JP2016214829A - Method for calculating filling volume of self-tissue for breast reconstruction, manufacturing method for breast reconstruction template, breast reconstruction template, and medical brassier - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method for highly accurately and simply calculating the filling volume of a self-tissue for breast reconstruction, a method for precisely and simply manufacturing a template for highly accurately and precisely reproducing breast reconstruction technique, the template, and a medical brassiere constituted by utilizing the template.SOLUTION: The method includes transforming three-dimensional scan data of a breast acquired by a scanner into three-dimensional polygonal data, three-dimensional CAD data, and three-dimensional solid data, calculating the filling volume of the self-tissue on the basis of the three-dimensional solid data, and three-dimensionally designing a base part of a reconstructed breast on the basis of shape data in which a skin thickness is off-set.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a template utilization technique for performing breast reconstruction with high accuracy, and more particularly to a method for calculating an appropriate amount of autologous tissue to be inserted into a reconstruction breast lumen, and a medical bra using the template. Is.

  Breast reconstruction is a plastic surgery that reconstructs a breast whose shape has been severely damaged due to trauma or breast cancer resection. A pair of breasts is the most important symbol of beauty for women, and the symbol of the mother who nurtures the growth of infants. It has a great impact on the of life (QOL). Although it is possible to cheat to some extent with underwear, etc., it is troublesome, accompanied by bathing in the public bath and lagging on sea bathing, and sometimes severe depression. For this reason, breast reconstruction is a serious problem for women.

  Breast reconstruction methods include: (A) Reconstruction using own body tissue (autologous tissue), (B) Reconstruction using silicon artificial breast (implant), and (A) There is a method of combining both (B) (combination of autologous tissue and implant).

  As a method of (A), a method of transplanting the autologous tissue of the patient's back, abdomen, or buttocks to the lumen side of the preserved breast epidermis is common. According to this method, scars remain on the back, abdomen, or buttocks where the tissue is taken, and the operation time and hospitalization period will be longer, but because the body tissue is used, natural softness and warmth should be ensured. Can do. In addition, the possibility of regenerating and transplanting autologous tissue using iPS cell technology is also depicted as a feasible dream. However, it goes without saying that a certain period of time is required until the transplanted adipose tissue is integrated with the healthy tissue.

  In the method (B), a tissue expander (tissue expander) that expands the epidermis of the breast from the lumen side is used in combination, and then the shape and size are adapted from the ready-made implants that are artificial products. Then, since reconstruction is performed by selecting what is considered to be inserted into the lumen, the operation time and hospitalization period can be shortened. However, it is rare that it can reproduce the appearance that can be said to be the same as the breast shape and size before surgery, or even if the shape and size are satisfactory, a so-called solid molded product is inserted. Therefore, the natural softness and elasticity of the human body, or the unnaturalness of lacking warmth that reflects body temperature cannot be hidden.

  The method of combining (A) and (B) is to restore the original shape and size with an implant alone, or to restore the preoperative breast volume only with the autologous tissue. In cases where the amount of self tissue inserted is too small (including the case where the amount of insertion is insufficient due to the intention of preventing unnatural imbalance in the left and right imbalances), It is. Specifically, a method of inserting a silicone resin into the back side of the breast lumen and disposing autologous adipose tissue on the epidermis side is common.

  In either method, the shape of the lost breast is estimated and reconstruction is performed so as to restore the shape. At this time, it is assumed that the human breast has a substantially symmetrical shape on the left and right, and usually the breast that has not been removed, that is, the healthy side (hereinafter referred to as the healthy side) The shape of the missing breast is estimated based on the inverted shape, or with some further correction. It is also being studied to prepare pre-operative breast shapes as data and prepare for reconstruction.

  Regarding breast reconstruction, for example, Patent Literature 1 discloses a tissue transplantation method for soft tissue reconstruction or augmentation. Specifically, collecting a certain amount of adipose tissue from a patient, processing the collected amount of adipose tissue by centrifugation, isolating a purified subset of adipose tissue, and reconstructing soft tissue as purified adipose tissue Alternatively, a method comprising implanting a patient in a region identified for augmentation based on a three-dimensional (3D) infusion route model.

  Patent Document 2 discloses a body reconstruction model shape data creation apparatus, method, and program that can easily and inexpensively create a reconstruction model for reconstructing a missing body part. Specifically, (1) the measurement data of the three-dimensional shape of the body part is adjusted, (2) a mesh is generated based on the obtained data, and (3) the vertex of this mesh is changed to the body part to be reconstructed. Assigned to the surface, (4) Extract vertex data located at the periphery of the reconstruction target part, (5) Estimate the reference bottom surface from these vertex data, (6) Start the vertex on the reference bottom surface, the healthy body part (7) Generate three-dimensional shape data of the surface shape of the reconstructed model from the inverted vector data and the vertex data of the deficient side reference bottom surface, and (8) From the three-dimensional shape data of the surface shape and the three-dimensional shape data of the surface shape of the defective body part, the three-dimensional shape data of the entire shape of the reconstruction model is generated.

  Patent Document 3 discloses a breast regeneration adjustment method for preparation for improving the appearance balance of the breast after breast reconstruction. Specifically, when adjusting a breast substitute for preparation for breast reconstruction, (1) a breast female mold production step of creating a breast female mold by transferring a remaining breast or a breast to be removed from the breast; (2) A housing step for housing the breast substitute in the recessed portion of the female breast mold (accommodating the recessed portion so as to include a portion protruding from the recessed portion), and (3) the protruding portion Size adjustment process or display process for displaying a reference line that removes or reduces the protruding part of the breast substitute as an unnecessary part of the breast substitute, or displays the boundary where the protruding part is not folded back And (4) an alternative preparation step of taking out and preparing as a breast substitute from the breast female mold after the size adjustment step or the display step.

  According to Patent Document 4, the self-tissue collected from the patient can be adjusted and restored to the shape and size of the breast before excision regardless of the skill of the operator, the patient's restraint time is short, and the burden on the patient is reduced. As an invention to be made, a method for producing a breast reconstruction forming cup and a breast reconstruction foaming cup prepared by the method are disclosed. Specifically, (1) a step of acquiring a three-dimensional shape of the chest before excision of a standing or sitting patient, (2) a step of designing a chest model from the three-dimensional shape data, and (3) A breast having a step of producing a chest model based on design data; (4) a step of covering and adhering a plastic film softened by heating to the model; and (5) a step of removing the plastic film from the model after cooling. A method for producing a reconstruction foaming cup and a breast reconstruction foaming cup prepared by the method are disclosed.

JP 2014-158933 A JP 2013-165862 A JP2013-000330A Japanese Patent Laying-Open No. 2015-054089

  The tissue transplantation method described in Patent Document 1 provides a tissue transplantation method for soft tissue reconstruction or augmentation. The rotational speed and the rotation time when adipose tissue collected from a patient is processed by a centrifuge. It is necessary to become familiar with the adjustment of water and oil / oil separation technique, and the transplanting method itself is complicated and expensive, and there are many problems for practical use.

  In the invention of Patent Document 2, it is said that a reconstruction model for reconstructing a body part partially missing can be easily and inexpensively produced, but after adjusting the measurement data of the three-dimensional shape of the body part The process leading to the generation of the entire shape data of the reconstruction model is complicated, and there are many problems in practical use.

  In the invention of Patent Document 3, when adjusting a breast substitute for preparation for breast reconstruction, a breast female mold is created by previously transferring a remaining breast or a breast to be removed from the breast. Acquisition is limited in the quantity and quality of data, and problems remain from the viewpoint of data accuracy.

  The invention of Patent Document 4 is based on the three-dimensional shape data of the chest and can model the outer shape and appearance of the chest, but the base of the breast (a concept newly defined in the present invention, which will be described later). Since it does not include the concept of modeling, there remains a problem in terms of reproducing an accurate shape.

  The present invention has been made in consideration of the above-mentioned problems related to breast reconstruction and requests from the medical field, and is a method for calculating the autologous tissue filling capacity in breast reconstruction with high accuracy and simplicity, A method for accurately and simply producing a template for accurately and accurately reproducing a reconstructed breast, and a template produced by these methods, particularly a self-tissue of the filling capacity (total amount) calculated above, The present invention provides a template that can be accurately and simply injected by dividing a required amount into necessary portions, and further a medical bra configured by using the template.

  The method of the present invention that has solved the above-mentioned problems is a method for calculating the autologous tissue filling capacity in breast reconstruction, the step of converting the three-dimensional breast scan data acquired by the scanner into three-dimensional polygon data, and Including a step of converting 3D polygon data into 3D CAD data and a step of converting 3D CAD data into 3D solid data, and calculating a self-tissue filling capacity based on the 3D solid data, It is characterized in that it includes a step of three-dimensionally designing the base of the reconstructed breast based on the shape data offset by the minutes. The term “breast base” as used in the present specification is the basic part or the basic part in order to properly arrange and maintain the appearance and size of the reconstructed breast, and is the first stage in the breast reconstruction step. It is formed by typical treatment.

  As the three-dimensional solid data, the entire breast curved surface including the areola edge and the lower curved surface and the upper curved surface of the breast can be created.

  Next, a method for manufacturing a breast reconstruction template includes converting 3D scan data of a breast acquired by a scanner into 3D polygon data, converting the 3D polygon data into 3D CAD data, and converting the 3D CAD data into the 3D CAD data. A data processing process that converts data to 3D solid data, and a 3D model for modeling the external shape and appearance for breast reconstruction by NC milling high density foam material based on 3D solid data A first three-dimensional model production step, a first template production step of pressing a resin sheet preheated and softened against the first three-dimensional model and producing a first template by vacuum forming, and further filling In order to calculate the capacity of the self-organized tissue, after processing the offset data of the 3D solid data, NC A second three-dimensional model production process for producing a three-dimensional model for modeling a portion that becomes a base of a breast after reconstruction by processing a rice board, and a resin sheet that has been softened by heating in advance. And a second template production step of producing a second template by vacuum forming.

  In the present invention, the reconstructed breast can be reproduced with an external shape corresponding to the original shape of the healthy breast by the first template. The second template is used as a container for correcting the shape of the autologous tissue to be transplanted during reconstruction and measuring the proper autologous tissue capacity, or for selecting and determining the optimal implant having the appropriate shape and size. It becomes a technical element.

  In the first template preparation step and the second template preparation step, it is preferable to perform sterilization after each step and before use for breast reconstruction. In addition, when using these templates by the technique which does not contact a biological body directly, a sterilization process can also be skipped.

  It is preferable that the first three-dimensional model and the second three-dimensional model are for performing vacuum molding on the resin sheet, and as the material, one that can be precision-cut is optimal, and the workability and mechanical strength are improved. In consideration, for example, a high-density foam material can be used. As other materials, aluminum alloy, chemical wood, or the like can be used.

  The resin sheet preferably has an appropriate load deflection temperature (thermal deformation temperature). If one of the specific indices is shown, for example, a 1.80 MPa load deflection temperature in accordance with JIS K 7191-2 is 50. A thermoplastic resin having a temperature of ˜150 ° C. is preferable, and a resin capable of coping with sterilization treatment such as polyethylene terephthalate, polybutylene terephthalate, polycarbonate, polypropylene, polyacetal, and polyamide can be used. However, the resin material does not limit the present invention.

  The breast reconstruction template can be obtained by the above manufacturing method, but it is needless to say that the first template and the second template preferably do not change in shape before and after the sterilization treatment.

  Assuming that the breast reconstruction template is used for breast reconstruction by fat injection, the first template for breast reconstruction is used for injecting centrifugally treated adipose tissue into a plurality of locations on the margin of the areola of the template. Are preferably perforated, and more preferably at a plurality of locations in the lower breast groove and / or the upper breast groove.

  In addition, it is preferable that the holes are formed at 4 to 8 positions at substantially equal intervals in the circumferential direction at the edge of the areola of the template, and further in the circumferential direction in the lower breast groove and / or the upper breast groove. More preferably, 4 to 8 places are opened at substantially equal intervals.

  Furthermore, the present invention can provide a medical bra based on the first template obtained above.

  According to the method for calculating the autologous tissue filling capacity in breast reconstruction of the present invention, the 3D scan data of the breast acquired by the scanner is converted into 3D polygon data, and the 3D polygon data is converted into 3D CAD data. It is possible to convert the 3D CAD data into 3D solid data and calculate the autologous tissue filling capacity based on this data. Therefore, autologous tissue filling has been difficult in breast reconstruction until now. The capacity can be calculated accurately. In addition, regarding the breast reconstruction, when the above-described method (A) or the combination method of the method (A) and the method (B) is performed, an optimal implant suitable for the patient is selected from various existing implants. It becomes possible to select.

  Next, according to the method for manufacturing a breast reconstruction template of the present invention, the 3D scan data of the breast acquired by the scanner is converted into 3D polygon data, and the 3D polygon data is converted into 3D CAD data. The 3D CAD data is converted into 3D solid data, and a high density foam material is NC milled on the basis of the 3D solid data, thereby modeling the external shape and appearance for breast reconstruction. A one-dimensional model can be prepared, and a first template can be manufactured by pressing a resin sheet preheated and softened against the first three-dimensional model and vacuum forming. Nevertheless, it is possible to obtain the first breast reconstruction template in which the appearance of the breast is accurately reproduced with respect to the shape and size.

  In addition, in order to calculate the capacity of the self-tissue to be filled, based on the above-mentioned three-dimensional solid data, by using the three-dimensional solid data obtained by processing the offset data, the part that becomes the base of the breast after reconstruction From the above, it is possible to produce a second three-dimensional model for modeling the above, further press the softened and softened resin sheet against the second three-dimensional model, and produce a second template by vacuum molding. Although it is a low-cost and simple method, a very accurate second template for breast reconstruction can be obtained.

  Furthermore, according to the method for manufacturing a breast reconstruction template of the present invention, a large number of three-dimensional scan data acquired in advance from each patient can be used and utilized, so that it corresponds to breasts of various shapes and sizes. This makes it possible to produce a highly accurate breast reconstruction template. This is expected to contribute to the creation of materials that support custom-made breast reconstruction.

  By using the breast reconstruction template of the present invention, it is possible to return a breast that has been deformed or lost due to breast cancer treatment or the like to a good restoration state including not only appearance but also texture and volume. As a result, the conventional breast reconstruction often requires post-operative repair processing by multiple operations and procedures, whereas using the breast reconstruction template of the present invention, Breast reconstruction can be performed with high accuracy by treatment (no need for complementary surgery after correction), and the time required for one surgery can be shortened. Here, the term “once” includes all the steps for performing a treatment for further finishing the appearance of the breast after the above-mentioned base is formed, and this finishing step is a single surgical operation. Whether it is performed continuously or once the operation is finished and performed after an appropriate number of times is left to the discretion of the operator based on the patient's wishes and conditions.

  Since the medical bra of the present invention can be manufactured to have substantially the same size and the same shape as the appearance of the reconstructed breast, the filled autologous tissue fat is used as epidermal tissue in the reconstructed breast. It is extremely effective in maintaining the breast shape at the time when the reconstruction is completed over the period until the fusion and integration.

  The method for calculating the self-tissue filling capacity of the present invention, the method for manufacturing a breast reconstruction template, and the template manufactured by these methods, particularly, the self-tissue of the calculated filling capacity (total amount) as a necessary site Templates that can be injected accurately and simply by dividing the required amount, and medical bras, can be created by creating new industries and new technologies by combining medical regeneration technology and manufacturing technology, which have had few technical contacts. It is possible to create a business model and to contribute to Japan's economic development.

It is a flowchart which shows the process of the manufacturing method of the template for breast reconstruction which concerns on embodiment of this invention. It is a drawing substitute photograph which shows an example of the 1st three-dimensional model produced in the manufacture process of this invention. It is a conceptual diagram which shows an example of the vacuum forming method used at the 1st template preparation process of this invention. It is a drawing substitute photograph which shows an example of the template for breast reconstruction which concerns on embodiment of this invention. It is a drawing substitute photograph which shows an example of the 1st template for breast reconstruction in which the hole for inject | pouring the adipose tissue by which the centrifugation process of this invention was made.

  Hereinafter, a method for calculating self-filling capacity for breast reconstruction, a method for manufacturing a breast reconstruction template, a breast reconstruction template, and a medical bra according to an embodiment of the present invention will be described with reference to the drawings. The embodiment of the present invention will be described by taking as an example a method (combination of autologous tissue and implant) performed by combining (A) and (B) in the breast reconstruction method.

  A method for manufacturing a breast reconstruction template according to an embodiment of the present invention includes (1) converting 3D scan data of a breast acquired by a scanner into 3D polygon data, and then converting the 3D polygon data into 3D Breast reconstruction by converting to CAD data and further processing the data by converting the 3D CAD data to 3D solid data, and (2) NC milling the high density foam material based on the 3D solid data. A first three-dimensional model production process for producing a three-dimensional model for modeling the external shape / appearance for use, and (3) pressing a preheated and softened resin sheet against the first three-dimensional model, and vacuum forming Including a first template manufacturing step of manufacturing the first template, and (4) calculating a capacity of the self-organized tissue to be filled A second solid model producing step for producing a three-dimensional model for modeling a portion to be a base of a breast after reconstruction by processing an NC milling machine of a high-density foam material after offset data processing of the data; and (5 And a second template manufacturing step of pressing a softened and softened resin sheet against the second three-dimensional model and manufacturing a second template by vacuum forming.

  FIG. 1 is a flowchart showing the steps (1) to (5) described above. With reference to this flowchart, a method for manufacturing a breast reconstruction template, a breast reconstruction template, and a method for calculating an autologous tissue filling capacity will be described.

(1) Data processing step A three-dimensional (3D) scanner (for example, manufactured by Eva Artec) uses three-dimensional scan data of the healthy breast (hereinafter referred to as data X) and three-dimensional scan data of the breast after mastectomy (hereinafter referred to as data X) , Data Y). 3D scan data of data X and data Y is converted from 3D scan (point cloud) data to 3D polygon (triangular patch) data using reverse engineering software (eg, Geologic Design X, 3D Systems). Is further converted into three-dimensional CAD (iges) data. Specifically, unnecessary information is removed from the data, defective elements are reduced, hole filling, contour correction, element number change, component point (triangular patch) optimization, shape smoothing, and the like are performed. By performing this process, it is possible to improve the efficiency of CAD operability. Note that the data X and the data Y are both acquired in the standing position of the patient (the sole is placed on the ground) or in the sitting position.

  The data X converted into the three-dimensional CAD (images) data is inverted on the CAD operation using a three-dimensional CAD (for example, manufactured by Space-E / Modeler / CAM / SolidCAM NTT Data Engineering System). The inverted data X is joined to data Y for matching. Then, the undulating portion at the time of matching is trimmed by CAD operation, and the data X is converted into three-dimensional solid data by using the trimmed data Y curved surface. The data X converted into the three-dimensional solid data becomes data having mass and volume information (hereinafter referred to as solid data X). Then, from the information on the mass and volume of the solid data X, the capacity L1 of the external shape of the breast after reconstruction can be obtained.

(2) First Stereo Model Production Step FIG. 2 is a drawing substitute photograph showing an example of the first stereo model produced in the manufacturing process of the present invention. The CAM (Computer Aided Manufacturing: For example, Space-E / Modeler / CAM / SolidCAM NTT Data Engineering System Co., Ltd.) system is used to create the 3D model of the solid data X obtained in the above process. The processing data for processing the first three-dimensional model is produced. An NC (Numerical Control) milling machine (machine tool) is moved according to the processing data, and the first three-dimensional model is produced with high accuracy. The first three-dimensional model is used when producing the first template in the next step.

  The first three-dimensional model produced in the above process becomes a model for vacuum forming used for forming the first template in the next process. At that time, in order to efficiently perform vacuum forming, a step of drilling along the parting line of the first three-dimensional model is required. The first three-dimensional model with holes for vacuum forming (hereinafter, referred to as the first three-dimensional model with vacuum holes) produced in the above process is manufactured using a material of a high-density foam material. Specifically, in consideration of workability and mechanical strength, it is preferable to use a foamed polystyrene having a foaming ratio of 5 to 30 times, more preferably 10 to 20 times, particularly preferably about 15 times. preferable. The processing of the first three-dimensional model with a vacuum hole can be performed using a commercially available drilling machine.

(3) First Template Manufacturing Step FIG. 3 is a conceptual diagram showing an example of a vacuum forming method used in the first template manufacturing step. FIG. 4 is a drawing-substituting photograph showing an example of a breast reconstruction template obtained by using the vacuum forming method of FIG. (A) shows a 1st template and (b) shows the 2nd template mentioned later.

  The resin sheet 2 previously heated and softened by the heater 3 can be pressed against the first three-dimensional model 1 with vacuum holes obtained in the first three-dimensional model manufacturing step, and then manufactured by vacuum molding. Around the first three-dimensional model 1 with vacuum holes, several holes that penetrate to the bottom are provided, and several holes are also provided on the work table 4. In vacuum molding, the gap between the first three-dimensional model 1 with a vacuum hole and the resin sheet 2 is evacuated (reduced pressure) by a vacuum pump, and the resin sheet 2 is in close contact with the first three-dimensional model 1 with a vacuum hole. Let them mold.

  Specifically, the first three-dimensional model 1 with a vacuum hole is installed at a desired position on the work table 4 shown in FIG. A resin sheet 2 (for example, a polyethylene terephthalate sheet or the like) is sandwiched between two upper and lower frames and heated by a heater 3 installed at the upper part of the work table 4 to gradually soften the resin sheet 2 (FIG. 3 ( a)). At an appropriate time, the resin sheet 2 is lowered so as to cover the first three-dimensional model 1 with vacuum holes, and the softened resin sheet 2 is pressed against the first three-dimensional model 1 with vacuum holes (see FIG. 3B). The vacuum pump is activated, and finally the resin sheet 2 sticks to the first three-dimensional model 1 with a vacuum hole in a state along the first template shape (see FIG. 3C). A desired first template is obtained by cooling the resin sheet 2 and removing it from the first three-dimensional model 1 with vacuum holes.

  Note that the hole diameter of the first three-dimensional model 1 with vacuum holes for vacuum suction is, for example, a diameter of 3.0 to 6.0 mm and a hole pitch width of 20 mm in consideration of suction of the resin sheet 2 in a balanced manner. It is preferable to carry out at about 40 mm.

  From the viewpoint of moldability, impact strength, transparency, and durability against autoclave sterilization (for example, 121 ° C., 20 minutes), for example, a polyethylene terephthalate sheet having a thickness of 1.0 mm is used as the resin sheet 2. Most preferred. However, the thickness of the sheet does not limit the present invention.

(4) Second stereo model production process Based on the solid data X obtained in the data processing process, the second stereo model is designed as a three-dimensional solid. Specifically, by performing a three-dimensional CAD operation on the offset of the flap atrophy and the breast outer wall thickness (skin thickness left after surgery) after the fat content of the autologous tissue is transplanted into the body. Do. The capacity L2 is obtained from the second solid model converted to solid data (hereinafter referred to as the second solid model). In order to create the second 3D model from the 3D shape data of the completed 2D solid model, data for processing the 2D model is created using the CAM system. By moving the NC milling machine according to the processing data, the second three-dimensional model can be produced with high accuracy.

  The flap atrophy rate and breast outer wall thickness are set on a case-by-case basis based on each patient's biological data because there are individual differences depending on the patient's age, physique, body fat rate, cancer progression, or surgical procedure. Is done. The volume L2 is the volume of the autologous tissue to be transplanted during the breast reconstruction operation. The information (mass and volume) of the completed 2D solid model is a reference value for the amount of saline to be placed in the tissue expander used during breast reconstruction surgery. This is data for finalizing the specifications.

  Regarding the adjustment of the offset, for example, after defining a line that is offset 5 mm inward from the breast outline above the center of the breast and a line that is offset 8 mm inward from the breast outline below the center of the breast, the offset between the two is determined. While finely adjusting the line with respect to the direction of the broken line of the line, finally, an intersection where both lines overlap is obtained. By this intersection, both offset lines can be connected to determine a desired offset line. The interval between the breast outline and the line to be offset inward is not particularly limited, and can be appropriately adjusted according to the shape and size of the patient's breast and the status of breast reconstruction surgery. It is.

  The second three-dimensional model created in the above process is a model for vacuum forming used for forming the second template in the next process. A material that is perforated along the parting line of the second three-dimensional model (hereinafter, referred to as a second three-dimensional model with a vacuum hole) is used for producing the second template. The production of the second three-dimensional model with vacuum holes is the same as that of the first three-dimensional model with vacuum holes, and it is preferable to use a high-density foam material. Detailed description will be omitted because it is redundant.

(5) Second template manufacturing step The second template can be manufactured in the same manner as the first template. That is, a resin sheet that has been softened by heating in advance is pressed against the second three-dimensional model with vacuum holes, and can be manufactured by vacuum molding. Detailed explanation is omitted for the same reason.

  The first template and the second template are used by performing sterilization at the medical site, but it is desirable that the template shape does not change at all before and after the sterilization.

  In the method for calculating the autologous tissue filling capacity for breast reconstruction of the present invention, after calculating the autologous tissue filling capacity based on the three-dimensional solid data, the base part of the reconstructed breast is calculated based on the shape data offset from the skin thickness. It is characterized by dimension design.

  As a first embodiment of the method of the present invention, there is a method that makes it possible to produce a first template after producing a first three-dimensional model. Further, it is a method that makes it possible to create a second 3D model and then create a second template based on the data after the conversion subjected to offset data processing. By this method, the external volume L1 after breast reconstruction and the autologous tissue volume L2 to be transplanted after breast reconstruction can be calculated.

  As another embodiment, the capacity L1 and the capacity L2 are calculated only by data editing by three-dimensional data operation without creating the first stereo model, the first template, the second stereo model, and the second template. Is also possible.

  Regarding the timing of breast reconstruction, if there is little possibility of metastasis or recurrence, etc., reconstruction is performed at the same time as the removal of the tumor, and observation of the progress from 6 months to 2 years, radiotherapy and anticancer drugs There is a two-phase reconstruction that is reconstructed after confirming that treatment has been completed and no recurrence or metastasis has been observed. In the case of a one-time reconstruction, the information (mass, capacity) of the second solid model becomes three-dimensional information necessary for breast reconstruction, and an implant for the first-stage reconstruction can be appropriately selected. In the case of two-stage reconstruction, in addition to the information held by the second solid model, the high-accuracy breast reconstruction is as close as possible to the healthy breast based on the external volume L1 after breast reconstruction necessary for the second-stage reconstruction. Enable.

  Of the breast reconstruction templates according to the embodiment of the present invention, the first template is useful as a material for supporting breast augmentation by fat injection. Specifically, holes for injecting pre-centrifugated adipose tissue are provided in a plurality of locations on the margin of the areola of the first template for breast reconstruction, and an injection needle is inserted into the hole for injection. While pulling the needle little by little, the plunger is turned to inject the fatty tissue into a thin line. The holes may be provided at a plurality of locations in the lower breast groove and / or the upper breast groove in addition to the edge of the areola.

  FIG. 5 is a drawing-substituting photograph showing an example of a first template for breast reconstruction in which a hole for injecting a centrifuged adipose tissue is formed. The reason why the holes are provided at a plurality of locations on the margin of the areola, the lower breast groove and / or the upper breast groove is to prevent the trace at the time of fat injection from being recognized. Second, in order to improve the dispersibility of adipose tissue in consideration of fat injection in a wide range, since there is a possibility that the breast conforming to the specifications of the template prepared with great care cannot be reconstructed when injection is performed at one place. It is. In order to perform fat injection more reliably and stably, the holes are opened at 4 to 8 locations at almost equal intervals in the circumferential direction in the areola margin of the template, the lower breast groove and / or the upper breast groove. More preferably.

  In an actual operation site, with the first template for breast reconstruction applied to the breast in advance, a place where the adipose tissue should be injected is specified, and a hole is punched at a position suitable for the injection of the adipose tissue. It is also possible (FIG. 5 shows four holes formed at substantially equal intervals in the entire circumference of the areola edge and the upper breast groove). In this case, it is preferable that the size of the hole is about 5 to 6 mm in diameter from the viewpoint that the traces during the injection of the adipose tissue are not known.

  The template for breast reconstruction according to the embodiment of the present invention is expected to play an important role as a material for supporting breast reconstruction, and its use is limited to medical sites that perform breast reconstruction surgery. Absent. Specifically, the reconstructed breast that has undergone breast reconstruction surgery using the autologous tissue can also be used as a material for a medical bra to support the reconstructed breast until the autologous tissue has settled on the patient's body. Is possible. Since the skin side of the brassiere is substantially the same size as the appearance of the reconstructed breast and has the same shape, the filled autologous tissue fat is fused and integrated with the epidermal tissue etc. in the reconstructed breast. Over a period of time, it is extremely effective in maintaining the breast shape at the time of reconstruction.

  As described above, the method for calculating the autologous tissue filling capacity for breast reconstruction, the method for manufacturing a breast reconstruction template, the breast reconstruction template, and the medical bra according to the present invention are medical regeneration that has so far had few technical contacts. By combining technology and manufacturing technology, new industries and new business models can be created, which can be expected to contribute to Japan's economic development.

1 First 3D model with vacuum hole 2 Resin sheet 3 Heater 4 Worktable

Claims (12)

A method for calculating autologous tissue filling capacity in breast reconstruction,
Converting the breast 3D scan data obtained by the scanner into 3D polygon data;
Converting the three-dimensional polygon data into three-dimensional CAD data;
Converting the 3D CAD data into 3D solid data;
The method further comprises the step of calculating the autologous tissue filling capacity based on the three-dimensional solid data and three-dimensionally designing the base of the reconstructed breast based on the shape data offset from the skin thickness.   The method according to claim 1, wherein the three-dimensional solid data creates a whole breast curved surface including a lower curved surface and an upper curved surface of the breast. A method of manufacturing a breast reconstruction template,
Data processing step of converting 3D scan data of breast obtained by a scanner into 3D polygon data, converting the 3D polygon data into 3D CAD data, and converting the 3D CAD data into 3D solid data When,
A first three-dimensional model production step of producing a three-dimensional model for modeling the external shape and appearance for breast reconstruction by processing an NC milling machine on a high-density foam material based on the three-dimensional solid data;
Including a first template manufacturing step of pressing a softened and softened resin sheet against the first three-dimensional model and preparing a first template by vacuum molding;
Further, in order to calculate the capacity of the self-organized tissue to be filled, the three-dimensional solid data is subjected to offset data processing, and then a high-density foam material is processed by an NC milling machine, so that the site that becomes the base of the breast after the reconstruction is modeled A second three-dimensional model production step for producing a three-dimensional model
A second template preparation step of pressing a softened resin sheet in advance against the second three-dimensional model and preparing a second template by vacuum molding;
The manufacturing method of the template for breast reconstruction characterized by including these.   The method for manufacturing a breast reconstruction template according to claim 3, wherein the first three-dimensional model and the second three-dimensional model are formed by subjecting the resin sheet to vacuum molding.   The method for producing a breast reconstruction template according to claim 3, wherein the resin sheet is a thermoplastic resin having a deflection temperature (thermal deformation temperature) of 1.80 MPa in accordance with JIS K 7191-2 of 50 to 150 ° C.   The breast reconstruction template obtained by the manufacturing method of the 1st template for breast reconstruction and the 2nd template in any one of Claims 3-5. A template for breast reconstruction,
A first template for modeling the breast to be reconstructed and the external surroundings of the breast;
A breast reconstruction template comprising a second template for calculating a self-tissue filling capacity for breast reconstruction and modeling a base of the breast reconstruction. The first template for breast reconstruction according to claim 6 or 7,
A first template for breast reconstruction in which holes for injecting centrifugally treated adipose tissue are formed at a plurality of locations on the margin of the areola of the template.   Furthermore, the 1st template for breast reconstruction of Claim 8 by which the hole for inject | pouring the centrifugally-treated adipose tissue is drilled in several places of the submammary groove | channel and / or the upper breast groove | channel.   9. The first template for breast reconstruction according to claim 8, wherein holes for injecting the adipose tissue are formed at approximately 4 to 8 positions in the circumferential direction at substantially equal intervals on the edge of the areola.   Furthermore, the 1st template for breast reconstruction of Claim 9 currently opened at 4-8 places by the substantially equal interval in the perimeter direction in the lower breast groove | channel and / or the upper breast groove | channel. A medical bra for supporting a reconstructed breast including self-organized tissue,
The brassiere converts breast 3D scan data acquired by a scanner into 3D polygon data, converts the 3D polygon data into 3D CAD data, and converts the 3D CAD data into 3D solid data. Data processing process to
A first three-dimensional model production step of producing a three-dimensional model for modeling the external shape and appearance for breast reconstruction by processing the three-dimensional solid data with an NC milling machine;
Including a first template obtained by pressing a resin sheet preheated and softened against the first three-dimensional model and producing a first template by vacuum molding. Medical bra.