Laparoscopic Electromyography and Electrostimulation of the Gastrointestinal Tract Before Placement of Theranostic Devices.

NEED: Electrical stimulation (ES) is a promising therapy for multisegmental gastrointestinal (GI) motility disorders such as gastroparesis with slow-transit constipation or chronic intestinal pseudo-obstruction. Wireless communicating GI devices for smart sensing and ES-based motility modulation will soon be available. Before placement, a potential benefit for each GI segment must be intraoperatively assessed. TECHNICAL SOLUTION: A minimally invasive multisegmental electromyography (EMG) analysis with ES of the GI tract is required. PROOF OF CONCEPT: Two porcine experiments were performed with a laparoscopic setup. Multiple hook-needle electrodes were subserosally applied in the stomach, duodenum, jejunum, ileum, and colon. EMG signals were acquired for computer-assisted motility analysis. Gastric ES, duodenal ES, jejunal ES, ileal ES, and colonic ES were applied. NEXT STEPS: Further technological and rapid regulatory solutions are desired to initialize a clinical trial of the next generation devices in the near future. CONCLUSION: We demonstrate a laparoscopic strategy with EMG analysis and ES of multiple GI segments. Thus, GI function may be evaluated before theranostic devices are placed. Extended GI resection or organ transplantation may be delayed or even avoided in affected patients.

Robotic Setup Promises Consistent Effects of Multilocular Gastrointestinal Electrical Stimulation: First Results of a Porcine Study.

BACKGROUND: Electrical stimulation (ES) of several gastrointestinal (GI) segments is a promising therapeutic option for multilocular GI dysmotility, but conventional surgical access by laparotomy involves a high degree of tissue trauma. We evaluated a minimally invasive surgical approach using a robotic surgical system to perform electromyographic (EMG) recordings and ES of several porcine GI segments, comparing these data to an open surgical approach by laparotomy. MATERIALS AND METHODS: In 5 acute porcine experiments, we placed multiple electrodes on the stomach, duodenum, jejunum, ileum, and colon. Three experiments were performed with a median laparotomy and 2 others using a robotic platform. Multichannel EMGs were recorded, and ES was sequentially delivered with 4 ES parameters to the 5 target segments. We calculated pre- and poststimulatory spikes per minute (Spm) and performed a statistical Poisson analysis. RESULTS: Electrode placement was achieved in all cases without complications. Increased technical and implantation time were required to achieve the robotic electrode placement, but invasiveness was markedly reduced in comparison to the conventional approach. The highest calculated (c)Spm values were found in the poststimulatory period of the small bowel with both the conventional and robotic approaches. Six of the 20 Poisson test results in the open setup reached statistical significance and 12 were significant in the robotic experiments. CONCLUSIONS: The robotic setup was less invasive, revealed more consistent effects of multilocular ES in several GI segments, and is a promising option for future preclinical and clinical studies of GI motility disorders.

Translational development and pre-clinical evaluation of prototype gastrointestinal mock-up devices: only robotic placement of plastic?

Background: The aim of this study was to address the vision of wireless theranostic devices distributed along the gastrointestinal (GI) tract by defining design requirements, developing prototype mock-ups, and establishing a minimally invasive surgical approach for the implantation process.Methods: Questionnaires for contextual analysis and use case scenarios addressing the technical issues of an implantable GI device, a possible scenario for implantation, preparation and calibration of a device, and therapeutic usage by professionals and patients were completed and discussed by an interdisciplinary team of surgeons, engineers, and product designers. Two acute porcine experiments were conducted with a robotic surgical system under general anaesthesia.Results: A variety of requirements for the design and implantation of implantable devices for modulating GI motility were defined. Five prototype implant mock-ups were three-dimensional (3D)-printed from black polymer material (width 22.32 mm, height 7.66 mm) and successfully implanted on the stomach, duodenum, jejunum, ileum, and colon using the robotic surgical system, without any complications.Conclusions: Our study shows the development and successful pre-clinical evaluation of a reliable device design with a minimally invasive implantation approach. Several stages of device development, including pre-clinical tests, characterisation of clinical requirements, regulatory affairs, and marketing issues should be managed side by side.

Five-fold Gastrointestinal Electrical Stimulation With Electromyography-based Activity Analysis: Towards Multilocular Theranostic Intestinal Implants.

BACKGROUND/AIMS: Motility disorders are common and may affect the entire gastrointestinal (GI) tract but current treatment is limited. Multilocular sensing of GI electrical activity and variable electrical stimulation (ES) is a promising option. The aim of our study is to investigate the effects of adjustable ES on poststimulatory spike activities in 5 GI segments. METHODS: Six acute porcine experiments were performed with direct ES by 4 ES parameter sets (30 seconds, 25 mA, 500 microseconds or 1000 microseconds, 30 Hz or 130 Hz) applied through subserosal electrodes in the stomach, duodenum, ileum, jejunum, and colon. Multi-channel electromyography of baseline and post-stimulatory GI electrical activity were recorded for 3 minutes with hook needle and hook-wire electrodes. Spike activities were algorithmically calculated, visualized in a heat map, and tested for significance by Poisson analysis. RESULTS: Post-stimulatory spike activities were markedly increased in the stomach (7 of 24 test results), duodenum (8 of 24), jejunum (23 of 24), ileum (18 of 24), and colon (5 of 24). ES parameter analysis revealed that 80.0% of the GI parts (all but duodenum) required a pulse width of 1000 microseconds, and 60.0% (all but jejunum and colon) required 130 Hz frequency for maximum spike activity. Five reaction patterns were distinguished, with 30.0% earlier responses (type I), 42.5% later or mixed type responses (type II, III, and X), and 27.5% non-significant responses (type 0). CONCLUSIONS: Multilocular ES with variable ES parameters is feasible and may significantly modulate GI electrical activity. Automated electromyography analysis revealed complex reaction patterns in the 5 examined GI segments.

Research platform for medical device development to simplify translation to the market.

New regulations for medical products complicate research projects for new application fields and translation of innovative product ideas to refundable medical products becomes a high economic risk. All this demands for a CE-marked platform, which offers the possibility to access the recorded data online or even directly the hardware during research applications, to bridge the gap. This paper describes how a CE-marked medical product can be extended by different interfaces to enable basic research or simplify first proof-of-concept studies thus optimizing prototype development in research projects, simplifying the documentation process and reducing the risk for market access.

Application of a newly designed microfork probe for robotic-guided pelvic intraoperative neuromapping.

Introduction: Robotic-assisted total mesorectal excision (TME) with pelvic intraoperative neuromapping was recently accomplished. However, neuromapping is conventionally conducted by a hand-guided laparoscopic probe. We introduce a prototype microfork probe to make robotic-guided neuromapping feasible. Experiments and Technical Setup: Two porcine experiments with nerve-sparing TME surgery were performed. A newly designed prototype bipolar microfork probe was inserted intraabdominally and guided with the robotic forceps. Intermittent neuromapping was then conducted and neuromonitoring data integrated in the surgeon console viewer. Conclusion: Robotic-guided neuromapping is shown to be feasible and fully controllable from the surgeon console.

Robot-guided neuromapping during nerve-sparing taTME for low rectal cancer.

PURPOSE: Intraoperative pelvic neuromapping with electrophysiological evaluation of autonomic nerve preservation during robotic total mesorectal excision (TME) for rectal cancer is conventionally performed by the bedside assistant with a hand-guided probe. Our goal was to return autonomy over the neuromonitoring process to the colorectal surgeon operating the robotic console. METHODS: A recently described prototype microfork electrostimulation probe was evaluated intraoperatively during abdominal robotic-assisted transanal TME (taTME) surgery for low rectal cancer in three consecutive male patients. RESULTS: An intraoperative video demonstrates the good control and maneuverability of the prototype probe with electrophysiological confirmation of bilateral pelvic autonomic nerve preservation. CONCLUSIONS: This study presents the first in situ application of a new microfork probe for fully robot-guided neuromapping in three patients undergoing TME surgery for low rectal cancer.

Novel multi-image view for neuromapping meets the needs of the robotic surgeon.

BACKGROUND: Pelvic intraoperative neuromonitoring during nerve-sparing robot-assisted total mesorectal excision (RTME) is feasible. However, visual separation of the neuromonitoring process from the surgeon console interrupts the workflow and limits the usefulness of available information as the procedure progresses. Since the robotic surgical system provides multi-image views in the surgeon console, the aim of this study was to integrate cystomanometry and internal anal sphincter electromyography signals to aid the robotic surgeon in his/her nerve-sparing technique. METHODS: We prospectively investigated 5 consecutive patients (1 male, 4 females) who underwent RTME for rectal cancer at our institution in 2017. The robotic surgery was performed using the da Vinci Xi combined with pelvic intraoperative neuromapping with real-time electromyography and cystomanometry signal transmission by multi-image view during RTME. RESULTS: The adapted two-dimensional pelvic intraoperative neuromonitoring imaging successfully simulcasted to the surgeon console view in all 5 cases. The technical note is complemented by an intraoperative video. CONCLUSIONS: This report demonstrates the technical feasibility of an improved neuromonitoring process during nerve-sparing RTME. Robotic neuromapping can be fully visualized from the surgeon console.