The present invention relates to methods and devices for correcting spinal deformities in humans and animals.
Spinal deformity, which typically includes transverse, lateral, and/or rotational misalignment of the vertebrae, can consist of various deformities, such as the following: kyphosis (exaggerated forward curvature of the upper spine), osteochondrosis (abnormal growth of the thoracic spine), scoliosis (abnormal curvature usually most notable in the coronal plane, but also including sagittal and rotational misalignment), and spondylolisthesis (displacement of lumbar vertebrae). Other factors resulting in spinal deformity may include, but are not limited to, fractures due to trauma and spondylitis. Techniques for correcting such deformities can be loosely divided into two categories, external and internal. External devices, such as braces, limit the mobility of the patient and are uncomfortable, resulting in low user compliance. Brace technology has therefore been inadequate to correct deformity and may prevent progression and in some cases induce worsened curvature.
Internal techniques for correcting deformity include the fusion of adjacent vertebrae through the immobilization of one or more vertebral element(s) and the distraction of the intervertebral disc space. In most cases, interbody cages and/or bone grafts are placed within the disc space to space the vertebrae and align them in an orientation that promotes fusion while also restoring the previous or desired angular relationship to achieve correct curvature of the spine. While many of these techniques are effective, fusion has negative effects on the range of motion of the patient and may, in cases, cause complications; sometimes severe complications. Furthermore, correction of deformities often requires fusion at multiple levels. Lastly, fusion on one level has so far been ineffective in correcting multilevel spinal deformity.
Thus, there exists a need for improved methods and devices for correcting spinal deformities while preserving motion capability and promoting user compliance.
U.S. Pat. Nos. 6,045,579 and 6,080,193 describe an “Adjustable Height Fusion Device,” which comprises a method and apparatus for promoting spinal fusion between neighboring vertebrae. The apparatus is placed within the intervertebral space and preferably adapted to vary the distance between the engaging plates such that the height of the apparatus proximate the anterior end is greater than the height at the proximate the posterior ends, whereby the natural lordosis of the spine is maintained after the apparatus is installed. An alternative possibility describes the device containing struts with different heights in order to treat scoliosis. The current invention may have differing heights, but also contains an elastic section which applies forces for correction and is not intended for use in fusion.
The suite of U.S. patents, including U.S. Pat. Nos. 6,436,102, 6,447,548, 6,471,725, 6,562,047, 6,607,559, 6,740,119, 6,805,716, 6,837,904, 6,863,689, 6,890,356, 7,153,310, 7,217,292, 7,507,255, 7,550,008, 7,722,675, 8,038,717, 8,216,315, and 8,361,153, describe methods and implantation tools for a distraction method comprising distracting the space between vertebral bones by inserting a spacer, subsequently removing the spacer, and distracting with a wider spacer, all during one surgery. These spacers may be tapered, meaning the upper and lower surfaces are non-parallel such that the spacer comprises a wedge shaped implant. Such a wedge-shaped implant may be used to treat scoliosis by returning proper alignment to vertebral bones. Unlike such a technique covered by that suite of patents, the current invention is not intended for use in fusion and is not a rigid element.
U.S. Pat. No. 6,682,564 consists of an implant where the body may have a tapering height decreasing from the first end face to the second end face, and while also tapering more quickly in the first diagonal direction. The angle between the tapered top and bottom faces may vary depending on where the device is implanted within the spine. The current invention, while it may be wedged, is not a rigid body and is not intended for use in fusion.
U.S. Pat. No. 7,780,733 is an artificial spinal disc implant method for intervertebral disc replacement in which upper and lower brackets are joined together via springs connected to the upper bracket, which rest in spring guide tracks on the lower bracket. The device is intended to simulate the biological human disc. However, the current invention, in a preferred embodiment, uses springs to apply forces rather than absorb shock, which is unlike what is taught by the U.S. Pat. No. 7,780,733 patent and much of the prior art.
U.S. Pat. No. 7,922,767 describes an implant which promotes disc fusion via an inserted coil shaped device or devices. Such devices may be implanted simultaneously with varying heights providing a post-implantation configuration that optimizes the relative position between two vertebrae, thereby allowing for the treatment of scoliosis. The current invention, on the other hand, is not coil shaped and includes elastic sections between endplates.
U.S. Pat. No. 8,097,037 describes a method for correcting a spinal deformity comprising selecting two or more rigid body spinal implants from a plurality of spinal implants, each implant having a wedge-shaped configuration. The current invention taught herein may be wedge shaped, but is not a rigid body, and is intended for use in applying asymmetric forces to the vertebral column, unlike the U.S. Pat. No. 8,097,037 patented technology.
U.S. Pat. No. 8,118,873 describes an artificial vertebral joint for interposition between a superior vertebra and an inferior vertebra, wherein the superior posterior element is configured to engage and articulate with the inferior posterior element and a spacer extending between the superior component and the inferior component, where the spacer may contain an internal mesh component with an elastic core. The current invention may have an elastic core, but, in embodiments, comprises multiple sections for applying asymmetric forces in addition to acting as a shock absorber.
U.S. Pat. No. 8,366,776 comprises a tapered vertebral implant for use in establishing desired spinal curvatures including separate implant bodies. The bodies may include an associated angle between inferior and superior surfaces of the body and may be stacked so that the associated angles are oriented in a different anatomical plane. Such orientation could provide a rigid fixture for fusion in a preferred alignment. The current invention is not rigid as it contains an elastic section and is not intended for fusion.
U.S. Pat. No. 8,377,138 is an intervertebral disc replacement device in which an artificial intervertebral disc is placed within the interbody space. The disc is made up of two parts, where the inner portion is the nuclear area and the outer portion is for structural support. The device may also include a coiled compression spring in the internal disc to provide support; additionally, endplates can be positioned in a wedge shape. The current invention contains an outer portion which is designed not to mimic the annulus of the disc and act in compression, but to actually apply forces to the adjacent vertebrae through extension of a compressed material to realign the vertebrae rather than merely provide the natural space and support between them.
U.S. Pat. No. 8,382,838 is an interbody vertebral replacement in which an elastic center part surrounded by a fibre system is fit into the space between adjacent vertebrae. The center part can be compressed axially by loading in the vertebral column causing a bulge that is restricted by the fibre system, thereby mimicking the in vivo intervertebral disc. Unlike the current invention, the interbody vertebral replacement is only designed to absorb shock. The current invention not only may absorb shock, but it also may contain multiple discrete springs or polymer springs to apply forces to the adjacent vertebrae through extension of a compressed material to realign the vertebrae in addition to responding to the natural loading and movement of the spine.
U.S. Pat. No. 9,034,045 describes an expandable interbody implant device for separating two vertebrae and promoting fusion. The implant complains ramps so that lordosis may be matched. One side of the ramp can be shorter than another side of the ramp with a corresponding difference along ramps. In this manner, a sideways orientation of the spine may be corrected. This device results in fusion of the vertebrae; it is also important to note most deformity is not merely a deformation in the coronal plane. The current invention is not intended for fusion and additionally corrects deformity in more than one plane.
In the above-mentioned patents, it is either claimed or hypothesized that scoliosis may be treated by expansion or applying forces in one plane. However, scoliosis is not a single planar disease. Furthermore, implantation of a rigid, wedge shaped device or a device that may be configured into a wedged shape will result in the fusion of the adjacent vertebrae, which will A) likely not result the correction of scoliosis due to an inability of the static forces to overcome the forces causing or linked to scoliosis, and B) result in the known presence of adjacent level disease, in which fusion at one level results in degeneration and disequilibrial forces at the adjacent levels. It is noteworthy that a dynamic system, such as that taught herein, will facilitate the correction of scoliosis without fusing the vertebrae.
The present invention is directed to specific devices and methods intended for use in the correction of spinal deformity. In one exemplary embodiment, a method for correcting spinal deformity comprises inserting a spinal implant into the disc space formed by adjacent vertebrae. The disc space may have a lateral side adjacent to the concave side of curvature along the vertical axis of the spine (the concave-lateral side) and a lateral side adjacent to the convex side of a curvature along the vertical axis of the spine (the convex-lateral side). The concave-lateral side may be of a lower height than the convex-lateral side due to the curvature of the spine. The method of treating spinal deformity presented in this invention describes the use of asymmetric forces applied to the adjacent vertebrae to realign the vertebral segment and have those forces thereby propagate through the spinal column. The method uses the restoring force of the spring as defined by Hooke's law. If an elastic material is compressed or expanded, thereby becoming displaced, it will exert a force such that it can be restored to its initial position.
The spinal implant used to induce such forces may be comprised of a top and bottom face with a polymer spanning from the top face to the bottom face to be intraoperatively wedged and then inserted in said disc space so that the height of the implant is higher on the concave-lateral side and lower on the convex-lateral side. The polymer may be elastic so that the implant desires to expand on the concave-lateral side and compress on the convex-lateral side, drawing the vertebrae into alignment. The spinal implant can have a footprint that matches or resembles the footprint of the endplates of the adjacent vertebrae, with ridges that increase the surface area between implant and vertebrae to allow for frictional fixation. Forces exerted by the implant may propagate through the spinal column to align vertebrae adjacent to those directly adjacent to the implant.
In another embodiment, an implant is provided that may have a polymer region where the polymer itself is preoperatively wedged so that it is higher on the concave-lateral side and lower on the convex-lateral side.
In a further embodiment, an implant is provided that may have a region interior to the polymer—between the two faces and in some configurations with the polymer—that has an elastic property that matches or resembles the elastic, shock absorbing properties of the previous disc. The interior region may be positioned in a cylindrical area more central than the polymer.
In yet another embodiment, a polymer, as provided, may be divided in multiple sections, so that each section may have a differing height, or each section may have a different elastic property so as to more accurately apply forces that may draw the vertebra into their proper alignment.
In another embodiment, the implant described herein may have discrete springs organized around the interior elastic region, made of metal or polymer, instead of solid polymer springs.
In another embodiment, the device may have spikes, bumps, or similar protrusions that allow for surface matching that creates a frictional interface that promotes fixation of the top and bottom faces to the endplates of the adjacent vertebrae.
The present invention may also be attached to the endplates of adjacent vertebrae via a screw or other fixation system, in certain aspects, where one or more screws may be inserted through threads in either the top or bottom face or both faces and into the endplate. The screws may also be inserted through a protrusion of the implant that exists parallel to a vertical face of an adjacent vertebrae.
The implant described may also exist in multiple sections that are inserted via routes on opposite or varying sides of the spine, having footprints matching or resembling the lateral half of the adjacent vertebral endplate. The implants may or may not connect to the one another via one or more mechanisms, including but not limited to a dowel-to-hole connection, hooks, magnets, and/or screws.
The present invention also describes an implant which consists of a first element which may be comprised of a top and bottom face with a polymer spanning from the top face to the bottom face. The element may be connected via a hinge to a second element which may be comprised of a top and bottom face with a polymer spanning from the top face to the bottom face. The implant may be inserted so that the central axis of the first element is aligned with that of the second element and then the first element is rotated via a mechanism around the hinge so that it may exist parallel to the second within the disc space.
In another embodiment, an implant is provided that may exist in a smaller version, so that two or more similar implants may be inserted via opposite or varying sides of the spine and connected.
The accompanying drawings illustrate certain aspects of embodiments of the present invention and should not be used to limit the invention. Together with the written description the drawings serve to explain certain principles of the invention.
Various embodiments will now be described in detail to provide an understanding of the structure, function, manufacture, and use of the devices and methods disclosed herein. It should be understood that the following discussion of exemplary embodiments is not intended as a limitation on the invention; rather, the following discussion is provided to give the reader a more detailed understanding of certain aspects and features of the invention.
One or more examples of the embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. It will be to those that various modifications and variations can be made in the practice of the present invention without departing from the scope or spirit of the invention; the features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention. All references cited in this application are hereby incorporated by reference in their entireties.
The current invention describes methods and devices for correcting spinal deformities, and in particular, correcting abnormal curvature including most cases of spinal deformity. In embodiments, one or more dynamic implants which exist in a wedge-shaped configuration or exert asymmetrical force to correct wedging are provided. In an exemplary embodiment, one or more implants can be positioned between adjacent vertebra at the apex of curvature to increase the height of the disc space on the concave side and decrease that on the convex side by dynamically applying continuous forces to the endplates of the adjacent vertebrae over time.
Normal spinal orientation is depicted in
In one embodiment, the current invention comprises a method by which an expansive force is applied to one or more concave aspects of the vertebral segment. A tensile force may also be applied to one or more convex aspects of the vertebral segment. Such forces increase disc space height in concave aspects of the vertebral segment and decrease disc height in convex aspects of the vertebral segment. As shown in
In aspects, the implant, which may engage in such a method of correction of deformity, may have various properties. One exemplary embodiment is shown in
In one embodiment, the device may comprise multiple polymer sections (4600) in various shapes depending on what force(s) are desired to be applied and where on the endplates of the adjacent vertebrae the force(s) must or should be applied (see, e.g.,
In order for the device to remain within the disc space, it is preferable, in embodiments, to have as much of a contact with the adjacent vertebrae as possible to create a frictional interface between the plates of the device and the endplates of the adjacent vertebrae. A variety of interfaces can increase the surface area including ridges (see, e.g.,
In order to apply a compressive force, it may be necessary to attach the implant (7100) to the adjacent vertebrae via a screw, attachment, or similar, system (7800) (see, e.g.,
The device may comprise a configuration in which it is divided into two or more parts that make separate implants (8101 and 8102), or two or more parts of the same implant which can be inserted from two or more sides of the disc space (see, e.g.,
Another possible embodiment of the device may require a smaller incision to access the disc space. As shown in, for example,
Such hinged elements may be scaled to a larger size so the one or more devices can be inserted into the disc space with one or more different polymer properties between the top and bottom plates. Such devices are depicted in
One skilled in the art will recognize that the disclosed features may be used singularly, in any combination, or omitted based on the requirements and specifications of a given application or design. When an embodiment refers to “comprising” certain features, it is to be understood that the embodiments can alternatively “consist of” or “consist essentially of” any one or more of the features. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention.
A “vertebral element” includes a vertebrae, a vertebrae disc, a vertebrae above and below a disc, a space between vertebrae, a space in vertebrae, a vertebrae endplate, and/or a portion of a spinal column, alone or together in any combination.
It is noted in particular that where a range of values is provided in this specification, each value between the upper and lower limits of that range is also specifically disclosed. The upper and lower limits of these smaller ranges may independently be included or excluded in the range as well. The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. It is intended that the specification and examples be considered as exemplary in nature and that variations that do not depart from the essence of the invention fall within the scope of the invention. Further, all of the references cited in this disclosure are each individually incorporated by reference herein in their entireties and as such are intended to provide an efficient way of supplementing the enabling disclosure of this invention as well as provide background detailing the level of ordinary skill in the art.
The present application relies on the disclosures of and claims priority to and the benefit of the filing date of U.S. Provisional Application No. 62/715,638, filed Aug. 7, 2018. The disclosures of that application are hereby incorporated by reference herein in their entireties.
Number | Name | Date | Kind |
---|---|---|---|
3867728 | Stubstad | Feb 1975 | A |
4309777 | Patil | Jan 1982 | A |
4759769 | Hedman | Jul 1988 | A |
5123926 | Pisharodi | Jun 1992 | A |
5320644 | Baumgartner | Jun 1994 | A |
5545229 | Parsons | Aug 1996 | A |
5676702 | Ratron | Oct 1997 | A |
5827328 | Buttermann | Oct 1998 | A |
5928284 | Mehdizadeh | Jul 1999 | A |
6045579 | Hochshuler et al. | Apr 2000 | A |
6080193 | Hochshuler et al. | Jun 2000 | A |
6231609 | Mehdizadeh | May 2001 | B1 |
6296664 | Middleton | Oct 2001 | B1 |
6315797 | Middleton | Nov 2001 | B1 |
6436102 | Ralph et al. | Aug 2002 | B1 |
6447548 | Ralph et al. | Sep 2002 | B1 |
6468310 | Ralph | Oct 2002 | B1 |
6471725 | Ralph et al. | Oct 2002 | B1 |
6520996 | Manasas | Feb 2003 | B1 |
6527804 | Gauchet | Mar 2003 | B1 |
6562047 | Ralph et al. | May 2003 | B2 |
6607559 | Ralph et al. | Aug 2003 | B2 |
6682564 | Duarte | Jan 2004 | B1 |
6733532 | Gauchet | May 2004 | B1 |
6740119 | Ralph et al. | May 2004 | B2 |
6770094 | Fehling | Aug 2004 | B2 |
6805716 | Ralph et al. | Oct 2004 | B2 |
6837904 | Ralph et al. | Jan 2005 | B2 |
6863689 | Ralph et al. | Mar 2005 | B2 |
6890356 | Ralph et al. | May 2005 | B2 |
6964686 | Gordon | Nov 2005 | B2 |
7153310 | Ralph et al. | Dec 2006 | B2 |
7217292 | Ralph et al. | May 2007 | B2 |
7331994 | Gordon | Feb 2008 | B2 |
7507255 | Ralph et al. | Mar 2009 | B2 |
7550008 | Ralph et al. | Jun 2009 | B2 |
7722675 | Ralph et al. | May 2010 | B2 |
7731753 | Reo | Jun 2010 | B2 |
7763075 | Navarro | Jul 2010 | B2 |
7780733 | Carver et al. | Aug 2010 | B2 |
7922767 | Sack et al. | Apr 2011 | B2 |
8038717 | Ralph et al. | Oct 2011 | B2 |
8097037 | Serhan et al. | Jan 2012 | B2 |
8118873 | Humphreys et al. | Feb 2012 | B2 |
8172902 | Kapitan | May 2012 | B2 |
8216315 | Ralph et al. | Jul 2012 | B2 |
8298287 | Moumene | Oct 2012 | B2 |
8313529 | Lechmann | Nov 2012 | B2 |
8361153 | Ralph et al. | Jan 2013 | B2 |
8366776 | Heinz | Feb 2013 | B2 |
8377138 | Reo et al. | Feb 2013 | B2 |
8382838 | Baumgartner et al. | Feb 2013 | B2 |
8845730 | de Villiers | Sep 2014 | B2 |
8951300 | Parrish | Feb 2015 | B2 |
9034045 | Davenport et al. | May 2015 | B2 |
9039766 | Fonte | May 2015 | B1 |
9060876 | To | Jun 2015 | B1 |
9237958 | Duggal | Jan 2016 | B2 |
9687354 | Bellas | Jun 2017 | B2 |
10433974 | O'Neil | Oct 2019 | B2 |
20030083749 | Kuslich | May 2003 | A1 |
20040078080 | Thramann | Apr 2004 | A1 |
20050015150 | Lee | Jan 2005 | A1 |
20050027364 | Kim | Feb 2005 | A1 |
20050112397 | Rolfe | May 2005 | A1 |
20050113924 | Buttermann | May 2005 | A1 |
20050251260 | Gerber | Nov 2005 | A1 |
20060085009 | Truckai | Apr 2006 | A1 |
20060142861 | Murray | Jun 2006 | A1 |
20060149381 | Kim | Jul 2006 | A1 |
20060178744 | de Villiers | Aug 2006 | A1 |
20060200239 | Rothman | Sep 2006 | A1 |
20060293753 | Thramann | Dec 2006 | A1 |
20070050032 | Gittings | Mar 2007 | A1 |
20070067037 | Studer | Mar 2007 | A1 |
20070067038 | Studer | Mar 2007 | A1 |
20070088441 | Duggal | Apr 2007 | A1 |
20070168039 | Trieu | Jul 2007 | A1 |
20070191958 | Abdou | Aug 2007 | A1 |
20070270959 | Dubousset | Nov 2007 | A1 |
20080114454 | Peterman | May 2008 | A1 |
20080154375 | Serhan | Jun 2008 | A1 |
20080161919 | Melkent | Jul 2008 | A1 |
20080161920 | Melkent | Jul 2008 | A1 |
20080288074 | O'Neil | Nov 2008 | A1 |
20080312743 | Vila | Dec 2008 | A1 |
20090012623 | Sack | Jan 2009 | A1 |
20090132049 | Carver et al. | May 2009 | A1 |
20090157185 | Kim | Jun 2009 | A1 |
20090192617 | Arramon | Jul 2009 | A1 |
20090292363 | Goldfarb | Nov 2009 | A1 |
20100030335 | Arramon | Feb 2010 | A1 |
20100286783 | Lechmann | Nov 2010 | A1 |
20100331986 | Shikinami | Dec 2010 | A1 |
20110004307 | Ahn | Jan 2011 | A1 |
20110029083 | Hynes | Feb 2011 | A1 |
20110046740 | Chen | Feb 2011 | A1 |
20110245926 | Kitchen | Oct 2011 | A1 |
20110257748 | Liu | Oct 2011 | A1 |
20120065681 | DiLorenzo | Mar 2012 | A1 |
20120089230 | Buttner-Janz et al. | Apr 2012 | A1 |
20120116513 | Carpenter | May 2012 | A1 |
20120191189 | Huang | Jul 2012 | A1 |
20120215316 | Mohr | Aug 2012 | A1 |
20120290089 | Melamed | Nov 2012 | A1 |
20130013074 | Shikinami | Jan 2013 | A1 |
20130023990 | Zipnick et al. | Jan 2013 | A1 |
20130274884 | Matsumoto | Oct 2013 | A1 |
20130274885 | Matsumoto | Oct 2013 | A1 |
20130274886 | Matsumoto | Oct 2013 | A1 |
20140277499 | Ainsworth | Sep 2014 | A1 |
20140303736 | Roussouly et al. | Oct 2014 | A1 |
20150045890 | Lefebvre | Feb 2015 | A1 |
20150057755 | Suddaby | Feb 2015 | A1 |
20150257894 | Levy | Sep 2015 | A1 |
20160000575 | Sawyer | Jan 2016 | A1 |
20160022430 | Wickham | Jan 2016 | A1 |
20160270931 | Trieu | Sep 2016 | A1 |
20160361177 | Biedermann | Dec 2016 | A1 |
20170143502 | Yadin | May 2017 | A1 |
20170143508 | Jensen | May 2017 | A1 |
20170258606 | Afzal | Sep 2017 | A1 |
20180078384 | Suddaby | Mar 2018 | A1 |
20180092754 | Jang | Apr 2018 | A1 |
20180228617 | Srour | Aug 2018 | A1 |
20180235769 | Levy | Aug 2018 | A1 |
20180333272 | Mirda | Nov 2018 | A1 |
20180368981 | Mattes | Dec 2018 | A1 |
20190000634 | Beale | Jan 2019 | A1 |
20190038428 | Stauffer | Feb 2019 | A1 |
20190133783 | Unger | May 2019 | A1 |
20190274841 | Hawkes | Sep 2019 | A1 |
20190314169 | Patel | Oct 2019 | A1 |
20190329544 | Yadin | Oct 2019 | A1 |
Number | Date | Country |
---|---|---|
2004016217 | Feb 2004 | WO |
Entry |
---|
PCT Search Report and Written Opinion in Co-Pending PCT/US2019/045581 (10 pages). |
Number | Date | Country | |
---|---|---|---|
20200046511 A1 | Feb 2020 | US |
Number | Date | Country | |
---|---|---|---|
62715638 | Aug 2018 | US |