Tensioning instruments

Tensioner instruments, systems, and methods of tensioning flexible bands in-situ. The tensioner instrument may include first and second pivoting arms with a base for pinching and pulling the flexible band to provide tension. The tensioner instrument system may include a clip inserter and a ratcheting tensioner for tensioning the band through an implant. The instruments may be configured to apply and maintain tension to the flexible band, thereby providing the desired correction to the spine.

FIELD OF THE INVENTION

The present application relates generally to surgical instruments, and more particularly, tensioning instruments, for example, for spine surgery.

BACKGROUND OF THE INVENTION

Many types of spinal irregularities cause pain, limit range of motion, or injure the nervous system within the spinal column. These irregularities may result from, without limitations, trauma, tumor, disc degeneration, and disease. Often, these irregularities are treated by immobilizing a portion of the spine. This treatment typically involves affixing screws, hooks and/or clamps to one or more vertebrae and connecting the screws, hooks and/or clamps to an elongate spinal rod that stabilizes members of the spine.

Flexible bands may be used to achieve correction and provide fixation as an alternative and/or supplement to pedicle screws during spinal deformity surgery. The bands may be wrapped around bony anatomy and then a force may be applied to secure the spine to the spinal rod. Correction of the spinal deformity may be achieved and held by application of tension to the flexible band. There exists a need for improved tensioning instruments configured to apply tension to the bands.

SUMMARY OF THE INVENTION

To meet this and other needs, instruments, systems, and methods of tensioning flexible bands in-situ are provided. After a flexible band is wrapped around bony anatomy, such as a lamina or transverse process, the instruments may be configured to apply and maintain tension to the flexible bands, thereby providing the desired correction to the spine.

According to one embodiment, a tensioner instrument for tensioning a band may include first and second pivoting arms and a base. The first and second pivoting arms may each extend from a proximal end to a distal end. The first and second pivoting arms may each include handles near the proximal ends. The base may have a generally L-shaped body coupled to the first and second pivoting arms. The base may define a slot to retain the band and/or guide the distal end of the first pivoting arm. The second pivoting arm may define an opening located beneath the slot and sized and dimensioned to receive the band. When the handles are compressed together, the band may be pinched in the slot between the distal end of the first pivoting arm and the base, and a distance between the distal ends of the arms is increased, thereby applying a tension to the band. A ratchet may be positioned between the proximal ends of the first and second pivoting arms, thereby allowing for incremental tensioning.

The tensioner instrument may include one or more of the following features. The base may include a first elongate portion and a second elongate portion angled relative to the first elongate portion at a corner. The corner of the first and second elongate portions may couple with the first pivoting arm at a first hinge. The second elongate portion of the base may terminate at a free end, which couples with the second pivoting arm at a second hinge. The first hinge may move the first pivoting arm towards the base and the second hinge may move the base away from the second pivoting arm. The first end of the ratchet may be coupled to one of the first and second pivoting arms via a pivot pin and the opposite end of the ratchet may be positionable through a slot in the other of the first and second pivoting arms. The ratchet may be a linear ratchet having a plurality of teeth along an interior of the ratchet. A pawl in the slot may be configured to engage the teeth to thereby incrementally maintain the position of the first and second pivoting arms and the amount of tension applied to the band.

According to one embodiment, a tensioner instrument may include a clip inserter and a ratcheting tensioner. The clip inserter may include a cannulated main body extending from a proximal end to a distal tip, a collar configured to translate along the main body, and a threaded shaft configured to move the collar. The ratcheting tensioner may include a fixed handle coupled to the clip inserter, a pivoting handle coupled to the fixed handle, a ratchet assembly including a pair of rotary ratchets and a spool keyed to the ratchets and positioned between the ratchets, and an actuator assembly including an actuator configured to engage the first and second rotary ratchets. When the pivoting handle is squeezed toward the fixed handle, the actuator may contact the ratchets and forces the ratchets and spool to rotate.

The tensioner instrument may include one or more of the following features. The collar may be a ring with two arms extending toward the distal tip of the main body. Each of the arms may define a notch configured to secure a spinal rod when the collar moves distally. The threaded shaft may define a hollow body such that a driver shaft is passable through the threaded shaft. The main body of the clip inserter may include a wire cut and one or more grooves on opposite sides of the wire cut configured to engage with pins on the collar. The actuator assembly may be positioned in the pivoting handle and include an actuator button for engaging and disengaging the actuator, an actuator pin for securing the actuator, and an actuator spring causing the actuator to contact the ratchets. The ratcheting tensioner may include a release assembly including a release arm pivotably coupled to the fixed handle with a pin and a release spring forcing the release arm into contact with the ratchets at rest. The release arm may include a body with a thumb press and a pair of spaced apart tongues for engaging the ratchets. The ratcheting tensioner may include a button assembly for securing the clip inserter to the ratcheting tensioner, the button assembly including a button, a button pin for securing the button, a stop pin for engaging with the body of the clip inserter, and a button spring causing the stop pin to protrude.

According to another embodiment, a system for tensioning a spinal system may include a flexible band configured to loop around a bone, a spinal rod configured for stabilizing two vertebrae, a band clamp implant having a recess for retaining the spinal rod and an opening for receiving the flexible band, and a tensioner instrument including a clip inserter and a ratcheting tensioner configured for tensioning the flexible band. The clip inserter may include a cannulated body and a collar configured to translate along the body and engage the spinal rod in a downward position. The ratcheting tensioner may include a fixed handle coupled to the clip inserter, a pivoting handle coupled to the fixed handle, a ratchet assembly including a ratchet and a spool keyed to the ratchet, and an actuator configured to engage the ratchet. When the pivoting and fixed handles are squeezed together, the actuator may force the ratchet and spool to rotate, thereby applying tension to the flexible band.

According to yet another embodiment, a method for tensioning a spinal system, in situ, may include one or more of the following steps in any suitable order: (1) looping a flexible band around a portion of bone, such as a lamina or transverse process; (2) threading the band through an implant; (3) affixing the implant to the clip inserter; (4) positioning the implant against a spinal rod and securing the clip inserter to the spinal rod; (5) threading the band through the spool; (6) positioning the tensioner against the implant; (7) squeezing the handles of the tensioner together causing the spool to rotate and wrapping the band around the spool, thereby applying controlled, incremental tension to the band; (8) once the desired tension has been reached, securing the band in the implant (e.g., with a set screw); and (9) removing the instrument from the patient.

Also provided are kits including implants of varying types and sizes, rods, tensioner instruments of varying types and configurations, insertion tools, and other components for performing the procedure.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the disclosure are generally directed to instrument, systems, and methods for tensioning flexible bands in-situ. Specifically, embodiments are directed to instruments and systems configured to tension a flexible band in order to provide fixation to the spine.

Additional aspects, advantages and/or other features of example embodiments of the invention will become apparent in view of the following detailed description. It should be apparent to those skilled in the art that the described embodiments provided herein are merely exemplary and illustrative and not limiting. Numerous embodiments of modifications thereof are contemplated as falling within the scope of this disclosure and equivalents thereto.

Referring now toFIGS.1-7, a handled tensioner instrument10is shown according to one embodiment. The tensioner10is configured to apply tension to an elongate member, cable, tether, cord, or band12. The band12may be a flexible member configured to be wrapped around bony anatomy or a portion of the spine, such as the lamina or transverse process, for example. Although described with reference to the spine, it will be appreciated that the instruments and systems described herein may be applied to other orthopedic locations and applications, such as trauma.

The flexible band12may be able to adapt to complex anatomies, such as severe spinal deformities. The band12may be used alone or in conjunction with an implant14, such as a screw (e.g., a pedicle screw), a clamp, a hook, or other suitable implant. The implant14may engage with an elongate member, such as a spinal rod, to provide fixation between vertebrae. In this embodiment, the implant14is shown as a pedicle screw with a tulip for receiving a spinal rod and a clamp for retaining the band12. Examples of other implants and rod constructs are described in more detail, for example, in U.S. Pat. Nos. 9,433,441; 10,034,692; 10,548,644; and 10,575,879, which are incorporated by reference herein in their entireties for all purposes. After the implant14is affixed to bone and/or secured to bone by looping the band12around the bony anatomy, correction of the spinal deformity may be achieved and held by the application of tension to the flexible band12.

The band12may be comprised of polyethylene terephthalates (PET), polyethylenes (e.g., ultrahigh molecular weight polyethylene or UHMWPE), polypropylenes, silk, polyamides, polyesters, polyacrylonitriles, silk cottons, combinations thereof, or other suitable biocompatible materials. The band12may be generally round, oval, or flat/tape geometry. The band12may transition from one geometry to another (e.g., a round to flat geometry or vice versa). If desired, the band12may be fully radiolucent or may have one or more marker strands that are designed to show up on fluoroscopy.

With emphasis onFIG.1, the tensioner10pinches and pulls the flexible band12in order to provide tension. The tensioner10includes an upper handle arm or first pivoting arm20, a lower handle arm or second pivoting arm22, and a base24. The first pivoting arm20extends from a first end or distal end26to a second end or proximal end28. Similarly, the second pivoting arm22extends from a distal end30to a proximal end32. The base24and distal ends26,30form the tip of the instrument10, which is configured to access the patient in-situ. The proximal ends28,32are manipulable by a user, such as a surgeon. The first and second pivoting arms20,22may each define a handle60,62, for example, near the proximal ends28,32, which are configured to be gripped and squeezed by the user. The inner facing portions of the handles60,62may include curved leaf springs64,66configured to apply an opposing force to the handles60,62when squeezed.

As best seen inFIGS.6and7, the base24may have a generally L-shaped body. For example, the base24may have a first elongate portion34and a second elongate portion36angled relative to the first elongate portion34. A distal portion or first end38of the first elongate portion34of the base24may define a channel or slot40configured to retain the band12and/or guide the distal end26of the first arm20. The second end42of the first elongate portion34of the base24integrally connects to the second elongate portion36. The corner or second end42of the first elongate portion34of the base24may mate with the first arm20. The second elongate portion36of the base24terminates at a proximal end or free end44, which may be configured to mate with the second arm22.

As shown inFIGS.2and3, the instrument10may include a ratchet52positionable between the proximal ends28,32of the upper and lower pivoting arms20,22to hold tension applied to the flexible band12. The ratchet52may include a linear body or rail with a plurality teeth54defined along the interior of the ratchet52. A first end of the ratchet52may be coupled to one of the pivot arms20,22via a pivot pin56and the opposite end of the ratchet52may be positionable through a slot or opening58in the body of the other pivot arm20,22. InFIG.2, the tensioner10is shown in a first relaxed position where tension would not be applied to the band12. InFIG.3, the tensioner10is shown in a second tensioned position where tension would be applied to the band12. As the ratchet52moves through the opening58, a pawl in the opening58engages the teeth54to thereby incrementally maintain the position of the arms20,22and the amount of tension applied to the band12.

With emphasis onFIGS.4and5, the base24may be fixed to each pivoting arm20,22to create two hinges46,48. The first hinge46connects the base24to the first arm20, for example, at the corner42connecting the first and second elongate portions34,36of the base24. The second hinge48connects the base24to the second arm22, for example, at the free end44of the second elongate portion36of the base24. The hinges46,48may each include a pivot pin. Although pivot pins are exemplified in this embodiment, it will be appreciated that other suitable joints could be selected.

The first hinge46moves the upper pivoting arm20toward the base24, while the second hinge48moves the base24away from the lower pivoting arm22. The distal end26of the upper pivoting arm20may include geometry configured to move within the slot40in the base26. In the rest/relaxed position shown inFIG.4, there is clearance between the distal end26of the upper pivoting arm20and the base26(slot40). When the handles60,62are squeezed into the tensioned position as shown inFIG.5, the upper pivoting arm20moves toward the base24, decreasing the clearance between the upper pivoting arm20and the base26until the upper pivoting arm20contacts the base24and travels along slot40. In this manner, the band12residing in slot40is pinched between the distal end26of the arm20and the base24.

As best seen inFIG.3, the lower pivoting arm22has a thru hole50configured to accept the flexible band12. The thru hole50is located directly beneath the slot40in the base26, thus allowing the flexible band12to be passed through the hole50in the lower pivoting arm22and into the slot40in the base26. When the handles60,62are squeezed, the upper pivoting arm20pinches the flexible band12against the base26and the lower pivoting arm22pushes the contacting surface away from the base26, thus providing tension to the flexible band12.

As seen inFIGS.6and7, the lower pivoting arm22may be placed against the implant14in order to tension the flexible band12through the implant14. As the handles60,62are compressed, the distance between the distal ends26,30of the arms20,22is increased, and a tension is applied to the band12. The ratchet52between the upper and lower pivoting arms20,22holds and maintains the tension applied to the band12.

During the procedure, the implant14may be secured to bone. In this embodiment, the implant14includes a pedicle screw with a tulip for receiving a spinal rod and an attached clamp for receiving the band12. It will be appreciated that other suitable implants may be selected. The band12may be threaded through the tensioner12and the implant14. The band12may be looped around a portion of bone, such as the lamina. A tension may be applied to the band12by squeezing the handles60,62of the tensioner12toward one another. The ratchet52allows for controlled, incremental tensioning of the band12. Once the desired tension has been reached, the band14may be secured by the implant12(e.g., with a set screw in the clamp), and the instrument10may be removed from the patient.

Turning now toFIGS.8-23, an embodiment of a tensioner instrument system100is shown. The tensioner system100includes a clip inserter102and a ratcheting tensioner104, which are configured to mate together and apply tension to the band12. Although the tensioner system100is described with respect to two separate components, it will be appreciated that the instrument100may comprise a single integral body. The tensioner system100is configured to insert an implant106onto a spinal rod108and tension the flexible band12through the implant106.

As best seen inFIG.10, the implant106may be a band clamp implant having a generally c-shaped body with a recess110for retaining the rod108, one or more openings112for receiving the band12, and a locking member or set screw114for retaining the band12in the implant106and maintaining tension applied to the band12. Although the band clamp implant106is exemplified in this embodiment, it will be appreciated that the tensioner system100is configured to interface with other implants and apply tension to the band12. Examples of additional implants and rod constructs are described in more detail, for example, in U.S. Pat. Nos. 9,433,441; 10,034,692; 10,548,644; and 10,575,879, which are incorporated by reference herein in their entireties for all purposes.

Turning now toFIGS.9-15, the clip inserter102includes a main body120, a collar122, and a threaded shaft124extending through the main body120. With emphasis onFIG.9, the clip inserter102has a main body120extending from a tip or distal end126to a proximal end128. The main body120may be in the form of a hollow outer tube or cannula defining a central channel118between its distal and proximal ends126,128. The body120defines a recess130at the distal tip126which is configured to accept the band clamp implant106. The recess130may define one or more protrusions132configured to engage with a corresponding mating groove on the band clamp implant106.

As shown inFIG.10, the implant106is receivable in the recess130and mates with the protrusions132such that the implant106is retained at the distal end126of the main body120of the clip inserter102. It will be appreciated that the implant106may be coupled to the tip126of the clip inserter102in any suitable manner. As shown inFIG.13, a bottom surface of the main body120toward its distal end126may include a wire cut132. The wire cut132may extend along a longitudinal axis of the body120from the distal end126inward a distance past the collar122of the clip inserter102. The wire cut132allows the clip inserter102to splay open to accept and release the implant106.

The clip inserter instrument102has a collar122that is able to translate up and down the instrument102to engage and disengage with the spinal rod108. In the upward position, the collar122is disengaged from the rod108. In the downward position, the collar122is engaged with the rod108. The collar122may be a ring with a hollow center such that the main body120is received through the collar122. Toward the distal end126of the body120, the collar122may include one or more notches134configured to engage the spinal rod108when the collar122is in the downward position (as shown inFIG.12). The collar122may include a pair of spaced apart arms136which define the notches134at the free ends of the arms136. When the collar122moves distally, the notches134engage with the outer surface of the rod108, thereby securing the rod108to the clip inserter102.

The collar122is able to translate up and down the instrument102via engagement with the threaded shaft124. The threaded shaft124is receivable through the channel118in the main body120. The threaded shaft124may define a hollow body such that a driver shaft138is passable through the center of the threaded shaft124. The threaded shaft124includes a threaded portion140along the length of the shaft124. The threaded portion140may have one or more threads of suitable diameter, handedness, thread form, thread angle, lead, pitch, etc. The threaded shaft124and collar122may cooperate as a ball screw, leadscrew, or other suitable translation mechanism. The proximal end of the shaft124may include a handle interface142(e.g., a ribbed portion) configured to mate with a handle (not shown). When the threaded shaft124is rotated, the collar122is translated upward to the disengaged position or downward to the engagement position with the rod108.

The threaded shaft124may be rotated in a first direction to translate the collar122downward. Actuation of the threaded shaft124pushes the collar122into contact with the spinal rod108, which is contacted on the underside by the band clamp implant106. These contact forces allow the band clamp implant106to be rigidly held in place on the spinal rod108. The threaded shaft124is cannulated to accept the driver shaft138, which is configured for tightening the set screw114on the band clamp106. The driver shaft138may also include a handle interface configured to mate with a handle (not shown).

As visible inFIG.13, the main body120of the clip inserter102may include one or more grooves144configured to engage with pins146on the collar122. In particular, a pair of angled grooves144may be positioned on either side of the central wire cut132. The grooves144in the main body120may be angled inward toward the proximal end128and outward toward the distal end126. The angled grooves144allow the pins146in the collar122to force the distal end126of the body120to splay open when the collar122is pulled into the upward position, thereby releasing the implant106from the clip inserter102.

With emphasis onFIGS.14and15, the clip inserter102may include a button150which is positioned within a slot152within the main body120. An inner portion of the button150may define a clearance hole156and threads154configured to engage the threaded shaft124. The button150may be held in place by a pin and contacts one or more springs158. In the rest position shown inFIG.14, the threads154inside the button150engage the threaded portion140of the threaded shaft124. When the button150is depressed as shown inFIG.15, the clearance hole156allows the threaded shaft124to translate freely through the button150.

Turning now toFIGS.16-23, the tensioner system100includes a ratcheting tensioner104. The ratcheting tensioner104is a handled instrument which uses a ratchet assembly220to rotate a spool222in order to wind up the band12, thereby providing tension to the band12. An exploded view of the ratcheting tensioner104is shown inFIG.18. The ratcheting tensioner104may include a fixed handle170, a pivoting handle172, and a ratchet assembly220with an actuator assembly240and a release assembly254.

With emphasis onFIG.16, the ratcheting tensioner104has a fixed handle170and a pivoting handle172. The fixed handle170extends from a distal end174, which is configured to couple to the clip inserter102, to a proximal end176. The proximal end176includes a handle portion178configured to be manipulated by the user. A neck180connects the distal portion174to the handle portion178. The neck180may be bent or angled upwards to provide a pistol grip orientation for the ratcheting tensioner104when assembled to the clip inserter102and used to tension the band12. For example, the neck180may be curved back toward the fixed handle170. The distal portion174of the fixed handle170may define an opening or through slot182configured to receive the main body120of the clip inserter102. The distal portion174may include a ring or loop184defining the slot182for retaining the clip inserter102. For example, the body120of the clip inserter102may be inserted through the slot182in the fixed handle170near the proximal end128of the clip inserter102.

As shown inFIGS.17and18, the ratcheting tensioner104may be coupled to the clip inserter102with a button assembly190. The button assembly190may include a button192, a button pin194for securing the button192, a stop pin196for engaging with the body120of the clip inserter102, and a button spring198causing the stop pin196to protrude into the slot182. Intersecting the slot182is a bore202sized and dimensioned to accept the button spring198and the stop pin196. At rest, the button spring198causes the stop pin196to protrude into the slot182which accepts the clip inserter102. The fixed handle170has a first through hole204sized and dimensioned to accept the button192and a second transverse through hole206configured to accept the button pin194. The button192is coupled to the stop pin196with the button pin194such that the stop pin196translates back into the fixed handle170when the button192is depressed. When the button192is depressed as shown inFIG.20, the stop pin196retracts and the fixed handle170may be engaged onto the clip inserter102. When the button192is released as shown inFIG.21, the stop pin196translates and extends outwardly into a mating hole208on the clip inserter102to securely couple the ratcheting tensioner104to the clip inserter102.

The pivotable handle172extends from a distal end210, which couples to the fixed handle170, to a proximal end212. The proximal end212includes a handle portion214configured to be manipulated by the user. The distal end210is pivotably coupled to the fixed handle170with a ratchet assembly220. The pivotable handle172and fixed handle170are sized and dimensioned to retain the ratchet assembly220.

The ratchet assembly220includes a spool222and at least one rotary ratchet224. For example, the assembly220may include first and second rotary ratchets224positionable on opposite sides of the spool222. The spool222includes two half rounds or halves232with a space or gap230separating the two halves232. The outer surfaces of the halves232may be curved or rounded. Each rotary ratchet224may include a round gear having a plurality of teeth234around the perimeter of the ratchet224. The teeth234may be uniformly distributed around the body of the ratchet224. The actuator242is configured to engage the teeth234as the ratchets224rotate. The teeth234may be sloped or angled to allow the actuator242to slide up and over the teeth234and into the depression between teeth234when the ratchets224rotate in a first direction. When the ratchets224try to move in an opposite direction, the actuator242catches against the first tooth234, thereby locking the actuator242against the tooth234and preventing any further motion in that direction. The ratchet assembly220is secured to the handles170,172with first and second cap plates236positioned on the outer sides of the ratchets224. A plurality of fasteners238, such as set screws, may be used to secure the cap plates236and the entire assembly.

Each handle170,172has a thru hole226sized and dimensioned to accept the spool222. The two ratchets224sit between the pivoting handle172and the fixed handle170on either side of the fixed handle170. Each ratchet224defines two cutouts228configured to accept the two halves of the spool222. The spool222is able to rotate independently of the handles170,172, but the spool222is keyed to the ratchet224such that the spool222rotates when the ratchet224rotates. The space or gap230between the two halves of the spool222is large enough to accept the flexible band12.

The actuator assembly240includes an actuator242for engaging with the ratchets224, an actuator button244for engaging and disengaging the actuator242, an actuator pin246for securing the actuator242, and an actuator spring248causing the actuator242to contact the ratchets224. The actuator242includes a body with two spaced apart pawls250. Each pawl250is configured to engage with teeth234on the respective ratchets224. The pivoting handle172has a bore to accept the actuator242and actuator spring248. The actuator spring248forces the actuator242to contact the ratchets224in the resting position. The pivoting handle172has two transverse thru holes to accept the actuator button244and the actuator button pin246. The actuator button244is coupled to the actuator242with the actuator pin246such that when the button244is depressed, the actuator242translates away from the ratchets224, thereby disengaging the actuator242from the ratchets224.

The release assembly254includes a release arm256, a release spring258, and a release pin260for pivotably securing the release arm256. The release arm256include a body with a thumb press262and a pair of spaced apart tongues264for engaging the ratchets224. The release arm256is pivotably coupled to the fixed handle170. The release arm256is positioned within a slot and is secured by pivot pin260. The release arm256defines a counter bore to accept the release spring258. The release spring258forces the tongues264of the release arm256into contact with the ratchets224at rest. The tongues264of the release arm256may be disengaged from the ratchets224by depressing the release arm256, thereby compressing the release spring258and pivoting the tongues264out of contact with the ratchets224.

The ratcheting tensioner104may include a pair of leaf springs266coupled to the handles170,172with one or more fasteners268, such as a plurality of set screws. The curved leaf springs266cause the handles170,172to remain open at rest. When the handles170,172are squeezed together, the actuator242on the pivoting handle172contacts the ratchets224and forces the ratchets224and spool222to rotate. While the ratchet224is rotating, the release arm256on the fixed handle170is lifted into consecutive ratchet positions. When the handles170,172are released, the leaf springs266cause the handles170,172to open and the actuator242on the pivoting handle172lifts back into consecutive ratchet positions. The spool222is held in the new orientation and does not rotate back with the opening pivoting handle172because the release arm256on the fixed handle170is engaged with the ratchet224. This process is repeated causing the spool222to rotate within the ratcheting tensioner104, thereby applying tension to the band12.

As shown inFIGS.22-23, the ratcheting tensioner104is engaged with the clip inserter102with button assembly190. The flexible band12is fed thru the band clamp implant106and the band clamp106is placed onto the rod108with the collar122of the clip inserter102. The flexible band12is fed between the two halves232of the spool222of the ratcheting assembly220. The handles170,172of the ratcheting tensioner104are then actuated to wrap the flexible band12around the spool222, thereby pulling the flexible band12thru the band clamp106and applying tension. Once a sufficient amount of tension is achieved, the driver shaft138may be passed though the clip inserter102into the set screw114on the band clamp106to lock the tension in the band12. Tension may be removed from the flexible band12by unwinding the spool222. In order to do this, the release arm256and actuator button244are depressed to disengage the ratchets224and the spool222is rotated manually to unwind the spool222.

During the procedure, the band12may be threaded through the implant106and through the gap230in the spool222of the ratcheting tensioner104. The band12may be looped around a portion of bone, such as the lamina or transverse process. Tension may be applied to the band12by squeezing the handles170,172of the ratcheting tensioner104. As the spool222rotates, the band12wraps around the spool222applying controlled, incremental tension to the band12. Once the desired tension has been reached, the band14may be secured by the implant106(e.g., with a set screw114in the clamp106), and the instrument100may be removed from the patient.

Turning now toFIGS.24and25, an alternative version of a tensioner instrument system300is shown, which is the same as tensioner100, except with a different overhead style grip configuration. Similar to the pistol grip style tensioner system100, the overhead style tensioner system300includes the clip inserter102and ratcheting tensioner104. In tensioner system300, however, the ratcheting tensioner104is configured to be placed in an overhead orientation with respect to the clip inserter102. For the overhead system300, the ratcheting tensioner104is configured to be placed in the overhead orientation because the neck302of the fixed handle170is angled opposite of neck180. For example, the neck302of tensioner system300is angled or curved back toward the pivoting handle172.

As shown inFIG.25, the overhead style tensioner system300offers the surgeon another option depending on their preference of hand position during tensioning of the flexible band12. If desired, the overhead style tensioner system300may be used in conjunction with the pistol grip style tensioner100. Band clamps106may be used at sequential spinal levels in order to reduce a deformity and anatomy may dictate that the band clamps106are positioned within close proximity to one another. Therefore, it may be advantageous to offer both styles of ratcheting tensioner100,300in order to give space for the surgeon's hands.

The systems described herein allow surgeons to tension the flexible band in order to correct spinal deformities and achieve fixation. The instruments offer easy engagement with the band clamps and flexible bands, which may save time, for example, compared to instruments that use secondary locking steps for the band clamps or flexible bands. The tensioning instruments allow for essentially limitless tensioning capacity, which may be an improvement over instruments limited by the travel range of threaded mechanisms, for example. The tensioners may save the surgeon time during surgery as the tensioner does not need to be reset during correction. In addition, the handle mechanisms may allow for ease of use without the need for additional actuating instruments. The variety of configurations may also allow the surgeon to customize the implementation of instruments to the patient in order to optimize visualization of the surgical site.

Although the invention has been described in detail and with reference to specific embodiments, it will be apparent to one skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention. Thus, it is intended that the invention covers the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents. It is expressly intended, for example, that all components of the various devices disclosed above may be combined or modified in any suitable configuration.