CN108853596B - Shape memory polymer breast stent and preparation method thereof - Google Patents

Shape memory polymer breast stent and preparation method thereof Download PDF

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CN108853596B
CN108853596B CN201810823079.6A CN201810823079A CN108853596B CN 108853596 B CN108853596 B CN 108853596B CN 201810823079 A CN201810823079 A CN 201810823079A CN 108853596 B CN108853596 B CN 108853596B
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shape memory
memory polymer
breast support
breast
shape
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CN108853596A (en
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冷劲松
张风华
李春妍
刘彦菊
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Harbin Institute of Technology
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Harbin Institute of Technology
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses and implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00—Materials specially adapted for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses
    • A61F2240/004—Using a positive or negative model, e.g. moulds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/16—Materials with shape-memory or superelastic properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/04—Materials or treatment for tissue regeneration for mammary reconstruction

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  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
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  • Manufacturing & Machinery (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention provides a shape memory polymer breast support and a preparation method thereof, and particularly relates to a shape memory polymer breast support which is of a three-dimensional structure and comprises a supporting part and a bionic part, wherein the bionic part is positioned in the supporting part, the contour of the supporting part is the same as that of a breast, the bionic part comprises a plurality of branches arranged around a central point, and the central point is close to the vertex of the supporting part. The shape memory polymer breast stent is made of shape memory polymer, has good shape memory performance and biocompatibility, can be biodegraded, and does not generate rejection reaction after being implanted into a human body; can be prepared into a temporary shape which is small in size and easy to implant in a minimally invasive way, provides possibility for implanting the breast support in a minimally invasive operation, reduces medical cost, reduces pain of a patient and improves life quality of the patient.

Description

Shape memory polymer breast stent and preparation method thereof
Technical Field
The invention relates to the technical field of medical material manufacturing, in particular to a shape memory polymer breast stent and a preparation method thereof.
Background
The breast support, also called breast prosthesis, breast prosthesis or artificial breast, is the most ideal substitute for breast replacement for breast missing people due to cancer and the like, but the common breast support with limited types and shapes cannot meet the different practical application requirements of patients on tumor size, operation incision, breast size, height and the like because the size, shape and body form of female breasts are different.
Patients suffering from breast cancer generally need to perform breast and mastectomy, and the wearing discomfort, even skin damage or infection can be caused by the friction between the implanted common breast stent and the operative hole, scars and the like of the patients.
In view of the above-mentioned drawbacks, the inventors of the present invention have finally obtained the present invention through a long period of research and practice.
Disclosure of Invention
In view of the above, the present invention is directed to a shape memory polymer breast support, so as to solve the problem that the size and shape of the breast support do not meet the practical application requirements, and skin damage or infection is easily caused.
In order to achieve the purpose, the technical scheme of the invention is realized as follows:
a shape memory polymer breast support is of a three-dimensional structure and comprises a supporting part and a bionic part, wherein the bionic part is positioned in the supporting part, the contour of the supporting part is the same as that of a breast, the bionic part comprises a plurality of branches arranged around a central point, and the central point is close to the vertex of the supporting part.
Further, the branch is formed by gradually converging a plurality of small branches.
Further, the shape memory polymer breast support is designed by computer software according to medical image data.
Further, the shape memory polymer breast support is made of biodegradable and biocompatible shape memory polymer, and the biodegradable and biocompatible shape memory polymer is selected from one or more of polylactic acid, polyvinyl alcohol, polyurethane, polycaprolactone, chitosan, epoxidized acrylate, crosslinked polyethylene, polynorbornene, trans-polyisoprene or styrene-butadiene copolymer.
Further, the material of the shape memory polymer breast stent also comprises a medicament.
Further, the material of the shape memory polymer breast support also comprisesFunctional particles having magnetism, preferably, the functional particles having magnetism are Fe3O4。
Further, the shape memory polymer breast support is deformed into a temporary shape at a material transition temperature and returns to an original shape under a driving condition, preferably, the driving condition includes magnetic driving, temperature driving, pH driving, specific ion driving, and enzyme driving.
Further, the magnetic drive has the external magnetic field conditions that the coil diameter is 0-18 cm and the power is 10-100 Hz; preferably, the external magnetic field is one or more of an external magnetic field with the coil diameter of 3cm and the power of 10-30 KHz, an external magnetic field with the coil diameter of 6cm and the power of 20-40 KHz, an external magnetic field with the coil diameter of 9cm and the power of 10-30 KHz, an external magnetic field with the coil diameter of 12cm and the power of 20-40 KHz, an external magnetic field with the coil diameter of 15cm and the power of 10-30 KHz and an external magnetic field with the coil diameter of 18cm and the power of 20-40 KHz.
Compared with the prior art, the shape memory polymer breast support has the following advantages:
(1) the shape memory polymer breast stent is made of shape memory polymer, has good shape memory performance and biocompatibility, can be biodegraded, can not generate rejection reaction after being implanted into a human body, breast tissue cells can be attached to the stent to grow, proliferate and differentiate, the breast stent is gradually biodegraded, the breast stent is continuously filled by the inward growth of the cells, finally the breast stent can be completely degraded within three to five years, the breast stent is completely replaced by self tissues, and the appearance of the breast after operation of a patient due to illness is almost the same as that before the operation.
(2) The shape memory polymer breast support can be prepared into a temporary shape which is small in size and easy to implant in a minimally invasive mode, the breast support deforms by itself under a driving condition, the temporary shape is changed into an initial shape, the preset three-dimensional space shape is finally achieved, skin and tissue growth is supported, the breast support is implanted in a minimally invasive operation possibly, medical cost is reduced, pain of a patient is reduced, and life quality of the patient is improved.
(3) The shape memory polymer breast stent can carry medicine, releases the medicine in the sick breast of a patient, and achieves the purposes of inhibiting the growth and the diffusion of cancer cells, preventing or treating wound infection, resisting inflammation, easing pain, improving immunity and the like.
(4) The shape memory polymer breast support can meet the individual requirements of patients, different individual drug-loaded breast support models are designed according to the data of tumors, breasts, mammary glands and the like of different patients, the requirements of the patients on the breast support can be fully considered, and the possibility is provided for realizing the individual customization.
(5) The shape memory polymer breast support comprises magnetic functional particles, can realize remote control without directly contacting a patient, and is recovered to an initial shape from a set temporary shape under the excitation condition of an external magnetic field; by controlling the diameter and frequency of the external magnetic field, the recovery speed and degree of the breast support are accurately controlled, the deformation degree and speed of the breast support are controlled according to the acceptance degree of the body of a patient, time and space are provided for the proliferation of skin cells and fat cells of the patient, and the breast reconstruction possibility is provided for patients who have no space for reconstructing breasts after a total incision operation due to the breast cancer.
The invention also aims to provide a preparation method of the shape memory polymer breast support, so as to overcome the defect that the existing breast support is limited in size and shape and cannot meet the requirements of different patients.
In order to achieve the purpose, the technical scheme of the invention is realized as follows:
a preparation method of a shape memory polymer breast stent comprises the following steps: designing an initial shape of the breast support, preparing a breast support material, and printing the breast support material into the designed initial shape of the breast support by a 4D printing technology.
Further, the 4D printing technique is selected from a fused deposition modeling manufacturing technique, a direct write modeling manufacturing technique, a stereolithography rapid prototyping manufacturing technique, or a polymer jetting technique.
Compared with the prior art, the preparation method of the shape memory polymer breast stent has the following advantages:
(1) the preparation method of the invention utilizes the 4D printing technology to prepare the shape memory polymer breast support, the 4D printing technology is not limited by a complex structure, is suitable for the personalized customization of the breast support, and has wider application prospect; the 4D printing technology has the characteristic of rapid forming, greatly shortens the preparation time of the breast support mold, has low preparation cost, simple preparation method and strong practicability, is easily accepted by consumers, and has remarkable social and economic benefits.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate an embodiment of the invention and, together with the description, serve to explain the invention and not to limit the invention. In the drawings:
FIG. 1A is a schematic view of a supporting portion of a shape memory polymer breast support according to an embodiment of the present invention;
FIG. 1B is a schematic diagram of a bionic portion of a shape memory polymer breast support according to an embodiment of the present invention
FIG. 1C is a schematic diagram of a shape memory polymer breast support according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a fusiform temporary shape structure of a SMP breast stent according to an embodiment of the present invention;
FIG. 3 is a schematic structural diagram of a shape memory polymer breast support according to an embodiment of the present invention, which recovers its original shape after applying a magnetic field to its temporary fusiform shape;
FIG. 4 is a schematic diagram of a temporary shape structure of a small disk of a shape memory polymer breast support according to an embodiment of the present invention;
fig. 5 is a schematic structural diagram of a breast support with a shape memory polymer breast support with a temporary small disk shape and a magnetic field applied thereto for restoring the original shape according to an embodiment of the present invention.
Detailed Description
It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.
The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.
Example one
The present embodiment provides a shape memory polymer breast support. Specifically, the shape memory polymer breast support is a three-dimensional structure and comprises a supporting part and a bionic part, wherein the bionic part is positioned in the supporting part (as shown in fig. 1C), the contour of the supporting part is the same as the contour of the outer part of the breast, the bionic part comprises a plurality of branches arranged around a central point, and the central point is close to the vertex of the supporting part. Preferably, the plurality of branches are arranged in a radial pattern. Further, the branch is formed by gradually converging a plurality of small branches. One possible structure of the supporting portion is shown in fig. 1A, and one possible structure of the biomimetic portion is shown in fig. 1B.
After the shape memory polymer breast stent is implanted into a human body, mammary tissue cells can be attached to and grow, proliferate and differentiate in the bionic part of the stent, the cells continuously fill gaps in the middle of the bionic part of the breast stent, after a period of time, human body tissues form a main body of a breast, meanwhile, due to the fact that the supporting part effectively avoids breast deformation caused by ectopic growth of the tissues, the volume balance of the breast after operation is maintained, the appearance of the breast is almost the same as that before the operation, and the shape is maintained to be attractive.
Preferably, the material of the shape memory polymer breast support comprises a biodegradable and biocompatible shape memory polymer. On one hand, the biodegradable and biocompatible shape memory polymer can not generate rejection reaction after being implanted into a human body, and the pain of a patient is effectively relieved; on the other hand, the breast support can be gradually biodegraded, the breast support can be completely replaced by self tissues, the breast support cannot be left in a patient body for a long time, and the breast support is safer for the patient.
Further, the biodegradable and biocompatible shape memory polymer is selected from one or more of polylactic acid, polyvinyl alcohol, polyurethane, polycaprolactone, chitosan, epoxidized acrylate, crosslinked polyethylene, polynorbornene, trans-polyisoprene or styrene-butadiene copolymer.
Preferably, the material of the shape memory polymer breast support further comprises a drug. In some embodiments, the mass ratio of the shape memory polymer to the drug is 20000: 1. The medicine is one or more of antitumor medicine, anti-infective medicine, antiviral medicine, antifungal medicine, antiinflammatory and analgesic medicine, and immunopotentiator. After being implanted, the common breast stent can cause discomfort of wearing and even skin damage or infection when being rubbed with the operation mouth, scars and the like of a patient, and the breast stent added with medicaments such as anti-cancer medicaments, anti-infection medicaments, anti-inflammatory analgesic medicaments, immunopotentiators and the like releases medicaments in the sick breasts of the patient, thereby achieving the curative effects of inhibiting the growth and diffusion of cancer cells, preventing or treating wound infection, resisting inflammation and easing pain, improving immunity and the like.
The erosion and degradation of the breast stent carrying the drug by the body fluid of the human body enables the drug to be slowly released and dissolved.
Further, the anti-infective drug is one or more of oxaliplatin, isohedrine, paclitaxel, docetaxel, gemcitabine, capecitabine, rituximab, hydroxycamptothecin, pirarubicin or epirubicin.
Furthermore, the anti-infective drug is one or more of beta lactam antibiotics, aminoglycoside antibiotics, macrolide antibiotics or quinolones.
Further, the antiviral drug is one or more of ribavirin, acyclovir or ganciclovir.
Further, the anti-inflammatory analgesic drug is one or more of aspirin, acetaminophen, indomethacin, naproxen, naproxone, diclofenac, ibuprofen, nimesulide, rofecoxib or celecoxib.
Further, the antifungal drug is clotrimazole or ketoconazole and the like.
Further, the immunopotentiator is one or more of chemically synthesized drugs (such as levamisole and isoprinosine), human or animal immune products (such as thymosin, transfer factor, interferon and interleukin), microorganism-derived drugs (such as BCG), fungal polysaccharides (such as lentinan) or traditional Chinese medicine effective components.
Preferably, the material of the shape memory polymer breast support further comprises functional particles with magnetic properties. Further, the functional particles with magnetism are Fe3O4. The functional particles with magnetism are nontoxic to human body.
The shape memory polymer breast support is deformed into a temporary shape at the material transition temperature, is reduced to room temperature after being compressed, is implanted into a human body or placed in an environment simulating the body fluid of the human body, and is recovered to the original shape under the driving condition. The temporary shape can be prepared into a shape which is small in size and easy to implant in a minimally invasive mode, is deformed after being implanted into a human body, is changed into an initial shape from the temporary shape, and finally reaches a preset three-dimensional space shape, so that the breast support can be implanted in a minimally invasive operation.
The temporary shapes include a shuttle shape as shown in fig. 2 and a small disc shape as shown in fig. 4. Returning to the original shape under driving conditions, the shuttle shape corresponds to the restored shape as shown in FIG. 3, and the small circle shape corresponds to the restored shape as shown in FIG. 5.
The driving conditions include magnetic driving, temperature driving, pH driving, specific ion driving, and enzyme driving. Further, the temperature driving condition is that the affected part is hot compressed at a temperature not less than the deformation temperature so as to recover to the original shape, for example, when the shape memory polymer is polylactic acid, the hot compression temperature is not less than 45 ℃; when the transition temperature of the shape memory polymer breast support is body temperature, hot compress is not needed. Further, the driving conditions of the shape memory polymer breast support include human pH, specific enzymes in body fluids and specific ions in body fluids, and the shape memory polymer breast support in the temporary shape can be restored to the original shape when exposed to these driving conditions.
Preferably, when the shape memory polymer breast support material comprises functional particles with magnetism, the diameter of the magnetically-driven external magnetic field coil is 0 cm-18 cm, and the power is 10-100 KHz.
Furthermore, the external magnetic field is one or more of an external magnetic field with the diameter of 3cm and the power of 10-30 KHz, an external magnetic field with the diameter of 6cm and the power of 20-40 KHz, an external magnetic field with the diameter of 9cm and the power of 10-30 KHz, an external magnetic field with the diameter of 12cm and the power of 20-40 KHz, an external magnetic field with the diameter of 15cm and the power of 10-30 KHz and an external magnetic field with the diameter of 18cm and the power of 20-40 KHz.
For example, the healing of the wound of a patient is influenced to a certain extent by overhigh temperature, change of pH, uneven enzyme distribution and uneven ion distribution, and the magnetic driving mode has obvious advantages compared with the driving modes such as temperature driving, pH driving, enzyme driving, specific ion driving and the like. The magnetic drive is a remote control drive mode, the breast support can be restored under the condition of not contacting with the wound part of a patient, the wound is protected to the maximum extent, the secondary wound is reduced to the maximum extent by the remote control magnetic drive, and the operation risk is greatly reduced.
In addition, during the magnetic driving, the deformation degree and speed of the breast support are controllable, such as: the frequency of the magnetic field is reduced, and the shape recovery speed of the breast support becomes slow; the shape of the breast support stops recovering immediately when the external magnetic field is turned off, and the like. Therefore, according to the acceptance degree of the body of the patient, the recovery speed and the recovery degree of the breast support can be accurately controlled by controlling the diameter size and the frequency change of the external magnetic field, and time and space are provided for the proliferation of skin cells and fat cells of the patient. For example, in some patients who have undergone a total resection for breast cancer, the breasts of the patients are not spatially reconstructed, and the magnetically driven shape memory polymer breast support can precisely control the recovery speed and degree of the breast support by controlling the diameter and frequency of the magnetic field, thereby providing time and space for the growth of skin cells and fat cells.
The magnetic drive of the shape memory polymer breast stent provides a breast remodeling method for patients with long tumor resection time, meets the external shape requirements of the patients, improves the life quality of the patients, and solves the problems of physiology, psychology, family and the like, which cannot be replaced by other methods.
This embodiment also provides a method for preparing the above shape memory polymer breast stent, comprising: designing an initial shape of the breast support, preparing a breast support material, and printing the breast support material into the designed initial shape of the breast support by a 4D printing technology.
The 4D printing technology is not limited by a complex structure, is suitable for the personalized customization of the breast support, and has wider application prospect; the 4D printing technology has the characteristic of rapid forming, greatly shortens the preparation time of the breast support mold, has low preparation cost, simple preparation method and strong practicability, is easily accepted by consumers, and has remarkable social and economic benefits.
Further, the breast support material is prepared by mixing the shape memory polymer, the drug and the functional particles with magnetism at room temperature according to the proportion, wherein, in some embodiments, the adding amount of the drug and/or the functional particles with magnetism is zero.
Further, the 4D printing technique is selected from a fused deposition modeling manufacturing technique, a direct write modeling manufacturing technique, a stereolithography rapid prototyping manufacturing technique, or a polymer jetting technique.
Further, the preparation method comprises the steps of heating the breast support with the initial shape to a transition temperature, reducing the temperature to room temperature after compression, and obtaining the breast support with a temporary shape with a small volume;
further, the temporary shaped breast support is placed in a simulated body fluid environment or implanted into a human body and then returns to its original shape under driving conditions.
Example two
This example provides another shape memory polymer breast support, which differs from the first example in that: personalized customization of shape memory polymer breast scaffolds, specifically, the initial shape of a breast scaffold is designed by computer software from medical image data.
The present embodiment also provides a method for preparing a shape memory polymer breast support, which is different from the first embodiment in that: the initial shape of the breast support, including but not limited to three-dimensional models and dimensions, is designed by computer software from the medical image data.
Before operation, a human body three-dimensional scanner, a Magnetic Resonance Imaging (MRI) technology, a CT scanning technology and the like are applied to acquire medical image data of tumors, mammary glands and breasts of a patient, the obtained data are processed through medical simulation software, computer aided design and other software, and the initial shape of the breast support is designed and established, including but not limited to the shape and the size of the supporting part, the number of branches of the bionic part, the shape and the like, so that the personalized requirements of the patient are met, the requirements of the patient on the breast support can be fully considered, and personalized customization is realized.
EXAMPLE III
The embodiment provides a preparation method of a shape memory polymer breast stent, which comprises the following steps: designing an initial shape of the breast support, preparing a breast support material, and printing the breast support material into the designed initial shape of the breast support by a 4D printing technique, preferably, the breast support material comprises a shape memory polymer. The initial shape of the breast support includes, but is not limited to, a three-dimensional model and dimensions.
Preferably, the shape memory polymer is a biodegradable and biocompatible shape memory polymer. Firstly, the biodegradable and biocompatible shape memory polymer can not generate rejection reaction after being implanted into a human body, thereby effectively relieving the pain of a patient; secondly, the breast support can be gradually biodegraded, the breast support can be completely replaced by self tissues, the breast support cannot be left in the body of a patient for a long time, and the breast support is safer for the patient.
Further, the biodegradable and biocompatible shape memory polymer is selected from one or more of polylactic acid, polyvinyl alcohol, polyurethane, polycaprolactone, chitosan, epoxidized acrylate, crosslinked polyethylene, polynorbornene, trans-polyisoprene or styrene-butadiene copolymer.
Preferably, the breast support material further comprises a drug. In some embodiments, the mass ratio of the shape memory polymer to the drug is 20000: 1. The medicine is one or more of antitumor medicine, anti-infective medicine, antiviral medicine, antifungal medicine, antiinflammatory and analgesic medicine, and immunopotentiator. After being implanted, the common breast stent can cause discomfort of wearing and even skin damage or infection when being rubbed with the operation mouth, scars and the like of a patient, and the breast stent added with anti-cancer drugs, anti-infection drugs, anti-inflammatory analgesic drugs, immunopotentiators and other drugs releases the drugs in the sick breasts of the patient, thereby achieving the curative effects of inhibiting the growth and diffusion of cancer cells, preventing or treating wound infection, anti-inflammatory analgesic drugs, improving immunity and the like.
The erosion and degradation of the breast stent carrying the drug by the body fluid of the human body enables the drug to be slowly released and dissolved.
Further, the anti-infective drug is one or more of oxaliplatin, isohedrine, paclitaxel, docetaxel, gemcitabine, capecitabine, rituximab, hydroxycamptothecin, pirarubicin or epirubicin.
Furthermore, the anti-infective drug is one or more of beta lactam antibiotics, aminoglycoside antibiotics, macrolide antibiotics or quinolones.
Further, the antiviral drug is one or more of ribavirin, acyclovir or ganciclovir.
Further, the anti-inflammatory analgesic drug is one or more of aspirin, acetaminophen, indomethacin, naproxen, naproxone, diclofenac, ibuprofen, nimesulide, rofecoxib or celecoxib.
Further, the antifungal drug is clotrimazole, ketoconazole, etc.
Further, the immunopotentiator is one or more of chemically synthesized drugs (such as levamisole and isoprinosine), human or animal immune products (such as thymosin, transfer factor, interferon and interleukin), microorganism-derived drugs (such as BCG), fungal polysaccharides (such as lentinan) or traditional Chinese medicine effective components.
Preferably, the breast support material further comprises functional particles with magnetic properties. Further, the functional particles with magnetism are Fe3O4. The functional particles with magnetism are nontoxic to human body.
Preferably, the breast support material is obtained by mixing the shape memory polymer, the drug and the magnetic functional particles at room temperature in proportion, wherein, in some embodiments, the addition amount of the drug and/or the magnetic functional particles is zero.
Further, the 4D printing technique is selected from a fused deposition modeling manufacturing technique, a direct write modeling manufacturing technique, a stereolithography rapid prototyping manufacturing technique, or a polymer jetting technique. The 4D printing technology is not limited by a complex structure, is suitable for the personalized customization of the breast support, and has wider application prospect; the 4D printing technology has the characteristic of rapid forming, greatly shortens the preparation time of the breast support mold, has low preparation cost, simple preparation method and strong practicability, is easily accepted by consumers, and has remarkable social and economic benefits.
Further, the preparation method also comprises the following steps: and heating the breast support with the initial shape to the transition temperature, reducing the compression temperature to room temperature to obtain the breast support with the temporary shape with smaller volume.
Further, the temporary shaped breast support is placed in a simulated body fluid environment or implanted into a human body and then returns to its original shape under driving conditions.
The temporary shape can be prepared into a shape which is small in size and easy to implant in a minimally invasive mode, is deformed after being implanted into a human body, is changed into an initial shape from the temporary shape, and finally reaches a preset three-dimensional space shape, so that the breast support can be implanted in a minimally invasive operation.
The driving conditions include magnetic driving, temperature driving, pH driving, specific ion driving, and enzyme driving. Further, the temperature driving condition is that the affected part is hot compressed at a temperature not less than the deformation temperature so as to recover to the original shape, for example, when the shape memory polymer is polylactic acid, the hot compression temperature is not less than 45 ℃; when the transition temperature of the shape memory polymer breast support is body temperature, hot compress is not needed. Further, the driving conditions of the shape memory polymer breast support include human pH, specific enzymes in body fluids and specific ions in body fluids, and the shape memory polymer breast support in the temporary shape can be restored to the original shape when exposed to these driving conditions.
Preferably, when the shape memory polymer breast support material comprises magnetic functional particles, the magnetic driving external magnetic field condition is that the coil diameter is 0 cm-18 cm, and the power is 10-100 KHz.
Furthermore, the external magnetic field is one or more of an external magnetic field with the diameter of 3cm and the power of 10-30 KHz, an external magnetic field with the diameter of 6cm and the power of 20-40 KHz, an external magnetic field with the diameter of 9cm and the power of 10-30 KHz, an external magnetic field with the diameter of 12cm and the power of 20-40 KHz, an external magnetic field with the diameter of 15cm and the power of 10-30 KHz and an external magnetic field with the diameter of 18cm and the power of 20-40 KHz.
For example, the healing of the wound of a patient is influenced to a certain extent by overhigh temperature, change of pH, uneven enzyme distribution and uneven ion distribution, and the magnetic driving mode has obvious advantages compared with the driving modes such as temperature driving, pH driving, enzyme driving, specific ion driving and the like. The magnetic drive is a remote control drive mode, the breast support can be restored under the condition of not contacting with the wound part of a patient, the wound is protected to the maximum extent, the secondary wound is reduced to the maximum extent by the remote control magnetic drive, and the operation risk is greatly reduced.
In addition, during the magnetic driving, the deformation degree and speed of the breast support are controllable, such as: the frequency of the magnetic field is reduced, and the shape recovery speed of the breast support becomes slow; the shape of the breast support stops recovering immediately when the external magnetic field is turned off, and the like. Therefore, according to the acceptance degree of the body of the patient, the recovery speed and the recovery degree of the breast support can be accurately controlled by controlling the diameter size and the frequency change of the external magnetic field, and time and space are provided for the proliferation of skin cells and fat cells of the patient. For example, in some patients who have undergone a total resection for breast cancer, the breasts of the patients are not spatially reconstructed, and the magnetically driven shape memory polymer breast support can precisely control the recovery speed and degree of the breast support by controlling the diameter and frequency of the magnetic field, thereby providing time and space for the growth of skin cells and fat cells.
The magnetic drive of the shape memory polymer breast stent provides a breast remodeling method for patients with long tumor resection time, meets the external shape requirements of the patients, improves the life quality of the patients, and solves the problems of physiology, psychology, family and the like, which cannot be replaced by other methods.
Example four
This example provides a method for preparing a shape memory polymer breast stent, which is different from the third example in that: personalized customization of shape memory polymer breast scaffolds, the initial shape of a particular breast scaffold is designed by computer software from medical image data.
Before operation, a human body three-dimensional scanner, a Magnetic Resonance Imaging (MRI) technology, a CT scanning technology and the like are applied to acquire medical image data of tumors, mammary glands and breasts of a patient, the obtained data are processed through medical simulation software, computer aided design and other software, the initial shape of the breast support is designed and established, including but not limited to a three-dimensional model and size, the personalized requirements of the patient are met, the requirements of the patient on the breast support can be fully considered, and personalized customization is realized.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (8)

1. The shape memory polymer breast support is characterized in that the shape memory polymer breast support is of a three-dimensional structure and comprises a supporting part and a bionic part, the bionic part is located in the supporting part, the outline of the supporting part is the same as the outline of a breast in shape, the bionic part comprises a plurality of branches arranged around a central point, the branches are formed by gradually converging a plurality of small branches, and the central point is close to the top point of the supporting part.
2. The shape memory polymer breast support of claim 1, wherein said shape memory polymer breast support is designed by computer software from medical image data.
3. The shape memory polymer breast stent of claim 1, wherein the material of the shape memory polymer breast stent comprises a biodegradable and biocompatible shape memory polymer selected from one or more of polylactic acid, polyvinyl alcohol, polyurethane, polycaprolactone, chitosan, epoxidized acrylate, crosslinked polyethylene, polynorbornene, trans-polyisoprene or styrene-butadiene copolymer.
4. The shape memory polymer breast support of claim 1, wherein the material of the shape memory polymer breast support further comprises a drug.
5. The shape memory polymer breast support of claim 1, wherein the material of the shape memory polymer breast support further comprises a functional particle with magnetic properties, the functional particle with magnetic properties being Fe3O4。
6. The shape memory polymer breast support of claim 1, wherein said shape memory polymer breast support deforms to a temporary shape at a material transition temperature and returns to an original shape under driving conditions, said driving conditions comprising magnetic driving, temperature driving, pH driving, specific ion driving, and enzyme driving.
7. A shape memory polymer breast support according to claim 6, wherein the magnetically driven external magnetic field conditions are coil diameter of 0-18 cm and power of 10-100 KHz.
8. A method of making a shape memory polymer breast support according to any one of claims 1 to 7, comprising the steps of: designing an initial shape of a breast support, preparing a breast support material, and printing the breast support material into the designed initial shape of the breast support through a 4D printing technology; the 4D printing technology is selected from fused deposition modeling manufacturing technology, direct-write modeling manufacturing technology, three-dimensional light curing rapid prototyping manufacturing technology or polymer jetting technology.
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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CN105997301A (en) * 2016-04-25 2016-10-12 哈尔滨工业大学 Intelligent deformable method for artificial prosthesis based on shape memory polymer

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013112350A1 (en) * 2012-01-24 2013-08-01 Lifecell Corporation Elongated tissue matrices
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