Double-sided dome osteotomy reamer

Abstract

The improved dual-sided dome osteotomy reamer is intended for the contouring the bone portions for various orthopedic surgical procedures. The dome osteotomy reamer comprises a generally or substantially hemispherical form and is adapted for attachment to a reamer shaft and / or a reamer adapter in order to be driven in rotation about a cutting axis. The dome osteotomy reamer adequately contours the bone portions to create a polyaxial junction or a convex-concave junction for stability, multiaxial alignment and efficiency.

Description

DOUBLE-SIDED DOME OSTEOTOMY REAMERCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of Application No. 19 / 046,394, filed February 5, 2025, entitled “Double-Sided Dome Osteotomy Reamer,” which claims the benefit of U.S. Provisional Application No. 63 / 721,914 entitled “Double-Sided Dome Osteotomy Reamer” filed on November 18, 2024, the disclosures of which are incorporated by reference herein in its entireties.

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 721 ,914 entitled “Double-Sided Dome Osteotomy Reamer” filed on November 18, 2024, the disclosure of which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0003] The invention relates to methods, devices, and systems for an improved instrument used for modifying bone surfaces during orthopedic surgery. More specifically, the invention relates to methods, devices and systems for an improved reamer instrument to prepare bone surfaces for a variety of orthopedic surgical procedures.BACKGROUND OF THE INVENTION

[0004] Multi-planar bone deformities are common and need proper surgical correction in patients. Multiplanar bone deformities require extensive surgical planning and precision execution. Surgeons are limited in available tools and techniques to adequately address complex multi-plane deformity corrections.

[0005] The current technique for a true dome osteotomy requires multiple sets of instruments that are not designed for this purpose and requires an excessive number of surgical steps to achieve the result. Current technique requires obtaining humeral or femoral head reverse reamers and / or acetabular reamers to be used for a different or non-intended surgical procedure. Acetabular (and some reverse reamers) do not have a self-centering feature, which opens the possibility for off-axis reaming of one or both surfaces. This could lead to a bone gap or translation if an intramedullary device is then introduced for fixation causing malunions or non-unions. If the optimum combination of acetabular and reverse reamers is not chosen, there could be poor fit between the two shaped bone ends. This results in significant soft tissue stripping to perform the current technique. Understanding and planning for a multi-planar correction requires expertise, and slight changes in the plan or execution could lead to inabilityto properly achieve the correction or desired anatomical alignment and / or lead to future complications such as mal-unions or non-unions.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0006] FIGS. 1A-1C depicts various plan views of a first embodiment of a dome reamer assembly;

[0007] FIG. 2A depicts an exploded isometric view of the first embodiment dome reamer assembly of FIGS. 1A-1C;

[0008] FIG. 2B depicts an exploded isometric view of a second embodiment dome reamer assembly;

[0009] FIG. 2C depicts an exploded isometric view of a third embodiment dome reamer assembly;

[0010] FIGS. 3A-3D depicts various plan views of an embodiment of a reamer adapter;

[0011] FIGS. 4A-4D depict various plan views of a first embodiment of a dome reamer;

[0012] FIGS. 4E-4F depict a cross-section and magnified cross-section of the dome reamer of FIGS. 4A-4D;

[0013] FIG. 4G depicts a cross-sectional view of different embodiments of the positions and orientations of the cutting elements;

[0014] FIGS. 5A-5C depict isometric views of different shape embodiments of a dome reamer;

[0015] FIGS. 6A-6E depict different plan views of one embodiment of a method of using the dome reamer or dome reamer assembly;

[0016] FIGS. 7A-7B depicts a flowchart of the method of using the dome reamer or dome reamer assembly;

[0017] FIGS. 8A-8E depicts various plan views of a second embodiment of a dome reamer;

[0018] FIGS. 9A-9E depicts top and bottom views of one embodiment of a method of a reamer shaft engagement to the dome reamer;

[0019] FIG. 10 depicts a side view of a third embodiment of a dome reamer;

[0020] FIG. 11 depicts a side view of a fourth embodiment of a dome reamer;

[0021] FIG. 12 depicts an isometric view of a fifth embodiment of a dome reamer;

[0022] FIGS. 13A-13D depicts various plan views of an embodiment of a reamer shaft; and

[0023] FIG. 13E depicts a cross-sectional view of the reamer shaft of FIGS. 13A-13D.BRIEF SUMMARY OF THE INVENTION

[0024] In one embodiment, the dome osteotomy reamer comprises a hollow body, the hollow body comprises a central axis, an outer surface, an inner surface, a plurality of openings, and a connection opening, each of the plurality of openings spaced apart and extend from the outer surface through the inner surface; and a first plurality of cutting elements, the first plurality of cutting elements disposed onto the outer surface of the hollow body adjacent to the plurality of openings at a first position and oriented in a first direction; and a second plurality of cutting elements, the second plurality of cutting members disposed onto the inner surface of the hollow body adjacent to the plurality of openings at a second position and oriented in a second direction.

[0025] In another embodiment, the method of using the dome osteotomy bone reamer comprises the steps of: completing the desired osteotomy to create a first and second portions of a bone; creating a first passageway into a first portion of the bone; aligning the first and second portions of the bone; creating a second passageway into the second portion of the bone; and contouring a portion of the of the first portion of the bone and a portion of the second portion of the bone using the dome osteotomy reamer to create a polyaxial joint. The method may further comprise the steps of: restoring anatomic alignment; and fixating the first and second bone portions of the bone.

[0026] In one embodiment, the step of contouring further comprises the steps of: positioning the dome osteotomy reamer between the first and second portions of the bone; securing the dome osteotomy bone reamer to a portion of the reamer shaft; and activating the dome osteotomy reamer to create a first contoured bone end from a first portion of the bone and a second contoured bone end from a second portion of the bone. In another embodiment, the step of contouring comprises the steps of: engaging the dome osteotomy bone reamer with a portion of the reamer shaft, the dome osteotomy reamer positioned between the first and second portions of the bone; applying a first force against a first resected surface of the first portion of the bone and activating the dome osteotomy reamer in a first cutting direction to create a first contoured bone end of the first portion of the bone; and applying a second force against a second resected surface of the second portion of the bone and rotating the dome osteotomy reamer in a second cutting direction to create a second contoured bone end of the second portion of the bone.DETAILED DESCRIPTION OF THE INVENTION

[0027] The following detailed description is of the best currently contemplated modes of carrying out the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims.

[0028] The dome osteotomy assembly may be used in various surgical applications. Such surgical applications include, but not limited to orthopedic conditions where bone defects are reconstructed, allowing for matching surfaces to be mated, such as allografts or autografts in segmental defects. The dome osteotomy reamer can also be employed at the start of the transport phase of distraction osteogenesis bone transport, as the bone surfaces are matched prior to docking occurs, lessening the bone gaps which can be encountered during the docking phase of transport. Also, the dome osteotomy reamer may be used with malunions or nonunions, where the bone portions can be re-shaped and re-aligned into compressible dome surfaces to allow compression without gaps.

[0029] There exists a need for the improved double-sided dome osteotomy reamer to be used in osteotomy surgical procedures. The improved double-side dome osteotomy reamer has many advantages, including, but not limited to (1) allowing for correction with a forgiving, compressible set of surfaces without significant bone gaps or defects for early or immediate weight bearing; (2) allowing for correction in different planes; (3) creating a successful, arcuate surfaces with mating “cup;” (4) having an inherent stability of the mated bone portions due to the bone portions mating surface uniformity; (5) more accurate alignment between bone portions; (6) minimal surgical planning compared to focal dome osteotomy or mathematically directed single-cut osteotomy; (7) reduced number of tools used; and (8) more efficient surgical procedure.

[0030] FIGS. 1A-1C and 2A depict various plan views of a first embodiment of a dome osteotomy reamer assembly 2. The dome osteotomy reamer assembly 2 comprises a dome reamer 6 and a reamer adapter 4. The dome osteotomy reamer 6 is removably coupled to the reamer adapter 4. The dome osteotomy reamer 6 is a surgical instrument with dual-sided cutting elements 34, 44 that can cut a concave surface on one end of a first portion of a bone while cutting a matching convex surface on the adjacent portion or second portion of the bone. The activation of the rotational force and a push-and-pull action against one or more portions of the bone to create a polyaxial joint. The polyaxial joint includes a concave surface on a first bone portion and a matching convex surface on a second bone portion that can correct precise combinations of angular and rotational deformities in different planes. The dome osteotomyreamer 6 is significantly less invasive than current instruments. The current process requires a large exposure to deliver each bone end. Standard individual concave acetabular reamers and convex humeral / femoral head reamers require a direct approach to each bone end, whereas the dome osteotomy reamer 6 can be slipped into an osteotomy site with less soft tissue and periosteal stripping, then engaged into a reamer shaft that cuts each bone surface without the need to fully deliver the bone ends.

[0031] The reamer adapter 4 is a dual-purpose tool once it is removably coupled to the dome osteotomy reamer 6. The first purpose of the reamer adapter 4 clamps, secures or grips a workpiece through its center with a clamping pressure to keep it immobile and self-centered. The second purpose is to lock the reamer adapter 4 to the dome osteotomy reamer 6 by inserting a workpiece through the center to expand the segmented sleeve arms outwardly to apply a radial force preventing the reamer adapter 4 from loosening. The workpieces may include tools, drill bits, reamers or guide wires. The reamer adapter 4 may be further removably coupled to an existing rotary drill and / or the rotary drill shaft.

[0032] FIG. 2B-2C and 13A-13E depicts a second and third embodiment of a dome osteotomy reamer assembly 8, 132. The dome osteotomy reamer assembly 8, 132 comprises a dome osteotomy reamer 6, 96, 126, 128, 130 and a reamer shaft 10a, 10b. The reamer shaft 10a, 10b is also a readily available, dual-purpose tool that is known in the art. It may be provided by Orthopedic Implant Company (OIC)(Reno, NV), Intramedullary Flexible Reaming System by Avalign Technologies (Rosemont, IL), and / or Synream® of DepuySynthes by Johnson & Johnson MedTech (West Chester, PA). It includes an elongated shaft that may be directly coupled to an existing rotary drill at one end (second end) and a reamer bit (not shown) at the opposing end (first end). The rotary drill may comprise a manual or powered rotary drill.

[0033] The reamer shaft 10a, 10b may comprise a rigid or flexible reamer shaft. The reamer shaft 10a, 10b may comprise a first end and a second end. The first end may comprise an engagement end, the engagement end may engage or contact a reamer bit and / or the dome osteotomy reamer 6, 96, 126, 128, 130 as shown in FIGS. 2B and / or 13A-13E. The second end may connect or engage with the rotary drill. The reamer shaft 10a, 10b may comprise a passageway that extends from the first end through to the second end. The passageway is sized and configured to receive a portion of a guidewire.

[0034] FIGS. 3A-3D depict different plan views of a reamer adapter 4. The reamer adapter 4 comprises a first end 12, a second end 14, a first surface 26 and a second surface 28, a segmented sleeve 22, a connector body 16 and a lumen 30. The lumen 30 extends from the second surface 28 through the channel surface 25. The lumen is sized and configured toreceive a surgical workpiece. The surgical workpiece may include drill bits, reamers, guidewires and / or any combination thereof. The segmented sleeve 22 comprises a plurality of segments 22a, 22b, 22c, 22d a coupling band 20. The plurality of segments 22a, 22b, 22c, 22d are arranged spaced apart from each other in a radial pattern. The segmented sleeve 22 may comprise a taper. The coupling band 20 is positioned between the first surface 26 and the second surface. The coupling band 20 comprises a band cross-sectional shape, the band cross-sectional shape may comprise a circle and / or a polygon. In one exemplary embodiment, the band cross-sectional shape comprises a hexagonal cross-sectional shape. The coupling band 20 is sized and configured to engage with the adapter opening 36of the dome osteotomy reamer 6. The coupling band 20 is sized and configured to mate with the adapter opening 36 of the dome osteotomy reamer 6. The segmented sleeve 22 is positioned near, adjacent and / or within the second end 14. The coupling band 20 may also further comprise segmented band sections.

[0035] The connector body 16 comprises collar 18 and a channel 24. The channel 24 extends from a first surface 26 towards the second surface 28. The channel 24 is sized and configured to receive a matching “tail” from an existing rotary drill shaft that is known in the art to form a dovetailed joint. However, other connecting mechanisms may be utilized that are known in the art for coupling and quick release between two or more pieces. The channel 24 comprises a channel surface 25. The connector body comprises a connector body diameter and the collar 18 comprises a collar diameter. The collar diameter of the collar 18 is greater than the connector body diameter. Furthermore, the collar diameter of the collar 18 is greater than a segmented sleeve 22 diameter and / or a coupling band diameter. The increased diameter of the collar 18 allows the reamer adapter 4 to be inserted through the adapter opening 36 of the dome osteotomy reamer 6 and provide a depth stop or a positive stop to prevent the reamer adapter 4 from being inserted through the adapter opening 36 past a desired length or depth.

[0036] FIGS. 4A-4G, 8A-8F and 10-12 depict various plan views of a first, second, third, fourth and fifth embodiment of a dome osteotomy reamer 6, 96, 126, 128, 130. The dome osteotomy reamer 6, 96, 126, 128, 130 comprises a hollow body 31 that includes an outer surface 32, an inner surface 42, a connection opening 36, a plurality of holes 39, a first plurality of cutting elements 34 and a second plurality of cutting elements 44. The hollow body 31 may further include a platform 37 having a top surface 38. The hollow body 31 may further include a hollow body shape and / or a hollow body wall thickness 54. The hollow body 31 may further include a connection slot 98. The hollow body 31 may further include an outer rim 40. The hollow body may further include a tool opening 106.

[0037] The dome osteotomy reamer 6, 96, 126, 128, 130 comprises a plurality of holes 39. The plurality of holes 39 are disposed onto the hollow body 31 of the dome osteotomy reamer 6, 96, 126, 128, 130. More specifically, the plurality of holes 39 are disposed circumferentially or radially around the hollow body 31. The plurality of holes 39 are spaced apart from each other. At least a portion of the plurality of holes 39 may comprise a sharpened edge. The plurality of holes 39 extend from the outer surface 32 through the inner surface 42 of the hollow body 31. The plurality of holes 39 allows the small pieces of cut bone and cartilage to pass through the plurality of holes 39 towards the inner surface 42 and / or outwards towards the outer surface 32 of the hollow body 31 and prevent collection at the surgical site.

[0038] The dome osteotomy reamer 6, 96, 126, 128, 130 comprises a first plurality of cutting elements 34. The first plurality of cutting elements 34 are disposed circumferentially or radially around the hollow body 31 onto the outer surface 32 of the hollow body 31. The first plurality of cutting elements may be positioned adjacent, on top of and / or over a portion of the plurality of holes 39. The first plurality of cutting elements 34 are positioned in a first cutting direction or first cutting orientation and a first position.

[0039] The dome osteotomy reamer 6, 96, 126, 128, 130 comprises a second plurality of cutting elements 44. The second plurality of cutting elements 44 are disposed circumferentially or radially around the hollow body 31 onto an inner surface 42 of the hollow body 31. The second plurality of cutting elements 44 may be positioned adjacent to, on top of and / or over a portion of the plurality of holes 39 (as shown in FIG. 4G). The second plurality of cutting elements 44 are positioned in a second cutting direction or second cutting orientation, and a second position.

[0040] The first cutting direction is different than the second cutting direction.Alternatively, the first cutting direction is the same as the second cutting direction. The first plurality of cutting elements 34 and the second plurality 44 comprise cutting directions or orientations as mirror images of each other. The first plurality of cutting elements 34 and the second plurality 44 comprise cutting directions or orientations may be opposite each other.

[0041] The first position of the first plurality of cutting elements 34 is different than the second position of the second plurality of cutting elements 44. Alternatively, the first position is the same as the first position. The second position is 180 degrees apart from the first position. The second position and the first position comprise diametrically opposing positions. In one embodiment, the first plurality of cutting elements 34 is positioned over a portion of the plurality of holes 39 at a first position on the outer surface 32 and the second plurality of cutting elements 44 is positioned over a portion of the plurality of holes 39 at a second position on the innersurface 42, the first position is diametrically opposed to the second position. The different positions and orientations of the first plurality of cutting elements 34 and the second plurality of cutting elements 44 allow the dome osteotomy reamer 6, 96, 126, 128, 130 to have dual-sided reaming or cutting capabilities without removing the dome osteotomy reamer 6, 96, 126, 128, 130 from the surgical site and risk mating alignment and any complications from malunions or non-unions.

[0042] The first plurality of cutting elements 34 and the second plurality of cutting elements 44 comprises a cutting element shape and a cutting surface 46, 48. The cutting element shape comprises a convex, arcuate shape or a dome shape. Alternatively, the cutting element shape comprises a substantially convex, arcuate shape or a dome shape. At least a portion of the cutting surfaces 46, 48 may comprise a sharpened edge.

[0043] The dome osteotomy reamer 6, 96, 126, 128, 130 comprises at least one connection opening 36. The connection or adapter opening 36 is sized and configured to receive a portion of the reamer adapter 4 and / or a portion of a reamer shaft 10a, 10b. The adapter or connection opening 36 comprises an adapter or connection opening axis, the adapter or connection opening axis is concentric with a central axis of the dome osteotomy reamer 6, 96, 126, 128, 130. The adapter or connection opening 36 further comprises an opening shape, an inner surface 50, and an opening depth or wall thickness 52. The opening depth or wall thickness 52 is greater than the wall thickness 54 of the hollow body 31. The inner surface 50 will engage, contact and / or mate with a portion of the outer surface of the coupling band 20 of the reamer adapter 6 or a portion of the reamer shaft 10a, 10b. The opening shape of the adapter or connection opening 36 may comprise a circle or a polygon shape. The opening shape may further comprise a star shape, an “H” shape or an “X” shape.

[0044] The dome osteotomy reamer 6, 96, 126, 128, 130 may comprise a platform 37. The platform 37 is disposed onto a portion of the outer surface 32 of the hollow body 31. The platform 37 surrounds a portion of the perimeter of the adapter or connection opening 36 and is disposed onto a portion of the outer surface 32 of the hollow body. The platform 37 extends above the outer surface 32 of the hollow body to have a platform height 114. The platform 37 comprises a platform top surface 38. The top surface 38 may be flat or planar.

[0045] The dome osteotomy reamer 6, 96, 126, 128, 130 may comprise at least one connection slot 98. The at least one connection slot 98 is in communication with the at least one adapter or connection opening 36. The at least one connection slot 98 comprises a slot inner surface 108, a first end 118 and a second end 120. The slot inner surface 38 comprises a first portion 110, a second portion 112 and a third portion 116. The first portion 110 is adjacentor near the first end 118. The second portion 112 is disposed between the first portion 110 and the third portion 116. The first portion 110 is adjacent or near the adapter or connection opening 36. The at least one connection slot 98 is sized and configured to receive a portion of the reamer shaft 10a, 10b. The at least one connection slot 98 is sized and configured to receive a first side and a second side of the reamer shaft 10a, 10b. The first side and the second side may comprise a flat, planar surface.

[0046] The at least one connection slot 98 comprises a first width 102 and a second width 104. The first width 102 is larger than the second width 104. The at least one connection slot 98 is tapered along a longitudinal axis of the at least one connection slot 98. The tapering extends from a first end 118 towards the second end 120. In one embodiment, the at least one connection slot 98 comprises a first width 102 that is greater than the second width 104 to create a taper. The first width 102 is adjacent to the first end 118 and the second width is adjacent to the second end 120.

[0047] The first portion 110 of the slot inner surface 108 may comprise a flat and / or planar surface. The second portion 112 of the slot inner surface 108 may comprise a bevel or a chamfer. The bevel or chamfer is cut at an angle, the angle slopes downward from the outer surface 32 towards the inner surface 42. The bevel or chamfer is angled transverse or substantially transverse to the longitudinal axis of the at least one connection slot 98. Such an angle allows the second portion width 103 to be smaller than the first width 102 and the second width 104. Such a bevel or chamfer in the second portion 112 of the slot inner surface 108 helps align and center the adapter 4 or the reamer shaft 10a, 10b for further engagement and locking (i.e., produces a tightening, tactile effect while engaging). The third portion 110 of the slot inner surface 108 is beveled or chamfered or flat / planar.

[0048] The dome osteotomy reamer 6, 96, 126, 128, 130 may comprise at least one tool opening 106. The at least one tool opening 106 extends from an outer surface 32 through the inner surface 42 of the hollow body 31. The at least one tool opening 106 is sized and configured to receive a portion of a surgical tool. The surgical tool may be used to assist the surgeon to remove the dome osteotomy reamer 6, 96, 126, 128, 130 from the reamer adapter 4 and / or the reamer shaft 10a, 10b. The dome osteotomy reamer 6, 96, 126, 128, 130 is positioned between the adapter or connection opening 36 and the outer rim 40. The at least one tool opening 106 is spaced apart from the adapter or connection opening 36.

[0049] In one embodiment, the opening shape of the connector opening 36 may comprise a hexagon. The opening shape of the adapter or connection opening 36 may comprise the same shape as the coupling band cross-sectional shape. Accordingly, theopening shape of the adapter opening 36 may match or substantially match the coupling band cross-sectional shape. In another embodiment, the adapter or connection opening 36 may comprise an “X” shape.

[0050] The hollow body shape of the hollow body 31 may comprise a convex, hemispherical or dome shape 55 and / or a substantially convex, hemispherical or dome shape 56, 57 as shown in FIG. 5A. The hollow body shape may further comprise a truncated hemispherical or dome shape as shown in FIG. 5B and 5C. The truncation may comprise flat or planar sections or surfaces of the hollow body 31. The truncation allows one or more locations to be removed or replaced with the flat or planar sections or surfaces. The truncation may be disposed on a top surface 57 and / or on one or more the sides 56. In one exemplary embodiment, the truncated portion of the hollow body 31 does not comprise a plurality of holes 39, a first plurality of cutting elements 34 and a second plurality of cutting elements 44 to help minimize damage to soft tissue. In another embodiment, the truncated portion of the hollow body 31 does comprise a plurality of holes 39, a first plurality of cutting elements 34 and a second plurality of cutting elements 44.

[0051] The dome osteotomy reamer 6, 96, 126, 128, 130 may comprise different diameters or widths 43 to match or substantially match the width of a patient’s bone. The diameters may comprise a range of equal to or greater than 20 mm; a range of equal to or greater than 30 mm; and / or a range of equal to or greater than 35 mm. The diameter may further include a range of 20 mm to 60 mm and / or 35 mm to 55 mm. The diameters may be available in 2 mm, 3 mm or 5 mm increments.

[0052] The dome osteotomy reamer 6, 96, 126, 128, 130 may comprise different heights 33. The different heights may comprise a range of 5 mm to 50 mm; the heights may comprise a range of 10 mm to 50 mm; the heights may comprise at least 10 mm or greater; the heights may comprise at least 20 mm or greater; the heights may comprise at least 60 mm or less; and / or the heights may comprise at least 50 mm or less. The height 33 may be available as small, medium, large, extra-large and / or any other combination

[0053] The dome osteotomy reamer 6, 96, 126, 128, 130 may comprise different radius of curvatures (not shown). The radius of curvature may comprise a range of 10 mm to 60 mm; the radius of curvature may comprise a range of 15 mm to 50 mm; the radius of curvature may comprise a range of 20 mm to 45 mm; the radius of curvature may comprise at least 10 mm or greater; the radius of curvature may comprise at least 20 mm or greater; the radius of curvature may comprise at least 25 mm or greater and / or the radius of curvature may comprise at least 30 mm or greater.

[0054] The dome osteotomy reamer 6, 96, 126, 128, 130 may comprise a material. The material may include a polymer, ceramic, a metal, a metal alloy and / or any combination thereof. The metal and metal alloys may comprise cobalt-chrome, titanium alloys, aluminum, and / or stainless steel.

[0055] Method of Using the Dome Osteotomy Reamer or Reamer Assembly

[0056] The following method 76 is a unique and novel method of using the dome osteotomy reamer 6, 96, 126, 128, 130 or the reamer assembly 2,8 for a variety of orthopedic surgical procedures, including, but not limited to multi-planar deformity correction, malunion, non-union, and / or fracture fixation. The method 76 executes the contouring of surfaces of a plurality of bone portions to create a convex-concave junction or ball-and-socket joint that is advantageous for multiaxial or multiplanar corrections. Such a method is executed without the use of various additional, unnecessary instruments, as well as the steps are performed more efficiently and reduces or eliminates bone surface mismatch, mating or docking if the cuts are not properly performed. Furthermore, the method 76 can be used in open and / or minimally invasive surgeries. Also, the method 76 may further be used in conjunction with image guided navigational systems, or other systems for precision guiding of the dome osteotomy reamer 6.

[0057] FIGS. 6A-6E, 7A-7B and 9A-9E depict at least one embodiment of a method 76 of using the dome osteotomy reamer 6, 96, 126, 128, 130 or reamer assembly 2, 8, 132. In one embodiment, the method 76 of using the dome osteotomy reamer 6, 96, 126, 128, 130 or reamer assembly 2, 8, 132 comprises the steps of: completing the desired osteotomy to create a first and second portions of a bone 78; creating a first passageway into a first portion of the bone 80; aligning first and second portions of the bone 82; creating a second passageway into a second portion of the bone 84; engaging the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 between the first and second portions of the bone 86; activating the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 88 to create a polyaxial joint.

[0058] In another embodiment, the method 76 further includes restoring anatomic alignment 90. In another embodiment, the method 76 further includes restoring anatomic alignment 90 and fixating the first and second bone portions 92. In another embodiment, the method 76 further includes restoring anatomic alignment 90, removing the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2,8, 132 (not shown), and fixating the first and second bone portions 92. In another embodiment, the method 76 further includes a preoperative assessment (not shown).

[0059] In another alternate embodiment, the method of using the dome osteotomy reamer 6, 96, 126, 128, 130 or reamer assembly 2, 8, 132 comprises the steps of: completing the desired osteotomy to create a first and second portions of a bone 78; creating a first passageway into a first portion of the bone 80; aligning first and second portions of the bone 82; creating a second passageway into a second portion of the bone 84; contouring the first and second portions of the bone by activating the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 to create a polyaxial joint.

[0060] In another embodiment, the alternate method further includes restoring anatomic alignment 90. In another embodiment, the alternate method further includes restoring anatomic alignment 90 and fixating the first and second bone portions 92. In another embodiment, the alternate method further includes removing the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2,8, 132 (not shown), restoring anatomic alignment 90, and fixating the first and second bone portions 92. In another embodiment, the alternate method further includes a preoperative assessment (not shown).

[0061] In another alternate embodiment, the method of using the dome osteotomy reamer 6, 96, 126, 128, 130 or reamer assembly 2, 8, 132 comprises the steps of: completing the desired osteotomy to create a first and second portions of a bone 78; creating a first passageway into a first portion of the bone 80; aligning first and second portions of the bone 82; creating a second passageway into a second portion of the bone 84; removing the reamer bit from the reamer shaft from the first or second passageway; engaging the dome osteotomy reamer 6, 96, 126, 128, 130 to the reamer shaft; contouring the first and second portions of the bone by activating the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 to create a polyaxial joint.

[0062] In another embodiment, the alternate method further includes restoring anatomic alignment 90. In another embodiment, the alternate method further includes restoring anatomic alignment 90 and fixating the first and second bone portions 92. In another embodiment, the alternate method further includes removing the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 (not shown), restoring anatomic alignment 90, and fixating the first and second bone portions 92. In another embodiment, the alternate method further includes a preoperative assessment (not shown).

[0063] The step of completing the desired osteotomy to create a first portion (near side) and second portions (far side) of a bone 78 comprises completing the desired surgical approach and osteotomy 76 of the surgeon. In one embodiment, the osteotomy approach 76 may include a transverse osteotomy. Alternatively, other osteotomy approaches may be used that areknown in the art. The desired osteotomy of the bone 60 may create a first bone portion 60a and a second bone portion 60b. Accordingly, different osteotomies may be performed to create three or more bone portions.

[0064] The step of creating the first passageway 62a into a first portion 60a of the bone 80 may require surgical tools. The step of creating the first passageway 62a into a first portion 60a of the bone comprises at least one or more of the steps of: extending a first guidewire into the bone and / or the bone intramedullary canal; securing a reamer bit to the reamer shaft and the reamer shaft to the rotary drill; aligning or following the first guidewire with the reamer shaft and reamer bit; and / or removing the reamer shaft with reamer bit from the first passageway 62a. A rotary drill and / or a reamer shaft with a reamer bit may be provided to the surgeon or robotic assistant. The rotary drill may be a manual, hand operated tool and / or a power tool. The rotary drill may be coupled to the rotary drill reamer and the reamer bit. At least a portion of the reamer shaft includes a reamer bit with cutting elements. A guidewire may be advanced into a first portion of the bone 62a and the reamer shaft is inserted over the guidewire to the desired depth is achieved (e.g., equal to greater than 10 mm). The surgeon may activate the rotary drill so that the cutting elements gradually cut and / or remove cartilage and bone in small pieces to create the first passageway. Alternatively, the creation of the passageway may be completed progressively, increasing the reamer bit on the reamer shaft until a first passageway has been created.

[0065] The step of aligning first and second portions of the bone 82 allows precise, centralized passage of the rotary drill and / or the reamer shaft. The first portion of the bone (near side) and the second portion of the bone (far side) may be mated or coupled to allow the advancement of a second guidewire 63. The second guidewire is maintained to be coaxial with a central axis of the first and second bone portions. The second guidewire may be advanced across the osteotomy site to ensure that centralized positioning is maintained. Surgeon may confirm with imaging and alignment may be retrograde if required.

[0066] The step of creating the second passageway 62b into a second portion 60b of the bone 84 may require surgical tools. The step of creating the first passageway 62b into a second portion 60b of the bone comprises at least one or more of the steps of: extending a second guidewire into the bone and / or the bone intramedullary canal; securing a reamer bit to the reamer shaft and reamer shaft to the rotary drill; aligning or following the second guidewire with the reamer shaft and reamer bit; and / or removing the reamer shaft with reamer bit from the first passageway 62a. A rotary drill and / or a rotary drill shaft may be provided to the surgeon or robotic assistant. The rotary drill may be a manual, hand operated tool and / or a power tool. Therotary drill may be coupled to the reamer shaft with the reamer bit. At least a portion of the reamer shaft includes a reamer bit with cutting elements. The rotary drill and / or reamer shaft with reamer bit are advanced over the second guidewire to the desired depth is achieved (e.g., equal to greater than 10 mm). The surgeon may activate the rotary drill so that the cutting elements of the reamer bit gradually cut and / or remove cartilage and bone in small pieces to create the second passageway. Alternatively, the creation of the passageway may be completed progressively, increasing the reamer bit size on the reamer shaft until a second passageway has been created. The first guidewire may comprise the same guidewire as the second guidewire. The first guidewire may comprise a different guidewire than the second guidewire.

[0067] The step of engaging the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 between the first and second portions of the bone 86 may comprise one or more steps of the following: removing the reamer shaft with reamer bit from the first passageway 62a and / or second passageway 62b; disconnecting the reamer bit from the reamer shaft; extending the reamer shaft that is connected to the rotary drill into the first passageway 62a and / or second passageway 62b; securing the dome osteotomy reamer 6, 96 and / or the dome osteotomy reamer assembly 2, 8, 132 to the free end of the reamer shaft.

[0068] The first and second bone portions are distracted. The second guidewire may be retracted to allow engagement with the dome osteotomy reamer 6, 96, 126, 128, 130.Alternatively, the second guidewire may engage with the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 to ensure that the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 is centralized or aligned with the central axis of the first and second bone portions 86 and to lock the reamer adapter 4 and / or the reamer shaft 10a, 10b to the dome osteotomy reamer 6, 96, 126, 128, 130.

[0069] In one embodiment, the reamer shaft 10a, 10b is re-inserted or extended into the second passageway 62b. The reamer shaft 10a, 10b should be removably connected to the drill and should follow the aligned trajectory of the second guidewire until at least a portion of the reamer shaft free end or tip extends above the resected plane of the second bone portion. The second guidewire may be retracted slightly above, below or at the top surface of the reamer shaft free end or tip. The dome osteotomy reamer 6, 96, 126, 128, 130 may engage with the free end or tip of the reamer shaft 10b.

[0070] Engagement of the dome osteotomy reamer 6, 96, 126, 128, 130 may comprise one or more of the steps of: positioning the dome osteotomy reamer 6, 96, 126, 128, 130 between the first bone portion and the second bone portion; inserting or extending at least a portion of the free end or tip of the reamer shaft 10b into a first end of the at least one connection slot 98 of the dome osteotomy reamer 6, 96, 126, 128, 130; sliding the dome osteotomy reamer 6, 96, 126, 128, 130 from the first end of the at least one connection slot 98 to the second end of the at least one connection slot 98; and / or locking or securing the dome osteotomy reamer 6, 96, 126, 128, 130 to the reamer shaft 10b. The locking or securing step may comprise the step of twisting or turning the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the reamer shaft 10b relative to each other. The twisting or turning may comprise a first position of 0 degrees, to a second position of a range of 15 degrees to 20 degrees.Alternatively, the twisting or turning may comprise a first position that includes an unlocked assembly 132, to a second position, a locked assembly 132.

[0071] In another embodiment, the engaging of the second guidewire with the reamer shaft 10a of the dome osteotomy reamer assembly 2, 8 allows the segmented sleeve portions to expand and prevent withdrawal of the reamer adapter 4 and / or the reamer shaft 10a during high pressure or forces. A first surface of the first bone portion should contact or engage with a portion of the outer surface or a portion of the inner surface of the dome osteotomy reamer 6, 96, 126, 128, 130. Accordingly, the second surface of the second bone portion should contact or engage with a portion of the outer surface or a portion of the inner surface of the dome osteotomy reamer 6. The reamer adapter 4 and / or the reamer shaft 10a are removably coupled together. The free end or tip of the reamer shaft 10a is similar to and / or substantially similar to the design of the reamer adapter 4.

[0072] The step of contouring the first and second portions of the bone to create a polyaxial joint 94 and / or the step of activating the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 88, 2, 8, 132 to create a polyaxial joint may comprise one or more of the steps of: engaging the dome osteotomy reamer 6, 96, 126, 128, 130 between the first and second bone portions; activating the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 to create a polyaxial joint. The surgeon or robotic assistant may provide or apply a first force 70 against a portion of the first surface or first resected surface of the first portion of the bone. The surgeon or robotic assistant may activate the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 to begin rotation in a clockwise 66 manner. While in rotation, the first plurality of cutting elements and / or the plurality of holes of the dome osteotomyreamer 6, 96,126, 128, 130 are cutting bone and cartilage into small pieces which pass through the plurality of holes to be partially contained within the interior of the hollow body 31 of the dome osteotomy reamer 6, 96, 126, 128, 130 or exiting away from the outer surface of the hollow body 31 of the dome osteotomy reamer 6, 96, 126, 128, 130. The first force can create a first contoured bone end and / or a concave or convex surface or substantially concave or convex surface in the first bone portion. The first force may include a compression or a tension force (e.g., pushing or pulling).

[0073] The surgeon may continue to provide or apply a second force 68 against a portion of the second surface or a second resected surface of the second portion of the bone. The surgeon or robotic assistant may activate the dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2, 8, 132 to begin rotation in a counterclockwise 67 manner. While in rotation, the second plurality of cutting elements and / or the plurality of holes of the dome osteotomy reamer 6, 96, 126, 128, 130 are cutting bone and cartilage into small pieces which pass through the plurality of holes to be partially contained within the interior of the hollow body 31 of the dome osteotomy reamer 6, 96, 126, 128, 130 or exiting away from the outer surface of the hollow body 31 of the dome osteotomy reamer 6, 96, 126, 128, 130. The second force can create a second contoured bone end and / or a concave or convex surface in the second bone portion. The first force may include compression or tension (e.g., pushing or pulling). In one embodiment, this step does not require removal of the dome osteotomy reamer or detachment from the reamer shaft. Contouring of the first portion and the second portion of the bone may occur while engaging in a push and a subsequent pull against the resected bone surfaces and / or it may occur simultaneously while pushing and pulling the bone portions at the same time.

[0074] The dome osteotomy reamer 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assembly 2,8, 132 (not shown) and / or any other tools may be removed. The first surface on the first portion of the bone can be mated with the second surface on the second portion of the bone to create a polyaxial joint. The concave surface 74 of a first or second bone portion may be mated with the matching convex surface 72 of a first or second bone portion to create a polyaxial joint. Prior to the contouring step, the surgeon may elect to compress the first and second bone portions by using any of the surgical fixation systems known in the art. Any of the dome osteotomy reamers 6, 96, 126, 128, 130 and / or the dome osteotomy reamer assemblies 2, 8, 132 can be used in conjunction with image guided navigational systems, or other systems for precision guiding of the reamers.

[0075] The polyaxial joint that is created after contouring, or the convex 72-and-concave 74 junction, is intended to create a larger surface area at the bone junction site to facilitate increased bridging bone and enhanced stability compared with a transverse resected junctions. The convex 72-and-concave 74 nature of the junctional fit also allows for greater degrees of freedom (multiaxial positioning) in reducing the allograft to bone and / or bone-to-bone.

[0076] The step of restoring anatomic alignment of the first 60a and the second 60b portions of the bone 90 may be performed using desired techniques known in the art. The step may be used in conjunction with any allografts. Once the soft tissue has allowed for correction and the alignment is achieved using either a universal distractor or other means, compression and fixation can be applied. The step of fixating the first 60a and second 60b bone portions can be performed using desired techniques known in the art. Either internal or external fixation may be considered. Once compression is applied and the fracture is stable, the osteotomy can again be assessed for any bone defects or gaps using imaging. Should there be any critical gaps that may impair fracture healing, the gaps may be grafted with autologous bone graft.

[0077] Example Embodiments

[0078] In one embodiment, the bone reamer comprising: a hollow body, the hollow body comprises a central axis, a body shape, an outer surface, an inner surface, a plurality of openings, and an adapter opening or orifice; and a first plurality of cutting members or elements, the first plurality of cutting members comprises a first plurality of cutting member shapes, the first plurality of cutting members disposed onto the outer surface of the hollow body adjacent to the plurality of openings in a first direction; and a second plurality of cutting members or elements, the second plurality of cutting members comprises a second plurality of cutting member shapes, the second plurality of cutting members disposed onto the inner surface of the hollow body adjacent to the plurality of openings in a second direction.

[0079] The body shape comprises a generally or substantially hemispherical shape. The body shape comprises a generally or substantially truncated hemispherical shape. The truncation is disposed onto a top surface of the hollow body. The truncation is disposed onto a side surface of the hollow body. The truncation is disposed on at least two opposing sides of hollow body. The top surface of the hollow body comprises a flat, planar surface. At least one side of the hollow body comprises a flat, planar surface.

[0080] The first plurality of cutting members is oriented in a first direction and the second plurality of cutting members are oriented in a second direction, the first direction and the second direction are different. The first plurality of cutting members comprises a mirror image of the second plurality of cutting members. The first plurality of cutting members and the secondplurality of cutting members are diametrically opposed. The first plurality of cutting members and the second plurality of cutting members are substantially dome shaped.

[0081] The bone reamer further comprises a reamer adapter. The bone reamer further comprises a reamer shaft. The bone reamer further comprises an adapter opening. The adapter opening extends through the top surface. The adapter opening of the bone reamer is sized and configured to receive a portion of the reamer adapter. The bone reamer comprises a reamer wall thickness and the adapter opening comprises an opening wall thickness, the opening thickness is greater than the reamer wall thickness. The bone reamer comprises a metal. The hollow body of the bone reamer comprises a diameter of at least 30 mm.

[0082] In one embodiment, the bone reamer system comprises a bone reamer. The bone reamer system may further comprise a bone reamer adapter. The bone reamer system may further comprise a bone reamer shaft. The bone reamer system may comprise a bone reamer, bone reamer shaft and a bone reamer adapter. The bone reamer may engage with the bone reamer adapter, the bone reamer adapter engages to the bone reamer shaft. The bone reamer may engage directly to the bone reamer shaft. The bone reamer shaft may be coupled to a rotary drill.

[0083] In another embodiment, the method of using the dome osteotomy reamer comprises the steps of completing the desired osteotomy to create a first and second portions of a bone; creating a first passageway into a first portion of the bone; aligning the first and second portions of the bone; creating a second passageway into the second portion of the bone; and contouring a portion of the of the first portion of the bone and the second portion of the bone using the dome osteotomy reamer to create a polyaxial joint.

[0084] The method further includes the steps of: restoring anatomic alignment; and fixating the first and second bone portions of the bone. The step of contouring further comprises the steps of: engaging or positioning the dome osteotomy reamer and / or the dome osteotomy reamer assembly between the first and second portions of the bone; and activating the dome osteotomy reamer. The step of contouring further comprises the step of activating the dome osteotomy reamer. The step of activating the dome osteotomy reamer comprises the steps of: applying a first force against a first surface of the first portion of the bone and rotating the dome osteotomy reamer in a first cutting direction; and applying a second force against a second surface of the second portion of the bone and rotating the dome osteotomy reamer in a second cutting direction.

[0085] Alternatively, the step of contouring further comprises the steps of: engaging the dome osteotomy bone reamer between the first and second portions of the bone; and activatingthe dome osteotomy reamer. The step of contouring and / or the step of activating comprises the steps of: applying a first force against a first surface of the first portion of the bone and rotating the dome osteotomy reamer in a first cutting direction; and applying a second force against a second surface of the second portion of the bone and rotating the dome osteotomy reamer in a second cutting direction. The step of contouring and / or the step of activating may further comprise inserting a reamer shaft through a first and / or second passageway; engaging or positioning the dome osteotomy reamer and / or the dome osteotomy reamer assembly between the first and second portions of the bone; and engaging or coupling the dome osteotomy reamer to the reamer shaft.

[0086] The first force and the second force are different. The first force comprises compression and the second force comprises tension. The first cutting direction and the second cutting direction are different. The first cutting direction comprises a clockwise direction and the second cutting direction comprises a counterclockwise direction.

[0087] The polyaxial joint comprises a convex surface and a concave surface. The concave surface comprises the first surface of the first portion of the bone or the second surface of the second portion. The convex surface comprises the first surface of the first portion of the bone or the second surface of the second portion of the bone.

Claims

CLAIMSl / we claim:

1. A bone reamer comprising:a hollow body, the hollow body comprises a central axis, an outer surface, an inner surface, a plurality of openings, and a connection opening, each of the plurality of openings spaced apart and extend from the outer surface through the inner surface; and a first plurality of cutting elements, the first plurality of cutting elements disposed onto the outer surface of the hollow body adjacent to the plurality of openings at a first position and oriented in a first direction; anda second plurality of cutting elements, the second plurality of cutting members disposed onto the inner surface of the hollow body adjacent to the plurality of openings at a second position and oriented in a second direction.

2. The bone reamer of claim 1 , wherein the hollow body comprises a generally or substantially hemispherical shape.

3. The bone reamer of claim 1 , wherein the hollow body comprises a generally or substantially truncated hemispherical shape.

4. The bone reamer of claim 3, wherein the truncation is disposed onto a top surface of the hollow body.

5. The bone reamer of claim 1 , wherein the first direction and the second direction are different.

6. The bone reamer of claim 1 , wherein the first direction of the first plurality of cutting elements and the second direction of the second plurality of cutting elements comprises a mirror image.

7. The bone reamer of claim 1 , wherein first position of the first plurality of cutting members and the second position of the second plurality of cutting members are diametrically opposed.

8. The bone reamer of claim 1 , wherein the first plurality of cutting members and the second plurality of cutting members are substantially dome shaped.

9. The bone reamer of claim 1 , wherein the hollow body further comprises at least one connection slot, the at least one connection slot is in communication with the connection opening.

10. The bone reamer of claim 9, wherein the at least one connection slot and the connection opening is sized and configured to receive a portion of a reamer shaft.

11. The method of using the dome osteotomy bone reamer system comprises the steps of: completing the desired osteotomy to create a first and second portions of a bone; creating a first passageway into a first portion of the bone;aligning the first and second portions of the bone;creating a second passageway into the second portion of the bone; securing the dome osteotomy bone reamer to a portion of the reamer shaft positioned between a first portion of the bone and the second portion of the bone; applying a first force against a portion of a first resected surface of the first portion of the bone and activating the dome osteotomy reamer in a first cutting direction to create a first contoured bone end of the first portion of the bone; andapplying a second force against a portion of a second resected surface of the second portion of the bone and rotating the dome osteotomy reamer in a second cutting direction to create a second contoured bone end of the second portion of the bone.

12. The method of claim 11, wherein the method further comprises the step of engaging the first contoured bone end of the first portion of the bone to the second contoured bone end of the second portion of the bone to create a polyaxial joint.

13. The method of claim 11 , wherein the method further comprises the steps of:restoring anatomic alignment; andfixating the first and second bone portions of the bone.

14. The method of claim 11, wherein the first force and the second force are different.

15. The method of claim 11, wherein the first force comprises compression and the second force comprises tension.

16. The method of claim 11, wherein the first force comprises tension and the second force comprises compression.

17. The method of 11, wherein the first cutting direction and the second cutting direction are different.

18. The method of claim 17, wherein the first cutting direction comprises a clockwise direction and the second cutting direction comprises a counterclockwise direction.

19. The method of claim 12, wherein the polyaxial joint comprises a convex surface and a concave surface.

20. The method of claim 11 , wherein the step of securing the dome osteotomy reamer to a portion of the reamer shaft comprises the steps of:engaging at least a portion a free end of the reamer shaft into the at least one connection slot of the dome osteotomy reamer;sliding the dome osteotomy reamer relative to the reamer shaft from a first position to a second position; andlocking the dome osteotomy reamer to the portion of the free end of the reamer shaft.

21. The method of claim 20, wherein the locking of the dome osteotomy reamer comprises twisting the dome osteotomy reamer or the reamer shaft.

22. The method of claim 21, wherein the twisting comprises a clockwise twist or a counterclockwise twist of at least 10 degrees or greater.

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