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BACKGROUND: Gastric electrical stimulation (GES) has been studied for decades as a promising treatment for obesity. Stimulation pulses with fixed amplitude and pulse width are usually applied, but these have limitations with regard to overcoming habituation to GES and inter-subject variation. This study aims to analyze the efficacy of an adaptive GES protocol for reducing food intake and maintaining lean weight in dogs. METHODS: Six beagle dogs were implanted with a remotely programmable gastric stimulator. An adaptive protocol was designed to increase the stimulation energy proportionally to the excess of food consumption, with respect to the dogs' maintenance energy requirements. After surgery and habituation to experimental conditions, the dogs went through both a control and a stimulation period of 4 weeks each, in a randomized order. The stimulation parameters were adapted daily. Body weight, food intake, food intake rate, and postprandial cutaneous electrogastrograms (EGG) were recorded to assess the effect of adaptive GES. RESULTS: Adaptive GES decreased food intake and food intake rate (p < 0.05) resulting in weight maintenance. In the absence of GES, the dogs gained weight (p < 0.05). Postprandial EGG dominant frequency was accelerated by GES (p < 0.05). The strategy of adapting the stimulation energy was effective in causing significant mid-term changes. CONCLUSION: Adaptive GES is effective for reducing food intake and maintaining lean weight. The proposed adaptive strategy may offer benefits to counter habituation and adapt to inter-subject variation in clinical use of GES for obesity.
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Ingestão de Alimentos , Terapia por Estimulação Elétrica , Animais , Cães , Ingestão de Alimentos/fisiologia , Estimulação Elétrica , Terapia por Estimulação Elétrica/métodos , Obesidade/terapia , EstômagoRESUMO
Gastrointestinal stimulator implants have recently shown promising results in helping obese patients lose weight. However, to place the implant, the patient currently needs to undergo an invasive surgical procedure. We report a less invasive procedure to stimulate the stomach with a gastrostimulator. After attempting fully endoscopic implantation, we more recently focused on a single incision percutaneous procedure. In both cases, the challenges in electronic design of the implant are largely similar. This article covers the work achieved to meet these and details the in vivo validation of a gastrostimulator aimed to be endoscopically placed and anchored to the stomach.
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Regulação do Apetite , Ingestão de Alimentos , Terapia por Estimulação Elétrica/instrumentação , Comportamento Alimentar , Neuroestimuladores Implantáveis , Implantação de Prótese/instrumentação , Estômago/inervação , Animais , Cães , Terapia por Estimulação Elétrica/métodos , Eletromiografia , Desenho de Equipamento , Gastroscopia , Masculino , Teste de Materiais , Modelos Animais , Implantação de Prótese/métodos , Fatores de TempoRESUMO
Inductive links represent a highly promising avenue for both powering and communicating medical implants. Yet they encounter challenges such as constrained communication distance and limited data rate. In Load Shift Keying (LSK), a switch in the secondary side of the inductive link can be placed in parallel with the load (Short-Circuit Technique - SCT), in series with the load (Open-Circuit Technique - OCT), or both (Dual Technique - DLT), to vary the impedance of the secondary. Hence, the impedance reflected to the primary side changes and is used to transmit information externally from the implant. Among these, DLT is a novel LSK technique proposed in this work, which becomes independent from the load on the implant side. This study compares these three methods, confronting measurements to simulations. The evaluation focused on variations in coil distance and load. The proposal is illustrated in the case of an implantable gastric stimulator, with specific constraints in secondary coil size and power requirements. The newly developed DLT consistently outshone SCT and OCT in extending the operational range of communication, registering a maximum modulation index of 0.797 and a bit error rate below 10- 7 at an operating distance of 95 mm through the air. Its load-independent characteristic allowed DLT to surpass the performance of SCT and OCT, which were each advantageous under high and low loads, respectively. All these results are confirmed by a LTSpice simulation. Consequently, the communication techniques put forward in this work mark a significant progression in medical implant communications, enhancing coil-to-coil operational distance while adhering to a low carrier frequency.
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Objective.Finite element modelling has been widely used to understand the effect of stimulation on the nerve fibres. Yet the literature on analysis of spontaneous nerve activity is much scarcer. In this study, we introduce a method based on a finite element model, to analyse spontaneous nerve activity with a typical bipolar electrode recording setup, enabling the identification of spontaneously active fibres. We applied our method to the vagus nerve, which plays a key role in refractory epilepsy.Approach.We developed a 3D model including dynamic action potential (AP) propagation, based on the vagus nerve geometry. The impact of key recording parameters-inter-electrode distance and temperature-and uncontrolled parameters-fibre size and position in the nerve-on the ability to discriminate active fibres were quantified. A specific algorithm was implemented to detect and classify APs from recordings, and tested on six ratin-vivovagus nerve recordings.Main results.Fibre diameters can be discriminated if they are below 3µm and 7µm, respectively for inter-electrode distances of 2 mm and 4 mm. The impact of the position of the fibre inside the nerve on fibre diameter discrimination is limited. The range of active fibres identified by modelling in the vagus nerve of rats is in agreement with ranges found at histology.Significance.The nerve fibre diameter, directly proportional to the AP propagation velocity, is related to a specific physiological function. Estimating the source fibre diameter is thus essential to interpret neural recordings. Among many possible applications, the present method was developed in the context of a project to improve vagus nerve stimulation therapy for epilepsy.
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Estimulação do Nervo Vago , Nervo Vago , Potenciais de Ação/fisiologia , Animais , Análise de Elementos Finitos , Fibras Nervosas/fisiologia , Ratos , Nervo Vago/fisiologiaRESUMO
A novel electrode anchoring design and its implantation procedure, aiming for a minimally invasive solution for gastric electrical stimulation, are presented. The system comprises an anchor made of a flexible body embedding two needle-shaped electrodes. The electrodes can easily switch from a parallel position - to pierce the stomach - to a diverging position - enabling them to remain firmly anchored into the muscular layer of the stomach. Key device parameters governing anchoring stability were assessed on a traction test bench, and optimal values were derived. The device was then implanted in six dogs by open surgery to assess its anchoring durability in vivo. Computed tomography images showed that the electrodes remained well placed within the dogs' gastric wall over the entire assessment period (more than one year). Finally, a prototype of a surgical tool for the minimally invasive device placement was manufactured, and the anchoring procedure was tested on a dog cadaver, providing the proof of concept of the minimally invasive implantation procedure. The use of our electrode anchoring system in long-term gastric electrical stimulation is promising in terms of implantation stability (the anchor withstands a force up to 0.81 N), durability (the anchor remains onto the stomach over one year) and minimal invasiveness of the procedure (the diameter of the percutaneous access is smaller than 12 mm). Moreover, the proposed design could have clinical applications in other hollow organs, such as the urinary bladder.
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Procedimentos Cirúrgicos Minimamente Invasivos , Estômago , Animais , Cadáver , Cães , Eletrodos Implantados , Estômago/diagnóstico por imagem , Estômago/cirurgiaRESUMO
Inductive powering of implantable medical devices involves numerous factors acting on the system efficiency and safety in adversarial ways. This paper lightens up their role and identifies a procedure enabling the system design. The latter enables the problem to be decoupled into four principal steps: the frequency choice, the magnetic link optimization, the secondary circuit and then finally the primary circuit designs. The methodology has been tested for the powering system of a device requirering a power of 300mW and implanted at a distance of 15 to 30mm from the outside power source. It allowed the identification of the most critical parameters. A satisfying efficiency of 34% was reached at 21mm and tend to validate the proposed design procedure.
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In this document we discuss the main challenges encountered when producing flexible electrical stimulation implants, and present our approach to solving them for prototype production. We include a study of the optimization of the flexible PCB design, the selection of additive manufacturing materials for the mold, and the chemical compatibility of the different materials. Our approach was tested on a flexible gastro-stimulator as part of the ENDOGES research program.
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Power efficiency is critical for electrical stimulators. Battery life of wearable stimulators and wireless power transmission in implanted systems are common limiting factors. Boost DC/DC converters are typically needed to increase the supply voltage of the output stage. Traditionally, boost DC/DC converters are used with fast control to regulate the supply voltage of the output. However, since stimulators are acting as current sources, such voltage regulation is not needed. Banking on this, this paper presents a DC/DC conversion strategy aiming to increase power efficiency. It compares, in terms of efficiency, the traditional use of boost converters to two alternatives that could be implemented in future hardware designs.
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Gastrointestinal stimulator implants have recently shown positive results in helping obese patients lose weight. However, to place the implant, the patient currently needs to undergo an invasive surgical procedure. Our team is aiming for a less invasive procedure to stimulate the stomach with a gastrostimulator. Attempts covered fully endoscopic implantation and, more recently, we have focussed on a single incision laparoscopic procedure. Whatever the chosen implantation solution, the electronic design of the implant system shares many challenges. This paper covers the work achieved to meet these.