WO2020141340A1 - Mark stencil and method for marking correct incision lines in reduction mammaplasty surgery - Google Patents

Abstract

The present invention includes technique of design and making breast marking stencil and specify the required amount of breast tissue for extract from the breast and also engineering and simulating technique as well as technical calculation which are aiding method and engineering apparatus for successful reduction mammoplasty surgery. It is not a method of surgery singly, but rather a method for a correct predict required amount of removed tissue and also correct design for making required stencil in order to have proper marking of incision lines in on breast organ. This invention discloses a method for calculation the required amount of the breast tissue volume to extract from breast during the surgery in order to achieve pre-designed result by engineering software.

Description

THE TITLE OF THE INVENTION:

MARK STENCIL AND METHOD FOR MARKING CORRECT INCISION LINES IN REDUCTION

MAMMAPLASTY SURGERY

TECHNICAL FIELD OF THE INVENTION:

This invention related to geometrical shape marking and apparatus for drawing Incision Lines on breast skin for the best results of Pre-designed surgery and a method for the prediction of the final shape of breast after reduction mammaplasty and it is related to method of Calculation for the correct reduction of the breast tissue in reduction mammaplasty surgery.

BACKGROUND OF THE INVENTION:

In breast reduction mammaplasty, it is required to draw hypothetical lines on the breast to indicate skin incision lines for making the shape of breast normal and causing the nipple position to be symmetric and balanced. During surgery, the geometrical shape lines of incision and removing breast tissue has a significant effect on the final shape and position of breast. In most cases, drawing line on breast skin when the case is in standing posture helps the surgeon to determine the geometrical shape and location of incision. However, during surgery, the surgeon has to estimate the amount of breast tissues which is supposed to be removed, or change the size and location of incision. This problem usually causes that the breasts shape to be out of their normal position, whether upper or lower, after the total reduction mammaplasty surgery. On the other hand, it is also hard to have symmetry between the position of both nipple and the hypothetical symmetric line of body. Reduction Mammaplasty is carried out mostly in the patients with excessively large breasts or in those ones suffering from imbalance of the breast shape or asymmetry of breasts. Excessively large breasts cause pain in spine and neck, and abnormal dropping breast (ptosis) causes some disorders in the organs under the breasts. As the patient requesting for breast cosmetic surgery has no correct idea about the final shape of her organ, or the position of the nipples, Reduction mammoplasty is performed usually based on the simple drawings depicted by the surgeon or on the patient’s mental image of her body after surgery. The dissatisfaction of the patient about the final shape of her breasts is one of the major postsurgical problems which may intensify the mental problems of the case even more than its pre-surgical conditions. There are several methods for breast volume reduction, by reduction mammoplasty surgery which excess tissues are removed, breast shape and nipples position are changed. During all these procedures, the surgeon marks incision lines on the breast skin of the patient to determine the incision area. Related to surgeon idea we can use different methods in this surgery operation. Areola incision around the halo of breast relates to measure final size of mention part after surgery. The surgeon can draw smaller circle around the nipple, considering the final halo size a little smaller than first size, if needed. On the other part, make an incision in the shape of a keyhole determine the correct location of removal skin and also required removal area.

Inverted T Incision Pattern is a common technique of mammaplasty, by which the breast meridian is marked based on the midclavicular line. The breast meridian passes usually through the nipples. The new position of the areola with the diameter of 44 to 45 mm is marked.

Skin incision lines are marked based on the intended method and shape. The use of this technique depends on the surgeon’s skill and experience and in cases of asymmetric breasts, the surgeon has to remove more tissues to change the location of the nipples, and stitch the breast skin. If the surgeon cannot correctly decide about the marked geometric lines, there is high risk of deformation of the breasts after surgery.

In a file submitted to the United States Patent and Trademark Office (USPTO) by Leroy Young under the No. US 12/178, 417, a marker template has been proposed for breast reduction surgery, by which a paper sheet is used with a keyhole pattern for marking of breast incision. This invention was registered and published under No. US7752768 B2 at the USPTO.

In another file submitted to the USPTO by Krishna Narayanan under No. 07/270,420 and disclosed under No. US4892096 A in the US, a solution was proposed for marking breast areola.

In addition, Robert F. Bloom invented an apparatus and method for marking the breasts before surgery. This innovation was disclosed under No. US4944737. Donald Keenan filed a method for pre-surgical breast marking at the USPTO and it was disclosed under No. US20070141972 Al.

In another file submitted to the USPTO by Michael J. Breiner under No. US 5676161 A, an apparatus and pattern was introduced for pre-surgical breast marking. DESCRIPTION OF THE INVENTION:

The present invention includes technique of design and making breast marking stencil and specify the required amount of breast tissue for extract from the breast and also engineering and simulating technique as well as technical calculation which are aiding method and engineering apparatus for successful reduction mammoplasty surgery. It is not a method of surgery singly, but rather a method for a correct predict required amount of removed tissue and also correct design for making required stencil in order to have proper marking of incision lines in on breast organ.

This invention discloses a method for calculation the required amount of the breast tissue volume to extract from breast during the surgery in order to achieve pre-designed result by engineering software. The formula for calculating required volume to be extracted from the breast tissue is as follow:

The volume of the extracted tissue= the volume of new breast - The volume of old breast

In this invention There is at least a 3-D scanner such as optical beam scanner, ultrasonic scanner, laser scanner, or a combination of these technologies can be used for 3-dimensional scanning, or software programs or any hardware can be employed to simulate the 2-dimensional images to prepare the software simulated images of the patient’s body. This method can be used for image processing or direct scan of the patient’s body in standing, sitting, supine, or prone posture with handing breasts. The best position is the standing posture. Moreover, this scanner can move around the patient up to 180- 360°, or use a fixed scanner and turn the patient’s bed equipped with a servomotor in front of the scanner. In addition, the scanner can rotate around the breasts of the patient or the involved organs of the patient is molded, and the mold is scanned and the patient’s organs are marked to extract the marked points and the body shape of the patient before surgery by the above-mentioned software program.

Considering that the best position for scanning is standing posture using rotating scanner, the above issues were expressed to show that this invention is able to do any type of scanning and create a software file of the patient’s body.

At first the patient’s breast gets scanned by a 3D digital scanner in order to create a high quality 3D model, the result is later imported to a 3D design software, then the surgeon, the patient and a 3D designer expert, Having the patient describe what she deems as desirable, and doctor assessing the health aspect of what the patient wants making sure there will not be any harmful health issues associated with the desired breasts shape and size, and all while the designer is applying changes to the 3D model. They decide on the final form Together. Then 3d designed model is printed by a 3D printer in real scale. The incision marking stencil is made by pouring mix of silicon and hardener on the final 3D printed of the desired shape and size of the breast as the expected outcome. The molded silicon then is cut according to the surgical technique intended to be used by the surgeon (eg; Inverted T method).

In order to produce the marking stencil, we need to design the ideal form of breast after surgery in engineering software and by using this 3D model we can produce a statue of ideal breast by 3D printer then we can pure a tick layer of mixed silicon with hardener on the statue in order to mold the silicon into the geometrical shape of ideal breast skin shape.

Final remaining area of breast surface skin hide behind the silicon model after surgery when we put the mentioned stencil on the breast before surgery we determined incision lines on the breast before surgery by marking around the stencil edges. The symmetric Stencil can put on the other breast and marking incision place if both of breasts need to surgery.

According to using same symmetric stencil for both breasts we can have two similar breasts with shape and size.

In addition, this invention provides a common software program for marking hypothetical incision lines on the software outputs obtained from the previous step, and by this software program, required lines can be marked on the hypothetical organs manually or in an intelligent manner. Using common or specialized software programs, the scanned body undergoes mesh generation or it is capable of being defined three- dimensionally (length, width, and height), by which the hypothetical incision lines are marked from the hypothetical reference point. Simulation software programs or specialized drawing software is employed to make required incisions on the body undergone mesh generation in software, and find the form of lines, length of incision lines, depth of incision, and hypothetical incision shape.

This invention is able to provide a 3-D image of the breast which is undergone surgery by a software program. The output of this step can be used for preparing isometric, diametric, or 2-D drawings from the different sides of the breast or a combination of the expanded surface of breast to prepare 2-D patterns on paper or plastic or any other flexible surfaces.

A calibrated video projector or non-harmful laser beam together as well as hardware which are correctly calibrated and installed can be used at the original scanning location for dropping reference and marking the body of the patient correctly to determine the final pattern of incision lines on the body. After deleting the displacement tolerance on patient’ s body in the scanner, and minimizing displacement error, the lines can be observed by optical or laser beams on the patient’s body and marked accordingly. Considering the capabilities of the 3-D printer, the existing shape of breast, the involved parts of the clavicle, under the breast, the involved side of the chest, and upper part of the breast can be printed in an integrated and meshed form. As the printed output is a template of the patient’s body before surgery, the surgeon can use the meshed template to find the final incision lines and put the meshed template on the patient’s body to mark the lines using the marker. During the mammaplasty surgery, this pattern can show the surgeon the shape and depth of incision. In addition, the final 3d model of the breast shape obtained after hypothetical surgery is used to print the special type of splint with required meshing and pores and a hole for the nipple and areola. To reduce the movement of breast or any additional pressure on the tissues of the breast supposed to undergo surgery, bandage splint or medical bra can be printed and used.

In case of using an analysis software, the final shape of the organ undergone surgery and incision lines can be determined to minimize the marking errors and use predefined protocols and customized lines based on the body of each patient by default. Thereafter, the patient is exposed to scanner for scanning without moving the case. At the same time, marking is carried out based on the instructions provided for determining incision lines by optical or laser beams and marker simultaneously.

BRIEF DESCRIPTION OF FIGURES:

Figure 1 : shows the Preoperative three-dimensional image of the patient breast Figure 2: shows the Postoperative three-dimensional image of the patient breast Figure 3 : shows the printed module of molded breast and chest after surgery Figure 4: shows the Silicon coating on the final breast maquette Figure 5 : shows the correctly incision position on the widely new breast

Figure 6: shows the application of the incision lines to the breast using prepared stencil

PURPOSES OF THE INVENTION:

The purpose of this invention is to create the breast marking stencil and method of produce and use of this stencil to determine the correct form of incision lines and also calculate the required reduction volume match to geometrical shape of incision lines in reduction mammoplasty surgery, optimize the results of surgery, and create the physical shape of breast after surgery for the patient and surgeon to decide correctly. DESCRIPTION OF AN ACTUAL CASE:

The first step of reduction mammoplasty by this method is positioning patient in front of scanner in standing position while she opens her arms to some extent from both sides in order to obtain a more accurate scan, It must be noted that we need to determine exact location of IMF in breast and we have to catch Two scans of patient. So, we scan breast in normal position at first and another scan start when have a good view of breast IMF. Then specialists insert this scans file into the graphical or design engineering software such as CATIA and/or other engineering software and merge scans together and create the exact 3D model of patient’s natural breast. After that, surgeon and experts of software make new design of the best model of patient’s breast that could be achieved after surgery. Patient can inform surgeon about her ideal breast shape during apply changes in 3D design. According to final model of designed breast and determine the volume of natural breast we can calculate how much tissue must be reduced from each breast.

Regarding to the ideal designed breast shape a statue of ideal breast shape will be produced by 3D printer.

So the surgeon and the patient after seeing the statue could have a better understanding about operation result.

Considering that The long term results has differences with short term results of surgery and it depends on the thickness and elasticity of patient’s skin, predictions about differences between short term and long term results considered in designing of ideal breast form. For example, during the design of patients with high rate of skin elongation the nipple area will be designed in upper position because we know after 6 months of surgery the patients breast drop off and nipple position will place in normal position.

The incision marking stencil is made by pouring mix of silicon and hardener on the final 3D printed of the desired shape and size of the breast as the expected outcome. The molded silicon then is cut according to the surgical technique intended to be used by the surgeon (e.g.; Inverted T method). Then we before surgery we can put the stencil on the patient’s breast and marking the breast according to the stencil. Surgeon knows that if the breast will be marked with mentioned stencil and reduction volume of each breast be equal with calculated required reduction volume, the final result of surgery will be same as pre designed shape.

Claims

CLAIMS:

1) The invention is a marking stencil design method for correct marking of incision lines used in reduction mammoplasty. It contains at least a 3-D scanner, a software system capable to change the 3-D file, a 3-D printer, and a 3-D print of ideal pre-designed breast shape and also using polymer material to produce stencil and using mentioned stencil as a tool to determine the skin area that should be remains and marking the breast before surgery and also this marking is based on the calculated reduction volume of each breast considering the volume of pre-designed ideal breast.

2) The Invention of claim 1 that comprise a 3-D flexible silicon stencil that helps the surgeon to mark the incision lines and size and correct skin removal area in reduction mammoplasty surgery;

3) The Invention of claim 1 that, the scanner can be optical, ultrasound, laser, or any other type of fixed or rotating 3-D scanner;

4) The Invention of claiml that, the file obtained from scanning can be used directly or after modification in the design software; 5) The Invention of claim 1 that, the software used for designing final model of breast shape can use any programming language or any other programming method;

6) The Invention of claim 1 that , the changes in the original scanned file in software environment can be performed manually by the operator or intelligently by the software;

7) The Invention of claim 1 that, the results of the designing by the software can be printed two- dimensionally or three-dimensionally to create the intended shape.

8) The Invention of claim 1 that, it can make a flexible coating on the prototype structure of the breast by silicon materials.

9) The Invention of claim 1 that, this method can minimize surgeon mistakes in reduction mammoplasty surgery. 10) The Invention of claim 1 that, in this method, the patient and surgeon can observe the results before surgery and in case of necessity, modify the procedure of surgery.

11) The Invention of claim 2 that, the stencil can be made of any material such as polymer, gelatin, silicon and/ or any other flexible material. 12) The Invention of claim 2 that, the stencil can be used for marking of the patient’s body for marking incision lines in reduction mammoplasty.

13) The Invention of claim 2 that, the stencil can be used as a comparison tool during mammoplasty by the surgeon. 14) The Invention of claim 1 that, in this method can calculate required volume to extract from each breast according to necessary changes and use from this calculation for removing excess breast tissue during surgery.

15) The Invention of claim 1 that, in this method, created final incision lines on each breast is matching to calculated volume to remove breast tissue. 16) The Invention of claim 1 that, the stencil produces based on the design of after surgery.