Method and system for assessing intra-abdominal health

Abstract

The present disclosure relates to a method of detecting a function or a change in function, in particular gastrointestinal motility, of the stomach, small intestine or peritoneum of a patient, comprising the steps of applying electrodes to opposite sides of the abdomen of the patient, the electrodes comprise at least one electrode for supplying current to the abdomen and at least one electrode for receiving current along a current path through the abdomen; providing an alternating current signal to the electrode; and determining or measuring the conductivity of the abdomen along the current path between the electrodes, wherein a change in the measured or determined conductivity of the abdomen over a period of time provides an indication of a function or dysfunction of the stomach, small intestine or peritoneum. The present disclosure also provides related systems for assessing the function or change in function of the stomach, small intestine, or peritoneum of a patient, particularly gastrointestinal motility.

Description

Technical Field

[0001] The present disclosure relates to methods and systems for assessing abdominal health, in particular methods and systems for evaluating the function of the stomach, small intestine, and peritoneum. The present disclosure particularly relates to methods and systems for assessing gastrointestinal motility and function of the gastrointestinal tract within this region of a patient. Accordingly, it will be convenient to describe the present disclosure in the context of methods and systems for assessing gastrointestinal motility and peritoneal function.

[0002] The methods and systems of the present disclosure are particularly applicable to patients who may have gastrointestinal dysfunction or peritoneal dysfunction. Such conditions may be very common in patients such as those receiving drugs or treatments that affect gastrointestinal function (such as GLP-1 receptor agonists (e.g., semaglutide) or analgesics (e.g., opioids)), or in patients with serum electrolyte imbalances, in patients recovering from surgical or non-surgical interventions, in patients with disease states (such as diabetes, ascites), and / or in patients undergoing continuous ambulatory peritoneal dialysis. However, it should be understood that the methods and systems of the present disclosure are not limited to these applications and can also be more generally used to evaluate the function within this region. Background Art

[0003] Any reference to background art herein, including any citation of any document, is only intended to facilitate the understanding of the present disclosure and should not be considered an admission that such background art is widely known in Australia or any other country or forms part of the common general knowledge in the relevant field.

[0004] The human abdomen is the part of the body between the thorax and the pelvis. The abdomen contains a series of structures, but very importantly contains organs and the gastrointestinal tract that function together as the gastrointestinal system. As a side effect of drugs, and / or as a concomitant result of surgical and non-surgical interventions, dysfunction within the human abdomen (especially the gastrointestinal system) may be present transiently or persistently in various pathological states (e.g., diabetes). A significant form of gastrointestinal dysfunction is intestinal obstruction, which is a reduction or incoordination of gastrointestinal motility. The gastrointestinal tract essentially comprises a long tube with an entrance at the stomach and an exit at the anus. Food moves through the gastrointestinal tract under the action of peristalsis, which is a series of wave-like muscle contractions in the gastrointestinal wall. If there is a lack of movement through any part of the tract, all parts upstream or "above" that part will also cease to exhibit peristalsis. Parts downstream or "below" the site of lack of movement may continue to show peristalsis. The lack of movement may be the result of drugs that alter gastrointestinal function, disease states (such as diabetes), serum electrolyte imbalances, obstruction (tumors, adhesions, intussusception), insufficient blood supply (thromboembolic infarction), inflammation (diverticulitis), infection (appendicitis), or as a result of surgery, after which the intestine may be "stunned" for a period of time.

[0005] Current techniques for evaluating the function and dysfunction of a patient's stomach, small intestine, and peritoneum can be classified into methods of patient history, physical examination, observation of vital signs, laboratory tests, and a range of research methods from imaging modalities to invasive exploration surgery. History taking typically will identify symptoms that the patient may have experienced, such as abdominal pain, nausea, vomiting, or changes in bowel habits.

[0006] Physical examination typically elicits clinical signs such as abdominal distension, shifting dullness, and auscultation of bowel sounds. Bowel sounds are associated with peristalsis, but even in healthy patients, their frequency and pitch can vary significantly. In postoperative patients, bowel sounds are intermittent at best. The accepted method is for the clinician to use a stethoscope to listen to the four quadrants of the abdomen for ten minutes once per hour. However, this is often impractical due to other duties required of the clinician and the associated variability in the presence and location of bowel sounds. Auscultation is typically performed at suboptimal listening times, which can result in extended fasting times for the patient or (occasionally) ingestion of food before peristalsis is confirmed.

[0007] The utility of research methods varies according to the clinical situation. Imaging modalities are useful when there is a suspected lesion from the patient history and / or physical examination, especially in emergency situations. However, bedside imaging modalities have not been found suitable for regular, daily use in the evaluation of gastrointestinal dysfunction or functional changes. One such modality that has been tested in this regard is portable ultrasound. However, this has generally been found to have limited value, especially considering the confounding effects that bowel gas and obesity can have on image acquisition and quality.

[0008] Autonomous methods for detecting bowel sounds have not proven successful because artifact sounds picked up by a stethoscope or microphone are frequent and loud compared to true bowel sounds, and they generally sound similar. Patients also move and turn frequently, causing further artifacts that can obscure or "drown out" any true bowel sounds. Another problem or difficulty in recording sounds in a hospital ward is privacy and confidentiality issues, with the result that, to date, there is no commonly used automated method for bowel sound detection. The "gold standard" method for determining intestinal motility involves the use of a radioactive tracer and a gamma camera with scintigraphy. These are mainly used for research, but given their resource requirements, the use of radioactive materials, and the necessity for the patient to swallow the tracer when intestinal function has not yet been established, they are rarely applicable to postoperative clinical practice.

[0009] Some researchers have proposed methods for evaluating intestinal motility that require the patient to ingest a large volume (e.g., several hundred mL) of a "contrast" agent with a high salt content to provide an indication of gastric emptying. This is not suitable for postoperative patients as it requires the ingestion of a large volume of salty fluid, especially when the recovery of gastrointestinal function has not been confirmed in the early postoperative period. Additionally, the contrast agent makes it rather difficult for the patient to swallow due to its salty taste, and this does not increase the attractiveness of the method. This is especially so in the patient population as it increases the risk of nausea and vomiting, which is already high in this patient population (i.e., patients who have undergone surgery). Aspiration pneumonia is a significant cause of morbidity and mortality after general surgery, and its risk increases with vomiting.

[0010] Other researchers have, in the recent past, described auscultation methods that rely on piezoelectric transducers (i.e., acting as microphones or acoustic energy sensors) to perform signal processing to detect gastrointestinal motility and irritable bowel syndrome. Although this work has been ongoing for some time, as illustrated in U.S. Patent Application Publication No. US 2008 / 0253535A1, it has not matured into a commercially available product.

[0011] With the rapid development of electrocardiogram (ECG), some attempts have been made to use electrogastrogram (EGG) as a non-invasive technique to detect and record gastric myoelectric activity via electrodes placed on the abdominal surface. That is, the electrodes are adapted to detect and acquire natural electrophysiological data from the subject under study. An example is described in U.S. Patent Application Publication No. US 2018 / 0317800A1. Importantly, it has not been determined which myoelectric variables EGG can reliably record or how EGG is related to gastric motility and gastric emptying.

[0012] In other work, a system for monitoring colonic motility by means of electrode pairs placed on the posterolateral (hip) region of the body in the pelvic area of the subject is described in U.S. Patent Application Publication No. US 2020 / 0253535A1. Importantly, this system is not suitable for detecting or evaluating gastrointestinal motility in the gastric and / or pyloric regions of the patient.

[0013] There is a desire to provide a new method and system for evaluating the intra-abdominal or gastrointestinal health of a patient, particularly gastrointestinal motility. More specifically, there is a desire to provide a method and system for assessing the function and dysfunction of the stomach, small intestine, or peritoneum, particularly changes in gastrointestinal motility or function in this region of the patient. In this context, there is a desire to provide a method and system that can evaluate peristalsis at the gastric and / or pyloric regions and that does not rely on sound analysis. SUMMARY OF THE INVENTION

[0014] According to one aspect, the present disclosure provides a method for assessing abdominal health, in particular for evaluating the function or dysfunction of the stomach, small intestine, or peritoneum, and especially for assessing gastrointestinal motility or functional changes in this area, including:

[0015] Applying at least two electrodes to a patient's abdomen, and preferably to opposite sides of the abdomen (e.g., the anterior / front side and the dorsal / rear side);

[0016] Providing a current signal to the electrodes for supplying current to the abdomen; and

[0017] Determining or measuring the electrical conductivity of the abdomen along the current path between the electrodes;

[0018] Evaluating the change in the electrical conductivity of the abdomen determined or measured over a period of time, wherein the change in the electrical conductivity of the abdomen over a period of time provides an indication of abdominal or gastrointestinal function, especially an indication of the function of the stomach, small intestine, or peritoneum.

[0019] The at least two electrodes include at least one electrode for supplying current to the abdomen and at least one electrode for receiving current along the current path through the abdomen. For purposes of description, the at least one electrode for supplying current to the abdomen will be referred to as the "driving electrode", and the at least one electrode for receiving current along the current path through the abdomen will be referred to as the "sensing electrode". It should be understood that the driving electrode and the sensing electrode can be substantially the same. In addition, when connected in a circuit with an alternating current (AC) source, the reference to the "driving" electrode or "sensing" electrode in the method or system of the present disclosure is purely conceptual, since any electrode in the electrode pair that operates as the "driving" electrode or "sensing" electrode can simply vary over time (i.e., alternate).

[0020] In an embodiment, the step of applying the electrodes to the patient's abdomen (preferably to opposite sides of the abdomen) is adapted to maximize the current passing through the gastrointestinal tract. This step may include applying the electrodes in the regions of the patient's stomach, pyloric antrum, duodenum, and / or at the level of the patient's kidneys. In the context of the present disclosure, those skilled in the art will understand that the outlet of the stomach (i.e., the pylorus) has a clearly defined anatomical position (i.e., the pyloric plane). This is different from other parts of the digestive tract, which are more mobile. In addition, since the pylorus is at the top of the digestive tract, any blockage in any part of the digestive tract will cause the pylorus to stop delivering substances into the duodenum. Therefore, the present disclosure can use this position to monitor intestinal motility. If peristalsis occurs at the level of the pylorus, it can be inferred that there must be no downstream problems with intestinal motility.

[0021] Thus, for example, the electrodes may be arranged to measure the conductivity of the stomach and / or duodenum at the pyloric sphincter. It should be noted that conductivity measurements will typically vary from individual to individual depending on the individual's physiology, but also depending on the individual's intake of food and liquids. Thus, the systems and methods of the present disclosure relate to monitoring an individual over a period of time to track changes in the individual's conductivity measurements, rather than for a specific absolute value to be measured or determined. Changes in conductivity measured or determined by the electrodes may be due to fluid movement in the body. In the case where a change is detected at the pyloric sphincter, it can be inferred that the change has occurred due to fluid transfer across the pyloric sphincter. Thus, this can indicate peristalsis, which can be flagged for medical personnel to confirm.

[0022] In an embodiment, the step of providing a current signal (preferably an alternating current signal) to the electrodes includes providing the signal intermittently or at intervals over a period of time, and the step of determining or measuring the conductivity of the abdomen along the current path between the electrodes includes periodically determining or measuring the conductivity over a period of time. In this regard, when a signal is applied to the electrodes, the step of determining or measuring the conductivity is performed via a meter or sensor.

[0023] In an embodiment of the present disclosure, the step of applying the electrodes to the patient's abdomen and preferably to opposite sides of the abdomen includes: applying one electrode on a first side of the abdomen (e.g., the dorsal or posterior side), and applying at least two other electrodes spaced apart from each other (preferably in the range of about 100 mm to about 500 mm) on a second side of the abdomen (e.g., the ventral or anterior side). In this case, each of the ventral electrodes will typically receive current from the dorsal electrode along a diverging or separate current path through the abdomen. Preferably, the step of determining or measuring the conductivity is performed sequentially (e.g., via a meter or sensor) between each of the ventral electrodes and the dorsal electrode. That is, the electrode pairs (i.e., the dorsal electrode and each ventral electrode) are interrogated sequentially to determine or measure the conductivity along separate current paths.

[0024] In an embodiment of the present disclosure, the step of applying the electrodes to the patient's abdomen and preferably to opposite sides of the abdomen includes: applying at least two (driving) electrodes spaced apart from each other (preferably in the range of about 100 mm to about 500 mm) on a first side of the abdomen (e.g., the dorsal or posterior side), and applying at least two (sensing) electrodes spaced apart from each other (preferably in the range of about 100 mm to about 500 mm) on a second side of the abdomen (e.g., the ventral or anterior side). In this case, each electrode pair (e.g., each of the dorsal electrodes paired with a corresponding one of the ventral electrodes) is adapted to measure the conductivity along a separate or at least partially separate current path through the abdomen.

[0025] In past work, a researcher (Sutton) used Kelvin (four-terminal) impedance measurements to obtain gastric impedance across a discrete current path. This disclosure relates to measuring or determining conductivity (reciprocal value), and uses multiple multi-terminal measurements (e.g., two, three, or four) rather than a single four-terminal measurement. The anatomical locations of interest in this disclosure are also different from those studied by Sutton. Additionally, the methods and systems of this disclosure do not rely on the use of a contrast agent (e.g., a low-conductivity contrast agent) that the patient is required to ingest for Sutton's work, which, as noted above, is generally medically undesirable for postoperative patients. Using the systems and methods of this disclosure, the patient does not need to consume a contrast agent for the study. Instead, the methods and systems rely on the time difference between signals across different conductivity paths to evaluate gastrointestinal motility and / or intra-abdominal function. In particular, the methods and systems of this disclosure employ different modes, namely: 1. Opposite-sign differential between different conduction paths at the same time, and 2. The change in conductivity over time along each conduction path, to evaluate the function or functional change (or conversely to deny dysfunction) of the stomach, small intestine, or peritoneum.

[0026] In an embodiment of this disclosure, the step of providing a current signal involves or includes sequentially and intermittently or at intervals providing a current signal to each of the electrodes, the current signals being offset from each other in time by a short time, e.g., less than one second, and preferably in the range of 10 ms to 500 ms. In this way, the current from one (driving) electrode is separately and sequentially received at each of the two other (sensing) electrode pairs along two corresponding current paths, and the corresponding conductivity of those current paths is determined or measured. Then, the current from another electrode is similarly sent and received sequentially or with a time offset at each of the two other (sensing) electrodes along two other current paths, and the corresponding conductivity of those current paths is then similarly determined or measured.

[0027] Thus, in an embodiment of this disclosure, the step of determining or measuring the conductivity of the abdomen includes periodically determining or measuring the conductivity between each pair of electrodes (e.g., including a "driving" electrode and a "sensing" electrode) over a period of time. The "dwell" period (i.e., the time or period during which the current is sent) on each current path between each pair of electrodes is preferably relatively short; e.g., in the range of about 1 to 10 cycles of the frequency of the alternating current. For alternating current supplied at 50 Hz, the "dwell" is preferably in the range of about 20 ms to 200 ms. Preferably, each of the corresponding pairs of electrodes is excited in a predetermined order or has a current signal applied to them. The entire sequence or "cycle" of the pairs of electrodes is preferably repeated without pause.

[0028] In embodiments of the present disclosure, the step of providing a signal includes providing an alternating current signal. However, it should be understood that the methods and systems of the present disclosure are not limited to using alternating current signals and may use other signal forms. For example, direct current signals and / or a series of customized signal forms are feasible.

[0029] In one embodiment, the step of providing a current signal includes providing a low-frequency alternating current signal and a high-frequency alternating current signal to or between electrodes for determining or measuring the low-frequency electrical conductivity of the abdomen along a current path between the electrodes and the high-frequency electrical conductivity of the abdomen along the current path between the electrodes.

[0030] In embodiments of the present disclosure, the step of determining or measuring the electrical conductivity of the abdomen includes determining or measuring the electrical conductivity along the current path for both the low-frequency alternating current signal and the high-frequency alternating current signal, wherein the total electrical conductivity of the abdomen along the current path is based on the electrical conductivity measurements for both the low-frequency signal and the high-frequency signal. Thus, determining or measuring the electrical conductivity along the current path is via a dual-frequency arrangement with a low-frequency alternating current signal and a high-frequency alternating current signal. By employing both low-frequency current signals and high-frequency current signals, the dual-frequency conductivity difference can be used to evaluate gastrointestinal motility, the presence of gastrointestinal wall swelling, or ascites characteristics or changes in peritoneal function. High-frequency conductivity measurements provide information about the tissue between two given electrodes, while low-frequency conductivity measurements provide information about extracellular fluid that is moved by peristalsis through the same region between the two electrodes.

[0031] In embodiments of the present disclosure, the step of providing an alternating current signal to at least one electrode pair includes providing a low-frequency alternating current signal to at least one electrode pair that is less than about 5 kHz, preferably in the range of about 200 Hz to about 2 kHz. Thus, the step of providing a dual-frequency alternating current signal to each electrode pair includes a low-frequency AC signal that is less than about 5 kHz, preferably about 200 Hz to about 2 kHz.

[0032] In embodiments of the present disclosure, the step of providing an alternating current signal to at least one electrode pair includes providing a high-frequency alternating current greater than about 5 kHz, preferably in the range of about 5 kHz to about 50 kHz, and more preferably about 20 kHz, to at least one electrode pair. Thus, the step of providing a dual-frequency alternating current signal to each electrode pair includes a high-frequency AC signal greater than about 5 kHz, preferably about 5 kHz to about 50 kHz. This high-frequency range provides the ability to evaluate extracellular fluid levels.

[0033] In embodiments of the present disclosure, the step of determining or measuring the electrical conductivity of the abdomen across all electrodes is performed at least 5 times per second, preferably multiple times per second, and more preferably in the range of 5 to 30 times per second.

[0034] In embodiments of the present disclosure, the step of providing an alternating current signal includes providing a current signal to at least one drive electrode with a current less than or equal to about 10 mA. At relatively high signal frequencies (such as above 10 kHz), a current of up to 10 mA may be acceptable. On the other hand, as long as the signal frequency is also low (e.g., up to about 800 Hz), the current can be quite low, for example, preferably less than or equal to about 100 μA. It should be noted that at higher frequencies (e.g., above 1 kHz), the current may be greater without stimulating the neuromuscular junctions in the electrode area, which may cause irritation or discomfort to the patient. Thus, generally smaller currents are preferred, but there is a trade-off between accurate measurement of conductivity (which typically requires higher currents) and avoidance of irritation (which typically requires lower currents). The IEC 60601-1 standard for medical electrical equipment provides guidance on suitable currents and frequencies for patient use safety.

[0035] In past work, Sutton used a single excitation frequency (100 kHz) for impedance measurements. In contrast, the methods and systems of the present disclosure desirably use a dual-frequency arrangement with both low-frequency and high-frequency signals to measure conductivity. This provides the ability to measure extracellular fluid levels that could not be performed with previous measurements and simultaneously provides a baseline measurement for comparing the conductivity along each current path. Sutton's previous work involved a continuous excitation current of 4 mA at 100 kHz. In contrast, the present disclosure uses regulated pulsed currents at both low and high frequencies designed to avoid neuromuscular stimulation.

[0036] In an embodiment, the method of the present disclosure includes features and techniques for addressing three main artifact causes of conductivity variations in the abdomen, namely (i) respiration (or speaking or coughing), (ii) overall body movement (sitting up, rolling over, etc.), and (iii) heartbeat (i.e., the aorta pulsates and causes measurable conductivity variations). Starting with the heartbeat, this can be captured or detected by recording the heart rate from an ECG signal. The heart rate is typically at a level of about 1 Hz to 3 Hz, and can be functionally eliminated by determining or measuring the conductivity of the abdomen across the electrodes and averaging at 0.3 Hz. A triaxial accelerometer placed on the patient (e.g., at the electrode locations) can be used to account for overall body movement. If the accelerometer indicates movement above a threshold level (e.g., above or below the ambient level of 0.1 g for a body at rest), the conductivity measurement can be ignored until the accelerometer reading returns to the ambient or "normal" level of a body at rest. Respiratory artifacts are more difficult to interpret or "isolate" or "capture". Since respiration is a large signal with a period of about 2 to 5 seconds, a box detector can be used to synchronize with respiration and invert the variations. This removes most of the effects, but respiratory rate variations and / or speaking may still produce anomalies. During speech, the patient's diaphragm will move in an irregular manner, with occasional rapid variations in conductivity (e.g., at the end of a sentence or during a pause) interspersed with slow, measured diaphragm movements that produce little conductivity change. It is expected that such artifacts can be addressed in a manner similar to overall body movement, i.e., by a speech detector that can indicate when to ignore the conductivity measurement.

[0037] According to another aspect, the present disclosure provides a system for assessing or evaluating the function, functional alterations, or dysfunctions of a patient's small intestine, stomach, and peritoneum, particularly for assessing or evaluating a patient's gastrointestinal motility. The system includes: at least one pair of electrodes adapted to be applied to the patient's abdomen, preferably to opposite sides of the abdomen, the pair of electrodes for supplying and receiving current along a current path through the abdomen; a current source for providing a current signal to at least one of the electrodes of the pair of electrodes; an instrument or sensor for determining or measuring the conductivity of the abdomen along the current path between the electrodes; and a processor for analyzing and / or evaluating the conductivity of the abdomen determined or measured by the instrument or sensor over a period of time to provide an assessment of gastrointestinal health, particularly for detecting alterations in the function of the stomach, small intestine, or peritoneum. To this end, variations in the conductivity of the abdomen in the region of the stomach, small intestine, or peritoneum over a period of time can provide an indication of gastrointestinal motility and / or function within that region.

[0038] According to yet another aspect, the present disclosure provides a device for detecting the function / dysfunction (particularly gastrointestinal motility) of a patient's stomach, small intestine, or peritoneum, the device including:

[0039] A current source adapted to provide or apply a current signal to or between at least one pair of electrodes adapted to be applied to a patient's abdomen;

[0040] An instrument or sensor for determining or measuring the electrical conductivity of the abdomen along a current path between the electrodes; and

[0041] A processor for analyzing the electrical conductivity of the abdomen determined or measured by the instrument or sensor over a period of time to provide an assessment of gastrointestinal motility or dysfunction.

[0042] In an embodiment of the present disclosure, the current source is adapted to provide or apply an alternating current signal to or between the pair of electrodes. However, it should be understood that the present disclosure is not limited to the use of alternating current signals, and other signal forms may be used. For example, direct current signals and / or a series of customized signal forms are feasible. At least one of the electrodes typically supplies current to the abdomen, and at least one of the electrodes receives current along the current path through the abdomen.

[0043] In an embodiment of the present disclosure, the system or device includes a memory, particularly a digital memory or storage device, for recording or storing the electrical conductivity of the abdomen determined or measured over a period of time along a current path between at least one pair of electrodes. In this way, the memory can store the usage history of the system for one or more patients. The memory may include, for example, the random access memory of the processor, or alternatively a flash drive or some other storage device. The system or device is preferably connectable (e.g., physically, directly, or wirelessly) to a display or printer for displaying or printing the assessment or evaluation results of the function, functional changes, or dysfunction of the stomach, small intestine, or peritoneum of one or more patients, particularly the assessment or evaluation results of gastrointestinal motility recorded over a period of time.

[0044] In an embodiment of the present disclosure, the system and device may be adapted to communicate and / or interact with one or more remote devices or mobile devices. In this regard, the system and / or device of the present disclosure preferably includes a software application for supporting remote access by one or more individuals to the analysis and measurement of the system or device. For example, the software application may be accessed or operated via a mobile telecommunications device ("mobile device") such as a smart phone or tablet. In this way, the analysis and / or measurement of the system from one or more patients can be made available or transmitted to medical professionals located away from the patients.

[0045] In an embodiment of the present disclosure, a current source is adapted to provide a low-frequency alternating current signal to at least one drive electrode, preferably less than about 5 kHz, and more preferably in the range of about 200 Hz to 2 kHz. The low-frequency alternating current signal is preferably provided within a dual-frequency arrangement.

[0046] In an embodiment, a current source is adapted to provide a high-frequency alternating current signal to at least one drive electrode, preferably greater than about 5 kHz, more preferably in the range of about 5 kHz to about 50 kHz, and even more preferably about 20 kHz. The high-frequency alternating current signal is preferably provided within a dual-frequency arrangement.

[0047] In an embodiment of the present disclosure, an instrument or sensor is adapted to determine or measure (e.g., in dual-frequency operation) the electrical conductivity of the abdomen along a current path between electrodes for both a low-frequency alternating current signal and a high-frequency alternating current signal. In this way, the "normal" or total electrical conductivity of the abdomen along the current path can be based on conductivity measurements of both the low-frequency and high-frequency signals. Preferably, as described above, with reference to the IEC 60601-1 standard, the current source is adapted to provide an alternating current signal to at least one electrode pair, with a current less than or equal to about 10 mA for the high-frequency AC signal and less than or equal to about 100 μA for the low-frequency AC signal.

[0048] In an embodiment, the sensor is adapted to determine or measure the electrical conductivity of the abdomen between at least one electrode pair multiple times per second (and desirably at least 5 times per second). To this end, the sensor desirably interrogates or samples the electrodes at a rate in the range of 5 to 30 times per second. By sampling or interrogating the electrodes to measure the conductivity multiple times per second, the effects of other biological movements or biological signals (such as cardiac signals) can be eliminated from the measurements. In this regard, samples taken at a rate of five times per second enable addressing of cardiac signals, although sampling at a higher rate is better, e.g., 10 times per second or 20 times per second. Other biological signals from humans typically have lower frequencies, e.g., respiration is about 0.2 Hz.

[0049] In an embodiment, at least one electrode pair includes at least four electrodes, including at least two electrodes adapted to be applied spaced apart from each other on a first side (e.g., dorsal or posterior side) of the abdomen, and at least two electrodes adapted to be applied spaced apart from each other on a second opposite side (e.g., ventral or anterior side) of the abdomen. Each of the sensing electrodes receives current from each of the drive electrodes along a separate or different current path through the abdomen. Preferably, the current source is adapted to intermittently or periodically and offset from each other (i.e., in sequence) provide an alternating current signal to each of the drive electrodes. The instrument or sensor will preferably periodically determine or measure the electrical conductivity of the abdomen along each current path between the electrodes.

[0050] As described above, the electrodes are adapted to be applied to opposite sides of a patient's abdomen in the regions of the stomach, pyloric antrum, duodenum, and / or at the level of the kidneys.

[0051] In an embodiment, the methods and systems of the present disclosure measure multiple individual current paths in a "round-robin" fashion. A complete measurement of multiple paths occurs several times per second. This involves multiple low-frequency measurements of conductivity, multiple high-frequency measurements of conductivity, and preferably also involves a reference measurement of a locally fixed (constant) internal resistance to confirm proper operation of the system.

[0052] According to another aspect, the present disclosure provides electrodes for a system designed to evaluate or assess gastrointestinal health, particularly the function, functional changes, or dysfunction of the stomach, small intestine, or peritoneum, and particularly for assessing gastrointestinal motility of a patient. The electrodes include: at least one electrode pair adapted to be applied to a patient's abdomen, and preferably to opposite sides of the abdomen, wherein at least one of the electrodes (e.g., as a drive electrode) is used to supply current to the abdomen, and at least one of the electrodes (e.g., as a sense electrode) is configured to receive current along a current path through the abdomen. The electrodes are designed to be connected to a current source to supply a current signal to the electrodes, and to be connected to an instrument or sensor to determine or measure the conductivity of the abdomen along the current path between the electrodes. As described above, the determined or measured output conductivity between the electrodes is analyzed or evaluated over a period of time to assess gastrointestinal health, particularly potential dysfunction in the regions of the stomach, small intestine, or peritoneum. To this end, the change in the measured conductivity over time can provide an indication of changes in the function or dysfunction of the patient's stomach, small intestine, or peritoneum, particularly gastrointestinal motility and function within this region.

[0053] The electrodes of the electrode pair will be particularly suitable for the systems and methods of the present disclosure. To this end, the calibration of an instrument or sensor for determining or measuring the electrical conductivity of the abdomen along the current path between the electrodes, and the calibration of a processor for analyzing and / or evaluating the electrical conductivity of the abdomen determined or measured by the instrument or sensor over a period of time (these calibrations are for providing an assessment of gastrointestinal motility, in particular for detecting functions or dysfunctions in the regions of the stomach, small intestine or peritoneum), are generally very sensitive to changes in the electrodes. For this reason, the electrodes of the systems and methods of the present disclosure will be standardized to minimize sources of variability that may confound the measurements or test results obtained. For example, the type of electrode, its structure, size and geometry, and its interaction with the patient's skin (e.g., via a conductive gel pad) are expected to be crucial for the reliable functioning of the systems and methods. For this reason, the electrodes are ideally standardized. It should be understood that, given the various medical applications of such electrodes, the features of electrode designs for use on the human body, in particular for electrodes designed for conductive application to the human skin, are quite well established. An example in this regard is the electrodes for electrocardiogram (ECG). In this particular case, the electrodes are used to receive or detect the electrical activity of the heart, rather than to apply current to the body, but the features of the conductive connection to the skin are still relevant.

[0054] In an embodiment, the electrodes may be serialized or encoded for compatibility with the processor and / or for compatibility with the instrument or sensor of the system. In this way, the systems of the present disclosure can be adapted to operate only with electrodes that are "recognized" by the system and are compatible with the system; that is, for which the system has been designed and calibrated to minimize sources of variability or error in patient measurements or test results. All electrodes may be substantially identical in structure.

[0055] According to another aspect, the present disclosure provides a method for assessing or evaluating the intra-abdominal health of a patient, in particular the function, functional changes or dysfunctions of the stomach, small intestine or peritoneum, in particular gastrointestinal motility, comprising:

[0056] Storing electronic program instructions for controlling a controller; and

[0057] Controlling the controller via the electronic program instructions to perform the following operations:

[0058] Providing or applying a current signal to at least one electrode pair applied to the patient's abdomen or between at least one electrode pair applied to the patient's abdomen, wherein at least one electrode supplies current to the abdomen and at least one electrode receives current along the current path through the abdomen;

[0059] Determining or measuring the electrical conductivity of the abdomen along the current path between the electrodes (e.g., via an instrument or sensor); and

[0060] Analyze the electrical conductivity of the abdomen determined or measured over a period of time to provide an assessment of intra-abdominal health.

[0061] According to yet another aspect, there is provided a computer-readable storage medium having instructions stored thereon that, when run by a computing device, cause the computing device to perform a method according to an aspect of the present disclosure as described above.

[0062] According to yet another aspect, the present disclosure provides a computing device programmed to perform a method according to an aspect of the present disclosure as described above. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] To more fully understand the present disclosure and its advantages, exemplary embodiments are explained in more detail below with reference to the accompanying drawings, in which like reference numerals represent like parts, and in which:

[0064] Figure 1 is a cross-sectional image of a patient's abdomen or intestine showing an anatomical structure of interest;

[0065] Figure 2 is a schematic electrical model of the body showing two main parts or components (i.e., extracellular and intracellular) in a given region of the body as a simple parallel circuit;

[0066] Figure 3 is a schematic diagram of a system for evaluating gastrointestinal motility of a patient in use according to an embodiment of the present disclosure;

[0067] Figure 4 is a schematic diagram of a part of a system for evaluating gastrointestinal motility of a patient according to an embodiment of the present disclosure; and

[0068] Figure 5 is a flowchart schematically representing a method according to any embodiment of the present disclosure.

[0069] The drawings are included to provide a further understanding of the present disclosure, and the drawings are incorporated into and constitute a part of this specification. The drawings illustrate specific embodiments and, together with the description, are used to explain the principles of the present disclosure. Other embodiments and many attendant advantages will be readily understood as they become better understood by reference to the following detailed description.

[0070] It should be understood that common and / or well-understood elements that may be useful or necessary in commercially viable embodiments are not necessarily depicted in order to facilitate a more abstract view of the embodiments. The elements of the drawings are not necessarily shown to scale relative to each other. It will also be understood that certain acts and / or steps in embodiments of the method may be described or depicted in a particular order of occurrence, and those skilled in the art will understand that such specificity as to order is not actually required. DETAILED DESCRIPTION

[0071] First, referring to the Figure 1 , a cross-section shows the abdomen or intestine A of the patient's body B. There are some positions within the abdomen A where the relevant anatomical structures of the gastrointestinal tract are relatively invariant. These positions include the pyloric region Y of the stomach C and the duodenum. Most other parts of the gastrointestinal tract can move within the abdomen A to a certain extent. Figure 1 The cross-sectional image of the intestine A in shows the anatomical structures of interest, as well as the pancreas F. The section was taken at the level of the kidneys K (i.e., in the region from thoracic vertebra T12 to lumbar vertebra L2), and is shown as looking up from the feet towards the head, where the patient's right side is on the left hand side of the image, and the spine S is positioned towards the bottom of the image. Here, some fluid level L can be seen in the stomach C, from which we can assume that the patient is in the supine position, i.e., lying on their back.

[0072] The flow of electric current through the body is controlled by the electrical conductivity of the structures and substances located along the current path. The substances with the highest electrical conductivity in the human body are usually extracellular fluids such as urine, lymph fluid, and blood, because these substances are composed of salts, and salts are in a solution mainly of water. The next most conductive substances are usually muscles and vascular organs such as the liver or kidneys. Bones, fat, and skin are the poorest conductors. From the perspective of electrical conductivity, there are two main parts within human tissue - namely, the intracellular matrix and the extracellular matrix. The extracellular matrix / fluid includes the contents of the stomach or intestine, blood, lymph fluid within the tissue, etc. The cell membrane is a wall-like structure that surrounds the cell and holds it together, where the intracellular fluid or liquid is inside the cell. The cell membrane is composed of fat (lipids) with holes (pores) in it. Although the fat layer of the cell membrane has very poor electrical conductivity, the fluid inside the cell is a salt solution and usually has a much higher electrical conductivity. Therefore, these two parts of the tissue (in the same region of the body) can be modeled as a simple parallel circuit, as shown in the Figure 2 drawing.

[0073] Referring to the attached Figure 2 , the alternating current signal from the AC source V that is guided through the path of the extracellular matrix can be modeled as a simple resistance circuit with a resistance Re. On the other hand, the path of the alternating current signal through the intracellular matrix is modeled by a capacitor Ci in series with a resistance Ri, where the capacitor Ci represents the cell membrane. This means that low-frequency alternating current will involve lower electrical conductivity because low-frequency alternating current (e.g., <2 kHz) can only pass through the extracellular matrix, while high-frequency alternating current (e.g., >50 kHz) will involve higher electrical conductivity in the same region because some current will pass through the cell interior. Figure 2 shows the total impedance (Z) for two alternating current frequencies. Against this background, the systems and methods of the present disclosure have been developed to employ a dual-frequency arrangement.

[0074] Reference Figure 3 and Figure 4 ,a system 1 and an associated method in accordance with embodiments of the present disclosure will be described. The system 1 and method are for measuring the conductivity between electrodes D0, D1, S0, S1, which are placed and conductively applied to the skin on the back (posterior) and front (anterior) sides of the abdomen A of a patient's body B, as a device for assessing the health and activity of the gastrointestinal tract. More specifically, it indirectly assesses the peristaltic movement of the gastrointestinal tract and the movement of fluid across the pyloric sphincter or between the pyloric antrum and the duodenum, thereby evaluating the function or functional changes of the stomach, small intestine, or peritoneum. As can be seen from Figure 3 ,four electrodes D0, D1, S0, S1 are applied or placed on the abdomen A of the patient, including two drive electrodes D0, D1 and two sense electrodes S0, S1. The two drive electrodes D0, D1 are for supplying an alternating current, and the two drive electrodes D0, D1 are applied to the back or posterior side of the patient. The two sense electrodes S0, S1 are for receiving the alternating current along the current path through the abdomen, and the two sense electrodes S0, S1 are applied to the front or anterior side of the patient. All electrodes D0, D1, S0, S1 are applied at approximately the level of the kidneys (i.e., in the region from thoracic vertebra T12 to lumbar vertebra L2).

[0075] The assumed current path (labeled "P") is schematically shown as an oval region in Figure 3 。As Figure 1 shown, this view of the abdomen A is from the patient's feet looking towards the head. The electrodes D0, D1, S0, S1 are connected in pairs, where each of the dorsal (drive) electrodes D0, D1 is arranged to form a pair with each of the ventral (sense) electrodes S0, S1. In this way, there are four electrode pairs D0S0, D0S1, D1S0, D1S1. As Figure 4 shown, the system 1 includes a device 10 for detecting the function or dysfunction of the stomach, small intestine, or peritoneum, particularly for detecting gastrointestinal motility in this region of the patient's body B. The device 10 includes a current source 11 and a meter or sensor 12. The current source 11 is adapted to supply or apply an alternating current signal to each pair of the electrodes D0, D1, S0, S1 applied to the front and back sides of the abdomen A of the patient's body. The meter or sensor 12 is for determining or measuring the current along the current path P 00 、P 01 、P 10 、P 11The conductivity of the abdomen A. When a current is applied between any pair of any of the corresponding electrodes D0, D1, S0, S1, the electrodes are also interrogated by the meter or sensor 12. The provision of the current signal by the current source 11 and / or the interrogation or sampling by the meter or sensor 12 occur periodically at a rate in the range of 5 to 30 samples per second. Sampling at these rates enables the elimination of the patient's cardiac signal from the measurement at a higher sampling rate, thus more effectively solving the problem. Each electrode pair D0S0, D0S1, D1S0, D1S1 has both a low-frequency alternating current signal of approximately 200 Hz and a high-frequency alternating current signal of approximately 50 kHz applied intermittently and sequentially via the current source 11. For both the high-frequency current signal and the low-frequency current signal (as the high-frequency conductivity σ hi and the low-frequency conductivity σ lo ), the conductivity of each current path P 00 、P 01 、P 10 、P 11 is measured. The offset conductivity σ 偏移 is determined as the offset at time T set , which time T set is set for the start of the case evaluation, and during the remainder of the case evaluation, the normal or total conductivity is compared with this reference value.

[0076] Generally speaking, for each current path P 00 、P 01 、P 10 、P 11 shown for the electrode pairs D0S0, D0S1, D1S0, D1S1, the low-frequency conductivity σ hi is subtracted from the high-frequency conductivity σ lo . Then a normal conductivity or total conductivity is created for each path, which should be close to the numerical value zero, and then the conductivity changes between the four paths P 00 、P 01 、P 10 、P 11 are observed over time.

[0077] σ 偏移 (T set )=σ hi (T set )-σ lo (T set )(Equation 1)

[0078] σ 总 =σ hi -σ lo -σ 偏移 (T set )(Equation 2)

[0079] The expected conductivity is expected to change slowly in a sequential manner over a period of several tens of seconds (e.g., between 10 seconds and 30 seconds). As the conductivity of the path P between the measured or determined electrode pair D0S1 01 increases, it can be expected that the stomach has forced more liquid into the pyloric antrum. And as the conductivity of the path P 01 between the measured or determined electrode pair D0S1 (showing the liquid in the duodenum) increases, it can be expected that the conductivity of the path P 00 between the measured or determined electrode pair D0S0 should decrease. This is because the liquid has now been forced to pass from the pyloric antrum through the sphincter into the duodenum.

[0080] The electrode pair D1S1 measures the conductivity through the stomach, and in this particular case, this conductivity may be less than the conductivity measured by the electrode pair D0S1 because there is gas at the top of the stomach (i.e., assuming the patient is in a supine position). However, this lower conductivity measurement at D1S1 can also simply indicate that the electrode S1 is shifting. If this occurs, the conductivity measured or determined by each of the two electrode pairs D0S1 and D1S1 will decrease. However, in the case where the changes in the conductivity measured or determined by the respective electrode pairs D0S0, D0S1, D1S0, D1S1 are due to the movement of liquid in the body B, one would expect a complementary (contradictory) change in conductivity, i.e., the value of the conductivity between one electrode pair rises while the value of the conductivity between the other pair falls. The same should also occur for the other electrode pairs D0S0 and D1S0. If the conductivity measured or determined between both of these electrodes D0S0, D1S0 decreases, electrode failure or disconnection can be suspected. But if the conductivity between one electrode pair rises while the conductivity between the other electrode pair falls, it can be concluded that there is movement of liquid through the pyloric sphincter, which subsequently provides an indication or potential indication of gastrointestinal forward transport. The evidence of transport can then be marked for confirmation by medical professionals, who can then examine the records, evaluate the evidence, and confirm or deny based on their clinical judgment.

[0081] Four separate current paths P 00 、P 01 、P 10 、P 11The conductivity between each of the electrode pairs D0S0, D0S1, D1S0, D1S1 is measured in a "cyclic" manner in a repeating sequence, where a complete measurement is made of each of the four current paths at least every 200 milliseconds. This in turn corresponds to at least five complete measurements per second. The sequence involves four low-frequency measurements of the conductivity across each electrode pair, four high-frequency measurements of the conductivity across each electrode pair, and two measurements of a local internal fixed or invariant resistance to ensure proper device function in each 200 millisecond cycle. As mentioned above, a higher sampling rate enables more effective elimination of the patient's cardiac signal from the measurements, and schemes with up to 30 complete measurements per second have been tried (i.e., a complete measurement is made of the four current paths P 00 , P 01 , P 10 , P 11 every 33 milliseconds).

[0082] Referring to the accompanying drawings Figure 4 , there is shown a simple circuit diagram to illustrate the system 1 of the preferred embodiment. The system 1 has drive electrodes D0, D1 connected in the circuit to sensing electrodes S0, S1 (the dotted lines indicate their positioning hidden on the dorsal or posterior side of the patient's body B), where all electrodes D0, D1, S0, S1 are connected via two eight-channel multiplexers 13, 14 to a current source 11 for switching between the corresponding electrode pairs D0S0, D0S1, D1S0, D1S1. Two resistors R1, R2 are provided as local internal fixed or invariant resistors for calibration and continuous reference or cross-check during the use of the system 1. The device 10 includes a current source 11 for providing an AC signal to the electrode pairs D0S0, D0S1, D1S0, D1S1, and an instrument or sensor 12 for periodically interrogating those electrode pairs at a rate in the range between 5 and 30 samples per second to measure or determine the conductivity along the current paths P 00 , P 01 , P 10 , P 11 of each of the corresponding electrode pairs D0S0, D0S1, D1S0, D1S1. A processor 15 (with memory) is incorporated into the device 10 for recording or storing the values of the conductivity measured or determined by the instrument 12 during the patient monitoring period. In addition, the processor 15 is adapted to analyze the conductivity of the abdomen A determined or measured by the instrument or sensor 12 during that time period, particularly the change in conductivity determined or measured along the corresponding current paths P 00 , P 01 , P 10 , P 11 to evaluate and / or detect the function or functional changes of the stomach, small intestine, or peritoneum.

[0083] Finally, with reference to the accompanying drawings Figure 5 , a flow chart is shown, which schematically shows the steps in a method for assessing or evaluating the function, functional changes or dysfunctions (especially gastrointestinal motility) of a patient's stomach, small intestine and peritoneum, according to the embodiments of the present disclosure described above with respect to Figures 1 to 4 . In this regard, Figure 5 the first box i of represents the step of applying electrodes D0, D1, S0, S1 to the patient's abdomen, the electrodes including at least one electrode D0, D1 applied to the dorsal side of the abdomen and at least one electrode S0, S1 applied to the ventral side of the abdomen, for passing or conducting an electric current through the abdomen along a current path P. In a specific example, two electrodes D0, D1 are applied spaced apart on the more posterior side of the abdomen, and two electrodes S0, S1 are applied spaced apart on the more anterior side of the abdomen, wherein all electrodes D0, D1, S0, S1 are applied at the level of the kidneys. The second box ii represents the step of providing an alternating current signal to at least one of the electrodes D0, D1, wherein the current signal is provided intermittently or at intervals and sequentially or offset from each other to each of the electrodes D0, D1. Then, the third box iii represents determining or measuring the conductivity of the abdomen along each current path P 00 , P 01 , P 10 , P 11 between each pair of electrodes D0S0, D0S1, D1S0, D1S1 formed by at least one dorsal electrode D0, D1 and at least one ventral electrode S0, S1. The last box iv in the accompanying drawings Figure 5 represents the step of evaluating the change in the conductivity of the abdomen determined or measured between the electrode pairs D0S1, D150, D1S1 over a period of time, whereby the change in the conductivity of the abdomen over a period of time provides an indication of potential changes in the function or dysfunction of the stomach, small intestine and peritoneum, especially an indication of the patient's gastrointestinal motility.

[0084] Although specific embodiments of the present disclosure are shown and described herein, those of ordinary skill in the art will understand that there are various alternative and / or equivalent implementations. It should be understood that each exemplary embodiment is merely an example and is not intended to limit the scope, applicability or configuration in any way. On the contrary, the foregoing summary and detailed description will provide those skilled in the art with a convenient roadmap for implementing at least one exemplary embodiment, and it should be understood that various changes can be made to the functions and arrangements of the elements described in the exemplary embodiments without departing from the scope set forth in the appended claims and their legal equivalents. Generally, this application is intended to cover any adaptations or variations of the specific embodiments discussed herein.

[0085] The methods or processes outlined herein can be encoded as software executable on one or more processors employing any of a variety of operating systems or platforms. Additionally, such software can be written using any of a number of suitable programming languages and / or programming or scripting tools, and can also be compiled into executable machine language code or intermediate code for execution on a framework or virtual machine.

[0086] In this regard, various inventive concepts can be embodied as a computer-readable storage medium (or multiple computer-readable storage media) (e.g., computer memory, one or more floppy disks, compact disks, optical disks, magnetic tapes, flash memories, circuit configurations in a field programmable gate array or other semiconductor device, or other non-transitory media or tangible computer storage media) encoded with one or more programs that, when executed on one or more computers or other processors, perform the methods of the various embodiments of the present invention described above. One or more computer-readable media can be removable, such that the one or more programs stored thereon can be loaded onto one or more different computers or other processors to implement the various aspects of the present invention as described above.

[0087] The term "program" or "software" is used herein in a general sense to refer to any type of computer code or set of computer-executable instructions that can be used to program a computer or other processor to implement the various aspects of the embodiments described above. Additionally, it should be understood that, according to one aspect, one or more computer programs that, when executed, perform the methods of the present invention need not reside on a single computer or processor, but can be distributed in a modular fashion among a number of different computers or processors to implement the various aspects of the present invention.

[0088] Computer-executable instructions can be in many forms, such as program modules, executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Generally, the functionality of program modules can be combined or distributed as desired in various embodiments.

[0089] In addition, data structures can be stored in a computer-readable medium in any suitable form. For simplicity of illustration, a data structure can be shown as having fields related by their positions in the data structure. Such relationships can equally be achieved by allocating storage for the fields in a computer-readable medium having positions that convey relationships between the fields. However, any suitable mechanism can be used to establish relationships between the information in the fields of a data structure, including by using pointers, tags, or other mechanisms that establish relationships between data elements.

[0090] It should also be understood that, unless the context requires otherwise, the terms "including", "comprising", "containing", "having", "with" and any variations thereof used in this document are intended to be understood in an inclusive (i.e., non-exclusive) sense, such that the processes, methods, devices, apparatuses or systems described herein are not limited to the recited features, integers, components, elements or steps, but may include other features, integers, components, elements or steps not expressly listed and / or inherent to such processes, methods, devices, apparatuses or systems. Additionally, unless expressly stated otherwise, the terms "a" and "an" used herein are intended to be understood as meaning one or more. Further, references to positional terms (such as "below" and "above") used in the foregoing description will be in the context of the embodiments depicted in the drawings and should not be taken as limiting the disclosure to a literal interpretation of the terms, but as understood by those skilled in the art in an appropriate context.

Claims

1. A system for evaluating or detecting the function or functional changes of the small intestine, stomach or peritoneum of a patient, comprising: At least one pair of electrodes, the pair of electrodes being adapted to be applied to opposite sides of the abdomen of the patient for supplying and receiving current along at least one current path through the abdomen; A current source for providing or applying a current signal to or between the electrodes; An instrument or sensor for determining or measuring the electrical conductivity of the abdomen along the current path between the electrodes; And A processor for analyzing the electrical conductivity of the abdomen determined or measured by the instrument or sensor over a period of time to detect the function and functional changes of the stomach, small intestine or peritoneum.

2. The system according to claim 1, wherein The current source is adapted to provide both a low-frequency alternating current signal and a high-frequency alternating current signal to or between the electrodes in a dual-frequency arrangement to determine or measure both the low-frequency electrical conductivity of the abdomen along the current path between the electrodes and the high-frequency electrical conductivity of the abdomen along the current path between the electrodes.

3. The system according to claim 1 or 2, wherein The current source is adapted to provide a low-frequency alternating current signal to the electrodes that is less than about 5 kHz and preferably between about 200 Hz and about 2 kHz.

4. The system according to any one of claims 1 to 3, wherein The current source is adapted to provide a high-frequency alternating current signal to the electrodes that is greater than about 5 kHz and preferably between about 5 kHz and about 50 kHz.

5. The system according to any one of claims 1 to 4, wherein The sensor or instrument is adapted to determine or measure the electrical conductivity of the abdomen along the current path between the electrodes for both the low-frequency alternating current signal and the high-frequency alternating current signal in the dual-frequency arrangement, wherein the total electrical conductivity of the abdomen along the current path is based on the electrical conductivity measurements for both the low-frequency signal and the high-frequency signal.

6. The system according to any one of claims 1 to 5, wherein The current source is adapted to provide an alternating current signal to the electrodes with a current of at least one pair of electrodes, with a current less than or equal to about 10 mA for high-frequency signals of 10 kHz or greater, and / or a current less than or equal to 100 μA for low-frequency signals of less than 2 kHz.

7. The system according to any one of claims 1 to 6, wherein, The sensor is adapted to determine or measure the electrical conductivity of the abdomen between the at least one pair of electrodes at least 5 times per second and preferably in the range of 5 to 30 times per second.

8. The system according to any one of claims 1 to 7, wherein, The at least one pair of electrodes includes four electrodes, including two electrodes adapted to be applied on the first (e.g., posterior) side of the abdomen at a distance spaced apart within a range of about 100 mm to about 500 mm from each other, and two electrodes adapted to be applied on the second (e.g., anterior) opposite side of the abdomen at a distance spaced apart within a range of about 100 mm to about 500 mm from each other, wherein each of the second-side electrodes forms an electrode pair with each of the first-side electrodes and receives current from each of the first-side electrodes along a separate or different current path through the abdomen.

9. The system according to claim 8, wherein, The current source is adapted to intermittently or at intervals and sequentially or offset from each other to provide the alternating current signal to each electrode.

10. The system according to claim 8 or 9, wherein, The meter or sensor is adapted to periodically and successively determine or measure the conductivity of the abdomen along each of the current paths between the electrode pairs.

11. The system according to any one of claims 1 to 10, wherein, The at least one electrode pair is adapted to be applied to opposite sides of the abdomen in a region of the patient's stomach, pyloric antrum, duodenum, and / or kidney.

12. The system according to any one of claims 1 to 11, further comprising a triaxial accelerometer placed on the patient to detect overall body movement and taking into account the overall body movement in the analysis of the conductivity of the abdomen measured or determined over the period of time.

13. A method of evaluating or detecting the function or functional changes of a patient's small intestine, stomach, or peritoneum, in particular gastrointestinal motility in this region, comprising the steps of: applying electrodes to opposite sides of the abdomen of the patient, and in particular in a region of the patient's stomach, pyloric antrum, duodenum, and / or at the level of the patient's kidney, the electrodes comprising at least one electrode for supplying current to the abdomen and at least one electrode for receiving current along a current path through the abdomen; providing a current signal to the electrodes; and determining or measuring the conductivity of the abdomen along the current path between the electrodes, wherein a change in the conductivity of the abdomen measured or determined over a period of time provides an indication of the function or functional changes of the small intestine, stomach, or peritoneum.

14. The method according to claim 13, wherein, The step of applying electrodes to opposite sides of the abdomen of the patient comprises applying two electrodes spaced apart from each other on a first side of the abdomen and two electrodes spaced apart from each other on a second side of the abdomen, wherein each second side electrode forms an electrode pair with each first side electrode and receives current from each of the first side electrodes along a separate or different current path through the abdomen.

15. The method according to claim 14, wherein The step of providing the current signal comprises intermittently or at intervals and successively or offset from each other providing the current signal to each of the electrodes; and / or wherein the step of providing the current signal comprises providing a low-frequency alternating current signal and a high-frequency alternating current signal to the electrodes or between the electrodes for determining or measuring the low-frequency conductivity of the abdomen along the current path between the electrodes and the high-frequency conductivity of the abdomen along the current path between the electrodes.

16. The method according to any one of claims 13 to 15, wherein, The step of determining or measuring the conductivity of the abdomen comprises periodically determining or measuring the conductivity between the electrodes over the period of time, the electrodes preferably being electrodes of an electrode pair, wherein each pair comprises one of each of the first side electrodes and one of each of the second side electrodes.

17. The method according to any one of claims 13 to 16, wherein The step of determining or measuring the conductivity of the abdomen comprises determining or measuring the conductivity along the current path for both a low-frequency AC signal of less than about 5 kHz and a high-frequency AC signal of greater than about 10 kHz in a dual-frequency system, wherein the total conductivity of the abdomen along the current path is based on conductivity measurements for both the low-frequency signal and the high-frequency signal.

18. The method according to any one of claims 13 to 17, wherein The step of providing a current signal to the electrodes includes providing a low-frequency AC signal to the electrodes that is less than about 5 kHz, preferably in the range of about 200 Hz to about 2 kHz.

19. The method according to any one of claims 13 to 18, wherein The step of providing the current signal to the electrodes includes providing a high-frequency AC signal to the electrodes that is greater than about 10 kHz, preferably in the range of about 20 kHz to about 50 kHz, and more preferably about 50 kHz.

20. The method according to any one of claims 13 to 19, wherein, The step of determining or measuring the conductivity of the abdomen is performed at least 5 times per second and preferably in the range of 5 to 30 times per second.

21. The method according to any one of claims 13 to 20, wherein The step of providing the current signal includes providing the current signal to the electrodes with a current that is less than or equal to about 10 mA and preferably less than or equal to about 100 μA.

22. The method according to any one of claims 13 to 21, wherein, The step of applying the electrodes to opposite sides of the patient's abdomen includes applying the electrodes in the regions of the patient's stomach, pyloric antrum, duodenum, and / or kidneys.

23. A method for evaluating or detecting the function or functional changes of a patient's small intestine, stomach, or peritoneum, especially for evaluating gastrointestinal motility in this region, includes the following steps: Applying electrodes to opposite sides of the patient's abdomen for supplying and receiving current along at least one current path through the abdomen, especially in the regions of the patient's stomach, pyloric antrum, duodenum, and / or kidneys; Providing an alternating current signal to the electrodes; and Determining or measuring the conductivity of the abdomen along the current path between the electrodes; Analyzing the changes in the conductivity of the abdomen measured or determined along the current path over a period of time to provide an indication of the function or dysfunction of the small intestine, stomach, or peritoneum.

24. The method according to claim 23, wherein, The step of applying the electrodes to opposite sides of the patient's abdomen includes applying two electrodes spaced apart from each other on the first side of the abdomen and two electrodes spaced apart from each other on the second side of the abdomen, wherein each second-side electrode forms an electrode pair with each first-side electrode and receives current from each of the first-side electrodes along a separate or different current path through the abdomen.

25. The method according to claim 24, wherein The step of providing the current signal includes providing the current signal to each of the electrodes intermittently or at intervals and sequentially or offset from each other; and / or wherein the step of providing the current signal includes providing both a low-frequency alternating current signal and a high-frequency alternating current signal to the electrodes or between the electrodes for determining or measuring the low-frequency conductivity of the abdomen along the current path between the electrodes and the high-frequency conductivity of the abdomen along the current path between the electrodes.

26. The method according to any one of claims 23 to 25, wherein, The step of determining or measuring the conductivity of the abdomen includes periodically determining or measuring the conductivity between the electrodes as electrode pairs during the period of time, each pair including one of each first-side electrode and one of each second-side electrode.

27. The method according to any one of claims 23 to 26, wherein The step of determining or measuring the conductivity of the abdomen includes determining or measuring the conductivity along the current path for both a low-frequency AC signal of less than about 5 kHz and a high-frequency AC signal of greater than about 10 kHz in a dual-frequency system, wherein the total conductivity of the abdomen along the current path is based on conductivity measurements for both the low-frequency signal and the high-frequency signal.

28. A method for evaluating or detecting the function or functional changes of a patient's stomach, small intestine, or peritoneum, especially gastrointestinal motility in this area, comprising: Storing electronic program instructions for controlling a controller; and Controlling the controller via the electronic program instructions to perform the following operations: Providing or applying a current signal to at least one electrode pair applied to the patient's abdomen or between the at least one electrode pair, wherein at least one of the electrodes supplies current to the abdomen and at least one of the electrodes receives current along a current path through the abdomen; Determining or measuring the conductivity of the abdomen along the current path between the electrodes; and Analyzing the conductivity of the abdomen determined or measured over a period of time to evaluate or detect the function or functional changes of the stomach, small intestine, or peritoneum.

29. The method according to claim 28, wherein, The operation of determining or measuring the conductivity of the abdomen along the current path between the electrodes includes determining or measuring the conductivity along the current path for both a low-frequency AC signal of less than about 5 kHz and a high-frequency AC signal of greater than about 10 kHz in a dual-frequency system, wherein the total conductivity of the abdomen along the current path is based on conductivity measurements for both the low-frequency signal and the high-frequency signal.

30. The method according to claim 28 or 29, wherein The operation of determining or measuring the conductivity of the abdomen along the current path between the electrodes is performed at least 5 times per second and preferably in the range of 5 to 30 times per second.

31. A computer-readable storage medium having instructions stored thereon that, when run by a computing device, cause the computing device to perform the method according to any one of claims 28 to 30.

32. A computing device programmed to perform the method according to any one of claims 28 to 30.

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