Self-adhesive sponge for repairing perforation of nasal septum and preparation method of self-adhesive sponge

Abstract

The invention relates to a self-adhesive sponge for nasal septum perforation repair and a preparation method thereof, the self-adhesive sponge for nasal septum perforation repair comprises a sponge support body, the sponge support body comprises a sponge support layer, an adhesive layer and an anti-sticking layer which are sequentially attached, the adhesive layer is arranged on the side, attached to a wound, of the sponge support layer, and the anti-sticking layer is arranged on the side, attached to the wound, of the sponge support layer. And the surface of the adhesion layer is covered with an anti-adhesion layer. Compared with the prior art, the preparation method of the self-adhesive sponge is simple, the sponge stent body has good mechanical performance, the sponge stent body and a wound surface have good adhesive capacity, and the self-adhesive sponge can be firmly attached to the cartilage of a perforated nasal septum and promote mucous membrane healing; in addition, the nasal septum perforation repair material also has good biological safety, degradability and intraoperative operability, the nasal septum perforation repair effect is improved, the nasal septum perforation rate is reduced, and the life quality of a patient is improved.

Description

Technical Field

[0001] The invention belongs to the field of medical materials and relates to a self-adhesive sponge for repairing nasal septum perforation and a preparation method thereof. Background Art

[0002] Nasal septum deviation is a common disease in otolaryngology, which may cause symptoms such as nasal congestion, nose bleeding, snoring at night, sinusitis and headache. Endoscopic correction of nasal septum deviation is the standard surgical method for treating this disease. During the operation, some complex situations may be encountered, such as adhesion of nasal septum cartilage and mucosa caused by previous nasal trauma, thin mucosa at the nasal septum spinous process or ridge, previous history of nasal septum surgery, and compression and invasion of the nasal septum by tumors, all of which may lead to nasal septum perforation.

[0003] Nasal septum perforation has a significant impact on the patient's quality of life and may cause discomfort such as dry nose, abnormal breath sounds, nasal crusting and hyperventilation. At present, the repair methods for nasal septum perforation during surgery mainly include nasal septum quadrilateral cartilage repair and mucosal tension-relief suture. Nasal septum quadrilateral cartilage repair is to place the cartilage between the mucosa at the perforation to provide repair support for the mucosa, but the cartilage is difficult to fix and is easy to move, affecting the repair effect. Mucosal tension-relief suture is to make a mucosal incision behind or above the perforation, and suture after tension relief, but intranasal suture is difficult and can easily cause mucosal damage and adhesion, and it is difficult to suture when the mucosa itself is eroded and weak.

[0004] Chinese patent CN215018194U discloses a nasal septum perforation repairer, which is used to repair the mucosa on the nasal septum, reducing the difficulty of suturing in the nose, but it is difficult to achieve when the mucosa is thick or the mucosa is severely damaged, and it is also impossible to suture the cartilage. Therefore, the development of an absorbable hemostatic material that can fix the cartilage at the perforation and promote mucosal healing has become a technical problem that needs to be solved urgently by technicians in this field. Summary of the invention

[0005] The purpose of the present invention is to overcome the defects of the above-mentioned prior art and to provide a self-adhesive sponge for repairing nasal septum perforation and a preparation method thereof. The self-adhesive sponge for repairing nasal septum perforation can not only achieve hemostasis, fix the cartilage at the perforation, and promote the healing of the mucosa, but also has good biocompatibility and intraoperative operability.

[0006] The purpose of the present invention can be achieved by the following technical solutions:

[0007] On the one hand, the present invention provides a self-adhesive sponge for repairing nasal septum perforation, which is used to fix the cartilage at the nasal septum perforation, including a sponge support body, and the sponge support body includes a sponge support layer, an adhesion layer, and an anti-adhesion layer that are sequentially bonded. The side of the sponge support layer that is bonded to the wound is provided with an adhesion layer, and the surface of the adhesion layer is covered with an anti-adhesion layer.

[0008] Preferably, the side of the sponge support layer away from the wound surface is a smooth surface, which helps to protect the sensitive tissue in the nasal cavity and makes it easier to remove the packing after surgery, reducing the patient's discomfort.

[0009] Preferably, the sponge support layer is a gel support.

[0010] Preferably, the sponge support layer has a porous structure.

[0011] Furthermore, the sponge support layer adopts collagen and bacterial cellulose gel materials.

[0012] Preferably, the collagen is type I collagen, which has good biocompatibility and biodegradability, and can effectively promote wound healing.

[0013] Furthermore, the adhesive layer is made of absorbable water-based polyurethane adhesive material, which has a strong adhesive effect in a wet and fluid environment. Specifically, the adhesive layer is made of water-based polyurethane.

[0014] Furthermore, the anti-sticking layer is made of anti-sticking paper, and the anti-sticking paper is preferably a polyester release film, which can effectively prevent the adhesive layer from adhering to other objects when not in use.

[0015] Preferably, the main body of the sponge support is a sheet structure, including one of a circular, square, trapezoidal, and elliptical shape, so as to adapt to nasal septum perforations of different shapes.

[0016] Preferably, the thickness of the sponge support layer is 2 to 2.5 mm, the thickness of the adhesive layer is 1 to 1.5 mm, and the thickness of the sponge support body is 3 to 4 mm, which can provide sufficient supporting force while maintaining good biocompatibility and absorbency.

[0017] On the other hand, the present invention also provides a method for preparing the self-adhesive sponge for repairing nasal septum perforation as described above, comprising the following steps:

[0018] S1. preparing collagen solution;

[0019] S2, mixing the collagen solution prepared in S1 with the bacterial cellulose gel, adding a cross-linking agent, and heating in a water bath to obtain a mixed solution;

[0020] S3, injecting the mixed solution in S2 into a mold, and freeze-drying it in a vacuum freeze dryer to obtain a sponge scaffold layer;

[0021] S4, mixing the cationic aqueous polyurethane dispersion solution, collagen and a cross-linking agent, heating the mixture in a water bath, adding the anionic aqueous polyurethane dispersion solution, mixing the mixture, and immediately injecting the mixture into the mold in S3, freeze-drying the mixture in a vacuum freeze dryer, and forming an adhesion layer on the surface of the sponge support layer;

[0022] S5. Finally, an anti-sticking layer is applied on the surface of the adhesive layer, and the mold is released to obtain the sponge support body.

[0023] Preferably, in S1, the concentration of the collagen solution is 10-15 wt %.

[0024] Preferably, in S2, the mass ratio of the collagen to the bacterial cellulose gel is 3:1, the water bath heating temperature is 50 to 80° C., and the water bath heating time is 6 to 12 hours.

[0025] Preferably, in S2, the cross-linking agent is glutaraldehyde or genipin, the concentration of the cross-linking agent is 0.05-0.2%, and the amount of the cross-linking agent is 1-2% of the sum of the mass of collagen and bacterial cellulose gel.

[0026] Preferably, in S4, the mass ratio of the cationic waterborne polyurethane dispersion, the anionic waterborne polyurethane dispersion, the collagen and the cross-linking agent is 1:1:2:0.08, the water bath heating temperature is 50-80°C, and the water bath heating time is 1-6h.

[0027] Compared with the prior art, the present invention has the following advantages:

[0028] (1) The self-adhesive sponge provided by the present invention has good adhesion to the wound surface and suitable mechanical strength, and can be firmly attached to the cartilage of the nasal septum perforation, promote mucosal healing, reduce wound bleeding, and accelerate the recovery process.

[0029] (2) The present invention provides a more effective, safe and convenient nasal septum perforation repair material and a preparation method thereof, which can not only achieve the multiple functions of hemostasis, repair and support at the same time, but also has good biosafety, degradability and intraoperative operability. It does not require a second operation to remove it, thereby improving the repair effect of nasal septum perforation, reducing the nasal septum perforation rate, improving the quality of life of patients, and avoiding the need for another nasal septum perforation repair operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 This is a schematic diagram of the structure of the self-adhesive sponge for repairing nasal septum perforation provided by the present invention;

[0031] Figure 2 This is a schematic diagram of the use of the self-adhesive sponge for repairing nasal septum perforation provided by the present invention.

[0032] Description of the markings in the figure:

[0033] 1-anti-adhesion layer; 2-adhesion layer; 3-sponge support layer; 4-nasal septum mucosa; 5-nasal septum cartilage; 6-nasal septum perforation area. DETAILED DESCRIPTION

[0034] The present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. This embodiment is implemented based on the technical solution of the present invention, and provides a detailed implementation method and specific operation process, but the protection scope of the present invention is not limited to the following embodiments.

[0035] In the following implementation manners or examples, unless otherwise specified, functional components or structures are conventional components or conventional structures used in the art to achieve corresponding functions.

[0036] In the following examples, type I collagen, bacterial cellulose gel, cationic aqueous polyurethane dispersion, and anionic aqueous polyurethane dispersion are all commercially available products and are not particularly limited.

[0037] Example 1

[0038] See also Figure 1 The present embodiment provides a self-adhesive sponge for repairing nasal septum perforation, which is used to fix the cartilage at the nasal septum perforation, including a sponge support body, and the sponge support body includes a sponge support layer 3, an adhesion layer 2, and an anti-adhesion layer 1 that are sequentially bonded. The side of the sponge support layer 3 that is bonded to the wound is provided with an adhesion layer 2, and the surface of the adhesion layer 2 is covered with an anti-adhesion layer 1.

[0039] In this embodiment, the side of the sponge support layer 3 away from the wound surface is a smooth surface.

[0040] Specifically, the sponge support layer 3 is a gel support having a porous structure.

[0041] Specifically, the sponge support layer 3 is made of type I collagen and bacterial cellulose gel material. The sponge support layer 3 is used to support the overall structure and plays the role of a skeleton.

[0042] Specifically, the adhesive layer 2 is made of absorbable water-based polyurethane adhesive material, specifically water-based polyurethane, which has a strong adhesion effect and can effectively prevent the sponge support body from shifting.

[0043] Specifically, the anti-sticking layer 1 is made of anti-sticking paper, which is a polyester release film, to prevent the sponge support body from adhering to external objects when not in use.

[0044] Specifically, the sponge support body is a square structure.

[0045] Specifically, the thickness of the sponge support layer 3 is 2 mm, the thickness of the adhesive layer 2 is 1 mm, and the thickness of the sponge support body is 3 mm, which can provide sufficient supporting force.

[0046] Example 2

[0047] The method for preparing a self-adhesive sponge for repairing nasal septum perforation of the present embodiment comprises the following steps:

[0048] S1. Add 9 mL of pure water to type I collagen and stir to completely dissolve it to prepare a collagen solution with a concentration of 10 wt%;

[0049] S2, 9 mL of the collagen solution prepared in S1 was mixed with 0.4 g of bacterial cellulose gel (the mass ratio of collagen to bacterial cellulose gel was 3:1), and then 0.106 g of glutaraldehyde was added for cross-linking, and heated in a water bath at 60° C. for 6 h to obtain a mixed solution;

[0050] S3, taking 3 mL of the mixed solution in S2 and injecting it into a mold (the mold is a square cavity with a side length of 3*5 cm), and freeze-drying it at -20°C for 12 h to obtain a sponge scaffold layer 3;

[0051] S4, 2.5 ml of cationic aqueous polyurethane dispersion solution, 5 g of collagen solution, and 0.2 g of glutaraldehyde were heated in a 60° C. water bath for 2 h, 2.5 ml of anionic aqueous polyurethane dispersion solution was added and stirred evenly, and 1.5 ml of the above solution was immediately injected into the mold in S3, and freeze-dried at -20° C. for 12 h to form an adhesion layer 2 on the surface of the sponge support layer 3;

[0052] S5. Finally, a polyester release film is coated on the surface of the adhesive layer 2, and the mold is released to obtain the sponge support body.

[0053] Example 3

[0054] The method for preparing a self-adhesive sponge for repairing nasal septum perforation of the present embodiment comprises the following steps:

[0055] S1. Take type I collagen, add 9 mL of pure water, stir to completely dissolve it, and prepare a collagen solution with a concentration of 15 wt%;

[0056] S2, 9 mL of the collagen solution prepared in S1 was mixed with 0.5 g of bacterial cellulose gel (the mass ratio of collagen to bacterial cellulose gel was 3:1), and then 0.106 g of glutaraldehyde was added for cross-linking, and heated in a 60° C. water bath for 6 h to obtain a mixed solution;

[0057] S3, taking 3 mL of the mixed solution in S2 and injecting it into a mold (the mold is a square cavity with a side length of 3*5 cm), and freeze-drying it at -20°C for 12 h to obtain a sponge scaffold layer 3;

[0058] S4, 2.5 ml of cationic aqueous polyurethane dispersion solution, 5 g of collagen solution, and 0.2 g of glutaraldehyde were heated in a 60° C. water bath for 2 h, 2.5 ml of anionic aqueous polyurethane dispersion solution was added and stirred evenly, and 1.5 ml of the above solution was immediately injected into the mold in S3, and freeze-dried at -20° C. for 12 h to form an adhesion layer 2 on the surface of the sponge support layer 3;

[0059] S5. Finally, a polyester release film is coated on the surface of the adhesive layer 2, and the mold is released to obtain the sponge support body.

[0060] See also Figure 2 The method of using the self-adhesive sponge for repairing nasal septum perforation in this application is as follows:

[0061] (1) First, the sponge support body is trimmed according to the area of ​​the nasal septum perforation area 6. The size of the sponge support body needs to exceed the perforation edge by about 5 mm.

[0062] (2) After placing the nasal septum cartilage 5 in the nasal septum perforation area 6, tear off the release film of the sponge stent body, completely cover the nasal septum cartilage 5 with the side with the adhesive layer, and press to make the sponge stent body fully fit the wound surface. If necessary, it can be placed on both sides of the nasal septum perforation area 6.

[0063] In summary, the absorbable and adhesive sponge of the present application utilizes aqueous polyurethane separation anion and cation solution cross-linking to produce strong adhesion, and is suitable for tissue adhesion in a wet environment; the sponge has a high collagen content; bacterial cellulose is added as a skeleton structure to improve the mechanical properties of the sponge; the components of the sponge include absorbable aqueous polyurethane solution, bacterial cellulose, and collagen, all of which have good biocompatibility and degradability, and collagen also has a hemostatic effect. Clinical studies have shown that the self-adhesive sponge of the present invention is safe and effective, can quickly remove the anti-adhesive layer 1 to repair the nasal septum defect, has good self-adhesion and will not shift, deform, or hang upside down, can effectively fix the nasal septum cartilage 5 and promote the healing of the nasal septum mucosa 4, improve the repair effect of nasal septum perforation, reduce the nasal septum perforation rate, improve the quality of life of patients, and avoid re-nasal septum perforation repair.

[0064] The above description of the embodiments is to facilitate the understanding and use of the invention by those skilled in the art. It is obvious that those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. A self-adhesive sponge for repairing nasal septum perforation, used for fixing the cartilage at the nasal septum perforation, characterized in that: The invention comprises a sponge support body, wherein the sponge support body comprises a sponge support layer (3), an adhesive layer (2), and an anti-adhesive layer (1) which are bonded in sequence; the side of the sponge support layer (3) which is bonded to the wound is provided with the adhesive layer (2), and the surface of the adhesive layer (2) is covered with the anti-adhesive layer (1).

2. A self-adhesive sponge for repairing nasal septum perforation according to claim 1, characterized in that: The sponge support layer (3) is a gel support.

3. A self-adhesive sponge for repairing nasal septum perforation according to claim 1, characterized in that: The adhesive layer (2) is made of absorbable water-based polyurethane adhesive material.

4. A self-adhesive sponge for repairing nasal septum perforation according to claim 1, characterized in that: The anti-adhesive layer (1) is made of anti-adhesive paper, which is a polyester release film.

5. A self-adhesive sponge for repairing nasal septum perforation according to claim 1, characterized in that: The thickness of the sponge support layer (3) is 2 to 2.5 mm, the thickness of the adhesive layer (2) is 1 to 1.5 mm, and the thickness of the sponge support body is 3 to 4 mm.

6. A method for preparing a self-adhesive sponge for repairing nasal septum perforation according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1. preparing collagen solution; S2, mixing the collagen solution prepared in S1 with the bacterial cellulose gel, adding a cross-linking agent, and heating in a water bath to obtain a mixed solution; S3, injecting the mixed solution in S2 into a mold, and freeze-drying to obtain a sponge scaffold layer (3); S4, mixing the cationic aqueous polyurethane dispersion solution, collagen and a cross-linking agent, heating the mixture in a water bath, adding the anionic aqueous polyurethane dispersion solution, mixing the mixture, and immediately injecting the mixture into the mold in S3, and freeze-drying the mixture to form an adhesion layer (2) on the surface of the sponge support layer (3); S5. Finally, the anti-sticking layer (1) is coated on the surface of the adhesive layer (2), and the mold is released to obtain the sponge support body.

7. The method for preparing a self-adhesive sponge for repairing nasal septum perforation according to claim 6, characterized in that: In S1, the concentration of the collagen solution is 10-15 wt%.

8. The method for preparing a self-adhesive sponge for repairing nasal septum perforation according to claim 6, characterized in that: In S2, the mass ratio of the collagen to the bacterial cellulose gel is 3:1, the water bath heating temperature is 50 to 80° C., and the water bath heating time is 6 to 12 hours.

9. The method for preparing a self-adhesive sponge for repairing nasal septum perforation according to claim 6, characterized in that: In S2, the cross-linking agent is glutaraldehyde or genipin, the concentration of the cross-linking agent is 0.05-0.2%, and the amount of the cross-linking agent is 1-2% of the sum of the mass of collagen and bacterial cellulose gel.

10. The method for preparing a self-adhesive sponge for repairing nasal septum perforation according to claim 6, characterized in that: In S4, the mass ratio of the cationic waterborne polyurethane dispersion, the anionic waterborne polyurethane dispersion, the collagen and the cross-linking agent is 1:1:2:0.08, the water bath heating temperature is 50-80°C, and the water bath heating time is 1-6 hours.

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