CROSS-REFERENCE TO RELATED APPLICATIONSThis application is a continuation-in-part of U.S. patent application Ser. No. 15/592,912, filed on May 11, 2017, which is a non-provisional application that claims priority to U.S.Provisional Application 62/470,470, filed Mar. 13, 2017, the entireties of which are herein incorporated by reference.
FIELD OF THE INVENTIONThe present disclosure relates to surgical devices, and more particularly, stabilization systems including plates, for example, for trauma applications.
BACKGROUND OF THE INVENTIONBone fractures can be healed using plating systems. During treatment, one or more screws are placed on either side of a fracture, thereby causing compression and healing of the fracture. There is a need for improved plating systems as well as mechanisms for accurate use of the plating systems.
Additionally, modern improvements in the treatment of bone deformities and comminuted traumatic fractures called for the establishment of “normal” mechanical axes of the human skeleton. Multiple authors published results of their anatomic studies with a variety of nomenclatures. Eventually, nomenclature was standardized and nominal and extreme values for “normal” mechanical and anatomic axes were settled on. These established angles are used now by medical professionals, such as orthopedic surgeons, around the world as a reference for correcting deformity and restoring normal joint alignment post-trauma. While some existing software packages aid with this correction in the evaluation of x-rays, there are no currently available devices for use under fluoroscopy in the operating room.
SUMMARY OF THE INVENTIONIn accordance with the application, a system for treating a fracture in a bone is provided. In some embodiments, the system comprises: a bone plate configured to engage the bone, the bone plate comprising a proximal end, a distal end, a head portion, a neck portion and a shaft portion, wherein the head portion comprises a first row of holes and a second row of holes for receiving one or more fasteners therein, wherein the shaft portion comprises at least one additional hole for receiving a fastener therein; at least one fastener received in the head portion and positioned in the first row of holes or second row of holes; and at least one fastener received in the shaft portion and positioned in the at least one additional hole.
In other embodiments, the system comprises: a bone plate configured to engage the bone, the bone plate comprising a proximal end, a distal end, a head portion, a neck portion and a shaft portion, wherein the head portion comprises a first row of holes and a second row of holes for receiving one or more fasteners therein, wherein the shaft portion comprises at least one additional hole for receiving a fastener therein; at least one fastener received in the head portion and positioned in the first row of holes or second row of holes, wherein the at least one fastener is non-threaded; and at least one fastener received in the shaft portion and positioned in the at least one additional hole.
BRIEF DESCRIPTION OF THE DRAWINGSA more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, wherein:
FIG. 1 is a top perspective view of a bone plate in accordance with some embodiments.
FIG. 2A is a top view of a head of the bone plate ofFIG. 1.
FIG. 2B is a bottom view of a head of the bone plate ofFIG. 1.
FIG. 3 is a side perspective view of a head of the bone plate ofFIG. 1.
FIG. 4 is a view of the bone plate ofFIG. 1 attached to a bone.
FIG. 5 is an alternative view of the bone plate ofFIG. 1 attached to a bone.
FIG. 6 is a top view of a shaft of the bone plate ofFIG. 1 with a cross-sectional view shown beneath.
FIG. 7 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 8 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 9 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 10 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 11 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 12 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 13 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 14 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 15 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 16 is a top perspective view of an alternative bone plate in accordance with some embodiments.
FIG. 17 is a top perspective view of an aiming guide in accordance with some embodiments.
FIG. 18 is a side view of a mount of the aiming guide ofFIG. 17.
FIG. 19 is an alternative side view of a mount of the aiming guide ofFIG. 17.
FIG. 20 is a top perspective view of an aiming guide comprising a distal aiming guide and an optional proximal aiming guide in accordance with some embodiments.
FIG. 21 is a top perspective view of the aiming guide ofFIG. 20.
FIG. 22 is a bottom perspective view of an attachment post in accordance with some embodiments.
FIG. 23 is a top perspective view of the proximal aiming guide ofFIG. 20.
FIG. 24 is a top perspective view of the distal aiming guide with optional proximal aiming guide ofFIG. 20.
FIG. 25A is a view of the distal aiming guide with proximal aiming guide in a first setting.
FIG. 25B is a view of the distal aiming guide with proximal aiming guide in a second setting.
FIG. 25C is a view of the distal aiming guide with proximal aiming guide in a third setting.
FIG. 25D is a view of the distal aiming guide with proximal aiming guide in a fourth setting.
FIG. 26 is a cross-sectional view of a dial in the proximal aiming guide.
FIG. 27 is a top perspective view of dial in the proximal aiming guide.
FIG. 28 is a front view of a bone plate including rafting screws attached to a bone member.
FIG. 29 is a side view of the bone plate ofFIG. 28.
FIG. 30 is a top view of the bone plate ofFIG. 28.
FIG. 31 is a top perspective view of a rafting blade in accordance with some embodiments.
FIG. 32 is a top view of the rafting blade ofFIG. 31.
FIG. 33 is a side view of the rafting blade ofFIG. 31.
FIG. 34 is a side view of a pair of rafting blades attached to a plate in accordance with some embodiments.
FIG. 35A is a front view of the rafting blade ofFIG. 31.
FIG. 35B is a bottom perspective view of the rafting blade ofFIG. 31.
FIG. 36 is a top perspective view of an insertion guide for rafting blades in accordance with some embodiments.
FIGS. 37A and 37B are views of the insertion guide detached from the rafting blades ofFIG. 36.
FIGS. 38A and 38B are views of the rafting blades following insertion in accordance with some embodiments.
FIG. 39 is a top perspective view of rafting blades and an independent support screw in accordance with some embodiments.
FIG. 40A is a front view of a blocking mechanism for the rafting blades in accordance with some embodiments.
FIG. 40B is a front view of the blocking mechanism ofFIG. 40A rotated.
FIG. 41 is a side view of a rafting blade and locking cap in accordance with some embodiments.
FIG. 42 is a top perspective view of the rafting blade attached to the locking cap ofFIG. 41.
FIG. 43 is a top perspective view of the locking cap ofFIG. 41.
FIG. 44 is a top perspective view of a rafting blade having deforming ridges in accordance with some embodiments.
FIG. 45 is a bottom perspective view of the rafting blade having deforming ridges ofFIG. 44.
FIG. 46 is a diagram showing an alternate embodiment of an aiming guide according to one embodiment of the present invention.
FIG. 47 is a diagram showing a detailed view of the aiming guide according to one embodiment of the present invention.
FIGS. 48A-48C show one embodiment of the attachment post and threaded shaft in more detail.
FIGS. 49A-49B are diagrams showing exemplary tissue protection sleeves according to one embodiment of the present invention.
FIG. 50 is a diagram showing exemplary instruments passing through tissue protection sleeves that have been inserted into the guide holes of the aiming arm.
FIG. 51A is a top perspective view of the proximal aiming guide.
FIG. 51B is a diagram showing another top perspective view of the proximal aiming guide.
FIG. 52 shows one exemplary embodiment of a guide according to the present invention.
FIG. 53 is a diagram showing a more detailed view of a frontal plane (AP) guide mechanical and anatomic reference angles according to one embodiment of the present invention.
FIGS. 54-57 are diagrams showing examples of the guide being used to measure anatomic angles during interoperative use.
FIG. 58 is a diagram showing another embodiment of guide according to one aspect of the present invention.
FIGS. 59-60 are diagrams showing the guide ofFIG. 58 during intraoperative use.
FIG. 61 is a diagram showing a guide that includes dotted reference lines indicating the limits of each mechanical and anatomic axis.
FIG. 62A is a diagram showing an exemplary sagittal and frontal guide that are formed as a single, foldable element.
FIG. 62B is a diagram showing an exemplary frontal and sagittal guides that are positioned adjacent to one another.
FIG. 63 is a diagram showing an exemplary embodiment of a guide that includes one or more perforations.
DETAILED DESCRIPTION OF THE INVENTIONEmbodiments of the present application are generally directed to devices, systems and methods for bone stabilization. In particular, embodiments are directed to bone plates that extend across bone members to treat one or more fractures.
The plates described herein may be adapted to contact one or more of a femur, a distal tibia, a proximal tibia, a proximal humerus, a distal humerus, a clavicle, a fibula, an ulna, a radius, bones of the foot, bones of the hand, or other suitable bone or bones. The bone plates may be curved, contoured, straight, or flat. The plates may have a head portion that is contoured to match a particular bone surface, such as a metaphysis or diaphysis, flares out from the shaft portion, forms an L-shape, T-shape, Y-shape, etc., with the shaft portion, or that forms any other appropriate shape to fit the anatomy of the bone to be treated. The plates may be adapted to secure small or large bone fragments, single or multiple bone fragments, or otherwise secure one or more fractures. In particular, the systems may include a series of trauma plates and screws designed for the fixation of fractures and fragments in diaphyseal and metaphyseal bone. Different bone plates may be used to treat various types and locations of fractures.
The bone plates may be comprised of titanium, stainless steel, cobalt chrome, carbon composite, plastic or polymer—such as polyetheretherketone (PEEK), polyethylene, ultra high molecular weight polyethylene (UHMWPE), resorbable polylactic acid (PLA), polyglycolic acid (PGA), combinations or alloys of such materials or any other appropriate material that has sufficient strength to be secured to and hold bone, while also having sufficient biocompatibility to be implanted into a body. Similarly, the bone plates may receive one or more screws or fasteners that may be comprised of titanium, cobalt chrome, cobalt-chrome-molybdenum, stainless steel, tungsten carbide, combinations or alloys of such materials or other appropriate biocompatible materials. Although the above list of materials includes many typical materials out of which bone plates and fasteners are made, it should be understood that bone plates and fasteners comprised of any appropriate material are contemplated.
The bone plates described herein can be considered “locking” or “non-locking” plates. Locking plates include one or more openings for accepting one or more locking fasteners. The one or more openings can be partially or fully threaded. In some embodiments, these openings include fully threaded or stacked openings, which accept both locking and non-locking fasteners. In some embodiments, the locking fasteners include heads that are at least partially threaded. The locking fasteners can be monoaxial or polyaxial. One non-limiting example of a locking fastener (among others) is shown in FIG. 6 of U.S. application Ser. No. 15/405,368, filed Jan. 13, 2017, which is hereby incorporated by reference in its entirety.
Non-locking plates include one or more openings for accepting one or more non-locking fasteners. The one or more openings at least in part be non-threaded. In some embodiments, these openings include non-threaded or stacked openings, which accept both locking and non-locking fasteners. In some embodiments, the non-locking fasteners include heads that are non-threaded. The non-locking fasteners can be monoaxial or polyaxial. One non-limiting example of a non-locking fastener (among others) is shown in FIG. 4 of U.S. application Ser. No. 15/405,368, filed Jan. 13, 2017, which is hereby incorporated by reference in its entirety. In some embodiments, the non-locking fasteners can include dynamic compression screws, which enable dynamic compression of an underlying bone.
Below are various examples of locking and non-locking plates attachable to bone. In some embodiments, locking plates may be thicker than non-locking plates. Locking plates may be useful for patients that have weaker bone, while non-locking plates may be useful for patients that have strong bone.
The locking and non-locking plates described below can be attached to different bones to treat fractures. In particular, the locking and non-locking plates can be used to treat fractures of the tibia, though one skilled in the art will appreciate that the novel plates described herein can be applied to fractures on other types of bone as well. With respect to the tibia, the locking and non-locking plates can be considered to be lateral, medial or posteromedial plates. In other words, the plates can be attached to a lateral, medial or posteromedial aspect of a tibia. One skilled in the art will appreciate, however, that the plates are not limited to their specific locations on the tibia, and that a surgeon may choose to apply a lateral plate medially or a medial plate laterally, if desired. In the present application, the bone plates shown inFIGS. 1 and 7-10 can be viewed as lateral plates, while the bone plates shown inFIGS. 11-17 can be viewed as medial or posteromedial plates.
FIG. 1 is a top perspective view of a bone plate in accordance with some embodiments. In some embodiments, thebone plate10 comprises a lateral locking plate, wherein at least some of the fasteners received therein are locking fasteners. Thebone plate10 comprises aproximal end12 and adistal end14. Thebone plate10 further comprises ahead portion22, ashaft portion26, and atransitionary neck portion24 between thehead portion22 and theshaft portion26.
Thehead portion22 comprises a widest portion of thebone plate10 and is adjacent theproximal end12. In some embodiments, theproximal end12 is chamfered. Advantageously, theproximal end12 contour and chamfer helps to position thebone plate10 posterior to Gerdy's tubercle to minimize soft tissue irritation in a highly affected area. In some embodiments, thehead portion22 will be placed on a bone member (e.g., tibia) near an articular surface. Certain features of thehead portion22 are advantageously designed to prevent or resist subsidence of an articular surface. Thehead portion22 comprises a first row ofholes32 and a second row ofholes34. In some embodiments, theseholes32,34 are considered to be “rafting” holes that can receive rafting screws (e.g., as shown inFIG. 30) that advantageously support an articular surface of a joint and prevent subsidence. In some embodiments, theholes32,34 are locking holes that are at least partially threaded and designed to receive one or more polyaxial locking screws.
As shown inFIG. 1, thehead portion22 comprises a first row ofholes32 and a second row ofholes34, wherein the second row ofholes34 are larger than the first row ofholes32. For example, in some embodiments, the first row ofholes32 can be between 2.0 and 3.0 mm (e.g., 2.5 mm), while the second row ofholes34 can be between 3.0 and 4.0 mm (e.g., 3.5 mm). By providing two sets ofholes32,34, thebone plate10 advantageously accommodates a greater number of rafting screws, thereby providing greater support near a joint. In particular, the most proximal set ofholes32 are especially novel and advantageous, as they are designed to be adjacent theproximal end12 of thebone plate10. Theseholes32 receive rafting screws that are closest to an articular surface of a joint. Theseholes32 are advantageously smaller in size thanholes34, such that they can accommodate smaller rafting screws, which may be particularly hard to position in the limited space adjacent the articular surface. In some embodiments, the first row ofholes32 are offset from the second row ofholes34, while in other embodiments, the first row ofholes32 are aligned with the second row ofholes34. In some embodiments, the first row ofholes32 can have the same number of holes as the second row of holes, while in other embodiments, the first row ofholes32 can have a different number of holes as the second row of holes. In the present embodiment, thebone plate10 include fourholes32 and fourholes34.
As shown inFIG. 1, thehead portion22 further comprises one or more novelmulti-purpose holes36. In some embodiments, themulti-purpose holes36 are advantageously designed to accommodate a k-wire as well as a suture. In some embodiments, theholes36 are sized and positioned to receive a k-wire therein, thereby assisting in placement of thebone plate10 on a bone member. Theholes36 are formed adjacent and continuously with one or more undercuts37 (shown inFIGS. 2B and 3) of thebone plate10. As shown inFIG. 5, the one ormore undercuts37 advantageously allow access to one or more sutures through thebone plate10 even after thebone plate10 is implanted on bone. The sutures can be used to attach thebone plate10 to adjacent tissue, thereby further securing thebone plate10 at or near a surgical site.
Theneck portion24 is a transitionary portion between thehead portion22 and theshaft portion26. Theneck portion24 is less wide than thehead portion22, but has at least some portions that of equal or greater width than theshaft portion26. As shown inFIG. 1, theneck portion24 comprises a pair of lockingholes42, aninstrument attachment hole44,alignment indentations46, a positioning slot, and three kickstand holes52. Each of these features is described below.
The pair of lockingholes42 are positioned beneath the rafting holes32,34. In some embodiments, the locking holes42 comprise polyaxial locking holes that are at least partially threaded. The pair of lockingholes42 are configured to receive one or more bone fasteners or screws to secure thebone plate10 to an underlying bone member. In some embodiments, the pair of lockingholes42 are the same or similar width to theholes34. In some embodiments, each of the locking holes42 has a width between 3.0 and 4.0 mm (e.g., 3.5 mm).
Below the pair of lockingholes42 areindentations46 and aninstrument attachment hole44. Theindentations46 andinstrument attachment hole44 are designed to cooperate with an aiming guide, as shown inFIGS. 18 and 21. The aiming guide is particularly useful with lateral plates, and can be used to accurately guide one or more bone screws or fasteners into respective holes in abone plate10. In some embodiments, theindentations46 comprise spherical indentations. Unlike other holes or openings in thebone plate10, theindentations46 do not extend completely through a plate. Rather, theindentations46 are engaged by one or more ball-end pins (shown inFIG. 22) that extend outwardly from an attachment post of an aiming guide. Theindentations46 advantageously help to stabilize and position the aiming guide relative to thebone plate10. While thebone plate10 is shown as having threeindentations46, thebone plate10 can include one, two, or more than threeindentations46. Between theindentations46 is aninstrument attachment hole44. Theinstrument attachment hole44 comprises a threaded hole that is designed to receive a threaded shaft (shown inFIG. 22) that also extends outwardly from an attachment post of an aiming guide. Once the aiming guide is stabilized via theindentations46, the aiming guide can be attached to thebone plate10 via threading of the threaded shaft.
Apositioning slot48 is located distally and beneath theindentations46 andinstrument attachment hole44. Thepositioning slot48 comprises an elongated opening that is designed to receive a first bone screw or fastener therein before finalizing a position of abone plate10 on bone. As thepositioning slot48 is elongated, thebone plate10 can be slightly adjusted around a first bone fastener is needed. In some embodiments, thepositioning slot48 has a length that is greater than a length of any of the other holes that receive bone screws therein. In some embodiments, thepositioning slot48 has a length that is at least twice the length of a length of any of the other holes that receive bone screws therein. The first bone fastener can be provisionally placed in thepositioning slot48 prior to final tightening of the first bone screw. Upon proper orientation and placement of thebone plate10, the first bone fastener can be finally tightened.
One or more kickstand holes62 are provided distally from thepositioning slot48. In some instances, lateral plates may be preferred over medial plates, as they can often be implanted via a smaller incision with less risk to surrounding tissue. The one or more kickstand holes62 are capable of receiving one or more bone fasteners that can treat medial fractures if desired. In other words, the kickstand holes62 advantageously allow a medial fracture to be treated via support from just the lateral side. As shown inFIG. 1, thebone plate10 includes at least three kickstand holes62. In some embodiments, the kickstand holes62 are fixed angle, stacked locking holes. By providing a triple kickstand construct with threekickstand holes62, this advantageously accommodates up to three bone fasteners to better support a medial fracture. In some embodiments, the triple kickstand construct serves as a novel collection of kickstand holes62 aimed at the anterior, middle, and posterior aspects of the medial proximal tibia, thereby providing the surgeon with options and enhanced versatility. The triple kickstand construct advantageously provides a surgeon with options for which fragments to target and allows the surgeon to customize construct rigidity with one or more screws or fasteners. In other embodiments, the kickstand construct will have a single kickstand hole, two kickstand holes, or more than three kickstand holes.
Theshaft portion26 comprises a distal portion of thebone plate10 relative to thehead portion22 andneck portion24. In some embodiments, theshaft portion26 comprises a longest and narrowest portion of thebone plate10. Theshaft portion26 comprises a number of openings or holes therein for receiving one or more bone fasteners. In the present embodiment, theshaft portion26 comprises a plurality of holes62 (e.g., five) that serve as fixed angled, stacked locking holes. These fixed angle, stacked locking holes allow mono-axial insertion of bone fasteners that can be locking or non-locking. In addition, as shown inFIG. 1, theshaft portion26 of thebone plate10 also comprises a bi-direction,dynamic compression slot64 that is positioned in between the locking holes62. The bi-directionaldynamic compression slot64 advantageously allows for static insertion of non-locking screws into the shaft of bone. They also allow for compression (e.g., 0.5 mm-2 mm) along the shaft of the bone through eccentric insertion of a non-locking screw. Theholes62 andslot64 are capable of receiving one or more screws therein to secure thebone plate10 to bone.
The distal portion of theshaft portion26 further comprises a taperedtip18. In some embodiments, the taperedtip18 serves as an insertion tip that allows theplate10 to be inserted beneath skin to a surgical site. Thebone plate10 can be positioned adjacent to bone (e.g., a tibia), whereby it can be fixed to the bone. In some embodiments, the tapered tip allows for simplified submuscular plate insertion to minimize incision length. As shown inFIG. 1, an underside of theshaft portion26 of thebone plate10 comprises a plurality ofscallops66. Thescallops66 form a scalloped contact surface which provides better frictional contact with a bone member. In some embodiments, the scalloped contact surface minimizes impact to the periosteal blood supply and allows some bending of theshaft portion26 of thebone plate10 without deforming threaded holes.
In some embodiments, thebone plate10 provides an anatomic contour that accommodates a lateral aspect of the proximal tibia. In some embodiments, thebone plate10 includes a proximal anterior portion (e.g., chamfered portion) that sits just posterior to Gerdy's tubercle, thereby assisting with positioning while minimizing soft tissue irritation.
FIG. 2A is a top view of a head of the bone plate ofFIG. 1. Thehead portion22 comprises a widest most portion of thebone plate10. As shown inFIG. 2A, thehead portion22 accommodates a first row ofholes32a,32b,32c,32dand a second row ofholes34a,34b,34c,34d.As noted above, the first row holes of holes and second row of holes can serve as “rafting” holes to accommodate rafting screws therein. In some embodiments, the first row ofholes32 are smaller than the second row ofholes34. In addition, in some embodiments, the first row ofholes32 are offset from the second row ofholes34. As shown inFIG. 2A, a pair of novelmulti-purpose holes36a,36bare also provided through thehead portion22 of thebone plate10. Themulti-purpose holes36a,36bare each configured to receive a k-wire and/or suture therethrough. Also shown inFIG. 2A are features of theneck portion24, including the locking holes42a,42b,theindentations46a,46b,46cand theinstrument attachment hole44.
FIG. 2B is a bottom view of a head of the bone plate ofFIG. 1. From the bottom view, one can see the underside of thehead portion22 of thebone plate10. In particular, one can see the underside of themulti-purpose holes36a,36band how they are formed adjacent and continuously withundercuts37a,37bformed on thebone plate10. As shown inFIG. 5, theundercuts37a,37badvantageously allow a suture to be threaded between abone plate10 and anunderlying bone2, even when thebone plate10 is positioned adjacent thebone2. As shown inFIG. 2B, theundercuts37a,37bsurround the perimeters of each of themulti-purpose holes36a,36b.
FIG. 3 is a side perspective view of a head of the bone plate ofFIG. 1. From this view, one can see the curved angle of thehead portion22 of thebone plate10. In addition, one can see how theundercuts37a,37bfollow the curved contour of thebone plate10 and are curved themselves.
FIG. 4 is a view of the bone plate ofFIG. 1 attached to a bone. Thebone plate10 includes a plurality of screws orfasteners6 received therein.Screws6 that are received in theholes32a,32b,32c,32d,as well as in theholes34a,34b,34c,34d,can be considered rafting screws. As shown inFIG. 4, the rafting screws are positioned close to an articular surface4 of the bone2 (e.g., tibia) and advantageously help to provide support for the articular surface4. In other words, the rafting screws help to serve as rebar for the articular surface4. From this view, one can also see a suture undercut37athat is formed at a corner of thebone plate10.
FIG. 5 is an alternative view of the bone plate ofFIG. 1 attached to a bone. From this view, one can see how the undercut37 forms an opening between thebone plate10 andbone2 such that there is access to thread a suture even when thebone plate10 is implanted onbone2.
FIG. 6 is a top view of a shaft of the bone plate ofFIG. 1 with a cross-sectional view shown beneath. Theshaft portion26 includes a number of holes or openings for receiving different bone screws (e.g., locking or non-locking) therein. In some embodiments, theshaft portion26 can vary in length to accommodate different bones in different sized patients. As shown inFIG. 6, each of the vertical perforated lines represents a possible cutoff or end of abone plate10. For patients with smaller bones, the cut-off could be sooner, while for patients with larger bones, the cut-off could be later. In some embodiments, theshaft portion26 accommodates a unique hole or opening pattern whereby the hole immediate preceding a plate end will be a fixed angle,stacked hole62. By providing astacked hole62 that precedes a plate end, thebone plate10 can accommodate either a locking or a non-locking screw, thereby providing a large number of options for a surgeon implanting the plate. In some embodiments, the novel pattern of holes or openings in theshaft portion26 includes holes that are spaced apart (e.g., 12-14 mm) center-to-center and allows plate lengths to be offered in two-hole increments while maintaining that the last hole will always be a stacked hole. In some embodiments,bi-directional compression slots64 can be worked into the hole pattern, but can appear less than the stackedholes62 as they may be used less frequently. The unique hole pattern maximizes equidistant locking and non-locking options in theshaft portion26 while still providing dynamic compression capabilities. In addition, the last hole before the plate end allowing a statically placed locking or non-locking screw is preserved in all two-hole plate increments, as shown inFIG. 6.
FIG. 7 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate10 comprises a lateral non-locking plate wherein at least some of holes or openings therein receive non-locking fasteners. Thebone plate10 includes similar features to the bone plate inFIG. 1, including aproximal end12 and adistal end14, ahead portion22, aneck portion24 and ashaft portion26. Thehead portion22 accommodates different sized rafting screws via a first row of rafting holes32 and a second row of rafting holes34. Thehead portion22 also includesmulti-purpose holes34 capable of receiving a k-wire and/or suture therein. However, thebone plate10 can include additional non-locking holes for receiving non-locking fasteners, as will be discussed in greater detail herein.
In some embodiments, theneck portion24 can compriseholes42 beneath the rafting holes. Theholes42 comprise a trio of non-locking holes capable of receiving non-locking fasteners therein. Beneath theholes42 comprises anelongated positioning slot48 for receiving a first bone screw, as discussed above.
In some embodiments, theshaft portion26 comprises a number of non-locking holes.Shaft portion26 comprises anon-locking hole62 for receiving a non-locking fastener. In addition,shaft portion26 comprises a series of bi-directional dynamic compression slots64 (which can also be viewed as non-locking openings) for receiving one or more bone fasteners therein. Thedistal end14 of thebone plate10 comprises a taperedtip18 that aids in insertion of thebone plate10. An underside of theshaft portion26 comprises a plurality ofscallops66.
FIG. 8 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate10 comprises alateral plate10 having one or more locking holes for receiving locking fasteners. In some embodiments, the thickness of thelateral bone plate10 varies from 2.2 mm proximally to 3.4 mm distally, with the thickness transition occurring in the neck of thebone plate10. Thebone plate10 includes many features as the bone plate inFIG. 1, including aproximal end12, adistal end14, ahead portion22, aneck portion24, and ashaft portion26. Thehead portion22 is the widest portion of thebone plate10 and includes a pair of rows of rafting holes32,34, as well as a pair ofmulti-functional holes36 for receiving a k-wire and/or suture therein. Theneck portion24 is also similar to that of the bone plate inFIG. 1, as it includes a pair of polyaxial locking holes42, a trio ofspherical alignment indentations46, a threadedinstrument attachment hole44, apositioning slot48 and a trio of kickstand holes52. However, theshaft portion26 of thebone plate10 ofFIG. 8 comprises a different pattern of holes as will be discussed herein.
As shown inFIG. 8, theshaft portion26 comprises a plurality ofholes62,64. Theholes62 comprise fixed angle locking holes (e.g., 3.5 mm), while theadjacent holes64 comprise dynamic compression slots. Theshaft portion26 comprises several pairs of fixedangle locking holes62 adjacent thedynamic compression slots64, which can be viewed as non-locking.
FIG. 9 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate10 comprises alateral plate10 having one or more locking holes for receiving locking fasteners. Thebone plate10 includes many features as the bone plate inFIG. 1, including aproximal end12, adistal end14, ahead portion22, aneck portion24, and ashaft portion26. Thehead portion22 is the widest portion of thebone plate10 and includes a pair of rows of rafting holes32,34. In contrast to the bone plate inFIG. 1, thehead portion22 includes a k-wire recess therein22 that is separate from a pair of suture holes74.
Theneck portion24 is also similar to that of the bone plate inFIG. 1, as it includes a pair of polyaxial locking holes42, a trio ofspherical alignment indentations46, a threadedinstrument attachment hole44, apositioning slot48 and a trio of kickstand holes52. However, theshaft portion26 of thebone plate10 ofFIG. 9 comprises a different pattern of holes as will be discussed herein.
As shown inFIG. 9, theshaft portion26 comprises a plurality of fixed angle, locking holes62. Unlike the prior embodiments, there is no compression slot or hole positioned adjacent the locking holes62. In some embodiments, the fixed angle, locking holes are spaced evenly, while in other embodiments, the fixed angle, locking holes are not spaced evenly. In addition to these lockingholes62, theshaft portion26 further comprises a taperedtip18 and a scalloped contact surface.
FIG. 10 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate110 comprises a medial plate which can be placed on a bone (e.g., tibia) via a medial approach. In some embodiments, the thickness of themedial bone plate110 varies from 2.2 mm proximally to 3.4 mm distally, with the thickness transition occurring in the neck of thebone plate110. Thebone plate110 comprises aproximal end112 and adistal end114. Ahead portion122,neck portion124 andshaft portion126 extend between theproximal end112 anddistal end114.
Thehead portion122 comprises a widest most portion of thebone plate110, and includes a series ofholes134 for receiving fasteners therein. In the present embodiment, theholes134 comprise polyaxial locking holes configured to receive one or more locking fasteners therein. In the present embodiment, thehead portion122 comprises four lockingholes134. In other embodiments, thehead portion122 can comprise one, two, three or more than four lockingholes134. In some embodiments, the holes are between 2.5 mm and 4.5 mm, such as approximately 3.5 mm. Thehead portion122 further comprises one or more k-wire openings136. The k-wire openings136 (of which three are shown) are positioned near theproximal end112 of theplate110 and are configured to receive one or more k-wires therethrough. In some embodiments, thehead portion122 can be sized and configured to extend to an anterior portion of a bone (e.g, a tibia).
Theneck portion124 comprises a pair ofholes142 for receiving one or more fasteners therein. In some embodiments, theholes142 comprise polyaxial locking holes that are between 2.5 mm and 4.5 mm (e.g., 3.5 mm). In some embodiments, the locking holes are threaded so as to receive one or more threaded locking fasteners. Apositioning slot148 is positioned between the locking holes142. Thepositioning slot148 is an elongated slot (e.g., greater than two times the length of the adjacent holes142) that is configured to receive a first screw therein.
Theshaft portion126 comprises a plurality ofholes162, as well as acompression slot164. In some embodiments, the plurality ofholes162 comprise fixed angle, stacked locking holes that are between 2.5 mm and 4.5 mm, such as 3.5 mm. In some embodiments, the compression slot1645 comprises a bi-directional dynamic compression slot. Theshaft portion126 further comprises a taperedtip118 that assists thebone plate110 during insertion. In addition, theshaft portion126 comprises an underside having one ormore scallops166 forming a scalloped contacting surface.
FIG. 11 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate110 comprises a medial plate. Thebone plate110 is similar to the bone plate inFIG. 10, and includes aproximal end112, adistal end114, ahead portion122, aneck portion124 and ashaft portion126. However, the shape and size of thehead portion122 is distinguishable. In contrast to the head portion of the bone plate inFIG. 10, which is substantially symmetrical along a longitudinal axis of the bone plate, inFIG. 11, thehead portion122 is offset from a longitudinal axis of the bone plate. In some embodiments, the offset head allows thebone plate110 to reach a posterior portion of a bone member (e.g., tibia).
FIG. 12 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate110 comprises a posteromedial plate that can be inserted through an incision over a posteromedial aspect of a bone (e.g,. tibia). Thebone plate110 includes a number of similar features as the medial plates inFIGS. 10 and 11, including aproximal end112, adistal end114, ahead portion122, aneck portion124, and ashaft portion126. However, in the present embodiment, thebone plate110 includes severalnon-locking holes134 in thehead portion122, as well as several stacked locking holes162 in theshaft portion126.
In particular, as shown inFIG. 12, thehead portion122 comprises a row of non-locking holes134 (e.g., between 2.5 mm and 4.5 mm) that are positioned below a row of k-wire holes. In addition, thehead portion122 comprises a singlenon-locking hole142 positioned below the row ofnon-locking holes134. Theshaft portion126 comprises a series of fixed angle, stacked locking holes162 (e.g., between 2.5 mm and 4.5 mm) including a bi-directionaldynamic compression slot164 therebetween.
FIG. 13 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate110 comprises a medial plate that is inserted through an incision over a medial aspect of a bone (e.g., tibia). Thebone plate110 is similar to the bone plate inFIG. 11, but includes a different hole pattern along theshaft portion126. In the present embodiment, theshaft portion126 comprises several pairs of holes—a fixed angled locking hole162 (between 2.5 mm and 4.5 mm) adjacent adynamic compression slot164.
FIG. 14 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate110 comprises a medial plate that is inserted through an incision over a medial aspect of a bone (e.g., tibia). Thebone plate110 is similar to the bone plate inFIG. 13, except thehead portion122 of thebone plate110 includes a plurality ofnon-locking holes134,142 (between 2.5 mm and 4.5 mm) rather than locking holes.
FIG. 15 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate110 comprises a medial plate that is inserted through an incision over a medial aspect of a bone (e.g., tibia). Thebone plate110 includes aproximal end112, adistal end114, ahead portion122, aneck portion124 and ashaft portion126. The head portion comprises a row of polyaxial locking holes134 (between 2.5 mm and 4.5 mm). The locking holes134 are formed distally beneath suture holes174. The suture holes174 are independent from arecess172 for a k-wire. Thehead portion122 also includes a fixed angle locking hole142 (between 2.5 mm and 4.5 mm). Theneck portion124 comprises apositioning slot148 and an additional fixedangle locking hole142. Theshaft portion126 comprises a plurality of alternating locked or unlockedholes162 andcompression slots164.
FIG. 16 is a top perspective view of an alternative bone plate in accordance with some embodiments. In some embodiments, thebone plate110 comprises a posteromedial plate that is inserted through an incision over a posteromedial aspect of a bone (e.g., tibia). Thebone plate110 includes similar features as prior embodiments, including ahead portion122 having polyaxial locking holes134 (between 2.5 mm-4.5 mm), suture holes174 and a k-wire recess172. Theneck portion124 includes a pair of fixed angle locking holes142 (between 2.5 mm and 4.5 mm) and apositioning slot148 therebetween. Theshaft portion126 comprises a series of in-line openings orholes162 that can accommodate a locking or non-locking fastener therein.
In some embodiments, an aiming guide can be provided to assist a surgeon in placing one or more screws or fasteners into a patient. The aiming guide can be mounted to a bone plate, and can include guide holes that align with holes in the bone plate such that screws or fasteners can be accurately implanted into a patient. In some embodiments, the guide holes can accept aiming sleeves that interface with drill guides, trocars, k-wires and screws. These sleeves can be secured to the aiming guide by a ratcheting or clipping mechanism. While the aiming guide can be particularly useful for lateral plates, the aiming guide can also be used for medial and posteromedial plates.
FIG. 17 is a top perspective view of an aiming guide in accordance with some embodiments. The aimingguide200 can be mounted to anunderlying plate10, and includes an aimingarm210 and an aimingmount230.
The aimingarm210 comprises a plurality of guide holes262a,262b,262c,262dthat correspond withholes62a,62b,62c,62dof theplate10. The purpose of the guide holes262 is to help guide one or more fasteners or screws into the correspondingholes62 with precision and accuracy. In some embodiments, the guide holes262 can receive aiming sleeves that interface with drill guides, trocars, k-wires or screws. The aimingarm210 includes anopening264 on one end for receiving anarm fixation bolt236 therein and an opening266 on the opposing end for receiving adistal locking bolt238 therein. Thearm fixation bolt236 is configured to extend and secure the aimingarm210 to the aimingmount230. Thedistal locking bolt238 is configured to engage an opening near a distal end of abone plate10, thereby providing a stable construct. In some embodiments, the aimingarm210 is formed of a non-metal, such as a carbon fiber. By forming the aimingarm210 of a non-metal, this advantageously prevents it from being visible on an x-ray.
The aimingmount230, which is attached to the aimingarm210, serves as a mount on theplate10. The aiming mount230 (shown inFIGS. 18 and 19) comprises an upright post portion including a pair ofopenings244 for receiving ananti-rotation bolt234 therein and anopening244 for receiving afixation bolt232 therein. Thefixation bolt232 serves to attach the aiming mount230 (and thus the entire aiming guide200) to aplate10. Thefixation bolt232 can be received in an attachment hole44 (shown inFIG. 1) of theplate10. Theanti-rotation bolt234 can be inserted into either of the mono-axial openings244 to provide additional rigidity during insertion. In some embodiments, the aimingmount230 can be a different material from aimingarm210, as the aimingmount230 does not obstruct viewing of theholes62 in theplate10. In some embodiments, the aimingmount230 can be formed of metal while the aimingarm210 can be formed of non-metal. The means of connecting the aimingarm210 to the aimingmount230 will not be described in more detail.
FIG. 18 is a side view of a mount of the aiming guide ofFIG. 17. The aimingmount230 comprises an upright post having an upper section and a lower section. The upper section comprises a plurality of openings235 (shown inFIG. 19) for receiving stabilizingpins240 therein. The aimingarm210 attaches to the aimingmount230 by sliding over the stabilizingpins240 and tightening thearm fixation bolt236. Thearm fixation bolt236 is received in a threaded mounting hole237 (shown inFIG. 19) that is formed on the upper section of the aimingmount230.
The aimingmount230 further comprises a lowersection including openings244 for receiving one or more anti-rotation bolts234 (shown inFIG. 17). The one or moreanti-rotation bolts234 provide additional rigidity to the aimingmount230. The lower section includes anotheropening231 through which the fixation bolt232 (shown inFIG. 17) extends therethrough. The lower section can further include apositioning feature239 that guides and orients the aimingmount230 into a proper position relative to theunderlying bone plate10.
FIG. 19 is an alternative side view of a mount of the aiming guide ofFIG. 17. From this view, one can see specific features of the upper section and lower section of the aimingmount230. In particular, in the upper section, one can see the plurality ofopenings235 for receiving stabilizingpins240 therein. In addition, one can see the threaded mountinghole237 that receives thearm fixation bolt236 to secure the aimingarm210 to the aimingmount230. Between the upper section and the lower section of the aimingmount230 is anopening231 for receiving thefixation bolt232 therein. From this view, one can see theopenings244 in the lower section for receiving one or moreanti-rotation bolts234 therein.
FIG. 20 is a top perspective view of an aiming guide comprising a distal aiming guide and an optional proximal aiming guide in accordance with some embodiments. The distal aimingguide210 is capable of guiding one or more fasteners or screws into distal openings or holes (such as holes orslots62,64) of thebone plate10, while the proximal aimingguide310 is capable of guiding one or more fasteners or screws into proximal openings or holes (such as rafting holes32,34) of thebone plate10. In some embodiments, both the distal and proximal aiming guides210,310 are capable of accepting one or more aiming sleeves that interface with drill guides, trocars, k-wires, and screws. These sleeves can be secured to the respective guide by a ratcheting or clipping mechanism.
The distal aimingguide210 comprises an arm including a plurality of guide holes262 formed therein. The plurality of guide holes262 are sized and configured to receive one or more aimingsleeves270 that interface with drill guides, trocars, k-wires and screws. In some embodiments, the one or more aimingsleeves270 help guide screws into holes orslots62,64. The arm includes anextension portion263 that includes one or more additional guide holes265 for receiving one or more aimingsleeves270 therein. The one ormore sleeves270 received in the one or more guide holes265 can be used to direct screws or fasteners into one or kickstand holes of thebone plate10. The distal aimingguide210 further comprises at least one opening for receiving anattachment post280 therethrough. Theattachment post280 is configured to attach to thebone plate10.
The proximal aimingguide310 comprises one or more guide holes362 that can be used to direct screws or fasteners into the rafting holes32,34 of thebone plate10. In the proximal aimingguide310, each of the guide holes362 is formed of a pair of overlapping openings or circles. For example, as shown inFIG. 23,guide hole362ais formed of a pair of overlapping openings or circles, as areguide holes362b,362c,362d.By providing a pair of overlapping openings or circles, each of the guides holes362a,362b,362c,362dcan effectively guide one or more fasteners or screws into a rafting hole in a first row or a second row, based on surgeon preference. For example, as shown inFIGS. 25A-25D, guidehole362awill guide a screw intorafting hole32a,guide hole362bwill guide a screw intorafting hole32b,guide hole362cwill guide a screw intorafting hole32c,and guidehole362dwill guide a screw intorafting hole32d.In some embodiments, thedial360 of the proximal aimingguide310 can assume four different positions at 20 degrees apart for targeting holes in theunderlying plate10 that are coaxial with theholes362 in the guide. In some embodiments, the proximal aimingguide310 can rotate out of the way to allow for easier visualization of theplate10.
In some embodiments, the proximal aimingguide310 comprises adial360 that indicates which of the guide holes362a,362b,362c,362dwill be available for use. In some embodiments, only asingle guide hole362a,362b,362c,362dwill be available in each setting, thereby reducing the risk of confusion to a surgeon. The dial is rotatable and has a setting that corresponds with each of the guide holes362,362b,362c,362d.
FIG. 21 is a top perspective view of the distal aiming guide ofFIG. 20. As shown in the figure, the distal aimingguide210 comprises an arm having a plurality of guide holes262 extending along a length of the arm. The guide holes262 correspond to one or more holes or slots in thebone plate10, thereby allowing a screw to be easily guided into a proper position on the plate. In some embodiments, the guide holes262 are coaxial with holes or slots in thebone plate10. In some embodiments, the guide holes262 accept a guide (e.g., a sleeve) in different positions to target non-locking plate holes in either a static or eccentric position. This facilitates percutaneous insertion of non-locking screws either statically or for dynamic compression. In some embodiments, the distal aimingguide210 includes guide holes262 that correspond with holes or slots in theshaft portion26 of thebone plate10, as well as guide holes265 that correspond with kickstand holes in theneck portion24. In some embodiments, the guide holes262 that correspond with holes or slots in theshaft portion26 accepts only one type of aimingsleeve270, while the guides holes265 that correspond with the kickstand holes in theneck portion26 accept another type of aimingsleeve270. In some embodiments, the distal aimingguide210 can be formed of a radiolucent material to prevent obstruction of fluoroscopic imaging while in an operating room.
The distal aimingguide210 includes a pair ofattachment arms267,269. Thefirst attachment arm267 comprises afirst connection281aand thesecond connection arm269 comprises asecond connection281b.Each of theseconnections281a,281bis capable of attachment to an optionalproximal aiming guide310. By providing twoconnections281a,281b,the distal aimingguide210 is advantageously reversible such that it is can be acceptably used via left hand or right hand.
FIG. 22 is a bottom perspective view of an attachment post in accordance with some embodiments. Theattachment post280 is insertable through aconnection opening381 in the proximal aiming guide310 (shown inFIG. 20), as well as through a connection281 (shown inFIG. 21) in the distal aiming guide210 (shown inFIG. 21). Theattachment post280 is configured to engage anunderlying bone plate10. Theattachment post280 comprises one or more ball-end pins282 for engaging alignment indentations44 (shown inFIG. 1) of thebone plate10. In addition, theattachment post280 comprises a threadedshaft284 for threadingly attaching to aninstrument attachment hole44 in thebone plate10. Theattachment post280 further comprises a stabilizingfeature287 that assists with alignment during attachment.
FIG. 23 is a top perspective view of the proximal aiming guide ofFIG. 20. From this view, one can see the guide holes362a,362b,362c,362d,as well as thedial360 that determines which of the guide holes362a,362b,362c,362dis available for use. In addition,FIG. 23 shows neighboring guide holes392 through which one or more additional aiming sleeves can be inserted. In addition, aconnection opening381 is shown through which anattachment post280 can be received therein. In some embodiments, theconnection opening381 in the proximal aimingguide310 is coaxial with aconnection281 in the distal aimingguide210, such that theattachment post280 can extend through both the proximal aimingguide310 and the distal aimingguide210.
FIG. 24 is a top perspective view of the distal aiming guide with proximal aiming guide ofFIG. 20. From this view, one can see how theattachment post280 extends through theconnection opening381 of the proximal aimingguide310 and into theconnection281 in the distal aimingguide210 before engaging thebone plate10. Theattachment post280 advantageously serves as a means to secure the distal aimingguide210 with the proximal aimingguide310.
FIG. 25A is a view of the distal aiming guide with proximal aiming guide in a first setting. In this first setting of thedial360, the aimingsleeve270 is capable of being inserted intoguide hole362a.
FIG. 25B is a view of the distal aiming guide with proximal aiming guide in a second setting. In this second setting of thedial360, the aimingsleeve270 is capable of being inserted intoguide hole362b.
FIG. 25C is a view of the distal aiming guide with proximal aiming guide in a third setting. In this third setting of thedial360, the aimingsleeve270 is capable of being inserted intoguide hole362c.
FIG. 25D is a view of the distal aiming guide with proximal aiming guide in a fourth setting. In this fourth setting of thedial360, the aimingsleeve270 is capable of being inserted intoguide hole362d.
FIG. 26 is a cross-sectional view of a dial in the proximal aiming guide.FIG. 27 is a top perspective view of dial in the proximal aiming guide. Thedial360 comprises a rotating mechanism that uses a variation of aHirth coupling382 and aspring384 that accommodates different settings. As thedial360 is rotated by hand, thetop coupling382aof theHirth coupling382 exerts a force on thebottom coupling382bcausing it to translate axially along a shaft. Once clearance is achieved, thedial360 will complete its designed rotation (e.g., 20 degrees) with a click. Theretention cap387 holds thedial360 in place axially along the shaft and counteracts the force of thespring384 which forces thebottom coupling382bto translate down with the rotation.
As noted above, embodiments of the bone plates can include one or more rows of rafting openings or holes for receiving rafting screws therein. These rafting screws can be provided at or near an articular joint of a bone, thereby reducing the risk of subsidence at the articular joint. More details regarding the rafting screws, as well the optional use of non-threaded rafting blades, are provided below.
FIG. 46 is a diagram showing an alternate embodiment of an aiming guide according to one embodiment of the present invention. In the illustrated embodiment, the aiming guide452 may be operatively connected to anunderlying plate10, and includes an attachment post454 and a threaded shaft456. The aiming guide452 illustrated inFIG. 46 and its individual components are similar to the aimingguide200 described with respect toFIGS. 17-22 above, with some modifications. The modifications to the aimingguide200 will be described in turn below.
FIG. 47 is a diagram showing a detailed view of the aiming guide452 according to one embodiment of the present invention. The embodiment of the aiming guide452 shown inFIG. 47 may provide one advantage of allowing a single rigid connection between the aiming guide452 and thebone plate10, as described in more detail below. When the rigid connection is in place, the correspondingholes262 of the aiming arm458 and theholes62 of thebone plate10 are coaxial. In the illustrated embodiment, the aiming guide452 includes an aiming arm458 and an attachment guide460. The aiming arm458 is substantially similar to the aimingarm210 described with respect toFIG. 17, and includes one or more guide holes262 that help guide one or more fasteners, screws, or other instruments into the correspondingholes62 of theplate10 with accuracy. In contrast to theFIG. 17 embodiment, the aiming guide452 of theFIG. 46-47 embodiment, does not include an aimingmount230. Instead, the aiming guide452 includes an attachment guide460 that is configured and dimensioned to extend from a portion of the aiming arm458.
In one embodiment, the attachment guide460 may extend from one side459 of the aiming arm458, as shown inFIG. 47. The attachment guide460 may be positioned such that it is near one end, e.g., the distal461 or proximal end463, of the aiming arm458. In some embodiments, it may be desirable for the attachment guide460 to comprise an arm that extends from the aiming arm458, as shown inFIG. 47. At least a portion of the attachment guide460 may be configured and dimensioned to be angled such that it can guide the attachment post454 into theinstrument attachment hole44 in thebone plate10. Alternately, the attachment hole462 itself, through which the attachment post454 passes, may be configured and dimensioned to include an angle that allows the attachment post454 to be guided into theinstrument attachment hole44. In such an embodiment, the attachment guide460 may be angled and may lie in the same plane as the aiming arm458. In other embodiments, both the attachment guide460 and the attachment hole462 may be configured and dimensioned to include angles. Alternately, the attachment guide460 may be configured and dimensioned such that the attachment hole462 is coaxial with a hole in the neck portion of thebone plate10, such as theinstrument attachment hole44.
The aiming guide452, according to one embodiment, may include “left” or “right” configurations to assist with guiding the insertion of screws or other instruments throughplates10 of various configurations. In a left configuration, shown inFIG. 47, the attachment guide460 is configured and dimensioned as an arm that extends from one side459 of the aiming arm458. Although a left configuration is shown inFIGS. 46-47, a right configuration may comprise an attachment guide460 that extends from the opposite side465 of the aiming arm458. In some embodiments, both a “left” and a “right” configuration may be included if desired, i.e., both a left and right arm may be attached to the aiming arm458, with one extending from a first side459 and another extending from the opposite side465.
The attachment guide460 includes an attachment hole462 through which the attachment post454 may pass. In one embodiment, the attachment hole462 also allows the attachment post454 to be operatively connected to the attachment guide460. Other holes may also be configured and dimensioned in the attachment guide460, such as kickstand targeting holes464. The kickstand targeting holes464 may allow one or more instruments to pass through to engage with kickstand holes52,62 in thebone plate10, as described above.
FIGS. 48A-48C show one embodiment of the attachment post454 and threaded shaft456 in more detail. The threaded shaft456 shown inFIG. 48A is substantially similar to the threadedshaft284 described above.FIG. 48B shows a bottom perspective view of an attachment post454 in accordance with one embodiment. The attachment post454 is substantially similar to theattachment post280 described with respect toFIG. 22 above.
In this embodiment, the attachment post454 is configured to engage anunderlying bone plate10. The attachment post454 also includes one or more ball-end pins282 for engaging alignment indentations44 (shown inFIG. 1) of thebone plate10. In addition, the attachment post454 includes a threaded opening operable to receive the threaded shaft456 for threadingly attaching to aninstrument attachment hole44 in thebone plate10. In other embodiments, at least a portion of the opening in the attachment post454 may not be threaded, which provides the advantage of allowing the attachment post454 to slide over the threaded shaft456. The attachment post454 further comprises a stabilizingfeature287 that assists with alignment during attachment.
The bottom surface of the attachment post454 may be offset and contoured to match the contour of thebone plate10 at the attachment location. The attachment post454 may be operatively connected to thebone plate10 using a nut threading onto the threaded shaft456. In addition, at least a portion of the outer surface of the attachment post454 may be threaded so that it can be attached to the attachment guide460 using the attachment hole462. In this embodiment, the end of the attachment post454 distal from the end attached to thebone plate10 may be threaded and may be operatively connectable to corresponding threading on the inner surface of the attachment hole462.
As shown inFIG. 48C, an upper portion467 of the attachment post454 may include a lip466 that is configured and dimensioned along its upper end, distal from the end that is attached to thebone plate10. The upper portion467 of the attachment post454 may also be tapered such that it results in an interference fit with the attachment hole462. The attachment post454 may be secured to the attachment guide460 using an arm attachment nut468, as shown inFIG. 48C. A post attachment nut470 may also be included to secure the attachment post454 to the arm attachment nut468, the threaded shaft456, or both.
As described above, the aiming guide452 includes one or more guide holes262 that help guide one or more fasteners, screws, or other instruments into the correspondingholes62 of theplate10 with accuracy. In one embodiment, the guide holes262 of the aiming guide452 may accept one or more tissue protection sleeves472. The tissue protection sleeves472 provide a portal into small incisions through which various instruments may pass. Examples of instruments that may pass through the tissue protection sleeves472 include, but are not limited to, trocars496, drill sleeves488, DCP sleeves492, drills490, drivers, screws, and the like. The tissue protection sleeves472 may operatively connect to the guide holes262 in a desired orientation. When operatively connected to the guide holes262, the tissue protection sleeves472 allow an accurate and rigid interface with the aiming guide452.
FIGS. 49A-49B are diagrams showing exemplary tissue protection sleeves according to one embodiment of the present invention. The tissue protection sleeve472 may be inserted through aguide hole262 and then operatively connected thereto. As shown inFIG. 49A, one embodiment of the tissue protection sleeve472 may include a head474 and a tip476. The tip476 may be configured and dimensioned to fit into theholes62 of thebone plate10. The head474 may comprise a relief cut478 and a retention ledge480. The relief cut478 is configured and dimensioned such that a portion of the head474 comprises a movable arm482 that can flex between an open (expanded) and closed (compressed) position. The movable arm482 is operable to flex about a pivot point at the bottom of the relief cut478, as shown best inFIG. 49B. The movable arm482 may also include a retention ledge480 on its outer surface.
The guide holes262, according to one embodiment, may be configured and dimensioned to include complementary features that interact with the head474 of the tissue protection sleeve472. In this embodiment, eachguide hole262 may include a recess484 in a top portion of thehole262. The recess484 is configured and dimensioned to allow a bottom portion of the head474 to sit inside theguide hole262. A portion of thehole262 may also include an undercut486 that is operable to interact with the retention ledge480 configured on the movable arm482. The undercut486 may be configured and dimensioned to house the retention ledge480 when the movable arm482 is in its steady-state, expanded configuration, as shown inFIG. 49B. Similarly, the retention ledge480 may be configured and dimensioned to fit within the undercut486 in its steady-state, expanded configuration. The retention ledge480 is also configured and dimensioned such that it can move axially within thehole262 when the movable arm482 is compressed towards the head474.
When the tissue protection sleeve472 is inserted into the hole, the head474 rests inside the recess484, according to one embodiment. During insertion, the movable arm482 is compressed towards the head474, allowing the retention ledge480 to pass into thehole262. When the head474 fully rests inside the recess484, the retention ledge480 is positioned below the undercut486, allowing the arm482 to expand into its steady-state, expanded position, as shown inFIG. 49B. When inserted in this manner, tactile feedback or an audible sound, e.g., a click, may be felt or heard as the retention ledge480 grabs the undercut486. In order to release the tissue protection sleeve472, the arm482 may be compressed towards the head474, allowing the retention ledge480 to be removed from the undercut486. With the retention ledge480 no longer operatively connected to the undercut486 and restricted from axial movement, it may be moved out of thehole262.
As discussed above, a tissue protection sleeve472 provides a portal into small incisions through which various instruments may pass.FIG. 50 is a diagram showing exemplary instruments passing through tissue protection sleeves472 that have been inserted into the guide holes262 of the aiming arm458. A drill sleeve488, for example, may be inserted into the tissue protection sleeve472 and operatively connected to thebone plate10. In one embodiment, the drill sleeve488 aligns a drill490 to a center axis of thehole262. Alternatively, a DCP sleeve492 may be inserted to allow off-axis insertion of a drill490. One advantage of using an off-axis sleeve is that it allows for off-axis predrilling that can set up compression through a DCP hole that is offset in either direction. For instance, a DCP sleeve492 may allow compression of 1 mm through a DCP hole in either direction.
In other embodiments, a hole marker494 may also be inserted into ahole262 in the aiming arm458 to allow for marking of a hole. This may be advantageous, for example, to allow for marking of thelast hole262 used, or to indicate a hole which has already been filled with a device, such as a screw. Still other embodiments may allow for other devices, such as a round-tip trocar496, to be inserted into the tissue protection sleeve472. Those skilled in the art will understand that one or more tissue protection sleeves472 and corresponding devices may be using in combination with the present invention as desired. AlthoughFIG. 50 illustrates multiple tissue protection sleeves472 and devices inserted into the aiming arm458 at the same time, this is done for illustrative purposes only. One or more sleeves472 and/or other devices may be used at one time if desired. In other embodiments, only one sleeve472 and/or device maybe used at one time.
According to one embodiment, the aiming guide452 attaches to thebone plate10 using a single attachment post454 and the threaded shaft456. As described above, the attachment post454 is aligned to thebone plate10 based on the ball-end pins282 and the stabilizingfeature287. According to one embodiment, the threaded shaft456 is assembled onto theplate10 first. The attachment post454 may then slide over the threaded shaft, and the ball-end pins282 align withalignment indentations44 in thebone plate10. The stabilizingfeature287 assists with alignment during attachment of the attachment post454. The attachment post454 is then operatively connected to thebone plate10 using a nut threading onto the threaded shaft456. In this manner, the attachment post454 may be rigidly fixed to thebone plate10 and may be used as an insertion handle. The attachment guide460 slides over top of the attachment post454 and is fastened into place with the arm attachment nut468. A post attachment nut470 may be optionally used to operatively connect the attachment guide460 to at least one of the attachment post454, the arm attachment nut468, and/or the threaded shaft456.
According to one embodiment, the aiming arm452 may comprise a radiolucent material in order to prevent the obstruction of lateral imaging during a medical procedure. The “left” and “right” configurations allow for guiding insertion of screws, fasteners, or other devices through either side of abone plate10. The associated tissue protection sleeves472, drill sleeves488, and other instrumentation described herein may be used with the aiming guide452 in both the left and right configurations.
In one embodiment, the aiming guide452 may also be used with a proximal aiming guide498. In this embodiment, the proximal aiming guide498 comprises a plate that may be operatively connected to thebone plate10 separately from the aiming guide452. The proximal aiming guide498 may be used with or without the aiming guide452.FIG. 51A is a top perspective view of the proximal aiming guide452. The proximal aiming guide452 includes one or more guide holes500.
In one embodiment, the proximal aiming guide452 includes a fastening mechanism that allows it to be operatively connected to thebone plate10. For example, the proximal aiming guide452 may includeclips502 that are configured and dimensioned to allow the guide452 to be operatively connected to thebone plate10. In one embodiment, theclips502 may be formed as a part of the proximal aiming guide452. Alternately, theclips502 can be separate elements. In other embodiments,clips502 maybe formed as a part of thebone plate10. Theclips502 may be positioned near one or more edges of the proximal aiming guide452 in order to secure it to the bone plate, as shown inFIG. 51A.
The proximal aiming guide498 may also includeopenings504 that are selectively positioned in one or more different locations. Theopenings504 may be configured and dimensioned near the perimeter of the proximal aiming guide498, as shown inFIG. 51A, in order to guide the proximal aiming guide498 into the correct placement on thebone plate10. Theopenings504 may be configured to receive protrusions, such aspegs506, that facilitate the alignment of the guide holes500 and the corresponding holes in thebone plate10. In this embodiment, thepegs506 may be configured and dimensioned as part of thebone plate10. In another embodiment, thebone plate10 may include openings through which pegs that protrude from the proximal aiming guide498 may pass in order to facilitate alignment of the guide holes500 and the correspondingholes62 in thebone plate10.
FIG. 51B is a diagram showing another top perspective view of the proximal aiming guide498. When the proximal aiming guide498 is operatively connected to thebone plate10, it allows for the insertion of tools, such as drill sleeves508, through the guide holes500, as shown inFIG. 51B. The insertion of drill sleeves508 allows for the targeting of the nominal angle of the proximal holes in thebone plate10. After drilling, the drill sleeve508 may be removed and a screw or other fastener may be inserted through the proximal aiming guide498. When all fasteners, e.g., screws, have been placed, the proximal aiming guide498 may be removed. Removal of the proximal aiming guide498 may be accomplished by hand, or by using a tool such as a drill sleeve to pry it off of thebone plate10.
FIG. 28 is a front view of a bone plate including rafting screws attached to a bone member. Thebone plate10 can be any of the bone plates described above and can include fasteners orscrews6 extending therethrough. As shown in the figure, the upper row ofscrews6 can be considered rafting screws. These rafting screws not only help to treat a bone fracture, but they have to prevent subsidence near the articular joint.
FIG. 29 is a side view of the bone plate ofFIG. 28. From this view, one can see the rafting screws extending across a fracture in the bone. The rafting screws are positioned adjacent to the articular joint to prevent subsidence near the articular joint.
FIG. 30 is a top view of the bone plate ofFIG. 28. From this view, one can see how the rafting screws serve as rebar and provide support for the articular joint.
In addition to these rafting screws, which are threaded, non-threading rafting blades can be provided. In some embodiments, these non-threaded blades help to (i) provide better support of an articular surface, (ii) minimize time in surgery due to ease of insertion; and (iii) have a reduced risk of post-operative back out.
FIG. 31 is a top perspective view of a rafting blade in accordance with some embodiments. Therafting blade406 can be used in addition to, or as an alternative to, the threaded rafting screws described previously. In some embodiments, one ormore rafting blades406 can be inserted through a bone plate that has been secured to bone via one or more fasteners or screws. The one or more blades can then be locked to the bone plate to prevent post-operative back out.
Therafting blade406 comprises aproximal end412 and adistal cutting end414. Thedistal cutting end414 advantageously enables therafting blade406 to be inserted into bone with ease, simply by impacting theproximal end412 of therafting blade406. In some embodiments, therafting blade406 is curved or arced. In some embodiments, therafting blade406 is concave, thereby forming a concave rafting surface. In some embodiments, therafting blade406 comprises astructural rib422 that extends along a longitudinal axis of therafting blade406. Thestructural rib422 and concave rafting surface advantageously improve the bending moment along the length of therafting blade406, thereby providing support against failure during and after insertion.
FIG. 32 is a top view of the rafting blade ofFIG. 31. From this view, one can see how thestructural rib406 extends along a central longitudinal axis of therafting blade406. In some embodiments, thestructural rib406 extends along a majority of the length of the central longitudinal axis of therafting blade406.
FIG. 33 is a side view of the rafting blade ofFIG. 31. From this view, one can see the concave curvature of therafting blade406.
FIG. 34 is a side view of a pair of rafting blades attached to a plate in accordance with some embodiments. Theplate10 comprises a curved or domed plate contact surface that facilitates rotation in one plane allowing therafting blades406 to be inserted parallel to an articular surface regardless of plate position. In some embodiments, raftingblades406 can be inserted at a similar angle to one another. In other embodiments, raftingblades406 can be inserted at different angles from one another.
FIG. 35A is a front view of the rafting blade ofFIG. 31. From this view, one can see how therafting blade406 comprises a k-wire hole430. Therafting blade406 can be cannulated to allow guided insertion by k-wire. In some embodiments, therafting blade406 can be tapped into bone via use of a slotted hammer.
FIG. 35B is a bottom perspective view of the rafting blade ofFIG. 31. From this view, one can see the underside of therafting blade406 and its cannulated k-wire hole430.
FIG. 36 is a top perspective view of an insertion guide for rafting blades in accordance with some embodiments.FIG. 37 is a top view of the insertion guide detached from the rafting blades ofFIG. 36. Theinsertion guide500 allows for a set of parallel or variableangled rafting blades406 to be inserted simultaneously into a bone member. In other embodiments, a rafting blade can be individually installed. By accommodating a set of rafting blades, theinsertion guide500 advantageously reduces the time in surgery. In some embodiments, theinsertion guide500 comprises a block that can temporarily engage or attach to a bone plate after the bone plate has been secured to bone. The block can include a series of channels or openings through which therafting blades406 can be inserted therein. In some embodiments, a plurality ofrafting blades406 are preloaded into theinsertion guide500. In other embodiments, theinsertion guide500 can be used without preloadingrafting blades406, thereby allowing a surgeon to select lengths that best suit a particular patient. With theinsertion guide500 in place, therafting blades406 can be tapped into bone in sequence. As shown inFIG. 36, in some embodiments, three raftingblades406 can be inserted in theinsertion guide500. In some embodiments, the middle blade can be shaped in such a way to prevent back out of the other two rafting blades, as shown inFIG. 38.
FIG. 38 is a top view of the rafting blades following insertion in accordance with some embodiments. Threerafting blades406 are provided in theinsertion guide500. Theblades406 includefirst blade406a,second blade406b,andthird blade406c.Theblades406 are tapped in a particular sequence such that thethird blade406cprevents backout of the first andsecond blades406a,406b.In particular, by tappingfirst blade406aandsecond blade406bprior to tapping thethird blade406c,thethird blade406ccan be sized and configured (e.g., via its proximal head portion) to prevent inadvertent backout of thefirst blade406aand thesecond blade406b.
FIG. 39 is a top perspective view of rafting blades and an independent support screw in accordance with some embodiments. In the present embodiment, raftingblades406 that are inserted into abone plate10 throughrafting holes432 are accompanied by asupport screw506. Thesupport screw506 advantageously supports the tips of therafting blades406 after insertion.
FIG. 40A is a front view of a blocking mechanism for the rafting blades in accordance with some embodiments.FIG. 40B is a front view of the blocking mechanism ofFIG. 40A rotated. In some embodiments, theblocking mechanism520 comprises a blocking screw. In some embodiments, theblocking mechanism520 comprises a rotating member that allows insertion ofrafting blades406 in one configuration, but prevents therafting blades406 from backing out in another rotated configuration. In the embodiment inFIG. 38, in which amiddle rafting blade406cprevents backout ofadjacent rafting blades406a,406b,theblocking mechanism520 can simply be installed behind themiddle rafting blade406.
FIG. 41 is a side view of a rafting blade and locking cap in accordance with some embodiments. The locking cap advantageously prevents the rafting blade from toggling within a bone plate and keeps it within the bone plate. In some embodiments, alocking cap440 can be used to collapse over aspherical head410 of arafting blade406. The outside of thelocking cap440 can have a conical surface withcutouts442 around its diameter. In some embodiments, thecutouts442 are zig-zagged or z-shaped. In other embodiments, thecutouts442 are slits. The inside of thelocking cap440 can be spherical to allow the variable angle installation of arafting blade406. The lockingcap440 can be threaded. As thelocking cap440 is threaded into a bone plate, its conical geometry andcutouts442 allow it to collapse over thespherical head410, grip to the grooved surface of thespherical head410 and lock it into plate within a bone plate.
FIG. 42 is a top perspective view of the rafting blade attached to the locking cap ofFIG. 41. From this view, one can see how the head of therafting blade406 is received in thelocking cap440.
FIG. 43 is a top perspective view of the locking cap ofFIG. 41. From this view, one can see the inner portion of the threadedlocking cap440. In addition, one can see how thecutouts442 are formed around a perimeter of thelocking cap440. As shown inFIG. 43,cutouts442 can be initiated at a top or bottom section of thelocking cap440.
FIG. 44 is a top perspective view of a rafting blade having deforming ridges in accordance with some embodiments.FIG. 45 is a bottom perspective view of the rafting blade having deforming ridges ofFIG. 44. In some embodiments, therafting blade406 can comprises one ormore ridges450 where it contacts a bone plate. These one ormore ridges450 can cause a small amount of deformation in the bone plate as the bone plate is inserted, which would advantageously help to lock therafting blade406 in place. As shown inFIG. 44, therafting blade406 can comprise a pair ofridges450, each of which is off-center from a longitudinal axis of therafting blade406.
According to one aspect of the present invention, a radiolucent panel with radiopaque anatomic and/or mechanical references is included. The radiolucent panel may be used, for example, to assist with the intraoperative restoration of normal femoral and tibial anatomy under fluoroscopy in the operating room. As used herein, each angle is measured relative to a mechanical (m) or anatomic (a) axis. The angle may be measured medial (M), lateral (L), anterior (A), or posterior (P) to the axis line. In addition, the angle may refer to the proximal (P) or distal (D) joint orientation angle of either the femur (F) or tibia (T). For example, mLDFA as used herein refers to the mechanical lateral distal femoral angle in the frontal plane and the PPTA refers to the posterior proximal tibia angle in the sagittal plane. Additionally, the JLCA is the joint line congruency angle referring to the angle between the distal femur and the proximal tibia. The ANSA and MNAS are the anterior and medial neck shaft angles, respectively, which measure the angle between the center of the femoral neck and the proximal femoral shaft.
According to one embodiment, the present invention includes a guide that comprises a panel with one or more references. The references may include, but are not limited to, lines, points, rulers, letters, dashes, pictures, shapes, arrows, and the like. For instance, any medical reference may be included, including those known to medical professionals, e.g., surgeons or the like. In one embodiment, anatomic and mechanical axis lines may be included, for example. The exemplary guide may also include a ruler for measurements during a medical procedure. Any units of measurement may be used for the ruler, including the metric or U.S. system of measurement. The ruler may be used to measure the length of body parts, such as limbs, or alternately may be used to measure medical devices for insertion or as a frame of reference for placement of screws, fasteners, trauma treatment instruments and implants, including external fixators, ring fixators, rods, and other plates.
It may be desirable and advantageous for one embodiment of the guide to be used during medical procedures, such as intraoperative procedures. As such, one embodiment of the guide comprises a radiolucent panel. Any radiolucent material known to those skilled in the art may be used including, but not limited to, plastic, carbon, fibers, composites, and combinations thereof. In some embodiments, it may be desirable for the references included in the guide to be formed from one or more radiopaque materials. In such embodiments, at least one of the references may comprise metallic wire or radiopaque ink, for example. References such as anatomic and/or mechanical axis lines may also include metallic wire or radiopaque ink in some embodiments.
In such embodiments, the metallic wire or radiopaque ink may be positioned on an inner or outer surface of the guide. Alternately, the metallic wire or radiopaque ink may be formed as a part of the guide. It may desirable in other embodiments for the metallic wire or radiopaque ink to be formed between layers of the guide, i.e., if the guide is formed of two or more layers, the metallic wire or radiopaque ink may be positioned in between the two or more layers. When the guide is formed of two or more layers, it may be desirable to include ink on an inner or outer surface of one or more of the layers.
As discussed above, the guide may comprise a panel in one embodiment. The shape and dimensions of the panel may be varied as desired for a particular application. For instance, one embodiment of the guide510 may comprise a single rectangular panel having a length that is greater in magnitude than its width, as shown inFIG. 52. One embodiment of the guide510 may comprise a single, reversible guide that has references for left limbs on one side and right limbs on the other side. Alternately, the guide510 may be one sided and have separate guides for left limbs and right limbs.
FIG. 52 shows one exemplary embodiment of a guide according to one embodiment, as discussed above. As shown in the figure, the guide510 may comprise a panel that is reversible. In this embodiment, the guide510 may include a side reference511 that indicates the proper orientation for which side of the body it is to be used with. In theFIG. 52 embodiment, the guide510 on the left (in the figure) may be used with limbs on the left side of a person's body, while the guide510 on the right (in the figure) may be used with limbs on the right side of a person's body. The proper orientation is evident when the “left” or “right” side reference511 is legible.
The references included on the guide510 may also include anatomic and mechanical axis lines512, as shown inFIG. 52. The references may include a ruler514. As shown in theFIG. 52 embodiment, the ruler may be positioned along the perimeter of the guide510.
FIG. 53 is a diagram showing a more detailed view of a frontal plane (AP) guide mechanical and anatomic reference angles according to one embodiment. According to one embodiment, the guide510 may include several mechanical and anatomic axis lines512 or other indicators for comparison to adjacent anatomy. For example, the reference lines512 may be at their nominal normal values for comparison to the anatomy shown on a fluoroscopic image. Although the guide510 may include reference text labeling of the axes in angles in some embodiments, reference text labeling may not be included in other embodiments.
As best seen inFIG. 64, the mechanical and anatomic reference lines512 or any other indicators may be in the form of ink, wires, or the like. For example, the lines512 may be made of one or more metallic wires, metallic ink, or other radiopaque materials configured to be visible on fluoroscopy or other imaging during a surgical procedure. The guide510 may comprise a first rectangular panel510aand a second rectangular panel510b,for example, formed of a radiolucent material, comprising dimensions substantially similar to one another. The wires, ink, or other reference markers may be positioned in between the first and second rectangular panels510a,510band the first and second rectangular panels510a,510bmay be operatively connected to one another, for example, by adhesive, melting the panels together, or other suitable means. For example, the wires, ink, or other reference markers may be positioned on one of the panels510a,510bbefore sandwiching them together.
The exemplary guide510 shown inFIG. 53 may be of assistance with, for example, aligning the knee joint, the proximal and distal femur, the femoral neck, and the proximal and distal tibia. The guide510 may also enable limb length measurement during repair of a fractured limb by comparison to the contralateral anatomy. As shown inFIG. 53, the guide510 may include various references that allow for the determination of mechanical or anatomical angles.
As shown inFIG. 53, one embodiment may include reference lines512 that allow for the determination of the medial neck shaft angle (MNSA)516, which may be a comparison between two overlapping reference lines512. The MNSA may be between about 124 degrees to about 136 degrees, or about 130 degrees. In addition, guide510 may include reference lines512 that allow for the determination of the anterior medial proximal angle (aMPFA)518, which may be between about 80 degrees and about 89 degrees, or about 84 degrees. Reference lines512 may also allow for the determination of the joint line congruency angle (JLCA)520, which may be between about 0 degrees and about 2 degrees, or about 1 degree. The medial proximal tibial angle (MPTA)522 may also be measured using the references512 included in the guide510. The MPTA522 may be between about 85 degrees and about 90 degrees, or about 87 degrees, as shown inFIG. 53.
Theguide500 may include any number of references or indicators. In other embodiments, the guide510 may include reference lines512 that allow the mechanical lateral proximal femoral angle (mLPFA)524 to be measured. The mLPFA524 may range between about 85 degrees and about 95 degrees, or about 90 degrees, for example. The mechanical lateral distal femoral angle (mLDFA)526 may also be measured using reference lines512 included in the guide510, and may range between about 85 degrees and about 90 degrees, or about 88 degrees. Reference lines512 may also be included to measure the anatomic lateral distal femoral angle (aLDFA)528, which may range between about 79 degrees and about 83 degrees, or about 81 degrees. One embodiment of the guide510 also allows for the measurement of the lateral distal tibial angle (LDTA)530, which may range between about 86 degrees and about 92 degrees, or about 89 degrees.
FIGS. 54-57 are diagrams showing examples of the guide510 being used to measure anatomic angles during interoperative use.FIG. 54, for example, shows how the guide510 can be used during intraoperative use to measure the knee joint, distal femur, and proximal tibia alignment.FIG. 55 is a diagram that shows how the guide510 may be used during intraoperative use to measure the proximal femur and femoral neck alignment.FIG. 56 is a diagram that shows how the guide510 may be used during intraoperative use to measure the distal tibia alignment.FIG. 57 is a diagram that shows how the guide510 may be used during intraoperative use to perform a limb length comparison using the ruler514.
During surgical procedures, it is sometimes desirable to obtain lateral images.FIG. 58 is a diagram showing another embodiment of guide510 according to one aspect of the present invention. One embodiment of the guide510 shown inFIG. 58 comprises a sagittal plane guide that may assist with lateral imaging. The guide510 comprises similar materials to the guide described with respect toFIGS. 52-58 above. In contrast to the embodiments described inFIGS. 52-58, the references may comprise mechanical and anatomic axes at their nominal normal angles for the sagittal plane. The references may also include text labeling the axes and angles, as described above. TheFIG. 58 embodiment of guide510 may be used, for example, to align the knee joint, the proximal and distal femur, the femoral neck, and the proximal and distal tibia.
As shown inFIG. 58, the guide510 may include references that allow for the measurement of various anatomic angles. For example, reference lines512 may be included that allow the anterior neck shaft angle (ANSA)532 to be measured, and may range between about 165 degrees and about 175 degrees, or about 170 degrees. In addition, reference lines512 may be included that allow the anterior distal tibial angle (ADTA)534 to be measured, and may range between about 78 degrees and about 82 degrees, or about 80 degrees. In some embodiments, reference lines512 may be included that allow the posterior proximal femoral angle (PPFA)536 to be measured, and may range between about 88 degrees and about 92 degrees, or about 90 degrees. Reference lines512 may also be included that allow the posterior distal femoral angle (PDFA)538 to be measured, which may range between about 79 degrees and about 87 degrees, or about 83 degrees. Additionally, reference lines512 may be included that allow the posterior proximal tibia angle (PPTA)540 to be measured, which may range between about 77 degrees and about 84 degrees, or about 81 degrees.
FIGS. 59-60 are diagrams showing the guide510 ofFIG. 58 during intraoperative use.FIG. 59, for example, is a diagram that shows the guide510 being used to evaluate the proximal femur and femoral neck alignment.FIG. 60 is a diagram that shows the guide510 being used to evaluate the distal tibia alignment.
In some embodiments, the guide510 may include reference lines indicating the normal limits of the mechanical and anatomic axes.FIG. 61 is a diagram showing a guide510 that includes dotted reference lines542 indicating the limits of each mechanical and anatomic axis512. The guide510 on the left ofFIG. 61 is an exemplary frontal guide and the guide510 on the right ofFIG. 61 is an exemplary sagittal guide that include dotted reference lines542.
In various embodiments, the guides510 may come packaged together or as part of a kit. In one embodiment, a sagittal and frontal guide may be formed as a single, foldable element, as shown inFIG. 62A. In embodiments where the guides510 are foldable, the sagittal guide may be positioned at an angle, e.g., a 90 degree angle, to the frontal guide using a support, such as a bracket or the like (not shown) inFIG. 62A. One advantage of including a support is that it would facilitate holding the guides510 in place during imaging, such as lateral fluoroscopic imaging. In other embodiments, such as the embodiment shown inFIG. 62B, the frontal and sagittal guides may be positioned adjacent to one another.
In one embodiment, it may be desirable for the guides510 to be sterilized and packaged. The guides510 may comprise various shapes and dimensions, and may be packaged together with guides510 of similar shapes and dimensions or with guides510 of varying shapes and dimensions. The guides510 may be configured and dimensioned in different sizes to fit into different cases546 as a reusable guide510. To aid with sterilization, the guides510 may include one or more perforations544, as shown inFIG. 63. The perforations544 may provide the advantage of allowing sterilization, e.g., steam sterilization, for example, in a graphic case.
One skilled in the art will appreciate that the embodiments discussed above are non-limiting. While bone plates may be described as suitable for a particular approach (e.g., medial or lateral), one skilled in the art will appreciate that the bone plates can be used for multiple approaches. In addition, while bone plates are described as having particular holes (e.g., locking or non-locking), one skilled in the art will appreciate that any of the bone plates can include locking, non-locking or a combination of locking and non-locking holes. In addition to the bone plates, screws and instruments described above, one skilled in the art will appreciate that these described features can be used with a number of trauma treatment instruments and implants, including external fixators, ring fixators, rods, and other plates and screws.