EP1802256A1 - Noyau de glissement coude pouvant faire partie d'une prothese de disque intervertebral destinee aux lombaires et aux cervicales - Google Patents

Noyau de glissement coude pouvant faire partie d'une prothese de disque intervertebral destinee aux lombaires et aux cervicales

Info

Publication number
EP1802256A1
EP1802256A1 EP05802723A EP05802723A EP1802256A1 EP 1802256 A1 EP1802256 A1 EP 1802256A1 EP 05802723 A EP05802723 A EP 05802723A EP 05802723 A EP05802723 A EP 05802723A EP 1802256 A1 EP1802256 A1 EP 1802256A1
Authority
EP
European Patent Office
Prior art keywords
sliding
core
intervertebral disc
partner
partners
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Withdrawn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
EP05802723A
Other languages
German (de)
English (en)
Inventor
Karin Büttner-Janz
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP1802256A1 publication Critical patent/EP1802256A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425Intervertebral or spinal discs, e.g. resilient made of articulated components
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/3008Properties of materials and coating materials radio-opaque, e.g. radio-opaque markers
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30383Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30505Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism spring biased
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30604Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30616Sets comprising a plurality of prosthetic parts of different sizes or orientations
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30621Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30649Ball-and-socket joints
    • A61F2002/30662Ball-and-socket joints with rotation-limiting means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30685Means for reducing or preventing the generation of wear particulates
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2310/00419Other metals
    • A61F2310/00544Coating made of tantalum or Ta-based alloys

Definitions

  • the invention relates to a sliding core and an intervertebral disc prosthesis for compensating angular positions between vertebral end plates, for functional maintenance or for improving the function of a movement segment of the lumbar and cervical spine.
  • Implants for replacement of the entire intervertebral disk are correspondingly bulky; they are introduced from the ventral or ventrolateral. An implantation immediately following a standard nucleotomy can not be performed with a prosthesis for complete intervertebral disc replacement.
  • the indication for function-preserving intervertebral disc replacement includes not only the primary painful discopathy but also operated patients with a so-called post-discomfort syndrome, patients who have a recurrent herniated disc in the same floor and Pati ⁇ ducks that have a connection surgery in a neighboring disc after a stiffening surgery.
  • a total of more than 10 different prostheses are currently being clinically used for the total replacement of disc braces.
  • Particularly well known in the lumbar spine are the Charite Artificial Disc, the Prodisc, the Maverick, the FlexiCore and the Mobidisc (overview in Clinica Reports, PJB Publications Ltd., June 2004) and in the cervical spine the Bryan prosthesis, the Prestige LP prosthesis , the Prodisc-C and the PCM prosthesis, which are described below.
  • the Prodisc prosthesis for the lumbar spine has been implanted since 1999 as a further development to Prodisc II. It is a 3-part but functionally 2-part intervertebral disc prosthesis in the metal-polyethylene sliding pair. Implantations with the Prodisc are performed in the lumbar spine and with an adapted prosthetic model, the Prodisc-C, also in the cervical spine. Different sizes, heights (over the polyethylene core) and lordosis angles (over the metal end plates) are available. The forward and backward inclination as well as right and left inclination are possible with the prosthesis in the same range of motion, the axial rotation is not limited in design.
  • the Prestige LP prosthesis has the possibility of an anterior-posterior translation, as a result of the horizontally anteriorly extended concavity, which has the same radius in the frontal section as the convexity.
  • the Maverick and the FlexiCore for the lumbar spine are functionally 2-piece prostheses with spherical convex-concave sliding partners, both in a metal-metal sliding pair.
  • the Mobidisc is a functional 3-part prosthesis in the metal-polyethylene pairing with 2 articulation areas.
  • the one area is as in the aforementioned three prostheses a section of a ball with one each convex and a concave surface of the articulating partners of the same radius and the other area of the Mobidisc is plan.
  • a braking of the axial rotation is provided in the plan area, however, this is not limited in the convex-concave articulation area.
  • the FlexiCore has a rotational limit within the spherical sliding surfaces over a narrow area of a stop.
  • the Bryan prosthesis As a compact prosthesis for the complete intervertebral disc replacement of the cervical spine, the Bryan prosthesis is in clinical use, which is fixed to the vertebral body via convex titanium plates with a porous surface and receives its biomechanical properties from a polyurethane nucleus.
  • the prosthesis is functionally 3-part in the sliding metal-polyethylene in 2 equal spherical Gleitflä ⁇ Chen, which has on the one hand, the transversely moving polyethylene core, and on the other hand, the correspondingly adapted concave pans in the two metal end plates.
  • different sizes of the metal plates of the Charite prosthesis and different heights of the size-adapted sliding cores and angled prosthesis end plates are available in the surface, which are implanted reversely in the sagittal direction and also as vertebral body replacement can serve.
  • the primary anchoring of the Charite prosthesis is done by 6 teeth, three of which are slightly offset to the middle, next to the front and back convex edges of each prosthetic plate.
  • the other prostheses have other primary anchors in the vertebral body-side metal plates, eg, a keel extending sagittally, a structured surface, a convex shape with, for example, transverse grooves and combinations thereof, even with differently located teeth.
  • you can Glands are used, either from ventral or internally in the intervertebral space into the vertebral body.
  • a main objective in the function-preserving intervertebral disc replacement is to largely adapt the movements of the prosthesis to the movement pattern of a healthy intervertebral disc.
  • Immediately related to this is the movement and stress in the vertebral arch joints, which have their own disease potential in the event of Albertbeanspru ⁇ chung.
  • the healthy intervertebral disc in cooperation with the other elements of the movement segment, is constructed in such a way that only certain movement circumferences are possible.
  • forward and backward movements of the trunk are combined with rotational movements in the intervertebral disc, and side movements combined with other movements are also carried out.
  • the movement excursion are, with respect to the extension (inclination) and flexion (anterior) and the lateral inclination to the right and left and also with respect to the rotation, very different in the case of a healthy intervertebral disk.
  • the prosthesis according to DE 35 29 761 C2 shows for this purpose a structure which distinguishes it from other available prosthesis types, which are constructed like a ball joint and consequently move only around a defined localized pivot point.
  • lumbar intervertebral discs Another important feature of healthy lumbar intervertebral discs is their trapezoidal shape, which is mainly responsible for lordosis of the lumbar and cervical spine.
  • the vertebral bodies themselves are only slightly involved in the lordosis.
  • the lordosis should be preserved or reconstructed as far as possible.
  • the Charite Disc Prosthesis there are four differently angled end plates, which can also be combined with each other.
  • DE 35 29 761 C2 discloses a slide core with a two-sided, partially spherical surface (lenticular), with a planar guide edge and externally provided with an annular bead. which jammed under extreme conditions between the two form-adapted end plates.
  • a similar intervertebral disc prosthesis is also known from DE 102 42 329 A1, which has a groove around the contact surfaces in which an elastic first ring in contact with the opposite contact surface is embedded for better guidance.
  • EP 0 560 141 B1 describes a 3-part intervertebral disc endoprosthesis, which likewise consists of two end plates and a prosthesis core located therebetween.
  • the intervertebral disc prosthesis described in this publication sets resistance to rotation on its end slats in opposite directions about a vertical vertical axis of rotation without stops on the prosthesis plates. This is achieved by sliding the end plates during rotation on the prosthesis core by the weight acting on the plates as a result of the biomechanical load transfer in the spinal column, since in the central sagittal and frontal section the respective curvature arcs differ from one another.
  • the above models are permanently anchored as implants in the disc space.
  • migration of the end plates into the vertebral bodies can occur in the medium to long term, resulting in dislocation of the entire implant, as a result of which artificial stresses on the vertebral bodies and the surrounding nerves and ultimately the entire movement segment can occur. associated with renewed complaints of the patient.
  • Also to be discussed are the long-term stability of the polyethylene and, if the polyethylene is not optimally loaded in the intervertebral space, the limited mobility of the intervertebral disc prosthesis. Insufficiently adapted ranges of motion and unfavorable biomechanical stresses in the movement segment can, under certain circumstances, lead to complaints persistence or later to patient complaints.
  • US Pat. No. 6,706,068 B2 describes an intervertebral disc prosthesis consisting of an upper and a lower part, wherein the parts are designed to correspond to one another, and no intermediate part is present as a middle sliding partner.
  • mutually articulating partners henceforli ⁇ che shapes are realized, so that it is a two-piece disc prosthesis.
  • this shaping is limited to structures which have neither edges and corners, so that in this way the two parts of the prosthesis articulate with each other; In this case, however, one can no longer speak of sliding partners. Or else two sliding partners are shown, in which one part is convex towards the inside of the prosthesis and the other sliding partner is correspondingly concave.
  • US 2004/093085 describes an implant for a vertebral body space, which has asymmetrical ends, which is adapted to the arcuate outer periphery of a natural disc, which is visible in a transverse section. This is intended to ensure that such an implant can cover a maximum area between the adjacent vertebral bodies, without protruding on the outer sides.
  • the ends of an implant according to US 2004/093085 can also be flattened so that they can reach into the periphery of the vertebral body space and be better inserted into the vertebral body space.
  • asymmetric prosthetic plates for example Charite Artificial Disc, Mobidisc
  • Oblique prosthesis plates are used for better adaptation to the anatomical and biomechanical conditions of the motion segment, especially in the lower lumbar spine, which is most severely affected by diseases.
  • the implantation of prostheses designed in this way can lead to an uneven pressure distribution in the sliding surfaces. This results in a higher material wear and limited mobility of the prosthesis as well as disadvantages for the vertebral arch joints (see above).
  • a sagittal section or a view in the sagittal plane allows a side view as the underlying sectional plane is perpendicular from front to back.
  • a “front” also “ventral” and for the indication “rear” analog “dorsal” is used, since this indicates the orientation of a prosthesis in the body.
  • a “frontal cut” or “frontal plane,” is a vertical cross-section from one side to the other side.
  • the term “lateral” also uses the term “lateral”. Both sagittal and frontal sections are vertical sections, as they run along a vertical plane, but are oriented 90 degrees apart.
  • a “transversal” or “transversal” view allows a view of the prosthesis as it is a horizontal incision.
  • an articulation surface is understood to be the region of sliding partners which consists of the curved convex, concave and planar parts of the surfaces which come into contact and slide with one another or against one another or articulate.
  • sliding surface is also used synonymously for articulation surface.
  • sliding core and middle sliding partner are synonymous with respect to a three-part intervertebral disc prosthesis.
  • the invention also expressly relates to sliding cores which, due to their connection without sliding surface with an upper or lower sliding partner, are in fact part of a two-part prosthesis, the side of the sliding cores opposite this connection being articulated with the second sliding partner.
  • a sliding core is provided which is arranged between the inner sides of an upper and lower sliding partner of a disc end prosthesis for equalizing angular positions between vertebral end plates, for function maintenance or for improving the function of a movement segment of the lumbar and cervical spine, characterized in that, depending on the configuration of a Convexity and / or concavity on the upper and / or underside of the slide core, one or two articulating sliding surface (s) between the slide core and inner side (s) of the upper and / or lower sliding partner arise and the Gleit ⁇ core is designed asymmetrically such that in at least one vertical cutting plane at least one sliding surface of the slide core is inclined at a defined angle to an imaginary horizontal.
  • the inclination of at least one sliding surface of the slide core to a horizontal is hereinafter also referred to as the angular position of the slide core.
  • An inventive Corresponding sliding core is thus not only asymmetrical in design, but at the same time purposefully angled.
  • a sliding core according to the invention is provided in the case of functionally two-part and three-part disc endoprostheses for compensating, correcting or maintaining angular asymmetries in a vertebral body gap.
  • a sliding core according to the invention can be selected and used in a targeted manner according to its asymmetric configuration from an existing range of different sized and differently high and differently angled sliding cores. Accordingly, a sliding core according to the invention can also be designed such that it can articulate or articulate with sliding partners of already existing intervertebral disc endoprostheses, but its use is indicated or advantageous on account of its asymmetry.
  • the angles occurring in the disc space between the adjacent vertebral end plates are between minus 10 degrees and plus 35 degrees, with negative degrees referring to a pathological kyphosis of the intervertebral space, the opposite of the physiological lordosis.
  • the superior side of the gliding membrane points anteriorly and dorsally at kyphosis.
  • the purpose of the operation is to produce with the sliding core according to the invention intraoperatively a position of the sliding partners to each other, which has only a minimum or no inclination of the sliding partners to each other as a prerequisite for postoperative physiological conditions coming close mobility in the disc space, so that the vertebral arch joints protected and the Nachbar ⁇ intervertebral discs are relieved.
  • the sliding core according to the invention thus has a key function.
  • the sliding core according to the invention relates overall to an angular range between 2 degrees and 35 degrees, wherein angular steps are provided in the sliding core in 2 degrees to 5 degrees of gradations.
  • a lordosis can be set by implantation of the sliding core according to the invention, or if it is attempted to at least reduce the kyphosis by means of a slightly angled sliding core, in which case the used one Sliding core has only a small, after dorsal open angle.
  • convexity and / or concavity extends over the entire top and / or bottom of the slide core or is each surrounded by an edge whose width and height are the same or different. Accordingly, according to the invention, both a sliding core with edge, as well as without edge provided.
  • an edge should be understood to mean a surface which is located between the outer edge of a slide core or sliding partner and the associated convexity or concavity (s).
  • the edges of the respective sliding partners extend horizontally and / or obliquely and preferably have a flat surface. It is essential for the design of the surface of the edges that, with a final inclination of the sliding partners to each other, to a gap as large as possible gap between the edges of the sliding comes. If the edges do not have a planar surface, they are in any case designed such that, in the case of a gap closure, the edges contact as extensively as possible.
  • a sliding surface suitable means for a permanently fixed, or fixed, but reversible connection with an o beren or lower sliding partner are provided on the opposite side.
  • the means for connection to a sliding partner or between sliding cores with a sliding surface designed on one side are, in particular, a narrowing or areal widening, possibly with the inclusion of the edge.
  • the shape of a Gleitkems invention is also adapted to the respective connection mechanism.
  • a groove / spring connection, a guide rail and corresponding recess, a snap mechanism, gluing or screwing are provided.
  • a sliding core In a sliding core according to the invention, provision is made for the entire sliding core or the articulating sliding surface (s) and, if the sliding surface (s) do not extend to the outer side (s), the edge and, if applicable, the Means for connecting Gleitpartnem - each consist of the same or different materials such as articulating sliding, or the same or different coated are like this.
  • an inventive sliding core for securing against slipping out of an intervertebral disc prosthesis at eridgradigem gap closure of the sliding partners, on the outside has a stop which is least on the top or bottom of the Gleitkems higher than the sliding core or its edge ,
  • the stop of a Gleitkems to protect against slipping out of an intervertebral disc prosthesis at endgradigem gap closure of the sliding, wel ⁇ Chen the slide core on top and bottom, according to the invention may also be designed such that it is equal to or higher than the slide core or its edge and Within a groove from the edge region of the upper and / or lower sliding partner with the necessary play for the maximum sliding movement of the sliding partner is performed.
  • a sliding core with edge in a further embodiment, it is provided that the height of the edge increases in part or in total continuously from the transition region between the convexity and the edge to the outer edge region, without the size of the opening angle due to adaptation of the edge height of an upper and lower sliding partner of a three-piece disc endoprosthesis.
  • This "dovetail shape" from the edge of the slide core increases its security against a dislocation.
  • An inventive sliding core has a sliding surface of plan, spherical, cylindrical, ellipsoidal, spindle-shaped, oval or asymmetrical surfaces or combinations thereof, which are suitable for sliding movement, wherein in a sliding core with sliding surfaces on the top and bottom of the respective sliding surfaces identical or designed differently with respect to shape, height and / or direction of the sliding movement enabled.
  • spindle-shaped means a form which is based on the shape of an "American Football". Due to the flexible design of the shaping of the articulating surfaces of a sliding core according to the invention, its adaptation to the configuration of concaves and / or convexities of existing sliding partners, which are connected to a vertebral body, is made possible.
  • the invention asymmetrically designed, angled sliding core can also be adapted to the articulation surfaces of existing prostheses. This opens up the possibility of providing sliding cores for different types of prosthesis and of considering existing asymmetries in the respective vertebral body space by designing non-parallel sliding surfaces or of deliberately “adjusting" the movement to protect the vertebral implant border and, in particular, the vertebral arch joints.
  • a further subject of the invention is an intervertebral disc endoprosthesis for compensating angular positions between vertebral end plates, for functional preserving or improving the function of a movement segment of the lumbar and cervical spine, consisting of an upper sliding partner with an upper outside, which means for firm connection with an upper vertebral body, and a lower sliding partner with a lower outside, which means for fixed connection to a lower Vertebral body, wherein between the inner sides of the upper and lower sliding partner a sliding core angeord ⁇ net is, characterized in that depending on the configuration of a Kon ⁇ vexmaschine and / or concavity on top and / or bottom, one or two artikulie ⁇ Sliding surface (s) between the slide core and inner side (s) of the upper and / or lower sliding partner arise, and the sliding core is designed asymmetrically angled so that in at least one vertical cutting plane at least one sliding surface of the slide core at an angle to a imaginary Horizonta ⁇ len is inclined.
  • a functionally two-part or three-part intervertebral disc prosthesis with an asymmetrical angled sliding core is provided.
  • Upper and lower sliding partners of a three-part prosthesis and the two sliding partners of a two-part prosthesis act simultaneously as end plates, which have means which serve for connection to an upper or lower vertebral body.
  • the angles occurring in the disc space between the adjacent vertebral end plates are between minus 10 degrees and plus 35 degrees, with negative degrees referring to a pathological kyphosis of the intervertebral space, the opposite of the physiological lordosis.
  • the higher side of the gliding nucleus points anteriorly and dorsally at kyphosis.
  • the operation goal is to provide intraoperatively with the intervertebral disc prosthesis according to the invention a position of the sliding partners to each other, the only a minimal or no inclination of the sliding partners to each other as Vor ⁇ suspension for a postoperative physiological conditions close coming de mobility in the disc space so that the vertebral arch joints are spared and the neighboring discs are relieved.
  • the movement excursion into the different directions of movement is optimally possible postoperatively.
  • the slide core within the disc endoprosthesis as a whole refers to an angle range between 2 degrees and 35 degrees, wherein angular steps are provided in the slide core in 2 degrees to 5 degrees increments.
  • a lordosis can be adjusted in the most favorable case via the implantation of the intervertebral disc prosthesis according to the invention, or if an attempt is made to at least reduce the kyphosis by means of a only slightly angled sliding core, in which case the inserted one Gleit ⁇ core has only a small, dorsally open angle.
  • the intervertebral disc prostheses according to the invention offer the possibility of obtaining or compensating for a patient-specific scoliosis in the surgical segment without causing disadvantages in the extent of movement of the prosthesis or loading of the vertebral arch joints.
  • the intervertebral space can be widened scoliotic asymptomatic due to the intervention prior to insertion of the prosthesis plates.
  • an intervertebral disc prosthesis according to the invention with an asymmetrically angled sliding core it is possible to adapt the sliding surfaces to this asymmetry. Thereby the patient is facilitated an optimal movement in the movement segment affected by the operation, as e.g.
  • the articulation surfaces of the upper and lower sliding partners are each enclosed by an edge of the same or different width and height, whereas the articulation surfaces of the sliding core of a three-part prosthesis are in each case extend over the entire top and bottom, so are edge-free, or the arti ⁇ kulations vom are each surrounded by an edge whose width and height are the same or different.
  • an edge is particularly advantageous if, in the case of end-grade inclination, it is involved in a gap closure, since in this way the pressure bearing on a movement segment is distributed over a larger surface. This further preservation of the material of the prosthesis parts or the coatings of the surfaces is achieved.
  • an edge, which surrounds the corresponding articulation surfaces also contribute to the adjustment of the inclination.
  • the asymmetrically angled sliding core and the sliding partners are each integrally formed or the sliding partners and / or the asymmetrically angled sliding core each consist of at least two fixed or fixed but reversibly interconnected parts, or asymmetrically angled sliding core fixed, or fixed, but reversibly connected to one of the sliding, wherein the korrespondieren ⁇ the articulating surfaces opposite side means for a solid or solid, over reversible compound and sliding partner and / or the sliding core and each connected thereto Parts made of the same or different materials or the surfaces are coated the same or different.
  • Suitable means for a compound according to the invention are adaptations of the shape of the interconnected parts or e.g. the convexity or e.g. Konka ⁇ vity opposite side, such as areal widenings that are part of the edge or the entire edge, or recesses, provided.
  • the respective sliding partner and / or e.g. Convexity and / or e.g. Kon ⁇ concavity and the edge provided.
  • a middle sliding partner it is additionally provided that this first arises from the connection of the respective parts.
  • an intervertebral disc prosthesis according to the invention consists of fixed or fixed, but reversibly interconnected parts, is for the connection between
  • Gleitpartner and eg convexities) or eg concavity (s) preferably one Tongue / groove connection, a guide rail and corresponding recess, a snap mechanism, gluing or screwing provided.
  • the asymmetrically angled sliding core and the sliding partners consist of the same or different materials or the surfaces are coated identically or differently, but also that the asymmetrically angled sliding core consists of several or a material), on the one hand depending on whether different functional areas, such as, for example, the edge or middle part, are designed for a connection, or, on the other hand, on the material of the articulating sliding partners.
  • the sliding partners of an intervertebral disc prosthesis according to the invention and also of a sliding core according to the invention are manufactured from proven materials in implant technology; For example, consist of the upper and lower sliding stainless steel and the middle sliding partner of medical polyethylene. Other material combinations are conceivable. The use of other alloplastic materials, which may also be bioactive or blunt, is also conceivable.
  • the sliding partners are highly polished at the mutually facing contact surfaces in order to minimize abrasion (Iow-friction principle).
  • a coating of the individual sliding partners is provided with suitable materials.
  • the following materials are preferably provided: titanium, titanium alloys or titanium carbide, alloys of cobalt and chromium or other suitable metals, tantalum or suitable tantalum compounds, suitable ceramic materials and suitable plastics or composite materials.
  • the sliding surface can consist of planar, spherical, cylindrical, ellipsoidal, spindle-shaped or oval surfaces or combinations thereof which allow a sliding movement with the articulating sliding partner and in the case of a sliding core with sliding surfaces on top and bottom Sliding surfaces are designed identically or differently with regard to shape and / or direction of the sliding movement made possible.
  • a maximum opening angle with one-sided gap closure of the sliding partners is provided for extension or flexion between 6 and 10 degrees and for lateral gap closure between 3 and 6 degrees.
  • the convexity (s) and associated corresponding concavity (s) are offset by up to 4 mm from the central frontal section.
  • Such a dorsally offset center of rotation corresponds to the physiological situation in the transition between the lumbar spine and the sacrum, whereby a further approximation to the physiological situation is achieved by an intervertebral disc prosthesis according to the invention.
  • edges of the sliding partners are outright at right angles, otherwise angled, curved or combined straight, curved and / or finished at an angle.
  • a prosthesis is conceivable in such a embodiment, in which upper and lower side of the middle slide core in the outer edge region simply cut off at right angles or in a curved manner and the edge width is not configured substantially differently than in the case of upper and lower slide partners.
  • the sliding core will still remain between the upper and lower sliding partners, and this makes possible a very compact and space-saving design of an intervertebral disc endoprosthesis according to the invention.
  • a stop part of the edge of the middle sliding partner resp. Sliding core is disposed outside of the upper and / or lower sliding partner, wherein the stopper is at least on the upper or lower side higher than the edge of the middle sliding partner.
  • This stop for additional protection against sliding out, slipping or slipping out (dislocation) can also be designed according to the invention such that the stopper is part of the edge of the slide core, which is higher than the edge of the slide core on the top and / or bottom is guided within a groove from the edge region of the upper and / or lower sliding partner with the necessary clearance for the maximum sliding movement of the sliding partner.
  • an outward continuation of the edge of a middle Gleitpartners resp. Sliding core can be understood, which is suitable due to the particular configuration, to prevent slipping out of the middle sliding partner from the concavities of the upper and lower sliding partner.
  • a stop must not completely enclose the middle sliding partner, as this can lead to restrictions on the maximum mobility of all sliding partners, but may be arranged at defined intervals or opposite to positions of the edge, which are suitable for slipping out of the middle sliding partner in question.
  • the stop on the top and bottom is higher than the edge of the middle sliding partner, it can be designed, for example, like a tack, which has been inserted with the needle tip from the outside into the edge of the middle sliding partner, so that the head of the Tacking projecting above and beyond the edge of the middle sliding partner and at a final inclination to the position of the tack prevents the sliding out of the middle sliding partner by "striking" the upper and lower sliding partner.
  • the height of the convexity is merely dependent on the desired maximum tilting angle on which this also has an influence (see above).
  • a stop for securing the slide core in the case of a three-part prosthesis is advantageously designed in such a way that it also participates in the gap closure of the rim in the event of a final inclination of the sliding partners.
  • the stopper not only does the stopper have a securing function, but it also serves to increase the areas subjected to pressure in the case of the end-grade inclination of the sliding partners, thereby sparing the prosthesis material.
  • the possibility of such a configuration depends decisively on the outer shape and the respective edge width of convexity and concavity of the upper and lower sliding part ners.
  • a three-part intervertebral disc prosthesis is provided that the height of the edge of the middle sliding partner resp. Sliding core from the transition region between the convexity and the edge to the outer ren edge area partially or continuously increases continuously, without changing the size of the opening angle due to adjustment of the edge height of the upper and lower sliding partner.
  • This "dovetail shape" from the edge of the middle sliding partner increases its security against a dislocation.
  • a form of upper and / or lower sliding partner in which the outer edge regions are fully or partially hook-shaped, rectangular, otherwise angled, curved or in combinations thereof in the direction of the other outer sliding partner.
  • the edge of the middle sliding partner is narrower there in this embodiment, so that the middle sliding partner is partially or completely bordered by the Vorrich ⁇ lines of one or both outer sliding to prevent slipping out of the middle slider.
  • the edge of the middle sliding partner is adapted to the edge shape of an outer sliding partner in such a way that the largest possible surface of the articulating sliding partner comes into contact with a final gap closing.
  • the outer circumference of the upper and lower sliding partner can taper in a transversal view from dorsal to ventral (lumbar spine) or from anterior to dorsal (cervical spine).
  • This tapering of the outer circumference of the upper and lower sliding partner can be formed laterally in each case as identical curvature and is preferably a partial section of a circle.
  • the surface and shape of the outer periphery of the upper and lower sliding partner can be the same or different as needed and so adapted to the particular size of the vertebral body to which they are connected.
  • the tapered shape of the outer circumference of the upper and lower Gleit ⁇ partners are formed as identical curvatures and correspond wesentli chen the useable for the prosthesis plates surface of a vertebral body in the transverse view and thus lead to an optimal use of the available surface of a vertebral body Anchoring of the sliding partners with the aim of the largest possible load transfer of auflie ⁇ on the sliding partners lowing pressure. Furthermore, in an intervertebral disc prosthesis according to the invention, sliding partner adaptations are provided, wherein upper and / or lower sliding partners are formed in the frontal and / or sagittal section in such a way that the outer and inner sides of the upper and / or lower sliding partner are parallel or not parallel to one another run.
  • an intervertebral disc endoprosthesis according to the invention can additionally be adapted to vertebral end plates which are not parallel to one another in a front view or should form an optimal lordosis and sliding surface position relative to one another in the sagittal view.
  • the adaptation to existing asymmetries is accomplished not only by the angled slide core, but also by upper and lower sliding partners, in particular in the case of particularly pronounced asymmetries in the intervertebral space.
  • the slide core compensates for asymmetry in one direction and that the plates compensate for asymmetry in another direction.
  • marginal and / or planar toothing of the outer sides of the upper and lower sliding surfaces is used for connection to an upper or lower vertebral body.
  • the outer sides themselves are flat or convex in shape and it is possible to coat the toothing or the entire outer side, even without toothing, in a bioactive or blunt manner.
  • an anchoring is required three ventral arranged and two dorsally arranged anchoring teeth prefers.
  • continuous lateral rows of teeth are advantageous for better guidance of the upper and lower sliding partners when inserting between the vertebral bodies, since the working forceps of the surgeon between the middle gap between see the rows of teeth or at the height of the teeth in guide holes of the upper and / or lower sliding partner.
  • the upper and lower sliding partners have, in another embodiment, provisions for instruments. These provisions preferably consist of holes or formations into which the respectively required instrument of the surgeon can intervene and thus a secure hold of the respective sliding partner is made possible.
  • a maximum width (front view) of 14 to 48 mm, a maximum depth (sagittal section) of 11 to 35 mm and a maximum height of 4 to 18 mm are provided as absolute measures. These dimensions are based on the natural conditions and thus ensure that an intervertebral disc endoprosthesis according to the invention comes as close as possible to the in vivo situation.
  • one or more X-ray-contrasting markings are provided which do not contain any X-ray-contrasting parts of the prosthesis below their respective surface. This makes it possible to control the position of these parts of an intervertebral disc endoprosthesis directly after implantation to an exact location. Furthermore, it is possible to check at defined time intervals by X-ray whether these parts of the prosthesis have changed their position or are still precisely positioned.
  • FIG. 1 Schematic transverse view of a sliding partner with concavity
  • FIG. 6a-c Schematic representation of various shapes of the upper and lower sliding partner of the lumbar spine
  • Figure 1 shows a plan view of the inside of a sliding partner 11, 12 with a concavity 17, which is enclosed by the edge 14.
  • the shape of the concavity 17 corresponds to a hollow spherical recess.
  • the shape of the taper is circular, but other shapes are also conceivable.
  • Figures 6 a - c show more Forms of the outer shape of an upper and lower sliding partner 11, 12 ersicht ⁇ Lich.
  • FIGS. 2 a - c show a schematic view of a central frontal section of a two-part intervertebral disc prosthesis according to the invention with angled sliding core 13 and upper and lower sliding partner 11, 12.
  • lower sliding partner 12 and angled sliding core 13 can be integrally, firmly or firmly, but reversibly connected to each other.
  • FIGS. 2 a - c show the laterolateral angular position of the edge 14 and the convexity 16 of the angled sliding core 13.
  • the convexity 16 articulates with the concavity 17 of the upper sliding partner 11.
  • the entire surface, consisting of edge 14 and convexity 16 of the angled sliding core 13, is laterolaterally inclined with respect to a horizontal and has a defined angle to the horizontal.
  • the surface of the edges 14 on both sides of the convexity 16 lie on a common line.
  • the convexity and the corresponding concavity may be symmetric or asymmetric in connection with the inclination.
  • FIG. 2 a shows the inclined outer side of the upper sliding partner 11, which is not due to an inclination of the upper sliding partner 11 to one side of the edge 14 of the asymmetrical sliding core 13, but is due to the laterolateral inclination of the angled sliding core 13.
  • the gaps between the edge 14 of the angled sliding core 13 and the edge 14 of the upper sliding partner 11 are equally large on both sides of the convexity 16 and the concavity 17.
  • FIG. 2 b shows a gap closure between the edges 14 on the left side of convexity 16 and concavity 17 of the upper and lower sliding partners 11, 12 and 13, whereas FIG. 2 c shows a one-sided gap closure on the right side of convexity 16 and 13 Concave 17 shows.
  • FIGS. 3 a - c each show a central sagittal section of a two-part intervertebral disc prosthesis according to the invention with angled slide core 13 and upper and lower sliding partners 11, 12.
  • the edges 14 and the convexity 16 of the angled sliding core 13 have an inclination of dorsal in these three figures in anterior or ventral to dorsal with respect to a horizontal.
  • This inclination of the angled slide core 13 is the cause of the inclination of the outer slide.
  • te of the upper sliding partner 11, which articulates on the concavity 17 with the angled sliding core 13, without the upper sliding partner 11 would be inclined to the edge 14 of the a-symmetrical Gleitkems 13.
  • FIGS. 4 a - c show a schematic view of a central frontal section of a three-part intervertebral disc prosthesis according to the invention with angled slide core 13 and upper and lower sliding partners 11, 12.
  • the angled sliding core 13 has a sliding surface with a convexity 16 and an edge 14 on the upper and lower sides. With respect to a horizontal both edges 14 are inclined, wherein the edges 14 of a sliding surface each lie on a common Ge raden, but can not lie on any common line. Overall, when viewing the edge 14 of the upper and lower sliding surface of the angled sliding core 13 thus results in a wedge shape.
  • the convexities 16 of the upper and lower sliding surfaces articulate in each case with the concavity 17 of the upper or lower sliding partner 11, 12.
  • convexities and the corresponding concaves can be symmetrical and asymmetrical in connection with the angulation.
  • the entire surface of a sliding surface, consisting of edge 14 and convexity 16 of the asymmetrical slide core 13, is laterally inclined with respect to a horizontal and has a defined angle to the horizontal. This angle can be the same or different in relation to the horizontal top and bottom.
  • the shape of the convexity 16 corresponds to a spherical cap and the thus articulating concavity 17 on the inside of an upper or lower sliding partner 11, 12 of a hollow sphere, which is shown in Figure 1.
  • FIG. 4 a shows a three-part prosthesis in which the upper and lower sliding partners 11, 12 are not inclined to one side of the angled sliding core 13. On both sides of convexity 16 and concavity 17, an equally large gap with an identical opening angle is visible on both the upper and the lower sliding surface.
  • Figure 4 b are upper and lower sliding partner 11, 12 to the left Edge 14 of the angled sliding core 13 is inclined, whereby it comes in the illustrated embodiment to a gap closure on the left of the convexities 16 and 17 Konkavitä ⁇ .
  • FIG. 4c shows a gap closure of the edges 14 on the right of the convexities 16 and concavities 17.
  • FIGS. 5 a - c each show a central sagittal section of a three-part intervertebral disc prosthesis according to the invention with angled slide core 13 and upper and lower sliding partners 11, 12.
  • the edges 14 and the convexities 16 of the angled slide core 13 point in the top and bottom in these three Figu ⁇ ren an inclination of dorsal to ventral or from ventral to dorsal with respect to a horizontal.
  • This inclination of the angled slide core 13 is the cause of the inclination of the outer sides of the upper and lower sliding partners 11, 12, which each articulate via the concaves 17 with the convexities 16 of the angled Gleit ⁇ core 13, without upper and / or lower Gleitpartners 11, 12 would be inclined to the edge 14 of the angled Gleitkems 13.
  • Such a tendency of the upper sliding partner to the dorsal or ventral edge 14 of the angled Gleit ⁇ core 13 is shown in Figures 5 b and c.
  • FIGS. 6 a - c show in a plan view on upper and lower sliding partners 11, 12 schematically alternative configurations of the shape of the outer periphery.
  • FIGS. 7 a and 7 b alternative arrangements of anchoring teeth 21 on the outside of the upper and lower sliding partners 11, 12 are shown for the lumbar spine.
  • no anchoring tooth 21 is provided in the middle, since on the one hand this protects the vertebral bodies and on the other hand facilitates implantation.
  • the opposite orientation applies again to the cervical spine, again without a central dorsal anchoring tooth 21.
  • the embodiments of the intervertebral disc prosthesis according to the invention shown in the figures, both in a two-part and in a three-part embodiment, are only examples and not exhaustive.
  • the angled Gleit ⁇ core 13 is also the subject of independent claim 1 and thus is not only in connection with a two- or three-piece intervertebral disc prosthesis.
  • the convexity or concavity of an angled sliding core 13 according to the invention can be chosen or dimensioned such that the angled sliding core 13 is compatible with other prostheses. This makes it possible to use a erfindungs ⁇ contemporary angled Gleitkem in a primary or revision surgery in exchange for the slide core of the existing prosthesis. This eliminates the need to well-healed sliding partners, which are associated with vertebral bodies, also eliminated.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un noyau de glissement et une prothèse de disque intervertébral destinés à compenser des positions angulaires entre des plaques vertébrales terminales et à conserver ou améliorer la fonction d'un élément mobile des lombaires ou des cervicales. Le noyau de glissement selon l'invention, employé dans des prothèses de disque intervertébral en deux ou trois parties, est destiné à compenser, conserver ou améliorer des positions angulaires dans un espace vertébral intermédiaire. Ledit noyau de glissement permet par ailleurs de conserver l'ancrage de plaques prothétiques implantées dans les vertèbres. L'invention concerne également des prothèses de disque intervertébral en deux ou trois parties comportant un noyau de glissement coudé de façon asymétrique. Les éléments de glissement inférieur et supérieur d'une prothèse en deux ou trois parties agissent en tant que plaques terminales présentant des éléments servant à la connexion à une vertèbre supérieure ou inférieure.
EP05802723A 2004-10-18 2005-10-18 Noyau de glissement coude pouvant faire partie d'une prothese de disque intervertebral destinee aux lombaires et aux cervicales Withdrawn EP1802256A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/DE2004/002330 WO2006042484A1 (fr) 2004-10-18 2004-10-18 Noyau de glissement coude constituant une partie d'une endoprothese de disque intervertebral
PCT/DE2005/001883 WO2006042531A1 (fr) 2004-10-18 2005-10-18 Noyau de glissement coude pouvant faire partie d'une prothese de disque intervertebral destinee aux lombaires et aux cervicales

Publications (1)

Publication Number Publication Date
EP1802256A1 true EP1802256A1 (fr) 2007-07-04

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EP05802723A Withdrawn EP1802256A1 (fr) 2004-10-18 2005-10-18 Noyau de glissement coude pouvant faire partie d'une prothese de disque intervertebral destinee aux lombaires et aux cervicales

Country Status (8)

Country Link
US (1) US20060235528A1 (fr)
EP (1) EP1802256A1 (fr)
JP (1) JP2008516646A (fr)
CN (1) CN101065081A (fr)
AU (1) AU2005297474A1 (fr)
CA (1) CA2582241A1 (fr)
DE (5) DE112005003253A5 (fr)
WO (2) WO2006042484A1 (fr)

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Also Published As

Publication number Publication date
AU2005297474A1 (en) 2006-04-27
CN101065081A (zh) 2007-10-31
WO2006042484A1 (fr) 2006-04-27
DE112005003257A5 (de) 2007-09-20
DE502005010942D1 (de) 2011-03-17
CA2582241A1 (fr) 2006-04-27
DE112005003256A5 (de) 2007-09-20
US20060235528A1 (en) 2006-10-19
JP2008516646A (ja) 2008-05-22
DE112005003255A5 (de) 2007-09-20
DE112005003253A5 (de) 2007-09-20
WO2006042531A1 (fr) 2006-04-27

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