USRE39035E1 - Universal coupler for spinal fixation - Google Patents
Universal coupler for spinal fixation Download PDFInfo
- Publication number
- USRE39035E1 USRE39035E1 US08/988,331 US98833197A USRE39035E US RE39035 E1 USRE39035 E1 US RE39035E1 US 98833197 A US98833197 A US 98833197A US RE39035 E USRE39035 E US RE39035E
- Authority
- US
- United States
- Prior art keywords
- coupler
- opening
- openings
- spinal rod
- bore
- 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.)
- Expired - Lifetime
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Classifications
-
- 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
- A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
-
- 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
- A61B17/7041—Screws or hooks combined with longitudinal elements which do not contact vertebrae with single longitudinal rod offset laterally from single row of screws or hooks
Definitions
- the present invention relates to spinal fixation devices, and more particularly, relates to an improved spinal fixation connector that allows for adjustment in four axes of movement when attaching a longitudinal rod to a vertebrae of a spinal column.
- bone screws or bolts are employed in the fixation of the spine wherein the bone screws or bolts are implanted in a surgical procedure involving the formation of one or more surgical openings in adjacent portions of the spine, for implanting the threaded bone bolts or screws into the vertebrae.
- Structures such as longitudinal rods or plates extend between the various spine members and are connected to the implanted bone bolts or screws with connector devices.
- Connectors for attaching the rods or plates to vertebrae of a spinal column are known in the art.
- current bolt to rod connectors do not allow for adjustability in multiple planes in order to better conform to the anatomical structure of the patient and to eliminate initial stresses on the spinal fixation construct.
- stresses are put on the component parts of existing spinal fixation systems and on the vertebral column, which are not designed to accommodate stresses much higher than those encountered during normal patient activity.
- the connector of the present invention allows the entire strength of the connector to be reserved for stresses encountered during patient activity. This provides a spinal construct for a non-compliant patient with activity limitations that is less likely to fail than one with initial high stresses.
- the “single piece” (4 pieces pre-assembled) connector of the present invention facilitates rapid assembly during implantation of the fixation construct. This reduces operating time, blood loss and complications which makes the present invention more appealing to surgeons who will spend less time assembling and adjusting spinal fixation constructs in the operating room.
- the present invention provides a coupler assembly having four axes of movement for connecting a spinal rod to a vertebrae of a patient with a bone bolt or bone screw.
- the coupler assembly includes a tubular coupler member having a longitudinal bore surrounded by a wall.
- the bore has a central axis and first and second end portions with one end being open and internally threaded and the other end portion being closed.
- a plurality of openings are formed through the wall of the tubular coupler member with each of the openings communicating with the bore.
- the plurality of openings include a first pair of openings aligned along a first line that intersects the central axis of the bore at generally right angles, and a second pair of openings aligned along a second line that intersects the central axis of the bore at generally right angles.
- the first and second pairs of openings are generally perpendicular to each other and are spaced apart so that the periphery of the first pair of openings is spaced longitudinally from the periphery of the second pair of openings.
- the first pair of openings is sized and shaped to receive a spinal rod with the spinal rod's longitudinal axis aligning with the first line of the first pair of openings of the coupler body.
- the coupler assembly also includes an eyebolt having a shank portion with a central axis and an eye portion.
- the shank portion is insertable through the second pair of openings of the coupler body, with the central axis of the shank aligning with the second line of the second pair of openings.
- the eye portion of the eyebolt has an opening sized and shaped to mate with a selected bone bolt or bone screw.
- An insert having an outer surface that generally conforms to the shape of the bore, fits within the bore.
- the insert has opposed, arc-shaped end portions with recesses for engaging the spinal rod on one end and the eyebolt on the other end.
- a set screw threadably engages the internally threaded end portion of the bore so that the set screw tightens the assembly of the rod, insert, and eyebolt within the coupler member when tightened down.
- the coupler assembly of the present invention provides for movement along four axes that includes a cephalad/caudad direction, a medial/lateral direction, a sagittal plane and transverse plane when the assembly is being implanted in a patient.
- FIG. 1 is a posterior view of a portion of a vertebral column, showing a spinal fixation device connected to the vertebrae by connectors embodying the present invention
- FIG. 2 is a partial cross-sectional view taken along sight line 2 — 2 in FIG. 1 , illustrating the manor in which the apparatus of the present invention connect the spinal rods to a vertebrae;
- FIG. 3 is a perspective view of the preferred embodiment of the apparatus of the present invention with a spinal rod and bone screw inserted in the apparatus;
- FIG. 4 is an exploded perspective view of the preferred embodiment of the apparatus of the present invention.
- FIG. 4A is a side plan view of an alternate bone fastener
- FIG. 5A is a side perspective view of the coupler member or the present invention.
- FIG. 5B is a cross-sectional view taken along sight line 5 B— 5 B in FIG. 5A ;
- FIG. 5C is a cross-sectional view taken along sight line 5 C— 5 C in FIG. 5A ;
- FIG. 5D is a side plan view of the coupler member of the present invention.
- FIG. 6A is a side perspective view of the set screw of the apparatus of the present invention.
- FIG. 6B is a cross-sectional view of the set screw in FIG. 6A ;
- FIG. 7A is a side perspective view of the insert of the present invention.
- FIG. 7B is a cross-sectional view taken along sight line 7 B— 7 B in FIG. 7A ;
- FIG. 7C is a cross-sectional view taken along sight line 7 C— 7 C in FIG. 7A ;
- FIG. 8A is a side perspective view of the eyebolt of the present invention.
- FIG. 8B is an end plan view taken along sight line 8 B— 8 B in FIG. 8a ;
- FIG. 8C is a lower plan view of the eyebolt of the present invention.
- FIG. 8D is a cross-sectional view taken along sight line 8 D— 8 D in FIG. 8 A.
- FIGS. 1 and 2 show the preferred embodiment of the coupler assembly of the present invention, designated generally by the numeral 10 implanted in a spinal column.
- Coupler assembly 10 includes a coupler body or member 30 , an eyebolt member 50 , an insert 70 and a set screw 80 , and is used to attach longitudinal rods 12 to a vertebral column 14 comprising a plurality of vertebrae 16 .
- the coupler assembly 10 is shown attached to three vertebrae 16 as part of a spinal implant system that is used to hold and stabilize vertebrae 16 . Although the attachment of only three vertebrae 16 is shown, it should be understood that the number of assemblies 10 used can vary such that any number of vertebrae can be held in place.
- Each of the assemblies 10 is connected to a respective vertebrae 16 by a fastener 18 which may be either a bone bolt ( FIGS. 2 , 3 , 4 ) or a bone screw 18 A (FIG. 4 A).
- the fastener 18 is shown in FIGS. 2 , 3 and 4 as bone bolt 18 having a first threaded end portion 22 for threaded engagement with an opening formed in a pedicle 20 of the vertebrae 16 .
- Bolt 18 includes a shoulder portion 24 which establishes how far the first threaded end portion 22 can extend into the vertebrae 16 and spaces the assembly 10 away from the vertebrae 16 .
- Bolt 18 has a second threaded end portion 26 extending past the pedicle 20 for engaging the eyebolt 50 of the assembly 10 .
- the bone bolt 18 also includes a nut 28 that can be threaded upon the threaded end portion 26 of the bolt 18 to secure eyebolt 50 of assembly 10 against the bolt shoulder 24 .
- Bone screw 18 A includes a first threaded end portion 22 A and a head portion 28 A having a spherically shaped lower portion.
- assembly 10 is placed over the threaded end portion of 26 of the bolt 18 .
- the nut 28 is threaded over the end portion 26 in order to securely fasten the bone bolt 18 to the assembly 10 .
- the longitudinal rod 12 having a longitudinal axis A 1 —A 1 ( FIG. 4 ) is placed through an opening in the assembly 10 and the set screw 80 secures the entire assembly 10 A together ( FIGS. 3 , 4 ).
- the coupler assembly 10 A includes the coupler assembly 10 , the spinal rod 12 and the bone fastener 18 .
- the assembly 10 includes the cylindrical coupler body or member 30 , the eyebolt member 50 , insert 70 , and the set screw 80 that when assembled forms the single piece coupler assembly 10 .
- the coupler body 30 is tubular in shape and has a longitudinal bore 32 surrounded by a wall 34 .
- the bore 32 has a central axis C 1 and a first or top portion 36 and a second or bottom portion 38 .
- the top portion 36 is open-ended and includes internal threading 40 .
- the second or bottom end portion 38 is closed.
- the coupler body 30 also has an upper portion 36 A and a lower portion 38 A.
- the upper portion 36 A of the coupler body 30 has a larger diameter in relation to the lower portion 38 A.
- Coupler body 30 includes at least two through openings.
- coupler body 30 includes a first pair of openings through wall 34 aligned along a first line L 1 —L 1 that intersects the central axis C 1 of bore 32 at generally right angles ( FIGS. 5A , 5 B).
- Coupler body 30 also includes a second pair of openings 44 aligned along a second line L 2 —L 2 that intersects the central axis C 1 of bore 32 at generally right angles ( FIGS. 5A , 5 C).
- Openings 42 and 44 are generally perpendicular to each other and spaced apart from each other such that the periphery of the first pair of openings 42 is spaced longitudinally from the periphery of the second pair of openings 44 as shown in FIGS. 3 , 4 and 5 A.
- openings 42 are placed in the upper portion 36 A of coupler body 30 and openings 44 are placed in the lower portion 38 A of coupler body 30 .
- Openings 42 are sized and shaped to receive the spinal rod 12 with the longitudinal axis A 1 of the rod 12 aligning with the line L 1 —L 1 of the openings 42 when the rod 12 is placed through openings 42 of coupler body 30 (FIG. 3 ). Openings 44 have a lower wall portion 46 which is concave in shape in order to accommodate the cylindrical shank portion of the eyebolt 50 (FIG. 5 B).
- a pair of notches 48 are positioned on the outside surface of wall 34 at the open-ended portion 36 of coupler body 30 ( FIGS. 5A , 5 D).
- the notches 48 are sized and shaped to accommodate a tool such as a wrench which is used to stabilize the coupler body 30 while the set screw 80 is being tightened into place.
- Eyebolt member 50 includes a shank portion 52 and an eye portion 54 (FIG. 8 A).
- Shank portion 52 has a central axis C 2 —C 2 and an outer surface 56 (FIG. 8 C).
- shank portion 52 is cylindrical in shape with knurling 58 on a portion of the outer surface 56 ( FIGS. 8A , 8 C).
- Shank portion 52 includes a shank end 64 with a recess 66 so as to allow slight flanging of shank end 64 after the shank portion 52 is inserted through openings 44 of coupler body 30 ( FIGS. 8B , 8 D). The flanging prevents the shank portion 52 from sliding out of the openings 44 after the coupler assembly 10 has been assembled.
- shank portion 52 of eyebolt 50 When shank portion 52 of eyebolt 50 is inserted through openings 44 of coupler body 30 , the shank portion's 52 central axis C 2 —C 2 is aligned along line L 2 —L 2 of openings 44 (FIG. 3 ).
- Eye portion 54 of eyebolt 50 includes an opening 60 , an upper surface 61 , and a lower surface 62 .
- Opening 60 has a spherically shaped surface 63 on the upper and lower surfaces 61 , 62 of eye portion 54 and is sized and shaped to mate with the fastener 18 .
- the spherically shaped nut 28 mates with the spherically shaped surface 63 on the upper surface 61 of the eye portion opening 60 and the spherically shaped shoulder portion 24 mates with the spherically shaped surface 63 on the lower surface 62 of the eye portion opening 60 .
- the bone screw 18 A is used as the bone fastener instead, the spherically shaped surface of the bone screw head portion 28 A mates with the spherically shaped surface 63 on the upper surface 61 of the eye portion opening.
- Insert 70 is cylindrical in shape and has opposed arc-shaped end portions 72 , 76 (FIG. 7 A).
- First end portion 72 has a recess 74 that is sized and shaped to engage the spinal rod 12 ( FIGS. 7A , 7 B).
- Second end portion 76 has a recess 78 sized and shaped to engage the shank portion 52 of eyebolt 50 ( FIGS. 7A , 7 C).
- Insert 70 has an outer surface 71 that generally conforms to the shape of bore 32 of coupler body 30 .
- insert 70 is placed in bore 32 after the shank portion 52 of eyebolt 50 has been placed through openings 44 of coupler body 30 .
- Insert 70 is placed in bore 32 such that recess 78 contacts the outer surface 56 of shank portion 52 of eyebolt 50 .
- recess 74 of insert 70 contacts the surface of the spinal rod 12 .
- insert 70 provides greater surface to surface contact between the rod 12 and shank portion 72 then would be possible if the coupler assembly 10 was used without insert 70 .
- Set screw 80 has an upper surface 82 , a lower surface 84 , and a threaded body portion 86 that engages and cooperates with the internally threaded end portion 36 of coupler body 30 .
- Upper surface 82 is generally flat with a tool receptive socket 88 sized and shaped for receiving a tool designed to thread and tighten the set screw 80 into the threaded portion 40 of bore 32 of coupler body 30 .
- lower surface 84 has a smooth outer surface and is generally conical in shape.
- the set screw 80 provides means for tightening the rod 12 , insert 70 , and eyebolt 50 within the coupler body 30 .
- the coupler body can include a U-shaped top opening, sized and shaped to receive the spinal rod 12 , instead of the pair of openings 42 .
- a cap or a cross-bar with at least one set screw can be used to tighten the assembly 10 together instead of the set screw 80 .
- Coupler assembly 10 is assembled by placing shank portion 52 of eyebolt 50 through openings 44 of coupler body 30 .
- Insert 70 is inserted in the bore 32 so as to allow recess 78 to engage the outer surface of shank portion 52 .
- Set screw 80 is partially threaded into bore 32 which provides the single piece assembly 10 as shown in FIG. 3 .
- the fastener 18 has been implanted in pedicle 20 of vertebrae 16
- the threaded end 26 of bone bolt 18 is inserted through the eyebolt opening 60 of coupler assembly 10 .
- Spinal rod 12 is inserted through openings 42 such that the spinal rod 12 engages recess 74 of insert 70 .
- set screw 80 is tightened into bore 32 of coupler body 30 , securing the entire assembly 10 A in place in the selected position.
- the coupler assembly 10 allows for adjustment along four degrees of freedom, as shown in FIG. 3 .
- Assembly 10 allows for movement along the longitudinal axis A 1 —A 1 of spinal rod 12 which provides adjustment in a cephalad-caudad direction CC—CC.
- Eyebolt 50 can be moved in the openings 44 along the central axis C 2 of shank portion 50 allowing for adjustment in a medial-lateral direction ML—ML.
- the rotation of the spinal rod 12 around its longitudinal axis A 1 —A 1 in the openings 42 allows for angulation in a transverse plane TA—TA.
- the rotation of the eyebolt 50 around its central axis C 2 —C 2 in openings 44 allows for angulation in a sagittal plane SA—SA.
- the present invention provides a “single piece” connector for attaching a spinal rod to a vertebrae that facilitates rapid assembly and allows a wide range of adjustability in four axes of movement.
- the coupler assembly 10 is formed of a biocompatible material, and in a preferred embodiment, is formed of stainless steel.
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Neurology (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Prostheses (AREA)
Abstract
Description
Claims (47)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/988,331 USRE39035E1 (en) | 1994-11-18 | 1997-12-11 | Universal coupler for spinal fixation |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/342,226 US5474551A (en) | 1994-11-18 | 1994-11-18 | Universal coupler for spinal fixation |
US08/988,331 USRE39035E1 (en) | 1994-11-18 | 1997-12-11 | Universal coupler for spinal fixation |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/342,226 Reissue US5474551A (en) | 1994-11-18 | 1994-11-18 | Universal coupler for spinal fixation |
Publications (1)
Publication Number | Publication Date |
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USRE39035E1 true USRE39035E1 (en) | 2006-03-21 |
Family
ID=23340910
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/342,226 Ceased US5474551A (en) | 1994-11-18 | 1994-11-18 | Universal coupler for spinal fixation |
US08/988,331 Expired - Lifetime USRE39035E1 (en) | 1994-11-18 | 1997-12-11 | Universal coupler for spinal fixation |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/342,226 Ceased US5474551A (en) | 1994-11-18 | 1994-11-18 | Universal coupler for spinal fixation |
Country Status (1)
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US (2) | US5474551A (en) |
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