A bionic composite artificial trachea and its preparation method

Abstract

The present invention provides a bionic composite artificial trachea, comprising: an artificial tracheal wall; the artificial tracheal wall comprising a biological patch layer and an absorbable biomaterial layer from the inside out; a tracheal stent disposed on the outside of the artificial tracheal wall; and a gasket wrapping the edge of the tracheal stent. The bionic composite artificial trachea, with the biological patch layer and the absorbable biomaterial layer as the artificial tracheal wall, combined with the arrangement of the tracheal stent, not only provides good ventilation, but also can slightly deform with airway pressure and has a certain degree of elasticity, so that the patient's head can move freely, without the trouble of having to fix the neck after traditional tracheal surgery; at the same time, the arrangement of the gasket can prevent the end of the tracheal stent from bruising surrounding organs due to friction during the initial implantation period; in summary, the bionic composite artificial trachea provided by the present invention can be applied clinically and can solve the problem of the lack of an effective tracheal substitute for primary tracheal reconstruction during the resection of an extra-long trachea in current tracheal surgery in a single operation.

Description

Technical Field

[0001] The present invention relates to the technical field of artificial trachea, and more particularly to a bionic composite artificial trachea and a preparation method thereof. Background Art

[0002] The treatment of tracheal diseases such as tracheal tumors and tracheal stenosis is still mainly based on surgical resection. By removing tracheal lesions and restoring ventilation function, the purpose of treating the disease and improving symptoms can be achieved. However, the length of the trachea that can be removed is limited. The maximum length of the trachea removed in adults is 4-6 cm. When the resected trachea exceeds this length, in situ anastomosis is extremely difficult. At this time, a suitable tracheal substitute is needed to connect the upper and lower tracheal stumps. However, there are currently no mature tracheal substitutes that can be used in thoracic surgery for tracheal reconstruction. Therefore, when the trachea involved by tumors or lesions exceeds the critical range, palliative surgery is often chosen; ultimately, the diseased trachea cannot be completely removed, making it difficult to achieve the ideal treatment effect.

[0003] Since the 1980s, domestic and foreign scholars have conducted extensive research on artificial tracheas and proposed four methods for tracheal reconstruction: ① Polymer material artificial trachea, generally composed of a tubular structure woven from polymer materials; this type of tracheal reconstruction solution is simple and does not require immunosuppressants, but its disadvantage is that the tube wall cannot effectively form a biochemical barrier after implantation, so this solution has gradually been abandoned. ② Allogeneic tracheal transplantation: This solution has the advantage of natural tracheal tissue structure, reliable mechanical properties, and basically no need to worry about epithelialization issues; however, the disadvantages of this method are also very obvious: a donor is required, and the material is relatively limited; and after implantation, the patient needs to take immunosuppressants. At this time, the bacterial environment in the trachea can easily cause infection at the implantation site and donor corruption. ③ Autologous tissue transplantation: This typically involves tubularized autologous tissue, such as pericardium or blood vessels, to provide a sealed lining, combined with an external stent or cartilage for external support. This approach avoids the immunosuppression associated with allogeneic tracheal transplantation, but epithelialization of the reconstructed trachea is difficult, resulting in poor strength and stability. Furthermore, damage to the material and donor site limits its widespread application. ④ Tissue-engineered tracheal transplantation is currently a hot topic of research for both domestic and international researchers. Numerous solutions for tissue-engineered tracheal transplantation have been proposed, demonstrating promising potential through in vivo experiments. Undoubtedly, the most notable approach is the decellularized artificial trachea combined with autologous cell transplantation developed by Italian surgeon Paolo Macchiarini. Beginning in 2008, Macchiarini used a detergent-enzyme method to create decellularized human tracheas, implanted them with recipient airway epithelial cells and mesenchymal stem cell-derived chondrocytes, and then implanted them into the patient's tracheal defect. Initial follow-up showed no signs of rejection in the recipients, and immunosuppression was not required. However, Macchiarini's plan eventually resulted in several serious surgical complications, and the Karolinska University Hospital where he worked issued a statement in 2017 declaring his plan a failure.

[0004] In recent years, the Zhao's artificial trachea, invented by Professor Zhao Fengrui of the Department of Thoracic Surgery at Beijing Jiangong Hospital, has become one of the most successful artificial tracheas in clinical practice. The Zhao's artificial trachea requires a two-stage surgical procedure for tracheal reconstruction: in the first stage, a memory alloy mesh is placed in the neck tissue, and the incision is closed with absorbable sutures. Twenty days later, the mesh is freed from the muscle and vascular pedicle, forming a "sandwich-style" pedicled artificial trachea that includes the skin. A second stage is then performed to remove the diseased trachea, and the artificial trachea is connected to the upper and lower tracheal stumps, completing the implantation of the artificial trachea. Seven patients have been reported using the device; three with malignant tumors died within a year, while the remaining four with benign diseases have all survived long-term, achieving biological union with their native trachea. However, the maximum length of diseased trachea resection used in the Zhao's artificial trachea reported in the literature was 7.8 cm, and the reconstruction length was 4.2 cm, which still cannot meet the problem of tracheal reconstruction after resection of a longer diseased trachea. On the other hand, the Zhao's artificial trachea requires staged surgery. First, a set of metal stents must be pre-buried in the body for incubation so that it is covered with autologous tissue, and then a second stage of tracheal resection and reconstruction surgery is performed.

[0005] In summary, the traditional polymer material artificial trachea is difficult to form an effective biochemical barrier, so this scheme has been gradually abandoned. Allogeneic tracheal transplantation requires a donor, so the material is relatively limited, and the patient needs to take immunosuppressants after implantation. At this time, the bacterial environment in the trachea can easily cause infection at the implantation site and damage to the donor, making it difficult to be actually applied in clinical practice. Autologous tissue transplantation has the problems of limited material acquisition and damage to the donor site, which also limits its application in the reconstruction of longer artificial tracheas. As for the most promising tissue engineering trachea, it is still in the basic research stage and it is difficult to meet the requirements of clinical application in the short term. Finally, the Zhao's artificial trachea, which has been successfully used in clinical practice, still has several major shortcomings: ① The tracheal reconstruction length can only meet the tracheal reconstruction of 4.2 cm, and cannot meet the reconstruction of ultra-long tracheal lesions after resection. ② It requires two or more stages of surgery at different locations, which greatly increases the patient's surgical trauma, hospitalization time, and treatment costs; ③ Since staged surgery is required, patients have to wait 20-80 days, so the artificial trachea cannot meet the needs of emergency tracheal reconstruction surgery; ④ The metal stent material used in the artificial trachea will block X-rays in imaging, and obvious metal artifacts will be produced during imaging examinations, which is not conducive to postoperative CT evaluation; ⑤ Since the artificial trachea requires two-stage surgery, the length of the artificial trachea is determined in the first stage of surgery, and the actual length of the diseased trachea removed in the second stage of surgery is determined based on a rapid intraoperative pathological examination. The progression of the disease itself also affects the length of the diseased trachea removed. Therefore, if a length mismatch occurs in the second stage of surgery, the difficulty and risk of the surgery will be greatly increased. Summary of the Invention

[0006] In view of this, the purpose of the present invention is to provide a bionic composite artificial trachea and a preparation method thereof. The bionic composite artificial trachea provided by the present invention can be clinically applied and can solve the problem of the lack of effective tracheal substitutes for one-stage tracheal reconstruction during ultra-long tracheal resection in current tracheal surgery in one operation.

[0007] The present invention provides a bionic composite artificial trachea, comprising:

[0008] An artificial tracheal wall; the artificial tracheal wall comprises, from the inside out, a biological patch layer and an absorbable biological material layer;

[0009] a tracheal stent disposed on the outside of the artificial tracheal wall;

[0010] Wrap the gasket around the edge of the tracheal stent.

[0011] Preferably, the biological patch layer is selected from a bovine pericardium patch layer or an autologous pericardium patch layer;

[0012] The thickness of the biological patch layer is ≤2 mm.

[0013] Preferably, the absorbable biomaterial layer is selected from a polyglycolic acid patch layer, a polylactic acid patch layer, a poly-L-lactic acid patch layer, a polyglycolic acid patch layer or a polylactic-glycolic acid patch layer;

[0014] The thickness of the absorbable biomaterial layer is ≤1 mm.

[0015] Preferably, the tracheal stent is a plurality of carbon fiber C-shaped external stents sewn side by side to the outside of the artificial tracheal wall.

[0016] Preferably, the carbon fiber C-shaped outer bracket has a width of 3 mm to 12 mm and a thickness of ≤ 4 mm;

[0017] The interval between two adjacent carbon fiber C-shaped outer brackets is 5 mm to 10 mm.

[0018] Preferably, the tracheal stent is a carbon fiber integrated external stent that is entirely wrapped around the outside of the artificial tracheal wall.

[0019] Preferably, the thickness of the carbon fiber integrated outer bracket is ≤4 mm.

[0020] Preferably, the gasket is selected from polyester felt pad, Teflon patch, polypropylene patch, expanded polytetrafluoroethylene patch or polyester patch;

[0021] The thickness of the gasket is ≤3mm.

[0022] The present invention also provides a method for preparing the bionic composite artificial trachea described in the above technical solution, comprising the following steps:

[0023] a) Overlaying an absorbable biomaterial layer on a biological patch layer, then evenly wrapping one side of the biological patch layer around a mold identical to the native trachea, and sealing the mold by cutting and suturing to obtain an artificial tracheal wall; then placing a tracheal stent on one side of the absorbable biomaterial layer; and finally wrapping the edge of the tracheal stent with a gasket to obtain a biomimetic composite artificial trachea.

[0024] Preferably, after wrapping the edge of the tracheal stent with the gasket in step a), the method further comprises:

[0025] The obtained bionic composite artificial trachea was covered with free autologous tissue.

[0026] The present invention provides a bionic composite artificial trachea, comprising: an artificial tracheal wall; the artificial tracheal wall comprising a biological patch layer and an absorbable biomaterial layer from the inside out; a tracheal stent arranged outside the artificial tracheal wall; and a gasket wrapping the edge of the tracheal stent. Compared with the prior art, the bionic composite artificial trachea provided by the present invention uses a biological patch layer and an absorbable biomaterial layer as the artificial tracheal wall. The biological patch layer provides a closed lumen, and the absorbable biomaterial layer can enhance the adhesion ability of autologous tissue on the artificial tracheal wall, further forming biological fixation and reducing the probability of infection and rupture of the artificial trachea. Combined with the setting of the tracheal stent, it can not only achieve good ventilation, but also can be slightly deformed with airway pressure. Due to its bionic design, the artificial trachea has a certain degree of elasticity, so the patient's head can move freely, without the trouble of fixing the neck after traditional tracheal surgery. At the same time, the setting of the gasket can prevent the end of the tracheal stent from bruising the surrounding organs due to friction in the early stage of implantation. In summary, the bionic composite artificial trachea provided by the present invention can be clinically applied and can be used in emergency surgery without the need to wait for surgery in stage II. It can solve the problem of no effective tracheal substitute for one-stage tracheal reconstruction during super-long tracheal resection in current tracheal surgery in one operation.

[0027] In addition, the preparation method provided by the present invention is simple and easy to control; and the preparation process can be organically combined with tracheal surgery. During the operation, the size and length of the bionic composite artificial trachea can be adjusted according to the actual length and diameter parameters, avoiding the disadvantages of mismatch of pre-made finished products and improving the adaptability of the artificial trachea during surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 A schematic diagram of the structure of the bionic composite artificial trachea provided in Example 1;

[0029] Figure 2 This is a schematic diagram of the resection of an overlong diseased trachea during the operation in Example 1;

[0030] Figure 3 This is a schematic diagram of the structure of an artificial tracheal wall made of a biological patch and absorbable biomaterials in Example 1;

[0031] Figure 4 This is a schematic diagram of anastomosing an artificial trachea with the upper and lower stumps of the trachea in Example 1;

[0032] Figure 5 This is a schematic diagram of Example 1, wherein a C-shaped external stent is used to suspend the artificial tracheal wall and is protected by a felt pad;

[0033] Figure 6 Schematic diagram of the transfer of the vascularized greater omentum to the periphery of the artificial trachea in Example 1;

[0034] Figure 7 The preoperative CT images and bronchoscopic examination results of Example 1;

[0035] Figure 8 This is a real picture of the resection of the diseased trachea during the operation in Example 1;

[0036] Figure 9 This is a real picture of the artificial trachea implantation surgery in Example 1;

[0037] Figure 10 This is the CT image after surgery in Example 1;

[0038] Figure 11 The results of bronchoscopy after surgery in Example 1 are as follows;

[0039] Figure 12 This is the preoperative CT 3D reconstruction data and 3D printed model of Example 2;

[0040] Figure 13 This is a real picture of the autologous pericardium repairing tracheal defect in Example 2;

[0041] Figure 14 This is a real picture of the integrated tracheal external stent in Example 2;

[0042] Figure 15 The bronchoscopic results of Example 2 on the day after surgery (left picture) and six months after implantation (right picture) are shown. DETAILED DESCRIPTION

[0043] The following will clearly and completely describe the technical solutions of the present invention in conjunction with the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0044] The present invention provides a bionic composite artificial trachea, comprising:

[0045] An artificial tracheal wall; the artificial tracheal wall comprises, from the inside out, a biological patch layer and an absorbable biological material layer;

[0046] a tracheal stent disposed on the outside of the artificial tracheal wall;

[0047] Wrap the gasket around the edge of the tracheal stent.

[0048] In the present invention, the bionic composite artificial trachea includes an artificial tracheal wall, a tracheal stent and a gasket. In the present invention, the artificial tracheal wall includes a biological patch layer and an absorbable biological material layer from the inside out. In the present invention, the biological patch layer is preferably selected from a bovine pericardium patch layer or an autologous pericardium patch layer; wherein the autologous pericardium patch layer is made of an autologous pericardium material; and the bovine pericardium patch layer is made of a xenogeneic biological patch material that has been decellularized and de-immunized. In the present invention, the tensile strength of the biological patch layer is preferably ≥4.5N / mm 2 In the present invention, the thickness of the biological patch layer is preferably ≤2 mm.

[0049] In the present invention, the absorbable biomaterial layer is used to enhance the adhesion of the biological patch layer to the surrounding autologous tissue, thereby preventing artificial tracheal implantation failure due to leakage from suture holes. In the present invention, the absorbable biomaterial layer is preferably selected from a polyglycolic acid patch layer, a polylactic acid patch layer, a poly-L-lactic acid patch layer, a polyglycolic acid patch layer, or a polylactic-co-glycolic acid patch layer, more preferably a polyglycolic acid patch layer. The present invention does not particularly limit the source of the absorbable biomaterial layer; commercially available products familiar to those skilled in the art can be used. In the present invention, the absorbable biomaterial layer preferably has a thickness of ≤1 mm.

[0050] In the present invention, the tracheal stent is positioned outside the artificial tracheal wall, providing an external overhang and supporting structure to prevent collapse due to changes in airway pressure. The tracheal stent preferably has the following properties: low immunogenicity; sufficient support strength and elasticity; good durability; low material density and X-ray resistance; and good tissue compatibility, allowing for the attachment and growth of autologous soft tissue.

[0051] In a preferred embodiment of the present invention, the tracheal stent is a plurality of carbon fiber C-shaped external stents sutured side by side to the outside of the artificial tracheal wall; it is mainly used for ultra-long tracheal reconstruction. In the present invention, the carbon fiber C-shaped external stent adopts a bionic design of tracheal cartilage rings and is arranged on the outside of the artificial tracheal wall by suturing. In the present invention, the width of the carbon fiber C-shaped external stent is preferably 3mm to 12mm, more preferably 4mm to 8mm; the thickness is preferably ≤4mm. In the present invention, the interval between two adjacent carbon fiber C-shaped external stents is preferably 5mm to 10mm.

[0052] In another preferred embodiment of the present invention, the tracheal stent is a one-piece carbon fiber external stent that is entirely wrapped around the outside of the artificial tracheal wall; it is primarily used for repairing tracheal defects with smaller areas. In the present invention, the one-piece carbon fiber external stent is integrally designed and is sutured to the outside of the artificial tracheal wall. In the present invention, the thickness of the one-piece carbon fiber external stent is preferably ≤4 mm.

[0053] In the present invention, the gasket wraps around the edge of the tracheal stent to prevent the end of the tracheal stent from bruising surrounding organs due to friction during the initial implantation phase. In the present invention, the gasket is preferably selected from a polyester felt pad, a Teflon patch, a polypropylene patch, an expanded polytetrafluoroethylene patch, or a polyester patch, with a polyester felt pad being more preferred. The present invention does not particularly limit the source of the gasket; commercially available products familiar to those skilled in the art can be used. In the present invention, the gasket preferably has a thickness of ≤3 mm.

[0054] The bionic composite artificial trachea provided by the present invention uses a biological patch layer and an absorbable biomaterial layer as the artificial tracheal wall. The biological patch layer provides a closed lumen, and the absorbable biomaterial layer can enhance the adhesion ability of autologous tissue on the artificial tracheal wall, further forming biological fixation and reducing the probability of infection and rupture of the artificial trachea. Combined with the setting of the tracheal stent, it can not only achieve good ventilation, but also be slightly deformed with airway pressure. Due to its bionic design, the artificial trachea has a certain degree of elasticity, so the patient's head can move freely, without the trouble of fixing the neck after traditional tracheal surgery. At the same time, the setting of the gasket can prevent the end of the tracheal stent from bruising surrounding organs due to friction in the early stage of implantation. In summary, the bionic composite artificial trachea provided by the present invention can be clinically applied and can be used in emergency surgery without the need to wait for surgery in stage II. It can solve the problem of no effective tracheal substitute for one-stage tracheal reconstruction when an extra-long trachea is removed in current tracheal surgery in one operation.

[0055] The present invention also provides a method for preparing the bionic composite artificial trachea described in the above technical solution, comprising the following steps:

[0056] a) Overlaying an absorbable biomaterial layer on a biological patch layer, then evenly wrapping one side of the biological patch layer around a mold identical to the native trachea, and sealing the mold by cutting and suturing to obtain an artificial tracheal wall; then placing a tracheal stent on one side of the absorbable biomaterial layer; and finally wrapping the edge of the tracheal stent with a gasket to obtain a biomimetic composite artificial trachea.

[0057] The present invention first covers the biopatch layer with an absorbable biomaterial layer, and then evenly wraps a mold identical to the autologous trachea with one side of the biopatch layer. After cutting and suturing, an artificial tracheal wall is obtained. In the present invention, the absorbable biomaterial layer and the biopatch layer are the same as those in the above-mentioned technical solution and will not be described in detail here. The present invention uses the length of the tracheal defect after resection of the diseased trachea during surgery and the diameter of the autologous trachea as parameters to design a mold identical to the autologous trachea and further prepare an artificial tracheal wall. The present invention has no special restrictions on the design method, and the 3D printing technical solution familiar to those skilled in the art can be used.

[0058] In the present invention, the cutting, suturing and sealing device preferably adopts a surgical cutting and suturing instrument well known to those skilled in the art. After cutting, suturing and sealing, an artificial tracheal wall with a size corresponding to that of the native trachea is obtained.

[0059] After obtaining the artificial tracheal wall, the present invention sets a tracheal stent on one side of the absorbable biomaterial layer of the artificial tracheal wall; finally, wraps the edge of the tracheal stent with a gasket to obtain a biomimetic composite artificial trachea. In the present invention, the tracheal stent and gasket are the same as those in the above technical solution and will not be repeated here. In the present invention, the process of setting the tracheal stent is taken as an example of a carbon fiber C-shaped external stent, and is preferably specifically as follows:

[0060] Multiple carbon fiber C-shaped external stents are secured to the periphery of the artificial trachea with interrupted sutures, wrapping around the anterior and left and right walls to form an external suspension for the trachea. The present invention does not specifically limit the material used for the sutures; surgical sutures familiar to those skilled in the art can be used.

[0061] In the present invention, the process of wrapping the edge of the tracheal stent with the gasket is preferably specifically as follows:

[0062] Take the gasket and cut it to the appropriate length to wrap and protect the edge (end) of the tracheal stent to prevent it from injuring the surrounding organs.

[0063] In the present invention, after wrapping the edge of the tracheal stent with a gasket, the method preferably further comprises:

[0064] The obtained bionic composite artificial trachea was covered with free autologous tissue.

[0065] The bionic composite artificial trachea provided by the present invention has the following advantages:

[0066] ① Functional bionic design: The artificial tracheal wall is made of a biological patch layer and an absorbable biomaterial layer, combined with a tracheal stent with a certain degree of elasticity. It not only enables good ventilation, but also can deform slightly with airway pressure. In addition, the carbon fiber C-shaped external stent adopts the bionic design of the tracheal cartilage ring, avoiding the stress of the rigid implant on the dorsal esophagus of the trachea. When the defect area is small, the overall design of the carbon fiber integrated external stent is adopted, and the stent effect is better.

[0067] ② Adaptability in appearance: The preparation process of the bionic composite artificial trachea can be organically combined with tracheal surgery. During the operation, the size and length of the bionic composite artificial trachea can be adjusted according to the actual length and diameter parameters, avoiding the disadvantage of mismatch of pre-made finished products and improving the adaptability of the artificial trachea during surgery.

[0068] ③ Comfort during exercise: Due to its bionic design, the artificial trachea has a certain degree of elasticity, so the patient's head can move freely without the trouble of having to fix the neck after traditional tracheal surgery.

[0069] ④ Stability in connection: Through the combination of the biological patch layer and the absorbable biomaterial layer, the biological patch layer provides a closed lumen, while the absorbable biomaterial layer can enhance the adhesion ability of autologous tissue to the artificial trachea wall, further forming biological fixation and reducing the chance of infection and rupture of the artificial trachea.

[0070] ⑤ Convenience of clinical evaluation: The tracheal stent used in the present invention is made of low-density material, which does not block radiation. Therefore, no artifacts will be generated during CT examination to interfere with image judgment, which is conducive to accurate evaluation after surgery.

[0071] ⑥ Emergency use in clinical practice: The bionic composite artificial trachea provided by the present invention can be clinically applied and used in emergency surgery without the need for a Phase II waiting period for surgery. It can solve the problem of the lack of an effective tracheal substitute for primary tracheal reconstruction during the current tracheal surgical procedure when an extra-long trachea is removed in a single operation.

[0072] The present invention provides a bionic composite artificial trachea, comprising: an artificial tracheal wall; the artificial tracheal wall comprising a biological patch layer and an absorbable biomaterial layer from the inside out; a tracheal stent arranged outside the artificial tracheal wall; and a gasket wrapping the edge of the tracheal stent. Compared with the prior art, the bionic composite artificial trachea provided by the present invention uses a biological patch layer and an absorbable biomaterial layer as the artificial tracheal wall. The biological patch layer provides a closed lumen, and the absorbable biomaterial layer can enhance the adhesion ability of autologous tissue on the artificial tracheal wall, further forming biological fixation and reducing the probability of infection and rupture of the artificial trachea. Combined with the setting of the tracheal stent, it can not only achieve good ventilation, but also can be slightly deformed with airway pressure. Due to its bionic design, the artificial trachea has a certain degree of elasticity, so the patient's head can move freely, without the trouble of fixing the neck after traditional tracheal surgery. At the same time, the setting of the gasket can prevent the end of the tracheal stent from bruising the surrounding organs due to friction in the early stage of implantation. In summary, the bionic composite artificial trachea provided by the present invention can be clinically applied and can be used in emergency surgery without the need to wait for surgery in stage II. It can solve the problem of no effective tracheal substitute for one-stage tracheal reconstruction during super-long tracheal resection in current tracheal surgery in one operation.

[0073] In addition, the preparation method provided by the present invention is simple and easy to control; and the preparation process can be organically combined with tracheal surgery. During the operation, the size and length of the bionic composite artificial trachea can be adjusted according to the actual length and diameter parameters, avoiding the disadvantages of mismatch of pre-made finished products and improving the adaptability of the artificial trachea during surgery.

[0074] In order to further illustrate the present invention, the following examples are provided for detailed description. The raw materials used in the following examples of the present invention are all commercially available commodities.

[0075] Example 1

[0076] Carbon fiber C-shaped external stent combined with bovine pericardial patch to make artificial trachea for tracheal reconstruction after ultra-long (8.6 cm) tracheal resection:

[0077] See also Figure 1 As shown, Figure 1 Schematic diagram of the structure of the bionic composite artificial trachea provided in Example 1; wherein the white part is the biological patch layer, and the sky blue part is the absorbable biomaterial layer, which covers the outer periphery of the biological patch layer. The two form a closed artificial tracheal wall (tubular object) and are manufactured with corresponding diameters and lengths according to actual needs during surgery; multiple carbon fiber C-shaped external stents are sutured side by side to the outer periphery of the artificial tracheal wall, and each carbon fiber C-shaped external stent has a width of 4mm to 8mm and an interval of 5mm to 10mm (depending on the specific situation during surgery); the white strips are polyester felt pads, which wrap the two ends of the carbon fiber C-shaped external stent to prevent the ends of the carbon fiber C-shaped external stent from bruising the surrounding organs due to friction during the initial implantation.

[0078] The specific preparation steps are as follows:

[0079] (1) The diseased trachea should be removed according to the patient's condition and the actual situation during the operation; for example, in this embodiment, the upper and lower margins of the trachea should be removed ( Figure 2 ) Send for intraoperative rapid pathology examination. If the cutting margin is positive, the tracheal stump should be removed until the rapid pathology examination reports that the cutting margin is negative.

[0080] (2) Prepare an artificial tracheal wall based on the length of the tracheal defect after resection of the diseased trachea during surgery and the diameter of the autologous trachea. First, lay the biological patch flat on a sterile surface with the smooth side facing down, and cover the biomaterial on top of the biological patch. If the size of the biomaterial covering is not enough, multiple pieces can be spliced ​​together. Then, take a cylinder with the same diameter as the autologous trachea as a mold, evenly wrap one side of the biological patch layer around the outer periphery of the mold, overlap the excess part with a surgical suture device, and then cut and suture it to obtain an artificial tracheal wall with the same size as the autologous trachea. Figure 3 ).

[0081] (3) After cutting the artificial trachea wall to the corresponding length of the tracheal defect, use non-absorbable sutures to anastomose it with the upper and lower ends of the trachea. Figure 4 ), and after anastomosis, add warm saline to soak, perform ventilator ventilation to eliminate air leakage; then fix the dorsal side of the artificial trachea wall to the anterior wall of the esophagus.

[0082] (4) Take multiple carbon fiber C-shaped external stents, fix them to the outer periphery of the artificial trachea wall with interrupted sutures, wrap around its front wall and left and right walls, and form an external suspension support for the wall. This bionic design of the tracheal cartilage ring can prevent the wall from collapsing due to changes in airway pressure; then take a polyester felt gasket, cut it to the corresponding length to form a wrapping protection for the end of the tracheal external stent to prevent it from bruising the surrounding organs, and obtain a bionic composite artificial trachea ( Figure 5 ).

[0083] (5) Free autologous tissue (which can be omentum, muscle, etc.) is transferred with a pedicle to cover the anastomosis of the bionic composite artificial trachea and the periphery of the trachea wall, wrapping it and providing peripheral blood supply to promote rapid healing of the anastomosis and rapid attachment of autologous tissue around the artificial trachea, ensuring the success of artificial trachea transplantation ( Figure 6 ).

[0084] (6) After the above steps are completed, the surgical incision can be sutured and closed, and the overall preparation process of the bionic composite artificial trachea described in Example 1 of the present invention is completed.

[0085] ◆Case information: Patient: male; 57 years old, cough for 1 year, shortness of breath and difficulty breathing for 4 months.

[0086] ◆Current medical history: One year before the operation, the patient developed a sudden onset of cough, mainly dry cough, with occasional blood in the sputum, without any obvious cause.

[0087] Intermittent anti-inflammatory treatment was given at a local hospital. Five months before surgery, he developed dyspnea and a tracheal mass was found on a lung CT scan. No further treatment was given. A bronchoscopic biopsy was performed at a local hospital 1 week before admission. Figure 7 ), the pathological examination reported adenoid cystic carcinoma.

[0088] ◆Tracheal CT: The lesion in the middle of the trachea affects the whole circumference of the trachea. The length of the affected trachea shown in CT is about 7 cm ( Figure 7 ).

[0089] ◆Preoperative diagnosis: tracheal adenoid cystic carcinoma.

[0090] ◆The patient had undergone extended tracheal tumor resection, and the actual removal of the diseased trachea was about 8.6 cm ( Figure 8 ) until the intraoperative rapid pathological examination report negative margin. Then the artificial trachea of ​​the present invention was applied, with a length of about 9 cm ( Figure 9 The patient recovered smoothly after the operation and was discharged. The CT scan after the operation showed that the trachea was unobstructed and there was no metal artifact interference in the CT image ( Figure 10 Bronchoscopy showed that the inner surface of the artificial trachea was relatively smooth ( Figure 11 ).

[0091] Example 2

[0092] A case of repairing the trachea and right main bronchus (4 cm) with a carbon fiber integral external stent combined with an autologous pericardial patch.

[0093] ◆Medical record: Patient: Male, 56 years old, physical examination revealed tracheal tumor for more than 2 months.

[0094] ◆Current medical history: During the physical examination 2 months before the operation, a tumor was found on the right side of the lower trachea, accompanied by a mild dry cough.

[0095] Further bronchoscopic biopsy diagnosed a low-grade neurothecoma. A CT scan one month before surgery showed a neoplasm on the right side of the lower trachea near the bifurcation and at the opening of the right main bronchus, with luminal stenosis. The general condition was good.

[0096] ◆ Contrast-enhanced lung CT: Neoplasms on the right side of the lower trachea near the bifurcation and at the opening of the right main bronchus, with luminal stenosis. Bronchoscopy: Neoplasms on the right side of the lower trachea with luminal stenosis.

[0097] Pathological examination: low-grade schwannoma.

[0098] ◆After tracheal tumor resection, the patient received tracheal reconstruction with autologous pericardial patch combined with whole-body extratracheal stent ( Figures 13-14 ,in Figure 13 The middle arrow points to the autologous pericardium repairing the tracheal defect. Figure 14 (Image of the integrated tracheal stent). Six months after the operation, the patient's lung function has completely returned to normal, and bronchoscopy has confirmed that the inner wall of the artificial trachea has been remodeled and has mucosal coverage ( Figure 15 ).

[0099] The technical advantages of the present invention are: ① The length of tracheal reconstruction meets the requirements for post-resection reconstruction of extra-long tracheal lesions (8.6 cm of diseased trachea is removed and 9 cm of trachea is reconstructed); ② Only one operation is required to solve the problems of tracheal lesion resection and artificial tracheal reconstruction, greatly reducing the patient's surgical trauma, hospitalization time and treatment costs; ③ Since no staged surgery is required, the patient does not need a long preoperative waiting time, thus meeting the needs of emergency tracheal reconstruction surgery; ④ The present invention does not use metal stent materials, does not block X-rays, and no metal artifacts are generated during imaging examinations, so it does not affect the post-operative CT evaluation; ⑤ The length of the artificial trachea is determined during the operation, and its length can be determined after the diseased trachea is removed. Therefore, there will be no length mismatch, reducing the difficulty and risk of the operation.

[0100] The above description of the disclosed embodiments will enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is to be construed in the widest manner consistent with the principles and novel features disclosed herein.

Claims

1. A bionic composite artificial trachea, comprising: Artificial tracheal wall; the artificial tracheal wall comprises a biological patch layer and an absorbable biomaterial layer from the inside out; the biological patch layer is selected from a bovine pericardium patch layer or an autologous pericardium patch layer; the thickness of the biological patch layer is ≤2 mm; the thickness of the biological patch layer is ≤2 mm; A C-shaped skeletal stent designed to mimic tracheal cartilage rings is disposed on the outer side of the artificial trachea wall. The C-shaped skeletal stent forms a C-shaped structure similar to the tracheal cartilage rings, forming a non-full-circumferential stent wrapping, retaining a membranous structure similar to that of the native trachea. The C-shaped skeletal stent avoids stress on the esophagus that could cause damage to the esophagus, while also providing a certain degree of elasticity and buffering effect when pressure inside and outside the airway changes dramatically. A gasket wrapping the edge of the tracheal stent; the gasket is selected from a polyester felt pad, a Teflon patch, a polypropylene patch, an expanded polytetrafluoroethylene patch or a polyester patch; The thickness of the gasket is ≤3mm; The tracheal stent is a plurality of carbon fiber C-shaped external stents sutured in parallel to the outside of the artificial tracheal wall; the width of the carbon fiber C-shaped external stent is 3mm to 12mm and the thickness is ≤4mm; The interval between two adjacent carbon fiber C-shaped outer brackets is 5mm~10mm.

2. The bionic composite artificial trachea according to claim 1, characterized in that: The tracheal stent is a carbon fiber integrated external stent that is biomimetic and wraps around the outside of the artificial tracheal wall, similar to an organ cartilage ring; the biomimetic wrapping is non-full-circumference wrapping.

3. A method for preparing the biomimetic composite artificial trachea according to any one of claims 1 to 2, comprising the following steps: a) An absorbable biomaterial layer is overlaid on a biological patch layer, and one side of the biological patch layer is then evenly wrapped around a mold identical to the native trachea. Based on the required length of the tracheal defect during surgery, the defect is cut and sutured to create an artificial tracheal wall. A biomimetic external tracheal stent, similar to a tracheal cartilage ring, is then positioned on one side of the absorbable biomaterial layer. Finally, a gasket is wrapped around the edge of the tracheal stent to create a biomimetic composite artificial trachea.

4. The preparation method according to claim 3, characterized in that After wrapping the edge of the tracheal stent with the gasket in step a), the method further includes: The obtained bionic composite artificial trachea was covered with free autologous tissue.

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