Device for correcting softened narrow super-long trachea

Through the C-type external tracheal stent and robotic minimally invasive approach technology braided by NiTi memory alloy, surgical limitations and internal stent complications in the treatment of ultra-long tracheal softening and stenosis are solved, and effective support and functional recovery of the trachea are achieved.

CN120022114APending Publication Date: 2025-05-23HARBIN MEDICAL UNIVERSITY
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Patent Information

Application Number
CN202510013329.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-06
Publication Date
2025-05-23

AI Technical Summary

Technical Problem

The prior art has limitations in the treatment of ultra-long tracheal softening stenosis. Long-term use of endotracheal stents often accompanied by complications, such as stent displacement and restenosis.

Method used

A C-type tracheal outer bracket woven from nickel-titanium memory alloy wire was designed, which was fixed to the cartilage side of the tracheal through robotic minimally invasive access technology, and the shape memory function of nickel-titanium memory alloy is used to accurately adapt and support the tracheal.

Benefits of technology

This method significantly improves the patient's symptoms, avoids the complications of traditional endotracheal stent placement, and provides a more ideal way to treat ultra-long non-neoplastic tracheal stenosis.

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Abstract

The invention belongs to the technical field of correction of ultra-long tracheal softening stenosis, and particularly relates to a device for correcting ultra-long tracheal softening stenosis, which comprises an outer tracheal stent, the outer tracheal stent is formed by weaving nickel-titanium memory alloy metal wires, the diameter of the metal wires is 0.26 mm, the metal wires are woven into a rectangular structure, the width of the rectangular structure is 1cm, and the diameter of each mesh is 1.8 * 1.8 mm. The outer tracheal stent is woven by nickel-titanium memory alloy metal wires and shaped into a C-shaped structure with a 240-degree open ring, the diameter of the outer tracheal stent is 2.6 cm, and the outer tracheal stent is designed to adapt to and support an ultra-long trachea which is softened or collapsed and deformed. The precise matching with the trachea of the patient is realized. The customized design ensures that the stent can be tightly attached to and effectively support the softened or collapsed trachea, so that the mechanical stability and air tightness of the stent are recovered, and the problem of displacement or restenosis possibly existing in a traditional stent is solved.
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Description

Technical Field

[0001] The invention belongs to the technical field of correcting super-long tracheal softening and stenosis, and in particular relates to a device for correcting super-long tracheal softening and stenosis. Background Art

[0002] Tracheal stenosis is a serious respiratory disease. Its common causes include endotracheal tuberculosis, endotracheal intubation and other benign diseases. These lesions often lead to tracheal wall softening and collapse, which in turn causes limited respiratory function. Symptoms include shortness of breath, cough, sputum, wheezing, gasping and recurrent respiratory tract infections, which can be life-threatening in severe cases.

[0003] Currently, there are various treatments for tracheal stenosis, among which surgical resection and reconstruction are recognized as the best means to treat tracheal stenosis. However, tracheal resection and reconstruction have limitations, especially when the length of the diseased trachea exceeds a certain limit (>50% or 6cm in adults and >30% in children), direct end-to-end anastomosis may fail due to excessive anastomotic tension, limiting the scope of application of this surgical method.

[0004] In cases where direct surgical resection and reconstruction are not possible, endotracheal stent placement has become a widely used alternative treatment option. Although endotracheal stents can quickly restore airway patency, their long-term use is often accompanied by a variety of complications, such as stent migration and restenosis caused by granulation tissue hyperplasia, which seriously affect the patient's prognosis and quality of life.

[0005] In order to overcome the limitations of endotracheal stent placement, extratracheal stent fixation has gradually attracted attention as an emerging treatment method. This procedure fixes the stent to the outside of the trachea to support the softened or collapsed trachea without changing the mucociliary structure of the airway, thereby reducing the occurrence of complications such as airway obstruction. At present, external stent materials include polypropylene mesh (Marlex), polytetrafluoroethylene (PTFE), 3D printed bioresorbable materials, etc., but these materials still have some problems in practical applications, such as fixed-size stents may restrict tracheal growth and absorbable stents may degenerate prematurely. Summary of the invention

[0006] The purpose of the present invention is to provide a device for correcting ultra-long tracheal softening and stenosis, and to design and manufacture a C-type tracheal stent by utilizing the excellent properties of nickel-titanium memory alloy. Nickel-titanium memory alloy has good biocompatibility and shape memory function, and can accurately adapt to and support softened or collapsed trachea. Through robotic minimally invasive approach technology, we successfully fixed this C-type tracheal stent to the tracheal cartilage side, restoring the original structure and function of the airway. This treatment method not only significantly improves the patient's symptoms, but also avoids the various complications of traditional endotracheal stent placement, providing a more ideal treatment method for adults with longer non-tumor tracheal stenosis that cannot be surgically removed and reconstructed.

[0007] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: a device for correcting the softening and stenosis of an extra-long trachea, comprising an extra-tracheal stent, wherein the extra-tracheal stent is woven from nickel-titanium memory alloy wires, wherein the wires have a diameter of 0.26 mm and are woven into a rectangular structure with a width of 1 cm and a mesh diameter of 1.8 x 1.8 mm for each mesh, and are shaped into a C-shaped structure with an open ring of 240°. The diameter of the extra-tracheal stent is 2.6 cm, and is designed to adapt to and support softened or collapsed and deformed extra-long trachea.

[0008] Preferably, a Dacron heart patch material is also included to completely separate the trachea from the surrounding blood vessels to reduce postoperative adhesions and complications.

[0009] Preferably, the size and shape of the nickel-titanium memory alloy extratracheal stent are customized according to the patient's tracheal three-dimensional imaging data to ensure accurate matching and effective support between the stent and the trachea.

[0010] Preferably, the extratracheal stent penetrates the tracheal cartilage through a non-absorbable suture and is firmly fixed to the side of the tracheal cartilage to restore the mechanical stability and airtightness of the trachea.

[0011] Preferably, the method further comprises the following steps:

[0012] 1) Assess tracheal stenosis through tracheal three-dimensional imaging and bronchoscopy;

[0013] 2) Using a robotic minimally invasive approach, the anterior surface of the trachea is freed to expose the tracheal cartilage, but the blood supply to the membranous side is preserved;

[0014] 3) fixing the extratracheal stents one by one on the tracheal cartilage side at predetermined intervals;

[0015] 4) Use polyester heart patch material to completely separate the trachea from the surrounding blood vessels;

[0016] 5) After the operation, bronchoscopy is performed to confirm that the tracheal morphology has returned to normal and to monitor postoperative recovery.

[0017] Preferably, when freeing the front surface of the trachea, precise operation of the robot lens arm and the auxiliary arm is utilized to avoid damage to the tracheal membranous part while maintaining a clear surgical field of view.

[0018] Preferably, when placing the extratracheal stent, the position of the patient's head and the endotracheal tube are adjusted to avoid the puncture of the balloon of the endotracheal tube by the suture needle, thereby ensuring the safety of the operation.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] 1: The tracheal stent of the present invention is woven with nickel-titanium memory alloy wire, and achieves precise matching with the patient's trachea by precisely controlling the diameter of the wire, the braiding structure, and the diameter and shape of the stent. This customized design ensures that the stent can fit tightly and effectively support the softened or collapsed trachea, thereby restoring its mechanical stability and airtightness, and avoiding the displacement or restenosis problems that may exist in traditional stents.

[0021] 2: During the operation, the present invention introduces polyester heart repair material as an isolation layer to completely separate the trachea from the surrounding blood vessels. This innovative measure effectively reduces the occurrence of postoperative adhesions, reduces the risk of complications, and improves the safety of the operation and the patient's postoperative quality of life.

[0022] 3: The present invention uses a minimally invasive robotic approach to perform surgery, and uses the precise control of the robotic lens arm and auxiliary arm to achieve fine mobilization of the anterior surface of the trachea while retaining the blood supply on the membranous side. In this process, the stability and precision of the robotic surgery greatly reduced damage to the membranous part of the trachea, maintained a clear surgical field of view, and ensured the safety of the surgery.

[0023] 4: When placing the extratracheal stent, the present invention avoids potential risks such as the suture needle piercing the balloon of the tracheal tube by adjusting the position of the patient's head and the position of the tracheal tube, thereby ensuring the safety of the operation. After the operation, the patient's tracheal morphology quickly returns to normal, and due to the excellent performance of the stent material, its support effect is long-lasting and stable, which is conducive to the patient's long-term recovery. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a schematic diagram of the external support of the present invention;

[0025] Figure 2 This is a product diagram of the external support of the present invention. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] Please refer to the attached Figure 1-2 , several embodiments provided by the present invention:

[0028] A device for correcting softening and stenosis of an extra-long trachea, comprising an extra-tracheal stent, the extra-tracheal stent being woven from nickel-titanium memory alloy wires, the wires having a diameter of 0.26 mm, woven into a rectangular structure with a width of 1 cm and a mesh diameter of 1.8 x 1.8 mm for each mesh, and shaped into a C-shaped structure with an open ring of 240°, the extra-tracheal stent having a diameter of 2.6 cm, and being designed to adapt to and support softened or collapsed and deformed extra-long trachea.

[0029] Furthermore, it also includes a polyester heart patch material for completely separating the trachea from the surrounding blood vessels to reduce postoperative adhesions and complications.

[0030] Furthermore, the size and shape of the nickel-titanium memory alloy extratracheal stent is customized according to the patient's tracheal three-dimensional imaging data to ensure the precise match and effective support of the stent and trachea. The personalized design avoids the problems of inappropriate size or insufficient support that may exist in traditional stents, thereby improving the surgical effect.

[0031] Furthermore, the extratracheal stent penetrates the tracheal cartilage through non-absorbable sutures and is firmly fixed to the side of the tracheal cartilage to restore the mechanical stability and airtightness of the trachea. The fixation of the extratracheal stent not only provides immediate support for the trachea, but also helps promote the healing of the tracheal cartilage and surrounding tissues. With the support of the stent, the tracheal cartilage can gradually restore its original structure and function, while the surrounding tissues can also be better repaired and regenerated.

[0032] Furthermore, the following steps are included:

[0033] 1) Assess tracheal stenosis through tracheal three-dimensional imaging and bronchoscopy;

[0034] 2) Using a robotic minimally invasive approach, the anterior surface of the trachea is freed to expose the tracheal cartilage, but the blood supply to the membranous side is preserved;

[0035] 3) Fixing the extratracheal stents one by one on the tracheal cartilage side at predetermined intervals;

[0036] 4) Use polyester heart patch material to completely separate the trachea from the surrounding blood vessels;

[0037] 5) After the operation, bronchoscopy is performed to confirm that the tracheal morphology has returned to normal and to monitor postoperative recovery.

[0038] Furthermore, when the front surface of the trachea is freed, the precise operation of the robot lens arm and the auxiliary arm can be used to avoid damage to the tracheal membrane while maintaining a clear surgical field of view. The precise operation of the robot lens arm and the auxiliary arm can achieve high-precision surgical operations in complex anatomical environments, such as avoiding damage to the tracheal membrane when the front surface of the trachea is freed and maintaining a clear surgical field of view. This high-precision operation not only improves the success rate of the operation, but also greatly reduces the risk of the operation.

[0039] Furthermore, when placing the extratracheal stent, the position of the patient's head and the endotracheal tube is adjusted to avoid the suture needle puncturing the balloon of the endotracheal tube, thereby ensuring the safety of the operation. This preventive measure greatly reduces the risk during the operation, protects the patient's airway safety, and avoids serious consequences that may be caused by balloon rupture, such as gas leakage and airway obstruction.

[0040] It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above and that the invention can be implemented in other specific forms without departing from the spirit or essential features of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations falling within the meaning and scope of the equivalent elements of the claims be included in the invention. Any reference numeral in a claim should not be considered as limiting the claim to which it relates.

Claims

1. A device for correcting tracheal softening and stenosis, characterized in that: It includes an extratracheal stent, which is woven from nickel-titanium memory alloy wires. The wires have a diameter of 0.26 mm and are woven into a rectangular structure with a width of 1 cm and a mesh diameter of 1.8 x 1.8 mm for each mesh. The structure is shaped into a C-shaped structure with an open ring of 240°. The diameter of the extratracheal stent is 2.6 cm, and it is designed to adapt to and support softened or collapsed and deformed extra-long trachea.

2. A device for correcting ultra-long tracheal softening and stenosis according to claim 1, characterized in that: Also included is a Dacron heart patch material that is used to completely separate the trachea from surrounding blood vessels to reduce postoperative adhesions and complications.

3. The device for correcting ultra-long tracheal softening and stenosis according to claim 1, characterized in that: The size and shape of the nickel-titanium memory alloy extratracheal stent are customized according to the patient's tracheal three-dimensional imaging data to ensure accurate matching and effective support between the stent and the trachea.

4. The device for correcting ultra-long tracheomalacia and stenosis according to claim 1, characterized in that: The tracheal external stent penetrates the tracheal cartilage through a non-absorbable thread and is firmly fixed to the side of the tracheal cartilage to restore the mechanical stability and air tightness of the trachea.

5. A device for correcting tracheal softening and stenosis, characterized in that: The following usage steps are also included: 1) Assess tracheal stenosis through tracheal three-dimensional imaging and bronchoscopy; 2) Using a robotic minimally invasive approach, the anterior surface of the trachea is freed to expose the tracheal cartilage, but the blood supply to the membranous side is preserved; 3) fixing the extratracheal stents one by one on the tracheal cartilage side at predetermined intervals; 4) Use polyester heart patch material to completely separate the trachea from the surrounding blood vessels; 5) After the operation, bronchoscopy is performed to confirm that the tracheal morphology has returned to normal and to monitor postoperative recovery.

6. The device for correcting ultra-long tracheomalacia and stenosis according to claim 5, characterized in that: When freeing the front surface of the trachea, precise operation of the robot lens arm and the auxiliary arm is utilized to avoid damage to the tracheal membrane while maintaining a clear surgical field of view.

7. The device for correcting ultra-long tracheomalacia and stenosis according to claim 5, characterized in that: When placing the extratracheal stent, the position of the patient's head and the position of the endotracheal tube are adjusted to avoid the suture needle from puncturing the balloon of the endotracheal tube, thereby ensuring safe operation.