WO2016201695A1

WO2016201695A1 - Interspinous stabilizer

Info

Publication number: WO2016201695A1
Application number: PCT/CN2015/081942
Authority: WO
Inventors: 李照文
Original assignee: 李照文
Priority date: 2015-06-19
Filing date: 2015-06-19
Publication date: 2016-12-22

Abstract

An interspinous stabilizer comprises a first fixing portion (1), a second fixing portion (2), and an elastic portion (3). The first fixing portion (1) is connected to the second fixing portion (2) by means of the elastic portion (3), the first fixing portion (1), the second fixing portion (2) and the elastic portion (3) jointly define a hollow-out structure (C). The interspinous stabilizer has the following advantages: the demands of physiological activities of a human body are fully considered, activities in all directions are matched to the greatest extent, the interspinous stabilizer is integrally formed, and the problem of relative displacement or loosening and drop of stabilizing structures is not caused; the interspinous stabilizer has proper structural design, a small size, stable fixation and small damage and facilitates postoperative recovery of a patient; the interspinous stabilizer is simple and convenient to operate in the operation process, and reduces operation difficulties and risks.

Description

Interspinous stabilizer

Technical field

The invention relates to a medical device built in a human body, and in particular to a interspinous stabilizer for dynamic fixation of a cervical and lumbar spine.

Background technique

At present, spinal fusion technology has achieved good results in the treatment of low back pain and cervical and lumbar instability, and the fusion rate is over 90%. However, studies have shown that its clinical efficacy has not reached the expected value; and strong internal fixation and spinal fusion have the potential to accelerate complications such as adjacent segment degeneration, internal fixation failure, and postoperative pseudoarthrosis. In view of this, dynamic fixation of the cervical and lumbar spine is becoming a popular technique for the treatment of degenerative cervical and lumbar diseases in recent years, including artificial total disc replacement, artificial nucleus replacement, transpedicular dynamics, dynamic fixation between spinous processes, and facet joint formation. There are five types of devices. Among them, the dynamic fixation between the spinous processes is the smallest, the safety is the highest, the operation is the simplest, the complications are slight, and even if the failure does not affect its further surgical treatment, it develops rapidly.

The implantation of the interspinous internal fixation system has the following advantages: it can be dynamically fixed without sacrificing the immediate stability of the spine, and the post-distribution of the rigid internal fixation load can be dispersed to avoid stress shielding and the expansion between the spines. The force can produce relative kyphosis in the surgical segment, so that the inflection of the ligamentum flavum can be reversed to reduce its invasion of the spinal canal, increase the volume of the spinal canal, restore the height of the intervertebral space, and increase the spinal canal and intervertebral space. The area of the hole, the load of the rear fiber ring is unloaded, and the small joint load of the corresponding segment is reduced, and the postoperative patient recovers rapidly, the recurrence rate is low, the symptoms such as pain are relieved, and the patient can get out of bed early and resume daily life.

However, there are still many defects in the existing interspinous dynamic internal fixator.

For example, the Coflex system designed and supplied by Samani in 1994 has a "U" shape from the side, and two "clip" fixed wing structures (one front and one rear) at the upper and lower ends of the U-shaped main structure. Clamping the superior and inferior spinous processes allows simultaneous use between the spinous processes of adjacent consecutive segments; however, the system must remove the supraspinous and interspinous ligaments during surgery and provide only sagittal flexion and extension. The Chinese utility model patent (patent number: ZL201020247832.0) discloses a "spine non-fusion fixation device" which has substantially the same structure as the Coflex system, in particular, in the solution of the utility model patent, U-shaped The part 1 corresponds to the U-shaped main structure of the Coflex, and the front and rear fixing plates 2 of the fixing portion correspond to the two "clip-shaped" fixed wing structures of the Coflex, and the front and rear fixing plates 2 are respectively fixed to the adjacent two by screws. a spinous process, thereby achieving the fixation of the U-shaped main structure, but as mentioned above, this structure can only achieve the sagittal extension and flexion, that is, the deformation of the U-shaped structure changes the size of the U-shaped opening, thereby The opening and closing direction cooperates with the change in the distance between the spinous processes (interspinous).

The Chinese invention patent application (Application No. 201210005705.3) filed by the inventor of the present invention discloses a "spindle universal dynamic stabilizer", but the structure is too large in the technical solution; vertical spinous processes are required in the operation operation Fixing in the lateral direction, the operation is difficult, and it is easy to cause fracture and damage; the U-shaped structure is horizontal, and the physiological activity of the lumbar spine is not consistent with the direction of extension and flexion, and can not meet the physiological activity requirements of human body. The lateral activity is too large, adding new factors of lumbar instability. Another Chinese invention patent application filed by the inventor of the present invention (Application No.: 201410021613.3) discloses a "universal dynamic stabilizer for the inter-plate type", but the U-shaped structure of the solution needs to be fixed by a plug-in board. It is inconvenient to operate, the fixing is relatively unstable, and it is easy to cause looseness of the fixed structure; if the activity is too large, the fixing device may be less stable.

The activities of the human spine include flexion and extension in the sagittal position, lateral bending in the left and right direction, rotation in the coronal position, and a general rotation in multiple directions, but the movement of the spine in different directions is not equal. If the flexion activity is significantly greater than the extension mobility, the activity in the anteroposterior direction is also greater than the lateral mobility. Other existing interspinous dynamic internal fixator programs are difficult to match the physiological activity patterns of the human spine, and some can only move in one direction, and some stresses tend to concentrate on somewhere to cause the prosthesis to break. The height of the prosthesis and the height of the spinous process are required to sacrifice the supraspinous ligament during operation. Some prostheses and spinous processes cause wear and tear, or some use the binding band for long-term fixation and easy relaxation. It is difficult to guarantee very low complications. Very good long-term effect.

Summary of the invention

In order to solve one of the above problems, according to an aspect of the present invention, a spine stabilizer is provided, including: a first fixing portion, a second fixing portion, and an elastic portion, wherein the first fixing portion passes through the elastic portion and the first portion The two fixing portions are connected, and the first fixing portion, the second fixing portion and the elastic portion collectively define a hollow structure.

According to an embodiment of the present invention, optionally, the elastic portion includes: a first elastic structure, the first fixing portion, comprising: a first pinch structure and a first opening and closing structure, wherein the first opening and closing structure and the first The elastic structure is connected to the root of the first pincer structure, and the second fixing portion includes: a second pincer structure and a second opening and closing structure, wherein the second opening mechanism and the first elastic structure are both connected to the second pliers The root of the structure, wherein the first opening and closing mechanism, the root of the first pincer structure, the second opening and closing mechanism, the root of the second pincer structure, and the elastic portion collectively define a hollow structure.

According to an embodiment of the invention, optionally, the elastic portion comprises a spring, the two ends of which are respectively connected to the first elastic structures on both sides.

In accordance with an embodiment of the present invention, optionally, the resilient portion includes a second resilient structure that primarily provides elasticity in the sagittal direction of the spine, secondary to providing flexibility in the scoliosis or rotational direction of the spine.

According to an embodiment of the invention, optionally, the second resilient structure comprises a continuous U-shaped structure.

According to an embodiment of the invention, optionally, the continuous U-shaped structure comprises two consecutive U-shaped portions, the two U The shaped portions share adjacent edges.

According to an embodiment of the invention, optionally, the continuous U-shaped structure comprises three consecutive U-shaped portions, the adjacent two U-shaped portions sharing adjacent sides, wherein the opening direction of the two U-shaped portions is combined with another U The opening of the shaped portion is opposite in direction.

According to an embodiment of the invention, optionally, the second elastic structure is composed of a continuous U-shaped structure comprising three consecutive U-shaped portions, each adjacent two U-shaped portions sharing adjacent sides, wherein The two sides of the three continuous U-shaped structures are respectively connected to the first elastic structures on both sides and form a V-shaped structure.

According to an embodiment of the present invention, optionally, the elastic portion further includes a third elastic structure that mainly provides elasticity of the side bend in the left and right direction of the spine. Alternatively, the opening directions of the two U-shaped portions are the same or opposite.

According to an embodiment of the invention, optionally, the second elastic structure and the third elastic structure are constituted by a continuous U-shaped structure comprising three consecutive U-shaped portions, each adjacent two U-shaped portions being shared An adjacent side, wherein the second elastic structure includes two U-shaped portions, the third elastic structure includes a U-shaped portion, and the two U-shaped portions of the second elastic structure are on both sides of the U-shaped portion of the third elastic structure, and The opening direction of the two U-shaped portions of the second elastic structure is the sagittal direction of the spine, and the opening directions of the two U-shaped portions are opposite; the opening direction of the U-shaped portion of the third elastic structure is the lateral bending direction of the spine.

According to an embodiment of the invention, optionally, a detachment prevention hook is provided at the bottom of the first opening and closing structure and/or the second opening and closing structure.

According to an embodiment of the invention, optionally, a jaw is provided on the inside of the first pinch structure and/or the second pinch structure.

According to an embodiment of the invention, optionally, a semi-circular screw hole is provided inside the first pinch structure and/or the second pinch structure.

According to an embodiment of the invention, optionally, a locking screw hole is further provided in the first pinch structure and/or the second pinch structure.

According to an embodiment of the invention, an adjustment slit is optionally provided on the outside of the first pincer structure and/or the second pincer structure.

According to an embodiment of the present invention, optionally, the front and rear sides of the interspinous stabilizer are a structure in which both sides are flat, or a structure in which one side is a plane and the other side is a curved surface, or a structure in which the front and back are curved surfaces. .

According to an embodiment of the invention, optionally, the interspinous stabilizer is made using a biomedical polymeric material and/or a biomedical metallic material.

According to an embodiment of the present invention, optionally, the biomedical polymer material comprises one or more of the following: polyethylene; polymethyl methacrylate; biodegradable polymer material, including polylactic acid, chitin; Peek material The biomedical metal material comprises one or more of the following: medical stainless steel, including Fe-1 8Cr-14Ni-3Mo; cobalt-based alloy; titanium-based alloy, including Ti-6AL-4V; shape memory alloy, including nickel-titanium memory alloy ;钽;铌.

According to an embodiment of the present invention, optionally, the interspinous stabilizer has a total length of 8-60 mm; the inner gap of the opening: 4-16 mm; the height of the U-shaped structure: 6-25 mm; the thickness of the U-shaped structural plate: 0.4-3 mm; Width: 6-40mm.

According to an embodiment of the invention, optionally, the total length of the interspinous stabilizer is 35-55 mm.

According to an embodiment of the invention, optionally, the intra-opening gap of the interspinous stabilizer is 6-16 mm.

According to an embodiment of the invention, optionally, the first fixation portion and/or the second fixation portion of the interspinous stabilizer, the elastic portion of the interspinous stabilizer or the interspinous stabilizer are integrally formed.

According to an embodiment of the invention, optionally, the interspinous stabilizer is bilaterally symmetrical.

According to an embodiment of the invention, optionally, the first elastic structure primarily provides a rotational movement of the coronal position.

The interspinous stabilizer according to the embodiment of the present invention may have one or more of the following effects: full consideration of the needs of human physiological activities, the degree of activity in all directions can be given the greatest degree of matching; It will cause relative displacement or loosening between stable structures; reasonable structural design, small size, but stable and stable, and small damage, which is conducive to postoperative recovery; easy operation during surgery, reducing the difficulty and risk of surgery.

DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings of the embodiments will be briefly described below. It is obvious that the drawings in the following description relate only to some embodiments of the present invention, and are not intended to limit the present invention. .

Figure 1 is a front elevational view of a stray stabilizer in accordance with one embodiment of the present invention;

Figure 2 is a left side sectional view of the interspinous stabilizer shown in Figure 1;

Figure 3 is a left side sectional view showing a modification of the interspinous stabilizer shown in Figure 1;

Figure 4 is a front elevational view of a spine stabilizer in accordance with another embodiment of the present invention;

Figure 5 is a left side sectional view of the interspinous stabilizer shown in Figure 4;

Figure 6 is a left side cross-sectional view of the interspinous stabilizer of a variation of the interspinous stabilizer shown in Figure 4;

Figure 7 is a schematic illustration of a spine stabilizer in accordance with yet another embodiment of the present invention;

Fig. 8 is a photograph schematically showing an effect of mounting a spine stabilizer on a human skeleton according to an embodiment of the present invention;

The photograph of Fig. 9 schematically shows the effect of mounting the interspinous stabilizer according to the prior art on a human skeleton;

Fig. 10 schematically shows a spine stabilizer according to still another embodiment of the present invention.

Reference numeral

1 first fixing portion; 11 clamp structure; 111 clamp teeth; 112 semicircular screw holes; 113 locking screw holes; 12 opening and closing structure; 121 anti-unhook; 2 second fixing portion; 21 clamp structure; ; 212 semicircular screw hole; 213 locking screw hole; 22 opening and closing structure; 221 anti-decoupling; 3 elastic portion; 31 first elastic structure; 32 second elastic structure; 33 third elastic structure; 3a spring; 4 adjustment joint; C hollow structure; V auxiliary elastic structure.

detailed description

The technical solutions of the embodiments of the present invention will be clearly and completely described in the following with reference to the accompanying drawings. It is apparent that the described embodiments are part of the embodiments of the invention, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the described embodiments of the present invention without departing from the scope of the invention are within the scope of the invention.

Unless otherwise defined, technical terms or scientific terms used herein shall be taken to mean the ordinary meaning of the ordinary skill in the art to which the invention pertains. The words "first", "second" and similar terms used in the specification and claims of the present invention do not denote any order, quantity, or importance, but are merely used to distinguish different components. Similarly, the words "a" or "an" and the like do not denote a quantity limitation, but mean that there is at least one.

The interspinous stabilizer according to the embodiment of the present invention extends along the extending direction of the spine, and the fixing structures at both ends thereof are respectively fixed to the two adjacent spinous processes, and are integrally installed in the gap between the two adjacent spinous processes, As shown in Fig. 8, in this way, the bone biting area has less excision of the spinous process bone. For the Coflex program, the stabilizer is embedded in two adjacent spinous processes, and the spinous process bone resection is more (as shown in Fig. 9). Relative to Coflex, the stabilizer according to the embodiment of the present invention has a shorter rotational force arm acting on the spinous process, that is, the rotational force mainly acts on the root of the spinous process, thereby reducing the risk of spinous process fracture when the lumbar spine is rotated, specifically In other words, the distance indicated by the double arrow in FIG. 8 is the rotational force arm of the stabilizer acting on the spinous process, and the distance indicated by the double arrow in FIG. 9 is the rotational force arm of the stabilizer under the Coflex scheme acting on the spinous process. Such a long rotating arm may cause the position shown by the single arrow in Fig. 9 to break due to stress tending to concentrate on the flanking root. In addition, compared with the height of 25 to 30 mm of Coflex, the stabilizer of the present invention can have a total height of about 6 to 12 mm, which is much smaller than the height of coflex, so that the supraspinous ligament is not stimulated after installation, and is better. The supraspinous ligament is preserved, and coflex often requires removal of the supraspinous ligament. Even if the supraspinous ligament is not removed, frequent stimulation of the supraspinous ligament may occur after surgery; it is not required to be close to the dura mater, and there is no artificial change of the sagittal position of the spine. Rotation center; lower requirements for spine height, spine spacing, and lumbosacral angle, while coflex is the opposite. When the spine spacing is small, the spinous processes are short, and the lumbosacral angle is large, it is not suitable for installation. Furthermore, the stabilizer of the present invention can be moved in all directions after being installed on the bone, and Coflex can only move in one direction, which greatly limits the physiological activities of the human body.

1 is a front cross-sectional view of a spine stabilizer according to an embodiment of the present invention, and FIG. 2 is a left side cross-sectional view of the interspinous stabilizer shown in FIG. 1.

As shown in FIG. 1, the interspinous stabilizer includes a first fixing portion 1, a second fixing portion 2, and an elastic portion 3. The first fixing portion 1 and the second fixing portion 2 are connected by the elastic portion 3 . Since the size and shape of the upper and lower spinous processes are inconsistent, the first fixing portion 1 and the second fixing portion 2 may have an asymmetrical structure, which is also advantageous for better matching with the spinous process bone. Can Ground selection, depending on the application, a symmetrical structure can also be used.

Specifically, the first fixing portion 1 has a pincer structure 11 having an upward or downward opening for holding the spinous process; the pinch structure 11 is passed through the U-shaped or V-shaped opening and closing structure 12. The two parts are joined together, and the opening size of the pincer structure 11 is adjusted by the elastic opening and closing ability (opening and recovery ability) of the opening and closing structure 12 itself, thereby achieving the clamping of the spinous processes. As shown in FIG. 1, the opening and closing mechanism 12 is coupled to the root of the clamp structure 11.

Alternatively, the pincer structure 11 and the opening and closing structure 12 are integrally formed solid structures. That is to say, the two parts are solid structures and are integrally formed. Compared with the matching structure of the inner metal plate and the outer metal plate of the Chinese invention patent application 201210005705.3, the integrally formed solid structure is smaller, simpler, more durable and more complicated to process; Compared with the cooperation scheme of the plug-in board, the U-shaped structure of the patent application 201410021613.3 is simpler, more durable, and has a better clamping and fixing effect.

As described above, the second fixing portion 2 may adopt a structure that is not completely symmetrical with the first fixing portion 1, but may similarly have the pinch-like structure 21 and the opening and closing structure 22. Alternatively, the second fixing portion 2 may also have the same structure and/or shape as the first fixing portion 1.

The first fixing portion 1 and the second fixing portion 2 are for fixing the stabilizer and the spinous process, and the elastic portion 3 is for enabling the stabilizer to achieve flexion, extension, left and right side bending and rotation in the sagittal position. Elastic activities in all directions, which assist in the realization of the movement of the spine in all directions and the elastic dynamic stability of the activities in all directions.

Specifically, the elastic portion 3 may include a first elastic structure 31, a second elastic structure 32, and a third elastic structure 33, wherein the first elastic structure 31 mainly provides rotational elasticity, and the second elastic structure 32 mainly provides sagittal position. The elasticity in the forward flexion and the extension direction, the third elastic structure 33 mainly provides elasticity in the left and right lateral bending directions in the coronal position. The combination of the first elastic structure 31, the second elastic structure 32, and the third elastic structure 33 can provide motion in various directions such as flexion, extension, left and right side bending, and rotation in the sagittal position.

As can be seen from the above description and FIG. 1 , the first elastic structure 31 is respectively connected to the root of the pincer structure 11 of the first fixing portion 1 and the root of the pincer structure 21 of the second fixing portion 2, so that the elastic portion 3 and the first portion respectively A fixing portion 1 and a second fixing portion 2 are connected. The first elastic structure 31 can provide rotational elasticity when relative rotation occurs between the first fixed portion 1 and the second fixed portion 2, or when adjacent spinous processes of the implanted interspinous stabilizer are relatively rotated.

The second elastic structure 32 may include a U-shaped portion, for example, including two U-shaped portions, as shown in FIGS. 1 and 8, the two U-shaped portions of the second elastic structure 32 are perpendicular to the paper direction of FIG. Thereby providing an extension and flexion activity in the sagittal position after implantation.

The third elastic structure 33 may also be a U-shaped structure, but the opening direction of the U-shaped structure is parallel to the paper surface direction of Fig. 1, thereby providing a side bend in the left-right direction of the spine when in use.

Thus, from Fig. 1, in the direction perpendicular to the paper surface of Fig. 1, it can be seen that a U-shaped opening of the second elastic structure 32 is upward (with respect to the paper facing outward), and a U-shaped opening is downward (relative to the paper facing) 1 is a cross-sectional view, and the model photograph in FIG. 8 is seen more clearly; from both FIG. 1 and FIG. 2, the opening of the U-shaped portion of the third elastic structure 33 can be seen, and the opening direction of the third elastic structure 33 is stabilized. The outside.

As can be seen in conjunction with Figures 1, 2 and 8, the second elastic structure 32 and the third elastic structure 33 can be combined, and more specifically, the three U-shaped portions of the second elastic structure 32 and the third elastic structure 33 can be constructed. Integral, it becomes a continuous U-shaped structure in which two U-shaped portions of the second elastic structure 32 are located on both sides of the U-shaped portion of the third elastic structure 33, and adjacent U-shaped portions have a common side. The three U-shaped portions of the second elastic structure 32 and the third elastic structure 33 may be integrally formed in the above manner by being connected to each other, or may be integrally formed. If a one-piece solid structure is used, the elastic portion 3 can be made more durable and can provide greater stress. This is very significant for the elastic portion 3 which often bends in all directions.

Optionally, as shown in FIG. 1 and FIG. 8, the stabilizer according to the embodiment of the present invention has an elastic portion 3 which is an integrally formed solid structure, that is, the first elastic structure 31 and the second elastic structure 32 described above. The third elastic structure 33 is integrally formed. This one-piece solid structure is slightly more complicated than the single U-shaped continuous U-shaped structure in the Chinese invention patent application 201210005705.3, but the structure fully considers the needs of human physiological activities, and the activity in all directions can give Maximum match with spinal activity. This is because, in the demand of human physiological activities, flexion and extension are the most commonly used movements, and their flexion activity is significantly greater than that of the extension and lateral bending. Therefore, the front and rear - left and right - front and rear continuous U shape is adopted. The structure can, on the one hand, take into account that the curvature of the flexion is larger than the curvature of the side curve and the frequency of the pitch is higher, on the other hand, the movement in other directions before and after and left and right can be better realized; The elasticity provided by the connected part (the first elastic structure) can respectively design and realize the activities of flexion, extension, lateral bending and rotation in all directions, so as to have a high matching with the physiological activity pattern of the human spine. Sexuality, and the structure also guarantees a certain degree of stability on the basis of fully satisfying the above requirements. In addition, the integrally formed structure does not cause relative displacement or loosening between components.

Alternatively, the second elastic structure of the elastic portion 3 and the three continuous U-shaped structures of the third elastic structure may also be a combination of left and right - front to back - left and right. In addition, the second elastic structure and the third elastic structure of the elastic portion 3 may also be more than three continuous U-shaped structures, such as five. In five consecutive U-shaped structural solutions, front-rear-left-right-front and rear - Left and right - front and rear, or left and right - front to back - left and right - front to back - left and right, although the structure of the elastic portion 3 is increased in complexity, its elasticity will be improved, and treatment and rehabilitation for the patient will be better.

Further, since the amplitude of the left and right side bends is small, it is also possible to use the second elastic structure 32 to bend in the front, rear, left and right directions. In this case, the second elastic structure 32 may be two continuous U-shaped structures. Approximate "S" shape; or, it may be three continuous U-shaped structures, in an approximate "W" shape, as shown in FIG.

The stabilizer shown in Fig. 10 includes only the first elastic structure 31 and the second elastic structure 32 having three continuous U-shaped structures. As described above, the three continuous U-shaped structures mainly provide the sagittal orientation of the spine. Elasticity, but it is also possible to provide a part of the elasticity of the spine in the left-right direction (coronal direction) and the direction of rotation; and as shown in Fig. 10, the two sides of the three continuous U-shaped structures respectively form an approximation to the first elastic structure 31. A "V" shaped structure (indicated by "V" in the figure), which provides a certain elasticity in the left and right direction of the spine.

For the above three continuous U-shaped structures, it is also possible to adopt a combination of two U-shaped partial openings in the vertical direction and a U-shaped partial opening forward in the vertical direction, so that it can better conform to most of the human body. Exercise is the current state of physiological demand for flexion. For a solution without the third elastic structure 33, the continuous U-shaped structure may also include more than three U-shapes that share adjacent sides.

As shown in FIG. 1, the elastic portion 3 corresponds to the structures of the first fixing portion 1 and the second fixing portion 2, and also has a bilaterally symmetrical structure.

As shown in FIG. 1, the first elastic structure 31 on the side of the first fixing portion 1 and the opening and closing structure 12 of the first fixing portion 1 are both connected to the root of the clamp structure 11, and are located on the side of the second fixing portion 2. The first elastic structure 31 and the opening and closing structure 22 of the second fixing portion 2 are both connected to the root of the clamp structure 21, thereby forming a hollow structure C. On the one hand, when the interspinous stabilizer is implanted into the human body, the hollow structure C can be inserted into the hollow structure C and spread outward, the interspinous stabilizer is inserted into the interspinous space, and then the distractor is taken out, and the elasticity of the fixing portion is utilized. The retraction causes the fixing

portions

1 and 2 to be fixed to the upper and lower spinous processes to complete the installation; on the other hand, the hollow structure C can further provide elasticity so that the stabilizer can move and stabilize in all directions as a whole.

Optionally, the bottom of the opening and closing structure 12 and/or the opening and closing structure 22 of the interspinous stabilizer according to the present invention has an anti-decoupling (121, 221) that can be used for hooking on the spinous process to prevent the first fixing portion 1 from being And/or the second fixing portion 2 slips back. Further, in order to prevent the detachment hook from being weak, the spinous process may alternatively be appropriately trimmed.

Optionally, jaws (111, 211) are provided on the inner side of the pincer structure 11 and/or the pincer structure 21 of the interspinous stabilizer according to the present invention, and the spinous process bone can be partially embedded in use, thereby reinforcing the pair The fixing function of the stabilizer. The jaws may also be disposed on the inside of the opening and closing structure 12 and/or the opening and closing structure 22, or alternatively, the jaws may be disposed on the inside of the jaw structure and the opening and closing structure.

Optionally, a semicircular screw hole (112, 212) is provided inside the pincer structure 11 and/or the pinch structure 21 of the interspinous stabilizer according to the present invention, into which a screw can be screwed (not shown) ), one half of the screw is screwed into the semi-circular screw hole, and the other half is in contact with the spinous process and can be partially embedded in the bone to further secure the stabilizer to the spinous process.

In addition, optionally, the pincer structure 11 and/or the pincer structure 21 of the interspinous stabilizer according to the present invention are further provided with Locking the screw hole (113, 213) into which a locking bolt (not shown) can be screwed, and the screw of the locking bolt is pressed against the screw screwed into the semicircular screw hole to prevent the screw from being inserted into the semicircular screw hole The screw is pulled out.

4 and 5 illustrate a stray stabilizer in accordance with another embodiment of the present invention. Unlike the embodiment shown in Fig. 1, in the embodiment of Figs. 4 and 5, the second elastic structure 32 and the third elastic structure 33 of the elastic portion 3 are realized by the spring 3a. Both ends of the spring 3a are respectively connected to the first elastic structures 31 on both sides, as shown in FIG. Since the bending of the spring itself has no directional restriction, the movement in all directions can be easily achieved. As shown in Fig. 4, the hollow structure C is enclosed by the opening and closing structure 12/22, the first elastic structure 31, a portion of the root of the pincer structure 11/21, and the spring 3a.

The front and rear sides of the interspinous stabilizer according to the embodiment of the present invention can be made into a structure in which both sides are flat, and can also be formed into a structure in which one side is a plane and the other side is a curved surface, as shown in FIG. 3 and FIG. It is a structure with curved faces on both sides.

Figure 7 is a schematic side cross-sectional view of a spine stabilizer in accordance with yet another embodiment of the present invention. Compared with the previous embodiment, the interspinous stabilizer shown in FIG. 7 is provided with an adjustment slit 4 (shown by a vertical dotted line) on the outer side of the clamp structure 11/21 for the first fixing portion. 1 and fine adjustment of the relative angle of the second fixing portion 2 in the vertical direction (the longitudinal movement direction of the sagittal position), so that the angular difference between the first fixing portion 1 and the second fixing portion 2 in the vertical direction due to the mounting can be compensated for , reducing or eliminating the effects of internal stress caused by the angular difference. The process of implanting the interspinous stabilizer into the human body according to an embodiment of the present invention will be briefly described below.

When the interspinous stabilizer is implanted in the human body of degenerative lumbar disease, the superior ligament of the spine can be cut, all or part of the interspinous ligament can be removed, and the superior and inferior spinous processes can be retracted to increase the distance between the spines. After successful trial, the expander is used. Inserting the inner surface of the hollow structure into the outer opening, inserting the interspinous stabilizer into the interspinous space, taking out the distractor, and fixing the fixing plate to the upper and lower spinous processes by elastic retraction of the fixing plate material, thereby completing the installation; If it is not proper, it can be reinforced by semi-circular screw holes and locking screws on both sides of the first fixing portion and the second fixing portion opening (opening and closing structure), and the anti-detaching hook at the bottom of the opening is hooked on the spinous process. The first fixing portion and the second fixing portion are prevented from slipping backward, and the spinous process can be appropriately trimmed in order to prevent the unhooking hook from being unstable. At the same time, the upper teeth of the semicircular screw hole in the opening are also hooked on the spinous process to further fix the interspinous stabilizer. After fixing the interspinous stabilizer and the spinous process, the supraspinous ligament is finally sutured to complete the installation.

The interspinous stabilizer can realize the elastic expansion between the spine and the lateral flexion of the spine through the deformation of the elastic portion and the hollow structure, and realize the flexion, the extension, the left and right side bending and the rotation of the surgical segment in the sagittal position. The elastic activity of the direction; the operation time is short, the intraoperative injury is small, and the postoperative body recovers quickly.

The interspinous stabilizer according to an embodiment of the present invention may be made of a biomedical polymer material, a biomedical metal material, or both. The biomedical polymer material may include one or more of the following: polyethylene, polymethyl methacrylate (PMMA), biodegradable polymer material (polylactic acid, chitin), Peek material; biomedical metal material The material may include one or more of the following: medical stainless steel (typical alloy is Fe-1 8Cr-14Ni-3Mo), cobalt-based alloy, titanium-based alloy (the most commonly used titanium alloy is titanium-6-aluminum-vanadium (Ti- 6AL-4V)), shape memory alloy (nickel-titanium memory alloy); tantalum, niobium, among which, titanium alloy is preferred, easy to produce and small in rejection reaction, and pure titanium and stainless steel are also preferred.

The interspinous stabilizer according to an embodiment of the present invention may be integrally formed as a solid structure as a whole.

The interspinous stabilizers according to embodiments of the present invention may be of different gauge sizes for different applications or objects, for example, total length: 8-60 mm, preferably, range 35-55 mm, more suitable for the elderly Human skeleton; opening (clamp structure) internal gap: 6-16mm, preferably, range 8-15mm, more suitable for most people's bones; U-shaped structure height: 6-25mm; U-shaped structural plate thickness: 0.4-3mm, a certain thickness can guarantee a certain stability; width: 6-40mm, can be considered to match the gap in the opening.

The interspinous stabilizer according to the embodiment of the present invention may have one or more of the following effects: fully considering the physiological physiological activity of the human body, the activity in all directions can give the greatest matching of the physiological activity of the spine. One-piece molding does not cause relative displacement or loosening between stable structures; reasonable structural design, small size, but stable and stable, and small damage, which is conducive to postoperative recovery; easy operation during surgery, reduced surgery Difficulties and risks.

The above is only an exemplary embodiment of the present invention, and is not intended to limit the scope of the present invention. The scope of the present invention is defined by the appended claims.

Claims

A spine stabilizer includes: a first fixing portion (1), a second fixing portion (2) and an elastic portion (3), wherein the first fixing portion (1) passes through the elastic portion (3) Connecting with the second fixing portion (2), wherein the first fixing portion (1), the second fixing portion (2) and the elastic portion (3) together define a hollow structure (C) ).
The interspinous stabilizer according to claim 1, wherein the elastic portion (3) comprises: a first elastic structure (31), and the first fixing portion (1) comprises:

a first pincer structure (11) and a first opening and closing structure (12), wherein the first opening and closing structure (12) and the first elastic structure (31) are both connected to the first pinch structure a root portion of (11), the second fixing portion (2), comprising: a second pincer structure (21) and a second opening and closing structure (22), wherein the second opening and closing mechanism (22) and the The first elastic structure (31) is connected to the root of the second pincer structure (21), wherein the first opening and closing mechanism (12), the root of the first pincer structure (11), The second opening and closing mechanism (22), the root of the second pincer structure (21), and the elastic portion (3) collectively define the hollow structure (C).
The interspinous stabilizer according to claim 2, wherein the elastic portion (3) comprises a spring (3a), and the two ends of the spring (3a) are respectively connected to the first elastic structures on both sides (31) ).
The interspinous stabilizer according to claim 2, characterized in that the elastic portion (3) comprises a second elastic structure (32) mainly providing elasticity in the sagittal direction of the spine.
The interspinous stabilizer of claim 4 wherein said second resilient structure (32) comprises a continuous U-shaped structure.
The interspinous stabilizer of claim 5 wherein said continuous U-shaped structure comprises two consecutive U-shaped portions that share adjacent sides.
The interspinous stabilizer according to claim 6, wherein the opening directions of the two U-shaped portions are the same or opposite.
The interspinous stabilizer according to claim 5, wherein said continuous U-shaped structure comprises three consecutive U-shaped portions, adjacent two U-shaped portions sharing adjacent sides, wherein two U-shaped portions The opening direction is opposite to the opening direction of the third U-shaped portion.
The interspinous stabilizer according to claim 4, wherein said second elastic structure (32) is constituted by a continuous U-shaped structure comprising three consecutive U-shaped portions, each adjacent to two The U-shaped portions share adjacent sides, wherein the two sides of the three consecutive U-shaped structures are respectively connected to the first elastic structures (31) on both sides and form a V-shaped structure.
The interspinous stabilizer according to claim 4, characterized in that the elastic portion (3) further comprises a third elastic structure (33) mainly providing elasticity in the left-right direction of the spine.
The interspinous stabilizer according to claim 10, wherein said second elastic structure (32) and said third elastic structure (33) are composed of a continuous U-shaped structure, and said continuous U-shaped structure comprises three a continuous U-shaped portion, each adjacent two U-shaped portions sharing an adjacent side, wherein the second elastic structure (32) comprises two U-shaped portions, and the third elastic structure (33) comprises a U-shaped portion Part, two U-shaped portions of the second elastic structure (32) are on both sides of the U-shaped portion of the third elastic structure (33), and two U-shaped portions of the second elastic structure (32) The opening is in the sagittal direction of the human body; the opening of the U-shaped portion of the third elastic structure (33) is in the left-right direction of the spine.
The interspinous stabilizer according to claim 2, wherein a detachment preventing hook is provided at a bottom of the first opening and closing structure (12) and/or the second opening and closing structure (22) (121, 221) ).
The interspinous stabilizer according to claim 2, characterized in that the inside of the first pincer structure (11) and/or the second pincer structure (21) is provided with jaws (111, 211) ).
The interspinous stabilizer according to claim 2, characterized in that a semicircular screw hole is provided inside the first pincer structure (11) and/or the second pincer structure (21) ( 112,212).
The interspinous stabilizer according to claim 14, characterized in that the first pincer structure (11) and/or the second pincer structure (21) are further provided with a locking screw hole (113, 213). ).
The interspinous stabilizer according to claim 2, characterized in that an adjustment slit (4) is provided outside the first pincer structure (11) and/or the second pincer structure (21).
The interspinous stabilizer according to claim 1, wherein the front and rear sides of the interspinous stabilizer are a structure in which both sides are flat, or a structure in which one side is a plane and the other side is a curved surface, or both sides are It is a curved surface structure.
The interspinous stabilizer according to claim 1, wherein the interspinous stabilizer is made of a biomedical polymer material and/or a biomedical metal material.
The interspinous stabilizer according to claim 18, wherein the biomedical polymer material comprises one or more of the following: polyethylene; polymethyl methacrylate; biodegradable polymer material, including poly Lactic acid, chitin; Peek material, the biomedical metal material comprises one or more of the following: medical stainless steel, including Fe-18Cr-14Ni-3Mo; cobalt-based alloy; titanium-based alloy, including Ti-6AL-4V; shape Memory alloys, including nickel-titanium memory alloys; 钽; 铌.
The interspinous stabilizer according to claim 1, wherein the interspinous stabilizer has a total length of 8-60 mm; the inner gap of the opening: 6-16 mm; the height of the U-shaped structure: 6-25 mm; a U-shaped structure Plate thickness: 0.4-3mm; width: 6-40mm.
The interspinous stabilizer of claim 20, wherein the interspinous stabilizer has a total length of 35-55 mm.
The interspinous stabilizer according to claim 20, wherein the intersticcular space of the interspinous stabilizer is 6-16 mm.
The interspinous stabilizer according to any one of claims 1 to 22, wherein the first solid of the interspinous stabilizer The fixed portion (1) and/or the second fixed portion (2), the elastic portion (3) of the interspinous stabilizer or the interspinous stabilizer are integrally formed.
The interspinous stabilizer according to any one of claims 1 to 22, wherein the interspinous stabilizer is bilaterally symmetrical.
The interspinous stabilizer according to any one of claims 2 to 16, characterized in that the first elastic structure (31) mainly provides a rotational movement of the coronal position.