A Novel Porous Structural Design of The Orthotic Insole For Diabetic Foot Chen2021

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 5

2021 International Conference on Computer, Control and Robotics

A Novel Porous Structural Design of the Orthotic Insole for Diabetic Foot

Tong Chen, Mengqian Tian*, Xingsong Wang


2021 International Conference on Computer, Control and Robotics (ICCCR) | 978-1-7281-9035-8/20/$31.00 ©2021 IEEE | DOI: 10.1109/ICCCR49711.2021.9349389

College of Mechanical Engineering


Southeast University
Nanjing, Jiangsu Province, China
e-mail: tianmq@seu.edu.cn

Abstract—Diabetic foot is a common complication of diabetes symptoms [6]. Lei Tang proposed a functional gradient
with a significant symptom of excessive plantar pressure. porous structural design of insoles, helping in increasing the
Studies have shown that reducing plantar pressure can foot contact area and reducing the peak contact pressure [7].
effectively lower the incidence of diabetic foot. In this work, a Ayfer proposed a type of fabrication of the diabetic insoles
new design method is proposed to reduce plantar pressure by by fused-deposition modeling method, and the cost was cut
dividing the orthotic insole into two areas. Support area is off compared to traditional foam casting [8].
under the midfoot and shares a part of plantar pressure Another rising area is the collection of plantar parameters
compared to flat structure. Soft area helps in decreasing the for smart healthcare. Telfer demonstrated the feasibility of
plantar pressure of the forefoot region and rearfoot region by
using embedded sensing foot orthosis to monitor foot
low young’s modulus structure. Honeycomb structure and
auxetic structure are applied in the novel porous insole. The
temperature during normal activities [9]. Julian reviewed the
orthotic insoles were manufactured by fused-deposition development of the plantar pressure measurement system,
modeling. Finite element analyses show that the auxetic which can be employed to detect many kinds of chronic
structure of soft area enhances larger deformation than diseases and offer treatment suggestion [10].
ordinary flat structure by 18% under pressure. Results show Therefore, there is a vital need for orthotic insoles that
that the support area reduces the pressure of the forefoot prevent foot from nimiety stress in daily life. Based on 3D
region and rearfoot region by 30% during upright position. scanning technology and 3D printing technology, we have
The scene of wearing orthotic insoles with pressure sensors is designed a kind of novel insole to meet the plantar pressure
explored. Consequently, the novel porous insoles can be used to reduction. The porous insole is composed of auxetic
bring better plantar pressure reduction for the treatment of structure and honeycomb structure. The finite element
diabetic foot. analysis and experiment shows that the novel insoles could
effectively reduce the plantar pressure compared to ordinary
Keywords-diabetic insole; wearable device; smart healthcare; flat structure insole.
porous structural units; additive manufacturing
II. METHOD
I. INTRODUCTION
A. Design Object and Materials
Diabetes mellitus is one of the common chronic disease
with some complications. In recent years, there has been a In this paper, the insole is divided into two areas with
significant increase in the number of diabetic foot problems. different structures to meet the requirements in Fig. 1(a). The
Diabetic foot reflects excessive plantar pressure, which can soft area includes the forefoot region and rearfoot region, and
lead to lower extremity amputation in severe cases [1]. Most the support area includes the midfoot region. During a gait
of the diabetic foot conditions could be prevented and cared cycle, the peak plantar pressure always appears in the
by medical wearables device like orthotic insoles [2]. Many forefoot region and rearfoot region. The soft area adopts
scientists have turned their attention to the customized auxetic structure with the purpose of reducing plantar
orthotic insoles, which offer best fitting and plantar pressure pressure in Fig. 1(b). Auxetic structure is a typical porous
reduction. structure, which exhibits lateral expansion under axial
Finite element simulation provides a vast amount of data, tension while lateral contraction under compression [11]. It
which can be useful in the design of orthotic insole [3]. can be used for energy absorption. The support area not only
Reasonable insole structure and soft material will be of great prevents the arch of the foot from being compressed but also
significance to reduce the plantar pressure and improve the shares a certain amount of plantar pressure. The support area
rehabilitation effect effectively [4]. Goske focused his is composed of honeycomb structure and solid arch support
research on the mechanical property of flat insole and full- in Fig. 1(b). The honeycomb structure is under the solid arch
conforming insole. The comparison indicated that the full- support and has high rigidity. The fit surface is obtained by
conforming insole provided the better plantar pressure boolean operation with the foot model, the solid model
reduction in heel region [5]. Hajizadeh suggested that the increases the contact surface with the arch of the foot to
arch support could be applied to insole design to avoid optimize the pressure distribution, and the orthotic insoles
excessive pronation, anterior knee pain and arthritis are manufactured in Fig. 1(c).

978-1-7281-9035-8/21/$31.00 ©2021 IEEE 188

Authorized licensed use limited to: University of Canberra. Downloaded on May 22,2021 at 18:58:08 UTC from IEEE Xplore. Restrictions apply.
B. Support Area
Honeycomb structure is a kind of porous structure with
high stiffness and can be used for carry load. The
honeycomb units’ side length of regular hexagons is 1.75mm,
and the wall thickness between two units is 1mm. This size
of the honeycomb unit owns 56.5% porosity compared to
solid structure. A three-dimensional scanner was used to
collect a foot model in Fig. 3(a). The volunteer put his foot
on the platform, and the experimenter held the scanner to
collect the point cloud data at a speed of 30 seconds per
revolution, then the data were post-processed by Skanect 3D
and exported into a STL file in Fig. 3(b). In Rhino 5.0, we
performed boolean operation on the arch model to obtain
arch support that fits the arch, then the honeycomb structure
and arch support are combined with each other in Fig. 3(c).

Figure 1. (a) areas of insole (b) structures of insole (c) 3D printed insole.

As an emerging 3D flexible printing material,


thermoplastic polyurethanes (TPU) can meet the comfort and
safety of insoles. We build a three-dimensional model
according to the standard GB / T 528-2009 and then
exported it into a STL file. The printing conditions such as
printing temperature, layer height and fill density have an
influence on the mechanical properties of the specimens.
Based on the experimental equipment and selected materials,
the printing parameters are shown in Table I. Then we used a
universal tensile testing machine to perform uniaxial tensile
experiments on the three specimens. The loading speed was
50mm / min during the experiment in Fig. 2(a). The three
tensile test data were averaged, and the stress-strain curve
was obtained in Fig. 2(b). In Abaqus 6.14, we used the
function of fitting the uniaxial tensile data in the material
module and selected the Yeoh model with the greatest fitting
performance to the experimental data.
TABLE I. PRINTING PARAMETERS
Figure 3. (a) 3D scanner (b) foot model and arch support (c) support area.
Print parameters Value
Layer height (mm) 0.2
Fill density (%) 20 C. Soft Area
Print speed (mm/s) 40 Auxetic structure was used to form the soft area.
Printing temperature (℃) 210
According to the limitation of 3D printing forming accuracy
Nozzle size (mm) 0.4
for auxetic structure, the thickness of the insole was set to
6mm. The soft area was divided into cubes with a side length
of 6mm. The design idea of this auxetic structure originates
from the rotating square structure in Fig. 4(a). Firstly, the
values of the long axis and short axis of the ellipse were set
to form a mutually perpendicular array in Fig. 4(b). Then the
pattern was cut in the x direction and y direction. When the
unit is under stress in the z direction, the four corners rotate
and shrink inward, and it will show negative Poisson's ratio
macroscopically. Three different auxetic structural unit were
designed. In order to ensure the same contact area, the sum
of the long axis and the short axis is set to 2mm. As shown in
Figure 2. (a) tensile test sence (b) strain-stress curve. Fig. 5, the values of long axis of the ellipses include 1.3mm,

189

Authorized licensed use limited to: University of Canberra. Downloaded on May 22,2021 at 18:58:08 UTC from IEEE Xplore. Restrictions apply.
1.5mm, 1.7mm, while the values of short axis of the ellipses overall deformation is increased form 0.3748mm to
include 0.7mm, 0.5mm, 0.3mm. 0.4417mm, which means larger deformation offering lower
The three units were imported into Abaqus 6.14, we gave modulus and better energy absorption.
a load of 0.2Mpa and obtained the Poisson's ratio of the units
and the deformation of the upper surface. Due to the
axisymmetric characteristics of the designed units, the strain
variables in the vertical direction and the horizontal direction
were respectively measured, and the ratio of the two values
was the negative poisson ratio of the unit. From the Table II,
we can conclude that the third unit has a low young’s
modulus and large absolute value of the Poisson's ratio.
According to the results of related literature, the absolute
value of Poisson's ratio is positively correlated with the
energy absorption performance [12]. Hence, the third auxetic
structure was selected to form the soft area.

Figure 4. (a) rotating square structures (b) side view of units.

Figure 6. (a) auxetic structure insole (b) flat structure insole.

Figure 5. Deformation of the auxetic structural units III. EXPERIMENTS


(a)a=1.3mm,b=0.7mm (b) a=1.5mm, b=0.5mm (c)a=1.7mm,b=0.3mm.
In order to verify the plantar pressure reduction effect of
the support area, we printed arch support sample and flat
TABLE II. MECHANICAL PROPERTY OF AUXETIC STRUCTURES sample. The volunteer was in a standing position with
Mechanical property Unit1 Unit2 Unit3 pressure sensors under the first metatarsal and the heel
Ellipse long axis (mm) 1.3 1.5 1.7 region. The support area and flat area were placed under the
Ellipse short axis(mm) 0.7 0.5 0.3 arch of the foot respectively in Fig. 7. The resistance of the
Poisson rate -0.1960 -0.2005 -0.2368 sensor is inversely proportional to the plantar pressure,
Upper surface 0.43 0.74 0.96
deformation(mm)
combined with an external circuit to output a voltage signal.
Internal energy change(mJ) 0.1742 0.2911 0.3652 The values of voltage reflect the plantar pressure variation.
Young’s Modulus(Mpa) 2.79 1.62 1.25 As shown in Fig.8, a hundred consecutive points were
collected. After calculation, the average voltage values of the
A partial stress analysis of the rearfoot region of soft area rearfoot and forefoot with support area are 0.2403V and
was conducted. The average plantar pressure of an adult is 0.1115V, and the average voltage values of the rearfoot and
0.2Mpa, and 0.2Mpa pressure is set on the upper surface of forefoot with flat area are 0.3346V and 0.1519V respectively.
the insole while the bottom surface of the insole was fixed to This experiment showed that the arch support area results in
withstand the pressure. Due to the soft material, deformation the reduction of plantar pressure of the forefoot and rearfoot
of the insole will inevitably occur after applying force in Fig. by 30%.
6(a). The average deformation of the auxetic structural units’ This article also explored the scene of wearing orthotic
upper surface is 0.4417mm. Simulation results showed that insoles with sensors during walking. The state of foot in a
when many negative Poisson ratio units are connected, the gait cycle can be divided into four condition: heel strike, full
whole structure will become stronger and the upper surface contact, heel rise and toe off the ground. Five membrane
deformation will be reduced from 0.96mm to 0.4417mm. pressure sensors were installed on the insole of the right foot,
Compared with the ordinary flat insoles in Fig.6(b), the which were located on inside forefoot, outside forefoot, arch

190

Authorized licensed use limited to: University of Canberra. Downloaded on May 22,2021 at 18:58:08 UTC from IEEE Xplore. Restrictions apply.
support, inside rearfoot and outside rearfoot (Fig. 9), which
did not affect the normal walking for small thickness. The
volunteer performed the test on an indoor treadmill at a
walking speed of 3km/h.

Figure 7. (a) support area (b) flat area.

Figure 10. Sensors’ voltage change values during walking.

IV. CONCLUSIONS
In this study, a novel structure foot orthosis for diabetic
foot has been proposed. The insole is based on honeycomb
structure and auxetic structure for optimizing the stress
distribution. 3D scanning technology and 3D printing
technology are employed to manufacturing the novel porous
insole. Simulation results show that the soft area enhances
larger deformation than common flat structure by 18% under
pressure. The standing experiments show that the support
area reduces the pressure of the forefoot region and rearfoot
region by approximately 30%. We also put wearable sensors
Figure 8. Sensors’ voltage change values during standing. on the printed insoles to explore the possibility of collecting
natural data in daily life. In the future, Novel structures and
It can be seen from the Fig.10 that the values of five embedded sensors will be applied to the orthotic insole, and
sensors clearly reflect the contact state of the foot with the better wearable systems will be available for a variety of
ground during walking. Here a gait cycle is selected in the individuals. We conclude that customized insole is a very
picture for analysis: the pressure values on the inside rearfoot promising field in smart healthcare for specific patients.
and outside rearfoot gradually increase from zero, indicating
that the right foot has begun to touch the ground. Then there REFERENCES
appears the pressure value of the arch support, indicating that [1] N. Singh, D. G. Armstrong and B. A. Lipsky, "Preventing Foot
the arch support helps sharing the pressure. Immediately the Ulcers in Patients With Diabetes," JAMA : the journal of the
American Medical Association, vol. 293, pp. 217-228, 2005-01-01
sensors of the inside forefoot and outside forefoot appear 2005.
peak value, which means the right foot is about to get off the [2] F. S. Chiwanga and M. A. Njelekela, "Diabetic foot: prevalence,
ground. Finally, the values of above pressure sensor decrease knowledge, and foot self-care practices among diabetic patients in
sequentially and return to zero, which means that the foot is Dar es Salaam, Tanzania – a cross-sectional study," Journal of Foot
suspended in the swing phase and a complete gait cycle and Ankle Research, vol. 8, 2015.
movement is completed at this time. Therefore, the insole [3] Z. Taha, M. S. Norman, S. F. S. Omar, and E. Suwarganda, "A Finite
can provide arch support and help in the recognition of the Element Analysis of a Human Foot Model to Simulate Neutral
Standing on Ground," Procedia Engineering, vol. 147, pp. 240-245,
support phase and the swing phase in a gait cycle. 2016.
[4] J. T. Cheung and M. Zhang, "Parametric design of pressure-relieving
foot orthosis using statistics-based finite element method," Medical
Engineering & Physics, vol. 30, pp. 269-277, 2008.
[5] S. Goske, A. Erdemir, M. Petre, S. Budhabhatti, and P. R. Cavanagh,
"Reduction of plantar heel pressures: Insole design using finite
element analysis," Journal of Biomechanics, vol. 39, pp. 2363-2370,
2006.
[6] M. Hajizadeh, G. Desmyttere, J. Carmona, J. Bleau, and M. Begon,
"Can foot orthoses impose different gait features based on
geometrical design in healthy subjects? A systematic review and
meta-analysis," The Foot, vol. 42, p. 101646, 2020.
Figure 9. Five pressure sensor placement.

191

Authorized licensed use limited to: University of Canberra. Downloaded on May 22,2021 at 18:58:08 UTC from IEEE Xplore. Restrictions apply.
[7] L. Tang, L. Wang, W. Bao, S. Zhu, D. Li, N. Zhao, and C. Liu, sensing: Proof of concept and relationship with activity," Medical
"Functional gradient structural design of customized diabetic insoles," Engineering & Physics, vol. 36, pp. 9-15, 2014.
Journal of the Mechanical Behavior of Biomedical Materials, vol. 94, [10] J. A. Ramirez-Bautista, J. A. Huerta-Ruelas, S. L. Chaparro-Cardenas,
pp. 279-287, 2019. and A. Hernandez-Zavala, "A Review in Detection and Monitoring
[8] A. Peker, L. Aydin, S. Kucuk, G. Ozkoc, B. Cetinarslan, Z. Canturk, Gait Disorders Using In-Shoe Plantar Measurement Systems," IEEE
and A. Selek, "Additive manufacturing and biomechanical validation Reviews in Biomedical Engineering, vol. 10, pp. 299-309, 2017.
of a patient ‐ specific diabetic insole," Polymers for Advanced [11] J. Shen, S. Zhou, X. Huang, and Y. M. Xie, "Simple cubic three-
Technologies, vol. 31, pp. 988-996, 2020. dimensional auxetic metamaterials," physica status solidi (b), vol. 251,
[9] S. Telfer, J. Munguia, J. Pallari, K. Dalgarno, M. Steultjens, and J. pp. 1515-1522, 2014.
Woodburn, "Personalized foot orthoses with embedded temperature [12] K. E. Evans, "Auxetic Polymers-A new range of materials,"
Endeavour, vol. 15, pp. 170-174, 1991.

192

Authorized licensed use limited to: University of Canberra. Downloaded on May 22,2021 at 18:58:08 UTC from IEEE Xplore. Restrictions apply.

You might also like