US20150045793A1 - Static Compression Device - Google Patents
Static Compression Device Download PDFInfo
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- US20150045793A1 US20150045793A1 US14/525,095 US201414525095A US2015045793A1 US 20150045793 A1 US20150045793 A1 US 20150045793A1 US 201414525095 A US201414525095 A US 201414525095A US 2015045793 A1 US2015045793 A1 US 2015045793A1
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- plate
- protrusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7059—Cortical plates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8004—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with means for distracting or compressing the bone or bones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8004—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with means for distracting or compressing the bone or bones
- A61B17/8019—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with means for distracting or compressing the bone or bones where the means are a separate tool rather than being part of the plate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8023—Variable length plates adjustable in both directions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8052—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
- A61B17/8057—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded the interlocking form comprising a thread
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8033—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
- A61B17/8042—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers the additional component being a cover over the screw head
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B2017/564—Methods for bone or joint treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
Definitions
- FIG. 44 is a bottom view of the male plate of the static compression device of FIG. 36 .
- the male plate 12 has a central protrusion 28 with a top surface 30 and a longitudinal axis 32 .
- Central protrusion 28 is dimensioned to mate with and secure the male plate 12 with the interconnecting plate 15 or the female plate 14 as will be described in detail hereafter.
- the interconnecting plate 15 is used, the combined length of the central protrusion 28 on the male plate 12 and the central protrusion 28 ′ on the interconnecting plate 15 will be slightly longer than the distance the SC device 10 is intended to provide compression over.
- the outer surfaces 63 of the left and right guides 58 , 60 contact the inner surfaces 37 of the side protrusions 29 under the influence of the locking clamp 16 , as will be described hereafter, to securely locate the female plate 14 with respect to the interconnecting plate 15 and the interconnecting plate 15 with the male plate 12 .
- the female plate 14 also in a preferred embodiment, has two screw receiving holes 82 .
- These screw receiving holes 82 receive standard cancellous bone screws 43 that are threaded into the bone of the vertebrae.
- the screw receiving holes 82 also have a bowl-shaped basin 84 on the upper surface 78 to receive the heads of the bone screws 43 and a throughhole 86 through which the main body of the bone screws 43 pass to come into contact with the vertebral body.
- the throughholes 86 are configured in a manner that allows the cancellous bone screws 43 to be rigidly fixed to the plate once inserted in bone by the interaction of the screws 43 with the basins 84 .
- the method of fixing the screws 43 to the female plate 14 may utilize any number of mechanisms well understood in the art that allow the screws 43 and the female plate 14 to maintain a rigid relationship once the screws 43 are inserted in bone.
- the male plate 12 and female plate 14 each have a notch 142 , 144 , respectively, located on opposite ends of the SC device 10 and shaped to receive the pins 132 in a snug, conforming fashion so that compression applied to the feet 122 , 124 by squeezing the handles 118 , 120 together is transferred from the distal ends 126 , 128 to the male plate 12 and female plate 14 , respectively, through the interaction of the pins 132 with the notches 142 , 144 .
- the gauge 146 has an indicator 152 that is an annular spacer located along the horizontal component 149 of arm 148 .
- the indicator 152 has a central opening 154 sized to be approximately the same size and shape as the cross-sectional size and shape of the horizontal component 149 of arm 148 so that indicator 152 is attached to the horizontal component 149 by sliding the horizontal component 149 through the first central opening 154 .
- a frictional fit between the first central opening 154 and the horizontal component 149 holds the indicator 152 in position on the horizontal component 149 .
- the central protrusion 28 is inserted into the protrusion receiving channel 56 ( FIG. 15 ). Because protrusion receiving channel 56 is dimensioned to receive central protrusion 28 with the locking clamp 16 in place, central protrusion 28 is precisely located and retained within the protrusion receiving channel 56 . In this position with the locking clamp 16 in place on the top surface 30 of central protrusion 28 , the ridges 46 and valleys 48 on the parallel sides 96 of locking clamp 16 come into loose contact with the inner surface 61 of left guide 58 and right guide 60 of the female plate 14 . ( FIG.
- the screwdriver 160 is coupled to the head 106 of the locking screw 18 .
- the screwdriver 160 is rotated so that the threaded body 108 of locking screw 18 is threaded into the threaded hole 35 .
- the locking screw 18 is then screwed further onto the central protrusion 28 on the male plate 12 so that the head 106 contacts the top surface 92 of the locking clamp 16 .
- the compression device 90 is removed. As a result, the compression applied to the SC device 10 through the compression device 90 will be locked to the vertebral bone through the male plate 12 and female plate 14 (and interconnecting plate 15 if used) because these various components are locked in a fixed relationship to each other.
- FIGS. 36-54 An alternate embodiment of the SC device 10 in a preferred embodiment shown in FIGS. 36-54 also has a male plate 12 and a female plate 14 .
- the SC device 10 in this embodiment also has a locking plate 316 and a locking screw 318 that, in combination with standard cancellous bone screws (not shown) fix the SC device 10 to the patient's vertebrae.
- This SC device 10 has a top side 320 , a bottom side 322 and opposed medial sides 324 .
- Protrusion 328 has a slot 344 extending entirely through it approximately perpendicular to the top surface 330 .
- Protrusion 328 also has a series of alternating ridges 346 and valleys 348 , collectively protrusion ridges 350 , located on a portion of its top surface 330 . Ridges 350 are preferable angled slightly with respect to the longitudinal axis 332 for a purpose to be explained hereafter.
- the locking mechanism 388 includes locking plate 316 and locking screw 318 as well as the ridges 346 and valleys 348 on the top surface 330 of protrusion 328 of the male plate 12 and the threaded hole 376 and channel 380 of female plate 14 as described below.
- Locking mechanism 388 converts “active” compression applied by the surgeon using the compression device 90 described above interacting with the SC device 10 at the time of surgery to “static” compression after surgery.
- the locking mechanism 388 also provides rigid fixation to the SC device 10 to optimize bone healing and preventing further settling from occurring.
Abstract
A Static Compression Device (SC device) for active, measurable compression of a spinal fusion graft is disclosed. The SC device attaches to adjacent vertebral bodies or other pieces of bone and works with a compression tool to apply compressive force to adjacent vertebral bodies or pieces of bone to assist fusion. Once compressed, the SC device locks to maintain the compression applied at surgery, while preventing further compression after surgery. In one embodiment, the compression device applies a desired amount of force to allow the surgeon more control over the force applied to a cervical, thoracic or lumbar implant than previously available. The SC device may compresses multiple adjacent vertebrae across adjacent bone graft(s) to facilitate fusion of these vertebrae to treat pain from damaged disks between vertebrae that may on the spinal cord and nerve roots. SC device may also apply compression across fractures to facilitate union.
Description
- This application is a Continuation-in-Part of application Ser. No. 13/709,864 filed Dec. 10, 2012, which is a Continuation of application Ser. No. 12/522,147, filed Jul. 2, 2009, which is a US 371 National Stage Entry of PCT/US07/06830 filed Mar. 20, 2007, which claims the benefit of priority from Provisional Application Ser. No. 60/788,607 filed Apr. 3, 2006. Each of the aforementioned applications is incorporated herein by reference.
- 1. Field of the Invention
- The present invention is directed to devices and methods to compress two or more adjacent vertebrae across an adjacent bone graft to facilitate fusion of these vertebrae to treat pain produced by pressure from the disks between such vertebrae bulging and resulting in contact with and pressure on the spinal cord and adjacent nerve roots.
- 2. Description of Related Art
- For nearly half a century, anterior cervical discectomy and fusion has been performed for individuals complaining of intractable upper extremity pain due to cervical disc herniation or bone spurs at single or multiple levels. This procedure has undergone several significant modifications since its inception. The introduction of the Smith-Robinson technique of using tricortical iliac crest bone graft, the technique of denuding vertebral endplates of cartilage described by Zdeblick et al., and the present use of cervical plates have all represented significant technical advances which have increased fusion rates and improved patient outcomes. Currently it is possible to expect greater than 85% good or excellent outcomes for individuals with appropriate indications who undergo this surgical procedure.
- However, several problems remain. Although fusion rates for one level anterior cervical fusion with autograft (patient's own bone) may approach 95%, these rates decrease significantly for each additional level incorporated in the fusion. Additionally, using autograft bone typically involves the use of a second incision, which significantly increases patient morbidity. Allograft bone (bone from another human) is a viable option, but has considerably lower fusion rates than autograft and is generally not considered a good choice in multiple level fusion surgery.
- The use of anterior cervical plates has been credited with increasing fusion rates in multiple level fusions. It is thought that the immediate stability provided by the plate provides a more favorable environment for fusion to occur. The vast majority of plates on the market provide for static stabilization of the vertebral body-graft construct (no compression, no dynamization). More recently dynamic plates have been introduced. These plates provide for passive dynamic compression of the vertebral body-graft construct. This compression occurs post-operatively when the weight of the patient's head loads the construct, allowing for passive compression of the graft to occur. Wolff's law (the concept that bone heals best under compression) suggests that the use of dynamic compression plates should lead to increased fusion rates. However, this has not been found to be the case. Several studies have indicated that dynamic compression plates do not lead to higher fusion rates than static plates. In addition, the possibility of uncontrolled settling over time which may lead to kyphosis (reversal of the normal curvature of the neck) has caused these plates to fall out of favor with many surgeons.
- Wolff's law is a well-accepted orthopedic principle, championed and reported in the trauma literature by the Swiss AO Foundation, a non-profit surgeon-driven organization dedicated to progress in research, development, and education in the field of trauma and corrective surgery. Several studies have shown that long bones heal best under rigid compression. This has led to the development of special compression plates that are currently widely used in surgical techniques of open reduction and internal fixation of fractures.
- It is believed that there is no plate on the market that truly invokes Wolff's law in spinal fusion surgery by providing rigid static loading of the graft-vertebral body construct. Mechanisms for achieving compression on adjacent vertebrae are known. But, most of these devices either utilize compression across individual screws (risking cut out due to lessened surface area) or attempt to achieve compression prior to the plate being applied (making this a cumbersome technique).
- The Static Compression Device (SC device) of the present invention allows for active, measurable compression of a fusion graft by the surgeon at the time of surgery. The SC device is attachable to adjacent vertebral bodies or other pieces of bone and has a device that applies compressive force to the adjacent vertebral bodies or other pieces of bone to assist fusion according to Wolff's law. The SC device has a locking mechanism that maintains the compression applied at surgery, but prevents further compression (settling) from occurring after surgery. So, the SC device allows the surgeon the ability to compress a segment or other adjacent pieces of bone, measure the applied compression, and to lock the segment or pieces of bone in the compressed position. In one embodiment of the invention, the pressure is applied to the SC device through a compression device that applies a desired and measurable amount of force. In this embodiment, the combination of the SC device with a pressure applying and measuring device allows the surgeon more control over the force applied to a cervical, lumbar or thoracic implant or implant applied to other pieces of bone than has previously been available.
- The SC device of the present invention in one embodiment compresses two or more adjacent vertebrae across an adjacent bone graft to facilitate fusion of these vertebrae to treat pain produced by pressure from the disks between such vertebrae, adjacent bone spurs or both bulging and resulting in contact with and pressure on the spinal cord and adjacent nerve roots or any other disorder of the spine. The vertebrae may be in the cervical, thoracic or lumbar spine. In fact, in various embodiments, the SC device may be used to apply measurable compression across any type of bony interface (e.g. fractures) to facilitate union.
- The SC device has four unique characteristics which together provide for static compression of the vertebral body-graft interface: [0012] The use of fixed angle screws to secure the SC device to the vertebral bodies; [0013] The use of a compression device to apply and measure the pressure applied to the vertebral bodies by the SC device; [0014] The technique of using active, static compression to assist the fusion process; and [0015] The use of a locking mechanism that maintains compression during the fusion process to facilitate bone growth. This SC device differs from currently known static plates by providing controlled loading (compression) of the graft at the time of surgery. The SC device also differs from currently known dynamic plates in that the compression achieved is “static” (rigid) and prevents further “dynamic” settling from occurring after the procedure is completed. The resulting major advantage of the SC device over previously known devices is that the SC device may significantly increase fusion rates (especially in multiple level cervical fusion) and maintain the anatomy of the cervical spine (preventing excessive compression leading to kyphosis). In fact, it is believed that using the SC device to provide static loading at each level in multiple level fusions may allow the use of allograft bone to approach fusion rates now only attainable by using autograft techniques.
- The invention will be described hereafter in detail with particular reference to the drawings. Throughout this description, like elements, in whatever embodiment described, refer to common elements wherever referred to and referenced by the same reference number. The characteristics, attributes, functions, interrelations ascribed to a particular element in one location apply to that element when referred to by the same reference number in another location unless specifically stated otherwise.
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FIG. 1 is a perspective view of one embodiment of the static compression device of the present invention. -
FIG. 2 is a top view of the static compression device ofFIG. 1 . -
FIG. 3 is a bottom view of the static compression device ofFIG. 1 . -
FIG. 4 is a side view of the static compression device ofFIG. 1 . -
FIG. 5 is a bottom end view of the static compression device ofFIG. 1 . -
FIG. 6 is a perspective view of the male plate of the static compression device ofFIG. 1 . -
FIG. 7 is a side view of the male plate of the static compression device ofFIG. 1 . -
FIG. 8 is a top view of the male plate of the static compression device ofFIG. 1 . -
FIG. 9 is a bottom end view of the male plate of the static compression device ofFIG. 1 . -
FIG. 10 is a perspective view of the female plate of the static compression device ofFIG. 1 . -
FIG. 11 is an end view of the female plate of the static compression device ofFIG. 1 . -
FIG. 12 is a bottom view of the female plate of the static compression device ofFIG. 1 . -
FIG. 13 is a perspective view of the interconnecting plate of the static compression device ofFIG. 1 -
FIG. 14 is a top view of the interconnecting plate of the static compression device ofFIG. 1 . -
FIG. 15 is a perspective view of the static compression device ofFIG. 1 in an embodiment without the interconnecting plate. -
FIG. 16 is a perspective view of the static compression device ofFIG. 15 in an unlocked configuration. -
FIG. 17 is a perspective view of the static compression device ofFIG. 15 in a locked configuration. -
FIG. 18 is a perspective view of the locking clamp of the static compression device ofFIGS. 1 and 15 . -
FIG. 19 is a side view of the locking screw of the static compression device ofFIG. 1 . -
FIG. 20 is a perspective view of one embodiment of the compression tool of the present invention. -
FIG. 21 is a perspective view of the embodiment of the compression tool ofFIG. 20 from the opposite side of the view ofFIG. 20 . -
FIG. 22 is a perspective view of the preferred embodiment of the compression tool of the present invention with cannula for receiving a screwdriver. -
FIG. 23 is a close up perspective view of the distal end of the compression tools of the present invention. -
FIG. 24 is a perspective view of another embodiment of the compression tool of the present invention. -
FIG. 25 is a side view of the embodiment of the compression tool ofFIG. 24 . -
FIG. 26 is an exploded perspective view of the turnbuckle of the embodiment of the compression tool ofFIG. 24 . -
FIG. 27 is an exploded perspective view of the compression tool ofFIG. 24 . -
FIG. 28 is a perspective view of an embodiment of the static compression device of the present invention. -
FIG. 29 is a perspective view of the static compression device ofFIG. 28 without the locking screw in place. -
FIG. 30 is a side view of the locking screw of the static compression device ofFIG. 28 . -
FIG. 31 is a cross-sectional perspective view of the static compression device ofFIG. 28 without the locking screw in place. -
FIG. 32 is a perspective view of the static compression device ofFIG. 28 without an alternate embodiment of the locking screw in place. -
FIG. 33 is a perspective view of an alternate embodiment of the static compression device. -
FIG. 34 is an end view of the female plate of the static compression device ofFIG. 33 with the locking screw and cam in place. -
FIG. 35 is a perspective view of the locking screw and cam of the static compression device ofFIG. 33 . -
FIG. 36 is a perspective view of one embodiment of the static compression device of the present invention. -
FIG. 37 is a top view of the static compression device ofFIG. 36 . -
FIG. 38 is a bottom view of the static compression device ofFIG. 36 . -
FIG. 39 is a side view of the static compression device ofFIG. 36 . -
FIG. 40 is a bottom end view of the static compression device ofFIG. 36 . -
FIG. 41 is a top end view of the static compression device ofFIG. 36 . -
FIG. 42 is a perspective view of the male plate of the static compression device ofFIG. 36 . -
FIG. 43 is a side view of the male plate of the static compression device ofFIG. 36 . -
FIG. 44 is a bottom view of the male plate of the static compression device ofFIG. 36 . -
FIG. 45 is a perspective view of the female plate of the static compression device ofFIG. 36 . -
FIG. 46 is an end view of the female plate of the static compression device ofFIG. 36 . -
FIG. 47 is a bottom view of the female plate of the static compression device ofFIG. 36 . -
FIG. 48 is a perspective view of the male plate and female plate of the static compression device ofFIG. 36 in an interconnected relationship. -
FIG. 49 is a perspective view of the male plate and female plate of the static compression device ofFIG. 36 in an interconnected relationship and with the locking plate in place. -
FIG. 50 is a perspective view of the male plate and female plate of the static compression device ofFIG. 36 in an interconnected relationship and with the locking plate and locking screw in place. -
FIG. 51 is a top view of the static compression device ofFIG. 36 with the male plate interconnected to the female plate and with the locking plate in place and in the uncompressed position. -
FIG. 52 is a top view of the static compression device ofFIG. 36 with the male plate interconnected to the female plate and with the locking plate in place and in the compressed position. -
FIG. 53 is a bottom view of the locking plate of the static compression device ofFIG. 36 . -
FIG. 54 is a side view of the locking screw of the static compression device ofFIG. 36 . -
FIG. 55 is a perspective view of an alternate embodiment of the static compression device. -
FIG. 56 is a perspective view of the static compression device ofFIG. 55 with the guide plate shown in phantom. -
FIG. 57 is a perspective view of a series of trial spacers and corresponding handle of one aspect of the present invention. -
FIG. 58 is a perspective view of an embodiment of the static compression device designed to be used in the thoracic or lumbar region of the spine. -
FIG. 59 is a perspective view of an embodiment of the static compression device designed to be used to treat fractures. -
FIG. 60 is a perspective view of an embodiment of the static compression device designed to be used to treat fractures. -
FIG. 61 is a top perspective view of an alternative embodiment of the static compression device for treating spinal fractures. -
FIG. 62 is a bottom perspective view of the embodiment ofFIG. 61 of the static compression device for treating spinal fractures. -
FIG. 63 is a top perspective view of the end plate of the embodiment ofFIG. 61 of the static compression device for treating spinal fractures. -
FIG. 64 is a bottom perspective view of the end plate of the embodiment ofFIG. 61 of the static compression device for treating spinal fractures. -
FIG. 65 is a top perspective view of the center plate of the embodiment ofFIG. 61 of the static compression device for treating spinal fractures. -
FIG. 66 is a bottom perspective view of the center plate of the embodiment ofFIG. 61 of the static compression device for treating spinal fractures. -
FIG. 67 is a top perspective view of the lock screw of the embodiment ofFIG. 61 of the static compression device for treating spinal fractures. -
FIG. 68 is a top perspective view of an alternative embodiment derived from the embodiment ofFIG. 61 having additional levels for treating spinal fractures of multiple vertebrae. -
FIG. 69 is a top perspective view of another alternative embodiment derived from the embodiment of 61 also having additional levels for treating spinal fractures of multiple vertebrae. - The
SC device 10 in a preferred embodiment shown inFIGS. 1-14 and 18 has five main parts, amale plate 12, afemale plate 14, an interconnectingplate 15, a lockingclamp 16 and a lockingscrew 18 that, in combination with standard cancellous bone screws (not shown) fix theSC device 10 to the patient's vertebrae. TheSC device 10 has atop side 20, a bottom side 22 and opposed medial sides 24. - The
male plate 12 has a malemain body 26 and acentral protrusion 28 extending away from the malemain body 26. Thecentral protrusion 28 has atop surface 30, alongitudinal axis 32, a bottom surface 33 andparallel sides 36.Central protrusion 28 also has a threadedhole 35 in thetop surface 30. - The
male plate 12 also has a pair ofside protrusions 29 extending away from the malemain body 26 on opposite sides of thecentral protrusion 28. Each of the side protrusions 29 has aninner surface 37 and anouter surface 39. Theinner surfaces 37 are directed toward thecentral protrusion 28 and are preferably curved in a concave fashion to mate with theouter surfaces 63 of theleft guide 58 andright guide 60 of the interconnectingplate 15 or thefemale plate 14 as will be described hereafter. - The male
main body 26 is relatively flat with atop side 34 and abottom side 36 and, in a preferred embodiment, has two screw receiving holes 38. Thescrew receiving holes 38 each have a bowl-shapedbasin 40 on thetop side 34 to receive the heads of the screws 43 and a throughhole 42 through which the main body of the screws 43 pass to come into contact with the vertebral body. The throughholes 42 are configured in a manner that allows the cancellous bone screws 43 to be rigidly fixed to the plate once inserted in bone. The method of fixing the screws 43 to the plate may utilize any number of mechanisms well understood in the art that allow the screws 43 and themale plate 12 to maintain a rigid relationship once the screws 43 are inserted in bone. - The
bottom side 36 of themale plate 12,female plate 14 and interconnectingplate 15 is preferable roughened, thereby allowing the bottom side 22 of theSC device 10 to “grip” the vertebral body when the bottom side 22 of theSC device 10 is brought into contact with and secured to the vertebral body by the interaction of the screws 43 and the body of theSC device 10 as described herein. - As mentioned, the
male plate 12 has acentral protrusion 28 with atop surface 30 and alongitudinal axis 32.Central protrusion 28 is dimensioned to mate with and secure themale plate 12 with the interconnectingplate 15 or thefemale plate 14 as will be described in detail hereafter. Where the interconnectingplate 15 is used, the combined length of thecentral protrusion 28 on themale plate 12 and thecentral protrusion 28′ on the interconnectingplate 15 will be slightly longer than the distance theSC device 10 is intended to provide compression over. -
Central protrusion 28 has aboss 44 extending entirely through it approximately parallel to thetop surface 30 that is designed to mate with a relief cut 62 in the interconnectingplate 15/female plate 14. - The interconnecting
plate 15 combines the features of themale plate 12 and thefemale plate 14 on its opposite ends. As a result, on one end of interconnecting plate there is acentral protrusion 28′ essentially as described in connection with thecentral protrusion 28 ofmale plate 12. On the opposite end ofinterconnection plate 15, there is aprotrusion receiving channel 56 essentially as described hereafter in connection with theprotrusion receiving channel 56 offemale plate 14. In addition, interconnectingplate 15 has at least a pair ofscrew receiving holes 38 essentially as described in connection with thescrew receiving holes 38 of themale plate 12. - The purpose of the interconnecting
plate 15 is to allow theSC device 10 to be secured to three or more adjacent vertebrae and allow theSC device 10 to apply compression across these vertebrae to facilitate healing as described herein. As a result, a single interconnectingplate 15 may be placed between themale plate 12 and thefemale plate 14 and attached to the vertebra between the vertebrae that the male andfemales plates plates 15 can be connected end to end (i.e., theprotrusion receiving channel 56 of one interconnectingplate 15 receives thecentral protrusion 28′ of an adjacent interconnectingplate 15 and the process continues until all the interconnectingplates 15 are joined together) to form an interconnecting span with amale plate 12 and afemale plate 14 attached to the ultimate ends of this chain of interconnectingplates 15. In this embodiment of the invention, each of the interconnectingplates 15 would havescrew receiving holes 38 allowing each interconnectingplate 15 to be attached to a single vertebra by bone screws 43. In a variant of this embodiment, a single interconnectingplate 15 could have several sets ofscrew receiving holes 38 so that this single interconnectingplate 15 could be attached to several adjacent vertebrae or could span a previously fused segment. - The
female plate 14 has a femalemain body 52 with abottom side 54 and aprotrusion receiving channel 56.Protrusion receiving channel 56 is formed between aleft guide 58 and aright guide 60 that extend away from the femalemain body 52.Left guide 58 andright guide 60 each have aninner surface 61, anouter surface 63, abottom surface 65 and atop surface 67.Left guide 58 andright guide 60 are basically rectangular in cross-section withinner surfaces 61 being preferably essentially planar and withouter surfaces 63 being essentially outwardly curved with a series ofridges 71 extending outwardly. On thebottom surface 65 of the left and right guides 58, 60 facing theprotrusion receiving channel 56, there is a relief cut 62 machined to accept theboss 44 on thecentral protrusion 28′ of the interconnectingplate 15 or themale plate 14. -
Protrusion receiving channel 56 is dimensioned to snugly receive thecentral protrusion 28′ with the lockingclamp 16 in place on thecentral protrusion 28′ as will be described hereafter so that thecentral protrusion 28′ is “captured” and held in theprotrusion receiving channel 56 by physical contact between the outer surface of the lockingclamp 16 and the inner surfaces of theleft guide 58 andright guide 60 as well as by the interaction between thecentral protrusion 28′ and theboss 44 on the inferior aspect of thecentral protrusion 28′ and relief cut 62. - The
outer surfaces 63 of the left and right guides 58, 60 contact theinner surfaces 37 of theside protrusions 29 under the influence of the lockingclamp 16, as will be described hereafter, to securely locate thefemale plate 14 with respect to the interconnectingplate 15 and the interconnectingplate 15 with themale plate 12. - The
female plate 14, also in a preferred embodiment, has two screw receiving holes 82. Thesescrew receiving holes 82 receive standard cancellous bone screws 43 that are threaded into the bone of the vertebrae. In similar fashion to screw receivingholes 38, thescrew receiving holes 82 also have a bowl-shapedbasin 84 on the upper surface 78 to receive the heads of the bone screws 43 and a throughhole 86 through which the main body of the bone screws 43 pass to come into contact with the vertebral body. Thethroughholes 86 are configured in a manner that allows the cancellous bone screws 43 to be rigidly fixed to the plate once inserted in bone by the interaction of the screws 43 with thebasins 84. The method of fixing the screws 43 to thefemale plate 14 may utilize any number of mechanisms well understood in the art that allow the screws 43 and thefemale plate 14 to maintain a rigid relationship once the screws 43 are inserted in bone. - The
SC device 10 has alocking mechanism 88. Lockingmechanism 88 converts “active” compression applied by the surgeon using thecompression device 90 described below interacting with thedevice 10 at the time of surgery to “static” compression after surgery. Thelocking mechanism 88 also provides rigid fixation to theSC device 10 to optimize bone healing and preventing further settling from occurring. - The
locking mechanism 88 in one embodiment includes lockingclamp 16 and lockingscrew 18. The lockingclamp 16 has atop surface 92 with ahole 93 extending through it, abottom surface 94,parallel sides 96, alongitudinal axis 97 and aninner channel 99 between theparallel sides 96 and below thetop surface 92. The inner width of theinner channel 99 of the locking clamp 16 (i.e., the inside distance between the parallel sides 96) is such that the lockingclamp 16 will fit snugly over thecentral protrusion 28. The width of the locking clamp 16 (i.e., the distance between the parallel sides 96) is such that the lockingclamp 16 will fit snugly between the left and right guides 58, 60 in theprotrusion receiving channel 56. - A single
large locking screw 18, dimensioned to rotate freely within thehole 93 of the lockingclamp 16, activates thelocking mechanism 88. In the embodiment of the invention shown inFIGS. 1-19 , the lockingscrew 18 has ahead 106, abody 108 and adistal end 110 opposite thehead 106. Thehead 106 has a larger cross-sectional diameter than the threadedbody 108. Thebody 108 is threaded at least on thedistal end 110 to correspond to the threads of the threadedhole 35 in theprotrusion 28. - The
parallel sides 96 of lockingclamp 16 preferably have a series of ridges 46 and valleys 48, preferably placed substantially perpendicular to thelongitudinal axis 97 and tapered from top to bottom, to locate and affix the lockingclamp 16 to the inner surfaces of theleft guide 58 andright guide 60 of the interconnectingplate 15 andfemale plate 14. Through this configuration, the ridges 46 and valleys 48 on thesides 96 of the lockingclamp 16 preferably contact and engage with the inner surfaces of left and right guides 58, 60 in frictional or mechanical contact to precisely locate and affix the lockingclamp 16 within theprotrusion receiving channel 56. Because the series of ridges 46 and 48 are tapered, as the series of ridges 46, 48 are moved into contact with and engage the inner surfaces of left and right guides 58, 60, this engagement adds compressive force to the adjacent vertebral bodies through theSC device 10. The lockingclamp 16 is preferably made of a material that is harder than the material of the interconnectingplate 15 or thefemale plate 14. - The present invention also includes a compression device 90 (
FIGS. 20-23 ) that allows the surgeon to provide active, controlled compression between the two sliding components of the SC device 10 (male plate 12 and female plate 14) at the time of surgery. Thiscompression device 90 allows the surgeon to accurately measure the force applied across the graft by theSC device 10 and allows the surgeon to stop compressing when a predetermined amount of force has been obtained. Since both themale plate 12 and thefemale plate 14 are each connected to adjacent vertebral bodies by two fixed angle bone screws 43, this provides for even, surgeon-controlled compression across the interbody graft. - The
compression device 90 has twoarms handle foot distal end arms pivot 130 that connects therespective arms arms pivot 130, a surgeon squeezing thehandles distal ends device 10, a surgeon squeezing thehandles SC device 10 and thus to adjacent vertebral bodies through the interaction of thefeet male plate 12 andfemale plate 14 as will be explained hereafter. - Each
foot compression device 90 engages themale plate 12 or female plate 14 (or interconnecting plate 15), respectively, to apply pressure to move themale plate 12 andfemale plate 14 toward each other as the physician squeezes thehandles compression device 90 andSC device 10 shown inFIG. 23 , the distal ends 126, 128 offeet pins 132 that protrude from the distal ends 126, 128. - In the embodiment shown in
FIGS. 21-23 , pins 132 protrude fromadaptor plates 134 havingthroughholes 136.Adaptor plates 134 are secured to the distal ends 126, 128 offeet screws 138 that pass throughthroughholes 136. The distal ends 126, 128 offeet secure hole 140 that receives ascrew 138. In this way,adaptor plates 134 are secured to the distal ends 126, 128 offeet adaptor plates 134 may be removed and replaced with hooks protruding from the distal ends 126, 128 offeet female plates top side 34 of themale plate 12 and the top surface 78 of thefemale plate 14. This enables the ends ofcompression device 90 to be modular (i.e., replaceable so that the appropriate end for a desired application can be placed on the compression device 90) with respect to using different techniques to achieve compression. - The
male plate 12 andfemale plate 14 each have anotch SC device 10 and shaped to receive thepins 132 in a snug, conforming fashion so that compression applied to thefeet handles male plate 12 andfemale plate 14, respectively, through the interaction of thepins 132 with thenotches - In an alternate embodiment of the invention, the distal ends 126, 128 of
feet male plate 12 and thefemale plate 14, respectively, through pins 132. However, in this embodiment, thenotches top surfaces 26 and upper surface 78 of themale plate 12 andfemale plate 14, respectively, sized and shaped to receive thepins 132 in a snug fashion so that compression applied to thefeet handles pins 132 to themale plate 12 andfemale plate 14, respectively, through thenotches - The
compression device 90 also preferably has agauge 146 that allows the physician to measure the compression force being applied to theSC device 10, and thus to the vertebral bodies, by the squeezing together of thehandles gauge 146, by quantifying the deflection of thehandles SC device 10. In the embodiment of thecompression device 90 shown inFIG. 20 ,gauge 146 includes anarm 148 attached to pivot 130 and located betweenhandles arm 148 preferably has a circular, oval, square or rectangular cross-section and a horizontal and avertical component arm 148 hasindicia 150 located on at least a portion of thehorizontal component 149. - The
gauge 146 has anindicator 152 that is an annular spacer located along thehorizontal component 149 ofarm 148. Theindicator 152 has acentral opening 154 sized to be approximately the same size and shape as the cross-sectional size and shape of thehorizontal component 149 ofarm 148 so thatindicator 152 is attached to thehorizontal component 149 by sliding thehorizontal component 149 through the firstcentral opening 154. A frictional fit between the firstcentral opening 154 and thehorizontal component 149 holds theindicator 152 in position on thehorizontal component 149. - As mentioned above, when the
handles handles handles vertical component 151 of thearm 148 is rigidly attached to thepivot 130, as thehandles arm 148 and itsassociate indicator 152 does not move. As a result, thehandle 120 will be deflected along thehorizontal component 149 of thearm 148 and along theindicia 150 located on thehorizontal component 149. By observing the location of thehandle 120 with respect to theindicia 150 on thehorizontal component 149, the amount of force applied tohandles feet notches male plate 12 andfemale plate 14, thegauge 146 indirectly measures the compression being applied to the graft, and allows the surgeon to stop compressing once a predetermined force has been achieved. - By placing the
indicator 152 at a desired location on thehorizontal component 149 ofarm 148, the physician can squeeze thehandles handle 120 moves into contact with theindicator 152. At this point, the physician knows that the desired amount of force has been applied to thecompression device 90 and thereby to theSC device 10 to the graft. - In another embodiment of the
compression device 90 shown inFIG. 22 ,gauge 146 again includes anarm 148. But, in this embodiment, thearm 148 is connected to arigid arm 156 located on the outside ofhandle 118.Rigid arm 156 is attached to handle 118 near thepivot 130.Arm 148 extends from therigid arm 156 in the direction that handle 118 moves when it is squeezed together withhandle 120 and may extend through a slot inhandle 118 or may be formed aroundhandle 118 so thatarm 148 extends towardhandle 120. In this embodiment as well,indicator 152 is located betweenhandles - As mentioned above, when the
handles handles handles arm 148 is rigidly attached to therigid arm 156, as thehandle arm 148 and itsassociate indicator 152 does not move. As a result, thehandle 118 will be deflected alongarm 148 and along theindicia 150 located onarm 148. By observing the location of thehandle 118 with respect to theindicia 150 onarm 148, the amount of force applied tohandles feet notches 142. 144 of themale plate 12 andfemale plate 14, thegauge 146 indirectly measures the compression being applied to the graft, and allows the surgeon to stop compressing once a predetermined force has been achieved. Again, by observing the location of thehandle 118 versus the indictor, the surgeon will know that the desired amount of force has been applied to thecompression device 90 and thereby to theSC device 10 to the graft. - An alternative embodiment of the
compression device 90 is referred to as the static compensatingcompressor 590 and shown inFIGS. 24-27 . The static compensatingcompressor 590 utilizes aforce indicator 592 and a method to measure static compressive forces applied by the patient's own anatomy to allow the surgeon to factor the patient's own static compressive forces out to ensure the correct value of the absolute compression applied through theSC device 10 to the vertebral bodies. The static compensatingcompressor 590 includes a turnbuckle 594 that uses a threadednut 596, threadedinserts 598, along with a series of compression springs 600 and guiderods 602, collectively known as the distraction mechanism 604, to allow the surgeon to apply a measurable distraction force (a force in the opposite direction to the compressive force) to unload the vertebral segment. By unload, we mean to take compression pressure, usually applied by the patient's own muscles and ligaments, off the vertebral segments. Once compression pressure on the vertebral segment has been unloaded from the vertebral segment, a null point (i.e., a point where there is no compression or distraction force on the vertebral bodies) is established and therapeutically useful compression can be applied to the vertebral segment at a known rate. - The
force indicator 592 has a central processing unit (CPU) 606 and adisplay 608 to determine and indicate the amount of force applied in either compression or distraction to theSC device 10 and a zeroing function that allows the surgeon to compensate for static anatomical compression. Theforce indicator 592 also includes astrain gauge 610. Theforce indicator 592 is a simple electronic device that measures the resistance across thestrain gauge 610 that is secured to one of thearms compressor 90 and then uses theCPU 606 to determine, by formula or through a lookup table, and indicate the amount of force applied by thecompressor 90 and then indicate this amount of force on thedisplay 608. TheCPU 606 may be an application specific integrated circuit (ASIC), a digitally based central processing unit or discrete components. - The
display 608 is preferably attached to one of thehandles arms CPU 606 and thedisplay 608 are preferably combined into a single unit. However, either or both theCPU 606 and thedisplay 608 may be located remotely from the static compensatingcompressor 590 and theCPU 606 and thedisplay 608 may be located separately from each other. - The
strain gauge 610 is preferably located on adistal end respective arm compression device 90 although the strain gauge may be located anywhere on anarm pivot 130. As the physician applies compression through thecompression device 90 to theSC device 10 and thus to the vertebral bodies by squeezing thehandles compression device 90 together, the distal ends 126, 128 will flex or bend slightly. Thestrain gauge 610 measures this flexing or bending of the distal ends 126, 128 and communicates the value to theCPU 606 where the force value, once determined, indicates the amount of force applied to theSC device 10, and thus to the vertebral bodies, as is well understood in the art. - As mentioned above, the static compensating
compressor 590 is able to apply distraction pressure to the vertebral bodies through the use of a turnbuckle 594 (FIG. 26 ). The threadednut 596 has a pair of threadedholes 612. The threadedholes 612 are threaded in opposite directions (i.e., with right and left handed threads) as is well understood in turnbuckles. The threaded inserts 598 each have a threadedend 614 and a non-threaded end 616 to which aguide rod 602 is attached. Theguide rods 602 are preferably attached to the non-threaded ends 616 throughsprings 600 that have a low spring force.Springs 600, when used, apply a low biasing force to the turnbuckle 594 to remove looseness in the connection between the turnbuckle 594 and thearms guide rods 602 may be attached directly to the non-threaded ends 616. The threaded inserts 598 are also each threaded on their threaded ends 614 in opposite directions (i.e., with right and left handed threads) and are mated with the threadedholes 612 of the threadednut 596 so that as the threadednut 596 is rotated in a first direction, the threadedinserts 598 are drawn into the threadedholes 612 and as the threadednut 596 is rotated in a second direction, the threadedinserts 598 are moved out of the threaded holes 612. As a result, as the threadednut 596 is rotated in a first direction, theturnbuckle 594 expands in length and as theturnbuckle 594 is rotated in a second direction opposite the first direction, the turnbuckle contracts in length. - The
turnbuckle 594 is preferably attached between and applies a preload to thehandles arms compressor 90. However, theturnbuckle 594 may also be attached between and apply a preload to the distal ends 126, 128 of thearms compressor 90. In either embodiment, theturnbuckle 594 is fitted between thearms handles distal ends slots 618, secured withpins 620 or other suitable retaining devices well understood in the art. In a variant of this embodiment, thepins 620 could be quick release pins, allowing the turnbuckle 594 to be quickly removed once the null point is found, as explained below, so that thecompressor 90 would be used thereafter without theturnbuckle 594. - Once the
turnbuckle 594 is attached to thearms nut 596, theturnbuckle 594 expands or contracts (depending on the direction the threadednut 596 is rotated) thereby applying a preload in either a compression or distraction direction to thearms compressor 90 and thus to theSC device 10 and ultimately to the vertebral bodies. This preload allows the vertebral segment that theSC device 10 is spanning to become unloaded or lifted. By “lifted” or “lift-off” we mean that a distraction force has been applied to the vertebral segment by thecompressor 90 andSC device 10 to the point where the distraction force is equal to the anatomical compression force applied to the vertebral segment by the patient's own muscles and ligaments. At this point, called the null point, there is a net zero force applied to the affected vertebral segment so that the affected vertebral bodies separate or “lift-off” of each other slightly which separation is visually ascertained by the physician. - Once lift-off has been determined, and consequently, the null point established, a button is pushed on the
display 608, on theCPU 606 itself or otherwise, including remotely, to alert theCPU 606 that strain measured by thestrain gauge 610 at that point is the null point. As a result, theCPU 606 directs thedisplay 608 to indicate a zero reading at that point. - At this point, the
turnbuckle 594 is preferably removed from thecompressor 90. As theturnbuckle 594 is removed, the patient's anatomical compression force will be applied to the affected vertebral segment. This compression force will be transferred through theSC device 10 to thecompressor 90 where thestrain gauge 610 will measure the anatomically applied compression force and theCPU 606 will direct thedisplay 608 to indicate the anatomically applied compression force. Thereafter, the surgeon applies an additional compressive force to theSC device 10 which additional compressive force will be sensed by thestrain gauge 610 combined with the compressive force applied by the patient's own anatomy. As a result, theCPU 606 will determine the total compressive force applied to the vertebral segment (i.e., the summation of the patient's own anatomical compressive force and the compressive force being applied by the physician by the compressor 90) which total compressive force is displayed on thedisplay 608. The physician then applies the additional compressive force to the vertebral segment until a desired total compressive force for maximum therapeutic value is obtained. - If the
force indicator 592 is set to a null point before distraction pressure is applied to the vertebral segment by theturnbuckle 594, theforce indicator 592 will also indicate the distraction pressure applied to the vertebral segment by theturnbuckle 594. At the point where lift-off occurs, thedisplay 608 will indicate the amount of distraction pressure being applied by the turnbuckle 594 which equals the amount of compression force that is applied by the patient's own anatomy. This amount of compression force is also potentially valuable information in that the amount of compression force anatomically applied by the patient may be used by the physician to determine the overall health and strength of the patient's inherent anatomical compression mechanism. Thereafter, the physician may set theforce indicator 592 to zero as described above to indicate the null point for the application of compression force also as described above. - In a variant to the embodiments of the
compression device 90 described above, asmall cannula 158 is attached to thecompression device 90 at thepivot 130. Thecannula 158 is directed downward toward theSC device 10. Thiscannula 158 is intended to receive aspecial screwdriver 160 that activates thelocking mechanism 88 of theSC device 10 when the desired compression is achieved. Thescrewdriver 160 is inserted through thecannula 158 into the loosenedlocking mechanism 88 as thecompression device 90 engages themale plate 12 andfemale plate 14. Thus, it is possible for the surgeon to maintain compression across the graft with one hand on thecompression device 90, to determine the degree of compression achieved on theSC device 10 by visualizing thecompression gauge 146, and to activate thelocking mechanism 88 of theSC device 10 with the other hand, causing theSC device 10 to become a rigid construct and preventing further movement of the vertebral bodies from occurring. - Alternately, the physician may use the
screwdriver 160 without inserting it through thecannula 158 or may use thescrewdriver 160 in an embodiment of thecompression device 90 that does not include acannula 158. Further, in any of the embodiments of thecompressor 90, thecompressor 90 may be disposable or reusable. - One mechanism of fixing the bone screws 43 to the
male plate 12 at a rigid predetermined angle is described as follows. As mentioned above, bone screws 43 fix themale plate 12, thefemale plate 14 and the interconnecting plate, 15, if present, to the vertebral bodies. The bone screws 43 may be machined, as is common for such screws, with two separate sets of threads, one on the shaft of the screw 43, the second set on the head of the screw 43. These threads are distinct from each other in that they have different pitches and distinct outer diameters. The pitch and outer diameter of the threads on the shaft of the screw 43 are that of a standard cancellous bone screw. In order to engage the mainmale plate 12, the diameter of the head 45 of the bone screw 43 head is significantly larger than the diameter of the threads on the shaft of the bone screw 43. However, the threads on the bone screw 43 are smaller in outer diameter and tighter in pitch than the bore of the screw receiving holes 38. These threads are machined to engage threads of similar pitch and diameter in thescrew receiving holes 38 of themale plate 12. - The
screw receiving holes 38 are machined to project the screw 43 into the vertebral body at a predetermined angle determined to be most advantageous for fixing theSC device 10 to the vertebral bodies. Thus, by engaging the threads on the head 45 of the screw 43 with those in thescrew receiving hole 38, the screw 43 projects into the vertebral body at the predetermined angle and maintains a rigid fixed relationship with themale plate 12. - The interaction between the bone screws 43 and the
SC device 10 described above is one of the many ways that bone screws 43 can be connected to theSC device 10. However, it is well understood in the art that there are other commercially available ways to connect devices like theSC device 10 to vertebrae that could also be used. As a result, it is intended that any method of connecting theSC device 10 to vertebral bone so that there is a rigid fixed relationship between theSC device 10 and the bone may be used with theSC device 10 of the present invention. - The mechanism of fixing the screws 43 to the
female plate 14 at a rigid predetermined angle is similar to the mechanism for fixing the screws 43 to themale plate 12 at a rigid predetermined angle as described above. Again, the bone screws 43 are machined, as is common for such screws, with two separate sets of threads, one on the shaft of the screw 43, the second set on the head of the screw 43. These threads are distinct from each other in that they have different pitches and distinct outer diameters. The pitch and outer diameter of the threads on the shaft of the screw 43 are that of a standard cancellous bone screw. In order to engage thefemale plate 14, the inner diameter of the screw head 45 is significantly larger than the inner diameter of the threads on the shaft. However, the threads on the screw head 45 are smaller in outer diameter and tighter in pitch than the bore of the screw receiving holes 82. These threads are machined to engage threads of similar pitch and diameter in thescrew receiving holes 82 of thefemale plate 14. Thescrew receiving holes 82 are machined to project the screw 43 into the vertebral body at a predetermined angle. Thus, by engaging the threads on the head 45 of the screw 43 with those in thescrew receiving holes 82, the screw 43 projects into the vertebral body at the predetermined angle and maintains a rigid fixed relationship with thefemale plate 14. - The
SC device 10 as described in the embodiment above has the option of using fixed angle screws. However, variable angle screws 43 may be used with theSCD device 10 as long as when these screws 43 are placed through themale plate 12,female plate 14 or interconnectingplate 15 into bone, their relationship with therespective plate plates - Most currently available non-adjustable plates have the option to place screws into the bone at a variety of different angles to obtain optimum purchase. While this is necessary to position static plates, it is not necessary in the
SC device 10. In fact the sliding capability that theSC device 10 has in the unlocked arrangement renders the common use of variable screws superfluous. Nevertheless, any type of screw may be used with theSC device 10 as long as a mechanism exists for rigidly fixing the screw to the plate. - The importance of having screws 43 that are rigidly fixed to the
male plate 12 andfemale plate 14 at a predetermined angle is that compression occurs through the entire SC device 10 (the sliding components of the SC device 10 (male plate 12 andfemale plate 14 and the two rigidly attached screws), rather than through the screws individually. Also, as mentioned, thebottom side 36 of themale plate 12 and thebottom side 54 of thefemale plate 14, and of the interconnectingplate 15 if present, are roughened, allowing theSC device 10 to “grip” the vertebral body. These characteristics in combination provide for a much larger surface area to compress against (the contact of thebottom side 36 andbottom side 54 on the anterior surface of the vertebrae as well as the two rigidly fixed bone screws in themale plate 12 andfemale plate 14, respectively). This results in a much more even compression against the entirety of the interbody graft and minimizes the potential for screw cutout or bony failure. - For purposes of illustrating the operation of locking
mechanism 88 of the invention in the embodiment shown inFIGS. 1-14 , a variant of the embodiment described above will be used. In this variant, shown inFIGS. 15-17 , there is no interconnectingplate 15. Instead, themale plate 12 andfemale plate 14 intermesh directly through the interaction of thecentral protrusion 28 andside protrusions 29 of themale plate 12 and the left and right guides 58, 60 of thefemale plate 14. In describing the operation of theSC device 10, it is to be understood that the concepts described apply as well to the interaction between themale plate 12 and one end of the interconnectingplate 15 and the interaction between the opposite end of the interconnectingplate 15 and thefemale plate 14. - In use, the
central protrusion 28 is inserted into the protrusion receiving channel 56 (FIG. 15 ). Becauseprotrusion receiving channel 56 is dimensioned to receivecentral protrusion 28 with the lockingclamp 16 in place,central protrusion 28 is precisely located and retained within theprotrusion receiving channel 56. In this position with the lockingclamp 16 in place on thetop surface 30 ofcentral protrusion 28, the ridges 46 and valleys 48 on theparallel sides 96 of lockingclamp 16 come into loose contact with theinner surface 61 ofleft guide 58 andright guide 60 of thefemale plate 14. (FIG. 15 ) The lockingscrew 18 is passed through thescrew hole 93 so that itsdistal end 110 comes into contact with and is threaded into the threaded hole 35 a sufficient amount to locate thedistal end 110 of the lockingscrew 18 in the threadedhole 35 but not a sufficient amount to deform the lockingclamp 16. - Bone screws are passed through the
screw receiving holes basins male plate 12 andfemale plate 14, respectively. - The
compression device 90 is then used to apply the desired compression to theSC device 10. Thepins 132 are placed in thenotches handles male plate 12,female plate 14 and interconnectingplate 15 if present, and thereby to the vertebral bone through the bone screws. - As mentioned above, where a
gauge 146 is present, the amount of compressive force applied to thedevice 10 can be ascertained. - As shown in
FIGS. 16 and 17 , when themale plate 12 is moved into an intermeshing position with thefemale plate 14 and the appropriate amount of compression is applied to theSC device 10 through thecompression device 90, thescrewdriver 160 is coupled to thehead 106 of the lockingscrew 18. Thescrewdriver 160 is rotated so that the threadedbody 108 of lockingscrew 18 is threaded into the threadedhole 35. The lockingscrew 18 is then screwed further onto thecentral protrusion 28 on themale plate 12 so that thehead 106 contacts thetop surface 92 of the lockingclamp 16. - Once the
head 106 has contacted thetop surface 92, further rotation of the lockingscrew 18 will cause the head to be forced into the material of thetop surface 92 of the lockingclamp 16. This will cause the lockingclamp 16 to interfere so that theparallel sides 96 will be forced into engaging and locking contact with theinner surfaces 61 of the left and right guides 58, 60 on thefemale plate 14 or the interconnectingplate 15. This outward compression from the interference fit is transferred through the left and right guides 58, 60 to cause engaging and locking contact between theouter surface 63 of the left and right guides 58, 60 and theinner surface 37 of theside protrusions 29. The interaction between thehead 106 and thescrew hole 35 locks the lockingclamp 16 against the right and leftguides male plate 12 is secured with respect to thefemale plate 14, thecompression device 90 is removed. As a result, the compression applied to theSC device 10 through thecompression device 90 will be locked to the vertebral bone through themale plate 12 and female plate 14 (and interconnectingplate 15 if used) because these various components are locked in a fixed relationship to each other. - An alternate embodiment of the
locking mechanism 88 is shown inFIGS. 28-32 and is described as follows. In this embodiment there is no lockingclamp 16 and the locking screw 18 (FIG. 30 ) is large in diameter and is tapered from thehead 106 to thedistal end 110 so that the diameter of thehead 106 is significantly larger than the diameter of thedistal end 110. In addition, the diameter ofhead 106 of the lockingscrew 18 is greater than the width of thecentral protrusion 28. Further, the threadedhole 35 of thecentral protrusion 28 of themale plate 12 is fashioned in a threaded tapered fashion so that the lockingscrew 18 fits into the threadedhole 35. In this embodiment thecentral protrusion 28 may include aslot 41 through which the threadedhole 35 passes to allow maximal deformation of thecentral protrusion 28 along the length of thecentral protrusion 28. - Thus, when appropriate compression has been applied to the vertebral bodies by the
SC device 10, thelocking mechanism 88 is engaged by advancing the lockingscrew 18 into the threadedhole 35. The advancement of the lockingscrew 18 into the threadedhole 35 deforms the outer aspect of thecentral protrusion 28 which surrounds the threadedhole 35 thereby causing this portion of thecentral protrusion 28 to expand and interfere with theinner surface 61 ofleft guide 58 andright guide 60 of thefemale plate 14. The presence of theslot 41 helps the deformation of the outer aspects of thecentral protrusion 28 by making it easier for the two sides of thecentral protrusion 28 to move away from the threadedhole 35 under the influence of the lockingscrew 18. This outward compression from the interference between expandedcentral protrusion 28 and left and right guides 58, 60 is transferred through the left and right guides 58, 60 to cause engaging and locking contact between theouter surfaces 63 of the left and right guides 58, 60 and theinner surface 37 of theside protrusions 29. - It should be noted that the
SC device 10 is a modular and expandable device. The characteristics of this device allow it to be disassembled in vivo and expanded to immobilize adjacent vertebral segments (or other bone pieces or segments) by the insertion of one ormore interconnecting plates 15 to form an interconnecting span as described above. - Thus, should subsequent surgery be required, as for example, in the case of adjacent segment disease (the segment adjacent to a fused segment undergoing accelerated degeneration), it is not necessary to expose the entirety of the
SC device 10 and remove it to extend the fusion to the adjacent segment (as is the case with nearly all current plates). Instead, an end portion of the SC device 10 (e.g., either themale plate 12 or female plate 14) may be removed (leaving the remainder of theSC device 10 intact), the fusion completed and theSC device 10 simply expanded to include the newly fused segment by inserting one or more interconnectingplate 15, then reapplying the end portion (either themale plate 12 orfemale plate 14, respectively) of theSC device 10 to the newly fused vertebrae, applying compression as explained herein and locking and securing theSC device 10. - An alternate embodiment of the
SC device 10 is shown inFIGS. 33-35 . In this embodiment, the lockingscrew 18 of thelocking mechanism 88 is modified to include acam 162 that rotates around the lockingscrew 18 below the head 106 (FIG. 35 ). Further, the edges of channel 80 form a track 164 (FIG. 34 ) dimensioned to receive and constrain thecam 162 within thetrack 164 in a relatively conformal manner. In addition, in this embodiment of thelocking mechanism 88, there is no lockingclamp 16 and thecentral protrusion 28 does not have the protrusion ridges 50. -
Cam 162 is relatively disk shaped with elongated opposedouter edges 166. Theouter edges 166 resemble somewhat a “V” with the bottom of the V being farther from thebody 108 than the open mouth of the V which rotates around thebody 108 of lockingscrew 18. The lockingscrew 18 in this embodiment rotates freely with respect tocam 162. However, the cam portion can be rotated into contact with and engage thetrack 164 when rotated 90 degrees about thebody 108. When the lockingscrew 18 is in the unlocked position, themale plate 12 is inserted into theprotrusion receiving channel 56. With thecam 162 rotated so that thecam 162 does not contact thetrack 164, thecam 162 and the lockingscrew 18 move easily into the channel 80. Then themale plate 12 and thefemale plate 14 are moved to the desired position relative to each other, thecam 162 is rotated 90 degrees so that thecam 162 contacts the wall of thetrack 164 where such frictional contact prevents themale plate 12 from moving relative to thefemale plate 14. In addition, though both the lockingscrew 18 and thefemale plate 14, including thetrack 164 are preferably made of titanium, the lockingscrew 18 is of a significantly harder grade. In this way, as the lockingscrew 18 is rotated 90 degrees, because thecam 162 is present and has a cam shape, thecam 162 is forced into thetrack 164, effectively deforming thecam 162 and forming a “cold weld” with thetrack 164. In this way, a rigid, permanent fixation between the lockingscrew 18 and themale plate 12 to which it is attached and thefemale plate 14 throughtrack 164 is achieved and compression is maintained. TheSC device 10 in this embodiment is also designed to work with thecompression device 90. - An alternate embodiment of the
SC device 10 in a preferred embodiment shown inFIGS. 36-54 also has amale plate 12 and afemale plate 14. In addition, theSC device 10 in this embodiment also has alocking plate 316 and a lockingscrew 318 that, in combination with standard cancellous bone screws (not shown) fix theSC device 10 to the patient's vertebrae. ThisSC device 10 has atop side 320, abottom side 322 and opposed medial sides 324. - The
male plate 12 has a malemain body 326 and aprotrusion 328 extending away from the malemain body 326. Theprotrusion 328 has atop surface 330 and alongitudinal axis 332. The malemain body 326 is relatively flat with atop side 334 and abottom side 336 and, in a preferred embodiment, has two screw receiving holes 338. Thescrew receiving holes 338 each have a bowl-shapedbasin 340 on thetop side 334 to receive the heads of the screws and a throughhole 342 through which the main body of the screws pass to come into contact with the vertebral body. The throughholes 342 are machined to have a rigid relationship with the bone screws as will be described hereafter. - The
bottom side 336 ofmale plate 12 is preferably roughened, thereby allowing thebottom side 336 ofmale plate 12 to “grip” the vertebral body when thebottom side 336 is brought into contact with and is secured to the vertebral body by the interaction of the screws and the malemain body 326 as described above. - As mentioned, the
male plate 12 has aprotrusion 328 with atop surface 330 and alongitudinal axis 332.Protrusion 328 is dimensioned to mate with and secure themale plate 12 with thefemale plate 14 as will be described in detail hereafter. The length ofprotrusion 328 along thelongitudinal axis 332 is chosen to be slightly longer than the distance theSC device 10 is intended to provide compression over. -
Protrusion 328 has aslot 344 extending entirely through it approximately perpendicular to thetop surface 330.Protrusion 328 also has a series of alternatingridges 346 andvalleys 348, collectively protrusionridges 350, located on a portion of itstop surface 330.Ridges 350 are preferable angled slightly with respect to thelongitudinal axis 332 for a purpose to be explained hereafter. - The
female plate 14 has a femalemain body 352 with abottom side 354 and aprotrusion receiving channel 356.Protrusion receiving channel 356 is comprised of aleft channel 358, aright channel 360 and a connectingpiece 362.Left channel 358 is basically “C” shaped with atop piece 370,bottom piece 372 and anouter piece 374. Althoughleft channel 358 has been described as having atop piece 370,bottom piece 372 andouter piece 374,left channel 358 is preferable a single contiguous piece although it could be made of these separate segments connected together. -
Right channel 360 has atop piece 370, abottom piece 372 and anouter piece 374. Althoughright channel 360 has been described as having atop piece 370,bottom piece 372 andouter piece 374,right channel 360, likeleft channel 358, is preferably a single contiguous piece although it could be made of these separate segments connected together. - Connecting
piece 362 connects theleft channel 358 to theright channel 360 at the respectivebottom pieces 372. In the preferred embodiment, connectingpiece 362 is integrally formed with thebottom pieces 372 although it could be made of these separate segments connected together. Connectingpiece 362 has a threadedhole 376 that extends into connectingpiece 362. -
Protrusion receiving channel 356 is dimensioned to snugly receive theprotrusion 328 so that theprotrusion 328 is “captured” and held in theprotrusion receiving channel 356 by relatively conformal physical contact between the outer surface of theprotrusion 328 and the inner surfaces of theleft channel 358,right channel 360 and connectingpiece 362. - The female
main body 352 also has anupper surface 378 and achannel 380 formed in theupper surface 378 between theleft channel 358 and theright channel 360.Channel 380 extends entirely through theupper surface 378. - The
female plate 14, also in a preferred embodiment, has two screw receiving holes 382. Thesescrew receiving holes 382 receive standard cancellous bone screws (not shown) that are threaded into the bone of the vertebrae. In similar fashion to screw receivingholes 338, thescrew receiving holes 382 also have a bowl-shapedbasin 384 on theupper surface 378 to receive the heads of the bone screws and a throughhole 386 through which the main body of the bone screws pass to come into contact with the vertebral body. Thethroughholes 386 are machined to provide a rigid relationship with the bone screws. TheSC device 10 has a locking mechanism 388. The locking mechanism 388 includes lockingplate 316 and lockingscrew 318 as well as theridges 346 andvalleys 348 on thetop surface 330 ofprotrusion 328 of themale plate 12 and the threadedhole 376 andchannel 380 offemale plate 14 as described below. Locking mechanism 388 converts “active” compression applied by the surgeon using thecompression device 90 described above interacting with theSC device 10 at the time of surgery to “static” compression after surgery. The locking mechanism 388 also provides rigid fixation to theSC device 10 to optimize bone healing and preventing further settling from occurring. - The locking
plate 316 has a top surface 392, abottom surface 394 andparallel sides 396. The bottom surface of lockingplate 316 preferably has a series ofridges 398 andvalleys 400, collectively lockingridges 402, of similar dimensions to theridges 346 andvalleys 348 of theprotrusion 328 to locate and affix thelocking plate 316 to theprotrusion 328 as will be described hereafter. In a most preferred embodiment of the invention, theridges 346 andvalleys 348 of theprotrusion 328 and theridges 398 andvalleys 400 of thelocking plate 316 are angled slightly with respect to thelongitudinal axis 332. Through this configuration, theridges 398 andvalleys 400 of thebottom surface 394 of thelocking plate 316 preferably contact and engage with theridges 346 andvalleys 348 of theprotrusion 328 in frictional or mechanical contact to precisely locate and affix thelocking plate 316 to theprotrusion 328. Further, as shown in FIGS. 42 and 48-53, because theprotrusion ridges 350 and the lockingridges 402 are angled, as the lockingplate 316 is moved from one side of thechannel 380 to the other, as the lockingridges 402 seat with theprotrusion ridges 350, themale plate 12 is moved into compression with thefemale plate 14. This compression is transferred through themale plate 12 andfemale plate 14 to the vertebral bone. - The width of the locking plate 316 (i.e, the distance between the parallel sides 396) is such that the locking
plate 316 will fit snugly into thechannel 380 formed in theupper surface 378 of thefemale plate 14 of theSC device 10 but still allow thelocking plate 316 to move in a direction perpendicular to theparallel sides 396 within thechannel 380. - Locking
plate 316 has aslot 404.Slot 404 is aligned withchannel 344 of theprotrusion 328 and allows a lockingscrew 318, as explained hereafter, to pass through both theslot 404 and mate with the threadedhole 376 as described hereafter.Slot 404 is also dimensioned to conformally mate with thehead 406 ofscrew 318 so that contact between thehead 406 and slot 404 as the lockingscrew 318 is threaded into threadedhole 376 moves the lockingridges 402 into contact with theprotrusion ridges 350. - A single
large locking screw 318, dimensioned to rotate freely within theslot 404 of thelocking plate 316, activates the locking mechanism 388. In the embodiment of the invention shown inFIGS. 36-54 , the lockingscrew 318 has ahead 406, a threadedbody 408 and adistal end 410 where thehead 406 has a larger cross-sectional diameter than the threadedbody 408. - In use, the
protrusion 328 is inserted into the protrusion receiving channel 356 (FIGS. 39 and 48 ). Becauseprotrusion receiving channel 356 is dimensioned to conformally receiveprotrusion 328, protrusion is precisely located and retained within theprotrusion receiving channel 356. Lockingplate 316 is placed on thetop surface 330 ofprotrusion 328 within thechannel 380 so that theprotrusion ridges 350 come into contact with the locking ridges 402 (FIG. 49 ). The lockingscrew 318 is passed through theslot 404 so that itsdistal end 410 comes into contact with and is threaded into the threaded hole 376 a sufficient amount to locate thedistal end 410 of the lockingscrew 318 in the threadedhole 376 but not a sufficient amount to secure the lockingridges 402 of thelocking plate 316 into secure contact with the protrusion ridges 350 (FIGS. 50-51 ). - Bone screws are passed through the
screw receiving holes basins male plate 12 andfemale plate 14, respectively. - The
compression device 90 is then used to apply the desired compression to theSC device 10. Thepins 132 are placed in thenotches handles male plate 12 andfemale plate 14 and thereby to the vertebral bone through the bone screws. As mentioned above, where agauge 146 is present, the amount of compressive force applied to theSC device 10 can be ascertained. Once the desired amount of compressive force is applied to theSC device 10, thescrewdriver 160 is coupled to thehead 406 of the lockingscrew 318. Thescrewdriver 160 is rotated so that the threadedbody 408 of lockingscrew 318 is threaded into the threadedhole 376. In this process, the lockingridges 402 are brought into secure contact with theprotrusion ridges 350. But, to secure an optimum fit between the lockingridges 402 and theprotrusion ridges 350, it may be necessary to move thelocking plate 316 from side to side within thechannel 380 until they mate optimally and impart a compression on themale plate 12 and female plate 14 (FIG. 52 ). Once this optimal mating occurs, thescrewdriver 160 is rotated further. The interaction between thehead 406 and theslot 404 locks the lockingplate 316 against theprotrusion 328. Lockingscrew 318 is tightened into the threadedhole 376 so that themale plate 12 is securely positioned with respect to thefemale plate 14. Oncemale plate 12 is secured with respect to thefemale plate 14, thecompression device 90 is removed. - Another alternate embodiment of the
SC device 10 is shown inFIGS. 55-56 . In this embodiment, theSC device 10 is as described above except that theSC device 10 has aspring mechanism 168 integral between the ends of themale plate 12 andfemale plate 14 that provides a near constant force applied to a fixed vertebral segment (or segments) through a standard buttressing or tension band construct.Spring mechanism 168 has three parts, a relativelyflat spring plate 170, guide pins 184, 186 and aguide plate 172.Spring plate 170 has ends suitable for attaching to bone via one or more bone screws. -
Spring 178 is preferably a plurality of flexible members that resist being moved in a lateral direction, in this case, in the direction of moving the oneplate end 174 away from theother plate end 176. In a preferred version of this embodiment, thespring 178 is a plurality of flat serpentine shaped members made of a spring metal such as spring steel. However, thespring 178 could also be made of a single member that has spring-like attributes and could be made of materials other than metal so long as the elements ofspring 178 possess the ability to resist stretching according to a linear restoring force (i.e., follows Hooke's law). -
Guide plate 172 reinforcesspring plate 170 and provides over extension protection as well as flexion/extension moment buffering. Over extension protection is provided byguide pins spring plate 12 via slots and limit the extension of thespring 178. Flexion/extension is controlled by theguide plate 172 in close contact with thespring plate 12. - This embodiment of
SC device 10 allows theSC device 10 to settle into position on the vertebral bone and minimize the deflection of themale plate 12 and thefemale plate 14 without a drastic reduction in theSC device 10's ability to provide a consistent tension force. Further, after theSC device 10 is implanted, the surgeon can determine the actual level of compression by measuring the overall change in length of the construct and applying Hooke's law to determine the relative rate of compression. - Another feature of an embodiment of the invention shown in
FIG. 57 is that of a series oftrial spacers 202 that include a strain gauge capable of measuring compressive strain through electromagnetic techniques as are well understood in the art. Thesespacers 202 are preferably cylindrical in shape with a handle which allows them to be inserted between the vertebral bodies. The spacers are machined to have the approximate dimensions of the bone graft which is to be placed between adjacent vertebrae (in the disc space once the disc has been removed). This embodiment also includes ahandle 204 attached to thespacer 202 in order to allow the surgeon ease in facilitating insertion and extraction of thespacer 202. The cylinders of thespacer 202 are preferably machined in height increments (e.g. one millimeter) in order to accommodate a variety of disc space heights. - The
spacer 202 serves two purposes. First, it enables the surgeon to “size” the disc space in order to place an appropriate sized graft, in the same manner that many allograft spacers currently have “trials”. Second, eachspacer 202 has the characteristics of a strain gauge which is able to directly measure the “passive” force applied to thatspacer 202 by the adjacent vertebral bodies, once thespacer 202 is inserted. In this way the surgeon may estimate the approximate “passive” force which would be applied to a similar sized bone graft. The total force applied to that graft, then, would be the sum of the passive force applied to the graft (as measured by the spacer of similar dimensions) and the active force applied by the surgeon through thecompression device 90. Thus, by using the strain-gauge spacer 202 in conjunction with thecompression device 90, the surgeon may obtain an accurate assessment of total force applied to the graft. This is beneficial in that it allows further study of the “optimal” force which must be applied in order to reliably achieve fusion. - In all the embodiments shown, the
SC device 10 is a unique device that utilizes Wolff's law to compress two or more adjacent cervical vertebrae while fusion between the vertebrae occurs by allowing static, rigid compression to be applied to interbody graft in the cervical spine. Static, rigid compression has definitively been shown to increase bony union in a long bone fracture model. Lumbar interbody fusions have been shown to heal at a higher rate than intertransverse fusions, presumably because of the constant loading of the graft. No other currently available cervical device allows for active, static compression. - It should be noted that use of the
SC device 10 is by no means limited to use in the cervical spine. Any of the aforementioned embodiments, in a somewhat larger version or having a curved bottom side 22 (FIG. 58 ) as will be clear to those skilled in the art, may be used for the same or similar purposes in the thoracic or lumbar spine, or in instances where static compression is desired outside of the spine (e.g., and without limitation, bone fractures, as for example, of long bones like the femur or bones of the skull, hip or scapula) (FIG. 59 ). - In the thoracic spine a larger version of the
SC device 10 may be placed on the side of the thoracic spine (as opposed to the front) in order to facilitate approach to the thoracic spine and to avoid large vascular structures that reside immediately in front of the thoracic spine. - In the lumbar spine, a larger version of the
SC device 10 may be placed either on the side of the spine to facilitate exposure and avoid vascular structures or directly on the front of the spine, especially at the lumbosacral junction. It is believed that in order to obtain anterior fusion at L5-S1, it is important to have a fully contoured SC device 10 (FIG. 58 ) that is simply comprised of amale plate 12 and afemale plate 14 with a curved bottom side 22 matching the curvature of the vertebral segments in the L5-S1 region. - As mentioned above, the
SC device 10 may be used to obtain union of fractures, nonunions, osteotomies and other bony defects in regions other than the spine. In the embodiment suited for use with other bones, theSC device 10 should be sized appropriately to the bone and have the option of placing more than twoscrews 138 on either side of the defect where union is desired (FIG. 59 ). TheSC device 10 allows for maximum utilization of Wolff's Law to facilitate healing in that reproducible measurable compression is applied in each of these scenarios to obtain bony union. -
FIG. 60 is a perspective view of an embodiment of the static compression device designed to be used to treat fractures. The reference numerals correspond to elements described in other embodiments above. Reference numerals designed with a prime symbol simply refer to the same element disposed in a different structural configuration. - An
alternative embodiment 700 of the static compression device for treating spinal fractures is illustrated in top perspective view inFIG. 61 , with bottom perspective view inFIG. 62 . Eachdevice 700 has afirst end plate 702, acenter plate 704, and asecond end plate 706, thesecond end plate 706 being of the same design as thefirst end plate 704;end plates FIG. 63 and bottom perspective view inFIG. 64 , andcenter plates 704 are illustrated in more detail in top perspective view inFIG. 65 and bottom perspective view inFIG. 66 . Eachend plate 702 has acavity portion 703 that surrounds aprotrusion portion center plate 704 and is attached to thecenter plate 704 with alock screw FIG. 67 ; lock screws 708, 710 engage withthreads protrusion portions center plate 704.Protrusion portions multiple valleys multiple ridges 724 ofend plates multiple valleys multiple ridges 724 when the end plates are drawn into contact with the centerplate protrusion portions 718 718 by tension of tightenedlock screw end plates protrusion portions -
FIG. 68 is a top perspective view of analternative embodiment 800 derived from the embodiment ofFIG. 61 but having additional levels for treating spinal fractures of multiple vertebrae. In the embodiment ofFIG. 68 , anend plate 802 engages a protrusion portion (hidden by end plate 802) of a daisy-chain plate 804 and is secured to the protrusion portion bylock screw 806. The daisy-chain plate 804 differs from thecenter plate 704 in that one protrusion portion, such asprotrusion portion 718 is replaced by an equivalent 808 of acavity portion 703 of anend plate 702. Inembodiment 800, multiple daisy-chain plates center plate 704 and an end plate likeend plate 706 as illustrated inFIG. 69 . In theembodiment 800 illustrated, where two daisy-chain plates end plate 814 having a protrusion portion (concealed withincavity portion 812 of daisy chain plate 810) instead of a cavity portion is used to terminate the string of plates. - In the embodiments of
FIG. 61-69 , in order to retain end plates, center plates, and daisy-chain plates together and simplify handling during surgery, pins 730 (FIG. 62 ) are driven into holes 732 (FIG. 66 ) of the center plate, the pins engaging in slots 734 (FIG. 62 ) of the endplate cavity portion 703. Similarly,cavity portions 808 of daisy-chain plates 804 and engaging protrusion portions of daisy chain plates and/orend plate 814 are pinned together (FIG. 69 ), although these pins are not visible in the top view ofFIG. 69 . These pins serve to limit relative motion of the plates. - As with the other embodiments, the embodiments of
FIG. 61-69 have twoholes 760 in each ofend plates center plate 704, and daisy-chain plates 804 such that screws may be inserted inholes 760 to attach the plates to bone. Each hole has an interior circumferential slot (not shown) into which anoptional snap ring 762 may be fitted. In an embodiment having pre-attached screws, screws are used that have a head, a distal threaded portion, and a proximal unthreaded portion near the head having diameter less than an outer diameter of the distal threaded portion such that a screw can be inserted into eachhole 760 and retained withsnap ring 762. In embodiments having pre-attached screws, the proximal unthreaded portion is sufficiently long that the device can be placed on bone and the screws inserted into tapered holes in bone. - In each device of the embodiments of
FIG. 61-69 , anotch 770, recess, or hole is provided in at least two plates, and in some embodiments all plates, of the device such that a separate device, such as that ofFIG. 22 , can be coupled to the plates and applied to exert compressive force on the plates, thereby sliding the protrusions of each male plate into cavities of the mating female plates into a compressed position, and thus applying compressive forces on the bones or bone fragments to which they are attached, before tightening lock screws 708, 718 to hold the plates in compressed position. The embodiments ofFIG. 61-69 illustrate anotch 770 in end plates for this purpose, other embodiments, including variations of the embodiments ofFIG. 61-69 , may have additional holes, hooks, or notches in both the end plates and intermediate plates so that compressive forces can be applied across plate-to-plate boundary, representing a bone-to-bone boundary, individually. - The
SC device 10 described herein has the following four unique characteristics which together provide for static compression of the vertebral body-graft interface: -
- The use of fixed-angle screws to secure the
SC device 10 to the vertebral bodies; - The use of a compression device to apply and measure the pressure applied to the vertebral bodies by the
SC device 10; - The technique of using active, static compression to assist the fusion process; and
- The use of a
locking mechanism 88 that maintains compression during the fusion process to facilitate bone growth. These four characteristics of theSC device 10 are not currently found in any other spinal device. As a result, it is believed that theSC device 10 in any of the disclosed embodiments provides an optimal environment for spinal fusions to consolidate while preventing frequent non-unions and occasional deformities seen with the use of current dynamic plates.
- The use of fixed-angle screws to secure the
- The
SC device 10 in several embodiments has been described in detail above. However, it is to be understood that the specific features of the various components may be modified as will occur to those skilled in the art and still fall within the parameters of the invention. For example, the specific cross-sectional shape of theprotrusion 28, left and right guides 58, 60 andside protrusions 29 may be modified so long as these components interlock with each other as described herein. Further, the shape of the lockingclamp 16 may be modified so long as it is able to be deformed to force frictional or mechanical contact between the various components as described above. - Further, the invention has been described as having a
protrusion 28 withside protrusions 29 on amale plate 12 or interconnectingplate 15 and aleft guide 58 andright guide 60 on afemale plate 14 or interconnectingplate 15. It is clear that the invention could also be practiced with themale plate 12 or interconnectingplate 15 having asingle protrusion 28 with thefemale plate 14 or interconnectingplate 15 still having theleft guide 58 andright guide 60. Also, theSC device 10 could have two ormore protrusions 28 on themale plate 12 or interconnectingplate 15 with a corresponding number ofprotrusion receiving channels 56 to receive theseprotrusions 28 and a corresponding number of locking clamps 16. - The present invention has been described in connection with certain embodiments, configurations and relative dimensions. It is to be understood, however, that the description given herein has been given for the purpose of explaining and illustrating the invention and are not intended to limit the scope of the invention. For example, complimentary versions of the mating aspects of the
SC device 10 could be formed and still be within the scope of the invention. In addition, it is clear that an almost infinite number of minor variations to the form and function of the disclosed invention could be made and also still be within the scope of the invention. Consequently, it is not intended that the invention be limited to the specific embodiments and variants of the invention disclosed. It is to be further understood that changes and modifications to the descriptions given herein will occur to those skilled in the art. Therefore, the scope of the invention should be limited only by the scope of the claims.
Claims (9)
1. A device for compressing two or more adjacent bones or bone fragments, comprising:
a male plate having at least a first protrusion extending away from the male plate along a longitudinal axis in a first direction, the male plate having holes adaptable for insertion of screws to attach the plate to a first one of the two or more adjacent bones;
a first female plate having a cavity substantially parallel to the longitudinal axis, the cavity being adapted to receive the first protrusion when the male plate is aligned with the first female plate, and the first female plate has holes for attachment to a second one of the two or more adjacent bones; and
a first locking mechanism comprising a plurality of shapes selected from the group consisting of ridges and valleys formed on the protrusion of the male plate, and a mating plurality of shapes selected from the group consisting of ridges and valleys formed on a surface of the cavity of the first female plate, and a screw adapted to engage threads of the protrusion of the male plate and hold the surface of the cavity of the first female plate to the protrusion of the male plate thereby engaging a plurality of the ridges and valleys;
wherein at least two plates of the device have a feature for coupling a compressing tool to the plate.
2. A device of claim 1 wherein the male plate is engaged with the first female plate, where the screw is adapted to slide in a slot of the female plate, and wherein at least one pin of the protrusion of the male plate extends into a slot of the female plate and adapted to retain the protrusion of the male plate in engagement with the cavity of the female plate.
3. A device of claim 1 wherein the male plate is a double-male plate having a second protrusion extending away from the male plate in a second direction along the longitudinal axis, and further comprising:
a second female plate having a cavity substantially parallel to the longitudinal axis, the cavity being adapted to receive the at least one protrusion when the male plate is aligned with the female plate, and the second female plate has holes for attachment to a third one of the two or more adjacent bones; and
a second locking mechanism comprising a plurality of shapes selected from the group consisting of ridges and valleys formed on the protrusion of the male plate, and a mating plurality of shapes selected from the group consisting of ridges and valleys formed on a surface of the cavity of the second female plate, and a second screw adapted to engage threads of the protrusion of the male plate and hold the surface of the cavity of the second female plate to the protrusion of the male plate thereby engaging a plurality of the ridges and valleys.
4. A device of claim 1 wherein the male plate is engaged with the first and second female plates, where the first screw is adapted to slide in a slot of the first female plate, and the second screw is adapted to slide in a slot of the second female plate, wherein at least one pin of the first protrusion of the male plate extends into a slot of the first female plate and is adapted to retain the protrusion of the male plate in engagement with the cavity of the first female plate, and wherein at least one pin of each of the second protrusion of the male plate extends into a slot of the second female plate and is adapted to retain the second
5. A device of claim 4 wherein the second female plate is a daisy-chain plate having a protrusion aligned with the longitudinal axis and configured to engage within a cavity of a third female plate; the device further comprising:
a third locking mechanism comprising a plurality of shapes selected from the group consisting of ridges and valleys formed on the protrusion of the second female plate, and a mating plurality of shapes selected from the group consisting of ridges and valleys formed on a surface of the cavity of the third female plate, and a screw adapted to engage threads of the protrusion of the male plate and hold the surface of the cavity of the first female plate to the protrusion of the male plate thereby engaging a plurality of the ridges and valleys.
6. A device of claim 1 wherein the male plate is a daisy-chain plate having a second cavity extending away from the male plate in a second direction along the longitudinal axis, and further comprising:
a second male plate having a protrusion substantially parallel to the longitudinal axis, the second cavity being adapted to receive the protrusion of the second male plate when the daisy-chain plate is aligned with the second male plate, and the second male plate has holes for attachment to a third one of the two or more adjacent bones; and
a second locking mechanism comprising a plurality of shapes selected from the group consisting of ridges and valleys formed on the protrusion of the second male plate, and a mating plurality of shapes selected from the group consisting of ridges and valleys formed on a surface of the cavity of the daisy-chain plate, and a second screw adapted to engage threads of the protrusion of the daisy-chain plate and hold the surface of the cavity of the daisy-chain plate to the protrusion of the second male plate thereby engaging a plurality of the ridges and valleys.
7. A device of claim 6 wherein the male plate is engaged with the first female plate, where the screw is adapted to slide in a slot of the female plate, and wherein at least one pin of the protrusion of the male plate extends into a slot of the female plate and adapted to retain the protrusion of the male plate in engagement with the cavity of the female plate.
8. A device of claim 6 wherein the first male plate and first female plate have features permitting attachment of a compression device configured to apply compressive force sliding the protrusion of the first male plate into the cavity of the first female plate.
9. A method of fusing bones comprising:
Providing a fixation device further comprising:
a male plate having at least a first protrusion extending away from the male plate along a longitudinal axis in a first direction, the male plate having holes adaptable for insertion of screws to attach the plate to a first bone portion;
a first female plate having a cavity substantially parallel to the longitudinal axis, the cavity being adapted to receive the first protrusion when the male plate is aligned with the first female plate, and the first female plate has holes for attachment to a second one of the two or more adjacent bones; and
a first locking mechanism comprising a plurality of shapes selected from the group consisting of ridges and valleys formed on the protrusion of the male plate, and a mating plurality of shapes selected from the group consisting of ridges and valleys formed on a surface of the cavity of the first female plate, and a screw adapted to engage threads of the protrusion of the male plate and hold the surface of the cavity of the first female plate to the protrusion of the male plate thereby engaging a plurality of the ridges and valleys;
wherein at least two plates selected from male and female plates of the device have a feature adapted for attachment of a compressing tool;
attaching each plate of the device to bone;
attaching a compressing tool to the device;
applying force to the device with a compressing tool, the force acting to slide the protrusion of the male plate into a compressed position in the cavity of the female plate and apply compressive force to bone; and
tightening the screw of the first locking mechanism to retain the male and female plate in compressed position.
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US12/694,179 Expired - Fee Related US7901440B2 (en) | 2006-04-03 | 2010-01-26 | Method of compressing adjacent pieces of bone |
US13/709,864 Abandoned US20130165934A1 (en) | 2006-04-03 | 2012-12-10 | Static Compression Device |
US14/525,095 Abandoned US20150045793A1 (en) | 2006-04-03 | 2014-10-27 | Static Compression Device |
US15/391,499 Expired - Fee Related US10398477B2 (en) | 2006-04-03 | 2016-12-27 | Static compression device |
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US13/709,864 Abandoned US20130165934A1 (en) | 2006-04-03 | 2012-12-10 | Static Compression Device |
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US8328853B2 (en) | 2012-12-11 |
US20130165934A1 (en) | 2013-06-27 |
US7901440B2 (en) | 2011-03-08 |
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WO2007126622A3 (en) | 2008-07-17 |
WO2007126622A2 (en) | 2007-11-08 |
US10398477B2 (en) | 2019-09-03 |
EP2007321A4 (en) | 2012-04-04 |
EP2007321B1 (en) | 2016-05-11 |
US20100082029A1 (en) | 2010-04-01 |
US20170112545A1 (en) | 2017-04-27 |
WO2007126622A8 (en) | 2007-12-21 |
US20100114176A1 (en) | 2010-05-06 |
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