A type of breast implant with regional differential cohesion

Abstract

This invention discloses a breast implant with differentiated cohesive force in different regions, belonging to the field of medical implant technology. It includes an implant shell with an arc-shaped separator membrane inside. The periphery of the arc-shaped separator membrane is heat-sealed to the inner wall of the implant shell. The arc-shaped separator membrane divides the interior of the implant shell into a first cavity in the upper part and a second cavity in the lower part, with the first cavity and the second cavity completely isolated from each other. The advantage of this invention compared to existing technologies is that by dividing the interior of the implant into a completely isolated upper and lower dual-cavity structure through the arc-shaped separator membrane, differentiated performance configurations can be achieved in different regions within the same implant.

Description

Technical Field

[0001] This invention relates to the field of medical implant technology, specifically to a breast prosthesis with zoned differential cohesion. Background Technology

[0002] Most existing breast implants use a single cavity filled with the same silicone gel, resulting in relatively consistent overall mechanical properties. However, breast shape characteristics vary among different individuals, especially in terms of upper pole support requirements, nipple height and lower pole transition shape, lower pole softness and fluidity. Consequently, the feel and support requirements of different areas of the implant are not uniform.

[0003] For some East Asian women with specific breast shape needs, the upper part of the implant requires better support and a more upright feel to improve the fullness of the upper pole; while the lower part of the implant needs to be as soft as fatty tissue and have a certain degree of fluidity to create a more natural lower pole curve and feel.

[0004] Existing single gel implants cannot simultaneously meet the above two types of needs, and are prone to problems such as insufficient upper support or excessive lower hardness and unnatural shape. Therefore, it is necessary to provide a breast implant that can achieve differentiated mechanical properties in the upper and lower regions within the same implant. Summary of the Invention

[0005] The present invention aims to provide a breast implant that, by setting an upper and lower partition structure inside the same implant, provides higher support in the upper region and better softness and fluidity in the lower region, thereby taking into account both the aesthetic performance of the breast shape and the tactile requirements.

[0006] To solve the above-mentioned technical problems, the technical solution provided by the present invention is as follows: a breast implant with zoned differential cohesion, comprising an implant shell, wherein an arc-shaped partition membrane is provided inside the implant shell, the periphery of the arc-shaped partition membrane is heat-sealed to the inner wall of the implant shell, and the arc-shaped partition membrane divides the interior of the implant shell into a first cavity located in the upper part and a second cavity located in the lower part, wherein the first cavity and the second cavity are completely isolated from each other; The first cavity is filled with a first silicone gel, and the second cavity is filled with a second silicone gel; The first cavity is provided with a first filling port, and the second cavity is provided with a second filling port. The first filling port and the second filling port are used independently for filling the first cavity and the second cavity, respectively. The suspension length of the first silicone gel, as measured by the cohesive force testing method, is 3-5 mm, and the suspension length of the second silicone gel, as measured by the cohesive force testing method, is 15-30 mm. The prosthetic shell has an anatomical structure.

[0007] As an improvement, the arc-shaped separator extends along the left and right direction of the prosthesis shell and has an arc-shaped structure that conforms to the anatomical outer contour.

[0008] As an improvement, the prosthesis housing includes a front housing and a rear housing, with the periphery of the front housing and the rear housing sealed together to form a sealed inner cavity.

[0009] As an improvement, the periphery of the arc-shaped separator is fixedly connected to the inner wall of the front housing and / or the rear housing by heat sealing.

[0010] As an improvement, the first filling port and the second filling port are sealed after filling to form a sealed structure.

[0011] As an improvement, the shell thickness of the upper region of the corresponding prosthesis is less than the shell thickness of the lower region of the corresponding prosthesis, and the difference in thickness between the two is controlled within 0.15mm.

[0012] As an improvement, the first cavity is positioned to correspond to the upper pole region of the breast to provide greater support; the second cavity is positioned to correspond to the lower pole region of the breast to provide greater softness and fluidity.

[0013] As an improvement, the bottom of the prosthesis is provided with a positioning mark, which is used to position and align with the patient's nipple during the operation.

[0014] As an improvement, the cohesive force of the first silica gel in the first cavity is higher than that of the second silica gel in the second cavity.

[0015] As an improvement, the first and second cavities are kept separate in use to prevent the two types of silicone gel from mixing inside the prosthesis.

[0016] The cohesive strength test method in this manual is as follows: The test environment is 23℃±2℃; Before the test, remove the cohesive cup from the cup holder and wipe its inner and outer surfaces with a soft, lint-free cloth. Observe whether its inner surface is smooth and free of scratches, and whether the scale is deformed. Then put the cohesive cup back into the cup holder and insert the valve plate into the bottom of the cohesive cup; Subsequently, continuously squeeze the test sample gel into the cohesive cup, making the gel flush with the lower surface of the cohesive cup, and making the upper surface of the gel flush with or higher than the upper surface of the cohesive cup; Remove the valve plate at the bottom of the cohesive cup, allowing the gel in the cohesive cup to flow continuously through the lower outlet for 30 minutes without restriction, and record the length of the suspended part of the gel using the scale on the cohesive cup. The recorded suspension length is the cohesive strength test result.

[0017] Compared with the prior art, the present invention has at least the following beneficial effects: 1. The internal structure of the prosthesis is divided into upper and lower cavities that are completely isolated from each other by an arc-shaped diaphragm, which allows for differentiated performance configurations in different areas within the same prosthesis.

[0018] 2. The upper first cavity is filled with high cohesive silica gel, which can improve the support and contour stability of the upper electrode area.

[0019] 3. The lower second cavity is filled with low cohesive silicone gel, which can improve the softness and fluidity of the lower electrode area and make the shape transition more natural.

[0020] 4. The arc-shaped separator membrane is fixed by heat sealing, with a clear structure and good manufacturing feasibility.

[0021] 5. It adopts an independent filling port, which can fill the upper and lower cavities with gels of different properties separately, which facilitates process control.

[0022] 6. The anatomical shape, combined with the thin-on-top and thick-on-bottom shell design and bottom positioning marks, helps to meet the requirements for implantation directionality and positioning. Attached Figure Description

[0023] Figure 1 This is a side view of the breast implant described in this invention.

[0024] Figure 2 This is a schematic diagram of the bottom structure of the breast implant described in this invention.

[0025] Figure 3 This is a three-dimensional view of the side structure of the breast implant described in this invention.

[0026] Figure 4 This is a three-dimensional view of the bottom structure of the breast implant described in this invention.

[0027] As shown in the figure: 1-prosthetic shell, 2-arc-shaped separator, 3-first cavity, 4-second cavity, 5-first filling port, 6-second filling port, 7-positioning mark. Detailed Implementation

[0028] The specific embodiments of the present invention will be further described in detail below with reference to the accompanying drawings.

[0029] like Figures 1 to 4 As shown, the partitioned differential cohesive anatomical breast implant described in this embodiment has a main body made of medical-grade silicone rubber implant shell 1. The overall structure is an anatomical teardrop shape that conforms to the physiological morphology of the human breast. After implantation, it can match the shape of the chest wall to form a natural breast contour.

[0030] The implant shell 1 consists of two parts: a front shell and a rear shell. The front shell, which faces outward after implantation, has a smooth, outward-convex arc surface to create a fuller shape on the front of the breast. The rear shell, which conforms to the chest wall after implantation, has a relatively gentle curve to ensure stable contact with the chest wall tissue. The circumferential edges of the front and rear shells are fused together using a high-temperature heat-sealing process to form a continuous, sealed edge that encloses the sealed internal cavity of the implant. The sealed edge is trimmed to ensure a smooth, burr-free surface, preventing irritation to surrounding tissues after implantation.

[0031] An arc-shaped diaphragm 2 is provided in the internal cavity of the implant shell 1. The arc-shaped diaphragm 2 is made of medical silicone rubber film that is compatible with the material of the implant shell 1 and has good elasticity and heat-sealing adhesion. The arc-shaped diaphragm 2 extends horizontally along the left and right sides of the implant shell 1 and has an overall upward slightly arched arc structure. Its curvature is adapted to the outer contour of the anatomical implant so that the volume ratio of the upper and lower cavities matches the physiological structure ratio of the upper and lower poles of the breast. The entire circumferential edge of the arc-shaped diaphragm is fused and bonded to the inner wall of the prosthesis shell 1 by a heat-sealing process: the front edge of the arc-shaped diaphragm 2 is heat-sealed to the inner wall of the front shell, the rear edge is heat-sealed to the inner wall of the rear shell, and the edges at both ends extend to the inner walls of the left and right sides of the prosthesis shell 1 and are heat-sealed. Through the connection structure of full circumferential heat sealing, the arc-shaped diaphragm 2 completely divides the internal cavity of the prosthesis shell 1 into the upper first cavity 3 and the lower second cavity 4. The two cavities are independent of each other and completely sealed and isolated. During the entire period of implantation and use, the materials are kept separate, which can completely avoid the mixing of the two silicone gels inside the prosthesis and ensure the long-term stability of the partitioning performance.

[0032] The first cavity 3 corresponds to the upper pole region of the human breast and is filled with a first silicone gel; the second cavity 4 corresponds to the lower pole region of the human breast and is filled with a second silicone gel. According to the cohesive force test method described in this instruction manual, the suspension length of the first silicone gel is 3-5mm, which is a high-cohesive silicone gel with strong shape retention ability. It can provide stable support for the upper pole region, maintain the full and upright shape of the upper pole of the breast, and reduce the risk of sagging and deformation after long-term implantation. The suspension length of the second silicone gel is 15-30mm, which is a low-cohesive silicone gel with high softness and natural flow. It can simulate the real touch of human adipose tissue and make the lower pole of the breast curve transition naturally and softly.

[0033] The bottom of the prosthesis shell 1 has two independent filling channels: a first filling port 5 and a second filling port 6. The inner end of the first filling port 5 is connected to the first cavity 3, and the inner end of the second filling port 6 is connected to the second cavity 4. These two channels do not interfere with each other and can independently fill the corresponding cavities with silicone gel of the appropriate properties. This allows for separate control of the filling volume and performance parameters of the two types of gel during the production process. After the silicone gel filling is completed, the first filling port 5 and the second filling port 6 are permanently sealed using medical-grade silicone rubber sealants combined with a heat-sealing process, forming a complete sealed structure and eliminating the risk of silicone gel leakage after implantation.

[0034] Furthermore, the wall thickness of the implant shell 1 is distributed differently: the shell thickness corresponding to the upper first cavity 3 region is relatively thin, which can better transmit the support performance of the internal high cohesive gel and ensure the upper pole shape is upright; the shell thickness corresponding to the lower second cavity 4 region is relatively thick, which can improve the structural strength and tear resistance of the lower pole region; and the difference in shell thickness between the upper and lower regions is controlled within 0.15mm, so that the overall feel of the implant is smooth and natural, and there will be no obvious tactile discontinuity.

[0035] The bottom outer surface of the implant shell 1 is also provided with a positioning mark 7. The positioning mark 7 is located on the longitudinal center line of the implant and is formed by laser engraving technology. The mark is clear and will not fall off. During the implantation surgery, the doctor can align the positioning mark 7 with the position of the patient's nipple, quickly complete the orientation calibration and precise placement of the anatomical implant, ensure the accurate implantation direction, and improve the symmetry and aesthetics of the bilateral breast shape after surgery.

[0036] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present invention, and these all fall within the protection scope of the present invention.

Claims

1. A breast implant with zoned differential cohesion, comprising an implant shell, characterized in that: The prosthesis housing has an arc-shaped partition membrane inside. The periphery of the arc-shaped partition membrane is heat-sealed to the inner wall of the prosthesis housing. The arc-shaped partition membrane divides the inside of the prosthesis housing into a first cavity located in the upper part and a second cavity located in the lower part. The first cavity and the second cavity are completely isolated from each other. The first cavity is filled with a first silicone gel, and the second cavity is filled with a second silicone gel; The first cavity is provided with a first filling port, and the second cavity is provided with a second filling port. The first filling port and the second filling port are used independently for filling the first cavity and the second cavity, respectively. The suspension length of the first silicone gel, as measured by the cohesive force testing method, is 3-5 mm, and the suspension length of the second silicone gel, as measured by the cohesive force testing method, is 15-30 mm. The prosthetic shell has an anatomical structure.

2. The breast implant with zoned differential cohesion according to claim 1, characterized in that: The arc-shaped separator extends along the left and right direction of the prosthesis shell and has an arc-shaped structure that matches the anatomical outer contour.

3. A breast implant with zoned differential cohesion according to claim 2, characterized in that: The prosthetic housing includes a front housing and a rear housing, and the periphery of the front housing and the rear housing are sealed together to form a sealed inner cavity.

4. A breast implant with zoned differential cohesion according to claim 3, characterized in that: The periphery of the arc-shaped separator is fixedly connected to the inner wall of the front shell and / or the rear shell by heat sealing.

5. A breast implant with zoned differential cohesion according to claim 4, characterized in that: After filling, the first filling port and the second filling port are sealed to form a sealed structure.

6. A breast implant with zoned differential cohesion according to claim 5, characterized in that: The shell thickness of the upper region of the corresponding implant is less than the shell thickness of the lower region of the corresponding implant, and the difference in thickness between the two is controlled within 0.15mm.

7. A breast implant with zoned differential cohesion according to claim 6, characterized in that: The first cavity is positioned corresponding to the upper pole region of the breast to provide greater support; the second cavity is positioned corresponding to the lower pole region of the breast to provide greater softness and fluidity.

8. A breast implant with zoned differential cohesion according to claim 7, characterized in that: The prosthesis has a positioning mark at its bottom, which is used to position and align with the patient's nipple during the operation.

9. A breast implant with zoned differential cohesion according to claim 8, characterized in that: The cohesive force of the first silica gel in the first cavity is higher than that of the second silica gel in the second cavity.

10. A breast implant with zoned differential cohesion according to claim 9, characterized in that: The first and second cavities are kept separate in use to prevent the two types of silicone gel from mixing inside the prosthesis.

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