Patent Description:
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.

In addition, instability of the first and second cervical vertebrae is a common pathology caused by traumatic injury. While posterior fixation of the cervical spine is most commonly performed using screw fixation, there are times when it is advantageous to perform posterior cervical fixation using non-screw based techniques, including patients with low bone mineral density or fractured anatomy. In these cases, flexible bands may be used to achieve correction and provide fixation. The bands are wrapped around bony anatomy and then tensioned to provide fixation and promote healing. The same technique is commonly used with metal wires at C1-C2. However, metal wires have the potential to wear through bone or loosen over time leading to neurological injury.

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 translate 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 tensioners for tensioning the flexible band for securing the flexible band to the bone.

<CIT> discloses a system known in the art.

According to the invention it is provided a system for applying tension to a flexible band during a spinal fixation surgery according to independent claim <NUM>. Further advantageous embodiments of the invention are set forth in the dependent claims Associated surgical methods are also described herein to aid understanding the invention.

According to some examples of the concepts described herein, a system for applying tension to a band clamp during a spinal fixation surgery, the system including a first handle assembly, a second handle assembly able to move relative to the first handle assembly, a spool assembly disposed between the first handle assembly and the second handle assembly, the spool assembly able to receive a flexible band used for fixating a rod to a spine of a patient, and an adjustable head movably fixated to the first handle assembly. The adjustable head is able to be angled to the first handle assembly in a first orientation and angled differently in a second orientation.

According to other examples of the concepts described herein, a system for fixating a rod to a spine during surgery, the system includes a band clamp, a band clamp inserter able to fixate the band clamp to the rod, a flexible band able to be inserted into the band clamp, and a tensioner able to apply tension to the flexible band prior to fixating the flexible band in the band clamp. The tensioner includes a first handle assembly, a second handle assembly able to move relative to the first handle assembly, a spool assembly disposed between the first handle assembly and the second handle assembly, the spool assembly able to receive a flexible band used for fixating a rod to a spine of a patient, and an adjustable head movably fixated to the first handle assembly. The adjustable head is able to be angled to the first handle assembly in a first orientation and angled differently in a second orientation.

Also described, but not claimed, are kits including implants of varying types and sizes, rods, tensioner instruments, insertion tools, and other components for performing the procedure.

A more complete understanding of the present disclosure, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, wherein: the invention is shown in particular in <FIG> the remaining Figures being resented for a better understanding of the invention.

The term "embodiment" used in the present specification does not necessarily indicate ways of carrying out the invention claimed but also examples which aid understanding the invention.

Embodiments of the disclosure are generally directed to implants, systems for securing the flexible band to bone. Specifically, embodiments are directed to implants and systems configured to achieve correction and provide fixation as an alternative and/or supplement to pedicle screws during spinal deformity surgery.

Additional advantages and/or other features of example embodiments of the disclosure 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 to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. The implant system <NUM> is configured to secure an elongate member, cable, tether, cord, or band <NUM> to a spinal rod <NUM>. The band <NUM> may 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. The implant assembly <NUM> may engage with an elongate member, such as a spinal rod <NUM>, to provide fixation between vertebrae. The flexible band <NUM> may be used as the primary fixation point at a particular spinal level when the placement of pedicle screws is difficult or impossible. Alternatively, the flexible band <NUM> may be used in conjunction with pedicle screws at a particular level to provide additional fixation. Although described with reference to the spine, it will be appreciated that the implants and systems described herein may be applied to other orthopedic locations and applications, such as trauma.

The flexible band <NUM> may be able to adapt to complex anatomies, such as severe spinal deformities. The assembly <NUM> allows the surgeon to achieve correction and fixation of a spinal deformity by securing the flexible band <NUM> to the spinal rod <NUM>. This technique may be advantageous in pediatric and neuromuscular deformity cases when traditional pedicle screw fixation is compromised or not possible due to the presence of weak bone or dysmorphic vertebrae. Before or after the implant assembly <NUM> is affixed to bone and/or secured to bone by looping the band <NUM> around the bony anatomy, correction of the spinal deformity may be achieved and held by the application of tension to the flexible band <NUM>.

The band <NUM> may 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 band <NUM> may be generally round, oval, or flat/tape geometry. The band <NUM> may transition from one geometry to another (e.g., a round to flat geometry or vice versa). If desired, the band <NUM> may be fully radiolucent or may have one or more marker strands that are designed to show up on fluoroscopy.

With emphasis on <FIG>, the implant assembly <NUM> includes a band clamp implant <NUM> capable of securing the flexible band <NUM> to the spinal rod <NUM>. The band clamp implant <NUM> has a main body <NUM> including an upper surface <NUM>, a lower surface <NUM>, first and second opposed side surfaces <NUM>, <NUM>, a nose or front surface <NUM>, and a back or rear surface <NUM>. For example, the upper surface <NUM> and side surfaces <NUM>, <NUM> may be generally flat or planar and the lower and back surfaces <NUM>, <NUM> may be generally rounded or convex.

As shown in <FIG>, the band clamp implant <NUM> includes a main body <NUM>, a first locking member <NUM> configured to secure the rod <NUM>, and a second locking member <NUM> with a saddle <NUM> configured to secure the band <NUM>. With emphasis on <FIG>, the main body <NUM> of the clamp <NUM> defines a first opening, recess, or rod slot <NUM> sized and dimensioned to accept the spinal rod <NUM> and a separate second opening or band slot <NUM> configured to accept the flexible band <NUM>. The rod slot <NUM> may be recessed into the front surface <NUM> of the implant <NUM> and may define a generally c-shaped recess sized and dimensioned to receive the rod <NUM>. The band slot <NUM> may extend from the lower surface <NUM> to the rear surface <NUM> of the implant <NUM>. The band slot <NUM> may be stepped such that a first portion rises up from the lower surface <NUM> and a second portion runs over to the back surface <NUM>. The band slot <NUM> is located beneath the rod slot <NUM> and is oriented perpendicular to a long axis A of the spinal rod <NUM>.

The main body <NUM> has a first hole <NUM> in fluid communication with the rod slot <NUM>. The first hole <NUM> may include a threaded portion <NUM> around an inner periphery of the hole <NUM>. The first locking member <NUM> is positionable within the first hole <NUM>, and when in a downward position, a bottom surface of the locking member <NUM> is configured to contact and secure the spinal rod <NUM> within the main body <NUM> of the implant <NUM>. The first locking member <NUM> may include a threaded portion <NUM> around an outer surface, which is configured to threadedly mate with the first hole <NUM>. The first locking member <NUM> may define an instrument recess <NUM> in an upper surface of the first locking member <NUM> configured to be engaged by an instrument, such as a driver, for rotating the locking member <NUM> into the locked position.

The main body <NUM> has a second hole <NUM> in fluid communication with the band slot <NUM>. The hole axis of the second hole <NUM> may be generally parallel to the hole axis of the first hole <NUM>. The second hole <NUM> may include a threaded portion <NUM> around an inner periphery of the hole <NUM>. As shown in <FIG>, the second locking member <NUM> may be positioned within the second hole <NUM> to secure the flexible band <NUM> within the band slot <NUM>. The second locking member <NUM> may include a fastener or set screw <NUM> and a saddle <NUM>. The set screw <NUM> and saddle <NUM> may be attachable to one another. The set screw <NUM> is able rotate independently of the saddle <NUM>. The saddle <NUM> may define a ring or cylindrical body, and an upper surface of the saddle <NUM> may include one or more tabs or prongs <NUM> extending upwardly and/or outwardly. The prongs <NUM> may mate with a corresponding recess or groove within the lower surface of the set screw <NUM> to thereby connect the saddle <NUM> to the set screw <NUM>. The prongs <NUM> on the saddle <NUM> may flex inward when pressed into the set screw <NUM> and snap back to its original shape when it reaches the groove in the set screw <NUM>. The set screw <NUM> may include a threaded portion <NUM> around an outer surface, which is configured to threadedly mate with the second hole <NUM>. The set screw <NUM> may define an instrument recess <NUM> in an upper surface configured to be engaged by an instrument, such as a driver, for rotating the set screw <NUM> and moving the locking member <NUM> into the locked position.

When the second locking member <NUM> is in a downward position, a bottom surface of the saddle <NUM> is configured to contact and secure the band <NUM> within the main body <NUM> of the implant <NUM>. The set screw <NUM> and saddle <NUM> are able to travel up and down within the second threaded hole <NUM>. The travel of the set screw <NUM> is such that the saddle <NUM> may reversibly interfere with the band slot <NUM>. In a downward position, the saddle <NUM> is configured to press against the band <NUM>, thereby locking the band <NUM> in position. For example, a free portion of the flexible band <NUM> may be locked to the band clamp <NUM> by tightening the set screw <NUM>, which forces the bottom of the saddle <NUM> into contact with the flexible band <NUM>. The flexible band <NUM> is then locked between the saddle <NUM> and the main body <NUM>.

The main body <NUM> of the band clamp <NUM> may include one or more engagement recesses <NUM> for engagement with an insertion and/or tensioning instrument. For example, two opposed engagement recesses <NUM> may be defined within the side surfaces <NUM>, <NUM>, near the rear <NUM> of the implant <NUM>. Each of the engagement recesses <NUM> may include a slot terminating in a circular divot, for example. It will be appreciated that other suitable engagement features may be used to temporarily couple the implant <NUM> to an instrument, such as inserter or tensioner.

With emphasis on <FIG>, the flexible band <NUM> may initially extend from a first free end <NUM> to an opposite free end <NUM> with a middle portion <NUM> in between. The middle portion <NUM> of the flexible band <NUM> is configured to contact and/or loop around bone. The first free end <NUM> of the flexible band <NUM> may be attached to a leader <NUM>. The leader <NUM> may be a malleable leader configured to be fed around anatomy to wrap the flexible band <NUM> around the anatomy to be fixated. The second free end <NUM> of the flexible band <NUM> may be attached to an anchor <NUM>. The anchor <NUM> may have a geometry such that the anchor <NUM> may be engaged with a mating recess <NUM> in the main body <NUM> of the band clamp <NUM>. As shown in <FIG>, the mating recess <NUM> may be located beneath the band slot <NUM>. The entry of the mating recess <NUM> may be near the rear <NUM> of the implant <NUM> and the exit of the mating recess <NUM> may be into the band slot <NUM> near the bottom <NUM> of the implant <NUM>. The geometry of the mating recess <NUM> is sized and dimensioned such that the anchor <NUM> is receivable and securable within the recess <NUM>.

As shown in <FIG>, the anchor <NUM> may include a split ring body <NUM> with a central through opening <NUM>. The anchor <NUM> may have a nose <NUM> configured to attach to the end <NUM> of the band <NUM>, and a tail <NUM> receivable in the main body <NUM> of the implant <NUM>. The tail <NUM> may include a pair of opposed projections <NUM>. The projections <NUM> may be angled away from a central longitudinal axis B of the anchor <NUM> such that the projections <NUM> have a greater distance apart at the tail end <NUM>. The projections <NUM> may also have a greater thickness than the nose <NUM>. The central opening <NUM> may be in fluid communication with a cut <NUM>. The cut <NUM> may allow the anchor <NUM> to flex and squeeze into the mating recess <NUM> in the main body <NUM>. Once positioned fully within the mating recess <NUM>, the anchor <NUM> may spring back open to prevent disassembly. The anchor <NUM> may also have one or more openings <NUM> configured to engage with a mating instrument to allow disassembly.

As shown in <FIG>, the flexible band <NUM> is inserted with the malleable leader <NUM> first, through recess <NUM> in the main body <NUM>. As shown in <FIG>, the band <NUM> is pulled through until the anchor <NUM> engages and is seated within the recess <NUM> in the implant <NUM>. Engagement between the anchor <NUM> and the recess <NUM> causes the flexible band <NUM> to be securely attached to the main body <NUM> of the implant <NUM>. The first free end <NUM> of the flexible band <NUM> with the malleable leader <NUM> and the middle portion <NUM> of the band <NUM> remain free to be positioned around patient anatomy. As shown in <FIG>, the middle portion <NUM> of the band <NUM> may be looped around bone and the free end <NUM> of the band <NUM> may be threaded back into the implant <NUM> through the band opening <NUM>. As shown in <FIG>, the free end <NUM> may be pulled through the rear <NUM> of the implant <NUM>. After tensioning the band <NUM>, the second locking member <NUM> may be tightened, thereby securing the band <NUM> in the implant <NUM> and maintaining the desired tension around the bone.

Turning now to <FIG>, a band clamp implant assembly <NUM> is shown according to another embodiment. Band clamp implant assembly <NUM> is similar to implant assembly <NUM>, except with a different configuration for the implant <NUM>. Similar to implant <NUM>, implant <NUM> includes a first locking member <NUM> for securing the rod <NUM> and a second locking member <NUM> for securing the band <NUM>. In this embodiment, the band opening <NUM> is located adjacent to the rod slot <NUM> and the band opening <NUM> is oriented parallel to the long axis A of the spinal rod <NUM>.

The implant <NUM> has a first opening or rod slot <NUM> to accept the spinal rod <NUM> and a second opening or band opening <NUM> to accept the flexible band <NUM>. The rod slot <NUM> may be recessed into the front and bottom surfaces <NUM>, <NUM> of the implant <NUM>. The rod slot <NUM> may define a generally c-shaped recess sized and dimensioned to receive the rod <NUM>. The band opening <NUM> may extend through the body between the first and second side surfaces <NUM>, <NUM>. The band opening <NUM> may define a generally cylindrical opening. The implant <NUM> has a first threaded hole <NUM> in fluid communication with the first opening <NUM>. The first threaded locking member <NUM> may be positioned within the first threaded hole <NUM> to secure the spinal rod <NUM> to the implant <NUM>. The implant <NUM> has a second threaded hole <NUM> in fluid communication with the second opening <NUM>. The hole axis of the second threaded hole <NUM> may be generally perpendicular to the hole axis of the band opening <NUM>.

The implant <NUM> has a separate mating recess <NUM> sized and dimensioned to mate with the anchor <NUM> on the flexible band <NUM>. The mating recess <NUM> may be positioned beneath the band opening <NUM> and adjacent to the rod slot <NUM>. The recess <NUM> may extend through the body between the first and second side surfaces <NUM>, <NUM>. The recess <NUM> may define a generally rectangular opening such that the recess <NUM> has a width greater than its height. The flexible band <NUM> may be inserted through the recess <NUM> such that the anchor <NUM> is engaged to the implant <NUM>. In this manner, the anchor <NUM> secures the flexible band <NUM> to the implant <NUM> at free end <NUM> of the band <NUM>. The flexible band <NUM> may be positioned around patient anatomy and the opposite free end <NUM> fed back through the band slot <NUM> in the implant <NUM>, thereby creating a loop. The second threaded locking member <NUM> may be positioned within the second threaded hole <NUM> and moved downwardly to secure the flexible band <NUM> to the implant <NUM>.

The implant <NUM> may define one or more engagement notches <NUM> for engagement with an insertion and/or tensioning instrument. For example, two opposed engagement notches <NUM> may be defined within the side surfaces <NUM>, <NUM>, near the top <NUM> of the implant <NUM>. Each of the engagement notches <NUM> may include a slot extending along the length of the body, for example. It will be appreciated that other suitable engagement features may be used to temporarily couple the implant <NUM> to an instrument, such as inserter and/or tensioner.

According to one example, a method of securing the flexible band <NUM> to the spinal rod <NUM> may involve one or more of the following steps in any suitable order. (<NUM>) Feeding the first free end <NUM> of flexible band <NUM> with the malleable leader <NUM> through the main body <NUM> of the band clamp implant <NUM>, <NUM> and into a recess <NUM>, <NUM> such that the first free end <NUM> and middle portion <NUM> of the flexible band <NUM> pass freely through the main body <NUM> while the second free end <NUM> of the flexible band <NUM> with the anchor <NUM> engages the recess <NUM>, <NUM> and the flexible band <NUM> becomes secured to the band clamp <NUM>, <NUM> at free end <NUM>. (<NUM>) Passing the first free end <NUM> of the flexible band <NUM> around bony anatomy of the posterior spine creating a loop such that the middle portion <NUM> of the flexible band <NUM> contacts bone. (<NUM>) Passing the first free end <NUM> of the flexible band <NUM> back through the band slot <NUM>, <NUM> of the band clamp <NUM>, <NUM>. (<NUM>) Positioning the band clamp <NUM>, <NUM> along the spinal rod <NUM> such that the spinal rod <NUM> is accepted into the rod slot <NUM>, <NUM> of the band clamp <NUM>, <NUM>. (<NUM>) Tightening the first threaded locking component <NUM> in the band clamp <NUM>, <NUM> to secure the spinal rod <NUM> in the rod slot <NUM>, <NUM> to the band clamp <NUM>, <NUM>. (<NUM>) Tensioning the flexible band <NUM> by providing a tensile force to the first free end <NUM> of the flexible band <NUM> thereby causing the loop to become tight around the bony anatomy. (<NUM>) Tightening the second threaded locking component <NUM> in the band clamp <NUM>, <NUM> to force the saddle <NUM> into contact with the flexible band <NUM> in the band slot <NUM>, <NUM> to secure the flexible band <NUM> to the band clamp <NUM>, <NUM>. (<NUM>) Cutting and removing any excess length of the flexible band <NUM> near the band clamp <NUM>, <NUM>. This method allows surgeons to achieve correction and fixation of a spinal deformity by securing the flexible band <NUM> to the spinal rod <NUM>.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. Similar to implant systems <NUM>, <NUM>, the implant <NUM> is configured to secure the flexible band <NUM> to the spinal rod <NUM>. In addition, the implant <NUM> connects the flexible band <NUM> to a fastener, such as a pedicle screw <NUM>, in order to provide additional fixation to the spine. The implant <NUM> is able to secure the flexible band <NUM> directly to the pedicle screw <NUM> without the need for additional rod connectors, which saves space on the construct and alleviates concerns over interference with other hardware and/or anatomy. Although a pedicle screw is exemplified herein, it will be appreciated that the fastener may include any suitable screw, anchor, or other device configured to attach to bone.

With emphasis on <FIG>, the implant system <NUM> includes a band clamp implant <NUM> capable of securing the flexible band <NUM> to the spinal rod <NUM>. The band clamp <NUM> has an implant housing <NUM> with a first portion <NUM> configured for securing the band <NUM> and a second portion <NUM> configured for attaching the rod <NUM> and the pedicle screw <NUM>. The second portion <NUM> may be stepped upward and may extend away from the first portion <NUM>. The medial offset of the band clamp portion <NUM> allows the clamp to be located directly over the lamina for optimal placement of the flexible band <NUM>. The implant housing <NUM> includes an upper surface <NUM>, a lower surface <NUM>, first and second side opposed surfaces <NUM>, <NUM>, a nose or front surface <NUM>, and a back or rear surface <NUM>.

The implant system <NUM> includes an implant housing <NUM>, a locking cap post <NUM>, and a locking nut <NUM>. As shown in <FIG>, the locking cap post <NUM> has two distinct threaded portions: an upper threaded portion <NUM> and a lower threaded portion <NUM>. The upper threaded portion <NUM> is configured to mate with internal threads <NUM> in the locking nut <NUM>. The lower threaded portion <NUM> is configured to mate with internal threads in the head <NUM> of the pedicle screw <NUM>. The lower threaded portion <NUM> may be separated from the upper threaded portion <NUM> by a circumferential groove <NUM>. The lower threaded portion <NUM> may have a major outer diameter greater than the major outer diameter of the upper threaded portion <NUM>. The threads (e.g., handedness, form, angle, pitch, etc.) of the upper portion <NUM> may be the same or different than the threads of the lower portion <NUM>. The upper threaded portion <NUM> may include an internal drive recess <NUM> configured for engagement with a driving instrument. The upper threaded portion <NUM> may also include an internal groove <NUM> for engagement with an insertion instrument. The spinal rod <NUM> may be secured into the head <NUM> of the pedicle screw <NUM> when the locking cap post <NUM> is threaded downwardly through an opening <NUM> in the implant housing <NUM>, and the locking cap post <NUM> may be secured with the locking nut <NUM>.

With reference to <FIG>, the first portion <NUM> of the implant housing <NUM> is configured to secure the flexible band <NUM>. The first portion <NUM> of the implant housing <NUM> defines a band slot <NUM> configured to accept the flexible band <NUM>. The band slot <NUM> may be cylindrical or of suitable shape. The band slot <NUM> is intersected by a hole <NUM>. The hole <NUM> may be in fluid communication with the band slot <NUM>. The hole <NUM> may include a threaded portion <NUM> around an inner periphery of the hole <NUM>. A locking member <NUM> may be positioned within the hole <NUM> to secure the flexible band <NUM> within the band slot <NUM>. The locking member <NUM> may include a fastener or set screw <NUM> and a saddle <NUM>. The set screw <NUM> and saddle <NUM> may be attachable to one another. The saddle <NUM> may define a smooth, non-threaded ring or cylindrical body, and an upper surface of the saddle <NUM> may include one or more prongs <NUM> extending upwardly. The prongs <NUM> may mate with a corresponding recess within the lower surface of the set screw <NUM> to thereby connect the saddle <NUM> to the set screw <NUM>. The set screw <NUM> may include a threaded portion <NUM> around an outer surface, which is configured to threadedly mate with the hole <NUM>.

The set screw <NUM> may define an instrument recess <NUM> in an upper surface configured to be engaged by an instrument, such as a driver, for rotating the set screw <NUM> and moving the locking member <NUM> into the locked position. The set screw <NUM> and saddle <NUM> are attached to one another and are able to travel up and down within the threaded hole <NUM>. The travel of the set screw <NUM> is such that the saddle <NUM> may reversibly interfere with the band slot <NUM> which accepts the flexible band <NUM>. As shown in <FIG>, the flexible band <NUM> may be locked to the implant housing <NUM> by tightening the set screw <NUM>, which forces the saddle <NUM> into contact with the flexible band <NUM>. The flexible band <NUM> is then locked between the saddle <NUM> and the implant housing <NUM>.

The second portion <NUM> of the implant housing <NUM> is configured to engage the head <NUM> of the pedicle screw <NUM>. The second portion <NUM> of the implant housing <NUM> defines a thru hole <NUM> configured to accept the upper portion <NUM> of the locking cap post <NUM>. The thru hole <NUM> may be non-threaded. The second portion <NUM> of the housing <NUM> may include one or more tabs <NUM>. For example, the second portion <NUM> may include two opposed tabs <NUM> extending downwardly on opposite sides of the thru hole <NUM>. The tabs <NUM> may be configured to engage the rod slot <NUM> of the pedicle screw <NUM>. The geometry of the implant housing <NUM> is such that it fits tightly around the head <NUM> of the pedicle screw <NUM>.

As shown in <FIG>, the pedicle screw <NUM> includes a head <NUM> and a shaft <NUM>. The head <NUM> may be in the form of a tulip with two opposing sides spaced apart by a slot <NUM> configured to receive the spinal rod <NUM>. The rod <NUM> may be top-loaded into the tulip body. The tulip head <NUM> may define one or more recesses or engagement features configured to mate with an instrument, such as an inserter. The opposing sides of the tulip head <NUM> may define internal threads configured to mate with the exterior threads on the lower portion <NUM> of the locking cap post <NUM>. The shaft <NUM> may include a threaded shank configured to engage bone. The pedicle screw <NUM> may be polyaxial, monoaxial, uniplanar, or of other suitable design.

With emphasis on <FIG>, the implant housing <NUM> is secured to the pedicle screw <NUM> with the locking cap post <NUM> and the locking nut <NUM>. In <FIG>, the locking cap post <NUM> is positioned through opening <NUM> in the implant housing <NUM> and into contact with the rod <NUM> positioned in the slot <NUM> in the head <NUM> of the pedicle screw <NUM>. In <FIG>, the locking nut <NUM> is secured to the upper portion <NUM> of the locking cap post <NUM>. The locking nut <NUM> has an internal thread <NUM> for engagement with the upper threaded portion <NUM> of the locking cap post <NUM>. The outer geometry of the nut <NUM> is such that the nut <NUM> may be driven by an instrument. The bottom surface of the locking nut <NUM> contacts the upper surface <NUM> of the implant housing <NUM> to secure the implant housing <NUM> to the pedicle screw <NUM>. The implant housing <NUM> is secured to the pedicle screw <NUM> via the force applied by the locking nut <NUM>. The tabs <NUM> on the implant housing <NUM> allow the implant housing <NUM> to remain stable in torsion during tightening by preventing rotation of the implant housing <NUM>.

According to one example, a method of securing the flexible band <NUM> to the spinal rod <NUM> may involve one or more of the following steps in any suitable order: (<NUM>) securing the pedicle screw <NUM> into a pedicle of a vertebra; (<NUM>) positioning the rod <NUM> into the tulip head <NUM> of the pedicle screw <NUM>; (<NUM>) attaching the implant <NUM> to the tulip head <NUM> of the pedicle screw <NUM> with the locking cap post <NUM> by threading the lower threaded portion <NUM> into mating threads within the tulip head <NUM>; (<NUM>) connecting the locking nut <NUM> to the upper threaded portion <NUM> of the locking cap post <NUM> to lock the rod <NUM> in the tulip head <NUM>; (<NUM>) feeding a free end of flexible band <NUM> into the band slot <NUM>; (<NUM>) passing the other free end of the flexible band <NUM> around bony anatomy creating a loop that contacts bone; (<NUM>) passing the other free end of the flexible band <NUM> back through the band slot <NUM> of the band clamp <NUM>; (<NUM>) tensioning the flexible band <NUM> by providing a tensile force to the free end(s) of the flexible band <NUM> thereby causing the loop to become tight around the bony anatomy; (<NUM>) tightening the locking member <NUM> in the band clamp <NUM> to force the saddle <NUM> into contact with the flexible band <NUM> in the band slot <NUM> to secure the flexible band <NUM> to the band clamp <NUM>; and (<NUM>) cutting and removing any excess length of the flexible band <NUM> near the band clamp <NUM>. This method allows surgeons to achieve correction and fixation of a spinal deformity by securing the flexible band <NUM> to the spinal rod <NUM>.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. Similar to implant system <NUM>, the implant <NUM> is configured to secure the flexible band <NUM> to the spinal rod <NUM>. In addition, the implant <NUM> connects the flexible band <NUM> to a bone fastener <NUM>, such as a pedicle screw, in order to provide additional fixation to the spine. Although a pedicle screw is exemplified herein, it will be appreciated that the fastener may include any suitable screw, anchor, or other device configured to attach to bone.

With emphasis on <FIG>, the implant system <NUM> includes a band clamp implant <NUM> capable of securing the flexible band <NUM> to the spinal rod <NUM>. The implant <NUM> includes an integrated screw head <NUM> and band clamp <NUM>. The main body <NUM> includes a first portion or band clamping portion <NUM> configured for securing the band <NUM> and a second portion or screw head portion <NUM> configured for attaching the rod <NUM> and the bone fastener or pedicle screw <NUM>. The first portion <NUM> may be offset laterally and back from the second portion <NUM> of the implant <NUM>. The medial offset of the band clamp portion <NUM> allows the clamp to be located directly over the lamina for optimal placement of the flexible band <NUM>.

The band clamping portion <NUM> has a band slot <NUM> configured to accept the flexible band <NUM>. The band clamping portion <NUM> has a through hole <NUM> intersecting and in fluid communication with the band slot <NUM>. The hole <NUM> may include one or more threads <NUM> around an inner periphery of the hole <NUM>. The locking member <NUM> may be positioned within the hole <NUM> to secure the flexible band <NUM> within the band slot <NUM>. As shown in <FIG>, the locking member <NUM> may include a fastener or set screw <NUM> and a saddle <NUM>. The set screw <NUM> and saddle <NUM> may be attachable to one another. The saddle <NUM> may define a ring or cylindrical body, and an upper surface of the saddle <NUM> may include one or more prongs <NUM> extending upwardly. The prongs <NUM> may mate with a corresponding recess within the lower surface of the set screw <NUM> to thereby connect the saddle <NUM> to the set screw <NUM>. The set screw <NUM> may include one or more external threads <NUM> around an outer surface, which is configured to threadedly mate with the interior threads <NUM> of hole <NUM>. The set screw <NUM> may define an instrument recess <NUM> in an upper surface configured to be engaged by an instrument, such as a driver, for rotating the set screw <NUM> and moving the locking member <NUM> into the locked position.

The set screw <NUM> and saddle <NUM> may be attached to one another such that the set screw <NUM> and saddle <NUM> are able to travel up and down within the threaded hole <NUM>. The travel of the set screw <NUM> is such that the saddle <NUM> may reversibly interfere with the band slot <NUM> which accepts the flexible band <NUM>. The flexible band <NUM> may be locked to the band clamping portion <NUM> of the implant <NUM> by tightening the set screw <NUM>, which forces the saddle <NUM> into contact with the flexible band <NUM>. The flexible band <NUM> is locked between the saddle <NUM> and the band clamping portion <NUM> of the implant <NUM>.

The screw head portion <NUM> may be in the form of a tulip with two opposing sides spaced apart by a slot <NUM> configured to receive the spinal rod <NUM>. The rod <NUM> may be top-loaded into the tulip body. The opposing sides of the tulip head <NUM> may define internal threads <NUM> configured to mate with exterior threads <NUM> on the locking cap <NUM>. The tulip head <NUM> may define one or more recesses or engagement features configured to mate with an instrument, such as an inserter. The screw head portion <NUM> of the implant <NUM> is configured to reversibly attach to the bone fastener <NUM>. The bone fastener <NUM> may be bottom loaded into a bottom opening in the tulip body. The bone fastener <NUM> may include a head and a shaft portion <NUM>. The shaft <NUM> may include a threaded shank configured to engage bone.

With emphasis on <FIG>, the screw head portion <NUM> may retain a clamp <NUM> and a screw head saddle <NUM> configured to reversibly attach to the screw shank <NUM>. The clamp <NUM> may include one or more clamp portions to provide a collar about the head of the bone fastener <NUM>. The clamp <NUM> is configured to grip the bone fastener <NUM> when force is applied onto the clamp <NUM>. The clamp <NUM> may define at least one slit <NUM> formed therein. For example, a pair of slits <NUM> may separate the clamp <NUM> into two clamp portions. The slit(s) <NUM> may be stepped, linear, curved, or otherwise configured. The slit(s) <NUM> may allow for first and second clamp portions to constrict and securely engage the head of the bone fastener <NUM>. A portion of the outer surfaces of the clamp <NUM> may be tapered and an upper portion may define an external lip <NUM> configured to be mated with the saddle <NUM>. An outer surface of the clamp <NUM> may abut and engage an inner surface of the tulip head <NUM> when fully installed and locked in place. When fully installed and locked in place, inner surfaces of the clamp <NUM> may abut and engage the head of the bone fastener <NUM>. The inner surfaces of the clamp <NUM> may include a roughened, textured, or threaded surface configured to improve engagement with the head of the bone fastener <NUM>.

The saddle <NUM> may be introduced downwardly from the top of the tulip head <NUM> to seat on top of the clamp <NUM>. The saddle <NUM> may include a through bore <NUM>. A lower portion of the bore <NUM> may be sized to receive the upper portion of the clamp <NUM>, including external lip <NUM> of the clamp <NUM>. The saddle <NUM> may include a generally rounded outer surface defining a recessed portion or groove <NUM>. The upper surface of the saddle <NUM> may define a convex seat <NUM> that receives the rod <NUM>, when loaded from the top of the tulip <NUM>. The saddle <NUM> may engage interior surfaces of the tulip head <NUM> to prevent upward movement of the clamp <NUM>, thereby locking the clamp <NUM> into engagement with the head of the bone fastener <NUM>.

With emphasis on <FIG>, geometry within the head portion <NUM> allows the clamp <NUM> and saddle <NUM> to be positioned above or below a modular bump <NUM>. In a loading position shown in <FIG>, the saddle <NUM> and clamp <NUM> are in an upward position. The clamp <NUM> and saddle <NUM> are positioned above the modular bump <NUM>, and the clamp <NUM> is able to flex open to accept the head of the screw shank <NUM>. In the locked position shown in <FIG>, the saddle <NUM> and clamp <NUM> are in a downward position. The clamp <NUM> and saddle <NUM> are positioned below the modular bump <NUM>, and the clamp <NUM> is unable to open and prevents the head of the screw shank <NUM> from being released. Once the spinal rod <NUM> is seated in the rod slot <NUM> and onto seat <NUM> of the saddle <NUM>, the threaded locking cap <NUM> is rotated downwardly to secure the spinal rod <NUM> and bone fastener <NUM> in the construct.

Turning now to <FIG>, the flexible band <NUM> may extend from a first free end <NUM> to an opposite second free end <NUM> with a middle portion <NUM> in between. The middle portion <NUM> of the flexible band <NUM> is configured to contact and/or loop around bone. The first free end <NUM> of the flexible band <NUM> may be attached to a leader <NUM>. The leader <NUM> may define an opening for guiding the band <NUM> with an instrument, k-wire, suture, or the like. The leader <NUM> may be a malleable leader configured to be fed around anatomy to wrap the flexible band <NUM> around the anatomy to be fixated. The second free end <NUM> of the flexible band <NUM> may be attached to an anchor or buckle <NUM>. The buckle <NUM> may have a geometry such that the buckle <NUM> may be engaged with a mating recess <NUM> in the implant <NUM>. As shown in <FIG>, the mating recess <NUM> may be separate from and located beneath the band slot <NUM>. The hole axis of the mating recess <NUM> may be offset and transverse to the hole axis of the band slot <NUM>. The geometry of the mating recess <NUM> is sized and dimensioned such that the buckle <NUM> is receivable and securable within the recess <NUM>.

The buckle <NUM> may be conical in shape with one or more grooves <NUM> for engagement with corresponding grooves <NUM> in the mating recess <NUM> in the implant <NUM>. For example, the buckle <NUM> may include a plurality of circumferential grooves <NUM> extending from the widest part of the base of the buckle <NUM>. The buckle <NUM> has at least one flexure cut <NUM> to allow the outer geometry of the buckle <NUM> to squeeze into the mating recess <NUM>. The flexure cut <NUM> may cut through one or more of the grooves <NUM>. When the grooves <NUM> on the buckle align with the grooves <NUM> in the recess <NUM>, the flexure cut <NUM> allows the buckle <NUM> to spring back to its original shape, thus preventing disassembly. The buckle <NUM> includes a loop <NUM>, around which the flexible band <NUM> may be attached. As shown in <FIG>, the free end <NUM> of the band <NUM> may be looped repeatedly around the loop <NUM> of the buckle <NUM> to secure the band <NUM> to the buckle <NUM>. It will be appreciated that other suitable attachment mechanisms, such as knotting, fasteners, adhesives, or the like, may be used to secure the band <NUM> to the buckle <NUM>.

As shown in <FIG>, the implant <NUM> defines an internal recess <NUM> configured to accept the flexible band <NUM> and buckle <NUM>. The internal recess <NUM> defines a plurality of grooves <NUM> that mate with the grooves <NUM> on the buckle <NUM>. As the flexible band <NUM> is passed through the recess <NUM>, from back to front, the buckle <NUM> snaps into the mating grooves <NUM>. After assembly, the flexible band <NUM> is securely attached to the implant <NUM> via buckle <NUM> at free end <NUM> of the band <NUM>.

As shown in <FIG>, after the flexible band <NUM> is passed through the recess <NUM>, the buckle <NUM> snaps into place, thereby securing the flexible band <NUM> to the implant <NUM>. As shown in <FIG>, the tulip body <NUM> is then attached to the screw shank <NUM> by bottom loading the screw <NUM> into the tulip <NUM>. As shown in <FIG>, the spinal rod <NUM> may be placed in the rod slot <NUM> from the top of the tulip <NUM> and secured with the locking cap <NUM>. The locking cap <NUM> also secures the polyaxial screw <NUM> via the downward force onto the screw head saddle <NUM> and clamp <NUM>. As shown in <FIG>, the free end <NUM> of the flexible band <NUM> is passed around the bony anatomy and back into the band clamp portion <NUM> of the implant <NUM> through the band slot <NUM> to create a loop. The loop is tensioned to provide fixation to the bone and then the set screw <NUM> of the locking member <NUM> is tightened downwardly to lock the flexible band <NUM> to the implant <NUM>.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. Similar to implant system <NUM>, the implant <NUM> is configured to secure the flexible band <NUM>, spinal rod <NUM>, and bone fastener <NUM>. In this embodiment, the system <NUM> includes two band clamp portions <NUM>, <NUM> configured to receive and secure the band <NUM> integrally connected to a single tulip-style head <NUM>.

The implant <NUM> includes an integrated screw head <NUM> with two band clamps <NUM>, <NUM>. As shown in the exploded view in <FIG>, the integrated screw head portion <NUM> is the same as integrated tulip-style screw head <NUM> and includes clamp <NUM> and saddle <NUM>, which reversibly attach to the screw shank <NUM>. The geometry within the head portion <NUM> allows the clamp <NUM> and saddle <NUM> to be positioned above or below the modular bump <NUM>. In the loading position when the clamp <NUM> and saddle <NUM> are positioned above the modular bump <NUM>, the clamp <NUM> is able to flex open to accept the head of the screw shank <NUM>. In the locked position when the clamp <NUM> and saddle <NUM> are positioned below the modular bump <NUM>, the clamp <NUM> is unable to open and prevents the head of the screw shank <NUM> from being released. The screw head portion <NUM> includes rod slot <NUM> to accept the spinal rod <NUM> and accepts the threaded locking cap <NUM> to secure the spinal rod <NUM>.

The implant <NUM> includes two band clamps <NUM>, <NUM>, which are separate and distinct from one another. A first band clamp <NUM> sits toward the front of the implant <NUM> and a second band clamp <NUM> sits toward the back of the implant <NUM>. Both clamps <NUM>, <NUM> may be medially offset to the pedicle screw <NUM>, which allows the clamps <NUM>, <NUM> to be located directly over the lamina for optimal placement of the flexible band <NUM>.

Band clamps <NUM>, <NUM> may be similar to band clamp <NUM>. Each band clamp portion <NUM>, <NUM> has a band slot <NUM>, <NUM> for accepting the flexible band <NUM> and a threaded hole <NUM>, <NUM>, which intersects the respective band slot <NUM>, <NUM>. The front band slot <NUM> may be aligned with the back band slot <NUM>. For example, as shown in <FIG>, a central hole axis of the front band slot <NUM> may be coaxial with a central hole axis of the back band slot <NUM> along axis C. The threaded holes <NUM>, <NUM> may be aligned generally perpendicular to axis C. The front threaded hole <NUM> may be positioned generally parallel to the back threaded hole <NUM>.

The implant <NUM> includes two locking members <NUM>, <NUM> receivable in the respective holes <NUM>, <NUM>. Similar to locking member <NUM>, each of the locking members <NUM>, <NUM> may include a set screw <NUM>, <NUM> engaged with a saddle <NUM>, <NUM>, respectively. The set screw <NUM>, <NUM> and saddle <NUM>, <NUM> travel within the respective threaded hole <NUM>, <NUM> such that the saddle <NUM>, <NUM> can reversibly interfere with the band slot <NUM>, <NUM>. Each band slot <NUM>, <NUM> may accept one free end of the flexible band <NUM>, thereby creating a loop therebetween. The set screws <NUM>, <NUM> are threaded downward, which forces the saddles <NUM>, <NUM> to contact the band <NUM>. The force applied by the thread locks the flexible band <NUM> between the saddle <NUM>, <NUM> and the main body of the clamps <NUM>, <NUM>.

According to one example, a method of securing the flexible band <NUM> to the spinal rod <NUM> may involve one or more of the following steps in any suitable order: (<NUM>) securing the pedicle screw <NUM> into a pedicle of a vertebra; (<NUM>) bottom loading the pedicle screw <NUM> into the tulip head <NUM> of the implant <NUM>; (<NUM>) top loading the rod <NUM> into the tulip head <NUM> of the implant <NUM>; (<NUM>) connecting the locking cap <NUM> to the top of the tulip head <NUM> to lock the rod <NUM> and the position of the pedicle screw <NUM>; (<NUM>) feeding a free end of flexible band <NUM> into the band slot <NUM> of the front band clamp <NUM>; (<NUM>) passing the other free end of the flexible band <NUM> around bony anatomy creating a loop that contacts bone; (<NUM>) passing the other free end of the flexible band <NUM> into the band slot <NUM> of the rear band clamp <NUM>; (<NUM>) tensioning the flexible band <NUM> by providing a tensile force to the free end(s) of the flexible band <NUM> thereby causing the loop to become tight around the bony anatomy; (<NUM>) tightening the locking members <NUM>, <NUM> in the band clamps <NUM>, <NUM> to force the respective saddles <NUM>, <NUM> into contact with the flexible band <NUM> in the band slots <NUM>, <NUM> to secure the flexible band <NUM> to the band clamps <NUM>, <NUM>; and (<NUM>) cutting and removing any excess length of the flexible band <NUM> near band clamps <NUM>, <NUM>. This method allows surgeons to achieve correction and fixation of a spinal deformity.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. The implant system <NUM> includes a free band clamp implant <NUM>, which is not intended to secure the flexible band <NUM> to a pedicle screw or spinal rod. The free band clamp <NUM> has a main body defining a band slot <NUM> for receiving the band <NUM> therethrough. The band slot <NUM> may extend through the body of the clamp <NUM> from the front to the back of the implant <NUM>. The body further defines a threaded hole <NUM>, which intersects the band slot <NUM>.

The implant <NUM> is configured to retain a locking member <NUM> which includes a set screw <NUM> and a saddle <NUM>. The set screw <NUM> and saddle <NUM> are attached to one another and able to translate within the threaded hole <NUM>. The set screw <NUM> may have a groove <NUM> on the lower inner portion that mates with one or more tabs or prongs <NUM> on the saddle <NUM>. The tabs or prongs <NUM> on the saddle <NUM> may flex inward when pressed into the set screw <NUM> and snap back to its original shape when it reaches the groove <NUM>. The set screw <NUM> is able rotate independently of the saddle <NUM>.

The band slot <NUM> is able to accept one or both ends of the flexible band <NUM>. When the set screw <NUM> is threaded downward, the saddle <NUM> is forced into contact with the flexible band <NUM>. The force exerted by the threads of the set screw <NUM> secures the flexible band <NUM> in the band slot <NUM> between the saddle <NUM> and a lower surface of the implant <NUM>. The implant <NUM> may include one or more recesses <NUM> or other suitable feature for engagement with an insertion and/or tensioning instrument. The implant <NUM> is configured to lock the flexible band <NUM> in tension after the flexible band <NUM> has been wrapped around bony anatomy to provide fixation. In particular, the band <NUM> may be threaded through the band slot <NUM>, looped around bone, and threaded back through the same band slot <NUM>. The single locking member <NUM> then locks both ends of the band <NUM>, thereby maintaining the tension to the band <NUM>.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. Similar to implant system <NUM>, the implant <NUM> is configured to connect the flexible band <NUM> to the spinal rod <NUM>, which may provide supplemental fixation to pedicle screws, for example. The implant <NUM> may be useful in providing additional fixation in patients with poor bone quality and/or where pedicle screw fixation may be insufficient.

As shown in <FIG>, the implant <NUM> includes a main body <NUM> and a securing member, such as a set screw <NUM>, configured for retaining the spinal rod <NUM> in the implant <NUM>. The main body <NUM> defines a rod slot <NUM> configured to accept the spinal rod <NUM> and a threaded hole <NUM>, which intersects the rod slot <NUM>. The threaded hole <NUM> may be offset relative to the rod slot <NUM>. The set screw <NUM> is able to thread up and down within the threaded hole <NUM> in order to reversibly interfere with the rod slot <NUM>. The lower surface of the set screw <NUM> may be angled in order to press against the rod <NUM>. In a locked position, the lower surface of the set screw <NUM> contacts the rod <NUM>, thereby securing the rod <NUM> in the rod slot <NUM>.

With emphasis on <FIG>, the main body <NUM> defines a band slot <NUM> perpendicular to the axis of the spinal rod <NUM>. The band slot <NUM> may slope from a rear of the implant <NUM> towards rod slot <NUM>. The band slot <NUM> may extend from an upper surface of the implant <NUM> into fluid communication with the rod slot <NUM>. The band slot <NUM> may terminate below the rod slot <NUM> near the bottom of the implant <NUM>. The main body <NUM> of the implant <NUM> further defines an internal recess <NUM> configured to receive an anchor or buckle <NUM>. The internal recess <NUM> intersects the band slot <NUM> and the rod slot <NUM>. The internal recess <NUM> extends from a rear of the main body <NUM> and is angled or sloped downward and into the rod slot <NUM>. The internal recess <NUM> includes one or more grooves <NUM> configured to secure the buckle <NUM> in the implant <NUM>.

The main body <NUM> of the band clamp <NUM> may include one or more engagement recesses <NUM> for engagement with an insertion and/or tensioning instrument. For example, two opposed engagement recesses <NUM> may be defined within the side surfaces near the rear of the implant <NUM>. Each of the engagement recesses <NUM> may include a slot terminating in a circular divot, for example. It will be appreciated that other suitable engagement features may be used to temporarily couple the implant <NUM> to an instrument, such as inserter or tensioner.

As previously described for <FIG>, the flexible band may have two free ends <NUM>, <NUM> with a middle portion <NUM> in between. The middle portion <NUM> of the flexible band <NUM> is intended to contact bone. One free end <NUM> of the flexible band <NUM> may be optionally attached to a malleable leader <NUM>, which can be fed around anatomy to wrap the flexible band <NUM> around the anatomy. The second free end <NUM> of the flexible band <NUM> is attached to the buckle <NUM>.

Similar to buckle <NUM>, the buckle <NUM> may be conical in shape with grooves <NUM> for engagement with grooves <NUM> in the mating recess <NUM> in the main body <NUM> of the implant <NUM>. The buckle <NUM> may include a flexure cut configured to allow the outer geometry to squeeze into the mating recess <NUM>. When the grooves <NUM> on the buckle <NUM> align with the grooves <NUM> in the recess <NUM>, the flexure allows the buckle <NUM> to spring back to its original shape, thus preventing disassembly. The buckle <NUM> may also include a loop, around which the flexible band <NUM> may be attached. The internal recess <NUM> in the main body <NUM> may accept the flexible band <NUM>. The internal recess <NUM> has grooves <NUM> that mate with the grooves <NUM> on the buckle <NUM>. The flexible band <NUM> is passed thru the recess <NUM> and the buckles <NUM> snaps into the mating grooves <NUM>. After assembly, the flexible band <NUM> is securely attached to the main body <NUM> at one end.

As shown in <FIG>, the flexible band <NUM> is passed through the recess <NUM> in the main body <NUM> until the buckle <NUM> snaps into place and the flexible band <NUM> is secured to the main body <NUM>. As shown in <FIG>, the band <NUM> travels beneath the rod slot <NUM>, and the free end <NUM> of the flexible band <NUM> is passed around the bony anatomy. As shown in <FIG>, the free end <NUM> is passed back into the main body <NUM>, beneath the rod slot <NUM> and up through the band slot <NUM> to create a loop. As shown in <FIG>, the implant <NUM> is placed onto the spinal rod <NUM> and the set screw <NUM> is partially tightened to provisionally secure the spinal rod <NUM> into the rod slot <NUM> of the implant <NUM>. The partial tightening allows the flexible band <NUM> to slide freely through the band slot <NUM>. A tensioning device may be used to apply tension to the free end <NUM> of the band <NUM>. The loop is tensioned to provide fixation to the bone. Then, the set screw <NUM> is final tightened. Final tightening of the set screw <NUM> forces the rod <NUM> to contact the flexible band <NUM>, locking the tension in the loop, as well as securing the implant <NUM> to the spinal rod <NUM>.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. Similar to implant system <NUM>, the implant <NUM> is configured to connect the flexible band <NUM> to the spinal rod <NUM> in order to provide fixation to the spine. The band <NUM> is wrapped around bony anatomy, such as the lamina or transverse process, and then a tensile force is applied to translate the spine to the spinal rod <NUM>. After sufficient translation has been achieved to correct the deformity, the tensioned band <NUM> is locked to the spinal rod <NUM> with the band clamp <NUM>. Bands <NUM> may be advantageous in pediatric and neuromuscular deformity cases due to the high prevalence of weak bone and dysmorphic vertebrae which may make pedicle screw placement difficult or impossible.

As shown in <FIG>, the implant <NUM> includes an implant housing <NUM>, drive screw <NUM>, clamp <NUM>, and locking cap <NUM>. The implant housing <NUM> has a rod slot <NUM> configured to accept the spinal rod <NUM> and a through hole <NUM>, which intersects the rod slot <NUM>. The rod <NUM> may be side loaded into the rod slot <NUM>. The hole <NUM> may be generally in line with the rod slot <NUM> such that a hole axis of the hole <NUM> is generally perpendicular to the long axis of the rod <NUM>. The hole <NUM> may define threads therein. The locking cap <NUM> is configured to engage the rod <NUM> located in the rod slot <NUM> to fix the rod <NUM> relative to the implant housing <NUM>. The locking cap <NUM> may be in the form of a threaded set screw with a recess <NUM> in the upper surface of the locking cap <NUM> configured to receive a driver instrument. When rotated, the locking cap <NUM> is able to thread up and down within the threaded hole <NUM> in order to reversibly interfere with the rod slot <NUM>. The lower surface of the locking cap <NUM> may be generally planar in order to press against the rod <NUM>. In a locked position, the lower surface of the locking cap <NUM> contacts the rod <NUM>, thereby securing the rod <NUM> in the rod slot <NUM>.

As shown in <FIG>, the implant housing <NUM> has an elongate channel <NUM>, a pocket <NUM>, and a groove <NUM>. The channel <NUM> is configured to accept the clamp <NUM> and the pocket <NUM> is configured to accept the drive screw <NUM>. The pocket <NUM> may extend from an upper surface of the housing <NUM> and into fluid communication with the channel <NUM>. The channel <NUM> may extend from the pocket <NUM> and through to the lower surface of the housing <NUM>. The channel <NUM> and pocket <NUM> may be coaxial along axis D. The hole axis of the hole <NUM> for the locking cap <NUM> may be generally parallel to axis D. The groove <NUM> in the implant housing <NUM> is configured to receive the flexible band <NUM>. The groove <NUM> is located beneath the rod slot <NUM>. The groove <NUM> in the implant housing <NUM> is positioned such that the groove <NUM> intersects the implant passage <NUM> in the clamp <NUM>.

The housing <NUM> of the band clamp <NUM> may include one or more engagement or holding recesses <NUM> for engagement with an insertion and/or tensioning instrument. For example, two opposed engagement recesses <NUM> may be defined within the side surfaces near the rear of the implant <NUM>. Each of the engagement recesses <NUM> may include a slot from the upper surface and terminating in a circular divot, for example. It will be appreciated that other suitable engagement features may be used to temporarily couple the implant <NUM> to an instrument, such as inserter and/or tensioner.

The drive screw <NUM> includes an enlarged head <NUM> and a shaft <NUM>. The head <NUM> may be define an instrument recess <NUM> in an upper surface configured to engage an instrument, such as a driver. Instrument recess <NUM> in the drive screw <NUM> may be different than instrument recess <NUM> in the locking cap <NUM>. The shaft <NUM> may be threaded along its length. As shown in <FIG>, the drive screw <NUM> may engage the clamp <NUM> such that the clamp <NUM> is able to translate within the channel <NUM> in the implant housing <NUM> between a first position and a second position.

As shown in <FIG>, the clamp <NUM> includes a bore <NUM> configured to accept the shaft <NUM> of the drive screw <NUM> and an intersecting implant passage <NUM> configured to accept the flexible band <NUM>. The bore <NUM> extends from an upper surface of the clamp <NUM> and into fluid communication with the passage <NUM>. The bore <NUM> may be at least partially threaded to engage the external threads of the shaft <NUM> of the drive screw <NUM>. The passage <NUM> extends through the body of the clamp <NUM>.

With emphasis on <FIG>, the pocket <NUM> in the implant housing <NUM> and the head <NUM> of the drive screw <NUM> each contain a groove configured to accept a first retaining ring <NUM>. The first retaining ring <NUM> holds the drive screw <NUM> in position within the implant housing <NUM>. The drive screw <NUM> is able is rotate freely about its long axis but may not translate within the implant housing <NUM>. The implant <NUM> may optionally include a thrust washer <NUM> located between the head <NUM> of the drive screw <NUM> and the bottom of the pocket <NUM> in the implant housing <NUM>. The implant <NUM> may also optionally include a drag ring <NUM> located around the head <NUM> of the drive screw <NUM> within the pocket <NUM> of the implant housing <NUM>. The drag ring <NUM> may be positioned between the retaining ring <NUM> and the thrust washer <NUM>. The clamp <NUM> may define a counter bore and the distal end of the drive screw <NUM> may define a groove configured to accept a second retaining ring <NUM>. The second retaining ring <NUM> prevents the clamp <NUM> from disengaging from the drive screw <NUM> after assembly.

With emphasis on <FIG>, the implant housing <NUM> and the clamp <NUM> each have a surface configured to contact the flexible band <NUM>. The implant housing <NUM> has geometry such that the distance between these surfaces changes depending on where the clamp <NUM> is located within the channel <NUM> in the implant housing <NUM>. As shown in <FIG>, when the clamp <NUM> is located in a first unlocked position within the channel <NUM> in the implant housing <NUM>, the distance between the surfaces is of sufficient space for the flexible band <NUM> to pass thru the implant passage <NUM> in the clamp <NUM>. As shown in <FIG>, when the clamp <NUM> is located in a second locked position within the channel <NUM> in the implant housing <NUM>, the distance between the surfaces is decreased such that the surfaces contact and pinch the flexible band <NUM>, thereby securing the band <NUM> in the implant <NUM>.

According to one example, a method of securing the flexible band <NUM> may involve one or more of the following steps in any suitable order: (<NUM>) feeding a free end of flexible band <NUM> into the rear of the implant housing <NUM> through the band slot <NUM> and out through the front of the implant housing <NUM>; (<NUM>) passing the free end of the flexible band <NUM> around bony anatomy creating a loop that contacts bone; (<NUM>) passing the free end of the flexible band <NUM> back into the same band slot <NUM> at the front of the housing <NUM> beneath the rod slot <NUM> and though to the back of the housing <NUM>; (<NUM>) tensioning the flexible band <NUM> by providing a tensile force to the free end(s) of the flexible band <NUM> thereby causing the loop to become tight around the bony anatomy; (<NUM>) rotating the drive screw <NUM> to move the clamp <NUM> to the locked position, thereby securing the flexible band <NUM> in the clamp <NUM>; and (<NUM>) cutting and removing any excess length of the flexible band <NUM> near the rear of the housing <NUM>. This method allows surgeons to achieve correction and fixation of a spinal deformity. This technique may be advantageous in pediatric and/or neuromuscular deformity cases when traditional pedicle screw fixation is compromised or not possible due to the presence of weak bone or dysmorphic vertebrae.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. The implant <NUM> is configured to lock the flexible band <NUM> in tension without the presence of a spinal rod. Sublaminar bands <NUM> may be used to provide posterior fixation of the spine as an alternative or supplement to pedicle screw instrumentation. The implant <NUM> may be useful in patients with poor bone quality or difficult anatomy where the interface between bone and implant is compromised. For example, patients with pediatric deformity may present with dysmorphic vertebrae, which restrict the use of pedicle screws. The risk of screw pullout may be increased in patients with osteoporosis due to weak connection between the bone and the implant. Additionally, sublaminar bands <NUM> may be used in cases where patients present with fractured anatomy. The band <NUM> may wrapped around the fracture site, such as C2 fracture(s) of the odontoid, and tensioned to provide fixation and promote healing. In these clinical scenarios, it may be advantageous to have implants <NUM> which lock the sublaminar band <NUM> in tension.

As shown in <FIG>, the implant <NUM> may include an outer body <NUM>, a drive screw <NUM>, and a clamping assembly <NUM>. With emphasis on <FIG>, the outer body <NUM> defines first and second band slots <NUM>, <NUM> configured to accept the flexible band <NUM>. The band slots <NUM>, <NUM> may each extend from the upper surface to the lower surface of the body <NUM>. The band slots <NUM>, <NUM> may be elongated in width to accommodate the flat profile of the band <NUM>. With emphasis on <FIG>, the outer body <NUM> defines a recess <NUM> extending from the upper surface to the lower surface of the body <NUM>. The recess <NUM> includes a pocket <NUM> and a through hole <NUM>, where the drive screw <NUM> rests. The band slots <NUM>, <NUM> and recess <NUM> may form ramped surfaces <NUM> toward a lower portion of the body <NUM>. The ramped surfaces <NUM> may be angled such that they have a narrow width toward the top of the body <NUM> and a greater width toward the bottom of the body <NUM>.

The outer body <NUM> defines one or more engagement recesses <NUM> configured to mate with an instrument for providing tension to the flexible band <NUM> before locking. For example, two opposed engagement recesses <NUM> may be defined within the side surfaces near the top of the implant <NUM>. It will be appreciated that other suitable engagement features may be used to temporarily couple the implant <NUM> to an instrument, such as inserter and/or tensioner.

The drive screw <NUM> includes an enlarged head <NUM> and a shaft <NUM>. The head <NUM> may be define an instrument recess <NUM> in an upper surface configured to engage an instrument, such as a driver. The shaft <NUM> may be threaded along its length. The drive screw <NUM> is retained within the outer body <NUM> by a first retaining ring <NUM>. The drive screw retaining ring <NUM> may be in the form of a split ring. The split ring <NUM> may sit in a groove <NUM> in the head <NUM> of the drive screw <NUM>.

With emphasis on <FIG>, the clamping assembly <NUM> includes a carriage <NUM> and a clamp <NUM>. The clamp <NUM> is split into two halves defining a cylindrical opening <NUM> for receiving the carriage <NUM>. When assembled with the carriage <NUM>, the two halves of the clamp <NUM> may be separated by a gap <NUM>. The side surfaces of the clamp <NUM> may be angled surfaces <NUM>, which mimic the ramped surfaces <NUM> in the body <NUM> of the implant <NUM>. The opening <NUM> defines an internal groove <NUM> configured to engage the carriage <NUM>. The carriage <NUM> defines a generally cylindrical body with a central hole <NUM> extending from the upper surface to the lower surface of the carriage <NUM>. The central hole <NUM> may be threaded such that the clamping assembly <NUM> may threaded onto the drive screw <NUM>. The distal end of the drive screw <NUM> has a groove <NUM>, in which a second retaining ring <NUM> sits. The second retaining ring <NUM> may be in the form of a split ring, which prevents the clamping assembly <NUM> from threading off of the drive screw <NUM>. The carriage <NUM> may define an exterior annulus <NUM> forming a middle band around the center of the carriage <NUM>. The annulus <NUM> may be received within the groove <NUM> in the clamp <NUM>, thereby connecting the clamp <NUM> to the carriage <NUM>.

The implant <NUM> may optionally include a drag ring <NUM> located around the head <NUM> of the drive screw <NUM> within the pocket <NUM> of the body <NUM>. The drag ring <NUM> may be in the form of a split ring. The implant <NUM> may also optionally include a friction ring <NUM> to impart friction to the drive screw <NUM>. The friction ring <NUM> may be in the form of a washer located between the head <NUM> of the drive screw <NUM> and the bottom of the pocket <NUM> in the body <NUM> of the implant <NUM>.

With emphasis on <FIG>, when the drive screw <NUM> is actuated, the clamping assembly <NUM> may translate up and down. As shown in <FIG>, the inner surface of the outer body <NUM> and the outer surface of the clamp <NUM> have mating ramped geometries <NUM>, <NUM> such that there is clearance for the flexible band <NUM> to pass through the implant <NUM> when the clamping assembly <NUM> is in a first open position. In the open position, the clamping assembly <NUM> is in a downward location to allow the band <NUM> to pass through the band slots <NUM>, <NUM>. As shown in <FIG>, actuation of the drive screw <NUM> translates the clamping assembly <NUM> into a locked second position, in which the clamping assembly <NUM> contacts the flexible band <NUM> against the inner surface of the outer body <NUM>, thus locking the band <NUM>. In the locked position, the clamping assembly <NUM> is in an upward location which pinches the band <NUM> between the clamp <NUM> and the body <NUM> of the implant <NUM>.

According to one example, a method of securing the flexible band <NUM> to the spinal rod <NUM> may involve one or more of the following steps in any suitable order: (<NUM>) while the clamping assembly <NUM> is in a downward open position as shown in <FIG>, feeding a free end of flexible band <NUM> through the first band slot <NUM>; (<NUM>) passing the other free end of the flexible band <NUM> around bony anatomy creating a loop that contacts bone; (<NUM>) passing the other free end of the flexible band <NUM> through the second band slot <NUM>; (<NUM>) tensioning the flexible band <NUM> by providing a tensile force to the free end(s) of the flexible band <NUM> thereby causing the loop to become tight around the bony anatomy; (<NUM>) rotating the drive screw <NUM> to move the clamp <NUM> upward into the locked position as shown in <FIG>, thereby securing the flexible band <NUM> in the implant <NUM>; and (<NUM>) cutting and removing any excess length of the flexible band <NUM>.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. Implant <NUM> is similar to implant <NUM> except only a single band slot <NUM> is provided, which accepts both ends of the band <NUM>. The single band slot <NUM> extends from the top to the bottom of the implant <NUM>. Actuation of the drive screw <NUM> causes the clamping assembly <NUM> to translate up and down within the implant <NUM>. In <FIG>, the clamping assembly <NUM> is shown in the open configuration with the clamp <NUM> positioned downward in the body <NUM>. The band <NUM> may be threaded through the single band slot <NUM>, wrapped around bone, and then threaded back through the same band slot <NUM>. After tensioning the band <NUM>, the clamping assembly <NUM> may be moved upward to lock the band <NUM>. The ramped geometry <NUM> of the clamp <NUM> contacts the band <NUM> and secures the band <NUM> against the ramped geometry <NUM> of the outer body <NUM>. Since the opposite side of the clamp <NUM> and recess <NUM> is absent the second band slot, the mating geometry may be generally planar or of other suitable configuration.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. Similar to implant <NUM>, the implant <NUM> includes a single band slot <NUM>, which accepts both ends of the band <NUM>. In this embodiment, a rotatable cam lock <NUM> is used to secure the band <NUM> in the implant <NUM>.

With emphasis on <FIG>, the implant <NUM> includes an outer body <NUM> and a cam lock <NUM>. The outer body <NUM> has a band slot <NUM> configured to accept the flexible band <NUM>. The band slot <NUM> may extend from the upper surface to the lower surface of the body <NUM>. The band slot <NUM> may be elongated in width to accommodate the flat profile of the band <NUM>. The outer body <NUM> defines a recess <NUM> extending from the upper surface to the lower surface of the body <NUM>. The recess <NUM> includes a pocket <NUM> and a through hole <NUM>, where the cam lock <NUM> rests. The outer body <NUM> may include one or more engagement recesses <NUM> configured to mate with an instrument for providing tension to the flexible band <NUM> before locking.

The cam lock <NUM> may include a head <NUM> with a cam body <NUM>. The head <NUM> may be define an instrument recess <NUM> in an upper surface configured to engage an instrument, such as a driver. The cam body <NUM> is offset relative to the longitudinal axis of the head <NUM> such that a cam engagement surface <NUM> projects laterally outward. The cam lock <NUM> is retained within the outer body <NUM> by a retaining ring <NUM>. The cam lock retaining ring <NUM> may be in the form of a split ring. The split ring <NUM> may sit in a groove <NUM> near the top of the head <NUM> of the cam lock <NUM>.

The implant <NUM> may optionally include a drag ring <NUM> located around the head <NUM> of the cam lock <NUM> and within the pocket <NUM> of the body <NUM>. The drag ring <NUM> may be in the form of a split ring located beneath the retaining ring <NUM>. The implant <NUM> may also optionally include a friction ring <NUM> to impart friction to the cam lock <NUM>. The friction ring <NUM> may be in the form of a split ring located between the head <NUM> of the cam lock <NUM> and the bottom of the pocket <NUM> in the body <NUM> of the implant <NUM>.

With emphasis on <FIG>, the cam lock <NUM> may be rotated into and out of engagement with the band slot <NUM> to secure the band <NUM> therein. As shown in <FIG>, the cam lock <NUM> may turn within the outer body <NUM> such that there is space to pass the flexible band <NUM> through the slot <NUM> in the outer body <NUM> when the cam lock <NUM> is in a first open position. As shown in <FIG>, when the cam lock <NUM> is actuated, the cam surface <NUM> is configured to contact the flexible band <NUM> against the inner surface of the outer body <NUM>, thereby locking the band <NUM> in the implant <NUM>. <FIG> shows a bottom view of the implant <NUM> with the cam lock <NUM> in the unlocked position, thereby allow the band <NUM> to pass freely through slot <NUM>. <FIG> shows the implant <NUM> with the cam lock <NUM> in the locked position, thereby locking the band <NUM> in the implant <NUM>.

According to one example, a method of securing the flexible band <NUM> to bone may involve one or more of the following steps in any suitable order: (<NUM>) while the cam body <NUM> is in its open position, feeding a free end of flexible band <NUM> through the band slot <NUM>; (<NUM>) passing the free end of the flexible band <NUM> around bony anatomy creating a loop that contacts bone; (<NUM>) passing the free end of the flexible band <NUM> back through the same band slot <NUM>; (<NUM>) tensioning the flexible band <NUM> by providing a tensile force to the free end(s) of the flexible band <NUM> thereby causing the loop to become tight around the bony anatomy; (<NUM>) rotating the cam lock <NUM> to move the cam body <NUM> into the locked position as shown in <FIG>, thereby securing the flexible band <NUM> in the implant <NUM>; and (<NUM>) cutting and removing any excess length of the flexible band <NUM>.

Turning now to <FIG>, a band clamp implant assembly or system <NUM> is shown according to one embodiment. Similar to implant <NUM>, the implant <NUM> includes a single band slot <NUM>, which accepts both ends of the band <NUM>. In this embodiment, one or more spring blocks <NUM> are used to secure the band <NUM> in the implant <NUM>.

The implant <NUM> includes a housing <NUM> and a pair of spring blocks <NUM>. The band slot <NUM> in the housing <NUM> is configured to accept the flexible band <NUM>. The band slot <NUM> may extend from an upper surface to a lower surface of the housing <NUM>. The housing <NUM> may be bowed or convex along the upper surface. A pair of parallel openings <NUM> may extend from the front to the back of the housing <NUM> on either side of the band slot <NUM>. The openings <NUM> may be in fluid communication with the band slot <NUM>. The openings <NUM> may be oriented generally perpendicular to the band slot <NUM>.

The spring blocks <NUM> may include a plurality of cuts or slits or may comprise a shape-memory material, for example, configured to allow the blocks <NUM> to be deformed. After deformation, the blocks <NUM> are then able to return to their original shape. Each of the springs blocks <NUM> may define a generally quadrilateral cuboid body. For example, the spring blocks <NUM> may have generally rectangular cuboid body with a length greater than its width and height. One or more slits may run along its length. The spring blocks <NUM> sit inside the housing <NUM> on either side of the band slot <NUM> such that the spring blocks <NUM> protrude into the band slot <NUM>.

The spring blocks <NUM> may be elastically compressed to allow passage of the flexible band <NUM> through the slot <NUM>. The spring blocks <NUM> may define a chamfer <NUM> on the leading edge to allow engagement of an instrument to compress the spring blocks <NUM> out of the slot <NUM>, thus allowing passage of the flexible band <NUM>. The flexible band <NUM> is then tensioned to provide fixation to the anatomy. When the instrument is removed from the implant <NUM>, the spring blocks <NUM> return to their resting position and contact the band <NUM>. The contact between the spring blocks <NUM> and the flexible band <NUM> secures the tension in the band <NUM>.

Turning now to <FIG>, a cross connector assembly or system <NUM> is shown according to one embodiment. The implant <NUM> is a cross connector which connects to two rods <NUM> and secures two separate flexible bands <NUM> around bone. With reference to <FIG>, the implant <NUM> includes first and second arms <NUM>, <NUM> configured to translate toward and away from one another. The first arm <NUM> includes a first open clamp <NUM> configured to receive the first rod <NUM>, and the second arm <NUM> includes a second open clamp <NUM> configured to receive the second rod <NUM>. First and second rods <NUM> may extend generally parallel to one another.

As shown in <FIG>, the first arm <NUM> may define a central longitudinal bore <NUM> sized and dimensioned to accept an extension <NUM> of the second arm <NUM>, which allows the arms <NUM>, <NUM> to translate with respect to one another. In this manner, the overall length of the implant <NUM> may be adjusted based on the distance between the first and second rods <NUM>. A first fastener or set screw <NUM> may be located at the medial end the first arm <NUM>. The set screw <NUM> may be threaded downward to lock translation and the distance of the two arms <NUM>, <NUM>. It will be appreciated that the configuration of the bore <NUM> and extension <NUM> may be reversed or otherwise configured to allow for translation between the two arms <NUM>, <NUM>.

Each arm <NUM>, <NUM> has an open clamp <NUM>, <NUM> to accept the respective spinal rod <NUM> and a set screw <NUM>, <NUM> to secure the implant <NUM> to the spinal rods <NUM>. The first clamp <NUM> defines a first opening, recess, or rod slot <NUM> sized and dimensioned to accept the spinal rod <NUM>. The rod slot <NUM> may define a generally c-shaped recess sized and dimensioned to receive the first rod <NUM> when bottom loaded into the implant <NUM>. The hook of the clamp <NUM> may be facing inward toward the center of the implant <NUM>. The second clamp <NUM> defines a second opening, recess, or rod slot <NUM> sized and dimensioned to accept the spinal rod <NUM>. The rod slot <NUM> may define a generally c-shaped recess sized and dimensioned to receive the second rod <NUM> when bottom loaded into the implant <NUM>. The hook of the clamp <NUM> may be facing outward away from the center of the implant <NUM>. It will be appreciated that the slots <NUM>, <NUM> may be faced in any suitable direction for attachment to the rods <NUM>.

The first arm <NUM> defines a first threaded hole <NUM> in fluid communication with the rod slot <NUM>. The second locking member or set screw <NUM> is positionable within the first threaded hole <NUM>, and when in a downward position, a bottom surface of the set screw <NUM> is configured to contact and secure the spinal rod <NUM> within the clamp <NUM>. Similarly, the second arm <NUM> defines a second threaded hole <NUM> in fluid communication with the rod slot <NUM>. The third locking member or set screw <NUM> is positionable within the second threaded hole <NUM>, and when in a downward position, a bottom surface of the set screw <NUM> is configured to contact and secure the spinal rod <NUM> within the clamp <NUM>.

Each of the arms <NUM>, <NUM> define a thru slot or band slot <NUM>, <NUM> configured to accept the flexible bands <NUM>. The band slots <NUM>, <NUM> may be located generally parallel to one another. The band slots <NUM>, <NUM> may be located such that the slots <NUM>, <NUM> are positioned above the lamina. A threaded hole <NUM>, <NUM> sits above and in fluid communication with each band slot <NUM>, <NUM> to accept a threaded set screw <NUM>, <NUM>. Each of the threaded set screws <NUM>, <NUM> may be threaded downward to secure the flexible bands <NUM>. Each of the set screws <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may define an instrument recess configured to be engaged by an instrument, such as a driver, for rotating the set screws <NUM>, <NUM>, <NUM>, <NUM>, <NUM> into the downward locked positions.

Turning now to <FIG>, alternative embodiments consistent with the principles of the present disclosure are illustrated. These embodiments allow locking a flexible band in tension without the presence of a spinal rod.

Referring to <FIG>, a band clamp <NUM> is illustrated. Band clamp <NUM> is capable of securing a flexible band in tension. Band clamp <NUM> has a main body <NUM> with a first opening <NUM> to accept a flexible band, which may be referred to as a band slot <NUM> and a second opening <NUM> located beneath first opening <NUM>, which may be referred to as an anchor slot <NUM>. Main body <NUM> has a threaded hole <NUM> in communication with band slot <NUM>. A threaded locking member <NUM> may be positioned within the threaded hole to contact the flexible band and secure it to main body <NUM>.

Threaded locking member <NUM> may include a threaded set screw <NUM> coupled to a saddle <NUM>. Set screw <NUM> may have a slot <NUM> to accept an upper portion <NUM> of saddle <NUM>. A hole <NUM> through the long axis of set screw <NUM> may be aligned with a corresponding hole <NUM> along the long axis of saddle <NUM> when upper portion <NUM> of saddle <NUM> is positioned within slot <NUM> in set screw <NUM>. A pin <NUM> may be pressed into holes <NUM> and <NUM> in an aligned positioned of set screw <NUM> and saddle <NUM> to prevent saddle <NUM> from dislodging from the set screw.

In one exemplary embodiment shown in <FIG>, set screw <NUM> and saddle <NUM> may be permanently engaged with main body <NUM> after assembly. Main body <NUM> has geometry such that set screw <NUM> is threaded into main body <NUM> from the top and saddle <NUM> is inserted into slot <NUM> in set screw <NUM> from band slot <NUM>. Saddle <NUM> is sized such that it cannot pass through the minor diameter of the threads in main body <NUM>, therefore preventing disassembly when set screw <NUM> is threaded upward. Main body <NUM> has geometry such that saddle <NUM> cannot rotate within main body <NUM>, but can translate up and down with actuation of set screw <NUM>. Main body <NUM> also has relief space above band slot <NUM> such that saddle <NUM> is able to be positioned above band slot <NUM> when set screw <NUM> is threaded upward, allowing free passage of the flexible band through band slot <NUM>.

In an exemplary embodiment shown in <FIG>, set screw <NUM> and saddle <NUM> may be threaded into and out of main body <NUM>. Main body <NUM> has a groove <NUM> through the threads to accept a mating bump <NUM> on saddle <NUM>, which prevents saddle <NUM> from rotating when set screw <NUM> is threaded up and down within main body <NUM>.

As shown in <FIG>, an exemplary flexible band <NUM> consistent with the principles of the present disclosure is illustrated. Flexible band <NUM> has a first end <NUM>, a second end <NUM>, and a middle portion <NUM> in between. Middle portion <NUM> is intended to contact bone. First end <NUM> is attached to a leader <NUM>. A leader <NUM> may be fed around anatomy to wrap flexible band <NUM> around the anatomy to be fixated. Leader <NUM> may be malleable or rigid. Second end <NUM> of flexible band <NUM> is attached to an anchor <NUM>. Anchor <NUM> has geometry such that it may be engaged with a mating recess in the main body of the band clamp. As shown in <FIG>, anchor <NUM> may have a cut <NUM> which allows anchor <NUM> to contract when first entering anchor slot <NUM> and then expand into a mating recess in anchor slot <NUM> in main body <NUM>. Once positioned fully within the mating recess, anchor <NUM> may spring back open to prevent disassembly. Anchor <NUM> may also have a feature to engage with a mating instrument to allow disassembly.

<FIG> illustrates a band clamp system or assembly <NUM>, including band clamp <NUM>, flexible band <NUM>, leader <NUM>, and anchor <NUM>. Main body <NUM> has anchor slot <NUM> located beneath band slot <NUM>. The geometry of anchor slot <NUM> is such that it can engage anchor <NUM> of flexible band <NUM>. As shown in <FIG>, flexible band <NUM> is inserted, leader <NUM> end first, through anchor slot <NUM> in main body <NUM> and pulled through until anchor <NUM> engages a mating recess <NUM>. As shown in <FIG>, engagement between anchor <NUM> and the mating recess causes flexible band <NUM> to become securely attached to main body <NUM>. <FIG> illustrates flexible band engaged with main body <NUM> of band clamp <NUM>.

As shown in <FIG>, the free end of flexible band <NUM> is then wrapped around the patient anatomy to be fixated and passed back through band slot <NUM> to create a loop. As shown in <FIG>, the loop is tensioned by pulling on the free end of flexible band <NUM> with a tensioning instrument or ratcheting tensioner <NUM>. Once the desired amount of tension is placed on flexible band <NUM> to achieve fixation, set screw <NUM> is threaded downward forcing the saddle to contact and secure flexible band <NUM> in band clamp <NUM>, as shown in <FIG>.

<FIG> illustrate a band clamp system <NUM>, including band clamp <NUM>, flexible band <NUM>, and leader tip <NUM>. Band clamp system <NUM> is a band clamp <NUM> that is connected to flexible band <NUM>. Band clamp <NUM> has a set screw component <NUM> and a saddle component <NUM> for securing flexible band <NUM> similar to what has been previously described with respect to <FIG>. Flexible band <NUM> has leader tip <NUM> on a first end for passage around bony anatomy. Leader tip <NUM> may be malleable in order to shape it to more easily pass around anatomy.

As shown in <FIG>, band clamp <NUM> has two slots. One slot <NUM> is where flexible band <NUM> is looped and sewn into place at a sewn portion <NUM> to create one assembly at a second end. The second slot <NUM> is where the opposite end of flexible band <NUM> is fed back through band clamp <NUM> to create a loop. Band clamp <NUM> has a threaded hole and relief space intersecting the upper band slot (<FIG>). The set screw and saddle components are coupled together and travel up and down such that the set screw is always engaged with the threaded hole and the saddle is positioned within the relief space. The relief space is shaped such that the saddle cannot rotate during translation.

The set screw may be positioned in an up position where the saddle is located in the relief space above the band slot and the band slot is free to accept flexible band as shown in <FIG>. When the set screw is threaded downward the saddle may secure flexible band by contacting it in the band slot as shown in <FIG>. Band clamp <NUM> may also have a feature for engagement with an insertion and tensioning instrument. <FIG> illustrates flexible band <NUM> looped back through band clamp <NUM>.

<FIG> illustrates an exemplary embodiment of a band clamp assembly <NUM> consistent with the principles of the present disclosure. Here, band clamp <NUM> is similar to previously described band clamps, however, band clamp <NUM> has one slot for sewing a portion of a flexible rod which is then looped back into the same slot.

Turning now to <FIG>, an instrument assembly <NUM> of a tensioning instrument may include an inserter fork <NUM>, an outer sleeve <NUM>, and tension indicator <NUM> consistent with the principles of the present disclosure is illustrated. Assembly <NUM> may be used with a tensioning instrument (such as, for example, tensioning instrument <NUM>) to apply tension to one of band clamp assemblies <NUM>, <NUM>, <NUM>, and <NUM> (see, <FIG>). <FIG> depicts inserter fork <NUM>, <FIG> depicts outer sleeve <NUM>, and <FIG> depicts tension indicator <NUM>.

Inserter fork <NUM> and outer sleeve <NUM> couple together via a thread. A distal end of inserter fork <NUM> has geometry for engagement with the band clamps previously described, for example band clamps with assemblies <NUM>, <NUM>, <NUM>, and <NUM>.

A distal end of inserter fork <NUM> is splayed at rest in order to accept a band clamp. Outer sleeve <NUM> may be threaded distally, which squeezes the inserter fork into a locked position in order to securely hold the band clamp as shown in <FIG>.

Tension indicator <NUM> has a piston <NUM> that rides inside a barrel <NUM>. Piston <NUM> contacts a spring <NUM> such that the force required to move piston <NUM> is directly correlated with the distance the piston has moved. Tension indicator <NUM> has a handle attachment <NUM> coupled to piston <NUM> via a pin through a slot in the barrel. Handle attachment <NUM> may slide over barrel <NUM>, which translates piston <NUM> and compresses spring <NUM>. Barrel <NUM> may have etchings <NUM> on it such that the position of handle attachment <NUM> indicates the amount of force exerted on spring <NUM> as shown in <FIG>. Handle attachment <NUM> has geometry <NUM> to engage with a ratcheting tensioner such as tensioning instrument <NUM>.

As shown in <FIG>, tension indicator <NUM> has a thru hole <NUM> to accept inserter fork <NUM> and a button assembly <NUM> to engage with inserter fork <NUM>. Button <NUM> is positioned within a slot <NUM> in the barrel <NUM> and coupled via a pin. The pin is positioned within a slot in the button such that the button can slide up and down within the slot in barrel <NUM>. Two compression springs <NUM> are captured between the button <NUM> and barrel <NUM> causing button <NUM> to remain in an up position at rest. Inserter fork <NUM> has a slot to mate with the button assembly <NUM> on the tension indicator <NUM>. Button <NUM> has geometry such that inserter fork <NUM> can slide through button <NUM> freely when button <NUM> is pressed into the down position as shown in <FIG>. Inserter fork <NUM> and barrel <NUM> have mating geometry which prevents rotation between the two parts during engagement as shown in <FIG>.

Handle attachment <NUM> of the tension indicator <NUM> has a feature to engage with the ratcheting tensioner <NUM>. Ratcheting tensioner <NUM> may tension flexible band causing a force to be applied to spring <NUM> in tension indicator <NUM>. Therefore, the instrument assembly is able to indicate to the user how much tension is in the band based on how far the spring is compressed. This is indicated by the etchings on the barrel. It is advantageous for the user to know how much tension is in the band in order to achieve adequate fixation.

An exemplary method of fixating the spine using band clamp assembly <NUM>, instrument assembly <NUM>, and ratcheting tensioner <NUM> will described in the following steps:.

Referring now to FIGS. 82A-96D, band clamp implant systems and components thereof consistent with the principles of the current disclosure are illustrated. <FIG> illustrates an exemplary implant housing or band clamp <NUM> with a hole <NUM> to accept a spinal rod <NUM>. Hole <NUM> may be oriented along a long axis of band clamp <NUM> such that the end of the rod <NUM> can be inserted into band clamp <NUM> as shown in <FIG>. Band clamp <NUM> has a threaded hole <NUM> which intersects hole <NUM> accepting spinal rod <NUM>. A threaded set screw <NUM> may be positioned within threaded hole <NUM> and actuated in order to secure spinal rod <NUM> in band clamp <NUM> as shown in <FIG>. Band clamp <NUM> has a hole <NUM> to accept a flexible band <NUM>. Hole <NUM> may be at least partially oriented along the axis of band clamp <NUM> as shown in <FIG>. Band clamp has a threaded hole <NUM> which intersects hole <NUM> accepting flexible band <NUM>. A threaded set screw <NUM> may be positioned within threaded hole <NUM> and actuated in order to secure flexible band <NUM> in band clamp <NUM> as shown in <FIG>.

As shown in <FIG>, exemplary embodiments consistent with the principles of the present disclosure may be used to provide additional fixation to spinal rod constructs by wrapping the flexible band around anatomy and securing it to the spinal rod. Band clamp <NUM> is placed onto the end of rod <NUM> and locked in place by tightening set screw <NUM>. Flexible band <NUM> is wrapped around the anatomy which is to be fixated, creating a loop. Both ends of band <NUM> may be passed back through band clamp <NUM> and tensioned to provide fixation, after which threaded set screw <NUM> is tightened to secure band <NUM>. Alternatively, as shown in <FIG>, two band clamps may be placed onto the spinal rod construct and the flexible band could be connected between them. The band clamp is attached to the end of the rod on each side of the spine. The flexible band is wrapped around the anatomy which is to be fixated. One end of the band is placed into the band clamp on each side of the spine. The flexible band is tensioned and the secured to achieve fixation.

Referring now to <FIG>, exemplary embodiments consistent with the principles of the present disclosure are illustrated. In <FIG>, a band clamp <NUM> has a slot <NUM> to accept an anchor component <NUM>. Band clamp <NUM> has a hole <NUM> to accept a spinal rod <NUM> as shown in <FIG>. Hole <NUM> is oriented along a long axis of band clamp <NUM> such that the end of the rod can be inserted into band clamp <NUM> as shown in <FIG>. Band clamp <NUM> has a threaded hole <NUM> which intersects hole <NUM> accepting spinal rod <NUM>. A threaded set screw <NUM> may be positioned within threaded hole <NUM> and actuated in order to secure spinal rod <NUM> in band clamp <NUM> as shown in <FIG>.

A flexible band <NUM> initially has two ends <NUM>, <NUM> with a middle portion <NUM> in between as shown in <FIG>. Middle portion <NUM> of flexible band <NUM> is configured to contact bone. First free end <NUM> of flexible band <NUM> is attached to a malleable leader <NUM>. Malleable leader <NUM> may be directed around anatomy to wrap flexible band <NUM> around the anatomy to be fixated. Second free end <NUM> of flexible band <NUM> is attached to anchor component <NUM>. Anchor component is illustrated in <FIG>.

Band clamp <NUM> has anchor slot <NUM> essentially in-line with the long axis of band clamp <NUM>. The geometry of anchor slot <NUM> is such that it can engage anchor component <NUM> of flexible band <NUM>. As shown in <FIG>, flexible band <NUM> is inserted, malleable leader <NUM> end first, through anchor slot <NUM> in band clamp <NUM> and pulled through until anchor <NUM> engages a recessed feature <NUM> (illustrated in <FIG>). Engagement between anchor <NUM> and recessed feature <NUM> causes flexible band <NUM> to become securely attached to band clamp <NUM> as shown in <FIG>.

Band clamp <NUM> may be used to provide additional fixation to spinal rod constructs by wrapping the flexible band around anatomy and securing it to the spinal rod. Band clamp may be placed onto the end of rod <NUM> and locked in place by tightening set screw <NUM>. Flexible band <NUM> is inserted into band clamp <NUM> until anchor <NUM> engages band clamp <NUM>. The free end of flexible band <NUM> is wrapped around the anatomy which is to be fixated. Band clamp <NUM> (described above) may be similarly positioned onto a spinal rod on the opposite side of the spine. The free end of flexible band <NUM> may be inserted into the band clamp on the opposite side of the spine and tensioned to create fixation. The set screw on the implant housing is then tightened to secure the band as shown in <FIG>.

<FIG> illustrates a spinal rod <NUM> with an integrated slot <NUM> to accept an anchor component <NUM>. Anchor slot <NUM> is essentially in-line with a long axis of rod <NUM> and has geometry such that it can engage anchor component <NUM> of a flexible band <NUM>. Flexible band <NUM> is inserted, for example with a malleable leader end first as previously described, through anchor slot <NUM> in rod <NUM> and pulled through until anchor <NUM> engages a recessed feature <NUM> as shown in <FIG>. Engagement between anchor <NUM> and recessed feature <NUM> causes flexible band <NUM> to become securely attached to rod <NUM> (<FIG>).

Rod <NUM> may be used to provide additional fixation to spinal rod constructs by wrapping the flexible band around anatomy and securing it to the spinal rod. Rod <NUM> allows the surgeon to add band fixation without the need for connecting additional implants to the spinal rod. The flexible band is inserted into the integrated rod implant until the anchor component engages the implant. The free end of the flexible band is then wrapped around the anatomy which is to be fixated. Band clamp <NUM> may be similarly positioned onto a spinal rod on the opposite side of the spine. The free end of the flexible band may be inserted into the implant housing on the opposite side of the spine and tensioned to create fixation. The set screw on the implant housing is then tightened to secure the band (<FIG>).

Alternatively, the rod on the opposite side of the spine may be a rod <NUM> with an integrated band clamp <NUM> as shown in <FIG>. Band clamp portion <NUM> may have a hole <NUM> to accept a flexible band <NUM> in communication with a threaded hole <NUM> for housing a set screw locking member <NUM> as shown in <FIG>. Flexible band <NUM> could be inserted into rod <NUM> with integrated anchor slot <NUM> on one side of the spine and then wrapped around the anatomy which is to be fixated. The free end of the flexible band is then placed into rod <NUM> with integrated band clamp <NUM> on the opposite side of the spine and tensioned to provide fixation (<FIG>).

As shown in <FIG>, a spinal rod connector <NUM> with an integrated slot <NUM> to engage an anchor component <NUM> is illustrated. Connector <NUM> has a thru hole <NUM> to accept a spinal rod <NUM>. Connector <NUM> may be slid onto rod <NUM> prior to inserting rod <NUM> into pedicle screws <NUM> such that connector <NUM> is positioned on spinal rod <NUM> between two pedicle screws <NUM> as shown in <FIG>. Anchor slot <NUM> is offset laterally from rod slot <NUM> and has geometry such that it can engage anchor component <NUM> of flexible band <NUM>. Flexible band <NUM> is inserted, for example via a malleable leader end first as previously described, through anchor slot <NUM> and pulled through until anchor <NUM> engages a recessed feature in anchor slot <NUM> (<FIG>). Engagement between anchor <NUM> and the recessed feature causes flexible band <NUM> to become securely attached to connector <NUM> (<FIG>).

As shown in <FIG>, connector <NUM> is placed onto spinal rod <NUM> between two pedicle screws <NUM>. Flexible band <NUM> is inserted into anchor slot <NUM> until anchor component <NUM> engages connector <NUM>. The free end of flexible band <NUM> is then wrapped around the anatomy which is to be fixated. Band clamp <NUM> or similar implant may be positioned onto a spinal rod on the opposite side of the spine. The free end of the flexible band may be inserted into the implant on the opposite side of the spine and tensioned to create fixation. Tensioning of the flexible band causes the envisioned implant to slide along the first spinal rod until it contacts the pedicle screw (<FIG>). The tension in the flexible band creates the fixation. The set screw in the implant on the second spinal rod is then tightened to secure the band (<FIG>).

As shown in <FIG>, providing supplemental fixation to the spine using a flexible band is illustrated. Flexible band <NUM> has a loop on one end <NUM> through which a spinal rod is configured to be received as shown in <FIG>. The opposite end of the band is free to be wrapped around boney anatomy. A spinal rod <NUM> is inserted through the loop in flexible band <NUM> and then placed into pedicle screws <NUM>. The free end of the band is then wrapped around the anatomy which is to be fixated. Band clamp <NUM> or a similar implant may be positioned onto a spinal rod on the opposite side of the spine. The free end of the flexible band may be inserted into band clamp <NUM> on the opposite side of the spine and tensioned to create fixation. Tensioning of the flexible band causes the band loop to slide along the first spinal rod until it contacts one of pedicle screws <NUM> (<FIG>). The tension in flexible band <NUM> creates the fixation. The set screw in the implant on the second spinal rod is then tightened to secure the band (<FIG>).

Turning now to <FIG>, an exemplary instrument to apply tension to a flexible band is disclosed. Tensioner <NUM> consists of an adjustable head <NUM>, a fixed handle assembly <NUM>, a pivoting handle assembly <NUM>, a spool assembly <NUM>, leaf springs <NUM>, and release arm <NUM>. Tensioner <NUM> may be a ratcheting tensioner with adjustable head <NUM> configured to move between two different positions, as explained in further detail below.

Referring to <FIG> and <FIG>, each handle assembly <NUM>, <NUM> has a thru hole to accept the spool assembly <NUM>. The first and second handle assembly are so configured that the thru hole are coaxial defining a single hole in which the spool assembly is inserted. Tensioner <NUM> has two ratchets <NUM> that are disposed between fixed handle <NUM> and pivoting handle <NUM> on either side of fixed handle <NUM> (see <FIG>). Each ratchet <NUM> has cutouts to accept the two halves of spool assembly <NUM>. Spool assembly <NUM> is able to rotate freely within the handle assemblies <NUM>, <NUM>, but is keyed to ratchets <NUM> such that spool assembly <NUM> rotates when ratchets <NUM> rotate. The space between the two halves of spool assembly <NUM> is large enough to accept a flexible band, such as flexible band <NUM> shown in <FIG>.

As shown in <FIG>, pivoting handle <NUM> has a bore <NUM> to accept an actuator <NUM> and an actuator spring <NUM>. Actuator spring <NUM> forces actuator <NUM> to contact one of ratchets <NUM> in a resting position. In other words, the actuator spring <NUM> is so configured that in its rest position forces the actuator <NUM> to contact one of ratchets <NUM>. Pivoting handle assembly <NUM> has two thru holes to accept an actuator button <NUM> and the button pin <NUM>. Actuator button <NUM> is coupled to actuator <NUM> with actuator pin <NUM> such that when button <NUM> is depressed, actuator <NUM> translates away from one of ratchets <NUM>, disengaging the two pieces. The actuator <NUM> is slidable into the bore <NUM> so that it could be moved away from/close to the ratchet <NUM>. The bore <NUM> is preferably defined in a portion of the pivoting handle <NUM> adjacent to the thru hole and thus close to the spool assembly <NUM>. The actuator button <NUM> emerges from the thru hole so as to be operated by an operator to move the actuator <NUM>.

Fixed handle assembly <NUM> is coupled to release arm <NUM>. Release arm <NUM> is positioned within a slot and is secured by a pin. Release arm <NUM> has a counter bore to accept a release spring <NUM>. Release spring <NUM> forces release arm <NUM> into contact with one of ratchets <NUM> at rest. Release arm <NUM> can be disengaged from one of the ratchets <NUM> by depressing release arm <NUM>, compressing release spring <NUM>.

Release arm is preferably provided on external portion of the fixed handle assembly <NUM>, i.e. opposite to the pivoting handle <NUM> so as to be accessible for a user. Preferably, release arm is arranged close to the spool assembly.

Tensioner <NUM> has leaf springs <NUM> coupled to handle assemblies <NUM>, <NUM>. Leaf springs <NUM> cause handle assemblies <NUM>, <NUM> to remain open at rest.

When handle assemblies <NUM>, <NUM> are squeezed, actuator <NUM> on pivoting handle assembly <NUM> contacts one of the ratchets <NUM> and forces ratchets <NUM> and spool assembly <NUM> to rotate. While ratchets <NUM> are rotating, release arm <NUM> on fixed handle assembly <NUM> is lifted into consecutive ratchet positions. When the handle assemblies <NUM>, <NUM> are released, leaf springs <NUM> cause handle assemblies <NUM>, <NUM> to open and actuator <NUM> on pivoting handle assembly <NUM> lifts back into consecutive ratchet positions. Spool assembly <NUM> is held in the new orientation and does not rotate back with the opening pivoting handle assembly <NUM> because release arm <NUM> on fixed handle assembly <NUM> is engaged with one of the ratchets <NUM>. This process is repeated causing spool assembly <NUM> to rotate within tensioner <NUM>.

Adjustable head <NUM> is connected to fixed handle assembly <NUM> via a button assembly <NUM>. Button assembly <NUM> allows adjustable head <NUM> to be positioned in two orientations with respect fixed handle assembly <NUM> as shown in <FIG>. As shown in <FIG>, adjustable head <NUM> has a key feature <NUM> which mates with a locking washer <NUM>. Locking washer <NUM> can engage key feature <NUM> in two orientations. Locking washer <NUM> is positioned inside a housing on fixed handle assembly <NUM>. A wave spring <NUM> is positioned between the housing of the fixed handle assembly <NUM> and locking washer <NUM> to force locking washer <NUM> into contact with key feature <NUM> on adjustable head <NUM>. Adjustable head <NUM> has a slot to accept the feet of button <NUM>. The button feet are able to flex into the slot and spring back causing button <NUM> to be retained on adjustable head <NUM>. The length of the button feet are of sufficient length to push locking washer <NUM> out of engagement with key feature <NUM> on adjustable head <NUM> when button <NUM> is pressed as shown in <FIG>. Therefore, adjustable head <NUM> may be moved between the two positions by pressing button <NUM>. Adjustable head <NUM> is coupled to fixed handle assembly <NUM> via a screw through button assembly <NUM>. Preferably, the button is pushed the operator moves the adjustable head <NUM> positioning it in the desired position.

<FIG> and <FIG> illustrate tensioner <NUM> and a band clamp inserter assembly <NUM> according exemplary embodiments consistent with the present disclosure. Adjustable head <NUM> has a slot <NUM> to accept a handle attachment <NUM> of band clamp inserter assembly <NUM>. Band clamp inserter may be of the embodiments previously described in this disclosure. Intersecting slot <NUM> is a bore to accept a button spring <NUM> and stop pin <NUM>, as shown in <FIG> and <FIG>. At rest, button spring <NUM> causes stop pin <NUM> to protrude into slot <NUM> which accepts handle attachment <NUM>. Fixed handle assembly <NUM> has two thru holes to accept a button <NUM> and a button pin <NUM>. Button <NUM> is coupled to stop pin <NUM> with button pin <NUM> such that stop pin <NUM> translates into fixed handle assembly <NUM> when button <NUM> is depressed. Therefore, adjustable head <NUM> can be engaged onto handle attachment <NUM> when button <NUM> is pressed. When button <NUM> is released, stop pin <NUM> translates into a mating hole <NUM> on handle attachment <NUM> to securely couple the tensioner <NUM> to band clamp inserter assembly <NUM>.

After flexible band <NUM> is fed thru the band clamp and the band clamp is placed onto a rod with band clamp inserter assembly <NUM>, tensioner <NUM> is engaged with band clamp inserter assembly as shown in <FIG>. In <FIG>, flexible band <NUM> is then inserted up through tensioner <NUM> between the two halves of spool assembly <NUM>. Handles <NUM>, <NUM> of tensioner <NUM> are then actuated, for example in a ratcheting manner, in order to wrap flexible band <NUM> around spool assembly <NUM>, thereby pulling flexible band <NUM> through the band clamp and applying tension as shown in <FIG>. Once a sufficient amount of tension is achieved, a driver shaft may be passed through band clamp inserter assembly <NUM> and into a set screw on the band clamp to lock the tension in flexible band <NUM>. Tension may be removed from flexible band <NUM> by unwinding spool assembly <NUM>. In order to do this, release arm <NUM> and actuation button <NUM> on tensioner <NUM> are depressed simultaneously to disengage ratchets <NUM> and spool assembly <NUM> is rotated manually to release tension in flexible band <NUM>.

The present disclosure offers a surgeon the ability to orient tensioner <NUM> in two different positions depending on preference of hand position during tensioning of flexible band <NUM>. <FIG> shows a system <NUM> having two sets of tensioners in different position. Band clamps are often used at consecutive spinal levels and anatomy oftentimes dictates that the band clamps be positioned close to one another. Therefore, it is advantageous for the surgeon to be able to have two handle positions in order to give space for the surgeon's hands.

The present disclosure allows surgeons to tension a flexible band in order to correct spinal deformities and achieve fixation. The instrument described above offers easy engagement with the band clamps and flexible bands, which will save time compared to existing art that use secondary locking steps for the band clamps or flexible bands. This present disclosure allows options in tensioning capacity, which is an improvement over existing art which is limited by the travel range of threaded mechanisms. This saves the surgeon time during surgery as the tensioner would not need to be reset during correction. In addition, the handle mechanisms allow for ease of use without the need for additional actuating instruments. The adjustable orientations will allow the surgeon to customize the implementation of instruments to the patient in order to optimize visualization of the surgical site.

Claim 1:
A system for applying tension (<NUM>) to a flexible band (<NUM>) during a spinal fixation surgery, comprising:
- a first handle assembly (<NUM>);
- a second handle assembly (<NUM>)
- a spool assembly (<NUM>) disposed between the first handle assembly (<NUM>) and the second handle assembly (<NUM>), the spool assembly (<NUM>) configured to receive the flexible band; wherein
- the second handle assembly (<NUM>) is configured to pivot relative to the first handle assembly (<NUM>);
characterized in that the system further comprises
- an adjustable head (<NUM>) movably fixated to the first handle assembly (<NUM>), wherein the adjustable head (<NUM>) is configured to be adjusted in two angled orientations with respect to the first handle assembly (<NUM>) within the plane of the first handle assembly (<NUM>) and the second handle assembly (<NUM>).