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CHAPTER 23 Designing the NOTES Procedure Room
https://t.me/med1917
Chapter video clip
Video 23.1 “High-tech” design of a dedicated NOTES room.
References
1 Perretta S, Allemann P, Dallemagne B, Marescaux J. Natural
orifi ce transluminal endoscopic surgery (NOTES) for neoplasia
of the chest and mediastinum . Surg Oncol 2009;18:177–80.
2 Willingham FF , Gee DW , Lauwers GY , Brugge WR, Rattner DW .
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3 Cahill RA, Asakuma M, Perretta S, Dallemagne B, Marescaux J.
Gastric lymphatic mapping for sentinel node biopsy by natural
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4 Cahill RA, Asakuma M, Perretta S, et al. Supplementation of
endoscopic submucosal dissection with sentinel node biopsy
performed by natural orifi ce transluminal endoscopic surgery
(NOTES) (with video) . Gastrointest Endosc 2009;69:1152–60.
5 Kalloo A, Kantsevoy SV , Singh VK, et al. Flexible transgastric
peritoneoscopy: a novel approach to diagnostic and therapeutic
interventions in the peritoneal cavity . Gastroenterology 2000;118:
A1039.
6 Rattner D, Kalloo A. ASGE/SAGES Working Group on Natural
Orifi ce Translumenal Endoscopic Surgery. October 2005 . Surg
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7 Khashab MA, Kalloo AN. Natural orifi ce translumenal endo-
scopic surgery . Curr Opin Gastroenterol 2010;26:471–7.
8 Willingham FF , Gee DW , Sylla P, et al. Natural orifi ce versus
conventional laparoscopic distal pancreatectomy in a porcine
model: a randomized, controlled trial . Gastrointest Endosc 2009;70:
740–47.
9 Fritscher -Ravens A, Ghanbari A, Holland C, et al. Beyond
NOTES: randomized controlled study of different methods of
fl exible endoscopic hemostasis of artifi cially induced hemorrhage, via NOTES access to the peritoneal cavity . Endoscopy
2009;41:29–35.
10 von Renteln D, Schmidt A, Vassiliou MC, Gieselmann M, Caca
K. Natural orifi ce transluminal endoscopic surgery gastrotomy
closure with an over -the-endoscope clip: a randomized, controlled porcine study (with videos) . Gastrointest Endosc 2009;70:
732–9.
11 von Renteln D, Vassiliou MC, Rothstein RI. Randomized con-
trolled trial comparing endoscopic clips and over -the-scope clips
for closure of natural orifi ce transluminal endoscopic surgery
gastrotomies. Endoscopy 2009;41:1056–61.
12 Rao GV , Reddy DN, Banerjee R. NOTES: human experience .
Gastrointest Endosc Clin N Am 2008;18:361–70, x.
13 Horgan S, Cullen JP , Talamini MA, et al. Natural orifi ce surgery:
initial clinical experience . Surg Endosc 2009;23:1512–18.
14 Jacobsen GR, Thompson K, Spivack A, et al. Initial experience
with transvaginal incisional hernia repair . Hernia 2010;14:
89–91.
15 Asakuma M, Nomura E, Lee SW , Tanigawa N. Ancillary NOTES
procedures for early stage gastric cancer . Surg Oncol 2009;18:
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16 Zorron R, Goncalves L, Leal D, et al. Transvaginal hybrid natural
orifi ce transluminal endoscopic surgery retroperitoneoscopy –
the fi rst human case report . J Endourol 2010;24(2):233–7.
17 Marks JM, Ponsky JL, Pearl JP , McGee MF . PEG “Rescue”: a
practical NOTES technique . Surg Endosc 2007;21:816–19.
18 Hoffman A, Rahman F, Prengel S, et al. Mini-laparoscopy in the
endoscopy unit: safety and outcomes in over one thousand
patients. World J Gastrointest Endosc 2011;3:6–10.
19 Marasco JA, Marasco RF . Designing the ambulatory endoscopy
center . Gastrointest Endosc Clin N Am 2002;12:185–204, v.
20 Sabnis RB, Mishra S, Sharma R, Desai MR. Preoperative plan-
ning and designing of a fl uorocompatible endourology operating
room. J Endourol 2009;23:1579–85.
21 Giday SA, Magno P, Kalloo AN. NOTES: the future . Gastrointest
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22 Spaun GO, Goers TA , Pierce RA, et al. Use of fl exible endoscopes
for NOTES: sterilization or high -level disinfection? Surg Endosc
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23 Kantsevoy SV . Infection prevention in NOTES . Gastrointest Endosc
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24 Giday SA, Dray X, Magno P, et al. Infection during natural orifi ce
transluminal endoscopic surgery: a randomized, controlled
study in a live porcine model . Gastrointest Endosc 2010;71:
812–16.
25 Eickhoff A, Vetter S, von Renteln D, et al. Effectivity of current
sterility methods for transgastric NOTES procedures: results of a
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26 Pearl JP , Marks JM, Ponsky JL. Hybrid surgery: combined lapar-
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27 Shergill AK, McQuaid KR, Rempel D. Ergonomics and GI endos-
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28 Lee G, Sutton E, Clanton T, Park A. Higher physical workload
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255
24
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Evolution and Future Developments of
Instrument Technology for NOTES
D. Nageshwar Reddy , G. V. Rao, Magnus J. Mansard
Asian Institute of Gastroenterology, Hyderabad, India
Introduction
The history of minimally invasive (also called minimal
access) surgery can be traced back to 1901 when the fi rst
laparoscopy was performed on a dog by George Kelling [1].
The fi rst laparoscopy in humans, performed in 1910, is
attributed to the Swedish surgeon Jacobaeus [2]. Though
laparoscopy was routinely used by gynecologists, it was
viewed with skepticism by general surgeons until 1987,
when a cholecystectomy was performed through very small
incisions using a laparoscope and minimal -access instruments by Dr Phillippe Mouret. Thereafter, interest in the
fi eld and the number of procedures performed laparoscopically spread like wildfi re. There is no question that minimal access surgery has revolutionized the practice of many
surgical disciplines. With the giant technological strides
made in recent years there is a growing public demand for
procedures that leave minimal scars, reduce postoperative
analgesic requirements, and account for shorter lengths of
stay. The drive toward less -invasive procedures, now motivated by both patients and a growing population of surgeons
devoted to a philosophy of a minimal -access surgical
approach, has culminated in the possibility of incisionless
surgery. In natural orifi ce translumenal endoscopic surgery
(NOTES) “scarless” abdominal operations are performed via
fl exible endoscopes passed through a natural orifi ce (mouth,
urethra, anus, etc.) then through an internal incision in the
stomach, vagina, bladder, or colon, thus avoiding any external incisions or scars.
Evolution of the modern endoscope
The word “endoscopy” comes from the Greek Endon, inside
and Skopeo, to look at, and therefore refers to the ability of
a medical practitioner to look inside cavities and viscera.
Several cultures, including the Egyptians, Greeks, Romans,
and Arabs, made attempts to view accessible human body
cavities using a variety of instruments such as spatulas and
specula. The fi rst instrument developed to look into deeper
cavities was probably the rectal speculum; the earliest
mention is found in Hippocrates ’ treatise on fi stula [3]. The
fi rst endoscope came from Bozzini, a German urologist, in
1806 [4]. He used concave mirrors and candlelight to allow
examination of the bladder through a hollow tube and called
his invention the Lichtleiter (light conductor). There was no
question that the examination of a deeply located organ
with poor illumination and keyhole vision had great limitations. Nitze, also a German urologist, improved on Bozzini ’s
work by the addition of an electric light and was the fi rst to
place light inside the organ of interest to aid visualization.
The foremost effective open tube endoscope was designed
by Desormeaux in 1853; he used a lens to concentrate the
light from a kerosene lamp to perform cystoscopy. In 1880
Johann von Mikulicz, working with the instrument maker
Leiter, made the fi rst gastroscope using a system similar to
Nitze’s cystoscope [5]. Endoscopes remained essentially
unchanged for almost 70 years after the time of Mikulicz in
the 1880s. It was in 1930 that Heinrich Lamm, a gynecologist, showed that fi ne threads of glass fi bers could be bundled
together to act as a conduit for a light source, and that the
bundles could be fl exed or bent without losing transmission.
When the concept of fi ber optics was applied to endoscopic
instruments, the era of modern endoscopy began. H. H.
Hopkins and van Heel, publishing in the same scientifi c
journal ( Nature), described the fi rst fl exible optical system
[6]. Basil Hirschowitz was the fi rst to apply this new technology in a clinical setting [7]. In February 1957, he passed a
prototype instrument down his own esophagus, and a few
days later he performed the fi rst fi ber optic gastroscopy on
a patient. In the 1960s, a series of modifi cations by American
Natural Orifi ce Translumenal Endoscopic Surgery (NOTES): Textbook and Video Atlas, First Edition. Edited by Anthony N. Kalloo, Jacques Marescaux,
Ricardo Zorron.
© 2012 John Wiley & Sons, Ltd. Published 2012 by John Wiley & Sons, Ltd.
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CHAPTER 24 Evolution and Future Developments of Instrument Technology for NOTES
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and Japanese instrument makers introduced defl ection
control, which allowed the scope tip to be manipulated in
four planes and provided separate channels for suction and
the introduction of water and air. Starting in the early 1990s,
fi ber optic imaging was rendered largely redundant by
“video chip ” endoscopes with charge coupled device (CCD)
sensors. The fl exible endoscope has undergone further engineering and technological advances, resulting in the modern
endoscopes packed with a wide range of essential components within them to revolutionize endoscopy for foregut,
biliary, colonic, and bronchial diseases [8].
Flexible instruments as peritoneoscopes
Most gastroenterologists and surgeons who perform NOTES
procedures are using unmodifi ed double -channel gastroscopes, which may be passed through the wall of the
stomach, rectum, or vagina, or even the esophagus. These
endoscopes, though well suited for endolumenal diagnostics
and for basic procedures such as biopsy, dilation, and
ablations, are not designed for peritoneoscopy. There are
some features that are intrinsic to the present design of fl exible endoscopes that make them diffi cult to use for some
intraperitoneal endosurgery and peritoneoscopy, especially
for those who are used to performing rigid laparoscopy
(Figure 24.1).
When compared with optimal laparoscopic images, their
illumination is inferior, especially when the tip is distant
from the target; two -point visual discrimination is inferior
even when the tip to target distance is optimized. Unlike in
laparoscopy, the image is shifting permanently because the
endoscope is moving. Fixed visual horizons force the surgeon
to adjust to tilted or inverted views. The endoscopes and
instruments are too fl exible for complex intra -abdominal
surgery and cannot provide robust grasping and retraction.
Traction and counter -traction maneuvers are diffi cult. The
fl oppy nature of the gastroscope, with limited control over
the bending section at the tip, results in easy disorientation
during procedures. Furthermore, spatial orientation could
be impaired due to the possibility of performing tasks off the
angle of the scope axis.
Flexible instruments passed through the accessory channel
of a fl exible endoscope are frail. They are ineffective in performing surgical tasks as the push forces that can be exerted
at fl exible endoscopy are generally less than 100 g. It is not
usually possible to completely rotate a fl exible instrument
in the channel of a fl exible endoscope. Flexible endoscopic
forceps are surprisingly poor at grasping tissue and commonly release tissue poorly when opened. The force limitation associated with fl exible endoscopy means that blunt
dissection – a basic and fairly safe surgical practice – is diffi cult, although experience with endoscopic submucosal dissection (ESD) and per -oral endoscopic myotomy (POEM)
(a)
(c)
(b)
Figure 24.1 Design limitations of current fl exible endoscopes.
(a) User -interface too basic to allow easy maneuverability. (b) Deployment
shaft too fl exible and therefore prone to looping. (c) Flexible
instrumentation prone to tip buckling at site of force exertion inside the
peritoneum. (Reprinted from A. Forgione. In vivo microrobots for natural
orifi ce transluminal surgery. Current status and future perspectives. Surg
Oncol 2009; 18:121–9 with permission from Elsevier.)
has overcome this hurdle. Flexible endoscopic scissors can
cut thread but are less effective at cutting tissue.
Evolution of NOTES
Although still in its infancy, the early development of NOTES
has differed in a number of key ways from that of conventional laparoscopy. Laparoscopy was developed by a few
surgeons in a non -formalized way, and was adopted into
practice quickly, despite lack of training and evidence. These
factors resulted in unacceptably high complication rates,
such as with bile duct injuries after laparoscopic cholecystectomy. Senior leadership from the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society of
American Gastrointestinal and Endoscopic Surgeons
(SAGES) organized a working group of surgeons and gastroenterologists in 2006 to develop standards for the practice
of this emerging technique. This group is known as the
Natural Orifi ce Surgery Consortium for Assessment and
Research (NOSCAR) [9]. Their meetings represented a
unique congregation of surgical and therapeutic endoscopists, and a major part of these proceedings were workshops conducted to identify and prioritize the requirements
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SECTION 3 Perspectives on NOTES
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for new technology to enable the clinical application of
NOTES. A White Paper on NOTES was released by NOSCAR
simultaneously in two medical journals in May 2006 [10,11].
This paper identifi ed the major areas of research that needed
to be addressed before NOTES could become a viable clinical
application for human patients. Potential barriers to clinical
practice with NOTES methodology include the following:
1 Access to peritoneal cavity
2 Gastric (intestinal) closure
3 Prevention of infection
4 Development of suturing device
5 Development of anastomotic (nonsuturing device)
6 Spatial orientation
7 Development of a multitasking platform to accomplish
procedures
8 Control of intraperitoneal hemorrhage
9 Management of iatrogenic intraperitoneal complications
10 Physiologic untoward events
11 Compression syndromes
12 Training other providers.
Figure 24.2 Prototype forward -viewing echoendoscope. (Reprinted
from [12] B. Joseph Elmunzer, Steve J. Schomisch, Joseph A. Trunzo,
et al. EUS in localizing safe alternate access sites for natural orifi ce
transluminal endoscopic surgery: initial experience in a porcine model.
Gastrointest Endosc 2009; 69:108–114 with permission from Elsevier.)
Overcoming technical barriers
A unique feature of NOTES is the early involvement of
industry in device development. Unlike laparoscopic surgery,
industry has taken a very early interest in the NOTES
approach, recognizing its potential for widespread application. Some argue that the greatest benefi t of the current
enthusiasm for NOTES is that it will lead to the development
of better instrumentation, which will benefi t fl exible endoscopists and surgeons using rigid endosurgical equipment
both in NOTES as well as in more conventional practice.
Perhaps the most important unique feature of NOTES development is the collaborative effort between surgeons and
gastroenterologists (therapeutic endoscopists). It should be
noted that eight of the barriers identifi ed by NOSCAR are
technical in nature. Signifi cant research and development
has gone into overcoming these barriers by industry. In the
following section we will review the technical developments
formulated during the subsequent years in overcoming
some of these hurdles for NOTES.
Access to peritoneal cavity
Transgastric access into the peritoneal cavity has so far been
performed with the conventional accessories of the routine
endoscopes. Either the needle -knife used in endoscopic retrograde cholangiopancreatography (ERCP) or a sphincterotome has been used to create the enterotomy. Controlled
radial expansion of the gastrotomy puncture is performed
using balloons when the needle -knife is used. Other endoscopic accessories have been used in various combinations
when a submucosal tunnel is created to allow easier and
more reliable closure of the access point in the self approximating translumenal access technique.
There is some anxiety about the safety of blind puncture
of the stomach, rectum, bladder, and vagina. Blind NOTES
access approaches can be associated with colonic and small
intestinal thermal injuries. The optimal location for a secure
introduction of the instrument into the abdominal cavity is
hard to fi nd. To visualize the vessels on the reverse side of
the hollow organ or other organs behind the planned incision site and hence reduce the risk of lacerations would be
a great improvement. This anxiety has led to most human
transgastric and transvaginal cases being performed with
hybrid needlescope or under laparoscopic visualization.
With the recent development of a prototype forward -viewing
echoendoscope (Figure 24.2), endoscopic ultrasound - (EUS)
guided access and closure can be performed anywhere in the
gastrointestinal tract, and the same endoscope used for the
intraperitoneal procedure [12]. EUS provides real -time anatomic information that can be used to select a safe, procedure appropriate NOTES access site [13]. However, use of EUS in
animal and human experiments for locating the access point
has been found to be cumbersome, not user -friendly. Air
interference was found to be a major hurdle and hydroperitoneum has been experimented with successfully in a feasibility study [14].
Overtubes (re -entry sheaths) are useful for multiple intubations using fl exible endoscopes, and some have been used
in experimental and clinical NOTES cases [15]. Overtubes
are intended to protect the gastrointestinal mucosa from
trauma and limit the risk of aspiration. All overtubes are
made of semi -rigid plastic with a tapered, soft, distal tip.
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CHAPTER 24 Evolution and Future Developments of Instrument Technology for NOTES
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They usually feature wirewound coils to prevent kinking.
Some feature soft introduction pieces, inner sleeves with
tapered components to prevent tissue, especially at the
cricopharyngeal junction, from catching between the endoscope and overtube during introduction, and valves to
prevent air from escaping. Overtubes have expanded from
their role as simple endoscopic accessories to more complex
and specialized designs that facilitate endoscope insertion
and bowel wall manipulation. The most commonly reported
complications during overtube use are mucosal abrasions
and tears due to the large diameter of the overtube or pinching of mucosa between the endoscope and overtube [16].
Closure, hemostatic, anastomotic, and
suturing devices
Closure of the transvaginal puncture is easy; transvaginal
peritoneal access and vaginal closure techniques have long
been established in the gynecological community. Transgastric procedures are hindered by lack of a simple method to
close the gastrotomy. Though investigators have performed
experiments in survival animal models without gastric
closure at all, without the development of peritonitis or
sepsis, a foolproof gastrotomy closure remains the sine qua
non for the performance of NOTES in humans. Based on
experience from open and laparoscopic surgery, gastrotomy
closure would seem to be a relatively simple task, especially
in healthy non -diseased stomach. It has, however, proved
to be a very challenging task when performed endoscopically, both from a technologic as well as a surgical skill
standpoint. A variety of devices have been designed and
used for gastrotomy closure. They can be classifi ed into clips,
suturing devices, stapling devices, and occluders [17]. These
devices have also been used in performance of various other
tasks inside the peritoneum, like hemostasis, anastomosis,
and suturing.
Clipping systems
Endoclips
Clips were developed for fl exible endoscopic use in 1971 by
Olympus Corporation (Tokyo, Japan) for the primary
purpose of achieving hemostasis of focal gastrointestinal
bleeding [18]. These “endoclips” or “hemoclips” are available as both reusable and preloaded single -use devices. These
devices have been used in NOTES procedures for various
purposes, including gastrotomy closure, hemostasis, and
clipping of cystic artery and cystic duct, among others.
Closure was obtained by applying clips fi rst to both ends of
the incision and then sequentially toward the center of the
incision [19]. These fl exible clips did not completely coapt
together when closed and in consequence were not necessarily effective if applied to a bleeding vessel in the peritoneal cavity. There remains some uncertainty whether these
fl exibly delivered clips are effective enough for cystic duct
and cystic artery closure when applied during a NOTES
cholecystectomy, and most surgeons have preferred to use
laparoscopic clips that close completely in hybrid procedures
or to use loops or ties.
Recently, there have been further developments in fl exible endoscopic clip design. The TriClip (Cook Endoscopy,
Inc., Winston -Salem, NC, USA) delivers a three -pronged
stainless steel clip that may be applied to deeper structures
than Olympus clips, including the submucosa and deep
muscle. A third single -use, preloaded clipping device (Resolution Clip, Boston Scientifi c Corporation, Natick, MA, USA)
harbors a two -pronged stainless steel clip that tapers from
1.9 mm to 1.2 mm in width from base to tip [18]. A unique
feature of the Resolution Clip is the ability to reopen and
reposition the clip after closing, up to fi ve times as long as
the device has not been fi red. A fourth endoscopic clip
(Multi-Clip, InScope Inc., a Division of Ethicon Endosurgery,
Cincinnati, Ohio, USA) can apply four clips sequentially
without the need for removal and reloading. This device
departs from prior clip designs with mechanisms akin to
laparoscopic devices that grasp the tissue with apposing arms
of a forceps before clip application. The clips can also be
rotated, closed, reopened, and repositioned for optimal
application.
Clips using endoscopic clip appliers have been used for
gastrotomy closure, because they appear to be effective and
safe in closing inadvertent gastric perforations in the
stomach, esophagus, and colon in reports, especially from
Japanese endoscopists who were undertaking endoscopic
mucosal resection. However, most of the clipping devices
enable only a single -layer tissue approximation resulting in
only mucosal coaptation and are hence inadequate for a
full-thickness closure. Mucosal closure alone is likely to
have an unacceptable failure rate because of the low collagen content of this layer and its high cellular turnover. Poor
healing of endolumenally placed mucosal sutures has been
documented experimentally. Taken together, there is room
for better clipping devices for fl exible endoscopy and NOTES.
Over -the-scope clips
The over -the-scope clips (OTSC) system represents a new
generation of nitinol endoscopic clips that provide signifi cantly more strength and better tissue capture compared to
conventional endoclips [20] (Figure 24.3). The OTSC system
for NOTES consists of an enlarged OTSC clip with dentate
spikes to allow an even better grip of the tissue and ancillary
instrumentation to facilitate the approximation of the
wound margins of translumenal access holes [21]. A novel
twin-grasper can be used to facilitate the approximation of
the tissue in NOTES. The OTCS clip is delivered by means
of an applicator cap mounted to the tip of the endoscope.
The enterotomy is identifi ed and once in position, suction is
applied and the OTSC clip is deployed. Once released from
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Figure 24.3 OTSC system. Application device mounted onto the tip of
the gastroscope. (Reprinted from Thomas Kratt, Markus K üper, Frank
Traub, et al. Feasibility study for secure closure of natural orifi ce
transluminal endoscopic surgery gastrotomies by using over -the-scope
clips. Gastrointest Endosc 2008; 68:993–6 with permission from Elsevier.)
Figure 24.5 Padlock-G clip. Once deployed, the nitinol clip (which is
deformed to fi t the cap) recovers its habitual shape, approaching and
tightening the grasped tissues. (Reprinted from Carlos Guarner -Argente,
Henry C órdova, Graciela Mart ínez-Pallí et al. Yes, we can: reliable colonic
closure with the Padlock -G clip in a survival porcine study (with video).
Gastrointest Endosc 2010; 72:841–4 with permission from Elsevier.)
Figure 24.4 Endoscopic view immediately after suffi cient OTSC closure.
(Reprinted from Thomas Kratt, Markus K üper, Frank Traub, et al.
Feasibility study for secure closure of natural orifi ce transluminal
endoscopic surgery gastrotomies by using over -the-scope clips.
Gastrointest Endosc 2008; 68:993–6 with permission from Elsevier.)
the cap, the OTSC returns to its original closed shape due to
the super -elastic properties of the material, thus securely
compressing the target tissue (Figure 24.4).
Padlock-G clip
The Padlock -G is another nitinol clip that is six -sided and
has six inner prongs that embed into the gastric wall around
the gastrotomy site (Figure 24.5). It comes with a deployment pod (Lock -It system) [22]. This locking device can be
folded before deployment. When the device is deployed it
snaps back into its original fl at or disc -like shape. The six
prongs gather the edges of the gastrotomy into a secure,
watertight bundle, similar to a purse string closure, thus
sealing the gastrotomy (Figure 24.6).
Stitching systems
T-tags
T-tags have been used to close perforations in clinical cases.
The same technique can be translated into gastrotomy
closure. A series of double tags are positioned in a relatively
easy way around the defect, through the wall, to be then
approximated in pairs, and locked at the same time by
various locking mechanisms [23]. The disadvantage of this
technique is the risk of inadvertent puncture of surrounding
organs. They also necessitate multiple passes and repositioning of the endoscope, which is time consuming.
Flexible Endo Stitch
The fl exible Endo Stitch (Covidien, North Haven, CT, USA)
is another device described for gastric defect closure [24]. It
has two jaws. A sutured Endo Stitch needle, loaded from a
single-use loading unit, is held in one jaw and can be passed
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to the other jaw by closing the handles and fl ipping the
toggle levers. Its large diameter and diffi culty in maneuverability raise some doubt about its ease of use in the clinical
setting.
Loop-anchor purse-string closure system
The loop -anchor purse -string (LAPS) closure system is a
modifi cation in which T -anchors with attached metal loops
provide a transmural, purse -string closure [25,26] (Figure
24.7). The anchors are placed transmurally from within the
stomach by using a 19 gauge endoscopic needle with a slot
near the tip to allow passage of the wire loop. The anchors
are then pushed out of the slotted needle by using an inner
stylet. Four such anchors are placed sequentially, on the
same suture around the gastrotomy (Figure 24.8). The gastrotomies are then closed transesophageally by pulling on
the free ends of the suture through a pushing catheter and
securing the tie with a friction -fi t collar and a crimping
device (Wilson -Cook). During this maneuver, the nylon
suture slides through the loops, effectively drawing them
inward to form a purse -string closure.
LSI Purse String Suturing
Another device, named Purse String Suturing (LSI Solutions, Victor, NY, USA), has been described by the group of
Thompson [27]. This is a device consisting of a large chamber
in which the tissue containing the defect to be closed is
aspirated, obtaining an invagination of the tissue (Figure
24.9). Two needles are then advanced through the tissue,
creating a sort of purse string, which is then closed. The
system proved effective, in an average time of 3 min, in
closing both a transgastric and transcolonic approach. A
single case of fallopian tube adhesion was reported.
Figure 24.6 Endoscopic view of a Padlock -G clip (Aponos Medical,
Kingston, NH, USA) deployed: a pseudopolyp is created that contains the
incision in the center. (Reprinted from Carlos Guarner -Argente, Henry
Córdova, Graciela Mart ínez-Pallí et al. Yes, we can: reliable colonic closure
with the Padlock -G clip in a survival porcine study (with video).
Gastrointest Endosc 2010; 72:841–4 with permission from Elsevier.)
Device is 7 mm
× 0.81 mm
Eagle Claw
The Eagle Claw, developed in collaboration between the
Apollo Group and Olympus, is a simple grasping and needle driving device that fi ts on the end of a standard endoscope
[28,29] (Figure 24.10). It is capable of grasping large amounts
Figure 24.7 T-fastener with metal loop and suture. This allows full -thickness placement of any number of fasteners on a single suture. The photograph
is an endoscopic view of a single fastener placed transmurally in an explanted porcine stomach. (Reprinted from [26] David J. Desilets, John R. Romanelli,
David B. Earle, et al. Loop -anchor purse -string versus endoscopic clips for gastric closure: a natural orifi ce transluminal endoscopic surgery comparison
study using burst pressures. Gastrointest Endosc 2009; 70:1225–30 with permission from Elsevier.)
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Figure 24.8 Simplifi ed drawing, endoscopic view, and cutaway view of four transmural T -fasteners arranged in a square pattern just prior to closure of
gastrotomy. (Reprinted from [26] David J. Desilets, John R. Romanelli, David B. Earle, et al. Loop -anchor purse -string versus endoscopic clips for gastric
closure: a natural orifi ce transluminal endoscopic surgery comparison study using burst pressures. Gastrointest Endosc 2009; 70:1225–30 with permission
from Elsevier.)
Figure 24.9 LSI Solutions prototype devices. (Reprinted from [27]
Marvin M. Ryou, Derek G. Fong, Reina D. Pai, et al. Evaluation of a novel
access and closure device for NOTES applications: a transcolonic survival
study in the porcine model (with video). Gastrointest Endosc
2008;67:964–9 with permission from Elsevier.)
of tissue and taking substantial bites with the needle. The
Eagle Claw uses large curved needles and allows suturing
under direct endoscopic vision. The needle delivers a pre tied monofi lament suture with a sliding lock that can be
cinched down with a separate device. The introduction of
an opposable jaw allows the new suturing device to suffi ciently grasp the tissue to achieve full -thickness sutures. The
grasping forceps function also allows placing sutures more
precisely. The device uses a suture -locking device to tie
together and lock the thread. On opposing the jaws, the
device is able to appose the tissue under direct endoscopic
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Figure 24.10 Schematic illustration of the suturing process with the
Eagle Claw II. (Reprinted from Bing Hu, S. C. Sydney Chung, Lawrence C.
L. Sun, et al. Eagle Claw II: a novel endosuture device that uses a curved
needle for major arterial bleeding: a bench study. Gastrointestinal Endosc
2005;62:266–70 with permission from Elsevier.)
vision. After passing through the tissue, the needle is
detached and trapped by a plastic casing. The plication is
completed on tightening of the suture to appose the plastic
casing to the mucosa. The device has been updated with the
latest version, Eagle Claw VII, consisting of a mounted 3 -O
nylon stitch with a detachable needle attached to a curve
holder [30] (Figures 24.11 and 24.12]. Further, the size of
the device has been reduced and the operation of the handle
simplifi ed compared with the original prototype. The movements of the needle, the catching cartridge, and the release
of the thread were controlled by a handle operated sepa-
CHAPTER 24 Evolution and Future Developments of Instrument Technology for NOTES
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Figure 24.11 The Eagle Claw VII endoscopic suturing device. (Reprinted
from [30] Philip W. Chiu, James Y. Lau, Enders K. Ng, et al. Closure of a
gastrotomy after transgastric tubal ligation by using the Eagle Claw VII: a
survival experiment in a porcine model (with video). Gastrointest Endosc
2008;68:554–559 with permission from Elsevier.)
Figure 24.13 g-Prox tissue grasper and approximator device by USGI
Medical, San Clemente, CA, USA. (Reprinted from M. Al -Akash, E. Boyle,
W. A. Tanner. NOTES: the progression of a novel and emerging
technique. Surg Oncol 2009; 18:95–103 with permission from Elsevier.)
of the Eagle Claw capable of deploying multiple running and
interrupted stitches with a single insertion of the endoscope.
The unique design of this scope mimics a curved needle,
which allows for controlled depth of suture placement.
Figure 24.12 Closure of the gastrotomy with Eagle Claw VII. (Reprinted
from Philip W. Y. Chiu, Bing Hu James, Y. W. Lau, et al. Endoscopic
plication of massively bleeding peptic ulcer by using the Eagle Claw VII
device: a feasibility study in a porcine model. Gastrointest Endosc
2006;63:681–5 with permission from Elsevier.)
rately by another assistant. The use of the Eagle Claw has
been found to be technically demanding, and there is no
good method to avoid entrapment of extralumenal tissue
adjacent to the gastrotomy. The OverStitch (Apollo Endosurgery, Inc., Austin, TX, USA) is the most recent descendant
USGI g-Prox needle
The g -Prox from USGI Medical is a novel instrument that
combines an aggressive grasper with a needle delivery device
that delivers expandable baskets connected by permanent
suture [29] (Figure 24.13). The grasping function has large
jaws yielding deep, full -thickness tissue bites designed to
replicate the abilities of a laparoscopic grasper and has
similar dimensions. The instrument also permits the surgeon
to lift or pull tissue aggressively. The technique consists of
perforating the two margins of the defect with a 19 gauge
needle in which two expandable baskets connected by a
non-absorbable suture are loaded. Once both baskets are
released, pulling on one end of the suture causes approximation of the baskets, and consequently of the edges of the
enterotomy. The g -Prox tissue approximation device includes
Expandable Tissue Anchors that provide knot strength
without the diffi culty of endoscopic suture tying. The g -Prox
can be loaded and reloaded with g -Caths without withdrawing or repositioning the instrument.
Stapling systems
Power Medical Interventions ( PMI) SurgASSIST
Linear staplers for fl exible endoscopy are based on the same
technology that has been routinely used in open and laparoscopic surgery to obtain reliable closure of hollow organs
and safe anastomoses. In an ex vivo study, a fl exible linear
stapler by Power Medical Interventions (Langhorne, PA,
USA) was found to be able to obtain considerable burst
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Figure 24.14 ShapeLock before assembly of the device: disposable
sheath (blue) and reusable ShapeLock guide. (Reprinted from
Gottumukkala S. Raju, Pankaj J. Pasricha. ShapeLock: a rapid access port
for redeployment of a colonoscope into the proximal colon to facilitate
multiple polypectomies in a single session. Gastrointest Endosc
2005;61:768–70 with permission from Elsevier.)
pressures, comparable to running sutures [31]. The activation of linear staplers during endoscopy is relatively easy,
while in contrast the manipulation of the tissue within the
branches of the device seems extremely diffi cult, and therefore the technique is demanding.
Occluding systems
Nitinol cardiac occluder
The cardiac occluder system used to close septal defects has
been favored by the IRCAD group in Strasbourg for gastrotomy closure after testing multiple devices [32]. It consists of a self -expandable double -umbrella shaped device
that is made of a nitinol wire mesh. The two umbrellas are
linked together by a short connecting waist. When used for
gastric defect closure, the system raises a number of questions regarding the fact that one of the two disks remains
exposed on the peritoneal surface, not to mention the very
high costs of the device.
Multitasking platform
A key requirement of NOTES surgery, as identifi ed by the
NOSCAR, is a stable surgical platform to support and guide
fl exible endoscopes and instruments. Because some of the
NOTES procedures will require an interdisciplinary team to
guide, navigate, and manipulate the instruments, devices
with multiple ports are likely to be important [33]. Multiple channel endoscopes with separate moving arms or multibending endoscopes that can be stiffened are necessary.
Figure 24.15 ShapeLock after assembly of the device, with the
colonoscope passed through it and locked in position. (Reprinted from
Gottumukkala S. Raju, Pankaj J. Pasricha. ShapeLock: a rapid access port
for redeployment of a colonoscope into the proximal colon to facilitate
multiple polypectomies in a single session. Gastrointest Endosc
2005;61:768–70 with permission from Elsevier.)
ShapeLock TransPort
The ShapeLock TransPort (USGI Medical, Inc., San Clemente, CA, USA) is a multilumen operating platform designed
to address the challenges of endolumenal surgery [34]
(Figures 24.14 and 24.15). The TransPort has four working
channels: one to accommodate an endoscope for visualization and three others for large -diameter surgical instruments. The endoscope can be rotated within this channel to
regulate the visual horizon so that “up” is truly “up,” regardless of the position of the TransPort, thereby decreasing disorientation. The TransPort uses ShapeLock technology, which
allows it to be inserted via a natural orifi ce in a fl exible state.
It then can be locked into a rigid confi guration that conforms
to the patient ’s anatomy while preventing the intubated
hollow viscus from looping and allows for greater transmitted force to target tissues during biopsy and retraction. The
distal tip of the TransPort can be steered freely and locked,
allowing the user easier access to the target site and its visualization. The TransPort is capable of 180 ° retrofl exion as
well as lateral movements and can be frozen in place by
closing a lever, whereas the tip still has independent four way movement for fi ne surgical maneuvers. This creates a
multitasking platform through which advanced endolumenal and translumenal maneuvers may be performed that
require distant rigid retraction. According to Swanstrom and
Bardaro, triangulation is still minimal for the TransPort
device [35]. The complexity of the system requires skilled
and advanced assistants. The manual control of the system
does not allow smooth and precise movements of the end
of the scope and instruments.
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