A split breast implant and method of manufacture

Abstract

The present application discloses a split breast implant and a manufacturing method. The envelope of the breast implant is circular in the projection in the overhead direction, and the projection of the breast implant in the side direction is arc-shaped. The breast implant has a plurality of flexible capsules which are arrayed around a center to form a petal-shaped structure. The breast implant of the present application adopts a split structure, can be implanted better, and the plurality of flexible capsules can be used in combination or each petal can be used alone, so as to be suitable for patients with partial mastectomy, and has the advantages of simple structure and strong practicability.

Description

TECHNICAL FIELD

[0001] The present application relates to a split breast implant and a manufacturing method. BACKGROUND

[0002] Implantable prostheses are generally used to replace or augment body tissue. For example, for patients with small breasts, mild breast ptosis and breast defects, breast prostheses such as silicone gel breast prostheses can be implanted in the body tissue to support the surrounding tissue to maintain the appearance of the body.

[0003] The existing breast implants are all of a whole body type, and have the defect of poor applicability. SUMMARY

[0004] The present application provides a split breast implant and a manufacturing method, which has the advantages of simple structure and strong practicability.

[0005] The specific technical scheme of the present application is as follows:

[0006] A split breast implant, the envelope of the breast implant in the projection direction is circular, and the projection of the breast implant in the side direction is arc-shaped, wherein the breast implant has a plurality of flexible capsules, and the plurality of flexible capsules are arrayed around a center to form a petal-shaped structure.

[0007] According to another specific embodiment of the present application, the diameter of the circle ranges from 80 to 200 mm, and the height of the arc ranges from 15 to 75 mm.

[0008] According to another specific embodiment of the present application, the number of flexible capsules is 3 to 18 petals.

[0009] According to another specific embodiment of the present application, the flexible capsules are silicone gel-filled capsules, and the volume of the flexible capsules is 10 to 100 ml.

[0010] According to another specific embodiment of the present application, the flexible capsules have arc-shaped transitions between two adjacent surfaces.

[0011] A manufacturing method of a split breast implant, comprising the following steps:

[0012] 1) Manufacturing of the shell and the cover:

[0013] 1.1) Dissolve the two-component silicone rubber thoroughly, and mix the dissolved silicone rubber A / B components in equal proportions at a ratio of 1:1;

[0014] 1.2) Pour the prepared silicone rubber solution into the shell mold and the cover mold, respectively, and perform vulcanization treatment;

[0015] 1.3) peeling off the shell from the shell mold and the cover from the cover mold after vulcanization;

[0016] 2) Synthesis of raw rubber

[0017] 2.1) octamethylcyclotetrasiloxane, di-vinyltetramethyldisiloxane, and tetramethylammonium hydroxide are put into a reaction kettle according to a ratio of 100:0.8-1.2:0.1-0.3,

[0018] 2.2) the reaction kettle is vacuumized, the temperature in the reaction kettle is controlled to 70-80°C, and nitrogen is bubbled to remove water;

[0019] 2.3) tetramethylammonium hydroxide catalyst is put into the reaction kettle, and the temperature is raised to 95-105°C to perform polymerization reaction;

[0020] 2.4) the temperature of the reaction kettle is raised to fully decompose the catalyst;

[0021] 2.5) the temperature of the reaction kettle is raised again, and vacuumization is performed to remove low molecular substances;

[0022] 2.6) the temperature is lowered to room temperature to obtain the synthesized raw rubber;

[0023] 3) Covering

[0024] 3.1) the shell and the cover are cleaned with purified water;

[0025] 3.2) the two-component silicone rubber is dissolved, and the dissolved silicone rubber A / B components are mixed according to a ratio of 1:1 to obtain a viscous rubber sheet;

[0026] 3.3) after the cover and the shell dipped with the viscous rubber sheet are bonded, vulcanization treatment is performed;

[0027] 4) Rubber injection

[0028] 4.1) preparation of silicone gel: raw rubber, crosslinking agent, and catalyst are mixed uniformly according to a ratio of 100:0.3-0.5:0.01;

[0029] 4.2) a small hole is formed at the covering part of the shell to form a rubber injection channel;

[0030] 4.3) the prepared silicone gel is injected into the shell along the small hole, and vacuumization is performed to exhaust air;

[0031] 4.4) the small hole is closed with medical silicone rubber;

[0032] 4.5) vulcanization treatment is performed to crosslink the silicone gel;

[0033] 7. The method of claim 6, further comprising:

[0034] 5) Package sterilization

[0035] 5.1) Inner package: clean the product with purified water, and use PET bubble cap and gummed paper for double-layer sealed package;

[0036] 5.2) Perform irradiation sterilization;

[0037] 5.3) Outer package: package the product after irradiation sterilization with a carton.

[0038] According to another specific embodiment of the present application, the temperature of the reactor is raised to 158-163 DEG C in step 2.4) to fully decompose the catalyst; and the temperature of the reactor is raised to 185-190 DEG C again in step 2.5) and vacuum is applied to remove low molecular weight substances.

[0039] According to another specific embodiment of the present application, the two-component silicone rubber is fully dissolved in step 1.1) by dissolving 40-60 g of silicone rubber A / B component per 500 ml of solvent.

[0040] According to another specific embodiment of the present application, the temperature of the vulcanization treatment in step 4.5) is lower than the temperature of the vulcanization treatment in step 1.2) and step 3.3), wherein the temperature of the vulcanization treatment in step 1.2) and step 3.3) ranges from 150 DEG C to 170 DEG C, and the temperature of the vulcanization treatment in step 4.5) ranges from 130 DEG C to 150 DEG C.

[0041] The present application has the following advantages:

[0042] The breast implant of the present application adopts a split structure, can be implanted better, and the multiple flexible sacs can be used in combination or individually, so as to be suitable for patients with partial mastectomy, and has the advantages of simple structure and strong practicability.

[0043] The present application will be further described in detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0044] Figure 1 is a structure diagram of an embodiment of the breast implant of the present application;

[0045] Figure 2 is a top view of Figure 1 ;

[0046] Figure 3 is a side view of Figure 1 ;

[0047] Figure 4 is a distribution diagram of the shell and the cover in an embodiment of the manufacturing method of the breast implant of the present application. DETAILED DESCRIPTION

[0048] In order to more clearly understand the above-mentioned purposes, features and advantages of the present application, the present application will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the embodiments of the present application and the features in the embodiments can be combined with each other without conflict.

[0049] In the following description, a large number of specific details are set forth in order to facilitate a thorough understanding of the present application, however, the present application can also be implemented in other manners different from those described herein, and therefore, the scope of protection of the present application is not limited to the specific embodiments disclosed below.

[0050] Example 1

[0051] The present embodiment provides a split breast implant, as shown in Figure 1 The envelope of the breast implant 10 is circular in the projection in the top view, the diameter range R of the circle is 80-200mm, and the projection of the breast implant in the side view is an arc, the height range L of the arc is 15-75mm, and specifically, the arc of the arc is a minor arc.

[0052] The breast implant has a plurality of flexible capsules 11, and specifically, the number of the flexible capsules 11 is 3-18 petals, for example, 6 petals as shown in Figure 2 The plurality of flexible capsules 11 are arrayed around a center O to form a petal structure.

[0053] Further, the flexible capsule 11 is a silicone gel-filled capsule, and the volume of the flexible capsule 11 is 10-100ml.

[0054] Still further, the flexible capsule 11 has an arc-shaped transition between two adjacent surfaces.

[0055] The breast implant in the present embodiment adopts a split structure, and the plurality of flexible capsules 11 can be used in combination or each petal can be used alone to be suitable for patients with partial mastectomy.

[0056] Example 2

[0057] The present embodiment provides a manufacturing method of a split breast implant, as shown in Figure 4 Each petal of the flexible capsule is manufactured separately, which includes the following steps:

[0058] 1) Manufacturing of the shell 21 and the cover 22:

[0059] 1.1) Dissolve the two-component silicone rubber thoroughly, and mix the dissolved silicone rubber A / B components in equal proportions at 1:1. Here, the two-component silicone rubber is dissolved thoroughly in 40-60 g of silicone rubber A / B components per 500 ml of solvent to obtain sufficient silicone rubber solution.

[0060] 1.2) Pour the prepared silicone rubber solution into the shell mold and the cover mold, respectively, and perform vulcanization treatment at a temperature range of 150-170°C for a time range of 90-150 min.

[0061] 1.3) Peel the shell 21 from the shell mold and the cover 22 from the cover mold after vulcanization.

[0062] 2) Synthesis of raw rubber

[0063] 2.1) Put octamethylcyclotetrasiloxane, divinyltetramethyldisiloxane, and tetramethylammonium hydroxide into a reaction kettle in a ratio of 100:0.8-1.2:0.1-0.3,

[0064] 2.2) Perform vacuum treatment on the reaction kettle, control the temperature in the reaction kettle to 70-80°C, and bubble nitrogen to remove water.

[0065] 2.3) Put tetramethylammonium hydroxide catalyst into the reaction kettle, and heat to 95-105°C to perform polymerization.

[0066] 2.4) Increase the temperature of the reaction kettle to 158-163°C to fully decompose the catalyst.

[0067] 2.5) Again increase the temperature of the reaction kettle to 185-190°C, and perform low-molecular removal by vacuum.

[0068] 2.6) Reduce the temperature to room temperature to obtain the synthesized raw rubber.

[0069] 3) Covering

[0070] 3.1) Wash the shell 21 and the cover 22 with purified water.

[0071] 3.2) Mix the two-component silicone rubber A / B components in equal proportions at 1:1 to obtain a viscous adhesive sheet.

[0072] 3.3) After the cover 22 and the shell 21 dipped with the viscous adhesive sheet are bonded, perform vulcanization treatment at a temperature range of 150-170°C for a time range of 90-150 min.

[0073] 4) Rubber injection

[0074] 4.1) Preparation of silicone gel: raw rubber, cross-linking agent and catalyst are mixed in the ratio of 100:0.3-0.5:0.01;

[0075] 4.2) A small hole is made in the cover portion of the housing 21 to form a channel for injecting the gel;

[0076] 4.3) The prepared silicone gel is injected into the housing 21 through the small hole and vacuum is applied to remove air;

[0077] 4.4) The small hole is closed with medical silicone rubber;

[0078] 4.5) Vulcanization treatment is carried out to cross-link the silicone gel, wherein the temperature of the vulcanization treatment is 130-150°C and the time range of the vulcanization treatment is 90-150 min;

[0079] 5) Packaging and sterilization

[0080] 5.1) Inner packaging: The product is washed with purified water and double sealed packaged using PET bubble pack and gummed paper;

[0081] 5.2) Irradiation sterilization is carried out;

[0082] 5.3) Outer packaging: The product (i.e. the flexible sac) after irradiation sterilization is packed in a carton.

[0083] In this embodiment, the size is adjusted as required to obtain different combinations of breast implants.

[0084] Although the present application has been disclosed with reference to the preferred embodiments, it is not intended to limit the scope of the application. Any person skilled in the art, without departing from the scope of the application, can make some improvements, i.e. any equivalent improvement made according to the present application should be covered by the scope of the present application.

Claims

1. A split breast implant, the envelope of which in plan view is circular, the projection of which in side view is arcuate, characterised in that, The breast implant has a plurality of flexible sacs which are arrayed around a center to form a petal-shaped structure, and each petal of the plurality of flexible sacs is independent and can be used in combination or individually; two adjacent surfaces of the plurality of flexible sacs have an arc-shaped transition. The breast implant comprises a shell, a cover and a silicone gel injected into the shell; the shell and the cover are made of two-component silicone rubber, and the silicone gel is made of octamethylcyclotetrasiloxane, divinyltetramethyldisiloxane and tetramethylammonium hydroxide.

2. The split breast implant of claim 1, wherein, The diameter of the circle ranges from 80 to 200 mm, and the height of the arc ranges from 15 to 75 mm.

3. The split breast implant of claim 1, wherein, The number of the plurality of flexible sacs is 3 to 18 petals.

4. The split breast implant of claim 1, wherein, The flexible sacs are silicone gel-filled sacs, and the volume of the flexible sacs is 10 to 100 ml.

5. The split breast implant of claim 3, wherein, The number of the plurality of flexible sacs is 6 petals.

6. The split breast implant of claim 1, wherein, The shell and the cover are bonded together by bonding the viscous adhesive film obtained by dissolving the two-component silicone rubber.

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