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A kind of tissue sealant powder, its preparation process and tissue sealant

A sealing agent and powder technology, applied in the field of biodegradable polymer materials, can solve the problems of inconsistent operation of the push rod, easy formation of thrombus, and blockage of the front end of the applicator, so as to improve the instantaneous liquid absorption ability, avoid related complications, The effect of preventing postoperative adhesions

Active Publication Date: 2021-06-15
北京爱特康医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, before clinical application, most of the wounds need to be wiped dry, and then a liquid sealant is applied; during the preparation of the liquid sealant, there are a large amount of acidic and alkaline physiological diluents, such as uneven mixing or a push rod for pushing out the liquid sealant The operation is inconsistent, and it is easy to cause irritation to the application site of the wound; the front end of the applicator of the liquid sealant is easily blocked by the solidified gel, and the same injection cannot be used multiple times in a short period of time
[0003] At present, clinical hemostatic materials have high water absorption capacity, and the hemostasis is successful within 5 minutes, but after 5 minutes or in the case of moderate, severe or active bleeding, the possibility of secondary bleeding is very high. The main reason is that Hemostatic materials do not have good adhesion to hemostatic tissue wounds. In terms of clinical application, when a large amount of blood, gas, and foam exist at the same time, the existing tissue sealants and hemostatic materials cannot be timely and effective. Although some can achieve a short-term sealing effect, they are prone to thrombosis and cause intraoperative and postoperative complications.
[0004] The buffer solution required by the commercially available sealant requires complex preparation of acid and lye before surgery; longer gelation time causes large body fluid loss; lower activity, shorter shelf life; weak instantaneous liquid absorption ability, etc.

Method used

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  • A kind of tissue sealant powder, its preparation process and tissue sealant
  • A kind of tissue sealant powder, its preparation process and tissue sealant
  • A kind of tissue sealant powder, its preparation process and tissue sealant

Examples

Experimental program
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Effect test

Embodiment 1

[0045] The physical melting method fully mixes PEG-SS (4, 10000Da) and 4 times the quality of PEG-SS super absorbent carboxymethyl starch sodium powder, and through granulation and other processes to obtain tissue sealant powder or hemostatic material, which is applied to animals with severe For bleeding wounds, press for 25 seconds, solidify excess powder with physiological diluent, or rinse with a large amount of physiological diluent to stop bleeding. Physiological diluent is phosphate buffer (pH=7.4);

[0046] The preparation method of phosphate buffer solution with pH=7.4: Weigh 4.005g of sodium chloride, 0.1g of potassium chloride, 1.7907g of disodium hydrogen phosphate dodecahydrate, and 0.135g of potassium dihydrogen phosphate, and place them in a 500mL volumetric flask in turn , and then dissolved to obtain a PBS buffer solution with pH=7.4;

[0047] Tissue sealant powder (powder A + powder B): physiological diluent = 1:3.

Embodiment 2

[0049] The physical melting method fully mixes PEG-SC (2,5000Da) and 4 times the quality of PEG-SC super absorbent carboxymethyl starch sodium powder, and obtains tissue sealant powder through granulation and other processes, which is applied to severe bleeding wounds of animals. Press for 30 seconds to stop bleeding.

Embodiment 3

[0051] PEG-SPA (4, 10000Da) and 6 times the quality of PEG-SPA high water carboxymethyl starch sodium powder are fully mixed by physical melting method, and through granulation and other processes to obtain tissue sealant powder or hemostatic material, which is applied to animals with severe For bleeding wounds, press for 25 seconds, solidify excess powder with physiological diluent, or rinse with a large amount of physiological diluent to stop bleeding. Physiological diluent is phosphate buffer (pH=7.4); tissue sealant powder (powder A+powder B): physiological diluent=1:3.

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Abstract

The present application relates to a tissue sealant powder, a preparation process thereof, and a tissue sealant. The sealant powder includes a first component and a second component, and the first component is an electrophilic raw material, which itself contains an electrophilic functional group , or a compound with an electrophilic functional group supported by physical means; the second component is a plant-derived biological material; the component distribution ratio is as follows: the mass ratio of the first component: the second component is 1:1-10. The preparation method uses a physical melting method and a fluidized bed method to make the super absorbent substances of the first and second components contain active functional groups without any other catalysts, reagents, or change their own chemical properties. The tissue sealant has rapid liquid absorption, high liquid absorption ability, strong adhesion ability, in vivo degradation, mild inflammatory reaction, and can be directly applied to the wound surface.

Description

technical field [0001] The invention belongs to the field of biodegradable polymer materials, in particular to a method for preparing an in-situ cross-linked tissue sealant powder or a hemostatic material that can be directly applied to a wet wound surface and has a strong and rapid liquid absorption capacity . Background technique [0002] At present, before clinical application, most of the wounds need to be wiped dry, and then a liquid sealant is applied; during the preparation of the liquid sealant, there are a large amount of acidic and alkaline physiological diluents, such as uneven mixing or a push rod for pushing out the liquid sealant The operation is inconsistent, and it is easy to cause irritation to the application site of the wound; the front end of the applicator of the liquid sealant is easily blocked by the solidified gel, and the same injection cannot be used multiple times in a short period of time. [0003] At present, clinical hemostatic materials have h...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L24/08A61L24/04A61L24/00
CPCA61L24/001A61L24/0031A61L24/0036A61L24/046A61L24/08A61L2400/04C08L3/08C08L71/02
Inventor 郝卫国
Owner 北京爱特康医疗科技有限公司
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