EP1605873A4 - Outil pour dispositif de fixation osseuse - Google Patents

Outil pour dispositif de fixation osseuse

Info

Publication number
EP1605873A4
EP1605873A4 EP04716129A EP04716129A EP1605873A4 EP 1605873 A4 EP1605873 A4 EP 1605873A4 EP 04716129 A EP04716129 A EP 04716129A EP 04716129 A EP04716129 A EP 04716129A EP 1605873 A4 EP1605873 A4 EP 1605873A4
Authority
EP
European Patent Office
Prior art keywords
bone
tool
pin
proximal
piece
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04716129A
Other languages
German (de)
English (en)
Other versions
EP1605873A2 (fr
Inventor
Brad S Culbert
Marty Padget
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Interventional Spine Inc
Original Assignee
Triage Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Triage Medical Inc filed Critical Triage Medical Inc
Publication of EP1605873A2 publication Critical patent/EP1605873A2/fr
Publication of EP1605873A4 publication Critical patent/EP1605873A4/fr
Withdrawn legal-status Critical Current

Links

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
    • A61B17/683—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
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8872—Instruments for putting said fixation devices against or away from the bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
    • A61B17/7266—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with fingers moving radially outwardly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7291—Intramedullary pins, nails or other devices for small bones, e.g. in the foot, ankle, hand or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8685—Pins or screws or threaded wires; nuts therefor comprising multiple separate parts
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8897—Guide wires or guide pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive

Definitions

  • the invention relates in general to the field of bone fixation devices, and more specifically, to an insertion tool for a bone fixation device. Description of the Related Art
  • K-wires Kirschner wires
  • intrameduUary pins wiring, plates, screws, and combinations of the foregoing.
  • the particular device or combination of devices is selected to achieve the best anatomic and functional condition of the traumatized bone with the simplest operative procedure and with a minimal use of foreign-implanted stabilizing material.
  • alternate bone fixation devices are also known in the art, such as, for example, those disclosed in U.S. Patent No. 4,688,561 to Reese, U.S. Patent No. 4,790,304 to Rosenberg, and U.S. Patent No. 5,370,646 to Reese, et al.
  • K-wire fixation is attended by certain known risks. For example, a second surgical procedure is required to remove the device after healing is complete. Removal is recommended, because otherwise the bone adjacent to an implant becomes vulnerable to stress shielding as a result of the differences in the modulus of elasticity and density between metal and the bone.
  • an implanted K-wire may provide a site for a variety of complications ranging from pin-tract infections to abscesses, resistant osteomyelitis, septic arthritis, and infected nonunion.
  • K-wires Another potential complication involving the use of K-wires is in vivo migration. Axial migration of K-wires has been reported to range from 0 mm to 20 mm, which can both increase the difficulty of pin removal as well as inflict trauma to adjacent tissue.
  • K-wires project through the skin.
  • percutaneously extending K-wires can be disrupted or cause damage to adjacent structures such as tendons if the K- wire comes into contact with external objects.
  • a method of fixing a first piece of bone to a second piece of bone comprises providing a pin having at least one laterally moveable distal anchor and a lumen extending therethrough.
  • the distal anchor is inserted through the first piece of bone and into the second piece of bone while the distal anchor is permitted to move laterally inwardly as needed.
  • a deployment tool grips a proximal portion of a wire that extends axially through the lumen.
  • the deployment tool moves the wire axially through the lumen such that a distal portion of the wire resists radial inward deflection of the distal anchor, thereby locking the distal anchor with respect to lateral inward movement.
  • a tool for inserting a bone fixation device includes an outer body and an inner body, each having a proximal end, a distal end, and a longitudinal axis.
  • the tool also includes a pin-receiving portion at the distal end of the outer body for receiving a proximal pin of a bone fixation device.
  • the tool further includes first and second levers pivotally mounted to the inner member at respective pivot axes, and each of the levers having a gripping portion.
  • a tool which comprises body having a proximal end and a distal end.
  • the tool further includes at least one finger grip portion, a pin-gripping portion at the distal end of the body.
  • the tool is configured such that proximal movement of the at least one finger grip portion causes a guidewire of a bone fixation device to be gripped and moved proximally with respect to a pin of the bone fixation device.
  • the tool comprises a longitudinal tubular outer body having a proximal end, a distal end, and at least one longitudinal slot in the outer body.
  • the tool also includes a longitudinal inner body slidably and concentrically disposed within the outer body, and at least one lever pivotally mounted to a distal portion of the inner body.
  • the lever preferably includes a finger engagement portion, a wire-gripping portion, and is preferably configured to be axially movable within the slot.
  • the lever is preferably configured such that a proximal force on the finger engagement portion relative to the outer body will cause the pin engagement portion to close and to move proximally.
  • a bone fixation system which includes a bone fixation device and an insertion tool.
  • the bone fixation device comprises: a first elongate tubular body, having a proximal end, a distal end and a longitudinal axis.
  • a distal anchor is on the fixation device, movable from a low profile orientation for distal insertion through a bore in the bone to an inclined orientation to resist axial proximal movement through the bore.
  • An elongate pin is axially movable within the tubular body and associated with the anchor, such that proximal retraction of the pin with respect to the tubular body advances the distal anchor from the axial orientation to the inclined orientation.
  • the device also includes a second elongate tubular body, having a proximal end, a distal end, and a longitudinal axis. At least one retention structure lies in between the second elongate tubular body and the elongate pin. The retention structure permits proximal movement of the elongate pin with respect to the second elongate tubular body but resists distal movement of the pin with respect to the second elongate tubular body.
  • the first tubular body may be used to deploy the distal anchor, and may then be removed and replaced by the second tubular body.
  • the second tubular body cooperates with the pin to apply compression to the bone.
  • the system also includes an insertion device comprising an elongate body having a proximal end, a distal end, and a central axis.
  • the insertion device also includes a pair of levers configured to be pivotally and axially movable relative to the body.
  • the levers preferably have finger engagement portions and pin engagement portions.
  • the insertion device is preferably configured such that a force applied to the finger engagement portions causes the levers to be engaged on the pin of the fixation device, and causes the pin to be proximally retracted.
  • Figure 1 is a schematic section view of a bone fixation device positioned within a fractured bone
  • Figure 2 is a side elevational view of an alternate embodiment of a pin body in accordance with the present invention.
  • Figure 3 is a distal end elevational view of the pin body of Figure 2;
  • Figure 4 is a longitudinal cross-sectional view through the pin body of Figure 2;
  • Figure 5 is an enlarged detail view of the distal end of the device shown in Figure 4.
  • Figure 6 is a cross-sectional view through a proximal anchor for use with the pin body of Figure 2;
  • Figure 7 is a proximal end elevational view of the proximal anchor of Figure 6;
  • Figure 8 is a side elevational view of a guide wire that may be used with the pin body of Figure 2;
  • Figure 9 is a longitudinal cross-sectional view of the guide wire of Figure 8 and the pin body of Figure 2;
  • Figure 10 is a perspective view of a bone fixation device insertion tool having desired features and advantages;
  • Figure 11 is a section view of the insertion tool of Figure 10 taken along line 11-11;
  • Figure 11 A is a side perspective view of a central portion of the insertion tool of Figure 10;
  • Figure 12 is a section view of the insertion tool of Figure 10 taken along line 12-12;
  • Figure 13 is an elevation view of the insertion tool of Figure 10 including a bone fixation device disposed thereon;
  • Figure 14 is a section view of the insertion tool of Figure 10 taken along line 14-14, shown with a bone fixation device in a first position;
  • Figure 15 is a section view of the insertion tool of Figure 10 taken along line 15-15, shown with a bone fixation device in a second position;
  • Figure 16 is a detailed section view of a portion of the insertion tool of Figure 14 taken along line 16-16;
  • Figure 17 is detailed section view of a portion of the insertion tool of Figure 15 taken through line 17-17;
  • Figure 18 is a sectional schematic illustration of a bone fixation device and an insertion tool, the bone fixation device being inserted across a fractured bone;
  • Figure 19 is a sectional schematic illustration of a bone fixation device and an insertion tool, the bone fixation device being anchored across a fractured bone;
  • Figure 20 is a sectional schematic illustration of a bone fixation device being used to secure first and second fragments of a fractured bone.
  • the bone fixation device can be applicable in a wide variety of fractures and osteotomies in the hand, such as interphalangeal and metacarpophalangeal arthrodesis, transverse phalangeal and metacarpal fracture fixation, spiral phalangeal and metacarpal fracture fixation, oblique phalangeal and metacarpal fracture fixation, intercondylar phalangeal and metacarpal fracture fixation, phalangeal and metacarpal osteotomy fixation as well as others l ⁇ iown in the art.
  • a wide variety of phalangeal and metatarsal osteotomies and fractures of the foot may also be stabilized using the bone fixation device of the present invention.
  • distal metaphyseal osteotomies such as those described by Austin and Reverdin- Laird, base wedge osteotomies, oblique diaphyseal, digital arthrodesis as well as a wide variety of others that will be l ⁇ iown to those of skill in the art.
  • Fractures and osteotomies and arthrodesis of the tarsal bones such as the calcaneus and talus may also be treated.
  • Spiked washers can be used, attached to the collar or freely movable beneath the collar.
  • the bone fixation device may be used with or without plate(s) or washer(s), all of which can be either permanent, absorbable or comprising both.
  • Fractures of the fibular and tibial malleoli, pilon fractures and other fractures of the bones of the leg can be fixated and stabilized with or without the use of plates, both absorbable or non-absorbing types, and with alternate disclosed embodiments.
  • One example is the fixation of the medial malleolar avulsion fragment fixation with the radially and axially expanding compression device.
  • Each of the foregoing may be treated in accordance with the present invention, by advancing one of the fixation devices disclosed herein through a first bone component, across the fracture, and into the second bone component to fix the fracture.
  • FIG. 1 there is illustrated generally a bone 10, shown in cross-section to reveal an outer cortical bone component 12 and an inner cancellous bone component 14.
  • a fracture 16 is schematically illustrated as running through the bone to at least partially divide the bone 10 into what will for the present purposes be considered a proximal component 19 and a distal component 21.
  • the fracture is simplified for the purpose of illustrating the application of the disclosed embodiments. However, as will be understood by those skilled in the art, the fracture 16 may extend through the bone at any of a wide variety of angles, depths, and sizes.
  • the fixation device includes a body 32 which is in the form of a pin 26 extending between a proximal end 28 and a distal end 30.
  • the distal end 30 includes a plurality of friction enhancing or interference fit structures such as ramped extensions or barbs 50, for engaging the distal cortical bone or other surface or interior cancellous bone.
  • the illustrated embodiment includes four barbs 50, oriented at 90° with respect to each other, anywhere from one to about twelve or more barbs 50 may be utilized as will be apparent to those of skill in the art in view of the disclosure herein.
  • the barbs 50 may be radially symmetrically distributed about the longitudinal axis of the pin 26.
  • Each barb 50 is provided with a transverse engagement surface 21, for contacting the distal surface of the cortical bone or other structure or surface against which the barb 50 is to anchor.
  • Transverse engagement surfaces 21 may lie on a plane which is transverse to the longitudinal axis of the pin 26, or may be inclined with respect to the longitudinal axis of the pin 26.
  • Each of the transverse engagement surfaces 21 in the illustrated embodiment lies on a common plane which is transverse to the longitudinal axis of the pin 26. Two or more planes containing engagement surfaces 21 may alternatively be provided.
  • the transverse engagement surfaces 21 may also lie on one or more planes which are non- normal to the longitudinal axis of pin 26.
  • the plane of a plurality of transverse engagement surfaces 21 may be inclined at an angle within the range of from about 35° or 45° to about 90° with respect to the longitudinal axis of the pin 26.
  • the plane of the transverse engagement surface may thus be selected to take into account the angle of the distal surface of the bone through which the pin may be positioned, as may be desired in certain clinical applications.
  • each barb 50 in the illustrated embodiment is carried by a flexible or hinged lever arm 23.
  • Lever arms 23 may be formed by creating a plurality of axial slots 15 in the sidewall of the pin 26.
  • the axial slots 15 cooperate with a central lumen 11 to isolate each barb 50 on a corresponding lever arm 23.
  • the axial length of the axial slots 15 may be varied depending upon various desired physical characteristics, such as the desired length over which flexing is distributed, the range of lateral motion, and upon the desired construction material.
  • axial lengths of the axial slot 15 in excess of about 0.1 inches and preferably in excess of about 0.2 inches are utilized on a pin 26 having an outside diameter of about 0.1 inches and a length of about 1.25 inches.
  • Axial slots 15 will generally extend within a range of from about 5% to about 90%, and often within about 10% to about 30% of the overall length of the pin 26.
  • the circumferential width of the slots 15 at the distal end 30 is selected to cooperate with the dimensions of the barbs 50 to permit radial inward deflection of each of the barbs 50 so that the pin 26 may be press fit through a predrilled hole having an inside diameter approximately equal to the outside diameter of the pin 26 just proximal to the transverse engagement surfaces 21.
  • at least a portion of each of the slots 15 tapers in circumferential direction width from a relatively larger dimension at the distal end 30 to a relatively smaller dimension at the proximal limit of the axial slot 15, as shown in Figure 2.
  • each slot 15 has a width of about 0.20 inches at the proximal end and a width of about 0.035 inches at the distal end in the unstressed orientation.
  • the width of the slot 15 may taper continuously along its length, or, as in the illustrated embodiment, is substantially constant for a proximal section and tapered over a distal section of the slot 15.
  • the wall thickness of the lever a ⁇ n 23 may also be tapered to increase the diameter of the central lumen 11 in the distal direction. This will allow a reduced compressed crossing profile before the inside surfaces of the lever arms bottom out against each other.
  • the pin 26 is additionally provided with a plurality of retention structures 44 for engaging with a proximal anchor 36. Relative rotational movement between the pin 26 and the proximal anchor 36 can result in relative axial movement between the pin 26 and the proximal anchor 36 [0052]
  • the retention structures 44 are configured to engage with the proximal anchor 36. In one embodiment, the retention structures 44 are spaced apart axially along the pin 26 between a proximal limit 46 and a distal limit 48. The axial distance between proximal limit 46 and distal limit 48 is related to the desired axial travel of the proximal anchor 36, and thus the range of functional sizes of the pin.
  • the retention structures 44 comprise a plurality of threads, adapted to cooperate with the complimentary retention structures 42 on the proximal anchor 36, which may be a complimentary plurality of threads.
  • the proximal anchor 36 may be distally advanced along the pin 26 by rotation of the proximal anchor 36 with respect to the pin 26.
  • Proximal anchor 36 may advantageously be removed from the pin 26 by reverse rotation to permit removal of the pin 26 from the patient.
  • collar 38 is preferably provided with a gripping configuration or structure to permit a removal tool to rotate collar 38 with respect to the pin 26. Any of a variety of gripping surfaces may be provided, such as one or more slots, flats, bores, or the like.
  • the collar 38 is provided with a polygonal, and in particular, a hexagonal circumference, as seen in Figure 7.
  • the proximal end 28 of the pin 26 is similarly provided with a structure 29 for permitting rotational engagement with an installation or a removal tool. Rotational engagement may be accomplished using any of a variety of shapes or configurations, as will be apparent to those of skill in the art.
  • One convenient structure is to provide the proximal end 28 with one or more flat side walls, for rotationally engaging a complimentary structure on the corresponding tool. As illustrated in Figure 3, the proximal end 28 may be provided with the structure 29 having a square cross-section.
  • the exterior cross-section through proximal end 28 may be any of a variety of configurations to permit rotational coupling, such as triangular, hexagonal, or other polygons, or one or more axially extending flat sides or channels on an otherwise round body.
  • the foregoing structures enable the use of an installation and/or deployment tool having a concentric core within a sleeve configuration in which a first component (e.g. a sleeve) engages the proximal anchor 36 (see Figure 6 and 7) and a second component (e.g. a core) engages the proximal rotational engagement structure 29 of pin 26.
  • the first component may be rotated with respect to the second component, so that the proximal anchor 36 may be rotated onto or off of the retention structures 44 on pin 26.
  • a first tool e.g., a pair of pliers or a wrench
  • a second tool e.g., a pair of pliers or a wrench
  • the first tool may be rotated with respect to the second tool (or vice versa), so that the proximal anchor 36 may be rotated onto or off the retention structures 44 on the pin 26.
  • the retention structures 42 on the proximal anchor 36 may be toleranced to permit distal axial advancement onto the pin 26, such as by elastic deformation, but require rotation with respect to the pin 26 in order to remove the proximal anchor 36 from the pin 26.
  • any of a variety of alternative retention structures may be configured, to permit removal of the proximal anchor 36 preferably after implantation and a bone healing period of time.
  • the retention structures 44 can be threads with a plurality of axially extending flats or interruptions. These tlireads can coriespond with a plurality of axial flats on the retention structures 42 of the proximal anchor 36. This configuration enables a partial rotation (e.g., 90°) of the proximal anchor 36 with respect to the pin 26 to disengage the retention structures 42, 44 and permit axial withdrawal of the proximal anchor 36 from the pin 26.
  • the retention structures 42 and 44 may comprise a helical thread or one or more circumferentially extending ridges or grooves.
  • the retention structures 42, 44 can have a pitch to achieve the desired axial movement based on relative rotational movement between the pin 26 and the proximal anchor 36.
  • the threads of the retention structures 42, 44 can have a fine pitch to a course pitch. For example, a fine pitch may be selected where a number of rotations of proximal anchor 36 is desired to produce a relatively small axial travel of the anchor 36 with respect to the pin 26. hi this configuration, relatively high compressive force can be achieved between the proximal anchor 36 and the distal anchor 34.
  • the threads of the retention structures 42, 44 have a relatively course pitch, such as might be found on a luer connector. These threads can provide quick twist connection for rapid relative axial movement of between the pin 26 and the proximal anchor 36. A relatively low number of rotations or partial rotation of the proximal anchor 36 provides a significant axial travel with respect to the pin 26. This configuration may enhance the tactile feedback with respect to the degree of compression placed upon the bone.
  • the thread pitch or other characteristics of the corresponding retention structures can be optimized through routine experimentation by those of skill in art in view of the disclosure herein, taking into account the desired clinical performance.
  • the pin 26 can have a break point to facilitate breaking and removal of a proximal portion of the pin 26.
  • the break point can be located proximal the proximal anchor 36 when the proximal anchor 36 is fhreadably coupled to the pin 26.
  • At least a first break point 31 can be a portion of the pin 26 with a reduced wall thicl ⁇ iess. That is, the break point 31 of the pin 26 can have a cross-sectional area less than the cross-sectional area of other portions of the pin 26.
  • Break point 31 in the illustrated embodiment comprises an annular recess or groove, which provides a designed failure point if lateral force is applied to the proximal end 28 while the remainder of the attachment system is relatively securely fixed.
  • At least a second break point 33 may also be provided, depending upon the axial range of travel of the proximal anchor 36 with respect to the pin 26.
  • the distal break point 31 is provided with one or more perforations or a deeper recess than the proximal break point 33. In this manner, the distal break point 31 will preferentially fail before the proximal break point 33 in response to lateral pressure on the proximal end 28. This will ensure the minimum projection of the pin 26 beyond the collar 38 following deployment and severing of the proximal end 28 as will be appreciated in view of the disclosure herein.
  • Proximal projection of the proximal end 28 from the proximal anchor 36 following implantation and breaking at a breakpoint 31 may additionally be minimized or eliminated by allowing the breakpoint 31 or 33 to break off within the proximal anchor 36.
  • the retention structure 42 may terminate at a point 61 distal to a proximal surface 63 on the anchor 36.
  • An inclined or tapered annular surface 65 increases the inside diameter of the central aperture through proximal anchor 36, in the proximal direction.
  • proximal anchor 36 After the proximal anchor 36 has been distally advanced over a pin 26, such that a breakpoint 31 is positioned between the proximal limit 61 and the proximal surface 63, lateral pressure on the proximal end 28 of pin 26 will allow the breakpoint 31 to break within the area of the inclined surface 65. i this manner, the proximal end of the pin 26 following breaking resides at or distally of the proximal surface 63, thus minimizing the profile of the device and potential tissue irritation.
  • installation can be simplified through the use of an installation tool.
  • the installation tool may comprise a pistol grip, a syringe-type grip, or plier-type grip so that the clinician can position the tool at the proximal extension of pin 32 and through one or more contractions with the hand, the proximal anchor 36, 52 and distal anchor 34 can be drawn together to appropriately tension against the bone fragments.
  • the use of a precalibrated tool can permit the application of a predetermined tension in a uniform manner from pin to pin.
  • Calibration of the installation device to set a predetermined load on the pin can be accomplished through any of a variety of means which will be understood to those of skill in the art.
  • the pin 32 may be provided with one or more score lines or transverse bores or other modifications which limit the tensile strength of the part at one or more predetermined locations. In this manner, axial tension applied to the proximal end 28 with respect to the collar 54 will apply a predetermined load to the bone before the pin 32 will separate at the score line.
  • internal structures within the installation tool can be provided to apply tension up to a predetermined limit and then release tension from the distal end of the tool.
  • Figure 8 illustrates a locking guide wire 150 that may be used with the fixation device 25 described above.
  • the guide wire has a distal end 152 and a proximal end 154.
  • the illustrated guide wire 150 comprises a locking portion 156 that is located at the distal end 152 of the guide wire 150 and an elongated portion 158 that preferably extends from the distal portion 156 to the proximal end 154 of the guide wire 150.
  • the diameter Dl of the elongated portion 158 is generally smaller than the diameter D2 of the distal portion 154.
  • the guide wire 150 can be made from stainless steel, titanium, or any other suitable material.
  • the guide wire 150 and locking portion 156 are made from the same material as the remainder of the fixation device 25 to prevent cathodic reactions.
  • the locking portion 156 on guide wire 150 can take any of a variety of forms, and accomplish the intended function as will be apparent to those of skill in the art in view of the disclosure herein.
  • a generally cylindrical locking structure as illustrated, may be used.
  • any of a variety of other configurations in which the cross section is greater than the cross section of the proximal portion 158 may be used.
  • Conical, spherical, or other shapes may be utilized, depending upon the degree of compression desired and the manner in which the locking portion 156 is designed to interfit with the distal end 30 of the pin.
  • the guide wire 150 is configured such that its proximal end can be inserted through the lumen 11 of the pin 26.
  • the lumen 11 preferably comprises a first portion 160 and a second portion 162.
  • the first portion 160 is generally located at the distal end 30 within the region of the lever arms of the pin 26.
  • the second portion 162 preferably extends from the first portion 160 to the proximal end 28 of the pin 26.
  • the inside diameter of the first portion 160 is generally larger than the diameter of the second portion 162.
  • the junction between the first portion 160 and the second portion 162 forms a transverse annular engagement surface 164, which lies transverse to the longitudinal axis of the pin 26.
  • the guide wire 150 is configured such that its proximal end can be inserted through the lumen 11 of the pin 26.
  • the diameter Dl of the elongated portion 158 is less than the diameter of the second portion 162 of the lumen 11.
  • the diameter D2 of distal portion 156 is generally equal to or larger than the diameter of the first portion 160 and larger than the diameter of the second portion 162. This arrangement allows the distal portion 156 to be retracted proximally into the first portion 160 but prevents the distal portion 156 from passing proximally through the pin 26.
  • the first portion may expand the distal anchor 34 beyond its relaxed diameter.
  • any of a variety of friction enhancing surfaces or surface structures may be provided, to resist distal migration of the locking guide wire 150, post deployment.
  • any of a variety of radially inwardly or radially outwardly directed surface structures may be provided along the length of the locking guide wire 150, to cooperate with a corresponding surface structure on the inside surface of the lumen 11, to removably retain the locking guide wire 150 therein, hi one embodiment, a cylindrical groove or ridge is provided on the inside surface of the lumen 11 to cooperate with a radially outwardly extending annular flange or groove on the outside diameter of the locking guide wire 150.
  • the complementary surface structures may be toleranced such that the locking guidewire or guide pin may be proximally retracted into the lumen 11 to engage the locking structure, but the locking structure provides a sufficient resistance to distal migration of the locking guide wire 150 such that it is unlikely or impossible to become disengaged under normal use.
  • Embodiments of an insertion tool 200 for inserting and deploying a bone fixation device are illustrated in Figures 10-20.
  • the illustrated insertion tool 200 is particularly configured for deploying bone fixation devices that utilize a pin 26 and a locking guide wire 150 such as the bone fixation devices described above and those described in U.S. Patent No. 6,632,224 filed March 22, 2001, which is incorporated by reference herein in its entirety. Accordingly, the insertion tool will be described with reference to the locking device described above. However, it should be appreciated, certain features of the insertion tool 200 may also find utility in bone fixation devices that do not utilize a pin and/or a locking guide wire 150.
  • the insertion tool 200 of the illustrated embodiment generally comprises an elongate tubular outer body 210, a pair of levers 230, and central member 250 slidably positioned within the tubular outer body 210 and coupled to the levers 230.
  • the levers 230 are configured to engage the locking guidewire 150.
  • the tool 200 also comprises a distal portion 220 that is coupled to the outer body 210 and is configured to engage the pin 26 of the bone fixation device.
  • the insertion tool 200 is configured to grip and move the locking guidewire 150 in a proximal direction with respect to the pin 26. In this manner, the distal portion 156 of the locking guidewire 150 may be retracted proximally into the first portion 160 (see Figure 9) of the lumen 11 to resist compression of the lever arms of the pin 26.
  • the outer body 210 is a generally tubular body that has a proximal end 212 and a distal end 214.
  • the outer body 210 has a pair of diametrically spaced elongated openings or slots 216 that are configured so that a portion of the levers 230 extend from the outer body 210.
  • the slots 216 may be generally parallel and extend from an opening or window 218, which is between the distal end 214 and an upper body 253 of the outer body 210.
  • the levers 230 may slide along the slots 216 in the axial direction and at least a portion of the levers 230 maybe moved away from and/or toward the longitudinal axis of the tool 200.
  • the slots 216 and the elongated body 210 may have various shapes and configurations depending on the desired application and deployment environment, i the illustrated embodiment, the outer body 210 is formed from a tubular body having portions removed to form the window 218 and the slots 216. hi other embodiments, the outer body 210 may have other cross-sectional shapes (e.g., rectangular, elliptical, etc.)
  • the outer body 210 has an inner surface 211 that defines a chamber in which the central body 250, a biasing member 260 (e.g., a spring), a ratchet assembly 243, and a portion of the levers 230 are positioned.
  • a biasing member 260 e.g., a spring
  • the levers 230 preferably comprise finger engagement portions 232, elongated portions or arms 233, and wire gripping portions 234.
  • the levers 230 are configured so that a person can comfortably grip and apply a force on the levers 230.
  • the levers 230 of the have generally 'L' or shape.
  • the levers 230 can have any shape or configuration so that a portion of the levers 230 can engage with the bone fixture device (e.g., the locking guidewire 150) when the levers 230 are actuated.
  • the finger engagement portions 232 are at the proximal ends of the levers 230 and are generally curved, elongated members extending from the arms 233 and out of the outer body 210 (see Figure 10). The width of the finger engagement portions 232 can be reduced toward the ends 235.
  • the finger engagement portions 232 can be configured to be comfortably engaged by as many fingers of the user as desired, hi one embodiment, for example, the finger engagement portions 232 are configured so that a person can use one finger to apply a force to the upper finger engagement portion 232 on one side of the tool 200 and another finger to apply a force to the lower finger engagement portion 232 on the other side of the tool 200 with the body 210 extending between the upper and lower fingers.
  • the finger engagement portions 232 can be configured to engage more than one finger of the user.
  • a further advantage is provided where the ends 235 of the finger engagement portions 232 are curved in the distal direction to prevent a person's finger or fingers from sliding off of the levers 230.
  • the finger engagement portions 232 can inhibit outward movement (i.e., away from the longitudinal axis of the tool 200) of the user's fingers.
  • the finger engagement portions 232 can have other shapes and sizes depending on, for example, the force applied to the levers 230, the size of the user's fingers and hand, the application of the tool 200, and the like.
  • the arms 233 of the levers 230 extend from the finger engagement portions 232 to the wire gripping portion 234 near the distal end of the levers 230.
  • a substantial portion of the arms 233 may have a generally rectangular cross-sectional profile.
  • the wire gripping portions 234 are pivotable with respect to the central body 250. Accordingly, in the illustrated embodiment, the wire gripping portions 234 include holes 237 for receiving pivot pins 236.
  • the wire gripping portions 234 can be in the form of tangs or prongs. However, the wire gripping portions 234 can be any shape that can engage and hold a portion of the locking wire 150 when the levers 230 are moved to a certain position.
  • the wire gripping portions 234 are configured such that the distance between the proximal portions 234a of the wire gripping portions 234 is less than the distance between distal portions 234b of wire gripping portions 234.
  • a proximal force 239 causes the proximal portions 235 a to pinch the guidewire to inhibit movement of the guidewire.
  • the distance between the proximal portions 234a and distal portions 234b are generally equal when then levers 230 grip the guidewire.
  • the wire engagement portions 234 may also include features for enhancing the gripping force.
  • the wire engagement portions 234 have grooves that engage the guidewire of the fixation device to ensure that the guidwire is securely held by the wire engagement portions 234.
  • the wire engagement portions 234 can have other surface treatments to achieve the desire interaction between the wire engagement portions 234 and portions of the fixation device.
  • the wire engagement portions 234 can have protuberances, spikes, or textured surface to provide adequate frictional forces between the wire engagement portions 234 and the bone fixture device.
  • the holes 237 are located at the distal ends of the levers 230. h one embodiment, the centers of the holes 237 are preferably located distally from at least a portion of the wire gripping portions 234. This arrangement provides mechanical advantage so that the levers 230 securely grip the guide wire 150 when the user applies sufficient force.
  • the location of the center of the holes 237 with respect to the finger grips 235 can be varied to achieve the desire leverage.
  • the levers 230 are mounted to the central body 250 for rotating about the pivot axes defined by the pins 236 along the direction of arrow P to engage the locking wire 150.
  • the outer body 210 can be held stationary by, for example, applying a distal force 241 to the outer body while the proximal force indicated by the arrows 239 can be applied to the lever 230 so that the lever pivots about the pivot pin 236 in the direction of the arrow P, thereby causing the proximal end of the lever 230 to move towards the central axis of the tool 200.
  • the upper lever 230 can be rotated clockwise about its respective pin 236 and the lower lever 230 can be rotated counter-clockwise about its respective pin 236.
  • the wire engagement portions 234 of the levers 230 are configured such that as the levers 230 pivot, the wire engagement portions 234 move towards one another, thus allowing a wire or pin positioned therebetween to be gripped.
  • a further advantage of the illustrated embodiment is that the effective length of the lever arms 233 of the levers 230 is chosen to provide a mechanical advantage, thereby allowing a relatively small generally proximal force on the finger engagement portions 232 to tightly grip the locking wire 150 (as shown in Figure 14) placed between the wire gripping portions 234.
  • the tool may be configured to grip a bone fixation device guidewire in response to an axial, angled, rotational and/or otherwise-directed force.
  • Such embodiments may incorporate additional levers, cables, pulleys, or other structures as will be clear to those skilled in the art in view of the present disclosure
  • the levers 230 may be moved in a distal direction (i.e., opposite the direction of the arrows 239 in Figure 11) so that the wire-gripping portions 234 disengage the guidewire 150.
  • the levers 230 may be outwardly biased by a biasing member 231 (e.g., a helical spring) located towards their proximal ends, hi this arrangement, the biasing member 231 may extend through an opening or hole 277 formed in the central body 150.
  • a biasing member 231 e.g., a helical spring
  • the tool 200 comprises a stop 258 at its proximal end.
  • the stop 258 is coupled to the proximal end 212 of the outer body 210 such that a distal portion of the stop 258 is disposed within the outer body 210 while a distal portion of the stop 258 extends from the outer body 210.
  • the distal portion of the stop 258 can engage the proximal biasing member 260, which can be in the form of a helical spring.
  • the proximal biasing member 260 is preferably positioned between the stop 258 and a proximal end 249 of the central body 250 to bias the central body 250 in the distal direction.
  • the proximal end 249 has a seat or engagement surface 256 and a cylindrical body 263.
  • the proximal end of the proximal biasing member 260 engages the distal end of the stop 258 and the distal end of the proximal biasing member 260 engages the engagement surface 256 of the proximal end 249.
  • a distal portion of the spring 260 surrounds the cylindrical body 263 of the proximal end 249.
  • the cylindrical body 263 advantageously maintains the biasing member 260 in proper position during operation of the tool 200.
  • the distal portion of the biasing member 260 is between the inner surface 211 of the outer body 210 and the cylindrical body 263.
  • the central body 250 preferably comprises the biasing end 249 (discussed above), a ratchet portion 252, a wall 251, a upper body 253, and a lower body 255.
  • the biasing end 249 is at the proximal end of the central body 250 and the upper and lower bodies 253, 255 are at the other end.
  • the ratchet portion 252 is between the spring end 249 and the bodies 253, 255.
  • the wall 251 is between portions of the upper and lower bodies 253, 255.
  • the central body 250 is preferably slidably disposed within the outer body 210 and more preferably, the central body 250 is concentric with and axially movable within the outer body 210.
  • the ratchet portion 252 may allow proximal movement of the central body 250 with respect to the outer body 210 while resisting distal movement of the central body with respect to the outer body 210.
  • the ratchet portion 252 has a plurality of legs 257 (see e.g., Figures 11 and 12) that are coupled to or integrally formed with the biasing end 249 and are configured to allow a portion of the central body 250 to move past a release button 240.
  • one of the upper and lower legs 257 is on one side of the release button 240 and the other upper and lower legs 257 are on the other side of the release button 240.
  • the plurality of legs 257 form a pair of slots 259.
  • the slots 259a, 259b are sized so that the release button 240 is positioned within the slots 259a, 259b such that ratchet portion 252 can move relative to the release button 240.
  • the ratchet portion 252 may comprise any of a variety or retention structures 261 to limit movement of the central body 250 relative the outer body 210.
  • the ratchet portion 252 comprises structures 261 in the form of a plurality of ridges or teeth configured to engage a corresponding ratchet plate 254, which is axially immobile relative to the outer body 210.
  • the lower legs 257 of the ratchet portion 252 have an upper surface forming teeth 261.
  • the ratchet plate 254 has corresponding structures, such as teeth, to engage with the teeth 261 of the lower legs 257.
  • the structures 261 can be grooves, tlireads or other suitable structures for cooperating with the ratchet plate 254 to control the movement of the central body 250.
  • the ratchet plate 254 is configured such that it is biased towards the lower legs 257 of the ratchet portion 252. In this manner, the ratchet plate 254 can be configured to allow unidirectional movement of the central body 250. In the illustrated embodiment, allows the central body 250 to be axially movable in the proximal direction and restrained in a distal direction relative to the outer body 210.
  • the ratchet plate 254 may be biased using a variety of devices and methods recognized by those skilled in the art.
  • a biasing pin 262 biases the ratchet plate 254 towards the lower leg 257 and can be sized and disposed such that it will engage opposite walls of the outer body 210, and thus resist rotation about its transverse axis.
  • the biasing pin 262 is disposed in a hole in the ratchet plate 254 (see Figure 11) such that the ratchet plate 254 will also resist rotation about the transverse axis of the biasing pin 262.
  • the biasing pin 262 can ensure that the lower surface of the ratchet plate 254 engages the upper surface of the lower legs 257.
  • a spring can be used in combination with the biasing pin 262 to ensure that the ratchet plate 254 provides the desired travel of the central body 250.
  • the release button 240 (see Figures 11 and 12) is preferably provided to allow the ratchet plate 254 to release the central body 250. After the central body 250 is released, the central body 250 may be returned to its original distal position by the bias of the biasing member 260.
  • the release button 240 is a generally cylindrical member that extends from opposite walls of the outer body 210 and is coupled to the ratchet plate 254.
  • the outer body 210 has a pair of diametrically spaced holes or openings for receiving the release button 240.
  • the release button 240 is therefore axially immobile relative the outer body 210 therefore resulting in the ratchet plate 254 also being axially immobile relative the outer body 210.
  • the release button 240 is in a first position so that the ratchet plate 254 engages with the legs 257 and inhibits movement of the central body 250 in the distal direction.
  • the release button 240 is in the first position, the lower portion of the release button 240 extends from the outer body 210.
  • the release button 240 can be moved vertically to a second position (not shown) so that the upper portion of the release button 240 extends from the outer body 210. The user can move the release button 240 to the second position by applying a force in the vertical direction to the release button 240.
  • the ratchet plate 254 which is coupled to the release button 240, is spaced from the lower legs 257 such that the teeth of the ratchet plate 254 disengages the teeth 261 of the lower legs 257.
  • the central body 250 can slide in either the distal or proximal direction when the release button 240 is in the second position.
  • the biasing pin 262 and release button 240 may be coupled to the ratchet plate 254 by a press fit, welds, adhesives, tlireads, or other mechanical fastener, or any other method recognized by those skilled in the art.
  • the release button 240 and biasing pin 262 are preferably sized to be press fitted tightly within the respective holes in the ratchet plate 254.
  • the release button 240 and/or biasing pin 262 may comprise annular ridges or grooves configured to interact with corresponding structures on the ratchet plate 254 such that the release button 240 and the biasing pin 262 are substantially fixed relative to the ratchet plate 254.
  • the ratchet portion 252 may allow proximal movement of the central body 250 with respect to the outer body 210 while resisting distal movement of the central body with respect to the outer body 210.
  • the release button 240 in turn, disengages the ratchet portion 252 such that distal movement of the central body 250 is permitted. While the above described structure represents a preferred embodiment, it should be appreciated that other devices and structures may be provided for selectively allowing proximal movement of the central body 250 with respect to the outer body 210 while resisting distal movement of the central body with respect to the outer body 210.
  • the wall 251, upper body 253 and lower body 255 of the central body 250 can be coupled or integrally formed with the distal end of the ratchet portion 252.
  • the wall 251 and bodies 253, 255 cooperate to define a window 275 and slots or channels 271 that can receive at least a portion of the levers 230.
  • the wall 251 is connected the upper body 253 and the lower body 255 and defines the bottom of the channels 271.
  • the wall 251 extends from a location near the ratchet portion 252 to the proximal side of the window 275.
  • the proximal portion of the wall 251 has the opening or hole 277 for receiving at least a portion of the biasing member 231 as discussed above.
  • the opening 277 is generally circular and is sized to surround the central portion of the biasing member 231, as shown in Figure 11. Those skilled in the art recognize that opening 277 can be at various positions depending on the configuration of the levers 230.
  • the wall 251 has a generally uniform width and is disposed between a portion of the pair of levers 230.
  • the wall 251 can have other suitable shapes depending on, for example, the size of the opening 277 and the desired movement of the levers 230.
  • the wall 251 can comprise at least a partial axial opening or hole 281 for receiving the guide wire 150. The proximal end of the guide wire 150 can be inserted and advanced along the hole 281.
  • the upper body 253 is connected to the upper portion of the wall 251 and defines the upper side of the channel 271.
  • the upper body 253 has a generally semi-circular cross-section along its length.
  • the upper surface of the upper body 253 is curved to mate with the inner surface 211 of the outer body 210 (see e.g., Figure 12).
  • the upper surface of the central body 250 can slidably engage the inner surface 211 of the outer body 210 so that the central body 250 can easily slide within the outer body 210.
  • the lower body 255 is connected to the lower portion of the wall 251 and defines the lower side of the channel 271.
  • the lower body 255 also has a generally semi-circular cross-section along its length.
  • the lower surface of the upper body 255 is curved to mate with the inner surface 211 of the outer body 210.
  • the lower surface of the lower body 255 can slidably engage the inner surface 211 of the outer body 210 so that the central body 250 can easily slide within the outer body 210.
  • the lower and upper bodies 253, 255 can have other suitable shapes depending on the desired size and configuration of the channel 271 and/or the outer body 210.
  • a distal wall 273 extends from the upper body 253 to the lower body 255.
  • the distal wall 273 has a opening or hole 279 for receiving the locking wire 150 as shown in Figure 16.
  • the hole 279 can prevent substantial lateral movement of the guidewire and can ensure that the guidewire is located in the desired position.
  • the hole 279 can position the guide wire 150 equidistant between the pivot pins 236.
  • the wire engagement portions 234 can contact the guide wire 150 at approximately the same time and maintain the desired position of the guide wire 150.
  • the guide wire 150 can remain substantially straight during use of the tool 200, thus preventing bending of the guide wire 150.
  • the channels 271 receive at least a portion of the levers 230 and the biasing member 231.
  • the channels 271 in this arrangement facilitate proper movement of the levers 230 about their respective pivot pins 236.
  • the walls or sides of the channels 271 also preferably limit the vertical movement of the levers 230.
  • a window 275 is formed between the wall 251 and the distal wall 273.
  • the window 275 is configured to receive at least a portion of the wire engagement portions 234 of the levers. As shown in Figure 14, the guide wire 150 can pass through the window 275.
  • the distal portion 220 of the tool 200 is preferably configured for receiving and at least temporarily retaining a proximal pin 26 of the bone fixation device.
  • the distal portion comprises a distal cap 270 that is attached to the distal end 214 of the outer body 210.
  • the distal cap 270 comprises a housing 283, a washer 272, a washer positioning screw 274, and a pin- gripping lever arm 280.
  • the distal cap 270 also defines a wire receiving lumen 278 for receiving a portion of a bone fixation device, h the illustrated embodiment, for example, the wire receiving lumen 278 can receive the guide wire 150.
  • the housing 283 comprises a tip 302 for receiving a portion of a bone fixation device (e.g., the pin 26).
  • the tip 302 comprises an opening 304 and a body 306 that defines at least a portion of a pin receiving lumen 276.
  • the opening 304 is sized so that the proximal end 28 of the pin 26 may be passed through the opening 304 and along the pin receiving lumen 276.
  • the proximal portion of the tip 302 is preferably adapted to receive the pin-gripping arm 280. i the illustrated embodiment, the outer surface of the pin-gripping arm 280 is generally flush with the outer surface of the tip 302.
  • the housing 283 can be coupled to the distal end 214 of the outer body 210 and can extend from the distal wall 273 of the central body 250 and past the pin-gripping arm 280. hi the illustrated embodiment, the proximal portion of the housing 283 is disposed within the distal opening of the outer body 210.
  • the housing 283 defines cylindrical chamber that surrounds the washer 272, the washer positioning screw 274, and a portion of the wire 150.
  • the washer 272 advantageously inhibits fluid from passing through the tool 200.
  • the washer 272 forms a seal 308 with the guide wire 150, which is inserted through the washer, so that fluid (e.g., blood) is prevented from migrating between the wire 150 and the washer 272 and into the gripping mechanism of the insertion tool 200.
  • the washer 272 may also provide a friction or elastic fit between the washer 272 and the guide wire 150 so as to hold the guide wire 150 in place.
  • the washer 272 may also form a seal 310 between the washer 272 and the inner surface of the housing 283.
  • the seals 308, 310 prevent fluid from passing proximal the washer 272.
  • the washer 272 is typically made of a flexible material such as rubber, latex, or other pliable material.
  • the washer 272 can also be constructed from other types of materials with suitable sealing characteristics.
  • One of ordinary skill in the art can determine the appropriate combination of material type, thicl ⁇ iess, and shape to achieve the desired seals for preventing fluid flow into the mechanisms of the tool 200.
  • the washer positioning screw 274 holds and positions the washer 272 in the housing 283.
  • the washer positioning screw 274 of this arrangement has a generally cylindrical body having a proximal portion that engages the proximal portion of the inner surface of the housing 283.
  • the distal end of the washer positioning screw 274 has a circular recess for receiving the washer 272.
  • a portion of wire- receiving lumen 278 is defined by the by the washer positioning screw 274 so that the guide wire 150 can pass through the washer positioning screw 274.
  • the washer positioning screw 274 has threads on a portion of its proximal end and the housing has corresponding threads, such the washer positioning screw 274 and the housing 283 can be fhreadably coupled.
  • the desired seal 310 between the washer 272 and the housing 283 can be achieved by rotating the screw 274 relative the housing 283 to cause relative axial movement between the screw 274 and the housing 283. For example, if fluid migrates through the seal 310, the screw 274 can be rotated relative the housing 283 so that the screw moves in the distal direction thereby pushing the washer 272 against the housing 283. In this manner, the washer 272 can be compressed between the screw 274 and the housing 283 until the desired seal 310 is achieved.
  • the screw 274 is provided without tlireads and is sized to fit substantially tightly within the housing 283.
  • other types of members can be preferably tightly fit into the distal cap 270 to ensure that proper seals are formed by the washer 272.
  • the screw 274 can be made of a material such as rubber, plastic, metal, and pliable materials.
  • the screw 274 can also be constructed from other types of materials with suitable sealing characteristics.
  • One of ordinary skill in the art can determine the appropriate combination of material type, thicl ⁇ iess, and shape to achieve the desired seals for preventing fluid flow into the mechanisms of the tool 200.
  • the pin-gripping arm 280 may comprise a variety of structures configured to preferably removably hold a bone fixation device (e.g., the pin 26) within the pin-receiving lumen 276.
  • the pin- gripping arm 280 comprises a lever arm 313 with a pin-engaging ridge or tang 314.
  • the end of tang 314 can be configured and sized to hold the pin 26.
  • the pin of the bone fixation device may be provided with an annular ridge or groove 316 sized and positioned to receive the end of the tang 314 of the pin-gripping arm 280 such that the bone fixation pin is preferably held substantially rigidly by the insertion tool 200.
  • the pin- gripping arm 280 inhibits substantial axial movement of the pin 26 relative to the tool 200.
  • the tang 314 can be outwardly moved to disengage the pin-gripping arm 280 so that the pin 26 can be removed from the tool 200.
  • the tang 314 of the pin-gripping arm 280 and the groove 316 of the pin 26 can have various suitable shapes and sizes to achieve the desired pin 26 attachment.
  • the groove 316 can have a generally U-shaped profile and the end of the tang 314 can have a similar shape, h some embodiments, the groove 316 has a generally N-shaped profile and the end of the tang 314 can have a similar shape.
  • the pin-receiving lumen 276 typically includes a pin stop 282 to allow a sufficient length of the pin to be inserted into the lumen 276.
  • the distal end of the pin-receiving lumen 276 forms the opening 304.
  • the tang 314 is disposed midway between the proximal and distal end of the pin-receiving lumen 276.
  • the diameter of the pin-receiving lumen 276 is reduced at its distal end. That is, the tip 302 can have an annular ridge 318 at its distal end where the inner surface of the ridge 318 defines the opening 304.
  • a bone fixation device 25 and insertion tool 200 according to one embodiment of use will now be described with reference to Figures 18-20.
  • a bone drill is selected and the clinician drills a hole 290 (or 22 in Figure 1) through the two pieces of bone.
  • a bone fixation device 25 may be inserted into the insertion tool 200 directly from a package, thereby preferably maintaining the sterility of the fixation device 25.
  • the bone fixation device 25 is inserted into the insertion too by inserting the proximal end of the guide wire 150 into the opening 304 and advanced along the wire receiving lumen 278 until the desired portion of the guide wire 150 is between the wire gripping portions 234 of the levers 230.
  • the proximal end 28 of the pin 26, in turn, is inserted into the opening 304 and advanced along the pin receiving lumen 276 until it contacts or is near the pin stop 282.
  • the guidewire 150 and pin 26 may be propositioned in the insertion tool 200 and packaged together in a sterile package.
  • the distal portion 156 of the guide wire 150 and the distal end 30 of the pin 26 are advanced into the passage 290 until the barbs 50 exit the passage 290.
  • the pin 26 is advanced until the barbs are advanced a sufficient distance into the bone as determined by the clinician.
  • a different tool or the clinician's hand may be used to insert the fixation device 25 into the passage 290.
  • the clinician may apply a proximal force on the finger engagement portions 232 of the insertion tool while holding the outer body 210 relatively stationary.
  • the biasing member 260 provides a sufficient distal force on the biasing end 249 of the central body 250 so that the levers 230 rotate about the pivot pins 236 and can securely grip the guide wire 150 while the central body 250 is generally stationary relative the outer body 210 of the tool 200.
  • the user can provide sufficient proximal force to overcome the bias of the spring 260 and move the levers 230, which are gripping the guide wire 150, thereby moving the central body 250 in the proximal direction relative the outer body 210 of the tool 200.
  • the levers 230 and the central body 250 can be moved in the proximal direction until the proximal end of the biasing end 249 of the central body 250 contacts the distal end of the biasing stop 258.
  • the proximal movement of the levers 230 and central body 250 relative the outer body 210 can be stopped when the bias of the spring 260 overcomes the proximal force applied by the clinician.
  • the levers 230 and central body 250 slide within and along the outer body 210, the levers 230 grip and pull the guidewire 250 while the tip 302 holds the pin 26 stationary relative the outer body 210.
  • the application of a proximal force on the finger engagement portions 232 will preferably result in retraction of the guide wire 150 relative to the pin 26.
  • the guide wire 150 is preferably retracted until the distal portion 156 enters, at least partially, the first portion 160 of the pin 26 (see Figure 9). As such, at least a part of the distal portion 156 of the guide wire 150 becomes locked within the first portion 160 of the pin 26.
  • the distal portion 156 may expand the lever arms 24 beyond their natural relaxed diameter.
  • the insertion tool 200 can be configured such that the maximum distance which the central body 250 is allowed to move (and thus the maximum distance a wire may be pulled) corresponds to a maximum distance necessary for properly deploying the distal portion 156 of the guide wire 150 within the first portion 160 of the pin 26.
  • additional structures may be provided in order to indicate a degree of retraction of the guide wire 150.
  • a viewing window may be provided to allow a clinician to visually verify the grip and the distance of retraction of a guidewire.
  • the proximal anchor 36 may be rotated or otherwise distally advanced (e.g., by proximally retracting the pin) with respect to the pin body 26 so as to seat the proximal anchor 36 snugly against the proximal component 19 of the bone 10.
  • Proximal retraction or distal advancement of the fixation device may require additional tools.
  • TRIAGE.019A filed March 1, 2004 and which is incorporated by reference as part of the specification of this application, or similar devices may be used to distally advance the proximal anchor 36 and/or proximally retract the pin body 26 with respect to the proximal anchor 36.
  • features of such tools may be combined with the insertion tool described herein to produce proximal retraction or distal advancement.
  • the proximal anchor 36 may be positioned on the bone fixation device 25 prior to positioning of the pin body 32 in the hole or passage 290 or 22, or following placement of the pin body 32 within the through passage 290 or 22.
  • proximal anchor 36 Following appropriate tensioning of the proximal anchor 36, the proximal off or otherwise removed. These components may be cut using conventional bone forceps which are routinely available in the clinical setting, or snapped off using designed break points as has been discussed.
  • the tool 200 is preferably adapted to be removably coupled to the bone fixation devices so that the tool 200 can rapidly and conveniently deliver and deploy the fixation device.
  • the tool 200 may also be reused in a similar manners to deliver a plurality of bone fixation devices.
  • a single tool 200 can deliver a plurality of bone fixture devices during a surgical operation.
  • various embodiments described above can be provided in a kit.
  • the kit preferably comprises the tool 200 and at least one bone fixation device.
  • the kit comprises a plurality of bone fixation devices that be rapidly delivered by using the tool 200.
  • the plurality of bone fixation devices can comprise the pin 26, the guidewire 150, and other components described herein.

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Abstract

Cette invention se rapporte à un outil servant à l'insertion d'un dispositif de fixation osseuse. Cet outil comprend, de façon générale, un corps externe allongé et un corps interne allongé, présentant chacun une extrémité proximale, une extrémité distale et un axe longitudinal. Cet outil comporte typiquement à l'extrémité distale du corps externe une partie réceptrice de broche, destinée à recevoir une broche proximale d'un dispositif de fixation osseuse. Cet outil peut en outre comprendre un premier et un second levier montés pivotants sur l'élément interne au niveau d'axes de pivot correspondants, et chacun de ces leviers présente une partie de préhension. Ces leviers comportent de préférence des parties d'engagement de doigts et des parties de préhension de fils métalliques et ils sont de préférence conçus pour être axialement mobiles par rapport au corps externe. Ces leviers sont généralement conçus pour qu'une force proximale exercée sur les parties d'engagement de doigts par rapport au corps externe amène les parties d'engagement de broche à se fermer et à se déplacer en position proximale, de telle sorte qu'un fil de guidage d'un dispositif de fixation osseuse placé entre les parties de préhension de fils métalliques puisse être saisi et tiré en position proximale.
EP04716129A 2003-02-28 2004-03-01 Outil pour dispositif de fixation osseuse Withdrawn EP1605873A4 (fr)

Applications Claiming Priority (5)

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PCT/US2004/006125 WO2004078220A2 (fr) 2003-02-28 2004-03-01 Outil pour dispositif de fixation osseuse

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WO2004078220A3 (fr) 2004-12-23
EP1605873A2 (fr) 2005-12-21
WO2004078220A9 (fr) 2004-10-28
WO2004078220A2 (fr) 2004-09-16
JP2006519087A (ja) 2006-08-24
AU2004218498A1 (en) 2004-09-16

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