Energy wave deflection and method for detecting gastric distension and preventing aspiration - Patents.com

Abstract

The present disclosure addresses the troublesome pulmonary aspiration by proposing a non-invasive system and device that can detect gastric distension as a predictive "warning sign" of aspiration risk and a treatable risk factor to reduce the risk of highly morbid and often fatal aspiration events.

Description

[Technical field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 224,339, filed July 21, 2021, which is incorporated by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE Embodiments of the present disclosure relate to at least the fields of medicine, medical devices, and physiology. [Background technology]

[0003] Although commonly thought of as an anesthesia complication, pulmonary aspiration of gastric contents is one of the leading causes of morbidity and mortality in hospitalized patients. Aspiration occurs in as many as 30% of critically ill patients and can be identified as resulting in at least a 20% to 30% mortality rate in patients with aspiration pneumonia (1, 2). Mortality can exceed 70% in patients with aspiration pneumonia who have mortality risk factors (1, 2). Aspiration pneumonia can occur in nearly half of patients with aspiration events and is associated with prolonged ventilator support, intensive care unit length of stay, and hospital length of stay.

[0004] Aspiration is typically associated with gastric distension and impaired mental health, often due to hospital-related patient immobilization, sedation, or other risk factors for reduced consciousness and / or intestinal motility. Aspiration, defined as the entry of liquid or solid material into the trachea and lungs, occurs when a patient without an adequate protective laryngeal reflex passively or actively regurgitates gastric contents. In nearly all cases, increased gastric distension in patients with impaired consciousness leads to increased gastric pressure and regurgitation of gastric contents, which overcomes the normal protective functional barriers of the esophageal sphincter and laryngeal competency mechanisms, respectively. Regurgitation, vomiting, and aspiration can also occur quite out of the ordinary in association with anesthesia and can have serious consequences.

[0005] Pulmonary syndromes resulting from aspiration range from mild symptoms such as hypoxia to complete respiratory failure and acute respiratory distress syndrome (ARDS), and even cardiopulmonary collapse and death. Types of pulmonary syndromes include acid-associated pneumonia (most common), particle-associated aspiration (e.g., airway obstruction), or bacterial infection followed by lung abscess, exogenous lipoid pneumonia, chronic interstitial fibrosis, and Mycobacterium fortuitum pneumonia. The development of any of these syndromes depends on the composition and volume of the aspirate.

[0006] In either case, the key to minimizing the effects of aspiration is to prevent it from occurring. Mitigation of aspiration is usually based on exposing the patient to a sufficient period of fasting prior to a period of impaired consciousness, such as prior to anesthesia-induced reduction in consciousness. However, ensuring fasting is not applicable to patients in imminent or emergency situations requiring induction of anesthetic sedation.

[0007] Importantly, in addition to the occurrence of perioperative aspiration, an even more perplexing challenge is that of aspiration occurring in hospitalized patients who have become desensitized and / or do not otherwise have normally functioning GI activity. In such situations, fasting for extended periods is neither desirable nor feasible in hospitalized patients, as it would cause malnutrition. In such patients, confirmation and maintenance of normal gastrointestinal function and gastric emptying are important considerations in preventing aspiration.

[0008] An example of a patient at risk for aspiration is one with sepsis and intestinal hypomotility with some degree of decreased consciousness (intrinsic or medically induced), or a postoperative patient with a similar disorder. In this context, the preventive measures presented below may be relevant in the immediate perioperative period, when more intensive emergency monitoring, evaluation, and intervention are feasible, but such measures are not conducive to aspiration treatment for the latter category of patients, where prolonged (days long) monitoring is required.

[0009] Preemptive nasogastric (NG) tube placement has been proposed as an option for aspiration risk reduction in patients at risk. However, evidence supporting this as a common practice is lacking. Furthermore, nasogastric tube placement in its current form does have an inherent risk of inducing vomiting, which may counterintuitively increase aspiration risk. Furthermore, long-term NG tube placement is a known risk factor for hospitalized patient morbidity. Therefore, NG tube placement without appropriate indications (such as evidence of gastric distension) is not recommended.

[0010] Histamine (H2) antagonists such as cimetidine, famotidine, nizatidine, and ranitidine, and proton pump inhibitors (PPIs) such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole have been shown to be effective in increasing pH and decreasing the volume of gastric contents. Prokinetics such as domperidone, metoclopramide, erythromycin, and renzapride should enhance gastric emptying and reduce the risk of aspiration. The effectiveness of using such agents to prevent the sequelae of aspiration has similarly not been demonstrated. Summary of the Invention [Problem to be solved by the invention]

[0011] The present disclosure satisfies a long felt need in the industry relating to reducing the likelihood of pulmonary aspiration in patients at risk for aspiration. [Means for solving the problem]

[0012] The embodiments of the present disclosure relate to methods and systems for measuring stomach dimensions and utilizing such dimensions to reduce the risk of pulmonary aspiration in individuals at risk for pulmonary aspiration. The system may comprise at least one energy generator and at least one energy detector. The energy generator may generate wave energy, including acoustic, mechanical, and / or electromagnetic waves. The energy detector may detect the energy generated by the energy generator. In some embodiments, the energy detector comprises a specific array of energy detectors. The array of energy detectors may be a one-dimensional array or a two-dimensional array. In some embodiments, the system comprises two, three, four, five or more energy detectors. In some embodiments, the system comprises a mounting structure. The mounting structure may comprise a structure for mounting the energy detector and / or the energy generator. The mounting structure may comprise a means for fastening the mounting structure to the individual. In some embodiments, the mounting structure comprises a means for fastening the mounting structure to the skin of the individual. The mounting structure may comprise any type of adhesive, so long as the adhesive is not permanent.

[0013] Systems encompassed herein, and methods of using such systems, may include a computing device. The computing device may be capable of processing data detected by any of the energy detectors disclosed herein. The computing device may generate stomach dimensions from the data detected by the energy detector.

[0014] Certain embodiments relate to a method for reducing the risk of pulmonary aspiration in an individual. Certain embodiments relate to a method for detecting gastric distension in an individual. In some embodiments, the method comprises placing any system encompassed herein on the individual at a suitable location, generating energy on the individual with an energy generator, and detecting the energy with an array of energy detectors on the individual. The detecting step may generate refraction data in specific embodiments. In some embodiments, the method includes generating at least one source wave on the individual and detecting direct, reflected, and refracted waves from the source wave at one or more defined locations on the individual, and the detecting step generates refraction data. The energy generator and / or energy detector may be placed on the abdominal surface of the individual. The abdominal surface may be on the posterior, lateral, or anterior side of the individual. When there are multiple energy detectors, the array for the energy detectors may be random or non-random. The detectors may be placed on the individual in a random or ordered pattern. In some embodiments, the pattern is, by way of example only, a line, a triangle, a square, a circle, a diamond, a pentagon, a trapezoid, or a hexagon.

[0015] In some embodiments, the method includes processing the refraction data to determine a stomach dimension of the individual. The individual may be administered at least one preventive and / or therapeutic intervention, including when the stomach dimension reaches or exceeds a threshold value indicative of a risk of pulmonary aspiration or gastric distension. In alternative cases, no action may be taken. In some embodiments, the preventive and / or therapeutic intervention is administered to the individual when the stomach dimension includes a gastric silhouette value greater than about 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, or 20 cm or greater. In some embodiments, the preventive and / or therapeutic intervention is administered to the individual when the stomach dimension includes a gastric silhouette value greater than about 500 cm. 3 , 510cm 3 , 525cm 3 , 550cm3 , 575cm 3 , 600cm 3 , 625cm 3 , 650cm 3 , 675cm 3 , 700cm 3 or greater (Delgado-Aros et al., Gastroenterology 2004;126:432-440; Delgado-Aros et al., Gastroenterology 2004;127:1685-1694). In some embodiments, prophylactic and / or therapeutic intervention is administered to an individual when the gastric dimensions increase by 100% from the baseline measurements in the individual (Delgado-Aros et al., Gastroenterology 2004;126:432-440; Delgado-Aros et al., Gastroenterology 2004;127:1685-1694).

[0016] In some embodiments, the individual is administered preventive and / or therapeutic interventions. The preventive and / or therapeutic interventions may include discontinuation of sedation, modification of the individual's positioning, placement of a nasogastric tube, histaminergic drugs, proton pump inhibitors, prokinetic drugs, or combinations thereof. The histaminergic drugs may include cimetidine, famotidine, nizatidine, ranitidine, or combinations thereof. The proton pump inhibitors may include dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, or combinations thereof. The prokinetic drugs may include domperidone, metoclopramide, erythromycin, renzapride, or combinations thereof.

[0017] Certain embodiments include detecting, diagnosing, treating, and / or monitoring the individual, including detecting gastric distension and detecting risk of pulmonary aspiration. In some embodiments, the fasting state and / or gastric contents of the individual are unknown. In some embodiments, the individual has or is suspected of having delayed gastric emptying. Delayed gastric emptying may be caused by diabetic gastroparesis, progressive liver dysfunction, and / or progressive renal dysfunction. In some embodiments, the individual is critically ill. In some embodiments, the individual has an unreliable or uncertain medical history. In some cases, the individual has been non-compliant with instructions to maintain a fasting state.

[0018] It is contemplated that any embodiment described herein can be implemented with respect to any method, composition, and / or system of the present disclosure, and vice versa. Further, the compositions and systems of the present disclosure can be used to achieve the methods of the present disclosure.

[0019] Other objects, features, and advantages of the present disclosure will become apparent from the following detailed description. It should be understood, however, that the detailed description and specific examples, while indicating specific embodiments of the present disclosure, are given by way of illustration only, since various changes and modifications within the spirit and scope of the present disclosure will become apparent to those skilled in the art from this detailed description.

[0020] The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present disclosure. The present disclosure may be better understood by reference to the drawings in combination with the detailed description of specific embodiments presented herein. [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 shows an embodiment of an array of receivers (shown as smaller dark circles by way of example only) placed on an individual, and an acoustic generator (single larger circle) (or alternative energy generator including a mechanical energy generator). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] definition Throughout this application, the term "about" is used to indicate that a value includes the inherent variation of error for any measuring or quantitating method.

[0023] The use of the word "a" or "an" when used in conjunction with the term "comprising" can mean "one," but it is also consistent with the meaning of "one or more," "at least one," and "one or more than one."

[0024] The term "and / or" means "and" or "or." As an example, A, B, and / or C includes A alone, B alone, C alone, A and B in combination, A and C in combination, B and C in combination, or A, B, and C in combination. In other words, "and / or" operates as an inclusive or.

[0025] The words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include"), or "containing" (and any form of containing, such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0026] The compositions and methods for their use may "comprise," "consist essentially of," or "consist of" any of the components or steps disclosed throughout this specification. Compositions and methods "consisting essentially of" any of the disclosed components or steps limit the claims to particular materials or steps that do not materially affect the basic and novel characteristics of the claimed disclosure.

[0027] The term "gastric dimension" as used herein may refer to any size, length, width, diameter, radius, circumference, area, volume, capacity, ratio, or measurement of an individual's gastrointestinal tract or any organ of the gastrointestinal tract, including the stomach.

[0028] The term "stomach silhouette" may refer to the maximum, minimum, or average length, diameter, radius, or circumference of an individual's abdomen.

[0029] Reference throughout this specification to "one embodiment," "an embodiment," "a particular embodiment," "a related embodiment," "a certain embodiment," "an additional embodiment," or "a further embodiment," or combinations thereof, means that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the disclosure. Thus, appearances of such phrases in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0030] Various aspects of the present disclosure may be presented in range format. It should be understood that the description in range format is merely for convenience and brevity, and should not be interpreted as an inflexible limitation on the scope of the present disclosure. Thus, the description of a range should be considered as having all possible subranges specifically disclosed, and individual numerical values ​​within that range, as if they were explicitly written out. For example, a description of a range such as 1 to 6 should be considered as having specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and individual numerical values ​​within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. When a range exists, this range may include the end points of the range.

[0031] The term "individual" as used herein may be used interchangeably with the term "patient" in some embodiments and generally refers to an individual in need of treatment. The individual may be a mammal, such as a human, dog, cat, horse, pig, or rodent. The individual may be a patient, e.g., a patient having a disease or condition, or suspected of having a disease or condition, or at risk of having a disease or condition. The individual may have a disease, or may be suspected of having a disease. The individual may be asymptomatic.

[0032] Acoustic Refraction (AR) method Acoustic waves are mechanical perturbations that travel at a speed dictated by the acoustic impedance of the medium through which they pass. When an acoustic wave approaches an interface between two materials with different acoustic impedances, part of the wave energy is reflected at the interface and part is refracted through the interface. An array of acoustic receivers may be used to measure the time it takes for the wave to return to the surface. The travel times from the source to the various receivers and the speed of the acoustic wave can then be used to reconstruct the interface of the near-surface part (tissue) using mathematical modeling techniques including the generalized reciprocity method (GRM) based on Snell's law of refraction (3), thereby delineating the (stomach) volume enclosed by the contoured acoustic interface.

[0033] Certain embodiments of the present disclosure encompass methods that include the generation and detection of energy in an individual. In some embodiments, the energy includes waves. The waves can be mechanical waves, such as sound waves. In some embodiments, the energy is electromagnetic energy. Any type of energy that generates refractible waves can be used. Waves of any frequency can be used, including radio and / or ultrasonic frequencies. In some embodiments, one or more energy generators are used. In some embodiments, the waves travel from the energy generator through the individual. The waves can be refracted at tissue interfaces. In some embodiments, the direct waves (i.e., non-refracted waves) and refracted waves are detected by one or more detectors. The detectors can include an array of detectors. The array of detectors can be a one-dimensional array or a two-dimensional array. The detectors can be arranged in any geometric pattern, such as a line (including a straight line), a triangle, a square, a circle, a diamond, a pentagon, a trapezoid, or a hexagon. In some embodiments, there are 2, 3, 4, 5, 6, 7, 8, 9, 10, or more detectors. The detector may be any suitable device capable of detecting the energy generated by the energy generator, such as an acoustic detector. The acoustic detector may be a microphone. In certain embodiments, the refraction data is generated by measuring the time that each acoustic detector detects the wave after the energy generator generates the wave.

[0034] Certain embodiments include methods for processing data, including refraction data, generated by the detection methods described herein. Any method capable of processing data may be used. In some embodiments, mathematical methods are used. In some embodiments, a mathematical model compares the expected detection time with the actual detection time (i.e., the time at which each detector detects the wave generated by the energy generator). The mathematical method may include a generalized reciprocity method. The mathematical model may incorporate wave frequency, tissue specific velocity, critical refraction angle, and other variables necessary to establish one or more stomach dimensions. The mathematical method may include refractor velocity analysis and / or time-depth calculations.

[0035] Compared to commonly used ultrasound medical techniques that use one sensor and one receiver unit that must be manually operated by a skilled operator, the systems and methods encompassed herein can employ multiple spatially distant receivers (i.e., over a relatively large body surface area) that in combination can continuously collect data to map a two-dimensional or three-dimensional model, such as the abdomen. Importantly, in contrast to ultrasound, the AR receivers used herein may be pre-positioned at defined locations to monitor a target image (e.g., the stomach to assess gastric distension, a risk marker for aspiration), and thus may not require a skilled operator to position, manipulate, or analyze the receiver-derived data. In some embodiments, refraction data is acquired simultaneously over any given area with any desired geometry. The refraction data can then be displayed graphically and subjected to computations without user input, facilitating and automating the analysis. In some embodiments, this capability allows for automatic, user-independent signaling of abnormal gastric distension conditions, essentially a risk signal for gastric aspiration. This signaling can trigger medical personnel to implement preventive anti-aspiration actions such as positioning correction, discontinuation of sedation, or NG tube placement. In addition to the beneficial ease and applicability of this approach, a uniform receiver location for assessing stomach size can be determined generically for all patients as determined by one of skill in the art, again eliminating the need for user-specific knowledge issues or patient-specific receiver placement. In certain cases, the device may be placed without the need for a specifically predefined location.

[0036] Compared to the AR methods disclosed herein, ultrasound data acquisition, imaging, and analysis are highly dependent on the user having knowledge of the anatomy and are limited by the depth of ultrasound penetration. For example, to map a three-dimensional space such as the stomach, the ultrasound scanner must be swept across the upper abdomen in a careful manner to acquire images of the stomach. This requirement requires user knowledge of the anatomy of the target (stomach) structure, as well as the surrounding anatomy. Ultrasound-based imaging is also limited by air-filled and bony structures that limit sufficient data acquisition. The process by which ultrasound probing is performed is still cumbersome in that the manual imaging process must be frequently repeated, each time a new set of potentially inconsistent images must be acquired by a trained technician or physician.

[0037] Some aspects of the present disclosure relate to the application of AR technology that is useful as a routine, low-cost methodology for assessing aspiration risk (including on a continuous basis) in essentially all clinical situations where aspiration risk is prolonged, uncertain, or undetermined, such as in hospitalized patients. In some embodiments, stomach dimensions are measured continuously, measured at specific time periods, and / or measured when the individual arrives for treatment. Any such measurement interval may establish a solid baseline measurement. Three specific additional clinical scenarios for AR use are: 1) pre-operative patients who are not following fasting guidelines due to communication gaps, non-compliance, or due to the urgency of the clinical situation, 2) patients with delayed gastric emptying due to significant comorbidities where it may be uncertain that the recommended fasting interval will guarantee an empty stomach (e.g., diabetic gastroparesis, progressive hepatic or renal insufficiency, critically ill patients), and 3) patients with unreliable or unknown histories (e.g., language barriers, cognitive impairment, paresthesia). The AR technology encompassed herein can help clinicians minimize or eliminate the risk of aspiration in all such cases.

[0038] System for detecting stomach volume - Patents.com Certain embodiments encompass a system for detecting stomach volume. The system may be capable of performing any of the methods disclosed herein. In certain embodiments, the system generates mechanical or electromagnetic waves using an energy generator. The energy generator may include any device capable of generating mechanical or electromagnetic waves. In some embodiments, the energy generator generates an impact force. In some embodiments, the energy generator comprises a speaker. The energy generator may generate waves at any frequency, including radio frequencies.

[0039] In certain embodiments, the system detects waves generated by the energy generator. In some embodiments, the system comprises one or more detectors. The detector can comprise an array of detectors. The array of detectors can be a one-dimensional array or a two-dimensional array. The detectors can be arranged in a geometric pattern, such as a line (including a straight line), a triangle, a square, a circle, a diamond, a pentagon, a trapezoid, or a hexagon. The detector can include any device capable of detecting energy, including wave energy. The detector can include any device capable of detecting energy generated by the energy generator. In some embodiments, the detector comprises a microphone. The detector itself may be of any shape and size. The detector can be placed on the abdomen of the individual, such as below the diaphragm but above the pelvis. In some cases, the detector may be placed on the back, but corresponding to the abdominal area on the front. In specific embodiments where a three-dimensional output is desired, one or more detectors may be placed on the front of the individual and on the back of the individual.

[0040] In some embodiments, the system comprises a mounting structure for holding the energy generator and the detector. The mounting structure may comprise any suitable material for holding the energy generator and the detector, such as plastic, metal, fabric, tape, or combinations thereof. In certain embodiments, the mounting structure comprises a means for fastening the mounting structure to the individual. The mounting structure may comprise a tape, strap, clip, belt, hook, or other structure capable of fastening the mounting structure to the individual. In some embodiments, the mounting structure comprises a means for fastening the mounting structure to the skin of the individual. The mounting structure may be capable of being fastened to the abdomen and / or back of the individual.

[0041] In some embodiments, the system includes a computing device for processing data detected by the energy detector, the computing device may use any method, including any mathematical method described herein, to calculate or generate stomach dimensions.

[0042] Referring to FIG. 1, the system 100 comprises (one or) multiple detectors 110 and an energy generator 120 at either an anterior location 101 of the individual or a posterior location 102 of the individual. Data is collected from the detectors 110 on the individual at the anterior location 101 or posterior location 102 of the individual and uploaded to a telemetry-based local receiver 130, as appropriate, or to an encrypted cloud-based server that analyzes the data as sample analysis output 140 by a simple computational algorithm based on GRM calculations or an artificial intelligence / neural network system. The algorithm is used to determine gastric distension based on acoustic refraction topographic modeling. A simple display readout 150, such as a screen, provides the end user with a message indicating a "safe" or "unsafe" recommendation regarding the gastric risk assessment. In some cases, the readout is electronically transferred to a remote receiver, such as a cell phone or tablet or computer. That is, in some cases, the receiver / computer may be embedded in a patient-based device and the readout may be sent remotely to signal an alarm.

[0043] Individuals at risk for pulmonary aspiration Certain embodiments include detecting stomach distension of an individual, reducing the risk of pulmonary aspiration, and / or detecting stomach dimensions. In some embodiments, an individual is in need of emergency treatment, which may result in the individual's stomach contents being unknown. Other circumstances and circumstances, such as language barriers, mental incapacity, and / or refusal to communicate, may also be reasons why an individual's stomach contents are unknown.

[0044] The methods and systems disclosed herein may be used to determine the stomach contents of any individual, including individuals who are intubated, anesthetized, unconscious, and / or asleep, or soon to be. In some embodiments, the individual is fasting or not fasting. The systems and methods disclosed herein may be used to determine whether an individual has fasted or not. In some embodiments, the individual has delayed gastric emptying or is suspected of having delayed gastric emptying. Delayed gastric emptying may be caused by various illnesses, syndromes, or diseases, such as diabetic gastroparesis, progressive liver dysfunction, and / or progressive renal dysfunction. In certain embodiments, the individual is severe or has an unreliable or uncertain medical history. The systems and methods disclosed herein may reduce the risk of placing an individual under anesthesia by measuring the dimensions of the individual's stomach and determining the individual's risk of pulmonary aspiration.

[0045] Certain embodiments encompass methods and systems for measuring one or more stomach dimensions in an individual. The measured stomach dimensions may be used to determine if an individual is at risk for pulmonary aspiration. Several thresholds may be used to determine if an individual is at risk for pulmonary aspiration and / or has gastric distension. In some embodiments, the thresholds include lengths of 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, 20 cm or more. The length may be the maximum, minimum, or average length of an organ in the gastrointestinal tract, such as the stomach. In some embodiments, the threshold is about 20 cm. 3 , 21cm 3 , 22cm 3 , 23cm 3 , 24cm 3 , 25cm 3 , 26cm 3 , 27cm 3 , 28cm 3 , 29cm 3 , 30cm 3 , 31cm3 、32cm 3 、33cm 3 、34cm 3 、35cm 3 、36cm 3 、37cm 3 、38cm 3 、39cm 3 、40cm 3 、41cm 3 、42cm 3 、43cm 3 、44cm 3 、45cm 3 、46cm 3 、47cm 3 、48cm 3 、49cm 3 、50cm 3 、55cm 3 、60cm 3 、65cm 3 、70cm 3 、75cm 3 、80cm 3 、85cm 3 、90cm 3 、95cm 3 、100cm 3 、110cm 3 、115cm 3 、120cm 3 、125cm 3 、130cm 3 、135cm 3 、140cm 3 、145cm 3 、150cm 3 、155cm 3 、160cm 3 、170cm 3 、175cm 3 、180cm 3 、185cm 3 、190cm 3 、195cm 3 、200cm 3 、210cm 3 、220cm 3 、230cm 3 、240cm 3 、250cm 3 、260cm 3 、270cm3 、280cm 3 、290cm 3 、300cm 3 、325cm 3 、350cm 3 、375cm 3 、400cm 3 、425cm 3 、450cm 3 、475cm 3 、500cm 3 、525cm 3 、550cm 3 、575cm 3 、600cm 3 、625cm 3 、650cm 3 、675cm 3 、700cm 3 、725cm 3 、750cm 3 、775cm 3 、800cm 3 、825cm 3 、850cm 3 、875cm 3 、900cm 3 、925cm 3 、950cm 3 、975cm 3 、1000cm 3 、1100cm 3 、1200cm 3 、1300cm 3 、1400cm 3 、1500cm 3In some embodiments, the threshold includes an increase in at least one stomach dimension from a previous measurement or from a known baseline, the increase being about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 100%, 125%, 150%, 175%, 200%, 225%, 250%, 275%, 300%, 325%, 350%, 375%, 400%, 400%, 45 ... The baseline may be 25%, 450%, 475%, 500%, 600%, 700%, 800%, 900%, 1000%, 1250%, 1500%, 1750%, 2000%, 2250%, 2500%, 2750%, 3000%, 3250%, 3500%, 3750%, 4000%, 4250%, 4500%, 4750%, 5000%, 6000%, 7000%, 8000%, 9000% or more. An individual's baseline may be determined by measuring stomach dimensions when the individual has known stomach contents or a known fasting state. A baseline may be determined by measuring stomach dimensions one or more times. A baseline may be determined by continuously measuring stomach dimensions. In certain embodiments, the system allows the operator the ability to "dial in" any threshold setting (i.e., any desired diameter or volume at any value). EXAMPLES

[0046] The following examples are included to demonstrate certain embodiments of the present disclosure. It should be understood by those skilled in the art that the techniques disclosed in the following examples represent techniques that the inventors have discovered to work well in implementing the embodiments of the present disclosure, and therefore can be considered to constitute specific modes for its implementation. However, those skilled in the art should understand in light of the present disclosure that many changes can be made in the specific embodiments disclosed and still obtain the same or similar results without departing from the spirit and scope of the present disclosure.

[0047] I. Example I: Solution for preventive detection of risk of gastric dilation and aspiration In one embodiment, the AR stomach imaging technique comprises an array of acoustic receivers attached to the patient's skin covering the patient's stomach, and a mechanical and / or acoustic generator positioned at the center of the receiver. The receiver detects different arrival times of acoustic energy waves generated by the generator at different spatially separated reception points (FIG. 1). The array may or may not be attached to the patient's abdomen with medical adhesive or tape intermittently (e.g., every 8-hour shift change) or for extended periods to allow more frequent imaging analysis.

[0048] In one embodiment, the AR generator-receiver system transmits the signal arrival times to an AR analysis computer that uses algorithms such as GRM calculations to calculate stomach diameter. This computational element of the device may in certain embodiments be intrinsic to the device itself or may be connected by radio frequency or other telemetry methodologies, including, for example, a cell phone, remote telemetry cloud-based artificial intelligence / neural network, or other suitable devices. The final output of this array may be as simple as a traffic light: red indicates a full stomach (above standard stomach silhouette values) and thus warrants further evaluation or intervention, green indicates an empty stomach (within standard stomach silhouette values) and no further steps are indicated, and yellow indicates intermediate values ​​and actions (these values ​​may be predetermined based on prospective studies and / or set by individual providers or institutions).

[0049] All of the methods disclosed and claimed herein can be made and performed in light of the present disclosure without undue experimentation. Although the compositions and methods of the present disclosure have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that modifications may be applied to the methods described herein and to the steps or sequence of steps of the methods without departing from the concept, spirit and scope of the present disclosure. More specifically, it is apparent that certain agents that are both chemically and physiologically related may be substituted for the agents described herein while still achieving the same or similar results. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the present disclosure as defined by the appended claims. References The following references, to the extent that they provide exemplary procedural or other details supplementary to those set forth herein, are specifically incorporated herein by reference.

[0050] (1)Norma A. Metheny, PhD, Ray E. Clouse, MD, Yie-Hwa Chang, PhD, Barbara J. Stewart, PhD, Dana A. Oliver, MPH, and Marin H. Kollef, MD Tracheobronchial aspiration of gastric contents in critically ill tube-fed patients: frequency, outcomes, and risk factors.Crit Care Med.2006;34:1007~1015.

[0051] (2)Lanspa MJ;Jones BE;Brown SM;Dean N. Mortality, morbidity, and disease severity of patients with aspiration pneumonia.J Hosp Med.2013;8:83~90.

[0052] (3)Robert W. Lankston. The seismic refraction method: A viable tool for mapping shallow targets into the 1990s. Geophysics. 1989; 54: 1521 - 1663.

Claims

1. A system for detecting gastric volume, comprising an energy generator and at least one energy detector, configured to detect the gastric volume of an individual.

2. The energy generator generates a mechanical wave, an electromagnetic wave, or a matter wave, or a plurality of energy generators generate a combination of a mechanical wave, an electromagnetic wave, and a matter wave, and the energy detector detects the wave generated by the energy generator. The system according to claim 1.

3. The system according to claim 1, further comprising at least one attachment structure, wherein an array of energy detectors, the energy generator, or both are attached to the attachment structure.

4. The system according to claim 3, wherein the attachment structure comprises means for attaching the attachment structure to an individual.

5. The system according to claim 4, wherein the attachment structure comprises means for fixing the attachment structure to the skin of the individual.

6. The system according to claim 1, wherein the array of energy detectors comprises two, three, four, five or more energy detectors.

7. The system according to claim 1, wherein the energy detectors are physically separate from each other.

8. The system according to claim 1, further comprising a computing device configured to process data detected by the energy detector and generate gastric dimensions.

9. The array of energy detectors is a one-dimensional array or a two-dimensional array, and the one-dimensional array or two-dimensional array of energy detectors is configured in a random pattern, an ordered pattern, or a desired pattern. The system according to claim 1.

10. A method of operating a system for detecting the risk of pulmonary aspiration in an individual, comprising: a) operating the system according to claim 1 while disposed on the abdomen of the individual; b) generating energy in the abdomen of the individual using the energy generator; and c) detecting the energy from the energy generator using an array of energy detectors, the detecting step generating direct data, reflected data, and refracted data.

11. The method of claim 10, further comprising processing the direct data, the reflected data, and the refracted data to determine the dimensions of the stomach of the individual.

12. The method of claim 10, wherein when the dimensions of the stomach reach or exceed a threshold indicating the risk of pulmonary aspiration, the computing device further comprises generating information indicating that a prophylactic intervention and / or a therapeutic intervention can be performed on the individual.

13. When the dimensions of the stomach include a gastric silhouette value greater than 5 cm or greater than 10 cm, When the dimensions of the stomach include a gastric volume greater than 200 cm3, 250 cm3, or 500 cm3, or The method of claim 12, wherein when the dimensions of the stomach increase by 100% from a baseline measurement in the individual, the computing device further comprises generating information indicating that a prophylactic intervention and / or a therapeutic intervention can be performed on the individual.

14. The method of claim 10, wherein the prophylactic intervention and / or the therapeutic intervention includes discontinuation of sedation, repositioning of the individual, placement of a nasogastric tube, a histamine agonist, a proton pump inhibitor, a motility agent, or a combination thereof.

15. The histamine agonist includes cimetidine, famotidine, nizatidine, ranitidine, or a combination thereof, The proton pump inhibitor includes dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, or a combination thereof, or The method of claim 14, wherein the motility agent includes domperidone, metoclopramide, erythromycin, renzapride, or a combination thereof.

16. The method of claim 10, further comprising operating with the energy detector disposed on the abdominal surface of the individual, wherein the detector is disposed on the abdominal surface of the individual in a random pattern, an ordered pattern, or a desired pattern.

17. The method of claim 10, wherein the abdominal surface includes the skin of the individual or the clothing of the individual.

18. The method of claim 10, wherein the abdominal surface is on the posterior or anterior side of the individual.

19. The method according to claim 10, wherein the ordered pattern, or the desired pattern, is a straight line, a triangle, a square, a circle, a rhombus, a pentagon, a trapezoid, or a hexagon.

20. The method according to claim 10, wherein the fasting state and / or gastric contents of the individual are unknown.

21. The method according to claim 10, wherein the individual has, or is suspected of having, delayed gastric emptying.

22. The method according to claim 21, wherein the delayed gastric emptying is caused by diabetic gastroparesis, progressive liver dysfunction, progressive kidney dysfunction, drug therapy, sepsis, inflammation, peritonitis, electrolyte abnormalities, and / or narcotics.

23. The method according to claim 10, wherein the individual is critically ill, has an unreliable or uncertain medical history, or was non-compliant.

24. The method according to claim 10, wherein steps b and c are continuous.

25. A method of operating a system for detecting the risk of pulmonary aspiration in an individual, the method comprising generating at least one source wave in the individual and detecting direct waves, reflected waves, and refracted waves from the source wave at one or more defined positions on the individual, the detecting step generating direct data, reflected data, and refracted data.

26. A method of detecting gastric distension, the method comprising generating at least one source wave in the individual and detecting direct waves, reflected waves, and refracted waves from the source wave at one or more defined positions on the individual, the detecting step generating direct data, reflected data, and refracted data.

27. The method according to claim 11, wherein the data is processed by an artificial intelligence or neural network system.

28. A wearable system for detecting gastric distension, comprising one or more energy generators and ten or more energy detectors, configured to detect the dimensions or gastric silhouette of an individual.

29. The wearable system according to claim 28, wherein the energy generator generates ultrasonic waves.

30. The wearable system according to claim 28, further comprising an attachment structure for holding the energy generator and the detector. **Claim 31**: A wearable system according to claim 30, wherein the attachment structure includes an adhesive for fixing the attachment structure to an individual's skin. **Claim 32**: A wearable system according to claim 28, wherein the energy detector and the energy generator are arranged in an ordered pattern including a straight line. **Claim 33**: A wearable system according to claim 28, wherein the energy detector detects direct waves, reflected waves, and refracted waves. **Claim 34**: A wearable system according to claim 28, wherein the energy detector measures the time until a wave returns to the system to generate tissue interface data. **Claim 35**: A wearable system according to claim 28, wherein the dimensions of the stomach include any size, length, width, diameter, radius, circumference, area, volume, capacity, ratio, or measurement of an individual's stomach, and the silhouette of the stomach includes the average length, diameter, radius, or circumference of an individual's abdomen.

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