A new bipolar device for sealing and cutting: ex and in vivo studies for performance evaluation

Abstract

Introduction

A novel multipurpose bipolar radiofrequency instrument, the Erbe Dissector (EDS), which simultaneously seals and cuts tissue, was developed. Ex vivo sealing rate and time, burst pressure, jaw temperature and thermal spread were studied in porcine renal arteries.

Material and methods

In vivo, 13 surgical tasks were performed in two pigs: beside sealing rate and time, overall performance in sharp and blunt dissection, tissue sticking, hemostasis, precision, etc., were evaluated by four surgeons compared with ENSEAL G2 (EG2) using surveys on a Likert scale (1 = very poor; 5 = very good).

Results

Ex vivo, the EDS sealing rate was 91.7% (33/36 arteries) at an average sealing time of 2.1 s (range 1.7–2.8) and a burst pressure of 1040 ± 350 mmHg. The maximum jaw temperature was 87 ± 4 °C and the mean lateral thermal spread was 0.8 ± 0.2 mm. In vivo, the sealing rate for arteries and veins was 92.6% (50/54) and the median seal and cut time was 1.6 s (range: 1.3–2.9). The average EDS performance score across all tasks was 4.4 ± 0.6 Likert points. For five shared tasks, EDS was better than EG2 (4.4 ± 0.5 versus 3.4 ± 0.6 Likert points; p = 0.016).

Conclusions

EDS seals and cuts arteries and veins rapidly with good safety and user-friendliness.

Keywords:

• Vessel sealing
• electric cutting
• animal model
• seal and cut time
• sealing rate

Acknowledgments

The authors thank M. Seitzer, A. Stolz, C. Fahrner and T.O. Greiner for their excellent veterinarian and technical assistance and Mary Heaney Margreiter for her kind contribution to preparation of the manuscript.

Author contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Karolin Thiel, Markus D. Enderle, Walter Linzenbold, Luca T. Frericks and Ulrich Biber. The operators were Karolin Thiel, Sara Y. Brucker, Bernhard Kraemer and Volker Steger. The first draft of the manuscript was written by Christian Thiel and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Institutional review board statement

The animal study was approved by the Institutional Review Board for animal experiments of the Tuebingen Regional Council, Germany (approval code C01‑17 G in 2017).

Informed consent statement

Not applicable.

Disclosure statement

Luca T. Frericks, Ulrich Biber, Walter Linzenbold und Markus D. Enderle are employees of Erbe Elektromedizin GmbH. Christian Thiel, Martin Schenk, Alfred Königsrainer, Sara Y. Brucker, Bernhard Kraemer, Volker Steger and Karolin Thiel have no conflicts of interests or financial ties to disclose.

Supplementary material

The following supporting information can be downloaded at: www.mdpi.com/xxx/s1, Table S1: Number of Likert items and operators for each performance aspect for the Erbe Dissector (EDS) and ENSEAL G2 (EG2)

Data availability statement

The data presented in this study are available on reasonable request from the corresponding author.

Additional information

Funding

This research was funded by Erbe Elektromedizin GmbH, Tuebingen, Germany.