By Ronald Bush, MD, FACS

I have been asked to comment on the so called patents on procedures and also on the validity of the patents that both Diomed and VNUS obtained for endovenous thermal ablation.

The basic theory behind the Diomed patent that was obtained from five physicians including Dr. Robert Min and Dr. Luis Navarro was that laser contact to the endoluminal vein surface is essential for effective damage of the vein causing eventual thrombosis and scarring.

This statement means that laser damage is done by thermal conduction. In our previously reported studies, as well as new papers that have been submitted, this theory can be unquestionably denied.

Without going into mathematical models and in-depth histological discussions, which are beyond the scope of this commentary, several facts can be addressed.

1.     Using Fourniers analysis and combining this with the work of Van Genert and Welch, it is clear that heat conduction plays a minor role in tissue damage. Almost all the damage is by convection (steam bubbles). Using the formula for a cylinder without ends, (the saphenous vein,) compute the surface area. Next, using the bio-heat conduction equation, the amount of heat absorption by conductive response can be calculated. The result can vary according to numerous variables, but is less than 10 percent by volume in all situations. Hence, fiber contact is not essential.

2.    As far as the tumescent solution for this procedure being part of the patent, this is not warranted. Tumescent technique for saphenous procedures was first described in an article by myself and in another article by Dr. Probestle before the year 2000.

Many physicians have brought improved techniques built upon the work of previous investigators.

Dr. Jeffrey Klein chose not to patent a technique (tumescent anesthesia); and those surgeons responsible for laporscopic choleycystectomy did not patent their technique. When a new technique occurs that is based on the work of others, it is unethical and arrogant to profit from such greedy behavior.  Both the tumescent technique and thermal ablation of the saphenous vein had been described previously – and not by the patent holders.

Companies that try to monopolize a certain field based on patents that are not new and on innovative works should not be rewarded by physicians using their products. Physicians and surgeons who would do this should not be invited to participate in future scientific presentations because obviously their opinions are not based on scientific data but on monetary reward.

Most disturbing is that this greed increases the cost to physicians and, therefore, their patients.  This unethical process should cease. VTN

Ronald Bush, MD, FACS,  was one of the first vascular surgeons to practice venous surgery only starting in 1995.  He is board certified in general surgery, vascular surgery and thoracic surgery. He has published many articles in peer-reviewed journals on topics ranging from lung cancer, arterial disease and numerous publications on venous disease.  He also holds patents on surgical instruments. Surgeons from throughout the U.S and the world have been trained by Dr. Bush; at last count, more than 500 physicians have visited his clinic in Dayton, Ohio, and he has conducted seminars on venous surgery for more than 12 years.  He is a member of Vein Affiliates and is in charge of continuing education for this all surgeon group. He serves on the Vein Therapy News Editorial Advisory Board.