- Email: fradkin@netvision.net.il / elifradkin@gmail.com
- Phone: +972544720827 / +972544427255
Cardeovis Technologies Ltd. invented revolutionary new Surgeon Laser Machine (SLM), new surgical device, procedure and technology to improve the quality of operation and to improve quality of life of the cardiac patients after the operation.
SLM is a new surgical instrument needed in every operation room around the world. SLM can be used not only for cardiac operations.
Our mission is to improve life quality of millions and millions people suffering from cardiac and other diseases. The way to carry out our mission is to design and produce SLM devices, to prove the new technology advantages and to design new medical accessories needed for such kind of operations.
Coronary artery bypass surgery (CABG) is one of the most prevalent surgical procedures performed. Only in USA more than 700,000 patients requiring coronary revascularization underwent CABG surgery. The surgery itself is relatively complex with multiple decision points to be carefully crossed, starting with the midline sternotomy which is the most commonly incision used by cardiac surgeons. It provides the most advantageous access for most cardiac operations because it can be quickly performed and allows for surgical exploration of the thoracic cavity. It is also useful for accessing anterior mediastinal lesions and for bilateral pulmonary procedures.
Midline sternotomy is one of the most critical phases of the operation mainly because of the potential for injury to the underlying organs or blood vessels. Therefore, during sternotomy surgeons tend to ask the anesthesiologist to deflate the lungs and to minimize ventilation in order to avoid displacement of the heart and lungs towards the operative incision field and to minimize the potential injury of these organs.
The operative approach of sternotomy begins with vertical skin incision made from below the suprasternal notch towards the half way between the xiphpoid process to the ombelicum. Subsequently the sternum itself is longitudinally dissected with the use of an oscillary cast cutter and it is highly important to inspect all the dissected surfaces. The incision itself may have unlimited consequences both peri and postoperatively and meticulous incision is mandatory to avoid troublesome long run complications.
Unfortunately, sternal and chest wall pain after median sternotomy have a debilitating prolonged effect on a patient's recovery and long term functional status after operation. In fact, the main limitation to activity after open heart surgery is healing of the sternum which may take up to 12 weeks following conventional bypass surgery. Complication rate for midline sternotomy range from 0.5% to 5% and mortality rates from these complications ranges from 7% to 68% according to various reports. Sternal wound infections dramatically increase morbidity, mortality and cost, requiring in certain circumstances a complete surgical removal of the sternum and plastic surgical reconstruction of the chest wall. In large series of patients, a 9% incidence of sternal fracture was observed. This was mainly associated with extensive sternal devascularization owing to bilateral internal thoracic artery harvesting. Also, the need for re-sternotomy incision has increased over the last two decades since an increasing number of patients are undergoing a second and even third coronary revascularization or other surgical procedures which required open thoracotomy.
The sternum is an elongated flattened bone with relatively low density. It composed of three main fused parts in the centre of the chest that articulates with and provides support for the clavicles and for the ribs. Its average length is 17 cm and it is rather greater in the male than in the female. Width is 30-40 mm and thickness 10-11 mm. It is composed of highly vascular cancellous tissue covered by a thin cortex layer of compact bone. The mean distance from the sternum to the most medial vessel is 1 cm of either the right or the left side. Sternal size does not affect chest stability unless it is related to the patient's body weight which is a widely known risk factor for sternal instability detected in 7% of patients undergoing midian sternotomy.
Midian sternotomy from the xiphoid to the manubrium of the sternum carries a substantial risk of infection, injury and healing especially among diabetic patients, obese, patients with chronic illness including COPD, PVD or when both mammary arteries are used as arterial conduits for revascularization. Serious sternal wound infection and dehiscence and consequent instability of the chest closure represents the most feared complication, facilitating tissue infection, osteomyelitis and mediastinitis. It occurred in almost 2% of patients undergoing midsternotomy. In this context, the depth of incision is crucial and it is often difficult to determine the cut off edge of the incision. Several techniques like upward traction of the sternum are being used to limit the depth of penetration of the oscillary saw. However, it has been suggested that an optical evaluation like multidetector CT (MDCT) with three-dimensional volume reconstruction can be useful for surgical planning, giving rise to a "road map" for the surgeon, providing anatomic valuable information with respect to the adjacent mediastinal structures and the surrounding pericardium and vasculature.
Conventional closure of the sternum at the end of the operation is accomplished by reapproximation of the two sternal halves and the use of four to six stainless steel parasternal sutures, the ends of these sutures are securely twisted and buried in the sternal tissue. The sternal wires are a common site of post operative bleeding and consequently for surgical re-exploration encountered in up to 5% in large series of patients, as well as a source for infection. Bleeding tends to occur on the internal site of the sternum into the thoracic cavity. Titanium plates and stainless steal coils or cables have been tested in substitution of the traditional wires in an effort to improve postoperative sternal stability.
The sternum has a three-dimensional structure and closure of the sternum should be as meticulous as the opening. The encircling wires applied to retain the two dissected parts of the sternum in an effort to restore the chest wall and the anatomic and functional integrity of the sternum, minimizing chest discomfort and disability. Nevertheless, all these potential hazards set the stage for an alternative surgical access rather than mid sternotomy. The minimal invasive bypass procedure is one of the options adopted by the cardiac surgeons to tackle and to spare the problematic issues associated with mid sternotomy as described.
Laser is a generation of light, based on the stimulated emission of radiation from the active medium of the laser. The active medium must be in the state of the inversion of electron population reached by pumping the energy from the outside. Lasers can be divided according to the active medium (solid, liquid, gas) or to the manner of emission (continuous or pulsed waves).
Lasers are widely used in medicine and the effect on living organs depends on its wave length, intensity and shape (continuous or pulsed). In the visible range, thermal effects are due to absorption of the radiation where lasers with longer wavelength can penetrate deeper.
Lasers for medicine use were traditionally classified into two groups: Lasers with higher output (>500 mW) for surgical interventions and lasers with lower output defined as soft lasers. Using the laser as a surgery tool, its advantage consists of its accuracy. Packing all the lasers punch into one wavelength allows high selectivity of an absorbing target serving as an optical lancet cutting with no tissue contact. The tissue itself which does not have to be touched is evaporated, the "broken" vessels are coagulated, the cut does not bleed and no blood loss occurs. The lasers most frequently used are infrared range including gas CO2 laser or solid Nd: YAG lasers. The advantage of using lasers in surgery stems largely from the fact that a laser light can be focused to size of the head of pin. Laser fibers can reach inaccessible anatomic places, often without incisions.
Application of laser technology in cardiothoracic surgery began in 1973 with the use of CO2 laser to ablate benign space occupied lesions, first benign tumors and later on malignant obstructive tumors of the tracheobronchial tree. The Nd-YAG
laser was extensively used in bronchology with its superior hemostatic biological qualities. Lasers were then applied to seal lung tissue, resection of pulmonary nodules and metastatic lesions.
In the Cardiology field, lasers were used for transmyocardial revascularization (TMR) in cardiac patients suffering from angina with no option for revascularization, either surgical or by balloon angioplasty. Lasers in these patients are used to create small channels through the tissue muscle of the left ventricle in an effort to improve perfusion of the heart muscle and to relieve symptoms of angina.
A prototype fiber photo-catheter for surgical treatment of atrial fibrillation with laser radiation has been recently used to make continuous photocoagulation lesions for effective Maze procedure treatments as an alternative for the conventional radiofrequency ablation surgical procedure.
New experimental application is a bipolar Nd-YAG laser. This was examined for a venous dissection and introduced for the vein graft harvesting in patients undergoing coronary artery bypass graft surgery.
Excimer laser was extensively used in the early-mid nineties as an adjunctive tool in percutaneous coronary angioplasty, treating unfavorable rigid complex calcified obstructive coronary lesions including aorto-ostial lesions where conventional interventional PTCA techniques failed to provide fair angiographic and clinical results. Excimer laser was also used for intracardiac pacemaker lead extraction, releasing the lead from the encapsulating fibrotic tissue.