Biomedical Engineering Module IV S5-ECE, 2017

Syllabus
Therapeutic Equipments: Principle, block schematic diagram, working and applications of :
pacemakers, cardiac defibrillators, heart–lung machine, dialyzers, surgical diathermy
equipment, ventilators

I. Therapeutic Equipments:
Equipments that replace certain critical physiological functionalities, or provide needed pain
therapy.

Pacemakers
A device capable of generating artificial pacing impulses and delivering them to the heart is
known as a pacemaker system (commonly called a pacemaker). It consists of pulse generator
and appropriate electrodes.

 The rhythmic beating of the heart is due to the triggering pulses that originate in an
area of specialized tissue in the right atrium of the heart. This area is known as the
sino-atrial node.
 In abnormal situations, if this natural pacemaker ceases to function or becomes
unreliable or if the triggering pulse does not reach the heart muscle because of
blocking by the damaged tissues, the natural and normal synchronization of the heart
action gets disturbed.
 When monitored, this manifests itself through a decrease in the heart rate and changes
in the electrocardiogram (ECG) waveform.
 By giving external electrical stimulation impulses (Fig.1) to the heart muscle, it is
possible to regulate the heart rate. These impulses are given by an electronic
instrument called a 'pacemaker'.

A pacemaker basically consists of two parts:

(i) an electronic unit which generates stimulating impulses of controlled rate and amplitude,
known as pulse generator, and

(ii) the lead which carries the electrical pulses from the pulse generator to the heart. The lead
includes the termination which connects to the pulse generator and the insulated conductors,
which interface with electrodes and terminate within the heart.

ECE, MBITS Page 1

Biomedical Engineering Module IV S5-ECE, 2017

Types of Pacemakers

1. Internal Pacemakers:

 In this entire system is inside the body.

 Permanently implanted in the body whose SA node failed to function properly.
 The system is implanted with the pulse generator placed in a surgically formed pocket
below the right or left cavicle.
 Internal leads connected to electrodes that directly contact surface of myocardium
 Pulse generator must be self contained with a power source capable of continuously
operating the unit for a period of years.

 Above fig shows an RC, reference voltage source, and a comparator determines the
basic pacing rate of the pulse generator.
 Its output signal feeds into a second RC network, the pulse width circuit, which
determines the stimulating pulse duration.
 A third RC network, the rate-limiting circuit, disables the comparator for a preset
interval and thus limits the pacing rate to a maximum of 120 pulses per minute for
most dagfe-component failures.
 The output circuit provides a voltage pulse to stimulate the heart. The voltage monitor
circuit senses cell depletion and the rate slowdown circuit and energy compensation
circuit of this event.
 The rate slowdown circuit shuts off some of the current to the basic timing network to
cause the rate to slow down 8 ± 3 beats per minute when ceil depletion has occurred.
The energy-compensation circuit causes the pulse duration to increase as the battery
voltage decreases, to maintain nearly constant stimulation energy to the heart.
 There is also a feedback loop from the output circuit to the refractory circuit, which
provide a period of time following an output pulse or a sensed R-wave during which
the amplifier will not respond to outside signals.

ECE, MBITS Page 2

Biomedical Engineering Module IV S5-ECE, 2017

 The sensing circuit detects a spontaneous R wave and resets the oscillator timing
capacitor.
 The reversion circuit allows the amplifier to detect a spontaneous R wave in the
presence of low-level continuous wave interference. In the absence of an R wave, this
circuit allows the oscillator to pace at its preset rate ± 1 beat per minute.

2. External Pacemakers

 Employed to restart normal rhythm of heart in case of cardiac standstill.

 An external pacemaker usually consists of an externally worn pulse generator
connected to electrodes located on or within the myocardium.
 Used on patients with temporary heart irregularities.
 In this the pulse generator located outside the body and connected to ventricle using a
long thin tube called catheter.
 The pacing impulse(80 mA) is applied through metal electrodes placed on the surface
of the body.

Types of Pacing Modes

The noncompetitive method, which uses pulse generators that are either ventricular
programmed or programmed by the atria, is more popular. Ventricular-programmed
pacemakers arc designed to operate either in a demand (R-wave-inhibited) or standby (R-
wave-triggered) mode, whereas atrial-programmed pacers are always synchronized with the
P wave of the ECG

ECE, MBITS Page 3

Biomedical Engineering Module IV S5-ECE, 2017

1. Competitive [Fixed Rate or Asynchronous Pacemaker]

 The first (and simplest) pulse generators were fixed-rate or asynchronous devices that
produced pulses at a fixed rate and were independent of any natural cardiac activity:
 A synchronous pacing is called competitive pacing because the fixed-rate impulses
may occur along with natural pacing impulses generated by the heart and would
therefore be in competition with them in controlling the heartbeat. This competition is
largely eliminated through use of ventricular or atrial-programmed pulse generators.

2. Ventricular Programmed

 The problems of shorter battery life and competition for control of the heart led, in
part, to the development of ventricular-programmed (demand or standby) pulse
generators.

 Either type of ventricular-programmed pulse generator, when connected to the

ventricles via electrodes, is able to sense the presence (or. absence) of a naturally
occurring R wave.
 Above figure shows a functional block diagram of a ventricular synchronous demand
pacer.
 The pulse generator has two functions, viz., pacing and sensing. Sensing is
accomplished by picking up the ECG signal.
 In the case of dual-chamber pacing, the P wave is also sensed.
 Once the signal enters the sensing circuit, it is passed through a QRS bandpass filter.
This filter is design to pass signal components in the frequency range of 5-100 Hz,
with a centre frequency of 30 Hz.
 This is followed by an amplifier and threshold detector which is designed to operate
with a detection sensitivity of 1-2 mV. Sensitivity of this order ensures reliable

ECE, MBITS Page 4

Biomedical Engineering Module IV S5-ECE, 2017

detection of cardiac signals sensed on the electrodes which typically have amplitudes
in the 1-30 mV range depending onto 1 electrode surface area and the sensing circuit
loading impedance.
 Refractory period (T1) is necessarily incorporated to limit the pulse delivery rate,
particularly in the ' presence of electromagnetic interference. It is meant to prevent
multiple re-triggering of the astable multivibrator following a sensed or paced
contraction.
 The free-running multivibrator provides a fixed rate mode with an interval of T 2 via
the output driver circuit. The output pulses of a length T3 synchronous with input
signals that fall outside the sensing refractory period T1 are thus delivered at the
stimulating electrodes.

R-wave-inhibited (demand):
 The output of an R-wave-inhibited (demand) unit is suppressed (no output pulses are
produced) as long as natural (intrinsic) R waves are present. Thus, its output is held
back or inhibited when the heart is able to pace itself.
 However, should standstill occur, or should the intrinsic rate fall below the preset rate
of the pacer (around 70 BPM), the unit will automatically provide an output to pace
the heart after an escape interval at the designated rate.
 In this way, ventricular-inhibited pacers are able to pace on demand.
 A demand pacer, in the absence of R waves, automatically reverts to a fixed-rate
mode of operation.
R-wave- triggered :

 R-wave-triggered pulse generators, like the inhibited units, sense each intrinsic R
wave. However, this pacer emits an impulse with the occurrence of each sensed R
wave. Thus, the unit triggered rather than inhibited by each R wave.
 The pacing impulses are transmitted to the myocardium during its absolute refractory
period, so they will have no effect on normal heart activity.

3. Atrial Programmed

 In cases of complete heart block where the atria are able to depolarize but the impulse
fails to depolarize the ventricles, atrial synchronous pacing may be used. Here the
pulse generator is connected through wires and elcetrodes to both the atria and the
Ventricles.
 The atrial electrode couples atrial impulses to the pulse generator, which then emits
impulses to stimulate the ventricles via the ventricular electrode. In this way, the heart
is paced at the same rate as the natural pacemaker.
 When the SA node rate changes because of vagus or sympathetic neuronal control, the
ventricle will change its rate accordingly but not above some maximum rate (about
125 per minute).

ECE, MBITS Page 5

Biomedical Engineering Module IV S5-ECE, 2017

CARDIAC DEFIBRILLATORS

NEED FOR A DEFIBRILLATOR

 Ventricular fibrillation is a serious cardiac emergency resulting from asynchronous

contraction of the heart muscles. This uncoordinated movement of the ventricle walls
of the heart may result from coronary occlusion, from electric shock or from
abnormalities of body chemistry.
 Because of this irregular contraction of the muscle fibres, the ventricles simply quiver
rather than pumping the blood effectively. This results in a steep fall of cardiac output
and can prove fatal if adequate steps are not taken promptly.
 In fibrillation, the main problem is that the heart muscle fibres are continuously
stimulated by adjacent cells so that there is no synchronised succession of events that
follow the heart action. Consequently, control over the normal sequence of cell action
cannot be captured by ordinary stimuli.

DEFIBRILLATOR

 Ventricular fibrillation can be converted into a more efficient rhythm by applying a

high energy shock to the heart. This sudden surge across the heart causes all muscle
fibres to contract simultaneously. Possibly, the fibres may then respond to normal
physiological pacemaking pulses. The instrument for administering the shock is called
a defibrillator.

Restoration of normal rhythm in fibrillating heart as achieved by direct

The shock can be delivered to the heart by means of electrodes placed on the chest of the
patient (external defibrillation) or the electrodes may be held directly against the heart when
the chest is open (internal defibrillation). Higher voltages are required for external
defibrillation than for internal defibrillation.

DC DEFIBRILLATOR

Basic Principle

In this an energy storage capacitor is charged at a relatively slow rate (in the order of
seconds) from the AC line by means of a step-up transformer and rectifier arrangement or
from a battery and a DC to DC converter arrangement. During defibrillation, the energy
stored in the capacitor is then delivered at a relatively rapid rate (in the order of milliseconds)
to the chest of the subject. For effective defibrillation, it is advantageous to adopt some

ECE, MBITS Page 6

Biomedical Engineering Module IV S5-ECE, 2017

shaping of the discharge current pulse. The simplest arrangement involves the discharge of
capacitor energy through the patient's own resistance (R). This yields an exponential
discharge typical of an RC circuit. If the discharge is truncated, so that the ratio of the
duration of the shock to the time constant of decay of the exponential waveform is small, the
pulse of current delivered to the chest has a nearly rectangular shape. For a somewhat larger
ratio, the pulse of current appears nearly trapezoidal. Rectangular and trapezoidal waveforms
have also been found to be effective in the trans-thoracic defibrillation and such waveforms
have been employed in defibrillators designed for clinical use (Schuder et al. 1980).

 The basic circuit diagram of a DC defibrillator is shown in Fig.

 A variable auto-transformer Tj forms the primary of a high voltage transformer T 2.
 The output voltage of the transformer is rectified by a diode rectifier and is connected
to a vacuum type high vol tage change-over switch. In position A, the switch is
connected to one end of an oil-filled 16 micro-farad capacitor.
 In this position, the capacitor charges to a voltage set by the positioning of the auto-
transformer. When the shock is to be delivered to the patient, a foot switch or a push
button mounted on the handle of the electrode is operated. The high voltage switch
changes over to position 'B' and the capacitor is discharged across the heart through
the electrodes.
 In a defibrillator, an enormous voltage (approx. 4000 V) is initially applied to the
patient.

Discharging Pulse of a DC defibrillator

 A typical discharge pulse of the defibrillator is shown in Fig. below.

 The most common waveform utilized in the RLC circuit employs an under-damped
response with a damping lector leas than unity.
 This particular waveform is called a Lown' waveform. This waveform is more or leas
of an oscillatory character, with both positive and negative portion. The pulse width in
this waveform is defined as the time that elapses between the start of the impulse and
the moment that the current intensity passes the zero line for the first time and
changes direction.
ECE, MBITS Page 7
Biomedical Engineering Module IV S5-ECE, 2017

 The pulse duration is usually kept as 5 ms or 2.5 ms.

IMPLANTABLE DEFIBRILLATORS

 An implantable defibrillator is continuously monitors a patient's heart rhythm.

 If the device detects fibrillation, the capacitors within the device are charged up to
750 V. The capacitors then discharged into the heart which mostly represents a
resistive load of 50 ohm and to bring heart into normal rhythm.
 This may require delivery of more than one high energy pulse.
 Implantable defibrillator systems have three main system components: the
defibrillator itself (AID), the lead system, and the programmer recorder/monitor
(PRM). The AID houses the power source, sensing, defibrillation, pacing, and
telemetric communication system. The leads system provides physical and electrical
connection between the defibrillator and the heart tissue. The PRM communicates

ECE, MBITS Page 8

Biomedical Engineering Module IV S5-ECE, 2017

with the implanted AID and allows the physician to view status information and
modify the function of the device as needed.
 Programmer Recorder/Monitor (PRM): The PRM is an external device that provides
a bidirectional communications link to an implanted AID. This telemetry link is
established from a coil which is contained within the wand of the PRM, to a coil
which is contained within the implanted device. This telemetry channel may be used
to retrieve real-time and stored intracardiac ECG, therapy history, battery status, and
other information pertaining to device function. A number of combinations of
programmable therapy and detection options are available and it is not unusual to alter
these prescriptions dozens of times over the life of the implant.
 Leads: Until recently, the defibrillating high energy pulse was delivered to the heart
via a 6 cmx9 cm titanium mesh patch with electrodes placed directly on the external
surface of the heart. Sensing was provided through leads screwed in the heart. This
approach required an invasive surgical approach to provide access to the heart. The
modem implantable defibrillators make use of a single transvenous lead with the
multiple electrodes inserted into the right ventricle for ventricular pacing and
defibrillation.
 Pulse Generator: Major sub-systems of the implanted pulse generator are shown in
Fig. 26.8. It has a microprocessor which controls overall system functions. An 8-bit
device is sufficient for most systems. ROM provides non-volatile memory for system
start-up tasks and some program space,whereas RAM is required for storage of
operating parameters, and storage of electro-cardiogram data. The system control part
includes support circuitry for the microprocessor like a telemetry interface, typically
implemented with a UART-like (universal asynchronous receiver/transmitter)
interface and general purpose timers.
 The power supply to the circuit comes from lithium Silver Vanadium oxide (Li SVO)
batteries. Digital circuits operate from 3 V or lower supplies whereas analog circuits
typically require precision nanoampere current source inputs. Separate voltage
supplies are generated for pacing (approximately 5 V) and control of the charging
circuit (10-15 V),
 High power circuits convert the 3-6 V battery voltage to the 750 V necessary for a
defibrillation pulse, store the energy in high voltage capacitors for timed delivery, and
finally switch the high voltage to cardiac tissue or discharge the high voltage
internally if the cardiac arrhythmia self- terminates. The major components of these
circuits are the battery, the DC to DC converter, the output storage capacitors, and the
high power output switches.
 Commercially available implantable defibrillators all utilize lithium SVO cells, with
the most common configuration being two connected in series to form an
approximately 6 V battery. Unlike 2.8 V lithium iodide (LI) pacemaker cells which
develop high internal impedance as they discharge (up to 20,000 Q over their useful
life), SVO cells are characterized by low internal impedance (less than 1ft) over their
useful life. The output voltage of SVO is higher than LI ranging from 3.2 V for a
fresh cell to approximately 2.5 V when nearly depleted.
 DC to DC converter used to convert the 6 volt battery voltage to 750 V is of classical
configuration. They are operated at as high a frequency (in the range of 30-60 KHz)
as practical to facilitate the use of the smallest possible core.
 The storage capacitors are typically aluminum electrolytics because of the high
volumetric efficiency and working voltage required. Most designs utilize at least two
such capacitors in series

ECE, MBITS Page 9