WO2009139758A2 - Intramedullary device assembly and associated method - Google Patents

Intramedullary device assembly and associated method Download PDF

Info

Publication number
WO2009139758A2
WO2009139758A2 PCT/US2008/060294 US2008060294W WO2009139758A2 WO 2009139758 A2 WO2009139758 A2 WO 2009139758A2 US 2008060294 W US2008060294 W US 2008060294W WO 2009139758 A2 WO2009139758 A2 WO 2009139758A2
Authority
WO
WIPO (PCT)
Prior art keywords
bone
intramedullary device
engagement member
guide
bone engagement
Prior art date
Application number
PCT/US2008/060294
Other languages
French (fr)
Other versions
WO2009139758A3 (en
WO2009139758A8 (en
Inventor
Scott G. Edwards
Ronald Arthur Yapp
Original Assignee
Edwards Scott G
Ronald Arthur Yapp
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 Edwards Scott G, Ronald Arthur Yapp filed Critical Edwards Scott G
Priority to CN2008801296513A priority Critical patent/CN102083374A/en
Priority to CA2720116A priority patent/CA2720116A1/en
Priority to EP08745818A priority patent/EP2282686B1/en
Priority to JP2011502927A priority patent/JP2011516150A/en
Priority to BRPI0822414-5A priority patent/BRPI0822414A2/en
Priority to AU2008356192A priority patent/AU2008356192B2/en
Publication of WO2009139758A2 publication Critical patent/WO2009139758A2/en
Publication of WO2009139758A3 publication Critical patent/WO2009139758A3/en
Publication of WO2009139758A8 publication Critical patent/WO2009139758A8/en
Priority to IL208398A priority patent/IL208398A0/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary pins, nails or other devices
    • A61B17/7216Intramedullary pins, nails or other devices for bone lengthening or compression
    • A61B17/7225Intramedullary pins, nails or other devices for bone lengthening or compression for bone compression
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1725Guides or aligning means for drills, mills, pins or wires for applying transverse screws or pins through intramedullary nails or pins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter

Definitions

  • the present invention relates to intramedullary devices for repairing bone defects and, more specifically, to intramedullary device assemblies for providing fixation, compression, and/or stabilization of the diaphysis or metaphysis of a long bone or periarticular bone.
  • Intramedullary devices such as nails, rods, or pins, are often used in the medical field to treat fractures of long bones, such as in the ulna and femur. These intramedullary devices also may be used to treat periarticular fractures, such as in the distal radius and proximal humerus. Such devices are typically designed to be inserted into the medullary canal of the fractured bone and generally are fastened to the bone segments on either side of the fracture to stabilize the bone and promote proper healing. In some cases, the bone segments on either side of a fracture are spaced apart and must be brought closer together at the fracture to promote healing.
  • Devices have been proposed that provide compression to such bone fractures by fixing the intramedullary device to one bone segment and then moving the free bone segment towards the fixed bone segment by way of compression applied to the end of the free bone segment.
  • the free bone segment is then secured to the intramedullary device and the fracture is allowed to heal.
  • these devices may not engage the end of the free bone segment in a manner that takes into account the bone structure at the end of the bone segment or provide balanced compression.
  • the structure of some bones include a relatively hard outer shell comprised of cortical bone, and a relatively softer portion within the shell comprised of cancellous bone.
  • the cortical bone can become quite thin and brittle.
  • care must be taken when applying a compressive force to the end of the bone not to fracture or damage the cortical bone. Applying the compressive force in an unbalanced fashion to the end of the bone can be damaging to the cortical bone and may not provide a balanced compressive force at the fracture site.
  • the present invention generally relates to an intramedullary device assembly for applying and maintaining compression of a bone.
  • the intramedullary device assembly includes a bone engagement member that is movable along a bone engagement member guide and includes bone engagement points where at least one of the bone engagement points is movable along an axis of the bone engagement member guide relative to another bone engagement point.
  • the bone engagement member may be advanced along the bone engagement member guide by a compression member of the assembly and, in one exemplary embodiment, the bone engagement member can tilt to engage the end of the bone.
  • the intramedullary device assembly may be easily inserted into the medullary canal of the bone at a joint, such as at the olecranon or the ankle malleolus, and is configured to provide appropriate and balanced compression of the bone to promote healing.
  • the intramedullary device assembly includes an intramedullary device, a bone engagement member guide, a compression member, and a bone engagement member.
  • the intramedullary device is configured to be inserted into the medullary canal of the bone and fastened to the bone on either side of the defect.
  • the bone engagement member guide is configured to attach to an end of the intramedullary device, and the compression member is movable along the bone engagement member guide.
  • the bone engagement member which is also movable along the bone engagement member guide, includes at least two bone engagement points, where at least one bone engagement point is movable along an axis of the bone engagement member guide relative to at least one other bone engagement point and is configured to engage an end of the bone.
  • the bone engagement member guide defines an elongated void
  • the bone engagement member includes an internal part and an external part.
  • the internal part is configured to be movably retained within the bone engagement member guide
  • the external part is configured to extend outside of the bone engagement member guide and engage the end of the bone via at least one of the bone engagement points.
  • the compression member may be configured to apply force to the internal part of the bone engagement member
  • the external part of the bone engagement member may include one or more pressing elements configured to engage the end of the bone.
  • the external part of the bone engagement member may, in some cases, include at least two pressing elements, and at least one of the pressing elements may be shorter than the other pressing elements.
  • the bone engagement member of the intramedullary device assembly may, in some cases, be configured to attach to a drill guide.
  • the bone engagement member may define a keyway slot configured to permit alignment of the drill guide with respect to the intramedullary device assembly.
  • the intramedullary device assembly may include a breakaway stud connecting the intramedullary device and the bone engagement member guide.
  • the breakaway stud is configured to break away from the intramedullary device when a predetermined amount of force is applied to the breakaway stud. In some cases, this breakaway action may occur after the bone engagement member guide and the compression member have been detached from the intramedullary device.
  • the breakaway stud may also be configured to fit in a corresponding recess in the bone engagement member guide to limit rotation of the bone engagement member guide with respect to the intramedullary device.
  • the bone engagement member guide may further define a transverse locking hole
  • the breakaway stud may define a corresponding transverse locking hole, where the locking holes are configured to receive a locking mechanism such that the bone engagement member guide and the breakaway stud are locked together when the locking mechanism is in place.
  • the intramedullary device may define a nub having a circumferential lip configured to at least partially engage the bone engagement member guide.
  • the intramedullary device assembly includes an intramedullary device configured to be inserted into the medullary canal of the bone and fastened to the bone on either side of the defect, a bone engagement member guide, a compression member, and a bone engagement member.
  • the bone engagement member guide is configured to attach to the end of the intramedullary device, and the compression member is movable along the bone engagement member guide.
  • the bone engagement member of this embodiment includes a number of discrete pressing elements configured to engage an end of the bone.
  • the bone engagement member is movable along the bone engagement member guide, and application of force on the bone engagement member by the compression member in the direction of the bone advances the bone engagement member along the bone engagement member guide towards the intramedullary device and allows at least one of the pressing elements to engage the end of the bone.
  • the bone engagement member guide may include a tab configured to fit in a corresponding notch in the intramedullary device to limit rotation of the bone engagement member guide with respect to the device.
  • the intramedullary device assembly may include a breakaway stud connecting the intramedullary device and the bone engagement member guide. The breakaway stud is configured to break away from the intramedullary device when a predetermined amount of force is applied to the breakaway stud.
  • the break away action may occur after the bone engagement member guide and the compression member have been detached from the intramedullary device.
  • the bone engagement member guide may define a transverse locking hole
  • the breakaway stud may define a corresponding transverse locking hole, where the locking holes are configured to receive a locking mechanism such that the bone engagement member guide and the breakaway stud are locked together when the locking mechanism is in place.
  • the intramedullary device assembly may further define a nub having a circumferential lip configured to at least partially engage the bone engagement member guide.
  • a guide adapter for attaching a compression member and drill guide to an intramedullary device.
  • the guide adapter includes a bone engagement member guide and a bone engagement member movable along the bone engagement member guide.
  • One end of the bone engagement member guide includes a tab configured to engage the intramedullary device and limit rotation of the guide adapter with respect to the device, and another end of the bone engagement member guide is configured to support the compression member.
  • the bone engagement member includes at least two bone engagement points, where at least one of the bone engagement points is movable along an axis of the bone engagement member guide relative to at least one other bone engagement point and is configured to engage an end of a bone when the intramedullary device is installed.
  • the bone engagement member guide defines an elongated void
  • the bone engagement member includes an internal part and an external part.
  • the internal part is configured to be movably retained within the bone engagement member guide
  • the external part is configured to extend outside of the bone engagement member guide and engage the end of the bone via at least one of the bone engagement points.
  • the external part of the bone engagement member may include a number of pressing elements configured to engage the end of the bone, and at least one of the pressing elements may be shorter than the other pressing elements.
  • the bone engagement member guide may define a keyway slot configured to permit alignment of the drill guide with respect to the guide adapter when the drill guide is attached to the guide adapter.
  • one end of the guide adapter is configured to attach to a breakaway stud connecting the guide adapter to the intramedullary device.
  • a method of assembling an intramedullary device assembly for repairing a bone defect is provided.
  • a guide adapter is attached to a proximal end of an intramedullary device, where the guide adapter includes a bone engagement member guide and a bone engagement member movable along the bone engagement member guide.
  • the bone engagement member guide has a first end configured to attach to the proximal end of the intramedullary device, and the bone engagement member includes at least two bone engagement points. At least one bone engagement point is movable along an axis of the bone engagement member guide relative to at least one other bone engagement point and is configured to engage an end of the bone.
  • the method further includes attaching a compression member to a second end of the bone engagement member guide, where the compression member is movable along the bone engagement member guide.
  • a drill guide may also be attached to the guide adapter, where the drill guide is configured to allow drilling holes through the bone that are in alignment with corresponding holes defined by the intramedullary device.
  • attaching the guide adapter to the proximal end of the intramedullary device may include providing a breakaway stud at the proximal end of the intramedullary device and attaching the first end of the bone engagement member guide to the breakaway stud.
  • the guide adapter may be engaged with a lip formed on a nub defined by the proximal end of the intramedullary device.
  • a locking mechanism may also be inserted through corresponding transverse locking holes formed in the guide adapter and the breakaway stud.
  • a method of applying compression to repair a defect of a bone using an intramedullary device assembly including an intramedullary device, a bone engagement member guide attached to the intramedullary device, a bone engagement member movable along the bone engagement member guide, and a compression member is provided.
  • the intramedullary device of the intramedullary device assembly is inserted into the medullary canal of the bone, and the intramedullary device is fastened to a distal segment of the bone located on a distal side of the defect.
  • the compression member is advanced towards the bone and into engagement with the bone engagement member of the intramedullary device assembly.
  • the bone engagement member includes at least two bone engagement points, and at least one bone engagement point is movable along an axis of the bone engagement member guide relative to at least one other bone engagement point and is configured to engage the end of the bone.
  • the bone engagement member continues to advance with the compression member such that the distal segment of the bone is moved towards a proximal segment of the bone located on a proximal side of the defect.
  • the intramedullary device is fastened to the proximal segment to maintain compression of the distal and proximal segments of the bone.
  • the bone engagement member guide and the compression member may be detached from the inserted and fastened intramedullary device.
  • the method may include detaching the bone engagement member guide and the compression member from the intramedullary device by disconnecting the breakaway stud from the bone engagement member guide and subsequently separating the breakaway stud from the intramedullary device.
  • an intramedullary device and breakaway stud for attaching an intramedullary device to a bone engagement member guide are provided.
  • the intramedullary device is configured to be inserted into the medullary canal of a bone and fastened to the bone on either side of a defect.
  • the breakaway stud includes a proximal portion and a distal portion, where the proximal portion is configured to engage the bone engagement member guide and the distal portion is configured to engage the intramedullary device.
  • the distal portion includes a region of concentrated stress such that force applied to the breakaway stud is focused in the region of concentrated stress and causes the breakaway stud to break at or near the region of concentrated stress, thereby detaching the breakaway stud from the intramedullary device.
  • the proximal portion of the breakaway stud is domino- shaped, and the distal portion of the breakaway stud may be tapered.
  • the region of concentrated stress of the distal portion of the breakaway stud may be a region having a cross-sectional area that is smaller than other cross-sectional areas of the breakaway stud.
  • FIG. IA is an expanded perspective view of an intramedullary device assembly according to one embodiment
  • FIG. IB is an illustration of an intramedullary device with chamfered hole openings according to one embodiment
  • FIG. 2A is an illustration of an intramedullary device assembly installed in an ulna according to one embodiment
  • FIG. 2B shows engagement of a bone engagement member having pressing elements of equal length with a bone surface according to one embodiment
  • FIG. 2C shows engagement of a bone engagement member having pressing elements of unequal length with a bone surface according to another embodiment
  • FIG. 3 is a side view of a guide adapter with pressing elements according to one embodiment
  • FIG. 4 is an expanded side view of a bone engagement member guide including multiple components according to one embodiment
  • FIG. 5 A is a side view of a guide adapter and compression member according to one embodiment
  • FIG. 5B is a perspective view of the bone engagement member according to the embodiment of FIG. 5 A;
  • FIG. 6 A is a partial side view of an installed intramedullary device assembly achieving compression according to one embodiment
  • FIG. 6B is a partial side view of an installed intramedullary device of FIG. 6A after desired compression has been achieved and the guide adapter and compression member have been detached;
  • FIG. 7A is a perspective view of an intramedullary device assembly with attached drill guide according to one embodiment
  • FIG. 7B is a close-up perspective view of a connecting section of the drill guide of FIG. 7A;
  • FIG. 7C is a perspective view of the drill guide with a cannula adapted to be used as a drill depth gauge
  • FIG. 8 is an expanded perspective view of an intramedullary device assembly including a breakaway stud according to one embodiment
  • FIG. 9A is a close-up perspective view of the breakaway stud of FIG. 8;
  • FIG. 9B is a side plan view of the breakaway stud of FIG. 9 A;
  • FIG. 9C is a side plan view of the breakaway stud and nub within the guide adapter;
  • FIG. 1OA is a perspective view of the intramedullary device and guide adapter showing the tab of the guide adapter according to one embodiment
  • FIG. 1 OB is a perspective view showing the intramedullary device, breakaway stud, and guide adapter of FIG. 1 OA in an assembled configuration.
  • Embodiments of the present invention generally relate to an intramedullary device assembly for repairing fractures, osteotomies, and other defects of a long bone or periarticular bone.
  • the specification and accompanying figures will refer to bone fractures, although it is to be understood that any type of bone repair, including the repair of fractures, osteotomies, and other bone defects, and combinations thereof, may be accomplished using embodiments of the device described herein.
  • the intramedullary device assembly includes a device that is configured to be inserted into the medullary canal of the fractured bone.
  • a guide adapter attaches to the end of the intramedullary device and includes a movable bone engagement member configured such that a compression member attached to the guide adapter at an opposite end from the device can push the bone engagement member to engage the end of the bone.
  • proximal and distal refer to locations of the bone and assembly relative to the insertion site of the assembly after it has been inserted into the bone.
  • proximal side of the fracture refers to a segment of bone closer to the site at which the intramedullary device assembly was inserted;
  • distal side of the fracture refers to a segment of bone farther from the insertion site, and so on.
  • proximal and distal will coincide with those terms as used to describe the human body.
  • ankle applications for example, the terms will be reversed.
  • the compression member may be pre-adjusted such that the bone engagement member may be pushed against the proximal fragment as the intramedullary device is advanced into the medullary canal, as described below. In this way, at least partial compression at the fracture site may be provided without changing the position of the intramedullary device within the proximal fragment. Also in this way, the alignment of the bone segments may be provisionally held by the bone engagement member until more definitive fasteners are placed.
  • an intramedullary device assembly 10 according to one embodiment is shown in an expanded view.
  • the assembly 10 includes an intramedullary device 12, a guide adapter 14, and a compression member 16 that may be attached end-to-end to treat a fracture, as described below.
  • the intramedullary device 12 is configured (i.e., shaped and sized) to be inserted into the medullary canal of a bone and fastened to the bone on either side of the fracture.
  • the particular configuration of the intramedullary device 12 may vary depending on the type and size of the bone to be treated.
  • an intramedullary device 12 to be used for fixing a fracture of an adult femur may have different dimensions and may be shaped differently than a device 12 to be used for fixing a fracture of a child's radius.
  • the device 12 may be made of any absorbable or non-absorbable material that is compatible for use inside the human body, such as titanium, stainless steel, cobalt chrome, plastic, carbon fiber, or polymer.
  • the intramedullary device 12 is configured for use in an adult ulna via insertion through the olecranon.
  • the intramedullary device 12 and assembly 10 may be used in various other locations in the human body, such as for repairing a fracture of the lateral malleolus (distal fibula) at the ankle.
  • the intramedullary device 12 of Fig. IA is tapered, with the proximal end (i.e., the end closest to the olecranon when installed) having a slightly larger diameter than the distal end (i.e., the end farthest from the olecranon when installed).
  • the intramedullary device may be tapered in the reversed manner or remain uniform in diameter throughout its length. Its axis may be straight, as shown in Fig. IA, or curved. An ulna 18 and an olecranon 20 are illustrated in Fig. 2A, which shows an installed assembly 10 according to one embodiment.
  • the intramedullary device 12 may include a number of holes 22 configured to receive fasteners for fastening segments of bone to the intramedullary device 12.
  • the holes 22 may be located towards the distal end of the intramedullary device 12, for example to fasten a bone segment that is on a distal side of the fracture to the intramedullary device 12, whereas one or more other holes 22 may be located towards the proximal end of the intramedullary device 12, for fastening another bone segment that is on a proximal side of the fracture, as discussed below.
  • the holes 22 may be configured to receive various types of fasteners, such as pins, bolts, pegs, screws, and locking screws, among others.
  • the holes 22 may be internally threaded to receive corresponding externally threaded fasteners.
  • the holes 22 may have a chamfered opening 23 on the side configured to receive a corresponding fastener which may aid insertion of the fastener by providing a larger opening to accept and guide the fastener.
  • the guide adapter 14 of the assembly 10 includes a bone engagement member guide 24 and a bone engagement member 26, shown assembled according to one embodiment in Fig. 3.
  • the bone engagement member guide 24 is configured to attach to an end of the intramedullary device 12, namely at the proximal end of the device 12, and to retain at least part of the bone engagement member 26 within the bone engagement member guide 24.
  • the bone engagement member 26 includes an internal part 28 that is configured to be movably retained within the bone engagement member guide 24 and an external part 30 that is configured to extend outside of the bone engagement member guide 24 and engage the end of the bone, as described below.
  • the guide adapter bone engagement member guide 24 defines an elongated void 32, such as within a cannulated portion of the bone engagement member guide, to allow the bone engagement member 26 to move along the bone engagement member guide 24.
  • the bone engagement member 26 of the guide adapter 14 is configured to engage the end of the bone into which the intramedullary device 12 is inserted, as illustrated in Figs. 2A and 6A. It is to be understood that the bone engagement member 26 may engage directly against the bone itself, soft tissue connected to the bone, or any other material found on the surface of the bone.
  • the bone engagement member includes at least two bone engagement points configured to engage the end of the bone.
  • the bone engagement points comprise the ends of the pressing elements 40, which are illustrated as three prongs, and which extend from the internal part 28 of the bone engagement member 26 towards the end of the bone.
  • the bone engagement points may be points on a continuous surface, such as two or more points on a single bone engaging element.
  • the bone engagement member 26 could comprise a flat ring or horseshoe-shaped pad depending from the internal part 28, and at least two separate geometrical points on this pad would be movable relative to each other in an axial direction when the bone engagement member tilts relative to the bone engagement member guide 24.
  • the bone engagement points is permitted to move axially relative to at least one other bone engagement point such that it can more easily and securely engage the bone.
  • the bone engagement member 26 may be tiltable with respect to an axis X of the bone engagement member guide 24, such that the bone engagement member 26 may tilt in any direction in order to engage a bone surface that may not be perpendicular to the Jt-axis, as indicated by the curved arrows in Fig. 3. An example of this is illustrated in Fig. 6A.
  • the bone engagement points may be defined on structures that are configured to bend, rotate and/or telescope (with or without tilting) in order to engage the end of the bone in a desirable orientation so that the compression forces applied may be more balanced.
  • the bone engagement member guide 24 may include more than one part that fit together or are otherwise connected to form the bone engagement member guide 24 around the bone engagement member (not shown).
  • the bone engagement member guide 24 may include a base portion 34 and an upper portion 36 that are welded together or otherwise fixedly attached after the bone engagement member 26 (shown in Fig. 3) or a portion thereof is placed within the base portion 34.
  • the base portion 34 may include one or more slots 38 through which the external part 30 of the bone engagement member 26 is configured to pass through.
  • three slots 38 are defined in the base member 34, and the external part 30 of the bone engagement member 26 includes three pressing elements 40 that are configured to engage the end of the bone.
  • At least one of these pressing elements 40 may be shorter than the other pressing elements in order to enhance the strength or stability of the engagement between the pressing elements and the end of the bone.
  • differences in the length of the pressing elements may allow the pressing elements to conform to the angled surface of the bone while limiting the extent to which the bone engagement member must tilt to engage the bone.
  • the angle of the internal part 28 of the bone engagement member 26 may remain closer to 90° with respect to the AT-axis, providing for a more secure engagement with the bone. This is illustrated in Figs. 2B and 2C, where the angle ⁇ (corresponding to pressing elements of equal length) is greater than the angle ⁇ (corresponding to pressing elements of unequal length).
  • the external part 30 may be configured differently.
  • the base portion 34 of the bone engagement member guide 24 may further include grooves 35 that provide a visual reference to a surgeon of how far the bone engagement member 26 has advanced towards the bone.
  • the grooves 35 may be equidistantly spaced at a certain interval, such as 1 mm apart. In this case, advancement of the bone engagement member 26 past 3 grooves would indicate that the bone engagement member 26 has advanced 3 mm.
  • the compression member 16 of the assembly 10 is configured to attach to an end of the bone engagement member guide 24, opposite the end of the bone engagement member guide 24 that attaches to the intramedullary device 12.
  • the compression member 16 includes a pushing member 44, which may be integral to the compression member 16, as shown in Fig. IA, or may be formed separately and subsequently attached to the compression member 16, for example via a welded or threaded connection.
  • the compression member 16 is movable along the bone engagement member guide 24 and is configured to move the bone engagement member 26 into engagement with the end of the bone (e.g., via the pushing member 44).
  • Fig. 5 A shows a close-up view of the guide adapter 14 with the compression member 16 attached according to the embodiment illustrated in Fig. IA.
  • the upper portion 36 of the bone engagement member guide 24 may include an internally threaded region 46
  • the compression member 16 may include a corresponding externally threaded region 48 that is configured to mate with the internal threads 46 of the bone engagement member guide 24.
  • rotation of the compression member 16 such as by turning a handle 50 as indicated by the arrow, would serve to advance the compression member 16 and pushing member 44 farther into the bone engagement member guide 24, towards the bone engagement member 26.
  • the handle 50 may have various configurations. For example, the handle 50 depicted in Fig.
  • IA has a "T” configuration
  • handle 50 depicted in Fig. 7A has a knob configuration
  • the pushing member 44 may be pushed with or without a compressive member 16 manually or by electronic motor through the bone engagement member guide 24 toward the bone engagement member 26.
  • FIG. 6A shows continued application of force by the pushing member 44 on the bone engagement member 26, for example, by continued rotation of the handle 50 after engagement of the bone engagement member 26 with the pushing member 44 and the bone, would serve to advance the bone engagement member 26 farther along the bone engagement member guide 24 in the direction of the intramedullary device 12.
  • the intramedullary device 12 along with any attached bone segments, would be moved in the opposite direction (i.e., towards the compression member 16), thereby achieving compression as shown in Fig. 6A.
  • the compression member 16 e.g., via the pushing member 44
  • Fig. 5B shows the bone engagement member of Fig. 5A as it appears without the bone engagement member guide 24.
  • the guide adapter 14 of the intramedullary device assembly 10 may be configured to attach to a drill guide 52, as illustrated in Fig. 7A.
  • the drill guide 52 may be configured in various ways, depending on the configuration of the intramedullary device 12, the type of drill used (not shown), the doctor's preference, aesthetic appeal, durability and radiolucency of the materials, and other considerations.
  • the drill guide 52 is formed of radiolucent plastic material.
  • the drill guide 52 may include cannulas 54 configured to guide the drill bit or other instruments used to secure fasteners to the bone in which the intramedullary device assembly 10 is installed.
  • the drill guide 52 may surround the patient's elbow and forearm once the assembly 10 is installed, and the drill bit may be inserted through a cannula 54 in order to maintain the angle at which the drill bit approaches the bone to facilitate proper drilling.
  • the cannula 54 may act as a soft-tissue protector as it buries itself in the soft tissue (e.g., of the forearm) through minimally invasive puncture incisions and rests against the bone. This allows the drill bit to pass through and engage the bone without damaging the surrounding soft tissue structures.
  • Each cannula 54 may be movable between guide holes 56 at various locations defined by the drill guide 52.
  • the guide holes 56 may be configured to be aligned with the holes 22 of the intramedullary device 12 (Fig. IA), such that positioning the cannula 54 at a guide hole 56 facilitates the drilling of a hole through the bone that is aligned with a device hole 22, and a fastener may then be inserted to affix the drilled bone to the device 12.
  • the drill guide cannulas 54 may further be configured to indicate the depth of the drill bit during the drilling operation by using depth indicating markings 57 on the cannula 54 as shown in Fig. 7C and possibly using a drill bit that is configured with depth markings that may be read at the entrance to the cannula 54.
  • the drill guide 52 may be attached to the guide adapter 14 in many ways.
  • the drill guide 52 may have a circular void in the connecting section 53 (shown in Fig. 7A) that is configured to slide over a corresponding part of the upper portion 36 of the bone engagement member guide 24 (shown in Fig. 4).
  • a hex nut 58 or other type of end fastener may then be attached to the end of the upper portion 36, such as via external threads 59 on the upper portion 36 or via welding, to hold the drill guide 52 in place.
  • the drill guide 52 and the guide adaptor 14 may be fabricated from single piece of material so that the drill guide 52 and guide adaptor 14 are monolithic, rather than separately connected parts.
  • the bone engagement member guide 24 may define a keyway slot 60 (Fig. 4), for example in the upper portion 36, that is configured to permit alignment of the drill guide with respect to the bone engagement member guide 24 and the assembly 10 in general.
  • the drill guide 52 would have a corresponding extension 62 formed in the void of the connecting section 53 (rather than a perfectly circular void for sliding onto the upper portion 36), as shown in Fig. 7B, that is configured to fit into the keyway slot 60 such that the drill guide 52 will only be received by the upper portion 36 in the proper orientation (i.e., with the extension 62 aligned to fit into the keyway slot 60).
  • a separate adapter key 63 in the form of a rectangular bar, as shown in Figs.
  • IA and 8 may be provided to prevent rotation of the guide adapter 14 relative to the drill guide 52.
  • a rectangular cross-section groove or slot that is aligned with the axis of the guide adapter 14 is milled in the outside surface of upper portion of the guide adapter 14.
  • a corresponding slot is milled or broached into the drill guide 52 to be affixed to the guide adapter 14.
  • the adapter key 63 may then be put into the slot of the guide adapter 14 such that is protrudes from the surface, as shown in the figures, and is able to engage the corresponding slot in the drill guide 52, thereby preventing rotation of the guide adapter 14 relative to the drill guide 52.
  • the drill guide 52 may include an external rotation guide 86 to provide a surgeon with a way to determine whether the intramedullary device 12 is being inserted into the medullary canal in the proper rotational orientation. If the device 12 is not at the proper rotation, some of the fasteners may be placed in suboptimal (or even deleterious) positions with respect to certain fracture types.
  • the external rotation guide 86 may, for example, have an "X" configuration such that it may be used on different bones in the body. For instance, installing the intramedullary device 12 on a right elbow may require the surgeon to use one of the lines of the "X" for alignment, whereas installing the intramedullary device 12 on a left elbow may require the surgeon to use the other line.
  • the cross-members of the "X" may be of square or rectangular cross section allowing an identifier such as "right” or “left” to be printed or etched onto each of the cross-members.
  • the external rotation guide 86 may be removable (e.g., if the surgeon prefers other methods of confirming rotational alignment), and the position of the external rotation guide 86 may be adjustable such that it may be raised or lowered to correspond to the humeral epicondylar axis of the particular patient.
  • the guide adapter 14 may also include a tab 64 or other protrusion configured to engage the intramedullary device 12 to limit rotation of the guide adapter 14 with respect to the intramedullary device 12.
  • the tab 64 may be configured to fit in a corresponding notch 65 in the attachment end of the intramedullary device 12 such that the guide adapter 14 and the intramedullary device 12 may only be attached when the tab 64 is aligned with the corresponding notch 65, and, once attached, torsion and bending forces across the junction may be controlled.
  • the intramedullary device 12 may include a tab or other protrusion configured to engage a corresponding notch in the guide adapter 14 to limit rotation of the guide adapter 14 with respect to the intramedullary device 12 and to control torsion and bending forces across the junction.
  • the intramedullary device assembly 10 includes a breakaway stud 66 connecting the intramedullary device 12 and the guide adapter 14.
  • the breakaway stud 66 is configured to break away from the intramedullary device when a predetermined amount of force is applied to the breakaway stud 66.
  • the breakaway stud 66 may include a proximal portion 68 and a distal portion 70.
  • the proximal portion 68 is configured to engage the bone engagement member guide such that the bone engagement member guide is rotationally fixed with respect to the breakaway stud 66.
  • the proximal portion 68 may have a slab-like or domino shape, as seen in Fig. 9A, that is configured to fit into a corresponding recess in the guide adapter 14 such that rotation between the guide adapter 14 and the breakaway stud 66 is controlled.
  • the proximal portion 68 in some cases defines a ridge that fits into a slot formed in the recess of the guide adapter 14 or is otherwise configured such that the breakaway stud 66 can only be received in the recess in a certain orientation.
  • the distal portion 70 is configured to engage the intramedullary device and includes a region of concentrated stress 72 that allows the force applied to the breakaway stud 66 to be focused in the region of concentrated stress 72 and causes the breakaway stud 66 to break at or near the region of concentrated stress 72.
  • the distal portion 70 may be configured in various ways. For example, as shown in Fig. 9B, the distal portion 70 may be conically-shaped and may be tapered. Thus, in the embodiment of Fig. 9B, the region of concentrated stress 72 may be the region where the cross-sectional area of the tapered portion 70 is smallest. Alternatively, the region of concentrated stress 72 may include a "shark-bite" or other type of reduction in cross-section.
  • the guide adapter 14 and compression member 16 may be detached from the rest of the assembly.
  • the breakaway stud 66 may then be removed by applying a predetermined force to the breakaway stud 66 leaving the intramedullary device 12 installed in the bone to facilitate healing and at the same time allowing the patient to use the affected joint and bone to the extent possible.
  • the breakaway stud 66 may be broken away before the guide adapter 14 is removed from the assembly.
  • the region of concentrated stress 72 may include an undercut in the distal portion 70 where the breakaway stud 66 attaches to the intramedullary device 12 such that upon detachment (i.e., breaking of the breakaway stud 66), any residual portion of the stud 66 that remains attached to the intramedullary device 12 is recessed into the device 12. In this way, the residual stud is less palpable to the patient and the potential for soft tissue irritation is reduced.
  • the intramedullary assembly 10 need not, however, include a breakaway stud 66 to allow detachment of the guide adapter 14 and the compression member 16 from the intramedullary device 12.
  • the guide adapter 14 and the compression member 16 may detach in other ways, such as via a screw connection that is unscrewed once the installation is complete.
  • the proximal end of the intramedullary device 12 may define a short stump or nub 13 for attaching the breakaway stud 66, as shown in Figs. 8 and 9B.
  • the nub 13 may have a circumferential lip 15 that fits partially into the bone engagement member guide of the guide adapter 14 so as to offset some of the bending forces that the intramedullary device 12 may experience during installation in the bone.
  • the lip 15 may allow for the intramedullary device 12 to be manipulated after installation, for example to facilitate removal of the intramedullary device 12 from the bone if removal becomes necessary or desirable.
  • the guide adapter 14 in order to break the breakaway stud 66 to detach the intramedullary device 12 from the rest of the assembly, the guide adapter 14 must be disengaged from the lip 15 before force can be applied to the region of concentrated stress 72.
  • the guide adapter 14 may include a ridge 21 around the circumference, or a similar indicator, to indicate the location of the end of the nub 13 within the guide adapter 14 as shown in Fig. 9C. This ridge or marking would serve to indicate the depth to which the intramedullary device 12 must be inserted to prevent the nub 13 from protruding from the end of the bone.
  • the bone engagement member guide 24 of the guide adapter 14 may define a transverse locking hole 74, and the breakaway stud 66 may define a corresponding transverse locking hole 76, as shown in Fig. 9A.
  • the respective transverse locking holes 74, 76 may be aligned and thus configured to receive a locking mechanism 78, such as the pin illustrated,, that serves to lock the guide adapter 14 and the breakaway stud 66 to each other when the locking mechanism 78 is in place.
  • installation of the locking mechanism 78 functions to hold the intramedullary device 12 against the guide adapter 14 and to maintain rotational stability at the junction during installation of the assembly in the bone.
  • a catch 79 may be provided on the connecting section 53 of the drill guide 52 to hold the mechanism 78 in place during manipulation of the assembly 10, as illustrated in Fig. 7A.
  • the locking mechanism 78 may be removed so as to allow the intramedullary device to disengage from the guide adapter (i.e., to allow the lip 15 of the nub 13 to disengage from the bone engagement member guide), as previously discussed.
  • bending forces either along the axis or laterally thereto, and/or axial loads may be applied to the assembly to break the breakaway stud 66 at the region of concentrated stress 72 (Fig. 9B) and detach the intramedullary device 12 from the rest of the assembly.
  • a method for assembling an intramedullary device assembly for repairing a defect (or defects) of a bone is provided.
  • an intramedullary device 12 configured to be inserted into a medullary canal of a bone is provided.
  • the intramedullary device 12 may have various configurations, depending on the location and type of bone as well as other considerations.
  • the medullary canal of the bone may, in some cases, be prepared beforehand for receiving the intramedullary device 12 using tools and methods known by those skilled in the art, such as by drilling out the medullary canal so that the dimensions of the medullary canal correspond to the dimensions of the intramedullary device 12.
  • the intramedullary device 12 may then be inserted into the prepared medullary canal of the bone.
  • the intramedullary device 12 may be inserted into the medullary canal of a fractured ulna 18 through the metaphyseal end of ulna, or the olecranon 20.
  • the intramedullary device 12 may be inserted into the medullary canal of a fractured fibula through the metaphyseal end of the fibula, or the lateral malleolus.
  • the intramedullary device may also be configured so that it cuts its own path into the bone with or without the assistance of accessory tools.
  • the guide adapter 14 is attached to a proximal end of the intramedullary device 12, either before or after insertion of the intramedullary device 12 into the medullary canal.
  • the guide adapter 14 includes a bone engagement member guide 24 having a first end configured to attach to the proximal end of the intramedullary device 12 and a bone engagement member 26 that is movable along the bone engagement member guide 24 and includes at least two bone engagement points. At least one bone engagement point is movable along an axis of the bone engagement member guide 24 relative to at least one other bone engagement point and is configured to engage an end of the bone.
  • the bone engagement member guide 24 may be tiltable with respect to an axis X of the bone engagement member guide 24, as shown in Figs. 2 A, 2B, and 2C, or one or more of the bone engagement points may be defined on a structure, such as a discrete pressing element, that can bend, rotate, or telescope to engage the bone.
  • the bone engagement member guide 24 may be made up of one or more components.
  • the bone engagement member 26 of the guide adapter 14 is configured to engage the end of a bone.
  • the bone engagement member 26 includes multiple pressing elements 40 configured to engage the surface of the end of the bone (as illustrated in Figs. 2A and 6A).
  • a compression member 16 which is movable along the bone engagement member guide 24, is attached to the second end of the bone engagement member guide 24 (for example, as shown in Fig. 5A).
  • a drill guide 52 may also be attached to the guide adapter 14, for example, as previously described with reference to Figs. 4 and 7A.
  • the drill guide 52 may be configured to allow the drilling of holes through the bone (i.e., through the patient's soft tissues and into the bone) such that the drilled holes are in alignment with corresponding holes defined by the intramedullary device 12.
  • fasteners such as screws, pegs, bolts, pins or other fasteners may be inserted through the holes in the bone and received by the corresponding holes in the intramedullary device to hold the bone to the intramedullary device in those locations.
  • fasteners such as screws, pegs, bolts, pins or other fasteners may be inserted through the holes in the bone and received by the corresponding holes in the intramedullary device to hold the bone to the intramedullary device in those locations.
  • a breakaway stud 66 may be used to attach the guide adapter 14 to the proximal end of the intramedullary device 12.
  • one end of the breakaway stud 66 may be attached to the proximal end of the intramedullary device 12, and the other end of the breakaway stud 66 may be attached to the first end of the bone engagement member guide 24.
  • a locking mechanism 78 may be used to hold the breakaway stud 66 and the guide adapter 14 together via transverse locking holes 74, 76, and a lip 15 of the intramedullary device 12 may engage the guide adapter 14 for additional support, as shown in Fig. 1OB.
  • the intramedullary device assembly 10 is assembled and installed in the medullary canal of the affected bone, regardless of the order of the steps, compression may be applied to bring the bone segments on either side of the fracture together, thereby promoting the healing of the bone.
  • the intramedullary device is inserted into a medullary canal of the bone, for example, as previously described.
  • the intramedullary device 12 is fastened to a distal segment 80 of the bone (a segment located on the distal side of the bone defect relative to the intramedullary device assembly).
  • one or more locking screws 82 may be inserted through intramedullary device holes 22 (shown in Figs. IA and 8) to hold the distal segment 80 to the intramedullary device 12.
  • Compression may then be applied by advancing the compression member 16 towards the intramedullary device and bone (illustrated in Fig. 5A and indicated by the downward arrow) and into engagement with the bone engagement member 26.
  • the handle 50 of the compression member 16 may be rotated to advance the pushing member 44 into engagement with the bone engagement member 26.
  • the bone engagement member 26 advances towards the bone, engages the end of the bone, and continues to advance along the bone engagement member guide towards the intramedullary device 12, as illustrated in Fig. 6A, such that the distal segment 80 is moved towards the proximal segment 84 of the bone (i.e., the segment of bone located on the proximal side of the fracture relative to the intramedullary device assembly).
  • the relative movement of the compression member 16, the bone engagement member 26, the bone engagement member guide 24, the intramedullary device 12, and the distal segment 80 are shown in Fig. 6A with arrows on the respective elements.
  • the intramedullary device 12 may be fastened to the proximal segment 84 to maintain compression of the distal and proximal segments 80, 84.
  • screws, pegs, bolts, pins or other fasteners 82 may be inserted into holes in the intramedullary device 12, bicortically and/or unicortically, to fasten the proximal segment 84 to the intramedullary device 12.
  • the holes in the distal and/or proximal portions of the intramedullary device 12 may have internal threads (or another type of capturing mechanism) that are configured to engage external threads (or a corresponding capturing mechanism) of the fasteners.
  • Figs. 6A and 6B show the screws 82 in this example placed transversely to the device 12 and parallel to the other screws 82, the screws 82 or other fasteners may have various orientations according to the configuration of the receiving holes in the intramedullary device 12 and other considerations to allow for proper fastening between the bone and the intramedullary device 12.
  • the proximal segment 84 may be provisionally fixed at intramedullary assembly before compression is applied at the fracture such that compression at the fracture site may be provided without changing the position of the intramedullary device within the proximal segment.
  • the compression member may be pre-adjusted such that the bone engagement member is set at a pre-determined point along the guide adapter.
  • the entire intramedullary guide assembly may then be pushed toward the distal segment 80, while providing the ability for the surgeon to manually control and adjust the path of advancement of the proximal bone segment 84 towards the distal bone segment 80 by slight rotational or lateral movements of the intramedullary guide assembly until a desired level of initial compression is achieved at the fracture site.
  • the position of the intramedullary device may be adjusted if necessary via the compression member. By pushing the two bone fragments together in this way, the intramedullary device assembly provisionally holds the fracture reduced until the distal screws are in place. If more compression is required, the compression member may be advanced farther along the bone engagement member guide (towards the bone). Once the appropriate amount of compression is achieved, the proximal screws may be put in place.
  • the guide adapter, compression member, and other attached accessories may not be needed once the desired amount of compression has been achieved and the intramedullary device 12 has been fastened to the distal and proximal segments 80, 84 of the bone.
  • the first end of the bone engagement member guide may be detached from the intramedullary device 12, for example by unthreading the bone engagement member guide from the intramedullary device 12.
  • the intramedullary device 12 may remain in the medullary canal of the bone, with the bone segments 80, 84 attached to facilitate stabilization of the defect and proper healing, and, at the same time, extraneous components of the assembly may be removed to provide a relatively unobstructed surface of the bone and allow the patient to use the affected part to the extent possible with greater comfort.
  • the guide adapter 14 and the compression member 16 may be detached from the inserted and fastened intramedullary device 12 by removing a locking mechanism before applying force to break the breakaway stud 66 (for example, at the region of concentrated stress 72).
  • a breakaway stud for example, at the region of concentrated stress 72.
  • the locking mechanism 78 may need to be removed from the holes 74, 76 so that the intramedullary device 12 may be disengaged from the guide adapter 14 (i.e., by disengaging the lip 15). Once disengaged, force may be applied to the assembly to break the breakaway stud 66 and separate the intramedullary device 12 from the rest of the assembly. Furthermore, if removal of the intramedullary device 12 from the bone is required at some later time, the lip 15 may be used to withdraw the intramedullary device 12 from the medullary canal, as previously discussed.

Abstract

An intramedullary device assembly (10) is provided for repairing defects of a bone. The intramedullary device assembly includes a device (12) that is configured to be inserted into the medullary canal of the bone. The assembly also includes a guide adapter (14) that attaches to the end of the device and includes a movable and adjustable bone engagement member (26). Also a compression member (16) may be attached to the guide adapter that pushes the bone engagement member into engagement with the bone. The bone engagement member defines at least two bone engagement points and wherein at least one bone engagement point is movable relative to at least one other bone engagement point in the direction of the bone. The compression member forces the bone engagement member in the direction of the bone along the bone' engagement member guide and the at least one bone engagement point is permitted to move relative to the other at least one bone engagement point so that both bone engagement points can engage the end of the bone as compression is applied to the bone. The guide adapter and compression member may then be detached from the intramedullary device. A breakaway stud may also be included to connect the guide adapter to the intramedullary device such that the application of force on the assembly may break the breakaway stud and detach the guide adapter and compression member from the installed intramedullary device.

Description

INTRAMEDULLARY DEVICE ASSEMBLY AND ASSOCIATED METHOD
FIELD OF THE INVENTION
The present invention relates to intramedullary devices for repairing bone defects and, more specifically, to intramedullary device assemblies for providing fixation, compression, and/or stabilization of the diaphysis or metaphysis of a long bone or periarticular bone.
BACKGROUND OF THE INVENTION
Intramedullary devices, such as nails, rods, or pins, are often used in the medical field to treat fractures of long bones, such as in the ulna and femur. These intramedullary devices also may be used to treat periarticular fractures, such as in the distal radius and proximal humerus. Such devices are typically designed to be inserted into the medullary canal of the fractured bone and generally are fastened to the bone segments on either side of the fracture to stabilize the bone and promote proper healing. In some cases, the bone segments on either side of a fracture are spaced apart and must be brought closer together at the fracture to promote healing. Devices have been proposed that provide compression to such bone fractures by fixing the intramedullary device to one bone segment and then moving the free bone segment towards the fixed bone segment by way of compression applied to the end of the free bone segment. The free bone segment is then secured to the intramedullary device and the fracture is allowed to heal. However, these devices may not engage the end of the free bone segment in a manner that takes into account the bone structure at the end of the bone segment or provide balanced compression.
The structure of some bones, such as the ulna and femur, include a relatively hard outer shell comprised of cortical bone, and a relatively softer portion within the shell comprised of cancellous bone. In certain portions of bone, such as periarticular areas, the cortical bone can become quite thin and brittle. Thus, care must be taken when applying a compressive force to the end of the bone not to fracture or damage the cortical bone. Applying the compressive force in an unbalanced fashion to the end of the bone can be damaging to the cortical bone and may not provide a balanced compressive force at the fracture site.
Thus, there remains a need for an intramedullary device assembly that is easy to install without the need for extensive surgical dissection, and provides appropriate and balanced compression of the bone to promote healing.
BRIEF SUMMARY OF THE INVENTION
The present invention generally relates to an intramedullary device assembly for applying and maintaining compression of a bone. Advantageously, in one embodiment, the intramedullary device assembly includes a bone engagement member that is movable along a bone engagement member guide and includes bone engagement points where at least one of the bone engagement points is movable along an axis of the bone engagement member guide relative to another bone engagement point. The bone engagement member may be advanced along the bone engagement member guide by a compression member of the assembly and, in one exemplary embodiment, the bone engagement member can tilt to engage the end of the bone. Thus, the intramedullary device assembly may be easily inserted into the medullary canal of the bone at a joint, such as at the olecranon or the ankle malleolus, and is configured to provide appropriate and balanced compression of the bone to promote healing.
In one embodiment, the intramedullary device assembly includes an intramedullary device, a bone engagement member guide, a compression member, and a bone engagement member. The intramedullary device is configured to be inserted into the medullary canal of the bone and fastened to the bone on either side of the defect. The bone engagement member guide is configured to attach to an end of the intramedullary device, and the compression member is movable along the bone engagement member guide. The bone engagement member, which is also movable along the bone engagement member guide, includes at least two bone engagement points, where at least one bone engagement point is movable along an axis of the bone engagement member guide relative to at least one other bone engagement point and is configured to engage an end of the bone. Thus, application of force on the bone engagement member by the compression member in the direction of the bone advances the bone engagement member along the bone engagement member guide such that the at least one bone engagement point of the bone engagement member is permitted to move relative to the other at least one bone engagement point so that both bone engagement points can securely engage the end of the bone.
In some embodiments, the bone engagement member guide defines an elongated void, and the bone engagement member includes an internal part and an external part. The internal part is configured to be movably retained within the bone engagement member guide, and the external part is configured to extend outside of the bone engagement member guide and engage the end of the bone via at least one of the bone engagement points. The compression member may be configured to apply force to the internal part of the bone engagement member, and the external part of the bone engagement member may include one or more pressing elements configured to engage the end of the bone. The external part of the bone engagement member may, in some cases, include at least two pressing elements, and at least one of the pressing elements may be shorter than the other pressing elements.
The bone engagement member of the intramedullary device assembly may, in some cases, be configured to attach to a drill guide. The bone engagement member may define a keyway slot configured to permit alignment of the drill guide with respect to the intramedullary device assembly. In some embodiments, the intramedullary device assembly may include a breakaway stud connecting the intramedullary device and the bone engagement member guide. The breakaway stud is configured to break away from the intramedullary device when a predetermined amount of force is applied to the breakaway stud. In some cases, this breakaway action may occur after the bone engagement member guide and the compression member have been detached from the intramedullary device. The breakaway stud may also be configured to fit in a corresponding recess in the bone engagement member guide to limit rotation of the bone engagement member guide with respect to the intramedullary device. The bone engagement member guide may further define a transverse locking hole, and the breakaway stud may define a corresponding transverse locking hole, where the locking holes are configured to receive a locking mechanism such that the bone engagement member guide and the breakaway stud are locked together when the locking mechanism is in place. Furthermore, the intramedullary device may define a nub having a circumferential lip configured to at least partially engage the bone engagement member guide.
In another embodiment, the intramedullary device assembly includes an intramedullary device configured to be inserted into the medullary canal of the bone and fastened to the bone on either side of the defect, a bone engagement member guide, a compression member, and a bone engagement member. The bone engagement member guide is configured to attach to the end of the intramedullary device, and the compression member is movable along the bone engagement member guide. The bone engagement member of this embodiment includes a number of discrete pressing elements configured to engage an end of the bone. The bone engagement member is movable along the bone engagement member guide, and application of force on the bone engagement member by the compression member in the direction of the bone advances the bone engagement member along the bone engagement member guide towards the intramedullary device and allows at least one of the pressing elements to engage the end of the bone. The bone engagement member guide may include a tab configured to fit in a corresponding notch in the intramedullary device to limit rotation of the bone engagement member guide with respect to the device. The intramedullary device assembly may include a breakaway stud connecting the intramedullary device and the bone engagement member guide. The breakaway stud is configured to break away from the intramedullary device when a predetermined amount of force is applied to the breakaway stud. In some cases, the break away action may occur after the bone engagement member guide and the compression member have been detached from the intramedullary device. The bone engagement member guide may define a transverse locking hole, and the breakaway stud may define a corresponding transverse locking hole, where the locking holes are configured to receive a locking mechanism such that the bone engagement member guide and the breakaway stud are locked together when the locking mechanism is in place. The intramedullary device assembly may further define a nub having a circumferential lip configured to at least partially engage the bone engagement member guide.
In some embodiments, a guide adapter for attaching a compression member and drill guide to an intramedullary device is provided. The guide adapter includes a bone engagement member guide and a bone engagement member movable along the bone engagement member guide. One end of the bone engagement member guide includes a tab configured to engage the intramedullary device and limit rotation of the guide adapter with respect to the device, and another end of the bone engagement member guide is configured to support the compression member. The bone engagement member includes at least two bone engagement points, where at least one of the bone engagement points is movable along an axis of the bone engagement member guide relative to at least one other bone engagement point and is configured to engage an end of a bone when the intramedullary device is installed.
In some cases, the bone engagement member guide defines an elongated void, and the bone engagement member includes an internal part and an external part. The internal part is configured to be movably retained within the bone engagement member guide, and the external part is configured to extend outside of the bone engagement member guide and engage the end of the bone via at least one of the bone engagement points. The external part of the bone engagement member may include a number of pressing elements configured to engage the end of the bone, and at least one of the pressing elements may be shorter than the other pressing elements. Furthermore, the bone engagement member guide may define a keyway slot configured to permit alignment of the drill guide with respect to the guide adapter when the drill guide is attached to the guide adapter. In some embodiments, one end of the guide adapter is configured to attach to a breakaway stud connecting the guide adapter to the intramedullary device.
In other embodiments, a method of assembling an intramedullary device assembly for repairing a bone defect is provided. A guide adapter is attached to a proximal end of an intramedullary device, where the guide adapter includes a bone engagement member guide and a bone engagement member movable along the bone engagement member guide. The bone engagement member guide has a first end configured to attach to the proximal end of the intramedullary device, and the bone engagement member includes at least two bone engagement points. At least one bone engagement point is movable along an axis of the bone engagement member guide relative to at least one other bone engagement point and is configured to engage an end of the bone. The method further includes attaching a compression member to a second end of the bone engagement member guide, where the compression member is movable along the bone engagement member guide.
A drill guide may also be attached to the guide adapter, where the drill guide is configured to allow drilling holes through the bone that are in alignment with corresponding holes defined by the intramedullary device. Furthermore, attaching the guide adapter to the proximal end of the intramedullary device may include providing a breakaway stud at the proximal end of the intramedullary device and attaching the first end of the bone engagement member guide to the breakaway stud. In some cases, the guide adapter may be engaged with a lip formed on a nub defined by the proximal end of the intramedullary device. A locking mechanism may also be inserted through corresponding transverse locking holes formed in the guide adapter and the breakaway stud.
In other embodiments, a method of applying compression to repair a defect of a bone using an intramedullary device assembly including an intramedullary device, a bone engagement member guide attached to the intramedullary device, a bone engagement member movable along the bone engagement member guide, and a compression member is provided. The intramedullary device of the intramedullary device assembly is inserted into the medullary canal of the bone, and the intramedullary device is fastened to a distal segment of the bone located on a distal side of the defect. The compression member is advanced towards the bone and into engagement with the bone engagement member of the intramedullary device assembly. The bone engagement member includes at least two bone engagement points, and at least one bone engagement point is movable along an axis of the bone engagement member guide relative to at least one other bone engagement point and is configured to engage the end of the bone. The bone engagement member continues to advance with the compression member such that the distal segment of the bone is moved towards a proximal segment of the bone located on a proximal side of the defect. Furthermore, the intramedullary device is fastened to the proximal segment to maintain compression of the distal and proximal segments of the bone.
In some cases, the bone engagement member guide and the compression member may be detached from the inserted and fastened intramedullary device. The method may include detaching the bone engagement member guide and the compression member from the intramedullary device by disconnecting the breakaway stud from the bone engagement member guide and subsequently separating the breakaway stud from the intramedullary device.
In other embodiments, an intramedullary device and breakaway stud for attaching an intramedullary device to a bone engagement member guide are provided. The intramedullary device is configured to be inserted into the medullary canal of a bone and fastened to the bone on either side of a defect. The breakaway stud includes a proximal portion and a distal portion, where the proximal portion is configured to engage the bone engagement member guide and the distal portion is configured to engage the intramedullary device. The distal portion includes a region of concentrated stress such that force applied to the breakaway stud is focused in the region of concentrated stress and causes the breakaway stud to break at or near the region of concentrated stress, thereby detaching the breakaway stud from the intramedullary device. In some cases, the proximal portion of the breakaway stud is domino- shaped, and the distal portion of the breakaway stud may be tapered. Furthermore, the region of concentrated stress of the distal portion of the breakaway stud may be a region having a cross-sectional area that is smaller than other cross-sectional areas of the breakaway stud.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) Having thus described the invention in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:
FIG. IA is an expanded perspective view of an intramedullary device assembly according to one embodiment; FIG. IB is an illustration of an intramedullary device with chamfered hole openings according to one embodiment;
FIG. 2A is an illustration of an intramedullary device assembly installed in an ulna according to one embodiment;
FIG. 2B shows engagement of a bone engagement member having pressing elements of equal length with a bone surface according to one embodiment;
FIG. 2C shows engagement of a bone engagement member having pressing elements of unequal length with a bone surface according to another embodiment;
FIG. 3 is a side view of a guide adapter with pressing elements according to one embodiment; FIG. 4 is an expanded side view of a bone engagement member guide including multiple components according to one embodiment;
FIG. 5 A is a side view of a guide adapter and compression member according to one embodiment;
FIG. 5B is a perspective view of the bone engagement member according to the embodiment of FIG. 5 A;
FIG. 6 A is a partial side view of an installed intramedullary device assembly achieving compression according to one embodiment;
FIG. 6B is a partial side view of an installed intramedullary device of FIG. 6A after desired compression has been achieved and the guide adapter and compression member have been detached;
FIG. 7A is a perspective view of an intramedullary device assembly with attached drill guide according to one embodiment; FIG. 7B is a close-up perspective view of a connecting section of the drill guide of FIG. 7A;
FIG. 7C is a perspective view of the drill guide with a cannula adapted to be used as a drill depth gauge; FIG. 8 is an expanded perspective view of an intramedullary device assembly including a breakaway stud according to one embodiment;
FIG. 9A is a close-up perspective view of the breakaway stud of FIG. 8; FIG. 9B is a side plan view of the breakaway stud of FIG. 9 A; FIG. 9C is a side plan view of the breakaway stud and nub within the guide adapter;
FIG. 1OA is a perspective view of the intramedullary device and guide adapter showing the tab of the guide adapter according to one embodiment; and
FIG. 1 OB is a perspective view showing the intramedullary device, breakaway stud, and guide adapter of FIG. 1 OA in an assembled configuration.
DETAILED DESCRIPTION OF THE DRAWINGS The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.
Embodiments of the present invention generally relate to an intramedullary device assembly for repairing fractures, osteotomies, and other defects of a long bone or periarticular bone. For ease of explanation, however, the specification and accompanying figures will refer to bone fractures, although it is to be understood that any type of bone repair, including the repair of fractures, osteotomies, and other bone defects, and combinations thereof, may be accomplished using embodiments of the device described herein. As described further below, the intramedullary device assembly includes a device that is configured to be inserted into the medullary canal of the fractured bone. A guide adapter attaches to the end of the intramedullary device and includes a movable bone engagement member configured such that a compression member attached to the guide adapter at an opposite end from the device can push the bone engagement member to engage the end of the bone. By fastening the installed intramedullary device to the bone segment on a distal side of the fracture and then applying compression via the compression member and bone engagement member, the fastened bone segment may be pushed towards the bone segment on the proximal side of the fracture. Once the desired compression is achieved, the proximal bone segment may be fastened to the intramedullary device, and the guide adapter and compression member may be detached from the device so that the patient may be able to use the affected joint to a greater extent during the healing process. In this regard, the terms "proximal" and "distal" refer to locations of the bone and assembly relative to the insertion site of the assembly after it has been inserted into the bone. In other words, the proximal side of the fracture refers to a segment of bone closer to the site at which the intramedullary device assembly was inserted; the distal side of the fracture refers to a segment of bone farther from the insertion site, and so on. Thus, for ulnar applications at the olecranon, the terms proximal and distal will coincide with those terms as used to describe the human body. However, for ankle applications, for example, the terms will be reversed. The compression member may be pre-adjusted such that the bone engagement member may be pushed against the proximal fragment as the intramedullary device is advanced into the medullary canal, as described below. In this way, at least partial compression at the fracture site may be provided without changing the position of the intramedullary device within the proximal fragment. Also in this way, the alignment of the bone segments may be provisionally held by the bone engagement member until more definitive fasteners are placed.
Referring to Fig. IA, an intramedullary device assembly 10 according to one embodiment is shown in an expanded view. The assembly 10 includes an intramedullary device 12, a guide adapter 14, and a compression member 16 that may be attached end-to-end to treat a fracture, as described below. The intramedullary device 12 is configured (i.e., shaped and sized) to be inserted into the medullary canal of a bone and fastened to the bone on either side of the fracture. Thus, the particular configuration of the intramedullary device 12 may vary depending on the type and size of the bone to be treated. For example, an intramedullary device 12 to be used for fixing a fracture of an adult femur may have different dimensions and may be shaped differently than a device 12 to be used for fixing a fracture of a child's radius. Furthermore, the device 12 may be made of any absorbable or non-absorbable material that is compatible for use inside the human body, such as titanium, stainless steel, cobalt chrome, plastic, carbon fiber, or polymer.
In the embodiment shown in Fig. IA, for example, the intramedullary device 12 is configured for use in an adult ulna via insertion through the olecranon. However, the intramedullary device 12 and assembly 10 may be used in various other locations in the human body, such as for repairing a fracture of the lateral malleolus (distal fibula) at the ankle. The intramedullary device 12 of Fig. IA is tapered, with the proximal end (i.e., the end closest to the olecranon when installed) having a slightly larger diameter than the distal end (i.e., the end farthest from the olecranon when installed). Also, the intramedullary device may be tapered in the reversed manner or remain uniform in diameter throughout its length. Its axis may be straight, as shown in Fig. IA, or curved. An ulna 18 and an olecranon 20 are illustrated in Fig. 2A, which shows an installed assembly 10 according to one embodiment. Referring again to Fig. IA, the intramedullary device 12 may include a number of holes 22 configured to receive fasteners for fastening segments of bone to the intramedullary device 12. One or more of the holes 22 may be located towards the distal end of the intramedullary device 12, for example to fasten a bone segment that is on a distal side of the fracture to the intramedullary device 12, whereas one or more other holes 22 may be located towards the proximal end of the intramedullary device 12, for fastening another bone segment that is on a proximal side of the fracture, as discussed below. Furthermore, the holes 22 may be configured to receive various types of fasteners, such as pins, bolts, pegs, screws, and locking screws, among others. In some cases, the holes 22 may be internally threaded to receive corresponding externally threaded fasteners. As shown in Fig. IB, the holes 22 may have a chamfered opening 23 on the side configured to receive a corresponding fastener which may aid insertion of the fastener by providing a larger opening to accept and guide the fastener.
The guide adapter 14 of the assembly 10 includes a bone engagement member guide 24 and a bone engagement member 26, shown assembled according to one embodiment in Fig. 3. The bone engagement member guide 24 is configured to attach to an end of the intramedullary device 12, namely at the proximal end of the device 12, and to retain at least part of the bone engagement member 26 within the bone engagement member guide 24. For example, in the embodiment shown in Fig. 3, the bone engagement member 26 includes an internal part 28 that is configured to be movably retained within the bone engagement member guide 24 and an external part 30 that is configured to extend outside of the bone engagement member guide 24 and engage the end of the bone, as described below. In some cases, the guide adapter bone engagement member guide 24 defines an elongated void 32, such as within a cannulated portion of the bone engagement member guide, to allow the bone engagement member 26 to move along the bone engagement member guide 24. The bone engagement member 26 of the guide adapter 14 is configured to engage the end of the bone into which the intramedullary device 12 is inserted, as illustrated in Figs. 2A and 6A. It is to be understood that the bone engagement member 26 may engage directly against the bone itself, soft tissue connected to the bone, or any other material found on the surface of the bone.
The bone engagement member includes at least two bone engagement points configured to engage the end of the bone. In Fig. 3, for example, the bone engagement points comprise the ends of the pressing elements 40, which are illustrated as three prongs, and which extend from the internal part 28 of the bone engagement member 26 towards the end of the bone. However, in other embodiments, the bone engagement points may be points on a continuous surface, such as two or more points on a single bone engaging element. For example, the bone engagement member 26 could comprise a flat ring or horseshoe-shaped pad depending from the internal part 28, and at least two separate geometrical points on this pad would be movable relative to each other in an axial direction when the bone engagement member tilts relative to the bone engagement member guide 24. In any case, at least one of the bone engagement points is permitted to move axially relative to at least one other bone engagement point such that it can more easily and securely engage the bone. As noted, the bone engagement member 26 may be tiltable with respect to an axis X of the bone engagement member guide 24, such that the bone engagement member 26 may tilt in any direction in order to engage a bone surface that may not be perpendicular to the Jt-axis, as indicated by the curved arrows in Fig. 3. An example of this is illustrated in Fig. 6A. In other embodiments, the bone engagement points may be defined on structures that are configured to bend, rotate and/or telescope (with or without tilting) in order to engage the end of the bone in a desirable orientation so that the compression forces applied may be more balanced.
Referring to Fig. 4, the bone engagement member guide 24 may include more than one part that fit together or are otherwise connected to form the bone engagement member guide 24 around the bone engagement member (not shown). For example, the bone engagement member guide 24 may include a base portion 34 and an upper portion 36 that are welded together or otherwise fixedly attached after the bone engagement member 26 (shown in Fig. 3) or a portion thereof is placed within the base portion 34. In this regard, the base portion 34 may include one or more slots 38 through which the external part 30 of the bone engagement member 26 is configured to pass through. In the embodiment illustrated in Fig. 3, for example, three slots 38 (one visible) are defined in the base member 34, and the external part 30 of the bone engagement member 26 includes three pressing elements 40 that are configured to engage the end of the bone. Furthermore, at least one of these pressing elements 40 may be shorter than the other pressing elements in order to enhance the strength or stability of the engagement between the pressing elements and the end of the bone. In other words, differences in the length of the pressing elements may allow the pressing elements to conform to the angled surface of the bone while limiting the extent to which the bone engagement member must tilt to engage the bone. Thus, the angle of the internal part 28 of the bone engagement member 26 may remain closer to 90° with respect to the AT-axis, providing for a more secure engagement with the bone. This is illustrated in Figs. 2B and 2C, where the angle α (corresponding to pressing elements of equal length) is greater than the angle β (corresponding to pressing elements of unequal length). In other embodiments, the external part 30 may be configured differently.
The base portion 34 of the bone engagement member guide 24 may further include grooves 35 that provide a visual reference to a surgeon of how far the bone engagement member 26 has advanced towards the bone. For example, the grooves 35 may be equidistantly spaced at a certain interval, such as 1 mm apart. In this case, advancement of the bone engagement member 26 past 3 grooves would indicate that the bone engagement member 26 has advanced 3 mm.
Referring again to Fig. IA, the compression member 16 of the assembly 10 is configured to attach to an end of the bone engagement member guide 24, opposite the end of the bone engagement member guide 24 that attaches to the intramedullary device 12. In some embodiments, the compression member 16 includes a pushing member 44, which may be integral to the compression member 16, as shown in Fig. IA, or may be formed separately and subsequently attached to the compression member 16, for example via a welded or threaded connection. Regardless, the compression member 16 is movable along the bone engagement member guide 24 and is configured to move the bone engagement member 26 into engagement with the end of the bone (e.g., via the pushing member 44).
For example, Fig. 5 A shows a close-up view of the guide adapter 14 with the compression member 16 attached according to the embodiment illustrated in Fig. IA. In this example, the upper portion 36 of the bone engagement member guide 24 may include an internally threaded region 46, and the compression member 16 may include a corresponding externally threaded region 48 that is configured to mate with the internal threads 46 of the bone engagement member guide 24. In this way, rotation of the compression member 16, such as by turning a handle 50 as indicated by the arrow, would serve to advance the compression member 16 and pushing member 44 farther into the bone engagement member guide 24, towards the bone engagement member 26. The handle 50 may have various configurations. For example, the handle 50 depicted in Fig. IA has a "T" configuration, whereas the handle 50 depicted in Fig. 7A has a knob configuration. Optionally, the pushing member 44 may be pushed with or without a compressive member 16 manually or by electronic motor through the bone engagement member guide 24 toward the bone engagement member 26. There may be a locking mechanism between the compressive member 16 and/or pushing member 44 and the bone engagement member guide 24 to maintain the position of the compression member 16 against the bone engagement member 26. In an installed assembly 10 (shown in Fig. 6A), continued application of force by the pushing member 44 on the bone engagement member 26, for example, by continued rotation of the handle 50 after engagement of the bone engagement member 26 with the pushing member 44 and the bone, would serve to advance the bone engagement member 26 farther along the bone engagement member guide 24 in the direction of the intramedullary device 12. As a result, the intramedullary device 12, along with any attached bone segments, would be moved in the opposite direction (i.e., towards the compression member 16), thereby achieving compression as shown in Fig. 6A. In some embodiments, such as the one illustrated in Fig. 5A, the compression member 16 (e.g., via the pushing member 44) is configured to apply force to the internal part 28 of the bone engagement member 26. Fig. 5B shows the bone engagement member of Fig. 5A as it appears without the bone engagement member guide 24.
The guide adapter 14 of the intramedullary device assembly 10 may be configured to attach to a drill guide 52, as illustrated in Fig. 7A. The drill guide 52 may be configured in various ways, depending on the configuration of the intramedullary device 12, the type of drill used (not shown), the doctor's preference, aesthetic appeal, durability and radiolucency of the materials, and other considerations. According to one embodiment, the drill guide 52 is formed of radiolucent plastic material. In general, the drill guide 52 may include cannulas 54 configured to guide the drill bit or other instruments used to secure fasteners to the bone in which the intramedullary device assembly 10 is installed. For example, in the treatment of a fractured ulna, the drill guide 52 may surround the patient's elbow and forearm once the assembly 10 is installed, and the drill bit may be inserted through a cannula 54 in order to maintain the angle at which the drill bit approaches the bone to facilitate proper drilling. Furthermore, the cannula 54 may act as a soft-tissue protector as it buries itself in the soft tissue (e.g., of the forearm) through minimally invasive puncture incisions and rests against the bone. This allows the drill bit to pass through and engage the bone without damaging the surrounding soft tissue structures. Each cannula 54 may be movable between guide holes 56 at various locations defined by the drill guide 52. In this regard, the guide holes 56 may be configured to be aligned with the holes 22 of the intramedullary device 12 (Fig. IA), such that positioning the cannula 54 at a guide hole 56 facilitates the drilling of a hole through the bone that is aligned with a device hole 22, and a fastener may then be inserted to affix the drilled bone to the device 12. The drill guide cannulas 54 may further be configured to indicate the depth of the drill bit during the drilling operation by using depth indicating markings 57 on the cannula 54 as shown in Fig. 7C and possibly using a drill bit that is configured with depth markings that may be read at the entrance to the cannula 54.
The drill guide 52 may be attached to the guide adapter 14 in many ways. For example, referring to Figs. 4, 7A, and 7B, the drill guide 52 may have a circular void in the connecting section 53 (shown in Fig. 7A) that is configured to slide over a corresponding part of the upper portion 36 of the bone engagement member guide 24 (shown in Fig. 4). A hex nut 58 or other type of end fastener may then be attached to the end of the upper portion 36, such as via external threads 59 on the upper portion 36 or via welding, to hold the drill guide 52 in place. Optionally, the drill guide 52 and the guide adaptor 14 may be fabricated from single piece of material so that the drill guide 52 and guide adaptor 14 are monolithic, rather than separately connected parts.
Furthermore, the bone engagement member guide 24 may define a keyway slot 60 (Fig. 4), for example in the upper portion 36, that is configured to permit alignment of the drill guide with respect to the bone engagement member guide 24 and the assembly 10 in general. In this case, the drill guide 52 would have a corresponding extension 62 formed in the void of the connecting section 53 (rather than a perfectly circular void for sliding onto the upper portion 36), as shown in Fig. 7B, that is configured to fit into the keyway slot 60 such that the drill guide 52 will only be received by the upper portion 36 in the proper orientation (i.e., with the extension 62 aligned to fit into the keyway slot 60). Alternatively, a separate adapter key 63 in the form of a rectangular bar, as shown in Figs. IA and 8, may be provided to prevent rotation of the guide adapter 14 relative to the drill guide 52. In this regard, a rectangular cross-section groove or slot that is aligned with the axis of the guide adapter 14 is milled in the outside surface of upper portion of the guide adapter 14. A corresponding slot is milled or broached into the drill guide 52 to be affixed to the guide adapter 14. The adapter key 63 may then be put into the slot of the guide adapter 14 such that is protrudes from the surface, as shown in the figures, and is able to engage the corresponding slot in the drill guide 52, thereby preventing rotation of the guide adapter 14 relative to the drill guide 52. In some cases, such as in the embodiment of Fig. 7A, the drill guide 52 may include an external rotation guide 86 to provide a surgeon with a way to determine whether the intramedullary device 12 is being inserted into the medullary canal in the proper rotational orientation. If the device 12 is not at the proper rotation, some of the fasteners may be placed in suboptimal (or even deleterious) positions with respect to certain fracture types. The external rotation guide 86 may, for example, have an "X" configuration such that it may be used on different bones in the body. For instance, installing the intramedullary device 12 on a right elbow may require the surgeon to use one of the lines of the "X" for alignment, whereas installing the intramedullary device 12 on a left elbow may require the surgeon to use the other line. The cross-members of the "X" may be of square or rectangular cross section allowing an identifier such as "right" or "left" to be printed or etched onto each of the cross-members. Once the intramedullary device 12 is inserted into the canal, prior to drilling for screws, the proper rotation may be confirmed by lining up the plane of the external rotation guide 86 with the axis between the humeral epicondyles (in this example). The axis in this case should be approximately 10° from the horizontal relative to the joint line of the ulnohumeral joint. If the device 12 is rotated inappropriately, the respective line of the "X" will appear tilted away from the axis of the epicondyles, warning the surgeon that the position of the device 12 needs readjustment prior to drilling. The external rotation guide 86 may be removable (e.g., if the surgeon prefers other methods of confirming rotational alignment), and the position of the external rotation guide 86 may be adjustable such that it may be raised or lowered to correspond to the humeral epicondylar axis of the particular patient. Referring to Figs. 3, 4, and 1OA, the guide adapter 14 may also include a tab 64 or other protrusion configured to engage the intramedullary device 12 to limit rotation of the guide adapter 14 with respect to the intramedullary device 12. In this regard, the tab 64 may be configured to fit in a corresponding notch 65 in the attachment end of the intramedullary device 12 such that the guide adapter 14 and the intramedullary device 12 may only be attached when the tab 64 is aligned with the corresponding notch 65, and, once attached, torsion and bending forces across the junction may be controlled. Optionally, the intramedullary device 12 may include a tab or other protrusion configured to engage a corresponding notch in the guide adapter 14 to limit rotation of the guide adapter 14 with respect to the intramedullary device 12 and to control torsion and bending forces across the junction.
In some embodiments, such as the one illustrated in Fig. 8, the intramedullary device assembly 10 includes a breakaway stud 66 connecting the intramedullary device 12 and the guide adapter 14. The breakaway stud 66 is configured to break away from the intramedullary device when a predetermined amount of force is applied to the breakaway stud 66. Referring to Figs. 9A and 9B, for example, the breakaway stud 66 may include a proximal portion 68 and a distal portion 70. The proximal portion 68 is configured to engage the bone engagement member guide such that the bone engagement member guide is rotationally fixed with respect to the breakaway stud 66. For example, the proximal portion 68 may have a slab-like or domino shape, as seen in Fig. 9A, that is configured to fit into a corresponding recess in the guide adapter 14 such that rotation between the guide adapter 14 and the breakaway stud 66 is controlled. The proximal portion 68 in some cases defines a ridge that fits into a slot formed in the recess of the guide adapter 14 or is otherwise configured such that the breakaway stud 66 can only be received in the recess in a certain orientation.
The distal portion 70 is configured to engage the intramedullary device and includes a region of concentrated stress 72 that allows the force applied to the breakaway stud 66 to be focused in the region of concentrated stress 72 and causes the breakaway stud 66 to break at or near the region of concentrated stress 72. The distal portion 70 may be configured in various ways. For example, as shown in Fig. 9B, the distal portion 70 may be conically-shaped and may be tapered. Thus, in the embodiment of Fig. 9B, the region of concentrated stress 72 may be the region where the cross-sectional area of the tapered portion 70 is smallest. Alternatively, the region of concentrated stress 72 may include a "shark-bite" or other type of reduction in cross-section. In this way, once the assembly 10 has been installed in the medullary canal of the fractured bone, compression of the fracture has been achieved, and the bone segments of the fracture have been fastened to the intramedullary device such that the fracture can heal, the guide adapter 14 and compression member 16 may be detached from the rest of the assembly. The breakaway stud 66 may then be removed by applying a predetermined force to the breakaway stud 66 leaving the intramedullary device 12 installed in the bone to facilitate healing and at the same time allowing the patient to use the affected joint and bone to the extent possible. In some embodiments, the breakaway stud 66 may be broken away before the guide adapter 14 is removed from the assembly. In some cases, the region of concentrated stress 72 may include an undercut in the distal portion 70 where the breakaway stud 66 attaches to the intramedullary device 12 such that upon detachment (i.e., breaking of the breakaway stud 66), any residual portion of the stud 66 that remains attached to the intramedullary device 12 is recessed into the device 12. In this way, the residual stud is less palpable to the patient and the potential for soft tissue irritation is reduced.
The intramedullary assembly 10 need not, however, include a breakaway stud 66 to allow detachment of the guide adapter 14 and the compression member 16 from the intramedullary device 12. The guide adapter 14 and the compression member 16 may detach in other ways, such as via a screw connection that is unscrewed once the installation is complete.
In some embodiments, the proximal end of the intramedullary device 12 may define a short stump or nub 13 for attaching the breakaway stud 66, as shown in Figs. 8 and 9B. The nub 13 may have a circumferential lip 15 that fits partially into the bone engagement member guide of the guide adapter 14 so as to offset some of the bending forces that the intramedullary device 12 may experience during installation in the bone. Furthermore, the lip 15 may allow for the intramedullary device 12 to be manipulated after installation, for example to facilitate removal of the intramedullary device 12 from the bone if removal becomes necessary or desirable. In this case, in order to break the breakaway stud 66 to detach the intramedullary device 12 from the rest of the assembly, the guide adapter 14 must be disengaged from the lip 15 before force can be applied to the region of concentrated stress 72. The guide adapter 14 may include a ridge 21 around the circumference, or a similar indicator, to indicate the location of the end of the nub 13 within the guide adapter 14 as shown in Fig. 9C. This ridge or marking would serve to indicate the depth to which the intramedullary device 12 must be inserted to prevent the nub 13 from protruding from the end of the bone. The bone engagement member guide 24 of the guide adapter 14 may define a transverse locking hole 74, and the breakaway stud 66 may define a corresponding transverse locking hole 76, as shown in Fig. 9A. When the guide adapter 14 and the breakaway stud 66 are assembled, the respective transverse locking holes 74, 76 may be aligned and thus configured to receive a locking mechanism 78, such as the pin illustrated,, that serves to lock the guide adapter 14 and the breakaway stud 66 to each other when the locking mechanism 78 is in place. Referring to Fig. 1OB, installation of the locking mechanism 78 functions to hold the intramedullary device 12 against the guide adapter 14 and to maintain rotational stability at the junction during installation of the assembly in the bone. A catch 79 may be provided on the connecting section 53 of the drill guide 52 to hold the mechanism 78 in place during manipulation of the assembly 10, as illustrated in Fig. 7A. Upon detaching the intramedullary device 12 from the guide adapter 14, the locking mechanism 78 may be removed so as to allow the intramedullary device to disengage from the guide adapter (i.e., to allow the lip 15 of the nub 13 to disengage from the bone engagement member guide), as previously discussed. At this point, bending forces, either along the axis or laterally thereto, and/or axial loads may be applied to the assembly to break the breakaway stud 66 at the region of concentrated stress 72 (Fig. 9B) and detach the intramedullary device 12 from the rest of the assembly. In other embodiments, a method for assembling an intramedullary device assembly for repairing a defect (or defects) of a bone is provided. Referring to Fig. IA, initially, an intramedullary device 12 configured to be inserted into a medullary canal of a bone is provided. As previously described, the intramedullary device 12 may have various configurations, depending on the location and type of bone as well as other considerations. The medullary canal of the bone may, in some cases, be prepared beforehand for receiving the intramedullary device 12 using tools and methods known by those skilled in the art, such as by drilling out the medullary canal so that the dimensions of the medullary canal correspond to the dimensions of the intramedullary device 12. The intramedullary device 12 may then be inserted into the prepared medullary canal of the bone. For example, referring to Fig. 2 A, the intramedullary device 12 may be inserted into the medullary canal of a fractured ulna 18 through the metaphyseal end of ulna, or the olecranon 20. As another example, the intramedullary device 12 may be inserted into the medullary canal of a fractured fibula through the metaphyseal end of the fibula, or the lateral malleolus. The intramedullary device may also be configured so that it cuts its own path into the bone with or without the assistance of accessory tools.
Referring again to Fig. IA, the guide adapter 14 is attached to a proximal end of the intramedullary device 12, either before or after insertion of the intramedullary device 12 into the medullary canal. As previously described, the guide adapter 14 includes a bone engagement member guide 24 having a first end configured to attach to the proximal end of the intramedullary device 12 and a bone engagement member 26 that is movable along the bone engagement member guide 24 and includes at least two bone engagement points. At least one bone engagement point is movable along an axis of the bone engagement member guide 24 relative to at least one other bone engagement point and is configured to engage an end of the bone. For example, the bone engagement member guide 24 may be tiltable with respect to an axis X of the bone engagement member guide 24, as shown in Figs. 2 A, 2B, and 2C, or one or more of the bone engagement points may be defined on a structure, such as a discrete pressing element, that can bend, rotate, or telescope to engage the bone. As described above, the bone engagement member guide 24 may be made up of one or more components. The bone engagement member 26 of the guide adapter 14 is configured to engage the end of a bone. For example, in Fig. 3, the bone engagement member 26 includes multiple pressing elements 40 configured to engage the surface of the end of the bone (as illustrated in Figs. 2A and 6A). Turning again to Fig. IA, a compression member 16, which is movable along the bone engagement member guide 24, is attached to the second end of the bone engagement member guide 24 (for example, as shown in Fig. 5A).
A drill guide 52, shown in Fig. 7A, may also be attached to the guide adapter 14, for example, as previously described with reference to Figs. 4 and 7A. The drill guide 52 may be configured to allow the drilling of holes through the bone (i.e., through the patient's soft tissues and into the bone) such that the drilled holes are in alignment with corresponding holes defined by the intramedullary device 12. In this way, fasteners such as screws, pegs, bolts, pins or other fasteners may be inserted through the holes in the bone and received by the corresponding holes in the intramedullary device to hold the bone to the intramedullary device in those locations. In some embodiments, such as the embodiment of Figs. 8 and 9A, a breakaway stud 66 may be used to attach the guide adapter 14 to the proximal end of the intramedullary device 12. In this regard, one end of the breakaway stud 66 may be attached to the proximal end of the intramedullary device 12, and the other end of the breakaway stud 66 may be attached to the first end of the bone engagement member guide 24. As mentioned above, a locking mechanism 78 may be used to hold the breakaway stud 66 and the guide adapter 14 together via transverse locking holes 74, 76, and a lip 15 of the intramedullary device 12 may engage the guide adapter 14 for additional support, as shown in Fig. 1OB.
Once the intramedullary device assembly 10 is assembled and installed in the medullary canal of the affected bone, regardless of the order of the steps, compression may be applied to bring the bone segments on either side of the fracture together, thereby promoting the healing of the bone. According to one embodiment of a method of applying compression, the intramedullary device is inserted into a medullary canal of the bone, for example, as previously described. Referring to Fig. 6A, the intramedullary device 12 is fastened to a distal segment 80 of the bone (a segment located on the distal side of the bone defect relative to the intramedullary device assembly). For example, one or more locking screws 82 may be inserted through intramedullary device holes 22 (shown in Figs. IA and 8) to hold the distal segment 80 to the intramedullary device 12.
Compression may then be applied by advancing the compression member 16 towards the intramedullary device and bone (illustrated in Fig. 5A and indicated by the downward arrow) and into engagement with the bone engagement member 26. For example, in Fig. 5A, the handle 50 of the compression member 16 may be rotated to advance the pushing member 44 into engagement with the bone engagement member 26. As a result, the bone engagement member 26 advances towards the bone, engages the end of the bone, and continues to advance along the bone engagement member guide towards the intramedullary device 12, as illustrated in Fig. 6A, such that the distal segment 80 is moved towards the proximal segment 84 of the bone (i.e., the segment of bone located on the proximal side of the fracture relative to the intramedullary device assembly). The relative movement of the compression member 16, the bone engagement member 26, the bone engagement member guide 24, the intramedullary device 12, and the distal segment 80 are shown in Fig. 6A with arrows on the respective elements.
Referring to Fig. 6B, after the desired amount of compression has been achieved, the intramedullary device 12 may be fastened to the proximal segment 84 to maintain compression of the distal and proximal segments 80, 84. For example, screws, pegs, bolts, pins or other fasteners 82 may be inserted into holes in the intramedullary device 12, bicortically and/or unicortically, to fasten the proximal segment 84 to the intramedullary device 12. In some embodiments, the holes in the distal and/or proximal portions of the intramedullary device 12 may have internal threads (or another type of capturing mechanism) that are configured to engage external threads (or a corresponding capturing mechanism) of the fasteners. Although Figs. 6A and 6B show the screws 82 in this example placed transversely to the device 12 and parallel to the other screws 82, the screws 82 or other fasteners may have various orientations according to the configuration of the receiving holes in the intramedullary device 12 and other considerations to allow for proper fastening between the bone and the intramedullary device 12.
In other embodiments, the proximal segment 84 may be provisionally fixed at intramedullary assembly before compression is applied at the fracture such that compression at the fracture site may be provided without changing the position of the intramedullary device within the proximal segment. In this regard, the compression member may be pre-adjusted such that the bone engagement member is set at a pre-determined point along the guide adapter. Thus, as the intramedullary device is advanced into the medullary canal of the proximal bone segment 84, the bone engagement member is pushed against the end of the bone and the intramedullary device is placed in the correct position in the proximal segment (i.e., the proximal end of the device is aligned flush with the cortex). The entire intramedullary guide assembly may then be pushed toward the distal segment 80, while providing the ability for the surgeon to manually control and adjust the path of advancement of the proximal bone segment 84 towards the distal bone segment 80 by slight rotational or lateral movements of the intramedullary guide assembly until a desired level of initial compression is achieved at the fracture site. The position of the intramedullary device may be adjusted if necessary via the compression member. By pushing the two bone fragments together in this way, the intramedullary device assembly provisionally holds the fracture reduced until the distal screws are in place. If more compression is required, the compression member may be advanced farther along the bone engagement member guide (towards the bone). Once the appropriate amount of compression is achieved, the proximal screws may be put in place.
In any case, the guide adapter, compression member, and other attached accessories (such as the drill guide) may not be needed once the desired amount of compression has been achieved and the intramedullary device 12 has been fastened to the distal and proximal segments 80, 84 of the bone. As a result, the first end of the bone engagement member guide may be detached from the intramedullary device 12, for example by unthreading the bone engagement member guide from the intramedullary device 12. In this way, the intramedullary device 12 may remain in the medullary canal of the bone, with the bone segments 80, 84 attached to facilitate stabilization of the defect and proper healing, and, at the same time, extraneous components of the assembly may be removed to provide a relatively unobstructed surface of the bone and allow the patient to use the affected part to the extent possible with greater comfort. In embodiments that include a breakaway stud (Figs. 8, 9A, and 9B), the guide adapter 14 and the compression member 16 may be detached from the inserted and fastened intramedullary device 12 by removing a locking mechanism before applying force to break the breakaway stud 66 (for example, at the region of concentrated stress 72). For example, referring to Figs. 9A, 9B, and 1OB, the locking mechanism 78 may need to be removed from the holes 74, 76 so that the intramedullary device 12 may be disengaged from the guide adapter 14 (i.e., by disengaging the lip 15). Once disengaged, force may be applied to the assembly to break the breakaway stud 66 and separate the intramedullary device 12 from the rest of the assembly. Furthermore, if removal of the intramedullary device 12 from the bone is required at some later time, the lip 15 may be used to withdraw the intramedullary device 12 from the medullary canal, as previously discussed.
Many modifications and other embodiments of the inventions set forth herein will come to mind to one skilled in the art to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the inventions are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

THAT WHICH IS CLAIMED:
1. An intramedullary device assembly for repairing a defect of a bone, the assembly comprising: an intramedullary device configured to be inserted into the medullary canal of the bone and secured to the bone on either side of the defect; a bone engagement member guide removably attached to an end of the intramedullary device; a compression member that is movable along the bone engagement member guide; and a bone engagement member that is movable along the bone engagement member guide by the compression member, wherein the bone engagement member defines at least two bone engagement points and wherein at least one bone engagement point is movable relative to at least one other bone engagement point in the direction of the bone; wherein the compression member forces the bone engagement member in the direction of the bone along the bone engagement member guide and the at least one bone engagement point is permitted to move relative to the other at least one bone engagement point so that both bone engagement points can engage the end of the bone as compression is applied to the bone.
2. The intramedullary device assembly of Claim 1 , wherein the bone engagement member further comprises at least two pressing elements, and wherein at least two of the pressing elements are rigidly connected together and define bone engagement points, and wherein the relative motion between the bone engagement points is caused by rotation of the bone engagement member relative to the bone engagement member guide.
3. The intramedullary device assembly of Claim 1, wherein the bone engagement member further comprises at least two pressing elements, and wherein at least two of the pressing elements are rigidly connected together and define bone engagement points, and further wherein at least one of the pressing elements is extensible so that the relative motion between the bone engagement points is caused by extension of the at least one prong.
4. The intramedullary device assembly of Claim 1, wherein the bone engagement member guide defines an elongated void, and wherein the bone engagement member includes an internal part configured to be movably retained within the elongated void of the bone engagement member guide and an external part configured to extend outside of the elongated void of the bone engagement member guide and engage the end of the bone via the at least two bone engagement points.
5. The intramedullary device assembly of Claim 4, wherein the compression member is configured to apply force to the internal part of the bone engagement member.
6. The intramedullary device assembly of Claim 4, wherein the external part of the bone engagement member comprises at least one prong configured to engage the end of the bone and a bone engagement point is defined at the end of the at least one prong.
7. The intramedullary device assembly of Claim 6, wherein the external part of the bone engagement member comprises at least two pressing elements each defining a bone engagement point, and at least one of the pressing elements is shorter than at least one other prong.
8. The intramedullary device assembly of Claim 1 , wherein the bone engagement member guide is configured to attach to a drill guide.
9. The intramedullary device assembly of Claim 8, wherein the drill guide is configured to receive a cannula.
10. The intramedullary device assembly of Claim 9, wherein the cannula is configured to serve as a drill guide and depth gauge.
11. The intramedullary device assembly of Claim 8, wherein the bone engagement member guide defines a keyway slot configured to permit alignment of the drill guide with respect to the intramedullary device assembly.
12. The intramedullary device assembly of Claim 11 , wherein an external rotation guide is attached to the drill guide.
13. The intramedullary device assembly of Claim 1 further comprising a breakaway stud connecting the intramedullary device and the bone engagement member guide, wherein the breakaway stud is configured to break when a predetermined amount of force is applied to the intramedullary device assembly such that the breakaway stud can be removed from the intramedullary device.
14. The intramedullary device assembly of Claim 13, wherein the breakaway stud is configured to fit in a corresponding recess in the bone engagement member guide such that rotation of the bone engagement member guide with respect to the device is prevented.
15. The intramedullary device assembly of Claim 13, wherein the bone engagement member guide defines a transverse locking hole, the breakaway stud defines a corresponding transverse locking hole, and the locking holes are configured to receive a locking mechanism such that the bone engagement member guide and the intramedullary device are removably attached together by the locking mechanism.
16. The intramedullary device assembly of Claim 13, wherein the intramedullary device defines a nub having a circumferential lip configured to at least partially engage the bone engagement member guide.
17. The intramedullary device assembly of Claim 1, wherein the intramedullary device defines a plurality of holes to accept a plurality of fasteners for securing the bone to the intramedullary device.
18. The intramedullary device of Claim 17 wherein at least one of the plurality of holes is configured to have a chamfered opening to accept at least one of the respective plurality of fasteners.
19. An intramedullary device assembly for repairing a defect of a bone, the assembly comprising: an intramedullary device configured to be inserted into the medullary canal of the bone and secured to the bone on either side of the defect; a bone engagement member guide removably attached to an end of the intramedullary device; and a bone engagement member comprising a plurality of discrete pressing elements configured to engage an end of the bone, wherein the bone engagement member is movable along the bone engagement member guide, wherein application of force on the bone engagement member in the direction of the bone advances the bone engagement member along the bone engagement member guide towards the intramedullary device and allows at least one of the pressing elements to engage the end of the bone.
20. The intramedullary device assembly of Claim 19, wherein the bone engagement member guide includes a tab configured to fit in a corresponding notch in the intramedullary device to limit rotation of the bone engagement member guide with respect to the intramedullary device.
21. The intramedullary device assembly of Claim 19, wherein the intramedullary device includes a tab configured to fit in a corresponding notch in the bone engagement guide member to limit rotation of the bone engagement member guide with respect to the intramedullary device.
22. The intramedullary device assembly of Claim 19 further comprising a breakaway stud connecting the intramedullary device and the bone engagement member guide, wherein the breakaway stud is configured to break when a predetermined amount of force is applied to the intramedullary device assembly such that the breakaway stud can be removed from the intramedullary device.
23. The intramedullary device assembly of Claim 22, wherein the bone engagement member guide defines a transverse locking hole, the breakaway stud defines a corresponding transverse locking hole, and the locking holes are configured to receive a locking mechanism such that the bone engagement member guide and the intramedullary device are removably attached together by the locking mechanism.
24. The intramedullary device assembly of Claim 22, wherein the intramedullary device defines a nub having a circumferential lip configured to at least partially engage the bone engagement member guide.
25. The intramedullary device assembly of Claim 24, wherein the nub is initially positioned within the bone engagement member guide, and wherein an outer surface of the bone engagement member guide defines an indicator to indicate the position of the nub within the bone engagement guide.
26. A guide adapter for attaching a compression member and drill guide to an intramedullary device comprising: a bone engagement member guide, wherein one end of the bone engagement member guide is configured to engage the intramedullary device and limit rotation of the bone engagement member guide with respect to the intramedullary device, and another end of the bone engagement member guide is configured to support the compression member; and a bone engagement member that is movable along the bone engagement member guide, wherein the bone engagement member defines at least two bone engagement points and wherein at least one bone engagement point is movable relative to at least one other bone engagement point and is configured to engage an end of a bone when the intramedullary device is installed.
27. The guide adapter of Claim 26, wherein the bone engagement member guide defines an elongated void, and wherein the bone engagement member includes an internal part configured to be movably retained within the elongated void of the bone engagement member guide and an external part configured to extend outside of the elongated void of the bone engagement member guide and engage the end of the bone via the at least two bone engagement points.
28. The guide adapter of Claim 27, wherein the external part of the bone engagement member comprises a plurality of pressing elements configured to engage the end of the bone, and at least one of the pressing elements is shorter than at least one other prong.
29. The guide adapter of Claim 26, wherein the bone engagement member guide defines a keyway slot configured to permit alignment of the drill guide with respect to the guide adapter when the drill guide is attached to the guide adapter.
30. The guide adapter of Claim 26, wherein one end of the guide adapter is configured to attach to a breakaway stud connecting the guide adapter to the intramedullary device.
31. A method of assembling an intramedullary device assembly for repairing a defect of a bone comprising: attaching a guide adapter to a proximal end of an intramedullary device, wherein the guide adapter comprises: a bone engagement member guide having a first end configured to attach to the proximal end of the intramedullary device; and a bone engagement member that is movable along the bone engagement member guide, wherein the bone engagement member defines at least two bone engagement points and wherein at least one bone engagement point is movable relative to at least one other engagement point in the direction of the bone; and attaching a compression member to a second end of the bone engagement member guide such that the compression member is movable along an axis of the bone engagement member guide.
32. The method of Claim 31 further comprising attaching a drill guide to the guide adapter, wherein the drill guide is configured to allow drilling holes through the bone that are in alignment with corresponding holes defined by the intramedullary device.
33. The method of Claim 32 wherein a cannula is configured to engage the drill guide to aid the precision of placement and depth of the holes to be drilled.
34. The method of Claim 32 wherein an external rotation guide is configured to allow proper alignment of the drill guide and the bone.
35. The method of Claim 31 , wherein attaching the guide adapter to the proximal end of the intramedullary device comprises attaching a breakaway stud to the proximal end of the device and attaching the first end of the bone engagement member guide to the breakaway stud.
36. The method of Claim 35, wherein attaching the guide adapter to the proximal end of the intramedullary device further comprises engaging the guide adapter with a lip formed on a nub defined by the proximal end of the intramedullary device.
37. The method of Claim 35, wherein attaching the guide adapter to the proximal end of the intramedullary device further comprises inserting a locking mechanism through corresponding transverse locking holes formed in the guide adapter and the breakaway stud.
38. A method of applying compression to repair a defect of a bone using an intramedullary device assembly including an intramedullary device, a bone engagement member guide attached to the intramedullary device, a bone engagement member defining at least two bone engagement points for engaging the bone, the method comprising: inserting the intramedullary device of the intramedullary device assembly into a medullary canal of the bone; securing the intramedullary device to a distal segment of the bone located on a distal side of the defect; permitting movement of at least one bone engagement point of the bone engagement member relative to at least one other bone engagement point in the direction of a proximal segment of the bone; advancing the distal and proximal bone segments towards each other by applying compression to the bone engaging member such that the proximal segment of the bone is moved towards the distal segment of the bone; and securing the intramedullary device to the proximal segment of the bone to maintain the positions of the distal and proximal segments of the bone.
39. The method of Claim 38 further comprising detaching the bone engagement member guide from the intramedullary device after the proximal segment of the bone has been secured.
40. The method of Claim 39 further comprising applying force to a breakaway stud attached to the proximal end of the intramedullary device in order to separate the breakaway stud from the intramedullary device.
41. An intramedullary device and breakaway stud for attaching an intramedullary device to a bone engagement member guide comprising: an intramedullary device configured to be inserted into the medullary canal of a bone and secured to the bone on either side of a defect; and a breakaway stud for being removably attached to the bone engagement member guide comprising: a proximal portion configured to engage the bone engagement member guide; and a distal portion configured to engage the intramedullary device, wherein the distal portion includes a region where stress can be concentrated such that force applied to the breakaway stud causes the breakaway stud to break in the region of concentrated stress.
42. The intramedullary device and breakaway stud of Claim 41 , wherein the proximal portion of the breakaway stud is domino-shaped.
43. The intramedullary device and breakaway stud of Claim 41 , wherein the distal portion of the breakaway stud is tapered.
44. The intramedullary device and breakaway stud of Claim 41 , wherein the region of concentrated stress of the distal portion of the breakaway stud is a region having a cross-sectional area that is smaller than other cross-sectional areas of the breakaway stud.
45. An intramedullary device assembly for repairing a defect in a bone comprising: an intramedullary device configured to be inserted into the medullary canal of the bone and fastened to the bone on either side of the defect by way of at least one fastener received in at least one hole in the intramedullary device; a drill guide configured to align at least one hole drilled through at least a portion of the bone with the respective hole in the intramedullary device so that a fastener can be placed through both aligned holes; a guide adapter configured to attach the drill guide to the intramedullary device; and an external rotation guide configured to facilitate rotational alignment of the intramedullary device within the bone to align the at least one drilled hole with a desired position on the bone.
46. The intramedullary device assembly of Claim 45, wherein the drill guide is configured to receive a cannula in at least one location through which a drill bit is operable.
47. The intramedullary assembly of Claim 45, wherein the cannula is configured to function as a depth gauge of the drill bit within the bone.
PCT/US2008/060294 2008-03-31 2008-04-15 Intramedullary device assembly and associated method WO2009139758A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
CN2008801296513A CN102083374A (en) 2008-03-31 2008-04-15 Intramedullary device assembly and associated method
CA2720116A CA2720116A1 (en) 2008-03-31 2008-04-15 Intramedullary device assembly and associated method
EP08745818A EP2282686B1 (en) 2008-03-31 2008-04-15 Intramedullary device assembly
JP2011502927A JP2011516150A (en) 2008-03-31 2008-04-15 Intramedullary instrument assembly and related methods
BRPI0822414-5A BRPI0822414A2 (en) 2008-03-31 2008-04-15 Intramedullary Device Pool and Associated Method
AU2008356192A AU2008356192B2 (en) 2008-03-31 2008-04-15 Intramedullary device assembly and associated method
IL208398A IL208398A0 (en) 2008-03-31 2010-10-03 Intramedullary device assembly and associated method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/059,701 2008-03-31
US12/059,701 US8152807B2 (en) 2008-03-31 2008-03-31 Intramedullary device assembly and associated method

Publications (3)

Publication Number Publication Date
WO2009139758A2 true WO2009139758A2 (en) 2009-11-19
WO2009139758A3 WO2009139758A3 (en) 2010-03-11
WO2009139758A8 WO2009139758A8 (en) 2010-05-06

Family

ID=41118296

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/060294 WO2009139758A2 (en) 2008-03-31 2008-04-15 Intramedullary device assembly and associated method

Country Status (9)

Country Link
US (1) US8152807B2 (en)
EP (1) EP2282686B1 (en)
JP (1) JP2011516150A (en)
CN (1) CN102083374A (en)
AU (1) AU2008356192B2 (en)
BR (1) BRPI0822414A2 (en)
CA (1) CA2720116A1 (en)
IL (1) IL208398A0 (en)
WO (1) WO2009139758A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010141183A1 (en) * 2009-06-04 2010-12-09 Olecranail Llc Intramedullary device assembly and associated method

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0718417D0 (en) 2007-09-21 2007-10-31 Depuy Int Ltd Intramedullary rod instrument
GB201019490D0 (en) * 2010-11-18 2010-12-29 Depuy Ireland Angular adjustment mechanism, surgical alignment guide and surgical instrument assembly
US11000387B2 (en) 2011-09-02 2021-05-11 Episurf Ip-Management Ab Implant for cartilage repair
US10603049B2 (en) 2011-09-02 2020-03-31 Episurf Ip-Management Ab Implant specific drill bit in surgical kit for cartilage repair
EP2564792A1 (en) * 2011-09-02 2013-03-06 Episurf Medical AB Modular surgical kit for cartilage repair
CA2862441A1 (en) 2011-12-29 2013-07-04 DePuy Synthes Products, LLC Suprapatellar insertion system, kit and method
US9907562B2 (en) 2013-03-15 2018-03-06 Paragon 28, Inc. Intramedullary nail fixation guides, devices and methods of use
CN104095664B (en) 2013-04-12 2016-12-28 德普伊(爱尔兰)公司 Distal femur clamp assembly and the distal femur cutting device with this assembly
KR101501723B1 (en) * 2013-10-30 2015-03-11 주식회사 제일메디칼코퍼레이션 device for broken bone moving
CN103610496B (en) * 2013-11-29 2015-06-17 常州华森医疗器械有限公司 Guide pipe base for intramedullary nail punching device
USD904616S1 (en) 2014-03-14 2020-12-08 Paragon 28, Inc. Intramedullary fastener
WO2016004991A1 (en) 2014-07-09 2016-01-14 Episurf Ip-Management Ab Customized implant for cartilage repair and corresponding method of design
EP3166540B1 (en) 2014-07-09 2019-06-19 Episurf IP-Management AB A surgical joint implant
US9386995B1 (en) 2015-06-11 2016-07-12 Jake Doroshow Apparatus and method for guiding a surgical drill during orthopedic surgery
US10251682B2 (en) * 2017-03-22 2019-04-09 DePuy Synthes Products, Inc. Distal radius nail
US10492839B2 (en) * 2017-04-30 2019-12-03 Felasfa Wodajo Expandable osseointegration bone fixation apparatus for use in a variety of settings
IT201700048446A1 (en) * 2017-05-04 2018-11-04 Orthofix Srl Improved bone screw for the treatment of sagging or bone deformation, such as in the case of the Charcot foot, and insertion instruments in the bone screw of anti-migration elements
US11446072B2 (en) * 2017-10-10 2022-09-20 DePuy Synthes Products, Inc. Self-retaining nail to insertion handle interface
USD894385S1 (en) 2017-10-27 2020-08-25 Orthopediatrics Corp. Orthopedic tool
US10610274B2 (en) * 2018-02-27 2020-04-07 Jonathan P. GARINO Instrument for fracture alignment and plate compression
EP3920817A1 (en) * 2019-02-08 2021-12-15 Disrad Ag Distal radius fracture fixation device
US11185355B2 (en) * 2019-08-05 2021-11-30 DePuy Synthes Products, Inc. Guide sleeve for fine axial adjustability of a fixation member, and related systems and methods
US11931082B2 (en) * 2021-05-11 2024-03-19 Zimmer, Inc. Surgical instruments with compliant distal stud connection

Family Cites Families (56)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5253198Y2 (en) * 1972-07-20 1977-12-02
US3858866A (en) * 1973-03-06 1975-01-07 Ernie R Armstrong Adjustable template for supporting and aligning tower footings
IL48826A (en) 1976-01-13 1978-08-31 Aginsky Yacov Intramedullary compression nail for the treatment of bone fractures
US4103683A (en) 1977-06-03 1978-08-01 Neufeld John A Sub-trochanteric nail
DE2830566A1 (en) 1978-07-12 1980-01-24 Gustav Neuhaeuser Praezisionsw Hip-bone recess former - has adjustable alignment and guide mechanism which is automatically locked in set position
CH666176A5 (en) * 1984-11-30 1988-07-15 Straumann Inst Ag DEVICE FOR TREATING A BONE AND NAIL FOR SUCH A DEVICE.
DE3734111A1 (en) 1987-10-06 1989-04-20 Mecron Med Prod Gmbh INTERMEDIATE NAIL FOR TREATMENT OF BONE BREAKS ACCORDING TO THE PRINCIPLE OF MARBLE NAILING AND MARNEL TOOL
US4875474A (en) 1988-01-29 1989-10-24 Biomet, Inc. Variable wall thickness interlocking intramedullary nail
US4911153A (en) 1988-02-04 1990-03-27 Biomet, Inc. Orthopedic surgical instrument
DE3840798A1 (en) 1988-12-01 1990-06-21 Mecron Med Prod Gmbh MARKING NAIL
US5013317A (en) 1990-02-07 1991-05-07 Smith & Nephew Richards Inc. Medical drill assembly transparent to X-rays and targeting drill bit
US5030222A (en) 1990-05-09 1991-07-09 James Calandruccio Radiolucent orthopedic chuck
US5100404A (en) 1990-09-04 1992-03-31 Beth Israel Hospital Intramedullary nailing method and apparatus
US5108398A (en) 1990-10-16 1992-04-28 Orthopaedic Research Institute Orthopaedic knee fusion apparatus
CH682212A5 (en) 1990-12-19 1993-08-13 Synthes Ag
US5207753A (en) 1991-02-18 1993-05-04 Kannivelu Badrinath Bone fracture repair apparatus and method
US6001104A (en) 1991-12-03 1999-12-14 Boston Scientific Technology, Inc. Bone anchor implantation device
US5284313A (en) 1992-01-08 1994-02-08 Ablenet, Inc. Mounting system
US5352228A (en) 1993-05-10 1994-10-04 Kummer Frederick J Apparatus and method to provide compression for a locked intramedullary nail
US5472444A (en) 1994-05-13 1995-12-05 Acumed, Inc. Humeral nail for fixation of proximal humeral fractures
JP3441513B2 (en) 1994-05-20 2003-09-02 ペンタックス株式会社 Mounting jig for intramedullary nail
GB9411693D0 (en) 1994-06-10 1994-08-03 Matthews Michael G Surgical intramedullary nail for stabilisation of condylar and supracondylar fractures
US5484446A (en) 1994-06-27 1996-01-16 Zimmer, Inc. Alignment guide for use in orthopaedic surgery
US5910143A (en) 1994-12-16 1999-06-08 Exactech, Inc. Intramedullary alignment guide tool
US5569262A (en) * 1995-05-19 1996-10-29 Carney; William P. Guide tool for surgical devices
US5766174A (en) 1995-09-26 1998-06-16 Orthologic Corporation Intramedullary bone fixation device
DE29608071U1 (en) 1996-05-04 1997-09-04 Synthes Ag Aiming device for locking the foot area of intramedullary nails
US6228086B1 (en) 1997-03-19 2001-05-08 Stryker Trauma-Selzach Ag Modular intramedullary nail
US6270499B1 (en) * 1997-10-20 2001-08-07 Synthes (U.S.A.) Bone fixation device
US6036696A (en) 1997-12-19 2000-03-14 Stryker Technologies Corporation Guide-pin placement device and method of use
DE29804268U1 (en) 1998-03-11 1998-05-14 Synthes Ag Spiral blade insertion instrument
US5951561A (en) 1998-06-30 1999-09-14 Smith & Nephew, Inc. Minimally invasive intramedullary nail insertion instruments and method
US6183477B1 (en) 1998-09-04 2001-02-06 Smith & Nephew, Inc. Attachment tool for drill guide
US6120504A (en) 1998-12-10 2000-09-19 Biomet Inc. Intramedullary nail having dual distal bore formation
US6783529B2 (en) 1999-04-09 2004-08-31 Depuy Orthopaedics, Inc. Non-metal inserts for bone support assembly
US6296645B1 (en) 1999-04-09 2001-10-02 Depuy Orthopaedics, Inc. Intramedullary nail with non-metal spacers
US6402766B2 (en) * 1999-07-23 2002-06-11 Ethicon, Inc. Graft fixation device combination
US6805695B2 (en) * 2000-04-04 2004-10-19 Spinalabs, Llc Devices and methods for annular repair of intervertebral discs
US6808527B2 (en) 2000-04-10 2004-10-26 Depuy Orthopaedics, Inc. Intramedullary nail with snap-in window insert
US7066943B2 (en) 2001-03-30 2006-06-27 Zirkle Jr Lewis G Method and apparatus for locating and stabilizing an orthopedic implant
US6443954B1 (en) 2001-04-24 2002-09-03 Dale G. Bramlet Femoral nail intramedullary system
EP1408856B1 (en) * 2001-06-27 2010-12-01 DePuy Products, Inc. Minimally invasive orthopaedic apparatus
KR100485896B1 (en) 2002-01-17 2005-04-29 조우신 Device for inserting screws into an intramedullary nail and method thereof
US7056322B2 (en) 2002-03-28 2006-06-06 Depuy Orthopaedics, Inc. Bone fastener targeting and compression/distraction device for an intramedullary nail and method of use
US7198642B2 (en) * 2003-03-31 2007-04-03 Depuy Products, Inc. Orthopaedic spacer
ATE533419T1 (en) 2003-05-17 2011-12-15 Depuy Int Ltd INTEGRAL NAIL SYSTEM
US7033363B2 (en) 2004-05-19 2006-04-25 Sean Powell Snap-lock for drill sleeve
US20060015101A1 (en) * 2004-07-15 2006-01-19 Wright Medical Technology, Inc. Intramedullary fixation assembly and devices and methods for installing the same
US7451550B2 (en) 2004-12-21 2008-11-18 Smith & Nephew, Inc. Rotational alignment femoral sizing guide
GB2423021A (en) 2005-02-15 2006-08-16 Biomet Uk Ltd A surgical guide jig with an expanding spherical joint
ES2606064T3 (en) 2005-02-22 2017-03-17 Smith & Nephew, Inc. Instrument for orienting fixing screws
WO2007089637A2 (en) * 2006-01-27 2007-08-09 Smith & Nephew, Inc. Assemblies for the reduction of a fracture
CA2651587C (en) 2006-05-09 2016-03-22 Synthes (U.S.A.) Nail system and method for an olecranon osteotomy
JP4512902B2 (en) * 2006-07-13 2010-07-28 尚美 井上 Intramedullary nail positioning device
US20080147066A1 (en) 2006-12-19 2008-06-19 Zimmer Technology, Inc. Bone fixing system
US8784430B2 (en) 2007-04-26 2014-07-22 Zimmer, Inc. Nail cap cannula

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010141183A1 (en) * 2009-06-04 2010-12-09 Olecranail Llc Intramedullary device assembly and associated method
US8216237B2 (en) 2009-06-04 2012-07-10 Edwards Scott G Intramedullary device assembly and associated method

Also Published As

Publication number Publication date
JP2011516150A (en) 2011-05-26
AU2008356192A1 (en) 2009-11-19
US20090248024A1 (en) 2009-10-01
EP2282686A2 (en) 2011-02-16
WO2009139758A3 (en) 2010-03-11
AU2008356192B2 (en) 2012-09-20
BRPI0822414A2 (en) 2015-06-16
US8152807B2 (en) 2012-04-10
WO2009139758A8 (en) 2010-05-06
IL208398A0 (en) 2010-12-30
EP2282686B1 (en) 2012-12-19
CA2720116A1 (en) 2009-11-19
CN102083374A (en) 2011-06-01

Similar Documents

Publication Publication Date Title
US8152807B2 (en) Intramedullary device assembly and associated method
US8216237B2 (en) Intramedullary device assembly and associated method
EP1976442B1 (en) Assemblies for the reduction of a fracture
EP1878394B1 (en) Orthopaedic fixation plate having threaded guides
EP2231034B1 (en) Guide assembly for intramedullary fixation
US9848923B2 (en) Locking system for orthopedic implants
AU2007200166B2 (en) Medical system, body implant, adaptor device and method for spatially adjusting an aiming device relative to the body implant
US20140243825A1 (en) Compressible device assembly and associated method for facilitating healing between bones
JP2016504961A (en) Sighting instrument
CA2693770C (en) Surgical drill guide having keyway for axial alignment of fastener used for an orthopedic plate
WO2019227103A1 (en) Systems and methods for fusion of anatomical joints
EP4008274A1 (en) Minimally invasive surgery targeting guides
US11583328B2 (en) Femoral nail and instrumentation system
EP1808138B1 (en) Medical system and system parts for spatially adjusting an aiming device relative to a body implant
EP4104780A1 (en) Targeting guide
EP4104776A2 (en) Minimally invasive surgery osteotomy fragment shifter, stabilizer, and targeter
EP2762097B1 (en) Modular lag screw

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 200880129651.3

Country of ref document: CN

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 08745818

Country of ref document: EP

Kind code of ref document: A2

DPE1 Request for preliminary examination filed after expiration of 19th month from priority date (pct application filed from 20040101)
WWE Wipo information: entry into national phase

Ref document number: 2720116

Country of ref document: CA

Ref document number: 2011502927

Country of ref document: JP

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 2008356192

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 2008745818

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 2008356192

Country of ref document: AU

Date of ref document: 20080415

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: PI0822414

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20100929