Patient-bone-customized cervical vertebra fixing plate using 3D printing technology

A 3D-printed cervical spine fixing plate with a screw departure blocking mechanism and porous structure addresses the instability issues of conventional plates by enhancing adhesion and preventing screw loosening, ensuring strong and stable fixation.

WO2025023347A1PCT designated stage expired Publication Date: 2025-01-30ACE MEDICORP CO LTD

Patent Information

Application Number
PCT/KR2023/010858
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-07-26
Filing Date
2023-07-26
Publication Date
2025-01-30

AI Technical Summary

Technical Problem

Conventional cervical spine fixing plates face challenges such as slippery surfaces during surgery, screw loosening due to repetitive bone movement, and weakened adhesive bonding between the plate and bone, leading to instability and reduced fixation strength.

Method used

A patient-specific cervical fixing plate manufactured using 3D printing technology with a screw departure blocking plate and a porous structure layer to enhance adhesion and prevent screw loosening, featuring an elliptical plate structure with a locking mechanism and non-slip surface to ensure secure fixation.

Benefits of technology

The solution provides a strong and stable fixation of the cervical spine, improves bone fusion, and reduces the risk of screw displacement and loosening, ensuring long-term stability and adhesion between the plate and bone.

✦ Generated by Eureka AI based on patent content.

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Abstract

The objective of the present invention is to provide a patient-bone-customized cervical vertebra fixing plate using 3D printing technology, the cervical vertebra fixing plate having a screw separation blocking plate rotatably formed thereon so as to prevent the pushing outward of a screw inserted into and fastened to the cervical vertebra from the cervical vertebra fixing plate such that the fixing state of the cervical vertebra fixing plate can be firmly maintained, and also having an uneven part or a porous structure layer for improving adhesion to the cervical vertebrae so that the cervical vertebra fixing plate can be firmly adhered, without deviation from the position thereof, to the cervical vertebrae between which an artificial disc is inserted, and enabling adhesion and coupling force between the inner surface of the cervical vertebra fixing plate and the surface of the cervical vertebra to be improved.
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Description

Patient-specific cervical spine fixation plate using 3D printing technology

[0001] The present invention relates to a patient-specific cervical fixation plate using 3D printing technology, and more particularly, to a patient-specific cervical fixation plate using 3D printing technology that can connect and fix cervical vertebrae to each other.

[0002] The spine of the human body includes the cervical vertebrae that make up the neck, the thoracic vertebrae that make up the back, and the lumbar vertebrae that make up the waist. Between each vertebra is an intervertebral disc, commonly called a disk. This intervertebral disc supports the movement of the spine between the adjacent vertebrae above and below, and also plays a role in absorbing and alleviating shock.

[0003] Among the methods for treating herniated disc in the cervical spine, a surgical treatment method is performed in which the damaged disc between the cervical vertebrae is removed, an artificial disc is filled in the removed space, and the cervical vertebrae are fixed so that they do not move with a cervical fixation plate.

[0004] The above cervical fixation plate protects the newly filled artificial disc between the cervical vertebrae to prevent it from dislodging, and also connects the cervical vertebrae above the artificial disc to the cervical vertebrae below the artificial disc to fix them in place so that they do not move.

[0005] The attached drawings 1 and 2 are front and side views illustrating a conventional cervical fixation plate.

[0006] As shown in FIGS. 1 and 2, the existing cervical fixation plate (10) is manufactured as a plate structure in which a plurality of fastening holes (12) are formed.

[0007] Accordingly, the existing cervical fixation plate (10) can be fixed through a process of attaching the cervical fixation plate (10) to the cervical vertebra (200) into which the artificial disc (210) is inserted and the cervical vertebra (200), and a process of inserting and fixing a screw (14) to the cervical vertebra (200) through a fixing hole (12) formed in the cervical fixation plate (10).

[0008] In addition, the cervical fixation plate (10) must be maintained in a fixed state, connecting the cervical vertebrae (200) to the cervical vertebrae (200) for a set period of time until the artificial disc (210) is firmly established.

[0009] However, conventional cervical fixation plates have the following problems.

[0010] First, when the existing cervical fixation plate (10) is pressed against the surface of the cervical vertebra (200) into which the artificial disc (210) is inserted, the cervical fixation plate (10) easily slips from its original position as it slides on the surface of the cervical vertebra (200) which has a slippery surface, making it difficult to fix the cervical fixation plate (10) in its original position during surgery.

[0011] Second, the cervical fixation plate (10) can be fixed by inserting and fixing a screw (14) to the cervical vertebra (200) through a fixing hole (12) formed in the existing cervical fixation plate (10). However, due to the repetitive movement of the cervical vertebrae according to the behavior of the patient discharged from the hospital after surgery, the fixing force of the screw (14) decreases, and the screw (14) is pushed outward from the cervical vertebrae (200) and the cervical fixation plate (10). As a result, after a certain period of time, the fixation state of the existing cervical fixation plate (10) becomes loose, which may result in a deterioration in the patient's cervical surgery outcome.

[0012] Third, the cervical fixation plate (10) can be fixed by inserting and fixing a screw (14) into the cervical vertebra (200) through a fixing hole (12) formed in the existing cervical fixation plate (10). However, after the surgery, the bone adheres only to the screw (14) inserted into the cervical vertebra, and the bone does not adhere to the smooth inner surface of the cervical fixation plate (10). As a result, the adhesive bonding force between the inner surface of the cervical fixation plate (10) and the surface of the cervical vertebra (200) is weakened, resulting in a problem in that the fixing force of the cervical fixation plate (10) is reduced.

[0013] The present invention has been devised to solve the above-mentioned problems of the related art, and its main purpose is to provide a patient-specific cervical fixation plate using 3D printing technology, which prevents a screw inserted into a cervical vertebra from being pushed outward by forming a screw detachment blocking plate rotatably on a cervical fixation plate, thereby maintaining the fixation state of the cervical fixation plate firmly.

[0014] In addition, the present invention provides a patient-specific cervical fixation plate using 3D printing technology that forms a concave portion or a porous structural layer on the cervical fixation plate to improve adhesion with the cervical vertebrae, so that the cervical fixation plate can be firmly adhered to the cervical vertebrae into which the artificial disc is inserted without being displaced from its original position, and improve the adhesion between the inner surface of the cervical fixation plate and the surface of the cervical vertebrae.

[0015] In order to achieve the above object, the present invention provides a cervical fixation plate customized to a patient's bone using 3D printing technology, comprising: a fixation plate manufactured by 3D printing based on a patient's spinal imaging data, wherein a plurality of screw fastening holes are formed at predetermined positions at all four corners, and an artificial disc observation window is formed through a central region, so as to be tightly fixed to a cervical vertebra; and a screw detachment blocking plate having an oval plate structure in which a locking plate is protruded on one side and a wrench groove is formed on the other side, and is rotatably fastened at a position adjacent to the screw fastening hole on the upper surface of the fixation plate; and after the screw is fastened to the cervical vertebra through the screw fastening hole, a rotating tool is inserted into the wrench groove to rotate the screw detachment blocking plate toward the screw, so that the locking plate is placed over the head of the screw to prevent the screw from detaching.

[0016] In addition, it is characterized in that a space is formed on the upper surface of the fixed plate body in which the screw detachment blocking plate is inserted and fixed at a position adjacent to the screw fastening hole, and a fixing groove is formed to guide the rotational trajectory of the screw detachment blocking plate at a constant level.

[0017] In addition, the fixing plate body is characterized in that a slide groove having a first locking groove and a second locking groove at each end is formed in the fixing groove portion, and a locking projection is formed at the bottom of the screw release blocking plate to move along the slide groove and be locked and inserted into the first locking groove or the second locking groove.

[0018] In addition, the lower surface of the fixed plate is characterized by having a non-slip groove formed thereon to prevent slipping when in contact with the cervical vertebrae.

[0019] In addition, the lower surface of the fixed plate is characterized by having a porous structural layer formed thereon to prevent slippage when in contact with the cervical vertebrae and to induce bone fusion with the cervical vertebrae.

[0020] Through the means for solving the above-mentioned problem, the present invention provides the following effects.

[0021] First, by forming a screw detachment blocking plate rotatably on the cervical fixation plate, the screw inserted into the cervical vertebra from the cervical fixation plate can be prevented from being pushed outward, and the fixation state of the cervical fixation plate can be maintained firmly even when the cervical vertebra is repeatedly moved according to the patient's movements after discharge from the hospital.

[0022] Second, by forming a roughened portion or a porous structure layer on the lower surface of the cervical fixation plate, the cervical fixation plate can be firmly attached to the cervical vertebrae into which the artificial disc is inserted without being displaced from the original position, and the bone fusion between the inner surface of the cervical fixation plate and the surface of the cervical vertebrae can be easily induced, thereby improving the bonding strength of the cervical fixation plate.

[0023] Third, by manufacturing the cervical fixation plate using 3D printing based on the patient's spinal imaging data (MRI or CT scan data), we can provide a patient-specific cervical fixation plate that fits the patient's cervical surgery site perfectly, and also, since the cervical fixation plate can be tightly fixed to the patient's cervical surgery site perfectly, the foreign body sensation caused by the cervical fixation plate can be eliminated after surgery, thereby improving the patient's satisfaction with the cervical surgery.

[0024] Figure 1 is a front view showing the fixation state of a conventional cervical fixation plate.

[0025] Figure 2 is a side view showing the fixation state of a conventional cervical fixation plate.

[0026] Figures 3a and 3b are isometric views illustrating a patient-specific cervical spine fixation plate using 3D printing technology according to the present invention.

[0027] Figure 4 is a front view showing the assembled state of the patient-specific cervical fixation plate using the 3D printing technology according to the present invention, with the screw detachment blocking plate in a state before locking.

[0028] Figure 5 is a front view showing a patient-specific cervical fixation plate using 3D printing technology according to the present invention being fastened to the cervical vertebrae with screws and a screw detachment blocking plate being placed in a state before being locked.

[0029] Figure 6 is a front view showing a patient-specific cervical fixation plate using 3D printing technology according to the present invention, which is fixed to the cervical vertebrae with a screw, and then the screw detachment blocking plate is rotated to the screw locking position to lock the screw.

[0030] Figures 7 and 8 are perspective views of a patient-specific cervical spine fixation plate using 3D printing technology according to the present invention, viewed from below.

[0031] Hereinafter, a preferred embodiment of the present invention will be described in detail with reference to the attached drawings.

[0032] The attached drawings 3a and 3b are exploded perspective views illustrating a patient-specific cervical fixation plate using a 3D printing technology according to the present invention, and FIG. 4 is a front view illustrating an assembled state of a patient-specific cervical fixation plate using a 3D printing technology according to the present invention, with a screw detachment blocking plate placed in a state before being locked. In each drawing, reference numeral 100 indicates a cervical fixation plate according to the present invention.

[0033] The cervical fixation plate (100) according to the present invention is manufactured by 3D printing with titanium material based on the patient's spinal imaging data (e.g., MRI or CT imaging data) so as to prevent the newly filled artificial disc between the cervical vertebrae from being dislodged, and at the same time, to ensure that the cervical vertebrae above the artificial disc and the cervical vertebrae below the artificial disc are connected and fixed without movement, so that it can be manufactured in a patient-specific manner, and thus can be tightly fixed to the patient's cervical vertebrae without a foreign body sensation.

[0034] To this end, the cervical fixation plate (100) is composed of a fixation plate body (110) that is 3D printed with titanium material based on the patient's spinal imaging data (e.g., MRI or CT imaging data) and is in close contact with the cervical vertebrae, and a screw detachment blocking plate (120) that is rotatably fastened to the fixation plate body (110).

[0035] The fixing plate body (110) of the above cervical fixing plate (100) is manufactured in a rectangular plate shape with a profile that fits the cervical vertebrae of the patient perfectly by 3D printing based on the patient's spinal imaging data, and as shown in FIG. 3a, a plurality of screw fastening holes (112) are formed at predetermined positions at the four corners, and an artificial disc observation window (114) is formed through the central region to allow observation of the artificial disc state during surgery.

[0036] In particular, the screw detachment blocking plate (120) of the cervical fixation plate (100) is manufactured as an oval plate structure in which a locking plate (122) is protruded on one side and a hexagonal wrench groove (124) is formed on the other side, and is rotatably fastened at an adjacent position to the screw fastening hole (112) on the upper surface of the fixation plate (110).

[0037] At this time, a space in which the screw detachment blocking plate (120) is inserted and fixed is formed at a position adjacent to the screw fastening hole (112) on the upper surface of the fixed plate body (110), and a fixing groove (116) is formed to guide the rotational trajectory of the screw detachment blocking plate (120) at a constant level. In addition, an insertion hole (116-1) is formed in the fixing groove (116) into which the rotational axis (123) of the screw detachment blocking plate (120) is inserted by force fitting.

[0038] In addition, as can be seen in FIG. 3b, a curved slide groove (118) is formed at a position on the side of the fitting hole (116-1) in the fixing groove (116) of the fixed plate body (110) to guide the rotational trajectory of the screw release blocking plate (120), and a first locking groove (117) and a second locking groove (119) are formed at both ends of the slide groove (118) to lock the screw release blocking plate (120) in order to prevent the screw release blocking plate (120) from rotating in the reverse direction after being rotated in one direction.

[0039] Meanwhile, a rotation shaft (123) that is rotatably forcibly fitted into the fitting hole (116-1) and a locking projection (126) that moves along the slide groove (118) and is locked and inserted into the first locking groove (117) or the second locking groove (119) are formed protruding at the bottom of the screw release blocking plate (120).

[0040] Here, the surgical process for fixing the cervical fixation plate of the present invention, which is composed of the above-described configuration, to the cervical vertebrae is as follows.

[0041] The attached Fig. 5 is a front view showing a state in which a cervical fixation plate according to the present invention is fastened to a cervical vertebra with a screw while in close contact with the cervical vertebra, and Fig. 6 is a front view showing a state in which a cervical fixation plate according to the present invention is fastened to a cervical vertebra with a screw and the screw detachment blocking plate is rotated to a screw locking position to lock the screw.

[0042] First, the fixing plate body (110) of the cervical fixing plate (100) is pressed against the cervical vertebra (200) into which the artificial disc (210) is inserted, and then, as shown in FIG. 5, a screw (130) is inserted and fixed into the cervical vertebra through the screw fixing hole (112).

[0043] At this time, when the fixing plate (110) is pressed against the cervical vertebra (200), the fixing plate (110) may slip on the surface of the cervical vertebra (200) which has a slippery surface and easily come out of its position, making it difficult to fix the cervical fixing plate (100) in its position during surgery.

[0044] To resolve this, as shown in Fig. 7, a non-slip groove (113) is formed on the lower surface of the fixed plate (110) to prevent slipping when in contact with the cervical vertebra (200).

[0045] Accordingly, when the fixed plate body (110) is pressed against the cervical vertebra (200), the anti-slip protrusions (113) are pressed against the surface of the cervical vertebra (200), so that the fixed plate body (110) can be firmly pressed against the desired position of the cervical vertebra (200) without slipping, and the process of inserting and fastening the screw (130) into the cervical vertebra through the screw fastening hole (112) can be easily performed.

[0046] At this time, the operator can check the position and condition of the artificial disc through the artificial disc observation window (114) formed in the fixed plate body (110), and accordingly, when the fixed plate body (110) is pressed against the cervical vertebra, the fixed plate body (100) can be prevented from coming into contact with the artificial disc, thereby preventing damage to the artificial disc, etc.

[0047] Next, after the screw (130) is fastened to the cervical vertebra (200) through the screw fastening hole (112), a rotating tool is inserted into the wrench groove (124) to rotate the screw detachment blocking plate (120) toward the screw (130).

[0048] At this time, since the screw detachment blocking plate (120) has its own elasticity, when a rotary tool is inserted into the wrench groove (124) to rotate the screw detachment blocking plate (120) toward the screw (130), the locking projection (126) of the screw detachment blocking plate (120) can be moved from the first locking groove (117) along the slide groove (118) and locked and inserted into the second locking groove (119), thereby preventing the screw detachment blocking plate (120) from being rotated in the reverse direction toward the first locking groove (117).

[0049] At the same time, when the screw detachment blocking plate (120) is rotated toward the screw (130), as shown in FIG. 6, the locking plate (122) formed on one side of the screw detachment blocking plate (120) is placed on the head (132) of the screw (130), thereby preventing the screw (130) from loosening and detaching.

[0050] More specifically, the locking plate (122) formed on one side of the screw detachment blocking plate (120) is placed in a locking position above the head (132) of the screw (130) as shown in FIG. 6, thereby preventing the screw (130) from being loosened and pushed outward from the cervical vertebrae (200) and the fixing plate body (110) of the cervical fixing plate (100) due to repetitive movement of the cervical vertebrae according to the behavior of the patient discharged from the hospital after surgery, and ultimately, the fixing state of the cervical fixing plate (100) is firmly maintained even after a certain period of time, so that the patient's cervical surgery progress can be maintained excellently.

[0051] Meanwhile, after the surgery to fix the cervical fixation plate (100), bone fusion occurs in which the bone is attached only to the screw (130) inserted into the cervical vertebra, and the bone is not attached to the inner surface of the fixation plate body (110) of the cervical fixation plate (100), so the close bonding force between the cervical fixation plate (100) and the cervical vertebra (200) may be weakened.

[0052] To resolve this, as shown in FIG. 8, a porous structural layer (115) is formed on the lower surface of the fixed plate (110) to prevent slippage when in contact with the cervical vertebra (200) and to induce bone fusion with the cervical vertebra (200).

[0053] Accordingly, after the surgery to fix the cervical fixation plate (100), bone fusion easily occurs in which the bone is attached to the porous structural layer (115) formed on the inner surface of the fixation plate body (110) of the cervical fixation plate (100), thereby easily inducing bone fusion between the cervical fixation plate (100) and the cervical vertebra (200), thereby improving the fixation bonding strength of the cervical fixation plate (100).

[0054] In this way, by manufacturing the cervical fixation plate (100) according to the present invention by 3D printing based on the patient's spinal imaging data (MRI or CT imaging data), a patient-specific cervical fixation plate that fits the patient's cervical surgery site can be provided, and further, the cervical fixation plate can be tightly and tightly fixed to the patient's cervical surgery site, thereby eliminating foreign body sensation caused by the cervical fixation plate even after surgery, thereby improving the patient's satisfaction with the cervical surgery.

[0055] Meanwhile, the cervical fixation plate (100) according to the present invention is manufactured using titanium material through 3D printing based on the patient's spinal imaging data (e.g., MRI or CT imaging data), and after the 3D printing is completed, a polishing step is performed to remove the titanium powder.

[0056] The above polishing step is a step for improving the surface roughness of the fixed plate body (110) using a polishing device. The media for performing this polishing step, a pin, is most preferably a cylindrical pin having a diameter of 0.3 to 1.2 mm and a length of 0.5 to 1.2 mm, but is not limited thereto. Therefore, before performing the polishing step, the manufacturer inserts the pin into the polishing device, places the fixed plate body (110) on the polishing stand, and then performs the polishing process using the pin.

[0057] At this time, when performing the polishing process, it is most preferable to use a polishing liquid provided to the fixed plate body (110) as a mixture of 1000 ml of water and 25 ml of existing polishing liquid, i.e., a mixture of water and polishing liquid in a ratio of 1:0.025.

[0058] That is, in the case of the fixed plate body (110) to be polished in the present invention, since it is directly inserted and fixed into the patient's body tissue after polishing, the polishing process can prevent rust from remaining, remove the oxide film, and at the same time, obtain the effect of removing foreign substances and cleaning.

[0059] Therefore, by using a mixture of water and polishing liquid as a polishing liquid in the polishing step, the above-described effect can be obtained and a fixed plate body (110) with improved perfection and safety can be obtained.

[0060] In addition, the above-described pin is rotated to polish the surface of the fixed plate body (110). At this time, variables that affect the surface roughness include the rotation speed (rpm) of the pin and the polishing time (min). The rotation speed and polishing time of the pin may vary depending on the shape and design of the fixed plate body (110). The rotation speed is adjusted within the range of 600 to 1200 rpm, and the polishing time is set to within 30 minutes to polish the surface of the fixed plate body (110).

[0061] For example, when performing a polishing process in the polishing step of the fixed plate body (110), the polishing time is set to 30 minutes for the maximum polishing time, and the rotation speed of the pin is also set to the maximum value of 1200 rpm to improve the surface roughness.

[0062] In addition, after the cervical fixation plate (100) is manufactured by 3D printing, the support, which is the residue after 3D printing, is removed.

[0063] That is, when producing a product using the above 3D printing, the original product cannot be produced as is, but support is connected and 3D printing output is performed. After printing, that part needs to be removed, the support is cut, and the part where the support was connected is smoothed through polishing.

[0064] In addition, after the cervical fixation plate (100) is manufactured by 3D printing, an anodizing process is performed.

[0065] That is, titanium, the material of the cervical fixation plate, has the characteristic of having an anodic oxide film that changes color in response to a specific voltage, so that by flowing a specific voltage (electrolyte), the titanium medical device can be used to change the color of the product, thereby providing a sense of aesthetic sophistication and distinguishing the size of the product.

Claims

1. A fixed plate body (110) manufactured by 3D printing based on the patient's spinal imaging data, with a structure in which multiple screw fastening holes (112) are formed at predetermined locations on all four corners and an artificial disc observation window (114) is formed through the central area, so as to be tightly fixed to the cervical vertebrae (200); and It is provided with an oval plate structure in which a locking plate (122) is protruded on one side and a wrench groove (124) is formed on the other side, and is configured to include a screw detachment blocking plate (120) that is rotatably fastened at an adjacent position to a screw fastening hole (112) on the upper surface of the fixed plate body (110); After the screw (130) is fastened to the cervical vertebra (200) through the screw fastening hole (112), a rotary tool is inserted into the wrench groove (124) to rotate the screw detachment blocking plate (120) toward the screw (130), so that the locking plate (122) is placed on the head (132) of the screw (130) to prevent the screw (130) from detaching; A space in which the screw detachment blocking plate (120) is inserted and fixed in an adjacent position of the screw fastening hole (112) on the upper surface of the fixed plate body (110) is formed, and a fixing groove (116) is formed to guide the rotational trajectory of the screw detachment blocking plate (120) at a constant level; A patient-specific cervical spine fixation plate using 3D printing technology, characterized in that a slide groove (118) having a first locking groove (117) and a second locking groove (119) at each end is formed in the fixing groove (116) of the fixed plate body (110), and a locking projection (126) is formed in the lower part of the screw detachment blocking plate (120) to move along the slide groove (118) and be locked and inserted into the first locking groove (117) or the second locking groove (119).

2. In claim 1, A patient-specific cervical fixation plate using 3D printing technology, characterized in that a non-slip groove (113) is formed on the lower surface of the above-mentioned fixation plate (110) to prevent slipping when in contact with the cervical vertebra (200).

3. In claim 1, A patient-specific cervical fixation plate using 3D printing technology, characterized in that a porous structural layer (115) is formed on the lower surface of the above-mentioned fixation plate (110) to prevent slippage when in contact with the cervical vertebra (200) and to induce bone fusion with the cervical vertebra (200).

Citation Information

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