US20220287747A1 - Bone plating kit for foot and ankle applications - Google Patents

Abstract

A bone plate kit may be provided for a foot or ankle orthopedic procedure, such as a lapidus procedure. In some examples, the bone plate kit includes a sterile container that holds multiple unicortical bone plate fasteners and one or more bone plates. For example, the kit may contain two bone plates configured to be used together during a tarsal-metatarsal fusion procedure. Each of the two bone plates may be configured to span different regions of a tarsal-metatarsal joint. The unicortical bone plate fasteners can be used to secure the two bone plates to the first metatarsal and medial cuneiform of a patient undergoing a procedure. In some configurations, one of the bone plates is a helical bone plate while the other bone plate may or may not be a helical bone plate.

Description

RELATED APPLICATION
• This application is a continuation of U.S. patent application Ser. No. 16/278,264, filed Feb. 18, 2019, which is a continuation of U.S. patent application Ser. No. 15/047,343, filed Feb. 18, 2016, now U.S. Pat. No. 10,245,086, issued Apr. 2, 2019, which in turn claims the benefit of U.S. Provisional Patent Application No. 62/117,788, filed Feb. 18, 2015. The entire contents of each of these applications are incorporated herein by reference.
TECHNICAL FIELD
• This disclosure relates to a disposable single-use surgical kit for an orthopedic procedure on a foot or ankle and methods related to the disposable single-use surgical kit.
BACKGROUND
• Bones, such as the bones of a foot, may be anatomically misaligned. In certain circumstances, surgical intervention is required to correctly align the bones to reduce patient discomfort and improve patient quality of life. Surgical intervention may involve cutting one or more of the misaligned bones and then physically realigning the bones into an anatomically corrected position. A bone plate or multiple bone plates may be used to hold the bones in the anatomically corrected position, helping to prevent the bones from shifting back to their misaligned position.
SUMMARY
• In general, this disclosure is directed to a bone plating kit for use in an orthopedic procedure performed on the foot and/or ankle of a patient. In some examples, the bone plating kit includes one or more bone plates and a corresponding number of bone plate fasteners that are specifically selected and configured for a particular orthopedic procedure. For example, the bone plating kit may contain two bone plates configured to be used together during a tarsal-metatarsal fusion procedure. Each bone plate may be configured (e.g., sized and/or shaped) to span different regions of the tarsal-metatarsal joint. For example, one bone plate may be configured to span from a dorsal region of a medial cuneiform to a medial region of a first metatarsal and a second bone plate may be being configured to span from a plantar region of a first metatarsal to a medial region of a medial cuneiform. To attach the two bone plates to different bones being fused, the kit may include a number of unicortical fasteners at least equal to the number of fastener openings on the bone plates within the kit. The kit may be used on a wide variety of different patients having variations in anatomy size and shape. The kit may be used in lieu of stocking a large number of different sized bone plates and fasteners.
• In one example, a disposable single-use surgical kit for a foot or ankle orthopedic procedure is described that includes a sterile container, a plurality of unicortical fasteners, and at least one but no more than four bone plates, each contained within the sterile container. Each bone plate may have body having a top surface and a bone facing surface opposite the top surface as well as at least one fixation hole extending through the body from the top surface to the bone facing surface. The at least one fixation hole can be configured for receiving one of the plurality of unicortical bone plate fasteners included in the sterile container.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a top plan view of an embodiment of disposable single-use surgical kit including a sterile container with various surgical items in the sterile container.
• FIG. 2A is a perspective view showing embodiments of bone plates, bone plate fasteners, and an external fastener with a washer.
• FIG. 2B is a top plan view of a top surface of the bone plate ofFIG. 2A.
• FIGS. 2C and 2D show a top plan view and perspective view, respectively, of a bone facing surface of the bone plate ofFIG. 2A.
• FIG. 2E shows an elevational view of the bone plate ofFIG. 2A.
• FIG. 2F shows a close-up elevational end view of the bone plate ofFIG. 2A.
• FIGS. 2G and 2H show an elevational view and perspective view, respectively, of the embodiment of the bone plate ofFIG. 2A including attachment members.
• FIGS. 2I and 2J illustrate different perspective views of an example bone plate having a helical curvature.
• FIG. 3 is a perspective view of one embodiment of plate manipulation instruments.
• FIG. 4 is a perspective view of an embodiment of a driver member that can also serve as a plate manipulation instrument.
• FIG. 5 is a perspective view of another embodiment of a driver member that can also serve as a plate manipulation instrument.
• FIG. 6 is a perspective view of one embodiment of bone cut pins.
• FIG. 7 is a perspective view of one embodiment of bone fixation pins.
• FIG. 8 is a perspective view of an embodiment of a single external fastener bone cut pin.
• FIG. 9A is a perspective view of a first embodiment of a bone preparation instrument with some components shown in an exploded view.
• FIG. 9B is a perspective view of the bone preparation instrument ofFIG. 9A assembled.
• FIG. 10A a perspective view of a second embodiment of a bone preparation instrument.
• FIG. 10B is a side elevational view of the bone preparation instrument ofFIG. 10A.
• FIG. 10C is a perspective view of the bone preparation instrument ofFIG. 10A showing guide members of the bone preparation instrument aligned at a skewed angle relative to a block of the bone preparation instrument.
• FIGS. 11A and 11B show perspective and cross-sectional views, respectively, of a third embodiment of a bone preparation instrument.
• FIG. 12 is a perspective view of one embodiment of bone preparation fixation pins.
DETAILED DESCRIPTION
• The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides some practical illustrations for implementing exemplary embodiments of the present invention. Examples of constructions, materials, and dimensions are provided for selected elements, and all other elements employ that which is known to those of ordinary skill in the field of the invention. Those skilled in the art will recognize that many of the noted examples have a variety of suitable alternatives.
• Embodiments of the present invention include a disposable single-use surgical kit. The terms “disposable” and “single-use” are meant to convey that the surgical kit, in addition to all components included in the surgical kit, is intended for use on only one surgical patient. After the surgical procedure on the one surgical patient is completed, any components that are not implanted into the one surgical patient can be discarded using conventional methods.
• Examples of the disposable single-use surgical kit can be configured such that the contents of the disposable single-use surgical kit are suited for a particular surgical procedure on the one surgical patient. For instance, an exemplary disposable single-use surgical kit can include only components suited for a Lapidus/tarsal-metatarsal (TMT) fusion procedure on one surgical patient. Similarly, other exemplary disposable single-use surgical kits can include components only suited for a Metatarsal Base Wedge procedure, metatarsal-phalangeal (MTP) fusion procedure, Evans Lengthening procedure, or other procedure that addresses bone anatomy of the foot or hand of the one surgical patient.
• Using a disposable single-use surgical kit configured for a specific surgical procedure on a single surgical patient may diminish the need for a surgical facility to maintain a large inventory of individual components that otherwise must be combined at the surgical facility and sterilized prior to the surgical procedure. By combining components specifically suited for the particular surgical procedure for which the kit is intended, a commonality of components can be realized which may reduce the size and complexity of the kit. Additionally, the disposable single-use surgical kit can reduce the need for assistance from agents of the component manufacturers while ensuring that the appropriate components needed for the particular procedure are available and in sterile condition. Furthermore, the disposable single-use surgical kit can be designated with a unique code in order to facilitate expensing the cost of the kit to the one surgical patient.
• FIG. 1 is a top plan view of an embodiment of a disposable single-usesurgical kit10. Thekit10 includes asterile container20 in which various surgical items can be contained. Thecontainer20 can be sterilized using any appropriate sterilizing means (e.g., exposure to ethylene oxide, steam autoclave, gamma radiation). In one embodiment, the various surgical items can be placed into thecontainer20, and thecontainer20 and the various surgical items included in thecontainer20 can be sterilized in a single step. Thesterile container20 may be partially or wholly enclosed in a packaging that can serve to protect thecontainer20 as well as seal and maintain a sterility of thecontainer20. The packaging and/or thesterile container20 can be made of a transparent material, such as an appropriate polymer, to allow viewing of the surgical items included in thecontainer20.
• As noted, the disposable single-usesurgical kit10 can include various surgical items which may be retained in thesterile container20. Embodiments of thekit10 can include different surgical items and/or different quantities of similar surgical items depending on the specific surgical procedure for which the particular embodiment of thekit10 is to be used on the single surgical patient.
• For example, the embodiment of thekit10 illustrated inFIG. 1 has apartition30 for retaining one ormore bone plates40. Thepartition30 may, for instance, be integrally formed in thecontainer20 and used to compartmentalize the one ormore bone plates40 from the remainder of thecontainer20. Thepartition30 can be configured (e.g. sized, shaped) to retain the one ormore bone plates40 within thecontainer20 until the one ormore bone plates40 are removed from thecontainer20 at an appropriate time, such as during a surgical procedure and immediately prior to installation. In some embodiments, thecontainer20 can include at least onebone plate40 but no more than four bone plates40 (e.g. only one, two, three, or four bone plates). Including at least one and no more than fourbone plates40 in thecontainer20 of thekit10 allows thekit10 to be a disposable single-use surgical kit used for a specific surgical procedure on a single surgical patient. The at least one and no more than fourbone plates40 included in thecontainer20 can have similar or different configurations. Details on example configurations of the at least one and no more than fourbone plates40 will be discussed with reference to later figures.
• Thekit10 can also have apartition50 for retaining a plurality ofbone plate fasteners60 in thecontainer20. In some embodiments, thepartition50 can include aslot65 configured to hold thebone plate fasteners60 in a manner that allows thebone plate fasteners60 to slide along a longitudinal axis of theslot65. In some embodiments, a number ofbone plate fasteners60 included in thecontainer20 is equal to a total number of fixation holes (shown, e.g., inFIG. 2B) of thebone plates40 included in thecontainer20. In other embodiments, the number ofbone plate fasteners60 included in thecontainer20 is equal to a total number of fixation holes of thebone plates40 included in thecontainer20 plus one additionalbone plate fastener60. For example, where twobone plates40 are included in thecontainer20 and each of the twobone plates40 has four fixation holes (for a total of eight fixation holes), the number ofbone plate fasteners60 included in thecontainer20 can be nine. In yet other embodiments, the number ofbone plate fasteners60 included in thecontainer20 is equal to a total number of fixation holes of thebone plates40 included in thecontainer20 plus two additionalbone plate fasteners60. In certain embodiments, the number ofbone plate fasteners60 included in thecontainer20 is equal to a total number of fixation holes of thebone plates40 included in thecontainer20 plus three additionalbone plate fasteners60. In a specific embodiment, the number ofbone plate fasteners60 included in thecontainer20 is equal to a total number of fixation holes of thebone plates40 included in thecontainer20 plus four additionalbone plate fasteners60.
• Including one, two, three, or fourbone plate fasteners60 more than the number of fixation holes of thebone plates40 included in thecontainer20 can be beneficial in instances wherebone plate fasteners60 may be dropped or lost during a surgical procedure. Overall, including a number ofbone plate fasteners60 in thecontainer20 equal to a total number of fixation holes of thebone plates40 included in thecontainer20 and optionally plus one, two, three, or four additionalbone plate fasteners60 allows thekit10 to be a disposable single-use surgical kit used for a specific surgical procedure on a single surgical patient. In certain embodiments, nobone plate fasteners60 more than a total number of fixation holes of thebone plates40 included in thecontainer20 or more than a total number of fixation holes of thebone plates40 included in thecontainer20 plus one, two, three, or four are included in thekit10.
• In addition to thebone plates40 and thebone plate fasteners60, thekit10 may additionally havepartitions70 for retainingplate manipulation instruments80. In some embodiments, thecontainer20 can include at least one and no more than threeplate manipulation instruments80. Thekit10 can also havepartitions90 for retainingdriver members100. In some embodiments, thecontainer20 can include at least one and no more than threedriver members100. Furthermore, thekit10 may havepartitions110 for retaining bone cut pins120. In certain embodiments, thecontainer20 can include at least one and no more than four bone cut pins120. Additionally, thekit10 can havepartitions130 for retaining bone preparation fixation pins140. Thecontainer20 may have at least one and no more than ten bone preparation fixation pins140. Although not shown inFIG. 1, thecontainer20 may also have a partition adapted to receive a bone preparation instrument and thekit10 can include at least one bone preparation instrument. Including the specified number of surgical items in thecontainer20 allows thekit10 to be a disposable single-use surgical kit used for a specific surgical procedure on a single surgical patient.
• Thekit10 shown inFIG. 1 is only exemplary. Other embodiments of a disposable single-use surgical kit may not include one or more of the surgical items shown inFIG. 1 and/or may include surgical items in addition to those shown inFIG. 1. However, in some embodiments, if a particular surgical item is included in an embodiment of a disposable single-use surgical kit, the quantity of that surgical item in the kit is within the quantity ranges noted herein.
• FIGS. 2A-2H show thebone plates40.FIG. 2A shows a perspective view of thebone plates40, as well as thebone plate fasteners60 and anexternal fastener150. Each of thebone plate fasteners60 can have a head160 attached to a shaft170. The head160 of eachbone plate fastener60 may be the same size (e.g. same diameter). At least a portion of the shaft170 of eachbone plate fastener60 can include a threading, and such threading may mate with threading in fixation holes of bone plates. The shaft170 of each of thebone plate fasteners60 can have a length that is one of a first length, a second length, a third length, or a fourth length. The shaft170 of each one of the bone plate fasteners can have a diameter that is one of a first diameter, a second diameter, a third diameter, or a fourth diameter. Consequently, in some embodiments, thebone plate fasteners60 included in thekit10 ofFIG. 1 have shafts170 with no lengths other than the first, second, third and/or fourth lengths and/or no diameters other than the first, second, third and/or fourth diameters. In other words, in some embodiments thekit10 can includebone plate fasteners60 with at most four different lengths and/or at most four different diameters. Thebone plate fasteners60 included in thekit10 can have lengths that are the same or any combination of the first, second, third, and/or fourth lengths. Thebone plate fasteners60 included in thekit10 can also have diameters that are the same or any combination of the first, second, third, and/or fourth diameters. And thebone plate fasteners60 included in thekit10 can have lengths and diameters that are the same or any combination of the first, second, third, and/or fourth lengths and the first, second, third, and/or fourth diameters. Thebone plate fasteners60 can be used to secure thebone plates40 to one or more bones.
• In some applications, one or more (e.g., all) of thebone plate fasteners60 in the kit are unicortical bone plate fasteners. Cortical bone is one of the two types of osseous tissue that form bones. As its name implies, cortical bone forms the cortex, or outer shell, of a bone. Accordingly, a unicortical bone plate fastener may be configured (e.g., sized) to be inserted through one cortical surface of the bone but not an opposed cortical surface. For example, the tip of the unicortical bone plate fastener may reside within the cancellous or spongy bone of a bone structure (e.g., with the shaft extending through the first cortex and into the medullary structure of the bone structure) rather than passing through two cortical walls of the bone. The unicortical fastener may pass through a bone plate (e.g., with a head of the fastener bearing against the plate) and a tip of the fastener within the intramedullary cannel surrounded by cancellous bone, once installed and securing the bone plate to a desired bone. The use of unicortical bone plate fasteners instead of bicortical bone plate fasteners may help reduce the number of different sized and/or shaped fasteners required to be included inkit10.
• Other accessory screws not to intended or configured to be inserted through the fixation holes of the bone plates (e.g., bone plate40) may be included inkit10. For example,FIG. 2A illustratesexternal fastener150 that may be included in the kit. Embodiments of thekit10 can include in thecontainer20 at least one and no more than twoexternal fasteners150. The at least one and no more than twoexternal fasteners150 can have ahead180 attached to ashaft190. At least a portion of theshaft190 can include a threading. Awasher200 may be disposed around theshaft190, and as such thewasher200 can be sized appropriately to receive theexternal fastener150 via theshaft190. Additionally, the at least one and no more than twoexternal fasteners150 may be sized different than thebone plate fasteners60 included in thecontainer20, such that, for example, theexternal fasteners150 have a diameter different (e.g., greater) than a diameter of thebone plate fasteners60 and/or a length different (e.g., greater) than a length of the bone plate fasteners. The at least one and no more than twoexternal fasteners150 can be used, with or withoutwashers200, as a separate bone fixation means independent of thebone plates40. For example, theexternal fastener150 can have an end (e.g., an end of theexternal fastener150 opposite an end near which thewasher200 is disposed) inserted into a bone such to provide additional fixation of that bone.
• FIGS. 2B-2F illustrate an embodiment of abone plate40 that defines abody210.FIG. 2B illustrates a top plan view of atop surface220 of thebody210, whileFIGS. 2C and 2D illustrate a top plan view and perspective view, respectively, of abone facing surface230 of thebody210. For convenience, “bone facing surface” will refer to all surfaces generally facing bone when the plate is positioned on a bone, regardless of whether those surfaces are in the same plane.FIG. 2E is a side elevational view of thebone plate40, andFIG. 2F is a close-up end elevational view of a portion of thebone plate40.
• Thebody210, as noted, can include thetop surface220 and thebone facing surface230, which is on a side of thebody210 opposite thetop surface220. In an exemplary application, thebone plate40 can be positioned so that thebone facing surface230 is made to interface with a bone. Additionally, thebody210 has a length defining a central longitudinal axis L and one or more widths W₁, W₂, and W₃defining an extent of the body210 (and thus the bone plate40) transverse to the central longitudinal axis L. Although thebone plate40 is illustrated as lying in a single plane along the axis L, in other embodiments thebone plate40 can include curvature or bending of thebody210 along or around the axis L such that thebody210 of thebone plate40 does not lie in a single plane.
• Thebody210 may includeregions240A,240B,240C, and240D extending from thetop surface220 to thebone facing surface230, and which can be spaced from one another along theaxis L. Regions240A,240B,240C, and240D can each extend a distance along the axis L from aregion leading edge240A_L,240B_L,240C_L, and240D_Lto aregion trailing edge240A_T,240B_T,240C_T, and240D_T, respectively. The width W₁can correspond to a width of thebody210 at eachregion240A,240B,240C, and240D, and in the illustrated embodiment the width W₁is the greatest extent of thebody210 transverse to the axis L.
• As shown for example inFIG. 2F,region240B has anouter shape250 that links thetop surface220 and thebone facing surface230. Theouter shape250 may be any type of contour atregion240B that reduces stress or increases strength of thebone plate40. Theouter shape250 can also be used to minimize soft tissue irritation and increase bone healing during application of thebone plate40. In the illustrated embodiment, theouter shape250 includes a rounded edge contour that can increase strength for bending of thebone plate40, reduce stresses in thebone plate40 for improving the useful life of thebone plate40, and reduce soft tissue irritation and increase bone healing when thebone plate40 is utilized.Regions240A,240C, and240D can also includeouter shapes250.
• Included at theregions240A,240B,240C, and240D can befixation holes260A,260B,260C, and260D, respectively. Fixation holes260A,260B,260C, and260D extend through thebody210 atregions240A,240B,240C, and240D, respectively, from thetop surface220 to thebottom surface230. Fixation holes260A,260B,260C, and/or260D may be configured to receive fasteners, such asbone plate fasteners60. For example, holes260A,260B,260C, and/or260D can be threaded to threadingly engagebone plate fasteners60. As a result, the fixation holes260A,260B,260C, and260D may serve as a location for fixing thebone plate40 to a bone.
• In the illustrated embodiment thebone plate40 has fourregions240A,240B,240C, and240D and fourfixation holes260A,260B,260C, and260D, but in other embodiments any number of regions and fixation holes can be included regardless of whether a particular region also includes a fixation hole. Additionally, theregions240A,240B,240C, and240D on thebody210 are shown as rounded, but in other embodiments theregions240A,240B,240C, and240D can have various other geometries. Where theregions240A,240B,240C, and240D are rounded, in one embodiment one or more of theregions240A,240B,240C, and/or240D may have a radius of curvature between about 2.7 mm and about 3.0 mm (e.g., 2.9 mm). Moreover, although theregions240A,240B,240C, and240D are illustrated to be of similar sizes, theregions240A,240B,240C, and240D can also be of varying sizes. For example, one region can include the width W₁while another region may have its greatest width less than the width W1, or greater than the width W₁.
• Located on thebone facing surface230 at aregion240A,240B,240C, or240D can be apad270 that extends outward a distance from a first surface274 (labeled inFIGS. 2C-D). In the embodiment shown, thefirst surface274 is included on aregion276A that includes the thinnest cross-section of thebone plate40. One or moreadditional regions276B-E may be provided, each having thefirst surface274 at generally the same elevation. In one application, thepad270 can extend outward from thefirst surface274 in a direction that is generally perpendicular to thefirst surface274, but in other applications thepad270 can extend out from thefirst surface274 at various angles. In one example, thepad270 extends outward about 0.3 millimeters to about 0.5 millimeters (e.g., about 0.42 millimeters) relative to thefirst surface274. For instance, where thepad270 extends out perpendicular to the surface274 a ratio of a thickness of thebone plate40 including thepad270 to a thickness of thebone plate40 at thefirst surface274 can be between approximately 1.01 and 1.5 (e.g., about 1.3).
• Thus, thepad270 can be a point of contact with a bone on thebone facing surface230 when thebone plate40 is configured to interface with the bone. As shown, thebone facing surface230 of thebone plate40 includes apad270 at each of theregions240A,240B,240C, and240D such that thepads270 are adjacent the fixation holes260A,260B,260C, and260D at the respective regions. In the illustrated embodiment, thepads270 extend a length along the axis L from eachregion leading edge240A_L,240B_L,240C_L, and240D_Lto eachregion trailing edge240A_T,240B_T,240C_T, and240D_T, respectively. Thepads270 as shown also extend from a first end of the width W₁of thebody210 to a first point on a perimeter of the fixation holes260A,260B,260C, and260D nearest the first end of the width W₁, and from a second end of the width W₁, located opposite the first end of the width W₁, of thebody210 to a second point on the perimeter of the fixation holes260A,260B,260C, and260D nearest the second end of the width W₁. Thus, in the embodiment shown thepads270 do not span an entire width, including width W₁, of theregions240A,240B,240C, and240D on thebone facing surface230. In some embodiments, the sum total of the surface area of the pads on a bone plate is less than 50% of the total surface area of the bone plate. Although the embodiment ofbone plate40 shown includes thepads270 adjacent the fixation holes260A,260B,260C, and260D, any number of thepads270 can be included at various locations on thebone facing surface230 and the geometries of thepads270 can vary according to the particular application of thebone plate40.
• The span of thepads270 along the width of theregions240A,240B,240C, and240D is interrupted in the embodiment ofbone plate40 bychannels280 in thepads270 at each of theregions240A,240B,240C, and240D. In the embodiment shown, thechannels280 extend outward a distance from thefirst surface274, but in other embodiments thechannels280 can be flush with thefirst surface274. In embodiments where one ormore channels280 do extend out a distance from thefirst surface274, the distance these one ormore channels280 extend out is less than the distance thepads270 extend out from thefirst surface274. In such embodiments, thepads270 are raised relative to thechannels280, and thechannels280 are elevated relative to thefirst surface274, as shown inFIG. 3B. Thechannels280 may extend a length along the axis L on thebone plate40 from eachregion leading edge240A_L,240B_L,240C_L, and240D_Lto eachfixation hole260A,260B,260C, and260D of the respective region and from eachfixation hole260A,260B,260C, and260D to each respectiveregion trailing edge240A_T,240B_T,240C_T, and240D_T. Thechannels280 may also extend a width along the width of eachregion240A,240B,240C, and240D between thepads270. As such, in the illustrated embodiment fixation holes260A,260B,260C, and260D interface with thepads270 or thechannels280 at all locations along the perimeters of the fixation holes260A,260B,260C, and260D. As shown, eachchannel280 included at eachregion240A,240B,240C, and240D is aligned along the axis L with thechannels280 at each other region.
• At locations where thechannel280 interfaces with thepad270, aradiused surface290 can be included to transition from thechannel280 to thepad270. For example, theradiused surface290 can have a continual slope from the raisedpad270 to the relativelylower channel280. Theradiused surface290 may act, for example, to reduce stresses in thebone plate40, and therefore can be useful for applications of thebone plate40 where a greater strength is desired.
• Including one ormore pads270 and/or one ormore channels280 can provide benefits during application of thebone plate40. For instance, including apad270 and/or achannel280 on thebone facing surface230 may decrease trauma to a periosteal membrane of a bone when thebone plate40 is attached to a bone in a surgical procedure. Decreasing trauma to the periosteal membrane of the bone can result in less disruption of blood flow, which can help with healing the area of the bone interfacing with thebone plate40.
• Additionally, thepad270 and/orchannel280 can act to increase a bending strength of thebone plate40 without impeding bending of thebone plate40 in a desired location ofbone plate40. In certain embodiments, a desired location of bone plate bending includes at least one of theregions276A-E. In such embodiments, one or more of theregions276A-E can be configured to concentrate bending forces applied to thebone plate40. In a particular embodiment, such regions are configured to concentrate bending stresses by having a smaller minimum bending force required to bend the plate at the region compared to other regions of the plate. In the embodiment shown, the smaller minimum bending stress is provided by theregions276A-E having the thinnest cross-sections of the plate. Thus, this can allow thebone plate40 to be bent as desired for a particular application and anatomy without deforming any threads included in any of the fixation holes260A-D.
• Extending along the axis L betweenregions240B and240C, and forming part of thebody210, can be abridge300. Thebridge300 may define a portion of thebody210 having a width W₂. In the exemplary embodiment of thebone plate40 shown, the width W₂along thebridge300 can be less than the width W₁included atregions240A,240B,240C, and240D, but in other embodiments thebridge300 can have widths W₂equal to or greater than the width W₁. Thebridge300 as illustrated has sides running parallel to the axis L that are generally linear, but for other embodiments of thebone plate40 thebridge300 can have rounded sides similar to theregions240A,240B,240C, and240D or any other geometry suited for the specific application of thebone plate40. In some embodiments, thebridge300 is devoid of any apertures and extends between regions having fixation holes, such asregions240B and240C havingfixation holes260B,260C, respectively.
• On thebone facing surface230, thebridge300 may include one ormore pads310. The one ormore pads310 can be similar to thepad270, such that the one ormore pads310 extend outward from thefirst surface274. Also on thebone facing surface230, thebridge300 can have one ormore channels320 included along the width W₂between thepad310. The one ormore channels320 can be similar to thechannel280. In the embodiment shown, thechannels320 extend outward a distance from thefirst surface274, but in other embodiments thechannels320 can be flush with thefirst surface274. In embodiments where one ormore channels320 do extend out a distance from thefirst surface274, the distance these one ormore channels320 extend out is less than the distance thepads310 extend out from thefirst surface274. In such embodiments, thepads310 are raised relative to thechannels320, and thechannels320 are elevated relative to thefirst surface274, as shown inFIG. 2D. In one exemplary application, the one ormore channels320 can be aligned with thechannels280 along the axis L. Further, the one ormore channels320 can extend outward the same distance as thechannels280 from thefirst surface274. In addition, the one ormore channels320 can have the same width as thechannels280. Any of these embodiments can result in a continuous channel that is formed at all locations on thebone facing surface230 along the axis L having apad270 or310.
• Thebridge300 as shown has twopads310, thefirst pad310 bordered byregions276B and276C, and thesecond pad310 bordered byregions276C and276D, eachpad310 having achannel320 located along the width W₂between thepad310, spaced along the axis L. In other embodiments of thebone plate40 thebridge300 can include any number and configuration ofpads310 andchannels320. Thepads310 andchannels320 may serve similar functions to those described with respect to thepads270 andchannels280. Further,regions276B-D can be configured as desired bending regions as described above forregions276A and E.
• Extending along the axis L betweenregions240A and240B as well as betweenregions240C and240D arebranches330. Thebranches330 form a portion of thebody210 that connects theregion240A to theregion240B as well as theregion240C to theregion240D. Thebranches330 have a width W3. The width W3 of thebranches330 as illustrated in less than the width W₁and W₂, but in other embodiments the width W3 can be equal to or greater than the width W₁and/or the width W₂. Thus, for thebone plate40 illustrated inFIGS. 2B-2F the width of thebody210 is greatest at theregions240A,240B,240C, and240D and least atbranches330. Thebranches330 as shown have sides running parallel to the axis L that are generally linear, but for other embodiments of thebone plate40 thebranches330 can have rounded sides similar to theregions240A,240B,240C, and240D or any other geometry suited for the specific application of thebone plate40. In the embodiment shown, the branches include thefirst surface274 and coincide withregions276A and276E.
• FIGS. 2G and 2H show a side elevational view and a perspective view, respectively, of thebone plate40. Although thebone plate40 is referenced for illustrative purposes here, this discussion can apply to all bone plate embodiments of various shapes. InFIG. 2G, thebone plate40 has been positioned such that thebone facing surface230 is facing abone340. As thebone plate40 is moved closer to thebone340, thepads270 and310 can come into contact with thebone340. Contacting thebone340 with thepads270 and310, as opposed to contacting thebone340 with thebone facing surface230 in general, can help to decrease trauma to the periosteal membrane of thebone340 to allow for increased blood flow for healing. Thebone plate40 may also be positioned such that thebridge300 extends across atarget area345. In the illustration ofFIG. 2G, thetarget area345 is depicted as a fracture of thebone340. However, in other applications positioning thebridge300 across thetarget area345 may include positioning thebridge300 across a joint between two bones, such as a metatarsal-cuneiform joint, or across other areas needing bone fixation at adjacent locations. Positioning thebridge300 of thebone plate40 across thetarget area345 can help increase the strength and healing of thebone340.
• Thebone plate40 as shown hasattachment members350 configured at least partially within the fixation holes260A,260B,260C, and260D. For example, where the fixation holes260A,260B,260C, and260D are threaded, theattachment members350 can also be threaded so as to be attached within the fixation holes260A,260B,260C, and260D. Theattachment members350 can be utilized, for example, to assist in locating and aligning various surgical tools and reamers and/or bending thebone plate40 to better align with a contour of thebone340 or other anatomy. For instance, it may be necessary to bend thebone plate40 so that each of thepads270 and310 is in contact with thebone340. Theattachment members350 can be, for example, cylindrical along an axial length of themembers350 and include apertures that are aligned with therespective fixation holes260A,260B,260C, and260D. As shown, theattachment members350 have an elongated aperture, relative to the fixation holes260A,260B,260C, and260D, that can help align tools and/or drill bits used during various applications of thebone plate40 in surgical procedures. Also, the extension of theattachment members350 out from thetop surface220 can allow for greater leverage for bending thebone plate40.
• Althoughbone plate40 can have a variety of different configurations, in some applications, the bone plate has a helical curvature extending between opposed fixation holes. The helical curvature can cause fixation hole(s) positioned in a distal section of the bone plate to be positioned in a different plane than fixation holes(s) positioned in a proximal section of the bone plate. For example, the helical curvature may follow a path traced along an imaginary cylinder or cone at an oblique angle so as to define a spiral or curved fold. In some examples, the angle and/or extent of curvature may be formed or adjusted in-situ by fabricating the bone plate out of a malleable material. The helical curvature of the bone plate may be configured to extend from the plantar region of a first metatarsal to the medial region of a medial cuneiform, thereby positioning the curvature across a metatarsal-cuneiform joint.
• FIGS. 2I and 2J illustrate different perspective views of an embodiment ofbone plate40 that can be included inkit10, where the bone plate has a helical curvature. As shown, thebone plate40 defines abody42 having atop surface44 and abone facing surface46, where thebone facing surface46 is on a side of thebody42 opposite thetop surface44. In an exemplary application, thebone plate40 can be positioned so that thebone facing surface46 interfaces with and/or is in contact with a bone. In the example shown inFIGS. 21 and 2J, thebone facing surface46 includes multiple surfaces projecting different distances away fromtop surface44. Thus, for convenience, “bone facing surface” will refer to the side of the bone plate generally facing bone when the plate is positioned on a bone, regardless of whether there is more than one surface and regardless of whether each surface is in contact with the bone whenbone plate40 is applied.
• Thebody42 of thebone plate40 has a major length which defines the central longitudinal axis L. Thebody42 can include aproximal region48 at or near a first longitudinal end and adistal region52 at or near a second longitudinal end that is opposite the first longitudinal end of thebone plate40. Theproximal region48 may be separated from thedistal region52 by an intermediate region. For example, thebody42 may include one or more fixation holes. In these examples,body42 may include one or more fixation holes inproximal region48, one or more additional fixation holes indistal region52, and an intermediate region devoid of fixation holes positioned betweenproximal region48 anddistal region52.
• In the illustrated embodiment, thedistal region52 has at least one fixation hole, which is illustrated as twofixation holes60A and60B, and theproximal region48 has at least one additional fixation hole, which is illustrated as twofixation holes60C and60D. In other examples,body42 may include fewer fixation holes (e.g., one, none) or more fixation holes (e.g., three, four) inproximal region48 and/ordistal region52. Moreover, the dimensions (e.g., length) of the proximal anddistal regions48,52 can be adjusted to accommodate the particular number of fixation holes included.
• In the example shown, theproximal region48 extends longitudinally from the first longitudinal end of thebone plate40 to an end of thefixation hole60C on the axis L furthest from the first longitudinal end. In addition, in this example, thedistal region52 extends longitudinally from the second longitudinal end of thebone plate40 to an end of thefixation hole60B on the axis L furthest from the second longitudinal end. Thus, in the illustrated example, thebone plate40 includes a region betweenproximal region48 anddistal region52, specifically between the terminal edge offixation hole60B and the terminal edge offixation hole60C, which is devoid of fixation holes and is sometimes referred to herein as a “bridge.”
• As shown inFIGS. 21 and 2J, thebody42 of thebone plate40 can include ahelical curvature62. Such a helical curvature can include a curve that resides in three-dimensional space. In some embodiments, thedistal region52 lies in a first plane and theproximal region48 lies in a second plane different from, and offset from, the first plane both along and about the longitudinal axis L. Depending on the extent of the bend and/or twist of thehelical curvature62 desired for a particular application, the first plane including thedistal region52 and the second plane including theproximal region48 can be substantially perpendicular about the longitudinal axis. In some embodiments, the radius of the helical curvature can vary as a function of longitudinal position on thebody42. In other embodiments, the radius of the helical curvature can be constant as a function of longitudinal position on thebody42.
• In the embodiment of thebone plate40 shown inFIGS. 2I and 2J, thehelical curvature62 includes both a bend along the central longitudinal axis L (e.g., around an axis perpendicular to axis L) and a twist about the axis L. The bend may curve theproximal region48 of thebody42 back toward thedistal region52 of the body about an intermediate bridge section between regions55B and55C. For example, the bend can reduce the distance between opposite end ofbody42 as compared to whenbody42 is flat or planar. The radius of the bend can vary or be constant as a function of longitudinal position on thebody42, and/or be concentrated in one or more portions of thebody42, such as the portion of the body between the proximal and distal portions. In some examples, the bend ranges from approximately 10° to approximately 45°, such as from approximately 15° to approximately 35°. In other examples, the bend ranges from 45° to 135°, such as from approximately 75° to approximately 105°. Other angles of bend are also possible.
• The twist ofhelical curvature62 about longitudinal axis L can rotate the proximal region ofbody42 relative to thedistal region52 about axis L. For example, the twist may rotate regions55C and55D relative to regions55A and55B such that regions55C and55D, and the corresponding fixation holes defined therein, are radially offset from regions55A and55B, and the corresponding fixation holes defined therein. In some embodiments, the twist is concentrated in one or more portions of thebody42, such as the portion of the body between the proximal and distal portions. Further, in some examples, the twist of thebody42 ranges from approximately 45° to less than 180° about the axis L, such as from approximately 60° to approximately 100° about the axis L, or from approximately 70° to approximately 90° about the axis L. In other examples, the twist of thebody42 ranges from 25° to 100°, such as from 35° to 65°. Other angles of twist are also possible depending on the application.
• While thebone plate40 is described as havinghelical curvature62, it should be appreciated that the curvature provided by the bone plate need not be a mathematically perfect helix. Rather, thehelical curvature62 may be a generally helical shape, such as a shape that follows the general contours of a helix even if the angles of contortion do not form a perfect helix. Therefore, it should be appreciated that a bone plate described as having a helical curvature according to the disclosure may, in practice, have a generally helical shape without forming a mathematically perfect helix. Additional bone plate details can be found in U.S. patent application Ser. No. 14/990,368, filed Jan. 7, 2016, the entire contents of which are incorporated herein by reference.
• In some embodiments, thehelical curvature62 can be concentrated or entirely within a region of thebody42 between theproximal region48 anddistal region52. Thus, any bend of thebody42 along the axis L and any twist of thebody42 about the axis L of thehelical curvature62 can begin at or near an end of the distal region52 (e.g., begin at oradjacent fixation hole60B) and proceed in a proximal direction toward the proximal region48 (e.g., terminating at oradjacent fixation hole60C). For instance, the helical curvature62 (e.g., the bend along the axis L and the twist about the axis L) of the illustrated embodiment begins at the end of thedistal region52 and ends at the beginning of theproximal region48. Thus, thehelical curvature62 as shown is located on a bridge portion of thebody42 between the fixation holes60B and60C. In such embodiments, thehelical curvature62 provides the transition of thebody42 from the first plane to the second plane. Moreover, in this embodiment,fixation holes60A and60B are positioned in the same plane,fixation holes60C and60D are also positioned in the same plane, and theplane fixation holes60A and60B are positioned in is offset from theplane fixation holes60C and60D are positioned in byhelical curvature62.
• Thehelical curvature62 can be included on thebone plate40 so as to provide a twist and/or bend suitable for a particular application, e.g., such as facilitating positioning of the bone plate across a tarsal-metatarsal joint. In some examples,helical curvature62 includes a twist of approximately 90° about the longitudinal axis of a bone (and the axis L of the bone plate40). Thehelical curvature62 also includes a bend along the axis L of thebone plate40.
• In some embodiments, thehelical curvature62 of thebone plate40 is pre-formed, such that the bone plate includes the helical curvature when it is removed fromkit10. For example,helical curvature62 may be formed inbone plate40 before placing inkit10, and the bone plate may be sufficiently rigid to hold the helical curvature until use. In some additional embodiments of thebone plate40,body42 can include malleable materials that allow for in-situ bending of thehelical curvature62. In still other embodiments, the bone plate may contain a pre-formedhelical curvature62 yet be formed of malleable materials such that the bone plate can be further bent during a surgical procedure. This can allow a clinician to adjust the radius of curvature and/or amount of bend ofhelical curvature62 during a procedure to best fit the particular anatomy and/or patient undergoing the procedure (e.g., depending on the dimensions of the bones to which thebone plate40 is to be fixed). For example, a clinician may remove thebone plate40 fromkit10 and then bend the bone plate betweenproximal region48 anddistal region52 until the shape of thehelical curvature62 best matches the anatomy across which thebone plate40 is being positioned. In applications wherebone plate40 includes a pre-formedhelical curvature62, the amount of bending provided by the clinician may range from plus 20° (making thebody42 flatter) to minus 20°, such as from plus 10° to minus 10°, or from plus 5° to minus 5°, although other degrees of bending may also be used depending on the application.
• In some embodiments, thekit10 includes at least one and no more than fourbone plates40, with the exact number ofbone plates40 included in thekit10 varying depending on the specific surgical procedure for which thekit10 is configured to be used. For example, in some surgical procedures the bone plates are aligned with respect to the bone such that they reside in different planes. For example, two bone plates can be attached to a bone with the two bone plates positioned about 90 degrees, with respect to each other, along the outer circumference of the bone (e.g., left side and top, or top and right side). In certain surgical procedures, the longitudinal axes of the bone plates can be substantially parallel. This can, for instance, be beneficial for providing a strong fixation with respect to more than one plane.
• FIG. 3 shows a perspective view of the embodiments of theplate manipulation instruments80 shown and described as included in thekit10 with respect toFIG. 1. Theplate manipulation instruments80 can have afirst end360 and asecond end370. In the illustrated embodiment, thefirst end360 is at an angle relative to thesecond end370. At least a portion of thefirst end360 can include a friction surface so as to facilitate, for example, gripping at or near thefirst end360 by, for example, a surgeon. Thesecond end370 may be configured so as to be insertable within the attachment member350 (shown, e.g., inFIG. 2G). Whereattachment members350 are not present, thesecond end370 may be configured so as to be insertable within the fixation holes260A-D (shown, e.g., inFIG. 2B) of thebone plate40. Inserting thesecond end370 into the attachment member350 (orfixation holes260A-D) can allow thebone plate40 to be bent or otherwise altered in geometry so as to substantially match a contour of a bone to which thebone plate40 is to be fixed. The angle at which thesecond end370 is disposed with respect to thefirst end360 can facilitate bending thebone plate40 by providing leverage complimentary to the force applied at the grippedfirst end360.
• In addition to thesecond end370 being configured so as to alter the geometry of thebone plate40, thesecond end370 can also be configured so as to drive one or more of thebone plate fasteners60. This can allow thekit10 to be more compact where desired. For example, thesecond end370 may include atip375 that is configured to mate with the head160 of thebone plate fastener60. As such, thetip375 can be used to drive thebone plate fastener60 received within one of the fixation holes260A-D into a bone. In addition, in some embodiments, thetip375 can be configured so as to drive one or more of theexternal fasteners150 into a bone at a location spaced from thebone plate40. Further, thetip375 may be configured to mate with the attachment members to rotationally connect or remove the attachment members from the bone plate.
• FIG. 4 shows a perspective view of the embodiments of thedriver members100 shown and described as included in thekit10 with respect toFIG. 1. Thedriver members100 can have afirst end380 and asecond end390. Thedriver member100 can be gripped at or near thefirst end380, while thesecond end390 can be configured so as to mate with the head160 of thebone plate fastener60 and/or thehead180 of theexternal fastener150, for instance, via atip395. As a result, thedriver member100 can be used to drive thebone plate fastener60 received within one of the fixation holes260A-D into a bone to fixate thebone plate40 and/or drive theexternal fastener150 into a bone (at a location spaced from the bone plate40) to fixate the bone. In embodiments where theplate manipulation instrument80 is not included in thekit10, thedriver member100 can also be used to bend thebone plate40 similar to that described for theplate manipulation instrument80. Further, thetip395 may be configured to mate with the attachment members to rotationally connect or remove the attachment members from the bone plate. This may allow thekit10 to be more compact.
• FIG. 5 shows a perspective view of an alternative embodiment ofdriver members400. Instead of thedriver member100, thekit10 may instead include at least one and no more than threedriver members400. Similar to thedriver members100, thedriver members400 can have afirst end410, at or near which thedriver member400 can be gripped, and asecond end420 configured so as to mate with the head160 of thebone plate fastener60 and/or thehead180 of theexternal fastener150, for instance, via atip425. Additionally, where theplate manipulation instrument80 is not included in thekit10, thedriver member400 can also be used to bend thebone plate40 similar to that described for theplate manipulation instrument80. Further, thetip425 may be configured to mate with the attachment members to rotationally connect or remove the attachment members from the bone plate.
• FIG. 6 illustrates a perspective view of the bone cut pins120 shown and described as included in thekit10 with respect toFIG. 1. The bone cut pins120 may have afirst end430 and asecond end440 having an end portion that can include apoint445, which may be fluted for cutting bone. In one application, thebone cut pin120 can have thepoint445 inserted through onefixation hole260A-D of thebone plate40 so as to contact the bone. Thepoint445 may be used to create an initial pilot hole in the bone at a location aligned with thefixation hole260A-D. This initial pilot hole can then be used as a location where thebone plate fastener60 is to be fixed to the bone after being received in thefixation hole260A-D. Furthermore, the bone cut pins120 can be of varying lengths. As illustrated, one of the bone cut pins120 is longer than the others. The difference in length of the bone cut pins120 can serve to prevent interference caused by theends430 to other surgical instruments used in a similar or proximate location.
• A collar, sometimes referred to as an olive450, can be included on thebone cut pin120 at a location spaced from thepoint445 as well as thesecond end440. Thecollar450 can have a diameter greater than a diameter of thepoint445, and it can act as a depth gauge structure. As a result of the larger diameter of thecollar450 relative to thepoint445, thetip445 and end440 cannot be inserted into the bone any further than the surface of thecollar450 nearest theend440. Thus, thecollar450 can serve as a stopping point along a longitudinal axis of thebone cut pin120. As such, the exact location of thecollar450 on thebone cut pin120 can vary depending on the desired depth of penetration of theend440 into the bone. Additionally, thecollar450 can serve as means to measure a depth of penetration of thetip445 into the bone while creating the initial pilot hole.
• FIG. 7 shows a perspective view of bone fixation pins460. Although not shown in the embodiment of thekit10 described with respect toFIG. 1, at least one and no more than four bone fixation pins460 can be included in various embodiments of thekit10. Eachbone fixation pin460 can have afirst end470 and asecond end480 which may include a threaded portion as illustrated. Acollar490 can be included at a location on one or more of the bone fixation pins460 spaced from theend480 and serve a function similar to that described with respect tocollar450 ofFIG. 6.
• Bone fixation pins460 can be used to fix one or more bones in a particular position as desired for a surgical procedure. The bone fixation pins460 can be used to fix one or more bones independent of and at a location spaced from thebone plate40. For instance, the threaded portion of theend480 of onebone fixation pin460 can be inserted into a bone in a manner that fixes the bone in the desired position. In some procedures, one or more additional bone fixation pins460 can also be inserted into the same bone or one or more adjacent bones such that the one or more bones are appropriately fixed as desired. This can facilitate greater accuracy during a surgical procedure. For example, at least one bone fixation pin may be inserted into adjacent bones, crossing the joint space between the bones, and used to compress the bones together prior to the installation of a bone plate.
• FIG. 8 illustrates a perspective view of an embodiment of a single external fastenerbone cut pin500. Although not shown in the embodiment of thekit10 described with respect toFIG. 1, where an embodiment of thekit10 includes the external fastener150 (shown and described with respect toFIG. 2A) thekit10 can further include the single external fastenerbone cut pin500 and no other external fastener bone cut pins. In embodiments where the external fastener has a diameter different than a diameter of a bone plate fastener, the single external fastener bone cut pin can be sized to accommodate the diameter of the external fastener. The external fastenerbone cut pin500 may have afirst end505 and asecond end510. At thesecond end510 can be apoint515. The external fastenerbone cut pin500 can be used to create an initial pilot hole for theexternal fastener150 via thepoint515 at a location on a bone where theexternal fastener150 is to be inserted.
• In addition to the surgical items described previously, embodiments of thekit10 may further include a bone preparation instrument that can be disposed after use on a single surgical patient. The bone preparation instrument can be useful during a surgical procedure to position and/or cut one or more bones. In some embodiments, the kits include only two or fewer (e.g., one) bone preparation instruments. Several embodiments of such instruments will be described in turn below.
• FIGS. 9A and 9B show a first embodiment of abone preparation instrument520.FIG. 9A shows a perspective view of thebone preparation instrument520 with some components shown in an exploded view, whileFIG. 9B shows a perspective view of thebone preparation instrument520 assembled. Additional discussion of exemplary instruments and techniques that can be included in, or used with,kit10 are provided in U.S. patent application Ser. No. 14/981,335, filed Dec. 28, 2015, and 62/293,189, filed Feb. 9, 2015, the entire contents of which are incorporated herein by reference.
• With reference toFIGS. 9A and 9B, thebone preparation instrument520 can include asupport530 which defines aninner cavity540. In one embodiment, thesupport530 can include afirst fixation aperture550A and asecond fixation aperture550B, each of which can extend through thesupport530 and receive bone preparation fixation pins140A and140B, respectively, such that the fixation pins140A and140B extend through thesupport530 via thefixation apertures550A and550B. In the embodiment shown, the fixation pins140A and140B have a threaded first end adapted to threadingly engage with a bone, and allow thesupport530 to be translated along a longitudinal axis of bothpins140A and140B. In the illustrated embodiments, thefixation apertures550A and550B are located on opposite longitudinal ends of thesupport530, but in other embodiments thefixation apertures550A and550B can be located at various positions on thesupport530. Thesupport530 can further include one ormore extensions570A and/or570B protruding generally radially out from thesupport530, which may define a concave surface configured to receive a generally cylindrical bone portion. In the embodiment shown,fixation aperture550B is provided with anextension member572 which can be threadingly coupled to thesupport530. Such anextension member572 can be adjusted relative to thesupport530 to allow the support to become parallel with a longitudinal axis of a bone, if desired. In such embodiments, thesupport530 can rest on a bone via theextensions570 A/B andextension member572 in a position generally parallel to the bone.Fixation pin140B may be received within an internal aperture of theextension member572.Aperture574A (and aperture574B, not shown, on an opposite side of thesupport530 fromaperture574A), such as tapered apertures, may be provided proximal toextension570A (and570B). Such apertures may extend through the support at a skewed angle relative to the longitudinal axis of the support, and may be used to engage a clamping instrument or receive fixation pins.
• Thesupport530 can also include aslot580 formed on at least a portion of a surface of thesupport530. As illustrated in the embodiment of thebone preparation instrument520 shown inFIG. 9B, theslot580 can extend in a surface of thesupport530 betweenfixation apertures550A and550B. A securingcomponent590 can be configured to translate along theslot580 relative to thesupport530. For example, the securingcomponent590 can have a first end with a diameter greater than a diameter of a second opposite end, such that the first end of the securingcomponent590 is supported by the slot580 (i.e. the first end has a diameter greater than a radial width of the slot580) while the second end of the securingcomponent590 is positioned within the slot580 (i.e. the second end has a diameter less than a radial width of the slot580).
• Theinner cavity540 of thesupport530 can have ashaft600 positioned at least partially within theinner cavity540. Theshaft600 can be configured so as to translate within theinner cavity540 relative to thesupport530, such that an end of theshaft600 can be made to project out from theinner cavity540. Theshaft600 may define aslot605 which may be aligned with theslot580 defined by thesupport530. Thisslot605 may receive thepin140A to reduce interference when theshaft600 translates. Furthermore, theshaft600 can include a securingaperture610 which can be configured to receive at least a portion of the securingcomponent590. In one embodiment, both the second end of the securingcomponent590, within theslot580, and the securingaperture610 can be threaded to allow thesecuring component590 to mate with the securingaperture610. Such a configuration can allow theshaft600 to be fixed, such as by compressing a surface of thesupport530 that defines theslot580, and thus prevented from translating within theinner cavity540, relative to thesupport530. In another embodiment, the securingcomponent590 can be threadingly engaged with thesupport530 to act against theshaft600 to prevent theshaft600 from traveling with thecavity540 when desired.
• On an end of theshaft600, amain guide member620 can be disposed. In some embodiments themain guide member620 can be integral with theshaft600, or in other embodiments themain guide member620 and theshaft600 can be separate components coupled together. Themain guide member620 can have afirst guide surface630A and asecond guide surface630B, and in some embodiments themain guide member620 can includeblocks640A and/or640B. The first and second guide surfaces630A and630B can be adjacent surfaces facing one another with a space defined between the first and second guide surfaces630A and630B. For example, thefirst guide surface630A can be a surface of themain guide member620 immediately opposite a surface of themain guide member620 that interfaces with theshaft600, and thesecond guide surface630B can be a surface of themain guide member620 immediately opposite a surface of themain guide member620 that includesblocks640A and640B. In the illustrated embodiment, thesecond guide surface630B contains a gap, such that thesecond guide surface630B is not a single, continuous surface. In other embodiments, thesecond guide surface630B can be a single, continuous surface lacking any such gap. Thefirst guide surface630A defines a first plane, while thesecond guide surface630B defines a second plane. As shown, thefirst guide surface630A and thesecond guide surface630B can be configured such that the first plane is parallel to the second plane, with the space between. In further embodiments (not illustrated), the guide surfaces630A and630B can be configured such that the first and/or second planes are skewed.
• As previously noted, a surface of themain guide member620 can include one ormore blocks640A and640B, either integral with themain guide member620 or as separate components attached to themain guide member620. As shown, theblocks640A and640B can be on a surface on a side of themain guide member620 furthest from the interface with theshaft600. In other applications, theblocks640A and640B can be located at various other positions on themain guide member620. Theblocks640A and640B can includefixation apertures650A and650B respectively. Thefixation apertures650A and650B extend through theblocks640A and640B and provide a location for configuring additional fixation pins (e.g. bone fixation pins460 shown in, e.g.,FIG. 7) to, for example, position a bone or bones.
• In addition to thesupport530, thebone preparation instrument520 can include abridge component660. As shown inFIG. 9B, thebridge component660 can attach to themain guide member620. In particular, in some applications of thebone preparation instrument520 thebridge component660 can have a geometry that allows thebridge component660 to attach to themain guide member620 between the first and second guide surfaces630A and630B through an interference fit. Optionally, a locking mechanism can be provided to lock the bridge component to the main guide member, such as a locking tab, screw, pin, cam, etc. For example, thebridge component660 may have a planar member665 (shown inFIG. 9A) that is received within the gap between thesurfaces630A and630B and an extending block666 (shown inFIG. 9A) adapted to extend into the surface gap of630B. In other applications, thebridge component660 can be coupled to themain guide member620 by any attachment mechanism, such as screws or clamps. Thebridge component660 can includerails670A and670B, each extending out from thebridge component660 in a same general direction. In other embodiments, therails670A and670B can extend out from thebridge component660 at different angles.
• Thebone preparation instrument520 can also include in some embodiments a fixatingstructure680. The fixatingstructure680 can be supported on therails670A and670B. For example, the fixatingstructure680 can includeapertures685A and685B to receive therails670A and670B, respectively. The fixatingstructure680 can be secured to therails670A and670B, such that the fixatingstructure680 is obstructed from translating along therails670A and670B, by turning or otherwise actuating anactuator686 of the fixatingstructure680, which moves a lock (not shown) to act against the rails. Furthermore, the fixatingstructure680 can also include one ormore fixation apertures690A and/or690B.Fixation apertures690A and690B extend through fixatingstructure680 and can be located on opposite ends of the fixatingstructure680, at a skewed angle, and serve to receive fixation pins or other means for stabilizing thebone preparation instrument520 across a targeted anatomy and/or positioning a bone or bones.
• Additionally, thebone preparation instrument520 can have asecondary guide member700. Thesecondary guide member700 can be supported on therails670A and670B. For example, thesecondary guide member700 may includeslots705A and705B to receive therails670A and670B such that thesecondary guide member700 is supported thereon. Thesecondary guide member700 can also have athird guide surface710A and afourth guide surface710B. The third and fourth guide surfaces710A and710B can be adjacent surfaces facing one another with a space defined between the third and fourth guide surfaces710A and710B. In the illustrated embodiments, third and fourth guide surfaces710A and710B are single, continuous surfaces that do not include a gap, but in other embodiments third and/or fourth guide surfaces710A and710B can include a gap. Thethird guide surface710A defines a third plane, while thefourth guide surface710B defines a fourth plane. As shown, thethird guide surface710A andfourth guide surface710B can be configured such that the third plane is parallel to the fourth plane, with the space between. In further embodiments (not illustrated), the guide surfaces710A and710B can be configured such that the third and/or fourth planes are skewed. Further, the third and/or fourth guide surfaces may be parallel to or skewed with respect to the first and/or second guide surfaces, such that the cutting guide can be adapted to make parallel cuts or angular cuts or cut shapes (e.g. a chevron shape). In some embodiments, thesecondary guide member700 can be locked to therails670A and/or670B with a locking screw, cam, pin, etc.
• In one application, thesecondary guide member700 can be supported on therails670A and670B at a location along therails670A and670B between the fixatingstructure680 and themain guide member620. Additionally shown inFIG. 9B are bone preparation fixation pins140C and140D received withinfixation apertures690A and690B such that the fixation pins140C and140D extend through the fixatingstructure680. In some applications of thebone preparation instrument520, it may be desirable to provide the fixation pins140C and140D at an angle other than 90 degrees relative to a top surface of the fixatingstructure680 by configuring thefixation apertures690A and690B to extend through the fixatingstructure680 at a skewed angle to guide the fixating pins140C and140D. Fixation pins140C and140D can be used, for example, for stabilizing thebone preparation instrument520 across a targeted anatomy and/or positioning a bone or bones.
• Embodiments of thebone preparation instrument520 can be useful in a surgical procedure for temporarily positioning a bone or bones and guiding a cutting of a bone or bones at a targeted anatomy. Bone cutting can be useful, for instance, to facilitate contact between leading edges of adjacent bones, separated by a joint, or different portions of a single bone, separated by a fracture, such as in a bone alignment and/or fusion procedure. Cuts can be made to bone with respect to the bone positioning instrument, and the bones can be positioned for an additional surgical step, such as bone plating, after the cuts have been made. As such, thebone preparation instrument520 can be used in methods for temporarily fixing an orientation of a bone or bones, such as during a surgical procedure, and guiding cutting at desired bone locations.
• Thesupport530 is placed on the bone. For embodiments of thebone preparation instrument520 that include theextensions570A and570B, theextensions570A and570B can be used to at least partially straddle the bone and consequently provide both greater stability to thesupport530 on the bone and anatomical alignment of thesupport530 on a longitudinal axis of the bone (e.g., theslot580 is generally parallel to the longitudinal axis of the bone).Extension member572 can be adjusted to a desired distance fromsupport530. Further, in some embodiments it can be desirable to align and fix thesupport530 along the longitudinal axis of the bone using the fixation pins140A and140B. Thepin140A can be inserted through thefixation aperture550A such that an end of thepin140A protrudes out from thefixation aperture550A adjacent the bone. Thepin140A can then be fixed to the bone. Similarly, thepin140B can be inserted throughfixation aperture550B and fixed on an end to the bone. In this manner, thesupport530 can be fixed in place to and aligned along the longitudinal axis of the bone.
• In addition to fixing thesupport530 to the bone, themain guide member620 can be aligned such that themain guide member620 is positioned at a location where a bone is to be cut. In one embodiment, themain guide member620 can be positioned at the location where a bone is to be cut by appropriately positioning and fixing thesupport530—thesupport530 is fixed to the bone at a location along the bone that results in themain guide member620 being positioned at the location where a bone is to be cut. In some embodiments, a joint alignment blade (not shown) is inserted though the main guide member and into a joint space to help align the main guide member in a desired position. Further, in certain embodiments, thebone fixation pin460 can be inserted through a bone of interest and into an adjacent bone (e.g., though a first metatarsal and into a second metatarsal) to provide additional stability during the procedure.
• However, in some applications a location of themain guide member620 relative to the longitudinal axis of the bone can be adjusted without necessitating movement of thesupport530. To accomplish this, theshaft600 at least partially within theinner cavity540 can be translated relative to thesupport530 to cause themain guide member620 to translate along the longitudinal axis of the bone a distance as a result of theshaft600 being moved the same distance. Once themain guide member620 is positioned at the location to be cut, the securingcomponent590 can be translated along theslot580 such that the securingcomponent590 is aligned with securingaperture610. The securingcomponent590 can then be fixed within the securingaperture610 such that theshaft600 is fixed relative to thesupport530.
• Once themain guide member620 has been positioned at the location to be cut, a cutting member (e.g. a saw blade) can be inserted through the space defined between thefirst guide surface630A and thesecond guide surface630B to cut the bone. The guide surfaces630A and630B can serve to direct the cutting member to the location of the bone to be cut, which in many applications can be a precise location. The break or window defined in thesecond guide surface630B can assist in visualizing the portion of the bone being cut.
• In some embodiments, themain guide member620 can be used to make additional cuts. In such embodiments, the securingcomponent590 can be loosened and theshaft600 can be translated within the cavity to a desired position. The securingcomponent590 can be then be fixed within the securing aperture so the shaft is again fixed relative to thesupport530. In some embodiments, fixation pins may be inserted throughfixation aperture650A and/or650B and into the bone to further stabilize themain guide member620. After themain guide member620 has been repositioned at the location to be cut, a cutting member (e.g. a saw blade) can be inserted through the space defined between thefirst guide surface630A and thesecond guide surface630B to cut the bone.
• As shown inFIG. 9B, once the bone has been cut the additional components of thebone preparation instrument520 can be added. In certain surgical procedures, it may be desirable to usebone preparation instrument520 to make a second cut the same or different bone as the first cut. Thesecondary guide member700 can be used to facilitate this second cut by positioning the secondary guide member at the location where the second cut is to be made. A cutting member (e.g. a saw blade) can be inserted through the space defined between the third and fourth guide surfaces710A and710B to cut the bone. The guide surfaces710A and710B can serve to direct the cutting member to the location on the bone to be cut. As illustrated, the cut made using thesecondary guide member700 will be a cut that is generally parallel to the cut made using themain guide member620. However, in other embodiments components of the bone preparation instrument520 (e.g. rails670A and670B) can be configured such that the cut made using thesecondary guide member700 is an angular cut (i.e. not parallel) relative to the first cut made using themain guide member620.
• When the bone or bones have been cut and positioned as desired on the single surgical patient, thebone preparation instrument520 can be removed and discarded using convention means.
• FIGS. 10A-C illustrate a second embodiment of abone preparation instrument720. Thebone preparation instrument720 can serve as a single bone preparation instrument included in embodiments thekit10 and be disposed after use on a single surgical patient.FIG. 10A shows a perspective view of thebone preparation instrument720,FIG. 10B shows a side elevational view of thebone preparation instrument520, andFIG. 10C shows another perspective view of thebone preparation instrument520.
• Thebone preparation instrument720 can include ablock725 having first and second side ends725A and725B as well as atop end725C and abottom end725D. Theblock725 can be made, for example, from a polymeric material. In the illustrated embodiment, theblock725 is shaped and dimensioned such that theblock725 is capable of being gripped by hand during a surgical procedure. For example, theblock725 may include arecess730 on one or more ends, such as theend725B as shown, to assist in gripping theblock725. However, in other embodiments theblock725 can have various shapes and dimensions.
• As shown inFIG. 10B, theblock725 can have one or moreguide attachment members740. For thebone preparation instrument720 as shown, the one or moreguide attachment members740 are included on theend725A of theblock725. In one embodiment, the one or moreguide attachment members740 can be fixed to theblock725 on an end of themembers740 nearest thetop end725C and free on an end of theattachment members740 nearest thebottom end725D. In such a configuration, the one ormore members740 can extend out from the end fixed to theblock725 in a direction that is generally parallel to an axis of theblock725 extending from thetop end725C to thebottom end725D. But in other configurations of theblock725 that include theguide attachment members740, themembers740 can be fixed at various positions on theblock725 and extend out from theblock725 at any angle. In the embodiment shown, themembers740 assume a cylindrical shape.
• Theblock725 can additionally include aprojection750 that extends out from an end, such as thebottom end725D as illustrated, of theblock725. In an exemplary application, thebottom end725D of theblock725 can be positioned so as to interface with, for instance, two bones while theprojection750 is configured to extend into a space defined between the bones (e.g. a joint between two bones, or a space between two bone portions of a fractured bone). As such, depending on the application of thebone preparation instrument720, theprojection750 may have awidth755 that is dimensioned so as to be able to fit into the space defined between bones as desired. As shown, the projection may assume the shape of a planar member having two surfaces separated by a distance. In the embodiment shown, the distance,755, is generally constant, and a leading edge of theprojection750 is provided with a wedge to facilitate insertion into a space. In other embodiments, the distance may vary from a narrower dimension near the leading region to a wider dimension near a proximal region.
• Thebone preparation instrument720 can also include one ormore guide members760 and/or770 positionable with respect to theblock725. Theguide members760 and770 may be made of an appropriate metal or any other suitable material. Theguide members760 and770 can each have aflange780 and asupport790. Theflange780 is connected to thesupport790, and in some embodiments theflange780 and thesupport790 can be one integral component.
• Eachflange780 may include afirst guide surface800A and asecond guide surface800B. The first and second guide surfaces800A and800B can be adjacent surfaces facing one another with a space defined in theflange780 between the first and second guide surfaces800A and800B. The space is useful for receiving a cutting instrument, such as a saw blade, and thesurfaces800A and800B are useful for holding the cutting instrument in a desired plane during a cutting operation. As shown, thefirst guide surface800A can be a surface of theflange780 immediately opposite a surface of theflange780 that connects to thesupport790, and thesecond guide surface800B can be a surface of theflange780 immediately opposite a surface of theflange780 that can interface with theblock725. In the illustrated embodiment, the guide surfaces800A and800B are both single, continuous surfaces lacking any gap. In some embodiments (not illustrated), a guide surface, for instance thesecond guide surface800B, can contain a gap such that the guide surface is not a single, continuous surface. Thefirst guide surface800A defines a first plane, while thesecond guide surface800B defines a second plane. As shown, thefirst guide surface800A and thesecond guide surface800B can be configured such that the first plane is parallel to the second plane, with the space (defined in the flange780) between. In further embodiments (not illustrated), the guide surfaces800A and800B can be configured such that the first and/or second planes are skewed. Although the guide surfaces800A and800B are shown to be on theflange780, in other embodiments theguide members760 and/or770 may have the guide surfaces800A and800B (and thus the space defined between the guide surfaces800A and800B) at various locations. For example, the guide surfaces800A and800B could be included as part of thesupport790, such that the space defined in theflange780 between the guide surfaces800A and800B would instead be defined in thesupport790.
• Thesupport790 of eachguide member760 and770 can include one ormore fixation apertures810A and/or810B. Thefixation apertures810A and810B extend through thesupport790. Each of thefixation apertures810A and810B can receive, for example, a bone preparation fixation pin that extends through thesupport790 at thefixation apertures810A and810B such that an end of the bone preparation fixation pin can be fixed to a bone. In the illustrated embodiment, thefixation apertures810A and810B are located on opposite ends of thesupport790. Specifically, thefixation apertures810A and810B as shown are located on opposite ends of a longitudinal axis of thesupport790 that extends perpendicular to theflange780, and thus the first and second guide surfaces810A and810B. However, in other embodiments thesupport790 can extend at various angles from theflange780 and the one ormore fixation apertures810A and810B can be positioned at various locations on theguide members760 and770 (e.g. the flange780).
• In some embodiments, theguide member760 and/or770 may be pivotally attached to theblock725 such that theguide member760 and/or770 can pivot with respect to theblock725. For example, in one embodiment, to pivotally attach theguide member760 and/or770 to theblock725 theguide member760 and/or770 may include anaperture820 to receive theguide attachment member740 of theblock725. The aperture may assume a cylindrical shape sized to mate with theattachment member740. In the illustrated embodiment, theaperture820 is included on an end of theflange780 adjacent the first and second guide surfaces800A and800B, but in other variations theaperture820 can be included at other locations on theguide member760 and/or770. Further, in some embodiments (not shown), theblock725 can include theaperture820 and theguide member760 and/or770 can include theattachment member740.
• In either configuration, theaperture820 can be aligned with theguide attachment member740, and theguide member760 and/or770 can be attached to theblock725 by mating theattachment member740 and theaperture820. In some embodiments, the pivotable connection allows for theguide member760 and/or770 to slide along theattachment member740 until theguide member760 and/or770 contacts a surface of theblock725. Theguide member760 and/or770 can be free at an end opposite an end that contacts theblock725, which can allow theguide member760 and/or770 to translate along theguide attachment member740 such that theguide members760 and770 may be at different elevations with respect to theblock725.
• In the manner described, theguide member760 and/or770 is attached to theblock725 in a way that allows theguide member760 and/or770 to independently pivot with respect to theblock725 and to independently translate with respect to theblock725. Theguide member760 and/or770 can be pivotally attached to theblock725 in numerous ways and at various locations on theblock725. For instance, as illustrated theguide members760 and770 are pivotally attached to theblock725 on thesame end725A of theblock725 and radially spaced from each other on thatend725A. In this configuration, theguide members760 and770 pivot about theblock725 at anend725A opposite anend725B of theblock725. Additionally, the embodiment shown has theguide members760 and770 configured to pivot with respect to theblock725 about parallel axes of rotation. However, in other variations theguide members760 and770 can be attached to theblock725 at numerous locations, such as onopposite ends725A and725B, and in various configurations.
• Depending on the location of the connections, separatebone preparation instruments720 may be provided for left-side and right-side anatomies (e.g., a preparation instrument for a left foot and a preparation instrument for a right foot). In the embodiment shown, thebone preparation instrument720 is configured for a left foot. In some embodiments, a bone preparation instrument configured for a right foot would be a mirror image of theinstrument720 configured for a left foot.
• FIG. 10C illustrates a perspective view of thebone preparation instrument720. In the illustrated embodiment, theguide members760 and770 are pivotally attached to theblock725. A location where a bone is to be cut can vary depending on the particular surgical procedure being performed on the single surgical patient. In some applications, theguide member760 and/or770 can be aligned at the location to be cut by appropriately positioning theblock725 such that the space defined between the guide surfaces800A and800B of theguide member760 and/or770 is located at the location to be cut.
• In some embodiments, it may be desirable to adjust the location of theguide member760 and/or770 relative to theblock725 so that theguide member760 and/or770 is aligned at the location desired to be cut. In the example shown inFIG. 10C, theguide member760 has been pivoted about theblock725 so that theguide member760 is appropriately aligned at the location to be cut. Specifically, theguide member760 has been pivoted about theblock725 so that the space defined between the guide surfaces800A and800B is positioned at the location desired to be cut. Similarly, theguide member770 has been aligned at a second location to be cut by pivoting theguide member770 about theblock725 so that the space defined between the guide surfaces800A and800B is positioned at the second location desired to be cut. Depending on the particular application, theguide members760 and770 can be pivoted about theblock725 to differing degrees. Therefore, by pivotally attaching theguide member760 and/or770 to theblock725, bone cuts can be made at a wide range of locations. Further, because theprojection750 can be positioned within a joint, a longitudinal axis of the cut can be generally parallel with the projection while the plane of the cut can be angularly adjusted relative to the projection as desired.
• As previously noted, theguide members760 and770 can be attached to theblock725 in a manner that allows theguide members760 and770 to translate with respect to theblock725, such as up and down along the respectiveguide attachment members740. Configuring theguide members760 and770 to translate with respect to theblock725 allows theguide members760 and770 to be positioned at differing elevations, such as differing elevations along theguide members740. This can be beneficial, for example, where theblock725 is positioned between two bones having differing elevations (i.e. differing heights). In such an application, theguide members760 and770 can translate with respect to the block725 (e.g. along the respective guide attachment members740) so that eachguide member760 and770 rests on the respective bone on each side of theblock725, even though the bone on each side of theblock720 has a different elevation.
• Additionally, configuring theguide members760 and770 to translate with respect to theblock725 can allow theblock725 to be removed, for instance from a space defined between bones, while theguide members760 and770 remain in place. In the embodiment of thebone preparation instrument720 shown, theguide members760 and770 are free at an end opposite an end that can contact theblock725. This may allow theblock725 to be pulled away from theguide members760 and770 without disturbing theguide members760 and770, which may provide more working room during a surgical procedure.
• During a surgical procedure thebone preparation instrument720 can be positioned at a space defined between two bones. In particular, this can, for instance, include positioning theblock725 at the space defined between the bones. For embodiments where theblock725 includes theprojection750, theblock725 can be positioned at the space defined between the bones such that theprojection750 extends into the space defined between the bones. Theprojection750 can, for example, assist in positioning and spacing the bones.
• After positioning thebone preparation instrument720, theguide members760 and/or770 can be aligned at the location(s) to be cut. Aligning theguide members760 and770 at the respective locations to be cut can include pivoting one or bothguide members760 and770, for example at theapertures820, about theblock725 as necessary. In addition, in some embodiments aligning theguide member760 and/or770 can include translating theguide member760 and/or770 relative to and along theblock725 such that an elevation of theguide member760 and/or770 can be adjusted, for instance, to match an elevation of the respective bones. Theguide members760 and770 can be aligned such that cuts made to the bones using therespective guide members760 and770 are parallel cuts, but in other embodiments theguide members760 and770 can be aligned such that the cuts made to the bones are at various angles relative to each other.
• Once theguide members760 and/or770 have been aligned at the respective locations to be cut, theguide members760 and/or770 can be fixed to the respective bones. In the illustrated embodiment, the bone preparation fixation pins (not shown) may be inserted through thefixation apertures810A and/or810B of theguide members760 and/or770 to fix theguide members760 and/or770 to the respective bones. An end of a bone preparation fixation pin can be inserted through, for example, thefixation aperture810B in thesupport790 such that the end of the bone preparation fixation pin is fixed to the respective bone.
• After aligning and fixing theguide members760 and/or770, theblock725 may be removed from the space defined between the bones. Theblock725 can be removed by pulling theblock725 away from the bones in a direction opposite the bones. As such, in embodiments where theblock725 includes theprojection750, theprojection750 can also be removed from the space defined between the bones by removing theblock725. In this manner, theblock725 can slide out from theguide members760 and770 while theguide members760 and770 remain fixed to the respective bones.
• The bones can be cut at the desired locations where theguide members760 and/or770 have been aligned. For example, the cutting member (e.g. a saw blade) can be inserted through the space defined between the first and second guide surfaces800A and800B to cut the respective bone. The guide surfaces800A and800B can serve to direct the cutting member to the location of the bone to be cut, which in many applications of thebone preparation instrument720 can be a precise location.
• When the bones have been cut on the one surgical patient, theguide members760 and/or770 can be removed and thebone preparation instrument720 can be discarded using conventional means. Removing theguide members760 and/or770 may include removing any bone preparation fixation pins from the bones as well as from theguide members760 and/or770. In some embodiments, the bones may then be compressed together and one or more bone plates may be applied.
• FIGS. 11A and 11B illustrate a third embodiment of abone preparation instrument830. Thebone preparation instrument830 can serve as a single bone preparation instrument included in embodiments thekit10 and be disposed after use on a single surgical patient.FIG. 11A shows a perspective view of thebone preparation instrument830, whileFIG. 11B shows a perspective cross-sectional view of thebone preparation instrument830. Thebone preparation instrument830 can be useful for temporarily fixing bones in a desired position during a surgical procedure, such as a bone alignment, osteotomy, and/or fusion procedure.
• Thebone preparation instrument830 can include a first bonepreparation fixation pin140A for attachment to afirst bone840. A second bonepreparation fixation pin140B can be provided for attachment to asecond bone850, such as an adjacent bone separated by a joint or different portions of a single bone. As shown best inFIG. 11B, afirst block855 having afirst aperture856 can slidably receive the first bonepreparation fixation pin140A, and asecond block860 having asecond aperture861 can slidably receive thesecond fixation pin140B. The first andsecond apertures856,861 can allow the first andsecond blocks855,860 to slide along a longitudinal axis of the first and second fixation pins140A,140B, respectively. The first andsecond apertures856,861 can also allow the first andsecond blocks855,860 to rotate about the longitudinal axis of the first and second fixation pins140A,140B, respectively. In some embodiments, the first and second fixation pins140A,140B are generally cylindrical and have a distal portion and a proximal portion, and the distal portion is threaded for retention within first and second bone, while the proximal portion is unthreaded for sliding within the first and second apertures and free rotational movement within the first and second apertures. In some embodiments, the proximal portion has a uniform diameter, such that it does not contain a flared or “head” portion. In such embodiments, the first and second blocks can be positioned on the first and second fixation pins before or after the pins are engaged with bone.
• Again as best shown inFIG. 11B, a multi-axis joint880 can be provided to connect thefirst block855 and thesecond block860 and located adjacent to a joint885 between the first and second bones. In some embodiments, the multi-axis joint880 allows thefirst block855 and thesecond block860 to move with respect to each other about more than one axis. In certain embodiments, the multi-axis joint880 allows thefirst block855 and thesecond block860 to move with respect to each other about the three cardinal planes (i.e., X, Y, and Z axes). In the embodiment shown, the multi-axis joint880 allows for angulation in all directions and rotation between the first and second blocks. In other examples, thebone positioning instrument830 can be attached to first andsecond bones840,850, where the first and second bones are skewed relative to each other. In this case, a longitudinal axis ofsecond bone850 is skewed, for example, about 15 degrees relative to a longitudinal axis offirst bone840.
• The multi-axis joint can include any suitable structure for allowing desired adjustments about more than one axis. In some embodiments, with reference toFIG. 11B, the multi-axis joint880 includes alink890 having afirst end894 rotatably connected to thefirst block855 and asecond end898 rotatably connected to thesecond block860. Such a multi-axis joint allows for the movement about the various axes discussed above at both the first end and the second end. In the embodiment shown, thefirst end894 includes a first ball received within a first socket of thefirst block855, and thesecond end898 includes a second ball received within a second socket of thesecond block860.
• Some embodiments of theinstrument830 allow the relative positions of the first and second bones to be fixed after a desired orientation has been achieved. For example, afirst set screw900 can extend through thefirst block855 into thefirst aperture856 and be positioned against thefirst fixation pin140A, for fixation of the first block on a longitudinal axis of the first fixation pin and/or about the longitudinal axis of the first fixation pin. Further, asecond set screw910 can extend through thesecond block860 into thesecond aperture861 and be positioned against thesecond fixation pin140B, for fixation of the second block on a longitudinal axis of the second fixation pin and/or about the longitudinal axis of the second fixation pin. In certain embodiments, the first and second set screws are positioned perpendicular to the first and second fixation pins. As shown inFIG. 11A,additional set screws920,930 extending through the first and second blocks can be positioned opposite of the first and second set screws, respectively. Such oppositely positioned set screws facilitate the use of the bone positioning device to be utilized, for example, on a left foot or a right foot.
• Set screws can also be provided to fix positions across the multi-axis joint. In the embodiment shown inFIG. 11B, a first end setscrew940 extends through thefirst block855 and is positioned against thefirst end894 of thelink890. Further, a second end setscrew950 is shown extending through thesecond block860 and positioned against thesecond end898 of thelink890.
• In some surgical procedures on a single surgical patient, theinstrument830 can be used to apply a compression force between two adjacent bones, or different portions of a single bone, while the bones are held in desired alignment and/or to facilitate a desired alignment between the bones. Such a compression force is useful for a surgical procedure such as bone fusion, for example. As shown inFIG. 11B, in some embodiments theinstrument830 includes acompression screw960 operable to exert a compression force between first andsecond bones840,850 connected to first and second fixation pins140A,140B, respectively. In the embodiment shown, thecompression screw960 is generally perpendicular to the fixation pins and is threadingly received within a block and positioned to act against one of the fixation pins.
• One of the blocks can be adapted to allow for relative movement to exert the compression force. In the embodiment shown inFIG. 11B, one of the blocks (e.g., the first block855) has afirst portion970 slidingly connected tosecond portion980. An aperture (e.g., the first aperture856) extends through the first portion and the second portion. In this embodiment, the first aperture has a first cross-sectional area in the first portion and a second cross-sectional area in the second portion, and the first cross-sectional area is smaller than the second cross-sectional area. Theset screw900 can extend through thefirst portion970. Thecompression screw960 can extend through thesecond portion980. Upon actuation, thecompression screw960 will act against thefixation pin140A and will pull thesecond portion980 of theblock855 away from thefixation pin140A. The force will be transmitted through the multi-axis joint880 through theother block860 andfixation pin140B, thereby applying a compression force that tends to press together leading surfaces of the first andsecond bones840,850.
• As will be appreciated, thebone preparation instrument830 can find particular use in positioning one or more bones on the single surgical patient. Once the one or more bones no longer need to be positioned using theinstrument830, theinstrument830 can be discarded using conventional means.
• Depending on the particular surgical procedure for which a specific embodiment of thekit10 is intended, one of the threebone preparation instruments520,720, or830 can be included in thekit10, and no other bone preparation instrument need be included.
• FIG. 12 illustrates a perspective view of bone preparation fixation pins140, shown and described as included in thekit10 with respect toFIG. 1. The bone preparation fixation pins140 can be used in conjunction with any one of thebone preparation instruments520,720, or830 to fixate the bone preparation instrument to one or more bones and provisionally position bones with respect to each other (e.g., rotationally, translationally, and/or elevationally) after removal of the bone preparation instrument and prior to installation of a bone plate. The bone preparation fixation pins140 can include afirst end990 and a second end995. The second end995 can be pointed and optionally threaded or fluted and inserted through an aperture of a bone preparation instrument and into a bone. Because the bone preparation fixation pins140 can be used across the various embodiments of the bone preparation instruments, efficiency is achieved when packingmultiple kits10 that each include a different single bone preparation instrument. Once the surgical procedure on the one surgical patient is finished, the at least one and no more than ten (e.g., 2, 4, 6, or 8) bone preparation fixation pins140 included in akit10 can be discarded using conventional means.
• Although not shown, some embodiments of thekit10 can include at least one and no more than two cutting instruments. For example, an embodiment of thekit10 can include at least one and no more than two saw blades. The saw blades can be used to cut one or more bones, such as in conjunction with a bone preparation instrument. Once the bone or bones are cut as desired for the specific surgical procedure on the single surgical patient, the at least one and no more than two saw blades can be discarded.
• Some embodiments of thekit10 may also include at least one and no more than four reamer sets (e.g., each having 1, 2, 3, or 4 reamers). The reamer can be used to prepare a surface of one or more bones and/or drill a hole in one or more bones. After appropriate surface preparation and/or hole creation has been completed as needed for the particular surgical procedure on the single surgical patient, the at least one and no more than four reamer sets can be discarded. Further examples of thekit10 that include at least one and no more than four reamer sets may also include a single reamer sizing template. In one instance, the single reamer sizing template can be integral to thecontainer20 such that when a reamer is to be removed from thekit10 during a surgical procedure the reamer can be placed on the reamer sizing template to determine a dimension (e.g. length, diameter) of the chosen reamer. In other instances, the reamer sizing template can be a separate component included in thekit10 that is removable from thecontainer20 so as to allow a dimension of the reamer to be determined external to thecontainer20. Once the specific surgical procedure has been completed on the single surgical patient, the reamer sizing template can be discarded.
• Although not shown, some embodiments of the kit can include one or more implants. For example, one or more implants useful for filling a bone void created during a surgical procedure, such as, for example, a metatarsal base wedge procedure or an Evens lengthening procedure, may be provided. Examples of such a one or more implant include an allograft bone wedge, a titanium bone wedge, a titanium wedge, a synthetic bone wedge, or any other bone substitute.
• In sum, various embodiments of the disposable single-use kit10 can include all or any combination of one or more of the described surgical items. The items to be included in thekit10 will vary depending on the specific surgical procedure for which thekit10 is intended to be used. Items included in thekit10 can be within the quantity ranges described herein, and the kit, including all of the surgical items included in thekit10, may be discarded after use on a single surgical patient. Some embodiments of the kit can include all components in a single sterile package. Other embodiments of the kit can include two or more sterile packages with different components in each sterile package. For example, a first sterile package containing the bone plates, fasteners, and pins may be provided along with a second sterile package containing instruments such as plate manipulation and/or bone preparation instruments. Such a kit can also be provided in modular form with components grouped together in separate sterile packages to be selected to provide a complete kit for the desired surgical procedure.
• Thus, embodiments of the invention are disclosed. Although the present invention has been described with reference to certain disclosed embodiments, the disclosed embodiments are presented for purposes of illustration, and not limitation, and other embodiments of the invention are possible. One skilled in the art will appreciate that various changes, adaptations, and modifications may be made without departing from the spirit of the invention.

Claims (17)

1. A disposable single-use surgical kit for a foot or ankle orthopedic procedure comprising:

a sterile container;

a plurality of unicortical bone plate fasteners included in the sterile container; and

at least one bone plate but no more than four bone plates included in the sterile container, each bone plate comprising:

a body having a top surface and a bone facing surface opposite the top surface; and

a first fixation hole extending through the body from the top surface to the bone facing surface and configured for receiving one of the plurality of unicortical bone plate fasteners included in the sterile container.

2. The kit ofclaim 1, wherein each bone plate is configured to be positioned across a tarsal-metatarsal joint for tarsal-metatarsal joint fusion.

3. The kit ofclaim 1, wherein the at least one bone plate but no more than four bone plates is two bone plates, a first one of the two bone plates being configured to span from a dorsal region of a medial cuneiform to a medial region of a first metatarsal and a second one of the two bone plates being configured to span from a plantar region of the first metatarsal to a medial region of the medial cuneiform.

4. The kit ofclaim 3, wherein:

each of the two bone plates has four fixation holes with two of the four fixation holes positioned on a distal region of the bone plate and two of the four fixation holes positioned on a proximal region of the bone plate; and

the plurality of unicortical bone plate fasteners is at least eight.

5. The kit ofclaim 1, wherein each of the plurality of unicortical bone plate fasteners is configured to be inserted through a fixation hole of a bone plate and through only one cortical wall of at least one of a first metatarsal and a medial cuneiform.

6. The kit ofclaim 1, wherein a number of the plurality of unicortical bone plate fasteners included in the sterile container is greater than or equal to a total number of fixation holes of the bone plates included in the sterile container.

7. The kit ofclaim 1, wherein a number of the plurality of unicortical bone plate fasteners included in the sterile container is equal to a total number of fixation holes of the bone plates included in the sterile container plus at least one and no more than four, and no other bone plate fasteners are included in the sterile container.

8. The kit ofclaim 1, wherein the body has a length defining a central longitudinal axis and a width defining an extent of the bone plate transverse to the central longitudinal axis, and wherein the width of the body is greater at a location along the central longitudinal axis having the first fixation hole compared to the width of the body at a location remote from the first fixation hole.

9. The kit ofclaim 1, wherein at least one bone plate further comprises an attachment member at least partially within the first fixation hole.

10. The kit ofclaim 1, wherein each one of the plurality of unicortical bone plate fasteners included in the sterile container comprises a head and a shaft, wherein the shaft of each one of the plurality of unicortical bone plate fasteners consists of one of one of two lengths, and there are no other lengths of bone plate fasteners within the sterile container.

11. The kit ofclaim 1, further comprising at least one and no more than three plate manipulation instruments included in the sterile container, wherein at least one of the plate manipulation instruments includes an end configured to drive one of the plurality of unicortical bone plate fasteners received within the first fixation hole into a bone.

12. The kit ofclaim 1, further comprising:

a bone preparation instrument included in the sterile container; and

at least one and no more than ten bone preparation fixation pins included in the sterile container.

13. A method for performing a surgical operation, the method comprising the steps of:

removing a plurality of bone plate fasteners from a sterile container, wherein each one of the plurality of bone plate fasteners comprises a head and a shaft, and wherein the shaft of each one of the plurality of bone plate fasteners consists of one of a first length, a second length, a third length, and a fourth length, and further wherein the diameter of each one of the plurality of bone plate fasteners consists of one of a first diameter, a second diameter, a third diameter, or a fourth diameter, and there are no other lengths or diameters of bone plate fasteners within the sterile container;

removing at least one and no more than four bone plates from the sterile container, the at least one and no more than four bone plates each comprising:

a body having a top surface and a bone facing surface opposite the top surface; and

a first fixation hole extending through the body from the top surface to the bone facing surface and configured for receiving one of the plurality of bone plate fasteners;

contacting a bone with the at least one and no more than four bone plates removed from the sterile container; and

inserting one of the plurality of bone plate fasteners removed from the sterile container through the first fixation hole and into the bone.

14. The method ofclaim 13,

wherein removing at least one and no more than four bone plates from the sterile container is removing two bone plates from the sterile container, and

contacting the bone comprises positioning each of the two bone plates across a tarsal-metatarsal joint.

15. The method ofclaim 14, wherein the plurality of bone plate fasteners comprise unicortical bone plate fasteners, and inserting one of the plurality of bone plate fasteners comprises inserting one of the plurality of unicortical bone plate fasteners.

16. The method ofclaim 13, further comprising:

removing at least one and no more than ten bone preparation fixation pins from the sterile container; and

fixing the single bone preparation instrument to the bone at a position near the bone location to be cut using the at least one and no more than ten bone preparation fixation pins.

17. The method ofclaim 13, further comprising:

removing at least one and no more than three plate manipulation instruments from the sterile kit;

inserting an end of one of the plate manipulation instruments into an attachment member configured at least partially within the first fixation hole of one of the bone plates removed from the sterile container; and

bending one of the bone plates while the end of the plate manipulation instrument is inserted in the attachment member.

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