1. Field
The present invention relates to an implantable device. More specifically, the invention is directed to an implantable device configured to be placed anteriorly within a space, and then expand posteriorly within the space to increase the footprint of the device in the space.
2. Related Art
The general use of an implantable device, such as an intervertebral device, is known in the art. Such devices are surgically implanted to facilitate bone grafting in the disc space. However, they have anatomical limitations, they are often complicated to use, and can be costly to manufacture.
One such related device is disclosed in U.S. Pub. No. 2012/0215316 (hereinafter “the '316 publication”). The related device is disclosed as being insertable into the spine via a lateral direction (
The present invention was developed to improve the devices of the related art. In particular, the novel device explained herein differs from any previous devices because it utilizes a novel expansion system and it permits coplanar expansion in either an anterior-posterior or medial-lateral direction depending on the route of placement. Moreover, with the present exemplary embodiments, coplanar expansion can be accomplished either unidirectionally (i.e., anterior or posterior) or bidirectionally (i.e., anterior and posterior simultaneously).
According to a first aspect of an exemplary embodiment, an expandable device for implantation in a body space, includes an outer frame, and an inner frame slidably engaged with the outer frame. The inner frame includes a tapered wall surface. A ratchet is provided for maintaining an expansion state of the device after moving the inner frame relatively away from the outer frame so as to increase an overall size of the device, while the inner frame maintains engagement with the outer frame. The inner frame is configured to expand with respect to the outer frame in a direction perpendicular to a direction of insertion of the device into the body space.
The ratchet may include nubs located on the inner frame and tines located on the outer frame. The nubs on the inner frame might engage with the tines on the outer frame, maintaining an expanded state.
According to another aspect of an exemplary embodiment, there is provided an expansion tool that may be insertable into an opening created by the tapered wall surface of the inner frame and a surface of the outer frame, until the desired expansion state of the device is reached.
According to another aspect of an exemplary embodiment, the outer frame and the inner frame may form one or more openings.
According to another aspect of an exemplary embodiment, the one or more openings may be filled with a bone grafting material.
According to another aspect of an exemplary embodiment, the expandable device may be implanted in an interbody space.
According to another aspect of an exemplary embodiment, a second inner frame may slidably engage with the outer frame. The inner frame and second inner frame may move relatively away from each other, so as to increase an overall size of the device, while the inner frame and second inner frame may maintain engagement with the outer frame.
According to another aspect of an exemplary embodiment, a ratchet system for maintaining an expanded position of an expandable device for implantation in a body space includes nubs located on an inner frame of the expandable device and tines located on an outer frame of the expandable device. The nubs may engage with the tines to maintain an expanded state of the expandable device.
The tines may move over the nubs when the inner frame and the outer frame are moved in a first direction relative to each other and the tines and nubs may prevent the inner frame and the outer frame from moving in a second direction relative to each other.
According to another aspect of an exemplary embodiment, the tines may fail when a sufficient force is applied against the inner frame and the outer frame in the second direction.
According to another aspect of an exemplary embodiment, there is provided a method for using an expandable device for implantation in a body space including inserting an expandable device into the body space. The device may have an inner frame and an outer frame that may be slidably engaged with each other, in an unexpanded state, and inserting an expansion tool into a space created by a tapered wall surface on the inner frame. The inner frame and the outer frame may move relatively away from each other in a coplanar plane, perpendicular to a direction of insertion of the expansion tool, as the expansion tool is further inserted into the space, and withdrawing the expansion tool from the space when a desired state of expansion is obtained.
The expandable device may be inserted into an intervertebral disc space.
The expandable device may be inserted from a lateral approach of the intervertebral disc space.
According to another aspect of an exemplary embodiment, the expansion tool may be inserted into a space defined by the tapered wall surface on the inner frame and a tapered wall surface on a second inner frame. Advancing the expansion tool into the space may move the inner frame and the second inner frame relatively away from each other.
The tapered wall surface on the inner frame may be tapered in a first direction and the tapered wall surface on the second inner frame is tapered in a direction opposite the first direction.
The above and other objects, features and advantages of the present invention will become more readily apparent from the following detailed description of exemplary embodiments of the invention, taken in conjunction with the accompanying drawings, in which:
In the following detailed description, standard vertebral anatomical terms are employed with their ordinary and customary meanings. An “anterior direction” means toward the front of the patient. A “posterior direction” means toward the back of the patient. A “medial direction” is toward the mid-line, while a “lateral direction” is away from the mid-line. A “lateral approach” is an entry from a side of the spine toward the spine, whereas an “anterior approach” is an entry from a front of the patient toward the spine. A “superior direction” is being toward the head, whereas an “inferior direction” is being away from the head.
During lateral/anterolateral spinal interbody fusion it is desirable to place a graft or mechanical expandable device as posterior as possible within a disc space to maximize foraminal expansion. However, the neural elements typically limit posterior placement of the retractor system, particularly at the lower lumbar levels. The novel expandable device described herein can expand posteriorly so as to permit itself to be placed anteriorly within the disc space and then, after placement in the disc space, expanded posteriorly to increase foraminal height, disc height and also increase the footprint of the device.
In addition, the inventor has developed a similar mechanical expandable device that is able to expand bidirectionally, in both an anterior and posterior direction, which permits maximal fusion surface for bone growth.
Furthermore, if the device is placed via a true anterior or posterior approach, its expansion mechanism is configured to permit medial lateral expansion and create a large “footprint” for spinal fusion.
An intervertebral device (also known as a “graft”), illustrated in the accompanying Figures is configured to create the above described expansion. The device length and height are set to predetermined dimensions, depending on the circumstances surrounding the procedure, and optionally filled with bone graft material prior to implantation. It will be understood that the device will be provided in different “kits,” with the user choosing the device with the appropriate dimensions at the time of implantation. Once implanted, the graft is able to expand posteriorly (i.e., unidirectionally) by pushing a tool through an aperture along a side of the graft which forces a sloped portion of the graft to migrate posteriorly. Nubs and tines disposed on projections and overhangs of inner and outer graft portions, respectively, are spaced apart from each other a predetermined dimension, for example 1 mm increments, to facilitate locking of the graft into position and maintaining expansion in the desired position.
In one aspect of the device, the graft may be expanded under radiographic guidance to “dial-in” the exact size. Then, the empty portion of the graft exposed during expansion may be backfilled with bone graft material to fill the empty portion if desired. Alternatively, the empty space would fill over time by a self-expanding bone graft or substitute.
A bi-directionally expanding graft would follow a similar design to the unidirectionally expanding graft, but with the expansion mechanism disposed in a center of the device. If the surgeon wishes to achieve medial to lateral expansion, the device may be placed via a true anterior or posterior approach and opened as noted above for the unidirectional device.
Each and every device described herein may be constructed of various medical grade metals or a synthetic substance such as poly ether ether ketone or carbon fiber, etc., and thus, the foregoing description is not intended to limit the scope of the device. Each device, or element thereof, may be constructed using more than one of the substances described.
Surgical techniques to implant the device include an open surgical approach or via various cannula, tubes or other minimally invasive retractors or delivery systems, or any other surgical approach.
A specific structural configuration and method of using the device will now be explained in conjunction with the enclosed drawing figures.
As shown in
Turning to
The outer and inner frames 110, 120 are secured to each other by a tongue and groove engagement, as seen in
It is understood that this is but one embodiment of the tongue and groove arrangement. As seen in
The device 100 may be pre-assembled, so that the inner frame 120 is already slidably connected to the outer frame 110 by the rails 180 and the grooves 170, or the device 100 may be assembled at the time of use. To assemble the device 100 at the time of use, the rails 180 of the inner frame 120 are placed in the grooves 170 of the outer frame 110 as seen in
The inner frame 120 may include a tapered side edge 130 to facilitate expansion as will be described in more detail later. The outer frame 110 may include tines 112 on the outer frame 110, which engage with nubs 122 on the inner frame 120. The structure of the tines 112 and nubs 122 provides the device with the capability to expand with in a ratchet fashion, wherein the inner and outer frames 110, 120, move with respect to each other incrementally in a controlled manner allowing motion in one direction. This allows the operator to expand the device in a steady motion until a desired size is achieved as discussed in more detail below.
Each of the tines 112 and nubs 122 may be spaced apart from each other by a predetermined dimension. For example, the tines and nubs can be spaced apart in 1 mm increments, to enable ratcheting in small increments until a desired expanded state is obtained. The tines 112 are located on an underside of overhangs 190b, 190d on the side walls 110b, 110d, respectively, of outer frame 110, as seen in
A center point C, C′ is labeled in the drawings for each frame, 110, 120, respectively. The center points C, C′ are imaginary reference points, since the center of the frames are actually open to allow for grafting.
The center points C, C′ are moved relatively away from each other during the act of expansion. As such, a distance between C-C′ is D1 in the unexpanded state, and the distance between C-C′ is D2 in the expanded state, wherein D2>D1. In the embodiment illustrated in
The expansion is facilitated by a wedge action, and an understanding of the wedge action is facilitated by
As the expansion tool 150 inserts further into the space 160 from a lateral direction, it pushes the outer frame 120 in the posterior direction (see
The expansion tool 150 has a first end 152 that interacts with the device 100 and space 160. In a preferred embodiment, the first end 152 of the expansion tool 150 is square in shape with rounded corners. In this preferred embodiment, a body 154 of expansion tool 150 is rectangular. In addition, the expansion tool 150 can be modified at a second end 156 by the user or at the time of manufacturing. Modifications, for example, might give the user a better grip on the expansion tool 150 or aid in expanding the device 100. In a preferred embodiment, the second end 156 is square in shape. It will be understood by one skilled in the art that the first end 152, the body 154, and the second end of the expansion tool 150 can be any other shape necessary to expand the device 100 in a body space and can be modified in any fashion so as to provide the user with the best possible control over the expansion tool 150.
The tool 150, 250 will typically be made of titanium, however, other materials may be used. In particular, the tool material may be the same as the interface wall (i.e., tapered wall) of the inner frame or it may be formed of a metal alloy.
The maximum and minimum expansion distance of the inner frame 120 with respect to the outer frame 110 may be determined in several ways, including the length and angle of tapered wall 130 or the width of the expansion tool 150. As discussed above, the expansion of the device can be more finely controlled by using the expansion tool 150. In addition, the smaller the angle of the wall 130, the less the inner frame 120 will be expanded as the expansion tool 150 is advanced into the space 160. It will be understood the device 100 will be available in multiple sizes to allow the user to choose the length and angle of tapered wall 130, as well as the size of the expansion tool 150, depending on the circumstances surrounding the insertion.
As noted above, the tines 112 are configured to be flexible enough to bend as force is applied, but resilient enough to return to their original upright position. The tines are slanted as illustrated in the
In some embodiments, the force exerted on the device 100 in an interbody space is in a superior-inferior (i.e., vertical) direction, which is perpendicular to the movement of the inner frame 120 with respect to the outer frame 110. The tines 112 move over the nubs 122 when a force is applied against the inner frame 120 by the expansion tool 150 to move inner frame 120 in a first direction E. Therefore, the tines 112 need only be strong enough to prevent inner frame 120 from moving in a second direction E′ back into outer frame 110. Tines 112 can be relatively weak because there is a minimal force in this coplanar direction. Thus, a user can remove the device 100 from an interbody space by applying a sufficient force against the inner frame 120 in the second direction E′, to break the tines 112 and collapse the inner frame 120 back into the outer frame 110. The device 100 may be removed in the same or different manner than which it was inserted. It will be understood that the “sufficient force” necessary to break tines 112 will be determined by material used and the size of the tines 112.
An alternative embodiment of the expandable device is shown in
Each of the inner frames 220A, 220B include a tapered wall 230A, 230B, which tapers inwardly from a side wall of the frame towards a center portion as shown in
Tines 212 are provided on an overhang (not shown) of outer frame 210b, 210d, as seen in
Bone grafting material is provided in the open spaces provided by the expanding device. That is, since the device expands in the anterior-posterior direction, there is an increased surface area for bone growth between adjacent vertebrae. This bigger and wider footprint improves the fusion result. For example, a comparison of the top views of the device in the unexpanded and expanded states, for example in
A method of using the devices 100, 200 will now be described. The spinal column is accessed via traditional open, tubular, minimally invasive, laparoscopic or other accepted methods as shown in
The device 100 can be formed in different sizes to fit different interbody spaces. The different sizes can include different lengths of the frame sides 110a-110d, 120a-120d, the angle and length of the tapered wall 130, the distance between the tines 112 and nubs 122, the length of the expansion tool 150, etc. The inner frame 120 and outer frame 110 are formed so the inner frame 120 will be flush with and slidable within the outer frame 110.
It will be understood by one of ordinary skill in the art that the device 100 may be used to create or maintain a space within a body. In particular, the device 100 may be used to separate two elements in a body. In addition, the device 100 can be inserted and expand to provide a space through which medical devices may be implanted, or to perform other medical procedures requiring the creating of a body space or enlarging of a body space.
The present invention provides an expandable device for implantation in a body space, wherein the device is inserted into the space from a direction which is perpendicular to an expansion direction of the device. Thus, if the device is inserted from a lateral approach, a tool is also inserted from a lateral approach, and the device is expanded in a posterior and/or anterior direction. Some of the advantages gained by this structure include the ability to increase the surface area of bone grafting in the posterior area of the spine, without risking damage to the nerves and while using as small an incision as possible.
While the invention has been shown and described with reference to certain preferred embodiments, it will be understood by those skilled in the art that various changes and modifications in form and detail may be made therein without departing from the spirit and scope of the invention, as defined by the appended claims.
This application is related to, and claims the benefit of priority from, U.S. Patent Application No. 61/788,042, filed on Mar. 15, 2013, the contents of which are incorporated herein by reference in its entirety.
Number | Date | Country | |
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61788042 | Mar 2013 | US |