CN112206082A

CN112206082A - Method for preparing high-activity artificial breast

Info

Publication number: CN112206082A
Application number: CN201910615518.9A
Authority: CN
Inventors: 王杰; 高泳涛; 何奇; 魏敏
Original assignee: International Peace Maternity & Child Health Hospital Of China Welfare Institute
Current assignee: International Peace Maternity & Child Health Hospital Of China Welfare Institute
Priority date: 2019-07-09
Filing date: 2019-07-09
Publication date: 2021-01-12

Abstract

The invention relates to a method for preparing high-activity artificial breast, which comprises the following steps: (1.1) acquiring 3D digital data; (1.2) collecting inferior fold data; (2) establishing a diseased artificial breast digital model comprising inferior plica; (3) establishing a digital model of the breast prosthesis mould, wherein a separation membrane is arranged in the digital model; (4) manufacturing a breast prosthesis mould; and (5) artificial breast preparation. The artificial breast prepared by the method can restore the affected breast and has higher mobility.

Description

Method for preparing high-activity artificial breast

Technical Field

The invention relates to the field of medical treatment, in particular to a method for preparing artificial breast.

Background

The breast is an important part of the female body and represents the female characteristics and the sexual beauty. Breast deletion refers to partial deletion, morphological deformity or badness of breast tissue caused by benign and malignant lesion excision of breast, trauma and congenital breast dysplasia. For women, both unilateral resection and bilateral resection can cause the loss of the original tissues of the body and cause the asymmetry of the body, which can cause pain or deformation of cervical vertebra, spine, shoulders, arms, and other parts.

The artificial breast, also called false breast or artificial breast, is the most ideal substitute for people with breast loss except breast replacement, and can effectively eliminate the internal uneasiness of women after operation after wearing the artificial breast.

The size, shape and body form of the female breast are different. In part of benign operations, because the removed glandular tissues have large quantity, the shape of the breast is changed, and operations of reconstructing and repairing the shape of the breast at the defect part are needed; partial malignant surgery requires cleaning of axillary lymph resulting in a large amount of tissue damage. The surgical incision, the position of the scar, the size, the height and the like of the patient are different, so that the existing breast prosthesis product which simply imitates the general shape of the breast cannot meet the practical application requirements of people.

Although there are some products with a high degree of emulation (or recovery), there are some significant disadvantages including inconvenience of wearing, discomfort over extended periods of wear (e.g., redness, irritation, or inflammation), inability to fit snugly, poor tactile feel, poor mobility, etc.

In conclusion, there is no satisfactory artificial breast in the art, especially one satisfying the individual needs and having a high degree of restitution. Therefore, the development of the artificial breast which meets the personalized needs, has the recovery degree close to 100 percent (98 to 100 percent), is suitable for long-term wearing and close-fitting wearing is urgently needed in the field.

Disclosure of Invention

The invention aims to provide a preparation method with high activity, which is particularly suitable for the prolapsed I type and the prolapsed II type artificial breasts.

In a first aspect of the present invention, there is provided a method of preparing a high-activity artificial breast, said method comprising the steps of:

(1) acquisition of 3D digitized data of breast contour and inferior fold data

(1.1) acquiring 3D digital data;

3D scanning the shape of the postoperative healthy breast or preoperative affected breast of the user to obtain 3D data of the healthy breast, wherein the data are 3D digital data;

(1.2) collecting inferior fold data;

(1.2.1) establishing a virtual D-line in the affected breast area of the user, the D-line being a horizontal line drawn through the uppermost point of the user's stem;

(1.2.2) taking 5 or more points D on the D line, and respectively marking as D₁、D₂、……D_nWherein n is more than or equal to 5; the distance from each point D to the midline of the bone handle is L₁、L₂、……L_n；

(1.2.3) measuring the distance h from each point D to the line A along the vertical direction respectively and recording the distance h as h₁、 h₂、……h_n(ii) a And

(1.2.4) data (L)_m，h_m) I.e. the required crease line data, wherein m represents any integer from 1 to n;

(2) establishing a diseased artificial breast digital model comprising inferior plica;

(2.1) establishing a preliminary digital model of the artificial breast;

(i) establishing a digital model of the postoperative healthy breast and a central sagittal plane of the digital model based on the 3D digital data; and, relative to the central sagittal plane, carrying out mirror image conversion on the health-side breast digital model so as to obtain a preliminary digital model of the artificial breast preset on the affected side; wherein the digitized model of the healthy breast and the preliminary digitized model of the affected breast are substantially or completely bilaterally symmetric; or, (ii) based on the 3D digital data, establishing a digital model of the affected breast before operation, thereby obtaining a preliminary digital model of a prosthesis preset on the affected side; wherein the digitized model of the preoperative affected breast and the preliminary digitized model of the affected breast are substantially or completely overlapped;

and the preliminary digitized model of the breast prosthesis comprises a line B representing the frontal profile of the lower half of the breast; and

(2.2) establishing a laterologous breast prosthesis digital model comprising inferior folds;

(2.2.1) determining the uppermost point of the bone shank in the preliminary digital model, and establishing a D line based on the uppermost point of the bone shank;

(2.2.2) based on the uppermost point of the pedicle, D-line and the data pair (L) obtained in step (1.2.4)_m， h_m) Determining each point x in said preliminary digitised model_mI.e. determining x₁、x₂……x_n(ii) a And

(2.2.3) connecting the points x_mThereby creating an a-line representing the inferior plica, thereby resulting in a lateral breast prosthesis model including the inferior plica;

(3) establishing a digital model of the breast prosthesis mould, wherein a separation membrane is arranged in the digital model;

(3.1) establishing a digital model of a digital breast prosthesis mould based on the digital model of the breast prosthesis on the affected side;

(3.2) establishing a separation film in the digital breast model based on a region enclosed by the line A and the line B (namely based on a region C enclosed by the line A and the line B); and

(3.3) creating a digital parting plane for the digital model of the breast model, and splitting the digital model of the breast model to obtain a split digital part of the breast model;

(4) manufacturing a breast prosthesis mould:

forming a part of a solid breast prosthesis mould including a separation membrane by 3D printing based on the digitalized part; and

(5) preparing artificial breast;

and (3) putting and/or injecting the artificial breast raw material into the artificial breast mould for solidification, thereby obtaining the high-activity artificial breast.

In another preferred embodiment, the separation membrane is used for forming a part of the high-activity artificial breast which can movably coincide with the skin of the chest wall.

In another preferred example, in step (1.2.2), 5-40 points D are taken on the D line.

In another preferred embodiment, 5 to 30 (preferably, n is an integer of 5 to 20; more preferably, n is an integer of 8 to 20) points D are taken on the D line.

In another preferred example, n is an integer of 5 to 40; preferably, n is an integer of 5 to 30; more preferably, n is an integer of 5 to 20; most preferably, n is an integer of 8 to 20.

In another preferred embodiment, the spacing between adjacent dots D (i.e., L when m ≧ 2)_m-L_m-1Value of) or D₁Distance to midline or of sternum (i.e. L when m is 1)₁Value of (d) is 0.25 to 1.5 cm.

In another preferred embodiment, L_n-L_n-1Or L₁The value of (A) is 0.75-1.25 cm; more preferably, 1. + -. 0.1 cm.

In another preferred example, the separation film is used for forming a superposition attaching part of the simulated real breast and the chest wall skin in the artificial breast.

In another preferred example, in step (3), the digitizing means of the split breast prosthesis mold comprises: a digital male mold part and a digital female mold part (the digital male mold part and the digital female mold part can form an inner cavity for forming the artificial breast after being combined).

In another preferred example, in the step (3), the separation film is located on a female mold digital model.

In another preferred example, in the step (3), the separating film is positioned on a female breast prosthesis mould.

In another preferred example, in step (3), the digitizing means of the split breast prosthesis mold comprises: the separation membrane component, the digital male mold component and the digital female mold component (the separation membrane component, the digital male mold component and the digital female mold component can form an inner cavity for forming the artificial breast after being combined).

In another preferred example, in the step (3), the inner cavity (surface) of the female mold corresponds to the protrusion of the artificial breast.

In another preferred example, in the step (3), irregular stripes and punctate depressions are processed at the nipple areola of the female mold part to imitate the physiological texture of the surface of the nipple areola.

In another preferred example, in the step (3), the inner cavity (face) of the male mold corresponds to the breast wall fitting face (or base) of the breast prosthesis.

In another preferred example, in the step (3), the inner cavity (surface) of the male mold is provided with a plurality of protrusions.

In another preferred example, in the step (3), the cross-sectional shape of the protrusion is: circular, oval, diamond, or irregular.

In another preferred example, in the step (3), the area of the convex section is 3-4cm²And 0.7-1.2cm²。

In another preferred embodiment, in the step (3), the protrusion is used for forming a cavity on the back surface (i.e. the chest wall attaching surface) of the breast prosthesis product.

In another preferred embodiment, in the step (3), the cavity is a circular cavity with a cross section of 2 ± 0.5cm or 1 ± 0.3cm in diameter.

In another preferred example, step (4) further comprises a trimming and/or modifying step of the breast mould.

In another preferred example, the positive breast prosthesis mould and the negative breast prosthesis mould obtained in the step (4) are matched with each other and can form a breast prosthesis forming cavity corresponding to the digital model of the breast prosthesis.

In another preferred example, in step (4), the trimming and/or modifying step includes: polishing, buffing, or a combination thereof.

In another preferred example, the step (2) further comprises trimming the edges of the digital model (i.e. determining the edge range of the digital model required by the digital mold).

In another preferred example, in the step (2), the clipping range is determined by a quadrilateral.

In another preferred example, the pruning range is: from the superior (superior) to 2 + -1 cm below the clavicle, medially to the midline of the clavicle, inferiorly (inferior) to 2 + -1 cm below the inframammary fold, and/or laterally to the posterior axillary line + -2 cm.

In another preferred example, in step (2), the "mirror image conversion" includes the steps of: turning the digital model of the breast room on the healthy side to the affected side to obtain a digital model of the mirror image breast; the digital model of the mirror image breast is symmetrical to the healthy side breast by position adjustment.

In another preferred example, in step (2), the position adjustment includes: rotation, translation, or a combination thereof.

In another preferred example, in the step (2), the affected breast prosthesis model further comprises a rear surface attached to the surface of the postoperative chest wall.

In another preferred example, the step (2) further comprises the steps of:

(2.3) establishing a digital model of affected side breast prosthesis comprising a posterior surface

(2.3.1) establishing a digital model of the postoperative chest of the affected side based on the 3D digital data of the external shape of the postoperative chest of the affected side of the user; and

(2.3.2) establishing a rear surface of the affected side breast prosthesis digitalized model attached to the surface of the postoperative chest wall based on the affected side postoperative chest digitalized model.

In another preferred example, in step (1), the 3D scanning includes: infrared scanning, visible light scanning, or a combination thereof.

In another preferred example, in the step (1), the acquisition of the 3D digitized data is performed by scanning a healthy breast of the patient after surgery by a 3D infrared scanner for a unilateral breast cutting patient.

In another preferred example, in the step (1), the 3D digitized data is acquired by CT scanning the affected breast of the patient before operation, for a unilateral breast cutting patient.

In another preferred example, in the step (1), for a unilateral breast cutting patient, the acquisition of the 3D digitized data is performed by MRI scanning the affected breast of the patient before operation.

In another preferred example, in the step (1), for a patient with bilateral breast cancer, the acquisition of the 3D digitized data is performed by CT scanning the breast on the affected side of the patient before operation.

In another preferred example, in the step (1), for a patient with bilateral breast cancer, the acquiring of the 3D digital data is performed by MRI scanning the affected breast of the patient before operation.

In another preferred example, in the step (1), the shape of the breast of the user is scanned in 3D while the user is standing or sitting.

In another preferred example, in the step (1), the shape of the healthy breast of the user is 3D-scanned while the user is lying down.

In another preferred example, in the step (1), the method comprises the following steps: adopt a data acquisition module, scan patient's truck through 3D infrared scanner to can mark healthy tissue and cutting tissue with different colours according to the cutting condition of patient's operation.

In another preferred embodiment, the artificial milk raw material is selected from the following group: (i) a silica gel feedstock, or (ii) a combination of a silica gel feedstock and a filler material.

In another preferred embodiment, the filling material is selected from the group consisting of: a bladder, a gas, water (preferably saline), or a combination thereof.

In another preferred example, the filling material is arranged in the silica gel cavity.

In another preferred embodiment, the bladder includes a bladder-like housing and a bladder cavity defined by the bladder-like housing.

In another preferred example, the capsule-shaped shell is a silica gel capsule-shaped shell.

In another preferred embodiment, the capsule contains contents.

In another preferred embodiment, the contents are selected from the group consisting of: gas, water, or a combination thereof; preferably, it is selected from the group consisting of a combination of gas and water.

In another preferred example, the water is normal saline water.

In another preferred example, the silica gel raw material is a liquid raw material; preferably, the silicone collagen material comprises: liquid silica gel, a curing agent, and optionally a solvent.

In another preferred example, the silica gel comprises medical silica gel.

In another preferred embodiment, the mixing ratio of the silica gel to the curing agent is 1:2 to 2: 1.

In another preferred embodiment, the silica gel is a color-matched silica gel.

In another preferred embodiment, the raw material for 3D printing is selected from the group consisting of: a resin, polylactic acid, polyvinyl alcohol, or a combination thereof.

In another preferred embodiment, the resin is a photosensitive resin, preferably a Somos resin material from DSM.

In another preferred embodiment, the shape of the artificial breast is accurately restored (including shape, weight and the like) to approximately 100% (such as 98-100%) relative to the affected breast of the user after the operation.

In another preferred embodiment, the method further comprises the following steps: (6) improving artificial breast;

and (4) carrying out shape adjustment, weight adjustment and/or coloring on the high-activity artificial breast obtained in the step (5).

In another preferred example, the method of weight adjustment includes: the number of the concave cavities distributed on the back surface of the artificial breast and/or the volume of the concave cavities are adjusted, the used artificial breast raw material is adjusted, and/or the filling material of the artificial breast raw material is adjusted (preferably, the amount of the physiological saline in the filling material is adjusted).

In a second aspect, the invention provides a high-activity artificial breast prepared by the method of the first aspect.

In another preferred embodiment, the artificial breast has a part which can movably coincide with the skin of the chest wall.

In another preferred example, part of the lower surface (i.e. the movably overlapped part) of the artificial breast has no adsorption force and adhesion force to the wearing surface.

In another preferred example, the material of the artificial breast comprises silica gel and filling substance.

In another preferred embodiment, the capsule contains contents.

In another preferred example, the water is normal saline water.

In another preferred embodiment, the filling material is a capsule, and the capsule contains a gas and optionally water.

In another preferred embodiment, the posterior surface (the surface that conforms to the patient) of the breast prosthesis has one or more cavities.

In another preferred example, the concave cavity is a circular concave cavity with the diameter of 2 +/-0.5 cm in cross section, or a circular concave cavity with the diameter of 1 +/-0.3 cm in cross section.

In another preferred embodiment, a circle of adhesive is attached to the periphery of the circular concave cavity with the cross-sectional diameter of 1 +/-0.3 cm.

In another preferred embodiment, the viscose is used to provide adhesion for attaching the artificial breast to the wearing surface.

In another preferred embodiment, the cavity is used for providing physical adsorption force for adsorbing the artificial breast on the wearing surface.

It is understood that within the scope of the present invention, the above-described technical features of the present invention and the technical features described in detail below (e.g., examples) can be combined with each other to constitute a new or preferred technical solution. Not to be reiterated herein, but to the extent of space.

Drawings

Fig. 1 shows a schematic representation of the affected breast.

Figure 2 shows a schematic view of the inferior fold of the affected breast and the frontal contour of the breast.

FIG. 3 is a longitudinal sectional view of the lower half of the affected breast in registration with the chest wall skin (wherein point A represents the location of line A and point B represents the location of line B).

Figure 4 shows a schematic view of the inferior fold location measurement of the affected breast.

Figure 5 shows a schematic view of the positioning of the inframammary fold on a digital model.

FIG. 6 shows a schematic diagram of a process for preparing an artificial breast.

FIG. 7 shows a schematic representation of a digital model after scanning with a very fast 3D infrared scanner, healthy tissue marked with a different color than cut tissue. The healthy side is shown by light color and the affected side by dark color.

Fig. 8 shows the trimming range (left diagram) and the gradient range (right diagram with oblique lines) of the breast prosthesis of the model after scanning, and the diagram shows the back of the breast prosthesis.

Fig. 9 shows a range diagram of the breast prosthesis three-dimensional digital model obtained after the software is built.

Figure 10 shows a 3D printed breast mould (separation membrane not shown).

Figure 11 shows a front and side schematic view of the manufactured artificial breast.

Fig. 12 shows a schematic diagram of the difference between the breast prosthesis not worn and the breast prosthesis worn by the patient.

FIG. 13 shows a schematic side (left) and back (right) view of the breast prosthesis: the side surface of the artificial breast is visible, and a plurality of concave cavities are formed on the surface attached to the body; the back of the artificial breast is the body surface, 2 circles on the periphery are seen to be a concave cavity with the diameter of 1cm, and the inner circle is a concave cavity with the diameter of 2 cm.

Figure 14 shows a schematic diagram of the concavities (i.e., side view of the breast prosthesis: the breast prosthesis concavity depth is 3/4 times the concavity diameter, h-3/4 d), each circular concavity has a depth of 3/4 times the diameter of the circular concavity, represented by a 2cm diameter circular concavity, and has a depth of n-3/4 x2 cm-1.5 cm.

Fig. 15 shows the effect of the artificial breast after being colored.

Fig. 16 shows a schematic of a silica gel air cell of the present invention.

FIG. 17 shows a general procedure for creating a digital model of the breast-filling mold according to the present invention (step (3)).

FIG. 18 shows the general procedure for the creation of the digital model of the affected side breast prosthesis of the present invention (step (2)).

In the drawings, the respective symbols are as follows:

line A: the inferior plica of the affected breast; line B: the front contour line of the affected breast; c, oblique line area: the area where the lower half of the affected breast coincides with the chest wall skin; line D: a horizontal line drawn through the uppermost point of the user's stem;

Detailed Description

The inventor develops a preparation method of a high-activity artificial breast based on collected data and modeling 3D printing, the back of the artificial breast is provided with a cavity, the artificial breast can be perfectly combined with a damaged part of a patient, the artificial breast has the characteristics of soft texture, vivid color, elasticity and the like, and the physical balance of the patient is maintained by wearing the artificial breast. In addition, the invention particularly optimizes the data acquisition of the lower fold of the breast, so that the artificial breast prepared by the method has better activity, and is particularly suitable for manufacturing the artificial breast with the ptosis I type and the ptosis II type. On this basis, the inventors have completed the present invention.

Preparation method of high-activity artificial breast

Referring to fig. 1, the exterior of the breast is classified into the following types: cone type (fig. 1A), hemisphere type (fig. 1B), disc type (fig. 1C), spindle type (fig. 1D), droop I type (fig. 1E), droop II type (fig. 1F). Referring to fig. 2, it can be seen from fig. 2 that, when viewed from the front, the inferior fold of the breast is generally not coincident with the contour line of the front surface of the breast, particularly, the pendulous I-type breast and the pendulous II-type breast, and the pendulous breast is generally formed by placing the inferior fold (shown by the dotted line in fig. 2, i.e., line a) above the contour line of the breast (shown by the implementation of fig. 2, i.e., line B), and the region between the inferior fold and the contour line of the breast (shown by the oblique line in fig. 2, i.e., the region of the oblique line C or C) is generally where the lower half of the breast is coincident with the skin. Since the 3D scanning technique can only record the data at the visible light on the body surface, the data of the breast contour after 3D scanning, that is, the data of line B in fig. 2 and 3, can only be recorded, however, the part between line a and line B is actually the place where the lower half of the patient's breast is attached to the skin of the chest wall. If the information is recorded only according to the contour line (B line) in the process of preparing the artificial breast, the prepared artificial breast has poor activity, and has no certain activity and poor simulation degree like a healthy real breast.

The invention can efficiently and quickly manufacture a more ironing artificial breast aiming at a patient through a digital technology and precise calculation, and the weight of the artificial breast is close to the weight of breast tissues which are not cut, thereby achieving the effect of maintaining the body balance and coordination. Particularly, in the step of manufacturing the model, the diaphragm is added in the model, so that the manufactured artificial breast has certain mobility and better simulation effect. The invention can solve the problems of poor activity degree of artificial breast and poor simulation effect which are puzzled on modern medicine and plastic aspect.

In the method for preparing the artificial breast, the body surface information of the user is obtained through 3D scanning, the subsequent model establishment is carried out based on the obtained 3D digital data, and the corresponding information of other body surfaces of the user is obtained through measurement so as to determine the position of the inferior breast fold in the artificial breast model.

In one embodiment, referring to fig. 4, the data required to make the diaphragm for the model (the infrafold position data) is obtained by the following method:

a horizontal line (D line) is drawn along the uppermost point of the sternum stem of the patient, and a vertical underline is drawn along the D line at a distance (e.g. every 0.5-1.5cm, such as every 1cm) outwardly from the midline of the sternum, where the intersection of the underline and the D line is point D_nThe corresponding intersection of the vertical line with the inferior plica (i.e., point x)_n) Is x₁，x₂， x₃，x₄，x₅… …, measuring the distance (i.e., h) from the line D to the inferior fold (i.e., line A)_n) And records the data h₁，h₂，h₃，h₄，h₅……。

In one embodiment, referring to fig. 5, the obtained infrafold data is introduced into the scanned digital model by: likewise, a horizontal line (line D) is drawn along the uppermost point of the sternum stem of the patient, and a vertical underline is drawn along line D at intervals (e.g., every 0.5-1.5cm, such as every 1cm) outwardly from the midline of the sternum, in terms of h₁，h₂，h₃，h₄，h₅… … the intersection of the equal length positioning vertical line and the inferior plica is x₁，x₂，x₃，x₄，x₅… …, and then x1, x2, x3, x4, x5 … …, etc. are connected and wait to line A, which is the inferior fold of the user.

The female mould and the male mould of the artificial breast obtained by the technology of digitally manufacturing the artificial breast are represented by discrete digital triangular units, and 3D printing processing can be directly output.

Generally, the general process for preparing a breast prosthesis is shown in fig. 6, and includes the acquisition of required data, the design of a digital mold for the breast prosthesis based on the acquired data, and the 3D printing of the mold. The mold is poured to obtain the artificial breast.

In one embodiment, the present invention provides a method for preparing a high-activity artificial breast, comprising the steps of:

1.1.3D digital data acquisition:

3D scanning the shape of the healthy side breast of the user to obtain 3D data of the healthy side breast, wherein the data is 3D digital data.

Data acquisition mainly adopts a top-speed 3D infrared scanner, and parameters used for scanning are shown in table 1:

TABLE 1


				Time of scan	1ms-15ms	Spotlight light source	730nm infrared light source
Time of imaging	20s-30s	Imaging technique	Multi-viewpoint three-dimensional technology
				Suggesting scanning object dimensions	650mm650mm650mm	Data interface	USB2.0/3.0
Scanning range	Chest and underarm	Number of cameras	4 black and white +2 color
				Accuracy of scanning	0.1mm	Horizontal angle of chest scan	180°-200°
Resolution of mapping	200/500/1000/1600p (optional)	Output format	OBJ，STL，OFF，PLY
				Model splicing mode	Full-automatic splicing	Distance of space points	0.5-1mm
Number of breast molding scans	One-step forming	System support	win7，Win10
				Printable data output	Support for

1.2. Collection of inferior plica data (i.e. measuring user body surface data)

Referring to FIG. 4, a horizontal line (line D) is drawn along the uppermost point of the patient's manubrium; along the line D, vertically underlining every 0.5-1.5cm (preferably 1cm) from the midline of the sternum (wherein the intersection point of the vertical underlining line and the line D is point D, and points D are sequentially marked as D₁、D₂、D₃、D₄、D₅……)；

Measuring the distance from the line D to the inferior plica (i.e., measuring the length between the point D on each vertical underline and the intersection of the underline and the inferior plica), data h is recorded₁、h₂、h₃、h₄、……h_nThe intersection of this vertical line with the inferior fold is recorded as x₁、x₂、x₃、x₄、……x_n(i.e., intersection x)_m)。

Intersection x of these underlines with the infraplica_mCan be determined from the distance from point D to the midline of the sternum and the distance from line D to the inferior plica; the distance from each point D to the median line of the sternum is respectively recorded as Lc and L₂、L₃、L₄、…… L_nThen each intersection may be defined by a data pair (L)_m，h_m) Determination of, i.e. x₁(L₁，h₁)、x₂(L₂，h₂) … … are provided. Wherein, the data pair (L)_m，h_m) I.e. the desired crease line data.

2. Establishing an affected side breast prosthesis model:

2.1 establishing a preliminary digital model of the Artificial breasts

As shown in fig. 18, based on the 3D digitized data, a digitized model of the healthy lateral breast and a central sagittal plane of the digitized model are established; and, the healthy breast model is subjected to mirror image conversion and trimming relative to the central sagittal plane, so as to obtain a breast prosthesis digital model (namely a preliminary digital model which does not show the correct inferior plica position) which is preset on the affected side, and the preliminary digital model of the breast prosthesis comprises a line B representing the front outline of the lower half part of the breast; wherein the digital model of the healthy breast and the digital model of the artificial breast at the affected side are basically or completely symmetrical left and right.

The design of the artificial breast is based on scanning data, a central sagittal plane is established, and the healthy breast is turned to the affected side in a mirror image mode. The mirrored breast tissue is further adjusted to a left-right symmetric position using position adjustment tools such as rotation, translation, etc. of the software. In the software, all tissue models that were missing after the operation on the affected side relative to the healthy side were obtained by a boolean operation tool, and all tissue models are shown in fig. 7.

2.2 creating a digitized model of the prosthesis including the inferior plica (line A)

On the preliminary digitized model obtained in step 2.1, as shown in FIG. 5, a horizontal line (D line) is also drawn along the uppermost point of the sternal pedicle of the patient, and a vertical underline is drawn vertically downwards (i.e., at an interval of L of step 1.2) every 0.5-1.5cm (at the same underline interval as step 1.2) from the midline of the sternum along the D line₁、L₂、L₃、L₄、…… L_nDetermine points D on line D and vertically underline points D), according to h₁、h₂、h₃、h₄、…… h_nEqual length location of the intersection x of the vertical line and the inferior plica_mIs x₁、x₂、x₃、x₄、……x_n(according to the data pair (L)_m，h_m) Determining a point x on the A line_m) (ii) a Then x is put₁、x₂、x₃、x₄、……x_n(i.e., each intersection point x_m) And then connected to provide line a (i.e., the patient's inferior fold). Thereby resulting in a digitized model of the prosthesis including the inferior plica (line a).

2.3 pruning of the digitized model of the Artificial Breast

The resulting digitized model of the breast prosthesis including the inferior plica is trimmed by the software.

Generally, the operation of breast diseases can be broadly divided into two types: benign surgery and malignant surgery.

In one particular embodiment, referring to fig. 8, the range of the model to be trimmed for benign and malignant surgery is specified as:

up to 2 + -1 cm (preferably 2 + -0.5 cm, more preferably 2 + -0.1 cm) below the clavicle, i.e. the upper (superior) edge;

the medial side to the midline of the clavicle at a distance of-1 to 0cm (preferably-0.5 to 0cm, more preferably-0.1 to 0 cm), wherein "-" means a distance not reaching the midline of the clavicle), i.e., the position of the inner edge (or medial side );

down to 2cm + -1 cm (preferably 2 + -0.5 cm, more preferably 2 + -0.1 cm) below the inframammary fold, i.e. the position of the lower edge (or underside); and

the lateral to posterior axillary line + -1 cm (preferably + -0.5 cm, more preferably + -0.1 cm), i.e. the outer margin (position of the lateral side).

The upper, inner and lower edges of this range are gradually changed to the inner circle by 1 + -0.1 cm, and the outer edge is gradually changed to the inner circle by 2cm (i.e. 2 + -0.2 cm inward of the posterior axillary line), as shown in the diagonal portion of the right diagram of fig. 8. The term "tapering region" refers to a region in which the breast prosthesis is gradually thinned, and the upper and lower inner and outer edges of the breast prosthesis can be smoothly joined to the surrounding skin tissue.

In another preferred embodiment, the upper edge is located 2cm below the clavicle, the inner edge is located above the mid-clavicle line, the lower edge is located 2cm below the infra-mammary fold, and the outer edge is located at the posterior axillary line; and the range from 2-3cm below the clavicle, the range from the median line of the sternum to 1cm inside the median line, the range from 1-2cm below the infraatrial fold, and the range from the posterior axillary line to 2cm inside the posterior axillary line are the gradual change ranges.

Generally, the outside, i.e. the posterior axillary line, has more defective tissues, and the gradual change range of 1cm can cause the appearance to be too abrupt and easily cause discomfort for patients; therefore, the gradual change range of the outer edge of about 2cm or more is particularly adopted in the method, so that the appearance of the artificial breast prepared by the method is not sharp, and discomfort of a wearer is not easy to cause. Therefore, the pruning range and gradual range selected by the invention can not only simulate the real breast appearance but also complement the deficiency of the axillary tissues by the artificial breast prepared by the method of the invention after malignant operations (such as axillary lymph node cleaning operation which causes the deficiency of the axillary tissues).

For the reconstruction of the appearance in the range, the appearance of the affected side of the patient after operation is finally restored by 100 percent. The final three-dimensional digital model of the artificial breast is obtained by the above trimming, as shown in fig. 9.

3. Establishment of digital model of breast model

As shown in fig. 17, a digitized model of a digitized breast prosthesis mold is created based on the digitized model of the affected side, a digital parting plane is created for the digitized model of the breast prosthesis mold, a mold box is created, and the digitized model is split, i.e., split into a male mold digitized model and a female mold digitized model, and three-dimensional digital models of the female mold cavity and the male mold cavity are saved as a common STL format file as an input file for 3D printing.

Preferably, the digital model includes a separating membrane for forming a movable repeat of the breast prosthesis and the chest wall skin (simulating the fit or registration of the pendulous type I and/or pendulous type II breasts with the chest wall skin).

Preferably, the shape of the separation membrane is determined by lines a and B, i.e., the separation membrane is established in the region C as shown in fig. 4.

4. Making of breast model

And forming a printed breast prosthesis male mold and a breast prosthesis female mold through 3D printing based on the male mold digital model and the female mold digital model.

Using Medvance SLA450, with its own preprocessing software, the STL file of the mold was imported, the support added, and the cut sheet was printed. The material used for 3D printing is a general photosensitive resin material. The printed mold is shown in fig. 10.

5. Trimming and/or finishing breast mould

Trimming and/or modifying the breast prosthesis mould: and (3) grinding and polishing, and performing irregular stripe and dot-shaped depression treatment on the nipple areola of the female mould part to simulate the physiological texture of the surface of the nipple areola. Alcohol disinfection, so as to obtain the high-mobility breast mould.

6. Preparation of artificial breast

Pouring medical silica gel, and taking out the artificial milk product from the mould after the silica gel is solidified, as shown in figure 11.

The medical silica gel has the characteristics of excellent electrical property and chemical stability, water resistance, ozone resistance, weather aging resistance, no corrosiveness, physiological inertia, no toxicity and no odor, passing SGS and ROSH environment-friendly and non-toxic certification, being capable of being used for a long time at the temperature of-65-200 ℃ and keeping the soft and elastic property thereof, low linear shrinkage rate, easy operation and the like. Can be used for manufacturing flexible silicon rubber products such as human organs, human body shapes, breast pads, shoulder pads, patches, non-slip pads and the like.

The operation method of the medical silica gel comprises the following steps:

(1) uniformly mixing the silica gel (A) and the curing agent (B) according to the ratio of 1: 1;

(2) pouring for 30 minutes after vacuum defoaming;

(3) vulcanizing at 10-40 deg.C for 2-3 hr, or at 80-120 deg.C for 10 min;

(4) coloring medical silica gel.

Parameters of the medical silica gel:

in another preferred example, the silicon capsule body is put in the process of filling the medical silica gel.

Preferably, the content of the silicon capsule body is gas or gas and normal saline.

7. Improvement of breast prosthesis

After the patient wears the shoes, the shoes are properly adjusted according to the wearing effect and the feeling of the patient, and the adjustment comprises the appearance and the color weight.

7.1 aspect of the shape

In the aspect of appearance, the range of the artificial breast three-dimensional digital model can be properly adjusted according to the actual wearing condition of the patient.

For the operation aiming at the diagnosis of malignant disease, the following operations can be classified in terms of the scope of the operation: 1. the method comprises the following steps of (1) mammary gland local enlargement excision and sentinel lymph node biopsy, 2) breast simple excision and sentinel lymph node biopsy, 3) mammary gland local enlargement excision and axillary lymph node cleaning, 4) breast simple excision and axillary lymph node cleaning, 5) breast simple excision, pectoralis minor muscle excision and axillary lymph node cleaning, and 6) breast simple excision, pectoralis major muscle excision, pectoralis minor muscle excision and axillary lymph node cleaning.

In the above 6 operations, 1 and 3 may cause partial breast defect and axillary tissue defect, while the other operations (2, 4, 5, 6) may cause the defect of the whole breast and the defect of the axillary tissue, and all the operations 3, 4, 5, 6 include axillary lymph node cleaning, and some operations even include small pectoralis muscle and large pectoralis muscle (e.g. operations 5 and 6) because the scope of the axillary cleaning includes the whole axillary vein, all the adipose tissues and the lymphatic tissues below the subclavian vein, and thus, the axillary lymph node cleaning actually causes a large amount of tissue defect. Therefore, the artificial breast can be properly adjusted according to the actual wearing condition of the patient, and more importantly, the range of the three-dimensional digital model of the underarm part is adjusted.

Based on the bulge of the male die, the artificial breast obtained by glue pouring is attached to the surface of the body and is fully distributed with circular concave cavities with the diameter of 1cm and 2cm, 2 circles of the periphery are circular concave cavities with the diameter of 1cm, and the inner circle is a circular concave cavity with the diameter of 2 cm. The four corners are positioning points with the diameter of 0.5cm and are used for positioning: the median line of the sternum is shown in fig. 13, the upper and lower ends, the anterior axillary line and the posterior axillary end. The depth of each circular cavity is 3/4 times the diameter of the circular cavity to ensure sufficient negative pressure during wear, as shown in figure 14.

7.2 color aspect

In order to make the appearance more vivid, the silica gel is colored according to the skin color of a patient, so that the appearance is copied, the color is completely copied, and the overall restoration of the whole appearance is achieved.

Coloring the silica gel: the special pigment for coloring outside the silica gel is an oily pigment, and has the characteristics of simple operation, no toxicity, high drying speed, no fading and the like. The color can be freely adjusted, the color of the silica gel can be coated on the surface of the silica gel for about 30 minutes, and the silica gel is dried completely for 24 hours. After drying thoroughly, the hand can not be touched and the stretching can not be cracked. Can be colored by a spray gun, and the spray gun is used after being blended by a diluent.

The operation method comprises the following steps:

firstly, the adhesive is extruded out of the container.

② taking out a proper amount of the color, adding the color into the adhesive, and stirring the mixture evenly.

And thirdly, if the painting is carried out by a spray gun, a proper amount of diluent can be added for dilution, and the paint can be directly applied without dilution.

Fourthly, drying for about 24 hours after coloring, stretching by hands after drying, not losing color, and being capable of draining.

After the spray gun finishes spraying, the spray pen can be cleaned by diluent, and the used container can be torn off after the color is dried.

The effect of coloring the artificial breast is shown in fig. 15.

7.3 weight aspects

The density d of the solid silica gel is first calculated by the following two calculation methods: the method comprises the following steps: pouring liquid silica gel into a container with the capacity of 1ml, solidifying and weighing, wherein the density d of the solid silica gel is equal to weight/1 ml; the second method comprises the following steps: the solid artificial milk is made, weighed as w, and is immersed in a container filled with water, and the volume v of the artificial milk is calculated by the volume of the overflowed water, and the density d is w/v.

Secondly, the volume of the entity artificial breast is calculated, and the two calculation methods are as follows: the method comprises the following steps: calculating the volume of the object in any shape through a computer; the second method comprises the following steps: the solid artificial breast is printed by using common resin material, and is immersed into a container filled with water, and the volume of the artificial breast is calculated by the volume of the overflowed water.

After the patient wears the solid breast prosthesis, the weight of the patient is W1, the weight of the patient before the operation is W2, and in order to achieve 100% recovery of the breast prosthesis, W1-W2 is 0. When W1> W2, the design of a concave cavity needs to be carried out on a female die of the artificial breast, and the total volume of the concave cavity is as follows: (W1-W2)/d, the cavity depth being 3/4 times the cavity diameter.

The volume of the cavity with the diameter of 2cm is calculated as follows: (4/3) π 1^3- [ π 1^2 ^ 0.5-1/3 π (1^3- (1-0.5) ^3), i.e., cavity volume 3.5343cm with a diameter of 2cm³。

The volume of the cavity with the diameter of 1cm is calculated as follows: (4/3) pi 0.5^3- [ pi 0.5^2 ^ 0.25-1/3 pi (0.5^3- (0.5-0.25) ^3)]I.e. a cavity volume of 0.4418cm with a diameter of 1cm³。

And designing a cavity of the artificial breast based on the difference between the quality of the artificial breast obtained by glue filling and the real quality of the breast of the human body, and obtaining the final individuation.

The effect of the user after wearing is shown in fig. 12.

The main advantages of the invention include:

the prepared breast prosthesis can restore the shape of the affected breast, particularly the axilla and the whole chest, achieves the restoration degree close to 100 percent (98 percent to 100 percent) of the healthy breast, simultaneously ensures that the postoperative breast of a patient is symmetrical left and right, and has the functions of benefiting health.

(1) The method is particularly suitable for preparing the prolapsed I-type and prolapsed II-type artificial breasts.

(2) The artificial breast prepared by the method has higher activity.

(3) The artificial breast prepared by the method not only can simulate the breast and the fat tissue around the breast, the oxter fat tissue and the lymph nodes in the operation range, but also can simulate the muscle atrophy part caused by lack of movement, and can restore the shape of 100% according to the will of a user.

(4) In one embodiment, the method of the invention also allows for adjusting the weight of the breast prosthesis to simulate the true breast weight (e.g., by a silicone bladder);

in particular, the silica gel air bag can be filled with a certain amount of physiological saline, the weight of the air bag is further adjusted by different volumes of physiological saline, and the change of the breast in different positions can be more vividly simulated by the flowability of the physiological saline.

The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are only for illustrating the present invention and are not intended to limit the scope of the present invention. The experimental procedures, in which specific conditions are not noted in the following examples, are generally carried out under conventional conditions or conditions recommended by the manufacturers. Unless otherwise indicated, percentages and parts are percentages and parts by weight.

Example 1: solid artificial breast

1: and (4) polishing and polishing the 3D printed breast prosthesis mould, and disinfecting by using alcohol.

2: and pouring safe silica gel, and taking out the silica gel from the mold after the silica gel is solidified to obtain the artificial breast product with better activity.

Example 2: solid silica gel and gas artificial breast

The main body is silica gel of the outer layer, and the inner layer is an oblate silica gel air bag, as shown in fig. 16.

In the process of injecting the artificial breast, the oblate silica gel air bag is placed in the liquid silica gel and then is solidified into the finished artificial breast product. The oblate silica gel air ball can be made into different sizes, the diameter is 5-10cm, and the height is 1-2 cm.

Example 3 solid silica gel + physiological saline + gas Artificial milk

The preparation method is basically the same as the embodiment 2, and is different in that the normal saline with different weights is injected into the cavity of the silica gel air sac, then the silica gel air sac is placed in the liquid silica gel, and then the liquid silica gel is solidified to form the finished product of the artificial breast.

The breast prosthesis of this embodiment also has the following main advantages: the weight of the artificial breast can be adjusted by physiological saline with different milliliters, so that the adjustment of the weight is more accurate; in addition, the normal saline is liquid and is arranged in the inner layer of the artificial breast, and the flowing performance of the liquid can more vividly imitate the state of the breast in different positions to achieve better effect.

In addition, in the finished artificial breast, the physiological saline in the silica gel air sac cavity is increased or reduced by using the medical injector, so that the restriction of adjusting the weight of the artificial breast is less and more convenient.

All documents referred to herein are incorporated by reference into this application as if each were individually incorporated by reference. Furthermore, it will be appreciated that various changes or modifications may be made by those skilled in the art after reading the above teachings of the invention, and such equivalents will fall within the scope of the invention as defined in the appended claims.

Claims

1. A method for preparing a high-activity artificial breast, which comprises the following steps:

(1) acquisition of 3D digitized data of breast contour and inferior fold data

(1.1) acquiring 3D digital data;

performing 3D scanning on the shape of the postoperative healthy breast or preoperative affected breast of the user to obtain 3D data of the healthy breast, wherein the data are 3D digital data;

(1.2) collecting inferior fold data;

(1.2.3) measuring the distance h from each point D to the line A along the vertical direction respectively and recording the distance h as h₁、h₂、……h_n(ii) a And

(1.2.4) data (L)_m，h_m) I.e. required wrinkle line lowering data, wherein m represents any integer from 1 to n;

(2.1) establishing a preliminary digital model of the artificial breast;

(i) establishing a digital model of the postoperative healthy lateral breast and a central sagittal plane of the digital model based on the 3D digital data; and, relative to the central sagittal plane, carrying out mirror image conversion on the health-side breast digital model so as to obtain a preliminary digital model of the artificial breast preset on the affected side; wherein the digital model of the healthy breast and the preliminary digital model of the affected breast are substantially or completely bilaterally symmetric; or, (ii) based on the 3D digital data, establishing a digital model of the affected breast before operation, thereby obtaining a preliminary digital model of a prosthesis preset on the affected side; wherein the digitized model of the preoperative affected breast and the preliminary digitized model of the affected breast are substantially or completely overlapped;

(2.2.1) determining a topmost point of a bone shank in the preliminary digital model, and establishing a D line based on the topmost point of the bone shank;

(2.2.2) based on the uppermost point of the pedicle, D-line and the data pair (L) obtained in step (1.2.4)_m，h_m) Determining each point x in said preliminary digitised model_mI.e. determining x₁、x₂……x_n(ii) a And

(4) manufacturing a breast prosthesis mould:

(5) preparing artificial breast;

2. The method of claim 1, wherein in step (1.2.2), 5-40 points D are taken on the D-line.

3. A method as claimed in claim 1, characterized in that the distance between adjacent points D or D₁The distance to the median line of the sternum is 0.25-1.5 cm.

4. The method of claim 1, wherein the separation film is used to form a coincident attachment portion of the breast prosthesis simulating a real breast and chest wall skin.

5. The method of claim 1, wherein the milk replacer is selected from the group consisting of: (i) a silica gel feedstock, or (ii) a combination of a silica gel feedstock and a filler material.

6. The method of claim 1, further comprising the step of: (6) improving artificial breast;

7. A highly active artificial breast, wherein the artificial breast is prepared by the method of claim 1.

8. The highly active breast prosthesis of claim 9, wherein a portion of the lower surface of the breast prosthesis is free of adsorptive and adhesive forces to the wearing surface.

9. The highly active artificial breast of claim 9, wherein the material of the artificial breast comprises silica gel and a filler substance.

10. The high activity prosthesis of claim 9, wherein the posterior surface of the prosthesis has one or more cavities.