KR101857527B1

KR101857527B1 - Method for manufacturing customized nasal implant

Info

Publication number: KR101857527B1
Application number: KR1020160017611A
Authority: KR
Inventors: 최병억; 강소원
Original assignee: 최병억; 강소원
Priority date: 2016-02-16
Filing date: 2016-02-16
Publication date: 2018-05-14
Also published as: KR20170096344A

Abstract

The present invention relates to a method of manufacturing a patient-customized nasal implant, and more particularly, to a method of manufacturing a patient-customized nasal implant, comprising: a first step of acquiring a stereoscopic image through volume rendering using a medical diagnostic apparatus; A second step of displaying a reference point of two points or less in the face image of the patient; And a third step of implementing a cartilage stereoscopic image of the nose using the image information of the skin and the bone from the displayed reference point.

Description

[0001] The present invention relates to a method for manufacturing a customized nasal implant,

The present invention relates to a patient-customized nasal implant and a method of making the same, and more particularly, to a patient-customized nasal implant conforming to a nasal shape of a patient using a three-dimensional stereoscopic image of a patient and a method of manufacturing the nasal implant. More specifically, in the case of a conventional nasal implant, the process of reducing the error of the patient's nasal configuration by carving the nasal implant during manual operation is not reflected in the patient's nasal shape, The present invention relates to a patient-customized nasal implant and a method of manufacturing the same.

As modern society is rapidly diversified and diversified, interest and value standards for appearance are changing. As a result, cosmetic surgery, which changes and complements appearance through surgical operations, is being performed to restore confidence in social life and to lead a better life.

In particular, among the facial parts, which occupy the largest portion of the aesthetic standards, rhinoplasty is becoming popular due to the tendency of the nose to prefer big and high like Westerners.

Such nose surgery may be roughly performed (nose-up cosmetic surgery), surgery to lower the nose, surgery to repair the nose, and additional nose surgery to widen or narrow the size of the nostril. The above-mentioned lubrication technique is a procedure for raising a flat nose against the face. There are various procedures such as raising the entire nose, raising only the nose portion of the nose, or raising only the nose tip. The overall height of the nose is generally a rigid form Of the artificial inser- tion (also called implant). For reference, the structure of the nose is that the upper third part of the nose is composed of a pair of Nazurbones and the lower 2/3 part consists of two pairs of cartilages. The conventional cochlear implant is an L-shaped configuration so that it can be inserted and positioned integrally with a portion of the nose at the right angle from the tip of the nose while being positioned at the nose of the nose of the nose. Hereinafter, the name of the artificial implant having the shape of L-shape will be described as follows. A side surface of the narrow portion where the width is narrowed from the rounded portion while being positioned on the bottom surface side of the nose, that is, inside the nose So that it can be naturally positioned at the nose of the nose. The length of the narrow portion may be cut according to the height of the nose of the recipient or may be used by gently cutting the round portion. However, after the insertion of the artificial inserting portion inserted into the nose, If the shape is not satisfactory, the following occurs. The narrow part of the artificial implant is located in a non-communicating region that divides the nostrils (nostrils), which is not fluid and can not be inserted into the nostrils when not breathing, A pain was felt by pressing the area or even the rounding part of the artificial implant, that is, the part of the vertex was protruding out of the skin. In addition, the artificial insert inserted into the nose is made of one silicone material, and the nose portion of the nose appearing on the appearance of the nose is prominently protruded according to the hardness of the material, This was dissatisfied with the feeling of shame in the nose surgery.

Korean Patent Laid-Open Publication No. 2015-0087788 discloses a technique in which an implant optimized for individual patients is manufactured using 3D imaging technology and a customized implant is inserted into a patient, thereby reducing the intraoperative variables caused by the implant being incompatible with the human body, Furthermore, by using customized implants made by individual patients, not only the operation time can be shortened, but also the standardization of the surgical technique and the method of making the implant to be able to predict the surgical result of the patient more precisely before the operation are disclosed.

In Korean Patent Laid-Open Publication No. 2009-0014112, separate renderings are performed on the data of the same medical image mode so as to enhance the desired image information, the data is processed differently and / or rendered differently prior to rendering, Mode data is rendered by opacity rendering and by maximum intensity projection or surface rendering so that the surface or maximum intensity projection highlights strong transitions associated with the bones and opacity rendering maintains tissue information and different sets of B- The data may be rendered separately, e.g., one set is processed to emphasize the contrast agent response and the other set is processed to highlight the tissue so that separate renderings are aligned and combined so that the combined renderings are output as images Of medical diagnostic imaging Emitter has been disclosed using a volume rendering technique.

In Korean Patent Laid-Open Publication No. 2010-0023420, a liquid silicon raw material is injected into a first metal mold composed of upper and lower dies, heated, pressed and cured by using a press to form a soft portion; A hard silicon raw material having hardness different from that of the silicon raw material of the soft portion is injected into the raw material injection portion to fill the hardened soft portion in the first mold so as to be fit into the raw material injection portion of the second mold, Heating, pressing and curing to form the soft part and the hard part into one body; After cutting the boundary portion between the soft portion and the hard portion and disposing the soft portion and the hard portion excluding the cut portion in the material injection portion of the second mold so as to have a clearance therebetween, the hard portion of the soft portion and the hard portion, And a step of injecting a liquid silicon raw material constituting the silicon raw material into a gap portion between the soft portion and the hard portion and heating and pressurizing and hardening the same to integrate the soft portion and the hard portion and the heterogeneous portion having different hardness And a method of manufacturing the same.

Because the lower part of the nose consists of cartilage in the anatomical structure, it is preferable to use autologous cartilage such as ear cartilage or septum cartilage with little foreign body reaction and excellent tactile and absorption rate. However, And the need for additional surgery.

As a result, it is inexpensive, harmless to the human body, can be finely sculpted to fit the shape of the bone, and silicone implants that do not change in size or shape after surgery are commonly used

However, no technique has been presented to confirm patient-specific nasal implants in a short time before surgery and to reflect them in the production of implants.

Korean Patent Laid-Open Publication No. 2015-0087788 Korean Patent Laid-Open Publication No. 2009-0014112 Korean Patent Laid-Open Publication No. 2010-0023420

These problems are inexpensive, harmless to the human body, and can be finely sculpted to fit the shape of the bone. Silicone implants, which have no change in size or shape after surgery, are commonly used. However, No technique has been proposed to confirm the 3D image information within a short time before operation and to reflect it in the production of implant.

The main object of the present invention is to provide a patient-customized nasal implant conforming to the shape of a patient's nose using the three-dimensional shape of the patient and a method of manufacturing the nasal implant. More specifically, in the case of a conventional nasal implant, the process of reducing the error of the patient's nasal configuration by carving the nasal implant during manual operation is not reflected in the patient's nasal shape, A patient-customized nasal prosthesis for manufacturing a nasal prosthesis best suited to a nasal configuration, and a method for manufacturing the same.

SUMMARY OF THE INVENTION Accordingly, the present invention has been made keeping in mind the above problems occurring in the prior art, and an object of the present invention is to provide a method of manufacturing a patient-customized nasal prosthesis, the method comprising: a first step of acquiring a stereoscopic image through volume rendering using a medical diagnostic apparatus; A second step of displaying a reference point of two points or less in the face image of the patient; And a third step of implementing a cartilage stereoscopic image of the nose using the image information of the skin and the bone from the displayed reference point.

In addition, the step of determining the stereoscopic image information of the region of interest among the stereoscopic images to reduce the data loading time may be further included.

The determination of the stereoscopic image information of the ROI as an image means that only stereoscopic image information directly related to the design of the nasal prosthesis among all the stereoscopic image information is used as an image having the stereoscopic image information data. For example, among the stereoscopic image information obtained through the optical image processing device such as CT, only the image of the stereoscopic image information about the nose portion directly related to the nose implant design is held, and the stereoscopic image information of the other regions is fixed Dimensional image information, it is possible to shorten the program data loading time for the simulation of stereoscopic image information and to perform smooth simulation. The stereoscopic image information of the region of interest related to the nasal implant design can be variously changed according to the patient or nasal implant manufacturing conditions.

Also, the region of interest may be three-dimensional shape information between 20 mm to the right and left of the nacion, 20 mm to the back, 10 mm to the upper side of the nacion, and 30 mm to the bottom of the linnion.

Also, the region of interest may be three-dimensional shape information realized by recognizing two points where the curvature value of the nose changes.

In addition, when the reference point of the second step is two points, the reference point may be a nacion and / or a lignion.

If the reference point of the second step is one point, the nacion may be displayed and the other point may be automatically displayed from the patient's face stereoscopic information.

In addition, the patient's face stereoscopic information may be Lignon.

The cartridge stereoscopic shape in the third step can be obtained by moving the skin stereoscopic information to the stereoscopic information by the distance between the skin and the main body of the patient based on the boundary between the main body and the cartridge so as to derive a cartilage stereoscopic image of the nose have.,

Further, the boundary between the pattern and the cartridge may be Lignion.

In the third step, the algorithm for minimizing the side portion error using the interval between the left and right skins of the patient on the basis of the cross section of the linone can be used.

In addition, the cartridge solid shape in the third step can derive the cartilage three-dimensional shape of the nose by using the correlation between skins, mucous membranes, cartridges and bone in the collected patient DB.

And selecting the implant from one or more implant libraries in the 3D rendered nasal stereoscopic image to produce patient-specific nasal implant stereoscopic information.

The method may further include the step of fabricating a patient-customized nasal prosthesis using a processing device capable of applying the manufactured patient-customized nasal implant stereoscopic information.

In addition, the image may be any one of X-ray, CT (Computer Tomography), MRI (Magnetic Resonance Imaging) and PET (Positron Emission Tomography).

The method may further include coating the surface of the implant with at least one of a biocompatible material, a functional drug, and a functional material.

In addition, the implant may be a biodegradable material in the implant preparation step.

According to the method of making a patient-customized implant according to the present invention, it is possible to reduce the intraoperative variables caused by the inconsistency with the human body by preparing the optimized implant for each individual patient and inserting the customized implant to the patient.

The designed nose implant 3D model of the present invention can be output in a format applicable to various processing systems such as a CNC machine and 3D printing. Also, it is possible to produce a clinical nose implant through drawings and prototypes There is one advantage.

In addition, by creating an optimized prosthesis for each individual patient, the surgical result of the patient can be predicted more accurately before the surgery. Therefore, satisfaction with the results of the patients who have undergone plastic surgeon's plastic surgery now gives the same satisfaction and avoids responsibility for dissatisfaction with the shape of the nose after the procedure There are advantages to be able to.

In addition, by using customized implants made by individual patients, not only the operation time can be shortened, but also standardization of diagnostic equipment can be achieved.

In addition, in the present invention, the height, width, and length of the carving operation, which is performed manually during the operation, can not be known accurately and depend on the senses. However, when manipulating the stereoscopic image through simulation, have.

Although the present invention has been described in connection with the preferred embodiments set forth above, it will be readily appreciated by those skilled in the art that various other modifications and variations can be made without departing from the spirit and scope of the invention, It is obvious that the present invention belongs to the appended claims.

1 is a volume rendered three-dimensional image image according to an embodiment of the present invention.
FIG. 2 is a video image in which two reference points are displayed on a face image of a patient, which is an embodiment of the present invention.
FIG. 3 is a picture image of a cartridge stereoscopic shape of a nose using a displayed reference point, which is one embodiment of the present invention.
4 is a view showing an image of a region of interest in a cartridge stereoscopic image of a nose according to an embodiment of the present invention.
FIG. 5 is a stereoscopic image of a whole face image and a region of interest of a patient according to one embodiment of the present invention. FIG.
FIG. 6 is a synthesized image after extracting only a region of interest of the nose according to an embodiment of the present invention.
7 is a stereoscopic image illustrating a cartridge using a tilt value of a nose according to an embodiment of the present invention.
8 is a stereoscopic image image for understanding the thickness of the nasal prosthesis, which is one embodiment of the present invention.
FIG. 9 is a stereoscopic image image in which a lineion is set, which is one embodiment of the present invention.
FIG. 10 is an image showing cross-sectional information of a stereoscopic image for minimizing a skew and a side portion error of a bone, which is one embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. However, the detailed description of known functions and configurations incorporated herein will be omitted when it may unnecessarily obscure the subject matter of the present invention.

The same reference numerals are used for portions having similar functions and functions throughout the drawings. Throughout the specification, when a part is connected to another part, it includes not only a case where it is directly connected but also a case where the other part is indirectly connected with another part in between. In addition, the inclusion of an element does not exclude other elements, but may include other elements, unless specifically stated otherwise.

The present invention will be described in detail with reference to the drawings. 1. A method of making a patient-customized nasal implant, comprising: a first step of acquiring a stereoscopic image through volume rendering using a medical diagnostic device on a face of a patient; A second step of displaying a reference point of two points or less in the face image of the patient; And a third step of implementing a cartilage stereoscopic image of the nose using the image information of the skin and the bone from the displayed reference point.

The second step is a step of displaying Nasion and Rhinion, and FIG. 2 is a stereoscopic image showing Nascion and Linion. Typically from the patient stereoscopic image information, the lowest point of the patient's nose in the skin or Nazarene is the Nazion, and the highest point in Nazarene and Lynnon, the endpoint of Nazarene. This cartridge and nose thickness determination logic using Nacion and Linion will be described with reference to FIG. Depending on the CT device or imaging protocol, the same organization may represent different Hounsfield unit values and the user may need to determine the appropriate unit of skin volume for the bone or skin to increase the accuracy of patient diagnosis using CT data from the patient . The left image of FIG. 1 is an image when the Hounsfield unit value is 525 HU, and the right image is an image when -200 HU. The Hounsfield unit value is defined as Hounslow unit (HU) 0, which is obtained by linearly converting the radiation density in the distilled water of the standard pressure STP condition to the original linear attenuation coefficient. Table 1 below shows Seeram, E. Computed Tomography-Physical Principles, Clinical Applications, and Quality Control. Pennsylvania: W.B. Saunders Co .; It is the Hounsfield unit value given in 1994.

Tissue CT Number (HU) Bone +1000 Liver 40 to 60 White mater -20 ~ -30 Gray matter -37 to -45 Blood 40 Muscle 10 to 40 Kidney 30 CSF 15 Water 0 Fat -50 ~ -100 Air -1000

As a result, the hornsfield unit value of the bone can be generally 400 to 3000 HU. In particular, when referring to the 'exact matching method of three-dimensional face scan data and CBCT data using distance map', Lee et al. It may be difficult to determine, but it may range from -1024HU to -670HU, which can be estimated as air shaded by inversely estimating that the air shadow is in contact with the boundary of the skin data. Figure 3 is a stereoscopic image in which a cartridge implemented from the displayed Nacion and Linion is implemented. The cartridges are cartilage tissue of the patient from the Nacion and Lignon values. The distance from the bone to cartilage to the skin can be estimated from the height value of the red line displayed on the sectional image of the stereoscopic image of FIG.

FIG. 4 shows a region of interest of a stereoscopic image implemented by a patient. Of the patient's facial stereoscopic images, the region of interest directly associated with the nasal prosthesis may be the steric region shown in Fig. The region of interest may be 10 to 40 mm to the right and left of the nacrite, 0.1 to 30 mm back, 0.1 to 20 mm above the nacion, and 0.1 to 40 mm below the linen. Preferably 30 mm to the right and left of the nacelle, 25 mm to the back, 15 mm above the nacion, and 35 mm below the liner. More preferably, it may be 20 mm to the right and left of the nacrite, 20 mm to the back, 10 mm to the top of the nacion, and 30 mm to the bottom of the liner. It is obvious that such an area of interest can be appropriately changed according to the shape of the patient according to various races, sexes, ages and the like.

As shown in FIG. 5, in the case of an image of a three-dimensional skin image of a patient, in one embodiment, an image information capacity of about 182 megabytes is required to implement the entire image, , The image information capacity for image processing is 2.86 megabytes, and the processing speed is about 64 times faster, so that the speed of implementation of the stereoscopic image of the patient is remarkably accelerated drastically.

6 is a stereoscopic image image in which the stereoscopic image information of the region of interest is implemented in the main image information of the patient. In this embodiment, the image information capacity of about 147 megabytes is required in order to fully implement the main image information of the patient. However, when the image information is implemented only in the portion set as the region of interest, the image information capacity of about 5.24 megabytes And the processing speed for implementing the image information is about 28 times faster. This implementation dramatically speeds up the presentation of image information to the patient in a short period of time for the patient's nasal implants. The increase in the processing speed differs depending on the image information of the patient, but the improvement of the processing speed is obvious. Table 2 shows the capacity of the image information when the skin and the original stereoscopic image of the bone and the original image are limited to the region of interest.

Original (When using CT images with a thickness of 1 mm or less) After processing Skin 50 mega ~ 1 gigabyte 1 to 50 mega Bone 50 mega ~ 1 gigabyte 1 to 50 mega

Also, the region of interest may be three-dimensional shape information realized by recognizing two points where the curvature value of the nose changes. Such an implementation may be possible by selectively implementing one or more of stereoscopic image information of the patient, an enteral, a lateral, and a warm view. Extract skin curves from the center plane of the lateral view and implement the logic to find two points where the tangent of the tangent of the curve is vertical, and to determine the lower point as a subnase. Or to find the two points where the change of the curvature value changes globally to the lower side of the NAGOON, and implement the logic to determine the upper point of the curvature and the lower point of the subnormal. The method by which the two points can be determined mathematically is not limited to this. An embodiment implementing the above information is shown in Fig .

Fig. 8 is a stereoscopic image image for determining the thickness of the nasal prosthesis. In the above image, the extension line connecting the nacion with the blue dot and the linion indicated by the blue dot, and the contact point of the foremost part of the skin are shown in green, and the advantage is recognized as a nibble. Calculate the shortest distance between Nashion and Nazareth as the length of the nose and measure the thickness from the Nashon and Nazareth points to the vertical view of the extension line and from the cartridge to the skin. Based on these measurements, a nasal prosthesis that fits the nose of the patient is selected. The thickness of the selected nasal prosthesis is measured and implemented in the patient's stereoscopic image information. It is possible to omit the process of adjusting the thickness by carving the actual implant during the surgery using the actual implant and marking the thickness value of the portion having the thickness of the mexican between Nacion and Nazareth. You can try to simulate it.

9 is a stereoscopic image image in which a linion is set as an embodiment. In this case, the curve viewed from the center plane of the lateral view is extracted, and the first point where the change of the curvature value is changed globally downward is set as Lignon. The point indicated by the red circle is the point at which the linion is set.

FIG. 10 is an image showing cross-sectional information of a stereoscopic image for minimizing skew and skew error of a bone. When matching the nasal implant to the actual nasal configuration of the patient, when the patient's stereoscopic image information is grasped as a warm view, there is an error in the lateral portion. In order to minimize the error, an algorithm was developed to minimize the lateral deviation using the left and right skins of the patient and the interval between the bones. Blue in FIG. 10 is defined as a normal vector of a lateral view, red is defined as a normal vector of an anterior view, and image information of a skin is matched with respect to a linion point. At this point, the point 3 mm below is defined as pt1. The points +25 mm and -25 mm in the normal vector direction of the lateral view are defined as pt2 and pt3, respectively, based on pt1. Define the intersections of the skins for defined pt1, pt2, and pt3 as pts1 and pts2, respectively. For the defined pt1, pt2 and pt3, the intersections of the bones are defined as ptb1 and ptb2, respectively. Then, the scale factor values are expressed by the following formulas using the values of pts1, pts2, ptb1, and ptb2. And corrects the side portion error from the scale factor value calculated from the next-defined scale factor expression. Scaling factor (Side) = (pt1-ptb2) / (pt1-pts2) / (pt1-pt1)

Typically, if Nasion and / or Rhinion is selected in the CT data, the process of calculating the region of interest and automatically combining the bones and skins to display the Cartilage is performed. A step of automatically measuring the nose length and / or thickness using the data of the cartridge and loading the implant in the implant library can be performed. If the cartridge is displayed on the patient's image data through the above steps, the nose length and / or thickness of the patient are automatically measured through the bone and cartridge data and the predetermined implant is loaded into the patient's image data from the implant library. A technical feature of the present invention is to implement a cartridge of a patient from the image data of the patient embodied in the step. The patient's image data is recognized as a nasal tip of the extension line connecting the nano-on-liner and the contact point of the foremost part of the skin. In the nano- The thickness of the portion with the maximal thickness between the najing and the nail tip is also displayed so that the process of adjusting the thickness by carving the actual implant during surgery can be omitted , You can easily simulate before surgery.

Also, if the patient is identified as an existing patient in the above step, the previous project file can be loaded and moved to the step in progress. By loading the project file, the time required during the diagnosis process of the patient can be shortened and the cost for diagnosis of the patient can be reduced. In addition, an implant, a lateral view, or a worms view may be displayed according to the position adjustment of the implant in the above step, and a prosthesis according to a predetermined value of the nose fusion ratio may be displayed in the stereoscopic view.

In addition, the stored implant preparation information may further include a step of preparing the implant or implanting the implant using 3D printing through transmission.

In addition, the selection of the CT data in the above step may display CT image data of any one of Horizontal, Coronal, and Sagittal images of the CT data. When reconstructing a 3D image without selecting an image, CT reconstruction may be incorrectly reconstructed or an error may occur. This is because, depending on the method of the CT production company or the hospital in charge, the protocol information or other information may be mixed in the middle of the CT scan. Therefore, it is possible to distinguish the entire CT data of one patient by each image type, to distinguish other information inserted in the middle, and reconstruct a three-dimensional image selectively, thereby realizing a three-dimensional image with accurate image information. While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art in light of the above teachings. It is to be understood that such modified embodiments are also within the scope of protection of the present invention as defined by the appended claims.

Claims

A method of making a patient-customized nasal implant,
A first step of acquiring a stereoscopic image through volume rendering using a medical diagnostic apparatus on a face of a patient;
A second step of displaying a reference point of two points or less in the face image of the patient; And
And a third step of implementing a cartilage stereoscopic image of the nose using the skin and image information of the bone from the displayed reference point
Wherein when the reference point of the second step is one point, the nacion is displayed and the other point is automatically displayed from the patient's face stereoscopic information.

The method according to claim 1,
Further comprising the step of determining the stereoscopic image information of the region of interest among the stereoscopic images as an image to reduce data loading time.

3. The method of claim 2,
Wherein the region of interest is three-dimensional shape information of 10 to 40 mm on the right and left sides of the nacrite, 0.1 to 30 mm on the back, 0.1 to 20 mm on the upper side of the nacillis, and 0.1 to 40 mm on the lower side of the linnion.

3. The method of claim 2,
Wherein the region of interest is three-dimensional shape information that extracts a skin curve from a center plane of a letter view of a stereoscopic image and recognizes and realizes two points where the slope of the tangent line is vertical.

The method according to claim 1,
Wherein when the reference point of the second step is two points, the reference point is a nacion and a lignion.

delete

The method according to claim 1,
Wherein the patient's face stereoscopic information is Lignon.

The method according to claim 1,
Wherein the cartridge stereoscopic shape of the third step is a cartilage stereoscopic image of the nose by moving the skin stereoscopic information to the stereoscopic information by the distance between the skin and the main body of the patient based on the boundary between the main body and the cartridge A method of making a patient-customized nasal implant.

9. The method of claim 8,
Wherein the boundary between the bone and the cartridge is a lineion.

10. The method of claim 9,
Wherein the cartridge solid shape in the third step uses an algorithm that minimizes a side portion error using the interval between the right and left skins of the patient and the bone on the basis of the cross section of the linone.

The method according to claim 1,
Wherein the cartilage three-dimensional shape of the third step derives the cartilage three-dimensional shape of the nose using the correlation between the skin, the mucous membrane, the cartridge and the bone in the collected patient DB.

The method according to claim 1,
And selecting the implant from the library of one or more implants on a three-dimensional rendered nose stereoscopic image to produce patient-specific nasal prosthesis stereoscopic information.

13. The method of claim 12,
And a step of fabricating a patient-customized nasal prosthesis using a processing device capable of applying the manufactured patient-customized nasal implant stereoscopic information.