COOLINGIS is a surgical dissecting sealer for soft tissue. It allows for a hemostatic seal, cut coagulation (in models with included blade), which makes it ideal for total or partial resection of organs such as the liver, kidneys, pancreas and spleen.
Its optimal design, with an internally refrigerated electrode and an optional blade, allows for a successful precoagulated tissue cut as well as for an instant coagulation after conventional tissue section.
Long and short models allow for use in laparoscopy and laparotomy, respectively.
MODELS AND REFERENCE NUMBERS
|Laparotomy cut and coagulation (DUAL)||Short 3mm diameter electrode with blade||BIS-3C11|
|Short 5mm diameter electrode with blade||BIS-5C11|
|Short 8mm diameter electrode with blade||BIS-8C11|
|Laparotomy Coagulation (COAG)||Short 3mm diameter electrode without blade||BIS-3C01|
|Short 5mm diameter electrode without blade||BIS-5C01|
|Short 8mm diameter electrode without blade||BIS-8C01|
|Laparoscopy cut and coagulation (DUAL)||Long 3mm diameter electrode with blade||BIS-3L11|
|Long 5mm diameter electrode with blade||BIS-5L11|
|Laparotomy Coagulation (COAG)||Long 3mm diameter electrode without blade||BIS-3L01|
|Long 5mm diameter electrode without blade||BIS-5L01|
DUAL working mode
DUAL working mode allows for cauterization and cutting of the tissue with built-in blade. This allows for the reduction of the number of instruments used during surgery as there is no need to use another instrument to cut.
The tissue coagulates by sustaining the electrode surface and, later, the previously coagulated tissue is cut with the blade.
Internal refrigeration system
The refrigerated saline circulates within the electrode without ever touching the patient’s tissue, which allows:
- Avoiding carbonized tissue getting stuck to the electrode thus creating a minor smoke incidence.
- Increasing product security. Some similar device-produced incidents are due to burns in surgical area created by heated irrigated saline.
- Creating an isolated injury below the surface of the electrode.
Internal refrigeration allows for an increased injury depth (up to 6mm) and sealing of vessels up to 7mm (following models and power levels), without increasing thermal injury risk in close-by structures. This allows for an additional functional ablation margin, which may avoid local liver recurrence when compared to conventional technology, especially when the healthy tissue resection margin the surgeon may have left is very scarce1.
Design and ease of use
The design of the electrode allows for the creation of extensive injuries when completely sustained on the tissue, thus quickly creating coagulation lines. The electrode tip allows for easy blood vessel sealing. However, the device easily adapts to operating scenarios in which the surgeon prefers to combine it with other surgical instruments (thermosealers or dissection instruments) with the goal of creating more selective coagulations.
The electrode’s curved body eases movement through the workspace — it allows an easy access to areas in need of coagulation and points of potential hemorrhage.
COOLINGBIS allows for a coagulation combination through radio-frequency using other devices to perform the cut (e.g. ultrasonic).
There is no doubt that, in the present time, COOLINGBIS is one of the highest coagulation efficiency devices in the market. Its great coagulation power drastically reduces blood loss, therefore, it should reduce the need for transfusion. Its great coagulation capabilities are especially useful in laparoscopic approaches, in which resources for a quicker and more efficient hemostasis are more limited.
COOLINGBIS is recommended for, but not limited to, its use in:
In patients in need of hemostatic sealing, coagulation and/or soft tissue cutting. As it allows for coagulation and tissue cut, it is especially made for a total or partial resection of the organs above, that is to say, radio-assisted surgical resections.
CLINICAL RESULTS IN LIVER
1. Complication reduction
It reduces the need for camplage operations3
It reduces surgery time3
The coagulative necrosis plane allows for an optimal vessel and duct sealing thus reducing biliary fistula risk4,5
2. Lower need of transfusion
COOLINGBIS’s great coagulation power drastically reduces blood loss.
Randomized clinical trial results to evaluate the impact COOLINGBIS had in intraoperatory blood loss during liver resection (AGEMED 312/08 EC)6.
The box plot shows blood loss during transection (A) and blood loss as per transection area (B) in the Control Group, in which hemostasis is obtained through conventional approaches, and the MRFC group (mono-polar radio-frequency coagulation), in which hemostasis is obtained through COOLINGBIS.
The box represents the interquartile range which contains 50% of the total values. The whiskers are lines that extend from the box to the higher and lower values. The box line indicates the average. Both results are statistically meaningful (*p<.05).
3. Shorter post-surgery time
Hospital time becomes significantly shorter3
POST-SURGERY HOSPITAL TIME (days)
Results from successive patients in the COOLINGBIS series in the study ref. 312/08/EC3. Patient number 3 — after hepatic transection and in the same surgical act — was performed an anterior rectal resection with hysterectomy and partial cystectomy through invasive colon neoplasia of said organs. He was intervened 11 days after as a consequence of a colorectal anastomosis leakage from which he favorably evolved.
4. Complete plane transection regeneration after surgery
5. Reduction of local relapse
It allows to create a deep thermal injury which may reduce local hepatic relapse.
LOCAL HEPATIC RELAPSE
Local hepatic relapse in all patients (A) and local hepatic relapse in cases with positive margins. In the Control Group, with patients operated using conventional approaches and in the RFAT group (RF-assisted transection device), with patients operated using COOLINGBIS, after a 28.5 month tracing. In patients with positive margins, 0% of patients operated with COOLINGBIS showed local hepatic relapse, compared to a 27% of the patients operated with conventional approaches1.
(A) Liver after withdrawing the sample; the coagulated tissue (double arrow) and the resection margin (*) can be appreciated.
(B) The same patient’s liver sample; the resection margin and thickness of the coagulated tissue (double arrow) can be observed, which are in contact with the metastasis (arrow). The * shows the correct position of the sample.
(C) Histological section of the resection of the margins of the sample (use asterisk for correct position). The resection margin is marked in green ink. The tumor (T) and the coagulated parenchyma (P) are shown in contact with the margin. The non coagulated tumor did not stop a correct evaluation of the margin invasion from being carried.
(D) TC of the same patient 56 months after liver resection, no signs of local hepatic relapse to be observed. The leftover ablated tissue can be observed in the margin (red arrow)1.
- Quesada, R. et al. The impact of radiofrequency-assisted transection on local hepatic recurrence after resection of colorectal liver metastases. Surg. Oncol. 26, 229–235 (2017).
- Quesada, R. et al. Laparoscopic partial splenectomy for giant cyst using a radiofrequency-assisted device: a case report. Surg. Case Reports 2, 2–5 (2016).
- Burdio, F. et al. A new single-instrument technique for parenchyma division and hemostasis in liver resection: A clinical feasibility study. Am. J. Surg. 200, e75–e80 (2010).
- Stavrou, G. A., Donati, M., Fruehauf, N. R., Flemming, P. & Oldhafer, K. J. Liver resection using heat coagulative necrosis: Indications and limits of a new method. ANZ J. Surg. 79, 624–628 (2009).
- Weber, J. C. et al. New technique for liver resection using heat coagulative necrosis. Ann. Surg. 236, 560–563 (2002).
- Quesada, R. et al. Impact of monopolar radiofrequency coagulation on intraoperative blood loss during liver resection: a prospective randomised controlled trial. Int. J. Hyperth. 33, 135–141 (2017).