US20210322184A1 - Adjustable interbody fusion devices and methods of use - Google Patents

Abstract

Interbody fusion devices, insertion tools, methods for assembling an interbody fusion device, and methods for inserting a medical device between two vertebral bodies are disclosed. The interbody fusion device includes a base member, a top member, and at least one movement mechanism. The base member includes at least one of a pivotal cylinder and a hinge channel. The top member includes at least one of a pivot cylinder and a hinge channel. The at least one pivot cylinder of the base member engages the at least one hinge channel of the top member and the at least one pivot cylinder of the top member engages the at least one hinge channel of the base member. The at least one movement mechanism engages the top member and the base member. Also disclosed are a vertebral spacer device and an interbody spacer system including an insertion tool and an interbody fusion device.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This application is a continuation of U.S. Non-Provisional patent application Ser. No. 16/401,852 filed May 2, 2019, which will issue as U.S. Pat. No. 11,045,327 on Jun. 29, 2021, which is a continuation of U.S. Non-Provisional patent application Ser. No. 15/991,460 filed on May 29, 2018, now U.S. Pat. No. 10,278,832, which is a continuation of U.S. Non-Provisional patent application Ser. No. 14/890,837 filed on Nov. 12, 2015, now U.S. Pat. No. 9,980,825, which was a 371 National Phase Application of PCT/US2014/037884 filed on May 13, 2014, which claimed priority benefit under 35 U.S.C. § 119(e) to U.S. provisional application No. 61/822,620 filed May 13, 2013, each of which is hereby incorporated herein by reference in their entireties.
TECHNICAL FIELD
• The present invention relates generally to general surgery, orthopedic and neurosurgical implants used for insertion within a space between hard tissue structures, and more specifically, but not exclusively, concerns devices implanted between bones to replace resected, fractured or diseased structures and to maintain or reestablish proper spacing between two bones.
BACKGROUND OF THE INVENTION
• Damage or disease that affects the integral structure of a bone or other structures, may lead to neurologic impairment or loss of structural support integrity with possible permanent damage to the surrounding soft tissue and adjacent neurologic, vascular and systemic structures. Maintaining or reestablishing anatomic spacing within a bone structure or other structural tissue is critical to ensuring continued functionality and mobility of the patient and avoidance of long-term serious neurological, vascular or other systemic impairments. Please note that the terms “implant” and “device” may be used interchangeably and have the same meaning herein.
SUMMARY OF THE INVENTION
• Advancement of the state of interbody fusion devices and implants and the surgical management relating to the clinical presentation of damaged tissue structures within the body is believed desirable. Example embodiments of the invention that satisfies the need for improvements to an expandable interbody fusion device used to treat patients suffering from either diseased or damaged disc or other tissue structures includes a superior member coupled to a body member.
• The present invention provides in one aspect, an interbody fusion device including a base member, a top member, and at least one movement mechanism. The base member includes at least one pivot cylinder and at least one hinge channel. The top member includes at least one pivot cylinder and at least one hinge channel. The at least one pivot cylinder of the base member engages the at least one hinge channel of the top member and the at least one pivot cylinder of the top member engages the at least one hinge channel of the base member. The at least one movement mechanism engages the top member and the body member.
• The present invention provides in another aspect, an interbody spacer system including an insertion tool and an interbody fusion device. The insertion tool may include a handle, an insertion end, at least one tube extending distally away from the handle and connecting the handle and the insertion end. The tool may also include a securement mechanism and at least one adjustment mechanism coupled to the handle and extending through the at least one tube and protruding from the insertion end. The tool may further include a first knob for actuating the securement mechanism and at least one second knob for actuating the adjustment mechanism. The interbody fusion device may include an inferior member, a superior member, and at least one movement mechanism engaging the superior member and the inferior member. The inferior member includes at least one of a pivot cylinder and a hinge channel, a tool alignment opening for receiving the securement mechanism of the insertion tool, and an adjustment opening adjacent the tool alignment opening for receiving the at least one adjustment mechanism. The superior member includes at least one pivot cylinder and a hinge channel. The at least one pivot cylinder of the inferior member engages the at least one hinge channel of the superior member and the at least one pivot cylinder of the superior member engages the at least one hinge channel of the inferior member.
• The present invention provides in yet another aspect, a base member, a top member, and at least one movement mechanism. The base member includes at least one pivot cylinder. The top member includes at least one hinge channel, at least one contact area on a bottom surface of the top member, and at least one stop pin extending out from the at least one contact area. The at least one pivot cylinder engages the at least one hinge channel to allow pivoting motion. The at least one movement mechanism engages the at least one contact area of the top member and the base member to facilitate movement therebetween.
• Further, additional features and advantages are realized through the techniques of the present invention. Other embodiments and aspects of the invention are described in detail herein and are considered a part of the claimed invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• The subject matter which is regarded as the invention is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. It is emphasized that, in accordance with the standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion. The foregoing and other objects, features and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which:
• FIG. 1 is a posterior perspective view of one embodiment of an expandable interbody fusion device, in accordance with an aspect of the present invention;
• FIG. 2 is a posterior perspective view of the expandable interbody fusion device ofFIG. 1 with the moveable members extended, in accordance with an aspect of the present invention;
• FIG. 3 is a posterior view of the expandable interbody fusion device ofFIG. 1 with the moveable members extended, in accordance with an aspect of the present invention;
• FIG. 4 is an exploded view of the expandable interbody fusion device ofFIG. 1, in accordance with an aspect of the present invention;
• FIG. 5 is a superior perspective view of the expandable interbody fusion device ofFIG. 1, showing only the base or bottom member, in accordance with an aspect of the present invention;
• FIG. 6 is an inferior perspective view of the expandable interbody fusion device ofFIG. 1, showing only the top or superior member, in accordance with an aspect of the present invention;
• FIG. 7 is an exploded view of the expansion mechanism of the expandable interbody fusion device ofFIG. 1, in accordance with an aspect of the present invention;
• FIG. 8 is a posterior elevational view of the expandable interbody fusion device ofFIG. 1 without the top member, showing the expansion assemblies seated in the transparent base member, extended and tilted to accommodate the slanted top member, in accordance with an aspect of the present invention;
• FIG. 9 is a partially exploded posterior perspective view of the expandable interbody fusion device ofFIG. 1 showing the locking mechanism being inserted into the interbody fusion device, in accordance with an aspect of the present invention;
• FIG. 10 is an isometric view of the locking mechanism ofFIG. 9, in accordance with an aspect of the present invention;
• FIG. 11 is a posterior perspective view of the expandable interbody fusion device ofFIG. 1 with a transparent base member showing a drive rod and locking mechanism, in accordance with an aspect of the present invention;
• FIG. 12 is a top perspective view of an expansion tool, in accordance with an aspect of the present invention;
• FIG. 13 is a top perspective view of the expansion tool ofFIG. 12 with a transparent handle portion and housing portion, in accordance with an aspect of the present invention;
• FIG. 14 is an exploded view of the expansion tool ofFIG. 12, in accordance with an aspect of the present invention;
• FIG. 15 is a perspective view of one embodiment of an expandable interbody fusion device, in accordance with an aspect of the present invention
• FIG. 16 is a perspective view of the expandable interbody fusion device ofFIG. 15 with the moveable members extended, in accordance with an aspect of the present invention;
• FIG. 17 is a posterior view of the expandable interbody fusion device ofFIG. 15 with the moveable members extended, in accordance with an aspect of the present invention;
• FIG. 18 is an exploded view of the expandable interbody fusion device ofFIG. 15, in accordance with an aspect of the present invention;
• FIG. 19 is a superior perspective view of the expandable interbody fusion device ofFIG. 15, showing only the base or bottom member, in accordance with an aspect of the present invention;
• FIG. 20 is an inferior perspective view of the expandable interbody fusion device ofFIG. 15, showing only the top or superior member, in accordance with an aspect of the present invention;
• FIG. 21 is an exploded view of the expansion mechanisms of the expandable interbody fusion device ofFIG. 15, in accordance with an aspect of the present invention;
• FIG. 22 is a posterior perspective view of the expandable interbody fusion device ofFIG. 15 without the top member, showing the expansion assemblies seated in the transparent base member, extended and tilted to accommodate the slanted top member, in accordance with an aspect of the present invention;
• FIG. 23 is a perspective view of the expandable interbody fusion device ofFIG. 15 with a transparent base member showing a drive rod and locking mechanism, in accordance with an aspect of the present invention;
• FIG. 24 is a perspective view of the expandable interbody fusion device ofFIG. 15 and an expansion tool, in accordance with an aspect of the present invention;
• FIG. 25 is a perspective view of the expansion tool ofFIG. 24, in accordance with an aspect of the present invention;
• FIG. 26 is a truncated anterior view of the attachment end of the expansion tool ofFIG. 24, in accordance with an aspect of the present invention;
• FIG. 27 is a perspective view of the expansion tool ofFIG. 24 with a transparent outer housing, in accordance with an aspect of the present invention;
• FIG. 28 is a truncated distal view of the handle end of the expansion tool ofFIG. 24 with a transparent outer housing, in accordance with an aspect of the present invention;
• FIG. 29 is an exploded view of the tool ofFIG. 24, in accordance with an aspect of the present invention;
• FIG. 30 is an exploded view of the handle portion of the tool ofFIG. 24, in accordance with an aspect of the present invention;
• FIG. 31 is an exploded view of the insertion portion of the tool ofFIG. 24, in accordance with an aspect of the present invention;
• FIG. 32 is a perspective view of the expandable interbody fusion device ofFIG. 15 and the tool ofFIG. 24, in accordance with an aspect of the present invention;
• FIG. 33 is a perspective view of the tool ofFIG. 24 engaging the expandable interbody fusion device ofFIG. 15, in accordance with an aspect of the present invention;
• FIG. 34 is a truncated view of the tool ofFIG. 24 inserted into the implant ofFIG. 15, in accordance with an aspect of the present invention;
• FIG. 35 is a perspective view of the tool ofFIG. 24 engaging the expandable interbody fusion device ofFIG. 15 in an expanded position, in accordance with an aspect of the present invention;
• FIG. 36 is an isometric view of an expandable interbody fusion device with a transparent top member and the moveable member extended, in accordance with an aspect of the present invention;
• FIG. 37 is an exploded superior view of the expandable interbody fusion device ofFIG. 36, in accordance with an aspect of the present invention;
• FIG. 38 is an exploded inferior view of the expandable interbody fusion device ofFIG. 36, in accordance with an aspect of the present invention;
• FIG. 39 is a perspective view of a partially open expandable interbody fusion device, in accordance with an aspect of the present invention;
• FIG. 40 is an exploded view of the expandable interbody fusion device ofFIG. 39, in accordance with an aspect of the present invention; and
• FIG. 41 is an inferior perspective view of the expandable interbody fusion device ofFIG. 39, showing only the top or superior member, in accordance with an aspect of the present invention.
DERTAILED DESCRIPTION FOR CARRYING OUT THE INVENTION
• Generally stated, disclosed herein is an interbody fusion device or interbody device that typically includes a top member, a base member, and at least one expansion mechanism. Further, the interbody fusion device may include an extendable/retractable member or expansion assembly and an expansion tool for expansion and contraction of the interbody device. The retractable member extending in a vertical direction. As used herein, the terms “interbody fusion device,” “medical device,” “device,” “interbody device” and “implant” may be used interchangeably as they essentially describe the same type of device. Further, the corresponding expansion tool may also be referred to as “tool” or “instrument” and these terms may be used interchangeably. Finally, described herein is a surgical method for using the interbody fusion device to maintain a space between two vertebral bodies within a patient suffering from a diseased or damaged disc or spinal column.
• In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, “proximal” means the portion of an implant nearest the torso, while “distal” indicates the portion of the implant farthest from the torso. As for directional terms, “anterior” is a direction towards the front side of the body, “posterior” means a direction towards the back side of the body, “medial” means towards the midline of the body, “lateral” is a direction towards the sides or away from the midline of the body, “superior” means a direction above and “inferior” means a direction below another object or structure.
• As depicted inFIGS. 1-3, the general arrangement of an adjustableinterbody fusion device100, in one embodiment, includes abase member110, at least one moveabletop member130, and anexpansion mechanism140. Thetop member130 may be detachably coupled to thebody member110. As used herein, the terms “base member,” “body member,” “bottom member” and “inferior member” may be used interchangeably herein as they essentially describe the same element of the device. Also as used herein, the terms “top member,” “superior member,” and “moveable member” may be used interchangeably as they essentially describe the same clement of the device. Thedevice100 as seen inFIG. 1 may have, for example, a generally rectangular geometry with various configured long sides to facilitate insertion and bone coverage. Although it would be understood by one skilled in the art that other outside configurations can be used.
• As seen inFIGS. 1 and 2,base member110 may have at least one through hole orcentral opening102 for insertion of bone graft material disposed on the inferior and superior bone contacting surfaces104. Theopening102 typically extends through bothbone contacting surfaces104 of the base andtop members110,130 and into the inner cavity of the assembleddevice100. The size and configuration of theopening102 allow the surgeon to place bone graft material inside theimplant100 to achieve a continuous fusion between the inferior and superior vertebral bodies.
• As shown inFIG. 1, the superior and inferiorbone contacting surfaces104 may be generally parallel to each other. However, the expansion mechanism or movement mechanism140 (these names may be used interchangeably) will allow the user to angle or raise one side of thebone contacting surface104 of thetop member130 relative to thebone contacting surface104 of thebase member110 as seen inFIGS. 2 and 3, wherein the near side is fully expanded and the far side remains stationary.FIGS. 1-4 show thebone contacting surfaces104 to have teeth-like or tine structures projecting away from the superior and inferior surfaces. One skilled in the art would recognize that other surface treatments may be applied to thebone contacting surfaces104 to enhance fixation with the opposing bone surface. Although not shown, it is understood by one skilled in the art that modular bone contacting surfaces, caps or plates may be used to provide for varying types of bone contacting surfaces and structures, including, but not limited to sharp tines, porous coatings, biomaterial or ingrowth surfaces, and ridge structures. It is also understood that thebone contacting surfaces104 may be coated with nano-surfacing, bioactive or bone/tissue ingrowth coatings.
• As seen inFIGS. 4 and 5, thebase member110 may also include atool alignment opening112 on the posterior end of thebase member110, a tool attachment opening114 in thetool alignment opening112, and anadjustment opening116 on the posterior end of thebase member110 and which may be adjacent to thetool alignment opening112, as seen inFIGS. 1-5. Thebase member110 may also include at least one hole orlumen118 near the proximal and/or distal ends of thebase member110 to house anexpansion mechanism140, which will be discussed in greater detail below. In one embodiment, as illustrated inFIGS. 1-11, thebase member110 may include, for example, twoholes118, although only onehole118 as well as more than twoholes118 arc also contemplated. Theholes118 may have a smooth vertical wall to facilitate insertion and unrestricted rotation of acylindrical gear150 of theexpansion mechanism140. Theholes118 of thebase member110 may also include an internalcircumferential shoulder120 and achannel122 extending from theadjustment opening116 interiorly along a lateral side of thebase member110 to engage theholes118. Thebase member110 may also include at least onepivot cylinder124, at least onehinge channel126, and anopening128. The at least onepivot cylinder124 and the at least onehinge channel126 may alternate as depicted inFIGS. 4 and 5.
• As seen inFIGS. 4 and 6, the top orsuperior member130 also includes anundersurface132 with at least onerelief area134 that is adjacent to thecentral opening102. Thecentral opening102 may be configured to permit the insertion of bone graft material into the inner cavity of theimplant100 prior to or after implantation. In one embodiment, as illustrated inFIGS. 1-11, thetop member130 may include, for example, tworelief areas134, although asingle relief area134 as well as more than tworelief areas134 are also contemplated. The at least onerelief area134 may extend from a position on theundersurface132 of thetop member130 to at least one lateral side of thetop member130. Therelief areas134 may be substantially planar and may be aligned with theholes118 in thebase member110. Therelief areas134 are relatively rectangular with the long axis of the rectangle extending along the lateral axis of thetop member130 or perpendicular to the longitudinal axis of thedevice100.
• As seen inFIGS. 4-6, therelief areas134 may be configured to mate with at least one correspondingly shapedload head170 of theexpansion mechanism140. Thetop member130 may also include at least onehinge channel136 and at least onepivot cylinder138 and thehinge channels136 may alternate with thepivot cylinders138, as depicted inFIG. 6. The at least onehinge channel136 of thetop member130 may mate with the at least onepivot cylinder124 of thebase member110 and the at least onepivot cylinder138 of thetop member130 may mate with the at least onehinge channel126 of thebase member110 to enable theimplant100 to extend on a firstlateral side106 while remaining closed on a secondlateral side108. Apin139 may be inserted intoopenings125,137 in thepivot cylinders124,138, respectively, to pivotally secure thetop member130 to thebase member110. Thepivot cylinders124 and hingechannels126 of thebase member110 and thehinge channels136 andpivot cylinders138 of thetop member130 allow thehinge channels126,136 to pivot or rotate around the outer diameter of thepivot cylinders124,138 when the at least oneexpansion assembly142 is extended or retracted causing thetop member130 to tilt or slant relative to thebase member130. In another embodiment, thebase member110 may include apivot cylinder124 and thetop member130 may include ahinge channel136, alternatively, thebase member110 may include ahinge channel126 and thetop member130 may include apivot cylinder138.
• Referring now toFIG. 4 with continued reference toFIGS. 5 and 6, an exploded view of all of the components that comprise theimplant100 is shown. As shown inFIG. 7, theexpansion mechanism140 of theimplant100 includes at least oneexpansion assembly142 and adrive rod180. In one embodiment, as shown inFIG. 7, theexpansion mechanism140 includes twoexpansion assemblies142. Theexpansion assemblies142 may include acylindrical gear150, a support means158, a threadedrod160, and aload head170. The vertical cylinder or cylindrical gears150 (these names may be used interchangeably) may nest or be suspended within theholes118 of thebase member110. The cylindrical gears150 may include external substantially vertical depressions or circumferentialserial depressions152 positioned on the outer surface of thegears150 which extend around the entire circumference. For example purposes, thegears150 may have a smooth surface, above and below the substantiallyvertical depressions152. Positioning the circumferentialserial depressions152 around the central portion of thegears150 may maximize strength and improve trackability when the cylindrical gears150 engage thedrive rod180. The circumferentialserial depressions152 may also include uniquely oriented thread patterns. In addition, thegears150 may includeinternal threads154 on the interior surface of thegears150.
• As shown inFIG. 8, the support means158 may sit on theshoulders120 of thebase member110 and function to maintain theexpansion assemblies142 in a vertical orientation relative to thebase member110 and aligned with theholes118. The support means158 may also be used adjacent to thegears150 and threadedrods160 and may hold thegears150 in theholes118. The support means may, for example, be in the form of a ring, snap ring, washer or other similar type of structure that will secure theexpansion assemblies142 to thebase member110. Theshoulders120 may also operate as bearing surfaces against which the support means158 contacts to facilitate the rotation of theexpansion assemblies142 when actuated.
• As shown inFIGS. 4, 7 and 8, the threadedrods160 may include apivot cylinder162 located on the top or superior end of the threadedrods160. The terms “pivot cylinder,” “arcuate surface” and “curved surface” may be used interchangeably herein as they all refer to the same structure of the threaded rods. The threadedrods160 may also includeexternal threads164 extending along its length. Theexternal threads164 may be configured to match theinternal threads154 of thegears150. Thepivot cylinder162 of the threadedrods160 may be inserted into adistal channel172 of the load heads170. These constructs allow the load heads170 to pivot, slide, or rotate around the outer diameter of thepivot cylinders162 when the threadedrods160 are extended causing thetop member130 to tilt or slant. Tilted or slanted load heads170 are shown inFIGS. 3 and 8. The load heads170 may also include superior head surfaces174. The superior head surfaces174 may be shaped to match with the correspondingrelief areas134 on theundersurface132 of thetop member130. The superior head surfaces174 are configured to slide within thereliefs134 of theundersurface132, if necessary, to allow for theexpansion assemblies142 to lengthen to create the angled relationship of thetop member130 relative to thebase member110. Thereliefs134 in theundersurface132 and the correspondingly shaped load heads170 facilitate the angulation process and the load transfer between thetop member130 and thebase member110 while avoiding potential binding of theexpansion assemblies142 during the expansion and retraction process.
• Thedrive rod180 of theexpansion mechanism140 may be inserted into theadjustment opening116 and sit in thechannel122 of thebase member110, as shown inFIGS. 4, 7, and 8. Thedrive rod180 may include of afirst worm gear182, asecond worm gear184 and acylindrical shaft186. Thefirst worm gear182 and thesecond worm gear184 may also havetool openings188 at a second end opposite the first end with thecylindrical shaft186 for coupling with atool200. Thetool opening188 of thesecond worm gear184 may mate with a corresponding protrusion on the first end of the first worm gears182 to facilitate simultaneous rotation of both worm gears182,184. In another embodiment, thedrive rod180 may include a single worm gear and acylindrical shaft186, the single worm gear would have a length to enable engagement with bothgears150 simultaneously. In addition, thecylindrical shaft186 may include an opening176 for mating with apin190 to secure thedrive rod180 in thebase member110 to enable adjustment of thetop member130 without thedrive rod180 moving out of theimplant100. Thepin190 may also prevent thedrive rod180 from advancing out of theimplant100 after implantation into the patient's spine. By off-centering theadjustment opening116 and thechannel122 from the longitudinal axis of thedevice100, the worm gears182,184 of thedrive rod180, which are inserted into thechannel122, intersect with theholes118 of thebase member110. The worm gears182,184 may be configured to engage with thegears150 of theexpansion assemblies142 which sit in theholes118 of thebase member110.FIG. 8 shows the assembledimplant100 without thetop member130 with thedrive rod180 positioned and extending through the length of thebase member110.
• When theimplant100 is inserted into apatient using tool200, as shown inFIGS. 12-14, thetool200 engages thealignment opening112, theattachment opening114 and theadjustment opening116, as described in greater detail below. Once thetool200 is inserted into the patient between two vertebrae, thedrive rod180 with thegears150 function to mirror the rotational movement exerted by thetool200, described in greater detail below, and translate the movement to thegears150. Theexpansion mechanism140 functions to convert rotation movement of thegears150 into linear or translational movement of the load heads170 positioned at the superior end of the threadedrods160. Rotation of thegears150 will result in a travel distance of the threadedrods160 when theexpansion mechanism140 is actuated by thetool200. As thegears150 are coupled to thedrive rod180, the coupled gears150 will turn as thedrive rod180 is rotated, thus avoiding the need for thetool200 to pass through the entire length of thechannel122 to engage thegear150 on the far end of theimplant100. Specifically, thesecond worm gear184 is coupled to thedrive rod180 on the far end of theimplant100 and thefirst worm gear182 is coupled to thedrive rod180 on the near end of theimplant100.
• With continued reference toFIGS. 1-11, as thedrive rod180 is rotated by thetool200 theteeth178 of the worm gears182,184 of thedrive rod180 are configured to mate with the substantiallyvertical depressions152 of thegears150. As described above, theexpansion assemblies142 act to covert rotational movement of thegears150 into translational movement of the threadedrods160. This is achieved by allowing free rotational movement of thegears150 while restricting the rotation of the threadedrods160. By restricting the rotation of the threadedrods160, the rods translate in either an upward or downward direction relative to thegears150 depending upon whether the threads (external and internal)154,164 are oriented in a right-handed or left-handed direction. As discussed above, when the threadedrods160 move, the load heads170 contact therelief areas134 of theundersurface130 of thetop member130 to either move it away from or towards thebase member110. In other words, the height of theimplant100 either increases or decreases or thebone contacting surface104 will be angled relative to thebase member110 depending on the rotational direction of thetool200.
• Referring now toFIGS. 9-11, alocking mechanism192 for an embodiment of the adjustableinterbody fusion device100 is shown. As shown inFIG. 10, thelocking mechanism192 may include ashaft194 extending out from ahead196. Thehead196 may include a plurality ofprotrusions198 for engaging thelip129 in theadjustment opening116 of thebase member110 to secure thelocking mechanism192 in thebase member110. Thehead196 may also include anopening199 for engaging theinsertion tool200 or a similar tool. Theshaft194 of thelocking mechanism192 may have a shape which corresponds to the shape of thetool openings188 in the worm gears182,184 of thedrive rod180, for example, the shape may be a hexagon, square, or other multi-lobed configuration allowing theshaft194 of thelocking mechanism192 to fit securely within theopenings186 of thedrive rod180. Theshaft194 of thelocking mechanism192 may be inserted, for example, through theopening186 of thefirst worm gear182 and into theopening186 in thesecond worm gear184. Alternatively, theshaft194 of thelocking mechanism192 may be inserted, for example, into theopening186 of thefirst worm gear182 to lock both the first and second worm gears182,184 in the selected position where thefirst worm gear182 includes a protrusion on the first end that engages theopening186 in thesecond worm gear184. Similarly, thehead196 may have a shape which corresponds to the shape of theadjustment opening116, for example, the shape may be a circle, hexagon, square, or other multi-lobed configuration allowing thelocking mechanism192 to securely fit within theadjustment opening116 of thebase member110 to secure thelocking mechanism192 in theimplant100 to maintain a desired expansion or retraction. Other shapes for theshaft194 and thehead196 of thelocking mechanism192 are also contemplated. Thelocking mechanism192 may be, for example, made of a rigid material or a deformable material. If thelocking mechanism192 is made of a deformable material it may be made slightly larger than theopening186 in thedrive rod180 and/or theadjustment opening116 in thebase member110, such that once it is inserted the larger size locks thedrive rod180 in the desired position.
• Referring now toFIGS. 12-14, oneembodiment expansion tool200 designed to engage and insert theimplant100 into a patient is shown. Thetool200 is designed to engage theexpansion mechanism140. Theinsertion end202 of thetool200 may be configured with ahousing204 including aprotrusion206 shaped to correspond to thealignment opening112 in thebase member110. Theinsertion end202 may also include anadjustment mechanism208 and asecurement mechanism210 which protrude out of the distal end of thehousing204. Theadjustment mechanism208 may be configured, for example, to have a hex male head, square, or other multi-lobed configuration that will allow for the user to rotate theknob224 of thetool200 and cause theexpansion mechanism140 to rotate. Opposite theinsertion end202, thetool200 has ahandle212 which may be connected to thehousing204 by anattachment member214. Theattachment member214 may be coupled to thehousing204 on the proximal end and secured to thehandle212 byfasteners248, for example, screws, pins, rivets, and the like. Thetube214 may house theadjustment mechanism208 and thesecurement mechanism210 which may extend from thehandle212 to theinsertion end202 inside thehousing204.
• As seen inFIG. 13, thehandle212 of thetool200 may also include afirst opening216 along the longitudinal axis of thehandle212. In addition, thehandle212 oftool200 may include asecond opening218 extending perpendicular to and engaging thefirst opening216. Thehandle212 may also include afirst knob220 which may be inserted into thefirst opening216 at a proximal end of thehandle212 to engage theadjustment mechanism208. Anactuation bar226 may be inserted into thesecond opening218. Agear228 may be inserted into thefirst opening216 prior to inserting thefirst knob220 enabling thegear228 to engage thefirst knob220 as it is inserted into thehandle212 to engage theadjustment mechanism208. Theknob220 may include ahead236 with ashaft238 extending out away from the inferior surface of thehead236. Theshaft238 of theknob220 may also include an opening for mating with theadjustment mechanism208 to secure theknob220 to theadjustment mechanism208.
• Asecond knob222 may couple to the proximal end of thehandle212 over theopening216 and thegear228. Thegear228 may include teeth on the exterior surface which engage corresponding grooves on the interior surface of thesecond knob222. Thesecond knob222 may be rotatably secured to thehandle212 by anend plate252 which may be attached to thehandle212 usingfasteners248, for example, screws. Athird knob224 may couple to the proximal end of thehousing204 at the distal end of thehandle212. Thethird knob224 may also engage agear250 which aligns with a channel in the attachment means214 of thehousing204. Thegear250 may include grooves circumferentially around the exterior surface that mate with corresponding grooves circumferentially around the interior surface of thethird knob224.
• As seen inFIGS. 12 and 13, theadjustment mechanism208 may pass into thefirst opening216 from the proximal end of thehandle212. Theadjustment mechanism208 may be secured to the distal end of theshaft238 of theknob220 prior to insertion into thefirst opening216 from the proximal end of thehandle212. Atool engagement end242 of theadjustment mechanism208 couples with the distal end of theshaft238 to enable rotation of theadjustment mechanism208. Thetool engagement end242 of theadjustment mechanism208 when inserted into thefirst opening216 passes through ahole230 in theactuation bar226 before engaging theshaft238 of theknob220. Theadjustment mechanism208 may include afirst channel232, asecond channel234, and athird channel240 for engaging thehole230 in theactuation bar226 to secure theadjustment mechanism208 at a desired length at theinsertion end202. Thesecurement mechanism210 may pass into thesecond opening218 from the distal end of thehandle212 enabling engagement with the distal end of theshaft238 of theknob220 when inserted into thesecond opening218 from the proximal end of thehandle212. In addition, thesecurement mechanism210 may include aspring mechanism246 inserted over the proximal end of thesecurement mechanism210 to spring load thesecurement mechanism210. Thespring mechanism246 may also engage anend member250 in thehandle212 which may provide a bearing surface for thespring mechanism246 to engage. Atool engagement end244 of thesecurement mechanism210 couples with agear250 which engages the interior surface of thethird knob224 to enable rotation of thesecurement mechanism210. The tool engagement ends242,244 may have, for example, a hex male head, square, or other multi-lobed configuration to enable rotation of theadjustment mechanism208 orsecurement mechanism210, respectively.
• During use, thetool200 may be inserted into theimplant100 by aligning theprotrusion206 of theinsertion end202 of thetool200 with thealignment opening112 of theimplant100. Thethird knob224 may then be rotated thereby rotating thegear250 and the engagedsecurement mechanism210. As theknob224 is rotated the threaded end of thesecurement mechanism210 engages the threads in the tool attachment opening114 of theimplant100 to secure theimplant100 to thetool200 for insertion into a patient. In addition, as thesecurement mechanism210 engages the attachment opening114 of theimplant100, theadjustment mechanism208 of the tool will engage theopening186 in thedrive rod180 of theimplant100.
• Once thetool200 andimplant100 are aligned and theshaft238 of theknob220 is coupled to thetool engagement end242 of theadjustment mechanism208, theadjustment mechanism208 may be inserted into thefirst opening216. As theadjustment mechanism208 is inserted into thehandle212, theactuation bar226 is depressed allowing for theadjustment mechanism208 to pass through thehole230 in theactuation bar226. Theadjustment mechanism208 passes through thehandle212 and thehousing204 and extends out of theinsertion end202 to pass through theadjustment opening116 of theimplant100 and engage theexpansion mechanism140. Once theadjustment mechanism208 engages theexpansion mechanism140 theactuation bar226 may be released to engage one of thechannels232,234,240 of theadjustment mechanism208 and maintain the position of theadjustment mechanism208 at a desired length.
• After theactuation bar226 of thehandle212 has engaged achannel232,234,240, theimplant100 may then be inserted into the desired position in the patient. Thehead236 of theknob220 may then be rotated which in turn will rotate the distal end of theadjustment mechanism208. As thehead236 of theknob220 is rotated, theadjustment mechanism208, which is coupled to theopening186 in thedrive rod180, engages theexpansion mechanism140 and expands a side of theimplant100 to angle thetop member130 relative to thebase member110. The cogs orteeth178 of the worm gears182,184 of thedrive rod180 are sized to mate with the correspondingserial depressions152 of thegears150 to facilitate rotation of thegears150 when theknob220 of thetool200 is turned. Alternatively, thesecond knob222 may be used to rotate theadjustment mechanism208 to facilitate rotation of thegears150 to expand a side of theimplant100. Thefirst knob220 enables slower rotation of theadjustment mechanism208, while thesecond knob222 enables faster rotation of theadjustment mechanism208 enabling faster opening or closing of theimplant100. Once the desired expansion of theimplant100 is achieved, thetool200 may then be removed from the patient.
• In the embodiment shown inFIGS. 12-14, prior to removing thetool200, thelocking mechanism192 may be inserted into theimplant100 to secure thetop member130 of theimplant100 in the desired expansion and/or retraction relative to thebase member110. Thelocking mechanism192 may be inserted into theopening186 in thedrive rod180 by removing theadjustment mechanism208 andfirst knob220 from thetool200 by depressing theactuation bar226 and pulling theknob220 out of theopening216. Once theadjustment mechanism208 has been removed a locking tool, not shown, with alocking mechanism192 coupled to an insertion end of the locking tool may be inserted into theopening216 through thehandle212 and thehousing204 existing theinsertion end202 to engage theimplant100.
• As thelocking mechanism192 is inserted into thebase member110 and thedrive rod180, theshaft194 of thelocking mechanism192 fits securely within theopening186 of thedrive rod180. In one embodiment, theshaft194 may extend through theopening186 in thefirst worm gear182 and into theopening186 in thesecond worm gear184. Alternatively, in another embodiment, ashorter shaft194 may extend into theopening186 in thefirst worm gear182 and the first and second worm gears182,184 may be coupled such that thelocking mechanism192 inserted into thefirst worm gear182 secures both the worm gears182,184 in the desired position. In addition, the plurality ofprotrusions198 on thehead196 may engage thelip129 in theadjustment opening116 of thebase member110, as shown inFIGS. 9-11. Thedrive rod180 may be recessed within thebase member110 to provide a cavity for insertion of thelocking mechanism192 into thebase member110, such that when thelocking mechanism192 is inserted into thebase member110 of theimplant100 it is flush with the exterior surface of thebase member110.
• Thetool200 may be removed from the patient by removing theadjustment mechanism208 or the locking insert mechanism. Theadjustment mechanism208 or the locking insert mechanism may be removed from thefirst opening216 by depressing theactuation bar226 to disengage theactuation bar226 from thechannel232,234,240 or a channel in the locking insert mechanism, not shown. Once theactuation bar226 is disengaged theadjustment mechanism208 or the locking insert mechanism may be removed from thefirst opening216. Next, thesecurement mechanism210 may be disengaged from theimplant100 by rotating thethird knob224 which in turn rotates thesecurement mechanism210. As thesecurement mechanism210 rotates it disengages thethreads108 of theattachment opening114 and theprotrusion206 of theinsertion end202 of thetool200 slide out of thealignment opening112. It is also contemplated that the above method for inserting theimplant100 usingtool200 may be performed in alternative orders.
• As depicted inFIGS. 15-17, the general arrangement of an adjustableinterbody fusion device300, in one embodiment, includes abase member310, at least one moveabletop member330, and at least oneexpansion mechanism340. Thedevice300 as seen inFIG. 15 may have, for example, a generally rectangular geometry with various configured long sides to facilitate insertion and bone coverage. Although it would be understood by one skilled in the art that other outside configurations, including square-like shapes, can be used. Thetop member330 may be detachably coupled to thebody member310.
• As seen inFIGS. 15 and 16,base member310 may have at least one through hole orcentral opening302 for insertion of bone graft material disposed on the inferior and superior bone contacting surfaces304. Theopening302 typically extends through bothbone contacting surfaces304 of the base andtop members310,330 and into the inner cavity of the assembleddevice300. The size and configuration of theopening302 allow bone graft material to be inserted inside theimplant300 to achieve a continuous fusion between the inferior and superior vertebral bodies.
• As shown inFIG. 15, the superior and inferiorbone contacting surfaces304 may be generally parallel to each other. However, the expansion mechanisms or movement mechanisms340 (these names may be used interchangeably) allow the user to angle one side of thebone contacting surface304 of thetop member330 relative to thebone contacting surface304 of thebase member310 as seen inFIGS. 16 and 17, wherein the near side is fully expanded and the far side remains retracted. As shown inFIGS. 15-18 thebone contacting surfaces304 are of the type described above with reference to thebone contacting surfaces104 ofimplant100 and for brevity sake will not be described again here.
• As seen inFIGS. 18 and 19, thebase member310 may also include atool alignment opening312 on a first lateral side of thebase member310, a tool attachment opening314 in thetool alignment opening312, and afirst adjustment opening316 and second adjustment opening317 on the lateral side of thebase member310 and which may be on opposite sides of thetool alignment opening312, as seen inFIGS. 15-19. Thebase member310 may also include at least one hole orlumen318 near the proximal and/or distal ends of thebase member310 to house at least oneexpansion mechanism340, which will be discussed in greater detail below. In one embodiment, as illustrated inFIGS. 15-23, thebase member310 may include, for example, twoholes318. Theholes318 may be of the type described above with reference toholes118 ofimplant100 and for brevity sake will not be described again here. Thebase member310 may also include at least onepivot cylinder324, at least onehinge channel326, and at least oneopening328. The at least onepivot cylinder324 and the at least onehinge channel326 may alternate as depicted inFIGS. 18 and 19.
• As seen inFIGS. 18 and 20, the top orsuperior member330 also includes anundersurface332 with at least onerelief area334 that is adjacent to thecentral opening302. Thecentral opening302 may be configured to permit the insertion of bone graft material into the inner cavity of theimplant300 prior to or after implantation. In one embodiment, as illustrated inFIGS. 15-23, thetop member330 may include, for example, tworelief areas334 which may be of the type described above with reference torelief areas134 and for brevity sake will not be described again here.
• As seen inFIGS. 18-20, therelief areas334 may be configured to mate with at least one correspondingly shapedload head370 of theexpansion mechanisms340. Thetop member330 may also include at least onehinge channel336 and at least onepivot cylinder338 and thehinge channels336 may alternate with thepivot cylinders338, as depicted inFIG. 20. The at least onehinge channel336 may mate with the at least onepivot cylinder324 of thebase member310 and the at least onepivot cylinder338 may mate with the at least onehinge channel326 of thebase member310 to enable theimplant300 to extend on a firstlateral side306 while remaining closed on a secondlateral side308. Apin339 may be inserted intoopenings325,337 in thepivot cylinders324,338, respectively, to pivotally secure thetop member330 to thebase member310. Thepivot cylinders324 and hingechannels326 of thebase member310 and thehinge channels336 andpivot cylinders338 of thetop member330 allow thehinge channels326,336 to pivot or rotate around the outer diameter of thepivot cylinders324,338 when the at least oneexpansion assembly342 is extended or retracted causing thetop member330 to tilt or slant relative to thebase member330. In another embodiment, thebase member310 may include apivot cylinder324 and thetop member330 may include ahinge channel336, alternatively, thebase member310 may include ahinge channel326 and thetop member330 may include apivot cylinder338.
• Referring now toFIG. 18 with continued reference toFIGS. 19 and 20, an exploded view of all of the components that comprise theimplant300 is shown. As shown inFIG. 21, the twoexpansion mechanisms340 of theimplant300 include anexpansion assembly342 and adrive rod380. Theexpansion assemblies342 may include acylindrical gear350, a support means358, a threadedrod360, and aload head370. The vertical cylinder orcylindrical gears350 may be of the type described above with reference tocylindrical gears150 ofimplant100 and for brevity sake will not be described again here.
• As shown inFIG. 22, the support means358 may sit on theshoulders320 of thebase member310 and function to maintain theexpansion assemblies342 in a vertical orientation relative to thebase member310 and aligned with theholes318. The support means358 may also be used adjacent to thegears350 and threadedrods360 and may hold thegears350 in theholes318. The support means358 may be of the type described above with reference to support means158 ofimplant100 and for brevity sake will not be described again here. Theshoulders320 may also operate as bearing surfaces against which the support means358 contacts to facilitate the rotation of theexpansion assemblies342 when actuated.
• As shown inFIGS. 18, 21 and 22, the threadedrods360 may be of the type described above with reference to the threadedrods160 of theimplant100 and for brevity sake will not be described again here. Thepivot cylinder362 of the threadedrods360 may be inserted into adistal channel372 of the load heads370. These constructs allow the load heads370 to pivot, slide, or rotate around the outer diameter of thepivot cylinders362 when the threadedrods360 are extended causing thetop member330 to tilt or slant. Tilted or slanted load heads370 are shown inFIGS. 17 and 22. The load heads370 may be of the type described above with reference to loadheads170 of theimplant100 and for brevity sake will not be described again here. Thereliefs334 in theundersurface332 and the correspondingly shaped load heads370 facilitate the angulation process and the load transfer between thetop member330 and thebase member310 while avoiding potential binding of theexpansion assemblies342 during the expansion and retraction process.
• Thedrive rods380 of theexpansion mechanisms340 may be inserted into theadjustment openings316 and sit in thechannel322 of thebase member310, as shown inFIGS. 18, 21, and 22. Eachdrive rod380 may include aworm gear382 and acylindrical shaft386. Theworm gear382 may also have atool opening388 in an end of thecylindrical shafts386 for coupling with atool400. In addition, thecylindrical shafts386 may include a channel376 for mating with apin390 to secure thedrive rods380 in thebase member310 to enable adjustment of thetop member330 without thedrive rod380 backing out of theimplant300. Thepin390 may also prevent thedrive rod380 from backing out of theimplant300 after implantation into the patient's spine (SeeFIG. 23). By placing theadjustment openings316 and thechannels322 in a side of theimplant300, the worm gears382 of thedrive rods380, which are inserted into thechannels322, intersect with theholes318 of thebase member310. The worm gears382 may be configured to engage with thegears350 of theexpansion assemblies342 which sit in theholes318 of thebase member310.FIG. 22 shows the assembledimplant300 without thetop member330 with thedrive rods380 positioned offset from the lateral axis and extending laterally into thebase member310.
• When theimplant300 is inserted into apatient using tool400, as shown inFIG. 24, thetool400 engages thealignment opening312, theattachment opening314 and theadjustment openings316, as described in greater detail below. Once theimplant300 is inserted into the patient between two vertebrae using thetool400, thedrive rods380 with thegears350 function to mirror the rotational movement exerted by thetool400, described in greater detail below, and translate the movement to thegears350. Theexpansion mechanisms340 function to convert rotation movement of thegears350 into linear or translational movement of the load heads370 positioned at the superior end of the threadedrods360. Rotation of thegears350 will result in a travel distance of the threadedrods360 when theexpansion mechanisms340 are actuated by thetool400. As thegears350 are coupled to thedrive rods380, the coupled gears350 will turn as thedrive rod380 is rotated.
• With continued reference toFIGS. 15-23, as thedrive rods380 are rotated by thetool400 the teeth378 of the worm gears382 of thedrive rods380 are configured to mate with the substantiallyvertical depressions352 of thegears350. As described above, theexpansion assemblies342 act to covert rotational movement of thegears350 into translational movement of the threadedrods360. This is achieved by allowing free rotational movement of thegears350 while restricting the rotation of the threadedrods360. By restricting the rotation of the threadedrods360, the rods translate in either an upward or downward direction relative to thegears350 depending upon whether the threads (external and internal)354,364 are oriented in a right-handed or left-handed direction. As discussed above, when the threadedrods360 move, the load heads370 contact therelief areas334 of theundersurface332 of thetop member330 to either move it away from or towards thebase member310. In other words, thebone contacting surface304 of thetop member330 will be angled relative to thebase member310 depending on the rotational direction of thetool400. Locking mechanisms, for example, thelocking mechanism192 ofFIG. 10, which will not be described again here for brevity sake, may be inserted intoadjustment openings316 to secure theimplant100 in the desired expansion or refraction.
• Referring now toFIGS. 24-35, atool400 for inserting theimplant300 into a patient is shown. Thetool400 is designed to engage theexpansion mechanisms340. Theinsertion end402 of thetool400 may be configured with ahousing404 including aprotrusion406 shaped to correspond to thealignment opening312 in thebase member310. Theinsertion end402 may also include at least oneadjustment mechanism408 and asecurement mechanism410 which protrude out of the distal end of thehousing404. Theadjustment mechanisms408 may be configured, for example, to have a hex male head, square, or other multi-lobed configuration that will allow for the user to rotate theknob424 of thetool400 and cause theexpansion mechanisms340 to rotate. Thesecurement mechanism410 may be configured, for example, to include threads for engaging corresponding threads in theattachment opening314.
• Opposite theinsertion end402, thetool400 has ahandle412 which may be connected to thehousing404 of theinsertion end402 by at least onetube414. In one embodiment, there are threetubes414, acenter tube414 for thesecurement mechanism410 and twolateral tubes414 for theadjustment mechanisms408. The at least onetube414 may be coupled to thehousing404 on the distal end and secured to anattachment member420 which couples to thehandle412 at the proximal end by fasteners, for example, screws. Thesecurement mechanism410 may extend from thehandle412 to thehousing404 inside thecenter tube414. In addition, theadjustment mechanisms408 may also extend between thehousing404 and thehandle412 inside thetubes414 adjacent to thecenter tube414 with thesecurement mechanism410.
• As seen inFIGS. 27-29, thehandle412 of thetool400 may also include afirst opening416 along the longitudinal axis of thehandle412 and asecond opening418 extending into thehandle412 from the distal end. Thehandle412 may also include afirst knob422 and asecond knob424. Thefirst knob422 may engage thesecurement mechanism410 at a proximal end and the distal end of thesecurement mechanism410 may be inserted into theopening416 in thehandle412. Thesecond knob424 may engage anattachment member420 which in turn may be inserted into a portion of thehandle412 throughopening418. Theattachment member420 may include twogrooves432,434, eachgroove432,434 mates with twogears450 and twospring mechanisms446. Thegears450 may fit into thegrooves432,434 and aspring446 may sit on the proximal end of thegears450, theknob424 may fit over thesprings446 and gears450 to couple the exterior grooves of thegears450 with the interior grooves of theknob424. Theattachment member420 may then be inserted into thehandle412 and secured. Theadjustment mechanisms408 may engage the distal end of thegears450 to enable rotation of theadjustment mechanisms408 by rotating theknob424.
• During use a surgeon may insert thetool400 into theimplant300 by aligning theprotrusion406 of theinsertion end402 of thetool400 with thealignment opening312 of theimplant300. Once thetool400 andimplant300 are aligned, thesecurement mechanism410 may be coupled at a proximal end to theknob422. Thesecurement mechanism410 may then be inserted into theopening416. Thesecurement mechanism410 may be advanced through thehandle412, theattachment member420, and thetube414 until the distal end of thesecurement mechanism410 extends out of thehousing404. Theknob422 of thetool400 may be rotated which in turn will rotate thesecurement mechanism410. As theknob422 rotates thesecurement mechanism410, the distal end of thesecurement mechanism210 engages thethreads308 of the attachment opening314 of theimplant300. Thesecurement mechanism410 of the tool will couple with the attachment opening314 of theimplant300 to secure theimplant300 to thetool400 for insertion into a patient. In addition, as thesecurement mechanism410 engages the attachment opening314 of theimplant300, theadjustment mechanisms408 of the tool will engage theopenings386 in thedrive rods380 of theimplant300.
• Once theimplant300 is secured to thetool400, theimplant300 may then be inserted into the desired position in the patient. The physician may then rotate theknob424 which in turn will rotate the distal ends of theadjustment mechanisms208. As theknob424 is rotated, theadjustment mechanisms408, which are coupled to theopenings386 in thedrive rods380, engages theexpansion mechanisms340 and expands the near side of theimplant300 to angle thetop member330 relative to thebase member310. The cogs or teeth378 of the worm gears384 on the end of thedrive rods380 are sized to mate with the correspondingserial depressions352 of thegears350 to facilitate rotation of thegears350 when theknob424 of thetool400 is turned. Once the desired expansion of theimplant300 is achieved, thetool400 may then be removed from the patient.
• Thetool400 may be removed from the patient by rotating theknob422 to disengage the distal end of thesecurement mechanism410 from the attachment opening314 of theimplant300. As thesecurement mechanism410 rotates it disengages theattachment opening314 and theprotrusion406 and theadjustment mechanisms408 of theinsertion end402 of thetool400 may slide out of thealignment opening412 andadjustment openings416, respectively. After thetool400 is removed from theimplant300, locking mechanisms, for example,locking mechanism192 as shown inFIG. 10 may be inserted into theopenings316 to lock theimplant300 in the desired expansion or refraction. It is also contemplated that the above method for inserting theimplant300 usingtool400 may be performed in alternative orders.
• Referring now toFIGS. 36-38, an adjustableinterbody fusion device500, is shown and includes abase member510, at least one moveabletop member530, and at least oneexpansion mechanism540. Thedevice500 is of the type described in U.S. Application No. 61/756,048 filed Jan. 24, 2013, which is herein incorporated by reference in its entirety. An alternativeembodiment hinge mechanism506 including at least onepivot cylinder524 and at least onehinge channel536 is shown inFIGS. 36-38. As shown, thehinge mechanism506 includes at least onepivot cylinder524 and at least onehinge channel536 in thebase member510 and at least onepivot cylinder524 and at least onehinge channel536 in thetop member530. The at least onehinge channel536 of thetop member530 may mate with the at least onepivot cylinder524 of thebase member510 and the at least onepivot cylinder524 of thetop member530 may mate with the at least onehinge channel536 of thebase member510 to enable theimplant500 to extend on a far end while remaining closed on a near end. Apin539 may be inserted intoopenings525 in thepivot cylinders524, to pivotally secure thetop member530 to thebase member510. Thepivot cylinders524 and hingechannels536 of thebase member510 and thehinge channels536 andpivot cylinders524 of thetop member530 allow thehinge channels536 to pivot or rotate around the outer diameter of thepivot cylinders524 when the at least oneexpansion assembly542 is extended or retracted causing thetop member530 to tilt or slant relative to thebase member530. Theexpansion mechanism540 of theimplant500 includes at least oneexpansion assembly542 and adrive rod580. Theexpansion assembly542 may include acylindrical gear550, a support means558, a threadedrod560, and aload head570. Thecylindrical gear550, support means558, threadedrod560, andload head570 are of the type described above with reference toimplants100 and300. Alocking mechanism192, of the type described above with reference toFIG. 10, may be inserted into opening in thedrive rod580 to secure theexpansion assembly542 in place to maintain a desired expansion or retraction of theimplant500.
• Referring now toFIGS. 39-41, an adjustableinterbody fusion device600, is shown and includes abase member610, at least one moveabletop member630, and anexpansion mechanism640. Thebase member610 may be of the type described above with reference tobase member110 which will not be described again here for brevity sake. As shown inFIG. 39, the expansion mechanism ormovement mechanism640 allows a user to angle or raise one side of thebone contacting surface104 of thetop member630 relative to thebone contacting surface104 of thebase member610, wherein the near side is expanded and the far side remains engaged or hinged. Thebone contacting surfaces104 of thedevice600 are the same as thebone contacting surfaces104 as described above with reference todevice100, which will not be described again here for brevity sake.
• The top orsuperior member630, as shown inFIGS. 39-41, may be similar to thetop member130 as described in greater detail above and only the changed features will be described here for brevity sake. Thetop member630 may include at least onerelief area134 on theundersurface132 of thetop member630, as described above with reference toFIGS. 4 and 6. In the depicted embodiment there are tworelief areas134, although onerelief area134 and more than tworelief areas134 are also contemplated. Therelief areas134 may extend from an intermediate position on theundersurface132 of thetop member630 to at least one outer side of thetop member630. As shown inFIGS. 39-41, the at least onerelief area134 may also include at least onestop pin634. Thestop pin634 may be positioned closer to the firstlateral side106 than to the secondlateral side108 of therelief area134 on theundersurface132 of thetop member630. Thestop pin634 may be an integral portion of thetop member630 or alternatively, thestop pin634 may be removable. If aremovable stop pin634 is used therelief areas134 may each include an opening (not shown) for receiving thestop pin634. Aremovable stop pin634 may be secured into the opening (not shown) on theundersurface132 of thetop member630 by, for example, threads, an adhesive, press-fitting, and the like. Thestop pin634 may protrude or extend out from a surface of therelief area134 to engage aload head670, which will be described in greater detail below, and prevent it from sliding out of therelief area134.
• Theexpansion mechanism640 of theimplant600, as shown inFIG. 40, may include at least oneexpansion assembly642 and adrive rod180. Theexpansion assemblies642 may include acylindrical gear150, a support means158, a threadedrod160, and aload head670. Thecylindrical gear150, support means158, and threadedrod160 may be of the type described above with reference todevice100 and will not be described again here for brevity sake. Theload head670 may be similar to loadhead170 as described above with reference todevice100. Theload head670 may include adistal channel672 which may receive thepivot cylinder162 of the threadedrods160. The load heads670 may also include superior head surfaces674 that may be shaped to mate with the correspondingrelief areas134 on theundersurface132 of thetop member630. The superior head surfaces674 may also include acutout676 shaped to receive the stop pins634. When the load heads670 are positioned in therelief areas134, thecutout676 may be positioned toward the firstlateral side106 of thetop member630. The superior head surfaces674 are configured to slide within thereliefs134 of theundersurface132, if necessary, to allow theexpansion assemblies642 to lengthen to create the angled relationship of thetop member630 relative to thebase member610. The stop pins634 are positioned in therelief areas134 to engage thecutouts676 in the load heads670 to prevent the load heads670 from sliding out of therelief areas134 while thetop member630 is expanded or retracted relative to thebase member610. Thecutouts676 may have, for example, a relatively circular shape to correspond to the circular shape of the stop pins634, although alternative shapes for thecutouts676 and stoppins634 are also contemplated.
• Thedrive rod180 of theexpansion mechanism140, as shown inFIG. 40, may include at least oneworm gear682 and acylindrical shaft186. Thecylindrical shaft186 may be of the type described above with reference todevice100 and which will not be described again here for brevity sake. The at least oneworm gear682 may be similar to the worm gears182 and184 as described above with reference todevice100 and only the differences will be described here for brevity sake. Theworm gear682 ofdevice600 will have a length essentially the same size as the combined length of worm gears182,184. The length of theworm gear682 will enable engagement with bothgears150 of theexpansion assemblies142 simultaneously. Theworm gear682 may be a monolithic rod that extends along the length of thebottom member610. In an alternative embodiment, thedrive rod180 may be a monolithic rod extending along the length of thebottom member610 inchannel122.
• The stop pins634 may also be used in thetop members130,330 of thedevices100,300 shown inFIGS. 4 and 18. In addition,cutouts676 may be formed in the load heads170,370 of thedevices100,300 to receive the stop pins634 of thetop members130,330. Further, if thetop member530 ofdevice500, as shown inFIG. 38, was altered such that the relief area oftop member530 extended all the way to the side of thedevice500, then astop pin634 may be used in thetop member530 along with acutout676 in theload head570 to prevent theload head570 from sliding out of the relief area of thetop member530 as thetop member530 is tilted relative to thebase member510.
• A surgical method for maintaining a space between two vertebral bodies in a spine may include: obtaining amedical device100,300,500,600. Themedical device100,300,500,600 including abody member110,310,510,610 with at least onepivot cylinder124,324,524 and at least onehinge channel126,326,536, amoveable member130,330,530,630 with at least onepivot cylinder138,324,524 and at least onehinge channel136,326,536, wherein the at least onepivot cylinder124,324,524 of thebody member110,310,510,610 engages the at least onehinge channel136,326,536 of themoveable member130,330,530,630 and the at least onepivot cylinder138,324,524 of themoveable member130,330,530,630 engages the at least onehinge channel126,326,536 of thebody member110,310,510,610, and at least onemovement mechanism140,340,542,640 engaging themoveable member130,330,530,630 and the body member. The method also including inserting and coupling a tool into at least two openings within themedical device100,300,500,600, slidingly inserting themedical device100,300,500,600 into a space between two vertebral bodies, and adjusting the tool to move a first side of themoveable member130,330,530,630 in a vertical direction relative to thebody member110,310,510,610. Coupling the tool into at least two openings within themedical device100,300,500,600 may include securing the securement mechanism into the at least two openings in themedical device100,300,500,600. Adjusting the tool to move the first side of themoveable member130,330,530,630 in a vertical direction relative to thebody member110,310,510,610 may include turning the at least one second knob to actuate the at least onemovement mechanism140,340,542,640 to move the first side of themoveable member130,330,530,630 in a vertical direction relative to thebody member110,310,510,610.
• The tool may include a handle, an insertion end, at least one tube extending distally away from the handle and connecting the handle and the insertion end, a securement mechanism coupled to the handle, extending through the at least one tube and protruding from the insertion end, at least one adjustment mechanism coupled to the handle, extending through the at least one tube and protruding from the insertion end, a first knob for actuating the securement mechanism, and at least one second knob for actuating the at least one adjustment mechanism.
• The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.
• Although the example embodiments have been depicted and described in detail herein, it will be apparent to those skilled in the relevant art that various modifications, additions and substitutions can be made without departing from its essence and therefore these are to be considered to be within the scope of the following claims.

Claims (20)

What is claimed is:

1. An insertion tool, the insertion tool comprising:

a handle;

a housing coupled to and extending away from the handle;

a securement mechanism with at least a portion of the securement mechanism positioned on a first end of the housing;

at least one adjustment mechanism inserted into the handle at a second end, extending through the handle and the housing, and protruding from the first end of the housing; and

an actuation bar coupled to and moveable relative to the handle, wherein the actuation bar engages the at least one adjustment mechanism to maintain a position of the at least one adjustment mechanism relative to the first end of the housing.

2. The insertion tool ofclaim 1, further comprising:

at least one knob coupled to the at least one adjustment mechanism for actuating the at least one adjustment mechanism.

3. The insertion tool ofclaim 2, wherein the at least one knob comprises:

a first knob for fine adjustment of the at least one adjustment mechanism; and

a second knob for coarse adjustment of the at least one adjustment mechanism.

4. The insertion tool ofclaim 3, wherein the first knob comprises:

a shaft with a first end and a second end; and

a head coupled to the first end of the shaft;

wherein the shaft extends from a second end of the handle, through at least a portion of the handle to engage the adjustment mechanism.

5. The insertion tool ofclaim 4, wherein the head of the first knob has a first diameter, wherein the second knob has a second diameter, and wherein the first diameter is larger than the second diameter.

6. The insertion tool ofclaim 2, further comprising:

a third knob coupled to the securement mechanism, wherein the third knob rotates to actuate the securement mechanism.

7. The insertion tool ofclaim 6, wherein the third knob has a threaded end.

8. The insertion tool ofclaim 6, wherein the third knob is positioned at a first end of the handle and the at least on knob is positioned at a second end of the handle.

9. The insertion tool ofclaim 4, wherein the shaft of the first knob includes at least one indicator.

10. The insertion tool ofclaim 1, wherein the at least one adjustment mechanism comprises an engagement end at a first end.

11. The insertion tool ofclaim 10, wherein the engagement end has a multi-lobed shape.

12. The insertion tool ofclaim 1, wherein the securement mechanism is moveably coupled to the handle and protruding from a first end of the housing.

13. The insertion tool ofclaim 1, wherein the handle comprises:

a first opening extending from a first end of the handle to a second end of the handle along a longitudinal axis of the handle, the first opening receives at least a portion of the at least one adjustment mechanism; and

a second opening extending from a first exterior surface of the handle to a second opposite exterior surface of the handle, wherein the second opening extends perpendicular to the first opening,

wherein a portion of the second opening engages a portion of the first opening.

14. The insertion tool ofclaim 1, wherein a first end of the housing comprises an engagement protrusion for engaging an implant.

15. The insertion tool ofclaim 1, wherein the actuation bar is moveable between at least one first locked position and a second translation position.

16. The insertion tool ofclaim 15, wherein the actuation bar comprises:

a hole extending from a first side to a second side of the actuation bar, wherein the hole receives a portion of the adjustment mechanism.

17. The insertion tool ofclaim 15, wherein the at least one first locked position is multiple first locked positions that allow for the adjustment mechanism to extend from the first end of the housing at different lengths.

18. A method of using an insertion tool, comprising:

providing an implant;

providing an insertion instrument;

inserting an adjustment mechanism into the insertion instrument; and

coupling the implant to the insertion instrument.

19. The method ofclaim 18, wherein coupling the implant to the insertion instrument comprises:

engaging a securement mechanism at the first end of the insertion instrument with an opening in the implant.

20. The method ofclaim 19, further comprising:

adjusting a dimension of the implant by rotating the adjustment mechanism, wherein adjusting a dimension of the implant comprises moving at least one side of the implant in a vertical direction.

Images