Tracheal stent structure and artificial trachea

Abstract

The utility model provides a tracheal stent structure and an artificial trachea. The tracheal stent structure comprises a main body, the main body comprises a plurality of supporting units which are linearly arranged at intervals; each supporting unit is of a C-shaped structure with an opening, a connecting unit is arranged between every two adjacent supporting units, and each connecting unit is of a structure with a hole. According to the tracheal stent assembly, the bionic tubular structure similar to the tracheal structure of the human body is formed by arranging the structure, so that the contraction and expansion functions can be achieved in the breathing process, and the physiological function requirements are met.

Description

Technical Field

[0001] The utility model relates to the technical field of tracheal stents, and particularly relates to a tracheal stent structure. The utility model also relates to an artificial trachea provided with the above tracheal stent structure. Background Art

[0002] Tracheal diseases such as tracheal tumors, tracheal stenosis, and traumatic damage are usually treated by surgical resection. By removing the tracheal lesion, the ventilation function is restored to achieve the purpose of treating the disease. However, the length of the trachea that can be resected is limited. The maximum length of the resected trachea in adults is 4-6 cm. When the length of the resected trachea exceeds this length, the anastomotic tension is relatively high, and complications such as tracheal rupture or anastomotic fistula are likely to occur. At this time, a suitable tracheal substitute is required to connect the upper and lower tracheal stumps. Existing artificial tracheas usually consist of tubular structures made of polymer materials. However, such artificial tracheas only focus on realizing the pipeline structure and cannot meet the contraction and expansion functions of the tracheal lumen during the breathing process. Therefore, most existing artificial tracheas cannot be maturely applied clinically. Summary of the Utility Model

[0003] In view of this, the utility model aims to provide a tracheal stent structure with a good bionic structure to meet the physiological function requirements.

[0004] To achieve the above object, the technical solution of the utility model is realized as follows:

[0005] A tracheal stent structure includes a main body; the main body includes a plurality of support units arranged at intervals in a straight line; each of the support units has an open C-shaped structure, and a connection unit is provided between adjacent support units, and the connection unit is provided with a perforated structure.

[0006] Further, the perforated structure is a mesh structure or a perforated membrane structure.

[0007] Further, the holes of the perforated membrane structure are any one of cylindrical, frustum-shaped, or hourglass-shaped.

[0008] Further, the support unit is made of titanium alloy material.

[0009] Further, the opening distance of the C-shaped structure of the support unit is 1-3 cm.

[0010] Further, the support unit is in an arc shape, and the radian is 235°-270°.

[0011] Further, the width of the support unit is 2-3 mm.

[0012] Further, the thickness of the support unit is 1-2 mm.

[0013] Furthermore, the interval between adjacent support units is 2 - 4 mm.

[0014] The present utility model further provides an artificial trachea, in which the above-mentioned tracheal stent structure is provided.

[0015] Compared with the prior art, the present utility model has the following advantages:

[0016] In the artificial trachea structure of the present utility model, by arranging a plurality of support units arranged in parallel at intervals, each of the support units has a C-shaped structure with an opening, and a hole structure is provided between adjacent support units to form a bionic tubular structure similar to the human trachea structure, so as to realize the functions of contraction and expansion during the breathing process and meet the physiological function requirements.

[0017] In addition, the opening distance of the C-shaped structure is 1 - 3 cm ， It can be better adapted to ergonomics, improving the comfort of patients and the applicability of the artificial trachea structure.

[0018] The artificial tracheal stent of the present utility model has the technical advantages of the above-mentioned artificial tracheal stent, and at the same time, it can also meet the needs of tracheal functional reconstruction. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawings constituting a part of the present utility model are used to provide a further understanding of the present utility model. The schematic embodiments and descriptions thereof of the present utility model are used to explain the present utility model and do not constitute an improper limitation to the present utility model. In the drawings:

[0020] Figure 1 is a schematic diagram of the tracheal stent structure described in Embodiment 1 of the present utility model;

[0021] Figure 2 is a schematic diagram of the tracheal stent structure described in Embodiment 2 of the present utility model;

[0022] Figure 3 is a schematic diagram of one perspective of the support unit of the tracheal stent structure described in Embodiment 1 of the present utility model;

[0023] Figure 4 is a schematic diagram of another perspective of the support unit of the tracheal stent structure described in Embodiment 1 of the present utility model;

[0024] Figure 5 is a schematic diagram of yet another perspective of the support unit of the tracheal stent structure described in Embodiment 1 of the present utility model;

[0025] Figure 6Schematic cross-sectional view of optional shapes of the first through-hole in the hole structure of the tracheal stent structure described in Embodiment 1 of the present utility model;

[0026] Explanation of reference numerals:

[0027] 1. Support unit;

[0028] 2. Connection unit; 201. First through-hole; 202. Second through-hole;

[0029] W. Opening spacing; X. Thickness of the support unit; Y. Width of the support unit. Detailed implementation manners

[0030] It should be noted that, without conflict, the embodiments in the present utility model and the features in the embodiments may be combined with each other.

[0031] In the description of the present utility model, it should be noted that if terms indicating orientation or positional relationship such as "upper", "lower", "inner", "outer", etc. appear, they are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present utility model. In addition, if terms such as "first", "second", etc. appear, they are also only for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0032] In addition, in the description of the present utility model, unless otherwise clearly defined, the terms "installation", "connection", "connection", "connecting member" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection or an electrical connection; it may be directly connected, or indirectly connected through an intermediate medium, and may be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood in combination with specific situations.

[0033] In addition, in the embodiments of the present utility model, the membrane structure mentioned refers to a polymer biofilm, a skin flap, or other lumen lining materials for artificial trachea production covering the tracheal stent assembly.

[0034] Hereinafter, the present utility model will be described in detail with reference to the drawings and in combination with embodiments.

[0035] Embodiment 1

[0036] This embodiment relates to a tracheal stent structure, including a main body; the main body includes a plurality of support units 1 arranged linearly and spaced apart; each of the support units 1 has a C-shaped structure with an opening, and a connection unit 2 is provided between adjacent support units 1, and the connection unit 2 is a perforated structure. To form a bionic tubular structure similar to the human tracheal structure, so as to be able to realize the functions of contraction and expansion during the breathing process and meet the physiological function requirements. There are 5 support units 1 in this embodiment. Of course, it can also be set to an appropriate number according to actual needs.

[0037] Specifically based on the above overall introduction, in combination with Figure 1 shown for illustration. The human trachea is composed of a soft tube, smooth muscle fibers and connective tissue. The notch of the tracheal cartilage faces the back of the human body. In the tracheal stent structure of this embodiment, the support unit 1 with an open C-shaped structure corresponds to the tracheal cartilage, and the opening of each support unit 1 corresponds to the notch part of the cartilage in the human trachea, so as to form a better bionic structure. On the one hand, it can effectively connect the stump of the human trachea, fully simulate the normal tracheal cartilage ring, and can realize the functions of contraction and expansion during the breathing process, meeting the physiological function requirements.

[0038] A connection unit 2 is provided between adjacent support units 1, and the connection unit 2 is a perforated structure. On the one hand, the connection unit 2 provides the connection combination of the support units 1. On the other hand, by using the structural characteristics of its through holes, more points for planting tissue cells can be provided. The cell division and growth are distributed on the surface of the connection unit 2, which can form a more comfortable transition area between the tracheal stent structure and other human tissues. As Figure 1 shown, the perforated structure of the connection unit 2 in this embodiment is a membrane structure with a plurality of first through holes 201. The first through holes 201 are circular holes, and the membrane is fixed on the support unit 1. The inner wall of the first through hole 201 provides the initial planting and growth space for tissue cells.

[0039] The hole structure of the first through hole 201 of the above-mentioned perforated membrane structure is any one of a cylindrical shape, a frustum shape or an hourglass shape, so as to facilitate the planting of tissue cells on it. The hole structure of the first through hole 201 in this embodiment can be a circular through hole with a constant aperture, such as Figure 6 shown as type a; it can also be a tapered hole with a large end and a small end and a linear transition, such as Figure 6 shown as type b; it can also be an hourglass-shaped hole with a thin middle and thick ends, such as Figure 6 shown as type c. The a-type hole is convenient to process and easy to form, while the b-type and c-type are beneficial to improving the strength of the membrane structure and the firm adhesion of the planted cells. When the hole type is b-type or c-type, the minimum aperture is about 400 - 600 μm, the maximum aperture is about 1000 - 1500 μm, and the porosity of the membrane structure is about 60 - 80%, which is beneficial to the firm adhesion of tissue cells.

[0040] The above-mentioned porous structure preferably adopts a biodegradable polymer polydioxanone (PDO) material or a biodegradable polymer polylactic acid material (PLA). The polydioxanone (PDO) material is a synthetic absorbable colorless polyester. PDO degrades by hydrolysis and is completely metabolized in the body. It is generally considered non-antigenic and non-pyrogenic, and induces minimal tissue reaction during the absorption process after implantation. PDO is a semi-crystalline polymer, about 55% crystalline, with a glass transition temperature range of -10°C to 0°C and a melting temperature of 110–115°C. PLA is a polymer material derived from biomass, which ultimately forms carbon dioxide and water after biodegradation, and has good biocompatibility and biodegradability. The degradation rate of PLA is controlled by its crystallinity, molecular weight, hydrophobicity of monomers, etc. The higher the crystallinity, the slower the degradation; the smaller the molecular weight, the faster the degradation. More preferably, poly(lactic-co-glycolic acid) (PLGA) is adopted, which is a biodegradable functional polymer organic compound formed by random polymerization of two monomers, lactic acid and glycolic acid.

[0041] In the support unit 1 of the artificial tracheal stent structure of this embodiment Figure 1 The design adopts a biodegradable material. When a biodegradable material is used, in order to have more areas for implanting cells and more uniform tissue distribution, the support unit 1 can also have a pore structure similar to that on the membrane. The size of the pores conforms to Figure 6 each case, and the pore depth is set according to the thickness of the support unit 1, as shown in Figure 3 and Figure 5 shown.

[0042] As a preferred implementation method, as shown in Figure 4 the opening spacing W of the C-shaped structure of the above-mentioned support unit 1 is 1-3 cm. This opening distance has a bionic structure adapted to the general human trachea, and the specific size can be flexibly set within this range according to the age of the patient. When the patient implants the tracheal stent structure of this embodiment, the discomfort of the patient can be reduced. Further, the support unit 1 is in an arc shape, and the radian is 235°-270°. In this embodiment, the radian and the opening distance are cooperatively limited to determine the specific bending shape of the support unit 1, which has a good effect on improving the comfort of the patient.

[0043] Further, as shown in Figure 5As shown, the width Y of the above-mentioned support unit 1 is 2 to 3 mm. The width of the support unit 1 is a parameter representing the thickness of the support unit 1 in the linearly arranged direction of each support unit 1. On the one hand, the width of the support unit 1 cannot be too small, otherwise the stiffness of the tracheal stent structure is too low and it is easy to deform. On the other hand, the width of the support unit 1 cannot be too large, otherwise the stiffness of the tracheal stent structure is too high, which will limit the activities of the patient after implanting the tracheal stent structure of this embodiment. Therefore, based on long-term clinical experience, the inventor calculated and found that the width of the support unit 1 in this embodiment is 2 to 3 mm, which is a more appropriate range.

[0044] In order to further improve the comfort of implantation, as Figure 4 shown, the thickness X of the support unit 1 in this embodiment is 1 to 2 mm. In addition, the interval between adjacent support units 1 is 2 - 4 mm. The distance represented by this interval is the distance between the lower edge of the previous support unit 1 and the upper edge of the next support unit 1. This range of the interval distance is also beneficial to the strength cooperation between the support units 1.

[0045] Embodiment Two

[0046] This embodiment relates to a tracheal stent structure, whose basic structure and materials are similar to those of Embodiment One. The difference is that the perforated structure of the connecting unit 2 between the support units 1 is a mesh hole formed by network interweaving to form the second through hole 202. The mesh hole has a greater bending flexibility than the round hole and can provide a more comfortable feeling. Figure 2 The shown support unit 1 is made of titanium alloy material, and the structure between the supports is a mesh structure, which is a square grid. The side length of the square grid hole is 1 - 2 mm. Titanium alloy has shape memory characteristics and good biocompatibility, avoiding adverse reactions in the human body. It can be understood that during the operation of implanting this artificial tracheal stent into the patient's body, this stent is prone to deformation when sutured and connected to the tracheal stump (such as the tension of the tracheal stump), or the artificial tracheal stent deforms due to external forces on the patient's neck after the operation, thereby reducing the tracheal reconstruction effect. Therefore, the support unit 1 utilizes the shape memory characteristics of the titanium alloy material to return to its original state under the action of the human body temperature after the operation, reducing the implantation difficulty of the artificial tracheal stent and ensuring the normal function of the trachea after the operation. In specific implementation, the deformation temperature of the support unit 1 can be preferably set to 3 - 7 °C, and the recovery temperature can be preferably set to 36 - 37 °C, so that the artificial tracheal stent can return to its original structure under the action of body temperature.

[0047] Embodiment Three

[0048] The present utility model further proposes an artificial trachea, in which the above-mentioned tracheal stent structure is provided, and the inner membrane of the lumen can be a biological membrane, a skin flap or other artificial material membranes for making the lining.

[0049] The artificial trachea of this embodiment improves the applicability of the artificial trachea by adopting the tracheal stent structure in Embodiment 1 or Embodiment 2.

[0050] The above are only the preferred embodiments of the present utility model and are not intended to limit the present utility model. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present utility model shall be included within the protection scope of the present utility model.

Claims

1. A tracheal stent structure, characterized in that: It includes a main body; the main body includes a plurality of support units (1) arranged at intervals in a straight line; each of the support units (1) has a C-shaped structure with an opening, and a connecting unit (2) is provided between adjacent support units (1), and the connecting unit (2) is a perforated structure for installing a membrane structure.

2. The tracheal stent structure according to claim 1, characterized in that: The perforated structure is a mesh structure or a perforated membrane structure.

3. The tracheal stent structure according to claim 2, characterized in that: The holes of the perforated membrane structure are any one of cylindrical, frustum-shaped or hourglass-shaped.

4. The tracheal stent structure according to claim 1, characterized in that: The support unit (1) is made of titanium alloy material or biodegradable material.

5. The tracheal stent structure according to claim 1, characterized in that: The opening distance of the C-shaped structure of the support unit (1) is 1-3 cm.

6. The tracheal stent structure according to claim 5, characterized in that: The support unit (1) is in an arc shape, and the radian is 235°-270°.

7. The tracheal stent structure according to claim 6, characterized in that: The width of the support unit (1) is 2-3 mm.

8. The tracheal stent structure according to claim 6, characterized in that: The thickness of the support unit (1) is 1-2 mm.

9. The tracheal stent structure according to claim 6, characterized in that: The interval between adjacent support units (1) is 2-4 mm.

10. An artificial trachea, characterized in that: The artificial trachea is provided with the tracheal stent structure according to any one of claims 1 to 9.

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