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ENT 318/3

Artificial Organs

CONTROL DESIGN OF
VAD

Lecturer
Normahira Mamat @ Mohamad Nor
normahira@unimap.edu.my

VAD Design Consideration

What is design ?
Designing is the intellectual attempt to meet certain demands in the
best possible way. It is an engineering activity that impinges on nearly
every sphere of human life, relies on the discoveries and laws of
science, and creates the conditions for applying these laws to the
manufacture of useful products
Pahl, G. and Beitz, W. (1977). Engineering Design, Berlin Heidelberg, Springer-Verlag

1. DEFINE THE PROBLEM

How to define a problem?


Begin with writing specific design specification and requirement.
General statement for heart assist device problem :
To develop a device that when implanted in the human will provide a longer
and better quality of life than conventional pharmacologic or transplant.

VAD Design Consideration


A. FIT OF THE SYSTEM

Decide who the device intended for.


Device fit in patient.
Cause minimal or no pathologic conditions.
Consider volume, mass, dimension, location of tubes, conduits, connectors.
Physical attributes hard, soft, smooth, rough, sharp corners damage
tissues.
Should not project heat.
Effect of device movement and vibration.
Acceptable sound levels at various frequencies.
Meet EM interference, susceptibility standard.

VAD Design Consideration


B. PUMP PERFORMANCE
Performance specified in cardiac output range.
Cardiac output performance obtained at physiologic pressure (left atrial
pressure ~7mmHg, aortic pressure~100mmHg etc).
Control of device must be included.
Device must respond to patients cardiac output requirement.
C. BIOCOMPATIBILITY
Device must not cause excessive damage to biologic system.
Minimally thrombogenic and minimally hemolytic.
Minimal effect on immune system.
Should not promote infection, calcification, tissue necrosis.

VAD Design Consideration


D. RELIABILITY

Design specification must have :


Target reliability for device (e.g 80% confidence for 2 yrs)
Clarification on components that could be changed if necessary
Deal with any service that device may require.
Example : device design life is 5 yrs but battery replacement at 2 yrs interval
is allowed

E. QUALITY OF LIFE
Designer must specify what is a satisfactory quality of life.
Quality of life must be considered in relation to patients quality of life without
the device.
How much weight older patient can carry?
How often power source required to recharge?
What sound level is acceptable?

VAD Design Consideration


2. CONCEPTUAL DESIGN
Plan treatment of the problem.
Thorough review of literature.
Design of proposed solution is examined
Consider various design that meet specification.
e.g. : Pulsatile or non-pulsatile flow ?
Types of pump?
Consider other non-traditional solutions.
e.g. : employ micro-machines, MEMS, magnetohydrodinamics
Source of energy. Batery, fuel cell, piezoelectric crystal? The performance ?
Control of the device. Should include sensor? Consider performance of
sensor. Consider less or no sensor.

VAD Design Consideration

Pump performance and interaction with biological system.


Selection of materials.

2. DETAILED DESIGN
Initial prototyping and testing.
Evaluation of performance.
- System, manufacturing, cost, etc.
3. LEARN AND GENERALIZE
After design complete.
Learn and generalize the design for further design or implemented the
concept on other device.

Reference :
G. Rosenberg , Artificial Heart and Circulatory Assist Devices in Tissue Engineering and Artificial Organs, J.D. Bronzino, Ed. Florida : CRC
Press, 2006
Go to www.engnetbase.com and find in the search

Control techniques of VAD


Principle goal blood pump controller is to respond the bodys demand for
cardiac output. Since it is not realistic to place sensors in the human body
for long term applications.
Feedback controller automatically adjust the pump speed for perfusion for
different levels of patient activity.
Control Problem for Ventricular Assist Devices

Earliest pulsatile types VADs actuated by air.


- used in a limited and critical care setting
- open-loop mode that allows one or two manual adjustments to
prescribe the eject rate and duty cycle (systole/diastole ratio)

Open-loop design for critical care, supervised by human.


Control adjustment made by operator which is human.
When patient condition change, pump will operate with current setting until
operator manage to identify the changes and make proper adjustment.
Patient condition might change due to change in blood volume, inotropic
level or stress.

Control techniques of VAD

For certain critical event, operator must decide whether to adjust pump or
to call clinician for treatment.
Thus operator is required to provide feedback control and fault detection
to the system.
Problem the inability of the devices to respond automatically to
changes in demand for cardiac output impact the quality of patient life.
For pulsatile pumps, the challenge is to specify pumping rate and control
of blood pressure.
For axial pumps, blood might flow backwards through the pump if
running slow since there is no valve.
If run to fast, pump might draw more blood from ventricle. This will cause
suction in the ventricle.

Manual and auto control system

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Control techniques of VAD


How to Eliminate the Problems?
Human operated device should be abolished if long-term implantation are
to be implemented.
Eliminate the need for human to monitor the device
VAD control system must be able to respond to changes.
Patients status should be monitored to notice change in patients
requirement.
The VAD condition itself should also be monitored to detect hardware
failure, changes in assist device parameters, uncontrollable situation and
dangerous control commands by the controller.
Control a blood pressure to maintain adequate haemodynamics

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Control techniques of VAD


Research done by Pittsburgh University, USA
PROBLEMS
Axial pump run continuously to draw blood from heart.dont have
valve.
If pump run slow, blood flow backward (regurgitant).
If pump run fast, more blood will drawn from heart, produce
negative pressure in ventricle (suction).
Motor speed 9000 rpm, minimum pump flow close to zero and
ventricle pressure peak reach 70 mmHg.
Motor speed 10,000 rpm, pump flow less pulsatile with minimum
greater than zero, ventricle pressure peak at 30mmHg.
Figure in next slide shows how suction occurs.

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Control techniques of VAD

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Control techniques of VAD

At 11,000 rpm, the pulsatile pattern is lost. Ventricular pressure is


consistently less than zero.
- a dangerous condition that must be detected quickly and corrected by
reducing the pump speed before the heart muscle damaged.

Lower limit pump speed must avoid regurgitant flow.


Upper pump speed limited to speed that induce suction in ventricle.
The control problem of rotary pump is to determine appropriate reference
speed between this limits.

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Control techniques of VAD


PULSATILITY INDEX
Pulsatility in pump flow signal can be used to define pulsatility index.
Hemodynamic signal (aortic pressure, ventricle pressure) produce
varying degree of pulsatility.
Thus, pump load will be pulsatile which make pump flow and motor
drive current pulsatile.
As pump speed increase, pulsatility decrease.
Pulsatility index used as control signal.
Speed change until pulsatility index equal reference value.
Reference value will hold speed above minimum pulsatility value
corresponds to suction.

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Control techniques of VAD

Thus, this technique attempt to operate the pump at a speed just


below suction.
Provide maximum safe cardiac output.
Fuzzy-logic controller has been used for this task.
In this controller, the law is that when index higher than reference,
speed increased to reduce index & vice versa.
PROBLEM WITH PULSATILITY INDEX
Does not consider other hemodynamic parameters.
When systemic vascular resistance increase, pump output reduce
which will increase pump speed.
Increasing speed of pump might increase arterial pressure to
region outside physiological range.
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Cardiac output

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Speed changes made to keep the pump operating just below


suction.
SVR = systemic vascular resistance
At speed 1, the pump operating is intersection of the pump
pressure-flow with SVR1 line-normal physiologic range.
At speed 2, SVR2 increase which reduces pump output. Arterial
pressure may increase and operating point outside the physiologic
range.
In this case, pump operation at the lower speed might be desirable.

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Control techniques of VAD


MULTIOBJECTIVE OPTIMIZATION
Common constraint for VAD :
1. Cardiac output above minimum value (3-6 L/min).
2. LAP below 10-15 mmHg to avoid pulmonary edema and above 0
mmHg to avoid suction.
3. Systolic arterial pressure maintained between patient-specific limits
to assure adequate perfusion
Formulate control problem solution to meet constraints as
optimization.
There is three control outputs i.e. cardiac output K, arterial pressure
A, left atrial pressure F.
Penalty functions applied on those three control outputs.
If controlled output far from desired point it receive large penalty, if
close to desired point it receive small/zero penalty.

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Control techniques of VAD

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Control techniques of VAD


Multiobjective optimization

Multiobjective optimization considers all criteria of interest.


Provide most satisfactory approach to specifying pump speed.
Requires the most information about patient.
Performance measure defined as :
J() = [J1(), J2(), J3()]
Where is the speed of pump and J1, J2 and J3 are penalties
assigned to cardiac output K(), arterial pressure A() and left
atrial pressure F() respectively.

To determine the penalties associated with different pump


speeds, the functions K(), A(), and F() are needed.

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Control techniques of VAD


These relations depend on pump characteristics, the state of the
natural heart, and the systemic circulation parameters, and they
can be expected to vary with time.
Model of the patients cardiovascular system is used to relate
pump speed to hemodynamic variables.
If natural heart very weak, VAD provide most of blood flow,
ventricular pressure close to zero, total cardiac output is
essentially equal to the pump flow and arterial pressure approx
equivalent to the pressure developed across pump.
If natural heart provide some output, total flow may exceed pump
flow, and arterial pressure depends on natural heart.
A simple model with minimum number of parameters must be
used, since the are patient-specific and must be estimated for
each individual.

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Multi-objective optimization
Most satisfactory approach to specifying pump speed.
Additional crtiteria can always be added as the clinicians
feel appropriate for the patient or as sensor inputs.
Requires the most information about the patient.

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Control architecture

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A local control algorithm built into the pump maintains pump speed
at a reference value.
The reference speed is determined by one of several algorithms
(optimal, heuristic, or default), depending on the patients physical
condition, device status, and confidence that accurate
measurements or estimates of hemodynamic variables are available

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The default control mode can be used in the event of extensive


sensor failure, software failure, or uncertainty concerning the
reliability of control actions or functioning of the assist device itself.
The default mode provides a constant pump speed that is low
enough in most cases to avoid suction while still providing a nominal
flow output.
This mode attempts to provide safe operation of the device without
requiring any sensory information, state variables, or model
parameter estimates.

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Control techniques of VAD

The controller should respond to changes in demand for cardiac


output.
Cardiac signals may be of limited use in early implantation, since
patients will often have abnormal cardiovascular status.
However, if cardiac recovery is obtained, these signals will become
of greater value.
The potential contribution for multiple sensors, but they caution
against incorporating multiple sensors that do not contribute
independent information, due to the increased complexity.

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Control techniques of VAD

The control system, as well as the assist device itself, must be


reliable, and it must be able to react appropriately to hardware
failures.
Device and patient-adaptive cardiovascular models can be used to
determine the reference pump speed and evaluate device
performance, and the hierarchical control structure can decide
which model approach to use.
However, obtaining adequate information to identify the models in
real time remains a significant challenge.

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Control techniques of VAD


REFERENCES/SUPPLEMENT READING

J.F. Antaki, J.R. Boston, and M.A. Simaan, Control of Heart


Assist Devices, Proceedings of the 42nd IEEE
Conference on Decision and Control, pp. 4084-4089,
2003.
J.R. Boston, J.F. Antaki, and M.A. Simaan, Hierarchical
Control of Heart-Assist Devices, IEEE Robotics &
Automation Magazine, pp. 54-64 , March 2003.

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