MX2010012218A - Method and system for monitoring gastrointestinal function and physiological characteristics. - Google Patents

Abstract

A system and method for evaluating gastrointestinal motility and, optionally, other physiological characteristics (e.g., pulse rate) that can be effectively employed to acquire one or more signals associated with acoustic energy (i.e. sound) emanating from an abdominal region of a body and determine at least one gastrointestinal parameter or event based on the acoustic energy signal(s) is described. The gastrointestinal parameter can include a gastrointestinal event, including gastrointestinal mixing, emptying, contraction and propulsion, and gastrointestinal transit time, or a gastrointestinal system disorder, including reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and a migrating motor complex disorder.

Description

METHOD AND SYSTEM TO ONITORE THE FU NTION | GASTROINTESTINAL AND THE PHYSIOLOGICAL CHARACTERISTICS i Field of Invention ' The present invention relates generally to non-invasive evaluation methods of gastrointestinal function and to physiological characteristics.

Background of the Invention Advances in the pharmaceutical industry in recent decades have been fundamental in extending the duration and quality of human life. In addition to new compounds, advances in the formulation of oral medications and methods of administration have helped to improve efficacy and minimize the dose and reduce side effects. However, the digestive tract of the human body is heterogeneous, and differences in digestive enzymes, absorption rates, microflora and other factors make certain sites in the gastrointestinal tract more or less ideal for delivering specific medications. j Pharmaceutical companies have concentrated efforts on the directed administration of drugs, that is, place and speed of 1 release of the drug in the gastrointestinal tract (G l). These efforts have led to variations in the forms of basic administration designs, for example, hard gel versus tablet capsule, I coating formulations, etc. , and, more recently, the advanced control with respect to the size of the micro and nano particles. S | all right These advances have proven to be beneficial, the humanitarian element remains: the Gl system is intensely variable, both inter j and intra-subject. A key variable, gastrointestinal motility and, therefore, the gastrointestinal (or digestive) transit time, complicates the determination of the ideal targeted administration of drugs. | a pharmaceutical formulation. Indeed, as is well known in the art, if a pharmaceutical formulation administered orally, for example, gel capsules containing a pharmaceutical formulation, exits the gastrointestinal tract before the optimal dissolution and, therefore, absorption, the On the other hand, it has been found that in some cases, the capsule can remain in the upper gastrointestinal tract (ie, upper fundus) for long periods of time (eg,> 5 hours). ).

It is also well known that there is a direct relationship between and slow gastrointestinal motility and gastrointestinal function. Of course, in many cases, gastrointestinal motility may reflect a normal and / or abnormal gastrointestinal function, for example, gastrointestinal obstruction. j Several methods and systems have been used to evaluate gastrointestinal motility and transit time. A commonly used method involves scintigraphy. There are, however, several significant drawbacks associated with scintigraphy. < 1 One of the drawbacks associated with scintigraphy is that the The method is currently limited to a small number of facilities and experts due to the problems (and controls) associated with the handling of radiological substances and equipment expenses. Another disadvantage is that clinical trials of large-scale drugs are impractical.

Other methods and systems to assess gastrointestinal motility include the acquisition and evaluation of sounds Gastrointestinal For example, in U.S. Patent No. 5,301,679, there is disclosed a method and system for providing diagnostic information for various diseases, including diseases of the gastrointestinal tract, by capturing body sounds with a microphone placed on the surface of the body or Inserted orally or rectally into the gastrointestinal tract.

Other systems also use microphones sensitive to Gastrointestinal sounds within the specific frequency ranges and are exemplified by Dalle, et al., "Computer Analysis In Bowel Sounds," Computers in Biology and Medicine, vol. 4 (3-4), p. 247-254 (Feb. 1975); Sugrue et ai, "Computerized Phonoenterography: The Clinical Investigation of the New System", Journal of Clinical Gastroenterology, vol. 18, No. 2, pgs. 139-144 (1994); Poynard, et al., "Qu'attendre des systemes experts pour le diagnostic des trojubles fonctionnes intestinaux", Gastroenterology Clinical Biology, pp. 45c-48c (1990). ? I A significant disadvantage associated with conventional acoustic methods and systems is that the scope of information that is may derive from the recorded sounds is limited. In fact, there Little or no disclosure directed to the relationship between gastrointestinal sounds and gastrointestinal transit times. ' Therefore, it would be desirable to provide a method and a system I to evaluate gastrointestinal motility and determine the time of gastrointestinal transit by abdominal auscultation.

Summary of the Invention The embodiments of the present invention provide systems and methods for monitoring gastrointestinal function and, optionally, other physiological parameters, such as pulse rates and i breathe. The systems and methods of the invention can thus provide a variety of information, which includes the gastrointestinal transit time and other physiological parameters. j In accordance with one aspect of the invention, there is provided a system and method for monitoring gastrointestinal function that can be effectively employed to acquire one or more signals associated with acoustic energy (i.e., sound) from an abdominal region of a patient. body and determine at least one gastrointestinal parameter based on the acoustic energy signal (s). ! In accordance with one embodiment of the invention, there is thus provided a system for monitoring the gastrointestinal function of a subject comprising: at least one sensor mountable on or in a subject's body, the sensor is adapted to sense acoustic energy and generate at least one acoustic energy signal representing the acoustic energy, and (b) a processing unit adapted to receive the acoustic energy signal, the processing unit is also adapted to process the acoustic energy signal and determine the I occurrence of at least one parameter or gastrointestinal event.

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

In one embodiment, the gastrointestinal parameter comprises an event associated with a disorder of the gastrointestinal system that is I selects from the group consisting of reflux disease, irritable bowel syndrome, ulcerative colitis, constipation, diarrhea, and a motor-mitigating complex disorder.

According to another embodiment of the invention, a system for monitoring gastrointestinal function and physiological characteristics is provided, comprising: (a) at least one acoustic energy sensor mountable on or in a region of the body of a subject, the acoustic energy sensor is adapted to detect the acoustic energy representing a gastrointestinal sound generated by the subject and generate a signal of acoustic energy representing the acoustic energy, (b) at least one physiological sensor mountable on a region. of the subject's body, the physiological sensor j is I adapted to detect an associated physiological characteristic cpn the I subject and generate a physiological characteristic signal that represerita the physiological characteristic, and (c) a processing unit adapted to receive the signals of acoustic energy and characteristics I i I physiological, the processing unit is further adapted to process the acoustic energy signals. and of physiological characteristics and determine the occurrence of at least one gastrointestinal parameter or event as a function of the acoustic signal. 1 According to another embodiment of the invention, a system for monitoring the gastrointestinal function of a subject is provided, comprising: (a) at least one acoustic energy sensor mohtable close to a region of the body of the subject, the acoustic energy sensor is adapted to detect the energy the acoustics generated by the subject and generate at least one acoustic energy signal representing the acoustic energy, (b) at least one mountable spatial parameter sensor close to a region of the subject's body, the sjensor i of the spatial parameter of the sensor is adapted to monitor at least one spatial parameter related to the subject's body and generate at least one spatial parameter signal representing the spatial parameter, and (c) an adapted processing unit! to receive the acoustic energy and spatial parameter signals, the processing unit is also adapted to determine the occurrence ! of at least one gastrointestinal parameter as a function of acoustic energy and spatial parameter signals.

In one embodiment, the spatial parameter sensor comprises a motion sensor that is adapted to monitor the movement of the subject's body and the spatial parameter comprises the movement of the subject's body.

I In one embodiment, the sensor of the spatial parameter comprises a orientation sensor that is adapted to monitor the orientation of the subject's body and the spatial parameter comprises the orientation of the subject's body.

According to another embodiment of the invention, a system for monitoring gastrointestinal function and physiological characteristics is provided, comprising: (a) at least one energy sensor I mountable acoustics close to a region of the body of a subject, the acoustic energy sensor being adapted to detect the energy ,. acoustics generated by the subject and generate at least one signal of acoustic energy i representing the acoustic energy, (b) at least one sensor of mountable spatial parameter close to a region of the body of the subject, the sensor being adaptive spatial parameter to monitor at least one spatial parameter associated with the subject's body and generate at least one spatial parameter parameter that Represents the spatial parameter, (c) at least one physiological sensor I mountable close to a region of the body of the subject, the physiological sensor i being adapted to detect a physiological characteristic associated with the subject and generate at least one signal of physiological characteristic representing the physiological characteristic, and (d) a processing unit adapted to receive the signals of acoustic energy, spatial parameter and physiological characteristic, the processing unit is further adapted to determine the occurrence of at least one gastrointestinal parameter as a function of the acoustic energy and spatial parameter separations. 'In one embodiment, the spatial parameter sensor comprises an i i I I I i movement sensor that is adapted to monitor the movement of the subject's body and the spatial parameter comprises the movement of the subject's body.; In one embodiment, the spatial parameter sensor comprises an orientation sensor that is adapted to monitor the orientation of the subject's body and the spatial parameter comprises the orientation of the subject's body. ! In accordance with another embodiment of the invention, It provides a method for determining a gastrointestinal parameter associated with a subject, comprising the steps of: (a) detecting the acoustic energy generated by the subject's gastrointestinal system and generating an acoustic energy signal representing the acoustic energy, (b) detecting at least one i-parameter associated with the subject and generating a spatial parameter signal representing the spatial parameter, and (c) determining at least one gastrointestinal parameter as a function of acoustic energy and spatial parameter signals. ! In accordance with another embodiment of the invention, there is provided a method for determining a gastrointestinal parameter associated with a subject, comprising the steps of: ! (a) detecting the acoustic energy generated by the gastrointestinal system of the subject and generating a signal of the acoustic energy representing the acoustic energy, (b) detecting at least one i-parameter associated with the subject and generating a parameter signal spatial parameter that represents the spatial parameter, (c) they detect a physiological characteristic associated with the subject and generate at least i a physiological characteristic signal representing the physiological characteristic; and (d) determining at least one gastrointestinal parameter as a function of the acoustic energy and spatial parameter signals. 1 In accordance with another embodiment of the invention, there is provided a method of monitoring the gastrointestinal function and the physiological characteristics of multiple subjects, comprising the steps of:! i (a) first detecting the acoustic energy generated by the gastrointestinal system of a first subject and generating a first acoustic energy signal representing said first acoustic energy, (b) detecting a first physiological characteristic associated with the first subject, (c) ) detect a second physiological characteristic associated with j a second subject, and (d) determine at least one parameter gastrointestinal event associated with the first subject as a function of ! first signal of acoustic energy.

In one embodiment, the second subject comprises a fetus of the first subject. ] Brief Description of the Drawings j Figure 1A is an illustration of a part of a human torso showing a normal gastrointestinal tract; j Figure 1 B is an illustration of a human stomach; Figure 2A is a schematic illustration of one embodiment of a gastrointestinal analysis system, in accordance with the invention; i i i Figure 2B is a schematic illustration of another embodiment of the gastrointestinal analysis system shown in Figure 2 ?, according to the invention; Figure 3 is an additional illustration of the partial human torso i shown in Figure 1, showing the placement of gastrointestinal sound (or acoustic) sensors, in accordance with one embodiment of the invention; I Figure 4 is a schematic illustration of an analyzer, showing the subsystems or modules thereof, in accordance with one embodiment of the invention; j Figure 5 is a graphic illustration of a cumulative movement parameter (AccM) as a function of time, according to the invention; j Figure 6 is a further illustration of a portion of a human torso having a system vest disposed therein, in accordance with one embodiment of the invention; Figure 7 is a schematic illustration of a gastrointestinal motility analysis system having additional physiological sensors, in accordance with another embodiment of the invention; Figure 8 is a summary of the scintigraphy results acquired during a study of gastrointestinal motility, and | I Figures 9-15 are graphic illustrations of gastrointestinal sound signals, which reflect gastrointestinal sounds I acquired during the gastrointestinal motility study summarized in Figure 8.! I i Detailed description of the invention Before describing the present invention in detail, | it should be understood that this invention is not limited to the structures, apparatuses, systems, materials or methods particularly exemplified as such, of course, may vary. Therefore, even a Number of similar or equivalent apparatus, systems and methods to those described herein may be used in the practice of this I and invention, the modalities of the apparatuses, systems and methods in accordance with the present invention are described below] It should also be understood that simulated referenced characters generally refer to the same parts or elements in all I views shown in the figures. j Unless defined otherwise, all scientific terms I and technicians used in this document have the same meaning commonly understood by an expert in the field to which the invention pertains. In addition, all publications, patents and patent applications cited in this document, whether above or below, are incorporated I by reference in its entirety. j 1 Finally, as used in this description and appended claims, the singular forms "a", "the", "the" and "an" include plurals unless the content clearly dictates otherwise. Thus, for example, the reference to "a sensor" includes two or more sensors; the reference to "a gastrointestinal event" includes two more events and similar ones. ! Defi n iciones j i I j ! I I i The term "pharmaceutical composition", as used herein, means and includes any compound or composition of matter or combination of components, which, when administered to an organism (human or animal), induces a desired pharmacological and / or physiological effect. The term therefore encompasses substances traditionally considered as active, drugs, prodrugs, and bioactive agents, as well as biopharmaceuticals (eg, peptides, hormones, nucleic acids, gene constructs, etc.).

The term "pharmaceutical", as used herein, means and includes a pharmaceutical composition that precipitates acoustic energy or a gastrointestinal sound (or sounds) of the gastrointestinal tract when Orally administered to a human or animal, such as, without I limitation, pharmaceutical compositions in the form of hard tablets, I gel capsules (hard and soft), caplets and other solid dosage forms.

The term "ingestible," as used herein, means and includes I any substance or element that precipitates acoustic energy or a gastrointestinal sound (or sounds) of the gastrointestinal tract when administered orally to a human or animal. An "ingestible" can therefore comprise a pharmaceutical composition, as well as a non-pharmaceutical composition, such as, without limitation, a placebo. ' The term "gastrointestinal function", as used herein, means and includes, without limitation, the operation of all organs and associated structures, with the gastrointestinal system. I The terms "gastrointestinal system disorder" and "event adverse of the gastrointestinal system, "as used herein, signify and include, without limitation, any dysfunction of the gastrointestinal system, including, without limitation, a dysfunction that impedes the digestive process, such as gastrointestinal obstruction.

The term "gastrointestinal event", as used herein, means e j includes an activity or function associated with the gastrointestinal system, including, without limitation, mixing, emptying, contraction and I Gastrointestinal propulsion. A "gastrointestinal event" may also comprise an event associated with a "gastrointestinal system disorder" or "adverse event of the gastrointestinal system!", Such as, without limitation, reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and a phase disorder i mitigating motor complex (MMC). j The term "gastrointestinal parameter", as used | here, it means and includes a characteristic associated with gastrointestinal function, which includes, without limitation, a gastrointestinal event and gastrointestinal transit time. ' The term "gastrointestinal sound", as used herein, means and includes acoustic energy (and all the signals contained therein) ! generated by a gastrointestinal event. j The term "gastrointestinal transit time", as used herein, is understood to mean the time of mobility through one or more sections of the gastrointestinal tract that may be impacted by the composition of the passing materials, condition of the tract. gastrointestinal, psychological stress, gender and other factors. "Time of I i i i Gastrointestinal transit "is a generic term that can be used I to describe the global gastrointestinal transit time, the background-rectal transit time, and various other motility times through one or more sections of the gastrointestinal tract.

The term "overall gastrointestinal transit time", as used herein, means that the motility time of a pharmaceutical form is ingestible from the point where it is administered through its intended route (eg oral, rectal) through the different sections of the tract i I gastrointestinal and its exit from the body. ! The term "bottom-rectal gastrointestinal transit time" as used herein, means that the motility time of a pharmaceutical or ingestible form from entry to the bottom of the stomach through expulsion from the rectum (see Figs. 1A and 1B). I The term "signal voltage envelope", as used herein, refers to an envelope that is derived from a plurality of signal voltages of acoustic energy. The "signal voltage envelope" has upper and lower limits defined by the voltages of the acoustic energy signal.

The term "signal amplitude envelope", as used herein, means an envelope that is derived from a plurality of acoustic energy signal amplitudes. The "signal amplitude envelope" has upper and lower limits defined by the amplitudes of the acoustic energy signal.

The term "Vumbrai", as used here, means the minimum voltage at which values can be considered significant. In accordance with the invention, if the signal voltage envelope is below V there is no response (ie, the signal is below the sensitivity of the detector). If the envelope of the signal voltage is larger than i the V for more than a pre-determined amount of time, the value is considered significant. i The terms "physiological characteristic" and "physiological parameter", as used herein, mean and include any associated feature.

With the organism (human or animal) and / or organic function of the is not a gastrointestinal parameter, including, without limitation pulse rate, blood pressure, saturation blood (eg, oxygen saturation), respiratory rate, skin temperature, and core temperature. The terms indicated i also include pharmacokinetic parameters (PK).

I The term "spatial parameter", as used here, means I it includes any feature associated with the orientation of a subject's body (for example, if a subject is supine, prone, seated, standing, etc.) and / or the movement of the body (for example, if a i subject is standing, changing body position, walking, etc. ) The terms "spatial parameter value" and "spatial parameter i", as used herein, mean and include a numerical value representing a spatial parameter and / or the effect of a "spatial parameter" on a parameter or gastrointestinal event . | I The term "subject", as used herein, means and includes a human or an animal. The term also includes an unborn human, that is, fetus, or animal. i The present invention provides systems and methods] for monitoring gastrointestinal function and, optionally, other i physiological characteristics associated with a patient or subject. How I know I indicate in detail in this document, in some modalities, the Methods and systems of the invention can be effectively employed to acquire one or more signals associated with acoustic energy (/ e sound) that comes from an abdominal region of a subject body and determine (i) at least one parameter gastrointestinal i based on the acoustic energy signal (s) and / or the start of it, I and / or (ii) an event associated with a disorder of the gastrointestinal system (and / or a disorder of the gastrointestinal system) and / or the beginning of the same.

As described here in detail, some embodiments of the systems and methods of the invention are also adapted to take j effectively account for the spatial parameters associated with the subject, such as the orientation and / or movement of the subject's body.

The methods and systems of the invention can also be effectively used to acquire one or more signals associated with a physiological parameter or characteristic, such as pulse rate, respiratory rate and blood pressure.

The implementation of the methods and systems of the embodiments of the present invention, as described herein, may involve performing or completing the manually selected tasks or steps, automatically, or a combination embodiments of the present invention, several steps selected by hardware or software could be implemented in any system I I of operation or any firmware or a combination of the same. For example, as hardware, the steps selected from the embodiments of the invention could be implemented as a chip or a circuit.

As software, the selected steps of the modalities of the Invention could be implemented as a plurality of software instructions that are executed by a computer using any suitable operating system. In any case, the selected steps of the method and system of the invention could be described as they are carried out by a data processor, such as a computing platform for the execution of a plurality of i instructions.

Referring first to Figure 1A, an illustration of a typical gastrointestinal tract (designated generally "1 0") is milied. As illustrated in Figure 1, the gastrointestinal tract 10 generally includes the esophagus 12, the stomach 1 3, i i small intestine 15 and large intestine 16. The large intestine includes caecum 1 7, colon 18 and rectum 19. i Referring to Figure 1 B, stomach 1 3 includes the region of the bottom (or fundus) 14a and the pyloric antrum (or antrum) 14b. j As is well known in the art, gastrointestinal motility (in a normal male / female subject) is typically characterized by the repeated occurrence of three distinct phases, called the migratory motor complex (MMC). Phase 1 comprises a period or phase ele no contractions. Phase 2, which follows from phase 1, comprises a phase i of intermittent contractions of variable amplitude. Phase 3, j that | i follows from phase 2, comprises a phase of repetitive propagating contractions. The migratory motor complex has an average cycle of 80 to 150 minutes. j It is also well established and known in the art that distinctive sounds come from the gastrointestinal tract during each of the phases indicated. See, for example, Tomomasa T., et al.

"Gastrointestinal Sounds and Migrating Motor Complex in Fasted Humans," The American Journal of Gastroenterology, vol. 94, Ño. 2, pgs. 374-381 (1999), Farrar ef al. J., "Gastrointestinal Motil ijty as Revealed by Study of Abdominal Sounds", Gastroenterology, vol. 29, No. i 5, pgs. 789-800 (1955), W. B. Cannon, "Auscultation of the Rhythmic Sounds Produced by the Stomach and Intestines," Laboratory of Physiology, VI, pgs. 339-353 (1905).

As indicated above, although there have been several studies related to gastrointestinal sounds and publications resulting from them, there is little information regarding the relationships between gastrointestinal sounds and the migratory motor complex. There is also very little information about the relationship between the Sojnids I gastrointestinal and gastrointestinal transit time.

Referring now to Figure 2A, a schematic illustration of one embodiment of a gastrointestinal analysis system i of the invention is shown. As illustrated in Figure 2A, system 20 includes a plurality of acoustic energy sensors 22a, 22b, 22c and at least one analyzer 24. In the mode i shown in Figure 2A, the system 20 also includes a means of display 26.

According to the invention, the acoustic energy sensors 22a, 22b, 22c can independently comprise contact or non-contact transducers which detect vibrations and / or sounds at or near the surface of a subject's skin and convert these vibrations and / or sounds in electrical signals. Other sensors may include internal sensors, such as intra-esophageal sensors and intra-gastric sensors, which are introduced into the subject (or patient) using a nasal-gastric tube or the like. ! By way of example, the acoustic energy sensors 22a, '22b, i 22c can be electronic stethoscopes, contact microphones, non-contact vibration sensors, such as capacitive or optical sensors, or any other suitable type of sensors. The sensors of The acoustic energy 22a, 22b, 22c are preferably, but not necessarily, selected to have acoustic impedance that matches the impedance of the skin surface to provide optimal acoustic coupling to the surface of the skin. Even more, due to the background noise and the relatively low amplitude of the vibrations or I sounds that are generated on or near the surface of the foot by gastric sounds, the acoustic energy sensors 22a, 22b J 22c are also preferably, but not necessarily, selected i to provide a high signal-to-noise ratio, high sensitivity and / or a good surround capacity of ambient noise. j In accordance with the invention, the acoustic energy sensors 22a, 22b, 22c and the spatial parameter sensors 22d, 22e send i ! i I I low level (ie, low power) electrical signals through wires 23, or any other suitable means, such as wireless radio frequency, infrared, etc. , to the analyzer 24. i A suitable acoustic energy sensor that can be employed within the scope of the invention is described in U.S. Patent No. 6, 51 2, 830. j Although three acoustic energy sensors are shown in FIG. 2A, fewer additional sensors or sensors can be used to detect gastric sounds in multiple locations in the subject's abdomen, or any other location in the subject's body that; are of interest and may be useful in the evaluation of gastrointestinal function, and / or gastrointestinal motility (and / or transit time). For example, a single acoustic energy sensor can be strategically placed in the subject's body and / or sequentially moved to different key locations in the subject's body to detect gastrointestinal sounds. j Referring now to Figure 2B, it is shown; other I mode of the gastrointestinal analysis system 20. As illustrated in Figure 2B, the system 20 similarly includes the acoustic energy sensors 22a, 22b, 22c, the analyzer 24 and the display device 26. However, in this embodiment, the system 20 also includes at least one, preferably, two parameter sensors I i space 22d, 22e. ( I In one embodiment of the invention, the spatial parameter sensor 22d comprises a motion sensor which is adapted I I i I ! i to monitor the spatial parameters associated with the movement of the subject's body, e.g., if the subject is stopped, change the position of the body, walking, etc., and transmit at least one movement signal representing the same to the analyzer 24.

In one embodiment of the invention, the spatial parameter sensor 22e comprises an orientation sensor that is adapted to monitor the spatial parameters associated with the orientation of the subject's body, for example, if the subject is supine, prostrate, sitting, standing, etc., and transmitting at least one orientation signal representing the same to the analyzer 24.

As will be readily appreciated by one of ordinary skill in the art, body movement and orientation can be determined by a number of conventional and medium methods, including, without limitation, optical encoders, proximity switches and the Hall effect, laser interferometry. and accelerometers.

As will also be appreciated by one of ordinary skill in the art, the movement and orientation sensors 22d, 22e may comprise multifunctional, integral devices. Thus, in some embodiments of the invention, the sensors 22d, 22e comprise multifunctional 3-axis accelerometers (hereinafter referred to as "motion / orientation sensors"). By virtue of the multifunctional capability of 3-axis accelerometers, in some cases the I indicated modalities, only one motion / orientation sensor is used, e.g., 2d, to monitor body movement and orientation. i As discussed in detail below, the analyzer 24 can i include amplifiers, filters, transient protection and another set of circuits that amplifies the signals sent by the energy sensors Acoustics 22a, 22b, 22c, (and, optionally, motion / orientation sensors 22d, 22e), which attenuates noise signals, and / or which reduces distortion effects. In particular, the analyzer 24 may include a low pass filter having a cutoff frequency in the range of Approximately 1100 to 1400 Hz. In one embodiment of the invention, the low pass filter has a cutoff frequency in the range of i approximately 1200 - 1300 Hz. j Alternatively or additionally, a high pass filter can be incorporated within the analyzer 24. This high pass filter can, for example, have a cutoff frequency in the range of about 70 to 90 Hz such that the noise and the sounds are not dehydrated , such as muscle noise, respiratory sounds, cardiac symptoms, non-gastric gastrointestinal sounds or any other unwanted sounds or noise are substantially attenuated or They are removed before the signals sent by the acoustic energy sensors 22a, 22b, 22c are processed further. j I The spectral energy of potentially disturbing non-gastrointestinal sounds is frequently in a frequency band of approximately 20-250 Hz. However, the amplitude of these disturbing sounds may be reduced, in some cases significantly reduced, for adult subjects by the considered placement of the acoustic energy sensors 22a, 22b, 22c. I i Referring now to Figure 3, a preferred placement of acoustic energy sensors 22a, 22b1, 22c, movement / orientation sensors 22d, 22e, according to one embodiment of the invention is shown. As illustrated in Figure 3, the acoustic energy sensor 22a is preferably placed in the upper left quadrant close to the gastric fundus, the acoustic energy sensor 22b is I preferably placed in the lower right quadrant proximal to the cecum, and the acoustic energy sensor 22c is preferably placed in the lower left quadrant proximal to the small intestine; more preferably, near the descending colon.

According to the embodiments of the invention, the acoustic energy sensors 22a, 22b, 22c can be arranged in places different from those specifically represented in Figure 3, without departing from the scope and spirit of the invention. For example, the acoustic energy sensor 22a can be placed on a transverse line approximately two thirds of the distance between the navel and the xiphoid to the right of the midline, the acoustic energy sensor 22b can be placed on the margin. left coast and the acoustic energy sensor 22c can be placed jen the I mean line in about half the distance between the navel and the symphysis pubis. j In the embodiment illustrated in Figure 3, the movement / orientation sensors 22d, 22e are preferably arranged I close to the anterior surface of the abdomen, preferably, They are close to the center of the chest region. i I According to the invention, the movement / orientation sensors 22d, 22e may be arranged in a similar manner in places other than those specifically depicted in Figure 3, without departing from the scope of the invention. Also, as indicated above, only one motion / orientation sensor, such as sensor 2d, can be used. ! Referring to the figure. 4, in accordance with one embodiment of the invention, the analyzer 24 is adapted to carry I perform the following functions: i) receive the recorded acoustic energy signals ((or gastrointestinal sound) from the sensors (e.g., acoustic energy sensors 22a, 22b, 22c) 30, (ii) store the energy signals acoustic in a memory means 32, and (iii) projcesar acoustic energy signals (using the signal processing module 33) to, in accordance with the embodiments of the invention, derive at least one gastrointestinal parameter and / or event gastrointestinal (and / or the appearance thereof) relative to it In some embodiments of the invention, the analyzer 24 is further adapted to compare the gastrointestinal parameter or event with at least one physiological characteristic or parameter, such as a parameter i pharmacokinetics (PK), which is induced in a subject by the administration of a pharmaceutical composition. ! In some embodiments of the invention, the analyzer 24 is further adapted to determine an event associated with a disorder of the gastrointestinal system (and / or a disorder of the gastrointestinal system), such as blockage of the digestive system. i In another embodiment of the invention, the analyzer 24 is further adapted to: i) receive the motion and orientation signals recorded from the movement / orientation sensors 22d, 22e through the line 30, (ii) store the motion signals and / or orientation in memory means 32, and (iii) determining at least one gastrointestinal parameter and / or gastrointestinal event (and / or the occurrence thereof) relative thereto and / or gastrointestinal system disorder (and / or a disorder). of the gastrointestinal system) as a function of recorded acoustic energy, movement and / or orientation signals. In this embodiment, the analyzer 24 thus includes algorithms and / or factors derived from spatial parameters (discussed in detail below) that I take into account effectively the spatial parameters reflected in the movement and orientation signals in the parameters (s), Event (s) and gastrointestinal disorder (s) derived. For example, a spatial signal can be used to adjust an acoustic signal. ! As illustrated in Figure 4, the analyzer 24 is also adapted to provide at least one output signal 39 which represents the recorded acoustic energy and / or the movement of the subject's body and / or orientation and / or, according to other embodiments provided by the invention (discussed below), a physiological characteristic, j In accordance with the embodiments of the invention, the module of Signal processing 33 is also adapted to carry out the following: (i) filtering foreign artifacts from signals 34, (ii) i determining an amplitude envelope of the signal based on signals 36, and iii) determining the frequency dominant of the signals 38.

In accordance with the invention, the filtering step 34 can be I carry out with software, e.g., computer program, or hardware. Thus, in some embodiments of the invention, the analyzer 24 is programmed to filter the acoustic energy signals and extract the frequency band of interest from the signals.

In one embodiment, the frequency of interest is in the range of about 70 to 1400 Hz. In another embodiment, the frequency of interest is in the range of about 90 to 1200 Hz. J In accordance with the invention, various conventional programs can be used within the scope of the invention to carry out the indicated filtering step 34. j In other embodiments of the invention, the filtering step 34 is carried out via hardware. In one embodiment, the analyzer circuit includes low and high pass filters that are adapted to filter foreign artifacts from the signals 34. In accordance with the invention, various low and high pass filters can be employed within the scope of the invention. In one embodiment, the high pass filter comprises a. FIR filter of 401 blows balanced, with Blackman windows with a cut fixed at 80 Hz and the low pass filter comprises a FIR filter of 400 blows balanced with Blackman windows, with a cut fixed at ', 1250 I Hz.! In one embodiment, the signal amplitude envelope is determined using a Hilbert shift transform with a 5μseg window As is well known in the art, Hilbert transforms are commonly used to determine an envelope signal.

I See, for example, Tomomasa T., et al. "Gastrointestinal Sounds and Migrating Motor Complex in Fasted Humans", The American Journal of Gastroenterology, vol. 94, No. 2, pgs. 374-381 (1999), Farrar et al. J., "Gastrointestinal Motility as Revealed by Study of Abdominal Soühds", Gastroenterology, vol. 29, No. 5, pgs. 789-800 (1955); which are incorporated as a reference in this document. ! Applicants have found that the Hilbert transform softened the short "dry noises", ie, the intermittent acoustic energy peaks, and transformed the bipolar sound energy signals into a signal that can be easily analyzed using a Vurnbrai sijmple, t as defined above. j i In accordance with the embodiments of the invention, the frequency I The dominant of acoustic energy signals can be determined in a similar manner by various conventional means. In [one mode], the dominant frequency was determined by isolating the peaks > Vumbrai for time > 5 microseconds As indicated above, a key characteristic and véntaja ! of the embodiments of the present invention is the ability of the gastrointestinal analysis systems and methods to explain ! effectively the spatial parameters, .e., the movement of the body i and the orientation, in the determinations of the gastrointestinal parameters, events and disorders. j Referring to Figure 5, a graphic illustration of a cumulative composite motion measure (AccM) as a function of time is shown. The AccM is the sum of both axes of the body X and Y. ! Í I As shown in Figure 5, the acoustic signal of the acoustic sensor (channel 1) captures the tablet leaving the stomach (denoted "a") while the signal of movement / orientation of the sensor i movement / orientation (i.e. 3-axis accelerometer) captures the subject's elevation to a vertical position to ingest a cjomida (denoted "ß"). Figure 5 also shows a change (ie an increase) in I the registered signal resutante of the movement of the subject.

Accordingly, in some embodiments of the invention, the analyzer 24 includes algorithms and / or factors derived from spatial parameters that effectively explain the spatial parameters reflected in the orientation and movement signals in the j (the) gastrointestinal parameter derived (s) , As indicated above, the is To say, the movement of the body and the orientation, can be determined by a series of conventional means, such as encoders.

Optical, proximity and Hall effect switches, laser interferometers and multi-axis accelerometers. According to some modalities, of the invention, the output of these predominantly digital devices, I i. and. signals of movement and / or orientation, is translated into a value of i spatial parameter or factor. j I A matrix is generated and stored in the memory medium 32; i the matrix includes a plurality of body positions and movements, I and the corresponding spatial parameter factors. 1 j Referring to Table I, an exemplary matrix is shown. As shown in Table I, when the subject is standing still and the maximum value or spatial parameter is "0 1 1", as reflected in the i outputs of the X, Y and Z axes Table I The spatial parameter factor can then be used to adjust the recorded acoustic signal. For example, the V umbrai could be adjusted for each of the acoustic energy sensors (e.g.j 22a, 22b, 22c), based on the Gl activity envisaged there.

To take a particular spatial example, if the spatial factor is one (0-1-1, i.e. standing), more emphasis could be put on the signals acoustics of acoustic energy sensors 22b and 22c (see Fig. 6) in the determination of movement Gl, since these sensors would be closer to the internal source of the acoustic signal. ! Another example would be to determine the orientation during sleep, which is shown to be related to gastric emptying. If, during sleep, the spatial parameter was (1 0 0), a greater gastric emptying could be expected because the contents of the stomach are centered in the pylorus. In this example, you could put I a greater emphasis on the acoustic signals of the acoustic energy sensors 22a and 22c (see Fig. 6). ! i Referring again to Figures 2A and 2B, according to the invention, the display means 26 may comprise any suitable means that is capable of providing at least one visual representation representing the recorded acoustic energy signals (pre-and post -processed) and / or body movement and / or body orientation and / or physiological characteristics i registered. In one embodiment, the display means 26 comprises a computer monitor. j In accordance with other embodiments of the invention, the i of display 26 may also comprise an acoustic representation. The acoustic representation can be adapted! to provide a sound or tone that represents, for example, the I body movement, a gastrointestinal event or a CMM phase. The acoustic representation can also be adapted | to provide different sounds or tones that represent movement of the body or a selective gastrointestinal event or a disorder of the I gastrointestinal system or MMC phases or characteristics related to them, for example, the beginning of a phase. J ? The display means 26 can also provide at least one visual representation representing the energy signals. acoustics (pre- and post-processed) and / or body movement and / or j orientation of the body and / or the physiological characteristics recorded, and ! At least one audible sound or tone representing the movement of the I body or at least one gastrointestinal event or physiological characteristic. ! F j i I As will be appreciated by one of ordinary skill in the art, the visualization means 26 can also be an integral or main component of the analyzer 24., As will be appreciated by one of ordinary skill in the art, acoustic energy sensors 22a, 22b, | 22c, i the motion sensor 22d and the orientation sensor 22e (or multifunctional motion / orientation sensors 22d, 22e) of the invention can be placed in the body of a subject in various conventional means. By way of example, sensors 22a, 22b, 22c, 22d, 22e may include an adhesive ring or surface in the housing that is adapted to temporarily engage the subject's skin .; The sensors 22a, 22b, 22c, 22d, 22e can also be attached to the skin of the subject through a medical band or elastic bandage. j Referring now to Figure 6, in one embodiment of the invention, the acoustic energy sensors 22a, 22b, 22c, and a Movement / orientation sensor 22d are placed and maintained in a substantially static position against the body of the subject through a vest 40. According to the invention, the vest 40 may comprise various sizes and materials. In one embodiment, the vest 40 is adjustable and comprises a lightweight mesh material, e. g. , nylon or Lycra®. In a fashion I of the invention, the vest 40 includes at least one pocket that I is configured to receive and accommodate at least one sensor. Preferably, the I vest 40 includes a plurality of pockets that are configured to receive and place a plurality of sensors; the pockets are I I placed to correspond to the selective positions in a body ! of a subject when it is used by the subject. j In another contemplated embodiment, the vest 40 and the sensor (s) include a male-male pressure system. In one embodiment, the vest 40 may include a plurality of female portions positioned from the pressurized system and the sensors may include a portion that can be engaged and therefore secured to the vest 40 by the female receiving portions of the vest. In other embodiments, the vest 40 may include a plurality of male portions of the pressurized system and the sensors may include a portion of a female that can be engaged and, therefore, be secured to the vest 40 by the male portions of the vest receiving vest. j In some embodiments of the invention, the vest 40 includes at least one pocket that is adapted to receive and accommodate a sensor of acoustic energy, e. g. , sensor 22a. The vest 40 also preferably includes a pocket of the analyzer that is adapted to receive and house the analyzer 24. ' In the embodiment shown in Figure 6, the vest 40 includes at least four (4) pockets the 42 adapted to receive and accommodate the ! acoustic energy sensors 22a, 22b, 22c, and motion / orientation sensor 22d. The vest 40 also includes a pocket ! of the analyzer 44 which is adapted to receive the analyzer 24. j As will be evident to someone with normal knowledge in i the technique, the vest 40 provides the system 20 with mobility, i i In other provided embodiments of the invention, the system Gastrointestinal motility analysis 20 includes at least one, preferably, a plurality of additional sensors, i. and. , physiological sensors, which are adapted to record one or more physiological characteristics. Such physiological characteristics include, without limitation, ECG, pulse rate, S02, skin temperature, core temperature and respiratory rate.

In accordance with the embodiments of the invention, the additional physiological sensors can be strategically placed in a subject to monitor and / or evaluate one or more physiological characteristics. By way of example, a first physiological sensor (ie pulse rate sensor) can be placed close to the subject's heart to monitor the pulse rate and a second physiological sensor (ie respiratory rate sensor) can be placed perch of the diaphragm to monitor the breathing rhythm of the subject.

Referring now to Figure 7, it is shown! a schematic illustration of a modality of an analysis system ! Gastrointestinal motility 50, in accordance with the present invention. As illustrated in the figure. 7, the system 50 includes multiple function sensors 22a-22e and 51 to 58 to monitor gastrointestinal (or motility) function, movement of the orientation and orientation, and physiological characteristics of a subject.; In one embodiment of the invention, the physiological sensor 51 comprises an ECG sensor adapted to monitor cardiac output and / or function /, the physiological sensor 52 comprises a sensor of the pulse frequency adapted to monitor the pulse rate of the subject, the physiological sensor 53 comprises a sensor S02 adapted to monitor the oxygen level in the blood of the subject, the physiological sensor 54 comprises a first temperature sensor adapted to monitor the skin temperature of the subject, the physiological sensor 55 it comprises a second temperature sensor adapted to monitor the central temperature of the subject, and the physiological sensor 56 comprises a respiration sensor that is adapted to monitor the respiratory rate and the volume of pulmonary ventilation.

I As illustrated in Figure 7, system 50 also includes an additional sensor 57. In one embodiment, sensor 57 comprises an i i acoustic sensor that is adapted to monitor acoustic energy i that is not gastrointestinal, such as cough. In accordance with the In the invention, acoustic sensor signals 57 can be used to identify and extract non-gastrointestinal signals or artifacts that ! they may have been recorded by the acoustic energy sensors 22a, 22b, 22c. ! According to the invention, the additional sensors 5lj to 57 can similarly be connected directly to the skin of the subject. The sensors 51-57 can also be incorporated in the vest 40, as described above.

As indicated above, although system 50 is shown I with three acoustic energy sensors 22a, 22b, 22c, the system 50 It may include less than three acoustic energy sensors, e.g., the i sensor 22a, or more such sensors. J I It should also be understood that while the system 50 is shown I with twelve (12), ie sensors 22a-22e and 51-57, the system 50 may include any number of sensors, eg, a sensor, three sensors, six sensors, etc. , and / or any combination of at least one of the acoustic energy sensors 22a-22c and zero or more of the sensors 51 to 57. For example, the system 50 may include acoustic energy sensors i, 22a, 22b, the sensor movement / orientation 22d, and physiological sensors 52 and 57 or the acoustic energy sensor 22a and the physiological sensors 52 and 56. j The gastrointestinal systems, in accordance with! the embodiments of the invention, including the system 50, can also ! be effectively employed to monitor the gastrointestinal function and the physiological characteristics of multiple subjects. By way of example, in the case of a pregnant patient, three or more sensors can be strategically placed in the body of the pregnant patient to monitor gastrointestinal function and therefore a physiological characteristic of the pregnant patient and at least one physiological characteristic of the unborn child, eg. , a gastrointestinal sensor i (e.g., acoustic energy sensor 22a) placed close to the abdominal region of the pregnant patient to monitor gastrointestinal motility, a first sensor of the pulse frequency I (eg, physiological sensor 52) disposed close to the heart of the pregnant patient to monitor the pulse rate of the pregnant patient, and a second sensor of the pulse frequency near the abdominal region of the pregnant patient (and, therefore, both, the child still not born) to monitor the frequency of the child's pulse born. | I The modalities of the method and system of the present invention can thus be effectively employed in numerous applications. The applications include, without limitation, the following: · To monitor gastrointestinal motility during the investigation of a pharmaceutical composition and clinical trials related to it, to better evaluate the research and clinical records. I To monitor gastrointestinal function and / or motility and determine abnormalities, that is, disorders of the gastrointestinal system, associated with it. j i To monitor gastrointestinal function and / or motility during pregnancy; particularly, high-risk pregnancies where gastrointestinal obstruction is often found. j · To control the gastrointestinal and / or motilidád function of a pregnant patient and the physiological characteristics of the pregnant patient and the unborn child, e.g., the frequency of the p ^ ulso, during pregnancy. í i The methods and systems of the present invention can also be readily employed to facilitate the diagnosis and treatment of various eating disorders. Indeed, as is well known in the art, various gastrointestinal events and, therefore, the acoustic enjergy (or sound) associated with them, reflect the digestive activity (or its absence). By way of example, a prolonged period of time (for example, 12 hours), without one or more phases of a complex Migratory motor (MMC) could be indicative of an anorexic or bulimic subject. Conversely, a prolonged period of repeated phases of MMC could be indicative of excessive overfeeding. | Examples The following examples are provided to allow! that experts in the field understand more clearly and practice the I Six male subjects were initially provided with a I patient, that is, close to the gastric fundus. Sensor # 2 was placed 1 1 to 1 1 .5 inches below the right nipple, that is, close to the cecum. Sensor # 3 was placed in the lower left quadrant, approximately 1 1 inches below the left nipple, it is to be clecped, near the upper part of the small intestine / descending colon. The sensors were held firmly against the body of; each subject wearing a lightweight, tight-fitting nylon mesh vest, such as vest 40. I The sensors were Welch-Allen Maestro Elite j Plus stethoscopes modified according to use. Unlike traditional stethoscopes, these pressure-based microphones employ 'a I technology that is less sensitive to indirect vibration and therefore to environmental noise. In addition, the sensors also contain signal processing circuitry that improves the signal-to-noise ratio and offer either traditional audio, or mono-output signals. j Without moving the head of the microphone or electronic parts of signal processing, the housing was removed and the microphones i were restructured by passing the power and output signals to I the front analog electronic parts according to specifications with long wiring that allows the mobility of the patient. In addition, the I volume was set at the maximum and the integrated filtering was adjusted to "all-j passes", which comprises a frequency band in the range of 100-1200 Hz.! All microphone channels were amplified and filtered with a low pass through a Bessel low-pass analogue filter of 2 μs and 1 200 Hz alone, and then sampled on a National Instruments DAQPad-6015 at 8000 Hz. they were recorded in 10-minute segments and then processed through software written in National I ntruments Lab View 7.1. ! I I Simultaneously, gammagraphy j was also performed to evaluate gastrointestinal motility. A gelatin capsule! dissolvable hard and a non-disintegrable tablet with radiolabels (111lnCl3 and 99mTc-DTPA, respectively) were administered to subject The tablet and the capsule were taken simultaneously with a glass of water, since it is known that the capsules taken without water can stick in the esophagus for up to two hours.

As is well known in the art, radionucleotide markers emit gamma rays of different characteristic energies. Therefore, the contents of the tablet and the capsule could be tracked separately. j Removable labels containing small nCI3 point sources enclosed in plastic were placed on the chest and each subject's cadence as a reference to ensure consistent placement of the subject under the gamma camera between the photographs. The photographs were taken every 20 seconds and the integrated images were stored every 1 minute by the gamma raphy system. The position of the tablet and the capsule in the gastrointestinal tract were determined and recorded for further analysis. j Gastrointestinal sounds were also recorded during the ingestion of the dissolvable hard gelatin capsule and a non-disintegrable tablet. The recorded sounds i. and. , sound files were stored in an analyzer according to the methods of the invention. The sound archives were processed as mentioned above. j I During the first part of the study, were the subjects asked? that they remained silent in a supine position under the scintigraphy camera. Several parameters were analyzed later. The dominant frequency of individual sound, duration and intensity They were also calculated. j The sound index (or SI) was also calculated. YES, as used here, means the sum of the absolute amplitudes for all sounds detected during a period of one (1) minute, expressed as mV / min. i As mentioned above, it is known that in a fasting state, digestion of the upper tract occurs in a 4-stage cyclic pattern with the longer contractions of the stomach (ie, phase 3) generally initiated with a migratory motor complex (MMCi). ) that proceeds from the stomach to the ileum of the small intestine. The term i between the MMC's has been well established and is typically around two hours (although the times vary from 1 to 3 I hours are frequent). } i During the studies, MMCs were clearly identified in the majority of the subjects (~ 66.7%) as identified i by Sl's long in the three sensors, the highest being the # 1 and # 2 sensors j Referring now to Figure 8, a summary is shown I of the scintigraphy evaluation. As reflected in Figure | 8, in all the studies, but one, that is, an "atypical" scan, determined that the tablets were expelled from the stomach between 29 minutes (mean of 8.88 minutes). Therefore, it can be inferred that the test tablets passed with stomach fluid. ! Interestingly, the "atypical" showed an MMC without tablet movement. The movement of the tablet in the stomach only came after corresponding to a long sound and YES on channel 1 about 1 hour, 40 minutes. The expulsion of the complete tablet did not occur during the entire duration of the study, that is, 5 hours and 51 minutes. The cause of this is uncertain, but highlights the need to monitor gastrointestinal transit.

Referring now to Figures 9-15, graphs are shown that reflect the sounds recorded by the sensors, ie, the sound rates per minute as a function of time. As shown in figures 9-15, in all 6 studies, where gastric emptying of the tablet occurred during monitoring, significant bowel sounds and Sl's were recorded at the time of emptying. In 5 subjects, channel # 1 (or sensor # 1), which monitored the gastric solids, produced the highest SI registered up to that time. | The tablets that landed in the antrum, where the muscle activity takes place, moved corresponding to the first longest sound in channel # 1. The tablets that landed in the antrum usually I they took two or three long Sl's to move, the first or second SI's correspond to the movement in the background. J For the "atypical", intestinal sounds usually ! coincided with the scintigraphy data. There seems to be an MMC of ! about 1 hour, 40 minutes (that is, a strong signal on all three channels), which did not affect the movement of the tablet. Nevertheless, ? channel 1, but there was no movement of the tablet. Remarkable, however, are the very low levels of sound in the other two sensors, which implies digestive rest in general. ' The results of this study reflect that in subjects who are at rest in a supine position, the discernible bowel sounds recorded by a sensor of the invention correspond to the ejection of the tablet, as shown by scintigraphy. In fact, i the movements of the position of the tablet (antrum or bottom) jen the Stomachs were also marked by long sounds. In general I soft sounds were detected in the patient who never experienced expulsion of the gastric tablet. The MMC's were also clearly identifiable in several subjects. | As will be evident to an expert in the material, ! embodiments of the present invention can provide one the most advantages, such as: • The provision of a method and system for monitoring gastrointestinal motility that can be effectively used during the investigation of a pharmaceutical composition, and corresponding clinical trials, to better evaluate the research and clinical trials.

• The provision of a method and system to monitor the ! Gastrointestinal motility that has the potential to reduce the time and resources associated with the investigation of a pharmaceutical composition and clinical trials related to it. i · The provision of a method and system to monitor the function i i i gastrointestinal that can be easily used by a doctor as a diagnostic aid during the evaluations of gastrointestinal behavior. i Without departing from the spirit and scope of this invention, a person with ordinary knowledge can make various changes and modifications to the invention to adapt it to various uáos and I terms. As such, these changes and modifications; They are 1 properly, eq uitatively, and destined to be, within the i complete range of the equivalence of the following claims.

Claims (1)

1. REVIVAL DICTION ES i 1 . A system for monitoring the gastrointestinal function of a subject, comprising: i at least one mountable sensor close to a region of the body i of the subject, the sensor is adapted to detect acoustic energy and I generate at least one acoustic energy signal that represents the acoustic energy; and j j a processing unit adapted to receive the acoustic energy signal, the processing unit is further adapted to process the acoustic energy signal and determine the presence of at least one gastrointestinal parameter from the same. j 2. The system according to claim 1, wherein The gastrointestinal parameter comprises an event selected from the group consisting of mixing, emptying, contraction and gastrointestinal propulsion, and gastrointestinal transit time. j 3. The system according to claim 1, wherein the gastrointestinal parameter comprises an event associated with a gastrointestinal system disorder, the system disorder I Gastrointestinal is selected from the g rup consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and a disorder of the motor complex m tiigante, j ! 4. The system according to claim 1, wherein I The sensor generates a plurality of acoustic energy signals that represent the acoustic energy. ! 5. The system according to claim 4, wherein the processing unit is adapted to receive and process the Plurality of acoustic energy signals and determine the presence of I at least one first gastrointestinal parameter from the same. 6. The system according to claim 5, wherein the first gastrointestinal parameter comprises the gastrointestinal transit time i. · 7. A system for monitoring the gastrointestinal function of a subject, comprising: at least one mountable acoustic energy sensor next to i I a region of the body of the subject, the acoustic energy sensor ^ is adapted to detect the acoustic energy generated by the subject and i generate at least one acoustic energy signal representing the acoustic energy; ! At least one mountable spatial parameter sensor proximate a region of the subject's body, the spatial parameter sensor is adapted to monitor at least one spatial parameter associated with i the subject's body and generate at least one parameter signal i spatial that represents the spatial parameter; and j A processing unit adapted to receive the acoustic energy and spatial parameter signals, the processing unit is further adapted to determine the presence of at least one gastrointestinal parameter as a function of the acoustic energy signals and the spatial parameter. I 8. The system according to claim 7, wherein I the sensor of the spatial parameter comprises a motion sensor the sensor of the spatial parameter comprises an orientation sensor the gastrointestinal parameter comprises an event selected from Group consisting of mixing, emptying, contraction and propulsion I gastrointestinal, and gastrointestinal transit time. j 13. The system according to claim 7, wherein the gastrointestinal parameter comprises an event associated with a gastrointestinal system disorder, the gastrointestinal synatemium disorder is selected from the group consisting of reflux disease, gastrointestinal constipation, diarrhea, and a 14. A system pa physiological characteristics, At least one acoustic energy sensor mountable proximal to a region of the body of a subject, the acoustic energy sensor is adapted to detect the acoustic energy representing a gastrointestinal sound generated by the subject and generate at least a first acoustic energy signal representing acoustic energy; | 1 at least one mountable physiological sensor close to a branch I In the body of the subject, the physiological sensor is adapted to detect a physiological characteristic associated with the subject and generate at least a first signal of physiological characteristic that represents the i physiological characteristic; and j a processing unit adapted to receive the first of a gastrointestinal parameter from it. i The system according to claim 14, wherein the gastrointestinal parameter comprises an event selected from the group consisting of mixing, emptying, contraction and ! Gastrointestinal propulsion, and gastrointestinal transit time. | 16. The system according to claim 1, wherein the gastrointestinal parameter comprises an event associated with a gastrointestinal system disorder, the system disorder Gastrointestinal is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, and a motor-mitigating complex disorder. ! The system according to claim 14, wherein the physiological characteristic comprises a physiological characteristic selected from the group consisting of pulse rate, blood pressure, blood gas saturation, frequency respiratory, skin temperature, and electrical impulses associated with cardiac function. | 1 8. A system to monitor gastrointestinal function; and the physiological characteristics, which include: I At least one acoustic energy sensor mountable next to a body region of a subject, the acoustic energy sensor1 is adapted to detect the acoustic energy representing a gastrointestinal sound generated by the subject and generate at least a signal of acoustic energy that represents the acoustic energy; At least one mountable spatial parameter sensor next to a region of the body of the subject, the sensor of the spaced parameter is adapted to monitor at least one spatial parameter associated with the subject's body and generate at least one spatial parameter signal that represents the spatial parameter, j I At least one mountable physiological sensor proximate a region i of the body of the subject, the physiological sensor is adapted to detect a physiological characteristic associated with the subject and generate at least one signal of the physiological characteristic representing the physiological characteristic.; and | a processing unit adapted to receive the signals of acoustic energy, spatial parameter and physiological characteristic, the processing unit is further adapted to determine the presence of at least one gastrointestinal parameter such as | a function of acoustic energy signals and parameter space l. 1 9. The system according to claim 1 8, in where the sensor of the spatial parameter comprises a sensor i movement that is adapted to monitor the movement of the body i of the subject. 20. The system according to claim 19, wherein the spatial parameter comprises the movement of the body of the subject. ! I twenty-one . The system according to claim 1 8, wherein the sensor of the spatial parameter comprises an orientation sensor that is adapted to monitor the orientation of the body of the s where sujet where of the Gastrointestinal propulsion, and gastrointestinal transit time. j 24. The system according to claim 18, wherein the gastrointestinal parameter comprises an event associated with I a gastrointestinal system disorder, the gastrointestinal system disorder is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, and constipation, diarrhea, and a motor mitigating complex disorder. I 25. The system according to claim 18, wherein the physiological characteristic comprises a characteristic physiological selected from the group consisting of pulse rate, blood pressure, blood gas saturation, respiratory rate, skin temperature, and electrical impulses associated with the detection of acoustic energy. j i 28. The method according to claim 26, wherein i I the spatial parameter comprises the movement of the subject's body. 29. The method according to claim 26, wherein i the spatial parameter comprises the orientation of the subject's body. 30. The system according to claim 26, wherein the gastrointestinal parameter comprises an event selected from the group consisting of mixing, emptying, contraction and gastrointestinal propulsion, and gastrointestinal transit time. 31 The system according to claim 26, wherein the gastrointestinal parameter comprises an event associated with a disorder of the gastrointestinal system, the gastrointestinal synatemium disorder is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation , diarrhea, and a motor mitigating complex disorder. ' 32. A method to determine a gastrointestinal parameter í associated with a subject, comprising the steps of: detect the acoustic energy generated by the gastrointestinal system of the subject and generate an acoustic energy signal that represents the acoustic energy; J detecting at least one spatial parameter associated with the subject and generating a spatial parameter signal representing the j spatial parameter;; detecting at least one physiological characteristic associated with the subject and generating at least one signal of the physiological characteristic representing the physiological characteristic; Y; determine at least one gastrointestinal parameter as a function of the signals of acoustic energy and spatial parameter. I 33. The method according to claim 32, j further comprising using the signal of the spatial parameter to adjust the detection of the acoustic energy. ! I 34. The method according to claim 32, wherein The spatial parameter comprises the movement of the subject's body. 35. The method according to claim 32, wherein ! the spatial parameter understands the orientation of the subject's body. 36. The method according to claim 32, in d I onde I the gastrointestinal parameter comprises an event selected from j g rupo consisting of mixing, emptying, contraction gastrointestinal propu lsión, gastrointestinal transit time. 37. The method according to claim 32, wherein If the gastrointestinal parameter comprises an event associated with a disorder of the gastrointestinal system, the gastrointestinal system disorder is selected from the group consisting of reflux disease, irritable bowel disease, ulcerative colitis, constipation, diarrhea, motor complex disorder. m. 1 38. The method according to claim 32, wherein the physiological characteristic comprises a physiological characteristic selected from the group consisting of pulse rate, blood pressure, blood gas saturation, respiratory rate, skin temperature, and im pulses. associated with cardiac fusion. 39. A method to monitor gastrointestinal function the physiological characteristics of multiple subjects, which includes the steps of: detect the first acoustic energy generated by the system gastrointestinal tract of a first subject generate a first signal of I acoustic energy that represents the first acoustic energy; j ! detect a first physiological characteristic associated with the first subject; ! Item detect a second associated physiological characteristic cqn a second subject; determining at least one gastrointestinal parameter associated with the first subject as a function of the first acoustic signal. j 40. The method according to claim 39, wherein the second subject comprises a fetus of the first subject. RESU M IN I A system and method for evaluating gastrointestinal movement and, optionally, other physiological characteristics (e.g., pulse rate) that can be effectively employed are described. I to acquire one or more signals associated with the acoustic energy (i.e., the sound) emanating from an abdominal region of a body and to determine at least one parameter or gastrointestinal event based on acoustic energy signals. The gastrointestinal parameter may include a gastrointestinal event, including I mixing, emptying, contraction and gastrointestinal propulsion, and the gastrointestinal transit, including disease ulcerative colitis, constipation migratory engine.