Controlled-release drug-loading airway stent
By designing the combined structure of the endometrium, naked bracket body, isolation membrane, pharmaceutical membrane, and exterior membrane in the airway bracket, the existing airway stent drugs are unstable and the long -term use of metal brackets brought by the tracheal injury The problem realizes the slowness, continuous release and effective support of the drug.
Patent Information
- Application Number
- CN202322998820.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2023-11-07
- Publication Date
- 2025-01-28
- Estimated Expiration
- 2033-11-07
AI Technical Summary
Existing airway stents have sudden and instability in drug release, resulting in poor treatment effects, and metal stents may cause tracheal damage and restenosis after long-term use.
Designed a controllable release of the patent gascut bracket, including endometrium, naked bracket main body, isolation membrane, pharmaceutical membrane, and exterior membrane. Through the combination of these levels Support to keep the airway unobstructed.
The safety and effective release of drugs have been achieved, the duration of the treatment effect is extended, and the tracheal damage and re -narrowing problems brought by the long -term use of metal brackets are avoided.
Smart Images
Figure CN222398944U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical devices, and more specifically, to a controlled-release drug-loaded airway stent. Background Art
[0002] Tracheal stenosis mainly refers to the stenosis of the main trachea, bronchi, lobar bronchi and segmental bronchi. The main causes are congenital or caused by infection, primary or secondary malignant tumors or hyperplasia in the trachea, trauma, endobronchial tuberculosis and other diseases. Traditional radiotherapy or chemotherapy cannot directly relieve tracheal stenosis immediately. Exogenous radiotherapy or intraluminal radiotherapy requires sufficient time to take effect, so it is generally not used as the best treatment for tracheal stenosis. In recent years, the technology of endotracheal stent placement has continued to mature. After the placement of tracheal stents, patients with tracheal stenosis can quickly relieve dyspnea, improve clinical symptoms, and improve quality of life, with significant short-term effects.
[0003] At present, the tracheal stents on the market mainly include non-metallic stents and metal stents. Non-metallic stents mainly refer to silicone tubular stents, which have the advantages of soft material, good tissue compatibility, and little stimulation to the airway mucosa. However, silicone stents have little friction with the tube wall, and are prone to complications such as stent displacement and falling off. Metal stents have the advantages of strong support, good spatial structure, and stents that are not easy to shift. The metal stents currently used in clinical practice are mostly made of nickel-titanium alloy materials. Further, metal stents can be divided into bare metal stents and drug-eluting metal stents. Bare metal stents have little effect on the normal function of cilia in the trachea and are not easy to affect the discharge of mucus, but fatigue after the bare metal stent is implanted will cause the stent itself to break, damage the tracheal mucosa, cause abnormal or excessive proliferation of fibrous tissue, cause restenosis in the stent, and even cause tracheal perforation. Drug-eluting stents have obvious advantages over bare stents: they can not only block fistulas, but also inhibit or prevent tumors or hyperplastic tissues and granulation tissues from bulging into the tracheal cavity to cause tracheal stenosis.
[0004] The airway stents currently prepared have the following problems: (1) Stents without coatings are prone to displacement and cause secondary blockage; (2) Stents with coatings but no drug loading only physically prevent tumors or hyperplastic tissue from growing into the stent lumen, but cannot actively treat the lesion site, inhibit the growth of tumors or hyperplasia, or play a therapeutic role in shrinking tumors or hyperplasia; (3) Drug-coated stents: drug release is too fast, with a significant burst release in the early stage, and the drug is concentrated in the first 1 to 3 days, resulting in no therapeutic effect in the later stage; there is no outer membrane protection on the outside of the stent drug film, and body fluids will have a washing effect on the exposed drug film, causing the drug to be lost and failing to achieve a targeted therapeutic effect.
[0005] Therefore, it is necessary to solve the above technical problems. Utility Model Content
[0006] In view of this, the purpose of the utility model is to propose a controlled-release drug-loaded airway stent to reconstruct the narrowed section of the airway, play a physical support role, maintain unobstructed breathing, and continuously and slowly release the drug after implantation, thereby achieving the purpose of safe and effective treatment.
[0007] Based on the above purpose, the utility model provides a controlled-release drug-loaded airway stent, comprising an inner membrane, a bare stent body, an isolation membrane, a drug-loaded membrane and a controlled-release outer membrane arranged in sequence from the inside to the outside, the inner membrane is coated on the inner side of the bare stent body, and the isolation membrane, the drug-loaded membrane and the controlled-release outer membrane are sprayed on the outer side of the bare stent body in sequence; or, comprising a bare stent body, an inner membrane, an isolation membrane, a drug-loaded membrane and a controlled-release outer membrane arranged in sequence from the inside to the outside.
[0008] Optionally, the bare stent body is a porous mesh structure of nickel-titanium alloy, the inner diameter of the bare stent body is 8 to 24 mm, the length of the bare stent body is 10 to 80 mm, and the wire diameter of the porous mesh structure is 0.10 to 0.32 mm.
[0009] Optionally, the inner diameter of the bare stent body is 14 to 22 mm.
[0010] Optionally, the length of the bare stent body is 20 to 60 mm.
[0011] Optionally, the wire diameter of the porous mesh structure is 0.18-0.30 mm.
[0012] Optionally, the coating length of the bare stent body is 60 to 80%.
[0013] Optionally, the inner mold is made of medical silicone rubber material.
[0014] Optionally, the isolation membrane is made of medical polyurethane material.
[0015] Optionally, a primer is coated between the inner film and the isolation film.
[0016] Optionally, the drug-loaded membrane is composed of drug active molecules, medical polyurethane materials and penetration enhancers.
[0017] Optionally, the outer film is made of medical polyurethane material.
[0018] The controlled-release drug-loaded airway stent provided by the utility model comprises an inner membrane, a bare stent body, an isolation membrane, a drug-loaded membrane and a controlled-release outer membrane arranged in sequence from the inside to the outside, by coating the inner membrane on the inner side of the bare stent body, and spraying the isolation membrane, the drug-loaded membrane and the controlled-release outer membrane on the outer side of the bare stent body in sequence, or comprising a bare stent body, an inner membrane, an isolation membrane, a drug-loaded membrane and a controlled-release outer membrane arranged in sequence from the inside to the outside. The controlled-release drug-loaded airway stent provided by the utility model reconstructs the airway of the narrow section, plays a role of physical support, keeps breathing unobstructed, and can continuously and slowly release the drug after implantation, thereby achieving the purpose of safe and effective treatment. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings, which will help to understand the purpose and advantages of the present invention, wherein:
[0020] Figure 1 This is a schematic structural diagram of a controlled-release drug-loaded airway stent according to an embodiment of the utility model;
[0021] Figure 2 A cross-sectional view of a controlled-release drug-loaded airway stent according to an embodiment of the utility model;
[0022] Figure 3 This is a cross-sectional view of a controlled-release drug-loaded airway stent according to another embodiment of the utility model.
[0023] Description of reference numerals:
[0024] 1: bare stent body; 2: inner membrane; 3: isolation membrane; 4: drug-loaded membrane; 5: controlled-release outer membrane. DETAILED DESCRIPTION
[0025] The present invention is described in detail below in conjunction with the embodiments. The same components are denoted by the same reference numerals. It should be noted that the words "front", "rear", "left", "right", "upper" and "lower" used in the following description refer to directions in the drawings, and the words "inner" and "outer" refer to directions toward or away from the geometric center of a specific component, respectively.
[0026] like Figure 1 As shown, the controlled-release drug-loaded airway stent provided by the utility model comprises an inner membrane 2, a bare stent body 1, an isolation membrane 3, a drug-loaded membrane 4 and a controlled-release outer membrane 5 which are arranged in sequence from the inside to the outside, the inner membrane 2 is coated on the inner side of the bare stent body 1, and the isolation membrane 3, the drug-loaded membrane 4 and the controlled-release outer membrane 5 are sprayed on the outer side of the bare stent body 1 in sequence; or, comprises a bare stent body 1, an inner membrane 2, an isolation membrane 3, a drug-loaded membrane 4 and a controlled-release outer membrane 5 which are arranged in sequence from the inside to the outside.
[0027] The controlled-release drug-loaded airway stent provided by the utility model comprises an inner membrane 2, a bare stent body 1, an isolation membrane 3, a drug-loaded membrane 4 and a controlled-release outer membrane 5 which are sequentially arranged from the inside to the outside, by coating the inner membrane 2 on the inner side of the bare stent body 1, and spraying the isolation membrane 3, the drug-loaded membrane 4 and the controlled-release outer membrane 5 on the outer side of the bare stent body 1 in sequence, or, comprises a bare stent body 1, an inner membrane 2, an isolation membrane 3, a drug-loaded membrane 4 and a controlled-release outer membrane 5 which are sequentially arranged from the inside to the outside. The controlled-release drug-loaded airway stent provided by the utility model reconstructs the airway of the narrow section, plays a role of physical support, keeps breathing unobstructed, and can continuously and slowly release the drug after implantation, thereby achieving the purpose of safe and effective treatment.
[0028] like Figure 1 As shown, the bare stent body 1 is a porous mesh structure of nickel-titanium alloy, the inner diameter of the bare stent body 1 is 8 to 24 mm, the length of the bare stent body 1 is 10 to 80 mm, and the wire diameter of the porous mesh structure is 0.10 to 0.32 mm. In this embodiment, the nickel-titanium alloy used in the bare stent body 1 has a unique and perfect shape memory function and superelastic performance, good flexibility and plasticity, large expansion force, support force and wear resistance and corrosion resistance, and good biocompatibility. In the human body (ambient temperature is greater than 33°C), the bare stent body 1 is released from the implanter and can immediately return to its original shape, generating a continuous and gentle radial expansion force, acting on the inner wall of the trachea, so that the narrow part expands and restores patency. The bare stent body 1 with a porous mesh structure of nickel-titanium alloy in the above numerical range plays a better role in physical support and improves the safety of the use of the controlled release drug-loaded airway stent.
[0029] In one embodiment of the utility model, the inner diameter of the bare stent body 1 is 14 to 22 mm. In this embodiment, the inner diameter in the above numerical range is designed based on the size of the human trachea, so that the bare stent body 1 can better adhere to the trachea, provide sufficient support for the stenosis of the trachea, and prevent displacement, thereby improving the safety of the controlled-release drug-loaded airway stent.
[0030] In one embodiment of the utility model, the length of the bare stent body 1 is 20 to 60 mm. The bare stent body 1 in the above numerical range can better adapt to the size of common clinical tumors, so that the controlled-release drug-loaded airway stent can better reconstruct the narrowed section of the airway without causing discomfort to the patient.
[0031] In one embodiment of the utility model, the wire diameter of the porous mesh structure is 0.18-0.30 mm. The bare stent body 1 within the above numerical range can provide physical support to the narrow trachea segment while better maintaining the flexibility of the controlled-release drug-loaded airway stent.
[0032] In one embodiment of the utility model, the coating length of the bare stent body 1 is 60-80%, and the coating length can be 100%. The coating length in the above numerical range can not only ensure that the lesion position of the tracheal stenosis segment is covered, but also avoid the problem of difficulty in mucus discharge and mucus retention caused by excessive coating of the controlled-release drug-eluting airway stent.
[0033] In one embodiment of the utility model, the inner mold is made of medical silicone rubber material. Medical silicone rubber material has excellent physical properties such as elongation at break ≥ 400%, tensile strength 5-30N / mm 2 , because the inner membrane 2 has good adhesion and tensile properties on the bare stent body 1, the bare stent body 1 can expand to its original state after implantation, reducing the risk of displacement. The inner membrane 2 has a tight membrane structure that can effectively prevent the growth of airway hyperplasia tissue toward the inner wall of the stent, improving the safety of the controlled release drug-loaded airway stent and achieving the purpose of effective treatment. Specifically, the coating process of the inner membrane 2 should try to adopt an integrated film-forming method, the coating process of the inner membrane 2 can be dip coating, the coating process of the inner membrane 2 can also be solution film laying, and then the film is bonded to the inner wall of the bare stent body 1 by thermal fusion, etc.; in order to make the inner membrane 2 have the function of blocking the drug from penetrating the inner side of the bare stent body 1, and at the same time prevent the growth of airway hyperplasia tissue / granulation into the stent lumen, the inner membrane 2 is required to have a certain thickness, but it should not affect the free stretching of the stent and the function of loading and pushing out the stent conveyor. The appropriate thickness of the inner membrane 2 needs to be controlled at 60-100um.
[0034] In one embodiment of the utility model, the isolation film 3 is a medical polyurethane material. The isolation film 3 serves as a bridge for bonding the inner film 2 and the drug-loaded film 4. The bending modulus of the medical polyurethane material is 5000-8000 N / m 2 , tensile strength 400~600N / mm 2 The material has excellent elongation at break, elongation ≥ 325%, moderate molecular weight, molecular chain length and arrangement state determine that its film structure has a suitable environment for drug release and dissolution, and the material has good solvent resistance and biological stability; specifically, the film coating method of the isolation membrane 3 can be ultrasonic spraying, or can be coated by dipping, electrostatic spraying, etc. In order not to affect the free stretching of the bare stent body 1 and the function of loading and pushing out the bare stent body 1 conveyor, and at the same time play the role of a bridge connecting the drug-loaded film 4 and the inner membrane 2, the isolation membrane 3 should be as thin as possible on the basis of being able to form a film, and the appropriate thickness of the isolation membrane 3 should be controlled at 5 to 30 um.
[0035] In one embodiment of the utility model, a primer is coated between the inner membrane 2 and the isolation membrane 3. The primer increases the contact area and enhances the adhesive force, thereby improving the structural stability of the controlled-release drug-loaded airway stent.
[0036] In one embodiment of the utility model, the drug-loaded film 4 is composed of active drug molecules, medical polyurethane materials and penetration enhancers. The drug-loaded film 4 is mainly used to load drugs onto the bare stent body 1, so that the drugs are firmly attached to the bare stent body 1, and control the release rate of the drugs, play the role of carrying drug molecules and controlling the uniform release of drug molecules. On the basis of ensuring that the drug loading amount meets the treatment requirements and that the drug release cycle reaches the expected design effect, the thickness of the drug-loaded film 4 is controlled between 50 and 80 um.
[0037] In one embodiment of the utility model, the outer membrane is a medical polyurethane material. The outer membrane of the polyurethane material has moderate softness, and the tensile performance meets the requirements. Combined with the process characteristics, the structure of the film material is neither too tight nor too loose, and at the same time forms the characteristics of layer-by-layer stacking film, so that the drug penetrates the layers of the outer membrane during the release process and finally permeates out, effectively avoiding the sudden release of the drug and prolonging the drug release cycle, making the drug release rate more uniform; specifically, in order to make the outer membrane have a film layer structure that is neither too tight nor too loose, the coating process used can be pneumatic spraying, and multiple back and forth spraying forms the characteristics of layer-by-layer stacking film. In addition, the coating process of the film can also be ultrasonic spraying, electrostatic spraying and other coating methods. In order to control the sudden release of the drug and the drug release rate, while taking into account the tensile and pushing performance of the stent, the thickness of the outer membrane needs to be controlled at 60-100um.
[0038] In one embodiment of the utility model, Figure 2 As shown, the inner membrane 2 is wrapped around the inner wall of the bare stent body 1, the isolation membrane 3 is wrapped around the surface of the bare stent body 1, the drug-loaded membrane 4 is covered on the isolation membrane 3, and the outer membrane is covered on the drug-loaded membrane 4. The inner membrane 2, the bare stent body 1, the isolation membrane 3, the drug-loaded membrane 4, and the outer membrane are stacked in sequence from the inside to the outside. The drug release results are shown in Table 1:
[0039] Drug release time / day Total drug release 1～2 10％～25％ 3～7 25％～45％ 7～14 45％～65％ 14～21 65％～80％ 21～30 80％～95％
[0040] Table 1
[0041] In one embodiment of the utility model, Figure 3 As shown, the inner membrane 2 is covered on the surface of the bare stent body 1, the isolation membrane 3 is covered on the surface of the inner membrane 2, the drug-loaded membrane 4 is covered on the isolation membrane 3, and the outer membrane is covered on the drug-loaded membrane 4. The bare stent limb, the inner membrane 2, the isolation membrane 3, the drug-loaded membrane 4, and the outer membrane are stacked from the inside to the outside. The drug release results are shown in Table 2:
[0042] Drug release time / day Total drug release 1～2 30％～45％ 3～7 45％～70％ 7～14 70％～85％ 14～21 85％～98％
[0043] Table 2
[0044] The controlled-release drug-loaded airway stent provided by the utility model comprises an inner membrane 2, a bare stent body 1, an isolation membrane 3, a drug-loaded membrane 4 and a controlled-release outer membrane 5 which are sequentially arranged from the inside to the outside, by coating the inner membrane 2 on the inner side of the bare stent body 1, and spraying the isolation membrane 3, the drug-loaded membrane 4 and the controlled-release outer membrane 5 on the outer side of the bare stent body 1 in sequence, or, comprises a bare stent body 1, an inner membrane 2, an isolation membrane 3, a drug-loaded membrane 4 and a controlled-release outer membrane 5 which are sequentially arranged from the inside to the outside. The controlled-release drug-loaded airway stent provided by the utility model reconstructs the airway of the narrow section, plays a role of physical support, keeps breathing unobstructed, and can continuously and slowly release the drug after implantation, thereby achieving the purpose of safe and effective treatment.
[0045] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the utility model, rather than to limit it. Although the utility model has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the various embodiments of the utility model.
Claims
1. A controlled-release drug-loaded airway stent, characterized in that: It includes an inner membrane, a bare stent body, an isolation membrane, a drug-loaded membrane and a controlled-release outer membrane which are arranged in sequence from the inside to the outside, wherein the inner membrane is coated on the inner side of the bare stent body, and the isolation membrane, the drug-loaded membrane and the controlled-release outer membrane are sprayed on the outer side of the bare stent body in sequence; or, it includes a bare stent body, an inner membrane, an isolation membrane, a drug-loaded membrane and a controlled-release outer membrane which are arranged in sequence from the inside to the outside.
2. The controlled-release drug-loaded airway stent according to claim 1, characterized in that: The bare stent body is a porous mesh structure of nickel-titanium alloy, the inner diameter of the bare stent body is 8 to 24 mm, the length of the bare stent body is 10 to 80 mm, and the wire diameter of the porous mesh structure is 0.10 to 0.32 mm.
3. The controlled-release drug-loaded airway stent according to claim 2, characterized in that: The inner diameter of the bare stent body is 14 to 22 mm.
4. The controlled-release drug-loaded airway stent according to claim 2, characterized in that: The length of the bare stent body is 20 to 60 mm.
5. The controlled-release drug-loaded airway stent according to claim 2, characterized in that: The wire diameter of the porous mesh structure is 0.18-0.30 mm.
6. The controlled-release drug-loaded airway stent according to claim 2, characterized in that: The coating length of the bare stent body is 60 to 80%.
7. The controlled-release drug-loaded airway stent according to claim 1, characterized in that: The inner membrane is made of medical silicone rubber material.
8. The controlled-release drug-loaded airway stent according to claim 1, characterized in that: The isolation membrane is made of medical polyurethane material.
9. The controlled-release drug-loaded airway stent according to claim 1, characterized in that: A primer is coated between the inner film and the isolation film.
10. The controlled-release drug-loaded airway stent according to claim 1, characterized in that: The outer film is made of medical polyurethane material.