IMPLANT FOR THE INTERVERTEBRAL DISC SPACE FOR TREATING SCOLIOSIS, KYPHOSIS, STENOSIS AND FRACTURES OF THE SPINAL COLUMN

Abstract

Disclosed is an implant for the intervertebral disc space, for the treatment of scoliosis, kyphosis, stenosis and fractures of the spinal column, which comprises a substantially cylindrical, inflatable, flexible, biocompatible element that has a morphology dependent on the problem to be treated and is suitable for insertion into the intervertebral disc space. The implant can be inflated using an external pressure system in order to allow the injured disc to be lifted, and it can be filled with a material (2) which, once solidified, has an elastic hardness similar to that of a healthy intervertebral disc at the vertebral level in which the implant is to be inserted, said elastic hardness being higher in the area of the lumbar vertebrae and lower in the dorsal or cervical area.

Claims

1. An implant for an intervertebral disc space for treatment of scoliosis, kyphosis, stenosis and fractures of a spinal column, comprising: a substantially cylindrical, inflatable, flexible, biocompatible element (1) suitable for insertion into the intervertebral disc space between intervertebral discs of the spinal column and configured to be inflated by an external pressure system in order to allow an injured disc of the spinal column to be lifted, the biocompatible element comprising: bases (11) and a perimeter envelope (12) defining a space (13) configured to be filled with a material (2); wherein at least one of said bases (11) is rigid or semi-rigid and both bases (11) have a perimeter morphology dependent on the treatment and the perimeter envelope (12) is configured to be flexible such that a height of the biocompatible element (1) is determined by a separation that exists between the intervertebral discs once said biocompatible element (1) is inflated; and wherein when the space (13) of the biocompatible element (1) is filled with the material (2) which, once solidified, has an elastic hardness similar to that of a healthy intervertebral disc.

2. The implant according to claim 1, wherein when the space (13) of the biocompatible element is filled internally, the perimeter envelope (12), once inflated, acquires a height similar to that of the intervertebral disc, such that both bases (11) are semi-rigid and morphology of the bases corresponds to an irregular section in which at least one area (15) has a shape of a circular sector, which has a larger contact surface in an area of an annulus fibrosus (5) that must be lifted to repair vertebral deformities such as degenerative scoliosis, kyphosis, anterior vertebral imbalances and spondylolisthesis.

3. The implant according to claim 1, wherein both bases (11) are semi-rigid and the perimeter envelope (12) has a central cylinder (16) and another peripheral cylinder (1), both independently inflatable and Tillable with a cement (2, 21) having equal or less elasticity in the peripheral cylinder (1) than the cement (21) that fills the central cylinder (16), such that the implant is used in cases of disc degeneration or lumbar spinal stenosis in order to increase stability of the implant and provide greater disc mobility, causing a smoother transition to the annulus fibrosus.

4. The implant according to claim 1, further comprising a biocompatible element of a preformed balloon (1) divided into two compartments: a disc-shaped compartment (18), which adapts to a vertebral endplate that is not sunken, and is filled with the material of an elastic cement having a consistency and elasticity of the intervertebral disc to be replaced, forming a semi-rigid base, and a second compartment filled with the material of a bone cement (2) that is comparable to an elasticity of an adjacent vertebrae, and which adapts to an irregular surface of a fractured vertebra, in which a second balloon (6) has been previously inserted into an vertebral body to correct a height of said vertebra, and an elastic material inserted therein which allows focal kyphosis at this level to be corrected, in the case of fracture of one of vertebral plates adjacent to the intervertebral disc.

5. The implant according to claim 1, further comprising a biocompatible element of a preformed balloon (1) inserted into an injured intervertebral disc, said preformed balloon being divided into three compartments according to substantially horizontal planes, capable of being inflated independently, wherein an intermediate compartment forms the intervertebral disc and is first filled with an elastic cement (21) having a consistency similar to that of a normal intervertebral disc, while an upper compartment and a lower compartment are filled with a cement (2) having greater or equal elasticity similar to that of an adjacent vertebrae (21) so that the preformed balloon (1) adapts at a top and internally to two irregular fractured surfaces of the adjacent vertebrae, in which respective balloons (6) have been previously placed to correct, after inflation, a height of the vertebral bodies.

6. The implant according to claim 1, further comprising radiopaque markers (17) on both bases that allow an exact location of the implant to be observed when placed between the two vertebrae.

7. The implant according to claim 1, wherein the elastic hardness of the material (2) filling the balloon (1) is between Shore 50A and Shore 90A.

8. The implant according to claim 1, wherein the material that fills the implant is a silicone, rubber, cement or any other elastic material, initially liquid or in the form of a gel, and that solidifies once injected inside of the biocompatible element (1) acquiring an elastic hardness similar to that of the healthy intervertebral disc at an vertebral level in which the implant is to be inserted.

9. Use of a balloon in an intervertebral disc space comprising: a substantially cylindrical, inflatable, flexible, biocompatible element suitable for insertion into the intervertebral disc space configured to be inflated by an external pressure system in order to allow an injured intervertebral disc to be lifted, the biocompatible element comprising: bases (11), wherein the bases (11) are rigid or semi-rigid and have an irregular perimeter section in which at least one area (15) has a shape of a circular sector, which has a larger contact surface in the an area of an annulus fibrosus (5) that must be lifted in order to repair vertebral deformities such as degenerative scoliosis, kyphosis, anterior vertebral imbalances and spondylolisthesis.

10. Use of a balloon in an intervertebral disc space comprising: a substantially cylindrical, inflatable, flexible, biocompatible element suitable for insertion into the intervertebral disc space configured to be inflated by an external pressure system in order to allow an injured intervertebral disc to be lifted, the biocompatible element comprising: bases (11) and a perimeter envelop (12), wherein both bases (11) are semi-rigid and the perimeter envelope (12) has a central cylinder (16) and another peripheral cylinder (1), both independently inflatable and fillable with cements having less or equal elasticity in the another peripheral cylinder (1) than in the central cylinder (16), in cases of disc degeneration or lumbar spinal stenosis, in order to increase the stability of an implant of the balloon and provide greater disc mobility, causing a smoother transition to an annulus fibrosus.

11. Use of a balloon in an intervertebral disc space comprising: a substantially cylindrical, inflatable, flexible, biocompatible element suitable for insertion into the intervertebral disc space configured to be inflated by an external pressure system in order to allow an injured intervertebral disc to be lifted, said balloon being internally divided into two compartments: a disc-shaped compartment (18), which adapts to an vertebral endplate that is not sunken, which will be filled with bone cement having a consistency and elasticity of a bone to be replaced, and a second compartment that is configured to be filled with an elastic cement (2) that is comparable to normal disc elasticity, which adapts to an irregular surface of a fractured vertebra, in which a second balloon (6) has been previously inserted into a vertebral body to correct a height of said fractured vertebra, and an elastic material is inserted therein, in order to repair the fracture of at least one of the vertebral plates adjacent to the intervertebral disc of the fractured vertebra.

12. Use of a balloon in an intervertebral disc space comprising: a substantially cylindrical, inflatable, flexible, biocompatible element suitable for insertion into the intervertebral disc space configured to be inflated by an external pressure system in order to allow an injured intervertebral disc to be lifted, said balloon being internally divided into three sections according to substantially horizontal planes, capable of being inflated independently, an intermediate section forming a disc that is first filled with an elastic cement (21) having an elasticity greater than or equal to a cement (2) that subsequently fills upper and lower sections in order to recover vertebral height lost after a fracture of adjacent vertebrae, in which respective balloons (6) have been previously placed to correct, after inflation, the height of the vertebral bodies.

Description

DESCRIPTION OF THE DRAWINGS

[0021] As a complement to the present description, and for the purpose of helping to make the features of the invention more readily understandable, said description is accompanied by a set of drawings which, by way of illustration and not limitation, represent the following:

[0022] FIG. 1 is a side cross-section of the implant of the invention.

[0023] FIGS. 2 and 3 show sagittal and axial sections, respectively, in an implant with the balloon (1) located and inflated in the site corresponding to the old nucleus pulposus.

[0024] FIG. 4 represents an axial cross-section of a lumbar disc from a patient with scoliosis, as shown in FIG. 5.

[0025] FIGS. 5 and 6 show an area of the spinal column with thoraco-lumbar degenerative scoliosis, respectively before and after placing the implants of the invention.

[0026] FIG. 7 shows an axial cross-section of an implant placed in a case of kyphosis with anterior vertebral imbalance or spondylolisthesis.

[0027] FIG. 8 shows a side view of a case of lumbar spinal stenosis following treatment with disc implantation of the device herein proposed.

[0028] FIG. 9 shows an implant placed in a case of a severe fracture of the L1 (Kummel) vertebra, without affecting the T12 endplate.

[0029] FIG. 10 shows an implant placed in a case of severe fracture of the L1 (Kummel) vertebra, with an associated fracture of the T12 caudal endplate.

EMBODIMENT OF THE INVENTION

[0030] The implant for the intervertebral disc space of the present invention, intended for the recovery and treatment of scoliosis, kyphosis, stenosis or fractures of the spinal column, as can be seen in FIGS. 1-3, comprises a substantially cylindrical, flexible, biocompatible balloon (1) that is suitable for insertion into the intervertebral disc space, which is provided with a connection (3) through which it can be connected with a tube (31) that allows fluid to be inserted with the help of an external pressure system, thus achieving its stabilization in the disc and disc lifting, and consequently the decompression of the injured neurological elements.

[0031] According to the invention, in this balloon (1) at least one of its bases (11) is rigid or semi-rigid and both bases (11) have a perimeter morphology dependent on the problem to be treated. For its part, the perimeter envelope (12) is flexible and its height is determined by the separation that must exist between intervertebral discs, once said balloon is inflated. In this way, the balloon (1) can be adapted to the recovery and treatment of the aforementioned conditions.

[0032] According to another important feature of the invention, the inside of said balloon (1) is filled with a material (2) which, once solidified, has an elastic hardness similar to that of the healthy intervertebral disc at the vertebral level in which the implant is to be inserted. In general, the elastic hardness of the filling material (2) of the balloon (1) is comprised between Shore 50A and Shore 90A.

[0033] In a preferential embodiment, the balloon (1) has radiopaque markers (17) on both bases that allow the exact location of said balloon to be observed when it is placed between two vertebrae (4).

[0034] The material (2) that fills the balloon (1) can be any type of elastic material that is injected in the form of liquid or gel, and solidifies once injected inside the balloon (1), acquiring the elastic hardness similar to that of the healthy intervertebral disc at the vertebral level in which the implant is to be inserted.

[0035] Examples of the morphology and structure of these balloons (1) for various treatments are described below. Starting with vertebral deformations, such as degenerative scoliosis, for example, the one observed in the patient in FIG. 5. In this case, an implant like the one represented in FIG. 4 is inserted in an axial section of a lumbar disc, where it is shown how the morphology of the implant has the largest contact surface in the anterior part (15) and in the concavity of scoliosis, which is precisely where the greatest corrective forces for correcting the deformity should be applied and where the implant will suffer greater mechanical strain.

[0036] The medical literature in this pathology contains no descriptions of percutaneous surgical treatment with the methodology presented herein. There is also no knowledge of patents related to the percutaneous treatment of this pathology, nor to the methodology and type of implant herein proposed, performing it openly.

[0037] The insertion of the trocar into the disc (5) is preferably performed from the side of convexity, where it is technically very easy to reach the disc and properly place the implant in the anterior situation and in the concavity of scoliosis. Taking into account that this pathology frequently affects elderly patients and that the degenerative disc changes are very severe, with an almost total absence of tissue in the intervertebral disc space and frequent sclerosis of the endplates, the implant is adapted to these characteristics. In the design of this implant, the importance of applying corrective forces for correcting scoliosis at the appropriate level, which is the concavity of scoliosis and the anterior part of the vertebral body, has also been taken into account to correct kyphosis. The implant is made in such a way that these two levels will be where the contact surfaces of the implant with the vertebral bodies will be more extensive.

[0038] The implant, i.e., the shaped balloon, maintains the indurated cephalic and caudal surfaces to maintain contact with the generally sclerotic vertebral endplates. The implant is filled with cement having elastic characteristics as described previously, taking into account the frequent associated sclerosis of the endplates.

[0039] For the treatment of kyphosis, anterior vertebral imbalances and spondylolisthesis, the same implant described for the treatment of degenerative scoliosis is used, but positioned differently. The area where the maximum corrective forces will be applied and where the greatest mechanical stresses will be maintained after correction is in the anterior part of the vertebral body and this anterior and central area is where the implant must be placed (see FIG. 7). For this, the percutaneous entry point in the disc must be made subsequently by using a trocar that allows 60-90 angulation of the distal end with external control, to allow the implant to be positioned in the anterior and central part of the vertebral body and said position is where the implant must be inflated.

[0040] In the treatment of disc degeneration, whether in the cervical, thoracic or lumbar spinal column, and lumbar spinal stenosis, the implant shown in FIG. 8 is used. In this case, the implant is made up of a balloon (1) made of a flexible, biocompatible material that is capable of being inflated, and which can be inserted into the intervertebral disc by a trocar. When this balloon (1) is inflated, it increases in size inside the disc, taking on a substantially cylindrical shape. This central cylinder is in contact with and surrounded by a second balloon (16), which can also be inflated around the first cylinder (1) and independently of it.

[0041] When this implant is used, in cases of disc degeneration or lumbar spinal stenosis, with the aim of increasing the stability of the implant and providing greater disc mobility, causing a smoother transition to the annulus fibrosus, the central cylinder (16) is filled with an elastic cement (21) having elasticity less than or equal to the cement (2) that fills the peripheral cylinder (1).

[0042] The balloon (1) has radiopaque circular markers (17) on both bases that allow the exact location of the implants relative to the vertebral endplates to be observed, said endplates being where the balloon must be located to facilitate its load-transmitting function. These markers can be viewed when placing the balloon in the intervertebral disc space under radioscopic control, navigation, or when placed robotically.

[0043] Fractures of the vertebral body are associated with sinking of the endplates that causes an alteration of the normal functional mechanics of the disc, in other words, the transmission of weight load when the disc loses contact with the adjacent bone elements, since for the disc to suitably transmit the load, it is necessary to have precise contact with both endplates of the adjacent vertebrae, and in fractures with vertebral bone sinking, the contact either does not exist or is not uniform. Consequently, the normal sagittal curves of the spinal column are also altered, giving rise to kyphotic changes with negative biomechanical consequences for the patient.

[0044] Even in minor fractures, especially at critical levels such as the thoraco-lumbar transition or lower lumbar levels where mechanical and mobility stresses are greater, disc functionality is lost and compression of the neighboring neurological structures and very high mechanical stresses are produced on the ligamentous elements of the middle and posterior column that lead to their progressive degeneration. Consequently, it is of great importance to correct the anterior disc instability of the fractured level, recover disc functionality and maintain vertebral mobility of the injured segment percutaneously, as is done in this proposal.

[0045] The disc injury or injuries produced with the vertebral fracture will be treated percutaneously, correcting post-fracture kyphosis by replacing the disc with an elastic disc prosthesis that allows correcting and maintaining the correction of the vertebral deformity while maintaining the mobility of the fractured level.

[0046] FIG. 9 shows the repair of a severe fracture of the L1 (Kummel) vertebra, without affecting the T12 endplate, treated percutaneously and using implants such as those of the present invention. For this, a kyphoplasty of the L1 body is first performed with a balloon (1) to lift the height of the L1 vertebral body as much as possible. Next, the kyphotic deformity at this level is corrected and stabilized by inserting into the T12-L1 disc a preformed balloon (6) with a flat surface adapted to the T12 distal endplate, which is shaped as rigid or semi-rigid when filled with a bone cement. Inflating this balloon lifts the anterior spinal column and corrects the kyphotic vertebral deformity. Filling the balloon with elastic cement maintains the correction and allows vertebral mobility.

[0047] As previously mentioned, in this type of fracture two different balloons are used: a first balloon (6) that is placed inside the fractured vertebral body and is completely elastic, and a second balloon (1) that is inserted into the fractured space and also into the space where the disc was located before the fracture. This preformed balloon (1) has two compartments: a disc-shaped compartment (18), which adapts to the vertebral endplate that is not sunken, and another lower compartment that adapts to the sunken vertebral plate. The compartment (18) is cylindrical, since it represents the disc morphology and will be filled with a bone cement having the consistency and elasticity of the bone to be replaced, while the other compartment will be filled with an elastic cement (2) that is comparable to normal disc elasticity.

[0048] This balloon (1) is inflated after inserting the first balloon (6) inside the vertebral body to correct the height of that vertebra and fill it with the elastic material. Inflating this balloon (1) allows focal kyphosis at this level to be corrected under radioscopic control.

[0049] A fracture of the two vertebral plates adjacent to the disc (FIG. 10) requires three balloons to be used to repair it:

[0050] Respective balloons (6), which are inserted into each of the two fractured vertebrae to correct, after inflation, the height of the vertebral bodies following the previously indicated methodology.

[0051] The third balloon (1) is inserted at the height of the injured disc. In the example of FIG. 10, the third balloon (1) is divided into three compartments according to substantially horizontal planes, capable of being inflated independently. The intermediate compartment forms the intervertebral disc and is first filled with an elastic cement (21) having a consistency similar to that of the normal disc, and finally the two compartments, upper and lower, are filled with a cement (2) having elasticity greater than or equal to the cement (21) so that the balloon (1) adapts at the top and internally to the two irregular fractured surfaces of the adjacent vertebrae.

[0052] Once the nature of the invention has been described, as well as a preferred exemplary embodiment, it is clear that the invention is capable of industrial application, in the indicated sector.

[0053] It is also stated for appropriate purposes that the materials, shape, size and arrangement of the elements described may be modified, as long as this does not imply an alteration of the essential features of the invention that are claimed below: