CN108447370A - It imitates the prosthese of lesion breast and its designs with preparation method, to the method for human breast lesion detection device optimization or check and correction - Google Patents

It imitates the prosthese of lesion breast and its designs with preparation method, to the method for human breast lesion detection device optimization or check and correction Download PDF

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CN108447370A
CN108447370A CN201810394619.3A CN201810394619A CN108447370A CN 108447370 A CN108447370 A CN 108447370A CN 201810394619 A CN201810394619 A CN 201810394619A CN 108447370 A CN108447370 A CN 108447370A
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prosthese
lesion
breast
site
human breast
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CN108447370B (en
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冯雪
陈颖
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Tsinghua University
Institute of Flexible Electronics Technology of THU Zhejiang
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Tsinghua University
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    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine

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Abstract

The present invention relates to a kind of prostheses imitating lesion breast and its design with preparation method, to the method for human breast lesion detection device optimization or check and correction.The prosthese of imitation lesion breast in the present invention, the wherein prosthese include prosthese main body and the simulation lesion site in prosthese main body.Prosthese main body is formed by the material of main part of apery body normal galactophore tissue, and it has the shape for imitating human breast.It includes one or more physics fever sites and/or one or more chemical modifications site to simulate lesion site, physics fever site is formed by flexible heating device, and the flexibility heating device has lead, wherein the flexible heating device of lead one end connection, the optionally other end expose from prosthese bottom part body.

Description

It imitates the prosthese of lesion breast and its designs with preparation method, to human breast lesion Detect device optimization or the method for check and correction
Technical field
The invention belongs to medical professionals's binding field, it is related to a kind of prosthese imitating lesion breast, imitates lesion breast The design of prosthese and preparation method and the method to human breast lesion detection device optimization or check and correction.
Background technology
Female mammary gland is made of skin, fibr tissue, corpus mamma and fat, and breast cancer is to be happened at breast epithelium The malignant tumour of tissue.Breast cancer has become one of the major malignant tumor for threatening women's health, and incidence is in female tumor In ranked first, and it is in rising trend.Breast cancer has become the great public health problem of current social.
The prevention and treatment method of breast cancer can simply be attributed to physics class, chemical classes and the two and combine.Physics class Method extensively using sound, light, power, electricity, the physical principles such as heat to the early screening of breast cancer, clinical diagnosis and treatment with it is postoperative Medical assistance etc. played an important role.By taking breast cancer early detection as an example, clinically use at present and grinding The method studied carefully includes:X-ray imaging, ultrasonic imaging, thermal imaging etc..The pathologic basis of these judgment methods is compared to normal group It knits, sick cell and tissue metabolism are more vigorous so that diseased region local physical property (including hardness, temperature) and physiology Tissue topography changes.
Threat due to the high incidence of breast cancer and its to women's health and living standard, with novel electron technology Development and the foundation of Novel medical pattern, develop it is portable, wearable, long term monitoring or the medical treatment & health of breast cancer can be treated set It is standby to realize that tele-medicine already becomes trend and hot spot with personalized medicine.In being studied for the electronic device of breast cancer medical treatment The prosthese that human lesion mammary gland physical characteristic can accurately be imitated is most important for the value of extracorporeal simulating experiment.Lesion breast is false Body is the variation of tissue substance reason characteristic in part when referring to simulation human breast lesion, including localized hyperthermia, local elasticity's modulus Increase and indicative of local optical properties change etc..
However, existing breast prosthesis is substantially to be repaired for the breast after tumor resection at present, to improve Curative effect is treated in tumor radical cure shaping and beauty, and quality of making the life better reduces medical treatment cost.It is based on for example, having been recorded in patent document 1 The breast prosthesis manufacturing method of three-dimensional printing technology, wherein treating excision according to the mammary gland medical image data of patient in the preoperative Tumour carries out analyzing and positioning, determines shape, the size and location of cut-out, further utilize biological three-dimensional printing technology according to Model prepares satisfactory personalized breast prosthesis.However, for breast prosthesis can be used for can long term monitoring or treatment breast The medical treatment & health equipment of gland cancer is recorded there is no further.
Therefore, the sky that breast prosthesis carries out complementary medicine research, the precision of detection mode is also further promoted is utilized Between.
Patent document 1:CN 104783924A
Invention content
Problems to be solved by the invention
Insufficient present on for this field, the technical problems to be solved by the invention are to be controlled to towards breast cancer monitoring The research for the treatment of provides reliable experiment in vitro carrier, easily can optimize school with instrument to human breast location detection It is accurate.
Prosthese based on 3D printing and flexible electronic Technology design and the imitation lesion breast prepared in the present invention has can The function of the imitation human breast leaned on.Further, by using the prosthese for preparing of the present invention as experiment in vitro carrier, it can be achieved that Accurate simulation and dynamic control of the lesion locations with lesion intensity, thus obtain the definite information about " lesion " degree, in turn Personalization is carried out according to these information, is targetedly treated.
In addition, the present invention also aims to provide a kind of preparation method for the prosthese imitating lesion breast, it thus can root According to the specific disease of patient, customization individual character particularly imitates the prosthese of lesion breast, the development shape of long term monitoring breast cancer Condition or treatment breast cancer.
In addition, the present invention also aims to provide a kind of side to human breast lesion detection device optimization or check and correction Method.Using the prosthese for imitating lesion breast as experiment in vitro carrier, units test is detected by novel human-body breast lesion and is somebody's turn to do The information such as calorifics, the mechanics of prosthese, and further compared, thus optimized or proofreaded with the true detection data of the prosthese Novel human-body breast lesion detects device.This method is to developing novel medical device and theoretical model for breast cancer with weight Want meaning.The present invention can be used for but be not limited to the verification of the design and optimization and novel theoretical model of Novel electronic devices.
The solution to the problem
The present invention is based on 3D printing and flexible electronic technology, propose a kind of lesion breast prosthesis design and preparation method and The thus obtained prosthese for imitating lesion breast.Especially by implementation of such as getting off.
Technical solution of the present invention is as follows:A kind of prosthese imitating lesion breast, the prosthese includes prosthese main body, and packet The simulation lesion site being contained in prosthese main body, wherein
The prosthese main body is formed by the material of main part of apery body normal galactophore tissue, and it has imitation human breast Shape;
The simulation lesion site includes one or more physics fever sites and/or one or more chemical modifications position Point,
Physics fever site is formed by flexible heating device, and the flexible heating device has lead, wherein The flexible heating device of lead one end connection, the optionally other end expose from the prosthese bottom part body.
According to above-described prosthese, wherein the material of main part of apery body normal galactophore tissue includes soft silica gel material Material.
According to above-described prosthese, wherein the flexibility heating device includes micro-nano electronic device, the micro-nano electronics There is device functional layer, the functional layer to include at least fuel factor functional layer.
According to above-described prosthese, wherein the prosthese has the one-dimensional heat conduction material of topological structure distribution, with mould The form of anthropomorphic body mammary vascular distribution and arrange, the optionally at least one-dimensional heat conduction material of part is from the prosthese main body Expose bottom.
Another technical solution of the present invention is as follows:A kind of preparation method for the prosthese imitating lesion breast, the method packet Include following steps:
A) the step of forming the mold with human breast shape;
B) the step of forming the prosthese for imitating lesion breast in the mold,
The prosthese includes prosthese main body, and the simulation lesion site in prosthese main body, wherein
The prosthese main body is formed by the material of main part of apery body normal galactophore tissue, and it has imitation human breast Shape;
The simulation lesion site includes one or more physics fever sites and/or one or more chemical modifications position Point,
Physics fever site is formed by flexible heating device, and the flexible heating device has lead, wherein The flexible heating device of lead one end connection, the optionally other end expose from the prosthese bottom part body.
According to the process described above, wherein forming the mold using 3D printing method in the step a).
According to the process described above, wherein the step b) includes the following steps:
I) liquid-state silicon gel precursor material is partially filled with into the inverted mold, it later will be before the liquid-state silicon gel Body material solidification obtains soft silica gel material;
Ii) in the fixed one or more physics fevers site and/or one of above-mentioned soft silica gel material surface forming position A or multiple chemical modifications site,
Repeat above-mentioned steps i) and ii), until the usable part of mold is filled, each soft silica gel material Entirety form the prosthese main body.
According to the process described above, wherein in step ii) in, form the flexible heating device in physics fever site Physics fits in the soft silica gel material surface in a manner of negative pressure and/or the chemical modification site passes through to described soft Matter silica gel material surface carries out chemical modification processing and is formed.
Include being swept to the detection of the lesion breast of real human body wherein before step a) according to the process described above It retouches, the detection scanning includes the specific location and volume of the shape and lesion that determine the true lesion breast.
According to the process described above, wherein being set according to the specific location of lesion and volume determined by the detection scanning Set position and the volume of the simulation lesion site in the prosthese.
Further include that setting in the mold has wherein between step a) and step b) according to the process described above There is the step of one-dimensional heat conduction material that topological structure is distributed, is arranged in the form of simulating human breast vascular distribution, optionally At least part of one-dimensional heat conduction material exposes from the prosthese bottom part body.
The another technical solution of the present invention is as follows:A method of to human breast lesion detection device optimization or check and correction, It includes the following steps:
The step of preparing to imitate the prosthese of lesion breast, the prosthese are according to above-described prosthese or according to above The prosthese that the method obtains;
The step of obtaining the true detection data of the prosthese;
The prosthese is tested using to be optimized or check and correction human breast lesion detection device to obtain test number According to the step of;
True detection data and the test data are compared, and then optimizes or proofread the human breast lesion detection device The step of.
According to the process described above, wherein the true detection data and/or test data include thermal data, mechanics Data, optical data or combinations thereof.
The effect of invention
Technical solution based on disclosure provided above, present invention obtains advantageous technique effects:Through the invention The prosthese of the imitation lesion breast of offer can provide reliable experiment in vitro for the research towards breast cancer monitoring treatment and carry Accurate simulation and dynamic control of the lesion locations with lesion intensity further can be achieved in body.In addition, pathomimia through the invention Become the preparation method of the prosthese of breast, can according to the specific disease of patient, the state of development of long term monitoring breast cancer or Treat breast cancer.In addition, the method to human breast lesion detection device optimization or check and correction through the invention, can optimize or school It, thus can design and optimization Novel electronic devices and the novel theoretical model of verification to novel medical device.
Description of the drawings
Fig. 1 is the schematic diagram of lesion breast prosthesis structure involved in the present invention.
Fig. 2 is the schematic cross-section of micro-nano electronic device used in lesion breast prosthesis involved in the present invention.
Fig. 3 is the schematic diagram of micro-nano electronic device deformable structure used in lesion breast prosthesis involved in the present invention.
Fig. 4 is the preparation flow of lesion breast prosthesis involved in the present invention.
Fig. 5 is the application schematic diagram of lesion breast prosthesis involved in the present invention in vitro experiment.
Reference sign
In figure, 1- material of main parts;2- micro-nano electronic devices;Material of main part (chemical modification positions of the 3- Jing Guo chemical modification Point);4- one-dimensional heat conduction materials;5- micro-nano electron device package layers;6- micro-nano electronic device functional layers;6a- serpentine curves;6b- Extraction wire;7- micro-nano electronic substrate layers;8-3D printer nozzles;9- imitates Breast model;10- heating plates;11- testers Part.
Specific implementation mode
To make the object, technical solutions and advantages of the present invention clearer, below in conjunction with attached drawing to embodiment party of the present invention Formula is described in further detail.
<First embodiment>
The prosthese of lesion breast is imitated with preparation based on 3D printing and flexible electronic Technology design.
The first embodiment of the present invention provides a kind of prosthese imitating lesion breast comprising prosthese main body and packet The simulation lesion site being contained in prosthese main body.Specifically, as shown in Figure 1, the prosthese for imitating lesion breast includes prosthese main body 1 With simulation lesion site 2,3.Prosthese main body 1 is formed by the material of main part of apery body normal galactophore tissue, and it has imitation The shape of human breast.
It includes one or more physics fever sites 2 and/or one or more chemical modifications site 3 to simulate lesion site. Specific to Fig. 1, physics fever site 2 is formed by flexible heating device, and the flexibility heating device has lead, wherein described draw The flexible heating device of line one end connection, optionally, the other end exposes from the prosthese bottom part body.
The feature of prosthese for imitating lesion breast includes mainly:1) human breast pattern is imitated;2) the internal substance filled point Two classes, an analoglike human normal breast tissue, another kind of simulated lesion breast tissue;3) object of apery body normal galactophore tissue It is similar with human breast physical characteristic to manage characteristic, including elasticity modulus, thermal conductivity, imitates physical characteristic and the people of lesion breast tissue Body lesion breast tissue physical characteristic is similar;4) the volume size and spatial position distribution for imitating lesion breast tissue can accurately dynamically Control.
Prosthese main body 1 has the shape for imitating human breast.In the present invention, human breast is carried out using 3D scanning techniques Scanning, establishes breast pattern threedimensional model, further prints the hard ghost with breast pattern using 3D printing technique, obtain To imitative Breast model.Prosthese main body is formed in thus obtained imitative Breast model.
Prosthese main body mould personification body normal galactophore tissue, is formed by the material of main part 1 of apery body normal galactophore tissue.Apery The physical characteristic of body normal galactophore tissue is similar with human breast physical characteristic, including elasticity modulus, thermal conductivity etc..Apery body is just The material of main part 1 of normal breast tissue preferably includes soft silica gel material.Soft silica gel material can be consolidated by the silica-gel composition of liquid Change and obtains.For example, high elastic polymer material usually can be used, such as silica gel PDMS,Dragonskin and The materials such as hydrogel.
The polymer material of apery body normal galactophore tissue is not particularly limited in the present invention, can use be obtained commercially Those of.For example, PDMS (dimethyl silicone polymer) is recognized under normal circumstances as a kind of the macromolecule organic silicon compound It is nontoxic to be inertia, nonflammable, chemical stabilization.00-30,00-20,00-10 and 00-50 etc. are platinum catalysis systems The especially soft silicon rubber made, hardness can be adjusted freely as needed.
By adjusting the concrete composition of polymer material, thermodynamic parameter (such as heat conduction of the material of main part after solidification can be made Coefficient, thermal capacitance etc.) organized as far as possible with human breast average thermodynamic parameter similar or elasticity modulus as far as possible with human breast Organize average elastic modulus close.As far as possible reach prosthese main body real surface when testing the performance parameter of pathological tissues in this way The situation of human breast's tissue, keeps the background noise from prosthese main body as small as possible.
It includes one or more physics fever sites 2 and/or one or more chemical modifications site 3 to simulate lesion site. It simulates lesion site and imitates lesion breast tissue, physical characteristic is similar with human lesion breast tissue physical characteristic.Physics is sent out Thermal potential point is mainly formed by flexible heating device.Flexible heating device preferably includes micro-nano electronic device 2.
Micro-nano electronic device 2 has following characteristics:With fuel factor, its fuel factor can be controlled by circuit accurate quantification Heat generates;Has flexible and ductility, unobvious change the mechanical property of lesion breast prosthesis entirety, can be deformable It is worked normally in measuring environment;With with the approximate thermodynamic parameter of material of main part, it is whole that unobvious change lesion breast prosthesis Heat transfer property.
Main function of the micro-nano electronic device 2 in lesion breast prosthesis be by the fever of electronic device accurately, can Part caused by pathological tissues position is apparently higher than normal structure due to metabolism in regulation and control simulation human breast High temperature.There is micro-nano electronic device 2 functional layer, the functional layer to include at least fuel factor functional layer.The thermal effect of micro-nano electronic device 2 Answer functional layer that can simulate localized hyperthermia caused by pathological tissues in human breast, Heating mechanism can be the joule effect of resistance wire It answers, can also be the fuel factor of LED constant power devices.
As shown in Fig. 2, the basic structure of micro-nano electronic device 2 includes micro-nano electron device package layer 5, micro-nano electronic device Functional layer 6 and micro-nano electronic substrate layer 7.Micro-nano electron device package layer 5 plays mechanically and electrically protective effect, micro-nano electronics Device substrate layer 7 plays a supportive role, and the similar material institute made membrane of material of main part 1 both can be used, be not particularly limited.It is described Functional layer includes at least fuel factor functional layer, and metal can be used as resistance wire or unencapsulated LED chip in fuel factor functional layer Deng the electronic material with fuel factor.In addition, in some embodiments of the present invention, the functional layer is in addition to including fuel factor Further include with the functional layers such as light or electricity other than functional layer.
As shown in figure 3, micro-nano electronic device 2 has flexible and ductility.The flexibility of micro-nano electronic device 2 passes through control Each layer thickness is realized in micro-nano electronic device 2.The minimum bending radius of micro-nano electronic device 2 characterizes its flexible degree, this is most Small-bend radius is determined by the ultimate strain value of material in thickness of detector and micro-nano electronic device functional layer 6.Micro-nano electronic device 2 Ductility by serpentine curve 6a as shown in the figure on micro-nano electronic substrate layer 7 from face bending deformation ensure.
The bending stiffness of flexibility requirements device is small, can easily be bent with adapt to material of main part 1 be possible to because Localized hyperthermia and existing curvature.Ductility require device tensible rigidity it is small, can in face Direction distortion it is non-to adapt to 1 surface of material of main part that can be opened up.
Further, micro-nano electronic device 2 can have both multiple functions, including types of functionality element to conduct mechanics, optics etc. Different signals.For example, the strain sensing component of semiconductor/metal piezoresistive effect, piezoelectric material buckling effect may be used Energy harvesting components etc..
The size of micro-nano electronic device 2 is not particularly limited, as long as can match, simulate in human breast pathological tissues i.e. It can.
In conjunction with Fig. 1 and Fig. 3, flexible heating device has lead 6b, wherein the flexible heating device of described lead one end connection, That is micro-nano electronic device 2, optionally, the other end expose from the prosthese bottom part body, are connect with external circuitry.Reveal in lead 6b In the case of going out, the signal of micro-nano electronic device 2 is connected with external circuitry by extraction wire 6b and realizes transmission and processing.
Chemical modification site 3 is the material of main part by chemical modification.Pass through the main body to apery body normal galactophore tissue Material 1 carries out chemical modification processing, it can be achieved that the volume in chemical modification site 3 accurately may be used with modified power, heat, light property Control.Main function of the material of main part in lesion breast prosthesis by chemical modification is simulation human breast lesion springform The change of amount can also simulate change or the light of human breast lesion thermodynamic parameter in some embodiments of the present invention Learn the change of property.
Material of main part by chemical modification has following characteristics:The chemical treatment being modified to it can be by designization It learns reaction principle and the volume and modified power, heat, light property essence of the material of main part 3 Jing Guo chemical modification is realized in dosage control It is really controllable.This modification can be realized by certain physical-chemical reaction.By taking PDMS as an example, ultraviolet light may be used in it According to mode realize Surface hardened layer, can locally instill additional curing dose by way of realize hardening, part can also be passed through Corona treatment realizes that indicative of local optical property changes.
The local physical property variation of simulation lesion site can be used one or more physics fever sites and/or one or Multiple chemical modification sites carry out site-directed quantitative control.Further, the local physical property of imitative lesion breast tissue can be used embedding Enter to decline nanometer electronic device and local chemical modification realization site-directed quantitative control.
When the prosthese of imitation lesion breast is studied for realizing breast cancer calorifics, the embedded micro-nano electronic device has One of two features below:1) ultra-thin super soft extending, and device effective thermal conductivity and tissue are close;2) device volume is micro- It is small.Features described above ensures that the insertion of the micro-nano electronic device in addition to realizing the adjustable of local temperature field, not appreciably affects disease Become breast prosthesis entirety thermal capacitance and heat conduction parameters.When imitating the prosthese of lesion breast for realizing breast cancer mechanics study, institute The firmness change of imitative lesion breast tissue can be reflected well by stating local chemical modification.Embedded micro-nano is controlled by site-directed quantitative Electronic device and local chemical modification, state of development (" lesion " degree) of infallible simulation breast cancer etc..
In addition, if it is necessary, certain topological structure can be doped in material of main part in apery body normal galactophore tissue The one-dimensional heat conduction material 4 of distribution simulates the blood vessel in human breast.One-dimensional heat conduction material 4 includes:Copper wire, silver wire etc. heat it is good Conductor material.Certain topological structure refers to Major Vessels pattern in imitative human breast.
With reference to figure 1, one-dimensional heat conduction material 4 simulates the distribution of human breast medium vessels in lesion breast prosthesis.Human breast In blood vessel can transmit heat by blood flow, there is similar human breast vascular distribution by increasing in material of main part 1 One-dimensional heat conduction material 4 can be simulated by its good heat conductivility the partial heat transmission.One-dimensional heat conduction material 4 have with Lower feature:Thermal coefficient is substantially better than material of main part 1, can be processed into 3 dimension space network structures of certain configuration.One-dimensional heat conduction The material that material 4 can select includes that metals, the nonmetallic materials such as carbon fiber, graphene such as silver, copper are not particularly limited.
Therefore, the one-dimensional heat conduction material with topological structure distribution in prosthese of the invention, to simulate human breast blood Pipe distribution form and arrange, optionally at least the one-dimensional heat conduction material of part can expose from prosthese bottom part body.Pass through setting Such one-dimensional heat conduction material can further make the calorifics, mechanics, optical property of the bionical prosthese in the present invention closer to true The performance of lesion breast.
As a result, as shown in Figure 1, lesion breast prosthesis is the shape with imitative human breast.Lesion breast prosthesis mainly by 4 parts form below:Material of main part 1, micro-nano electronic device 2, the material of main part 3 by chemical modification and one-dimensional heat conduction material Material 4.
The prosthese provided by the invention for imitating lesion breast can provide reliably for the research towards breast cancer monitoring treatment Experiment in vitro carrier, the accurate of lesion locations and lesion intensity further can be achieved and simulate and dynamic control.
<Second embodiment>
Second embodiment of the present invention provides a kind of preparation method for the prosthese imitating lesion breast, the method packet Include following steps:
A) the step of forming the mold with human breast shape;
B) the step of forming the prosthese for imitating lesion breast in the mold,
The prosthese includes prosthese main body and the simulation lesion site in prosthese main body.The prosthese main body by The material of main part of apery body normal galactophore tissue is formed, and it has the shape for imitating human breast;The simulation lesion position Point includes one or more physics fever sites and/or one or more chemical modifications site, and the physics generates heat site by soft Heat pyrexia device is formed, and the flexible heating device has lead, wherein the flexible heating device of described lead one end connection, Optionally, the other end exposes from the prosthese bottom part body.
Step a) is realized based on 3D scannings and printing technique.Imitative human breast pattern is scanned auxiliary with printing technique using 3D Realization is helped, breast pattern threedimensional model file is established using 3D scanning techniques first, is then provided using 3D printing technique printing There is the ghost of breast pattern.
Ghost with breast pattern is preferably hard ghost, becomes imitative Breast model.Printed material can select to commonly use Rigid polymer printed material, such as resin.Commercially available resin can be used, this is not particularly limited.In order to make prosthese master Body can easily be removed from imitative Breast model, can add releasing agent thereto, reduce obstruction when stripping.Alternatively, can also Polishing ghost inner surface, keeps the contact interface between mold and prosthese main body smooth easily separated.It is beaten as a result, using 3D in step a) Impression method forms imitative Breast model.
Further, step b) includes the following steps:
I) liquid-state silicon gel precursor material is partially filled with into inverted imitative Breast model, later by liquid-state silicon gel precursor Material solidification obtains soft silica gel material;
Ii) in the fixed one or more physics fevers site and/or one of above-mentioned soft silica gel material surface forming position A or multiple chemical modifications site,
Repeat above-mentioned steps i) and ii), until the usable part of mold is filled, each soft silica gel material All form prosthese main body.
Step i) progress specific as follows:Specific location and number of the pathological tissues in breast are determined, in imitative Breast model The water of same height is poured at the height of middle pathological tissues design position, and the volume of water at this time is recorded using graduated cylinder;It obtains every Liquid volume corresponding to a pathological tissues position height is corresponding in turn to the apery phosphor bodies material bodies of different height from top to bottom Product, number A, B, C ...
Further, the material of main part 1 for weighing the apery body normal galactophore tissue that volume is A pours into imitative Breast model 9, and And make its solidification.
Liquid-state silicon gel precursor material has following characteristics:Curable high molecular polymer has high resiliency, heat after solidification Mechanics parameter (such as thermal coefficient, thermal capacitance etc.) organizes average thermodynamic parameter similar or elasticity modulus and human body breast with human breast Glandular tissue average elastic modulus is close.Cure liquid silica precursor material and obtain soft silica gel material, is i.e. material of main part 1.Such as Upper described, PDMS can be used in material of main part 1,The silicon rubber high molecular material such as Dragonskin, hydrogel etc..
Step ii) it can carry out as follows:After the solidification of liquid-state silicon gel precursor material, micro-nano electricity is placed in corresponding horizontal plane position Sub- device 2 changes such as imitation leather skin resistive element, or in corresponding horizontal plane position (such as at the surface of material of main part 1 3) application chemistry Property processing obtain chemical modification site 3.
Include the scanning of the detection to the lesion breast of real human body in addition, before step a), detection scanning includes determining The shape of true lesion breast and the specific location and volume of lesion.The tool of identified lesion is scanned according to detection as a result, The position for the simulation lesion site that body position and volume are arranged in the prosthese for imitating lesion breast and volume.
Above-mentioned detection scanning can be carried out by 3D scanning techniques.Imageological examination is can be combined with, including mammary X-ray is taken the photograph Shadow (breast molybdenum target photograph), color ultrasound, can also carry out mammary gland magnetic resonance inspection (MRI) when necessary.According to having built up and relatively complete Kind means determine the specific location and volume of lesion.Further, it is possible to be designed according to known Modeling Theory to be prepared Imitation lesion breast prosthese specific pattern.
The preparation method of the prosthese of the imitation lesion breast of the present invention can further be wrapped between step a) and step b) Including setting in a mold has the step of one-dimensional heat conduction material of topological structure distribution, to simulate the shape of human breast vascular distribution State and arrange, optionally so that at least part of one-dimensional heat conduction material expose from the prosthese bottom part body.
As described above, one-dimensional heat conduction material has following characteristics:Thermal coefficient is substantially better than apery body normal galactophore tissue Material of main part 1, and 3 dimension space network structures of certain configuration can be processed into.Have by increasing in material of main part The one-dimensional heat conduction material of similar human breast vascular distribution can simulate partial heat transmission by its good heat conductivility. So can more accurately simulated lesion breast, also can more accurately detect the signal of pathological tissues.
From the 6 of Fig. 4) in as it can be seen that it is finally obtained imitate lesion breast prosthese include prosthese main body 1 and included in vacation Simulation lesion site 2,3 in phosphor bodies.Prosthese main body 1 is formed by the material of main part 1 of apery body normal galactophore tissue, and its With the shape for imitating human breast.It includes one or more micro-nano electronic devices 2 and/or one or more to simulate lesion site Chemical modification site 3.There is micro-nano electronic device 2 lead, one end of lead to connect micro-nano electronic device, optionally, the other end Expose from the bottom of prosthese main body 1.
In addition, in step ii) in, formation haircut thermal potential point flexible heating device in a manner of negative pressure physics fit in Soft silica gel material surface and/or chemical modification site pass through the shape to the progress chemical modification processing of soft silica gel material surface At.The mode of the negative pressure, such as can refer to being formed the surface that flexible heating device is contacted with soft silica gel using equipment Vacuum state so that the two is connected with Van der Waals force.And when such connection type subsequently to reinject material of main part Undesirable displacement will not occur for flexible heating device.
In step ii) in, flexible heating device is maintained in the state of negative pressure on soft silica gel material surface, thus Can be closely integrated with material of main part 1 by Van der Waals force, avoid the precursor material of follow-up bulk material pour into and it is solid Change and changes its position.Thus, it can be achieved that pathological tissues spatial positions is precisely controlled in lesion breast prosthesis.
Chemical modification processing can be realized by certain physical-chemical reaction.It can be according to the reality of breast lesion tissue Situation designs chemical modification reaction principle and controls modification degree.For example, the mode that ultraviolet lighting may be used realizes surface Hardening can realize hardening by way of locally instilling additional curing dose, can also be handled and be realized by local plasma Indicative of local optical property changes.
The soft Silica Surface handled by chemical modification accurately controls its volume and power, heat, light property, simulates human body The change of elasticity modulus or the change of thermodynamic parameter or the change of optical property at breast lesion.
The preparation method of the prosthese of imitation lesion breast through the invention, can be long according to the specific disease of patient Phase monitors the state of development or treatment breast cancer of breast cancer, realizes personalized medicine.
As shown in figure 4, the preparation flow of lesion breast prosthesis can be divided into following steps:
1) human breast is scanned using 3D scanning techniques, establishes breast pattern threedimensional model;As shown in Fig. 4 (1), The hard ghost with breast pattern is printed from printer nozzle 8 using 3D printing technique, obtains imitative Breast model 9.It beats Print material can select common rigid polymer printed material, such as resin.When 3D printing, breast threedimensional model need to be adjusted and be had There is certain thickness ghost, such as 1mm thickness.9 surface of Breast model can be imitated to printing gained to polish, make with sand paper if necessary Its is smooth.If have ready-made breast threedimensional model, 3D scanning modelings process can remove from.
2) if it is necessary, the step of increasing doped one-dimensional Heat Conduction Material 4 after the 1) step.
3) specific location and number of the pathological tissues in breast are determined according to experiment in vitro demand.As shown in Fig. 4 (2), Breast model nipple is placed downward, and fixed, is poured into equally at the height of pathological tissues design position in imitative Breast model The water of height, and utilization graduated cylinder records the volume of water at this time;Liquid volume corresponding to each pathological tissues position height is obtained, from Under to the apery phosphor bodies material volume for being above corresponding in turn to different height, number A, B, C ...
4) material of main part 1 for the apery body normal galactophore tissue that volume is A is weighed, and is poured into imitative Breast model.
5) after the solidification of the material of main part 1 of A volumes, micro-nano electronics is placed in the corresponding position of pathological tissues on the horizontal plane Device 2.Vacuumize the air excluded between the two interface so that micro-nano electronic device 2 can rely on Van der Waals force and main body material Material 1 is closely integrated, and avoid follow-up bulk material 1 pours into and cure the position for changing micro-nano electronic device 2.Realize lesion Pathological tissues spatial position is precisely controlled in breast prosthesis.
6) or after the solidification of material of main part 1, the corresponding position of pathological tissues applies chemical modification and handles in the horizontal plane To the material of main part 3 Jing Guo chemical modification, as shown in Fig. 4 (3).
7) step 4,5 and/or 6 are repeated, are filled up by material of main part 1 until imitating Breast model 9, such as Fig. 4 (4) or Fig. 4 (5) institute Show.
8) the lesion breast prosthesis that solidification is completed is demoulded from imitative Breast model 9, obtains final lesion breast prosthesis, As shown in Fig. 4 (6).It completes to prepare.
<Third embodiment>
Third embodiment of the present invention provides a kind of method to human breast lesion detection device optimization or check and correction, It includes the following steps:
The step of preparing to imitate the prosthese of lesion breast, prosthese is above-mentioned prosthese or passes through the vacation of above method acquisition Body;
The step of obtaining the true detection data of prosthese;
Prosthese is tested to obtain test data using to be optimized or check and correction human breast lesion detection device Step;
True detection data and test data are compared, and then the step of optimizing or proofreading human body breast lesion detection device.
As shown in figure 5, when the prosthese of the present invention for imitating lesion breast is used for breast cancer experiment in vitro, it can be by lesion breast For room prosthese as in heating plate 10, temperature of heating plate is adjusted to 37 DEG C of simulation human body basal body temperatures;Test device 11 is integrated in lesion Breast prosthesis surface.Test device 11 provides imitative lesion group by parameters such as calorifics, mechanics, the optics of measurement lesion breast prosthesis The spatial position knitted and " lesion " degree." lesion " organizational parameter (including position and intensity) is surveyed by contrast test device 11 It, can be to test device 11 and based on the breast cancer detection for testing device 11 with true " lesion " organizational parameter in lesion breast prosthesis Technology is tested and is optimized.It is preferably the novel medical device according to new theoretical model design to test device 11.
True detection data and/or test data include thermal data, Mechanical Data, optical data or combinations thereof.It utilizes The prosthese of above-mentioned imitation lesion breast of the invention measures true detection data and test data respectively as experiment in vitro carrier And it is compared, thus quick response human breast lesion detection device can be adjusted.
In the new theoretical model of design and optimization Novel electronic devices and verification, method through the invention can facilitate Novel electronic devices are easily transformed and improve new detection mechanism.
<Embodiment>
Specific embodiment is as follows.
Embodiment a:Lesion breast prosthesis a
The present embodiment using 3D printing technique and flexible electronic Technology design and will prepare the mammary gland based on calorifics principle Cancer detects the lesion breast prosthesis of experiment in vitro, can be used for the test of the breast cancer detection device performance based on calorifics principle with it is excellent Change and the verification of breast cancer detection mechanism based on calorifics principle.The lesion breast prosthesis can quantify positioning simulation human body When lesion tissue metabolism acutely, heat build-up and the conducting heat model of localized hyperthermia that generates.
First, test patient a is chosen as subjects, and the breast for testing patient a is swept using 3D scanning techniques It retouches, establishes breast pattern threedimensional model.The three-dimensional breast model ghost of resin material, breast and chest are printed using 3D printing technique Portion's intersection is open for ghost model.Phantom thicknesses are 1mm.With dry sanding paper polishing ghost inner surface, keep its smooth.
The opening up placement of breast model ghost that will be printed.According to test experiments scheme, each " lesion " tissue is determined Spatial position.Water is poured into ghost successively, liquid level is made to be flushed with spatial position where " lesion " tissue, by weighing water at this time Volume obtain the material of main part volume that the position height should be poured into, and bulking value is numbered from low to high according to spatial position For A, B, C ....Dry breast model ghost.
Material of main part selects PDMS.The PDMS that volume is A is poured into breast model ghost, standing waits for that PDMS cures.According to According to the above-mentioned 3 d scan data of patient a, the corresponding position in the surfaces PDMS after hardening is placed using flexible electronic technology system The standby extending resistance device of flexibility.The bubble for excluding the two interface is vacuumized, makes device can be with PDMS by Van der Waals force Surface is realized and is closely integrated, and avoids follow-up liquid PDMS's from pouring into and cure change device position.It repeats the above steps, Zhi Daomo Quasi- " lesion " tissue for completing all patient a, and PDMS fills up breast model ghost.
After PDMS is fully cured, by itself and mould separating, the breast cancer detection experiment in vitro based on calorifics principle is obtained Lesion breast prosthesis a.Since the resistance value R of device is certain, the calorific value Q of local location can use joule formula Q=in prosthese I2R carries out quantitative calculating.Simultaneously by control device by electric current I size, the calorific value of local location can be realized The control of dynamic quantitative.
Prosthese a is tested using measurement device, by test value and actual value to compare the measurement device into Row calibration or optimization.
Therefore, use the lesion breast prosthesis not only can be to the nature static of measurement device as breast cancer experiment in vitro carrier Matter measures and optimizes, and can also have measurement and optimization function for the dynamic response characteristic of measurement device.
Embodiment b:Lesion breast prosthesis b
Other than selecting to test patient b as subjects, obtained in a manner of identical with embodiment a former based on calorifics The lesion breast prosthesis b of the breast cancer detection experiment in vitro of reason.
Using measurement device, in a manner of identical with embodiment a, lesion breast prosthesis b is detected.In conjunction with lesion breast The truthful data of room prosthese b measures and optimizes to the static nature and dynamic response characteristic of measurement device.
Embodiment c:Lesion breast prosthesis c
The present embodiment using 3D printing technique and flexible electronic Technology design and will prepare the mammary gland based on calorifics principle Cancer detects the lesion breast prosthesis of experiment in vitro.
According to ready-made breast pattern threedimensional model, resin material is printed using 3D printing technique, obtains hard ghost Imitative Breast model.Breast is mould openings, thickness 1mm with chest intersection.With sand paper to gained imitate Breast model surface into Row polishing, keeps its smooth.
One-dimensional heat conduction material is arranged in imitative Breast model, imitates the vascular distribution in breast, and make it can be from prosthese Expose the bottom of main body.
Based on spatial position, volume size and the lesion degree of each preset " lesion " tissue, test experiments scheme is designed c.By the opening up placement of the ghost of the imitative Breast model printed.Choose main bodys of the PDMS as apery body normal galactophore tissue Material.The PDMS of certain volume is poured into imitative Breast model, standing waits for its solidification.Rule are designed on the surfaces PDMS after hardening The extending resistance device of flexibility prepared using flexible electronic technology is placed in the position drawn, and vacuumizes both exclusions interface Bubble, so that device and the surfaces PDMS is realized and be closely integrated.It repeats the above steps, until completing all " lesions " being pre-designed The integrated and PDMS of device fills up imitative Breast model ghost at tissue.
The lesion breast prosthesis that solidification is completed is demoulded from imitative Breast model, finally obtains the mammary gland based on calorifics principle Cancer detects the lesion breast prosthesis c of experiment in vitro, completes to prepare.
Prosthese c is tested using measurement device, by test value and actual value to compare the measurement device into Row calibration or optimization.
Embodiment d:Lesion breast prosthesis d
(flexibility for changing test experiments scheme c in embodiment c can other than designing other test experiments scheme d The position of spreading resistance device), it is external that the breast cancer detection based on calorifics principle is obtained in a manner of identical with embodiment c The lesion breast prosthesis d of experiment.
Prosthese c is tested using measurement device, by test value and actual value to compare the measurement device into Row calibration or optimization.
Further above example is prepared for 4 group models, therefore, can be based on any of which one or more models The comparison of the test data of truthful data and measurement device, from static state to dynamic optimization measurement device.Therefore, by designing disease Become breast prosthesis, and as breast cancer experiment in vitro carrier, human breast lesion detection device can be adjusted Or optimization.
It will be appreciated by those skilled in the art that attached drawing is the schematic diagram of a preferred embodiment, the embodiments of the present invention Serial number is for illustration only, can not represent the quality of embodiment.
The foregoing is merely presently preferred embodiments of the present invention, is not intended to limit the invention, it is all the present invention spirit and Within principle, any modification, equivalent replacement, improvement and so on should all be included in the protection scope of the present invention.
Industrial availability
The prosthese of the imitation lesion breast provided through the invention can provide for the research towards breast cancer monitoring treatment Accurate simulation and dynamic control of the lesion locations with lesion intensity further can be achieved in reliable experiment in vitro carrier.In addition, logical The preparation method for crossing the prosthese of the imitation lesion breast of the present invention, can be according to the specific disease of patient, long term monitoring mammary gland The state of development or treatment breast cancer of cancer.In addition, through the invention to human breast lesion detection device optimization or check and correction Method, can optimize or proofread novel medical device, thus can design and optimization Novel electronic devices and the novel theory of verification Model.

Claims (13)

1. a kind of prosthese imitating lesion breast, which is characterized in that the prosthese includes prosthese main body, and is included in prosthese master Internal simulation lesion site, wherein
The prosthese main body is formed by the material of main part of apery body normal galactophore tissue, and it has the outer of imitation human breast Shape;
The simulation lesion site includes one or more physics fever sites and/or one or more chemical modifications site,
Physics fever site is formed by flexible heating device, and the flexible heating device has lead, wherein described The flexible heating device of lead one end connection, the optionally other end expose from the prosthese bottom part body.
2. prosthese according to claim 1, which is characterized in that the material of main part of apery body normal galactophore tissue includes Soft silica gel material.
3. prosthese according to claim 1 or 2, which is characterized in that the flexibility heating device includes micro-nano electronic device, There is the micro-nano electronic device functional layer, the functional layer to include at least fuel factor functional layer.
4. according to claim 1-3 any one of them prostheses, which is characterized in that the prosthese has the one of topological structure distribution Heat Conduction Material is tieed up, is arranged in the form of simulating human breast vascular distribution, optionally at least the one-dimensional heat conduction of part Material exposes from the prosthese bottom part body.
5. a kind of preparation method for the prosthese imitating lesion breast, which is characterized in that described method includes following steps:
A) the step of forming the mold with human breast shape;
B) the step of forming the prosthese for imitating lesion breast in the mold,
The prosthese includes prosthese main body, and the simulation lesion site in prosthese main body, wherein
The prosthese main body is formed by the material of main part of apery body normal galactophore tissue, and it has the outer of imitation human breast Shape;
The simulation lesion site includes one or more physics fever sites and/or one or more chemical modifications site,
Physics fever site is formed by flexible heating device, and the flexible heating device has lead, wherein described The flexible heating device of lead one end connection, the optionally other end expose from the prosthese bottom part body.
6. according to the method described in claim 5, it is characterized in that, forming the mould using 3D printing method in the step a) Tool.
7. method according to claim 5 or 6, which is characterized in that the step b) includes the following steps:
I) liquid-state silicon gel precursor material is partially filled with into the inverted mold, later by the liquid-state silicon gel precursor material Material solidification obtains soft silica gel material;
Ii) in the fixed one or more physics fever sites of above-mentioned soft silica gel material surface forming position and/or one or Multiple chemical modification sites,
Repeat above-mentioned steps i) and ii), until the usable part of mold is filled, each soft silica gel material it is complete Body forms the prosthese main body.
8. the method according to the description of claim 7 is characterized in that in step ii) in, form the soft of physics fever site It is logical that heat pyrexia device physics in a manner of negative pressure fits in the soft silica gel material surface and/or the chemical modification site It crosses and chemical modification processing is carried out to the soft silica gel material surface and is formed.
9. according to claim 5-8 any one of them methods, which is characterized in that before step a), including to real human body Lesion breast detection scanning, the detection scanning include the determination true lesion breast shape and lesion it is specific Position and volume.
10. according to the method described in claim 9, it is characterized in that, according to the specific of lesion determined by the detection scanning The position for the simulation lesion site that position and volume are arranged in the prosthese and volume.
11. according to claim 5-10 any one of them methods, which is characterized in that between step a) and step b), also wrap Including setting in the mold has the step of one-dimensional heat conduction material of topological structure distribution, to simulate human breast vascular distribution Form and arrange, the one-dimensional heat conduction material of optionally at least part exposes from the prosthese bottom part body.
12. a kind of method to human breast lesion detection device optimization or check and correction, which is characterized in that include the following steps:
The step of preparing to imitate the prosthese of lesion breast, the prosthese be according to claim 1-4 any one of them prosthese or The prosthese that person obtains according to any one of claim 5-11 the methods;
The step of obtaining the true detection data of the prosthese;
The prosthese is tested to obtain test data using to be optimized or check and correction human breast lesion detection device Step;
True detection data and the test data are compared, and then optimizes or proofread the step of the human breast lesion detection device Suddenly.
13. according to the method for claim 12, which is characterized in that the true detection data and/or test data include Thermal data, Mechanical Data, optical data or combinations thereof.
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