CN111228638B

CN111228638B - Balloon dilator for cricopharyngeal muscle

Info

Publication number: CN111228638B
Application number: CN202010120168.1A
Authority: CN
Inventors: 杨道海; 李京民; 高磊
Original assignee: Huai'an Traditional Chinese Medicine Hospital
Current assignee: Huai'an Traditional Chinese Medicine Hospital
Priority date: 2020-02-26
Filing date: 2020-02-26
Publication date: 2022-02-11
Anticipated expiration: 2040-02-26
Also published as: CN111228638A

Abstract

The invention relates to a balloon dilator for the circumpharyngeal muscle, which at least comprises: the endoscope comprises a water charging pipeline (1), a gas charging pipeline (2), a piezoelectric sensor (3), a spring (4), an endoscope probe, a water channel (5) and a gas channel (6); the tension expansion degree can be accurately monitored in real time through sensors such as a piezoelectric sensor and a barometer, muscle expansion can be scientifically carried out, and the treatment effect is improved.

Description

Balloon dilator for cricopharyngeal muscle

Technical Field

The invention relates to the technical field of medical equipment, in particular to a balloon dilator for treating cricopharyngeal muscle achalasia or stenosis.

Background

For the dysfunction of the cricopharyngeal muscle, the uncoordinated swallowing action and the declining pharyngeal sensory function caused by the nervous system diseases to delay the swallowing reflex; head and neck radiation therapy causes strictures in the fibrosis of the cricopharyngeal muscle; patients with esophageal stenosis and the like caused by scar hyperplasia after head and neck cancer operation can improve the spastic state of the cricopharyngeal muscle through balloon dilatation, and improve clinical symptoms of the patients.

Mechanical traction is mostly adopted for treatment, so that the tension, contractility and/or elasticity of the cricopharyngeal muscle are normalized, the physiological opening of the upper esophageal sphincter is promoted, and the dysphagia caused by the functional disorder of the cricopharyngeal muscle is solved, and the technique is called as an expansion technique. Among them, the inflatable balloon or water-filled balloon expansion treatment method is widely used. The adopted apparatus is a catheter, after the catheter is inserted into the esophagus, the water is filled, then the catheter is released and slowly pulled out, and the catheter is expanded through spasm or narrow cricopharyngeal muscle.

However, the conventional balloon dilator for the cricopharyngeal muscle has a certain effect on the stenotic cricopharyngeal muscle by balloon-dilating by pulling the catheter injected with water. However, for spastic circumpharyngeal muscle, the catheter with the inflated balloon is pulled in the esophagus to stimulate the spastic sphincter, which leads to aggravation of the spasm of the circumpharyngeal muscle and poor treatment effect; moreover, the balloon is easy to cause edema and hemorrhage of the esophagus and the laryngeal mucosa after expansion, and certain risks exist.

Therefore, there is a need to provide a balloon dilator for the cricopharyngeal muscle, which can effectively monitor the degree of dilation without the need for manual traction.

Disclosure of Invention

The technical problem to be solved by the invention is as follows: the existing balloon dilator for the cricopharyngeal muscle carries out balloon dilation by pulling a catheter injected with water, and for spastic cricopharyngeal muscle, the catheter expanded by the balloon is pulled in an esophagus to stimulate spastic sphincter, so that the spasm of the cricopharyngeal muscle is aggravated, and the treatment effect is poor; moreover, the balloon is easy to cause edema and hemorrhage of the esophagus and the laryngeal mucosa after being dilated.

The technical scheme adopted by the invention for solving the technical problems is as follows:

a balloon dilator of the cricopharyngeal muscle, comprising at least: the endoscope probe comprises a water filling pipeline 1, a gas filling pipeline 2, a piezoelectric sensor 3, a spring 4, an endoscope probe, a water pipeline 5 and a gas pipeline 6, wherein the water filling pipeline 1 comprises an upper part 1-1 and a lower part 1-2, the material of the upper part 1-1 is higher in rigidity than that of the lower part 1-2, and the material of the lower part 1-2 is a flexible material; the outer side surface of the lower part 1-2 of the water filling pipeline 1 is provided with a convex ring 1-3; the upper surface of the convex ring 1-3 supports an elastic body 4, the lower surface of the elastic body 4 is supported on the upper surface of the convex ring 1-3, the elastic body 4 is a cylindrical spring, and the cylindrical spring is nested on the outer side surface of the lower part 1-2 of the water filling pipeline 1; the upper surface of the piezoelectric sensor 3 is fixedly provided with an inflation pipeline 2, and the inflation pipeline 2 comprises an inflation cushion 2-2 which is fixedly arranged on the upper surface of the piezoelectric sensor 3 and is fixedly nested on the outer side surface of the upper part 1-1 of the inflation pipeline 1.

Further, the convex ring 1-3 extends from the outer surface of the lower portion 1-2 to the outside.

Further, the collars 1-3 include a plurality of discontinuous bosses.

Further, water route 5 has still been connected to water filling pipeline 1, and it has oral siphon, outlet pipe, intake pump, water source reinforce, drain pump etc to can realize water injection and drainage to water filling pipeline 1.

Further, the upper portion of inflatable cushion 2-2 has a diameter that decreases as the height increases.

Further, an inflation channel 2-1 is eccentrically provided at one side of the annular inflatable cushion 2-2.

Further, the inflation channel 2-1 is used for introducing gas into the annular inflatable cushion 2-2; the inflation channel 2-1 is connected with a gas circuit 6, and the gas circuit is provided with a barometer 6-1, a gas source 6-2, a pump and a gas exhaust pipeline.

Further, an endoscope probe is arranged on the upper surface of the annular inflatable cushion 2-2.

Furthermore, a guide wire cavity and a guide wire are also arranged in the balloon dilator for the cricopharyngeal muscle, and the guide wire cavity can be arranged in parallel with the water filling pipeline 1.

A control method of the balloon dilator for the circumpharyngeal muscle is characterized in that: the method comprises the following steps:

step 1, guiding a balloon dilator of the cricopharyngeal muscle into the throat part of a patient;

step 2, inflating air into the inflation pipeline 2-1 to enable the annular inflatable cushion 2-2 to be full of air and to be in a full state;

step 3, filling liquid into the lower part 1-2 of the water filling pipeline 1, and gradually expanding the lower part 1-2 of the water filling pipeline 1 from the bottom to the outer side under the action of gravity along with the filling of the liquid; pushing the pressure sensor 3 and the annular inflatable cushion 2-2 to move upwards. The annular inflatable cushion 2-2 gradually extends into the narrow part of the cricopharyngeal muscle;

and 4, detecting and controlling the air pressure monitoring value of the annular inflatable cushion 2-2 and the pressure monitoring value of the piezoelectric sensor 3.

The balloon dilator for the cricopharyngeal muscle provided by the invention has the following beneficial effects: 1) the problem that the spasm of the cricopharyngeal muscle is aggravated and the treatment effect is poor due to the fact that the spastic cricopharyngeal muscle is stimulated by the conventional cricopharyngeal muscle balloon dilator to perform balloon dilatation through pulling the catheter filled with water is avoided; causing edema and bleeding of the esophagus and throat mucosa; 2) the tension expansion degree can be accurately monitored in real time through sensors such as a piezoelectric sensor and a barometer, muscle expansion can be scientifically carried out, and the treatment effect is improved.

Drawings

Fig. 1 is a schematic structural diagram of the balloon dilator for the cricopharyngeal muscle provided by the invention.

FIG. 2 is a view of the inflated circular cushion of the balloon dilator for the cricopharyngeal muscle in an embodiment of the invention shown in a fully inflated state.

FIG. 3 is a view of the lower fluid-filled state of the balloon dilator for the cricopharyngeal muscle in an embodiment of the invention.

Detailed Description

The present invention will now be described in more detail with reference to the accompanying drawings, in which preferred embodiments of the invention are shown, it being understood that one skilled in the art may modify the invention herein described while still achieving the beneficial results of the present invention. Accordingly, the following description should be construed as broadly as possible to those skilled in the art and not as limiting the invention.

In the interest of clarity, not all features of an actual implementation are described. In the following description, well-known functions or constructions are not described in detail since they would obscure the invention in unnecessary detail. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific details must be set forth in order to achieve the developer's specific goals.

In order to make the objects and features of the present invention more comprehensible, embodiments of the present invention are described in detail below with reference to the accompanying drawings. It is to be noted that the drawings are in a very simplified form and are intended to use non-precision ratios for the purpose of facilitating and clearly facilitating the description of the embodiments of the invention.

This embodiment provides a balloon dilator for the circumpharyngeal muscle, as shown in fig. 1, the balloon dilator for the circumpharyngeal muscle at least includes: water filling pipeline 1, air filling pipeline 2, piezoelectric sensor 3, spring 4, endoscope probe, water route 5 and gas route 6.

Wherein the water-filled pipe 1 comprises an upper part 1-1 and a lower part 1-2, wherein the material of the upper part 1-1 is more rigid than the material of the lower part 1-2, and the material of the lower part 1-2 is a flexible material. So that after the liquid is injected into the water filling line 1, the liquid is concentrated in the lower part 1-2 due to gravity, so that the lower part 1-2 of the water filling line 1 can be expanded outward by the liquid tension, as shown in the lower part 1-2 of fig. 3, while the upper part 1-1 can keep the upper material from being expanded outward substantially because the material has a certain rigidity.

Preferably, the water-filled line 1 has a diameter of about 0.5-0.7cm in the uninflated and filled initial state, so as to conveniently extend into the esophagus. Preferably, the lower portion 1-2 of the water charging line 1 may be slightly thicker in diameter than the upper portion 1-1, and preferably may be 5-8mm larger in diameter than the upper portion 1-1.

The outer side surface of the lower part 1-2 of the water filling pipeline 1 is provided with a convex ring 1-3, the convex ring 1-3 extends outwards from the outer surface of the lower part 1-2 for a certain length, and the convex ring 1-3 can be replaced by a plurality of discontinuous bosses.

The water filling pipeline 1 is also connected with a water channel 5 which is provided with a water inlet pipe, a water outlet pipe, a water inlet pump, a strong water source, a drainage pump and the like, so that water injection and drainage can be realized on the water filling pipeline 1.

The upper surface of the convex ring 1-3 supports an elastic body 4, the lower surface of the elastic body 4 is supported on the upper surface of the convex ring 1-3, the elastic body 4 is a cylindrical spring, the cylindrical spring is nested on the outer side surface of the lower part 1-2 of the water filling pipeline 1, the difference between the inner diameter of the cylindrical spring and the outer diameter of the lower part 1-2 is 1-2mm, if the difference is too large, the spring is not sensitive enough to the expansion response (namely, upward compression) of the lower part 1-2, and if the difference is too small, the spring is easy to clamp on the outer side of the lower part 1-2 and is difficult to move.

The piezoelectric sensor 3 is ring-shaped and is fixedly installed on the upper part 1-1 of the water filling pipeline 1, the lower surface of the piezoelectric sensor 3 is fixedly connected with the upper surface of the elastic body 4 (cylindrical spring), and the distance between the convex ring 1-3 and the piezoelectric sensor 3 is the length of the elastic body 4 in a natural (i.e. unstressed) state. The piezoelectric sensor 3 is further equipped with necessary matching devices such as an output electrode and a signal line, and the lines such as the signal line can be configured through a signal line circuit configured separately, and a person skilled in the art can know the setting method thereof, and details are not described herein.

The upper surface of the piezoelectric sensor 3 is fixedly provided with an inflation pipeline 2, and the inflation pipeline 2 comprises an inflation cushion 2-2 which is fixedly arranged on the upper surface of the piezoelectric sensor 3 and is fixedly nested on the outer side surface of the upper part 1-1 of the inflation pipeline 1.

The inflatable cushion 2-2 is a ring-shaped inflatable cushion, the upper part of the inflatable cushion 2-2 has a diameter which is reduced along with the increase of the height, namely the upper part of the inflatable cushion 2-2 is in a pointed shape, so that the inflatable cushion 2-2 has a contact surface which gradually increases the tension when applying the tension to the cricopharyngeal muscle, and further avoids the damage of the sudden change of the tension applied to the muscle and the mucosa.

An inflation channel 2-1 is eccentrically arranged at one side of the annular inflatable cushion 2-2, and the inflation channel 2-1 is used for introducing air into the annular inflatable cushion 2-2. The inflation channel 2-1 is connected with an air path 6 which is provided with necessary equipment such as a barometer 6-1, an air source 6-2, a pump, an exhaust pipeline and the like, so that inflation and exhaust of the inflation pipeline can be realized.

An endoscope probe is also arranged near the upper surface of the annular inflatable cushion 2-2 and is arranged on the upper surface of the annular inflatable cushion 2-2 through an endoscope pipeline, so that the position of the annular inflatable cushion 2-2 in human tissues can be monitored in real time. The manner in which the endoscopic probe is disposed in the insertion catheter is well known to those skilled in the art and therefore will not be described in detail herein.

As the length of the circumpharyngeal muscle is 3-5cm, and the length of the annular inflatable cushion 2-2 is more than 5cm, preferably 5-10cm, the inflatable cushion can be in full contact with the circumpharyngeal muscle.

The length of the lower portion 1-2 of the water-filled pipe 1 is preferably 5-8cm so as to enable better compression of the elastomer and the air-filled cushion.

Preferably, the annular inflatable cushion 2-2 may further have a plurality of strain test points or pressure test points disposed on the surface thereof so as to control the stress of the annular inflatable cushion 2-2.

It should be noted that fig. 1 highlights the specific structure of each part for better illustration of the structure, but in practice fig. 1 illustrates only the front part of the balloon dilator of the cricopharyngeal muscle, which has an overall shape of a slender tube for penetration into the throat.

In addition, the sensors such as the endoscope probe, the piezoelectric sensor and the barometer used in the balloon dilator for the cricopharyngeal muscle are connected to an external control computer through signal lines, data lines or wireless modes, so that sensor data or monitoring images can be obtained in real time.

The balloon dilator for the cricopharyngeal muscle is further provided with the guide wire cavity and the guide wire, so that the tubular dilator can be deeply guided into the digestive tract. The guidewire lumen may be placed in parallel with the water fill line 1 to provide the necessary support during introduction.

The balloon dilator for the cricopharyngeal muscle provided by the present application is made of a material which is suitable for contacting the internal tissue of the human body and has a certain elasticity, such as a silicone material, and preferably, the deformable portion (such as the inflatable cushion or the lower portion of the inflation tube 1) can have a thinner sidewall thickness than the other portion (such as the lower portion of the inflation tube), thereby facilitating the deformation of the specific portion or the shape maintenance. The material of the elastic body 4 may be titanium alloy or other bio-contactable elastic plastic or resin.

The control method of the cricopharyngeal muscle ball dilator provided by the present application is described below.

The operation method may include:

step 1, guiding the balloon dilator of the cricopharyngeal muscle in an original state (figure 1) into the throat part of a patient, starting an endoscope probe, transmitting a real-time image on an external control computer through the endoscope probe for monitoring, and stopping guiding downwards when the endoscope probe just passes through the stenosis part of the cricopharyngeal muscle, namely when the annular inflatable cushion 2-2 passes through the stenosis part of the cricopharyngeal muscle and is adjacent to the lower end of the stenosis part of the cricopharyngeal muscle.

Specifically, the introduction mode may be an endoscopic automatic transport apparatus known in the art, or may be a manual introduction.

And 2, inflating air into the inflation pipeline 2-1 through the air passage 6 to ensure that the annular inflatable cushion 2-2 is filled with air and is in a full state (shown in figure 2), wherein the uppermost end of the filled annular inflatable cushion 2-2 is positioned at the lower end of the stenotic portion of the cricopharyngeal muscle or positioned above the lower end of the stenotic portion of the cricopharyngeal muscle. Since the annular inflatable cushion 2-2 is located at the above position, the tip portion of the annular inflatable cushion 2-2 cannot move upward without applying an external force because the narrow pharyngolaryngeal muscle passage is restricted at the lower end of the narrow portion of the pharyngolaryngitis. The pressure in the gas-filled conduit 2-1 is monitored by a barometer 6-1, at a pressure value of P1, preferably P1 of 1.5-2 atmospheres.

And 3, as shown in fig. 3, filling liquid into the lower part 1-2 of the water filling pipeline 1 through the water channel, and gradually expanding the lower part 1-2 of the water filling pipeline 1 from the bottom to the outside under the action of gravity along with the filling of the liquid, as shown in fig. 3. As the lower part 1-2 expands towards the outside, the bottom of the elastic body 4 nested on the outside of the lower part 1-2 moves upwards along the outer surface of the lower part of the water filling pipe 1, while the top of the elastic body 4 is limited at the lower end of the narrow part of the cricopharyngeal muscle due to the annular inflatable cushion 2-2, the length of the elastic body 4 is compressed, and the elastic body 4 applies pressure to the piezoelectric sensor 3, which generates a pressure electric signal on one hand and pushes the pressure sensor 3 and the annular inflatable cushion 2-2 upwards on the other hand. The annular inflatable cushion 2-2 gradually penetrates into the narrow part of the cricopharyngeal muscle.

And 4, with the lower part 1-2 being continuously filled with liquid, the annular inflatable cushion 2-2 gradually extends into the narrow part of the cricopharyngeal muscle, and the air pressure in the annular inflatable cushion 2-2 and the pressure value of the piezoelectric sensor 3 are monitored. Firstly, detecting an air pressure monitoring value of the annular inflatable cushion 2-2, and when the air pressure monitoring value is larger than an air pressure threshold value, preferably the air pressure threshold value is 2.5P1, exhausting the annular inflatable cushion 2-2, and controlling the air pressure of the annular inflatable cushion 2-2 to be lower than 2.5P 1; when the pressure of the annular inflatable cushion 2-2 is below 2.5P1, the pressure monitoring value of the pressure sensor 3 is monitored, and when the pressure monitoring value is greater than a pressure threshold (preferably, the pressure threshold may be 800 plus 1000N), which indicates that the annular pharyngeal muscle is too stressed to allow the inflatable cushion to pass further, the gas in the annular inflatable cushion 2-2 is further exhausted until the pressure monitoring value is less than the pressure threshold, so as to reduce the deep resistance of the annular inflatable cushion 2-2 to the stenosis. If the gas is exhausted from annular inflatable cushion 2-2 until the monitored gas pressure is less than 1.5P1 and the monitored pressure has not dropped below the threshold pressure, indicating that a spasm in the cricopharyngeal muscle has no longer been effectively dilated, the dilatation is stopped, the gas in annular inflatable cushion 2-2 and the liquid in lower portion 1-2 are evacuated to restore the dilator to its original state (FIG. 1), and step 1 is repeated.

And 5, when the air pressure value of the annular inflatable cushion 2-2 is suddenly changed to P1 or is basically equal to P1 in the pushing process, and the pressure value of the pressure sensor 3 is also suddenly changed to 0N or is close to 0N, such as 50-0N, the annular inflatable cushion 2-2 completely passes through the narrow part, and one expansion action is completed. The annular inflatable cushion 2-2 can be evacuated of gas and liquid from the lower portion 1-2 to restore the expander to its original state (fig. 1) and step 1 repeated.

In the description of the present invention, it is to be understood that the terms "upper", "lower", "vertical", "top", "bottom", "inner", "outer", "front", "rear", "left", "right", and the like, indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention.

The foregoing illustrates and describes the principles, general features, and advantages of the present invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. A balloon dilator for the circumpharyngeal muscle, which is characterized in that: this circumpharyngeal muscle balloon dilator includes at least: the endoscope probe comprises a water filling pipeline (1), a gas filling pipeline (2), a piezoelectric sensor (3), a spring (4), an endoscope probe, a water path (5) and a gas path (6), wherein the water filling pipeline (1) comprises an upper part (1-1) and a lower part (1-2), the upper part (1-1) is made of a material with higher rigidity than that of the lower part (1-2), and the lower part (1-2) is made of a flexible material; a convex ring (1-3) is arranged on the outer side surface of the lower part (1-2) of the water filling pipeline (1); the upper surface of the convex ring (1-3) supports an elastic body (4), the lower surface of the elastic body (4) is supported on the upper surface of the convex ring (1-3), the elastic body (4) is a cylindrical spring which is nested on the outer side surface of the lower part (1-2) of the water filling pipeline (1); the upper surface of the piezoelectric sensor (3) is fixedly provided with an inflation pipeline (2), and the inflation pipeline (2) comprises an inflation cushion (2-2) which is fixedly arranged on the upper surface of the piezoelectric sensor (3) and is fixedly nested on the outer side surface of the upper part (1-1) of the inflation pipeline (1).

2. The balloon dilator of the cricopharyngeal muscle according to claim 1, wherein: the convex ring (1-3) extends outward from the outer surface of the lower part (1-2).

3. The balloon dilator of the cricopharyngeal muscle according to claim 1, wherein: the raised ring (1-3) comprises a plurality of discontinuous bosses.

4. The balloon dilator of the cricopharyngeal muscle according to claim 1, wherein: water filling pipeline (1) has still connected water route (5), and it has oral siphon, outlet pipe, intake pump, water source are strong, drain pump etc to can realize water injection and drainage to water filling pipeline (1).

5. The balloon dilator of the cricopharyngeal muscle according to claim 1, wherein: the upper portion of the inflatable cushion (2-2) has a diameter that decreases with increasing height.

6. The balloon dilator of the cricopharyngeal muscle according to claim 1, wherein: an inflation channel (2-1) is eccentrically arranged at one side of the annular inflatable cushion (2-2).

7. The balloon dilator of the cricopharyngeal muscle according to claim 6, wherein: the inflation channel (2-1) is used for introducing gas into the annular inflation cushion (2-2); the inflation channel (2-1) is connected with a gas circuit (6) which is provided with a barometer (6-1), a gas source (6-2), a pump and a gas exhaust pipeline.

8. The balloon dilator of the cricopharyngeal muscle according to claim 7, wherein: an endoscope probe is also arranged on the upper surface of the annular inflatable cushion (2-2).

9. The balloon dilator of the cricopharyngeal muscle according to claim 1, wherein: the balloon dilator for the cricopharyngeal muscle is also provided with a guide wire cavity and a guide wire, and the guide wire cavity can be arranged in parallel with the water filling pipeline (1).