Tracheal dilation device and its preparation method

Abstract

Embodiments of the present disclosure provide a tracheal dilation device and a preparation method thereof. The device includes: a body having a C-shaped structure, the body being provided with a hole; a pulling wire, one end of which passes through and is fixed in the hole; wherein the body is configured to be disposed around the outer periphery of the trachea, and the other end of the pulling wire is fixed to the adventitia of the trachea, and the body applies an outward expanding traction force to the adventitia of the trachea via the pulling wire. The tracheal dilation device and the preparation method thereof provided by the embodiments of the present disclosure can fix the body to the outer periphery of the trachea and surround the trachea via the pulling wire, and one end of the pulling wire is fixed to the adventitia of the trachea, and the other end passes through and is fixed in the hole, so that the body can apply an outward expanding traction force to the trachea via the pulling wire, realizing the outward expansion and fixation of the trachea. Since one end of the pulling wire is fixed to the adventitia of the trachea, the inner diameter of the trachea can be increased without damaging the inner membrane of the trachea, realizing the expansion of the trachea.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices, and more particularly, to a tracheal dilation device and a preparation method thereof. Background Art

[0002] Congenital Heart Disease (CHD) is one of the most common congenital malformations in children, with a worldwide incidence of 5-8 per thousand. With the continuous progress of prenatal diagnosis, intensive care level and pediatric cardiac surgery technology, the incidence of related complications and mortality of CHD have been well controlled, and CHD is no longer regarded as a fatal disease. However, when children with CHD are combined with primary tracheal stenosis (CTS) or tracheomalacia (TM), the mortality and complication incidence of CHD treatment will increase significantly, seriously affecting the quality of the newly born population and increasing the national medical burden. The treatment of CTS and TM combined with congenital heart disease has always been a clinical difficulty, and the current treatment methods include tracheal stenting and tracheal exclusion.

[0003] Among them, tracheal stenting usually supports and expands the tracheal intima through metal stents, plastic stents or silicone stents. Although the mesh structure of metal stents has the advantages of not affecting tracheal ciliary movement, large diameter, thin tube wall and not easy to displace, it is very easy to form granulation tissue to block the airway, easy to invade the bronchial wall and difficult to remove, and easy to break resulting in tracheal fistula. Plastic and silicone tracheal stents are the most widely used, with good tissue compatibility and not easy to grow granulation tissue, but the available stent models are limited (usually large stents), easy to deform, easy to displace, affect ciliary movement and easy to block. At present, after the application of composite materials, less tracheal granulation tissue hyperplasia occurs and the ciliary activity is less affected, but such stents have high requirements for instruments and cannot be applied to small infants and young children for the time being; while degradable stents are easy to curl, have a limited support time (about 6-7 weeks), and are easy to block the airway after degradation.

[0004] Tracheal exclusion cannot completely improve tracheal stenosis, and it is very likely to have recurrent pulmonary infections, hypoxemia and inability to wean from the ventilator after the operation. For children with tracheal compression or still relatively severe tracheomalacia, tracheal exclusion conservative treatment is performed, and the postoperative related complications and ventilator use time are significantly increased, and the mortality rate is significantly increased.

[0005] Therefore, there is provided a tracheal dilation device and a preparation method thereof, which can accurately dilate and fix the tracheal adventitia, increase the tracheal inner diameter without damaging the tracheal intima, and can be applied to the treatment of primary tracheal stenosis combined with congenital heart disease to relieve tracheal stenosis.

[0006] It should be noted that the information disclosed in the above background art section is only used to enhance the understanding of the background of the present disclosure, and thus may include information that does not constitute the prior art known to those of ordinary skill in the art. Summary of the Invention

[0007] The embodiments of the present disclosure provide a tracheal dilation device and a preparation method thereof, which can accurately dilate and fix the tracheal adventitia to at least a certain extent, increase the tracheal inner diameter without damaging the tracheal intima, and can be applied to the treatment of primary tracheal stenosis and tracheomalacia complicated with congenital heart disease to relieve tracheal stenosis.

[0008] Other features and advantages of the present disclosure will become apparent through the following detailed description, or be learned in part through the practice of the present disclosure.

[0009] The embodiments of the present disclosure propose a tracheal dilation device, including: a main body, having a C-shaped structure, and the main body is provided with holes; a pulling wire, one end of which passes through and is fixed in the holes; wherein, the main body is configured to be disposed around the outer circumference of the trachea, and the other end of the pulling wire is fixed to the tracheal adventitia of the trachea, and the main body applies an outward expansion traction force to the tracheal adventitia through the pulling wire.

[0010] According to one embodiment of the present disclosure, the material of the main body is an absorbable material.

[0011] According to one embodiment of the present disclosure, the number of the holes is an even number.

[0012] According to one embodiment of the present disclosure, the main body is provided with a plurality of the holes.

[0013] According to one embodiment of the present disclosure, a plurality of the holes are uniformly distributed on the main body.

[0014] According to one embodiment of the present disclosure, the distance between adjacent two holes is 3 mm to 8 mm.

[0015] According to one embodiment of the present disclosure, the shape of the holes is circular.

[0016] According to one embodiment of the present disclosure, the main body is provided with a plurality of the holes, and the apertures of a plurality of the holes are all equal.

[0017] According to one embodiment of the present disclosure, the aperture of the holes is 1 mm to 3 mm.

[0018] According to one embodiment of the present disclosure, the thickness of the main body in the radial direction is 1 mm to 3 mm.

[0019] According to one embodiment of the present disclosure, at least one side edge on both sides in the radial direction of the body has a chamfer structure.

[0020] An embodiment of the present disclosure provides a method for preparing a tracheal dilation device, including: providing a tracheal dilation device, the tracheal dilation device including a body in a C-shaped structure, the body having a hole; a pulling wire, one end of which passes through and is fixed in the hole; wherein, the body is configured to surround the outer periphery of the trachea, the other end of the pulling wire is fixed to the adventitia of the trachea, and the body applies an outward expansion traction force to the adventitia of the trachea via the pulling wire; obtaining preparation parameters according to the physiological structure of the trachea; performing a bending operation on the body according to the preparation parameters.

[0021] According to one embodiment of the present disclosure, performing a bending operation on the body according to the preparation parameters includes: preheating the body using a preheated electrothermal bender; based on the preparation parameters, performing a bending operation on the preheated body using the electrothermal bender.

[0022] In the tracheal dilation device and its preparation method provided by some embodiments of the present disclosure, the body is fixed to the outer periphery of the trachea and surrounds the trachea via the pulling wire, and one end of the pulling wire passes through and is fixed in the hole, and the other end is fixed to the adventitia of the trachea, so that the body can apply an outward expansion traction force to the adventitia of the trachea via the pulling wire, realizing the outward expansion and fixation of the trachea. Since the other end of the pulling wire is fixed to the adventitia of the trachea, the inner diameter of the trachea can be increased without damaging the inner membrane of the trachea, realizing the expansion of the trachea.

[0023] In the tracheal dilation device provided by some other embodiments of the present disclosure, since the number of holes is an even number, when one end of the pulling wire is fixed to the adventitia of the trachea and the other end passes through and is fixed in the hole, it can ensure that the outward expansion traction force applied by the body to the adventitia of the trachea via the pulling wire is symmetric, realizing uniform traction of the adventitia of the trachea and effective dilation of the tracheal stenosis, effectively treating the tracheal stenosis and avoiding the occurrence of serious restenosis.

[0024] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the present disclosure. Brief Description of the Drawings

[0025] The accompanying drawings herein are incorporated into the specification and constitute a part of this specification, showing embodiments consistent with the present disclosure, and are used together with the specification to explain the principles of the present disclosure. Obviously, the accompanying drawings in the following description are only some embodiments of the present disclosure, and those of ordinary skill in the art can obtain other drawings based on these drawings without creative efforts.

[0026] In the accompanying drawings:

[0027] Figure 1 is a schematic diagram of a tracheal dilator shown according to an exemplary embodiment of the present disclosure;

[0028] Figures 2 - 3 is a schematic structural diagram of the deployed state of a tracheal dilator shown according to another exemplary embodiment of the present disclosure;

[0029] Figure 4 is a schematic diagram of the use of a tracheal dilator shown according to an exemplary embodiment of the present disclosure;

[0030] Figure 5 shows a schematic diagram of an operation of bending the body shown according to an exemplary embodiment of the present disclosure. Detailed Description of the Invention

[0031] Example embodiments will now be described more fully with reference to the accompanying drawings. However, the example embodiments can be implemented in various forms and should not be construed as limited to the examples set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of example embodiments to those skilled in the art.

[0032] In addition, the described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided to give a thorough understanding of the embodiments of the present disclosure. However, those skilled in the art will recognize that the technical solutions of the present disclosure may be practiced without one or more of the specific details, or may be implemented using other methods, components, devices, steps, etc. In other instances, well-known methods, devices, implementations, or operations are not shown or described in detail to avoid obscuring aspects of the present disclosure.

[0033] The block diagrams shown in the accompanying drawings are merely functional entities and do not necessarily correspond to physically independent entities. That is, these functional entities may be implemented in software form, or in one or more hardware modules or integrated circuits, or in different networks and / or processor devices and / or microcontroller devices.

[0034] The flowcharts shown in the accompanying drawings are merely illustrative and do not necessarily include all of the content and operations / steps, nor do they necessarily have to be executed in the order described. For example, some operations / steps may be decomposed, while some operations / steps may be combined or partially combined, so the actual execution order may change according to the actual situation.

[0035] Figure 1 is a schematic diagram of a tracheal dilator shown according to an exemplary embodiment of the present disclosure.

[0036] As Figure 1 shown, a tracheal dilatation device 1 provided by an embodiment of the present disclosure may include: a body 10 having a C-shaped structure, with a hole 11 formed in the body 10; a pulling wire 14, one end of which passes through and is fixed in the hole 10; wherein, the body 10 is configured to surround the outer periphery of the trachea, and the other end of the pulling wire 14 is fixed to the outer membrane body of the trachea, and the body 10 applies an outward expansion traction force to the outer membrane of the trachea via the pulling wire 14.

[0037] In an embodiment of the present disclosure, the body 10 can be fixed to the outer membrane of the tracheal stenosis part via the pulling wire 14 and surround the trachea. One end of the pulling wire 14 passes through and is fixed in the hole 11, and the other end is fixed to the outer membrane of the trachea. It can apply a relatively outward traction force to the trachea through the body 10 via the pulling wire to achieve outward traction on the tracheal stenosis, and then can expand and fix the tracheal stenosis part, completing effective plastic shaping and correction of the tracheal stenosis part. Compared with using a tracheal stent to treat tracheal stenosis, in the tracheal dilatation device 1 of the embodiment of the present disclosure, the other end of the pulling wire 14 is fixed to the outer membrane of the trachea. Therefore, it can increase the tracheal inner diameter without damaging the tracheal intima, playing a role in treating tracheal stenosis, and there will be no serious complications such as tracheal granulation hyperplasia, obstruction, restenosis, etc.; the tracheal dilatation device 1 is convenient to operate when treating tracheal stenosis and can solve the tracheal stenosis that cannot be restored after correction of cardiac malformations at the same time.

[0038] In some embodiments of the present disclosure, the material of the body 10 can be an absorbable material. Among them, the absorbable material can include but is not limited to poly-L-lactic acid (PLLA), polycaprolactone (PCL), etc. Poly-L-lactic acid is an important biodegradable and absorbable polymer material. Its characteristics are non-toxic, non-irritating, biodegradable and absorbable, high strength (flexural strength 190 MPa), good plasticity, good tissue compatibility, and easy to process and form. The degradation period is 2 to 12 months, and it decomposes into water and carbon dioxide. PCL has good biocompatibility, good compatibility with organic polymers, and good biodegradability. It can be used as a cell growth support material, can be compatible with a variety of conventional plastics, and can be completely degraded in the natural environment in 6 - 12 months. In addition, PCL also has good shape memory temperature control properties. In this embodiment, the body 10 made of an absorbable material can realize automatic degradation and absorption after tracheal expansion treatment, and there will be no problems such as hyperplastic granulation tissue, displacement, and affecting ciliary movement. Preferably, in this embodiment, the body made of poly-L-lactic acid material has good compatibility, high strength, and gradually degrades and absorbs on time, completely avoiding serious complications such as tracheal granulation hyperplasia, obstruction, restenosis, etc. brought by stent devices of other materials.

[0039] In some embodiments of the present disclosure, the number of holes 11 may be an even number. For example, the number of holes 11 may be 4, 6, 8, etc. Each hole 11 can be penetrated and fixed by one or more draw wires, and the present disclosure does not make any special limitations thereon.

[0040] In this embodiment, when the number of holes 11 is an even number, when one end of the draw wire 14 is penetrated and fixed on the hole and the other end is fixed on the outer membrane of the trachea, it can ensure that the traction force applied by the body 10 to the outer membrane of the trachea through the draw wire 14 is symmetric, realizing uniform traction of the outer membrane of the trachea and effective dilation of the tracheal stenosis, effectively treating tracheal stenosis and avoiding the occurrence of serious restenosis.

[0041] In some embodiments of the present disclosure, the body 10 is provided with a plurality of holes 11.

[0042] In some embodiments of the present disclosure, the plurality of holes 11 are evenly distributed on the body 10. For example, the plurality of holes 11 may be arranged at intervals on the body 10, and the intervals of the plurality of holes 11 are uniform. For another example, the plurality of holes 11 are arranged in an array and evenly distributed.

[0043] In some embodiments of the present disclosure, the distance between two adjacent holes 11 is 3 mm to 8 mm. Preferably, the distance between two adjacent holes 11 is 6 mm.

[0044] In some embodiments of the present disclosure, the shape of the hole 11 is circular.

[0045] In some embodiments of the present disclosure, the body 10 is provided with a plurality of holes 11, and the apertures of the plurality of holes 11 are all equal.

[0046] In some embodiments of the present disclosure, the aperture of the hole 11 is 1 mm to 3 mm. Preferably, the aperture of the hole 11 is 2.3 mm. The hole with an aperture of 1 mm to 3 mm is easy to pass through the draw wire and can ensure that the size of the body 10 is not too large, is easy to be placed on the outer periphery of the trachea, and will not affect other organs or tissues.

[0047] In some embodiments of the present disclosure, the thickness of the body 10 in the radial direction is 1 mm to 3 mm. Preferably, the thickness of the body 10 in the radial direction is 1.5 mm. The radial direction herein refers to the radial direction after the body 10 is wound around the outer periphery of the trachea, that is, approximately the radial direction of the trachea.

[0048] In some embodiments of the present disclosure, at least one side edge of both sides in the radial direction of the body 10 has a chamfer structure. For example, in some embodiments, the edge of the first side 12 in the radial direction of the body 10 has a chamfer structure. In other embodiments, the edge of the second side 13 in the radial direction of the body 10 has a chamfer structure. In other embodiments, the edges of the first side 12 and the second side 13 of the body 10 have chamfer structures. In this embodiment, the chamfer structure can prevent the edge of the body 10 from wearing the outer membrane of the trachea or other tissues, and better protect the surrounding organ tissues.

[0049] The tracheal dilation device provided by the embodiment of the present disclosure can be fixed to the outer periphery of the trachea via the traction wire by the body and surround the trachea, and one end of the traction wire passes through and is fixed to the hole, and the other end is fixed to the outer membrane of the trachea. The body can apply an outward expansion traction force to the outer membrane of the trachea via the traction wire, so as to realize the outward expansion and fixation of the trachea. Since the other end of the traction wire is fixed to the outer membrane of the trachea, the inner diameter of the trachea can be increased without damaging the inner membrane of the trachea, realizing the expansion of the trachea.

[0050] Figures 2 - 3 It is a schematic structural diagram of the deployed state of the tracheal dilation device shown according to another exemplary embodiment of the present disclosure.

[0051] As Figures 2 - 3 shown, a tracheal dilation device 2 provided by an embodiment of the present disclosure may include: a body 20, having a C-shaped structure, and the body 20 is provided with a hole 21; a traction wire 24, one end of which passes through and is fixed to the hole 20; wherein, the body 20 is configured to surround the outer periphery of the trachea, and the other end of the traction wire 24 is fixed to the outer membrane of the trachea, and the body 20 applies an outward expansion traction force to the outer membrane of the trachea via the traction wire 24.

[0052] In this embodiment, different from the previous embodiment, the number of holes 21 provided in the body 20 is 4. The 4 holes 21 are evenly distributed on the body 20, and the distance h between two adjacent holes 21 may be 6 mm. The shape of the hole 21 is circular. The diameters of the 4 holes 21 are equal, and the diameter r of the 4 holes 21 may be 2.3 mm. The thickness d of the body 20 in the radial direction may be 1.5 mm. The width w of the body 20 may be 5 mm. However, the specific parameters here are only examples, and the technical solution of the present disclosure does not make special limitations on this.

[0053] The first side 22 of the body 20 in the radial direction has a chamfer structure.

[0054] In this embodiment, the edge of the hole 21 has a chamfer structure.

[0055] In this embodiment, the chamfered structure in the radial direction of the body 20 can prevent the edge of the body 20 from causing wear or damage to the tracheal adventitia or other tissues, so as to better protect the organ tissues. The chamfered structure at the edge of the hole 21 can reduce the wear of the pull wire when it passes through the hole 21, and improve the stability of the tracheal dilation device when it is fixed to the periphery of the trachea.

[0056] Figure 4 It is a schematic diagram showing the use of a tracheal dilation device according to an exemplary embodiment of the present disclosure.

[0057] like Figure 4 As shown, the tracheal dilation device 3 includes a body 30, which is a C-shaped structure. The body 30 is provided with four holes 311-314; one end of the pulling wires 51, 52, 53, 54 is passed through and fixed to the holes 311-314 respectively; wherein the body 30 is configured to surround the outer periphery of the trachea, and the other end of the pulling wires 51-54 is fixed to the tracheal adventitia of the trachea, and the body 30 applies a traction force to expand the tracheal adventitia 41 outward through the pulling wires 51, 52, 53, 54. Among them, one end of the pulling wires 51-54 is the end in contact with the body 30, and the other end is the end in contact with the tracheal adventitia 41. For example, one end of the pulling wire 51 is passed through and fixed in the hole 311, and the other end is fixed to the tracheal adventitia 4 of the trachea; one end of the pulling wire 52 is passed through and fixed in the hole 312, and the other end is fixed to the tracheal adventitia 41 of the trachea; one end of the pulling wire 53 is passed through and fixed in the hole 313, and the other end is fixed to the tracheal adventitia 41 of the trachea; one end of the pulling wire 54 is passed through and fixed in the hole 314, and the other end is fixed to the tracheal adventitia 41 of the trachea.

[0058] In this embodiment, the tracheal adventitia 41 is symmetrically pulled by the pulling wires 51, 52, 53, 54, so that when the pulling wires 51, 52, 53, 54 pass through the tracheal adventitia 41 and the four holes 311 to 314, the pulling force of the pulling wires 51, 52, 53, 54 is symmetrical relative to the center of the tracheal cross-section, thereby ensuring uniform pulling of the tracheal adventitia 41, achieving symmetrical, uniform and effective expansion of the tracheal stenosis, effectively treating tracheal stenosis, and avoiding the serious situation of restenosis.

[0059] In this embodiment, one end of the pulling wires 51, 52, 53, 54 passes through and is fixed to the hole 31 opened on the main body 30, and the other end is fixed to the tracheal adventitia 41 of the trachea 40, so that the traction point for outward expansion of the stenosis of the tracheal adventitia can be determined. The pulling wires 51, 52, 53, 54 pass through the tracheal adventitia and pull the tracheal adventitia, so that the tracheal adventitia 41 can be stretched toward the traction point, thereby achieving precise expansion of the tracheal adventitia 41, increasing the inner diameter of the trachea without damaging the tracheal endothelium, and can be used to treat primary tracheal stenosis combined with congenital heart disease to relieve tracheal stenosis.

[0060] In some embodiments of this embodiment, the tracheal dilator 3 can be coated with autologous pericardium or Gore-Tex membrane to avoid abrasion to adjacent tissues and organs. Among them, autologous pericardium is the membranous sac covering the surface of the heart. The pericardium is the pericardial membrane. It is an approximately conical fibroserous sac that wraps around the heart and the roots of the large blood vessels entering and leaving the heart. It can be divided into fibrous pericardium and serous pericardium. Gore-Tex membrane is a waterproof and breathable functional material widely used in cardiac and great vessel surgery.

[0061] The embodiments of the present disclosure also provide a preparation method of a tracheal dilator, and the preparation method of the tracheal dilator at least includes the following steps.

[0062] In this embodiment, a tracheal dilator is provided. The tracheal dilator includes a body having a C-shaped structure and having holes; a pulling wire, one end of which passes through and is fixed in the hole; wherein, the body is configured to surround the outer periphery of the trachea, and the other end of the pulling wire is fixed to the adventitia of the trachea, and the body applies an outward expansion traction force to the adventitia of the trachea through the pulling wire. Among them, the tracheal dilator can be, for example Figures 1 to 4 the tracheal dilator shown in any embodiment.

[0063] Preparation parameters are obtained according to the physiological structure of the trachea. In some embodiments of this embodiment, the preparation parameters may include the inner diameter of the body, etc. The inner diameter of the body can be determined according to the physiological structure of the trachea, such as the normal outer diameter of the trachea. The preparation parameters can be determined according to actual operation experience. For example, for patients of different ages, determine the diameter of the normal part of their trachea, the degree of stenosis of the stenotic part of the trachea, etc. Among them, the airway can be evaluated by fiberoptic bronchoscopy for accurate positioning, cleaning of the respiratory tract, and evaluation of the degree of tracheal stenosis.

[0064] When determining the preparation parameters, for example, patients can be divided according to age, and the diameter parameters based on the physiological structure of the trachea under each age division can be obtained. And the inner diameter (preparation parameter) under different age divisions can be determined according to the diameter of the normal part of the trachea under different age divisions. Also, for example, when determining the preparation parameters, patients can be divided according to the degree of tracheal stenosis, and the empirical data of the number of multiple holes under different degrees of stenosis can be obtained, and the number of multiple holes (preparation parameter) under different age divisions can be determined according to the empirical data of the number of multiple holes under different degrees of stenosis divisions.

[0065] In some embodiments of this embodiment, for patients with primary tracheal stenosis or tracheomalacia complicated with congenital heart disease, a fiberoptic bronchoscope can also be used during the operation to evaluate the airway before cardiac surgery, after correction of intracardiac malformations, and after stopping the cardiopulmonary bypass machine: accurately locate, clean the respiratory tract, evaluate the degree of tracheal stenosis, and determine the preparation parameters according to the degree of stenosis. The fiberoptic bronchoscope can also prevent deep suture damage to the intima and evaluate the treatment effect.

[0066] After determining the preparation parameters, perform a bending operation on the body according to the preparation parameters.

[0067] In some embodiments of this embodiment, an electric heating bender can be used to perform a bending operation on the body.

[0068] In some embodiments of this embodiment, the tracheal dilator can be coated with autologous pericardium or Gore-Tex membrane to avoid abrasion of adjacent tissues and organs.

[0069] The preparation method of the tracheal dilator provided by the embodiments of the present disclosure can obtain tracheal dilators suitable for different types of patients according to different specifications of preparation parameters. It is convenient to operate. In the obtained tracheal dilator, the body is fixed to the outer periphery of the trachea via the traction wire and surrounds the trachea, and one end of the traction wire is fixed to the adventitia of the trachea, and the other end passes through and is fixed to the hole. The body can apply a relatively outward traction force to the tracheal adventitia via the traction wire to achieve outward expansion and fixation of the trachea. Since the other end of the traction wire is fixed to the tracheal adventitia, the inner diameter of the trachea can be increased without damaging the tracheal intima, realizing tracheal expansion. This tracheal dilator can be applied to the simultaneous tracheal correction of primary tracheal stenosis complicated with congenital heart disease, solve the tracheal stenosis that cannot be restored after correction of cardiac malformations, and reduce the mortality rate of children with primary tracheal stenosis complicated with congenital heart disease.

[0070] In some embodiments of the embodiments of the present disclosure, when performing a bending operation on the body according to the preparation parameters, the following steps can also be performed.

[0071] Preheat the body using a preheated electric heating bender.

[0072] In the embodiments of the present disclosure, when the material of the body is poly-L-lactic acid, the working temperature of the electric heating bender can be determined to be 95°C to 105°C and preheated for 2 - 3 minutes. Among them, the tracheal dilator can be preheated using the preheated electric heating bender for 6 - 8 seconds.

[0073] After the preheating of the body is completed, perform a bending operation on the preheated body using the electric heating bender based on the preparation parameters.

[0074] In the embodiments of the present disclosure, an acute-angled transverse bending operation can be performed on the preheated tracheal dilator using the electric heating bender.Figure 5 The schematic diagram of the operation of bending the body shown according to an exemplary embodiment of the present disclosure. Among them, Figure 5 In the body 50 shown in the embodiment, the connection part of adjacent holes 51 may have a recessed part.

[0075] In some embodiments of this embodiment, bilateral symmetrical sutures of bronchial cartilage can be performed under a fiberoptic bronchoscope to accurately fix the tracheal dilation device to the tracheal stenosis site.

[0076] The preparation method of the tracheal dilation device provided by the embodiments of the present disclosure has the advantages of convenient operation and can complete tracheal correction synchronously. Moreover, the tracheal dilation device prepared by the embodiments of the present disclosure has good material tissue compatibility, high strength, and gradually degrades and absorbs on time, completely avoiding the defects of tracheal granulation hyperplasia and obstruction brought by the existing tracheal stent method, as well as serious complications such as restenosis that may occur in tracheal bypass surgery. The tracheal shaping and correction effect of this tracheal dilation device is satisfactory, improving the prognosis of children.

[0077] Those skilled in the art can understand that all or part of the steps of implementing the above embodiments are implemented as a computer program executed by a central processing unit (CPU). When this computer program is executed by the central processing unit CPU, the above functions defined by the above system provided by the present disclosure are executed. The said program can be stored in a computer-readable storage medium, and this storage medium can be a read-only memory, a disk or an optical disc, etc.

[0078] In addition, it should be noted that the above drawings are only schematic illustrations of the processes included in the system according to the exemplary embodiments of the present disclosure, rather than for limiting purposes. It is easy to understand that the processes shown in the above drawings do not indicate or limit the time sequence of these processes. Additionally, it is also easy to understand that these processes can be executed synchronously or asynchronously in, for example, multiple modules.

[0079] Those skilled in the art can understand that the above-mentioned modules can be distributed in the method according to the description of the embodiment, or can be correspondingly changed and uniquely different in one or more methods different from this embodiment. The modules of the above embodiment can be combined into one module, or can be further split into multiple sub-modules.

[0080] Through the description of the above embodiments, those skilled in the art can easily understand that the exemplary embodiments described herein can be implemented by software or by a combination of software and necessary hardware. Therefore, the technical solution according to the embodiments of the present disclosure can be embodied in the form of a software product, which can be stored in a non-volatile storage medium (which can be a CD-ROM, a USB flash drive, a mobile hard disk, etc.) or on a network, including several instructions to enable a computing device (which can be a personal computer, a server, a mobile terminal, or a network device, etc.) to execute the system according to the embodiments of the present disclosure.

[0081] The above specifically shows and describes the exemplary embodiments of the present disclosure. It should be understood that the present disclosure is not limited to the detailed structure, setting method, or implementation system described herein; on the contrary, the present disclosure is intended to cover various modifications and equivalent settings included within the spirit and scope of the appended claims.

Claims

1. A tracheal dilator device, characterized in that, it includes: a body, having a C-shaped structure, and the body is provided with holes; a pulling wire, one end of which passes through and is fixed in the hole; wherein, the body is configured to surround the outer periphery of the trachea, the other end of the pulling wire is fixed to the adventitia of the trachea, and the body applies an outward expansion traction force to the adventitia of the trachea through the pulling wire, the body is provided with a plurality of the holes, and the plurality of holes are arranged at intervals on the body, or, the plurality of holes are arranged in an array.

2. The tracheal dilator device according to claim 1, characterized in that, the material of the body is an absorbable material.

3. The tracheal dilator device according to claim 1, characterized in that, the shape of the hole is circular.

4. The tracheal dilator device according to claim 3, characterized in that, the body is provided with a plurality of the holes, and the apertures of the plurality of holes are all equal.

5. The tracheal dilator device according to claim 3, characterized in that, the aperture of the hole is 1 mm to 3 mm.

6. The tracheal dilator device according to claim 1, characterized in that, the thickness of the body in the radial direction is 1 mm to 3 mm.

7. The tracheal dilator device according to claim 1, characterized in that, at least one side of the two sides of the body in the radial direction has a chamfer structure.

8. A method for preparing a tracheal dilator device, characterized in that, it includes: providing a tracheal dilator device, the tracheal dilator device includes a body, having a C-shaped structure, and the body is provided with holes; a pulling wire, one end of which passes through and is fixed in the hole; wherein, the body is configured to surround the outer periphery of the trachea, the other end of the pulling wire is fixed to the adventitia of the trachea, and the body applies an outward expansion traction force to the adventitia of the trachea through the pulling wire; obtaining preparation parameters according to the physiological structure of the trachea; performing a bending operation on the body according to the preparation parameters.

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