Method and system for assessing intraperitoneal health - Patent Application 20070122999

Abstract

The present disclosure relates to a method for detecting function or changes in function, particularly gastrointestinal motility, of a patient's stomach, small intestine, or peritoneum, comprising the steps of: placing a plurality of electrodes on opposite sides of the patient's abdomen, the plurality of electrodes including 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; supplying an alternating current signal to the plurality of electrodes; and determining or measuring abdominal conductivity along the current path between the plurality of electrodes, wherein a change in conductivity over a predetermined period of time provides an indication of gastric, small intestinal, or peritoneal function or dysfunction. The present disclosure also provides a system for assessing function or changes in function, particularly gastrointestinal motility, of a patient's stomach, small intestine, or peritoneum.

Description

[Technical Field]

[0001] The present disclosure relates to methods and systems for assessing the health of the abdominal cavity, and in particular to methods and systems for verifying the function of the stomach, small intestine, and peritoneum. The present disclosure particularly relates to methods and systems for assessing the motility and function of the gastrointestinal tract in those regions of a patient. It will therefore be convenient to describe the present disclosure in the context of methods and systems for assessing gastrointestinal motility and peritoneal function.

[0002] The method and system of the present disclosure are particularly suitable for use in patients who may suffer from gastrointestinal or peritoneal dysfunction.This condition may be quite common in patients who are receiving medications that affect gastrointestinal function, such as GLP-1 receptor agonists (e.g., semaglutide) or analgesics (e.g., opioids), or in patients with serum electrolyte abnormalities, patients recovering after surgery or non-surgical intervention, patients suffering from disease states (e.g., diabetes, ascites), and / or patients undergoing continuous ambulatory peritoneal dialysis.However, it will be understood that the method and system of the present disclosure are not limited to these applications and can also be used to more generally verify function in this area. [Background technology]

[0003] Any reference in this specification to background art, including any documents, is intended solely to facilitate an understanding of the present disclosure and is not to be taken as an acknowledgement that such background art is widely known or forms part of the common general knowledge in the relevant field in Australia or any other country.

[0004] The human abdomen is the area between the rib cage and pelvis. The abdomen contains various structures, most importantly the organs and digestive tract that function together as the digestive system. Dysfunction of the human abdomen, particularly the digestive system, can occur transiently or permanently as a byproduct of various disease states (e.g., diabetes), drug side effects, and / or surgical and non-surgical interventions. A prominent form of gastrointestinal dysfunction is ileus, which is a slow or uncoordinated gastrointestinal motility disorder. 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 through peristalsis, a series of muscular contractions that cause the walls of the digestive tract to undulate. If motility is absent in any part of the gastrointestinal tract, all parts upstream, or "above," that part also cease peristalsis. Parts downstream, or "below," the part with no motility may continue to peristalsize. Lack of motility can be due to medications that alter gastrointestinal function, disease states such as diabetes, serum electrolyte imbalances, obstruction (tumor, adhesions, intussusception), poor blood flow (thromboembolic infarction), inflammation (diverticulitis), infection (appendicitis), or temporary gastrointestinal paralysis after surgery (the so-called "stun" state).

[0005] Current techniques for assessing a patient's stomach, small intestine, and peritoneal function and dysfunction are categorized into patient history, physical examination, observation of vital signs, laboratory tests, and invasive procedures ranging from imaging to exploratory surgery. The history taking typically identifies symptoms the patient may be experiencing, such as abdominal pain, nausea, vomiting, or changes in bowel habits.

[0006] Physical examination typically reveals clinical findings such as abdominal distension, mobile dullness, and auscultation of bowel sounds. Bowel sounds, which are associated with peristalsis, can vary widely in frequency and pitch, even in healthy patients. Postoperative patients have intermittent bowel sounds at best. A commonly recommended approach is for physicians to auscultate the four quadrants of the abdomen with a stethoscope for 10 minutes every hour. However, this approach is usually impractical due to other physician demands and the variability in the timing and location of bowel sounds. Auscultation is often performed for less than optimal times, resulting in patients fasting for extended periods or, sometimes, ingesting food before peristalsis is detected.

[0007] The usefulness of diagnostic techniques varies depending on the clinical situation. Imaging techniques are useful when a pathology is suspected based on history and / or physical examination, particularly in emergency situations. However, bedside imaging techniques suitable for routine use to verify gastrointestinal dysfunction or functional fluctuations have yet to be established. One technique that has been tested in this regard is portable ultrasound. However, its value is often limited, especially considering the confounding effects of intestinal gas and obesity on image acquisition and image quality.

[0008] Automated methods for detecting gastrointestinal sounds have not proven successful because artifact sounds picked up by stethoscopes and microphones are more frequent, louder, and similar to true gastrointestinal sounds. Furthermore, frequent patient movement and tossing can introduce additional artifacts that can obscure or "drown out" true gastrointestinal sounds. A further problem and difficulty with recording sounds on the ward is privacy and confidentiality concerns, and as a result, no ultra-noisy automated detection methods are currently in widespread use. The "gold standard" method for determining gastrointestinal motility is scintigraphy using a radioactive tracer and a gamma camera. While primarily used in research settings, these methods are largely unsuitable for postoperative clinical practice due to their resource requirements, the use of radioactive materials, and the requirement that patients swallow the tracer before gastrointestinal function has been established.

[0009] Some researchers have proposed methods for assessing gastrointestinal motility that require patients to ingest substantial volumes (e.g., hundreds of mL) of high-salt "contrast" media to assess gastric emptying. This requires the patient to ingest large amounts of salty fluid, making it unsuitable for postoperative patients, especially in the early postoperative period when recovery of gastrointestinal function has not yet been confirmed. Furthermore, the contrast media's strong salty taste makes it difficult for patients to swallow, reducing the attractiveness of this approach. This approach increases the risk of nausea and vomiting, particularly in patient populations already at high risk (i.e., those undergoing surgery). Aspiration pneumonia is a significant cause of morbidity and mortality after general surgery, and the risk is increased by vomiting.

[0010] Other researchers have recently described auscultatory techniques for detecting gastrointestinal motility and irritable bowel syndrome using piezoelectric transducers as microphones or acoustic energy sensors through signal processing. This research has been underway for some time, as exemplified in U.S. Patent Application Publication No. 2008 / 0253535, but is not yet mature enough for commercial use.

[0011] Following the rapid development of electrocardiography (ECG), several attempts have been made to employ transcutaneous electrogastrography (EGG) as a noninvasive technique for detecting and recording 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. One example is described in U.S. Patent Application Publication No. 2018 / 0317800. Importantly, it remains to be determined which myoelectric variables can be reliably recorded by EGG or how EGG correlates with gastric motility and emptying.

[0012] In another study, U.S. Patent Application Publication No. 2020 / 0253535 describes a system for monitoring colonic motility with electrode pairs placed on each of the posterior (buttock) portions of a subject's pelvic region. Importantly, the system is not suitable for detecting or assessing a patient's gastrointestinal motility in the stomach and / or pylorus region.

[0013] It would be desirable to provide new methods and systems for assessing the health of a patient's abdominal cavity or gastrointestinal tract, particularly gastrointestinal motility. More particularly, it would be desirable to provide methods and systems for assessing gastric, small intestinal, or peritoneal function and dysfunction, particularly gastrointestinal motility or functional changes in those areas of a patient. In this context, it would be desirable to provide methods and systems that can assess peristalsis in the stomach and / or pylorus without relying on sound analysis. Summary of the Invention

[0014] According to one aspect, the present disclosure provides a method for assessing intraperitoneal health, particularly gastric, small intestinal, or peritoneal function or dysfunction, particularly gastrointestinal motility or functional changes in said regions, comprising: placing at least two electrodes on the patient's abdomen, preferably on both sides of the abdomen (e.g., anterior / ventral and posterior / dorsal); applying current signals to a plurality of electrodes to deliver current to the abdomen; determining or measuring the electrical conductivity of the abdomen along a current path between the plurality of electrodes; verifying the change in abdominal conductivity determined or measured over a period of time, wherein the change in abdominal conductivity over the period of time provides an indication of intra-abdominal or gastrointestinal function, particularly stomach, small intestine, or peritoneal function; The present invention provides a method comprising:

[0015] 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 a current path through the abdomen. For ease of explanation, the at least one electrode for supplying current to the abdomen will be referred to as a "drive electrode," and the at least one electrode for receiving current along a current path through the abdomen will be referred to as a "sense electrode." It will be understood that the drive electrode and the sense electrode may be essentially the same. Furthermore, when connected in a circuit with an alternating current (AC) source, the designation of a "drive" electrode or a "sense" electrode in the disclosed methods or systems is purely conceptual in the sense that which electrode of a pair is operating as the "drive" electrode or the "sense" electrode may simply change over time (i.e., alternate).

[0016] In one embodiment, the step of placing multiple electrodes on the patient's abdomen, preferably on both sides of the abdomen, is adapted to maximize current flow through the gastrointestinal tract. This step may include placing multiple electrodes on the patient's stomach, pyloric antrum, duodenum, and / or areas at the level of the patient's kidneys. In the context of the present disclosure, those skilled in the art will understand that the stomach's exit (i.e., the pylorus) has a well-defined anatomical location (i.e., the transpyloric plane). This differs from other parts of the gastrointestinal tract, which are more mobile. Furthermore, because the pylorus is located at the top of the gastrointestinal tract, if an obstruction occurs anywhere in the gastrointestinal tract, the pylorus will stop the passage of contents into the duodenum. Therefore, the present disclosure can utilize this location to monitor gastrointestinal motility. If peristalsis occurs at the level of the pylorus, it can be inferred that there are no problems with downstream gastrointestinal motility.

[0017] Thus, for example, multiple electrodes can be positioned to measure conductivity across the stomach and / or duodenum at the pyloric sphincter. It should be noted that conductivity measurements typically vary from individual to individual, depending on the individual's physiology as well as the food and liquid intake. Therefore, the disclosed systems and methods involve monitoring an individual over a period of time to track changes in that individual's conductivity measurements, rather than a specific absolute value measured or determined. Changes in conductivity measured or determined by multiple electrodes can be attributed to fluid movement within the body. If a change is detected across the pyloric sphincter, it can be inferred that the change occurs as a result of fluid movement across the pyloric sphincter. This may therefore be indicative of peristalsis and may be flagged for review by a medical professional.

[0018] In one embodiment, applying a current signal, preferably an alternating current signal, to the plurality of electrodes comprises applying the signal intermittently or intermittently over a period of time, and determining or measuring the electrical conductivity of the abdomen along the current path between the plurality of electrodes comprises determining or measuring the electrical conductivity periodically over the period of time, wherein determining or measuring the electrical conductivity is performed via a meter or sensor as the signal is applied to the plurality of electrodes.

[0019] In one embodiment of the present disclosure, the step of placing a plurality of electrodes on the patient's abdomen, preferably on both sides of the abdomen, includes placing one electrode on a first side (e.g., posterior or dorsal) of the abdomen and at least two other electrodes on a second side (e.g., anterior or ventral) of the abdomen, preferably spaced apart from one another by a distance ranging from about 100 mm to about 500 mm. In this case, each of the plurality of anterior electrodes typically receives current from the posterior electrode along partially divergent or separate current paths through the abdomen. Preferably, the step of determining or measuring conductivity is performed sequentially (e.g., via a meter or sensor) between the posterior electrode and each anterior electrode. That is, electrode pairs (i.e., the posterior electrode and each anterior electrode) are sequentially interrogated to determine or measure conductivity along the separate current paths.

[0020] In one embodiment of the present disclosure, the step of placing a plurality of electrodes on the patient's abdomen, preferably on both sides of the abdomen, includes placing at least two (drive) electrodes on a first side (e.g., the posterior or dorsal side of the abdomen) of the patient, preferably spaced apart from one another by about 100 mm to about 500 mm, and placing at least two (sense) electrodes on a second side (e.g., the anterior or ventral side) of the abdomen, preferably spaced apart from one another by about 100 mm to about 500 mm, where each electrode pair (e.g., each posterior electrode paired with each anterior electrode) is adapted to measure conductivity along a separate or at least partially separate current path through the abdomen.

[0021] In a previous study, one researcher (Sutton) used Kelvin (four-terminal) impedance measurements to obtain gastric impedance across a single, discrete current pathway. The present disclosure involves measuring or determining the (reciprocal) conductivity and employs multiple multi-terminal measurements (e.g., two, three, or four) instead of a single four-terminal measurement. The anatomical locations of interest in the present disclosure are also different from those investigated by Sutton. Furthermore, the presently disclosed method and system does not rely on the use of contrast media (e.g., low-conductivity contrast media) that patients were required to ingest for Sutton's study, which, as noted above, is often medically discouraged for postoperative patients. The presently disclosed system and method does not require patients to ingest contrast media for the study. Instead, the presently disclosed method and system assesses gastrointestinal motility and / or intra-abdominal function based on the temporal difference in signals between different conductive pathways. In particular, the method and system employ different patterns, namely (1) signal differences at the same time between different conductive pathways, and (2) changes in conductivity along each conductive pathway over time, to assess function or changes in function (or conversely, negate dysfunction) of the stomach, small intestine, or peritoneum.

[0022] In one embodiment of the present disclosure, the step of applying the current signals includes applying the current signals intermittently or intermittently to each electrode sequentially, with a time lag between each other of a short period of time, e.g., less than 1 second, preferably in the range of 10 ms to 500 ms. In this manner, current from one (drive) electrode is received separately and sequentially by each of two other (sense) electrodes in the pair along each of two current paths, and the conductivity of each of those current paths is determined or measured. Current from the other electrode is then similarly received and transmitted sequentially or with a time lag between each of two other (sense) electrodes along two further current paths, and the conductivity of each of those current paths is similarly determined or measured.

[0023] Thus, in an embodiment of the present disclosure, the step of determining or measuring abdominal conductivity includes determining or measuring the conductivity between each electrode pair (e.g., including a "drive" electrode and a "sense" electrode) periodically over a period of time. The "dwell" period (i.e., the time or period during which current is transmitted) of each current path between each electrode pair is preferably relatively short, for example, in the range of about 1 to 10 cycles of the AC frequency. For AC supplied at 50 Hz, the "dwell" period preferably ranges from about 20 ms to 200 ms. Preferably, each electrode pair is energized or has a current signal applied to it in a predetermined sequence. The entire sequence or "loop" through the electrode pairs is preferably repeated without a break.

[0024] In one embodiment of the present disclosure, the step of providing a signal includes providing an AC signal. However, it will be appreciated that the methods and systems of the present disclosure are not limited to the use of AC signals, and other signal formats may be used. For example, a range of DC signals and / or regulated signal formats are feasible.

[0025] In one embodiment, the step of applying the current signals includes applying both low frequency and high frequency alternating signals to or between the electrodes to determine or measure both 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.

[0026] In one embodiment of the present disclosure, the step of determining or measuring abdominal conductivity includes determining or measuring conductivity for both low-frequency and high-frequency alternating current signals along the current path(s), and the overall abdominal conductivity along the current path(s) is based on the conductivity measurements for both the low-frequency and high-frequency signals. In this manner, the determination or measurement of conductivity along the current path(s) is performed using a dual-frequency method with low-frequency and high-frequency alternating current signals. By using both low-frequency and high-frequency alternating current signals, the difference in conductivity at the two frequencies can be used to evaluate gastrointestinal motility, the presence or absence of gastrointestinal wall swelling, or changes in the characteristics of ascites or 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 moving by peristalsis across the same region between the two electrodes.

[0027] In one embodiment of the present disclosure, the step of applying an alternating current signal to at least one pair of electrodes comprises applying a low frequency alternating current signal to the at least one pair of electrodes, the low frequency alternating current signal being less than about 5 kHz, preferably in the range of about 200 Hz to about 2 kHz. Thus, the step of applying a dual frequency alternating current signal to each pair of electrodes comprises a low frequency alternating current signal being less than about 5 kHz, preferably in the range of about 200 Hz to about 2 kHz.

[0028] In one embodiment of the present disclosure, applying an alternating current signal to at least one pair of electrodes comprises applying a high frequency alternating current signal to the at least one pair of electrodes in a range of greater than about 5 kHz, preferably from about 5 kHz to about 50 kHz, and more preferably about 20 kHz. Thus, applying a dual frequency alternating current signal to each pair of electrodes comprises a high frequency alternating current signal greater than about 5 kHz, preferably from about 5 kHz to about 50 kHz, and more preferably about 20 kHz. This high frequency range provides the ability to assess extracellular fluid levels.

[0029] In one embodiment of the present disclosure, the step of determining or measuring abdominal conductivity 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.

[0030] In one embodiment of the present disclosure, the step of providing an alternating current signal includes providing a current signal of approximately 10 mA or less to at least one drive electrode. Currents of up to 10 mA may be acceptable at relatively high signal frequencies, such as above 10 kHz. On the other hand, at lower signal frequencies, e.g., up to approximately 800 Hz, the current may be significantly lower, preferably approximately 100 μA or less. It should be noted that at higher frequencies (e.g., above 1 kHz), large currents may be used without stimulating the neuromuscular junction near the electrode, potentially causing irritation or discomfort to the patient. Therefore, lower currents are generally preferred, but there is a trade-off between accurate measurement of conductivity (which typically requires higher currents) and avoiding stimulation (which typically requires lower currents). The IEC 60601-1 standard for medical electrical equipment provides guidance regarding appropriate currents and frequencies that are safe for patient use.

[0031] In his previous work, Sutton used a single excitation frequency (100 kHz) for impedance measurements. In contrast, the disclosed method and system preferably employs a dual-frequency approach using both low- and high-frequency signals to measure conductivity. This allows for previously unmeasurable measurements of extracellular fluid levels and provides a reference measurement for comparing conductivity along each current path. Sutton's previous work used a continuous excitation current of 4 mA at 100 kHz. In contrast, the present disclosure uses both low- and high-frequency pulsed currents designed to avoid neuromuscular stimulation, within regulatory limits.

[0032] In one embodiment, the disclosed method includes features and uses techniques to address three major sources of abdominal conductivity artifacts: (i) breathing (or speaking or coughing), (ii) gross body movement (e.g., sitting up, rolling over, etc.), and (iii) heartbeat (i.e., measurable conductivity changes due to aortic pulsation). Heartbeat can be captured by detecting the heart rate from the ECG signal. This is typically on the order of 1 Hz to 3 Hz and can be functionally removed by determining or measuring abdominal conductivity across the electrodes and averaging at 0.3 Hz. Gross body movement can be detected using a triaxial accelerometer placed on the patient (e.g., at the electrode location). If the accelerometer readings indicate movement above a threshold (e.g., ±0.1 g of ambient resting levels), conductivity measurements may be ignored until the accelerometer readings return to ambient or "normal" levels at rest. Respiratory artifacts are more difficult to explain, isolate, or capture. Because respiration is a large signal with a period of approximately 2 to 5 seconds, a boxcar detector can be used to synchronize with respiration and invert its changes. This largely eliminates its effects, but variations in the respiratory cycle and speech can still be anomalies. During speech, the patient's diaphragm moves irregularly, causing occasional abrupt changes in conductivity (e.g., at the end of a sentence or during pauses), while gentle diaphragmatic movements result in little change in conductivity. We believe that such artifacts can be resolved using a technique similar to that for gross body movement: a voice detector that can indicate when conductivity measurements should be ignored.

[0033] According to another aspect, the present disclosure provides a system for assessing or verifying the function, altered function, or dysfunction of a patient's small intestine, stomach, and peritoneum, particularly a system for assessing or verifying gastrointestinal motility. The system includes at least one pair of electrodes adapted for placement on the patient's abdomen, preferably on either side of the abdomen, to supply and receive electrical current along a current path through the abdomen; a current source for supplying a current signal to at least one electrode of the pair of electrodes; a meter or sensor for determining or measuring abdominal conductivity along the current path between the plurality of electrodes; and a processor for analyzing and / or verifying the abdominal conductivity determined or measured by the meter or sensor over a predetermined period of time to provide an assessment of gastrointestinal health, particularly to detect altered function of the stomach, small intestine, or peritoneum. To this end, changes in abdominal conductivity in a region of the stomach, small intestine, or peritoneum over a predetermined period of time can provide an indication of gastrointestinal motility and / or function within that region.

[0034] According to yet another aspect, the present disclosure provides an apparatus for use in detecting gastric, small intestinal, or peritoneal function / dysfunction, particularly gastrointestinal motility, in a patient, the apparatus comprising: a current source adapted to supply or apply a current signal to or between at least a pair of electrodes adapted for placement on the abdomen of the patient; a meter or sensor for determining or measuring the electrical conductivity of the abdomen along the current path between the electrodes; a processor for analyzing abdominal conductivity determined or measured by the meter or sensor over a predetermined period of time to provide an assessment of gastrointestinal motility or dysfunction; Equipped with.

[0035] In one embodiment of the present disclosure, the current source is adapted to supply or apply an alternating current signal to or between a pair of electrodes. However, it will 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 various regulated signal forms are possible. At least one of the electrodes typically supplies current to the abdomen, and at least one of the electrodes receives current along a current path through the abdomen.

[0036] In one embodiment of the present disclosure, the system or device includes a memory, particularly a digital memory or storage device, for recording or storing the determined or measured abdominal conductivity along the current path(s) between at least one pair of electrodes over a period of time. In this manner, the memory can store a history of the system's use for one or more patients. The memory can comprise, for example, a random access memory of a processor or a storage device such as a flash drive. The system or device is preferably connectable, for example, physically, directly, or wirelessly, to a display or printer for displaying or printing the results of the assessment or verification of gastric, small intestinal, or peritoneal function, functional changes, or dysfunction, particularly the recorded gastrointestinal motility, for one or more patients.

[0037] In one embodiment of the present disclosure, the systems and devices may be adapted to communicate and / or interact with one or more remote or mobile devices. In this regard, the systems and / or devices of the present disclosure preferably include a software application to support remote access to the system's or device's analyses and measurements by one or more individuals. For example, the software application may be accessible or operable via a mobile telecommunications device ("mobile device"), such as a smartphone or tablet. In this manner, the system's analyses and / or measurements from one or more patients may be made available or communicated to a medical professional located remotely from the patient(s).

[0038] In one embodiment of the present disclosure, the current source is adapted to supply a low frequency AC signal, preferably less than about 5 kHz, more preferably in the range of about 200 Hz to 2 kHz, to the at least one drive electrode, The low frequency AC signal is preferably supplied in a dual frequency manner.

[0039] In one embodiment, the current source is adapted to supply a high frequency alternating current signal to the 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 supplied in a dual frequency manner.

[0040] In one embodiment of the present disclosure, the meter or sensor is adapted to determine or measure the electrical conductivity of the abdomen along the current path between the electrodes for both low-frequency and high-frequency AC signals, e.g., in dual-frequency operation. In this manner, the "normal" or overall electrical conductivity of the abdomen along the current path may be based on the electrical conductivity measurements for both the low-frequency and high-frequency signals. Preferably, the current source is adapted to supply an AC signal to at least one pair of electrodes with a current of about 10 mA or less for high-frequency AC signals and about 100 μA or less for low-frequency AC signals, as described above with reference to the IEC 60601-1 standard.

[0041] In one embodiment, the sensor is adapted to determine or measure abdominal electrical conductivity between at least one pair of electrodes multiple times per second, preferably at least five times per second. To this end, the sensor preferably acquires or samples from the electrodes at a frequency ranging from five to thirty times per second. By sampling or acquiring the electrodes multiple times per second to measure electrical conductivity, it is possible to eliminate the influence of other biological motions or signals, such as cardiac signals, from the measurements. In this regard, samples taken at a rate of five times per second allow for electrocardiographic signals to be addressed, while sampling at a higher rate, such as 10 or 20 times per second, better addresses electrocardiographic signals. Other human biological signals generally have lower frequencies, e.g., breathing at approximately 0.2 Hz.

[0042] In one embodiment, the at least one pair of electrodes comprises at least four electrodes, including at least two electrodes adapted to be spaced apart from one another on a first side (e.g., posterior or dorsal) of the abdomen and at least two electrodes adapted to be spaced apart from one another on a second, opposite side (e.g., anterior or ventral) of the abdomen. Each of the sense electrodes receives current from each of the drive electrodes along a partially separate or distinct current path through the abdomen. Preferably, the current source is adapted to provide an alternating current signal to each of the drive electrodes intermittently or intermittently in a time-staggered manner, i.e., sequentially. A meter or sensor preferably periodically determines or measures the conductivity of the abdomen along each of the current paths between the electrodes.

[0043] As mentioned above, the electrodes are adapted to be applied to either side of the patient's abdomen in the stomach, pyloric antrum, duodenal region, and / or at kidney level.

[0044] In one embodiment, the disclosed method and system measures multiple separate current paths in a "round robin" fashion. Complete measurements of multiple paths are taken several times per second. This includes multiple low frequency conductivity measurements, multiple high frequency conductivity measurements, and preferably also a reference measurement of a local fixed (non-varying) internal resistance to verify correct functioning of the system.

[0045] According to a further aspect, the present disclosure provides a system for assessing or verifying gastrointestinal health, particularly stomach, small intestine, or peritoneal function, altered function, or dysfunction, particularly an electrode designed for use in a system for assessing a patient's gastrointestinal motility. The electrode comprises at least one pair of electrodes adapted for application to a patient's abdomen, preferably on both sides of the abdomen, with at least one electrode configured to deliver current to the abdomen (e.g., as a drive electrode) and at least one electrode configured to receive current along a current path through the abdomen (e.g., as a sense electrode). The electrodes are designed to be connected to a current source for providing a current signal to the electrodes and to a meter or sensor for determining or measuring abdominal conductivity along the current path between the electrodes. As described above, the output conductivity determined or measured between the electrodes is analyzed or verified over a predetermined period of time to assess gastrointestinal health, particularly potential dysfunction in the stomach, small intestine, or peritoneal region. To this end, changes 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 peritoneal membrane, particularly gastrointestinal motility disorders within this region.

[0046] Electrodes of an electrode pair are particularly suited to the systems and methods of the present disclosure. To this end, calibration of a meter or sensor for determining or measuring abdominal conductivity along a current path between the electrodes, and calibration of a processor for analyzing and / or verifying abdominal conductivity determined or measured by the meter or sensor over a predetermined period of time to assess gastrointestinal motility, particularly to detect function or dysfunction in the stomach, small intestine, or peritoneum, would typically be highly sensitive to electrode variations. For this reason, the electrodes of the systems and methods of the present disclosure are standardized to minimize sources of variation that may confound the resulting measurements or test results. For example, the type of electrode, its structure, size, shape, and interaction with the patient's skin (e.g., via a conductive gel pad) are expected to be important to the reliable functionality of the systems and methods. For this reason, standardization of the electrodes is desirable. It will be appreciated that the design features of electrodes for conductive application to the human body, particularly human skin, are well established, given the various medical uses of such electrodes. An example in this regard is an electrode for an electrocardiogram (ECG). In this particular case, the electrodes are not for passing electrical current through the body but for receiving or detecting electrical activity of the heart, but the characteristic of a conductive connection to the skin is nevertheless relevant.

[0047] In one embodiment, the electrodes may be serialized or coded for compatibility with the processor and / or for compatibility with the system's meters or sensors. In this manner, the disclosed system can be adapted to work only with electrodes that are "recognized" by and compatible with the system, i.e., electrodes for which the system was designed and calibrated, thereby minimizing sources of variation and error in patient measurements and test results. All electrodes may be substantially identical in structure.

[0048] According to a further aspect, the present disclosure provides a method for assessing or verifying intraperitoneal health, particularly stomach, small intestine, or peritoneal function, altered function, or dysfunction, particularly gastrointestinal motility, of a patient, comprising: storing electronic program instructions for controlling the controller; controlling the controller via electronic program instructions to perform the following operations: providing or applying a current signal to or between at least a pair of electrodes attached to the patient's abdomen, wherein at least one of the plurality of electrodes provides the current to the abdomen and at least one of the plurality of electrodes receives the current along a current path through the abdomen; determining or measuring the electrical conductivity of the abdomen along the current path between the electrodes, for example via a meter or sensor; analyzing the determined or measured abdominal conductivity over a period of time to provide an assessment of intra-abdominal health; A method comprising:

[0049] According to yet another aspect, there is provided a computer-readable storage medium having stored thereon instructions that, when executed by a computing means, cause the computing means to perform a method according to an aspect of the present disclosure as previously described herein.

[0050] According to a further aspect, the present disclosure provides computing means programmed to perform the methods according to the aspects of the present disclosure described herein above. [Brief explanation of the drawings]

[0051] For a more complete understanding of the present disclosure and its advantages, exemplary embodiments will be described in more detail in the following description with reference to the accompanying drawings, in which like reference numerals refer to like parts and in which: [Figure 1] 1 is a cross-sectional image of a patient's abdomen or digestive tract showing an anatomical structure of interest. [Figure 2] A schematic electrical model of the body that shows the two main parts or components (i.e., extracellular and intracellular) in a given region of the body as a simple parallel circuit. [Figure 3]FIG. 1 is a schematic diagram illustrating a system for assessing gastrointestinal motility in a patient in accordance with an embodiment of the present disclosure; [Figure 4] FIG. 1 is a diagram illustrating a schematic of components of a system for assessing gastrointestinal motility in a patient according to an embodiment of the present disclosure. [Figure 5] 1 is a flow chart that schematically illustrates a method according to any embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0052] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate certain embodiments and, together with the description, serve to explain the principles of the present disclosure. Other embodiments and many of the attendant advantages will be readily appreciated as the same become better understood by reference to the following detailed description.

[0053] It will be understood that common and / or well-known elements that may be useful or necessary in commercially feasible embodiments have not necessarily been shown in the drawings to facilitate a more abstract view of the embodiments. Elements in the drawings are not necessarily drawn to scale relative to each other. Also, although certain acts and / or steps in method embodiments are described or illustrated in a particular order of occurrence, those skilled in the art will understand that strict adherence to that order is not actually required.

[0054] Referring first to FIG. 1, the abdomen or digestive tract A of a patient's body B is shown in cross section. Within the abdomen A, there are several locations where the anatomical structures associated with the digestive tract are relatively fixed. These include the pylorus Y of the stomach C and the duodenum. Most other portions of the digestive tract are somewhat mobile within the abdomen A. The cross-sectional image of the digestive tract A in FIG. 1 shows the anatomical structures of interest and the pancreas F. This cross-section was taken at the level of the kidneys K (i.e., the region from thoracic vertebra T12 to lumbar vertebra L2) and is shown looking up from the feet toward the head, with the patient's right side on the left side of the image and the spine S at the bottom of the image. A fluid level L is visible in the stomach C, suggesting that the patient is in a supine position, i.e., lying face up.

[0055] The flow of electric current through the body is governed by the conductivity of structures and materials along the current path. The most conductive materials in the human body are typically extracellular fluids, such as urine, lymph, and blood, because they are mostly aqueous solutions containing primarily salts. The next most conductive materials are typically muscle and vascular organs, such as the liver and kidneys. Bone, fat, and skin have the lowest conductivity. From a conductivity perspective, there are two main parts of human tissue: the intracellular matrix and the extracellular matrix. The extracellular matrix / fluid includes stomach and intestinal contents, blood, and lymphatic fluid within tissues. The cell membrane is a wall-like structure that surrounds cells and retains the intracellular fluid or fluid within the cell. The cell membrane is composed of pore-filled lipids. The lipid layer of the cell membrane has very low conductivity, while the intracellular fluid is a salt-water solution and generally has a much higher conductivity. Therefore, these two parts of tissue (within the same region of the body) can be modeled as a simple parallel circuit, as shown in Figure 2.

[0056] Referring to FIG. 2, the path of an electrical AC signal supplied from an AC power source V through the extracellular matrix can be modeled as a simple resistive circuit with resistance Re. Meanwhile, the path of an electrical AC signal through the intracellular matrix can be modeled as a circuit with a capacitor Ci and a resistor Ri connected in series, where the capacitor Ci represents the cell membrane. This means that low-frequency AC currents (e.g., less than 2 kHz) only pass through the extracellular matrix, resulting in low conductivity, whereas high-frequency AC currents (e.g., greater than 50 kHz) pass partially through the intracellular space, resulting in higher conductivity in the same region. The overall impedance (Z) is shown in FIG. 2 for two AC frequencies. Against this background, the system and method of the present disclosure were developed to employ a dual-frequency approach.

[0057] 3 and 4, a system 1 and associated method according to one embodiment of the present disclosure are described. The system 1 and method are for measuring electrical conductivity between conductively applied electrodes D0, D1, S0, and S1 placed on the skin of the posterior (dorsal) and anterior (ventral) sides of the abdomen A of a patient's body B. The system and method serve as a means of assessing the health and activity of the gastrointestinal tract, more specifically, indirectly assessing gastrointestinal peristalsis and the movement of fluid across the pyloric sphincter or between the pyloric antrum and the duodenum, thereby verifying the function or changes in function of the stomach, small intestine, or peritoneum. As shown in FIG. 3, four electrodes D0, D1, S0, and S1 are applied or placed on the patient's abdomen A, including two drive electrodes D0 and D1 for supplying alternating current placed on the posterior or dorsal side of the patient and two sense electrodes S0 and S1 for receiving the alternating current along a current path through the abdomen placed on the anterior or ventral side of the patient. All electrodes D0, D1, S0, S1 are positioned near the level of the kidneys (ie, the region from thoracic vertebra T12 to lumbar vertebra L2).

[0058] The estimated current paths (labeled "P") are shown schematically in FIG. 3 by oval regions. Similar to FIG. 1, this view of abdomen A is from the patient's feet toward the head. Electrodes D0, D1, S0, and S1 are connected in pairs, with each of the posterior (drive) electrodes D0 and D1 being paired with a respective anterior (sense) electrode S0 and S1. Thus, there are four electrode pairs D0S0, D0S1, D1S0, and D1S1. As shown in FIG. 4, system 1 comprises a device 10 used to detect function or dysfunction of the stomach, small intestine, or peritoneum, particularly gastrointestinal motility in this region of a patient's body B. Device 10 comprises a current source 11 adapted to supply or apply an alternating current signal to or between each pair of electrodes D0, D1, S0, and S1 located on the anterior and posterior sides of abdomen A of the patient's body, and a current path P between each electrode pair. 00 , P 01 , P 10 , P 11 and a meter or sensor 12 for determining or measuring the electrical conductivity of the abdomen A along the electrode pair D0S0, D0S1, S0, S1. When a current is applied between any pair of electrodes D0, D1, S0, S1, the electrodes are also sequentially sampled by the meter or sensor 12. The current signal is supplied from the current source 11 and / or the meter or sensor 12 samples or samples periodically in the range of 5 to 30 times per second. These sampling rates allow the patient's heartbeat signal to be removed from the measurement, and higher sampling rates can more effectively address this issue. Both a low-frequency AC signal of about 200 Hz and a high-frequency AC signal of about 50 kHz are applied intermittently to each electrode pair D0S0, D0S1, D1S0, D1S1 via the current source 11. Each current path P 00 ,P 01 ,P 10 ,P 11 The conductivity of is the high frequency conductivity σ for both high frequency and low frequency current signals. hi and low-frequency conductivity σ lo The offset conductivity σ is measured as offset is the time T set to start evaluating a case. setThe normal or overall conductivity is compared to this baseline for the remainder of the case evaluation.

[0059] Generally speaking, low frequency conductivity σ lo are the current paths P of the electrode pairs indicated by D0S0, D0S1, D1S0, and D1S1. 00 , P 01 , P 10 , P 11 High frequency conductivity σ hi Then, the normal or overall conductivity is calculated for each path, which should be numerically close to zero. Then, the four paths P 00 , P 01 , P 10 , P 11 The change in conductivity between the electrodes is observed over time. σ offset(Tset) = σ hi(Tset) - σ lo(Tset) (Formula 1) σ overall =σ hi -σ lo -σ offset(Tset) (Formula 2)

[0060] The conductivity is expected to change slowly over a period of several tens of seconds (e.g., between 10 and 30 seconds). 01 As the measured or determined conductivity for electrode pair D0S1 increases, it can be expected that the stomach has expelled more fluid into the antrum. 01 If this conductivity measured or determined for increases, indicating fluid in the duodenum, then the path P between the electrode pair D0S0 00 One would expect the measured or determined conductivity to decrease as fluid is forced from the pyloric antrum across the sphincter and into the duodenum.

[0061] Electrode pair D1S1 measures the conductivity across the entire stomach, but in certain cases (i.e., assuming the patient is supine), the presence of gas in the upper stomach will likely result in a lower conductivity than that measured by electrode pair D0S1. However, this low conductivity reading at D1S1 could simply indicate that electrode S1 is becoming dislodged. In such a case, the conductivities measured or determined by each of the two electrode pairs D0S1 and D1S1 will both decrease. However, if the change in conductivity measured or determined by each of electrode pairs D0S0, D0S1, D1S0, and D1S1 is due to fluid movement within body B, a complementary (paradoxical) conductivity change is expected: the conductivity between one electrode pair increases and the conductivity between the other electrode pair decreases. A similar phenomenon should occur with the other electrode pairs D0S0 and D1S0. If the measured or determined conductivity between both of these electrode pairs, D0S0 and D1S0, decreases, electrode failure or a poor connection may be suspected. However, if the conductivity between one electrode pair increases and the conductivity between the other electrode pair decreases, it can be concluded that there has been fluid movement across the pyloric sphincter, which is an indicator or potential indicator of antegrade gastrointestinal transport. Evidence of transport can then be flagged for review by a medical professional, who can examine the records, evaluate the evidence, and confirm or deny it according to their clinical judgment.

[0062] Four separate current paths P 00 , P 01 , P 10 , P 11The conductivity between each of the electrode pairs D0S0, D0S1, D1S0, and D1S1 is measured sequentially and repeatedly in a "round robin" fashion, with one complete measurement for each of the four current paths performed at least every 200 milliseconds. This results in at least five complete measurements per second. This sequence includes four low-frequency conductivity measurements for each electrode pair, four high-frequency conductivity measurements, and two measurements of the local internal fixed or invariant resistance to ensure proper device operation within each 200-msec cycle. As mentioned above, a higher sampling rate can more effectively remove the patient's heartbeat signal from the measurements, and up to 30 complete measurements per second (i.e., one complete measurement for each of the four current paths P00, P01, P10, and P11 every 33 milliseconds) has been attempted.

[0063] Referring to Figure 4, a simplified circuit diagram is shown to illustrate a preferred embodiment of system 1. System 1 has drive electrodes D0, D1 (shown in dashed lines in a position hidden behind or behind the patient's body B) in circuit connection with sense electrodes S0, S1, all of which are connected to a current source 11 via two eight-channel multiplexers 13, 14 for switching between respective electrode pairs D0S0, D0S1, D1S0, D1S1. Two resistors R1, R2 are provided as local internal fixed or invariant resistors for calibration and continuous referencing or cross-checking during use of system 1. The device 10 comprises a current source 11 for supplying an alternating current signal to electrode pairs D0S0, D0S1, D1S0, and D1S1, and a meter or sensor 12 for periodically interrogating the electrode pairs at a rate ranging from 5 to 30 samples per second to measure or determine the conductivity along each of the current paths P00, P01, P10, and P11 of the electrode pairs D0S0, D0S1, D1S0, and D1S1, respectively. The device 10 incorporates a processor 15 (with memory) for recording or storing the conductivity values ​​measured or determined by the meter 12 over a patient monitoring period. The processor 15 is further adapted to analyze the conductivity of the abdomen A determined or measured by the meter or sensor 12 over that period, particularly changes in the conductivity determined or measured along each of the current paths P00, P01, P10, and P11, to assess and / or detect function or changes in function of the stomach, small intestine, or peritoneum.

[0064] Finally, referring to FIG. 5, a flow chart is shown that schematically illustrates steps in a method for assessing or verifying the function, altered function, or dysfunction of a patient's stomach, small intestine, and peritoneum, particularly gastrointestinal motility, in accordance with the embodiment of the present disclosure described above with reference to FIGS. 1-4. In this regard, the first box (i) in FIG. 5 illustrates the step of positioning electrodes (DO, D1, SO, SI) on the patient's abdomen, including at least one electrode (DO, D1) positioned on the posterior side of the abdomen and at least one electrode (SO, S1) positioned on the anterior side of the abdomen for passing or conducting current along a current path (P) through the abdomen. In a specific example, two electrodes (DO, D1) are positioned at a distance from each other on the posterior side of the abdomen, and two electrodes (SO, S1) are positioned at a distance from each other on the anterior side of the abdomen, with all electrodes (DO, D1, SO, S1) positioned at kidney level. The second box (ii) illustrates the step of applying an alternating current signal to at least one electrode (DO, D1), where the current signal is applied to each electrode (DO, D1) intermittently or intermittently, sequentially, or with a time lag. Next, the third box iii shows each current path P between electrode pairs D0S0, D0S1, D1S0, D1S1 formed by at least one rear electrode D0, D1 and at least one front electrode S0, S1. 00 , P 01 , P 10 , P 11 The final box iv in Figure 5 represents the step of verifying changes in abdominal conductivity determined or measured between electrode pairs D0S1, D1S0, and D1S1 over a period of time, whereby changes in abdominal conductivity over a period of time provide an indication of gastric, small intestinal, and peritoneal function or dysfunction, particularly potential changes in the patient's gastrointestinal motility.

[0065] While specific embodiments of the present disclosure have been illustrated and described, those skilled in the art will recognize that various alternative and / or equivalent embodiments exist. It is understood that each example is merely illustrative and is not intended to limit the scope, applicability, or configuration of the example. Rather, the foregoing summary and detailed description are intended to provide those skilled in the art with a convenient road map for implementing at least one exemplary embodiment, and it will be understood that various changes can be made in the function and arrangement of elements described in an exemplary embodiment without departing from the scope defined in the appended claims and their legal equivalents. In general, the present application contemplates any adaptations or variations of the specific embodiments discussed herein.

[0066] The methods or processes outlined herein may be coded as software executable on one or more processors employing any one of a variety of operating systems or platforms. Further, such software may be written using any of a number of suitable programming languages ​​and / or programming or scripting tools, and may be compiled as executable machine code or intermediate code that runs on a framework or virtual machine.

[0067] In this regard, various inventive concepts may be embodied as a computer-readable storage medium (or multiple computer-readable storage media) (e.g., computer memory, one or more fragmentation tools, and / or scripting tools) that may be encoded as computer memory, one or more floppy disks, compact disks, optical disks, magnetic tapes, flash memory, circuitry within a field programmable gate array or other semiconductor device, or other non-transitory or tangible computer storage medium) and may include one or more programs that, when executed on one or more computers or other processors, perform methods that implement the various embodiments of the present invention described above. The computer-readable medium or media may be transportable such that the program or programs stored thereon can be loaded onto one or more different computers or other processors to implement the various aspects of the present invention described above.

[0068] The terms "program" or "software" are used herein in a generic sense to refer to any type of computer code or set of computer-executable instructions that can be employed to program a computer or other processor to implement various aspects of the embodiments as described above. Furthermore, 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 may be distributed in a modular manner among a number of different computers or processors to implement various aspects of the present invention.

[0069] Computer-executable instructions may 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. Typically, the functionality of the program modules may be combined or distributed as desired in various embodiments.

[0070] Additionally, data structures may be stored on computer-readable media in any suitable form. For ease of illustration, data structures may be shown as having fields that are related via location within the data structure. Such relationships may also be achieved by allocating storage for the fields with locations within the computer-readable media that convey the relationship between the fields. However, any suitable mechanism may be used to establish relationships between information within fields of a data structure, including the use of pointers, tags, or other mechanisms that establish relationships between data elements.

[0071] It will also be understood that, unless the context otherwise requires, the terms "comprise," "comprising," "include," "including," "contain," "containing," "have," and "having," as used herein, and variations thereof, are intended to be understood in an inclusive (i.e., non-exclusive) sense. That is, the processes, methods, devices, apparatus, or systems described herein are not limited to the described features, integers, portions, elements, or steps, but may include other features, integers, portions, elements, or steps not expressly recited and / or inherent to such processes, methods, devices, apparatus, or systems. Furthermore, the terms "a" and "an," as used herein, are intended to be understood to mean one or more, unless expressly stated otherwise. Additionally, references to location terms such as "lower" and "upper," as used in the above description, should be taken in the context of the embodiments depicted in the figures and should not be taken as limiting the disclosure to the literal interpretation of such terms, but rather as would be understood by one of ordinary skill in the art in the appropriate context.

Claims

1. 1. A system for verifying or detecting function or changes in function of the small intestine, stomach, or peritoneum of a patient, comprising: at least one pair of electrodes configured to be placed on opposite sides of the patient's abdomen for supplying and receiving electrical current along at least one current path through the abdomen; a current source for supplying or applying a current signal to or between said electrodes; a meter or sensor for determining or measuring the electrical conductivity of the abdomen along the current path between the electrodes; a processor for analyzing the abdominal conductivity determined or measured by the meter or the sensor over a period of time to detect function and changes in function of the stomach, the small intestine, or the peritoneum; A system comprising:

2. the current source is configured to supply both low frequency and high frequency alternating current signals to or between the electrodes in a dual frequency manner, and to measure or determine both 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; The system of claim 1 .

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

4. 4. The system of claim 1, wherein the current source is adapted to supply a high frequency alternating current signal to the electrodes that is greater than about 5 kHz, preferably between about 5 kHz and about 50 kHz.

5. the sensor or meter is adapted to determine or measure the conductivity of the abdomen along the current path between the electrodes in a dual frequency manner for both low frequency and high frequency alternating current signals, and the overall conductivity of the abdomen along the current path is based on the conductivity measurements for both the low frequency and high frequency alternating current signals; A system according to any one of claims 1 to 4.

6. 6. The system of claim 1, wherein the current source is adapted to supply an alternating current signal to at least one pair of electrodes at a current of about 10 mA or less for high frequency signals of 10 kHz or more and / or at a current of 100 μA or less for low frequency signals of less than 2 kHz.

7. 7. The system of claim 1, 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, preferably in the range of 5 to 30 times per second.

8. 8. The system of claim 1, wherein the at least one pair of electrodes comprises four electrodes, including two electrodes adapted to be spaced apart from one another by a distance ranging from about 100 mm to about 500 mm on a first side (e.g., the posterior side) of the abdomen and two electrodes adapted to be spaced apart from one another by a distance ranging from about 100 mm to about 500 mm on an opposing second side (e.g., the anterior side) of the abdomen, wherein each electrode on the second side forms an electrode pair with each electrode on the first side and receives current from each electrode on the first side along a separate current path through the abdomen.

9. 9. The system of claim 8, wherein the current source is adapted to supply alternating current signals to each electrode intermittently or intermittently, sequentially or with a time lag.

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

11. 11. The system of claim 1, wherein the at least one pair of electrodes is adapted to be positioned on either side of the abdomen in the region of the patient's stomach, pyloric antrum, duodenum, and / or kidneys.

12. 12. The system of claim 1, further comprising a triaxial accelerometer positioned on the patient to detect gross body movement and to analyze the measured or determined abdominal conductivity over the predetermined period based on the detected body movement.

13. 1. A method for verifying or detecting function or changes in function of a patient's small intestine, stomach, or peritoneum, particularly gastrointestinal motility in said regions, comprising: placing a plurality of electrodes on either side of the patient's abdomen, particularly in the region of the patient's stomach, antrum, duodenum and / or kidney level, the plurality of electrodes including 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; applying current signals to the plurality of electrodes; determining or measuring the electrical conductivity of the abdomen along the current path between the plurality of electrodes, wherein changes in the measured or determined electrical conductivity of the abdomen over a predetermined period of time provide an indication of function or changes in function of the small intestine, stomach, or peritoneum; A method comprising:

14. 14. The method of claim 13, wherein the step of placing a plurality of electrodes on opposite sides of the patient's abdomen comprises placing two electrodes spaced apart on a first side of the abdomen and two electrodes spaced apart on a second side of the abdomen, each electrode on the second side forming an electrode pair with a respective electrode on the first side and receiving current from each of the electrodes on the first side along a separate current path through the abdomen.

15. The step of applying the current signal comprises applying the current signal to each of the electrodes intermittently, sequentially or with a time lag between each other; and / or 15. The method of claim 14, wherein the step of applying the current signals comprises applying both low frequency and high frequency alternating current signals to or between the electrodes to determine or measure both low frequency conductivity of the abdomen along the current path between the electrodes and high frequency conductivity of the abdomen along the current path between the electrodes.

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

17. 17. The method of claim 13, wherein the step of determining or measuring the electrical conductivity of the abdomen comprises determining or measuring the electrical conductivity along the current path for both a low frequency alternating current signal below about 5 kHz and a high frequency alternating current signal above about 10 kHz in a dual frequency system, and the overall electrical conductivity of the abdomen along the current path is based on the electrical conductivity measurements for both the low frequency alternating current signal and the high frequency alternating current signal.

18. 18. The method of any one of claims 13 to 17, wherein the step of supplying current signals to the plurality of electrodes comprises supplying low frequency alternating current signals to the plurality of electrodes that are less than about 5 kHz, preferably in the range of about 200 Hz to about 2 kHz.

19. 19. The method of any one of claims 13 to 18, wherein the step of supplying the current signals to the plurality of electrodes comprises supplying high frequency alternating current signals to the plurality of electrodes at greater than about 10 kHz, preferably from about 20 kHz to about 50 kHz, more preferably about 50 kHz.

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

21. 21. The method of any one of claims 13 to 20, wherein the step of applying the current signals comprises applying the current signals to the plurality of electrodes at a current of about 10 mA or less, preferably about 100 μA or less.

22. 22. The method of any one of claims 13 to 21, wherein placing the plurality of electrodes on opposite sides of the patient's abdomen comprises placing the plurality of electrodes in the patient's stomach, antrum, duodenum, and / or kidney regions.

23. 1. A method for verifying or detecting function or changes in function of the small intestine, stomach or peritoneum in a patient, particularly a method for assessing gastrointestinal motility in said regions, comprising: placing a plurality of electrodes on opposite sides of the patient's abdomen for supplying and receiving electrical current along at least one current path through the patient's abdomen, particularly through the patient's stomach, antrum, duodenum, and / or kidney regions; applying an alternating current signal to the plurality of electrodes; determining or measuring the electrical conductivity of the abdomen along the current path between the plurality of electrodes; analyzing the changes in the electrical conductivity of the abdomen measured or determined along the current path over a predetermined period of time to provide an indication of function or dysfunction of the small intestine, the stomach, or the peritoneum; A method comprising:

24. 24. The method of claim 23, wherein the step of placing a plurality of electrodes on opposite sides of the patient's abdomen comprises placing two electrodes spaced apart on a first side of the abdomen and two electrodes spaced apart on a second side of the abdomen, each electrode on the second side forming an electrode pair with a respective electrode on the first side and receiving current from each of the electrodes on the first side along a separate current path through the abdomen.

25. The step of applying the current signal includes applying the current signal to each of the plurality of electrodes intermittently, sequentially or with a time lag between each other; and / or 25. The method of claim 24, wherein the step of applying the current signals comprises applying both low frequency and high frequency alternating current signals to or between the electrodes to determine or measure both low frequency conductivity of the abdomen along the current path between the plurality of electrodes and high frequency conductivity of the abdomen along the current path between the plurality of electrodes.

26. 26. The method of any one of claims 23 to 25, wherein determining or measuring the electrical conductivity of the abdomen comprises periodically determining or measuring the electrical conductivity between the plurality of electrodes as electrode pairs over the predetermined period of time, the electrode pairs including one of the electrodes on a first side and one of the electrodes on a second side.

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

28. 1. A method for verifying or detecting function or changes in function of a patient's stomach, small intestine or peritoneum, particularly gastrointestinal motility in said regions, comprising: storing electronic program instructions for controlling the controller; controlling said controller via said electronic program instructions to perform the following operations: supplying or applying a current signal to or between at least a pair of electrodes attached to the patient's abdomen, wherein at least one of the plurality of electrodes supplies the current to the abdomen and at least one of the plurality of electrodes receives the current along a current path through the abdomen; determining or measuring the electrical conductivity of the abdomen along the current path between the electrodes; analyzing the determined or measured abdominal electrical conductivity over a period of time to verify or detect function or changes in function of the stomach, small intestine or peritoneum; A method comprising:

29. 29. The method of claim 28, wherein the act of determining or measuring the electrical conductivity of the abdomen along the current path between the electrodes comprises determining or measuring the electrical conductivity along the current path for both a low frequency alternating signal below about 5 kHz and a high frequency alternating signal above about 10 kHz in a dual frequency system, and wherein the overall electrical conductivity of the abdomen along the current path is based on the electrical conductivity measurements for both the low frequency alternating signal and the high frequency alternating signal.

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

31. A computer readable storage medium having stored thereon instructions which, when executed by a computing means, cause said computing means to perform the method of any one of claims 28 to 30.

32. Computing means programmed to carry out the method of any one of claims 28 to 30.

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