Central Structures Spreader for the Lumbar Spine
A spinal device and associated method are provided for spreading of first and second vertebral elements, each of the first and second vertebral elements having a circumferential surface defining a vertebral body and a pedicle having a pedicle root portion adjacent the circumferential surface. The device includes a first end member having at least one surface adapted to conform to at least one of the circumferential surface and the pedicle root portion of the first vertebral element, and a second end member having at least one surface adapted to conform to at least one of the circumferential surface and the pedicle root portion of the second vertebral element. The device further includes a resilient member extending between the first and second end members and being adapted to exert a force against the first and second vertebral elements.
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This application is a continuation of U.S. patent application Ser. No. 11/671,615, filed on Feb. 6, 2007, the contents of which are fully incorporated herein by reference.
FIELD OF INVENTIONThe invention relates generally to spinal surgery and, more particularly, to systems and methods for restoring the volume of one or more of intervertebral foramen within a lumbar spine segment.
BACKGROUNDAn intervertebral foramen is an aperture extending generally laterally from the spinal canal dimensioned to accommodate the exiting nerve roots from the spinal cord at a given vertebral level in the spine. Within a single vertebral level, an intervertebral foramen is defined anteriorly by the annulus of the intervertebral disc and the posterior and lateral aspects of the adjacent superior and inferior vertebral bodies, superiorly by the pedicle of the superior vertebra, inferiorly by the pedicle of the inferior vertebra, and posteriorly by the facet joint formed by the inferior articulating facet of the superior vertebra and the superior articulating facet of the inferior vertebra. In a normal, non-pathologic spine, the intervertebral foramen is dimensioned such that the exiting nerve roots are adequately protected from compression and/or other undesirable contact during flexion, extension, lateral bending, and axial rotation of the particular vertebral level. This protection is provided by maintaining the volume of the intervertebral foramen during (or promptly restored after) such movements, as well as under the axial loading that occurs at that vertebral level during activities of daily living.
The spatial integrity or volume of the intervertebral foramen may become compromised due to any of a number of events or pathologies, resulting in a constriction or narrowing of one or more aspects of the intervertebral foramen. These may include, but are not necessarily limited to, degenerative disc disease, disc failure or rupture due to trauma, osteophyte formation and/or calcification of the ligamentum flavum, intervertebral osteochondrosis, scoliosis, and/or destabilization from spine surgery procedures (e.g. discectomy, fusion, total disc replacement, nucleus replacement). When this occurs, the resulting narrowing or constriction (“lateral stenosis”) may cause the exiting nerve root to be compressed by one or more of the aspects that define the intervertebral foramen. Depending on the severity of the condition, this may cause any of a host of problems for the patient, including shooting pain (radiculopathy) and/or impaired motor or sensory nerve function due to the nerve compression. Moreover, the superior and inferior articulating facets may become misaligned (“facet imbrication”) and/or be undesirably compressed against one another, either condition which may be painful and/or adversely affect the proper function of the facet joint.
A variety of techniques have been developed over time for treating spinal pathologies, some of which have the effect of restoring the volume of the intervertebral foramen, but which may be limited by the path of nerve roots extending from the spine. Known techniques for example, do so indirectly through the use of procedures or implants in aspects of the spine remote to or outside of the intervertebral foramen. These procedures include, but are not necessarily limited to, the use of pedicle screw systems (fixed or dynamic) extending between adjacent pedicles, spinous process spacer systems positioned between adjacent spinous processes, plating systems (lateral and/or anterior) coupled between adjacent vertebral bodies, and intervertebral implants (e.g. fusion, total disc replacement, nucleus replacement) positioned between adjacent vertebral bodies. None of these systems or procedures restores the intervertebral foramen volume in a direct manner. Moreover, many of these procedures involve fusing or rigidly affixing the adjacent levels of the spine, such as via interbody fusion, posterior fusion, fusion via plating and/or fusion of the facet joint itself, each of which may limit normal physiologic motion.
A system capable of directly restoring the volume of an intervertebral foramen while not interfering with the path of nerve roots and other anatomical structures is therefore desirable.
SUMMARYIn accordance with an embodiment of the invention, a spinal device is provided for spreading of first and second vertebral elements, each of the first and second vertebral elements having a circumferential surface defining a vertebral body and a pedicle having a pedicle root portion adjacent the circumferential surface. The device includes a first end member having at least one surface adapted to conform to at least one of the circumferential surface and the pedicle root portion of the first vertebral element, and a second end member having at least one surface adapted to conform to at least one of the circumferential surface and the pedicle root portion of the second vertebral element. The device further includes a resilient member extending between the first and second end members and being adapted to exert a force against the first and second vertebral elements.
In other embodiments, the device may include a resilient member having polycarbonate urethane or include first and second end members each having at least one aperture. The aperture in such embodiments may be adapted to direct a bone anchor into at least one of the pedicle root portion and the vertebral body. The first end member may further have a main body portion and the at least one aperture may be laterally offset from the main body portion. In another aspect of the present invention, the spinal device may include a first end member having an exposed surface angled to be in a confronting relationship with an intervertebral foramen such that the at least one aperture extends from the exposed surface.
In another embodiment, a method of spreading first and second vertebral elements apart is provided, with each of the first and second vertebral elements having a circumferential surface defining a vertebral body and a pedicle having a pedicle root portion adjacent the circumferential surface. The method may include the steps of providing a spreading device having first and second end members and a resilient member there between, conforming at least one surface of the first end member against at least one of the circumferential surface and the pedicle root portion of the first vertebral element, and conforming at least one surface of the second end member against at least one of the circumferential surface and the pedicle root portion of the second vertebral element. The method may also include the step of directing a first bone anchor through the at least one aperture in the first end member and into at least one of the pedicle root portion and the vertebral body of the first vertebral element, and directing a second bone anchor through the at least one aperture in the second end member and into at least one of the pedicle root portion and the vertebral body of the second vertebral element.
A method may also include the steps of threadably engaging the first bone anchor with the at least one of the pedicle root portion and the vertebral body of the first vertebral body, ratchetly engaging the resilient member with at least one of the first and second end members, and ratchetly adjusting the position of the resilient member with respect to at least one of the first and second end members.
Advantageously, the embodiments provide a device and corresponding method capable of directly restoring the volume of an intervertebral foramen while not interfering with the path of nerve roots and other anatomical structures. Moreover, by conforming end members to vertebral surfaces defining or lying adjacent the intervertebral foramen, these embodiments permit improved coupling of the device to such surfaces. The devices according to various embodiments of this invention allow for the implant location to be more laterally located relative to the foramen. As a result, this invention allows for distraction outside (lateral) of the foramen which permits the use of larger, more robust devices that may be of less rigid materials than existing devices.
Prior art devices that are placed in the foraminal space risk impacting or contacting the nerve root. Additionally, prior art rigid devices, when used bilaterally, limit the segmental range of motion. The present invention allows for increased segmental motion and the use of appropriate materials (PCU and the like).
Moreover, prior art devices often utilize a flange and an aperture for mounting; whereas, the present invention utilizes bone screws into the cortical area for a more stable connection while allowing for rotational movement between segments. The present invention also offers the advantage of covering the disc opening caused by a prolapse and may prevent a bulged disc.
These and other objectives and advantages will become readily apparent to those of ordinary skill in the art from the following description of embodiments of the invention and from the drawings in which:
With reference to the figures and, more particularly to
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While the surfaces respectively defining the first and second end members 40, 42 are depicted and described with details pertaining to the exemplary embodiment of
With reference to
The central portion 44 is coupled to or integrally formed with the first and second end members 40, 42, has a generally prismatic shape and is made of a resilient material such as polycarbonate urethane (“PCU”) or any other elastic polymer. Fiber reinforcement of the resilient material may be desirable to prevent creep. The central portion 44 in this exemplary embodiment includes a posterior curve so as to allow for minimized obstruction, if required, of nerve roots, the psoas muscle or other structures. The central portion 44 applies a distraction force to the foramen, thereby spreading the inferior and superior vertebrae 12,14 apart, while allowing, due to the flexibility of the material that defines the central portion 44, a greater segmental range of motion compared to ranges of motion provided by known spinal fixation devices.
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The second end member 74 is defined by a lateral plate 86, a bottom face 88 and a front face 90. The lateral plate 86 is shaped and dimensioned to conform to the outer circumferential surface 33 of the superior vertebral body 32. The bottom face 88 is shaped and dimensioned to conform to the pedicle root portion 35 of the pedicle 34 such that, in cooperation with the lateral plate 86, the second end member 74 can securely fit over a portion of the superior vertebra 14 defining the intervertebral foramen 20, such that the first end member 72 is restricted from movement in at least two directions. The front face go is an angled surface adjacent the lateral plate 86 and bottom face 88 and includes a threaded aperture 92 suitable to receive a fastener in the form of a screw 55. Alternatively, the aperture 92 may not be threaded and may be adapted to receive any suitable fastener other than a screw 55. The front face 90 is angled such that a screw 55 or other fastener can be inserted into and through the body of the second end member 74 from the intervertebral foramen 20 and into the pedicle 34, to thereby secure the second end member 74 in place against the superior vertebra 14.
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The second end member 104 is defined by a main body portion 118 and a lateral flange 120 extending from the main body portion 118. The main body portion 118 is partially defined by a back surface 122 shaped and dimensioned to conform to the outer circumferential surface 33 of the superior vertebral body 32. The lateral flange 120 is partially defined by a back surface 124 shaped and dimensioned to conform to the pedicle root portion 35 of the pedicle 34 such that, in cooperation with the main body portion 118, the second end member 104 can securely fit over a portion of the superior vertebra 14 defining the intervertebral foramen 20, such that the second end member 104 is restricted from movement in at least two directions. The lateral flange 120 includes a threaded aperture 126 suitable to receive a fastener in the form of a screw 55. Alternatively, the aperture 126 may not be threaded and may be adapted to receive any suitable fastener other than a screw 55. A screw 55 or other fastener can be inserted into and through the body of the lateral flange 120 and into the pedicle 34, to thereby secure the second end member 104 in place against the superior vertebra 14.
With continued reference to
The lateral flanges 110, 120 and the respective apertures 116, 126 are laterally offset from the main body portions 108, 118 such that potential obstruction of nerve roots and other anatomical structures is minimized. Moreover, lateral offsetting of the points of coupling of the end members 102, 104 to the respective vertebrae 12, 14 permits localization of the distraction force described above along a first axis 127 lateral to a second axis 128 joining the apertures 116, 126 respectively lying on lateral flanges 110, 120.
With reference to
The spreading device 130 includes a resilient member 134 having a longitudinal axis and similar in materials to the resilient members 44, 76, 106 (
With continued reference to
The resilient member 134 includes opposed proximal and distal ends 142, 144 such that the proximal end 142 is coupled as described above to the end member 132 while the distal end 144 is adapted to be coupled in a similar fashion to another end member 132′ (shown in phantom). Persons of ordinary skill in the art will appreciate that the distal end 144 may be adapted to be coupled to an end member 132′ similar to the end member 132 or alternatively to an end member similar to any of the end members described above with reference to the spreading devices 10, 70, 100 or any variation thereof.
With continued reference to
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Advantageously, the spreading devices 100, 100′ may be positioned at positions generally proximate the natural center of rotation 150 of a vertebral body 22, 32, such that the distraction force exerted thereby does not substantially move or alter the location of the center of rotation 150 of the vertebrae 12, 14.
Accordingly, many further embodiments, applications and modifications of the invention will become readily apparent to those of ordinary skill in the art without departing from the scope of the invention and applicant intends to be bound only by the claims appended hereto.
Claims
1. A spinal device for spreading first and second vertebral elements of a spine, comprising:
- a first end member insertable into a lateral aspect of the spine adjacent the first vertebral element;
- a second end member insertable into a lateral aspect of the spine adjacent the second vertebral element;
- a first fastener adapted to secure the first end member to the first vertebral element;
- a second fastener adapted to secure the second end member to the second vertebral element; and
- a resilient member having a longitudinal axis extending from the first end member to the second end member;
- wherein the spinal device is configured to allow movement between the first and second vertebral elements.
2. The spinal device of claim 1, wherein the first end member includes a surface adapted to conform to an outer lateral surface of the first vertebral element.
3. The spinal device of claim 1, wherein the second end member includes a surface adapted to conform to an outer lateral surface of the second vertebral element.
4. The spinal device of claim 1, wherein the resilient member is adjustable to define a distance between the first end member and the second end member.
5. The spinal device of claim 1, wherein the first end member includes a laterally projecting flange having an aperture extending therethrough, the aperture configured to receive the first fastener therein.
6. The spinal device of claim 1, wherein the second end member includes a laterally projecting flange having an aperture extending therethrough, the aperture configured to receive the second fastener therein.
7. A spinal device for spreading first and second vertebral elements of a spine, comprising:
- a first end member insertable into a lateral aspect of the spine adjacent the first vertebral element;
- a second end member insertable into a lateral aspect of the spine adjacent the second vertebral element;
- a first fastener adapted to secure the first end member to the first vertebral element;
- a second fastener adapted to secure the second end member to the second vertebral element; and
- an elastic member coupled to the first end member and the second end member;
- wherein the spinal device is configured to allow movement between the first and second vertebral elements.
8. The spinal device of claim 7, wherein the first and second fasteners are bone screws.
9. The spinal device of claim 7, wherein an axial position of the elastic member with respect to the first end member is adjustable.
10. The spinal device of claim 7, wherein the first end member and the second end member each include a bottom face configured to conform to the first vertebral element and the second vertebral element, respectively.
11. The spinal device of claim 10, wherein the first fastener is configured to secure the bottom face of the first end member against the first vertebral element, and the second fastener is configured to secure the bottom face of the second end member against the second vertebral element.
12. The spinal device of claim 7, wherein the elastic member exerts a distraction force against the first end member and the second end member.
13. A method of spreading first and second vertebral elements of a spinal column, comprising:
- securing a first end member to a first side of the first vertebral element;
- coupling a first end of a flexible intermediate member to the first end member;
- securing a second end member to a first side of the second vertebral element, wherein the first sides of the first and second vertebral elements are on one side of the spinal column;
- coupling a second end of the flexible intermediate member to the second end member; and
- positioning the flexible intermediate member such that the flexible intermediate member applies a distraction force to the first and second vertebral elements;
- wherein the flexible intermediate member is configured to permit movement between the first and second vertebral elements allowing for natural alignment of the first and second vertebral elements.
14. The method of claim 13, wherein the first end member includes a laterally projecting flange having a first aperture configured to receive a first fastener therethrough, the first fastener being adapted to secure the first end member to the first vertebral element; and
- wherein the second end member includes a laterally projecting flange having a second aperture configured to receive a second fastener therethrough, the second fastener being adapted to secure the second end member to the second vertebral element.
15. The method of claim 13, wherein the first and second end members each include a bottom face configured to conform to an outer surface of the first and second vertebral elements, respectively.
16. The method of claim 15, wherein the bottom face of the first end member is secured against an outer surface of the first vertebral element, and the bottom face of the second end member is secured against an outer surface of the second vertebral element.
17. The method of claim 13, wherein an axial position of the flexible intermediate member relative to the first end member is adjustable to control an exposed length of the flexible intermediate member between the first vertebral element and the second vertebral element.
18. The method of claim 17, wherein movement of the flexible intermediate member with respect to the first end member is limited to one direction.
19. The method of claim 18, wherein the one direction is away from the first end member and toward the second end member.
20. The method of claim 13, further comprising:
- securing a third end member to a second side of the first vertebral element;
- coupling a first end of a second flexible intermediate member to the third end member;
- securing a fourth end member to a second side of the second vertebral element;
- coupling a second end of the second flexible intermediate member to the fourth end member; and
- positioning the second flexible intermediate member such that the second flexible intermediate member applies a distraction force to the first and second vertebral elements;
- wherein the second sides of the first and second vertebral elements are on one side of the spinal column are generally opposite the first sides of the first and second vertebral elements.
Type: Application
Filed: Jul 2, 2015
Publication Date: Oct 22, 2015
Applicant: Zimmer GmbH (Winterthur)
Inventor: Guido Casutt (Rickenbach-Sulz)
Application Number: 14/790,846