Patents; "Method of Detecting Recirculation in an Arteriovenous Shunt during

Ongoing Hemodialysis and Dialysis System" in Patent Application Approval

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Politics & Government Week (Oct 23, 2014): 2759.
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"In particular, the present invention relates to a dialysis machine control

method for the machine-side (not patient-side) detection of recirculation in an
arteriovenous shunt of a patient preferably during ongoing hemodialysis by
means of the dialysis machine itself, wherein the dialysis machine or the
dialysis system has a side facing away from the patient (dialysis fluid side)
and a side facing the patient (blood side); "wherein on the dialysis fluid side
of the dialysis system at least one dialysis fluid inlet as well as at least one
dialysis fluid discharge for a selected dialysis fluid and at least one
fluid/dialysis fluid pump are provided which are in fluidic communication with
at least one dialyser having a semipermeable membrane that forms the
boundary between the dialysis fluid side and the blood side; and wherein the
dialysis fluid on the dialysis fluid side of the membrane flows through a
dialysis fluid chamber of the dialyser in a predetermined direction; "wherein
on the blood side of the dialysis system in an extracorporeal circulatory
branch a blood pump is provided which is adapted to guide blood through a
blood chamber of the dialyser so as to remove uremic toxins by diffusion via
the semipermeable membrane from the extracorporeal-guided blood;
"wherein "a sensor for detecting a change of a physicochemical parameter
P.sub.D of the outflowing used dialysis fluid is provided in the distal fluidics;
and control elements are arranged in the distal fluidics so that the dialysis
fluid is optionally guided unchanged through/along the sensor before entry
into the dialyser chamber; thereby the sensor being calibrated with unused
(pure) dialysis fluid; "and wherein "the control elements are set after
calibration so that the dialysis fluid flows through the dialyser chamber and in
the blood-side extracorporeal circulatory branch a desired first blood flow
value BF.sub.1 is set, thereby a recirculation R occurring between an inlet of
the extracorporeal circulatory branch and an outlet of the extracorporeal
circulatory branch and the parameter detected by the sensor adopting a
value P.sub.D1; "the first blood flow value BF.sub.1 is changed to a second
blood flow value BF.sub.2, wherein a new parameter value P.sub.D2 is

provided and detected at the sensor; "and the course of change (or the
change) from P.sub.D1 to P.sub.D2 is used to detect or determine the
recirculation in response to the way of the course of change (of the change).

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2014 OCT 23 (VerticalNews) -- By a News Reporter-Staff News Editor at

Politics & Government Week -- A patent application by the inventors KRAUSE,
SILVIE (MELSUNGEN, DE); STROHHOEFER, CHRISTOF (KASSEL, DE); AHRENS,
JOERN (BAUNATAL, DE); CASTELLARNAU, ALEX (MELSUNGEN, DE); WEYER,
SOEREN (AACHEN, DE), filed on March 10, 2014, was made available online
on October 9, 2014, according to news reporting originating from Washington,
D.C., by VerticalNews correspondents.

This patent application has not been assigned to a company or institution.

The following quote was obtained by the news editors from the background
information supplied by the inventors: "The present invention relates to a
method of detecting recirculation in an arteriovenous shunt of a patient
during ongoing hemodialysis.

"Patients suffering from severe kidney insufficiency or kidney failure require

dialysis, as is known. For this, the patients concerned have two options of
dialysis, on the one hand in a dialysis center of a hospital and, on the other
hand, self-dialysis in the domestic area with ambulant dialysis units--after
having been introduced by the nephrologist in charge and trained specialized
staff--.

"For the purpose of the present invention, by the term 'dialysis' or

'hemodialysis' any chronically applicable blood purification therapy is
understood which comprises hemodialysis, hemofiltration and

hemodiafiltration.

"For performing dialysis in a patient suffering from chronic kidney

insufficiency typically a so called arteriovenous shunt constituting a direct
connection of an artery to a vein is laid by operation. One of the most
frequent shunts laid for dialysis treatment is the so called Cimino shunt in
which--after vascular preparation--the radial artery is connected to the
cephalic vein.

"Such shunt permits a simple vascular puncture for receiving the cannulas
required for dialysis and moreover has a sufficient blood flow for performing
hemodialysis due to the pressure and flow conditions prevailing in the shunt."

In addition to the background information obtained for this patent application,

VerticalNews journalists also obtained the inventors' summary information for
this patent application: "Based on the state of the art of bolus methods for
determining recirculation, it is therefore an object of the present invention to
provide a method and an apparatus for fully automatic measurement of an
access recirculation in a patient requiring dialysis.

"In particular, the present invention relates to a dialysis machine control

method for the machine-side (not patient-side) detection of recirculation in an
arteriovenous shunt of a patient preferably during ongoing hemodialysis by
means of the dialysis machine itself, wherein the dialysis machine or the
dialysis system has a side facing away from the patient (dialysis fluid side)
and a side facing the patient (blood side);

"wherein on the dialysis fluid side of the dialysis system at least one dialysis
fluid inlet as well as at least one dialysis fluid discharge for a selected dialysis
fluid and at least one fluid/dialysis fluid pump are provided which are in fluidic
communication with at least one dialyser having a semipermeable membrane
that forms the boundary between the dialysis fluid side and the blood side;
and wherein the dialysis fluid on the dialysis fluid side of the membrane flows
through a dialysis fluid chamber of the dialyser in a predetermined direction;

"wherein on the blood side of the dialysis system in an extracorporeal

circulatory branch a blood pump is provided which is adapted to guide blood

through a blood chamber of the dialyser so as to remove uremic toxins by
diffusion via the semipermeable membrane from the extracorporeal-guided
blood;

"wherein

"a sensor for detecting a change of a physicochemical parameter P.sub.D of

the outflowing used dialysis fluid is provided in the distal fluidics; and control
elements are arranged in the distal fluidics so that the dialysis fluid is
optionally guided unchanged through/along the sensor before entry into the
dialyser chamber; thereby the sensor being calibrated with unused (pure)
dialysis fluid;

"and wherein

"the control elements are set after calibration so that the dialysis fluid flows
through the dialyser chamber and in the blood-side extracorporeal circulatory
branch a desired first blood flow value BF.sub.1 is set, thereby a recirculation
R occurring between an inlet of the extracorporeal circulatory branch and an
outlet of the extracorporeal circulatory branch and the parameter detected
by the sensor adopting a value P.sub.D1;

"the first blood flow value BF.sub.1 is changed to a second blood flow value
BF.sub.2, wherein a new parameter value P.sub.D2 is provided and detected
at the sensor;

"and the course of change (or the change) from P.sub.D1 to P.sub.D2 is used
to detect or determine the recirculation in response to the way of the course
of change (of the change). It is outlined in the context that the recirculation is
zero or negligible, respectively, or at least known for at least one out of the
first and second blood flow values.

"Moreover, the present invention relates to a dialysis machine or a dialysis

system comprising a means for detecting recirculation in a blood inlet/outlet

element, preferably an arteriovenous shunt, of a patient during ongoing
hemodialysis, wherein the dialysis system has a side facing away from the
patient (dialysis fluid side) and a side facing the patient (blood side);

"wherein on the dialysis fluid side of the dialysis system at least one dialysis
fluid inlet as well as at least one dialysis fluid discharge for a selected dialysis
fluid and at least one dialysis fluid pump are provided, the latter being in
fluidic communication with at least one dialyser having a semipermeable
membrane which forms the boundary between the dialysis fluid side and the
blood side; and wherein the dialysis fluid on the dialysis fluid side of the
membrane flows through a dialysis fluid chamber of the dialyser in a
predetermined direction;

"wherein on the blood side of the dialysis system blood can be guided in an
extracorporeal circulatory branch by means of a blood pump preferably in a
direction opposite to the flow direction of the dialysis fluid through a blood
chamber so as to remove uremic toxins especially by diffusion through the
semipermeable membrane out of the extracorporeal-guided blood;

"wherein

"at least one sensor for detecting a change or a course of change of a

physicochemical parameter P.sub.D (e.g. absorption, absorbance etc.) of the
outflowing used dialysis fluid is provided in the distal fluidics; and preferably
control means are arranged in the distal fluidics so that the dialysis fluid flows
unchanged through/along the sensor in a selected manner before entering
the dialyser chamber so as to further preferably perform calibration of the
sensor with pure/unused dialysis fluid;

"the control means can be set/are set after (optional) calibration so that the
dialysis fluid flows through the dialyser chamber and in the proximal
extracorporeal circulatory branch a desired first blood flow value BF.sub.1 can
be set/is set, whereby between the inlet of the extracorporeal circulatory
branch and an outlet of the extracorporeal circulatory branch recirculation R
occurs and the parameter detected by the sensor has a value P.sub.D1;

"the first blood flow value BF.sub.1 can be changed (for example in a jumplike, ramp-like manner etc.) to a second blood flow value BF.sub.2 (preferably
by means of a blood pump), a new second parameter value P.sub.D2 being
provided at the sensor; and

"means are provided for detecting the course of change and/or the change
from P.sub.D1 to P.sub.D2 and for determining the recirculation R therefrom.

"A preferred method is such in which an optical absorption, especially

absorption in the IR wavelength range, UV wavelength range or in the visible
wavelength range, or an adequate absorbance is employed as
physicochemical parameter P.sub.D.

"In practice it has turned out to be advantageous to use UV absorption and/or

UV absorbance as physicochemical parameter P.sub.D. In particular LED are
used which emit UV light at a wavelength of approx. 280 nm. Expediently, for
detection of the absorption as to quantity (absorbance) a UV detector is used
as sensor. The advantage of the wavelength range used is that substances
usually eliminated with the urine show good absorptions within this range,
whereby high sensitivity can be obtained while making use of standard
components.

"In a preferred embodiment of the method according to aspects of the

invention, the second blood flow value BF.sub.2 is (preferably considerably)
lower than the first blood flow value BF.sub.1, wherein especially
BF.sub.2=r.times.BF.sub.1 is applicable, preferably with r=0.05 to 0.95. That
is to say, the value BF.sub.2 can be definitely or even only minimally lower
than the value BF.sub.I, namely further preferably depending on the
operating range of the currently used blood pump.

"By such condition the blood flow can be set to a value lying below the
natural shunt flow. In such case, the recirculation in the shunt is zero as an
excellent approximation so that, when recirculation is provided, an easily
detectable change is resulting for the physicochemical parameter in the
dialysis blood flow set for therapy.

"However, it can also be beneficial to tread the inverse path in which the
second blood flow value BF.sub.2 is (preferably considerably) higher than the
first blood flow value BF.sub.1, wherein especially BF.sub.2=r.times.BF.sub.1 is
applicable, preferably with r=1.05 to 20, namely equally preferably in
response to the currently used blood pump. In this case, the preferred
operating range of the blood pump would be (as also in the afore-mentioned
indication) between 30 ml/min and 600 ml/min. In this context, it is expressly
referred to the fact, however, that said operating range of the blood pump
can also be fixed to a different value, wherein then depending hereon the
difference between the two blood flow values would be determined differently
(i.e. outside the afore-mentioned ranges).

"A further preferred embodiment of the method according to aspects of the

invention is characterized in that the recirculation R is detected by a transient
behavior of the time course of the change of the physicochemical parameter
P.sub.D after change of the first blood flow BF.sub.1 to the second blood flow
BF.sub.2.

"By such transient analysis it is achieved that the present invention provides
reliable data of recirculation as to quantity and/or quality during dialysis
without requiring any external measures such as bolus injections.

"A preferred implementation of the transient analysis is a method in which

the transient behavior is detected by a damping .delta. and by means of the
damping .delta. (delta) of the transient behavior after applying the second
blood flow BF.sub.2 the recirculation R is determined by an appropriate
algorithm explained in detail in the examples.

"The transient analysis can alternatively be implemented in that the transient

behavior is detected after applying the second blood flow BF.sub.2 by
integration of a normalized time signal, especially having an intensity output
by the sensor, over a defined period of time and in this way the recirculation
R is determined by an appropriate algorithm explained in detail in the
examples.

"The transient analysis can further be alternatively implemented in that the

transient behavior is detected after applying the second blood flow BF.sub.2
by a characteristic time .tau. of a signal increase in the output signal
provided by the sensor and hereby the recirculation R is determined by an
appropriate algorithm explained in detail in the examples.

"A particular advantage of the different methods of transient analysis is

substantiated in the fact that the results of at least two different methods for
forming a mean value are used to carry out plausibility tests and/or to
increase the accuracy.

"For monitoring the pressure conditions, the current operation and the correct
connection of the blood inlet/outlet element, preferably shunts at the
proximal side of the dialysis system, in the dialysis system pressure sensors
can be provided for the dialyser in the proximal circulation for the arterial
pressure (PA), the venous pressure (PV) and the input pressure (pressure
before entrance [PBE]). If an evaluation of the pressure sensors exceeds or
falls below pre-programmed thresholds, pre-programmed control measures
are initiated where appropriate.

"With the aid of the present invention it is possible to perform measurement

for determining the recirculation in the shunt without influencing the blood
side by a bolus. Thus it is possible to perform punctual measurements
without additional measuring instruments being required.

"Therefore, the method and the apparatus according to the present invention
offer the following advantages: The situation at the patient's access can be
monitored online No bolus injection has to be used A transient signal
measured by means of a sensor on the dialysate side is analyzed after
change of the system condition Preferably an optical sensor, especially an UV
sensor, can be used The invention permits continuous monitoring of the
shunt situation by storing and evaluating the trends of the measurements An
automatic recirculation detection after triggered measurement can be carried
out during the ongoing therapy Short measuring time of less than 4 min is
provided The method and the apparatus are inexpensive as a sensor system
provided anyway can be used Little technical equipment required
Measurement is carried out on the dialysis fluid side so that no interaction of
the sensor with the patient's blood occurs so that no microbiological

contamination has to be feared By measurement on the dialysis fluid side the

nursing staff does not have additional work with preparing the dialysis system
and inserting the blood tube system into the sensors Measurement requires
no staff-intensive step. BRIEF DESCRIPTION OF THE DRAWINGS

"The invention is best understood from the following detailed description

when read in connection with the accompanying drawings. Included in the
drawings are the following figures:

"FIG. 1 shows a schematic representation of the fluidics of an exemplary

dialysis system according to the present invention;

"FIG. 2 is a schematic representation of the fluidics of a proximal side of a

dialysis system with recirculation in the shunt during therapy;

"FIG. 3 is a schematic representation of recirculation with different blood

flows;

"FIG. 4 is a diagram of a transient phenomenon of a detected signal with and

without recirculation (from level 0 to level 2);

"FIG. 5 shows a diagram for the correlation between damping .delta. and
recirculation in the shunt;

"FIG. 6 shows a diagram for the correlation of the recirculation and (1-.delta.);

"FIG. 7 shows dialyser recirculation characteristics for different dialysers;

"FIG. 8 is a diagram for the correlation of the recirculation and (1-.delta.) with
different blood flows for a selected dialyser;

"FIG. 9 is a diagram representation of the determined integral of the

normalized time signal;

"FIG. 10 is a diagram representation of the correlation between the integral

and the recirculation for different dialysers;

"FIG. 11 is a diagram representation of the dependence of the integral on the

blood flow;

"FIG. 12 is a diagram representation of the characteristic time .tau. of a signal

increase;

"FIG. 13 is a diagram representation of the normalized intensity signals and

the time constant .tau. at different recirculation levels;

"FIG. 14 is a diagram representation of the dependence of the time

constant .tau. on the dialyser used;

"FIG. 15 is a diagram representation of the dependence of the time

constant .tau. on the blood flow set;

"FIG. 16 is a clearance diagram in the case of a small change of the blood

flow which calculates the relation of efficient clearance versus dialyser
clearance diagrammatically in a model;

"FIG. 17 diagrammatically measures the relation of efficient clearance versus

dialyser clearance, and

"FIG. 18 is a diagram representation of an example of a change of absorption

with a small change of the blood flow."

URL and more information on this patent application, see: KRAUSE, SILVIE;
STROHHOEFER, CHRISTOF; AHRENS, JOERN; CASTELLARNAU, ALEX; WEYER,
SOEREN. Method of Detecting Recirculation in an Arteriovenous Shunt during
Ongoing Hemodialysis and Dialysis System. Filed March 10, 2014 and posted
October 9, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?
Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearchadv.html&r=1790&p=36&f=G&l=50&d=PG01&S1=20141002.PD.&OS=PD/2
0141002&RS=PD/20141002

Keywords for this news article include: Patents, Therapy, Algorithms,

Hemodialysis, Renal Dialysis.

Our reports deliver fact-based news of research and discoveries from around
the world. Copyright 2014, NewsRx LLC
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Copyright 2014, NewsRx LLC

Indexing (details)
Cite
Subject
Inventors;
Bowel disease;
Hemodialysis;
Sensors
Title
Patents; "Method of Detecting Recirculation in an Arteriovenous Shunt during
Ongoing Hemodialysis and Dialysis System" in Patent Application Approval
Process
Publication title
Politics & Government Week
First page

2759
Publication year
2014
Publication date
Oct 23, 2014
Year
2014
Publisher
NewsRx
Place of publication
Atlanta
Country of publication
United States
Publication subject
Political Science
ISSN
1944-2696
Source type
Trade Journals
Language of publication
English
Document type
Expanded Reporting
ProQuest document ID
1612260008
Document URL

http://search.proquest.com/docview/1612260008?accountid=38628
Copyright
Copyright 2014, NewsRx LLC
Last updated
2014-10-16
Database
ProQuest Agriculture Journals