CN115671516A - sinus stent - Google Patents

Abstract

The present invention provides a sinus stent, comprising a body part and a first end connected to the body part, the body part is provided with a first drug, the first end is provided with a second drug, and the first end part is provided with a second drug. The first medicine and the second medicine are medicines for different symptoms. The sinus stent is provided with different drugs on the body part and the first end part, and the first drug and the second drug on the sinus stent are released at the same time, so that multiple drug effects can be exerted at the same time, and it is used to treat different symptoms of patients after sinus endoscopic surgery. , so as to solve the different symptoms after sinus surgery and achieve better postoperative sinus results.

Description

sinus stent

technical field

The invention belongs to the technical field of medical devices, and more specifically relates to a sinus stent.

Background technique

At present, functional endoscopic sinus surgery (FESS) is generally used to treat sinusitis or allergic rhinitis. There are also risks of mucosal inflammation, edema, and postoperative sinus adhesions after FESS. Therefore, it is necessary to place a sinus stent in the sinus area after FESS surgery. On the one hand, the sinus stent keeps the middle nasal passage open through its mechanical support, avoiding the adhesion between the middle turbinate and the lateral wall of the nasal cavity, which facilitates the opening of the sinus ostium; Hyperplasia, so patients can avoid or reduce oral medication use during implantation.

Existing sinus stents only have anti-inflammatory drugs on the stent, which cannot solve other possible symptoms of patients after FESS, and there are many problems such as small drug loading, uncontrollable drug release, and poor therapeutic effect.

Contents of the invention

The purpose of the embodiments of the present invention is to provide a sinus stent to solve one or more problems in the prior art.

To achieve the above object, an embodiment of the present invention provides a sinus stent, comprising a body part and a first end connected to the body part,

The body part is provided with a first medicine, and the first end is provided with a second medicine, and the first medicine and the second medicine are medicines for different symptoms.

In one embodiment, the first drug is an anti-inflammatory drug, and the second drug is a decongestant drug or an analgesic drug.

In one embodiment, the first drug is a glucocorticoid, and the second drug is aspirin or paracetamol.

In one embodiment, both the first drug and the second drug are sustained-release preparations, and the release rate of the second drug is greater than that of the first drug.

In one embodiment, the body portion includes a first grid support with a plurality of first support units, the first end portion includes a second grid support with a plurality of second support units, and the second The support unit has a head end connected to the first support unit and an end far away from the first support unit.

In one embodiment, the first drug is coated on the first support unit, and/or the second drug is coated on the second support unit.

In an embodiment, the first supporting unit has a plurality of first drug-loading grooves, and the first drug is arranged in the first drug-loading grooves.

In one embodiment, the end of the second support unit has a first arc structure, and the first arc structure has a plurality of second drug-loading grooves, and the second drug-loading grooves are provided with the Second drug.

In one embodiment, the extension direction of at least part of the second drug-loading groove is perpendicular to the plane where the first arc-shaped structure is located.

In one embodiment, the head end of the second support unit includes a first rod, a second rod, a third rod and a fourth rod, and the first end of the first rod is connected to the first rod. The first ends of the two rods are connected, the second end of the second rod is connected with the first end of the third rod, and the second end of the third rod is connected with the fourth rod. The first end is connected, one end of the first arc-shaped structure is connected to the second end of the first rod, and the other end of the first arc-shaped structure is connected to the second end of the fourth rod.

In one embodiment, it also includes a second end connected to the body part, the first end and the second end are placed on both sides of the body part in the axial direction, and the second end A third drug is provided.

In one embodiment, the third drug is a drug for anti-inflammation, decongestion or pain relief.

In one embodiment, the body portion includes a first grid support with a plurality of first support units, the second end portion includes a third grid support with a plurality of third support units, and the third The support unit has a head end connected to the first support unit and an end far away from the first support unit.

In one embodiment, the third drug is coated on the third supporting unit.

In one embodiment, the end of the third supporting unit has a second arc structure, and the second arc structure has a plurality of third drug-loading grooves, and the third drug-loading grooves are provided with the A third drug or a second drug.

The sinus stent provided by the embodiment of the present invention includes a body part and a first end connected to the body part, the body part is provided with a first drug, and the first end is provided with a second drug, and the first drug and the second drug are Drugs for different symptoms, the sinus stent is provided with different drugs on the body part and the first end part, and the first drug and the second drug on the sinus stent are released, so that multiple drug effects can be exerted, and the solution to the problem of sinus sinus Patients with various symptoms after endoscopic surgery, in order to achieve better postoperative sinus results.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the accompanying drawings that need to be used in the descriptions of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only of the present invention. For some embodiments, those of ordinary skill in the art can also obtain other drawings based on these drawings without any creative effort.

Fig. 1 is a schematic structural view of a sinus stent provided by an embodiment of the present invention;

2 is a schematic diagram of the partial structure of the second support unit of the sinus stent provided by the embodiment of the present invention;

3 is a schematic structural view of the second support unit of the sinus stent provided by the embodiment of the present invention;

Fig. 4 is a schematic structural diagram of the second support unit of the sinus stent provided by the embodiment of the present invention.

Wherein, each reference sign in the figure:

1- body part;

2 - first end;

3 - the second end;

11 - the first support unit;

21 - the second support unit;

22 - the first arc structure;

31-the third support unit;

32-the second arc structure;

211 - the first rod;

212 - the second rod;

213-the third bar;

214-the fourth bar;

221 - the second drug-loading tank.

Detailed ways

In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments It is a part of embodiments of the present invention, but not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

In the description of the present invention, it should be understood that the terms "comprising" and "having" and any variations thereof are intended to cover a non-exclusive inclusion, for example, a process comprising a series of steps or units, A method, system, product or device is not necessarily limited to those steps or elements explicitly listed, but may include other steps or elements not explicitly listed or inherent to the process, method, product or device.

In addition, in this application, unless otherwise clearly specified and limited, the terms "connection", "connection", "fixation", "installation" and so on should be interpreted in a broad sense, such as mechanical connection or electrical connection; It can be a direct connection or an indirect connection through an intermediary, it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly defined, for those of ordinary skill in the art, the It is necessary to understand the specific meanings of the above terms in this application.

It is to be understood that the terms "length", "width", "top", "bottom", "front", "rear", "left", "right", "vertical", "horizontal", etc. refer to The orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, be configured in a specific orientation, and operation, and therefore should not be construed as limiting the invention.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, a feature defined as "first" and "second" may explicitly or implicitly include one or more of these features. It should be understood that in the description of the embodiments of the present invention, unless otherwise specified, "plurality" means two or more. It should be understood that the term "and/or" used herein is only an association relationship describing associated objects, which means that there may be three relationships, for example, A and/or B, which may mean that A exists alone, and A and B exist simultaneously. B, there are three situations of B alone.

The sinus stent provided by the present invention will be described in detail below in conjunction with specific embodiments.

Fig. 1 is a schematic structural diagram of a sinus stent provided by an embodiment of the present invention. Please refer to FIG. 1 , the sinus stent provided by the embodiment of the present invention includes a body part 1 and a first end part 2 connected to the body part 1, and the body part 1 preferably has a tubular structure;

In this embodiment, the body part 1 is provided with a first medicine, and the first end part 2 is provided with a second medicine, and the first medicine and the second medicine are medicines for different symptoms.

After functional endoscopic sinus surgery, there are risks of mucosal inflammation, edema, and sinus re-adhesion. On the one hand, the sinus stent of this embodiment keeps the middle nasal passage open through its mechanical support characteristics, avoids the adhesion between the middle turbinate and the lateral wall of the nasal cavity, and facilitates the opening of the sinus ostium; Inhibit and alleviate various postoperative symptoms, and patients can avoid or reduce the use of oral drugs during sinus stent implantation.

Due to the particularity of sinusitis, with the prolongation of postoperative time, the existence of inflammation may cause polyps to grow slowly, and continuous anti-inflammation becomes the top priority after surgery. Existing sinus stents are generally simply provided with glucocorticoid drugs on the stent to ensure timely and continuous anti-inflammation after surgery. The inventors found that after FESS, if only the body part 1 is loaded with glucocorticoid drugs, all postoperative symptoms cannot be solved, and there are problems such as small drug loading of glucocorticoid drugs, uncontrollable release, and poor drug efficacy.

Therefore, the sinus stent provided by the embodiment of the present invention includes a body portion and a first end connected to the body portion, the body portion is provided with a first medicine, the first end is provided with a second medicine, the first medicine and the second Medicines are medicines used for different symptoms. The sinus stent sets different drugs on the body part and the end part, releases the first drug and the second drug, makes multiple drug effects, solves different postoperative symptoms of patients, and can also control the release of drugs to improve the therapeutic effect of drugs , to achieve better sinus postoperative results.

In one embodiment, the first drug is an anti-inflammatory drug, and the second drug is a decongestant drug or an analgesic drug.

For example, the inventors found that after FESS, there will be pain for a short period of time. Exemplarily, the first drug is a glucocorticoid, and the second drug is aspirin or paracetamol. The glucocorticoid drug of this embodiment can anti-inflammation after sinus surgery, and aspirin or paracetamol is a drug with analgesic effect, which can relieve postoperative pain.

For another example, the inventors found that after FESS, if there is fluid such as nasal mucus in the nasal cavity, the first drug will be flushed to accelerate the release of the first drug, so that the drug can be completely released within an unexpected time, even within a day. The drugs commonly used to suppress nasal discharge, such as sympathomimetic amines and isopyrazoles, more specifically, ephedrine, pseudoephedrine, oxymetazoline or tetrahydrozoline, are decongestants. Its main function is to shrink the nasal mucosa, and it has a certain effect on the relief of nasal obstruction in chronic simple rhinitis, chronic sinusitis, and allergic rhinitis. However, this type of drug causes nasal mucosal vasoconstriction temporarily, and rebound vasodilation will occur after a period of contraction, making the symptoms of nasal congestion more serious than before. Long-term use can cause nasal mucosal damage, resulting in drug resistance and drug dependence. Sex, eventually leading to hypertrophic rhinitis or atrophic rhinitis. Therefore, decongestants should not be mixed with glucocorticoid drugs. Exemplarily, the decongestant is used as the second drug, loaded on the first end 2, when the sinus stent is placed into the human body, the first end 2 is closer to the sinus mucosa than the body part 1, so that the decongestant Congestants can act on the mucous membrane of the sinuses faster, inhibit the production of nasal mucus and other fluids, and then ensure the effective release of glucocorticoids.

Further, both the first drug and the second drug are sustained-release preparations, and the release rate of the second drug is greater than that of the first drug. The sustained-release preparation of this embodiment refers to a preparation that releases the drug slowly and at a non-constant rate as required. Compared with the corresponding common preparation, the dosing frequency is reduced, and the patient's compliance can be significantly increased or the side effects of the drug can be reduced. In this embodiment, by placing the first drug and the second drug with different release rates, the peak time of the drug concentration in the blood is different. For example, the release rate of the second drug decongestant is greater than the release rate of the first drug glucocorticoid. A better drug treatment effect can be achieved.

In a specific embodiment, the body part 1 includes a grid support with a plurality of first supporting units 11 . The first end portion 2 is located at one end of the body portion 1 in the axial direction. The first end portion 2 includes a second grid support with a plurality of second support units 21, and the second support unit 21 has a head end connected to the first support unit 11 and a distance away from the first support unit. End of Unit 11. The body part 1 preferably has a tubular structure.

In this embodiment, optionally, the first drug is coated on the first supporting unit 11 , and/or the second drug is coated on the second supporting unit 21 . In this embodiment, there is no particular limitation on the specific drug loading method of the main body part 1 , such as spray coating, dip coating, electrophoretic deposition, etc., to coat the drug on the first supporting unit 11 . Likewise, in this embodiment, there is no particular limitation on the specific drug-loading method of the first end portion 2 , for example, spray coating, dip coating, electrophoretic deposition and other methods are used to coat the drug on the second supporting unit 21 .

Optionally, in this embodiment, a plurality of first drug-loading grooves may also be provided on the first supporting unit 11, and the first drug is arranged in the first drug-loading grooves.

Fig. 2 is a schematic diagram of the partial structure of the second support unit of the sinus stent provided by the embodiment of the present invention. Please refer to Figure 1 and Figure 2, further, the end of the second support unit 21 in this embodiment has a first arc structure 22, at least part of the first arc structure 22 has a plurality of second drug-loaded Groove 221, the second medicine is set in the second drug-loading groove 221. In this embodiment, by setting the second drug-loading groove 221 on the first arc-shaped structure 22, the drug-loading space is increased, and the drug forms a thicker drug film at the second drug-loading groove 221, which can play the role of drug storage .

Preferably, the extension direction of at least part of the second drug-loading groove 221 is perpendicular to the plane where the first arc-shaped structure 22 is located. More preferably, the first arc-shaped structure 22 includes an inner side facing the body part 1 and an outer side away from the body part 1, at least part of the first drug-loading groove 22 is disposed on the inner side. The second drug-loading groove 221 of this embodiment is a gap provided on the first arc-shaped structure 22, and the extension direction of the second drug-loading groove 221 is perpendicular to the plane where the first arc-shaped structure 22 is located, which is convenient for bending during the preparation of the sinus stent , reducing the bending resistance during the preparation process.

In a specific embodiment of the present invention, the body part 1 of the sinus support includes a plurality of rows of first support units 11 arranged in the axial direction to form a first grid support, and the support of each row of first support units 11 is composed of a plurality of first support units. A supporting unit 11 is arranged and formed along the circumferential direction. In this embodiment, the body part 1 includes a row of first support units 11 , and the bracket of a row of first support units 11 includes 14 first support units 11 . The first support unit 11 in this embodiment is rhombus-shaped, that is, the first support unit 11 is formed by connecting four rods one by one. In other embodiments, the body part 1 may include multiple rows of first support units 11 , such as two rows, three rows, four rows. The number of the first supporting units 11 contained in the bracket of each row of the first supporting units 11 may be 3-20. Too few first support units 11 will lead to insufficient support of the sinus stent, and too many first support units 11 will cause nasal mucus to hang on the stent of the first support unit 11 after the sinus stent is implanted in the nasal cavity, affecting the medicine freed. The shape of the first supporting unit 11 can also be other shapes, such as triangle or hexagon.

Fig. 3 is a schematic structural view of the second support unit of the sinus stent provided by the embodiment of the present invention. Referring to Fig. 3, in a specific embodiment, the first end of the second support unit 21 of the sinus support includes a first rod 211, a second rod 212, a third rod 213 and a fourth rod 214, the The second end of the first rod 211 is connected to the first end of the second rod 212, the second end of the second rod 212 is connected to the first end of the third rod 213, the The second end of the third rod 213 is connected to the first end of the fourth rod 214, the first end of the first rod 211 and the second end of the fourth rod 214 form an open end, The shapes of the first rod 211 , the second rod 212 , the third rod 213 and the fourth rod 214 are roughly rhombus. As an example but not a limitation, the second end of the fourth rod 214 and the first end of the first rod 1221 form an open end after being staggered, and the second end of the fourth rod 214 and the first end of the first rod The second end of 211 continues to extend after being staggered, the first end of the first arc structure 22 is connected with the second end of the fourth bar 214, the second end of the first arc structure 22 is connected with the first bar 211 The first end is connected. FIG. 4 is a schematic structural view of the second support unit of the sinus support provided by the embodiment of the present invention. Please refer to FIG. The first end of piece 211 is not connected anywhere. The first end of the first arc structure 22 is connected to the first end of the first rod 211 , and the second end of the first arc structure 22 is connected to the second end of the fourth rod 214 .

In addition, it should be noted that in this embodiment, the shapes of the first rod 211 , the second rod 212 , the third rod 213 and the fourth rod 214 are roughly diamond-shaped. The shape formed by the two rods 212, the third rod 213 and the fourth rod 214 may not be a rhombus in the strict sense, and the angle formed between the two rods may be smaller than the angle formed between the two opposite rods. Large or small within a certain range. For example, in the embodiment shown in FIG. 3 , the angle between the first rod 211 and the fourth rod 214 is smaller than the angle between the second rod 213 and the third rod 214 .

In a specific embodiment, the sinus support further includes a second end 3 connected to the body part 1, and the first end 2 and the second end 3 are respectively located in the axial direction of the body part 1. On both sides, the second end portion 3 is provided with a third drug. The medicine provided at the second end 3 of this embodiment can be the same as the medicine on the body part, for example, the medicine for anti-inflammation, or it can be the same as the medicine at the first end 2, for example, the medicine for decongestion or Pain relieving medicines, or different medicines from the main body part 1 and the first end part 2 parts.

Further, the second end part 3 includes a third grid support with a plurality of third support units 31, and the third support units 31 have a head end connected to the first support unit 11 and a distance away from the end of the first support unit 11 . In this embodiment, there is no special limitation on the shape of the third supporting unit 31 . The shape of the third supporting unit 31 in this embodiment may be the same as or different from that of the second supporting unit 21 .

Optionally, the third drug is coated on the third supporting unit 31 .

Optionally, the end of the third support unit 3 has a second arc-shaped structure 32, and the second arc-shaped structure 32 has a plurality of third drug-loading grooves, and the third drug-loading grooves are provided with Describe the third drug.

In this embodiment, the first end portion 2 and the second end portion 3 are located on two sides of the body part 1 in the axial direction. The shape of the second support unit 21 of the first end portion 2 and the shape of the third support unit 31 of the second end portion 3 may be the same or different.

Exemplarily, the body part 1 of this embodiment is provided with a first drug, the first drug is a glucocorticoid drug, and the body part 1 is provided with the first drug to ensure timely and continuous anti-inflammation after surgery. In this embodiment, there is no particular limitation on the specific drug loading method of the body part 1 . For example, spray coating, dip coating, electrophoretic deposition and other methods are used. In this embodiment, the second end 3 connected to the body part 1 is provided with a glucocorticoid drug, and the first end 2 connected to the body part 1 is provided with a decongestant. The inventors found that because the drugs loaded on the sinus stent body are in direct contact with the nasal environment, some drugs are washed away with the nasal fluid before they can take effect, and the anti-inflammatory effect is not well controlled, especially if there is no drug supplement in the acute stage of surgery. It may cause polyps to grow out slowly in the later stage. In this embodiment, in order to alleviate the above-mentioned problems such as untimely release of glucocorticoid drugs in the acute stage of surgery, the glucocorticoid drugs carried by the second end 3 can serve as a drug reserve to play a role in the acute stage of surgery.

The sinus stent of this embodiment includes a body part, a first end part and a second end part respectively connected to two ends of the body part, the body part is provided with a first drug, the first end part is provided with a second drug, and the second end part The patient is equipped with a third drug, and by setting different drugs on the body part, the first end and the second end, multiple drug effects can be exerted, and various postoperative symptoms of patients can be solved, drug loading can be increased, and better sinus surgery can be achieved. After Effects.

The sinus stent in the above embodiment can be made of titanium alloy material, for example, a titanium alloy rod is prepared by laser cutting; the sinus stent in this embodiment can also be made of a filament, for example, the filament is prepared by weaving. The filaments can be biodegradable materials such as PPDO (polydioxanone), poly(L-lactide-co-D-lactide), poly(L-lactide-co- -D,L-lactide), poly(D-lactide-co-D,L-lactide), poly(lactide-co-glycolide), poly(lactide-co-ε -caprolactone), poly(glycolide-co-ε-caprolactone), poly(lactide-co-dioxanone), poly(glycolide-co-dioxanone), poly (lactide-co-trimethylene carbonate), poly(glycolide-co-trimethylene carbonate), poly(lactide-co-ethylene carbonate), poly(glycolide-co- - ethylene carbonate), poly(lactide-co-propylene carbonate), poly(glycolide-co-propylene carbonate), PVP (polyvinylpyrrolidone), PVA (polyethylene glycol), starch, Biomolecules (such as fibrin, microprotein, cellulose, collagen, and hyaluronic acid), polyurethane, rayon, rayon, cellulose triacetate, cellulose, acetic acid, cellulose butyrate, cellulose acetate butyrate , cellophane, nitrocellulose, cellulose propionate, cellulose, carboxymethyl cellulose, etc.

The sinus stent provided by the embodiment of the present invention includes a body part and a first end connected to the body part, the body part is provided with a first drug, and the first end is provided with a second drug, and the first drug and the second drug are Medicines used for different symptoms. The sinus stent is provided with different drugs on the body part and the first end part, and the first drug and the second drug on the sinus stent are released, so that multiple drug effects can be exerted, and the treatment of various symptoms after sinus endoscopic surgery can be solved. It can control the release of drugs and improve the therapeutic effect of drugs, so as to achieve better sinus treatment effect.

The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: it can still be applied to the foregoing embodiments The technical solutions described in the examples are modified, or some or all of the technical features are equivalently replaced; and these modifications or replacements do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims (15)

1. A sinus stent characterized by:

comprising a body portion and a first end connected to the body portion;

the body portion is provided with a first medicament, the first end portion is provided with a second medicament, and the first medicament and the second medicament are medicaments for targeting different symptoms.

2. The sinus support of claim 1, wherein: the first drug is a drug for anti-inflammation and the second drug is a drug for decongestion or a drug for analgesia.

3. The sinus support of claim 2, wherein: the first drug is a glucocorticoid and the second drug is aspirin or paracetamol.

4. A sinus support according to any one of claims 1 to 3, wherein: the first medicament and the second medicament are both sustained-release preparations, and the release speed of the second medicament is greater than that of the first medicament.

5. The sinus support of claim 1, wherein: the body portion includes a first lattice support having a plurality of first support elements, and the first end portion includes a second lattice support having a plurality of second support elements, the second support elements having a head end connected to the first support elements and a tail end remote from the first support elements.

6. The sinus support of claim 5, wherein: the first drug is coated on the first support unit, and/or the second drug is coated on the second support unit.

7. The sinus support of claim 5, wherein: the first supporting unit is provided with a plurality of first medicine carrying grooves, and the first medicine carrying grooves are internally provided with first medicines.

8. The sinus support of claim 5, wherein: the tail end of the second supporting unit is provided with a first arc-shaped structure, at least part of the first arc-shaped structure is provided with a plurality of second medicine carrying grooves, and the second medicine carrying grooves are internally provided with second medicines.

9. The sinus support of claim 8, wherein: at least part of the second medicine carrying grooves extend in a direction perpendicular to the plane of the first arc-shaped structure.

10. The sinus support of claim 9, wherein: the head end of the second supporting unit comprises a first rod piece, a second rod piece, a third rod piece and a fourth rod piece, the second end of the first rod piece is connected with the first end of the second rod piece, the second end of the second rod piece is connected with the first end of the third rod piece, the second end of the third rod piece is connected with the first end of the fourth rod piece, one end of the first arc-shaped structure is connected with the first end of the first rod piece, and the other end of the first arc-shaped structure is connected with the second end of the fourth rod piece.

11. The sinus support of claim 1, wherein: the first end part and the second end part are arranged on two sides of the body part in the axial direction, and the second end part is provided with a third medicine.

12. The sinus support of claim 11, wherein: the third medicament is a medicament for anti-inflammatory, decongestant, or analgesic use.

13. The sinus support of claim 11, wherein: the body portion includes a first lattice support having a plurality of first support elements, and the second end portion includes a third lattice support having a plurality of third support elements, the third support elements having a head end connected to the first support elements and a tail end remote from the first support elements.

14. The sinus support of claim 13, wherein: the third drug is coated on the third support unit.

15. The sinus support of claim 13, wherein: the tail end of the third supporting unit is provided with a second arc-shaped structure, the second arc-shaped structure is provided with a plurality of third medicine carrying grooves, and the third medicine carrying grooves are internally provided with third medicines.

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