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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_605_Библиотеки_им_академика_М_И_Перельмана.pdf
404 Biomedical Engineering in Gastrointestinal Surgery
10.1.1.3 Conclusion and Further Development
Soon after the advent of laparoscopic surgery the idea was born to replace
human camera guidance by dedicated machines. Since then, a broad
range of various solutions has been offered (
Table 10.2).
Despite considerable initial interest of the surgical community, the first
generation of camera guidance systems failed. They were too heavy, too
bulky, and augmented the surgical workload rather than reducing it.
The new generation appears to be more successful since the devices
are more ergonomic and more flexible. A real breakthrough, however, is
only probable if the essential problem of autonomous camera control is
solved. The first approaches of the AutoLap and the SOLOASSIST are
promising.
10.1.2 MasterSlave Systems
The use of so-called “masterslave systems” was the next step in the evolution of “robotic” surgery. These mechatronic support systems should
not be limited to visualization only but really help to do the surgery. The
idea is to perform the necessary surgical manipulations (including camera
steering) by means of teleactors which are positioned close to the patient.
These teleactors translate the movement of the surgeon’s hand into
Table 10.2 Camera guidance systems
System Provider (Still)
commercially
available
AESOP Computer Motion, Inc.,
Goleta, CA, United States
LapMan Medsys, Gembloux, Belgium
EndoAssist/
FreeHand
FIPS Karl Storz GmbH, Tuttlingen,
EVOLAP Universite Catholique de Louvain,
ImagTrac Olympus Optical Co., Tokyo, Japan ?
ViKY Endocontrol Medical, Grenoble,
AutoLap MST Medical Surgery Technologies,
SOLOASSIST Aktormed GmbH, Barbing, Germany 1
EMARO Riverfield, Inc., Tokyo, Japan ?
Prosurgics, High Wycombe, United
Kingdom
Germany
Belgium
France
Yokneam, Israel
1
1
1
Mechatronic Support Systems and Robots
405
appropriate motions of the surgical tools of the “slave.” The surgeon sits
at a computer console apart from the patient at a remote site, being the
“master” of the scenario. One of the first examples was the “Advanced
Robotic Telemanipulator for Minimally Invasive Surgery” (ARTEMIS)
[16]. Clinical application was achieved by the ZEUS and the DaVinci
design.
10.1.2.1 ZEUS
The manufacturers of the AESOP arm (see above), Computer Motion
(Goleta, CA, United States), combined three AESOP arms (see
Section 10.1.1: Active Camera Holders) to create a new telerobotic
“masterslave” unit. The voice-controlled robot AESOP continues to
hold the camera. Two additional AESOP-like arms, also mounted to the
OR table, were modified to control surgical instruments. The surgeon
controlled the instruments by specially designed interfaces (
Fig. 10.19).
The 3D imaging system was provided by Computer Motion (Goleta,
CA, United States). The system eliminated the surgeon’s resting tremor
and was able to scale down the movements of the surgeon’s hand over a
range of 2:110:1
[5]. The 10-mm three-dimensional (3D) telescope was
controlled by voice activation like the AESOP, the surgeon wearing a 3D
goggle.
The ZEUS was, without any doubt, a remarkable concept and was
appreciated by the users who performed cardiothoracic, visceral, and vascular surgery. The ZEUS system was also used for the first transatlantic
Figure 10.19 The ZEUS system: (A) The console in the foreground with the remote
slave in the background; (B) the handpieces of the system resembled joysticks rather
than surgical instruments.
406
Biomedical Engineering in Gastrointestinal Surgery
surgical procedure, when a laparoscopic cholecystectomy was performed in
Strasbourg/France by Jacques Marescaux seated at a console 3800 miles
away in New York/United States (“Operation Lindbergh”)
[17].Some
direct comparisons of the ZEUS and the DaVinci system were published
[1820], demonstrating an almost equal performance of both systems.
However, it vanished from the market when Computer Motion
became part of the Intuitive Surgical conglomerate in 2003.
10.1.2.2 DaVinci
In opposition to the ZEUS design, the three arms of this system (Intuitive
Surgical) are integrated into a separate robotic arms unit (
Fig. 10.20). The
slave unit (patient side cart) is a compact device with four arms.
The surgeon is located in an ergonomically comfortable surgeon con-
sole distant from the patient (
Figs. 10.21 and 10.22).
Comparable to a microscope, the DaVinci system offers a very
stable 3D visualization system since the head (and the eyes) of the surgeon
are in a steady position to the binoculars. The camera is held by one of
the arms and is controlled by the surgeon providing a stable image of the
surgical site.
Another remarkable feature is the design of the surgical instruments.
It is an essential limitation of laparoscopic surgery that rigid instruments—
inserted thr ou gh the in variant point of the trocar—have to be used. DaVinci
enlarges the number of degrees of freedom at the tip of the instrument by
additional articulations (the so-called endowrist) (
Fig. 10.23).
Figure 10.20 The “slave” part of the DaVinci: (A) Patient side cart. Four arms are pro-
vided. During use, they are covered by sterile drapes. (B) Detailed view of the arms.
From Intuitive Surgical.
Mechatronic Support Systems and Robots
Figure 10.21 (A) The “master” control component of the system; (B) highly magni-
fied 3D HD vision ensures that surgeons can see the surgical site with true depth
perception and crystal-clear vision while the surgeon’s head is positioned in the console on a cushion. From Intuitive Surgical.
407
Figure 10.22 Control of the “slave”: (A) For manipulation of the instruments, the sur-
geon’s hand is positioned at the master controllers for intuitive control over the
instruments; (B) foot pedals for electrosurgery, the “clutch,” and camera and instrument control. From Intuitive Surgical.
Thus, they offer seven degrees of freedom and 90˚ of articulation
which improves versatility enormously as compared to standard laparoscopic instruments. The range of instruments available is impressive: more
than 40 different instruments including graspers, forceps, scissors, clip
appliers, and needle drivers in various sizes and shapes.
408
Biomedical Engineering in Gastrointestinal Surgery
Figure 10.23 (A) Surgical manipulator; (B) the endowrist functionality: the design
was clearly inspired by the function of the human hand. From Intuitive Surgical.
Even more impressive is the successful adaptation of advanced energy
instruments.
Advanced technology with vessel sealing capabilities and cutting function in combination with fully wristed instrument tips (endowrist) are
available as well as stapling devices.
The principle of ultrasound dissection (see Section 6.3: Ultrasound
Dissection) is available as the DaVinci Harmonic ACE, and impedancecontrolled electrocoagulation (see Section 6.2.12.1: Impedance-Controlled
Electrocoagulation) as the DaVinci PK dissecting forceps.
It is a common problem of all mechatronic support systems to find
the optimal position relative to the target area. The DaVinci Xi System
considerably facilitates this process by a laser navigation which is integrated into the boom (
Fig. 10.24).
In Chapter 14, Visceral Surgery of the Future: Prospects and Needs,
the visions of a so-called “cognitive surgical environment” are developed.
Aspects like this one—optimized positioning of “intelligent” mechatronic
support systems—are an important piece of the mosaic.
Whenever nontable-mounted systems are used in a surgery, the position of the OR table cannot be modified any longer after initial calibration of the table and the device.
This was initially true for older versions of the DaVinci system. The
latest technology, the DaVinci Xi System, can be equipped with an integrated table motion allowing an intelligent communication between the
support system and the OR table (
Fig. 10.25).
Mechatronic Support Systems and Robots
409
Figure 10.24 A laser targeting system facilitates the optimal positioning of the cart.
Once the scope is attached, it has simply to be pointed at the target anatomy and
the system will position the boom in an optimized configuration for the procedure.
From Intuitive Surgical.
Figure 10.25 The concept of “integrate d table motion.” The idea is to connect the
DaVinci Xi Surgical system to TRUMPF Medical’s TruSystem 7000dV Operating Table. The
patient can be dynamically positioned while the surgeon operates. From Intuitive Surgical.
410
Biomedical Engineering in Gastrointestinal Surgery
Figure 10.26 Indocyanine green fluorescence: If injected into the bloodstream, the
dye is conjugated to albumin and secreted via the bile duct system. After excitation
with a wave length of 803 mm, the bile duct system becomes visible. From Intuitive
Surgical.
Changing the position of the patient is extremely helpful in many
surgical procedures (e.g., colorectal surgery). If the position is fixed, the
procedure becomes time-consuming and difficult. Integrated
table motion enables the surgeon to switch to the optimal positioning
anytime during the intervention, which makes surgery faster and safer.
One of the latest innovations concerns the improvement of visualization and anatomical orientation, the DaVinci Xi system now has integrated fluorescence imaging capabilities which facilitate the intraoperative
identification of some characteristic landmarks, like the bile duct
(
Fig. 10.26).
Since indocyanine green is excreted in the bile, it will soon appear in
the common bile duct and illuminate it with the specific wave length
used. Similarly, the dye appears in urine making the renal hilum visible
(
Fig. 10.27).
As already briefly mentione d in Section 7.4: Mono-Port (Single Port)
Surgery, a mono-port model of the DaVinci is also already available.
NOTES protagonists are ev en waiting for an adaptation for scarless surgery.
Continuous extensions of the DaVinci system can certainly be
expected. Most probably, it will even become a good fundament for a
cognitive and cooperative support platform (see Chapter 14: Visceral
Surgery of the Future: Prospects and Needs).
Critical Aspects
Today, the DaVinci has become more or less a synonym of “surgical
robot.” It is little wonder that it is also prototypically used for discussing
critical aspects of “robotic surgery.”
A permanent matter of debate are the surgical manipulations, just to
take one example.
Mechatronic Support Systems and Robots
411
Figure 10.27 (A) Normal laparoscopic view of the renal hilum; (B) activation of fluorescence: parenchymal perfusion and the pelvis can be assessed. From Intuitive
Surgical.
This complicated mechanical design could cause, however, problems in
hygienic regards. The tip is activated by traction wire and the mechanical
design is complex. Accordingly, cleansing and reliable resterilizing offer
many problems. A disposable design could avoid these problems, but so far,
the instruments are far too expensive for single use. Intuitive Surgical chose
a compromise: after ten activation cycles, the instruments are deactivated,
which appears to be the best trade-off between the strict rules of reprocessing on the one hand and economy on the other one. Beyond that, any
complex mechatronic system in surgery is, at least theoretically, prone to
immanent safety risks. Only recently, a first systematic retrospective analysis
of adverse events in robotic surgery (almost exclusively focused on the
DaVinci) was published. This study was based upon the publicly available
MAUDE database of the FDA. During the study period (200013), 144
deaths (1.4% of the 10,624 reports), 1391 patient injuries (13.1%), and
8061 device malfunctions (75.9%) were reported. The authors found out
412 Biomedical Engineering in Gastrointestinal Surgery
that the numbers of injury and death events per procedure have stayed relatively constant [mean 5 83.4, 95% confidence interval (CI): 74.292.7 per
100,000 procedures] over the years. Surgical specialties for which robots
are extensively used, such as gynecology and urology, had lower numbers
of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 versus 232.9 per
100,000 procedures, Risk Ratio 5 2.2, 95% CI: 1.92.6). Device and
instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%),
unintended operation of instruments (8.6%), system errors (5%), and
video/imaging problems (2.6%), constituted a major part of the reports.
Device malfunctions impacted patients in terms of injuries or procedure
interruptions. In 1104 (10.4%) of all the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to nonrobotic
techniques (7.3%), or to reschedule it (2.5%)
[21].
All of us are aware of the fact that nothing in life is obtained for free.
Almost any innovation in surgery does not only lead to improvements
but is also always accompanied by specifically new, immanent risk. The
riskbenefit ratio is essential. Unfortunately, in visceral surgery it is still
not yet clear—even after about 15 years—whether currently available
masterslave system operations are really superior to laparoscopic or open
surgeries. Meanwhile, a wealth of scientific papers and meta-analyses has
been published upon this topic. For low or medium routine level surgeries, the masterslave systems do not offer advantages and are, by far, too
expensive. The question is whether they might be helpful in more
advanced procedures such as esophageal, hepatobiliary, pancreatic, or
colorectal interventions. After many meta-analyses, the picture is not yet
clear
[2229]. A recent safety and effectiveness analysis concluded:
“Gastrointestinal surgery with the da Vinci Surgical System is safe and
comparable, but not superior to standard laparoscopic approaches.
Although clinically acceptable, its use may be costly for select gastrointestinal procedure. Current data are limited to the da Vinci Surgical System;
further analyses are needed”
[30].
10.1.2.3 New Developments
The current monopoly of the DaVinci system does not only preserve a
relatively high cost level, but it also impairs further progress of development. Fortunately, some independent international competitors have
arisen to make the market broader.
Mechatronic Support Systems and Robots
10.1.2.3.1 Titan SPORT
413
Titan Medical, Inc., Ontario, Canada, announced the AMADEUS surgical robot almost six years ago, but up to now, nothing has been heard
about clinical evaluation.
Instead, Titan now propagates the SPORT (single port orifice robotic
technology) surgical system for laparoscopic single- and multiquadrant
surgeries. A preview model was unveiled at the beginning of 2016. Little
is known about the system up to now, but it is said that it resembles the
next generation DaVinci SP system that Intuitive Surgical is developing
now. SPORT consists of two components: the surgical workstation
(
Fig. 10.28) and the Patient Car t and Camera Insertion Tube (CIT)
(
Fig. 10.29) [31].
Figure 10.28 Surgical workstation of the SPORT: Ergonomic open workstation with
HD flat-screen 3D monitor. Innovative hand controllers and state-of-the-art
adjustable elbow controls contribute to optimal ergonomy. From Titan Medical, Inc.