WO2025163480A1 - Devices facilitating spinal rod reduction - Google Patents
Devices facilitating spinal rod reductionInfo
- Publication number
- WO2025163480A1 WO2025163480A1 PCT/IB2025/050913 IB2025050913W WO2025163480A1 WO 2025163480 A1 WO2025163480 A1 WO 2025163480A1 IB 2025050913 W IB2025050913 W IB 2025050913W WO 2025163480 A1 WO2025163480 A1 WO 2025163480A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- rod
- receiver
- guide portion
- set screw
- reduction
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
- A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
- A61B17/7083—Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
- A61B17/7086—Rod reducers, i.e. devices providing a mechanical advantage to allow a user to force a rod into or onto an anchor head other than by means of a rod-to-bone anchor locking element; rod removers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
- A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
- A61B17/7091—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for applying, tightening or removing longitudinal element-to-bone anchor locking elements, e.g. caps, set screws, nuts or wedges
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
Definitions
- the present disclosure relates to spinal surgery and, more particularly, to devices and methods facilitating spinal rod reduction during spinal surgery.
- Surgical treatment of such spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and/or implantable prosthetics.
- surgical treatment may include implantation of a system of rods and screws to provide spinal stabilization and maintain spinal curve correction.
- a rod reduction and receiver device including a guide portion and a receiver portion.
- the guide portion includes an outer wall surrounding a lumen extending longitudinally through the guide portion.
- the guide portion further includes first and second slots defined transversely through the outer wall to communicate with the lumen.
- the guide portion is configured to receive a rod transversely across the lumen and through the first and second slots and to facilitate reduction of the rod relative to the guide portion.
- the receiver portion includes a base and first and second side walls extending from the base to define first and second saddles between the first and second side walls.
- the base is configured to operably receive a head of a screw.
- the first and second saddles are configured to receive the rod upon reduction of the rod from the guide portion into the receiver portion.
- a set screw assembly is movable through the lumen of the guide portion.
- the set screw assembly includes an alignment collar configured to extend at least partially into the first and second slots of the guide portion and to slide through the first and second slots to reduce the rod towards the receiver portion..
- the set screw assembly further includes a body having a proximal portion configured for operable engagement with the guide portion to facilitate reduction of the rod from the guide portion into the receiver portion and a distal portion configured for operable engagement with the receiver portion to retain the rod within the first and second saddles after reduction of the rod into the receiver portion.
- the proximal portion of the body of the set screw assembly is configured for threaded engagement with the guide portion such that rotational driving of the proximal portion of the set screw assembly relative to the guide portion reduces the rod relative to the guide portion.
- the proximal portion of the body of the set screw assembly and the guide portion cooperate to define a one-way rachet mechanism for incremental advancement of the set screw assembly through the lumen of the guide portion to incrementally reduce the rod relative to the guide portion.
- the distal portion of the body of the set screw assembly is configured for threaded engagement within the receiver portion to retain the rod within the first and second saddles after reduction of the rod into the receiver portion.
- the alignment collar of the set screw assembly is rotatably coupled to the body of the set screw assembly.
- the proximal and distal portions of the body of the set screw assembly are removably connected to one another.
- the proximal and distal portions of the body of the set screw assembly may be initially monolithically formed defining a transition therebetween, wherein the transition is configured to break to separate the proximal and distal portions of the body of the set screw assembly from one another.
- the alignment collar of the set screw assembly includes a base slidable within the lumen of the guide portion and first and second arms slidable through the first and second slots of the guide portion.
- the first and second arms define proximal ends attached to the base of the alignment collar and free distal ends configured to contact the rod to reduce the rod towards the receiver portion.
- the free distal ends of the first and second arms of the alignment collar may be configured to partially receive the rod within cut-outs defined therein.
- the guide portion and the receiver portion are removably connected to one another.
- the guide portion and the receiver portion may be initially monolithically formed as the body defining at least one transition therebetween, wherein the at least one transition is configured to break to separate the receiver portion from the guide portion.
- a spinal surgical system provided in accordance with the present disclosure includes a rod, a screw defining a head and a shank extending from the head, and the rod reduction and receiver device according to any of the aspects detailed above or otherwise herein.
- Another spinal surgical system provided in accordance with the present disclosure includes a rod, a plurality of screws each defining a head and a shank extending from the head, and a plurality of the rod reduction and receiver devices according to any of the aspects detailed above or otherwise herein.
- a method of installing a spinal rod and screw system in accordance with the present disclosure includes approximating a device according to any of the aspects detailed above or otherwise herein relative to a screw anchored in spinal bone to receive a head of the screw within a receiver portion of the device, inserting a rod transversely through first and second slots defined within a guide portion of the device, sliding a set screw assembly through the guide portion to reduce the rod from the guide portion to the receiver portion, engaging a set screw of the set screw assembly within the receiver portion to retain the rod within the receiver portion, separating the guide portion from the receiver portion, and removing the guide portion, thereby leaving the receiver portion operably coupling the rod with the screw.
- sliding the set screw assembly includes incrementally advancing the set screw assembly via a one-way ratchet mechanism or rotationally driving a portion of the set screw assembly with the portion of the set screw assembly threadingly engaged with the guide portion.
- the method further includes separating a proximal portion of the set screw assembly from a distal portion of the set screw assembly.
- FIG. 1 illustrates a rod and screw system for treating disorders of the spine in accordance with the present disclosure installed on a patient’s spine;
- FIG. 2 is a perspective view of a rod reduction and receiver device in accordance with the present disclosure including a body and an insert shown cooperating to reduce a rod relative to a screw;
- FIG. 3 is a perspective view of the body of the rod reduction and receiver device of FIG. 2;
- FIG. 4A is an enlarged, longitudinal, cross-sectional view of the area of detail indicated as “4A” in FIG. 3;
- FIG. 4B is an enlarged, perspective view of the area of detail indicated as “4B” in FIG. 3;
- FIG. 5 is a perspective view of the insert of the rod reduction and receiver device of FIG. 2;
- FIGS 9A-9H are perspective views progressively illustrating assembly of the rod reduction and receiver device of FIG. 2 with a screw, reducing a rod relative to the screw utilizing the rod reduction and receiver device of FIG. 2, installing a set screw to retain the rod within the receiver of the rod reduction and receiver device of FIG. 2, and removing the body portion of the rod reduction and receiver device of FIG. 2 in accordance with the present disclosure;
- FIG. 10 is a perspective view of another rod reduction and receiver device in accordance with the present disclosure including a body and an insert shown cooperating to reduce a rod relative to a screw;
- FIG. 11 is a perspective view of still another rod reduction and receiver device in accordance with the present disclosure including a body and a set screw assembly shown cooperating to reduce a rod relative to a screw;
- FIGS. 12 and 13 are perspective and longitudinal, cross-sectional views, respectively, of the set screw assembly of the rod reduction and receiver device of FIG. 11;
- FIG. 14 is an enlarged, perspective view of a distal portion of the rod reduction and receiver device of FIG. 11 shown reducing a rod relative to a screw;
- FIG. 16 is a longitudinal, cross-sectional view of yet another rod reduction and receiver device in accordance with the present disclosure including a body and a set screw assembly; and [0037] FIGS. 17A-17D are perspective views progressively illustrating assembly of a plurality of rod reduction and receiver devices in accordance with the present disclosure with a plurality of screws and a shared rod.
- System 10 includes one or more first screw assemblies 100 (e.g., polyaxial screw assemblies), one or more second screw assemblies 200 (e.g., fixed angle screw assemblies), one or more connector components 300, and one or more rods 400.
- first screw assemblies 100 e.g., polyaxial screw assemblies
- second screw assemblies 200 e.g., fixed angle screw assemblies
- connector components 300 e.g., fixed angle screw assemblies
- rods 400 e.g., fixed angle screw assemblies
- Each of the screw assemblies 100, 200 is anchored in a vertebra “V” of the patient’s spine “S.”
- Each of the one or more connector components 300 connects a screw assembly 100, 200 or a rod 400 with another screw assembly 100, 200 or rod 400.
- Each rod 400 is received within one or more screw assemblies 100, 200 and generally extends along at least a portion of a length of the patient’s spine “S.”
- screw assemblies 100, 200 are shown anchored in pedicle bone, it is also contemplated that screw assemblies 100, 200 can be anchored in cortical bone, or in any other suitable bone, whether vertebral or otherwise.
- system 10 may include any other suitable components (e.g., screw assemblies, plates, connector components, rods, couplers, etc.) in addition to and/or as a substitute for any of the illustrated components of system 10.
- each screw assembly 100 includes a screw 110 (FIG. 2), a receiver 120, and a set screw 130.
- Each screw assembly 200 likewise includes a screw (not shown), a receiver 220, and a set screw 230.
- Screw assemblies 100, 200 may differ from one another, as noted above, in that screw assemblies 100 are polyaxial screw assemblies while screw assemblies 200 are fixed angle screw assemblies. That is, screws 110 (FIG. 2) of screw assemblies 100 are permitted to articulate in multiple directions within and relative to receivers 120 of screw assemblies 100, while the screws of screw assemblies 200 are retained in fixed orientation within and relative to receivers 220 of screw assemblies 200.
- Device 500 may be utilized in minimally invasive surgery (MIS) or may be installed in any other suitable manner.
- Device 500 includes a body 520 and an insert 560.
- Body 520 is configured to operably couple to a screw 110, to receive a rod 400, to operably receive insert 560 to facilitate reduction of rod 400 relative to screw 110, and to operably engage a set screw 130 to operably couple rod 400 with screw 110.
- Body 520 includes a guide portion 522 and a receiver portion 524.
- Guide portion 522 is selectively removable from receiver portion 524, e.g., once rod 400 has been reduced and set screw 130 at least partially engaged with receiver portion 524 to retain rod 400 therein. Once guide portion 522 is removed from receiver portion 524, the remaining receiver portion 524 of body 520 defines the receiver 120 of screw assembly 100, thus forming screw assembly 100 with screw 110 (which is operably coupled to receiver 120) and set screw 130 (which operably retains rod 400 within receiver 120).
- body 520 includes a guide portion 522 and a receiver portion 524.
- Guide portion 522 and receiver portion 524 of body 520 are integrally formed as a component and, in aspects, are monolithically formed from the same material, e.g., a biocompatible metallic material (such as, without limitation, titanium, cobalt chrome, or stainless steel), from the same manufacturing process, e.g., metal injection molding, machining, or other suitable manufacturing process.
- guide portion 522 and receiver portion 524 may be separate components removably connected to one another.
- guide portion 522 may define a housing configured to fit over one or both of first and second opposing side walls 540 of receiver portion 524.
- the removable connection between guide portion 522 and receiver portion 524 may be made via snap-fit engagement (e.g., of engagement finger(s) of the housing of guide portion 522 with corresponding engagement surface(s) of one or both of side walls 540 of receiver portion 524), threaded engagement, press-fit engagement, spring-pin engagement, bayonet coupling, or in any other suitable manner.
- snap-fit engagement e.g., of engagement finger(s) of the housing of guide portion 522 with corresponding engagement surface(s) of one or both of side walls 540 of receiver portion 524
- threaded engagement e.g., of engagement finger(s) of the housing of guide portion 522 with corresponding engagement surface(s) of one or both of side walls 540 of receiver portion 524
- press-fit engagement e.g., press-fit engagement, spring-pin engagement, bayonet coupling, or in any other suitable manner.
- guide portion 522 of body 520 includes an outer wall 526, a lumen 528, a pair of slots 530, and a pair of engagement tabs 532.
- Outer wall 526 has a substantially cylindrical configuration and defines lumen 528 extending longitudinally therethrough.
- Lumen 528 is open at a proximal end of outer wall 526 and communicates with receiver portion 524 of body 520 at a distal end of outer wall 526.
- guide portion 522 defines a proximal portion 529a wherein lumen 528 defines a first diameter and a distal portion 529b wherein lumen 528 defines a second, smaller diameter.
- Proximal portion 529a may extend a greater longitudinal extent of guide portion 522 as compared to distal portion 529b, e.g., wherein proximal portion 529a extends from about 60% to about 90% of a length of guide portion 522 while distal portion 529b extends from about 5% to about 20% of a length of guide portion 522, although other configurations are also contemplated.
- Slots 530 are defined through outer wall 526 at diametrically opposed positions such that slots 530 are aligned with one another. Slots 530 extend longitudinally along outer wall 526. Slots 530 are spaced from the proximal end of outer wall 526 and extend to the distal end of outer wall 526 to communicate with receiver portion 524 of body 520. Slots 530 communicate with lumen 528 and are configured to slidably receive rod 400 therein.
- Engagement tabs 532 define cantilever configurations including fixed ends disposed towards the proximal end of guide portion 522 of body 520 with engagement tabs 532 extending distally and longitudinally therefrom along portions of slots 530 to free ends of engagement tabs 532.
- the free ends of each engagement tab 532 includes an engagement tooth 534 that extends inwardly through a corresponding slot 530 of guide portion 522 of body 520 and into lumen 528.
- Engagement teeth 534 define one-way ratchet configurations such as, for example, having a distal locking surface 535a extending substantially perpendicular relative to a longitudinal extent of body 520 and a proximal camming surface 535b angled relative to the longitudinal extent of body 520.
- Engagement tabs 532 are resiliently flexible from an initial position, wherein engagement teeth 534 extend radially inwardly into lumen 528, to a flexed position, wherein engagement teeth 534 are urged radially outwardly such that engagement teeth 534 are displaced from lumen 528 or extend into lumen 528 a lesser radial distance than in the initial position.
- receiver portion 524 of body 520 forms receiver 120 of screw assembly 100 (FIG. 1) upon detachment of guide portion 522 from receiver portion 524.
- Receiver portion 524 includes a base 538 and first and second opposing side walls 540 extending upwardly from base 538 in spaced relation relative to one another to define first and second opposing saddles 542. Saddles 542 align with and form distal end portions of slots 530 of guide portion 522 of body 520.
- Base 538 defines an internal cavity 543 open at a proximal end thereof (communicating with a volume defined between side walls 540) and at a distal end thereof (through a floor of base 538).
- Internal cavity 543 of base 538 is configured to receive head 112 of screw 110 therein.
- head 112 of screw 110 is operably receivable within internal cavity 543 of base 538 of receiver portion 524 to permit angling of screw 110 relative to receiver portion 524 in at least one direction.
- head 112 of screw 110 and a portion of internal cavity 543 may define substantially spherical configurations to facilitate angling of screw 110 relative to receiver portion 524 in any suitable direction.
- head 112 of screw 110 is fixed relative to receiver portion 524 upon receipt therein such that screw 110 extends from receiver portion 524 at a fixed angle.
- receiver 120 may be configured to rotate relative to screw 110, e.g., to re-orient a rod 400 (FIG. 1) received within receiver portion 524 relative to screw 110.
- receiver portion 524 may be rotationally fixed relative to screw 110.
- Side walls 540 of receiver portion 524 define saddles 542 therebetween.
- Saddles 542 define substantially U-shaped configurations and are configured to receive a rod 400 (FIG. 1) therethrough.
- Side walls 540 further include threading 544 defined on internal surfaces thereof. Threading 544 is configured to permit threaded engagement of set screw 130 within receiver portion 524 and between side walls 540 to thereby close the open proximal end of receiver portion 524 and retain rod 400 within saddles 542 while permitting sliding and/or rotation of rod 400 within saddles 542.
- the proximal ends of side walls 540 of receiver portion 524 of body 520 are initially connected to (e.g., monolithically formed with) the distal end of outer wall 526 of guide portion 522 of body 520 to define transitions 546 therebetween.
- the internal surface of outer wall 526 of distal portion 529b of guide portion 522 may define threading 548 that cooperates with threading 544 of side walls 540 of receiver portion 524 to define a continuous threaded region while guide portion 522 and receiver portion 524 remain connected to one another.
- Transition 546 defines a pre-determined break point wherein transition 546 breaks to thereby separate guide portion 522 from receiver portion 524.
- transition 546 may be configured such that opposing inward forces applied from opposite sides of guide portion 522 break transition 546, thereby separating guide portion 522 from receiver portion 524. Instead of inward force, outward for may be applied to break transition. As another alternative, instead of linear forces, torque may be applied to guide portion 522 to break transition 546 and separate guide portion 522 from receiver portion 524. With guide portion 522 separated from receiver portion 524 (regardless of the manner of breaking transition 546), side walls 540 of receiver portion 524 define free proximal ends.
- receiver portion 524 defines receiver 120 of screw assembly 100 (see FIG. 1 and 9H).
- insert 560 is substantially cylindrical and configured for slidable receipt within lumen 528 of guide portion 522. Further, insert 560 defines an internal lumen 562 extending longitudinally therethrough and a plurality of annular grooves 564 defined within an exterior surface of insert 560 and longitudinally spaced-apart along a portion of a length of insert 560.
- Internal lumen 562 of insert 560 may be configured to receive set screw 130 therethrough to enable set screw 130 to be inserted through insert 560 when insert 560 is disposed within lumen 528 of guide portion 522 to position set screw 130 adjacent threading 548 of outer wall 526 of guide portion 522 to facilitate advancement of set screw 130 from guide portion 522 into threaded wengagement with threading 544 of side walls 540 of receiver portion 524 to retain rod 400 within saddles 542 of receiver portion 524 (see FIG. 4B).
- Annular grooves 564 of insert 560 are configured to incrementally engage engagement teeth 534 of engagement tabs 532 as insert 560 is advanced through lumen 528 of guide portion 522 towards receiver portion 524, thereby defining a one-way way ratchet configuration wherein insert 560 is retained in position via engagement of engagement teeth 534 within an annular groove 564, wherein insert 560 is permitted to be advanced through lumen 528 of guide portion 522 towards receiver portion 524 with engagement teeth 534 incrementally moving from an annular groove 564 to a next annular groove 564, and wherein insert 560 is inhibited from being withdrawn from lumen 528 of guide portion 522 due to the engagement of engagement teeth 534 within an annular groove 564.
- insert 560 may be incrementally advanced (and retained in position) through guide portion 522 to thereby reduce rod 400 from guide portion 522 towards receiver portion 524.
- screw 110 includes a head 112 configured for receipt within receiver 120 and a shank 114 including threading 118 to facilitate driving of shank 114 into and retention of shank 114 within tissue, e.g., vertebral bone, although other configurations are also contemplated.
- Screw 110 may be formed from a metallic material such as, for example, titanium or cobalt chrome.
- suitable metallic materials forming screw 110 such as, for example, stainless steel, are also contemplated, as are configurations wherein screw 110 is formed from multiple materials, e.g., wherein head 112 is formed from a first material and wherein shank 114 is formed from a second, different material.
- Rod 400 is shown in FIG. 7.
- Rod 400 may define a substantially cylindrical configuration of any suitable diameter and may be formed from a metallic material such as, for example, titanium or cobalt chrome, although other suitable metallic materials such as, for example, stainless steel, are also contemplated.
- rod 400 is configured to be inserted transversely through slots 530 of guide portion 522 of body 520 and longitudinally reduced (e.g., under urging from insert 560) through guide portion 522 of body 520 into receiver portion 524 of body 520.
- FIG. 8 illustrates set screw 130.
- Set screw 130 defines a generally cylindrical configuration and includes a body 132 and a cap 134.
- Body 132 includes threading 136 defined about an exterior annular surface of body 132.
- threading 136 is configured to enable threaded engagement of set screw 130 with threading 548 of guide portion 522 (in aspects where provided) and threading 544 of side walls 540 of receiver portion 524.
- Cap 134 of set screw 130 may be coupled to body 132 via a transition 138.
- transition 138 defines a pre-determined break point wherein transition 138 breaks to thereby separate cap 134 from body 132.
- cap 134 defines a cavity (not explicitly shown) having a suitable geometric, e.g., hexagonal, star-shaped, etc., cross-section configured to facilitate engagement with an assembly tool (not shown), e.g., a rotational driver, to provide the torque input to cap 134 threadingly engage set screw 130 with threading 548 and/or threading 544 and to provide the input torque to reach the pre-determined break point for separating cap 134 from body 132.
- an assembly tool e.g., a rotational driver
- transition 138 is omitted such that cap 134 is not removable, or cap 134 may be omitted entirely.
- set screw 130 is insertable and advanceable through internal lumen 562 of insert 560.
- cap 134 is at least partially receivable within lumen 562 of insert 560 at a distal end of insert 560 and/or set screw 130 is configured to abut a distal end of insert 560. In these configurations, insert 560 advances set screw 130 through guide portion 522 to urge set screw 130 into rod 400 to reduce rod 400.
- set screw 130 is advanced by insert 560 until set screw 130 is positioned adjacent threading 548 or threading 544, at which point set screw 130 may be rotationally driven (e.g., via rotational driving of insert 560 or a driver tool inserted through insert 560) to thereby engage set screw 130 with threading 548 and/or threading 544.
- FIGS. 9A-9H installation of rod reduction and receiver device 500 to operably couple a rod 400 to a screw 110 in accordance with the present disclosure is detailed.
- body 520 of device 500 led by receiver portion 524 thereof, is approximated relative to a head 112 of a screw 110 that has been anchored in a vertebra “V” of the patient’s spine “S” (see FIG. 1).
- body 520 of device 500 is approximated relative to head 112 of screw 110 such that head 112 of screw 110 is inserted through distal end of base 538 of receiver portion 524 and is captured within internal cavity 543 of receiver portion 524.
- a bushing, pins, a collar, and/or any other suitable structure(s) may be utilized to retain head 112 of screw 110 within internal cavity 543 of base 538 of receiver portion 524.
- head 112 of screw 110 may be retained in fixed orientation or may be configured for angulation in at least one degree of freedom.
- rod 400 is inserted transversely through slots 530 of guide portion 522 of body 520 such that rod 400 extends through body 520, e.g., across lumen 528 thereof.
- insert 560 may be inserted into lumen 528 of guide portion 522.
- insert 560 is incrementally advanced through guide portion 522 of body 520 via the one-way ratcheting engagement of engagement teeth 534 within annular grooves 564 (see also FIGS. 4A and 5) to thereby reduce rod 400 towards receiver portion 524 of body 520.
- set screw 130 is inserted through insert 560 and threadingly advanced into and/or along side walls 540 of receiver portion 524 of body 520 to thereby further urge rod 400 to the final position (if necessary) and retain rod 400 within saddles 542 of receiver portion 524 of body 520, as shown in FIG. 9G (wherein insert 560 has been removed for illustration purposes).
- transition 138 may break to thereby separate cap 134 of set screw 130 from body 132 of set screw 130 such that cap 134 may be removed.
- guide portion 522 (including insert 560 therein) may be separated from receiver portion 524 and removed, thus leaving the fully assembled screw assembly 100 including screw 110 (anchored in a vertebra “V” of the patient’s spine “S” (FIG. 1)), receiver 120 (defined by the separated receiver portion 524 of body 520, operably coupled to screw 110, and receiving rod 400 therethrough), and set screw 130 (retaining rod 400 within receiver 120).
- FIG. 10 another rod reduction and receiver device provided in accordance with the present disclosure is shown generally identified by reference numeral 1000.
- Device 1000 includes a body 1020 and an insert 1060.
- Body 1020 is configured to operably couple to a screw 110, to receive a rod 400, to operably receive insert 1060 to facilitate reduction of rod 400 relative to screw 110, and to facilitate operable engagement of a set screw (not shown) with a portion of body 1020 to operably couple rod 400 with screw 110.
- Body 1020 includes a guide portion 1022 and a receiver portion 1024 and is configured similar to body 520 of device 500 (FIG. 2) except as explicitly contradicted below. Accordingly, differences between device 1000 and device 500 (FIG. 2) are described in detail below while similarities are summarily described or omitted entirely for purposes of brevity.
- Guide portion 1022 rather than including engagement tabs having engagement teeth as detailed above with respect to 500 (FIG. 2), includes internal threading 1032 defined on the interior annular surface portions of outer wall 1026 of proximal portion 1029a of guide portion 1022. Further, rather than insert 1060 including annular grooves as detailed above with respect to 500 (FIG. 2), insert 1060 includes threading 1064 defined on the annular exterior surface thereof that is configured to engage threading 1032 of proximal portion 1029a of guide portion 1022 of body 1020 upon insertion of insert 1060 into guide portion 1022 of body 1020.
- device 1000 enables a threaded engagement between insert 1060 and guide portion 1022 of body 1020 to reduce rod 400 to a desired position, e.g., within receiver portion 1024 of body 1020.
- threading 1032 of proximal portion 1029a of guide portion 1022 of body 1020 defines a different pitch compared to the threading (if provided) of distal portion 1029b of guide portion 1022 and/or the threading of receiver portion 1024.
- the pitch of threading 1032 may be steeper than the threadings of distal portion 1029b of guide portion 1022 and/or receiver portion 1024 such that insert 1060 is capable of being advanced more rapidly through guide portion 1022 of body 1020 to reduce rod 400 more quickly while threaded engagement of the set screw 130 with receiver portion 1024 of body 1020 can be more finely controlled via the relatively shallower threadings of distal portion 1029b of guide portion 1022 and/or receiver portion 1024.
- the relatively larger diameter proximal portion 1029a of guide portion 1022 of body 1020 enables slidable passage of the set screw therethrough without engagement of threads, while, due to the relatively smaller diameter of distal portion 1029b of guide portion 1022, set screw is threadingly engaged therein and is required to be rotated to advance the set screw through the distal portion 1029b of guide portion 1022 and into receiver portion 1024.
- the set screw may be inserted through insert 1060 of device 1000 to threadingly engage receiver portion 1024 of body 1020 to operably retain rod 400 therein.
- the set screw may be at least partially receivable within an internal lumen of insert 1060 or disposed at a distal end of insert 1060 such that insert 1060 advances the set screw through guide portion 1022 to urge the set screw into rod 400 to reduce rod 400.
- the set screw is part of a set screw assembly, similarly as detailed below.
- insert 1060 may define a cavity 1068 having a suitable geometric, e.g., hexagonal, star-shaped, etc., cross-section configured to facilitate engagement with an assembly tool (not shown), e.g., a rotational driver, to provide torque input to insert 1060 to threadingly advance insert 1060 through guide portion 1022 of body 1020 and to threadingly engage the set screw with the threading of receiver portion 1024 of body 1020.
- an assembly tool e.g., a rotational driver
- Device 1100 includes a body 1120 and a set screw assembly 1180.
- Body 1120 is configured to operably couple to a screw 110, to receive a rod 400, to operably receive set screw assembly 1180 to facilitate reduction of rod 400 relative to screw 110, and to facilitate operable engagement of a distal screw portion 1190 of set screw assembly 1180 with a receiver portion 1124 of body 1120 to operably couple rod 400 with screw 110.
- Body 1120 includes a guide portion 1122 and a receiver portion 1124.
- Guide portion 1122 is similar to and includes the features of guide portion 1022 of device 1000 (FIG. 10). That is, guide portion 1122 includes an outer wall 1126, a lumen 1128, and a pair of opposed slots 1130.
- Guide portion 1122 defines a proximal portion 1129a, wherein lumen 1128 defines a first diameter and wherein outer wall 1126 includes internal threading 1132 defined on the interior annular surface portions thereof, and a distal portion 1129b, wherein lumen 1128 has a second diameter and outer wall 1126 includes internal threading 1148 of a second pitch.
- the first diameter is larger than the second diameter and the first pitch is steeper than the second pitch.
- Guide portion 1122 of body 1120 may otherwise be similar to and include any of the features of guide portion 522 of body 520 of device 500 (FIG. 2).
- Receiver portion 1124 of body 1120 forms receiver 120 of screw assembly 100 (FIG. 1) upon detachment of guide portion 1122 from receiver portion 1124.
- Receiver portion 1124 is similar to and may include any of the features of receiver portion 524 of body 520 of device 500 (FIG. 2).
- set screw assembly 1180 includes a body 1182, an alignment collar 1184, and a retention ring 1186.
- Body 1182 includes a proximal screw portion 1188, a distal screw portion 1190, and a central portion 1192 connecting proximal and distal screw portions 1188, 1190 with one another.
- Alignment collar 1184 includes a base 1194 rotatably disposed about central portion 1192 of body 1182 and first and second arms 1196 extending from base 1194 distally on either side of distal screw portion 1190.
- Retention ring 1186 is engaged, e.g., welded or otherwise fixed, to central portion 1192 of body 1182 to rotatably retain alignment collar 1184 about central portion 1192 of body 1182 between retention ring 1186 and a proximal annular protrusion 1198 of central portion 1192.
- Proximal screw portion 1188 of set screw assembly 1180 defines a first diameter and includes first threading 1189 while distal screw portion 1190 defines a second diameter and includes second threading 1191.
- First diameter and first threading 1189 are configured to enable threaded engagement of proximal screw portion 1188 with threading 1132 of proximal portion 1129a of guide portion 1122 of body 1120.
- Second diameter and second threading 1191 are configured such that distal screw portion 1190 slides through proximal portion 1129a of guide portion 1122 of body 1120 (without threaded engagement therewith) and is configured to enable threaded engagement of distal screw portion 1190 with threading 1148 of distal portion 1129b of guide portion 1122 of body 1120 and threading 1144 of receiver portion 1124.
- threadings 1132, 1189 define steeper pitches compared to threadings 1148, 1191 (and threading 1144), thus enabling faster advancement of set screw assembly 1180 through proximal portion 1129a of guide portion 1122 of body 1120 and more controlled or fine-tuned advancement of set screw assembly 1180 through distal portion 1129b of guide portion 1122 of body 1120 and receiver portion 1124 of body 1120.
- a first transition 1193a is defined between central portion 1192 and distal screw portion 1190 and a second transition 1193b is defined between a cap 1200 of distal screw portion 1190 and a threaded portion 1202 (which includes threading 1191) of distal screw portion 1190.
- the breaking threshold of first transition 1193a is less than that of second transition 1193b such that first transition 1193a breaks first to separate distal screw portion 1190 from the remainder of body 1182 of set screw assembly 1180.
- second transition 1193b breaks to separate cap 1200 of distal screw portion 1190 from threaded portion 1202 (which includes threading 1191) of distal screw portion 1190.
- Set screw assembly 1180 is operably positioned within lumen 1128 of body 1120 of device 1100 and, initially, is disposed towards the proximal end of body 1120. With set screw assembly 1180 positioned within lumen 1128 of body 1120, first and second arms 1196 of alignment collar 1184 extend at least partially into slots 1130 of guide portion 1122 of body 1120 to rotationally fix alignment collar 1184 relative to guide portion 1122 while permitting sliding of alignment collar 1184 (and, thus, set screw assembly 1180) through guide portion 1122.
- the free ends of first and second arms 1196 of alignment collar 1184 may define semi-circular cut outs 1199 configured to receive and at least partially conform about rod 400 when rod 400 extends through guide portion 1122 of body 1120.
- set screw assembly 1180 is operably positioned within lumen 1128 of body 1120 of device 1100 towards the proximal end of body 1120.
- set screw assembly 1180 is operably positioned within the proximal end of lumen 1128 during manufacturing. In this position, body 1120 of device 1100, led by receiver portion 1124 thereof, is approximated relative to a head 112 of a screw 110 that has been anchored in a vertebra “V” of the patient’s spine “S” (see FIG.
- rod 400 is inserted transversely through slots 1130 of guide portion 1122 of body 1120 such that rod 400 extends through body 1120, e.g., across lumen 1128 thereof, at a position distal of set screw assembly 1180.
- set screw assembly 1180 may be advanced distally through proximal portion 1129a of guide portion 1122 to thereby reduce rod 400.
- an assembly tool (not shown), e.g., a rotational driver, may be engaged within a cavity of body 1182 of set screw assembly 1180 and rotationally driven to rotate body 1182 of set screw assembly 1180 relative to guide portion 1122 of body 1120 such that set screw assembly 1180 is advanced distally via the threaded engagement of first threading 1189 of proximal screw portion 1188 with threading 1132 of proximal portion 1129a of guide portion 1122 of body 1120.
- a rotational driver may be engaged within a cavity of body 1182 of set screw assembly 1180 and rotationally driven to rotate body 1182 of set screw assembly 1180 relative to guide portion 1122 of body 1120 such that set screw assembly 1180 is advanced distally via the threaded engagement of first threading 1189 of proximal screw portion 1188 with threading 1132 of proximal portion 1129a of guide portion 1122 of body 1120.
- first and second arms 1196 of alignment collar 1184 slide through slots 1130 and contact rod 400 (e.g., partially receiving rod 400 within semi-circular cut outs 1199) to thereby urge rod 400 distally, reducing rod 400 towards receiver portion 1124 of body 1120.
- distal screw portion 1190 is translated through lumen 1128 without contacting guide portion 1122.
- distal screw portion 1190 is eventually moved from proximal portion 1129a of guide portion 1122 to distal portion 1129b of guide portion 1122, wherein threading 1191 of distal screw portion 1190 threadingly engages threading 1148 of distal portion 1129b of guide portion 1122. Further rotational driving of set screw assembly 1180 continues to reduce rod 400 via distal advancement of set screw assembly 1180.
- Proximal screw portion 1188 may bottom out within proximal portion 1129a of guide portion 1122 and/or may otherwise be configured to encounter greater resistance once or shortly after threading 1191 of distal screw portion 1190 threadingly engages threading 1148 of distal portion 1129b of guide portion 1122 such that further torquing set screw assembly 1180 breaks first transition 1193 a to thereby separate distal screw portion 1190 from the remainder of body 1182 of set screw assembly 1180.
- distal screw portion 1190 With distal screw portion 1190 separated from the remainder of set screw assembly 1180, distal screw portion 1190 may be further rotationally driven (while the remainder of set screw assembly 1180 remains in position) to advance distal screw portion 1190 from distal portion 1129b of guide portion 1122 into receiver portion 1124 of body 1120 to threadingly engage threading 1144 of receiver portion 1124 sufficiently so as to urge rod 400 into position within receiver portion 1124 and retain rod 400 within receiver portion 1124 via the engagement of distal screw portion 1190 therein.
- second transition 1193b may break to separate cap 1200 of distal screw portion 1190 from threaded portion 1202 of distal screw portion 1190 such that cap 1200 may be removed. Further, with additional momentary reference to FIG.
- guide portion 1122 including the separated portion of set screw assembly 1180 retained therein may be separated from receiver portion 1124 and removed, thus leaving the fully assembled screw assembly 100 including screw 110 (anchored in a vertebra “V” of the patient’s spine “S”), receiver 120 (formed by the separated receiver portion 1124, operably coupled to screw 110, receiving rod 400 therethrough), and distal screw portion 1190 (functioning as the set screw) retaining rod 400 within receiver 120.
- FIG. 16 still yet another rod reduction and receiver device provided in accordance with the present disclosure is shown generally identified by reference numeral 1600.
- Device 1600 is similar to device 1100 (FIGS. 11-15B) and, thus, only differences therebetween are described in detail below while similarities are summarily described or omitted entirely for purposes of brevity.
- Device 1600 includes a body 1620 and a set screw assembly 1680.
- Body 1620 includes a guide portion 1622 and a receiver portion 1624.
- Guide portion 1622 defines a proximal portion 1629a, wherein lumen 1628 defines a first diameter and wherein outer wall 1626 includes annular ratchet teeth 1632 defined on the interior annular surface portions thereof and extending longitudinally therealong, and a distal portion 1629b, wherein lumen 1628 has a second, smaller diameter and threading 1648.
- Set screw assembly 1680 includes a body 1682 having a proximal ratchet portion 1688, a distal screw portion 1690, and a central portion 1692 connecting proximal ratchet portion 1688 and distal screw portion 1190 with one another.
- First and second transitions 1693a, 1693b are defined between central portion 1692 and distal screw portion 1690 and portions of distal screw portion 1690, similarly as detailed above with respect to set screw assembly 1180 (FIGS. 12 and 13).
- Proximal ratchet portion 1688 of set screw assembly 1680 defines a first diameter and includes an annular pawl 1689 while distal screw portion 1690 defines a second diameter and includes threading 1691.
- First diameter and annular pawl 1689 are configured to enable incremental one-way ratcheting engagement of proximal ratchet portion 1688 with annular ratchet teeth 1632 of proximal portion 1629a of guide portion 1622 of body 1620 to thereby enable incremental advancement of set screw assembly 1680 through proximal portion 1629a of guide portion 1622 of body 1620.
- Second diameter and second threading 1691 are configured such that distal screw portion 1690 slides through proximal portion 1629a of guide portion 1622 of body 1620 (without engagement therewith) and is configured to enable threaded engagement of distal screw portion 1690 with threading 1648 of distal portion 1629b of guide portion 1622 of body 1120 and into threaded engagement within receiver portion 1624 of body 1620.
- device 1600 operates similar to device 1100 (FIGS. 11-15B) except that, rather than threaded engagement and advancement of the set screw assembly through the proximal portion of the guide portion of the body as with device 1100 (FIGS. 11-15B), proximal ratchet portion 1688 of set screw assembly 1680 of device 1600 is configured for one-way ratcheting engagement and incremental advancement through proximal portion 1629a of guide portion 1622 of body 1620.
- rod 400 need not be actively reduced within each device 1700, thereby saving installation time.
- rod 400 may first be fed through each of the plurality of devices 1700. Thereafter, some (but not all) of the devices 1700 may be utilized to reduce rod 400 into position or adjacent to a final position thereof.
- active reduction according to any of the aspects detailed hereinabove may be performed on alternating devices 1700 along rod 400, every third device 1700 along rod 400, or in any other suitable manner.
- a rod reduction and receiver device comprising: a guide portion including an outer wall surrounding a lumen extending longitudinally through the guide portion and first and second slots defined transversely through the outer wall to communicate with the lumen, the guide portion configured to receive a rod transversely across the lumen and through the first and second slots and to facilitate reduction of the rod relative to the guide portion; a receiver portion including a base and first and second side walls extending from the base to define first and second saddles between the first and second side walls, the base configured to operably receive a head of a screw, the first and second saddles configured to receive the rod upon reduction of the rod from the guide portion into the receiver portion; and a set screw assembly movable through the lumen of the guide portion, the set screw assembly including an alignment collar configured to extend at least partially into the first and second slots of the guide portion and to slide through the first and second slots to reduce the rod towards the receiver portion.
- Example 4 The rod reduction and receiver device according to example 2, wherein the proximal portion of the body of the set screw assembly and the guide portion cooperate to define a one-way rachet mechanism for incremental advancement of the set screw assembly through the lumen of the guide portion to incrementally reduce the rod relative to the guide portion.
- Example 11 The rod reduction and receiver device according to example 10, wherein the free distal ends of the first and second arms of the alignment collar are configured to partially receive the rod within cut-outs defined therein.
- Example 14 A spinal surgical system, comprising: a rod; a screw defining a head and a shank extending from the head; and the rod reduction and receiver device according to any preceding claim.
- Example 15 A spinal surgical system, comprising: a rod; a plurality of screws, each screw defining a head and a shank extending from the head; and a plurality of the rod reduction and receiver devices according to any preceding example.
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Abstract
A rod reduction and receiver device includes guide and receiver portions. The guide portion defines a lumen and includes a pair of slots in communication with the lumen. The guide portion is configured to receive a rod transversely across the lumen and through the slots and to facilitate reduction of the rod. The receiver portion includes a base and first and second side walls extending from the base to define first and second saddles. The base is configured to operably receive a head of a screw and the saddles are configured to receive the rod upon reduction of the rod into the receiver portion. A set screw assembly is movable through the lumen of the guide portion and includes an alignment collar configured to extend at least partially into the first and second slots and to slide through the slots to reduce the rod.
Description
DEVICES FACILITATING SPINAL ROD REDUCTION
FIELD
[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/626,097, filed 29 January 2024, the entire content of which is incorporated herein by reference.
[0002] The present disclosure relates to spinal surgery and, more particularly, to devices and methods facilitating spinal rod reduction during spinal surgery.
BACKGROUND
[0003] Spinal disorders such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumors, and fracture may result from trauma, disease, and/or degenerative conditions and may cause patient pain, deformity, nerve damage, and/or loss of mobility.
[0004] Surgical treatment of such spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and/or implantable prosthetics. With respect to correction, for example, surgical treatment may include implantation of a system of rods and screws to provide spinal stabilization and maintain spinal curve correction.
[0005] While surgical treatments for spinal correction are generally effective, the implantation of a system of rods and screws can present challenges, especially where the implantation is attempted in minimally invasive surgery (MIS), as MIS requires all components to be introduced and all steps to be performed through small incisions. Regardless of the surgical approach, spinal rod reduction is an important step in the implantation of a system of rods and screws.
SUMMARY
[0006] Terms including “generally,” “about,” “substantially,” and the like, as utilized herein, are meant to encompass variations, e.g., manufacturing tolerances, material tolerances, use and environmental tolerances, measurement variations, design variations, and/or other variations and tolerances, up to and including plus or minus 10 percent. Further, any or all of the aspects described herein, to the extent consistent, may be used in conjunction with any or all of the other aspects described herein.
[0007] Provided in accordance with aspects of the present disclosure is a rod reduction and receiver device including a guide portion and a receiver portion. The guide portion includes an outer wall surrounding a lumen extending longitudinally through the guide portion. The guide portion further includes first and second slots defined transversely through the outer wall to communicate with the lumen. The guide portion is configured to receive a rod transversely across the lumen and through the first and second slots and to facilitate reduction of the rod relative to the guide portion. The receiver portion includes a base and first and second side walls extending from the base to define first and second saddles between the first and second side walls. The base is configured to operably receive a head of a screw. The first and second saddles are configured to receive the rod upon reduction of the rod from the guide portion into the receiver portion. A set screw assembly is movable through the lumen of the guide portion. The set screw assembly includes an alignment collar configured to extend at least partially into the first and second slots of the guide portion and to slide through the first and second slots to reduce the rod towards the receiver portion..
[0008] In an aspect of the present disclosure, the set screw assembly further includes a body having a proximal portion configured for operable engagement with the guide portion to facilitate reduction of the rod from the guide portion into the receiver portion and a distal portion configured for operable engagement with the receiver portion to retain the rod within the first and second saddles after reduction of the rod into the receiver portion.
[0009] In another aspect of the present disclosure, the proximal portion of the body of the set screw assembly is configured for threaded engagement with the guide portion such that rotational driving of the proximal portion of the set screw assembly relative to the guide portion reduces the rod relative to the guide portion.
[0010] In still another aspect of the present disclosure, the proximal portion of the body of the set screw assembly and the guide portion cooperate to define a one-way rachet mechanism for incremental advancement of the set screw assembly through the lumen of the guide portion to incrementally reduce the rod relative to the guide portion.
[0011] In yet another aspect of the present disclosure, the distal portion of the body of the set screw assembly is configured for threaded engagement within the receiver portion to retain the rod within the first and second saddles after reduction of the rod into the receiver portion.
[0012] In still yet another aspect of the present disclosure, the alignment collar of the set screw assembly is rotatably coupled to the body of the set screw assembly.
[0013] In another aspect of the present disclosure, the proximal and distal portions of the body of the set screw assembly are removably connected to one another. In such aspects, the proximal and distal portions of the body of the set screw assembly may be initially monolithically formed defining a transition therebetween, wherein the transition is configured to break to separate the proximal and distal portions of the body of the set screw assembly from one another.
[0014] In yet another aspect of the present disclosure, the alignment collar of the set screw assembly includes a base slidable within the lumen of the guide portion and first and second arms slidable through the first and second slots of the guide portion.
[0015] In still another aspect of the present disclosure, the first and second arms define proximal ends attached to the base of the alignment collar and free distal ends configured to contact the rod to reduce the rod towards the receiver portion. In such aspects, the free distal ends of the first and second arms of the alignment collar may be configured to partially receive the rod within cut-outs defined therein.
[0016] In another aspect of the present disclosure, the guide portion and the receiver portion are removably connected to one another. In such aspects, the guide portion and the receiver portion may be initially monolithically formed as the body defining at least one transition therebetween, wherein the at least one transition is configured to break to separate the receiver portion from the guide portion.
[0017] A spinal surgical system provided in accordance with the present disclosure includes a rod, a screw defining a head and a shank extending from the head, and the rod reduction and receiver device according to any of the aspects detailed above or otherwise herein.
[0018] Another spinal surgical system provided in accordance with the present disclosure includes a rod, a plurality of screws each defining a head and a shank extending from the head, and a plurality of the rod reduction and receiver devices according to any of the aspects detailed above or otherwise herein.
[0019] A method of installing a spinal rod and screw system in accordance with the present disclosure includes approximating a device according to any of the aspects detailed above or otherwise herein relative to a screw anchored in spinal bone to receive a head of the screw within a receiver portion of the device, inserting a rod transversely through first and second slots defined
within a guide portion of the device, sliding a set screw assembly through the guide portion to reduce the rod from the guide portion to the receiver portion, engaging a set screw of the set screw assembly within the receiver portion to retain the rod within the receiver portion, separating the guide portion from the receiver portion, and removing the guide portion, thereby leaving the receiver portion operably coupling the rod with the screw.
[0020] In an aspect of the present disclosure, sliding the set screw assembly includes incrementally advancing the set screw assembly via a one-way ratchet mechanism or rotationally driving a portion of the set screw assembly with the portion of the set screw assembly threadingly engaged with the guide portion. In still yet another aspect of the present disclosure, the method further includes separating a proximal portion of the set screw assembly from a distal portion of the set screw assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The above and other aspects and features of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings wherein like reference numerals identify similar or identical elements.
[0022] FIG. 1 illustrates a rod and screw system for treating disorders of the spine in accordance with the present disclosure installed on a patient’s spine;
[0023] FIG. 2 is a perspective view of a rod reduction and receiver device in accordance with the present disclosure including a body and an insert shown cooperating to reduce a rod relative to a screw;
[0024] FIG. 3 is a perspective view of the body of the rod reduction and receiver device of FIG. 2;
[0025] FIG. 4A is an enlarged, longitudinal, cross-sectional view of the area of detail indicated as “4A” in FIG. 3;
[0026] FIG. 4B is an enlarged, perspective view of the area of detail indicated as “4B” in FIG. 3;
[0027] FIG. 5 is a perspective view of the insert of the rod reduction and receiver device of FIG. 2;
[0028] FIGS. 6 and 7 are perspective views of a screw and rod, respectively, configured for use with the rod reduction and receiver device of FIG. 2;
[0029] FIG. 8 is a perspective view of a set screw configured for use with the rod reduction and receiver device of FIG. 2;
[0030] FIGS 9A-9H are perspective views progressively illustrating assembly of the rod reduction and receiver device of FIG. 2 with a screw, reducing a rod relative to the screw utilizing the rod reduction and receiver device of FIG. 2, installing a set screw to retain the rod within the receiver of the rod reduction and receiver device of FIG. 2, and removing the body portion of the rod reduction and receiver device of FIG. 2 in accordance with the present disclosure;
[0031] FIG. 10 is a perspective view of another rod reduction and receiver device in accordance with the present disclosure including a body and an insert shown cooperating to reduce a rod relative to a screw;
[0032] FIG. 11 is a perspective view of still another rod reduction and receiver device in accordance with the present disclosure including a body and a set screw assembly shown cooperating to reduce a rod relative to a screw;
[0033] FIGS. 12 and 13 are perspective and longitudinal, cross-sectional views, respectively, of the set screw assembly of the rod reduction and receiver device of FIG. 11;
[0034] FIG. 14 is an enlarged, perspective view of a distal portion of the rod reduction and receiver device of FIG. 11 shown reducing a rod relative to a screw;
[0035] FIGS. 15A and 15B are longitudinal, cross-sectional views progressively illustrating reduction of a rod relative to a screw using the rod reduction and receiver device of FIG. 11 ;
[0036] FIG. 16 is a longitudinal, cross-sectional view of yet another rod reduction and receiver device in accordance with the present disclosure including a body and a set screw assembly; and [0037] FIGS. 17A-17D are perspective views progressively illustrating assembly of a plurality of rod reduction and receiver devices in accordance with the present disclosure with a plurality of screws and a shared rod.
DETAILED DESCRIPTION
[0038] Referring to FIG. 1, a system for treating disorders of the spine is generally identified by reference numeral 10 and shown installed on a patient’s spine “S.” System 10 includes one or more first screw assemblies 100 (e.g., polyaxial screw assemblies), one or more second screw assemblies 200 (e.g., fixed angle screw assemblies), one or more connector components 300, and one or more rods 400. Each of the screw assemblies 100, 200 is anchored in a vertebra “V” of the patient’s spine “S.” Each of the one or more connector components 300 connects a screw assembly
100, 200 or a rod 400 with another screw assembly 100, 200 or rod 400. Each rod 400 is received within one or more screw assemblies 100, 200 and generally extends along at least a portion of a length of the patient’s spine “S.” Although screw assemblies 100, 200 are shown anchored in pedicle bone, it is also contemplated that screw assemblies 100, 200 can be anchored in cortical bone, or in any other suitable bone, whether vertebral or otherwise. Further, although one exemplary configuration of system 10 is shown in FIG. 1, it is understood that, depending upon a particular purpose, system 10 may include any other suitable components (e.g., screw assemblies, plates, connector components, rods, couplers, etc.) in addition to and/or as a substitute for any of the illustrated components of system 10.
[0039] Continuing with reference to FIG. 1, each screw assembly 100 includes a screw 110 (FIG. 2), a receiver 120, and a set screw 130. Each screw assembly 200 likewise includes a screw (not shown), a receiver 220, and a set screw 230. Screw assemblies 100, 200 may differ from one another, as noted above, in that screw assemblies 100 are polyaxial screw assemblies while screw assemblies 200 are fixed angle screw assemblies. That is, screws 110 (FIG. 2) of screw assemblies 100 are permitted to articulate in multiple directions within and relative to receivers 120 of screw assemblies 100, while the screws of screw assemblies 200 are retained in fixed orientation within and relative to receivers 220 of screw assemblies 200. Although the aspects and features of the present disclosure are detailed below with respect to screw assemblies 100, it is understood that the aspects and features of the present disclosure likewise apply to screw assemblies 200 and/or any other suitable screw assemblies. For example, in aspects, one or more of screw assemblies 100 may be configured as uniaxial screw assemblies, e.g., wherein the screw 110 (FIG. 2) is permitted to articulate in one direction within and relative to the receiver 120 and is substantially inhibited from articulation relative to the receiver 120 in other directions.
[0040] Turning to FIG. 2, a rod reduction and receiver device provided in accordance with the present disclosure is shown generally identified by reference numeral 500. Device 500 may be utilized in minimally invasive surgery (MIS) or may be installed in any other suitable manner. Device 500 includes a body 520 and an insert 560. Body 520 is configured to operably couple to a screw 110, to receive a rod 400, to operably receive insert 560 to facilitate reduction of rod 400 relative to screw 110, and to operably engage a set screw 130 to operably couple rod 400 with screw 110. Body 520 includes a guide portion 522 and a receiver portion 524. Guide portion 522 is selectively removable from receiver portion 524, e.g., once rod 400 has been reduced and set
screw 130 at least partially engaged with receiver portion 524 to retain rod 400 therein. Once guide portion 522 is removed from receiver portion 524, the remaining receiver portion 524 of body 520 defines the receiver 120 of screw assembly 100, thus forming screw assembly 100 with screw 110 (which is operably coupled to receiver 120) and set screw 130 (which operably retains rod 400 within receiver 120).
[0041] With reference to FIGS. 3, 4A, and 4B, body 520, as noted above, includes a guide portion 522 and a receiver portion 524. Guide portion 522 and receiver portion 524 of body 520 are integrally formed as a component and, in aspects, are monolithically formed from the same material, e.g., a biocompatible metallic material (such as, without limitation, titanium, cobalt chrome, or stainless steel), from the same manufacturing process, e.g., metal injection molding, machining, or other suitable manufacturing process. Alternatively, guide portion 522 and receiver portion 524 may be separate components removably connected to one another. For example, guide portion 522 may define a housing configured to fit over one or both of first and second opposing side walls 540 of receiver portion 524. In this configuration and/or other configurations wherein guide portion 522 and receiver portion 524 are separate components removably connected to one another, the removable connection between guide portion 522 and receiver portion 524 may be made via snap-fit engagement (e.g., of engagement finger(s) of the housing of guide portion 522 with corresponding engagement surface(s) of one or both of side walls 540 of receiver portion 524), threaded engagement, press-fit engagement, spring-pin engagement, bayonet coupling, or in any other suitable manner.
[0042] Referring in particular to FIGS. 3 and 4A, guide portion 522 of body 520 includes an outer wall 526, a lumen 528, a pair of slots 530, and a pair of engagement tabs 532. Outer wall 526 has a substantially cylindrical configuration and defines lumen 528 extending longitudinally therethrough. Lumen 528 is open at a proximal end of outer wall 526 and communicates with receiver portion 524 of body 520 at a distal end of outer wall 526. Further, guide portion 522 defines a proximal portion 529a wherein lumen 528 defines a first diameter and a distal portion 529b wherein lumen 528 defines a second, smaller diameter. Proximal portion 529a may extend a greater longitudinal extent of guide portion 522 as compared to distal portion 529b, e.g., wherein proximal portion 529a extends from about 60% to about 90% of a length of guide portion 522 while distal portion 529b extends from about 5% to about 20% of a length of guide portion 522, although other configurations are also contemplated. Slots 530 are defined through outer wall 526
at diametrically opposed positions such that slots 530 are aligned with one another. Slots 530 extend longitudinally along outer wall 526. Slots 530 are spaced from the proximal end of outer wall 526 and extend to the distal end of outer wall 526 to communicate with receiver portion 524 of body 520. Slots 530 communicate with lumen 528 and are configured to slidably receive rod 400 therein.
[0043] Engagement tabs 532 define cantilever configurations including fixed ends disposed towards the proximal end of guide portion 522 of body 520 with engagement tabs 532 extending distally and longitudinally therefrom along portions of slots 530 to free ends of engagement tabs 532. The free ends of each engagement tab 532 includes an engagement tooth 534 that extends inwardly through a corresponding slot 530 of guide portion 522 of body 520 and into lumen 528. Engagement teeth 534 define one-way ratchet configurations such as, for example, having a distal locking surface 535a extending substantially perpendicular relative to a longitudinal extent of body 520 and a proximal camming surface 535b angled relative to the longitudinal extent of body 520. Engagement tabs 532 are resiliently flexible from an initial position, wherein engagement teeth 534 extend radially inwardly into lumen 528, to a flexed position, wherein engagement teeth 534 are urged radially outwardly such that engagement teeth 534 are displaced from lumen 528 or extend into lumen 528 a lesser radial distance than in the initial position.
[0044] Referring in particular to FIGS. 3 and 4B, as noted above, receiver portion 524 of body 520 forms receiver 120 of screw assembly 100 (FIG. 1) upon detachment of guide portion 522 from receiver portion 524. Receiver portion 524 includes a base 538 and first and second opposing side walls 540 extending upwardly from base 538 in spaced relation relative to one another to define first and second opposing saddles 542. Saddles 542 align with and form distal end portions of slots 530 of guide portion 522 of body 520. Base 538 defines an internal cavity 543 open at a proximal end thereof (communicating with a volume defined between side walls 540) and at a distal end thereof (through a floor of base 538). Internal cavity 543 of base 538 is configured to receive head 112 of screw 110 therein. In aspects, head 112 of screw 110 is operably receivable within internal cavity 543 of base 538 of receiver portion 524 to permit angling of screw 110 relative to receiver portion 524 in at least one direction. In such aspects, head 112 of screw 110 and a portion of internal cavity 543 may define substantially spherical configurations to facilitate angling of screw 110 relative to receiver portion 524 in any suitable direction. In other aspects, head 112 of screw 110 is fixed relative to receiver portion 524 upon receipt therein such that screw
110 extends from receiver portion 524 at a fixed angle. In aspects, regardless of whether angulation of screw 110 relative to receiver portion 524 is permitted or inhibited, receiver 120 may be configured to rotate relative to screw 110, e.g., to re-orient a rod 400 (FIG. 1) received within receiver portion 524 relative to screw 110. Alternatively, receiver portion 524 may be rotationally fixed relative to screw 110.
[0045] Side walls 540 of receiver portion 524, as noted above, define saddles 542 therebetween. Saddles 542 define substantially U-shaped configurations and are configured to receive a rod 400 (FIG. 1) therethrough. Side walls 540 further include threading 544 defined on internal surfaces thereof. Threading 544 is configured to permit threaded engagement of set screw 130 within receiver portion 524 and between side walls 540 to thereby close the open proximal end of receiver portion 524 and retain rod 400 within saddles 542 while permitting sliding and/or rotation of rod 400 within saddles 542.
[0046] Continuing with reference to FIGS. 3 and 4B, the proximal ends of side walls 540 of receiver portion 524 of body 520 (opposite the base ends of side walls 540) are initially connected to (e.g., monolithically formed with) the distal end of outer wall 526 of guide portion 522 of body 520 to define transitions 546 therebetween. Further, the internal surface of outer wall 526 of distal portion 529b of guide portion 522 may define threading 548 that cooperates with threading 544 of side walls 540 of receiver portion 524 to define a continuous threaded region while guide portion 522 and receiver portion 524 remain connected to one another. Thus, set screw 130 may be inserted through lumen 528 of guide portion 522 and rotationally driven to engage threading 548 of outer wall 526 of distal portion 529b of guide portion 522 to thereby advance set screw 130 from guide portion 522 into engagement with threading 544 of side walls 540 of receiver portion 524 to retain rod 400 (and engage set screw 130) within saddles 542 of receiver portion 524. In other aspects, threading 548 of guide portion 522 is omitted (or not utilized) and set screw 130 is configured to be slid through guide portion 522 and into engagement with threading 544 of side walls 540 of receiver portion 524 to retain rod 400 therein.
[0047] Transition 546 defines a pre-determined break point wherein transition 546 breaks to thereby separate guide portion 522 from receiver portion 524. For example, transition 546 may be configured such that opposing inward forces applied from opposite sides of guide portion 522 break transition 546, thereby separating guide portion 522 from receiver portion 524. Instead of inward force, outward for may be applied to break transition. As another alternative, instead of
linear forces, torque may be applied to guide portion 522 to break transition 546 and separate guide portion 522 from receiver portion 524. With guide portion 522 separated from receiver portion 524 (regardless of the manner of breaking transition 546), side walls 540 of receiver portion 524 define free proximal ends. The separation of guide portion 522 from receiver portion 524 does not compromise the engagement of set screw 130 within receiver portion 524 and, thus, does not impact the retention of rod 400 within saddles 542 of receiver portion 524. As noted above, with guide portion 522 separated from receiver portion 524, receiver portion 524 defines receiver 120 of screw assembly 100 (see FIG. 1 and 9H).
[0048] Referring to FIGS. 2 and 5, insert 560 is substantially cylindrical and configured for slidable receipt within lumen 528 of guide portion 522. Further, insert 560 defines an internal lumen 562 extending longitudinally therethrough and a plurality of annular grooves 564 defined within an exterior surface of insert 560 and longitudinally spaced-apart along a portion of a length of insert 560. Internal lumen 562 of insert 560, in aspects, may be configured to receive set screw 130 therethrough to enable set screw 130 to be inserted through insert 560 when insert 560 is disposed within lumen 528 of guide portion 522 to position set screw 130 adjacent threading 548 of outer wall 526 of guide portion 522 to facilitate advancement of set screw 130 from guide portion 522 into threaded wengagement with threading 544 of side walls 540 of receiver portion 524 to retain rod 400 within saddles 542 of receiver portion 524 (see FIG. 4B).
[0049] Annular grooves 564 of insert 560 are configured to incrementally engage engagement teeth 534 of engagement tabs 532 as insert 560 is advanced through lumen 528 of guide portion 522 towards receiver portion 524, thereby defining a one-way way ratchet configuration wherein insert 560 is retained in position via engagement of engagement teeth 534 within an annular groove 564, wherein insert 560 is permitted to be advanced through lumen 528 of guide portion 522 towards receiver portion 524 with engagement teeth 534 incrementally moving from an annular groove 564 to a next annular groove 564, and wherein insert 560 is inhibited from being withdrawn from lumen 528 of guide portion 522 due to the engagement of engagement teeth 534 within an annular groove 564. Thus, with rod 400 extending through slots 530, insert 560 may be incrementally advanced (and retained in position) through guide portion 522 to thereby reduce rod 400 from guide portion 522 towards receiver portion 524.
[0050] With reference to FIGS. 1, 2, and 6, screw 110 includes a head 112 configured for receipt within receiver 120 and a shank 114 including threading 118 to facilitate driving of shank
114 into and retention of shank 114 within tissue, e.g., vertebral bone, although other configurations are also contemplated. Screw 110 may be formed from a metallic material such as, for example, titanium or cobalt chrome. Other suitable metallic materials forming screw 110 such as, for example, stainless steel, are also contemplated, as are configurations wherein screw 110 is formed from multiple materials, e.g., wherein head 112 is formed from a first material and wherein shank 114 is formed from a second, different material.
[0051] Rod 400 is shown in FIG. 7. Rod 400 may define a substantially cylindrical configuration of any suitable diameter and may be formed from a metallic material such as, for example, titanium or cobalt chrome, although other suitable metallic materials such as, for example, stainless steel, are also contemplated. With additional reference to FIG. 2, rod 400 is configured to be inserted transversely through slots 530 of guide portion 522 of body 520 and longitudinally reduced (e.g., under urging from insert 560) through guide portion 522 of body 520 into receiver portion 524 of body 520.
[0052] FIG. 8 illustrates set screw 130. Set screw 130 defines a generally cylindrical configuration and includes a body 132 and a cap 134. Body 132 includes threading 136 defined about an exterior annular surface of body 132. Referring also to FIGS. 2 and 4B, threading 136 is configured to enable threaded engagement of set screw 130 with threading 548 of guide portion 522 (in aspects where provided) and threading 544 of side walls 540 of receiver portion 524. Cap 134 of set screw 130 may be coupled to body 132 via a transition 138. In aspects, transition 138 defines a pre-determined break point wherein transition 138 breaks to thereby separate cap 134 from body 132. For example, as force (e.g., torque) applied to cap 134 reaches the pre-determined break point, transition 138 breaks, thereby separating cap 134 from body 132. In aspects, cap 134 defines a cavity (not explicitly shown) having a suitable geometric, e.g., hexagonal, star-shaped, etc., cross-section configured to facilitate engagement with an assembly tool (not shown), e.g., a rotational driver, to provide the torque input to cap 134 threadingly engage set screw 130 with threading 548 and/or threading 544 and to provide the input torque to reach the pre-determined break point for separating cap 134 from body 132. In other configurations, transition 138 is omitted such that cap 134 is not removable, or cap 134 may be omitted entirely. As noted above, in aspects, set screw 130 is insertable and advanceable through internal lumen 562 of insert 560. In other aspects, cap 134 is at least partially receivable within lumen 562 of insert 560 at a distal end of insert 560 and/or set screw 130 is configured to abut a distal end of insert 560. In these
configurations, insert 560 advances set screw 130 through guide portion 522 to urge set screw 130 into rod 400 to reduce rod 400. In such aspects, set screw 130 is advanced by insert 560 until set screw 130 is positioned adjacent threading 548 or threading 544, at which point set screw 130 may be rotationally driven (e.g., via rotational driving of insert 560 or a driver tool inserted through insert 560) to thereby engage set screw 130 with threading 548 and/or threading 544.
[0053] Turning to FIGS. 9A-9H, installation of rod reduction and receiver device 500 to operably couple a rod 400 to a screw 110 in accordance with the present disclosure is detailed. Initially, as shown in FIG. 9A, body 520 of device 500, led by receiver portion 524 thereof, is approximated relative to a head 112 of a screw 110 that has been anchored in a vertebra “V” of the patient’s spine “S” (see FIG. 1). More specifically, and with additional reference to FIG. 9B, body 520 of device 500 is approximated relative to head 112 of screw 110 such that head 112 of screw 110 is inserted through distal end of base 538 of receiver portion 524 and is captured within internal cavity 543 of receiver portion 524. In aspects, a bushing, pins, a collar, and/or any other suitable structure(s) (not shown) may be utilized to retain head 112 of screw 110 within internal cavity 543 of base 538 of receiver portion 524. As noted above, head 112 of screw 110 may be retained in fixed orientation or may be configured for angulation in at least one degree of freedom. [0054] With reference to FIG. 9C, once head 112 of screw 110 is engaged within receiver portion 524 of body 520 of device 500, rod 400 is inserted transversely through slots 530 of guide portion 522 of body 520 such that rod 400 extends through body 520, e.g., across lumen 528 thereof.
[0055] Referring to FIG. 9D, with rod 400 received through guide portion 522 of body 520, insert 560 may be inserted into lumen 528 of guide portion 522. Referring also to FIG. 9E, insert 560 is incrementally advanced through guide portion 522 of body 520 via the one-way ratcheting engagement of engagement teeth 534 within annular grooves 564 (see also FIGS. 4A and 5) to thereby reduce rod 400 towards receiver portion 524 of body 520.
[0056] With reference to FIGS. 9F and 9G, once rod 400 is reduced to or adjacent to the final position, e.g., within saddles 542 of receiver portion 524 of body 520, set screw 130 is inserted through insert 560 and threadingly advanced into and/or along side walls 540 of receiver portion 524 of body 520 to thereby further urge rod 400 to the final position (if necessary) and retain rod 400 within saddles 542 of receiver portion 524 of body 520, as shown in FIG. 9G (wherein insert 560 has been removed for illustration purposes). At the final position of set screw 130, transition
138 may break to thereby separate cap 134 of set screw 130 from body 132 of set screw 130 such that cap 134 may be removed.
[0057] As shown in FIG. 9H, with set screw 130 in place (as detailed above), guide portion 522 (including insert 560 therein) may be separated from receiver portion 524 and removed, thus leaving the fully assembled screw assembly 100 including screw 110 (anchored in a vertebra “V” of the patient’s spine “S” (FIG. 1)), receiver 120 (defined by the separated receiver portion 524 of body 520, operably coupled to screw 110, and receiving rod 400 therethrough), and set screw 130 (retaining rod 400 within receiver 120).
[0058] Turning to FIG. 10, another rod reduction and receiver device provided in accordance with the present disclosure is shown generally identified by reference numeral 1000. Device 1000 includes a body 1020 and an insert 1060. Body 1020 is configured to operably couple to a screw 110, to receive a rod 400, to operably receive insert 1060 to facilitate reduction of rod 400 relative to screw 110, and to facilitate operable engagement of a set screw (not shown) with a portion of body 1020 to operably couple rod 400 with screw 110.
[0059] Body 1020 includes a guide portion 1022 and a receiver portion 1024 and is configured similar to body 520 of device 500 (FIG. 2) except as explicitly contradicted below. Accordingly, differences between device 1000 and device 500 (FIG. 2) are described in detail below while similarities are summarily described or omitted entirely for purposes of brevity.
[0060] Guide portion 1022, rather than including engagement tabs having engagement teeth as detailed above with respect to 500 (FIG. 2), includes internal threading 1032 defined on the interior annular surface portions of outer wall 1026 of proximal portion 1029a of guide portion 1022. Further, rather than insert 1060 including annular grooves as detailed above with respect to 500 (FIG. 2), insert 1060 includes threading 1064 defined on the annular exterior surface thereof that is configured to engage threading 1032 of proximal portion 1029a of guide portion 1022 of body 1020 upon insertion of insert 1060 into guide portion 1022 of body 1020. Thus, rather than a one-way ratchet configuration as detailed above with respect to 500 (FIG. 2), device 1000 enables a threaded engagement between insert 1060 and guide portion 1022 of body 1020 to reduce rod 400 to a desired position, e.g., within receiver portion 1024 of body 1020.
[0061] In aspects, threading 1032 of proximal portion 1029a of guide portion 1022 of body 1020 defines a different pitch compared to the threading (if provided) of distal portion 1029b of guide portion 1022 and/or the threading of receiver portion 1024. In particular, the pitch of
threading 1032 may be steeper than the threadings of distal portion 1029b of guide portion 1022 and/or receiver portion 1024 such that insert 1060 is capable of being advanced more rapidly through guide portion 1022 of body 1020 to reduce rod 400 more quickly while threaded engagement of the set screw 130 with receiver portion 1024 of body 1020 can be more finely controlled via the relatively shallower threadings of distal portion 1029b of guide portion 1022 and/or receiver portion 1024. Further, the relatively larger diameter proximal portion 1029a of guide portion 1022 of body 1020 enables slidable passage of the set screw therethrough without engagement of threads, while, due to the relatively smaller diameter of distal portion 1029b of guide portion 1022, set screw is threadingly engaged therein and is required to be rotated to advance the set screw through the distal portion 1029b of guide portion 1022 and into receiver portion 1024.
[0062] Continuing with reference to FIG. 10, the set screw may be inserted through insert 1060 of device 1000 to threadingly engage receiver portion 1024 of body 1020 to operably retain rod 400 therein. Alternatively, the set screw may be at least partially receivable within an internal lumen of insert 1060 or disposed at a distal end of insert 1060 such that insert 1060 advances the set screw through guide portion 1022 to urge the set screw into rod 400 to reduce rod 400. In other aspects, the set screw is part of a set screw assembly, similarly as detailed below. Regardless of the particular configuration, insert 1060 may define a cavity 1068 having a suitable geometric, e.g., hexagonal, star-shaped, etc., cross-section configured to facilitate engagement with an assembly tool (not shown), e.g., a rotational driver, to provide torque input to insert 1060 to threadingly advance insert 1060 through guide portion 1022 of body 1020 and to threadingly engage the set screw with the threading of receiver portion 1024 of body 1020.
[0063] Turning to FIGS. 11-15B, another rod reduction and receiver device provided in accordance with the present disclosure is shown generally identified by reference numeral 1100. Device 1100 includes a body 1120 and a set screw assembly 1180. Body 1120 is configured to operably couple to a screw 110, to receive a rod 400, to operably receive set screw assembly 1180 to facilitate reduction of rod 400 relative to screw 110, and to facilitate operable engagement of a distal screw portion 1190 of set screw assembly 1180 with a receiver portion 1124 of body 1120 to operably couple rod 400 with screw 110.
[0064] Body 1120 includes a guide portion 1122 and a receiver portion 1124. Guide portion 1122 is similar to and includes the features of guide portion 1022 of device 1000 (FIG. 10). That
is, guide portion 1122 includes an outer wall 1126, a lumen 1128, and a pair of opposed slots 1130. Guide portion 1122 defines a proximal portion 1129a, wherein lumen 1128 defines a first diameter and wherein outer wall 1126 includes internal threading 1132 defined on the interior annular surface portions thereof, and a distal portion 1129b, wherein lumen 1128 has a second diameter and outer wall 1126 includes internal threading 1148 of a second pitch. In aspects, the first diameter is larger than the second diameter and the first pitch is steeper than the second pitch. Guide portion 1122 of body 1120 may otherwise be similar to and include any of the features of guide portion 522 of body 520 of device 500 (FIG. 2).
[0065] Receiver portion 1124 of body 1120 forms receiver 120 of screw assembly 100 (FIG. 1) upon detachment of guide portion 1122 from receiver portion 1124. Receiver portion 1124 is similar to and may include any of the features of receiver portion 524 of body 520 of device 500 (FIG. 2).
[0066] Referring to FIGS. 12 and 13, in conjunction with FIGS. 11 and 14-15B, set screw assembly 1180 includes a body 1182, an alignment collar 1184, and a retention ring 1186. Body 1182 includes a proximal screw portion 1188, a distal screw portion 1190, and a central portion 1192 connecting proximal and distal screw portions 1188, 1190 with one another. Alignment collar 1184 includes a base 1194 rotatably disposed about central portion 1192 of body 1182 and first and second arms 1196 extending from base 1194 distally on either side of distal screw portion 1190. Retention ring 1186 is engaged, e.g., welded or otherwise fixed, to central portion 1192 of body 1182 to rotatably retain alignment collar 1184 about central portion 1192 of body 1182 between retention ring 1186 and a proximal annular protrusion 1198 of central portion 1192.
[0067] Proximal screw portion 1188 of set screw assembly 1180 defines a first diameter and includes first threading 1189 while distal screw portion 1190 defines a second diameter and includes second threading 1191. First diameter and first threading 1189 are configured to enable threaded engagement of proximal screw portion 1188 with threading 1132 of proximal portion 1129a of guide portion 1122 of body 1120. Second diameter and second threading 1191 are configured such that distal screw portion 1190 slides through proximal portion 1129a of guide portion 1122 of body 1120 (without threaded engagement therewith) and is configured to enable threaded engagement of distal screw portion 1190 with threading 1148 of distal portion 1129b of guide portion 1122 of body 1120 and threading 1144 of receiver portion 1124. In aspects, threadings 1132, 1189 define steeper pitches compared to threadings 1148, 1191 (and threading
1144), thus enabling faster advancement of set screw assembly 1180 through proximal portion 1129a of guide portion 1122 of body 1120 and more controlled or fine-tuned advancement of set screw assembly 1180 through distal portion 1129b of guide portion 1122 of body 1120 and receiver portion 1124 of body 1120.
[0068] A first transition 1193a is defined between central portion 1192 and distal screw portion 1190 and a second transition 1193b is defined between a cap 1200 of distal screw portion 1190 and a threaded portion 1202 (which includes threading 1191) of distal screw portion 1190. The breaking threshold of first transition 1193a is less than that of second transition 1193b such that first transition 1193a breaks first to separate distal screw portion 1190 from the remainder of body 1182 of set screw assembly 1180. Thereafter, upon application of increased force, e.g., torque, second transition 1193b breaks to separate cap 1200 of distal screw portion 1190 from threaded portion 1202 (which includes threading 1191) of distal screw portion 1190.
[0069] Set screw assembly 1180 is operably positioned within lumen 1128 of body 1120 of device 1100 and, initially, is disposed towards the proximal end of body 1120. With set screw assembly 1180 positioned within lumen 1128 of body 1120, first and second arms 1196 of alignment collar 1184 extend at least partially into slots 1130 of guide portion 1122 of body 1120 to rotationally fix alignment collar 1184 relative to guide portion 1122 while permitting sliding of alignment collar 1184 (and, thus, set screw assembly 1180) through guide portion 1122. The free ends of first and second arms 1196 of alignment collar 1184 may define semi-circular cut outs 1199 configured to receive and at least partially conform about rod 400 when rod 400 extends through guide portion 1122 of body 1120.
[0070] With reference to FIGS. 11, 14, 15A, and 15B, installation of rod reduction and receiver device 1100 to operably couple a rod 400 to a screw 110 in accordance with the present disclosure is detailed. Initially, as noted above and as shown in FIG. 11, set screw assembly 1180 is operably positioned within lumen 1128 of body 1120 of device 1100 towards the proximal end of body 1120. In aspects, set screw assembly 1180 is operably positioned within the proximal end of lumen 1128 during manufacturing. In this position, body 1120 of device 1100, led by receiver portion 1124 thereof, is approximated relative to a head 112 of a screw 110 that has been anchored in a vertebra “V” of the patient’s spine “S” (see FIG. 1) to retain head 112 of screw 110 within the internal cavity defined by receiver portion 1124, similarly as detailed above.
[0071] Next, rod 400 is inserted transversely through slots 1130 of guide portion 1122 of body 1120 such that rod 400 extends through body 1120, e.g., across lumen 1128 thereof, at a position distal of set screw assembly 1180. With rod 400 received through guide portion 1122 of body 1120, set screw assembly 1180 may be advanced distally through proximal portion 1129a of guide portion 1122 to thereby reduce rod 400. More specifically, an assembly tool (not shown), e.g., a rotational driver, may be engaged within a cavity of body 1182 of set screw assembly 1180 and rotationally driven to rotate body 1182 of set screw assembly 1180 relative to guide portion 1122 of body 1120 such that set screw assembly 1180 is advanced distally via the threaded engagement of first threading 1189 of proximal screw portion 1188 with threading 1132 of proximal portion 1129a of guide portion 1122 of body 1120. As set screw assembly 1180 is advanced distally, free ends of first and second arms 1196 of alignment collar 1184 slide through slots 1130 and contact rod 400 (e.g., partially receiving rod 400 within semi-circular cut outs 1199) to thereby urge rod 400 distally, reducing rod 400 towards receiver portion 1124 of body 1120. Further, due to the smaller diameter of distal screw portion 1190 compared to lumen 1128 within proximal portion 1129a of guide portion 1122 of body 1120, distal screw portion 1190 is translated through lumen 1128 without contacting guide portion 1122.
[0072] As rod 400 is reduced, distal screw portion 1190 is eventually moved from proximal portion 1129a of guide portion 1122 to distal portion 1129b of guide portion 1122, wherein threading 1191 of distal screw portion 1190 threadingly engages threading 1148 of distal portion 1129b of guide portion 1122. Further rotational driving of set screw assembly 1180 continues to reduce rod 400 via distal advancement of set screw assembly 1180. Proximal screw portion 1188 may bottom out within proximal portion 1129a of guide portion 1122 and/or may otherwise be configured to encounter greater resistance once or shortly after threading 1191 of distal screw portion 1190 threadingly engages threading 1148 of distal portion 1129b of guide portion 1122 such that further torquing set screw assembly 1180 breaks first transition 1193 a to thereby separate distal screw portion 1190 from the remainder of body 1182 of set screw assembly 1180.
[0073] With distal screw portion 1190 separated from the remainder of set screw assembly 1180, distal screw portion 1190 may be further rotationally driven (while the remainder of set screw assembly 1180 remains in position) to advance distal screw portion 1190 from distal portion 1129b of guide portion 1122 into receiver portion 1124 of body 1120 to threadingly engage threading 1144 of receiver portion 1124 sufficiently so as to urge rod 400 into position within
receiver portion 1124 and retain rod 400 within receiver portion 1124 via the engagement of distal screw portion 1190 therein.
[0074] At the final position of distal screw portion 1190, second transition 1193b may break to separate cap 1200 of distal screw portion 1190 from threaded portion 1202 of distal screw portion 1190 such that cap 1200 may be removed. Further, with additional momentary reference to FIG. 1, with distal screw portion 1190 in place (as detailed above), guide portion 1122 (including the separated portion of set screw assembly 1180 retained therein) may be separated from receiver portion 1124 and removed, thus leaving the fully assembled screw assembly 100 including screw 110 (anchored in a vertebra “V” of the patient’s spine “S”), receiver 120 (formed by the separated receiver portion 1124, operably coupled to screw 110, receiving rod 400 therethrough), and distal screw portion 1190 (functioning as the set screw) retaining rod 400 within receiver 120.
[0075] Turning to FIG. 16, still yet another rod reduction and receiver device provided in accordance with the present disclosure is shown generally identified by reference numeral 1600. Device 1600 is similar to device 1100 (FIGS. 11-15B) and, thus, only differences therebetween are described in detail below while similarities are summarily described or omitted entirely for purposes of brevity.
[0076] Device 1600 includes a body 1620 and a set screw assembly 1680. Body 1620 includes a guide portion 1622 and a receiver portion 1624. Guide portion 1622 defines a proximal portion 1629a, wherein lumen 1628 defines a first diameter and wherein outer wall 1626 includes annular ratchet teeth 1632 defined on the interior annular surface portions thereof and extending longitudinally therealong, and a distal portion 1629b, wherein lumen 1628 has a second, smaller diameter and threading 1648.
[0077] Set screw assembly 1680 includes a body 1682 having a proximal ratchet portion 1688, a distal screw portion 1690, and a central portion 1692 connecting proximal ratchet portion 1688 and distal screw portion 1190 with one another. First and second transitions 1693a, 1693b are defined between central portion 1692 and distal screw portion 1690 and portions of distal screw portion 1690, similarly as detailed above with respect to set screw assembly 1180 (FIGS. 12 and 13).
[0078] Proximal ratchet portion 1688 of set screw assembly 1680 defines a first diameter and includes an annular pawl 1689 while distal screw portion 1690 defines a second diameter and includes threading 1691. First diameter and annular pawl 1689 are configured to enable
incremental one-way ratcheting engagement of proximal ratchet portion 1688 with annular ratchet teeth 1632 of proximal portion 1629a of guide portion 1622 of body 1620 to thereby enable incremental advancement of set screw assembly 1680 through proximal portion 1629a of guide portion 1622 of body 1620. Second diameter and second threading 1691 are configured such that distal screw portion 1690 slides through proximal portion 1629a of guide portion 1622 of body 1620 (without engagement therewith) and is configured to enable threaded engagement of distal screw portion 1690 with threading 1648 of distal portion 1629b of guide portion 1622 of body 1120 and into threaded engagement within receiver portion 1624 of body 1620.
[0079] Thus, device 1600 operates similar to device 1100 (FIGS. 11-15B) except that, rather than threaded engagement and advancement of the set screw assembly through the proximal portion of the guide portion of the body as with device 1100 (FIGS. 11-15B), proximal ratchet portion 1688 of set screw assembly 1680 of device 1600 is configured for one-way ratcheting engagement and incremental advancement through proximal portion 1629a of guide portion 1622 of body 1620.
[0080] Referring to FIG. 17A-17D, in aspects where a plurality of rod reduction and receiver devices 1700 in accordance with the present disclosure are utilized to reduce a rod 400 relative to a plurality of screws 110 and to operably couple rod 400 with the plurality of screws 110, rod 400 need not be actively reduced within each device 1700, thereby saving installation time. For example, in aspects, rod 400 may first be fed through each of the plurality of devices 1700. Thereafter, some (but not all) of the devices 1700 may be utilized to reduce rod 400 into position or adjacent to a final position thereof. For example, active reduction according to any of the aspects detailed hereinabove may be performed on alternating devices 1700 along rod 400, every third device 1700 along rod 400, or in any other suitable manner. Once rod 400 is sufficiently reduced, set screws (not explicitly shown) may first be installed on the devices 1700 that were not actively reduced to retain rod 400 in position within those devices 1700. Thereafter, set screws may be installed on the devices 1700 that actively reduced to retain rod 400 in position within those devices 1700. Finally, the removable portion of devices 1700 may be removed, leaving being a plurality of screw assemblies 100 coupling rod 400 with the plurality of screws 110 along the length of rod 400.
[0081] Examples:
[0082] Example 1. A rod reduction and receiver device, comprising:
a guide portion including an outer wall surrounding a lumen extending longitudinally through the guide portion and first and second slots defined transversely through the outer wall to communicate with the lumen, the guide portion configured to receive a rod transversely across the lumen and through the first and second slots and to facilitate reduction of the rod relative to the guide portion; a receiver portion including a base and first and second side walls extending from the base to define first and second saddles between the first and second side walls, the base configured to operably receive a head of a screw, the first and second saddles configured to receive the rod upon reduction of the rod from the guide portion into the receiver portion; and a set screw assembly movable through the lumen of the guide portion, the set screw assembly including an alignment collar configured to extend at least partially into the first and second slots of the guide portion and to slide through the first and second slots to reduce the rod towards the receiver portion. [0083] Example 2. The rod reduction and receiver device according to example 1, wherein the set screw assembly further includes a body having a proximal portion configured for operable engagement with the guide portion to facilitate reduction of the rod from the guide portion into the receiver portion and a distal portion configured for operable engagement with the receiver portion to retain the rod within the first and second saddles after reduction of the rod into the receiver portion.
[0084] Example 3. The rod reduction and receiver device according to example 2, wherein the proximal portion of the body of the set screw assembly is configured for threaded engagement with the guide portion such that rotational driving of the proximal portion of the set screw assembly relative to the guide portion reduces the rod relative to the guide portion.
[0085] Example 4. The rod reduction and receiver device according to example 2, wherein the proximal portion of the body of the set screw assembly and the guide portion cooperate to define a one-way rachet mechanism for incremental advancement of the set screw assembly through the lumen of the guide portion to incrementally reduce the rod relative to the guide portion.
[0086] Example 5. The rod reduction and receiver device according to any one of examples 2- 4, wherein the distal portion of the body of the set screw assembly is configured for threaded engagement within the receiver portion to retain the rod within the first and second saddles after reduction of the rod into the receiver portion.
[0087] Example 6. The rod reduction and receiver device according to any one of examples 2-
5, wherein the alignment collar of the set screw assembly is rotatably coupled to the body of the set screw assembly.
[0088] Example 7. The rod reduction and receiver device according to any one of examples 2-
6, wherein the proximal and distal portions of the body of the set screw assembly are removably connected to one another.
[0089] Example 8. The rod reduction and receiver device according to example 7, wherein the proximal and distal portions of the body of the set screw assembly are initially monolithically formed defining a transition therebetween, and wherein the transition is configured to break to separate the proximal and distal portions of the body of the set screw assembly from one another. [0090] Example 9. The rod reduction and receiver device according to any preceding example, wherein the alignment collar of the set screw assembly includes a base slidable within the lumen of the guide portion and first and second arms slidable through the first and second slots of the guide portion.
[0091] Example 10. The rod reduction and receiver device according to example 9, wherein the first and second arms define proximal ends attached to the base of the alignment collar and free distal ends configured to contact the rod to reduce the rod towards the receiver portion.
[0092] Example 11. The rod reduction and receiver device according to example 10, wherein the free distal ends of the first and second arms of the alignment collar are configured to partially receive the rod within cut-outs defined therein.
[0093] Example 12. The rod reduction and receiver device according to any preceding example, wherein the guide portion and the receiver portion are removably connected to one another.
[0094] Example 13. The rod reduction and receiver device according to example 12, wherein the guide portion and the receiver portion are initially monolithically formed as the body defining at least one transition therebetween, and wherein the at least one transition is configured to break to separate the receiver portion from the guide portion.
[0095] Example 14. A spinal surgical system, comprising: a rod; a screw defining a head and a shank extending from the head; and
the rod reduction and receiver device according to any preceding claim.
[0096] Example 15. A spinal surgical system, comprising: a rod; a plurality of screws, each screw defining a head and a shank extending from the head; and a plurality of the rod reduction and receiver devices according to any preceding example.
[0097] While several aspects of the disclosure have been detailed above and are shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description and accompanying drawings should not be construed as limiting, but merely as exemplifications of particular aspects. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. 1
Claims
1. A rod reduction and receiver device, comprising: a guide portion (1122, 1622) including an outer wall (1126, 1626) surrounding a lumen (1128, 1628) extending longitudinally through the guide portion (1122, 1622) and first and second slots (1130 1630) defined transversely through the outer wall (1126, 1626) to communicate with the lumen (1128, 1628), the guide portion (1122, 1622) configured to receive a rod (400) transversely across the lumen (1128, 1628) and through the first and second slots (1130 1630) and to facilitate reduction of the rod (400) relative to the guide portion (1122, 1622); and a receiver portion (1124, 1624) including a base (538) and first and second side walls (540) extending from the base (538) to define first and second saddles (542) between the first and second side walls (540), the base (538) configured to operably receive a head (112) of a screw (110), the first and second saddles (542) configured to receive the rod (400) upon reduction of the rod (400) from the guide portion (1122, 1622) into the receiver portion (1124, 1624), characterized by a set screw assembly (1180, 1680) movable through the lumen (1128, 1628) of the guide portion (1122, 1622), the set screw assembly (1180, 1680) including an alignment collar (1184) configured to extend at least partially into the first and second slots (1130 1630) of the guide portion (1122, 1622) and to slide through the first and second slots (1130 1630) to reduce the rod (400) towards the receiver portion (1124, 1624).
2. The rod reduction and receiver device according to claim 1 , wherein the set screw assembly (1180, 1680) further includes a body (1182, 1682) having a proximal portion (1188, 1688) configured for operable engagement with the guide portion (1122, 1622) to facilitate reduction of the rod (400) from the guide portion (1122, 1622) into the receiver portion (1124, 1624) and a distal portion (1190, 1690) configured for operable engagement with the receiver portion (1124, 1624) to retain the rod (400) within the first and second saddles (542) after reduction of the rod (400) into the receiver portion (1124, 1624).
3. The rod reduction and receiver device according to claim 2, wherein the proximal portion (1188) of the body (1182) of the set screw assembly (1180) is configured for threaded engagement with the guide portion (1122) such that rotational driving of the proximal portion (1188) of the set screw
assembly (1180) relative to the guide portion (1122) reduces the rod (400) relative to the guide portion (1122).
4. The rod reduction and receiver device according to claim 2, wherein the proximal portion (1688) of the body (1682) of the set screw assembly (1680) and the guide portion (1622) cooperate to define a one-way rachet mechanism for incremental advancement of the set screw assembly (1680) through the lumen (1628) of the guide portion (1622) to incrementally reduce the rod (400) relative to the guide portion (1622).
5. The rod reduction and receiver device according to any one of claims 2-4, wherein the distal portion (1190, 1690) ofthe body (1182, 1682) ofthe set screw assembly (1180, 1680) is configured for threaded engagement within the receiver portion (1124, 1624) to retain the rod (400) within the first and second saddles (542) after reduction of the rod (400) into the receiver portion (1124, 1624).
6. The rod reduction and receiver device according to any one of claims 2-5, wherein the alignment collar (1184) of the set screw assembly (1180, 1680) is rotatably coupled to the body (1182, 1682) of the set screw assembly (1180, 1680).
7. The rod reduction and receiver device according to any one of claims 2-6, wherein the proximal (1188, 1688) and distal portions (1190, 1690) of the body (1182, 1682) of the set screw assembly (1180, 1680) are removably connected to one another.
8. The rod reduction and receiver device according to claim 7, wherein the proximal (1188, 1688) and distal portions (1190, 1690) of the body of the set screw assembly (1180, 1680) are initially monolithically formed defining a transition (1193a, 1693a) therebetween, and wherein the transition (1193a, 1693a) is configured to break to separate the proximal (1188, 1688) and distal portions (1190, 1690) of the body (1182, 1682) of the set screw assembly (1180, 1680) from one another.
9. The rod reduction and receiver device according to any preceding claim, wherein the alignment collar (1184) of the set screw assembly (1180, 1680) includes a base (1194) slidable within the lumen (1128, 1628) of the guide portion (1122, 1622) and first and second arms (1196) slidable through the first and second slots (1130, 1630) of the guide portion (1122, 1622).
10. The rod reduction and receiver device according to claim 9, wherein the first and second arms (1196) define proximal ends attached to the base (1194) of the alignment collar (1184) and free distal ends configured to contact the rod (400) to reduce the rod (400) towards the receiver portion (1124, 1624).
11. The rod reduction and receiver device according to claim 10, wherein the free distal ends of the first and second arms (1196) of the alignment collar (1184) are configured to partially receive the rod (400) within cut-outs (1199) defined therein.
12. The rod reduction and receiver device according to any preceding claim, wherein the guide portion (1122, 1622) and the receiver portion are removably connected to one another.
13. The rod reduction and receiver device according to claim 12, wherein the guide portion (1122, 1622) and the receiver portion (1124, 1624) are initially monolithically formed as the body (1120, 1620) defining at least one transition (546) therebetween, and wherein the at least one transition (546) is configured to break to separate the receiver portion (1124, 1624) from the guide portion (1122, 1622).
14. A spinal surgical system, comprising: a rod (400); a screw (110) defining a head (112) and a shank (114) extending from the head (112); and the rod reduction and receiver device (1100, 1600) according to any preceding claim.
15. A spinal surgical system, comprising: a rod (400); a plurality of screws (110), each screw (110) defining a head (112) and a shank (114) extending from the head (112); and a plurality of the rod reduction and receiver devices (1100, 1600) according to any preceding claim.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202463626097P | 2024-01-29 | 2024-01-29 | |
| US63/626,097 | 2024-01-29 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025163480A1 true WO2025163480A1 (en) | 2025-08-07 |
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ID=94633611
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2025/050913 Pending WO2025163480A1 (en) | 2024-01-29 | 2025-01-28 | Devices facilitating spinal rod reduction |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025163480A1 (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110166606A1 (en) * | 2008-09-12 | 2011-07-07 | Synthes Usa, Llc | Reduction tool |
| US20150230836A1 (en) * | 2011-04-05 | 2015-08-20 | Scott Cochran | Screw and rod fixation system |
| US20150351810A1 (en) * | 2013-03-22 | 2015-12-10 | Aesculap Ag | Vertebral column-stabilizing system and surgical fastening element for a vertebral column-stabilizing system |
| US20170007302A1 (en) * | 2012-08-03 | 2017-01-12 | Alphatec Spine, Inc. | Instrument and method for reducing and securing spinal rods |
-
2025
- 2025-01-28 WO PCT/IB2025/050913 patent/WO2025163480A1/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110166606A1 (en) * | 2008-09-12 | 2011-07-07 | Synthes Usa, Llc | Reduction tool |
| US20150230836A1 (en) * | 2011-04-05 | 2015-08-20 | Scott Cochran | Screw and rod fixation system |
| US20170007302A1 (en) * | 2012-08-03 | 2017-01-12 | Alphatec Spine, Inc. | Instrument and method for reducing and securing spinal rods |
| US20150351810A1 (en) * | 2013-03-22 | 2015-12-10 | Aesculap Ag | Vertebral column-stabilizing system and surgical fastening element for a vertebral column-stabilizing system |
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