1

Coronary Artery Drug-Eluting Stent:

Mechanical Designs to Treat
Post-Stent Thrombosis
Prepared for: Rebecca Kandell, Computer Design Leader,
BMES Drug-Eluting Stent Design Team
Prepared by: Elysa F. Campo
Date submitted: 7 March 2016

Table of Contents
Table of Figures ______________________________________________

Introduction ________________________________________________
Clientele
Background
Solutions
Criteria

Methods ____________________________________________________
Interviews
Rebecca Kandell
Scholarly Articles
Stent thrombosis: an overview.
Drug-Eluting Stent Design is a Determinant of Drug Concentration at
the Endothelial Cell Surface.
Coronary Artery Stents: identification and evaluation.
Coronary stents: historical development, current status and future
directions.
Integrity Coronary Stent System: Medtronic Website.

Results __________________________________________________
Interviews
Rebecca Kandell
Scholarly Articles
Stent thrombosis: an overview.
Drug-Eluting Stent Design is a Determinant of Drug Concentration at
the Endothelial Cell Surface.
Coronary Artery Stents: identification and evaluation.
Coronary stents: historical development, current status and future
directions.
Integrity Coronary Stent System: Medtronic Website.

Conclusions _______________________________________________
Contact with artery wall
Interruption of blood flow
Flexibility

Recommendation __________________________________________

Glossary _________________________________________________

References _______________________________________________

10

Table of Figures
Figure 1 ____________________________________________________
Diagram of a stent deployment within an artery.
Figure 2 ____________________________________________________
Pictorial representations of the oval and the narrow diamond designs.
Figure 3 ____________________________________________________
Integrity Stent by Medtronic.
Figure 4 ____________________________________________________
Palmaz-Schatz 153/154 Stent by Cordis.
Figure 5 ____________________________________________________
Representation of shear stress on arterial wall.
Figure 6 ____________________________________________________
The Integrity stent compared with a competitors stent design.

4
5
5
5
7
7

Introduction
In this report, I will analyze different stent designs and decide which model is the best to achieve
our goal of minimizing and treating post-stent thrombosis. This topic is significant because
coronary artery disease (CAD) is the leading cause of morbidity and mortality in the world
[1]and stents are very viable methods of treatment for heart disease. However, post-stent
thrombosis may totally undermine the progress which the average stent would make in treating
a closed artery. As of yet, it does not have any mainstream solutions or treatments.
Clientele
I am part of a Stent Design Team which is a branch of the Cal Poly Biomedical Engineering Society, and we are endeavoring to create a drug-eluting stent to treat post-stent thrombosis. I am
seeking to determine which mechanical design of stent would best suit the needs of the patient
and the specifications of the stent itself.
My client is Rebecca Kandell, a third-year Biomedical Engineering student who leads the Stent
Design Team. She is in charge of the computer design portion of the project, which means she
leads the group of students interested in designing the structure of the stent. With luck, my findings will help us design a workable model that we can submit to testing and possibly to competitions [2].
Background
As previously mentioned, our project seeks to treat post-stent thrombosis. The form of heart
disease initially treated by the stent is thrombosis. This is when one or more blood clots (one
thrombus or many thrombi) develop in a specific place in an artery. When left alone, the thrombus might grow and prevent blood from reaching certain parts of the body, depriving them of
nutrients and oxygen. Sometimes, a thrombus may break loose and travel through the blood
stream (now called an embolus), and it can lodge and cause similar damage in different parts of
the body. For instance, it could block a vessel in the brain, which would cause a stroke. The average change of this happening in a patient with a stent is 0.6-4% [3].
A stent is a small wire contraption that resembles a tube. When an artery is blocked by
thrombi or inflammation, a stent is inserted by
making a small cut in the thigh to feed a guidewire with a balloon catheter through the femoral artery, into the circulatory system up to the
heart, where blood clots frequently form. The
balloon is then expanded to deploy the stent,
and the guidewire and balloon are removed
from the body. (Refer to Figure 1 for reference.)
Though this treatment of thrombosis is one of
the most effective and least traumatic of those
currently available, sometimes the stent itself
Figure 1: Diagram of stent deployment within an
will cause irritation and blood clots in the arartery [4].
tery. This effect is known as post-stent thrombosis. Our stent design team will aim to reduce this effect by a) analyzing the structure, and b)
coating the stent in a drug which will elute into the artery walls. (Note: these are plans for once
the stent structure is actually designed. This report will not discuss drugs.)
Solutions
The two solutions I am considering are as follows:
Oval/Coil Design
The Oval stent design is made by using thin wires of metal to create a long ribbon of

5
sinusoidal waves, which are then coiled in a tubular pattern and fused together [5]. The
design is characterized by the oval-shaped spaces in between the struts. Refer to Figure
2.
For the sake of simplicity, throughout this report, I will study an industry example of this
type of stent, specifically the Integrity Stent System by Medtronic. Refer to Figure 3.
Narrow Diamond/Slotted Tube
The Narrow Diamond stent design is made by cutting a narrow diamond pattern similar
to checkers in the metal tube [6]. The design is characterized by the narrow diamond
spaces in between the struts. Refer to Figure 2.
For the sake of simplicity, throughout this report, I will study an industry example of this
stent, specifically the Palmaz-Schatz 153/154 Stent by Cordis. Refer to Figure 4.

Figure 2: Pictorial representations of the oval and the narrow

diamond designs. Image taken from [6].

Figure 3: Integrity Stent

by Medtronic. Image taken
from [5].

Figure 4: Palmaz-Schatz
153/154 Stent by Cordis.
Image taken from [7].

Criteria
I will study how each of these two stent designs measures up against three main criteria: contact
with the artery wall, minimal disruption of blood flow, and flexibility.
In general, the more contact the stent has with the artery wall, the more irritation and inflammation it can cause [2]. Therefore, for our own stent design, less contact is desirable.
For obvious reasons, minimal disruption of blood flow is a desirable characteristic of a stent.
The reason the stent is being deployed in the first place is to open up the artery and allow good
blood flow. Interrupted blood flow can encourage blood clots [6].
Finally, flexibility in a stent is similarly desirable, as it means less of a chance of a complication
with the stent over time [5].

Methods
Interviews
Rebecca Kandell
Rebecca is the leader of the computer modeling subgroup of the Stent Design Team. She
helped me decide on which factors are the most important to focus on when deciding on
the best mechanical design for the stent.
Scholarly Articles
Stent thrombosis: an overview.
I read this source to get some general information on stent thrombosis, not necessarily
about the stent design but still pertinent.
Drug-Eluting Stent Design is a Determinant of Drug Concentration at the Endothelial
Cell Surface.
This paper takes three different stent designs and compares them, using specific criteria
for what makes a stent the safest and most effective.
Coronary Artery Stents: identification and evaluation.
This paper discusses the history of the stent, desirable qualities and specifications, and
compares and contrasts numerous stent designs by several different companies, including one of the potential solutions, the Palmaz-Schatz Stent.
Coronary stents: historical development, current status and future directions.
This article, as indicated, discusses the historical development, current status, and future
directions of coronary stents. It includes such information as the progression from selfexpanding to balloon-expandable stents, from bare metal stents to drug-eluting stents,
and expected frontiers that stent design might traverse.
Integrity Coronary Stent System: Medtronic Website.
The website for the Integrity describes the product to potential buyers and compares its
deliverability to that of other stents.

Results
Interviews
Rebecca Kandell
I interviewed Rebecca to define the specifications for our project. She told me that in
general, whether or not the stent elutes a drug, minimal contact with the artery wall is
preferable.
At a later time, Rebecca and I met and discussed the parameters of my report. We decided together to limit the report to three important criteria on which to grade the stent designs, and also discussed two designs to compare to each other, the Integrity design and
the Driver design, both by Medtronic. (Note: Upon closer inspection, I realized that the
Integrity and Driver designs were quite similar and both resembled the oval design. I
therefore researched and found a stent design that was different from both of these, the
Palmaz-Schatz, which is a slotted tube/narrow diamond design. For this reason, my report compares the Integrity and the Palmaz-Schatz, and does not discuss the Driver.)
Scholarly Articles
Stent thrombosis: an overview.
I used this source so that I could have enough background information to properly introduce post-stent thrombosis. It turns out that it is quite difficult to ascertain the percentage of occurrence of post-stent thrombosis but the paper combined multiple studies and
claimed that 0.6-4% of stent procedures result in post-stent thrombosis.

Drug-Eluting Stent Design is a Determinant of Drug Concentration at the Endothelial

Cell Surface.
This article described how the different designs of stent caused different amounts of
shear stress, or pressure caused by fluid flow, on the artery wall. The following Figure 5
was particularly helpful in understanding.

Figure 5: Representation of shear stress on arterial wall.

Leftshear stress on the artery wall with an Oval stent design.
Rightshear stress on the artery wall with a Narrow Diamond stent design.
Blues indicate low shear stress; oranges and reds indicate high shear stress.
Image taken from [6].

As pictured in Figure 5, the Narrow Diamond design has more spots of high shear stress,
indicated by the red color. However, the Oval design has more blues and greens, indicating less shear stress and less obstruction of blood flow.
Coronary Artery Stents: identification and evaluation.
Rebecca and I read this article together to decide on two diverse stent designs. We did
look through all of them, and even though together we came to a different conclusion explained previously, I found the Palmaz-Schatz in this paper and decided to use it as an
example of a narrow diamond/slotted tube design for my report. In their description of
the Palmaz-Schatz stent, the writers noted the strength of the stent design, saying that it
required 1.26 atm of pressure before collapsing.
Coronary stents: historical development, current status and future directions.
This article discusses the significance of stents in modern-day health care. It also notes
that the Palmaz-Schatz was the very first stent approved by the Food and Drug Administration in the United States.
Integrity Coronary Stent System: Medtronic Website.
The website for the Integrity had a very helpful infographic which compared the slotted
tube design to the coil design. Refer to Figure 6.
An artery is rarely exactly straight, so if a
stent is implanted, it is expected to bend
to conform to the artery shape. The image shows how the Integrity distributes
the stress of bending around the whole
stent so that one part does not break,
similar to how skyscrapers are retrofitted
to sway during earthquakes. The Multilink Vision type of stent which is compared to the Integrity in the image is held
together in the same way as a narrow diFigure 6: The Integrity stent compared with a
amond/slotted tube design, but demoncompetitors stent design. Image taken from [5].

8
strates limited flexibility and more brittleness.

Conclusions

I have employed a decision matrix to summarize and to organize the criteria and how each stent
design fits them. Following the matrix, I will discuss my grading in more detail.
Oval/Coil Design
Contact with artery wall
(minimal is desirable)
Interruption of blood flow
(minimal is desirable)
Flexibility
(maximal is desirable)

Less contact with artery wall

Narrow Diamond/Slotted
Tube Design
More contact with artery wall

Less interruption of blood

flow
High flexibility

Greater interruption of blood

flow
Low flexibility

Contact with artery wall

The oval design seems to have less contact with the artery wall than does the narrow diamond
design. I can ascertain this by inspection: referring to Figures 2 (page 5), there is more material
that makes up the narrow diamond stent design for any given unit of length than the oval design. As a result, in the case of the narrow diamond design, more foreign material is in contact
with the artery wall, which can cause inflammation and irritation. The stents goal is to be calmly
accepted into the inner surface of the artery wall, and irritation is not conducive to this goal.
Therefore, the oval design wins in this criterion.
Interruption of blood flow
As shown in Figure 5, the narrow diamond design, when implanted, results in more shear stress
on the arterial wall, putting the artery in danger of rupturing, which would cause internal bleeding and potentially disastrous consequences. Also, the greater interruption of blood flow could
cause platelets to clot, leading to the very thrombi that the stent is designed to prevent and to
discourage. The oval design, however, shows low levels of shear stress on the artery wall, resulting in a calmer environment for the stent to integrate with the body. The oval design also
demonstrates less of a chance of blood clots forming. So, the oval design is triumphant in this
category as well.
Flexibility
According to the Integrity description webpage on Medtronics website, the Integrity (this reports industry example of an oval design stent) demonstrates greater ability to bend within the
body than its competitors. The Palmaz-Schatz, through reportedly a very strong stent, likely is
not able to bend in the same way as the Integrity due to its strength. Flexibility is important
within the body so that the stent can conform to the arterys shape and avoid causing complications that could lead to internal bleeding or additional clotting. Again, the oval design is proven
better than the narrow diamond design.

Recommendation
I am recommending the Oval design of stent for Cal Poly Biomedical Engineering Societys Stent
Design Project of a drug-eluting stent. Next we should research SolidWorks designs of oval-link
stents, decide on a material that would allow for consistent drug-elution, and continue the project from there.

Glossary
Artery: a blood vessel that carries oxygenated blood from the heart out to other parts of the
body. (Note: within this paper, I will mostly be referring to coronary arteries, those found in the
heart.)
Balloon catheter: a long, thin device with a balloon and stent on the end, fed through the guide
wire up to the location of stent deployment, where the balloon is inflated and the stent is deployed.
Embolus: a blood clot that is moving freely through ones arteries.
Femoral artery: a large artery located in the inner thigh.
Guidewire: a medical device inserted through the femoral artery before inserting the catheter,
guides the catheter through the arteries to the location of stent deployment.
Shear stress: pressure exerted by a fluid on the vessel through which it travels, ie. blood through
an artery.
Stent: a small, cylindrical medical device that is installed in a coronary artery, which holds the
artery open and allows for proper blood flow. Can be either bare-metal or drug-eluting.
Thrombosis: a medical condition where one has a thrombus in ones artery.
Thrombus: a stationary blood clot forming in ones artery.

10

References
[1] J. Iqbal, J. Gunn, and P. W. Serruys, Coronary stents: historical development, current status
and future directions, British Medical Bulletin, vol. 106, pp. 193-211, Mar. 2013.
[2] E. Campo, Interview with Rebecca Kandell, California Polytechnic State University, San
Luis Obispo, CA, 2016.
[3] M. P. Centemero and J. R. Stadler, Stent thrombosis: an overview, Expert Review of Cardiovascular Therapy, vol. 10, no. 5, p. 599, May 2012.
[4] [Online]. Available: http://thecardiacinstitute.com/wp-content/uploads/2015/03/stent.jpg.
Accessed : Mar. 1, 2016.
[5] Integrity Coronary Stent System, Medtronic.com N.p., 2016. Web. 6 Mar. 2016.
[6] J. Butany, K. Carmichael, S. W. Leong, and M. J. Collins, Coronary artery stents: identification and evaluation, Journal of Clinical Pathology, vol. 58, no. 8, pp.95-804, Jul. 2005.
2016. Print.
[7] T. Seo, A. Lafont, S. Y. Choi, and A. I. Barakat, Drug-Eluting Stent Design is a Determinant
of Drug Concentration at the Endothelial Cell Surface, Annals of Biomedical Engineering, vol. 44, no. 2, p. 302, Feb. 2016.