Multi-component medical negative pressure drainage polyurethane sponge and preparation method thereof

Abstract

The invention discloses a multi-component medical negative pressure drainage polyurethane sponge and a preparation method thereof.The polyurethane sponge is formed by foaming a component A and a component B in situ through a one-step method, the component A is composed of, by weight, 100 parts of polyether polyol, 0.5-1.5 parts of a catalyst, 1-2.5 parts of an organosilicon foam stabilizer and 2.5-4.5 parts of water, and the component B is composed of, by weight, 100 parts of polyether polyol, 0.5-1.5 parts of a catalyst, 1-2.5 parts of an organosilicon foam stabilizer and 2.5-4.5 parts of water; the component B is prepared from 30 to 50 parts of toluene diisocynate. A one-step method is adopted for in-situ foaming formation, so that reaction among the components before use is avoided, and the raw materials are still liquid before being sprayed out; the prepared polyurethane sponge is perfectly attached to the wound surface of a patient, and the adaptability and the treatment effect are improved.

Description

Technical Field

[0001] This application relates to the technical field of medical negative pressure sponges, and particularly to a multi-component medical negative pressure drainage polyurethane sponge and a preparation method thereof. Background Art

[0002] Negative pressure drainage technology refers to using a medical polyvinyl alcohol dressing or polyurethane sponge (VSD dressing) with a drainage tube to cover or fill the wound surface of skin and soft tissue defects, then sealing it with a biological semi-permeable membrane to form a closed space, and finally connecting the drainage tube to a negative pressure drainage device to absorb and transport the exudate and blood around the wound to the negative pressure drainage device. This can effectively control wound exudate, reduce wound infection, and accelerate wound healing. Currently, the more commonly used one is the negative pressure drainage polyurethane sponge, which is mainly used for wounds with more exudate. The polyurethane sponge has a unique porous structure, a high porosity rate, and excellent drainage effect.

[0003] Currently, the commonly used polyurethane materials in clinics are all prefabricated products, which are processed into specific sizes according to standardized processes in factories, usually square or circular. Since the wound surfaces of patients are mostly irregular in shape, different in size, and vary in depth, it is difficult for prefabricated products to match the wound surfaces during clinical treatment. Medical staff often use manual methods to simply trim according to the shape of the patient's wound surface to try to meet the treatment needs as much as possible. However, even so, the polyurethane sponge trimmed manually still cannot fit well with the patient's wound surface. There are more or less gaps between the polyurethane sponge and the wound surface, or some parts protrude to cause compression of the wound surface, thus affecting the treatment effect. Therefore, traditional polyurethane sponges cannot meet the personalized needs of patients and may bring the following problems during clinical application:

[0004] ① Incompatibility with the wound surface: The factory prefabricated sponge is in a regular shape and cannot meet the personalized needs of patients. Even after clinical trimming, it still cannot be precisely matched with the patient's wound surface, thus affecting the treatment effect.

[0005] ② Increasing the risk of infection: Clinically trimming the polyurethane sponge increases the exposure time of the polyurethane sponge in the air and its contact with other items, increasing its contamination risk, that is, increasing the infection risk of patients.

[0006] ③ Increasing the waste of time and resources: Trimming the polyurethane sponge increases the workload of medical staff, prolongs the clinical treatment time, and also increases the occupation of medical resources.

[0007] ④ Increasing patient discomfort: If the sponge does not fit tightly with the wound surface or compresses the wound surface, the patient may feel discomfort, affecting their comfort and treatment effect.

[0008] CN113425501A A negative pressure drainage wound dressing and a negative pressure drainage wound dressing device. The negative pressure drainage wound dressing belongs to a single-component polyurethane sponge. That is, all raw materials are placed in a storage tank. After all the raw materials are put into one tank, slow chemical reactions will occur between the raw materials. As time goes by, the raw materials will crosslink to varying degrees, which may cause the raw materials to change from liquid to foamy, resulting in the inability of the raw materials to be ejected from the storage tank or intermittent ejection during use, affecting on-site use.

[0009] In view of this, the present application is proposed. Summary of the Invention

[0010] The object of the present invention is to provide a multi-component medical negative pressure drainage polyurethane sponge and its preparation method. By dividing the raw materials of the polyurethane sponge into two components and filling them separately, the reaction between the raw materials before use is avoided, ensuring that the raw materials remain liquid before ejection, and they will only react with each other during on-site use, without being affected by the passage of time; at the same time, it meets the treatment requirements of complex or irregular wounds, and solves the above problems existing in the prior art.

[0011] To solve the above technical problems, the present invention adopts the following solutions:

[0012] A multi-component medical negative pressure drainage polyurethane sponge, wherein the polyurethane sponge is formed by in-situ foaming of component A and component B by a one-step method. Among them, by weight:

[0013] Component A is composed of 100 parts of polyether polyol, 0.5 - 1.5 parts of catalyst, 1 - 2.5 parts of organosilicon foam stabilizer, and 2.5 - 4.5 parts of water;

[0014] Component B is composed of 30 - 50 parts of toluene diisocyanate.

[0015] In this application, polyether polyol is used as the main reaction raw material for forming the polyurethane sponge; toluene diisocyanate is used as another main reaction raw material; the catalyst is a tin-based or amine-based catalyst, which mainly catalyzes the reaction rate of foaming and gelation; water is used as a chain extender during the reaction and is also the raw material source for producing carbon dioxide bubbles; the organosilicon foam stabilizer stabilizes the foam during the foaming process and controls its size and structure.

[0016] In the selection of component B, the activity of diphenylmethane diisocyanate is higher than that of toluene diisocyanate, and its storage stability is poor, which affects the subsequent in-situ foaming.

[0017] Organotin compounds (such as stannous octoate or dibutyltin dilaurate) have a strong catalytic effect on isocyanates and hydroxyl compounds, while tertiary amine catalysts (triethanolamine or triethylenediamine) are beneficial to the reaction between isocyanates and water.

[0018] Further, in the A component, the polyether polyol has a hydroxyl value of 34 to 41 mg KOH / g and is polyoxypropylene glycol with an average molecular weight of 3000 to 4000.

[0019] Further, in the A component, the catalysts are tin catalysts and amine catalysts, and the mass ratio of the two is 0.4 to 0.7:1.

[0020] Further, the tin catalyst is stannous octoate or dibutyltin dilaurate, and the amine catalyst is triethanolamine or triethylenediamine.

[0021] Further, the toluene diisocyanate is a mixture of 2,4-toluene diisocyanate and 2,6-toluene diisocyanate.

[0022] Further, the mass ratio of 2,4-toluene diisocyanate to 2,6-toluene diisocyanate is 8:2.

[0023] A preparation method of a multi-component medical negative pressure drainage polyurethane sponge includes the following steps:

[0024] S1, Weigh each raw material component by weight to prepare the A component and the B component. After stirring the raw material components in the A component evenly, set it aside for use.

[0025] S2, Respectively introduce the A component and the B component into aerosol can Ⅰ and aerosol can Ⅱ through aerosol can equipment.

[0026] S3, Align aerosol can Ⅰ containing the A component and aerosol can Ⅱ containing the B component and spray them simultaneously onto the wound surface, and integrally foam on the surface of the wound to form a polyurethane sponge.

[0027] Further, in step S1, the A component is stirred at 25 to 50 °C, the stirring rate is greater than 80 r / min, and the stirring time is greater than 1.5 h.

[0028] This application mainly stores the A and B components separately in different aerosol cans to avoid the toluene diisocyanate having too high activity and reacting with other components inside the aerosol can to form a prepolymer with a relatively high viscosity, which is not conducive to spraying from the aerosol nozzle; at the same time, a large amount of heat is released during the reaction, affecting the use of the product and posing a safety hazard. Therefore, the A and B components are stored separately, and the polyurethane sponge is obtained by on-site mixing and foaming during use.

[0029] Further, in the A component, the order of adding each raw material is polyether polyol, catalyst, water, and silicone foam stabilizer. The silicone foam stabilizer is added last, otherwise, due to its poor compatibility with other components and its tendency to form hydrogen bonds with polyether polyol, it will be surrounded by polyether polyol, forming more jelly-like substances, which will affect the spraying of the A component.

[0030] The beneficial effects of the present invention are as follows: In the present invention, the components for preparing the medical negative pressure drainage polyurethane sponge are separately stored in different aerosol cans and formed by in-situ foaming in one step, avoiding the reaction between the components before use, ensuring that the raw materials are still in liquid form before spraying, and only reacting when used on-site, without being affected by the passage of time.

[0031] At the same time, the medical negative pressure drainage polyurethane sponge in this application can be customized according to the specific wound size and shape of the patient. The polyurethane sponge is prepared on-site, which can meet the personalized needs of the patient's wound surface. The prepared polyurethane sponge can meet the treatment needs of complex or irregular wounds compared with the polyurethane sponge produced by traditional methods, without the need to trim the polyurethane sponge, thus reducing the dead space between the sponge and the wound, making the prepared polyurethane sponge perfectly fit the patient's wound surface, improving the adaptability and treatment effect. At the same time, the polyurethane sponge in this application also reduces the probability of contamination, lightens the workload of medical staff, reduces the waiting time for patient treatment, reduces the risk of wound infection, and saves medical costs. Detailed implementation manners

[0032] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the described embodiments of the present invention without creative efforts shall fall within the scope of protection of the present invention.

[0033] In addition, for the sake of clarity and conciseness, descriptions of well-known structures, functions, and configurations may be omitted. Those of ordinary skill in the art will recognize that various changes and modifications can be made to the examples described herein without departing from the spirit and scope of the present disclosure.

[0034] Techniques, methods, and devices known to those of ordinary skill in the relevant fields may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be regarded as part of the authorization specification.

[0035] In all the examples shown and discussed here, any specific values should be construed as merely exemplary, not as limitations. Therefore, other examples of the exemplary embodiments may have different values.

[0036] Example 1

[0037] A preparation method of a multi-component medical negative pressure drainage polyurethane sponge:

[0038] (1) Weigh the components of Group A by parts by weight: 100 parts of polyoxypropylene glycol with a hydroxyl value of 34 mg KOH / g and an average molecular weight of 3000, 0.15 parts of stannous octoate,

[0039] 0.35 parts of triethanolamine, 2.8 parts of water, and 1.2 parts of silicone foam stabilizer are added to the mixing and reaction kettle in sequence, and stirred and mixed evenly at 25 - 50 °C. The stirring rate is 85 r / min, and the stirring time is 1.6 h.

[0040] Group B: 32 parts of a mixture of 2,4-toluene diisocyanate and 2,6-toluene diisocyanate with a mass ratio of 8:2, and mix evenly.

[0041] (2) Introduce the components of Group A and Group B into aerosol cans Ⅰ and Ⅱ respectively through aerosol can equipment to obtain aerosol can Ⅰ filled with the components of Group A and aerosol can Ⅱ filled with the components of Group B for standby.

[0042] (3) After cleaning the wound surface of the patient, using the patient's own wound surface as a mold, open aerosol can Ⅰ and aerosol can Ⅱ simultaneously. The raw materials in the components of Group A and Group B are sprayed out simultaneously. After the sprayed raw materials contact the moisture in the air, they undergo a curing reaction and expand to form a foam on the wound surface, and a polyurethane sponge is obtained after curing.

[0043] The cured sponge fits perfectly with the patient's wound surface. Then connect the suction cup pipeline to make the suction cup stick firmly. Finally, connect to the negative pressure source through the drainage tube for negative pressure drainage treatment.

[0044] Example 2

[0045] A preparation method of a multi-component medical negative pressure drainage polyurethane sponge:

[0046] (1) Weigh the components of Group A by parts by weight: 100 parts of polyoxypropylene glycol with a hydroxyl value of 38 mg KOH / g and an average molecular weight of 3500, 0.2 parts of stannous octoate,

[0047] 0.3 parts of triethanolamine, 3 parts of water, and 1 part of silicone foam stabilizer are added to the mixing and reaction kettle in sequence, and stirred and mixed evenly at 25 - 50 °C. The stirring rate is 90 r / min, and the stirring time is 1.8 h.

[0048] Group B: 37 parts of a mixture of 2,4-toluene diisocyanate and 2,6-toluene diisocyanate with a mass ratio of 8:2, and mix evenly.

[0049] (2) Introduce the components of Group A and Group B into aerosol cans Ⅰ and Ⅱ respectively through aerosol can equipment to obtain aerosol can Ⅰ filled with the components of Group A and aerosol can Ⅱ filled with the components of Group B for standby.

[0050] (3) After cleaning the patient's wound surface, using the patient's own wound surface as a mold, simultaneously open aerosol can I and aerosol can II, and the raw materials in component A and component B are sprayed out at the same time. The sprayed raw materials contact the moisture in the air, undergo a curing reaction, expand on the wound surface to form a foam, and a polyurethane sponge is obtained after curing.

[0051] The cured sponge fits perfectly with the patient's wound surface. Then connect the suction cup pipeline to make the suction cup stick firmly. Finally, connect to the negative pressure source through the drainage tube for negative pressure drainage treatment.

[0052] Example 3

[0053] A preparation method of a multi-component medical negative pressure drainage polyurethane sponge:

[0054] (1) Weigh component A by weight: 100 parts of polyoxypropylene glycol with a hydroxyl value of 41 mg KOH / g and an average molecular weight of 4000, 0.25 part of dibutyltin dilaurate, 0.5 part of triethanolamine, 3.5 parts of water, and 1.5 parts of organosilicon foam stabilizer are added to the mixing and reaction kettle in sequence, and stirred and mixed evenly at 25 - 50 °C. The stirring rate is 90 r / min, and the stirring time is 2 h.

[0055] Component B: 45 parts of a mixture of 2,4-toluene diisocyanate and 2,6-toluene diisocyanate with a mass ratio of 8:2, and mixed evenly.

[0056] (2) Respectively introduce component A and component B into aerosol can I and aerosol can II through aerosol can equipment to obtain aerosol can I filled with component A and aerosol can II filled with component B, for later use.

[0057] (3) After cleaning the patient's wound surface, using the patient's own wound surface as a mold, simultaneously open aerosol can I and aerosol can II, and the raw materials in component A and component B are sprayed out at the same time. The sprayed raw materials contact the moisture in the air, undergo a curing reaction, expand on the wound surface to form a foam, and a polyurethane sponge is obtained after curing.

[0058] The cured sponge fits perfectly with the patient's wound surface. Then connect the suction cup pipeline to make the suction cup stick firmly. Finally, connect to the negative pressure source through the drainage tube for negative pressure drainage treatment.

[0059] Comparative Example 1

[0060] The prefabricated negative pressure drainage polyurethane sponge prepared by the traditional process needs to be cut according to the size of the wound surface.

[0061] Comparative Example 2

[0062] The A component and the B component in Example 1 are mixed evenly and then introduced into the same aerosol can through an aerosol can device, and the wound surface of the patient is sprayed with the material through a nozzle to form a polyurethane sponge.

[0063] Table 1 Comparison of performance data of the in-situ foaming polyurethane sponge prepared in Example 1 of this application and the polyurethane sponges of Comparative Examples 1-2

[0064]

[0065] Note: Compared with Comparative Example 2, *P<0.05

[0066] As can be seen from Table 1, there is no significant difference in the performance of the polyurethane sponge obtained by in-situ foaming in Example 1 of this application compared with the prefabricated negative pressure drainage polyurethane sponge in Comparative Example 1. This fully shows that the polyurethane sponge in this application can meet the requirements of clinical applications, and can be customized according to the specific wound size and shape of the patient. The polyurethane sponge is prepared on-site, which can meet the personalized needs of the patient's wound surface, without manual cutting, so that the polyurethane sponge can be completely fitted to the wound, providing better sealing and negative pressure conduction effects to improve the clinical treatment effect.

[0067] At the same time, in Comparative Example 2, after mixing the raw material components and placing them in the same aerosol can, during the on-site spraying process, there is a pause in the material spraying, which takes a long time and the foam uniformity is poor. The polyurethane sponge formed after spraying is tested, and the performance such as compression deformation, tensile strength, and elongation at break of the polyurethane sponge in Comparative Example 2 is significantly lower than that in Example 1 and Comparative Example 1; although the indexes such as density, water absorption ratio, and average pore size have no significant difference compared with Example 1 and Comparative Example 1, their dispersion is significantly greater than that in Example 1 and Comparative Example 1. This further verifies the uniformity problem of the polyurethane sponge in Comparative Example 2.

[0068] The above is only a preferred embodiment of the present invention, and it is not intended to limit the present invention in any form. Although the present invention has been disclosed above with a preferred embodiment, it is not intended to limit the present invention. Any person skilled in the art can make some changes or modifications to the above-disclosed technical content to make equivalent embodiments with equivalent changes, but as long as it does not depart from the technical solution of the present invention, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention still belong to the scope of the technical solution of the present invention.

Claims

1. A multi-component medical negative pressure drainage polyurethane sponge, characterized in that: The polyurethane sponge is formed by in-situ foaming of component A and component B using a one-step method, wherein, by weight: Component A consists of 100 parts of polyether polyol, 0.5-1.5 parts of catalyst, 1-2.5 parts of organosilicon foam stabilizer, and 2.5-4.5 parts of water; Component B consists of 30-50 parts of toluene diisocyanate.

2. A multi-component medical negative pressure drainage polyurethane sponge according to claim 1, characterized in that: In the component A, the polyether polyol is polyoxypropylene glycol with a hydroxyl value of 34 to 41 mg KOH / g and an average molecular weight of 3000 to 4000.

3. The multi-component medical negative pressure drainage polyurethane sponge according to claim 1, characterized in that: In the component A, the catalyst is a tin catalyst and an amine catalyst, and the mass ratio of the two is 0.4-0.7:

1.

4. A multi-component medical negative pressure drainage polyurethane sponge according to claim 3, characterized in that: The tin catalyst is stannous octoate or dibutyltin dilaurate, and the amine catalyst is triethanolamine or triethylenediamine.

5. The multi-component medical negative pressure drainage polyurethane sponge according to claim 3, characterized in that: The toluene diisocyanate is a mixture of 2,4-toluene diisocyanate and 2,6-toluene diisocyanate.

6. The multi-component medical negative pressure drainage polyurethane sponge according to claim 5, characterized in that: The mass ratio of the 2,4-toluene diisocyanate to the 2,6-toluene diisocyanate is 8:

2.

7. A method for preparing a multi-component medical negative pressure drainage polyurethane sponge, characterized in that: The following steps are involved: S1, weighing each raw material component according to weight to prepare component A and component B, and stirring each raw material component in component A evenly for standby use; S2, introducing component A and component B into aerosol tank I and aerosol tank II respectively through the aerosol tank equipment; S3, aiming the aerosol can I containing component A and the aerosol can II containing component B at the wound surface and spraying them simultaneously, and foaming them integrally on the surface of the wound surface to form a polyurethane sponge.

8. The method for preparing a multi-component medical negative pressure drainage polyurethane sponge according to claim 7, characterized in that: In step S1, the component A is stirred at 25-50° C., with a stirring rate greater than 80 r / min and a stirring time greater than 1.5 h.

9. The method for preparing a multi-component medical negative pressure drainage polyurethane sponge according to claim 7, characterized in that: The raw materials of component A are added in the order of polyether polyol, catalyst, water and organosilicon foam stabilizer.

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