Patent Application
20230165608
The invention relates to a height restoring device for restoring the height of and stabilizing the spinal column, in particular for stabilizing broken vertebral bodies or contused intervertebral discs, which device can be arranged in an insertion position in a compression-fractured vertebral body or between adjacent vertebral bodies and once there, can be transferred from the insertion position into an expansion position by means of an expansion apparatus.
Height restoring devices are known from the prior art, which are used to restore the height of and stabilize broken vertebral bodies. Devices of this kind may comprise a catheter that can be inserted into the vertebral cavity through a passage drilled in the pedicle of the broken vertebra. It is also known to guide a pressure balloon, which can be expanded via a pressure line, through the catheter into the cavity of the vertebra, as a result of which a vertebral body that was contused or possibly broken by compression can be expanded again and returned to the original shape thereof. It is also known to remove the pressure balloon after the height of the vertebral body was restored and to fill the cavity created by the pressure balloon with hardening bone filling material.
It is known from EP 1 308 134 B1 to provide a support body that is made of expanded metal and has an expandable wall in order to prevent the cavity created by the body from being compressed again after the pressure balloon has been removed. However, it has been shown that the expanded metal does not always reliably retain the expansion position thereof after the pressure balloon has been removed, since the forces acting on the support body may be comparatively high.
US Patent US 2016/0302942 A1 describes a height restoring device having features of the preamble of claim 1. The support body shown there has a central portion and an upper and lower bone contact structure, with the central portion being shifted axially in order to shift the support body into the expansion position, as a result of which the bone contact structures are shifted upward and downward. The length extension of the support body remains unchanged during the height restoring process.
Other similar devices are known from U.S. Pat. No. 6,127,597, US 2012/0071977, US 2009/0204216 A1, and WO-A-0176514.
EP 2405835B1 discloses an implant that has a support body having position surfaces that are held in an expansion position by means of pairs of supports. Furthermore, a proximal and a distal end portion are provided, the pairs of supports being assigned to the end portions and the end portions being moved toward one another when shifted into the expansion position. For this purpose, the individual supports of the pairs of supports each have a first engagement element and a second engagement element, the engagement elements of the supports of the pairs of supports engaging with one another.
The object of the present invention is to provide a height restoring device and an insertion apparatus having a height restoring device with which a safe expansion of the support body is ensured. In particular, the aim is to ensure that the cavity created by the height restoring device in the expansion position is retained during and after the expansion and in particular before any filling material is introduced into the cavity, and that the height restoring device is as slim as possible in the insertion position and as short as possible in the expansion position. In addition, it is desirable to expand the height restoring device from the insertion position into the expansion position by means of a pressure balloon that can be arranged inside the height restoring device.
This object is achieved by a height restoring device having the features of claim 1.
Consequently, it is provided in particular that, when the support body is shifted into the expansion position, the end portions move toward one another along the longitudinal axis and the support portions move radially outward relative to the carrier portions, so that their latching portions act against the counter-latching portions of the carrier portions for latching.
Thus, when expanding the support body, both the support portions and the carrier portions are shifted radially outward relative to one another, with the relative movement resulting in a secure latching of the latching portions into the counter-latching portions. Furthermore, a cavity is created in the central region of the support body, i.e., in the region of the central longitudinal axis. On the one hand, a pressure balloon can unfold in the cavity to expand the support body and, on the other hand, the cavity can be filled with bone cement after the pressure balloon has been removed.
The carrier portions and/or the support portions are preferably designed at least in portions as resiliently yielding webs or bands or in a web-like or band-like manner, in particular at least in the portions or regions in which they act against one another.
Preferably, four, five, six, or more carrier portions and a corresponding number of support portions are provided, with the individual carrier portions and support portions each being symmetrical to the longitudinal axis. This has the advantage that it is not necessary to pay attention to top, bottom, right, or left when inserting the height restoring device.
Due to the latching fixation, it can be achieved that the support portions act directly against the inner sides of the carrier portions and support the carrier portions in a stabilizing manner not only in the expansion position but also during the expansion of the support body, so that they can stably retain their expansion position after the expansion has ended or after the expansion apparatus has been switched off and in particular, when using pressure balloons, after removing the pressure balloons.
The latching fixation forms in this case in particular a kind of free-running locking mechanism which causes the carrier portions to move into the expansion position, i.e., in the free-running direction, but blocks the return movement of the carrier portions into the insertion position due to the latching.
It is provided that the support portions have latching portions and that the carrier portions have counter-latching portions, so that the latching portions act against the counter-latching portions for latching fixation of the carrier portions. Overall, an at least largely form-fitting interaction of latching portions and counter-latching portions can be achieved in this way, the arrangement preferably being such that, during further expansion, the support portions or their latching portions interact with the counter-latching portions in such a way that reliable support is achieved by the latching, and a movement of the carrier portions back in the direction of the insertion position is blocked during the entire widening process of the support body.
The individual latching portions and/or counter-latching portions can be designed as several latching elements lying one behind the other and/or next to one another. For this, in particular latching webs, openings, recesses, impressions, corrugations, projections, pawls, teeth, and/or saw teeth come into consideration as latching elements. In this way, in particular, a free-running locking mechanism can be implemented in an advantageous manner.
Even if latching portions and counter-latching portions are discussed here, this should also mean friction portions and counter-friction portions. The friction portions and/or counter-friction portions can in particular have a correspondingly rough surface or a friction lining with a suitable grain size or coating.
Furthermore, it is advantageous that the carrier portions are arranged radially on the outside and the support portions are arranged radially on the inside. The carrier portions can consequently cover the support portions, in particular in the insertion position. It is advantageous if the latching portions are provided on the radially outer side of the support portions and/or if the counter-latching portions are provided on the radially inner side of the carrier portions.
The support portions and also the carrier portions are preferably designed to be resiliently yielding such that they move radially outward at least in portions when shifted into the expansion position, and that the mutually facing sides of the support portions and carrier portions can interact with one another for latching fixation.
Furthermore, it has proven to be advantageous if the support portions are provided on the respective end portions or are formed onto them or are connected to them. As a result, they can assume a defined position, so that, in the expansion position, they can reliably dissipate forces acting on the carrier portions via the end portions into the support body.
It has also turned out to be advantageous if a structure is provided between the carrier portions and the end portions, which structure shortens the distance between the carrier portions and the end portions when shifted into the expansion position. The shortening can be brought about or increased by the relative movement between the carrier portions and the support portions. The relative movement results in the latching of the respective latching portions into the respective counter-latching portions. The structure can be formed from an expanded or support mesh, for example.
It has been found to be preferable if the structure is formed by connecting webs extending in the axial direction between the individual carrier portions and the corresponding end portion, in particular in the insertion position. Two connecting webs each which, in the insertion position, extend in the axial direction may be provided between each carrier portion, each designed in particular also in a web-like manner, and the corresponding end portion. In the insertion position, the connecting webs then lie next to one another in a circular path about a longitudinal axis. The connecting webs serve in particular to guide the carrier portions when shifted into the expansion position. Due to the comparatively filigree design of the connecting webs, the connecting webs are not used in particular to support the carrier portions; the support portions which act against the inner side of the carrier portions are provided for this purpose.
In order to achieve a suitable shortening of the distance between the carrier portions and the end portions when shifted into the expansion position, it is conceivable that the connecting webs of respectively adjacent carrier portions are connected to one another, in particular at connection points, or that adjacent carrier portions at least partially provide common connecting webs. The connecting webs can be spread apart when shifted into the expansion position, as a result of which the distance between the carrier portions and the end portions is shortened overall and thus a relative movement between the carrier portions and the support portions is caused. The relative movement ultimately results in the latching of the respective latching portions into the respective counter-latching portions.
It is also conceivable that the support portions each have at least two partial support portions having latching portions, and that an intermediate portion is provided between the partial support portions, which intermediate portion is not expanded radially outward or is expanded less than the partial support portions when it is transferred into the expansion position. An arrangement of this kind is comparatively space-saving, in particular in the insertion position, and can nevertheless result in reliable support of the carrier portions. An intermediate portion is advantageously provided centrally between the two end portions. However, it is also conceivable that two or more intermediate portions are provided. The provision of such an intermediate portion contributes to a relative movement taking place between the carrier portions and the support portions during expansion.
The at least one intermediate portion may be formed by a sleeve or a ring, both of which do not noticeably deform when shifted into the expansion position. The design with an intermediate portion as a sleeve or ring also has the advantage that, in the expansion position, forces acting on the carrier portions perpendicular to the central axis can be advantageously dissipated via the support portions that then enclose comparatively small angles with a plane running perpendicular to the central axis. It is also conceivable that the intermediate portion is formed by expanded or support mesh. The intermediate portion is preferably formed from connecting webs, at least two connecting webs which, in the insertion position, extend in the axial direction being provided on the respective partial support portions, and the connecting webs of respectively adjacent partial support portions being connected to one another in particular via connection points, or adjacent partial support portions at least partially providing common connecting webs. In particular in the insertion position, the connecting webs then lie next to one another in a circular path about a longitudinal axis. The connecting webs can be spread apart when shifted into the expansion position, as a result of which the distance between the partial support portions is shortened overall and thus an additional relative movement between the carrier portions and the support portions is caused. The relative movement ultimately results in the latching of the respective latching portions into the respective counter-latching portions.
A further embodiment provides that the carrier portions are connected to the support portions at the proximal end portion and at the distal end portion. Overall, this results in a simple structure.
It is also advantageous if the support body has a two-layer structure concentric about a longitudinal axis in the insertion position, the inner part being formed by the support portions and the end portions, and the outer part being formed by the carrier portions and in particular also by the structure. In addition, it is advantageous if, in the insertion position, the support portions are arranged running substantially parallel to the carrier portions in the axial direction, and it is advantageous that the carrier portions at least largely enclose the support portions. A structure of this kind can be built comparatively slim and is therefore suitable due to the fact that the height restoring device, in the insertion position, can be shifted in a space-saving manner to the intended expansion site in the body by means of an insertion catheter.
With the expansion apparatus, fillable pressure balloons can be placed in particular between the end portions, the intermediate portion, and the corresponding end portion and/or between the adjacent intermediate portions such that the corresponding pressure balloon dilates for transfer to the expansion position and that, when the corresponding pressure balloon dilates, the carrier portions are moved in the radial direction, and at the same time the support portions act in a latching manner against the carrier portions to fix the carrier portions. The provision of a plurality of pressure balloons, which may be arranged one behind the other in particular along the axial direction, has the advantage that these can preferably be dilated independently of one another, so that a functionally reliable and reproducible expansion and thus widening of the space in the corresponding vertebral body or between the vertebral bodies can be achieved.
Advantageously, the pressure balloons can be removed after the expansion position has been reached, and the cavity of the expanded support body can be filled with hardening bone filling material. Due to the latching fixation of the support portions, the pressure balloons can consequently be removed without the support body and the cavity created by the support body being pressed together or compressed again. Forces can be safely absorbed via the expanded support body, and the cavity created by the support body is retained, so that in particular hardening filling material can be introduced into the cavity. The height restoring device is in this case preferably designed as an implant and remains in the body.
According to the invention, it is also conceivable that the proximal and/or the distal end portion has/have a through hole having an inner thread for screwing in a fixing screw after the expansion position has been reached. The expansion position can consequently be secured with the fixing screw. The securing can take place until the cavity created by the support body is filled with filling material. However, it is also conceivable for the expansion position to be permanently secured with the fixing screw, in which case the cavity does not have to be filled with filling material.
Furthermore, it is advantageous if a net or honeycomb structure is provided between the end portions and the corresponding intermediate portion and/or between the adjacent intermediate portions. In particular, a fillable pressure balloon can then be placed within the corresponding net or honeycomb structure. In particular, the net or honeycomb structure results in a homogeneous and stable overall surface, as a result of which the height restoring device can be designed more stable overall. In addition, the implant can have a positive effect on the surroundings and not partially result in traumatization.
The height restoring device can be made of titanium, stainless steel, CoCr, or similar implant materials. It is also conceivable that different materials are used. A combination of different materials with different manufacturing processes is also possible. In particular, it is conceivable for the device, or parts thereof, to be manufactured by means of additive manufacturing methods, as a result of which the carrier portions and the support portions in particular can be partially reinforced.
The object mentioned at the outset is also achieved by an insertion apparatus having an insertion cannula and a height restoring device according to the invention provided in or at the free end of the insertion cannula, which height restoring device can be inserted into a compression-fractured vertebral body or between adjacent vertebral bodies, the insertion cannula actuating the expansion apparatus, and, if necessary, the support body being filled with filling material or the fixing screw being screwed in. The expansion apparatus and preferably one or more fillable pressure balloons can consequently be actuated via the insertion cannula, as a result of which the height restoring device or the support body can be shifted from the insertion position into the expansion position. After the expansion position has been reached, the insertion apparatus or the pressure balloons can be removed from the height restoring device via the insertion cannula, and the cavity created by the support body can be filled with filling material, or the fixing screw can be introduced. The insertion apparatus is designed in such a way that the diameter of the insertion cannula corresponds at least largely to the diameter of the height restoring device in the insertion position. Such an insertion apparatus can, for example, be brought to the expansion site by means of an insertion catheter, in which site the height of the vertebral body or bodies in question is to be restored.
It is also advantageous if a shiftable inner cannula is provided on the inner wall of the insertion cannula, which inner cannula is coupled to the height restoring device in such a way that the height restoring device is detached from the insertion cannula by moving the inner cannula in the distal direction. The height restoring device can thus be decoupled from the outer cannula via the inner cannula. The decoupling is particularly advantageous before the pressure balloons are dilated, because the height restoring device expands in the radial direction and at the same time the length thereof in the axial direction is reduced when the pressure balloons are dilated. Due to the decoupling of the height restoring device and the outer cannula, the height restoring device can expand freely.
Advantageously, the insertion apparatus comprises a stylet having a cutting tip, which stylet can be passed through the insertion cannula and through the height restoring device, and the cutting tip of which forms the distal end of the insertion apparatus in an insertion configuration, so that the height restoring device can be inserted directly into a vertebral body for restoring the height of the corresponding vertebral body, or between adjacent vertebral bodies, i.e., for restoring the height of an existing intervertebral disc between the respective vertebral bodies. This embodiment has the advantage that the insertion apparatus, and in particular the height restoring device, does not have to be brought to the intended location by an insertion catheter, but rather can be moved directly through the corresponding tissue to the intended expansion site without having to be moved via such an insertion catheter. An insertion catheter is consequently not necessary.
To actuate the height restoring device, it is advantageous if an actuating apparatus is provided at the proximal end of the insertion apparatus, with which actuating apparatus the inner cannula can be shifted in the distal direction to detach the height restoring device, and/or with which the inner cannula can be inserted into the insertion cannula or removed from it, and/or with which the stylet can be inserted into or removed from the inner cannula, and/or with which the height restoring device can be brought to the corresponding expansion site in the body.
The object mentioned at the outset is also achieved by a method for restoring the height of and stabilizing the spinal column, in particular for stabilizing broken vertebral bodies or contused intervertebral discs using an insertion catheter according to the invention, the height restoring device being introduced in the insertion position into a vertebral body or between vertebral bodies into the expansion site, and there the height restoring device being transferred from the insertion position into the expansion position. Such a method can be used to restore the height of and stabilize the spinal column in a comparatively simple and yet functionally reliable manner.
In particular, the method can provide that, before the expansion of the height restoring device, an access to the expansion site in the body is created, through which access the height restoring device extends to the expansion site. Access can be created in this case as follows:
In this case, the cannula has an inner diameter that is dimensioned so that the height restoring device can be inserted through the access formed by the cannula into the expansion site.
Creating the access first and then inserting the height restoring device through the access is advantageous in particular when the insertion apparatus does not comprise a stylet having a cutting tip, with which stylet the height restoring device can be introduced directly into a vertebral body or between adjacent vertebral bodies.
However, if the insertion apparatus has a stylet having a cutting tip, the height restoring device can also be inserted directly into a vertebral body or between adjacent vertebral bodies into the expansion site.
The method can further provide for at least one pressure balloon to be inserted through the cannula into the expansion site and to be dilated to widen the expansion site and to create a cavity before the height restoring device is inserted into the access.
In particular, the method further provides that, after the expansion site has been widened and the at least one pressure balloon has been removed, the height restoring device is inserted through the access into the expansion site.
In particular, the method also provides that after the insertion of the height restoring device into the expansion site pressure balloons placed in the height restoring device are dilated for transferring the height restoring device into the expansion position, and that the pressure balloons are removed after the height restoring device has reached the expansion position.
It may also be provided for bone filling material to be introduced into the support body after the pressure balloons have been removed.
However, it is also conceivable that the height restoring device is pulled back in the proximal direction before the pressure balloons are dilated in the height restoring device, and the pressure balloons are introduced into the cavity created in the distal direction behind the height restoring device and dilated to create a cavity, and then either the cavity is filled with filling material immediately after the pressure balloons have been removed or the height restoring device is introduced into the cavity and expanded there. If it turns out that the cavity as such is stable enough, the procedure can be in such a way that the cavity is filled directly with bone filling material or bone cement without the height restoring device being introduced into the cavity and expanded there. A procedure of this kind has the advantage that it is possible to align and restore the height of the spinal column without the height restoring device remaining in the body. However, should the cavity prove not to be sufficiently stable, the height restoring device can be inserted into the cavity by being pushed distally and expanded there before bone filling material is introduced through the insertion cannula into the vertebra or between the vertebral bodies.
In this case, it can additionally be provided for the height restoring device to be detached from the insertion cannula before the pressure balloons are dilated, in particular in order to allow the height restoring device to expand unhindered.
Furthermore, it is advantageous if the insertion apparatus is introduced into a vertebral body or between vertebral bodies in the insertion configuration, i.e., with the stylet provided in the inner cannula, which stylet has the cutting tip at the distal end thereof. Accordingly, the insertion through an insertion catheter can be omitted since the insertion apparatus is introduced directly into the body using the stylet.
Further details and advantageous configurations of the invention can be found in the following description, on the basis of which embodiments of the invention are described and explained in more detail.
In the drawings:
The height restoring device 16 has a support body 18 which, in an insertion position as shown in
In order to transfer the height restoring device 16 into the expansion position, pressure balloons 20 which can be filled and which are indicated in
As is clear from
The support body 18 shown has a total of six carrier portions 26 running in the axial direction between the end portions 22 and 24. The carrier portions 26 are designed to be web-like or band-like and resilient, so that they bulge radially outward when shifted into the expansion position. Instead of six carrier portions 26, three, four, five, seven or more carrier portions 26 may also be provided.
As is clear from
As is clear from
When the pressure balloons 20 are dilated, i.e., when the support body 18 is shifted into the expansion position, the latching portions 32 slide along the counter-latching portions 28, with the latching being such that secure latching is ensured in every expansion position. If the pressure balloon 20 is further dilated and the support body 18 expands further as a result, a further relative movement takes place between the carrier portions 26 and the support portions 30, which relative movement is indicated by the arrows 24 in
Consequently, a type of free-running locking mechanism is implemented, with the result that the carrier portions 26 are allowed to move in the free-running direction, i.e., into the expansion position, but a return movement of the carrier portions into the insertion position is blocked due to the latching.
The height restoring device 16 shown in
As is clear from
As is clear from
In the insertion position shown in
As is clear from
It is also conceivable that the partial portions of the connecting webs 54.3 lying between the respective end portions 24.2 and 24.1 and the connection points 55 and running parallel in
It is also conceivable for the structure 53 to be designed differently, for example in the manner of expanded or support mesh.
As is clear from
As is particularly clear from
In the embodiment of a height restoring device 16 shown in
It is also clear from
In the embodiments shown in
The design of the carrier portions 26 having the connecting webs 54 and the connection points 55 substantially corresponds to the design as shown in
As can be seen from
The provision of an intermediate portion 106 of this kind allows the connecting webs 154 to be spread apart when shifted into the expansion position, as a result of which the distance between the partial support portions 30.1 and 30.2 is shortened overall and thus a relative movement between the carrier portions 26 and the support portions 30 during the movement into the expansion position is supported. The relative movement ultimately results in the latching of the respective latching portions 32 with the respective counter-latching portions 28.
A support body 18 with a distal and a proximal end portion 22, 24 is provided, the end portions 22, 24 being movable toward one another when shifted into the expansion position. The support body 18 or the one-piece outer part 52 thereof has radially outer support portions 26 and two connecting webs 54 each between the end portions 22.1, 24.1 thereof and the carrier portions 26. The carrier portions 26 are designed such that they move radially outward and act against the vertebral bodies when shifted into the expansion position. In contrast to the embodiment according to
The support body 18 or the one-piece inner part 50 thereof has—as is particularly clear from
As is clear from
The outer part 52 is also arranged with the end portions 22.1 and 24.1 thereof in an at least conditionally axially shiftable manner on the inner part 50. The carrier portions 26 move radially outward, in particular when shifted into the expansion position, as a result of which the distance between the end portions 22.1 and 24.1 and thus the entire length of the outer part 52 can be shortened. The inner part 50 and the outer part 52 are each provided as one-piece parts that are designed separately from one another.
The inner part 50 has at the proximal end 58 thereof a coupling portion 60 with which the height restoring device 16 can be detachably arranged at the distal end of an insertion cannula 14, as shown in
As is also clear from
In
As is clear from
First, the insertion apparatus 10, as shown in
In
The actuating apparatus 66 comprises three actuating portions 68, 70, and 72. The actuating portion 68 is fixedly arranged on the insertion cannula 14 so that the insertion cannula 14 can be rotated via the actuating portion 68 and moved in the axial direction.
As is clear from the sections according to
The insertion apparatus 10 shown in
Consequently, the stylet 80, the inner cannula 74, and the insertion cannula 14 can each be actuated independently of one another via the actuating apparatus 66 or the three actuating portions 68, 70, 72 thereof.
To introduce the height restoring device 16 into a vertebral body or between two vertebral bodies, the procedure may be as follows:
First, the insertion apparatus 10, as shown in
Thereafter, the actuating portion 72 can be rotated in particular by approximately 90° in relation to the actuating portions 68 and 70 in order to detach the axial movement coupling between the stylet 80 and the insertion cannula 14. For this purpose, in the position shown in
In a next step, corresponding instruments can be fed through the inner cannula 74 to the distal end of the insertion cannula 14 or the height restoring device 16. These instruments may be, for example, biopsy devices for taking tissue samples, or endoscopes or video endoscopes.
In order to move the height restoring device 16 into the expansion position, in a next step, pressure balloons 20 are brought through the inner cannula 74 into the cavity 62 of the height restoring device 16. The insertion cannula 14 may comprise or form a line via which the pressure balloons 20 can be brought into the height restoring device 16 and filled with a pressurized fluid, so that the height restoring device 16 or the support body 18 can assume the expansion position. Through the insertion cannula 14, the pressure balloons 20 can also be removed and hardening filling material can be introduced into the expanded support body 18.
Before the pressure balloons 20 are acted upon with the fluid, as shown in
In a next step, the pressure balloons 20 can then be acted upon with the pressure fluid, so that the height restoring device 16 assumes the expansion position thereof, as shown in
After the height restoring device 16 has assumed the final expansion position thereof, the pressure balloons 20 can be removed through the insertion cannula 14 in the proximal direction. Furthermore, the actuating portion 70 together with the inner cannula 74 can also be removed in the proximal direction.
Ultimately, bone filling material or bone cement can be introduced through the insertion cannula 14 into the cavity 62 formed by the height restoring device 16. After the bone filling material has been introduced, the actuating portion 68 can be removed from the body together with the insertion cannula 14 in the proximal direction. However, it is also conceivable for the expansion position to be permanently secured with a fixing screw 90, as shown in
However, before the height restoring device 16 expands, a cavity can first be created in the vertebral body or between the vertebral bodies. If it turns out that the cavity as such is stable enough, the procedure can be in such a way that the cavity is filled directly with bone filling material or bone cement through the insertion cannula 14 without the height restoring device 16 being introduced into the cavity and expanded there. A procedure of this kind has the advantage that it is possible to align and restore the height of the spinal column without the height restoring device 16 remaining in the body.
In order to create such a cavity, the insertion device 10 can be pulled back slightly in the proximal direction after the stylet 80 has been removed, so that a certain cavity remains in the region where the height restoration is to take place. In a next step, one or more pressure balloons 20 can be introduced through the outer cannula 14 into the cavity located in the distal direction behind the height restoring device 16. Thereafter, the pressure balloons 20 can be dilated, as a result of which the height of the vertebral bodies is restored and a cavity is formed in the vertebral body, or between the vertebral bodies. In a next step, the pressure balloons 20 can be removed from the cavity and pulled back into the height restoring device 16 in the distal direction. If the cavity turns out to be stable enough, there is no need to insert and expand the height restoring device 16 into the cavity; bone filling material or bone cement can be introduced directly. However, should the cavity not prove to be sufficiently stable, the height restoring device 16 can be inserted into the cavity by being pushed distally and expanded there before bone filling material is introduced through the insertion cannula 14 into the vertebra or between the vertebral bodies.
The height restoring device 16 shown in
The actuating apparatus 116 comprises, corresponding to the actuating apparatus 66 of the insertion apparatus 10, an actuating portion 68 which is fixedly connected to the outer cannula 14, an actuating portion 70 which is fixedly connected to the inner cannula 74, and an actuating portion 72 which is non-rotatably connected to the stylet 80 via a hexagon 73.
As is clear from
As is also clear from
As is clear from
After the height restoring device 16 has been placed, as shown in
The height restoring device can also be introduced into the expansion site by first creating access to the expansion site according to the following steps S1 to S8, as shown in
S1: introducing an access instrument, in particular via a pedicle, into the expansion site,
S2: placing a pin guide at the expansion site, in particular through the access instrument, and removing the access instrument,
S3: inserting a drill cannula via the pin guide, the drill cannula comprising a cannula and a drill that can be detached from the cannula, and drilling open the vertebral body at the expansion site,
S4: removing the drill, so that the cannula remains in the body and access to the expansion site is established.
Creating the access first and then inserting the height restoring device through the access is advantageous in particular when the insertion apparatus does not comprise a stylet having a cutting tip, with which stylet the height restoring device can be introduced directly into a vertebral body or between adjacent vertebral bodies.
In this case, the cannula has an inner diameter that is dimensioned so that the height restoring device can be inserted through the access formed by the cannula into the expansion site.
Furthermore, according to S5, it may be provided that at least one pressure balloon is inserted through the cannula into the expansion site and is dilated to widen the expansion site and to create a cavity before the height restoring device is inserted into the access. After the expansion site has been widened and the at least one pressure balloon has been removed, the height restoring device can be inserted according to S6 through the access into the expansion site. After the insertion of the height restoring device into the expansion site, pressure balloons placed in the height restoring device can be dilated according to S7 for transferring the height restoring device into the expansion position, and the pressure balloons can be removed according to S8 after the height restoring device has reached the expansion position. Thereafter, according to S8, bone cement can be introduced through the cannula into the expansion site, and the cannula can be removed.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2020 102 100.3 | Jan 2020 | DE | national |
| 10 2020 113 300.6 | May 2020 | DE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/052205 | 1/29/2021 | WO |
