• Development and evaluation of technologies for enh

FOREWORD Alessandro Sala
This thesis is based upon studies conducted during February 2009 to July 2009 at the Ovesco
Endoscopy AG company and Novineon Healthcare Technology Partners, placed in Tübingen,
Germany. The first one is a medical device company operating in the fields of flexible
endoscopy and endoluminal surgery. This company develops, manufactures and markets
innovative products for the treatment of gastrointestinal disease. The second one is a private
consulting and research company for the healthcare industry that supports manufacturers and
users of medical products and services in all aspects of R&D, product assessment and
marketing.
The scope of this thesis is the development of two different approaches to reach the goal of
tissue excision using instruments with enhanced dexterity and reducing the number and
dimensions of the access ports.
The main requirements for this purpose are:
 Scare-less procedure;
 high control and dexterity of the instrument;
 simplicity of use;
 intuitive movement.
The two systems that will be explained in the next pages are the Bimanual Manipulator and
the Magnetic Retractor System.
My study was particularly focused on the design and development of the Bimanual
Manipulator.
The Bimanual Manipulator exploits two ergonomic handles to perform tissue excision
without any scar in the abdominal wall and by using the visual field of the endoscope and its
working channel to reach the part of the gastrointestinal tract where the operation will be
performed. One handle is used to hold the tissue and the other one to perform resection.

Therefore, it is possible to obtain tissue tension and consequently a directed visualization of
the resection line, making possible to prevent the most common complications.
I chose this project because it seems very promising, by considering the trend of the last years
of focusing surgical research towards instruments capable of performing complex procedures
inside the body, but reducing as much as possible them invasiveness.
There are many operations in which tissue excision is requested, like cholecystectomy,
Endoscopic Mucosa Resection (EMR) or Endoscopic Submucosal Dissection (EDS). In this
thesis the main applications of the Bimanual Manipulator will be identified.
FOREWORD Agnese Sgorbini

This thesis is based on an internship of 6 months (February-July 2009) at Novineon
Healthcare Technology Partners GmbH and Ovesco Endoscopy AG in Germany.
The first one is a consulting company for healthcare industry, whose business is the research
and development of novel medical devices for endoluminal and laparoscopic surgery.
The second one is a medical device company operating in the fields of flexible endoscopy and
endoluminal surgery.
The work in these companies led to the development of two projects with the same target.
The aim is to develop and research new medical devices for the complete removal of organs
or tumoral tissues from the patient’s body in low invasive procedures. These “scar-less”
operations bring many advantages to the patient such as less pain, reduced recovery time and
improved cosmetic outcome; on the other hand, low access ports mean reduced dexterity and
bad visualization of the surgical field.
My effort has been oriented towards the study of magnetic fields and their possible use to
solve these problems. Some research groups have already faced with these topics and the
possibility of a “magnetic retraction” system is becoming a reality.
The main idea is to lift-up the tissue thanks to the attraction force between two approaching
magnets (one placed inside the body and linked with the tissue and the other positioned
outside the patient).
In my opinion the exploitation of magnetic interaction could be very effective to solve these
problem as it provides a “second hand” in the working space without the use of any shaft; the
absence of a direct link leads to a minimal obstruction of the endoscopic or laparoscopic view.
The first part of the work consisted of studying several kinds of magnets and their interaction.
The development and evaluation of a forceps to join the internal magnet and the tissue has
been another crucial point.
After that the optimal system was selected, several evaluations have been done in order to
find out the feasibility and safety of the magnetic system and its possible applications.
The advantages and limits of the magnetic system has been considered and possible future
developments are presented in order to give some suggestions for further study.
At the same time another approach was developed to overcome the limits of low invasive
procedures: a bimanual manipulator for flexible endoscopy. This device exploits a grasper to
lift-up the tissue and a cutting tool to remove it.
This manipulator has been compared with the magnetic system as regards their applications
and the possibility of using them together, combining their features.