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Textbook Bioengineering For Surgery The Critical Engineer Surgeon Interface 1St Edition Drake Ebook All Chapter PDF
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Bioengineering
for Surgery
This page intentionally left blank
Woodhead Publishing Series in
Biomedicine: Number 84
Bioengineering
for Surgery
The Critical Engineer-Surgeon Interface
Edited by
This book and the individual contributions contained in it are protected under copyright
by the Publisher (other than as may be noted herein).
Notices
Knowledge and best practice in this field are constantly changing. As new research and
experience broaden our understanding, changes in research methods, professional
practices, or medical treatment may become necessary.
Practitioners and researchers must always rely on their own experience and knowledge
in evaluating and using any information, methods, compounds, or experiments described
herein. In using such information or methods they should be mindful of their own
safety and the safety of others, including parties for whom they have a professional
responsibility.
To the fullest extent of the law, neither the Publisher nor the authors, contributors, or
editors, assume any liability for any injury and/or damage to persons or property as a
matter of products liability, negligence or otherwise, or from any use or operation of
any methods, products, instructions, or ideas contained in the material herein.
ISBN: 978-0-08-100123-3 (print)
ISBN: 978-0-08-100130-1 (online)
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library
v
vi Contents
ix
x About the Editors
Ayed M. AlQahtani, ME
Ayed M. AlQahtani is a registered mechanical engineer and he received
his BS in mechanical engineering at King Saud University, Riyadh. He is
highly experienced in the field of engineering, facility management,
project management, and operations works. In addition to exposure and
actual hands-on experience in the field of plant engineering in accordance
to Saudi Government policy and regulations, he has also gained knowl-
edge and experience in different areas of work including: general man-
agement, engineering design, facility management, project management,
contracts management, human resources, operation administration, and
supply chain management. Currently, he is working as executive director
of Operation/Strategic Construction Program Director at King Fahad
Medical City and responsible for the implementation of safety mainte-
nance operation compliance to national and international facility man-
agement standards of a safe functional practices at King Fahad Medical
City, ensuring an effective and efficient environment for patients, staff,
and other individuals. He also manages the operational modernized
building construction of the National Neurosciences Institute, Compre-
hensive Cancer Center, Cardiac Center, Proton Therapy Centre,
Cochlear Implant Center, and the laboratories and offices of the Central
Services Building.
Hamidreza Azimian, PhD
Hamid is currently a robotics senior project manager at the Center for
Image-Guided Innovation and Therapeutic Intervention at the Hospital
for Sick Children, Toronto, Ontario, Canada. He received a PhD in me-
chanical engineering from the University of Western Ontario, London,
Ontario, in 2012, an MSc in electrical engineering from K.N. Toosi
University of Technology, Tehran, Iran, in 2006, and a BSc in electronics
engineering from Iran University of Science and Technology, Tehran, Iran,
in 2004. His areas of interests include robotics, mechatronic systems, and
model-based control and optimization. He has published several articles
and is a reviewer for the Control Engineering Practice journal, Journal of Robotic
and Intelligent Systems, IEEE Transactions on Robotics, IEEE International
Conference on Robotics and Automation, and IEEE/RSJ International
Conference on Intelligent Robots and Systems.
xi
xii About the Authors
Georges Azzie, MD
Georges Azzie is a pediatric surgeon at the Hospital for Sick Children,
Toronto, and an associate professor in the Department of Surgery at the
University of Toronto. His scholarly interests revolve around education,
surgical simulation, and global surgery and international health.
Pavan Brahmamdam, MD
Pavan Brahmamdam is a fellow in Pediatric General and Thoracic Surgery at
the Hospital For Sick Children in Toronto, Canada. He obtained his medical
degree from the University of Missouri–Kansas City. He then completed a
general surgery residency at the University of Texas-Southwestern Medical
School. During his residency, he also completed a 2-year National Institutes
of Health–funded research fellowship studying the immunological effects of
sepsis at the Washington University in St. Louis School of Medicine. Before
his fellowship in Toronto, he also completed a surgical critical care fellowship
at Wayne State University and Children’s Hospital of Michigan in Detroit.
His main research interests are in perioperative care, quality improvement,
and the role of simulation in surgical training.
Paolo Campisi, MD
Dr Paolo Campisi joined the Department of Otolaryngology–Head and
Neck Surgery at the Hospital for Sick Children and University of Toronto
in July 2004 and currently holds the rank of associate professor. He earned
his medical degree from the University of Western Ontario and completed
his residency training at McGill University. He then returned to Toronto to
complete a fellowship in pediatric otolaryngology at The Hospital for Sick
Children. Dr Campisi holds a master’s degree in both pharmacology and
otolaryngology and has an interest in disorders of the head and neck, airway,
voice, and saliva management. He is the clinical director of the Center for
Pediatric Voice and Laryngeal Function, a subspecialty clinic designed for
the care of children with voice disorders and the Saliva Management Clinic
at the Holland-Bloorview Children’s Rehabilitation Center. Dr Campisi
served as the director of undergraduate education for the Department of
Otolaryngology–Head and Neck Surgery, University of Toronto, from
2005 to 2012 and as the Pediatric Otolaryngology Fellowship Director from
2007 to 2012. In July 2012, he was appointed the director of postgraduate
education for the Department of Otolaryngology–Head and Neck Surgery,
University of Toronto. In 2015, he was appointed vice chair of education.
He has a strong interest in medical education and has worked with Dr Vito
Forte in the development of an otoscopy simulator.
About the Authors xiii
Rano Matta, MD
Dr Rano Matta completed a bachelor of applied science in chemical en-
gineering at the University of Toronto, with a minor in bioengineering. He
went on to complete a master’s of applied science in biomedical engi-
neering, also at the University of Toronto. His research focused on um-
bilical cord stem cells for bone tissue engineering, completed under the
supervision of Dr John E. Davies. He received his medical training at
Queen’s University School of Medicine. He is now a resident in urologic
surgery at the University of Toronto.
John T. Moore, MA, MSc
John T. Moore received his MA in philosophy from McMaster University,
Hamilton, Ontario, Canada, and his MSc from Western University, London,
Ontario, Canada, in 2005. He is currently a research associate in the image-
guided surgery facility at Imaging Research Laboratories, Robarts Research
Institute, Western University, London, Ontario, Canada.
Terry M. Peters, PhD, FIEEE
Terry M. Peters is a scientist in the Imaging Research Laboratories at the
Robarts Research Institute, London, Ontario, Canada, and professor in the
Departments of Medical Imaging and Medical Biophysics at Western
University London, Canada, as well as a member of the Graduate Programs
in Neurosciences and Biomedical Engineering. He is also an adjunct pro-
fessor at McGill University in Montreal. Dr Peters’ laboratory focusses on
image-guided procedures of the heart, brain, spine, and abdomen. He has
authored two books, more than 270 peer-reviewed papers and book
chapters, and has mentored more than 85 trainees at the master’s, doctoral,
and postdoctoral levels.
Nikoo R. Saber, PhD
Nikoo R. Saber is the senior project manager of simulation at the Center
for Image Guided Innovation and Therapeutic Intervention at The Hos-
pital for Sick Children (SickKids) in Toronto, Canada, where she has led
projects in subject-specific laparoscopic surgery simulation, craniofacial
surgery modeling, and surgical tool development. She has also worked on
collaborative projects involving mathematical optimization and robotics in
pediatric cranial vault remodeling, with an aim to transfer the technology to
future operating rooms. Before her appointment at SickKids, Dr Saber
was a postdoctoral scholar at the California Institute of Technology, with
joint appointments at the Huntington Medical Research Institutes and
Children’s Hospital Los Angeles, with her research mainly focusing on
About the Authors xvii
planning platform for head and neck patients receiving both radiation and
surgery. Building on his previous work on PDT planning, he is using tools
developed within the University Health Network Guided Therapeutics
program and his experience in radiation physics to apply the same quality
measures used in radiation therapy for ablative therapies using nonionizing
radiation. His mix of clinical activities and basic research has given
Dr Weersink the perspective and experience to deliver basic research ac-
tivities into useful medical devices that will have an impact on patient care.
PREFACE
xix
xx Preface
Our gratitude extends to all of the people who wrote and contributed to
the chapters collected within this book. Considering that the concept and
idea behind the book is new and somewhat risky, we begin with a heartfelt
thanks to the engineers and students at the Center for Image Guided
Innovation and Therapeutic Intervention (CIGITI) at the Hospital for Sick
Children for their support.
Lisa Abreu deserves a special note of appreciation for her efforts on our
behalf. Lisa found innovative ways for us to meet our deadlines.
Thanks to the Chandos editors at the Kidlington (UK) office of Elsevier,
Harriet Clayton and Glyn Jones; the production manager at Woodhead
Publishing, Omer Mukthar; and the project manager at TNQ Books and
Journals, Jayanthi Bhaskar.
As always, we are grateful to our families and kids for their patience and
encouragement.
xxi
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CHAPTER 1
specialties, including nursing, pharmacy, and even the patient. For example,
the development of an MRI-guided device could involve a team consisting
of staff members from surgery, radiology, anesthesia, and nursing because
the equipment uses knowledge from different areas to accomplish its goal.
To help with this coordination, the focus of this section is the concept of
systems engineering.
By definition, systems engineering is defined as “interdisciplinary field of
engineering that focuses on how to design and manage complex engi-
neering systems over their life cycles.” Complex systems can range from the
development of vehicles (cars, ships, and airplanes) to manufacturing and
power plants. These systems are often composed of smaller specialized
elements. For example, an airplane consists of wings, fuselage, avionics, and
engines in which each of the elements are combined to create the func-
tionality of the plane. Hence, the role of systems engineering is to focus on
the project as a system rather than as individual elements. As such, the
concept of systems engineering is not necessarily new because it is a
common methodology that solves complex engineering problems, but its
application in medicine is novel. For the purpose of medical technology,
systems engineering is an ideal approach because clinicians have a medical
function that may not be solved by one technology but rather a set of
technologies that performs the desired function. Because the systems en-
gineer is involved in ensuring overall functionality, it is often seen as a
centerpiece of engineering that he or she will interact with the engineering
specialties to determine system feasibility (Figure 1.1). The engineer must
maintain sufficient competency in various areas to have an understanding of
how each of the components will affect the resulting performance.
Commonly, the systems engineer is referred to as the “jack of all trades”
because of the multidisciplinary role.
The definition of system is quite varied, but a common element is that it
focuses on the whole entity, for example: “A system is a construct or
collection of different elements that together produce results not obtainable
by the elements alone. The elements, or parts, can include people, hard-
ware, software, facilities, policies, and documents; that is, all things required
to produce systems-level results. The results include system-level qualities,
properties, characteristics, functions, behavior and performance. The value
added by the system as a whole, beyond that contributed independently by
the parts, is primarily created by the relationship among the parts; that is,
how they are interconnected.” Using this definition, one can identify a
variety of systems within the clinical setting. For example, an MRI device is
4 Bioengineering for Surgery
Software
Manufacturing
engineering
Electrical Test
engineering engineering
Acceptance Operations
review concept
Requirements Requirements
check review gate
and operations where the goal is to test, verify, and validate the actual
hardware/software. After verification and validation, the system is delivered
to the customer and the role of the systems engineer shifts to an “operations
and maintenance” mode in which the engineer will support end-user op-
erations. Throughout this “V-model,” there is an iterative process in each
step between the end-user and engineer to ensure the correct requirements
and definitions are met. Initial concepts and operational procedures may have
been generated with a limited knowledge of the technological limitations
leading to a set of requirements that are not achievable. Naturally, the less
iteration, the faster and less costly a project becomes as changes later in the
implementation would require changes traveling upwards toward the
concept. These upward changes to the requirements may sound minor, but
can cause a performance shift in other subsystems. For example, if one is
designing a light source for an endoscope and realizes that a brighter bulb is
needed, this could impact the overall power required and heat dissipated by
the endoscope, which could result in changes to the electrical and cooling
systems. Thus, it is important to recognize that a system needs to be clearly
defined upfront with as much detail as possible to avoid costly changes and
performance impacts to budget, schedule, and feasibility.
To properly describe a system, the initial step is to develop a set of
requirements: a goal, term, or performance objective that a solution must
meet to be successful. These requirements will dictate what and how a
6 Bioengineering for Surgery
Performance Requirement
a) Operational work envelope
i) The system shall guide and support the anastomosis tool to the surgical worksite as defined in
MDAM20457-ICD.0001, KidsArm to operating room and patient interface control document.
ii) The system shall permit the placement of the anastomosis tool anywhere within a preselected 2 cm3
(according to medical advisor) workspace within the patient.
iii) The system shall permit the orientation of the anastomosis tool within ±90° of the selected
home position in both pitch and yaw to enable access to the surgical site.
system should perform. The list may include both quantitative and quali-
tative measurements, but one needs to be careful when using qualitative
requirements because this could vary from one user to another. Figure 1.3 is
an example of the performance requirements for KidsArm, an autonomous
image-guided anastomosis robot. Initially, this may seem like a very simple
task, but if the requirements are not quantifiable, the process can prove to
be quite challenging because an engineer will not be able to design a
mechanism or actuator without a target value. For example, in the design of
a data acquisition system to record samples, there could be a requirement
that the sampling frequency must be 60 samples per second to properly
record the physical phenomenon. Yet, when this is applied to medicine,
biological interactions may not be quantified as clearly. This is not the fault
of medical research, but rather because of the complexity and heterogeneity
of the underlying biology in which behavior is not typically straightfor-
ward. For example, if one is to design a tool to retract tissue and take a
biopsy sample, an engineer may ask how much force is allowed. What is the
acceptable amount of tissue deformation? Even in reviewing the literature
and case data and interviewing clinicians, it is obvious that the answer is not
clear because for some cases there are no data or range of values available.
Yet, when surgeons operate and interact with the tissue, they are able to
instinctively navigate and manipulate tissue to prevent/minimize injury.
Therein lies the problem: surgeons have a vast amount of knowledge based
on their years of experience and training. As engineers, one must be able to
translate this experience to quantifiable parameters whereby engineering
solutions can be designed to meet the goals.
If we return to our design of retractor and biopsy, the question of
allowable force and deformation may be found in the literature, but more
than often it will require a separate set of experiments to generate these
force requirements. This is not an uncommon task; researchers recognize
the value of characterizing mechanical properties of tissue whereby these
properties would be used as guides to developing surgical tools and robots.
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THE BUILDER.
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