Silicone rubber compensation film for radiotherapy, preparation method of silicone rubber compensation film and application of silicone rubber compensation film in preparation of postoperative radiotherapy articles for radical treatment of breast cancer

Abstract

The invention discloses a silicone rubber compensation film for radiotherapy, a preparation method of the silicone rubber compensation film and application of the silicone rubber compensation film in preparation of radiotherapy products after radical breast cancer treatment. The silicone rubber compensation film for radiotherapy is obtained by mixing and curing a component A and a component B, the component A contains vinyl silicone oil A, a filler, an additive and a platinum catalyst; and the component B contains vinyl silicone oil B, hydrogen-containing silicone oil, a filler, an additive and a pigment. The silicone rubber compensation film for radiotherapy prepared by the preparation method can be completely attached to the chest wall to reduce air gaps, so that the dose distribution of a target region and organs at risk is improved, and the repeatability and stability of the dose between treatment fractions are ensured. The silicone rubber compensation film for radiotherapy prepared by the preparation method can be completely attached to the chest wall to reduce air gaps, so that the dose distribution of a target region and organs at risk is improved, the repeatability and stability of the dose between treatment fractions are ensured, and therefore, the silicone rubber compensation film can be applied to preparation of radiotherapy products after radical treatment of breast cancer.

Description

Technical Field

[0001] The present invention relates to the technical field of medical materials, and particularly relates to a silicone rubber compensating film for radiotherapy, a preparation method thereof, and the use of the silicone rubber compensating film in the preparation of radiotherapy supplies after radical mastectomy for breast cancer. Background Art

[0002] Radiotherapy after radical mastectomy for breast cancer can reduce the local recurrence rate and prolong the overall survival of patients. When treating, covering the tissue equivalent material on the skin surface can increase the chest wall dose, solve the influence of the dose build-up effect, and achieve a good target dose distribution. Traditional tissue equivalent materials include conventional boluses made of paraffin, thermoplastic materials, gauze, vaseline and other materials. The above-mentioned conventional boluses have many disadvantages. For example, paraffin has an obvious gap with the chest wall due to its physical properties; thermoplastic materials are hard in texture, and it is difficult to ensure the fitting accuracy between fractions ( Figure 1 ); the moisture absorption characteristics of gauze will cause surface dose fluctuations; the vaseline material is too soft and prone to compressive deformation under external force.

[0003] 3D printed boluses are also widely used in breast cancer radiotherapy, but the air gap at the concave skin cannot be completely eliminated, and the body surface contour cannot be perfectly reproduced. As a superficial tumor, breast cancer requires placing a bolus on the chest wall surface of the patient during treatment to increase the skin build-up thickness and thereby increase the skin dose. Clinical radiotherapy often uses a fixed and general equivalent tissue bolus ( Figure 2 ), but its shape is solidified and it is difficult to accurately match the curvature of the patient's chest wall. Especially for complex anatomical structures such as the skin depression after breast resection or the parasternal lymphatic drainage area, abnormal dose deposition often occurs due to incomplete contact surface fitting.

[0004] Therefore, in view of the deficiencies of the existing technology, providing a silicone rubber compensating film for radiotherapy and its preparation method, and clarifying the use of the compensating film in the preparation of radiotherapy supplies after radical mastectomy for breast cancer is of great significance for solving the defects of the existing technology. Summary of the Invention

[0005] The first object of the present invention is to overcome the defects of the existing technology and provide a silicone rubber compensating film for radiotherapy. This silicone rubber compensating film for radiotherapy can not only completely fit the chest wall, reduce the air gap, but also improve the dose distribution of the target area and organs at risk, and ensure the repeatability and stability of the dose between treatment fractions.

[0006] The above object of the present invention is achieved by the following technical measures:

[0007] A silicone rubber compensating film for radiotherapy is provided and obtained by mixing and curing component A and component B.

[0008] The component A contains vinyl silicone oil, filler, additive and platinum catalyst.

[0009] Component B contains vinyl silicone oil, hydrogen-containing silicone oil, filler, additive and pigment.

[0010] Define the vinyl silicone oil in Component A as vinyl silicone oil A, and the vinyl silicone oil A is vinyl-terminated dimethyl polysiloxane.

[0011] Define the vinyl silicone oil in Component B as vinyl silicone oil B, and the vinyl silicone oil B contains vinyl-terminated dimethyl polysiloxane, acrylic acid-modified vinyl-terminated dimethyl polysiloxane and glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane.

[0012] Preferably, the preparation method of the above acrylic acid-modified vinyl-terminated dimethyl polysiloxane is to react vinyl-terminated dimethyl polysiloxane with acrylic acid under the action of azobisisobutyronitrile to obtain the acrylic acid-modified vinyl-terminated dimethyl polysiloxane.

[0013] Preferably, the preparation method of the above glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane is to react vinyl-terminated dimethyl polysiloxane with glycidyl acrylate under the action of azobisisobutyronitrile to obtain the glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane.

[0014] Preferably, the weight ratio of Component A to Component B of the above silicone rubber compensation film for radiotherapy is 1:0.8 - 1.2.

[0015] In Component A, by weight:

[0016] Vinyl silicone oil A: 30 parts - 70 parts;

[0017] Filler: 50 parts - 80 parts;

[0018] Additive: 0.2 parts - 3 parts;

[0019] Platinum catalyst: 0.1 parts - 3 parts.

[0020] In Component B, by weight:

[0021] Vinyl silicone oil B: 30 parts - 70 parts;

[0022] Hydrogen-containing silicone oil: 5 parts - 30 parts;

[0023] Filler: 50 parts - 80 parts;

[0024] Additive: 0.1 parts - 3 parts;

[0025] Pigment: 0.1 parts - 0.8 parts.

[0026] In the vinyl silicone oil B, by weight:

[0027] Vinyl polydimethylsiloxane: 50 to 80 parts;

[0028] Acrylic acid modified vinyl end-capped dimethyl polysiloxane: 10 to 20 parts;

[0029] Glycidyl acrylate modified vinyl end-capped dimethyl polysiloxane: 5 to 10 parts.

[0030] Preferably, the weight ratio of component A to component B of the above-mentioned silicone rubber compensating film for radiotherapy is 1:1.

[0031] In component A, by weight:

[0032] Vinyl silicone oil A: 56 parts;

[0033] Filler: 62 parts;

[0034] Additive: 1.8 parts;

[0035] Platinum catalyst: 2.4 parts.

[0036] In component B, by weight:

[0037] Vinyl silicone oil B: 55 parts;

[0038] Hydrogen-containing silicone oil: 17 parts;

[0039] Filler: 72 parts;

[0040] Additive: 1.5 parts; [[ID=4۳]]

[0041] Pigment: 0.5 part.

[0042] In the vinyl silicone oil B, by weight:

[0043] Vinyl polydimethylsiloxane: 60 parts;

[0044] Acrylic acid modified vinyl end-capped dimethyl polysiloxane: 15 parts;

[0045] Glycidyl acrylate modified vinyl end-capped dimethyl polysiloxane: 7 parts.

[0046] Preferably, the above-mentioned additive is a surfactant.

[0047] Preferably, the above-mentioned filler is quartz powder with a particle size of 1000 mesh to 5000 mesh.

[0048] A silicone rubber compensating film for radiotherapy according to the present invention is obtained by mixing and curing component A and component B; the silicone rubber compensating film for radiotherapy is obtained by mixing and curing component A and component B; component A contains vinyl silicone oil, filler, additive and platinum catalyst; component B contains vinyl silicone oil, hydrogen-containing silicone oil, filler, additive and pigment. The vinyl silicone oil in component A is defined as vinyl silicone oil A, and the vinyl silicone oil A is vinyl-terminated dimethyl polysiloxane; the vinyl silicone oil in component B is defined as vinyl silicone oil B, and the vinyl silicone oil B contains vinyl-terminated dimethyl polysiloxane, acrylic acid-modified vinyl-terminated dimethyl polysiloxane and glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane; the preparation method of the acrylic acid-modified vinyl-terminated dimethyl polysiloxane is to react vinyl-terminated dimethyl polysiloxane with acrylic acid under the action of azobisisobutyronitrile to obtain the acrylic acid-modified vinyl-terminated dimethyl polysiloxane; the preparation method of the glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane is to react vinyl-terminated dimethyl polysiloxane with glycidyl acrylate under the action of azobisisobutyronitrile to obtain the glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane. In the present invention, the mixture of component A and component B is a plastic substance in the early stage, so as to completely fit the action site. After mixing for a period of time, component A and component B crosslink the vinyl silicone oil A and vinyl silicone oil B, so as to solidify and form a personalized silicone rubber compensating film for radiotherapy. The silicone rubber compensating film for radiotherapy of the present invention can completely fit the action site when it is just mixed, so that it can completely fit the chest wall and reduce the air gap. After curing, it can be used. The silicone rubber compensating film for radiotherapy can not only improve the dose distribution of the target area and organs at risk, but also ensure the repeatability and stability of the dose between treatment fractions.

[0049] The second object of the present invention is to overcome the defects of the prior art and provide a preparation method of a silicone rubber compensating film for radiotherapy. The silicone rubber compensating film for radiotherapy obtained by using this preparation method can closely fit the chest wall, effectively reduce the air gap, and at the same time improve the dose distribution of the target area and organs at risk, and ensure the repeatability and stability of the dose between treatment fractions.

[0050] The above object of the present invention is achieved by the following technical measures:

[0051] Provide a preparation method of the above-mentioned silicone rubber compensating film for radiotherapy. Component A and component B are mixed through a mixing system to obtain a pre-silicone rubber compensating film for radiotherapy. Then, the pre-silicone rubber compensating film for radiotherapy is laid on the action site and pressed to completely fit the action site. Finally, it is cooled and formed to obtain a personalized silicone rubber compensating film for radiotherapy.

[0052] Preferably, the above mixing system is provided with:

[0053] Input module - The input object requires the size and thickness of the silicone rubber compensation film for radiotherapy. The weights of component A and component B are calculated according to the size and thickness of the silicone rubber compensation film for radiotherapy.

[0054] First storage bin - Store component A.

[0055] Second storage bin - Store component B.

[0056] Screw mixing module - According to the weights of component A and component B obtained from the input module, add the corresponding weights of component A from the first storage bin and component B from the second storage bin, and then mix component A and component B to obtain a pre-radiotherapy silicone rubber compensation film.

[0057] Rolling and flattening module - Press the pre-radiotherapy silicone rubber compensation film mixed by the screw mixing module into the radiotherapy silicone rubber compensation film with the corresponding size and thickness according to the size and thickness of the input module.

[0058] The preparation method of the silicone rubber compensation film for radiotherapy of the present invention mixes component A and component B through a mixing system to obtain a pre-radiotherapy silicone rubber compensation film, then spreads the pre-radiotherapy silicone rubber compensation film on the acting site and presses it to completely fit the acting site, and finally cools and forms to obtain a personalized radiotherapy silicone rubber compensation film. The preparation method of the radiotherapy silicone rubber compensation film mixes through a mixing system, and can also automatically calculate the weights of component A and component B according to the size and thickness of the radiotherapy silicone rubber compensation film, and finally obtain a radiotherapy silicone rubber compensation film with the corresponding size and thickness. Moreover, the radiotherapy silicone rubber compensation film obtained by this preparation method can completely fit the chest wall to reduce the air gap, and after cooling and forming, a radiotherapy silicone rubber compensation film that completely matches the acting site is obtained, and it can also be reused; the radiotherapy silicone rubber compensation film can also improve the dose distribution of the target area and organs at risk, and ensure the repeatability and stability of the dose between treatment fractions.

[0059] The third object of the present invention is to overcome the defects of the prior art and provide a use of a silicone rubber compensation film in the preparation of radiotherapy supplies after radical mastectomy for breast cancer. Since the radiotherapy silicone rubber compensation film prepared by the preparation method of the radiotherapy silicone rubber compensation film can completely fit the chest wall, reduce the air gap, and can also improve the dose distribution of the target area and organs at risk, and ensure the repeatability and stability of the dose between treatment fractions, the silicone rubber compensation film can be used in the preparation of radiotherapy supplies after radical mastectomy for breast cancer.

[0060] The above objects of the present invention are achieved by the following technical measures:

[0061] Provide a use of a silicone rubber compensating film in the preparation of radiotherapy supplies after radical mastectomy for breast cancer, wherein the silicone rubber compensating film is the radiotherapy silicone rubber compensating film obtained by the above-mentioned preparation method of the radiotherapy silicone rubber compensating film.

[0062] Regarding the use of the silicone rubber compensating film of the present invention in the preparation of radiotherapy supplies after radical mastectomy for breast cancer, since the radiotherapy silicone rubber compensating film obtained by the preparation method of the radiotherapy silicone rubber compensating film can completely fit the chest wall, reduce the air gap, and can also improve the dose distribution of the target area and organs at risk, ensuring the repeatability and stability of the dose between treatment fractions. Therefore, the silicone rubber compensating film can be used in the preparation of radiotherapy supplies after radical mastectomy for breast cancer. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 CT image when the thermoplastic compensating film adheres to the chest wall.

[0064] Figure 2 CT image when the gel compensating film adheres to the chest wall.

[0065] Figure 3 CT image of the silicone rubber compensating film of the present invention adhering to the chest wall for the first time.

[0066] Figure 4 CT image of the silicone rubber compensating film of the present invention adhering to the chest wall for the third time.

[0067] Figure 5 CT image of the silicone rubber compensating film of the present invention adhering to the chest wall for the fifth time.

[0068] Figure 6 DVH comparison diagram of the planned CT and the fifth CT of the silicone rubber compensating film of the present invention.

[0069] Figure 7 Signal and material flow diagram of the hybrid system of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0070] The technical solutions of the present invention will be further described in conjunction with the following embodiments. Unless otherwise specified in the following embodiments, the raw materials used in each embodiment are commercially available products. The experimental methods in the following embodiments are all conventional methods unless otherwise specified.

[0071] Example 1

[0072] A radiotherapy silicone rubber compensating film is obtained by mixing and curing Component A and Component B. Component A contains vinyl silicone oil A, filler, additive, and platinum catalyst. Component B contains vinyl silicone oil B, hydrogen-containing silicone oil, filler, additive, and pigment. The additive is a surfactant; the filler is quartz powder with a particle size of 1000 mesh. The effective platinum content in the platinum catalyst is 10000 ppm.

[0073] Among them, vinyl silicone oil A is vinyl-terminated dimethyl polysiloxane; vinyl silicone oil B contains vinyl-terminated dimethyl polysiloxane, acrylic acid-modified vinyl-terminated dimethyl polysiloxane, and glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane. The vinyl content of the vinyl-terminated dimethyl polysiloxane is 0.5 mol%, and the viscosity is 2000 mPa·s.

[0074] The weight ratio of component A to component B of the silicone rubber compensating film for radiotherapy is 1:0.8.

[0075] In component A by weight:

[0076] Vinyl silicone oil A: 70 parts;

[0077] Filler: 50 parts;

[0078] Additive: 0.2 part;

[0079] Platinum catalyst: 0.1 part.

[0080] In component B by weight:

[0081] Vinyl silicone oil B: 70 parts;

[0082] Hydrogen-containing silicone oil: 5 parts;

[0083] Filler: 50 parts;

[0084] Additive: 3 parts;

[0085] Pigment: 0.8 part.

[0086] In vinyl silicone oil B, by weight:

[0087] Vinyl polydimethylsiloxane: 80 parts;

[0088] Acrylic acid-modified vinyl-terminated dimethyl polysiloxane: 10 parts;

[0089] Glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane: 5 parts.

[0090] The preparation method of the acrylic acid-modified vinyl-terminated dimethyl polysiloxane of the present invention is to react vinyl-terminated dimethyl polysiloxane with acrylic acid under the action of azobisisobutyronitrile to obtain acrylic acid-modified vinyl-terminated dimethyl polysiloxane.

[0091] The preparation method of acrylic acid modified vinyl terminated dimethyl polysiloxane is as follows: Under nitrogen protection, vinyl terminated dimethyl polysiloxane and acrylic acid are mixed and heated to 70 °C - 73 °C, then added to the mixture of vinyl terminated dimethyl polysiloxane and acrylic acid in a toluene solution of 3% wt azobisisobutyronitrile, and reacted for 2 h. After vacuum distillation, acrylic acid modified vinyl terminated dimethyl polysiloxane is obtained, where the weight ratio of vinyl terminated dimethyl polysiloxane, acrylic acid and azobisisobutyronitrile is 100:1:0.1.

[0092] The preparation method of glycidyl acrylate modified vinyl terminated dimethyl polysiloxane is to react vinyl terminated dimethyl polysiloxane with glycidyl acrylate under the action of azobisisobutyronitrile to obtain glycidyl acrylate modified vinyl terminated dimethyl polysiloxane.

[0093] The preparation method of glycidyl acrylate modified vinyl terminated dimethyl polysiloxane is as follows: Under nitrogen protection, vinyl terminated dimethyl polysiloxane and glycidyl acrylate are mixed and heated to 76 °C - 78 °C, then added to the mixture of vinyl terminated dimethyl polysiloxane and glycidyl acrylate in a toluene solution of 2% wt azobisisobutyronitrile, and reacted for 5 h. After vacuum distillation, glycidyl acrylate modified vinyl terminated dimethyl polysiloxane is obtained, where the weight ratio of vinyl terminated dimethyl polysiloxane, glycidyl acrylate and azobisisobutyronitrile is 100:2:0.2.

[0094] The preparation method of the silicone rubber compensating film for radiotherapy of the present invention is to mix component A and component B, then spread it on the acting part and press it to completely fit the acting part, and finally cool and form to obtain a personalized silicone rubber compensating film for radiotherapy.

[0095] When the silicone rubber compensating film for radiotherapy is just mixed, it can completely fit the acting part, so it can completely fit the chest wall and reduce the air gap. After curing, it can be used. And this silicone rubber compensating film for radiotherapy can not only improve the dose distribution of the target area and organs at risk, but also ensure the repeatability and stability of the dose between treatment fractions.

[0096] Example 2

[0097] A silicone rubber compensating film for radiotherapy is obtained by mixing and curing component A and component B. Component A contains vinyl silicone oil A, filler, additive and platinum catalyst. Component B contains vinyl silicone oil B, hydrogen-containing silicone oil, filler, additive and pigment. The additive is a surfactant; the filler is quartz powder with a particle size of 5000 mesh. The effective platinum content in the platinum catalyst is 10000 ppm.

[0098] Among them, vinyl silicone oil A is a vinyl-terminated dimethyl polysiloxane; vinyl silicone oil B contains vinyl-terminated dimethyl polysiloxane, acrylic acid-modified vinyl-terminated dimethyl polysiloxane, and glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane. The vinyl content of the vinyl-terminated dimethyl polysiloxane is 0.5 mol%, and the viscosity is 2000 mPa·s.

[0099] The weight ratio of component A to component B of the silicone rubber compensating film for radiotherapy is 1:1.2.

[0100] In component A by weight:

[0101] Vinyl silicone oil A: 30 parts;

[0102] Filler: 80 parts;

[0103] Additive: 3 parts;

[0104] Platinum catalyst: 3 parts.

[0105] In component B by weight:

[0106] Vinyl silicone oil B: 30 parts;

[0107] Hydrogen-containing silicone oil: 30 parts;

[0108] Filler: 80 parts;

[0109] Additive: 0.1 part;

[0110] Pigment: 0.1 part.

[0111] In vinyl silicone oil B, by weight:

[0112] Vinyl polydimethylsiloxane: 50 parts;

[0113] Acrylic acid-modified vinyl-terminated dimethyl polysiloxane: 20 parts;

[0114] Glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane: 10 parts.

[0115] The preparation method of the acrylic acid-modified vinyl-terminated dimethyl polysiloxane of the present invention is to react vinyl-terminated dimethyl polysiloxane with acrylic acid under the action of azobisisobutyronitrile to obtain acrylic acid-modified vinyl-terminated dimethyl polysiloxane.

[0116] The preparation method of acrylic acid modified vinyl terminated dimethyl polysiloxane is as follows: Under nitrogen protection, vinyl terminated dimethyl polysiloxane and acrylic acid are mixed and heated to 70 °C - 73 °C, then added to the mixture of vinyl terminated dimethyl polysiloxane and acrylic acid in a toluene solution of 3% wt azobisisobutyronitrile, and reacted for 2 h. After vacuum distillation, acrylic acid modified vinyl terminated dimethyl polysiloxane is obtained, where the weight ratio of vinyl terminated dimethyl polysiloxane, acrylic acid and azobisisobutyronitrile is 100:3:0.1.

[0117] The preparation method of glycidyl acrylate modified vinyl terminated dimethyl polysiloxane is to react vinyl terminated dimethyl polysiloxane with glycidyl acrylate under the action of azobisisobutyronitrile to obtain glycidyl acrylate modified vinyl terminated dimethyl polysiloxane.

[0118] The preparation method of glycidyl acrylate modified vinyl terminated dimethyl polysiloxane is as follows: Under nitrogen protection, vinyl terminated dimethyl polysiloxane and glycidyl acrylate are mixed and heated to 76 °C - 78 °C, then added to the mixture of vinyl terminated dimethyl polysiloxane and glycidyl acrylate in a toluene solution of 2% wt azobisisobutyronitrile, and reacted for 5 h. After vacuum distillation, glycidyl acrylate modified vinyl terminated dimethyl polysiloxane is obtained, where the weight ratio of vinyl terminated dimethyl polysiloxane, glycidyl acrylate and azobisisobutyronitrile is 100:1:0.2.

[0119] The preparation method of the silicone rubber compensating film for radiotherapy of the present invention is to mix component A and component B, then spread them on the action site and apply pressure to make them fully fit with the action site, and finally cool and form to obtain a personalized silicone rubber compensating film for radiotherapy.

[0120] When the silicone rubber compensating film for radiotherapy is just mixed, it can fully fit with the action site, so as to closely fit the chest wall and reduce the air gap. It can be used after curing is completed. The silicone rubber compensating film for radiotherapy can not only improve the dose distribution of the target area and organs at risk, but also ensure the repeatability and stability of the dose between treatment fractions.

[0121] Example 3

[0122] A silicone rubber compensating film for radiotherapy is obtained by mixing and curing component A and component B. Component A contains vinyl silicone oil A, filler, additive and platinum catalyst. Component B contains vinyl silicone oil B, hydrogen-containing silicone oil, filler, additive and pigment. The additive is a surfactant; the filler is quartz powder with a particle size of 3500 mesh. The effective platinum content in the platinum catalyst is 10000 ppm.

[0123] Among them, vinyl silicone oil A is vinyl-terminated dimethyl polysiloxane; vinyl silicone oil B contains vinyl-terminated dimethyl polysiloxane, acrylic acid-modified vinyl-terminated dimethyl polysiloxane, and glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane. The vinyl content of the vinyl-terminated dimethyl polysiloxane is 0.5 mol%, and the viscosity is 2000 mPa·s.

[0124] The weight ratio of component A to component B of the silicone rubber compensating film for radiotherapy is 1:1.

[0125] In component A by weight:

[0126] Vinyl silicone oil A: 56 parts;

[0127] Filler: 62 parts;

[0128] Additive: 1.8 parts;

[0129] Platinum catalyst: 2.4 parts;

[0130] In component B by weight:

[0131] Vinyl silicone oil B: 55 parts;

[0132] Hydrogen-containing silicone oil: 17 parts;

[0133] Filler: 72 parts;

[0134] Additive: 1.5 parts;

[0135] Pigment: 0.5 part.

[0136] In vinyl silicone oil B, by weight:

[0137] Vinyl polydimethylsiloxane: 60 parts;

[0138] Acrylic acid-modified vinyl-terminated dimethyl polysiloxane: 15 parts;

[0139] Glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane: 7 parts.

[0140] The preparation method of the acrylic acid-modified vinyl-terminated dimethyl polysiloxane of the present invention is to react vinyl-terminated dimethyl polysiloxane with acrylic acid under the action of azobisisobutyronitrile to obtain acrylic acid-modified vinyl-terminated dimethyl polysiloxane.

[0141] The preparation method of acrylic acid-modified vinyl-terminated dimethyl polysiloxane is as follows: Under nitrogen protection, vinyl-terminated dimethyl polysiloxane and acrylic acid are mixed and heated to 70 °C to 73 °C, and then added to the mixture of vinyl-terminated dimethyl polysiloxane and acrylic acid in a toluene solution of 3% wt azobisisobutyronitrile, and reacted for 2 h. After vacuum distillation, acrylic acid-modified vinyl-terminated dimethyl polysiloxane is obtained, where the weight ratio of vinyl-terminated dimethyl polysiloxane, acrylic acid and azobisisobutyronitrile is 100:2:0.1.

[0142] The preparation method of glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane is to react vinyl-terminated dimethyl polysiloxane with glycidyl acrylate under the action of azobisisobutyronitrile to obtain glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane.

[0143] The preparation method of glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane is as follows: Under nitrogen protection, vinyl-terminated dimethyl polysiloxane and glycidyl acrylate are mixed and heated to 76 °C to 78 °C, and then added to the mixture of vinyl-terminated dimethyl polysiloxane and glycidyl acrylate in a toluene solution of 2% wt azobisisobutyronitrile, and reacted for 5 h. After vacuum distillation, glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane is obtained, where the weight ratio of vinyl-terminated dimethyl polysiloxane, glycidyl acrylate and azobisisobutyronitrile is 100:1.5:0.2.

[0144] The preparation method of the silicone rubber compensating film for radiotherapy of the present invention is to mix component A and component B, then spread it on the acting part and press it to fit completely with the acting part, and finally cool and form to obtain a personalized silicone rubber compensating film for radiotherapy.

[0145] When the silicone rubber compensating film for radiotherapy is just mixed, it can fit completely with the acting part, so as to closely fit the chest wall and reduce the air gap, and can be used after curing. The silicone rubber compensating film for radiotherapy can not only improve the dose distribution of the target area and organs at risk, but also ensure the repeatability and stability of the dose between treatment fractions.

[0146] Comparative Example 1

[0147] A silicone rubber compensating film for radiotherapy, other features are the same as those in Example 3, the difference is that:

[0148] In component A by weight:

[0149] Vinyl silicone oil A: 80 parts;

[0150] Filler: 62 parts;

[0151] Additive: 1.8 parts;

[0152] Platinum catalyst: 2.4 parts;

[0153] In component B by weight:

[0154] Vinyl silicone oil B: 80 parts;

[0155] Hydrogen-containing silicone oil: 17 parts;

[0156] Filler: 72 parts;

[0157] Additive: 1.5 parts;

[0158] Pigment: 0.5 part.

[0159] In vinyl silicone oil B, by weight:

[0160] Vinyl polydimethylsiloxane: 90 parts;

[0161] Acrylic acid-modified vinyl-terminated dimethylpolysiloxane: 15 parts;

[0162] Glycidyl acrylate-modified vinyl-terminated dimethylpolysiloxane: 7 parts.

[0163] Comparative Example 2

[0164] A silicone rubber compensating film for radiotherapy, with other features the same as in Example 3, the difference being:

[0165] In component A by weight:

[0166] Vinyl silicone oil A: 56 parts;

[0167] Filler: 62 parts;

[0168] Additive: 1.8 parts;

[0169] Platinum catalyst: 2.4 parts;

[0170] In component B by weight:

[0171] Vinyl silicone oil B: 55 parts;

[0172] Hydrogen-containing silicone oil: 17 parts;

[0173] Filler: 72 parts;

[0174] Additive: 1.5 parts;

[0175] Pigment: 0.5 part.

[0176] In vinyl silicone oil B, by weight:

[0177] Vinyl polydimethylsiloxane: 30 parts;

[0178] Acrylic acid modified vinyl-terminated dimethyl polysiloxane: 35 parts;

[0179] Glycidyl acrylate modified vinyl-terminated dimethyl polysiloxane: 7 parts.

[0180] Comparative Example 3

[0181] A silicone rubber compensating film for radiotherapy, with other features being the same as those in Example 3, except that.

[0182] In Component A, by weight:

[0183] Vinyl silicone oil A: 56 parts;

[0184] Filler: 62 parts;

[0185] Additive: 1.8 parts;

[0186] Platinum catalyst: 2.4 parts;

[0187] In Component B, by weight:

[0188] Vinyl silicone oil B: 55 parts;

[0189] Hydrogen-containing silicone oil: 17 parts;

[0190] Filler: 72 parts;

[0191] Additive: 1.5 parts;

[0192] Pigment: 0.5 part.

[0193] Vinyl silicone oil B contains acrylic acid modified vinyl-terminated dimethyl polysiloxane and glycidyl acrylate modified vinyl-terminated dimethyl polysiloxane.

[0194] In vinyl silicone oil B, by weight:

[0195] Acrylic acid modified vinyl-terminated dimethyl polysiloxane: 15 parts;

[0196] Glycidyl acrylate modified vinyl-terminated dimethyl polysiloxane: 7 parts.

[0197] Effect Example

[0198] 1. Softness

[0199] After mixing the corresponding components A and B in Examples 1-3 and Comparative Examples 1-3 for 10 seconds, the hardness was tested according to the test standard GB / T531.1-2008, the tensile strength was tested according to GB / T528-2009, the tear strength was tested according to GB / T529-2009, the elongation at break was tested according to GB / T528-2009, and the curing time was tested according to YY04943-2011. The data obtained are shown in Table 1:

[0200] Table 1. Mechanical properties of the mixture of component A and component B

[0201]

[0202] 2. Repeatability

[0203] The silicone rubber compensation membranes for radiotherapy obtained in Examples 1-3 and Comparative Examples 1-3 were reused, and the number of uses was tested as shown in Table 2.

[0204] Table 2. Number of times of testing and use

[0205] Once Twice Thrice Four times Five times Ten times Fifteen times Example 1 ok ok ok ok ok ok ok Example 2 ok ok ok ok ok ok ok Example 3 ok ok ok ok ok ok ok Comparative Example 1 ok ok ok Damaged - Comparative Example 2 ok ok Damaged - - Comparative Example 3 ok ok Damaged - -

[0206] 3. Dose-Volume Histogram of the Silicone Rubber Compensation Membrane for Radiotherapy of the Present Invention during Radiotherapy

[0207] In actual radiotherapy treatment, the radiotherapy plan was for 3 weeks, with 5 times per week and no radiotherapy on weekends. A total of 15 radiotherapy sessions were carried out, and each radiotherapy session was performed using the silicone rubber compensation membrane for radiotherapy of the present invention. CT scans were performed daily for the first three days of the first week, and then only once in the second and third weeks, that is, the original planned CT1 ((FBCT1) to the third CT scan (FBCT3), the fourth CT scan (FBCT4) was performed on Friday of the second week, and the fifth CT scan (FBCT5) was performed on Friday of the third week.

[0208] Among them, the dose-volume histogram results after fusing the original planned CT1 (FBCT1) and the fifth CT scan (FBCT5) are as Figure 6 shown. In Figure 6 , the target areas include PTV1-50-e, PTV-50-e, PTV2-50-e, PTV3-50; OARs include the heart, lungs, spinal cord, etc. Among them, the dose indexes of CT1 are represented by “—”, and the dose indexes of FBCT5 are represented by “…”.

[0209] Through Figure 6 it can be seen that the dose index curves of each target area and OARs are close, highly consistent, and the differences are small. Therefore, the dose index curves of the silicone rubber compensation membrane for radiotherapy of the present invention in the entire treatment process are close to the original planned dose index curves.

[0210] 4. Results of the silicone rubber compensating film for radiotherapy of the present invention in treating FBCT

[0211] Compared with the original plan (CT1), in the 5 CT scans (FBCT1 - FBCT5) during the actual treatment using the silicone rubber compensating film for radiotherapy in Example 3, the dose - volume evaluation indexes D mean 、D 95％ 、V 105％ and V 95％ of the PTV are shown in Table 3. The CT scan plan in Table 4 is the same as that of Figure 6 .

[0212] Table 3. Comparison of PTV evaluation indexes before and during treatment of 30 patients

[0213]

[0214] When directly performing radiotherapy on patients with breast resection after surgery, the dose irradiation is mainly concentrated in the lungs. By adding a compensating film, it is equivalent to adding a part on the skin surface, and radiotherapy makes the high - dose area stable at 1 cm below the skin and subcutaneous layer. However, the performance of the compensating film in the prior art, such as repeatability, thickness, density, etc., affects the stability of the dose distribution in the target area during irradiation.

[0215] As can be seen from Table 3, during the actual treatment using the silicone rubber compensating film for radiotherapy in Example 3, the D mean 、D 95％ 、V 105％ and V 95％ target coverage rates of the target area all meet the clinical requirements, V 95％ ≥95%, V 105％ ≤25%, D 95％ >95%.

[0216] As can be seen from Table 3, comparing the V 105％ of the planned CT (CT1) with the results of the 5 FBCTs (FBCT1 - FBCT5) during the actual treatment using the silicone rubber compensating film for radiotherapy, there is no statistically significant difference in the results of FBCT. Although the D mean 、D 95％ and V 95％Slightly lower than the treatment plan, and the difference was statistically significant (P<0.05). However, the target coverage rate during actual treatment still met the clinical requirements; the differences between the HI and CI of the original plan and during actual treatment were statistically significant (P<0.05), and the treatment plan had more advantages. Therefore, it was proved that the silicone rubber compensating film for radiotherapy of the present invention could still meet the clinical requirements after being used 15 times. Therefore, it was proved that the silicone rubber compensating film for radiotherapy of the present invention maintained good conformability during the 15 - time use, and the dose distribution in the target area was relatively stable throughout the radiotherapy process.

[0217] 5. Compared with the original plan (CT1), the evaluation indexes of OARs treated with the silicone rubber compensating film for radiotherapy of the present invention. During the actual treatment process (FBCT1 - FBCT5) using the silicone rubber compensating film for radiotherapy of Example 3, the Dmean, V5, V 20 of the affected - side lung, V5 of the heart, and D max of the spinal cord. The results are shown in Table 4. The CT scan plan in Table 4 is the same as Figure 6 the CT scan plan of

[0218] Table 4. Comparison of OARs evaluation indexes before and during treatment of 30 patients

[0219]

[0220] Note: * represents that the difference is statistically significant compared with CT1 (P<0.05)

[0221] As can be seen from Table 4, compared with the original plan (CT1) and the actual treatment (FBCT1 - FBCT5) of the silicone rubber compensating film for radiotherapy of the present invention, there were no differences in D mean , V5, V 20 of the affected - side lung, V5 of the heart, and D max of the spinal cord; during the treatment process, V 30 of the lung was slightly lower than the treatment plan (P<0.05). Therefore, it was proved that the silicone rubber compensating film for radiotherapy of the present invention could still meet the clinical requirements after being used 15 times.

[0222] In summary, the silicone rubber compensating film for radiotherapy prepared by the preparation method of the silicone rubber compensating film for radiotherapy of the present invention can completely conform to the chest wall to reduce the air gap, and can also improve the dose distribution of the target area and organs at risk after multiple uses, ensuring the repeatability and stability of the dose between treatment fractions.

[0223] Example 4

[0224] A preparation method of a silicone rubber compensating film for radiotherapy such as that in Examples 1 to 3 through a mixing system, such as Figure 7As shown, component A and component B are mixed to obtain a silicone rubber compensation film for pre-radiotherapy, and then the silicone rubber compensation film for pre-radiotherapy is spread on the action site and then pressurized to completely fit the action site, and finally cooled and formed to obtain a personalized silicone rubber compensation film for radiotherapy.

[0225] The hybrid system setup is:

[0226] Input module: input the size and thickness of the silicone rubber compensation film for radiotherapy required by the object, and calculate the weight of component A and component B respectively according to the size and thickness of the silicone rubber compensation film for radiotherapy;

[0227] The first storage warehouse - storage component A;

[0228] Second storage warehouse - storage component B;

[0229] Spiral mixing module: according to the weights of component A and component B obtained from the input module, the corresponding weight of component A is added from the first storage bin, the corresponding weight of component B is added from the second storage bin, and then component A and component B are mixed to obtain a silicone rubber compensation film for pre-radiotherapy;

[0230] Rolling module: the pre-radiotherapy silicone rubber compensation film mixed by the spiral mixing module is pressed into a radiotherapy silicone rubber compensation film of corresponding size and thickness according to the size and thickness of the input module.

[0231] The present invention pre-places components A and B into first and second storage bins, respectively. An operator then enters the size and thickness of the desired radiotherapy silicone rubber compensating film into an input module, which then calculates the required amounts of components A and B. A spiral mixing module then adds and removes components A and B from the first and second storage bins, thoroughly mixing them to produce the pre-radiotherapy silicone rubber compensating film. A flattening module then presses the pre-radiotherapy silicone rubber compensating film into a corresponding size and thickness based on the size and thickness of the input module.

[0232] It should be noted that the spiral mixing module of the present invention is a device for uniformly mixing different materials. This device is a common device in industrial production, and its specific structure will not be described in detail. The flattening module is a device for pressing materials into a layered structure. This device is a common device in industrial production, and its specific structure will not be described in detail.

[0233] The preparation method of the silicone rubber compensating film for radiotherapy is mixed through a mixing system, and can automatically calculate the weights of component A and component B respectively according to the size and thickness of the silicone rubber compensating film for radiotherapy, and finally obtain the silicone rubber compensating film for radiotherapy with corresponding size and thickness. Moreover, the silicone rubber compensating film for radiotherapy obtained by this preparation method can completely fit the chest wall to reduce the air gap, and after cooling and forming, obtain the silicone rubber compensating film for radiotherapy that perfectly matches the acting site, and can also be reused; the silicone rubber compensating film for radiotherapy can also improve the dose distribution of the target area and organs at risk, and ensure the repeatability and stability of the dose between treatment fractions.

[0234] Example 5

[0235] The use of a silicone rubber compensating film in the preparation of radiotherapy supplies after radical mastectomy for breast cancer, wherein the silicone rubber compensating film is the silicone rubber compensating film for radiotherapy obtained by the preparation method of the silicone rubber compensating film for radiotherapy in Examples 1 to 3.

[0236] Based on the data of the effect examples of the silicone rubber compensating film for radiotherapy above, the silicone rubber compensating film of the present invention can be used in the preparation of radiotherapy supplies after radical mastectomy for breast cancer.

[0237] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit the protection scope of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that the technical solutions of the present invention can be modified or equivalently replaced without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A silicone rubber compensating film for radiotherapy, characterized in that: The silicone rubber compensation film for radiotherapy is obtained by mixing and curing component A and component B; Component A contains vinyl silicone oil, filler, additive and platinum catalyst; Component B contains vinyl silicone oil, hydrogen-containing silicone oil, filler, additive and pigment.

2. The silicone rubber compensating film for radiotherapy according to claim 1, wherein: The vinyl silicone oil in component A is defined as vinyl silicone oil A, and the vinyl silicone oil A is vinyl-terminated dimethyl polysiloxane; The vinyl silicone oil in component B is defined as vinyl silicone oil B, and the vinyl silicone oil B contains vinyl-terminated dimethyl polysiloxane, acrylic acid-modified vinyl-terminated dimethyl polysiloxane and glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane; The preparation method of the acrylic acid-modified vinyl-terminated dimethyl polysiloxane is to react vinyl-terminated dimethyl polysiloxane with acrylic acid under the action of azobisisobutyronitrile to obtain the acrylic acid-modified vinyl-terminated dimethyl polysiloxane; The preparation method of the glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane is to react vinyl-terminated dimethyl polysiloxane with glycidyl acrylate under the action of azobisisobutyronitrile to obtain the glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane.

3. The silicone rubber compensating film for radiotherapy according to claim 2, wherein: The weight ratio of component A and component B of the silicone rubber compensation film for radiotherapy is 1:0.8 - 1.2; In component A by weight: Vinyl silicone oil A: 30 parts - 70 parts; Filler: 50 parts - 80 parts; Additive: 0.2 parts - 3 parts; Platinum catalyst: 0.1 parts - 3 parts; In component B by weight: Vinyl silicone oil B: 30 parts - 70 parts; Hydrogen-containing silicone oil: 5 parts - 30 parts; Filler: 50 parts - 80 parts; Additive: 0.1 parts - 3 parts; Pigment: 0.1 parts - 0.8 parts.

4. The silicone rubber compensating film for radiotherapy according to claim 2 or 3, characterized in that: The weight ratio of component A and component B of the silicone rubber compensation film for radiotherapy is 1:1; In component A by weight: Vinyl silicone oil A: 56 parts; Filler: 62 parts; Additive: 1.8 parts; Platinum catalyst: 2.4 parts; In component B by weight: Vinyl silicone oil B: 55 parts; Hydrogen-containing silicone oil: 17 parts; Filler: 72 parts; Additive: 1.5 parts; Pigment: 0.5 parts.

5. The silicone rubber compensating film for radiotherapy according to any one of claims 1 to 4, characterized in that: In the vinyl silicone oil B, by weight: Vinyl polydimethylsiloxane: 50 parts - 80 parts; Acrylic acid-modified vinyl-terminated dimethyl polysiloxane: 10 parts - 20 parts; Glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane: 5 parts - 10 parts.

6. The silicone rubber compensating film for radiotherapy according to claim 5, characterized in that: In the vinyl silicone oil B, by weight: Vinyl polydimethylsiloxane: 60 parts; Acrylic acid-modified vinyl-terminated dimethyl polysiloxane: 15 parts; Glycidyl acrylate-modified vinyl-terminated dimethyl polysiloxane: 7 parts.

7. The silicone rubber compensating film for radiotherapy according to any one of claims 1 to 4, characterized in that: The additive is a surfactant; The filler is quartz powder with a particle size of 1000 mesh - 5000 mesh.

8. A method for preparing a silicone rubber compensation film for radiotherapy according to any one of claims 1 to 7, characterized in that: Component A and component B are mixed through a mixing system to obtain a pre-silicone rubber compensation film for radiotherapy, then the pre-silicone rubber compensation film for radiotherapy is laid on the acting part and then pressed to completely fit with the acting part, and finally cooled and formed to obtain a personalized silicone rubber compensation film for radiotherapy.

9. The preparation method of the silicone rubber compensating film for radiotherapy according to claim 8, characterized in that: The mixing system is provided with: Input module - The input object requires the size and thickness of the silicone rubber compensation film for radiotherapy, and calculates the weights of the component A and the component B respectively according to the size and thickness of the silicone rubber compensation film for radiotherapy; First storage bin - Stores the component A; Second storage bin - Stores the component B; Screw mixing module - According to the weights of the component A and the component B obtained from the input module, adds the corresponding weight of the component A from the first storage bin and the corresponding weight of the component B from the second storage bin, and then mixes the component A and the component B to obtain a pre-radiotherapy silicone rubber compensation film; Rolling and flattening module - Presses the pre-radiotherapy silicone rubber compensation film mixed by the screw mixing module into the radiotherapy silicone rubber compensation film with the corresponding size and thickness according to the size and thickness of the input module.

10. Use of a silicone rubber compensation film in the preparation of radiotherapy supplies after radical mastectomy for breast cancer, characterized in that: The silicone rubber compensation film is the radiotherapy silicone rubber compensation film obtained by the preparation method of the radiotherapy silicone rubber compensation film described in claim 8 or 9.

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