A Biodegradable Vascular Coupling Device for End-to-End Anastomosis

Project Summary
The objective of this Phase I SBIR proposal is to demonstrate the feasibility of a device designed to connect
two small vessels together simply and easily and that would replace the hand suturing technique currently
used to connect vessels in microsurgery and macrovascular end to end vascular repair surgeries This
completely biodegradable vascular coupling device VCD being developed by Microsurgical Innovations Inc
MSI Salt Lake City Utah will be applied towards both arteries and veins This approach would reduce the
time required in the surgery suite reduce costs associated with surgery and reduce the likelihood of failure of
the arterial connections by minimizing human error and stenting open the anastomosis
According to the American Society of Plastic Surgeons there were microsurgery procedures in the US
performed by plastic surgeons in This does not include breast microsurgical procedures around
and hand microsurgery procedures Including all of the other subspecialties that perform these types
of procedures neurosurgery orthopedics urology ENT a reasonable estimate of the number of these
surgeries surpasses Current microsurgical techniques require the use of intraoperative magnification
and ultrafine nylon suture m needles to successfully complete the anastomosis These operations
are time consuming min artery and expensive operating room costs of $ s hr Successful
implementation of VCD will expand the pool of surgeons that can perform such operations without
microsurgical specialization thus bringing microsurgery from tertiary to primary care settings and potentially
allow for battlefield surgeries as well
MSI product development is led by Dr Jay Agarwal Assistant Professor of Surgery and Dr Bruce Gale
Associate Professor of Mechanical Engineering at the University of Utah This SBIR project will be directed by
Dr Huizhong Li who has more than years of experience with implantable medical device development MSI
also has access to the additional expertise and facilities at the University of Utah core research facilities for
mechanical testing D printing animal studies histology and imaging at the University of Utah
In this project Microsurgical Innovations will build a series of vascular coupling device designs and test them
first in the lab and then in pigs to determine if they are safe and effective Design modifications will be made
as needed to improve the design of the couplers and to enable inexpensive and efficient manufacturing
The following specific aims detail the goals of Microsurgical Innovations efforts in this Phase I
project
Specific Aim To evaluate the functionality of biodegradable coupling devices ex vivo New prototypes
will be built from PLA using D printing The goal of this task is to evaluate mechanical strength yield
strength of the biodegradable prototypes at simulated physiological conditions in FBS at C Manufacture
mm PLA prototypes of the VCD for testing using arterial and cadaver tissues demonstrate the ability
of the couplers to hold at least psi in of tested devices and demonstrate no noticeable or measurable
loss of function after months in FBS at C
Specific Aim To evaluate the effectiveness and performance of the biodegradable VCD in vivo To
evaluate the functionality of the VCDs in vivo anastomosis procedures will be performed on porcine model for
days and days after refinement using the coupling device and accompanying installation tools Longer
term patency device degradation and foreign body reaction evaluations will be conducted Project Narrative
Vascular anastomoses are an expensive and time consuming surgical procedure performed over
times each year in the US The proposed project would develop a device to rapidly perform the
anastomosis thereby significantly reducing costs and challenges associated with these surgeries The
proposed device will be more effective and efficient than current methods and will therefore significantly
improve medical treatment while reducing costs in the US