JP2011519663A - Method and system for monitoring gastrointestinal function and physiological characteristics - Google Patents

Abstract

Disclosed are systems and methods for assessing gastrointestinal motility characteristics and preliminarily other physiological characteristics (eg, heart rate). The method and system are effective when employed to obtain one or more signals related to acoustic energy (ie, sound) emanating from the abdominal region of the body and to determine at least one gastrointestinal parameter or event based on the acoustic energy signal. is there. Gastrointestinal parameters include gastrointestinal mixing, gastrointestinal emptying, gastrointestinal contractions, gastrointestinal events and gastrointestinal transit time including gastrointestinal propulsion, or reflux, irritable enteropathy, ulcerative colitis, constipation, diarrhea, strong contraction group upset Includes system malfunctions.
[Selection] Figure 2B

Description

  The present invention relates to a method for non-invasive assessment of gastrointestinal function and physiological properties.

  Advances in the pharmaceutical industry over the past decades have been essential to extend the length and quality of human life. In addition to the new compounds, oral drug formulation and delivery techniques have improved efficacy, while minimizing dosage and reducing side effects. However, the human gastrointestinal tract is not uniform and, due to differences in digestive enzymes, absorption rates, microbiota, and other factors, there are places in the gastrointestinal tract that are desirable to deliver certain drugs to varying degrees. .

  Pharmaceutical companies have made great efforts to deliver targeted drugs. That is, the location and speed of drug delivery within the gastrointestinal (GI) tract. These efforts have resulted in a variety of basic delivery approaches. For example, gel capsules and solid tablets (tablets), film formulations, and the like. Recently, it has become possible to control micro to nano particle sizes. While these advances have proven useful, the gastrointestinal system varies especially between subjects and within subjects. Gastrointestinal motility characteristics, which are key variables, and the resulting gastrointestinal transit time (or digestion time) make it difficult to define desirable targeted drug delivery techniques.

  Gastrointestinal motility characteristics can also have a significant impact on the clinical evaluation of the efficacy of pharmaceutical formulations. In many cases, it actually affects. Certainly, as is well known in the art, the efficacy of a formulation when an orally administered drug formulation, such as a gel capsule containing the drug formulation, exits the gastrointestinal tract before being optimally digested and absorbed. Is greatly reduced. Furthermore, in some cases it has been found that the capsule stays in the upper part of the gastrointestinal tract (ie, the upper fundus) for a long time (eg, more than 5 hours).

  It is also well known that there is a direct relationship between gastrointestinal motility characteristics and gastrointestinal function. Indeed, in many cases, gastrointestinal motility characteristics reflect normal and / or abnormal gastrointestinal function (eg, gastrointestinal obstruction).

  Various methods and systems have been employed to assess gastrointestinal motility characteristics and transit times. A commonly used technique is the gunmachich graph method. However, there are significant disadvantages associated with the Gunma Smograph method.

  Disadvantages associated with the Gamma Machine Chromatography method are that due to problems (and regulations) related to radioactive material handling and equipment handling experience, a limited number of equipment and specialists can use the method. is there. A further disadvantage is that large clinical trials are not realistic.

  Other methods and systems for evaluating gastrointestinal motility characteristics include mechanisms for acquiring and evaluating gastrointestinal sounds. For example, U.S. Pat. No. 5,301,679 describes a variety of diseases involving gastrointestinal tract diseases by capturing human body sounds using a microphone placed on the surface of the human body, or a microphone placed orally or rectally in the gastrointestinal tract. Methods and systems for providing diagnostic information for various diseases are disclosed.

  Other systems employ microphones that detect gastrointestinal sounds within a specific frequency range. Examples of this are described below. Dalle et al., “Computer Analysis In Bowel Sounds”, Computers in Biology and Medicine, Vol. 4 (3-4), pp. 247-254 (February 1975); Sugrue et al., “Computerized Phonoenterology: The Clinical Investigation of the New System”, Journal of Clinical Gastroenterology. 18, no. 2, pp. 139-144 (1994); Povnard et al., "Ou'attende des systems experiments pures diagnostics trosfunctions intestinology Bioscience. Biostr. 45c-48c (1990).

  A significant disadvantage with conventional acoustic techniques and systems is that the range of information that can be obtained from recorded audio is limited. Indeed, few, if any, disclose the relationship between gastrointestinal sounds and gastrointestinal transit times.

  Accordingly, it is desirable to provide a method and system for assessing gastrointestinal motility characteristics and determining gastrointestinal transit time by abdominal auscultation.

  Embodiments of the present invention provide systems and methods for monitoring gastrointestinal function and preliminarily monitoring other physiological parameters such as heart rate and respiratory rate. The systems and methods of the present invention thereby provide a variety of information including gastrointestinal transit time and other physiological parameters.

  According to one aspect of the invention, a system and method for monitoring gastrointestinal function is provided. The system and method can be employed to effectively acquire one or more signals related to acoustic energy emanating from the abdominal region of the body and determine at least one gastrointestinal parameter based on the acoustic energy signal.

  According to one embodiment of the present invention, a system for monitoring a subject's gastrointestinal function is provided. (A) The system comprises at least one sensor that can be placed on or in the subject's body. The sensor is configured to detect acoustic energy and generate at least one acoustic energy signal representative of the acoustic energy. (B) The system also includes a processing unit configured to receive the acoustic energy signal. The processing unit is further configured to process the acoustic energy signal and determine the occurrence of at least one gastrointestinal parameter or event.

  In one embodiment, the gastrointestinal parameters include an event selected from the group consisting of gastrointestinal mixing, gastrointestinal emptying, gastrointestinal contraction, gastrointestinal propulsion, and gastrointestinal transit time.

  In one embodiment, the gastrointestinal parameters include events related to gastrointestinal system upset selected from the group consisting of reflux disease, irritable enteropathy, ulcerative colitis, constipation, diarrhea, strong contraction group upset.

  According to another embodiment of the present invention, a system for monitoring gastrointestinal function and physiological characteristics is provided. (A) The system comprises at least one acoustic energy sensor that can be placed on or within the body region of the subject. The acoustic energy sensor is configured to detect acoustic energy representing gastrointestinal sound generated by the subject and generate an acoustic energy signal representing the acoustic energy. (B) The system also includes at least one physiological sensor that can be placed on or within the body region of the subject. The physiological sensor is configured to detect a physiological characteristic relating to the subject and generate a physiological characteristic signal representative of the physiological characteristic. (C) The system also includes a processing unit configured to receive the acoustic energy signal and the physiological characteristic signal. The processing unit is further configured to process the acoustic energy signal and the physiological characteristic signal to determine the occurrence of at least one gastrointestinal parameter or event as a function of the acoustic signal.

  According to another embodiment of the present invention, a system for monitoring a subject's gastrointestinal function is provided. (A) The system includes at least one acoustic energy sensor that can be placed near the body region of the subject. The acoustic energy sensor is configured to detect acoustic energy generated by the subject and generate at least one acoustic energy signal representing the acoustic energy. (B) The system also includes at least one spatial parameter sensor that can be positioned near the body region of the subject. The spatial parameter sensor is configured to monitor at least one spatial parameter associated with the subject's body and generate at least one spatial parameter signal representative of the spatial parameter. (C) The system also includes a processing unit configured to receive the acoustic energy signal and the spatial parameter signal. The processing unit is further configured to determine the occurrence of at least one gastrointestinal parameter as a function of the acoustic energy signal and the spatial parameter signal.

  In one embodiment, the spatial parameter sensor comprises a motion sensor configured to monitor movement of the subject's body. The spatial parameter includes the movement of the subject's body.

  In one embodiment, the spatial parameter sensor comprises a direction sensor configured to monitor the direction of the subject's body. The spatial parameter includes the direction of the subject's body.

  According to another embodiment of the present invention, a system for monitoring gastrointestinal function and physiological characteristics is provided. (A) The system includes at least one acoustic energy sensor that can be placed near the body region of the subject. The acoustic energy sensor is configured to detect acoustic energy generated by the subject and generate at least one acoustic energy signal representing the acoustic energy. (B) The system also includes at least one spatial parameter sensor that can be positioned near the body region of the subject. The spatial parameter sensor is configured to monitor at least one spatial parameter related to the subject's body and generate at least one spatial parameter signal representative of the spatial parameter. (C) The system also includes at least one physiological sensor that can be placed near the body region of the subject. The physiological sensor is configured to detect a physiological characteristic associated with the subject and generate at least one physiological characteristic signal representative of the physiological characteristic. (D) The system also includes a processing unit configured to receive the acoustic energy signal, the spatial parameter signal, and the physiological characteristic signal. The processing unit is further configured to determine the occurrence of at least one gastrointestinal parameter as a function of the acoustic energy signal and the spatial parameter signal.

  In one embodiment, the spatial parameter sensor comprises a motion sensor configured to monitor movement of the subject's body. The spatial parameter includes the movement of the subject's body.

  In one embodiment, the spatial parameter sensor comprises a direction sensor configured to monitor the direction of the subject's body. The spatial parameter includes the direction of the subject's body.

  According to another embodiment of the invention, a method for determining gastrointestinal parameters for a subject is provided. The method includes: (a) detecting acoustic energy generated by the subject's gastrointestinal system and generating an acoustic energy signal representative of the acoustic energy; (b) detecting at least one spatial parameter for the subject; Generating (c) at least one gastrointestinal parameter as a function of the acoustic energy signal and the spatial parameter signal.

  According to another embodiment of the invention, a method for determining gastrointestinal parameters for a subject is provided. The method includes: (a) detecting acoustic energy generated by the subject's gastrointestinal system and generating an acoustic energy signal representative of the acoustic energy; (b) detecting at least one spatial parameter for the subject; Generating a spatial parameter signal representative of: (c) detecting a physiological characteristic for the subject and generating at least one physiological characteristic signal representative of the physiological characteristic; (d) at least one gastrointestinal parameter for acoustically Determining as a function of the energy signal and the spatial parameter signal.

  According to another embodiment of the present invention, a method for monitoring gastrointestinal function and physiological characteristics of multiple subjects is provided. The method includes: (a) detecting a first acoustic energy generated by the gastrointestinal system of the first subject and generating a first acoustic energy signal relating to the first subject; and (b) a first physiological characteristic relating to the first subject. Detecting, (c) detecting a second physiological characteristic associated with the second subject, and (d) determining at least one gastrointestinal parameter associated with the first subject as a function of the first acoustic energy signal.

  In one embodiment, the second subject includes the first subject's fetus.

1 is a partial view of a human torso showing a typical gastrointestinal tract. FIG. It is a figure of a human abdomen. 1 is a schematic view of an embodiment of a gastrointestinal analysis system according to the present invention. 2B is a schematic diagram of another embodiment of the gastrointestinal analysis system shown in FIG. 2A according to the present invention. FIG. FIG. 2 is a partial view of the human torso shown in FIG. 1. The figure shows the arrangement of a gastrointestinal sound (or acoustic) sensor according to one embodiment of the present invention. It is the schematic of an analyzer. The figure shows an analyzer subsystem or module according to one embodiment of the invention. 4 is a graph showing accumulated motion parameters (AccM) according to the present invention as a function of time. 1 is a partial view of a human torso wearing a system vest according to one embodiment of the present invention. FIG. FIG. 3 is a schematic diagram of a gastrointestinal motility analysis system with an additional physiological sensor according to another embodiment of the present invention. It is a summary of the results of the Gamma scintigraphy obtained while investigating gastrointestinal motility characteristics. FIG. 9 is a graph of gastrointestinal sound signals reflecting gastrointestinal sounds obtained during the gastrointestinal motility test, summarized in FIG. FIG. 9 is a graph of gastrointestinal sound signals reflecting gastrointestinal sounds obtained during the gastrointestinal motility test, summarized in FIG. FIG. 9 is a graph of gastrointestinal sound signals reflecting gastrointestinal sounds obtained during the gastrointestinal motility test, summarized in FIG. FIG. 9 is a graph of gastrointestinal sound signals reflecting gastrointestinal sounds obtained during the gastrointestinal motility test, summarized in FIG. FIG. 9 is a graph of gastrointestinal sound signals reflecting gastrointestinal sounds obtained during the gastrointestinal motility test, summarized in FIG. FIG. 9 is a graph of gastrointestinal sound signals reflecting gastrointestinal sounds obtained during the gastrointestinal motility test, summarized in FIG. FIG. 9 is a graph of gastrointestinal sound signals reflecting gastrointestinal sounds obtained during the gastrointestinal motility test, summarized in FIG.

  Before describing the details of the present invention, it is to be understood that the invention is not limited to the specifically illustrated structures, devices, systems, materials, methods, etc., which may be varied. Accordingly, although a plurality of devices, systems, and methods similar or equivalent to those described herein can be used in the practice of the present invention, embodiments of the devices, systems, and methods according to the present invention are described below. This is explained here.

  It should also be understood that like reference numerals correspond to like parts or elements throughout the drawings shown below.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention relates. Furthermore, all publications, patents and patent applications cited above or below are incorporated herein by reference in their entirety.

  Finally, as used herein and in the claims, the single form ("a" "an" "the" "one") encompasses a plurality of referents unless explicitly stated. Thus, for example, a “sensor” can include two or more sensors. A “gastrointestinal event” may also include two or more similar events.

Definitions The term “pharmaceutical composition” as used herein refers to any compound or composition, or constituent that provides the desired pharmacological and / or physiological effect when administered to a living tissue (human or animal). Means a combination of and includes these. The term thus encompasses biopharmaceuticals (eg, peptides, hormones, nucleic acids, genetic structures, etc.) as well as substances that have been conventionally recognized as active agents, drugs, prodrugs, and bioactive agents.

  The term “medicament” as used herein means and includes a pharmaceutical composition that produces acoustic energy or gastrointestinal sounds (or sounds) from the gastrointestinal tract when orally administered to a human or animal. For example, but not limited to, pharmaceutical compositions having solid tablets (tablets), gel capsules (which may be hard or soft), caplets, and other solid dosage forms.

  The term “consumable” as used herein means any substance or item that, when orally administered to a human or animal, produces acoustic energy or gastrointestinal sounds (or sounds) from the gastrointestinal tract. Include. Thus, an “ingestible” includes, but is not limited to, a drug and a non-drug composition such as a placebo.

  The term “gastrointestinal function” as used herein refers to and includes, but is not limited to, the operation of all organs and structures with respect to the gastrointestinal system.

  The terms “gastrointestinal system upset” and “adverse gastrointestinal system event” as used herein means, but are not limited to, malfunction of the gastrointestinal system. This includes, but is not limited to, malfunctions that interfere with the digestive process, such as gastrointestinal obstruction.

  The term “gastrointestinal event” as used herein means and encompasses activities or functions related to the gastrointestinal system. This includes, but is not limited to, gastrointestinal mixing, gastrointestinal drainage, gastrointestinal contraction, and gastrointestinal propulsion. “Gastrointestinal events” may include events relating to “gastrointestinal system upset” or “harmful gastrointestinal system events”. Examples include, but are not limited to, reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and strong contraction group (MMC) phase disorder.

  The term “gastrointestinal parameters”, as used herein, means and includes properties relating to gastrointestinal function. This includes, but is not limited to, gastrointestinal events and gastrointestinal transit times.

  The term “gastrointestinal sound” as used herein means and encompasses acoustic energy (and all signals contained therein) generated by a gastrointestinal event.

  The term “gastrointestinal transit time” as used herein refers to the time of movement through one or more regions of the gastrointestinal tract. This time can be affected by the composition being passed through, the condition of the gastrointestinal tract, physiological stress, sex, and other factors. “Gastrointestinal transit time” is a general term that can be used to describe total gastrointestinal transit time, basal-rectal transit time, and various other exercise times through one or more regions of the gastrointestinal tract.

  The term “total gastrointestinal transit time”, as used herein, passes multiple areas of the gastrointestinal tract via a planned route (eg, oral, rectal) from the point of administration of the drug or ingestible. It means the exercise time until it is discharged from the body.

  The term “basal-rectal gastrointestinal transit time” as used herein means the exercise time until the drug or ingestible material enters the bottom of the stomach and is excreted from the rectum (see FIGS. 1A and 1B). To do.

  The term “signal voltage limit” as used herein means a limit derived from a plurality of acoustic energy signal voltages. The “signal voltage limit” has an upper boundary and a lower boundary defined by the acoustic energy signal voltage.

  The term “signal amplitude limit” as used herein means a limit derived from a plurality of acoustic energy signal amplitudes. The “signal amplitude limit” has an upper boundary and a lower boundary defined by the acoustic energy signal amplitude.

The term “V _threshold ” as used herein means the minimum voltage whose value is considered significant. According to the present invention, when the signal voltage limit is less than V _threshold , there is no response (ie, the signal is less than the sensitivity of the detector). If the signal voltage limit is greater than V _threshold for a predetermined time or more, the value is considered significant.

  The terms “physiological characteristic” and “physiological parameter” as used herein mean and encompass any characteristic relating to body organ function, excluding life forms (human or animal) and / or gastrointestinal parameters. This includes, but is not limited to, ECG, heart rate, blood pressure, blood gas saturation (eg, oxygen saturation), respiratory rate, skin temperature, and deep body temperature. The term also includes pharmacokinetic (PK) parameters.

  The term “spatial parameter” as used herein refers to the subject's body orientation (eg, whether the subject is supine, lying down, sitting, standing, etc.) and / or body movement (eg, when the subject is stationary). Or any change in body posture, walking, etc.).

  The terms “spatial parameter value” and “spatial parameter coefficient”, as used herein, mean and encompass the numerical value representing a spatial parameter and / or the effect of a “spatial parameter” on a gastrointestinal parameter or event.

  The term “subject” as used herein means and includes a human or animal. The term also includes prenatal humans, ie fetuses and animals.

  The present invention provides systems and methods for monitoring gastrointestinal function and other physiological characteristics of a patient or subject in advance. As described in detail herein, in some embodiments, the method and system according to the present invention obtains one or more signals relating to acoustic energy (ie, sound) emanating from the abdominal region of the subject's body, and (i) Employed to determine at least one gastrointestinal parameter and / or its appearance based on the acoustic energy signal and / or to determine an event and / or its occurrence related to (ii) gastrointestinal system upset (and / or gastrointestinal system upset) It is effective.

  As described in detail herein, some embodiments of the systems and methods according to the present invention are configured to effectively capture spatial parameters associated with a subject, such as the subject's body orientation and / or movement.

  It may be advantageous to employ the method and system according to the present invention to obtain one or more signals relating to physiological parameters or characteristics such as heart rate, respiratory rate, blood pressure, for example.

  The methods and systems according to embodiments of the present invention can perform or complete selected tasks or steps manually or automatically, or a combination thereof, as described herein. In some embodiments of the present invention, the selected steps can be implemented by hardware or software or any operating system or any firmware or combination thereof. For example, with hardware, selected steps according to embodiments of the present invention can be implemented as a chip or a circuit. If software, the selected steps according to embodiments of the present invention can be implemented as a plurality of software instructions that are executed by a computer using any suitable operating system. In any case, selected steps of the method and system according to the present invention can be described as being performed by a data processor such as a computing platform executing multiple instructions.

  As shown in FIG. 1A, a general gastrointestinal tract (denoted by reference numeral 10) is shown in the figure. As shown in FIG. 1, the gastrointestinal tract 10 generally has an esophagus 12, a stomach 13, a small intestine 15, and a large intestine 16. The large intestine has a cecum 17, a colon 18, and a rectum 19.

  As shown in FIG. 1B, the stomach 13 has a basal region (or base) 14a and a pyloric sinus (or gastric sinus) 14b.

  As is well known in the art, gastrointestinal motility characteristics (normal male / female subjects) are generally characterized by the appearance of three distinct phases repeated. These are called the strong contraction group (MMC). Phase 1 includes a period or phase without contraction. Phase 2 follows phase 1 and includes an intermittent, amplitude changing contraction. Phase 3 follows phase 2 and includes a phase of contraction that propagates repeatedly. The strong contraction group has an average period of 80 to 150 minutes.

  It is well known and demonstrated in the art that separate sounds are emitted from the gastrointestinal tract during each of the above phases. For example, see below. Tomomasa et al., “Gastrointestinal Sounds and Migrating Motor Complex in Fasted Humans”, The American Journal of Gastroenterology, Vol. 94, no. 2, pp. 374-381 (1999); Farrar et al., “Gastrointestinal Mobility as Revealed by Study of Aboriginal Sounds”, Gastroenterology, Vol. 29, no. 5, pp. 789-800 (1955); B. Cannon, “Authorization of the Rhythmic Sounds, Produced by the Storm and Testines”, Laboratory of Physiology, VI, pp. 339-353 (1905).

  As indicated above, there are various studies and publications on gastrointestinal sounds, but there is a lack of information on the relationship between gastrointestinal sounds and strong contraction groups. Also, there is very little information regarding the relationship between gastrointestinal sounds and gastrointestinal transit times.

  As shown in FIG. 2A, it shows a schematic diagram of an embodiment of a gastrointestinal analysis system 20 according to the present invention. As shown in FIG. 2A, the system 20 includes a plurality of acoustic energy sensors 22a, 22b, 22c, and at least one analyzer 24. In the embodiment shown in FIG. 2A, the system 20 comprises display means 26.

  According to the present invention, the acoustic energy sensors 22a, 22b, 22c detect vibrations and / or sounds on or near the subject's skin surface, and convert these vibrations and / or sounds into electrical signals. Each transducer is provided independently. Other sensors may include internal sensors such as intraesophageal sensors and intragastric sensors that are introduced into the subject (or patient) using a nasogastric tube or the like.

  By way of example only, acoustic energy sensors 22a, 22b, 22c may be electronic stethoscopes, contact microphones, non-contact vibration sensors, capacitive or optical sensors, or other suitable types of sensors. The acoustic energy sensors 22a, 22b, and 22c are preferably selected to have an acoustic impedance that matches the impedance of the skin surface and optimally acoustically couple to the skin surface, but this is not essential. In addition, because of background noise and relatively low amplitude vibrations or sounds generated at or near the skin surface by gastrointestinal sounds, the acoustic energy sensors 22a, 22b, 22c may have a high signal to noise ratio, high sensitivity, and / or Although it is desirable to select one with high environmental noise covering performance, this is not essential.

  In accordance with the present invention, the acoustic energy sensors 22a, 22b, 22c and the spatial parameter sensors 22d, 22e are low level (ie low power) electrical via the wiring 23 or any suitable medium such as radio frequency, infrared, etc. The signal is transmitted to the analyzer 24.

  A suitable acoustic energy sensor that can be employed within the scope of the present invention is disclosed in US Pat. No. 6,512,830.

  Although two acoustic energy sensors are shown in FIG. 2A, more or fewer sensors can be used to provide multiple locations on the subject's abdomen 11, or gastrointestinal function and / or gastrointestinal motility characteristics (and / or passage). Gastrointestinal sounds can also be detected at any other location of interest on the subject's body that is convenient for assessing time). For example, a single acoustic energy sensor can be placed on the subject's body and / or sequentially moved to different critical locations on the subject's body to detect gastrointestinal sounds.

  As shown in FIG. 2B, another embodiment of the gastrointestinal analysis system 20 is shown. As shown in FIG. 2B, the system 20 similarly includes acoustic energy sensors 22a, 22b, 22c, an analyzer 24, and display means 26. However, in this embodiment, the system 20 further comprises at least one, preferably two spatial parameter sensors 22d, 22e.

  In one embodiment of the invention, the spatial parameter sensor 22d comprises a motion sensor configured to monitor a spatial parameter related to the subject's physical movement and to transmit at least one motion signal representative thereof to the analyzer 24. Examples of the body movement of the subject include whether the subject is in a stationary posture, changing the body posture, or walking.

  In one embodiment of the present invention, the spatial parameter sensor 22e comprises a direction sensor configured to monitor a spatial parameter related to the subject's body direction and send at least one directional signal representative thereof to the analyzer 24. Examples of the body direction of the subject include whether the subject is lying on his back, lying down, sitting, or standing.

  Body movement and body orientation can be determined by a number of conventional techniques and means, as will be readily understood by those having ordinary skill in the art. This includes, but is not limited to, optical encoders, proximity switches and Hall effect switches, laser interferometry, and accelerometers.

  The movement sensor and the direction sensors 22d and 22e may be integrated as a multi-function device so that a person having ordinary skills in the field can easily understand. Thus, in some embodiments of the present invention, the sensors 22d, 22e comprise a multi-function triaxial accelerometer (hereinafter referred to as a motion / direction sensor). Due to the versatility of the 3-axis accelerometer, in some embodiments, only one motion / direction sensor (eg, 2d) can be used to monitor body motion and direction.

  As will be described in detail below, the analyzer 24 includes an amplifier, a filter, a transient protection circuit, and other circuits. The circuit amplifies the signals transmitted by the acoustic energy sensors 22a, 22b, 22c (and preliminary movement / direction sensors 22d, 22e). This attenuates the noise signal and / or reduces the effects of aliasing. In particular, the analyzer 24 comprises a low pass filter having a cutoff frequency of about 1100-1400 Hz. In one embodiment of the present invention, the low pass filter has a cutoff frequency of 1200-1300 Hz.

  Alternatively or additionally, a high pass filter may be incorporated in the analyzer 24. The high pass filter has a cut-off frequency of about 70-90 Hz, for example, and unwanted noise or sound, such as muscle sounds, breathing sounds, heart sounds, gastrointestinal sounds that are not of the stomach, or any other undesirable sound or noise, The signals transmitted by the acoustic energy sensors 22a, 22b, 22c are substantially attenuated or removed before being processed.

  The spectral energy of non-gastrointestinal sounds, most likely disturbed, is in the frequency band of about 20-250 Hz. However, the amplitudes of these disturbed sounds can be reduced for adult subjects and can be significantly reduced in some cases by careful consideration of the location of the acoustic energy sensors 22a, 22b, 22c.

  As shown in FIG. 3, there is shown a preferred arrangement of acoustic energy sensors 22a, 22b, 22c and motion / direction sensors 22d, 22e, according to one embodiment of the present invention. As shown in FIG. 3, the acoustic energy sensor 22a is in the upper left quadrant near the stomach bottom, the acoustic energy sensor 22b is in the lower right quadrant near the cecum, and the acoustic energy sensor 22c is in the lower left quadrant near the small intestine. It is desirable to place them respectively in the vicinity of the descending colon.

  According to the embodiment of the present invention, the acoustic energy sensors 22a, 22b, 22c can be arranged at positions other than those shown in FIG. 3 without departing from the scope and spirit of the present invention. For example, the acoustic energy sensor 22a can be placed on a transverse line that is approximately two-thirds of the distance between the navel and the lowest sternum (the xiphoid process) to the right of the center line. The acoustic energy sensor 22b can be placed over the left lateral arch. The acoustic energy sensor 22c can be placed on a center line that is approximately one-half of the distance between the navel and the pubic joint.

  In the embodiment shown in FIG. 3, the motion / direction sensors 22d, 22e are preferably located near the front of the abdomen, preferably near the center of the chest region.

  According to the present invention, the motion / direction sensors 22d, 22e can be similarly disposed at positions other than those shown in FIG. 3 without departing from the scope of the present invention. Furthermore, as described above, only one motion / direction sensor (eg, 2d) can be used.

  As shown in FIG. 4, according to one embodiment of the present invention, the analyzer 24 is configured to perform the following functions. (I) A recorded acoustic energy (or gastrointestinal sound) signal is received from a sensor (eg, acoustic energy sensors 22a, 22b, 22c) 30. (Ii) Record the acoustic energy signal in the memory medium 32. (Iii) The acoustic energy signal is processed (using the signal processing module 33) to obtain at least one gastrointestinal parameter and / or gastrointestinal event (and / or its occurrence) related thereto, according to an embodiment of the invention. In some embodiments of the invention, the analyzer 24 is further configured to compare the gastrointestinal parameter or event with at least one physiological characteristic or parameter. Examples of physiological parameters include pharmacokinetic (PK) parameters that are provided to a subject by administering a pharmaceutical composition.

  In some embodiments of the present invention, the analyzer 24 is further configured to determine an event related to a gastrointestinal system malfunction (and / or gastrointestinal system malfunction), such as a gastrointestinal system occlusion.

  In another embodiment of the present invention, the analyzer 24 is further configured as follows. (I) The recorded motion signal and direction signal are received from the motion / direction sensors 22d and 22e via the wiring 30. (Ii) record motion signals and / or direction signals in the memory medium 32; (Iii) recorded at least one gastrointestinal parameter and / or gastrointestinal event (and / or occurrence thereof) and / or gastrointestinal system upset (and / or gastrointestinal system upset) recorded acoustic energy, motion signal, and / or Determined as a function of direction signal. In this embodiment, the analyzer 24 has algorithms and / or derived spatial parameter coefficients (details are described below). They efficiently capture spatial parameters reflected in motion and direction signals within derived gastrointestinal parameters, events, and upsets. For example, the spatial signal can be used to adjust the acoustic signal.

  As shown in FIG. 4, the analyzer 24 represents the recorded acoustic energy and / or the subject's physical movements and / or directions and / or physiological parameters (described below) according to further embodiments of the invention, It is configured to provide at least one output signal 39.

  According to the embodiment of the present invention, the signal processing module 33 is configured to perform the following. (I) Filter external effects from signal 34; (Ii) A signal amplitude limit is determined based on the signal 36. (Iii) The dominant frequency of the signal 38 is determined.

  According to the present invention, the filtering step 34 can be implemented by software such as a computer program, or hardware. Thus, in some embodiments of the invention, the analyzer 24 is programmed to filter the acoustic energy signal and extract the frequency band of interest from the signal.

  In one embodiment, the frequency of interest is in the range of about 70-1400 Hz. In another embodiment, the frequency of interest is in the range of about 90-1200 Hz.

  According to the present invention, the filtering step 34 can be performed using various conventional programs within the scope of the present invention.

  In other embodiments of the present invention, the filtering step 34 may be performed by hardware. In one embodiment, the analysis circuit comprises a high pass filter and a low pass filter configured to filter external effects from the signal 34. According to the present invention, various high-pass filters and low-pass filters can be employed within the scope of the present invention. In one embodiment, the high pass filter comprises a balance adjustment 401-tapFIR filter having a Blackman window with a cutoff frequency of 80 Hz. The low-pass filter includes a balanced 400-tap FIR filter having a Blackman window with a cutoff frequency of 1250 Hz.

  In one embodiment, the signal amplitude limit can be determined using a sliding Hilbert transform with a 5 microsecond window. As is well known in the art, the Hilbert transform is commonly used to determine signal limits. See below. Tomomasa et al., “Gastrointestinal Sounds and Migrating Motor Complex in Fasted Humans”, The American Journal of Gastroenterology, Vol. 94, no. 2, pp. 374-381 (1999); Farrar et al., “Gastrointestinal Mobility as Revealed by Study of Aboriginal Sounds”, Gastroenterology, Vol. 29, no. 5, pp. 789-800 (1955); these are incorporated herein by reference.

Applicants have found that the Hilbert transform has a short “jump”, ie flattening the intermittent projections of the acoustic energy, and transforming the bipolar acoustic energy signal into a signal that can be easily analyzed with the simple V _threshold described above. .

According to embodiments of the present invention, the dominant frequency of the acoustic energy signal can be determined by various conventional means as well. In one embodiment, the dominant frequency is determined by separating peaks greater than V _{threshold for a} time longer than 5 μs.

  As mentioned above, an important feature and advantage of embodiments of the present invention is that the gastrointestinal analysis system and method effectively captures spatial parameters, ie, body movements and directions, in determining gastrointestinal parameters, events, and upsets. It is a point that can be.

  As shown in FIG. 5, this figure is a graph showing the accumulated composite operation measurement result (AccM) as a function of time. AccM is the sum of the X and Y axes of the body. As shown in FIG. 5, the acoustic signal from the acoustic sensor (channel 1) captures the tablet drug (indicated by α) exiting the stomach, and the motion / direction signal from the motion / direction sensor (ie, the 3-axis accelerometer) is the subject. Is caught standing upright for food (indicated by β). FIG. 5 further illustrates the shift (ie, increase) of the recorded signal caused by subject movement.

  Thus, in some embodiments of the present invention, analyzer 24 comprises algorithms and / or derived spatial parameter coefficients. These effectively capture the derived gastrointestinal parameters, events, motion signals within the malfunction and spatial parameters reflected in the direction signal.

  As mentioned above, spatial parameters, i.e. body movement and direction, can be determined by a number of conventional means such as optical encoders, proximity switches and Hall effect switches, laser interferometers, multi-axis accelerometers. In some embodiments of the present invention, the output of these digital devices, i.e. motion signals and / or direction signals, can be converted into spatial parameter values or coefficients.

  Next, a subject sequence is generated and stored in the memory medium 32. This arrangement includes a plurality of body positions and movements and corresponds to spatial parameter coefficients.

As shown in Table 1, the table shows examples of subject sequences. As shown in Table 1, if the subject is standing and standing still, the maximum value or the spatial parameter is “011”. These are reflected in the output of the XYZ axes.

The spatial parameter coefficient can be used to adjust the recorded acoustic signal. For example, V _threshold can be adjusted for each acoustic energy sensor (eg, 22a, 22b, 22c) based on the predicted gastrointestinal motion at that location.

  As an example of space, when the spatial coefficient is 1 (0 1-1, that is, standing), the acoustic signals of the acoustic energy sensors 22b and 22c (see FIG. 6) are determined when determining the gastrointestinal motion. It can be emphasized more strongly. This is because these sensors are closer to the internal source of the acoustic signal.

  Another example is for determining the direction during sleep. This is said to be related to gastric emptying. When the spatial parameter coefficient is (100) during sleep, the stomach contents are accumulated in the pylorus, so that stronger gastric emptying is expected. In this example, the acoustic signals of the acoustic energy sensors 22a and 22c (see FIG. 6) can be emphasized more strongly.

  2A and 2B, according to the present invention, the display means 26 displays the recorded acoustic energy signal (both before and after processing) and / or body movement and / or body orientation and / or recorded physiological characteristics. Any suitable medium may be provided that provides at least one visual representation to represent. In one embodiment, the display means 26 comprises a computer monitor.

  According to another embodiment of the invention, the display means 26 comprises an audible display. The audible display can be configured to provide sounds or tones representing, for example, body movements, gastrointestinal events, MMC phases. The audible display can be further configured to provide multiple sounds or tones representing physical movement or selectable gastrointestinal events or gastrointestinal system upsets or MMC phases or characteristics related thereto, such as phase initialization.

  The display means 26 comprises a recorded acoustic energy signal (both before and after processing) and / or body movement and / or body orientation and / or recorded physiological characteristics, and body movement or at least one gastrointestinal tract. It is also possible to provide at least one audible sound or tone that represents an event or a physiological characteristic.

  The display means 26 may be an integrated component or function of the analyzer 24, as will be appreciated by those having ordinary skill in the art.

  As those skilled in the art will appreciate, the acoustic energy sensors 22a, 22b, 22c, motion sensor 22d, direction sensor 22e (or multifunctional motion / direction sensors 22d, 22e) according to the present invention are various. It can be placed on the subject's body using conventional means. For example, the sensors 22a, 22b, 22c, 22d, and 22e can include an adhesive ring or an adhesive surface on the housing. This can be configured to temporarily connect to the skin of the subject. The sensors 22a, 22b, 22c, 22d, 22e can also be attached to the subject's skin with medical tape or elastic bandages.

  As shown in FIG. 6, in one embodiment of the present invention, the acoustic energy sensors 22a, 22b, 22c, and the motion / direction sensor 22d are in a substantially fixed position with respect to the subject's body via the vest 40. Can be placed and held. According to the present invention, the vest 40 can include various sizes and materials.

  In one embodiment, the vest 40 is adjustable and includes a lightweight, mesh-like material, such as nylon or lycra. In one embodiment of the invention, the vest 40 includes at least one pocket configured to receive and hold at least one sensor. Desirably, the vest 40 includes a plurality of pockets configured to receive and hold a plurality of sensors. The pocket is arranged at a location corresponding to a selectable position on the subject's body when the subject wears a vest.

  In other embodiments, the vest 40 and sensor comprise a simple relief snap system. In one embodiment, the vest 40 includes a plurality of recesses in the snap system and the sensor includes a protrusion. The convex portion is connected and fixed to the vest 40 when the concave portion accepts the convex portion. In other embodiments, the vest 40 includes a plurality of protrusions of the snap system and the sensor includes a recess. The concave portion is fixed to the vest 40 by receiving the convex portion.

  In some embodiments of the invention, the vest 40 includes at least one pocket configured to receive and hold an acoustic energy sensor (eg, sensor 22a). Vest 40 also preferably includes an analyzer pocket configured to receive and hold analyzer 24.

  In the embodiment shown in FIG. 6, the vest 40 comprises at least four pockets 42 configured to receive and hold the acoustic energy sensors 22a, 22b, 22c and the motion / direction sensor 22d. Vest 40 also includes an analyzer pocket 44 configured to receive analyzer 24.

  The vest 40 provides mobility to the system 20, as will be apparent to those having ordinary skill in the art.

In another embodiment of the invention, the gastrointestinal motility analysis system 20 comprises at least one, preferably a plurality of sensors, ie physiological sensors. The physiological sensor is configured to record one or more physiological characteristics. This physiological characteristic includes, but is not limited to, ECG, heart rate, SO ₂ , skin temperature, deep body temperature, and respiratory rate.

  According to embodiments of the present invention, additional physiological sensors can be placed on the subject to monitor and / or evaluate one or more physiological characteristics. As an example, a first physiological sensor (ie, a heart rate sensor) is placed near the subject's heart to monitor the heart rate, and a second physiological sensor (ie, a respiratory rate sensor) is placed near the diaphragm to determine the subject's respiratory rate. Can be monitored.

  As shown in FIG. 7, a schematic diagram of an embodiment of a gastrointestinal motility analysis system 50 according to the present invention is shown. As shown in FIG. 7, the system 50 includes multifunctional sensors 22a-22e and 51-58 for monitoring the subject's gastrointestinal function (or motor characteristics), body movements and directions, and physiological characteristics.

In one embodiment of the invention, physiological sensor 51 comprises an ECG sensor configured to monitor cardiac performance and / or function. The physiological sensor 52 includes a heart rate sensor configured to monitor the heart rate of the subject. The physiological sensor 53 includes an SO ₂ sensor configured to monitor the blood oxygen concentration of the subject. The physiological sensor 54 includes a first temperature sensor configured to monitor the skin temperature of the subject. The physiological sensor 55 includes a second temperature sensor configured to monitor the deep body temperature of the subject. The physiological sensor 56 includes a respiratory sensor configured to monitor the subject's respiratory rate and tidal volume.

  As shown in FIG. 7, the system 50 also includes one additional sensor 57. In one embodiment, sensor 57 comprises an acoustic sensor configured to monitor acoustic energy not associated with the stomach, such as cough. In accordance with the present invention, the signal from the acoustic sensor 57 can be used to identify and extract non-stomach related signals or effects that the acoustic energy sensors 22a, 22b, 22c may record.

  According to the present invention, the additional sensors 51-57 can be directly attached to the skin of the subject as well. Sensors 51-57 can also be incorporated into vest 40 as described above.

  As described above, the system 50 includes three acoustic energy sensors 22a, 22b, 22c, but the system 50 may include fewer than three acoustic energy sensors, such as sensor 22a or similar sensors. .

  Although the system 50 includes twelve sensors, sensors 22a-22e, 51-57, it will be understood that any number of sensors can be included. For example, one sensor, three sensors, six sensors, etc. and / or any combination of at least one acoustic energy sensor 22a-22c and zero or more sensors 51-57. For example, the system 50 can include acoustic energy sensors 22a, 22b, motion / direction sensor 22d, physiological sensors 52 and 57, or acoustic energy sensor 22a and physiological sensors 52 and 56.

  A gastrointestinal system including system 50 according to embodiments of the present invention is effective when employed to monitor gastrointestinal function and physiological characteristics of multiple subjects. By way of example, in the case of a pregnant subject, three or more sensors may be placed on the pregnant subject's body to monitor the pregnant subject's gastrointestinal function and at least one physiological characteristic, and at least one physiological characteristic of the fetus. it can. For example, the sensor is disposed in the vicinity of the abdomen region of the pregnant woman subject, and a gastrointestinal sensor (for example, an acoustic energy sensor 22a) that monitors gastrointestinal motility characteristics. A heart rate sensor (for example, physiological sensor 52) is a second heart rate sensor that is disposed in the vicinity of the abdomen region (ie, fetus) of the pregnant woman subject and monitors the heart rate of the fetus.

  Embodiments of the method and system according to the present invention can be employed in multiple applications. This application includes, but is not limited to:

  • Monitor gastrointestinal motility characteristics during pharmaceutical composition studies and clinical trials related thereto, and better evaluate research and clinical data.

  Monitor gastrointestinal function and / or motor characteristics and determine abnormalities, ie gastrointestinal system malfunctions associated therewith.

  Monitor gastrointestinal function and / or motor characteristics during pregnancy. In particular, during high-risk pregnancy that is prone to gastrointestinal disorders.

  Monitor the gastrointestinal function and / or movement characteristics of pregnant subjects and the physiological characteristics of pregnant subjects and fetuses such as heart rate during pregnancy.

  It is easy to employ these methods and systems according to the present invention to facilitate the diagnosis and treatment of various eating disorders. Indeed, as is well known in the art, various gastrointestinal events and associated acoustic energy (or sound) reflect digestive activity. As an example, if one or more strong contraction groups (MMCs) are not present for an extended period of time (eg, 12 hours), this indicates a subject with bulimia or anorexia nervosa. Conversely, if the MMC phase is repeated for a long time, it indicates excessive eating.

EXAMPLES The following examples are provided to enable those skilled in the art to more clearly understand and to practice the present invention. These examples do not limit the scope of the invention, but merely represent representative examples.

Example 1
Six male subjects performed a physical examination first. All subjects passed the initial medical examination. Subjects then stayed at the diagnostic center and fasted (ie, water only) for at least 11 hours before testing began.

  Three acoustic energy sensors were placed on each subject. Sensor # 1 was placed 4-6 inches below the subject's right nipple, i.e. near the bottom of the stomach. Sensor # 2 was placed 11-11.5 inches below the right nipple, ie, near the cecum. Sensor # 3 was placed in the lower left quadrant, approximately 11 inches below the left nipple, ie, near the loudest part of the small intestine / descending colon. The sensor was securely attached to each subject's body with a lightweight, snug-fitting nylon mesh vest, such as vest 40.

  This sensor is a customized Welch-Allen Master Elite Plus stethoscope. Unlike conventional stethoscopes, these pressure-based microphones employ a technique that is less sensitive to indirect vibrations or environmental noise. The sensor further includes a signal processing circuit that improves the signal-to-noise ratio and outputs either a conventional audio signal or monaural line output terminal signal.

  The housing is removed without interfering with the microphone head or signal processing electronics, and the microphone is repackaged. Power and line output terminal signals are delivered to customized front-end analog electronic components via long wires. This wiring makes it easier for the patient to move. In addition, the volume is set to maximum and the onboard filtering is set to “all passes”. Thereby, the frequency band of 100-1200 Hz can be covered.

  All microphone channels were amplified and filtered with an analog two pole 1200 Hz low pass Bessel filter before being sampled at 8000 Hz on a National Instruments DACPad-6015. Data was recorded in 10 minute segments and processed with the software described in National Instruments LabVIEW 7.1.

The gastrointestinal motility characteristics were evaluated by simultaneously performing the Gunma Smograph method. A digestible solid gelatin capsule and a non-degradable tablet with radioactive markers ( ¹¹¹ InCl ₃ and ^99m Tc-DTPA, respectively) were administered to each subject. Because capsules swallowed without water are known to remain in the esophagus for about 2 hours, tablets and capsules were swallowed simultaneously with a glass of water.

  As is well known in the art, radionuclide markers emit multiple gamma rays of characteristic energy. Thus, the contents of the tablet and capsule can be individually tracked.

A reference to confirm that the subject continues to be located within the imaging range of the gamma camera by placing removable stickers in a plastic case containing a minute point source of ¹¹¹ InCl ₃ on each subject's chest and buttocks did. Images were taken every 20 seconds by a gunmachigraph system and an integrated image was recorded every minute. For subsequent analysis, the positions of the tablets and capsules in the gastrointestinal tract were determined and recorded.

  Gastrointestinal sounds were recorded while taking digestible solid capsules and non-degradable tablets. The recorded sound, i.e. the audio file, was stored in an analyzer according to an embodiment of the present invention. The audio file was processed as described above.

  During the initial examination, subjects were required to rest in a supine position under a gun machine grafograph camera. Several parameters were subsequently analyzed. The dominant frequency, duration and intensity of each sound were calculated. A Sound Index (SI) was calculated. SI, as used herein, means the sum of absolute amplitudes for all sounds detected during one minute. The unit is mV / min.

  As described above, it is known that upper tube digestion occurs in a four-stage cyclic pattern in a fasted state. At this time, the maximum contraction of the abdomen (ie, phase 3) is initiated by the strong contraction group (MMC) that proceeds from the abdomen to the ileum of the small intestine. The period between MMCs has been well verified and is generally on the order of 2 hours (although relatively often in the range of 1-3 hours).

  During the examination, clearly discernable MMC was observed in most subjects (~ 66.7%). These were identified as strong SI in all three sensors, with sensors # 1 and # 2 being the largest.

  As shown in FIG. 8, the figure shows a summary of the evaluation results of the gunmachigraph method. As reflected in FIG. 8, in all examinations except for one “abnormal value”, the tablet was discharged from the stomach in 11 to 29 minutes (average 18.88 minutes) by the gun-machograph method. It was judged. Thus, it can be assumed that the test tablet has passed with the gastric juice.

  Interestingly, the “abnormal value” indicated MMC that the tablet did not move. Tablet movement in the stomach occurred only after 1 hour and 40 minutes, corresponding to loud noise and channel 1 SI. The tablet was not completely discharged during the 5 hour 51 minute test. I don't know why, but it highlighted the need to monitor gastrointestinal transit.

  9 to 15 show graphs reflecting sounds recorded by the sensor, that is, sound index (SI) vs. time per minute. As shown in FIGS. 9-15, in all six examinations, the tablet whose stomach was the contents was discharged during monitoring. Significant bowel sounds and SI were recorded upon drainage. In 5 subjects, channel # 1 (or sensor # 1) monitoring gastrointestinal sounds produced the maximum SI recorded at that time.

  The tablet that landed in the gastric sinus where muscle activity occurred moved in response to the maximum sound of channel # 1. Tablets that landed in the gastric sinus generally moved with a large SI of 2-3. The first or second SI corresponds to movement to the stomach fundus.

  Regarding the “abnormal value”, the intestinal sounds generally agreed with the scintigraphic data. The MMC was about 1 hour 40 minutes (ie, the signal was strong in all three channels) and did not affect the tablet movement. However, significant SI subsequently occurred as the tablet moved from the initial position of the upper gastric floor to the gastric sinus. Subsequently, an intermittent tone was recorded on channel 1, but the tablet did not move. It should be noted that the volume level was very low in the other two sensors. This suggests that the gastrointestinal tract is resting as a whole.

  The test results reflect that in subjects who were lying on their backs, the identifiable bowel sound recorded by the sensor according to the present invention corresponds to the discharge of the tablet, as shown by the Gunmach Chromatography method. Yes. Indeed, the movement of the tablet position in the stomach (gastric sinus or fundus) was characterized by loud sounds. In subjects whose tablets were not excreted from the gastrointestinal tract, an overall quiet sound was detected. In several subjects, MMC could be clearly identified.

  As will be apparent to those skilled in the art, embodiments of the present invention provide one or more of the following advantages.

  Provide methods and systems for monitoring gastrointestinal motility characteristics that are effective when employed in pharmaceutical composition studies and related clinical trials. This allows better evaluation of research and clinical trials.

  Provide a method and system for monitoring gastrointestinal motility characteristics that can be expected to save time and resources related to pharmaceutical compositions and related clinical trials.

  Provide a method and system for monitoring gastrointestinal function that can be easily used by physicians. This is provided for diagnostic purposes in assessing gastrointestinal activity.

  Without departing from the spirit and scope of the present invention, those skilled in the art can make various changes and modifications to the present invention to suit various uses and conditions. All such changes and modifications are properly and fairly included within the equivalent scope of the claims and are intended to do so.

Claims (40)

A system for monitoring a subject's gastrointestinal function,
At least one sensor configured to detect acoustic energy and generate at least one acoustic energy signal representative of the acoustic energy, the sensor being capable of being disposed near a body region of the subject;
A processing unit configured to receive the acoustic energy signal, further processing the acoustic energy signal and determining the occurrence of at least one gastrointestinal parameter from the processing result;
A system characterized by comprising: The system of claim 1, wherein the gastrointestinal parameters include an event selected from the group consisting of gastrointestinal mixing, gastrointestinal emptying, gastrointestinal contraction, gastrointestinal propulsion, and gastrointestinal transit time. The gastrointestinal parameters include events related to gastrointestinal system malfunctions,
The system according to claim 1, wherein the gastrointestinal system malfunction is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and strong contraction group disorder. The system of claim 1, wherein the sensor generates a plurality of acoustic energy signals representative of the acoustic energy. The system according to claim 4, wherein the processing unit is configured to receive and process the plurality of acoustic energy signals, and to determine the occurrence of at least a first gastrointestinal parameter from the result. 6. The system of claim 5, wherein the first gastrointestinal parameter includes gastrointestinal transit time. A system for monitoring a subject's gastrointestinal function,
An acoustic energy sensor that can be placed near the body region of the subject, configured to detect acoustic energy generated by the subject and generate at least one acoustic energy signal representative of the acoustic energy; At least one acoustic energy sensor;
A spatial parameter sensor that can be disposed in the vicinity of the subject's body area to monitor at least one spatial parameter associated with the subject's body and to generate at least one spatial parameter signal representative of the spatial parameter. At least one spatial parameter sensor configured in
A processing unit configured to receive the acoustic energy signal and the spatial parameter signal, and further configured to determine the occurrence of at least one gastrointestinal parameter as a function of the acoustic energy signal and the spatial parameter signal. Processing unit,
A system comprising: The system of claim 7, wherein the spatial parameter sensor comprises a motion sensor configured to monitor body movement of the subject. The system according to claim 8, wherein the spatial parameter includes a body movement of the subject. The system of claim 7, wherein the spatial parameter sensor includes a direction sensor configured to monitor a direction of the subject's body. The system according to claim 10, wherein the spatial parameter includes a body direction of the subject. 8. The system of claim 7, wherein the gastrointestinal parameters include an event selected from the group consisting of gastrointestinal mixing, gastrointestinal evacuation, gastrointestinal contraction, gastrointestinal propulsion, and gastrointestinal transit time. The gastrointestinal parameters include events related to gastrointestinal system malfunctions,
The system according to claim 7, wherein the gastrointestinal system malfunction is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and strong contraction group disorder. A system for monitoring gastrointestinal function and physiological characteristics,
An acoustic energy sensor that can be disposed in the vicinity of a body region of a subject, configured to detect acoustic energy representing gastrointestinal sounds generated by the subject and generate at least a first acoustic energy signal representing the acoustic energy At least one acoustic energy sensor,
A physiological sensor that can be disposed in the vicinity of the body region of the subject, the physiological sensor configured to detect a physiological characteristic related to the subject and generate at least a first physiological characteristic signal representative of the physiological characteristic, One physiological sensor,
A processing unit configured to receive the first acoustic energy signal and the first physiological parameter signal, further processing the first acoustic energy signal, and determining the occurrence of at least one gastrointestinal parameter from the result A processing unit configured as follows:
A system comprising: 15. The system of claim 14, wherein the gastrointestinal parameters include an event selected from the group consisting of gastrointestinal mixing, gastrointestinal evacuation, gastrointestinal contraction, gastrointestinal propulsion, and gastrointestinal transit time. The gastrointestinal parameters include events related to gastrointestinal system malfunctions,
The system according to claim 14, wherein the gastrointestinal system malfunction is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and strong contraction group disorder. 15. The physiological characteristic of claim 14, wherein the physiological characteristic includes a physiological characteristic selected from the group consisting of heart rate, blood pressure, blood gas saturation, respiratory rate, skin temperature, and electrical pulses related to cardiac function. system. A system for monitoring gastrointestinal function and physiological characteristics,
An acoustic energy sensor that can be disposed in the vicinity of a body region of a subject, configured to detect acoustic energy representing gastrointestinal sounds generated by the subject and generate at least one acoustic energy signal representing the acoustic energy At least one acoustic energy sensor,
A spatial parameter sensor that can be disposed in the vicinity of the subject's body area to monitor at least one spatial parameter associated with the subject's body and to generate at least one spatial parameter signal representative of the spatial parameter. At least one spatial parameter sensor configured in
A physiological sensor that can be disposed near a body region of the subject, the physiological sensor configured to detect a physiological characteristic associated with the subject and generate at least one physiological characteristic signal representative of the physiological characteristic; One physiological sensor,
A processing unit configured to receive the acoustic energy signal, the spatial parameter signal, and the physiological parameter signal, further determining the occurrence of at least one gastrointestinal parameter as a function of the acoustic energy signal and the spatial parameter signal A processing unit configured to:
A system characterized by comprising: The system of claim 18, wherein the spatial parameter sensor comprises a motion sensor configured to monitor movement of the subject's body. The system of claim 19, wherein the spatial parameter includes a body movement of the subject. The system of claim 18, wherein the spatial parameter sensor includes a direction sensor configured to monitor a direction of the subject's body. The system of claim 21, wherein the spatial parameter includes a body orientation of the subject. 19. The system of claim 18, wherein the gastrointestinal parameters include an event selected from the group consisting of gastrointestinal mixing, gastrointestinal evacuation, gastrointestinal contraction, gastrointestinal propulsion, and gastrointestinal transit time. The gastrointestinal parameters include events related to gastrointestinal system malfunctions,
19. The system according to claim 18, wherein the gastrointestinal system malfunction is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and strong contraction group disorder. 19. The physiological characteristic of claim 18, wherein the physiological characteristic includes a physiological characteristic selected from the group consisting of heart rate, blood pressure, blood gas saturation, respiratory rate, skin temperature, and electrical pulses related to cardiac function. system. A method for determining gastrointestinal parameters for a subject comprising:
Detecting acoustic energy generated by the subject's gastrointestinal system and generating an acoustic energy signal representative of the acoustic energy;
Detecting at least one spatial parameter for the subject and generating a spatial parameter signal representative of the spatial parameter;
Determining at least one gastrointestinal parameter as a function of the acoustic energy signal and the spatial parameter signal;
A method characterized by comprising: 27. The method of claim 26, comprising adjusting the step of detecting the acoustic energy using the spatial parameter signal. 27. The method of claim 26, wherein the spatial parameter includes a body movement of the subject. 27. The method of claim 26, wherein the spatial parameter includes a body orientation of the subject. 27. The method of claim 26, wherein the gastrointestinal parameters include events selected from the group consisting of gastrointestinal mixing, gastrointestinal emptying, gastrointestinal contraction, gastrointestinal propulsion, and gastrointestinal transit time. The gastrointestinal parameters include events related to gastrointestinal system malfunctions,
27. The method according to claim 26, wherein the gastrointestinal system malfunction is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and strong contraction group disorder. A method for determining gastrointestinal parameters for a subject comprising:
Detecting acoustic energy generated by the subject's gastrointestinal system and generating an acoustic energy signal representative of the acoustic energy;
Detecting at least one spatial parameter for the subject and generating a spatial parameter signal representative of the spatial parameter;
Detecting at least one physiological characteristic for the subject and generating at least one physiological parameter signal representative of the physiological characteristic;
Determining at least one gastrointestinal parameter as a function of the acoustic energy signal and the spatial parameter signal;
A method characterized by comprising: The method of claim 32, comprising adjusting the step of detecting the acoustic energy using the spatial parameter signal. The method of claim 32, wherein the spatial parameter includes a body movement of the subject. The method of claim 32, wherein the spatial parameter includes a body orientation of the subject. 33. The method of claim 32, wherein the gastrointestinal parameters comprise an event selected from the group consisting of gastrointestinal mixing, gastrointestinal evacuation, gastrointestinal contraction, gastrointestinal propulsion, and gastrointestinal transit time. The gastrointestinal parameters include events related to gastrointestinal system malfunctions,
The method according to claim 32, wherein the gastrointestinal system disorder is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and strong contraction group disorder. 33. The physiological characteristic of claim 32, wherein the physiological characteristic includes a physiological characteristic selected from the group consisting of heart rate, blood pressure, blood gas saturation, respiratory rate, skin temperature, and electrical pulses related to cardiac function. Method. A method for monitoring gastrointestinal function and physiological characteristics of multiple subjects comprising:
Detecting first acoustic energy generated by the gastrointestinal system of the first subject and generating a first acoustic energy signal representative of the first acoustic energy;
Detecting a first physiological characteristic associated with the first subject;
Detecting a second physiological characteristic for the second subject;
Determining at least one gastrointestinal parameter for the first subject as a function of the first acoustic energy signal;
A method characterized by comprising: 40. The method of claim 39, wherein the second subject includes the fetus of the first subject.

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