Composite system for repairing lung leakage and repairing method

Abstract

The invention discloses a compound system for repairing lung leakage and a repairing method, and belongs to the technical field of thoracic surgery postoperative adjuvant therapy, the compound system for repairing lung leakage comprises an absorbable polymer tissue sealing membrane used for adhering to and covering the surface of a lung tissue leakage position; the absorbable regenerated oxidized cellulose hemostatic non-woven fabric covers the absorbable macromolecular tissue sealing film; the absorbable regenerated oxidized cellulose hemostatic non-woven fabric forms a gel block after being completely soaked by autologous peripheral venous blood, and the gel block is used for fixing the absorbable macromolecular tissue sealing membrane and closing lung damaged tissue through physical action; a double-layer composite structure of the absorbable high-molecular tissue sealing film and the absorbable regenerated oxidized cellulose hemostatic non-woven fabric is arranged, and a double-sealing mechanism combining chemical bonding and physical sealing is adopted, so that the sealing reliability and durability are greatly improved, and the chest pressure change caused by respiratory movement can be effectively resisted.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of postoperative adjuvant therapy of thoracic surgery, in particular to a composite system for lung air leak repair and a repair method. BACKGROUND

[0002] Pulmonary surgery, such as lung wedge resection, lung segment resection or lung lobe resection, is a common means for treating early lung cancer, lung metastasis, emphysema and bulla, etc. With the progress of minimally invasive surgical technology and the popularization of the concept of fast-track surgery, thoracic surgery is developing rapidly towards less trauma and faster recovery. However, patients after thoracic surgery still face the risk of postoperative complications, among which postoperative persistent air leak is one of the most common and difficult complications in thoracic surgery. According to clinical literature reports, its incidence can be as high as 10%-26%. Persistent air leak can significantly prolong the postoperative tube time and hospital stay of patients, increase the risk of pain, infection and medical costs, and seriously hinder the implementation of the ERAS process, which is a key clinical problem that thoracic surgeons are committed to solving.

[0003] The main surgical risk factors leading to postoperative persistent air leak include damage and rupture of the visceral pleura. Clinically, to prevent and treat lung air leak, the main technical means traditionally used is suture repair. In addition to mechanical suture, biological materials are also considered for use to assist in sealing, among which the most representative is medical adhesive / sealant, such as fibrin glue. This type of product forms a fibrin clot to seal the wound by simulating the final stage of human blood coagulation. However, the existing fibrin sealant has obvious limitations: first, the mechanical strength of the final clot is limited, and the adhesive performance often fails to reach the level of reliably preventing lung air leak by itself, especially in the dynamic environment of the continuous tension and relaxation of the pleural surface caused by respiratory movement; second, its compliance is poor, and the formed sealing layer is relatively rigid, making it difficult to move synchronously with the flexible lung tissue surface, and it is easy to peel off or produce cracks from the pleural surface during respiratory activity, resulting in sealing failure. In addition, the single-component sealant has limited functions, and usually does not have additional functions such as active hemostasis or antibacterial properties.

[0004] Therefore, we propose a composite system for lung air leak repair and a repair method to solve the problems raised in the above.

[0005] The above information disclosed in this BACKGROUND section is only for the purpose of increasing the understanding of the background of the present application, and therefore, it can include information known by those of ordinary skill in the art. SUMMARY

[0006] The purpose of this invention is to provide a composite system and repair method for repairing lung leaks, in order to solve the problems mentioned in the background art, such as poor sealing reliability, easy recurrence of leaks, and insufficient biocompatibility of single biological sealants currently on the market in fragile lung tissue.

[0007] To achieve the above objectives, the present invention provides a composite system for repairing air leaks in the lungs, comprising:

[0008] Absorbable polymer tissue sealing film is used to adhere and cover the surface of air leaks in lung tissue.

[0009] An absorbable regenerated oxidized cellulose hemostatic nonwoven fabric is placed over the absorbable polymer tissue sealing membrane.

[0010] The absorbable regenerated oxidized cellulose hemostatic nonwoven fabric forms a gel block after being completely soaked in autologous peripheral venous blood. The gel block is used to fix the absorbable polymer tissue sealing membrane and close the damaged lung tissue through physical action.

[0011] The absorbable polymer tissue sealing membrane has a three-layer composite structure. The innermost and outermost layers are both poly(lactide-co-glycolic acid), which serves as both the internal adhesive matrix and the anti-adhesion layer. The middle layer is poly(N-vinylpyrrolidone). 50 -Co-N-hydroxysuccinimide acrylate 25 The poly(N-vinylpyrrolidone) 50 -Co-N-hydroxysuccinimide acrylate 25 It adheres to the surface of lung tissue through ionic and covalent bonds, forming an isolation membrane to prevent leakage;

[0012] The composite system has the effect of killing Gram-positive and Gram-negative microorganisms, including aerobic and anaerobic bacteria.

[0013] Furthermore, the amount of autologous peripheral venous blood used is 10 ml.

[0014] The repair method for repairing air leaks in the lungs includes the following steps:

[0015] The presence of air leakage was confirmed by immersion testing. The absorbable polymer tissue sealing membrane was then adhered to the surface of the air leakage site. The absorbable regenerated oxidized cellulose hemostatic nonwoven fabric was then placed on top of the absorbable polymer tissue sealing membrane. 10 ml of the patient's own peripheral venous blood was injected onto the absorbable regenerated oxidized cellulose hemostatic nonwoven fabric, and the nonwoven fabric was allowed to absorb the blood and form a gel, thus completing the air leakage repair.

[0016] Compared with the prior art, the beneficial effects of the present invention are:

[0017] This invention employs a double-layer composite structure consisting of an absorbable polymer tissue sealing membrane and an absorbable regenerated oxidized cellulose hemostatic nonwoven fabric. The sealing membrane achieves tight adhesion to the tissue surface through ionic and covalent bonds, providing a first layer of chemical sealing. The nonwoven fabric above it, after being soaked in autologous blood, forms a robust gel, constituting a second physical barrier. This dual sealing mechanism, combining chemical adhesion and physical sealing, significantly improves the reliability and durability of the seal, effectively resisting changes in intrathoracic pressure caused by respiratory movements.

[0018] The polylactide and regenerated oxidized cellulose used in this invention are both clinically proven bioabsorbable materials. After initially functioning, they can be gradually degraded and absorbed in the body through hydrolysis and other pathways, eliminating the need for secondary surgery. Furthermore, the use of the patient's own peripheral blood completely avoids the risks of immune rejection and disease transmission that may arise from the use of allogeneic or foreign biological agents, ensuring extremely high safety.

[0019] The absorbable regenerated oxidized cellulose material possesses broad-spectrum antibacterial properties, effectively killing a variety of Gram-positive and Gram-negative bacteria. While providing a seal to the wound, it also creates a sterile environment locally, fundamentally reducing the risk of postoperative infection, a common complication, and creating favorable conditions for tissue healing.

[0020] The composite system in this invention eliminates the need for complex suturing techniques, making it particularly suitable for minimally invasive surgeries such as thoracoscopic surgery where operating space is limited, lung tissue is fragile, or there are irregular wounds near the hilum or other areas where traditional suturing methods are difficult to implement. The entire procedure is simple, requiring only three steps: application, covering, and blood injection, thus shortening surgical time and improving surgical efficiency.

[0021] The above overview is for illustrative purposes only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features of the invention will become readily apparent from the accompanying drawings and the following detailed description. Attached Figure Description

[0022] Figure 1 This is a system diagram of the composite system of the present invention. Detailed Implementation

[0023] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. It should be noted that the drawings are schematic and not illustrated to scale. For clarity and convenience, the relative sizes and proportions of the parts shown in the drawings have been exaggerated or reduced in size. Any size is only illustrative and not limiting.

[0024] Example 1: A composite system for repairing air leaks in the lungs, comprising:

[0025] Absorbable polymer tissue sealing film is used to adhere and cover the surface of air leaks in lung tissue.

[0026] An absorbable regenerated oxidized cellulose hemostatic nonwoven fabric is placed over the absorbable polymer tissue sealing membrane.

[0027] The absorbable regenerated oxidized cellulose hemostatic nonwoven fabric forms a gel block after being completely soaked in autologous peripheral venous blood. The gel block is used to fix the absorbable polymer tissue sealing membrane and seal the damaged lung tissue through physical action. The amount of autologous peripheral venous blood used is 10 ml.

[0028] The absorbable polymer tissue sealing membrane has a three-layer composite structure. The innermost and outermost layers are both poly(lactide-co-glycolic acid), which serves as both the internal adhesive matrix and the anti-adhesion layer. The middle layer is poly(N-vinylpyrrolidone). 50 -Co-N-hydroxysuccinimide acrylate 25 The poly(N-vinylpyrrolidone) 50 -Co-N-hydroxysuccinimide acrylate 25 It can adhere to the surface of lung tissue through ionic and covalent bonds, forming an isolation membrane to prevent leakage;

[0029] The system has the function of killing Gram-positive and Gram-negative microorganisms, including aerobic and anaerobic bacteria.

[0030] Example 2: A repair method for repairing air leaks in the lungs, comprising the following steps:

[0031] The presence of air leakage was confirmed by immersion testing. The absorbable polymer tissue sealing membrane was then adhered to the surface of the air leakage site. The absorbable regenerated oxidized cellulose hemostatic nonwoven fabric was then placed on top of the absorbable polymer tissue sealing membrane. 10 ml of the patient's own peripheral venous blood was injected onto the absorbable regenerated oxidized cellulose hemostatic nonwoven fabric, and the nonwoven fabric was allowed to absorb the blood and form a gel, thus completing the air leakage repair.

[0032] Example 3: Preparation of a composite system for repairing lung leaks

[0033] Preparation of absorbable polymer tissue sealing membrane:

[0034] A certain amount of poly(lactide co-glycolic acid) is dissolved in an organic solvent to form a 10% (w / v) solution A.

[0035] Take a certain amount of poly(N-vinylpyrrolidone) 50 -Co-N-hydroxysuccinimide acrylate 25 It dissolves in deionized water to form a 15% (w / v) solution B.

[0036] A three-layer composite film was prepared using a layer-by-layer casting coating method: First, a layer of solution A was cast onto a mold and dried at 40°C to form the first layer (anti-blocking layer); then, a layer of solution B was cast onto its surface and dried to form the second layer (active isolation layer); finally, another layer of solution A was cast and dried to form the third layer (outermost anti-blocking layer). The final composite film had a thickness of 100±20 μm, was cut to the required size, sterilized by cobalt-60 irradiation, and prepared for use.

[0037] Prepare absorbable regenerated oxidized cellulose hemostatic nonwoven fabric: Purchase commercially available regenerated oxidized cellulose nonwoven fabric, cut it to a size that matches or is slightly larger than the above-mentioned sealing film, sterilize it using conventional ethylene oxide gas, and set it aside for later use.

[0038] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A composite system for lung air leak repair, characterized in that, It comprises: an absorbable high-molecular tissue sealing film, which is adhered to the surface of a lung tissue air leak; an absorbable regenerated oxidized cellulose hemostatic nonwoven fabric, which is covered on the absorbable high-molecular tissue sealing film; the absorbable regenerated oxidized cellulose hemostatic nonwoven fabric forms a gel block after being fully soaked with autologous peripheral venous blood, the gel block is used to fix the absorbable high-molecular tissue sealing film and to close the lung damaged tissue by physical effect; The absorbable high-molecular tissue sealing film is a three-layer composite structure, the innermost layer and the outermost layer are both poly(lactide-co-glycolide), which simultaneously serves as the inner adhesive matrix and the anti-adhesion layer; the middle layer is poly(N-vinyl-pyrrolidone 50 -co-N-hydroxysuccinimidyl acrylate 25 ), which is adhered to the surface of the lung tissue through ionic bonds and covalent bonds to form an isolation film to prevent leakage; 50 -co-N-hydroxysuccinimidyl acrylate 25 ) through ionic bonds and covalent bonds to form an isolation film to prevent leakage; the composite system has the effect of killing gram-positive and gram-negative microorganisms, including aerobic and anaerobic bacteria.

2. A composite system for lung air leak repair according to claim 1, characterized in that: The amount of autologous peripheral venous blood is 10 ml.

3. The method of repair for lung air leaks according to any one of claims 1-2, wherein, It comprises the following steps: a lung air leak is confirmed by evaluating the lung air leak through a submerged test method; the absorbable high-molecular tissue sealing film is adhered to the surface of the lung air leak; the absorbable regenerated oxidized cellulose hemostatic nonwoven fabric is covered on the absorbable high-molecular tissue sealing film; 10 ml of autologous peripheral venous blood of the patient is injected above the absorbable regenerated oxidized cellulose hemostatic nonwoven fabric, and the nonwoven fabric is saturated with blood to form a gel block, thereby completing the repair of the lung air leak.

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