Title of Invention	A TOOL AND SYSTEM FOR MANIPULATING BONE SEGMENTS HAVING INTERCONNECTED RECESS PORTIONS
Abstract	A tool is disclosed for use in distracting and compressing fractures of any of a variety of bones. In particular, the tool has a pair of engaging arms, one arm having a hook element to engage a bone plate connected to one side of a fracture, and the other arm having at least one recess for engaging a head of a bone screw or guide wire connected to the other side of the fracture. Actuation of the tool causes the opposing bone segments of the fracture to be pushed apart or drawn together, depending on whether the tool handles are squeezed together or pulled apart. The tool may have a scissors joint that allows the ends of the tool to maintain a parallel alignment during operation, thus reducing the chances for misalignment of the bone segments during operation.

Title of Invention

A TOOL AND SYSTEM FOR MANIPULATING BONE SEGMENTS HAVING INTERCONNECTED RECESS PORTIONS

Abstract

A tool is disclosed for use in distracting and compressing fractures of any of a variety of bones. In particular, the tool has a pair of engaging arms, one arm having a hook element to engage a bone plate connected to one side of a fracture, and the other arm having at least one recess for engaging a head of a bone screw or guide wire connected to the other side of the fracture. Actuation of the tool causes the opposing bone segments of the fracture to be pushed apart or drawn together, depending on whether the tool handles are squeezed together or pulled apart. The tool may have a scissors joint that allows the ends of the tool to maintain a parallel alignment during operation, thus reducing the chances for misalignment of the bone segments during operation.

Full Text	COMPRESSOR-DISTRACTOR FIELD OF THE INVENTION [0001] The present invention relates to a hand-held tool for moving bone segments with respect to each other, such as for example, for arranging a pair of opposing bone segments to be connected with a bone plate. More particularly, the invention relates to a tool used first to distract fractured bone segments so they may be properly aligned, and then to compress the aligned segments together so they may be fixed together with an orthopedic bone plate BACKGROUND OF THE INVENTION 10002) The use of bone plates for stablizing fractured bones is widely accepted. The plates are used by surgeons to stabilize, mend, or align a patient's bones as well as alter compression of patient's bones, and are typically fastened to the bones with a plurality of inscteacrs, such as screws that arc installed through holes in the plate. [0003] Prior to fixation of a fracture the surgeon typically may manipulate the bone segments to return them to proper orientation and alignment To accomplish this, the surgeon may first apply a distraction or separation force to the bone segments, which may cause the surrounding soft tissue to urge the bone segments bade toward their general pro-fracture position. The bone segments may then be individually manipulated to achieve a more precise alignment, followed by the application of a compression force to the segments to press them together to increase the likelihood that the bone segments will fuse. [0004] Thus, there is a need for an instrument that may be used to apply a distraction or compression force to fractured bones to aid in their alignment and subsequent re- SUMMARY OF THE INVENTION [0005] A tool may be provided for manipulating bone segments, die tool may comprise an actuating end may have first and second handles pivotably coupled together and an engaging end may have first and second engaging aims. The first engaging arm may have a first end coupled to the first handle and a second end configured to receive at least a portion of a bone fastener. The second engaging aim may have a first end coupled to the second handle and a second end configured to engage a bone plate. The second end of the first engaging arm farther may have at least a first lateral side surface may have a first reaction configured to receive at least a portion of the hone fastener. [0006] The bone fastener may be above screw, and the first recess maybe configured to receive a head portion of the bone screw. The first recess may have a depth of from about 0.1 mm to about 3.0 mm. Alternatively, the bone fastener may comprise a surgical guide wire, wherein the second end of the first engaging arm may comprise a second recess configured to receive at least a portion of the guide wire, the second recess may have a depth of from about 0.1 mm to about 1.8 mm. Further, the first and second recesses may be at least partially coextensive. [0007) The second end of the second engaging arm may comprise a hook configured to engage the bone plate. The hook may farther be configured to engage the end surface of the bone plate or abone screw hole of the bone plate. [0008] The bone fastener may be a surgical guide wire, wherein the second lateral side surface has a second recess configured to receive at least a portion of the guide wire. [0009] The second end of the first engaging aim farther may have at least a second lateral side surface may have a first recess configured to receive at least a portion of the bone fastener. The bone fastener may be a bone screw, and the first recess of the second lateral side surface may be configured to receive a bead portion of the bone screw. [0010] Each of the first and second handles may be coupled to one of the first and second engaging arms such that moving the first and seconds handles together moves the first and second engaging arms with respect to each other. The first and second engaging arms may be pivotably coupled to the first and second handles, respectively, [0011] A scissor-joint may be disposed between the first and second engaging arms The scissor-joint may be operable to maintain the anus oriented substantially parallel with respect to each other when 1he first and second handles are moved, The tool further may be configured such that moving the first and second handles together results in the first and second engaging arms moving apart [0012] A system is provided for manipulating first and second fractured bone segments. The system may comprise a tool comprising an actuating end with first and second handles pivotably coupled together and an engaging end having first and second engaging arms. THE first engaging arm may have a first end coupled to the first handle and a second end having a first recess configured to receive at least aportion of a bone fastener therein. The second engaging arm may have a first end coupled to the second handle and a second end configured to engage a bone plate. At least one bone fastener and a bone plate may also be provided (0013] Thus, when the bone fastener is engaged with the first bone segment and the bone plate is engaged with the second brae segment, the first and second engaging arms are engagable with the fastener and plate such that moving the first and second handles with respect to each other moves the first and second bone segments with respect to each other. [0014] The bone fastener may be a bone screw, and the first recess may be configured to receive a head portion of the bone screw. The first recess may have a depth of from about 0.1 mm to about 3.0 mm. The bone fastener may comprise a surgical guide wire,and the second tad of the first engaging arm may have a second recess configured to receive at least a portion of a surgical guide wire [0015] The second recess may have a depth of from about 0.1 mm to about 1.8 mm. The first and second recesses further may be at least partially coextensive. The second end of the second engaging arm may be a hook configured to engage the bone plate; 10016] The hook may be configured to engage at least one of an cad surface of the bone plate and a bone screw hole of the bone plate. The first engaging arm father may have a first lateral side surface and the first recess may to disposed within the first lateral side surface and configured to receive at least a portion of the bone fastener, which may to a bone screw. [0017] The first engaging arm further may have a second lateral side surface with a first recess configured to receive at least a portion of the bone fastener. The bone fastener may comprise a bone screw, and the first recesses of the first and second lateral side surfaces maybe configured to receive the head of the screw. [0018] The bone fastener may comprise a surgical guide wire, wherein the first and second lateral side surfaces each have a second recess configured to receive at least a portion of a surgical guide wire. [0019} Each of the first and second handles may be coupled to one of the first and second engaging arms such that moving the first and second handles together results in movement of the first and second engaging aims with respect to each other. The first and second engaging arms may be pivotably coupled to the first and second handles, respectively. [0020] The tool may further comprise a scissor-joint disposed between the first and second engaging arms. The scissor-joint may be operable to maintain the arms oriented substantially parallel with respect to each other when the first and second handles are moved The tool further may be configured so that moving the first and second handles together results in the first and second engaging arms moving apart [0021] A method of moving at least first and second fractured bone segments of patient with respect to each other is also provided, the method comprising the steps o£ (a) providing a tool may have an actuating end with first and second handles pivotably coupled together, the tool further having an engaging end with first and second engaging arms, the first engaging arm having a first end coupled to the first handle and a second ad configured to receive at least a portion of a bone fastener, the second engaging arm having a first end coupled to the second handle and a second end configured to engage a bone plate; wherein the first engaging aim further has at least a first lateral ride surface having a first recess configured to receive at least a portion of the hone fastener, (b) advancing the engaging aid of the tool through an incisions in the patient's skin; (c) engaging a first bone fastener with the first bone segment; (d) engaging a bone plate with the second bone segment; (c) engaging the bone fastener with the first recess of the first engaging arm;(f) engaging the bone plate with the second engaging arm; and (g) moving the first and second handles with respect to each other to move the first and second bone segments with respect to each other. [0022] The first bone fastener may be a bone screw, and the first recess may be configured to receive a head portion of the bone screw- Further, the first recess may have a depth of from about 0.1 mm to about 3.0 nm Alternatively, the first bone fastener may comprise a surgical guide wire,and the first engaging arm further may comprise a second recess configured to receive at least a portion of the guide wire. The second recess may have a depth of from about 0.1 mm to about 1.8mm. The first and second recesses may be at least partially coextensive. [0023] The method may comprise additional step (g) which comprises moving the first and second handles away from each other such that die first and second engaging arms move away from each other, thereby moving the first and second bone segments away fiom each other. [0004] The method may further comprise the steps of (h) disengaging the first engaging arm from the first bone fastener,(d) disengaging the second engaging arm from the bone plate; (e) engaging the bone fastener with the second recess of the first engaging arm; (f) engaging the bone plate with the second engaging arm; and (g) moving the first and second handles apart to thereby move the first and second bone segments together. [0025] Step(f) may comprise engaging a hook on the second engaging arm with a bone screw hole of the bone plate. The bone fastener may further be a bone screw, and the first recess of the second lateral side surface may be configured to receive a head portion of die bone screw. Alternatively, the bone fastener may c [0026} The first and second engaging arms may be pivotably coupled to the first and second handles, respectively. The tool may further comprise a scissor-joint disposed between the first and second engaging arms, the scissor-joint operable to maintain the arms oriented substantially parallel with respect to each other when the first and second handles are moved. BRIEF DESCRIPTION OF THE DRAWINGS [0027] For a better understanding of the nature and objects of the invention, reference should be made to the following detailed description, taken in conjunction with the accompanying drawings which show preferred features of the invention, in which like reference numerals refer to corresponding parts throughout the several views of the drawings and wherein: [0028] FIG. 1 is a side elevation view of a tool according to one embodiment of the present invention, with the tool shown in the closed position; [0029] FIG. 2 shows a side elevation view of the tool of FIG* 1, with the tool being shown in the open position; [0030J FIG 3 is a top view of the tool of FIG 1; [0031] FIG. 4A is a detail view of the fixation-element engaging end of the tool of [0Q32] FIG. 4B is a side partial section view of the fixation-element engaging end of the tool of FIG 1, taken along line B-B of FIG. 4A; [0033] FIG. 4C is an end section view of one of the fixation-element engaging ends of the tool of FIG.l,takcaalongline C-C of FIG.4B; [0034] FIG. 4D is a side detail view of an engaging end of the tool of FIG. 1 engaged, for purposes of illustration, with a bone screw and a guide wire; [0035] FIG&5A-C are perspective views of the tool of FIG.l engaged with a bone plateaod atone screw for distracting and then compressing a fracture; [0036] FIG 5D is a side view of the tool of FIG.l engaged with a guide wire DETAILED DESCRIPTION OF THE INVENTION [0037] Referring to FIG. 1, there is shown an examplary tool 10 adapted for distracting or compressing a pair of opposing fractured bone segments. The tool 10 may engage an orthopedic fixation element, such as a bone plate 1000 (FIG. 5A) or bone screw 1100, that is connected to one ofthc pair of segments. The tool 10 may be a generally pliers lite device having an actuating end 100 and a fixation-elements engaging end 200.The actuating end 100 may comprise a pair of opposed handles 110A, B coupled at pivot portions 130A,B. The fixation-element engaging end 200may comprise apair of engaging arms 220A, B, each having a distal engaging end210A,B configured to engage a separate orthopedic fixation elemeat such as a bone plate, bone screw or guide wire (see FIGS. 5A-5C). Engaging arms 220A,B may further each have a proximal end 222A,B, pivotably associated with a respective distal cod 140 A, B of handles 110A, B so that when the handles are squeezed together, the engaging ends 210A, B spread apart (FIG. 2). Thus, when the engaging ends 2lftA, B are engaged with bone plate 1000 and bone screw 1100 that themselves are each fixed to a respective fractured bone segment 2000,2100, (FIGS. 5A. 3e),squeezing the handles 110A,B, together may cause the bone segments to spread apart Conversely, spreading the handles 110A,B may draw the bone segments together.A biasing assembly 400 maybe provided to urge the handle 110A, B apart, and a locking assembly 500 may be provided to allow the user to lock the device in a selected position. [0038J Handles 110A, 110B may each have a proximal gripping portion 120A, B, a distal engaging-arm engaging portion 140A, B, and an into mediate pivot portion 130A, B, The gripping portion mayhaveribsll2A,112Bto facilitate gripping by the user. The pivot portions 130A, B may have a transverse hole 142A, B for receiving a fastener150 such as a pin, screw, rivet, etc therethrough to allow the handles to pivot with respect to each other, likewise, the engaging-arm engaging portions 140A,B, may each have a similar transverse hole 144A,B, for receiving a similar fastener 145AfBtopivotaUymgagetheptoximaIcod 222A, B of a respective engaging aim 220A, B. [0039] The engaging arms 220A, B may be connected together via a scissors assembly 300 that operates to maintain the arms 220A, B substantially parallel with respect to each other as they axe opened and closed. This parallel arrangement causes the engaging ends 210A, B to remain in constant alignment with the associated fixation element 1000, 1100 throughout the full range of motion of the instrument 10, thus enhancing the engagement between the instrument 10 and the fixation elements 1000,1100,1200. This arrangement also may allow the user to apply distraction, or compression motion that if substantially parallel to the longitudinal axis of the fractured bone, thus eliminating a potential source of bone segment misalignment in use. [0040] Thus, scissor assembly 300 may comprise first and second scissor aims 310, 315 each having a first end 311,316 and a second cud 312,317 and an intermediate pivot portion 313,318. The first ends 311,316 each have a transverse hole 314,319 for receiving a pin 350A, B to pivotably connect the first ends 311,316 to the first and second engaging arms 220A,B, The second ends 3152,317 each have a transversely projecting pin 332A,B configured to slide within a longitudinal slot 224A,B formed in the first and second engaging arms 220At B. The intermediate pivot portions 313,318 each has a transverse hole for receiving a pivot pui342, to allow the arms 310,315 to pivot with respect to code other. Thus arranged, when, the instrument 10 is in the closed position illustrated in FIG. 1, the scissors assembly 300 assumes a folded position in which transverely projecting pins 332A,, B art positioned adjacent the proximal end of longitudinal slots 224A, B. When the handles 110A» B arc squeezed together, an opening movement is allied to the engaging arms 220A, B via fasteners 145A, B, which causes the scissors assembly 300 to open, fixing projecting pins 332A, B to slide distally within the associated longitudinal slots 224A, B, This opening movement may continue until the handles are brought fully together or until the pins 332A, B reach thedistal ends of their associated slots 224A,B, as illustrated in FIG. 2. [0041] The instrument 10 may be sized and distraction or compression length. Thus, as illustrated in JIG, 2, the engaging arms 220a, b may have a fully open position in which the arms are separated by a maximum separation distance "mod," as measured between the centerlines of the aims. In one embodiment of the instrument 10 l or use with smaller bones such as the radius, ulna, tibia, etc., the maximum separation distance "mod" may be about 30 mm. In an alternative embodiment of the instrument 10, for use with larger bones such as the femur, the maximum separation distance may be about 60 mm As will be apparent to one of ordinary skill in the art, the instrument may to scaled to provide any appropriate separation distance, depending on the application for which the instrument is intended. [0042] It is noted that although the handles 110A, B, engaging arms 220A, 0, and scissor mechanism 300 of the instrument 10 may all be illustrated as lying in the same plane, in order to facilitate visualization of the treatment site during distraction and compression, at arms220A,B. [0043] likewise, the handles 110A,B maybe divergently flared or curved away from each other, and the length of slots 224A, B increased, to allow the engaging ends 210A, B to have a greater length of travel, thus increasing the maximum distance" mod" between the ends in the fully open position of FIG. 2. It will be apparant that the instrument may be provided with any appropriate combination of slot lengths and handle configurations to result in a desired maximum separation distance "mod." [0044] As previously noted, a locking mechanism 500 may be provided adjacent to or within the engaging end 100 to maintain a desired distraction or compression position of the instrument 10. The locking mechanism 500 may include a spindle or threaded both 510 mounted on the second handle HOB and passing through the first handle 110A. A first internally threaded speed nut 520 may rotatably mounted on the threaded bolt 510 such that movement of the speed nut 510 along the bolt selectively inhibits movement of the first handle HOB away from the second handle 110A and thus maintains the bone portions in the desired distracted position. A second speed nut 530 may also be rotatably mounted on the threaded bolt 510 between the first and second handles 110A, B such that movement of the second speed nut 530 along the bolt selectively inhibits movement of the first handle toward the second handle 110A and thus maintains the bone portions in the desired compressed position, [0045] A biasing element 400, such as a pair of leaf springs 410A, B, may further be provided to maintain handles 110A, B in a "neutral" spaced apart configuration such that engaging ends 210A, B are in the closed position of FIG. 1, ready for insertion through a small incision in the patient Locking mechanism 500 may counteract biasing element 400 as desired. 10046] The instrument 10 may also be provided with a dynamometer or force guage (not shown) disposed between handles 110A, B to allow the surgeon to preciesly determine the amount of force being applied to the bone segments using the instrnment ID. This may be important; for example, in determining whether sufficient roanpresave force is bring applied between the ends of the fractured bones to ensure proper healing, or to ensure that too much force is not being applied to the bone segments. 10047] Referring now to FIGS-4A-4C the engaging ends 210A,B of the instrument 10 will bo described in greater detail. As shown in FIGS. 4A-4C, the engaging end 210A maycomprise a hook element 212 configured to engage the end surface 1002 or the bone screw hole 10004, or articulated tensioa device hole 1005 (FIG. 5E) of a bone plate 1000 (WIG. 5A), while engaging end 210B may have s pair of recesses 218; 219 configured to receive a head portion 1102 of a bone screw 1100 (FIGS. 5A-C) or a section of a surgical guidewire 1200 (BIG.5D).This arrangement allows the device tobe used to apply a force between first and second bone segments, where the first bone segment is connected to a bone plate and the second bone segment is connected to either a bone screw or guide wire. [0048] As shown in greater detail in FIG.4B,hook element 212 may be associated with the distal end 210A of engaging arm 220A. Specifically, hook element 212 maybe connected to, and may extend distally from, the distal end 210A of engaging arm 220A. Hook 212 may have a longitudinally extending shank portion 214 with a transversely extending hook portion 216 disposed at a distal end there, The shank portion 214 may have a proximal end connected to the distal end of the engaging arm 220A. in the illustrated embodiment; the shank 214 is connected to the engaging arm 220A via a pair of machine screws 217,218. Although any appropriate fastener or fastening method may be employed for this connection (the hook could even be made an integral part of the engaging arm 220A), screws provide the advantage of allowing the hook element 216 to be easily replaced if it becomes damaged. [0049] The shank portion 214 may have an extention length "I" and a width "sw" while the hook portion 216 mayhavc a hook width "hw." Generally, die extension length "T" should be sufficient to allow the shank portion 214 to be pressed against an end 1002 of a bone plate 1000 (FIG 5A) or within a bone screw hole 1004, or articulated tension device hole 1005 (FIG. 5D) of the bone plate 1000 (FIG. 5C) without interference from the hook portico 216. In one embodiment, the extention length "I" is about 7 mm and the shank width "sw" is about 2.5 mm The hook portion 216 should be sized to allow it to be hooked under bone plate 1000 (when the instrument is used for distracting against mead of the bone plate) or to be hooked within hone screw hole 1004, or preformed hole 1005 (FIG. 5D) of the bone plate 1000 (when the instrument is used for compression) to maintain engagement of the instrument 10 with the bone plate 1000. In one embodiment; the hook width "hw" may be about 4.5 mm. [0050] As shown in FIGS. 4B and 4C, recessea218 and 219 may be formed in the lateral wall 226A, B of engaging arm 220B, and may be of substantially similar design so that a bone screw 1100 or guide wire 1200 may be engaged using either lateral side 226A, B of file instrument 10. Thus, when the device u used for distraction, recess 218 will engage the screw/wire 1100,1200, whereas when the device is used for compression, recess 219 will be engaged with the screw/wire Reference will therefore be made to recess 218 only, however, all configurations and permutations described in relation to recess 218 should be understood to apply equally to recess 219. [0051] As can be seen in FIGS. 4A and 4B, recess 218 may be comprised of two interconnected recesses 218a, b. Recess 218a may be configured to receive the head 1102 of a bone screw 1100 (FIG. 4D), while recess 218b maybe configured to receive a length of guide wire 1200 since the surgeon may use either a bone screw or guide wire to engage one of the bone segments recess 218a may have an engaging surface 1218a comprising a width "rw1"a length "r11" and a maximum depth "rd1" recess 218b likewise may have an engaging surface 1218b comprising width "rw2" a length "r12" and a maximum depth "rd2." In one embodiment, width "rw1" may be about 8 mm length "r11" may be about 7 mm and depth "rd1"may be about 4 mm; width "rw2"may be about 3 mm,"r12" may be about 26 mm and "rd2" maybe about 1.75 mm. (0052) la the illustrated embodiment, each of the recesses 218% b, 219a, b comprise cylindrical sections having a radius of curvature substantially equal to the respective recess depth "rd1""rd2" It is noted that although recesses 218a, b are described as having engaging surfaces 1218a, b comprising the aforementioned configurations and dimentions, the instrument 10 may be provided with one or more recesses with engaging surfaces having any appropriate configuration and size appropriate to engage an appropriate fastener for use in a distraction or compression operation. Further, recesses having engaging surface shapes other than the illustrated cylindrical configurations may also be used Additionally, any combination of recesses having any appropriate engaging surface shape may be used. For example, the engaging surface of each recess may be flat, triangular, elliptical, etc [0653] Moreover, the engaging surfaces 1218a, b may be smooth, or they may have surface roughenings such as projections, coatings or other surface profilings to increase engagement between the instrument 10 and an associated bone screw 1100 or guide wire 1200. [0054] Additionally, rather than providing a pair of individual recesses, a single recess maybe provided, such as to engage only a bone screw or to engage only a guide wire. Likewise, more than two recesses may be provided to engage, for example, individual multiple bone screws or individual multiple guide wires. Further, the instrument recess or recesses may be sized and configured to engage a Shant screw or Steinmann pin engaged [00551 Providing a tool 10 having engaging recesses 1218,1219 allows the instrument to be insetted through a small incision in the skin, since the fastener-engaging elements do not extend laterally beyond the engaging arms 220A,220B, an arrangement that would require additional incision length to accommodate. Thus, the present design minimizes (he ultimate incision required, which in turn reduces the total time required to perform the procedure, and also reduces scarring. A smaller incision provides a more vascular injury site, and thus results in a shorter healing time for the affected bone, limiting tile incision length also reduces disruption of (he periosteum, which is known to facilitate healing. [0056] FIGS. 5A and 5B show the tool 10 engaged with a bone plate 1000 and above screw 1100 to apply a distraction force between bone segments 2000,2100. Specifically, hook 212 engages end surface 1002 of the bone plate 1000 which is attached to bone segment 2000 while recess 218a engages the head 1102 of the bone screw 1100 which is attached to bone segment 2100. Thus applied, a squeezing force applied to the handles 110% b may cause the engaging ends 210% b of the instrument to separate, thus distracting the bone segments 2000,2100. Alternatively, as shown in FIG. 5C, 1he tool 10 is engaged with a bone screw hole 1004 of the bone plate 1000, while the recess 219a engages the head 1102 of die bone screw 1100. In this case, a separating force applied to the handles 110% b may cause the bone segments 2000,2100 to be drawn together (i.e, compressed), FIG. 5D shows the instrument 10 engaged with a length of surgical guide wire 1200 that is engaged with bone segment 2100. [0057] With reference to FIGS. 5A-5D, a method of reducing a fracture using the tool 10 of FIGS. 1-4C is also disclosed. An incision may be made in the patient's skin near the fracture, and a bone plate 1000 may be inserted through the incision so that at least a portion of the plate lies across a portion of each bone segment 2000,2001. The plate may be fixed to one bone segment 2000 using at least one bone screw 2002 Another bone screw 1100 (or guide wire 1200) maybe driven a portion of the second bone segment 2001 located a distance "d"away from the end surface 1002 of the plate 1000. The user may then insert the engaging end 200 of the tool 10 through the incition so that recess 218a engages the head portion 1002 of bone screw 1100, and the hook portion 212 engeges the end surfece 1002 of the plate 1000. In this position, the tool may be at or near its fully dosed position (FIG. 1) so as to permit easy insertion into the incision and engagement with the fixation elements 1000, 1100. The user may then squeeze the handles 110a, b of die tool together to slightly distract the bone segments. To lock (he tool 10 In this distracted position, speed nut 520 may be rotated so that it moves along threaded rod 510 md abuts handle 110* [0058] This slight distraction may allow the saloon to align bone segments 2000, 2100, and may be particularly helpful when reducing a commulated fracture involving additional smaller bone segments 2300 During the distraction step, the soft tissue surrounding the fracture may act to urge the bone segments back toward their original un-fractured position (i.e. ligamentotaxis). If accessary, forceps or other tools may also be used to realign the bone segments as desired. [0059] Once the bone segments have been realigned, the tool 10 may be repositioncd so that the hook element 212 engages a bone screw hole 1004, or articulated tension device hole 1005 (FIG. 5D), of the plate 1000, and recess 219a engages the head 1102 of bone screw 1100 (or guide wire 1200). The user may then apply a separation force between the handles 110% b to cause the engaging ends 210a, b to come together, thereby forcing the engaged bone fragments 2000,2001 to be compressed together. Again, the tool 10 may be locked in position, this time by turning speed nut 530 along threaded shaft 510 until the nut 530 contacts handle 110a, thus locking the bone segments together until the bone plate can be fixed to bone segment 2100 to fix the segment together permanently. The tool 10 may than be removed from the incision and additional procedures performed if required. [0060] While the invention has been shown and described herein with reference to particular embodiments, it is to be understood modifications of form, structure, arrangement, proportions, materials, and components and otherwise, used in the practice and which are particularly adapted to specific environments and operative requirements, may be made to the described embodiments without departing from the spirit and scope of the present invention. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited to the feregoing description. CLAIMS What is claimed is: 1. A tool for manipulating bone segments, comprising an actuating cod haying first and second handles pivotably coupled together; an engaging end having first and second engaging arms, the first engaging arm having a first end coupled to the first handle and a second end configured to reed vest least a portion of a bone fastener, the second engaging aim having a first end coupled to the second handle and a second end configured to engage a bone plate; wherein the second end of full first engaging aim further-has at least a first lateral also surface having a first recess configured to receive at least a portion of the bone fastener. 2. The tool of claim 1,wherein the bone fastener is a bone screw and the first recess is configured to receive a head portion of the bone screw. 3. The tool of claim 2, wherein the first recess has a depth of from about 0.1 mm to about 3.0mm. 4. The tool of claim 1, the bone fastener comprising a surgical guide wire, wherein the second end of the first engaging arm comprises a second recess configured to receive at least a portion of the guide wire. 5. The tool of claim 4, wherein the second recess has a depth of from about 0.1 mm to about 1.8 mm. 6. The tool of claim 4, wherein the first and second recesses are at least partially coextensive. 7. The tool of claim 6, wherein the second end of the second engaging arm comprises a hook configured to engage the bone plate: 8. The tool of claim 7, wherein the hook is configured to engage at least one of an end surface of the bone plate and a bone screw hole of the bone plate. 9. The tool of claim 8, the bone fastener comprising a surgical guide wire, wherein the second lateral side surface has a second recess configured to receive at least a portion of the guide wire. 10. The tool of claim 1, the second end of the first engaging arm farther having at least a second lateral side surface having a first recess configured to receive at least a portion of the bone fastener 11. The tool of claim 9, wherein the bone fastener is a bone screw. 12. The tool of claim 10, wherein the final recess of the second lateral side surface is configured to receive a head portion of the bone screw. 13. The tool of claim 1, wherein each of the first and second handles is coupled to one of the first and second engaging arms such that moving the first and second handles together moves the first and second engaging arms with respect to each other. 14. The tool of claim 13, wherein the first and second engaging arms are pivotably coupled to the first and second handles, respectively. 15. The tool of claim 14, further comprising a scissor-joint disposed between the first and second engaging arms, the scissor-joint operable to maintain the arms oriented substantially parallel with respect to each other when the fort and second handles are moved. 16. The tool of claim 15, the tool further configured such that moving the first and second handles together results in the first and second engaging aims moving apart 17. A system for manipulating first and second fractured bone segments, comprising a tool comprising: an actuating aid with first and second handles pivotably coupled together; an engaging end having first and second engaging arms, the first engaging arm having a first end coupled to the first handle and a second end having a first recess configured to receive at least a portion of a bone fastener therein, the second engaging arm having a first end coupled to the second handle and a second end configured to engage a bone plate; at least one bone fastener; and a bone plate; wherein where the bone fastener is engaged with the first bone segment and the bone plate is engaged with the second bone segment; the first and second engaging arms are engagable with the fastener and plate such that moving the first and second handles with respect to each other moves the first and second bone segments with respect to each other. 18. The tool of claim 17, wherein the bone fastener is a bone screw, and the first recess is configured to receive ahead portion of the bone screw. 19. The tool of claim 18, wherein the first recess has a depth of from about 0.1 mm to about 3-0 mm. 20. The tool of claim 17, the bone fastener comprising a surgical guide wire, wherein the second end of the first engaging aim comprises a second recess configured to receive at least a portion of a surgical guide wire. 21. the tool of claim 20, wherein and second recess has a depth of from about 0.1 mm to about 1.8 nun. 22. The tool of claim 20, wherein the first and second recesses are at least partially coextensive. 23. the tool of claim 22, wherein the second end of the second engaging arm comprises a hook configured to engage the bone plate. 24. The tool of claim 23, wherein the hook is configured to engage at least one of an end surface of the bone plate and a bone screw hole of the bone plate. 25. the tool of claim 17, the first engaging arm tether having a first lateral side surface, the first recess disposed within the first lateral side surface and configured to receive at least a portion of the bone fastener. 26. The tool of claim 25, wherein the bone fastener is a bone screw. 27. The tool of claim 25, the first engaging arm further having a second lateral side surface having a first recess configured to receive at least a portion of the bone fastener. 28. The tool of claim 27, the bone fastener comprising a bone screw, wherein the first recesses of the first and second lateral side surfaces are configured to receive the head of the screw. 29. The tool of claim 25, the bone fastener comprising a surgical guide wire, wherein the first and second lateral side surfaces each have a second recess configured to receive at least a portion of a surgical guide wire. 30. The tool or claim 17, wherein each of the first and second handles is coupled to one of the first and second engaging arm such that moving the first and second handles together results in movement of the first and second engaging arms with respect to each other. 31. The tool of claim 30, wherein the first and second engaging arms are pivotably coupled to the first and second handles, respectively. 32. The to of claim 31, further comprising a scissor-joint disposed between the first and second engaging arms, the scissor-joint operable to maintain the arms oriented substantially parallel with respect to each other when the first and second handles are moved. 33. The tool of claim 32, the tool further configured so that moving the first and second handles together results in the first and second engaging arms moving apart 34. A method of moving at least first and second fractured bone segments of patient with respect to each other comprising the steps of: (a) providing a tool having an actuating end with first and second handles pivotably coupled together; the tool further having an engaging end with first and second engaging aims, the first engaging aim having a first end coupled to the first handle and a second end configured to receive at least a portion of a bone fastener, the second engaging arm having a first end coupled to the second handle and a second end configured to engage a bone plate; wherein the first engaging arm further has at least a first lateral side surface having a first recess configured to receive at least a portion of the bone fastener; (b) advancing the engaging end of the tool through an incision in the patient's skin; (c) engaging a first bone fastener with the first bone segment; (d) engaging a bone plate with the second bone segment (e) Engaging the bone fastener with the first recess of the first engaging arm; (f) engaging the bone plate with the second engaging arm; and (g) moving the first and second handles with respect to each other to move the first and second bone segments with respect to each other. 35. the method of claim 34, wherein the first bone fastener is a bone screw, and the first recess is configured to receive a head portion of the bone screw. 36. The method of claim 35, wherein the first recess has a depth of from about 0.1 mm to about 3.0 mm. 37. The method of claim 34, the first bone fastener comprising a surgical guide wire, wherein the first engaging arm further comprises a second recess configured to receive at least a portion of the guide wire. 33. The method of claim 37, wherein the second recess has a depth of from about 0,1 mm to about 1.8 mm. 39. The method of claim 37, wherein the first and second recesses are at least partially coextensive. 40. The method of claim 37, wherein step (g) further comprises moving the first and second handles away from each other such that the first and second engaging arms move away from each other, thereby moving the first and second bone segments away from each other. 41. The method of claim 40, further comprising the steps of (h) disengaging the first engaging arm from the first bone fastener, (d) disengaging the second engaging arm from the bone plate; (c) engaging the bone fastener with the second recess of the first engaging arm; (f) engaging the bone plate with the second engaging arm; and (g) moving the first and second handles apart to thereby move the first and second bone segments together. 42. The method of claim 41, wherein step (f) comprises engaging a hook on the second engaging arm with a bone screw hole of fee bone plate. 43. The method of claim 42, wherein the bone fastener comprises a bone screw, 44. The method of claim 43, wherein the first recess of the second lateral side surface is configured to receive a head portion of the bone screw, 45. the method of claim 41, wherein the bone fastener comprises a surgical guide wire 46. the method of claim 34, wherein the first and second engaging arms are pivotebly coupled to the first and second handles, respectively. 47. The method of claim 35, the tool further comprising a scissor-joint disposed between the first and second engaging arms the scissor-joint operable to maintain the arms oriented substantially parallel with respect to each other where the first and second handles axe moved. Dated this 2 day of February 2007

Full Text

COMPRESSOR-DISTRACTOR
FIELD OF THE INVENTION
[0001] The present invention relates to a hand-held tool for moving bone segments
with respect to each other, such as for example, for arranging a pair of opposing bone
segments to be connected with a bone plate. More particularly, the invention relates to a tool
used first to distract fractured bone segments so they may be properly aligned, and then to compress the aligned segments together so they may be fixed together with an orthopedic
bone plate
BACKGROUND OF THE INVENTION
10002) The use of bone plates for stablizing fractured bones is widely accepted. The
plates are used by surgeons to stabilize, mend, or align a patient's bones as well as alter
compression of patient's bones, and are typically fastened to the bones with a plurality of
inscteacrs, such as screws that arc installed through holes in the plate.
[0003] Prior to fixation of a fracture the surgeon typically may manipulate the bone
segments to return them to proper orientation and alignment To accomplish this, the surgeon
may first apply a distraction or separation force to the bone segments, which may cause the
surrounding soft tissue to urge the bone segments bade toward their general pro-fracture
position. The bone segments may then be individually manipulated to achieve a more precise
alignment, followed by the application of a compression force to the segments to press them
together to increase the likelihood that the bone segments will fuse.
[0004] Thus, there is a need for an instrument that may be used to apply a distraction
or compression force to fractured bones to aid in their alignment and subsequent re-

SUMMARY OF THE INVENTION
[0005] A tool may be provided for manipulating bone segments, die tool may
comprise an actuating end may have first and second handles pivotably coupled together and an engaging end may have first and second engaging aims. The first engaging arm may have a first end coupled to the first handle and a second end configured to receive at least a portion of a bone fastener. The second engaging aim may have a first end coupled to the second handle and a second end configured to engage a bone plate. The second end of the first engaging arm farther may have at least a first lateral side surface may have a first reaction configured to receive at least a portion of the hone fastener.
[0006] The bone fastener may be above screw, and the first recess maybe configured
to receive a head portion of the bone screw. The first recess may have a depth of from about 0.1 mm to about 3.0 mm. Alternatively, the bone fastener may comprise a surgical guide wire, wherein the second end of the first engaging arm may comprise a second recess configured to receive at least a portion of the guide wire, the second recess may have a depth of from about 0.1 mm to about 1.8 mm. Further, the first and second recesses may be at least partially coextensive.
[0007) The second end of the second engaging arm may comprise a hook configured
to engage the bone plate. The hook may farther be configured to engage the end surface of the bone plate or abone screw hole of the bone plate.
[0008] The bone fastener may be a surgical guide wire, wherein the second lateral
side surface has a second recess configured to receive at least a portion of the guide wire.
[0009] The second end of the first engaging aim farther may have at least a second
lateral side surface may have a first recess configured to receive at least a portion of the bone fastener. The bone fastener may be a bone screw, and the first recess of the second lateral side surface may be configured to receive a bead portion of the bone screw.

[0010] Each of the first and second handles may be coupled to one of the first and
second engaging arms such that moving the first and seconds handles together moves the first
and second engaging arms with respect to each other. The first and second engaging arms
may be pivotably coupled to the first and second handles, respectively,
[0011] A scissor-joint may be disposed between the first and second engaging arms
The scissor-joint may be operable to maintain the anus oriented substantially parallel with
respect to each other when 1he first and second handles are moved, The tool further may be
configured such that moving the first and second handles together results in the first and
second engaging arms moving apart
[0012] A system is provided for manipulating first and second fractured bone
segments. The system may comprise a tool comprising an actuating end with first and second
handles pivotably coupled together and an engaging end having first and second engaging
arms. THE first engaging arm may have a first end coupled to the first handle and a second
end having a first recess configured to receive at least aportion of a bone fastener therein.
The second engaging arm may have a first end coupled to the second handle and a second
end configured to engage a bone plate. At least one bone fastener and a bone plate may also
be provided
(0013] Thus, when the bone fastener is engaged with the first bone segment and the
bone plate is engaged with the second brae segment, the first and second engaging arms are
engagable with the fastener and plate such that moving the first and second handles with
respect to each other moves the first and second bone segments with respect to each other.
[0014] The bone fastener may be a bone screw, and the first recess may be configured
to receive a head portion of the bone screw. The first recess may have a depth of from about
0.1 mm to about 3.0 mm. The bone fastener may comprise a surgical guide wire,and the
second tad of the first engaging arm may have a second recess configured to receive at least

a portion of a surgical guide wire
[0015] The second recess may have a depth of from about 0.1 mm to about 1.8 mm.
The first and second recesses further may be at least partially coextensive. The second end of
the second engaging arm may be a hook configured to engage the bone plate;
10016] The hook may be configured to engage at least one of an cad surface of the
bone plate and a bone screw hole of the bone plate. The first engaging arm father may have
a first lateral side surface and the first recess may to disposed within the first lateral side
surface and configured to receive at least a portion of the bone fastener, which may to a bone
screw.
[0017] The first engaging arm further may have a second lateral side surface with a
first recess configured to receive at least a portion of the bone fastener. The bone fastener
may comprise a bone screw, and the first recesses of the first and second lateral side surfaces
maybe configured to receive the head of the screw.
[0018] The bone fastener may comprise a surgical guide wire, wherein the first and
second lateral side surfaces each have a second recess configured to receive at least a portion
of a surgical guide wire.
[0019} Each of the first and second handles may be coupled to one of the first and
second engaging arms such that moving the first and second handles together results in
movement of the first and second engaging aims with respect to each other. The first and
second engaging arms may be pivotably coupled to the first and second handles, respectively.
[0020] The tool may further comprise a scissor-joint disposed between the first and
second engaging arms. The scissor-joint may be operable to maintain the arms oriented substantially parallel with respect to each other when the first and second handles are moved The tool further may be configured so that moving the first and second handles together results in the first and second engaging arms moving apart

[0021] A method of moving at least first and second fractured bone segments of
patient with respect to each other is also provided, the method comprising the steps o£ (a)
providing a tool may have an actuating end with first and second handles pivotably coupled
together, the tool further having an engaging end with first and second engaging arms, the
first engaging arm having a first end coupled to the first handle and a second ad configured
to receive at least a portion of a bone fastener, the second engaging arm having a first end
coupled to the second handle and a second end configured to engage a bone plate; wherein
the first engaging aim further has at least a first lateral ride surface having a first recess
configured to receive at least a portion of the hone fastener, (b) advancing the engaging aid
of the tool through an incisions in the patient's skin; (c) engaging a first bone fastener with
the first bone segment; (d) engaging a bone plate with the second bone segment; (c)
engaging the bone fastener with the first recess of the first engaging arm;(f) engaging the
bone plate with the second engaging arm; and (g) moving the first and second handles with
respect to each other to move the first and second bone segments with respect to each other.
[0022] The first bone fastener may be a bone screw, and the first recess may be
configured to receive a head portion of the bone screw- Further, the first recess may have a depth of from about 0.1 mm to about 3.0 nm Alternatively, the first bone fastener may comprise a surgical guide wire,and the first engaging arm further may comprise a second
recess configured to receive at least a portion of the guide wire. The second recess may have a depth of from about 0.1 mm to about 1.8mm. The first and second recesses may be at least partially coextensive.
[0023] The method may comprise additional step (g) which comprises moving the
first and second handles away from each other such that die first and second engaging arms move away from each other, thereby moving the first and second bone segments away fiom each other.

[0004] The method may further comprise the steps of (h) disengaging the first
engaging arm from the first bone fastener,(d) disengaging the second engaging arm from the
bone plate; (e) engaging the bone fastener with the second recess of the first engaging arm;
(f) engaging the bone plate with the second engaging arm; and (g) moving the first and
second handles apart to thereby move the first and second bone segments together.
[0025] Step(f) may comprise engaging a hook on the second engaging arm with a
bone screw hole of the bone plate. The bone fastener may further be a bone screw, and the first recess of the second lateral side surface may be configured to receive a head portion of die bone screw. Alternatively, the bone fastener may c
[0026} The first and second engaging arms may be pivotably coupled to the first and
second handles, respectively. The tool may further comprise a scissor-joint disposed between the first and second engaging arms, the scissor-joint operable to maintain the arms oriented substantially parallel with respect to each other when the first and second handles are moved.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] For a better understanding of the nature and objects of the invention, reference
should be made to the following detailed description, taken in conjunction with the
accompanying drawings which show preferred features of the invention, in which like
reference numerals refer to corresponding parts throughout the several views of the drawings
and wherein:
[0028] FIG. 1 is a side elevation view of a tool according to one embodiment of the
present invention, with the tool shown in the closed position;
[0029] FIG. 2 shows a side elevation view of the tool of FIG* 1, with the tool being
shown in the open position;
[0030J FIG 3 is a top view of the tool of FIG 1;
[0031] FIG. 4A is a detail view of the fixation-element engaging end of the tool of

[0Q32] FIG. 4B is a side partial section view of the fixation-element engaging end of
the tool of FIG 1, taken along line B-B of FIG. 4A;
[0033] FIG. 4C is an end section view of one of the fixation-element engaging ends
of the tool of FIG.l,takcaalongline C-C of FIG.4B;
[0034] FIG. 4D is a side detail view of an engaging end of the tool of FIG. 1
engaged, for purposes of illustration, with a bone screw and a guide wire;
[0035] FIG&5A-C are perspective views of the tool of FIG.l engaged with a bone
plateaod atone screw for distracting and then compressing a fracture;
[0036] FIG 5D is a side view of the tool of FIG.l engaged with a guide wire
DETAILED DESCRIPTION OF THE INVENTION
[0037] Referring to FIG. 1, there is shown an examplary tool 10 adapted for
distracting or compressing a pair of opposing fractured bone segments. The tool 10 may engage an orthopedic fixation element, such as a bone plate 1000 (FIG. 5A) or bone screw 1100, that is connected to one ofthc pair of segments. The tool 10 may be a generally pliers lite device having an actuating end 100 and a fixation-elements engaging end 200.The
actuating end 100 may comprise a pair of opposed handles 110A, B coupled at pivot portions 130A,B. The fixation-element engaging end 200may comprise apair of engaging arms 220A, B, each having a distal engaging end210A,B configured to engage a separate orthopedic fixation elemeat such as a bone plate, bone screw or guide wire (see FIGS. 5A-5C). Engaging arms 220A,B may further each have a proximal end 222A,B, pivotably associated with a respective distal cod 140 A, B of handles 110A, B so that when the handles are squeezed together, the engaging ends 210A, B spread apart (FIG. 2). Thus, when the engaging ends 2lftA, B are engaged with bone plate 1000 and bone screw 1100 that themselves are each fixed to a respective fractured bone segment 2000,2100, (FIGS. 5A.

3e),squeezing the handles 110A,B, together may cause the bone segments to spread apart
Conversely, spreading the handles 110A,B may draw the bone segments together.A biasing
assembly 400 maybe provided to urge the handle 110A, B apart, and a locking assembly
500 may be provided to allow the user to lock the device in a selected position.
[0038J Handles 110A, 110B may each have a proximal gripping portion 120A, B, a
distal engaging-arm engaging portion 140A, B, and an into mediate pivot portion 130A, B,
The gripping portion mayhaveribsll2A,112Bto facilitate gripping by the user. The pivot
portions 130A, B may have a transverse hole 142A, B for receiving a fastener150 such as a pin, screw, rivet, etc therethrough to allow the handles to pivot with respect to each other, likewise, the engaging-arm engaging portions 140A,B, may each have a similar transverse hole 144A,B, for receiving a similar fastener 145AfBtopivotaUymgagetheptoximaIcod 222A, B of a respective engaging aim 220A, B.
[0039] The engaging arms 220A, B may be connected together via a scissors
assembly 300 that operates to maintain the arms 220A, B substantially parallel with respect to each other as they axe opened and closed. This parallel arrangement causes the engaging ends 210A, B to remain in constant alignment with the associated fixation element 1000, 1100 throughout the full range of motion of the instrument 10, thus enhancing the engagement between the instrument 10 and the fixation elements 1000,1100,1200. This arrangement also may allow the user to apply distraction, or compression motion that if substantially parallel to the longitudinal axis of the fractured bone, thus eliminating a potential source of bone segment misalignment in use.
[0040] Thus, scissor assembly 300 may comprise first and second scissor aims 310,
315 each having a first end 311,316 and a second cud 312,317 and an intermediate pivot portion 313,318. The first ends 311,316 each have a transverse hole 314,319 for receiving a pin 350A, B to pivotably connect the first ends 311,316 to the first and second engaging

arms 220A,B, The second ends 3152,317 each have a transversely projecting pin 332A,B
configured to slide within a longitudinal slot 224A,B formed in the first and second engaging

arms 220At B. The intermediate pivot portions 313,318 each has a transverse hole for
receiving a pivot pui342, to allow the arms 310,315 to pivot with respect to code other.
Thus arranged, when, the instrument 10 is in the closed position illustrated in FIG. 1, the
scissors assembly 300 assumes a folded position in which transverely projecting pins 332A,,
B art positioned adjacent the proximal end of longitudinal slots 224A, B. When the handles
110A» B arc squeezed together, an opening movement is allied to the engaging arms 220A,
B via fasteners 145A, B, which causes the scissors assembly 300 to open, fixing projecting
pins 332A, B to slide distally within the associated longitudinal slots 224A, B, This opening
movement may continue until the handles are brought fully together or until the pins 332A, B
reach thedistal ends of their associated slots 224A,B, as illustrated in FIG. 2.
[0041] The instrument 10 may be sized and
distraction or compression length. Thus, as illustrated in JIG, 2, the engaging arms 220a, b may have a fully open position in which the arms are separated by a maximum separation distance "mod," as measured between the centerlines of the aims. In one embodiment of the instrument 10 l or use with smaller bones such as the radius, ulna, tibia, etc., the maximum separation distance "mod" may be about 30 mm. In an alternative embodiment of the instrument 10, for use with larger bones such as the femur, the maximum separation distance may be about 60 mm As will be apparent to one of ordinary skill in the art, the instrument may to scaled to provide any appropriate separation distance, depending on the application for which the instrument is intended.
[0042] It is noted that although the handles 110A, B, engaging arms 220A, 0, and
scissor mechanism 300 of the instrument 10 may all be illustrated as lying in the same plane, in order to facilitate visualization of the treatment site during distraction and compression, at

arms220A,B.
[0043] likewise, the handles 110A,B maybe divergently flared or curved away from
each other, and the length of slots 224A, B increased, to allow the engaging ends 210A, B to
have a greater length of travel, thus increasing the maximum distance" mod" between the
ends in the fully open position of FIG. 2. It will be apparant that the instrument may be
provided with any appropriate combination of slot lengths and handle configurations to result
in a desired maximum separation distance "mod."
[0044] As previously noted, a locking mechanism 500 may be provided adjacent to or
within the engaging end 100 to maintain a desired distraction or compression position of the
instrument 10. The locking mechanism 500 may include a spindle or threaded both 510 mounted on the second handle HOB and passing through the first handle 110A. A first internally threaded speed nut 520 may rotatably mounted on the threaded bolt 510 such that movement of the speed nut 510 along the bolt selectively inhibits movement of the first handle HOB away from the second handle 110A and thus maintains the bone portions in the desired distracted position. A second speed nut 530 may also be rotatably mounted on the threaded bolt 510 between the first and second handles 110A, B such that movement of the second speed nut 530 along the bolt selectively inhibits movement of the first handle toward the second handle 110A and thus maintains the bone portions in the desired compressed position,
[0045] A biasing element 400, such as a pair of leaf springs 410A, B, may further be
provided to maintain handles 110A, B in a "neutral" spaced apart configuration such that engaging ends 210A, B are in the closed position of FIG. 1, ready for insertion through a small incision in the patient Locking mechanism 500 may counteract biasing element 400 as desired.

10046] The instrument 10 may also be provided with a dynamometer or force guage
(not shown) disposed between handles 110A, B to allow the surgeon to preciesly determine
the amount of force being applied to the bone segments using the instrnment ID. This may be important; for example, in determining whether sufficient roanpresave force is bring applied between the ends of the fractured bones to ensure proper healing, or to ensure that too much force is not being applied to the bone segments.
10047] Referring now to FIGS-4A-4C the engaging ends 210A,B of the
instrument 10 will bo described in greater detail. As shown in FIGS. 4A-4C, the engaging end 210A maycomprise a hook element 212 configured to engage the end surface 1002 or
the bone screw hole 10004, or articulated tensioa device hole 1005 (FIG. 5E) of a bone plate
1000 (WIG. 5A), while engaging end 210B may have s pair of recesses 218; 219 configured
to receive a head portion 1102 of a bone screw 1100 (FIGS. 5A-C) or a section of a surgical
guidewire 1200 (BIG.5D).This arrangement allows the device tobe used to apply a force
between first and second bone segments, where the first bone segment is connected to a bone
plate and the second bone segment is connected to either a bone screw or guide wire.
[0048] As shown in greater detail in FIG.4B,hook element 212 may be associated
with the distal end 210A of engaging arm 220A. Specifically, hook element 212 maybe connected to, and may extend distally from, the distal end 210A of engaging arm 220A. Hook 212 may have a longitudinally extending shank portion 214 with a transversely extending hook portion 216 disposed at a distal end there, The shank portion 214 may have a proximal end connected to the distal end of the engaging arm 220A. in the illustrated embodiment; the shank 214 is connected to the engaging arm 220A via a pair of machine screws 217,218. Although any appropriate fastener or fastening method may be employed for this connection (the hook could even be made an integral part of the engaging arm 220A), screws provide the advantage of allowing the hook element 216 to be easily replaced if it

becomes damaged.
[0049] The shank portion 214 may have an extention length "I" and a width "sw"
while the hook portion 216 mayhavc a hook width "hw." Generally, die extension length "T"
should be sufficient to allow the shank portion 214 to be pressed against an end 1002 of a
bone plate 1000 (FIG 5A) or within a bone screw hole 1004, or articulated tension device
hole 1005 (FIG. 5D) of the bone plate 1000 (FIG. 5C) without interference from the hook
portico 216. In one embodiment, the extention length "I" is about 7 mm and the shank width
"sw" is about 2.5 mm The hook portion 216 should be sized to allow it to be hooked under
bone plate 1000 (when the instrument is used for distracting against mead of the bone plate)
or to be hooked within hone screw hole 1004, or preformed hole 1005 (FIG. 5D) of the bone
plate 1000 (when the instrument is used for compression) to maintain engagement of the
instrument 10 with the bone plate 1000. In one embodiment; the hook width "hw" may be
about 4.5 mm.
[0050] As shown in FIGS. 4B and 4C, recessea218 and 219 may be formed in the
lateral wall 226A, B of engaging arm 220B, and may be of substantially similar design so
that a bone screw 1100 or guide wire 1200 may be engaged using either lateral side 226A, B
of file instrument 10. Thus, when the device u used for distraction, recess 218 will engage
the screw/wire 1100,1200, whereas when the device is used for compression, recess 219 will
be engaged with the screw/wire Reference will therefore be made to recess 218 only,
however, all configurations and permutations described in relation to recess 218 should be
understood to apply equally to recess 219.
[0051] As can be seen in FIGS. 4A and 4B, recess 218 may be comprised of two
interconnected recesses 218a, b. Recess 218a may be configured to receive the head 1102 of
a bone screw 1100 (FIG. 4D), while recess 218b maybe configured to receive a length of
guide wire 1200 since the surgeon may use either a bone screw or guide wire to engage one

of the bone segments recess 218a may have an engaging surface 1218a comprising a width
"rw1"a length "r11" and a maximum depth "rd1" recess 218b likewise may have an
engaging surface 1218b comprising width "rw2" a length "r12" and a maximum depth
"rd2." In one embodiment, width "rw1" may be about 8 mm length "r11" may be about 7
mm and depth "rd1"may be about 4 mm; width "rw2"may be about 3 mm,"r12" may be
about 26 mm and "rd2" maybe about 1.75 mm.
(0052) la the illustrated embodiment, each of the recesses 218% b, 219a, b comprise
cylindrical sections having a radius of curvature substantially equal to the respective recess
depth "rd1""rd2" It is noted that although recesses 218a, b are described as having
engaging surfaces 1218a, b comprising the aforementioned configurations and dimentions,
the instrument 10 may be provided with one or more recesses with engaging surfaces having
any appropriate configuration and size appropriate to engage an appropriate fastener for use
in a distraction or compression operation. Further, recesses having engaging surface shapes
other than the illustrated cylindrical configurations may also be used Additionally, any
combination of recesses having any appropriate engaging surface shape may be used. For
example, the engaging surface of each recess may be flat, triangular, elliptical, etc
[0653] Moreover, the engaging surfaces 1218a, b may be smooth, or they may have
surface roughenings such as projections, coatings or other surface profilings to increase
engagement between the instrument 10 and an associated bone screw 1100 or guide wire
1200.
[0054] Additionally, rather than providing a pair of individual recesses, a single
recess maybe provided, such as to engage only a bone screw or to engage only a guide wire.
Likewise, more than two recesses may be provided to engage, for example, individual
multiple bone screws or individual multiple guide wires. Further, the instrument recess or
recesses may be sized and configured to engage a Shant screw or Steinmann pin engaged

[00551 Providing a tool 10 having engaging recesses 1218,1219 allows the
instrument to be insetted through a small incision in the skin, since the fastener-engaging
elements do not extend laterally beyond the engaging arms 220A,220B, an arrangement that
would require additional incision length to accommodate. Thus, the present design
minimizes (he ultimate incision required, which in turn reduces the total time required to
perform the procedure, and also reduces scarring. A smaller incision provides a more
vascular injury site, and thus results in a shorter healing time for the affected bone, limiting
tile incision length also reduces disruption of (he periosteum, which is known to facilitate
healing.
[0056] FIGS. 5A and 5B show the tool 10 engaged with a bone plate 1000 and above
screw 1100 to apply a distraction force between bone segments 2000,2100. Specifically, hook 212 engages end surface 1002 of the bone plate 1000 which is attached to bone segment 2000 while recess 218a engages the head 1102 of the bone screw 1100 which is attached to bone segment 2100. Thus applied, a squeezing force applied to the handles 110% b may cause the engaging ends 210% b of the instrument to separate, thus distracting the bone segments 2000,2100. Alternatively, as shown in FIG. 5C, 1he tool 10 is engaged with a bone screw hole 1004 of the bone plate 1000, while the recess 219a engages the head 1102 of die bone screw 1100. In this case, a separating force applied to the handles 110% b may cause the bone segments 2000,2100 to be drawn together (i.e, compressed), FIG. 5D shows the instrument 10 engaged with a length of surgical guide wire 1200 that is engaged with bone segment 2100.
[0057] With reference to FIGS. 5A-5D, a method of reducing a fracture using the
tool 10 of FIGS. 1-4C is also disclosed. An incision may be made in the patient's skin near the fracture, and a bone plate 1000 may be inserted through the incision so that at least a

portion of the plate lies across a portion of each bone segment 2000,2001. The plate may be
fixed to one bone segment 2000 using at least one bone screw 2002 Another bone screw
1100 (or guide wire 1200) maybe driven a portion of the second bone segment 2001 located
a distance "d"away from the end surface 1002 of the plate 1000. The user may then insert
the engaging end 200 of the tool 10 through the incition so that recess 218a engages the head
portion 1002 of bone screw 1100, and the hook portion 212 engeges the end surfece 1002 of
the plate 1000. In this position, the tool may be at or near its fully dosed position (FIG. 1) so
as to permit easy insertion into the incision and engagement with the fixation elements 1000,
1100. The user may then squeeze the handles 110a, b of die tool together to slightly distract
the bone segments. To lock (he tool 10 In this distracted position, speed nut 520 may be
rotated so that it moves along threaded rod 510 md abuts handle 110*
[0058] This slight distraction may allow the saloon to align bone segments 2000,
2100, and may be particularly helpful when reducing a commulated fracture involving additional smaller bone segments 2300 During the distraction step, the soft tissue surrounding the fracture may act to urge the bone segments back toward their original un-fractured position (i.e. ligamentotaxis). If accessary, forceps or other tools may also be used to realign the bone segments as desired.
[0059] Once the bone segments have been realigned, the tool 10 may be repositioncd
so that the hook element 212 engages a bone screw hole 1004, or articulated tension device hole 1005 (FIG. 5D), of the plate 1000, and recess 219a engages the head 1102 of bone screw 1100 (or guide wire 1200). The user may then apply a separation force between the handles 110% b to cause the engaging ends 210a, b to come together, thereby forcing the engaged bone fragments 2000,2001 to be compressed together. Again, the tool 10 may be locked in position, this time by turning speed nut 530 along threaded shaft 510 until the nut 530 contacts handle 110a, thus locking the bone segments together until the bone plate can be

fixed to bone segment 2100 to fix the segment together permanently. The tool 10 may than
be removed from the incision and additional procedures performed if required.
[0060] While the invention has been shown and described herein with reference to
particular embodiments, it is to be understood
modifications of form, structure, arrangement, proportions, materials, and components and otherwise, used in the practice and which are particularly adapted to specific environments and operative requirements, may be made to the described embodiments without departing from the spirit and scope of the present invention. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited to the feregoing description.

CLAIMS
What is claimed is:
1. A tool for manipulating bone segments, comprising
an actuating cod haying first and second handles pivotably coupled together; an engaging end having first and second engaging arms, the first engaging arm having a first end coupled to the first handle and a second end configured to reed vest least a portion of a bone fastener, the second engaging aim having a first end coupled to the second handle and a second end configured to engage a bone plate;
wherein the second end of full first engaging aim further-has at least a first lateral also surface having a first recess configured to receive at least a portion of the bone fastener.
2. The tool of claim 1,wherein the bone fastener is a bone screw and the first recess is
configured to receive a head portion of the bone screw.
3. The tool of claim 2, wherein the first recess has a depth of from about 0.1 mm to
about 3.0mm.
4. The tool of claim 1, the bone fastener comprising a surgical guide wire, wherein the
second end of the first engaging arm comprises a second recess configured to receive
at least a portion of the guide wire.
5. The tool of claim 4, wherein the second recess has a depth of from about 0.1 mm to
about 1.8 mm.
6. The tool of claim 4, wherein the first and second recesses are at least partially
coextensive.

7. The tool of claim 6, wherein the second end of the second engaging arm comprises a
hook configured to engage the bone plate:
8. The tool of claim 7, wherein the hook is configured to engage at least one of an end
surface of the bone plate and a bone screw hole of the bone plate.
9. The tool of claim 8, the bone fastener comprising a surgical guide wire, wherein the second lateral side surface has a second recess configured to receive at least a portion of the guide wire.
10. The tool of claim 1, the second end of the first engaging arm farther having at least a
second lateral side surface having a first recess configured to receive at least a portion
of the bone fastener
11. The tool of claim 9, wherein the bone fastener is a bone screw.
12. The tool of claim 10, wherein the final recess of the second lateral side surface is
configured to receive a head portion of the bone screw.
13. The tool of claim 1, wherein each of the first and second handles is coupled to one of
the first and second engaging arms such that moving the first and second handles
together moves the first and second engaging arms with respect to each other.
14. The tool of claim 13, wherein the first and second engaging arms are pivotably
coupled to the first and second handles, respectively.
15. The tool of claim 14, further comprising a scissor-joint disposed between the first and
second engaging arms, the scissor-joint operable to maintain the arms oriented
substantially parallel with respect to each other when the fort and second handles are
moved.

16. The tool of claim 15, the tool further configured such that moving the first and second
handles together results in the first and second engaging aims moving apart
17. A system for manipulating first and second fractured bone segments, comprising
a tool comprising:
an actuating aid with first and second handles pivotably coupled
together;
an engaging end having first and second engaging arms, the first engaging arm having a first end coupled to the first handle and a second end having a first recess configured to receive at least a portion of a bone fastener therein, the second engaging arm having a first end coupled to the second handle and a second end configured to engage a bone plate; at least one bone fastener; and
a bone plate;
wherein where the bone fastener is engaged with the first bone segment and the bone plate is engaged with the second bone segment; the first and second engaging arms are engagable with the fastener and plate such that moving the first and second handles with respect to each other moves the first and second bone segments with respect to each other.
18. The tool of claim 17, wherein the bone fastener is a bone screw, and the first recess is
configured to receive ahead portion of the bone screw.
19. The tool of claim 18, wherein the first recess has a depth of from about 0.1 mm to
about 3-0 mm.
20. The tool of claim 17, the bone fastener comprising a surgical guide wire, wherein the
second end of the first engaging aim comprises a second recess configured to receive
at least a portion of a surgical guide wire.

21. the tool of claim 20, wherein and second recess has a depth of from about 0.1 mm to
about 1.8 nun.
22. The tool of claim 20, wherein the first and second recesses are at least partially
coextensive.
23. the tool of claim 22, wherein the second end of the second engaging arm comprises a
hook configured to engage the bone plate.
24. The tool of claim 23, wherein the hook is configured to engage at least one of an end
surface of the bone plate and a bone screw hole of the bone plate.
25. the tool of claim 17, the first engaging arm tether having a first lateral side surface,
the first recess disposed within the first lateral side surface and configured to receive
at least a portion of the bone fastener.
26. The tool of claim 25, wherein the bone fastener is a bone screw.
27. The tool of claim 25, the first engaging arm further having a second lateral side
surface having a first recess configured to receive at least a portion of the bone
fastener.
28. The tool of claim 27, the bone fastener comprising a bone screw, wherein the first
recesses of the first and second lateral side surfaces are configured to receive the head
of the screw.
29. The tool of claim 25, the bone fastener comprising a surgical guide wire, wherein the
first and second lateral side surfaces each have a second recess configured to receive
at least a portion of a surgical guide wire.

30. The tool or claim 17, wherein each of the first and second handles is coupled to one of
the first and second engaging arm such that moving the first and second handles together results in movement of the first and second engaging arms with respect to each other.
31. The tool of claim 30, wherein the first and second engaging arms are pivotably coupled to the first and second handles, respectively.
32. The to of claim 31, further comprising a scissor-joint disposed between the first and
second engaging arms, the scissor-joint operable to maintain the arms oriented
substantially parallel with respect to each other when the first and second handles are
moved. 33. The tool of claim 32, the tool further configured so that moving the first and second
handles together results in the first and second engaging arms moving apart 34. A method of moving at least first and second fractured bone segments of patient with
respect to each other comprising the steps of:
(a) providing a tool having an actuating end with first and second handles
pivotably coupled together; the tool further having an engaging end with first and second engaging aims, the first engaging aim having a first end coupled to the first handle and a second end configured to receive at least a portion of a bone fastener, the second engaging arm having a first end coupled to the second handle and a second end configured to engage a bone plate;
wherein the first engaging arm further has at least a first lateral side surface having a
first recess configured to receive at least a portion of the bone fastener;
(b) advancing the engaging end of the tool through an incision in the patient's
skin;
(c) engaging a first bone fastener with the first bone segment;

(d) engaging a bone plate with the second bone segment
(e) Engaging the bone fastener with the first recess of the first engaging arm;
(f) engaging the bone plate with the second engaging arm; and
(g) moving the first and second handles with respect to each other to move the
first and second bone segments with respect to each other.

35. the method of claim 34, wherein the first bone fastener is a bone screw, and the first
recess is configured to receive a head portion of the bone screw.
36. The method of claim 35, wherein the first recess has a depth of from about 0.1 mm to
about 3.0 mm.
37. The method of claim 34, the first bone fastener comprising a surgical guide wire,
wherein the first engaging arm further comprises a second recess configured to
receive at least a portion of the guide wire.
33. The method of claim 37, wherein the second recess has a depth of from about 0,1 mm to about 1.8 mm.
39. The method of claim 37, wherein the first and second recesses are at least partially
coextensive.
40. The method of claim 37, wherein step (g) further comprises moving the first and
second handles away from each other such that the first and second engaging arms
move away from each other, thereby moving the first and second bone segments away
from each other.
41. The method of claim 40, further comprising the steps of
(h) disengaging the first engaging arm from the first bone fastener,

(d) disengaging the second engaging arm from the bone plate;
(c) engaging the bone fastener with the second recess of the first engaging arm;
(f) engaging the bone plate with the second engaging arm; and
(g) moving the first and second handles apart to thereby move the first and second
bone segments together.
42. The method of claim 41, wherein step (f) comprises engaging a hook on the second
engaging arm with a bone screw hole of fee bone plate.
43. The method of claim 42, wherein the bone fastener comprises a bone screw,
44. The method of claim 43, wherein the first recess of the second lateral side surface is
configured to receive a head portion of the bone screw,
45. the method of claim 41, wherein the bone fastener comprises a surgical guide wire
46. the method of claim 34, wherein the first and second engaging arms are pivotebly
coupled to the first and second handles, respectively.
47. The method of claim 35, the tool further comprising a scissor-joint disposed between
the first and second engaging arms the scissor-joint operable to maintain the arms
oriented substantially parallel with respect to each other where the first and second handles axe moved.
Dated this 2 day of February 2007

Documents:

465-CHENP-2007 AMENDED CLAIMS 14-08-2013.pdf

465-CHENP-2007 AMENDED PAGES OF SPECIFICATION 14-08-2013.pdf

465-CHENP-2007 ASSIGNMENT 14-08-2013.pdf

465-CHENP-2007 CORRESPONDENCE OTHERS 20-08-2013.pdf

465-CHENP-2007 CORRESPONDENCE OTHERS 22-02-2013.pdf

465-CHENP-2007 CORRESPONDENCE OTHERS 21-07-2014.pdf

465-CHENP-2007 EXAMINATION REPORT REPLY RECEIVED 14-08-2013.pdf

465-CHENP-2007 FORM-1 14-08-2013.pdf

465-CHENP-2007 FORM-3 14-08-2013.pdf

465-CHENP-2007 OTHER PATENT DOCUMENT 14-08-2013.pdf

465-CHENP-2007 OTHER PATENT DOCUMENT 1 14-08-2013.pdf

465-CHENP-2007 AMENDED CLAIMS 22-08-2014.pdf

465-CHENP-2007 AMENDED PAGES OF SPECIFICATION 22-08-2014.pdf

465-CHENP-2007 EXAMINATION REPORT REPLY RECEIVED 22-08-2014.pdf

465-CHENP-2007 FORM-1 22-08-2014.pdf

465-chenp-2007-abstract.pdf

465-chenp-2007-assignement.pdf

465-chenp-2007-claims.pdf

465-chenp-2007-correspondnece-others.pdf

465-chenp-2007-description(complete).pdf

465-chenp-2007-drawings.pdf

465-chenp-2007-form 1.pdf

465-chenp-2007-form 26.pdf

465-chenp-2007-form 3.pdf

465-chenp-2007-form 5.pdf

465-chenp-2007-pct.pdf

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Patent Number

264125

Indian Patent Application Number

465/CHENP/2007

PG Journal Number

50/2014

Publication Date

12-Dec-2014

Grant Date

08-Dec-2014

Date of Filing

02-Feb-2007

Name of Patentee

SYNTHES GMBH

Applicant Address

EIMASTRASSE 3, CH-4436 OBERDORF,

Inventors:

#	Inventor's Name	Inventor's Address
1	DIDOMENICO, SCOTT	628 BELLFLOWER BOULEVARD, WARRINGTON, PA 18976,
2	CHAN, JASON, S	1919 AUDUBON DRIVE, DRESHER, PA 19025, USA
3	MAST, JEFF, W	3405 SOUTHAMPTON DRIVE, RENO, NV 89509, USA
4	MAYO, KEITH, A	3614 FOREST BEACH DRIVE, NW, GIG HARBOR, WA 98335, USA
5	BOLHOFNER, BRETT, R	4600 4TH STREET NORTH, ST. PETERSBURG, FL 33703, USA

PCT International Classification Number

A61B 17/56

PCT International Application Number

PCT/US05/23626

PCT International Filing date

2005-06-30

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	10/884,704	2004-07-02	U.S.A.