CA2109077A1 - Method for subcutaneous suprafascial pedicular internal fixation - Google Patents
Method for subcutaneous suprafascial pedicular internal fixationInfo
- Publication number
- CA2109077A1 CA2109077A1 CA002109077A CA2109077A CA2109077A1 CA 2109077 A1 CA2109077 A1 CA 2109077A1 CA 002109077 A CA002109077 A CA 002109077A CA 2109077 A CA2109077 A CA 2109077A CA 2109077 A1 CA2109077 A1 CA 2109077A1
- Authority
- CA
- Canada
- Prior art keywords
- bone
- disc
- dilator
- fixation
- advancing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
-
- 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
-
- 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
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
- A61B17/7007—Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
-
- 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
- A61B17/7049—Connectors, not bearing on the vertebrae, for linking longitudinal elements together
-
- 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
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
- A61F2002/2839—Bone plugs or bone graft dowels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/448—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/449—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple spinal implants located in different intervertebral spaces or in different vertebrae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
Abstract
A method for internal fixation of vertebra (10) of the spine to facilitate graft fusion includes steps for excising the nucleus of an affected disc, preparing a bone graft, instrumenting the vertebrae for fixation, and introducing the bone graft into the resected nuclear space. Disc resection is conducted through two portals (26a and 26b) through the annulus (15), with one portal supporting resection instruments and the other supporting a viewing device. The fixation hardware includes bone screws (30), fixation plates (40), engagement nuts (42), and linking members (44). In an important aspect of the method, the fixation plates, engagement nuts and linking members are supported suprafascially but subcutaneously so that the fascia (22) and muscle tissue (23) are not damaged. The bone screw (30) is configured to support the fixation hardware above the fascia (22). In a further aspect of the invention, a three component dilator system (50) is provided for use during the bone screw implantation steps of the method.
Description
93/1~722 1 ~1 09 0 7 7 PCT/US92/1033' METHOD FOR Sl1BCUTAN~OUS SV~RAFASCIA~ :
PEDlCULAR INTERNAL FlXA'rlON
BACKGROUND OF THE INVENTION
The present invention concerns a method for internal fixation of vertebra of the spine.
It has long been known that intern~l fixation is an adjunct to fusion, such as a transverse process fusion. In ear]y prior art techniques, a surgeon rnade an incision in the patient's back and separated tissue and muscle in order to -expose a wide area of the spine in whi~l the procedure was to .. . .
take place. The fusion and fixation in one prior art process is by grafting bone segments between opposing transverse processes of adjacent vertebrae. However, this tecl~nique resulted in gross destruction of normal anatomy as well as 15 ~lig~l blood loss. Moreover, tllis surgical technique did not ;-completely stabilize the vertebra since there was no direct connection between the vertebral bodies.
In more recent times, a surgical technique known as dowel interbody fusion has been developed. In this technique, bores are formed in disc tissue through either open surgery or percutaneous surgery. A dowel is made to fit into the bores formed in the disc tissue. In still a further technique, all disc tissue is removed between adjacent vertebrae, as well as the disc plates. Large surface area bone grafts are then placed within the clean space to form a graft between the opposing vertebral bodies. In each of these latter two prior art processes it still remains necessary to provide some means for fixation to facilitate ! fusion of the large area bone graft or the dowel to the vertebrae Many types of instrumentation for performing spinal , :.
PEDlCULAR INTERNAL FlXA'rlON
BACKGROUND OF THE INVENTION
The present invention concerns a method for internal fixation of vertebra of the spine.
It has long been known that intern~l fixation is an adjunct to fusion, such as a transverse process fusion. In ear]y prior art techniques, a surgeon rnade an incision in the patient's back and separated tissue and muscle in order to -expose a wide area of the spine in whi~l the procedure was to .. . .
take place. The fusion and fixation in one prior art process is by grafting bone segments between opposing transverse processes of adjacent vertebrae. However, this tecl~nique resulted in gross destruction of normal anatomy as well as 15 ~lig~l blood loss. Moreover, tllis surgical technique did not ;-completely stabilize the vertebra since there was no direct connection between the vertebral bodies.
In more recent times, a surgical technique known as dowel interbody fusion has been developed. In this technique, bores are formed in disc tissue through either open surgery or percutaneous surgery. A dowel is made to fit into the bores formed in the disc tissue. In still a further technique, all disc tissue is removed between adjacent vertebrae, as well as the disc plates. Large surface area bone grafts are then placed within the clean space to form a graft between the opposing vertebral bodies. In each of these latter two prior art processes it still remains necessary to provide some means for fixation to facilitate ! fusion of the large area bone graft or the dowel to the vertebrae Many types of instrumentation for performing spinal , :.
2 PCT/US92/1033~
2109~77 -2-fixation are known in the ar~. For il1stance, spine instrumentation developed by Harrington incorporates a hook ~nd rod configuration. Implantatioll of the Harrington spinal instrumentation requires subperiosteal stripping of the spine 5 to avoid injury to the muscular nerves and vessels.
Dissection of the muscle tissue is also required. In some aspects of the early Harrington techniques, the spine was stripped clean of the supraspinous and intraspinous ligaments.
Later developed techniques involve hardware which is placed through the skin and through the m~scle into the bone. Some of the fi~ation hardware remains outside the body, but is removed after the fusion has been completed.
Techniques of this sort are characterized by high risk of pin tract infection and incisional morbidity.
Thus far, each of the prior art spinal fixation and/or fusion techniques have been characterized by excessive invasion into the patients spine and back region. What is needed is a technique ~hich allows for adequate stabilization of the spine, yet decreases the chance of infection as well as patient morbidity. There is further a need for such a method which permits percutaneous removal of the fixation hardware as an outpatient procedure after fusion has been completed.
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' `') 93/18722 2 1 ~ 9 o 7 7 PCr/US92/1033 SUMMARY OF TI~E INVE:NTION
Th~ pIesent inventioll contemplates a peLcut aneo~ls fUSiOII
technique using subcutaneous suprafascial interrla1 fi~ation.
More particularly, ~he minimally invasive technique of ~lle present invention permits anterior fusion of the disc space of the lumbar spine following appropriate disc resection and bone grafting. The fixation process is suprafascial, that is above the muscle fascia, but subcutaneous, that is beneath the surface of the skin. Thus, none of the muscle tissue is destroyed and the subcutaneous nature of the procedure greatly decreases the risk of pin tract secretions or infections, or the potential of osteomyelitis.
In more specific aspects of the invention, the technique contemplates first resecting the intranuclear cavity of a damagéd disc, including ablation of the superior and inferior end plates. Bone graft material is prepared for introduction into the vacated disc space. Prior to introduction of tlle bone graft into the empty disc nuclear space, fixation instrumentation is implanted. In general, this fixation hardware can include self-tapping cannulated bone screws, fisation plates and linking members for laterally fixing plates on opposite sides of the spinous process.
In tlle preferred IQethod, guide wires are illserted bilaterally in line with and into the pedicle. Pedicle 25 screws are advanced over the guide wire and engaged into a -~
predrilled bore in the pedicle. After the guide wire is removed, the skin is elevated and tissue in the suprafascial subcutaneous space is dissected to permit insertion of the fixation plates. The appropriate plates are first engaged over the ipsilateral screws and then the procedure is repea~ed for the contralateral bone screws at each level of hardware, that is at each vertebra to be stabilized. The bilateral fisation plates can be laterally connected by dissecting across the midline between corresponding screws ~
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Wo93/lg722 PCT/US92/1033-210907~ _4_ and then positioning a linking member between the screws using a top-loadil1g inser~ion mechanism. A nut is also ~op-loaded on to each successive screw to secure the linkin~
members to the plate and to secure the plate to the pedicle screws.
In the inventive method, the nuts engaging the pedicle screws are initially loosely threaded onto the screws. The bone screws are then advanced into the verte~ral body until the hardware resides below the level of the skin, but suprafascially in the subcutaneous space at each level of the .
instrumentation. The nuts are then tightened when they fixation hardware is in its final resting spot. Once the fixation instrumentation is in position, the bone graft material is introduced through a cannula to the disc space and moved into position by an obturator. With the bone graft in place and the spinal fixation hardware engaged to the approp~riate vertebrae, the subcutaneous tissue is then irrigated and closed.
In another aspect of the invention, a cannulated fisation or bone screw is provided which is well suited for use with the~inventive method. More specifically, the screw includes a distal threaded shank and a proximal nut threaded stem which terminates in a driving hub. The distal threaded shank includes self-tapping bone engagin~ threads. Intermediate ~25 the threaded shank and the stem is a smooth shank of sufficient length so that only the smooth shank contacts muscle tissue when the fixation instrumentation is in place.
Near the stem end of the smooth shank is a mounting hub which supports~ the fi~ation plate before the nut is engaged on the 30~ t~hreaded stem. The smooth shank prefera~ly accounts for about one-half of the length of the screw as measured from the tip of the bone engaging threaded shank to the underside of the mounting hub.
In a further aspect of the invention, a three component dilator system is provided to facilitate instrumentation of . ~
:~ .
'~'~93/1872~ PCT/US92/1033~
, 21~J907~l '' the vertebrae. In particular, the dilator sysLen1 includes three concentrically dispose~ hollow dilator tubes, each ~apered at its respective end for atraumatic introduction into the patient. Each of the thre~ dilators is successively s smaller in diameter but laryer in length. The intermediate and smallest dilator tubes have knurled ends to grasp for removal during steps oE the met11od.
It is one object of the present inventiorl to provide a ~-method for internal fi~ation of the spinal column which is ~-minimally invasive and which poses a minimal health risk to the patient. Another object is to provide such a technique which further permits subcutaneous removal of the temporarily impla11ted hardware in an out-patient procedure.
A further object of the invention is realized by the present technique which contemplates subcutaneous but suprafascial fixation to avoid damage to the spinal musculature and ligaments. Further obJects and certain - advantages of the present invention will become apparent from the following description o the invention.
WO93/18722 PCTtUS92/1033--2 1 0 9 ~ 7 ~ DESCRIPTION ~F THE ~RAW~NGS
, E~IG l. is a section view through the spinal colulnn of a patient shown after ilnplantation of fixation instrume1-tation using the method of the present invention.
FIG. 2 is a side view of a bone screw adapted for use in the method of the present invention.
FIG. 3 is a posterior view of the spinal column of the patient after implantation of fixation instrumentation using the method of the present invention, showing bilateral fixation with linking members across the spinal midline, as viewed beneath the skin but with the muscle tissue removed to expose details of the underlying vertebrae.
FIGS. 4A-C are side views of the components of a three component dilator system for use with the method of the present invention during steps for implanting the bone screw into a vertebra.
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:;: ' "'~93/1~722 2 1 o 9 o 7 7 PCT/US9~/1033~ ~
~ESCRIPTION OF 'I'HE PREFERREn EM~O~IMEN'r ~:
For the purposes of promoting an ullderstanding of the prirlciples of the inverltioll, reference will IIOW be made to -- the enlbodimellt illustrated ill the ~I-awings and specific lanyuage will be used to describe the same. It will nevertheless be understood tllat no li~nitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications o the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to wh~ch the inven~ion relates.
The present invention first contemplates steps for a percutaneous fusion technique, such as may be used to fuse adjacent vertebrae after disc tissue has been removed.
According to the preferred embodimellt of the invention, the ~
method is cohducted on lumbar vertebrae, although it is ~-believed to be adaptable to other portions of the spine. The ~;patient, after appropriate preparation, is positioned prone 20 on a~ radiolucent padded frame which allows far both AP -(anterior/posterior) and lateral fluoroscopic visualization during the~entire~procedure. A~l initial AP fluoroscopic view ~-is taken with an external guide pin placed parallel to the plane of the end-plates of the affected disc to assure the 25 proper orientation of the procedure relative to the disc -space. A guideline is drawn on the AP radiograph along the guidepin image to demarcate the plane of entry.
In the preferred embodiment of the fusion technique of the pre.ser1t method, a bi-portal approach is utilized to clean out ~the disc nuclear space. Entry points for local anesthesia are located bilaterally from the midlille, nominally about ten centimeters bilaterally from the radiograph guideline (varying between 8 centimeters for a `~
sma~ller patient to 12 centimeters for a larger patient).
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W093/18722 PCT/~'S92tlO33-210 9 07 rl After t}le fascia and intrafascia Inusculature are appropriately anesthetized, discography is performed usin~ a ~wo-needle technique bilaterally. Pursuant to the preferred method, the initial needle entry point to the disc anrlulus is located on the mid-pedicle line on the AP radiograph, which is defined ~y the line created by the midportion of the pedicle above and below the disc space being irlstrumented.
Both needles are advanced into the posterior central portion of the nucleus and triangulation is begun. The discography is performed to confirm the nature of the disc disease and the contained verses the uncontained condition of the involved disc structure. (An uncontained disc is a disc which has ruptured through the posterior longitudinal ligament and/or annulus, which therefore allows a free flow of dye from the intranuclear space into the epidural space.) The procedure of the preferred method continues with the introduction of cannulae into the disc space. The hubs of the discogram needles can be removed and then serve as guide wires for the cannulae. Dilating probes are place over the 20 guide wires bilaterally into the annulus of the disc. .
Sheaths are placed over the probes over which progressively larger cannulae can then be advanced to dilate the annulus to an appropriate diameter for intradiscal work. Again, this prior procedure is performed bilaterally at the two entry 25 points described above, and is repeated for each affected disc.
In one aspect of the method, a visualization scope is place through each cannula to verify the annulus an~1 to confirm the anatomy under the cannula. If no nerve tissue is observed and the annular tissue is present, a trephine is introduced after the visualization scope has been removed.
The annulus is perforated and successively sized trephines are used to open an annular hole of adequate dimension for the purpose of disc removal and extra-discal visualization.
Once the trephine operation is complete at each bilateral ~93/18722 PCT/US92/1033~
21 0 .9 0 17 g entry point, two portals are provided. Disc resec~ion can be conducted through one portal w~lile a verifying sco~e can be placed at the other portal. Trian~ula~ioll of the di~c material through one portal is considered achieved when direct visualization of the disc resecting instrument occurs through the viewing portal. The intranuclear cavity of ~he affected disc is completely resected and the superior and inferior end-plates are ablated using cutting and sucking instruments or through the use of laser-assisted ~robes. The instruments may be removed from each portal and transposed for complete resection of the disc nucleus. Rapid disc r' removal instruments for the nucleus and rapid burring de~ices for the end-plates can be used to resect the tissues in preparation for fusion. The instruments may also be used to lS resect the posterior ligamentus structures and the in~erannular ring to create an adequate cavity for introduction of the bone ~raft. Acceptable devices include - burrs, laser, curettes and gauges for the ablation of the .
end-plate tissues to the state of bleeding bone. Both rigid -and flexible scopes can be used for the verification of the complete resection of the intranuclear cavity. Once the disc material has been completely cleared out of the cavity and the end-plates completely ablated, and obturator is placed in each cannula to prevent contamination during this succeeding ~25 portions of the procedure.
At this point Qf the preferred technique of the present invention, bone graft harvesting is undertaken. The bone -~
graft harvesting can be accomplished according to any k~o~rn I techniques suitable for this purpose. In one specific embodimènt of the inventive methocl, after appropriate anes~hesia and analgesia, a small incision is made over either posterior superior iliac crest to expose the outer crest for bone harvesting. The bone is procured from the corticocancellous table and prepared for t11e grafting ~`
process. The bone graft is fashioned to be accommodated WO93/1872~ PCT/US92/1033~
21~)9~)7~ -lO-within the inner dialneter of tl~e largest outer canl1ula employed during the disc resectiorl described above. T}le bor1e may be nlixed with other componen~s, inclu~ing osteoinductive proteins or morphogenic materials. ~rhe bone harvest cite is then irrigated, dried and closed over a small drain.
The next step of the inventive process, t~le instrumentation step, occurs under direct fluoroscopy. Under AP fluoroscopic view, a guide wire (preferably a 0.0~2 guide wire is introduced with tlle sharp end of the guide wire being inserted into the skin at a position slightly offset from the area to be cannulated. In one specific embodiment, the guide wire is introduced one centimeter lateral to the area to be cannulated. The position of the guide pin is verified by fluoroscopy angled to 15 degrees in line with the pedicle.
The guide pin is used to palpate the cortex o~er the pedicle and is then secured by tapping with a mallet to prevent movement of the pin until further advancement is desired.
After the guide pin has been locked into the cortex, tissue dilators are applied to protect the surrounding muscle 20 tissue. The guide pin is then advanced, under lateral -~
fluoroscopic view, into the pedicle and within the vertebral body. The position of the pin is confirmed using both AP and fluoroscopy views. This procedure is repeated for each pedicle o the vertebra. Thus, for eac~l vertebra to be ~25 instrumented, a pair of guide pins are positioned at about a lS angle from the midliIIe and along each pedicle of the vertebra.
After the guide pin insertion process is complete, an incision is made at the guide pin insertion site, which, in 30 one specific embodiment, is about 2.0 cm. in length. Then, ~-using pick-ups and Metzenbaum scissors, subcutaneous tissue is dissected suprafascially. Metzenbawn scissors are also used to dissect the suprafascial subcutaneous tissues rom the ipsilateral pin across the midline to the contralateral guide pin. Dissection o~ this tissue provides space for ~"1)93tl~722 2l09n77 PCI`/US92/1033 connection of pedicle screws ir~ subsequent steps of the method.
~ In t~le llext step of tlle inven~iv~ met~lod, a three c~mponent tissue dilator system is used to dilate t}le tissue 5 at eacll guide pin to accept first a cannulated drill bit and ~hell a larger diameter cannula~ed self-tapping bone screw.
T~le dilator system comprises t~lree tapered tubes of increasing diameter and decreasing length. The tubes are ;
introduced successively from smallest diameter to largest diameter to provide adequate access tbrough the tissue for later steps of the method. After the three component tissue dilator system has been inserted, the smallest of tlle internal dilators is removed allowing for insertion of the drill bit along the guide pin. The bit is used to drill into the initial one-third of the pedicle. The bit is removed and tlle int2rmediate tissue dilator is then removed, leaving the largest dilator still in place. The self-tapping bone screw is inserted through the largest dilator over the guide wire until it is advanced to at least 50% depth of the pedicle.
After~the~position of the bone screw has been confirmed by la~teral fluoroscopy, the guide wire is removed and the screw advanced until the proximal tip of the screw is at the level of the skin incision. This procedure is repeated for each pedicle in each successive vertebra until all the bone screws ~ ... .
~25 are~in place for~the final internal fixation instrumentation.
In-;one specific embodiment, the cannulated drill bit has an~outer~diameter of 4.5 ~n, while the cannulated bone screw can~have a diameter between 5.5-8.5 mm. Thus, in this specificlembodiment, the intermediate dilator of the ~hree : .~
30; c~mponént`dilator systen~ has an internal diameter of at least ; 4.5~mm, and preferably 5.2 ~n to receive the drill bit ~theret~hrough. Likewise, the largest dilator has an internal diameter at least larger than the bone screw, and preferably 9.6~n to acco~nodate a range of bone screw diameters.
Pick-ups are again used to elevate the skin and : : :
WO93/1872~ PCT/US92/1033~
Metzenbaum scissors are used to disse~t any renlaining subcutaneous suprafascial tissue ~s required to accommo~ate rl1sertion of an elonga~ed fixation plate. An appropriately sized fixation plate i5 inserted using forceps through the 2.0 cm. incisions. It is unders~ood tlat the fixation plates are sized to fit over bor1e screws engaged in the pedicles of adjacent vertebrae to provide adequate fixatior1 at each si~e of the spinous process. The fixation plates for tl~e ipsilateral screws are first inserted by forceps and then the procedure is repeated for the contralateral side at each vertebral level requiring instrumentation. In addition, `
linking members are inserted through the incision at the ipsilateral guide pin and passed across the midline in the subcutaneous space to engage the ipsi- and contra- lateral bone screws to accomplish trans-lateral linkage. The linking member can be of the type sold by Danek Medical, Inc., assignee of the present invention, as its CROSSLINKTM
product. Once each of the fixation plates and linking members have been engaged over the appropriate bone screws, a nut is applied in a top-loaded fashion to loosely secure the hardware together. -After each nut is initially threaded onto its corresponding screw, the bone screws are advanced as necessary so that all of the fixation hardware lies ~25 subcutaneously, but suprafascially, at each level of the instrumentation. Once each of the bone screws has reached its ~final resting place within the vertebra, and once all tlle instrumentation, including the fixation plates and linking members, is within the appropriate suprafascial subcutaneous space, the nuts are tightened, while the bone screws are held, at each successive level, thus creating a firm interlock between all of the components oE the fixation system. AP and Iateral fluoroscopic views can document the final position of the hardware to the satisfaction of the operating surgeon.
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~"~93/1872' 2 1 0 9 0 7 7 PCT/US92/1033-Once the fixatiorl instru1l1entatio1~ has been inserted, each ~o1le screw insertion cite is th~roug~l]y irriga~ed as well as t~he su~cutaneous space which has accepted the fixa~ion components. The incisions ~re dried and hemostasis verified followed by closure of the incision with subcutaneous absorbable sutures.
With the fixation hardware in place, attention is returned ~o ~he prior portals through which the disc resection was conducted. In this step of the method of the present invention, the obturators are removed from the portals and the previously harvested bone graft material is introduced through one cannula into the disc space. A
visualizing scope is extended through the cannula ir~ the other portal for confirmation of entry of the bone grat into the disc space. A smooth obturator is inserted into the cannula to facilitate advancement of the bone graft material through the cannula into the empty disc nuclear space. After the ipsilateral portal has been completely filled with bone graft material, the same procedure is performed at the contralateral portal. ~isual verification of the grafting procedure in the contralateral portal is not possible because the first portal has been filled by graft material. However, fluoroscopy can be used to identify the introduction of the obturator into the disc nuclear cavity, thereby confirming ~25 the location of the bone graft material. Upon completion of the grafting process, the cannulae are removed, the subcutaneous tissue irrigated and t11e discography entry points are closed with absorbable sutures.
With'the foregoing description of the inventive method in ....
3a mind, attention is directed to tle figures. In FIG. l, a cross-sectional view of a vertebral region of a patient Sl10WS
a vertebra l0 having pedicle portions ll. In this superior section view, a disc is shown with its arlnulus 15 intact but with an empty nuclear space 16 after the disc tissue has been resected. Fixation hardware is shown at only one side of the WO93/187'2 PCT/US92/1033``
21~9077 -14-midline ML defined ~y the spillous process of ~lle vertebra ~.
lO. However, as depicted in FIG. 3, fixation instrumenta~ion ls implanted on either side of t~1e nlidline ML. FIG. 3 ~urt11er shows ~ixation between adjacent verte~rae, identified as vertebra lO and lO', with corresponding body portions lOa, transverse processes lOb and lOc, spinous processes lOd, and laminae lOe.
The entry sites 25a and 25b shown in FIG. l are used in the disc resection steps of the method. FIGS. l and 3 show the location of the portals 26a and 26b through which~the disc annulus is removed and the bone graft material ~-introduced. As described above, the entry sites 25a and 25b :-are nominally lO.0 cm bilaterally from the midline ML. The portals 26a and 26b are oriented so that the disc resection tools can be inserted below the transverse processes lOc of the vertebra at the level of the nerve root.
Referring again to FIG. l, the skin 20 of the patient is shown dissected from the fascia 22 protecting muscle tissue 23 to provide a suprafascial subcutaneous space 25. An incision 27 is shown through which the fixation hardware is inserted in accordance with the method described above. The fixation hardware includes a bone screw 30, which is preferably a pedicle screw. A fixation plate 40 is mounted on the screw 30, held in place by a nut 42. In the posterior -~25 view of FIG. 3, ~the fixation hardware is also shown as including linking members 44 spanning across the midline ~between corresponding bone screws 30.
As~can be seen most clearly in FIG. l, the method of the present i~lvention provides a technique for instlumentir1g adjacent vertebra to facilitate fusion. Implantation of the fixation instrumentation according to the inventive method ~; causes minimal invasion to the patien~, with the insertion occurring throuyh a single incision, like incision 27, -;
~; aligned with each pedicle. Most significantly, the hardware resides within the suprafascial subcutaneous space 25 so that ~ .
93/18722 ~ Q 7 7 PCT/US92/1033 destruction of muscle tissue is not required. With ~his method, patient mor~idity rates are reduces, while healir~
r~ates are improved. Since the fixation hardware resides above the muscle layer, removal can be conducted in an out-~atient procedure under a local anesthetic.
Referring now to FIG. 2, the details of a bone screw ,,, particularly adapted for t~le present met~lod is shown. The screw 30 includes a distal threaded shank 31, which in the preferred embodiment is configured as a self-tapping pedicle screw in accordance with known technology. The proximal end of the screw 30 includes a machine threaded stem 34, which is ', threaded for engagement with the nut 42 used to fix the fixation plate 4U and linking member 44. The stem 34 terminates in a driving hex recess 35 which is engaged by an ;~, appropriate screw driving tool as known in the art.
(Alternatively, a hex projection can be used in lieu of the recess 35, with an appropriate change in the screw driving tool.) Intermediate the distal shank 31 and proximal stem 34 is a smooth shank portion 32. The smooth shank portion 32 defines a hub 33 near the proximal threaded stem 34. The hub 33 includes a surface 33a configured to support the fixation plate 40. When the nut 42 is tightened onto the proximal stem 34, the fixation plate 40 is locked between the nut and ~25 the hub surface 33a. The hub 33 supports the fixation plate to keep it within the suprafascial space ,25. The surface 33a is preferably slightly curved to fit within a scalloped fixation plate of known design in the art. The screw 30 is cannulated along its entire length, as represented by the bore 36 provided for guidewire insertion.
The smooth shank portion 32 provides a non-irritating surface for contacting the fascia and muscle tissue. The length of the smooth shank portion 32 is determined by the muscle thickness around the instrumented vertebra, and is generally equal in length to the length of the bone engaging W093/I8722 PCT/US9~/1033 thLeaded2 ~0 ~~1~. In orle spe~ific elllbodilllent, the screw 30 has a length measured from the tip of the bone engaging shank 31 ~o the underside of the mounting hu~ 33 of 65-75 mln. The bone engaging distal shank 31 has a nonlinal lengtll of 35 mm which provides optimum engagement with the vertebra. The smooth shank portion 32 accounts for the remainder of ~he 65-75 n~l length~ or between 30-40 mm. The ma~hine threade~
stem 34 has a length, as measured from surface 33a of the mounting hub 33, that is sufficient to acc~Imnodate the fixation plate 40, a nut 42 and a linking member 44. In the specific embodiment, the length of the machine threaded stem 34 is 10-15 ~n so that very little of the stem projects beyond the nut. The bone screw 30 can have a diameter of between 5.5-8.5 mm as required for the patient and fixation ;
procedure. It is understood, of course, that the specific dimensions are illustrative of a nominal bone screw ;-configuration. These dimensions can be varied as required ~-~
for a particular patient or procedure, while still adhering to the basic concept~ of the present illven~ion.
Referriny now to FIGS. 4A-C, the components of a three component dilator system 50 are shown. As described above, the dilator system is used to acilate implantation of the bone screw 30 into the vertebrae of the patient. The system 50 includes three successively smaller and longer dilator ~25 tubes 51, 56 and 61. Each dilator tube is tapered at its respective tip 53, 58 and 63 for atraumatic introduction of the tubes through the skin and tissue of the patient. Each of the tubes is cannulated or hollow as represented by ~-respective bores 52, 57 and 62 therethrough. The bore 52 in the thinnest dilator tube 51 has a diameter sufficient to accept a guidewire therethrough. The bore 57 in the intermediate dialneter dilator tube 56 has a diameter slightly larger than the outer diameter of the dilator tube 51.
Likewise, the bore 62 in the largest diameter dilator tube 61 is slightly larger than the outer diameter of tbe dilator tube 56.
~93/1872~ 21 0 9 o 7 7 PCT/~S92t1033 T~le ends of the slnallest and intermediate diameter tubes~;
51 and 56, ends 54 and 59 respectively, are knurled to provide a gripping surface for removal of ~he tubes. lile lengths of the tubes are graduated so that the smallest diameter tube 51 has the greatest length, while the intelmediate tube 56 has is longer than the outermost laryer diameter dilator tube 61. This length differential also facilitates sequential removal of the tubes 51 and 56, just prior to and just after the vertebra has been drilled in the lO instrumentation step of the method. ~-In one specific embodiment of the three component dilator system 50 of the present invention, the smallest diameter dilator tube 51 has an outer diameter of about 5 mm, a length of 152.5 mm, and a cannulated bore diameter of about 2 ~n.
~he intermediate dilator tube 56 has an outer diameter of 9.4 mm, a length of about 140.0 mm, and a cannulated bore diameter of 5.15 mm (leaving 0.15 mm clearance for insertion of the tube 51). The final dîlator tube 61, through which the bone screw 30 is inserted, has an outer diameter of 11.1 mm, a length of 127.0 mm and a cannulated bore diameter of 9.58 mm to receive the intermediate dilator tube 56, as well as the bone screw 30, therethrough.
While the invention has been illustrated and described in detail in the drawings and foreyoing description, the same is 25 to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the inventioh are desired to be protected.
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2109~77 -2-fixation are known in the ar~. For il1stance, spine instrumentation developed by Harrington incorporates a hook ~nd rod configuration. Implantatioll of the Harrington spinal instrumentation requires subperiosteal stripping of the spine 5 to avoid injury to the muscular nerves and vessels.
Dissection of the muscle tissue is also required. In some aspects of the early Harrington techniques, the spine was stripped clean of the supraspinous and intraspinous ligaments.
Later developed techniques involve hardware which is placed through the skin and through the m~scle into the bone. Some of the fi~ation hardware remains outside the body, but is removed after the fusion has been completed.
Techniques of this sort are characterized by high risk of pin tract infection and incisional morbidity.
Thus far, each of the prior art spinal fixation and/or fusion techniques have been characterized by excessive invasion into the patients spine and back region. What is needed is a technique ~hich allows for adequate stabilization of the spine, yet decreases the chance of infection as well as patient morbidity. There is further a need for such a method which permits percutaneous removal of the fixation hardware as an outpatient procedure after fusion has been completed.
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' `') 93/18722 2 1 ~ 9 o 7 7 PCr/US92/1033 SUMMARY OF TI~E INVE:NTION
Th~ pIesent inventioll contemplates a peLcut aneo~ls fUSiOII
technique using subcutaneous suprafascial interrla1 fi~ation.
More particularly, ~he minimally invasive technique of ~lle present invention permits anterior fusion of the disc space of the lumbar spine following appropriate disc resection and bone grafting. The fixation process is suprafascial, that is above the muscle fascia, but subcutaneous, that is beneath the surface of the skin. Thus, none of the muscle tissue is destroyed and the subcutaneous nature of the procedure greatly decreases the risk of pin tract secretions or infections, or the potential of osteomyelitis.
In more specific aspects of the invention, the technique contemplates first resecting the intranuclear cavity of a damagéd disc, including ablation of the superior and inferior end plates. Bone graft material is prepared for introduction into the vacated disc space. Prior to introduction of tlle bone graft into the empty disc nuclear space, fixation instrumentation is implanted. In general, this fixation hardware can include self-tapping cannulated bone screws, fisation plates and linking members for laterally fixing plates on opposite sides of the spinous process.
In tlle preferred IQethod, guide wires are illserted bilaterally in line with and into the pedicle. Pedicle 25 screws are advanced over the guide wire and engaged into a -~
predrilled bore in the pedicle. After the guide wire is removed, the skin is elevated and tissue in the suprafascial subcutaneous space is dissected to permit insertion of the fixation plates. The appropriate plates are first engaged over the ipsilateral screws and then the procedure is repea~ed for the contralateral bone screws at each level of hardware, that is at each vertebra to be stabilized. The bilateral fisation plates can be laterally connected by dissecting across the midline between corresponding screws ~
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Wo93/lg722 PCT/US92/1033-210907~ _4_ and then positioning a linking member between the screws using a top-loadil1g inser~ion mechanism. A nut is also ~op-loaded on to each successive screw to secure the linkin~
members to the plate and to secure the plate to the pedicle screws.
In the inventive method, the nuts engaging the pedicle screws are initially loosely threaded onto the screws. The bone screws are then advanced into the verte~ral body until the hardware resides below the level of the skin, but suprafascially in the subcutaneous space at each level of the .
instrumentation. The nuts are then tightened when they fixation hardware is in its final resting spot. Once the fixation instrumentation is in position, the bone graft material is introduced through a cannula to the disc space and moved into position by an obturator. With the bone graft in place and the spinal fixation hardware engaged to the approp~riate vertebrae, the subcutaneous tissue is then irrigated and closed.
In another aspect of the invention, a cannulated fisation or bone screw is provided which is well suited for use with the~inventive method. More specifically, the screw includes a distal threaded shank and a proximal nut threaded stem which terminates in a driving hub. The distal threaded shank includes self-tapping bone engagin~ threads. Intermediate ~25 the threaded shank and the stem is a smooth shank of sufficient length so that only the smooth shank contacts muscle tissue when the fixation instrumentation is in place.
Near the stem end of the smooth shank is a mounting hub which supports~ the fi~ation plate before the nut is engaged on the 30~ t~hreaded stem. The smooth shank prefera~ly accounts for about one-half of the length of the screw as measured from the tip of the bone engaging threaded shank to the underside of the mounting hub.
In a further aspect of the invention, a three component dilator system is provided to facilitate instrumentation of . ~
:~ .
'~'~93/1872~ PCT/US92/1033~
, 21~J907~l '' the vertebrae. In particular, the dilator sysLen1 includes three concentrically dispose~ hollow dilator tubes, each ~apered at its respective end for atraumatic introduction into the patient. Each of the thre~ dilators is successively s smaller in diameter but laryer in length. The intermediate and smallest dilator tubes have knurled ends to grasp for removal during steps oE the met11od.
It is one object of the present inventiorl to provide a ~-method for internal fi~ation of the spinal column which is ~-minimally invasive and which poses a minimal health risk to the patient. Another object is to provide such a technique which further permits subcutaneous removal of the temporarily impla11ted hardware in an out-patient procedure.
A further object of the invention is realized by the present technique which contemplates subcutaneous but suprafascial fixation to avoid damage to the spinal musculature and ligaments. Further obJects and certain - advantages of the present invention will become apparent from the following description o the invention.
WO93/18722 PCTtUS92/1033--2 1 0 9 ~ 7 ~ DESCRIPTION ~F THE ~RAW~NGS
, E~IG l. is a section view through the spinal colulnn of a patient shown after ilnplantation of fixation instrume1-tation using the method of the present invention.
FIG. 2 is a side view of a bone screw adapted for use in the method of the present invention.
FIG. 3 is a posterior view of the spinal column of the patient after implantation of fixation instrumentation using the method of the present invention, showing bilateral fixation with linking members across the spinal midline, as viewed beneath the skin but with the muscle tissue removed to expose details of the underlying vertebrae.
FIGS. 4A-C are side views of the components of a three component dilator system for use with the method of the present invention during steps for implanting the bone screw into a vertebra.
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.:
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:;: ' "'~93/1~722 2 1 o 9 o 7 7 PCT/US9~/1033~ ~
~ESCRIPTION OF 'I'HE PREFERREn EM~O~IMEN'r ~:
For the purposes of promoting an ullderstanding of the prirlciples of the inverltioll, reference will IIOW be made to -- the enlbodimellt illustrated ill the ~I-awings and specific lanyuage will be used to describe the same. It will nevertheless be understood tllat no li~nitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications o the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to wh~ch the inven~ion relates.
The present invention first contemplates steps for a percutaneous fusion technique, such as may be used to fuse adjacent vertebrae after disc tissue has been removed.
According to the preferred embodimellt of the invention, the ~
method is cohducted on lumbar vertebrae, although it is ~-believed to be adaptable to other portions of the spine. The ~;patient, after appropriate preparation, is positioned prone 20 on a~ radiolucent padded frame which allows far both AP -(anterior/posterior) and lateral fluoroscopic visualization during the~entire~procedure. A~l initial AP fluoroscopic view ~-is taken with an external guide pin placed parallel to the plane of the end-plates of the affected disc to assure the 25 proper orientation of the procedure relative to the disc -space. A guideline is drawn on the AP radiograph along the guidepin image to demarcate the plane of entry.
In the preferred embodiment of the fusion technique of the pre.ser1t method, a bi-portal approach is utilized to clean out ~the disc nuclear space. Entry points for local anesthesia are located bilaterally from the midlille, nominally about ten centimeters bilaterally from the radiograph guideline (varying between 8 centimeters for a `~
sma~ller patient to 12 centimeters for a larger patient).
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' ,~ .j!,. ' i ; I
W093/18722 PCT/~'S92tlO33-210 9 07 rl After t}le fascia and intrafascia Inusculature are appropriately anesthetized, discography is performed usin~ a ~wo-needle technique bilaterally. Pursuant to the preferred method, the initial needle entry point to the disc anrlulus is located on the mid-pedicle line on the AP radiograph, which is defined ~y the line created by the midportion of the pedicle above and below the disc space being irlstrumented.
Both needles are advanced into the posterior central portion of the nucleus and triangulation is begun. The discography is performed to confirm the nature of the disc disease and the contained verses the uncontained condition of the involved disc structure. (An uncontained disc is a disc which has ruptured through the posterior longitudinal ligament and/or annulus, which therefore allows a free flow of dye from the intranuclear space into the epidural space.) The procedure of the preferred method continues with the introduction of cannulae into the disc space. The hubs of the discogram needles can be removed and then serve as guide wires for the cannulae. Dilating probes are place over the 20 guide wires bilaterally into the annulus of the disc. .
Sheaths are placed over the probes over which progressively larger cannulae can then be advanced to dilate the annulus to an appropriate diameter for intradiscal work. Again, this prior procedure is performed bilaterally at the two entry 25 points described above, and is repeated for each affected disc.
In one aspect of the method, a visualization scope is place through each cannula to verify the annulus an~1 to confirm the anatomy under the cannula. If no nerve tissue is observed and the annular tissue is present, a trephine is introduced after the visualization scope has been removed.
The annulus is perforated and successively sized trephines are used to open an annular hole of adequate dimension for the purpose of disc removal and extra-discal visualization.
Once the trephine operation is complete at each bilateral ~93/18722 PCT/US92/1033~
21 0 .9 0 17 g entry point, two portals are provided. Disc resec~ion can be conducted through one portal w~lile a verifying sco~e can be placed at the other portal. Trian~ula~ioll of the di~c material through one portal is considered achieved when direct visualization of the disc resecting instrument occurs through the viewing portal. The intranuclear cavity of ~he affected disc is completely resected and the superior and inferior end-plates are ablated using cutting and sucking instruments or through the use of laser-assisted ~robes. The instruments may be removed from each portal and transposed for complete resection of the disc nucleus. Rapid disc r' removal instruments for the nucleus and rapid burring de~ices for the end-plates can be used to resect the tissues in preparation for fusion. The instruments may also be used to lS resect the posterior ligamentus structures and the in~erannular ring to create an adequate cavity for introduction of the bone ~raft. Acceptable devices include - burrs, laser, curettes and gauges for the ablation of the .
end-plate tissues to the state of bleeding bone. Both rigid -and flexible scopes can be used for the verification of the complete resection of the intranuclear cavity. Once the disc material has been completely cleared out of the cavity and the end-plates completely ablated, and obturator is placed in each cannula to prevent contamination during this succeeding ~25 portions of the procedure.
At this point Qf the preferred technique of the present invention, bone graft harvesting is undertaken. The bone -~
graft harvesting can be accomplished according to any k~o~rn I techniques suitable for this purpose. In one specific embodimènt of the inventive methocl, after appropriate anes~hesia and analgesia, a small incision is made over either posterior superior iliac crest to expose the outer crest for bone harvesting. The bone is procured from the corticocancellous table and prepared for t11e grafting ~`
process. The bone graft is fashioned to be accommodated WO93/1872~ PCT/US92/1033~
21~)9~)7~ -lO-within the inner dialneter of tl~e largest outer canl1ula employed during the disc resectiorl described above. T}le bor1e may be nlixed with other componen~s, inclu~ing osteoinductive proteins or morphogenic materials. ~rhe bone harvest cite is then irrigated, dried and closed over a small drain.
The next step of the inventive process, t~le instrumentation step, occurs under direct fluoroscopy. Under AP fluoroscopic view, a guide wire (preferably a 0.0~2 guide wire is introduced with tlle sharp end of the guide wire being inserted into the skin at a position slightly offset from the area to be cannulated. In one specific embodiment, the guide wire is introduced one centimeter lateral to the area to be cannulated. The position of the guide pin is verified by fluoroscopy angled to 15 degrees in line with the pedicle.
The guide pin is used to palpate the cortex o~er the pedicle and is then secured by tapping with a mallet to prevent movement of the pin until further advancement is desired.
After the guide pin has been locked into the cortex, tissue dilators are applied to protect the surrounding muscle 20 tissue. The guide pin is then advanced, under lateral -~
fluoroscopic view, into the pedicle and within the vertebral body. The position of the pin is confirmed using both AP and fluoroscopy views. This procedure is repeated for each pedicle o the vertebra. Thus, for eac~l vertebra to be ~25 instrumented, a pair of guide pins are positioned at about a lS angle from the midliIIe and along each pedicle of the vertebra.
After the guide pin insertion process is complete, an incision is made at the guide pin insertion site, which, in 30 one specific embodiment, is about 2.0 cm. in length. Then, ~-using pick-ups and Metzenbaum scissors, subcutaneous tissue is dissected suprafascially. Metzenbawn scissors are also used to dissect the suprafascial subcutaneous tissues rom the ipsilateral pin across the midline to the contralateral guide pin. Dissection o~ this tissue provides space for ~"1)93tl~722 2l09n77 PCI`/US92/1033 connection of pedicle screws ir~ subsequent steps of the method.
~ In t~le llext step of tlle inven~iv~ met~lod, a three c~mponent tissue dilator system is used to dilate t}le tissue 5 at eacll guide pin to accept first a cannulated drill bit and ~hell a larger diameter cannula~ed self-tapping bone screw.
T~le dilator system comprises t~lree tapered tubes of increasing diameter and decreasing length. The tubes are ;
introduced successively from smallest diameter to largest diameter to provide adequate access tbrough the tissue for later steps of the method. After the three component tissue dilator system has been inserted, the smallest of tlle internal dilators is removed allowing for insertion of the drill bit along the guide pin. The bit is used to drill into the initial one-third of the pedicle. The bit is removed and tlle int2rmediate tissue dilator is then removed, leaving the largest dilator still in place. The self-tapping bone screw is inserted through the largest dilator over the guide wire until it is advanced to at least 50% depth of the pedicle.
After~the~position of the bone screw has been confirmed by la~teral fluoroscopy, the guide wire is removed and the screw advanced until the proximal tip of the screw is at the level of the skin incision. This procedure is repeated for each pedicle in each successive vertebra until all the bone screws ~ ... .
~25 are~in place for~the final internal fixation instrumentation.
In-;one specific embodiment, the cannulated drill bit has an~outer~diameter of 4.5 ~n, while the cannulated bone screw can~have a diameter between 5.5-8.5 mm. Thus, in this specificlembodiment, the intermediate dilator of the ~hree : .~
30; c~mponént`dilator systen~ has an internal diameter of at least ; 4.5~mm, and preferably 5.2 ~n to receive the drill bit ~theret~hrough. Likewise, the largest dilator has an internal diameter at least larger than the bone screw, and preferably 9.6~n to acco~nodate a range of bone screw diameters.
Pick-ups are again used to elevate the skin and : : :
WO93/1872~ PCT/US92/1033~
Metzenbaum scissors are used to disse~t any renlaining subcutaneous suprafascial tissue ~s required to accommo~ate rl1sertion of an elonga~ed fixation plate. An appropriately sized fixation plate i5 inserted using forceps through the 2.0 cm. incisions. It is unders~ood tlat the fixation plates are sized to fit over bor1e screws engaged in the pedicles of adjacent vertebrae to provide adequate fixatior1 at each si~e of the spinous process. The fixation plates for tl~e ipsilateral screws are first inserted by forceps and then the procedure is repeated for the contralateral side at each vertebral level requiring instrumentation. In addition, `
linking members are inserted through the incision at the ipsilateral guide pin and passed across the midline in the subcutaneous space to engage the ipsi- and contra- lateral bone screws to accomplish trans-lateral linkage. The linking member can be of the type sold by Danek Medical, Inc., assignee of the present invention, as its CROSSLINKTM
product. Once each of the fixation plates and linking members have been engaged over the appropriate bone screws, a nut is applied in a top-loaded fashion to loosely secure the hardware together. -After each nut is initially threaded onto its corresponding screw, the bone screws are advanced as necessary so that all of the fixation hardware lies ~25 subcutaneously, but suprafascially, at each level of the instrumentation. Once each of the bone screws has reached its ~final resting place within the vertebra, and once all tlle instrumentation, including the fixation plates and linking members, is within the appropriate suprafascial subcutaneous space, the nuts are tightened, while the bone screws are held, at each successive level, thus creating a firm interlock between all of the components oE the fixation system. AP and Iateral fluoroscopic views can document the final position of the hardware to the satisfaction of the operating surgeon.
: ~ .
~"~93/1872' 2 1 0 9 0 7 7 PCT/US92/1033-Once the fixatiorl instru1l1entatio1~ has been inserted, each ~o1le screw insertion cite is th~roug~l]y irriga~ed as well as t~he su~cutaneous space which has accepted the fixa~ion components. The incisions ~re dried and hemostasis verified followed by closure of the incision with subcutaneous absorbable sutures.
With the fixation hardware in place, attention is returned ~o ~he prior portals through which the disc resection was conducted. In this step of the method of the present invention, the obturators are removed from the portals and the previously harvested bone graft material is introduced through one cannula into the disc space. A
visualizing scope is extended through the cannula ir~ the other portal for confirmation of entry of the bone grat into the disc space. A smooth obturator is inserted into the cannula to facilitate advancement of the bone graft material through the cannula into the empty disc nuclear space. After the ipsilateral portal has been completely filled with bone graft material, the same procedure is performed at the contralateral portal. ~isual verification of the grafting procedure in the contralateral portal is not possible because the first portal has been filled by graft material. However, fluoroscopy can be used to identify the introduction of the obturator into the disc nuclear cavity, thereby confirming ~25 the location of the bone graft material. Upon completion of the grafting process, the cannulae are removed, the subcutaneous tissue irrigated and t11e discography entry points are closed with absorbable sutures.
With'the foregoing description of the inventive method in ....
3a mind, attention is directed to tle figures. In FIG. l, a cross-sectional view of a vertebral region of a patient Sl10WS
a vertebra l0 having pedicle portions ll. In this superior section view, a disc is shown with its arlnulus 15 intact but with an empty nuclear space 16 after the disc tissue has been resected. Fixation hardware is shown at only one side of the WO93/187'2 PCT/US92/1033``
21~9077 -14-midline ML defined ~y the spillous process of ~lle vertebra ~.
lO. However, as depicted in FIG. 3, fixation instrumenta~ion ls implanted on either side of t~1e nlidline ML. FIG. 3 ~urt11er shows ~ixation between adjacent verte~rae, identified as vertebra lO and lO', with corresponding body portions lOa, transverse processes lOb and lOc, spinous processes lOd, and laminae lOe.
The entry sites 25a and 25b shown in FIG. l are used in the disc resection steps of the method. FIGS. l and 3 show the location of the portals 26a and 26b through which~the disc annulus is removed and the bone graft material ~-introduced. As described above, the entry sites 25a and 25b :-are nominally lO.0 cm bilaterally from the midline ML. The portals 26a and 26b are oriented so that the disc resection tools can be inserted below the transverse processes lOc of the vertebra at the level of the nerve root.
Referring again to FIG. l, the skin 20 of the patient is shown dissected from the fascia 22 protecting muscle tissue 23 to provide a suprafascial subcutaneous space 25. An incision 27 is shown through which the fixation hardware is inserted in accordance with the method described above. The fixation hardware includes a bone screw 30, which is preferably a pedicle screw. A fixation plate 40 is mounted on the screw 30, held in place by a nut 42. In the posterior -~25 view of FIG. 3, ~the fixation hardware is also shown as including linking members 44 spanning across the midline ~between corresponding bone screws 30.
As~can be seen most clearly in FIG. l, the method of the present i~lvention provides a technique for instlumentir1g adjacent vertebra to facilitate fusion. Implantation of the fixation instrumentation according to the inventive method ~; causes minimal invasion to the patien~, with the insertion occurring throuyh a single incision, like incision 27, -;
~; aligned with each pedicle. Most significantly, the hardware resides within the suprafascial subcutaneous space 25 so that ~ .
93/18722 ~ Q 7 7 PCT/US92/1033 destruction of muscle tissue is not required. With ~his method, patient mor~idity rates are reduces, while healir~
r~ates are improved. Since the fixation hardware resides above the muscle layer, removal can be conducted in an out-~atient procedure under a local anesthetic.
Referring now to FIG. 2, the details of a bone screw ,,, particularly adapted for t~le present met~lod is shown. The screw 30 includes a distal threaded shank 31, which in the preferred embodiment is configured as a self-tapping pedicle screw in accordance with known technology. The proximal end of the screw 30 includes a machine threaded stem 34, which is ', threaded for engagement with the nut 42 used to fix the fixation plate 4U and linking member 44. The stem 34 terminates in a driving hex recess 35 which is engaged by an ;~, appropriate screw driving tool as known in the art.
(Alternatively, a hex projection can be used in lieu of the recess 35, with an appropriate change in the screw driving tool.) Intermediate the distal shank 31 and proximal stem 34 is a smooth shank portion 32. The smooth shank portion 32 defines a hub 33 near the proximal threaded stem 34. The hub 33 includes a surface 33a configured to support the fixation plate 40. When the nut 42 is tightened onto the proximal stem 34, the fixation plate 40 is locked between the nut and ~25 the hub surface 33a. The hub 33 supports the fixation plate to keep it within the suprafascial space ,25. The surface 33a is preferably slightly curved to fit within a scalloped fixation plate of known design in the art. The screw 30 is cannulated along its entire length, as represented by the bore 36 provided for guidewire insertion.
The smooth shank portion 32 provides a non-irritating surface for contacting the fascia and muscle tissue. The length of the smooth shank portion 32 is determined by the muscle thickness around the instrumented vertebra, and is generally equal in length to the length of the bone engaging W093/I8722 PCT/US9~/1033 thLeaded2 ~0 ~~1~. In orle spe~ific elllbodilllent, the screw 30 has a length measured from the tip of the bone engaging shank 31 ~o the underside of the mounting hu~ 33 of 65-75 mln. The bone engaging distal shank 31 has a nonlinal lengtll of 35 mm which provides optimum engagement with the vertebra. The smooth shank portion 32 accounts for the remainder of ~he 65-75 n~l length~ or between 30-40 mm. The ma~hine threade~
stem 34 has a length, as measured from surface 33a of the mounting hub 33, that is sufficient to acc~Imnodate the fixation plate 40, a nut 42 and a linking member 44. In the specific embodiment, the length of the machine threaded stem 34 is 10-15 ~n so that very little of the stem projects beyond the nut. The bone screw 30 can have a diameter of between 5.5-8.5 mm as required for the patient and fixation ;
procedure. It is understood, of course, that the specific dimensions are illustrative of a nominal bone screw ;-configuration. These dimensions can be varied as required ~-~
for a particular patient or procedure, while still adhering to the basic concept~ of the present illven~ion.
Referriny now to FIGS. 4A-C, the components of a three component dilator system 50 are shown. As described above, the dilator system is used to acilate implantation of the bone screw 30 into the vertebrae of the patient. The system 50 includes three successively smaller and longer dilator ~25 tubes 51, 56 and 61. Each dilator tube is tapered at its respective tip 53, 58 and 63 for atraumatic introduction of the tubes through the skin and tissue of the patient. Each of the tubes is cannulated or hollow as represented by ~-respective bores 52, 57 and 62 therethrough. The bore 52 in the thinnest dilator tube 51 has a diameter sufficient to accept a guidewire therethrough. The bore 57 in the intermediate dialneter dilator tube 56 has a diameter slightly larger than the outer diameter of the dilator tube 51.
Likewise, the bore 62 in the largest diameter dilator tube 61 is slightly larger than the outer diameter of tbe dilator tube 56.
~93/1872~ 21 0 9 o 7 7 PCT/~S92t1033 T~le ends of the slnallest and intermediate diameter tubes~;
51 and 56, ends 54 and 59 respectively, are knurled to provide a gripping surface for removal of ~he tubes. lile lengths of the tubes are graduated so that the smallest diameter tube 51 has the greatest length, while the intelmediate tube 56 has is longer than the outermost laryer diameter dilator tube 61. This length differential also facilitates sequential removal of the tubes 51 and 56, just prior to and just after the vertebra has been drilled in the lO instrumentation step of the method. ~-In one specific embodiment of the three component dilator system 50 of the present invention, the smallest diameter dilator tube 51 has an outer diameter of about 5 mm, a length of 152.5 mm, and a cannulated bore diameter of about 2 ~n.
~he intermediate dilator tube 56 has an outer diameter of 9.4 mm, a length of about 140.0 mm, and a cannulated bore diameter of 5.15 mm (leaving 0.15 mm clearance for insertion of the tube 51). The final dîlator tube 61, through which the bone screw 30 is inserted, has an outer diameter of 11.1 mm, a length of 127.0 mm and a cannulated bore diameter of 9.58 mm to receive the intermediate dilator tube 56, as well as the bone screw 30, therethrough.
While the invention has been illustrated and described in detail in the drawings and foreyoing description, the same is 25 to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the inventioh are desired to be protected.
: ~ :
Claims (19)
1. A method for internal fixation of the spine comprising the steps of:
a) inserting a guide pin into a pedicle of at least two vertebrae to be instrumented for internal fixation;
b) making an incision in the skin at the entry site of each guide pin;
c) dissecting subcutaneous suprafascial tissue between each entry site;
d) initially advancing a bone engaging fastener over each guide pin through each incision and into each pedicle, the fastener having bone engaging threads and machine threads for engaging a nut;
e) elevating the skin between each entry site;
f) inserting an elongated fixation element into the subcutaneous suprafascial space and supporting the element on and between at least two bone engaging fasteners adjacent the machine threaded portion of the fasteners; and g) clamping the fixation element to the bone fasteners using nuts engaging the machine threaded portions of the bone screws with the fixation element supported above the fascia and muscle tissue but beneath the skin of the patient.
a) inserting a guide pin into a pedicle of at least two vertebrae to be instrumented for internal fixation;
b) making an incision in the skin at the entry site of each guide pin;
c) dissecting subcutaneous suprafascial tissue between each entry site;
d) initially advancing a bone engaging fastener over each guide pin through each incision and into each pedicle, the fastener having bone engaging threads and machine threads for engaging a nut;
e) elevating the skin between each entry site;
f) inserting an elongated fixation element into the subcutaneous suprafascial space and supporting the element on and between at least two bone engaging fasteners adjacent the machine threaded portion of the fasteners; and g) clamping the fixation element to the bone fasteners using nuts engaging the machine threaded portions of the bone screws with the fixation element supported above the fascia and muscle tissue but beneath the skin of the patient.
2. The method for internal fixation of the spine of claim 1, further comprising the following steps between the fixation element insertion and clamping steps:
loosely engaging a nut on the nut threaded portion of each of the bone fasteners; and further advancing each bone fastener deeper into the respective pedicle until the fixation element lies immediately adjacent the fascia.
loosely engaging a nut on the nut threaded portion of each of the bone fasteners; and further advancing each bone fastener deeper into the respective pedicle until the fixation element lies immediately adjacent the fascia.
3. The method for internal fixation of the spine of claim 1, wherein:
each of the steps (a)-(g) is repeated on opposite sides of the spinous process for bilateral instrumentation of each pedicle of each vertebrae.
each of the steps (a)-(g) is repeated on opposite sides of the spinous process for bilateral instrumentation of each pedicle of each vertebrae.
4. The method for internal fixation of the spine of claim 3, further comprising the steps of:
dissecting subcutaneous suprafascial tissue between the ipsilateral and contralateral bone fasteners at each level of instrumentation of the vertebrae; and after the step of inserting the fixation element, inserting a linking member between bilateral bone fasteners at the same level of instrumentation with the machine threaded portion of the bone fasteners projecting above the linking member.
dissecting subcutaneous suprafascial tissue between the ipsilateral and contralateral bone fasteners at each level of instrumentation of the vertebrae; and after the step of inserting the fixation element, inserting a linking member between bilateral bone fasteners at the same level of instrumentation with the machine threaded portion of the bone fasteners projecting above the linking member.
5. The method for internal fixation of the spine of claim 1, wherein the step of advancing the bone fastener includes the steps of:
advancing a cannulated drill bit over each guide pin; and using the drill bit, drilling into the pedicle to a predetermined depth less than the length of the bone engaging threads of the bone fastener.
advancing a cannulated drill bit over each guide pin; and using the drill bit, drilling into the pedicle to a predetermined depth less than the length of the bone engaging threads of the bone fastener.
6. The method for internal fixation of the spine of claim 5, wherein:
in the drilling step the predetermined depth is about one-third of the pedicle depth; and in the step of initially advancing the bone fastener, the bone fastener is advanced into at least one-half of the pedicle depth.
in the drilling step the predetermined depth is about one-third of the pedicle depth; and in the step of initially advancing the bone fastener, the bone fastener is advanced into at least one-half of the pedicle depth.
7. The method for internal fixation of the spine of claim 1, wherein the step of advancing the bone fastener includes the steps of:
dilating the tissue at each entry site using three dilators having successively larger diameters;
removing the smallest dilator;
advancing a cannulated drill bit over each guide pin through an intermediate dilator; and using the drill bit, drilling into the pedicle to a predetermined depth less than the length of the bone engaging threads of the bone fastener.
dilating the tissue at each entry site using three dilators having successively larger diameters;
removing the smallest dilator;
advancing a cannulated drill bit over each guide pin through an intermediate dilator; and using the drill bit, drilling into the pedicle to a predetermined depth less than the length of the bone engaging threads of the bone fastener.
8. The method for internal fixation of the spine of claim 7, wherein the step of advancing the bone fastener further includes the subsequent steps of:
removing the intermediate dilator, leaving the largest diameter dilator; and advancing the bone fastener over the guide pin and through the largest dilator.
removing the intermediate dilator, leaving the largest diameter dilator; and advancing the bone fastener over the guide pin and through the largest dilator.
9. A method for percutaneously resecting the nucleus of a spinal disc, comprising the steps of:
a) introducing a pair of cannulae bilaterally into the disc space of the affected disc;
b) perforating the disc annulus at each cannula insertion site;
c) inserting a cutting instrument into one cannula and a viewing instrument into the other cannula;
d) resecting the disc nuclear material through the one cannula under direct vision through the other cannula;
e) transposing the cutting instrument and viewing instrument between cannulae and resecting the remaining disc nuclear material through the other cannula.
a) introducing a pair of cannulae bilaterally into the disc space of the affected disc;
b) perforating the disc annulus at each cannula insertion site;
c) inserting a cutting instrument into one cannula and a viewing instrument into the other cannula;
d) resecting the disc nuclear material through the one cannula under direct vision through the other cannula;
e) transposing the cutting instrument and viewing instrument between cannulae and resecting the remaining disc nuclear material through the other cannula.
10. The method for percutaneously resecting the nucleus of a spinal disc of claim 9, wherein, in the step of introducing the pair of cannulae the entry points for the cannulae are nominally ten centimeters bilaterally from the midline of the spinous process and the cannulae are introduced below the transverse processes of the adjacent vertebra.
11. The method for percutaneously resecting the nucleus of a spinal disc of claim 9, further comprising the step of verifying the anatomy under each cannulae using a visualization scope prior to perforating the disc annulus.
12. The method for percutaneously resecting the nucleus of a spinal disc of claim 9, wherein the step of resecting the disc material includes terminating resection through the one cannula when the cutting instrument can be seen under direct vision through the other cannula.
13. The method for percutaneously resecting the nucleus of a spinal disc of claim 9, wherein the step of resecting the disc material includes ablating the disc end plates using an ablating instrument introduced through the cannula.
14. A method for introducing bone graft material into an intervertebral disc space comprising the steps of:
a) creating bilateral cannulated portals into an affected disc;
b) removing the nucleus of the disc;
c) inserting a viewing instrument into the first portal;
d) introducing bone graft material into the second portal;
e) advancing the graft material through the second portal into the empty disc space; and f) verifying the entry of the graft material through the viewing instrument in the first portal.
a) creating bilateral cannulated portals into an affected disc;
b) removing the nucleus of the disc;
c) inserting a viewing instrument into the first portal;
d) introducing bone graft material into the second portal;
e) advancing the graft material through the second portal into the empty disc space; and f) verifying the entry of the graft material through the viewing instrument in the first portal.
15. The method for introducing bone graft material into an intervertebral disc space of claim 14, wherein the step of advancing the graft material includes using an obturator to push the material through the portal into the empty disc space.
16. The method for introducing bone graft material into an intervertebral disc space of claim 14, comprising the additional subsequent steps of:
g) removing the viewing instrument from the first portal; and h) advancing graft material through the first portal into the disc space.
g) removing the viewing instrument from the first portal; and h) advancing graft material through the first portal into the disc space.
17. A bone engaging fastener for internal fixation of the spine, comprising:
a distal threaded shank having threads for engagement within a vertebra;
a proximal threaded stem having machine threads for engagement with a threaded nut; and a smooth shank intermediate said threaded shank and said threaded stem, said smooth shank having a hub near said threaded stem, said hub defining a support surface for supporting an elongated fixation element attached to the bone engaging fastener over said proximal stem, wherein said smooth shank has a length from said threaded shank to said hub that is approximately equal to distance from the pedicle to the the muscle fascia of a patient, so that said hub is situated above the muscle fascia when said distal threaded shank is engaged in a vertebra of the patient.
a distal threaded shank having threads for engagement within a vertebra;
a proximal threaded stem having machine threads for engagement with a threaded nut; and a smooth shank intermediate said threaded shank and said threaded stem, said smooth shank having a hub near said threaded stem, said hub defining a support surface for supporting an elongated fixation element attached to the bone engaging fastener over said proximal stem, wherein said smooth shank has a length from said threaded shank to said hub that is approximately equal to distance from the pedicle to the the muscle fascia of a patient, so that said hub is situated above the muscle fascia when said distal threaded shank is engaged in a vertebra of the patient.
18. A three component dilator system for use in implantation of a bone screw into a vertebra, comprising:
a first tubular dilator having a tapered end, a first length and a first diameter;
a second tubular dilator having a tapered end, a second length and a second diameter;
a third tubular dilator having a tapered end, a third length and a third diameter;
wherein said first diameter is greater than said second diameter which is greater than said third diameter, and wherein said first length is shorter than said second length which is shorter than said third length.
a first tubular dilator having a tapered end, a first length and a first diameter;
a second tubular dilator having a tapered end, a second length and a second diameter;
a third tubular dilator having a tapered end, a third length and a third diameter;
wherein said first diameter is greater than said second diameter which is greater than said third diameter, and wherein said first length is shorter than said second length which is shorter than said third length.
19. The three component dilator system of claim 18, wherein:
said second tubular dilator has a second end opposite said tapered end, said second dilator having a knurled outer surface adjacent said second end; and said third tubular dilator has a second end opposite said tapered end, said third dilator having a knurled outer surface adjacent said second end.
said second tubular dilator has a second end opposite said tapered end, said second dilator having a knurled outer surface adjacent said second end; and said third tubular dilator has a second end opposite said tapered end, said third dilator having a knurled outer surface adjacent said second end.
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US07/852,577 US5171279A (en) | 1992-03-17 | 1992-03-17 | Method for subcutaneous suprafascial pedicular internal fixation |
US852,577 | 1992-03-17 |
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CA2109077A1 true CA2109077A1 (en) | 1993-09-18 |
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CA002109077A Abandoned CA2109077A1 (en) | 1992-03-17 | 1992-12-01 | Method for subcutaneous suprafascial pedicular internal fixation |
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JP (1) | JPH06507820A (en) |
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1993
- 1993-01-01 CN CN93100047A patent/CN1076851A/en active Pending
- 1993-01-04 US US08/000,391 patent/US5357983A/en not_active Expired - Lifetime
- 1993-10-10 EP EP93900738A patent/EP0584293A1/en not_active Withdrawn
- 1993-11-16 NO NO934137A patent/NO934137D0/en unknown
- 1993-11-16 FI FI935062A patent/FI935062A/en not_active Application Discontinuation
-
1994
- 1994-07-22 US US08/279,222 patent/US5496322A/en not_active Expired - Lifetime
-
1995
- 1995-05-09 US US08/437,523 patent/US5569248A/en not_active Expired - Lifetime
-
1996
- 1996-01-18 AU AU42083/96A patent/AU681816B2/en not_active Ceased
- 1996-07-09 US US08/677,135 patent/US5728097A/en not_active Expired - Lifetime
-
1998
- 1998-03-17 US US09/042,910 patent/US6033406A/en not_active Expired - Fee Related
-
2000
- 2000-03-06 US US09/519,295 patent/US6793656B1/en not_active Expired - Fee Related
-
2004
- 2004-09-02 US US10/933,155 patent/US20050038434A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
US5496322A (en) | 1996-03-05 |
NO934137L (en) | 1993-11-16 |
FI935062A0 (en) | 1993-11-16 |
AU666908B2 (en) | 1996-02-29 |
US5171279A (en) | 1992-12-15 |
US6793656B1 (en) | 2004-09-21 |
US20050038434A1 (en) | 2005-02-17 |
JPH06507820A (en) | 1994-09-08 |
AU3231693A (en) | 1993-10-21 |
AU4208396A (en) | 1996-04-04 |
ZA929693B (en) | 1993-06-09 |
US5569248A (en) | 1996-10-29 |
NO934137D0 (en) | 1993-11-16 |
NZ246236A (en) | 1997-11-24 |
BR9206001A (en) | 1994-10-11 |
US5728097A (en) | 1998-03-17 |
FI935062A (en) | 1993-11-16 |
AU681816B2 (en) | 1997-09-04 |
US5357983A (en) | 1994-10-25 |
WO1993018722A1 (en) | 1993-09-30 |
EP0584293A1 (en) | 1994-03-02 |
MX9206758A (en) | 1993-09-01 |
CN1076851A (en) | 1993-10-06 |
EP0584293A4 (en) | 1994-08-31 |
US6033406A (en) | 2000-03-07 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
FZDE | Discontinued |