US20130325071A1 - Aligning Vertebral Bodies - Google Patents

Abstract

Misaligned bones on opposite sides of a joint are aligned using a first rigid extension securable to one of the misaligned bones using a particular surgical approach, and a second rigid extension having a contacting surface positionable in contact with the other the two misaligned bones from the same surgical approach. The first and second rigid extensions are moved with respect to each other using a lever, whereby a pulling force is exerted on one of the bones, and a pushing force on the other, thereby aligning the first and second misaligned bones.

Description

FIELD OF THE INVENTION
• The invention relates to aligning bones of the body, and more particularly to reducing adjacent vertebrae and realigning the vertebral column, for example to correct spondylolisthesis.
BACKGROUND OF THE INVENTION
• Bones, bony structures and tissue are susceptible to a variety of weaknesses that can affect their ability to provide support and structure. Weaknesses in bony structures may have many causes, including degenerative diseases, tumors, fractures, and dislocations. Advances in medicine and engineering have provided doctors with a plurality of devices and techniques for alleviating or curing these weaknesses.
• In some cases, an anterior or posterior displacement of a vertebra with respect to an adjacent vertebra takes place, giving rise to a disorder termed spondylolisthesis. Resultant pressure on nerves can produce pain, stiffening of the back, changes in gait, and muscular atrophy, for example.
• Conservative approaches may include physical therapy and treatment with NSAIDs such as acetaminopyhen. Spinal decompression through, for example, laminectomy or non-surgical methods may be employed. Additionally, a fusion may be carried out, for example a posterolateral fusion of adjacent vertebrae.
SUMMARY OF THE INVENTION
• In accordance with the disclosure, a device for therapeutically aligning two misaligned vertebral bodies on opposite sides of a joint, comprises a first rigid extension securable to a first of the misaligned bones using a single approach selected from the group consisting of left lateral approach, right lateral approach, anterior approach, and posterior approach; a second rigid extension having a contacting surface positionable in contact with the second of the two misaligned bones from the approach selected for securing the first rigid extension, the second rigid extension moveable with respect to the first rigid extension when the first rigid extension is secured to the first of the misaligned bones and the second rigid extension is positioned in contact with the second of the two misaligned bones; and a lever configured to lever the first rigid extension with respect to the second rigid extension to move the first rigid extension with respect to the second rigid extension, to thereby exert a pulling force on the first of the two misaligned bones, and a pushing force on the second of the two misaligned bones, aligning the first and second misaligned bones.
• In embodiments thereof, the first and second misaligned bones are vertebrae; the device further includes an intervertebral spacer, the first rigid extension securable to the intervertebral spacer, the intervertebral spacer connected to the first of the misaligned bones; and the intervertebral spacer is formed in two segments, each segment attachable to one of the first or second misaligned bones, the segments moveable with respect to each other when attached to a respective misaligned bone.
• In other embodiments thereof, the segments moveable in ratcheting engagement with respect to each other; the lever applies leverage using a rotatable thread; the first rigid extension is securable to the misaligned bone using a threaded fastener; the first rigid extension is a plate; the plate forms a levered connection between the first and second misaligned bones; the first rigid extension extends around the first misaligned bone to contact a portion of the first misaligned bone which faces an approach different from the approach selected; and one of the first or second misaligned bones is the sacrum.
• In yet further embodiments thereof, the lever is a screw having threads configured to engage bone on a first end, and threads configured to engage a nut on a second, opposite end, the nut rotated about the second end moves the second rigid extension and to thereby lever the first and second misaligned bones into alignment; the device further includes an intervertebral spacer; and the intervertebral spacer is expandable to increase a distance between the first and second misaligned bones.
• In another embodiment of the disclosure, a device for therapeutically aligning two vertebrae, comprises a first rigid extension securable to a first of the vertebrae using a single approach selected from the group consisting of left lateral approach, right lateral approach, anterior approach, and posterior approach; a second rigid extension having a contacting surface positionable in contact with the second of the two vertebrae from the approach selected for securing the first rigid extension, the second rigid extension moveable with respect to the first rigid extension when the first rigid extension is secured to the first of the vertebrae and the second rigid extension is positioned in contact with the second of the two vertebrae; a lever configured to lever the first rigid extension with respect to the second rigid extension to move the first rigid extension with respect to the second rigid extension, to thereby exert a pulling force on the first of the two vertebrae, and a pushing force on the second of the two vertebrae, aligning the first and second vertebrae; and a fastener configured to maintain the first and second vertebrae in relative alignment.
• In embodiments thereof, the device further includes an intervertebral spacer connectable to at least one of the first and second rigid extensions during alignment of the vertebrae, and connectable to both vertebrae to maintain the vertebrae in relative alignment; and the first rigid extension forming a first portion of an intervertebral spacer, the second rigid extension forming a second portion of an intervertebral spacer, the first and second portions mateably engageable and maintainable in relative mutual engagement using a ratchet.
• In a further embodiment of the disclosure, a method for therapeutically aligning two misaligned bones on opposite sides of a joint, comprises securing a first rigid extension to a first of the misaligned bones using a single approach selected from the group consisting of left lateral approach, right lateral approach, anterior approach, and posterior approach; contacting the second of the misaligned bones with a second rigid extension, the second rigid extension having a contacting surface positionable in contact with the second of the two misaligned bones from the approach selected for securing the first rigid extension, the second rigid extension moveable with respect to the first rigid extension when the first rigid extension is secured to the first of the misaligned bones and the second rigid extension is positioned in contact with the second of the two misaligned bones; and levering the first rigid extension with respect to the second rigid extension using a lever configured to move the first rigid extension with respect to the second rigid extension, to thereby exert a pulling force on the first of the two misaligned bones, and a pushing force on the second of the two misaligned bones, aligning the first and second misaligned bones.
• In embodiments thereof, the method further includes inserting an intervertebral spacer between the two misaligned bones; and further includes connecting the intervertebral spacer to the first of the misaligned bones; and applying the lever between the intervertebral spacer and the second of the misaligned bones.
BRIEF DESCRIPTION OF THE DRAWINGS
• A more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:
• FIG. 1 is a diagram of a joint of a body;
• FIG. 2 is a diagram of the joint ofFIG. 1, misaligned;
• FIG. 3 is a diagram of the joint ofFIG. 1, and a cross-section of a connected plate and spacer of the disclosure;
• FIG. 4 depicts the joint ofFIG. 1, aligned using the plate and spacer ofFIG. 3;
• FIG. 5A depicts the joint ofFIG. 1, and a cross section of a spacer, plate, and tool of the disclosure
• FIG. 5B is a diagram of the joint ofFIG. 1, the joint having been aligned using the spacer, plate, and tool ofFIG. 5A;
• FIG. 6 is a diagram of the joint ofFIG. 1, and the spacer and plate ofFIG. 5B secured to the joint using fasteners, from a cross-section;
• FIG. 7 is a diagram of the joint ofFIG. 1, and a top view of a reaching tool and plate of the disclosure;
• FIG. 8 depicts the joint and device ofFIG. 7, in a cross-section;
• FIG. 9 depicts the joint and device ofFIG. 8, the joint aligned using the device ofFIG. 8;
• FIG. 10 is a diagram of the joint ofFIG. 1, and a cross-section of spacer of the disclosure having two ratcheting segments;
• FIG. 11 depicts the joint and device ofFIG. 10, the joint aligned by the device ofFIG. 10;
• FIG. 12 is a cross-section of a segmented spacer of the disclosure;
• FIG. 13 depicts the spacer ofFIG. 12, the segments mutually secured by a fastener;
• FIG. 14 is a diagram of the joint ofFIG. 1, a cross-section of a ratcheting spacer of the disclosure, and an indication of an application of a force to align the joint;
• FIG. 15 is a diagram of the joint ofFIG. 1, and a spacer of the disclosure, and an indication of an application of a force to align the joint;
• FIG. 16 is a diagram of the joint ofFIG. 1, and a cross-section of a spacer and tool in accordance with the disclosure;
• FIG. 17 depicts the joint and device ofFIG. 16, the device having aligned the joint;
• FIG. 18 depicts the joint and spacer ofFIG. 17, the spacer secured to the aligned joint;
• FIG. 19 is a diagram of the joint ofFIG. 1, and a cross-section of a spacer and tool of the disclosure;
• FIG. 20 is a diagram of the joint ofFIG. 1, and a reaching plate of the disclosure;
• FIG. 21 is a diagram of the joint ofFIG. 1, and a hinged plate and lever of the disclosure;
• FIG. 22 is a diagram of the joint ofFIG. 1, and a segmented spacer and lever of the disclosure;
• FIG. 23 is a diagram of the joint and device ofFIG. 22, the joint having been aligned by applying the lever to the device;
• FIG. 24 depicts the joint and device ofFIG. 23, the joint having been aligned by applying the lever to a segment and to the joint;
• FIG. 25 depicts the joint and device ofFIG. 24, the segments joined by a fastener;
• FIG. 26 is a diagram of the joint ofFIG. 1, and a cross-section of a spacer and plate of the disclosure;
• FIG. 27 depicts the joint and spacer ofFIG. 26, the joint having been aligned by the plate, and the spacer secured to both sides of the joint using fasteners;
• FIG. 28 is a diagram of the joint ofFIG. 1, and a spacer of the disclosure;
• FIG. 29 depicts the spacer and joint ofFIG. 28, the joint having been aligned by the spacer;
• FIG. 30 is a diagram of the joint and spacer ofFIG. 28, and a cross-section of a plate of the disclosure, the spacer and plate cooperative to align the joint;
• FIG. 31 depicts a joint of the body, in this example the L5 and S1 vertebrae, and a cross-section of a plate of the disclosure connected to both vertebrae;
• FIG. 32 depicts the joint ofFIG. 31, aligned by the plate, the plate further secured to the joint;
• FIG. 33 is a diagram of the joint ofFIG. 31, and a cross-section of a plate and fastener of the disclosure;
• FIG. 34 depicts the joint and device ofFIG. 33, the joint having been aligned by the device, the fastener shortened after use;
• FIG. 35 is a diagram of the joint ofFIG. 1, and a fastener of the disclosure;
• FIG. 36 depicts the joint and fastener ofFIG. 35, the joint having been aligned by the fastener;
• FIG. 37 is a diagram of the joint ofFIG. 1, and a ratcheting device of the disclosure connected to each side of the joint;
• FIG. 38 depicts the joint and device ofFIG. 37, the joint having been aligned by the device;
• FIG. 39 is a diagram of the joint ofFIG. 1, and a cross-section of a segmented spacer of the disclosure;
• FIG. 40 depicts the joint and spacer ofFIG. 39, the joint secured in alignment, and distracted, using the device ofFIG. 39;
• FIG. 41 is a diagram of the joint ofFIG. 1, and a cross-section of a segmented spacer having three mateable portions, including opposed segments and a wedge shaped spacer;
• FIG. 42 depicts the joint and device ofFIG. 41, the spacer having been inserted between the opposed segments, and the joint, opposed segments, and spacer maintained in alignment by fasteners and a mating engagement between the opposed segments and the spacer;
• FIG. 43 depicts the joint and device ofFIG. 40, the opposed segments shaped to reduce an angle formed between bones of the joint;
• FIG. 44 depicts the joint and device ofFIG. 40, the opposed segments shaped to increase an angle formed between bones of the joint;
• FIG. 45 depicts a diagram of the joint ofFIG. 1, and an expandable spacer, plate, and reaching tool of the disclosure;
• FIG. 46 depicts the spacer and device ofFIG. 45 in an expanded configuration, distracting bones of the joint, the joint having been aligned by the spacer, plate, and reaching tool;
• FIG. 47 is a diagram of the joint ofFIG. 1, and a cross-section of a spacer, angled plate, and fastener of the disclosure;
• FIG. 48 depicts the joint and device ofFIG. 47, the joint having been aligned using the device, the fastener having been shortened after use;
• FIG. 49 is a diagram of the joint ofFIG. 1, and a cross-section of spacer, integrated plate, and fastener of the disclosure;
• FIG. 50 depicts the joint and device ofFIG. 49, the joint having been aligned by the device, the fastener shortened after use;
• FIG. 51 is a diagram of the joint ofFIG. 1, a cross-section of a spacer of the disclosure with ramped segments, and an indication of an application of force to align the joint;
• FIG. 52 depicts the joint and spacer ofFIG. 51, the joint having been aligned using the spacer, the spacer segments fastened together after alignment;
• FIG. 53 is a diagram of the joint ofFIG. 1, and a cross-section of an adjustable segmented spacer of the disclosure, the spacer including a rotatable screw operative to align the segments;
• FIG. 54 depicts the joint and spacer ofFIG. 53, the joint having been aligned using the spacer, the segments of the spacer fixed by a fastener;
• FIG. 55 is a side view of a combined plate, spacer, and fasteners of the disclosure;
• FIG. 56 is a perspective view from the top of the device ofFIG. 55;
• FIG. 57 is a side view of an alternative combined plate, spacer and fasteners of the disclosure;
• FIG. 58 is top perspective view from the top of the device ofFIG. 57;
• FIG. 59 is an alternate top perspective view from the top of the device ofFIG. 57;
• FIG. 60 is a side view of a mateable plate and spacer of the disclosure;
• FIG. 61 is a perspective view of the device ofFIG. 60;
• FIG. 62 is a side view of the device ofFIG. 60, the plate and spacer mutually assembled in conforming relationship;
• FIG. 63 is a front perspective view of a combined plate and spacer of the disclosure;
• FIG. 64 is a front perspective view of a combined plate and spacer of the disclosure, the plate provided with a shaped projection;
• FIG. 65 is a perspective illustration of spacer of the disclosure formed of mateable segments;
• FIG. 66 is a perspective view of the spacer ofFIG. 65, the segments mated;
• FIG. 67 is a top view of the device ofFIG. 65;
• FIG. 68 is a top view of the device ofFIG. 66;
• FIG. 69 is a back view of a combined spacer and plate in two segments, the segments slidingly engageable along an A-P axis;
• FIG. 70 is a side view of the device ofFIG. 69, the segments partially slidingly engaged;
• FIG. 71 is a perspective view of the device ofFIG. 70;
• FIG. 72 is a side view of a combined spacer and plate in two segments, the segments slidingly engageable along a lateral axis;
• FIG. 73 is a perspective view of the device ofFIG. 72;
• FIG. 74 is a side view of a combinable spacer, plate, and fasteners of the disclosure, the plate provided with a shaped projection, the fasteners disposed at an angle;
• FIG. 75 is a side view of a combinable spacer, plate, and fasteners of the disclosure, the plate provided without the shaped projection illustrated inFIG. 74, the fasteners disposed at an angle;
• FIG. 76 is a bottom perspective view of a combinable spacer, plate, and fasteners of the disclosure, the plate provided with a shaped projection, the fasteners disposed at a converging angle;
• FIG. 77 is a top perspective view of the device ofFIG. 76;
• FIG. 78 is a front view of the device ofFIG. 74, illustrating locking pins;
• FIG. 79 is a side view of the device ofFIG. 74, implanted within a spine;
• FIG. 80 is an illustration of an insertion and alignment tool in accordance with the disclosure;
• FIG. 81 depicts a side view of the tool ofFIG. 80 gripping the device ofFIG. 74;
• FIG. 82 depicts the tool and device ofFIG. 81, the tool having inserted the device into a spine, the device fastened to the S1 vertebra;
• FIG. 83 depicts the tool and device ofFIG. 81 having aligned vertebrae of the spine;
• FIG. 84 depicts the tool and device ofFIG. 83, the device fastened to the L5 vertebra;
• FIGS. 85A-85C depict a method of inserting a spacer in accordance with the disclosure;
• FIG. 86 depicts a side view of a combinable spacer, plate and fasteners of the disclosure, the plate provided with an upper lip; and
• FIG. 87 depicts a joint of the body, in this example the L5 and S1 vertebrae, and a cross-section of an alternative plate of the disclosure connected to both vertebrae.
DETAILED DESCRIPTION OF THE INVENTION
• As required, detailed embodiments are disclosed herein; however, it is to be understood that the disclosed embodiments are merely examples and that the systems and methods described below can be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present subject matter in virtually any appropriately detailed structure and function. Further, the terms and phrases used herein are not intended to be limiting, but rather, to provide an understandable description of the concepts.
• The terms “a” or “an”, as used herein, are defined as one or more than one. The term plurality, as used herein, is defined as two or more than two. The term another, as used herein, is defined as at least a second or more. The terms “including” and “having,” as used herein, are defined as comprising (i.e., open language).
• With reference toFIG. 1, a healthy pair ofvertebrae300,302 are diagrammatically illustrated. Although adjacent vertebrae are not identical in the body, to simplify an understanding of an operation of devices and methods of the disclosure, a centrally disposeddotted line304 represents a natural overlapping of bones. The disc annulus surrounding the nucleus pulposus is diagrammatically illustrated asdisc306, positioned in alignment with both vertebrae. InFIG. 2,vertebrae300,302 are relatively displaced, representing a patient condition addressed by the disclosure, for example degenerative fibrocartilage, malignancy, herniation, protrusion, spondylolysis, spondylolisthesis, spinal stenosis, or degenerative disc disease. While onevertebra300 appears to be oriented in an upper, or superior location with respect to theother vertebra302, it should be understood that within the body, superior, inferior, or both bones may be displaced, and that a superior or inferior position of adjacent bones should not be assumed within the disclosure. In addition, a displacement may be anterior, posterior, or lateral.
• In the various embodiments described herein, the spine and vertebrae are described as the bones to be aligned. However, it should be understood that the methods and devices of the disclosure are readily applied or adapted to be used with other bones of the body, for example in size and shape. Such other bones include the joints of the fingers, hand, wrist, elbow, shoulder, hip, knee, ankle, foot, or toes. Non-jointed tissue, such as bony plates, for example misaligned after trauma, may also be aligned as described herein. Accordingly, the disclosure should be considered in light of other bones and tissue, throughout.
• In various embodiments, the devices and methods of the disclosure provide solutions for treating diseases of the spine, for example, isthmic spondylolisthesis, from a single approach, such as advantageously an anterior approach. This avoids a requirement of an approach through two separate aspects of the body, for example also a posterior approach. This reduces trauma to the patient, recovery time, time to complete the surgical procedure, risk, and cost. While an anterior approach is possible, it should be understood that a lateral or posterior approach is similarly possible, while retaining the advantage of aligning bones of a joint from a single approach, including only one of a left lateral approach, a right lateral approach, an anterior approach, or a posterior approach.
• InFIG. 3, anintravertebral spacer5000 engages one or more fasteners, for example bone screws200, for example by passing a polyaxial screw through an aperture, not shown, or through some other configuration understood within the art. In this manner, a position ofspacer5000 may become fixed with respect to one or more vertebrae, at least for a sufficient period of time for healing and or fusion between the body and the spacer to take place, for example through bony ingrowth.Spacer5000 may be provided with spaces, channels, texture, or other structure which encourages bone ingrowth, and may further be provided with therapeutic substances which encourage bone growth.
• With further reference toFIG. 3, an assembly in accordance with the disclosure includes aplate400, fasteners or screws200,202, and anintervertebral spacer5000.Spacer5000 is secured to avertebra300 using one or more bone screws200 or other fastener. It should be understood that while abone screw200 is illustrated in the drawings, for clarity, any fastener suitable for connecting an implant to a bone may be used, including adhesive, as would be understood by one skilled in the art. In this configuration,vertebra300 is closer to the surgical approach thanvertebra302. For example, in an anterior approach,vertebra300 is shifted anteriorly with respect tovertebra302. In a lateral or posterior approach,plate400 would be applied to the more lateral or posterior vertebra, respectively.
• Plate400, in accordance with this and other embodiments of the disclosure, may have a flat, rectangular or bar shape such as is illustrated in the drawings, for clarity, or may be contoured and or curved, or shaped to closely conform, to the body tissue to which it is attached. In some embodiments, theplate400 is rigid, while in other embodiments, theplate400 can be flexible or bendable. In some embodiments, theplate400 is configured such that in an unstressed state, theplate400 is flat, while in a stressed state, it is curved.
• Afterplate400 is secured tovertebra300, ascrew202 or other fastener configured to perform a like function, is connected betweenplate400 andspacer5000.Screw202 is rotatably connected to plate400 whereby asscrew202 is rotated,spacer5000 is drawn closer toplate400. Herein, screws should be considered as levers; accordingly, screw200 functions as a lever to facilitate movement of one vertebra with respect to another.Vertebra302, being connected tospacer5000, is likewise drawn closer to plate400 asscrew202 is rotated, the assembly thereof ultimately causing the therapeutically correct disposition ofvertebrae300,302 shown inFIG. 4. As is the case with this and other embodiments of the disclosure, after correction, the assembly may be permanently left in the body, or may be removed after a therapeutic period of time.
• Referring now toFIGS. 5A,5B, and6,vertebrae300 and302, as well as associatedligaments308, are relatively displaced. In this embodiment, an expandingspacer5002 is positioned betweenvertebrae300,302, for example after removal of all or part of intervertebral tissue, ordisc306A. In this illustration, an additional vertebral level is shown, includingvertebra300A. It should be understood in all embodiments herein that more than one level may be corrected using methods and devices of the disclosure. For example, multiple plates may be used, or longer plates spanning more than one level.
• InFIGS. 5A,5B, and6,spacer5002 may be of any known or hereinafter invented type, including spacers having, for example, mechanical or hydraulic mechanisms of expansion.Vertebra302 is connected to plate400 withbone screw200. In one embodiment,spacer5002 is connected to plate400, to ensure that spacer5002 remains in position with respect tovertebra302, although this is not needed in all cases. For example, spacer5002 may be separately engaged withvertebra302.Tool6000 includes abrace6002 and adriver6004 moveably connected to brace6000.Brace6000 is releasably engageable withplate400 atconnector6006.
• To correct an alignment of the spine,driver6004 is moved with respect to brace6002, for example through a threaded, hydraulic, motor, or other moveable attachment betweendriver6004 andbrace6002. It should be understood that herein, drawings are not necessarily to scale, and that portions of spacers, plates, their assemblies, or insertion and reduction tools may be sized to be inserted in their entirety, or as portions to be assembled, through a minimally invasive incision or through one or more percutaneous punctures, for example using an endoscope or cannula. Asbrace6002 is connected withplate400, a movement in the direction of arrow “A” inFIG. 5A causes a displacement in the direction “A” ofvertebra300 and associatedligaments308. Prior to, during, or after movement ofvertebra300,spacer5002 may be expanded to disposevertebrae300,302 at a correct relative distance, and to provide further stability to the spine. InFIG. 6,tool6000 is detached, and if needed, anadditional bone screw200 may connectplate400 andvertebra300. One ormore screws200 may alternatively pass throughplate400,spacer5002, and orvertebra300. In an alternative embodiment,plate400 is not used, andbrace6002 is releasably connectable to expandingspacer5002.
• With reference toFIGS. 7-9, an assembly of the disclosure includes atool6010 cooperative withplate400, attached tovertebra300 byscrews200.Tool6010 includes achassis6012 extendable around a vertebra, and moveably attached toplate400. In some embodiments, thechassis6012 can be formed of multiple pieces, or of a single piece. More particularly,plate400 attaches to afirst vertebra300, extends proximate asecond vertebra302 which it is desired to reduce into alignment with thefirst vertebra300.Chassis6012 includes one or more extensions attached toplate400, extending to engagevertebra302 about a side ofvertebra302 opposite to a location ofplate400, to thereby at least partially encirclevertebra302 to effect a positive engagement. It should be understood, however, thatchassis6012 may frictionally engagevertebra302 along a side surface ofvertebra302, or may be connected tovertebra302 with one or more fasteners.
• In the embodiment shown, screw202 threadably engageschassis6012 androtatably contacts plate400, whereby asscrew202 is turned,chassis6012 is pushed away fromplate400, thereby drawingvertebra302 into alignment withvertebra300. When a desired alignment is accomplished,vertebra302 may be attached to plate400 to maintain the alignment, orvertebra302 may be fastened tospacer5000, or tovertebra300, by any other known or hereinafter invented means, if needed. Oncevertebra302 is sufficiently stable in its new disposition,tool6010 may be removed.
• InFIGS. 10 and 11, an assembly of the disclosure includes a spacer5010 which is formed of twomating portions5012,5014, and forms, in the illustrated embodiment, an angular external profile corresponding to a desired disposition ofadjacent vertebrae300,302. It should be understood that the illustrated concept applies equally to non-angular or other external profiles.Mating portions5012,5014 are provided with serrations, teeth, or other interlockingengagements5016,5018, whereby whenmating portions5012,5014 are overlapped completely or to a desired extent, a relative position ofmating portions5012,5014 is fostered, particularly whenmating portions5012,5014 are pressed together, for example betweenvertebrae300,302, by natural compression and associated ligaments308 (not shown).Mating portions5012,5014 may also be secured together by a fastener, including a screw or adhesive.
• InFIGS. 10-11, interlockingengagements5016,5018 have the form of ramped teeth, whereby a mutual sliding engagement, advantageously in a direction of therapeutic alignment ofvertebrae300,302, is facilitated, but discouraged in a direction away from therapeutic alignment, as may be seen inFIGS. 10-11. Atool6018, diagrammatically illustrated inFIG. 10, urges, translates, or pushes thevertebra300 in a desired direction indicated by arrow “A”.Tool6018 may be a mechanical device, for example as described within this disclosure, or may be a medical practitioner's hand.
• In an embodiment illustrated inFIGS. 12-13,mating portions5012,5014 may or may not have interlocking engagements, as shown, but are secured in mutual engagement by a fastener, such asscrew202, which is advantageously the same screw as used to manipulatemating segment5014 inFIG. 10.Screw202 may advantageously be passed through afirst vertebra300 and threadably fastened into asecond vertebra302.
• Tool6018, diagrammatically illustrated inFIG. 14, may be configured and or used to engage bothspacer5000 andvertebra300, advancing both together until a therapeutic alignment is attained. After reduction,vertebrae300,302 andspacer5000 may be secured as described elsewhere within the disclosure.
• InFIG. 15,vertebra300 is reduced in sliding engagement withspacer5000. After reduction, natural or induced compression, for example by compression due to body weight, or engagement with bone screws, promotes insertion of textured surface orprojections5020 with bone or body tissue, securing a position ofspacer5000 and relative alignment ofvertebrae300,302.
• InFIG. 16, an assembly of the disclosure includes instrument ortool6020, used to reducevertebra300 in cooperation withspacer5030. Abrace6022 abuts or connects withspacer5030, which may be adapted to securely engagebrace6022 during reduction. In the example ofFIGS. 16-18, a threadedconnection6024 is used, although other types of releasable mechanical abutments or interlocks may be used. Oncebrace6022 is connected withspacer5030, it may serve to align and guide apush rod6026, slideably connected to brace6022 by aguide6028, in this embodiment a guide ring attached to brace6022 through whichpush rod6026 slideably passes. Anengagement surface6030 is sized and shaped to move within the body, securely contact body tissue, and urge bones into alignment whenpush rod6026 is pushed towards body tissue. Oncevertebrae300,302 are aligned,tool6020 may be disconnected fromspacer5030 and removed from the body. In one embodiment,tool6020 is sized and dimensioned to be used through a minimally invasive percutaneous opening in the skin, or using endoscopic techniques.
• As with the embodiment ofFIGS. 16-18, the assembly ofFIG. 19 engages a tool to a spacer, to anchor and orient a tool for displacing and realigning a bone. In the embodiment ofFIG. 19,tool6032 is releasably connected tospacer5000, in this embodiment withscrew202, and includes alever6034 which transmits a displacement force to anadjacent vertebra302. A threadedadjuster6036 includes ascrew6038 rotatably mounted to aguide6040,screw6038 operative to advance anengagement surface6042 to contact and movevertebra300. As resistance is imparted totool6032, force is transferred to screw202, and a rotational moment oftool6032 is transferred tolever6034. In this manner, thevertebrae300,302 to be relatively aligned share a load force, and are each displaced to an extent, in opposite directions. This is further advantageous at least for the reasons that the tool is stabilized, and a displacement force imparted bytool6032 is shared betweenspacer5000 andvertebra302. In some embodiments, a biasing member, such as for example anoptional spring6044, may advantageously be included to biasengagement surface6042 in a direction ofvertebra300. Additionally or alternatively, thespring6044 may limit an extent of force imparted tovertebra300 byscrew202 andengagement surface6042, by enablingscrew6038 to move in an opposite direction to an applied force againstvertebra300. In other embodiments, thescrew6038 acts on its own without the assistance of a biasing member, such asspring6044.
• With reference toFIG. 20, an assembly of the disclosure includes aplate410 which has one ormore guide extensions412 operative to maintain a relative alignment ofplate410 andvertebra302 asvertebra300 is reduced. More particularly, one ormore screws412 may be used to drawvertebra302 towards a conforming engagement withplate412. Concomitantly, an upper portion414 ofplate410contacts vertebra300, which is displayed in a manner such as is illustrated inFIG. 19. When screws412 are fully seated,plate410 is in conforming engagement withvertebra300 and302, upper portion414 having urgedvertebra300 into alignment withvertebra302, as shown.Guide extensions412, extending for example on opposing sides ofvertebra302, may be secured tovertebra302 to maintain a lateral alignment ofplate410 with respect tovertebra302. Upper portion414 may be secured tovertebra300, or as shown, may moveablycontact vertebra300, allowing an extent of natural movement betweenvertebrae300,302.
• InFIG. 21, an assembly of the disclosure includestool6050 having alever6052 pivotally connected to plate418 athinge6054. Plate,418 is connected tovertebra302 by a fastener, such as one ormore screws200. Alever screw6056 is moveably connected to lever6052, and is connected tovertebra300. Aslever6052 is pivoted, for example by application of a manual or mechanical force,vertebra300 is moved correspondingly. When a desired alignment ofvertebra300 is attained,tool6050 andplate418 may be removed. Alternatively,hinge6054 may be disassembled, andplate418 may remain in the body. In such an embodiment,plate418 may be configured to fusevertebrae300,302, for example by being taller than illustrated, whereinscrew200 may be passed throughplate418 intovertebra300. In another alternative,screw6056 may be seated to securelever6052 againstvertebra300. An extendingportion6058 oflever6052, if present, may be removed, for example by disassembly, or by being separated from a remainder oflever6052 at a weakenedportion6060. In this configuration, articulation is preserved or provided betweenvertebrae300 and302, athinge6054.
• With reference toFIGS. 22-23, an assembly of the disclosure includes alever6064 which engageslever points5046,5048, shown as projecting pins onseparate portions5042,5044 ofspacer5040.Lever6064 is advantageously sized and shaped tolever vertebrae300,302 into a correct relative alignment by applying an opposing force to leverpoints5046,5048. After a therapeutic alignment has been carried out,portions5042,5044 ofspacer5040 may be affixed relative to each other by a fastener, forexample screw202, as shown inFIG. 23.Projections5046,5048 may be removed after use. Alternatively, it should be understood that lever points5046,5048 may be recesses or cutouts formed inportions5042,5044, thereby reducing an overall profile ofspacer5040.
• FIGS. 24 and 25 are analogous toFIGS. 22-23, howeverlever6070 engages one ofseparate portions5042A,5044A, of spacer5040A, and body tissue associated with an opposed vertebra.Lever6070 thereby directly pushes body tissue ofvertebra300, obtaining leverage provided bylever point5048, attached to anadjacent vertebra302.FIGS. 22-23 and24-25 illustrate differing forms of spacer,5040 and5040A, in order to demonstrate additional advantageous embodiments of spacer. It should be understood that spacers illustrated throughout the specification may be substituted with each other, as would be understood by one skilled in the art.
• InFIGS. 26-27, an assembly of the disclosure includesplate420 which is fastened tovertebra300, and ascrew200 is rotatably connected to plate420 and threadably engaged withvertebra302, whereby progressive rotation ofscrew200 drawsvertebrae300,302 into mutual conforming contact withplate420. As with all embodiments herein, screw200 may be any form of bone screw best adapted to the body tissue of the patient and the forces of the application, including for example a Gruberger or lag screw. One ormore washers220, for example polymeric or metallic washers, may additionally be used to avoid damage to an implanted component, or to avoid the production of debris. After the bones are reduced,plate420 may be removed, as illustrated inFIG. 27, or may remain in the body for a period of time, for example untilvertebra300,302 are stable in relative relation, or have fused if fusion is desired. InFIG. 27, fasteners such asscrews200 are illustrated, maintainingvertebrae300,302 in relative position through engagement withspacer5000. In the various embodiments,spacer5000 is illustrated for simplicity and clarity. It should be understood, however, that a position ofvertebrae300,302 may be maintained by any other known or hereinafter developed method, including for example rods, dynamic fixation, articulating plates, or cables. In embodiments,lever6064 orlever6070 has the form of an elongated bar.
• FIGS. 28-29 illustrate aspacer5050 having non-parallelbone engaging surfaces5052,5054 forming a wedge shape. Any of the methods and apparatus of the disclosure may be used to alignvertebrae300,302, together with a wedge shaped spacer, such asspacer5050.FIGS. 28-29 further illustrate that a therapeutic alignment is any alignment which is beneficial for the patient, whether natural and expected, or unique to an individual patient.
• FIG. 30 illustrates reduction ofbones300,302, with an assembly of the disclosure which includes a wedge shaped spacer5050, and which uses the apparatus and method described above with respect toFIGS. 28-29, although other methods and apparatus as described herein may be used as would be understood by a medical practitioner.
• FIGS. 31-32 illustrate an apparatus and method similar to that ofFIGS. 26-27 as employed at the L5-S1 level. While thesacrum310, in particular, is illustrated here, it should be understood thatvertebra300,302,310 may be any vertebrae or jointed surface of the body.
• FIGS. 33-34 also illustrate an apparatus and method similar to that ofFIG. 26, however in this embodiment,screw204 is provided withthreads206 which engage anut208 at one end, and body tissue at an opposite end.Screw204 is passed through, or otherwise engagesplate420, for example with a notch (not shown), and is fastened to body tissue. Two nuts secured together may be employed at the end ofscrew204 for engaging a driving tool, or alternatively, screw204 may be provided with a tool engaging surface, for example a hex, slotted, or Phillips engagement (not shown). If such engagement interferes with passage ofnut208 ontoscrew204,nut208 may be passed first along the bone engaging end ofscrew204. Afterscrew204 is engaged with body tissue, in thisexample sacrum310, andplate420,nut208 may be driven uponscrew204 and in engagement withplate420, to moveplate420 andsacrum310 together, either by displacingsacrum310,vertebra300, or a combination of both, until alignment is achieved, as shown inFIG. 34. After alignment,screw204 may be reduced in length to avoid interference with body tissue, particularly after an opening in the body is closed. Whilescrew204 may be severable with a tool, for example a saw or cutting shears, one or moreweakened regions210 may be provided along the length ofscrew204 to facilitate breaking off or otherwise removing an excess length ofscrew204.
• FIGS. 35-36 illustrate reduction ofvertebrae300,302 using anelongate screw212 which passes through the intervertebral space, connecting two adjacent bones.Threads214 are formed on a distal end ofscrew212, whereby after passing through and seating withinvertebra300, screw212 may thereafter freely rotate in connection withvertebra300. Screw head216 is sized to block movement of screw through the cortical bone ofvertebra300. Oncescrew212 is seated withinvertebra300,threads214 continue to engage tissue ofvertebra302, thereby drawingvertebra302 towardsvertebra300, and into a therapeutic alignment. After alignment,screw212 may be left within the body, or removed, optionally replaced by alternative means for maintaining an alignment ofvertebrae300,302.
• With reference toFIGS. 37-38,assembly128 includes aratchet tool6080 having alever6082 attached to a toothed rack, pawl, orgear6084, engaged with one or more mating racks6086. Adrawbar6088 is releasably engaged withvertebra300, for example withangled teeth6090. More particularly,teeth6090 may be slidingly positionable with respect tovertebra300 in a first direction, and engageable with tissue associated withvertebra300 in a second direction, wherebyvertebra300 may be reduced in the second direction whendrawbar6088 is engaged and displaced.Drawbar6088 is connected to rack6086, whereby movement ofrack6086 causes a corresponding movement ofdrawbar6088, whereby a medical practitioner may move an engaged vertebra in a second direction. In one embodiment,gear6084 is rotatable about a fixedpoint6092 with respect tovertebra300, whereby movement oflever6082 causes reduction ofvertebra300 with respect to fixedpoint6092.
• In another embodiment, asecond drawbar6088A engages asecond vertebra302, however in this embodiment angledteeth6090A slidingly engagevertebra302 in the second direction, and engage tissue associated withvertebra302 in the first direction.Rack6086A additionally engagesgear6084, whereby movement oflever6082, causes movement ofdrawbars6088,6088A in opposite directions, thereby applying a moving force to bothvertebrae300,302, but in opposing directions, promoting relative alignment ofvertebrae300,302.
• InFIGS. 39-40, an assembly of the disclosure includes aspacer5058 having twomating portions5060,5062, each releasably or fixedly engageable with a vertebra at abone engaging surface5064,5066. Mating surfaces5070,5072 are connected to move relative to each other, joined by a slidingfastener5074. Anadjusting device5076 is associated with slidingfastener5074 to retain a relative position ofmating portions5060,5062, together with engagedvertebra300,302, once sliding alignment is carried out. In the embodiment illustrated, adjustingdevice5076 includes a threadedrod5078 engageable within achannel5080,5082 disposed in each ofmating surfaces5070,5072, however it should be understood that other mechanical couplings are contemplated within the disclosure, as would be understood by one skilled in the art, for example including a riveted or molded coupling. Advantageously, threadedrod5078 may be threadingly received withinmating surfaces5070,5072, whereby a distance betweenvertebrae300,302, for example distraction, may also be carried out, in addition to reduction. Additional threaded nuts, or other fastener, not shown, may be used along threadedrod5078 to secureadjusting device5076 at a desired location alongchannel5080,5082.
• Referring now toFIGS. 41-44, a wedge shaped spacer5090 includes recessed or projectingengaging surfaces5092.Spacer segments5096,5098 are sized and dimensioned to be connectible with facing portions ofvertebrae300,302, and are provided with projecting or recessedengaging surfaces5100 complementary to and mateable with engagingsurfaces5092. Asspacer5090 is inserted betweenvertebra300,302, a distraction ofvertebra300,302 takes place due to the wedge shape, and the force with which spacer5090 is inserted. When spacer5090 is sufficiently inserted, engagingsurfaces5092 and5100 will engage, initially in connection with one ofsegments5096,5098. Subsequently, the medical practitioner displaces or reduces one or both ofvertebrae300,302 until they are therapeutically aligned. Manipulation ofvertebrae300,302 may be carried out by engagingsegments5096,5098 manually, or with a tool, forexample using screws218, or other engageable surface. Alternatively, or additionally,vertebrae300,302 may be directly manipulated.
• Engagingsurfaces5092 and5100 are positioned so that a complementary engagement takes place when a therapeutic alignment ofsegments5096,5098, andspacer5090 has been accomplished. Accordingly, after alignment, an engagement is made between engagingsurfaces5100 ofsegment5098 and engagingsurfaces5092 ofspacer5090, and engagingsurfaces5100 ofsegment5096 andspacer5090, thereby aligning all ofvertebra300,segment5096,spacer5090,segment5098, andvertebra302.
• After alignment, body tissue associated withvertebrae300,302, such asligaments308, maintain engagement ofsegments5096,5098, andspacer5090. Additionally,spacer5090 may be further secured to either or both ofsegments5096,5098 by fasteners, including adhesives or threaded fasteners. Similarly,segments5096,5098 may be secured to body tissue.
• FIGS. 43-44 illustrate alternative configurations of the embodiment ofFIGS. 41-42, in whichsegment5096A or5098A have a sloped shape, adapted to complement a wedge shape ofspacer5090. In this embodiment, a relative angular alignment ofvertebrae300,302 is not changed, however an anterior-posterior displacement may be corrected. Alternatively, an increased angular alignment may be achieved by the use of an alternative angular profile ofsegment5096B and orsegment5098B, as shown inFIG. 44.
• With reference toFIGS. 45-46, any tool of the disclosure may be used to address a displacement ofvertebrae300,302, to form an assembly including adynamic spacer5110 which is used to distract a joint formed betweenvertebrae300,302. In this embodiment,exemplary tool6010, as described with respect toFIGS. 8-10, is used to reducevertebrae300,302. During or after the reduction of a displacement ofvertebrae300,302, distraction is achieved usingspacer5110, which may be resilient, or which may be expanded by the introduction of a gas or fluid, for example purified air or sterile saline. After distraction, any known form of stabilization may be employed, for example including a plate, rod, or cable.Spacer5110, as with any spacer of the disclosure, may be provided with a surface texture and or a releasable therapeutic substance which, for example, promotes bone growth.
• InFIGS. 47-48, an assembly of the disclosure is illustrated which is similar to the assembly and method described with respect toFIGS. 33-34, but is configured to cooperate withspacer5120. More particularly, spacer5120, which may have the form of any spacer of the disclosure, is secured to plate420 by any known means, includingscrew202, as illustrated. This further stabilizesvertebrae300,302, and maintains a therapeutic location of a spacer. In a further embodiment, a connection betweenspacer5120 andplate420 is partly or substantially rigid, preserving at least a portion of a natural range of motion.
• The assembly ofFIGS. 49-50 is analogous toplate420 and screw204, and functions in a like manner. However,plate420 is connected to, or formed together with,spacer5124. In this manner, a superior-inferior disposition ofvertebrae300,302 may be achieved during insertion ofspacer5124, followed by a reduction in an anterior-posterior direction during tightening ofnut208. This embodiment further provides for fixation of adjacent vertebrae. Either or both ofextensions5126,5128 may be flexible, to preserve at least a portion of a natural range of motion.
• InFIGS. 51-52, aspacer5130 includes twosegments5132,5134, each connectable to avertebra300 or302. Eachsegment5132,5134 has a rampedsurface5136,5138 complementary to the other, whereby assegments5132,5134 are moved relative to each other into an overlapped conformity, a height ofspacer5130 is increased. In this manner,segments5132,5134 may be assembled into an intervertebral space, engaged with body tissue of adjacent vertebrae, and then slide along rampedsurfaces5136,5138 into overlapping conformity, whereby reduction and distraction can both be accomplished simultaneously. A sufficient engagement may be achieved betweensegments5132,5134 and therespective vertebrae300,302 to which they are attached, by projections5140, or adhesive. An engagement may be further secured by the use of one or more bone screws200.
• In the embodiment ofFIGS. 51-52, reduction may be carried out by apparatus and methods of the disclosure. In one embodiment, a fastener, forexample screw202 inFIG. 51, may be used to attach to a tool. InFIG. 52,vertebrae300,302 are aligned, andsegments5132,5134 are secured to each other, for example using adhesive or other fastener, such asscrew202, illustrated. In another embodiment, screw202 may freely rotate within a slot (not shown) insegment5134, and be threadably received withinsegment5132, whereby reduction and distraction may be carried out, at least in part, by rotatingscrew202.
• Referring toFIGS. 53-54, an embodiment includes aspacer5150 havingsegments5152,5154, each connectable to avertebra300 or302. A threadedshaft5156 is disposed betweensegments5152 and5154, threadably engaging threadedsurface5158 ofsegment5152, and slidingly engagingsurface5160 ofsegment5154. Asshaft5156 is rotated,shaft5156 engages threadedsurface5158, drivingsegment5152 into alignment withsegment5154, thereby aligning the attachedvertebrae300,302. One ormore shaft collars5162 prevents movement ofshaft5156 out of engagement withsegment5154. An alignment ofsegments5152 and5154 may be maintained with a fastener, forexample screw202, thereby maintaining an alignment ofvertebrae300,302.
• In some embodiments, the threadedshaft5162 can be configured to allow for a movable upper member (e.g., such as a movable segment5152) to move relative to a stationary lower member (e.g., such as a stationary segment5154). The movable upper member can be attached to a superior vertebral body, while the stationary lower member can be attached to an inferior vertebral body.
• InFIGS. 55-56, aplate430 may be therapeutically used alone, or in combination with other devices of the disclosure, to provide stability to adjacent bones, forexample vertebrae300,302.Plate430 includes anexterior plate432, and aplate extension434 sized and dimensioned to project into an articulating region of the joint when the exterior plate is fastened to adjacent bones.Plate extension434 further includes one ormore projections436 configured to pierce body tissue of adjacent bones within the articulating space, thereby securing a location of the adjacent bones,plate extension434, andexterior plate432, relative to each other. In this manner, after adjacent bones, forexample bones300,302 are aligned in accordance with the disclosure,plate430 may be inserted and secured within the intervertebral space to prevent, through engagement ofprojections436, to prevent a migration or movement ofvertebrae300,302 out of alignment. To furthersecure vertebrae300,302 andplate430 relative to each other, bone screws200 may be passed throughapertures438. A locking screw or pin442 (an example is shown inFIG. 78) may be attached atlock location440, to prevent reversal ofscrews200 after installation.
• InFIGS. 57-59,spacer5170 is connectable to plate444 by one or more fasteners, for example one or more screws202 (not shown). One or more bone screws200, or other fastening method of the disclosure, may be used to securespacer5170 in a joint space, for example in the intervertebral space betweenvertebrae300,302, prior to connectingplate444. In this manner, additional space is provided for accessing the joint space.Plate444 may thereafter be connected tospacer5170. As an alternative to connectingplate444 tospacer5170 directly, one or more bone screws200 may be passed throughapertures446 inplate444, throughapertures5176 inspacer5170, and into body tissue. After connection tospacer5170,plate444 may be connected to opposing sides of the joint, for example to cortical bone ofvertebrae300,302. In this manner, an alignment ofvertebrae300,302 may be preserved, asvertebrae300,302 are connected to each other at least through a mutual connection toplate444, and additionally viaspacer5170, either throughscrews200, and or viaprojections5172, or by bone ingrowth, for example through anaperture5174 inspacer5170. Finally, additional support is achieved by connecting spacer5170 andplate444, as described.
• InFIG. 60,spacer5170 is utilized, as described with respect toFIGS. 57-59, however plate448 is provided with one or more projections or posts450 which mateably engagespader5170. In this manner,spacer5170 may be inserted to a desired depth within the joint space, and post450 may be engaged withspacer5170 to prevent a change in angular disposition between plate448 andspacer5170. In the embodiment shown, plate448 is further connectable with one of the bones of the joint, forexample vertebra300, however plate448 could extend in an opposite direction to be more easily connectable with a bone on the opposite side of the joint, forexample vertebra302. One or morebone screw apertures446 and locklocations440 may be provided as described herein. A fastener, forexample screw202, may be used to further engageplate444 andspacer5170, and to prevent movement ofspacer5170 within the joint space. Tool engagement surfaces452,5178 upon plate448 andspacer5170, respectively, are configured to facilitate releasable attachment of a surgical tool to an implanted device of the disclosure, for ease of manipulation.
• In another embodiment of the disclosure, shown inFIG. 63,plate456 connects to spacer5180 by a fastener as disclosed herein, or by a dovetail or other shaped connection.Spacer5180 is not provided with apertures5176 (as shown for example inFIGS. 58 and 62), or if they are present, they are not required to be used. More particularly,plate456 provides for anchoring bothplate456 and spacer5180 to the joint, using angulatedapertures458, through which bone screws or other fastener may be passed to connect with bones of the joint, forexample vertebrae300,302. Reduction ofvertebrae300,302 may be accomplished as disclosed elsewhere herein, orplate456 may be fastened to first onevertebra300, and then as bone screws are subsequently rotated into bone ofvertebra302,plate456 andvertebrae302 are drawn together, positioningvertebrae300,302 into alignment.
• The embodiment ofFIG. 64 is similar to the embodiment ofFIG. 63; howeverplate460 includes one or more shaped projection464 that function to conform to the particular shape of a bone to which it is engaged, such as the sacrum, to form a better, more stable fit, and to produce a smaller implanted profile. Lockinglocations440 are advantageously provided to prevent reversal of a fastener inserted throughbone screw apertures446.
• InFIGS. 65-68,spacer5200 includes twomateable segments5202,5204 which fasten together using aratchet interface5206.Segment5202 forms anintervertebral spacer portion5208 advantageously includingprojections5210 which engage body tissue in the joint space to reduce a likelihood of movement of bones of the joint relative tosegment5202. One or moremounting extensions5212 extend fromintervertebral spacer portion5208 and are configured, for example with one ormore apertures5236, to engage a fastener to securesegment5202 to body tissue, for example by passage of abone screw200 through mountingextension5212 and into cortical bone of one ofvertebrae300,302.
• Segment5204 slideably engagessegment5202, formed to project into and nest within agroove5214 on an inner face5216 ofintervertebral spacer portion5208. Adjacent to, or incorporated withingroove5214 and mating portions ofsegment5204, are rampedengagement surfaces5218,5220 which admit passage past each other assegment5204 is slidingly engaged withsegment5202 to pass into aninterior passage5222 ofsegment5202, and which prevent a reversal of this engagement ofsegments5202,5204. Engagement surfaces5218,5220 form an interference fit with respect to each other, and are permitted to engaged successive mutually facing ramped surfaces by a resilient bending of the material ofsegments5202,5204. It should be understood thatgroove5214 may be formed withinsegment5204, andsegment5202 could be formed to extend thereinto.
• Segment5204 is similarly provided with aninterior passage5224, whereby the mated segments form an opening betweenvertebrae300,302, through which bone growth may therapeutically take place, for further stabilization, and to promote tissue health.Longitudinal projections5228 may advantageously be formed upon an upper and lower face of anintervertebral spacer portion5230, aligned along the direction of mateable sliding ofsegment5204 withsegment5202, and similarly serve to provide a stable engagement betweensegment5204 and body tissue into whichprojections5228 project.
• Segment5204 further has one ormore mounting extensions5226 extending from anintervertebral spacer portion5230. As with mountingextensions5212, mountingextensions5226 are configured to engage a fastener to securesegment5202 to body tissue, for example by passage of abone screw200 through mountingextension5212 and into cortical bone of one ofvertebrae300,302.
• To correct for a misalignment of bones of the joint,segment5202 is first securely connected to a bone of the joint, forexample vertebra300, using mountingextensions5212. Next,segment5204 is mounted tosegment5202 by slidingsegment5204 partially along a length ofgroove5214, until mountingextension5226 contacts tissue of the misaligned bone, forexample vertebra302. Next, using any of the methods described herein, including manually pushingvertebra302,segment5204 is driven further into mateable engagement withsegment5202, wherebyengagement surfaces5218,5220 cooperate to prevent reversal of the engagement, and maintainsegments5202,5204 at a desired extend of mutually overlapped engagement. Through engagement withsegments5202,5204, bones of the joint are maintained in relative alignment. Thus secured, no additional plates or stabilizing implants are required, although they may be used as deemed therapeutically beneficial for the patient.
• Segments5202,5204 may be moved relative to each other by attaching a lever betweensegments5202,5204, using a method or device as described herein.
• A fastener, including for example a screw or adhesive, may be used to further securesegments5202,5204 in mutual conformity, or to securesegments5202,5204 to body tissue. Bone growth materials, therapeutic drugs, or other beneficial substances may be placed withininterior passage5224.
• Spacer5240 ofFIGS. 69-73 is similar to the embodiment ofFIGS. 65-68, with certain distinctions, described herein. Elements having a similar function, therefore, will be similarly numbered, and reference may be had to the foregoing discussion for a description of their structure and function.
• Segments5242,5244 form a sliding connection therebetween formed by interlockingprojections5246 and recesses5248. A variety of interlocking forms may be produced by interlockingprojection5246 andrecess5248, including for example a mortise and tenon, dovetail, and half-dovetail type sliding joint. If a pair of interlockingprojections5246,5248 are provided, as illustrated, they may be configured to cooperate to form a secure sliding connection. For example, each projection may be provided with a single angular face, on relatively opposing sides of each of twoprojections5246.
• As may be seen inFIGS. 72-73, inspacer5240A,projection5246 andrecess5248, ofsegments5242A,5244A, are oriented to be slidable along an axis that is transverse with respect to an anterior-posterior axis of the body, whenextensions5212 are secured to an anterior face ofvertebrae300,302. In this manner, alignment of the vertebrae may be carried out along the coronal plane, as opposed to along the sagittal plane, as illustrated forspacers5200 and5240, when the respective spacer is implanted and affixed to the body.Projection5246 andrecess5248 may thus be aligned along any axis of the body, to address a particular pathology.
• Once a therapeutic alignment has been achieved,segments5242A,5244A are advantageously secured in relation to each other, to preserve an intended alignment of connected bones. As may be seen inFIG. 72, anoptional set screw5250 may be used to securesegments5242,5244, or any segmented device herein, or alternatively, other fasteners of the disclosure may be used, such fasteners including adhesive. Further, rampedengagement surfaces5218,5220, shown inFIGS. 65-68, may be provided. In addition, or in the alternative, other bone fixation devices may be used in combination withspacer5240,5240A, or any other device of the disclosure.
• It should be understood that eithersegment5242 or5244 may be formed with aprojection5246 orrecess5248, with the mating segment assuming the alternate profile.
• Referring now toFIGS. 74-78, aspacer5260 includes a coupling formed by agroove5262 into which acomplementary projection468 ofplate466 is inserted.Groove5262 andprojection468 may be shaped in any of a variety of mating configurations, including, as examples, a mortise and tenon, or a dovetail. It should be noted that foregoing coupling may be provided for other assemblies of a spacer and plate, in this disclosure; likewise,spacer5260 andplate466 may be connected using alternate methods of the disclosure.
• In an embodiment,spacer5260 andplate466 are inserted into a space between bones of a joint, for example in the intervertebral space, until aplate extension470 contacts bone of the joint, for example bone ofvertebra302. In the embodiment ofFIG. 74,plate extension470 has a projectingshape472 sized and dimensioned to contact a surface of thesacrum310, as shown inFIG. 79, although projectingshape472 may be adapted for contacting a different surface of the body, as shown for example inplate466A ofFIG. 75.
• InFIGS. 76-77, it may be seen that bone screws200, passed throughplate apertures474 ofplate466, may form angles along their longitudinal dimension that mutually converge. This is advantageous, for example, to ensure thatscrews200 obtain purchase in supportive tissue, that they do not extend vertebral body, and or that they do not interfere with body tissue that must be protected. InFIGS. 74-75 and78, it may be seen that screws200 may also form divergent angles.Plate apertures474 may be formed to guidescrews200 along intended angles, or may be polyaxial, whereby the medical practitioner may choose a therapeutically effective angular disposition ofscrew200, or other fastener.
• FIGS. 74-79 further illustrate that implanted devices of the disclosure may be formed withchamfered edges476, to facilitate implantation, and to reduce interference with body tissue. Additionally, where a screw or other fastener passes through a device of the disclosure, it is advantageous to ensure that the fastener does not back out from engagement with the device or body tissue, which could lead to injury or failure of the device.FIG. 78 illustrates a locking screw or pin442 operative to prevent substantially movement ofscrew200, or other elongated fastener, in a direction reverse to an installation direction, after implantation. A reducedprofile portion478 ofpin442 admits passage ofscrew200, whenpin442 is rotated so that reducedprofile478 facesaperture474, as shown in a lower left screw ofFIG. 78. After a head portion ofscrew200 has passed reducedprofile478,pin442 may be rotated so that a non-reduced portion ofpin442 blocks a path ofscrew200, as shown for the lower right screw.
• FIGS. 80-84 illustratetool6020A, a variation oftool6020 ofFIGS. 16-18, illustrated in use together with the embodiment ofFIG. 74. InFIG. 80, it may be seen thattool6020A includes handles, advantageously including abiasing element6102, and alock6104 to maintain handles in a desired disposition. Apivot6106 enables movement of handles to effect a corresponding movement ofgrippers6108, shaped and dimensioned to cooperate withtool engagement surfaces5178, which are advantageously formed uponspacer5260 and orplate466, for this purpose.
• The functions ofengagement surface6030,push rod6026, and guide6028 have been explained with respect toFIGS. 16-18. It may further be seen thatpush rod6026 is formed with agroove6110 engageable with a projection ofguide6028, operative to thereby prevent rotation ofpush rod6026 and connectedengagement surface6030. Additionally visible is an internally threadedcollar6112, cooperative with a threadedexternal portion6114 ofpush rod6026, threadedcollar6112 rotatably fixed withinsupport6116 to advance or withdrawpush rod6026 to effectuate movement of contacted body tissue. A proximal tool engaging end6118 of threadedcollar6112 may be engaged and driven by a tool, for example a powered drill or t-handle, to rotatecollar6112. As rotation and reduction take place along the same axis, control of the reduction is optimized.
• InFIGS. 16-18, a threadedconnection6024 is formed betweentool6020 andspacer5030. In the embodiment ofFIGS. 80-84,grippers6108 engage an external surface ofspacer5260. Alternatively, bothgrippers6108 and threadedconnection6024 may be formed.FIG. 81 illustrates an assembly ofspacer5260 andplate466 gripped bytool6020A. InFIG. 82,tool6020A has been used to push the assembly into a disc space formed betweenvertebra300 andsacrum310. Subsequently, screws200 have been inserted into the caudal vertebra, orsacrum310. InFIG. 83,engagement surface6030 has been advanced, through rotation of threadedcollar6112, to engage andurge vertebrae300 posteriorly with respect tosacrum310, into therapeutic alignment. InFIG. 84, one ormore screws200 are inserted into the cephalad bone,vertebra300, to thereby fix an alignment ofvertebra300 andsacrum310.
• FIGS. 85A-85C depict a method of inserting a spacer in accordance with the disclosure. InFIG. 85A,adjacent vertebrae300,302 are being distracted. In some embodiments, the vertebrae are overdistracted to provide space for a spacer, such as any of those shown in the above embodiments. InFIG. 85B, after overdistracting the vertebrae,vertebra302 can be aligned withvertebra300. Any of the devices, systems and methods discussed above can be used to align theupper vertebra302 with thelower vertebra300. InFIG. 85C, after alignment of the vertebrae, aspacer5000 with surface protrusions can be inserted into the disc space between the overdistracted vertebrae. Once the spacer is inserted into the disc space, thevertebrae300,302 can be compressed over the spacer, thereby completing the surgical procedure.
• FIG. 86 depicts a side view of acombinable spacer5040, plate having anupper lip5055 andfasteners202 of the disclosure. Advantageously, theupper lip5055 of the plate can contact theupper vertebra300, such that when the combined spacer and plate is forced anteriorly, theupper lip5055 can help to push theupper vertebra300 into alignment with the lower vertebra.
• FIG. 87 depicts a side view of an alternative plate and spacer combination, similar to that shown inFIG. 34. In this embodiment, one ormore screws200 can be provided through theplate420. Thescrews200 can be aligned such that at least one enters a vertebral body, while at least one other enters into adisc306.
• The devices and methods of the disclosure enable delivering and implant and reducing spondylolisthesis from an anterior approach, although other approaches are possible. More particularly, the disclosure provides for delivering an implant and reducing the spondylolisthesis using a single tool, thereby at least reducing separate approaches into the body, and reducing time required for the procedure, for the benefit of the patient and the medical practitioners, while reducing risks and costs. Additionally, by performing insertion and reduction using a single implant, and by using a single tool, accuracy is improved, and manipulation of body tissue is minimized.
• Spacers, plates, and fasteners of the disclosure may be formed with biocompatible materials, of sufficient purity, including for example PEEK (polyether ether ketone), titanium, stainless steel, or a cobalt chromium alloy. Other polymers, metals, alloys, or composite materials may alternatively be used, as known in the art, or hereinafter developed. A radiopacifier may be added to devices of the disclosure to improve visibility under imaging. Devices of the invention may be formed by extrusion, milling, forging, casting, molding, or any other method advantageously used for the materials selected and the structure intended.
• It should be understood that, in the various embodiments illustrated and described herein, an assembly may include any or all of a spacer, plate, tool, and or fasteners, and although all such elements may be shown in a particular illustration, for brevity and compactness, one or more such elements may be eliminated in a particular medical application, as would be understood by one skilled in the art. For example, an implant such as a spacer may not require separate fasteners. Alternatively, adisc306 may be healthy, and not in need of replacement, or a spacer may be used without a plate.
• All references cited herein are expressly incorporated by reference in their entirety. There are many different features to the present invention and it is contemplated that these features may be used together or separately. Unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. Thus, the invention should not be limited to any particular combination of features or to a particular application of the invention. Further, it should be understood that variations and modifications within the spirit and scope of the invention might occur to those skilled in the art to which the invention pertains. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention.

Claims (20)

What is claimed is:

1. A device for therapeutically aligning two misaligned bones on opposite sides of a joint, comprising:

a first rigid extension securable to a first of the misaligned bones using a single approach selected from the group consisting of left lateral approach, right lateral approach, anterior approach, and posterior approach;

a second rigid extension having a contacting surface positionable in contact with the second of the two misaligned bones from the approach selected for securing said first rigid extension, said second rigid extension moveable with respect to said first rigid extension when said first rigid extension is secured to the first of the misaligned bones and said second rigid extension is positioned in contact with the second of the two misaligned bones; and

a lever configured to lever the first rigid extension with respect to the second rigid extension to move said first rigid extension with respect to said second rigid extension, to thereby exert a pulling force on the first of the two misaligned bones, and a pushing force on the second of the two misaligned bones, aligning the first and second misaligned bones.

2. The device ofclaim 1, wherein the first and second misaligned bones are vertebrae.

3. The device ofclaim 2, further including an intervertebral spacer, said first rigid extension securable to said intervertebral spacer, said intervertebral spacer connected to the first of the misaligned bones.

4. The device ofclaim 3, wherein said intervertebral spacer is formed in two segments, each segment attachable to one of the first or second misaligned bones, said segments moveable with respect to each other when attached to a respective misaligned bone.

5. The device ofclaim 4, said segments moveable in ratcheting engagement with respect to each other.

6. The device ofclaim 1, wherein said lever applies leverage using a rotatable thread.

7. The device ofclaim 1, wherein said first rigid extension is securable to the misaligned bone using a threaded fastener.

8. The device ofclaim 1, wherein said first rigid extension is a plate.

9. The device ofclaim 8, wherein said plate forms a levered connection between the first and second misaligned bones.

10. The device ofclaim 1, wherein said first rigid extension extends around the first misaligned bone to contact a portion of the first misaligned bone which faces an approach different from the approach selected.

11. The device ofclaim 1, wherein one of the first or second misaligned bones is the sacrum.

12. The device ofclaim 1, wherein the lever is a screw having threads configured to engage bone on a first end, and threads configured to engage a nut on a second, opposite end, the nut rotated about said second end move said second rigid extension and to thereby lever the first and second misaligned bones into alignment.

13. The device ofclaim 1, further including an intervertebral spacer.

14. The device ofclaim 13, wherein said intervertebral spacer is expandable to increase a distance between the first and second misaligned bones.

15. A device for therapeutically aligning two vertebrae, comprising:

a first rigid extension securable to a first of the vertebrae using a single approach selected from the group consisting of left lateral approach, right lateral approach, anterior approach, and posterior approach;

a second rigid extension having a contacting surface positionable in contact with the second of the two vertebrae from the approach selected for securing said first rigid extension, said second rigid extension moveable with respect to said first rigid extension when said first rigid extension is secured to the first of the vertebrae and said second rigid extension is positioned in contact with the second of the two vertebrae;

a lever configured to lever the first rigid extension with respect to the second rigid extension to move said first rigid extension with respect to said second rigid extension, to thereby exert a pulling force on the first of the two vertebrae, and a pushing force on the second of the two vertebrae, aligning the first and second vertebrae; and

a fastener configured to maintain the first and second vertebrae in relative alignment.

16. The device ofclaim 15, further including an intervertebral spacer connectable to at least one of the first and second rigid extensions during alignment of the vertebrae, and connectable to both vertebrae to maintain the vertebrae in relative alignment.

17. The device ofclaim 15, the first rigid extension forming a first portion of an intervertebral spacer, the second rigid extension forming a second portion of an intervertebral spacer, the first and second portions mateably engageable and maintainable in relative mutual engagement using a ratchet.

18. A method for therapeutically aligning two misaligned bones on opposite sides of a joint, comprising:

securing a first rigid extension to a first of the misaligned bones using a single approach selected from the group consisting of left lateral approach, right lateral approach, anterior approach, and posterior approach;

contacting the second of the misaligned bones with a second rigid extension, the second rigid extension having a contacting surface positionable in contact with the second of the two misaligned bones from the approach selected for securing the first rigid extension, the second rigid extension moveable with respect to the first rigid extension when the first rigid extension is secured to the first of the misaligned bones and the second rigid extension is positioned in contact with the second of the two misaligned bones; and

levering the first rigid extension with respect to the second rigid extension using a lever configured to move the first rigid extension with respect to the second rigid extension, to thereby exert a pulling force on the first of the two misaligned bones, and a pushing force on the second of the two misaligned bones, aligning the first and second misaligned bones.

19. The method ofclaim 18, further including inserting an intervertebral spacer between the two misaligned bones.

20. The method ofclaim 19, further including:

connecting the intervertebral spacer to the first of the misaligned bones; and

applying the lever between the intervertebral spacer and the second of the misaligned bones.

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