DEVICE FOR SPINAL SURGERY, CORRESPONDING GUIDE SLEEVE AND KIT WITH GUIDE SLEEVE

20180344480 ยท 2018-12-06

    Inventors

    Cpc classification

    International classification

    Abstract

    To reduce the stress of a patient as much as possible during a percutaneous spine surgery for inserting an interbody cage between two vertebrae, between which the intervertebral disk was damaged and was therefore removed, a guide sleeve is provided for the spine surgery, which is characterized by a non-cylindrical jacket. A kit is further provided for spine surgery with at least one guide sleeve of the above-mentioned type and a dilator, having an outer contour that is adapted to the contour of the lumen of the guide sleeve. A kit for spine surgery is further provided including a guide sleeve and an interbody cage, which is to be inserted through this guide sleeve. The lumen of the guide sleeve is adapted to a maximum cross-sectional contour of the interbody cage.

    Claims

    1. A device for spine surgery, the device comprising: at least one guide sleeve; and at least one dilator having an outer contour that corresponds to the inner contour of the at least one guide sleeve, wherein the guide sleeve has a non-cylindrical jacket.

    2. A device in accordance with claim 1, wherein the guide sleeve has two mutually opposite broad sides with a breadth greater than a breadth of narrow sides connecting the two mutually opposite broad sides.

    3. A device in accordance with claim 2, wherein one of the broad sides is flat.

    4. A device in accordance with claim 2, wherein one of the broad sides is bent convexly outwards and has a radius of curvature of 11 mm to 12.5 mm.

    5. A device in accordance with claim 2, wherein a bend angle of transition between each broad side and each narrow side is between 3 mm and 4.5 mm.

    6. A device in accordance with claim 2, wherein the narrow sides have distally directed projections projecting over the broad sides.

    7. A device in accordance with claim 6, wherein the projections are tapered towards a free end thereof and are round at the free end.

    8. A device in accordance with claim 2, wherein the narrow sides have a greater thickness than the broad sides, the thickness of the broad sides being 0.8 mm to 1.2 mm and/or the thickness of the narrow sides being greater than 1.2 mm to 1.7 mm.

    9. A device in accordance with claim 2, wherein the sleeve has grooves extending at right angles to a sleeve longitudinal axis in a proximal area of it's the narrow side of the sleeve.

    10. A device in accordance with claim 1, wherein openings are located diametrically opposite in a device proximal area.

    11. A device according to claim 1, wherein a lumen of the dilator has a cylindrical configuration.

    12. A device according to claim 1, wherein the dilator has grooves extending at right angles to a dilator longitudinal axis in a proximal area of an outer side.

    13. A guide sleeve, for spinal surgery that forms a part of a kit, the guide sleeve comprising a non-cylindrical jacket.

    14. A guide sleeve in accordance with claim 13, wherein the guide sleeve comprises two mutually opposite broad sides with a breadth greater than a breadth of two narrow sides connecting the two mutually opposite broad sides.

    15. A guide sleeve in accordance with claim 14, wherein one of the broad sides is flat.

    16. A guide sleeve in accordance with claim 14, wherein one of the broad sides is bent convexly outwards, especially with a bend angle of 11 mm to 12.5 mm.

    17. A guide sleeve in accordance with claim 14, wherein the bend angle of the transition between a broad side and a narrow side is between 3 mm and 4.5 mm.

    18. A guide sleeve in accordance with claim 14, wherein the narrow sides distally have projections projecting over the broad sides.

    19. A guide sleeve in accordance with claim 18, wherein the projections taper to their free end and are rounded at the free end.

    20. A guide sleeve in accordance with claim 14, wherein the narrow sides have a greater thickness than the broad sides, the thickness of the broad sides being 0.8 mm to 1.2 mm or the thickness of the narrow sides being greater than 1.2 mm to 1.7 mm or both the thickness of the broad sides being 0.8 mm to 1.2 mm and the thickness of the narrow sides being greater than 1.2 mm to 1.7 mm.

    21. A guide sleeve in accordance with claim 14, wherein the sleeve has grooves extending at right angles to a longitudinal axis in a proximal area of an outer side thereof, on the narrow side of the sleeve.

    22. A guide sleeve in accordance with claim 14, wherein the guide sleeve has openings located diametrically opposite in a proximal area.

    23. A spine surgery kit comprising: a guide sleeve; and an interbody cage to be placed through the guide sleeve, wherein a lumen of the guide sleeve is adapted to a maximum cross-sectional contour of the interbody cage.

    24. A spine surgery kit in accordance with claim 23, further comprising at least one dilator having an outer contour that corresponds to an inner contour of the at least one guide sleeve, wherein the guide sleeve has a non-cylindrical jacket.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0017] In the drawings:

    [0018] FIG. 1.1 is a lateral view of a guide sleeve of the device according to the present invention with distal projections protruding into the intervertebral disk space between two vertebrae;

    [0019] FIG. 1.2 is an end face of the guide sleeve according to FIG. 1 with an interbody cage inserted;

    [0020] FIG. 1.3 is a perspective view of the embodiment according to FIG. 1 with an interbody cage inserted into the guide sleeve at the proximal end;

    [0021] FIG. 2 is a schematic view of a typical interbody cage in a perspective view;

    [0022] FIG. 3 is a top view of the proximal end of a guide sleeve with a cage inserted;

    [0023] FIG. 4.1 is a perspective view of a guide sleeve, viewed obliquely from its distal end;

    [0024] FIG. 4.2 is a lateral view of the guide sleeve according to FIG. 6.1;

    [0025] FIG. 5.1 is a perspective view of a non-cylindrical dilator of a device according to the present invention, which dilator is used directly within the guide sleeve;

    [0026] FIG. 5.2 is a lateral view of the dilator according to FIG. 5.1;

    [0027] FIG. 6.1 is a top view of the device according to the present invention with a guide sleeve in the kit with two dilators inserted into this guide;

    [0028] FIG. 6.2 is a lateral view of the device of FIG. 6.1 with the guide sleeve in the kit with two dilators inserted into this guide;

    [0029] FIG. 6.3 is a perspective view from the proximal end of the device of FIG. 6.1 with the guide sleeve in the kit with two dilators inserted into this guide;

    [0030] FIG. 6.4 is a perspective view towards the distal end of the device of FIG. 6.1 with the guide sleeve in the kit with two dilators inserted into this guide;

    [0031] FIG. 6.5 is an enlarged view of the distal end of the kit according to FIGS. 6.1 through 6.4; and

    [0032] FIG. 7 is a view to the alternative posterolateral access or anterolateral access to the intervertebral disk space.

    DESCRIPTION OF THE PREFERRED EMBODIMENTS

    [0033] Referring to the drawings, In case of injuries to intervertebral disks, in which these must be partially and especially completely removed, at least one interbody cage 2 is to be inserted between the vertebrae 1.1, 1.2 located adjacent to the affected intervertebral disk to stabilize the spine.

    [0034] An interbody cage 2 may have different contours. A cage 2 as is shown, for example, in FIG. 2 in a perspective view proved to be suitable. Such a cage has a stable outer frame 2.1 and an inner, porous, grid-like or net-like structure 2.2, which enables the bone of the adjacent vertebrae 1.1, 1.2 to grow into this structure in order thus to establish a firm connection.

    [0035] As is seen, the cage tapers in the longitudinal direction towards its distal end. The upper surface 2.3 is bent over the width convexly with a relatively large radius of curvature. This makes it possible to adapt the relative positions of the vertebrae over the cage 2. By contrast, the lower surface of the cage, just like the side walls, does not have an arc-shaped configuration over its breadth or height but has an at least nearly flat configuration.

    [0036] As this can be see in FIGS. 1.1 through 1.3, such an interbody cage is inserted through a guide sleeve 3 into the intervertebral area or the former intervertebral disk space.

    [0037] As can be seen especially also in FIGS. 3 through 4.2, the guide sleeve 3 has a non-cylindrical jacket 3.1 over an entire jacket length and an (inner) lumen 3.2 with a non-cylindrical, constant lumen cross section. The cross-sectional contour of the lumen 3.2 of the guide sleeve 3 is adapted to the maximum cross-sectional contour of the interbody cage 2 (FIG. 2) to be inserted, i.e., to the cross-sectional contour thereof at a short distance in front of the proximal end of the cage 2 with sufficient tolerance.

    [0038] The jacket 3.1 and the wall of the guide sleeve 3 have essentially mutually opposite upper and lower broad sides 3.3, 3.4 as well as narrow sides 3.5, 3.6 connecting those, namely, two mutually opposite narrow sides 3.5, 3.6 in this exemplary embodiment.

    [0039] The lower broad side 3.4 essentially has, just like the narrow sides 3.5, 3.6, a flat configuration on the inner side towards the lumen, and the transition between the broad side 3.4 and the narrow sides 3.5, 3.6 does not have sharp angles, but is rounded, the radius of curvature of the transition between the lower broad side 3.4 and the narrow sides 3.5, 3.6 being 4 mm here.

    [0040] The upper broad side 3.3 has an outwardly convexly bent configuration (i.e., it is not flat) over the breadth of the guide sleeve 3. The radius of curvature of the upper broad side is 12 mm here. The sleeve has transverse grooves 3.8 on its proximal outer side as well as diametrically opposite wall openings 3.9. The grip for fingers of the surgeon or tools is improved by this configuration.

    [0041] As can likewise be seen especially in FIG. 3, the wall thickness of the upper and lower broad sides 3.3, 3.4 is smaller than the wall thickness of the narrow sides 3.5, 3.6. While the wall thickness of the upper and lower broad sides 3.3, 3.4 is typically approx. 1 mm in the exemplary embodiment shown, the wall thickness of the narrow sides 3.5, 3.6 is approx. 1.5 mm (the view in FIG. 3 is an enlarged view). Projections 3.7, which are distal projections, are formed at the distal end of the narrow sides 3.5, 3.6 (FIGS. 1, 4.1 through 4.5). These are used, on the one hand, for a firm anchoring of the guide sleeve between the two vertebrae 1.1 and 1.2 and, on the other hand, also for dilating the intermediate space, so that the cage 2 can be inserted between the two vertebrae 1.1, 1.2. Since the projections 3.7 form an extension of the narrow sides 3.5, 3.6, higher stability is imparted by the greater wall thickness of the narrow sides 3.5, 3.6 on the projections 3.7, so that these can fulfill their task of securely anchoring the guide sleeve 3 and dilating the intermediate space between the vertebrae 1.1, 1.3 with certainty.

    [0042] The interbody cage 2 and the guide sleeve 3 together form a kit for spinal surgery. Their cross-sectional contour, the outer contour of the cage 2 and that of the lumen of the guide sleeve 3, are adapted to one another.

    [0043] FIGS. 5.1 and 5.2 show a dilator 4, which comes to lie directly within the guide sleeve 3 when the latter is pushed over it. The outer contour of the dilator 4 located directly within the guide sleeve 3 is accordingly adapted to the lumen of the guide sleeve 3 with narrow tolerances. This means that the lower outer broad side of the dilator, just as the outer narrow sides thereof, have a largely flat configuration, while the upper outer broad side is bent convexly outwards. The outer cross-sectional contour of the dilator 4 is constant over the largest part of its length; only the distal end 4.1 of the dilator 4 tapers conically, as is common in case of such dilators.

    [0044] As can be seen in FIG. 5.1 especially at the rightdistalend of the dilator 4, in or also at the leftproximalend in FIG. 6.3, the inner lumen of the dilator 4 is cylindrical, i.e., the proximal and distal inlet and outlet openings are circular. The dilator 4 also has transverse grooves 4.3 on its proximal outer side.

    [0045] FIGS. 6.1 through 6.5 show an (insertion) kit for spinal surgery with a guide sleeve, as was described above, and with two dilators shown, namely, the dilator 4 described above especially with reference to FIGS. 5.1 and 5.2 and another dilator 5, which comes to lie within the dilator 4 or is pushed over the dilator 4.

    [0046] The additional dilator 5 shown in FIGS. 6.1 through 6.5, which is located on the inside, has, correspondingly to the cylindrical inner contour of the dilator 4, a cylindrical outer contour andlikewise also a cylindrical inner contour , as this is common in such dilators. The two individual kits comprising the parts 2, 3, on the one hand, and 3, 4, 5, on the other hand, form a common surgical kit.

    [0047] The access to the intermediate space (intervertebral disk space) between two vertebrae 1.1, 1.2 by means of the device according to the present invention is possible both posterolaterally P and anterolaterally A, preferably with an access angle of 30 to 60 each and preferably 40 to 50, always in relation to thecentralsagittal plane S or in thehorizontalsagittal axis located in this plane at the top in the rear or in the front from the side, as this is shown in FIG. 7. The posterolateral access may be preferably along the outer lateral surface of the processus spinosus 1.3 of the vertebra 1.1.

    [0048] It is achieved due to the non-cylindrical configuration according to the present invention of the guide sleeve according to the present invention that, on the one hand, even though an interbody cage can be inserted through it, the stress on the tissues of a patient in the area in which the guide sleeve 3 is inserted between the skin surface and the intervertebral disk space, especially in the direction in which the spine extends, is stressed, on the other hand, as little as possible, because the height of the guide sleeve can be substantially reduced due to the configuration of the guide sleeve according to the present invention compared to conventional cylindrical guide sleeves (with a circular cross section).

    [0049] While specific embodiments of the invention have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.