Patent AU-2020210171-A1 (AU)
Title: Customized surgical guide and customized surgical guide generating method and generating program
Inventor: LEE JONG WON
IPC: A61B17/34
Filed: 2020-07-28
Abstract: CUSTOMIZED SURGICAL GUIDE AND CUSTOMIZED SURGICAL 
GUIDE GENERATING METHOD AND GENERATING PROGRAM 
CROSS-REFERENCE TO RELATED APPLICATIONS 
5 [0001] The present application is a divisional application of Australian Patent 
2017361460, which is a continuation of International Patent Application No.  
PCT/KR2017/012906, filed November 15, 2017, which is based upon and claims the 
benefit of priority to Korean Patent Application No. 10-2016-0152885, filed on 
November 16, 2016. The disclosures of the above-listed applications are hereby 
10 incorporated by reference herein in their entirety.  
BACKGROUND 
[0002] Embodiments of the inventive concept described herein relate to a 
customized surgical guide, and a customized surgical guide producing method, and a 
15 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.  
[0003] In surgery, medical staffs measure a region to be subjected to surgery 
20 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.  
25 [0004] Further, a removal area on a skin surface is marked before surgery is 
1
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 
5 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.  
SUMMARY 
10 [0005] Embodiments of the inventive concept provide 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 
15 region.  
[0006] Further, embodiments of the inventive concept provide 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 
20 guide producing method, and a producing program.  
[0007] The purposes to be achieved by the inventive concept 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.  
[0008] According to an exemplary embodiment, a customized surgical guide 
25 includes at least one guide tube through which a medical instrument is insertable; and 
2
a body portion cover covering a surface of a specific body portion, wherein the body 
portion cover is coupled to the at least one guide tube. The body portion cover has a 
hole defined therein through which the medical instrument passes. The medical 
instrument passes through the guide tube and then through the hole toward the body 
5 portion. The body portion cover is shaped to conform to a surface of the body portion 
of a patient. The body portion cover defines a position of the guide tube such that the 
medical instrument reaches a target point within the body portion. The guide tube has 
a larger inner diameter than an outer diameter of the medical instrument. The guide 
tube has a length sized such that an insertable depth of the medical instrument into 
10 the body is limited to a set depth from a first point to the target point. The first point 
is present on the surface of the body portion, and the guide tube is coupled to the 
body portion cover at a position thereof corresponding to the first point. The target 
point is present on a surface of or inside a treatment target region, or is spaced by a 
specific distance from the treatment target region.  
15 [0009] According to the inventive concept as defined above, following 
various effects may be realized.  
[0010] 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 
20 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.  
25 [0011] Second, since the guide tube is produced by calculating a depth to the 
3
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 
5 the target point, so that the surgery can be easily performed.  
[0012] Third, 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 
10 prevents erroneously marking in the body portion.  
[0013] Fourth, even when there is a difference between a posture of the 
patient at which the medical image data is obtained and a posture of the patient at 
which the surgery is performed, the customized surgical guide may allow the medical 
instrument to accurately reach the target point.  
15 
BRIEF DESCRIPTION OF THE FIGURES 
[0014] 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 
20 specified, and wherein: 
[0015] FIG. 1 is a perspective view of a customized surgical guide according 
to one embodiment of the inventive concept.  
[0016] FIG. 2 is an illustration of a customized surgical guide attached to a 
body portion according to one embodiment of the inventive concept.  
25 [0017] FIG. 3 is an illustration of forming a dye column from a target point 
4
of a treatment target region surface through a guide tube according to one 
embodiment of the inventive concept.  
[0018] FIG. 4 is a flowchart of a customized surgical guide producing 
method according to one embodiment of the inventive concept.  
5 [0019] 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 one 
embodiment of the inventive concept.  
[0020] FIG. 6 is a flowchart of a customized surgical guide producing 
10 method further including requesting injection based on last shape data according to 
one embodiment of the inventive concept.  
[0021] FIG. 7 is a flowchart illustrating a process of producing a body 
portion cover shape covering an entire body portion according to one embodiment of 
the inventive concept.  
15 
DETAILED DESCRIPTION 
[0022] A customized surgical guide according to one embodiment of the 
inventive concept includes at least one guide tube through which a medical 
instrument is insertable; and a body portion cover covering a surface of a specific 
20 body portion. The body portion cover is coupled to the at least one guide tube. The 
body portion cover has a hole defined therein through which the medical instrument 
passes. The medical instrument passes through the guide tube and then through the 
hole toward the body portion. The body portion cover is shaped to conform to a 
surface of the body portion of a patient. The body portion cover defines a position of 
25 the guide tube such that the medical instrument reaches a target point within the body 
5
portion. The guide tube has a larger inner diameter than an outer diameter of the 
medical instrument. The guide tube has a length sized such that an insertable depth of 
the medical instrument into the body is limited to a set depth from a first point to the 
target point. The first point is present on the surface of the body portion, and the 
5 guide tube is coupled to the body portion cover at a position thereof corresponding to 
the first point. The target point is present on a surface of or inside a treatment target 
region, or is spaced by a specific distance from the treatment target region.  
[0023] Further, when the medical instrument is a syringe with a specific 
needle length, the guide tube may be formed so that the syringe needle reaches the 
10 target point, and the target point may be a specific point on a surface of the treatment 
target region in the body portion. While the syringe is removed away from the target 
point through the guide tube, the syringe may supply dye to form a dye column in the 
body portion.  
[0024] Further, when the medical instrument performs treatment on a 
15 treatment range defined as a specific range from a specific point which the inserted 
medical instrument reaches, the target point may be at least one specific point located 
within the treatment target region, and the at least one specific point may define at 
least one treatment range covering the treatment target region. A number of the guide 
tubes may be equal to a number of the target points, and each guide tube may be 
20 formed on the first point of the body portion cover and extends in a direction from 
the first point toward each target point.  
[0025] Further, the body portion cover may be formed to conform to body 
surface acquired based on medical image data. The guide tube may have a length set 
based on a distance on the medical image data from the first point on the body 
25 surface to the target point that the medical instrument should reach.  
6
[0026] Further, the customized surgical guide may be made of deformable 
material and may be inserted using a laparoscope into the body and then be placed on 
the body portion surface.  
[0027] Further, when the body portion including the treatment target region 
5 has a shape varying according to a posture of the patient, the body portion cover may 
cover the body portion and may fix a shape of the body portion into a specific shape.  
[0028] Further, when a distal end of the medical instrument reaches the target 
point, the guide tube may be fitted with the medical instrument.  
[0029] A method of producing a customized surgical guide according to 
10 another embodiment of the inventive concept, the guide including a guide tube 
through which a medical instrument is inserted, and a body portion cover contacting 
a body surface, includes acquiring, by a computer, body surface data and treatment 
region data from medical image data; generating, by the computer, first shape data 
based on the body surface data, the first shape data defining a shape of the body 
15 portion cover; setting, by the computer, at least one target point, the target point 
being present on a surface of or inside a treatment target region; setting, by the 
computer, each first point on the body surface from which the medical instrument is 
accessible to the target point; setting, by the computer, a length of the guide tube 
based on a distance from the first point to the target point; and applying, by the 
20 computer, the guide tube length to the first point to generate last shape data as a 
combination between the first shape data and shape data of at least one guide tube.  
[0030] Further, when the medical instrument is a syringe with a specific 
needle length, the target point may be a specific point on a surface of the treatment 
target region in the body portion. While the syringe may be removed away from the 
25 target point through the guide tube, the syringe may supply dye to form a dye column 
7
in the body portion.  
[0031] Further, when the medical instrument performs treatment on a 
treatment range defined as a specific range from a specific point which the inserted 
medical instrument reaches, the target point may be at least one specific point located 
5 within the treatment target region. The setting of the at least one target point may 
include setting at least one target point to define at least one treatment range covering 
the treatment target region.  
[0032] Further, the generating of the first shape data may include: obtaining 
entire shape data of the body portion; and generating shape data of the body portion 
10 cover covering a specific body portion based on the entire shape data. The body 
portion cover may cover the body portion and fixes a shape of the body portion into a 
specific shape.  
[0033] Further, when a first posture of a patient at which the medical image 
data is taken and a second posture of the patient at which surgery is performed are 
15 different, the method may further include calculating a positional change of the 
treatment target region when a posture of the patient changes from the first posture to 
the second posture. The setting of the at least one target point, the setting of each first 
point, and the setting of the length of the guide tube may be performed based on the 
changed position of the treatment target region.  
20 [0034] Further, the setting of the first point may include setting the first point 
from which the medical instrument reaches the target point without passing through 
the treatment target region.  
[0035] Further, when the medical instrument is curved at a specific curvature, 
the setting of the first point may include setting the first point from which the 
25 medical instrument reaches the target point while moving along a curved path having 
8
the specific curvature within the body. The generating of the last shape data may 
include generating curvature data of the guide tube equal to the curvature of the 
medical instrument.  
[0036] A customized surgical guide producing program according to still 
5 another embodiment of the inventive concept may be stored in a medium for carrying 
out the customized surgical guide producing method in combination with a computer 
as hardware.  
[0037] Hereinafter, preferred embodiments of the inventive concept will be 
described in detail with reference to the accompanying drawings. Advantages and 
10 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 
15 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.  
[0038] Unless otherwise defined, all terms including technical and scientific 
20 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 
25 sense unless expressly so defined herein.  
9
[0039] 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 
5 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.  
10 [0040] 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
15 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.  
[0041] As used herein, a term "medical image data" means image data 
obtained by medical imaging devices such as Computed Tomography (CT) device, 
20 MRI (Magnetic Resonance Imaging) device or the like.  
[0042] 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 
25 actually larger than the affected region with considering an error range.  
10
[0043] 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 
5 into a specific body portion and applies electrical stimulation to a specific range.  
[0044] 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 
10 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.  
[0045] 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 
15 guide tube is placed when placing a customized surgical guide in the body portion.  
[0046] 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.  
[0047] FIG. 1 is an illustration of a customized surgical guide 10 according to 
20 one embodiment of the inventive concept.  
[0048] 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.  
[0049] The guide tube 100 refers to a tube into which a medical instrument 
25 can be inserted. The guide tube 100 has a larger diameter than that of a portion of the 
11
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 
5 100 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 
10 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 
15 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 
20 body.  
[0050] 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 
25 MRI image to calculate the distance from the specific first point on the surface of the 
12
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 
5 surgical guide 10 based on the patient's treatment target region 20.  
[0051] 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 
10 guide tubes 100 as produced may correspond to the number of the target points 40.  
[0052] 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 
15 is invaded or inserted into the body portion along an extension of the guide tube 100.  
[0053] 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 
20 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 
25 the medical instrument is inserted into the guide tube 100 of the customized surgical 
13
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.  
5 [0054] 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 
10 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.  
[0055] In yet another embodiment, when a body portion including the 
15 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 
20 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 
25 breast, the body portion cover 200 may be made in the same shape as a brassiere, and 
14
may be worn on the patient during breast cancer surgery.  
[0056] 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 
5 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 
10 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.  
15 [0057] 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 
20 of the body portion surface.  
[0058] 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 
25 40. Thus, the point corresponding to the boundary of the treatment target region 20 
15
may be confirmed in the surgical procedure.  
[0059] 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 
5 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 
10 electricity thereto.  
[0060] 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 
15 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 
20 instrument to the target points 40 set according to the patient surgery plan.  
[0061] 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, 
25 the customized surgical guide 10 is made of a material that can be deformed in shape 
16
and is inserted to a specific body portion inside the body using the laparoscope while 
the guide is folded or wound.  
[0062] 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 
5 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 
10 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 
15 instrument maintains a state in which the medical instrument reaches the target point 
40 and is fixed thereto.  
[0063] FIG. 4 is a flowchart of a producing method of a customized surgical 
guide 10 according to one embodiment of the inventive concept.  
[0064] Referring to FIG. 4, a producing method of a customized surgical 
20 guide 10 according to one embodiment of the inventive concept may include 
operation Si00 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 
25 cover 200; target point setting operation S500 in which at least one target point 40 is 
17
set by the computer, wherein the target point40isapoint 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 
5 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 
10 operation will be described.  
[0065] 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 
15 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.  
[0066] 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 
20 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.  
[0067] Further, the computer sets, as the reference point 300, a point on the 
25 first shape data corresponding to a specific point on the body surface data. For 
18
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.  
5 [0068] 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, 
10 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 
15 the medical image data, and then models the body portion cover 200 into a shape 
covering the entire body portion.  
[0069] 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 
20 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 
25 image data during surgery. Therefore, the computer models the cover into the shape 
19
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.  
[0070] The computer sets at least one target point 40 (S500: target point 
5 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 
10 the target point 40.  
[0071] 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).  
15 [0072] 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 
20 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.  
25 [0073] The computer sets each first point on the body surface, wherein the 
20
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 
5 boundary of the tumor region.  
[0074] 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 
10 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 
15 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.  
[0075] Further, the computer sets an orientation angle of the guide tube 100 
20 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 
25 40.  
21
[0076] 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 
5 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 
10 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 
15 the target point 40 and the first point).  
[0077] 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 
20 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 
25 the tumor region accurately when the needle is inserted through each of the guide 
22
tubes.  
[0078] 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 
5 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.  
10 [0079] 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.  
15 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 
20 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.  
25 [0080] For example, among the body portions, the breast changes the shape 
23
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 
5 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 
10 treatment target region 20).  
[0081] 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 
15 position of the treatment target region 20.  
[0082] 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 
20 data.  
[0083] 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 
25 body. In this case, the curved medical instrument may be used. In order to insert the 
24
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.  
5 [0084] 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 
10 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.  
[0085] Further, the last shape data generating operation SI100 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 
15 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.  
[0086] 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 
20 the guide corresponding to the modeled last shape data to a 3D injection device, that 
is, a 3D printer.  
[0087] 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 
25 computer as hardware, which may be stored in a medium.  
25
[0088] 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 
5 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 
10 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 
15 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.  
[0089] 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
20 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, 
25 the medium may store therein computer readable codes as distributed over a 
26
networked computer system and as read by the computer in a distributed manner.  
[0090] According to the inventive concept as defined above, following 
various effects may be realized.  
[0091] First, using the customized surgical guide 10 that assists in performing 
5 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 
10 medical staff may remove a minimal tissue via two-or three-dimensional marking 
using the dye column 30.  
[0092] Second, 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 
15 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.  
[0093] Third, 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 
20 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.  
[0094] Fourth, even when there is a difference between a posture of the 
patient at which the medical image data is obtained and a posture of the patient at 
25 which the surgery is performed, the customized surgical guide 10 may allow the 
27
medical instrument to accurately reach the target point.  
[0095] 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 
5 of the inventive concept. Therefore, it should be understood that the above 
embodiments are not limiting, but illustrative.  
28
WHAT IS CLAIMED IS: 
1. A customized surgical guide comprising: 
at least one guide tube through which a medical instrument is insertable; and 
a body portion cover covering a surface of a specific body portion, wherein 
5 the body portion cover is coupled to the at least one guide tube, wherein the body 
portion cover has a hole through which the medical instrument passes, wherein the 
medical instrument passes through the guide tube and then through the hole toward 
the body portion, 
wherein the body portion cover is shaped to conform to a surface of the body 
10 portion of a patient, wherein the body portion cover defines a position of the guide 
tube such that the medical instrument reaches a target point within the body portion, 
wherein the guide tube has a larger inner diameter than an outer diameter of 
the medical instrument, wherein the guide tube has a length sized such that an 
insertable depth of the medical instrument into the body is limited to a set depth from 
15 a first point to the target point, 
wherein the first point is present on the surface of the body portion, and the 
guide tube is coupled to the body portion cover at a position thereof corresponding to 
the first point, 
wherein the target point is present on a surface of or inside a treatment target 
20 region, or is spaced by a specific distance from the treatment target region.  
2. The customized surgical guide of claim 1, wherein when the medical 
instrument is a syringe with a specific needle length, the guide tube is formed so that 
the syringe needle reaches the target point, wherein the target point is a specific point 
25 on a surface of the treatment target region in the body portion, wherein while the 
29
syringe is removed away from the target point through the guide tube, the syringe 
supplies dye to form a dye column in the body portion.  
3. The customized surgical guide of claim 1, wherein when the medical 
5 instrument is configured to perform treatment on a treatment range defined as a 
specific range from a specific point which the inserted medical instrument reaches, 
the target point is at least one specific point located within the treatment target region, 
wherein the at least one specific point defines at least one treatment range covering 
the treatment target region, wherein a number of the guide tubes is equal to a number 
10 of the target points, wherein each guide tube is formed on the first point of the body 
portion cover and extends in a direction from the first point toward each target point.  
4. The customized surgical guide of claim 1, wherein the body portion 
cover is formed to conform to body surface acquired based on medical image data, 
15 and wherein the guide tube has a length set based on a distance on the medical image 
data from the first point on the body surface to the target point that the medical 
instrument should reach.  
5. The customized surgical guide of claim 1, wherein the customized 
20 surgical guide is made of deformable material and is inserted using a laparoscope 
into the body and then is placed on the body portion surface.  
6. The customized surgical guide of claim 1, wherein when the body 
portion including the treatment target region has a shape varying according to a 
25 posture of the patient, the body portion cover covers the body portion and fixes a 
30
shape of the body portion into a specific shape.  
7. The customized surgical guide of claim 1, wherein when a distal end 
of the medical instrument reaches the target point, the guide tube is fitted with the 
5 medical instrument.  
8. A method of producing a customized surgical guide, the guide 
including a guide tube through which a medical instrument is inserted, and a body 
portion cover contacting a body surface, the method comprising: 
10 acquiring, by a computer, body surface data and treatment region data from 
medical image data; 
generating, by the computer, first shape data based on the body surface data, 
the first shape data defining a shape of the body portion cover; 
setting, by the computer, at least one target point, the target point being 
15 present on a surface of or inside a treatment target region; 
setting, by the computer, each first point on the body surface from which the 
medical instrument is accessible to the target point; 
setting, by the computer, a length of the guide tube based on a distance from 
the first point to the target point; and 
20 applying, by the computer, the guide tube length to the first point to generate 
last shape data as a combination between the first shape data and shape data of at 
least one guide tube.  
9. The method of claim 8, wherein when the medical instrument is a 
25 syringe with a specific needle length, the target point is a specific point on a surface 
31
of the treatment target region in the body portion, wherein while the syringe is 
removed away from the target point through the guide tube, the syringe supplies dye 
to form a dye column in the body portion.  
5 10. The method of claim 8, wherein when the medical instrument is 
configured to perform treatment on a treatment range defined as a specific range 
from a specific point which the inserted medical instrument reaches, the target point 
is at least one specific point located within the treatment target region, wherein the 
setting of the at least one target point includes setting at least one target point to 
10 define at least one treatment range covering the treatment target region.  
11. The method of claim 8, wherein the generating of the first shape data 
includes: 
obtaining entire shape data of the body portion; and 
15 generating shape data of the body portion cover covering a specific body 
portion based on the entire shape data, 
wherein the body portion cover covers the body portion and fixes a shape of 
the body portion into a specific shape.  
20 12. The method of claim 8, wherein when a first posture of a patient at 
which the medical image data is taken and a second posture of the patient at which 
surgery is performed are different, the method further comprises calculating a 
positional change of the treatment target region when a posture of the patient changes 
from the first posture to the second posture, 
25 wherein the setting of the at least one target point, the setting of each first 
32
point, and the setting of the length of the guide tube are performed based on the 
changed position of the treatment target region.  
13. The method of claim 9, wherein the setting of the first point includes 
5 setting the first point from which the medical instrument reaches the target point 
without passing through the treatment target region.  
14. The method of claim 8, wherein when the medical instrument is 
curved at a specific curvature, the setting of the first point includes setting the first 
10 point from which the medical instrument reaches the target point while moving along 
a curved path having the specific curvature within the body, 
wherein the generating of the last shape data includes generating curvature 
data of the guide tube equal to the curvature of the medical instrument.  
15 15. A customized surgical guide producing program stored in a medium 
for carrying out the method of one of claims 8 to 14 in combination with a computer 
as hardware.  
20 
33
ABSTRACT 
The present invention relates to a customized surgical guide device and a 
customized surgical guide generating method and program. A customized surgical 
guide generating method according to another embodiment of the present invention 
5 comprises the steps of: acquiring body surface data and treatment area data from 
medical image data by a computer (S100); a first shape data generating step of 
generating first shape data on the basis of the body surface data, wherein the first 
shape data is data which corresponds to the shape of the body part cover (S300); a 
target point setting step of setting one or more target points, wherein the target point 
10 is a point which corresponds to the inside or the surface of an area to be treated 
(S500); setting individual first points on the body surface accessible to the target 
point with a medical tool (S700); setting a guide tube length on the basis of a 
distance from the first point to the target point (S900); and generating final shape 
data in which one or more guide tubes are combined to the first shape data by 
15 applying the guide tube length to the first point (S1100).  
34