WO2016044843A1

WO2016044843A1 - Fusion systems and methods of assembly and use

Info

Publication number: WO2016044843A1
Application number: PCT/US2015/051251
Authority: WO
Inventors: Jill A. SERBOUSEK; Jeffrey Nycz; Jon C. Serbousek
Original assignee: In Queue Innovations, Llc
Priority date: 2014-09-19
Filing date: 2015-09-21
Publication date: 2016-03-24
Also published as: US20220257287A1; US11317948B2; EP3193755A1; EP3193755A4; EP3193755B1; AU2015317306A1; US20170189070A1; AU2015317306B2; US10368914B2; US20190357942A1

Abstract

The present invention discloses fusion systems and methods of assembly and use. The fusion systems include a first fastener, a second fastener, and an elongate member with a first end and a second end. The first end being secured to the first fastener and the second end being secure to the second fastener. The method of assembling a fusion system and methods of using the fusion systems are also disclosed.

Description

FUSION SYSTEMS AND METHODS OF ASSEMBLY AND USE

CROSS REFERENCE TO RELATED APPLICATION

This ap licative claims priority benefit ttadex 35 U,S,C, § 119(e) of U .S. ov sio al application No. 62/052,915 filed September 19, 2014, which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

he present invention relates generally to general surgery, orthopedic atsd neurosurgical implants tssed for nsertion wk a patient ^*s bones. More specifically, ^'but not exclusively, die resent Invendots concerns fnsiou and/or fixation systems for implantation into a. patient's bones to maintain or re-establish proper spacing and alignment between or within the bones.

BACKGROUND OF TEE INVENTION

Spinal deformities a result f om disease, age, imrnm causing destahifeatiort of the spine. To correct destabllr¾aiio» of a pattern's spine, posterior fes!oa device systems may he sed. The posterior fusion devise systems hat: are anr ntly a aila l are desired to be applicable to single and multi le level stabilisations. Cu re tly used pedicle or polya?dal scre t& a top down locking mechanism, that may allow r¾r rod loose ing- and/or micro moti n between the screws due to improper rod seating which may extend the time to achieve hssicjrs or lead to uoji-frtslon. The rod micro motion may be created by the use of a t hrough slot In t he screw 0 position t e rod td the lack of a physical constrain ort the end of the rod which is captured within the screw Stea locking mechaulsnt. These fusion device systems and die instr imeutation used for insertion into a stien s spine- are extensive., complicated, a id expensive.. Ftniner,, additional bones in a atient's body may be t¼ctured or othe se damaged Item disease, age or trauoi and may eunite systems to maintain or re-establish proper ali nment and positionmg. Therefote, improved fusion and/or fixation device systems and ffistr imentat to?) are needed.

SUMMARY OF THE INVENTION

Aspects of the present invention provide fusion and/or featiou systems and methods that can nsaintaiu or re-establisb anatomic s acing withi patten s bones, for example, a patient 's spine or one f victnre location.

.In o e as ect, provided here is a fesl tr system, including a first one piece screw, a second one piece screw, and a rod cou led to the first one piece screw at a first end and the second one piece scre a second end, wherein the rod may be positioned at varying angulations with respect to the first and second one piece screws.

la another aspect, provided er in is a fnsion system, including a first fastener, a. econd fastener, md m elongate member with .first end d a second end, wherein the first eud is 5 secured ro- the first fcten a d d¾ second e¾d is seewed to the second fastener,

in a fort e r aspect_* provided, herein is a method fo imetnhihtg a fusion system including; obtaining fe tower, a second t0wer_s a first fastener, a jsecond fastener, and. an elongate member; conpling the fi st fastener to the first tower coupling the second f stener to the second tower; Inserting a first end of the elongate nte- lier into the first fastener; inserting a second, end

^'ϊβ o the. efougate member into the second fastener; conn-ling a f t locking cap to a screwdriver; screwin the first locking cap into a head of the first fastener to secure tie firs t end of the elongate member to the first fastener; coupling a second locking cap to a screwdriver; and screwing the second locking cap Into a head of the second fastener to secure the second end of the elongate member to. the second fastener.

15 in yet another aspect, provided herein is a surgical method for inserting a i¾sio.u system,

Including exposing a patient's vertebrae and obtaining the fusion system. The method may also include inserting « first fastener into s fi t vertebr md inserting .a second fastener into a second vertebra adjacent to th first verteh ir i%riher, the method ma include coupling the first fastener and second festensr,

20 These, and other objects, featur e and ad vantages of this invention wil t become apparent im the following detailed description of d e various aspects of the invention taken in conjunction w th the ¾ &oia gny ng drawings,.

BRIEF DESCRIPTION OF DRA WINGS

The accompanying drawings, which are incorporated hi and constitute a par of the 25 specification, i!lustrate entodlments of the invention and together with the d taile description herein, serve to x l in the principles of th Invention, The drawings are only for purposes of illustrating preferred m o iments and are not to foe construed as limiting the invention, it is em h sise that, In accordance with the standard practice In the industry, various features e not drawn to scale. In fact, the dimensions of the various features ma be arbitrarily increased or 30 reduced for clarity of discussion.

FIG, I is perspective view of a bottom of set .screw and the base of a fastener of a fusion systeni, in accordance with an aspect of the present invention

₉ IG, 2 is a side view of a cross section of a set screw and the base of a -fastener of a f isiofi system, in accordance w th m aspect of fee present invention:

FIG. 3 i a perspective view of a elongate member for a fusion system, in accoidaiice with m aspect oft.be present invention;

FIG 4 is a partially exploded perspective view of a fusion system, in accordance with an aspect of the present invention;

FIG_* S s a partially exploded -perspective view of another embodiment of .a fusion system, in accordance with an aspect of the present invention;

FIG_* -6 is a cross-section of a fastene of the fusion system of FIG. 5 taken along line 6~~ 6, in ccord nce with an aspect of fe present invention;

FIG, 7 is a perspective transparent view of an insertion tower, in accordance with an aspect of tire present invention;

FI 8 is a side trans ren view of the insertion tower of FIG, 7, in accordance with an aspec of tfce present invention;

FIG.9 is -a front perspective. transparent view of the insertion tower of FIG. 8, in accordance whit an aspect of the present inv ention:;

FIG, 1Θ is an exploded, perspective vie of a screwdriver, in accordance with an aspect of the present Invention;

FIG, 11 is an assembled, perspective view of the screwdriver of PIG . 10, in accordance with an aspect of the present invention;

FIG, 12 is a side view of the screwdriver of FIG. 1 l _s In accordance with an aspect of the present invention;

FIG 13 is a first end view¹ of the screwdriver of FIG. 12, in accordance with an aspect of the present in ention;

RIG, 14 is a partial, cross-sectiona! view of a fastener of the fusion system of FIG, 5 coupled to the insertion tower of FIG, 7, in accordance with an aspect of the present invention; FIG. 15 is a cross-sectional view of a portion of the assembled fusion system of FIG. 5, In accordance wil m aspect of di e prese invention

FIG. 16 is atop view of a fastener of the fusion system of FIG. 5, in accordance with an aspect of {fee present i vention;

S FIG 1? is a side cress -sectional vi w of a portion of fastener of the fusion systems of

FIG. 5 taken along line 17—7 in FIG. 16, in accordance with an aspect of the present invention;

FIG, 18 is a side view th assembled fusion system of FIG. 5 in a first position, in accordance with an aspect of the present invention;

FIG 19 is a to view of the assembled fesion system of FIG, 5 in a second position, in 10 accordance with an aspect of the present invention; IG_* 28 is a stile view of th assembled fusion system of FIG, S in third position, is accordance with n aspect of the re en invention; and

FIG_* 21 is side view of die usion system of FIG,.5 in a fourth position, in accordance with an aspect of the present invention..

S 5 RETAILED DESCRIPTION FOR CARRYING OUT TBE INVENTION

Generall stated, disclosed herein are fusion aiid r feation ystem . Further, methods, of assemblin ie fusion ¾»d br f&¾ti©» systems and surgical methods for insetting the fusion and/or ixat o systems re discus ed,

in tins detailed escrtptJoP and the following A ms, t words proximal, 4im a edoi ,

^'20 posterior, medial, lateral, superior, inferior, eephalad and candally are defined by their standard ■usage for indicating a parficwtar part of a bone or implant according o: the relative disposition of the natural bone or directional terms of reference, f½r example, "proximal" meatss the portion of an impkiii nearest the h Cf fe i tru e t while ^{^}dist l⁵⁵ indie c the portion of the implant farthest from the lasertiori Insimsent, As for directional ternm, "anterior* is a direction towards

25 the if ©in side of the body, "posterior" means a direction towards the back side of the body,

"med!af ' me ns towards tin? midline of the body, "lateraf ' is a direction towards the sides or away from the midline of the body, "superior means a direction above and "inferior" means a direction below another object or structure, "ee aM^* &m a direction toward the bead md "caudaSly" means a direction toward the inferior part of the body.

Mi Refemag « to HGS. 1 , 2 and 5, set screw 400 is shown. The set screw or locking cap 400 may include a top surface 404 and a bottom surface 406. The top surface 406 may include, an o en ng 403 for receiving a screwdriver. The o¾om surface 6 may include- a recess 40S;, The recess 408 tmy Include a ra ius RT as shown in ¥JQ. 15_S and described in greater detail below.. Use set screw 09 nray also include threads 410 on the ext rior surface of the set screw 400 between the top .surface 404 «d the bottom, surf ce 406. For example, She set screw 400 rosy be «.s¾il with iosgaie inembers 550, «530 which each include ball ends 552, 554, 6S2, 65 that wotrfd e ecei ed withh the recess 408 on die bottom surface 406 of the set scre s 400.,

FIG, 3 shows an erobediroent of an elongate mem er 2 0. The elongate mem er 2 0 includes a first ead 292 and a second end 294, The first eii 292 lias a re tangular shape which angles at a tapered portion 29S to the second en 294 which is a bah ei¾d 298, The second end 294 may have a d aroeier larger jthat*. he diameter- of the lapered portion 296 and the body of the rod. The elongate mem er 290 may be -used with, for example, a first fastener assem ly 51 to receive the first end 292 sad a second ikrteser 530 to receive the second end 294 or vice versa, as described in gfeaier detail below.

As 'sho n in ΨΪΟ-, 4, a fusion and/or fixation system 500 may include a first fastener 510, a second f¾teoer 53(1 and an elongated fterober 550. The first fas ener 510 may include a shaft 512, . a head 5 !4„ and a ck 516 connecting the shaft 51 and hear! 51.4, The shaft 512 may be threaded, for example, along its entire length or ^'iotig only a portion of the lefigth or

aSternatlveiv, the shaft 512 may be ftoft-ihr a eds 1¼ head S 14 Oiay include a first m 18, a seco d am? 520, and a passageway 522 extending between the tlrst arm 518 and ihe second arm 520. The .& i arm 518 and second ami 520 each have an interior surface .formed ^'by the passageway 522_:. The ssage ay 522 creates o openings se aratin the first ar 1.8 and the second rm 520.. The openings of ihe passageway 522 are si¾ed to allow a center portion 556 of the elongate member 550 or the first end 292 of the el ongate membe 290 to pass through the openings, bat not. the hail ends 294, 552, 554 of the elongate members 290, 550, respectively. The passageway 522 also forms a base 5.24 near the bottom of the head 514, The base 524 nmy be, lot example, plana? m Illustrated, alteritattvely, the base- 52 m&y be curved or arced to correspond to i shape o f the first end 552 of the rod 550.. For example, the base 524 ma be concave. The first arm 518 and the second am 520 ma each be cu ved to form a ro tnded passageway 522 for receiving the rod 550. n addition, tbe first srni SIS and the second a m 520 may have, for exam le* a threaded portion 52b that e tends along at least; a portion of the i terior surface of each of the first and second m 18, 520 from a top surface of the bead 51 toward the base 524, The threaded portion 52b may receive a. !ocfcmg mechanism (not shown^'), such as, set screw 400, to secure the elongate member 550 to the- tlrst fastener 51.0, The locking mechanism (not shown) may have a bottom surface that is dimensioned to couple to the rounded end 552 of the elongate membe 55 . Thus, the bottom sur&ce of the tockmg taecliaitism may be, f r exam le, concave. Alternatively, the locking mechanism m y be_r, for example, a press fir ineehaoisirs to secure the elongate member 550 to the heads 5Ϊ4, 534 of the fastener 510, 530.

W th continued refe ence to IT 4, the second fastener 530.m focfode a shaft 532_* a he-ad S34., - && neck 36. c nn cting the shaft 532 d head 534, The shaft 532 nnry be thre ded, fbr ex m le, along Its satire length or aJoi g only a por ioo of the length, or

alternatively, the shaft 532 stay e non^hreaded. The hear! 534 may include ¾ first mm 53S_S ¾ second aim S40, nd a passageway 542 extending between the first ami 53 S and the second arm 540, The first arm 538 and the seeosd ¾mt 540 each h v m s^rlor smfoee fomted by the passageway 542, The passageway 542 also forms a base 544 near the bottom of the head 534, The base 544 may he, for -esaflipfe, planar as illustrated, alternatively, the base 54 may be carved or arced to correspond to the renaded shape of the rod 5 0, The first am* 538 and the secomf arm 540 ma each be carved to form a rounded passageway 542 for receiving the rod 550, hi a dit on the first arm. 53$ mi the second arm 540 m have,, for exam le., a threaded portion 546 thai extends, along at leasf a portion of the mterfer surfac of each of foe first and second arms 53fo 540 ft a top surface o ihe head 534 toward the base 544, The threaded portion 546 may receive a locking mechanism (not shown) to secure the elongate member 550 to foe second fastener 53 :, for ex m e set scr w 400,, The locking chanis {nor shown) m y h v hottotn surface that i dimensioned to eo ple to the roonded end 554 of the elongate member $50. Tfurs, the bottom snrface of the lock ng mechanism may he, for example, concave.

The elongate embe 550_s as shown in IG. 4, may include a first end 552„ a seeded end 554, and a center portion 5 extending betwee the first end 552 and secon end 554, The first end 552 and second end 554 may he ro nded to correspond to the rcnmdetl passageways 522, 542 of foe first and secorjd fasteners 510, 30, respectively. The -center portion 556 may be, for example., smaller than foe first end 552 ami he second end 554, For example, the center portion 556 may have a width that is smaller than the dameter of foe first md second, ends 552, 554. The- elongate member 550 may also include a first tape ed portion 55 coupling the center portion 5 6 to the first e»d 552 and a second tapered portion 560 coupli g the eemer portion 556 to the second end 5.54. The first tapered portion 55S and the second tapered portion 560 may have a smaller dimms n than the first era! 552 mud second end 554, respectively.

Another ftsion and/or fixation system 600 is shown in IG. 5 and may i clude a first fasteficr 61.0., a second fastener 630, an. elongate number 650., and two locking members or ca s 400, As shown in F GS.. S~6 the first -fast n r 610 ma include a shall 612, a head 614, and a neck 616 connecting foe shaft. 612 arid head 61 , ^"The shaft 61 may be threaded, fbr exam le, along its entire length or along only a portion of the length, alternatively, the shaft 612 ma also be non-threaded. As depicted in FIGS. 5 and 6. the shaft 612 may include varying thread configurations along the shaft 612 length, for example, the shaft 612 may include a single lead thread 61 1 ai the distal end of the shaft 612 and a dual lead thread 613 at the proximal end of the shaft 612. The dual lead thread 613 provides increased bone contact within the cortical margin to increase fastener 610 stability. The dual lead thread 6 i 3 may extend into the tapered neck 616 of the fastener 61Q to provide additional conical bone purchase and allow for potential bone ingrowth into the thread form for increased fixation. The shaft 612 may also include a leading tip 615. The leading up 615 may include, for example, a sharp cutting edge to assist with inserting the fastener 610 into the bone, which may eliminate the need for tapping into the bone pi iot to implantation of the fastener 610.

With continued reference to FIGS. 5 and 6, the head 614 may include a body 618 with an opening or slot 620 extending into the body 618 from the top of the head 614 and a portion of the body 618. The body 618 may be curved and may extend, lor example, ctrcumferenitally greater than 180° and less than 345'' leaving an opening 620 of. for example, greater than 15° and less than 180°. and more preferably may be curved and may extend, for example.

circumferentially approximately 270° leaving an opening 620 of. for example, approximately 90°. The opening 620 may extend from the lop surface of the head 614 down to a position below the midline of the head 620 The body 618 only, including one opening 620 provides additional support for the rod 650 to prevent longitudinal movement of the rod 650 after insertion into the patient. The opening 620 is shaped to provide for rod translation in both rite axial plane, i e. up and down direction, and the rotational plane, i.e. left and right direction. The opening 620 may also be shaped to allow for rotation of the head 614 of rite fastener 610 about the multi-axis of the first end 652 or me rod 650. In one embodiment, as shown m FIGS 16 and 17. the opening 620 allows for. for example, an angle γ of rod positioning in the axial plane and an included angle α, β of rod positioning in the rotational plane. For example, γ may range from approximately 5° to 75° and more preferably from approximately 20° to 40°. a may range from approximately 1° to 70° and more preferably from approximately 5° to 15°, and β may range from approximately 1° to 70° and more preferably from approximately 5° to 15°. In one embodiment, for example, γ may be approximately 34°, α may be approximately 10°, and β may be approximately 10°. The opening 620 allows for rod angulation and/or positioning that provides for anatomic variability of the rod 650 when inserted into the fastener 610. white capturing the ball end 652 to maintain the distance between the first fastener 610 and the second fastener 630 The anatomic variability enables the rod 650 to be implanted into a patient at an angle when desirable for correction. The thickness of the rod 650 may also be altered to provide for a larger or smaller angle for the desired correction. The body 618 may have an interior surface formed by the opening 620.

The opening 620 also forms a base 622 near the bottom of the head 614, as shown in FIGS. 5 and 6. The base 622 may be, for example, curved or arced to match the shape of the first end 652 of the tod 650 as illustrated, alternatively the haste 622 may be planar. The body 618 may be curved to receive the rounded end of the rod 650. In addition, the body 618 may have, for example, a threaded portion 624 that extends along at least a portion of the interior surface of the body 618 from a top surface of the head 614 towards the base 622. The threaded portion 624 may receive a locking mechanism to secure the elongate member 650 to the first fastener 610. such as. set screw or locking cap 400 The locking mechanism 400 may have a recess 408 that is shaped to receive the rounded end 652 of the elongate member 650. For example, the recess 408 of the set screw 400 may be dimensioned to be smaller than the first end 652 of the elongate member 650. Thus, the bottom surface of the locking mechanism may be, for example, concave The head 614 may also include a ridge 670 extending around the exterior surface of the head 614. The head 614 may further include a first tab 672 and a second lab 674 on the exterior surface of the head 614 and positioned between the top of the fastener 610 and the ridge 670.

As shown in FIG. 5, the second fastener 630 may be of the type described above with reference to first fastener 610. The second fastener 630 may include a shaft 632, a head 634 with a body 638, an opening 640. a base (not shown) and a threaded portion 644. and a neck 636 extending between the bead 634 and shaft 632, which may be of the type described above with reference to the shaft 612. bead 614 with the body 618. an opening 620, a base 622 and a threaded portion 624, and a neck 616 which will not be described again here for brevity sake. A locking mechanism, such as, set screw 400, may also be used with the second fastener 630 for insertion into the head 634 to engage the threaded portion 644. The locking mechanism 400 may he used to secure the elongate member 650 to the second fastener 630. The locking mechanism 400 may include a recess 408 that is shaped to correspond to the rounded end 654 of the elongate member 650. The recess 408 in the locking mechanism 400 may have a curvature dimensioned to be smaller than the curvature of the rounded end 654 to secure the rounded end 654 in the head 634 of the fastener 630. Alternatively, the locking mechanism may be. for example, a press fit mechanism to secure the elongate member 650 to the heads 614, 634 of the fasteners 610.630. Once both locking mechanisms 400 ate secured in the fasteners 610, 630. the distance between the fasteners 610. 630 is secured.

The elongate member or rod 650. as shown in FIG 5, may include a first end 652. a second end 654, and a shaft portion 656 extending between the first end 652 and second end 654. The fust end 652 and second end 654 may be rounded or ball ends with shapes to correspond to the rounded openings 620, 640 of the first and second fasteners 610, 630, respectively The ball ends 652.654 may be sized such that they have a diameter larger than the diameter of the shaft portion 656. as well as. the recess 408 of the set screw 400 and the base 622 of the fasteners 610, 630. as shown in FIG. 15. The ball ends 6S2. 654 may have, for example, highly roughened or textured surfaces. The textured surfaces of the ball ends 652. 654 may assist with securing the elongate member 650 between the fasteners 610. 630 and the net screws 400. lite roughened or textured surface may be of the type to allow for deformation of the roughened or textured surface when the set screw 400 is tightened into the head 614.634 of the fastener 610. 630. The elongate member 650 may also include a first connection portion 658 coupling the center portion 656 to the first end 652 and a second connection portion 660 coupling the center portion 656 to the second end 654.

The fasteners 510. 530.610. and 630 may be cannulated through the center of the shaft along a longitudinal axis of the fasteners 510. 530.610, and 630 and include an opening, for example, opening 626 of fastener 610, as shown in FIG. 6. to enable insertion over a guide wire, k-wire, pin, or the like to assist with insertion into the patient. As shown in FIC. 6, the base 622 of the fastener 610 may include a screw engagement portion 628 positioned at the top of the opening 626. The screw engagement portion 628 may be shaped to correspond to the screwdriver instrument, such as screwdriver 800 described in greater detail below, for insertion of the fasteners 510, 530, 610, 630. The screw engagement portion 628 may have, for example, a female cyiindrical. hexagon, or other polygonal shape.

A system for inserting the device 600 may include an insertion tower or tube 700. as shown in FIGS. 7-9, a screwdriver 800, as shown in FIGS. 10* 13. and two fastener systems 610, 630. The insertion tower 700 may lurve a body 702 with a first end 704 and a second end 706. lite body 702 may have a central opening 708 through the center of the body 702 along the longitudinal axis. The body 702 may also include a cutout 710 at the first end 704 of the body 702 extending from an exterior surface to an interior surface of the body 702. The body 702 may further include a channel 712 extending from the second end 706 of the body 702 toward the first end 704 and an opening 714 positioned opposite the channel 712. The channel 712 and opening 714 each extend from the exterior surface to the interior surface of body 702 allowing for insertion of a rod 290. 550, 650. The body 702 may also include a first slot 716 extending from the second end 706 of the body 702 to an opening 718 which may be, for example, a round opening, and a second slot 720 extending from a second end 706 of the body 702 to an opening 722 which may be. for example, a round opening. The slots 716, 720 may be positioned between the channel 712 and the opening 714 at the second end 706 of the body 702. Although only two slots 716. 720 are shown, it is also contemplated that additional slots may be included in the tube 700 to allow for expansion of the tube 700 when a fastener 610.630 is inserted or removed from the tube 700. The interior side of the body 702 may include a groove 724 positioned at the second end 706. The groove 724 may be sized to receive the ridge 670 on the exterior surface of the fasteners 610.630.

Referring now to FIG. 14, a cross-section of the fastener 610 is shown inserted into an insertion tube 700.. To insert the fastener 610 into the tube 700. the first tab 672 may be aligned with the second slot 720 and the second tab 674 may be aligned with the first slot 716. In addition, the opening 620.640 of the fastener 610.630 may be aligned with the channel 712 of the tower 700. As the tabs 672. 674 are inserted into the slots 7 to, 720. the tube 700 will expand to allow the head 614 to be inserted into the central opening 708. The bead 614 may be insetted into the central opening 708 until the ridge 670 of the head engages the groove 724 to secure the fastener 610 to the tube 700. To enable the fastener 610 to be secured to the tube 700, the inner diameter of the tube 700 may be, for example, the same dimension as the outer diameter of the head 614 of the fastener 610.

FIGS. 10-13 show the screwdriver 800 which is shaped to engage the fasteners 610.630 for insertion into a patient. In addition, the screwdriver 800 is sized to be used with the tube 700 and able to be inserted through the central opening 708 of the tube 700. The screwdriver 800 may include a handle portion 810 at a first end 802 of the screwdriver 800 and a shaft portion 820 extending from the handle portion 810 to the second end 804. The handle portion 810 may be positioned generally perpendicular to the shaft portion 820 The handle portion 810 may include a body 812 and an opening 814 for receiving one end of the shaft portion 820. The shaft portion 820 may include a shaft 822 with a screw member 824 at the second end 804 of the screwdriver 800. The screw member 824 may be sized for engaging the opening 628, as shown in FIGS. 6 and 14. of fasteners 610.630. In addition, the screw member 824 may be sued and shaped to also engage an opening 403 in the set screw 400 to securely tighten the set screw 400 against the rod 650. The screw member 824 may have, for example, a torque, hexagon or any other polygonal shape. The second end 804 of the screwdriver 800 may also include a tab or protrusion 826 for engaging the opening 620 in the fastener 610 to drive the fasteners 610, 630 into a patient's bone. The screwdriver 800 may further include a cannulated opening 828 for receiving a guide wire. The cannulated opening 828 may extend along the shaft 822 to a slot (not shown) in the handle portion 810 which allows the guide wire to be turned into the body 812 of the handle portion 810 to avoid piercing the surgeons gloves.

Referring now to FIG. 15. a portion of the fusion system 600 including the fastener 610, rod 650, and locking cap 400 are shown as partially assembled. To reduce and/or eliminate the incident of axial and rotational motion the radii of the fastener 610, rod 650. and locking cap 400 have been selected to provide a locking fit between the fastener 610. rod 650. and locking cap 400. The rounded end 652 of the rod 650 has a curvature indicated by R 1 The base 622 of the head 614 of fastener 610 has a curvature indicated by R2. The recess 408 of the locking cap 400 has a curvature indicated by R3. In one embodiment, for example, the curvature of R 1 will be greater than or equal to the curvature of R2 to form an interference tit between the fastener 610 and the rod 650 once secured with the locking cap 400. As described in greater detail abovv. the ball ends 652. 654 of the rod 650 may have a surface finish that is. for example, rough, nearly knurled, or .smooth, to allow for the surface of the ball ends 652. 654 to deform and securely retain the rod 650 within the head 614 of the fastener 610. Further, the curvature R3 of the locking cap 400 may be less than or equal to the curvature of R 1 of the rod 650. Where R3 is less than or equal to R 1 , the locking cap 400 will make contact with the rod 650 near the point where the bottom surface 406 meets the recess 408 and the rod 650 will not make contact with the apex of the recess 408. Therefore, when R3 is less than or equal to R 1. there will be a non- contact area gap between the ball end 652 of the rod 650 and the recess 408 of the locking cap 400 to reduce or eliminate the rod 650 from slipping

Referring now to FIGS. 18-21. the rod 650 is shown inserted into listeners 610, 630. In FIG 18. the rod 650 is positioned angled between the first fastener 610 and the second fastener 630 inserted at varying heights. The second fastener 630 may be positioned, for example, at a greater height than the first fastener 610. Further, FIG. 19. shows the rod 650 positioned angled with respect to the first and second fasteners 610, 630 with the first fastener 610 offset from the second fastener 630. The rod 650 may be positioned angled between the first fastener 610 and second fastener 630 and may be positioned with the first fastener 610 located, for example, at a height greater than the second fastener 630. as shown in FIG. 20. In addition. FIG. 21 shows the first and second fasteners 610. 630 rotated about the long axis of the rod 650 und offset from each other. Once the rod 650 is inserted into the fasteners 610, 630. the load is in compression, tension, or neutral. The load on the rod 650 is perpendicular to the axis of the fasteners 610. 630. As illustrated by FIGS. 18-21, me fasteners 610.630 are configured to accommodate multi-axial positioning with respect to the rod 650.

A first method for inserting the devices 500, 600 of FIGS 4-5 info a patient may include cutting a small incision in the patient, for example, a 3 cm incision Next the fascia is cut and muscles are split in line of the fibers to expose the patient's vertebrae. Once the vertebrae are exposed, an image guidance or fluoroscopy device may be used to insert a first fastener or pedicle screw 510, 610 into a fust pedicle of a first vertebra and a second fastener or pedicle screw 530, 630 into an adjacent second pedicle of a second vertebra 530, 630 may be inserted using a guide wire if the fasteners 510.610, 530.630 are cannulaied or free hand. Then the elongate members 550, 650 may be lowered into the heads 514, 614. 534, 634 of the fasteners 510, 610. 530, 630. respectively. An elongate member 550, 650 that is shorter than the in situ distance between heads 514.614 and beads 534, 634 may be used for compression of the engaged vertebrae. While an elongate member 550, 650 that is longer than the to situ distance between the heads 514. 614 and heads 534, 634 may be used for distraction of the engaged vertebrae. As the ball ends of the elongate member 550, 650 are inserted into the heads S 14. 534.614.634 the geometry of the ball ends align with the feature of the fasteners to either compress or distract the construct. Ax the bail ends are inserted into the heads 514. 534. 614, 634. the elongate member 550, 650 completes the compression or distraction of the bones. A locking mechanism, for example, set screws or kicking cap 400 may be inserted into the heads 514. 614. 534. 634 of the first and second fasteners 510, 610. 530, 630 and tightened down to secure the elongate members 550.650 to the fasteners 510.610. 530.630.

Alternatively, the second fastener 530.630 may be secured to the second end 554.654 of the elongate member 550, 650 prior to insertion of the second fastener 530, 630 into the second pedicle. Then after insertion of the coupled second fastener 530, 630 and elongate member 550. 650. the elongate member 550.650 may be lowered into the head 514.614 of the first fastener 510. 610. The first end 552. 652 of the elongate member 550. 650 is then secured to the first fastener 510.610. Optionally, additional intermediate fixation devices may be used between the end point fasteners 510, 530.610, 630. Finally, the patient's incision may be closed.

Another method for inserting the devices 600 of FIG. 5 into a patient may include cutting a small incision in the patient Next the fascia is cut and muscles are split in tine of the fibers to expose the patient's vertebrae, winch may be done using dilators. Once the vertebrae are exposed, an insertion system including a tower 700. a fastener 610, 630 and a screwdriver 800 may be assembled for insertion of each of the fasteners 610.630 into the patient's bone, as described in greater detail above. An image guidance or fluoroscopy device may be used to confirm proper positioning of a first fastener or pedicle screw 610 into a first pedicle of a first vertebra and a second fastener or pedicle screw 630 into an adjacent second pedicle of a second vertebra. The fasteners 610.630 may optionally be inserted using a guide wire since the fasteners 610.630 are cannulaied or free band Once the fasteners 610. 630 are inserted into the vertebrae, the elongate member 650 may be inserted into the heads 614, 634 of the fasteners 610. 630. respectively. An elongate member 650 that is shorter than the in situ distance between head 614 and head 634 may be used for compression of the engaged vertebrae. While an elongate member 650 that is longer than the in situ distance between the head 614 and head 634 may be used for distraction of the engaged vertebrae. As the elongate member 550, 650 is inserted into the beads 514, 534.614, 634 ihe force of inserting the elongate member 550.650 completes the correction of the bones. A locking mechanism, for example, set screws or locking caps 400 may be inserted into the heads 614. 634 of the first and second fasteners 610, 630 and tightened down to secure the elongate member 650 to the fasteners 610.630. Optionally, additional intermediate fixation devices may be used between the end point fasteners 610, 630. Finally, the patient's incision may be closed.

The elongate members 290. 550, and 650 may have a length. The length of the elongate members 290. 550. and 650 will be selected based on the procedure being performed and whether compression or distraction is desired. For example, a rod that is longer than the position of the in situ fasteners will be used for distraction to move the engaged vertebrae apatt and a rod tltat is shorter than the in situ position of the fasteners will be used for compression to pull the engaged vertebrae together. The length of elongate members 290. 550, and 650 may range from, for example, approximately 10 mm to 60 mm and more specifically approximately 20 mm to 50 mm. The elongate members 290, 550, and 650 may be straight or curved along the longitudinal axis.

The above described methods may be used for surgical procedures including, for example, lumbar, cervical, spinal trauma, pelvic fixation, fracture fixation, bone ends, and Ihe like.

As may be recognized by those of ordinary skill in the art based on the teachings herein. numerous changes and modifications may be made to the above-described and other

embodiments of the present invention without departing from the scope of the invention. The fasteners, elongate members, and other components of rite devices and/or systems as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the an to achieve the same, equivalent or similar results by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the devices and systems may include more or fewer components or features than the embodiments as described and illustrated herein. For example, the components and features of FIGS. 1 -6 may all be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Accordingly, this detailed description of the currently-preferred embodiments ts to be taken as illustrative, as opposed to limiting the invention.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a". "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood thai the terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has", and "having"), "include" (and any form of include, such as "includes" and "including"), and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a method or device that "comprises," "has." "includes." or "contains" one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that "comprises." "has." "includes." or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features Furthermore, a device or structure that is configured in a certain way b configured in at least that way. but may also be configured in ways that are not listed.

The invention has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to prov ide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.

Claims

CLAIMS Having thus described the preferred embodiments, the invention is now claimed to be:

1. A fusion system, comprising:

a first one piece screw;

a .second one piece screw; and

a rod inserted into the first one piece screw at a first end and the second one piece screw at a second end. wherein the rod may be positioned at varying angulations with respect to the first and second one piece screws.

2. The fusion system of claim 1. wherein once the rod is inserted into the first and second one piece screws there is no movement along the axis of the rod.

3. The fusion system of claim 1 , wherein the rod further comprises:

a mid-portion extending between the first end and the second end and wherein the first end and second end of the rod is larger than the mid-portion.

4. The fusion system of claim 3, wherein a diameter of the first end and a diameter of the second end are both larger than a diameter of the mid-portion.

5. A screw, comprising:

a body portion with only one rod opening extending from an exterior surface into an internal portion of the screw.

6. A fusion system, comprising:

a first fastener with a first slot:

a second fastener with a second slot; and

an elongate member with a shaft, a first end and a second end, wherein the first end is secured to the first fastener, the second end is secured to the second fastener, the first end and the second end have a diameter larger than the shaft, the diameter of the first end is larger than the first slot and the second end is larger than the second slot.

7. The system of claim 6. wherein the first slot extends from a top surface of the first fastener to a position below the mid-poim of the first fastener and the second slot extends Bom a top surface of the second fastener to a position below the mid-point of the second fastener.

8. The system of claim 6. further comprising:

a first kicking cap with a driver opening on a top surface and a recess on a bottom surface, wherein the first locking cap couples to the first fastener; and

a second kicking cap with a driver opening on a top surface and a recess on a bottom surface, wherein the second locking cap couples to the second fastener.

9. The system of claim 6, wherein the first fastener and second fastener each comprise:

a head;

a shaft and

a neck coupling the head to the shaft.

10. The system of claim 9, wherein the head comprises:

a body with a circumferential shape; and

an opening extending from a top surface of the head into the body.

11. The system of claim 10. wherein the head further comprises:

a ridge extending around the circumference of the exterior surface of the head: a first tab positioned on the exterior surface of the head and extending from the top surface of the head to the ridge: and

a second tab positioned on the exterior surface of the head, extending from the top surface of the head to the ridge, and spaced apart from the first tab.

12. The system of claim 6. further comprising:

an insertion tower for coupling to at least one of the first fastener and the second fastener; and

a screwdriver sized to engage at least one of the first fastener and the second fastener.

13. The system of claim 12. wherein the insertion tower comprises:

a body with a first end and a second end: a central opening extending through the body along a longitudinal axis from the first end to the second end:

a channel extending from the second end toward the first end and through the body to the central opening: and

at least one slot extending from the second end toward the first end and positioned spaced apart from and parallel to the channel.

14. The system of claim 13, wherein the at least one slot is two slots spaced circumfcrentially around the body of the insertion tower at the second end.

15. The system of claim 14, wlierein the insertion tower further comprises.

a groove inset into the body of the insertion tower at the second end and sized to receive a ridge on the exterior surface of at least one of the first fastener and the second fastener.

16. The system of claim 12, wherein the screwdriver comprises:

a handle portion: and

a shaft portion coupled to a central part of the handle portion, wherein the handle portion is perpendicular to the shaft portion.

17. The system of claim 16. wherein the shaft portion of the screwdriver comprises: a shaft with a first end and a second end;

a screw member positioned at the second end for engaging at least one of the first fastener and the second fastener:

a protrusion for engaging an opening in an exterior surface of a head of at least one of the first fastener and the second fastener.

18. A method of assembling a fusion system, comprising:

obtaining a first tower, a second tower, a first fastener, a second fastener, and an elongate member.

coupling the first fastener to the first tower:

coupling the second fastener to the second tower:

inserting a first end of the elongate member into the first fastener: inserting a second end of the elongate member into the second fastener:

coupling a first locking cap to a screwdriver; screwing the first locking cap into a head of the first fastener to secure the first end of the elongate member to the first fastener;

coupling a second locking cap to a screwdriver; and

screwing the second locking cap into a head of the second fastener to secure the second end of the elongate member to the second fastener.

The method of claim 18, further comprising:

removing the first tower from the first fastener; and

removing the second lower from the second fastener.

A surgical method for inserting a fusion system, comprising:

exposing a patient's vertebrae:

obtaining the fusion system:

inserting a first fastener into a first vertebra;

inserting a second fastener into a second vertebra adjacent to the first vertebra; and

coupling the first fastener and second fastener.

21. The method of claim 20. wherein the fusion system comprises,

the first fastener;

the second fastener;

an elongate member with a first end and a second end, wherein the first end is secured to the first fastener and the second end is secured to the second fastener;

a first locking cap with a driver opening on a top surface and a recess on a bottom surface, wherein the first locking cap couples to the first fastener, and

a second locking cap with a driver opening on a top surface and a recess on a bottom surface, wherein the second locking cap couples to the second fastener.

22. The method of claim 21. wherein the fusion system further comprises:

at least one insertion tower for coupling to at least one of the first fastener and the second fastener: and

at least one screwdriver for coupling to at least one of the first fastener, the second fastener, the first locking cap, and the second locking cap.

The method of claim 22. wherein the at least one insertion tower comprises: a body with a first end and a second end;

a central opening extending through the body along a longitudinal axis from the first end to die second end;

a channel extending from the second end toward the first end and through the body to the central opening,

at taut one slot extending from the second end toward the first end and positioned spaced apart from and parallel to the channel; and

a groove inset into the body of the insertion tower at the second end and sized to receive a ridge on the exterior surface of at least one of the first fastener and the second fastener: and

wherein the at least one screwdriver comprises:

a handle portion: and

a shaft portion coupled to a central pan of the handle portion, wherein the handle portion is perpendicular to the shaft portion, the shaft portion comprising: a shaft with a first end and a second end;

a screw member positioned at the second end for engaging at least one of the first fastener and the second fastener;

24 The method of claim 23, wherein inserting a first fastener into a first vertebra comprises

coupling the first fastener to the second end of the at least one insertion tube; inserting the screw member and the protrusion of the at least one screwdriver into a head of the first fastener; and

rotating the screwdriver to drive the first fastener into the first vertebra.

25. The method of claim 24. wherein inserting a second fastener into a second vertebra comprises:

coupling the second fastener to the second end of the at least one insertion tube: inserting the screw member and the protrusion of the at least one screwdriver into a head of the first fastener; and

rotating the screwdriver to drive the first fastener into the first vertebra.

26. The method of claim 25. wherein coupling the first fastener to the second fastener comprises:

inserting the first end of the elongate member into the head of the first fastener: coupling the screwdriver to the first locking cap:

screwing the first locking cap into the head of the first fastener ro secure the first end of the elongate member between the head of the first fastener and a bottom surface of the first locking cap:

inserting the second end of the elongate member into the head of the second fastener:

coupling the screwdriver to the second locking cap: and

screwing the second locking cap into the head of the second fastener to secure the second end of the elongate member between the head of the second fastener and a bottom surface of the second locking cap.

27. The method of claim 21 , wherein inserting the elongate member into the first fastener and the second fastener may move the first fastener and the second fastener and wherein the movement of the first and second fasteners may be selected from adding compression forces, maintaining compression forces, adding distraction forces, and maintaining distraction forces.

28. A fusion system, comprising:

a first one piece screw:

a second one piece screw;

a rod inserted into the first one piece screw at a first end and the second one piece screw at a second end, wherein the first one piece screw accommodates multi-axial positioning of the first one piece screw with respect to the rod and wherein the second one piece screw accommodates mulfi -axial positioning of the second one piece screw with respect to the rod;

a first locking cap with a driver opening on a top surface and a recess on a bottom surface, wherein the first locking cap couples to the first one piece screw: and

a second locking cap with a driver opening on a top surface and a recess on a bottom surface, wherein the second locking cap couples to the second one piece screw.