阅读说明：本技术 一种食管上括约肌失弛缓节段定位装置及测量方法 (Esophageal upper sphincter achalasia segment positioning device and measuring method ) 是由 怀娟 尹森 岳寿伟 吴淼 怀初富 于 2021-09-28 设计创作，主要内容包括：本发明涉及一种食管上括约肌失弛缓节段定位装置及测量方法。肉毒毒素注射治疗吞咽障碍具有创伤小、操作便利的优势,难度在于对失弛节段肌肉的精准定位。现有食管上括约肌失弛节段测量装置通常采用上下缘定位球囊进行定位,但是这种定位方式能够测量的失弛缓节段长度有限,并且结构复杂,管径较粗,给患者带来诸多不适。本发明提供了一种食管上括约肌失弛缓节段定位装置,设置了一种更加灵活的定位区,使定位装置可测量的范围更大,测量更加灵活,有效降低患者的不适,具有良好的临床应用价值。(The invention relates to a device and a method for positioning a achalasia segment of an upper esophageal sphincter. The botulinum toxin injection for treating the swallowing disorder has the advantages of small trauma and convenient operation, and the difficulty lies in the accurate positioning of the muscles of the achalasia segment. The existing measuring device for the upper esophageal sphincter achalasia section is usually positioned by adopting an upper and lower edge positioning balloon, but the achalasia section which can be measured by the positioning mode has limited length, complex structure and thick pipe diameter, and brings much discomfort to patients. The invention provides a device for positioning the achalasia section of the upper esophageal sphincter, which is provided with a more flexible positioning area, so that the positioning device has a larger measurable range and more flexible measurement, can effectively reduce the discomfort of a patient, and has good clinical application value.)

1. The device for positioning the achalasia section of the upper sphincter of the esophagus is characterized in that a main body of the positioning device is a guide tube with one closed end, the guide tube is provided with a positioning area, a plurality of through holes are distributed on the tube wall of the positioning area, and a film is coated on the outer portion of the tube wall of the positioning area.

2. The device for positioning the Upper esophageal sphincter achalasia section of claim 1, wherein the upper and lower edges of the positioning region have inner seals, and the through hole is distributed between the two inner sealed regions, wherein the inner seal at the upper edge has an injection tube extending toward the mouth of the guiding tube.

3. The device for locating the Upper esophageal sphincter achalasia according to claim 2, wherein the measuring device has two locating areas separated by an inner seal, and the upper edges of the two locating areas are provided with injection catheters respectively extending to the mouth of the guide tube.

4. The device for locating the Upper esophageal sphincter achalasia section of claim 3, wherein the balloon of the superior border location area is spherical with a diameter of 25-35 mm after being filled with water in an unconstrained state.

Or the balloon at the lower edge positioning area is spherical with the diameter of 25-35 mm after being filled with water in an unconstrained state.

5. The device for locating the upper esophageal sphincter achalasia segment of claim 1, wherein the device is visualized by: the inner wall of the film is coated with a developing reagent, after the positioning device is stretched into the pharynx of a patient, the film is inflated or filled with water from the pipe orifice, so that the film naturally expands, and the position and the length of the achalasia section are observed and measured through developing equipment.

6. The esophageal upper sphincter relaxant segment positioning device of claim 5, wherein said visualization reagent includes but is not limited to a visualization solution, physiological saline or water;

alternatively, the visualization device is selected from the group consisting of, but not limited to, X-ray, ultrasound, CT, and nuclear magnetic resonance.

7. The device for locating the upper esophageal sphincter achalasia segment of claim 1, wherein the guiding tube is made of a soft material; preferably, the guide tube is made of silicon rubber, and further, the surface of the guide tube is provided with a natural latex coating.

8. The device for locating the upper esophageal sphincter achalasia segment of claim 7, wherein the guide tube has a diameter of 4-6 mm, in particular 5 mm;

or the length of the guide pipe is 18-22 cm, specifically 19, 20 or 21 cm.

9. The upper esophageal sphincter relaxant segment positioning device of claim 1, wherein said guide tube further has a tubular core inside, said tubular core extending from the orifice to the closed end;

further, the tube core is made of PVC material;

furthermore, a lead is attached to the tube core and connected with a pressure sensor, the pressure sensor and the lead extend out of the guide tube along the tube core and transmit pressure data to a data acquisition system.

10. A method for measuring the muscle of upper esophageal sphincter relaxant segment, which is implemented by using the device for locating upper esophageal sphincter relaxant segment according to any one of claims 1-9;

preferably, in the positioning device, the pipe wall of the guide pipe is provided with scales.

Technical Field

The invention belongs to the technical field of muscle positioning and measuring instruments, and particularly relates to a device for positioning an upper esophageal sphincter achalasia segment and a method for measuring the length of the achalasia segment.

Background

The information in this background section is only for enhancement of understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art that is already known to a person of ordinary skill in the art.

Dysphagia is a common clinical symptom, and any disease in the passage from the mouth to the stomach can cause dysphagia, and can be classified into neurogenic (cerebrovascular accident, craniocerebral trauma, Parkinson disease, amyotrophic lateral sclerosis, vagus nerve or recurrent laryngeal nerve injury, etc.), myogenic, tumor, infection, iatrogenic injury, etc. according to different causes. Among the swallowing disorders caused by brain damage diseases, the upper esophageal sphincter relaxations are a common cause. At present, the clinical treatment of esophageal upper sphincter achalasia usually adopts swallowing function training, balloon dilatation, injection of the botulinum toxin type A of the cricopharyngeal muscle, incision of the cricopharyngeal muscle and the like. Among them, botulinum toxin injection has less wound and simple operation, but it is difficult to realize accurate positioning.

Accurate positioning of the upper esophageal sphincter achalasia segment becomes a technical problem. Dysphagia 2020 4 describes a method for positioning the lower edge of the achalasia segment of the upper esophageal sphincter under the assistance of CT, but the method cannot position the upper edge of the segment and cannot measure the length of the achalasia segment. Based on the positioning method, the therapist cannot accurately know the position and the volume of the muscle of the achalasia segment, so that the injection position and the injection dosage cannot be confirmed. In addition, a device for evaluating and treating the cricopharyngeal muscle achalasia (as shown in fig. 1) is provided in patents CN102366325B and CN 212089563U, and the inflated balloon is used for indicating the position of the esophageal achalasia section, so as to realize the positioning and measurement of the upper edge and the lower edge of the esophageal sphincter achalasia section. The inventor finds in actual clinical work that the measuring device in the patent needs certain rigidity support, and a thicker pipe diameter is also needed for accommodating the balloon device; during the measurement process, the patient has to endure the obvious foreign body sensation at the throat part, and regurgitation and vomiting are easily caused. In addition, in the above device, the position of the upper and lower edge balloons is fixed, and the medical staff must repeatedly adjust the degree of the measurement device extending into the throat in order to smoothly inflate the upper and lower edge balloons of the measurement device, otherwise the sag section may obstruct the inflation of the balloon; this further exacerbates patient discomfort, prolongs the measurement process, and is prone to damage to the mucosal tissue of the pharynx.

Disclosure of Invention

Based on the current research situation, the invention aims to provide a measuring device for the upper esophageal sphincter achalasia segment, which has better patient adaptability and is more convenient to operate, and a measuring device with a thinner tube diameter and is more convenient for medical staff to operate is expected. In order to achieve the technical purpose, the invention provides the following technical scheme:

the invention provides a device for positioning a achalasia section of an upper esophageal sphincter, which comprises a main body of a positioning device, wherein one end of the main body of the positioning device is closed, the guide tube is provided with a positioning area, a plurality of through holes are distributed on the tube wall of the positioning area, and a film is coated on the outer portion of the tube wall of the positioning area.

Referring to fig. 1, the positioning device provided in the prior art generally comprises two position-limiting air bags with an upper edge and a lower edge, which also results in that when the length of the muscular relaxant segment exceeds the upper and lower edges of the positioning device (positions 2 and 9 in fig. 1), the air bag cannot be inflated smoothly, and the device cannot be positioned. In addition, when a measurer uses the measuring device, the measurer needs to stretch into a section of the pharyngeal portion of the patient, and then tries to inflate or fill the developing solution, if the upper edge or the lower edge suffers from resistance in the liquid filling process, a medical worker can only continuously adjust the position of the measuring device, stretch the device into or out, and then tries to fill the liquid, and the stretching and pulling actions cause strong discomfort to the pharyngeal portion of the patient.

In view of the above technical problems, the present invention proposes to provide a more flexible positioning region on the guide tube of the measuring device, wherein the positioning region is formed by providing a plurality of through holes on the tube wall, the developing solution naturally flows to the non-narrow cavity in an overflow-like manner, and the thin film is supported to form a balloon, so that the length and position of the muscle in the achalasia section can be displayed under the action of CT scanning. The arrangement of the positioning area firstly enlarges the measurable range of the positioning device and secondly effectively avoids the process that a measurer needs to stretch in and pull out the measuring device to be continuously debugged.

Preferably, the upper and lower edges of the positioning area are provided with inner seals, the through holes are distributed between the two inner seal areas, and the inner seal at the upper edge is provided with an injection tube extending towards the nozzle of the guide tube.

In the above preferred embodiment, the positioning region has an upper edge and a lower edge, and it should be understood that the upper edge near the nozzle of the guide tube and the lower edge near or at the closed end of the guide tube are determined according to the position relationship. Wherein, the injection tube, the two inner seals and the film form a section of communicated cavity. The developing agent will naturally flow to the non-narrow section after entering the positioning area from the injection tube, so that the swelling film draws the image of the achalasia section. The structure has the advantages that the guide tube is provided with fewer structures, so that the tube diameter of the guide tube can be made thinner and even can extend into the nasal cavity, the stimulation to a patient is smaller, and the patient can move freely in the measuring process.

Preferably, the measuring device is provided with two positioning areas which are separated by an inner seal, and the upper edges of the two positioning areas are respectively provided with an injection catheter extending to the nozzle of the guide tube.

Furthermore, the balloon in the upper edge positioning area is spherical with the diameter of 25-35 mm after being filled with water in an unconstrained state.

Furthermore, the balloon in the lower edge positioning area is spherical with a diameter of 25-35 mm after being filled with water in an unconstrained state.

In the preferred technical scheme, the two positioning areas are used for positioning the upper edge and the lower edge respectively, the two positioning areas are separated by the inner seal, and the two positioning areas, the injection tube, the inner seal and the film can form two independent balloons. The structure has the advantages that the two balloons can be injected with different developers to respectively position the upper edge and the lower edge of the upper esophageal sphincter achalasia section, so that the visual effect is better. Another advantage is that when the positioning device is used, a measurer extends the guide tube into the pharynx of a patient, then injects the developer into the lower edge positioning area, and after the film is expanded into a balloon, the balloon is pulled out, the lower edge balloon is clamped by the upper esophageal sphincter achalasia section, and then injects the developer into the upper edge positioning balloon for developing. In the use process of the device, only one-time debugging is needed, and the technical defect that the measuring device needs to be continuously stretched into and pulled out in the prior art is effectively overcome.

Further, the above solution describes a positioning device, and the development method thereof is as follows: the inner wall of the film is coated with a developing reagent, after the positioning device is stretched into the pharynx of a patient, the film is inflated or filled with water from the pipe orifice, so that the film naturally expands, and the position and the length of the achalasia section are observed and measured through developing equipment.

Further, the developing agent includes, but is not limited to, a developing solution, physiological saline or water.

Still further, the visualization device is selected from the group consisting of, but not limited to, X-ray, ultrasound, CT, and nuclear magnetic resonance.

Preferably, in order to reduce the irritation of the positioning device to the pharynx of the patient, the guide tube is made of a soft material; specific examples are silicone rubber materials, and further, the surface of the guide tube is provided with a natural latex coating so as to reduce the possibility of allergy.

Furthermore, the diameter of the guide pipe is 4-6 mm, specifically 5 mm.

Furthermore, the length of the guide pipe is 18-22 cm, specifically 19, 20 or 21 cm.

Preferably, the guide tube further comprises a tubular core inside, the tubular core extends from the mouth to the closed end and has certain rigidity for controlling the trend of the guide tube after entering the throat of the patient.

In a further aspect, the tube core is made of PVC.

In a further scheme, a lead is attached to the tube core, the lead is connected with a pressure sensor, the pressure sensor is attached to the film, and the lead extends out of the guide tube along the tube core and transmits pressure data to the data acquisition system.

In a second aspect of the invention, a method for measuring the muscle of the upper esophageal sphincter relaxant segment is provided, wherein the measuring method is realized by adopting the positioning device in the first aspect.

Preferably, in the positioning device, the pipe wall of the guide pipe is provided with a scale for assisting in reading the length value of the slack section.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and together with the description serve to explain the invention and not to limit the invention.

FIG. 1 is a prior art upper esophageal sphincter achalasia segment measurement device;

wherein: the device comprises a guide tube 1, a balloon for positioning the lower edge of the upper sphincter of the esophagus, a balloon for positioning the upper edge of the upper sphincter of the esophagus 3, a tube core 4, a balloon injection hole for positioning the lower edge of the upper sphincter of the esophagus 5, a balloon injection hole for positioning the upper edge of the upper sphincter of the esophagus 6, a balloon injection catheter for positioning the lower edge of the upper sphincter of the esophagus 7, a balloon injection catheter for positioning the upper edge of the upper sphincter of the esophagus 8, a film pressure sensor 9, a film pressure sensor lead 10, a film pressure sensor data acquisition system 11 and an indication system 12 for indicating the position of the upper sphincter of the esophagus.

FIG. 2 is a cross-sectional view showing the overall structural design of the esophageal upper sphincter relaxant segment measuring device in example 1;

FIG. 3 is a schematic view showing the positioning state of the esophageal upper sphincter relaxant segment measuring device in example 1;

in the above fig. 2 and fig. 3, 1-1 is a guiding tube, 1-2 is a film, 1-2' is a balloon formed when the film is in a working state, 1-3 is a tube core, 1-4 is an injection port, 1-5 is an injection tube, 1-6 is a pressure sensor, 1-7 is a conducting wire, 1-8 is a data acquisition system, 1-9 is an indication of the position of the upper sphincter of the esophagus, 1-10 is a through hole, 1-11 is an inner seal of a positioning region, and 1-12 is a developer.

FIG. 4 is a cross-sectional view showing the overall structural design of the esophageal upper sphincter relaxant segment measuring device in example 2;

FIG. 5 is a schematic view showing the positioning of the lower edge of the esophageal upper sphincter relaxant section measuring device in example 2;

FIG. 6 is a schematic view showing the overall positioning of the esophageal upper sphincter relaxant segment measuring device in example 2;

in the above fig. 4-6, 2-1 is a guiding tube, 2-2 is a lower edge positioning region, 2-3 is an upper edge positioning region, 2-4 is a tube core, 2-5 is an injection hole of the lower edge positioning region, 2-6 is an injection hole of the upper edge positioning region, 2-7 is an injection tube of the upper edge positioning region, 2-8 is an injection tube of the lower edge positioning region, 2-9 is a thin film pressure sensor, 2-10 is a conducting wire, 2-11 is a data acquisition system, 2-12 is a schematic position of upper sphincter achalasia section of esophagus, 2-13 is an inner seal, 2-14 is a through hole, 2-15 is a developer 1, 2-16 is a developer 2.

Detailed Description

It is to be understood that the following detailed description is exemplary and is intended to provide further explanation of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

As described in the background art, the prior art has the defect that the measuring device for the upper esophageal sphincter achalasia section is inconvenient to use, and in order to solve the technical problems, the invention provides a positioning device for the upper esophageal sphincter achalasia section, which improves the convenience of measuring operation by arranging a more flexible positioning area.

In order to make the technical solutions of the present invention more clearly understood by those skilled in the art, the technical solutions of the present invention will be described in detail below with reference to specific embodiments.

Example 1

In the embodiment, a device for positioning a achalasia section of an upper esophageal sphincter is provided, as shown in fig. 2, a main body of the positioning device is a guide tube 1-1 with one closed end, the guide tube is provided with a positioning area, a plurality of through holes 1-10 are uniformly distributed on the tube wall of the positioning area, a thin film 1-2 is arranged outside the tube wall of the positioning area for sealing, and the thin film 1-2 covers all the through holes 1-10.

The upper edge of the positioning area is close to the opening end of the guide tube 1-1, the lower edge of the positioning area is close to the closed end of the guide tube, the upper edge and the lower edge of the positioning area are respectively provided with an inner seal 1-11, wherein the inner seal of the upper edge is provided with an injection tube 1-5 extending towards the opening end of the guide tube 1-1, the injection tube 1-5, the positioning area and the film 1-2 form a closed cavity, and the cavity is not communicated with the inside of the guide tube.

The guide tube 1-1 is also internally provided with a tube core 1-3, and the tube core 1-3 is positioned at the central shaft of the guide tube 1-1 in an upright state. The guide tube 1-1 is made of soft silica gel materials, and the tube core 1-3 is made of silica gel materials. The tube core 1-3 is attached with a lead 1-7, the lead 1-7 is connected with a 1-6 pressure sensor distributed on the inner wall of the film, the other end of the lead 1-7 extends out of the guide tube 1-1 to be connected with an external data acquisition system 1-8, and the film pressure data is transmitted to the data acquisition system 1-8.

The positioning device is used as follows: the guiding tube 1-1 is extended into the pharynx of a patient, the closed end of the guiding tube 1-1 is enabled to inject the developer 1-12 to the positioning area through the injection port 1-4, the developer 1-12 penetrates through the through hole 1-10 to support the film 1-2 to form a 1-2' balloon state, the balloon is extruded by the upper esophageal sphincter achalasia section 1-9 to be expanded in two sections, the position and the length of the upper esophageal sphincter achalasia section can be confirmed through observation of a developing device, and the injection position and the dosage of the botulinum toxin can be confirmed.

Example 2

In this embodiment, another device for positioning the upper esophageal sphincter achalasia segment is provided, which is different from embodiment 1 in that in this embodiment, the positioning device has two positioning regions: an upper edge positioning zone 2-3 and a lower edge positioning zone 2-2.

As shown in figure 4, the upper edge positioning region 2-3 and the lower edge positioning region 2-2 are separated by an inner seal 2-13, and the inner seals 2-13 on the upper edges are respectively provided with openings through which the injection tubes extend to the guide tube 2-1. Wherein, the injection tube 2-6 and the upper edge positioning area 2-3 form a closed cavity, the injection tube 2-5 and the lower edge positioning area 2-2 form a closed cavity, and the two cavities are independent.

The positioning device provided in this embodiment is used in the following manner: the positioning device is inserted into the pharynx of the patient and the closed end of the guide tube is stopped passing through the achalasia section. Injecting a developer into the lower edge positioning area 2-2 through the injection tube 2-5, stopping injection after the lower edge positioning area 2-2 is sensed to be expanded, and pulling back the positioning device until the balloon expanded in the lower edge positioning area 2-2 of the positioning device touches the relaxation section 2-12; the state at this time is shown in fig. 5. Then, a developer is injected into the injection pipes 2 to 6 to swell the films in the upper edge positioning regions 2 to 3, and as shown in fig. 6, the upper edge and the lower edge of the sag section are determined by a developing device, thereby realizing positioning and measurement.

In a possible embodiment of this embodiment, the upper edge positioning region 2-3 and the lower edge positioning region 2-2 use different developers, so that the positions of the upper and lower edge positioning regions can be more intuitively distinguished. As shown in fig. 6, the balloon in the upper edge positioning area 2-3 is filled with developer 2, and the balloon in the lower edge positioning area 2-2 is filled with developer 1.

The developer 1 and the developer 2 are in separate chambers, and in another embodiment, a measurer may select the same developer for development.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.