Artificial trachea stent and artificial trachea

Abstract

The artificial tracheal stent comprises a core material, the core material is sequentially bent to form arc sections and connecting sections, the arc sections are in a C shape, the multiple arc sections are sequentially arranged in the preset direction at intervals, and the connecting sections are connected with the arc sections. And every two adjacent arc sections are connected through the corresponding connecting section. According to the artificial tracheal stent, the core material is sequentially bent to form the arc sections and the connecting sections, the horseshoe-shaped arc sections are arranged at intervals to form a bionic tubular structure similar to the tracheal structure of the human body, the artificial tracheal stent has the good mechanical property, and therefore the functions of contraction and expansion can be achieved in the breathing process, and the artificial tracheal stent is suitable for being used in the breathing process. The physiological function requirements are met.

Description

Technical Field

[0001] The present invention relates to the technical field of artificial trachea, and in particular to an artificial trachea support. The present invention also relates to an artificial trachea provided with the artificial trachea support. Background Art

[0002] Tracheal diseases such as tracheal tumors, tracheal stenosis, and traumatic damage are usually removed by surgery. The purpose of treating the disease is achieved by removing tracheal lesions and restoring ventilation function. However, the length of trachea that can be removed is limited. The maximum length of tracheal resection in adults is 4 to 6 cm. When the length of tracheal resection exceeds this length, the anastomotic tension is high, which is prone to complications such as tracheal rupture or anastomotic fistula. At this time, a suitable tracheal substitute is needed to connect the upper and lower tracheal stumps. Existing artificial tracheas usually include an artificial tracheal stent and an artificial tracheal wall coated on the outside of the artificial tracheal stent. The artificial tracheal stent is used to support the artificial tracheal wall to form a tracheal structure. However, the existing artificial tracheal stents only focus on realizing the pipeline structure, and cannot meet the contraction and expansion function of the tracheal lumen during breathing. Therefore, most of the existing artificial tracheas cannot be maturely used in clinical practice. Summary of the invention

[0003] In view of this, the present invention aims to provide an artificial tracheal stent with good mechanical properties and bionic structure, and capable of contracting and expanding during breathing to meet physiological function requirements.

[0004] To achieve the above object, the technical solution of the present invention is achieved as follows:

[0005] An artificial trachea stent comprises a core material; the core material is bent in sequence to form an arc segment and a connecting segment; the arc segment is C-shaped, a plurality of arc segments are arranged in sequence along a preset direction, and two adjacent arc segments are connected via the connecting segment.

[0006] Furthermore, the core material is a strip structure with a rectangular cross section; the width side of the cross section is parallel to the preset direction.

[0007] Furthermore, the width A of the core material is 2 to 6 mm, and the thickness H of the core material is 1 to 2 mm; and the distance B between two adjacent arc segments is 2 to 4 mm.

[0008] Furthermore, a plurality of through holes are provided on the arc end and the connecting section, and each of the through holes penetrates the core material along the thickness direction of the core material; and a diameter of each of the through holes is 0.5 to 1.5 mm.

[0009] Furthermore, the cross section of the core material is circular, and the diameter of the cross section of the core material is 0.3-0.9 mm.

[0010] Furthermore, any one end of the core material has an inner curved section that is bent and extended toward one side of the adjacent circular arc section, and an end portion of the inner curved section abuts against the adjacent circular arc section.

[0011] Furthermore, the core material is divided into a plurality of support groups, and the support group includes at least two arc segments.

[0012] Furthermore, the width L1 of the support group is 2-6 mm; and the distance L2 between two adjacent support groups is 2-4 mm.

[0013] Compared with the prior art, the present invention has the following advantages:

[0014] The artificial tracheal stent of the present invention is formed by bending the core material in sequence to form arc segments and connecting segments, and arranging the arc segments in a horseshoe shape at intervals to form a bionic tubular structure similar to the human trachea structure, and has good mechanical properties, so that it can realize the functions of contraction and expansion during breathing and meet the physiological function needs.

[0015] By setting the central angle α of the arc segment to 235-270°, it is easy to fit the shape of the trachea. By setting the core material with a rectangular cross-section strip structure, the arc segment of the core material can effectively simulate the structure of the tracheal cartilage, which has a good bionic effect.

[0016] The width side length of the core material, the thickness of the core material and the distance between two adjacent arc segments are set so that the core material has an appropriate width to simulate the width of the human tracheal cartilage. At the same time, the distance between two adjacent arc segments corresponds to the width of the ligament between the human tracheal cartilage, thereby further simulating the actual structure of the trachea and better meeting the requirements of ergonomics.

[0017] In addition, the core material can be set to a filament structure with a circular cross section. Compared with the existing tracheal substitute with a mesh structure, it only needs to be bent and formed, and the structure is simple. It is easy to manufacture to a certain extent, and further facilitates the adjustment of the size for different users to achieve personalized customization. It is also suitable for adults and children and has good applicability.

[0018] Either end of the core material has an inner curved section bent and extended toward the adjacent arc section to prevent the end of the core material from bruising human tissue.

[0019] The core material is divided into multiple support groups with a certain width, so as to effectively simulate the human tracheal cartilage. At the same time, a certain distance is left between each support group to simulate the ligament between the human tracheal cartilage, further simulate the actual structure of the trachea, and better meet the requirements of ergonomics. The width of the support group corresponds to the width of the tracheal cartilage, and the distance between two adjacent support groups corresponds to the width of the ligament between the tracheal cartilage, so that the artificial tracheal stent itself can simulate the cartilage and ligament of the human trachea, which is more in line with the requirements of ergonomics.

[0020] Another object of the present invention is to provide an artificial trachea, comprising the artificial trachea stent as described above, and an artificial trachea wall covering both the inner and outer sides of the trachea stent.

[0021] The artificial tracheal stent of the present invention has the technical advantages possessed by the above-mentioned artificial tracheal stents, and can also meet the needs of tracheal functional reconstruction. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The accompanying drawings constituting a part of the present invention are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0023] Figure 1 This is a schematic diagram of the structure of the artificial trachea stent according to the first embodiment of the present invention;

[0024] Figure 2 This is a schematic diagram of the dimensions of the arc segment of the artificial trachea stent according to the first embodiment of the present invention;

[0025] Figure 3 A schematic diagram of an implementation form of the arrangement of through holes described in Embodiment 1 of the present invention;

[0026] Figure 4 A schematic diagram of another implementation form of the arrangement of the through holes described in the first embodiment of the present invention;

[0027] Figure 5 A schematic structural diagram of an implementation form of the artificial tracheal stent according to the first embodiment of the present invention;

[0028] Figure 6 This is a schematic structural diagram of another implementation form of the artificial trachea stent according to the first embodiment of the present invention;

[0029] Description of reference numerals:

[0030] 1. Arc segment; 2. Connecting segment; 3. Inward curved segment; 4. Support group; 5. Through hole. DETAILED DESCRIPTION

[0031] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0032] In the description of the present invention, it should be noted that if there are terms indicating orientation or positional relationship such as "upper", "lower", "inner", "outer", etc., they are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention 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 cannot be understood as limiting the present invention. In addition, if there are terms such as "first", "second", etc., they are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0033] In addition, in the description of the present invention, unless otherwise clearly defined, the terms "installed", "connected", "connection" and "connector" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood in combination with specific circumstances.

[0034] The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.

[0035] Embodiment 1

[0036] The present embodiment relates to an artificial tracheal stent, which is used as a tracheal replacement to connect the upper and lower tracheal stumps during tracheal reconstruction.

[0037] like Figure 1 , Figure 2 , Figure 3 and Figure 5 As shown, in terms of overall structure, the artificial trachea stent of this embodiment includes a core material.

[0038] The core material is bent in sequence to form an arc segment 1 and a connecting segment 2. The arc segment 1 is horseshoe-shaped. There are multiple arc segments 1 arranged in sequence along a preset direction, and two adjacent arc segments 1 are connected by the connecting segment 2.

[0039] As shown in the above structure, the artificial tracheal stent of this embodiment is formed by bending the core material in sequence to form an arc segment 1 and a connecting segment 2, and the C-shaped arc segments 1 are arranged at intervals to form a bionic tubular structure similar to the human trachea structure, and has good mechanical properties, so that it can realize the functions of contraction and expansion during breathing and meet the physiological function needs.

[0040] Based on the above overall introduction, it can be understood that the human trachea is composed of a soft tube, smooth muscle fibers and connective tissue, and the tracheal cartilage is C-shaped, accounting for about 2 / 3 of the circumference of the trachea, and the notch of the tracheal cartilage faces the rear of the human body. In the artificial tracheal stent of the present embodiment, each C-shaped arc segment 1 is arranged along a preset direction to correspond to the tracheal cartilage, and the opening formed by each arc segment 1 and each connecting segment 2 corresponds to the notch 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 function of contraction and expansion during breathing, meeting the needs of physiological functions.

[0041] It should be noted that the C-shape of the arc segment 1 of the present embodiment includes shapes identical or similar to the letter "C", arc shapes, and other arc shapes, and the shapes of other normal human tracheal cartilages are identical or similar.

[0042] At the same time, when the human neck is bent, the spacing of the tracheal cartilages changes accordingly, so that the human trachea follows the bending of the neck. The tracheal stent of this embodiment has the connecting sections 2 arranged at the ends of the arc sections 1, and the connecting sections 2 correspond to the positions of the tracheal cartilage gaps. When the human neck is bent, the spacing of the arc sections 1 changes to correspond to the movement of the tracheal cartilage, and each connecting section 2 has a certain elasticity and can bend along with the movement of the arc sections 1, so that the artificial tracheal stent of this embodiment will not interfere with the movement of the neck. Compared with the traditional tubular tracheal substitute, the patient's head can move freely, and has better mobility and comfort.

[0043] In addition, a large number of reserved areas are provided between the arc segments 1 of this embodiment to provide blood supply to the attached tissue, thereby promoting tissue regeneration and facilitating the reconstruction of tracheal biological functions. In specific implementation, the arc segments 1 and the connecting segments 2 are bent to form an arc transition structure to ensure that they have good mechanical properties and prevent the connecting segments 2 from bruising tissues in the human body.

[0044] In order to make the arc segment 1 match the structure of the human tracheal hose, as shown in FIG. Figure 2 As shown, the central angle α corresponding to the arc segment 1 of this embodiment is 235-270°, so as to fit the shape of the trachea and adjust the opening of the artificial tracheal stent according to the actual situation of the patient.

[0045] In order to effectively simulate the human tracheal cartilage and improve the bionic effect of the artificial tracheal stent of this embodiment, the core material of this embodiment is a strip structure with a rectangular cross section, and the width side of the cross section is parallel to the preset direction. By setting the strip core material, the arc segment 1 of the core material can effectively simulate the structure of the tracheal cartilage and has a good bionic effect. At the same time, in the specific implementation, since the human tracheal stent of this embodiment is implanted in the human body for a long time, in order to ensure the stability of the artificial tracheal stent of this embodiment, the core material of this embodiment should be made of conventional polymer materials well known to those skilled in the art, such as polyoxymethylene (POM), etc., so that the core material of this embodiment is non-degradable and has good elasticity and effectively improves the mechanical properties of the artificial tracheal stent and maintains stability in the human body. At the same time, the core material is made of the above-mentioned polymer material, which can avoid the artificial tracheal stent of this embodiment from affecting the irradiation of radiation when the patient receives radiotherapy, thereby affecting the energy efficiency of radiation and causing a decrease in the efficacy of radiotherapy.

[0046] In order to further simulate the structure of the human trachea, such as Figure 1 As shown, the width A of the core material in this embodiment is 2-6 mm, and the thickness H of the core material is 1-2 mm, and the spacing B between two adjacent arc segments 1 is 2-4 mm, so that the core material has an appropriate width to simulate the width of the human tracheal cartilage, and the spacing between two adjacent arc segments 1 corresponds to the width of the ligament between the human tracheal cartilage, thereby further simulating the actual structure of the trachea, having good mobility and comfort, to ensure that the patient's head can move freely, and more in line with ergonomic requirements. In specific implementation, the width A of the core material and the spacing B between two adjacent arc segments 1 can be adjusted according to the size of the patient's trachea, and can match the actual size of the patient's trachea.

[0047] It is understandable that, in order to form an artificial trachea as a trachea replacement to connect the upper and lower tracheal stumps of the patient, the inner and outer sides of the artificial trachea stent of this embodiment are covered with artificial trachea walls, and the artificial trachea walls are made of collagen mesh material or patient's own tissue and cell-assisted prosthetic material. In order to make human tissue adhere to and grow on the artificial trachea stent, such as Figure 3 As shown, in this embodiment, a plurality of through holes 5 are provided on the arc end 1 and the connecting section 2, and each through hole 5 penetrates the core material along the thickness direction of the core material. Through the provision of the through holes 5, human tissue can be attached and grown on the artificial tracheal stent, thereby facilitating the repair and regeneration of the trachea and meeting the physiological function requirements.

[0048] In specific implementation, each through hole 5 is arranged in a variety of arrangements and is formed on the arc end and the connecting section. As a specific implementation method, Figure 4As shown, each through hole 5 is distributed in a lattice shape on each arc segment and each connecting end, so as to increase the number of through holes 5 and facilitate the attachment and growth of human tissue. As another specific implementation, each through hole 5 is arranged in a circuitous manner in the width direction of the core material, while ensuring the number of each through hole, the structural strength of the artificial tracheal stent of this embodiment is improved. Of course, the through holes can also be arranged in other through hole arrangements, which can ensure that there are a certain number of through holes for tissue growth and attachment, and have good structural strength.

[0049] Specifically, the diameter of each through hole 5 is 0.5-1.5 mm, which can promote the attachment and growth of human tissue on the artificial trachea stent and ensure that the artificial trachea stent has good structural strength.

[0050] In this embodiment, as another implementation form, Figure 5 As shown, the cross section of the core material of this embodiment is circular, and the diameter of the core material cross section is 0.3-0.9 mm. By setting the core material as a filament structure with a circular cross section, compared with the existing tracheal substitute with a mesh structure, it only needs to be bent and formed, and the structure is simple, which is convenient for production to a certain extent, and further facilitates the adjustment of the size for different users to achieve personalized customization. It is also suitable for adults and children, and has good applicability.

[0051] In addition, it can be understood that when the diameter of the core material is larger, its elastic coefficient is larger, and at the same time its structural strength is greater. Therefore, the diameter of the core material can be adjusted so that the structural strength and elastic coefficient of the artificial tracheal stent are consistent with the actual situation of the patient, ensuring that the artificial tracheal stent has a certain structural strength to ensure normal tracheal function while being able to bend with the patient's neck movement.

[0052] In a specific implementation, for adult patients, the diameter of the core material can be preferably set to 0.6 mm, 0.75 mm, or 0.9 mm, and for pediatric patients, the diameter of the core material can be preferably set to 0.3 mm or 0.4 mm.

[0053] In addition, the core material of this embodiment can be made of metal materials with certain elasticity and structural strength known to those skilled in the art, such as nickel-titanium alloy, zirconium-titanium alloy, Ti6Al4V alloy, memory alloy, etc., or the core material of this embodiment can also be made of the above-mentioned conventional polymer materials, such as polyoxymethylene (POM), etc. Thus, while ensuring the structural strength of the artificial tracheal stent of this embodiment, it can prevent the artificial tracheal stent of this embodiment from affecting the irradiation of radiation when the patient receives radiotherapy, thereby affecting the energy efficiency of the radiation and causing a decrease in the efficacy of radiotherapy.

[0054] Since the core material is filamentous, in order to prevent the end of the core material from causing damage to human tissue, either end of the core material of this embodiment has an inner bend section 3 that bends and extends toward the adjacent arc section 1, and the end of the inner bend section 3 abuts against the adjacent arc section 1 to prevent the end of the core material from bruising human tissue. In a specific implementation, the end of the inner bend portion can be preferably connected to the adjacent arc section 1 to strengthen the structural strength of the two ends of the artificial trachea stent, thereby ensuring the stability of the connection between the artificial trachea stent and the human trachea stump.

[0055] The arc segment 1 of this embodiment is used to simulate the cartilage of the human trachea, but the cartilage of the human trachea has a certain width, and the bionic effect of only using a single arc segment 1 is not good. Therefore, as another implementation form, Figure 6 As shown, the core material of this embodiment is divided into a plurality of support groups 4, and the support group 4 includes at least two arc segments 1. The arc segments 1 in the support group 4 are arranged relatively closely together, so that the support group 4 has a certain width, thereby effectively simulating the human tracheal cartilage. At the same time, a certain spacing is left between each support group 4 to simulate the ligaments between the human tracheal cartilage, further simulate the actual structure of the trachea, and better meet the requirements of ergonomics. In the specific implementation, in order to ensure the structural strength of the support group 4, the support group 4 is composed of four arc segments 1.

[0056] In order to further simulate the structure of the human trachea, the width L1 of the support group 4 of this embodiment is 2-6 mm, and the distance L2 between two adjacent support groups 4 is 2-4 mm. The width of the support group 4 corresponds to the width of the tracheal cartilage, and the distance between two adjacent support groups 4 corresponds to the width of the ligament between the tracheal cartilages, so that the artificial tracheal stent itself can simulate the cartilage and ligament of the human trachea, which is more in line with the requirements of ergonomics.

[0057] In summary, the artificial tracheal stent of the present embodiment is formed into an arc segment 1 and a connecting segment 2 by bending the core material in sequence, and the C-shaped arc segments 1 are arranged at intervals to form a bionic tubular structure similar to the human trachea structure, which has good mechanical properties and can thus realize the functions of contraction and expansion during breathing to meet the physiological function needs.

[0058] Embodiment 2

[0059] The present embodiment relates to an artificial trachea, which is used as a trachea replacement to connect the upper and lower trachea stumps during tracheal reconstruction.

[0060] The artificial trachea of ​​this embodiment includes the artificial trachea stent in the first embodiment and the artificial trachea wall covering the inner and outer sides of the artificial trachea stent. It has good biocompatibility, can promote the growth of human tissue, meet the contraction and expansion of the tracheal lumen during breathing, and meet the needs of tracheal functional reconstruction.

[0061] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An artificial tracheal stent, characterized in that: Includes core material; The core material is bent in sequence to form an arc segment (1) and a connecting segment (2); The circular arc segment (1) is C-shaped, and is a plurality of circular arc segments (1) arranged in sequence and at intervals along a preset direction, and two adjacent circular arc segments (1) are connected via the connecting segment (2).

2. The artificial trachea stent according to claim 1, characterized in that: The central angle α corresponding to the arc segment (1) is 235-270°.

3. The artificial trachea stent according to claim 1 or 2, characterized in that: The core material is a strip structure with a rectangular cross section; The width side of the core material is parallel to the preset direction.

4. The artificial trachea stent according to claim 3, characterized in that: The width A of the core material is 2 to 6 mm, and the thickness H of the core material is 1 to 2 mm; The distance B between two adjacent arc segments (1) is 2 to 4 mm.

5. The artificial trachea stent according to claim 3, characterized in that: A plurality of through holes (5) are provided on the arc end (1) and the connecting section (2), and each of the through holes (5) penetrates the core material along the thickness direction of the core material; The diameter of each through hole (5) is 0.5-1.5 mm.

6. The artificial trachea stent according to claim 1 or 2, characterized in that: The cross section of the core material is cylindrical, and the diameter of the cross section of the core material is 0.3-0.9 mm.

7. The artificial trachea stent according to claim 6, characterized in that: Either end of the core material has an inner curved section (3) bent and extended toward one side of the adjacent circular arc section (1), and the end of the inner curved section (3) abuts against the adjacent circular arc section (1).

8. The artificial trachea stent according to claim 7, characterized in that: The core material is divided into a plurality of support groups (4), and the support group (4) comprises at least two circular arc segments (1).

9. The artificial trachea stent according to claim 8, characterized in that: The width L1 of the support group (4) is 2 to 6 mm; The distance L2 between two adjacent support groups (4) is 2 to 4 mm.

10. An artificial trachea, characterized in that: The artificial trachea comprises the artificial trachea stent according to any one of claims 1 to 9, and an artificial trachea wall covering both the inner and outer sides of the trachea stent.

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