AU2005202085A1 - Bone cutting device having a cutting end with a non-extending centre - Google Patents

Description

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AUSTRALIA

Patents Act COMPLETE SPECIFICATION

(ORIGINAL)

Class Int. Class Application Number: Lodged: Complete Specification Lodged: Accepted: Published: Priority Related Art: Name of Applicant: Karlin Technology, Inc.

Actual Inventor(s): Gary Karlin Michelson Address for Service and Correspondence: PHILLIPS ORMONDE FITZPATRICK Patent and Trade Mark Attorneys 367 Collins Street Melbourne 3000 AUSTRALIA Invention Title: BONE CUTTING DEVICE HAVING A CUTTING END WITH A NON-EXTENDING CENTRE Our Ref: 745359 POF Code: 372401/459955 The following statement is a full description of this invention, including the best method of performing it known to applicant(s): -1- 60 0 6q NBone Cutting Device Having a Cutting End With a Non-Extending Centre This application is a divisional application of Australian patent application 2003203728, which is a divisional application of Australian patent application 00 29321/02, which is a divisional application of Australian patent 743712, which in N turn is a divisional application of Australian patent 726979. Australian patent C726979 is a divisional of Australian patent application 71399/94. The entire contents of Australian patent application 2003203728, Australian patent N application 29321/02, Australian patent 743712, Australian patent 726979 and Australian patent application 71399/94 are herein incorporated by reference.

1. Field of the Invention The present invention relates to a device for use in performing spinal surgery. In particular, it is directed to a bone cutting device having a cutting end with a non-extending center.

2. Description of the Prior Art For the purpose of achieving long term stability to a segment of injured spine, a fusion (the joining together of two or more bones via a continuous bridge of incorporated bone) may be performed. Well-known to those skilled in such art is the interbody fusion wherein the disc is partially excised and bone placed within that space previously occupied by that disc material (between adjacent vertebrae) for the purpose of restoring a more normal spatial relationship, and to provide for stability; short term by mechanical support, and long term by the permanent cross bonding of bone from vertebra to vertebra.

For fusion to occur within the disc space, it is necessary to prepare the vertebrae to be fused by breaking through, or cutting into, the hardened outside plates of bone (the endplates) to allow the interposed bone graft to come into direct contact with the more vascular cancellous (spongy) bone, and to thereby trick the body into attempting to heal this induced, but controlled, "fracturing" by 2 both bone production and the healing of the grafts to both opposed vertebral csurfaces such that they become one continuous segment of bone.

The purpose of the present invention is to provide apparatus for use in spinal surgery. In this surgery an implant is inserted within the intervertebral S 5 space left after the removal of the disc material and permanently eliminates all motion at that location. The implant can be space occupying within the disc I interspace, rigid, self-stabilizing to resist dislodgement, stabilizing to the 00 adjacent spinal vertebrae to eliminate local motion, and able to intrinsically 0 participate in a vertebra to vertebra bony fusion so as to assure the permanency of the result.

0 At present, following the removal of a damaged disc, either bone or nothing is placed into the remaining space. Placing nothing into this space allows the space to collapse which may result in damage to the nerves; or the space may fill with scar tissue and eventually lead to a reherniation. The use of bone to fill the space is less than optimal in that bone obtained from the patient requires additional surgery and is of limited availability in its most useful form, and if obtained elsewhere, lacks living bone cells, carries a significant risk of infection, and is also limited in supply as it is usually obtained from accident victims. Furthermore, regardless of the source of the bone, it is only marginal structurally and lacks a means to either stabilize itself against dislodgement, or to stabilize the adjacent vertebrae.

An area of related prior art to be considered is that of devices designed to be placed within the vertebral interspace following the removal of a damaged disc, and seeking to eliminate further motion at that location.

Such a device is contained in Patent No. 4,501,269 issued to BAGBY which describes an implantable device and limited instrumentation. The method employed is as follows: a hole is bored transversely across the joint and a hollow metal basket of larger diameter than the hole is then pounded into the hole and then the hollow metal basket is filled with the bone debris generated by the drilling.

The present application is related to Australian patent application 29321/02 (hereinafter referred to as "23921/02"). 29321/02 describes methods of inserting artificial fusion implants between the intervertebral space left 3 remaining after the removal of a damaged spinal disc and apparatus for use in Ssuch methods.

BRIEF SUMMARY OF 29321/02 IN 5 In one aspect 29321/02 is directed to a method for inserting a spinal implant between two adjacent vertebrae, the method including the steps of:

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oo 00 inserting a spinal distractor into a disc space between the two adjacent C)vertebrae; positioning a guard over said spinal distractor and into contact with the two adjacent vertebrae; forming, through said guard, an opening across the disc space; and inserting said implant into the opening.

In another aspect 29321/02 is directed to a method for securing a hollow tubular sleeve to two adjacent vertebrae including: inserting a spinal distractor in the disc space on one side of the vertebrae, said distractor having a flat shoulder portion abutting the vertebrae; placing said hollow tubular sleeve having on one end engagement means for engaging two adjacent vertebrae and a circumferentially enlarged tubular back end, said back end having a raised crown portion, said sleeve being placed over said distractor, said distractor serving as a centering post and as an alignment rod for said outer sleeve; engaging a driver cap to said back end, said driver cap having a closed rear surface on one end and a circular front opening at the other end, said driver cap defining a first large recess within said circular opening for engaging the tubular back end of said outer sleeve and a second smaller recess for engaging said crown portion forming an internal shoulder u umanrPoMrulls~rol ~la~o~ 4 between said first and second recesses; applying an impaction force with an impacting means to said driver cap whereby said force is transmitted via said internal shoulder to said outer IN 5 sleeve until said crown is seated within said second recess; Sremoving said driver cap from said back end; and oo Sremoving said distractor with a distractor pulling means leaving said outer 10 sleeve in place.

In another aspect 29321/02 is directed to a method for securing a guard to two adjacent vertebrae of a spine, the method including the steps of: inserting at least one spinal distractor into a disc space intermediate the two adjacent vertebrae; placing said guard over said distractor; positioning one end of said guard in contact with the spine; and removing said distractor from said guard.

In another aspect 29321/02 is directed to a method for securing a guard to two adjacent vertebrae of a spine, the method including the steps of: inserting at least one alignment rod into a disc space intermediate the two adjacent vertebrae; placing said guard over said rod, said rod serving to centre and align said guard; positioning one end of said guard in contact with the spine; and ulMnarwR~nur~l~~ ,ol Iaaar I 0removing said rod from said guard.

In another aspect 29321/02 is directed to a method for inserting a spinal implant between two adjacent vertebra including: inserting a spinal distractor in the disc on one side of the spinal column to Sprovide for proper spacing of the disc space between the vertebra; oO inserting over the spinal distractor a hollow tubular member having 10 engagement means for engaging two adjacent vertebrae into the C)vertebrae; passing a trephine through the tubular member and over the spinal distractor to drill a hole in the disc and a portion of the two adjacent vertebrae; removing the trephine; inserting an implant in the vertebrae through the tubular member; and removing said tubular member.

Other aspects of 29321/02 include the implantation of a series of artificial implants, the purpose of which is to participate in, and directly cause bone fusion across an intervertebral space following the excision of a damaged disc.

Such implants are structurally load bearing devices, stronger than bone, capable of withstanding the substantial forces generated within the spinal interspace. The devices of 29321/02 have a plurality of macro sized cells and openings, which can be loaded with fusion promoting materials, such as autogenous bone, for the purpose of materially influencing the adjacent vertebrae to perform a bony bond to the implants and to each other. The implant casing may be surface textured or otherwise treated by any of a number of known technologies to achieve a bone ingrowth surface" to further enhance the stability of the implant and to expedite the fusion.

The devices of 29321/02 are configured and designed so as to promote uurnarH~oM rl ~l~llol Il~ora 1 6 stability within the vertebral interspace and to resist being dislodged, and Sfurthermore, to stabilise the adjacent spinal segments.

Another aspect of 29321/02 provides a method for Interbody Spinal Fusion utilising novel instrumentation, whereby a protective tubular member is placed prior to the drilling part of the procedure and is left in place until the graft is fully seated.

0 The apparatus and method of 29321/02 for preparing the vertebrae for oo Sinsertion of the implant allows for the rapid and safe removal of the disc, Spreparation of the vertebrae, performance of the fusion, and internal stabilisation of the spinal segment.

N In summary then, the various aspects of 29321/02, provides for a single surgery providing for an integrated discectomy, fusion, and interbody internal spinal fixation.

BRIEF SUMMARY OF THE PRESENT INVENTION This application is directed to a bone removal device for use in performing spinal surgery is described in 29321/02 and which can be used in a step of the surgical procedures described in 29321/02.

In one aspect, the present invention is directed to a bone removal device for use in performing spinal surgery for forming an opening in the spine, said bone removal device including a shaft having a longitudinal axis and terminating in a cutting end for removing bone, said cutting end having end surfaces perpendicular to the longitudinal axis and having a center which does not extend further than the rest of said cutting end, said shaft having a proximal end opposite said cutting end, said end surfaces of said cutting end and said shaft having cutting flutes over at least a portion of a length of said shaft.

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OBJECTS OF TU pESENT INVENT It is an object of the present invention to provide o improved surgical instrumentation to facilitate the performance of the combined discectomy, fusion and internal spinal stabilisation.

It is an object of the present invention to provide instrumentation that can be used in a method of spinal interbody arthrodesis that is faster, safer and more efficacious than prior methods and dan effectively be performed in the cervical, thoracic and lumbar spine anteriorly, as well as in the lower lumbar spine posteriorly.

These and other objects of the present invention will be apparent from review of the following specification and the accompanying drawings which illustrate and describe preferred embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS Fiaure 1 is a side view of the Long Distractor of 29321/02 inserted into the intervertebral space.

Figure 2 is a side view of a Convertible Distractor assembly in relation to the spine.

Figure 3 is a perspective view of a high retention Short Distractor of Figure 2.

S Figure 3A is a side view of the high retention Short Distractor of Figure 2.

n Figure 3B is a side view of an alternative Short 00 o 5 Distractor with circumferential forward facing ratcheting.

Cl SFigure 3C is a top view of the alternative Short SnDistractor of Figure 3B.

SFigure 3D is a perspective view of an alternative embodiment of a Short Distractor.

Figure 3E is a top view of the alternative distractor of Figure 3D.

Figure 3F is a side view of a further alternative rectangularized Short Distractor with knurled surfaces.

Figure 4 is a perspective view of a spinal segment (two vertebrae and an interposed disc) with a Short Distractor in place, with a portion of the upper vertebrae and disc cut away to show the Short Distractor on one side of the spine and the Long Distractor about to be placed contralaterally.

Figure 5,shows a side view of the Outer Sleeve in place over the Long. Distractor, and about to receive the Driver Cap in preparation for being seated.

Figure 6 shows the Long Distractor, Outer Sleeve, and Driver Cap following the proper seating of the Outer- Sleeve into the two adjacent vertebrae.

Figure 7A is a side view of the cervical Outer Sleeve being placed over a Long Distractor which is in place within the disc space anteriorly.

y Figure 7B is a bottom view of the single Outer Sleeve of Figure 7A.

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Figure 7C is a bottom view of a Dual Outer Sleeve.

00 OO 5 Figure 7D is an enlarged side view of the c N proximal portion of Figure 7C.

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I Figure 7E is a bottom vi'ew of a Dual Driver Cap Sfor driving two distractors.

Figure 7F is a side sectional view showing the Dual Outer Sleeve of Figures 7C and 7D, Distractors and Dual Cap of Figure 7E seated.

Figure 8 is a side view of the Outer Sleeve of Figure 7A centered on the Long Distractor and fully seated on the anterior aspect of the cervical spine.

Figure 9 is a perspective view of the Distractor Puller.

Figure 10 is a cutaway partial side view of the Proximal Puller engaging the extraction ring of the Long Distractor over the end of the Outer Sleeve.

Figure 1OA is a side view of the Puller coupled to the Long Distractor just prior to its extraction.

Figure 10B is a posterior view of the proximal Outer Sleeve and a Short Distractor in place in regard to the vertebrae, disc and nerves.

Figure 11A is a side sectional view of a bone removal device of this invention. The figure shows the Drill and Inner Sleeve within the Outer Sleeve and drilling across the intervertebral space and cutting partially cylindrical arcs from the adjacent vertebrae.

Figure 11 B is a sectional side view of preparation of the Iintervertebral space by the alternative "Trephine Method" showing the Distractor, Trephine, Inner Sleeve and Outer Sleeve in place.

0 Figure 11 C is a sectional side view as in Figure 11A, oo but showing the use of a combined distractor and bone removal device. In this device the extended proximal portion is both distracting A and self-centring.

Figure 11D is a side view of an instrument for removing arcs of bone from vertebrae following drilling.

Figure 12 is a perspective view'of the surgical Tap.

Figure 13 is a side view of the Outer Sleeve and the surgical Tap fully threaded within the interspace.

Figure 14A is a side view of the bone harvesting Trephine and motor adapter.

Figure 14B is a perspective view of an apparatus for loading a spinal implant with fusion promoting material which is another aspect of the present invention. The device shown in figure 14B is an implant Bone Loading Device.

Figure 14C is a perspective view of the Corkscrew bone freeing and extracting instrument.

Figure 15 is a partial perspective view of the Bone Loading Device in operation.

Figure 16 is a perspective view of the Implant Driver about to engage the spinal implant.

Figure 17 is a side view of the spinal implant being fully seated within the intervertebral space by means of the Driver apparatus in place within the Outer Sleeve.

Figure 18 is a side view of the lumbar spine showing the end result of the device implantation via the posterior route.

1 Detailed Description of the Drawings A.nd 0 0 Detailed Description of Method of Insertion The following is a detailed discussion of the preferred method of N performing spinal surgery which is described and claimed in §29321/02. The apparatus of the present invention can be used as part of this method. This explanation is provided as it assists in understanding the workings and features of this apparatus of this application.

The following discussion will be in regard to application in the lumbar spine via the posterior approach.

In its simplest form, the method involves the following steps. The patient is placed on a spinal surgery frame, which allows for the distraction and alignment of the disc .0 space to be fused.. A bilateral posterior erxposure of the interspace, with or 'without oartial discectomy is then performed. Utilizing distractors the disc space is distracted, and a hollow Outer Sleeve is fitted over one of the distractors. The end of the Outer Sleeve has teeth for engaging the two adjacent vertebrae.. The Outer Sleeve is driven into the vertebrae and the distractor is then removed. A hollow Inner Sleeve is then inserted into the Outer Sleeve and a stopped Drill is utilized to prepare the opposed vertebral surfaces. The Drill and the Inner Sleeve are removed as a single unit. The space is tapped if so reqruired. The prepared spinal implant is then inserted via the Outer Sleeve utilizing a stopped inserter. The instruments are then re-oved ,i nd -the procedure repeatcd on the contralateral si.d. of the spine.

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SDetailed Description Step la. Prior to surgery, translucent implant 00 toeplates appropriately adjusted for scale are superimposed on AP, lateral, and axial images of the interspace to be fused, for the -purpose of selecting the optimal implant size and to determine the desired distraction.

Step lb. The patient is preferably placed onto a spinal surgery frame capable of inducing both distraction and vertebral alignment.

Step 2. In the preferred embodiment, a standard bilateral (partial) discectomy is performed and any posterior lipping of the vertebral bodies adjacent the interspace is removed. Alternatively, no disc material need be removed. In the preferred embodiment, the interspace is exposed by performing bilateral paired semihemilaminotomies and resecting the inner aspects of the facet joints adjacent the spinal canal while preserving the supra and intersoinous ligaments.

Steo 3. Beginning on the first side, the dural sac and traversing nerve root at that level are retracted medially and a Long Distractor then inserted and impacted flush to the posterior vertebral bodies adjacent that interspace. Long Distractors with working ends of increasing diameter are then sequentially inserted until the oDtimal distraction is obtained. This optimal distraction not only restores the nornal height of the interspace, but further achieves a balance wherein the tendency for the space to collapse is resisted, which in

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urging the vertebral bodies apart is being equally resisted by the powerful soft tissue structures about the spinal Ssegment including the outer casing of the disc (the annulus C( fibrosus), various ligaments, capsular structures, as well as the muscles and other soft tissue structures. This 0 balanced distraction not only provides for the spatial C1 restoration of the height of the interspace, but for considerable stability as the space now resists further distraction or collaose.

In the preferred embodiment, as the. desired distraction is approached, the use of the solid bodied Long Distractors is terminated and a disassemblable Convertible Distractor is placed with tactile and/or radiographic confirmation of ideal distraction. The Convertible Distractor is then disassembled such that the Short Distractor Dortion is left in place and the ultra-low profile head portion being positioned adjacent to the canal.floor and safely away from the neural structures. To insure that the-Short Distractor remains in place until its removal is desired, various embodiments of the Short Distractor are available with varying degrees of resistance to dislodgment. In the preferred embodiment of the procedure, attention is then directed to the contralateral side of the spine.

Step 4. On the contralateral side of the same interspace the Long Distractor having at its working end the diameter matching the Short Distractor already in place, is then inser-ed. If ho.wever, due to an 14 O) asymetrical collapse of the interspace it is then determined that greater distraction is required on the in second side to achieve the optimal stability, then the 00 appropriate Short Distractor would be placed on the second side. Then the Short Distractor would be removed from the first side and replaced with a larger Long Distractor so as q to bring the interspace into balance.

In an alternative embodiment, the entire procedure is performed on the one side of the spine utilizing only the Long Distractor prior to repeating the procedure on the contralateral side of the spine. While this method can :be performed in accordance with the remaining steps as described in the preferred embodiment, when utilized it is best performed using a Trephine which allows the Long Distractor to remain in place, thereby allowing for interspace distraction otherwise provided in the first method by the Short Distractor. This alternative method then requires the use of a Trephine over the Long Distractor in lieu of a reamer and is therefore called the "Trephine Method", which will be discussed in detail later.

Step 5. With the Short Distractor in place on the first side of the spine, and the matching Long Distractor in place on the second side of the spine, and with the dural sac and traversing nerve root safely retracted, the Outer Sleeve is placed over the Long Distractor and firmly impacted to its optimal depth using the Impaction Cap and a mallet. The Long Distractor is then removed.

Step 6. An Inner Sleeve is then placed within Sthe Outer Sleeve, and the interspace is then prepared on Di Enlmill, Reamer, or that side by utilizing a Drill, End-ill, Re or Trephine to drill, ream, or cut out the bon to be removed 00maining interposed discal O 5 to either side, as well as any ining intrposd discal Smaterial. in the preferred method, utilizing a specially designed Endmill-Drill, it and the Inner Sleeve are removed C as a unit, safely carrying, away the bone and disc debris trapped within them from the spinal canal.

S Step 7. If required, a thread forming Tap with penetration limiting means to control the depth of insertion, is then inserted through the Outer Sleeve.

Step 8. The prepared implant is then inserted utilizing the specialized Driver unit. It should be noted that the implant may be coated with, made of, and/or loaded with substances consistent with bony fusion. However, in the preferred embodiment, the implant is treated with bone promoting and inducing substances,- but is loaded with materials suitable for participating in a fusion.

While substances both natural and artificial are covered by the present invention, the preferred embodiment is in regard to the use of the patient's own bone by the following method. A hollow Trephine.is utilized to harvest a core of bone from the posterior superior aspect of the iliac crest adjacent the sacroiliac joint. This core of bone is at its outside diameter, slightly smaller than the inside diameter of the spinal implant to be loaded, but longer than the spinal implant. Utilizing an instrument O16 designed for that purpose, the core of bone is then in injected from within the Trephine into the central cavity 00 e bone of- the implant causing a superabundance of the bone Smaterial within the implant such that the bone material tends to press out through the openings conmmunicating with the outside surface of the implant.

Step 9. Using the Driver Extractor instrument, the prepared implant is threaded into the prepared interspace. The instrumentation is removed from that side of the spine and attention is then redirected to the first side of the spine. A small retractor is utilized to move the dural sac and traversing nerve root medially and to orotect them and allowing the direct visualization of the retained Short Distractor unit. Without removing the Short Distractor, it is reassembled to its shaft portion, essentially reconstituting itself into a Long Distractor.

With the inserted implant now acting as the distractor on the opposite side, the Long Distractor is utilized to guide the Outer Sleeve dow-n where it is impacted as described in Step Steps 6 7 are then repeated, completing the procedure at that level. The wound is then irrigated and.

closed in the routine manner.

Reoresentative Eamole of The referred Method Through preoperative templating of the patient's anterior posterior, lateral, and axially imaged M scan in conjunction with translucent overlays of the various sized 17 implants, the correct implant diameter and length are accurately assessed, as well as the correct amount of 00 distraction needed to restore the interspace to its Spremorbid height. The patient is then properly positioned and a bilateral partial discectomy performed via paired semihemilazinotomies.

For the purpose of this example, it will be assumed that by preoperative assessment it was determined that the correct implant would have an external diameter of 18mm and be 26mm long. -Further, the distraction necessary to restore the height of the interspace would be approximately O1mm. The dural sac and traversing nerve root would then be retracted medially and protected, while a Long Distractor having an outside diameter to the barrel portion corresponding to the implant to be inserted, that is 18mm, and having a diameter at the working 'end of perhaps 8mm, would be inserted. This then being found to be slightly smaller than optimal by direct observation, a Convertible Distractor having in its barrel portion an 13.

outside diameter, but.having in its working portion a diameter would then be inserted. Direct observation and/or x-ray then confirming the ideal distraction, the Convertible Distractor would then be disassembled, the barrel and head portion removed, and the Short Distractor portion left deeply embedded and with its flanged head flat against the canal floor and deep to the neural structures.

It would then be safe to allow the dural sac and nerve root to return to their noal] positions, .,,hich would be 4 ,18 superficial to the flanged portion of the Short Distractor.

SAttention would then be .directed to the.

C contralateral side. The dural sac and nerve root would Sthen be retracted medially on this second side, and a Long Distractor with.an 18mm diameter barrel portion and a working portion would then be inserted into the interspace and driven flush to the bone if necessary, such impaction imploding any osteophytes not already removed, and assuring that the shoulder portion of the barrel comes to lie flat against the posterior aspects of the adjacent bodies. With the dural sac and nerve root still safely retracted, the outer Sleeve would then be placed over the Long Distractor and utilizing the Driver Cap and a mallet, seated to the optimal depth.

In the preferred embodiment, the Long Distractor is then removed and the Inner Sleeve is inserted into the Outer Sleeve. Since the purpose of the Inner Sleeve is to support the drill and allow for the increased size of the implant over the size of the drill, thus making it possible for the insertion of the implant to occur through the Outer Sleeve, the Inner Sleeve therefore measures 18mm in its outside diameter, and 16.6mm in its inside diameter. This allows it to fit within the Outer Sleeve, the diameter of which is 18.1 mm and to admit the drill bit which is 16.5nmm in diameter.

Following the drilling procedure, the Drill and Inner Sleeve are removed as a sincle unit with the trapped S19 interposed cartilaginous and bony debris. The depth of drill penetration is preset and limited by the fixed rigid OO column of the Outer Sleeve. In this example, the space (c will be prepared to a depth of 28mm in anticipation of countersinking a 26mm long implant at least 2mm. If a Tap S"were to be utilized, it would be inserted at this time and be appropriate to the minor and major diameters of the implant to be inserted and as with the Drill, controlled for its depth of penetration. The spinal implant would then be prepared for implantation by utilizing a Trephine to harvest a core of posterior iliac bone greater than 30 m-n long and approximately 14.5mm in diameter.

Using the Bone Loading Device, this core of bone would be forcefully injected into the internal chamber of the spinal implant which would then be capped. Cap end forward, the fully loaded implant would then be attached to the Insertion Driver, down the Outer Sleeve and screwed into place with the depth of penetration limited by the Insertion instrument. The Insertion Driver is then unscrewed from the implant and removed from the Outer Sleeve. With the dural. sac and ner-e root retracted and protected, the Outer Sleeve would then be removed. This would complete the'fusion procedure on that side, and then as described, the procedure would be repeated on the other (first) side of the same interspace.

i.teinative Methods An alternative and e:trecely useful method is the "Trephine !Method". Its advantages include that it may be used in conjunction with the preferred embodiment 00 substituting the use of a hollow, tubular cutter, called a STrephine for the use of the Drill in Step 5 of. the preferred embodiment. Additionally, it may be utilized so as to obviate the .need for the placement of the Short Cl Distractor and to allow the procedure to be effectively performed from start to finish on one side prior to initiating the procedure on the opposite side, and while nevertheless maintaining distraction at the site of the bone removal.

The following is a description of the "Trephine Method".

Having completed the exposure of the interspace on at least one side, the dural sac and nerve root are retracted. A Long Distractor differing from the Long Solid Bodied Distractor of the preferred embodiment only in that the barrel portion is of a precisely lesser diameter than the spinal implant. As in the preferred embodiment, the Outer Sleeve has an inner diameter only slightly greater than the implant to be inserted. Therefore, at this time, a first Irnner Sleeve is inserted into the Outer Sleeve to ma.ke up the difference between the outside diameter of the Long Distractor and the inside diameter of the Outer Sleeve.

With the. Outer Sleeve and first Inner Sleeve thus assembled, they are placed over the Long Distractor and the Outer Sleeve is optimally seated using the Impaction Cap.

The Can and first Inner Sleeve are removed, but the Long Ct 21 °O Distractor and Outer Sleeve are left in place.

With the Long Distractor maintaining optimal 0 n distraction and with the Outer Sleeve locking the vertebrae C- together so as to resist any movement, of the vertebrae, a 5 hollow, tubular cutter known as a Trephine is then inserted O over the Long Distractor and its barrel portion and within the Outer Sleeve. The Trephine, which is stopped out to the appropriate depth, can then be utilized to cut equal arcs of bone from the opposed vertebral endplates.

Alternatively, a second Inner Sleeve may be placed within the Outer Sleeve prior to placing the Trephine over the Long Distractor and within that second sleeve. This second Inner Sleeve would be just greater in its internal diaetejr than the Long Dis-tactor e-d just smaller in its outside diameter than the inner diameter of the Outer Sleeve. While it would provide enhanced stability to the Trephine, provision would then need to be made in the way of large flutes passing longitudinally or obliquely along the outer surface of the Distractor to its barrel portion to accommodate the bony and .cartilaginous debris generated during the cutting procedure.

Following the use of the Trephine to the appropriate depth by either of these methods, the Trephine, the Long Distractor, and the second Inner Sleeve, if utilized, are all removed. Since the.Trephine cuts two arcs of bone but does not ream them out, a shafted instrument with a perpendicular cutting portion at its working end is then inserted parallel to the disc space and then rotated through an arc of motion cutting the bases of the two longitudinally cut arcs, thus freeing them for OO removal through the Outer Sleeve. The space ay then be Stapped if required, and the implant is inserted as per the I 5 preferred method. As already mentioned, the "Trephine SMethod" can be used with or without the use of the Short Distractor on the contralateral side.

Aoolications of Method in Other Areas of the S-ine The following method is the preferred embodiment for performing anterior interbody fusion in the thoracic and lumbar spines. It is also appropriate in the cervical spine when the width of the spine anteriorly is sufficient so that it is possible to place two implants side by side and such that each intrudes at least several millimeters into the substance of the opposed vertebrae and for..the length of the implants.

The interspace to be fused is adequately e:-posed and the softtissues and vital structures retracted and protected to either side. Visualization of the broad width of the interspace anteriorly is made possible by the absence of the neurological structures in relation to this aspect of the spine. The center line of the anterior aspect of the interspace is noted and marked. The disc is removed using first a knife and then curettes and rongeurs as needed. Alternatively, the disc may be left intact to be removed during the drilling stage of the procedure.

However, as per the preferred embodiment of the procedure, S23

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having removed- the great mass of the nucleus and the greater portion of the annulus anteriorly, Long Distractors 00 with progressively increasing diameters to their working ends are inserted into the interspace at a point midway between the central marking line and the lateral extent of the anterior aspect of the spine as visualized.

The Dual Outer Sleeve with its common Foot Plate and Retention Prongs is then inserted over either a singly placed Long Distractor and then the second Distractor placed, or is placed over both Distractors if already placed. The Dual. Outer Sleeve is then seated firmly against the anterior aspect of the spine. A-ny spurs which would interfere with the flush seating of the Foot Plate to the anterior aspect of the spine should be removed orior to inserting the Long Distractors. Once the Outer Sleeve has been optimally seated, one of the Long Distractors is removed and in its place is inserted an Inner Sleeve and drill bit. The drill bit has as its outside diameter the minor diameter.of the imolant to be inserted. The Inner Sleeve is essentially equal in thickness to the difference between the minor and major diameters of the threaded implant.

A Stopped Drill is then utilized to prepare the opposed vertebral surfaces and to remove any remaining disc material interposed. If required, a Stopped Tap may be inserted through the Outer Sleeve and into the interspace to create a thread form. The properly prepared implant is then affi:xed to the Insertion Driver and passed through the w 24 SOuter Sleeve down into the interspace and inserted until its depth of penetration is limited by the stop on the in insertion Driver. With the implant itself now in a C position to act as a distractor, the Long Distractor is C 5 then removed from the contralateral side and the procedure repeated. When both implants are firmly in place, the Souter sleeve may then be removed. The amount of countersinking of the implants may then be adjusted under direct vision.

Detailed Descriotion of the Preferred Embodiment Method and Instrumentation In the preferred embodiment, the disc between adjacent vertebrae is approached via bilateral paired semihemilaminotomies of the adjacent vertebrae. In the preferred embodiment the supraspinous ligament, the interspinous ligament, the spinous process, portions of the lamina, and most of the facet joints are preserved.

However, while less desirable, these structures may be removed.

In the preferred method, a bilateral partial nuclear discectomy is th-en performed through bilateral openings created through the posterior aspect of the annulus fibrosus. While considered less desirable, disc excision can be delayed and performed simultaneously with the vertebral bone resection during the drilling procedure.

Starting on the first side a dural nerve root retractor is plated such that the dral sac and lower nerve root are c" IN) retracted medially allowing exposure to one side of a portion of two adjacent vertebral bodies and the interposed disc posteriorly.

00 O Referring now to Figure 1, preferably after removing some portion of nuclear disc material, a Long Distractor 100 is inserted under direct vision into the CN intervertebral space. The disc penetrating portion 102 is essentially cylindrical with a bullet-shaped front end 103 and a shoulder portion 104 where the penetrating portion 102 extends from barrel 106. The penetrating portion 102 urges the vertebral bodies apart, facilitating the introduction of the instruments. Long Distractors with sequentially increasing diameter penetrating portions 102 are then introduced. As the optimal diameter of penetrating portion 102 is achieved, the vertebral bodies to either side are forced into full congruence and thus become parallel, not only to the penetrating portion 102, but to each other. At this time, any remaining excrescences of bone of the posterior vertebral bodies adjacent the posterior disc which have not already been removed are flattened flush to the vertebral body by the forced impaction, such as by hitting with a hammer flat surface 109 of crown 110, driving the shoulder 104 against the lipped portions of vertebrae V. Because of the forced opposition of the vertebral endplates to portion 102 with optimal distraction, unit 100 will then come to lie absolutely perpendicular to the plane of- the posterior bodies and absolutely parallel to the vertebral endplates, S26 IN allowing optimal alignment for the procedure to be performed.

SPenetrating portion 102 is available in various Sdiameters, but all are of a constant length, which is less C 5 than the known depth of the interspace. This combined with 0 the circumferential shoulder 104, which is too large to fit 1 C within the interspace, protects against the danger of overpenetration. Barrel 106 is of the same diameter as the external diameter of the device to be implanted.

A

recessed portion 108 below the crown 110 allows for the Long Distractor 100 to be engaged by an extractor unit shown in Figure 9.

In the preferred embodiment, a Convertible Long Distractor 113 is used on the first side of the spine. As shown in Figures 2, the Convertible Long Distractor 113 has a barrel portion 152 separable from the Short Distractor portion. 120. While the initial distraction may be performed with a solid Long Distractor, as the optimal distraction is approached the appropriate Convertible Long Distractor is utilized. The Convertible Long Distractor 113 consists of a Short Distractor portion 120 and a barrel 152 having a rectangular projection 134 at one end. The Short Distractor 120 has an increased diameter head 128, a rectangular slot 118 and an internal threaded opening 114.

The barrel 152 is hollow and has an internal shaft 111 terminating in .a large diameter hexagonal crown 115 at one end and a reduced diameter portion 112. The crown has a detent portion 117 in its flat surface. The other end of I the shaft 111 has a threaded small member 116 that corresponds to threaded opening 114. The shaft ill is il* prevented from removal from the barrel 152 by set pin 119 00 0 passing through -the wall of barrel 152 in a convenient 0 5 manner. The Short Distractor portion 120 is removably l attached to the barrel portion 152 via the mating of female rectangular slot 118 and the male mating member 134. The mating held together by utilizing knob 136 to drive the crown 110 connected to interior shaft 111 having a threaded working end screw 116 that threads into the female aperture 118 of the Short Distractor portion 120.

Cap 136 has an open socket 138 for fitting around crown 115 and engages 'the reduced diameter hexagonal portion 112 so as to Dermit the rotation of shaft 111 and threaded male member 116. A detent ball 150 in the inside of the socket 138 engages detent 117 in the cro-wn 115, holding them together.

The Short Distractor portion 120 of Fig-ures 2, 3, and 3A-3F are designed to provide for high stability when temporarily situated so as to resist inadvertent .migration while the surgeon is working on the second side. To that end, the embodiment of the Short Distractor 120 shown in Figures 3 and 3A has a pair of sharp pegs 126, to embed into the opposing vertebral bodies and forward facing ratchetings 124, that further resist backward movement.

Figures 3B and 3C, which show the preferred embodiment, are side and top views of an alternative embodiment of the distractor portion such that the distractor portion to be 28 P- interposed between the vertebrae is essentially cylindrical, but with circumferential forward facing 00 ratchetings 124.

C' A further alternative embodiment is shown in Figures 3D and 3E. This is a more rectangularized design, Swith forward facing ratchetings, without the sharp prongs 126 of Figure 3. Figure 3F is a side view of a further embodiment of the Short Distractor 120 shown with knurling, to increase the interference with the bone surface so as to add stability to the unit and.to resist dislodgment. To this end, it is apparent that the working ends of both the Long and Short Distractors can have a variety of configurations consistent with their purpose, and that surface irregularities as well as the shape of the ends themselves, with or without prongs 126, may be utilized to make the Short Distractor 120 more resistant to migration.

Once the ideal distraction has been achieved on the first side of the spine, the Convertible Distractor is dissociated, leaving Short Distractor 120 in place with its rounded external" end 128, safely on the canal floor and deep to the dural sac and nerve root.

As shown in Figure 4, the surgeon then moves to the other side of the spine at the same disc level, and retracts the dural sac and nerve root medially,, exposing the disc on that side. Long Distractors 100 are then sequentially inserted into the disc space until the diameter of the distractor on the second side is at least as big as that on the first side. If because of some 29 asymnetry of theinterspace a larger diamter distractor is n required on the second side to. achieve the ideal 00 O distraction as compared to the first side, then the second side' is fitted with a Short Distractor of the larger diameter, and the surgeon would then return back to the C first side. In that event, the first side Short Distractor would then be removed and the Long Distractor 100 corresponding to the increased diameter of the already placed Short Distractor 120 would then be inserted. In either event, the operation is continued by working on the one side where the Long Distractor is in place. In this regard, it should be noted, that by the use of such a device as the Michelson Spinal Surgery Frame, it may be possible to obtain adequate distraction preoperatively such that the surgeon is either disinclined to use a distractor, or to simply place the correct Long Distractor on the first side and then proceed with the surgical procedure on that side before moving to the opposite side. These variations are within the scope of 29321/02.

The Long Distractor now serves as both a centering post and an alignment rod for the hollow Outer Sleeve 140 sho l .n in Figure 5 which is fitted over the Long Distractor 100, showrm by phantom lines 101 in Figure The Outer Sleeve 140 is metal and has a sharp toothed front end 142 that is capable of penetrating into and holding -ast the two adjacent vertebrae Interrupting the circuEferential sharp teeth of 142 are flat, planar areas 152 which serve to resist the further insertion of the sharp teeth into the vertebral bodies. The toothed front end 142 of the Outer Sleeve 140 is a continuation of the OO tubular shaft 144, which in turn is connected to c( circumferentially enlarged tubular back end 146 having a 5 knurled outer surface 148 for easier manipulation. An O alternative embodiment of an Outer Sleeve incorporates an C N expansile key hole and slot configuration 154 to either side of shaft 144 along the mid-plane of the interspace and parallel to it such that the end 142 resists the collapse of the vertebrae to either side of the disc but may nevertheless allow for their further distraction, in the event the only diameter or the root diameter of the implant is larger than the hole drilled.

A Driver Cap 160 in the form of an impaction cap has at its far end a flat, closed-back surface 162 and at its other end a broad, circular opening.. The Driver Cap 160 fits over both the outer Sleeve 140 and the Long Distractor 100. As the Driver Cap 160 is seated, interior surface 170 circumferentially engages portion 146 of the Outer Sleeve until the back end 172 engages the internal shoulder 164. As mallet blows are applied to surface 162, that force is transmitted via the internal shoulder 164 to the Outer Sleeve 140 via its far end 172, seating teeth 142 into the vertebral bodies adjacent the disc space D and to the depth of the teeth 142 to the flat portions 152. As the Outer Sleeve 140 is advanced forward, crown portion 110 of the Long Distractor is allowed to protrude within the Driver Can 160 unobstructed until it contacts the interior I flat surface 168. Once crown 110 comes into contact with the flat interior surface 168, then further taps of the 0 mallet will not advance the Outer Sleeve, any further 00 m notion being resisted by the flat shoulder portion 104 of 5 the Long Distractor abutting the hard surfaces of the 0 posterior vertebral bodies. In this way, the Outer Sleeve C 140 is safely and assuredly inserted to its optimal depth and rigidly securing the two opposed vertebrae as shown in Figure 6.

The Cap 160 is then removed and the Distractor Puller 200 of Figure 9 utilized to remove the Long Distractor 100 from the spine leaving the Outer Sleeve 140 in place. The Distractor Puller 200 has front portion 202, a mid portion 204, and a back handle portion 206. At the front portion 202 of the Distractor Puller 200, a socket 208 is connected to one end of shaft 210 which at its far end is connected to back handle portion 206. The socket 208 has defined within it a cavity 212 that is ope-n at its front end and furnnelized on the interior aspect of its sides. The cavity 212 is constructed so that the head of the Distractor Puller 200 and the partially circumferential flange 218 engages the circumferential recess 108 of the Distractor 100. The entrance to cavity 212 is slightly funnelized, and the leading edges of flange 21S slightly rounded to facilitate the engagement of recess 108 and head 110 of Distractor 100, which is further facilitated in that the Driver Cap 160 -leaves portion 108 of Distractor 100 precisely flush with t.he back surface 172 of the Outer w 32 IND Sleeve 10O. This provides a large, flat surface 172 to precisely guide surface 230 of socket 208, and open portion in 212 around head 110 while flange 218 engages recess 108.

00 0 The springloaded detent ball 228 engages hemispherical depression 112 in the crown 110, shown in Figure 2. This springloaded detent 228 in engagement with complimentary C- indent 218 protects against the inadvertent dissociation of the Long Distractor from the Puller 200 after the Distractor has been removed from within the Outer Sleeve 140 and prior to its removal from the wound. Once out of -the body, the two instruments are easily disassociated by freeing the crown portion 110 from cavity 212 by a manual force applied perpendicular to their relative long axes at this location.

A cylindrical and free removable weight 216 is fitted around shaft 210 between the front portion 202 and the rear handle. portion 206. Gently, but repeatedly sliding the weight 216 along shaft 210 and driven rearwardly against flat surface 228, transmits a rearvard vector to proximal end 202 and thereby to the Long Distractor 100 to which it is engaged.

Paired extended handle 224 and 226, allow the surgeon to resist any excessive rearward motion as the instrument is used to liberate the Long Distractor 100.

Paired handles 224 and 226 are also useful in that they allow a rotational directing of portion 208, via the shaft 210. This allows the surgeon to control and manipulate rotationally the orientation of the opening of cavity 212

I

o he h ead 110 of une to facilitate its appication to te 10 of the distractor 100.

OO The Distractor Puller 200 is a significant C improvement over the alternatives of striking a remover instrument with an independent hammer over the exposed surgical wound, or manually extracting the distractor by forcefully pulling. The use of a free hammer over the open wound is dangerous because the neural structures can be impacted on the back swing which is made even more likely by the effects of gravity on the mallet head. Manual extraction by pulling is dangerous because of the significant interference fit of portion 102 within the spine such that significant force would be required to remove the Distractor 100, and if force were not coaxial then the Outer Sleeve might be dislodged or misaligned.

Further, once the flat portion 102 became free of the interspace, all resistance to withdrawal would be lost and in the face of the considerable force necessary to free it, the Distractor 100 might easily become projectile imparting injury to the patient and/or the surgeon.

Once the Long Distractor 100 has been fully removed from the Outer Sleeve 140, the toothed end 142 of the Outer Sleeve 140,. working in conjunction with the Short Distractor 120 on the contralateral side rigidly maintains the relative position of the adjacent vertebrae

V.

Further, since the remainder of the procedure on that side of the spine occurs entirely through the protective Outer Sleeve 140, snd as the nerves and dural sac are e.:ternal to g 34

ID

that Outer Sleeve and superficial to the toothed end 142 of in the Outer Sleeve 140, which is firmly embedded into the 00es o insure O adjacent vertebrae V, the Outer leeve 140 serves to insure Sthe safety of these delicate neural structures. Further, since the Outer Sleeve 140 is of a fixed length and rigid (C its flat rearward surface 172 may be used as a stop to the advancement of all instruments placed through the Outer Sleeve 140, thus protecting against accidental overpenetration. Further, the Outer Sleeve 140 assures that the further procedure to be performed will occur coaxial to the disc space D and further, be symmetrical in regard to each of the opposed vertebral surfaces.

Figure 10B is a posterior view of the spine at this stage of the procedure, showing a Short Distractor 120 in place on one side of the spine and the bottom portion of Outer Sleeve 140 in place on the opposite side of the spine.

Referring to Figure 11A, an Inner Sleeve 242 is inserted from the rear within the Outer Sleeve 140. This Inner Sleeve has a -collar portion 2 4 4 of a known thickness which seats against the top edge surface 172 of Outer Sleeve 140. The cylindrical barrel portion of Inner Sleeve 242 comes to approximate the posterior aspect of the vertebral bodies interior the Outer Sleeve when fully seated. A Drill 240, having a known selected length is then introduced through the rear'ward aperture of the Inner Sleeve 242 and utilized to reaM out the arcs of bone which it encages from the opposed vertebral endplates as well as any discal material within its path down to its Sredetermined and limited depth. The Drill 240, has a narrow engagemet portion 246, which allows it to be O0 affixed to a drill mechanism which may be either a manual or a power unit. A circumferential collar 248 of an ^I increased diameter serves to limit the depth of penetration Sof the drill 240 and may be fixed, or lockably adjustable.

Not shown here,' but well known to those skilled in the art, are various mechanisms to lockably adjust such instruments as drills. Such mechanisms include, but are not limited to, the use of collets, threaded shafts with lock nuts, and flanges engaging grooves forced therein by either a cap pulled over the flanges or screwed down upon th em.

In one aspect according to the present invention, the forward cutting edge 252 of Drill 240 is perpendicular to the longitudinal axis of the shaft of Drill 240, the cutting edge 252 having a centre which does not extend further than the rest of the cutting edge. Also present are flutes 251 for grinding debris generated during the operation of the Drill 240 toward the proximal end of the shaft of said Drill 240.

In a preferred embodiment, the forward cutting edge 252 of Drill 240 is a modification of a large fluted drill design such that the end resembles an end cutting mill which may contain any workable number of cutting surfaces, but preferably four or more, and such cutting surfaces being relatively shallow such that the advancement of the instrument occurs more slowly. The outside diameter of the Drill 240 corresponds to the minor diameter of the threaded soinal implant. The Inner Sleeve 242 has an inner dianeter slightly greater than that dimension and its outer diameter is slightly smaller than the inside diameter of 36 the Outer Sleeve 140 which has the same outer diameter as the major diameter of the threaded implant.

The drill shaft of drill 240 comprises an upper portion 243, a central recessed portion 256 of a smaller diameter and a lower cutting drill portion 250. The upper portion 243 and lower portion 256 of the drill 240 have the same outside diameter.

The Inner 'Sleeve 242 serves many functions.

First, it provides a more intimate drill guide for drill 240 in the event a smaller diameter hole is to be drilled than that of the inside diameter of the Outer Sleeve 140.

Second, since it now guides the Drill, it allows for the Outer Sleeve 140 to have an internal diameter large enough to admit the threaded spinal implant, which is indeed considerably larger in diameter than the Drill 240 itself.

If a larger Outer Sleeve 140 were utilized absent the Irner Sleeve 242, then the Drill 240 would be free to wander within the confines of that greater space and would not reliably make parallel cuts removing equal portions of bone from the adjacent vertebrae V. Further, the bone removal not only needs to be 'equal, but must be correctly oriented in three dimensions. That is, the path of the Drill 240 must be equally centered within the disc space, parallel the endplates, and parallel to the sagittal axis dissecting the interspace.

A further purpose of the Inner Sleeve 242 is that it may be removed simultaneously with the Drill 240, thereby trapping the debris, both cartilaginous and bony generated during the drilling procedure, which are guided rearward by the large Clutes 251 of Drill portion 250, 37 where they are collected around recessed portion 256 between the recessed portion 256 and the inner wall of the N Inner Sleeve 242 are there contained therein. Thus, by removing the Drill 240 in conjunction with the Inner Sleeve 242, all of the debris generated by the reaming procedure 00 is safely removed from the spinal canal and wound area.

Further, if. the disc tissue in the area to be in reamed has been removed previously, as per the preferred Smethod, then the patient's own bone of good quality and S- 10 useful within the operation will then be contained between the Inner Sleeve 242 and the shaft portion 256. Once away from the surgical wound, this material may be used to load the spinal implant or placed deep within the interspace to Darticioate in the fusion.

Figure 11C shows a combined distractor and bone removal device As shown in Figure 11C, Drill end 250 has a disc penetrating extension extending from the cutting edge 252 for insertion into the disc space between the adjacent vertebral bodies V. In the embodiment shown in Figure 11C, disc penetrating extension is a forward projecting nipple 260, 2 o which itself is bullet-shaped in its leading aspect so as to ease its entrance into the disc space and to urge the vertebrae apart. Nipple 260 is distracting, stabilizing as it resists any tendency of the vertebrae to move together, is self-centering to the Drill portion 250 when working in conjunction with Sleeves 140 and 242, and virtually assures the symmetrical resection of bone from the opposed vertebral surfaces.

The alternative "Treohine MIethod" referred to earlier in this application, is shown in Figulre 11B. In this alternative, a Long Distractor 100 is left in place 38 after the Outer Sleeve 140 is seated. The Long Distractor 100 in this case differs from the Long Distractor of the oO preferred embodiment in that its outside diameter of the C barrel 106 is -of a smaller diameter than in the prior 5 version. This is made necessary because regardless of the Smethod, the hole to be formed corresponds to the minor diameter of the spinal implant. Trephine 270, a hollow, tubular member with sharp cutting teeth 251 at its proximal end, has a wall thickness and-since the outside diameter of S that trephine 270 must correspond to the root diameter of the implant, then the wall thickness of the trephine 270 must be allowed for by a corresponding reduction in the diameter of the Long Distractor 100.

A further modification of the Long Distractor 100 to the "Trephine Method" would use longitudinal grooves (not shown) along the barrel surface 106 for the purpose of transmitting any debris generated during the cutting orocedure, rearward. Since the cutting element is both centered and aligned by the Long Distractor, the use of the Inner Sleeve 242 is not mandatory, but may once again be useful in controlling the path of the debris. To that end, little debris is generated in the nTrephine Method" as the bony arcs are not so much being reamed out and removed as they are simply being cut into the bone where these arcs of bone are left connected at their far ends. Thus, when the Trephining Method has been completed and the Trephine 270 and Inner Sleeve 2,.2 removed, unlike in the preferred embodiment where the hole is drilled out, it remains I 39 necessary to remove both the two arcs of bone, and any interposed material. Nevertheless, this is very easily OO performed by various means, one of which is depicted in SFigure 11D.

Instrument 272 consisting of a shaft 276 attached 0 off center to the lower surface 273 handle 274. The shaft 274 terminates in a cutting arm 278. The instrument 272 is inserted through Outer Sleeve 140 where the lower surface 273 of handle 274 abuts the top 172 of the Outer Sleeve 140, both stopping downward motion of instrument 272 and precisely placing the perpendicularly cutting arm 278 of instrument 272 so that as handle portion 274 is rotated, the cutting arm 278 is also rotated, cutting the arcs of bone and liberating them from their last attachments.

These portions of bone are then removed utilizing this instrument or a long forceps, and then placed within the implants or otherwise used to participate in the fusion.

While in the preferred embodiment of the present invention the spinal implant I, is essentially self-tapping, if the bone is unusually hard it may be desirable to form the thread pattern within the interspace prior to the insertion of the implant I. To that end, as shown in Figure 12, Tap 280 has a threadcutting portion 282 connected by a shaft 286 to a handle portion 292, which has -been designed to give mechanical advantage to the rotation of the instrument for the purpose of cutting threads. The lower portion of handle 290 has a forward facing flat surface 288 too large to fit through the opening of Outer 1 O the depth of Seee 140 which thus safely -lits the In penetration of the cutting element.22. This tap 280 is further ae sae by blunt end 294 which will engage e further made sa o en 2 uncut portions of the verebral bone just prior to the 0 uncut portions of the vhis engageent of oulder 288 against surface 172. This Vi 5 engagement of shoulder Sfeature allows the surgeon to appreciate a less harsh resistance as the blunt nose 294 encounters the remaining unresected bone for the drill hole and prior to the sudden increase in resistance caused by the seating of shoulder 0 288 against top edge 172, which first resistance serves as a warning to the surgeon to discontinue the tapping procedure. Thus, the surgeon has both visual (as shoulder 288 approaches top edge.1 7 2 and tactile warnings to avoid stripping the thread form. Tap end 282 is highly specialized for its' specific purpose. Rearward to the specialized blunt tip 294 is a truncated bulletshaped area 298 whic ramps to the constant diameter intermediate 2 9 8 w h i c h ra s us the cutting ridges 296. Ramp portion 298 urges the opposed vertebral bodies apart, which motion is resisted by Outer Sleeve 140, thus progressively driving the sharp leading edges of thread forms 296 into the vertebral bodies. The 284 interrnpting the thread periodic longitudinal grooves 284 nterrpting he tread forms, hich may nber 1 to 8, but preferably 4, function to accumulate the bony material which is removed during the thread cutting process. In that regar, in the ideal embodiment, the thread cutting form is designed to compress he bone to be formed rather than to trough through i.

Further, while both the major and minor diameters of the Tap 280 may be varied, in the preferred embodiment, the In minor diameter corresponds to the minor diameter of the implant I, but the major diameter is slightly less than the 0* major diameter of the implant.

Cl n 5 With Tap 280 now removed, and Sleeve 140 still in 0 place, the surgical site is now fully prepared to receive the spinal implant I. In the preferred embodiment of the spinal implant, the implant has been enhanced by the use of, application to, and filling with fusion promoting, enhancing, and participating substances and factors. Thus, the implant may be fully prepared for insertion as provided to the operating surgeon. However, at the present time, human bone is most commonly used as the graft material of choice, with the patient's own bone being considered the best source.

Figure .14a shows a trephine 300 with an exceedingly sharp front cutting edge 302 for quickly and cleanly coring into the patient's posterior iliac crest, or any other bony tissue, and for the purpose of producing a core of bone then contained within the hollow 304 of the trephine 300. Trephine 300 has a rear portion 306 with a pair of diametrically opposed slots 310, and disposed clockwise from their longitudinally oriented rearvard facing openings so as to engage diametrically and opposing members.312 of Drive unit 308, by which trephine 300 may be attached to either a hand or power drill. It can be appreciated that engagement mechanism 312 is stable during the clockwise cutting procedure, and yet allows for the rapid disconflectIin o;7 the tocomoonents once the cutting is comoleted.

Becausa o[ the 'nigh inte r-ference between the graft' and the inn-er wall" of hollow portion 304, and the relative weakness of the cancellouS bone being harvested, 00 it is possibl-e. to remove the Trephine 300 while still Cldrilling, and to have it extract the core of bone with it.

However, in -the highly unlikYely event that the core of bone would remain fixed at its base, than with the drive imechaniso 308 removed, a corkscrew 408 shown in Fig-ure 14C is introduced though the central opening of rear portion 306 and tlxeaded down and through the core of bone within 304 and to the deoth of teeth 202. The tio 318 of the corkscrew 408, which extends substantially onl line with thre outer envelooe of the corkscrew, then cuts radially through the base of the bone core. As the handle oortion 314 of the corkscrew 4,08 abuts the'-flat, rearward surface of Porti'on 206 and it can no longer advance. As corkscrew4 408 is continued to be. turned further, it will cause the core of bone to be pulled rearvard, as in removing a cork from a wine bottle. Trephine 200 has a baxrel portion 204 continuous with sharp toothed por-tion 302 having an inner rliaeter just less than the inner di-rmter- of the sp~inal imolant I to be loaded.

23 F iguIre 14B shows one ermbod~imnent of anl apparatus for loading a spInal implant with fusion1 promnoting material. This device is identified in the figure as an Implant Bone Loading device 320.

The Treohine 2'00 withl its core of harvested bone olaced as show-n in Figure 14B, through opening 240 OC implant Bone Loading devi.ce 320, where the ba-rel port-ion 304 then DassPS through~ and is stoooed circula~r S43 flange 344. The plunger shaft 326 of instrument 320 is O then prepared for attachment by rotating knob 332 gcounterclockwise such that the plunger 372 is pulled via n the long threaded shaft portion 328 back to the base of collar 330 at its proximal end. In this position, knob 332 is considerably extended rearward from collar 330. With plunger shaft 326 in this position, the plunger head 372 is inserted into the central hollow of portion 306 of Trephine 300 as the proximal cylindrical portion of collar 330 then follows it, such that the plunger 372 then occupies the rearward portion of barrel 304 and the proximal cylindrical portion of collar 330 occupies the central hollow of nortion 306. A pair of diametrically opposed, radially projecting ar .s 346 on collar 330 are then advanced longitudinally into diametrically opposed paired L slots 340 and then rotated clockwise to complete this assembly.

At the other end of instrument 320, a spinal implant I is engaged through its female rectangular slot 364 by a rectangular protruding bar extending from rearward facing surface of end plug 324, (not shown) and secured there by knob 334 which extends as a rod through a central aperture within end plug 324 to extend at the far end as. a small bolt which threads to a female aperture centered within the female slot 364 of the spinal implant. With the spinal implant I secured to end plug 324 and the opposite end of the implant I presenting as a hollow, tubular opening, end plug 324' is advanced into device 320 where it NO 44 .is secured by rotationally engagng diaetrically opposed I L-shaped slots 321. ith device 320 fully assembled, end S302 of trephine 300 lies coaxial and opposed to th open end of implant

I.

As shown in Figure 15, as knob 332 is then rotated clockwise, the plunger 372 proximal the threaded shaft 328 is then forcibly, but controllably driven forward down the barrel 304 ejecting the bone graft directly into the spinal implant I. As the bone graft is greater in length than the interior of the spinal implant, with further compression the bone is forced into the radially disposed apertures through the wall of the device communicating from the central cavity to the exterior.

End plug 324 is then removed from apparatus 320.

Using end plug 324 as a handle, end cap 374 shown in Figure 16 is secured to the open end of the spinal implant The implant is then disassociated from end plug 324 by rotating knob 334 coulnterclockwise.

Fig-ure 16 shows an Implant Driver instrument which may be used to either insert or to remove said.

implant I. Driver 350 has at its far end 362, a rectangular protrusion 398, which protrusion intimately engages the complimentary rectangular slot 364 of implant I. Protruding from slot 398 of end 362 is threaded portion 353, which extends as a rod through hollow shaft 358 and hollow hand barrel 360 to 1unob 354 where it can be rotationally controlled. TUhreaded portion 353 screws into a female aperture central slot 36~ urging 353 into 364, and binding them together such that instrument 350 can be 00 rotated via paired and diametrically opposed extending arms 366 and in either direction while maintaining contact with C the implant.

0 5 Affixed to the Driver 350, the implant is then

C

introduced through the outer Sleeve 140 and screwed into the interspace opposed between the two prepared vertebrae V until such time as the leading edge of the Implant Cap 374 reaches the depth of the prepared hole at which. time its forward motion is impeded by the bone lying before it which had not been drilled out. This allows for a progressive feel to the surgeon as the implant is screwed home.

As described previously, with the use of the Tap 280, this terminal resistance to further seating provides significant tactile feedback to the surgeon. Again, as with the Tao 280, visual monitoring of the depth of insert'ion of the implant is provided to the surgeon by observing the progressive approximation of the forward surface 370, of barrel portion 360, as it approaches the rearward facing surface 172 of Outer Sleeve 140.

Nevertheless, a final safety mechanism, when the full depth of insertion has been achieved, surface 370 of instrument 350 will abut surface 172 of the Outer Sleeve 140, prohibiting any further installation of the spinal implant.

Once the implant has been fully installed, the Driver 350 is dissociated -from the implant by turning knob 354 in a counterclockwise direction. The Driver 350 is 46 t hen withdrawn fron the outer sheatLh, then the Outer Sleeve 00140 is removed. This leaves the Ipln fullY installed and inset to the determined depth as shoirn in Figuze 18.

Attention is then redirected to the other, or first, side of the spine. A d'aral nerve root retractor is.

used to retract the neural str-uctures .medially, bringing into full view the head 128 of the Short Distractor 120, lying flush on the canal floor. utilizing apparatuS 152, extended screw~ uortion 116 is inserted into t-he female theaded oortior. 114 of the Short Distractor 1 20 a s th e extended rectangular portion 134 of apparatus 152 is engaged to the female rectangular portion 118 of the Short Distractor 120. Then turning rearward facing portions 108 and 110, utilizing thbe knob 136 of Fig-ure 2, the Long Dist-actor configuration is restored.

W1 i th -th e dural sac and nerve r~oots stil retracted and protected, the outer Sleeve 140 -is slipped over -the reconstituted Long DiStr-actor and seated using the Driver Cap 162. The entire seo-Lience of events as described for the imolantation of the spinal implant I as already placed, is then repeated such that both spinal immilants come to lie side by side within the interspace. Though not necessary, circlage or other internal fix:ation o10 the levels to be fused may addlition.ally b e performed, and then the wounid is closed in, thre routine manner.

BZU.ef DiscUsSion wi,,th Reerenlce o The DrawinCS o he Prfere ,-nd u-r-tnsrUITetatiO; 10 o nrOr I ntc-.,bodv\ F'us ion 47 In incorooratino Intercorooreal Predistraction And Utilizin A Guarded Sleeve 0 System Is Disclosed i Because of the absence of the spinal cord and 5 nerve roots, it is generally possible to visualize in one instance the entire width of the disc space from side to side throughout the cervical, thoracic, or lumbar spine.

In the preferred embodiment of the anterior interbody fusion, implants are placed side by side from anterior to posterior parallel to the interspace and e>ctending through into the adjacent vertebral bodies. Where the transverse width of the disc space is insufficient to allow for the use of two imolants, each of which would be large enough to protrude to the required depth into the adjacent vertebrae, then a singular and significantly larger implant may be placed centrally. With this in mind, and in light of the very detailed description of the technique and instrumentation already provided in regard to the method of posterior lumbar interbody fusion, a brief discussion of anterior spinal interbody fusion with dual implant installation will suffice, and the method for installation of a large, singular midline graft will become obvious.

The interspace to be fused is exposed anteriorly.

The soft tissues are withdrawn and protected to either side, and if necessa-y, above and below as well. It is then possible to visualize the entire width of the vertebrae anteriorly adjacent that intersace. As discussed above, the surgeon has already templated the 48 l^ appropriate patient radiographs to determine the requisite 00 distraction and optimal implant size. In the preferred 0 method, the surgeon then broadly excises the great bulk of Cl L n the nuclear disc portion. (Alternatively, the disc can be left to be removed via the drill later.) The surgeon then notes and marks a point midway from side to side anteriorly. He then inserts Long Distractor 100 centering it on a point midway between the point just noted and the lateral extent of the intervertebral space visualized anteriorly. The outer barrel portion 106 of the Distractor 100 utilized, will correspond to the outside diameter of the implants to be installed. The Distractor tips 102 inserted are sequentially larger in diameter until the optimal distraction is achieved. This optimal distraction, although suggested by the initial templating, may be visually and tactilely confirmed as performed. When the optimal distraction is achieved, the vertebral endplates will come into full congruence and parallel to the forward shaft potion 102 of the Distractor 100, causing an alteration in the alignment of the vertebrae and a significant increase in the interference fit and Dressurization at the tip, such that the instrument becomes exceedingly stable.

There is a sensation imparted to the surgeon of the tissues having moved through their elastic range to the point where the two adjacent vertebrae V begin to feel and move as if a single solid. These changes are easily appreciated visually as the vertebrae realign to become \U 49 congruent to tip 102, and can also easily be appreciated 00 via lateral Roentgenograpnh. However, should the surgeon g fail to appreciate that optimal distraction has been I achieved and attempt to further distract the interspace, he would find that extremely difficult to do because of the Cincreased resistance as the tissues are moved beyond their range of elastic deformation. Further, there would be no elasticity left to allow the vertebrae to move further apart and the sensation to the surgeon should he attempt to gently tap the oversized Distractor forward with a mallet, would be one of great brittleness.

Returning now to the procedure, when the correct intercorporeal Distractor 100 producing the ideal intersoace distraction having its barrel portion 106 corresponding to the .implant to be installed has been inserted, then its exact duplicate is inserted anteriorly equidistant to the other side of the spine. As the barrel portion 106 of Long Distractor 100 is exadtly of the same major diameter as the spinal implant I looking coaxially on end, the surgeon can then asses the anticipated side by side relationship of the dual implants when implanted.

As shown in Figures 7C and 7D, a Dual Outer Sleeve 340 consisting of a pair of hollow tubes is then introduced over the side by side Long Distractors orotruding anteriorly from the spine.. The Dual Outer Sleeve 3 0 is comorised of two hollow tubular members identical in size displaced from each other ideally the sum of the difference between the minr and major diameters of both imolants combined, but not less than that difference 0 0 for one implant, as it is possible to have the threads of one implant nest interposed to the threads of the other, in such that they both occupy a common area between them.

However, while the preferred embodiment is slightly greater than two times the difference between the major and minor diameters of the implant (the sum of both) the distance may be considerably greater. Whereas in the preferred embodiment extending-tubular portions 348 of instrument 340 are parallel, when the area between them 350, is sufficiently great, these elements may be inclined or declined relative to each other such that they either converge or diverge at their proximal ends. Paired tubular structures 348, may be bridged in part or wholly throughout their length, but are rigidly fixed by Foot Plate 344. In its preferred embodiment, a top view shows the Foot.Plate to be essentially rectangular, but without shar- corners.

Other shapes can be utilized. In side view 7D it can be appreciated, that Foot Plate 344 is contoured so as to approximate the shape of the vertebrae anteriorly.

Ex-tending forward from Foot Plate 344 are multiple sharp prongs 342 sufficiently long to affi:.: them to the vertebrae. The prongs 342 are limited in length so as to not penetrate too far posteriorly and nu.mber from 2 to but preferably 6. As the Dual Outer Sleeve 340 is driven Sfor.rd utilizing Dual Driver Cap 420, of Fig-ure 7E, engaging the rea.rward end 352, the prongs 3-42 extending ID 51 from Foot Plate 344 are embedded into the opposed vertebral 00 bodies until their forward motion is inhibited by the C1 curved Foot Plate 344 becoming congruent to and being OC stopped by, the anterior aspect of the vertebral bodies.

As already taught in Figure 5, the Dual Driver CaD 420 is of the sane design as Single Driver Cap 160, in that there is a recess 354 as per 168, allowing the Outer Sleeve to be fully seated without impeding the rearward projection of the Long Distractor unit. However, unlike in Cap 160, area 354 is more relieved as it is unnecessary for the Dual Cap 420 to contact the Long Distractor through portion 110 to inhibit its forward motion, as the Foot Plate 344 functions to that effect. Further, the Dual Cap 420 for the Dual Outer Sleeve 340 is correspondingly dual itself and engages the rearward facing dual tubular portion 352. Once the Dual Outer Sleeve has been fully seated, the vertebrae adjacent the interspace to be fused are rigidly held via Foot Plate 344 and the prongs 342. Thus, it is possible to remove either one, or if desired, both of the Long Distractor rods utilizing Long Distractor puller 200, as per the method already described. It is then the surgeon's choice to work on one or-both sides of the spine.

As per previous discussion, the surgeon may drill the interspace utilizing the Inner Sleeve 242 or leave the Long Distractors in place as per the "Treohine Method".

Tapping, if necessary, and the insertion of the imnlants then occurs through the protective Outer Sleeve 340. Once the implants have been fully inserted, the Outer DO 52 Sleeve is removed.

0 Having utilized the Drill method, or "Trephine Method", with or without an Inner Sleeve to prepare the K fusion site, it is the preferred embodiment to leave the Outer Sleeve 340 in place as it provides for the ideal placement and alignment of the Tap 280 and implant

I.

It is anticipated that the surgeon wishing to work deep within the interspace, or preferring the ability to directly visualize the tap being used, or the implant being inserted, may choose to remove the Outer Sleeve after the insertion of the first prosthesis to maintain stability, or prior to that, which while not the preferred embodiments, are nevertheless within the scope of the oresent invention.

Alternative Methods To The preerred Lbodiment For Method Of Anterior Interbodv Pusion As previously described for the posterior lumbar spine, alternatively, one can employ the "Trephine Method" as has been described in detail.

As a further alternative, it should be noted that the key element in the anterior method is. the use of the predistraction principle, where such distraction is aintained by the outer Sleeve with or without the Long maintained br tlhe Ou>-e or Distractor. Therefore, once the preparation of the interspace has been completed, while not the preferred embodiment, it is nevertheless within the scope of 29321/02 that one could rrmnov\" the Outer Sleeve as there Ct 53 are no neural structures requiring protection, and insert 00 the implants directly rather than through the Outer Sleeve.

As yet a further alternative of this method, where the height of the distracted interspace is such that the diameter of the iL-plant required to span that height N and to embed with sufficient depth into the opposed vertebral bodies is such that it is not possible to place two such implants side by side, then only a single implant which may be of significantly increased diameter, is used and placed centrally within the interspace rather than to either side. The placement of a singular central graft via the present invention method and instrumentation is in keeping with the methods already described and can be performed using either a drill or the "Trephine MethLod".

Referring to Figures 16-18, a cylindrical embodiment of the spinal implant I of the present invention is shown. In Figure 16 the implant I is sholwn attached to the insertion device 350. In Figures 17 and 18 the implant I' is shown installed in the disc space D, between the adjacent vertebrae.

The cylindrical implant I comprises a hollow tubular member which in the preferred embodiment is made of an ASTM surgically implantable material, preferably Titanium. The cylindrical implant I is closed at one end and open at the other end covered by a cap- 394. The cylindrical implant I has a series of macro-sized openings 390 through the side walls of the cylindrical implant

I.

A series of e.Zternal threads 392 are formed on the 54 n circumference of the cylindrical implant I. Any variety of threads may be used 0 on the implant. The cap 374 has a hexagonal opening 394 for tightening the

(N

cap 374.

It is recognized that forms of implants other than a threaded spinal ID 5 implant may be used. For example, dowels, made from bone or artificial materials, knurled or irregularly shaped cylinders or spheres, or any other Sshaped implants that can be introduced through the outer sleeve may be used.

0Being able to perform the procedure through the outer sleeve permits the procedure to be performed safely and quickly, and more accurately.

Claims (25)

1. A bone removal device for use in performing spinal surg ery for forming an C opening in the spine, said bone removal device including a shaft having a longitudinal 5 axis and terminating in a cutting end fdr removing bone, said cutting end having end surfaces perpendicular to the longitudinal axis and having a center which does not vi extend further than the rest of said cutting end, said shaft having a proximal end oo Sopposite said cutting end, said end surfaces of said cutting end and said shaft having cutting flutes over at least a portion of a length of said shaft.

2. The bone removal device of claim 1, wherein said cuttinig flutes are configured to guide debris generated during operation of said bone removal device toward said proximal end of said shaft.

3. The bone removal device of claim 1, wherein said cente" is indented.

4. The bone removal device of claim 1, wherein said proxirnal end of said shaft is configured for removable engagement to a driving mechanism.

The bone removal device of claim 1, further including m,.ans for limiting penetration of said cutting end into the spine.

6. The bone removal device of claim 5, wherein said limiting means is lockably adjustable.

7. The bone removal device of claim 1, further including a shoulder adapted to limit the depth of penetration of said cutting end into the spin.

8. The bone removal device of claim 1, further including a circumferential collar adapted to limit the depth of penetration of said cutting end into the spine.

9. The bone removal device of claim 1, wherein said end s jrfaces of said cutting end and said shaft have at least four cutting flutes.

The bone removal device of claim 1, wherein said cutting flutes are shallow so as to slow the advance of said bone removal device into the spine.

11. The bone removal device of claim 1, wherein said cutting end has a diameter that approximates the minor diameter of a threaded spinal implant to be inserted into the space created by said bone removal device.

12. The bone removal device of claim 1, wherein said bone removal device includes a drill W 56

13. The bone removal device of claim 1, wherein said center is indented across a 0 majority of the normal height of the disc space into which said bone removal C device is inserted.

14. The bone removal device of claim 1, wherein said center has an indented portion and at least one of said flutes intersects said indented portion. INO

15. The bone removal device of claim 1, wherein said center has an indented portion that is at least in part curved.

S16. The bone removal device of claim 1, wherein said center is concave. 00

17. The bone removal device of claim 1, wherein said center has an indented portion 10 that forms an arc of a circle.

N 10 S18. The bone removal device of claim 17, wherein the arc formed is generally semi- circular.

19. The bone removal device of claim 1, wherein said center has an indented portion that intersects the longitudinal axis of said shaft.

20. The bone removal device of claim 19, wherein said indented portion is centered about the longitudinal axis of said shaft.

21. The bone removal device of claim 1, in combination with a guard member having an opening for providing protected access to the disc sp ace and the adjacent vertebral bodies and for guiding said device into contact with the adjacent vertebral bodies.

22. The bone removal device of claim 1, in combination with a spinal insert.

23. The bone removal device of claim 22, wherein said spinal insert is a spinal fusion implant.

24. The bone removal device of claim 22, wherein said spinal insert is in combination with a fusion promoting material.

25. The bone removal device of claim 24, wherein said fusicn promoting material includes bone. DATED: 16 May 2005 PHILLIPS ORMONDE FITZPATRICK Attorneys for: KARLIN TECHNOLOGY INC.