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WO2011007251A2 - Dispositif de stabilisation vertébrale - Google Patents

Dispositif de stabilisation vertébrale Download PDF

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Publication number
WO2011007251A2
WO2011007251A2 PCT/IB2010/001754 IB2010001754W WO2011007251A2 WO 2011007251 A2 WO2011007251 A2 WO 2011007251A2 IB 2010001754 W IB2010001754 W IB 2010001754W WO 2011007251 A2 WO2011007251 A2 WO 2011007251A2
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WO
WIPO (PCT)
Prior art keywords
end portions
stabilization device
spacer portion
vertebral
vertebral stabilization
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.)
Ceased
Application number
PCT/IB2010/001754
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English (en)
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WO2011007251A3 (fr
Inventor
Marco Ceccarelli
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2011007251A2 publication Critical patent/WO2011007251A2/fr
Publication of WO2011007251A3 publication Critical patent/WO2011007251A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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, e.g. 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
    • A61B17/7067—Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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, e.g. 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

Definitions

  • the present invention relates to a device for providing a vertebral stabilization that is adapted to treat various pain conditions and vertebral and disc diseases.
  • the device is adapted to treat foraminal stenosis, black disk, relapsed syndromes due to unsuccessful operations, spinal disc herniations, as well as the first phase of the lystesis.
  • vertebral stabilization is approached by two basic methodologies, i.e. a rigid stabilization approach, in which longitudinal elements are connected to adjacent vertebral bodies, and a stabilization by means of intervertebral spacers, which are arranged between adjacent spinous processes or between the laminae of two adjacent vertebrae.
  • spacers to be implanted between the spinous processes or between the laminae of the vertebral arches of two adjacent vertebrae leads to al less drastic spinal mobility reduction, in particular bending mobility is not much hindered; such spacer devices can be implanted by easier, and in most cases minimally invasive, procedures.
  • the above-mentioned devices are available in a plurality of sizes, which define the distance between the supports for the spinous apophyses. Therefore, the implantation of such devices requires selecting the size that is best suited for the patient to be treated, which in turn requires a measurement during operation, by a gauge or a phantom. Nevertheless, this measurement, due to practical difficulties, may be inaccurate and may lead to inappropriately select the device size, that need to be replaced causing discomfort to the patient and high cost to be sustained by the health care structure. At any rate, in the case of devices of fixed size, it is not possible to set a distraction width or force that is suitable for any patient. Such a drawback occurs both in the case of interspinous devices, as above mentioned, and in the case of interlaminar spacers.
  • interspinous type intervertebral devices results from the fact that the distraction force of a spacer between two adjacent vertebrae is applied at a rear peripheral point of each vertebra; therefore, under such a distraction force, the vertebrae tend to rotate with respect to each other about an axis that extends substantially along the coronal plane of the patient and is substantially normal to the spine. This may cause local kyphosis, as well as a compression of a front portion of the disc between the two adjacent vertebrae, since the vertebral bodies tend to approach at this portion, due to the relative rotation; accordingly, the disc is only partially relieved from the load acting upon it.
  • intervertebral devices consists of a low stability of the implant; in other words, the devices tend to be displaced from their implant sites, owing to the movement of the spine. Therefore, such devices are provided with additional stabilization means, i.e. further stabilization means in addition to the support surfaces which support the spinous processes or the laminae.
  • additional stabilization means i.e. further stabilization means in addition to the support surfaces which support the spinous processes or the laminae.
  • the interspinous spacer which is referred to in WO2007/034516 comprises fittings for fastening the device to the transverse processes
  • the interlaminar spacer which is referred to in WO/2005/044118 is provided with synthetic ligaments.
  • a drawback of such prior art interlaminar spacer is that it requires a deep implant between the laminae of the adjacent vertebral arches; the implant is difficult to apply, due to the low accessibility of the implant site, and to proximity to the spinal channel.
  • US 2006/0293662 discloses a prosthetic device for implantation in the vertebral column, the device comprising a body with a central support portion that laterally extends along a lateral axis between a first and a second end portion.
  • the first and the second end portions longitudinally extend along respective longitudinal axes generally perpendicular to the lateral axis; the end portions comprise an outer surface, and are dimensioned to be inserted between adjacent spinous processes such that when an end portion is inserted at least a portion of the outer surface engages at least one of the adjacent spinous processes.
  • the first portion and the second portion of the device have a respective screw-threaded connection, upon rotation of which the device can be longitudinally lengthened or shortened, in order to adjust the device between the spinous processes, once the implant has been inserted.
  • FR 2888744 describes a device to be implanted between the spinous apophyses to provide a distraction and a decompression of the disc; the device has a male portion and a female portion each adapted to be fastened to a spinous apophysis, and adapted to be fixed one to one another such that an articulated assembly is obtained in which the two portions can rotate or translate with respect to each other according to various directions.
  • US20060004447 discloses a height-adjustable device that is suitable for insertion between spinal processes that allows the surgeon to post-operatively adjust the height of the device once the device has been implanted.
  • US 2007100340 discloses a prosthetic device and a method for implanting it between two vertebrae of the vertebral column to stabilize the column, where the vertebrae engage with respective spacers that are movably connected with respect to each other, so that the distance between the spacers can vary according to the distance between the vertebrae in order to allow bending movements of the spinal column.
  • US 2009036925 describes a device for stabilizing two or more vertebral bodies with respect to one another, that comprises two fastening elements that are adapted to be associated with two adjacent vertebral bodies and a junction element that operatively connects the two fastening elements, wherein the union elements and the fastening elements gradually distribute the stresses on the pedicles and on the processes of the vertebral bodies in order to gradually and continuously load the column throughout all its length, thus preventing sudden changes of configuration in load and conformation in the borderline zones.
  • WO2009152156 discloses a prosthetic device for distracting spinal column segments in the lumbar and the lumbar-sacral regions, which comprises a first and a second engagement arms that are configured for receiving a lamina portion of the spinal column segment, a coupling mechanism and a locking mechanism.
  • the coupling mechanism is arranged between the first the second engagement arms and is configured to allow the device to turn from an unextended configuration to an extended configuration in order to distract the spinal column segment; the locking mechanism is configured for maintaining the extended configuration of the device.
  • a further limit of the prior art devices is their low adaptation to the shape of the spine of a scoliotic patient.
  • a feature of the present invention to provide such a vertebral stabilization device that can bear the load of all the portions of the intervertebral disc between two adjacent vertebrae.
  • a feature of the invention to provide an intervertebral device that is well suited for a scoliotic patient's spine morphologic and kinematical features.
  • a stabilization device for stabilizing two adjacent vertebrae of a patient's spine, each vertebra comprising a vertebral body from which, through pedicles, bone processes protrude among which a spinous process, said device adapted to be inserted into a space between two spinous processes of respective adjacent vertebrae, the stabilization device comprising:
  • the spacer portion is arranged between the end portions, such that the support surfaces are at a distance which corresponds to an extension of the spacer portion with respect to the end portions,
  • the device comprising an adjustment means for adjusting the extension of said spacer portion with respect to the end portions whereby said extension is brought to a predetermined value set between a minimum value and a maximum value, in order to provide an interspinous distraction of the two spinous processes between the support surfaces, the interspinous distraction corresponding to said predetermined value,
  • the vertebral stabilization device comprises at least one screw that is adapted to engage with the vertebral body of one of said vertebrae, and in that at least one of the two end portions comprises a guide element for the screw, the guide element and the screw adapted to push the vertebral body and to create by said adjustment means an intervertebral distraction between the vertebral body and an adjacent vertebral body, such that the predetermined value of the extension is achieved and the interspinous distraction is created, causing also a vertebral distraction responsive to the interspinous distraction.
  • the device offers a vertebral support that acts both posteriorly, as an interspinous support, which is located at a site behind the neutral axis of the vertebrae, and at the same time directly distracts the vertebral bodies, by means of the screw, which acts at a more front position by penetrating frontally as deep as possible into the vertebral bodies.
  • the degree of the distraction can be adjusted after introducing the prosthesis into the interspinous position and after implanting the screws, by extending the spacer portion.
  • the stabilization device comprises:
  • a further screw that is adapted to engage with the vertebral body of a first vertebra of the adjacent vertebrae, the screw and the further screw forming a first couple of screws;
  • the first and the second couple of screws adapted to create an intervertebral distraction between respective vertebral bodies of the first and of the second vertebrae, and to move the vertebral bodies away from each other according to a substantially translational movement.
  • the vertebral distraction involves the whole adjacent vertebral bodies, and no front portion of respective vertebral bodies approach to each other instead of moving away from each other, and the whole disc is at least partially relieved from loads that are transmitted between adjacent vertebrae.
  • the guide element, or each guide element is associated with a respective manoeuvre female screw member that is adapted to abut against a surface of the guide element or of each guide element, which in use faces the spine, such that, by tightening the manoeuvre element against the respective guide element, the screw engages with the vertebral body.
  • a stabilization device for two adjacent vertebrae of a patient's spine this device adapted to be inserted into a space between two spinous processes of respective adjacent vertebrae; the stabilization device comprises:
  • the spacer portion in use is arranged between the end portions, such that the support surfaces are at a distance which corresponds to an extension of the spacer portion with respect to the end portions;
  • the spacer device comprises an adjustment means for adjusting the extension of the spacer portion with respect to the end portions whereby said extension is brought to a predetermined value set between a minimum value and a maximum value, in order to provide a predetermined anatomic distance between the support surfaces, the predetermined anatomic distance corresponding to this predetermined value.
  • the adjustment means of the extension of the spacer portion comprises a screw-threaded means that in turn comprises:
  • a tool-engageable movable element the movable element having two screw-threaded end portions, the end portions respectively engageable with the left-hand external thread and with the right-hand external thread.
  • the device according to the invention may be manufactured as a one-size device, that is adapted for any size of distraction at the implant site, regardless of the spine morphology and other features such as patient's build and age, as well as of the spine position at which the implant must be made. This remarkably simplifies the production cycle of the device and makes it easier to supply it to the users.
  • the manoeuvre of the means for adjusting the extension of the spacer portion can be carried out also after that the device has been inserted between the spinous processes. This allows for an optimal adjustment of the distance between the support surfaces, without any preliminary measurement at the site where the device must be implanted.
  • the reliability of a measurement by a gauge is low, and often leads to select a too high or to a too low size of the device to be used, in which case the device must be replaced with a more suitable one, thus making the procedure less cost effective.
  • avoiding a gauging step makes the implant much less invasive than the methods in use, since both lateral and rear accesses are possible, in the latter case, after putting the supraspinous ligament aside.
  • the device according to the invention it is also possible to adjust the force that the adjacent vertebrae apply to each other. This way, a local mobility of the spine is allowed, without releasing the grip or losing the contact of the support surfaces with the spinous processes. This allows avoiding any additional stabilization means, thus remarkably simplifying the implant, since the operation can be carried out through a very small access.
  • the minimum value and maximum value of the extension of the spacer portion are selected such that the distance between the support surfaces is set between 6 and 16 mm, in particular between 8 and 14 mm.
  • the end portions and the spacer portion have a titanium, or titanium-alloy or a PEEK-based polymeric material outer surface
  • the movable element of the screw-threaded means is a nut that may be engaged and manoeuvred by means of a key tool, and the end portions of the device are adapted for a threaded engagement with respective screw-threaded portions of the nut.
  • the nut may be manoeuvred by means of a torque wrench, in such a way that a predetermined force is established between the spinous processes, said force depending upon the distraction degree, and upon the load that can be safely applied to the spinous processes, according to their strength, in particular to their flexural strength.
  • both end portions may be fixedly coupled with the spacer portion, in particular each end portion and one of the screw-threaded cylindrical bodies may form a single-piece element.
  • At least one of the end portions is articulated with the spacer portion, i.e. at least one of the end portions is constrained to the spacer portion but has a freedom of movement which is defined by a number of degrees of freedom. This way, the device may follow to the movement of the spine while maintaining its engagement with the spinous apophyses.
  • the at least one end portion is articulated with the spacer portion through a ball joint.
  • the at least one end portion is articulated with the spacer portion through a rotatable joint, said rotatable joint having a rotation axis that is transversal with respect to the longitudinal axis of the spacer device.
  • the at least one end portion is articulated with the spacer portion by a sliding joint along the longitudinal axis of the spacer device.
  • the end portion may be articulated with the spacer portion by a joint that is a combination of the above mentioned joints, or that allows a movement that corresponds to a combination of the relative movements of the above mentioned joints.
  • a resiliently compliant element is arranged between the articulated spacer end portion and the at least one end portion, such that a compression and/or a bending force that is applied by a spinous process on the end portions causes a resilient response of the device, the resilient response comprising a damping action between the support surfaces.
  • both end portions are articulated with the spacer portion through respective rotatable joints, the rotatable joints having respective axes that are transversal with respect to the longitudinal axis, the rotational axes arranged at a predetermined angle with respect to each other. In particular this angle is set between 75° and 105°; preferably the angle is a substantially right angle.
  • the device according to the invention allows an adjustment according to the two main movement directions, which is responsive to the local spine morphology; in particular it allows taking into account other permanent difference with respect to a normal spine, as in the case of scoliosis and hyperlordosis.
  • one of the end portions comprises a couple of support elements for respective laminae, the support elements adapted to provide respective support points for respective laminae of one of the adjacent vertebrae.
  • the support elements are adapted to provide respective support points for respective laminae of the upper vertebra.
  • the stabilization device may work both as an interlaminar spacer and an interspinous spacer.
  • the reaction forces which are received by the two vertebrae, can be located proximate to the centre of instant relative rotation between the two adjacent vertebrae, limiting the risk of kyphosis.
  • an interlaminar support is provided that does not need to be implanted deep between the spinous processes, where the prosthesis may achieve the interlaminar site, preventing any risk of contact with the spinal cord, which improves the safety of the implant.
  • At least one of the end portions comprises at least two extension wings, the two extension wings in use arranged substantially symmetrical with respect to a patient's sagittal plane, the two extension wings having a resiliently rotatable connection with a respective end portion of the two end portions, such that the two extension wings can cooperatively engage with one of the spinous processes, whereby, in use, the two extension wings are adapted to laterally contain the spinous processes.
  • the resiliently rotatable connection comprises a resilient hinge constraint.
  • the resiliency rotatable connection comprises a hinge constraint and a spring.
  • the resiliency rotatable connection comprises a combination of the above mentioned constraints.
  • a blocking means is provided for blocking the spacer portion at an extension that corresponds to the anatomic distance, in particular, the blocking means comprising the screw threads of the external thread, which are plastically compliant by compression.
  • FIG. 1 is a perspective view of a device according to an exemplary embodiment of the invention, in which the two end portions are fixedly coupled with the spacer portion;
  • FIG. 1 is an exploded perspective view of the device of Fig. 1 ;
  • FIG. 1' is a perspective view of a device according to another exemplary embodiment of the invention, in which the two end portions are fixedly coupled with the spacer portion;
  • FIG. 1 - figure 2' is a cross sectional view of the device of Fig. 1 ';
  • FIG. 1 is an exploded perspective view of the device of Figs. 1' and 2';
  • FIG. 4 is an exploded perspective view of a device according to a further exemplary embodiment of the invention, where the two end portions have support elements for laminae;
  • FIG. 5 is a perspective view of the device of Fig. 4;
  • FIG. 6 is a cross sectional view of the device of Figs. 4 and 5;
  • FIG. 6' is a perspective view of an end portion of a device, according to an exemplary embodiment of the invention, which has short tubular guide elements for screws;
  • - figure 6" is a perspective view of an end portion of a device, according to an exemplary embodiment of the invention, which has eyelet guide elements for screws;
  • - figure 7 is a perspective view of a device according to a first exemplary embodiment of the invention, where the two end portions are movably coupled with the spacer portion;
  • FIG. 8 is a cross sectional view of the device of Fig. 7;
  • figure 9 is an exploded perspective view of the device of Figs. 7 and 8;
  • figure 10 is a perspective view of an end portion of the device of Figs. 7, 8 and 9;
  • FIG. 11 is a perspective view of a cylindrical body that belongs to the spacer portion of the device shown in Figs. 7, 8 and 9;
  • FIG. 12 is a cross sectional view of a device according to yet another exemplary embodiment of the invention, where the two end portions are articulated with the spacer portion by a spherical coupling;
  • FIG. 12 is an exploded perspective view of the device of Fig. 12;
  • FIG. 14 is a perspective view of an end portion of the device of Figs. 12 and 13;
  • FIG. 15 is a perspective view of a cylindrical body that belongs to the spacer portion of the device of Figs. 12 and 13;
  • FIG. 16 is a diagrammatical cross sectional view of a first exemplary embodiment of the invention, which provides end portions that are resiliently rotatable with respect to the spacer portion;
  • figure 17 is a diagrammatical cross sectional view of a second exemplary embodiment of the invention, which provides end portions that are resiliently rotatable with respect to the spacer portion;
  • FIG. 18 is a cross sectional diagrammatical view of a plant of the device of Figs. 1 , 2 and 3;
  • FIG. 19 is a cross sectional diagrammatical view of a plant of the device of Figs. 4, 5 and 6;
  • FIG. 20 is an diagrammatical elevational side view of a plant of a device, according to the invention, which comprises screws that are adapted to engage with respective vertebral bodies of the patient's spine, the providing end portions like those shown in Fig. 6'.
  • a stabilization device 10' is described for two adjacent vertebrae 3,3' (Fig. 18), according to an exemplary embodiment of the invention, which has a vertebral distraction portion that is adapted to be introduced into a space 1 between spinous apophyses 2,2'.
  • the stabilization device comprises two end portions 11' that provide respective support surfaces 19 for each apophysis 2,2', and a spacer portion 13' between end portions 11'; spacer portion 13' has an extension L, which corresponds to a distance D between support surfaces 19.
  • the outer surfaces of both end portions 11' and spacer portion 13' are preferably made of titanium, or of another biocompatible material, such as PEEK.
  • spacer portion 13' comprises two cylindrical bodies 15' arranged aligned along an axis 18, which in use are arranged along the main direction of the patient's spine; in particular, cylindrical bodies 15' have respective oppositely directed inner threads 16", 16"', i.e. a right-hand one and a left-hand one, or vice-versa, which engage with a nut 17" that has two screw-threaded end zones 14", 14"' that are adapted to engage with thread 16" and with thread 16"', respectively.
  • An outer surface 17"' of nut 17 which can be manoeuvred by means of a key (not shown), in particular, by means of a torque wrench, allows adjusting the extension of spacer portion 13' and, therefore, a distance D of support surfaces 19, typically between a minimum value of 8 mm and a maximum value of 14 mm.
  • This manoeuvre may be carried out once the stabilization device 10 has already been arranged between spinous processes 2 (Fig. 18), to provide an anatomic distance D * between support surfaces 19.
  • end portions 11' are fixedly coupled with spacer portion 13'.
  • a stabilization device 10 is described for two adjacent vertebrae 3,3' (Fig. 18) according to another exemplary embodiment of the invention, which has a vertebral distraction portion that is adapted to fit a distance 1 between spinous apophyses 2,2'.
  • the stabilization device comprises two end portions 11 that provide respective support surfaces 19 for each apophysis 2,2', and a spacer portion 13 between end portions 11 ; spacer portion 13 has an extension L, which corresponds to a distance D between support surfaces 19.
  • the outer surfaces of both end portions 11 and spacer portion 13 are preferably made of titanium, or of another biocompatible material, such as PEEK.
  • spacer portion 13 comprises two cylindrical bodies 15 arranged aligned along an axis 18, which in use are arranged along the main direction of the patient's spine; cylindrical bodies 15' have respective oppositely directed inner threads 16, 16', i.e. a right-hand one and a left-hand one, or vice-versa, which engage with a nut 17 that has two screw-threaded zones that have a right-hand thread and with a left-hand thread, or vice-versa.
  • This manoeuvre may be carried out once the stabilization device 10 has already been arranged between spinous processes 2 (Fig. 18), to provide an anatomic distance D* between support surfaces 19.
  • end portions 11 ' are fixedly coupled with spacer portion 13.
  • a spacer/stabilizer device 20 is described for two adjacent vertebrae 3, 3' according to another aspect of the invention, wherein an end portion 21 is provided, which in use is arranged above, i.e. it is arranged as a support for the spinous apophysis 2 of an upper vertebra 3 (Fig. 19).
  • End portion 21 comprises a couple of support elements 22 for laminae 5, which provide respective support points 23.
  • the support between each support element 22 and laminae 5 is a bilateral type support owing to an upper extension 24 of support element 22.
  • the remainder parts of device 20 are similar to the corresponding parts of device 10, and are indicated by the same numeral.
  • both end portions 11 ,21 are fixedly coupled with spacer portion 13; in particular, each end portions 11 , 21 and one of the screw- threaded cylindrical bodies 15 form a single-piece element.
  • end portions 90 and 90' which pertain to the devices according to the invention, and comprise or are associated with screws 99 that are adapted to engage with respective vertebral bodies 4,4' of vertebrae 3 and 3', as shown in Fig. 20.
  • End portions 89 and 89' comprise guide elements 98 and 98', respectively, which in turn have the shape of short tubes or of eyelets, each adapted to receive a screw 99 for engaging with a vertebral body 4 or 4'.
  • the short tubes or eyelets may have a predetermined orientation to align respective screws 99 with a direction suitable for the screws to reach the vertebral bodies, in particular, through a transpedicular path.
  • short tubes 98 or eyelets 98' may be suitable for being oriented/adjusted according to the predetermined orientation.
  • the screw threads of screw 99 which may be conventional type screw threads or may be suitably designed at a determined length, engage with eyelets 987short tubes 98 in order to force screw 99 between short tubes/eyelets 98/98' and vertebral body 4/4'.
  • the load that is applied to the vertebral bodies may be unloaded on the device through the screws, according to the invention.
  • a predetermined distraction may be caused also on a position of the vertebral bodies that is substantially a front position, with respect to the neutral axis of the couple of vertebrae.
  • tulips fastening devices or "tulips” may be provided instead of the short tubes for adjustably anchoring the head of the screw; still in this case, a forcing means is advisable for forcing the screw within vertebral body 4/4' starting from the "tulip", for example by a tightening adjusting nut.
  • End portions 89 and 89' as shown in Figs. 6' and 6", comprise inner threads 16", 16"' such as end portions 11' of Figs. 1 and 2, but obviously may also comprise outer threads such as end portions 11 of Figs. 3, 4 and 5.
  • a stabilization device 30 is described for two adjacent vertebrae 3,3' (Fig. 18) according to a further aspect of the invention, wherein end portions 31 are provided that are articulated with a spacer portion 33.
  • end portions 31 have respective prismatic protrusions 36, that are fitted to a free end 36'.
  • Each protrusion 36 engages a prismatic seat 37 of a respective cylindrical body 35; this way, each end portion 31 can translate with respect to a respective cylindrical body 35, and therefore with respect to spacer portion 33 comprising two cylindrical bodies 35 and nut 17, along the direction of axis 18.
  • Each cylindrical body 35 has a through circular hole 39 that has an axis that is transversal with respect to axis 18; each hole 39, together with a through hole 40 of protrusion 36 of corresponding end portion 35, provides a pin seat.
  • each end portion 31 can rotate with respect to a cylindrical body 35, and then with respect to spacer portion 33, about axis 28 of pin seat of pin 38 and of hole 39.
  • Each hole 40 is bored such that it does not block the translation of respective ends portion 31 with respect to spacer portion 33, providing at the same time two end abutments 40' and 40" that limit this translation.
  • each end portion 31 is articulated with spacer portion 33 through a joint that is the combination of a sliding coupling 36-37 and of a rotatable joint 38-39-40.
  • a resiliently compliant ring 34 which is made of a biocompatible preferably silicone-based material, is arranged between an end surface 42 of each cylindrical body 35 and a shoulder 43 that surrounds the base of protrusion 36 of each end portion 35.
  • the ring 34 allows a resilient response of device 30 to compression and bending forces that are applied on the device by spinous apophysis 2, through support surfaces 19.
  • a stabilization device 50 is described for two adjacent vertebrae 3,3' (Fig. 18) according to another exemplary embodiment of the invention, where end portions 51 are articulated with a spacer portion 53 through a ball joint.
  • end portion 51 has a protrusion ball 56, which engages a ball seat 57 of a cylindrical body 55; this way, end portion 51 may rotate about a centre of rotation that is integral to cylindrical body 55, and therefore is integral with spacer portion 53 which comprises two cylindrical bodies 55 and nut 17.
  • a resiliently compliant ring 54 which preferably is made of a silicone-based biocompatible material, is arranged between an end surface 62 of each cylindrical body 55 and a ring surface 63 that surrounds the base of protrusion 56 of each end portion 51.
  • Ring 54 allows a resilient response of device 50 to compression and bending forces that are applied on the device by spinous apophyses 2,2', through support surfaces 19 (Fig. 18). This way, a local mobility of the spine is allowed, without releasing the grip or losing the contact of support surfaces 19 on spinous apophysis 2.
  • each ring 54 provides a friction coefficient between end portion 51 and cylindrical body 55, that is high enough to prevent a relative rotation of portions 51 and cylindrical bodies 55 when nut 17 is manoeuvred, end portions 51 engaging with spinous apophyses 3, 3'.
  • Threads 16, 16' which are opposite to each other, are plastically compliant under the action of a pliers, which is manoeuvred by an operator once devices stabilizer 10,20,30 has been implanted. This step is used for stabilizing anatomic distance D * between support surfaces 19, which has been obtained by manoeuvring nut 17.
  • end portions 71 , 81 comprises at least two extension wings 72 and 82, which, in use, are symmetrically arranged with respect to the patient's sagittal plane.
  • the two extension wings can be cooperatively engaged with one of the spinous processes (2),
  • extension wings (72,82) are selected from the group comprised of:
  • extension wing (72) that is pivotally connected to the spacer portion
  • Exemplary embodiments that differ from what described above may be obtained by combining end portions of different types, for example by combining end portion 11 ,11' or 21 , which is fixed with respect to the spacer portion, with end portion 31 or 51 , which is articulated with the spacer portion.
  • the spacer portion is in turn obtained by combining different type cylindrical bodies 15, 35, 55.
  • devices with an upper end portion that is articulated with the spacer portion, such as portions 31 and 51 , and which also comprise support elements for providing a support for the laminae, such as end portion 21 of device 20.
  • FIGs. 6', 6" and 20 reference is made to an intervertebral stabilizer/spacer device that has eyelets/short tubes for supporting screws for engaging with the vertebral bodies in combination with a lengthening of the spacer portion, this feature may be used even with the other exemplary embodiments that are shown in the other figures and are correspondingly described above.
  • the feature of providing support points for the laminae may be used even with the other exemplary embodiments that are shown in the other figures and are correspondingly described above.
  • the feature of the articulate end portions of Figs. 10-14 may be used even with the other exemplary embodiments that are shown in the other figures and are correspondingly described above.
  • the feature of the foldable or spring end portions of figures 16 and 17 may be used even with the other exemplary embodiments that are shown in the other figures and are correspondingly described above.

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  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif de stabilisation (10,20,30,50,90) pour deux vertèbres adjacentes (3, 3') conçu pour être inséré dans un espace (1) entre deux apophyses épineuses (2) de vertèbres adjacentes (3, 3') respectives. Le stabilisateur comprend une portion d'espacement allongée (13,33,53) qui s'étend le long d'un axe longitudinal (18); deux portions d'extrémité (11, 21 -21 ',31, 51) qui présentent des surfaces de maintien (19) respectives conçues pour maintenir chacune des deux apophyses épineuses (2). La portion d'espacement (13,33,53) est ménagée entre lesdites portions d'extrémité (11, 21 -21 ',31, 51), de telle sorte que lesdites surfaces de maintien (19) soient à une distance (D) correspondant à une extension (L) de ladite portion d'espacement (13,33,53) par rapport aux portions d'extrémité. Le dispositif comprend un moyen d'ajustement pour ajuster l'extension (L) entre une valeur minimum et une valeur maximum, afin d'obtenir entre les surfaces de maintien (19) une distance anatomique (D*) prédéterminée; le moyen d'ajustement pour ajuster l'extension comprend un filetage à gauche (15) et un filetage à droite (15') ménagés sur une portion respective desdites deux portions d'extrémités (11,21- 21',31, 51). En outre, le dispositif comprend un élément mobile capable de s'engrener dans un outil, lequel élément présente deux portions d'extrémité (17) filetées qui peuvent s'engrener respectivement avec le filetage à gauche et avec le filetage à droite, de telle sorte que lorsque l'élément mobile pivote, l'extension (L) de la portion d'espacement (13,33,53) augmente ou rétrécie, respectivement. Dans un mode de réalisation cité à titre d'exemple, les portions d'extrémité peuvent être articulées avec la portion d'espacement à l'aide d'un joint à rotule et/ou d'un joint coulissant et/ou d'un joint pivotant. Dans un mode de réalisation particulier cité à titre d'exemple, le dispositif comprend des supports pour les lames vertébrales.
PCT/IB2010/001754 2009-07-17 2010-07-19 Dispositif de stabilisation vertébrale Ceased WO2011007251A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITPI2009A000086 2009-07-17
ITPI2009A000086A IT1399785B1 (it) 2009-07-17 2009-07-17 Dispositivo distanziatore intervertebrale

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WO2011007251A2 true WO2011007251A2 (fr) 2011-01-20
WO2011007251A3 WO2011007251A3 (fr) 2011-05-12

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WO2013123497A1 (fr) 2012-02-17 2013-08-22 The Unversity Of Toledo Dispositif de fusion interépineuse postérieur multifonctionnel hybride
CN109464181A (zh) * 2018-12-20 2019-03-15 天衍医疗器材有限公司 枕颈固定装置

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EP1056408A1 (fr) 1998-02-20 2000-12-06 Jean Taylor Prothese inter-epineuse
WO2005044118A1 (fr) 2003-10-24 2005-05-19 Cousin Biotech, S.A.S. Support inter-lamaire
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013123497A1 (fr) 2012-02-17 2013-08-22 The Unversity Of Toledo Dispositif de fusion interépineuse postérieur multifonctionnel hybride
EP2814410A4 (fr) * 2012-02-17 2015-12-16 Univ Toledo Dispositif de fusion interépineuse postérieur multifonctionnel hybride
US10188434B2 (en) 2012-02-17 2019-01-29 The University Of Toledo Hybrid multifunctional posterior interspinous fusion device
EP3527155A1 (fr) 2012-02-17 2019-08-21 The University of Toledo Dispositif de fusion interépineuse postérieure multifonctionnelle hybride
CN109464181A (zh) * 2018-12-20 2019-03-15 天衍医疗器材有限公司 枕颈固定装置

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WO2011007251A3 (fr) 2011-05-12
ITPI20090086A1 (it) 2011-01-18

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