# Patent

## Title
Method and device for treatment of the spine

## Abstract

A device and method of positioning materials in a spine using an arcuate tool and introducer. Materials may be positioned as desired, such as against an inner annular wall of an intervertebral disc or vertebral body. The arcuate tool retains its predetermined arcuate shape when no pressure or force is applied to the tool, and is positioned by manipulating the tool relative to an introducer and the spine, with the introducer manipulated relative to the spine.

## Background
Applicant claims the benefit of U.S. application Ser. No. 11/972,815 filed Jan. 11, 2008.
Applicant claims the benefit of U.S. application Ser. No. 11/112,475 filed Apr. 23, 2005, now Issued U.S. Pat. No. 7,322,962 issued Jan. 29, 2008, which claimed the benefit of U.S. Provisional Application Ser. No. 60/564,838 filed Apr. 23, 2004, and which claimed the benefit of U.S. Provisional Application Ser. No. 60/572,930 filed May 20, 2004, and which claimed the benefit of U.S. Provisional Application Ser. No. 60/586,627 filed Jul. 9, 2004 and which claimed he benefit of U.S. Provisional Application Ser. No. 60/588,582 filed Jul. 16, 2004, and which claimed the benefit of U.S. Provisional Application Ser. No. 60/588,587 filed Jul. 16, 2004.


FIELD OF INVENTION
This invention and method relate to the treatment of spine or evacuation of components of the spine.
BACKGROUND OF THE INVENTION
The intervertebral disc is comprised of an outer annulus fibrosis and an internal nucleus pulposus. The healthy annulus is comprised of 10-20 lamellae forming a concentric ring of collagen and elastic fibers around the nucleus while the healthy nucleus pulposus is ovoid and composed of a gelatinous mucoprotein within the confines of the annulus fibrosis.
In the healthy normal disc, the annulus is thick and the internal wall is strong and without significant defects. Aging and trauma cause multiple and varied defects of the annulus as well as changes in the nucleus. These defects are a source of pain for many individuals. It is widely accepted that the defects which actually do cause pain are either posterior or postero-lateral. By far, it is most common that symptomatic defects are posterior and/or unilateral postero-lateral. Symptomatic defects which are posterior and bilateral postero-lateral certainly do exist but are definitely less common. On the other hand, degenerative changes with defects along the inner annular wall can be found commonly in various other segments of the inner annular wall (anteriorally, antero-laterally on either or both sides, and laterally on either or both sides. These defects are understood to be asymptomatic, but nevertheless are common.
Radiofrequency is used to treat internal intervertebral disc disruption. Forward pressure is applied to circumvent the nucleus adjacent to the inner annular wall, leverage with the forward pressure against the annular wall opposite to the portion attempting to be treated, or drive through the annular tissue which is intended to be treated.
The catheter is advanced around the inside of the nucleus pulposus adjacent to the inner annular wall. However, in the spectrum of discs requiring treatment, ideal discs are infrequently encountered. The result is that the tip of the catheter, even with a bent and/or capped tip gets caught in defects in the wall, making the advancement difficult or impossible. This frequently results in kinking of the catheter (which then typically must be removed), lodging into the defect (presumably worsening the defect), going through the annular wall (obviously creating a through and through defect in the annular wall and even potentially puncturing or damaging nerve or vascular structures), and ultimately making the intended treatment sub-optimal or even impossible. Additionally, in such situations there has been further damage caused to the disc by the catheter. The defects into which the catheter can inadvertently probe can be the defect, or defects, intended to be treated. Alternately, a defect in the anterior, antero-lateral, or lateral wall can equally be entered inadvertently and cause a disruption of the procedure. Degenerative disc walls commonly contain multiple such defects, as well as thinning of the wall, which are all too frequently penetrated.
The insertion of material into the disc or vertebral body can strengthen a diseased or damaged disc or vertebral body. Such materials may be man-made, or the materials may be biological materials. Regenerative materials show great promise in regenerating damaged and diseased tissue. Proper positioning of these materials within a disc or a vertebral body may be important in achieving desired results.
SUMMARY OF THE INVENTION
The invention is device and method for positioning materials within an intervertebral disc or vertebral body. The device and method allow positioning of the material at substantially all points of the disc and vertebral body, and particularly on the posterior and postero-lateral portions of the inner annulus of the disc. An introducer facilitates insertion of the elongated placement tool. The arcuate, and preferably S-shaped, elongated placement tool is formed within a guide or lumen of the introducer, and the elongated placement tool assumes its predetermined arcuate shape when no pressure or force is applied to the tool by the introducer.
In another embodiment, an elongated tool is used to progressively remove material from the interior of the mammalian intervertebral disc or vertebral body.



DESCRIPTION OF THE DRAWINGS
FIG. 1 shows a partial lateral view of a portion of a human spine.
FIG. 2 is a sectioned view taken essentially along line 2-2 of FIG. 1
FIG. 3 demonstrates a device for placing material or objects and removing material or objects and positioned within an intervertebral disc or vertebral body.
FIG. 4 is an exploded view showing the introducer, non-conductive sheath, stylet and catheter.
FIG. 5 shows the introducer with stylet in place and having penetrated the annular wall of the disc.
FIG. 6 shows the introducer with the stylet removed.
FIG. 7 shows the non-conductive sheath inserted into and through the introducer, with the S-shaped catheter advanced through the sheath.
FIG. 8 shows the S-shaped catheter extended as required through the sheath.
FIG. 9 demonstrates the introducer and sheath being retracted to position the catheter.
FIG. 10 shows the introducer and sheath retracted, and the catheter positioned against the inner annular wall defect.
FIG. 11 demonstrates the device being withdrawn from the disc and the iatrogenecally created defect being sealed.
FIG. 12 demonstrates a range of permissive angles of insertion of the introducer relative to the disc.
FIG. 13 demonstrates the introducer penetrating the annular wall at a different angle from that shown in FIGS. 5 through 11.
FIG. 14 demonstrates another angle of entry of the introducer into the disc.
FIG. 15 demonstrates a catheter having multiple orifices therein through which materials may be dispensed.
FIG. 16 is a sectioned view of an introducer inserted into a sheath having ports therein.
FIG. 17 is a sectioned view of an introducer having ports through which materials may be inserted into the disc, or from which materials may be removed, such as by vacuuming, and also showing a cutter therein.
FIG. 18 demonstrates an introducer and stylet penetrating a disc.
FIG. 19 demonstrates the flexible tip bending on contact with the inner annular wall.
FIG. 20 demonstrates a cutter which may be used to remove material from the disc.
FIG. 21 demonstrates removal of a path of disc material using a cutter and a lavage/suction.
FIG. 22 demonstrates a progressive step in removing material from the disc.
FIG. 23 demonstrates an additional progressive step in removing material from the disc.
FIG. 24 demonstrates yet an additional step in removing material from the disc.
FIG. 25 is a sectioned view of an introducer with a trocar present therein.
FIG. 26 is a sectioned view of the introducer with a retractor therein.
FIG. 27 is an oblique partial view of a mammalian spine.
FIG. 28 is an oblique partial view of the mammalian spine with a retractor in position.
FIG. 29 is a sectioned view of a sheath.
[FIG. 30 is a sectioned view of a sheath and introducer with a cutter, fiber optic source and lavage and suction in place.
FIG. 31 is plan view of a mammalian intervertebral disc showing a portion of the disc evacuated according to the method of the invention.
FIG. 32 shows placement of a support member within the intervertebral disc.
FIG. 33 shows a progressive step of the disc being evacuated according to the method of the invention.
FIG. 34 shows an additional support being positioned within the disc.
FIG. 35 shows an additional progressive step of the disc being evacuated according to the method of the invention.
FIG. 36 shows an additional support being positioned within the disc.
FIG. 37 shows an additional progressive step of the disc being evacuated according to the method of the invention.
FIG. 38 shows an additional progressive step of the disc being evacuated according to the method of the invention.
FIG. 39 demonstrates a device for removing material or objects and from a vertebral body or intervertebral disc.



DESCRIPTION OF PREFERRED EMBODIMENTS
Turning now to the drawing figures, FIG. 1 shows a partial view of a mammalian spine, and more particularly, a human spine 2. FIG. 2 is a sectioned view taken essentially along line 2-2 of FIG. 1, and shows an annular wall of a disc 4 of a human spine. The inner annular wall is rough, or jagged, due to trauma, aging and/or disease. Treatment of the portion of the disc labeled 6 is indicated due to its condition. Advancement of a catheter into the disc, and around the wall of the disc to the area to be treated is difficult, since the tip of the catheter is likely to engage the rough, jagged inner annular wall. The catheter is preferred to be laid against the portion of the disc intended to be treated, minimizing the course of the catheter within the disc, yet assuring good contact of the catheter with the portion of the disc to be treated. The angle of entry into the disc should be maximized to accommodate a spectrum of operative conditions and introducer/needle placements. The portion of the disc requiring treatment as contemplated in this embodiment is postero-lateral (one side or both), plus or minus a portion of the posterior wall. The route to the interior of the disc must be straight. For humans, the distance from the outer layer of skin to interior of the disc is approximately 12 to 30 centimeters, depending upon the size of the individual upon which the process is performed.
FIG. 4 shows the primary elements of the apparatus of the present invention. A stylet 8 is inserted into an introducer 10. A lumen in the form of a sheath 12 is subsequently inserted into the introducer, and a catheter 14 having a preformed S shape is advanced through the sheath. The lumen acts as a guide through which the S-shaped tool such, catheter, is transported. The guide may take other forms that will assist transportation of the tool into the disc, such as a track or a wire that the tool engages. In one embodiment, the guide is part of the introducer, such as a lumen formed therein. The introducer is preferred to be straight for ease of placement and due to the distance from the skin to the interior of the disc. The introducer will generally have a length in excess of 10 centimeters.
The stylet and introducer, which may be needle like, form a passage into the disc through the posterior wall of the disc on the side opposite that requiring treatment. The stylet is intended to keep the tissue from accumulating within the advancing introducer.
The introducer is advanced under fluoroscopic guidance lateral to the superior articular process. The annulus is punctured and the introducer may be advanced initially approximately one-third to one-half of the distance of the disc, as can be judged by operators skilled in performing such procedures.
FIG. 5 shows the introducer with stylet in position. The sharp point of the stylet is driven through the wall of the disc, along with the introducer. The stylet is then removed. FIG. 6.
After the stylet and introducer pierce the annular wall of the disc and access the interior of the disc, the stylet is removed and is replaced with a lumen, which may be a sheath. A pre-formed, S-shaped catheter or other tool having memory retention properties is contained within the straight sheath. The straight sheath is inserted through the introducer for introduction into the disc. The catheter is straightened by the pressure from the walls of the sheath, but the catheter regains its S-shape as it exits the sheath.
The sheath locks into place at the external end of the introducer. When locked into place, the catheter sheath will protrude from the tip of the introducer. The sheath remains well contained within the disc nucleus and not in the proximity of the opposing annular wall but may be advanced or retracted as necessary for catheter positioning.
The sheath is preferred to be made of nonconductive material having thermal insulative properties sufficient to avoid undesired heating of tissues and structures outside of the disc, even if the heating portion of the catheter comes into close proximity or even contact with this sheath. The sheath may be straight, or slightly curved, and capable of advancing through the introducer once the stylet is removed. It has sufficient rigidity to maintain a portion of the catheter in a straight position while that portion of the catheter is in the sheath. The sheath is capable of externally locking at an upper portion into the introducer at the hub.
The non-conductive catheter sheath ensures that no inadvertent heating of the introducer occurs. Heating may cause significant unwanted damage to skin, subcutaneous tissue, fat, muscle, and even nerve.
The sheath is inserted into the lumen of the introducer, while the introducer remains in position within the disc as shown in FIG. 6. In FIG. 7, the catheter is advanced through the sheath. As the S-shaped catheter exits the sheath within the interior of the disc, the catheter, due to memory retention properties, and with no pressure applied, assumes its S-shape, as shown in FIG. 7. In FIG. 8, the catheter continues to advance and contacts the lateral inner annular wall of the side on which the postero-lateral wall is to be treated. Catheter advancement may be fluoroscopically monitored.
FIG. 9 demonstrates the introducer being retracted from the disc as the catheter is advanced. This combination of movements causes the catheter to move toward the postero-lateral and posterior wall which is the intended side of treatment. As shown, the introducer and sheath are retracted until the catheter is in position against the site to be treated. Positioning of the sheath and the catheter may be monitored fluoroscopically.
As shown in FIG. 10, the introducer is retracted until the catheter rests against the lateral posterior wall to be treated. The lateral posterior wall to be treated is opposite the side of the posterior wall that the introducer has penetrated. Heat or radio frequency can be applied to the disc wall by means of the catheter. Other therapeutic procedures may be applied by use of an appropriate catheter. The catheter may then be retracted, and the introducer is retracted from the disc as shown in FIG. 11. Either the tip of this catheter can be differentially heated to seal the entry defect, or the S shaped catheter is removed and replaced with a straight catheter with a heating element at the tip. Heating of the tip as the introducer and elongated tool, such as the catheter, are withdrawn seals the entry defect. Alternately, a catheter with a portal at the tip to inject a sealant of this entry defect may be used.
For positions between the extremes of acute and obtuse, the length of sheath or elongated tool versus disbursed catheter will determine the position at which the catheter tip will come into contact with the opposite lateral wall. Recognition of the goal of having the catheter contact the mid portion of the lateral wall of the side to be treated, and monitoring progress under fluoroscopy will facilitate ideal catheter placement.
In this embodiment, the portion of the elongated tool, such as a catheter, has an S shape when no material pressure or force is applied to the catheter. The catheter may be formed of nitinol, which is sufficiently flexible to be advanced through a straight lumen or sheath, but will regain the preformed arcuate or S-shape when present within the interior of the disc. The catheter should also be sufficiently flexible to conform to the shape of the disc wall, such as the posterior wall of the inner disc, when positioned against the wall. FIG. 10.
The S-shaped catheter allows the physician to treat the posterior wall, and particularly the lateral posterior wall, of a defective disc without the necessity of first contacting the anterior wall with the catheter. The device and process prevent the end or tip of the catheter from catching or hanging against the rough interior annular wall, which may have many crevices that make it difficult to advance the catheter along the wall. The S-shaped catheter allows the catheter to be introduced into the interior of the disc, and then positioned by manipulation of the introducer and catheter, without subjecting the catheter to being snagged by defects in the disc. The S shape facilitates good contact of the catheter with the postero-lateral segment of the disc even if the angle of the introducer entry is suboptimal. Additionally, the S shape retards the catheter traversing through any large segment of the interior of the disc which is typically filled with debris. This minimizes “shoveling” of the debris toward the segment of the inner annular wall to be treated.
Catheters may contain heating segments of various lengths. A final heating element, which is contained in each of these types of catheters, may be present directly at the tip, and is used for the spot sealing on exit from the inner annular wall. An additional embodiment has a straight catheter with a heating element at the tip.
On withdrawal of the catheter, the end or tip of the catheter straightens as it is exiting the annular wall. Spot heating at this position by tip 16 seals the defect that was created by the introducer and catheter.
FIG. 12 demonstrates an acceptable range of angles of introducer insertion 18 when driving the introducer into the disc. The acceptable range of angles is within about 70 degrees, but is not less than forty five degrees. Due to the S shaped configuration of the catheter, a precise entry of the introducer is not required.
As shown in FIG. 13, acceptable results are achieved with the S-shaped catheter used according to the novel method, even though the angle of insertion of the introducer varies from that shown in FIG. 10. Likewise, the angle of introducer insertion may be varied as shown in FIG. 14. The introducer may be withdrawn from the position shown in FIG. 14 to the interior, posterior annular wall, and S-shaped catheter is capable of being positioned against the lateral posterior wall of the disc by the method stated above.
The catheter may provide heat or radio frequency for the purpose of treatment of the disc. Other therapeutic applications may be used with the device and method. Further, a catheter 20 may have multiple orifices for the purpose of delivering materials such as adhesives, sealants or fillers into the disc. FIG. 15. A substance 22 may be injected through the catheter to the affected site to seal chemically, or otherwise, as opposed to thermally, defects including fissures and tears in the annular wall. Pressure manometery or fibro-optical viewing are also possible uses of this catheter system.
FIG. 16 shows a second embodiment of the device, wherein the sheath has ports 32, 34 formed therein. The stylet is shown in position in the introducer of this embodiment. The stylet and introducer are used to access the interior annulus of the disc and shown in FIG. 18.
After entry into the disc, the stylet is withdrawn. The ports of the sheath may be used to insert materials into the disc, or remove materials from the disc. A vacuum may be applied to the ports for the purpose of removal of material.
FIG. 19 shows a flexible deformable tip of the sheath. Deformation of the tip, which may be visualized fluoroscopically, defines hitting the inner annular wall. In one embodiment, 0.5 centimeters is sufficient protrusion of the sheath, such that it can be observed to bend when it contacts opposite inner annular wall. The bending of the tip of the sheath defines the limit of the inner annular wall immediately across from the entrance of the introducer complex into the disc. The limit of the inner annular wall opposite to the introducer insertion may be defined when fluoroscopically viewed.
As shown in FIG. 17, a rotary cutter 36 is contained within the sheath. The rotary cutter is used to cut away material as the introducer is withdrawn. FIG. 21. Alternately, another type of cutter may be used.
When the introducer, sheath and cutter complex are in the nucleus, the tip of the flexible sheath is advanced by external manipulation such that it protrudes from the introducer. The threaded probe protrudes from the sheath, such as by 2-3 mm. The rotating threaded probe is activated to rotate within the inner annular wall. The initial “pass” of the rotating threaded probe is accomplished by withdrawing the introducer/sheath/probe linearly back to the position where the introducer/sheath tip is at the level of the opening into the inner annular wall as previously defined. The complex is then advanced back to its position at the opposite inner annular wall as previously defined fluoroscopically. The sheath/probe is kept in its current position while the introducer is withdrawn a pre-defined distance, such as 5 mm in one embodiment. The complex is again withdrawn with probe rotating. An additional amount of material is removed, similarly to mowing a lawn. If an additional amount of material is present between the first and second probe withdrawals, the amount of withdrawal can be modified to be less than, for example, 5 mm. In successive fashion, the complex is advanced, the introducer 40 withdrawn, the rotation of the treaded probe is started, the sheath/probe, and then the introducer segment, is withdrawn until the final sheath/probe withdrawal is accomplished with the introducer tip at the level of the insertional inner annular wall. Since the sheath is S shaped, short lengths of sheath protruded from the introducer will be arcuate. Incrementally longer segments of exposed sheath assume varying degrees of the S shape. This process very thoroughly evacuates the approximately half of the nucleus that is initially addressed. At this point, the sheath/probe is withdrawn into the introducer. The sheath/probe is rotated substantially 180 degrees within the introducer. The process is then repeated in the same fashion on the opposite half of the nucleus. Infusion of a substance, which could be normal saline, via a side portal 32 into the sheath, alternating with suction at portal 34, may be performed at intervals to facilitate removal of the nuclear contents.
The sheath has a pre-formed S shape, and a memory for the S shape. Accordingly, as the rotary cutter is extended from the introducer, the sheath will continue to curve slightly, which allows material 42 which is adjacent to the cut taken in FIG. 21 to be removed. FIG. 22. As the rotary cutter cuts material away, lavage/suction are applied through the ports 34 of the introducer. One port allows for infusion of a substance (which may be normal saline) into one port. The other port is for suction or other form of removal of material including debris from the disc. By increasing the length of the S-shaped sheath from the introducer 40, additional passes each take material from the disc, as the cutter is further extended from the sheath. FIG. 23 demonstrates the cutter after the cutter has made six passes, and is beginning a seventh pass. In each pass, the arcuate shape of the sheath as it is extended which allows for progressively removing from the interior of the disc. Shorter segments of the sheath exposed from the introducer have an arcuate shape allowing for an infinite number of paths throughout the disc enabling the removal of nuclear material if needed.
After the material is removed from one side of the disc, the cutter is retracted into the introducer. The cutter and/or the sheath are rotated 180 degrees, so that the S shaped cutter is present on the opposite side of the disc. The sheath containing the cutter is extended from the introducer on each subsequent pass as needed, until material is removed as desired from the disc as shown in FIG. 24.
FIG. 25 shows a trocar 50 that is a present within an introducer 52. The trocar may be a relatively large stylet. FIG. 26 shows a retractor 54 that is present within the introducer. The retractor manipulates the nerve root 56.
FIG. 27 shows a vertebra 58 of a mammalian spine, an additional vertebra 60 of a mammalian spine, with an intervertebral disc 62 between the vertebrae. Also shown are a pedicle 64, a superior articular facet 68 and an inferior articular facet 66. The nerve root 56 is shown as traversing the intervertebral disc. As shown, the position of the nerve root interferes with access to the intervertebral disc. FIG. 27 is an oblique view demonstrating what is typically visualized flouriscopically for intradiscal procedures, except for the nerve root, which does not visualize under fluoroscopy, but whose position is known to an experienced operator.
The trocar is used to pierce and penetrate skin and other tissue. Upon reaching the nerve root, the trocar is removed and the retractor is inserted. The retractor is used to lift the nerve root over the introducer, so that the nerve root is out of the way, and does not interfere with access to the intervertebral disc. FIG. 28.
Once the retractor has repositioned the nerve root over the introducer, the retractor may be removed from the introducer, and the trocar reinserted into the introducer. With the nerve root positioned over the introducer, the nerve root will not be damaged as the trocar and introducer are inserted into the intervertebral disc. The trocar pierces the intervertebral disc for access to the disc with the introducer.
FIG. 29 demonstrates a cross section of a sheath 70 that is used to evacuate a defective disc according to the method described. The sheath has three lumens in the embodiment shown. A first lumen 72 is used as a conduit for a fiber optic cable. A second lumen 74 is provided through which a cutter is delivered to the work site within the intervertebral disc. The cutter could be a laser cutter, or a mechanical cutter, such as a rotary cutter.
A third lumen 76 is relatively larger, and provides a conduit for levage and suction. Saline or other materials may be introduced to the work site in the disc through the lumen. Tissue that is removed, along with attendant blood and other materials, may be suctioned and evacuated through lumen 76.
FIG. 30 shows the fiber optic source 78, cutter 80 and the conduit for levage and suction 82.
The introducer penetrates the wall of the disc as described above. The introducer is shown as having penetrated the lateral posterior wall of the disc 84 in FIG. 31. The sheath is positioned within the disc through the introducer. The sheath is initially positioned so that its forward end extends only slightly beyond the end of the introducer. The cutter, the fiber optic and the levage and suction are actuated, and the entire assembly, along with the introducer, are pushed to the opposite wall 86 of the disc, which in this case, is the lateral anterior portion of the disc so that the pulposa of the disc and the disc wall itself are removed, as shown in FIG. 31. Since the materially extended sheath has an S-shape when no pressure is applied to the sheath, there will be a slight curvature of the sheath as it marginally extends from the introducer. Accordingly, the cut as shown in FIG. 31 is somewhat conical in shape, rather than being straight, due to the arcuate shape of the sheath when the sheath is advanced slightly from the introducer.
The evacuation progresses outwardly. As the intervertebral disc is removed, support must be provided for the adjoining the vertebrae. FIG. 32 shows the cutter removed from the sheath, and a support member or strut 88 placed in position using insertion or placement tool. The support member or strut may be capable of inflation using, for example, saline. Accordingly, the support member or strut may be a balloon or bladder.
The sheath is progressively extended, and progressive cuts are made using the introducer to traverse generally linearly in and out of the disc. As shown in FIG. 33, progressive cuts are made until the disc and associated pulposa 90 are substantially completely removed from one side of the introducer. The cutter may be removed from the sheath as required, and the placement tool inserted for placement of the support members or struts within the intervertebral disc.
After one side of the disc is substantially removed, the sheath, and/or the introducer and sheath, are rotated 180 degrees. FIG. 35. The cutter is in position in the sheath. Additional progressive passes are made by steering and advancing the introducer and sheath, individually, or as a unit within the disc, and with the cutter in place. The sheath is progressively extended on each pass, so that the portion of the disc that is further away from the introducer is removed with each progressive pass.
The S-shape of the sheath permits the material of the disc to be removed which is offset to each side of the introducer, even though the introducer is advanced and retracted on what is generally a straight line dictated by the void formed in the disc through which the introducer passes. The S-shape of the sheath allows the cutter to reach progressively laterally as the sheath is progressively extended from the introducer. The sheath of this embodiment, and the catheter shown in FIG. 4 through FIG. 15, and the sheath shown in FIG. 23 through FIG. 24, each have an S-shape when no material pressure is applied to the catheter or sheath. The catheter or sheath in each embodiment of the invention shown herein has a memory property which returns the catheter or sheath to an S-shape when no material pressure is applied to the catheter or sheath. However, when the catheter or sheath is present within the introducer, or in the case of the catheter, within the sheath for the catheter, the S shaped element is reformed to be straight, but regains it S shape as it exits the straight lumen. The sheath is preferred to be straight, and in some embodiments, rigid when used with a S-shaped catheter or tool having memory.
Continuing with the process of this preferred embodiment as shown in the drawings, FIG. 37 demonstrates the final cutting away of the disc by slight protrusion of the sheath from the introducer. FIG. 38 uses the cutter with the cutter even more slightly extending from the introducer to remove the disc. However, in practice, it may be necessary to remove the entire intervertebral disc. It may be desirable to leave some of the intervertebral disc in place as a support, as long as the targeted defective portion of the intervertebral disc is removed by the method described herein.
Various materials may be positioned within the intervertebral disc as well as within the vertebral body using the S-shaped tool. The S-shaped tool, when used in combination with the introducer as taught herein, allows the material to be positioned about the interior wall of an intervertebral disc or a vertebral body, or within the interior of the disc or body, as desired. Materials that are useful in treatment or diagnosis of the spine may be positioned using the device and method according to the invention. Such materials include, but are not limited to, epoxies, cements, gels, balloons, artificial discs, and artificial nuclei. The materials may include biological materials, such as regenerative materials that induce re-growth of spine tissue. Regenerative materials that may be positioned in the disc or vertebral body and may include morselized bone, bone substitute, or such materials as bone morphogenic protein.
Materials may be positioned inside the disc or body by tools having a lumen that provides a conduit through which fluids, including gases, liquids, gels, and semi-solids, may be transported. Materials having elastic properties, such as balloons, may similarly be transported and inflated within the disc or vertebral body. Materials having a solid structure may be positioned by tools that allow for grasping and releasing the material, such as forceps, or the placement tool shown in the drawings. FIGS. 34 and 36. The interior of the intervertebral disc and the vertebral body may be accessed as disclosed herein, or by known methods.
In one embodiment, regenerative material is placed in the space created by evacuation of the disc. The regenerative material 89 may be positioned in conjunction with, or after, positioning of the spacers or struts 88 as described above. The regenerative material will take time to create new tissue. The spacers or struts maintain a space for the tissue. The regenerative material may be placed by the elongated tool as taught by the invention.
Material may be used to provide support for the spine where elements of the spine, such as when some or all the disc or the vertebral body has been removed, or when these elements have suffered disease or damage. Placement of material may be performed by the elongated S-shaped placement tool according to methods described herein. Such filler or support material may be regenerative material, gel, balloon material, struts, cements or other filler materials. Disc replacement devices and materials may be positioned by the elongated S-shaped placement tool. Spinal fusion processes may also be performed, with fixation devices and materials placed using the elongated S-shaped tool.
FIG. 3 shows a tool positioned at the end of the S-shaped tool 92 that is useful for placing material, such as medicaments, spacers or struts, or regenerative material. This tool may also be used for removing objects, tissue or material. In one embodiment, the tool has opposing spoons 94 or scoops that form a clam shell device. The user manipulates the opposing spoons or scoops to grasp and release material or objects. The spoons or clam shell may be manipulated from an external position by the user through an actuator traversing the elongated portion of the tool and/or the sheath that extends to the exterior of the disc 4.
FIG. 39 shows a tool positioned at the end of the S-shaped tool that is useful for cutting and removing objects, tissue or material. The tool has a blade 94 at an end of the S-shaped tool 96. The blade may have a sharp edge, or it may have fingers extend from it like a rake. The blade may be manipulated from an external position by the user through an actuator traversing the elongated portion of the tool and/or a sheath that extends to the exterior of the disc 4. Tissue 42 or other material that is harvested by the tool may be evacuated, such as by suction. The suction may be provided through the tool and/or through a sheath.
Each embodiment of the tool is preferred to comprise an elongated tool having an S-shape, whether the tool is used as a conduit, a therapeutic tool, a tissue (or object) removal tool or a placement tool. The elongated tool comprises shape memory properties, so that the tool can be formed for transport through the guide or lumen of the introducer. The elongated tool regains its S-shape upon exiting the guide or lumen of the introducer. Similarly to the tool shown in FIGS. 5 through 15, an introducer and an elongated S-shaped tool can be manipulated independently of each other to advance and retract the introducer within the disc or vertebral body, and to expose as much of the S-shaped tool as is required relative to the introducer. The elongated S-shaped tool may thereby be positioned as desired within the disc or the vertebral body. The elongated S-shaped tool allows precise positioning of the tool, and therefore precise positioning of material. The elongated S-shaped tool also allows gross positioning of material where precision placement is not required.
The procedures and processes described herein may be, and are preferred to be, performed percutaneously. The procedures and processes may be performed using stab incision or small incision techniques, or techniques wherein an incision of about 2.5 centimeters or less is used to provide access for the introducer, the sheath and/or the tool.

## Claims

1. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body, comprising the steps of:
a) forming an opening through a wall of a mammalian intervertebral disc or vertebral body;
b) advancing an introducer comprising a guide through said opening in said wall of the mammalian intervertebral disc or vertebral body;
c) engaging said guide with an elongated placement tool and advancing said elongated placement tool along said guide, wherein said elongated placement tool is formed of a shape memory material and comprises a preformed S-shape and wherein said preformed S-shape of said elongated placement tool is deformed by said guide;
d) continuing to advance said elongated placement tool along said guide until a portion of said elongated placement tool comprising said preformed S-shape exits said guide into the interior of the mammalian intervertebral disc or vertebral body, whereupon the preformed S-shape of said elongated placement tool assumes said preformed S-shape as said elongated placement tool exits said guide in the interior of the mammalian intervertebral disc or vertebral body;
e) positioning said elongated placement tool as desired within the interior of the mammalian intervertebral disc or vertebral body, wherein the elongated placement tool is selectively positioned and material is deposited at points in the interior of the mammalian intervertebral disc or vertebral body by combining selective advancement and retraction of the elongated placement tool within the interior of the mammalian intervertebral disc or vertebral body with independent selective advancement and retraction of the introducer.

2. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein the elongated placement tool comprises a lumen through which the material is transported into the interior of the mammalian intervertebral disc or vertebral body.

3. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein the elongated placement tool comprises forceps that position the material within the interior of the intervertebral disc or vertebral body.

4. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein the material transported into the interior of the mammalian intervertebral disc or vertebral body is a biological material.

5. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein the material transported into the interior of the mammalian intervertebral disc or vertebral body is a regenerative material that induces regeneration of spinal tissue.

6. A device for placing material in an interior of a mammalian intervertebral disc or vertebral body, comprising:
a) an introducer for introducing an elongated placement tool into the interior of the mammalian intervertebral disc or vertebral body, said introducer comprising a guide; and
b) an elongated placement tool formed of shape memory material and comprising a preformed S-shape, wherein said elongated placement tool engages said guide, and said elongated placement tool is transported into the interior of the mammalian intervertebral disc or vertebral body by said guide of said introducer, and said S-shape of said elongated placement tool is deformable and is deformed by said introducer as said elongated placement tool is transported along said guide, and said elongated placement tool regains its preformed S-shape upon exiting said guide of said introducer, wherein the elongated placement tool is constructed and arranged so that a distal end of the elongated placement tool is selectively positioned at different points of the mammalian intervertebral disc or vertebral body by combining selective advancement and retraction of the elongated placement tool within the interior of the mammalian intervertebral disc or vertebral body with independent selective advancement and retraction of the introducer.

7. A device for placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 6, wherein the elongated placement tool comprises a lumen through which the material is transported into the interior of the mammalian intervertebral disc or vertebral body.

8. A device for placing material in an interior of a mammalian intervertebral disc vertebral body as described in claim 6, wherein the elongated placement tool comprises forceps that position the material within the interior of the intervertebral disc or vertebral body.

9. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body, comprising the steps of:
a) forming an opening through a wall of a mammalian intervertebral disc or vertebral body;
b) advancing an introducer comprising a guide through said opening in said wall of the mammalian intervertebral disc or vertebral body;
c) engaging said guide with an elongated placement tool and advancing said elongated placement tool along said guide, wherein said elongated placement tool is formed of a shape memory material and comprises a preformed S-shape and wherein said preformed S-shape of said elongated placement tool is deformed by said guide;
d) continuing to advance said elongated placement tool along said guide until a portion of said elongated placement tool comprising said preformed S-shape exits said guide into the interior of the mammalian intervertebral disc or vertebral body, whereupon the preformed S-shape of said elongated placement tool assumes said preformed S-shape as said elongated placement tool exits said guide in the interior of the mammalian intervertebral disc or vertebral body;
e) positioning said elongated placement tool as desired within the interior of the mammalian intervertebral disc or vertebral body by advancing and retracting said elongated placement tool relative to said introducer;
f) placing material in an interior of the mammalian intervertebral disc or vertebral body; and
g) rotating the elongated placement tool relative to the introducer and performing a procedure using said elongated placement tool on a side of the mammalian intervertebral disc or vertebral body that is opposite a first side of the mammalian intervertebral disc or vertebral body upon which the procedure was performed prior to rotating said elongated placement tool.

10. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein the elongated placement tool comprises a lumen through which the material is transported into the interior of the mammalian intervertebral disc or vertebral body.

11. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein the elongated placement tool comprises forceps that position the material within the interior of the intervertebral disc or vertebral body.

12. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein the material transported into the interior of the mammalian intervertebral disc or vertebral body is a biological material.

13. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein the material transported into the interior of the mammalian intervertebral disc or vertebral body is a regenerative material that induces regeneration of spinal tissue.

14. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein, prior to placing material in said mammalian intervertebral disc or vertebral body, tissue of the mammalian intervertebral disc or vertebral body is removed by an S-shaped elongated tool that comprises a cutter.

15. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein, prior to placing material in said mammalian intervertebral disc or vertebral body, tissue of the mammalian intervertebral disc or vertebral body is removed by an S-shaped elongated tool that comprises a cutter, wherein the S-shaped elongated tool is transported to the mammalian intervertebral disc or vertebral body by an introducer, and wherein the S-shaped elongated tool is positioned relative to the mammalian intervertebral disc or vertebral body by combining selective advancement and retraction of the elongated placement tool with independent selective advancement and retraction of the introducer.

16. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein the material deposited by the elongated placement tool is a spacer.

17. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein the material deposited by the elongated placement tool comprises a first material and a second material, wherein the first material is a spacer, and the second material is a regenerative material that induces regeneration of spinal tissue.

18. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein the material deposited by the elongated placement tool comprises a first material and a second material, wherein the first material is a spacer, and the second material is a regenerative material that induces regeneration of spinal tissue, wherein the spacer is constructed and arranged to maintain a space between a first vertebral body and a second vertebral body, and wherein the regenerative material is positioned within said space.

19. A device for placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 1, wherein the elongated placement tool comprises a lumen through which the material is transported, and the lumen opens near a distal end of said elongated placement tool, wherein the material is transported into the interior of the mammalian intervertebral disc or vertebral body through the lumen, and the material is positioned in the mammalian intervertebral disc or vertebral body by selectively positioning the opening by combining selective advancement and retraction of the elongated placement tool within the interior of the mammalian intervertebral disc or vertebral body with independent selective advancement and retraction of the introducer.

20. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein, prior to placing material in said mammalian intervertebral disc or vertebral body, tissue of the mammalian intervertebral disc or vertebral body is removed by an S-shaped elongated tool that comprises a cutter.

21. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein, prior to placing material in said mammalian intervertebral disc or vertebral body, tissue of the mammalian intervertebral disc or vertebral body is removed by an S-shaped elongated tool that comprises a cutter, wherein the S-shaped elongated tool is transported to the mammalian intervertebral disc or vertebral body by an introducer, and wherein the S-shaped elongated tool is positioned relative to the mammalian intervertebral disc or vertebral body by combining selective advancement and retraction of the elongated placement tool with independent selective advancement and retraction of the introducer.

22. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein the material deposited by the elongated placement tool is a spacer.

23. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein the material deposited by the elongated placement tool comprises a first material and a second material, wherein the first material is a spacer, and the second material is a regenerative material that induces regeneration of spinal tissue.

24. A method of placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein the material deposited by the elongated placement tool comprises a first material and a second material, wherein the first material is a spacer, and the second material is a regenerative material that induces regeneration of spinal tissue, wherein the spacer is constructed and arranged to maintain a space between a first vertebral body and a second vertebral body, and wherein the regenerative material is positioned within said space.

25. A device for placing material in an interior of a mammalian intervertebral disc or vertebral body as described in claim 9, wherein the elongated placement tool comprises a lumen through which the material is transported, and the lumen opens near a distal end of said elongated placement tool, wherein the material is transported into the interior of the mammalian intervertebral disc or vertebral body through the lumen, and the material is positioned in the mammalian intervertebral disc or vertebral body by selectively positioning the opening by combining selective advancement and retraction of the elongated placement tool within the interior of the mammalian intervertebral disc or vertebral body with independent selective advancement and retraction of the introducer.