Design and application of a new series of gallbladder endoscopes that facilitate

gallstone removal without gallbladder excision

Tie Qiao, Wan-Chao Huang, Xiao-Bing Luo, and Yang-De Zhang

Citation: Review of Scientific Instruments 83, 015115 (2012); doi: 10.1063/1.3673472
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REVIEW OF SCIENTIFIC INSTRUMENTS 83, 015115 (2012)
Design and application of a new series of gallbladder endoscopes
that facilitate gallstone removal without gallbladder excision
Tie Qiao,
1,a)
Wan-Chao Huang,
1
Xiao-Bing Luo,
1
and Yang-De Zhang
2
1
The Second Peoples Hospital of Panyu District, Panyu, Guangzhou 511470, Peoples Republic of China
2
The National Hepatobiliary and Enteric Surgery Research Center, Central South University, Changsha,
Hunan 410008, Peoples Republic of China
(Received 8 August 2011; accepted 5 December 2011; published online 31 January 2012; corrected
3 February 2012)
In recent years, some Chinese doctors have proposed a new concept, gallstone removal without gall-
bladder excision, along with transition of the medical model. As there is no specialized endoscope
for gallstone removal without gallbladder excision, we designed and produced a new series of gall-
bladder endoscopes and accessories that have already been given a Chinese invention patent (No.
ZL200810199041.2). The design of these gallbladder endoscopes was based on the anatomy and
physiology of the gallbladder, characteristics of gallbladder disease, ergonomics, and industrial de-
sign. This series of gallbladder endoscopes underwent clinical trials in two hospitals appointed by
the State Administration of Traditional Chinese Medicine. The clinical trials showed that surgeries of
gallstones, gallbladder polyps, and cystic duct calculus could be smoothly performed with these prod-
ucts. In summary, this series of gallbladder endoscopes is safe, reliable, and effective for gallstone re-
moval without gallbladder excision. This note comprehensively introduces the research and design of
this series of gallbladder endoscopes. 2012 American Institute of Physics. [doi:10.1063/1.3673472]
I. INTRODUCTION
Cholecystolithiasis is a common disease with a world-
wide incidence of 10%. The traditional treatment method
for more than 100 years has been cholecystectomy.
1, 2
In
recent years, gallstone removal without gallbladder excision
has been proposed as a novel treatment for such disease, but
implementation has been restricted by the lack of specialized
endoscopes.
What type of device could be used to carry out this novel
treatment? We researched and designed a series of hard chole-
cystoscopes and have clinically applied them since June 2007.
II. DESIGN
This series of hard cholecystoscopes includes the three-
channel hard cholecystoscope, single-channel hard cholecys-
toscope, mother-baby endoscope comprising a cholecysto-
scope and cystic duct endoscope, ultrasonic cholecystoscope,
and respective connection systems.
3
The former two scopes
were designed to treat gallbladder cavity lesions, the third was
designed to treat cystic duct lesions, and the last was designed
to treat lesions within the gallbladder wall.
Pro/ENGINEER was used as 3D modeling software in
the contour and physical design of these hard cholecysto-
scopes because of its present acknowledgement and important
position in the CAD(computer aided design)/CAE(computer
aided engineering)/CAM (computer aided manufacturing)
and 3D-modeling elds.
4
A gun type appearance was adopted in the contour de-
sign, which means that the eyepiece input terminal was sim-
ilar to a pistol grip, forming a 45

angle toward the principal

a)
Author to whom correspondence should be addressed. Electronic mail:
fqj1958@163.com. Tel.: 86-20-34999950. Fax: 86-20-34994386.
axis, while the photo-source input terminal was similar to a
trigger, situated perpendicular to the principal axis. This de-
sign may help doctors to operate very precisely, as if they are
gripping a handgun while performing surgery.
The optical system, another main part, was designed and
modeled by ZEMAX. Because the optical system is the most
delicate part in an endoscope, the requirement for the machin-
ing and assembling of the lens is very high. The miniature and
sophisticated lens were arranged in order and used in the op-
tical systems of the three- or single-channel hard cholecysto-
scopes. Meanwhile, delicate machines were chosen to grind
and polish the surface of the lenses to ensure their coaxiality
and optical capabilities. Lenses were arranged and assembled
precisely and debugged repeatedly to attain the presupposed
precision. Optical bers were used to transfer images because
they were more applicable to the optical system with lenses
of 2.0 mm or less despite the fact that they had insufcient
imaging quality.
57
The parameters of the optical system of
the endoscope as shown in Table I.
A. Design outline of the three-channel hard
cholecystoscope
The three-channel hard cholecystoscope was specically
designed to handle large lesions in the gallbladder cavity.
The inner diameter of its linear appliance channel is 3.0 mm,
such that every surgical instrument with an outer diameter of
2.8 mm or less (soft and hard biopsy forceps, stone-free bas-
kets, electric coagulation hemostats, hemostatic bars, ultra-
sonic mini-probes, laser probes, and microwave probes) is
allowed to pass through. This design has some advantages
in clinical application; for example, when gallstones are too
large to be directly extracted from the patients body, the op-
erator can use a ballistic gravel bar with air pressure to enter
0034-6748/2012/83(1)/015115/5/$30.00 2012 American Institute of Physics 83, 015115-1
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015115-2 Qiao et al. Rev. Sci. Instrum. 83, 015115 (2012)
TABLE I. Parameters of the optical system of the endoscope.
Hard endoscope type Lens (mm) View direction Field angle Magnication Depth of eld
Three channel endoscope 2.8 10

65

75

6 330 mm
Single channel endoscope 2.0 0

and 30

50

60

2 330 mm
Cystic duct endoscope 1.2 10

50

60

4 330 mm
the gallbladder cavity through the channel, break the stones
into pieces, and remove them in order.
8, 9
The front end of the cholecystoscope was designed as a
circular pipe (length, diameter, and thickness of 203.5, 6.5,
and 0.1 mm, respectively). The top of the pipe, termed the
apex department, contains the lens, light-guided optical bers,
and three exit channels (water entry channel, water exit chan-
nel, and appliance channel) (Fig. 1).
The three channels are the water entry channel
(1.0 mm), water exit channel (1.0 mm), and appliance
channel (3.0 mm). The valves of the water entry and exit
channels stretch toward the different sides of the main parts
and form an angle of 45

in relation to each other. In gen-

eral, the two uid entry and exit channels are used to maintain
clear vision in the operational area. On the other side, either of
them can be used as appliance channels as necessary so that
instruments with a diameter of 0.8 mm or less can be used
to enter the gallbladder cavity. Meanwhile, independent water
entry and exit channels allow water to freely enter and exit the
gallbladder cavity without affecting the operation. Moreover,
the gallbladder cavity can be expanded by water injection to
facilitate maintenance of a clear surgical eld.
B. Design outline of the single-channel hard
cholecystoscope
The single-channel hard cholecystoscope has generally
been applied to surgery of common gallbladder lesions. It has
FIG. 1. Apex of the three-channel hard cholecystoscope. (a) Optical lens,
(b) light-guide ber, (c) water entry, (d) appliance channel, and (e) water
exit.
a single appliance channel (2 mm) that is also used as wa-
ter entry and exit channel. The terminal of the single-channel
hard cholecystoscope (diameter 4.55 mm; length 267 mm) is
smaller than that of the three-channel cholecystoscope.
The top of the front end of this cholecystoscope, also
termed the apex, contains the lens, exit of the appliance chan-
nel, and light-guided optical ber. The design of the apex is
shown in Fig. 2.
Because of the body motion and gallbladder self-
contraction, stones within the gallbladder cavity can move
and disperse to the slender neck of the gallbladder or the cys-
tic duct, which forms a natural angle toward the bottom of
the gallbladder cavity. Considering the fact that the linear ter-
minal of the single-channel hard cholecystoscope cannot be
bent to enter these areas, a guiding cap made of silica gel can
be used to form a sheath over the apex. The guiding cap has
a bent angle from 10

to 30

, and the SHORE hardness is

55A. Meanwhile, its inner diameter is slightly smaller than
the outer diameter of the work terminal of the endoscope, so
the cap can be xed on the apex by self-elasticity and friction
force (Fig. 3).
C. Design outline of the cystic duct endoscope
The cystic duct endoscope was specially designed based
on the structure of the cystic duct. In general, the diameter
FIG. 2. Schematic diagram of the apex of the single-channel hard cholecys-
toscope. (a) Optical lens, (b) light-guide ber, and (c) exit of the appliance
channel.
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015115-3 Qiao et al. Rev. Sci. Instrum. 83, 015115 (2012)
FIG. 3. Guiding cap with a bent angle and the single-channel hard cholecys-
toscope. (a) Guiding cap with a bent angle and (b) the single-channel hard
cholecystoscope.
of the human cystic duct is 23 mm; thus, the diameter of
the cystic duct endoscope must comply with this. The diam-
eter of the front end is 2.8 mm, which not only ensures that
the endoscope enters the cystic duct, but that it also forms a
mother-baby endoscope with the three-channel hard chole-
cystoscope. Depending on the independent photograph cen-
ter and monitor, the mother-baby endoscope can simultane-
ously display images of both the gallbladder cavity and cystic
duct for the operator.
3
Using the three-channel hard cholecys-
toscope as a platform, the operator may precisely nd the en-
trance of the cystic duct and enter the duct through the appli-
ance channel with the cystic duct endoscope for observation
and operation.
9, 10
There are some differences between the single-channel
hard cholecystoscope and cystic duct endoscope, although the
design styles of both are basically similar:
1. The diameter of the front end of the cystic duct endo-
scope (2.8 mm) was less than that of the single-channel
hard cholecystoscope (4.55 mm).
2. The length of the front end of the cystic duct endo-
scope was 516 mm, while that of the single-channel
hard cholecystoscope was 370 mm. Such a design could
be adaptable to the whole length of the mother scope
and ensure enough operative space to avoid disturbance
when the mother scope was used simultaneously with
the cystic duct endoscope.
3. The optical systems of both also differed because of dif-
ferences in diameter and length of the front end.
D. Design outline of the ultrasonic cholecystoscope
In order to clearly observe the structure of the gallblad-
der wall, the ultrasonic cholecystoscope, which integrates the
subtle mini-ultrasonic probe and three-channel hard cholecys-
toscope, was designed. Using the appliance channel of the
three-channel hard cholecystoscope as a platform, the oper-
ator can use the work terminal of the mini-ultrasonic probe to
enter the gallbladder cavity and perform 3D stereo scanning
and linear scanning of each layer of the gallbladder wall in
a short distance. Thus, each layer of the gallbladder wall and
even the stones hidden in the wall are clearly shown through
the feedback images. In this way, doctors can eliminate all
stones in the patients body, including intramural stones.
1113
FIG. 4. System schematic diagram of the ultrasonic cholecystoscope.
(a) Three-channel hard cholecystoscope, (b) mini-ultrasonic probe, (c) host
of cold light source, (d) host of ultrasonic system, (e) host of camera system,
(f) function keyboard, and (g) monitor.
A schematic diagram of the ultrasonic cholecystoscope is
shown in Fig. 4.
The diameter and working frequency of the mini-
ultrasonic probe were designed to be 2.02.6 mm and 7.5
20 MHz, respectively. The sound beam penetration depth is
4050 mm when the frequency is 7.5 MHz, which is mainly
used for the diagnosis of pathological changes of the gall-
bladder wall and surrounding organs. On the other hand, the
20-mm sound beam penetration depth (12.520 MHz) is
mainly used for tiny local lesions of the gallbladder cavity and
wall. Based on the practical experience, the best photographic
quality is obtained when the distance between the probe and
tissue is 1020 mm.
E. Design and selection of the series of hard
cholecystoscope accessories
The series of hard cholecystoscope accessories consisted
of a gallbladder sludge-like stones absorbing box, host com-
puter system for the camera, and cold light source.
Sludge-like stones in the gallbladder cavity are as small
as sand with a diameter of 1 mmor less, and the mucous mem-
brane of the gallbladder is rough. For this reason, sludge-like
stones that form in the gallbladder can be compared with sand
sprinkled on the carpet, and they are difcult to completely
remove with common methods. The gallbladder sludge-like
stones absorbing box looks like a small horn that comprises a
large terminal part and a small tunnel connected to the front
end of the cholecystoscope (Fig. 5). The box can help doctors
FIG. 5. Gallbladder sludge-like stones absorbing box. (a) Large-diameter
terminal and (b) small-diameter terminal.
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015115-4 Qiao et al. Rev. Sci. Instrum. 83, 015115 (2012)
FIG. 6. Schematic diagram of the use of the sludge-like stones absorbing
box combined with the series of hard cholecystoscopes. (a) Negative-pressure
device, (b) gallbladder cavity, (c) sludge-like stones absorbing box, and (d)
three-channel hard cholecystoscope.
to conduct many operative techniques, such as those involv-
ing pushing, squeezing, and pressing. The box is a diaphanous
pipe made of silica gel, and its hardness is SHORE 40A60A
(the best is 55A). The water in/out channel is linked to the
interface of the vacuum aspiration equipment, which can be
used to absorb the sludge-like stones by negative pressure,
store stones in the horn-like tunnel, and nally remove them
thoroughly like a vacuum cleaner. A schematic diagram of the
use of sludge-like stones absorbing box combined with series
of hard cholecystoscopes is shown in Fig. 6.
All interfaces of these cholecystoscopes adopt interna-
tional standards so that they can connect to all standard cam-
era systems worldwide.
III. CONCLUSION
This series of hard cholecystoscopes that facili-
tate gallstone removal without gallbladder excision have
been authorized by a Chinese invention patent (No.
ZL200810199041.2) as specialized surgical instruments for
cholecystolithiasis. Several hard endoscopes in this series
have all been authorized by a Chinese invention patent,
including the three-channel hard cholecystoscope (No.
ZL200810026985.X), the single-channel hard cholecysto-
scope (No. ZL200820188854.7), the ultrasonic cholecysto-
scope (No. ZL2009200005583.1), and the mother-baby
endoscope comprising a cholecystoscope and cystic duct en-
doscope (No. ZL200910126984.7). In addition, the gallblad-
der sludge-like stones absorbing box has also been authorized
by a Chinese utility model patent (No. ZL200720049447.3).
These patent products underwent clinical trials in two
hospitals appointed by the State Administration of Traditional
Chinese Medicine after successful research and development.
With approval of the Medical Ethics Committee and informed
consent of patients, 120 patients with the appropriate surgi-
cal indications were continuously selected to undergo surgery,
observation, and recording of surgical information from April
16, 2009 to July 14, 2010. Surgical indications were as fol-
lows: (1) gallstones or gallbladder polyps with clinical symp-
toms, (2) gallbladder polyps with a diameter of 10 mm or
more, and (3) gallbladder stones complicated by gallbladder
polyps. All patients with gallbladder cancer or gallbladder at-
rophy and those who could not tolerate gallbladder surgery
were excluded. The ages of the 120 patients ranged from
18 to 70 years. The patients comprised 48 males and 72 fe-
males. A total of 98 patients had gallstones, 16 had gallblad-
der polyps, and 6 had gallbladder stones complicated by gall-
bladder polyps.
The clinical trials have shown that compared with the
OLYMPUS CHF-P20 choledochoscope, these hard cholecys-
toscopes are associated with no signicant difference in sur-
gical safety. The lighting quality in the working distance
(330 mm) showed no difference, but the image quality in
this range was clearer (Fig. 7). Furthermore, the hard chole-
cystoscopes also had an advantage in terms of the stabil-
ity of the endoscope canal, exibility, and reliability when
combined with complementary products. This new series of
FIG. 7. (Color) Images of every type of gallbladder lesion by the series of
hard cholecystoscopes. (a) Stones in the gallbladder cavity, (b) intermural
stones (stones shadow), (c) intermural stones (yellow ribbon), (d) tiny stones
in gallbladder mucosa, (e) stone in cystic duct (cystic duct (1), stone (2)),
and (f) gallbladder polyps, ultrasonic cholecystoscope (gallbladder cavity (1),
gallbladder wall (2), gallbladder polyps (3)).
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015115-5 Qiao et al. Rev. Sci. Instrum. 83, 015115 (2012)
endoscopes could be used to completely remove gallbladder
cavity stones, intramural stones, tiny gallbladder stones, and
cystic duct stones. Bile leakage, bleeding, and other adverse
events did not occur intraoperatively or postoperatively in any
patient. The average hospital stay was ve days.
All 120 patients were followed up after surgery. As of
December 31, 2010, 109 patients were continuing follow-up,
including ve patients with recurrence of gallbladder stones.
Recurrence of stones and polyps was determined based on the
results of the most recent B-type ultrasonic scanning exami-
nation. Recurrence of gallbladder stones or polyps and other
complications were not found in the remaining 104 patients.
The short follow-up time was a limitation of this study.
In summary, the development of this series of cholecys-
toscopes offers instrumental support and the prospect of im-
proved surgical outcomes for gallbladder stones and polyps
without gallbladder excision.
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