Fabrication and analysis of

biodegradable cardiovascular stent using

thermo induced Poly(DL-lactide) shape
memory polymer by FDM

VIKAS P
LOKESHWAR R
MANOJ KUMAR S
 ABSTRACT

• The treatment of coronary arterial stenosis (vascular obstruction diseases) can be

performed by the implantation of stents during percutaneous transluminal coronary
angioplasty.
• In view of the high in-stent restenosis and stent thrombosis rate of stent implantation
with balloon angioplasty, thermo induced biodegradable vascular stent is prepared by
fused deposition modelling (FDM) from shape memory Poly(DL-lactide) (PDLLA).
• The following tests and analysis are carried out in the fabricated stent : DSC, DMA,
Shape memory effect with time, Biodegradability, Biocompatibility and FEA.
• The combination of biodegradable shape memory PDLLA with personalized
designing of 3D printing provides the vascular stent as a solution for cardiovascular
disease treatment.
INTRODUCTION

• Since the first bare metal stent (BMS) was implanted in the human body in 1986,
the cardiovascular disease treatment entered a new stage.
• To avoid the late thrombosis and the extreme late thrombosis induced by non-
degradable stents, biodegradable stents were invented.
• Biodegradable vascular stents (BVSs) made from biodegradable materials are
designed to disintegrate over several months and to avoid complications from
long-term mucosal irritation or extraction.
• The first polymer stent implanted in humans was the Igaki-Tamai stent made of
PLLA.
INTRODUCTION …

• Regardless of material choice, the mechanical properties, manufacturing process,

and biocompatibility associated with the biodegradable materials remain
challenging.
• Shape memory polymers (SMPs) have the property to store the energy of applied
shapes under different stimuli like temperature, light, electric field, magnetic field,
pH, specific ions, or enzyme and quickly regain their original shapes.
• The aim of this project is to analyses the properties exhibited by PDLLA shape
memory polymers after being fabricated.
MATERIAL

• Poly (D, L-lactide) (PDLLA) is a biodegradable polymer for medical devices and
pharmaceutical applications. It is used to fabricate resorbable medical devices that
degrade over months in physiological conditions.
• Polylactides are one of the easiest and most affordable biodegradable polymers
for medical devices. PDLLA is available commercially and can be purchased for
this project.

SPECIMEN PREPARATION
• The sample can be prepared in the form of strips by dissolving PDLLA in a
suitable solvent and the mixture is finally shaped to desired geometry. We can also
prepare the sample by using a 3D printer.
DESIGNING OF STENT

• The structure of vascular stents has evolved with time to overcome limitations
associated with earlier designs.
• The stent must apply sufficient radial force on the wall of the diseased coronary
artery so that the vessel lumen is restored to a near normal diameter whilst
subsequently scaffolding the vessel and preventing collapse of the artery in the
longer term.
• Desirable performance characteristics include low elastic recoil, conformability,
high visibility and ease of deliverability.
• Thus the desirable stent model is designed by using a suitable software.
FABRICATION

• 3D printing has been used to fabricate low volume and customized products with
complex structures and has been widely utilized to create biomedical and medical
devices.
• The common 3D printing technique used to fabricate intravascular stent is fused
deposition modeling (FDM).
• The processing temperature in FDM is relatively low. As a result, intravascular
stents have been successfully fabricated by FDM.
FABRICATION …

• However, there are some challenges in the traditional FDM based stent fabrication
like complex spatial networked structures, which are composed of some overhang
sections.
• Thus during a traditional FDM, massive support structures must be printed inside
and/or outside the stents simultaneously to hold the deposited overhang sections,
which makes the post treatment complicated and reduces the fabrication
efficiency.
• As a result, a modified FDM with a rotating axle can be used to overcome these
challenges.
ANALYSIS

• DSC
• SHAPE MEMORY EFFECT
• DMA
• VISUAL RECOVERY
• BIODEGRADABILITY
• BIOCOMPATIBILITY
• FEA
 
DIFFERENTIAL SCANNING CALORIMETER

• Differential scanning calorimeter (DSC) is applied to study the transition

temperatures (Tg, Tm & Td) of the sample. The specimen sample is prepared
according to the DSC equipment used.
SHAPE MEMORY EFFECT

1) DYNAMIC MECHANICAL ANALYSER

• The thermal mechanical recovery properties are carried out using DMA in a force
control mode.
• Shape memory performance can be evaluated by the strain fixity ratio (Rf) and the
strain recovery ratio (Rr).
• The strain recovery ratio describes the ability of the stent to memorize its
permanent shape, while the strain fixity ratio describes the ability of switching
segments to fix the mechanical deformation.
SHAPE MEMORY EFFECT…

2)VISUAL RECOVERY
• The shape recovery behaviors are investigated in warm water. The specimen is
prepared according to the requirements.
• The specimen is symmetrically flatted at a deformation ambient in hot water.
Next, a prompt cooling was provided to the temporary flat shape to freeze the
strain.
• Finally, the flat and frozen shape can revert to its initial shape by heating it above
the softening temperature in warm water.
• The whole process is recorded by using a high resolution digital camera. The time
is noted for all the stages of deformation.
BIODEGRADABILITY

• The biodegradability of the specimen is determined by in-vitro degradation test.

• Md and Mo denote the dry weight after degradation and the original weight of the
sample which are obtained from the in vitro degradation test.
• Thus the mass loss percentage is calculated by using Md and Mo. A graph can be
plotted with predetermined intervals and mass loss.
BIOCOMPATIBILITY

• Biomedical stents are usually implanted into blood vessels therefore, good blood
compatibility and no pro-coagulant activity are required. Thus, several tests were
conducted to evaluate the blood compatibility.

1) Platelet Adhesion and Activation:

• The adhesion and activation of platelets on the surface of blood-contacting
biomaterials, which can lead to further coagulation and accelerate thrombosis, are
essential factors in determining their blood compatibility.
• The platelet rich plasma (PRP) obtained from centrifuge is used in determining
the antithrombotic activity of the specimen.
BIOCOMPATIBILITY …

2)Blood Clotting Time:

• To investigate the anticoagulant properties of the blend, the clotting time,
including activated partial thromboplastin time (APTT), prothrombin time (PT)
and thrombin time (TT) were measured.
• APTT and PT are used to evaluate coagulation abnormalities in intrinsic pathways
and extrinsic pathways respectively.
• TT is used to measure the clot formation time for the thrombin-mediated
conversion of fibrinogen into fibrin in platelet poor plasma (PPP).
• A longer clotting time indicates better anticoagulant activity and lower potential
of thrombus generation.
FEA

• The finite element has emerged as a practical tool for evaluating the
biomechanical performance of endovascular stents.
• It aims at estimating the distribution of residual stress, plastic strain, and the
expanded shape under simulation state, such as implanting in arteries.
• The large longitudinal contraction and nonuniform radical expansion would
induce injury to vascular (blood vessels).
• Thus these shortcomings can be prevented by simulating the stent model and
performance.
INNOVATION

• In this project we are introducing the idea of fabricating a stent using PDLLA
shape memory polymer by fused deposition modelling. We are also analyzing the
PDLLA (SMP) by the following tests: DMA, Biodegradability test,
Biocompatibility test and FEA.