CN112552661A - Plastic tissue compensation glue and preparation method thereof - Google Patents

Plastic tissue compensation glue and preparation method thereof Download PDF

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Publication number
CN112552661A
CN112552661A CN202011431926.8A CN202011431926A CN112552661A CN 112552661 A CN112552661 A CN 112552661A CN 202011431926 A CN202011431926 A CN 202011431926A CN 112552661 A CN112552661 A CN 112552661A
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parts
tissue compensation
glue
compensation glue
plastic tissue
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CN112552661B (en
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邱锡波
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Klarity Medical & Equipment Gz Co ltd
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Klarity Medical & Equipment Gz Co ltd
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    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • C08L67/04Polyesters derived from hydroxycarboxylic acids, e.g. lactones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L91/00Compositions of oils, fats or waxes; Compositions of derivatives thereof
    • C08L91/06Waxes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N2005/1092Details
    • A61N2005/1096Elements inserted into the radiation path placed on the patient, e.g. bags, bolus, compensators
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2205/00Polymer mixtures characterised by other features
    • C08L2205/03Polymer mixtures characterised by other features containing three or more polymers in a blend
    • C08L2205/035Polymer mixtures characterised by other features containing three or more polymers in a blend containing four or more polymers in a blend

Abstract

The invention discloses a plastic tissue compensation glue and a preparation method thereof, belonging to the technical field of medical instruments. The plastic tissue compensation glue comprises the following preparation raw materials in parts by weight: 7-15 parts of polyethylene glycol, 25-45 parts of polycaprolactone, 8-10 parts of a compatilizer and 40-50 parts of a density regulator. The tissue compensation glue constructed by the invention can be shaped at the temperature of the body surface of a human body, the maximum clearance between the tissue compensation glue and the body surface of the human body is between 0.33 and 0.44cm and is far lower than the maximum clearance between the tissue compensation glue and the body surface, which is commonly used in the market, by 1.12 cm. This plasticity tissue compensation glue is convenient more carries out the adaptation to the profile of target area, avoids having great cavity between compensation glue and body surface, influences the problem of radiotherapy effect.

Description

Plastic tissue compensation glue and preparation method thereof
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a plastic tissue compensation glue and a preparation method thereof.
Background
Radiation therapy is an important approach to cancer treatment. Due to the existence of "built-up area effect" of radiotherapy radiation, when radiotherapy is performed on superficial tumors, it is often difficult to ensure the maximization of the radiation dose of a focus area, and for this reason, tissue compensation glue is usually adopted clinically to increase the built-up depth of the skin surface so as to increase the dose of a target area. The materials commonly used as tissue compensation glue at present comprise a thin film plastic water bag, paraffin, low density polyethylene, vaseline, special silica gel and the like. However, most of the materials have poor fitting performance, and air gaps often exist between the materials and the body surface outline, so that a secondary 'build-up effect' is caused, and the problem of skin damage is aggravated; especially, when the body type curved surface, the postoperative scar and the tumor of a patient are irregular in appearance, a large cavity is often formed between the tissue compensation glue and the body surface, and the radiotherapy effect is seriously influenced. For this clinical trial, a tissue compensator is customized for a patient by using a 3D printing technology, however, the 3D printing method has a long manufacturing period and high cost, and is difficult for a general patient to bear, and the application is limited to a certain extent.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a plastic tissue compensation glue and a preparation method thereof. The plastic tissue compensation glue disclosed by the invention has plasticity at the body surface temperature of a human body, can better adapt to the contour of a target area, avoids the problem that the compensation glue and the body surface have a cavity, and is convenient to use and low in cost.
In order to achieve the purpose, the invention adopts the technical scheme that: the plastic tissue compensation glue comprises the following preparation raw materials in parts by weight: 7-15 parts of polyethylene glycol, 25-45 parts of polycaprolactone, 8-10 parts of a compatilizer and 40-50 parts of a density regulator.
The plastic tissue compensation glue prepared by the raw material formula in the limited range has the best effect, has smaller maximum clearance with the body surface compared with the commercially available general tissue compensation glue, can be better shaped on the body surface contour of a patient, and reduces the influence of the secondary dose build-up effect on the radiotherapy effect.
In a preferred embodiment of the present invention, the polyethylene glycol has a molecular weight of 750 to 1050.
The polyethylene glycol has hydrophilicity and strong skin affinity, and the molding temperature of the polyethylene glycol with the molecular weight of 750-1050 used in the invention is 40 ℃, and the plasticity is optimal.
In a preferred embodiment of the invention, the molecular weight of the polycaprolactone is 2000-3000. The polycaprolactone is soft in texture and has great extensibility.
As a preferred embodiment of the present invention, the compatibilizer is povidone K30.
The povidone K30 can promote the compatibility of the density regulator, the polyethylene glycol and the polycaprolactone and ensure the fit degree of the tissue compensation glue and the skin, and the povidone K30 in the system is too little to be blended into a whole, so that the tissue compensation glue cannot be formed; the addition amount of the povidone K30 is too much, which is not beneficial to reducing the maximum gap between the tissue compensation glue and the body surface of a human body.
In a preferred embodiment of the present invention, the density adjuster is a polyolefin elastomer or paraffin wax, and the polyolefin elastomer has a melting temperature of 50 to 70 ℃.
The density modulator of the present invention is used to improve the adjustment of the density of the tissue compensation gel. Because the closer the density of the tissue compensation glue and water is, the higher the similarity of the dosimetry parameters and human tissues is, the better the effect is, the clinical requirement is that the relative density of the tissue compensation glue is 1.00 +/-0.03, however, the density of the polyethylene glycol and the polycaprolactone in the system is greater than that of the water, and therefore, the density of the tissue compensation glue is closer to that of the water by adding the density regulator with lower density.
The invention also protects a preparation method of the plastic tissue compensation glue, which comprises the following specific steps:
mixing polyethylene glycol, polycaprolactone, polyvidone K30 and a density regulator, heating and stirring uniformly, adding into a mold, cooling and demolding to obtain the tissue compensation adhesive.
In a preferred embodiment of the present invention, the heating temperature is 100 to 150 ℃. If the heating temperature is too low, the polyethylene glycol, the polycaprolactone, the povidone K30 and the density regulator are fused unevenly, the plastic tissue compensation adhesive has uneven performance, and the final plastic performance and the skin bonding performance are negatively affected. If the heating temperature is too high, the raw materials for preparation in the system may be aged.
In addition, the invention also claims the application of the plastic tissue compensation glue in radiotherapy.
Compared with the prior art, the invention has the beneficial effects that: the tissue compensation glue constructed by the invention can be shaped at the body surface temperature of a human body, and the maximum gap between the obtained tissue compensation glue and the body surface of the human body is between 0.33 and 0.44cm and is far lower than the maximum gap between the tissue compensation glue and the body surface, which is commonly used in the market, of 1.12 cm. The tissue compensation glue prepared by the invention can be used for more conveniently adapting the contour of a target area, and the problem that radiotherapy effect is influenced due to a large cavity between the compensation glue and the body surface is solved.
Drawings
FIG. 1 is a schematic diagram of the calculation of the maximum gap between the plastic tissue compensation gel and the body surface.
Detailed Description
To better illustrate the objects, aspects and advantages of the present invention, the present invention will be further described with reference to specific examples.
Example 1
The embodiment of the invention relates to a plastic tissue compensation glue and a preparation method thereof, which comprises the following specific steps:
mixing 7 parts by weight of polyethylene glycol, 45 parts by weight of polycaprolactone, 8 parts by weight of povidone K30 and 40 parts by weight of polyolefin elastomer, heating to 100 ℃, uniformly stirring, introducing into a mold, cooling to room temperature, and demolding to prepare the 30 x 0.5cm tissue compensation adhesive.
Example 2
The embodiment of the invention relates to a plastic tissue compensation glue and a preparation method thereof, which comprises the following specific steps:
mixing 15 parts by weight of polyethylene glycol, 25 parts by weight of polycaprolactone, 10 parts by weight of povidone K30 and 50 parts by weight of solid paraffin, heating to 120 ℃, uniformly stirring, introducing into a mold, cooling to room temperature, and demolding to prepare the 30 x 0.5cm tissue compensation adhesive.
Example 3
The embodiment of the invention relates to a plastic tissue compensation glue and a preparation method thereof, which comprises the following specific steps:
mixing 10 parts by weight of polyethylene glycol, 35 parts by weight of polycaprolactone, 9 parts by weight of povidone K30 and 46 parts by weight of polyolefin elastomer, heating to 150 ℃, uniformly stirring, introducing into a mold, cooling to room temperature, and demolding to prepare the 30 x 0.5cm tissue compensation adhesive.
Comparative example 1
The invention relates to a plastic tissue compensation glue and a comparative example of a preparation method thereof, which comprises the following specific steps:
mixing 15 parts by weight of polyethylene glycol, 25 parts by weight of polycaprolactone and 10 parts by weight of povidone K30, heating to 120 ℃, uniformly stirring, introducing into a mold, cooling to room temperature, and demolding to obtain the tissue compensation adhesive with the thickness of 30 x 0.5 cm.
Comparative example 2
The invention relates to a plastic tissue compensation glue and a comparative example of a preparation method thereof, which comprises the following specific steps:
mixing 15 parts by weight of polyethylene glycol, 50 parts by weight of polycaprolactone, 10 parts by weight of povidone K30 and 50 parts by weight of solid paraffin, heating to 120 ℃, uniformly stirring, introducing into a mold, cooling to room temperature, and demolding to prepare the 30 x 0.5cm tissue compensation adhesive.
Comparative example 3
The invention relates to a plastic tissue compensation glue and a comparative example of a preparation method thereof, which comprises the following specific steps:
mixing 15 parts by weight of polyethylene glycol, 25 parts by weight of polycaprolactone, 12 parts by weight of povidone K30 and 50 parts by weight of solid paraffin, heating to 120 ℃, uniformly stirring, introducing into a mold, cooling to room temperature, and demolding to prepare the 30 x 0.5cm tissue compensation adhesive.
Test example 1
Test samples: the plastic tissue compensation glues prepared in examples 1-3 and comparative examples 1-3 were used as 30 x 0.5cm tissue compensation glues in general use on the market.
The test method comprises the following steps: the test sample is covered on the local skin surface of the irradiation area of the patient, pressed to be in conformity with the body surface contour of the patient, then CT scanning is carried out, according to the maximum clearance calculation schematic diagram between the tissue compensation glue and the body surface shown in figure 1, the cavity between the tissue compensation glue and the skin is sketched, and the maximum clearance between the tissue compensation glue and the body surface is calculated, and the result is shown in the following table.
TABLE 1 test results of maximum gap between tissue compensation gel and body surface
Figure BDA0002826779830000051
FIG. 1 is a schematic diagram of the calculation of the maximum gap between the tissue compensation gel prepared in example 1 and the body surface, and it can be seen from FIG. 1 that the maximum gap between the tissue compensation gel and the body surface is 0.44cm, and meanwhile, in combination with the test results shown in Table 1, the maximum gap between the plastic tissue compensation gel and the body surface of the human body is 0.33-0.44cm under the condition of ensuring the density requirement (generally 1.00 + -0.03) of the tissue compensation gel product, which is far lower than the 1.12cm of the maximum gap between the tissue compensation gel and the body surface commonly used in the market and the tissue compensation gels prepared in comparative examples 2 and 3. The plastic tissue compensation glue prepared by the method and the limited formula raw materials can better shape the body surface contour of a patient due to the fact that the plastic tissue compensation glue can be shaped at the body surface temperature, and the influence of the secondary dose build-up effect on the radiotherapy effect is reduced.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

Claims (8)

1. The plastic tissue compensation glue is characterized by comprising the following preparation raw materials in parts by weight: 7-15 parts of polyethylene glycol, 25-45 parts of polycaprolactone, 8-10 parts of a compatilizer and 40-50 parts of a density regulator.
2. The plastic tissue compensation glue of claim 1, wherein the polyethylene glycol has a molecular weight of 750-1050.
3. The plastic tissue compensation glue of claim 1, wherein the polycaprolactone has a molecular weight of 2000-3000.
4. The plastic tissue compensation glue of claim 1, wherein the compatibilizer is povidone K30.
5. The plastic tissue compensating glue of claim 1, wherein the density modifier is a polyolefin elastomer or paraffin wax, and the polyolefin elastomer has a melting temperature of 50-70 ℃.
6. A method of preparing a plastic tissue compensating glue as claimed in any one of claims 1 to 5, comprising the steps of:
mixing polyethylene glycol, polycaprolactone, a compatilizer and a density regulator, heating and stirring uniformly, adding into a mold, cooling and demolding to obtain the tissue compensation adhesive.
7. The method for preparing plastic tissue compensation glue of claim 6, wherein the heating temperature is 100-150 ℃.
8. Use of a plastic tissue compensating gel as in claim 1 in radiation therapy.
CN202011431926.8A 2020-12-10 2020-12-10 Plastic tissue compensation glue and preparation method thereof Active CN112552661B (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113679958A (en) * 2021-08-02 2021-11-23 无锡恒成医疗科技股份有限公司 Equivalent tissue compensator and preparation method thereof
CN114887082A (en) * 2022-05-06 2022-08-12 广州科莱瑞迪医疗器材股份有限公司 Bioabsorbable materials as tumor bed markers

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US20120241493A1 (en) * 2010-09-30 2012-09-27 Ethicon Endo-Surgery, Inc. Tissue thickness compensator comprising controlled release and expansion
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CN108530852A (en) * 2017-03-01 2018-09-14 鲁传华 A kind of low-temp thermoplastic material with function far infrared radiation function
CN109316628A (en) * 2018-09-21 2019-02-12 陈炯锋 A kind of gel and its preparation method and application
CN109608842A (en) * 2018-12-18 2019-04-12 威高集团有限公司 A kind of low temperature thermo-plastic planking and preparation method thereof
CN109705806A (en) * 2018-12-27 2019-05-03 杭州恒煜医疗科技有限公司 A kind of cancer radiation therapy compensates the production method of glue with tissue
CN110917123A (en) * 2019-11-19 2020-03-27 南京大学射阳高新技术研究院 Preparation and application of medical biodegradable isolation adhesive
CN211513174U (en) * 2020-01-09 2020-09-18 深圳市同创医疗科技有限公司 Tissue compensator and tissue compensator assembly

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CN101288777A (en) * 2008-04-11 2008-10-22 东华大学 Polycaprolactone/polyethyleneglycol tissue engineering bracket material and preparation method thereof
US20120241493A1 (en) * 2010-09-30 2012-09-27 Ethicon Endo-Surgery, Inc. Tissue thickness compensator comprising controlled release and expansion
US20160310633A1 (en) * 2015-04-23 2016-10-27 Covidien Lp Adhesive compositions
CN108530852A (en) * 2017-03-01 2018-09-14 鲁传华 A kind of low-temp thermoplastic material with function far infrared radiation function
CN109316628A (en) * 2018-09-21 2019-02-12 陈炯锋 A kind of gel and its preparation method and application
CN109608842A (en) * 2018-12-18 2019-04-12 威高集团有限公司 A kind of low temperature thermo-plastic planking and preparation method thereof
CN109705806A (en) * 2018-12-27 2019-05-03 杭州恒煜医疗科技有限公司 A kind of cancer radiation therapy compensates the production method of glue with tissue
CN110917123A (en) * 2019-11-19 2020-03-27 南京大学射阳高新技术研究院 Preparation and application of medical biodegradable isolation adhesive
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113679958A (en) * 2021-08-02 2021-11-23 无锡恒成医疗科技股份有限公司 Equivalent tissue compensator and preparation method thereof
CN113679958B (en) * 2021-08-02 2023-03-24 无锡恒成医疗科技股份有限公司 Equivalent tissue compensator and preparation method thereof
CN114887082A (en) * 2022-05-06 2022-08-12 广州科莱瑞迪医疗器材股份有限公司 Bioabsorbable materials as tumor bed markers
CN114887082B (en) * 2022-05-06 2023-09-22 广州科莱瑞迪医疗器材股份有限公司 Bioabsorbable material for use as tumor bed markers

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