Self-adhesive sponge for nasal septum perforation repair

Abstract

The utility model relates to a self-adhesive sponge for nasal septum perforation repair, which is used for fixing cartilage at a nasal septum perforation position and 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 one side of the sponge support layer attached to a wound surface, and the anti-sticking layer is arranged on the other side of the sponge support layer attached to the wound surface. And the surface of the adhesion layer is covered with an anti-adhesion layer. Compared with the prior art, the self-adhesive sponge disclosed by the utility model has good mechanical property, good adhesive capacity between the sponge bracket main body and a wound surface, can be firmly attached to a cartilage of a perforated nasal septum and promote mucous membrane healing, and 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] This utility model belongs to the field of medical materials and relates to a self-adhesive sponge for repairing nasal septum perforation. Background Technology

[0002] Nasal septum deviation is a common otolaryngological condition that can cause symptoms such as nasal congestion, nosebleeds, snoring, sinusitis, and headaches. Endoscopic septal deviation correction surgery is the standard surgical method for treating this condition. During the procedure, some complex situations may arise, such as a history of nasal trauma leading to adhesions between the nasal septum cartilage and mucosa, thin mucosa at the nasal septum spinous processes or ridges, a history of nasal septum surgery, or nasal septum compression or invasion by tumors. These conditions can all potentially lead to nasal septum perforation.

[0003] Nasal septal perforation significantly impacts patients' quality of life, potentially causing discomfort such as nasal dryness, abnormal breath sounds, nasal crusting, and hyperventilation. Currently, surgical repair methods for nasal septal perforation mainly include tetragonal septal cartilage repair and mucosal tension-reducing sutures. Tetragonal septal cartilage repair involves placing cartilage between the perforation site and the mucosa to provide support for repair; however, cartilage fixation is difficult, and it is prone to movement, affecting the repair outcome. Mucosal tension-reducing sutures involve making a mucosal incision posterior or superior to the perforation site, reducing tension, and then suturing. However, intranasal suturing is challenging, easily causing mucosal damage and adhesions, and is difficult to suture when the mucosa is already eroded and thin.

[0004] Chinese patent CN215018194U discloses a nasal septum perforation repair device for repairing the nasal septum mucosa, reducing the difficulty of intranasal suturing. However, it is difficult to implement in cases of thick mucosa or large mucosal damage, and it also cannot suture the cartilage. Therefore, developing an absorbable hemostatic material that can fix the cartilage at the perforation site and promote mucosal healing has become an urgent technical problem for those skilled in the art. Utility Model Content

[0005] The purpose of this invention is to overcome the defects of the prior art and provide a self-adhesive sponge for nasal septum perforation repair. The absorbable and adhesive sponge for nasal septum perforation repair can not only achieve hemostasis, fixation of cartilage at the perforation site, and promotion of mucosal healing at the same time, but also has good biocompatibility and intraoperative operability.

[0006] The objective of this utility model can be achieved through the following technical solutions:

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

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

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

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

[0011] Preferably, the sponge scaffold layer is made of type I collagen and bacterial cellulose gel material, which has good biocompatibility and biodegradability, and can effectively promote wound healing.

[0012] Preferably, the adhesive layer uses an absorbable water-based polyurethane adhesive material, which has a strong adhesive effect in humid and fluid environments. Specifically, the adhesive layer uses water-based polyurethane.

[0013] Furthermore, the anti-adhesive layer is made of anti-adhesive paper, preferably a polyester release film, which can effectively prevent the adhesive layer from adhering to other objects when not in use.

[0014] Preferably, the main body of the sponge support is a sheet structure, including one of round, square, trapezoidal, and elliptical shapes, to accommodate nasal septum perforations of different shapes.

[0015] Preferably, the thickness of the sponge scaffold layer is 2-2.5 mm, the thickness of the adhesive layer is 1-1.5 mm, and the thickness of the sponge scaffold body is 3-4 mm, which can provide sufficient support while maintaining good biocompatibility and absorbability.

[0016] A method for preparing a self-adhesive sponge for nasal septum perforation repair includes the following steps:

[0017] S1. Prepare collagen solution;

[0018] S2. Mix the collagen solution prepared in S1 with the bacterial cellulose gel, add a cross-linking agent, and heat in a water bath to obtain a mixed solution;

[0019] S3. The mixed solution in S2 is injected into the mold and freeze-dried in a vacuum freeze dryer to obtain the sponge support layer.

[0020] S4. After mixing the cationic aqueous polyurethane dispersion solution with collagen and crosslinking agent, heat in a water bath, then add the anionic aqueous polyurethane dispersion solution and mix. Immediately inject into the mold in S3, freeze dry in a vacuum freeze dryer to form an adhesion layer on the surface of the sponge support layer.

[0021] S5. Finally, an anti-stick layer is applied to the surface of the adhesive layer, and the mold is removed to obtain the main body of the sponge support.

[0022] Preferably, in S1, the concentration of the collagen solution is 10-15 wt%.

[0023] Preferably, in S2, the mass ratio of collagen to bacterial cellulose gel is 3:1, the water bath heating temperature is 50-80°C, and the water bath heating time is 6-12 hours.

[0024] Preferably, in S2, the crosslinking agent is glutaraldehyde or genipin, the concentration of the crosslinking agent is 0.05-0.2%, and the amount of the crosslinking agent is 1-2% of the sum of the mass of collagen and bacterial cellulose gel.

[0025] Preferably, in S4, the mass ratio of the cationic aqueous polyurethane dispersion, the anionic aqueous polyurethane dispersion, the collagen, and the crosslinking 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.

[0026] Compared with the prior art, the present invention has the following advantages:

[0027] (1) The self-adhesive sponge provided by this utility model has good adhesion to the wound and has suitable mechanical strength. It can be firmly attached to the cartilage of the nasal septum perforation, promote mucosal healing, reduce wound bleeding, and accelerate the recovery process.

[0028] (2) This utility model provides a more effective, safe and convenient nasal septum perforation repair material, which can not only achieve multiple functions of hemostasis, repair and support at the same time, but also has good biocompatibility, degradability and intraoperative operability. It does not require a second surgery to remove it, improves the nasal septum perforation repair effect, reduces the nasal septum perforation rate, improves the patient's quality of life and avoids the need for nasal septum perforation repair surgery again. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the structure of the self-adhesive sponge for nasal septum perforation repair provided by this utility model.

[0030] Figure 2 This is a schematic diagram illustrating the use of the self-adhesive sponge for nasal septum perforation repair provided by this utility model.

[0031] Explanation of markings in the diagram:

[0032] 1-Anti-adhesion layer; 2-Adhesive layer; 3-Sponge support layer; 4-Nasal septum mucosa; 5-Nasal septum cartilage; 6-Nasal septum perforation area. Detailed Implementation

[0033] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. This embodiment is based on the technical solution of the present invention and provides detailed implementation methods and specific operating procedures; however, the scope of protection of the present invention is not limited to the following embodiments.

[0034] Unless otherwise specified, the functional components or structures in the following embodiments or examples are conventional components or structures used in the art to achieve the corresponding functions.

[0035] 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 subject to any special restrictions.

[0036] Example 1

[0037] Please see Figure 1 This embodiment provides a self-adhesive sponge for repairing nasal septum perforation, used to fix the cartilage at the nasal septum perforation site. It includes a sponge support body, which includes a sponge support layer 3, an adhesive layer 2, and an anti-adhesion layer 1 that are sequentially attached. The side of the sponge support layer 3 that is attached to the wound surface is provided with the adhesive layer 2, and the surface of the adhesive layer 2 is covered with the anti-adhesion layer 1.

[0038] In this embodiment, the side of the sponge scaffold layer 3 away from the wound is a smooth surface.

[0039] Specifically, the sponge scaffold layer 3 is a gel scaffold with a porous structure.

[0040] Specifically, the sponge scaffold layer 3 is made of a composite material of collagen and bacterial cellulose, and the collagen is type I collagen.

[0041] Specifically, the adhesive layer 2 uses an absorbable water-based polyurethane adhesive material, specifically water-based polyurethane, which has a strong adhesive effect and can effectively prevent the sponge support body from shifting.

[0042] Specifically, the anti-adhesive layer 1 is made of anti-adhesive paper, which is a polyester release film, to prevent the sponge bracket body from sticking to external objects when not in use.

[0043] Specifically, the main body of the sponge support has a square structure.

[0044] Specifically, the thickness of the sponge support layer 3 is 2mm, the thickness of the adhesive layer 2 is 1mm, and the thickness of the main body of the sponge support is 3mm, which can provide sufficient support.

[0045] Example 2

[0046] This embodiment describes a method for preparing a self-adhesive sponge for repairing nasal septum perforation, comprising the following steps:

[0047] S1. Take type I collagen and add it to 9 mL of pure water. Stir until it is completely dissolved to prepare a collagen solution with a concentration of 10 wt%.

[0048] S2. Mix 9 mL of the collagen solution prepared in S1 with 0.4 g of bacterial cellulose gel (the mass ratio of collagen to bacterial cellulose gel is 3:1), then add 0.106 g of glutaraldehyde for cross-linking, and heat in a 60°C water bath for 6 h to obtain a mixed solution.

[0049] S3. Take 3 mL of the mixed solution from S2 and inject it into the mold (the mold is a square cavity with a side length of 3*5 cm). After freeze-drying at -20℃ for 12 h, the sponge scaffold layer 3 is obtained.

[0050] S4. Heat 2.5 ml of cationic aqueous polyurethane dispersion solution, 5 g of collagen solution and 0.2 g of glutaraldehyde in a 60°C water bath for 2 h. After adding 2.5 ml of anionic aqueous polyurethane dispersion solution and stirring evenly, immediately take 1.5 mL of the above solution and inject it into the mold in S3. Freeze-dry at -20°C for 12 h to form an adhesion layer 2 on the surface of the sponge support layer 3.

[0051] S5. Finally, a polyester release film is applied to the surface of the adhesive layer 2, and the mold is removed to obtain the main body of the sponge support.

[0052] Example 3

[0053] This embodiment describes a method for preparing a self-adhesive sponge for repairing nasal septum perforation, comprising the following steps:

[0054] S1. Take type I collagen, add 9 mL of pure water, stir until completely dissolved, and prepare a collagen solution with a concentration of 15 wt%.

[0055] S2. Mix 9 mL of the collagen solution prepared in S1 with 0.5 g of bacterial cellulose gel (the mass ratio of collagen to bacterial cellulose gel is 3:1), then add 0.106 g of glutaraldehyde for cross-linking, and heat in a 60°C water bath for 6 h to obtain a mixed solution.

[0056] S3. Take 3 mL of the mixed solution from S2 and inject it into the mold (the mold is a square cavity with a side length of 3*5 cm). After freeze-drying at -20℃ for 12 h, the sponge scaffold layer 3 is obtained.

[0057] S4. Heat 2.5 ml of cationic aqueous polyurethane dispersion solution, 5 g of collagen solution and 0.2 g of glutaraldehyde in a 60°C water bath for 2 h. After adding 2.5 ml of anionic aqueous polyurethane dispersion solution and stirring evenly, immediately take 1.5 mL of the above solution and inject it into the mold in S3. Freeze-dry at -20°C for 12 h to form an adhesion layer 2 on the surface of the sponge support layer 3.

[0058] S5. Finally, a polyester release film is applied to the surface of the adhesive layer 2, and the mold is removed to obtain the main body of the sponge support.

[0059] Please see Figure 2 The method of using the absorbable and adhesive sponge for nasal septum perforation repair in this application is as follows:

[0060] (1) First, trim the main body of the sponge support according to the area of ​​the nasal septum perforation area 6. The size of the main body of the sponge support needs to exceed the edge of the perforation by about 5mm.

[0061] (2) After placing the nasal septal cartilage 5 in the nasal septal perforation area 6, remove the release membrane of the sponge support body, completely cover the nasal septal cartilage 5 with the side with the adhesive layer, and press to make the sponge support body fully fit the wound. If necessary, it can be placed on both sides of the nasal septal perforation area 6.

[0062] In summary, the absorbable and adhesive sponge of this application utilizes the cross-linking of anionic and cationic solutions of aqueous polyurethane separators to generate strong adhesion, making it suitable for tissue adhesion in humid environments. This sponge has a high collagen content; the addition of bacterial cellulose as a scaffold structure improves the sponge's mechanical properties. The sponge's components include absorbable aqueous polyurethane solution, bacterial cellulose, and collagen, all exhibiting good biocompatibility and biodegradability. The collagen also possesses hemostatic effects. Clinical studies have demonstrated that the absorbable and adhesive sponge of this invention is safe and effective, allowing for rapid removal of the anti-adhesion layer 1 to repair nasal septum defects. It exhibits good self-adhesion without displacement, deformation, or inversion, effectively fixing the nasal septum cartilage 5 and promoting the healing of the nasal septum mucosa 4, improving the repair effect of nasal septum perforation, reducing the nasal septum perforation rate, improving patients' quality of life, and avoiding the need for repeat nasal septum perforation repair surgery.

[0063] The above description of the embodiments is provided to enable those skilled in the art to understand and use the utility model. It will be apparent to those skilled in the art that various modifications can be easily made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present utility model is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present utility model without departing from its scope should be within the protection scope of the present utility model.

Claims

1. A self-adhesive sponge for repairing nasal septum perforation, used to fix the cartilage at the site of nasal septum perforation, characterized in that, The device includes a sponge scaffold body, which comprises a sponge scaffold layer (3), an adhesive layer (2), and an anti-adhesion layer (1) that are sequentially attached to each other. The side of the sponge scaffold layer (3) that is attached to the wound is provided with an adhesive layer (2), and the surface of the adhesive layer (2) is covered with an anti-adhesion layer (1).

2. The self-adhesive sponge for nasal septum perforation repair according to claim 1, characterized in that, The side of the sponge scaffold layer (3) away from the wound is smooth.

3. The self-adhesive sponge for nasal septum perforation repair according to claim 1, characterized in that, The sponge support layer (3) has a porous structure.

4. The self-adhesive sponge for nasal septum perforation repair according to claim 1, characterized in that, The sponge scaffold layer (3) is a gel scaffold.

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

6. The self-adhesive sponge for nasal septum perforation repair according to claim 1, characterized in that, The anti-stick layer (1) is made of anti-stick paper.

7. The self-adhesive sponge for nasal septum perforation repair according to claim 6, characterized in that, The release paper is a polyester release film.

8. The self-adhesive sponge for nasal septum perforation repair according to claim 1, characterized in that, The sponge support body is a sheet structure, including circular, square, trapezoidal, and elliptical shapes.

9. 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, and the thickness of the adhesive layer (2) is 1 to 1.5 mm.

10. A self-adhesive sponge for repairing nasal septum perforation according to claim 1, characterized in that, The thickness of the sponge support body is 3-4 mm.

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