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Side-to-side duodeno-ileal magnetic compression anastomosis: design and feasibility of a novel device in a porcine model

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Abstract

Background

Minimally invasive metabolic/bariatric surgery (MBS) may be further advanced by magnetic compression anastomosis (MCA) technology. The study aimed to develop a magnet sized to create a patent duodeno-ileostomy (DI) and verify its effectiveness in a porcine model.

Methods

Developmental study phase: magnets with 4 different flange-offset dimensions were tested to identify a design that would successfully form a compression anastomosis. Verification phase: evaluation of the selected design’s efficacy. In each 6-week phase (4 pigs/phase), one magnet was inserted laparoscopically in the jejunum, one placed gastroscopically in the duodenum. Magnets were aligned, gradually fused, formed an anastomosis, and then detached and were expelled. At necropsy, MCA sites and sutured enterotomy sites were collected and compared.

Results

Developmental phase: the linear BC42 magnet with a 2.3-mm flange offset design was selected. Verification phase: in 4 swine magnets were mated at the target location, confirmed radiographically. Mean time to magnet detachment 16.0 days (12–22), to expulsion 24.5 days (17–33). MCA was achieved in all animals at time of sacrifice. Animals gained a mean 9.5 kg (3.9–11.8). Specimens revealed patent anastomoses of ≥ 20 mm with smooth mucosa and minimal inflammation and fibrosis compared to sutured enterotomies. One pig underwent corrective surgery for a mesenteric hernia without sequelae.

Conclusion

In a large-animal model, gross and histopathologic examination confirmed that the linear MCA device created a patent, well-vascularized, duodeno-ileal anastomosis. The novel MCA device may be appropriate for use in human MBS procedures.

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Acknowledgements

The authors thank the Charles River Laboratories staff for their excellent conduct of the veterinary study, in particular, Aurelia Spataru-Burgoci, Rosa Kaviani, and Joanna M. Rybicka.

Funding

This study was supported by a research grant from GT Metabolic Solutions (San Jose, CA). Michel Gagner is a consultant with stock options in GT Metabolic Solutions. Michel Gagner is also a consultant for Medtronic, Inc. and Lexington Medical, Inc. and has stock options in Lexington Medical, Inc. Todd Krinke is an employee with stock options in GT. Maxime LaPointe-Gagner is employed by Westmount Surgical Center and has no conflicts of interest or financial ties to pharmaceutical or device companies to disclose. Jane Buchwald is a GT consultant with GT stock options; she received grants from Ethicon, Inc., M.I.D., Society of Bariatric and Metabolic Surgeons of Kazakhstan, Medical Faculty of Mannheim, Holy Family Hospital, Israel, and the American College of Surgeons.

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Authors and Affiliations

  1. Department of Surgery, Westmount Square Surgical Center, 1 Westmount Square, Suite 801, Westmount, QC, H3Z2P9, Canada

    Michel Gagner & Maxime Lapointe-Gagner

  2. GT Metabolic Solutions, San Jose, CA, USA

    Todd Krinke

  3. Division of Scientific Research Writing, Medwrite, Maiden Rock, WI, USA

    J. N. Buchwald

Authors
  1. Michel Gagner
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  4. J. N. Buchwald
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Correspondence to Michel Gagner.

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Ethical approval

All procedures of the study were conducted in compliance with the protocol and the standard operating procedures and institutional review board of the testing facility, Charles River Laboratories (Boisbriand, Quebec, Canada).

Human and animal rights

The study was performed in accord with the ethical standards of the animal testing facility’s Institutional Animal Care and Use Committee (IACUC) to ensure compliance with the Canadian Council on Animal Care regulations and National Academies of Science Guide for Care and Use of Laboratory Animals. No written consent was needed for an animal study.

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Gagner, M., Krinke, T., Lapointe-Gagner, M. et al. Side-to-side duodeno-ileal magnetic compression anastomosis: design and feasibility of a novel device in a porcine model. Surg Endosc 37, 6197–6207 (2023). https://doi.org/10.1007/s00464-023-10105-x

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