Bone reconstruction systems and methods
The bone reconstruction system addresses the limitations of current technologies by using an external fixation frame with modular components for precise alignment and resection, achieving accurate and efficient bone reconstruction.
Patent Information
- Application Number
- PCT/US2024/052918
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-10-26
- Filing Date
- 2024-10-25
- Publication Date
- 2025-05-01
AI Technical Summary
Current bone reconstruction technologies are limited by imprecision, high costs, and time-consuming processes, particularly in achieving accurate and rapid intraoperative bone reconstruction.
The system employs an external fixation frame with modular components, including resection guides and multi-degree of freedom connectors, to securely attach and align bone segments, allowing for precise resections and accurate reconstruction of bone geometry.
This approach enables flexible, accurate, and cost-effective bone reconstruction, minimizing deformities and maximizing musculoskeletal function, while being applicable to a wide range of oncologic and non-oncologic procedures.
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Figure US2024052918_01052025_PF_FP_ABST
Abstract
Description
BONE RECONSTRUCTION SYSTEMS AND METHODSCROSS REFERENCE TO RELATED APPLICATIONS
[0001] This patent application claims the benefit of the filing date and priority to United States Provisional Patent Application Serial Number 63 / 593,257 filed October 26, 2023 for "Bone Reconstruction Systems And Methods," the entire contents of which is hereby incorporated by this reference.RELATED FIELDS
[0002] Systems and methods for reconstructing bones, such as systems and methods for resecting a diseased or damaged bone segment and replacing the resected segment with an allograft bone, biomaterial, or metal prosthesis of substantially the same dimensions and geometry as the resected segment.BACKGROUND
[0003] Bone reconstruction procedures involve removing a tumor-filled or otherwise diseased or damaged bone segment and replacing the removed segment with an allograft bone, biomaterial, or metal prosthesis. Ideally the replacement allograft material will have the same or similar dimensions and geometries of the removed bone segment. Ideally these procedures could be performed quickly and accurately, minimizing deformities, and maximizing musculoskeletal function. Current technologies for rapid, accurate, intraoperative bone reconstruction are quite limited. Most treatments involve free-hand techniques and simple rulers. Free-hand techniques are highly imprecise. Other techniques use digital computer navigation technologies; however, such procedures are time consuming and expensive, require high initial capital expenses for the digital navigation equipment, and provide limited intraoperative functionality. Other techniques use prefabricated three-dimensional custom cutting guides; however, these technologies are inflexible, expensive, and are time consuming to fabricate. Additionally, if the custom cutting guide is not accurately prepared there may be no easy intraoperative solution to the problem.SUMMARY
[0004] This patent describes improved systems and methods for bone reconstruction. In some implementations the systems and methods may be used to remove and replace a bone portion with an implant, which may be an allograft, biomaterial, metal implant, or any other type of implant. The systems and methods facilitate making accurate cuts in bone to remove a diseased bone portion and then reproduce the cuts in a donor bone to recreate the precise geometry of the removed portion. The system can check the accuracy of reconstruction when a segment of bone is replaced, regardless of the biomaterial or implant type. This capability makes the system applicable to a broad range of oncologic procedures, including endoprosthetic replacement of the distal femur and proximal tibia, which are frequently done for osteosarcoma and other oncologic conditions. Removal of the distal femur and proximal tibia is commonly done for non-oncologic purposes as well, most notably for revision of failed knee replacements. In addition to the distal femur and proximal tibia, resection and reconstruction of any long bones, such as the proximal femur and humerus, can benefit from the new system. Implementations of the systems and methods described herein include benefits such as intraoperative flexibility, minimal preoperative planning, improved performance of precise resections in the patient's bone and the allograft material, reusability, accurate assessment of bone reconstruction, and low cost.
[0005] The systems and methods described herein utilize an external fixation frame for fixing the relative position and orientation of bone segments and / or resection guides during bone reconstruction. In some implementations, the frame enables the surgeon toassess the accuracy of reconstruction after the new material has been inserted into the defect via a special modular pointer attachment. In some implementations, the system may include two unique types of bone-attachment foot pieces, one with bicortica I thin pin fixation and the other with unicortical screw fixation. In some implementations, the system may also feature a rapid detachment mechanism with a means of locking the rotational alignment of the posts into the foot pieces. In some implementations, the special cutting guides allow any diaphyseal segment of bone to be reproduced with respect to length and osteotomy planes, regardless of rotation or angulation.
[0006] In one example a bone reconstruction method includes securing first and second frame supports to bony anatomy and securing an elongated fixation from to the first and second frame supports. The first frame support is secured to a first location on a bony anatomy, the bony anatomy including a bone portion for reconstruction. The second frame support is secured to a second location on the bony anatomy, with the bone portion for reconstruction located between the first and second locations. The elongated fixation frame is secured to the first and second frame supports such that the elongated fixation frame spans across the bone portion for reconstruction. The method further includes in this example, with at least part of the first frame support and part of the second frame support remaining secured to the first and second locations, performing at least one resection to separate the bone portion for reconstruction from the bony anatomy. The method further includes in this example, implanting a bone reconstruction implant, and the elongated frame is either still attached or is re-attached to the first and second frame supports secured at the first and second locations after the bone reconstruction implant is implanted.
[0007] In some implementations the method further includes securing a resection guide to the bony anatomy between the first and second frame supports, in which performingthe at least one resection includes using the resection guide to guide a cutter to perform the at least one resection.
[0008] In some implementations the method further includes securing a second resection guide to the bony anatomy between the first and second frame supports; and using the second resection guide to guide the cutter to perform a second resection.
[0009] In some implementations the method further includes securing the first resection guide to the second resection guide such that a relative position and relative orientation of the first resection guide to the second resection guide is fixed.
[0010] In some implementations securing the first resection guide to the second resection guide includes using multi-degree of freedom clamps to secure the first and second resection guides to an auxiliary fixation frame.
[0011] In some implementations the method further includes, while the first and second resection guides are secured to the auxiliary fixation frame, using the first and second resection guides to guide resections of the bone reconstruction implant.
[0012] In some implementations securing the first frame support to the first location on the bony anatomy includes securing a first distal bone fixation end of the first frame support to the first location; and securing the second frame support to the second location on the bony anatomy includes securing a second distal bone fixation end on the second frame support to the second location.
[0013] In some implementations the first frame support includes a first elongate member extending from the first distal end; the second frame support includes a second elongate member extending from the second distal end; and securing the elongated fixation frame to the first and second frame supports includes clamping the first and second elongate frame members to the elongated fixation frame.
[0014] In some implementations multi-degree of freedom clamps are used to clamp the first and second elongate frame members to the elongated fixation frame.
[0015] In some implementations the first frame support includes a first connector detachably connecting the first distal end from a first proximal end of the first frame support; and the second frame support includes a second connector detachably connecting the second distal end from a second proximal end of the second frame support.
[0016] In some implementations, the method further includes, after securing the elongated fixation frame to the first and second frame supports, detaching as a single unit the elongated fixation frame, the first proximal end of the first frame support, and the second proximal end of the second frame support from the first and second distal ends of the first and second frame supports; and subsequently re-attaching as the single unit the elongated fixation frame, the first proximal end of the first frame support, and the second proximal end of the second frame support to the first and second distal ends of the first and second frame supports.
[0017] In some implementations the at least one resection is performed with the first and second distal ends of the first and second frame supports secured to the first and second locations of the bony anatomy and the first and second proximal ends disconnected from the first and second distal ends of the first and second frame supports.
[0018] In another example a bone reconstruction system includes frame supports, an elongated fixation frame, and multi-degree of freedom connectors. A first frame support includes a first distal bone fixation end configured to receive a first fastener, the first distal bone fixation end including a first bone referencing surface. A second frame support includes a second distal bone fixation end configured to receive a second fastener, the second distal bone fixation end including a second bone referencing surface. A first multi-degree of freedomconnector is configured to connect the first frame support to the elongated fixation frame with multiple degrees of freedom. The second multi-degree of freedom connector is configured to connect the second frame support to the elongated fixation frame with multiple degrees of freedom.
[0019] In some implementations the first frame support includes a first elongate member extending from the first distal bone fixation end, the first elongate member detachably connected to the first distal bone fixation end; and the second frame support includes a second elongate member extending from the second distal bone fixation end, the second elongate member detachably connected to the second distal bone fixation end.
[0020] In some implementations the first and second frame supports include pull out connections detachably connecting the first and second elongate members to the first and second distal bone fixation ends.
[0021] In some implementations the pull out connection of the first frame support includes a different shape from the pull out connection of the second frame support.
[0022] In some implementations the first and second bone referencing surfaces are concave surfaces.
[0023] In some implementations the system further includes a resection guide position-able between the first and second frame supports, the resection guide including a resection guide surface for guiding a resection.
[0024] In some implementations the system further includes a kerf spacer including a bone resection referencing surface and an allograft resection guide surface; and a resection cutter with a kerf width. The bone resection referencing surface may be spaced from the allograft resection guide surface by the kerf width.
[0025] In some implementations the first multi-degree of freedom connector has an unlocked state in which the elongated fixation frame is rotatable and translatable relative to the first frame support and a locked state in which the elongated fixation frame is fixed relative to the first frame support; and the second multi-degree of freedom connector has an unlocked state in which the elongated fixation frame is rotatable and translatable relative to the second frame support and a locked state in which the elongated fixation frame is fixed relative to the second frame support.
[0026] In some implementations the system further includes an alignment pointer detachably connectable to one of the first and second frame supports.
[0027] In some implementations the system further includes a computer assisted surgery fiducial detachably connectable to one of the first frame support, second frame support, or elongated fixation frame.
[0028] In another example a bone reconstruction system includes: an external fixation frame; a first frame support connected to the external fixation frame and including a first distal bone fixation end; a second frame support connected to the external fixation frame and including a second distal bone fixation end; a first resection guide connected to the external fixation frame between the first and second frame supports, the first resection guide including a first resection guide surface for guiding a first resection; and a second resection guide connected to the external fixation frame between the first and second frame supports, the second resection including a second resection guide surface for guiding a second resection.
[0029] In some implementations of this example the first resection guide has an unlocked state in which the first resection guide is translatable and rotatable relative to the external fixation frame and a locked state in which a position and an orientation of the first resection guide relative to the external fixation frame is fixed. Furthermore, the secondresection guide has an unlocked state in which the second resection guide is translatable and rotatable relative to the external fixation frame and a locked state in which a position and an orientation of the second resection guide relative to the external fixation frame is fixed.
[0030] In some implementations of this example the first frame support has an unlocked state in which the first frame support is translatable and rotatable relative to the external fixation frame and a locked state in which a position and an orientation of the first frame support relative to the external fixation frame is fixed. Furthermore, the second frame support has an unlocked state in which the second frame support is translatable and rotatable relative to the external fixation frame and a locked state in which a position and an orientation of the second frame support relative to the external fixation frame is fixed.
[0031] In some implementations of this example the first and second resection guides and the first and second frame supports each are connected to the external fixation frame by a multi-degree of freedom clamp.
[0032] In some implementations of this example the multi-degree of freedom clamps are lockable and unlockable.
[0033] In some implementations of this example at least one of the multi-degree of freedom clamps includes a first clamping unit and a second clamping unit.
[0034] In some implementations of this example unlocking of the first clamping unit allows rotational and translational adjustment of the multi-degree of freedom clamp relative to the external fixation frame. Furthermore, unlocking of the second clamping unit allows rotation and translation adjustment of the frame support or resection guide connected to the multi-degree of freedom clamp.
[0035] In some implementations of this example the multi-degree of freedom clamps each include a lock configured to simultaneously unlock both the first and second clamping units.
[0036] In some implementations of this example unlocking the lock allows rotational movement of the first clamping unit relative to the second clamping unit.
[0037] In some implementations of this example the distal bone fixation ends of the first and second frame supports are each configured to removably receive one or more fixation elements.
[0038] In some implementations of this example the distal bone fixation ends of the first and second frame supports each has one or more apertures for receiving the fixation elements.
[0039] In some implementations of this example the distal bone fixation ends of the first and second frame supports each includes a concave bone referencing surface.
[0040] In some implementations of this example the first and second resection guide surfaces of the first and second resection guides have planar exterior surfaces on bodies of the first and second resection guides.
[0041] In some implementations of this example the first and second resection guide surfaces of the first and second resection guides have first and second resection guide slots extending through the first and second resection guides.
[0042] In some implementations of this example the first and second resection guides each has a concave bone facing surface.
[0043] In some implementations of this example at least one of the first and second resection guides has an additional parallel resection guide slot.
[0044] In some implementations of this example the bone reconstruction system also includes: a kerf spacer having a bone resection referencing surface and an allograft resection guide surface; and a resection cutter having a kerf width. The bone resection referencing surface may be spaced from the allograft resection guide surface by the kerf width.
[0045] In some implementations of this example the external fixation frame is an elongated frame member.
[0046] In some implementations the external fixation frame is at least two elongated frame members connected together by an adjustable connector.
[0047] In some implementations the adjustable connector has an unlocked state in which the elongated frame members are rotatable and translatable relative to one another and a locked state in which the elongated frame members are fixed relative to one another.
[0048] In another example a bone reconstruction method includes: securing an external fixation frame to a bone; positioning and orienting a first resection guide to correspond to a first bone resection; after positioning and orienting the first resection guide to correspond to the first bone resection, locking the position and orientation of the first resection guide relative to the external fixation frame; positioning and orienting a second resection guide to correspond to a second bone resection in the bone; after positioning and orienting the second resection guide to correspond to the second bone resection, locking the position and orientation of the second resection guide relative to the external fixation frame; with the positions and orientations of the first and second resection guides locked, removing the external fixation frame from the bone and securing the external fixation frame to an allograft or a biomaterial; performing a first and a second resection on the allograft or the biomaterial based on the locked positions and orientations of the first and second resection guides; and implanting the allograft or the biomaterial in the bone.
[0049] In some implementations securing the external fixation frame to the bone includes securing first and second frame supports to the bone and securing the external fixation frame to the first and second frame supports.
[0050] In some implementations securing the external fixation frame to the first and second frame supports includes securing a first elongated frame member to the first frame support, securing a second elongated frame member to the second frame support, and securing the first and second elongated frame members together.
[0051] In some implementations securing first and second frame supports to the bone includes securing the first and second frame supports to the bone at locations that are proximal and distal to a resection segment of the bone.
[0052] In some implementations positioning and orienting the first and second resection guides to correspond to the first and second bone resections includes positioning and orienting the first and second resection guides to correspond to planned positions and orientations for the first and second bone resections.
[0053] In some implementations positioning and orienting the first and second resection guides to correspond to the first and second bone resections includes positioning and orienting the first and second resection guides to correspond to previously performed first and second bone resections.
[0054] In some implementations positioning and orienting the first and second resection guides to correspond to the first and second bone resections includes: (a) positioning and orienting the first resection guide using a kerf spacer such that a planar resection guide surface of the first resection guide is positioned and oriented parallel to the first bone resection and spaced from the first bone resection by a kerf width of a resection cutter; and (b) positioning and orienting the second resection guide using the kerf spacer suchthat a planar resection guide surface of the second resection guide is positioned and oriented parallel to the second bone resection and spaced from the second bone resection by the kerf width of the resection cutter.
[0055] In some implementations the method also includes, after implanting the allograft or the biomaterial in the bone, re-attaching the external fixation frame to the bone to check alignment.
[0056] In some implementations the external fixation frame includes an elongated frame member and an auxiliary elongated frame member, with the first and second resections guides being secured to the auxiliary elongated frame member, and with the auxiliary elongated frame member secured to the elongated frame member. Removing the external fixation frame from the bone includes removing the auxiliary elongated frame member and the first and section resection guides from the elongated frame member as a locked unit, and securing the external fixation frame to the allograft or biomaterial includes securing the auxiliary elongated frame member and the first and second resection guides to the allograft as a locked unit.BRIEF DESCRIPTION OF FIGURES
[0057] FIG. 1 schematically shows an example of a bone reconstruction system.
[0058] FIG. 2 schematically shows another example of a bone reconstruction system.
[0059] FIG. 3A and 3B show examples of resection guides of a bone reconstruction system.
[0060] FIGS. 4-6 show additional examples of resection guides of a bone reconstruction system.
[0061] FIGS. 7A and 7B show additional examples of resection guides of a bone reconstruction system.
[0062] FIG. 8 shows an example of a kerf spacer for use with a resection guide of a bone reconstruction system.
[0063] FIGS. 9-10 shows an example of a frame support of a bone reconstruction system.
[0064] FIG. 11 shows an example of a multi-degree of freedom clamp of a bone reconstruction system.
[0065] FIGS. 12-21 show an example of a bone reconstruction method.
[0066] FIGS. 22-33 show another example of a bone reconstruction method.
[0067] FIG. 34 schematically shows another example of a bone reconstruction system.
[0068] FIG. 35 shows another example of a multi-degree of freedom clamp of a bone reconstruction system.
[0069] FIGS. 36-42 shows additional examples of frame supports of a bone reconstruction system.
[0070] FIGS. 43-45 show an example of a pointer of a bone reconstruction system.
[0071] FIGS. 46-56 schematically show another example of a bone reconstruction method.
[0072] FIGS. 57-59 schematically show another example of a bone reconstruction method.DETAILED DESCRIPTION
[0073] FIGS. 1-11 and 34-45 show examples of bone reconstruction systems and components of bone reconstruction systems. FIGS. 12-33 and 46-59 show examples of bone reconstruction methods. The bone reconstruction systems and components of FIGS. 1-11 and 34-45 may be used to perform the bone reconstruction methods of FIGS. 12-33 and 46-59 or may be used for other bone reconstruction methods. The bone reconstruction methods ofFIGS. 12-33 and 46-59 may use the bone reconstruction systems and components of FIGS. 1-11 and 34-45 or may use other systems and components.Example Bone Reconstruction Systems
[0074] FIG. 1 shows one example of a bone reconstruction system. In this example the system includes an external fixation frame 10, frame supports 12 connected to the external fixation frame 10, and resection guides 14 connected to the external fixation frame 10. The frame supports 12 include distal bone fixation ends 16 where the external fixation system may be fixed to a bone 100 by fixation elements 18. The resection guides 14 are located between the frame supports 12 and include guide surfaces for guiding resections in bone 100.
[0075] In the example of FIG. 1 multi-degree of freedom clamps 20 connect the frame supports 12 and resection guides 14 to the external fixation frame 10. The clamps 20 are lockable and unlockable such that the frame supports 12 and resections guides 14 can each be in either an unlocked state or a locked state. In the unlocked state the frame support 12 or resection guide 14 is translatable and rotatable relative to the external fixation frame 10. In the locked state the frame support 12 or resection guide 14 is fixed in position and orientation relative to the external fixation frame 10.
[0076] In the FIG. 1 example the external fixation frame 10 consists of a single elongated frame member. In some implementations the elongated frame member may be a stainless steel rod or other sufficiently rigid length of material. In some implementations the elongated frame member may have a circular cross section or other cross section geometry that facilitates positioning the clamps 20 in a variety of rotational orientations relative to the elongated frame member. In some implementations the elongated frame member may have a relatively uniform cross section along some or all of its length to facilitate positioning theclamps 20 in a variety of translational positions along some or all of the length of the elongated frame member.
[0077] In the FIG. 1 example the external fixation frame 10 consists of a single elongated frame member. In the FIG. 2 example the external fixation frame 10 consists of multiple elongated frame members 22 connected by multiple adjustable connectors 24. In some implementations the adjustable connectors 24 may be the same as or configured similarly to the multi-degree of freedom clamps 20. When the adjustable connectors 24 are in an unlocked state, the associated elongated frame members 22 are rotatable and translatable relative to one another. When the adjustable connectors 24 are in a locked state, the associated elongated frame members 22 are fixed relative to one another. The multiple elongated frame members 22 and adjustable connectors 24 may in some implementations facilitate independently fixing one or more of the other components of the external fixation system to bone 100 prior to connecting them together in a single unit.Example Resection Guides
[0078] FIGS. 3-8 show examples of resection guides usable with the external fixation frame systems shown in FIGS. 1-2.
[0079] In the FIG. 3A example the resection guide includes a planar resection guide surface 26 on the exterior of its body 28 for guiding a resection in bone and / or an allograft material. The resection guide of FIG. 3A also includes an elongated member 30 extending from the body for connecting to a multi-degree of freedom clamp. In some implementations the elongated member 30 may have a circular cross section or other cross section geometry that facilitates positioning the clamp 20 in a variety of rotational orientations relative to the elongated member 30. In some implementations the elongated member 30 may have a relatively uniform cross section along some or all of its length to facilitate positioning theclamp 20 in a variety of translational positions along some or all of the length of the elongated frame member 30.
[0080] In the example shown in FIG. 3A the distal bone facing surface 32 of the resection guide body 28 is concave to facilitate relatively close positioning of the resection guide surface 26 about part of the circumference of the bone.
[0081] FIG. 3B shows another resection guide that has similar features and functionality to the resection guide of FIG. 3A, except that the resection guide of FIG. 3B has a slimmer profile. In some implementations a slimmer profile guide may reduce the among of bone exposure required for guide placement and reduce potential interference with other anatomy, instrumentation, and other items in the operating window.
[0082] FIGS. 4-6 show several views of another example of a resection guide usable with the bone reconstruction systems of FIGS. 1 and 2. FIGS. 4B and 6B show a lower profile version of the resection guide shown in FIGS. 4A, 5, and 6A, with both resection guides having similar features and functionality. In the examples of FIGS. 4-6 the resection guide surface is in a slot 34 extending through the body of the guide, rather than an exterior surface of the guide as shown in FIG. 3. Additionally, the resection guides of FIGS. 4-6 have openings 36 for receiving fixation elements (e.g. pins or screws) for further securing the resection guide in place. FIGS. 6A and 6B show cross sections of the resection guides of FIGS. 4-6, showing that the openings 36 are converging, enhancing the fixing strength of the fixation elements to the bone or allograft material.
[0083] FIGS. 7A and B show additional examples of resection guides usable with the bone reconstruction systems of FIGS. 1 and 2. In these examples the guides include a resection guide slot 34 and an additional resection guide slot 38 with a guide surface that is parallel to the resection guide slot 34. The guide slots 34, 38 are spaced apart by an approximate kerfwidth of a cutter, allowing use of one of the guide slots for resecting bone and the other guide slot for respecting the allograft material.
[0084] As discussed further below, in some example methods of use it may be desirable to position and orient the guide surface of a resection guide to account for the kerf width of the particular resection blade being used for the procedure. FIG. 8 shows an example of a kerf spacer 40 that can be used to account for the kerf width of a resection blade 42. The kerf spacer 40 in this example includes a bone resection referencing surface 44 for referencing a previously performed bone resection in bone segment 102. The kerf spacer 40 also includes an allograft resection guide surface 46 that acts as a reference surface for positioning and orienting a resection guide surface (e.g. resection guide surface 26 of the resection guide in FIG. 3) for a planned resection in an allograft material. The bone resection referencing surface 44 and the allograft resection guide surface 46 are spaced apart by a width 48 that is the same as the width 50 of the resection blade 42.
[0085] In the particular example shown in FIG. 8 the kerf spacer 40 is configured for use with a resection guide with the resection guide surface on the exterior of the resection guide's body. Other kerf spacers may be configured for use with resection guides in which the resection guide surface is in a slot of the resection guide's body (e.g. such as the resection guides shown in FIGS. 4-7.
[0086] In the particular example shown in FIG. 8 the kerf spacer 40 is configured for use with a single kerf width of a resection blade. Other kerf spacers may be configured to be adjustable to account for different kerf widths, such as by incorporating a mechanical adjustment mechanism into the kerf spacer or providing the kerf spacer with a series of shims or other spacer bodies for accounting for different kerf widths.Example Frame Supports
[0087] FIG. 9 shows an example of a frame support 12 usable with the bone reconstruction systems of FIGS. 1 and 2. The frame support 12 includes a distal bone fixation end 16 and an elongated member 52 extending from the distal end 16.
[0088] The distal bone fixation end 16 is configured to removably receive fixation elements (e.g. the fixation elements 18 shown in FIG. 10, which in this example are a pair of fixation pins). Converging apertures 54 in the distal bone fixation end 16 receive the fixation elements 18. The distal bone fixation end 16 also includes a concave bone referencing surface 56.
[0089] In some implementations the elongated member 52 of the frame support 12 may have a circular cross section or other cross section geometry that facilitates positioning the frame support 12 in a variety of rotational orientations relative to the external fixation frame. In some implementations the elongated member 52 may have a relatively uniform cross section along some or all of its length to facilitate positioning the frame support 12 in a variety of translational positions relative to the external fixation frame.Example Multi-Degree of Freedom Clamp
[0090] FIG. 11 shows an example of a multi-degree of freedom clamp 20 usable with the bone reconstruction systems of FIGS. 1 and 2. In this example the clamp 20 includes a first clamping unit 58 and a second clamping unit 60. In this example the clamp 20 includes a lock 62 configured to simultaneously lock and unlock both the first and second clamping units 58, 60. Unlocking the clamping units 58, 60 allows rotational and translational adjustment of the clamp relative to the elongated frame member(s), frame support(s), and / or resection guide(s) associated with the clamp. In this example unlocking the clamping units 58, 60 also allows rotational movement of the first clamping unit 58 relative to the second clamping unit 60.
[0091] In the example of FIG. 11 each clamping unit 58, 60 includes a clamp body 64 with an aperture 66 for receiving a frame member or an elongated member of a frame support or resection guide depending on the diameter of the aperture 66. Slots 68 extend from the apertures through the bodies 64, which facilitates the bodies 64 being compressed into a locked state and released into an unlocked state. In this example the lock 62 is a bolt 70 and nut 72 that can be used to compress the bodies 64 into the locked state and release the bodies 64 into the unlocked state. When in the unlocked state, the bodies 64 can rotate relative to one another about the bolt 70.
[0092] In the example of FIG. 11 at least one of the clamping bodies 64 includes a ridged washer 92 that faces and compresses against the opposing clamping body 64 (or another ridged washer) when the bodies 64 are compressed into a locked state. The ridges of the washer(s) 92 may help to further lock the rotational orientations of the bodies 64 relative to one another and resist rotational movement of the bodies 64 relative to one another when in the locked state. In another example, the ridged washer(s) 92 may be replaced with nonridged, rough-surfaced washer(s) (e.g. grit blasted washers) that may perform similar functions and offer similar benefits but also allow for infinite adjustment (as opposed to discrete adjustments due to the ridges of the washer). In still other examples, the bodies 64 themselves may have ridged or otherwise roughened surfaces that face the opposing body 64 that may perform similar functions and offer similar benefits.Example Bone Reconstruction Methods
[0093] FIGS. 12-21 and FIGS. 22-33 show two examples of bone reconstruction methods. In both examples, an external fixation frame is secured to a bone and a pair of resection guides are positioned and oriented to correspond to bone resections. In the example of FIGS. 12-21 the resection guides are used to guide both the bone resections and theallograft resections. In the example of FIGS. 22-23 the resection guides are only used to guide the allograft resections, with the resection guides being positioned and oriented to correspond to previously performed bone resections.FIGS. 12-21
[0094] FIGS. 12-21 illustrate some of the sequential steps of one example bone reconstruction method.
[0095] In FIGS. 12-13 an external fixation frame is secured to a bone. FIG. 12 shows a pair of frame supports being initially secured to a bone by fixation elements. In this example a pair of converging fixation pins are used to secure each frame support to the bone, with the frame supports being positioned proximal and distal to a segment of the bone to be resected. FIG. 13 shows an elongated frame member being secured to the frame supports by a pair of multi-degree of freedom clamps. The multi-degree of freedom clamps are locked to maintain the positions and orientations of the frame supports relative to the external fixation frame for the remainder of the procedure. The elongated frame member also includes another pair of multi-degree of freedom clamps for securing resection guides in a later step.
[0096] FIG. 14 shows indica placed on the bone to indicate the position and orientation of planned bone resections. The indicia is included on both the bone segment to be removed and the remaining bone segments to facilitate proper orientation of the allograft material relative to the remaining bone at a later step. This step is optional and may be based on surgeon preference in some implementations.
[0097] FIG. 15 shows the resection guides being secured to the external fixation frame by the additional pair of multi-degree of freedom clamps. The resection guides are positioned and oriented so that their resection guide surfaces are aligned with the planned positions and orientations of the bone resections. The positioning and orienting of the resection guides iscarried out with the pair of multi-degree of freedom clamps in unlocked conditions, allowing the resection guides to be rotated and translated relative to the external fixation frame until the desired positions and orientations of the guides is achieved. The resection guide clamps may then be locked to maintain the positions and orientations of the resection guides relative to the other components of the system for the remainder of the procedure.
[0098] FIG. 16 shows the bone after the resection guides have been used to resect and remove the bone segment. The fixation elements may be subsequently removed allowing removal of the bone resection system from the bone while leaving all of the multi-degree of freedom clamps locked thereby maintaining the positions and orientations of the frame supports and resection guides relative to one another and to the external fixation frame.
[0099] FIG. 17 shows the bone reconstruction system removed from the bone and moved to an allograft material, with the clamps remaining in a locked state such that the earlier positions and orientations of the frame supports and resection guides relative to one another and to the external fixation frame are maintained. Additional fixation elements are used to secure the bone reconstruction system to the allograft material.
[0100] The resection guides are subsequently used to guide resections in the allograft material, generating an allograft segment that has the same or substantially the same geometry and dimensions as the resected bone segment, as shown in FIG. 18. FIG. 19 shows the allograft material being implanted to replace the resected bone segment, substantially replicating the dimensions and geometry of the resected bone segment. As shown in FIG. 19, indicia on the bone and allograft material may be used to confirm that the allograft material is being positioned and oriented in the same manner as the removed bone. As shown in FIGS. 20-21 the external fixation frame and frame supports (still in their original positions and orientations) may be repositioned on the bone to confirm accuracy of the reconstruction.Additionally, the host bone may be provisionally held using the same frame supports to stabilize the bone / allograft construct during insertion of additional internal fixation (rods, screws, plates, etc.).FIGS. 22-33
[0101] FIGS. 22-23 illustrate some of the sequential steps of another example bone reconstruction method.
[0102] In FIG. 22 frame supports are secured to a bone using fixation elements. The frame supports are secured proximal and distal to a bone section for resection (for purposes of illustration a hypothetical bone material is shown in this example). As also shown in FIG. 22 an elongated frame element is secured to one of the frame supports using a multi-degree of freedom clamp.
[0103] FIGS. 23-24 show another elongated frame element secured to the other frame support by a multi-degree of freedom clamp and the two frame elements secured together by another multi-degree of freedom clamp. In this particular example, the use of multiple frame elements to form the external fixation frame may provide more freedom and options for component placement and alignment than may be possible with a single member frame like that used in FIGS. 12-21.
[0104] Although not shown in FIGS. 23-24, prior to connection of the elongated frame members, additional multi-degree of freedom clamps may be slid onto the frame members for future attachment of resection guides. The elongated frame members and clamps may be adjusted to ensure that there is adequate space for the resection guides at the locations of the planned resections.
[0105] FIG. 25 shows an alternative external fixation frame that uses three elongated frame members, which may provide further options for locating clamps for the resectionguides and otherwise provide more freedom and options for component placement and alignment. Note that some of the later figures show use of the two frame member system and other figures show use of the three frame member system in this hypothetical exemplary method. It should be appreciated that an actual bone reconstruction method would use the same frame configuration for the entire method.
[0106] After the external fixation frame and frame supports have been assembled and positioned and oriented in desired arrangements, the system may be removed from the bone as shown in FIG. 26 and the resections may be carried out while the system is removed from the bone. FIG. 1 shows the bone after resection. Note that in this example method the bone resections are performed freehand prior to attachment or alignment of any resection guides.
[0107] As shown in FIG. 28, after resection the frame assembly may be reattached to the bone segments at their original attachment points.
[0108] As shown in FIG. 29-30 the resection guides may next be aligned relative to the previously performed bone resections. As shown in FIG. 29, a kerf spacer may be used to account for the resection blade kerf when aligning the resection guides. After the resection guides are aligned relative to the bone resections, the multi-degree of freedom clamps securing the resection guides may be locked, fixing the positions and orientations of the resection guides relative to the other components of the bone reconstruction system.
[0109] The bone reconstruction system may next be removed from the bone and secured to the allograft material as shown in FIG. 31 again using fixation elements through the frame supports. A marker or other means of putting indica on the allograft material may be used to trace the resection line from the resection guides to the allograft material.
[0110] Next, resections may be performed on the allograft material based on the positions and orientations established by the resection guides. In some implementations theresections may be performed while the bone reconstruction system remains secured to the allograft material, with the resection guides guiding the resection blade. In other implementations the resections may be performed with the bone reconstruction system removed from the allograft material and the resections following the indicia formed on the allograft material based on the positions and orientations of the resection guides. FIG. 32 shows the resected allograft material having substantially the same dimensions and geometry of the resected bone segment.
[0111] Next the allograft may be implanted in the bone reconstructing the original geometry and dimensions of the bone. As shown in FIG. 33 the external fixation frame may be re-attached to the bone to check for proper alignment. In other examples (e.g. in the example of FIGS. 43-45 discussed further below), alignment can be checked using an alternative alignment device.Example Alternative Bone Reconstruction Systems
[0112] FIG. 34 shows an example of another alternative to the bone reconstruction systems described above. Similar to previous examples, the bone reconstruction system shown in FIG. 34 includes an external fixation frame 10 (specifically an elongated fame member 22), frame supports 12, and resection guides 14. In this example both of the resection guides 14 are connected to an auxiliary elongated frame member 74 that is removable as a unit from the rest of the bone reconstruction system. The resection guides 14 connect to the auxiliary elongated frame member 74 by multi-freedom clamps 20, and the auxiliary elongated frame member 74 is coupled to other frame members 22 of the system via additional multi-degree of freedom clamps 20.
[0113] In this example, the auxiliary elongated frame member 74 and associated resections guides 14 may be removed from the rest of the bone reconstruction system whilethe rest of the bone reconstruction system remains secured to the bone 100. The clamps 20 for the resection guides 14 may remain in a locked state when the auxiliary elongated frame member 74 is removed, such that the auxiliary elongated frame member 74 and associated resection guides can be secured to an allograft material or other reconstruction material for resection, while the rest of the system remains attached to the bone 100 and maintains alignment of the bone fragments.Example Alternative Multi-Degree of Freedom Clamp
[0114] FIG. 35 shows another example of a multi-degree of freedom clamp usable with the bone reconstruction systems and methods described herein. The multi-degree of freedom clamp shown in FIG. 35 has similar components and functionality as the multi-degree of freedom clamp shown in FIG. 11 except that in this example one of the clamping units has an open slot 76 that allows (when the clamp is in an unlocked state) convenient removal of an elongated member (e.g. of a resection guide or frame support) or elongated frame member from the clamping unit (as opposed to having to slide the clamp off of the end of the member or frame).Example Alternative Frame Supports
[0115] FIGS. 36-42 show additional examples of frame supports usable with the bone reconstruction systems and methods described herein. As shown in FIGS. 36-42 the distal reference surface and apertures in the support may vary in shape, configuration, and location. In some implementations, frame supports with different reference surfaces and apertures may be used depending on the geometry and other aspects of the anatomy to which the frame support will be secured. For instance, the frame support shown in FIG. 36 includes a t- shaped reference surface to add stability when attaching the frame to bones, such as a tibia or femur. The frame supports of FIGS. 37 and 38 may be useful when fixing to the proximaltibia to avoid interference with surrounding ligament and muscle attachments. The frame support of FIG. 39 may be useful on smaller diameter long bones such as the humerus.
[0116] FIGS. 40-41 show an example of a frame support including a connector 78 that detachably connects the frame support's distal end 16 to the frame support's elongate member 52. Use of frame supports with connectors 78 with the bone reconstruction systems and methods described herein allows easy and quick detachment of an elongated fixation frame and connected components as a single unit from the bony anatomy as well as easy and quick reattachment as a single unit to the bony anatomy. An example of this is further illustrated in context of the bone reconstruction method shown in FIGS. 46-56 and discussed in further detail below.
[0117] In the example of FIGS. 40-41 the connector 78 includes a socket 80 in the distal end 16 that receives and retains an end 82 of the elongate member 52. As shown in this example the socket 80 of the distal end 16 and the end 82 of the elongate member 52 may have a non-circular profile (in this particular example a hexagonal profile) that prevents rotational movement of the elongate member 52 relative to the distal end 16 when the two are connected. The non-circular profile of the socket 80 and the end 82 also result in the elongate member 52 only being connectable to the distal end 16 in a discrete number of rotational alignments (in the example of a hexagonal profile, six discrete rotational alignments).
[0118] The socket 80 of the distal end 16 and the end 82 of the elongate member 52 may have cavities 84 that receive magnets (not shown) configured to provide an attractive force to one another when the elongate member 52 and distal end 16 are connected to facilitate maintaining the connection and avoid unintentional disconnections. In other implementations the connection may be maintained in other fashions. For instance, a detentmechanism, a resilient locking mechanism (e.g. a resilient rib and groove arrangement), a friction fit arrangement, or other things may be used to maintain the connection between the elongate member 52 and distal end 16 to avoid unintentional disconnections.
[0119] FIG. 42 shows another example of a distal end 16 of a frame support that can be detached and reconnected from an elongate member. In this example the socket 80 has a square profile instead of a hexagonal profile. As noted above the hexagonal profile allows for six discrete rotational alignments when connecting the elongate member to the distal end. The square profile of the socket 80 in FIG. 42 allows for four discrete rotational alignments.Alternative Alignment Device - FIGS. 43-45
[0120] As discussed above, after implantation of the allograft, biomaterial, metal implant or other reconstruction implant, the external fixation frame and frame supports (still in their original positions and orientations) may be repositioned on the bone to confirm accuracy of the reconstruction, or the external fixation frame and frame supports may simply remain on the bony anatomy throughout the reconstruction procedure. In still other implementations and alternative alignment device may be used to confirm alignment after reconstruction.
[0121] FIGS. 43-45 show an alternative alignment device that may be used to confirm alignment after reconstruction of the bony anatomy. The alignment device in FIGS. 43-45 includes a pointer 86. In this example the pointer is an elongated, bent rod extending from an attachment end 88 to a reference end 90. Prior to resection, the pointer 86 may be secured to the bony anatomy with the attachment end 88 connected to the bony anatomy on one side of the planned resection(s) and the reference end 90 aligned with a reference associated with the bony anatomy on the other side of the planned resection(s). The pointer 86 may be secured to the bony anatomy in a manner that allows it to be removed from the bony anatomyand reattached to the bony anatomy in the exact same position and orientation as it was in before it was removed. In some implementations the detachable frame supports of FIGS. 40- 41 may be used for this purpose.
[0122] FIGS. 44-45 show an example of a distal femoral reconstruction with a planned resection 108. Prior to resection, the pointer 86 may be attached at its attachment end 88 to the proximal femur using fixation elements 18, frame support 12, and multi-degree of freedom clamp 20. Frame support 12 may be the same frame support 12 used for the external fixation frame or may be specifically used just for the pointer 86.
[0123] The pointer 86 may be clamped in multi-degree of freedom clamp 20 such that the reference end 90 is aligned with an alignment point 110 (see FIG. 45). Once aligned, the pointer 86 may be removed (using the detachable frame support of FIG. 40-41 for example) and replaced to check alignment of the bony anatomy.Example Alternative Bone Reconstruction Method - FIGS. 46-56
[0124] FIGS. 46-56 show another example of a bone reconstruction method. In the example methods of FIGS. 12-21 and FIGS. 22-33 the resection guides 14 are physically secured to the elongated frame members 22 as part of the method. In the example method of FIGS. 46-56 the resection guides 14 are not physically secured to the elongated frame members 22. The bone reconstruction method of FIGS. 46-56 may use the same or similar components to those described in other examples in this patent, or may use other components.
[0125] As shown in FIG. 46, frame supports 12 may be secured at two locations on the bony anatomy relative to a bone portion 104 for reconstruction. As in earlier examples, the frame supports 12 include distal bone fixation ends 16 where the external fixation system may be fixed to the bony anatomy by fixation elements 18, which in this instance are bi-cortica Iwire pins. In other implementations the frame supports and fixation elements may be configured for uni-cortical fixation. As in earlier examples, the frame supports 12 in this example are secured to locations on the bony anatomy with the bone portion 104 for reconstruction located between the two locations on which the frame supports 12 are secured.
[0126] As shown in FIG. 47, an elongated fixation frame 22 may be secured to the frame supports 12 such that the elongated fixation frame 22 spans across the bone portion 104 for reconstruction. In this example a single elongated fixation frame 22 is used, although, as shown in earlier examples, multiple elongated fixation frames 22 may be used.
[0127] As in earlier examples, the frame supports 12 include elongated members 52 extending from the distal ends 16, with the frame supports 12 secured to the elongated fixation frame 22 by clamping the elongated members 52 to the elongated fixation frame 22. More specifically, in the example shown, multi-degree of freedom clamps 20 are used to clamp the elongated members 52 of the frame supports 12 to the elongated fixation frame 22.
[0128] In this example, the frame supports 12 include a connector 78 detachably connecting the distal end 16 from a proximal end (e.g. the elongated member 52) of the frame support. The frame supports 12 in this example may be the same as or similar to the frame supports 12 shown in FIGS. 40-41 and discussed above or may be configured differently. As shown in FIG. 48, after the elongated fixation frame 22 has been secured to the frame supports 12, the elongated fixation frame 22, the multi-degree of freedom clamps 20, and the proximal ends of the frame supports 12 may be detached as a single unit from the distal ends 16 of the frame supports 12. In at least some implementations, this single unit may function as a reference tool for recreating and confirming proper spatial positioning and orientation ofthe bone segments of the bony anatomy on either side of the bone portion 104 for reconstruction, even after resections have been performed on the bony anatomy. This is shown and discussed further below.
[0129] FIG. 49 shows the bony anatomy and remaining distal ends 16 of the elongated frame supports 12 after detachment of the elongated fixation frame 22 and other connected components. With these components detached, the operating window may be relatively unobstructed for subsequent steps of the bone reconstruction method. In other examples the elongated fixation frame 22 and other connected components are not disconnected and remain attached in later steps of the procedure. In other examples the elongated fixation frame 22 and other connected components may remain attached to the bony anatomy during the reconstruction procedure.
[0130] FIGS. 50-52 show that, with parts of the frame supports 12 remaining secured to the bony anatomy (specifically, with the distal ends 16 of the frame supports 12 remaining secured to the bony anatomy), one or more resections may be performed (specifically, in this example, two resections) to separate the bone portion 104 for reconstruction from the bony anatomy.
[0131] In this particular example, resection guides 14 are secured to the bony anatomy between the frame supports 12 (or, more specifically in this example, between the remaining distal ends 16 of the frame supports 12). The resection guides 14 may be the same or similar to resection guides described in earlier examples, and may be secured to the bony anatomy using the same or similar techniques described earlier. In other implementations, the resection guides 14 are not necessarily the same or similar to those described above.
[0132] As shown in FIG. 51, the resection guides 14 may be secured to one another such that a relative position and relative orientation of the resection guides 14 to one anotheris fixed. More specifically, in this particular example, multi-degree of freedom clamps 20 may be used to secure the resection guides 14 to an auxiliary fixation frame 74, thereby fixing the relative position and relative orientation of the resection guides 14 to one another.
[0133] As shown in FIG. 52, with the resection guides 14 secured to the bony anatomy and fixed in relative position and relative orientation with respect to one another, and with the distal ends 16 of the frame supports 12 remaining secured to the bony anatomy, the resection guides 14 may be used to guide a cutterto perform resections on the bony anatomy thereby removing bone portion 104. After the resections, the resection guides 14 and associated auxiliary fixation frame 74 and multi-degree of freedom clamps 20 may be removed as a single unit (e.g. by removing fixation elements 18).
[0134] As shown in FIG. 53, after resection of the bone portion 104, the elongated fixation frame 22 and connected components (in this example, the multi-degree of freedom clamps 20 and the proximal portions of the frame supports 12) may be re-attached as a single unit to the distal ends 16 of the frame supports 12. By doing so, even though the bone portion 104 has been removed from the bony anatomy, the remining portions of the bony anatomy may be maintained in the same relative positions and orientations to one another as they were in before the resections and removal of the bone portion 104.
[0135] As shown in FIGS. 54 and 55, while the resection guides 14 remain secured to the auxiliary fixation frame 74, the resection guides 14 may be used to guide resections of a bone reconstruction implant 106. More specifically, in this particular example, with the multidegree of freedom claims 20 remaining in a locked state such that the earlier positions and orientations of resection guides 14 relative to one another are maintained, the resection guides 14 may be secured to an allograft material and subsequently be used to guideresections in the allograft material, generating an allograft segment that has the same or substantially the same geometry and dimensions as the resected bone portion 104.
[0136] As shown in FIG. 56, the bone reconstruction implant (e.g. the resected allograft material from FIG. 55) may be implanted into the bony anatomy while the elongated frame 22 and associated components are attached to the distal ends 16 of the frame supports 12 attached to the bony anatomy, thereby facilitating implantation of the bone reconstruction implant 106 in a manner that preserves the original relative positioning and orienting of the remaining portions of the bony anatomy. In other implementations the goal of the bone reconstruction method may not necessarily be to exactly preserve the original relative positioning and orienting of the remaining portions of the bony anatomy. As just one illustrative example, it may be desired as part of the method to lengthen an overall length of one of the bones of the anatomy by a controlled and pre-planned amount. In such instances, the bone reconstruction system may include mechanisms (not shown in the Figures) for adjusting one or more components of the system in a controlled fashion.Example Alternative Bone Reconstruction Method - FIGS. 57-59
[0137] FIGS. 57-59 illustrate another example of a bone reconstruction method that is similar to the method of FIGS. 46-56 except that in this instance the external fixation frame 10 includes two elongated frame members 22 that span across a joint of the bony anatomy (in this specific example, a knee joint) and in which the bone portion 104 for reconstruction is an entire distal portion of one of the bones (in this specific example, the distal femur), such that only a single resection is necessary.Conclusion
[0138] The above description is provided by way of example only. Additions, deletions, modifications, substitutions, and other changes may be made to the example systems andmethods described above without departing from the scope or spirit of the claimed inventions.
Claims
Claims:
1. A bone reconstruction method comprising:(a) securing a first frame support to a first location on a bony anatomy, the bony anatomy comprising a bone portion for reconstruction;(b) securing a second frame support to a second location on the bony anatomy, wherein the bone portion for reconstruction is located between the first and second locations;(c) securing an elongated fixation frame to the first and second frame supports such that the elongated fixation frame spans across the bone portion for reconstruction;(d) with at least part of the first frame support and part of the second frame support remaining secured to the first and second locations, performing at least one resection to separate the bone portion for reconstruction from the bony anatomy; and(e) implanting a bone reconstruction implant, wherein the elongated frame is either still attached or is re-attached to the first and second frame supports secured at the first and second locations after the bone reconstruction implant is implanted.
2. The bone reconstruction method of claim 1 further comprising securing a resection guide to the bony anatomy between the first and second frame supports; and wherein performing the at least one resection comprises using the resection guide to guide a cutter to perform the at least one resection.
3. The bone reconstruction method of claim 2 further comprising: securing a second resection guide to the bony anatomy between the first and second frame supports; andusing the second resection guide to guide the cutter to perform a second resection.
4. The bone reconstruction method of claim 3 further comprising securing the first resection guide to the second resection guide such that a relative position and relative orientation of the first resection guide to the second resection guide is fixed.
5. The bone reconstruction method of claim 4 wherein securing the first resection guide to the second resection guide comprises using multi-degree of freedom clamps to secure the first and second resection guides to an auxiliary fixation frame.
6. The bone reconstruction method of claim 5 further comprising, while the first and second resection guides are secured to the auxiliary fixation frame, using the first and second resection guides to guide resections of the bone reconstruction implant.
7. The bone reconstruction method of claim 1: wherein securing the first frame support to the first location on the bony anatomy comprises securing a first distal bone fixation end of the first frame support to the first location; and wherein securing the second frame support to the second location on the bony anatomy comprises securing a second distal bone fixation end on the second frame support to the second location.
8. The bone reconstruction method of claim 7:wherein the first frame support further comprises a first elongate member extending from the first distal end; wherein the second frame support further comprises a second elongate member extending from the second distal end; and wherein securing the elongated fixation frame to the first and second frame supports comprises clamping the first and second elongate frame members to the elongated fixation frame.
9. The bone reconstruction method of claim 8 wherein multi-degree of freedom clamps are used to clamp the first and second elongate frame members to the elongated fixation frame.
10. The bone reconstruction method of claim 8 wherein the first frame support comprises a first connector detachably connecting the first distal end from a first proximal end of the first frame support; and wherein the second frame support comprises a second connector detachably connecting the second distal end from a second proximal end of the second frame support.
11. The bone reconstruction method of claim 10 further comprising: after securing the elongated fixation frame to the first and second frame supports, detaching as a single unit the elongated fixation frame, the first proximal end of the first frame support, and the second proximal end of the second frame support from the first and second distal ends of the first and second frame supports; andsubsequently re-attaching as the single unit the elongated fixation frame, the first proximal end of the first frame support, and the second proximal end of the second frame support to the first and second distal ends of the first and second frame supports.
12. The bone reconstruction method of claim 11 wherein the at least one resection is performed with the first and second distal ends of the first and second frame supports secured to the first and second locations of the bony anatomy and the first and second proximal ends disconnected from the first and second distal ends of the first and second frame supports.
13. A bone reconstruction system comprising:(a) a first frame support comprising a first distal bone fixation end configured to receive a first fastener, the first distal bone fixation end comprising a first bone referencing surface;(b) a second frame support comprising a second distal bone fixation end configured to receive a second fastener, the second distal bone fixation end comprising a second bone referencing surface;(c) an elongated fixation frame;(d) a first multi-degree of freedom connector configured to connect the first frame support to the elongated fixation frame with multiple degrees of freedom; and(e) a second multi-degree of freedom connector configured to connect the second frame support to the elongated fixation frame with multiple degrees of freedom.
14. The bone reconstruction system of claim 13wherein the first frame support further comprises a first elongate member extending from the first distal bone fixation end, the first elongate member detachably connected to the first distal bone fixation end; and wherein the second frame support further comprises a second elongate member extending from the second distal bone fixation end, the second elongate member detachably connected to the second distal bone fixation end.
15. The bone reconstruction system of claim 14 wherein the first and second frame supports comprise pull out connections detachably connecting the first and second elongate members to the first and second distal bone fixation ends.
16. The bone reconstruction system of claim 15 wherein the pull out connection of the first frame support comprises a different shape from the pull out connection of the second frame support.
17. The bone reconstruction system of claim 13 wherein the first and second bone referencing surfaces are concave surfaces.
18. The bone reconstruction system of claim 13 further comprising a resection guide positionable between the first and second frame supports, the resection guide comprising a resection guide surface for guiding a resection.
19. The bone reconstruction system of claim 18 further comprising:a kerf spacer comprising a bone resection referencing surface and an allograft resection guide surface; and a resection cutter comprising a kerf width; wherein the bone resection referencing surface is spaced from the allograft resection guide surface by the kerf width.
20. The bone reconstruction system of claim 13: wherein the first multi-degree of freedom connector comprises an unlocked state wherein the elongated fixation frame is rotatable and translatable relative to the first frame support and a locked state wherein the elongated fixation frame is fixed relative to the first frame support; and wherein the second multi-degree of freedom connector comprises an unlocked state wherein the elongated fixation frame is rotatable and translatable relative to the second frame support and a locked state wherein the elongated fixation frame is fixed relative to the second frame support.
21. The bone reconstruction system of claim 13 further comprising an alignment pointer detachably connectable to one of the first and second frame supports.
22. The bone reconstruction system of claim 13 further comprising a computer assisted surgery fiducial detachably connectable to one of the first frame support, second frame support, or elongated fixation frame.
23. A bone reconstruction system comprising:(a) an external fixation frame;(b) a first frame support connected to the external fixation frame and comprising a first distal bone fixation end;(c) a second frame support connected to the external fixation frame and comprising a second distal bone fixation end;(d) a first resection guide connected to the external fixation frame between the first and second frame supports, the first resection guide comprising a first resection guide surface for guiding a first resection; and(e) a second resection guide connected to the external fixation frame between the first and second frame supports, the second resection comprising a second resection guide surface for guiding a second resection.
24. The bone reconstruction system of claim 23 wherein:(a) the first resection guide comprises an unlocked state wherein the first resection guide is translatable and rotatable relative to the external fixation frame and a locked state wherein a position and an orientation of the first resection guide relative to the external fixation frame is fixed; and(b) the second resection guide comprises an unlocked state wherein the second resection guide is translatable and rotatable relative to the external fixation frame and a locked state wherein a position and an orientation of the second resection guide relative to the external fixation frame is fixed.
25. The bone reconstruction system of claim 24 wherein:(a) the first frame support comprises an unlocked state wherein the first frame support is translatable and rotatable relative to the external fixation frame and a locked state wherein a position and an orientation of the first frame support relative to the external fixation frame is fixed; and(b) the second frame support comprises an unlocked state wherein the second frame support is translatable and rotatable relative to the external fixation frame and a locked state wherein a position and an orientation of the second frame support relative to the external fixation frame is fixed.
26. The bone reconstruction system of claim 25 wherein the first and second resection guides and the first and second frame supports each are connected to the external fixation frame by a multi-degree of freedom clamp.
27. The bone reconstruction system of claim 26 wherein the multi-degree of freedom clamps are lockable and unlockable.
28. The bone reconstruction system of claim 26 wherein at least one of the multi-degree of freedom clamps includes a first clamping unit and a second clamping unit.
29. The bone reconstruction system of claim 28 wherein:(a) unlocking of the first clamping unit allows rotational and translational adjustment of the multi-degree of freedom clamp relative to the external fixation frame; and(b) unlocking of the second clamping unit allows rotation and translation adjustment of the frame support or resection guide connected to the multi-degree of freedom clamp.
30. The bone reconstruction system of claim 29 wherein the multi-degree of freedom clamps each comprise a lock configured to simultaneously unlock both the first and second clamping units.
31. The bone reconstruction system of claim 30 wherein unlocking the lock allows rotational movement of the first clamping unit relative to the second clamping unit.
32. The bone reconstruction system of claim 25 wherein the distal bone fixation ends of the first and second frame supports are each configured to removably receive one or more fixation elements.
33. The bone reconstruction system of claim 32 wherein the distal bone fixation ends of the first and second frame supports each comprises one or more apertures for receiving the fixation elements.
34. The bone reconstruction system of claim 25 wherein the distal bone fixation ends of the first and second frame supports each comprises a concave bone referencing surface.
35. The bone reconstruction system of claim 25 wherein the first and second resection guide surfaces of the first and second resection guides comprise planar exterior surfaces on bodies of the first and second resection guides.
36. The bone reconstruction system of claim 25 wherein the first and second resection guide surfaces of the first and second resection guides comprise first and second resection guide slots extending through the first and second resection guides.
37. The bone reconstruction system of claim 36 wherein the first and second resection guides each comprise a concave bone facing surface.
38. The bone reconstruction system of claim 36 wherein at least one of the first and second resection guides comprises an additional parallel resection guide slot.
39. The bone reconstruction system of claim 25 further comprising:(a) a kerf spacer comprising a bone resection referencing surface and an allograft resection guide surface; and(b) a resection cutter comprising a kerf width;(c) wherein the bone resection referencing surface is spaced from the allograft resection guide surface by the kerf width.
40. The bone reconstruction system of claim 25 wherein the external fixation frame comprises an elongated frame member.
41. The bone reconstruction system of claim 25 wherein the external fixation frame comprises at least two elongated frame members connected together by an adjustable connector.
42. The bone reconstruction system of claim 41 wherein the adjustable connector comprises an unlocked state wherein the elongated frame members are rotatable and translatable relative to one another and a locked state wherein the elongated frame members are fixed relative to one another.
43. A bone reconstruction method comprising:(a) securing an external fixation frame to a bone;(b) positioning and orienting a first resection guide to correspond to a first bone resection;(c) after positioning and orienting the first resection guide to correspond to the first bone resection, locking the position and orientation of the first resection guide relative to the external fixation frame;(d) positioning and orienting a second resection guide to correspond to a second bone resection in the bone;(e) after positioning and orienting the second resection guide to correspond to the second bone resection, locking the position and orientation of the second resection guide relative to the external fixation frame;(f) with the positions and orientations of the first and second resection guides locked, removing the external fixation frame from the bone and securing the external fixation frame to an allograft or a biomaterial;(g) performing a first and a second resection on the allograft or the biomaterial based on the locked positions and orientations of the first and second resection guides;(h) implanting the allograft or the biomaterial in the bone.
44. The method of claim 43 wherein securing the external fixation frame to the bone comprises securing first and second frame supports to the bone and securing the external fixation frame to the first and second frame supports.
45. The method of claim 44 wherein securing the external fixation frame to the first and second frame supports comprises securing a first elongated frame member to the first frame support, securing a second elongated frame member to the second frame support, and securing the first and second elongated frame members together.
46. The method of claim 44 wherein securing first and second frame supports to the bone comprises securing the first and second frame supports to the bone at locations that are proximal and distal to a resection segment of the bone.
47. The method of claim 44 wherein positioning and orienting the first and second resection guides to correspond to the first and second bone resections comprises positioning and orienting the first and second resection guides to correspond to planned positions and orientations for the first and second bone resections.
48. The method of claim 44 wherein positioning and orienting the first and second resection guides to correspond to the first and second bone resections comprises positioning and orienting the first and second resection guides to correspond to previously performed first and second bone resections.
49. The method of claim 44 wherein positioning and orienting the first and second resection guides to correspond to the first and second bone resections comprises:(a) positioning and orienting the first resection guide using a kerf spacer such that a planar resection guide surface of the first resection guide is positioned and oriented parallel to the first bone resection and spaced from the first bone resection by a kerf width of a resection cutter; and(b) positioning and orienting the second resection guide using the kerf spacer such that a planar resection guide surface of the second resection guide is positioned and oriented parallel to the second bone resection and spaced from the second bone resection by the kerf width of the resection cutter.
50. The method of claim 43 further comprising after implanting the allograft or the biomaterial in the bone re-attaching the external fixation frame to the bone to check alignment.
51. The method of claim 43 wherein the external fixation frame comprises an elongated frame member and an auxiliary elongated frame member, wherein the first and second resections guides are secured to the auxiliary elongated frame member, wherein the auxiliary elongated frame member is secured to the elongated frame member, wherein removing the external fixation frame from the bone comprises removing the auxiliary elongated frame member and the first and section resection guides from the elongated frame member as a locked unit, and wherein securing the external fixation frame to the allograft or biomaterial comprises securing the auxiliary elongated frame member and the first and second resection guides to the allograft as a locked unit.
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