CN114832218B

CN114832218B - Intranasal drug stent

Info

Publication number: CN114832218B
Application number: CN202210223643.7A
Authority: CN
Inventors: 张立争; 常兆华; 戴雯婕; 黄凯楠; 陈志远; 张劼; 罗七一
Original assignee: Shanghai Microport Medical Technology Co ltd
Current assignee: Shanghai Microport Medical Technology Co ltd
Priority date: 2021-10-27
Filing date: 2021-10-27
Publication date: 2023-12-05
Anticipated expiration: 2041-10-27
Also published as: CN113679936B; CN114832218A; CN113679936A

Abstract

The application relates to a medicine support for intranasal use, which comprises a main section and a first auxiliary section, wherein the main section comprises a support framework, a membrane layer and a medicine layer, the support framework can be pressed and held along the radial direction, the diameter of the support framework is reduced, the membrane layer is attached and fixed on the support framework, the medicine layer is attached on the membrane layer, the first auxiliary section is positioned at one end of the main section, the first auxiliary section comprises a plurality of first bulges, the first bulges are far away from the distal end of the support framework, and form a first included angle with the axial downward direction of the support framework, and are acute angles.

Description

Intranasal drug stent

The application is a divisional application of China patent application of which the application date is 2021, 10 and 27, the application number is 2021112523611 and the application name is 'degradable drug stent system'.

Technical Field

The application relates to the technical field of medical appliances, in particular to a medicament support for intranasal use.

Background

Chronic sinusitis is one of the common diseases of otorhinolaryngology, and is caused by nasal obstruction, runny nose, headache, dizziness and other symptoms, which seriously affect the quality of life of patients and prevent normal work. The traditional operation is adopted to treat chronic nasosinusitis, so that the problems of serious intra-cavity adhesion, high restenosis rate and the like after the operation are solved, and the problem of tissue adhesion and re-operation is often avoided by placing a nasosinusitis bracket in a nasal cavity after the operation.

In clinic, the hemorrhage in the absorption operation of the Naxi cotton is usually adopted, and the Naxi cotton needs to be manually taken out for the second time. The adverse reactions such as inflammation are usually reduced by adopting methods such as local administration or oral administration, and the problems of low use efficiency and poor drug effect of the local administration or oral administration are solved, and the steps of postoperative intervention are added, so that the postoperative life of a patient is influenced.

Disclosure of Invention

Accordingly, there is a need for an intranasal drug stent that can accurately release a drug within a certain period of time without taking out a filler, that can improve the drug administration efficiency, that can reduce the adverse reaction after the operation, and that can reduce the pain of the patient.

An intranasal drug stent comprising:

the main section comprises a bracket framework, a membrane layer and a medicine layer, wherein the bracket framework is made of degradable materials, the bracket framework is integrally cylindrical, the bracket framework can be pressed and held along the radial direction, the diameter of the bracket framework is reduced, the membrane layer is made of degradable materials, the membrane layer is attached and fixed on the bracket framework, and the medicine layer is attached on the membrane layer; and

The first from the section, set up in the one end of main section, first from the section include a plurality of first archs, a plurality of first protruding edge the circumferencial direction interval distribution of main section, first protruding keep away from the distal end of support skeleton with the axis of support skeleton is the acute angle in the first extending direction of axis first formation.

In one embodiment, the intranasal medicament stent further comprises a second slave segment, the second slave segment is arranged at the other end of the master segment, the second slave segment comprises a plurality of second protrusions, the second protrusions are distributed at intervals along the circumferential direction of the master segment, a second interval is arranged between every two adjacent second protrusions, the second interval penetrates through the second slave segment along the extending direction of the second protrusions, and a second included angle formed by the distal end of the second protrusions, which is far away from the stent framework, and the axis of the stent framework in the second extending direction of the axis is an acute angle.

In one embodiment, the membrane layer has a plurality of micro-scale voids formed therein for attaching a drug to form a drug layer.

In one embodiment, the axial length L of the main section ranges from 10mm to 20mm.

In one embodiment, the first slave segment has an axial length of 1/12L to 1/2L.

In one embodiment, the stent scaffold has a maximum diameter in the range of 20mm to 50mm.

In one embodiment, the first included angle ranges from 15 ° to 75 °.

In one embodiment, the first protrusion extends from a junction with the stent scaffold to a distal end distal from the stent scaffold in a straight line or a curve.

In one embodiment, the number N1 of the first protrusions is 4+.n1+.15.

In one embodiment, the second slave segment has an axial length of 1/12L to 1/2L and the second slave segment has an axial length less than the axial length of the first slave segment.

In one embodiment, the second included angle is in the range of 15 ° to 75 °.

In one embodiment, the second protrusion extends from a junction with the stent scaffold to a distal end distal from the stent scaffold in a straight line or a curve.

In one embodiment, the number N1 of the second protrusions is 4+.n2+.15.

In one embodiment, the scaffold is composed of one or more of the following polymers: polylactic acid, L-polylactic acid, polylactic acid-glycolic acid copolymer, polycaprolactone, polyurethane, polyglycerol sebacate, polybutylene succinate, polyethylene glycol-polylactic acid block copolymer, polyethylene glycol-polylactic acid-glycolic acid triblock copolymer; and/or

The membrane layer is prepared from a biological natural polymer material or a biological synthetic polymer material, wherein the biological natural polymer material comprises the following materials: chitosan, silk fibroin, gelatin, cellulose or chitin; the biosynthesis polymer material comprises the following materials: polylactic acid, L-polylactic acid, polylactic acid-glycolic acid copolymer, polycaprolactone, polyurethane, polyglycerol sebacate, polybutylene succinate, polyethylene glycol-polylactic acid block copolymer or polyethylene glycol-polylactic acid-glycolic acid triblock copolymer.

In one embodiment, the film layer is attached and fixed on the bracket framework in a spraying, electrostatic spinning or glue connection mode; and/or

The drug layer is attached to the film layer by spray coating or dip coating.

The intranasal medicament stent has at least the following advantages:

when the intranasal medicine support is implanted into the postoperative nasal cavity from the nostril, the main section is located the nasal cavity more inside, and first follow section is located the nasal cavity more outside, and a plurality of first archs are along the circumferencial direction interval distribution of main section, and the distal end that the support skeleton was kept away from to first arch is the acute angle with the first contained angle that the axis of support skeleton formed in the first extending direction of axis, therefore first arch not only easily blocks at the nasal cavity inner wall, and convenient pressure is held in the whole along radial direction of intranasal medicine support of usefulness in addition when being pressed and is held, and first arch can not be crushed. Further, the interval is arranged between the two adjacent first bulges, the interval is also arranged between the two adjacent second bulges, after the implantation of the nasal cavity, the tissue of the nasal cavity wall can be embedded into the intervals, so that the anchoring effect of the first slave section and the second slave section is improved, the positioning effect and the positioning precision of the drug stent are further improved, more importantly, the interaction force among the plurality of first bulges with the interval is small, so that the first slave section has better compliance, the first slave section is easier to press and hold, and the implantation of the drug stent for intranasal use is facilitated. Similarly, the second protrusions with the gaps have small interaction force, so that the second slave section has better compliance, the second slave section is easier to press and hold, and the implantation of the intranasal medicament stent is facilitated. The membrane layer is firmly extruded on the inner wall of the nasal cavity by the support frame, and the postoperative wound on the inner wall of the nasal cavity can be plugged by the membrane layer, so that the membrane layer can prevent postoperative bleeding, and a drug layer formed by drugs is attached to the membrane layer, so that the drug layer is coated on the outer surface of the support frame and directly contacted with the inner wall of the nasal cavity, the drugs can be precisely and slowly released within a certain time, the use efficiency of the drugs is improved, adverse reactions after the operation are reduced, and the pain of a patient is reduced. And the bracket framework and the film layer are both degradable materials, so that the bracket is degraded after a degradation period, secondary taking out is not needed, and secondary damage to a patient is avoided.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this specification, illustrate embodiments of the application and together with the description serve to explain the application.

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for the description of the embodiments will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic structural view of an intranasal drug stent according to one embodiment;

FIG. 2 is a schematic partial cross-sectional view of the intranasal drug stent of FIG. 1;

FIG. 3 is a schematic structural view of a degradable drug stent system in an embodiment in which a stent crimping device carrying a crimped state of an intranasal drug stent is aligned with a delivery device;

FIG. 4 is a schematic view of the stent crimping device of FIG. 3;

FIG. 5 is a schematic illustration of the placement of an intranasal drug stent in the stent crimping device of FIG. 4 in an initial state;

fig. 6 is a schematic view of the stent crimping device of fig. 4 in a crimped state for crimping a drug stent for intranasal use.

Reference numerals illustrate:

1. a drug stent for intranasal use; m, a main section; m1, a first slave segment; m2, a second slave segment; 101. a stent framework; 103. a film layer; 104. a drug layer; 102. a first protrusion; 105. a second protrusion; 2. a bracket press-grip; 3. a conveyor; 21. a push rod; 22. a first case; 221. an elastic member; 25. a connection part; 23. a press grip; 24. a second case; 211. a limit protrusion; 222. a through hole; 223. a hollow cavity; 212. a handle; 233. a via hole; 231. a limit rod; 234. pressing the holding belt; 232. a handle; 244. a mating hole; 243. an access hole; 242. a holding hole; 241. a connection hole; 31. a delivery head end; 32. and a conveying rod.

Detailed Description

In order that the above objects, features and advantages of the application will be readily understood, a more particular description of the application will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. The present application may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the application, whereby the application is not limited to the specific embodiments disclosed below.

As shown in fig. 1 and 2, the intranasal drug stent 1 according to one embodiment includes a main section M, a first sub section M1, and a second sub section M2, the first sub section M1 and the second sub section M2 being located at opposite ends of the main section M, respectively. When the intranasal drug stent 1 is implanted into the post-operative nasal cavity from the nostril, the second slave M2 is located innermost in the nasal cavity relative to the master M and the first slave M1, the master M is located more inwardly in the nasal cavity, and the first slave M1 is located more outwardly in the nasal cavity. The main section M mainly has the functions of medicine slow release and hemostasis, and the first auxiliary section M1 and the second auxiliary section M2 mainly have the functions of enhancing supporting performance.

Referring to fig. 1, the main section M includes a stent framework 101, a membrane layer 103 and a drug layer 104, wherein the stent framework 101 is made of a degradable material, the stent framework 101 is cylindrical as a whole, a plurality of meshes are formed on the side wall of the stent framework 101, and the stent framework 101 can be pressed in a radial direction to reduce the diameter.

Specifically, the axial length L of the main section M ranges from 10mm to 20mm. Because the overall depth dimension of the nasal cavity is certain, if the axial length L of the main section M is too large, the medicine support 1 for the nose cannot be smoothly implanted into the nasal cavity; if the axial length L of the main section M is too small, the range of the inner wall of the nasal cavity covered by the main section M is too small, and the whole nasal cavity cannot be effectively distracted. Therefore, the range of the axial length L of the main section M is set to be 10mm to 20mm, so that the nasal cavity can be smoothly implanted, and the whole nasal cavity can be effectively spread.

The stent scaffold 101 is composed of one or more of the following polymers: polylactic acid, L-polylactic acid, polylactic acid-glycolic acid copolymer, polycaprolactone, polyurethane, polyglycerol sebacate, polybutylene succinate, polyethylene glycol-polylactic acid block copolymer, polyethylene glycol-polylactic acid-glycolic acid triblock copolymer. The scaffold 101 can be degraded into water and carbon dioxide according to specific use conditions, and the degradation period is determined, preferably within a range of 1 to 3 months, by the material proportion.

The stent scaffold 101 has a maximum diameter in the range of 20mm to 50mm. Because the overall width dimension of the nasal cavity is fixed, if the maximum diameter range of the stent framework 101 is too large, the diameter range of the intranasal drug stent 1 is too large in the press-holding state, and the intranasal drug stent 1 cannot be smoothly implanted into the nasal cavity; if the maximum diameter range of the stent framework 101 is too small, the drug stent 1 for intranasal use cannot effectively prop open the entire nasal cavity after being prop-open. Therefore, the maximum diameter range of the stent framework 101 is set to be 20mm to 50mm, so that the stent framework can be smoothly implanted into the nasal cavity and the whole nasal cavity can be effectively spread.

The bracket framework 101 can be woven by high polymer degradable material wires or cut by high polymer degradable material pipes, so that the bracket framework 101 forms a net structure, and a plurality of meshes are formed on the side wall of the bracket framework 101. For example, the mesh may be a diamond mesh, or an arcuate cross diamond mesh, or an irregular mesh.

The membrane layer 103 is made of degradable materials, the membrane layer 103 is attached and fixed on the bracket framework 101, and the drug layer 104 is attached to the membrane layer 103.

The membrane layer 103 is made of a bio-natural polymer material or a bio-synthetic polymer material, and the bio-natural polymer material includes but is not limited to the following materials: chitosan, silk fibroin, gelatin, cellulose, and chitin; the biosynthetic polymeric materials include, but are not limited to, the following: polylactic acid, L-polylactic acid, polylactic acid-glycolic acid copolymer, polycaprolactone, polyurethane, polyglycerol sebacate, polybutylene succinate, polyethylene glycol-polylactic acid block copolymer, polyethylene glycol-polylactic acid-glycolic acid triblock copolymer. The film layer 103 can be degraded into water and carbon dioxide according to specific use conditions, and the degradation period is preferably 1 to 3 months, and is realized through the material proportion.

The film layer 103 is attached and fixed on the bracket framework 101 by spraying, electrostatic spinning or glue connection. The spraying mode has the advantage that the film layer 103 can be uniformly attached to the bracket framework 101; the electrostatic spinning mode has the advantages that the film with the nanofiber structure can be attached to the surface of the bracket framework 101, and the structure can promote the regeneration of nasal sinus tissues; the advantage of the glue connection mode is that the film layer 103 is tightly attached to the bracket framework 101, and is not easy to fall off.

Further, the membrane layer 103 is formed with a plurality of micro-scale pores, the pores are used for attaching the drug to form the drug layer 104, the membrane layer 103 plays a role of a drug carrier for slow release of the drug, and the pores increase the attaching area of the drug layer 104, so that the slow release effect is improved.

The drug layer 104 is attached to the film layer 103 by spray coating or dip coating. The spray coating method has the advantage of more uniform drug adhesion, and the dip coating method has the advantage of simple operation.

The medicine layer 104 is a slow-release medicine, which comprises medicines for treating nasosinusitis, anti-inflammatory medicines, hemostatic medicines and the like. Drugs for the treatment of sinusitis include glucocorticoids and macrolides. The glucocorticoid drugs used include, but are not limited to: mometasone furoate, prednisone, methylprednisone, betamethasone, beclomethasone propionate, prednisolone, hydrocortisone, dexamethasone; macrolides used include, but are not limited to, erythromycin, roxithromycin, azithromycin, clarithromycin; anti-inflammatory drugs include, but are not limited to: salicylic acid derivatives, aspirin, sodium salicylate; hemostatic drugs include, but are not limited to, heparin sodium, low molecular weight heparin, heparinoids, hirudin, and the like. The slow-release medicine is slowly released in the degradation period of the stent framework 101, and the release rate, concentration and period are realized by proportioning.

When the intranasal drug stent 1 is implanted into the nasal cavity after operation from the nostril, the membrane layer 103 is firmly extruded on the inner wall of the nasal cavity by the stent framework 101, and the membrane layer 103 can seal the postoperative wound on the inner wall of the nasal cavity, so that the membrane layer 103 can prevent postoperative bleeding, and the membrane layer 103 is attached with the drug layer 104 formed by the drug, therefore, the drug layer 104 is coated on the outer surface of the stent framework 101 and directly contacted with the inner wall of the nasal cavity, so that the drug can be precisely and slowly released in a certain time, the drug use efficiency is improved, the postoperative adverse reaction is reduced, and the pain of a patient is reduced. And the bracket framework 101 and the film layer 103 are both degradable materials, so that the bracket is degraded after a degradation period, secondary taking out is not needed, and secondary damage to a patient is avoided.

Referring to fig. 1 and 2, a first slave segment M1 is disposed at one end of the master segment M, the first slave segment M1 includes a plurality of first protrusions 102, the plurality of first protrusions 102 are distributed at intervals along a circumferential direction of the master segment M, and a first included angle θ formed between a distal end of the first protrusion 102, which is far from the bracket framework 101, and an axis of the bracket framework 101 in a first extending direction of the axis is an acute angle.

When the intranasal drug stent 1 is implanted into the post-operative nasal cavity from the nostril, the main section M is positioned relatively inward of the nasal cavity (i.e., the main section is far away from the nostril), the first sub-section M1 is positioned relatively outward of the nasal cavity (i.e., the first sub-section is close to the nostril), the plurality of first protrusions 102 are spaced apart along the circumferential direction of the main section M, the distal end of the first protrusions 102 away from the stent framework 101 (i.e., the end of the first protrusions 102 close to the nostril) forms a first angle θ with the axis of the stent framework 101 in the first axial extension direction (i.e., the nostril extension direction), and therefore the first protrusions 102 are not only easily caught on the inner wall of the nasal cavity, but also are convenient to press-grip when the entire intranasal drug stent 1 is pressed in the radial direction. Meanwhile, a space is reserved between two adjacent first bulges 102, after the intranasal implantation, cavity wall tissues in the nose can be embedded into the space between two adjacent first bulges 102, so that the anchoring effect of the first slave section m1 is improved, and the positioning effect and the positioning precision of the intranasal medicament stent 1 are further improved. More importantly, the first plurality of protrusions 102 have a small interaction force therebetween, thereby providing the first slave segment m1 with a better compliance, making the first slave segment m1 easier to squeeze, and facilitating implantation of the intranasal drug stent 1.

Further, the axial length of the first slave segment m1 is 1/12L to 1/2L. The first slave m1 is clamped on the inner wall of the nasal cavity to increase the supporting performance. Because the distal end of the first protrusion 102 away from the bracket skeleton 101 and the first included angle θ formed by the axis of the bracket skeleton 101 in the first extending direction of the axis are acute angles, the whole first slave segment M1 and the master segment M form a certain included angle, if the axial length of the first slave segment M1 is too large, the diameter difference between the master segment M and the distal end of the first slave segment M1 is too large, which can cause the suspension of the master segment M after implantation into the inner wall of the nasal cavity, and the attachment on the inner wall of the nasal cavity is impossible. If the axial length of the first secondary segment m1 is too small, the wall cannot be grasped, the supporting force cannot be provided, and the intranasal drug stent 1 cannot be fixed on the inner wall of the nasal cavity. Therefore, the axial length of the first slave section M1 is set to be 1/12L to 1/2L, so that the master section M can be tightly attached to the inner wall of the nasal cavity, and the first slave section M1 can be firmly fixed on the inner wall of the nasal cavity to form a barb structure.

Further, the first included angle θ ranges from 15 ° to 75 °. For example, the first included angle θ is 45 °. If the first included angle θ is too large, the whole of the intranasal drug stent 1 cannot be gripped, the first protrusions 102 are also easily crushed, and if the first included angle θ is too small, the intranasal drug stent 1 is not easily stuck on the inner wall of the nasal cavity. Therefore, the range of the first included angle θ is set to 15 ° to 75 °, so that the whole of the intranasal medicine stent 1 can be ensured to be held by pressure well, the first protrusions 102 can not be crushed, and the intranasal medicine stent 1 can be firmly clamped on the inner wall of the nasal cavity.

Further, the first protrusion 102 extends from a connection with the stent framework 101 to a distal end away from the stent framework 101 in a straight line or a curved line. For example, in the present embodiment, the first protrusion 102 extends from the connection portion with the stent framework 101 to the distal end far from the stent framework 101 to form a curve, so that when the first protrusion 102 is snapped onto the inner wall of the nasal cavity, the fitting degree with the inner wall of the nasal cavity is better, and the supporting performance is better; and the medicament stent 1 for intranasal use has better adaptability when being pressed and held.

Further, the number N1 of the first protrusions 102 is equal to or less than 4 and equal to or less than 15. The preferable range is 7.ltoreq.N1.ltoreq.11. If the number of first protrusions 102 is too large, it may result in a poor grip of the intranasal drug stent 1; if the number of the first protrusions 102 is too small, the fit may be poor. Therefore, the number N1 of the first protrusions 102 is set to be 4+.n1+.15, which can be well pressed and held, and the bonding degree is good.

Referring to fig. 1 and 2 again, the second slave segment M2 is disposed at the other end of the master segment M, the master segment M is located between the first slave segment M1 and the second slave segment M2, the second slave segment M2 includes a plurality of second protrusions 105, the second protrusions 105 are distributed at intervals along the circumferential direction of the master segment M, and a second included angle β formed between a distal end of the second protrusion 105 away from the bracket framework 101 and an axis of the bracket framework 101 in the second extending direction of the axis is an acute angle.

When the intranasal drug stent 1 is implanted into the post-operative nasal cavity from the nostril, the second slave M2 is located innermost in the nasal cavity (i.e., the second slave is furthest from the nostril) than the master M and the first slave M1, the master M is located further inside the nasal cavity (the master is farther from the nostril), the first slave M1 is located further outside the nasal cavity (the first slave is closer to the nostril), the plurality of second protrusions 105 are spaced apart in the circumferential direction of the master M, and the distal ends of the second protrusions 105 distal from the stent framework 101 (the ends of the second protrusions 105 distal from the nostril) form an acute angle with the axis of the stent framework 101 in the second direction of extension of the axis (i.e., the direction of extension of the nostril into the interior of the nasal cavity), so that the second protrusions 105 are not only easily caught on the inner wall of the nasal cavity, but also are easily pressed when the intranasal drug stent 1 is pressed in the radial direction as a whole. The second protrusion 105 of the second slave M2 is engaged with the inner wall of the nasal cavity, the first protrusion 102 of the first slave M1 is engaged with the outer wall of the nasal cavity, and the master M is attached to the inner wall of the nasal cavity. Further, there is a space between two adjacent second protrusions 105, and after the implantation in the nose, the cavity wall tissue in the nose can be embedded into the space between two adjacent second protrusions 105, so as to improve the anchoring effect of the second slave m2, and further improve the positioning effect and the positioning accuracy of the medicament stent 1 for the nose. More importantly, the second plurality of protrusions 105 with the spacing therebetween have a small interaction force, thereby providing the second slave segment m2 with a better compliance, making the second slave segment m2 easier to squeeze, facilitating implantation of the intranasal drug stent 1.

Further, the axial length of the second slave section m2 is 1/12L to 1/2L, and the axial length of the second slave section m2 is smaller than the length of the first slave section m 1. Because the second protrusion 105 is far away from the distal end of the stent framework 101 and the second included angle β formed by the axis of the stent framework 101 in the direction of the second extending direction of the axis is an acute angle, the whole second slave segment M2 forms a certain included angle with the master segment M, if the axial length of the second slave segment M2 is too large, the diameter difference between the distal ends of the master segment M and the second slave segment M2 is too large, which can cause the suspension of the master segment M after implantation into the inner wall of the nasal cavity, and the attachment on the inner wall of the nasal cavity is impossible. If the axial length of the second sub-section m2 is too small, the wall cannot be grasped, the supporting force cannot be provided, and the intranasal drug stent 1 cannot be fixed on the inner wall of the nasal cavity. Therefore, the axial length of the second slave section M2 is set to be 1/12L to 1/2L, so that the master section M can be closely attached to the inner wall of the nasal cavity, and the second slave section M2 can be firmly fixed on the inner wall of the nasal cavity to form a hook structure. Because the nasal cavity is flared, the axial length of the second slave section m2 is smaller than that of the first slave section m1, and the nasal cavity can be matched with the shape of the nostril.

Further, the second included angle β ranges from 15 ° to 75 °. For example, the second angle β is 45 °. If the second angle β is too large, the whole of the intranasal drug stent 1 cannot be gripped, the second protrusions 105 are also easily crushed, and if the second angle β is too small, the intranasal drug stent 1 is not easily stuck on the inner wall of the nasal cavity. Therefore, the second included angle β is set to 15 ° to 75 °, so that the entire intranasal medicine stent 1 can be ensured to be held by a good pressure, the second protrusions 105 are not crushed, and the intranasal medicine stent 1 can be firmly clamped on the inner wall of the nasal cavity.

Further, the second protrusion 105 is linear or curved from the connection with the stent framework 101 to the distal end away from the stent framework 101. For example, in the present embodiment, the second protrusion 105 extends from the connection portion with the stent framework 101 to the distal end far from the stent framework 101 to form a curve, so that when the second protrusion 105 is snapped onto the inner wall of the nasal cavity, the fitting degree with the inner wall of the nasal cavity is better, and the supporting performance is better; and the medicament stent 1 for intranasal use has better adaptability when being pressed and held.

Further, the number N2 of the second protrusions 105 is 4+.n2+.15. The preferable range is 7.ltoreq.N2.ltoreq.11. If the number of second protrusions 105 is too large, it may result in a poor grip of the intranasal drug stent 1; if the number of the second protrusions 105 is too small, poor fitting may result. Therefore, the number N2 of the second protrusions 105 is set to be 4+.n2+.15, so that the press grip and the bonding degree are good.

Of course, in other embodiments, the second slave M2 may be omitted from the intranasal drug stent 1, and the intranasal drug stent 1 includes a master M and a first slave M1, wherein the master M is positioned inside the nasal cavity and the first slave M1 is positioned outside the nasal cavity when the intranasal drug stent 1 is implanted in the nasal cavity after the operation.

Referring to fig. 3, a degradable drug stent system in one embodiment comprises a stent crimping device 2, a delivery device 3, and a drug stent 1 for intranasal use as described above. Referring to fig. 4 to 6, the stent crimping device 2 in an embodiment is mainly used for crimping an intranasal drug stent 1 from an initial state to a crimped state, and pushing the intranasal drug stent 1 in the crimped state into a conveyor 3, so as to facilitate the subsequent conveyance of the intranasal drug stent 1 in the crimped state to a target position in a nasal cavity of a patient through a conveying tube.

Specifically, the holder presser 2 includes a push rod 21, a first case 22, an elastic member 221, a connecting portion 25, a pressing portion 23, and a second case 24.

The periphery side of push rod 21 is provided with spacing protruding 211, first box 22 is equipped with the through-hole 222 that runs through and is equipped with the cavity 223 that is linked together with through-hole 222, the one end of push rod 21 stretches into in the cavity 223 through a through-hole 222, spacing protruding 211 limit is located in the cavity 223, the diameter of spacing protruding 211 is greater than the internal diameter of through-hole 222, avoids push rod 21 to deviate from in the through-hole 222. The inner diameter of the hollow cavity 223 is larger than the inner diameter of the through hole 222 to accommodate the elastic member 221 and the limit protrusion 211. Specifically, the push rod 21 is cylindrical, the limiting protrusion 211 is a circular protrusion formed in the middle of the push rod 21, the first box 22 is cylindrical, the hollow cavity 223 is cylindrical, the through hole 222 is a circular hole, and the axes of the hollow cavity 223 and the through hole 222 are coincident with the axis of the push rod 21. The other end of the push rod 21 is further provided with a handle 212, the other end of the push rod 21 extends out of the hollow cavity 223 of the first box 22, and the handle 212 is convenient for an operator to push the push rod 21 and can prevent the push rod 21 from excessively extending into the through hole 222 of the first box 22.

The elastic member 221 is sleeved at one end of the push rod 21 and is located in the hollow cavity 223, one end of the elastic member 221 abuts against the limiting protrusion 211, and the other end of the elastic member 221 abuts against the top wall of the first box 22. The elastic member 221 is provided for the purpose of providing a restoring elastic force for restoring the push rod 21. Specifically, the elastic member 221 may be a compression spring, and the compression spring is integrally located in the hollow cavity 223. Of course, in other embodiments, the elastic member 221, the limiting protrusion 211, and the hollow cavity 223 may be omitted.

The connection portion 25 is located between the first case 22 and the second case 24, and a via 233 is formed on the connection portion 25. In the present embodiment, the connecting portion 25 has a semicircular shape, and the axis of the connecting portion 25 coincides with the axis of the through hole 222 of the first casing 22 and the axis of the push rod 21.

One end of the pressing and holding part 23 is fixed on the connecting part 25, the other end of the pressing and holding part 23 is a free end, the free end of the pressing and holding part 23 is used for penetrating through the through hole 233 to form a circular ring with a variable diameter, a limit rod 231 is arranged on the outer side surface of the pressing and holding part 23, and the limit rod 231 is used for being clamped into the through hole 233.

Specifically, in this embodiment, the press-holding portion 23 includes a press-holding belt 234, one end of the press-holding belt 234 is fixed on the connecting portion 25, the other end of the press-holding belt 234 is a free end, the free end of the press-holding belt 234 passes through the through hole 233 to form a circular ring with a variable diameter, and the limit lever 231 is disposed on an outer side surface of the press-holding belt 234. For example, when the holding strap 234 is unfolded, the holding strap 234 is rectangular, one end of the holding strap 234 is fixed on the connecting portion 25, and the free end of the holding strap 234 passes through the through hole 233 to form a circular ring with a variable diameter, and the initial diameter of the circular ring with the variable diameter is larger than that of the intranasal medicine stent 1, so that the intranasal medicine stent 1 can be reliably placed in the circular ring. The crimping strips 234 are typically made of a softer material, preferably polyethylene or polyvinyl chloride, from a medical grade material.

The press grip 23 further includes a handle 232, and the handle 232 is disposed at a free end of the press grip belt 234. The pull tab 232 is used for manual stretching to change the diameter of the variable diameter ring formed by the crimping strap 234. For example, the pull 232 may be integrally formed with the crimping strap 234. The free end of the handle 232 is provided with a rounded chamfer to facilitate passage through the via 233.

The axial width of the press-grip 234 is smaller than the axial width of the through hole 233, and the thickness of the press-grip 234 is smaller than the radial width of the through hole 233. The axial direction here means the axial direction of the connecting portion 25, the push rod 21, and the first casing 22, and the radial direction means the radial direction of the connecting portion 25. Accordingly, the crimping strap 234 can smoothly move back and forth in the via 233.

The limit rod 231 extends along the axial direction, the axial width of the limit rod 231 is smaller than or equal to the axial width of the through hole 233, and the diameter of the limit rod 231 is larger than the radial width of the through hole 233. The limit bar 231 is fixed on the outer side surface of the holding belt 234, so that the medicine support 1 for the nose is held to limit the required diameter. When the handle 232 is continuously pulled, the diameter of the circular ring with the variable diameter formed by the pressing and holding belt 234 is reduced, and finally the circular ring is blocked by the limiting rod 231, the limiting rod 231 is clamped into the through hole 233, and the intranasal medicine stent 1 is pressed and held in the stent pressing and holding device 2.

The second case 24 is provided with a mating hole 244, and the through hole and the ring are communicated with the mating hole 244. Specifically, the outer portion of the second casing 24 is conical and gradually decreases in outer diameter in a direction away from the first casing 22. The axis of the fitting hole 244 coincides with the axis of the connecting portion 25, the push rod 21, and the first casing 22. In the process that the handle 232 pulls the press-holding belt 234 to reduce the diameter of the circular ring with the variable diameter formed by the press-holding belt 234, the press-holding belt 234 always keeps a cylindrical shape, and the axes approach to the axis of the matching hole 244 of the second box 24, and finally coincide.

The mating hole 244 includes an access hole 243, a holding hole 242, and a connecting hole 241, which are sequentially connected and have coincident axes, the access hole 243 is in communication with a circular ring formed by the press grip 23 and having a variable diameter, the holding hole 242 is located between the access hole 243 and the connecting hole 241, and the connecting hole 241 is used for connecting the conveyor 3.

Specifically, the inlet hole 243 is tapered, and a large diameter section of the inlet hole 243 is engaged with a circular ring with a variable diameter formed by the pressing part 23, and the diameter of the large diameter section is slightly larger than the final pressing diameter of the intranasal medicine holder 1, so that the pressed intranasal medicine holder 1 can conveniently enter the second box 24. The small diameter section of the entry hole 243 is engaged with the holding hole 242, and the diameter of the small diameter section is the final diameter after the intranasal medicine stent 1 is crimped. The holding hole 242 and the connecting hole 241 are both cylindrical holes, and the diameter of the connecting hole 241 is larger than the diameter of the holding hole 242. The diameter of the hole 242 is kept constant and is the final diameter of the hold-down of the intranasal drug stent 1. The connecting hole 241 is used for connecting the conveyor 3, and the diameter is the diameter of the outer wall of the conveying head end 31 of the conveyor 3, so that the conveying head end 31 can be inserted into the connecting hole 241.

Referring to fig. 3, the conveyor 3 includes a conveying head 31 and a conveying rod 32, and one end of the conveying rod 32 extends into the conveying head 31. The delivery head end 31 is used for bearing the intranasal medicine support 1 in a press-holding state, the delivery head end 31 is of a tubular structure, the inside of the delivery head end receives the press-held intranasal medicine support 1, the diameter of the inner wall is the press-holding diameter of the intranasal medicine support 1, and the outer wall is connected with the connecting hole 241. By the action of the delivery rod 32, the intranasal drug stent 1 in the delivery head end 31 is pushed out, and the intranasal drug stent 1 is delivered to the nasal cavity target position, so that the intranasal drug stent 1 is restored to the original state and acts on the target position. The rest of the pressing and holding part 23 except the elastic part 221, the pressing and holding belt 234 and the handle 232 can be made of common medical plastic materials, preferably polyethylene.

Referring to fig. 5, the intranasal medicament stent 1 in the initial state is placed in a circular ring with a variable diameter formed by the pressing and holding part 23, then the length of the pressing and holding part 23 penetrating through the through hole 233 is changed (namely, the position of the free end of the pressing and holding part 23 relative to the through hole 233 is changed), so that the pressing and holding part 23 is slowly contracted, the diameter of the circular ring is slowly reduced, the intranasal medicament stent 1 is compressed, referring to fig. 6, until the limit rod 231 is clamped into the through hole 233, and the deformation of the intranasal medicament stent 1 from the initial state to the pressing and holding state is completed. Referring to fig. 3, the connection hole 241 of the press grip carrying the intranasal drug stent 1 is aligned with the delivery head end 31 of the delivery device 3 such that the delivery head end 31 of the delivery device 3 is inserted into the connection hole 241 up to the bottom of the connection hole 241, and kept at this position, at this time, the push rod 21 is slowly pushed toward the second case 24, one end of the push rod 21 near the intranasal drug stent 1 slowly pushes the intranasal drug stent 1 out of the press grip 23, and is delivered into the delivery head end 31 of the delivery device 3 through the entrance hole 243, the holding hole 242 and the connection hole 241 of the second case 24 in this order, and when the push rod 21 is pushed to the maximum position, the intranasal drug stent 1 is just completely press-gripped into the delivery head end 31 of the delivery device 3. The conveyer 3 carrying the intranasal medicine stent 1 in the press-holding state is pushed to the target release position of the intranasal medicine stent 1 by the conveyer head end 31 of the conveyer 3 under the cooperation of an endoscope according to clinical requirements, the conveying rod 32 is slowly pushed, the intranasal medicine stent 1 is completely pushed out of the conveyer head end 31, and the intranasal medicine stent 1 can be self-expanded from the press-holding state to the initial state, so that the implantation of the intranasal medicine stent 1 is completed.

Therefore, the intranasal medicine stent 1 is pressed and held to the pressing and holding state by the pressing and holding part 23, and then is pushed into the delivery head end 31 of the delivery device 3 by the push rod 21 from the pressing and holding part 23 through the matching hole 244, and the intranasal medicine stent 1 is always in the pressing and holding state in the pushing and delivering process, so that the stent pressing and holding failure rate can be reduced, the convenience and reliability are realized, and the operation is simple.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the application. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present application and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present application.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present application, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present application, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

Claims

1. An intranasal drug stent, comprising:

the main section comprises a bracket framework, a membrane layer and a medicine layer, wherein the bracket framework is made of degradable materials, the bracket framework is integrally cylindrical, the bracket framework can be pressed and held along the radial direction, the diameter of the bracket framework is reduced, the membrane layer is made of degradable materials, the membrane layer is attached and fixed on the bracket framework, and the medicine layer is attached on the membrane layer;

the first auxiliary section is arranged at one end of the main section and comprises a plurality of first bulges, the first bulges are distributed at intervals along the circumferential direction of the main section, a first interval is arranged between every two adjacent first bulges, the first interval penetrates through the first auxiliary section along the extending direction of the first bulges, and a first included angle formed by the far end of the first bulges, far away from the bracket framework, and the axis of the bracket framework in the first extending direction of the axis is an acute angle; and

The second is from the section, the second from the section set up in the other end of main section, the second is from the section include a plurality of second arch, a plurality of the second is protruding to be followed the circumferencial direction interval distribution of main section, two adjacent have the second interval between the second arch, the second interval is followed the bellied extending direction of second runs through the second is from the section, the second is protruding keep away from the distal end of support skeleton with the axis of support skeleton is the acute angle in the second contained angle that axis second extending direction formed.

2. An intranasal drug stent according to claim 1 wherein the axial length L of the main section is in the range 10mm to 20mm; the axial length of the first slave section is 1/12L to 1/2L; the axial length of the second slave section is 1/12L to 1/2L, and the axial length of the second slave section is smaller than that of the first slave section.

3. An intranasal drug stent according to claim 1 wherein the first included angle is in the range 15 ° to 75 °; the second included angle ranges from 15 ° to 75 °.

4. The intranasal drug stent of claim 1 wherein the number of first protrusions N1 is 4.ltoreq.n1.ltoreq.15; the number N2 of the second bulges is more than or equal to 4 and less than or equal to 15, and N2 is more than or equal to 15.

5. An intranasal drug stent according to claim 1 wherein the membrane layer has a plurality of microscale apertures formed therein for attaching drugs to form a drug layer.

6. An intranasal drug stent according to claim 1 wherein the maximum diameter of the stent scaffold is in the range 20mm to 50mm.

7. The intranasal drug stent of claim 1 wherein the first protrusion extends in a straight line or curve from a junction with the stent scaffold to a distal end distal from the stent scaffold.

8. An intranasal drug stent according to any of claims 1 to 7 wherein the stent scaffold is composed of one or more of the following polymers: polylactic acid, L-polylactic acid, polylactic acid-glycolic acid copolymer, polycaprolactone, polyurethane, polyglycerol sebacate, polybutylene succinate, polyethylene glycol-polylactic acid block copolymer, polyethylene glycol-polylactic acid-glycolic acid triblock copolymer; and/or

9. An intranasal pharmaceutical stent according to any one of claims 1 to 7 wherein the membrane layer is affixed to the stent scaffold by spraying, electrospinning or gluing; and/or

The drug layer is attached to the film layer by spray coating or dip coating.