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Live Tissue Bonding Technology White Papers

WELDING OF PULMONARY TISSUE IN SPONTANEOUS PNEUMOTHORAX OPERATION WITHOUT STAPLING

Olexandr Linchevskyy, Anatoliy Makarov, Vadym Getman

Clinical Hospital for Thoracic Surgery and Pulmonology, Kyiv, Ukraine

Currently, the majority of spontaneous pneumothorax surgeries are performed with wedge apical resection and parietal pleurectomy. The tissue welding method consists of bonding live tissues using a patented radio frequency current method. This process ensures leakproof bonding of tissues. Through mid- 2006 several Ukrainian clinics have performed over 6,000 successful human surgeries using the tissue welding process. Based on the results of previous experimental and clinical studies we undertook surgical research of the tissue welding method for management of spontaneous pneumothorax. Bipolar, radio frequency used in the tissue welding technology current allows ablation of the bullae, which are caused by late-stage emphysema, and allows closure of broncho-pleural communication thus eliminating a condition of air leakage into the chest cavity thus restoring the normal function of the visceral pleura.

We performed a study on the effect of lung tissue welding compared to conventional stapling in surgical management of spontaneous pneumothorax. The following are the results of this study.

All preoperative procedures as well as operative management procedures were done by eight surgeons with different experiences who were not informed of the objective of the study. Patients were randomly selected for the controlled study and put either into the tissue welding group "TW group" or the conventional treatment group "CT group".

During the period between May 2005 - January 2006, 41 consecutive patients were operated on for spontaneous pneumothorax.
From these 41 patients, 24 patients with an average age of 28.1 yrs were included in the TW group. Indications for surgery of the TW group were: recurrence of pneumothorax in 13 cases (54%), prolonged air leakage in 9 (37%), haemopneumothorax in 1, major bullous changes viewed on direct thoracoscopy in 1 case. On the day of their surgeries, 12 patients had been observed with prolonged air leakage ranging from 2 to 5 days.
Of the original 41 patients, 17 patients were included in the CT group with an average age of 26.5 yrs. Indications for surgery were: recurrence of pneumothorax in 13 (76%) cases, prolonged air leakage in 2 cases, spontaneous pneumohaemothorax in 2 cases, 5 patients from the CT group were observed with an air leakage prior to the surgery.

In the both groups surgery was made through limited lateral thoracotomy. In the TW group by applying the RF tissue welding, the bullae were reduced allowing the visceral pleura to form a natural seal of the alveoli thus eliminating air leakage without lung resection, tissue removal, or other surgery with the original bipolar welding device without the use of staples, glues, sutures or sealants. In the CT group, we performed apical wedge resection removing portions of the lung and using a conventional stapler as the lung closing device. Abrasion and coagulation of parietal pleura was done in both groups.

In all patients of the tissue welding group where air leakage was observed prior to surgery, the tissue welding technology achieved sealing the lungs without resection or use of sutures, glues, sealants or staples.

Operating time in the tissue welding as compared to the control groups was 67 and 75 minutes respectively (p>0.05), chest drains were removed on an average of 2.58 and 3.35 days postoperatively (p<0.05), postoperative hospital stay was 5.04 and 5.7 days (p>0.05). In the CT group, 2 patients also had prolonged air leakage and incomplete lung expansion after surgery while the TW group had no air leakage or incomplete lung expansion after surgery. During the follow-up period that ranged from 1 to 12 months there were no recurrences that appeared in either group.

Welding on lung tissue is easy to use and allows repair of the lung without resection and removal of lung portions thus sealing the lungs and avoiding removal of portions of this key organ without the use of foreign matters such as staples, sutures, glues or sealants, and prevents post-surgery air leakage in spontaneous pneumothorax. Lung tissue welding can also be performed using the thoracoscopic approach. At the time of this report we have performed 30 video-thoracoscopic welding procedures. It is possible for this technique to replace conventional surgical methods such as sutures and staples while providing reduced operating time, shorter patient healing time and shorter hospital stays.
In expansion of surgical uses and techniques of the thoracic applications of the tissue welding technology we are cataloguing the long-term results and morphological studies to develop a long-term expanded data base as the number of patients grows.

The tissue welding/bonding technology for repair and reconnection of tissue and hollow organs is smokeless, with little heat migration in the tissue, results in no necrosis and is without the use of foreign matter or conventional wound-closing devices, such as of staples, sutures, glues or sealants. The procedures are almost bloodless while bonding and reconnecting incised or damaged tissue aimed at restoring the normal functions of the live organs and tissue. The technology leaves little or no scar visible to the naked eye.

Surgeons at 10 Ukraine hospitals and clinics are using the tissue welding/bonding technology in clinical trials, have completed more than 6,000 human surgeries using over 70 types of open and laparoscopic surgical procedures and have demonstrated that the technology is universal in its ability to repair soft biological tissue. These surgeries included lung, neuro-surgery, nasal septum, intestine, stomach, skin, gall bladder, liver, spleen, blood vessels, nerves, alba linea, uterus, bladder, gynecology, fallopian tube, ovary and testicles and dura-matter.

Acknowledgements: CSMG Technologies, Inc. owns the technology and financed R&D managed by International Association "Welding" of the E. O. Paton Electric Welding Institute were the technology was invented.

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