阅读说明：本技术 针对贲门失弛缓症自适应渐进式扩张器及其制备方法 (Self-adaptive progressive dilator for achalasia of cardia and preparation method thereof ) 是由 关国平 王璐 王富军 林婧 于 2020-02-10 设计创作，主要内容包括：本发明涉及一种针对贲门失弛缓症的自适应渐进式扩张器及其制备方法,将成型后的圆筒状形状记忆材料套在阳模上,再在扩张器的外表面套上阴模,通过定型制得针对贲门失弛缓症的自适应渐进式扩张器；制得的自适应渐进式扩张器为贲门失弛缓症治疗模型的放大件；所述贲门失弛缓症治疗模型为壁厚均匀的空心结构,其外部形状和尺寸与贲门失弛缓症治疗部位内腔的形状和尺寸相同；所述放大是指保持轴向尺寸不变,径向尺寸等比例放大；所述贲门失弛缓症治疗部位包括贲门以及与贲门相连的食管下端和胃上端；自适应渐进式扩张器单位长度上的径向支撑力为0.5～15N/mm。本发明的自适应渐进式扩张器可用于治疗贲门失弛缓症,效果显著且没有创伤。(The invention relates to a self-adaptive progressive dilator for achalasia of cardia and a preparation method thereof, wherein a formed cylindrical shape memory material is sleeved on a male die, a female die is sleeved on the outer surface of the dilator, and the self-adaptive progressive dilator for achalasia of cardia is prepared by shaping; the prepared adaptive progressive dilator is an amplifying piece of a cardia achalasia treatment model; the cardia achalasia treatment model is a hollow structure with uniform wall thickness, and the external shape and the size of the model are the same as those of the inner cavity of the cardia achalasia treatment part; the amplification means that the axial size is kept unchanged, and the radial size is amplified in equal proportion; the achalasia treatment part comprises a cardia, and a lower esophagus end and an upper stomach end which are connected with the cardia; the radial supporting force of the self-adaptive progressive expander in unit length is 0.5-15N/mm. The adaptive progressive dilator can be used for treating achalasia of cardia, and has remarkable effect and no wound.)

1. An adaptive progressive dilator aiming at achalasia of cardia is characterized in that: is an enlargement part of a cardia achalasia treatment model; the cardia achalasia treatment model is a hollow structure with uniform wall thickness, and the external shape and the size of the model are the same as those of the inner cavity of the cardia achalasia treatment part; the amplification means that the axial size is kept unchanged, and the radial size is amplified in equal proportion; the achalasia treatment part comprises a cardia, and a lower esophagus end and an upper stomach end which are connected with the cardia;

the self-adaptive progressive dilator is made of a shape memory material, and the radial supporting force of the self-adaptive progressive dilator in unit length is 0.5-15N/mm.

2. The adaptive progressive dilator for achalasia according to claim 1, wherein the enlargement is a 20-100% enlargement.

3. The adaptive progressive dilator for achalasia according to claim 1 or 2, characterized in that the shape memory material is a shape memory polymer material or a shape memory alloy.

4. The adaptive progressive dilator for achalasia according to claim 3, wherein the shape memory polymer material is P L A, PC L or PU and the shape memory alloy is Nitinol.

5. The adaptive progressive dilator for achalasia according to claim 1 or 2, wherein the wall of the adaptive progressive dilator is porous structure with porosity of 40-80%.

6. The adaptive progressive dilator for achalasia according to claim 5, wherein the wall of the adaptive progressive dilator has a thickness of 0.1-0.5 mm.

7. The method for preparing an adaptive progressive dilator for achalasia according to claim 1 or 2, wherein: sleeving a formed cylindrical shape memory material on a male die, sleeving a female die on the outer surface of the dilator, and shaping to obtain the self-adaptive progressive dilator aiming at achalasia of cardia; the male die and the female die are of a concave-convex matching structure.

8. The method of preparing an adaptive progressive dilator for achalasia according to claim 7, wherein the shaping method is laser engraving, braiding or welding.

9. The method for preparing an adaptive progressive dilator for achalasia according to claim 8, wherein when laser engraving is used, holes are drilled on the tube by laser; when the weaving forming is adopted, holes are naturally formed; when the welding forming is adopted, the distance between adjacent wires or plates is 1-10 mm.

10. The method of preparing an adaptive progressive dilator for achalasia according to claim 7, wherein the sizing is heat sizing.

Technical Field

The invention belongs to the technical field of medical instruments, and relates to a self-adaptive progressive dilator for achalasia of cardia and a preparation method thereof.

Background

Cardia achalasia, also known as cardia spasm, is a disease in which dysfunction of the neuromuscular function of the cardia causes achalasia of the cardia sphincter, and food is retained without passing through it, thereby gradually increasing the tension of the esophagus, decreasing peristalsis, and dilating the esophagus. The clinical manifestations are dysphagia, pain after sternum, food reflux, cough caused by food reflux and aspiration into trachea, lung infection and other symptoms. Although achalasia is not common, the cardia is hidden and gradually progresses, and the clinical findings usually exist for years.

Achalasia of the cardia can be classified into two types, primary (idiopathic) and secondary. The primary achalasia is not clear in etiology, and probably is a cardiac neuron degeneration caused by self-heredity, immunity and other factors. Secondary achalasia may be caused by other esophageal motor disorders such as trypanosomiasis, neurofibromatosis, eosinophilic esophagitis, juvenile sicca syndrome, and the like.

The hazards associated with achalasia are also apparent. Swallowing difficulty when eating solid or liquid food, reflux of non-acidic undigested food, feeling of fullness after sternum, even burning sensation, distending pain, and long-term singultus. Aspiration due to reflux of retention in the esophagus (especially in a lying position) can be repeated with lung infection (cough, expectoration, fever, etc.). Some patients may experience poststernal pain and heartburn, which is more common than younger patients. Moreover, because the disease is hidden, the disease condition gradually progresses, and early symptoms lack specificity, and the disease is relatively rare, the disease is often treated as other diseases before the diagnosis is confirmed, so that misdiagnosis and delayed disease condition are caused, for example, misdiagnosis is gastroesophageal reflux disease or malignant tumor.

The treatment of achalasia of the cardia can generally be divided into three main categories: (I) drug treatment: nitroglycerin, isosorbide dinitrate, nifedipine, etc. can relax the sphincter, but up to over 30% of patients may experience side effects such as hypotension. Moreover, most are tolerated over a period of weeks, so that medication is currently only applied to patients who are not suitable for endoscopic or surgical treatment, and long-term administration is required. (II) endoscope treatment: including endoscopic balloon dilatation and oral endoscopic sphincterotomy (POEM), both of which are based on mechanical disruption of the cardiac sphincter. The endoscopic treatment has the defects that the scope and the degree of the expansion and incision under the endoscope are difficult to control, the curative effect is influenced if the scope is insufficient, and serious complications such as gastroesophageal perforation, bleeding and the like are easy to occur if the scope is too large. (III) surgical treatment: currently, the most common procedure is laparoscopic sphincterotomy, which has definite effect, but may have complications such as gastroesophageal reflux disease, esophageal perforation, hemorrhage and the like.

All the treatments described above aim to reduce the resting pressure of the cardiac sphincter to a level at which "uptake passage is no longer impeded", but none of them restore normal oesophageal function, only leading to symptomatic improvement. In addition, the effect of the treatment diminishes over time, so that the patient needs a long follow-up and often receives repeated or other treatments.

Patients with cardia achalasia may develop progressive esophageal dilatation if treatment is suboptimal, with advanced or terminal cardia achalasia characterized by esophageal tortuosity, angulation and severe dilatation or giant esophagus (diameter >6 cm). Between 10% and 15% of patients who have undergone treatment for achalasia develop advanced or terminal achalasia, and as many as 5% may require esophagectomy with more serious consequences.

Therefore, it is of great importance to develop a more simple and effective treatment of achalasia without trauma.

Disclosure of Invention

The invention provides a self-adaptive progressive dilator aiming at achalasia of cardia and a preparation method thereof, and aims to solve the problems in the prior art. The invention innovatively provides an advanced dilator for noninvasive treatment, which can be perfectly matched with the form of a pathological change part in a self-adaptive manner, can provide controllable and progressive dilating force aiming at cardia sphincter spasm, and can perform progressive dilation on the sphincter to finally open the sphincter in an adaptive manner until the tissue structure of the pathological change part is recovered to be normal and cardia achalasia is relieved and cured. The treatment method has no wound, instant effect and simple and convenient operation, avoids repeated and long-term treatment, relieves the pain of patients, saves time and a large amount of medical resources, overcomes the defects of the three common clinical treatment methods at present, and has very wide application prospect.

The invention relates to a self-adaptive progressive dilator aiming at achalasia of cardia and a preparation method thereof, wherein the self-adaptation is realized through the high flexibility and the high elasticity of the dilator, and the progressive dilator is realized through the self-expansion performance, the high elasticity and the shape memory performance of the dilator. Specifically, first, the size of the dilator is larger than the size of the implantation site; secondly, the dilator is flexible and can be perfectly matched with the structure of an implantation part; thirdly, with the opening of the lesion cardia, the dilator can be gradually and adaptively expanded, and finally, the complete restoration of the lesion part is realized.

In order to achieve the purpose, the technical scheme adopted by the invention is as follows:

an adaptive progressive dilator aiming at achalasia of cardia is an amplifying piece of a treatment model of achalasia of cardia; the cardia achalasia treatment model is a hollow structure with uniform wall thickness, and the external shape and the size of the model are the same as those of the inner cavity of the cardia achalasia treatment part; the amplification means that the axial size is kept unchanged, and the radial size is amplified in equal proportion (the inner diameter and the outer diameter are amplified in equal proportion, and the equal proportion refers to that the amplification proportion of each part is equal); the treatment part of the achalasia of cardia comprises the cardia and the lower end and the upper end of the esophagus connected with the cardia, and the size of the lower end and the upper end of the esophagus connected with the cardia in the treatment part is determined according to the condition of the lesion part of a specific patient;

the adaptive progressive dilator comprises an integrally formed esophagus part, a cardiac part and a stomach; the esophagus part, the cardia part and the stomach are sequentially connected; the straw part is of an irregular cylindrical structure, and the irregular cylinder has the characteristics of large middle and small two ends; the cardia part is of a cylindrical structure; the stomach is in a horn-shaped structure;

the self-adaptive progressive dilator is made of a shape memory material, has shape memory performance, good rebound resilience and low plastic deformation rate, can be naturally and slowly unfolded after being compressed, and can be restored to an initial state; the adaptive progressive dilator has controllable radial support strength (which can be specifically regulated and controlled by material selection and matching, selection of a processing mode, adjustment of parameters such as dilator size, wall thickness and porosity and the like), and the radial support force per unit length of the dilator is 0.5-15N/mm (the test method refers to an article Optimal radial force and size for vibration in organic chemistry and engineering, scientific Endocopopy, 2017).

Generally, when the structure, the process and the wire diameter are the same, the radial support strength of the metal dilator is higher than that of the high polymer material, and the support strength of the dilator obtained by the laser engraving method is higher than that of the dilator obtained by the weaving method. When the dilator is compressed to the same size, the supporting force of the dilator with the large size is larger than that of the dilator with the small size, the wall thickness is positively correlated with the supporting strength, and the porosity is negatively correlated with the supporting strength.

As a preferred technical scheme:

the adaptive progressive dilator aiming at achalasia of cardia is characterized in that the amplification is 20-100%.

The adaptive progressive dilator for achalasia of cardia as described above, wherein the shape memory material is a shape memory polymer material or a shape memory alloy; the shape memory polymer material or the shape memory alloy can be a wire or a pipe.

The adaptive progressive dilator for achalasia of cardia as described above, the shape memory polymer material is P L A, PC L or PU, the shape memory polymer material includes but is not limited to these, other kinds of shape memory polymer materials are also within the scope of the present invention, the shape memory alloy is nitinol, the shape memory alloy includes but is not limited to this, and other kinds of shape memory alloys are also within the scope of the present invention.

The self-adaptive progressive dilator aiming at achalasia of cardia is characterized in that the wall of the self-adaptive progressive dilator is of a porous structure, and the porosity is 40-80%; the porous structure of the dilator wall is beneficial to the embedding of the soft tissue of the organ cavity surface, greatly increases the friction force and plays an excellent anti-skid function. The porosity is too high, and the support force of the bracket is low; the porosity is too low, the anti-slip performance is low, the volume of the dilator is large, and the dilator is not easy to compress and convey.

The adaptive progressive dilator for the achalasia of cardia has the thickness of the wall of the adaptive progressive dilator being 0.1-0.5 mm.

The invention also provides a method for preparing the self-adaptive progressive dilator for the achalasia, which comprises the steps of sleeving the formed cylindrical shape memory material on a male die, sleeving a female die on the outer surface of the dilator, and shaping to obtain the self-adaptive progressive dilator for the achalasia; the male die and the female die are of a concave-convex matching structure.

As a preferred technical scheme:

the method for preparing the adaptive progressive dilator for achalasia of cardia as described above, the forming method is laser engraving, weaving or welding, the forming method of the invention includes but is not limited thereto, and other reasonable forming methods are also within the scope of the invention.

According to the preparation method of the self-adaptive progressive dilator for achalasia of cardia, when laser engraving molding is adopted, holes are drilled on the tube by laser; the structure obtained by the weaving process is a natural porous structure; when the welding forming is adopted, the distance between adjacent wires or plates is 1-10 mm. The method for obtaining the porous structure by laser engraving is to use laser to punch holes on the pipe; the structure obtained by the weaving process is a natural porous structure; the method for obtaining the porous structure through welding is to connect wires or plates according to a certain arrangement mode, and the distance of 1-10 mm is reserved between every two adjacent wires.

The method for preparing the adaptive progressive dilator for achalasia as described above is heat setting, and the means for setting includes, but is not limited to, heat setting, and other reasonable setting means are also suitable for the present invention.

The self-adaptive progressive dilator aiming at the achalasia is placed at a diseased region (a region for treating the achalasia) through a conveying device, and during the conveying process, the dilator is firstly compressed and loaded into the conveying device and released after reaching a desired region, and the diseased region is supported by utilizing the self-expansion (shape memory) performance of the dilator.

The self-adaptive progressive dilator for achalasia of cardia has an excellent anti-slip mechanism. On one hand, the middle of the esophagus part of the dilator is large, the two ends of the esophagus part are small, the shape of the dilator is completely matched with the shape of the lower end of the esophagus, and the dilator has excellent performance of preventing downward slippage; on the other hand, the porous structure of the dilator wall is beneficial to the embedding of the soft tissue of the organ cavity surface, greatly increases the friction force and plays an excellent anti-skid function.

Has the advantages that:

(1) the self-adaptive progressive dilator for treating achalasia of cardia is a medical instrument for treating achalasia of cardia noninvasively, is simple and convenient to operate, obvious in effect, free of obvious complications and free of long-term repeated operation, relieves pain of patients, saves time and medical cost of the patients, and saves a large amount of public medical resources;

(2) the self-adaptive progressive dilator for achalasia of cardia is simple in structure, convenient to convey and mature in technology;

(3) the self-adaptive progressive dilator for achalasia of cardia has better anti-slipping performance at an acting part;

(4) the self-adaptive progressive dilator aiming at achalasia of cardia is high in flexibility and elasticity and has a shape memory function, so that the dilator can be perfectly matched with the structure of a treatment part in a self-adaptive mode, and the achalasia of cardia can be progressively dilated.

(5) The preparation method of the self-adaptive progressive dilator for achalasia of cardia, which is disclosed by the invention, is simple in processing technology and lower in cost.

Drawings

FIG. 1 is a schematic pre-implantation adaptive progressive dilator for achalasia by weaving;

FIG. 2 is a schematic diagram of an adaptive progressive dilator for achalasia according to the prior art obtained by laser engraving;

FIG. 3 is a schematic diagram of an adaptive progressive dilator for achalasia by welding before implantation;

fig. 4 is a schematic diagram of an adaptive progressive dilator post-implantation for achalasia.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the teaching of the present invention, and such equivalents may fall within the scope of the present invention as defined in the appended claims.

An adaptive progressive dilator aiming at achalasia of cardia is an amplifying piece of a treatment model of achalasia of cardia; the cardia achalasia treatment model is a hollow structure with uniform wall thickness, and the external shape and the size of the model are the same as those of the inner cavity of a cardia achalasia treatment part (the cardia achalasia treatment part comprises the cardia and the lower end and the upper end of the stomach connected with the cardia); the amplification means that the axial size is kept unchanged, and the radial size is amplified by 20-100% in an equal proportion; the self-adaptive progressive dilator is made of shape memory materials (shape memory high polymer materials or shape memory alloys), the wall of the dilator is of a porous structure, the porosity is 40-80%, and the thickness of the wall of the dilator is 0.1-0.5 mm; the radial supporting force of the self-adaptive progressive expander in unit length is 0.5-15N/mm.

The preparation method of the self-adaptive progressive dilator aiming at achalasia of cardia comprises the following steps: the self-adaptive progressive dilator aiming at the achalasia of cardia is prepared by sleeving a cylindrical shape memory material formed by laser engraving, weaving or welding (when the laser engraving is adopted, holes are drilled on a pipe by laser, when the weaving is adopted, natural holes are formed on the wall of the pipe, and when the welding is adopted, the distance between adjacent wires is 1-10 mm) on a male die, sleeving a female die on the outer surface of the dilator (the male die and the female die are in a concave-convex matching structure), and performing heat setting.