阅读说明：本技术 气管扩张装置及其制备方法 (Tracheal expansion device and preparation method thereof ) 是由 李守军 芮璐 张森 于 2020-03-23 设计创作，主要内容包括：本公开的实施例提供了一种气管扩张装置及其制备方法。该装置包括：本体,呈C型结构,所述本体开设有孔；牵拉丝,一端穿设并固定于所述孔；其中,所述本体被配置为环绕设于气管的外周,所述牵拉丝的另一端固定于所述气管的气管外膜,所述本体经由所述牵拉丝对所述气管外膜施加向外扩张的牵引力。本公开实施例提供的气管扩张装置及其制备方法通过本体经由牵拉丝固定于气管外周并环绕该气管,并通过牵拉丝一端固定于该气管的气管外膜,另一端穿设并固定于所述孔,能够由本体经由牵拉丝对气管施加向外扩张的牵引力,实现气管向外的扩张和固定,由于牵拉丝一端固定于气管外膜,能够在不损伤气管内膜的情况下增加气管内径,实现气管扩充。(Embodiments of the present disclosure provide a tracheal expansion device and a method of making the same. The device includes: the body is of a C-shaped structure, and is provided with a hole; a drawing wire, one end of which is arranged through and fixed in the hole; wherein the body is configured to be arranged around the periphery of an air tube, the other end of the traction wire is fixed on the outer tracheal film of the air tube, and the body applies outward expansion traction force to the outer tracheal film through the traction wire. The trachea expansion device and the preparation method thereof provided by the embodiment of the disclosure are characterized in that the body is fixed on the periphery of the trachea through the traction wire and surrounds the trachea, one end of the traction wire is fixed on the outer trachea membrane of the trachea, the other end of the traction wire penetrates through and is fixed in the hole, the traction force for outward expansion can be applied to the trachea through the traction wire by the body, the outward expansion and fixation of the trachea are realized, and the inner diameter of the trachea can be increased under the condition of not damaging the inner trachea membrane due to the fact that one end of the traction wire is fixed on the outer trachea membrane, and the trachea expansion is realized.)

1. A tracheal dilation device, comprising:

the body is of a C-shaped structure, and is provided with a hole;

a drawing wire, one end of which is arranged through and fixed in the hole;

wherein the body is configured to be arranged around the periphery of an air tube, the other end of the traction wire is fixed on the outer tracheal film of the air tube, and the body applies outward expansion traction force to the outer tracheal film through the traction wire.

2. The tracheal dilation device of claim 1, wherein the body is made of an absorbable material.

3. The tracheal dilation device of claim 1, wherein the body defines a plurality of the holes.

4. The tracheal dilating device of claim 3, wherein the plurality of holes are uniformly distributed on the body, and a distance between two adjacent holes is 3mm to 8 mm.

5. The tracheal dilation device of claim 1, wherein the aperture is circular in shape.

6. The tracheal dilation device of claim 5, wherein the body defines a plurality of the holes, the plurality of holes having an equal diameter.

7. The tracheal dilation device of claim 5, wherein the aperture of the holes is between 1mm and 3 mm.

8. The tracheal dilation device of claim 1, wherein the body has a thickness in the radial direction of 1mm to 3 mm.

9. The tracheal dilating device of claim 1, wherein an edge of at least one of two sides of the body in a radial direction has a chamfered structure.

10. A method of making a tracheal expansion device comprising:

the trachea expanding device comprises a body, wherein the body is of a C-shaped structure, and a hole is formed in the body; a drawing wire, one end of which is arranged through and fixed in the hole; wherein the body is configured to be arranged around the periphery of a trachea, the other end of the traction wire is fixed on the outer tracheal film of the trachea, and the body applies outward expansion traction force to the outer tracheal film through the traction wire;

obtaining preparation parameters according to the physiological structure of the trachea;

and bending the body according to the preparation parameters.

Technical Field

The disclosure relates to the field of medical instruments, in particular to a tracheal dilation device and a preparation method thereof.

Background

Congenital Heart Disease (CHD) is one of the most common Congenital malformations in children, and the worldwide statistical incidence rate is 5-8 per thousand. With the continuous progress of prenatal diagnosis, intensive care level and pediatric cardiac surgery, the incidence of complications and mortality associated with CHD is well controlled and CHD is no longer considered a fatal disease. However, when CHD patients suffer from complicated primary tracheal Stenosis (CTS) or Tracheal Malacia (TM), the mortality and complication rates of CHD treatment are significantly increased, severely affecting the quality of the new-born population and increasing the national medical burden. The treatment of CTS and TM combined congenital heart disease is always a clinical difficulty, and the current treatment modes include: tracheal stenting and open tracheal placement.

Among them, the tracheal stenting generally supports and expands the tracheal intima through a metal stent, a plastic stent or a silica gel stent. Although the grid structure of the metal stent has the advantages of no influence on the movement of the tracheal cilia, large diameter, thin tube wall, difficult displacement and the like, granulation tissues are very easy to form to block the airway, and the metal stent is easy to invade the bronchial wall and difficult to take out, and is easy to break to cause tracheal fistula. The tracheal stent made of plastic and silica gel is most widely applied, has better tissue compatibility, is not easy to grow granulation tissues, but has limited selectable stent types (large stents are often needed), is easy to deform and shift, influences cilia movement and is easy to block. At present, the tracheal granulation tissue hyperplasia is less after the composite material is applied, the influence of ciliary movement is small, but the requirements of the stent on the apparatus are high, and the stent cannot be applied to small infants temporarily; while degradable stents tend to curl, have limited stenting time (about 6-7 weeks), and tend to block airways after degradation.

The trachea stenosis can not be thoroughly improved by the trachea open operation, and the repeated lung infection, hypoxemia and the condition of being unable to be separated from a breathing machine are very likely to occur after the operation. For children patients with trachea compression or severe trachea softening, conservative treatment is carried out on the open position of the qi-moving tube, postoperative related complications and the using time of a breathing machine are obviously prolonged, and the death rate is obviously increased.

Therefore, the trachea dilator and the preparation method thereof can accurately dilate and fix the outer trachea membrane, increase the inner diameter of the trachea under the condition of not damaging the inner trachea membrane, can be applied to the treatment of primary trachea stenosis with congenital heart disease, and can relieve the trachea stenosis.

It is to be noted that the information disclosed in the above background section is only for enhancement of understanding of the background of the present disclosure, and thus may include information that does not constitute prior art known to those of ordinary skill in the art.

Disclosure of Invention

The embodiment of the disclosure provides a tracheal expansion device and a preparation method thereof, so that the tracheal adventitia is accurately expanded and fixed at least to a certain extent, the inner diameter of a trachea is increased under the condition of not damaging the tracheal intima, and the tracheal expansion device can be applied to treatment of primary tracheal stenosis and tracheal softening of congenital heart disease and can be used for relieving the tracheal stenosis.

Additional features and advantages of the disclosure will be set forth in the detailed description which follows, or in part will be obvious from the description, or may be learned by practice of the disclosure.

The disclosed embodiment provides a trachea expanding device, which comprises: the body is of a C-shaped structure, and is provided with a hole; a drawing wire, one end of which is arranged through and fixed in the hole; wherein the body is configured to be arranged around the periphery of an air tube, the other end of the traction wire is fixed on the outer tracheal film of the air tube, and the body applies outward expansion traction force to the outer tracheal film through the traction wire.

According to one embodiment of the present disclosure, the material of the body is an absorbable material.

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

According to one embodiment of the present disclosure, the body defines a plurality of the holes.

According to one embodiment of the present disclosure, the plurality of holes are evenly distributed on the body.

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

According to one embodiment of the present disclosure, the hole is circular in shape.

According to one embodiment of the present disclosure, the body is provided with a plurality of holes, and the holes have the same diameter.

According to one embodiment of the present disclosure, the hole has a hole diameter of 1mm to 3 mm.

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

According to one embodiment of the present disclosure, an edge of at least one of two sides of the body in a radial direction has a chamfered structure.

The embodiment of the disclosure provides a preparation method of a tracheal expansion device, which comprises the following steps: the trachea expanding device comprises a body, wherein the body is of a C-shaped structure, and a hole is formed in the body; a drawing wire, one end of which is arranged through and fixed in the hole; wherein the body is configured to be arranged around the periphery of a trachea, the other end of the traction wire is fixed on the outer tracheal film of the trachea, and the body applies outward expansion traction force to the outer tracheal film through the traction wire; obtaining preparation parameters according to the physiological structure of the trachea; and bending the body according to the preparation parameters.

According to one embodiment of the present disclosure, the bending operation of the body according to the preparation parameters includes: preheating the body by utilizing a preheated electrothermal bender; and based on the preparation parameters, bending the preheated body by using the electric heating bender.

According to the tracheal expansion device and the preparation method thereof provided by some embodiments of the disclosure, the body is fixed on the periphery of the trachea through the traction wire and surrounds the trachea, one end of the traction wire penetrates through and is fixed in the hole, the other end of the traction wire is fixed on the outer tracheal membrane of the trachea, the body can apply traction force for outward expansion to the outer tracheal membrane through the traction wire, so that outward expansion and fixation of the trachea are realized, and the inner diameter of the trachea can be increased under the condition that the inner tracheal membrane is not damaged due to the fact that the other end of the traction wire is fixed on the outer tracheal membrane, so that tracheal expansion is realized.

In the tracheal dilation device provided by another embodiment of the disclosure, since the number of the holes is even, when one end of the traction wire is fixed to the tracheal adventitia of the trachea and the other end of the traction wire penetrates through and is fixed to the hole, it can be ensured that the traction force of the body applying outward dilation to the tracheal adventitia through the traction wire is symmetrical, uniform traction to the tracheal adventitia and effective dilation to the tracheal stenosis are realized, the tracheal stenosis is effectively treated, and the occurrence of severe cases of restenosis is avoided.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present disclosure and together with the description, serve to explain the principles of the disclosure. It is to be understood that the drawings in the following description are merely exemplary of the disclosure, and that other drawings may be derived from those drawings by one of ordinary skill in the art without the exercise of inventive faculty.

In the drawings:

fig. 1 is a schematic view of a tracheal expansion device shown in accordance with an exemplary embodiment of the present disclosure;

FIGS. 2-3 are structural schematic views illustrating a deployed state of a tracheal expansion device, according to another exemplary embodiment of the present disclosure;

FIG. 4 is a schematic view of a use of a tracheal expansion device, shown in accordance with an exemplary embodiment of the present disclosure;

fig. 5 illustrates an operational diagram of bending a body according to an exemplary embodiment of the present disclosure.

Detailed Description

Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments may, however, be embodied in many different 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.

Furthermore, 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 embodiments of the disclosure. One skilled in the relevant art will recognize, however, that the subject matter of the present disclosure can be practiced without one or more of the specific details, or with other methods, components, devices, steps, and so forth. In other instances, well-known methods, devices, implementations, or operations have not been shown or described in detail to avoid obscuring aspects of the disclosure.

The block diagrams shown in the figures are functional entities only and do not necessarily correspond to physically separate entities. I.e. these functional entities may be implemented in the form of software, or in one or more hardware modules or integrated circuits, or in different networks and/or processor means and/or microcontroller means.

The flow charts shown in the drawings are merely illustrative and do not necessarily include all of the contents and operations/steps, nor do they necessarily have to be performed in the order described. For example, some operations/steps may be decomposed, and some operations/steps may be combined or partially combined, so that the actual execution sequence may be changed according to the actual situation.

Fig. 1 is a schematic view of a tracheal expansion device shown in accordance with an exemplary embodiment of the present disclosure.

As shown in fig. 1, a tracheal dilating device 1 provided by the embodiment of the present disclosure may include: the body 10 is of a C-shaped structure, and the body 10 is provided with a hole 11; a drawing wire 14 with one end passing through and fixed in the hole 10; wherein the body 10 is configured to surround the periphery of the trachea, and the outer tracheal film body 10 with the other end of the pulling wire 14 fixed to the trachea applies an outward expanding traction force to the outer tracheal film through the pulling wire 14.

In this disclosed embodiment, body 10 can be fixed in on the trachea adventitia of trachea stenosis portion and encircle this trachea via tractive line 14, and hole 11 is worn to establish and is fixed in by the one end of tractive line 14, and the other end is fixed in tracheal trachea adventitia, can be right through body 10 via the tractive line the trachea is applyed relative outside traction force and is realized the outside tractive to trachea stenosis department, and then can expand fixedly to trachea stenosis portion, accomplishes effective plasticity to trachea stenosis portion and corrects. Compared with the treatment of tracheal stenosis by using a tracheal stent, the tracheal stent 1 of the embodiment of the disclosure is fixed on the tracheal adventitia of the trachea by the other end of the traction wire 14, so that the inner diameter of the trachea can be increased under the condition of not damaging the tracheal intima, the effect of treating the tracheal stenosis is achieved, and serious complications such as tracheal granulation hyperplasia, obstruction, restenosis and the like do not occur; the tracheal dilating device 1 is convenient to operate when treating tracheal stenosis, and can simultaneously solve the problem of tracheal stenosis which cannot be recovered after the correction of the cardiac malformation.

In some embodiments of the present disclosure, the material of the body 10 may be an absorbable material. The absorbable material may include, but is not limited to, Poly-L-Lactic-Acid (PLLA), Polycaprolactone (PCL), and the like. The poly-L-lactic acid is an important biodegradable and absorbable high molecular material, and has the characteristics of no toxicity, no irritation, biodegradable absorption, high strength (the flexural strength is 190MPa), good plasticity, good histocompatibility and easy processing and forming. The degradation period is 2-12 months, and the materials are decomposed into water and carbon dioxide. PCL has good biocompatibility, good organic polymer compatibility and good biodegradability, can be used as a cell growth support material, can be compatible with various conventional plastics, and can be completely degraded in natural environment within 6-12 months. . In addition, PCL also has good shape memory temperature control properties. In this embodiment, the body 10 made of absorbable material can realize automatic degradation and absorption after trachea expansion treatment, and the problems of granulation tissue proliferation, displacement, influence on ciliary movement and the like can be avoided. Preferably, in the embodiment, the body made of the poly-L-lactic acid material has good compatibility and high strength, and is degraded and absorbed step by step on time, so that serious complications of tracheal granulation hyperplasia, blockage, restenosis and the like caused by stent devices made of other materials are completely avoided.

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 may be penetrated and fixed by one or more pulling wires, which is not limited in this disclosure.

In this embodiment, when the number of the holes 11 is even, when one end of the pulling wire 14 is inserted into and fixed to the hole, and the other end of the pulling wire is fixed to the tracheal adventitia, it can be ensured that the traction force of the body 10 for applying outward expansion to the tracheal adventitia via the pulling wire 14 is symmetrical, thereby realizing uniform traction to the tracheal adventitia and effective expansion to the tracheal stenosis, effectively treating the tracheal stenosis, and avoiding the occurrence of severe restenosis.

In some embodiments of the present disclosure, the body 10 defines a plurality of apertures 11.

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

In some embodiments of the present disclosure, the distance between two adjacent holes 11 is 3mm to 8mm, and preferably, the distance between two adjacent holes 11 is 6 mm.

In some embodiments of the present disclosure, the shape of the aperture 11 is circular.

In some embodiments of the present disclosure, the body 10 is provided with a plurality of holes 11, and the holes 11 have the same diameter.

In some embodiments of the present disclosure, the aperture of the hole 11 is 1mm to 3mm, and preferably, the aperture of the hole 11 is 2.3 mm. The hole with the aperture of 1 mm-3 mm is easy to pass through the traction wire, and can ensure that the size of the body 10 is not overlarge, and the body is easy to be placed on the periphery of a trachea and cannot influence other organs or tissues.

In some embodiments of the present disclosure, the thickness of the body 10 in the radial direction is 1mm to 3 mm. Preferably, the thickness of the body 10 in the radial direction is 1.5 mm. The radial direction refers to the radial direction of the body 10 around the circumference of the trachea, i.e. the radial direction is similar to the trachea.

In some embodiments of the present disclosure, an edge of at least one of two sides of the body 10 in a radial direction has a chamfered structure. For example, in some embodiments, the edge of the first side 12 in the radial direction of the body 10 has a chamfered structure. In other embodiments, the edge of the second side 13 in the radial direction of the body 10 has a chamfered structure. In other embodiments, the edges of the first side 12 and the edges of the second side 13 of the body 10 have a chamfered configuration. In this embodiment, the chamfer structure can prevent the edge of the body 10 from wearing the adventitia or other tissues, so as to better protect the surrounding organ tissues.

The utility model provides a trachea expanding device is fixed in trachea periphery and encircles this trachea through the body via the wire that leads to wear to establish and be fixed in through wire one end hole, the other end is fixed in this tracheal adventitia, can be by the body via the traction wire exert the traction force of outside expansion to the tracheal adventitia, realizes the outside expansion of trachea and fixes, because the wire that leads to other end is fixed in the tracheal adventitia, can increase the trachea internal diameter under the condition that does not harm the endotracheal intima, realizes the trachea and expands.

Fig. 2 to 3 are structural diagrams illustrating a deployed state of a tracheal expansion device according to another exemplary embodiment of the present disclosure.

As shown in fig. 2 to 3, a tracheal dilating device 2 provided by the embodiment of the present disclosure may include: the body 20 is of a C-shaped structure, and the body 20 is provided with a hole 21; a pulling wire 24 with one end passing through and fixed in the hole 20; wherein the body 20 is configured to surround the outer circumference of the trachea, the other end of the pull wire 24 is fixed to the outer tracheal membrane of the trachea, and the body 20 applies an outward expanding traction force to the outer tracheal membrane via the pull wire 24.

In this embodiment, unlike the previous embodiment, the number of the holes 21 opened in the body 20 is 4. The 4 holes 21 are uniformly distributed on the body 20, and the distance h between two adjacent holes 21 can be 6 mm. The shape of the hole 21 is circular. The aperture of each of the 4 holes 21 is equal, and the aperture r of each 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 body 20 may have a width w of 5 mm. However, the specific parameters are only examples, and the technical solution of the present disclosure is not limited thereto.

The first side 22 in the radial direction of the body 20 has a chamfered structure.

In this embodiment, the edges of the hole 21 have a chamfered configuration.

In this embodiment, the body 20 has a chamfered structure in the radial direction to avoid abrasion or damage of the adventitia or other tissue by the edge of the body 20, so as to protect the organ tissue better. The chamfer structure at the edge of the hole 21 can reduce the abrasion to the drawing wire when the drawing wire penetrates through the hole 21, and improves the stability of the tracheal expansion device when being fixed on the periphery of the trachea.

Fig. 4 is a schematic view illustrating the use of a tracheal expansion device according to an exemplary embodiment of the present disclosure.

As shown in fig. 4, the tracheal dilating device 3 comprises a body 30 which is of a C-shaped structure, wherein the body 30 is provided with 4 holes 311-314; pulling wires 51, 52, 53 and 54, one ends of which are penetrated and fixed in the holes 311-314 respectively; the body 30 is arranged to surround the outer periphery of the trachea, the other ends of the pulling wires 51 to 54 are fixed to the outer tracheal membrane of the trachea, and the body 30 applies a traction force expanding outward to the outer tracheal membrane 41 through the pulling wires 51, 52, 53, and 54. Wherein, one end of the pulling wire 51-54 is the end contacting with the body 30, and the other end is the end contacting with the outer trachea membrane 41. For example, the pull wire 51 has one end inserted and fixed in the hole 311 and the other end fixed to the tracheal outer membrane 4 of the trachea; one end of the traction wire 52 is arranged through and fixed in the hole 312, and the other end is fixed on the outer tracheal film 41 of the trachea; one end of the traction wire 53 is arranged in the hole 313 in a penetrating way and fixed, and the other end is fixed on the outer tracheal film 41 of the trachea; one end of the pulling wire 54 is fixed in the hole 314 through the penetration, and the other end is fixed in the outer tracheal film 41 of the trachea.

In this embodiment, the outer tracheal film 41 is symmetrically drawn by the drawing wires 51, 52, 53 and 54, so that when the drawing wires 51, 52, 53 and 54 pass through the outer tracheal film 41 and the 4 holes 311 to 314, the drawing force of the drawing wires 51, 52, 53 and 54 is ensured to be symmetrical relative to the circle center of the tracheal cross section, and further the uniform drawing of the outer tracheal film 41 can be ensured, the symmetric, uniform and effective expansion of the tracheal stenosis can be realized, the tracheal stenosis can be effectively treated, and the severe restenosis can be avoided.

In this embodiment, the pulling wires 51, 52, 53, 54 have one end inserted through and fixed to the hole 31 formed in the body 30 and the other end fixed to the outer tracheal film 41 of the trachea 40, and can determine a pulling point at which the outer tracheal film stenosis expands outward, and the pulling wires 51, 52, 53, 54 are inserted through and pull the outer tracheal film to stretch the outer tracheal film 41 toward the pulling point, thereby realizing precise expansion of the outer tracheal film 41, increasing the inner tracheal diameter without damaging the inner tracheal film, and being applicable to treatment of primary tracheal stenosis associated with congenital heart disease, and relieving the tracheal stenosis.

In some of these embodiments, the tracheal expansion device 3 may be coated with autologous pericardium or Goretex (Goretex) membrane to avoid abrasion of adjacent tissues and organs. Wherein, the autologous pericardium is a membranous sac covering the surface of the heart. The pericardium is the pericardium. Is a fibrous serosal sac which is approximately conical and is wrapped outside the heart and the root of a great vessel which enters and exits the heart. It can be divided into fibrous pericardium and serous pericardium. The Goerts membrane is a waterproof and breathable functional material and is widely used for cardiac great vessel surgery.

The embodiment of the disclosure also provides a preparation method of the tracheal expansion device, which at least comprises the following steps.

In this embodiment, a tracheal expansion device is provided, which comprises a body in a C-shaped structure, wherein the body is provided with a hole; a drawing wire, one end of which is arranged through and fixed in the hole; the body is arranged around the periphery of the trachea, the other end of the traction wire is fixed on the outer trachea membrane of the trachea, and the body applies outward expansion traction force to the outer trachea membrane through the traction wire. The tracheal expansion device may be, for example, the tracheal expansion device shown in any one of the embodiments of fig. 1-4.

The preparation parameters are obtained according to the physiological structure of the trachea. In some of this embodiment, the preparation parameters may include body inside diameter, and the like. 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, the tube diameter of the normal part of the trachea, the degree of stenosis of the narrow part of the trachea, and the like are determined. Wherein, accessible fiber bronchoscope aassessment air flue, accurate positioning, clearance respiratory tract, aassessment trachea stenosis degree.

In determining the preparation parameters, the patient may be divided, for example, according to age, and the tube diameter parameters based on the physiological structure of the trachea for each age division are obtained. And the inner diameters (preparation parameters) of the bodies under different ages can be determined according to the pipe diameters of the normal parts of the trachea under different ages. For another example, in determining the preparation parameters, the patient may be divided according to the degree of tracheal stenosis, empirical data of the number of the plurality of holes at different degrees of stenosis may be obtained, and the number of the plurality of holes at different ages may be determined (preparation parameters) according to the empirical data of the number of the plurality of holes at different degrees of stenosis.

In some embodiments of this embodiment, for patients with primary tracheal stenosis or tracheal malacia complicated with congenital heart disease, the airway can also be assessed with a fiberbronchoscope before cardiac surgery, after correction of intracardiac deformity, after stopping the extracorporeal circulation machine: accurate positioning, cleaning respiratory tract, evaluating tracheal stenosis degree, and determining preparation parameters according to the stenosis degree. The fiberoptic bronchoscope can also prevent the suture from deeply damaging the intima and evaluate the treatment effect.

After the preparation parameters are determined, a bending operation is performed on the body according to the preparation parameters.

In some of these embodiments, the bending operation may be performed on the body using an electrothermal bender.

In some of these embodiments, the tracheal expansion device may be coated with autologous pericardium or Goerts' membrane to avoid abrasion of adjacent tissues and organs.

According to the preparation method of the tracheal expansion device, the tracheal expansion device suitable for different types of patients can be obtained according to preparation parameters of different specifications, the operation is convenient, in the obtained tracheal expansion device, the body is fixed on the periphery of a trachea through the traction wire and surrounds the trachea, one end of the traction wire is fixed on an outer tracheal membrane of the trachea, the other end of the traction wire penetrates through and is fixed in the hole, the body can apply outward traction force to the outer tracheal membrane through the traction wire, the outward expansion and fixation of the trachea are achieved, and the inner diameter of the trachea can be increased under the condition that the inner tracheal membrane is not damaged due to the fact that the other end of the traction wire is fixed on the outer tracheal membrane, and the trachea expansion is achieved. The trachea dilating device can be applied to contemporaneous trachea correction of primary trachea stenosis combined with congenital heart diseases, tracheal stenosis which cannot be recovered after heart malformation correction is solved contemporaneously, and the death rate of children suffering from primary trachea stenosis combined with congenital heart diseases is reduced.

In some embodiments of the disclosed embodiments, the following steps may also be performed when performing the bending operation on the body according to the preparation parameters.

The body is preheated by a preheated electrothermal bender.

In the embodiment of the 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 ℃ to 105 ℃ and the electric heating bender can be preheated for 2-3 minutes. Wherein, the preheating electrothermal bender can be used for preheating the tracheal expansion device for 6-8 seconds.

After the body is preheated, the preheated body can be bent by using the electrothermal bender based on preparation parameters.

In the embodiment of the disclosure, the electric heating bending device can be used for performing acute-angle transverse bending operation on the preheated tracheal expansion device. Fig. 5 illustrates an operational diagram of bending a body according to an exemplary embodiment of the present disclosure. In the body 50 shown in the embodiment of fig. 5, the connection between the adjacent holes 51 may have a concave portion.

In some of these embodiments, the tracheal cartilage may be bilaterally symmetric sutured under a fiberbronchoscope to precisely secure the bronchodilator device to the site of the tracheal stenosis.

The preparation method of the tracheal dilation device provided by the embodiment of the disclosure has the advantages of convenience in operation and capability of synchronously finishing tracheal correction. The tracheal expansion device prepared by the embodiment of the disclosure is good in material and tissue compatibility, high in strength, and capable of being degraded and absorbed step by step on time, so that the defects of granulation hyperplasia and blockage of the trachea caused by the conventional tracheal stent mode and the serious complications such as restenosis possibly occurring in the open trachea operation are completely avoided. The trachea shaping and correcting effect of the trachea expanding device is satisfactory, and the prognosis of the children patients is improved.

Those skilled in the art will appreciate that all or part of the steps for implementing the above embodiments are implemented as a computer program executed by a Central Processing Unit (CPU). The computer program, when executed by the central processing unit CPU, performs the above-described functions defined by the above-described system provided by the present disclosure. The program may be stored in a computer readable storage medium, which may be a read-only memory, a magnetic or optical disk, or the like.

Furthermore, it should be noted that the above-mentioned figures are merely schematic illustrations of processes included in systems according to exemplary embodiments of the present disclosure, and are not intended to be limiting. It will be readily understood that the processes shown in the above figures are not intended to indicate or limit the chronological order of the processes. In addition, it is also readily understood that these processes may be performed synchronously or asynchronously, e.g., in multiple modules.

Those skilled in the art will appreciate that the modules described above may be distributed in a method according to the description of the embodiments, or may be modified in one or more methods that are unique from the embodiments. The modules of the above embodiments may be combined into one module, or further split into multiple sub-modules.

Through the above description of the embodiments, those skilled in the art will readily understand that the exemplary embodiments described herein may be implemented by software, or by software in combination with necessary hardware. Therefore, the technical solution according to the embodiments of the present disclosure may be embodied in the form of a software product, which may be stored in a non-volatile storage medium (which may be a CD-ROM, a usb disk, a removable hard disk, etc.) or on a network, and includes several instructions to enable a computing device (which may 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.

Exemplary embodiments of the present disclosure are specifically illustrated and described above. It is to be understood that the present disclosure is not limited to the precise arrangements, instrumentalities, or implementations described herein; on the contrary, the disclosure is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.