
the volume drains according to a decaying exponential curve. Drain
flowrate after the transition point also slows to zero according to
a similar curve. The transition point in both FIGS. 1 and 2
separates a first segment from a second segment as discussed in
detail below.
[0013] According to the present method and apparatus, an equation
has been formed that models the first and second segments. The
equation relies principally on Q.sub.max for the first segment. The
equation employs a switching component .PHI. that either (i)
switches the first segment portion of the equation on and the
second segment portion of the equation off or (ii) switches the
first segment portion of the equation off and the second segment
portion of the equation on. The transition time (or volume) at
which switching component .PHI. switches from 1 to 0 is determined
empirically, e.g., the duration of the constant high flow Qmax can
be measured for each individual patient, and for a particular drain
position. The second segment portion of the equation also employs
an exponential drain rate constant .alpha., which is patient
specific and is determined empirically. The equation relies
principally on a for the second segment.
[0014] The drain modeling equation can be used in a number of ways.
First, it can be used to form individual settings for flowrate
threshold ("FRT") and/or minimum drain volume ("MDV"). One or both
of FRT and MDV may be set as alarm limits in an automated
peritoneal dialysis ("APD") machine (which can use either gravity
draining or pumped draining)
[0015] Second, the drain modeling equation can be used to more
accurately model a patient's reaction to therapy, e.g., via a
three-pore model. For example, the three-pore model uses a drain
time (or dwell time, which is a function of drain time) in one or
more places to model a particular patient's reaction to a
particular therapy prescription.
[0016] Third, the drain modeling equation can be used to set drain
and dwell times or periods for actual operation of an APD machine,
for example, performing a multiple exchange therapy. Again, the
machine can be a gravity drain machine or drain via a pump.
[0017] Fourth, the drain modeling equation can be used to set drain
times or periods for patients performing manual peritoneal dialysis
or CAPD.
[0018] It is accordingly an advantage of the present disclosure to
provide a method and apparatus that attempt to optimize a drain
phase in peritoneal dialysis.
[0019] It is another advantage of the present disclosure to provide
a method and apparatus that attempt to minimize drain time.
[0020] It is a further advantage of the present disclosure to
provide a method and apparatus that attempt to maximize drain
volume.
[0021] It is yet another advantage of the present disclosure to
provide a method and apparatus that attempt to prevent patient
overfill.
[0022] It is yet a further advantage of the present disclosure to
provide a method and apparatus that attempt to prevent low drain
flowrate alarms.
[0023] It is still another advantage of the present disclosure to
provide a method and apparatus that attempt to improve estimation
of therapy outcome parameters such as UF, urea clearance and
creatinine clearance.
[0024] Additional features and advantages are described herein, and
will be apparent from the following Detailed Description and the
figures.
BRIEF DESCRIPTION OF THE FIGURES
[0025] FIGS. 1 and 2 are drain volume and drain phase flowrate
profiles derived from actual patient data via a study.
[0026] FIGS. 3 and 4 are drain volume and drain phase flowrate
profiles derived via the modeling method and apparatus of the
present disclosure.
[0027] FIG. 5 is a schematic diagram illustrating how the drain
volume modeling method and apparatus of the present disclosure is
used with kinetic modeling of patient therapy outcomes, e.g., using
a three-pore model.
[0028] FIGS. 6A to 6C illustrate a first therapy modeled via
kinetic model using information obtained from the drain volume
modeling method and apparatus of the present disclosure.
[0029] FIG. 7 is a graph illustrating peritoneal volume over time
for the therapy illustrated in FIGS. 6A to 6C.
[0030] FIGS. 8A to 8C illustrate a second therapy modeled via
kinetic model using information obtained from the drain volume
modeling method and apparatus of the present disclosure.
[0031] FIG. 9 is a graph illustrating peritoneal volume over time
for the therapy illustrated in FIGS. 8A to 8C.
DETAILED DESCRIPTION
[0032] The drain volume modeling method and apparatus of the
present disclosure uses the concepts and terminology described
below.
[0033] Maximum drain flowrate, Q.sub.max, is the initial drain
flowrate, which should be a maximum flowrate of the drain flowrate
profile. The present disclosure applies to different kinds of APD
machines. For example, the APD machine can use a gravity fill and
drain, in which the supply bag is placed elevationally above the
patient and the drain bag is placed elevationally below the
patient. For such a machine, Q.sub.max is determined empirically as
discussed below. Q.sub.max is also determined empirically for
continuous ambulatory peritoneal dialysis ("CAPD"), which also uses
gravity for filling and draining The HomeChoice.RTM. machine, made
by the assignee of the present disclosure, pumps spent fluid from
the patient to drain. Here, Q.sub.max is set by the pump speed,
does not need to be determined empirically, and is independent of
the patient's drain position.
[0034] For modeling purposes, Q.sub.max is assumed to remain
constant until the patient drain transitions to an exponential
decay portion or segment of the profile. Q.sub.max is patient
specific and is also patient drain position specific. Q.sub.max is
determined empirically by, for example, weighing the patient's
drain over time for a number of exchanges and then averaging the
resulting rate. Q.sub.max may vary for a patient depending upon
whether the patient is sitting, laying down or standing during
drain. It is contemplated therefore to obtain empirical data for
Q.sub.max while the patient is positioned for drain in a position
that the patient intends to be for most or all drains. It is also
contemplated to obtain empirical data for Q.sub.max while the
patient is in different positions for drain, e.g., one set of data
while the patient is standing for drain, one set of data while the
patient is sitting for drain, and a third set of data while the
patient is laying down for drain. In such case, an automated
peritoneal dialysis ("APD") machine can be programmed to ask the
patient which drain position the patient intends to use for the
current treatment.
[0035] Flow transition percent ("FTP") is the percentage of the
peritoneal volume at which the patient drain transitions from the
first segment, having constant drain flowrate Q.sub.max, to the
second segment having the decaying exponential flowrate. FTP sets
the volume (or percentage of total time) at which switching
component .PHI., discussed in detail herein, switches from 1 to 0.
FTP is patient specific and is determined empirically regardless of
the type of APD machine (gravity drain or pump to drain) used. FTP
may also be dependent upon patient drain position for gravity fed
systems or treatments.
[0036] The second drain profile segment, having the decaying
exponential flowrate, is controlled in large part by a decaying
exponential constant .alpha., which is also patient specific and is
determined empirically regardless of the type of APD machine
(gravity drain or pump to drain) used or if CAPD is performed
instead. .alpha. itself may depend on drain type, pump or gravity,
and perhaps pump type, e.g., peristaltic versus membrane. .alpha.
may also be dependent upon patient drain position for gravity fed
systems or treatments. .alpha. is determined by obtaining multiple
data points (volume for a given time and flowrate for a given time)
during the second or decaying exponential drain flow and volume
segment. Different "potential" values of .alpha. are then plugged
into the second segment of the drain model shown below until a
value of .alpha. that outputs correct volume and correct flowrate
values for the corresponding points in time, or which best match
the measured data, is obtained. .alpha. can for example be in a
range of 0.1 to 0.15.
[0037] One parameter that may be set in the software of an APD
machine for alarm purposes is a minimum drain percentage ("MDP").
MDP sets a drain limit above which the patient's drain volume must
reach during the drain phase. If, for example, the patient does not
drain at least eighty percent of the total spent volume in the
patient's peritoneum, The APD will sound an alarm and therapy may
be halted, preventing the machine from advancing to the next fill
phase until the low drain is addressed. As discussed below, MDP can
be used with the modeled drain profiles to determine an appropriate
dwell time for the patient, in particular, it sets a minimum dwell
time to reach MDP
[0038] Flowrate threshold ("FRT") may also be set in the software
of an APD machine for alarm purposes. FRT sets a minimum drain
flowrate level below which the machine may alarm, for example,
indicating that the drain flowrate is so low that the treatment in
essence is wasting time by continuing drain. FRT can alternatively
be set to define a drain flow limit below which the drain is
stopped. As discussed below, FTP and MDP can be used, alone or in
combination, with the modeled drain profiles to determine an
appropriate dwell time for the patient, which ensures that the
dwell time is long enough for MDP to be met but does not continue
long enough for the drain flowrate to fall below FTP.
[0039] Referring now to FIGS. 3 and 4, drain volume and drain
flowrate profiles are shown, respectively, which have been modeled
to attempt to match the actual drain volume and drain flowrate
profiles of FIGS. 1 and 2. The drain volume profile of FIG. 3 is
obtained via the following equation or algorithm:
V.sub.D=[V.sub.D0-Q.sub.max*t]*.PHI.+[V.sub.D0*e.sup..alpha.t]*(1.PHI.),
wherein [0040] V.sub.D is an instantaneous remaining drain volume
in the patient at time t [0041] V.sub.D0 is an initial patient
drain volume (fill volume plus UF accumulated over previous dwell);
[0042] Q.sub.max discussed above is a starting flowrate and is
assumed to be constant; [0043] .PHI. discussed above is a switching
component (from 1 to 0 at FTP), which is based on time or volume;
[0044] .alpha. discussed above is a decaying exponential constant;
and [0045] t is time.
[0046] The modeled flowrate profile of FIG. 4 is determined by
dividing a change in volume by a corresponding change in time,
e.g., drop from 2300 ml to 1600 ml over first two minutes leading
to flowrate over that period of 350 ml/min. Specific flowrate
values can be obtained via a derivative dV/dT, especially in the
second, non-linear, segment.
[0047] The equation above and resulting profiles of FIGS. 3 and 4
show a first segment that is dependent on V.sub.D0 and Q.sub.max.
V.sub.D0 is the previous fill volume plus an amount of
ultrafiltrate ("UF") removed from the patient over the last dwell.
The amount of UF can be estimated via a three-pore model given
certain parameters, such as patient physiological characteristics
(ability to remove UF), dextrose level of dialysate used and dwell
time. For example, if the patient fill is 2000 ml of fresh
dialysate and it is determined from a patient kinetic model, such
as a three-pore model, or perhaps experimentally, that the patient
will acquire 300 ml of ultrafiltrate over the course of a known
dwell period, V.sub.D0 will be set to 2300 ml. Q.sub.max is
determined empirically or set via pump speed.
[0048] The equation above and resulting profiles of FIGS. 3 and 4
show a second segment that is dependent on V.sub.D0 and .alpha..
.alpha. is determined empirically as discussed above. The
transition point in the above equation occurs when .PHI. switches
from 1 to 0, which is determined empirically. The corresponding
transition point in the profiles of FIGS. 3 and 4 occurs when the
straight line transitions to the curved or exponentially decaying
line.
[0049] Referring now to FIG. 5, a schematic showing fill, dwell and
drain phases of a peritoneal dialysis treatment illustrates how the
drain volume modeling method and apparatus of the present
disclosure interfaces with the kinetic modeling of patient therapy
outcomes, e.g., using a three-pore model. The duration of the fill
phase in APD is set via a pump speed. The duration of the fill
phase in CAPD is determined principally by head height of the fill
bag above the patient.
[0050] Dwell phase duration and drain phase duration are related. A
treatment typically requires multiple, e.g., four, fills that are
made over an entire treatment, e.g., eight hours. The set fill
times leave only so much time for the dwell and drain phases. The
less time needed for drain, the more time left for dwell, which is
desirable from both clearance and UF standpoints.
[0051] Further, accurately modeling an adequate (MDP satisfied) but
efficient (FTP satisfied) allows the dwell phase times to be
determined accurately given the set fill times. The dwell phase
times are important to the kinetic modeling as seen in FIG. 5.
Thus, determining accurate dwell times allows the kinetic modeling
of patient results to different therapy prescriptions to be done
more accurately. One suitable modified three-pore kinetic model is
described in Rippe B., Sterlin G., and Haraldsson B., Computer
Simulations of Peritoneal Fluid Transport in CAPD, Kidney Int.
1991; 40: 315 to 325. Another suitable modified three-pore kinetic
model is described in Vonesh E. F. and Rippe B., Net Fluid
Adsorption Under Membrane Transport Models of Peritoneal Dialysis,
Blood Purif. 1992; 10: 209 to 226, the entire contents of each of
which are incorporated herein by reference and relied upon.
[0052] Referring now to FIGS. 6A to 6C, one example therapy modeled
using a three-pore kinetic model is illustrated. The three-pore
kinetic model used drain times selected from drain volume and drain
flowrate profiles, similar to FIGS. 3 and 4, which were determined
via the equation above. Here, the patient undergoes four exchanges
of two liter fills each, totaling eight liters. PET characteristic
is H or high meaning the patient in general has high toxin and
glucose clearances.
[0053] A modeled drain time and corresponding drain volume is shown
for each cycle in FIG. 6B. In each case, the drain volume met the
MDP requirement of 85%, and the minimum drain flowrate met the FRT
requirement of 75 ml/min, both of which are shown in FIG. 6A. FIG.
6A also shows patient specific parameters, namely, an FTP of 75%
(percentage of drain after which switching component .PHI. changes
from 1 to 0) and a Q.sub.max of 80 ml/min.
[0054] As seen in FIG. 6B, the drain time and drain volume selected
vary from cycle to cycle because initial drain volume V.sub.D0
varies from cycle to cycle. Initial drain volume V.sub.D0 varies
from cycle to cycle because residual volume (volume remaining in
the patient's peritoneum after drain is completed) varies from
cycle to cycle. As seen in FIG. 6B, residual volume jumps from 150
ml after cycle 1 to 537 ml for cycle 2 and then increases more
slowly to 631 ml and 654 ml for cycles three and four.
[0055] FIG. 6C shows the three-pore kinetic model's predicted UF
removed for the therapy of FIG. 6B. FIG. 6B and FIG. 7 (graphing
peak volume over the cycles) highlight one concern about the "four
exchange each of a two liter fill" therapy of FIG. 6B, namely, that
the predicted peak volume of the patient indicates the patient may
become overfilled. A peak volume of roughly 2700 ml may be too high
for many patients.
[0056] Referring now to FIGS. 8A to 8C, a second example therapy
modeled using a three-pore kinetic model is illustrated. The
three-pore kinetic model again used drain times selected from drain
volume and drain flowrate profiles, similar to FIGS. 3 and 4,
calculated via the equation above. Here, instead of four exchanges
of two liter fills each, the patient undergoes a first exchange
using a two liter fill, and then four exchanges each of a 1.5 liter
fill, totaling eight liters like above. PET characteristic is again
high.
[0057] A modeled drain time and corresponding drain volume is shown
for each cycle in FIG. 8B. In each case, the drain volume met the
MDP requirement of 85% and the minimum drain flowrate met the FRT
requirement of 75 ml/min shown in FIG. 8A. FIG. 8A also shows
patient specific parameters of an FTP of 65% and a Q.sub.max of 80
ml/min. As seen in FIG. 8B, the drain time and drain volume vary
from cycle to cycle because initial drain volume V.sub.D0 varies
from cycle to cycle. Here, the first drain volume is the biggest
and the first drain time is the longest because the first fill is
the biggest, namely, two liters versus 1.5 liters for the remaining
four fills. The drain volumes and drain times increase from cycle
two to cycle five because residual volume increases in each
instance from cycle two to cycle five.
[0058] FIGS. 8B and 9 highlight that five exchange or cycle therapy
of FIG. 8B predicts a reduction of the maximum peak volume to
roughly 2350 ml, which may be better suited for the particular
patient. FIG. 8C shows the three-pore kinetic model's predicted UF
removed for the therapy of FIG. 8B. The UF removed and overall
clearances are comparable to those of FIG. 6C, and the patient
absorbs less glucose, which is beneficial because the patient does
not gain as much weight. Thus, assuming that the additional
exchange can be done in a prescribed or desired total therapy
duration, the therapy of FIG. 8B may be more desirable than the
therapy of FIG. 6B. In any case, the more accurately predicted
drain times and volumes discussed herein allow the therapies of
FIGS. 6B and 8B to be predicted more accurately, so that a better
and more informed decision can be made for the patient.
[0059] It should be understood that various changes and
modifications to the presently preferred embodiments described
herein will be apparent to those skilled in the art. Such changes
and modifications can be made without departing from the spirit and
scope of the present subject matter and without diminishing its
intended advantages. It is therefore intended that such changes and
modifications be covered by the appended claims.
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