The Science

Tubal ligation using direct current (1) and HemWell’s Direct Current Hemorrhoid Ligation Procedure are similar but have different modes of action. The anatomy and physiology of hemorrhoids are complex. Hemorrhoids are not varicose veins but are normal, highly vascular sinusoidal submucosal structures or cushions which generally lie in three major columns, left lateral, right anterior, and right posterior (4)(9). When a hemorrhoid prolapses with symptoms, Graded I through IV, it becomes hemorrhoidal disease commonly referred to as hemorrhoids (9).

Submucosal hemorrhoids are sinusoidal rather than arteries and veins because they lack muscular walls (4)(9). Clinically evident bleeding arises from the perisinusoidal arteries and are therefore arterial in nature (5)(9). Images below are provided by Dr Reed Hogan III. The top image demonstrates a Grade III hemorrhoid prior to treatment. The bottom image is obtained immediately following HemWell Procedure. Direct current ligation with 16 mA at two sites was administered. The second image (obtained immediately following the procedure) demonstrates complete regression, reduction, of the prolapsed hemorrhoid to the submucosa.

The ONLY way immediate reduction of a prolapsed hemorrhoid occurs is by ligating the afferent arteries, the perisinusoidal arteries, with relative preservation of the efferent vessels, the perisinusoidal veins. By eliminating blood inflow to the prolapsed hemorrhoid and preserving its egress, blood leaves the hemorrhoid. As the hemorrhoid decreases in size it reduces to the submucosa. The second image clearly demonstrates its decrease in size and reduction to the submucosa. Also seen is darkening of the mucosa in the region of the previous prolapse. This darkening likely represents the dark submucosal cushion, rich in darker deoxygenated blood following arterial ligation. Without the normal support structure between the cushion and mucosa the darkish tone becomes more apparent (4)(9). Coagulation within the prolapsed hemorrhoid could not produce the immediate, dramatic results seen in the second image. Thrombus retraction of this degree takes days. (6)

Complete understanding of HemWell Procedure’s mode of action requires a brief review of the basic sciences. The HemWell Procedure utilizes a low current (8-16 mA) at 5.5 Volts producing only 0.04-0.08 Watts and is non-thermal. At the time of FDA approval, temperature measurements during a procedure, obtain at the hemorrhoid’s base, revealed no significant temperature change. Electrons flow from the cathode (negative charge) placed at the base of the prolapsed hemorrhoid toward the anode (positive charge) beneath the patient’s left hip. Electrons follow the path of least resistance towards the positively charged anode; similar to water, taking the path of least resistance flows down a hill. Blood, filled with electrolytes, ionized protein, cells, and water is the most electrically conductive tissue in the body. Because of this it becomes the path of least resistance. Electrons pass into the blood of the submucosal cushions and not into the prolapsed hemorrhoid. The prolapsed hemorrhoid is further away from the anode and is not in the current’s path. The electrons enter the vascular cushions, perisinusoidal arteries and veins. Traveling toward the anode electrons leave the vasculature to the tissues surrounding the hip, to the skin and finally complete the circuit at the anode beneath the left hip.

The H2O, Na+, Cl- of the blood in the cushion, perisinusoidal arteries and veins, undergo a chemical reaction producing high concentration of NaOH, -OH, increasing the blood’s pH and produces Hydrogen gas (2)(3). Hydrogen gas, produced in the submucosal vasculature moves upward, just as any gas in a liquid moves upward, entering the prolapsed hemorrhoid. Hydrogen gas is visualized during the HemWell procedure (not pictured above) bubbling from the hemorrhoid’s surface as it passes into the rectum. The gas travels in the opposite direction of electron flow. The high pH in the blood produces a biochemical reaction denaturing protein, causing cellular membrane destruction, with thrombin and fibrin production.

Electrons, electric current, directly act on serum proteins causing protein denaturing, also stimulate thrombin and fibrin production (8)(7). Direct current denatures endothelial cell membrane protein, damaging cells which enhances thrombosis (8). In addition, direct current produces smooth muscle contraction which continues throughout the entire procedure. Smooth muscle is a prominent feature of the afferent circulation, the perisinusoidal arteries. The cushions themselves do not contain a muscular wall (4) and the efferent, perisinusoidal veins contain little to no smooth muscle (4)(9). Vasospasm plays an important role. It is the combination of intense sustained vasospasm of the perisinusoidal arteries, endothelial cell membrane destruction, serum protein denaturing with thrombosis production that causes ligation of the afferent arterioles and arteries. There is relative sparing of the sinuses and efferent vessels because they contain little to no smooth muscle. Ligation of the afferent circulation eliminates hemorrhoidal blood inflow but not its egress. The hemorrhoid quickly reduces to the submucosa as seen in second photo. We believe the vasa vasorum of the larger perisinusoidal arteries are also thrombosed ultimately leading to fibrosis of these larger vessels. Ligation of these larger arteries contributes to the long term, sustained benefits of the HemWell Procedure.

Stephen Goldman MD

Chief Medical Officer, HemWell MD