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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

View online: http://dx.doi.org/10.1063/1.3673472

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REVIEW OF SCIENTIFIC INSTRUMENTS 83, 015115 (2012)

Design and application of a new series of gallbladder endoscopesthat facilitate gallstone removal without gallbladder excision

Tie Qiao,1, a) Wan-Chao Huang,1 Xiao-Bing Luo,1 and Yang-De Zhang21The Second Peoples Hospital of Panyu District, Panyu, Guangzhou 511470, Peoples Republic of China2The 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 fields.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:[email protected]. 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 grindand 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 fibers 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 insufficient

imaging quality.57 The parameters of the optical system of

the endoscope as shown in TableI.

A. Design outline of the three-channel hardcholecystoscope

The three-channel hard cholecystoscope was specificallydesigned 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 Physics83, 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 Magnification Depth of field

Three channel endoscope 2.8 10 6575 6 330 mm

Single channel endoscope 2.0 0 and 30 5060 2 330 mm

Cystic duct endoscope 1.2 10 5060 4 330 mm

the gallbladder cavity through the channel, break the stonesinto 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 fibers,

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 fluid entry and exit channels are used to maintainclear 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 field.

B. Design outline of the single-channel hardcholecystoscope

The single-channel hard cholecystoscope has generallybeen applied to surgery of common gallbladder lesions. It has

FIG. 1. Apex of the three-channel hard cholecystoscope. (a) Optical lens,

(b) light-guide fiber, (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 fiber. 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 bebent 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 fixed 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 fiber, and (c) exit of the appliance

channel.


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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 find 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 hardcholecystoscope 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 sandwith a diameterof 1 mmor less, and the mucousmem-

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 difficult 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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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 finally 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 significant 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, flexibility, 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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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 five days.

All 120 patients were followed up after surgery. As of

December 31, 2010, 109 patients were continuing follow-up,

including five patients with recurrence of gallbladder stones.

Recurrence of stones and polyps was determined based on theresults 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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