JP2022012107A - Breast reconstruction support guide - Google Patents

Abstract

To provide an instrument for supporting breast reconstruction regardless of the skill of an operator.SOLUTION: A manufacturing method of a breast reconstruction support guide comprises the steps of: acquiring three-dimensional shape data of a chest of a patient in a standing position or sitting position; creating three-dimensional CAD data of a breast lower part along a chest wall of the patient from the three-dimensional shape data; and manufacturing a breast reconstruction support guide with a 3D printer on the basis of the three-dimensional CAD data. By performing a breast reconstruction operation by using the breast reconstruction support guide, an IMF can be manufactured while maintaining the bilateral symmetry with the unaffected side; therefore, the IMF of the breast before excision can be reconstructed regardless of the skill of an operator.SELECTED DRAWING: Figure 2

Description

The present invention relates to an instrument used during reconstructive surgery to accurately restore the shape and size of the breast before resection during breast reconstruction.

Plastic surgery to reconstruct a breast that has been deformed or lost due to breast cancer treatment is called breast reconstruction. For women, the deformation and loss of the breast is accompanied by a great deal of mental distress, which has a great impact on the quality of life (QOL). Therefore, breast reconstruction is a pressing issue and can be said to be part of breast cancer treatment.

Breast reconstruction can be broadly divided into a method using autologous tissue (flap method) and a method using an artificial object (implant) (breast prostheses surgery, silicon implant method). The methods using autologous tissue include a free flap transplantation method in which a distant tissue such as the abdomen or thigh is used and transplanted and reconstructed by performing a blood vessel anastomosis, and a free flap transplantation method in which blood vessels in nearby tissues such as the back are not separated. There are two types of pedunculated flap transplantation methods that are moved to and reconstructed. There are several surgical procedures for the widely performed deep inferior epigastric artery perforator flap method, but in each case, it is a difficult operation to preserve nerves and muscles and perform vascular anastomosis (microsurgery). Is. In addition, it requires a high level of skill to form and restore a breast of the same size and shape as the healthy side in the autologous tissue. In addition, although the method using a silicone implant selects an implant of an appropriate size and shape from more than 100 types of implants, it requires skill to restore the implant to the same shape and size as before excision. ..

According to the statistics of the National Cancer Center, the number of breast cancer cases in 2016 was about 95,000, which is the highest number of cancer cases by site among Japanese women. On the other hand, although the number of primary reconstructions performed at the same time as breast cancer resection is increasing, it is only about 20% of the total number of mastectomy cases.

The reason why primary reconstruction remains in 20% of all mastectomy cases despite breast reconstruction, which has a significant impact on QOL for women, is that breast surgery and plastic surgery work closely together to provide medical care. Insufficient understanding and cooperation of breast surgeons has been cited, despite the need to do so. It is also said that the shortage of plastic surgeons who can handle breast reconstruction is also a factor. Unless the procedure is selected and breast reconstruction is performed, patients often do not get satisfactory results in terms of cosmeticity, and the shortage of skilled plastic surgeons is a problem.

Breast reconstruction is often influenced by the skill of the surgeon, but various ideas have been proposed so that even an inexperienced surgeon can obtain a certain result (Patent Documents 1 and 2). ). In Patent Document 1, a three-dimensional shape of a patient's chest is acquired in a standing or sitting position before breast resection, a breast model is designed from the three-dimensional shape data, and a breast reconstruction forming cup prepared from the model is used. , Disclosed that breast reconstruction is performed by filling autologous tissue along its shape. Patent Document 2 describes a first three-dimensional model for modeling the appearance and appearance for breast reconstruction from three-dimensional scan data, and a base of the breast after reconstruction for calculating the capacity of autologous tissue to be filled. A method of producing a second three-dimensional model and performing breast reconstruction using these three-dimensional models is disclosed.

JP-A-2015-54089 Japanese Unexamined Patent Publication No. 2016-214829

However, the inventions described in Patent Documents 1 and 2 are both methods of producing a three-dimensional model that imitates the outer shape and filling the autologous tissue according to the shape. Although the shape of the three-dimensional model imitates the shape of the patient's original breast, it only imitates the shape of the affected breast, and it is not possible to confirm the position and left-right symmetry with the healthy side. do not have. Therefore, there are many problems in terms of plastic surgery, such as the position of the reconstructed breast being displaced and the left-right symmetry with the healthy side being displaced, and in some cases, the patient's satisfaction cannot be obtained.

In particular, if the position of the inframammary field (IMF) shifts, it becomes difficult to wear underwear, and if the IMF curve is not symmetrical to the left and right, the patient's satisfaction cannot be obtained because it is inferior in plastic surgery. .. As mentioned above, breast reconstruction is very important because it relieves the patient's feeling of mental loss due to mastectomy and improves quality of life.

The IMF is created by stitching the back of the skin and the chest wall using absorbent threads. However, it is difficult to create an IMF that has the same position and left-right symmetry as the healthy side, and mastery is required. It is an object of the present invention to create an IMF symmetrical with the healthy side regardless of the skill of the operator, and to provide an instrument for supporting breast reconstruction with excellent plastic surgery.

The present invention relates to the following instruments used during breast reconstruction surgery and a method for producing the following instruments.
(1) A method for producing a breast reconstruction support guide used for breast reconstruction, in which a step of acquiring 3D shape data of a patient's chest in a standing or sitting position and a step of acquiring 3D shape data of the patient and the IMF and chest wall of the patient from the 3D shape data. A method for producing a breast reconstruction support guide including a step of creating a 3D CAD data including the lower part of the breast along the above and a step of creating a breast reconstruction support guide indicating the position of the IMF by a 3D printer based on the 3D CAD data. ..
(2) When the three-dimensional shape data of the chest of the patient is the data acquired after the breast resection, the step of correcting the affected side three-dimensional CAD data symmetrically based on the healthy side data is included (1). ) How to make a breast reconstruction support guide.
(3) A breast reconstruction support guide used for breast reconstruction, which has a curve along the patient's chest wall from the shape of the lower part of the breast based on the patient's chest three-dimensional shape data, and the upper part is a line along the IMF. A breast reconstruction assistance guide featuring.
(4) The breast reconstruction support guide according to (3), which is a breast reconstruction support guide used for breast reconstruction and is characterized by having gripping portions on both sides.
(5) The breast according to (3) or (4), which is a breast reconstruction support guide used for breast reconstruction and is provided with a lower breast guide that imitates the shape of the lower breast and covers it so as to wrap it. Reconstruction support guide.
(6) The breast reconstruction support guide according to (3) or (4), which is a breast reconstruction support guide used for breast reconstruction and is provided with a nipple guide indicating the height of the nipple.
(7) A breast reconstruction support guide used for breast reconstruction, a vertical nipple guide extending from the IMF line through the nipple to the upper chest, and / or a lateral direction extending from the midline through the nipple to the side. The breast reconstruction support guide according to (6), which is equipped with a nipple guide.
(8) The breast reconstruction support guide used for breast reconstruction surgery, wherein the lower breast guide or the nipple guide is removable, according to any one of (5) to (7). guide.
(9) The breast reconstruction support guide used for breast reconstruction, which includes a median guide extending upward from the IMF line along the median line, according to any one of (3) to (8). Support guide.
(10) A breast reconstruction support guide used for breast reconstruction, characterized in that a fixing hole for fixing to the skin with a suture is provided to prevent misalignment (3) to (9). One of the breast reconstruction support guides.

The figure explaining the method of making a breast reconstruction support guide. A drawing substitute photograph showing the breast reconstruction support guide of the first embodiment. The figure which shows the breast reconstruction support guide of Embodiment 2. The figure which shows the breast reconstruction support guide of Embodiment 3-6.

As will be described in detail below, the breast reconstruction support guide shown in this embodiment is an instrument for recording the position and shape of the IMF based on 3D scan data obtained from a patient. The breast reconstruction support guide may obtain 3D data before breast cancer surgery, that is, with the breast on the side from which the breast cancer is removed maintaining its original shape, or based on 3D scan data obtained from the healthy side. It may be manufactured symmetrically.

The breast reconstruction support guide shown in the following examples can be used in either case of the flap method for breast reconstruction using autologous tissue or the silicon implant method for breast reconstruction using implants. can. Breast reconstruction can be performed by creating an IMF that maintains left-right symmetry with the healthy side according to the breast reconstruction support guide prepared for each individual patient.

[Preparation of breast reconstruction support guide]
First, we will explain how to make a breast reconstruction support guide. Since the shape of the breast varies from patient to patient, a breast reconstruction support guide is tailor-made for each patient. Breast reconstruction is performed in the recumbent position, but since the IMF line originally required is in the standing or sitting position, the 3D shape data of the chest is measured in the standing or sitting position. The acquisition of the three-dimensional shape data may be performed before the breast cancer resection or after the breast cancer resection. In the case of post-breast cancer resection, the data symmetrical to the data on the healthy side with the median line as the center line may be used as the three-dimensional shape data on the affected side. For the data acquisition of the three-dimensional shape, for example, a 3D scanner capable of measuring the three-dimensional shape can be used, such as a 3D imaging analysis device Vectra (Canfield).

When breast data is acquired before breast cancer resection, the data of the left and right breasts are used, and when breast data is acquired after breast cancer resection, the healthy side data (region in FIG. 1a) is used to draw the midline. Create a breast reconstruction support guide symmetrically. Design a breast reconstruction support guide using CAD from 3D scanner data.

The upper part of FIG. 1 shows the 3D scan data of the patient, and the lower part shows the design drawing of the breast reconstruction support guide prepared based on the 3D scan data of the patient. FIG. 1 shows an example in which the patient's right side is the healthy side, and the left side is a total mastectomy performed and a tissue expander is inserted to expand the tissue. The breast reconstruction support guide 1 is created by using the 3D scan data of the lower part of the breast a on the healthy side acquired by the scanner and the data whose position and morphology are symmetrical from the median line based on the data on the healthy side as the affected side data.

The left side of FIG. 1 shows a front view of the 3D scan data of the patient as seen from the front and a breast reconstruction support guide prepared based on the 3D scan data. The right side of FIG. 1 shows the patient's 3D scan data seen from the lower left of the patient and a perspective view of the breast reconstruction support guide seen from the same position.

The upper part of the breast reconstruction support guide 1 has a curved shape along the IMF from the median guide 2 to the end point 3 on the outside of the IMF and along the chest wall. During breast reconstruction, placement along the chest wall and in close contact with the IMF on the healthy side of the patient when placed on the patient's chest can determine the location of the IMF in the breast in need of reconstruction. The width of the breast reconstruction support guide 1 may be wide enough to be stably worn by the patient during surgery. Further, here, the shape is provided with a grip portion 4 so that the breast reconstruction support guide 1 can be easily held on both sides. The grips may be arranged at both ends, on only one side, or in the center. Further, as shown in the following embodiment, the shape without a grip portion may be used depending on the shape of the breast reconstruction support guide.

A breast reconstruction support guide is created with a 3D printer based on the blueprint created by CAD. As the resin to be used, any resin such as ABS resin, PLA resin, polycarbonate, nylon, thermoplastic polyurethane, PET resin, PETG resin and the like that can be used in a 3D printer may be used. In addition, any material may be used, including materials that will be developed in the future, such as materials that are a mixture of these. However, since the material of the breast reconstruction support guide is made to order for each patient and used, durability is not required, but the following requirements must be satisfied. The breast reconstruction support guide needs to be a material that can be sterilized because it is used intraoperatively, but it must be a material that does not change its shape after sterilization. In addition, a flexible material is desirable for easy placement on the patient's chest. However, it is desirable that the material restores its shape after placement on the chest and can be placed along the patient's chest wall.

Breast reconstruction assistance guides produced by 3D printers are sterilized and used in IMF preparation. During the preparation of the IMF, the surgical assistant may fix the breast reconstruction support guide in an appropriate position, and the surgeon may prepare the IMF according to the breast reconstruction support guide. Alternatively, as illustrated in the embodiment, a hole for fixation may be created in the breast reconstruction support guide and fixed to the skin of the patient with sutures for use. In any case, since the IMF line is determined by the breast reconstruction support guide, the surgeon can sew the back side of the skin and the chest wall at an appropriate position to create the IMF line.

Next, an embodiment of the breast reconstruction support guide will be described with reference to the drawings. Since the shape of the breast varies greatly from person to person, it is possible to perform breast reconstruction with excellent plastic surgery by selecting an appropriate breast reconstruction support guide.

[Embodiment 1]
FIG. 2 shows a breast reconstruction support guide manufactured by using a 3D printer based on the CAD data created from the patient 3D shape data shown in FIG. FIG. 2 is a photograph taken from the front (A), from the upper part (B), and from the left side (C) in a state of being worn by the patient. Here, PLA resin is used for production, but as described above, the production is not limited to this, and any resin may be used.

Since it is created from the patient's 3D shape data, the breast reconstruction support guide has a shape along the patient's chest wall (see FIG. 2 (B)). Therefore, the position can be determined by placing the median guide 2 on the chest of the patient in accordance with the IMF on the healthy side, so that the IMF line 5 on the side where the excision is performed can be determined. Here, the 3D data of the patient is measured after breast cancer resection, and the IMF line on the affected side is estimated as a mirror image on the healthy side.However, the data is measured before the resection to create a breast reconstruction support guide. You can also do it.

Further, although the breast reconstruction support guide is manufactured as an integrated member by a 3D printer here, the breast reconstruction support guide may be manufactured by dividing it into two members on the left and right along the median plane and connecting them in the middle. The left and right members may be configured to be integrated and used by providing convex portions or concave portions at corresponding positions on the midline of both the left and right members and fitting them together.

The surgeon creates an IMF by sewing the back side of the skin and the chest wall with an absorbent thread along the affected side IMF line 5 of the breast reconstruction support guide 1. By creating an IMF according to the breast reconstruction support guide, it is possible to create the position and shape of the IMF line in the same way as on the healthy side. As a result, the IMF line can be created with symmetry between the healthy side and the affected side.

[Embodiment 2]
The breast reconstruction support guide of the first embodiment imitates the shape up to the left and right end points of the IMF, whereas the breast reconstruction support guide 1a of the present embodiment is the data of the region shown by b in FIG. The axillary guide 6 is provided based on the above, and the guide can be inserted to the axilla. In the second embodiment, both sides of the breast reconstruction support guide extend to the axilla, and the shape does not include a grip portion.

Since the breast reconstruction support guide 1a can insert the axillary guide 6 up to the axilla, it can be more stably fixed to the patient's chest. In some cases, sentinel lymph node biopsy and axillary lymph node dissection may cause axillary scar contracture and deform morphology. In such cases, the use of a guide that goes into the axilla makes it possible to reproduce the morphology of the axilla symmetrically when the breast is reconstructed in two stages. In addition, since reconstruction can be performed while confirming the symmetry of the lines on both sides of the breast as well as the IMF, more accurate restoration can be performed.

[Embodiment 3]
The breast reconstruction support guide 1b of the third embodiment is a breast reconstruction support guide that extends to the axilla on both sides as in the second embodiment and is provided with a lower breast guide 7 so as to wrap the breast from the IMF line to the nipple (Fig.). 4 (A)). Since it is designed to wrap around the breast, it is a guide that shows the height and size of the breast. The breast reconstruction support guide 1b of this design can reconstruct a breast closer to the original shape because the IMF line can be created and the size and shape of the affected breast can be created along the guide. ..

Further, the lower breast guide 7 can be configured to be removable as needed. Two or more protrusions or recesses are provided at the base of the lower breast guide 7, and recesses or protrusions are provided at matching positions on the IMF line of the breast reconstruction support guide, and the protrusions and recesses at the corresponding positions are fitted. It may be configured to match. When creating the IMF line, the lower breast guide 7 can be removed without getting in the way, and when it is necessary to confirm the shape of the breast, the lower breast guide 7 can be attached to perform breast reconstruction. By making it removable, it does not get in the way when creating the IMF and has good intraoperative operability.

[Embodiment 4]
The breast reconstruction support guide 1c of the fourth embodiment includes a teat guide 8 indicating the position and height of the teat (FIG. 4B). Since the breast reconstruction support guide 1b of the third embodiment is designed to wrap the breast, it is easy to grasp the shape and size of the breast, but when creating the IMF, it is difficult for the operator's hand to go all the way in. If it was difficult to operate, it had to be removed. Since the breast reconstruction support guide 1c of the fourth embodiment is configured to show only the papilla position as the papilla guide 8, it is possible to create the IMF as it is without disturbing the formation of the IMF.

Alternatively, the nipple guide 8 may have a removable configuration as needed, similar to the lower breast guide shown in the third embodiment. Two or more protrusions or recesses are provided at the base of the nipple guide 8, recesses or protrusions are provided at matching positions on the IMF line of the breast reconstruction support guide, and the protrusions and recesses at the corresponding positions are removable. It may be configured to fit into. Alternatively, the base of the nipple guide 8 may be made longer than the actual size, and the base may be fixed with medical tape or the like so as to be removable when the IMF line is made.

[Embodiment 5]
The breast reconstruction support guide 1d of the fifth embodiment includes a median guide 2a further extended in the configuration of the breast reconstruction support guide of the fourth embodiment (FIG. 4 (C)). By providing the longer midline guide 2a, the IMF line can be accurately aligned without shifting. In addition, it does not shift during the operation. Further, in this configuration, a fixing hole 9 for fixing the breast reconstruction support guide with a suture during the operation is provided. The provision of the fixation hole 9 eliminates the need for the assistant to hold down the breast reconstruction support guide.

[Embodiment 6]
In the breast reconstruction support guide 1e of the sixth embodiment, the papilla guides (8a, 8b) are formed vertically and horizontally (FIG. 4 (D)). The longitudinal papilla guide 8a extends from the IMF line through the papilla to the upper chest. The lateral papilla guide 8b has a shape extending horizontally from the median line through the papilla to the side. Since the shape of the breast can be grasped from the vertical and horizontal directions, it is easy to form a shape symmetrical to the healthy side. Further, the papilla guides 8a and 8b can be configured to be removable when the IMF is formed. Further, although the configuration including the vertical and horizontal teat guides 8a and 8b is shown here, only one of the vertical and horizontal teat guides may be provided as a configuration.

The breast reconstruction support guide shown in the above embodiments can be adopted according to the patient. The breast reconstruction support guides 1 and 1a of the first and second embodiments are the simplest guides and are for reproducing the left-right symmetry of the IMF. Suitable for breast reconstruction in patients with breast morphology that is not large in volume and has no ptosis. The breast reconstruction support guides 1b, 1c, 1d, and 1e shown in the third to sixth embodiments serve as guides for reproducing the left-right symmetry of the morphology from the IMF to the top. The breast reconstruction support guide 1b of Embodiment 3 is relatively voluminous and suitable for breast morphology with ptosis. Further, since the breast reconstruction support guide 1e of the sixth embodiment can reproduce the left-right symmetry of the line from the top to the upper chest, it has a firm volume up to the upper chest and is suitable for a breast morphology with drooping. There is. It is possible to select the form of the breast reconstruction support guide according to the form of the breast to be reconstructed, and the breast reconstruction can be performed more accurately.

Although various embodiments have been shown above, the breast reconstruction support guide may be a combination thereof without being limited to the above embodiments. For example, as shown in the first embodiment, various variations suitable for the patient or the operator can be prepared and used, such as providing a fixation hole or a nipple guide in the breast reconstruction support guide to the end point of the IMF.

By using the Breast Reconstruction Assistance Guide, it is possible to create an IMF line that is close to the patient's original condition, regardless of the skill of the surgeon. It is also possible to select a breast reconstruction support guide that shows the position of the shape of the nipple or breast depending on the skill of the operator and the condition of the patient. Therefore, the breast reconstruction support guide not only makes the IMF line symmetrical with the healthy side, but also enables breast reconstruction with more symmetry with the healthy side, so that breast reconstruction with excellent plastic surgery can be performed.

1, 1a, 1b, 1c, 1d, 1e ... Breast reconstruction support guide, 2, 2a ... Midline guide, 3 ... IMF end point, 4 ... Grip, 5 ... IMF line, 6 ... axillary guide, 7 ... lower breast guide, 8, 8a, 8b ... papilla guide, 9 ... fixation hole

Claims (10)

It is a method of making a breast reconstruction support guide used for breast reconstruction.
The process of acquiring 3D shape data of the chest of a standing or sitting patient,
A step of creating 3D CAD data including the IMF of the patient and the lower part of the breast along the chest wall from the 3D shape data, and
A method for producing a breast reconstruction support guide, which comprises a step of producing a breast reconstruction support guide indicating the position of the IMF by a 3D printer based on the three-dimensional CAD data. If the three-dimensional shape data of the patient's chest is the data acquired after mastectomy,
The method for producing a breast reconstruction support guide according to claim 1, which comprises a step of symmetrically correcting the affected side 3D CAD data based on the healthy side data. A breast reconstruction support guide used for breast reconstruction,
From the shape of the lower part of the breast based on the patient's chest 3D shape data
With a curve along the patient's chest wall
A breast reconstruction support guide featuring a line along the IMF at the top. A breast reconstruction support guide used for breast reconstruction,
The breast reconstruction support guide according to claim 3, wherein the breast reconstruction support guide is provided on both sides. A breast reconstruction support guide used for breast reconstruction,
The breast reconstruction support guide according to claim 3 or 4, further comprising a lower breast guide that imitates and covers the shape of the lower breast. A breast reconstruction support guide used for breast reconstruction,
The breast reconstruction support guide according to claim 3 or 4, further comprising a nipple guide indicating the height of the nipple. A breast reconstruction support guide used for breast reconstruction,
The breast reconstruction support guide according to claim 6, comprising a vertical nipple guide extending from the IMF line through the nipple to the upper chest and / or a lateral nipple guide extending from the midline through the nipple to the side. .. A breast reconstruction support guide used for breast reconstruction,
The breast reconstruction support guide according to any one of claims 5 to 7, wherein the lower breast guide or the nipple guide is removable. A breast reconstruction support guide used for breast reconstruction,
The breast reconstruction support guide according to any one of claims 3 to 8, further comprising a median guide extending upward from the IMF line along the median line. A breast reconstruction support guide used for breast reconstruction,
The breast reconstruction support guide according to any one of claims 3 to 9, wherein a fixing hole for fixing to the skin with a suture is provided to prevent misalignment.

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