An artificial disc prosthesis capable of mimicking movement in all axes

The artificial disc prosthesis, featuring an upper, middle, and lower disc design that mimics intervertebral disc movements in all axes, addresses the limitations of existing prostheses by allowing flexion and maintaining movement, thus effectively treating cervical degenerative disc disease.

WO2025018962A1PCT designated stage Publication Date: 2025-01-23CELAL BAYAR UNIVERSITESI DIGER MERKEZLER MUDURLUGU
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Patent Information

Application Number
PCT/TR2024/050762
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-07-04
Publication Date
2025-01-23

AI Technical Summary

Technical Problem

Existing artificial disc prostheses for cervical degenerative disc disease do not allow for flexion movements and fail to maintain movement over time, often resulting in spontaneous bone fusion and loss of movement.

Method used

An artificial disc prosthesis comprising an upper disc, a middle disc with a convex form, and a lower disc, designed to mimic intervertebral disc movements in all axes, including flexion, by allowing sagittal, frontal, and transverse plane movements.

Benefits of technology

The artificial disc prosthesis enables patients to perform flexion and other movements in all axes, providing sustained mechanical support and reducing the risk of bone fusion, thereby alleviating symptoms of cervical degenerative disc disease.

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Abstract

The invention relates to an artificial disc prosthesis particularly suitable for use in the treatment of cervical degenerative disc disease, capable of mimicking all forward, backward, right and left movements in the sagittal or longitudinal, horizontal or axial or transverse planes, coronal or frontal planes and providing sufficient mechanical support for this.
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Description

[0001] DESCRIPTION

[0002] AN ARTIFICIAL DISC PROSTHESIS CAPABLE OF MIMICKING MOVEMENT IN ALL AXES

[0003] TECHNICAL FIELD

[0004] The invention relates to an artificial disc prosthesis particularly suitable for use in the treatment of cervical degenerative disc disease, capable of mimicking all forward, backward, right and left movements in the sagittal or longitudinal, horizontal or axial or transverse planes, coronal or frontal planes and providing sufficient mechanical support for this.

[0005] PRIOR ART

[0006] Cervical degenerative disc disease is the wear and deterioration of the discs between the vertebrae in the neck region due to the aging process. This can cause pain, stiffness and limitation of movement in the upper part of the spine (cervical spine). Cervical degenerative disc disease usually occurs as a result of the aging process. Discs are elastic structures located between the spine and act as a shock absorber between the vertebrae. Over time, the water content in these discs decreases, their elasticity decreases, and they wear out. This situation can cause the discs to lose height, jam or project. Cervical degenerative disc disease can cause symptoms such as neck pain, neck stiffness, shoulder pain, headache, arm pain, and numbness. Treatment methods such as physical therapy, use of neck brace or splint, injection therapy and surgical operations can be performed for cervical degenerative disc disease.

[0007] In case of advanced cervical degenerative disc disease, surgical operations can be performed for treatment. Some of these surgical operations are Anterior cervical discectomy and fusion (ASDF) operations. Anterior cervical discectomy and fusion (ASDF) operations are surgical procedures used in patients with symptoms resulting from cervical degenerative disc disease. This procedure involves the removal of the damaged disc in the spinal segment in the neck area and the fusion of the vertebrae. In these surgical operations, the diseased disc tissue is removed and following the elimination of spinal cord-nerve root compression, the cavity formed by the removal of the disc tissue is closed with bone graft and / or artificial cage systems, and the axial load is carried by providing mechanical support between the upper and lower vertebrae. Although this method is very satisfactory in terms of nerve tissue decompression, it results in loss of movement as the upper and lower vertebrae fuse with ossification in the relevant mobile segments. This leads to severe restriction in the movements of the neck and head. Furthermore, over time, the load passing through this region without being directly suspended causes load concentration in the upper and lower intervertebral discs, and the process of degradation in these discs accelerates, resulting in pathological degeneration and intervertebral disc disease at new distances. For the treatment of said diseases, artificial disc prostheses have been developed in recent years to mimic intervertebral disc movements. However, these artificial disc prostheses are far from mimicking movement in all axes. In particular, these artificial disc prostheses do not allow flexion movements.

[0008] In clinical studies, results have been obtained that the movements performed with artificial disc prostheses of the present art cannot be maintained for a long time and spontaneous bone fusion develops, thus losing the movement again. As a result, the ideal disc prosthesis has not yet been developed.

[0009] In the relevant technical field, the necessity of developing new artificial disc prostheses that is capable of mimicking intervertebral disc movements in all axes and has sufficient mechanical support properties for the treatment of cervical degenerative disc diseases has been determined.

[0010] SUMMARY OF THE INVENTION

[0011] Although cervical degenerative disc disease is generally known as a disease of old age, inactivity, harmful diet or habits have caused the incidence of these diseases to decrease to thirty-five. For the treatment of advanced cases of the disease and / or to prevent symptoms, surgical operations are performed to remove the diseased discs and replace them with artificial disc prostheses suitable for use. However, it has been determined that artificial disc prostheses of the present art do not have features that can mimic intervertebral disc movements in all axes.

[0012] In particular, these artificial disc prostheses do not allow flexion movements. In clinical studies, results have been obtained that the movements performed with artificial disc prostheses of the present art cannot be maintained for a long time and spontaneous bone fusion develops, thus losing the movement again.

[0013] In order to eliminate the existing technical problems in the relevant technical field and to provide additional technical solutions to the relevant technical field, the invention introduces an artificial disc prosthesis capable of mimicking intervertebral disc movements in all axes, particularly for the treatment of cervical degenerative disc diseases or for the alleviation of symptoms arising from these diseases.

[0014] An object of the invention is to introduce an artificial disc prosthesis that allows the patient to perform flexing movements.

[0015] An object of the invention is to introduce an artificial disc prosthesis that provides the necessary mechanical strength to perform movements in all axes.

[0016] BRIEF DESCRIPTION OF DRAWINGS

[0017] Fig. 1 shows a representative view of the artificial disc prosthesis of the invention.

[0018] Fig. 2 shows a frontal cross-sectional view of the artificial disc prosthesis of the invention with all its elements.

[0019] BRIEF DESCRIPTION OF REFERENCES

[0020] 10 Artificial Disc Prosthesis

[0021] 11 Upper Disc

[0022] 111 Upper Disc Recess

[0023] 112 Upper Disc Middle Connection Element

[0024] 113 Upper Disc Lateral Connection Element

[0025] 12 Middle Disc

[0026] 121 Middle Disc Lateral Connection Element

[0027] 13 Lower Disc

[0028] 131 Lower Disc Recess 132 Middle Connection Element Assembly Section

[0029] 133 Lateral Assembly Section

[0030] D Convex Form

[0031] DETAILED DESCRIPTION OF THE INVENTION

[0032] In this detailed explanation, the subject of the invention relates to an artificial disc prosthesis (10) suitable for use particularly in the treatment of cervical degenerative disc diseases or in the alleviation of the symptoms arising from these diseases, and is explained by way of example only for a better understanding of the subject, which shall not create any limiting effect.

[0033] The subject of this invention relates to a medical product that can provide treatment in surgical operations performed in cervical degenerative disc disease. In this respect, the invention is not related to a therapeutic method and the surgical operation itself. In surgical operations, providing treatment by placing the artificial disc prosthesis (10) of the invention in the cavity formed by the removal of the diseased disc is aimed. The innovative aspect of this invention is that the subject matter artificial disc prosthesis (10) can mimic intervertebral disc movements in all axes.

[0034] Fig. 1 shows the representative view of the artificial disc prosthesis (10) of the invention. Referring to Fig. 1 , artificial disc prosthesis (10) mainly consists of an upper disc (11), a middle disc (12) and a lower disc (13), respectively. These upper, middle and lower discs (11 , 12, 13) each have configurations that allow people to move on all axes. The object of this invention is to obtain an artificial disc prosthesis (10) that enables people to perform movements and flexions by mimicking intervertebral disc movements in the transverse plane, sagittal plane, and frontal plane.

[0035] As can be seen in Fig. 1 , the artificial disc prosthesis (10) of the invention has a circular geometric structure with diameters and dimensions suitable for use in the spinal cords. However, the scope of protection of the invention is not limited to the diameter and dimensions of the artificial disc prosthesis (10). Said artificial disc prosthesis (10) can be configured according to the surgical operation the patient will undergo and the dimensions of the prosthetic disc to be formed. The upper disc (11) contained in the artificial disc prosthesis (10) is located under the lumbar above it. The upper disc (11) allows the loads to be distributed in an even- balanced manner on the artificial disc prosthesis (10) by carrying and absorbing the loads imposed on the artificial disc prosthesis from the upper part. In this way, it prevents other elements in the artificial disc prosthesis (10) from being exposed to higher load distributions. The upper disc (11) enables sagittal or longitudinal (in the vertical direction) flexing and forward, backward, right and left, and approximately 1 mm lateral movement in the horizontal, axial or transverse plane, coronal or frontal plane of the artificial disc prosthesis (109) of the invention.

[0036] The upper disc (11) contains at least one upper disc recess (111). Said upper disc recess (111) allows the upper disc (11) to be mounted on the lumbars located above. In this invention, the dimensions and design of the upper disc recess (111) do not limit the scope of protection of the invention. In a preferred embodiment, the number of upper disc recesses (111 ) is more than one, and the amount can be determined to enable mounting of lumber-upper disc (11). In a preferred embodiment, the upper disc (11 )-upper disc recess (111) elements are monolithic elements.

[0037] The upper disc (11 ) contains configurations that facilitate its assembly with other elements within the artificial prosthetic disc (10) and makes it possible to introduce an artificial prosthetic disc (10) with the appearance shown in Fig. 1. To achieve this, the upper disc (11) contains an upper disc lateral connection element (113) that is formed along its circumference. As mentioned earlier, since the artificial disc prosthesis (10) has a circular form, the further upper disc (11 ) also has a similarly circular form, and said upper disc lateral connection element (113) also comprises upper disc lateral connection element (113) along the circumference of the upper disc (11). Referring to Fig. 2, the upper disc lateral connection element (113) has a projection within the upper disc (11) towards the middle disc (12) and the lower disc (13), i.e. downwards. The upper disc lateral connection element (113) moves towards the lateral assembly section (133) located on the lower disc (13) and engages with the section allocated to it depending on the shape in this region, allowing the artificial disc prosthesis (10) to be formed. The upper disc lateral connection element (113) is positioned in the lateral assembly section (133), including the middle disc lateral connection element (121). Accordingly, in the lateral assembly section (133), the middle disc lateral connection element (121) remains further inward than the upper disc lateral connection element (113), and the upper disc lateral connection element (113) forms the lateral circumference of the artificial disc prosthesis (10) in one direction.

[0038] The upper disc (11) contains an upper disc middle connection element (112) that allows the assembly of an artificial disc prosthesis (10). Said upper disc middle connection element (112) is located in the center of the upper disc (11) and the middle disc connection element (121) on the lower disc (13) has a length up to the assembly section. The upper disc middle connection element (112) is in a monolithic form with the upper disc (11 ) in a preferred embodiment, and the middle disc connection element (121 ) located on the lower disc (13) with a certain diameter has a T shape, as shown in Fig. 2, which allows assembly in accordance with the dimensions of the assembly section. The upper disc center connection element (112) extends from the center of the middle disc (12), which also has a cavity of its own diameter, towards the lower disc (13) and thus ensures assembly. In other words, in one aspect, the upper disc middle connection element (112) can enable the assembly of the middle disc (12) with the other elements. According to the aforementioned descriptions, the upper disc middle connection element (112) forms the spine of the artificial disc prosthesis (10), allowing the upper disc (11), middle disc (12) and lower disc (13) to be assembled from the center of the artificial disc prosthesis (10).

[0039] The lower disc (13) contains at least one lower disc recess (131). Said lower disc recess (131) allows the lower disc (13) to be mounted to the lumbars located below. In this invention, the dimensions and design of the lower disc recess (131) do not limit the scope of protection of the invention. In a preferred embodiment, the number of lower disc recesses (131) is more than one, the number of which can be determined to enable mounting of lumber-lower disc (13). In a preferred embodiment, the lower disc (13)-lower disc recess (131 ) elements are monolithic elements.

[0040] The lower disc (13) contains assembly regions to ensure the integrity of all elements in the artificial disc prosthesis (20) with the assembly. One of these is that it comprises a recess depending on the shape to allow the assembly of the middle disc lateral connection element (121) and the upper disc lateral connection element (113). In order to ensure assembly, the middle disc lateral connection element (121) and the upper disc lateral connection element (113) form a projection form, while the lateral assembly section (133) of the middle disc (12) form the suitable recess for these projections. Accordingly, the lateral assembly section (133), the middle disc lateral connection element (121) and the upper disc lateral connection element (113) have the dimensions to be assembled together.

[0041] The lower disc (13) contains a middle connection element assembly section (132) as another assembly section that ensures the integrity of all elements in the artificial disc prosthesis (10) by assembly. Referring to Fig. 2, the middle connection assembly section (132) is located in the center of the lower disc (13) and in the form of a recess that coincides with the position of the upper disc middle connection element (112). In this way, it is possible to ensure the integrity of the artificial disc prosthesis (10) from the center by engaging the middle connection assembly section (132)-upper disc middle connection element (112) and ensuring assembly.

[0042] The lower disc (13) is fixed to the lumbar, so that relative movements can occur between the lower lumbar and the upper lumbar according to all the movements made by the upper disc. Sagittal or longitudinal (in the vertical direction) flexion and forward, backward, right and left movement, and approximately 1 mm lateral movement in the horizontal, axial or transverse plane, coronal or frontal plane are ensured.

[0043] Unlike the disc prosthesis known in the art, the artificial disc prosthesis (10) of the invention comprises a middle disc (12) that allows movement and the lumbars to flex vertically in the sagittal plane, flex right-left in the frontal plane, flex forward-backward in the transverse direction relative to each other, and perfects the movements of other elements known in the art. In a preferred embodiment, the middle disc (12) is manufactured from a flexible material. In a preferred embodiment, the middle disc (12) essentially has the form of an arc. This arc form represents the reducing the shape of the artificial disc prosthesis (10) when the load is imposed and its return to its normal form when the load is removed. The most important arrangement for this is that the middle disc (12) has a convex form (D) that descends from a certain height from the central region, which is connected to the upper disc (11), to the middle disc lateral connection element (121), which is connected to the lower disc (13). The convex form (D) of the middle disc (12) is shown in Fig. 2. "Convex form" (D) refers to the condition in which an object or surface has a curved or elevated shape outward relative to its surroundings. This means that an object creates a curved surface outside its central line. The middle disc (12) contains a middle disc lateral connection element (121 ) that provides communication with other elements in order to ensure the integrity of the artificial disc prosthesis (10). The middle disc lateral connection element (121) has a projection form that coincides with the previously characterized lateral assembly section (133). The middle disc lateral connection element (121) is advanced towards the lateral assembly section (133) so that it can be positioned more internally than the upper disc lateral connection element (113).

[0044] According to the aforementioned descriptions, the artificial disc prosthesis (10) of the invention, owing to the upper, lower and middle discs (11 , 13, 12) it comprises, is in a form that allows flexion in the vertical direction in the sagittal plane, flexion to the rightleft in the frontal plane, and flexion of approximately 1 mm to the front-back in the transverse plane, in addition to the movements known in the art. In this way, it can be seen that the artificial disc prosthesis (10) performs movements by mimicking the movements of the intervertebral disc. The upper and lower discs (13, 11) can be attached to the lumbars by the recess while providing the movements known in the art. The middle disc (12), on the other hand, can provide movements in the sagittal, frontal and transverse planes, unlike the artificial disc prostheses (10) in the art. The biggest factor in providing these movements is the unique convex (D) design of the middle disc (12). The convex form (D) has made it possible to perform movements by providing flexibility compared to artificial disc prostheses (10) known in the art. Owing to its convex (D) form, the middle disc (12) can open from the center to the lateral regions during movements and provide the targeted elastic feature to the final artificial disc prosthesis (10).

[0045] Since the artificial disc prosthesis (10) of the invention is a biomedical product, it must be manufactured from advanced biocompatible materials. While the artificial disc prosthesis (10) provides the specified technical features with its unique design, it is also essential that the materials to be manufactured are biocompatible. Accordingly, it may be preferable to use more flexible materials suitable for the region to be treated as raw materials. In a preferred embodiment, the lower, upper and middle disc (13, 11 , 12) elements in the artificial disc prosthesis (10) are all manufactured from the same material. In another preferred embodiment, it can also be manufactured from different materials that are compatible with each other, which will not interfere with the technical solutions and advantages to be provided by the design of the artificial disc prosthesis (10). In the invention, at least one of a group of aluminum metal or its alloys, steel, titanium or its alloys, cobalt metal or its alloys, and polymer materials such as PEEK, PE, PP, which can be biocompatible as raw materials, can be used in the artificial disc prosthesis (10) and therefore in the production of the elements.

[0046] The artificial disc prosthesis (10) of the invention offers technical solutions and advantages for the technical field related to its elements and the original designs of the elements. How these designs are obtained is not limited by the scope of protection of the invention. Techniques such as machining, chipless machining, 3D printer manufacturing can be used as suitable forming methods.

[0047] The scope of protection of the invention is specified in the appended claims and cannot be limited to what is described for illustrative purposes in this detailed description. It is clear that a person skilled in the art can produce similar embodiments in the light of what is explained above, without deviating from the main theme of the invention.

Claims

CLAIMS1. An artificial disc prosthesis (10) suitable for use as a biomedical product in the treatment of cervical degenerative disc disease and similar spinal cord disorders, characterized in that it comprises the following elements capable of mimicking all forward, backward, right and left movements in the sagittal or longitudinal, horizontal or axial or transverse planes, coronal or frontal planes and providing sufficient mechanical support for this,- an upper disc (11) which allows the loads to be distributed in an even- balanced manner on the artificial disc prosthesis (10) by carrying and absorbing the loads imposed on the artificial disc prosthesis (10) from the upper part and which, with at least one upper disc recess (111) thereon, can be mounted to the neighboring lumbar above;- a lower disc (13) which comprises assembly regions to ensure the integrity of all the elements in the artificial disc prosthesis (10) by assembly, absorbs the loads from the upper and lower regions, and which, with at least one lower disc recess (131) thereon, can be mounted to the neighboring lumbar below;- a middle disc located between the lower and upper disc (13, 11), which provides flexibility by reducing the shape of the artificial disc prosthesis when the load is imposed, and allows it to return to its normal form when the load is removed, has an outwardly curved convex form (D) descending from a certain height from the center region, which is connected to the upper disc (11), to the middle disc lateral connection element (121), which is connected to the lower disc (13).

2. An artificial disc prosthesis (10) according to Claim 1 , characterized in that said upper disc (11) contains an upper lateral connection element (113) which is formed as a projection along its circumference for assembling the artificial disc prosthesis (10) from lateral regions.

3. An artificial disc prosthesis (10) according to one of the preceding claims, characterized in that the upper disc (11) contains an upper disc middle connection element (112) which is formed as a projection along its circumference for assembling the artificial disc prosthesis (10) from the central region.

4. An artificial disc prosthesis (10) according to one of the preceding claims, characterized in that said middle disc (12) contains a middle disc lateral connection element (121) which is formed as a projection along its circumference for assembling the artificial disc prosthesis (10) from lateral regions and the middle disc (12) with the upper and lower discs (11 , 13).

5. An artificial disc prosthesis (10) according to one of the preceding claims, characterized in that said lower disc (13) contains a lateral assembly section (133) which is formed as a recess along its circumference for assembling the artificial disc prosthesis (10) from lateral regions and the lower disc (13) with the upper and middle discs (11 , 12).

6. An artificial disc prosthesis (10) according to one of the preceding claims, characterized in that the lower disc (13) contains a middle connection element assembly section which is formed as a recess along its circumference for mounting the artificial disc prosthesis (10) from the central region.

Citation Information

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