EP1824403A1 - Implant destine au traitement de la stenose du canal rachidien lombaire - Google Patents

Implant destine au traitement de la stenose du canal rachidien lombaire

Info

Publication number
EP1824403A1
EP1824403A1 EP05826585A EP05826585A EP1824403A1 EP 1824403 A1 EP1824403 A1 EP 1824403A1 EP 05826585 A EP05826585 A EP 05826585A EP 05826585 A EP05826585 A EP 05826585A EP 1824403 A1 EP1824403 A1 EP 1824403A1
Authority
EP
European Patent Office
Prior art keywords
spacer
retaining element
implant according
retaining
implant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP05826585A
Other languages
German (de)
English (en)
Inventor
Horst Döllinger
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
TIKOM GmbH
Original Assignee
Dollinger Horst
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Dollinger Horst filed Critical Dollinger Horst
Publication of EP1824403A1 publication Critical patent/EP1824403A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7065—Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor

Definitions

  • the present invention relates to an implant according to the preamble of claim 1 for the treatment of lumbar spinal stenosis with a spacer which is attachable between the spinous processes of two adjacent vertebral bodies.
  • Spinal canal stenosis is any form of constriction of the spinal canal through which the spinal cord passes, excluding inflammation, tumors and complete disc herniation. Most commonly, spinal canal stenosis is found in the lumbar region, ie in the lumbai region, but it also occurs in the area of the thoracic and cervical spine. The most common cause of acquired spinal stenosis is degenerative changes to the spine. Such degenerative changes of the bone and cartilage apparatus occur more frequently, especially in older patients. Therapeutically, one initially intervene with analgesic drugs, such as non-steroidal anti-inflammatory drugs, pain-relieving or by means of bandages or corsets seek deletion bring about.
  • analgesic drugs such as non-steroidal anti-inflammatory drugs, pain-relieving or by means of bandages or corsets seek deletion bring about.
  • Implants for the treatment of the lumbar spinal canal stenosis are known from EP-O '322' 334 A and FR-2'724'554 A. Particularly advantageous is in particular a solution which has become known from WO99 / 21501.
  • the implant disclosed herein works with a central body on which a sleeve is rotatably mounted eccentrically. On both sides of this sleeve, which is oval in cross-section, wings are provided as arresting means which must rest on the central body on both sides of the spinous processes. This size adjustment by the oval cross-section spacer requires that more space is created and also the design is designed so that on both sides of the spine the surgeon must have access.
  • This object solves an implant of the type mentioned with the features of the characterizing part of claim 1, with a unilateral supply can be realized.
  • FIG. 1 shows the implant arranged between two adjacent spinous processes of a vertebral body in its installed position
  • Figure 2 shows the implant according to the invention alone in the assembled state in a longitudinal section.
  • Figure 3 shows a realized as rolling elements spacers in side view
  • Figure 4 shows the same spacer in the view from above.
  • Figure 5 shows a variant of the spacer with a pointed head, again in side view, while
  • Figure 6 shows the same spacer with a view of the pointed end, which is the introduction side
  • FIG. 7 shows the same spacer with respect to the rear end
  • FIG. 8 again shows the same spacer in the view from above.
  • FIG. 9 shows a variant of the spacer with a first retaining element mounted therein
  • Introductory position and Figure 10 shows the same spacer of Figure 9 with the first retaining element in a slightly advanced position, as well
  • FIG. 12 shows a first retaining element in one piece
  • FIG. 13 again shows in simplified form a spacer with a partially performed first retaining element, this being a two-part retaining element, and FIG. 13
  • FIG. 14 shows the same element according to FIG. 13 in FIG.
  • FIG. 15 shows an alternative first retaining element in a partially cut state in a longitudinal section
  • FIG. 16 shows the same two-part element according to FIG. 15 in FIG.
  • Figure 17 shows a second retaining element in the simplest embodiment in perspective view
  • FIG. 18 shows a part of a spacer with a second retaining element which can be attached thereto in a side view.
  • Figure 19 shows symbolically and simplified a spacer with two inserted jaws of a pair of pliers, which serves for the introduction of the spacer in the side view and
  • Figure 20 the same situation in the supervision -from the front.
  • Figure 21 shows a similar spacer with a differently designed insertion pliers whose jaws are designed to scrape past each other.
  • FIG. 22 shows the situation according to FIG. 21 in the plan view of the tip of the clamping jaws of the forceps or on the introduction side of the spacer.
  • FIG. 23 shows a detailed embodiment according to the variant according to FIG Figures 15 to 17 in a perspective view in the insertion position
  • Figure 25 shows the embodiment of Figure 23 in the inserted end position, again in perspective and
  • Figure 27 shown in the insertion position in a perspective view.
  • FIG. 1 shows the situation on a patient.
  • a two adjacent vertebral bodies, or Vertebrae are shown. Their spinous processes are designated B.
  • the spinal canal C runs between the vertebral bodies A and the spinous processes B.
  • E represents the exit points of the nerve roots.
  • the interspinous ligament D runs between two adjacent spinous processes B. This is traversed by a spacer 10 and held in position by a first retaining element 20 on the one side and secured by a second retaining member 30 on the other side against traversal displacements. This backup will but hardly effective, since the spacer 10 is designed waisted and thus centered between the two spinous processes B.
  • FIG. 28 shows the same solution as in FIG. 27, but in an intermediate position during installation, the implant being shown in a view. And finally shows
  • Figure 29 shows the solution in the installed end position.
  • the Baastrup sign refers to the touch of two adjacent spinous processes.
  • the supraspin ligament bulges toward the spinal canal and causes spinal canal stenosis.
  • it can then lead to a disc protrusion that further narrows the spinal canal.
  • the spinous processes are pressed apart and the compressed interspinous ligament is relieved, so that the supraspin ligament reforms and the stenosis is released.
  • Implant as a whole is designated 1. It exists in
  • the main element is one Spacer 10 which is preferably designed as a rolling element. In principle, this can be a cylindrical element. In the examples shown here, the spacer 10 is oval in cross-section, resulting in the two different sizes of the spacer in Figures 3 and 4, depending on whether the spacer 10 in the side view, as shown in Figures 2 and 3, or in the top view, as shown in Figure 4.
  • the spacer 10 here has a continuous interior 11. This may not be rotationally symmetrical and is rectangular in cross section in the example shown here. Accordingly, in turn, in the side view of Figure 3, the interior is larger and shown in Figure 4 smaller.
  • the cross-sectional shape of the inner space 11 selected here is a preferred form for manufacturing reasons, but the inner space can in principle have virtually any cross-sectional shape as long as the cross-sectional shape is not round.
  • the spacer 10 or the rolling elements has a front side 12 and a rear side 13. As the front side, the front side of the insertion side is referred to, while the side opposite the insertion side is referred to as the rear side 13.
  • the outer lateral surface of the spacer 10 has a sidecut 15. This sidecut is intended to cause self-centering between the two adjacent spinous processes when the spacer is installed. In principle, the two end faces 12 and 13 of the spacer 10 can be designed plan. This results in a certainly extremely inexpensive production.
  • the front side 12 in the insertion direction is provided with a head, as shown by most of the embodiments to be described below, and in particular as shown in FIGS. 5 to 8.
  • This head 17 is divided into two partial peaks 18 practically. The division is made by a crossing cut 18 '.
  • the transverse cut 18 ' serves for the rotationally secured positioning of a first retaining element 20, which will be described later in detail, which comes to rest at least partially in this transverse cut.
  • the transverse cut 18 is provided with preferably rounded ramps 18 ".
  • the spacer 10 may be designed on the back 13 as a simple planar surface, as shown in Figures 3 and 4, but it is possible to provide the back with a groove-shaped recess 19, the positive and rotationally secured positioning of a second retaining element 30th serves.
  • both the transverse cut 18 'and the groove-shaped recess 19 has a different shape have, if appropriate, the retaining elements are adapted thereto.
  • the first or front retaining element 20 can also have a wide variety of shapes.
  • the shape of the retaining element, in particular the first retaining element is essentially determined by the fact that this must be designed so .that it can be passed through the interior 11 of the spacer 10 therethrough. Accordingly, the first retaining element 20 is at least approximately the same design as the cross section of the inner space 11.
  • the first retaining element 20 consists of one piece. It has substantially the shape of a flat bar and is pivotally connected to a pulling and / or pushing element 40. The pivotable connection is realized by an axle 41.
  • a receiving groove 21 is formed.
  • the head 17 of the spacer 10 can be asymmetrical or, as shown in FIGS. 10 and 11, symmetrical, as already shown in the earlier figures.
  • the first retaining element 20 has terminal, inclined end faces 22. These faces 22 open into cutting edges 23. When piercing the first retaining element 20 through the interior 11, the inclined end faces with their cutting edges 23 sever the interspinous ligament.
  • the retaining element 20 in a different form, as shown in FIG 12.
  • it is a one-piece first retaining element 20.
  • This also has an approximately rod-like shape.
  • the cross section However, this first retaining element is smaller than the cross section of the inner space 11. The full cross section it reaches only in the central region, where the rod-shaped part 25 is provided with a bracket 26.
  • the bracket 26 serves to support the already mentioned pivot axis 41. At this pivot axis 41 turn the tension and / or pressure element 40 is formed.
  • a torsion spring 42 is also mounted on the pivot axis 41, which rotates the rod-shaped part 25 of the retaining element 20 after complete penetration through the interior 11 of the spacer 10 relative to the tension and / or pressure element, so that when retracting the first retaining element 20 is not pulled back into the interior.
  • FIGS. 13 to 16 show two variants of a first retaining element 20, which is designed in two parts.
  • the rod-shaped part 25 is divided into two partial rods 24.
  • the first retaining element 20 is designed so that the two partial rods 24 can be inserted in advance with their freely movable ends.
  • the two part rods are pivotally held on the same axis 41, on which also the tension and / or pressure element 40 engages.
  • de two part rods 24 must be spread apart by means of a relatively strong spring, which then retract only under relative large tractive forces allowed.
  • the great advantage of such a solution is that the unilateral implantation is reversible and consequently, in the case of a postoperative procedure, if necessary, the entire implant can in turn be removed unilaterally.
  • the unilateral expansion is no longer present in the embodiment according to FIGS. 14 and 16. Otherwise, however, the first retaining element 20 is designed very similar. While in the embodiment according to FIGS. 13 and 14, the pivot axis 41 follows the two part bars 24 in the direction of insertion, here the hinge is laid forwards and thus lies forward in the direction of penetration. Otherwise, the element has the same parts and these are provided with the same reference numerals. Although not shown here, the spacer 10 can of course be provided on the front side with an approximately rounded outlet section, so that even during the pushing through of the folded two-part retaining element 20 in the final phase of the penetration, a certain spreading can already take place.
  • the second retaining element 30 is reasonably always designed in one piece. This also has an approximately rod-like shape.
  • this second retaining element can be particularly simple.
  • it consists of the rod-shaped body 31 with a Consoles attachment 32.
  • the console attachment 32 is designed in the form that it can be positively applied from the rear side, the console 32 positively and non-rotatably in the interior 11 of the spacer 10 recording.
  • the rod-shaped part 31 and the bracket 32 are penetrated by a centri Service bore 33 through which the tension and / or pressure element 40 can be guided.
  • the bracket 26 on the first retaining element 20 can also be designed such that it engages in the interior 11 of the spacer in a form-fitting and rotationally secured manner.
  • the tension and / or pressure element 40 passes through as mentioned with its rod-shaped part 43, the second retaining member 30 and protrudes on the rear side.
  • the rod-shaped part 43 has a thread 44. On this thread 44, a retaining nut 45 is screwed. A threaded hole passing through the retaining nut 43 to the center serves to insert a locking screw 46.
  • FIG. 1 a variant of the second or rear retaining element 30 is shown in FIG. This again has a rod-shaped body 31 and also a console attachment 32, which takes place in the interior of the spacer 10.
  • a guide head 34 is additionally formed on the rear side, the console attachment opposite. This guide head can guide the rod-shaped part 43 of the tension and / or pressure element 40.
  • the through hole 33 may be configured in this case as a threaded hole. However, this is not mandatory.
  • the locking screw 46 may be designed as a grub screw which is provided with a tip which enters the rod-shaped part 43 in a form-fitting manner. This can practically occur a cold welding. This is an extraordinarily secure connection feasible.
  • the invention likewise comprises a forceps preferred for setting the implant. This is overall not shown, but only their jaws 50th Die
  • Pliers jaws 50 are designed so that they are in the fully superimposed state through the interior 11 of the
  • Spacer 10 can be guided through.
  • the jaws 50 have jaw tips 51. These jaw tips 51 complete the head 17 of the spacer when the
  • Pliers jaws introduced and spread in this case. If the spacer is placed on the forceps jaws, the spacer is guided with the forceps from one side between two adjacent spinous processes, penetrating the intraspinal ligament. To facilitate the implementation, the surgeon will produce the passage opening by means of a scalpel, at least slit-like. On the jaws 50 also retaining beads 52 are formed, which make it impossible to slippage of the spacer on the jaws 50. The forceps jaws 50, however, also hold the spacer 10 in a force-locking manner and, with their outer surfaces, rest on the inner surfaces of the inner space 11.
  • FIGS. 21 and 22 show a possible variant of the pliers.
  • the two jaws of the pliers slide over each other in a scissor-like manner.
  • the two jaws 50 in turn have jaw tips 51 which complement the head 17 of the spacer 10 to a point.
  • the jaw tips 51 can be perfectly adapted to the shape of the head.
  • This solution allows a more closed in the direction of penetration of the tip than in the aforementioned embodiment of the forceps.
  • the forceps certainly represent a preferred embodiment for the application of the implant, it is of course also possible to realize differently designed introduction means.
  • the embodiment described here merely serves to disclose the full implementation of the invention, thanks to which it is possible to only unilaterally expose two adjacent spinous processes in the region of a lumbar spinal canal stenosis to make what then unilateral installation, the implant can be placed.
  • FIGS. 23 to 26 show a modified version compared with the previously described embodiments, this implant for treating lumbar spinal canal stenosis solves the same object of the invention, namely to create an implant which can be inserted by a unilateral procedure.
  • the first retaining element 20 is guided through the spacer 10 in all the embodiments described above, a solution is shown in which the first, front retaining element 20, as previously described in the embodiments according to Figures 13 to 16, is made in two parts , The two parts of the retaining element 20 are designated here by the reference numerals 121 and 122.
  • the surface lying in front during insertion of the spacer 10 between the two spinous processes B is shown here as head 117.
  • the head 117 has here a gable-shaped configuration.
  • the gable-shaped head 117 has a transverse incision 118.
  • This incision 118 also has a gable-like shape, the tip of which is, however, ground down.
  • a planar partial surface 112 remains.
  • the two parts 121 and 122 of the first, two-part retaining element 20 are held pivotably on the tension or pressure element 40 via an axis 123.
  • the Axis 123 passes through the tension or pressure element 40 and the two parts 121 and 122 embrace the tension and / or pressure element 40 configured as a rod.
  • the first retaining element 20 no longer needs to be guided through the spacer 10 it also not mandatory that the interior 11 must have a deviating from the round shape shape.
  • the rotation is obtained solely by the positive-locking mounting of the two-part first retaining element, which is already in the insertion position, integral in the head 117 of the spacer 10 when setting the implant.
  • the tension and / or pressure element 40 is realized as a round rod, for example as a threaded rod, this is not mandatory.
  • the tensile and / or pressure element can certainly, as before, have a non-round shape and accordingly, of course, the interior 11 would again have the non-round shape.
  • the embodiment shown here is relatively easy to handle and design. In the position, as shown in Figures 23 and 24, the spacer 10 can be inserted while at the same time the second, rear retaining member 30 is held secured on the tension and / or pressure element 40 that the relative positions, as in the figures 23 and 24 are shown. Accordingly, the implants can be delivered in this pre-assembled state. Upon introduction, the pressure can be applied directly to the tension and / or pressure element 40.
  • the spacer 10 in the form shown here has substantially the shape of an octagon rounded at the corners, this is of course not mandatory. Again, the spacer 10 may in principle have the shape of a rolling element. Likewise, the spacer 10, as the examples described above, have a sidecut to exert a self-centering effect.
  • a rolling element is understood to mean a spacer which is axisymmetric, but not rotationally symmetrical. The term rolling element only expresses that the spacer in its position of use also serves to allow the spinous processes to roll on it during movement.
  • FIGS. 27 to 29 makes use of the idea of designing the entire implant, which is designated here by 201, in such a way that in an insertion position the implant 201 is larger in the longitudinal direction than in the installed state.
  • additional space is created to more easily accommodate the first, front retaining element 220 in the spacer 210 during the introduction phase, whereby this can also be made more optimal.
  • the spacer 210 then has an inner chamber 211 which has a longitudinal slot which extends over the entire length of the roller 210 until the ⁇ end portion which forms the head of the 217th In this open space, represents the interior 211, can now easily arrange the first, front retaining element 220.
  • the first, front retaining element 220 is again divided into two, and the two parts 221 and 222 of the first retaining element 220 are pivotally held about an axis 223.
  • the axis 223 is mounted from the center of the spacer 210, so that the first, front retaining element is divided into a long retaining element part 221 and a short retaining element part 222.
  • the implant 201 comprises a tensile and / or pressure element, which is designated here by 240.
  • This tensile and / or pressure element 240 comprises an insertion part
  • Retaining member 231 and a lower retaining member portion 232 is made. Both parts are integrally formed on the insertion part 241. They are diametrically opposed to each other. In the introduction phase of the implant 201, the insertion part 241 is held in an extended position, as shown in FIG. The insertion part 241 has below and above each a saddle-like sidecut
  • a central slot 243 is formed in the insertion part 241 in the spacer 210.
  • the clamping screw 244 serves to secure the insertion part 241 in a desired pull-in or extended position of the insertion part 241 in the spacer 210. Thanks to the inner space 211 designed as a longitudinal slot, the spacer 210 is located in the end region where the clamping screw 244 is arranged. slightly compressible. During the insertion phase, the insertion part 241 is clamped in the extended position by means of the screw 244.
  • a longitudinal groove 245 formed below the elongated hole 243 is parallel to this running a longitudinal groove 245 formed.
  • the plunger 250 has a nose 251 and a front pressure surface 252.
  • the longitudinal groove 245 has a locking groove 246 arranged in the front region, while the tappet 250 has a bead 253 which, in the position according to FIGS.
  • the plunger 250 also has at its end a longitudinal slot 254 which extends beyond the region at which the bead 253 is attached. As a result, the end portion of the plunger 250 can be resiliently compressed so that the bead 253 can be pushed out of the locking groove 246 as the insertion portion 241 is pushed into the spacer 210.
  • This inserted position which corresponds to the installation position of the implant, is shown in FIG. In this position, the plunger 250 is fully inserted in the longitudinal groove 245. This can therefore be seen in FIG. 29, because again the spacer 210 is shown transparent.
  • the bead 253 is now in a rear position on which optionally again a locking groove may be present, which, however, is not mandatory and is not shown in the other figures.
  • the solution shown in FIGS. 27 to 29 can, if appropriate, also be unilaterally removed for a postoperative procedure.
  • the locking screw fixed in the end position 244 is released again and then by means of a tool which comprises two parallel, interconnected rods, introduced by two mounted from the end side insertion holes 247.
  • a vertebral body, vertebrae A vertebral body, vertebrae

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un implant (201) destiné au traitement de la sténose du canal rachidien lombaire, comportant un espaceur (210) présentant un espace intérieur allongé (211) dans lequel un insert (214) peut être introduit. Un premier élément de retenue (210) est logé dans l'espaceur (210) à l'état introduit. La première pièce de retenue (220) peut être déployée par introduction de l'insert (241) tandis qu'un deuxième élément de retenue arrière (230), moulé sur l'insert, vient s'appuyer contre les saillies vertébrales. L'implant (210) peut ainsi être introduit unilatéralement et l'on réduit les risques de recours à des interventions postopératoires.
EP05826585A 2004-12-16 2005-12-16 Implant destine au traitement de la stenose du canal rachidien lombaire Withdrawn EP1824403A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CH20842004 2004-12-16
CH13442005 2005-08-16
PCT/IB2005/003799 WO2006064356A1 (fr) 2004-12-16 2005-12-16 Implant destine au traitement de la stenose du canal rachidien lombaire

Publications (1)

Publication Number Publication Date
EP1824403A1 true EP1824403A1 (fr) 2007-08-29

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ID=36129990

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05826585A Withdrawn EP1824403A1 (fr) 2004-12-16 2005-12-16 Implant destine au traitement de la stenose du canal rachidien lombaire

Country Status (3)

Country Link
US (1) US8403959B2 (fr)
EP (1) EP1824403A1 (fr)
WO (1) WO2006064356A1 (fr)

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