Patent ID: 12207857

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices, systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. The devices, systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments. The features illustrated or described in connection with one embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed devices and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such devices and methods. Equivalents to such linear and circular dimensions can be determined for different geometric shapes. Further, like-numbered components of the embodiments can generally have similar features. Still further, sizes and shapes of the devices, and the components thereof, can depend at least on the anatomy of the subject in which the devices will be used, the size and shape of objects with which the devices will be used, and the methods and procedures in which the devices will be used.

Instruments and methods are disclosed herein for bending or contouring an implant, e.g., for use in a surgical procedure. Implant benders (also referred to herein as rod benders) of the present disclosure can include a plurality of bending elements that can be symmetrically driven by a compound gear train to bend or contour an implant. A single handle or lever can be actuated by a user, either manually or robotically assisted, to drive the gear train and move the plurality of bending elements symmetrically in a first direction. After a desired contour angle, i.e., a desired bend radius, of the implant is achieved, a locking pawl can be released to permit return of the bending elements to a starting position. Instruments of the present disclosure can impart a greater mechanical advantage and a greater displacement of the bending elements than conventional rod-benders. This can expand the range of implants that can be contoured using instruments and methods of the present disclosure to materials that have too high a yield strength for bending with conventional rod benders.

FIGS.1and2illustrate one embodiment of a rod bender instrument100of the present disclosure having a housing102, an actuator handle104, and two bending elements106a,106b. The actuator handle104can drive a gear train300(seeFIG.4A) to move the first and second bending elements106a,106bto bend or contour a rod10or other implant received within an implant-receiving channel108(seeFIG.2) of the instrument100. The bending elements106a,106bcan extend through slots105,107in the housing102and can move symmetrically across the implant-receiving channel108. The implant-receiving channel108can be defined, at least in part, by the bending elements106a,106band a support structure110such that an implant within the implant-receiving channel108can be held, at least in part, between the bending elements106a,106band the support structure. In some embodiments, one or both of the bending elements106a,106band/or the support structure110can include retention feature(s) that can, at least in part, retain the rod10or other implant within the implant-receiving channel108. For example, in some embodiments one or both of the support structures110can include a cutout or notch106ac,106bc(seeFIG.2) that can engage with a surface of the rod10to hold the rod in place. Additionally, or alternatively, the support structure110can have an outer surface with a concave shape or complementary contour to the rod10or other implant received within the implant-receiving channel108that can retain the rod therein. As can be seen inFIG.1, the bending elements106a,106bcan contact the rod10received within the implant-receiving channel108on a first side10pthereof, while the support structure110can contact the rod on a second side10dopposite the first side. A longitudinal axis A1 of the implant-receiving channel108can extend substantially perpendicular to an axis of symmetry A2 that can extend through the support structure110. The axis of symmetry A2 can define an axis about which the bending elements106a,106bmove symmetrically to bend the rod10. In some embodiments, the axis of symmetry A2 can extend along a proximal-distal axis of the housing102, i.e., a longitudinal axis of the instrument102, and the rod-receiving channel108can extend substantially perpendicular to the proximal-distal axis. The longitudinal axis of the housing102(also referred to as the proximal-distal axis of the housing) can extend from a first or proximal end102pof the housing to a second or distal end102dof the housing. The first or proximal portion102pof the housing can be formed from a main body102aof the housing and the second or distal end102dof the housing can be formed from a gripping portion102bof the housing. Construction of the housing102is discussed in further detail below.

FIG.1illustrates the bending elements106a,106bin a first or initial position, with the bending elements106a,106blocated at a proximal end105p,107pof respective slots105,107. The actuator handle104can be moved to drive the gear train300(seeFIG.4A) to symmetrically move the bending elements106a,106bdistally within the slots105,107. As described in detail below, a proximal end104pof the actuator handle104can be pivotally coupled to the housing102such that a driving pawl104pof the actuator handle is in contact with the gear train300. Moving a distal end104dof the actuator handle towards the housing102can cause the driving pawl104pto rotate the gear train300and move the bending elements106a,106bsymmetrically about the support structure110. The bending elements106a,106bcan intersect the implant-receiving channel108with distal movement within the slots105,107and exert a bending force on the rod10received within the implant-receiving channel108. A locking pawl112can selectively prevent proximal movement of the bending elements106a,106b. The locking pawl112can extend through the housing102and can be released to permit proximal movement of the bending elements106a,106b, e.g., to return the bending elements to the first position.

The instrument100can have a mechanical advantage greater than about 20, greater than about 30, or greater than about 40. The mechanical advantage provided by instruments of the present disclosure can be up to at least 7 times greater than conventional implant-bending instruments, which can allow a user to bend an implant while exerting less force than previously required. Further, the bending displacement can be 2 times or more than conventional implant-bending instruments, which can allow a user to bend an implant to a greater degree or angle. Moreover, the implant bending instruments of the present disclosure can be used to bend or contour implants made from material with a strength too high to be bent using convention implant-bending instruments. Examples of such materials can include various Nickel-Cobalt alloys, Molybdenum Rhenium alloys, and Cobalt-Chromium alloys, though others are possible as well. As discussed in detail below, instruments of the present disclosure can be used to bend an implant to a contour angle α2 of between about 180° and about 40°. To achieve contouring of the implant10, each of the bending elements106a,106bcan move symmetrically along an arcuate path between a minimum bending angle α1 min and a maximum bending angle α1 max. As discussed in detail below, α1 min can correspond to a first or initial position of the bending elements106a,106while α1 max can correspond to a second or final position of the bending elements106a,106b(see, for example,FIG.10). In some embodiments, the angle α1 can range from about 10° to about 70°. In some embodiments, the implant bending instrument100can have a height H, measured from the proximal end102pof the housing102to the distal end102dof the housing, of about 415 mm and a width W, measured perpendicular to the H, of about 338 mm.

Turning toFIG.2, the housing102can have a front panel102fand a rear panel102rwith an interior space formed therebetween. A main body102aof the housing102can hold the gear train300(seeFIG.4A) and provide attachment points for the bending elements106a,106band support structure110. The slots105,107can be formed in the main body102aof the front panel102fof the housing102and, in some embodiments, can be formed towards a proximal end102pof the housing102. The bending elements106a,106bcan extend through the slots105,107such that the bending elements protrude from the front panel102fof the housing. Similarly, the support structure110can extend through a bore120(seeFIG.3) formed in the front panel102fThe implant-receiving channel108can be formed against a front face of the front panel102fA gripping portion102bof the housing can extend distally from the main body102ato form a stationary handle that can be used in combination with the movable actuator handle104in a trigger-like fashion. The actuator handle104can be pivotally connected to the housing102at a pivot point114such that the actuator handle104can pivot towards and away from the gripping portion102bwhile the gripping portion remains stationary. In some embodiments, the pivot point114can be formed in a distal portion of the main body102a. An opening116can be formed in the housing102through which a portion of the locking pawl112can extend to allow selective release of the locking pawl. In the illustrated embodiment ofFIG.2, the opening116is formed in the front panel102fof the housing102. Alternatively, the opening116can be formed, in whole or in part, in the rear panel102r.

FIG.3is an exploded view of the instrument100ofFIGS.1and2, which makes visible components of the gear train300contained within the main portion102aof the housing102. The gear train300can include a plurality of compound gears302,304,306, a first gear wing308, and a second gear wing310. The housing panels102f,102rcan have bores118that can receive pins (not shown) to mount and retain the compound gears302,304,306within the housing102. The actuator handle104can include a housing104hand a driving pawl104pthat can extend proximally from the handle housing. The actuator handle104can be mounted to the housing102of the instrument100such that the driving pawl104pcontacts the first compound gear302(also referred to herein as the ratchet wheel) to rotate the first compound gear and drive the gear train300. The pivot point114that pivotally couples the actuator handle104to the housing102can align with the mounting bore118for the ratchet wheel302such that the actuator handle is pivotally mounted about the center point of the gear.

The locking pawl112can extend into the housing102, e.g., through the opening116in the front panel102fof the housing, such that a proximal end112pof the locking pawl contacts the ratchet wheel302(seeFIG.4A). More particularly, the proximal end of the locking pawl112pcan contact a gear tooth of the ratchet wheel302(seeFIG.4A) and serve as a rotation stop to prevent unintended counter-rotation of the ratchet wheel302, i.e., in a direction opposite the direction of rotation when the ratchet wheel302is driven by the actuator handle104. Bores119can be formed in the front and rear panels of the housing102f,102rto receive a mounting pin (not shown) to hold the locking pawl112within the housing102. A distal end112dof the locking pawl112can act as a lever and extend outside the housing102to selectively release the locking pawl112and permit counter-rotation of the ratchet wheel302. In this manner, the gear train300can be driven in reverse to move the bending elements106a,106bproximally within the respective slots105,107. As can be more clearly seen inFIGS.4A and4B, the locking pawl112and the driving pawl104pcan contact the ratchet gear302at remote locations, i.e., spaced apart from one another. For example, with the handle104in the initial or resting position, the locking pawl112pcan contact the ratchet gear302on a first side of a proximal-distal axis A3 that extends through the center point of the ratchet gear302while the driving pawl104pcan contact the ratchet gear302on a second side of the axis A3 opposite the first side.

The first and second bending elements106a,106bcan be coupled to the first and second gear wings308,310, respectively. The bending elements106a,106bcan each include a roller body106ab,106bband a mounting pin106ap,106bp. The mounting pins106ap,106bpcan extend through a lumen in the respective roller bodies106ab,106bband through a first mounting bore308a,310ain the respective gear wings308,310, to couple the bending element thereto. The gear wings308,310can also include a second bore308b,310bthat can receive a mounting pin110pof the support structure110. More particularly, the mounting pin110pof the support structure110can extend through a body110bof the support structure, a mounting bore120in the front housing panel102f, the second bores308b,310bof the first and second gear wings308,310, and a mounting bore120in the rear housing panel102r. The body110bof the support structure110can extend from the front panel102fof the housing. In some embodiments, the mounting pin110pcan mount the support structure body110bto the housing102such that a face of the support structure body110bsits flush against the front housing panel102f. The body110bof the support structure110and the roller bodies106ab,106bbof the bending elements106can have a height suitable to retain an implant within the implant-receiving channel108formed between the bending elements106a,106band the support structure110(seeFIG.2). The height of the bodies110b,106ab,106bbcan be measured as the distance that the support structure and bending elements106ab,106bb, respectively, extend perpendicular to a front surface102fsof the front panel housing102f.

Turning now to the gear wings308,310, the first gear wing308can have a proximal end308pand a distal end308dwith a plurality of gear teeth308tformed at the distal end. The first and second bores308a,308bcan each be a through bore that extends from a front face308fof the first gear wing308through a rear face308rof the first gear wing (seeFIG.4B). The first bore308acan be formed in the proximal end308pof the first gear wing. The second bore308bcan be more centrally located on the first gear wing308than the first bore308a. As discussed in detail below, the gear teeth308tof the first gear wing308can engage with the third compound gear306of the gear train300to rotate the first gear wing about a rotation axis A4. The second gear wing310can have a proximal end310pand a distal end310dwith a plurality of gear teeth310tformed at the distal end. The first and second bores310a,310bcan each be a through bore extending from a front face310fof the second gear wing310through a rear face310rof the gear wing (seeFIG.4B). The gear teeth310tof the second gear wing310can engage with the second compound gear304of the gear train300to rotate the second gear wing310about the rotation axis A4. The first and second gear wings308,310can be symmetrically mounted (seeFIG.5) such that the first and second gear wings mirror one another within the housing102. Further, in some embodiments the first and second gear wings308,310can be the same size, including pitch diameter of gear teeth308t,310tformed thereon, etc. As can best be seen inFIGS.7and8, the first and second gear wings308,310can be flush with one another such that at least a portion of the rear face308rof the first gear wing308contacts a portion of the front face310fof the second gear wing310.

As discussed in detail below, the first and second gear wings308,310can be mounted within the housing102such that the second bores308b,310bof the wings are co-axial with one another. In some embodiments, the first and second gear wings308,310can be symmetrically mounted relative to the axis of symmetry A2. The gear wings308,310can rotate symmetrically about the rotation axis A4 that can extend co-axially along the longitudinal axes of the second bores308b,310b. Accordingly, the bending elements106a,106bcoupled to the gear wings308,310, respectively, can rotate symmetrically about the rotation axis A4. Put another way, the bending elements106a,106bcan move symmetrically about the support structure110as the mounting pin110pextends through the second bores308b,310bof the wings. As can be seen inFIG.2, the bending elements106a,106bcan intersect the implant-receiving channel108as the bending elements rotate about the support structure110within the respective slots105,107. An example of this movement can also be seen by comparingFIGS.1and9versus10, withFIGS.1and9showing the bending elements106a,106bin a first configuration that accepts a straight rod10, andFIG.10showing the bending elements moved to intersect the channel108and thereby cause a bending of the rod10about the bending elements and the support structure110. In this manner, the roller bodies106ab,106bbof the bending elements106a,106bcan symmetrically bend or contour an implant received within the implant-receiving channel108about the support structure110.

The gear train300will now be described in further detail with reference toFIGS.4A-8.FIG.4Ais a front perspective view of the rod-bending instrument100ofFIG.1with the front panel102fof the housing102removed.FIG.4Bis a rear perspective view of the rod-bending instrument100ofFIG.1with the rear panel102rof the housing102removed.FIGS.5and6are front views of the main body portion102aof the instrument100with the front panel102fof the housing removed.FIG.7is a side view of the gear train300of the rod-bending instrument100ofFIG.1andFIG.8is a side cross-sectional view of the main body portion102ataken along the axis A2 fromFIG.1(or, put another way, along a longitudinal axis of the mounting pin110pof the support structure110).

Each of the compound gears302,304,306can have a major gear302a,304a,306afixed to a minor gear302b,304b306bsuch that the major gear and minor gear of a single compound gear rotate in the same direction and at the same speed. The driving pawl104pof the actuator handle104can contact the major gear302aof the first compound gear302, the ratchet wheel, to drive the first compound gear302in a first direction R1. For ease of illustration, the housing104hof the actuator handle104is not shown inFIGS.3-5such that the contact between the driving pawl104pand the major gear302aof the ratchet wheel302can be seen. Gear teeth of the minor gear302bof the ratchet wheel302can mesh with gear teeth of the major gear304aof the second compound gear304(also referred to herein as the first reducer gear). The minor gear302bof the ratchet wheel can thus drive the major gear304aof the first reducer gear304in a second direction R2 opposite the first direction R1. In the illustrated embodiment, the first direction R1 can be clockwise and the second direction R2 can be counterclockwise. In other embodiments, the first direction R1 can be counterclockwise and the second direction R2 can be clockwise. As can best be seen inFIG.5, the major gear304aof the first reducer gear304can mesh with the major gear306aof the third compound gear306(also referred to herein as the second reducer gear) such that rotation of the major gear304aof the first reducer gear304in the second direction R2 can drive rotation of the major gear306aof the second reducer gear306in the first direction R1. Further, in some embodiments the first and second reducer gears304,306can be identical, including pitch diameter of gear teeth, etc.

Turning now to the gear wings308,310, the first gear wing308can engage with the minor gear306bof the second reducer gear306and the second gear wing310can engage with the minor gear304bof the first reducer gear304. The gear teeth308tof the first gear wing308can mesh with the minor gear306bof the second reducer gear306to rotate the first gear wing about the rotation axis A4. Accordingly, the bending element106acoupled to the first gear wing308by the mounting pin106apcan move along an arcuate path B1 with rotation of the first gear wing308about the rotation axis A4. The gear teeth310tof the second gear wing310can mesh with the minor gear304bof the first reducer gear304to rotate the second gear wing310about the rotation axis A4. Accordingly, the bending element106bcoupled to the second gear wing310by the mounting pin106bpcan move along an arcuate path B2 with rotation of the second gear wing310about the rotation axis A4.

As can be seen inFIGS.4A,4B, and5, the first and second gear wings308,310can be symmetrically mounted such that the first and second gear wings mirror one another within the housing102and the first and second bending elements106a,106bcan move along symmetrical arcuate paths B1, B2. When mounted in the housing102, the second bore308bof the first gear wing308and the second bore310bof the second gear wing310can be co-axial such that the mounting pin110pof the support structure110extends through the second bore308b,310bof both the first and second gear wings308,310(seeFIGS.7and8). Thus, the first and second gear wings, and the respective bending elements106b,106acoupled thereto, rotate about the common rotation axis A4 in a symmetrical manner. The minor gear304bof the first reducer gear304, which rotates in the second direction R2, can mesh with gear teeth310tof the second gear wing310such that rotation of the minor gear304bin the second direction can rotate the second gear wing310in the first direction R1. Similarly, the minor gear306bof the second reducer gear306, which rotates in the first direction R1, can mesh with gear teeth308tof the first gear wing308such that rotation of the minor gear306bin the first direction can rotate the first gear wing308in the second direction R2. The first and second bending elements106a,106bcan travel along the symmetric arcuate paths B1, B2 in opposite directions from one another with the rotation of the first and second gear wings308,310.

The first gear wing308can include a cutout308cthat can serve as a mechanical stop for distal movement of the second bending element106b. Likewise, the second gear wing310can include a cutout310c(seeFIG.4B) that can serve as a mechanical stop for distal movement of the first bending element106a. In the illustrated embodiment, the cutouts308c,310ccan be U-shaped recesses that can mimic a rounded shape of the bending elements106a,106bsuch that the bending elements106a,106bcan be received or seated within the respective cutouts310c,308c. More particularly, the distal end308d(seeFIG.4A) of the first gear wing308and the distal end310d(seeFIG.4B) of the second gear wing310can each move proximally along their respective rotational paths about the rotation axis A4 while the bending elements106a,106bcoupled to the proximal ends310p,308p(seeFIG.4B) of the second and first gear wings310,308, respectively, move distally. The second bending element106bcoupled to the second gear wing310can move distally until movement of the second bending element is halted through contact with the cutout308cof the first bending wing308. Similarly, and simultaneously, the first bending element106acoupled to the first gear wing308can move distally until movement of the first bending element is halted through contact with the cutout310cof the second bending wing310. The distal ends105d,107dof the slots105,107can be formed in the front panel102fto align with the mechanical stops310c,308cof the gear wings310,308at the location where the bending elements106a,106bcontact the mechanical stops. This location can be distal to or below the implant-receiving channel108and the distal side10dof the rod10received within the implant-receiving channel108in an unbent or initial position, e.g., as shown inFIGS.1and9. In this manner, movement of the bending elements106a,106bdistally along the arcuate paths B1, B2 can exert a distal bending force on the rod10, or other implant, received within the implant-receiving channel108.

Operation of the rod bending instrument100will now be described with respect toFIGS.9and10.FIG.9illustrates the rod-bending instrument100ofFIG.1in the first or start position, with the bending elements106a,106blocated at the proximal ends105p,107pof the slots105,107and the rod10received within the implant-receiving channel108in an unbent or initial configuration, and the front housing panel102fremoved.FIG.10illustrates the rod-bending instrument100ofFIG.1in the second or final position, with the bending elements106a,106blocated at the distal ends105d,107dof the slots105,107and the implant10contoured or bent accordingly, and the front housing panel102fremoved. In the initial position ofFIG.9, the implant10can be placed within the implant-receiving channel108such that the bending elements106a,106bare located on the first or proximal side10pof the implant and the support structure110is located on the second or distal side of the implant. The bending elements106a,106band support structure110can, at least in part, stabilize the implant10within the implant-receiving channel108. The locking pawl112can be in its resting position, i.e., with the proximal end112pof the locking pawl in contact with a gear tooth of the ratchet wheel302. The actuator handle104and driving pawl104pare also in the resting position, with the driving pawl104pengaged with the ratchet wheel302. In the illustrated embodiment, both the locking pawl112and the driving pawl104pcontact the major gear302aof the ratchet wheel302.

The actuator handle104can be moved toward the stationary handle portion of the housing such that the driving pawl104protates the major gear302aof the ratchet wheel302in the first direction R1 to drive the gear train300. For example, a user can grip the housing of the handle104hand depress the actuator handle104towards the grip portion of the housing102b. The actuator handle104can thus rotate about the pivot point114in the first direction R1 which, in turn, can drive the major gear302aof the ratchet wheel302in the first direction R1 as a result of the contact between the driving pawl104pand the major gear302a. The locking pawl112can permit rotation of the major gear302ain the first direction R1. The major gear302acan drive the gear train300as discussed above such that the first gear wing308rotates in the second direction R2 and the second gear wing310rotates in the first direction R1. This can move the first and second bending elements106a,106bfrom the first position towards the second position (seeFIG.10). More particularly, the bending elements106a,106bcan move distally along symmetric arcuate paths B1, B2 (seeFIG.9) within the slots105,107. The bending elements106a,106bcan be moved distally until each bending element contacts the mechanical stop310c,308cformed in the opposite gear wing310,308and the bending elements106a,106bare located at the distal end105d,107dof the slots105,107(seeFIG.10).

The rod10received within the implant-receiving channel108can be bent or contoured by the distal force exerted onto the rod10by the bending elements106a,106bas the bending elements106a,106bmove distally along the arcuate path B1, B2. The support structure110can serve as a pivot point for bending of the rod10such that the rod can be bent inwards towards the axis of symmetry A2 that extends through the support structure110. As noted above, the axis of symmetry A2 can extend perpendicular to the rod receiving channel108.

Moving the bending elements106a,106bfrom the first position (seeFIG.9) to the second position (seeFIG.10) can require more than one actuation or depression of the actuator handle104. In other words, a single depression of the actuator handle104can serve to move the bending elements106a,106bdistally a partial length of the slots105,107. The actuator handle104can be released after a full depression. The actuator handle104can be biased such that, upon release, the actuator handle returns to the initial or resting position ofFIG.1. The locking pawl112can prevent counterrotation of the ratchet wheel302upon release and return of the actuator handle104to the initial position. Because the gear train300can remain stationary during release and return of the actuator handle104, the bending elements106a,106bcan hold their position within the slots105,107. Accordingly, upon a subsequent movement of the actuator handle104, the bending elements106a,106bcan continue distally along the arcuate path B1, B2 from an intermediate position within the slots105,107. This process can be repeated until a desired contour angle α2 of the rod10is achieved. A maximum contour angle α2 can be defined by the bending elements106a,106bin the final position, i.e., when the bending element s106a,106bcontact the respective mechanical stops310c,308cof the gear wings310,308which prevent further rotation of the bending elements. In some embodiments, the maximum contour angle α2 can be between about 180° (at an initial position) and about 40° (at a final maximum bend position). A contour angle α2 less than the maximum contour angle can be achieved by driving the bending elements106a,106bto an intermediate position within the slots105,107that is proximal to the distal end105d,107dof the slots, which can correspond to a position prior to contact between the bending elements106a,106band the mechanical stops310c,308c.

Once the desired contour angle α2 is achieved, the rod10can be removed from the implant-receiving channel108, e.g., by moving the rod10away from the front panel102fof the housing, and the bending elements106a,106bcan be moved proximally, e.g., returned to the initial position. As discussed above, in some embodiments, one or both of the bending elements106a,106band/or the support structure110can have one or more retention features (seeFIG.2) that can at least partially retain the rod10within the implant-receiving channel108. In some instances, the one or more retention features can prevent removal of the rod10from the implant-receiving channel108without first moving the bending elements106a,106bproximally to some extent. To this end, the locking pawl112can be released to permit counterrotation of the ratchet wheel302, i.e., rotation of the ratchet wheel302in the second direction R2. The distal end112dof the locking pawl112can be depressed towards the grip portion102bof the housing102. The locking pawl112can pivot about the pivot point119such that the proximal end112pof the locking pawl comes out of engagement with the ratchet wheel302, e.g., as a result of the proximal end112pof the locking pawl moving about the pivot point119and out of contact with the gear tooth of the major gear302aof the ratchet wheel. In some embodiments, the ratchet wheel302can be spring loaded or otherwise biased (e.g., using a coil or torsion spring around any of the various axes of rotation in the gear train) such that dis-engagement from the locking pawl112can cause the ratchet wheel to rotate in a direction opposite the direction of rotation by the driving pawl104p. In other embodiments, one or more of the wings310,308can be spring loaded or otherwise biased to achieve a similar effect. Counterrotation of the ratchet wheel302can drive the gear train300in reverse to move the bending elements106a,106bproximally along the arcuate path B1, B2 in the slots105,107. The bending elements106a,106bcan be driven proximally by the gear train300until the bending elements contact the proximal end105p,107pof the respective slots105,107. At this point, the locking pawl112can be returned to the locking position, i.e., with the proximal end112pof the locking pawl112engaged with the ratchet wheel302to prevent undesired movement of the bending elements.

The devices and methods disclosed herein can be used to bend or contour implants for use in minimally-invasive surgery and/or open surgery. While the devices and methods disclosed herein are generally described in the context of contouring a spinal rod for spinal surgery on a human patient, it will be appreciated that the methods and devices disclosed herein can be used to bend or contour implants for any of a variety of surgical procedures with any human or animal subject, or in non-surgical procedures.

The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present disclosure.

The devices described herein can be processed before use in a surgical procedure. First, a new or used instrument can be obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument can be placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and its contents can then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container can keep the instrument sterile until it is opened in the medical facility. Other forms of sterilization known in the art are also possible. This can include beta or other forms of radiation, ethylene oxide, steam, or a liquid bath (e.g., cold soak). Certain forms of sterilization may be better suited to use with different portions of the device due to the materials utilized, the presence of electrical components, etc.

Although specific embodiments are described above, changes may be made within the spirit and scope of the concepts described. Further features and advantages based on the above-described embodiments are also possible and within the scope of the present disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described. All publications and references cited herein are incorporated by reference in the entirety, except for any definitions, subject matter disclaimers or disavowals, and except to the extent that the incorporated material is inconsistent with the express disclosure herein, in which case the language in this disclosure controls.

Examples of the above-described embodiments can include the following:1. An instrument for bending an implant, comprising:a housing;a handle pivotably coupled to the housing;a gear train coupled to the housing;a first bending element coupled to the gear train;a second bending element coupled to the gear train; andan implant-receiving channel;wherein movement of the handle relative to the housing drives symmetric movement of the first and second bending elements to bend an implant received in the implant-receiving channel.2. The instrument of claim 1, further comprising a support structure coupled to the housing, wherein the implant-receiving channel is defined by the first bending element, the second bending element, and the support structure.3. The instrument of claim 1 or 2, wherein movement of the handle relative to the housing drives symmetric movement of the first and second bending elements from a first position to a second position, the second position defined by a first mechanical stop configured to contact the first bending element and a second mechanical stop configured to contact the second bending element.4. The instrument of any of claims 1 to 3, wherein the first bending element is coupled to a first gear of the gear train and the second bending element is coupled to a second gear of the gear train.5. The instrument of claim 4, wherein at least one of the first gear and the second gear includes a mechanical stop; and wherein movement of the handle relative to the housing is configured to bring at least one of the first bending element and the second bending element into contact with the mechanical stop.6. The instrument of any of claims 1 to 5, wherein movement of the handle relative to the housing drives symmetric movement of the first and second bending elements along an arcuate path.7. The instrument of any of claims 1 to 6, wherein movement of the handle relative to the housing drives the first bending element in a clockwise direction and the second bending element in a counterclockwise direction.8. The instrument of any of claims 1 to 7, wherein a first end of the handle is pivotably coupled to the housing.9. The instrument of claim 8, wherein the implant-receiving channel is perpendicular to a longitudinal axis of the housing.10. The instrument of claim 8 or 9, wherein movement of the handle relative to the housing drives symmetric movement of the first and second bending elements from a first position to a second position, the second position located distal to the first position.11. The instrument of any of claims 1 to 10, wherein the gear train includes at least two compound gears.12. The instrument of any of claims 1 to 11, wherein the gear train provides a mechanical advantage greater than about 15.13. An instrument for bending an implant, comprising:a housing;a gear train coupled to the housing, the gear train having a first compound gear, a second compound gear, and at least one gear wing;at least one bending element coupled to the at least one gear wing;a handle coupled to the housing to drive the gear train; andan implant-receiving channel configured to receive an implant to be bent by the at least one bending element against one or more support elements.14. The instrument of claim 13, wherein the gear train includes a ratchet wheel engaged with the first compound gear; and wherein movement of the handle causes rotation of the ratchet wheel, thereby driving rotation of the first compound gear and the second compound gear.15. The instrument of claim 14, wherein the ratchet wheel is a compound gear.16. The instrument of claim 14 or 15, wherein the handle includes a driving pawl engaged with the ratchet wheel.17. The instrument of claim 16, further comprising a locking pawl engaged with the ratchet wheel, the locking pawl located remote of the driving pawl.18. The instrument of any of claims 13 to 17, wherein the first compound gear is engaged with the second compound gear and the at least one gear wing.19. The instrument of claim 18, wherein a major gear of the first compound gear is engaged with the second compound gear and a minor gear of the first compound gear is engaged with the at least one gear wing.20. The instrument of any of claims 13 to 19, wherein movement of the handle drives the gear train to move the at least one bending element.21. The instrument of any of claims 13 to 20, wherein the at least one gear wing includes a first gear wing and a second gear wing, and the at least one bending element includes a first bending element coupled to the first gear wing and a second bending element coupled to the second gear wing.22. The instrument of claim 21, wherein the first gear wing is engaged with the second compound gear and the second gear wing is engaged with the first compound gear.23. The instrument of any of claims 13 to 22, wherein the gear train provides a mechanical advantage greater than about 15.24. A method, comprising:placing an implant in an implant-receiving channel of an implant bending instrument;driving a compound gear train to symmetrically move a plurality of bending elements to intersect the implant-receiving channel and bend the implant received therein.25. The method of claim 24, wherein driving the compound gear includes actuating a single handle to rotate a first compound gear of the compound gear train.26. The method of claim 25, further comprising releasing the handle while the bending elements remain stationary.27. The method of any of claims 24 to 26, further comprising releasing a locking pawl to drive the compound gear train in reverse and move the plurality of bending elements away from the implant-receiving channel.