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Artificial functional spinal unit assemblies

a functional and spinal unit technology, applied in the field of functional spinal implant assemblies, can solve the problems of spinal pathologies, reducing the height of the disc nucleus, and reducing the mobility of the anulus, and achieve the effect of reducing mobility

Inactive Publication Date: 2006-08-31
FLEXUSPINE INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0018] Since a properly functioning natural FSU relies on intact posterior elements (facet joints) and since it is necessary to remove these elements to place a posterior interbody device, a two-step procedure is disclosed that allows for placement of an expandable intervertebral implant and replacement of one or both facets that are necessarily removed during the surgical procedure. The expansile nature of the disclosed devices allow for restoration of disc height once inside the vertebral interspace. The expandable devices are collapsed prior to placement and then expanded once properly inserted in the intervertebral space. During the process of expansion, the endplates of the natural intervertebral disc, which essentially remain intact after removal or partial removal of the remaining natural disc elements, are compressed against the device, which thereby facilitates bony end growth onto the surface of the artificial implant. Once the interbody device is in place and expanded, the posterior element is reconstructed with the disclosed pedicle screw and rod system, which can also be used to distract the disk space while inserting the artificial implant. Once the interbody device is in place and expanded, the posterior element is further compressed, again promoting bony end growth into the artificial implant. This posterior compression allows for anterior flexion but replaces the limiting element of the facet and interspinous ligament and thereby limits flexion to some degree, and in doing so maintains stability for the anteriorly located interbody device.
[0019] The posterior approach avoids the potential risks and morbidity of the anterior approach, which requires mobilization of the vascular structures, the ureter, and exposes the bowels to risk. Also, the anterior approach does not offer the surgeon an opportunity to view the posterior neural elements and thereby does not afford an opportunity for decompression of those elements. Once an anterior exposure had been utilized a revision procedure is quite risky and carries significant morbidity.
[0020] The artificial FSU generally comprises an expandable intervertebral implant and one or more artificial facet joints. The expandable intervertebral implant generally comprises a pair of spaced apart plate members, each with a vertebral body contact surface. The general shape of the plate members may be round, square, rectangular, banana shaped, kidney shaped, or some other similar shape, depending on the desired vertebral implantation site. Because the artificial intervertebral implant is to be positioned between the facing surfaces of adjacent vertebral bodies, the plate members are arranged in a substantially parallel planar alignment (or slightly offset relative to one another in accordance with proper lordotic angulation) with the vertebral body contact surfaces facing away from one another. The plate members are to mate with the vertebral bodies so as to not rotate relative thereto, but rather to permit the spinal segments to axially compress and bend relative to one another in manners that mimic the natural motion of the spinal segment. This natural motion is permitted by the performance of an expandable joint insert, which is disposed between the plate members. The securing of the plate members to the vertebral bone is achieved through the use of a osteoconductive scaffolding machined into the exterior surface of each plate member. Alternatively, a mesh of osteoconductive surface may be secured to the exterior surface of the plate members by methods known in the art. The osteoconductive scaffolding provides a surface through which bone may ultimately grow. If an osteoconductive mesh is employed, it may be constructed of any biocompatible material, both metal and non-metal. Each plate member may also comprise a porous coating (which may be a sprayed deposition layer, or an adhesive applied beaded metal layer, or other suitable porous coatings known in the art, i.e. hydroxy appetite). The porous coating permits the long-term ingrowth of vertebral bone into the plate member, thus permanently securing the prosthesis within the intervertebral space.
[0023] In addition, another embodiment of the artificial facet joint is disclosed that generally comprises two locked pedicle screws joined by a rod having a ball and socket joint centrally located on the rod between the two pedicle screws. The locking of the pedicle screws prevents the screw head from swiveling, but allows rotation and translation of the rod.
[0024] In instances where a fusion procedure is unavoidable, a PLIF and TLIF cage are disclosed that utilize the expansion principal of the functional artificial intervertebral implant. The cage generally comprises three parts: An external body, an internal body, and an expansion device. The external and internal bodies will have substantially the same shape and will be shaped accordingly to the procedures for which they will be used, more specifically, a rectangular cage is employed for a PLIF procedure and round or banana shaped cage is employed for the TLIF procedure. Both the external and internal bodies comprise a mesh structure in which an osteoconductive substance can be placed (i.e. morsilized autograph or an osteobiologic substitute). The external body of the cage contains an internal void space that houses the internal body. The external body further comprises an expansion window on its superior surface through which the internal body is raised upon expansion of the cage. The internal body comprises a planar plate member that is slightly larger than the expansion window in the superior surface of the external body such that when the cage is expanded the planar plate member secures itself against the interior side of the expansion window, thereby interlocking the external and internal bodies and eliminating mobility between the two bodies. Similar to the functional expandable implant, an expansion device is placed through an expansion slot. The expansion device lifts the internal body relative to the external body, interlocking the planar plate member of the internal body against the interior of the expansion window, and pushing the mesh structure of the internal body through the expansion window and above the superior surface of the external body. Varying the height of the expansion device and the dimensions of the external and internal bodies allows for various distraction heights to regain disc space. As with the functional intervertebral implant, the PLIF and TLIF cages may take the form of either an expandable lordotic cage or a non-lordotic cage.

Problems solved by technology

However, genetic or developmental irregularities, trauma, chronic stress, and degenerative wear can result in spinal pathologies for which surgical intervention may be necessary.
Such events cause the height of the disc nucleus to decrease, which in turn causes the anulus to buckle in areas where the laminated plies are loosely bonded.
Such practices are characterized by certain disadvantages, most important of which is the actual morbidity of the procedure itself.
Placement of rigid cages or structural grafts in the interbody space either requires an anterior surgical approach, which carries certain unavoidable risks to the viscous structures overlying the spine (intestines, major blood vessels, and the ureter), or they may be accomplished from a posterior surgical approach, thereby requiring significant traction on the overlying nerve roots.
The interval between the exiting and traversing nerve roots is limited to a few millimeters and does not allow for safe passage of large intervertebral devices, as may be accomplished from the anterior approach.
Alternatively, the anterior approach does not allow for inspection of the nerve roots, is not suitable alone for cases in which the posterior elements are not competent, and most importantly, the anterior approach is associated with very high morbidity and risk where there has been previous anterior surgery.
Another significant drawback to fusion surgery in general is that adjacent vertebral segments show accelerated deterioration after a successful fusion has been performed at any level.
Other drawbacks include the possibility of “flat back syndrome” in which there is a disruption in the natural curvature of the spine.
Finally, there is always the risk that the fusion attempt may fail, leading to pseudoarthrosis, an often painful condition that may lead to device failure and further surgery.
As previously discussed, however, cages that would be placed from the safer posterior route would be limited in size by the interval between the nerve roots.
Ultimately though, it is important to note that the fusion of the adjacent bones is an incomplete solution to the underlying pathology as it does not cure the ailment, but rather simply masks the pathology under a stabilizing bridge of bone.
This bone fusion limits the overall flexibility of the spinal column and artificially constrains the normal motion of the patient.
This constraint can cause collateral injury to the patient's spine as additional stresses of motion, normally borne by the now-fused joint, are transferred onto the nearby facet joints and intervertebral discs.
Placement of posterior devices that maintain mobility in the spine have been limited due to the relatively small opening that can be afforded posteriorly between the exiting and transversing nerve roots.
Additionally, placement of posterior interbody devices requires the removal of one or both facet joints, further destabilizing the spine.
Thus conventional posteriorly placed interbody devices have been generally limited to interbody fusion devices.
Also, the anterior approach does not offer the surgeon an opportunity to view the posterior neural elements and thereby does not afford an opportunity for decompression of those elements.
Once an anterior exposure had been utilized a revision procedure is quite risky and carries significant morbidity.

Method used

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Embodiment Construction

[0060] In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part hereof, and in which are shown by way of illustration specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.

[0061]FIGS. 1 and 2 show a round, expandable artificial intervertebral implant designated generally at 10. The device is implemented through a posterior surgical approach by making an incision in the annulus connecting adjacent vertebral bodies after removing one or more facet joints. The natural spinal disc is removed from the incision after which the expandable artificial intervertebral implant is placed through the incision into position between the vertebral bodies. The implant is preferably made of a biocompatible metal having a non-porous quality and a smooth finish, howe...

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Abstract

An artificial functional spinal unit is provided comprising, generally, an expandable artificial intervertebral implant that can be placed via a posterior surgical approach and used in conjunction with one or more artificial facet joints to provide an anatomically correct range of motion. Expandable artificial intervertebral implants in both lordotic and non-lordotic designs are disclosed, as well as lordotic and non-lordotic expandable cages for both PLIF (posterior lumber interbody fusion) and TLIF (transforaminal lumbar interbody fusion) procedures. The expandable implants may have various shapes, such as round, square, rectangular, banana-shaped, kidney-shaped, or other similar shapes. By virtue of their posteriorly implanted approach, the disclosed artificial FSU's allow for posterior decompression of the neural elements, reconstruction of all or part of the natural functional spinal unit, restoration and maintenance of lordosis, maintenance of motion, and restoration and maintenance of disc space height.

Description

PRIORITY CLAIM [0001] This application is a continuation of U.S. patent application Ser. No. 10 / 634,950 entitled “ARTIFICIAL FUNCTIONAL SPINAL UNIT ASSEMBLIES” filed on Aug. 5, 2003, the disclosure of which is hereby incorporated by reference.BACKGROUND [0002] 1. Field of the Invention [0003] The present invention generally relates to functional spinal implant assemblies for insertion into the intervertebral space between adjacent vertebral bones and reconstruction of the posterior elements to provide stability, flexibility and proper biomechanical motion. More specifically, the present invention relates to artificial functional spinal units comprising an expandable artificial intervertebral implant that can be inserted via a posterior surgical approach and used in conjunction with one or more artificial facet joints to provide a more anatomically correct range of motion. [0004] 2. Description of Related Art [0005] The human spine is a complex mechanical structure composed of altern...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61F2/44A61B17/70A61B17/86A61F2/00A61F2/02A61F2/30
CPCA61B17/1671A61B17/1757A61B17/7005A61B17/7008A61B17/7023A61B17/7032A61B17/7037A61B17/704A61B17/7041A61B17/7052A61B17/7064A61B17/86A61B17/8897A61B2017/0256A61F2/30767A61F2/30771A61F2/4405A61F2/4425A61F2002/30133A61F2002/30364A61F2002/30365A61F2002/30369A61F2002/30462A61F2002/30492A61F2002/30507A61F2002/30515A61F2002/30538A61F2002/3055A61F2002/30556A61F2002/30578A61F2002/30579A61F2002/30616A61F2002/30624A61F2002/30649A61F2002/30662A61F2002/3071A61F2002/30785A61F2002/30794A61F2002/30841A61F2002/443A61F2220/0025A61F2220/0033A61F2220/0075A61F2230/0015A61F2250/0006A61F2250/0007A61F2250/0009A61F2250/0085A61F2310/00407A61F2310/00796A61F2310/00976A61B17/746A61F2002/3079
Inventor GORDON, CHARLESHARBOLD, COREY
Owner FLEXUSPINE INC
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