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US20070173835A1 - Intramedullary implant for fracture fixation and method of using the same - Google Patents

Intramedullary implant for fracture fixation and method of using the same Download PDF

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Publication number
US20070173835A1
US20070173835A1 US11/331,738 US33173806A US2007173835A1 US 20070173835 A1 US20070173835 A1 US 20070173835A1 US 33173806 A US33173806 A US 33173806A US 2007173835 A1 US2007173835 A1 US 2007173835A1
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Prior art keywords
implant
receptor
fragment
bone
tip
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Abandoned
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US11/331,738
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Robert Medoff
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Individual
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Individual
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Priority to US11/331,738 priority Critical patent/US20070173835A1/en
Assigned to TELLMAN, LARS G., MEDOFF, DAVID reassignment TELLMAN, LARS G. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MEDOFF, ROBERT J.
Priority to EP07100193A priority patent/EP1808143A1/fr
Priority to AU2007200086A priority patent/AU2007200086A1/en
Publication of US20070173835A1 publication Critical patent/US20070173835A1/en
Priority to US12/048,794 priority patent/US8216238B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1782—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hand or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1717—Guides or aligning means for drills, mills, pins or wires for applying intramedullary nails or pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1725—Guides or aligning means for drills, mills, pins or wires for applying transverse screws or pins through intramedullary nails or pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
    • A61B17/7216—Intramedullary devices, e.g. pins or nails for bone lengthening or compression
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
    • A61B17/7291—Intramedullary devices, e.g. pins or nails 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
    • 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 or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches

Definitions

  • This invention relates to an intramedullary fracture fixation implant and particularly to a fracture fixation implant for fixation of distal fractures of the radius in which the implant is adopted to be axially inserted and secured within the intramedullary canal portions of the bone segments on opposing sides of the fracture.
  • the invention further comprises a method of fracture fixation with the intramedullary fracture fixation implant of the present invention.
  • Fractures that occur in proximity to a joint can be difficult to treat. Although plates, screws and pins on the surface of the bone can provide fracture stability, often the close proximity of tendons to the surface of the bone can result in soft tissue irritation and even tendon rupture that can compromise the outcome. Intramedullary fixation of fractures, with or without cross-locking screws, is well known to reduce the problem of soft tissue irritation by placing the bulk of the implant within the bone itself.
  • intramedullary fixation can provide fracture stability because of either a tight fit of the rod within the bone or fixation from locking screws that cross through the bone and rod.
  • Traditional intramedullary rods are not well suited for fixation of a fracture in proximity to the end of the bone.
  • the distal end of the radius is extremely wide with soft cancellous bone within the intraosseous space and only thin weak cortical bone that surrounds the tubular structure; the strongest bone at the distal end of the radius is the thick subchondral bone that extends behind the articular surface and is under the tip of the radial styloid.
  • the implant since the implant is inserted through this large defect in the distal fragment, it is not possible for the end of the implant to be used to provide axial support to the fragment; instead, the implant is totally dependent on the resistance of the thin cortical bone to translational movement and the purchase of transverse locking screws in the soft, often osteoporotic, metaphyseal bone. As a result, loss of radial length can easily occur, resulting in protrusion of the nail from the insertion site as well as deformity and loss of function.
  • Standard intramedullary rods use cross locking screws to prevent the small distal fragment from losing length. Examples of standard intramedullary rods are shown in U.S. patent application Ser. No. 10/377,255 to Warburton and entitled Intramedullary Interlocking Fixation Device for the Distal Radius (U.S. Publication No. 2004/0010255) and U.S. patent application Ser. No. 09/975,514 to Putnam and entitled Intramedullary Rod for Wrist Fixation (U.S. Publication No. 2003/0073999). Because these screws are placed across the nail into the metaphyseal bone of the distal fragment, they are loaded at their tip by the compressive loads that occur across the wrist. This places a significant torque on the screw, which can lead to increased implant loads and can result in breakage, cutout through the bone, or loosening of the screw. In turn these can result in loss of length, deformity, and impaired function of the wrist.
  • distal radius is made of relatively soft cancellous bone, there is little resistance to side-to-side translational displacements by a standard intramedually nail, particularly since the nail is placed through a hole made in the bone and courses to lie entirely within the metaphyseal cavity. This results in poor support of the fragment by the nail itself, requiring the majority of resistance to displacement to be taken up by the distal crossing screws.
  • Intramedullary implants are inserted into a tubular bone from one end and driven to the opposite end.
  • the implant is inserted at the proximal end of the bone and driven in an ante grade direction into the distal end of the long bone.
  • the implant is inserted at the distal end of a long bone and driven in a retrograde direction into the proximal end. Because the direction of insertion is always uni-directional, current intramedullary designs do not permit fixation both above and below the site of insertion of the implant.
  • existing intramedullary implants are designed for insertion in a single direction only (either ante grade or retrograde), these implants are always connected to a driver at one end.
  • An object of the current invention is to provide an intramedullary implant that can be inserted without the creation of a new, large defect in either fragment, but particularly the small distal fragment, thereby avoiding the risk of additional fracture comminution caused from the insertion procedure itself.
  • a further object of the invention is to provide an intramedullary implant that can be inserted without the necessity of driving the implant along a single axis into the bone from one end, thereby avoiding the problem of positioning the insertion hole in the bone directly over the end of the implant and resulting in the inability of the implant to support the distal fragment axially and poor resistance to shortening.
  • a further object of the invention is to provide an intramedullary implant that resists loss of length by providing axial support along its tip to the strong subcortical bone at the end of a fragment.
  • a further object of the invention is to provide an intramedullary implant that can both resist loss of length through axial support of an unstable bone fragment as well as achieve rotational support from cross locking screws in the unstable fragment.
  • a further object of the invention is to allow a provision for a relatively smooth tip to be situated centrally within the conical morphology of the tip of the radial styloid, abutting the strong subchondral surface at the end of the bone.
  • the tip is captured by the concave conical bone at the radial styloid, thereby resisting translational movement of the distal fragment by the nail itself. This is comparable to the way a tent is supported by a tent pole.
  • a further object of the invention is to provide a method of fixation that is simple to apply, allows insertion of an intramedullary implant to span a fracture defect by insertion of the implant through the fracture site itself, with a minimal incision or even subcutaneous approach.
  • a further object of the invention is to provide instrumentation that allows an intramedullary implant to be inserted through a fracture defect into an intramedullary position, spanning the fracture defect and achieve purchase in the fragments on both sides of a fracture.
  • a further object of the invention is to provide a means of insertion that allows an intramedullary implant to be inserted in one direction through a relatively central insertion site in the bone, and then displaced in the opposite direction to allow bone purchase on both sides of the insertion site.
  • a further object of the present invention is to provide instrumentation that cooperates with areas of connection on an intramedullary implant in order to allow the implant to be axially displaced in a direction that is opposite of the initial insertion of the implant into the bone.
  • FIG. 1 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention
  • FIG. 2 is a front elevation view of the intramedullary fixation device according to the present invention.
  • FIG. 3 is a side elevation view of the intramedullary fixation device according to the present invention.
  • FIG. 4 is a cross-section view of the intramedullary fixation device according to the present invention taken along section line 4 - 4 in FIGS. 2 and 17 ;
  • FIG. 5 is a cross-section view of the intramedullary fixation device according to the present invention taken along section line 5 - 5 in FIGS. 2 and 17 ;
  • FIG. 6 is an elevation view of a component of the intramedullary fixation device of the present invention.
  • FIG. 7 is an elevation view of a component of the intramedullary fixation device of the present invention.
  • FIG. 8 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 9 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 10 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 11 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 12 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 13 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 14 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 15 is a schematic view of an x-ray showing the intramedullary fixation device of the present invention inserted within an intramedullary canal;
  • FIG. 16 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 17 is a front elevation view of another preferred embodiment of an intramedullary fixation device according to the present invention.
  • FIG. 18 is a side elevation view of another preferred embodiment of an intramedullary fixation device according to the present invention.
  • FIG. 19 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 20 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 21 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 22 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 23 is a schematic view of a step in a method for fixing a bone fracture using the intramedullary fixation device of the present invention.
  • FIG. 24 is a schematic view of an x-ray showing the intramedullary fixation device of the present invention inserted within an intramedullary canal;
  • FIGS. 25-28 are elevation views of a second preferred embodiment of the present invention.
  • FIGS. 29-32 are elevation views of mechanisms for positioning the implant of the present invention.
  • a fracture fixation device which comprises an intramedullary rod for placement into a fracture defect.
  • a bone 10 such as the radius
  • a fracture 12 is present at its distal end and forms a stable first, proximal bone fragment 14 , and an unstable second, distal bone fragment 16 .
  • the second bone fragment 16 has an end portion 18 , comprising, for example, the radial styloid 20 when the fracture is a distal radius fracture.
  • the fracture 12 as illustrated in FIG. 1 , is in proximity to the end portion 18 of the second fragment 16 of the bone 10 .
  • the fracture can also be displaced proximally or centrally on the bone without altering the inventive concept.
  • the general design of the present fracture fixation implant is applicable to other locations, such as the end of the humerus, ulna, tibia, fibula, femur or other long bones comprising an intramedullary canal, without restricting the spirit or scope of the invention.
  • an intramedullary fracture fixation implant 22 is shown.
  • the implant 22 comprises a first end 24 and a second end 26 .
  • the implant 22 is largely banana-shaped and has a curvilinear profile when viewed from the anterior-posterior view and a generally linear profile when viewed from the lateral view ( FIG. 3 ).
  • the implant 22 is composed of any suitable material that exhibits the appropriate mechanical and biological compatibility with the fraction fixation.
  • the implant is composed of surgical grade stainless steel, surgical grade titanium, or a surgical grade titanium alloy. In other preferred embodiments, any surgical grade implantable material with sufficient strength and stiffness characteristics can be used.
  • the first end 24 of the implant 22 may comprise at least a first receptor configured to receive a fastener for securely and releasably mating the implant to the shaft of the bone 10 .
  • a plurality of receptors 34 , 36 , 38 , 40 are used, each of the plurality of receptors comprising a screw hole having an open-ended channel extending across the width of the first end 24 of the implant 22 .
  • the number of receptors required can vary and is dependent on the particular application for the implant and desired or required amount of the fixation of the first end to the first fragment.
  • the cross section of the first end 24 is in the form of a square with curved corner portions ( FIG. 4 ).
  • the first, second, third, and fourth screw holes 34 , 36 , 38 , 40 are all disposed on the same surface of the implant 22 .
  • This configuration enables the insertion of fasteners into the receptors from a dorsal approach, enabling avoidance of tendons, nerves, or major arteries in the area.
  • the fasteners are captured by and extend through the receptors 34 , 36 , 38 , 40 and into the shaft of the first fragment 14 ( FIG. 1 ) to the secure the implant 22 to the bone 10 .
  • the modified square cross-section also assists in centering a fastener into a corresponding receptor.
  • first end 24 can be formed into a square or circular cross-section.
  • a means for self-centering the fasteners may be incorporated with each receptor, such as a counter bore surrounding each receptor or a concave entry portion for each receptor.
  • the receptors are disposed radially around the perimeter of the first end 24 .
  • receptors 34 , 36 , 38 , 40 can be angled medial to lateral, arranged in an oblique orientation, or a combination of these configurations.
  • the number of receptors may also vary to provide for secure fixation of a longer fracture, or a smaller implant for simplified fixation in simple fractures.
  • the receptors 34 , 36 , 38 , 40 are threaded and are configured to receive and capture fasteners comprising bone screws.
  • unthreaded receptors 34 , 36 , 38 , 40 can be utilized without affecting the performance of the implant 22 .
  • the fasteners comprise a peg, rivet, screw, or any other suitable fastener for engaging an unthreaded receptor.
  • the second end 26 of the implant 22 has a substantially round cross-section ( FIG. 5 ) and may comprise a longitudinal receptor 46 at the tip 32 for receiving and capturing a fastener configured to mate the implant to the strong cortical bone at the end portion 18 , and specifically in the radial styloid 20 of the second fragment 16 when the implant 22 is used in the fixation of a distal radius fracture.
  • the tip 32 of the implant 22 the tip 32 is contoured to largely conform to the contour of the endosteal surface of the radial styloid 20 of the radius 10 .
  • the surface contour of the tip 32 is large enough to spread the axial load on the implant at the tip 32 over a large contact area. This provides excellent support and strength to the second fragment 16 to resist loss of length of the bone 10 during the healing of the fracture, as well as the biomechanical advantage of avoiding excessive loading on the implant 22 , that could result in breakage or cut-out.
  • the tip 32 is further configured to comprise a leading edge for driving the implant into position within the intramedullary space 52 b of the bone 10 .
  • the tip 32 is configured to largely conform to the endosteal surface or end portion of the second fragment of the bone to be fixed by the implant 22 .
  • the longitudinal receptor 46 comprises a threaded screw hole comprising an aperture and threaded channel bored into the tip 32 .
  • the longitudinal fastener is a radial styloid bone screw 49 ( FIG. 14 ).
  • the diameter of the second end 26 of the implant is significantly larger than the diameter of the longitudinal receptor 46 in order to allow the implant to support axial loading at the tip 32 during fracture reduction and fixation.
  • the tip 32 may also comprise a cannulated channel 47 that extends from the tip 32 through a segment of the second end 26 of the implant 22 .
  • the channel 47 is configured to receive and enable passage of a guide wire 64 ( FIG. 16 ) from the radial styloid 20 of the second fragment 16 to guide the implant 22 into proper position.
  • the cannulated channel 47 is integrally formed and coaxially aligned with the longitudinal receptor 46 .
  • the cannulated channel 47 may also be formed independent of the longitudinal receptor 46 .
  • the second end 26 may also comprise at least one cross-locking receptor for securely and releasably mating the implant 22 to the second fragment 16 .
  • a first and second cross-locking receptor 42 , 44 are used for receiving and capturing a fastener.
  • Each receptor 42 , 44 comprises a screw hole having an open-ended channel extending diametrically through the second end 26 of the implant 22 .
  • the cross-locking receptors 42 , 44 are preferentially, but not necessarily, radially spaced apart at an angular distance from each other.
  • the cross-locking receptor 42 is directed volarly at angle of approximately 17 degrees to the palm in respect to the coronal plan, and is approximately 10 degrees proximally inclined.
  • the cross-locking receptor 44 is directed dorsally at an angle of approximately 12 degrees with respect to the coronal plan and is approximately 8 degrees proximally inclined.
  • this specific angular displacement of the cross-locking receptors 42 , 44 is disclosed for exemplary purposes only. This arrangement enables engagement of the volar subchondral bone of the second fragment 16 by a fastener that is captured by and extending through the first receptor 42 and engagement of the dorsal subchondral bone of the second fragment 16 by a fastener that is captured by and extends through the second receptor 44 .
  • the implant 22 is also provided with a radial driver assembly configured to attach a driver 58 or alignment jig to the implant 22 to facilitate insertion of the implant 22 through an entry point 48 on the bone 10 and into the intramedullary space 52 a of the first fragment 14 , and to allow for positioning of the implant 22 within the intramedullary space 52 a .
  • the cross-locking receptor 42 is also configured to releasably capture the driver 58 , as will be described below.
  • the externally threaded end 60 of the driver 58 releasably engages the corresponding internal threads in the receptor 42 to provide a handle for insertion of the implant 22 into the intramedullary space 52 a .
  • the driver can take the form of a peg that is received by a corresponding receptor on the second end 26 , or alternatively, the driver can include a tongue-like end that is received by a groove in the second end 26 .
  • An axial driver assembly is provided to enable the implant to be displaced across the fracture site 12 from the first intramedullary space 52 a into the intramedullary space 52 b of the second fragment 16 until the tip 32 abuts the end portion 18 of the second fragment 16 , e.g. the endosteal surface of the radial styloid 20 when the implant 22 is used during fixation of a distal radius fracture.
  • the longitudinal receptor 46 is also configured to receive and capture a driver 50 ( FIG. 6 ) or alignment jig to facilitate drawing the implant into the intramedullary space 52 b .
  • the externally threaded end 56 of the driver 50 releasably mates with the corresponding internal threading of the longitudinal receptor 46 .
  • the driver 50 is used as a handle to draw the implant 22 towards the radial styloid 20 ( FIG. 12 ).
  • the driver 50 has a section of reduced diameter above the terminal thread enabling angular adjustment of driver 50 within the hole drilled through the radial styloid 20 to enable alignment of the driver tip 56 with the threads in longitudinal receptor 46 and to allow the two pieces to be connected and screwed together.
  • the driver 50 is removed from the longitudinal receptor 46 and can be replaced by a fastener, such as a radial styloid screw, as described above.
  • the driver can take the form of a peg that is received by a corresponding receptor on the second end 26 , or alternatively, the driver can include a tongue-like end that is received by a groove in the tip 32 .
  • FIGS. 17 and 18 show a second preferred embodiment of the present invention wherein the general shape of implant 22 is S-shaped ( FIG. 17 ) when viewed from the anterior-posterior view and generally linear when viewed from the lateral view ( FIG. 18 ).
  • the implant of the second preferred configuration has the same cross-sectional geometry as the banana-shaped implant previously described.
  • the use and configuration of: at least a first receptor, and preferably a plurality of receptors 34 , 36 , 38 , 40 , disposed on the first end 24 of the implant 22 ; zero, one or more cross-locking receptors at the second end 26 of the implant 22 , and preferably a plurality of cross-locking receptors 42 , 44 ; a longitudinal receptor 46 at the tip 32 of the second end 26 ; and receptors for axial and radial driver assemblies is also the same as described above.
  • FIGS. 1 , 8 - 15 , and 19 - 24 show a method of the using the intramedullary fracture fixation implant 22 of both the first and second preferred embodiments of the present invention for reduction and fixation of a distal radius fracture.
  • the same methodology may be used to reduce and fix fractures of bones other than the radius.
  • an entry site 48 for the implant 22 is formed in the bone 10 .
  • a biting tool or reamer (not shown) is used to extend an opening 48 from the fracture site 12 proximally to allow insertion of the implant 22 . While extending the opening 48 from the fracture site 12 extends the already unstable fracture site, it does not add a new hole in the first fragment 14 .
  • a new point of entry 48 of the implant into the intramedullary canal 52 may be formed in the bone 10 .
  • an aperture 62 is then formed in the tip of the radial styloid 20 of the second fragment 16 .
  • the aperture 62 is formed by a drill, awl or pin 63 .
  • a guide 65 may also be used to confirm the positioning of the drill, awl, or pin 63 at the proper entry location and to prevent wrapping of soft tissues structures as the aperture 62 is formed.
  • the aperture 62 is at least of a diameter to accommodate the driver 50 ( FIG. 6 ) and longitudinal fastener 49 ( FIG. 14 ) that are received and captured by the longitudinal receptor 46 , as was described previously; typically this may range in size between 0.5 mm to 5 mm.
  • a guide wire or ribbon 64 is inserted through the aperture 62 and into the intramedullary space 52 b ( FIG. 9 ). As is seen in FIG. 16 , the guide wire or ribbon 64 is received by the cannulated channel 47 .
  • FIG. 9 also shows the use of an impactor or cannulated flexible reamer 66 to develop a pathway in the intramedullary space 52 b of the second fragment 16 .
  • a path 68 through the soft metaphyseal bone is made to enable abutment of the tip 32 of the implant 22 against the strong subchondral bone surface of the radial styloid 20 .
  • a driver 58 or alignment jig is releasably mated with the implant 22 at the cross-locking receptor 42 and the implant 22 is inserted through the entry point 48 into the intramedullary space 52 a of the first fragment 14 .
  • the second driver 50 is inserted through the aperture 62 in the radial styloid 20 , through the path 68 , and is releasably mated with the implant at the longitudinal receptor 46 in the tip 32 .
  • the driver 58 can be used to stabilize the implant and prevent rotation of the implant 22 as the driver 50 is screwed into place.
  • the driver 58 or alignment jig is then removed from the cross-locking receptor 42 to enable the implant to be displaced across the fracture site 12 .
  • the implant 22 is then drawn into the intramedullary space 52 b of the second fragment 16 until the tip 32 of the implant 22 abuts the endosteal surface of the subchondral bone under the radial styloid 20 . Since the tip 32 is larger than the aperture 62 in the radial styloid 20 , the tip 32 of the implant provides axial support to maintain radial length without the obligate torque that occurs when the resistance to loss of radial length is provided exclusively by cross fixation members. In addition, the congruence of the surface contour of the tip 32 to the endosteal surface of the radial styloid 20 adds further constraint to resist side-to-side movement of the second fragment 16 .
  • the implant 22 is positioned with the intramedullary space 52 a of the first fragment 14 by displacing the first end 24 in a first direction and then displacing the implant in a second direction, substantially opposite the first direction, to place the second end 26 into the intramedullary space 52 b of the second fragment 16 .
  • the implant 22 is positioned at the proper angular position and a drill guide 60 having a first and second end 62 , 64 is positioned where the first end 62 of the drill guide 60 overlaps the first end 24 of the implant 22 on the exterior of the bone 10 and the second end 64 of the drill guide 60 is aligned with the second end 26 of the implant 22 .
  • the first end 62 of the drill guide 60 comprises apertures 66 , 68 , 70 , 72 that align with the receptors 34 , 36 , 38 , 40 at the first end 24 of the implant 22 .
  • the second end 64 comprises drill guides 74 , 76 that may be used to bore holes in the bone 10 and/or form the cross-locking receptors 42 , 44 .
  • the implant 22 may comprise an alignment mechanism to orientate the drill guide 60 and align apertures 66 , 68 , 70 , 72 and receptors 34 , 36 , 38 , 40 and properly position the drill guides 74 , 76 .
  • the orientation mechanism for the alignment jig may be integrally formed with one of the cross-locking receptors 42 when the cross-locking receptors 42 , 44 are formed in the implant 22 prior to insertion of the implant within the bone 10 and comprises diametrically spaced slots on 54 a , 54 b opposing sides of the cross-locking receptor 44 .
  • the orientation mechanism may be a receptor on the side of the implant or may be attached to second driver 58 .
  • Drilling holes into the bone through the apertures 66 , 68 , 70 , 72 will form concentric channels with the receptors 34 , 36 , 38 , 40 for receiving fasteners to secure the implant 22 to the first fragment 14 .
  • the first guide 74 is used to bore the first receptor 42 into the second end 26 , and the second guide 76 aligns to form the second receptor 44 .
  • the drill guide is removed and the cross-locking fasteners 78 , 80 are secured in place.
  • the cross-locking fasteners 78 , 80 are shown to extend through the implant and across the intramedullary space 52 b of the second fragment 16 , this configuration is for exemplary purposes only.
  • fasteners that only extend into the second end 26 of the implant 22 such as pegs, rivets, and/or shorter bone screws, can be utilized.
  • the axial driver is removed from the longitudinal receptor 46 either before or after placement of the cross-locking screws, and replaced by the longitudinal fastener 49 , e.g.
  • radial styloid bone screw when fixing a distal radius fracture. This locks the tip 32 of the implant 22 into abutment with the subchondral bone under the radial styloid 20 and secures the second end 26 of the implant 22 to the end portion 18 of the second fragment 16 . With firm fixation of the implant 22 in the second fragment 16 , the fracture is brought out to length and reduced.
  • the fracture reduction is secured by insertion of fasteners 84 , 86 , 88 , 90 through the bone 10 , and into engagement with the receptors 34 , 36 , 38 , 40 in the first end 24 .
  • the fasteners 84 , 86 , 88 , 90 may extend through the receptors 34 , 36 , 38 , 40 and into the surrounding bone of the first fragment 14 .
  • receptors 34 , 36 , 38 , 40 may be threaded and allow the use of unicortical locking screws. Fixation of the implant 22 to the first fragment 14 results in the support of the second fragment 16 , in a manner similar to a tent pole supporting a tent; this prevents collapse of the second fragment 16 , with resultant loss of length of the bone 10 .
  • any number of fixation members placed in the second end may be applicable depending on the site of application and the size of the implant.
  • the fixation members may be torsionally disposed to one another to allow more spread to the fixation of the second fragment.
  • the first receptor 42 is angled to purchase the volar rim of the second fragment 16 , placing its entry site dorsally and avoiding contact with the first dorsal compartment tendons; the second receptor 44 is angled distally and dorsally to engage the dorsal ulnar corner of the second fragment 16 .
  • four fasteners are shown to secure the implant 22 to the first fragment 14 , any number of fasteners could be used and would not depart from the spirit and scope of the invention.
  • the implant may be removed once the fracture site has healed by using a hollow drill bit to core out a section of the radial styloid to enable extraction through the hole. Because the fracture site will have healed over, the implant cannot usually be extracted through the entry site.
  • FIGS. 25-28 show a third preferred embodiment of the present invention, where the implant 22 comprises a first and second portion 92 , 94 that secured together to form a single unit. Once secured together, the first portion 92 comprises the first end 24 of the implant 22 and the second portion 94 comprises the second end 26 of the implant. The first portion 92 has a concave, bent curvature with at least a first receptor 96 for receiving a fastener.
  • the first end 24 comprises a plurality of receptors 96 , 98 , 100 .
  • the first receptor 96 comprises a slotted aperture enabling fixation of the first end 24 of the implant 22 with a fastener, but also enabling proximal or distal fine-tuning of the fracture reduction when the fastener is only loosely placed within the receptor 96 .
  • the second and third 98 , 100 receptors consist of screw holes comprising an open-ended channel extending through the width of the implant 22 . As is seen in FIG. 25 , the plurality of receptors 96 , 98 , 100 are linearly aligned.
  • the receptors 96 , 98 , 100 may also be radially disposed around the perimeter of the first end 24 to facilitate a cross-locking arrangement.
  • the head 102 of the first end 24 is configured to be the leading edge or drive surface of the first end 24 as it enters the bone through the extended portion 48 of the fracture site 12 ( FIG. 1 ) and is positioned within the intramedullary space 52 a.
  • the second end 26 of the implant 22 comprises a support peg 103 configured to abut and support the endosteal surface of the radial styloid portion 20 of the bone 10 .
  • the support peg 103 has a substantially round cross-section and a tip 32 having the same general shape and contour of the endosteal surface of the cortical bone at the radial styloid 20 .
  • the tip 32 has a generally cone-like shape with a flattened or rounded end. This provides excellent support and strength to the second fragment 16 to resist loss of length of the bone 10 during the healing of the fracture 12 .
  • the tip 32 of the support peg 103 comprises the leading edge or drive surface of the second end 26 when the second end 26 is inserted through the entry point 48 , which in this figure comprises the extended portion of the fracture site 12 ( FIG. 1 ) and into the intramedullary space 52 b of the second fragment 16 , as well as serving the load bearing function described above.
  • the second end 26 also comprises an interface for engaging the first end 24 of the implant 22 to form a unitary component.
  • the interface between the first and second ends 24 , 26 of the implant 22 is a tongue and groove assembly.
  • the first end 24 comprises a flattened, tongue portion 106 with a bore 108 extending there through.
  • the second end 26 comprises a first and second arm 110 , 112 equidistantly spaced apart across their lengths to form a channel 114 configured to receive the tongue portion 106 of the first end 24 .
  • Each arm 110 , 112 comprises a concentrically aligned bore 116 , 118 for receiving a fastener.
  • the bores 108 , 116 , 118 align to form a through hole 120 for receiving a fastener 121 to secure the first and second ends 24 , 26 together.
  • the bores 108 , 116 , and 118 are threaded and configured to receive a threaded fastener such as a screw.
  • a peg or rivet may also be used to secure the first and second ends 24 , 26 .
  • the bores 116 , 118 may be slotted to provide for additional distal or proximal fine tuning of the placement of the implant 22 when a fastener 121 is loosely placed within the through hole 120 .
  • Other connections are also possible, such as a conical trunion that mates with a morse taper assembly (not shown) as is commonly known and used with modular prosthetic implants, or a captured channel or slot as is commonly known and used with sliding compression hip screws.
  • the second end 26 may also comprise a longitudinal receptor 46 at the tip 32 for receiving and capturing a fastener configured to mate the implant to the strong cortical bone in radial styloid 20 of the distal fragment 16 .
  • the longitudinal receptor 46 comprises a threaded screw hole comprising an aperture and threaded channel bored into the tip 32 .
  • the longitudinal fastener is a radial styloid bone screw, such as the radial styloid bone screw 49 shown in FIG. 14 .
  • other suitable fasteners may also be used, such as pegs or rivets.
  • the diameter of the second end 26 of the implant is significantly larger than the diameter of the longitudinal receptor 46 in order to allow the implant to support axial loading during fracture reduction and fixation.
  • the tip 32 may also comprise a cannulated channel 47 that extends from the tip 32 through a segment of the second end 26 of the implant 10 .
  • the channel 47 is configured to receive and enable passage of a guide wire extending from the radial styloid of the second fragment to guide the implant 22 into proper position.
  • the cannulated channel 47 is integrally formed and coaxially aligned with the longitudinal receptor 46 .
  • the cannulated channel 47 may also be formed independent of the longitudinal receptor 46 .
  • the second end 26 may also comprise a first and second cross-locking receptor 42 , 44 for receiving and capturing a fastener.
  • Each receptor 42 , 44 comprises a screw hole having an open-ended channel extending diametrically through the second end of the implant 22 .
  • the first and second cross-locking receptors 42 , 44 are radially spaced apart from each other. This arrangement enables engagement of the volar subchondral bone of the second fragment 16 by a fastener that is captured by and extending through the first receptor 42 and engagement of the dorsal subchondral bone of the second fragment 16 by a fastener that is captured by and extends through the second receptor 44 .
  • the implant 22 is inserted within the intramedullary space of the bone in a similar manner to methodology described with respect to the first and second embodiments, with the added step of placing and inserting the first and second ends 24 , 26 of the implant 22 into the intramedullary space of the bone 52 in two separate steps and then securing the components together to form a unitary structure.
  • the first end is 24 is inserted through the entry site 48 into the intramedullary space 52 a of the first fragment 14 .
  • a fastener is placed loosely from dorsal to volar in the first, slotted receptor 96 in the first end 24 to fix the first end 24 to the first fragment 14 , but still enabling fine-tuning of the implant, and consequently the fracture reduction.
  • the second end 26 is inserted through the entry point 48 and into the intramedullary space 52 b of the second fragment 16 .
  • a fastener 122 is inserted within the through hole 120 and loosely placed to enable additional fine tuning of the fracture reduction. Fasteners are then placed within the receptors in the second end 26 to secure the second end 26 to the second fragment 16 . Once the fracture has been properly reduced, the fastener loosely placed in the first receptor 96 is tightened and additional fasteners may be placed within the second and third receptors 98 , 100 , to securely fasten the first end 24 to the first fragment 14 .
  • the implant 22 has been positioned within the intramedullary space of the bone by utilizing a plurality of drivers with threaded ends to engage threaded receptors disposed on the implant.
  • FIGS. 29-32 show alternative, yet preferred assemblies and structures for properly positioning the implant of the present invention by advancing the implant across the intramedullary space of the fractured bone.
  • the periphery of the implant 22 comprises a serrated surface 110 for engaging the teeth 112 , 114 of a ratcheting mechanism 116 .
  • the serrated surface 110 comprises a plurality of teeth each having an angled wall 120 a orientated upwards towards the tip 32 of the implant 22 and a base wall 120 b .
  • FIG. 21 when the ratcheting mechanism 116 is in the open position, its teeth 112 , 114 engage a first and second tooth of the serrated edge 110 where the first and second tooth are separated by an intervening tooth.
  • the ratcheting mechanism 116 closes by drawing handle 117 b towards handle 117 a along the direction shown by arrow 123 b .
  • the implant 22 comprises a ribbed surface 124 .
  • a positioning instrument 125 with a rotating gear 126 is used to advance the implant in the direction of arrow 128 a .
  • the gear 126 rotates in the direction of arrow 128 b
  • the implant is advanced.
  • the implant 22 also includes at least a first channel 130 extending in a parallel direction to the ribbed surface 124 .
  • the channel 130 is configured to receive a guide 132 on the positioning instrument 125 that aids in keeping the positioning instrument 125 in engagement with the implant 22 .
  • FIG. 32 shows an assembly wherein the implant 22 comprises at a first track disposed longitudinally on the implant.
  • a first 134 and second (not shown) track on opposing sides of the implant 22 are utilized.
  • this may be a single track with a tongue in groove surface (not shown).
  • the tracks are configured to receive at least a first tongue member 136 of a positioning instrument 138 .
  • Closing the positioning instrument by drawing handle 139 b towards handle 139 a causes the tongue member 136 to engage the track 134 and hold the implant 22 .
  • a hole or slot 140 is disposed on the surface of the implant and is configured to receive a suture or flexible wire or ribbon 142 associated with positioning instrument 138 .
  • the suture or wire 142 overlies a pulley 144 and is attached to a lever 141 .
  • the lever 141 is moved from a first position to a second position, the suture or wire 142 is pulled and displaces the implant 22 across the fracture site 12 into position in the second fragment 16 .

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US11/331,738 2006-01-13 2006-01-13 Intramedullary implant for fracture fixation and method of using the same Abandoned US20070173835A1 (en)

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US11/331,738 US20070173835A1 (en) 2006-01-13 2006-01-13 Intramedullary implant for fracture fixation and method of using the same
EP07100193A EP1808143A1 (fr) 2006-01-13 2007-01-05 Implant intramedullaire destiné a la réparation d'une fracture
AU2007200086A AU2007200086A1 (en) 2006-01-13 2007-01-09 Intramedullary implant for fracture fixation and method of using the same
US12/048,794 US8216238B2 (en) 2006-01-13 2008-03-14 Method of using an intramedullary implant for fracture fixation

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EP1808143A1 (fr) 2007-07-18
AU2007200086A1 (en) 2007-08-02
US8216238B2 (en) 2012-07-10

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