CN110368149B

CN110368149B - Intervertebral disc prosthesis

Info

Publication number: CN110368149B
Application number: CN201910718883.2A
Authority: CN
Inventors: 王彩梅
Original assignee: Beijing AK Medical Co Ltd
Current assignee: Beijing AK Medical Co Ltd
Priority date: 2019-08-05
Filing date: 2019-08-05
Publication date: 2024-03-15
Anticipated expiration: 2039-08-05
Also published as: CN110368149A

Abstract

The present invention provides an intervertebral disc prosthesis comprising: the support is made of memory alloy and comprises a first structure, a second structure and a third structure which are sequentially connected, wherein two ends of the third structure are respectively connected with the first structure and the second structure, the first structure and the second structure are arranged at intervals, and an opening is formed between the first structure and the second structure; the support has a constraint state and a natural state, and the opening size of the opening of the support in the constraint state is smaller than that of the opening of the support in the natural state; and the elastic part is arranged between the first structure and the second structure, one side of the elastic part is connected with the first structure, and the other side of the elastic part is connected with the second structure. The technical scheme provided by the invention can solve the problem that the intervertebral disc prosthesis in the prior art is difficult to implant, can deform in a stress environment, and can meet the basic movement function of a human body.

Description

Intervertebral disc prosthesis

Technical Field

The invention relates to the technical field of medical appliances, in particular to an intervertebral disc prosthesis.

Background

After the cervical or lumbar disc of the human body is diseased, one of which is fusion surgery, the loss of mobility of the surgical segment after surgery may theoretically increase degeneration of the adjacent segment, so doctors begin to think and perform the operation of replacing the artificial disc, so that the mobility between the vertebral segments is maintained, and the surgical device is mainly used for the cervical vertebra at present. Lumbar artificial intervertebral discs are currently being developed relatively rarely.

The nucleus pulposus in the central part of human intervertebral disc is elastic gelatinous matter, and the fibrous ring in the peripheral part is arranged concentrically with the multi-layer fibrous cartilage ring and connected to the upper and lower vertebral bodies, so that it has the functions of stabilizing the vertebral column, absorbing shock, transmitting load and distributing stress, and has decisive function on the movement of the vertebral column. The nucleus pulposus is affected by factors and easily comes out to the rear and outer sides, protrudes into the vertebral canal or intervertebral foramen, presses spinal cord or medullary nerve and forms the herniated disc.

Spinal fusion is one of the current methods used to alleviate herniated disc, with the affected disc being resected first, followed by implantation of an artificial implant. The material used for the implant should have good biocompatibility and be effective to bridge the space left after disc removal.

Artificial disc replacement (total disc replacement TDR) is a new method for treating degenerative disc disease in recent years, and is beginning clinical application in the 80 s of the 20 th century. It not only resects the pathological change intervertebral disc, but also simultaneously restores the stability and activity function of the segment, and can theoretically avoid the adjacent segment degeneration acceleration caused by the spinal fusion operation. The artificial intervertebral disc replacement is mainly used for treating intervertebral disc degeneration diseases such as intervertebral disc-derived lumbago and the like.

In recent years, development and application of artificial intervertebral discs have been carried out at home and abroad, and the purpose of the artificial intervertebral discs is to achieve the effects of human body intervertebral disc excision decompression, fixation and fusion, prevent degeneration of adjacent segments and simultaneously maintain the physiological activity range of the spinal column.

The prior intervertebral disc prosthesis is formed by combining a plurality of parts, is limited by the structure of the intervertebral disc prosthesis and the structure of a vertebral body in an operation area, and has the problem that the prior intervertebral disc prosthesis is difficult to implant into the structure of the vertebral body of a human body.

Disclosure of Invention

The invention provides an intervertebral disc prosthesis, which aims to solve the problem that the intervertebral disc prosthesis in the prior art is difficult to implant into a human body.

In order to solve the above problems, the present invention provides an intervertebral disc prosthesis comprising: the support is made of memory alloy and comprises a first structure, a second structure and a third structure which are sequentially connected, wherein two ends of the third structure are respectively connected with the first structure and the second structure, the first structure and the second structure are arranged at intervals, and an opening is formed between the first structure and the second structure; the support has a constraint state and a natural state, and the opening size of the opening of the support in the constraint state is smaller than that of the opening of the support in the natural state; and the elastic part is arranged between the first structure and the second structure, one side of the elastic part is connected with the first structure, and the other side of the elastic part is connected with the second structure.

Further, the first structure comprises a first supporting part and a first bone trabecular layer arranged on the first supporting part, and the first supporting part is connected with the third structure; the second structure comprises a second supporting part and a second bone trabecular layer arranged on the second supporting part, the second supporting part is connected with the third structure, and the elastic part is arranged between the first supporting part and the second supporting part.

Further, the first bone trabecular layer and the second bone trabecular layer are both porous structures.

Further, the first supporting part comprises a first plate body and a first limiting piece arranged on one side of the first plate body, the first bone trabecula layer is arranged on the other side of the first plate body, the first plate body is connected with the third structure, and the first limiting piece is in limiting fit with one side of the elastic part; the second supporting part comprises a second plate body and a second limiting part arranged on one side of the second plate body, the second trabecular bone layer is arranged on the other side of the second plate body, the second plate body is connected with a third structure, and the second limiting part is in limiting fit with the other side of the elastic part.

Further, the first limiting piece is provided with a first limiting groove, the second limiting piece is provided with a second limiting groove, the first limiting piece and the second limiting piece are arranged at intervals, and the elastic part is arranged between the first limiting groove and the second limiting groove.

Further, the first supporting part further comprises a first fixing piece, the first fixing piece is arranged at one end of the first plate body far away from the third structure, the first fixing piece protrudes out of the first bone trabecular layer, and the first fixing piece is used for being connected with the human vertebral body structure; the second supporting part further comprises a second fixing piece, the second fixing piece is arranged at one end, far away from the third structure, of the second plate body, the second fixing piece protrudes out of the second bone trabecula layer, and the second fixing piece is used for being connected with the vertebral body structure of a person.

Further, the support is an integrally formed structure manufactured through 3D printing, and the support is made of nickel-titanium alloy.

Further, the elastic portion is made of a polymer material.

Further, the elastic part is made of polyurethane, polyvinyl alcohol gel or polylactic acid material through injection molding.

Further, the elastic part is of an ellipsoidal structure, the third structure is of a plate-shaped structure, and the length direction of the elastic part is along the length direction of the third structure.

Further, the intervertebral disc prosthesis further comprises: and the silica gel sleeve is filled in the cavity among the first structure, the second structure, the third structure and the elastic part.

By applying the technical scheme of the invention, the support and the elastic part are arranged in the intervertebral disc prosthesis, the support comprises a first structure, a second structure and a third structure which are sequentially connected, the elastic part is arranged between the first structure and the second structure, and an opening is arranged between the first structure and the second structure. Because the support is made of memory alloy, the support has a constraint state and a natural state, namely, the support can be converted into the constraint state by applying constraint or temperature change through a tool, so that the size of the opening can be reduced, the height of the support can be reduced, and when the constraint is removed or the temperature is restored to the original temperature, the support is converted into the natural state, and the opening is restored to the normal size.

Therefore, before the intervertebral disc prosthesis is implanted into the vertebral body structure of the human body, the bracket is firstly converted into a constraint state, so that the overall size of the intervertebral disc prosthesis can be reduced, the intervertebral disc prosthesis is conveniently implanted into the pathological change position of the vertebral body structure in a limited space, and the bracket is restored to a natural state after implantation, so that the intervertebral disc prosthesis is fused with the vertebral body structure of the human body and is normally used. During implantation, a prosthesis with a proper opening angle is selected, the front end of the bracket is compressed by an implantation tool to form deformation, the prosthesis is naturally opened after implantation, and meanwhile, the prosthesis can be restored to the preset angle of the prosthesis required by the pathological change part of the human body due to the function of restoring the original state of the memory alloy.

And the elastic part between the first structure and the second structure can deform under the stress environment so as to meet the basic movement function of a human body. The elastic part is made of polymer materials, has good ductility, breaking strength, wear resistance and biocompatibility, and can be combined with the bracket well, so that the overall performance of long-term implantation of the prosthesis is ensured. And the arrangement of the bracket can prevent the intervertebral space from being re-narrowed caused by the high loss, ensure the long-term reliable use of the intervertebral disc prosthesis and avoid the degeneration of the adjacent intervertebral disc.

Furthermore, the intervertebral disc prosthesis is of an integral structure, has high connection strength and good stability, avoids the problem that the intervertebral disc prosthesis adopting a plurality of parts needs to be assembled and combined and the problem that each part is easy to separate, and is convenient for a doctor to operate.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention. In the drawings:

FIG. 1 shows a schematic structural view of an intervertebral disc prosthesis provided by an embodiment of the present invention;

FIG. 2 shows a front view of the intervertebral disc prosthesis of FIG. 1;

FIG. 3 shows a cross-sectional view of FIG. 2 in the A-A position;

FIG. 4 shows a cross-sectional view of FIG. 2 in the B-B position;

FIG. 5 shows a schematic illustration of an intervertebral disc prosthesis according to an embodiment of the present invention with a silicone sleeve removed;

FIG. 6 shows a schematic structural view of the bracket of FIG. 1;

fig. 7 shows a front view of the bracket of fig. 6;

FIG. 8 shows a cross-sectional view of FIG. 7 in the C-C position;

fig. 9 shows a cross-sectional view of fig. 7 in the D-D position.

Wherein the above figures include the following reference numerals:

10. a first structure; 11. a first support portion; 111. a first plate body; 112. a first limiting member; 113. a first fixing member; 12. a first bone trabecular layer; 20. a second structure; 21. a second supporting part; 211. a second plate body; 212. a second limiting piece; 213. a second fixing member; 22. a second trabecular bone layer; 30. a third structure; 40. an elastic part; 50. and a silica gel sleeve.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. The following description of at least one exemplary embodiment is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

As shown in fig. 1 to 9, an embodiment of the present invention provides an intervertebral disc prosthesis comprising: the support is made of memory alloy and comprises a first structure 10, a second structure 20 and a third structure 30 which are sequentially connected, wherein two ends of the third structure 30 are respectively connected with the first structure 10 and the second structure 20, the first structure 10 and the second structure 20 are arranged at intervals, and an opening is formed between the first structure 10 and the second structure 20; the support has a constraint state and a natural state, and the opening size of the opening of the support in the constraint state is smaller than that of the opening of the support in the natural state; and an elastic portion 40 disposed between the first structure 10 and the second structure 20, one side of the elastic portion 40 being connected to the first structure 10, and the other side of the elastic portion 40 being connected to the second structure 20.

By applying the technical scheme of the invention, the support and the elastic part 40 are arranged in the intervertebral disc prosthesis, the support comprises a first structure 10, a second structure 20 and a third structure 30 which are sequentially connected, the elastic part 40 is arranged between the first structure 10 and the second structure 20, and an opening is arranged between the first structure 10 and the second structure 20. Because the support is made of memory alloy, the support has a constraint state and a natural state, namely, the support can be converted into the constraint state by applying constraint or change of the ambient temperature through a tool, so that the size of the opening can be reduced, the height of the support can be reduced, and when the constraint is removed or the temperature is restored to the original temperature, the support is converted into the natural state, and the opening is restored to the normal size.

Therefore, before the intervertebral disc prosthesis is implanted into the vertebral body structure of the human body, the bracket is firstly converted into a constraint state, so that the overall size of the intervertebral disc prosthesis can be reduced, the intervertebral disc prosthesis is conveniently implanted into the pathological change position of the vertebral body structure in a limited space, and the bracket is restored to a natural state after implantation, so that the intervertebral disc prosthesis is fused with the vertebral body structure of the human body and is normally used. In addition, the elastic portion 40 between the first structure 10 and the second structure 20 can be deformed under the stress environment, and the support can also be elastically deformed, so that the support and the elastic portion 40 are mutually matched to satisfy the basic movement function of the human body. During implantation, a prosthesis with a proper opening angle is selected, the front end of the bracket is compressed by an implantation tool to form deformation, the prosthesis is naturally opened after implantation, and meanwhile, the prosthesis can be restored to the preset angle of the prosthesis required by the pathological change part of the human body due to the function of restoring the original state of the memory alloy.

In the present embodiment, the first structure 10 includes a first supporting portion 11 and a first trabecular bone layer 12 disposed on the first supporting portion 11, the first supporting portion 11 being connected to the third structure 30; the second structure 20 includes a second support portion 21 and a second trabecular bone layer 22 disposed on the second support portion 21, the second support portion 21 being connected to the third structure 30, and the elastic portion 40 being disposed between the first support portion 11 and the second support portion 21. Connection to the upper and lower body vertebral structures of the intervertebral disc prosthesis is achieved by the first 12 and second 22 trabecular bone layers.

In this embodiment, both the first trabecular bone layer 12 and the second trabecular bone layer 22 are porous structures. Thus being convenient to combine with the centrum structure of the patient and realizing biological fusion. The first trabecular bone layer 12 and the second trabecular bone layer 22 may be formed using 3D printing or chemical vapor infiltration. The first bone trabecular layer 12 and the second bone trabecular layer 22 each have a plurality of pores therein, the pores having a size of 0.3mm to 1.5mm, and the first bone trabecular layer 12 and the second bone trabecular layer 22 each have a porosity of 50% or more.

Specifically, the first supporting portion 11 includes a first plate 111 and a first limiting member 112 disposed on one side of the first plate 111, the first trabecular bone layer 12 is disposed on the other side of the first plate 111, the first plate 111 is connected to the third structure 30, and the first limiting member 112 is in limiting fit with one side of the elastic portion 40; the second supporting portion 21 includes a second plate 211 and a second limiting member 212 disposed on one side of the second plate 211, the second trabecular bone layer 22 is disposed on the other side of the second plate 211, the second plate 211 is connected to the third structure 30, and the second limiting member 212 is in limiting fit with the other side of the elastic portion 40. The first trabecular bone layer 12 is supported by the first plate 111, and the first stopper 112 is connected to the elastic portion 40 to thereby limit the elastic portion 40. Accordingly, the second trabecular bone layer 22 may be supported by the second plate 211, and the elastic portion 40 may be connected to and restrained by the second restraining member 212.

Further, the first limiting member 112 has a first limiting groove, the second limiting member 212 has a second limiting groove, the first limiting member 112 and the second limiting member 212 are spaced apart, and the elastic portion 40 is disposed between the first limiting groove and the second limiting groove. The elastic part 40 can be reliably limited by the first limiting groove and the second limiting groove, and the elastic part 40 is prevented from falling off. The first limiting piece 112 and the second limiting piece 212 are arranged at intervals, so that the support is convenient to elastically deform. Specifically, the surface of the elastic portion 40 is an arc surface, the first limit groove and the second limit groove are arc grooves, and the shapes of the first limit groove and the second limit groove are matched with the surface of the elastic portion 40, so that the contact area can be increased, and the stability of connection is improved.

As shown in fig. 5, the first supporting part 11 further includes a first fixing member 113, the first fixing member 113 is disposed at an end of the first plate 111 away from the third structure 30, the first fixing member 113 protrudes from the first trabecular bone layer 12, and the first fixing member 113 is used for connecting with a vertebral body structure of a person; the second supporting portion 21 further includes a second fixing member 213, the second fixing member 213 is disposed at an end of the second plate 211 away from the third structure 30, the second fixing member 213 protrudes from the second trabecular bone layer 22, and the second fixing member 213 is configured to be connected with a vertebral body structure of a person. The first fixing member 113 and the second fixing member 213 can be reliably connected with the human vertebral body structure, and play a limiting role.

In this embodiment, the bracket is an integrally formed structure made by 3D printing, and the bracket is made of nickel-titanium alloy. The nickel-titanium alloy material has good memory performance, so that the bracket is convenient to deform, and implantation is convenient. The support is arranged into an integrated structure, so that on one hand, the overall structural strength of the support and the long-term stability of the intervertebral disc prosthesis can be improved, on the other hand, the number of parts of the intervertebral disc prosthesis can be reduced, assembly steps can be reduced, the intervertebral disc prosthesis can be integrally implanted, the operation is convenient, the use of doctors is convenient, and the operation quality and efficiency are improved.

In the present embodiment, the elastic portion 40 is made of a polymer material. The elastic portion 40 is made of a polymer material, and has good ductility, breaking strength, wear resistance and biocompatibility, so that the elastic portion can be well combined with the stent, and the overall performance of long-term implantation of the prosthesis is ensured.

Specifically, the elastic portion 40 may be made of polyurethane, polyvinyl alcohol gel or polylactic acid material by injection molding. The material has good stability, and the deformability and strength meet the long-term use requirement. Further, the elastic portion 40 may be made of polyurethane TPU. The materials have good ductility, fracture strength, wear resistance and biocompatibility, so that the materials can be well combined with a bracket, and the overall performance of long-term implantation of the prosthesis is ensured.

As shown in fig. 3 to 5, the elastic portion 40 has an ellipsoidal structure, the third structure 30 has a plate-like structure, and the length direction of the elastic portion 40 is along the length direction of the third structure 30. Through the arrangement, the intervertebral disc prosthesis is convenient to elastically deform so as to meet the movement requirement of a human body. Moreover, the elastic portion 40 has an ellipsoidal structure, so that the distribution of the applied force is relatively uniform. After the intervertebral disc prosthesis is implanted, the opening between the first structure 10 and the second structure 20 faces forward, and the requirement that the forward bending amplitude of the lumbar vertebra of a human body is relatively large is met because the side with the opening is relatively large in deformation capacity.

In this embodiment, the intervertebral disc prosthesis further comprises: the silicone cover 50 fills the cavity between the first structure 10, the second structure 20, the third structure 30, and the elastic part 40. Thus, the protection and space occupation can be realized. The silicone cover 50 may be filled in left and right sides of the first and second stoppers 112 and 212 in fig. 8, and wrap the elastic portion 40.

The technical scheme has the following characteristics and advantages: the intervertebral disc prosthesis is of an integral structure, has no risk of separating all parts, is convenient to implant and is simple to operate; the scheme can provide stretching region movement in the front-back direction without pursuing the axial rotation capacity of the cervical intervertebral disc, thereby being suitable for the movement characteristics of thoracolumbar, and being beneficial to ensuring good stability of the prosthesis; the bracket part is made of memory alloy, in particular TINI memory alloy, which HAs excellent biocompatibility, elasticity and large deformability, the surface can increase the bioactivity by increasing HA coating, and the corrosion resistance can be reduced by surface modification technology; the bracket is integrally manufactured in a 3D printing TINI memory alloy mode; the support is provided with a thin back wall, can provide buckling deformation and can deform in a stress environment of stress activity, so that the buckling and stretching movement of lumbar vertebrae is realized; when the implant is implanted, the prosthesis with a proper opening angle is selected, the front end is compressed by an implantation tool to form deformation, the implanted prosthesis is naturally opened, and meanwhile, the prosthesis can be restored to the preset angle of the prosthesis required by the pathological change part of the human body due to the function of restoring the original state of the memory alloy; the elastic part is made of polymer materials (such as polyurethane, polyvinyl alcohol gel and polylactic acid) with similar hardness and elasticity to natural physiological cartilage of a human body, particularly polyurethane TPU materials, and the polymer can deform under the stress environment of stress activity, so that the bending and stretching movement of lumbar vertebrae is realized; the silica gel sleeve fills the front chamber and the rear chamber of the metal bracket and wraps the elastic part, thereby playing a role in protection and space occupation.

The invention solves the problem that the traditional intervertebral disc is difficult to implant by utilizing the restorable capacity of the deformation of the memory alloy, and the central polymer elastic part solves the problem how the system deforms to achieve the basic movement function under the stress environment. The technical scheme is convenient for operation, and can solve the problems that the traditional intervertebral disc prosthesis is difficult to achieve biological fixation, multiple parts of the prosthesis are easy to generate structural failure, the friction surface is wear-resistant, the movement amplitude is not well controlled, the intervertebral disc prosthesis in the prior art is easy to dislocate, and the parts in the intervertebral disc prosthesis combined by the multiple parts are easy to separate.

The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An intervertebral disc prosthesis comprising:

the support is made of a memory alloy and comprises a first structure (10), a second structure (20) and a third structure (30), wherein two ends of the third structure (30) are respectively connected with the first structure (10) and the second structure (20) to form a -shaped structure, the first structure (10) and the second structure (20) are arranged at intervals, and an opening is formed between the first structure (10) and the second structure (20);

the support is in a constraint state and a natural state, and the opening size of the opening of the support in the constraint state is smaller than that of the opening of the support in the natural state;

an elastic part (40) arranged between the first structure (10) and the second structure (20), wherein one side of the elastic part (40) is connected with the first structure (10), and the other side of the elastic part (40) is connected with the second structure (20);

the bracket is an integrated structure manufactured through 3D printing;

the elastic part (40) is of an ellipsoidal structure, the third structure (30) is of a plate-shaped structure, and the length direction of the elastic part (40) is arranged along the length direction of the third structure (30).

2. The intervertebral disc prosthesis of claim 1, wherein the implant is a disc prosthesis,

the first structure (10) comprises a first supporting part (11) and a first trabecular bone layer (12) arranged on the first supporting part (11), and the first supporting part (11) is connected with the third structure (30);

the second structure (20) comprises a second supporting part (21) and a second trabecular bone layer (22) arranged on the second supporting part (21), the second supporting part (21) is connected with the third structure (30), and the elastic part (40) is arranged between the first supporting part (11) and the second supporting part (21).

3. Intervertebral disc prosthesis according to claim 2, wherein the first bone trabecular layer (12) and the second bone trabecular layer (22) are each of a porous structure.

4. The intervertebral disc prosthesis of claim 2, wherein the implant is a disc prosthesis,

the first supporting part (11) comprises a first plate body (111) and a first limiting piece (112) arranged on one side of the first plate body (111), the first trabecular bone layer (12) is arranged on the other side of the first plate body (111), the first plate body (111) is connected with the third structure (30), and the first limiting piece (112) is in limiting fit with one side of the elastic part (40);

the second supporting part (21) comprises a second plate body (211) and a second limiting part (212) arranged on one side of the second plate body (211), the second trabecular bone layer (22) is arranged on the other side of the second plate body (211), the second plate body (211) is connected with the third structure (30), and the second limiting part (212) is in limiting fit with the other side of the elastic part (40).

5. The intervertebral disc prosthesis according to claim 4, wherein the first stop (112) has a first stop slot and the second stop (212) has a second stop slot, the first stop (112) being spaced apart from the second stop (212), the resilient portion (40) being arranged between the first stop slot and the second stop slot.

6. The intervertebral disc prosthesis of claim 4, wherein the implant is a disc prosthesis,

the first supporting part (11) further comprises a first fixing piece (113), the first fixing piece (113) is arranged at one end of the first plate body (111) far away from the third structure (30), the first fixing piece (113) protrudes out of the first trabecular bone layer (12), and the first fixing piece (113) is used for being connected with a human vertebral body structure;

the second supporting part (21) further comprises a second fixing piece (213), the second fixing piece (213) is arranged at one end, far away from the third structure (30), of the second plate body (211), the second fixing piece (213) protrudes out of the second trabecular bone layer (22), and the second fixing piece (213) is used for being connected with a vertebral body structure of a person.

7. The intervertebral disc prosthesis of claim 1, wherein the scaffold is made of a nickel titanium alloy.

8. Intervertebral disc prosthesis according to any of claims 1 to 7, wherein the resilient part (40) is made of a polymeric material.

9. Intervertebral disc prosthesis according to claim 8, wherein the elastic portion (40) is made of polyurethane, polyvinyl alcohol gel or polylactic acid material by injection moulding.

10. The intervertebral disc prosthesis of any one of claims 1 to 7, further comprising:

and a silicone sleeve (50) filled in the cavity between the first structure (10), the second structure (20), the third structure (30) and the elastic part (40).