# Patent

## Title
Device for straightening and stabilizing the vertebral column

## Abstract

A device for straightening and stabilizing the vertebral column, particularly for stabilizing broken vertebrae, includes a supporting implant which is plastically expandable by internal pressure. The supporting implant can be placed into the interior of a vertebral body which has been fractured under compression or between adjacent vertebral bodies. A pressure balloon to which pressure fluid can be admitted may be arranged in the interior of the supporting implant for producing the internal pressure.

## Background
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No. 12/268,215, which was filed on Nov. 10, 2008 which is a divisional of U.S. patent application Ser. No. 10/286,458, which was filed on Nov. 1, 2002, which claims priority to German Patent Application No. DE 101 54 163.5 filed Nov. 3, 2001, the entire contents of each of these applications is incorporated herein by reference.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a device for straightening and stabilizing the vertebral column, particularly for stabilizing broken vertebrae.
2. Description of the Related Art
Devices for straightening and stabilizing broken vertebrae are known to be used. These devices include a catheter which can be inserted into the interior of the vertebra through a duct drilled into the pedicle of the broken vertebra. A pressure line pushed through the catheter into the interior of the vertebra has at the end thereof an expandable pressure balloon which makes it possible to expand once again and return into its original shape a vertebra which has been compressed and possibly broken. The balloon which has subsequently been decompressed and pulled out together with the pressure line leaves a hollow space into which a bone filler material can be introduced through the catheter.
SUMMARY OF THE INVENTION
It is the primary object of the present invention to provide a novel device for stabilizing the vertebral column, particularly for straightening and stabilizing broken vertebrae, which makes it possible to achieve a higher degree of stabilization more quickly than by using the known devices, wherein the required operation is simpler.
In accordance with the present invention, the device for straightening and stabilizing the vertebral column is characterized by a supporting implant which is plastically expandable by internal pressure.
Such a supporting implant, which is preferably provided for being arranged in the interior of a vertebral body fractured under compression or also, for example, after an intervertebral disc resection for arrangement between adjacent vertebral bodies, can be easily moved to the implantation location because of its small dimensions. After the expansion has been effected, a preliminary stabilization is ensured immediately because the supporting implant maintains its final shape obtained during the plastic expansion. A filler material which is initially present in liquid form can be introduced under slight pressure into the created hollow space and can harden in the hollow space. Because of the action of the supporting implant, it is not necessary to wait until the filler material has hardened completely.
While mechanical tools for producing the internal pressure are conceivable, a preferred embodiment of the invention provides for a device which produces the internal pressure by means of a pressure fluid.
The pressure fluid can be introduced directly into the supporting implant, which requires that the supporting implant and the supply connections are pressure tight. However, in accordance with a preferred embodiment, a pressure balloon is provided which is arranged in the interior of the supporting implant and into which the pressure fluid can be introduced.
The expandable supporting implant may include a weakened wall, or a wall which is perforated in the manner of expanded metal and/or folded in the manner of a bellows.
This type of supporting implant can be expanded with relatively low internal pressure, wherein the stability of the expanded implant is reduced by the weakened or folded portions, however, the implant can still carry out a sufficient supporting function.
The wall of the expandable supporting implant may have weak portions and/or folds arranged in such a way that the supporting implant expands into a desired shape. For example, if such a supporting implant is arranged between adjacent vertebrae, the desired shape is approximately that of a parallelepiped.
In accordance with a preferred embodiment of the invention, the expandable supporting implant has an oblong shape so that it is suitable for being arranged at the implantation location by means of a catheter or a guide sleeve. In particular, the expandable supporting implant, and possibly the pressure balloon, may be placed in the manner of a stocking on a pressure line which can be introduced through the guide sleeve, wherein the pressure balloon is arranged between the supporting implant and the pressure line and, in the non-expanded state, foams a hose-type sleeve which surrounds the pressure line and which is connected at its ends in a pressure-tight manner by being placed around the circumference of the pressure line.
The pressure fluid is preferably not compressible, and a device for measuring the supplied amount of pressure fluid is provided. This makes it possible to control the degree of expansion through the supplied quantity.
In accordance with another advantageous embodiment of the invention, a monitoring device is provided which monitors changes over time of the fluid pressure and the supplied fluid quantity so that the pressure application can be interrupted when predetermined relative values of these changes are exceeded. Such a monitoring device prevents fluid which is under high pressure from being released into the body when the supporting implant is destroyed, for example, as a result of a material defect.
The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of the disclosure. For a better understanding of the invention, its operating advantages, specific objects attained by its use, reference should be had to the drawing and descriptive matter in which there are illustrated and described preferred embodiments of the invention.



BRIEF DESCRIPTION OF THE DRAWING
In the drawing:
FIG. 1 is a schematic sectional view of a device according to the invention with a supporting implant placed on a pressure line;
FIG. 2 is an illustration of a detail of the supporting implant of FIG. 1;
FIG. 3 is an illustration, on a smaller scale, showing the device of FIG. 1 inserted into a broken and compressed vertebral body;
FIG. 4 shows the vertebral body of FIG. 3 which has been expanded by means of the device of FIG. 1; and
FIG. 5 is an illustration of another embodiment of the supporting implant which can be used in a device of the invention.



DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 of the drawing shows a guide sleeve 1 and a pressure line 2 extending through the guide sleeve 1, wherein the pressure line 2 is provided with an opening 3 for releasing a pressure fluid.
An elastic hose-type sheath 4 is placed in the manner of a stocking and flush at the ends thereof on the circular cylindrical pressure line 2. The sheath 4 is glued in a pressure-tight manner at its ends to the circumference of the pressure line 2 at 5 and 6. Instead of providing a glued connection, it would also be possible to press the elastic sheath 4 at the ends thereof by means of rings against the pressure line.
A hollow-cylindrical supporting implant 7 is placed around the elastic sheath 4. As can be seen in FIG. 2, the cylindrical wall 8 of the implant 7 is a mesh-like material with openings 9, wherein wires of the mesh extend at an acute angle relative to each other. The wall 8 can be tangentially expanded in the manner of expanded metal in the direction of double arrow 21, so that the supporting implant 7 is radially expanded.
At its end opposite the sheath 4 or the supporting implant 7, the pressure line 2 is in connection with a schematically illustrated device 10 for supplying an incompressible pressure fluid 11, wherein this device 10 includes a pressure cylinder 12 and a piston 13. The piston 13 may be movable manually, preferably by means of a screw-type pressure gauge, or by means of a motor drive.
Reference numeral 14 denotes a schematically illustrated control and monitoring device which includes a pressure indicator 16 and a display 17 for the supplied quantity of pressure fluid.
The manner of operation of the device is shown in FIGS. 1 and 2 and shall now be explained in connection with FIGS. 3 and 4.
For stabilizing a broken vertebra, initially a duct 18 is drilled through the pedicle 20, wherein a catheter and a drilling tool extending through the catheter can be used for this purpose. As shown in FIGS. 3 and 4, the guide sleeve 1 is now placed in the duct 18 and the pressure fluid 2 with the supporting implant 7 can be forwardly pushed into the interior of the compressed vertebra which has compression folds at 19.
The incompressible pressure fluid 11 is pressed by means of the device 10 into the pressure line 2, the pressure fluid 11 emerges from the opening 3 and the elastic sheath 4 is expanded into a balloon. The expanding sheath or balloon 4 expands the supporting implant 7, as illustrated in FIG. 4, wherein the wall 8 of the supporting implant 7 is plastically deformed in the direction of arrow 21 shown in FIG. 2 and the acute angles between the mesh wires at 17 are widened.
The quantity of supplied pressure fluid during the expansion can be read at the display 17 of the control and monitoring device 14 and, thus, the extent of the achieved expansion can be determined. The expansion or supply of pressure fluid is stopped when a predetermined value of the supplied pressure fluid quantity has been reached.
The control and monitoring device 14 further ensures that the application of pressure is stopped immediately if the balloon 4 ruptures during the expansion, for example, due to a material defect, and pressure fluid is released from the vertebra; this is the case when the supplied pressure fluid quantity increases significantly over time, while the pressure stays constant or increases only slightly.
After the required expansion has been achieved, the pressure fluid is withdrawn through the opening 3 which is located near the lowest point of the balloon 4. The pressure line 2 with the empty pressure balloon or the empty sheath 4 can now be pulled back through the guide sleeve 1.
The plastically deformed supporting implant 7 maintains its shape and supports the vertebra in such a way that it maintains the shape shown in FIG. 4 and the damage shown at 19 can heal. A filler material is introduced into the interior of the supporting implant.
FIG. 2 is a cross-sectional view of another embodiment of a supporting implant 7a according to the invention. The supporting implant 7a has in its wall 8a folds 22, wherein the folds on opposite sides have different lengths, so that the expanded implant has a rectangular shape in cross-section.
In the embodiment described above, a salt solution containing an x-ray contrast agent is used as the pressure fluid.
Of course, two of the above-described supporting implants can be and are usually inserted into a broken vertebra, wherein ducts are drilled in both pedicles for inserting a catheter.
While specific embodiments of the invention have been shown and described in detail to illustrate the inventive principles, it will be understood that the invention may be embodied otherwise without departing from such principles.

## Claims

1. A device for stabilizing a broken vertebra, the device comprising a hollow-cylindrical, plastically deformable supporting implant that is insertable into an interior of the vertebra, wherein the implant comprises a wire mesh comprising openings, wherein the wires of the mesh extend at an acute angle relative to each other to form adjacent-acutely angled segments that bound a common opening and that open in the same direction, thereby forming said openings between the wires, so as to be plastically radially deformable to deform from an initial non-expanded state to an expanded state to form a hollow space in the interior of the vertebra, wherein in the expanded state the acute angles of the mesh wires are widened, wherein in the expanded state the plastically deformed supporting implant maintains the shape of the implant and stabilizes the vertebra to allow the broken vertebra to heal, and wherein the device is capable of allowing passage of a material from the hollow space in the interior of the vertebra through the openings to the vertebra, said openings being present before the supporting implant is implanted.

2. The device of claim 1, the device further comprising a pressure balloon configured for applying an internal pressure to the supporting implant.

3. The device of claim 2, the device further comprising a pressure line, wherein the pressure balloon is mounted to the pressure line, wherein the pressure line provides a pressurized fluid to the pressure balloon for inflation of the pressure balloon, and wherein the supporting implant surrounds a distal portion of the pressure line.

4. The device of claim 3, wherein the pressure balloon is releasably fitted to a distal portion of the pressure line, and wherein the pressure balloon is releasable from the pressure line upon expansion of the pressure balloon.

5. The device of claim 2, further comprising: a fluid pressurizing device for providing a pressurized fluid to the pressure balloon for inflation of the pressure balloon; and a measurement device for measuring the quantity of the pressurized fluid supplied to the pressure balloon.

6. The device of claim 2, further comprising: a fluid pressurizing device for providing a pressurized fluid to the pressure balloon for inflation of the pressure balloon; and a control and monitoring device for monitoring changes over time of the pressure of the pressurized fluid and of the quantity of the pressurized fluid supplied to the pressure balloon, wherein the control and monitoring device causes the fluid pressurizing device to cease provision of the pressurized fluid to the pressure balloon when predetermined relative values of the changes are exceeded.

7. A system for stabilizing a broken vertebra, the system comprising:
a device, the device comprising a hollow-cylindrical, plastically deformable supporting implant that is insertable into an interior of the vertebra, wherein the implant comprises a wire mesh comprising openings, wherein the wires of the mesh extend at an acute angle relative to each other to form adjacent acutely-angled segments that bound a common opening and that open in the same direction, thereby forming said openings between the wires, so as to be plastically radially deformable to deform from an initial non-expanded state to an expanded state to form a hollow space in the interior of the vertebra, wherein in the expanded state the acute angles of the mesh wires are widened, wherein in the expanded state the plastically deformed supporting implant maintains the shape of the implant and stabilizes the vertebra to allow the broken vertebra to heal, and wherein the device is capable of allowing passage of a material from the hollow space in the interior of the vertebra through the openings to the vertebra, said openings being present before the supporting implant is implanted; and
a pressure balloon configured for applying an internal pressure to the supporting implant.

8. The system of claim 7, the system further comprising a pressure line, wherein the pressure balloon is mounted to the pressure line, wherein the pressure line provides a pressurized fluid to the pressure balloon for inflation of the pressure balloon, and wherein the supporting implant surrounds a distal portion of the pressure line.

9. The system of claim 8, wherein the pressure balloon is releasably fitted to a distal portion of the pressure line, and wherein the pressure balloon is releasable from the pressure line upon expansion of the pressure balloon.

10. The system of claim 7, further comprising: a fluid pressurizing device for providing a pressurized fluid to the pressure balloon for inflation of the pressure balloon; and a measurement device for measuring the quantity of the pressurized fluid supplied to the pressure balloon.

11. The system of claim 7, further comprising: a fluid pressurizing device for providing a pressurized fluid to the pressure balloon for inflation of the pressure balloon; and a control and monitoring device for monitoring changes over time of the pressure of the pressurized fluid and of the quantity of the pressurized fluid supplied to the pressure balloon, wherein the control and monitoring device causes the fluid pressurizing device to cease provision of the pressurized fluid to the pressure balloon when predetermined relative values of the changes are exceeded.

12. A system for stabilizing a broken vertebra, the system comprising:
a device, the device comprising a hollow-cylindrical, plastically deformable supporting implant that is insertable into an interior of the vertebra, wherein the implant comprises a wire mesh comprising openings, wherein the wires of the mesh extend at an acute angle relative to each other to form adjacent acutely-angled segments that bound a common opening and that open in the same direction, thereby forming said openings between the wires, so as to be plastically radially deformable to deform from an initial non-expanded state to an expanded state to form a hollow space in the interior of the vertebra, wherein in the expanded state the acute angles of the mesh wires are widened, wherein in the expanded state the plastically deformed supporting implant maintains the shape of the implant and stabilizes the vertebra to allow the broken vertebra to heal, and wherein the device is capable of allowing passage of a material from the hollow space in the interior of the vertebra through the openings to the vertebra, said openings being present before the supporting implant is implanted;
a pressure balloon configured for applying an internal pressure to the supporting implant; and
a pressure line, wherein the pressure balloon is mounted to the pressure line, wherein the pressure line provides a pressurized fluid to the pressure balloon for inflation of the pressure balloon, and wherein the supporting implant surrounds a distal portion of the pressure line.

13. The system of claim 12, wherein the pressure balloon is releasably fitted to a distal portion of the pressure line, and wherein the pressure balloon is releasable from the pressure line upon expansion of the pressure balloon.

14. The system of claim 12, further comprising: a fluid pressurizing device for providing a pressurized fluid to the pressure balloon for inflation of the pressure balloon; and a measurement device for measuring the quantity of the pressurized fluid supplied to the pressure balloon.

15. The system of claim 12, further comprising: a fluid pressurizing device for providing a pressurized fluid to the pressure balloon for inflation of the pressure balloon; and a control and monitoring device for monitoring changes over time of the pressure of the pressurized fluid and of the quantity of the pressurized fluid supplied to the pressure balloon, wherein the control and monitoring device causes the fluid pressurizing device to cease provision of the pressurized fluid to the pressure balloon when predetermined relative values of the changes are exceeded.