WO2024043587A1

WO2024043587A1 - Customized surgical guide and customized surgical guide generating method and generating program

Info

Publication number: WO2024043587A1
Application number: PCT/KR2023/011838
Authority: WO
Inventors: Beom Seok Ko; Nam Kug Kim; Guk Bae Kim; Sang Wook Lee; Sei Hyun AHN; Byung Ho Son; Jong Won Lee
Original assignee: Anymedi Inc.; The Asan Foundation; University Of Ulsan Foundation For Industry Cooperation
Priority date: 2022-08-26
Filing date: 2023-08-10
Publication date: 2024-02-29

Abstract

A customized surgical guide which can improve the convenience of surgery by accurately marking the surgical portion, includes a body portion cover having a shape corresponding to a surface of a body portion including a treatment portion; a marking guide portion formed on the body portion cover and including a marking hole through which a first medical instrument passes, and the treatment portion is positioned inside thereof; an alignment reference portion formed at a position corresponding to a main reference point on a body portion on which the body portion cover is located; and an alignment guide portion indicating a positional relationship between the main reference point and a sub reference point located on a different body portion other than the body portion, and the marking guide portion is configured to set a surgical region on the surface of the body portion including the treatment portion.

Description

CUSTOMIZED SURGICAL GUIDE AND CUSTOMIZED SURGICAL GUIDE GENERATING METHOD AND GENERATING PROGRAM

Embodiments described herein relate to a customized surgical guide, and a customized surgical guide producing method, and a producing program, and more particularly, to a customized surgical guide, a customized surgical guide producing method, and a producing program by which surgery is performed in accordance with a state of a treatment target region of a specific patient during the specific patient's surgery.

In surgery, medical staffs measure a region to be subjected to surgery based on medical images. In this process, the region measurement is dependent on the surgeon's eye-based measurement and experience. Thus, it may happen that a region to be removed is not completely removed. Further, a region to be removed is not accurately measured such that a large region than the region to be removed is cut off.

Further, a removal area on a skin surface is marked before surgery is performed. However, when the surgery starts and the body portion is excised, a marker on the surface of the skin may not match an inner portion to be removed, such that an accuracy at which the scope of surgery within the body portion is determined is lowered. In order to mark a certain point inside the body, an ultrasonic or mammography guide H-wire is inserted to remove a corresponding body portion. This may have marking inaccuracy. Further, this takes pain and long surgery time. Occasionally, a part of the H-wire is cut off or left in the body during surgery.

Some embodiments relate to a customized surgical guide, and a customized surgical guide producing method, and a producing program by which a removal region in a body portion subjected to surgery is three-dimensionally displayed, and, thus, accurate visual identification of the removal region (i.e., treatment target region) is realized during the surgery of the removal region.

Some embodiments relate to a customized surgical guide produced based on a treatment plan that allows a medical instrument to reach a plurality of target points within a body portion for treatment of the treatment target region at a minimal treatment procedure, and a customized surgical guide producing method, and a producing program.

The purposes to be achieved by Some embodiments of the present disclosure are not limited to the purposes mentioned above, and other purposes not mentioned may be clearly understood by those skilled in the art from the following descriptions.

The present disclosure is directed to a customized surgical guide, including a body portion cover having a shape corresponding to a surface of a body portion in which a treatment region is located; a marking guide portion formed on the body portion cover and including a marking hole through which a first medical instrument passes, and the treatment region is positioned inside thereof; an alignment reference portion formed at a position corresponding to a main reference point on a body portion on which the body portion cover is located; and an alignment guide portion indicating a positional relationship between the main reference point and a sub reference point located on a different body portion other than the body portion, and the marking guide portion is configured to set a surgical region on the surface of the body portion including the treatment region.

The body portion is a breast, and the alignment reference portion is a hole through which a nipple of the breast passes, which is the main reference point, and the alignment guide portion may include a straight member extending from the hole.

The alignment guide portion may include a first alignment guide portion toward a nipple of a breast, which is the sub reference point, other than the body portion.

The alignment guide portion may include a second alignment guide portion toward a jugular notch point, which is a sub reference point.

The body portion cover may be a mesh shape including a plurality of holes, and the alignment guide portion may be a solid bar shape in which no holes are formed.

The body portion cover may have a honeycomb structure including a plurality of hexagonal holes.

The marking guide portion may include a plurality of marking holes formed along the periphery of the surgical region.

The marking hole may have a width equal to or greater than the width of a first medical instrument, and a length greater than the width, and extend along the periphery of the surgical region.

A guide tube into which a second medical instrument is inserted may be included, and the guide tube may be formed along the marking guide portion.

The marking guide portion may include a plurality of marking holes formed along the periphery of the surgical region, and the guide tube may be positioned between the adjacent marking holes.

The second medical instrument may include a first portion smaller than a guide tube diameter and a second portion greater than the guide tube diameter, and the length of the guide tube may correspond to the difference between the length of the first portion of the second medical instrument and the distance from the surface of the body portion to a target point.

The body portion cover may be a mesh shape including a plurality of holes, and an inner side of the marking guide portion may be a solid shape in which no holes are formed.

According to another aspect of the present disclosure, a method of manufacturing a customized surgical guide including, obtaining body portion surface data and treatment region data from medical image data; generating first shape data of a body portion cover corresponding to the body portion surface data; calculating a safety boundary range including the treatment region, and generating second shape data of a marking guide portion corresponding to the safety boundary range; and modeling the body portion cover on which the marking guide portion is formed by merging the first shape data and the second shape data.

The safety boundary range may be spaced apart from the treatment portion by a predetermined distance.

The method may further include generating third shape data of an alignment reference portion at a position corresponding to a main reference point on the body portion, and the modeling of the body portion cover may include merging the first shape data to the third shape data and modeling the body portion cover including the alignment reference portion.

The method may include generating fourth shape data of an alignment guide portion connecting between a sub reference point located on a different body portion other than the body portion and the main reference point, and the modeling of the body portion cover may include merging the first shape data to the fourth shape data and modeling the body portion cover including the alignment guide portion.

The body portion may be a breast, and the third shape data may have a hole shape through which a nipple of the breast, which is the main reference point, passes, and the fourth shape data may be a linear shape extending from the third shape data toward at least one of a nipple point of a breast or a jugular notch point other than the body portion, which is the sub reference.

The second shape data may include a plurality of marking holes formed on the body portion cover along the safety boundary range, and further include an operation of generating a fifth shape data of a guide tube into which a second medical instrument positioned between the plurality of marking holes is inserted, and the modeling of the body portion cover may model the body portion cover including the guide tube by merging the fifth shape data.

When the body portion surface data is obtained from a second posture different from a first posture during surgery, operations of converting it into the first posture and calculating the body portion surface data and the treatment region may be included.

According to another aspect of the present disclosure, a customized surgical guide generating program, combined with a computer that is a hardware, and stored in a medium to execute the above method is provided.

According to the present disclosure, following various effects may be realized.

First, using the customized surgical guide that assists in performing patient-customized surgery may allow optimal surgery for the patient. For example, when a to-be-removed lesion (for example, tumor) within the affected portion should be removed, the patient-customized surgical guide is used to produce at least one dye column in the body portion. The dye column may be used to allow the medical staff to visually check the to-be-removed region during surgery. Thus, the medical staff may remove a minimal tissue via two-or three-dimensional marking using the dye column.

Second, it is possible to align the surgical guide in the correct position based on the reference point of the body part, so that the accurate surgical area may be displayed. Even when the sub reference point is located on the outside of the surgical guide, the position may be aligned through the alignment guide, so that a sufficiently accurate surgical area can be displayed even with a small size surgical guide.

Third, it is possible for an operator to secure a clear view by forming a body part cover only in a necessary area. In addition, the manufacturing cost can be reduced, so that the unit cost can be lowered and the manufacturing time can be shortened.

Fourth, since the guide tube is produced by calculating a depth to the target point based on the medical image data, the medical staff may perform the surgery without paying attention to the depth of insertion of the medical instrument, (for example, syringe). In other words, when the medical instrument is fully inserted into the guide tube of the customized surgery guide, the medical instrument reaches the target point, so that the surgery can be easily performed.

Fifth, the body portion cover is shaped to conform to the body portion shape, and the body portion cover defines a position of the guide tube such that the medical instrument accurately reaches the target point within the body portion. This prevents treatment from being performed on a wrong target point or prevents erroneously marking in the body portion.

The above and other objects and features will become apparent from the following description with reference to the following figures, wherein like reference numerals refer to like parts throughout the various figures unless otherwise specified, and wherein:

FIG. 1 is a perspective view of a customized surgical guide according to some embodiments.

FIG. 2 is an illustration of a customized surgical guide attached to a body portion according to some embodiments.

FIG. 3 is an illustration of forming a dye column from a target point of a treatment target region surface through a guide tube according to some embodiments.

FIG. 4 is a flowchart of a customized surgical guide producing method according to some embodiments.

FIG. 5 is a flowchart of a customized surgical guide producing method further including calculating a position change of a treatment target region in a second posture using first posture-based medical image data, according to some embodiments.

FIG. 6 is a flowchart of a customized surgical guide producing method further including requesting injection based on last shape data according to some embodiments.

FIG. 7 is a flowchart illustrating a process of producing a body portion cover shape covering an entire body portion according to some embodiments.

FIGS. 8A to 8C are views illustrating a surgical guide according to another embodiments.

FIGS. 9A and 9B are views illustrating a surgical guide according to still another embodiments.

FIGS. 10A and 10B are views illustrating a safety boundary range for setting a marking guide part of a surgical guide according to another embodiments.

FIGS. 11A to 11C are views illustrating modeling processes for designing a surgical guide according to another embodiments.

FIGS. 12A to 12D are views illustrating a method used in breast cancer surgery using the surgical guide of the inventive concept.

FIGS. 13 to 16 are flowcharts illustrating a surgical guide generation method of the inventive concept.

Hereinafter, preferred embodiments of the inventive concept will be described in detail with reference to the accompanying drawings. Advantages and features of the inventive concept, and methods of accomplishing the same, will become apparent with reference to the embodiments described in detail below with reference to the accompanying drawings. However, the inventive concept is not limited to the embodiments disclosed below, but may be embodied in various forms. These embodiments are provided so that the disclosure of the inventive concept is complete and that it is believed that the disclosure is intended to be completely understood by those skilled in the art to which the inventive concept belongs. The inventive concept is only defined by the scope of the claim. Like reference numerals refer to like elements throughout the specification.

Unless otherwise defined, all terms including technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this inventive concept belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present disclosure. As used herein, the singular forms "a" and "an" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises", "comprising", "includes", and "including" when used in this specification, specify the presence of the stated features, integers, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, operations, elements, components, and/or portions thereof.

As used herein, a term "computer" includes all of various devices that can perform computational processing and present the results visually to the user. For example, the computer may include a desktop PC, a notebook, a smartphone, a tablet PC, a cellular phone, a PCS phone (Personal Communication Service phone), synchronous/asynchronous IMT-2000 (International Mobile Telecommunication-2000) mobile terminal, a palm personal computer, personal digital assistant (PDA), and so on. Further, a computer may be a medical device that acquires or observes an angiographic image.

As used herein, a term "medical image data" means image data obtained by medical imaging devices such as Computed Tomography (CT) device, MRI (Magnetic Resonance Imaging) device or the like.

As used herein, a term "treatment target region" refers to a region to be treated within a specific body portion. For example, in patients with breast cancer, the treatment target region corresponds to a tumor region in the breast as the body portion. The treatment target region may coincide with an affected region or may be actually larger than the affected region with considering an error range.

As used herein, a term "medical instrument" refers to a tool which is used for surgery, treatment, or examination, and is inserted or invaded into the body. For example, the medical instrument may be a syringe with a needle of a specific length. Further, for example, the medical instrument may be a device that is inserted into a specific body portion and applies electrical stimulation to a specific range.

As used herein, a term "target point" refers to a point reached by the medical instrument inserted through a customized surgical guide. In other words, the target point means a point of maximum depth reached by the medical instrument while movement of the medical instrument is limited by the guide tube. The target point may be a point located on the surface of or interior in the treatment target region, or a point separated by a certain distance from the treatment target region.

As used herein, a term "first point" refers to a point on the body portion surface from which the medical instrument is inserted to reach the target point. That is, the first point refers to the point on the body portion surface where the guide tube is placed when placing a customized surgical guide in the body portion.

Hereinafter, a customized surgical guide, a customized surgical guide producing method and a producing program according to embodiments of the inventive concept will be described in detail.

FIG. 1 is an illustration of a customized surgical guide 10 according to one embodiment of the inventive concept.

Referring to FIG. 1, the customized surgical guide 10 according to one embodiment of the inventive concept includes a guide tube 100 and a body portion cover 200.

The guide tube 100 refers to a tube into which a medical instrument can be inserted. The guide tube 100 has a larger diameter than that of a portion of the medical instrument that is inserted into the body. Since the portion of the medical instrument is inserted into the body, it may be dangerous when the portion of the medical instrument contacts a wall surface of the guide tube 100 and thus foreign matter is attached to the portion of the medical instrument. Therefore, the guide tube 100 has a larger diameter than that of the portion of the medical instrument such that the portion of the medical instrument is not in contact with the wall surface of the guide tube 100. For example, when the medical instrument is a syringe with a needle, the guide tube 100 has a larger diameter than that of the needle, and supports the syringe body and is oriented to an orientation of the syringe body such that the needle is inserted at an accurate angle. The guide tube 100 is formed with a length that limits a depth at which the medical instrument can be inserted into the body to a set depth from the first point to a target point 40. For example, when the medical instrument is a syringe with a needle, the guide tube 100 is formed such that the needle is inserted into the guide tube 100 and then the syringe is stopped by the guide tube 100 so that the needle enters the body only at a certain depth. For example, when the length of the needle is A, and the length of the guide tube 100 is B, the needle enters the body only as long as a length corresponding to "A - B" as the syringe is stopped by the guide tube 100. Thus, the guide tube 100 of the customized surgical guide 10 limits the depth at which the medical instrument is inserted into the body.

The length of the guide tube 100 is set based on a distance from the first point on the body surface to the target point 40 which the medical instrument should reach, on the medical image data. In one embodiment, when the customized surgical guide 10 is injected by a 3D printer, the computer analyzes a CT image or MRI image to calculate the distance from the specific first point on the surface of the body portion to the specific target point 40. Thereafter, the length of the guide tube 100 is calculated by subtracting the calculated distance from the length (for example, the length of the syringe needle) of the medical instrument used during the surgery. This allows the computer to set the length of the guide tube 100 of the customized surgical guide 10 based on the patient's treatment target region 20.

The customized surgical guide 10 according to one embodiment of the inventive concept has a number of guide tubes 100 corresponding to the number of target points 40 in the body. Since each guide tube 100 is produced to have a length and direction to reach from the first point to the target point 40, the number of the guide tubes 100 as produced may correspond to the number of the target points 40.

The body portion cover 200 is coupled to at least one guide tube 100, as in FIG. 1. That is, the body portion cover 200 has a hole defined therein through which the medical instrument inserted through the guide tube 100 passes toward the body portion. In this way, the medical instrument inserted through the guide tube 100 is invaded or inserted into the body portion along an extension of the guide tube 100.

The body portion cover 200 covers a surface of a specific body portion. Specifically, the body portion cover 200 is formed to conform to the surface of the body portion of the patient. In one embodiment, the body portion cover 200 is produced based on body surface data obtained based on the medical image data. For example, when the body portion cover 200 is injected using a 3D printer and the breast of a breast cancer patient is set as a body portion, shape data of the body portion cover 200 conforming to a surface of the patient's breast shape in capturing the MRI image or CT image is produced based on the MRI image or the CT image. Thus, the body portion cover 200 conforms to the body portion surface. Thus, when the medical instrument is inserted into the guide tube 100 of the customized surgical guide 10 produced based on the medical image data, the medical instrument reaches the target point 40 in the body portion accurately. That is, the body portion cover 200 allows the guide tube 100 to be positioned at the first point set in a treatment planning process based on the medical image data.

Further, in another embodiment, the customized surgical guide 10 includes a reference point 300 for precise positioning of the customized surgical guide 10 when applied to the patient, as shown in FIG. 2. The reference point 300 corresponds to a specific location of the body portion to allow the customized surgical guide 10 to be placed at the exact location set in the surgery planning or modeling. For example, when the body portion is a breast, the customized surgical guide 10 has a hole with the same size as a nipple at a point corresponding to the nipple. Thus, the accurate attachment position is set on the body portion surface while the nipple is set as the reference point 300.

In yet another embodiment, when a body portion including the treatment target region 20 has a shape changing depending on a posture of the patient, the body portion cover 200 of the customized surgical guide 10 covers the body portion and fixes the body portion into a specific shape. For example, when the body portion is the breast, a shape of the breast may change depending on a posture of the patient. Therefore, when the breast has the same shape at the breast shape in setting the target point 40 based on the medical image data, the medical instrument can reach the target point 40 through the customized surgical guide 10 accurately. Accordingly, the body portion cover 200 may be formed to cover the entire body portion, and thus to deform and retain the body portion into and as a shape obtained at imaging of the medical image data. For example, when the body portion is a breast, the body portion cover 200 may be made in the same shape as a brassiere, and may be worn on the patient during breast cancer surgery.

The customized surgical guide 10 according to one embodiment of the inventive concept may be implemented in various forms according to use purposes and may be used in various ways. In one embodiment, when the medical instrument is a syringe with a specific needle length, the guide tube 100 is formed such that the syringe needle reaches the target point 40. In this connection, the target point 40 is the specific point on the surface of the treatment target region 20 in the body portion. That is, the customized surgical guide 10 is formed such that the specific point on a surface of the treatment target region 20 (the specific point on an interface between the treatment target region 20 and a normal region) is the target point 40. The plurality of target points 40 may be indicated as points on a plane corresponding to the interface between the treatment target region 20 and normal region or may be indicated as a plurality of points on the three-dimensional space of the treatment target region 20 having a three-dimensional shape.

Specifically, as shown in FIG. 3, a syringe filled with a dye is inserted through the customized surgical guide 10 to a distal end thereof to reach the target point 40. While the syringe is removed out of the guide, the dye is slightly discharged from the syringe to dye an inside of the body portion. Thus, a dye column 30 is formed to extend from the target point 40 in the body portion to the first point of the body portion surface.　

Forming a plurality of dye columns 30 through each guide tube 100 of the customized surgical guide 10 may allow an accurate to-be-removed region (that is, treatment target region 20) to be grasped. Even when the medical team cuts away the affected portion, the dye column 30 is continuously present from the target point 40. Thus, the point corresponding to the boundary of the treatment target region 20 may be confirmed in the surgical procedure.

Further, in another embodiment, when the medical instrument is of a tool for performing treatment while setting, as a treatment range, a specific range from a specific point which the medical instrument reaches, the target point 40 is at least one specific point located within the treatment target region 20 to form at least one treatment range that encompasses the treatment target region 20. That is, the target point 40 reached by the medical instrument through the guide tube 100 becomes a specific point within the treatment target region 20, while the medical instrument treats the treatment range centered on the target point 40 by providing electricity thereto. 　

In this connection, the number of the guide tubes 100 corresponds to the number of the target points 40. Each of the number of the guide tubes 100 is formed on the first point of the body portion cover 200 and extends in a direction from the first point toward the target point 40. When the treatment target region 20 is larger than the treatment range, the customized surgical guide 10 includes a specific number of guide tubes 100 such that treatment ranges formed around target points 40 of the guide tubes 100 respectively may overlap to cover the treatment target region 20. Thus, the surgeon can perform the surgery simply by inserting the medical instrument(s) into the guide tubes 100 which respectively guide the medical instrument to the target points 40 set according to the patient surgery plan.

Further, in another embodiment, the customized surgical guide 10 is formed of a deformable material, and is inserted using a laparoscope into the body, and then placed on the body portion surface. The customized surgical guide 10 may be placed on an internal organ surface that is not exposed to the outside. To this end, the customized surgical guide 10 is made of a material that can be deformed in shape and is inserted to a specific body portion inside the body using the laparoscope while the guide is folded or wound.

Further, in another embodiment, the guide tube 100 may be fitted with the medical instrument when a distal end of the medical instrument reaches the target point 40. This allows the medical staff to recognize that the medical instrument has reached the target point 40. For example, a body of the guide tube 100 may be formed with a first diameter that allows only the needle to enter thereto, while the distal end of the guide tube 100 has a second diameter that conforms to the syringe tip. As the syringe tip is fitted in the second diameter portion of the guide tube 100 and no longer enters the body of the guide tube 100 having the first diameter. Thus, the medical staff may recognize that the target point 40 has been reached by the medical instrument. Further, when a medical instrument must apply stimulation, for example, electrical stimulation to the target point 40 for a duration longer than or equal to a specific time, the fitting between the guide tube 100 and the medical instrument maintains a state in which the medical instrument reaches the target point 40 and is fixed thereto.

FIG. 4 is a flowchart of a producing method of a customized surgical guide 10 according to one embodiment of the inventive concept.

Referring to FIG. 4, a producing method of a customized surgical guide 10 according to one embodiment of the inventive concept may include operation S100 in which a computer acquires body surface data and treatment region data from medical image data; first shape data generating operation S300 in which the first shape data is generated based on the body surface data by the computer, wherein the first shape data is data corresponding to a shape of the body portion cover 200; target point setting operation S500 in which at least one target point 40 is set by the computer, wherein the target point 40 is a point corresponding to the interior or surface of the treatment target region 20; operation S700 in which each first point on the body surface is set by the computer, wherein the medical instrument is accessible from the first point to the target point 40; operation S900 in which a length of the guide tube 100 is set by the computer based on a distance from the first point to the target point 40; and operation S1100 in which last shape data is generated by the computer by applying the length of the guide tube 100 to the first point, wherein the last shape data include a combination of shape data of at least one guide tube 100 and the first shape data. Hereinafter, a detailed description of each operation will be described.

The computer acquires body surface data and treatment region data from medical image data (S100). That is, the computer obtains the medical image data of the specific patient (for example, the MR image of the patient), and obtains, from the medical image data, the body surface data for forming the body portion cover 200 and the treatment region data corresponding to the treatment target region 20. Specifically, when the treatment target region 20 is a tumor, the computer extracts the tumor region from the medical image data.

The computer produces the first shape data based on the body surface data (S300: first shape data generating operation). The first shape data is data corresponding to the shape of the body portion cover 200. That is, the computer performs 3D modeling into the shape corresponding to the patient's affected surface. Thus, the customized surgical guide 10 having the body portion cover 200 that fits in the body portion of the patient may be manufactured.

Further, the computer sets, as the reference point 300, a point on the first shape data corresponding to a specific point on the body surface data. For example, when the body part to be treated (that is, the affected portion) is the breast, the computer forms a nipple hole 300 based on the nipple position on the body surface data. Thus, the computer may use the nipple hole 300 as a reference when positioning the customized surgical guide 10 on the body portion surface.

Further, in another embodiment, as in FIG. 7, the first shape data generating operation S300 includes operation S310 for obtaining the entire shape data of the body portion; and operation S320 for producing a shape of the body portion cover 200 covering the specific body portion based on the entire shape data. When the body portion has a shape changing according to the posture of the patient, for example, the body portion is a breast, the body portion cover should be formed to cover the entire body portion, and thus to deform and retain the body portion into and as a shape obtained at imaging of the medical image data, thereby to perform precise surgery using the customized surgical guide 10 as produced based on the medical image data. Thus, the computer acquires the entire shape of the body portion from the medical image data, and then models the body portion cover 200 into a shape covering the entire body portion.

For example, an MR imaging of the breast of a breast cancer patient is performed while the patient lies down at a state in which her face faces downwardly, whereas a breast cancer tumor removal surgery is performed while the patient lies down at a state in which her face faces upwardly. Because the shape of the breast changes due to the difference between the posture in the MR image and the posture in the surgery, the tumor position inside the breast may change. Thus, to accurately mark the tumor region inside the body via dying, the breast shape should be fixed and maintained to and as the breast shape obtained at the imaging of the medical image data during surgery. Therefore, the computer models the cover into the shape covering the entire breast, and produces the cover via injection. Then, the body portion cover 200 is placed on the breast and fixes and maintains the breast shape into that obtained at the imaging of the medical image data during surgery.

According to still another embodiments, a breast cancer tumor removal surgery of breast cancer patients may be performed in a supine position (a first position), and MRI imaging of the breast may also be performed in the supine position. Since the shape of the breast may be changed due to minute differences in posture during MRI imaging and surgery, the location of the tumor inside the breast also changes. In order to accurately mark the tumor area inside the body through dyeing, it must be fixed and maintained in the shape of the breast when the medical image data is taken even during surgery. Therefore, the computer models the entire breast in a shape that covers the entire breast, and when it is injected and used for surgery, the breast is disposed in the body part cover 200 to maintain the breast shape when taking an MRI image.

The computer sets at least one target point 40 (S500: target point setting operation). The target point 40 is the point corresponding to the interior or surface of the treatment target region 20. Specifically, the computer models the treatment target region 20 (that is, the to-be-removed region) based on the calculated target region (for example, the tumor region) with considering the error range. The computer then extracts at least one point in and on the treatment target region 2 as the target point 40.

In one embodiment, when the medical instrument is a syringe with a specific needle length, the target point 40 is set to the specific point on the surface of the treatment target region 20. That is, the target point 40 is the point on a boundary face defining a tissue to be removed via surgical surgery (that is, the tumor tissue).

Further, in another embodiment, when the medical instrument is a tool that performs treatment while a treatment range is set to a specific range around a point of a specific depth which the medical instrument reaches, the target point 40 is a specific point within the treatment target region 20. In the target point setting operation S500, the computer sets at least one target point 40 to define at least one treatment region covering the treatment target region 20. That is, the computer extracts a plurality of a specific medical instrument-based treatment ranges capable of covering the treatment target region 20 and extract multiple target points 40 defining the treatment ranges respectively which the medical instrument should reach.

The computer sets each first point on the body surface, wherein the medical instrument is accessible from the first point to the target point 40 (S700: first point set operation). For example, when the treatment target region 20 is a tumor region, the computer determines the position (that is, the three-dimensional position) on the body portion surface from which the needle may be injected toward a boundary of the tumor region.

Further, when the target point 40 is set to a point in the boundary between the treatment target region 20 and the normal tissue region, the computer sets a first point from which the medical instrument reaches the target point 40 without passing through the treatment target region 20. For example, when the treatment target region 20 is a tumor region, and when a medical instrument (such as a syringe needle) is inserted from the skin surface through the tumor region to reach the target point 40, the tumor region is damaged, such that cancer cells may be transferred to other body portions. Thus, the computer extracts the first point from which the medical instrument reaches the target point 40 without penetrating the treatment target region 20. To this end, when the target point 40 is located deeply within the body in the treatment target region 20, the computer sets the first point from which the medical instrument is accessible to the target point 40 in a lateral direction.

Further, the computer sets an orientation angle of the guide tube 100 according to the position of the first point set in association with the target point 40. For example, when the medical instrument has a straight line shape, the guide tube 100 is oriented in a direction of an extension of a straight line connecting the target point 40 and the first point. Thus, when the medical staff merely inserts the medical instrument into the guide tube 100, the medical instrument may reach the target point 40.

The computer sets the length of the guide tube 100 based on the distance from the first point to the target point 40 (S900: guide tube 100 length setting operation). The computer forms the guide tube 100 having a length such that a depth at which the medical instrument can be inserted into the body is limited to a set depth from the first point to the target point 40. For example, when the medical instrument is a syringe with a needle, the guide tube 100 is formed such that the needle is inserted into the guide tube 100 sand then the syringe is stopped by the guide tube 100 so that the needle can only enter the body by the specific depth. That is, when the length of the needle is A, and the length of the guide tube 100 is B, the needle enters the body only as long as the length corresponding to "A - B" as the syringe is stopped by the guide tube 100. Therefore, the computer sets the length of the guide tube 100 to a value calculated based on the length of the medical instrument and the distance between the target point 40 and the first point (that is, to the difference between the length of the medical instrument and the distance between the target point 40 and the first point).

The computer applies the length of the guide tube 100 to the first point to generate the last shape data as combination of shape data of at least one guide tube 100 with the first shape data (S1100: last shape data generating operation). That is, the computer generates the last shape data as the combination between the shape data of at least one guide tube 100 and the shape data of the body portion cover 200. The last shape data indicates that the guide tube 100 having a specific length and orientation is coupled to the body portion cover 200 at a specific position thereof. In other words, the computer adjusts and models the length of each of the columns of the guide tubes 100 so that the needle can reach the boundary of the tumor region accurately when the needle is inserted through each of the guide tubes.

The guide tube 100 of the customized surgical guide 10 as thus-formed performs various roles. In one embodiment, when the medical instrument is a syringe with a specific needle length, the guide tube 100 serves to assist in producing the dye column 30 in the body when the syringe supplies a dye into the body while the syringe is removed away from the target point after the syringe needle reaches the target point 40. Further, in another embodiment, the guide tube 100 plays a role in raising the accuracy of the surgery by allowing the medical instrument to reach precisely the target point 40 to be treated based on the surgery plan.

Further, in another embodiment, as shown in FIG. 5, when a first posture of the patient at which the medical image data is taken is different from a second posture of the patient at which surgery is performed, the method further includes operation S200 for calculating the positional change of the treatment target region 20 when the posture changes from the first posture to the second posture. When the medical image data is taken at a posture at which surgery is performed, the customized surgical guide 10 may be modelled based on the medical image data. However, there may be cases where a posture taken for imaging a medical image and a posture taken for surgery are different. In this case, in order to produce the customized surgical guide 10 corresponding to the second posture taken at the time of surgery, that is, in order to produce a customized surgical guide 10 that corresponds to the second posture for the surgery based on the medical image data taken at the first posture, the computer calculates the positional change of the treatment target region 20 when the posture of the body portion of the patient changes from the first posture to the second posture.

For example, among the body portions, the breast changes the shape thereof flexibly according to the posture of the patient. The MR image is taken at the first posture in which the patient lies down with her face facing downwardly, whereas the surgery is performed at the second posture in which the patient lies down with her face facing upwardly. Therefore, the breast shape may vary between the MR image capture and the surgery. As the breast shape changes, a position of the tumor tissue in the breast in the three-dimensional space may vary. Therefore, the computer identifies the breast shape in the second posture based on the size of the breast, and the breast shape in the first posture, and calculates the position of the tumor in the breast shape in the second posture (that is, calculates the position of the treatment target region 20).

Further, when a medical image is taken at the first posture and then the customized surgical guide 10 corresponding to the second posture is modeled, the target point setting operation S500, the first point setting operation S700, and the guide tube length setting operation S900 may be performed based on the changed position of the treatment target region 20.

In yet another embodiment, the first shape data generating operation S300 calculates the shape of the body portion in the second posture based on the medical image data obtained in the first posture, and models the shape data of the body portion cover 200 (that is, the first shape data) based on the calculated shape data.

Further, in another embodiment of the inventive concept, where the medical instrument is curved at a specific curvature, the computer produces the guide tube 100 at the same curvature as that of the medical instrument. A straight line shaped medical instrument may have difficulty in reaching the target point 40 in the body. In this case, the curved medical instrument may be used. In order to insert the curved medical instrument having a specific curvature through the customized surgical guide 10 into the body, the guide tube 100 must be made at the same curvature as that of the medical instrument and be smoothly inserted. Thus, on the medical plan, the medical instrument may reach the accurate target point 40.

Further, in order to model the guide tube 100 into which a bent curved medical instrument is inserted, the first point setting operation 700 extracts the first point from which the medical instrument reaches the target point 40 while moving inside the body along a curved path. That is, the computer extracts not a first point from which the medical instrument reaches the target point 40 when moving along a straight-line path, but a first point from which the medical instrument reaches the target point 40 when moving along a specific curvature-based path.

Further, the last shape data generating operation S1100 generates the curvature of the guide tube 100 equal to the curvature of the medical instrument. The last shape data generating operation S1100 calculate the curve length of the guide tube 100 by subtracting, from the medical instrument length, the distance by which the medical instrument should travel along the curved path in the body.

Further, as shown in FIG. 6, another embodiment of the inventive concept further includes operation S1200 for requesting injection of the surgical guide corresponding to the last shape data. That is, the computer requests injection of the guide corresponding to the modeled last shape data to a 3D injection device, that is, a 3D printer.

FIGS. 8A to 8C are views illustrating a surgical guide 900 according to another embodiments. FIG. 8A is a perspective view, FIG. 8B is a front view, and FIG. 8C is a side view.

FIGS. 9A and 9B are views illustrating the surgical guide 900 according to still another embodiments, and FIG. 9A is a front view and FIG. 9B is a side view.

The surgical guide 900 of the inventive concept serves as a guide for visually determining a surgical area including a lesion area 1001 of the breast before surgery, and may include a body portion cover 902, a marking guide portion 907, an alignment reference portion 901, and an alignment guide portion 906.

The body portion cover 902 is a member safely seated on the body portion in which a treatment portion 1003 is located and may have a shape corresponding to the surface shape of the body portion. Since the body part of the present disclosure is a breast, it may have a curved shape as shown in FIG. 8A. It is not necessary to cover the entire breast, which is the surgical portion, and may be partially located in a portion including the treatment portion 1003 in which the lesion has occurred.

The body portion cover 902 may be configured in the form of a mesh in which a plurality of holes are formed as shown in FIG. 8A. Through the hole in the mesh, an operator may secure a clear view, and it can be checked whether the body part cover 902 is in close contact with the body portion without lifting. Although the expression "mesh" is used, the size of the hole is not small and may have a size of 1~2cm or more.

In addition, due to the mesh-structured body portion cover 902, the weight of the product is reduced, the manufacturing time is shortened, and the material is saved, thereby reducing the unit price of the product.

The body part cover 902 according to the embodiments may be formed, for example, in a mesh structure to provide a hole through which a hook wire may pass through the body portion cover 902 so that the hook wire (not shown) for displaying a path to the target point or for displaying a to-be-removed portion is not pressed by the body portion cover 902.

A general mesh structure has many holes in itself, so a support rate may be low. The body portion cover 902 according to the embodiments may be formed in a honeycomb structure having a high support rate in which the shape of the product itself is well maintained.

The body portion cover 902 of the inventive concept includes the marking guide portion 907 for marking the surgical region to be surgically removed. The surgical region includes the treatment portion 1003, and the treatment portion 1003 is a region on the skin corresponding to a lesion area 1001. The lesion area 1001 may be removed by making an incision from the treatment portion 1003 toward the lesion area 1001. To prevent recurrence, the surgical region may be formed slightly larger than the treatment portion 1003.

The marking guide portion 907 may include a plurality of marking holes 9071 formed along the periphery of the surgical region. The marking hole 9071 may extend lengthwise along the boundary of the surgical region as shown in FIG. 8B.

The marking hole 9071 may have a partially broken shape 9072 so as not to be separated from the body portion cover 902, and an operator inserts a medical pen, which is a first medical instrument, into the marking hole 9071 and may mark the surgical region on the surface of the patient's body portion along the extension direction of the marking hole 9071.

The marking hole 9071 may have a width corresponding to the thickness of a nib of the medical pen and extend along the surgical region.

A guide tube 909 may be disposed between the plurality of marking holes 9071. The guide tube 909 is a means for marking the surgical region up to the inside of the body portion into which a second medical instrument 820 is inserted, and when the marking guide portion 907 functions to mark the surgical region on the surface, the guide tube 909 may indicate a three-dimensional boundary.

The second medical instrument 820 may be a syringe 820 for injecting a medical ink 823, and an inner width of the guide tube 909 may be greater than the diameter of a needle 821 of the syringe 820 and smaller than the diameter of the main body of the syringe 820.

However, when an operator does not use the second medical instrument 820, the guide tube 909 may be omitted and the surgical guide 900 in which the guide tube 909 is omitted as shown in FIGS. 9A and 9B may be manufactured.

An inside of the marking guide part 907 may have a solid shape. Since the body portion cover 902 has a mesh shape, it may have a partially hole-free solid form for overall rigidity. In particular, since the guide tube 909 protrudes three-dimensionally from the body portion cover 902, rigidity is required to maintain an angle at which the guide tube 909 protrudes from the body portion cover 902, so the inside of the marking guide portion 907 may be configured to be solid.

FIGS. 10A and 10B are views illustrating a safety boundary range 1008 for setting a marking guide portion 907 of a surgical guide 900 according to another embodiments.

As shown in FIG. 10A, the lesion region 1001 is located inside the skin, and the portion extending vertically from the lesion region 1001 on the skin at the position closest to the lesion region is the treatment portion 1003.

However, when only the treatment portion 1003 in which the lesion region 1001 is located is removed by surgery, there is a risk of recurrence when the lesion cells 1001 have spread to surrounding tissues.

Therefore, the safety boundary range 1008 may be calculated to be slightly larger than the treatment portion 1003 and the surgical region may be determined. The safety boundary range 1008 may be set to be about 3mm to 10mm (in the embodiment of FIG. 10B, 5mm) larger than the treatment portion 1003, which is the region on the skin in which the lesion region 1001 is located on the inside.

At this time, the difference between the treatment portion 1003 and the safety boundary range 1008 may vary depending on the size and depth of the lesion region 1001.

As shown in FIG. 10B, the safety boundary range 1008 may be set as the surgical region, and the marking guide portion 907 may be designed along the outline of the safety boundary range 1008. According to the embodiments, in the case of injecting a medical dye through the guide tube 909 described above, a distance of about 5mm from the outermost line of the treatment target region may be spaced and marked so that the range may be further removed. When the ink 823 is spread, the ink may be spread by about 5mm on both sides of the marking line. Therefore, the thickness of the marking line may be 10mm. In consideration of this, it may be marked along the outline spaced outward by at least 5mm or more from the treatment target region, but in consideration of the spreading of this marking line, the body portion may be removed by surgery along the outside of the center line of the marking line.

As shown in FIG. 10B, the safety boundary range 1008 may be set as the surgical region, and the marking guide portion 907 may be designed along the outline of the safety boundary range 1008. In the case of injecting the medical dye through the guide tube 909 described above, when the ink 823 spreads, an ink column with a thickness of about 3 to 5 mm is formed, and in consideration of the thickness of the medical pen, the central portion of the marking guide portion 907 and the guide tube 909 may be designed to be located slightly inside by 2 to 3mm from the safety boundary range 1008.

When the surgical guide 900 is placed in an accurate position on the patient's body portion, the surgical region may be accurately marked. Therefore, the surgical guide 900 may set a reference point by determining a specific point of the body as a reference.

FIGS. 11A to 11C are views illustrating modeling processes for designing a surgical guide 900 according to another embodiments.

A method of designing the alignment reference portion 901 and the alignment guide portion 906 for seating the surgical guide 900 on a body portion based on a main reference point 801 and

sub reference point

802 and 803 is shown.

Although the reference point may be different depending on the surgical region, this embodiment will be described based on the surgical guide 900 for removing the lesion point generated in the breast. As the reference point, a nipple of a breast in which a surgical region in which a lesion has generated is located may be used as the primary main reference point 801.

Since the main reference point 801 is located on the surgical guide 900, the alignment reference portion 901 may be formed on the body portion cover 902. The alignment reference portion 901 may have a hole shape into which the nipple may be inserted, which is the main reference point 801. The body portion cover 902 covers the surgical region including the nipple, and as shown in FIG. 11A, the surgical region may be located just below the nipple, and as shown in FIGS. 11B and 11C, even when the surgical region is located at a position spaced apart from the nipple, the body portion cover 902 may extend to the nipple position.

However, since the nipple is one point, a plurality of reference points are required to set an accurate surgical region, and

sub reference points

802 and 803 may be further set in addition to the main reference point 801. In breast surgery, as the

sub reference points

802 and 803, the nipple point of a breast on the other side other than a breast in which the surgical region is located may be used as a first sub reference point 802 and a jugular notch point may be used as a second sub reference point 803.

The

sub reference points

802 and 803 are spaced apart from the breast, which is the surgical region, so it is difficult to directly display the positions of the

sub reference points

802 and 803 on the body portion cover. Instead, as shown in FIG. 11A, the alignment guide portion 906 corresponding to

extension lines

807 and 808 extending from the main reference point 801 toward the

sub reference points

802 and 803 may be formed.

As shown in FIG. 11A, the alignment guide portion 906 may include a bar-shaped member elongated on the body portion cover 902, and when the body portion cover 902 is made of a solid material, the alignment guide portion 906 may be configured in the form of a slit formed along the

extension lines

807 and 808.

Since the present embodiment is a mesh type body portion cover 902 having a honeycomb structure, a bar-shaped alignment guide portion 906 crossing the mesh may be included. The first alignment guide portion 9061, in which the first sub reference point 802 faces the other nipple, forms a horizontal direction when the body portion cover 902 is seated on the body portion, and the second alignment guide portion 9062 facing the jugular notch point, which is the second sub reference point 803, may extend obliquely upward from the first alignment guide at a predetermined angle.

After an operator inserts the alignment reference portion 901 into the nipple of the surgical region, the alignment guide portion 906 may extend toward the

sub reference points

802 and 803.

The body portion cover 902 does not need to cover the entire breast, but may have a size sufficient to identify the position of the marking guide portion 907, the alignment reference portion 901, and the alignment guide portion 906 corresponding to the surgical region.

FIGS. 12A to 12D are views illustrating a method used in breast cancer surgery using the surgical guide 900 of the inventive concept.

Referring to FIG. 12A, a nipple of a breast is inserted into the alignment reference portion 901 and the body portion cover 902 may be seated on the breast. Thereafter, the first alignment guide portion 9061 is disposed toward the nipple on the other side, and the body portion cover 902 is rotated to be disposed toward the jugular notch point and disposed on the breast. Thereafter, a marking line 1007 may be displayed on the body portion along the marking guide portion 907 using a medical pen. In addition to the marking line 1007 on the skin, the inside of the skin may be dyed through the human body ink 823 to display the surgical region in three dimensions.

FIG. 12B illustrates a method of dyeing by injecting a dye through the guide tube 909. As shown in FIG. 12B, after inserting the needle 821 of the syringe 820 into which the ink 823 is injected into the guide tube 909, the ink 823 may be injected into the skin.

The length of the guide tube 909 may be set so that the injection needle 821 may reach the target point located around the lesion point. That is, the length of the guide tube 909 is a value obtained by subtracting the distance from the skin to the target point from the length of the needle 821.

In a state in which the needle 821 is fully inserted into the guide tube 909, the ink 823 is injected little by little, and the syringe 820 is gradually removed from the guide tube 909 to form a dyeing column.

When the surgical guide 900 is removed, the surgical region is displayed as shown in FIG. 12C, and when the surgical region is unfolded after incision along the surgical region, the lesion region 1001 is exposed as shown in FIG. 12D, and the lesion region 1001 may be removed.

FIGS. 13 to 18 are flowcharts illustrating a surgical guide 900 generation method of the inventive concept.

Referring to FIG. 13, in the method of generating the surgical guide 900 of the inventive concept, a shape may be modeled by a computer using a surgical guide 900 program and then output to a 3D printer. Since it is a customized surgical guide 900 for each patient, it is easier to use a 3D printer than a mold manufacturing method because it does not mass-produce multiple units.

A basic surgical guide 900 generation method will be described with reference to FIG. 13.

A computer modeling program acquires body portion surface data and data of the treatment portion 1003 from medical image data (S2100). The medical image data refers to image data acquired through a medical image capturing device (e.g., a computed tomography (CT) device, a magnetic resonance imaging (MRI) imaging device, etc.).

First shape data of the body portion cover 902 corresponding to the body portion surface data may be generated (S2300). In the case of the surgical guide 900 for breast cancer surgery, the body portion is the breast, and the shape of the breast is changed according to postures of a patient, so that the body portion surface data may also be changed.

Therefore, as possible medical image data, data taken in the same posture as the surgical position may be used, and the body portion cover 902 may be made according to the first shape data having a curved surface corresponding to the shape of the body portion surface.

However, when the patient's posture is not the same as the surgical posture when the medical image data is taken, as shown in FIG. 14, based on the medical image data, it is possible to model the shape change based on the position change of the reference points and the density on the breast tissue to calculate the body portion surface data and the treatment target region data converted into the surgical position (S2200).

Second shape data corresponding to the safety boundary range 1008 is generated by calculating the safety boundary range 1008 including the treatment portion 1003 (S2400). The second shape data is data of the marking guide portion 907, and as described in FIG. 10, a safety boundary range 1008 greater than the treatment portion 1003 may be calculated, and the shape of the marking guide portion 907 may be designed accordingly.

The second shape data includes a plurality of marking holes 9071, and the length and number of marking holes 9071 may be determined according to the size of the treatment portion 1003, and the width of the marking hole 9071 may be determined in consideration of the width of the medical pen to generate the second shape data.

The surgical guide 900 data may be generated by merging the first shape data and the second shape data to model the body portion cover 902 in which the marking guide portion 907 is formed (S2800).

According to the flowchart of FIGS. 13 and 14, the surgical guide 900 in which the marking guide portion 907 is formed may be generated.

According to the flowchart of FIG. 15A, third shape data corresponding to the alignment reference portion 901 may be generated at a position corresponding to the main reference point 801 on the body portion (S2500). The main reference point 801 is a nipple of a breast in the surgical region, and the third shape data is the data of the hole-shaped alignment reference portion 901 located in the nipple.

By merging the first shape data and the third shape data, it is possible to model the body portion cover 902 in which the marking guide portion 907 and the alignment reference portion 901 are formed (S2810).

In addition, as shown in FIG. 15B, generation of fourth shape data for the alignment guide portion 906 indicating the positions of the

sub reference points

802 and 803 may be further included. The fourth shape data of the alignment guide portion 906 connecting between the

sub reference points

802 and 803 and the main reference point 801 located in other body portion other than the body portion is generated (S2600).

The

sub reference points

802 and 803 include at least one of the nipple and jugular notch point of the other breast, and the fourth shape data is data of a bar shape extending toward the

sub reference points

802 and 803 across the body portion cover 902.

By merging the first shape data to the fourth shape data, it is possible to model the body portion cover 902 in which the marking guide portion 907, the alignment reference portion 901, and the alignment guide portion 906 are formed (S2820).

In the case of providing the surgical guide 900 including the guide tube 909 as shown in FIG. 8A, an operation S2700 of FIG. 16 may be additionally performed.

Fifth shape data of the guide tube 909 positioned between the plurality of marking holes 9071 and into which the second medical instrument 820 is inserted may be generated (S2700). The fifth shape data may include data on the position, number, and length of the guide tube 909.

By merging the first shape data, the second shape data, and the fifth shape data, it is possible to model the body portion cover 902 in which the marking guide portion 907 and the guide tube 909 are formed (S2830).

The above-described method of producing the customized surgical guide 10 according to one embodiment of the inventive concept as described may be implemented using a program (or application) to be executed in combination with a computer as hardware, which may be stored in a medium.

The above-mentioned program may include codes encoded in a computer language such as C, C ++, JAVA, or machine language which the computer's processor (CPU) can read via a device interface of the computer. Thus, when the computer reads and executes the program, the program may perform the method. These codes may include functional codes related to functions that define necessary functions to execute the method, or may include executable procedure-related control codes necessary for the processor of the computer to execute the functions in accordance with a predetermined procedure. Further, these codes may further include memory reference-related code that indicates where additional information or media needed for the execution of the functions by the computer's processor is addressed to any location (address) in the computer's internal or external memory. Further, when the computer's processor needs to communicate with any other computer or server at a remote location to execute the functions, the codes may further include communication related codes indicating, for example, how to communicate with any other computer or server remotely using a communication module of the computer, and what information or media as transmitted or received therebetween during communication.

The storage medium is not a medium for storing data for a short time such as a register, a cache, a memory, etc., but means a medium that semi-permanently stores data and is capable of being read by a device. Specifically, examples of the storage medium include, but are not limited to, ROM, RAM, CD-ROM, magnetic tape, floppy disk, optical data storage, and the like. That is, the program may be stored on various recording media on various servers that the computer can access, or on various recording media on the user's computer. Further, the medium may store therein computer readable codes as distributed over a networked computer system and as read by the computer in a distributed manner.

According to the inventive concept as defined above, following various effects may be realized.

First, using the customized surgical guide 10 that assists in performing patient-customized surgery may allow optimal surgery for the patient. For example, when a to-be-removed lesion (for example, tumor) within the affected portion should be removed, the patient-customized surgical guide 10 is used to produce at least one dye column 30 in the body portion. The dye column may be used to allow the medical staff to visually check the to-be-removed region during surgery. Thus, the medical staff may remove a minimal tissue via two-or three-dimensional marking using the dye column 30.

Second, it is possible to align the surgical guide 900 in the correct position based on the reference point of the body portion, so that the accurate surgical region may be displayed. Even when the sub reference point is located on the outside of the surgical guide 900, the position may be aligned through the alignment guide portion 906, so that a sufficiently accurate surgical region may be displayed even with a small size surgical guide 900.

Third, it is possible to secure an operator's clear view by forming a body portion cover 902 only in a necessary region. In addition, the manufacturing cost can be reduced, so that the unit cost can be lowered and the manufacturing time can be shortened.

Fourth, since the guide tube 100 is produced by calculating a depth to the target point 40 based on the medical image data, the medical staff may perform the surgery without paying attention to the depth of insertion of the medical instrument, (for example, syringe). In other words, when the medical instrument is fully inserted into the guide tube 100 of the customized surgery guide, the medical instrument reaches the target point 40, so that the surgery can be easily performed.

Fifth, the body portion cover 200 is shaped to conform to the body portion shape, and the body portion cover 200 defines a position of the guide tube such that the medical instrument accurately reaches the target point 40 within the body portion. This prevents treatment from being performed on a wrong target point 40 or prevents erroneously marking in the body portion.

While the inventive concept has been described with reference to exemplary embodiments, it will be apparent to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the inventive concept. Therefore, it should be understood that the above embodiments are not limiting, but illustrative.

Claims

A customized surgical guide, comprising:

a body portion cover having a shape corresponding to a surface of a body portion including a treatment portion;

a marking guide portion formed on the body portion cover and including a marking hole through which a first medical instrument passes, and the treatment portion is positioned inside thereof;

an alignment reference portion formed at a position corresponding to a main reference point on a body portion on which the body portion cover is located; and

an alignment guide portion indicating a positional relationship between the main reference point and a sub reference point located on a different body portion other than the body portion, wherein,

the marking guide portion is configured to set a surgical region on the surface of the body portion including the treatment portion.
The customized surgical guide of claim 1, wherein,

the body portion is a breast,

the alignment reference portion is a hole through which a nipple of the breast passes, which is the main reference point, and

the alignment guide portion is a straight member extending from the hole.
The customized surgical guide of claim 2, wherein,

the alignment guide portion includes a first alignment guide portion toward a nipple of a breast, which is the sub reference point, other than the body portion.
The customized surgical guide of claim 3, wherein,

the alignment guide portion includes a second alignment guide portion toward a jugular notch point, which is a sub reference point.
The customized surgical guide of claim 2, wherein,

the body portion cover is a mesh shape including a plurality of holes, and

the alignment guide portion is a solid bar shape in which no holes are formed.
The customized surgical guide of claim 1, wherein,

the body portion cover has a honeycomb structure including a plurality of hexagonal holes.
The customized surgical guide of claim 1, wherein,

the marking guide portion includes a plurality of marking holes formed along the periphery of the surgical region.
The customized surgical guide of claim 1, wherein,

the marking hole has a width equal to or greater than the width of a first medical instrument and a length greater than the width, and extends along the periphery of the surgical region.
The customized surgical guide of claim 1, further comprising:

a guide tube into which a second medical instrument is inserted, wherein, the guide tube is formed along the marking guide portion.
The customized surgical guide of claim 9, wherein,

the marking guide portion includes a plurality of marking holes formed along the periphery of the surgical region, and

the guide tube is positioned between the adjacent marking holes.
The customized surgical guide of claim 9, wherein,

the second medical instrument includes a first portion smaller than a guide tube diameter and a second portion greater than the guide tube diameter, and

the length of the guide tube corresponds to the difference between the length of the first portion of the second medical instrument and the distance from the surface of the body portion to a target point.
The customized surgical guide of claim 1, wherein,

the body portion cover is a mesh shape including a plurality of holes, and

an inner side of the marking guide portion is a solid shape in which no holes are formed.
A method of manufacturing a customized surgical guide, the method comprising:

obtaining body portion surface data and treatment portion data from medical image data;

generating first shape data of a body portion cover corresponding to the body portion surface data;

calculating a safety boundary range including the treatment portion, and generating second shape data of a marking guide portion corresponding to the safety boundary range; and

modeling the body portion cover on which the marking guide portion is formed by merging the first shape data and the second shape data.
The method of claim 13, wherein the safety boundary range is spaced apart from the treatment portion by a predetermined distance.
The method of claim 13, further comprising:

generating third shape data of an alignment reference portion at a position corresponding to a main reference point on the body portion, wherein,

the modeling of the body portion cover includes merging the first shape data to the third shape data and modeling the body portion cover including the alignment reference portion.
The method of claim 15, further comprising:

generating fourth shape data of an alignment guide portion connecting between a sub reference point located on a different body portion other than the body portion and the main reference point, wherein,

the modeling of the body portion cover includes merging the first shape data to the fourth shape data and modeling the body portion cover including the alignment guide portion.
The method of claim 16, wherein,

the body portion is a breast,

the third shape data has a hole shape through which a nipple of the breast, which is the main reference point, passes, and

the fourth shape data is a linear shape extending from the third shape data toward at least one of a nipple point of a breast or a jugular notch point other than the body portion, which is the sub reference point.
The method of claim 13, wherein,

the second shape data includes a plurality of marking holes formed on the body portion cover along the safety boundary range,

further including, generation of a fifth shape data of a guide tube into which a second medical instrument positioned between the plurality of marking holes is inserted, wherein,

the modeling of the body portion cover models the body portion cover including the guide tube by merging the fifth shape data.
The method of claim 13, wherein,

when the body portion surface data is obtained from a second posture different from a first posture during surgery, converting it into the first posture and calculating the body portion surface data and the treatment portion.
A customized surgical guide generating program, combined with a computer that is a hardware, and stored in a medium to execute the method of any one of claims 15 to 20.