US20050159747A1 - Volar fixation system including guide - Google Patents
Volar fixation system including guide Download PDFInfo
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- US20050159747A1 US20050159747A1 US11/077,833 US7783305A US2005159747A1 US 20050159747 A1 US20050159747 A1 US 20050159747A1 US 7783305 A US7783305 A US 7783305A US 2005159747 A1 US2005159747 A1 US 2005159747A1
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- volar
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- head portion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1728—Guides or aligning means for drills, mills, pins or wires for holes for bone plates or plate screws
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
- A61B17/1782—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hand or wrist
-
- 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
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
-
- 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
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7291—Intramedullary pins, nails or other devices for small bones, e.g. in the foot, ankle, hand or wrist
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8033—Cortical 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
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8033—Cortical 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
- A61B17/8042—Cortical 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 the additional component being a cover over the screw head
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8052—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
- A61B17/8057—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded the interlocking form comprising a thread
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8625—Shanks, i.e. parts contacting bone tissue
- A61B17/863—Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1725—Guides or aligning means for drills, mills, pins or wires for applying transverse screws or pins through intramedullary nails or pins
Definitions
- This invention relates broadly to surgical devices. More particularly, this invention relates to a bone fixation system, and particularly to a fixation system adapted to fixate a distal radial fracture.
- a Colles' fracture is a fracture resulting from compressive forces being placed on the distal radius 10 , and which causes backward displacement of the distal fragment 12 and radial deviation of the hand at the wrist 14 .
- a Colles' fracture will result in multiple bone fragments 16 , 18 , 20 which are movable and out of alignment relative to each other. If not properly treated, such fractures result in permanent wrist deformity. It is therefore important to align the fracture and fixate the bones relative to each other so that proper healing may occur.
- Alignment and fixation are typically performed by one of several methods: casting, external fixation, interosseous wiring, and plating.
- Casting is non-invasive, but may not be able to maintain alignment of the fracture where many bone fragments exist. Therefore, as an alternative, external fixators may be used.
- External fixators utilize a method known as ligamentotaxis, which provides distraction forces across the joint and permits the fracture to be aligned based upon the tension placed on the surrounding ligaments.
- ligamentotaxis which provides distraction forces across the joint and permits the fracture to be aligned based upon the tension placed on the surrounding ligaments.
- external fixators can maintain the position of the wrist bones, it may nevertheless be difficult in certain fractures to first provide the bones in proper alignment.
- external fixators are often not suitable for fractures resulting in multiple bone fragments.
- Interosseous wiring is an invasive procedure whereby screws are positioned into the various fragments and the screws are then wired together as bracing. This is a difficult and time consuming procedure. Moreover, unless the bracing is quite complex, the fracture may not be properly stabilized.
- Plating utilizes a stabilizing metal plate typically against the dorsal side of the bones, and a set of parallel pins extending from the plate into the holes drilled in the bone fragments to provide stabilized fixation of the fragments.
- the currently available plate systems fail to provide desirable alignment and stabilization.
- a volar fixation system which generally includes a T-shaped plate intended to be positioned against the volar side of the radial bone, a plurality of bone screws for securing the plate along a non-fractured portion of the radial bone, and a plurality of bone pegs which extend from the plate and into bone fragments of a Colles' fracture.
- the plate is generally a T-shaped plate defining an elongate body, a head portion angled relative to the body, a first side which is intended to contact the bone, and a second side opposite the first side.
- the body portion includes a plurality of countersunk screw holes for the extension of the bone screws therethrough.
- the head portion includes a plurality of threaded peg holes for receiving the pegs therethrough.
- the peg holes are preferably non-linearly arranged.
- the peg holes are preferably linearly arranged.
- the peg holes are positioned increasingly distal in a medial to lateral direction along the second side.
- axes through the holes are oblique relative to each other, and are preferably angled relative to each other in two dimensions.
- the pegs having a threaded head and a relatively smooth cylindrical shaft.
- the system preferably also includes a guide plate which temporarily sits on top of the volar plate and includes holes oriented according to the axes of the peg holes for guiding a drill into the bone fragments at the required orientation.
- the volar plate and guide plate are also preferably provided with mating elements to temporarily stabilize the guide plate on the volar plate during the hole drilling process.
- the volar plate In use, the volar plate is positioned with its first side against the volar side of the radius and bone screws are inserted through the bone screw holes into the radius to secure the volar plate to the radius. The bone fragments are then aligned and the guide plate is positioned on the second side of the volar plate. A drill, guided by guide holes in the guide plate, drills holes into the bone fragments, and the guide plate is then removed.
- the pegs are then inserted through the peg holes and into the holes in the bone, and the heads of the pegs are threadably engaged in the volar plate.
- the volar fixation system thereby secures the bone fragments in their proper orientation.
- FIG. 1 is an illustration of an extremity subject to a Colles' fracture
- FIG. 2 is a top volar view of a right hand volar fixation system according to a first embodiment of the invention
- FIG. 3 is a side view of a bone peg according to the first embodiment of the volar fixation system of the invention
- FIG. 4 is a side view of a bone screw of the volar fixation system of the invention.
- FIG. 5 is a side view of the right hand volar plate of the volar fixation system according to the first embodiment of the invention.
- FIG. 6 is a front end view of the right hand volar plate of the volar fixation system according to the first embodiment of the invention.
- FIG. 7 is an exploded side view of the right hand volar plate and guide plate according to the first embodiment of the fixation system of the invention.
- FIG. 8 is a side view of the guide plate positioned on the right hand volar plate to provide drill guide paths in accord with the invention.
- FIG. 9 is an illustration of the first embodiment of the volar fixation system provided in situ aligning and stabilizing a Colles' fracture
- FIG. 10 is a top volar view of a left hand volar fixation system according to the second embodiment of the invention.
- FIG. 11 is a lateral side view of the left hand volar fixation system according to the second embodiment of the invention.
- FIG. 12 is a bottom view of the left hand volar fixation system according to the second embodiment of the invention.
- FIG. 13 is an enlarged side elevation of a bone peg according to the second embodiment of the volar fixation system of the invention.
- FIG. 14 is a proximal end view of the bone peg of FIG. 13 ;
- FIG. 15 is first partial top view of the head portion of the left hand volar plate according to the second embodiment of the volar fixation system of the invention.
- FIGS. 16-19 are section views across line 16 - 16 , 17 - 17 , 18 - 18 , and 19 - 19 , respectively in FIG. 15 ;
- FIG. 20 is second partial top view of the head portion of the left hand volar plate according to the second embodiment of the volar fixation system of the invention.
- FIGS. 21-24 are section views across line 21 - 21 , 22 - 22 , 23 - 23 , and 24 - 24 , respectively in FIG. 20 .
- a first embodiment of a volar fixation system 100 for aligning and stabilizing multiple bone fragments in a Colles' fracture generally includes a substantially rigid T-shaped plate 102 intended to be positioned against the volar side of the radial bone, a plurality of preferably self-tapping bone screws 104 for securing the plate 102 along a non-fractured portion of the radial bone, and a plurality of bone pegs 108 which extend from the plate 102 and into bone fragments of a Colles' fracture.
- the T-shaped plate 102 defines a head portion 116 , an elongate body portion 118 angled relative to the head portion, a first side 120 which is intended to contact the bone, and a second side 122 opposite the first side.
- the first side 120 at the head portion is preferably planar, as is the first side at the body portion.
- the first side preferably defines two planar portions.
- the angle ⁇ between the head portion 116 and the body portion 118 is preferably approximately 18° and bent at a radius of approximately 1.00 inch ( FIG. 5 ).
- the distal edge 121 of the head portion 116 is preferably angled proximally toward the medial side at an angle a, e.g., 5°, relative to a line P, which is perpendicular to the body portion.
- the head portion 116 preferably has a width of 0.913 inch and a greatest proximal-distal dimension (i.e., from the corner of angle a to the body portion) of approximately 0.69 inch, and the body portion preferably has a width of 0.375 inch and a length of 1.40 inches.
- the plate 102 preferably has a thickness of approximately 0.098 inch.
- the plate 102 is preferably made from a titanium alloy, such as Ti-6A-4V.
- the body portion 118 includes three preferably countersunk screw holes 124 , 126 , 128 for the extension of the bone screws 104 therethrough.
- the first screw hole 124 has a center preferably 0.235 inch from the end of the body portion
- the second screw hole 126 has a center preferably 0.630 inch from the end of the body portion
- the third screw hole 128 is preferably generally elliptical (or oval) and defines foci-like locations at 1.020 inches and 1.050 inches from the end of the body portion.
- the head portion 116 includes four threaded peg holes 130 , 132 , 134 , 136 for individually receiving the pegs 108 therethrough.
- the peg holes 130 , 132 , 134 , 136 are preferably non-linearly arranged along the head portion 116 , and are provided such that the adjacent peg holes are provided further distally in a medial to lateral direction along the second side.
- the peg holes are preferably arranged along a parabolic curve, with the center of peg hole 130 located approximately 0.321 inch proximal line P and approximately 0.719 inch medial of the lateral edge 137 of the head portion, the center of peg hole 132 located approximately 0.296 inch proximal line P and approximately 0.544 inch medial of the lateral edge 137 , the center of peg hole 134 located approximately 0.250 inch proximal line P and approximately 0.369 inch medial of the lateral edge 137 , and the center of peg hole 136 located approximately 0.191 inch proximal line P and approximately 0.194 inch medial of the lateral edge 137 .
- the peg holes define axes A 1 , A 2 , A 3 , A 4 which are oblique (not parallel) relative to each other, and more preferably are angled in two dimensions (medial/lateral and proximal/distal) relative to each other; i.e., the pegs once inserted into the peg holes are also angled in two dimensions relative to each other.
- the first axis A 1 of the first peg hole 130 is preferably directed normal to the first side 120 of the head portion 116 .
- the axis A 2 of the adjacent peg hole 132 is preferably angled approximately 1-7° distal and lateral relative to the first axis A 1 , and more preferably approximately 2.5° distal and lateral relative to the first axis A 1 .
- the axis A 3 of the peg hole 134 laterally adjacent the second peg hole 132 is preferably angled approximately 7-13° distal and lateral relative to the first axis A 1 , and more preferably approximately 10° distal and lateral relative to the first axis A 1 .
- the axis A 4 of the peg hole 134 laterally adjacent the third peg hole 132 is preferably angled approximately 10-30° distal and lateral relative to the first axis A 1 , and more preferably approximately 20° distal and lateral relative to the first axis A 1 .
- the second side of the head portion 116 , distal of the peg holes 130 , 132 , 134 , 136 is preferably beveled.
- the pegs 108 preferably approximately 0.872 inch in length, each have a threaded head 138 adapted to threadably engage the threads about the peg holes 130 , 132 , 134 , 136 , and have a relatively smooth non-threaded cylindrical shaft 140 .
- the shafts 140 are preferably approximately 0.0675 inch in diameter and 0.765 inch in length. Such dimensions permit the pegs to adequately support the bone fragments such that the bone is able to heal correctly.
- the pegs 108 are also preferably made from titanium alloy, and may be coated in a ceramic, e.g., titanium nitride, to provide a bone interface which will not adversely affect bone healing.
- the system 100 preferably also includes a guide plate 146 which temporarily sits on the second side 122 of the volar plate 102 and includes guide holes 148 , 150 , 152 , 154 (illustrated in overlapping section in FIG. 8 ) oriented according to the axes A 1 , A 2 , A 3 , A 4 of the peg holes for guiding a drill into the bone fragments at the required orientation. That is, the guide holes together with the peg holes define a drill guide path along the axes with sufficient depth to accurately guide a drill (not shown) to drill holes at the desired pin orientations.
- the volar plate 102 and guide plate 146 are also preferably provided with mating elements, such as a plurality of holes 156 , 158 on the second side of the volar plate ( FIG. 2 ), and a plurality of protuberances 160 on the mating side of the guide plate ( FIG. 7 ), to temporarily stabilize the guide plate on the volar plate during the hole drilling process.
- mating elements such as a plurality of holes 156 , 158 on the second side of the volar plate ( FIG. 2 ), and a plurality of protuberances 160 on the mating side of the guide plate ( FIG. 7 ), to temporarily stabilize the guide plate on the volar plate during the hole drilling process.
- the volar plate 102 is positioned with its first side 120 against the volar side of the radius.
- Bone screws 104 are inserted through the bone screw holes 124 , 126 , 128 into the radius bone 10 to secure the volar plate 102 to the radius.
- the bone fragments 16 , 18 , 20 are then aligned with the radius 10 .
- the guide plate 146 is positioned on the second side of the volar plate.
- a drill guided by a guide path formed by the peg holes and the guide holes, drills holes into and between the bone fragments 16 , 18 , 20 (and possibly also a portion of the integral radius, depending upon the particular location and extent of the fracture), and the guide plate is then removed.
- the pegs 108 are then inserted through the peg holes 130 , 132 , 134 , 136 and into the holes drilled into the fragments, and the heads of the pegs are threadably engaged in the volar plate.
- the pegs 108 extending through the oblique-axis peg holes 130 , 132 , 134 , 136 , are positioned immediately below the subchondral bone of the radius and support the bone fragments for proper healing.
- the volar fixation system thereby secures the bone fragments in their proper orientation.
- a second embodiment of a volar plate 210 substantially similar to the first embodiment (with like parts having numbers incremented by 100 ) and used in substantially the same manner as the first embodiment is shown.
- the plate 210 preferably has a length of approximately 2.35 inches, which is approximately 0.35 inch greater than in the first embodiment. This additional length accommodates an extra bone screw hole 229 in the body of the volar plate such that the volar plate preferably includes four bone screw holes 224 , 226 , 228 , 229 .
- the additional bone screw in screw hole 229 increases plate stability over the three holes of the first embodiment.
- the plate 210 preferably tapers in thickness from the body portion 218 to the head portion 216 .
- a preferred taper provides a proximal body portion 218 thickness of approximately 0.098 inch and head portion 216 thickness of approximately 0.078 inch.
- the taper decreases the thickness of the head portion 216 relative to the body such that the weight of the volar plate is reduced and an improved tendon clearance is provided.
- the distal edge of the head portion 216 has an increased taper (preferably approximately 60° relative to a line normal to the head) to a distal edge 221 .
- the edge 221 is broken (i.e., made blunt) to prevent irritation or disturbance to the surrounding anatomy.
- the head portion 216 includes four threaded peg holes 230 , 232 , 234 , 236 for individually receiving pegs 208 therethrough ( FIGS. 13 and 14 ), and a guide hole 256 for alignment of a guide plate.
- the peg holes 230 , 232 , 234 , 236 preferably 0.100 inch in diameter, are preferably linearly arranged along the head portion 216 , and are provided such that the adjacent peg holes are provided further distally in a medial to lateral direction along the first and second sides. Referring to FIG.
- the center of peg hole 230 is located approximately 0.321 inch proximal line P and approximately 0.750 inch medial of the lateral edge 237 of the head portion
- the center of peg hole 232 is located approximately 0.306 inch proximal line P and 0.557 inch medial of the lateral edge 237
- the center of peg hole 234 is located approximately 0.289 inch proximal line P and approximately 0.364 inch medial of the lateral edge 237
- the center of peg hole 236 is located approximately 0.272 inch proximal line P and approximately 0.171 inch medial of the lateral edge 237 .
- the distance from each of the peg holes to the distal edge 221 of the volar plate is relatively greater than in the first embodiment, and provides a preferred alignment with respect to the tapered distal edge 221 .
- the peg holes define axes A 1 , A 2 , A 3 , A 4 which are oblique relative to each other, and more preferably are angled in two dimensions (medial/lateral and proximal/distal) relative to each other; i.e., the pegs 208 once inserted into the peg holes are also angled in two dimensions relative to each other.
- the first axis A 1 of the first peg hole 230 is preferably directed normal ( FIGS. 16 and 21 ) to the first side 220 of the head portion 216 .
- the axis A 2 of peg hole 232 is preferably angled approximately 1-7° distal ( FIG.
- the axis A 3 of peg hole 234 is preferably angled approximately 7-13° distal ( FIG. 18 ) and approximately 7-13° lateral ( FIG. 23 ) relative to axis A 1 , and more preferably approximately 10° both distal and lateral relative to axis A 1 .
- Axis A 4 of the peg hole 234 is preferably angled approximately 10-30° distal ( FIG. 19 ) and approximately 10-30° lateral ( FIG. 24 ) relative to axis A 1 , and more preferably approximately 20° both distal and lateral relative to axis A 1 .
- each of the peg holes has a countersunk portion 270 , 272 , 274 , 276 , respectively, for receiving the head 238 of peg 208 .
- Countersunk portions 270 , 272 are each preferably approximately 0.030 inch deep and threaded according to the head of the pegs, as described below.
- Countersunk portion 274 is preferably approximately 0.042 inch deep and likewise threaded.
- Countersunk portion 276 is preferably approximately 0.056 inch deep and also threaded. The respective depths of the countersunk portions are adapted to better accommodate the heads 238 of the pegs 208 relative to the respective axes of the peg holes.
- the pegs 208 each have a threaded head 238 adapted to threadably engage threads about the peg holes 230 , 232 , 234 , 236 , and have a relatively smooth non-threaded cylindrical shaft 240 .
- the heads 238 preferably include a no. 5 thread 280 at a count of 44 per inch.
- the heads 238 are rounded and include a hex socket 282 to facilitate stabilized threading into the peg holes. This design accommodates the reduced thickness of the volar plate at the head portion 216 .
- the shafts 240 are preferably approximately 0.0792 inch (2 mm) in diameter and 0.765 inch in length.
- the pegs 208 are also preferably made from titanium alloy, and may be ‘tiodized’ to provide a strong finish which does not adversely affect bone healing.
- volar fixation system and a method of aligning and stabilizing a Colles' fracture. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular materials for the elements of the system have been disclosed, it will be appreciated that other materials may be used as well. In addition, while a particular numbers of screw holes in the volar plates and bone screws have been described, it will be understood another number of screw holes and screws may be provided. Further, fewer screws than the number of screw holes may be used to secure to the volar plate to the radius.
- peg holes and bone pegs may be used, preferably such that at least two pegs angled in two dimensions relative to each other are provided.
- the peg holes lie along a parabolic curve, it will be appreciated that they can lie along another curve.
- other angles can also be used.
- the peg holes may be provided at other distances relative thereto.
- medial/lateral and proximal/distal angles for the peg hole axes has been disclosed, it will be appreciated that yet other angles may be used in accord with the invention.
- each embodiment may be formed in either a right- or left-handed model, with such alternate models being mirror images of the models described.
- aspects from each of the embodiments may be combined. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.
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Abstract
Description
- This application is a continuation of U.S. Ser. No. 10/762,695, filed Jan. 22, 2004, which is a continuation-in-part of U.S. Ser. No. 10/315,787, filed Dec. 10, 2002, which is a continuation-in-part of U.S. Ser. No. 10/159,611, filed May 30, 2002, which is a continuation-in-part of U.S. Ser. No. 09/735,228, filed Dec. 12, 2000 and now issued as U.S. Pat. No. 6,440,135, which is a continuation-in-part of U.S. Ser. No. 09/524,058, filed Mar. 13, 2000 and now issued as U.S. Pat. No. 6,364,882, and U.S. Ser. No. 09/495,854, filed Feb. 1, 2000 and now issued as U.S. Pat. No. 6,358,250, the complete disclosure of which are hereby incorporated by reference herein.
- 1. Field of the Invention
- This invention relates broadly to surgical devices. More particularly, this invention relates to a bone fixation system, and particularly to a fixation system adapted to fixate a distal radial fracture.
- 2. State of the Art
- Referring to
FIG. 1 , a Colles' fracture is a fracture resulting from compressive forces being placed on thedistal radius 10, and which causes backward displacement of thedistal fragment 12 and radial deviation of the hand at thewrist 14. Often, a Colles' fracture will result inmultiple bone fragments - Alignment and fixation are typically performed by one of several methods: casting, external fixation, interosseous wiring, and plating. Casting is non-invasive, but may not be able to maintain alignment of the fracture where many bone fragments exist. Therefore, as an alternative, external fixators may be used. External fixators utilize a method known as ligamentotaxis, which provides distraction forces across the joint and permits the fracture to be aligned based upon the tension placed on the surrounding ligaments. However, while external fixators can maintain the position of the wrist bones, it may nevertheless be difficult in certain fractures to first provide the bones in proper alignment. In addition, external fixators are often not suitable for fractures resulting in multiple bone fragments. Interosseous wiring is an invasive procedure whereby screws are positioned into the various fragments and the screws are then wired together as bracing. This is a difficult and time consuming procedure. Moreover, unless the bracing is quite complex, the fracture may not be properly stabilized. Plating utilizes a stabilizing metal plate typically against the dorsal side of the bones, and a set of parallel pins extending from the plate into the holes drilled in the bone fragments to provide stabilized fixation of the fragments. However, the currently available plate systems fail to provide desirable alignment and stabilization.
- It is therefore an object of the invention to provide an improved fixation and alignment system for a Colles' fracture.
- It is another object of the invention to provide a volar fixation system which desirably aligns and stabilizes multiple bone fragments in a distal radial fracture to permit proper healing.
- In accord with these objects, which will be discussed in detail below, a volar fixation system is provided which generally includes a T-shaped plate intended to be positioned against the volar side of the radial bone, a plurality of bone screws for securing the plate along a non-fractured portion of the radial bone, and a plurality of bone pegs which extend from the plate and into bone fragments of a Colles' fracture.
- The plate is generally a T-shaped plate defining an elongate body, a head portion angled relative to the body, a first side which is intended to contact the bone, and a second side opposite the first side. The body portion includes a plurality of countersunk screw holes for the extension of the bone screws therethrough. The head portion includes a plurality of threaded peg holes for receiving the pegs therethrough. According to a first embodiment, the peg holes are preferably non-linearly arranged. According to a second embodiment, the peg holes are preferably linearly arranged. In either embodiment, the peg holes are positioned increasingly distal in a medial to lateral direction along the second side. According to a preferred aspect of the invention, axes through the holes are oblique relative to each other, and are preferably angled relative to each other in two dimensions. The pegs having a threaded head and a relatively smooth cylindrical shaft.
- The system preferably also includes a guide plate which temporarily sits on top of the volar plate and includes holes oriented according to the axes of the peg holes for guiding a drill into the bone fragments at the required orientation. The volar plate and guide plate are also preferably provided with mating elements to temporarily stabilize the guide plate on the volar plate during the hole drilling process.
- In use, the volar plate is positioned with its first side against the volar side of the radius and bone screws are inserted through the bone screw holes into the radius to secure the volar plate to the radius. The bone fragments are then aligned and the guide plate is positioned on the second side of the volar plate. A drill, guided by guide holes in the guide plate, drills holes into the bone fragments, and the guide plate is then removed.
- The pegs are then inserted through the peg holes and into the holes in the bone, and the heads of the pegs are threadably engaged in the volar plate. The volar fixation system thereby secures the bone fragments in their proper orientation.
- Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.
-
FIG. 1 is an illustration of an extremity subject to a Colles' fracture; -
FIG. 2 is a top volar view of a right hand volar fixation system according to a first embodiment of the invention; -
FIG. 3 is a side view of a bone peg according to the first embodiment of the volar fixation system of the invention; -
FIG. 4 is a side view of a bone screw of the volar fixation system of the invention; -
FIG. 5 is a side view of the right hand volar plate of the volar fixation system according to the first embodiment of the invention; -
FIG. 6 is a front end view of the right hand volar plate of the volar fixation system according to the first embodiment of the invention; -
FIG. 7 is an exploded side view of the right hand volar plate and guide plate according to the first embodiment of the fixation system of the invention; -
FIG. 8 is a side view of the guide plate positioned on the right hand volar plate to provide drill guide paths in accord with the invention; -
FIG. 9 is an illustration of the first embodiment of the volar fixation system provided in situ aligning and stabilizing a Colles' fracture; -
FIG. 10 is a top volar view of a left hand volar fixation system according to the second embodiment of the invention; -
FIG. 11 is a lateral side view of the left hand volar fixation system according to the second embodiment of the invention; -
FIG. 12 is a bottom view of the left hand volar fixation system according to the second embodiment of the invention; -
FIG. 13 is an enlarged side elevation of a bone peg according to the second embodiment of the volar fixation system of the invention; -
FIG. 14 is a proximal end view of the bone peg ofFIG. 13 ; -
FIG. 15 is first partial top view of the head portion of the left hand volar plate according to the second embodiment of the volar fixation system of the invention; -
FIGS. 16-19 are section views across line 16-16, 17-17, 18-18, and 19-19, respectively inFIG. 15 ; -
FIG. 20 is second partial top view of the head portion of the left hand volar plate according to the second embodiment of the volar fixation system of the invention; and -
FIGS. 21-24 are section views across line 21-21, 22-22, 23-23, and 24-24, respectively inFIG. 20 . - Turning now to
FIGS. 2 through 4 , a first embodiment of avolar fixation system 100 for aligning and stabilizing multiple bone fragments in a Colles' fracture generally includes a substantially rigid T-shapedplate 102 intended to be positioned against the volar side of the radial bone, a plurality of preferably self-tappingbone screws 104 for securing theplate 102 along a non-fractured portion of the radial bone, and a plurality of bone pegs 108 which extend from theplate 102 and into bone fragments of a Colles' fracture. - Referring to
FIGS. 2, 5 and 6, more particularly, the T-shapedplate 102 defines ahead portion 116, anelongate body portion 118 angled relative to the head portion, afirst side 120 which is intended to contact the bone, and asecond side 122 opposite the first side. Thefirst side 120 at the head portion is preferably planar, as is the first side at the body portion. As the head portion and body portion are angled relative to each other, the first side preferably defines two planar portions. The angle Ø between thehead portion 116 and thebody portion 118 is preferably approximately 18° and bent at a radius of approximately 1.00 inch (FIG. 5 ). Thedistal edge 121 of thehead portion 116 is preferably angled proximally toward the medial side at an angle a, e.g., 5°, relative to a line P, which is perpendicular to the body portion. Thehead portion 116 preferably has a width of 0.913 inch and a greatest proximal-distal dimension (i.e., from the corner of angle a to the body portion) of approximately 0.69 inch, and the body portion preferably has a width of 0.375 inch and a length of 1.40 inches. Theplate 102 preferably has a thickness of approximately 0.098 inch. Theplate 102 is preferably made from a titanium alloy, such as Ti-6A-4V. - The
body portion 118 includes three preferably countersunk screw holes 124, 126, 128 for the extension of thebone screws 104 therethrough. Thefirst screw hole 124 has a center preferably 0.235 inch from the end of the body portion, thesecond screw hole 126 has a center preferably 0.630 inch from the end of the body portion, and thethird screw hole 128 is preferably generally elliptical (or oval) and defines foci-like locations at 1.020 inches and 1.050 inches from the end of the body portion. Thehead portion 116 includes four threaded peg holes 130, 132, 134, 136 for individually receiving thepegs 108 therethrough. According to a first preferred aspect of the first embodiment of the invention, the peg holes 130, 132, 134, 136, preferably 0.100 inch in diameter, are preferably non-linearly arranged along thehead portion 116, and are provided such that the adjacent peg holes are provided further distally in a medial to lateral direction along the second side. More particularly, according to a preferred aspect of the first embodiment of the invention, the peg holes are preferably arranged along a parabolic curve, with the center ofpeg hole 130 located approximately 0.321 inch proximal line P and approximately 0.719 inch medial of thelateral edge 137 of the head portion, the center ofpeg hole 132 located approximately 0.296 inch proximal line P and approximately 0.544 inch medial of thelateral edge 137, the center ofpeg hole 134 located approximately 0.250 inch proximal line P and approximately 0.369 inch medial of thelateral edge 137, and the center ofpeg hole 136 located approximately 0.191 inch proximal line P and approximately 0.194 inch medial of thelateral edge 137. - In addition, according to a second preferred aspect of the first embodiment of the invention, the peg holes define axes A1, A2, A3, A4 which are oblique (not parallel) relative to each other, and more preferably are angled in two dimensions (medial/lateral and proximal/distal) relative to each other; i.e., the pegs once inserted into the peg holes are also angled in two dimensions relative to each other. More particularly, the first axis A1 of the first peg hole 130 (that is, the most proximal and medial peg hole) is preferably directed normal to the
first side 120 of thehead portion 116. The axis A2 of theadjacent peg hole 132, i.e., the second axis, is preferably angled approximately 1-7° distal and lateral relative to the first axis A1, and more preferably approximately 2.5° distal and lateral relative to the first axis A1. The axis A3 of thepeg hole 134 laterally adjacent thesecond peg hole 132, i.e., the third axis, is preferably angled approximately 7-13° distal and lateral relative to the first axis A1, and more preferably approximately 10° distal and lateral relative to the first axis A1. The axis A4 of thepeg hole 134 laterally adjacent thethird peg hole 132, i.e., the fourth axis, is preferably angled approximately 10-30° distal and lateral relative to the first axis A1, and more preferably approximately 20° distal and lateral relative to the first axis A1. The second side of thehead portion 116, distal of the peg holes 130, 132, 134, 136 is preferably beveled. - Referring back to
FIG. 3 , thepegs 108, preferably approximately 0.872 inch in length, each have a threadedhead 138 adapted to threadably engage the threads about the peg holes 130, 132, 134, 136, and have a relatively smooth non-threadedcylindrical shaft 140. Theshafts 140 are preferably approximately 0.0675 inch in diameter and 0.765 inch in length. Such dimensions permit the pegs to adequately support the bone fragments such that the bone is able to heal correctly. Thepegs 108 are also preferably made from titanium alloy, and may be coated in a ceramic, e.g., titanium nitride, to provide a bone interface which will not adversely affect bone healing. - Turning now to
FIGS. 7 and 8 , thesystem 100 preferably also includes aguide plate 146 which temporarily sits on thesecond side 122 of thevolar plate 102 and includes guide holes 148, 150, 152, 154 (illustrated in overlapping section inFIG. 8 ) oriented according to the axes A1, A2, A3, A4 of the peg holes for guiding a drill into the bone fragments at the required orientation. That is, the guide holes together with the peg holes define a drill guide path along the axes with sufficient depth to accurately guide a drill (not shown) to drill holes at the desired pin orientations. Thevolar plate 102 and guideplate 146 are also preferably provided with mating elements, such as a plurality ofholes FIG. 2 ), and a plurality ofprotuberances 160 on the mating side of the guide plate (FIG. 7 ), to temporarily stabilize the guide plate on the volar plate during the hole drilling process. - Referring to
FIGS. 2 through 9 , in use, thevolar plate 102 is positioned with itsfirst side 120 against the volar side of the radius. Bone screws 104 (either self-tapping or inserted with the aid of pre-drilled pilot holes) are inserted through the bone screw holes 124, 126, 128 into theradius bone 10 to secure thevolar plate 102 to the radius. The bone fragments 16, 18, 20 are then aligned with theradius 10. Next, theguide plate 146 is positioned on the second side of the volar plate. A drill, guided by a guide path formed by the peg holes and the guide holes, drills holes into and between the bone fragments 16, 18, 20 (and possibly also a portion of the integral radius, depending upon the particular location and extent of the fracture), and the guide plate is then removed. Thepegs 108 are then inserted through the peg holes 130, 132, 134, 136 and into the holes drilled into the fragments, and the heads of the pegs are threadably engaged in the volar plate. Thepegs 108, extending through the oblique-axis peg holes 130, 132, 134, 136, are positioned immediately below the subchondral bone of the radius and support the bone fragments for proper healing. The volar fixation system thereby secures the bone fragments in their proper orientation. - Referring to
FIGS. 10-12 , a second embodiment of avolar plate 210, substantially similar to the first embodiment (with like parts having numbers incremented by 100) and used in substantially the same manner as the first embodiment is shown. Theplate 210 preferably has a length of approximately 2.35 inches, which is approximately 0.35 inch greater than in the first embodiment. This additional length accommodates an extrabone screw hole 229 in the body of the volar plate such that the volar plate preferably includes four bone screw holes 224, 226, 228, 229. The additional bone screw inscrew hole 229 increases plate stability over the three holes of the first embodiment. Theplate 210 preferably tapers in thickness from thebody portion 218 to thehead portion 216. A preferred taper provides aproximal body portion 218 thickness of approximately 0.098 inch andhead portion 216 thickness of approximately 0.078 inch. The taper decreases the thickness of thehead portion 216 relative to the body such that the weight of the volar plate is reduced and an improved tendon clearance is provided. The distal edge of thehead portion 216 has an increased taper (preferably approximately 60° relative to a line normal to the head) to adistal edge 221. Theedge 221 is broken (i.e., made blunt) to prevent irritation or disturbance to the surrounding anatomy. - The
head portion 216 includes four threaded peg holes 230, 232, 234, 236 for individually receivingpegs 208 therethrough (FIGS. 13 and 14 ), and aguide hole 256 for alignment of a guide plate. According to a preferred aspect of the second embodiment of the invention, the peg holes 230, 232, 234, 236, preferably 0.100 inch in diameter, are preferably linearly arranged along thehead portion 216, and are provided such that the adjacent peg holes are provided further distally in a medial to lateral direction along the first and second sides. Referring toFIG. 15 , more particularly, according to a preferred dimensions of the second embodiment of the invention, the center ofpeg hole 230 is located approximately 0.321 inch proximal line P and approximately 0.750 inch medial of thelateral edge 237 of the head portion, the center ofpeg hole 232 is located approximately 0.306 inch proximal line P and 0.557 inch medial of thelateral edge 237, the center ofpeg hole 234 is located approximately 0.289 inch proximal line P and approximately 0.364 inch medial of thelateral edge 237, and the center ofpeg hole 236 is located approximately 0.272 inch proximal line P and approximately 0.171 inch medial of thelateral edge 237. As such, the distance from each of the peg holes to thedistal edge 221 of the volar plate is relatively greater than in the first embodiment, and provides a preferred alignment with respect to the tapereddistal edge 221. - Referring to
FIGS. 15-24 , in addition, as in the first embodiment, the peg holes define axes A1, A2, A3, A4 which are oblique relative to each other, and more preferably are angled in two dimensions (medial/lateral and proximal/distal) relative to each other; i.e., thepegs 208 once inserted into the peg holes are also angled in two dimensions relative to each other. More particularly, as in the first embodiment, the first axis A1 of thefirst peg hole 230 is preferably directed normal (FIGS. 16 and 21 ) to the first side 220 of thehead portion 216. The axis A2 ofpeg hole 232 is preferably angled approximately 1-7° distal (FIG. 17 ) and approximately 1-7° lateral (FIG. 22 ) relative to the axis A1, and more preferably approximately 2.5° both distal and lateral relative to axis A1. The axis A3 ofpeg hole 234 is preferably angled approximately 7-13° distal (FIG. 18 ) and approximately 7-13° lateral (FIG. 23 ) relative to axis A1, and more preferably approximately 10° both distal and lateral relative to axis A1. Axis A4 of thepeg hole 234 is preferably angled approximately 10-30° distal (FIG. 19 ) and approximately 10-30° lateral (FIG. 24 ) relative to axis A1, and more preferably approximately 20° both distal and lateral relative to axis A1. - Referring to
FIGS. 13 and 16 -19, each of the peg holes has a countersunkportion head 238 ofpeg 208.Countersunk portions Countersunk portion 274 is preferably approximately 0.042 inch deep and likewise threaded.Countersunk portion 276 is preferably approximately 0.056 inch deep and also threaded. The respective depths of the countersunk portions are adapted to better accommodate theheads 238 of thepegs 208 relative to the respective axes of the peg holes. - Referring to
FIGS. 13 and 14 , thepegs 208, preferably approximately 0.872 inch in length, each have a threadedhead 238 adapted to threadably engage threads about the peg holes 230, 232, 234, 236, and have a relatively smooth non-threaded cylindrical shaft 240. Theheads 238 preferably include a no. 5thread 280 at a count of 44 per inch. In addition, theheads 238 are rounded and include ahex socket 282 to facilitate stabilized threading into the peg holes. This design accommodates the reduced thickness of the volar plate at thehead portion 216. The shafts 240 are preferably approximately 0.0792 inch (2 mm) in diameter and 0.765 inch in length. Such dimensions permit the pegs to adequately support the bone fragments such that the bone is able to heal correctly. Thepegs 208 are also preferably made from titanium alloy, and may be ‘tiodized’ to provide a strong finish which does not adversely affect bone healing. - There have been described and illustrated herein embodiments of a volar fixation system and a method of aligning and stabilizing a Colles' fracture. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular materials for the elements of the system have been disclosed, it will be appreciated that other materials may be used as well. In addition, while a particular numbers of screw holes in the volar plates and bone screws have been described, it will be understood another number of screw holes and screws may be provided. Further, fewer screws than the number of screw holes may be used to secure to the volar plate to the radius. Also, fewer or more peg holes and bone pegs may be used, preferably such that at least two pegs angled in two dimensions relative to each other are provided. Moreover, while in the first embodiment it is preferred that the peg holes lie along a parabolic curve, it will be appreciated that they can lie along another curve. In addition, while a particular preferred angle between the head portion and body portion has been disclosed, other angles can also be used. Furthermore, while particular distances are disclosed between the peg holes and line P, it will be appreciated that the peg holes may be provided at other distances relative thereto. Moreover, while particular preferred medial/lateral and proximal/distal angles for the peg hole axes has been disclosed, it will be appreciated that yet other angles may be used in accord with the invention. Also, while a right-handed volar plate is described with respect to the first embodiment, and a left-handed volar plate is described with respect to the second embodiment, it will be appreciated that each embodiment may be formed in either a right- or left-handed model, with such alternate models being mirror images of the models described. In addition, aspects from each of the embodiments may be combined. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.
Claims (11)
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US09/524,058 US6364882B1 (en) | 2000-02-01 | 2000-03-13 | Volar fixation system |
US09/735,228 US6440135B2 (en) | 2000-02-01 | 2000-12-12 | Volar fixation system with articulating stabilization pegs |
US10/159,611 US6730090B2 (en) | 2000-02-01 | 2002-05-30 | Fixation device for metaphyseal long bone fractures |
US10/315,787 US6706046B2 (en) | 2000-02-01 | 2002-12-10 | Intramedullary fixation device for metaphyseal long bone fractures and methods of using the same |
US10/762,695 US20040153073A1 (en) | 2000-02-01 | 2004-01-22 | Orthopedic fixation system including plate element with threaded holes having divergent axes |
US11/077,833 US20050159747A1 (en) | 2000-02-01 | 2005-03-11 | Volar fixation system including guide |
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US11/210,593 Expired - Fee Related US7563263B2 (en) | 2000-02-01 | 2005-08-24 | Intramedullary fixation device for metaphyseal long bone fractures |
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US14/101,837 Expired - Lifetime US9480512B2 (en) | 2000-02-01 | 2013-12-10 | Volar fixation system with fixed-angle multi-hole drill guide |
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US15/350,242 Abandoned US20170056082A1 (en) | 2000-02-01 | 2016-11-14 | Volar fixation system including guide |
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US14/101,837 Expired - Lifetime US9480512B2 (en) | 2000-02-01 | 2013-12-10 | Volar fixation system with fixed-angle multi-hole drill guide |
US14/101,786 Expired - Fee Related US9572609B2 (en) | 2000-02-01 | 2013-12-10 | Method of using a volar bone plate on a fracture |
US15/350,242 Abandoned US20170056082A1 (en) | 2000-02-01 | 2016-11-14 | Volar fixation system including guide |
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Also Published As
Publication number | Publication date |
---|---|
US9492213B2 (en) | 2016-11-15 |
US20050283154A1 (en) | 2005-12-22 |
US20130204305A1 (en) | 2013-08-08 |
US20170056082A1 (en) | 2017-03-02 |
US20140128871A1 (en) | 2014-05-08 |
US9480512B2 (en) | 2016-11-01 |
US7563263B2 (en) | 2009-07-21 |
US20140100615A1 (en) | 2014-04-10 |
US8403967B2 (en) | 2013-03-26 |
US20050245931A1 (en) | 2005-11-03 |
US20040153073A1 (en) | 2004-08-05 |
US20100268283A1 (en) | 2010-10-21 |
US9572609B2 (en) | 2017-02-21 |
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