KR20250177689A - Patient-customized spine fixation system and method using AI - Google Patents

Abstract

The present invention relates to a patient-tailored spinal fixation system and method using artificial intelligence, comprising: a pedicle screw inserted and fixed into a vertebral body above and below a damaged disc; a rod for connecting two or more pedicle screws by being seated in a receiving groove of the pedicle screw; and a screw fastened to the receiving groove of the pedicle screw and pressurizing the rod to prevent it from moving. The rod analyzes medical image data and patient information acquired before surgery using artificial intelligence, derives rod bending data for correction based on the analyzed data information, and directly outputs the derived rod bending data using metal 3D printing, thereby enabling the rod to be manufactured and applied in a patient-tailored manner, and overcomes problems such as infection in the operating room.

Description

Patient-customized spine fixation system and method using AI

The present invention relates to a patient-tailored spinal fixation system and method using artificial intelligence, and more specifically, to a spinal fixation system and method that analyzes medical image data such as X-ray or computed tomography (CT) and patient information using artificial intelligence, derives rod bending data for correction, and directly outputs the derived data using metal 3D printing so that it can be applied in a patient-tailored manner.

The spine is the vertical axis of the body and is composed of seven cervical vertebrae, twelve thoracic vertebrae, five lumbar vertebrae, five sacrum vertebrae, and four coccyx vertebrae, and intervertebral discs, which are disc-shaped cartilaginous structures that connect the vertebrae to each other.

The spine can develop various diseases due to various causes. Diseases that cause spinal instability include scoliosis, lordosis (kyphosis), spinal dislocation, fracture, and spondylolysis.

At this time, the surgery to correct spinal disease and fix the bones that have caused instability is called spinal fixation.

Spinal fusion is a surgical procedure that connects two or more adjacent vertebrae into one, and is a widely used surgical method to solve spinal diseases. The spinal device used here is a pedicle screw system.

Typically, a pedicle screw system includes a pedicle screw that is inserted and fixed into the vertebral body above and below the damaged disc, a rod that connects and fixes the pedicle screw, and a screw that is fastened onto the fixed pedicle screw and rod to correct the spine.

The above rod acts as a support to hold the spine in place when combined with a pedicle screw during spinal fusion surgery, thereby ensuring smooth intervertebral fusion.

Figures 1 to 4 are drawings sequentially showing a surgical method using an existing pedicle screw system.

In order to perform surgery using this existing pedicle screw system, a surgical plan is first established using medical image data (X-ray, CT, etc.), the size and direction of the screw for each segment (level) to be corrected are determined (Fig. 1), and the selected screw is fixed for each segment (Fig. 2).

Afterwards, the rod is bent using a surgical instrument (Fig. 3).

At this time, the load bending operation is performed manually in the operating room, bending the load to correspond to the position of the screw so that the screws fixed in each segment can be connected.

Afterwards, a bent rod is inserted into the fixed screw portion, and each segment is corrected using a set screw on the fixed screw and rod (Fig. 4).

However, because the human spine must be considered and corrected in three dimensions, performing spinal surgery using the existing pedicle screw system was very complicated and difficult to do naturally.

Additionally, since the level of satisfaction with the surgery is determined by the doctor's clinical skills, it can be difficult for some patients to achieve aesthetic satisfaction.

Additionally, by using the rod after bending it, fatigue failure occurs due to continuous bending, and breakage of the rod is observed after surgery.

In addition, because the load bending work is performed manually in the operating room, it is vulnerable to infection, which can lead to reoperations, and a solution to this has been required.

Korean Patent No. 10-0645377

The present invention has been devised to solve the above problems, and the purpose of the present invention is to provide a patient-tailored spinal fixation system and method that analyzes medical image data such as X-ray or computed tomography (CT) images and patient information using artificial intelligence before surgery, without performing rod bending work manually in an operating room, derives rod bending data for correction, and directly outputs the derived data using metal 3D printing so that it can be applied in a patient-tailored manner.

In order to achieve the above purpose, the present invention provides a patient-tailored spinal fixation system, which comprises a pedicle screw inserted and fixed into a vertebral body above and below a damaged disc, a rod for connecting two or more pedicle screws by being seated in a receiving groove of the pedicle screw, and a screw for connecting the rod to the receiving groove of the pedicle screw and pressurizing the rod to prevent it from moving, wherein the rod analyzes medical image data and patient information acquired before surgery using artificial intelligence, derives rod bending data for correction based on the analyzed data information, and is manufactured by directly outputting the derived rod bending data using metal 3D printing.

The above medical image data is an X-ray or computed tomography (CT) image before surgery, and the patient's information is characterized by at least one selected from among gender, height, weight, and age.

The above-described rod in the present invention may be formed into a three-dimensional shape that is lordotic, kyphotic, scoliotic, or a mixture of two or more thereof, depending on the curvature of the spine.

Meanwhile, the above load may have a cross-section that is formed of one or a combination of circular, square, train rail, and polygonal shapes.

Additionally, the above load may have a protrusion formed at the joint where it is combined with the spinal screw to prevent slipping and increase fixing force.

In addition, the load may have a direction indicator mark formed on the top, bottom, or side of the load to determine the direction in which it is coupled to the spinal screw.

The above load can be manufactured by measuring appropriate strength through finite element analysis by linking medical image data and patient information, and varying the thickness of the joint with the pedicle screw and the area excluding the joint in the longitudinal direction of the load to suit the patient.

Meanwhile, as a method for achieving the above-described object of the present invention, a patient-tailored spinal fixation method is provided, including the steps of obtaining medical image data on a damaged spine through an X-ray or computed tomography (CT) before surgery, the step of inputting information on at least one selected from the group consisting of the patient's gender, height, weight, and age, the step of analyzing the medical image data and the patient's information using artificial intelligence, the step of deriving rod bending data for correction based on the analyzed data information, the step of outputting a rod by metal 3D printing using the derived rod bending data, and the step of applying the bent rod output by 3D printing to the patient.

The step of analyzing the above medical image data and patient information using artificial intelligence is characterized by measuring an appropriate strength by linking finite element analysis using the above medical image data and patient information, and varying the thickness of the load according to the patient.

According to the present invention as described above, rather than performing the rod bending work manually in the operating room, the medical image data such as X-ray or computed tomography (CT) images before surgery and the patient's information are analyzed using artificial intelligence, and the rod bending data for correction is derived, and the derived data is directly output through metal 3D printing, thereby having the effect of being able to be applied in a patient-tailored manner.

Additionally, since no load bending is performed during surgery, fatigue failure due to load bending can be prevented, and problems such as infection in the operating room can be overcome.

Additionally, it is possible to perform the surgery in a planned manner and has the effect of shortening the surgery time compared to conventional spinal fixation.

Figures 1 to 4 are drawings sequentially showing a surgical method using an existing pedicle screw system.
FIG. 5 is a perspective view illustrating a first embodiment of a rod in a patient-specific spinal fixation system according to the present invention.
FIGS. 6 to 10 are perspective views illustrating other embodiments of a rod in a patient-specific spinal fixation system according to the present invention.
Figure 11 is a flowchart illustrating a patient-specific spinal fixation method according to the present invention.

The advantages and features of the present invention, and the methods for achieving them, will become clearer with reference to the embodiments described in detail below together with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but may be implemented in various different forms. These embodiments are provided solely to ensure that the disclosure of the present invention is complete and to fully inform those skilled in the art of the scope of the invention, and the present invention is defined only by the scope of the claims. Like reference numerals designate like elements throughout the specification.

FIG. 5 is a perspective view illustrating a first embodiment of a rod in a patient-specific spinal fixation system according to the present invention.

The patient-tailored spinal fixation system according to the present invention comprises a pedicle screw (not shown) inserted and fixed into the vertebral body above and below a damaged disc, a rod (100) seated in a receiving groove of the pedicle screw to connect two or more pedicle screws, and a screw (not shown) fastened to the receiving groove of the pedicle screw and pressurized to prevent the rod from moving.

The above load (100) has the characteristic of being applied in a patient-specific manner by being directly printed using metal 3D printing to fit the patient's spine before surgery.

That is, the present invention is to solve the problems of the prior art by enabling spinal fixation surgery to be performed using a rod (100) that is custom-made for the patient based on information about the patient's damaged spine before surgery, without manually performing rod bending work in an operating room.

To this end, the above-mentioned load (100) is characterized by analyzing medical image data such as preoperative X-ray or computed tomography (CT) images and patient information using artificial intelligence, deriving rod bending data for correction, and directly outputting the derived data through metal 3D printing, thereby applying it in a patient-specific manner.

The above medical image data may consist of either preoperative X-ray or computed tomography (CT) images.

Typically, in order to perform surgery using a pedicle screw system, the damaged spine is first identified using medical image data (X-ray, CT), and the size and direction of the screws for each level to be corrected are determined to establish a surgical plan. Therefore, in the present invention, medical image data on the damaged spine is also obtained using X-ray or computed tomography (CT).

However, the present invention is not limited thereto, and any technical means capable of obtaining medical image data on a patient's damaged spine other than the X-ray or computed tomography (CT) may be included.

Meanwhile, in the present invention, the patient's information, such as the patient's gender, height, weight, age, etc., is used together with the medical image data as data for producing the load (100).

In this way, the rod (100) of the present invention can be manufactured by obtaining medical image data such as X-ray or computed tomography (CT) images and patient information before surgery, analyzing the data using artificial intelligence to derive rod bending data for correction, and directly outputting the rod using metal 3D printing using the derived data.

The above rod (100) may be formed of a metal. For example, the rod (100) may be formed of at least one material selected from the group consisting of a titanium alloy (Gr23), a Ti-Ni alloy, stainless steel, a shape memory polymer, and a Co-Cr-Mo alloy.

When the above-mentioned rod (100) is manufactured using a 3D printer, a method of melting a metal material and then laminating and attaching the metal material using an additive manufacturing method that is identical to the derived rod bending data can be performed.

As shown in Fig. 5, such a rod (100) may be formed into a cylindrical shape. This cylindrical shape is identical to the shape of a general rod, and in the present invention, in order to improve the strength, fixing force, etc. of the rod, it is possible to have various cross-sectional shapes in addition to the cylindrical shape.

FIGS. 6 to 10 are perspective views illustrating other embodiments of a rod in a patient-specific spinal fixation system according to the present invention.

As shown in Fig. 6, the load may have a cross-section in the shape of a train rail (a), a square (b), etc., and may be formed of one or a combination of polygonal shapes such as a pentagon or a hexagon.

In addition, the above load may be composed of a joint portion, which is a portion that is connected to the spinal screw, and a support portion excluding the joint portion.

That is, in order to perform surgery using a rod output by metal 3D printing through rod bending data, the exact position where the rod is combined with the pedicle screw for each level to be corrected must be identified. Therefore, the rod in the present invention is composed of the above-described connecting portion and the supporting portion, and the position of the connecting portion must be indicated on the rod.

Accordingly, a display unit that displays the above-mentioned joint on the load may be provided separately.

The above display unit can be configured to be displayed as a kind of mark, and the positions of the pedicle screws for each segment (level) to be corrected can be displayed in order, or the display unit can be configured using various structures.

For example, the number of each segment (level) to be corrected can be engraved in intaglio or relief, and shapes such as dots, arrows, and triangles can be engraved in intaglio or relief on the rod so that it can be combined with a pedicle screw in an accurate location during surgery.

As the above-mentioned display part, as shown in Fig. 7, a protrusion (112) may be formed on the joint part that is combined with the spinal screw to prevent slipping and increase fixing force.

The above-mentioned protrusion (112) indicates the position where the joint is joined with the pedicle screw, and has the function of preventing slippage and increasing the fixing force when joined with the pedicle screw.

Meanwhile, the rod in the present invention may be formed into a three-dimensional shape that is a combination of lordosis, kyphosis, scoliosis, or two or more thereof depending on the curvature of the spine.

Therefore, in order to apply this type of rod to spinal fixation, it is very important to attach the rod to the pedicle screw in the correct direction.

To this end, the load in the present invention may have a direction indicator mark (212) formed on the top, bottom, or side of the load to confirm the direction in which it is coupled to the spinal screw, as shown in FIG. 8.

The above direction indicator mark (212) may be a line formed in the longitudinal direction of the load, and may also be formed in various other shapes.

By forming these direction indicator marks (212) on the top, bottom, or side of the rod (210), the surgeon can hold the rod (210) in the correct direction and connect it to the pedicle screw during surgery.

Meanwhile, as shown in Fig. 9, the above-mentioned rods (310) can be used by connecting two, three, or four rods, taking strength into consideration. In this case, a rod connection port (312) may be further included so that multiple rods (310) can be used.

In the present invention, the rod can be manufactured by measuring an appropriate strength by linking finite element analysis using medical image data and patient information, and varying the thickness of the joint portion with the pedicle screw and the portion excluding the joint portion, i.e. the support portion, in the longitudinal direction of the rod to suit the patient.

FIG. 10 is a perspective view illustrating an embodiment in which the connecting portion (412) and the supporting portion (414) are formed. The rod (410) may include a supporting portion (414) having a diameter or shape different from that of the connecting portion (412) to serve as a support for holding the spine.

The above support portion (414) may be formed of two or more plurality of pieces, and in this case, each support portion (414) may be formed to have a different diameter or shape. That is, as shown in FIG. 10, the support portion may be formed of two or more plurality of pieces, including a first support portion and a second support portion, and the second support portion, which is formed at a position where it is necessary to support the spine with higher strength, may be formed to have a larger diameter by increasing its diameter.

At this time, the shape of the first support or the second support may be formed in a shape other than the cylindrical rod shape illustrated in Fig. 10.

Figure 11 is a flow chart illustrating a patient-tailored spinal fixation method according to the present invention. The spinal fixation method using the spinal fixation system of the present invention having the above configuration is as follows.

First, medical image data on the damaged spine is acquired through X-ray or computed tomography (CT) before surgery (S110).

Additionally, one or more pieces of information selected from the patient's gender, height, weight, and age are entered (S120). Here, the patient's information can be entered into an artificial intelligence analysis program, etc.

The above medical image data and patient information are analyzed using artificial intelligence (S130).

Afterwards, rod bending data for correction is derived based on the analyzed data information (S140).

Here, by linking the above medical image data and patient information with finite element analysis, the appropriate strength can be measured and the thickness of the load can be varied to suit the patient.

Using the derived load bending data, a load is output by metal 3D printing, and the bent load output by 3D printing is applied to the patient and used during surgery.

According to the present invention as described above, rather than performing the rod bending work manually in the operating room, the medical image data such as X-ray or computed tomography (CT) images before surgery and the patient's information are analyzed using artificial intelligence, and the rod bending data for correction is derived, and the derived data is directly output through metal 3D printing, thereby having the effect of being able to be applied in a patient-tailored manner.

In addition, since no rod bending is performed during surgery, fatigue failure due to rod bending can be prevented, and problems such as infection in the operating room can be overcome.

Additionally, it is possible to perform the surgery in a planned manner and has the effect of shortening the surgery time compared to conventional spinal fixation.

While the above description focuses on specific embodiments of the present invention, those skilled in the art will appreciate that various modifications and variations can be made. Such modifications and variations, as long as they do not depart from the scope of the technical concept provided by the present invention, are considered to be within the scope of the present invention. Therefore, the scope of the present invention should be determined by the claims set forth below.

100: Road 112: Rough
212: Directional Mark 312: Load Connector
412: Joint 414: Support

Claims (9)

Pedicle screws inserted and fixed into the vertebral bodies above and below the damaged disc;
A rod for connecting two or more pedicle screws by being seated in the receiving groove of the pedicle screw; and
A screw that is fastened to the receiving groove of the above-mentioned pedicle screw and pressurizes the load to prevent it from flowing;
Includes,
The above load is a patient-tailored spinal fixation system characterized in that it analyzes medical image data and patient information obtained before surgery using artificial intelligence, derives rod bending data for correction based on the analyzed data information, and directly outputs the derived rod bending data using metal 3D printing. In claim 1,
The above medical image data is an X-ray or computed tomography (CT) image before surgery.
A patient-tailored spinal fixation system characterized in that the patient's information includes at least one selected from among gender, height, weight, and age. In claim 1,
The above-mentioned rod is a patient-customized spinal fixation system characterized by having a three-dimensional shape that is lordotic, kyphotic, scoliotic, or a mixture of two or more of these depending on the curvature of the spine. In claim 1,
A patient-tailored spinal fixation system characterized in that the above load has a cross-section formed of one or a combination of circular, square, train rail, and polygonal shapes. In claim 1,
A patient-tailored spinal fixation system characterized in that the above load has a protrusion formed on the joint where it is connected to the spinal screw to prevent slippage and increase fixation force. In claim 1,
A patient-tailored spinal fixation system characterized in that a direction indicator mark is formed on the top, bottom, or side of the rod to confirm the direction in which the rod is connected to the pedicle screw. In claim 1,
The above load measures the appropriate strength by linking finite element analysis with medical image data and patient information, and
A patient-tailored spinal fixation system characterized in that the thickness of the connection portion with the above-mentioned pedicle screw and the area excluding the connection portion are manufactured in a longitudinal direction of the rod to suit the patient. A step of acquiring medical imaging data on the damaged spine through X-ray or computed tomography (CT) before surgery;
A step of entering one or more pieces of information selected from the patient's gender, height, weight, and age;
A step of analyzing the above medical image data and patient information using artificial intelligence;
A step of deriving rod bending data for correction based on the analyzed data information;
A step of outputting a load using metal 3D printing using the derived load bending data; and
Step of applying the bent rod output by 3D printing to the patient;
A patient-tailored spinal fixation method including: In claim 8,
The step of analyzing the above medical image data and patient information using artificial intelligence is:
A patient-tailored spinal fixation method characterized by measuring appropriate strength by linking finite element analysis with the above medical image data and patient information and varying the thickness of the load to suit the patient.