CN204181609U - Manometry device and manometry system for determining the function of a hollow organ - Google Patents

Abstract

The utility model discloses a pressure measurement equipment and pressure measurement system for confirming cavity organ function, this equipment includes: an elongated body, and a plurality of electrodes disposed on the elongated body; and one or more devices for applying stimulation to the internal organs, including dilation balloon, thermal, chemical or electrical stimulation devices, electrodes inside the balloon can measure electrical resistance, and these resistance values can be scaled to the internal diameter of the balloon at different locations. Adopt the technical scheme of the utility model can realize collecting simultaneously high time and space resolution's impedance signal and pressure data.

Description

Manometry device and manometry system for determining the function of a hollow organ

technical field

The present application relates to a manometry device and a manometry system for determining the function of a hollow organ, especially an integrated multi-mode high-resolution manometry device and manometry system. the

Background technique

The gastrointestinal tract moves nutrients and fluids from the mouth to the intestines where they are absorbed. Food is swallowed into the esophagus and carried to the stomach, where it is further broken down before entering the small intestine. the

A variety of esophageal and bowel disorders can interfere with or inhibit normal mechanical function of the esophagus/bowel and may cause different symptoms. Along with abnormal function of these organs, patients may exhibit symptoms such as pain. Disorders such as systemic sclerosis and achalasia may interfere with the normal function of the esophagus. Some of the most common gastrointestinal disorders are known as "functional disorders" and have no known cause. Therefore, such diseases cannot be diagnosed by conventional diagnostic tools such as recording pressure and medical imaging techniques. the

Gastrointestinal disorders are probably the most prevalent and common among all diseases, and lead to a large number of patients visiting the hospital every year. Because the incidence of such diseases has been high and the existing diagnostic techniques are difficult to accurately diagnose these diseases. Therefore, it is of great significance and value to develop new diagnostic techniques for gastrointestinal functional diseases. the

Utility model content

Patients with gastrointestinal symptoms usually require gastrointestinal function testing. These tests usually need to be performed by professional technicians or nurses in the gastrointestinal motility laboratory. Most large hospitals with gastroenterology departments are equipped with gastrointestinal motility laboratories. Currently, the most widely used esophageal detection techniques are esophageal manometry, pH recording, and endoscopy. In particular, esophageal pressure measurement technology has achieved great development in recent years. The latest esophageal pressure measurement technology has better spatial resolution, and also has the function of displaying data by color contour map. the

Over the past fifteen years, new impedance techniques (intraluminal impedance) and high-resolution manometry (HRM) have been increasingly used in GI laboratories. In these techniques, catheter devices incorporating multiple electrodes are used. Multiple electrodes are evenly distributed on the catheter along the axial direction of the catheter, so resistance and pressure data with high spatial resolution and high time resolution can be recorded. When a flowing bolus of food caused by swallowing or contraction of the esophageal wall caused by acid reflux passes over these electrodes, there is a corresponding change in resistance and pressure values. Therefore, using these techniques, it is possible to track the movement of the food bolus and measure its speed. However, these techniques have certain limitations. They can only detect organ functions under normal conditions, and cannot be used to detect organ functions under stimulation. In recent years, stimulus detection techniques have been developed. The principles of these stimulation detection techniques include: applying mechanical stimulation to internal organs through balloon expansion; or applying stimulation to internal organs through acid injection and other methods. For the sake of simplicity, the term "balloon expansion" is used in the rest of the description of the present invention. Balloons for expansion are available in a variety of different materials and are sized or stretchable. However, it is necessary to develop new integrated technologies. One of the reasons for the lack of such technical approaches is likely due to the fact that there is still little research on how to make better use of physiologically relevant signals. Another reason is that it is difficult to optimize the spacing between multiple electrodes and sensor selection to meet the needs of more advanced detection and analysis. the

Based on the above considerations, it is of great significance to develop new devices, systems and methods that can obtain better and more detailed data/information of the esophagus or gastrointestinal tract and can be used for clinical diagnosis. the

The utility model provides a pressure measuring device for determining the function of a hollow organ, which comprises:

An elongated body of sufficient length that its distal end may extend into a patient's hollow viscera when the proximal end of the body, or a connector associated with the proximal end, is located outside the patient's oral cavity, pharynx, or oral cavity and body organs such as the esophagus or intestines; and

A plurality of electrodes disposed on said elongated body at known spacings, some of which can excite an electric field, detect in an electric field, or perform excitation and detection in an electric field, or measure Pressure at multiple points along the long body axis, so that data on internal organ responses to stimuli and responses can be obtained; and

One or more devices for stimulating the internal organs, including dilating balloons, thermal stimulation, chemical stimulation, or electrical stimulation devices, with electrodes inside the balloons that measure electrical resistance, which can be converted into ball Internal diameter of the capsule at various locations. the

Further, it includes at least 30 electrodes. the

Further, the plurality of electrodes are equally spaced from each other. the

Further, it also includes: one or more sensors arranged along the elongated body, the sensors are used to: obtain pH data and/or other data related to chemical characteristics; measure position and acceleration data; obtain potential difference data; or Used to obtain other relevant physiological data, the main purpose of installing these sensors is to obtain detailed data related to the response characteristics of the body's organs to stimuli. the

The utility model also provides a pressure measurement system, including any one of the above equipment; and a stimulation system with data collection and processing functions, the system is connected with the elongated main equipment to obtain and process the The data of the elongated subject device described above and the sensory data of the researchee. the

Further, a display device is also included, the display device is connected to one or more data acquisition and processing systems, and is connected to the elongated body device, and the display device is used to visually display the measured or calculated data. the

The utility model relates to a set of devices and a system, which can realize simultaneous collection of impedance signals and pressure data with high time and space resolution. In addition, different types of stimuli can be applied to the organ, such as controlled mechanical stimulation of the organ through an inflatable balloon or thermal and chemical stimulation in other ways. The unique feature of the utility model is that various stimuli are controllable and can be quantified. While applying stimulation, high spatial resolution data from various parts of the detected organ can be recorded synchronously, just as HRM technology can simultaneously measure and record the pressure data at every 1CM position along the axis of the detected organ. Therefore, this feature of the present invention makes it possible to establish a "stimuli-response" relationship of internal organs. This "stimulus-response" relationship is crucial for evaluating the response characteristics of the human body to stimuli. The catheter device and system involved in the preferred solution of the present utility model can be briefly described as: on a section of long catheter, an electrode that can be used to measure pressure or impedance is installed at an interval of 1 cm; An inflated balloon; a side hole is opened on the catheter section very close to the balloon installation site for injecting fluid; some electrodes on the catheter section covered by the installed balloon are located inside the balloon, these The electrodes are specially used to measure the resistance value at intervals of 1 cm inside the balloon, and these resistance values can be converted into the diameter of the internal cross-section of the balloon at these positions. The catheter set can be further expanded into a complete system that includes, in addition to the catheter set, a data display assembly and one or more data acquisition and analysis systems that can be manually connected. the

Description of drawings

The features, advantages and innovations of this utility model can be well understood with reference to the following detailed description of various preferred solutions involved in the utility model and the accompanying drawings. the

Figures 1a and 1b respectively show a preferred configuration with electrodes, a balloon, and a side hole for injecting chemicals. Also shown in Fig. 1b is a heating patch 6 placed on the outer surface of the balloon for applying thermal stimulation. the

Fig. 2 shows two cross-sectional schematic diagrams of the catheter device involved in the present invention. One solution is to pass all the wires 8 connected to the electrodes through a specific lumen 7 to be installed inside the catheter (Fig. 2.a); the other is to insert all the wires 8 connected to the electrodes directly into the catheter during processing to the inside of the catheter (Fig. 2.b). the

Fig. 3 shows a schematic diagram of the system composition of a preferred solution involved in the present invention. the

Detailed ways

In a preferred version of the device of the present invention, the device involved comprises an elongated main body, namely a catheter 1, which has a sufficient length so that when the proximal end of the catheter device is located in the patient's oral cavity, pharynx or oral cavity and the body When external to the patient's stomach, its distal end can extend into the gastroesophageal junction or intestine of the patient. Along the axial direction of the catheter device 1, a plurality of electrodes 2 are installed, and the distance between two adjacent electrodes is fixed and known. Some of the electrodes 2 can not only measure the pressure, but also can be used to generate an electric field, and detect in the electric field, or perform excitation and detection in the electric field. As many as 30 or more electrodes can be accommodated within the catheter device. the

In another preferred device solution of the present utility model, the electrodes 2 involved are installed in an equidistant manner. In another preferred solution, the distance between any two electrodes is known, but not necessarily installed in an equidistant manner. All these electrodes are connected to the system through wires 8, and the wires can be placed inside the catheter through a specific lumen 7 in the catheter 1, or can be integrated with the material of the catheter by embedding. In another preferred solution, the catheter device 1 comprises one or several balloons 3 for dilation of the organ. Through one or more side holes 4 connected to one or more lumens 10 in the catheter, fluid can be inflated into the balloon, recirculated or drained out of the balloon (Figs. 2A and 2B). the

Electrodes for measuring resistance are installed on the catheter, and the measured resistance value can be converted into the diameter of the internal cross-section of the balloon, so as to realize the accurate quantification of the mechanical stimulation applied to the viscera by balloon expansion. In this preferred solution and another preferred solution, one or more side holes 5 and one or more internal channels 9 are also provided on the catheter device for injecting chemical substances into the lumen of the organ. the

When using the device of the present invention, the following steps should be followed: first place part or all of the catheter device in the patient's esophagus or intestinal tract, and then operate the entire device system to obtain data in the official cavity of the gastrointestinal tract. the

The utility model also includes different subsystems. As shown in Figure 3, a catheter device 1 and a computer 11 are included in a preferred solution of the present utility model, and the computer is connected to the signal control device 12, electrodes or other sensors through a cable 15, or connected to the stimulation application unit (such as pumps used to inflate the balloon, etc.). The electrodes 2 and other sensors on the catheter device are connected to the data acquisition and processing system 13 and the display device 14 through cables. Different parts of the whole system can be connected by cables 15, but in a preferred solution, data can be transmitted wirelessly. The display device 14 or the computer 11 contains a storage medium for real-time data storage or offline analysis. the

Understanding the function of the human body in response to external stimuli is very important for our understanding of the body's physiology and diseases, as well as for the development of new instruments and testing techniques. There have been very detailed descriptions on a device or system that integrates stimulation functions on the gastrointestinal tract or other hollow organs and can simultaneously acquire different high-resolution data signals. These schemes only provide non-limiting forms of the present invention, so further modifications and improvements can be made to these schemes. And some components can be replaced by similar products without departing from the essence and scope of the present utility model. With regard to the above-mentioned content, the utility model does not intend to be exhaustive or limited. the

Claims (6)

1. A manometry device for determining the function of a hollow organ, the device comprising: An elongated body of sufficient length that its distal end may extend into a patient's hollow viscera when the proximal end of the body, or a connector associated with the proximal end, is located outside the patient's oral cavity, pharynx, or oral cavity and body organs such as the esophagus or intestines; and A plurality of electrodes disposed on said elongated body at known spacings, some of which can excite an electric field, detect in an electric field, or perform excitation and detection in an electric field, or measure Pressure at multiple points along the long body axis, so that data on internal organ responses to stimuli and responses can be obtained; and One or more devices for stimulating the internal organs, including dilating balloons, thermal stimulation, chemical stimulation, or electrical stimulation devices, with electrodes inside the balloons that measure electrical resistance, which can be converted into ball Internal diameter of the capsule at various locations. the 2. The apparatus of claim 1 comprising at least 30 electrodes. the 3. Apparatus according to claim 1 or 2, said plurality of electrodes being equally spaced from each other. the 4. The device according to any one of claims 1-3, further comprising: One or more sensors disposed along the elongated body for: obtaining pH data and/or other chemically related data; measuring position and acceleration data; obtaining potential difference data; or for obtaining other relevant Physiological data, the main purpose of installing these sensors is to obtain detailed data related to the response characteristics of the body's organs to stimuli. the 5. A manometry system, comprising the device described in any one of claims 1-4; and a stimulation system with data acquisition and processing functions, the system is connected with the elongated main body device to obtain and process the The data of the elongated subject device and the sensory data of the researcher. the 6. The manometry system of claim 5, further comprising a display device coupled to one or more data acquisition and processing systems and coupled to said elongated body device, said display device Used to visualize measured or calculated data. the