0000000000054423
AUTHOR
Klaus-peter Hoffmann
Modeling the pelvic region for non-invasive pelvic intraoperative neuromonitoring
Abstract Finite element analysis (FEA) of electric current distribution in the pelvis minor may help to assess the usability of non-invasive surface stimulation for continuous pelvic intraoperative neuromonitoring. FEA requires generation of quality volumetric tetrahedral mesh geometry. This study proposes the generation of a suitable mesh based on MRI data. The resulting volumetric mesh models the autonomous nerve structures at risk during total mesorectal excision. The model also contains the bone, cartilage, fat, skin, muscle tissues of the pelvic region, and a set of electrodes for surface stimulation. The model is ready for finite element analysis of the discrete Maxwell’s equations.
Design and fabrication of an ultra-flexible electrode system for invasive continuous monitoring during surgery
This paper introduces the development, design and characterization of a tube with electrodes for stimulation and recording. This tube can be used as an operative monitoring system for thyroid surgery. In such surgeries damaging of the neural tissue can result in permanently malfunction. Continuous nerve monitoring can reduce significantly this risk.
Selective pelvic autonomic nerve stimulation with simultaneous intraoperative monitoring of internal anal sphincter and bladder innervation.
<i>Background:</i> Pelvic autonomic nerve preservation avoids postoperative functional disturbances. The aim of this feasibility study was to develop a neuromonitoring system with simultaneous intraoperative verification of internal anal sphincter (IAS) activity and intravesical pressure. <i>Methods:</i> 14 pigs underwent low anterior rectal resection. During intermittent bipolar electric stimulation of the inferior hypogastric plexus (IHP) and the pelvic splanchnic nerves (PSN), electromyographic signals of the IAS and manometry of the urinary bladder were observed simultaneously. <i>Results:</i> Stimulation of IHP and PSN as well as simultaneous intraop…
Electrical stimulation with motility analysis of five parts of the gastrointestinal tract ; First evaluation of an experimental protocol in a porcine model
Abstract Gastrointestinal (GI) motility disorders are frequent and clinically significant conditions with impairment of patient’s quality of life. Examples range from upper GI symptoms such as dysphagia and gastroparesis to lower GI manifestations, namely chronic-intestinal pseudo obstruction, diarrhea and constipation. Furthermore, postoperative motility disorders are common. Currently, available pharmacological or dietetic treatment options are limited. Since GI motility is based on myoelectric activity, electrical stimulation (ES) is a promising alternative. Numerous studies have demonstrated suitable pacing strategies and parameters in different GI segments. However, results of multiloc…
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.
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 electri…
Transcutaneous sacral nerve stimulation for intraoperative verification of internal anal sphincter innervation.
Background: The current standard for pelvic intraoperative neuromonitoring (pIONM) is based on intermittent direct nerve stimulation. This study investigated the potential use of transcutaneous sacral nerve stimulation for non‐invasive verification of pelvic autonomic nerves. Methods: A consecutive series of six pigs underwent low anterior rectal resection. For transcutaneous sacral nerve stimulation, an array of ten electrodes (cathodes) was placed over the sacral foramina (S2 to S4). Anodes were applied on the back, right and left thigh, lower abdomen, and intra‐anally. Stimulation using the novel method and current standard were performed at different phases of the experiment…
Is intraoperative neuromonitoring associated with better functional outcome in patients undergoing open TME?
Aims: Intraoperative neuromonitoring (IONM) aims to control nerve-sparing total mesorectal excision (TME) for rectal cancer in order to improve patients’ functional outcome. This study was designed to compare the urogenital and anorectal functional outcome of TME with and without IONM of innervation to the bladder and the internal anal sphincter. Methods: A consecutive series of 150 patients with primary rectal cancer were analysed. Fifteen match pairs with open TME and combined urogenital and anorectal functional assessment at follow up were established identical regarding gender, tumour site, tumour stage, neoadjuvant radiotherapy and type of surgery. Urogenital and anorectal function was…
Extracorporeal Stimulation of Sacral Nerve Roots for Observation of Pelvic Autonomic Nerve Integrity: Description of a Novel Methodological Setup.
Introduction: Neurophysiologic monitoring can improve autonomic nerve sparing during critical phases of rectal cancer surgery. Objectives: To develop a system for extracorporeal stimulation of sacral nerve roots. Methods: Dedicated software controlled a ten-electrode stimulation array by switching between different electrode configurations and current levels. A built-in impedance and current level measurement assessed the effectiveness of current injection. Intra-anal surface electromyography (sEMG) informed on targeting the sacral nerve roots. All tests were performed on five pig specimens. Results: During switching between electrode configurations, the system delivered 100% of the set cur…
Online signal processing of internal anal sphincter activity during pelvic autonomic nerve stimulation: a new method to improve the reliability of intra-operative neuromonitoring signals
Aim Intra-operative neuromonitoring is increasingly applied in several surgical disciplines and has been introduced to facilitate pelvic autonomic nerve preservation. Nevertheless, it has been considered a questionable tool for the minimization of risk, as the results are variable and might be misleading. The aim of the present experimental study was to develop an intra-operative neuromonitoring system with improved reliability for monitoring pelvic autonomic nerve function. Method Fifteen pigs underwent low anterior rectal resection with pelvic autonomic nerve preservation. Intra-operative neuromonitoring was performed under autonomic nerve stimulation with observation of electromyograph…
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 cond…
Robotic Setup Promises Consistent Effects of Multilocular Gastrointestinal Electrical Stimulation: First Results of a Porcine Study
<b><i>Background:</i></b> 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. <b><i>Materials and Methods:</i></b> In 5 acute porcine experiments, we placed multiple electrodes on the stomach, duodenum, jejunum, ileum, and colon. Three experime…
Motility analysis by means of video tracked markers
Abstract The motility of the gastrointestinal tract is crucial for digestive activity and dysfunction can lead to severe disease pattern. A method for analysing the motility is needed when treatment approaches shall be evaluated. Therefore markers attached to different locations on the stomach and the bowel of pigs are video tracked in this research study. The markers are designed to provide a high contrast and have an adhesive side for fixation. Above the operation field a video camera has been placed to film the markers during the procedure. To analyse the video data a special algorithm has been implemented. The algorithm requires a registration process at the beginning of each recording …
Surface Electromyography Reliably Records Electrophysiologically Evoked Internal Anal Sphincter Activity: A More Minimally Invasive Approach for Monitoring Extrinsic Innervation.
<b><i>Background:</i></b> Even in the case of minimally invasive pelvic surgery, sparing of the autonomic nerve supply is a prerequisite for maintaining anal sphincter function. Internal anal sphincter (IAS) innervation could be electrophysiologically identified based on processed electromyographic (EMG) recordings with conventional bipolar needle electrodes (NE). This experimental study aimed for the development of a minimally invasive approach via intra-anal surface EMG for recordings of evoked IAS activity. <b><i>Methods:</i></b> Six male pigs underwent nerve-sparing low anterior rectal resection. Electric autonomic nerve stimulations were …
Postprocessing algorithm for automated analysis of pelvic intraoperative neuromonitoring signals
Abstract Two dimensional pelvic intraoperative neuromonitoring (pIONM®) is based on electric stimulation of autonomic nerves under observation of electromyography of internal anal sphincter (IAS) and manometry of urinary bladder. The method provides nerve identification and verification of its’ functional integrity. Currently pIONM® is gaining increased attention in times where preservation of function is becoming more and more important. Ongoing technical and methodological developments in experimental and clinical settings require further analysis of the obtained signals. This work describes a postprocessing algorithm for pIONM® signals, developed for automated analysis of huge amount of …
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 cond…