Graduation Year

2014

Document Type

Thesis

Degree

M.S.B.E.

Degree Name

MS in Biomedical Engineering (M.S.B.E.)

Degree Granting Department

Chemical and Biomedical Engineering

Major Professor

Karl A. Illig, M.D.

Co-Major Professor

Venkat R. Bhethanabotla, Ph.D.

Committee Member

Robert D. Frisina Jr., Ph.D.

Keywords

Adhesive, Directional Glidewire, Hydrophilic, Medical Device Design, Prototype

Abstract

Guidewires have been used in many operating rooms by vascular surgeons to assist them in positioning and maneuvering through a tortuous stenosis or lesion to a desired location, and to be used as a guide for the implantation of a catheter. Surgeons are tasked with having to insert a guidewire inside a small cavity, which requires a high level of skill and patience. The insertion of the guide wire is controlled by a torque device, which allows a surgeon to advance, rotate and grip the wet hydrophilic coating of the guidewire. Despite its many advantages, the torque device does, in fact, give rise to many time consuming issues that results in delays to the surgical procedure. One main problem in the use of the torque device is that it is introduced through the proximal end of the guidewire. Therefore, it requires the assistance of another individual, the

surgical technician, to advance the torque device from the furthest point away from the patient. Once the torque device is in position, it is up to the surgeon to attempt to control the tightening, advancing and loosening of the device all with one hand. The other, free hand is used as a placement hand to secure the positioning of the guidewire within the patient. Another issue arises in the removal of the torque device, which must be loosened with one hand and slid off the same end it was introduced, often resulting in the unwanted ejection of the guide wire tip from within the patient's body. The process must then commence from the start, resulting in loss of valuable time, and be repeated until the distal tip of the guidewire is secure in the desired location and the catheter can now be introduced.

The main purpose of this research is to investigate, design, and develop a new guidewire torque device to facilitate in a more controlled manipulation of a guidewire by vascular surgeons. Through in-depth interviews with both surgeons and surgical residents alike, direct observational time in the vascular surgery OR (operating room), and I obtained knowledge used as a design basis for the development of the product. For example, observations of relevant medical procedures were also accomplished at Tampa General Hospital to establish a basis for the design,and to assess current vascular surgery medical procedures. Initial design concepts where created using SolidWorks CAD software. After a period of researching and understanding user needs, an assortment of non-slip adhesives where found to be a viable solution to the problem. A characterization analysis was done on the highest rated non-slip adhesive to further define design parameters, and pave the way for FDA approval and product commercialization.

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