AN ARTIFICIAL DISC PROSTHESIS THAT CAN MIMATES MOVEMENTS ON ALL AXES

Abstract

The invention relates to an artificial intervertebral disc prosthesis that can mimic all movements in the sagittal or longitudinal, horizontal or axial or transverse plane, in coronal or frontal planes, forwards, backwards, right and left, and provides sufficient mechanical support for this, in particular for use in the treatment of cervical degenerative disc disease.

Description

TECHNICAL AREA

[0001] The invention relates to an artificial intervertebral disc prosthesis that can mimic all movements in the sagittal or longitudinal, horizontal or axial or transverse plane, in coronal or frontal planes, forwards, backwards, right and left, and provides sufficient mechanical support for this purpose, in particular for use in the treatment of cervical degenerative disc disease. STATE OF THE ART

[0002] Cervical degenerative disc disease (CPD) is an age-related wear and tear of the intervertebral discs between the vertebrae in the neck. This can lead to pain, stiffness, and restricted movement in the upper part of the spine (cervical spine). CPD typically occurs as a result of the aging process. The intervertebral discs are elastic structures between the vertebrae and act as shock absorbers. Over time, the water content of these discs decreases, their elasticity diminishes, and they wear down. This can cause the discs to lose height, become compressed, or protrude. CPD can cause symptoms such as neck pain, neck stiffness, shoulder pain, headaches, arm pain, and numbness.Treatment methods for cervical degenerative disc disease can include physiotherapy, wearing a neck brace or splint, injection treatments and surgical procedures.

[0003] In advanced cases of cervical degenerative disc disease, surgical interventions may be performed. One such surgical procedure is anterior cervical discectomy and fusion (ACDF). ACDF procedures are used in patients with symptoms due to cervical degenerative disc disease. This procedure involves removing the damaged disc in the cervical spine and fusing the vertebrae.In these surgical procedures, the diseased intervertebral disc tissue is removed, and after relieving the pressure on the spinal cord and nerve roots, the gap created by the disc removal is closed with bone grafts and / or artificial bone substitutes. This creates a mechanical support between the upper and lower vertebrae that absorbs the axial load. While this procedure is very satisfactory in terms of decompression of the nerve tissue, the ossification (fusion) of the upper and lower vertebrae in the affected mobile segments leads to a loss of mobility. This results in a significant restriction of neck and head movement.Furthermore, the load passing through this area over time without direct cushioning leads to a concentration of stress on the upper and lower intervertebral discs, accelerating their degeneration and resulting in pathological degeneration and disc disease in new areas. To treat these conditions, artificial disc prostheses have been developed in recent years that mimic the movements of natural discs. However, these artificial disc prostheses are far from replicating movement in all axes. In particular, they do not allow for extension movements.

[0004] Clinical studies have shown that the range of motion achieved with artificial disc prostheses using current techniques could not be maintained long-term, and spontaneous bone fusion occurred, resulting in a loss of mobility. In conclusion, the ideal disc prosthesis has not yet been developed.

[0005] In the relevant technical field, it was determined that it is necessary to develop new artificial disc prostheses that can mimic the movements of the intervertebral discs in all axes and have sufficient mechanical support properties to treat degenerative disc diseases in the cervical spine. SUMMARY OF THE INVENTION

[0006] Although cervical degenerative disc disease is generally known as an age-related condition, lack of exercise, unhealthy diet, and lifestyle habits have led to a decrease in the incidence of this disease to as low as 35 years of age. Surgical procedures are performed to treat advanced stages of the disease and / or to prevent symptoms, in which the diseased discs are removed and replaced with suitable artificial disc prostheses. However, it has been found that current artificial disc prostheses are unable to mimic the movements of the intervertebral discs in all axes.

[0007] In particular, these artificial disc prostheses do not allow for stretching movements.

[0008] Clinical studies have shown that the movements achieved with artificial disc prostheses using previous techniques could not be maintained in the long term, and spontaneous bone fusion occurred, resulting in a loss of mobility.

[0009] In order to solve the existing technical problems in this area and to provide additional technical solutions for this area, the invention presents an artificial intervertebral disc prosthesis that can mimic the movements of the intervertebral discs in all axes, in particular for the treatment of degenerative disc diseases of the cervical spine or for the relief of the symptoms caused by these diseases.

[0010] One of the project's objectives is to develop an artificial intervertebral disc prosthesis that allows patients to perform stretching movements.

[0011] One of the project's objectives is to develop an artificial intervertebral disc prosthesis that provides the necessary mechanical strength for movements in all axes. BRIEF DESCRIPTION OF THE DRAWINGS Fig. Figure 1 shows a representative view of the artificial intervertebral disc prosthesis according to the invention. Fig. Figure 2 shows a front view of the artificial intervertebral disc prosthesis according to the invention with all its components. BRIEF DESCRIPTION OF THE REFERENCE NUMBERS 10 Artificial disc prosthesis 11 Upper intervertebral disc 111 Upper disc foramen 112 Middle connecting element of the upper intervertebral disc 113 Lateral connecting element of the upper intervertebral disc 12 Middle intervertebral disc 121 Lateral connecting element of the middle intervertebral disc 13 Lower intervertebral disc 131 Lower disc foramen 132 Mounting area of ​​the middle connecting element 133 Side mounting area D convex shape DETAILED DESCRIPTION OF THE INVENTION

[0012] In this detailed description, the subject matter of the invention relates to an artificial intervertebral disc prosthesis (10) which is particularly suitable for use in the treatment of cervical degenerative disc diseases or for alleviating the symptoms caused by these diseases, and is explained by means of examples which serve only for better understanding and have no limiting effect.

[0013] The subject matter of this invention relates to a medical product that can be used for treatment during surgical procedures for cervical degenerative disc disease. In this respect, the invention does not relate to a therapeutic method or the surgical procedure itself. During surgical procedures, treatment is achieved by inserting an artificial disc prosthesis (10) according to the invention into the cavity created by the removal of the diseased disc. The innovative aspect of this invention is that the artificial disc prosthesis (10) can mimic the movements of the intervertebral disc in all axes.

[0014] A representative view of the artificial disc prosthesis (10) according to the invention is shown in Fig. 1 shown. Referring to Fig. 1 The artificial disc prosthesis (10) essentially comprises an upper disc (11), a middle disc (12), and a lower disc (13). The upper, middle, and lower discs (11, 12, 13) each have configurations that allow individuals to move in all axes. The object of this invention is to develop an artificial disc prosthesis (10) that enables movements and extensions to be performed by mimicking the movements of the intervertebral discs in the transverse, sagittal, and frontal planes.

[0015] As in Fig. As shown in Figure 1, the artificial disc prosthesis (10) according to the invention has a circular geometric structure with a diameter and dimensions suitable for use in the spine. However, the scope of protection of the invention is not limited to the diameter and dimensions of the artificial disc prosthesis (10). The artificial disc prosthesis (10) can be configured according to the surgical procedure the patient will undergo and the dimensions of the prosthetic disc to be used.

[0016] The upper disc (11) of the artificial disc prosthesis (10) is located below the lumbar spine above it. The upper disc (11) enables an even distribution of the load on the artificial disc prosthesis (10) by bearing and absorbing the loads acting on it from above. In this way, the other elements of the artificial disc prosthesis (10) are prevented from being subjected to higher load distributions. The upper disc (11) allows the artificial disc prosthesis (109) according to the invention to bend in the sagittal or longitudinal (vertical) direction, and to move forward, backward, right, and left in the horizontal, axial, or transverse plane, and in the coronal or frontal plane, as well as laterally by approximately 1 mm.

[0017] The upper intervertebral disc (11) contains at least one upper disc recess (111). The upper disc recess (111) allows the upper intervertebral disc (11) to be mounted on the lumbar vertebrae located above it. In this invention, the scope of protection is not limited by the dimensions and design of the upper disc recess (111). In a preferred embodiment, the number of upper disc recesses (111) is greater than one, and their quantity can be determined such that the mounting of the upper intervertebral disc (11) is possible. In a preferred embodiment, the elements of the upper intervertebral disc (11) and the upper disc recess (111) are integral components.

[0018] The upper disc (11) contains configurations that facilitate assembly with other elements of the artificial prosthetic disc (10) and enables the fabrication of an artificial prosthetic disc (10) with the in Fig. 1. The appearance is shown in Figure 1. To ensure this, the upper disc (11) includes a shaped lateral connecting element (113) along its circumference. As mentioned previously, the artificial disc prosthesis (10) has a circular shape, so the upper disc (11) also has a similar circular shape, with the lateral connecting element (113) of the upper disc also including a lateral connecting element (113) of the upper disc along its circumference. Referring to Fig. 2 The lateral connecting element (113) of the upper intervertebral disc has a projection within the upper intervertebral disc (11) towards the middle intervertebral disc (12) and the lower intervertebral disc (13) – i.e., downwards. The lateral connecting element (113) of the upper intervertebral disc moves towards the lateral mounting area (133) of the lower intervertebral disc (13) and engages in this area according to its shape in the designated recess, thereby creating the artificial intervertebral disc prosthesis (10). The lateral connecting element (113) of the upper intervertebral disc is positioned on the lateral mounting area (133) such that it also encompasses the lateral connecting element (121) of the middle intervertebral disc.Accordingly, the lateral connecting element (121) of the middle intervertebral disc remains further inward in the lateral mounting area (133) than the lateral connecting element (113) of the upper intervertebral disc, and the lateral connecting element (113) of the upper intervertebral disc forms the lateral perimeter of the artificial disc prosthesis (10) in one direction.

[0019] The upper intervertebral disc (11) contains a central connecting element (112) that facilitates the assembly of the artificial disc prosthesis (10). The central connecting element (112) of the upper disc is located in the center of the upper intervertebral disc (11) and extends to the assembly area of ​​the connecting element (121) of the middle intervertebral disc located in the lower intervertebral disc (13). In a preferred embodiment, the central connecting element (112) of the upper intervertebral disc is formed integrally with the upper intervertebral disc (11) and has, as shown in Fig. Figure 2 shows a T-shape that allows assembly according to the dimensions of the mounting area of ​​the connecting element (121) of the middle intervertebral disc, which is located in the lower intervertebral disc (13) with a specific diameter. The middle connecting element (112) of the upper intervertebral disc also extends from the middle part of the middle intervertebral disc (12), which has a cavity corresponding to its diameter, to the lower intervertebral disc (13), thus ensuring assembly. That is, in a certain sense, the middle connecting element (112) of the upper intervertebral disc can enable the assembly of the middle intervertebral disc (12) to other elements.According to all the representations described here, the middle connecting element (112) of the upper disc forms the backbone of the artificial disc prosthesis (10) and enables the assembly of the upper disc (11), the middle disc (12) and the lower disc (13) of the artificial disc prosthesis (10) in the middle.

[0020] The lower intervertebral disc (13) contains at least one lower disc recess (131). The lower disc recess (131) enables the lower intervertebral disc (13) to be mounted to the lumbar vertebrae located below it. In this invention, the scope of protection is not limited by the dimensions and design of the lower disc recess (131). In a preferred embodiment, the number of lower disc recesses (131) is greater than one, and their quantity can be determined such that the mounting of the lower intervertebral disc (13) is possible. In a preferred embodiment, the elements of the lower intervertebral disc (13) and the lower disc recess (131) are integral components.

[0021] The lower intervertebral disc (13) includes the mounting areas in which all elements of the artificial disc prosthesis (20) are mounted to ensure its integrity. One of these includes a form-fitting recess to facilitate the mounting of the lateral connecting element (121) of the middle intervertebral disc and the lateral connecting element (113) of the upper intervertebral disc. To ensure proper mounting, the lateral connecting element of the middle intervertebral disc (121) and the lateral connecting element of the upper intervertebral disc (113) form a projection, while the lateral mounting area (133) in the middle intervertebral disc (12) forms a recess corresponding to these projections. Thus, the lateral mounting area (133), the lateral connecting element of the middle intervertebral disc (121), and the lateral connecting element of the upper intervertebral disc (113) have dimensions that allow for their joint assembly.

[0022] The lower intervertebral disc (13) includes a further assembly section, namely the assembly section (132) of the central connecting element, which enables the assembly of all elements of the artificial intervertebral disc prosthesis (10) and thus ensures its integrity. Referring to Fig. 2 The mounting area (132) of the central connecting element is arranged to correspond with the position of the central connecting element (112) of the upper intervertebral disc and is located in the form of a recess in the center of the lower intervertebral disc (13). In this way, the central integrity of the artificial disc prosthesis (10) is ensured by connecting and assembling the mounting area of ​​the central connecting element (132) and the connecting element (112) of the upper intervertebral disc.

[0023] The lower intervertebral disc (13) is fixed to the lumbar spine, so that relative movements can occur between the lower and upper lumbar spine corresponding to all movements of the upper intervertebral disc. It can move anteriorly, posteriorly, right and left in the sagittal or longitudinal (vertical) direction, in the horizontal, axial or transverse plane, in the coronal or frontal plane, and can be displaced laterally by approximately 1 mm.

[0024] The artificial disc prosthesis (10) according to the invention, in contrast to disc prostheses known in the art, comprises a central disc (12) that allows vertical flexibility of the lumbar vertebrae relative to each other in the sagittal plane, flexibility to the right and left in the frontal plane, flexibility anteriorly and posteriorly in the transverse plane, and movement, thus perfecting the movements of the other elements known in the art. In a preferred embodiment, the central disc (12) is made of a flexible material. In a preferred embodiment, the central disc (12) essentially has a spring shape. This spring-like shape illustrates how the artificial disc prosthesis (10) shrinks under load and returns to its normal shape after unloading.The most important embodiment that makes this possible is a convex shape (D) that slopes down from a certain height from the central region (12) of the middle intervertebral disc, which is connected to the upper disc (11), to the lateral connecting element (121) of the middle intervertebral disc, which is connected to the lower intervertebral disc (13). The convex shape (D) of the middle disc (12) is shown in . Fig. Figure 2 illustrates a “convex shape” (D) that describes the condition in which an object or surface is curved or raised outwards compared to its surroundings. This means that an object forms a curved surface outside its centerline.

[0025] The middle disc (12) contains a lateral connecting element (121) that connects to other elements to ensure the integrity of the artificial disc prosthesis (10). The lateral connecting element (121) of the middle disc has a protruding shape that corresponds to the previously characterized lateral mounting area (133). The lateral connecting element (121) of the middle disc is displaced toward the lateral mounting area (133) so that it can be positioned further inward relative to the lateral connecting element (113) of the superior disc.

[0026] According to all the descriptions mentioned herein, the artificial disc prosthesis (10) according to the invention, thanks to the upper, lower, and middle discs (11, 13, 12) it contains, is designed to allow, in addition to movements known in the art, vertical bending in the sagittal plane, bending to the right and left in the frontal plane, and bending of approximately 1 mm forward and backward in the transverse plane. This makes it clear that the artificial disc prosthesis (10) mimics and performs the movements of the intervertebral discs. The upper and lower discs (13, 11) enable movements known in the art and can be anchored in the lumbar vertebrae by means of their recesses. In contrast to artificial disc prostheses (10) used in the art, the middle disc (12) can allow movements in the sagittal, frontal, and transverse planes.The most important factor in achieving these movements is, again, the unique convex (D) design of the central disc (12). The convex shape (D), due to its flexibility compared to conventional artificial disc prostheses (10), enables the execution of movements. Thanks to its convex (D) shape, the central disc (12) can flex from the center to the lateral regions during movements, thus ensuring the desired elasticity of the final product, the artificial disc prosthesis (10).

[0027] The artificial disc prosthesis (10) according to the invention must be made of biocompatible materials, as it is a biomedical product. Due to its unique design, the artificial disc prosthesis (10) must meet the specified technical requirements, making it essential that the materials used are biocompatible. Accordingly, it may be advantageous to use more flexible materials as raw materials suitable for the area to be treated. In a preferred embodiment, the lower, upper, and middle discs (13, 11, 12) of the artificial disc prosthesis (10) are all made of the same material. In another preferred embodiment, the artificial disc prosthesis (10) can also be made of different, mutually compatible materials without compromising the technical solutions and advantages achieved through its design.In the invention, at least one of the following materials can be used: aluminum metal or alloys, steel, titanium or alloys, cobalt metal or alloys, PEEK, PE, PP and other polymeric materials which are biologically compatible as raw materials for the manufacture of artificial intervertebral disc prostheses (10) and natural elements.

[0028] The invented artificial intervertebral disc prosthesis (10) offers technical solutions and advantages for the technical field with regard to its components and their original designs. The manner in which the designs in question are achieved is not limited by the scope of protection of the invention. Suitable forming methods include techniques such as machining and non-machining manufacturing as well as manufacturing with 3D printers.

[0029] The scope of protection of the invention is specified in the appended claims and cannot be limited to what is described in this detailed description for exemplary purposes. This is because it is clear that a person skilled in the art can describe similar embodiments in light of the above without deviating from the main subject matter of the invention.

Claims

[1] Artificial disc prosthesis (10) as a biomedical product suitable in particular for use in the treatment of cervical degenerative disc disease and similar spinal disorders, being able to mimic all movements in the sagittal or longitudinal, horizontal or axial or transverse plane, in coronal or frontal planes, forward, backward, right and left, and providing sufficient mechanical support for this purpose, characterized by , that it includes: - an upper intervertebral disc (11) which enables the artificial disc prosthesis (10) to distribute loads evenly by transferring and absorbing loads exerted on the upper part of the artificial disc prosthesis (10), and which can be attached to the adjacent lumbar vertebrae by means of at least one upper disc recess (111) arranged therein; - a lower intervertebral disc (13) comprising mounting areas for attaching all elements contained in the artificial intervertebral disc prosthesis (10) to ensure its integrity, absorbing loads from the upper and lower areas, and which can be attached to the adjacent lumbar vertebrae by means of at least one lower intervertebral disc recess (131) arranged therein, - A middle disc, located between the lower and upper discs (13, 11), provides flexibility by reducing the shape of the artificial disc prosthesis under load and allowing it to return to its normal shape when unloaded, and has an outwardly curved convex shape (D) that slopes from a certain height from the middle area connected to the upper disc (11) to the lateral connecting element (121) of the middle disc, which is connected to the lower disc (13). [2] Artificial intervertebral disc prosthesis (10) according to claim 1, characterized by , that it includes an upper lateral connecting element (113) which is designed as a projection around the circumference of the upper intervertebral disc (11) to allow the assembly of the artificial intervertebral disc prosthesis (10) from the lateral areas. [3] Artificial intervertebral disc prosthesis (10) according to any of the preceding claims, characterized by , that it includes a central connecting element (112) of the upper intervertebral disc, which is designed as a projection around the circumference of the upper intervertebral disc (11) to allow the assembly of the artificial intervertebral disc prosthesis (10) from the central areas. [4] Artificial intervertebral disc prosthesis (10) according to any one of the preceding claims, characterized by, that it includes a lateral connecting element (121) of the middle intervertebral disc, which is designed as a projection around the circumference of the middle intervertebral disc (12) to allow the assembly of the artificial intervertebral disc prosthesis (10) from the middle areas and the middle intervertebral disc (12) with the upper and lower intervertebral discs (11, 13). [5] Artificial intervertebral disc prosthesis (10) according to any one of the preceding claims, characterized by , that it includes a lateral mounting area (133) which is designed as a recess around the circumference of the lower intervertebral disc (13) to allow the mounting of the artificial intervertebral disc prosthesis (10) from the middle areas and the lower intervertebral disc (13) to the upper and middle intervertebral disc (11, 12). [6] Artificial intervertebral disc prosthesis (10) according to any one of the preceding claims, characterized by, that it includes a mounting area of ​​the central connecting element, which is designed as a recess around the circumference of the lower intervertebral disc (13) to allow the mounting of the artificial intervertebral disc prosthesis (10) from the central areas.

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