Int J Artif Organs 2014; 37 ( 5 ): 392-401 DOI: 10.5301/ijao.

5000308

ORIGINAL ARTICLE

Assessment and in vitro experiment of artificial anal

sphincter system based on rebuilding the rectal
sensation function
Peng Zan, Jinding Liu, Enyu Jiang, Hua Wang

School of Mechatronics Engineering and Automation of Shanghai University, Shanghai Key Laboratory of Power Station
Automation Technology, Shanghai - PR China

In this paper, a novel artificial anal sphincter (AAS) system based on rebuilding the rectal sensation
function is proposed to treat human fecal incontinence. The executive mechanism of the traditional
AAS system was redesigned and integrated for a simpler structure and better durability. The novel
executive mechanism uses a sandwich structure to simulate the basic function of the natural human
anal sphincter. To rebuild the lost rectal sensation function caused by fecal incontinence, we propose
a novel method for rebuilding the rectal sensation function based on an Optimal Wavelet Packet Basis
(OWPB) using the Davies-Bouldin (DB) index and a support vector machine (SVM). OWPB using a DB
index is used for feature vector extraction, while a SVM is adopted for pattern recognition.
Furthermore, an in vitro experiment with the AAS system based on rectal sensation function rebuild-
ing was carried out. Experimental results indicate that the novel executive mechanism can simulate
the basic function of the natural human anal sphincter, and the proposed method is quite effective for
rebuilding rectal sensation in patients.

Keywords: Artificial anal sphincter system, Executive mechanism, Rectal sensation function rebuilding,
Optimal Wavelet Packet Basis, Support vector machine
Accepted: January 10, 2014

INTRODUCTION the anal canal, a pressure-regulating balloon, and a sepa-

Fecal incontinence is the result of numerous disorders af-
fecting the anatomy and physiology of the anorectum. It
mainly manifests as recurrent, uncontrolled passage of
solid or liquid dejecta or gas. Fecal incontinence not only
brings physical and mental sufferings to patients, but also
seriously affects patients’ orthobiosis and work (1). Tra-
ditional therapeutic methods such as biofeedback (2, 3),
sacral nerve stimulation (4, 5), colostomy, and ileostomy
(6, 7) can treat fecal incontinence to some degree, how-
ever, with limited success.
An artificial anal sphincter (AAS) has been employed to
alleviate fecal incontinence. The traditional structure of an
AAS is composed of a circular compression cuff enclosing
rate pump by which the patient can inflate and deflate the
cuff (8, 9). However, there are mainly two limitations for the
existing AAS. One is that patients have to pinch the pump
with their hand in order to defecate. The other defect is that
patients are unaware of when to defecate because of the
loss of rectal sensation function, which has become the
most sophisticated problem restricting the development
of an AAS. Thus, there is an urgent need to rebuild rectal
sensation function in order to promote the further develop-
ment of an AAS system.
To solve these problems, a new AAS prosthesis based on
rectal sensation function rebuilding is presented in this pa-
per. The aim is to redesign and integrate a novel executive
mechanism with a simpler structure and better durability to

392 © 2014 Wichtig Publishing - ISSN 0391-3988

Zan et al
simulate the normal physiology of the human anorectum.
The detailed structure model of the executive mechanism
is discussed, and then its performance characteristics are
assessed with a measurement experiment we established
to ensure reliability.
Furthermore, a method for rectal sensation function re-
building based on optimal wavelet packet (OWP) and sup-
port vector machine (SVM) is proposed to predict the urge
to defecate. Finally, an in vitro experiment of the novel AAS
system based on rectal sensation function rebuilding is
carried out. Experimental result indicates that the proposed
method is quite effective to predict the urge to defecate.
SYSTEM OVERVIEW
The novel AAS system proposed in this paper is based
on rectal sensation function rebuilding to treat fecal in-
continence. The system consists of two components: the
one, implanted in the body of patients, is called the im-
planted component, while the other, set outside the body,
are the outside components. The two components are
© 2014 Wichtig Publishing - ISSN 0391-3988
Fig. 1 - Outline of AAS system.
highly integrated and the fact that there is no wire linking
the implanted and outside components ensures that the
implantation is less risky and has fewer complications.
Also, the system comprises three key modules, including
the sensor and executive module, the transcutaneous en-
ergy transmission module, and the wireless communica-
tion module as shown in Figure 1.
The sensor and executive module comprises a sensor unit
and a novel executive mechanism. The sensor unit placed
closely to the anal canal acts in the role of the natural nerve
system, which has always monitored the pressure signal of
the anal canal and transmitted the signal to the inside con-
troller. The novel executive mechanism which simulates
the basic function of human nature anal sphincter is used
to prevent unwanted leakage of feces.
Driving energy for the implanted component is provided
by transcutaneous energy transmission module based on
electromagnetic coupling. Two copper coils separated by
the skin are facing each other closely to transmit energy
in the maximal degree. Then some regularization must be
processed on the initial energy to satisfy the power stan-
dard for the whole implanted component.
393
Assessment and in vitro experiment of artificial anal sphincter

Fig. 2 - Prototype of the AAS system.

The communication between the implanted and outside

components is realized through wireless communication
module. It ensures that the implanted component does not
have any wire link with the outside component. Date and
command is transmitted through the module to ensure that
the system operates normally. This method is the only way Fig. 3 - Mechanism of defecation control.
to eliminate possible infection caused by wire linking and
surgery to replace the battery, which has a great signifi-
cance for the implanted AAS system.
Figure 2 shows the prototype of the AAS system which in-
tegrates the above three modules together. An alarm and
display unit is designed to inform patients that the urge
to defecate has been detected. As is shown in Figure 2,
the alarm and display unit is integrated with the outside
wireless communication module in a PCB board. Based
on the division of the two copper coils, the left side is
regarded as the outside component and the right side is
the implanted component. A 12 V experimental recharge-
able battery is used to power the entire outside compo-
nent while the driving energy for the inside component
is provided by the transcutaneous energy transmission
module.
To simulate a natural defecation process, all the constitu- Fig. 4 - The novel executive mechanism.
ent parts of the AAS system must coordinate closely with
each other. The mechanism of defecation control can be The novel executive mechanism
described by Figure 3. When the urge to defecate is de-
tected, the patient starts the defecation process by just Inspired by the sandwich structure AAS (10-12), we designed
pressing the “start” button. And when the defecation is a hinge structure executive mechanism which is actuated
finished, patients only need to press the “stop” button to by a DC push-draw electromagnet as shown in Figure 4.
shut off the executive mechanism. The whole defecation The hinge structure is formed by two thin sheets covered
process is no different from that of people unaffected by by a silicon rubber diaphragm. Composition of the two thin
fecal incontinence. sheets used in this study is medical titanium nickel alloy. The

394 © 2014 Wichtig Publishing - ISSN 0391-3988

Zan et al

circumferential shape block at the end of the hinge structure

is used to replace the anal sphincter muscles and to control
the opening and closing of the anal canal. To prevent the
probable fistula, the circumferential shape block has a small
radian to disperse the compression force around the anal
canal. It is made of silicone rubber with softness and high
tenacity to reduce compression injury of the anal canal. As
the actuator, a DC push-draw electromagnet is associated
with the upper thin sheet through a slide block.
The novel executive mechanism has a simple structure and
its operation is more convenient than the traditional de-
sign. When the DC push-draw electromagnet is not electri- Fig. 5 - Predication model for rectal sensation function rebuilding.
fied, its spring is in a state of compression. The two alloy
boards of the hinge structure will be put together under the
action of the spring force to clamp the anal canal. When
the patient needs to defecate, simply by electrifying the
electromagnet, the anal canal can be opened to pass fe-
ces. To prevent the mechanism from corroding, a sealing
material made of a silicone rubber diaphragm should cover
the whole mechanism.
Fig. 6 - The tree structure of wavelet packet decomposition.
Establishment of prediction model for
rectal sensation width distribution information because it decomposes
both the low-frequency and high-frequency parts of rectal
Rectal sensation predication model signal. In view of the typical nonlinearity and nonstation-
ary characteristics of the rectal signal, the combination of
Related medical research indicates that high-amplitude the time and frequency domains can yield more informa-
propagated contractions (HAPC) signals in the biomedical tion. Hence, the wavelet packet coefficients mean (time
signal can be used to indicate the urge to defecate (13). domain information) and the relative energy (frequency
However, the collected HAPC signal always contains other domain frequency) in every subspace are employed as the
contractive waves, so the time-frequency domain feature signal features.
is more conducive for pattern recognition of the rectal sig- Assume that the original rectal signal x(n) is a finite energy
nal. Wavelet packet decomposition is an effective time- signal and J series wavelet packet decomposition. W 00 is
frequency domain analytical tool. In this paper, an optimal operated on the signal. Figure 6 shows the tree structure
wavelet packet basis based on the DB index is adopted for of wavelet packet decomposition. is the original signal
feature vector extraction. Feature vectors are then input- space and Wj p ( p = 0,1,..., 2 j −1) denotes the pth subspace
ted to the SVM to predict the urge to defecate. The HAPC occurring at the jth decomposition level. The wavelet
p
signal detected in the rectal signal means occurrence of packet coefficients of the subspace W j are described by
the urge to defecate. The predication model is described d jp = {d jp ( k ), k = 1, 2,..., K jp } . The computation method of
in Figure 5. wavelet packet coefficients mean and the relative energy
in every subspace is presented as described below.
Feature extraction based on wavelet packet 1.  The wavelet packet decomposition coefficient mean
decomposition MEAj, p in every subspace is adopted as the original
coefficients mean feature set M.
Many applications of wavelet packet decomposition
1
have been reported in biomedical signal analysis (14-16). MEAj , p = ∑ d jp ( k ), [1]
nj , p k
Wavelet packet decomposition can obtain detailed band-

© 2014 Wichtig Publishing - ISSN 0391-3988 395

Assessment and in vitro experiment of artificial anal sphincter

p
where nj, p is the coefficient length of subspace W j . So the tion ability of feature space (17-19). Hence, the DB index is
original wavelet packet coefficients mean feature vector adopted in this paper to measure the classification ability
set is and to select the optimal wavelet packet basis.
The DB index is based on the scatter matrices of the data.
M = {MEAj, 0, MEAj, 1,...,MEAj, p}, P = 2j – 1.[2] The DB index is obtained through determining the worst
case of separation for each cluster and averaging these
2. The relative energy Pj, p in every subspace is adopted as values as follows (20):
the original relative energy feature set N.
1 K
DB = ∑ max Rij ,
K i =1 i ≠ j
[7]
The energy of the pth subspace occurring at the jth de-
composition level is where K is the number of clusters to distinguish and clus-
ter-to-cluster similarity is:
2
E j , p = ∑ (d jp ( k )) . [3]
k ( Dii + D jj )
Rij = , [8]
Dij
The total energy of the jth decomposition level is
where Dii and Dj j denotes the dispersions of cluster i and
TE j = ∑ E j , p . [4] cluster j respectively, Dij is the distance between the mean
p
value of cluster i and cluster j. The value can be obtained
The relative energy Pj, p in every subspace is through the following formula:
1/ 2
1 Ni 
∑
2
Pj , p = E j , p / TE j . [5] Dii =  y n − mi  [9]
 Ni n=1 
The original relative energy feature set is and  Dij = mi − mj , [10]

N = {Pj , 0 , Pj , 1,..., Pj , p }, P = 2 j − 1. [6] where Ni is the number of members in cluster i, yn is the

Hence, we obtain the original feature vector set is X = {M, N}.
Optimal wavelet packet basis based on the
Davies-Bouldin (DB) index
It is worth noticing that wavelet packet decomposition pro-
vides numerous effective signal decomposition forms. As
shown in Figure 6, an effective signal decomposed form
consists of W10  W11, W20  W21  W11, W20  W21  W22  W23 ,
etc. Assume that G = {G1, i = 1, 2, 3, ...} is the set of all
the effective decomposed forms. So G is the wavelet
packet bases library and Gi is one of the wavelet packet
bases.
Each wavelet packet basis has its unique property that re-
flects a certain feature of signal. Inadequate or excessive
numbers of wavelet packet bases increase the miscella-
neous degree of the algorithm. The aim of the optimal wave-
let packet decomposition is to select an optimal wavelet
packet basis for classification problems from the library of
wavelet packet bases. The Davies-Bouldin (DB) index has
been proved effective when used to evaluate the classifica-
nth sample vector of cluster i, and mi is the mean vector of
cluster i. It is obviously that a smaller DB index value indi-
cates a better feature classification ability (20).
In the following, the optimal wavelet packet basis search
algorithm based on DB index is given. Suppose set B =
(Bjp j = 0,1,...; p = 0,1,...,2i –1) and set A = Φ, where Bjp
is the set of basis vectors belonging to the subspace Wj p.
Step 1: Find the basis vector Bkl in set B, where Bkl is cor-
responding to the subspace which has the least
DB index value. Then add Bkl to set A and remove
Bkl from B.
Step 2: ∀B xy ∈ B, if B xy is corresponding to the child node
space (direct or indirect) or parent node space of
Bkl , then remove Bxy from set B.
Step 3: If B = Φ, stop the algorithm, else return to Step
2 and continue.
The subspace corresponding to the selected wavelet
packet basis must cover the horizontal range completely.
Overlap of any subspace in the horizontal direction should
be avoided. The final set A is exactly the optimal wavelet
packet basis based on the DB index.

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Zan et al

Support machine vector (SVM)

Assume that the linearly separable sample set is (xi, yi),

i = 1,2,..., n, x ∈ Rd, y ∈ {+1, –1} is class label. The hyper-
plane in D dimension is described by w · x + b = 0, where
w is the weigh vector and b is the offset. For nonlinear
problems, it is necessary to map input space to a high-
dimensional space by nonlinear transformation x → φ (x).
Then nonlinear classification in low-dimensional space can
be replaced by the linear classification problem in the high-
dimensional space.
Seeking the best hyperplane can be described as minimi-
zation of formula [11]:

1  n 
F= (w·w ) + C ∑ ξi  , [11]
2  i =1  Fig. 7 - Characteristic curve of the electromagnetic and spring forces.

s.t. yi [w . φ (xi) + b] –1 + ξi ≥ 0, i = 1, 2,..., n,

where c is penalty factor and xi is slack variable. A Lagrange

Experiment analysis
function is introduced to solve the convex secondary opti-
Clamping force measurement experiment
mization problem of formula [11]:
Selecting a suitable clamping force for the executive mech-
n
1
w + c∑ ξ i
2
L(w, b, ξ , α,η ) = anism is a serious problem urgently needed to be solved.
2 i =1 From a theoretical point of view, a large enough force can
n n
−∑ α i ( y i (w T φ ( x i ) + b) − 1 + ξi ) − ∑ ηi ξi , [12] guarantee unnecessary feces loss. However, long-term
i =1 i =1
oversize force imposed on the rectum easily causes com-
where ai and ηi are Lagrange multipliers. With the partial pression injury. Related medical research indicates that the
differential of master variable in formula [14] and formula suitable clamping force is 80 mmHg to 120 mmHg. With
[13] and formula [14], we got the formula: the aim of reducing harm to human issues as far as pos-
N N N
sible, a slightly smaller force 10 kPa (about 75 mmHg) is
1
W(α ) = ∑ α − 2∑∑α α y y φ
i =1
i
i =1 j =1
i j i j
T
( x i ) φ ( x j ). [13] used for the clamping force in this paper. Then its sealing
effect is evaluated in the following way.
Kernel function K(xi , xj) = φT (xi) φ (xj) is used to simplify for- To evaluate the performance characteristics of the execu-
mula [13]. Any functions that satisfy Mercer’s condition tive mechanism, we established a measurement system
could be used as kernel function, while different kernel which comprises the executive mechanism, a dynamom-
function would have different classification prediction ac- eter, and an adjustable DC power supply. Figure 7 shows
curacy. Radial basis function (RBF) kernel function is used the characteristic curve of electromagnet Force-Displace-
in this paper. ment (F − x) and spring Force-Deformation (F − ∆x). The
 x −x 2  black line indicates the relationship of spring F − ∆x. The
 ,
K ( x i , x j ) = exp −
i j
 [14] remaining three curves indicate the characteristic curve
 2σ 2
of electromagnetic F − x respectively under the different
where K is the kernel function and σ is kernel function working voltage.
width. Hence, the optimization decision function takes the The spring force is proportional to its deformation within
form: the spring elastic deformation range, which manifests as
n
a linear straight line in Figure 7. As for the F − x character-
f (x) = sgn ( ∑ α i y i K ( x, x i ) + b). [15] istic, a higher working voltage generates a larger electro-
i =1
magnetic force. When the working voltage is maintained,

© 2014 Wichtig Publishing - ISSN 0391-3988 397

Assessment and in vitro experiment of artificial anal sphincter
a b
Fig. 8 - Coefficients mean of each subspace. a) Three kinds of Class 1 signal. b) Three kinds of Class 2 signal.
the electromagnetic force increases as the moveable core
approaches the stationary core and the two limit values
obviously differ. When the working displacement x is be-
tween 4~10 mm, the characteristic curve F − x is approxi-
mately horizontal, which means a constant force.
The clamping force imposed on the rectum is created by
the spring compressive deformation, so an increase in in-
testinal contents results in extra compressive deformation,
which in turn generates an extra force to keep the closing
state. When the electromagnet is working at 12 V voltage
with maximum current 0.15 A, the electromagnet tempera-
ture rises about 30°C within a continuous 30-minute pe-
riod, which causes no harm to human tissues. Repeated
tests indicate that the sealing effect is good enough to
maintain the pressure and prevent feces leakage.
Experiment for rebuilding rectal sensation
The biological parameters telemetry capsule made by
Shanghai Jiaotong University was used for rectal pressure
signal acquisition of 10 healthy volunteers, including six men
and four women. One hundred groups of data with 10 times
per person were acquired. Four wrong groups were aban-
doned, while the remaining 96 groups of data were filtered
and de-noised. Then 62 groups of data were selected as
training samples and 34 groups of data as test samples. The
samples with HAPC signal were regarded as Class 1, which
398 © 2014 Wichtig Publishing - ISSN 0391-3988
indicates the urge to defect. The samples without HAPC
signal were regarded as Class 2, which means no need to
prepare for defecation.
The Db3 wavelet with the best regularity properties was
chosen as the mother wavelet to decompose the rectal
pressure signal. Three-layer wavelet packet decomposi-
tion was operated on the rectal pressure signal and 15 dif-
p
ferent subspaces Wj were obtained. Then the coefficient
mean MEAj, p and relative energy Pj, p in each subspace
was obtainable according to Formula [1] and Formula [5]
respectively, as shown in Figures 8 and 9.
We adopted three kinds of class 1 signal and three kinds
of class 2 signal to extract feature vector to predict the
urge to defecate. The feature vector of the Class 1 signal
is shown in Figure 8a and Figure 9a; the feature vector of
the Class 2 signal is shown in Figures 8b and 9b. As the
DB index algorithm is based on the entire wavelet pack-
et decomposition tree, 14 MEAj, p and 14 Pj, p should be
calculated. So M is a 14 dimension feature vector of the
subspace coefficient mean and N is a 14 dimension fea-
ture vector of the subspace relative energy. As is shown
in Figures 8 and 9, the subspace number 1, 2, 3,..., 14
denotes the subspace W10 ,W11,W20 ,...,W37 respectively. So
the original feature vector set X = {M, N} can be obtained,
where X is a 28 dimension vector.
The DB index of each subspace in each layer is calculated
according to Eq. [7], and then selection of optimal wavelet
Zan et al

a b

Fig. 9 - Relative energy of each subspace. a) Three kinds of Class 1 signal. b) Three kinds of Class 2 signal.

Fig. 10 - The DB index in each sub-

space.

packet basis is extracted with the optimal wavelet packet TABLE I - PREDICTION ACCURACY OF SUPPORT VIRTUAL
basis search algorithm based on the DB index (see above MACHINE
“Optimal Wavelet Packet Basis based on Davies-Bouldin
Predication Kernel Test sample Correct Predication
index”). One optimal wavelet packet basis selection pro-
model function number predication accuracy
cess is shown in Figure 10. The value in each subspace is
the DB index value of the subspace. The colored subspace SVM RBF 34 33 97.06%

is the optimal wavelet packet basis based on DB index, that
is W20 , W32 , W33 , W34 , W35 and W23 . Based on the subspaces
corresponding to the selected optimal wavelet packet ba-
sis, the MEAj, p and Pj, p which are not belong to the sub-
spaces from feature vector M and N are removed. The goal
to simplify the original feature vector set X = {M, N} is thus
achieved.
In the end, the simplified feature vector X′ = {M′, N′} of
62 groups of training data is inputted into the SVM for
model training. Then the 34 groups of test data are input-
ted to the SVM to testify the effectiveness of the proposed
algorithm. The RBF kernel is used in this paper for the
SVM = support virtual machine; RBF = radial basis function.
SVM. When the HAPC signal is detected in any group of
test data, it indicates occurrence of the urge to defecate.
The prediction accuracy of the SVM with 34 groups of test
sample is shown in Table I. The test prediction accuracy is
97.06% and the operating time is 2.13 s.
According to the subspaces corresponding to the opti-
mal wavelet packet basis based on THE DB index, the
coefficients mean and relative energy in each subspace
was selected as a feature vector to predict the urge to

© 2014 Wichtig Publishing - ISSN 0391-3988 399

Assessment and in vitro experiment of artificial anal sphincter
Fig. 11 - The prototype of the artificial anal sphincter system.
defecate. The predication accuracy can reach up to
97.06%. The experiment results show that the selected
feature vectors can indicate the major feature to predict
the urge to defecate.
In vitro experimental system
All the modules were integrated to assemble the pro-
totype of the AAS system. The prototype and a human
model were combined to form the platform of an in vitro
experimental system. Considering that the diameter size
of the human anal canal is similar to the small intestine
of the pig, the fresh small intestine of a pig is applied
to simulate the anal canal which is directly in contact
with the executive mechanism. A plastic pipe is applied
to simulate the remaining part of the human rectum. The
fresh small intestine is connected to the terminal of
the plastic pipe and the executive mechanism clamps
the terminal of the fresh small intestine. As is shown in
Figure 11, the outside component is placed in front of the
human model. With a display and alarm unit, the patient
can notice the alarm signal when the urge to defecate is
detected.
400 © 2014 Wichtig Publishing - ISSN 0391-3988
a b
Fig. 12 - The experiment on rectal sensation function rebuilding
when injecting the semifluid into the in vitro system indicates that the
novel executive mechanism can simulate the basic function of the
natural anal sphincter, and the proposed algorithm is quite effective
for rebuilding the patient’s rectal sensation. a) Closed state to clamp
the intestine. b) Open state for passing feces.
Firstly, the transcutaneous energy transmission module is
activated to power the entire system and make sure the
wireless communication module is operating normally. In
the original state, the executive mechanism is in a closed
state to clamp the terminal of the small intestine, as shown
in Figure 12a. Then semifluid from the over shedding of
the plastic pipe is injected until the fresh small intestine
is full with semifluid. At the same time, the executive and
sensor module monitors the pressure signal of the small in-
testine. When the urge to defecate is detected, the execu-
tive mechanism opens its hinge structure to pass feces, as
shown in Figure 12b.
CONCLUSIONS
To treat human fecal incontinence, a novel artificial anal
sphincter (AAS) system based on rebuilding rectal sensa-
tion function is proposed in this paper. A novel execu-
tive mechanism with a sandwich structure is designed
to simulate the basic function of the natural human anal
sphincter. To solve the rectal sensation loss problem
caused by fecal incontinence, a method for rebuilding
the rectal sensation function is proposed. By extracting
the rectal pressure feature with the OWPB based on the
DB index, the coefficients mean and relative energy in
each subspace after wavelet packet decomposition are
taken as feature vectors, and the trained SVM is used
to predict the urge to defecate. Experimental results in-
dicate that the novel executive mechanism can simu-
late the basic function of the nature anal sphincter, and
the proposed method is quite effective in rebuilding the
patient’s rectal sensation.
Zan et al
Financial Support: This work was supported by National Natural
Science Foundation of China (No. 31100708, No. 31370998) and
Natural Science Foundation of Shanghai (No.11ZR1412400).
Conflict of Interest: None.
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© 2014 Wichtig Publishing - ISSN 0391-3988
Address for correspondence:
Hua Wang
School of Mechatronics Engineering and
Automation of Shanghai University
Shanghai Key Laboratory of Power Station Automation Technology
Shanghai 200072, PR China
wanghua6091@163.com
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