WO2012104458A1

WO2012104458A1 - Apparatus and method for studying the relationship between gastroesophageal reflux and cardiorespiratory diseases

Info

Publication number: WO2012104458A1
Application number: PCT/ES2012/070049
Authority: WO
Inventors: José Antonio CABO VALDÉS; María José MOYA JIMÉNEZ; Manuel LÓPEZ ALONSO; Pablo CERRO SALIDO; María del Mar ELENA PÉREZ
Original assignee: Servicio Andaluz De Salud; Universidad De Sevilla
Priority date: 2011-01-31
Filing date: 2012-01-30
Publication date: 2012-08-09
Also published as: ES2419504R1; ES2419504B1; ES2419504A2

Abstract

The invention relates to an apparatus and a method for studying and diagnosing the involvement of gastroesophageal reflux (GER) in cardiorespiratory diseases, the involvement of cardiorespiratory diseases in GER, and the relationship therebetween. The apparatus and method are based on a plurality of probes for measuring gastroesophageal parameters and devices for measuring cardiorespiratory parameters, combined with different units for processing and displaying the data acquired, connected by means of an integrated communication system. The invention provides a reduced-size, highly versatile study tool that is suitable for use in intensive care units in medical centres.

Description

APPARATUS AND METHOD FOR THE STUDY OF THE RELATIONSHIP BETWEEN GASTROESOPHAGICAL REFLECTION AND CARDIOR-RESPIRATORY DISEASES FIELD OF THE INVENTION

The present invention refers to a device and a method for the measurement and analysis of gastroesophageal parameters and cardiorespiratory parameters of a patient, mainly oriented to the study of episodes of gastroesophageal reflux and the relationship of said episodes with cardiorespiratory diseases, as well as in the other sense the implication of these diseases in episodes of gastroesophageal reflux.

BACKGROUND OF THE INVENTION

In medicine, gastroesophageal reflux (GE) involves the reversal of the normal flow of food when swallowed. In the usual process of eating food or drink, these foods pass from the mouth to the throat (pharynx), then to the esophagus and then to the stomach. In the stomach, food is mixed with gastric juices, which among other elements, are composed of acid, which is necessary to digest proteins. The acid does not harm the stomach, because said organ secretes a mucous substance that protects it from the action of hydrochloric acid; However, this protective mucus is not produced by the esophagus, pharynx or mouth. If food and stomach acid return to the esophagus, it will cause irritation and burns, since the esophagus is not protected by the mucus. When the esophagus is constantly irritated by stomach acid, symptoms of gastroesophageal reflux occur: burning (heartburn), microaspirations (chronic cough), difficulty swallowing (dysphagia) due to impaired motility or stricture secondary to inflammation of the esophagus (esophagitis)

GER often occurs physiologically in preterm infants (premature birth) and in neonates (babies less than 28 days after birth), happening 1-2 times every 10 minutes. Both and others they need to drink a large amount of fluids and are continuously supine, which means that a gastroesophageal ion is permanently "underwater." In neonates, supraesophageal reflux is easier, because, proportionally, the esophagus is shorter than the volume in gastric co. The spontaneous transient sphincter relief, triggered by the distension of the stomach, caused in turn by the entry of food or the increase in abdominal pressure caused by the crying that alters the abdominal-thoracic gradient, causes stomach and esophagus to become in a unique physiological cavity that allows to accommodate this amount of liquid. The vast majority of reflux episodes reach the proximal esophagus.

When GER produces symptoms, we talk about gastroesophageal reflux disease (GERD). The symptomatology in preterm and neonates is completely different from the adult or the older child. GER has been associated with extradigestive problems, such as aspiration of gastric contents, both clinically and radiologically evident, or with episodes of apnea (cessation of the respiratory signal), bradycardia, (decrease in heart rate), desaturation (decrease the concentration of 0 ₂ in the blood) and chronic respiratory problems. In cases where an acute episode is triggered (accompanied by apnea), the reflex mechanism by which an apnea pause occurs after RGE is not clear, being explained in the state of the art in two ways: 1) Stimulation of receptors located in the larynx or nasopharynx by the exhaled acid material. 2) Stimulation of acid-sensitive receptors located in the esophagus. In infants, a decrease in respiratory effort, with or without bradycardia, is observed during intake, due to poor coordination between both functions. There is also oropharyngeal dysfunction in many of these children, who usually suffer from a cough crisis or cyanosis (bluish discoloration of the skin) during intake. In many cases, swallows are observed in the newborn that involve relaxation of the lower esophageal sphincter (LES) and, therefore, episodes of reflux, which correspond to apnea pauses. Most of the apnea crises observed occur in two situations: 1) With the patient awake, associated with intake or situations that cause increased intra-abdominal pressure.

2) During sleep, accompanied by stridor or cough. Apnea is accompanied by a variety of symptoms that include cyanosis, paleness, sweating or unusual movements.

Alternatively, the opposite situation can also occur, that is, that the apnea episode triggers the episode of GER due to an increase in the gastroesophageal pressure gradient caused by airway obstruction. There are studies that support both versions regarding the RGE-apnea episode relationship, but most of these studies have not been able to demonstrate this relationship in any decisive way.

Regarding patient care, today it is still necessary to establish objective criteria to identify those patients who require treatment for GERD. This has led to multiply medical and surgical anti-reflux treatments and hospital stays in intensive care areas (ICUs), with a significant increase in costs. These reasons have created, at present, a growing demand for tools that allow to study in detail the relationship between episodes of GER and other magnitudes, such as the cardiorespiratory conditions of the patient, which allow deepening in this field and determine, in the end , under what circumstances the episodes of GER occur, as well as to obtain the evidence that helps us determine the causes in which they occur, together with the effect that these episodes have on the patient's cardiorespiratory state.

Within the study of the implication of GER in cardiorespiratory diseases, of cardiorespiratory diseases in GER and its interrelation, the state of the art contemplates the existence of various devices, mainly used in research hospitals, where one or more more systems for studying the cardiorespiratory conditions of the patient, with one or more systems for measuring the conditions in which GER occurs, mainly by measuring of pH, together with impedance measurement techniques (measurement of the variable electrical resistance in the stomach and esophagus, depending on the amount of liquid present inside). Although the aforementioned devices share some elements with the present invention, they are not conceived as integral study tools of GERD, but more as combinations of isolated systems, which have to be adapted and modified in each type of study, which usually includes a non-negligible number of subsystems for the correct intercommunication and data acquisition of all device components. Such subsystems include, for example, the presence of signal digitization cards to accommodate them in a single final support, independent modules marketed by different companies for monitoring and subsequent processing of the data obtained, and the use of closed communication protocols between said components, which ultimately results in devices that have an excessive number of components (which, for example, in intensive care areas, where space is reduced, is a great inconvenience), or in devices with limited functionality in as for the treatment of the acquired data, as it does not have a "common language" of communication between components. The present invention is aimed at solving the aforementioned problems, by means of an integrated and small-sized apparatus for the study of the relationship between episodes of GER and cardiorespiratory diseases that co-re ndedi ve rs asunity are interconnected cooperators.

BRIEF DESCRIPTION OF THE INVENTION

An object of the present invention is an apparatus for the study of the implication of GER in cardiorespiratory diseases, of cardiorespiratory diseases in GER and of their interrelation, in a patient, comprising:

- one or more devices for measuring cardiorespiratory parameters of the patient; - a monitor for displaying the patient's cardiorespiratory parameters measured by the cardiorespiratory parameter measuring devices, the monitor being connected to said devices;

- one or more probes measuring the patient's gastroesophageal parameters;

- a unit of measurement, recording and storage of gastroesophageal parameters connected to the probes of measurement of gastroesophageal parameters;

- an integrated computing and visualization unit of the data acquired by the cardiorespiratory parameter measurement devices and by the gastroesophageal parameter measurement probes;

where the integrated computing and visualization unit also comprises a first communication system with the cardiorespiratory parameters display monitor by means of a communications protocol over a serial port; and a second communication system with the unit of measurement of gastroesophageal parameters by means of a communications protocol on a cable or wireless connection; and where said integrated computing and visualization unit is connected to the cardiorespiratory parameters display monitor and the gastroesophageal parameters measurement unit.

In a preferred embodiment of the invention, the patient's cardiorespiratory parameter measuring devices comprise one or more of the following: heart rate measuring device, respiratory rate measuring device, 0 ₂ saturation measuring device in the blood.

In a preferred embodiment of the invention the probes measuring the gastroesophageal parameters of the patient comprise a pH meter, and / or an impedance meter.

In a preferred embodiment of the invention the impedance meter comprises several metal rings that define the various impedance channels along the probe. In a preferred embodiment of the invention, the display monitor of the cardiorespiratory parameters of the patient is a digital monitor.

In a preferred embodiment of the invention the unit of measurement of gastroesophageal parameters is a unit of acquisition, process and digital data recording.

In a preferred embodiment of the invention, the integrated computing and visualization unit comprises a joint representation monitor of the gastroesophageal and cardiorespiratory parameters measured in the patient.

Among the main advantages provided by the apparatus of the present invention, the following can be mentioned:

- The invention describes an integrated system of components that allows the substantial reduction of the total size of the apparatus.

- The total integration of the components of the system also allows greater versatility in the analysis and visualization of the acquired data, which improves the conditions of the study of said data against the state-of-the-art devices.

Another object of the present invention is a method of obtaining useful data for the study of the involvement of RG E in cardiorespiratory diseases, cardiorespiratory diseases in GER and their interrelation, in a patient, comprising:

a) connect one or more devices for measuring cardiorespiratory parameters to a patient's body;

b) connect one or more probes measuring gastroesophageal parameters to a patient's body;

c) measure the cardiorespiratory and gastroesophageal parameters of the patient;

wherein, in said method, steps a), b) and c) are carried out by means of an apparatus according to claims 1-7 of this document. Another object of the present invention is a method of diagnosis of the involvement of GER in cardiorespiratory diseases, of cardiorespiratory diseases in GER and of their interrelation, in a patient, comprising:

d) record and analyze the cardiorespiratory parameters and the gastroesophageal parameters by means of an integrated computing and visualization unit of the data acquired by the cardiorespiratory parameter measurement devices and by the gastroesophageal parameter measurement probes, said computing and visualization unit being located outside the patient's body, and performing the analysis of the parameters recorded outside said body;

wherein, in said method, steps a), b), c) and d) are carried out by means of an apparatus according to claims 1-7 of this document.

Other features and advantages of the present invention will be apparent from the description of the invention that follows, as well as from the figure accompanying this document. DESCRIPTION OF THE FIGURES

Figure 1 shows a diagram of the apparatus of the invention, representing its main units. DETAILED DESCRIPTION OF THE INVENTION

As represented in Figure 1 of this document, the present invention comprises an apparatus for the study of the involvement of GER in cardiorespiratory diseases, of cardiorespiratory diseases in GER and its interrelation, in a patient, comprising the following elements:

- one or more devices for measuring cardiorespiratory parameters (1 - 3): They allow measuring the relevant parameters related to the cardiorespiratory activity of the patient to be monitored. Preferably, said devices comprise a heart rate measurement device (1), a respiratory rate measurement device (2), and / or a blood saturation measurement device of 0 ₂ (3).

- a display monitor (4): Allows visualization of the cardiorespiratory parameters of the patient in real time. Said monitor is connected to the cardiorespiratory measuring devices (1 -3) used, and allows the different measurement values to be shown both in isolation and as a whole. The monitor used to visualize the parameters can be any of the monitors usually used in a large part of the ICU areas of the hospital centers and distributed by companies such as Philips, Hewlett Packard or Sony, among others. In a preferred embodiment of the invention, the operating mode of the monitor used is digital, which allows a specialist to visualize, in real time, the measured parameter values, as well as process and send, in addition, the data captured to external equipment in a simple way, for later registration and analysis. - one or more probes measuring gastroesophageal parameters (5-6):

Preferably, the sondescomp re ndenunp H-meter (5) and / or an impedance meter (6), which allow the measurement of both the pH values and the impedance (electrical resistance) variable due to the presence of more or less liquid in the inside the esophagus and stomach of the patient. Preferably, the probes intended for pH measurement are arranged so as to analyze the content of the esophagus, stomach or both at the same time in the patient. Regarding the impedance measurement, the probes or catheters used have several metal rings that define the various impedance channels along the probe. Also, depending on the type of probe used, one or more pH sensors can be used.

- a unit of measurement of gastroesophageal parameters (7): This device is connected to the probes of measurement of gastroesophageal parameters (5-6), and allows both autonomous recording and storage of measured values. Like the display monitor (4), said gastroesophageal parameter measurement unit (7) operates, preferably, in digital mode, which allows access to the data being recorded by a cable or wireless connection, for example , via USB or bluetooth connections.

- an integrated computing and visualization unit (8): This unit, preferably a portable computer, receives and concentrates all the information obtained by means of the cardiorespiratory parameter measuring devices (1 -3) and the gastroesophageal probes (5-6) being the one in charge of collecting all the signals, storing them and representing them together. The computing unit (8) comprises a combination of hardware and software configured and programmed for the correct reception of the measured data, as well as for its analysis, and said data can also be represented, either in isolation (for each parameter) or together, on a monitor (9), preferably the monitor of a laptop. Within the hardware and software programmed and implemented in the computing unit (8), there is a first communication system with the display monitor (4) of the gastroesophageal parameters, preferably, by means of a communications protocol over a serial port. Thanks to this implementation, the numerical values of the parameters measured are obtained by means of the cardiorespiratory parameter measuring devices (1-3), for example, the heart rate, the respiratory rate and / or the oxygen saturation in the patient's blood. Additionally, the possibility of obtaining and recording, not only the values measured in isolation, but also the shape of its associated wave, also allows to represent the electrocardiogram, plethysmography and breathing patterns of the patient. On the other hand, the hardware and software implemented within the computing unit (8) It also includes a second communication system with the gastroesophageal parameter measurement unit (7), in charge of accessing said unit and acquiring the data measured by the gastroesophageal probes, preferably the pH meter (5) and the impedance meter (6). Said second communication system also comprises a communications protocol via cable or wireless connection, which allows the registration of gastroesophageal data directly in the computing unit (8), without the need to use additional devices or intermediate digitization cards, which considerably reduces the complexity of the total apparatus, also decreasing its size. In a preferred embodiment of the invention, the display of the gastroesophageal parameters comprises seven graphic signals, six of them corresponding to six impedance channels distributed in the impedance meter (6) and a last signal corresponding to the value measured by the pH meter (5). ) in the patient's stomach. All these signals can be represented, either as numerical values indicating the value of each variable at each moment, or as a graphic representation of them, thus showing their evolution over time, allowing the specialists in charge of the study to compare a value with its previous value in an easy and intuitive way.

The present invention makes it possible to visualize, in real time, the cardiorespiratory frequency, blood oxygen saturation and electrocardiography signals, adding to these data the impedance and pH signals, all representing on the monitor (9) of the unit of computation (8), obtaining a global and immediate representation of the parameters studied. Additionally, the apparatus described by the present invention can be exported in a simple way to any ICU unit that has a display monitor (a condition that, today, occurs in the vast majority of cases), which facilitates, Given its high level of integration in a single unit of analysis, the creation of networks for the study of patients in the different units. The present invention involves a simple and effective system that allows to identify all episodes of gastroesophageal reflux in preterm and neonates, assess whether they are acidic, weakly acidic or alkaline, see the height they reach and relate them to episodes of apnea desaturation or bradycardia that occur during registration, in order to know if these episodes are a cause or consequence of reflux and propose the appropriate treatment. This system considerably reduces the period of stay in the ICU, avoiding the use of inappropriate treatments and consequently reducing the morbomortality associated with this frequent pathology. The invention, in addition. It involves an optimization of the devices used in the state of the art, which combines the limitation of pediatric care spending to a large extent, with the substantial reduction of the total size of the device used. As described above, it is also another object of the present invention a method of obtaining useful data for the study of the implication of GER in cardiorespiratory diseases, of cardiorespiratory diseases in GER and of their interrelation, in a patient, which understands:

a) connect one or more devices for measuring cardiorespiratory parameters (1-3) to the body of a patient;

b) connect one or more probes measuring gastroesophageal parameters (5-6) to a patient's body;

wherein, in said method, steps a), b) and c) are performed by an apparatus according to any of the preceding embodiments described herein, and particularly reflected in claims 1-7. Finally, another method of the present invention is also a method of diagnosing the involvement of GER in cardiorespiratory diseases, cardiorespiratory diseases in GER and their interrelation, in a patient, comprising:

c) measure the cardiorespiratory and gastroesophageal parameters of the patient; d) record and analyze the cardiorespiratory parameters and gastroesophageal parameters by means of an integrated computing and visualization unit (8) of the data acquired by the cardiorespiratory parameter measurement devices (1 -3) and by the gastroesophageal parameter measurement probes ( 5-6), said integrated computing and visualization unit (8) being located outside the patient's body, and the analysis of the parameters recorded outside said body being performed;

wherein, in said method, steps a), b), c) and d) are carried out by means of an apparatus according to any of the preceding embodiments described herein, and particularly reflected in claims 1-7.

Once the present invention and some of its preferred embodiments have been described, it should be noted that said embodiments should not be considered as limiting in the face of variations in their design or in the combination of the elements that make up the apparatus, provided that said variations do not alter the essence of the invention, as well as the object thereof.

DESCRIPTION OF THE ELEMENTS OF THE FIGURES

Item Description

1 Heart rate measuring device

2 Measuring device respiratory rate

3 Device for measuring the saturation of 0 ₂ in the blood

4 Display monitor

5 pH meter, pH meter

6 Impedancemeter

7 Unit of measurement of gastroesophageal parameters

8 Integrated computing and visualization unit

9 Integrated computer unit representation monitor

Claims

1 .- Apparatus for the study of the implication of GER in cardiorespiratory diseases, of cardiorespiratory diseases in GER and its interrelation, in a patient, comprising:

- one or more devices for measuring cardiorespiratory parameters (1 - 3) of the patient;

- a display monitor (4) of the patient's cardiorespiratory parameters measured by the cardiorespiratory parameter measuring devices (1-3), the monitor being connected to said devices;

- one or more probes measuring the gastroesophageal parameters (5-6) of the patient;

- a unit of measurement, recording and storage of gastroesophageal parameters (7) connected to the probes of measurement of gastroesophageal parameters (5-6);

- an integrated computing and visualization unit (8) of the data acquired by the cardiorespiratory parameter measurement devices (1-3) and by the gastroesophageal parameter measurement probes (5-6);

said apparatus characterized in that the integrated computing and display unit (8) also comprises a first communication system with the display monitor (4) of the cardiorespiratory parameters by means of a communications protocol on a serial port; and a second communication system with the gastroesophageal parameter measurement unit (7) by means of a communications protocol over a cable or wireless connection; and wherein said integrated computing and visualization unit (8) is connected to the display monitor (4) of the cardiorespiratory parameters and to the gastroesophageal parameters measurement unit (7).

2. Apparatus according to claim 1, wherein the cardiorespiratory parameter measuring devices (1 -3) of the patient comprise one or more of the following: heart rate measurement device (1), respiratory rate measurement device ( 2), 0 ₂ saturation measuring device in the blood (3).

3. Apparatus according to any of claims 1-2, wherein the probes measuring the gastroesophageal parameters (5-6) of the patient comprise a pH meter (5) and / or an impedance meter (6).

4. Apparatus according to claim 3, wherein the impedance meter (6) comprises a plurality of metal rings defining the various impedance channels along the probe.

5. - Apparatus according to any of claims 1 -4, wherein the display monitor (4) of the cardiorespiratory parameters of the patient is a digital monitor.

6. - Apparatus according to any one of claims 1-5, wherein the unit of measurement of gastroesophageal parameters (7) is a unit of acquisition, process and digital data recording.

7. - Apparatus according to any of claims 1-6, wherein the integrated computing and visualization unit (8) comprises a monitor (9) of joint representation of the gastroesophageal and cardiorespiratory parameters measured in the patient.

8. - Method of obtaining useful data for the study of the implication of GER in cardiorespiratory diseases, of cardiorespiratory diseases in GER and of their interrelation, in a patient, comprising:

said method characterized in that steps a), b) and c) are carried out by means of an apparatus according to any one of claims 1-7.

9.- Method of diagnosis of the involvement of GER in cardiorespiratory diseases, of cardiorespiratory diseases in GER and its interrelation, in a patient, comprising:

d) record and analyze the cardiorespiratory parameters and gastroesophageal parameters by means of an integrated computing and visualization unit (8) of the data acquired by the cardiorespiratory parameter measuring devices (1 -3) and by the gastroesophageal parameter measurement probes ( 5-6), said integrated computing and visualization unit (8) being located outside the patient's body, and the analysis of the parameters recorded outside said body being performed;

said method characterized in that steps a), b), c) and d) are carried out by means of an apparatus according to any one of claims 1-7.