Degradable drug release olfactory cleft stent

Abstract

The utility model belongs to the technical field of medical apparatus and instruments, concretely relates to a degradable medicine slow-release olfactory fissure stent, which comprises a stent main body, the stent main body is arched, is consistent with the dissection shape of the olfactory fissure area, a stent outer layer is arranged on the outer side of the stent main body, and a stent inner layer is arranged on the inner side of the stent main body; a first micropore is arranged on the stent outer layer, a second micropore is arranged on the stent inner layer, and the pore size of the first micropore is greater than that of the second micropore. The slow-release olfactory fissure stent of the technical scheme imitates the natural arc-shaped dissection structure, can realize 360 degree circumferential adhesion, reduces the local compression to the mucosa, the central open channel design accords with the physiological standard of nasal resistance, and avoids the complication of nasal congestion.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a biodegradable drug-releasing olfactory cleft stent. Background Technology

[0002] The olfactory cleft is an important area within the nasal cavity, responsible for the sense of smell. Traditional drug delivery methods often struggle to maintain effective drug concentrations in this area due to the complex anatomical structure of the olfactory cleft and the uncontrollable drug release rate. Traditional sinus stents are mostly hollow cylindrical, relying solely on axial support. Their small contact area with the irregular curved surface of the olfactory cleft makes them prone to stress concentration, leading to mucosal edema or perforation. Furthermore, the axial friction relies on a single contact surface, making them susceptible to slippage during sneezing or nose blowing. Utility Model Content

[0003] The purpose of this invention is to provide a biodegradable drug-releasing olfactory cleft stent that can adapt to the anatomical structure of the olfactory cleft of the nasal cavity and achieve continuous and controllable drug release, thereby solving the core problems of poor anatomical adaptability, sudden drug release, and risk of secondary surgery of traditional stents.

[0004] To achieve the above objectives, this application employs the following technical solution:

[0005] A biodegradable drug-releasing olfactory cleft stent includes a stent body, which is arched and conforms to the anatomical shape of the olfactory cleft region. An outer stent layer is provided on the outside of the stent body, and an inner stent layer is provided on the inside of the stent body.

[0006] A first micropore is provided on the outer layer of the stent, and a second micropore is provided on the inner layer of the stent, wherein the diameter of the first micropore is larger than the diameter of the second micropore.

[0007] Furthermore, the support body is woven from biodegradable polylactic acid-glycolic acid copolymer fibers, and the support body has an arched structure.

[0008] Furthermore, the first micropore on the outer layer of the scaffold has a pore diameter of 50 μm and a pore density of 120 pores / mm².

[0009] Furthermore, a hydrophilic drug layer is loaded within the first micropore.

[0010] Furthermore, the inner layer of the scaffold is a nanofiber membrane prepared from a mixture of PLGA and PEG fibers.

[0011] Furthermore, the pore size of the second micropore on the inner layer of the scaffold is 5-20 nm.

[0012] Furthermore, a hydrophobic drug layer is loaded within the second micropore.

[0013] The beneficial effects of this utility model are:

[0014] The sustained-release olfactory cleft stent of this technical solution mimics the natural arc-shaped anatomical structure, achieving 360° circumferential fit and reducing local pressure on the mucosa; the central open channel design conforms to the physiological standards of nasal resistance, avoiding nasal congestion complications.

[0015] This technical solution utilizes curved surfaces to expand the contact area of ​​the drug sustained-release layer (2-3 times larger than cylindrical surfaces), which can cover the dense area of ​​olfactory nerve endings in the olfactory cleft (approximately 20-30 mm²).

[0016] This technical solution achieves biphasic release (rapid release of antibacterial drugs in the first 24 hours and continuous anti-inflammatory effects in the following 2 weeks) through gradient micropore design and combination with sustained-release materials (such as PLGA). Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the biodegradable drug-releasing olfactory cleft stent of this utility model in use.

[0018] Figure 2 This is a schematic diagram of the biodegradable drug sustained-release olfactory cleft scaffold structure of this utility model.

[0019] Figure 3 for Figure 2 A schematic diagram of the AA section.

[0020] Figure 4 for Figure 2 Enlarged view of point B.

[0021] Figure 5 for Figure 2 Enlarged view of point C.

[0022] Explanation of reference numerals in the attached figures:

[0023] 1. Scaffold; 11. Scaffold body; 12. Outer layer of scaffold; 13. Inner layer of scaffold; 121. First micropore; 131. Second micropore. Detailed Implementation

[0024] The technical solution of this utility model will be described in detail below with reference to the accompanying drawings. The following embodiments are merely exemplary and can only be used to explain and illustrate the technical solution of this utility model, and should not be construed as limiting the technical solution of this utility model.

[0025] like Figures 1 to 5As shown, this application provides a biodegradable drug-releasing olfactory cleft stent. The stent 1 can generally adapt to the anatomical structure of the olfactory cleft of the nasal cavity, including a stent body 11. The stent body of this application is made of polylactic acid-glycolic acid copolymer, wherein the copolymer prepared by polylactic acid (PLGA) and glycolic acid in a weight ratio of 75:25 has a molecular weight of 80kDa, a degradation cycle of 6-8 weeks, and degradation products are CO2 and H2O (excreted through nasal mucus, without toxic accumulation).

[0026] The stent body of this application adopts a biomimetic fiber braiding structure process, using fused deposition modeling (FDM) combined with 0° / 90° cross braiding to improve bending strength; the shape is designed as an arch, consistent with the anatomy of the olfactory cleft. An outer layer 12 is provided on the outside of the stent body 11, and an inner layer 13 is provided on the inside of the stent body 11.

[0027] The outer layer 12 of the stent in this application is laser-engraved with a first micropore 121, the pore diameter is 50 μm and the pore density is 120 pores / mm², and a hydrophilic drug (such as mometasone furoate) is loaded in the first micropore to achieve rapid release within 24 hours (burst release rate <15%).

[0028] The inner layer 13 of the scaffold in this application is a nanofiber membrane prepared by a mixture of PLGA and PEG fibers, wherein the weight percentage of PLGA and PEG is 7:3. The nanofiber membrane is prepared by electrospinning. A second micropore 131 is provided on the inner layer 13 of the scaffold, which is also prepared by laser engraving. The pore size of the second micropore is 5-20 nm. A hydrophobic drug layer (such as cyclosporine A) is loaded in the second micropore, with a sustained release period of 28 days (zero-order kinetic fit R²>0.98).

[0029] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A biodegradable drug-releasing olfactory cleft stent, characterized in that, It includes a stent body, which is arched and conforms to the anatomical shape of the olfactory cleft. An outer stent layer is provided on the outside of the stent body, and an inner stent layer is provided on the inside of the stent body. A first micropore is provided on the outer layer of the stent, and a second micropore is provided on the inner layer of the stent, wherein the diameter of the first micropore is larger than the diameter of the second micropore.

2. The biodegradable drug-releasing olfactory cleft scaffold according to claim 1, characterized in that, The main body of the support is woven from biodegradable polylactic acid-glycolic acid copolymer fibers, and the main body of the support has an arched structure.

3. The biodegradable drug-releasing olfactory cleft scaffold according to claim 1, characterized in that, The first micropore on the outer layer of the scaffold has a pore size of 50 μm and a pore density of 120 pores / mm².

4. The degradable drug-releasing olfactory cleft stent of claim 3, wherein, A hydrophilic drug layer is loaded within the first micropore.

5. The biodegradable drug-releasing olfactory cleft stent according to claim 1, characterized in that, The inner layer of the scaffold is a nanofiber membrane made of a mixture of PLGA and PEG fibers.

6. The biodegradable drug-releasing olfactory cleft stent according to claim 5, characterized in that, The second micropore on the inner layer of the scaffold has a pore size of 5-20 nm.

7. The degradable drug-releasing olfactory cleft stent of claim 6, wherein, A hydrophobic drug layer is loaded within the second micropore.

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