System for stabilizing the vertebral column including deployment instruments and variable expansion inserts therefore

• US 6,905,512 B2
• Filed: 06/17/2002
• Issued: 06/14/2005
• Est. Priority Date: 12/14/1998
• Status: Expired due to Fees

• Current Assignee: Phoenix Biomedical Corporation
• Original Assignee: Phoenix Biomedical Corporation
• Inventors: Paes, Vera, Paes, Newton
• Primary Examiner(s): Pellegrino, Brian E
• Application Number:
  US10/174,362
• Publication Number:
  US 20020151977A1
• Time in Patent Office: 1,093 Days
• Field of Search: 623/17.11, 623/17.16, 606/61
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/8615 at the central region of the screw head
• CPC Class Codes: A61B 17/888 the driver bit acting on the central region of the screw head
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4637 for connecting or disconnecting two parts of a prosthesis
• CPC Class Codes: A61F 2002/30154 square
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30408 Conical threadings
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30538 for adjusting angular orientation
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/30706 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30795 : Blind bores, e.g. of circular cross-section
• CPC Class Codes: A61F 2002/30797 : internally-threaded
• CPC Class Codes: A61F 2002/30858 : Threads interrupted by grooves or sidewalls, e.g. flat sidewalls
• CPC Class Codes: A61F 2002/30863 : the entry end surface having flutes, relief grooves, starter notches or bevelled indentations
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4638 : Tools for performing screwing, e.g. nut or screwdrivers, or particular adaptations therefor
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0021 : square
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/0082 : specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61F 2250/0097 : Visible markings, e.g. indicia
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: Y10S 623/908 : Bone

Abstract

A system is provided for stabilizing adjacent vertebra without excision of bone or resection of ligaments comprising an expansion device and a deployment system which includes a hollow expandable insert and an expansion insert. The expandable insert includes a cylindrical body having a pair of slots having a threaded outer surface. The expandable insert is located with the slots oriented perpendicular to the vertebral column between the vertebrae. The thread cuts into the cortical bone contiguous to the intervertebral space but not substantially into the cancellous bone. The expandable insert is internally threaded. The expansion insert is externally threaded and arranged to be screwed into a bore in the expandable insert by the deployment system, whereupon the slots open to spread the vertebrae apart. The deployment system includes a tool having projecting fingers located within the slots to enable the expandable insert to be screwed into the intervertebral space.

Claims

1. A system for stabilizing a superior vertebra and immediately adjacent inferior vertebra of the vertebral column of a living being without requiring the excision of bone from the superior or inferior vertebrae or the resection of the adjacent longitudinal proximal or distal ligaments, said system comprising a variable expansion device and a deployment system, said variable expansion device comprising a hollow one-piece expandable insert and an expansion insert, said expandable insert comprising a one-piece cylindrical body having a longitudinal axis and a proximal end portion and a distal end portion, said proximal end portion having a pair of slots extending therethrough generally parallel to the longitudinal axis of the expandable insert, said slots forming two cantilevered body portions of said cylindrical body, said slots extending partially into said distal end portion, said distal end portion and at least a portion of said proximal end portion of said expandable insert having an outer surface about which an external helical self-tapping thread extends, said distal end portion and said at least a portion of said proximal end portion of said expandable insert being of a sufficient size to be screwed into the intervertebral space between the superior and inferior vertebrae by said deployment instrument, whereupon said expandable insert is located at a desired depth within the intervertebral space with said slots oriented in a plane generally perpendicular to the portion of the longitudinal axis of the being'"'"'s vertebral column between the superior and inferior vertebrae, said self-tapping thread being of a sufficient height to cut into the cortical bone of the superior and inferior vertebrae contiguous to the intervertebral space but not substantially into the cancellous bone thereof such that said outer surface of said expandable insert about which said external thread extends does not substantially displace any cortical bone, said proximal end portion of said expandable insert having an internally threaded bore extending therethrough and into at least a portion of said distal end portion, said internally threaded bore communicating with said slots said expansion insert having an externally threaded outer surface and being arranged to be screwed into said bore in said proximal end portion of said expandable insert by said deployment system, said expansion insert having an outer diameter adapted to cause said cantilevered body portions to deflect outwardly when said expandable insert is in said desired depth, whereupon said slots open to spread the superior and inferior vertebrae apart, thereby stabilizing the being'"'"'s vertebral column, said deployment system comprising a tool which includes a pair of projecting fingers arranged to be located within respective ones of said slots to enable said expandable insert to be screwed into the intervertebral space to said desired depth.

2. The system of claim 1 wherein said tool includes indicia thereon for indicating when said expandable insert is in said desired depth within the intervertebral space.

3. The system of claim 1 wherein said fingers are arranged to be located in said slots when said expandable insert is in said desired depth to immobilize said expandable insert while said expansion insert is screwed into said bore in said expandable insert.

4. The system of claim 1 wherein said tool includes an elongated hollow distal end portion from which said arms project.

5. The system of claim 1 wherein said deployment system comprises a driver tool and wherein said expansion insert includes a proximal end having a first portion arranged to be engaged by said driver tool for screwing said expansion insert into said bore of said expandable insert.

6. The system of claim 5 wherein said first portion comprises a slot.

7. A system for stabilizing a superior vertebra and immediately adjacent inferior vertebra of the vertebral column of a living being without requiring the excision of bone from the superior or inferior vertebrae or the resection of the adjacent longitudinal proximal or distal ligaments, said system comprising a variable expansion device and a deployment system, said variable expansion device comprising a one-piece hollow expandable insert and an expansion insert, said expandable insert comprising a one-piece cylindrical body having a longitudinal axis and a proximal end portion and a distal end portion, said proximal end portion having a pair of slots extending therethrough generally parallel to the longitudinal axis of the expandable insert, said slots forming two cantilevered body portions of said cylindrical body, said slots extending partially into said distal end portion, said distal end portion and at least a portion of said proximal end portion of said expandable insert having an outer surface about which an external helical self-tapping thread extends, said distal end portion and said at least a portion of said proximal end portion of said expandable insert being of a sufficient size to be screwed into the intervertebral space between the superior and inferior vertebrae by said deployment instrument, whereupon said expandable insert is located at a desired depth within the intervertebral space with said slots oriented in a plane generally perpendicular to the portion of the longitudinal axis of the being'"'"'s vertebral column between the superior and inferior vertebrae, said self-tapping thread being of a sufficient height to cut into the cortical bone of the superior and inferior vertebrae contiguous to the intervertebral space but not substantially into the cancellous bone thereof such that said outer surface of said expandable insert about which said external helical thread extends does not substantially displace any cortical bone, said proximal end portion of said expandable insert having an internally threaded bore extending therethrough and into at least a portion of said distal end portion, said internally threaded bore communicating with said slots, said expansion insert having an externally threaded outer surface and being arranged to be screwed into said bore in said proximal end portion of said expandable insert by said deployment system, said expansion insert having an outer diameter adapted to cause said cantilevered body portions to deflect outwardly when said expandable insert is in said desired depth, whereupon said slots open to spread the superior and inferior vertebrae apart, thereby stabilizing the being'"'"'s vertebral column, wherein said deployment system is arranged to immobilize said expandable insert at said desired depth when said expansion insert is screwed into said bore and wherein said deployment system comprises a driver tool and wherein said expansion insert includes a proximal end having a first portion arranged to be engaged by said driver tool.

8. The system of claim 7 wherein said deployment system comprises a first tool having an elongated hollow distal end portion from which a pair of fingers project, said projecting fingers being arranged to be located within respective ones of said slots to enable said expandable insert to be screwed into the intervertebral space to said desired depth and for holding said expandable insert immobilized at said desired depth, said driver tool being arranged for location within said hollow distal end portion of said first tool for screwing said expansion insert into said bore of said expandable insert when said expandable insert is immobilized at said desired depth.