CA2581882A1 - Connector transfer tool for internal structure stabilization systems - Google Patents
Connector transfer tool for internal structure stabilization systems Download PDFInfo
- Publication number
- CA2581882A1 CA2581882A1 CA002581882A CA2581882A CA2581882A1 CA 2581882 A1 CA2581882 A1 CA 2581882A1 CA 002581882 A CA002581882 A CA 002581882A CA 2581882 A CA2581882 A CA 2581882A CA 2581882 A1 CA2581882 A1 CA 2581882A1
- Authority
- CA
- Canada
- Prior art keywords
- connector
- rod
- tine
- recess
- distal end
- 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
- 230000006641 stabilisation Effects 0.000 title abstract description 21
- 238000011105 stabilization Methods 0.000 title abstract description 21
- 238000012546 transfer Methods 0.000 title description 35
- 230000007246 mechanism Effects 0.000 claims abstract description 24
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 19
- 230000008878 coupling Effects 0.000 claims description 6
- 238000010168 coupling process Methods 0.000 claims description 6
- 238000005859 coupling reaction Methods 0.000 claims description 6
- 239000007943 implant Substances 0.000 claims description 4
- OCDRLZFZBHZTKQ-NMUBGGKPSA-N onetine Chemical compound C[C@@H](O)[C@@]1(O)C[C@@H](C)[C@@](C)(O)C(=O)OC\C2=C\CN(C)CC[C@@H](OC1=O)C2=O OCDRLZFZBHZTKQ-NMUBGGKPSA-N 0.000 claims description 3
- 238000000034 method Methods 0.000 description 18
- 210000005036 nerve Anatomy 0.000 description 9
- 230000000712 assembly Effects 0.000 description 8
- 238000000429 assembly Methods 0.000 description 8
- 238000007470 bone biopsy Methods 0.000 description 7
- 230000008569 process Effects 0.000 description 5
- 238000005259 measurement Methods 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 3
- 230000013011 mating Effects 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 230000007704 transition Effects 0.000 description 3
- 230000004927 fusion Effects 0.000 description 2
- 230000000087 stabilizing effect Effects 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 238000013519 translation Methods 0.000 description 2
- 230000004075 alteration Effects 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 210000005069 ears Anatomy 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 210000003041 ligament Anatomy 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 210000000278 spinal cord Anatomy 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
Classifications
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- 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
- A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
- A61B17/7038—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other to a different extent in different directions, e.g. within one plane only
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- A61B17/1604—Chisels; Rongeurs; Punches; Stamps
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- A61B17/1655—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for tapping
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- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
- A61B17/1757—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the spine
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- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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- 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
- A61B17/7005—Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit in the screw or hook heads
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- 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
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- A61B17/701—Longitudinal elements with a non-circular, e.g. rectangular, cross-section
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
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- A61B17/7011—Longitudinal element being non-straight, e.g. curved, angled or branched
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- 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
- A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
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- 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
- A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
- A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- 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
- A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
- A61B17/704—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other the longitudinal element passing through a ball-joint in the screw head
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- 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
- A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
- A61B17/7076—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
- A61B17/7082—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws
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- 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
- A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
- A61B17/7083—Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
- A61B17/7085—Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements for insertion of a longitudinal element down one or more hollow screw or hook extensions, i.e. at least a part of the element within an extension has a component of movement parallel to the extension's axis
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- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
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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
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
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- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
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- A61B90/06—Measuring instruments not otherwise provided for
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- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
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Abstract
A tool (5700) is described for use in a stabilization system for bony structures such as vertebrae, where the system involves connecting a connector from one bone anchor in a vertebra to a second bone anchor in another vertebra. The tool includes a handle attached to an arm. The arm is connected by a pivot (5708) to a connector engagement mechanism, the pivot allowing the connector engagement mechanism to move from an orientation inline with the arm to an orientation at an angle relative to the arm by rotating at the pivot.
The connector engagement mechanism is engaged to an end of the connector when the tool is in its inline orientation and by causing the movement, which can be by the movement of a lever (5703) on the handle, of the connector engagement mechanism to the angled orientation, the end of the connector is moved into a position for engagement with the second bone anchor.
The connector engagement mechanism is engaged to an end of the connector when the tool is in its inline orientation and by causing the movement, which can be by the movement of a lever (5703) on the handle, of the connector engagement mechanism to the angled orientation, the end of the connector is moved into a position for engagement with the second bone anchor.
Description
CONNECTOR TRANSFER TOOL FOR INTERNAL STRUCTURE
STABILIZATION SYSTEMS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to: U.S. Provisional Application No.
60/617,461 filed on October 8, 2004, entitled "MEDICAL DEVICES AND METHODS
FOR USE IN A MINIMALLY INVASIVE SPINAL FIXATION SYSTEM;" and U.S.
Utility Application No. 10/989,782 filed on November 16, 2004, entitled "CONNECTOR TRANSFER TOOL FOR INTERNAL STRUCTURE
STABILIZATION SYSTEMS;" and U.S. Utility Application No. 10/990,221 filed on November 16, 2004, entitled "INTERNAL STRUCTURE STABILIZATION SYSTEM
FOR SPANNING THREE OR MORE STRUCTURES;" and U.S. Utility Application No. 10/990,272 filed on November 16, 2004, entitled "AN IMPLANT ASSEMBLY
AND METHOD OF USE IN AN INTERNAL STRUCTURE STABILIZATION
SYSTEM;" the disclosures of which are hereby incorporated herein by reference.
CONNECTOR TRANSFER TOOL FOR INTERNAL STRUCTURE
STABILIZATION SYSTEMS
TECHNICAL FIELD
STABILIZATION SYSTEMS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to: U.S. Provisional Application No.
60/617,461 filed on October 8, 2004, entitled "MEDICAL DEVICES AND METHODS
FOR USE IN A MINIMALLY INVASIVE SPINAL FIXATION SYSTEM;" and U.S.
Utility Application No. 10/989,782 filed on November 16, 2004, entitled "CONNECTOR TRANSFER TOOL FOR INTERNAL STRUCTURE
STABILIZATION SYSTEMS;" and U.S. Utility Application No. 10/990,221 filed on November 16, 2004, entitled "INTERNAL STRUCTURE STABILIZATION SYSTEM
FOR SPANNING THREE OR MORE STRUCTURES;" and U.S. Utility Application No. 10/990,272 filed on November 16, 2004, entitled "AN IMPLANT ASSEMBLY
AND METHOD OF USE IN AN INTERNAL STRUCTURE STABILIZATION
SYSTEM;" the disclosures of which are hereby incorporated herein by reference.
CONNECTOR TRANSFER TOOL FOR INTERNAL STRUCTURE
STABILIZATION SYSTEMS
TECHNICAL FIELD
[0002] This invention relates to bone stabilization systems, and more particularly to tools for percutaneously rotating a connector to span two pedicle screw stabilization anchors.
BACKGROUND OF THE INVENTION
BACKGROUND OF THE INVENTION
[0003] The human spine provides a vast array of functions, many of which are mechanical in nature. The spine is constructed to allow nerves from the brain to pass to various portions of the middle and lower body. These nerves, typically called the spinal cord, are located in a region within the spine called the spinal canal.
Various nerve bundles emerge from the spine at different locations along the lateral length of the spine.
In a healthy spine, these nerves are protected from damage and/or undue pressure thereon by the structure of the spine itself.
Various nerve bundles emerge from the spine at different locations along the lateral length of the spine.
In a healthy spine, these nerves are protected from damage and/or undue pressure thereon by the structure of the spine itself.
[0004] The spine has a complex curvature made up of a plurality (24 in all) of individual vertebrae separated by intervertebral discs. These discs hold the vertebrae together in a flexible manner so as to allow a relative movement between the vertebrae from front to back and from side to side. This movement then allows the body to bend forward and backward, to twist from side to side, and to rotate about a vertical axis.
Throughout this movement, when the spine is operating properly the nerves are maintained clear of the hard structure of the spine.
[00051 Over time, or because of accidents, the intervertebral discs loose height, become cracked, dehydrated, or herniated. The result is that the disc height is reduced leading to compression of the nerve bundles, causing pain and in some cases damage to the nerves.
[0006] Currently, there are many systems and methods at the disposal of a physician for reducing, or eliminating, the pain by minimizing the stress on the nerve bundles. In some instances, the existing disk is removed and an artificial disk is substituted therefore. In other instances, two or more vertebrae are fused together to prevent relative movement between the fused discs.
[0007] Often there is required a system and method for maintaining, or recreating, proper space for the nerve bundles that emerge from the spine at a certain location. In some cases a cage or bone graft is placed in the disc space to preserve, or restore, height and to cause fusion of the vertebral level. As an aid in stabilizing the vertebrae, one or more rods or braces are placed between the fused vertebrae with the purpose of the rods being to support the vertebrae, usually along the posterior of the 25584719.1 3 spine while fusion takes place. These rods are often held in place by anchors which are fitted into the pedicle of the vertebrae. One type of anchor is a pedicle screw, and such screws come in a variety of lengths, diameters, and thread types.
[0008] One problem occurs attempting to position a rod to span between anchors positioned in bones such as vertebrae. Once solution to the problem of positioning a rod is described in U.S. Application Serial Number 10/690,211 filed October 21, 2003 entitled SYSTEM AND METHOD FOR STABILIZING INTERNAL
STRUCTURES, which is hereby incorporated by reference, and shows a rod pre-attached to a first anchor by means of a hinge, such that the proximal end of the rod may be rotated toward a second anchor. The proximal end of the rod may be captured by a capturing hinge attached to the second anchor, the capturing hinge including a mechanism for locking the proximal end of the rod in place. What is needed is a tool operable to rotate the proximal end of the rod toward the second anchor and into the capturing hinge.
BRIEF SUMMARY OF THE INVENTION
[0009] The present invention describes various embodiments of tools for use in spinal stabilization procedures. The tool is used to transfer a rod or other stabilization device in an assembly from a first bone anchor assembly to a second bone anchor assembly inserted into a first and second bony structure, such as the pedicle of a vertebra.
[0010] A medical instrument characterized by: an elongated body having a proximal and distal end; a handle coupled to the proximal end; wherein the distal end includes: a means for pivotally coupling to a bone anchor connector such that the connector can rotate about its distal end from a first angular position to a second angular position, and a means for locking and unlocking the distal end to the connector, wherein when the connector is in the first angular position the connector may be locked to the distal end and when the connector is in the second angular position, the connector may be unlocked to the distal end.
[0011] The medical instrument may be further characterized in that the means for pivotally coupling further comprises: an enlarged end having a pocket for partially enclosing a portion of the connector, and at least one tine for rotatingly engaging a recess in the connector, wherein the tine is positioned within the pocket.
Furthermore, the means for locking and unlocking may further comprise at least one elongated tine sized to be restrained by an opening in the connector when the tine is in one angular position relative to the connector and to be able to pass through the opening when the tine is in a second angular position relative to the connector.
[0012] The medical instrument may also be further characterized in that the means for locking and unlocking further comprises the second portion having a cam for causing the connector to disengage from the said connector engagement mechanism as said second arm reaches said second orientation.
[0013] There may also be a means for biasing the tine such that the tine stays in the recess when the tine is in the first angular position.
[00141 The medical instrument may be further characterized in that the elongated body further comprises an in-line portion for positioning within a first extension, an in-line portion having at least one hinge for allowing a second portion of the distal end to move from the in-line position to a flexed position.
[0015] There may also be an articulating means for controlling the movement of the second portion coupled to the proximal end.
[0016] The medical instrument may even further be characterized by a means for providing a tactile or audible feedback indication when the connector is locked to the distal end.
[0017] There may also be implant system characterized by: a medical instrument characterized by: an elongated body having a proximal and distal end; a handle coupled to the proximal end; wherein the distal end includes: a means for pivotally coupling to a bone anchor connector such that the connector can rotate about its distal end from a first angular position to a second angular position, and a means for locking and unlocking the distal end to the connector, wherein when the connector is in the first angular position the connector may be locked to the distal end and when the connector is in the second angular position, the connector may be unlocked to the distal end; wherein the medical instrument may be further characterized in that the means for pivotally coupling further comprises: an enlarged end having a pocket for partially enclosing a portion of the connector, and at least one tine for rotatingly engaging a recess in the connector, wherein the tine is positioned within the pocket; a rod-like connector, wherein the proximal end of the rod-like connector includes: at least one recess; a first channel leading to the recess for allowing the tine to following the channel then to drop into the recess; a second channel leading from the recess for allowing the tine to escape from the recess when the channel is in an unique orientation relative to the tine.
[0018] There maybe a connector for connecting at least two bone anchors, the connector characterized by: an elongated body having a proximal and distal end;
wherein the proximal end includes: two recesses on opposing sides of the distal end; a pair of channels leading to the recess for allowing a tine of a medical instrument to following a channel then to drop into the recess; a second pair of channels leading the recess for allowing the tine to escape from the recess when the channel is in an unique orientation relative to the tine.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which:
[0020] FIGURE 1 is a perspective view of an embodiment of an internal stabilization system in accordance with the present invention;
[0021] FIGURE 2 is a perspective view of the rod and anchor assembly of FIGURE 10A mounted with the head of FIGURE 3;
[0022] FIGURE 3 is a perspective view of the rod, anchor and head assembly of FIGURE 11 where the drive mechanism of the rod has been disengaged from the anchor and rotated within the head;
[0023] FIGURE 4 is a perspective view of a rod transfer tool in accordance with the present invention;
[0024] FIGIJRE 5 is a perspective view of the rod transfer tool of FIGURE
4 with the distal arm bent upward;
[0025] FIGURE 6 shows is a perspective view of the distal arm end of the rod transfer tool of FIGURE 47;
[0026] FIGURE 7 is a side view of the tip of the distal arm of the rod transfer tool of FIGURE 4.
[0027] FIGURE 8 is a side view of the rod transfer tool of FIGURE 57 in operation with the assemblies of FIGURE 2;
[0028] FIGURE 9 is a section view taken through lines 62-62 of FIGURE
8;
[0029] FIGURE 10 is a cut-away view illustrating the orientation of a tine of the rod transfer tool of FIGURE 4 with the distal end of the rod of FIGURE
2;
[0030] FIGURE 11 is a side view the rod transfer tool of FIGURE 4 operating to transfer a rod from the assembly of FIGURE 2 into the capturing head of the assembly of FIGURE 1;
[0031] FIGURE 12 shows a cross-section through section 65a-65a of FIGURE 11;
[0032] FIGURE 13 shows a cross-section through 65b-65b of FIGURE 12;
[0033] FIGURE 14 is a side view of a multi-pedicle assembly with a tool shown rotating the rod into position;
[0034] FIGURE 15 is a side view of a three pedicle assembly according to the present invention;
DETAILED DESCRIPTION OF THE INVENTION
[0035] To better understand the devices, assemblies, tools, and methods described below, and understanding of the procedure through which the back stabilization of the present invention is placed into the vertebrae of a patient is required.
Reference is made to the figure numbers where specific embodiments of the tools are described in greater detail to aid in the understanding of those particular items.
[0036] An operation to insert a pedicle screw assembly into a patient's back to immobilize certain vertebrae in order to allow bone grafts to ultimately fuse those vertebrae begins with the surgeon inserting a standard bone biopsy needle into the pedicle of a first vertebra and using the bone biopsy needle to place a guide wire where the first pedicle screw should be inserted. Using the guide wire, progressively larger tissue expanders are inserted into the patient to expand, or dilate, the incision to the size necessary to accommodate the instruments to be used, with the fmal cannula being left in the incision after the smaller ones are removed. Next, an awl is used to enlarge the hole in the pedicle made by the bone biopsy needle with the awl being inserted over the guide wire to ensure proper placement in the pedicle. A tap, having a diameter slightly smaller than the pedicle screw to be used, is inserted down the guide wire and used to tap the hole started by the bone biopsy needle and the awl, making it ready to accept the first pedicle screw.
[0037] A first pedicle screw with a poly-axial rod-capturing head attached to form a rod-capturing pedicle screw assembly is inserted down the guide wire using the off-axis screw guide of the pedicle screw and into the hole left by the tap.
Attached to this pedicle screw assembly are an extension and drive mechanism with a torque head attachment. The extension allows access to the pedicle screw assembly once it is in place. The drive mechanism is used to screw the pedicle screw assembly in place and is removed from the extension once the pedicle screw assembly is set to the desired depth.
[0038] A tissue separator is used to make a path from the first and second, and potentially additional, vertebra where the second pedicle screw assembly will be inserted. As described above a bone biopsy needle is used to insert a guide wire into the second vertebra where the second pedicle screw assembly is to be placed. Once the guide wire is in place a measurement tool is used measure the distance between the first 25584719.1 10 pedicle screw assembly and the guide wire, the measurement determining the length of the rod to be used. The second pedicle screw assembly is then chosen according to the proper length of the rod. The second pedicle screw assembly is formed by a pedicle screw identical to the pedicle screw of the first assembly, a poly-axial rod-assembly head, a slide ring, and a rod all connected to another extension. A drive mechanism with a head to accept the end of the rod is used to drive the second pedicle screw assembly into the pedicle of the second vertebra, using the rod to transfer torque fiom the drive mechanism to the pedicle screw. As before the pedicle screw is sent along the guide wire using the off-axis screw guide in the pedicle screw. The screw is then inserted to the desired depth using the drive mechanism, which is then removed leaving the extension attached to the pedicle screw assembly.
[0039] A rod transfer tool is then inserted into the extension which is attached to the pedicle screw assembly with the poly-axial rod-assembly head until the distal end of the rod transfer tool locks with the end of the rod. The rod transfer tool is then used to disengage the rod from the drive mechanism of the pedicle screw, and guide the rod down into the extension holding the pedicle screw assembly with the poly-axial rod-capturing head, the end of rod ultimately being pressed down into the poly-axial rod-capturing head, where it is held in place by a clip ring in the rod-capturing head.
[0040] After the rod is pressed into the poly-axial rod-capturing head, the rod transfer tool is removed and locking caps are screwed into each of the poly-axial heads using a drive tool and counter torque handle assembly. The counter torque handle is used to provide a counter torque force to the torque applied by the drive tool, thereby preventing the loading of the rod assembly with torque when the locking caps are tightened into place.
[0041] After the locking caps are tightened appropriately, the extensions are removed leaving the stabilization system in place. Bone grafts can then be placed between the two stabilized vertebrae which will then grow to fuse the vertebrae together while the stabilization system holds the vertebral segment.
[0042] In addition to stabilization systems connection two bony structures, such as vertebrae, stabilization systems my be employed that rigidly connect three or more vertebrae.. In a three pedicle stabilization system, the outer poly-axial head assemblies are inserted into the first and second vertebrae, which surround the third vertebra, as described above. To position the third poly-axial head assembly, an arc defining tool is required since the rod has a predefined curvature and the third, or middle, poly-axial head assembly must be precisely located to capture the middle of the rod when it is transferred. Additionally, because of the additional length and curvature of the three pedicle rod over the two pedicle rod, the end of the rod with the drive mechanism is formed with an angle to the drive mechanism to minimize the diameter of the extension required. The additional length of the rod also requires a different rod transfer tool to move the rod into position in the poly-axial head assemblies, and an extension for the middle poly-axial head assembly.
[0043] FIGURE 1 shows stabilization assembly 10 which includes poly-axial head assemblies 100 and 200 shown interconnected by rod 700. Rod 700 is shown fastened securely to assemblies 100 and 200 by locking caps 1800. As described above, poly-axial rod capturing assembly 100 is anchored in the patient's pedicle by anchor 500 along a guide wire which passes through off axis screw guide 504 in anchor 500. When assembly 100 is positioned, a measurement is taken to the pedicle where the second assembly is to be positioned. This measurement determines the length of rod 700. The poly-axial rod-assembly 200 with proper size rod 700 is chosen and assembly 200, witli anchor 500 attached to head 300, is positioned in the selected other pedicle with torque being applied to anchor 500 through drive mechanism in distal end 702 of rod which, at that point, is in-line with the longitudinal axis of assembly 200.
From the in-line position, rod 700 is rotated such that it has and end captured by poly-axial rod-capturing head 1500.
[0044] While stabilization assembly 10 is shown connected by rod 700, any type of connector for connecting anchor assemblies 100 and 200 could be used and is within the scope of the present invention. Such connectors could include any rod, implant, fastener, or brace used for the purpose of connecting anchors mounted in bony structures. Further such connectors may be rigid, as rod 700, may be elastic, as bands, cables or artificial ligaments, or may be dynamic such as the dynamic brace described in United States Patent Application, Serial Number 10/914,751 filed August 9, 2004 and entitled SYSTEM AND METHOD FOR DYNAMIC SKELETAL STABILIZATION, which is herein incorporated by reference.
[0045] FIGURES 2 and 3 show assembly 1101, which has poly-axial head 300, anchor 500, rod 700 and slide ring 800. Slide ring 800 allows rod 700 to translate in position so that proximal end 701 can be carefully adjusted to fit into poly-axial rod capturing head 1500 of assembly 100 as shown in FIGURE 1. Rod 700 includes a distal end 702 with a drive mechanism, and a proximal end 701 shaped such that is can be captured by poly-axial rod-capturing head 1500 shown in FIGURE 1.
[0046] To create a tapped hole in a pedicle, the surgeon inserts a bone biopsy needle into the bone. Then the top portion of the bone biopsy needle is removed and pulled out leaving a cannula (an open tube) extending from outside the patient down to the newly created hole in the bone. A guide wire, which can have a diameter on the order of two millimeters, is passed down inside the cannula and over the guide wire and dilators are sent down to create a passageway between the muscle tissue.
[0047] Next, the anchor, or bone screw, must be inserted into the hole.
Typically, a cannulated screw is used with a hole all the way through the longitudinal axis. Because some of the screws an be as small as 5.5 millimeters on the major diameter, the minor diameter is extremely small. Consequently, only a very small hole will work because otherwise the screw loses strength. Thus, the holes tend to be small, on the order of 1 millimeter. However, even with a cannulation of 1 millimeter the screws may break, either as a result of misplacement, or when they are used on heavy or active patients. Also, a small cannulation diameter requires a small guide wire, which in turn creates several problems for the surgeon. Small wires can kink, or become bent, or get caught when the screw is being advanced.
[0048] When a guide wire is caught inside a screw it begins to advance with the screw and can move beyond the plane of the vertebral body thereby puncturing through the anterior portion of the vertebral body causing trauma to the soft tissue and vessels anterior to the vertebral body. The anchor of the present invention, which is formed with the off-axis screw guide, together with a cannula with a groove down its entire length allows the guide wire to remain outside the cannula while the screw is within the cannula. This allows for much thicker guide wires to be used, for example 2 millimeters in diameter, without sacrificing the strength of the screw or having guide wire issues of kinking or wire advancement while the screw is being positioned.
[0049] FIGURES 2 and 3 further illustrate rod 700 which has distal end 702 in which a drive mechanism is positioned. Rod 700 also includes rod curved body portion 703 in which the rod is partially curved to conform to a patient.
Sliding surfaces 705 are constructed to engage with slide ring 800.
[0050] Proximal end 701 of rod 700 must accomplish at least two functions, first driving the rod/poly-axial head assembly as an extension of a driver and second being captured by poly-axial rod-capturing assembly 1500, which allows for the repositioning of rod 700 from the in-line position shown in FIGURE 2 to the "horizontal" position for mating with assembly 100 as shown in FIGURE 3.
[0051] Proximal end 701 of rod 700 also includes a spherical portion having a diameter larger than the diameter of rod 700 for the purposes of allowing the cavity of poly-axial rod-capturing head 1500 from FIGURE 1 to capture rod 700 and to keep the spherical portion engaged with head 1500.
[0052] Proximal end of rod 700 must also be capable of being captured by rod transfer tool 5700 shown in FIGURES 4-15, such that the rod transfer tool is engaged with rod 700 until it is nearing the horizontal position at which point rod 700 must disengage from the rod transfer tool so that it may be engaged with the poly-axial rod-capturing head. A rod transfer tool engagement mechanism described in detail with referenc to FIGURES 9, 10, 12 and 13, which is duplicated on the opposing side of the spherical portion includes a ramp which allows tines 5905a and b from FIGURE 6 of the rod transfer tool to slide up, over a lip, and into a recess in end 701, thereby engaging end 701 with the rod transfer tool until tines 5905a and b of rod transfer too15700 are turned to the point that they can slide out of exit ranlp 716, which controls the release of the tine from end 701. While engaged in recess 713, tines 5905a and b are free to rotate about an axis normal to flats 712a and 712b.
[0053] As the tool pushes on proximal end 701, that end rotates toward assembly 100 of FIGURE 1 until end 701 of rod 700 is in position to be captured by head 1500. At that point, the angle of rod 700 with the pushing instrument is such that the tines of the instrument are pushed out of cylindrical recess 713 and out through exit ramp 716, as shown in FIGURE 7, thereby releasing proximal end 701 to be engaged into head 1500. The operation of rod transfer engagement mechanism, along with the distal end of the rod transfer tool of FIGURE 4 will be discussed with greater detail with reference to FIGURES 10 and 13.
[0054] Once engaged with both heads 300 and 1500, locking caps can be inserted into each of heads 300 and 1500, such that the ends of the locking caps are engaged with locking surfaces, which are preferably curved to have a locking cap, not force rod 700 into a position that is normal to the bottom of the locking cap, but rather a position that allows rod 700 to assume its natural rotation. Thereby allowing for installation of the rod in positions that accounts for variations in anatomical positioning of the vertebral bodies.
[0055] Slide ring 800, shown in FIGURE 2, facilitates up-down movement of rod 700 with respect to assembly 1101. This then allows for a variation in height of the rod to occur when the rod is in process of being translated from an in-line position to an approximately 90 degree position for engaging rod-capturing assembly 100.
[0056] FIGURE 2 shows a complete poly-axial rod assembly 1101 formed by anchor 500 mated with poly-axial rod assembly head 300 which is in turn holding rod 700, where rod 700 is shown in its in-line orientation with anchor 500.
[0057] FIGURE 3 shows rod 700 in the process of being translated from the in-line orientation such as would occur when rod 700 is being rotated for mating with a rod-capturing head assembly (not shown). The procedure and tool used for this translation will be described with reference to FIGURES 4-15. Note that during this translation, ears 802a and 802b, shown as FIGURE 2, move upward in opening 326a while rod 700 is free to move laterally with respect to head 300 via flats 705 riding in the slide ring.
[0058] FIGURES 4 and 5 illustrate one example of a rod transfer tool 5700.
The handle is a"pistol grip" having elongated portion 5702 and an elongated portion 5703 which rotates about pin 5704 to form a trigger. The trigger pushes sliding member 5705 which moves along elongated portion 5706. Movement of portion 5706 operates to rotate distal end portion 5707 about pin 5708. As slider 5705 moves forward, distal arm 5707 rotates about pin 5708 as shown in FIGURE 5. Pin 5709 allows for partial pushing motion between slider 5705 and end portion 5707. Distal end 5710 transcribes on arc as it rotates upward as is shown in FIGURE 5.
[0059] FIGURE 6 shows details of arm 5707 partially rotated about pin 5709. Racetrack cut 5909 allows pin 5709 in the proximal end of arm 5707 to move from the up position to the down position and then back up to the top. Flat area 5902 of arm 5707 engages slider 5705 and handle 5706. Rod transfer tool 5700 is designed to grasp rod 700 at proximal end 701 and pulls rod 700 along the path to poly-axial rod capturing assembly 1500, at which point rod transfer tool 5700, by means of cam 5908 pushes rod 700 out of arm 5707 and toward head 1500. At no time does rod transfer tool 5700 apply pressure to the sides , top or bottom of rod 700.
[0060] Distal end 5710 has bore 5906 which is a pocket having cut 5910 for purposes of pushing the rod and urging the rod down into poly-axial rod-capturing assembly 100 from FIGURE 1 wlien the rod is being transferred. End 5710 also has two tines 5905a and 5905b in pocket 5906. Channel cut 5907 allows tines 5905a and 5905b to be sprung away from one another when they are being inserted onto the spherical portion 711 of rod 700. Raised radial surface 5908 acts as a cam to push the rod away from arm 5707 when the rod meets the particular exit angle as will be described hereinafter.
[0061] FIGURE 7 shows pocket 5906 of arm 5707 as well as spherical portion 701 of rod 700. Note that channels 713 in the rod end allow tines 5905a and 5905b to exit from rod end 701 when the rod is rotated into position. The tines enter via opening 715 which is sloped to act as a ramp to facilitate entrance of the tines. Tines 5905a and 5905b have partially radial surfaces 6001, interrupted by flat cut surfaces 6002.
[0062] FIGURE 8 shows how instrument 5700 operates, reference will be made to rod 700 and its features shown in FIGURES 2 and 3. Once poly-axial rod assembly 200 from FIGURE 1 is inserted into the bone with extension 3001 connected to head 300, instrument 5700 is inserted down the bore of extension 3001 as shown. Distal end 5710 of tool 5700 engages proximal end 701 of rod 700 causing tines 5905a and 5905b to splay apart as they engage the ramp at the proximal end of the rod, as discussed above. When the tines get to lip 722 of ramp 715 they drop into recess 713.
The shape of tines 5905 a and b insure that they remain in recess 713 until the end of tool 5700 is rotated into the release position. Tines 5805a and b have a large diameter which is perpendicular to exit ramp 716 and larger than the transition from recess 713 to exit ramp 716. Tines 5905 a and b also have a small diameter which becomes perpendicular to exit ramp 716 upon the rotation of rod 700 in too15700. The small diameter of tines 5905a and b is smaller than the transition to exit ramp 716 allowing tines 5905a and b to exit their engagement with rod 700 at the proper orientation.
[0063] Once the rod 700 is engaged with too15700, upward pulling force is exerted by the surgeon which lifts rod 700 out of mating relationship with anchor 500 by disengaging the drive mechanism of rod 700 from the drive of anchor 500.
Pulling up moves slide ring 800 to the top of channel 326a, b shown in FIGURE 2 so that the distal end of the rod clears the top of the drive mechanism as it rotates over. By squeezing the trigger 5703 of too15700, the surgeon begins the rotation of arm 5707 which, in turn, causes rod 700 to pass through the open slot portion of extension 3001.
[0064] FIGURE 9 is a section taken through lines 62-62 of FIGURE 8 illustrating ramp 715, channel cut 5907 and arm 5707. Tines 5905a and 5905b are snapped into cylindrical recesses 713 on rod 700. The rod is captured and can be pulled up as discussed above.
[0065] FIGURE 60 is a cut-away view illustrating the orientation of tine 5905a in rod hole 713. Rod arm 5707 has pocket 5906 around rod 700. Tines 5905 a and b (b not being shown) entered via ramp 715. Tines 5905a and has four surfaces. It has flat surfaces 6002a and 6002b on the small diameter and curved surfaces 6001 a and 6001b on the large diameter. As stated, once the tines snap into the holes they cannot come out until arm 5707 is rotated so that the flats on the tines line up with exit slot 710.
This can only occur when arm 5707 moves through an arc of approximately 90 .
[0066] FIGURE 11 illustrates too15700 in operation with arm 5707 rotating rod 700 from extension 3001a into extension 3001b. Extension 3001b includes two openings. The first opening 3103 is the largest opening with a distance d2. The second opening is opening 3104 has a reduced distance dl. This change of distance is important during rod transfer (rotation from in-line to horizontal) because the rod proximal end enters tube 3001 at 3103 and is guided into the poly-axial head held by tube 3002 by the reduced opening formed by distance d2. Note the angle that arm 5707 of tool 5700 is making with respect to the proximal end of rod 700. The design is such that once the rod end enters wide opening 3103 of extension 3001b, the tine flats will line up with the exit ramps (as discussed with respect to FIGURE 10) and with the help of cam 5908 will release therefrom.
[0067] FIGURE 12 shows a cross-section through section 65a-65a of FIGURE 11 and illustrates tines 5905a and 5905b in pocket 5906 but radial surfaces 6001 a and 6001b can now pass through exit slots 716. FIGUTRE 13 is a cross section through section 65b-65b of Figure 65a and again shows the small diameter of tines 5905a and be aligned to pass through the transition between recesses 713 and exit slots 716. Cam 5708 is also shown which, as it rotates, operates to push the rod end out of pocket 5906.
[0068] Another embodiment of a rod transfer tool 6900 is shown in FIGURE 14. Too16900 has shaft 6902 and handle 6903. It has distal arm 5707 connected to shaft 6902 by pivots 6904, which is the same as discussed above with respect to tool 5700 from FIGURES 4 and 5. Tool 6900 and shaft 6902 can be used to span three or more pedicles through three extensions as shown in FIGURE 15.
[0069] In operation, distal arm 5707, which is part of the multi-level rod transfer device 6900, is placed through window 3102 and then tines of arm 5707 are snapped onto the proximal end of rod 6600 as discussed above. Then the instrument is lifted to disengage the rod/screw drive mechanism. Next, using handle 6903, the rod is pushed out of extension 3001 via opening 3103.
[0070] FIGURE 15 shows, in cut-away, a multi-level setup where assembly 7000 has been added to a center pedicle between assemblies 100 and 200.
Assembly 7000 is the same as assembly 100 except that slider 800 is omitted as it is not required.
[0071] Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.
Throughout this movement, when the spine is operating properly the nerves are maintained clear of the hard structure of the spine.
[00051 Over time, or because of accidents, the intervertebral discs loose height, become cracked, dehydrated, or herniated. The result is that the disc height is reduced leading to compression of the nerve bundles, causing pain and in some cases damage to the nerves.
[0006] Currently, there are many systems and methods at the disposal of a physician for reducing, or eliminating, the pain by minimizing the stress on the nerve bundles. In some instances, the existing disk is removed and an artificial disk is substituted therefore. In other instances, two or more vertebrae are fused together to prevent relative movement between the fused discs.
[0007] Often there is required a system and method for maintaining, or recreating, proper space for the nerve bundles that emerge from the spine at a certain location. In some cases a cage or bone graft is placed in the disc space to preserve, or restore, height and to cause fusion of the vertebral level. As an aid in stabilizing the vertebrae, one or more rods or braces are placed between the fused vertebrae with the purpose of the rods being to support the vertebrae, usually along the posterior of the 25584719.1 3 spine while fusion takes place. These rods are often held in place by anchors which are fitted into the pedicle of the vertebrae. One type of anchor is a pedicle screw, and such screws come in a variety of lengths, diameters, and thread types.
[0008] One problem occurs attempting to position a rod to span between anchors positioned in bones such as vertebrae. Once solution to the problem of positioning a rod is described in U.S. Application Serial Number 10/690,211 filed October 21, 2003 entitled SYSTEM AND METHOD FOR STABILIZING INTERNAL
STRUCTURES, which is hereby incorporated by reference, and shows a rod pre-attached to a first anchor by means of a hinge, such that the proximal end of the rod may be rotated toward a second anchor. The proximal end of the rod may be captured by a capturing hinge attached to the second anchor, the capturing hinge including a mechanism for locking the proximal end of the rod in place. What is needed is a tool operable to rotate the proximal end of the rod toward the second anchor and into the capturing hinge.
BRIEF SUMMARY OF THE INVENTION
[0009] The present invention describes various embodiments of tools for use in spinal stabilization procedures. The tool is used to transfer a rod or other stabilization device in an assembly from a first bone anchor assembly to a second bone anchor assembly inserted into a first and second bony structure, such as the pedicle of a vertebra.
[0010] A medical instrument characterized by: an elongated body having a proximal and distal end; a handle coupled to the proximal end; wherein the distal end includes: a means for pivotally coupling to a bone anchor connector such that the connector can rotate about its distal end from a first angular position to a second angular position, and a means for locking and unlocking the distal end to the connector, wherein when the connector is in the first angular position the connector may be locked to the distal end and when the connector is in the second angular position, the connector may be unlocked to the distal end.
[0011] The medical instrument may be further characterized in that the means for pivotally coupling further comprises: an enlarged end having a pocket for partially enclosing a portion of the connector, and at least one tine for rotatingly engaging a recess in the connector, wherein the tine is positioned within the pocket.
Furthermore, the means for locking and unlocking may further comprise at least one elongated tine sized to be restrained by an opening in the connector when the tine is in one angular position relative to the connector and to be able to pass through the opening when the tine is in a second angular position relative to the connector.
[0012] The medical instrument may also be further characterized in that the means for locking and unlocking further comprises the second portion having a cam for causing the connector to disengage from the said connector engagement mechanism as said second arm reaches said second orientation.
[0013] There may also be a means for biasing the tine such that the tine stays in the recess when the tine is in the first angular position.
[00141 The medical instrument may be further characterized in that the elongated body further comprises an in-line portion for positioning within a first extension, an in-line portion having at least one hinge for allowing a second portion of the distal end to move from the in-line position to a flexed position.
[0015] There may also be an articulating means for controlling the movement of the second portion coupled to the proximal end.
[0016] The medical instrument may even further be characterized by a means for providing a tactile or audible feedback indication when the connector is locked to the distal end.
[0017] There may also be implant system characterized by: a medical instrument characterized by: an elongated body having a proximal and distal end; a handle coupled to the proximal end; wherein the distal end includes: a means for pivotally coupling to a bone anchor connector such that the connector can rotate about its distal end from a first angular position to a second angular position, and a means for locking and unlocking the distal end to the connector, wherein when the connector is in the first angular position the connector may be locked to the distal end and when the connector is in the second angular position, the connector may be unlocked to the distal end; wherein the medical instrument may be further characterized in that the means for pivotally coupling further comprises: an enlarged end having a pocket for partially enclosing a portion of the connector, and at least one tine for rotatingly engaging a recess in the connector, wherein the tine is positioned within the pocket; a rod-like connector, wherein the proximal end of the rod-like connector includes: at least one recess; a first channel leading to the recess for allowing the tine to following the channel then to drop into the recess; a second channel leading from the recess for allowing the tine to escape from the recess when the channel is in an unique orientation relative to the tine.
[0018] There maybe a connector for connecting at least two bone anchors, the connector characterized by: an elongated body having a proximal and distal end;
wherein the proximal end includes: two recesses on opposing sides of the distal end; a pair of channels leading to the recess for allowing a tine of a medical instrument to following a channel then to drop into the recess; a second pair of channels leading the recess for allowing the tine to escape from the recess when the channel is in an unique orientation relative to the tine.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which:
[0020] FIGURE 1 is a perspective view of an embodiment of an internal stabilization system in accordance with the present invention;
[0021] FIGURE 2 is a perspective view of the rod and anchor assembly of FIGURE 10A mounted with the head of FIGURE 3;
[0022] FIGURE 3 is a perspective view of the rod, anchor and head assembly of FIGURE 11 where the drive mechanism of the rod has been disengaged from the anchor and rotated within the head;
[0023] FIGURE 4 is a perspective view of a rod transfer tool in accordance with the present invention;
[0024] FIGIJRE 5 is a perspective view of the rod transfer tool of FIGURE
4 with the distal arm bent upward;
[0025] FIGURE 6 shows is a perspective view of the distal arm end of the rod transfer tool of FIGURE 47;
[0026] FIGURE 7 is a side view of the tip of the distal arm of the rod transfer tool of FIGURE 4.
[0027] FIGURE 8 is a side view of the rod transfer tool of FIGURE 57 in operation with the assemblies of FIGURE 2;
[0028] FIGURE 9 is a section view taken through lines 62-62 of FIGURE
8;
[0029] FIGURE 10 is a cut-away view illustrating the orientation of a tine of the rod transfer tool of FIGURE 4 with the distal end of the rod of FIGURE
2;
[0030] FIGURE 11 is a side view the rod transfer tool of FIGURE 4 operating to transfer a rod from the assembly of FIGURE 2 into the capturing head of the assembly of FIGURE 1;
[0031] FIGURE 12 shows a cross-section through section 65a-65a of FIGURE 11;
[0032] FIGURE 13 shows a cross-section through 65b-65b of FIGURE 12;
[0033] FIGURE 14 is a side view of a multi-pedicle assembly with a tool shown rotating the rod into position;
[0034] FIGURE 15 is a side view of a three pedicle assembly according to the present invention;
DETAILED DESCRIPTION OF THE INVENTION
[0035] To better understand the devices, assemblies, tools, and methods described below, and understanding of the procedure through which the back stabilization of the present invention is placed into the vertebrae of a patient is required.
Reference is made to the figure numbers where specific embodiments of the tools are described in greater detail to aid in the understanding of those particular items.
[0036] An operation to insert a pedicle screw assembly into a patient's back to immobilize certain vertebrae in order to allow bone grafts to ultimately fuse those vertebrae begins with the surgeon inserting a standard bone biopsy needle into the pedicle of a first vertebra and using the bone biopsy needle to place a guide wire where the first pedicle screw should be inserted. Using the guide wire, progressively larger tissue expanders are inserted into the patient to expand, or dilate, the incision to the size necessary to accommodate the instruments to be used, with the fmal cannula being left in the incision after the smaller ones are removed. Next, an awl is used to enlarge the hole in the pedicle made by the bone biopsy needle with the awl being inserted over the guide wire to ensure proper placement in the pedicle. A tap, having a diameter slightly smaller than the pedicle screw to be used, is inserted down the guide wire and used to tap the hole started by the bone biopsy needle and the awl, making it ready to accept the first pedicle screw.
[0037] A first pedicle screw with a poly-axial rod-capturing head attached to form a rod-capturing pedicle screw assembly is inserted down the guide wire using the off-axis screw guide of the pedicle screw and into the hole left by the tap.
Attached to this pedicle screw assembly are an extension and drive mechanism with a torque head attachment. The extension allows access to the pedicle screw assembly once it is in place. The drive mechanism is used to screw the pedicle screw assembly in place and is removed from the extension once the pedicle screw assembly is set to the desired depth.
[0038] A tissue separator is used to make a path from the first and second, and potentially additional, vertebra where the second pedicle screw assembly will be inserted. As described above a bone biopsy needle is used to insert a guide wire into the second vertebra where the second pedicle screw assembly is to be placed. Once the guide wire is in place a measurement tool is used measure the distance between the first 25584719.1 10 pedicle screw assembly and the guide wire, the measurement determining the length of the rod to be used. The second pedicle screw assembly is then chosen according to the proper length of the rod. The second pedicle screw assembly is formed by a pedicle screw identical to the pedicle screw of the first assembly, a poly-axial rod-assembly head, a slide ring, and a rod all connected to another extension. A drive mechanism with a head to accept the end of the rod is used to drive the second pedicle screw assembly into the pedicle of the second vertebra, using the rod to transfer torque fiom the drive mechanism to the pedicle screw. As before the pedicle screw is sent along the guide wire using the off-axis screw guide in the pedicle screw. The screw is then inserted to the desired depth using the drive mechanism, which is then removed leaving the extension attached to the pedicle screw assembly.
[0039] A rod transfer tool is then inserted into the extension which is attached to the pedicle screw assembly with the poly-axial rod-assembly head until the distal end of the rod transfer tool locks with the end of the rod. The rod transfer tool is then used to disengage the rod from the drive mechanism of the pedicle screw, and guide the rod down into the extension holding the pedicle screw assembly with the poly-axial rod-capturing head, the end of rod ultimately being pressed down into the poly-axial rod-capturing head, where it is held in place by a clip ring in the rod-capturing head.
[0040] After the rod is pressed into the poly-axial rod-capturing head, the rod transfer tool is removed and locking caps are screwed into each of the poly-axial heads using a drive tool and counter torque handle assembly. The counter torque handle is used to provide a counter torque force to the torque applied by the drive tool, thereby preventing the loading of the rod assembly with torque when the locking caps are tightened into place.
[0041] After the locking caps are tightened appropriately, the extensions are removed leaving the stabilization system in place. Bone grafts can then be placed between the two stabilized vertebrae which will then grow to fuse the vertebrae together while the stabilization system holds the vertebral segment.
[0042] In addition to stabilization systems connection two bony structures, such as vertebrae, stabilization systems my be employed that rigidly connect three or more vertebrae.. In a three pedicle stabilization system, the outer poly-axial head assemblies are inserted into the first and second vertebrae, which surround the third vertebra, as described above. To position the third poly-axial head assembly, an arc defining tool is required since the rod has a predefined curvature and the third, or middle, poly-axial head assembly must be precisely located to capture the middle of the rod when it is transferred. Additionally, because of the additional length and curvature of the three pedicle rod over the two pedicle rod, the end of the rod with the drive mechanism is formed with an angle to the drive mechanism to minimize the diameter of the extension required. The additional length of the rod also requires a different rod transfer tool to move the rod into position in the poly-axial head assemblies, and an extension for the middle poly-axial head assembly.
[0043] FIGURE 1 shows stabilization assembly 10 which includes poly-axial head assemblies 100 and 200 shown interconnected by rod 700. Rod 700 is shown fastened securely to assemblies 100 and 200 by locking caps 1800. As described above, poly-axial rod capturing assembly 100 is anchored in the patient's pedicle by anchor 500 along a guide wire which passes through off axis screw guide 504 in anchor 500. When assembly 100 is positioned, a measurement is taken to the pedicle where the second assembly is to be positioned. This measurement determines the length of rod 700. The poly-axial rod-assembly 200 with proper size rod 700 is chosen and assembly 200, witli anchor 500 attached to head 300, is positioned in the selected other pedicle with torque being applied to anchor 500 through drive mechanism in distal end 702 of rod which, at that point, is in-line with the longitudinal axis of assembly 200.
From the in-line position, rod 700 is rotated such that it has and end captured by poly-axial rod-capturing head 1500.
[0044] While stabilization assembly 10 is shown connected by rod 700, any type of connector for connecting anchor assemblies 100 and 200 could be used and is within the scope of the present invention. Such connectors could include any rod, implant, fastener, or brace used for the purpose of connecting anchors mounted in bony structures. Further such connectors may be rigid, as rod 700, may be elastic, as bands, cables or artificial ligaments, or may be dynamic such as the dynamic brace described in United States Patent Application, Serial Number 10/914,751 filed August 9, 2004 and entitled SYSTEM AND METHOD FOR DYNAMIC SKELETAL STABILIZATION, which is herein incorporated by reference.
[0045] FIGURES 2 and 3 show assembly 1101, which has poly-axial head 300, anchor 500, rod 700 and slide ring 800. Slide ring 800 allows rod 700 to translate in position so that proximal end 701 can be carefully adjusted to fit into poly-axial rod capturing head 1500 of assembly 100 as shown in FIGURE 1. Rod 700 includes a distal end 702 with a drive mechanism, and a proximal end 701 shaped such that is can be captured by poly-axial rod-capturing head 1500 shown in FIGURE 1.
[0046] To create a tapped hole in a pedicle, the surgeon inserts a bone biopsy needle into the bone. Then the top portion of the bone biopsy needle is removed and pulled out leaving a cannula (an open tube) extending from outside the patient down to the newly created hole in the bone. A guide wire, which can have a diameter on the order of two millimeters, is passed down inside the cannula and over the guide wire and dilators are sent down to create a passageway between the muscle tissue.
[0047] Next, the anchor, or bone screw, must be inserted into the hole.
Typically, a cannulated screw is used with a hole all the way through the longitudinal axis. Because some of the screws an be as small as 5.5 millimeters on the major diameter, the minor diameter is extremely small. Consequently, only a very small hole will work because otherwise the screw loses strength. Thus, the holes tend to be small, on the order of 1 millimeter. However, even with a cannulation of 1 millimeter the screws may break, either as a result of misplacement, or when they are used on heavy or active patients. Also, a small cannulation diameter requires a small guide wire, which in turn creates several problems for the surgeon. Small wires can kink, or become bent, or get caught when the screw is being advanced.
[0048] When a guide wire is caught inside a screw it begins to advance with the screw and can move beyond the plane of the vertebral body thereby puncturing through the anterior portion of the vertebral body causing trauma to the soft tissue and vessels anterior to the vertebral body. The anchor of the present invention, which is formed with the off-axis screw guide, together with a cannula with a groove down its entire length allows the guide wire to remain outside the cannula while the screw is within the cannula. This allows for much thicker guide wires to be used, for example 2 millimeters in diameter, without sacrificing the strength of the screw or having guide wire issues of kinking or wire advancement while the screw is being positioned.
[0049] FIGURES 2 and 3 further illustrate rod 700 which has distal end 702 in which a drive mechanism is positioned. Rod 700 also includes rod curved body portion 703 in which the rod is partially curved to conform to a patient.
Sliding surfaces 705 are constructed to engage with slide ring 800.
[0050] Proximal end 701 of rod 700 must accomplish at least two functions, first driving the rod/poly-axial head assembly as an extension of a driver and second being captured by poly-axial rod-capturing assembly 1500, which allows for the repositioning of rod 700 from the in-line position shown in FIGURE 2 to the "horizontal" position for mating with assembly 100 as shown in FIGURE 3.
[0051] Proximal end 701 of rod 700 also includes a spherical portion having a diameter larger than the diameter of rod 700 for the purposes of allowing the cavity of poly-axial rod-capturing head 1500 from FIGURE 1 to capture rod 700 and to keep the spherical portion engaged with head 1500.
[0052] Proximal end of rod 700 must also be capable of being captured by rod transfer tool 5700 shown in FIGURES 4-15, such that the rod transfer tool is engaged with rod 700 until it is nearing the horizontal position at which point rod 700 must disengage from the rod transfer tool so that it may be engaged with the poly-axial rod-capturing head. A rod transfer tool engagement mechanism described in detail with referenc to FIGURES 9, 10, 12 and 13, which is duplicated on the opposing side of the spherical portion includes a ramp which allows tines 5905a and b from FIGURE 6 of the rod transfer tool to slide up, over a lip, and into a recess in end 701, thereby engaging end 701 with the rod transfer tool until tines 5905a and b of rod transfer too15700 are turned to the point that they can slide out of exit ranlp 716, which controls the release of the tine from end 701. While engaged in recess 713, tines 5905a and b are free to rotate about an axis normal to flats 712a and 712b.
[0053] As the tool pushes on proximal end 701, that end rotates toward assembly 100 of FIGURE 1 until end 701 of rod 700 is in position to be captured by head 1500. At that point, the angle of rod 700 with the pushing instrument is such that the tines of the instrument are pushed out of cylindrical recess 713 and out through exit ramp 716, as shown in FIGURE 7, thereby releasing proximal end 701 to be engaged into head 1500. The operation of rod transfer engagement mechanism, along with the distal end of the rod transfer tool of FIGURE 4 will be discussed with greater detail with reference to FIGURES 10 and 13.
[0054] Once engaged with both heads 300 and 1500, locking caps can be inserted into each of heads 300 and 1500, such that the ends of the locking caps are engaged with locking surfaces, which are preferably curved to have a locking cap, not force rod 700 into a position that is normal to the bottom of the locking cap, but rather a position that allows rod 700 to assume its natural rotation. Thereby allowing for installation of the rod in positions that accounts for variations in anatomical positioning of the vertebral bodies.
[0055] Slide ring 800, shown in FIGURE 2, facilitates up-down movement of rod 700 with respect to assembly 1101. This then allows for a variation in height of the rod to occur when the rod is in process of being translated from an in-line position to an approximately 90 degree position for engaging rod-capturing assembly 100.
[0056] FIGURE 2 shows a complete poly-axial rod assembly 1101 formed by anchor 500 mated with poly-axial rod assembly head 300 which is in turn holding rod 700, where rod 700 is shown in its in-line orientation with anchor 500.
[0057] FIGURE 3 shows rod 700 in the process of being translated from the in-line orientation such as would occur when rod 700 is being rotated for mating with a rod-capturing head assembly (not shown). The procedure and tool used for this translation will be described with reference to FIGURES 4-15. Note that during this translation, ears 802a and 802b, shown as FIGURE 2, move upward in opening 326a while rod 700 is free to move laterally with respect to head 300 via flats 705 riding in the slide ring.
[0058] FIGURES 4 and 5 illustrate one example of a rod transfer tool 5700.
The handle is a"pistol grip" having elongated portion 5702 and an elongated portion 5703 which rotates about pin 5704 to form a trigger. The trigger pushes sliding member 5705 which moves along elongated portion 5706. Movement of portion 5706 operates to rotate distal end portion 5707 about pin 5708. As slider 5705 moves forward, distal arm 5707 rotates about pin 5708 as shown in FIGURE 5. Pin 5709 allows for partial pushing motion between slider 5705 and end portion 5707. Distal end 5710 transcribes on arc as it rotates upward as is shown in FIGURE 5.
[0059] FIGURE 6 shows details of arm 5707 partially rotated about pin 5709. Racetrack cut 5909 allows pin 5709 in the proximal end of arm 5707 to move from the up position to the down position and then back up to the top. Flat area 5902 of arm 5707 engages slider 5705 and handle 5706. Rod transfer tool 5700 is designed to grasp rod 700 at proximal end 701 and pulls rod 700 along the path to poly-axial rod capturing assembly 1500, at which point rod transfer tool 5700, by means of cam 5908 pushes rod 700 out of arm 5707 and toward head 1500. At no time does rod transfer tool 5700 apply pressure to the sides , top or bottom of rod 700.
[0060] Distal end 5710 has bore 5906 which is a pocket having cut 5910 for purposes of pushing the rod and urging the rod down into poly-axial rod-capturing assembly 100 from FIGURE 1 wlien the rod is being transferred. End 5710 also has two tines 5905a and 5905b in pocket 5906. Channel cut 5907 allows tines 5905a and 5905b to be sprung away from one another when they are being inserted onto the spherical portion 711 of rod 700. Raised radial surface 5908 acts as a cam to push the rod away from arm 5707 when the rod meets the particular exit angle as will be described hereinafter.
[0061] FIGURE 7 shows pocket 5906 of arm 5707 as well as spherical portion 701 of rod 700. Note that channels 713 in the rod end allow tines 5905a and 5905b to exit from rod end 701 when the rod is rotated into position. The tines enter via opening 715 which is sloped to act as a ramp to facilitate entrance of the tines. Tines 5905a and 5905b have partially radial surfaces 6001, interrupted by flat cut surfaces 6002.
[0062] FIGURE 8 shows how instrument 5700 operates, reference will be made to rod 700 and its features shown in FIGURES 2 and 3. Once poly-axial rod assembly 200 from FIGURE 1 is inserted into the bone with extension 3001 connected to head 300, instrument 5700 is inserted down the bore of extension 3001 as shown. Distal end 5710 of tool 5700 engages proximal end 701 of rod 700 causing tines 5905a and 5905b to splay apart as they engage the ramp at the proximal end of the rod, as discussed above. When the tines get to lip 722 of ramp 715 they drop into recess 713.
The shape of tines 5905 a and b insure that they remain in recess 713 until the end of tool 5700 is rotated into the release position. Tines 5805a and b have a large diameter which is perpendicular to exit ramp 716 and larger than the transition from recess 713 to exit ramp 716. Tines 5905 a and b also have a small diameter which becomes perpendicular to exit ramp 716 upon the rotation of rod 700 in too15700. The small diameter of tines 5905a and b is smaller than the transition to exit ramp 716 allowing tines 5905a and b to exit their engagement with rod 700 at the proper orientation.
[0063] Once the rod 700 is engaged with too15700, upward pulling force is exerted by the surgeon which lifts rod 700 out of mating relationship with anchor 500 by disengaging the drive mechanism of rod 700 from the drive of anchor 500.
Pulling up moves slide ring 800 to the top of channel 326a, b shown in FIGURE 2 so that the distal end of the rod clears the top of the drive mechanism as it rotates over. By squeezing the trigger 5703 of too15700, the surgeon begins the rotation of arm 5707 which, in turn, causes rod 700 to pass through the open slot portion of extension 3001.
[0064] FIGURE 9 is a section taken through lines 62-62 of FIGURE 8 illustrating ramp 715, channel cut 5907 and arm 5707. Tines 5905a and 5905b are snapped into cylindrical recesses 713 on rod 700. The rod is captured and can be pulled up as discussed above.
[0065] FIGURE 60 is a cut-away view illustrating the orientation of tine 5905a in rod hole 713. Rod arm 5707 has pocket 5906 around rod 700. Tines 5905 a and b (b not being shown) entered via ramp 715. Tines 5905a and has four surfaces. It has flat surfaces 6002a and 6002b on the small diameter and curved surfaces 6001 a and 6001b on the large diameter. As stated, once the tines snap into the holes they cannot come out until arm 5707 is rotated so that the flats on the tines line up with exit slot 710.
This can only occur when arm 5707 moves through an arc of approximately 90 .
[0066] FIGURE 11 illustrates too15700 in operation with arm 5707 rotating rod 700 from extension 3001a into extension 3001b. Extension 3001b includes two openings. The first opening 3103 is the largest opening with a distance d2. The second opening is opening 3104 has a reduced distance dl. This change of distance is important during rod transfer (rotation from in-line to horizontal) because the rod proximal end enters tube 3001 at 3103 and is guided into the poly-axial head held by tube 3002 by the reduced opening formed by distance d2. Note the angle that arm 5707 of tool 5700 is making with respect to the proximal end of rod 700. The design is such that once the rod end enters wide opening 3103 of extension 3001b, the tine flats will line up with the exit ramps (as discussed with respect to FIGURE 10) and with the help of cam 5908 will release therefrom.
[0067] FIGURE 12 shows a cross-section through section 65a-65a of FIGURE 11 and illustrates tines 5905a and 5905b in pocket 5906 but radial surfaces 6001 a and 6001b can now pass through exit slots 716. FIGUTRE 13 is a cross section through section 65b-65b of Figure 65a and again shows the small diameter of tines 5905a and be aligned to pass through the transition between recesses 713 and exit slots 716. Cam 5708 is also shown which, as it rotates, operates to push the rod end out of pocket 5906.
[0068] Another embodiment of a rod transfer tool 6900 is shown in FIGURE 14. Too16900 has shaft 6902 and handle 6903. It has distal arm 5707 connected to shaft 6902 by pivots 6904, which is the same as discussed above with respect to tool 5700 from FIGURES 4 and 5. Tool 6900 and shaft 6902 can be used to span three or more pedicles through three extensions as shown in FIGURE 15.
[0069] In operation, distal arm 5707, which is part of the multi-level rod transfer device 6900, is placed through window 3102 and then tines of arm 5707 are snapped onto the proximal end of rod 6600 as discussed above. Then the instrument is lifted to disengage the rod/screw drive mechanism. Next, using handle 6903, the rod is pushed out of extension 3001 via opening 3103.
[0070] FIGURE 15 shows, in cut-away, a multi-level setup where assembly 7000 has been added to a center pedicle between assemblies 100 and 200.
Assembly 7000 is the same as assembly 100 except that slider 800 is omitted as it is not required.
[0071] Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.
Claims (10)
1. A medical instrument characterized by:
an elongated body having a proximal and distal end;
a handle coupled to the proximal end;
wherein the distal end includes:
a means for pivotally coupling to a bone anchor connector such that the connector can rotate about its distal end from a first angular position to a second angular position, and a means for locking and unlocking the distal end to the connector, wherein when the connector is in the first angular position the connector may be locked to the distal end and when the connector is in the second angular position, the connector may be unlocked to the distal end.
an elongated body having a proximal and distal end;
a handle coupled to the proximal end;
wherein the distal end includes:
a means for pivotally coupling to a bone anchor connector such that the connector can rotate about its distal end from a first angular position to a second angular position, and a means for locking and unlocking the distal end to the connector, wherein when the connector is in the first angular position the connector may be locked to the distal end and when the connector is in the second angular position, the connector may be unlocked to the distal end.
2. The medical instrument according to claim 1, characterized in that the means for pivotally coupling further comprises:
an enlarged end having a pocket for partially enclosing a portion of the connector, and at least one tine for rotatingly engaging a recess in the connector, wherein the tine is positioned within the pocket.
an enlarged end having a pocket for partially enclosing a portion of the connector, and at least one tine for rotatingly engaging a recess in the connector, wherein the tine is positioned within the pocket.
3. The medical instrument according to claim 2, characterized in that the means for locking and unlocking further comprises at least one elongated tine sized to be restrained by an opening in the connector when the tine is in one angular position relative to the connector and to be able to pass through the opening when the tine is in a second angular position relative to the connector.
4. The medical instrument according to claim 1, characterized in that the means for locking and unlocking further comprises the second portion having a cam for causing the connector to disengage from the said connector engagement mechanism as said second arm reaches said second orientation.
5. The medical instrument according to claims 2 or 3 characterized by a means for biasing the tine such that the tine stays in the recess when the tine is in the first angular position.
6. The medical instrument according to claim 1 characterized in that the elongated body further comprises an in-line portion for positioning within a first extension, an in-line portion having at least one hinge for allowing a second portion of the distal end to move from the in-line position to a flexed position.
7. The medical instrument according to claim 4 characterized by an articulating means for controlling the movement of the second portion coupled to the proximal end.
8. The medical instrument according to claims 1 through 7 characterized by a means for providing a tactile or audible feedback indication when the connector is locked to the distal end.
9. An implant system characterized by:
the medical instrument of claim 2, and a rod-like connector, wherein the proximal end of the rod-like connector includes:
at least one recess;
a first channel leading to the recess for allowing the tine to following the channel then to drop into the recess;
a second channel leading from the recess for allowing the tine to escape from the recess when the channel is in an unique orientation relative to the tine.
the medical instrument of claim 2, and a rod-like connector, wherein the proximal end of the rod-like connector includes:
at least one recess;
a first channel leading to the recess for allowing the tine to following the channel then to drop into the recess;
a second channel leading from the recess for allowing the tine to escape from the recess when the channel is in an unique orientation relative to the tine.
10. A connector for connecting at least two bone anchors, the connector characterized by:
an elongated body having a proximal and distal end;
wherein the proximal end includes:
two recesses on opposing sides of the distal end;
a pair of channels leading to the recess for allowing a tine of a medical instrument to following a channel then to drop into the recess;
a second pair of channels leading the recess for allowing the tine to escape from the recess when the channel is in an unique orientation relative to the tine.
an elongated body having a proximal and distal end;
wherein the proximal end includes:
two recesses on opposing sides of the distal end;
a pair of channels leading to the recess for allowing a tine of a medical instrument to following a channel then to drop into the recess;
a second pair of channels leading the recess for allowing the tine to escape from the recess when the channel is in an unique orientation relative to the tine.
Applications Claiming Priority (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US61746104P | 2004-10-08 | 2004-10-08 | |
| US60/617,461 | 2004-10-08 | ||
| US10/990,272 | 2004-11-16 | ||
| US10/990,221 | 2004-11-16 | ||
| US10/990,272 US7618442B2 (en) | 2003-10-21 | 2004-11-16 | Implant assembly and method for use in an internal structure stabilization system |
| US10/990,221 US7905907B2 (en) | 2003-10-21 | 2004-11-16 | Internal structure stabilization system for spanning three or more structures |
| US10/989,782 | 2004-11-16 | ||
| US10/989,782 US7967826B2 (en) | 2003-10-21 | 2004-11-16 | Connector transfer tool for internal structure stabilization systems |
| PCT/US2005/036340 WO2006042189A2 (en) | 2004-10-08 | 2005-10-10 | Connector transfer tool for internal structure stabilization systems |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2581882A1 true CA2581882A1 (en) | 2006-04-20 |
Family
ID=35589605
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002581882A Abandoned CA2581882A1 (en) | 2004-10-08 | 2005-10-10 | Connector transfer tool for internal structure stabilization systems |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US7967826B2 (en) |
| EP (1) | EP1796565A2 (en) |
| AU (1) | AU2005294162A1 (en) |
| CA (1) | CA2581882A1 (en) |
| WO (1) | WO2006042189A2 (en) |
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-
2004
- 2004-11-16 US US10/989,782 patent/US7967826B2/en not_active Expired - Fee Related
-
2005
- 2005-10-10 WO PCT/US2005/036340 patent/WO2006042189A2/en active Application Filing
- 2005-10-10 EP EP05806488A patent/EP1796565A2/en not_active Withdrawn
- 2005-10-10 CA CA002581882A patent/CA2581882A1/en not_active Abandoned
- 2005-10-10 AU AU2005294162A patent/AU2005294162A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| AU2005294162A1 (en) | 2006-04-20 |
| EP1796565A2 (en) | 2007-06-20 |
| WO2006042189A2 (en) | 2006-04-20 |
| WO2006042189A3 (en) | 2006-10-05 |
| US20060079894A1 (en) | 2006-04-13 |
| US7967826B2 (en) | 2011-06-28 |
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| Date | Code | Title | Description |
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| FZDE | Discontinued |