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Design Considerations For A Clinical XeC1 Excimer Laser Angioplasty System

Laser ablation and removal of intravascular plaque has long been a goal of physicians and physicists as an alternative treatment for coronary and peripheral artery disease. Early application of cw free light beam visible and infrared lasers such as argon ion or Nd:YAG lasers for this application were plagued by thermal side effects of the ablation process. Specifically, imprecise control of the boundary tissue injury produced by the deep penetration depth of the laser beam gave rise to early reclosure of the vessel due to the thermal nature of the ablation process. Pulsed ultraviolet laser free beam ablation of atherosclerotic plaque, however, does not produce thermal effects, cuts tissue precisely leaving a smooth wall and can ablate hard calcific lesions. We have chosen to develop a XeC1 excimer laser-fiberoptic delivery system for the clinical application of laser angioplasty based on achieving the desired therapeutic results for a laser revascularization procedure. Four major engineering design issues must be considered in order to produce a successful clinical laser angioplasty product. These engineering issues are: 1) Functional clinical engineering, 2) Regulatory design issues, 3) Hospital facility and user requirements, and 4) Economic issues for the manufacturer, the hospital and the patient.