CA2555874C - Anti-splay medical implant closure with multi-surface removal aperture - Google Patents
Anti-splay medical implant closure with multi-surface removal aperture Download PDFInfo
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- CA2555874C CA2555874C CA2555874A CA2555874A CA2555874C CA 2555874 C CA2555874 C CA 2555874C CA 2555874 A CA2555874 A CA 2555874A CA 2555874 A CA2555874 A CA 2555874A CA 2555874 C CA2555874 C CA 2555874C
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- Prior art keywords
- closure
- advancement
- splay
- flange
- structural member
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- Expired - Fee Related
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- 239000007943 implant Substances 0.000 title claims abstract description 49
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 78
- 238000009434 installation Methods 0.000 claims abstract description 42
- 230000013011 mating Effects 0.000 claims abstract description 25
- 230000000295 complement effect Effects 0.000 claims abstract description 12
- 150000001875 compounds Chemical class 0.000 claims description 8
- 238000000926 separation method Methods 0.000 claims description 5
- 238000006243 chemical reaction Methods 0.000 claims description 4
- 230000004044 response Effects 0.000 claims description 4
- 230000006872 improvement Effects 0.000 claims description 2
- 230000007246 mechanism Effects 0.000 description 4
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 230000007480 spreading Effects 0.000 description 2
- 208000010392 Bone Fractures Diseases 0.000 description 1
- 208000032170 Congenital Abnormalities Diseases 0.000 description 1
- 238000004873 anchoring Methods 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000005755 formation reaction Methods 0.000 description 1
- 238000007373 indentation Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
-
- 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
- A61B17/683—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
- F16B23/00—Specially shaped nuts or heads of bolts or screws for rotations by a tool
- F16B23/0092—Specially shaped nuts or heads of bolts or screws for rotations by a tool with a head engageable by two or more different tools
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
- F16B31/00—Screwed connections specially modified in view of tensile load; Break-bolts
- F16B31/02—Screwed connections specially modified in view of tensile load; Break-bolts for indicating the attainment of a particular tensile load or limiting tensile load
- F16B31/021—Screwed connections specially modified in view of tensile load; Break-bolts for indicating the attainment of a particular tensile load or limiting tensile load by means of a frangible part
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
- F16B35/00—Screw-bolts; Stay-bolts; Screw-threaded studs; Screws; Set screws
- F16B35/04—Screw-bolts; Stay-bolts; Screw-threaded studs; Screws; Set screws with specially-shaped head or shaft in order to fix the bolt on or in an object
- F16B35/041—Specially-shaped shafts
- F16B35/044—Specially-shaped ends
- F16B35/047—Specially-shaped ends for preventing cross-threading, i.e. preventing skewing of bolt and nut
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
- A61B17/7076—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
-
- 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
- A61B2017/8655—Pins or screws or threaded wires; nuts therefor with special features for locking in the bone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
- F16B23/00—Specially shaped nuts or heads of bolts or screws for rotations by a tool
- F16B23/0007—Specially shaped nuts or heads of bolts or screws for rotations by a tool characterised by the shape of the recess or the protrusion engaging the tool
- F16B23/003—Specially shaped nuts or heads of bolts or screws for rotations by a tool characterised by the shape of the recess or the protrusion engaging the tool star-shaped or multi-lobular, e.g. Torx-type, twelve-point star
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
- F16B33/00—Features common to bolt and nut
- F16B33/02—Shape of thread; Special thread-forms
Abstract
An anti-splay closure with a multi-surfaced aperture, such as a multi-lobular socket, includes a cylindrical body with an external, continuous, helically extending anti-splay guide and advancement flange and a breakaway installation head. The multi-lobular socket includes a plurality of circumferentiall-y spaced lobes extending parallel to a closure axis of the plug and which circumferentially alternate with spline receiving grooves extending parallel to the closure axis. The closure is used with an open headed bone implant screw having arms that are provided with internal, helically extending mating guide and advancement structures complementary to the body flange to allow slidable mating with the body upon rotation thereof and radial interlocking between the arms and the body.
Description
PATENT
4 Backcrround of the Invention 6 The present invention is directed to a closure for 7 use in closing between spaced arms of a medical implant 8 and securing a rod to the implant. In particular, the 9 closure includes a non-circular mufti-surfaced or multi-lobular internal bore for improved engagement by a 11 complementary shaped tool for purposes of removal and an 12 interlocking helical guide and advancement structure that 13 prevents splaying of upper ends of walls of the implant 14 within which the closure is placed away from an axis of rotation of the closure.
16 Medical implants present a number of problems to 17 both surgeons installing implants and to engineers 18 designing them. It is always desirable to have an 19 implant that is strong and unlikely to fail or break during usage. It is also desirable for the implant to be 21 as small and lightweight as possible so that it is less 22 intrusive on the patient. These are normally conflicting 23 goals, and often difficult to resolve.
1 One particular type of implant presents special 2 problems. In particular, spinal bone screws, hooks, etc.
3 are used in many types of back surgery for repair of 4 injury, disease or congenital defect. For example, spinal bone screws of this type are designed to have one 6 end that inserts threadably into a vertebra and a head at 7 an opposite end. The head is designed to receive a rod 8 or rod-like member in a channel in the head in which the 9 rod is both captured and locked to prevent relative movement between the various elements subsequent to 11 installation. The channel in the head is open ended and 12 the rod is simply laid in the open channel. The channel 13 is then closed with a closure member. The open headed 14 bone screws and related devices are much easier to use and in some situations must be used instead of closed 16 headed devices.
17 While open headed devices are often necessary and 18 often preferred for usage, there is a significant problem 19 associated with them. In particular, the open headed devices conventionally have two upstanding arms that are 21 on opposite sides of a channel that receives the rod 22 member. The top of the channel is closed by a closure 23 after the rod member is placed in the channel. The 24 closure can be of a slide in type, but such are not easy to use. Threaded nuts are sometimes used that go around 26 the outside of the arms. Such nuts prevent splaying of 1 the arms, but nuts substantially increase the size and 2 profile of the implant which is not desirable. Many open 3 headed implants are closed by plugs, bodies or closures 4 that screw into threads between the arms, because such have a low profile. However, threaded plugs have 6 encountered problems also in that they produce radially 7 outward directed forces that lead to splaying or 8 spreading of the tops of the arms or at least do not 9 prevent splaying caused by outside forces that in turn loosen the implant. In particular, in order to lock the 11 rod member in place, a significant force must be exerted 12 on the relatively small plug. The tightening forces are 13 required to provide enough torque to insure that the rod 14 member is clamped or locked in place relative to the bone screw, so that the rod does not move axially or 16 rotationally therein. Torques on the order of 100 inch-17 pounds are typical.
18 Because open headed implants such as bone screws, 19 hooks and the like are relatively small, the arms that extend upwardly at the head can rotate relative to the 21 base that holds the arms so that the tops of the arms are 22 rotated or bent outward relatively easily by radially 23 outward directed forces due to the application of 24 substantial forces required to secure the rod member.
Historically, early closures were simple plugs that were 26 threaded with V-shaped threads and screwed into mating 1 threads on the inside of each of the arms. But, as noted 2 above, conventional V-shaped threaded plugs tend to splay 3 or push the arms radially outward upon the application of 4 a significant amount of torque, which ends up bending the arms sufficiently to allow the threads to loosen or 6 disengage and the closure to fail. To counter outward 7 directed application of forces, various engineering 8 techniques were applied to resist the spreading forces.
9 For example, the arms were significantly strengthened by substantially increasing the width of the arms. This had 11 the unfortunate effect of substantially increasing the 12 weight and the profile of the implant, which was 13 undesirable.
14 The tendency of the open headed bone screw to splay is a result of the geometry or contour of the threads 16 typically employed in such devices. In the past, most 17 bone screw head receptacles and screw plugs have employed 18 V-shaped threads. V-threads have leading and trailing 19 sides oriented at angles to the screw axis. Thus, torque on the plug is translated to the bone screw head at least 21 partially in an axial outward direction, tending to push 22 or splay the arms of the bone screw head radially 23 outward. This in turn spreads the internally threaded 24 receptacle away from the thread axis so as to loosen the plug in the receptacle. The threads also have smooth or 26 linear surfaces in a radial direction that allow slippage 1 along the surfaces since they at best fit interferingly 2 with respect to each other and have in the past not 3 interlocked together. Thus, forces other than insertion 4 forces can act to easily splay the arms since the surfaces slide rather than interlock.
6 The radial expansion problem of V-threads due to the 7 radial outward component of forces applied to a V-thread 8 has been recognized in various types of threaded joints.
9 To overcome this problem, so-called "buttress"
threadforms were developed. In a buttress thread, the 11 trailing or thrust surface is oriented perpendicular to 12 the thread axis, while the leading or clearance surface 13 remains angled. This theoretically results in no 14 radially inward or outward directed forces of a threaded receptacle in reaction to application of torque on the 16 threaded plug. However, the linear surfaces still allow 17 sideways slippage, if other forces are applied to the 18 arms.
19 Development of threadforms proceeded from buttress threadforms which in theory have a neutral radial force 21 effect on the screw receptacle, to reverse angled 22 threadforms which theoretically positively draw the 23 threads of the receptacle radially inward toward the 24 thread axis when the plug is torqued. In a reverse angle threadform, the trailing side of the external thread is 26 angled toward the thread axis instead of away from the 1 thread axis, as in conventional V-threads. While 2 buttress and reverse threadforms reduce the tendency to 3 splay, the surfaces are not interlocking and the arms can 4 still be bent outward by forces acting on the implant.
The threads can be distorted or bent by forces exerted 6 during installation. Therefore, while these types of 7 threadforms are designed to not exert radial forces 8 during installation, at most such threadforms provide an 9 interference or frictional fit and do not positively lock the arms in place relative to the closure plug.
11 Furthermore, it is noted that plugs of this type 12 that use threadforms are often cross threaded. That is, 13 as the surgeon tries to start the threaded plug into the 14 threaded receiver, the thread on the plug is inadvertently started in the wrong turn or pass of the 16 thread on one arm. This problem especially occurs 17 because the parts are very small and hard to handle.
18 When cross threading occurs, the plug will often screw 19 part way in the receiver and then "lock up" so that the surgeon is led to believe that the plug is tight and 21 properly set. However, the rod is not secure relative to 22 the bone screw or other implant and the implant fails to 23 function properly. Therefore, it is also desirable to 24 have a closure that resists cross threading in the receiver.
1 As stated above, it is desirable for medical 2 implants to have strong and secure elements which are 3 also very lightweight and low profile so that the overall 4 implant impacts as little as possible upon the patient.
However, strong and secure are somewhat divergent goals 6 from the goals of lightweight and low profile. Thus, 7 size, weight, and profile must all be taken into 8 consideration and minimized, as much as possible, 9 consistent with effective functioning.
In order to provide sufficient strength and friction 11 to resist movement of the various elements once the 12 closure plug is seated, it is necessary to apply a fairly 13 substantial amount of torque to the closure. While some 14 closure plugs are torqued without a head, many of the closure plugs currently in use in medical implants have a 16 driving or installation head that breaks away from the 17 remainder of the fastener at a preselected torque in 18 order to assure that the closure is sufficiently torqued 19 to provide the necessary strength and locking friction.
The head is also broken away in order to assure that the 21 closure is not over-torqued. Further, the head is 22 typically broken away in order to provide the low profile 23 and light weight that is desired in such closure plugs.
24 Because the driving head is typically broken away and because it is sometimes necessary to remove the 26 closure after implantation and setting thereof, some 1 mechanism must be provided in order to securely engage 2 and remove the closure. Various structures have been 3 provided for this purpose in prior art devices. The 4 prior art structures have had varying degrees of success, but have typically been most effective in fasteners 6 having a diameter that is comparatively large, such as 9 7 to 12 millimeters, because such larger fasteners provide 8 greater surface and volume for engagement by removal 9 structure of one kind or another. However, it is desirable to provide an implant closure plug with a 11 removal mechanism which works effectively with implant 12 elements of even smaller size.
14 Summary of the Invention 16 The present invention provides a closure for use 17 particularly with an open-headed bone implant screw to 18 secure another implant structural member therein. The 19 closure has a cylindrical plug, base or body and a driving or installation head that is separable from the 21 body at a preselected torque at a breakaway region or 22 along a breakaway line. A non-circular multi-surfaced 23 bore or aperture extends axially through the head and 24 into the body and is accessible subsequent to break off of the installation head to form a structure or mechanism 26 for engagement by a removal tool of similar cross section 1 to remove the body from the bone screw, if necessary. As 2 used herein, the term mufti-surfaced is intended to 3 include mufti-lobular or any other horizontal cross 4 section (relative to the drawings) that is not round and that is adapted to mate with an insertion tool or removal 6 tool, so as to provide grip or purchase to the tool while 7 the tool rotates about an axis of rotation of the closure 8 so as to operably install and set the closure or 9 alternatively to remove the closure upon reverse rotation of the tool. In particular, within the body of the 11 closure, the removal aperture is formed into a non-round 12 mufti-surfaced socket to receive a closure removal tool 13 having a non-round cross sectional shape which is 14 complementary to the shape of the socket. As noted above, the socket has a horizontal cross section or 16 footprint that is non-round so that after a tool of 17 similar cross section is placed in the aperture, an 18 interference fit is provided when the tool is rotated, so 19 as to rotate the body.
The mufti-surfaced socket of the aperture is 21 preferably formed by a plurality of centrally facing 22 surfaces positioned circumferentially about a socket axis 23 and extending generally parallel to the axis that is 24 coaxial with an axis of rotation of the body. Such surfaces may include a plurality of planar surfaces, such 26 as or similar to a hexagonal Allen socket, or non-planar 1 surfaces including or similar to Torx (trademark of 2 Textron, Inc.) or other mufti-lobular shapes. A multi-3 lobular shape preferably includes a plurality of 4 circumferentially spaced, centrally facing, rounded lobes separated by axial grooves or channels which receive 6 splines of the closure removal tool. The splines of the 7 removal tool are circumferentially spaced and separated 8 by axially extending, rounded, outwardly facing concave 9 grooves which are shaped to closely engage the lobes of a matingly shaped closure socket. The shapes of the 11 closure socket and closure removal tool provide for 12 positive, non-slip engagement of the removal tool with 13 the closure body while avoiding the localized 14 concentrations of stresses which can occur with other configurations of separable torque transfer arrangements.
16 The closure is also provided with a non-threaded 17 guide and advancement structure for securing the closure 18 in a receiver and locking the arms against splaying once 19 the closure is seated in the implant. Preferably, the receiver is a rod receiving channel of an open-headed 21 bone screw, hook or other medical implant in which the 22 channel has an open top and is located between two spaced 23 apart arms forming the open head of the bone screw.
24 The body of the closure is cylindrical and has an external guide and advancement flange extending helically 26 about the body, relative to the body axis of rotation.
1 The guide and advancement flange preferably has a 2 compound, anti-splay type of contour which cooperates 3 with complementary internal mating guide and advancement 4 structures formed into the inner surfaces of spaced apart arms forming the open head of the bone implant screw.
6 The flange has such a compound contour that includes an 7 inward anti-splay surface component on the flange which 8 faces generally inward toward the body axis. The mating 9 guide and advancement structures of the bone screw head have a complementary contour to the body flange including 11 outward anti-splay surface components which face outward, 12 generally away from the body axis.
13 The inward anti-splay surface component is 14 preferably formed by an enlarged region near an outer periphery of the body flange near a crest of the flange.
16 The outward anti-splay surface components are formed near 17 an outer periphery of the mating guide and advancement 18 structures by enlargement thereof. The complementary 19 anti-splay surface components of the closure and head slidably engage upon rotation and cooperate to interlock 21 the body with the arms so as to resist splaying 22 tendencies of the arms when the closure is strongly 23 torqued or when other forces are applied to the various 24 elements thereof.
In use, the closure and open-headed bone screw are 26 used to anchor a spinal fixation member, such as a rod, 1 by threadedly implanting the bone screw into a bone and 2 clamping the rod within the head of the bone screw using 3 the closure body. In order to enhance clamping 4 engagement of the rod, the body may be provided with structural features which cut into the surface of the rod 6 to thereby reduce the likelihood of translational or 7 rotational movement of the rod relative to the bone 8 screw. The body is preferably provided with a ~~cup 9 point", set ring, or V-ring on a forward end of the body to cut into the surface of the rod when the body is 11 tightly torqued into the head of the bone screw. In some 12 embodiments, the body is also provided with a central 13 axial point on the leading end thereof.
Objects and Advantages of the Invention 17 Therefore, objects of the present invention include 18 providing an improved closure for use with an open headed 19 bone screw; providing such a closure having a cylindrical base or body and a driving or installation head that 21 breaks away from the body at a breakaway region to 22 provide a low or minimized profile subsequent to 23 installation of the closure; providing such a closure 24 having removal structure enabling positive, non-slip engagement of the closure by a removal tool; providing 26 such a closure having an axially extending bore that 1 passes through the installation head; providing such a 2 closure having a removal aperture that is mufti-surfaced 3 and forms a removal tool receiving socket including a 4 plurality of centrally facing surfaces positioned circumferentially about an axis of rotation of the body 6 and extending generally along the axis to form the non-? round, non-slip socket to receive a removal tool having a 8 complementary shape; providing such a closure which has 9 such a removal aperture with a mufti-lobular shape including a plurality of circumferentially spaced, 11 centrally facing, rounded lobes separated by axial 12 grooves or channels which receive splines of the removal 13 tool; providing such a closure wherein the removal socket 14 becomes fully accessible to a removal tool when the installation head breaks from the body; providing such a 16 closure in combination with an open headed bone implant 17 screw for use in anchoring a bone fixation structural 18 member, such as a rod; providing such a combination in 19 which the open headed bone screw includes a pair of spaced apart arms forming a rod receiving channel;
21 providing such a combination including an external guide 22 and advancement flange on the closure body and internal 23 mating guide and advancement structures located on inner 24 surfaces of the bone screw head which slidably mate upon rotation of the body and that interlock and cooperate to 26 resist tendencies of the arms to splay or diverge when 1 the closure is torqued tightly into clamping engagement 2 with a rod positioned in the channel or when external 3 forces are applied to the implant; providing such a 4 combination including elements to enhance setting engagement of the closure body with a rod in the bone 6 screw channel; providing such a combination in which a 7 forward end of the closure body is provided with a an 8 axially aligned point and/or peripheral cup point or V-9 ring to cut into the surface of the rod when the body is torqued and tightened, to resist translational and 11 rotational movement of the rod relative to the bone 12 screw; and providing such an anti-splay closure body with 13 a mufti-surface aperture which is economical to 14 manufacture, which is secure and efficient in use, and which is particularly well adapted for its intended 16 purpose.
17 It is a further object of the invention that a 18 closure for setting engagement with a structural member 19 and comprising a substantially cylindrical body having an outer cylindrical surface relative to a central closure 21 axis; a substantially continuous guide and advancement 22 flange extending helically about said outer cylindrical 23 surface, said flange having a leading surface and a 24 trailing surface relative to a direction of forward advancement; at least one of said leading surface or said 26 trailing surface being compound in contour and including 1 an inward facing anti-splay surface component facing 2 generally toward said closure axis; said body having a 3 mufti-surface aperture formed therein that is aligned 4 with said closure axis and that is elongated along said closure axis, said aperture opening onto a trailing 6 surface of said body and including a plurality of 7 circumferentially spaced, centrally facing surfaces 8 extending substantially parallel to said closure axis 9 that are aligned to form a removal socket adapted to receive a removal tool; and a break off installation 11 head.
12 It is a still further object of the invention that a 13 closure for setting engagement with a structural member 14 and comprising a substantially cylindrical body having an outer cylindrical surface relative to a central closure 16 axis; a guide and advancement flange extending helically 17 about said outer cylindrical surface, said flange having 18 a trailing surface relative to said forward advancement 19 direction; said trailing surface being compound in contour and including an inward facing anti-splay surface 21 component facing generally toward said closure axis; said 22 body having a mufti-lobular aperture formed therein which 23 is aligned on and elongated along said closure axis, said 24 aperture including a plurality of circumferentially spiced lobes extending substantially parallel to said 26 closure axis and said lobes circumferentially alternating 1 with bore grooves extending substantially parallel to 2 said closure axis to form a removal socket adapted to 3 receive a removal tool; and a break off installation 4 head.
It is a still further object of the invention that a 6 closure for setting engagement with a structural member 7 and including a substantially cylindrical body having an 8 outer cylindrical surface relative to a central closure 9 axis and a substantially continuous guide and advancement flange extending helically about said outer cylindrical 11 surface, said flange having a leading surface and a 12 trailing surface relative to a direction of forward 13 advancement, the improvement comprising at least one of 14 said leading surface and said trailing surface being compound in contour and including an inward facing anti-16 splay surface component facing generally toward said 17 closure axis; said body having a mufti-surfaced aperture 18 formed therein which is located and elongated along said 19 closure axis, said aperture including a plurality of circumferentially spaced surfaces extending substantially 21 parallel to said closure axis so as to form a removal 22 socket adapted to receive a removal tool; and a break off 23 installation head.
24 Other objects and advantages of this invention will become apparent from the following description taken in 26 conjunction with the accompanying drawings wherein are 1 set forth, by way of illustration and example, certain 2 embodiments of this invention.
3 The drawings constitute a part of this 4 specification, include exemplary embodiments of the present invention, and illustrate various objects and 6 features thereof.
8 Brief Description of the Drawings Fig. 1 is an enlarged perspective view of an anti-11 splay closure with a mufti-surfaced removal aperture in 12 accordance with the present invention.
13 Fig. 2 is a side elevational view of the closure at 14 a further enlarged scale.
Fig. 3 is a top plan view of the closure and 16 illustrates details of the mufti-surfaced aperture of the 17 closure with the installation head in place.
18 Fig. 4 is a bottom plan view of the closure and 19 illustrates a V-ring on a forward end of the closure.
Fig. 5 is a cross sectional view of the closure, 21 taken on line 5-5 of Fig. 3, and illustrates internal 22 details of the mufti-surfaced aperture of the closure.
23 Fig. 6 is a fragmentary side elevational view at a 24 reduced scale of the closure in combination with an open headed bone implant screw in a vertebra.
1 Fig. 7 is a view similar to Fig. 6 of the closure 2 and screw and illustrates separation of the breakaway 3 installation head from a body of the closure.
4 Fig. 8 is an enlarged cross sectional view of the body of the present invention positioned in clamping 6 relationship within an open headed bone screw and 7 illustrates details of an anti-splay guide and 8 advancement structure of the body and bone screw head.
9 Fig. 9 is an enlarged top plan view of the closure within the open headed bone screw with the installation 11 head removed.
13 Detailed Description of the Invention As required, detailed embodiments of the present 16 invention are disclosed herein; however, it is to be 17 understood that the disclosed embodiments are merely 18 exemplary of the invention, which may be embodied in 19 various forms. Therefore, specific structural and functional details disclosed herein are not to be 21 interpreted as limiting, but merely as a basis for the 22 claims and as a representative basis for teaching one 23 skilled in the art to variously employ the present 24 invention in virtually any appropriately detailed structure.
1 Referring to the drawings in more detail, the 2 reference numeral 1 generally designates an anti-splay 3 closure with a mufti-surfaced aperture, such as a multi-4 lobular aperture 2. The closure 1 generally includes a body 4 and a breakaway installation head 6. The body 4 6 is used in cooperation with an open headed bone implant 7 screw 8 (Figs. 6 and 7) to form an implant anchor 8 assembly 9 to secure or anchor a spinal fixation member 9 or rod 10 with respect to a bone 12, such as a vertebra.
The bone screw 8 includes a threaded shank 14 for 11 threadably implanting into the bone 12 and an open head 12 16 formed by a pair of spaced apart arms 18 defining a U-13 shaped channel 20 therebetween to receive the rod 10.
14 Inner and facing surfaces of the arms 18 have internal mating grooves or guide and advancement structures 22 16 (Fig. 8) tapped, or otherwise formed, therein. The head 17 16 has tool grip indentations 23 (Fig. 8) that allow a 18 gripping tool (not shown) to securely hold the head 16 19 and facilitate gripping the bone screw 8 during manipulation for implantation of the bone screw 8 into 21 the bone 12.
22 The body 4 is cylindrical in external shape about an 23 axis of rotation 25 (Fig. 7) and has a forward, leading, 24 or inner end 27 and a rear, trailing, or outer end 28.
The breakaway head 6 is connected to the body 4 at the 26 rear end 28 by way of a weakened breakaway line or ring 1 30 formed by selectively reducing the wall thickness to 2 weaken the region. The breakaway ring 30 is thinned in 3 such a manner that it fails at a selected relative torque 4 between the head 6 and the body 4, as a result of torque applied to the head 6 to tighten the body 4 within the 6 bone screw 8. As illustrated, the breakaway head 6 has a 7 hexagonal outer shape to facilitate non-slip engagement 8 by an installation tool (not shown) of a conventional 9 socket type. The head 6 may also be provided with a set of tool slots 32 for alternative or more positive non-11 slip engagement of the head 6 by the installation tool 12 and has a central bore 31 with an upper chamfer 33.
13 Separation of the head 6 from the body 4, as shown in 14 Fig. 7, is desirable to control or limit torque applied by the body 4 to the rod 10 within the bone screw head I6 16 and to provide a low profile joint between the body 4 and 17 the bone screw 8.
18 The body 4 is provided with a guide and advancement 19 flange 35 which extends helically about the cylindrical closure body 4. The flange 35 is enlarged near an outer 21 periphery or radial crest thereof to form a generally 22 inwardly facing or inward anti-splay surface 37. In a 23 similar manner, the mating guide and advancement 24 structures 22 are enlarged near the radially outward peripheries thereof to form generally outwardly facing or 26 outward anti-splay surfaces 39. The anti-splay or splay 1 resisting surfaces 37 and 39 mutually engage or slide 2 closely relative to one another when the body 4 is 3 rotated and thereby advanced into the bone screw head 16 4 so as to interlock thereby also interlocking the body 4 to the arms 18 to resist or prevent outward splaying of 6 the arms 18 in reaction to torque or other forces.
7 Although particular contours of the flange 35 and 8 mating structures 22 are shown herein, other contours of 9 anti-splay guide and advancement flanges 35 and mating structures 22 are foreseen. Examples of such alternative 11 configurations of anti-splay or splay resisting guide and 12 advancement flange and mating structures are disclosed in 13 U.S. Patent application, Serial No. 10/236,123 which is 14 now U.S. Patent No.6,726,689, and which is incorporated herein by reference. The flange 35 and mating structures 16 22 cooperate to guide and advance the body 4 into 17 clamping engagement with the rod 10 within the channel 20 18 in response to clockwise rotation of the body 4.
19 In order to more positively secure the rod 10 within the head 16 of the bone screw 8, the body 4 is provided 21 with a V-ring or "cup point" 42 on the inner or forward 22 end 27 thereof. The V-ring 42 cuts into the surface of 23 the rod 10 when the body 4 is tightly torqued into the 24 head 16. The V-ring 42 extends about a periphery of the inner end 27 of the body 4 and, thus, provides two 1 possible areas of engagement between the body 4 and the 2 rod 10.
3 In the great majority of cases, the body 4 is 4 torqued into engagement with the rod 10 in the bone screw 8, the installation head 6 is broken away, and the anchor 6 assembly 9 is permanently implanted in the bone 12.
7 However, spinal alignment geometry is complex and it is 8 sometimes necessary 9 to make adjustments to a spinal fixation system.
Additionally, slippage or failure of spinal fixation 11 components can occur due to injury to the patient, 12 deterioration of bone tissue, or the like. It is also 13 possible that an implant system using anchored rods might 14 be used therapeutically, for example, to set a broken bone, and 16 subsequently removed. For these reasons, implant anchor 17 assemblies often provide structures or mechanisms for 18 releasing an anchor assembly 9 to make such adjustments 19 or changes in a spinal fixation system. The anchor assembly 9 of the present invention provides formations 21 for engaging the body 4 to retract it out of the bone 22 screw head 16 to release the rod 10 to enable adjustment 23 of the position of the rod 10 relative to the bone screw 24 8.
The mufti-surfaced aperture 2 is coaxially 26 positioned relative to the body 4 axis of rotation 25 and 1 provided for non-slip engagement by a closure removal 2 tool (not shown) having a shape which is complementary to 3 the shape of the aperture 2. The illustrated aperture 2 4 is multi-lobular and is formed by a plurality of circumferentially spaced, axially extending lobes 45 6 separated by intervening spline receiving grooves 47.
7 The closure removal tool (not shown) for engagement with 8 the aperture 2 has a shape which is complementary thereto 9 and includes circumferentially spaced splines corresponding to the grooves 47 and removal tool grooves 11 corresponding to the lobes 45. The aperture 2 may be of 12 a Torx type shape which is ~~hexlobular" or six lobed, or 13 other mufti- lobular shape.
14 It is also foreseen that the mufti-surfaced aperture 2 could be a simpler shape, such as a mufti-faceted shape 16 having a square, triangular, rectangular, etc. shape.
17 Such a mufti-faceted shape could include a hexagonal 18 Allen type socket (not shown) and an appropriately shaped 19 closure removal tool (not shown). Alternatively, other non-circular, mufti-surfacedshapes are envisioned for 21 the shape of the aperture however, the axis 25 passes 2;
22 through the perture 2 so to facilitate rotation of a as 23 the body 4 a tool having a single mating projection by 24 that conforms to the aperture 2.
It is to be understood that while certain forms of 26 the present invention have been illustrated and described 1 herein, it is not to be limited to the specific forms or 2 arrangement of parts described and shown.
16 Medical implants present a number of problems to 17 both surgeons installing implants and to engineers 18 designing them. It is always desirable to have an 19 implant that is strong and unlikely to fail or break during usage. It is also desirable for the implant to be 21 as small and lightweight as possible so that it is less 22 intrusive on the patient. These are normally conflicting 23 goals, and often difficult to resolve.
1 One particular type of implant presents special 2 problems. In particular, spinal bone screws, hooks, etc.
3 are used in many types of back surgery for repair of 4 injury, disease or congenital defect. For example, spinal bone screws of this type are designed to have one 6 end that inserts threadably into a vertebra and a head at 7 an opposite end. The head is designed to receive a rod 8 or rod-like member in a channel in the head in which the 9 rod is both captured and locked to prevent relative movement between the various elements subsequent to 11 installation. The channel in the head is open ended and 12 the rod is simply laid in the open channel. The channel 13 is then closed with a closure member. The open headed 14 bone screws and related devices are much easier to use and in some situations must be used instead of closed 16 headed devices.
17 While open headed devices are often necessary and 18 often preferred for usage, there is a significant problem 19 associated with them. In particular, the open headed devices conventionally have two upstanding arms that are 21 on opposite sides of a channel that receives the rod 22 member. The top of the channel is closed by a closure 23 after the rod member is placed in the channel. The 24 closure can be of a slide in type, but such are not easy to use. Threaded nuts are sometimes used that go around 26 the outside of the arms. Such nuts prevent splaying of 1 the arms, but nuts substantially increase the size and 2 profile of the implant which is not desirable. Many open 3 headed implants are closed by plugs, bodies or closures 4 that screw into threads between the arms, because such have a low profile. However, threaded plugs have 6 encountered problems also in that they produce radially 7 outward directed forces that lead to splaying or 8 spreading of the tops of the arms or at least do not 9 prevent splaying caused by outside forces that in turn loosen the implant. In particular, in order to lock the 11 rod member in place, a significant force must be exerted 12 on the relatively small plug. The tightening forces are 13 required to provide enough torque to insure that the rod 14 member is clamped or locked in place relative to the bone screw, so that the rod does not move axially or 16 rotationally therein. Torques on the order of 100 inch-17 pounds are typical.
18 Because open headed implants such as bone screws, 19 hooks and the like are relatively small, the arms that extend upwardly at the head can rotate relative to the 21 base that holds the arms so that the tops of the arms are 22 rotated or bent outward relatively easily by radially 23 outward directed forces due to the application of 24 substantial forces required to secure the rod member.
Historically, early closures were simple plugs that were 26 threaded with V-shaped threads and screwed into mating 1 threads on the inside of each of the arms. But, as noted 2 above, conventional V-shaped threaded plugs tend to splay 3 or push the arms radially outward upon the application of 4 a significant amount of torque, which ends up bending the arms sufficiently to allow the threads to loosen or 6 disengage and the closure to fail. To counter outward 7 directed application of forces, various engineering 8 techniques were applied to resist the spreading forces.
9 For example, the arms were significantly strengthened by substantially increasing the width of the arms. This had 11 the unfortunate effect of substantially increasing the 12 weight and the profile of the implant, which was 13 undesirable.
14 The tendency of the open headed bone screw to splay is a result of the geometry or contour of the threads 16 typically employed in such devices. In the past, most 17 bone screw head receptacles and screw plugs have employed 18 V-shaped threads. V-threads have leading and trailing 19 sides oriented at angles to the screw axis. Thus, torque on the plug is translated to the bone screw head at least 21 partially in an axial outward direction, tending to push 22 or splay the arms of the bone screw head radially 23 outward. This in turn spreads the internally threaded 24 receptacle away from the thread axis so as to loosen the plug in the receptacle. The threads also have smooth or 26 linear surfaces in a radial direction that allow slippage 1 along the surfaces since they at best fit interferingly 2 with respect to each other and have in the past not 3 interlocked together. Thus, forces other than insertion 4 forces can act to easily splay the arms since the surfaces slide rather than interlock.
6 The radial expansion problem of V-threads due to the 7 radial outward component of forces applied to a V-thread 8 has been recognized in various types of threaded joints.
9 To overcome this problem, so-called "buttress"
threadforms were developed. In a buttress thread, the 11 trailing or thrust surface is oriented perpendicular to 12 the thread axis, while the leading or clearance surface 13 remains angled. This theoretically results in no 14 radially inward or outward directed forces of a threaded receptacle in reaction to application of torque on the 16 threaded plug. However, the linear surfaces still allow 17 sideways slippage, if other forces are applied to the 18 arms.
19 Development of threadforms proceeded from buttress threadforms which in theory have a neutral radial force 21 effect on the screw receptacle, to reverse angled 22 threadforms which theoretically positively draw the 23 threads of the receptacle radially inward toward the 24 thread axis when the plug is torqued. In a reverse angle threadform, the trailing side of the external thread is 26 angled toward the thread axis instead of away from the 1 thread axis, as in conventional V-threads. While 2 buttress and reverse threadforms reduce the tendency to 3 splay, the surfaces are not interlocking and the arms can 4 still be bent outward by forces acting on the implant.
The threads can be distorted or bent by forces exerted 6 during installation. Therefore, while these types of 7 threadforms are designed to not exert radial forces 8 during installation, at most such threadforms provide an 9 interference or frictional fit and do not positively lock the arms in place relative to the closure plug.
11 Furthermore, it is noted that plugs of this type 12 that use threadforms are often cross threaded. That is, 13 as the surgeon tries to start the threaded plug into the 14 threaded receiver, the thread on the plug is inadvertently started in the wrong turn or pass of the 16 thread on one arm. This problem especially occurs 17 because the parts are very small and hard to handle.
18 When cross threading occurs, the plug will often screw 19 part way in the receiver and then "lock up" so that the surgeon is led to believe that the plug is tight and 21 properly set. However, the rod is not secure relative to 22 the bone screw or other implant and the implant fails to 23 function properly. Therefore, it is also desirable to 24 have a closure that resists cross threading in the receiver.
1 As stated above, it is desirable for medical 2 implants to have strong and secure elements which are 3 also very lightweight and low profile so that the overall 4 implant impacts as little as possible upon the patient.
However, strong and secure are somewhat divergent goals 6 from the goals of lightweight and low profile. Thus, 7 size, weight, and profile must all be taken into 8 consideration and minimized, as much as possible, 9 consistent with effective functioning.
In order to provide sufficient strength and friction 11 to resist movement of the various elements once the 12 closure plug is seated, it is necessary to apply a fairly 13 substantial amount of torque to the closure. While some 14 closure plugs are torqued without a head, many of the closure plugs currently in use in medical implants have a 16 driving or installation head that breaks away from the 17 remainder of the fastener at a preselected torque in 18 order to assure that the closure is sufficiently torqued 19 to provide the necessary strength and locking friction.
The head is also broken away in order to assure that the 21 closure is not over-torqued. Further, the head is 22 typically broken away in order to provide the low profile 23 and light weight that is desired in such closure plugs.
24 Because the driving head is typically broken away and because it is sometimes necessary to remove the 26 closure after implantation and setting thereof, some 1 mechanism must be provided in order to securely engage 2 and remove the closure. Various structures have been 3 provided for this purpose in prior art devices. The 4 prior art structures have had varying degrees of success, but have typically been most effective in fasteners 6 having a diameter that is comparatively large, such as 9 7 to 12 millimeters, because such larger fasteners provide 8 greater surface and volume for engagement by removal 9 structure of one kind or another. However, it is desirable to provide an implant closure plug with a 11 removal mechanism which works effectively with implant 12 elements of even smaller size.
14 Summary of the Invention 16 The present invention provides a closure for use 17 particularly with an open-headed bone implant screw to 18 secure another implant structural member therein. The 19 closure has a cylindrical plug, base or body and a driving or installation head that is separable from the 21 body at a preselected torque at a breakaway region or 22 along a breakaway line. A non-circular multi-surfaced 23 bore or aperture extends axially through the head and 24 into the body and is accessible subsequent to break off of the installation head to form a structure or mechanism 26 for engagement by a removal tool of similar cross section 1 to remove the body from the bone screw, if necessary. As 2 used herein, the term mufti-surfaced is intended to 3 include mufti-lobular or any other horizontal cross 4 section (relative to the drawings) that is not round and that is adapted to mate with an insertion tool or removal 6 tool, so as to provide grip or purchase to the tool while 7 the tool rotates about an axis of rotation of the closure 8 so as to operably install and set the closure or 9 alternatively to remove the closure upon reverse rotation of the tool. In particular, within the body of the 11 closure, the removal aperture is formed into a non-round 12 mufti-surfaced socket to receive a closure removal tool 13 having a non-round cross sectional shape which is 14 complementary to the shape of the socket. As noted above, the socket has a horizontal cross section or 16 footprint that is non-round so that after a tool of 17 similar cross section is placed in the aperture, an 18 interference fit is provided when the tool is rotated, so 19 as to rotate the body.
The mufti-surfaced socket of the aperture is 21 preferably formed by a plurality of centrally facing 22 surfaces positioned circumferentially about a socket axis 23 and extending generally parallel to the axis that is 24 coaxial with an axis of rotation of the body. Such surfaces may include a plurality of planar surfaces, such 26 as or similar to a hexagonal Allen socket, or non-planar 1 surfaces including or similar to Torx (trademark of 2 Textron, Inc.) or other mufti-lobular shapes. A multi-3 lobular shape preferably includes a plurality of 4 circumferentially spaced, centrally facing, rounded lobes separated by axial grooves or channels which receive 6 splines of the closure removal tool. The splines of the 7 removal tool are circumferentially spaced and separated 8 by axially extending, rounded, outwardly facing concave 9 grooves which are shaped to closely engage the lobes of a matingly shaped closure socket. The shapes of the 11 closure socket and closure removal tool provide for 12 positive, non-slip engagement of the removal tool with 13 the closure body while avoiding the localized 14 concentrations of stresses which can occur with other configurations of separable torque transfer arrangements.
16 The closure is also provided with a non-threaded 17 guide and advancement structure for securing the closure 18 in a receiver and locking the arms against splaying once 19 the closure is seated in the implant. Preferably, the receiver is a rod receiving channel of an open-headed 21 bone screw, hook or other medical implant in which the 22 channel has an open top and is located between two spaced 23 apart arms forming the open head of the bone screw.
24 The body of the closure is cylindrical and has an external guide and advancement flange extending helically 26 about the body, relative to the body axis of rotation.
1 The guide and advancement flange preferably has a 2 compound, anti-splay type of contour which cooperates 3 with complementary internal mating guide and advancement 4 structures formed into the inner surfaces of spaced apart arms forming the open head of the bone implant screw.
6 The flange has such a compound contour that includes an 7 inward anti-splay surface component on the flange which 8 faces generally inward toward the body axis. The mating 9 guide and advancement structures of the bone screw head have a complementary contour to the body flange including 11 outward anti-splay surface components which face outward, 12 generally away from the body axis.
13 The inward anti-splay surface component is 14 preferably formed by an enlarged region near an outer periphery of the body flange near a crest of the flange.
16 The outward anti-splay surface components are formed near 17 an outer periphery of the mating guide and advancement 18 structures by enlargement thereof. The complementary 19 anti-splay surface components of the closure and head slidably engage upon rotation and cooperate to interlock 21 the body with the arms so as to resist splaying 22 tendencies of the arms when the closure is strongly 23 torqued or when other forces are applied to the various 24 elements thereof.
In use, the closure and open-headed bone screw are 26 used to anchor a spinal fixation member, such as a rod, 1 by threadedly implanting the bone screw into a bone and 2 clamping the rod within the head of the bone screw using 3 the closure body. In order to enhance clamping 4 engagement of the rod, the body may be provided with structural features which cut into the surface of the rod 6 to thereby reduce the likelihood of translational or 7 rotational movement of the rod relative to the bone 8 screw. The body is preferably provided with a ~~cup 9 point", set ring, or V-ring on a forward end of the body to cut into the surface of the rod when the body is 11 tightly torqued into the head of the bone screw. In some 12 embodiments, the body is also provided with a central 13 axial point on the leading end thereof.
Objects and Advantages of the Invention 17 Therefore, objects of the present invention include 18 providing an improved closure for use with an open headed 19 bone screw; providing such a closure having a cylindrical base or body and a driving or installation head that 21 breaks away from the body at a breakaway region to 22 provide a low or minimized profile subsequent to 23 installation of the closure; providing such a closure 24 having removal structure enabling positive, non-slip engagement of the closure by a removal tool; providing 26 such a closure having an axially extending bore that 1 passes through the installation head; providing such a 2 closure having a removal aperture that is mufti-surfaced 3 and forms a removal tool receiving socket including a 4 plurality of centrally facing surfaces positioned circumferentially about an axis of rotation of the body 6 and extending generally along the axis to form the non-? round, non-slip socket to receive a removal tool having a 8 complementary shape; providing such a closure which has 9 such a removal aperture with a mufti-lobular shape including a plurality of circumferentially spaced, 11 centrally facing, rounded lobes separated by axial 12 grooves or channels which receive splines of the removal 13 tool; providing such a closure wherein the removal socket 14 becomes fully accessible to a removal tool when the installation head breaks from the body; providing such a 16 closure in combination with an open headed bone implant 17 screw for use in anchoring a bone fixation structural 18 member, such as a rod; providing such a combination in 19 which the open headed bone screw includes a pair of spaced apart arms forming a rod receiving channel;
21 providing such a combination including an external guide 22 and advancement flange on the closure body and internal 23 mating guide and advancement structures located on inner 24 surfaces of the bone screw head which slidably mate upon rotation of the body and that interlock and cooperate to 26 resist tendencies of the arms to splay or diverge when 1 the closure is torqued tightly into clamping engagement 2 with a rod positioned in the channel or when external 3 forces are applied to the implant; providing such a 4 combination including elements to enhance setting engagement of the closure body with a rod in the bone 6 screw channel; providing such a combination in which a 7 forward end of the closure body is provided with a an 8 axially aligned point and/or peripheral cup point or V-9 ring to cut into the surface of the rod when the body is torqued and tightened, to resist translational and 11 rotational movement of the rod relative to the bone 12 screw; and providing such an anti-splay closure body with 13 a mufti-surface aperture which is economical to 14 manufacture, which is secure and efficient in use, and which is particularly well adapted for its intended 16 purpose.
17 It is a further object of the invention that a 18 closure for setting engagement with a structural member 19 and comprising a substantially cylindrical body having an outer cylindrical surface relative to a central closure 21 axis; a substantially continuous guide and advancement 22 flange extending helically about said outer cylindrical 23 surface, said flange having a leading surface and a 24 trailing surface relative to a direction of forward advancement; at least one of said leading surface or said 26 trailing surface being compound in contour and including 1 an inward facing anti-splay surface component facing 2 generally toward said closure axis; said body having a 3 mufti-surface aperture formed therein that is aligned 4 with said closure axis and that is elongated along said closure axis, said aperture opening onto a trailing 6 surface of said body and including a plurality of 7 circumferentially spaced, centrally facing surfaces 8 extending substantially parallel to said closure axis 9 that are aligned to form a removal socket adapted to receive a removal tool; and a break off installation 11 head.
12 It is a still further object of the invention that a 13 closure for setting engagement with a structural member 14 and comprising a substantially cylindrical body having an outer cylindrical surface relative to a central closure 16 axis; a guide and advancement flange extending helically 17 about said outer cylindrical surface, said flange having 18 a trailing surface relative to said forward advancement 19 direction; said trailing surface being compound in contour and including an inward facing anti-splay surface 21 component facing generally toward said closure axis; said 22 body having a mufti-lobular aperture formed therein which 23 is aligned on and elongated along said closure axis, said 24 aperture including a plurality of circumferentially spiced lobes extending substantially parallel to said 26 closure axis and said lobes circumferentially alternating 1 with bore grooves extending substantially parallel to 2 said closure axis to form a removal socket adapted to 3 receive a removal tool; and a break off installation 4 head.
It is a still further object of the invention that a 6 closure for setting engagement with a structural member 7 and including a substantially cylindrical body having an 8 outer cylindrical surface relative to a central closure 9 axis and a substantially continuous guide and advancement flange extending helically about said outer cylindrical 11 surface, said flange having a leading surface and a 12 trailing surface relative to a direction of forward 13 advancement, the improvement comprising at least one of 14 said leading surface and said trailing surface being compound in contour and including an inward facing anti-16 splay surface component facing generally toward said 17 closure axis; said body having a mufti-surfaced aperture 18 formed therein which is located and elongated along said 19 closure axis, said aperture including a plurality of circumferentially spaced surfaces extending substantially 21 parallel to said closure axis so as to form a removal 22 socket adapted to receive a removal tool; and a break off 23 installation head.
24 Other objects and advantages of this invention will become apparent from the following description taken in 26 conjunction with the accompanying drawings wherein are 1 set forth, by way of illustration and example, certain 2 embodiments of this invention.
3 The drawings constitute a part of this 4 specification, include exemplary embodiments of the present invention, and illustrate various objects and 6 features thereof.
8 Brief Description of the Drawings Fig. 1 is an enlarged perspective view of an anti-11 splay closure with a mufti-surfaced removal aperture in 12 accordance with the present invention.
13 Fig. 2 is a side elevational view of the closure at 14 a further enlarged scale.
Fig. 3 is a top plan view of the closure and 16 illustrates details of the mufti-surfaced aperture of the 17 closure with the installation head in place.
18 Fig. 4 is a bottom plan view of the closure and 19 illustrates a V-ring on a forward end of the closure.
Fig. 5 is a cross sectional view of the closure, 21 taken on line 5-5 of Fig. 3, and illustrates internal 22 details of the mufti-surfaced aperture of the closure.
23 Fig. 6 is a fragmentary side elevational view at a 24 reduced scale of the closure in combination with an open headed bone implant screw in a vertebra.
1 Fig. 7 is a view similar to Fig. 6 of the closure 2 and screw and illustrates separation of the breakaway 3 installation head from a body of the closure.
4 Fig. 8 is an enlarged cross sectional view of the body of the present invention positioned in clamping 6 relationship within an open headed bone screw and 7 illustrates details of an anti-splay guide and 8 advancement structure of the body and bone screw head.
9 Fig. 9 is an enlarged top plan view of the closure within the open headed bone screw with the installation 11 head removed.
13 Detailed Description of the Invention As required, detailed embodiments of the present 16 invention are disclosed herein; however, it is to be 17 understood that the disclosed embodiments are merely 18 exemplary of the invention, which may be embodied in 19 various forms. Therefore, specific structural and functional details disclosed herein are not to be 21 interpreted as limiting, but merely as a basis for the 22 claims and as a representative basis for teaching one 23 skilled in the art to variously employ the present 24 invention in virtually any appropriately detailed structure.
1 Referring to the drawings in more detail, the 2 reference numeral 1 generally designates an anti-splay 3 closure with a mufti-surfaced aperture, such as a multi-4 lobular aperture 2. The closure 1 generally includes a body 4 and a breakaway installation head 6. The body 4 6 is used in cooperation with an open headed bone implant 7 screw 8 (Figs. 6 and 7) to form an implant anchor 8 assembly 9 to secure or anchor a spinal fixation member 9 or rod 10 with respect to a bone 12, such as a vertebra.
The bone screw 8 includes a threaded shank 14 for 11 threadably implanting into the bone 12 and an open head 12 16 formed by a pair of spaced apart arms 18 defining a U-13 shaped channel 20 therebetween to receive the rod 10.
14 Inner and facing surfaces of the arms 18 have internal mating grooves or guide and advancement structures 22 16 (Fig. 8) tapped, or otherwise formed, therein. The head 17 16 has tool grip indentations 23 (Fig. 8) that allow a 18 gripping tool (not shown) to securely hold the head 16 19 and facilitate gripping the bone screw 8 during manipulation for implantation of the bone screw 8 into 21 the bone 12.
22 The body 4 is cylindrical in external shape about an 23 axis of rotation 25 (Fig. 7) and has a forward, leading, 24 or inner end 27 and a rear, trailing, or outer end 28.
The breakaway head 6 is connected to the body 4 at the 26 rear end 28 by way of a weakened breakaway line or ring 1 30 formed by selectively reducing the wall thickness to 2 weaken the region. The breakaway ring 30 is thinned in 3 such a manner that it fails at a selected relative torque 4 between the head 6 and the body 4, as a result of torque applied to the head 6 to tighten the body 4 within the 6 bone screw 8. As illustrated, the breakaway head 6 has a 7 hexagonal outer shape to facilitate non-slip engagement 8 by an installation tool (not shown) of a conventional 9 socket type. The head 6 may also be provided with a set of tool slots 32 for alternative or more positive non-11 slip engagement of the head 6 by the installation tool 12 and has a central bore 31 with an upper chamfer 33.
13 Separation of the head 6 from the body 4, as shown in 14 Fig. 7, is desirable to control or limit torque applied by the body 4 to the rod 10 within the bone screw head I6 16 and to provide a low profile joint between the body 4 and 17 the bone screw 8.
18 The body 4 is provided with a guide and advancement 19 flange 35 which extends helically about the cylindrical closure body 4. The flange 35 is enlarged near an outer 21 periphery or radial crest thereof to form a generally 22 inwardly facing or inward anti-splay surface 37. In a 23 similar manner, the mating guide and advancement 24 structures 22 are enlarged near the radially outward peripheries thereof to form generally outwardly facing or 26 outward anti-splay surfaces 39. The anti-splay or splay 1 resisting surfaces 37 and 39 mutually engage or slide 2 closely relative to one another when the body 4 is 3 rotated and thereby advanced into the bone screw head 16 4 so as to interlock thereby also interlocking the body 4 to the arms 18 to resist or prevent outward splaying of 6 the arms 18 in reaction to torque or other forces.
7 Although particular contours of the flange 35 and 8 mating structures 22 are shown herein, other contours of 9 anti-splay guide and advancement flanges 35 and mating structures 22 are foreseen. Examples of such alternative 11 configurations of anti-splay or splay resisting guide and 12 advancement flange and mating structures are disclosed in 13 U.S. Patent application, Serial No. 10/236,123 which is 14 now U.S. Patent No.6,726,689, and which is incorporated herein by reference. The flange 35 and mating structures 16 22 cooperate to guide and advance the body 4 into 17 clamping engagement with the rod 10 within the channel 20 18 in response to clockwise rotation of the body 4.
19 In order to more positively secure the rod 10 within the head 16 of the bone screw 8, the body 4 is provided 21 with a V-ring or "cup point" 42 on the inner or forward 22 end 27 thereof. The V-ring 42 cuts into the surface of 23 the rod 10 when the body 4 is tightly torqued into the 24 head 16. The V-ring 42 extends about a periphery of the inner end 27 of the body 4 and, thus, provides two 1 possible areas of engagement between the body 4 and the 2 rod 10.
3 In the great majority of cases, the body 4 is 4 torqued into engagement with the rod 10 in the bone screw 8, the installation head 6 is broken away, and the anchor 6 assembly 9 is permanently implanted in the bone 12.
7 However, spinal alignment geometry is complex and it is 8 sometimes necessary 9 to make adjustments to a spinal fixation system.
Additionally, slippage or failure of spinal fixation 11 components can occur due to injury to the patient, 12 deterioration of bone tissue, or the like. It is also 13 possible that an implant system using anchored rods might 14 be used therapeutically, for example, to set a broken bone, and 16 subsequently removed. For these reasons, implant anchor 17 assemblies often provide structures or mechanisms for 18 releasing an anchor assembly 9 to make such adjustments 19 or changes in a spinal fixation system. The anchor assembly 9 of the present invention provides formations 21 for engaging the body 4 to retract it out of the bone 22 screw head 16 to release the rod 10 to enable adjustment 23 of the position of the rod 10 relative to the bone screw 24 8.
The mufti-surfaced aperture 2 is coaxially 26 positioned relative to the body 4 axis of rotation 25 and 1 provided for non-slip engagement by a closure removal 2 tool (not shown) having a shape which is complementary to 3 the shape of the aperture 2. The illustrated aperture 2 4 is multi-lobular and is formed by a plurality of circumferentially spaced, axially extending lobes 45 6 separated by intervening spline receiving grooves 47.
7 The closure removal tool (not shown) for engagement with 8 the aperture 2 has a shape which is complementary thereto 9 and includes circumferentially spaced splines corresponding to the grooves 47 and removal tool grooves 11 corresponding to the lobes 45. The aperture 2 may be of 12 a Torx type shape which is ~~hexlobular" or six lobed, or 13 other mufti- lobular shape.
14 It is also foreseen that the mufti-surfaced aperture 2 could be a simpler shape, such as a mufti-faceted shape 16 having a square, triangular, rectangular, etc. shape.
17 Such a mufti-faceted shape could include a hexagonal 18 Allen type socket (not shown) and an appropriately shaped 19 closure removal tool (not shown). Alternatively, other non-circular, mufti-surfacedshapes are envisioned for 21 the shape of the aperture however, the axis 25 passes 2;
22 through the perture 2 so to facilitate rotation of a as 23 the body 4 a tool having a single mating projection by 24 that conforms to the aperture 2.
It is to be understood that while certain forms of 26 the present invention have been illustrated and described 1 herein, it is not to be limited to the specific forms or 2 arrangement of parts described and shown.
Claims (20)
1. A closure for setting engagement with a structural member and comprising:
(a) a substantially cylindrical body having an outer cylindrical surface relative to a central closure axis;
(b) a substantially continuous guide and advancement flange extending helically about said outer cylindrical surface, said flange having a leading surface and a trailing surface relative to a direction of forward advancement;
(c) at least one of said leading surface or said trailing surface being compound in contour and including an inward facing anti-splay surface component facing generally toward said closure axis;
(d) said body having a multi-surface aperture formed therein that is aligned with said closure axis and that is elongated along said closure axis, said aperture opening onto a trailing surface of said body and including a plurality of circumferentially spaced, centrally facing surfaces extending substantially parallel to said closure axis that are aligned to form a removal socket adapted to receive a removal tool; and (e) a break off installation head.
(a) a substantially cylindrical body having an outer cylindrical surface relative to a central closure axis;
(b) a substantially continuous guide and advancement flange extending helically about said outer cylindrical surface, said flange having a leading surface and a trailing surface relative to a direction of forward advancement;
(c) at least one of said leading surface or said trailing surface being compound in contour and including an inward facing anti-splay surface component facing generally toward said closure axis;
(d) said body having a multi-surface aperture formed therein that is aligned with said closure axis and that is elongated along said closure axis, said aperture opening onto a trailing surface of said body and including a plurality of circumferentially spaced, centrally facing surfaces extending substantially parallel to said closure axis that are aligned to form a removal socket adapted to receive a removal tool; and (e) a break off installation head.
2. The closure as set forth in Claim 1 wherein said multi-surfaced aperture includes:
(a) a multi-lobular aperture elongated along said closure axis, said aperture including a plurality of circumferentially spaced lobes extending substantially parallel to said closure axis and facing generally toward said closure axis.
(a) a multi-lobular aperture elongated along said closure axis, said aperture including a plurality of circumferentially spaced lobes extending substantially parallel to said closure axis and facing generally toward said closure axis.
3. The closure as set forth in Claim 2 wherein:
(a) said lobes circumferentially alternate with grooves extending substantially parallel to said closure axis.
(a) said lobes circumferentially alternate with grooves extending substantially parallel to said closure axis.
4. The closure as set forth in Claim 1 and including:
(a) said installation head is shaped to enable non-slip engagement of said installation head by an installation tool; and (b) said installation head being connected to said closure by a breakaway region formed in such a manner that said breakaway region fails in response to a selected level of torque between said installation head and said closure to enable separation of said installation head from said body and to expose said removal socket.
(a) said installation head is shaped to enable non-slip engagement of said installation head by an installation tool; and (b) said installation head being connected to said closure by a breakaway region formed in such a manner that said breakaway region fails in response to a selected level of torque between said installation head and said closure to enable separation of said installation head from said body and to expose said removal socket.
5. The closure as set forth in Claim 1 and including:
(a) said body having a forward end relative to said forward advancement direction; and (b) said body having a V-shaped set ring formed on said forward end to enhance setting engagement of said body into a surface of a structural member.
(a) said body having a forward end relative to said forward advancement direction; and (b) said body having a V-shaped set ring formed on said forward end to enhance setting engagement of said body into a surface of a structural member.
6. The closure as set forth in Claim 1 in combination with a bone implant screw adapted for connection to a bone fixation structural member, said bone implant screw including:
(a) a threaded shank adapted for threaded implanting into a bone;
(b) an open head formed by a pair of spaced apart arms having mutually facing channel surfaces defining a structural member receiving channel to receive a bone fixation structural member;
and (c) said mutually facing channel surfaces having respective mating guide and advancement structures formed therein which are compatible with and rotatably mateable with said guide and advancement flange to enable guiding and advancement of said body into said channel to thereby clamp said bone fixation structural member therein and to interlock said body and arms.
(a) a threaded shank adapted for threaded implanting into a bone;
(b) an open head formed by a pair of spaced apart arms having mutually facing channel surfaces defining a structural member receiving channel to receive a bone fixation structural member;
and (c) said mutually facing channel surfaces having respective mating guide and advancement structures formed therein which are compatible with and rotatably mateable with said guide and advancement flange to enable guiding and advancement of said body into said channel to thereby clamp said bone fixation structural member therein and to interlock said body and arms.
7. The closure and bone implant screw combination as set forth in Claim 6 wherein:
(a) said mating guide and advancement structures of said bone implant screw include an outward anti-splay surface component which cooperates with said inward anti-splay surface component of said closure in such a manner as to resist a tendency of said arms to splay in reaction to torquing said closure into engagement with said bone fixation structural member.
(a) said mating guide and advancement structures of said bone implant screw include an outward anti-splay surface component which cooperates with said inward anti-splay surface component of said closure in such a manner as to resist a tendency of said arms to splay in reaction to torquing said closure into engagement with said bone fixation structural member.
8. The combination as set forth in Claim 7 wherein:
(a) said guide and advancement flange has a relatively enlarged region near an outer periphery thereof that forms said inward anti-splay surface component;
(b) said mating guide and advancement structures are contoured in a complementary manner to said guide and advancement flange to form said outward anti-splay surface component; and (c) said inward anti-splay surface component engages said outward anti-splay surface component when said closure is guided and advanced into said open screw head of said bone implant screw so as to interlock said body to said arms to resist radially outward splaying movement of said arms.
(a) said guide and advancement flange has a relatively enlarged region near an outer periphery thereof that forms said inward anti-splay surface component;
(b) said mating guide and advancement structures are contoured in a complementary manner to said guide and advancement flange to form said outward anti-splay surface component; and (c) said inward anti-splay surface component engages said outward anti-splay surface component when said closure is guided and advanced into said open screw head of said bone implant screw so as to interlock said body to said arms to resist radially outward splaying movement of said arms.
9. A closure for setting engagement with a structural member and comprising:
(a) a substantially cylindrical body having an outer cylindrical surface relative to a central closure axis;
(b) a guide and advancement flange extending helically about said outer cylindrical surface, said flange having a trailing surface relative to said forward advancement direction;
(c) said trailing surface being compound in contour and including an inward facing anti-splay surface component facing generally toward said closure axis;
(d) said body having a multi-lobular aperture formed therein which is aligned on and elongated along said closure axis, said aperture including a plurality of circumferentially spaced lobes extending substantially parallel to said closure axis and said lobes circumferentially alternating with bore grooves extending substantially parallel to said closure axis to form a removal socket adapted to receive a removal tool; and (e) a break off installation head.
(a) a substantially cylindrical body having an outer cylindrical surface relative to a central closure axis;
(b) a guide and advancement flange extending helically about said outer cylindrical surface, said flange having a trailing surface relative to said forward advancement direction;
(c) said trailing surface being compound in contour and including an inward facing anti-splay surface component facing generally toward said closure axis;
(d) said body having a multi-lobular aperture formed therein which is aligned on and elongated along said closure axis, said aperture including a plurality of circumferentially spaced lobes extending substantially parallel to said closure axis and said lobes circumferentially alternating with bore grooves extending substantially parallel to said closure axis to form a removal socket adapted to receive a removal tool; and (e) a break off installation head.
10. The closure as set forth in Claim 9 and including:
(a) said installation head being shaped to enable non-slip engagement of said installation head by an installation tool; and (b) said installation head being connected to said closure by a breakaway region formed in such a manner that said breakaway region fails in response to a selected level of torque between said installation head and said closure to enable separation of said installation head from said closure and to expose said aperture socket.
(a) said installation head being shaped to enable non-slip engagement of said installation head by an installation tool; and (b) said installation head being connected to said closure by a breakaway region formed in such a manner that said breakaway region fails in response to a selected level of torque between said installation head and said closure to enable separation of said installation head from said closure and to expose said aperture socket.
11. The closure as set forth in Claim 9 and including:
(a) said body having a forward end relative to a direction of forward advancement; and (b) said body having a V-shaped set ring formed on said forward end to enhance setting engagement of said body into a surface of a structural member.
(a) said body having a forward end relative to a direction of forward advancement; and (b) said body having a V-shaped set ring formed on said forward end to enhance setting engagement of said body into a surface of a structural member.
12. The closure as set forth in Claim 9 in combination with a bone implant screw adapted for connection to a bone fixation structural member, said bone implant screw including:
(a) a threaded shank adapted for threaded implanting into a bone;
(b) an open head formed by a pair of spaced apart arms having mutually facing channel surfaces defining a structural member receiving channel to receive a bone fixation structural member;
and (c) said mutually facing channel surfaces having an internal mating guide and advancement structures formed therein which are compatible for slidably mating with said flange upon rotation of said body to enable advancement of said body into said channel to thereby clamp said bone fixation structural member therein and to interlock said body to said arms to resist splaying of said arms.
(a) a threaded shank adapted for threaded implanting into a bone;
(b) an open head formed by a pair of spaced apart arms having mutually facing channel surfaces defining a structural member receiving channel to receive a bone fixation structural member;
and (c) said mutually facing channel surfaces having an internal mating guide and advancement structures formed therein which are compatible for slidably mating with said flange upon rotation of said body to enable advancement of said body into said channel to thereby clamp said bone fixation structural member therein and to interlock said body to said arms to resist splaying of said arms.
13. The closure and bone implant screw combination as set forth in Claim 12 wherein:
(a) said mating guide and advancement structures of said bone implant screw include an outward anti-splay surface component which cooperates with said inward anti-splay surface component of said flange in such a manner as to resist splaying of said arms.
(a) said mating guide and advancement structures of said bone implant screw include an outward anti-splay surface component which cooperates with said inward anti-splay surface component of said flange in such a manner as to resist splaying of said arms.
14. The combination as set forth in Claim 13 wherein:
(a) said flange has a relatively enlarged region near an outer periphery thereof that forms said inward anti-splay surface component;
(b) said mating guide and advancement structures are contoured in a complementary manner to said flange to form said outward anti-splay surface component; and (c) said inward anti-splay surface component engages said outward anti-splay surface component when said closure is rotated into said open screw head of said bone implant screw.
(a) said flange has a relatively enlarged region near an outer periphery thereof that forms said inward anti-splay surface component;
(b) said mating guide and advancement structures are contoured in a complementary manner to said flange to form said outward anti-splay surface component; and (c) said inward anti-splay surface component engages said outward anti-splay surface component when said closure is rotated into said open screw head of said bone implant screw.
15. A closure for setting engagement with a structural member and including a substantially cylindrical body having an outer cylindrical surface relative to a central closure axis and a substantially continuous guide and advancement flange extending helically about said outer cylindrical surface, said flange having a leading surface and a trailing surface relative to a direction of forward advancement, the improvement comprising:
(a) at least one of said leading surface and said trailing surface being compound in contour and including an inward facing anti-splay surface component facing generally toward said closure axis;
(b) said body having a multi-surfaced aperture formed therein which is located and elongated along said closure axis, said aperture including a plurality of circumferentially spaced surfaces extending substantially parallel to said closure axis so as to form a removal socket adapted to receive a removal tool; and (c) a break off installation head.
(a) at least one of said leading surface and said trailing surface being compound in contour and including an inward facing anti-splay surface component facing generally toward said closure axis;
(b) said body having a multi-surfaced aperture formed therein which is located and elongated along said closure axis, said aperture including a plurality of circumferentially spaced surfaces extending substantially parallel to said closure axis so as to form a removal socket adapted to receive a removal tool; and (c) a break off installation head.
16. The closure as set forth in Claim 15 wherein said multi-surfaced aperture is:
(a) a multi-lobular aperture elongated along said closure axis, said aperture including a plurality of circumferentially spaced lobes extending substantially parallel to said closure axis and said lobes circumferentially alternating with grooves extending substantially parallel to said closure axis.
(a) a multi-lobular aperture elongated along said closure axis, said aperture including a plurality of circumferentially spaced lobes extending substantially parallel to said closure axis and said lobes circumferentially alternating with grooves extending substantially parallel to said closure axis.
17. The closure as set forth in Claim 15 and including:
(a) said installation head being shaped to enable non-slip engagement of said installation head by an installation tool; and (b) said installation head being connected to said body by a breakaway region formed in such a manner that said breakaway region fails in response to a selected level of torque between said installation head and said body to enable separation of said installation head from said body.
(a) said installation head being shaped to enable non-slip engagement of said installation head by an installation tool; and (b) said installation head being connected to said body by a breakaway region formed in such a manner that said breakaway region fails in response to a selected level of torque between said installation head and said body to enable separation of said installation head from said body.
18. The closure as set forth in Claim 15 and including:
(a) said body having a forward end relative to said direction of forward advancement; and (b) said body having a V-shaped set ring formed on said forward end to enhance setting engagement of said body into a surface of such a structural member.
(a) said body having a forward end relative to said direction of forward advancement; and (b) said body having a V-shaped set ring formed on said forward end to enhance setting engagement of said body into a surface of such a structural member.
19. The closure as set forth in Claim 15 in combination with a bone implant screw adapted for connection to a bone fixation structural member, said bone implant screw including:
(a) a threaded shank adapted for threaded implanting into a bone;
(b) an open head formed by a pair of spaced apart arms having mutually facing channel surfaces defining a structural member receiving channel to receive a bone fixation structural member;
(c) said mutually facing channel surfaces having respective mating guide and advancement structures formed therein which are compatible to allow rotational mating with said guide and advancement flange to enable guiding and advancement of said body into said channel to thereby clamp said bone fixation structural member therein and to interlock said arms to said body to resist splaying of said arms; and (d) said mating guide and advancement structures of said bone implant screw including an outward anti-splay surface component which cooperates with said inward anti-splay surface component of said flange in such a manner as to resist a tendency of said arms to splay in reaction to torquing and other forces.
(a) a threaded shank adapted for threaded implanting into a bone;
(b) an open head formed by a pair of spaced apart arms having mutually facing channel surfaces defining a structural member receiving channel to receive a bone fixation structural member;
(c) said mutually facing channel surfaces having respective mating guide and advancement structures formed therein which are compatible to allow rotational mating with said guide and advancement flange to enable guiding and advancement of said body into said channel to thereby clamp said bone fixation structural member therein and to interlock said arms to said body to resist splaying of said arms; and (d) said mating guide and advancement structures of said bone implant screw including an outward anti-splay surface component which cooperates with said inward anti-splay surface component of said flange in such a manner as to resist a tendency of said arms to splay in reaction to torquing and other forces.
20. The combination as set forth in Claim 19 wherein:
(a) said guide and advancement flange has a relatively enlarged region near an outer periphery thereof that forms said inward anti-splay surface component;
(b) said mating guide and advancement structures are contoured in a complementary manner to said guide and advancement flange to form said outward anti-splay surface component; and (c) said inward anti-splay surface component engages said outward anti-splay surface component when said closure is guided and advanced into said open screw head of said bone implant screw so as to radially interlock.
(a) said guide and advancement flange has a relatively enlarged region near an outer periphery thereof that forms said inward anti-splay surface component;
(b) said mating guide and advancement structures are contoured in a complementary manner to said guide and advancement flange to form said outward anti-splay surface component; and (c) said inward anti-splay surface component engages said outward anti-splay surface component when said closure is guided and advanced into said open screw head of said bone implant screw so as to radially interlock.
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US10/783,889 | 2004-02-20 | ||
US10/783,889 US8282673B2 (en) | 2002-09-06 | 2004-02-20 | Anti-splay medical implant closure with multi-surface removal aperture |
PCT/US2004/031862 WO2005081689A2 (en) | 2004-02-20 | 2004-09-29 | Anti-splay medical implant closure with removal aperture |
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CA2555874A1 CA2555874A1 (en) | 2005-09-09 |
CA2555874C true CA2555874C (en) | 2010-07-27 |
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CA2555874A Expired - Fee Related CA2555874C (en) | 2004-02-20 | 2004-09-29 | Anti-splay medical implant closure with multi-surface removal aperture |
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US (4) | US8282673B2 (en) |
EP (1) | EP1715797A4 (en) |
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- 2004-09-29 EP EP04789192A patent/EP1715797A4/en not_active Withdrawn
- 2004-09-29 JP JP2006554081A patent/JP4510032B2/en not_active Expired - Fee Related
- 2004-09-29 AU AU2004316268A patent/AU2004316268C1/en not_active Ceased
- 2004-09-29 CA CA2555874A patent/CA2555874C/en not_active Expired - Fee Related
- 2004-09-29 WO PCT/US2004/031862 patent/WO2005081689A2/en active Application Filing
-
2007
- 2007-10-05 US US11/973,155 patent/US8128667B2/en active Active
-
2012
- 2012-08-02 US US13/507,854 patent/US8591552B2/en not_active Expired - Lifetime
-
2013
- 2013-11-21 US US14/086,204 patent/US20140081335A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
US8128667B2 (en) | 2012-03-06 |
US20120310286A1 (en) | 2012-12-06 |
WO2005081689A3 (en) | 2005-12-01 |
WO2005081689A2 (en) | 2005-09-09 |
US8591552B2 (en) | 2013-11-26 |
AU2004316268A1 (en) | 2005-09-09 |
JP4510032B2 (en) | 2010-07-21 |
US8282673B2 (en) | 2012-10-09 |
US20080039848A1 (en) | 2008-02-14 |
AU2004316268B2 (en) | 2008-05-22 |
EP1715797A4 (en) | 2010-09-29 |
US20140081335A1 (en) | 2014-03-20 |
CA2555874A1 (en) | 2005-09-09 |
JP2007522870A (en) | 2007-08-16 |
US20040172032A1 (en) | 2004-09-02 |
AU2004316268C1 (en) | 2008-12-04 |
EP1715797A2 (en) | 2006-11-02 |
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EEER | Examination request | ||
MKLA | Lapsed |
Effective date: 20150929 |