US20060149245A1 - Bone fixation system - Google Patents

Bone fixation system Download PDF

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Publication number
US20060149245A1
US20060149245A1 US11/349,763 US34976306A US2006149245A1 US 20060149245 A1 US20060149245 A1 US 20060149245A1 US 34976306 A US34976306 A US 34976306A US 2006149245 A1 US2006149245 A1 US 2006149245A1
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United States
Prior art keywords
bone
bone screw
screw
drill
passage
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US11/349,763
Inventor
Patrick Sweeney
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Spinal Generations LLC
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Spinal Generations LLC
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Publication date
Priority claimed from US10/864,673 external-priority patent/US7938848B2/en
Application filed by Spinal Generations LLC filed Critical Spinal Generations LLC
Priority to US11/349,763 priority Critical patent/US20060149245A1/en
Assigned to SPINAL GENERATIONS, LLC reassignment SPINAL GENERATIONS, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SWEENEY, PATRICK J.
Publication of US20060149245A1 publication Critical patent/US20060149245A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • AHUMAN NECESSITIES
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    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7004Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7005Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit in the screw or hook heads
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7004Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • A61B17/7007Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
    • AHUMAN NECESSITIES
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    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/701Longitudinal elements with a non-circular, e.g. rectangular, cross-section
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    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • AHUMAN NECESSITIES
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    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037Screws 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
    • AHUMAN NECESSITIES
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    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/704Screws 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
    • AHUMAN NECESSITIES
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    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7041Screws or hooks combined with longitudinal elements which do not contact vertebrae with single longitudinal rod offset laterally from single row of screws or hooks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8033Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
    • A61B17/8047Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers wherein the additional element surrounds the screw head in the plate hole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7011Longitudinal element being non-straight, e.g. curved, angled or branched
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8625Shanks, i.e. parts contacting bone tissue
    • A61B17/863Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8685Pins or screws or threaded wires; nuts therefor comprising multiple separate parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30907Nets or sleeves applied to surface of prostheses or in cement
    • A61F2002/30909Nets

Definitions

  • the present invention relates to instrumentation and methods used in the installation of bone screws, alone or in combination with other implantable orthopedic devices.
  • the present invention relates to a bone fixation system and related surgical methods.
  • the bones of the human skeletal system may be compromised in various ways, including by disease or defect, such as a tumor, or an injury, such as a bone fracture.
  • disease or defect such as a tumor
  • an injury such as a bone fracture.
  • the resulting defects or abnormalities in the skeletal system often require treatment to ensure proper functioning of the skeletal system and the avoidance of undue pain and discomfort.
  • bone fixation devices such as bone screws
  • bone screws used alone or in combination with other implantable orthopedic devices.
  • one or more bone screws may be employed to treat a bone fracture by stabilizing various bone pieces together and providing support during the healing process.
  • Bone screws may also be used to fuse bones that are otherwise normally separate by screwing directly through one bone into a second bone.
  • bone screws used in combination with other implantable devices, bone screws may be used to secure a fixation device directly or indirectly onto bone fracture pieces or separate bones intended to be fused.
  • bone screws are installed by performing one or more of a number of steps.
  • a pilot hole to receive the bone screw may need to be drilled and tapped to accommodate the appropriate screw thread type.
  • a guide wire is often installed along the desired insertion path of the bone screw. The bone screw is screwed over the guide wire into place using a driver, and the guide wire is subsequently removed.
  • the insertion of the bone screw may or may not additionally involve the securing of some type of fixation device to the bone material, either directly to the surface of the bone or though attachment to one or more exposed portions of bone screws.
  • One challenge associated with the use of bone screws in bone fixation procedures is the number of steps involved in the process. As discussed above, certain procedures may involve, for each bone screw, drilling a hole, tapping the hole, inserting a guide wire into the hole, driving a bone screw over the guide wire, and removing the guide wire. Ideally, the number of steps involved in the process should be minimized to reduce the overall time of the surgical procedure.
  • a bone fixation system should also be configured for use with a minimally invasive surgical approach, such as one that utilizes smaller access apertures or ports rather than a large incision along the entire portion of the bone or bones being treated.
  • An additional challenge is minimizing the number of sharp or pointed objects that remain within a fixated region of a patient after surgery. Such sharp or pointed objects may contribute to producing undesirable conditions related to bone structure or bone function. Ideally, the number of sharp or pointed objects remaining within fixated bone regions of patients after surgery should be minimized.
  • the invention relates to a bone fixation system having a bone screw with a longitudinal axis and a passage in the bone screw extending along the longitudinal axis, the passage having a proximal opening at a proximal end of the screw and a distal opening at a distal end of the screw.
  • a drill extends through the passage, a first end of the drill extending out the distal opening, whereby the combination of the bone screw and the drill is self-drilling.
  • the invention further relates to a bone fixation instrumentation kit having a bone screw with a passage extending along a longitudinal axis, the passage having a proximal opening at a proximal end of the screw and a distal opening at a distal end of the screw.
  • the kit further contains a driver adapted to extend through the passage, whereby the combination of the bone screw and the driver is self-drilling.
  • the invention further relates to a method for connecting a bone screw to a bone.
  • the method includes the steps of opening an aperture in a patient to permit access to a bone, providing a bone screw having a passage extending along a longitudinal axis of the screw, the passage having a keyed portion, a proximal opening at a proximal end of the screw, and a distal opening at a distal end of the screw.
  • the method further includes the steps of providing a drill having a shaft, a cutting tip, and a keyed segment configured to interlock with the keyed portion, inserting the drill into the passage such that the cutting tip protrudes from the distal opening and the keyed segment interlocks with the keyed portion, and rotating the drill and screw to simultaneously drill a pilot hole and screw the bone screw into the bone.
  • the method further includes the step of removing the drill from the bone screw without also removing the bone screw from the bone.
  • the invention further relates to a method for attaching a bone screw to a plurality of bone segments.
  • the method includes opening an aperture in a patient to permit access to a first bone segment and a second bone segment, providing a bone screw having a passage extending along a longitudinal axis of the bone screw, the passage having a proximal opening at a proximal end of the bone screw and a distal opening at a distal end of the bone screw, providing a driver, inserting the driver into the passage, driving the screw into and through the first bone segment and onto the second bone segment, and removing the driver from the passage without removing the bone screw from the first and second bone segments.
  • FIG. 1 is a perspective view of a bone fixation system
  • FIG. 2 is a perspective view of the bone fixation system of FIG. 1 assembled for use
  • FIG. 3 is a sectional view of the bone fixation system of FIG. 2 ;
  • FIG. 4 is a perspective view of the bone fixation system of FIG. 2 positioned for use on a spine;
  • FIG. 5 is a perspective view of the bone fixation system of FIG. 2 after connection of the bone screw to the spine;
  • FIG. 6 is a perspective view of a bone fixation system assembly connected to a spine
  • FIG. 7 is a perspective view of a bone fixation system
  • FIG. 8 is an exploded perspective view of the bone fixation system of FIG. 7 ;
  • FIG. 9 is a sectional view of the bone fixation system of FIG. 7 viewed along line 1 - 1 ;
  • FIG. 10 is a perspective view of the bone fixation system of FIG. 7 connected to a spine;
  • FIG. 11 is a perspective view of a bone fixation system positioned for use on the first and second cervical vertebrae;
  • FIG. 12 is a perspective view of the bone fixation system of FIG. 11 after insertion of the bone screw;
  • FIG. 13 is a perspective view of a bone fixation system positioned for use in a trans-articular suffusion
  • FIG. 14 is a perspective view of the bone fixation system of FIG. 13 after insertion of the bone screw;
  • FIG. 15 is a perspective view of a bone fixation system positioned for use in a trans-articular suffusion
  • FIG. 16 is a perspective view of the bone fixation system of FIG. 15 after insertion of the bone screw;
  • FIG. 17 is a perspective view of the bone fixation system of FIG. 15 after insertion of a second bone screw;
  • FIG. 18 is a perspective view of a bone fixation system positioned for use on a fractured odontoid process
  • FIG. 19 is a perspective view of the bone fixation system of FIG. 18 after insertion of the bone screw;
  • FIG. 20 is a perspective view of the bone fixation system of FIG. 18 after insertion of a second bone screw;
  • FIG. 21 is a perspective view of a bone fixation system positioned for use on a fractured clavicle bone
  • FIG. 22 is a perspective view of the bone fixation system of FIG. 21 after insertion of the bone screw;
  • FIG. 23 is a perspective view of a bone fixation system positioned for use on a fifth metatarsal bone.
  • FIG. 24 is a sectional view of the bone fixation system of FIG. 23 after insertion of the bone screw.
  • a bone fixation system includes a bone anchoring element or bone screw 10 .
  • Bone screw 10 may be used in conjunction with a driver, shown as drill 28 , and holding device 24 .
  • Bone screw 10 includes a threaded portion 14 and a non-threaded upper portion, shown as post 18 .
  • a tip 12 is located at one end of bone screw 10 and a shoulder or flange 16 extends from the screw 10 between the post 18 and threaded portion 14 .
  • an engagement mechanism for a screwdriver or drill shown as recess 20 , may be utilized.
  • Drill 28 includes a shaft 30 sized to fit within a passage 22 (see FIG. 3 ), a portion having cutting edges 32 , and a drill tip 34 .
  • the bone screws 10 shown in various embodiments of the invention are cannulated to include passage 22 to accommodate drills such as drill 28 . Accordingly, the drill 28 may function as a drill and as a driver for turning the screw.
  • One advantage of the presently described embodiment of the invention is that the combination of drill 28 and bone screw 10 is self-drilling, yet upon removal of the drill 28 , no snap or pointed objects remain within the patent.
  • the term “driver” is intended to generically refer to a drill or turning tool or a tool having both functions.
  • a keyed segment 36 of the drill is shaped to lock into recess 20 so that when the drill 28 is rotated, the bone screw 10 is also rotated.
  • An expanded segment 38 is sized to rest upon the top of post 18 , and has an outer diameter that is the same as that of post 18 in a preferred embodiment.
  • An upper keyed segment 40 provides an interface for a drill or other turning tool used to turn the drill 28 and the bone screw 10 .
  • a holding device 24 is shown as having a cylindrical shape.
  • An attachment mechanism shown as a number of prongs 26 , extends from the bottom of the holding device 24 and is intended to snap over the ridge 16 to connect the holding device 24 to the bone screw 10 .
  • the top of the holding device 24 may be shaped to engage expanded segment 38 to lock the drill 28 into place in the bone screw 10 .
  • the bone screw 10 , drill 28 , and holding device 24 create an efficient self-drilling tool for drilling the bone screw into a selected portion of bone.
  • the drill tip 34 extends from the distal opening of the passage in the bone screw at the bone screw tip 12 to aid in the insertion of the bone screw 10 .
  • the smaller diameter cutting edges 32 and sharp cutting tip 34 may be desired by a surgeon when inserting the bone screw 10 to provide a more accurate placement and initial drilling point for the bone screw 10 , eliminating the necessity of first drilling a pilot hole and utilizing a guide wire to guide the bone screw. Inserting a separate guide wire with a separate drill bit requires additional steps in the surgery and additional components, complicating and perhaps lengthening the overall surgery.
  • the holding device 24 aids in the manipulation of the bone screw 10 and drill 28 by preventing the drill 28 from disengaging from the bone screw 10 during the insertion process.
  • the drill 28 and holding device 24 may be assembled together with the bone screw 10 prior to connecting the bone screw 10 to the bone and may be assembled by sliding the components together and snapping the holding device 24 onto the bone screw 10 without having to screw various components together.
  • bone screw 10 is shown as a cannulated screw, having passage 22 extending the length of bone screw 10 .
  • bone screw 10 may also be fenestrated, having a series of holes extending radially outward from recess 22 along the length of bone screw 10 .
  • the fenestrated design allows delivery of fluids, such as bone morphogenic proteins or high dose antibiotics, to be delivered through bone screw 10 after installation directly to the fixation site to assist in the fixation process.
  • the assembled device depicted in FIG. 2 may be utilized to drill the bone screw 10 into a chosen bone or bones, shown as the spine, utilizing the drill 28 in combination with the bone screw 10 .
  • the drill tip 34 aids in selecting a precise location for drilling the hole for the bone screw 10 .
  • the holding device 24 may be removed from the bone screw 10 by disengaging the prongs 26 , which in a preferred embodiment may be disengaged by pulling the holding device 24 away from the bone screw 10 .
  • the drill 28 remains. In a preferred embodiment, the drill may be removed from the bone screw 10 by pulling the keyed segment 36 out of the recess 20 . However, the user may elect to leave the drill 28 in place (or replace the drill 28 with another driver configured to be inserted into the passage 22 ) during assembly of a coupling mechanism as described below.
  • the bone screw 10 may be coupled to a fixation element or linking device, shown as fixation plate 42 , via a coupling mechanism 44 .
  • fixation plate 42 a fixation element or linking device
  • the bone screw 10 may be inserted into a bone and linked to other bone screws by the fixation plate 42 .
  • the length of the fixation plate 42 is chosen to accommodate the total distance between the bone screws that are linked together.
  • a receiver 46 includes a pair of wall portions 48 that together form a U-shaped receiver sized to receive fixation plate 42 .
  • the internal side of wall portions 48 may be threaded to engage with other instrumentation.
  • the wall portions 48 extend upwardly from base 50 .
  • collar 52 has a threaded interior portion and a shoulder 54 that is sized to rest upon base 50 .
  • a collet 56 includes a number of compressible arms 58 intended to engage with bone screw 10 upon assembly.
  • a lower set screw 60 has a head 62 that may be configured to be grasped by a tool, such as the hex-head configuration shown in FIG. 8 .
  • a threaded portion 64 is configured to engage with the internal threads of the collar 52 during assembly.
  • a pair of retaining rings 66 , 68 engage either side of fixation plate 42 , the lower retaining ring 66 resting upon collar 52 and the upper retaining ring 68 compressed between the fixation plate 42 and an upper set screw 70 .
  • the upper set screw 70 has a threaded portion 72 intended to engage with the threaded interior side of wall portions 48 of the receiver 46 upon assembly.
  • the upper set screw 70 may have a head configuration designed to be engaged by a wrench or other tightening tool.
  • each of the components forming the coupling mechanism has an interior channel or aperture configured to allow the components to be placed upon and encircle the post 18 .
  • the collet 56 is placed into collar 52 , the outer diameter of the collet 56 being greater along a portion of the longitudinal axis of collet 56 than the interior diameter of collar 52 , as shown in FIG. 8 .
  • the lower set screw 60 may then be threaded into collar 52 , thus engaging collet 56 and pushing collet 56 downward through the collar 52 until the compressible arms 58 are forced to grip and be secured to post 18 . Engagement of the post 18 by the collet 56 locks the collet 56 and the other components of the coupling mechanism into place relative to the bone screw 10 for fixation to the fixation plate 42 .
  • the collet 56 may be locked onto post 18 at any position along the longitudinal axis of post 18 , affording flexibility in the placement of the coupling mechanism components.
  • the collet may engage with the threaded portion of the bone screw.
  • the flexibility in placement of the collet is important due to the variability in placement of the bone screw 10 depending on the anatomy of the patient.
  • the recess 20 extends into the bone screw 10 to create a keyed portion of passage 22 that extends the length of the bone screw 10 .
  • the keyed portion may serve as an engagement point for a driver as discussed above.
  • FIG. 10 the embodiment of the bone fixation system shown in FIGS. 7-9 is shown installed into a patient's spine.
  • the bone screws 10 may be individually installed prior to the installation of the fixation plate 42 across the multiple bone screws 10 .
  • the fixation device or plate 42 as shown is configured to be attached from the top of and after installation of bone screws 10 .
  • a fixation plate with multiple though-holes may be configured to be applied directly to one or more bones or bone fragments to be fused together prior to the installation of bone screw 10 .
  • the through holes are configured to allow bone screw 10 to secure the fixation plate 42 to the bone.
  • a single aperture in the fixation plate may be provided and configured to accept multiple bone screws 10 . After locating the fixation plate across the fracture site or joint, bone screws 10 may be driven though the through-holes and into the bone on both sides of the fracture site or joint, thereby securing the fixation plate 42 to the pieces of bone to be joined.
  • the various bone fixation or instrumentation systems described herein as exemplary embodiments of the invention may be utilized in the performance of bone fixation procedures using a streamlined method that is intended to simplify and shorten conventional bone fixation procedures.
  • imaging of the patient may be utilized to determine the number and locations of bone screws that will be required as part of the procedure.
  • an image guidance system may be utilized as part of the procedure to aid in the placement of the various components.
  • an entry site is created in the patient along the portion of the bone into which the bone screws will be inserted.
  • individual entry ports may be utilized for implantation of individual bone screws.
  • Certain embodiments of the invention described herein are particularly suited to a minimally invasive approach because the coupling components are placed upon the screw from the top, allowing insertion and connection of the components via the small percutaneous aperture created for the screw itself in contrast to other designs requiring the use of coupling components that are not in line with the longitudinal axis of the screw, which may require an open procedure.
  • the drill may be inserted into the bone screw, using the holding device to hold the drill in place, if desired, and utilized to drill into the bone simultaneously with the bone screw.
  • FIGS. 11-24 show various other embodiments of the invention as applied to various portions of the skeletal system.
  • the bone screw 10 and associated drill 28 are used in a posterior trans-articular fixation procedure of the first (C1) and second (C2) cervical vertebrae 74 , 76 .
  • An entry site is created posterior the C2 vertebra 76 and an insertion point on the surface of the C2 vertebra 76 is determined.
  • the drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point through the C2 vertebra 76 and into the C1 vertebra 74 , thereby fixating the two bones.
  • the drill 28 is then removed from the bone screw 10 located in the fixated region.
  • a second bone screw 10 (not shown) is then inserted in a similar fashion to ensure proper fixation of the bones.
  • the two bone screws 10 are normally offset to opposite sides of the midline of the vertebrae 74 , 76 .
  • the bone screw 10 and associated drill 28 are used in a trans-articular suffusion procedure of the lower lumbar region involving the fourth (L4) and fifth (L5) lumbar vertebrae 78 , 80 .
  • An entry site is created posterior the L4 vertebra 78 and an insertion point on the surface of the L4 vertebra 78 is determined.
  • the drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point through the L4 vertebra 78 and into the L5 vertebra 80 , thereby fixating the two bones.
  • the drill 28 is then removed from the bone screw 10 located in the fixated region.
  • the bone screw 10 and associated drill 28 are used in a lumbosacral fixation procedure involving the fifth lumbar (L5) and first sacral (S1) vertebrae 82 , 84 .
  • An entry site is created posterior the L5 vertebra 82 and a first insertion point on the surface of the L5 vertebra 82 is determined.
  • the drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point through the L5 vertebra 82 and into the S1 vertebra 84 , thereby fixating the two bones.
  • the drill 28 is then removed from the bone screw 10 located in the fixated region.
  • a second bone screw 10 is then inserted in a similar fashion to ensure proper fixation of the bones.
  • the two screws 10 are normally offset to opposite sides of the midline of the vertebrae 82 , 84 .
  • the bone screw 10 and associated drill 28 are used in a fixation procedure of a fracture of the odontoid process 86 of the C2 vertebra 88 .
  • An entry site is created anterior the C2 vertebra 88 and a first insertion point on the surface of the C2 vertebra 88 is determined.
  • the drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point through the C2 vertebra 88 and into the odontoid process 86 , thereby fixating the fracture.
  • the drill 28 is then removed from the bone screw 10 located in the fixated region.
  • a second bone screw 10 may be inserted in a similar fashion through a second insertion point, as shown in FIG. 20 , to ensure proper fixation of the fracture.
  • the two screws 10 are normally offset to opposite sides of the midline of the C2 vertebrae 88 .
  • the bone screw 10 and associated drill 28 are used in an internal fixation procedure of a fractured clavicle 94 .
  • an entry site is chosen to allow insertion of a bone screw 10 , across the fracture site in the longitudinal direction of the clavicle bone.
  • the drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point on the first fractured portion 90 , through the fracture site along the longitudinal direction of the clavicle bone 94 , and into a second fractured portion 92 .
  • the drill 28 is then removed from the bone screw 10 located in the fixated region.
  • the bone screw 10 and associated drill 28 are used in a fixation procedure of the fifth metatarsal 100 .
  • an entry site is chosen to allow insertion of a bone screw 10 across the fracture site in the longitudinal direction of the metatarsal bone 100 .
  • the drill 28 is then inserted into the bone screw 28 and the screw is driven from the insertion point into a first fractured portion 96 , through the fracture site along the longitudinal direction of the metatarsal bone 100 , and into a second fractured portion 98 .
  • the drill 28 is then removed from the bone screw 10 located in the fixated region.
  • a fixation plate is to be installed, a portion of each of the bone screws is left exposed outside of the bone material as shown in FIG. 9 .
  • the coupling mechanism is utilized to connect the bone screws to a linking device, such as a fixation rod or plate as shown and described herein.
  • a linking device such as a fixation rod or plate as shown and described herein.
  • multiple drills may be utilized to aid in the installation of the coupling components and the linking device may be threaded beneath the patient's skin between the various bone screws that are being linked to each other.
  • the fixation plate 42 may be placed directly onto the bone or bones prior to installation of the bone screws 10 . After positioning the fixation plate 42 onto the bone, bone screws 10 are driven through the fixation plate 42 and into the bone, thereby securing the fixation plate 42 directly to the bone.
  • drill 28 is provided with drill tip 34 to make the combination of bone screw 10 and drill 28 self-drilling. It should be noted that after insertion of bone screw 10 , drill 28 may be removed, thereby ensuring that no sharp or pointed objects (e.g., drill tip 34 ) remain within the patent.

Abstract

A bone fixation system includes a bone screw having a longitudinal axis. A passage in the bone screw extends along the longitudinal axis and has a proximal opening at the proximal end of the bone screw and a distal opening at a distal end of the bone screw. A drill extends through the passage, a first end of the drill extending out the distal opening. The combination of the bone screw and the drill is self-drilling.

Description

  • This is a continuation-in-part of application Ser. No. 11/071,604, filed Mar. 3, 2005, which is a continuation-in-part of application Ser. No. 10/864,673, filed Jun. 9, 2004, both of which are incorporated herein by reference herein.
  • FIELD OF THE INVENTION
  • The present invention relates to instrumentation and methods used in the installation of bone screws, alone or in combination with other implantable orthopedic devices. In particular, the present invention relates to a bone fixation system and related surgical methods.
  • BACKGROUND OF THE INVENTION
  • The bones of the human skeletal system may be compromised in various ways, including by disease or defect, such as a tumor, or an injury, such as a bone fracture. The resulting defects or abnormalities in the skeletal system often require treatment to ensure proper functioning of the skeletal system and the avoidance of undue pain and discomfort.
  • Various treatments exist for the treatment of bone fractures and/or bone or skeletal abnormalities. These treatments include, among others, the use of internal bone fixation devices, such as bone screws, used alone or in combination with other implantable orthopedic devices. Used alone, one or more bone screws may be employed to treat a bone fracture by stabilizing various bone pieces together and providing support during the healing process. Bone screws may also be used to fuse bones that are otherwise normally separate by screwing directly through one bone into a second bone. Used in combination with other implantable devices, bone screws may be used to secure a fixation device directly or indirectly onto bone fracture pieces or separate bones intended to be fused.
  • Conventionally, bone screws are installed by performing one or more of a number of steps. First, a pilot hole to receive the bone screw may need to be drilled and tapped to accommodate the appropriate screw thread type. A guide wire is often installed along the desired insertion path of the bone screw. The bone screw is screwed over the guide wire into place using a driver, and the guide wire is subsequently removed. The insertion of the bone screw may or may not additionally involve the securing of some type of fixation device to the bone material, either directly to the surface of the bone or though attachment to one or more exposed portions of bone screws.
  • One challenge associated with the use of bone screws in bone fixation procedures is the number of steps involved in the process. As discussed above, certain procedures may involve, for each bone screw, drilling a hole, tapping the hole, inserting a guide wire into the hole, driving a bone screw over the guide wire, and removing the guide wire. Ideally, the number of steps involved in the process should be minimized to reduce the overall time of the surgical procedure.
  • Ideally, a bone fixation system should also be configured for use with a minimally invasive surgical approach, such as one that utilizes smaller access apertures or ports rather than a large incision along the entire portion of the bone or bones being treated.
  • An additional challenge is minimizing the number of sharp or pointed objects that remain within a fixated region of a patient after surgery. Such sharp or pointed objects may contribute to producing undesirable conditions related to bone structure or bone function. Ideally, the number of sharp or pointed objects remaining within fixated bone regions of patients after surgery should be minimized.
  • There is also a need to be able to deliver fluids directly to the site of a bone fixation procedure. Certain bone fixations heal more slowly than others, and the healing process may be facilitated by the delivery of certain fluids to the fixated region. It is therefore desirable to have a vehicle for easy delivery of fluids to fixated regions of bone.
  • It would be desirable to provide a system and/or method that provides one or more of these or other advantageous features or addresses one or more of the above-identified needs. Other features and advantages will be made apparent from the present specification. The teachings disclosed extend to those embodiments that fall within the scope of the appended claims, regardless of whether they accomplish one or more of the above-identified needs.
  • SUMMARY OF THE INVENTION
  • The invention relates to a bone fixation system having a bone screw with a longitudinal axis and a passage in the bone screw extending along the longitudinal axis, the passage having a proximal opening at a proximal end of the screw and a distal opening at a distal end of the screw. A drill extends through the passage, a first end of the drill extending out the distal opening, whereby the combination of the bone screw and the drill is self-drilling.
  • The invention further relates to a bone fixation instrumentation kit having a bone screw with a passage extending along a longitudinal axis, the passage having a proximal opening at a proximal end of the screw and a distal opening at a distal end of the screw. The kit further contains a driver adapted to extend through the passage, whereby the combination of the bone screw and the driver is self-drilling.
  • The invention further relates to a method for connecting a bone screw to a bone. The method includes the steps of opening an aperture in a patient to permit access to a bone, providing a bone screw having a passage extending along a longitudinal axis of the screw, the passage having a keyed portion, a proximal opening at a proximal end of the screw, and a distal opening at a distal end of the screw. The method further includes the steps of providing a drill having a shaft, a cutting tip, and a keyed segment configured to interlock with the keyed portion, inserting the drill into the passage such that the cutting tip protrudes from the distal opening and the keyed segment interlocks with the keyed portion, and rotating the drill and screw to simultaneously drill a pilot hole and screw the bone screw into the bone. The method further includes the step of removing the drill from the bone screw without also removing the bone screw from the bone.
  • The invention further relates to a method for attaching a bone screw to a plurality of bone segments. The method includes opening an aperture in a patient to permit access to a first bone segment and a second bone segment, providing a bone screw having a passage extending along a longitudinal axis of the bone screw, the passage having a proximal opening at a proximal end of the bone screw and a distal opening at a distal end of the bone screw, providing a driver, inserting the driver into the passage, driving the screw into and through the first bone segment and onto the second bone segment, and removing the driver from the passage without removing the bone screw from the first and second bone segments.
  • The invention is capable of other embodiments and of being practiced or being carried out in various ways. Alternative exemplary embodiments relate to other features and combinations of features as may be generally recited in the claims.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The invention will become more fully understood from the following detailed description, taken in conjunction with the accompanying drawings, wherein like reference numerals refer to like elements, in which:
  • FIG. 1 is a perspective view of a bone fixation system;
  • FIG. 2 is a perspective view of the bone fixation system of FIG. 1 assembled for use;
  • FIG. 3 is a sectional view of the bone fixation system of FIG. 2;
  • FIG. 4 is a perspective view of the bone fixation system of FIG. 2 positioned for use on a spine;
  • FIG. 5 is a perspective view of the bone fixation system of FIG. 2 after connection of the bone screw to the spine;
  • FIG. 6 is a perspective view of a bone fixation system assembly connected to a spine;
  • FIG. 7 is a perspective view of a bone fixation system;
  • FIG. 8 is an exploded perspective view of the bone fixation system of FIG. 7;
  • FIG. 9 is a sectional view of the bone fixation system of FIG. 7 viewed along line 1-1;
  • FIG. 10 is a perspective view of the bone fixation system of FIG. 7 connected to a spine;
  • FIG. 11 is a perspective view of a bone fixation system positioned for use on the first and second cervical vertebrae;
  • FIG. 12 is a perspective view of the bone fixation system of FIG. 11 after insertion of the bone screw;
  • FIG. 13 is a perspective view of a bone fixation system positioned for use in a trans-articular suffusion;
  • FIG. 14 is a perspective view of the bone fixation system of FIG. 13 after insertion of the bone screw;
  • FIG. 15 is a perspective view of a bone fixation system positioned for use in a trans-articular suffusion;
  • FIG. 16 is a perspective view of the bone fixation system of FIG. 15 after insertion of the bone screw;
  • FIG. 17 is a perspective view of the bone fixation system of FIG. 15 after insertion of a second bone screw;
  • FIG. 18 is a perspective view of a bone fixation system positioned for use on a fractured odontoid process;
  • FIG. 19 is a perspective view of the bone fixation system of FIG. 18 after insertion of the bone screw;
  • FIG. 20 is a perspective view of the bone fixation system of FIG. 18 after insertion of a second bone screw;
  • FIG. 21 is a perspective view of a bone fixation system positioned for use on a fractured clavicle bone;
  • FIG. 22 is a perspective view of the bone fixation system of FIG. 21 after insertion of the bone screw;
  • FIG. 23 is a perspective view of a bone fixation system positioned for use on a fifth metatarsal bone; and
  • FIG. 24 is a sectional view of the bone fixation system of FIG. 23 after insertion of the bone screw.
  • DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
  • Referring to FIG. 1, in an exemplary embodiment of the invention, a bone fixation system includes a bone anchoring element or bone screw 10. Bone screw 10 may be used in conjunction with a driver, shown as drill 28, and holding device 24. Bone screw 10 includes a threaded portion 14 and a non-threaded upper portion, shown as post 18. A tip 12 is located at one end of bone screw 10 and a shoulder or flange 16 extends from the screw 10 between the post 18 and threaded portion 14. At the top of the post 18, an engagement mechanism for a screwdriver or drill, shown as recess 20, may be utilized.
  • Drill 28 includes a shaft 30 sized to fit within a passage 22 (see FIG. 3), a portion having cutting edges 32, and a drill tip 34. The bone screws 10 shown in various embodiments of the invention are cannulated to include passage 22 to accommodate drills such as drill 28. Accordingly, the drill 28 may function as a drill and as a driver for turning the screw. One advantage of the presently described embodiment of the invention is that the combination of drill 28 and bone screw 10 is self-drilling, yet upon removal of the drill 28, no snap or pointed objects remain within the patent. The term “driver” is intended to generically refer to a drill or turning tool or a tool having both functions. A keyed segment 36 of the drill is shaped to lock into recess 20 so that when the drill 28 is rotated, the bone screw 10 is also rotated. An expanded segment 38 is sized to rest upon the top of post 18, and has an outer diameter that is the same as that of post 18 in a preferred embodiment. An upper keyed segment 40 provides an interface for a drill or other turning tool used to turn the drill 28 and the bone screw 10.
  • Further referring to FIG. 1, a holding device 24 is shown as having a cylindrical shape. An attachment mechanism, shown as a number of prongs 26, extends from the bottom of the holding device 24 and is intended to snap over the ridge 16 to connect the holding device 24 to the bone screw 10. Referring to FIG. 3, the top of the holding device 24 may be shaped to engage expanded segment 38 to lock the drill 28 into place in the bone screw 10.
  • Referring to FIG. 2, once assembled together, the bone screw 10, drill 28, and holding device 24 create an efficient self-drilling tool for drilling the bone screw into a selected portion of bone. The drill tip 34 extends from the distal opening of the passage in the bone screw at the bone screw tip 12 to aid in the insertion of the bone screw 10. The smaller diameter cutting edges 32 and sharp cutting tip 34 may be desired by a surgeon when inserting the bone screw 10 to provide a more accurate placement and initial drilling point for the bone screw 10, eliminating the necessity of first drilling a pilot hole and utilizing a guide wire to guide the bone screw. Inserting a separate guide wire with a separate drill bit requires additional steps in the surgery and additional components, complicating and perhaps lengthening the overall surgery. The holding device 24 aids in the manipulation of the bone screw 10 and drill 28 by preventing the drill 28 from disengaging from the bone screw 10 during the insertion process.
  • Referring to FIG. 3, the drill 28 and holding device 24 may be assembled together with the bone screw 10 prior to connecting the bone screw 10 to the bone and may be assembled by sliding the components together and snapping the holding device 24 onto the bone screw 10 without having to screw various components together.
  • Further referring to FIG. 3, bone screw 10 is shown as a cannulated screw, having passage 22 extending the length of bone screw 10. In an alternative embodiment (not shown), bone screw 10 may also be fenestrated, having a series of holes extending radially outward from recess 22 along the length of bone screw 10. The fenestrated design allows delivery of fluids, such as bone morphogenic proteins or high dose antibiotics, to be delivered through bone screw 10 after installation directly to the fixation site to assist in the fixation process.
  • Referring to FIG. 4, the assembled device depicted in FIG. 2 may be utilized to drill the bone screw 10 into a chosen bone or bones, shown as the spine, utilizing the drill 28 in combination with the bone screw 10. The drill tip 34 aids in selecting a precise location for drilling the hole for the bone screw 10.
  • Referring to FIG. 5, once the bone screw 10 has been screwed into the bone, the holding device 24 may be removed from the bone screw 10 by disengaging the prongs 26, which in a preferred embodiment may be disengaged by pulling the holding device 24 away from the bone screw 10. Referring to FIG. 6, once the holding device 24 has been removed from the bone screw 10, the drill 28 remains. In a preferred embodiment, the drill may be removed from the bone screw 10 by pulling the keyed segment 36 out of the recess 20. However, the user may elect to leave the drill 28 in place (or replace the drill 28 with another driver configured to be inserted into the passage 22) during assembly of a coupling mechanism as described below.
  • Referring to FIGS. 7-10, the bone screw 10 may be coupled to a fixation element or linking device, shown as fixation plate 42, via a coupling mechanism 44. In use, the bone screw 10 may be inserted into a bone and linked to other bone screws by the fixation plate 42. The length of the fixation plate 42 is chosen to accommodate the total distance between the bone screws that are linked together.
  • Referring to FIG. 8, a receiver 46 includes a pair of wall portions 48 that together form a U-shaped receiver sized to receive fixation plate 42. The internal side of wall portions 48 may be threaded to engage with other instrumentation. The wall portions 48 extend upwardly from base 50.
  • Further referring to FIG. 8, collar 52 has a threaded interior portion and a shoulder 54 that is sized to rest upon base 50. A collet 56 includes a number of compressible arms 58 intended to engage with bone screw 10 upon assembly. A lower set screw 60 has a head 62 that may be configured to be grasped by a tool, such as the hex-head configuration shown in FIG. 8. A threaded portion 64 is configured to engage with the internal threads of the collar 52 during assembly. A pair of retaining rings 66, 68 engage either side of fixation plate 42, the lower retaining ring 66 resting upon collar 52 and the upper retaining ring 68 compressed between the fixation plate 42 and an upper set screw 70. The upper set screw 70 has a threaded portion 72 intended to engage with the threaded interior side of wall portions 48 of the receiver 46 upon assembly. The upper set screw 70 may have a head configuration designed to be engaged by a wrench or other tightening tool.
  • Referring to FIG. 9, while an upper portion of the interior of collar 52 is threaded to engage with lower set screw 60, the lower portion is not threaded but has a tapered interior portion having a more narrow diameter at the bottom of the collar 52. During assembly of the fixation system, the collar 52 is dropped into the receiver 46, the shoulder 54 resting upon the base 50. Note that each of the components forming the coupling mechanism has an interior channel or aperture configured to allow the components to be placed upon and encircle the post 18. The collet 56 is placed into collar 52, the outer diameter of the collet 56 being greater along a portion of the longitudinal axis of collet 56 than the interior diameter of collar 52, as shown in FIG. 8. The lower set screw 60 may then be threaded into collar 52, thus engaging collet 56 and pushing collet 56 downward through the collar 52 until the compressible arms 58 are forced to grip and be secured to post 18. Engagement of the post 18 by the collet 56 locks the collet 56 and the other components of the coupling mechanism into place relative to the bone screw 10 for fixation to the fixation plate 42.
  • Note that the collet 56 may be locked onto post 18 at any position along the longitudinal axis of post 18, affording flexibility in the placement of the coupling mechanism components. In other bone screw embodiments, the collet may engage with the threaded portion of the bone screw. The flexibility in placement of the collet is important due to the variability in placement of the bone screw 10 depending on the anatomy of the patient. Once the receiver 46, collar 52, and collet 56 are locked into place onto bone screw 10, the fixation plate 42 may be linked to the bone screw 10 by placing retainer rings 66, 68 over the post 18 on either side of the fixation plate 42 and locking the fixation plate 42 into place by threading upper set screw 70 into receiver 46 to complete the assembly.
  • Further referring to FIG. 9, the recess 20 extends into the bone screw 10 to create a keyed portion of passage 22 that extends the length of the bone screw 10. The keyed portion may serve as an engagement point for a driver as discussed above.
  • Referring to FIG. 10, the embodiment of the bone fixation system shown in FIGS. 7-9 is shown installed into a patient's spine. In practice, the bone screws 10 may be individually installed prior to the installation of the fixation plate 42 across the multiple bone screws 10.
  • Further referring to FIGS. 7-10, the fixation device or plate 42 as shown is configured to be attached from the top of and after installation of bone screws 10. In an alternative embodiment (not shown), a fixation plate with multiple though-holes may be configured to be applied directly to one or more bones or bone fragments to be fused together prior to the installation of bone screw 10. The through holes are configured to allow bone screw 10 to secure the fixation plate 42 to the bone. Alternatively, a single aperture in the fixation plate may be provided and configured to accept multiple bone screws 10. After locating the fixation plate across the fracture site or joint, bone screws 10 may be driven though the through-holes and into the bone on both sides of the fracture site or joint, thereby securing the fixation plate 42 to the pieces of bone to be joined.
  • The various bone fixation or instrumentation systems described herein as exemplary embodiments of the invention may be utilized in the performance of bone fixation procedures using a streamlined method that is intended to simplify and shorten conventional bone fixation procedures. Prior to operating, imaging of the patient may be utilized to determine the number and locations of bone screws that will be required as part of the procedure. Further, an image guidance system may be utilized as part of the procedure to aid in the placement of the various components. In the case of an open procedure, an entry site is created in the patient along the portion of the bone into which the bone screws will be inserted. In the case of a minimally invasive procedure, individual entry ports may be utilized for implantation of individual bone screws. Certain embodiments of the invention described herein are particularly suited to a minimally invasive approach because the coupling components are placed upon the screw from the top, allowing insertion and connection of the components via the small percutaneous aperture created for the screw itself in contrast to other designs requiring the use of coupling components that are not in line with the longitudinal axis of the screw, which may require an open procedure.
  • After creating the entry site and determining the point of insertion of a bone screw, the drill may be inserted into the bone screw, using the holding device to hold the drill in place, if desired, and utilized to drill into the bone simultaneously with the bone screw.
  • In addition to the embodiment of the invention shown in use on a portion of the spine in FIGS. 4-6, the invention is also applicable to other surgical procedures involving a bone anchoring element or bone screw. FIGS. 11-24, discussed below, show various other embodiments of the invention as applied to various portions of the skeletal system.
  • Referring to FIGS. 11-12, in an exemplary embodiment of the invention, the bone screw 10 and associated drill 28 are used in a posterior trans-articular fixation procedure of the first (C1) and second (C2) cervical vertebrae 74, 76. An entry site is created posterior the C2 vertebra 76 and an insertion point on the surface of the C2 vertebra 76 is determined. The drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point through the C2 vertebra 76 and into the C1 vertebra 74, thereby fixating the two bones. The drill 28 is then removed from the bone screw 10 located in the fixated region. A second bone screw 10 (not shown) is then inserted in a similar fashion to ensure proper fixation of the bones. The two bone screws 10 are normally offset to opposite sides of the midline of the vertebrae 74, 76.
  • Referring to FIGS. 13 and 14, in another exemplary embodiment of the invention, the bone screw 10 and associated drill 28 are used in a trans-articular suffusion procedure of the lower lumbar region involving the fourth (L4) and fifth (L5) lumbar vertebrae 78, 80. An entry site is created posterior the L4 vertebra 78 and an insertion point on the surface of the L4 vertebra 78 is determined. The drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point through the L4 vertebra 78 and into the L5 vertebra 80, thereby fixating the two bones. The drill 28 is then removed from the bone screw 10 located in the fixated region.
  • Referring to FIGS. 15-17, in another exemplary embodiment of the invention, the bone screw 10 and associated drill 28 are used in a lumbosacral fixation procedure involving the fifth lumbar (L5) and first sacral (S1) vertebrae 82, 84. An entry site is created posterior the L5 vertebra 82 and a first insertion point on the surface of the L5 vertebra 82 is determined. The drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point through the L5 vertebra 82 and into the S1 vertebra 84, thereby fixating the two bones. The drill 28 is then removed from the bone screw 10 located in the fixated region. A second bone screw 10 is then inserted in a similar fashion to ensure proper fixation of the bones. The two screws 10 are normally offset to opposite sides of the midline of the vertebrae 82, 84.
  • Referring to FIGS. 18-20, in another exemplary embodiment of the invention, the bone screw 10 and associated drill 28 are used in a fixation procedure of a fracture of the odontoid process 86 of the C2 vertebra 88. An entry site is created anterior the C2 vertebra 88 and a first insertion point on the surface of the C2 vertebra 88 is determined. The drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point through the C2 vertebra 88 and into the odontoid process 86, thereby fixating the fracture. The drill 28 is then removed from the bone screw 10 located in the fixated region. A second bone screw 10 may be inserted in a similar fashion through a second insertion point, as shown in FIG. 20, to ensure proper fixation of the fracture. The two screws 10 are normally offset to opposite sides of the midline of the C2 vertebrae 88.
  • Referring to FIGS. 21 and 22, in another exemplary embodiment of the invention, the bone screw 10 and associated drill 28 are used in an internal fixation procedure of a fractured clavicle 94. For a clavicle fracture such as the one shown, an entry site is chosen to allow insertion of a bone screw 10, across the fracture site in the longitudinal direction of the clavicle bone. The drill 28 is then inserted into the bone screw 10 and the screw is driven from the insertion point on the first fractured portion 90, through the fracture site along the longitudinal direction of the clavicle bone 94, and into a second fractured portion 92. The drill 28 is then removed from the bone screw 10 located in the fixated region.
  • Referring to FIGS. 23 and 24, in another exemplary embodiment of the invention, the bone screw 10 and associated drill 28 are used in a fixation procedure of the fifth metatarsal 100. For a metatarsal fracture such as the one shown, an entry site is chosen to allow insertion of a bone screw 10 across the fracture site in the longitudinal direction of the metatarsal bone 100. The drill 28 is then inserted into the bone screw 28 and the screw is driven from the insertion point into a first fractured portion 96, through the fracture site along the longitudinal direction of the metatarsal bone 100, and into a second fractured portion 98. The drill 28 is then removed from the bone screw 10 located in the fixated region.
  • If a fixation plate is to be installed, a portion of each of the bone screws is left exposed outside of the bone material as shown in FIG. 9. After installation of the desired number of bone screws, the coupling mechanism is utilized to connect the bone screws to a linking device, such as a fixation rod or plate as shown and described herein. In the case of a minimally invasive procedure, multiple drills may be utilized to aid in the installation of the coupling components and the linking device may be threaded beneath the patient's skin between the various bone screws that are being linked to each other. Alternatively, as discussed above, the fixation plate 42 may be placed directly onto the bone or bones prior to installation of the bone screws 10. After positioning the fixation plate 42 onto the bone, bone screws 10 are driven through the fixation plate 42 and into the bone, thereby securing the fixation plate 42 directly to the bone.
  • In the embodiments described herein, drill 28 is provided with drill tip 34 to make the combination of bone screw 10 and drill 28 self-drilling. It should be noted that after insertion of bone screw 10, drill 28 may be removed, thereby ensuring that no sharp or pointed objects (e.g., drill tip 34) remain within the patent.
  • While the detailed drawings and specific examples given herein describe various exemplary embodiments, they serve the purpose of illustration only. It is to be understood that the invention is not limited in its application to the details of construction and arrangements of components set forth in the preceding description or illustrated in the drawings. It should be noted that the components and/or assemblies of the bone fixation system may be constructed from various materials known in the art. Further, while several examples show the invention in the context of various skeletal regions, the invention is applicable to surgical procedures involving other regions not described in the embodiments contained herein. Further, the order of performance of the method steps described with respect to bone fixation procedures utilizing the various embodiments of the present invention may vary. Furthermore, other substitutions, modifications, changes and omissions may be made in the design, operating conditions, and arrangements of the exemplary embodiments without departing from the scope of the invention as expressed in the appended claims.

Claims (33)

1. A bone fixation system, comprising:
a bone screw having a longitudinal axis;
a passage in the bone screw extending along the longitudinal axis, the passage having a proximal opening at a proximal end of the bone screw and a distal opening at a distal end of the bone screw; and
a drill extending through the passage, a first end of the drill extending out the distal opening, whereby the combination of the bone screw and the drill is self-drilling.
2. The bone fixation system of claim 1, wherein a second end of the drill extends out the proximal opening.
3. The bone fixation system of claim 1, further comprising a tubular holding device adapted to be placed over the drill and removably coupled to the bone screw.
4. The bone fixation system of claim 3, wherein the holding device has a plurality of prongs and the bone screw has a flange and wherein the prongs snap onto the flange to couple the holding device to the bone screw.
5. The bone fixation system of claim 1, wherein the passage comprises a keyed portion and the drill comprises a keyed segment, the keyed segment and the keyed portion configured to interlock with one another wherein rotation of the drill results in a corresponding rotation of the bone screw.
6. The bone fixation system of claim 1, further comprising:
a second drill;
a second bone screw having a second longitudinal passage configured to receive the second drill;
a linking device configured to connect the bone screw to the second bone screw; and
a coupling mechanism adapted to couple the linking device to the bone screw, wherein the coupling mechanism comprises at least one annular component sized to be fitted over the bone screw and the drill.
7. The bone fixation system of claim 6, wherein the at least one component is a collet configured to be secured to the bone screw.
8. The bone fixation system of claim 6, wherein the linking device is a fixation plate.
9. The bone fixation system of claim 1, wherein the bone screw further comprises a plurality of holes extending radially outward from the passage along the longitudinal axis of the bone screw.
10. A bone fixation instrumentation kit, comprising:
a bone screw having a passage extending along a longitudinal axis of the bone screw, the passage having a proximal opening at a proximal end of the screw and a distal opening at a distal end of the screw; and
a driver adapted to extend through the passage, whereby the combination of the bone screw and the driver is self-drilling.
11. The bone fixation instrumentation kit of claim 10, wherein the driver is a drill and the drill is longer than the passage whereby an end of the drill is adapted to extend out the proximal opening.
12. The bone fixation instrumentation kit of claim 11, further comprising a tubular holding device adapted to be placed over the drill and removably coupled to the bone screw.
13. The bone fixation instrumentation kit of claim 11, wherein the passage comprises a keyed portion and the drill comprises a keyed segment, the keyed segment and the keyed portion configured to interlock with one another wherein rotation of the drill results in a corresponding rotation of the bone screw.
14. The bone instrumentation kit of claim 10, further comprising:
a second driver;
a second bone screw having a second longitudinal passage configured to receive the second driver;
a linking device configured to connect the bone screw to the second bone screw; and
a coupling mechanism adapted to couple the linking device to the bone screw, wherein the coupling mechanism comprises at least one annular component sized to be fitted over the bone screw and the driver.
15. The bone fixation instrumentation kit of claim 14, wherein the at least one annular component is a collet configured to be secured to the bone screw.
16. The bone fixation instrumentation kit of claim 10, wherein the bone screw further comprises a plurality of holes extending radially outward from the passage along the longitudinal axis of the bone screw.
17. The bone fixation instrumentation kit of claim 14, wherein the linking device is a fixation plate.
18. A method for connecting a bone screw to a bone, comprising:
opening an aperture in a patient to permit access to a bone;
providing a bone screw having a passage extending along a longitudinal axis of the bone screw, the passage having a keyed portion, a proximal opening at a proximal end of the bone screw, and a distal opening at a distal end of the bone screw;
providing a drill having a shaft, a cutting tip, and a keyed segment configured to interlock with the keyed portion;
inserting the drill into the passage wherein the cutting tip protrudes from the distal opening and the keyed segment interlocks with the keyed portion;
rotating the drill and therefore the bone screw to drill a pilot hole and screw the bone screw into the bone; and
removing the drill from the bone screw without also removing the bone screw from the bone.
19. The method of claim 18, wherein the shaft protrudes from the proximal opening and extends through the aperture in the patient.
20. The method of claim 18, further comprising:
providing a tubular holding device configured to be placed over the drill to lock the drill to the bone screw; and
coupling the holding device to the bone screw.
21. The method of claim 20, further comprising removing the holding device from the bone screw.
22. A method for attaching a bone screw to a plurality of bone segments comprising:
opening an aperture in a patient to permit access to a first bone segment and a second bone segment;
providing a bone screw having a passage extending along a longitudinal axis of the bone screw, the passage having a proximal opening at a proximal end of the bone screw and a distal opening at a distal end of the bone screw;
providing a driver;
inserting the driver into the passage;
driving the screw into and through the first bone segment and into the second bone segment;
removing the driver from the passage without removing the bone screw from the first and second bone segments.
23. The method of claim 22, wherein the first bone segment is a first vertebral bone and the second bone segment is a second vertebral bone, wherein the first vertebral bone is adjacent the second vertebral bone.
24. The method of claim 23, wherein the first vertebral bone is a first cervical vertebra and the second vertebral bone is a second cervical vertebra.
25. The method of claim 24, further comprising:
providing a second bone screw having a passage extending along a longitudinal axis of the second bone screw;
inserting the driver into the passage of the second bone screw;
driving the second bone screw into and through the first bone segment and into the second bone segment;
removing the driver from the passage of the second bone screw without removing the second bone screw from the first and second bone segments.
26. The method of claim 23, wherein the first bone segment is fourth lumbar vertebra and the second bone segment is fifth lumbar vertebra.
27. The method of claim 23, wherein the first bone segment is a fifth lumbar vertebra and the second bone segment is first sacral vertebra.
28. The method of claim 27, further comprising:
providing a second bone screw having a passage extending along a longitudinal axis of the second bone screw;
inserting the driver into the passage of the second bone screw;
driving the second bone screw into and through the first bone segment and into the second bone segment;
removing the driver from the passage of the second bone screw without removing the second bone screw from the first and second bone segments.
29. The method of claim 22, wherein the first bone segment comprises a first portion of a fractured bone and the second bone segment comprises a second portion of the fractured bone.
30. The method of claim 29, wherein the fractured bone is a second cervical vertebra and the second portion is the odontoid process of the second cervical vertebra.
31. The method of claim 30, further comprising:
providing a second bone screw having a passage extending along a longitudinal axis of the second bone screw;
inserting the driver into the passage of the second bone screw;
driving the second bone screw into and through the first bone segment and into the second bone segment;
removing the driver from the passage of the second bone screw without removing the second bone screw from the first and second bone segments.
32. The method of claim 29, wherein the fractured bone comprises a clavicle bone.
33. The method of claim 29, wherein the fractured bone comprises a fifth metatarsal bone.
US11/349,763 2004-06-09 2006-02-08 Bone fixation system Abandoned US20060149245A1 (en)

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US10/864,673 US7938848B2 (en) 2004-06-09 2004-06-09 Spinal fixation system
US11/071,604 US7744635B2 (en) 2004-06-09 2005-03-03 Spinal fixation system
US11/349,763 US20060149245A1 (en) 2004-06-09 2006-02-08 Bone fixation system

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US12/825,176 Active 2025-02-11 US8617209B2 (en) 2004-06-09 2010-06-28 Spinal fixation system
US14/137,040 Active 2024-06-15 US9168151B2 (en) 2004-06-09 2013-12-20 Spinal fixation system

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US8617209B2 (en) 2013-12-31
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US20050277931A1 (en) 2005-12-15
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US7744635B2 (en) 2010-06-29
AU2005253980A1 (en) 2005-12-29

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