Design and Implementation of programmable Cardiac Pacemaker Using VHDL
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This document describes the design and implementation of a programmable cardiac pacemaker using VHDL. It discusses how the pacemaker is divided into three main sections: a controlling unit, sensing unit, and pulse generator. The controlling unit and pulse generator are the main focus. Different pacing modes are implemented, including VOO, VVI, AAI, and DDD. The refractory period and AV delay timing features are also discussed. Simulation results validating the implementation of modes AOO, VOO, and DOO are shown. The pacemaker is designed to be programmable for different patients and conditions.
![Omkar Dwivedi Int. Journal of Engineering Research and Applications www.ijera.com
ISSN : 2248-9622, Vol. 5, Issue 5, ( Part -5) May 2015, pp.155-158
www.ijera.com 155 | P a g e
Design and Implementation of programmable Cardiac
Pacemaker Using VHDL
Omkar Dwivedi1
Dr.Geetika Srivastava2
*Department of Electronics & Communication, Amity School of Engineering and Technology
Amity University Lucknow Campus
**Department of Electronics & Communication, Amity School of Engineering and Technology
Amity University Lucknow Campus
Abstract
Pacemaker design has evolved very rapidly over the last several years. There has been a great deal of work in
enhancing the programmability of pacemakers, to enable them to be programmed to work with different selected
operating parameters, and indeed to work in different modes. In Taiwan, about 70%of cardiac
pacemakerpatients are paced only from the ventricle with some pacing parameter programmability. This paper
goal is to design a cardiac pacemaker with various NBG modes. A state machine approach has been followed to
achieve the desired purpose. The pacemaker system is divide into three main sections i.e. controlling unit,
sensing unit and pulse generator. In this paper we mainly concentrate on controlling unit and pulse generator. It
has been developed using VHDL coding and implemented in hardware using FPGA. In a simple pacemaker
process i.e. single chamber or dual chamber pacemaker, first an input signal or an event is detected in heart
through leads. When the input signal is detected a timer generates a delay for approximately 0.8 sec. It is the
time between two consecutive heartbeats, thus giving us 72 heartbeats per minute. Once the generated delay
expires, sensing unit again start detecting a new event. If any event is detected we repeat the process of detection
and waiting. If no event is detected we need to provide an electrical pulse to the heart and then repeat the whole
process of detection and waiting. The code has been optimized and modified for different pacemaker modes.
Keywords-Cardiac pacemaker, NBG codes, pacing mode, Refractory period.
I. Introduction
Heart disease or Cardio Vascular Disease is
quiet normal in every age group now a days.
According to a survey, in England(2007), CVD led
to nearly 159,000 deaths (accounting for nearly 34%
of all deaths in England). This includes 74,185
deaths from coronary heart disease (CHD) and
43,539 from stroke (British Heart Foundation 2009)
[1]. CVD happens due to extreme pressure of
working, imbalance between professional and
personal life and due to some parameters of the
surroundings. It is found that the premature CVD
deaths i.e. deaths in the age group less than 75 years
are preventable. Devices like Defibrillator and
Pacemakers are used as a temporary and permanent
cure to some kind of heart diseases.These devices
are used to correct the heartbeat of the humans. The
design and implementation of these kind of devices
is a complex task as a many lifetime and efficiency
are necessary and very difficult to generate
corresponding to the requirement. Cost, Size and
Efficiency are the important factor that act in the
design of any device and in case of pacemaker
besides these power and lifetime is also an
important factor to be considered. Researchers are
continuously trying to enhance the design of the
pacemaker devices and their development
considering the above factors and because of
theenhancement of the development of the
embedded systems they are capable of reducing
some of the important constraints like cost and size
to some extent. Simulation software are present for
the designing these digital circuits by programming.
II. Programmable cardiac pacemaker
Generally cardiac pacemaker has three main
sections i.e. pulses generator, sensing unit and
controlling unit. Purpose of the pulse generator is to
apply the electrical impulse to the chambers of
theheart on the instruction received from the
controlling unit. A controlling unit is consist of
processor having a decision making capability. An
algorithm or program is embedded into the
processor according which its help in stimulation of
heart. Whereas sensing units gathers the data
through sensors placed at different location of heart.
. There are one or more sensor are used in rate
responsive pacemaker to sense the different body
parameter. These parameter directly or indirectly
increases the consumption of oxygen [2]. Whenever
a change is detected in these parameter, the pacing
rate is adjusted according the variation in parameter.
RESEARCH ARTICLE OPEN ACCESS](https://image.slidesharecdn.com/w50506155158-150801060422-lva1-app6891/85/Design-and-Implementation-of-programmable-Cardiac-Pacemaker-Using-VHDL-1-320.jpg)
![Omkar Dwivedi Int. Journal of Engineering Research and Applications www.ijera.com
ISSN : 2248-9622, Vol. 5, Issue 5, ( Part -5) May 2015, pp.155-158
www.ijera.com 156 | P a g e
For example whenever we perform exercises our
consumption of oxygen increases and in response to
it pacemaker paces the heart at higher rate [3].Block
diagram of cardiac pacemaker is shown in fig.1.
Figure1: Block diagram of cardiac pacemaker
The common types of sensors used in this class of
pacemakers are:
A. Activity sensor
Activity sensor detect and respond to heart about
various level of physical activity done by patient’s
body. These sensor are attached to metallic body of
pacemaker to measure the response of muscle
movement or body movement. These muscle
produces vibration which is identified by the sensor
placed on the pacemaker body [4]. Then these
vibration are converted to the electrical signal which
is guided to the controller of pacemaker. The two
main activity sensors are accelerometers and
vibration Sensors.
B. Physiological sensor
This type of sensors perceive and respond to heart
about different body parameter such as body
temperature, blood pH indications, blood pressure,
respiration rate and concentration of oxygen. For
example normal human body temperatures
fluctuates between 36.8±0.5 °C (98.2±0.9 °F). The
body temperature usually swings all the day, with
the bottommost points around 03:30 a.m. and the
uppermost [5] in the late afternoon, between 03:30
p.m. and 05:30 p.m. As body temperature varies
heart rate changes. Similarly at high altitude the
percentage of oxygen drops. Due to which
concentration level of oxygen drops in blood and
heart rate rise.
III. Timing Features
A. Refractory Periods
Pacemaker have two main functions sensing
and pacing. Since heart is made of three types of
muscles, each muscles have different depolarisation
and repolarisation period. This period can be
defined as interval during which these muscles does
not respond to electrical triggering. So whenever an
event is sensed or an electrical impulse is provided
to heart, the pulse generator initiates a refractory
period for that chamber or sensing channel. After
the starting of refractory period, pulse generator unit
ignores the internal cardiac signals. This process
prevents the pacemaker from responding to the
depolarization signal or the repolarization signal (T-
wave) that may result in inappropriate inhibition or
triggering.
If the pacemaker is programmed to dual chamber
mode then the refractory periods are independently
programmable for atria and ventricle.
B. AV Delay
The AV delay is the time interval between the two
events i.e. An atrial paced or sensed event and the
ventricular pacing pulse. AV delay must be selected
wisely so that an intrinsic ventricular event
occurring within the AV delay will inhibit the
ventricular pacing pulse [6].AV delay must not be
selected to short or to long so that ventricle event is
inhibited. In our pacemaker we have used the
Dynamic AV Delay feature. It provides independent
selection of AV Delays from five different rate
ranges as shown table 1.
Table 1: Dynamic AV delay settings
Rate Ranges Time delay
below 70 bpm 180 ms
70—90 bpm 170 ms
91—110 bpm 160 ms
111—130 bpm 150 ms
above 130 bpm 140 ms
IV. Modes of pacemaker and features
A. VOO
VOO mode is used when ventricle chamber is
unable to propagate the electrical signal to the
purkinje fibres. This mode only pace the ventricles.
Each letter in VOO indicates the function processed
by heart as per NBG (NASPE/BPEG Generic) code.
First letter V indicates that it pace only in ventricles,
second letter O indicates that pacemaker does not
sense any of the chambers and third letter O
indicates that there is no mode of response is used.
VOO mode algorithm is shown in the figure 3.
Figure 3: VOO mode algorithm
Memory
AV
interval
timer
Pacing
interval
timer
Microprocessor
Telemetry Atrial stimulus
generator
Atrial
sense
Ventricular
sense
Ventricular
stimulus
generator
Data bus
To heart
Reset counter
Increment counter
LRI expired?
No Yes
Deliv er pulse](https://image.slidesharecdn.com/w50506155158-150801060422-lva1-app6891/85/Design-and-Implementation-of-programmable-Cardiac-Pacemaker-Using-VHDL-2-320.jpg)
![Omkar Dwivedi Int. Journal of Engineering Research and Applications www.ijera.com
ISSN : 2248-9622, Vol. 5, Issue 5, ( Part -5) May 2015, pp.155-158
www.ijera.com 158 | P a g e
Figure 7: Simulation result of mode VOO.
Figure 8: Simulation result of mode DOO.
Figure 9: Schematic RTL symbol
VII. Conclusion
There are many problem which are discussed
above that need to be improved such as it need to be
made compatible to MRI. Many problem comes in
notice during diagnostic process such as over
sensing or under sensing. These problem may be
solved by selecting correct sensitivity parameter.
We need to understand basic pacing terminology
and modes to treat patients effectively.
VIII. Future scope
Due to development in embedded system,
clinicians can extract the patient diagnostic history
from cardiac pacemaker system. An energy
harvesting technique should be developed which can
power itself from body i.e. no requirement of
battery.
References
[1] “Prevention of cardiovascular Disease”,
NICE public health guidance 25, Issued:
June 2010.
[2] “Assessing cardiac activity”, Benny
Rousso, Rishon-LeZion (IL);
EyalLebanony, Haifa (IL); David Prutchi,
Voorhees, NJ (US); OphirBitton, Zikhron-
Yaakov (IL), Patent N0.:US 8,406,864 B2,
Date of Patent: Mar. 26, 2013.
[3] “Rate adaptive pacemaker”, Mart Min,
Tallinn (EE); Andres Kink, Harjumaa
(EE); ToomasParve, Tallinn (EE), Patent
No.: US 6,885,892 B1, Date of Patent: Apr.
26, 2005.
[4] “Cardiac force sensor and methods of
use”, Yongxing Zhang, Irvine, CA (US);
YunlongZhangs, Mounds View, MN (US);
Xuan Wei, Plymouth, MN (US) Patent
No.US 8,417,355 B2,Date of Patent: Apr.
9, 2013.
[5] “Temperature sensor for a leadless cardiac
pacemaker”, Alan Ostroff, Pleasanton, CA
(U S), Patent No.: US 8,543,205 B2, Date
of Patent: Sep. 24, 2013.
[6] “Reduction of AV delay for treatment of
cardiac disease”, Joseph M. Pastore,
Concord, OH (US); Rodney W. Salo,
Fridley, MN (US); Julio C. Spinelli,
Lakewood Ranch, FL (US); Allan C.
Shuros, St. Paul, MN (US); Andres
Belalcazar, St. Paul, MN (Us) Patent N0.:
US 8,311,630 B2, Date of Patent: Nov. 13,
2012.](https://image.slidesharecdn.com/w50506155158-150801060422-lva1-app6891/85/Design-and-Implementation-of-programmable-Cardiac-Pacemaker-Using-VHDL-4-320.jpg)
Design and Implementation of programmable Cardiac Pacemaker Using VHDL
- 1. Omkar Dwivedi Int. Journal of Engineering Research and Applications www.ijera.com ISSN : 2248-9622, Vol. 5, Issue 5, ( Part -5) May 2015, pp.155-158 www.ijera.com 155 | P a g e Design and Implementation of programmable Cardiac Pacemaker Using VHDL Omkar Dwivedi1 Dr.Geetika Srivastava2 *Department of Electronics & Communication, Amity School of Engineering and Technology Amity University Lucknow Campus **Department of Electronics & Communication, Amity School of Engineering and Technology Amity University Lucknow Campus Abstract Pacemaker design has evolved very rapidly over the last several years. There has been a great deal of work in enhancing the programmability of pacemakers, to enable them to be programmed to work with different selected operating parameters, and indeed to work in different modes. In Taiwan, about 70%of cardiac pacemakerpatients are paced only from the ventricle with some pacing parameter programmability. This paper goal is to design a cardiac pacemaker with various NBG modes. A state machine approach has been followed to achieve the desired purpose. The pacemaker system is divide into three main sections i.e. controlling unit, sensing unit and pulse generator. In this paper we mainly concentrate on controlling unit and pulse generator. It has been developed using VHDL coding and implemented in hardware using FPGA. In a simple pacemaker process i.e. single chamber or dual chamber pacemaker, first an input signal or an event is detected in heart through leads. When the input signal is detected a timer generates a delay for approximately 0.8 sec. It is the time between two consecutive heartbeats, thus giving us 72 heartbeats per minute. Once the generated delay expires, sensing unit again start detecting a new event. If any event is detected we repeat the process of detection and waiting. If no event is detected we need to provide an electrical pulse to the heart and then repeat the whole process of detection and waiting. The code has been optimized and modified for different pacemaker modes. Keywords-Cardiac pacemaker, NBG codes, pacing mode, Refractory period. I. Introduction Heart disease or Cardio Vascular Disease is quiet normal in every age group now a days. According to a survey, in England(2007), CVD led to nearly 159,000 deaths (accounting for nearly 34% of all deaths in England). This includes 74,185 deaths from coronary heart disease (CHD) and 43,539 from stroke (British Heart Foundation 2009) [1]. CVD happens due to extreme pressure of working, imbalance between professional and personal life and due to some parameters of the surroundings. It is found that the premature CVD deaths i.e. deaths in the age group less than 75 years are preventable. Devices like Defibrillator and Pacemakers are used as a temporary and permanent cure to some kind of heart diseases.These devices are used to correct the heartbeat of the humans. The design and implementation of these kind of devices is a complex task as a many lifetime and efficiency are necessary and very difficult to generate corresponding to the requirement. Cost, Size and Efficiency are the important factor that act in the design of any device and in case of pacemaker besides these power and lifetime is also an important factor to be considered. Researchers are continuously trying to enhance the design of the pacemaker devices and their development considering the above factors and because of theenhancement of the development of the embedded systems they are capable of reducing some of the important constraints like cost and size to some extent. Simulation software are present for the designing these digital circuits by programming. II. Programmable cardiac pacemaker Generally cardiac pacemaker has three main sections i.e. pulses generator, sensing unit and controlling unit. Purpose of the pulse generator is to apply the electrical impulse to the chambers of theheart on the instruction received from the controlling unit. A controlling unit is consist of processor having a decision making capability. An algorithm or program is embedded into the processor according which its help in stimulation of heart. Whereas sensing units gathers the data through sensors placed at different location of heart. . There are one or more sensor are used in rate responsive pacemaker to sense the different body parameter. These parameter directly or indirectly increases the consumption of oxygen [2]. Whenever a change is detected in these parameter, the pacing rate is adjusted according the variation in parameter. RESEARCH ARTICLE OPEN ACCESS
- 2. Omkar Dwivedi Int. Journal of Engineering Research and Applications www.ijera.com ISSN : 2248-9622, Vol. 5, Issue 5, ( Part -5) May 2015, pp.155-158 www.ijera.com 156 | P a g e For example whenever we perform exercises our consumption of oxygen increases and in response to it pacemaker paces the heart at higher rate [3].Block diagram of cardiac pacemaker is shown in fig.1. Figure1: Block diagram of cardiac pacemaker The common types of sensors used in this class of pacemakers are: A. Activity sensor Activity sensor detect and respond to heart about various level of physical activity done by patient’s body. These sensor are attached to metallic body of pacemaker to measure the response of muscle movement or body movement. These muscle produces vibration which is identified by the sensor placed on the pacemaker body [4]. Then these vibration are converted to the electrical signal which is guided to the controller of pacemaker. The two main activity sensors are accelerometers and vibration Sensors. B. Physiological sensor This type of sensors perceive and respond to heart about different body parameter such as body temperature, blood pH indications, blood pressure, respiration rate and concentration of oxygen. For example normal human body temperatures fluctuates between 36.8±0.5 °C (98.2±0.9 °F). The body temperature usually swings all the day, with the bottommost points around 03:30 a.m. and the uppermost [5] in the late afternoon, between 03:30 p.m. and 05:30 p.m. As body temperature varies heart rate changes. Similarly at high altitude the percentage of oxygen drops. Due to which concentration level of oxygen drops in blood and heart rate rise. III. Timing Features A. Refractory Periods Pacemaker have two main functions sensing and pacing. Since heart is made of three types of muscles, each muscles have different depolarisation and repolarisation period. This period can be defined as interval during which these muscles does not respond to electrical triggering. So whenever an event is sensed or an electrical impulse is provided to heart, the pulse generator initiates a refractory period for that chamber or sensing channel. After the starting of refractory period, pulse generator unit ignores the internal cardiac signals. This process prevents the pacemaker from responding to the depolarization signal or the repolarization signal (T- wave) that may result in inappropriate inhibition or triggering. If the pacemaker is programmed to dual chamber mode then the refractory periods are independently programmable for atria and ventricle. B. AV Delay The AV delay is the time interval between the two events i.e. An atrial paced or sensed event and the ventricular pacing pulse. AV delay must be selected wisely so that an intrinsic ventricular event occurring within the AV delay will inhibit the ventricular pacing pulse [6].AV delay must not be selected to short or to long so that ventricle event is inhibited. In our pacemaker we have used the Dynamic AV Delay feature. It provides independent selection of AV Delays from five different rate ranges as shown table 1. Table 1: Dynamic AV delay settings Rate Ranges Time delay below 70 bpm 180 ms 70—90 bpm 170 ms 91—110 bpm 160 ms 111—130 bpm 150 ms above 130 bpm 140 ms IV. Modes of pacemaker and features A. VOO VOO mode is used when ventricle chamber is unable to propagate the electrical signal to the purkinje fibres. This mode only pace the ventricles. Each letter in VOO indicates the function processed by heart as per NBG (NASPE/BPEG Generic) code. First letter V indicates that it pace only in ventricles, second letter O indicates that pacemaker does not sense any of the chambers and third letter O indicates that there is no mode of response is used. VOO mode algorithm is shown in the figure 3. Figure 3: VOO mode algorithm Memory AV interval timer Pacing interval timer Microprocessor Telemetry Atrial stimulus generator Atrial sense Ventricular sense Ventricular stimulus generator Data bus To heart Reset counter Increment counter LRI expired? No Yes Deliv er pulse
- 3. Omkar Dwivedi Int. Journal of Engineering Research and Applications www.ijera.com ISSN : 2248-9622, Vol. 5, Issue 5, ( Part -5) May 2015, pp.155-158 www.ijera.com 157 | P a g e B. VVI VVI mode is used for all symptomatic Brady arrhythmias, but particularly if the atrium does not significantly contribute to the hemo-dynamics (persistent or paroxysmal atrial flutter or fibrillation, dilated atria). Thismode only pace and sense the ventricles. Each letter in VVI indicates the function processed by heart as per NBG (NASPE/BPEG Generic) code. First letter V indicates that it pace only in ventricles, second letter v indicates that pacemaker sense the ventricle chamber and third letter I indicates that there is inhibition mode of response is used. VVI mode algorithm is shown in the figure 4. Figure 4: VVI mode algorithm C. AAI The AAI mode is usedforSymptomatic Sino-atrial node dysfunction (sick sinus syndrome. This mode only pace and sense the atrial chamber. Each letter in AAI indicates the function processed by heart as per NBG (NASPE/BPEG Generic) code. First letter A indicates that it pace only in atrial, second letter A indicates that pacemaker sense the atrial chamber and third letter I indicates that there is inhibition mode of response is used. D. DDD The DDD mode is used for AV synchrony is needed over a wide range of rates, suchas active or young patients with an adequate increase in atrial rate, and/or significant hemodynamic indication, and/or previous occurrence of pacemaker syndrome or of a reduction in systolic blood pressure of more than 20 mm Hg under ventricular pacing with pulse generator implantation (regardless of any evidence of retrograde VA conduction). Figure 5: DDD mode algorithm This mode pace and sense the both chamber. Each letter in DDD indicates the function processed by heart as per NBG (NASPE/BPEG Generic) code. First letter D indicates that it pace in both chamber, second letter D indicates that pacemaker sense the both chamber and third letter D indicates that there is both inhibition and triggered mode of response is used. V. Problem There are many equipment or devices which may affects the pacemaker such as electric arc welders, electric melting furnaces, radio, TV ,radar transmitters, high voltage transmissions line , electric ignition system, metaldetector and microwave transmitter . VI. Result Figure 6: Simulation result of mode AOO. Reset LRI Reset VRP Incrementcounters Sense? LRI expired? Deliver pulse VRPexpired? Yes Yes Yes No No No AEI expired ? Ventricle sensed ? AVI expired ? Atrium sensed ? Pace atrium Pace v entricle Yes No Yes No Yes No Yes No
- 4. Omkar Dwivedi Int. Journal of Engineering Research and Applications www.ijera.com ISSN : 2248-9622, Vol. 5, Issue 5, ( Part -5) May 2015, pp.155-158 www.ijera.com 158 | P a g e Figure 7: Simulation result of mode VOO. Figure 8: Simulation result of mode DOO. Figure 9: Schematic RTL symbol VII. Conclusion There are many problem which are discussed above that need to be improved such as it need to be made compatible to MRI. Many problem comes in notice during diagnostic process such as over sensing or under sensing. These problem may be solved by selecting correct sensitivity parameter. We need to understand basic pacing terminology and modes to treat patients effectively. VIII. Future scope Due to development in embedded system, clinicians can extract the patient diagnostic history from cardiac pacemaker system. An energy harvesting technique should be developed which can power itself from body i.e. no requirement of battery. References [1] “Prevention of cardiovascular Disease”, NICE public health guidance 25, Issued: June 2010. [2] “Assessing cardiac activity”, Benny Rousso, Rishon-LeZion (IL); EyalLebanony, Haifa (IL); David Prutchi, Voorhees, NJ (US); OphirBitton, Zikhron- Yaakov (IL), Patent N0.:US 8,406,864 B2, Date of Patent: Mar. 26, 2013. [3] “Rate adaptive pacemaker”, Mart Min, Tallinn (EE); Andres Kink, Harjumaa (EE); ToomasParve, Tallinn (EE), Patent No.: US 6,885,892 B1, Date of Patent: Apr. 26, 2005. [4] “Cardiac force sensor and methods of use”, Yongxing Zhang, Irvine, CA (US); YunlongZhangs, Mounds View, MN (US); Xuan Wei, Plymouth, MN (US) Patent No.US 8,417,355 B2,Date of Patent: Apr. 9, 2013. [5] “Temperature sensor for a leadless cardiac pacemaker”, Alan Ostroff, Pleasanton, CA (U S), Patent No.: US 8,543,205 B2, Date of Patent: Sep. 24, 2013. [6] “Reduction of AV delay for treatment of cardiac disease”, Joseph M. Pastore, Concord, OH (US); Rodney W. Salo, Fridley, MN (US); Julio C. Spinelli, Lakewood Ranch, FL (US); Allan C. Shuros, St. Paul, MN (US); Andres Belalcazar, St. Paul, MN (Us) Patent N0.: US 8,311,630 B2, Date of Patent: Nov. 13, 2012.