The lateral access approach is frequently utilized to deliver interbody fusion cages to the lumbar spine. In comparison to conventional anterior or posterior approaches to the lumbar spine, the lateral approach is thought to minimize posterior and/or anterior tissue damage as well as reduce surgery time, associated blood loss, and infection risk.
When multi-level access to the spine is provided through a single minimal access port, the insertion trajectory to the superior and inferior levels is not parallel to those levels. In addition, direct lateral access parallel to the L4/5 and L5/S1 levels is prevented by the presence of the iliac crest.
Accordingly, the angled trajectory required for lateral access to these lower levels requires the cages to be implanted at a “malpositioned” angle that prevents balanced loading across the vertebral endplates and spine. See
Current spreader and shaver technology includes varying paddle shapes and cutting geometries with rigid drive shafts. US Patent Publication No. 2008-00445966 discloses a chisel cutting guide for excising a portion of a vertebral body.
Conventional dilation systems used in intervertebral fusion procedures are typically rigid and non-steerable. Accordingly, they require a line of sight insertion towards the target disc.
US Patent Publication No. US 2007-0225815 (Annulex) discloses a curved stylet for steering within a disc space Annulex does not disclose an assembly comprising a curved guide wire and a flexible dilator tube.
The present inventors have developed flexible shavers and curved access ports that reduce the above-mentioned access and trajectory problems associated with conventional lateral approaches to the lower spine. The devices and methods of the present invention allow the surgeon to present disc preparation instruments to a disc space in the lower spine in a manner that is parallel to the disc space. Consequently, these devices and methods allow for preparing with less endplate damage and higher preparation symmetry.
Therefore, in accordance with the present invention there is provided a flexible shaver for preparing a vertebral endplate, comprising:
Also in accordance with the present invention there is provided a method of intervertebral disc space preparation, comprising the steps of:
Also in accordance with the present invention there is provided a method of preparing an intervertebral disc space between opposing vertebral endplates, comprising the steps of:
a) inserting a curved (preferably flexible) port into a lateral aspect of the disc space, the curved port having a bore.
Also in accordance with the present invention there is provided a assembly comprising:
a) a curved port having a bore having a transverse cross-section; and
b) a vertebral endplate shaver having a transverse cross-section,
wherein the shaver is disposed within the bore of the curved port,
wherein the transverse cross-section of the bore substantially corresponds to the transverse cross-section of the shaver so as to determine the orientation of the shaver within the bore.
Also in accordance with the present invention there is provided a port for use in preparing an intervertebral disc space, comprising:
a) an outer cannula having a bore, and
b) an inner cannula having a bore having a non-circular transverse cross-section,
wherein the inner cannula is disposed within the bore of the outer cannula.
Also in accordance with the present invention there is provided a port for use in preparing an intervertebral disc space, the port comprising a longitudinal bore therethrough, the bore having a proximal end portion having a transverse cross-section and a distal end portion having a transverse cross-section, wherein the transverse cross-section of the proximal end portion of the bore is greater than that transverse cross-section of the distal end portion of the bore.
Also in accordance with the present invention there is provided a port for use in preparing an intervertebral disc space, comprising:
a) an outer cannula having a bore having a proximal end portion and a distal end portion,
b) an upper insert disposed at least in the distal end portion of the bore, and
c) a lower insert disposed at least in the distal end portion of the bore.
Also in accordance with the present invention there is provided a assembly for providing access to an intervertebral disc, comprising;
Also in accordance with the present invention there is provided a method of accessing a target intervertebral disc, comprising the steps of:
The present invention also relates to an assembly comprising a steerable, curvable guide wire and a set of flexible dilator tubes having sequentially increasing bore diameters. When a flexible dilator tube is passed over the curved guide wire, the flexible dilator tube curves in an arc substantially similar to that of the curved guide wire. Thus, the set of curved dilator tubes can open up a curved access path to the L4/5 and L5/S1 levels that previously could not be directly accessed due to the presence of the iliac crest.
Also in accordance with the present invention there is provided a flexible shaver for preparing a vertebral endplate, comprising:
a) a shaft having a proximal end portion and a distal end portion,
b) a handle attached to the proximal end portion of the shaft, and
c) a shaving head attached to the distal end portion of the shaft, the head comprising:
Also in accordance with the present invention there is provided a method of performing a procedure on a spine, comprising the step of:
a) advancing an instrument along a curved path, the path being substantially in a coronal plane, towards a lateral aspect of an intervertebral disc.
a-c discloses various shavers of the present invention having a universal joint, wherein the shavers are presented in varying degrees of angulation.
d-e discloses a universal jointed shaver of the present invention preparing an endplate in the lower spine through a port of the present invention.
a-b discloses various shavers of the present invention having a bendable shaft, wherein the shavers are presented in varying degrees of angulation.
c-d disclose a flexible port in its straight and curved configuration.
a-4b disclose a reinforced flexible port in its straight and curved configuration.
c-4d disclose a slotted port in its straight and curved configuration.
a and b present a perspective view of a port of the present invention, wherein the securement feature is respectively retracted and advanced.
a presented an exploded version of a port of the present invention comprising an outer cannula and an upper insert.
b presented an assembled version of a port of the present invention comprising an outer cannula and an upper and lower insert.
c presents the port of
a-c disclose advancing a shaver through the docked port of
d discloses a handled port of the present invention.
a-b disclose cross-sectional views of the port of
a discloses a steerable catheter having a guide wire extending therefrom.
b discloses the steerable catheter of
c discloses a steerable catheter displaying various degrees of curved tips.
a discloses three flexible dilation tubes and a steerable catheter.
b discloses an assembly of three flexible dilation tubes and a steerable catheter.
c-e disclose telescoping dilation tubes.
The present invention relates to flexible spreaders and shaver devices and methods for parallel preparation of an intervertebral disc space in the context of a non-parallel access trajectory. The flexible shavers utilize curved guide tubes to enable their placement, insertion, flexing, bending and/or pivoting in the disc space.
In some embodiments, the flexible shaft can have a flexibility-imparting geometry that includes use of at least one of a) a spring (available from SS White of Piscataway, N.J.), b) a slotted tube (available from Necomed of Hicksville, Ohio), and c) a standard universal joint. Now referring to
Therefore, now referring to
a) a shaft 19 having a proximal end portion 21 and a distal end portion 22,
b) a handle 15 attached to the proximal end portion of the shaft, and
c) a shaving head 23 attached to the distal end portion of the shaft, the head comprising:
d and 2e shows flexible shavers 11 of this embodiment disposed within respective disc spaces, wherein the shaving heads are disposed parallel to the disc space. Therefore, use of the shaver results in shaved endplates that are substantially parallel to the natural endplates, and so will easily accommodate a lateral fusion cage without causing asymmetry.
The flexible spreader/shaver comprises a distal rigid or non-rigid shaver head having a blade. This shaver head is attached to a partially flexible drive shaft that is in turn connected to a proximal handle. The handle is rotated to turn the drive shaft and the shaving head. The flexible shaft allows variable angulations of the handle relative to the shaver blade, thereby allowing the surgeon to use an angled approach to prepare the disc space in a manner that nonetheless keeps the shaving head substantially parallel to the disc space. Typically, the shaver angulation angle α relative to the drive shaft can be up to 90 degrees, but is preferably between 10 and 45 degrees. In some embodiments, the shaving head of the flexible shaver has a bullet tip 26 for ease of entry into the disc space.
Now referring to
Therefore, now referring to
The flexible shaft can be made flexible in many different ways. For example, in some embodiments, the flexible shaft is made of a flexible material. In other embodiments, the geometry of the shaft imparts flexibility thereto. In some embodiments thereof, the flexible shaft has a universal joint. In other such embodiments, the flexible shaft is slotted to impart flexibility. In other such embodiments, the flexible shaft comprises a spring.
c-d disclose a flexible port 2 in its straight and curved configuration.
a-4b disclose a flexible port 4 having reinforcements 6, the port being in its straight and curved configuration.
c-4d disclose a port having slots 8 in its straight and curved configuration.
In some embodiments, a flexible port is used to dock onto a bone adjacent the disc space and thereby guide disc space preparation instruments into the disc space in a minimally invasive manner. The flexibility allows the port to curve at its distal end portion to produce a curve having an angle of, for example, 20 degrees. This curve allows a shaver to enter the port at a downward trajectory (which occurs when using a single spinal access site for multiple levels) and then orient parallel to the endplates (in order to best prepare the endplates). In some embodiments, the angle of the shaver is between 10 and 45 degrees.
Now referring to
Now referring to
a) an outer cannula 34 having a bore, and
b) an inner cannula having a bore having a non-circular transverse cross-section,
wherein the inner cannula is disposed within the bore of the outer cannula.
Preferably, the port further has features that allow it to securely dock onto the vertebral bone adjacent the disc space. Preferably, this comprises a securement feature disposed upon a distal end portion of at least one of the outer cannula and inner cannula.
In some embodiments, the port having the inner and outer cannulae has a distal end portion that is curved. In some embodiments thereof, the curve in the distal end portion is between 10 and 45 degrees. In some embodiments, the cannulae are made of flexible materials, while in others each cannula has a geometry that imparts flexibility. Because the shaver typically has a much smaller cross-section than the typical lateral cage implant, it is expected that the areal-cross section of the bore of the inner cannula will be much smaller than the areal cross-section of the bore of the outer cannula. For example, in some embodiments, the bores of the cannulae each have an areal cross section, wherein the areal cross section of the bore of the inner cannula is less than 50% of the areal cross section of the bore of the outer cannula. More preferably, the areal cross section of the bore of the inner cannula is less than 25% of the areal cross section of the bore of the outer cannula. Preferably, the inner cannula is modular in order to customize for various angles of approach and inner geometry to guide various instruments. Thus, in some such embodiments, the inner cannula comprises upper 37 and lower 39 inserts having opposing faces 38,40. Preferably, the opposing faces each comprise a longitudinal groove 45,46 therein. These opposing grooves may help form the bore through which the shaver passes. Therefore, these grooves dictate the orientation of the shaver passing therethrough. Preferably, the lower insert is disposed only in a curved distal end portion of the port. This allows for easier access to the disc space in the portion of the port in which shaver head orientation is not critical.
In one particular embodiment thereof, the port comprises an outer cannula having a bore, and an inner cannula (disposed within the bore of the outer cannula) having internal guiding features. In these embodiments, these internal guiding features (such as grooves 45,46 and ridges) only allow the shaver is to be inserted into the disc space in such an orientation that the cutting surface of the shaver is parallel to the disc space.
The port can have variable distal angulations β within its distal end portion to ensure “snug” docking and control shaver angulations. The internal geometry of inserted or assembled port directs shaver into the disc space and maintains the axis of rotation.
Still referring to
Preferably, the port having the larger proximal bore has a distal end portion that is curved in order to insure proper orientation of the instruments passing therethrough. Preferably, the curve in the distal end portion is between 10 and 45 degrees.
In some embodiments, the transverse cross-section of the proximal end portion of the bore is defined by an upper insert, and the transverse cross-section of the distal end portion of the bore is defined by a lower insert and an upper insert. These embodiments possess larger proximal bores whose advantages are discussed above. The inserts may be tailored to specifically and particularly accommodate and orient the different instruments that enter the port.
Thus, now referring to
Preferably, the lower insert is disposed only in the distal end portion of the bore. Its absence in the proximal portion provides room for the surgeon to maneuver the shaver in the proximal portion of the port. Preferably, the upper insert is disposed in both the proximal and distal end portions of the bore. This is advantageous because it improves the ease and insertion along the entire length and provides the superior internal geometry to control insertion angle and axis of rotation. Preferably, the proximal end portion of the bore is straight, and the distal end portion of the bore is curved. The straight proximal end portion of the bore allows for accurate placement of the distal end portion of the port near the target disc space. Preferably, the distal end portion of the upper insert has a face 38, and the lower insert has a face 40, and the faces oppose each other, thereby forming a bore therebetween that dictates the orientation of the shaver passing therethrough.
Thus, and now referring to
a) a curved port 91 having a bore having a transverse cross-section; and
b) a vertebral endplate shaver 95 having a transverse cross-section,
wherein the shaver is disposed within the bore of the curved port,
wherein the transverse cross-section of the bore substantially corresponds to the transverse cross-section of the shaver so as to determine the orientation of the shaver within the bore.
In some embodiments, the curved port has a distal end portion 33 having a securement feature 35 for securing the curved port to vertebral bone adjacent the target disc space. Preferably, the shaver is bendable so that it can pass through the curved portion of the port. In some embodiments thereof, the bendable shaver has a shaft 96 made of a flexible material, while in others the bendable shaver has a shaft having a universal joint.
In one prophetic method of practicing the present invention, the curved port enters the patient through an incision made in the skin. It then proceeds towards the target disc by manual advancement. Once in the general area of the target disc, the distal portion 33 of the port is then bent by advancing it over a steerable catheter that has itself been bent (as explained below). This leaves the distal end portion of the port adjacent the target disc. The securement tooth is advanced into a neighboring vertebral body to stabilize port placement. After the disc space is cleared, the flexible shaver is then advanced through the curved port and into the disc space. The inner features of the curved port guide the shaver's angulation with respect to the disc space. Once the shaver has been suitably placed, the handle and drive shaft of the shaver are rotated to scrape disc tissue and endplates in a plane that is parallel to the disc space.
Therefore, in some embodiments, there is provided a method of preparing an intervertebral disc space between opposing vertebral endplates, comprising the steps of:
a) inserting a curved port into a lateral aspect of the disc space, the curved port having a bore.
d discloses a port 91 and shaver 95 of the present invention.
a-b disclose cross-sectional views of the port-shaver assembly of
Preferably, the insertion is in a substantially coronal plane, as is generally the case for lateral implants. Preferably, the curved port has a substantially straight proximal end portion and a curved distal end portion. Preferably, the curved distal end portion of the curved port is docked to a vertebral body and is oriented substantially parallel to the opposing vertebral endplates in order to dictate endplate preparation that is parallel to the endplates. Preferably, the curved port has a distal end portion having a securement feature, through which docking of the port to a vertebral body occurs. This provides secure attachment of the port to a neighboring vertebral body.
In other embodiments, the method further comprises the steps of:
Now referring to
In some embodiments, a distal end portion 105 of the catheter includes a neuromonitoring sensor or electrode 141. This sensor connects to an external neuro-monitor as the catheter is advanced into the abdomen under fluoroscopic imaging. The function of this sensor is to detect the presence of nerves as the catheter tip is directed towards the target disc.
Once the tip is safely placed against a lateral portion of a disc, a guide wire 139 is advanced through the steerable tip and into the disc. In some embodiments, the electrode 141 can be a neuromonitoring band for sensing adjacent neural tissue. The function of this guide wire is to anchor the initial catheter in the disc and set the trajectory for the subsequent advance of dilation tubes.
In some embodiments, the steerable catheter and guidewire system is the VASCOCATH™, available from Polydiagnost of Pfaffenhofen, Germany.
Now referring to
The flexible nature of these dilation tubes allows them to curve and thereby provide a parallel trajectory for instruments and implants laterally approaching the L4/L5 or L5/S1 disc spaces.
Therefore, and now referring to
Preferably, the steerable tip is curved, thereby imparting a curve upon the longitudinal axis of each of the first and second flexible dilator tubes. Preferably, each of the first and second dilator tubes has a proximal end portion and a distal end portion, and wherein the curve upon the longitudinal axis of each of the first and second flexible dilator tubes is located in the distal end portion of each tube.
In some embodiments, the catheter further comprises a guide wire.
In some embodiments, and now referring to
In some embodiments, each of the first and second flexible dilator tubes has a frustoconical distal end.
In accordance with the present invention, there is provided an assembly for providing access to an intervertebral disc, comprising;
In accordance with the present invention, there is provided a method of accessing a target intervertebral disc, comprising the steps of:
c-e disclose telescoping dilation tubes. In
Now referring to
This application claims priority from U.S. Ser. No. 61/358,220, filed on Jun. 24, 2010, and entitled “Instruments and Methods for Non-Parallel Disc Space Preparation”, the specifications of which is incorporated by reference in its entirety. This application claims priority from U.S. Ser. No. 61/379,194, filed on Sep. 1, 2010, and entitled “Flexible Vertebral Body Shavers”, and is related to non-provisional U.S. Ser. No. 13/163,496, filed on even date, entitled “Flexible Vertebral Body Shavers”, the specifications of which are incorporated by reference in their entireties. This application claims priority from provisional application U.S. Ser. No. 61/385,958, filed Sep. 23, 2010, and entitled “Multi-Segment Lateral Cages adapted to Flex Substantially in the Coronal Plane”, the specification of which is incorporated by reference in its entirety. This application claims priority from provisional application U.S. Ser. No. 61/410,177, filed Nov. 4, 2010, and entitled “Multi-Segment Lateral Cages adapted to Flex Substantially in the Coronal Plane”, the specification of which is incorporated by reference in its entirety. This application is related to non-provisional U.S. Ser. No. 13/163,517, filed on even date, entitled “Multi-Segment Lateral Cages adapted to Flex Substantially in the Coronal Plane”, the specification of which is incorporated by reference in its entirety. This application claims priority from provisional application U.S. Ser. No. 61/397,716, filed Nov. 30, 2010, and entitled “Lateral Spondylolisthesis Reduction Cage”, and is related to non-provisional U.S. Ser. No. 13/163,427, filed on even date, entitled “Lateral Spondylolisthesis Reduction Cage”, the specifications of which are incorporated by reference in their entireties. This application claims priority from provisional application U.S. Ser. No. 61/466,302, filed Mar. 22, 2011, and entitled “Universal Trial for Cages”, and is related to non-provisional U.S. Ser. No. 13/163,397, filed on even date, entitled “Universal Trial for Cages”, the specifications of which are incorporated by reference in their entireties.
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