JP2015054089A - Method for manufacturing forming cup for breast reconstruction and forming cup for breast reconstruction - Google Patents

Method for manufacturing forming cup for breast reconstruction and forming cup for breast reconstruction Download PDF

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JP2015054089A
JP2015054089A JP2013188940A JP2013188940A JP2015054089A JP 2015054089 A JP2015054089 A JP 2015054089A JP 2013188940 A JP2013188940 A JP 2013188940A JP 2013188940 A JP2013188940 A JP 2013188940A JP 2015054089 A JP2015054089 A JP 2015054089A
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breast
model
forming cup
patient
reconstruction
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泰孝 梅本
Yasutaka Umemoto
泰孝 梅本
裕司 森下
Yuji Morishita
裕司 森下
幸栄 大野
Yukie Ono
幸栄 大野
香代 宮木
Kayo Miyaki
香代 宮木
美穂子 足立
Mihoko Adachi
美穂子 足立
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EKUSHIIRU CORP KK
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Abstract

PROBLEM TO BE SOLVED: To provide a method for manufacturing a forming cup for breast reconstruction capable of restoring and adjusting a patient's own tissue collected from the patient in accordance with the size and shape of the breast before the excision irrespective of the skill of an operator and reducing the time for restraining the patient and the burden on the patient, and also to provide a forming cup for breast reconstruction prepared by the method.SOLUTION: A method for manufacturing a forming cup for breast reconstruction 50 which is filled with a patient's own tissue 30 and is restored and adjusted in accordance with the size and shape of the breast before the excision, comprises the steps of: acquiring a three-dimensional shape of a breast before excision of a patient in a standing or sitting position; designing a model of the breast from the three-dimensional shape data of the three-dimensional shape; manufacturing the model of the breast on the basis of the design data; covering the model with a plastic film softened by heating and bringing the plastic film into close contact with the model; and cooling the plastic film and removing the plastic film from the model.

Description

本発明は、自家組織を使用して乳房再建を行う際、自家組織を充填して患者の切除前の乳房の形状・大きさに調整し復元するために使用される乳房再建用フォーミングカップの作製方法及び当該方法で作製される乳房再建用フォーミングカップに関する。   The present invention, when performing breast reconstruction using autologous tissue, makes a foaming cup for breast reconstruction used for filling the autologous tissue and adjusting and restoring the shape and size of the breast before excision of the patient. The present invention relates to a method and a forming cup for breast reconstruction produced by the method.

乳癌等により乳房の切除を受けた患者の乳房の喪失感に起因する精神的苦痛は大きく、QOLの低下を招くことがある。そのため、従来から乳房をできるだけ元の状態に戻すことによりQOLの向上が期待される乳房再建が施行されている。乳房再建は、胸部に人工乳房(インプラント)を埋め込み乳房を再建する方法や胸部に自家組織を挿入して乳房を再建する方法(以下、「自家組織再建」という)がある。   Psychological distress due to breast loss in patients who have undergone breast resection due to breast cancer or the like is significant and may lead to a decline in quality of life. For this reason, breast reconstruction that has been expected to improve QOL by returning the breast to its original state as much as possible has been performed. Breast reconstruction includes a method of reconstructing a breast by embedding an artificial breast (implant) in the chest and a method of reconstructing the breast by inserting an autologous tissue into the chest (hereinafter referred to as “self-tissue reconstruction”).

大胸筋が温存されていない場合を含む乳房の切除を受けた症例の多くに適用できる自家組織再建は、採取した患者の自家組織を切除前の乳房の形状・大きさに調整する作業が必要となる。従来、切除前の乳房や切除されていない残存する乳房を模して術者の勘や経験により自家組織を切除前の乳房の形状・大きさに調整する作業が行われている。また、自家組織を切除前の乳房の形状・大きさに調整する作業に用いられるものとして、シリコーンゴムを切除前の乳房の表面に肉盛りし、硬化させた後に乳房から取り外すことにより乳房が転写される乳房雌型がある(特許文献1参照)。   Autologous tissue reconstruction that can be applied to many cases that have undergone breast resection, including cases in which the pectoral muscle is not preserved, requires adjustment of the collected patient's own tissue to the shape and size of the breast before resection It becomes. Conventionally, an operation of adjusting an autologous tissue to a shape and size of a breast before excision is performed by an operator's intuition and experience, imitating a breast before excision and a remaining breast that has not been excised. In addition, as a material used to adjust the autologous tissue to the shape and size of the breast before excision, the breast is transferred by placing silicone rubber on the surface of the breast before excision, curing it, and then removing it from the breast. There is a female breast type (see Patent Document 1).

特開2013−330(請求項1、請求項5、段落〔0019〕〜段落〔0022〕)JP2013-330 (Claim 1, Claim 5, Paragraph [0019] to Paragraph [0022])

しかし、従来の切除前の乳房や切除されていない残存する乳房を模して自家組織を乳房の形状・大きさに調整する作業は、術者の技量に大きく左右され、切除前の乳房の形状・大きさに復元することが難しいことがある。
また、特許文献1に記載の乳房雌型は、乳房がシリコーンゴムの重みで下に押さえられるため、下垂した状態に変形した乳房が転写され、硬化したシリコーンゴムを乳房から取り外した後に修正を加えるとしても、切除前の乳房の形状に再現できず、乳房雌型の使用により切除前の乳房の形状に復元できないことや、左右の乳房のバランスがとれなくなることがある。また、患者はシリコーンゴムが硬化するまで拘束され負担となる。
However, the work of adjusting the self-tissue to the shape and size of the breast, simulating the breast before the resection or the remaining unremoved breast, depends greatly on the skill of the operator, and the shape of the breast before the resection・ It may be difficult to restore the size.
Moreover, since the breast is pressed down by the weight of the silicone rubber in the breast female mold described in Patent Document 1, the deformed breast is transferred to the drooping state, and correction is made after removing the cured silicone rubber from the breast. However, the shape of the breast before excision cannot be reproduced, and the breast shape before excision cannot be restored due to the use of a female breast, and the right and left breasts may not be balanced. In addition, the patient is restrained and burdened until the silicone rubber is cured.

本発明は、上記の事情に鑑みなされたもので、術者の技量に左右されることなく、患者から採取された自家組織を充填して切除前の乳房の形状・大きさに調整し復元することができ、かつ患者の拘束時間が短く患者の負担が軽減される乳房再建用フォーミングカップの作製方法及び当該方法で調整される乳房再建用フォーミングカップを提供することを課題とする。   The present invention has been made in view of the above-described circumstances. The self-tissue collected from the patient is filled and adjusted to the shape and size of the breast before resection and restored without depending on the skill of the operator. It is an object of the present invention to provide a method for producing a breast reconstruction foaming cup that can be reduced and the burden on the patient is reduced, and a breast reconstruction foaming cup that is adjusted by the method.

本発明の発明者等は、上記の課題を解決するために鋭意検討を重ねた結果、本発明に想到した。
すなわち、本発明は、自家組織を充填して患者の切除前の乳房の形状・大きさに調整し復元するために用いられる乳房再建用フォーミングカップの作製方法であって、立位又は座位の患者の切除前における胸部の3次元形状を取得するステップと、当該3次元形状の3次元形状データから胸部の模型を設計するステップと、設計データに基づき胸部の前記模型を作製するステップと、加熱により柔らかくされたプラスチックフイルムを前記模型に被覆し密着させるステップと、前記プラスチックフィルムを冷却後に前記模型から取り外すステップと、を有することを特徴とする乳房再建用フォーミングカップの作製方法を要旨とする。
The inventors of the present invention have come up with the present invention as a result of intensive studies to solve the above-mentioned problems.
That is, the present invention relates to a method for producing a breast reconstruction foaming cup used for filling an autologous tissue to adjust and restore the shape and size of the breast before excision of the patient. Obtaining a three-dimensional shape of the chest before excision, designing a chest model from the three-dimensional shape data of the three-dimensional shape, producing the chest model based on the design data, and heating The gist of the present invention is a method for producing a forming cup for breast reconstruction, comprising the steps of covering and closely attaching a softened plastic film to the model and removing the plastic film from the model after cooling.

上記の構成の発明は、切除前の立位又は座位の乳房の形状・大きさを正確に再現できる乳房再建用フォーミングカップを作製できる。なお、「患者の切除前の乳房」には、片側の乳房の切除後に残存する乳房を包含する。「胸部」とは乳房を含む胸の部分をいう。また、乳房再建が施行されるのは、乳癌の手術で乳房を切除した場合に限らず、外傷や奇形等で乳房を切除した場合も含まれる。   The invention with the above configuration can produce a breast reconstruction forming cup that can accurately reproduce the shape and size of the breast in the standing or sitting position before resection. Note that “the breast before excision of the patient” includes a breast remaining after excision of one of the breasts. “Chest” refers to the part of the breast that includes the breast. Breast reconstruction is performed not only when the breast is removed by breast cancer surgery, but also when the breast is removed due to trauma or malformation.

上記の発明において、模型を設計するステップで切除されずに残存する乳房の3次元形状を切除側に反転させてもよい。また、上記の発明において、プラスチックフィルムは透明でもよい。   In the above invention, the three-dimensional shape of the breast that remains without being excised in the step of designing the model may be reversed to the excision side. In the above invention, the plastic film may be transparent.

上記の方法で作製される乳房再建用フォーミングカップを要旨とする。   The gist of the forming cup for breast reconstruction produced by the method described above.

本発明の方法によれば、患者の切除前における立位又は座位の乳房の形状・大きさを正確に再現できるので、自家組織を充填して調整することにより切除前の立位又は座位の乳房の形状・大きさに復元することができる乳房再建用フォーミングカップを作製できる。
また、本発明の方法によれば、3Dスキャナー等の3次元形状測定機で患者の胸部を撮影するだけでよいので、患者の拘束時間が短く患者の負担を軽減して乳房再建用フォーミングカップを作製できる。
According to the method of the present invention, the shape and size of the breast in the standing or sitting position before excision of the patient can be accurately reproduced. Therefore, the breast in the standing or sitting position before excision can be obtained by filling and adjusting the self-tissue. A forming cup for breast reconstruction that can be restored to the shape and size of the breast can be produced.
In addition, according to the method of the present invention, it is only necessary to photograph a patient's chest with a three-dimensional shape measuring machine such as a 3D scanner, so that the patient's restraint time is short and the burden on the patient is reduced. Can be made.

本発明の乳房再建用フォーミングカップによれば、患者の切除前における立位又は座位の乳房の形状・大きさに復元された乳房を自家組織を使用して再建することができる。   According to the forming cup for breast reconstruction of the present invention, the breast restored to the shape and size of the breast in the standing or sitting position before the excision of the patient can be reconstructed using the autologous tissue.

本発明に係る乳房再建用フォーミングカップの正面図である。It is a front view of the forming cup for breast reconstruction concerning the present invention. 本発明に係る乳房再建用フォーミングカップの平面図である。It is a top view of the forming cup for breast reconstruction concerning the present invention. 模型にプラスチックフィルムを被覆し、真空で吸引する状態を示す説明図である。It is explanatory drawing which shows the state which coat | covers a model with a plastic film and attracts | sucks with a vacuum. 自家組織が充填された状態の本発明に係る乳房再建用フォーミングカップの正面図である。It is a front view of the foaming cup for breast reconstruction which concerns on this invention of the state with which the autologous tissue was filled.

以下、本発明に係る乳房再建用フォーミングカップ50の作製方法及び乳房再建用フォーミングカップ50について、図面を参照して説明する。   Hereinafter, a method for producing a forming cup 50 for breast reconstruction and a forming cup 50 for breast reconstruction according to the present invention will be described with reference to the drawings.

立位又は座位の患者における胸部の3次元形状の取得は、3Dスキャナー等3次元形状を数値で測定する3次元形状測定機を用いて行うことができる。3Dスキャナーは、胸部の3次元形状の取得ができる限り特に限定されず、市販のものを使用することができる。   Acquisition of a three-dimensional shape of the chest in a patient in a standing or sitting position can be performed using a three-dimensional shape measuring machine that measures the three-dimensional shape numerically, such as a 3D scanner. The 3D scanner is not particularly limited as long as the three-dimensional shape of the chest can be acquired, and a commercially available one can be used.

上記で得られた3次元形状の3次元形状データから3DCAD等を用い、図3に示す胸部の模型20を設計することができる。片側の乳房の削除後に胸部の模型20を設計する場合、削除されずに残存する乳房の3次元形状を切除側に反転させることにより行うことができる。
これにより残存する乳房を切除された乳房として再現することができる。3DCADは、3次元形状データから胸部の模型20が設計できる限り特に限定されず、市販のものを使用することができる。
The chest model 20 shown in FIG. 3 can be designed from 3D shape data of the 3D shape obtained above using 3DCAD or the like. When designing the chest model 20 after the removal of one breast, it can be performed by inverting the three-dimensional shape of the remaining breast without being removed to the resection side.
As a result, the remaining breast can be reproduced as a resected breast. The 3D CAD is not particularly limited as long as the chest model 20 can be designed from the three-dimensional shape data, and a commercially available product can be used.

次に、3DCAD等による設計データに基づき、NCマニシング加工や3Dプリンター等により図3に示す胸部の模型20を作製することができる。胸部の模型20を作製するために使用する素材は、プラスチックやセラミックス等を挙げることができるが、熱で変形しない限りこれらに限定されない。NCマニシング加工に使用する装置は、設計データに基づき、プラスチックやセラミックス等の素材から胸部の模型20を切削加工できり限り特に限定されず、市販のものを使用することができる。また、3Dプリンターは、設計データに基づき、胸部の模型20を出力できる限り特に限定されず、市販のものを使用することができる。   Next, the chest model 20 shown in FIG. 3 can be produced by NC machining, 3D printer, or the like based on design data by 3D CAD or the like. Examples of the material used for producing the chest model 20 include plastics and ceramics, but are not limited to these as long as they are not deformed by heat. The apparatus used for NC machining is not particularly limited as long as the chest model 20 can be cut from a material such as plastic or ceramics based on the design data, and a commercially available apparatus can be used. The 3D printer is not particularly limited as long as it can output the chest model 20 based on the design data, and a commercially available one can be used.

また、上記の3次元形状データからの胸部の模型20の設計、設計データに基づく胸部の模型20の作製は、3DCAD/CAMシステムを用いて行うこともできる。3DCAD/CAMシステムは、胸部の模型20の設計及び作製ができる限り特に限定されず、市販のものを使用することができる。   Further, the design of the chest model 20 from the above three-dimensional shape data and the production of the chest model 20 based on the design data can also be performed using a 3D CAD / CAM system. The 3D CAD / CAM system is not particularly limited as long as the chest model 20 can be designed and manufactured, and a commercially available product can be used.

次に、作製された胸部の模型20には、図3に示すように、加熱により柔らかくされたプラスチックフィルム25が被覆され、胸部の模型20とプラスチックフィルム25の間を図示しない真空ポンプで矢印の方向に吸引することによりプラスチックフィルム25が密着する。冷却後、プラスチックフィルム25を胸部の模型20から取り外すことにより乳房再建用フォーミングカップ50を作製できる。プラスチックフィルム25としては、ポリプロピレン、ポリエチレン、ポリエチレンテレフタレート、ポリスチレン、ポリ塩化ビニル等が挙げられるが、熱可塑性樹脂のフィルムであれば特に限定がない。また、プラスチックフイルム25は、透明であることが好ましい。プラスチックフイルム25が透明であると、乳房部1に自家組織30を充填した乳房再建用フォーミングカップ50を顔の上に持ち上げることにより、自家組織30を乳房再建用フォーミングカップ50の下からも見ることができるので、乳房再建用フォーミングカップ50の上下から見て自己組織の調整作業が行え、乳房の形状・大きさをより正確に再現することや手術時間の短縮化に資することが可能となる。プラスチックフィルム25は、通常、200〜300℃で加熱されるが、使用するプラスチックフィルム25が模型に被覆可能な状態に柔らかくできる限り、この温度に限定されない。   Next, as shown in FIG. 3, the produced chest model 20 is covered with a plastic film 25 softened by heating, and a gap between the chest model 20 and the plastic film 25 is indicated by an arrow (not shown) by a vacuum pump. The plastic film 25 adheres by sucking in the direction. After cooling, the forming cup 50 for breast reconstruction can be produced by removing the plastic film 25 from the chest model 20. Examples of the plastic film 25 include polypropylene, polyethylene, polyethylene terephthalate, polystyrene, and polyvinyl chloride, but there is no particular limitation as long as it is a thermoplastic resin film. The plastic film 25 is preferably transparent. When the plastic film 25 is transparent, the self-tissue 30 can be seen from below the breast reconstruction foaming cup 50 by lifting the breast reconstruction foaming cup 50 filled with the autologous tissue 30 in the breast part 1 onto the face. Therefore, the self-organizing work can be adjusted when viewed from above and below the breast reconstruction forming cup 50, and the shape and size of the breast can be reproduced more accurately and the operation time can be shortened. The plastic film 25 is usually heated at 200 to 300 ° C., but is not limited to this temperature as long as the plastic film 25 to be used can be softened so that it can be covered with a model.

上記のように作製された乳房再建用フォーミングカップ50は、図1及び図2に示すように、乳房部1と周囲部2とから構成される。乳房部1は、患者の立位又は座位の切除前における乳房の形状・大きさが正確に再現される凹部からなり、乳頭部3及び乳輪部4には乳頭及び乳輪が再現されている。このように作製される乳房再建用フォーミングカップ50は、患者の立位又は座位の切除前における乳房の形状・大きさに調整し復元して乳房を再建することが可能となる。   As shown in FIGS. 1 and 2, the breast reconstruction forming cup 50 manufactured as described above includes a breast part 1 and a peripheral part 2. The breast part 1 is composed of a concave part that accurately reproduces the shape and size of the breast before the patient stands or sits and the breast part 1 and the areola part 4 reproduce the teat and the areola. . The breast reconstruction forming cup 50 manufactured in this way can be adjusted and restored to the shape and size of the breast before the patient's standing or sitting position is removed, and the breast can be reconstructed.

次いで、本発明に係る乳房再建用フォーミングカップ50の使用方法を説明する。まず、手術室において、滅菌処理された乳房再建用フォーミングカップ50の乳房部1の形状・大きさから予測して乳房の再建に必要な患者の自家組織30の所定量を採取し、図4に示すように、乳房再建用フォーミングカップ50の乳房部1に充填する。自家組織30は、広背筋皮弁の場合は背中の皮膚・脂肪・筋肉の一部を、腹直筋皮弁の場合は腹部の皮膚・脂肪・筋肉の一部を、遊離皮弁の場合は腹部の皮膚・脂肪を採取する。そして、乳房再建用フォーミングカップ50の乳房部1からはみ出した分の自家組織30を切除したり、自家組織の厚みが薄い場合は、はみ出した分を折り返し、切除箇所や折り返し箇所を縫合する。自家組織30は、切除前の乳房の形状・大きさを正確に復元できるように調整を行う。次に、調整された自家組織30を患者の胸部に挿入し、胸部の組織に縫合することにより乳房の再建を行うことができる。また、自家組織30の採取に先立ち、乳房再建用フォーミングカップ50の乳房部1にシリコンを充填して作製した図示しないフォーミングモデルを利用することにより、採取する皮弁の形状、大きさ、採取量あるいは自家組織30を胸部に縫合する位置等を予め的確に確認することもできる。なお、乳頭・乳輪の再建は、一般的に乳房の再建が行われてから数ヶ月を経てから行われる。また、乳房切除により胸部に十分な皮膚が残っていない場合、予め乳房の切除箇所にエキスパンダーを挿入し、組織を徐々に伸展させてから乳房再建を行ってもよい。   Next, a method of using the breast reconstruction forming cup 50 according to the present invention will be described. First, in the operating room, a predetermined amount of the patient's own tissue 30 necessary for the reconstruction of the breast is collected, as predicted from the shape and size of the breast portion 1 of the sterilized forming cup 50 for breast reconstruction, as shown in FIG. As shown, the breast portion 1 of the breast reconstruction forming cup 50 is filled. In the case of the latissimus dorsi flap, the autologous tissue 30 is a part of the skin / fat / muscle on the back, in the case of the rectus abdominal flap, the part of the skin / fat / muscle in the abdomen, Collect abdominal skin and fat. Then, the part of the self tissue 30 that protrudes from the breast part 1 of the breast reconstruction forming cup 50 is excised, or when the thickness of the self tissue is thin, the part that protrudes is folded back, and the excised part and the folded part are stitched. The autologous tissue 30 performs adjustment so that the shape and size of the breast before excision can be accurately restored. The adjusted autologous tissue 30 can then be inserted into the patient's chest and sutured to the chest tissue to rebuild the breast. Further, by using a forming model (not shown) prepared by filling the breast portion 1 of the breast reconstruction forming cup 50 with silicon prior to the collection of the self-tissue 30, the shape, size, and amount of collection of the flaps to be collected are used. Or the position etc. which sew the autologous tissue 30 to a chest can also be confirmed accurately beforehand. In general, the nipple and areola are reconstructed several months after the reconstruction of the breast. If sufficient skin does not remain in the chest due to mastectomy, an expander may be inserted in advance at the breast excision site, and the tissue may be gradually expanded before breast reconstruction.

1 乳房部
2 周囲部
20 模型
25 プラスチックフィルム
30 自家組織
50 乳房再建用フォーミングカップ
DESCRIPTION OF SYMBOLS 1 Breast part 2 Peripheral part 20 Model 25 Plastic film 30 Self organization 50 Breast reconstruction forming cup

Claims (4)

自家組織を充填して患者の切除前の乳房の形状・大きさに調整し復元するために用いられる乳房再建用フォーミングカップの作製方法であって、立位又は座位の患者の切除前における胸部の3次元形状を取得するステップと、当該3次元形状の3次元形状データから胸部の模型を設計するステップと、設計データに基づき胸部の前記模型を作製するステップと、加熱により柔らかくされたプラスチックフイルムを前記模型に被覆し密着させるステップと、前記プラスチックフィルムを冷却後に前記模型から取り外すステップと、を有することを特徴とする乳房再建用フォーミングカップの作製方法。   A method of making a breast reconstruction foaming cup used for filling and reconstructing the breast shape and size before resection of a patient by filling the autologous tissue. A step of acquiring a three-dimensional shape, a step of designing a chest model from the three-dimensional shape data of the three-dimensional shape, a step of producing the model of the chest based on the design data, and a plastic film softened by heating. A method for producing a forming cup for breast reconstruction, comprising: covering and closely contacting the model; and removing the plastic film from the model after cooling. 模型を設計するステップは、切除されずに残存する乳房の3次元形状を切除側に反転させることを含むものであることを特徴とする請求項1に記載の乳房再建用フォーミングカップの作製方法。   The method of producing a forming cup for breast reconstruction according to claim 1, wherein the step of designing the model includes reversing the three-dimensional shape of the breast that remains without being excised to the excision side. プラスチックフィルムは、透明であることを特徴とする請求項1又は請求項2に記載の乳房再建用フォーミングカップの作製方法。   The method for producing a forming cup for breast reconstruction according to claim 1 or 2, wherein the plastic film is transparent. 請求項1〜請求項3に記載の方法で作製されることを特徴とする乳房再建用フォーミングカップ。   A forming cup for breast reconstruction, which is produced by the method according to claim 1.
JP2013188940A 2013-09-12 2013-09-12 Method for manufacturing forming cup for breast reconstruction and forming cup for breast reconstruction Pending JP2015054089A (en)

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US10334892B2 (en) 2017-11-16 2019-07-02 Hubbard Innovations, Inc. Chest wall adapter device and method of use
US10492545B2 (en) 2017-11-16 2019-12-03 Hubbard Innovations, Inc. Chest wall adapter device
WO2021125851A1 (en) * 2019-12-20 2021-06-24 (주)시안솔루션 Method and program for modeling custom breast prosthesis
US11399578B2 (en) 2017-11-16 2022-08-02 Hubbard Innovations, Inc. Chest wall adapter device

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JPH04327204A (en) * 1991-04-23 1992-11-16 Uchida Giken:Kk Replication of a part of human body
JP2002345860A (en) * 2001-05-25 2002-12-03 Sato Giken:Kk Production method for body's artificial prosthetic appliance
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10334892B2 (en) 2017-11-16 2019-07-02 Hubbard Innovations, Inc. Chest wall adapter device and method of use
US10492545B2 (en) 2017-11-16 2019-12-03 Hubbard Innovations, Inc. Chest wall adapter device
US11399578B2 (en) 2017-11-16 2022-08-02 Hubbard Innovations, Inc. Chest wall adapter device
WO2021125851A1 (en) * 2019-12-20 2021-06-24 (주)시안솔루션 Method and program for modeling custom breast prosthesis

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