Esophageal PH-electromyoelectric combined electrode catheter

Abstract

The present invention discloses an esophageal PH-electromyographic combined electrode catheter, comprising a tube body, a PH wire and a diaphragm wire, wherein the surface of the tube body is provided with two PH electrodes, a plurality of diaphragm electrical signal recording electrodes and a diaphragm electrical signal reference electrode; the two PH electrodes are respectively at the end and the middle of the tube body, the plurality of diaphragm electrical signal recording electrodes are all located between the two PH electrodes, and the diaphragm electrical signal reference electrode is located at the proximal end of the PH electrode in the middle; all the PH electrodes are connected to the PH wire in the tube body, and the signal output end of the PH wire is provided with a PH processor connector; the diaphragm electrical signal reference electrode and all the diaphragm electrical signal recording electrodes are connected to the diaphragm wire in the tube body, and the signal output end of the diaphragm wire is provided with an amplifier connector. The present invention can not only improve the accuracy of catheter positioning and simplify operation, but also reduce the patient's discomfort, and can also detect diaphragm function and help discover the cause of gastroesophageal reflux.

Description

Technical Field

[0001] The present invention relates to medical equipment, in particular to an esophageal PH-myoelectricity combined electrode catheter. Background Art

[0002] Gastroesophageal reflux is primarily acidic and can manifest as acid regurgitation, heartburn, retrosternal pain, and chronic cough. The main causes of gastroesophageal reflux include lower esophageal sphincter dysfunction, weakened diaphragmatic crus clamping effect, and decreased esophageal motility. In theory, diaphragmatic impairment can weaken the clamping effect of the diaphragmatic crus, reducing lower esophageal sphincter pressure and leading to gastroesophageal reflux. However, currently, there is no single catheter that can accurately monitor both diaphragmatic function and gastroesophageal reflux.

[0003] 24-hour esophageal pH monitoring is an adjunctive method for detecting gastroesophageal reflux. Accurate placement of the esophageal pH electrode catheter is closely related to test results. Ideally, the proximal pH electrode should be placed 5 cm from the proximal edge of the lower esophageal sphincter. Commonly used positioning methods in clinical practice include esophageal manometry and pH gradient methods.

[0004] Esophageal manometry relies on the high-pressure band generated by the physiological lower esophageal sphincter, which serves as the primary defense against gastroesophageal reflux. However, this method requires two intubations, which increases patient discomfort. Furthermore, the equipment required for manometry is complex and expensive. Furthermore, in most patients with gastroesophageal reflux, the high-pressure band in the lower esophageal sphincter is not readily apparent, making it difficult to accurately locate.

[0005] The pH gradient method uses the significant difference in pH between the stomach and esophagus to place the electrodes. However, in patients with hyperacidity or hypoacidity, the pH gradient between the esophagus and stomach is not obvious, which affects positioning.

[0006] The esophageal manometry and pH gradient methods used above are affected by many factors, making it impossible to accurately position the catheter, affecting the judgment of gastroesophageal reflux, and unable to detect diaphragm function. Summary of the Invention

[0007] The present invention aims to overcome the shortcomings of the above-mentioned existing technologies and provides an esophageal pH-myoelectric combined electrode catheter. This esophageal pH-myoelectric combined electrode catheter has a simple structure, improves catheter positioning accuracy, simplifies operation, reduces patient discomfort, and can also detect diaphragmatic function, helping to identify the cause of gastroesophageal reflux.

[0008] The objectives of the present invention are achieved through the following technical solutions: The esophageal PH-electromyography combined electrode catheter comprises a tube body, a PH wire and a diaphragm wire, the surface of the tube body is provided with two PH electrodes, multiple diaphragm electrical signal recording electrodes and a diaphragm electrical signal reference electrode; the two PH electrodes are respectively arranged at the distal end and the middle part of the tube body, the multiple diaphragm electrical signal recording electrodes are all located between the two PH electrodes, and the diaphragm electrical signal reference electrode is located between the PH electrode in the middle of the tube body and the proximal end of the tube body; all the PH electrodes are connected to the PH wire inserted into the tube body, and the signal output end of the PH wire is provided with a PH processor connector; the diaphragm electrical signal reference electrode and all the diaphragm electrical signal recording electrodes are connected to the diaphragm wire inserted into the tube body, and the signal output end of the diaphragm wire is provided with an amplifier connector.

[0009] Preferably, the number of diaphragm electrical signal recording electrodes is 5, and the distance between two adjacent diaphragm electrical signal recording electrodes is equal; from the distal end to the proximal end of the tube body, the insulation distance between the pH electrode located at the distal end of the tube body and the diaphragm electrical signal recording electrode located in the first position is greater than 5 cm, and the distance between the pH electrode located in the middle of the tube body and the diaphragm electrical signal recording electrode located in the middle position is equal to 5 cm.

[0010] Preferably, the distance between two adjacent diaphragm electrical signal recording electrodes is 1 cm.

[0011] Preferably, the five diaphragm muscle electrical signal recording electrodes form three leads of the same specifications, and between the two diaphragm muscle electrical signal electrodes in each lead there is one diaphragm muscle electrical signal recording electrode constituting another lead.

[0012] Preferably, the length of the diaphragm electrical signal recording electrode and the diaphragm electrical signal reference electrode are both 1 cm.

[0013] Preferably, the lengths of the two pH electrodes are both less than 1 cm.

[0014] Preferably, a seal is provided at the distal end of the tube body, and a bifurcation is provided at the proximal end of the tube body, and both the PH wire and the diaphragm wire are inserted into the tube body through the bifurcation.

[0015] The present invention has the following advantages over the prior art:

[0016] 1. This esophageal pH-electromyography combined catheter integrates the diaphragm muscle electrical signal recording electrode, diaphragm muscle electrical signal reference electrode, pH electrode, diaphragm muscle electrical wire, and pH wire into the tube body, thereby simultaneously realizing the detection of diaphragm muscle electromyography, intragastric pH value, and esophageal pH value. This can not only accurately locate the position of the lower esophageal sphincter and identify whether gastroesophageal reflux occurs, but also accurately record diaphragm muscle electromyography, provide a preliminary understanding of diaphragm function, and thus help discover the cause of gastroesophageal reflux.

[0017] 2. This esophageal pH-electromyography combined catheter does not require the placement of two catheters like traditional catheters for positioning and detecting the pH value of the gastroesophageal tract, simplifies the operation of accurate catheter placement, reduces examination costs, and alleviates patient discomfort. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a schematic structural diagram of the esophageal PH-electromyography combined electrode catheter of the present invention.

[0019] Among them, 1 and 2 are pH electrodes, 3-7 are diaphragm signal recording electrodes, 8 is the diaphragm signal reference electrode, 9 is the tube body, 10 is the bifurcation head, 11 is the pH wire, 12 is the diaphragm wire, 13 is the pH processor connector, 14 is the amplifier connector, 15 is the seal, and I, II and III are all leads. DETAILED DESCRIPTION

[0020] The present invention will be further described below with reference to the accompanying drawings and examples.

[0021] like Figure 1 The esophageal PH-electromyographic combined electrode catheter shown includes a tube body, a PH wire and a diaphragm wire. The surface of the tube body is provided with two PH electrodes, multiple diaphragm electrical signal recording electrodes and a diaphragm electrical signal reference electrode; the two PH electrodes are respectively arranged at the distal end (i.e., the end inserted into the human stomach in actual operation) and the middle part of the tube body, and the multiple diaphragm electrical signal recording electrodes are all located between the two PH electrodes. The diaphragm electrical signal reference electrode is located between the PH electrode in the middle of the tube body and the proximal end of the tube body (i.e., the end not inserted into the human body in actual operation); all PH electrodes are connected to the PH wire inserted into the tube body, and the signal output end of the PH wire (i.e., the end extending out of the tube body) is provided with a PH processor connector; the diaphragm electrical signal reference electrode and all diaphragm electrical signal recording electrodes are connected to the diaphragm wire inserted into the tube body, and the signal output end of the diaphragm wire is provided with an amplifier connector. During use, the amplifier connector and the PH processor connector are connected to the diaphragm electrical signal amplifier and the PH processor respectively, and the diaphragm electrical signal amplifier and the PH processor are both connected to a computer to process and display the detection data in the computer; and the diaphragm electrical signal reference electrode is used for grounding to provide a reference for the diaphragm electrical signal recording electrode.

[0022] Among them, the two pH electrodes are pH electrode 1 and pH electrode 2, and the length of pH electrode 1 and pH electrode 2 are both 0.5 mm. pH electrode 1 is close to the seal of the tube body. This pH electrode 1 is used to detect the pH value in the stomach; when introduced into the human body for detection, pH electrode 2 is located about 5 cm from the proximal edge of the lower esophageal sphincter and is used to detect the pH value of the esophagus.

[0023] The number of diaphragm muscle electrical signal recording electrodes is 5, and these 5 diaphragm muscle electrical signal recording electrodes are diaphragm muscle signal recording electrodes 3-7, and the distance between two adjacent diaphragm muscle electrical signal recording electrodes is equal; from the distal end of the tube body to the proximal end of the tube body, the insulation distance between the pH electrode located at the distal end of the tube body and the diaphragm muscle electrical signal recording electrode located in the first position is greater than 5cm, that is, the insulation distance between pH electrode 1 and diaphragm muscle electrical signal electrode 3 is greater than 5cm; and the distance between the pH electrode located in the middle of the tube body and the diaphragm muscle electrical signal recording electrode located in the middle position is equal to 5cm, that is, the distance between pH electrode 2 and diaphragm muscle electrical signal electrode 5 is equal to 5cm. The length of diaphragm muscle electrical signal recording electrodes 3-7 and diaphragm muscle electrical signal reference electrode 8 is 1cm. The distance between two adjacent diaphragm muscle electrical signal recording electrodes is 1cm. This structure is compact, and the appropriate distance can ensure the accuracy of the detection structure.

[0024] The five diaphragm muscle electrical signal recording electrodes form three leads of the same specifications. There is one diaphragm muscle electrical signal recording electrode between the two diaphragm muscle electrical signal electrodes in each lead, which constitutes another lead. Specifically, Figure 1 As shown, diaphragm muscle electrical signal recording electrodes 3 and 5 form Lead I, diaphragm muscle electrical signal recording electrodes 4 and 6 form Lead II, and diaphragm muscle electrical signal recording electrodes 5 and 7 form Lead III. This means that the two diaphragm muscle electrical signal recording electrodes in each lead are separated by a diaphragm muscle electrical signal electrode in the other lead, while Leads I and III share a single diaphragm muscle electrical signal recording electrode 5. By observing the diaphragm muscle EMG amplitude recorded by each lead in real time, when Leads I and III record a signal with similar amplitude that is larger than the signal recorded by Lead II, it indicates that diaphragm muscle signal recording electrode 5 is at the level of the diaphragm in the esophagus, meaning that pH electrode 2 is accurately placed approximately 5 cm from the proximal edge of the lower esophageal sphincter. At this point, because the upper and lower electrodes of Lead II are equidistant from the diaphragm, their potentials cancel each other out, and only a very small diaphragm muscle EMG signal is recorded. Furthermore, by measuring and analyzing the diaphragm muscle EMG signals in each lead, it is possible to preliminarily assess diaphragm function and help identify the causes of gastroesophageal reflux.

[0025] The length of the diaphragm muscle electrical signal reference electrode is 1 cm. The appropriate length of the diaphragm muscle electrical signal reference electrode can further ensure the accuracy of the detection.

[0026] The distal end of the tube body is sealed, and the proximal end of the tube body is provided with a bifurcated head, through which the PH guidewire and diaphragm guidewire are inserted into the tube body. This simple structure ensures a relatively tight seal within the tube body, thereby protecting the PH guidewire and diaphragm guidewire within the tube body.

[0027] The above specific implementation manner is a preferred embodiment of the present invention and does not limit the present invention. Any other changes or other equivalent replacement methods that do not deviate from the technical solution of the present invention are included in the protection scope of the present invention.

Claims

1. Esophageal pH-electromyography combined electrode catheter, characterized by: The device comprises a tube body, a pH wire and a diaphragm wire, wherein the surface of the tube body is provided with two pH electrodes, multiple diaphragm electrical signal recording electrodes and a diaphragm electrical signal reference electrode; the two pH electrodes are respectively arranged at the distal end and the middle part of the tube body, the multiple diaphragm electrical signal recording electrodes are all located between the two pH electrodes, and the diaphragm electrical signal reference electrode is located between the pH electrode in the middle of the tube body and the proximal end of the tube body; all the pH electrodes are connected to the pH wire inserted into the tube body, and the signal output end of the pH wire is provided with a pH processor connector; the diaphragm electrical signal reference electrode and all the diaphragm electrical signal recording electrodes are connected to the diaphragm wire inserted into the tube body, and the signal output end of the diaphragm wire is provided with an amplifier connector; The number of the diaphragm electrical signal recording electrodes is 5, and the distance between two adjacent diaphragm electrical signal recording electrodes is equal; from the distal end to the proximal end of the tube body, the insulation spacing between the pH electrode located at the distal end of the tube body and the diaphragm electrical signal recording electrode located in the first position is greater than 5 cm, and the spacing between the pH electrode located in the middle of the tube body and the diaphragm electrical signal recording electrode located in the middle position is equal to 5 cm; the 5 diaphragm electrical signal recording electrodes form 3 leads of the same specifications, and there is a diaphragm electrical signal recording electrode constituting another lead between the two diaphragm electrical signal electrodes in each lead.

2. The esophageal pH-myography combined electrode catheter according to claim 1, characterized in that: The distance between two adjacent diaphragm electrical signal recording electrodes was 1 cm.

3. The esophageal pH-myography combined electrode catheter according to claim 1, characterized in that: The length of the diaphragm electrical signal recording electrode and the diaphragm electrical signal reference electrode are both 1 cm.

4. The esophageal pH-myography combined electrode catheter according to claim 1, characterized in that: The length of the two pH electrodes is less than 1 cm.

5. The esophageal pH-myography combined electrode catheter according to claim 1, characterized in that: The distal end of the tube body is provided with a seal, and the proximal end of the tube body is provided with a bifurcation head, and the PH wire and the diaphragm wire are both inserted into the tube body through the bifurcation head.

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