Project Description

W.L. Gore & Associates currently only possess healthy blood vessels to test and study the deployment of their endoprosthesis. Creating a diseased vessel, with the ability to increase/decrease the severity of the diseased occlusion, is a worthwhile endeavor when trying to study the deployment of their stents.
The following is the original project description provided by the sponsor:

“The scope of this project is to design, build, and test a replicable model of calcified lesions in the Peripheral Arterial System for deployment of peripheral vascular interventional devices under simulated use conditions, using non-biologic materials.”

Constraints

ANSI and OSHA standards need to be met and adhered to for all aspects of the design. The device will need to be able to function safely at temperatures and pressures commonly seen in the human body. The lesion must be an accurate simulation of calcification that takes place in the blood vessel without the use of biological materials.

DISCLAIMER

This report was prepared by students as part of a university course requirement. While considerable effort has been put into the project, it is not the work of licensed engineers and has not undergone the extensive verification that is common in the profession. The information, data, conclusions, and content of this report should not be relied on or utilized without thorough, independent testing and verification. University faculty members may have been associated with this project as advisors, sponsors, or course instructors, but as such they are not responsible for the accuracy of results or conclusions.

Engineering Requirements

Table 1 - Summary of Engineering Requirement Values
Requirement	Units	Target	Tolerance	Range
Transparent	%	100	-20	80-100
Lesion Durometer	Shore A	85	± 10	75-95
Lesion Adhesion	N/m	20	± 15	5-71
Lesion Length	cm	15	± 1	3-27
Vessel Diameter	mm	7	± 1	4-12
Lesion Thickness	mm	6	± 1	4-6
Degree of Occlusion	%	75	± 10	50-95
Vessel Length	cm	+10 per side	± 1	15-40
Cost	$	3000	N/A	<3000
ANSI Standards	N/A	Meets All	N/A	N/A
OSHA Standards	N/A	Meets all	N/A	N/A
Body Temperature (LTE)	°C	37	± 12	25-49
Blood Pressure (LTE)	mPa	19	± 9	10-28

Needs

Gore requires a simple manufacturable model of a calcified blood vessel in order to accurately test stents for the Peripheral Arterial System. The model must allow a transperent view such that the stent can be seen as it is deployed. Most importantly the model must accurately simulate a calcified lession. The Engineering Requirements table covers the target values that will accurately replicate a lession.