Devices and systems for treating spinal disorders

The connector assembly for spinal surgical systems addresses the need for frequent revisions by allowing efficient extension or adjustment of spinal rods, reducing the need for additional invasive surgeries and enhancing surgical efficiency.

WO2025074296A1PCT designated stage expired Publication Date: 2025-04-10WARSAW ORTHOPEDIC INC
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Patent Information

Application Number
PCT/IB2024/059679
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-10-06
Filing Date
2024-10-03
Publication Date
2025-04-10

AI Technical Summary

Technical Problem

Existing spinal surgical systems require additional surgical interventions to extend, adjust, or revise previously implanted systems of rods and screws, which can be cumbersome and invasive.

Method used

A connector assembly for spinal surgical systems, comprising a set screw, a connector with a rod portion and a head portion, and a nut, designed to couple with a screw assembly and allow for the extension or adjustment of rods while maintaining stability and alignment.

Benefits of technology

Enables efficient extension or adjustment of spinal rods without the need for additional invasive surgeries, providing a more streamlined and less invasive method for revising spinal surgical systems.

✦ Generated by Eureka AI based on patent content.

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Abstract

A connector configured for use with a spinal surgical system includes a rod portion defining a longitudinal axis and a head portion integrally connected to the rod portion. The head portion has a transverse bore defined therethrough and a longitudinal cut out defined therein. The transverse bore defines a first axis substantially perpendicular to the longitudinal axis and configured to enable coupling of the head portion to a screw assembly. The longitudinal cut out defines a second axis substantially parallel to or substantially coaxial with the longitudinal axis and configured to receive a portion of a rod therein such that the portion of the rod is substantially parallel to or substantially coaxial with the rod portion. A connection assembly include the connector, a set screw, and a nut. A spinal surgical system includes the connection assembly, a screw assembly, and a rod.
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Description

DEVICES AND SYSTEMS FOR TREATING SPINAL DISORDERSFIELD

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 588,312, filed 6 October 2023, the entire content of which is incorporated herein by reference.

[0002] The present disclosure relates to spinal surgery and, more particularly, to devices and systems for treating disorders of the spine.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, additional surgical intervention(s) may be required in some instances to extend, adjust, and / or otherwise revise the previously implanted 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 connector configured for use with a spinal surgical system. The connector includes a rod portion defining a longitudinal axis and a head portion integrally connected to the rod portion. The head portion has a transverse bore defined therethrough and a longitudinal cut out defined therein. The transverse bore defines a first axis substantially perpendicular to the longitudinal axis of the rodportion and configured to enable coupling of the head portion to a screw assembly. The longitudinal cut out defines a second axis substantially parallel to or substantially coaxial with the longitudinal axis of the rod portion and configured to receive a portion of a rod therein such that the portion of the rod is substantially parallel to or substantially coaxial with the rod portion.

[0008] In an aspect of the present disclosure, the head portion defines a first face and a second face. The first face includes a planar surface extending to a concave surface. The concave surface extends from the planar surface to the rod portion.

[0009] In another aspect of the present disclosure, the second face includes a convex surface. In aspects, the concave surface defines a radius of curvature less than a radius of curvature of the convex surface.

[0010] In yet another aspect of the present disclosure, the transverse bore extends from the planar surface on the first face to the convex surface on the second face.

[0011] In still another aspect of the present disclosure, the longitudinal cut out is open along a convex surface of the head portion to enable insertion of the portion of the rod into the longitudinal cut out in a direction perpendicular to a longitudinal axis of the portion of the rod.

[0012] In still yet another aspect of the present disclosure, the head portion includes first and second opposing faces interconnected by first and second opposing sides. The first and second opposing sides taper inwardly towards one another in a direction from the head portion towards the rod portion.

[0013] A connector assembly configured for use with a spinal surgical system and provided in accordance with the present disclosure includes a set screw configured to engage a receiver of a screw assembly, a connector, and a nut. The connector includes a rod portion defining a longitudinal axis and a head portion integrally connected to the rod portion. The head portion has a transverse bore configured to receive the set screw to position the head portion of the connector about the set screw. The head portion further has a longitudinal cut out defined therein configured to receive a portion of a rod therein and defining an axis substantially parallel to or substantially coaxial with the longitudinal axis of the rod portion such that the portion of the rod received within the longitudinal cut out is substantially parallel to or substantially coaxial with the rod portion. The nut is configured to engage the set screw to thereby retain the head portion of the connector between the nut and the screw assembly.

[0014] In an aspect of the present disclosure, the set screw includes first threading configured to engage corresponding threading of the receiver of the screw assembly and second threading configured to engage corresponding threading of the nut.

[0015] In another aspect of the present disclosure, the head portion of the connector defines a first face and a second face. The first face includes a planar surface extending to a concave surface. The concave surface extends from the planar surface to the rod portion. The second face includes a convex surface. In aspects, the concave surface defines a radius of curvature less than a radius of curvature of the convex surface.

[0016] In still another aspect of the present disclosure, the planar surface is configured to face the nut and the convex surface is configured to face the screw assembly.

[0017] In yet another aspect of the present disclosure, the longitudinal cut out is open along a convex surface of the head portion to enable positioning of the portion of the rod within the longitudinal cut out in a direction perpendicular to a longitudinal axis of the portion of the rod.

[0018] A spinal surgical system provided in accordance with aspects of the present disclosure includes a rod, a screw assembly, and a connector assembly. The screw assembly includes a screw and a receiver coupled to the screw. The screw is configured for engagement within spinal bone of a patient and the receiver is configured to receive the rod. The connector assembly is configured to engage the screw assembly and includes a set screw, a connector, and a nut. The set screw is configured to engage the receiver of the screw assembly to retain the rod within the receiver. The connector includes a rod portion defining a longitudinal axis and a head portion integrally connected to the rod portion. The head portion has a transverse bore configured to receive the set screw to couple the connector to the screw assembly. The head portion further has a longitudinal cut out defined therein and configured to receive a portion of the rod therein such that the rod and the rod portion are substantially parallel to or substantially coaxial with one another. The nut is configured to engage the set screw to thereby retain the connector coupled to the screw assembly.

[0019] In an aspect of the present disclosure, a head of the screw is operably received within the receiver to enable angulation of the receiver relative to the screw.

[0020] In another aspect of the present disclosure, the receiver is configured to receive a head of the screw on one side of the rod and the set screw on a second, opposite side of the rod.

[0021] In still another aspect of the present disclosure, the set screw includes first threading configured to engage corresponding threading of the receiver of the screw assembly and second threading configured to engage corresponding threading of the nut.

[0022] In yet another aspect of the present disclosure, the head portion of the connector defines a first face and a second face. The first face includes a planar surface extending to a concave surface. The concave surface extends from the planar surface to the rod portion. The second face includes a convex surface. In aspects, the concave surface defines a radius of curvature less than a radius of curvature of the convex surface.

[0023] In still another aspect of the present disclosure, the longitudinal cut out is open along a convex surface of the head portion to enable positioning of the portion of the rod within the longitudinal cut out in a direction perpendicular to a longitudinal axis of the portion of the rod.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] 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.

[0025] FIG. 1 shows a system for treating disorders of the spine in accordance with the present disclosure installed on a patient’s spine;

[0026] FIG. 2 is a perspective view of a connector assembly provided in accordance with the present disclosure operably coupled to a screw assembly and rod of the system of FIG. 1 in accordance with the present disclosure;

[0027] FIGS. 3 A and 3B are side views of the connector assembly of FIG. 2 operably coupled to the screw assembly and rod with and without a nut of the connector assembly, respectively;

[0028] FIG. 4 is an exploded, perspective view of the connector assembly of FIG. 2;

[0029] FIG. 5 is a perspective view of a connector of the connector assembly of FIG. 2;

[0030] FIGS. 6A-6C are top, bottom, and longitudinal cross-sectional views, respectively, of a head end portion of the connector of FIG. 5 ;

[0031] FIG. 7A is a side view of a set screw of the connector assembly of FIG. 2;

[0032] FIG. 7B is a cross-sectional view taken along section line “7B-7B” of FIG. 7A;

[0033] FIG. 8A is a side view of the nut of the connector assembly of FIG. 2;

[0034] FIG. 8B is a cross-sectional view taken along section line “8B-8B” of FIG. 8A;

[0035] FIGS. 9-12 are side views progressively illustrating operable coupling of the connector assembly of FIG. 2 with the screw assembly and rod of the system of FIG. 1 in accordance with the present disclosure;

[0036] FIGS. 13-18 progressively illustrate performing a revision surgery in accordance with the present disclosure;

[0037] FIGS. 19A and 19B are top perspective and bottom perspective views, respectively, of another connector provided in accordance with the present disclosure;

[0038] FIGS. 20A and 20B are top perspective and bottom perspective views, respectively, of another nut provided in accordance with the present disclosure; and

[0039] FIGS. 21-23 are perspective views of other set screws provided in accordance with the present disclosure.DETAILED DESCRIPTION

[0040] 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 vertebrae “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.

[0041] Turning to FIGS. 2-3B, a connector assembly 500 provided in accordance with the present disclosure is configured to operably couple to one of the screw assemblies of system 10 (see FIG. 1), e.g., one of the first screw assemblies 100, although it is contemplated that connector assembly 500 may be utilized with any suitable screw assembly, including polyaxialscrew assemblies, fixed angle screw assemblies, or any other screw assemblies. For the purposes herein, screw assembly 100 is generally described.

[0042] With additional reference to FIG. 9, screw assembly 100 includes a screw 110, a receiver 120, and a set screw 130. 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.

[0043] Receiver 120 of screw assembly 100 is configured to receive head 112 of screw 110 therein. Receiver 120 may be formed from a metallic material such as, for example, titanium or cobalt chrome. Other suitable metallic materials forming receiver 120 include, for example, stainless steel. In aspects, receiver 120 may further include polymeric material(s) to reduce wear on receiver 120 and / or components in contact therewith. Suitable polymeric materials include, for example, polyether ether ketone (PEEK), ultra-high-molecular-weight polyethylene (UHMWPE), polyethylene, carbon fiber reinforced PEEK, carbon composite, polylactic acid (PL A), and polyglycolic acid (PGA).

[0044] In aspects, head 112 of screw 110 is operably receivable within receiver 120 to permit angling of screw 110 relative to receiver 120 in at least one direction. In such aspects, head 112 of screw 110 may define a substantially spherical configuration to facilitate angling of screw 110 relative to receiver 120 in any suitable direction. In other aspects, head 112 of screw 110 is integrally formed with receiver 120 or otherwise fixed relative to receiver 120 such that screw 110 extends from receiver 120 at a fixed angle. In aspects, regardless of whether angulation of screw 110 relative to receiver 120 is permitted or inhibited, receiver 120 may be configured to rotate relative to screw 110, e.g., to re-orient a rod 400 received within receiver 120 relative to screw 110. Alternatively, receiver 120 may be rotationally fixed relative to screw 110.

[0045] Receiver 120 of screw assembly 100 is further configured to receive a rod, e.g., rod 400, therethrough, thereby operably coupling rod 400 to screw 110. More specifically, receiver120 may include a pair of saddles 124 that cooperate to form a rod-receiving channel 126 configured to receive rod 400 (or any other suitable rod).

[0046] Set screw 130 is configured to engage receiver 120 to maintain rod 400 and head 112 of screw 110 in operable engagement with receiver 120 and one another. In aspects, set screw 130 includes external threading 132 configured to engage corresponding internal threading (not shown) defined within receiver 120. In the engaged position, set screw 130 retains rod 400 within receiver 130 between head 112 of screw 110 and set screw 130, although other configurations are also contemplated. Set screw 130 may lock the angular position of screw 110 relative to receiver 120 when engaged with receiver 120 or may permit angulation of screw 110 relative to receiver 120 when engaged with receiver 120. Additionally or alternatively, set screw 130 may lock receiver 120 relative to rod 400 when engaged with receiver 120 or may permit sliding of rod 400 through receiver 120 when engaged with receiver 120. As detailed below, in order to operably couple connector assembly 500 to screw assembly 100, set screw 130 is disengaged and removed from receiver 120.

[0047] Referring to FIGS. 2-4, connector assembly 500 includes a connector 510, a set screw 540, and a nut 570. Connector 510 includes a head portion 512 configured to operably engage screw assembly 100 and rod 400, and a rod portion 514 extending from head portion 512. Set screw 540 is configured to replace the set screw 130 of screw assembly 100. More specifically, set screw 540 is configured to engage receiver 120 of screw assembly 100 similarly as detailed above with respect to set screw 130. Set screw 540 is further configured to receive head portion 512 of connector 510 to operably couple connector 510 to set screw 540 and, thus, to screw assembly 100 and rod 400. Nut 570 is configured to engage set screw 540 to thereby retain connector 510 about set screw 540 between nut 570 and receiver 120 of screw assembly 100. Connector 510, set screw 540, and nut 570 of connector assembly 500 are described in greater detail, in turn, below.

[0048] Turning to FIG. 5, connector 510 of connector assembly 500 includes, as noted above, a head portion 512 and a rod portion 514. Head portion 512 and rod portion 514 of connector 510 are integrally formed as a single component, e.g., via a single formation process (such as machining) or separate formation and subsequent joining of head portion 512 and rod portion 514. Connector 510 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 portion 514 of connector 510 defines a cylindrical configuration and, in aspects, connectors 510 having different diameter rod portions 514 may be provided to provide a suitable connector 510 for different purposes and / or for use with different patient anatomies. Likewise, connectors 510 of different materials may be provided to provide a suitable connector 510 for different purposes and / or for use with different patient anatomies. For example, a first connector 510 may be provided with a rod portion 514 having a diameter of 5.5mm and a second connector 510 may be provided with a rod portion 514 having a diameter of 6.0mm. Each of these first and second different diameter connectors 510, in turn, may be provided in a first version formed from titanium and a second version formed from cobalt chrome, thus providing four (4) different connectors 510. Other suitable additional or alternative diameters, materials, and / or combinations thereof are also contemplated. Rod portion 514 defines an initial length and is configured to be cut to a suitable length depending upon a particular purpose and / or patient anatomy. In aspects, the initial length of rod portion 514 is 200mm. In other aspects, connectors 510 of various different lengths are provided.

[0049] Rod portion 514 of connector 510 is bendable at any location or locations along the length of rod portion 514 (wherein the length of rod portion 514 is defined as the length of the cylindrical portion of connector 510) to enable formation of connector 510 in any suitable configuration for a particular purpose and / or patient anatomy. That is, head portion 512 is configured to taper down to the cylindrical rod portion 514 in close proximity to screw assembly 100 (FIGS. 2-3B) and rod 400 (FIGS. 2-3B) to thus enable bending of rod portion 514 at any location(s), including directly adjacent to head portion 512 without disrupting head portion 512, screw assembly 100 (FIGS. 2-3B) or rod 400 (FIGS. 2-3B).

[0050] More specifically, and with additional reference to FIGS. 6A-6C, the configuration of head portion 512 tapers to rod portion 514 (and enables bending of rod portion 514 at a location), in aspects, equal to or less than about 40mm from axis “X” of cylindrical transverse bore 532 of head portion 512 of connector 510; in other aspects, equal to or less than about 35mm from axis “X” of cylindrical transverse bore 532; in still other aspects, equal to or less than about 30mm from axis “X” of cylindrical transverse bore 532; or, in yet other aspects, equal to or less than about 25mm of axis “X” of cylindrical transverse bore 532. When connector 510 is installed about set screw 540 of connector assembly 500, a longitudinal axis of set screw 540 (FIGS. 2- 3B) is substantially coaxial with axis “X” of cylindrical transverse bore 532 and, thus, the abovedistances may likewise refer to distances from the longitudinal axis of set screw 540 (FIGS. 2- 3B) when connector assembly 500 is operably coupled to screw assembly 100 and rod 400 (see FIGS. 2-3B).

[0051] From another reference point, the configuration of head portion 512 tapers to rod portion 514 (and enables bending of rod portion 514 at a location), in aspects, equal to or less than about 30mm from a stop surface 535 of a cut out 534 of head portion 512 of connector 510; in other aspects, equal to or less than about 25mm from stop surface 535; in still other aspects, equal to or less than about 20mm from stop surface 535; or, in yet other aspects, equal to or less than about 15mm from stop surface 535. When connector 510 is operably coupled to screw assembly 100 and rod 400 (see FIGS. 2-3B), an end of rod 400 is configured for receipt within cut out 534 and, thus, the above distances may likewise refer to distances from the end of rod 400 (FIGS. 2-3B) when connector assembly 500 is operably coupled to screw assembly 100 and rod 400 (see FIGS. 2-3B).

[0052] Continuing with reference to FIGS. 5-6C, head portion 512 of connector 510 is detailed. Head portion 512 includes a base end 520, a neck end 522, a planar face surface 524, a concave curved face surface 526, a convex curved face surface 528, first and second side surfaces 530, a cylindrical transverse bore 532, and a cut out 534. Base end 520 of head portion 512 of connector 510 is at a free end of head portion 512 while neck end 522 is at the opposite end of connector 510 (along a length thereof) at the transition from head portion 512 to rod portion 514. As noted above, head portion 512 and rod portion 514 are integrally formed and, thus, do not necessarily define physical ends / beginnings at the transition therebetween; however, to provide suitable points of reference, rod portion 514 is defined herein the elongate cylindrical portion of connector 510 while head portion 512 is defined as the remaining portion of connector 510 (e.g., which does not define an elongate cylindrical configuration). That is, the location where connector 510 transitions from a non-cylindrical configuration to a cylindrical configuration defines the demarcation between head portion 512 and rod portion 514, regardless of the presence or absence of other physical demarcations.

[0053] Planar face surface 524 of head portion 512 extends from base end 520 to concave curved face surface 526, which extends from planar face surface 524 to neck end 522. Convex curved face surface 528 is disposed on an opposite face of head portion 512 compared to planar face surface 524 and concave curved face surface 526 and extends from base end 520 to neckend 522. Concave and convex curved face surfaces 526, 528 of head portion 512 define suitable radii of curvature such that concave curved face surface 526 and convex curved face surface 528 extend relative to one another to define a height at neck end 522 of head portion 512 equal to the diameter of rod portion 514 of connector 510. Concave and convex curved face surfaces 526, 528 are configured such that, as noted above, rod portion 514 may be bent at any location(s), including directly adjacent to head portion 512 without disrupting head portion 512, screw assembly 100 (FIGS. 2-3B) or rod 400 (FIGS. 2-3B).

[0054] First and second side surfaces 530 extend longitudinally between base end 520 and neck end 522 of head portion 512 on opposing sides of head portion 512. First and second side surfaces 530 each include a planar surface portion 531a disposed towards base end 520 of head portion 512 and extending transversely between planar face surface 524 and convex curved face surface 528 and a concave surface portion 531b disposed towards neck end 522 of head portion 512 and extending transversely between concave curved face surface 526 and convex curved face surface 528. Concave surface portions 531b of first and second side surfaces 530 taper inwardly towards one another in a direction from base end 520 towards neck end 522 to thereby taper a width of head portion 512 from a first width defined between planar surface portions 531a of first and second side surfaces 530 and a second width defined between concave surface portions 531b (at neck end 522) equal to the diameter of rod portion 514 of connector 510. Thus, with both concave and convex curved face surfaces 526, 528 and concave surface portions 531b of first and second side surfaces 530 tapering to the diameter of rod portion 514 at neck end 522, a smooth yet compact transition from head portion 512 to cylindrical rod portion 514 is achieved. Concave surface portions 531b are also configured such that, as noted above, rod portion 514 may be bent at any location(s), including directly adjacent to head portion 512 without disrupting head portion 512, screw assembly 100 (FIGS. 2-3B) or rod 400 (FIGS. 2-3B).

[0055] In aspects, the first width (e.g., a maximum width of head portion 514) is about 17.8mm. In aspects, a ratio of the first width to the diameter of rod portion 514 is from about 2.0 to about 4.0; in other aspects, from about 2.5 to about 3.5. A radius of curvature of concave curved face surface 526, in aspects, is different from a radius of curvature of convex curved face surface 528. More specifically, the radius of curvature of concave curved face surface 526 may be less than the radius of curvature of convex curved face surface 528 and, in aspects, a ratio of the radius of curvature of concave curved face surface 526 to the radius of curvature of convexcurved face surface 528 is from about 0.30 to about 0.54; in other aspects, from about 0.35 to about 0.49; or, in still other aspects, from about 0.40 to about 0.44. In aspects, the radius of curvature of concave curved face surface 526 is about 27.94mm and / or the radius of curvature of convex curved face surface 528 is about 66.40mm.

[0056] Referring still to FIGS. 5-6C, and with additional refence to FIGS. 2-3B, cylindrical transverse bore 532 defines an axis “X” and extends transversely through head portion 512 between planar face surface 524 and convex curved face surface 528. Cylindrical transverse bore 532 is configured to receive set screw 540 therethrough to enable positioning of connector 510 about set screw 540. Cylindrical transverse bore 532 may define a diameter that substantially approximates a diameter of set screw 540 to eliminate or reduce play therebetween when connector 510 is disposed about set screw 540, although other configurations are also contemplated. Axis “X” of cylindrical transverse bore 532 extends in substantially perpendicular orientation relative to a longitudinal axis of cylindrical rod portion 514 of connector 510.

[0057] Cut out 534, in aspects, defines a longitudinally extending, partially cylindrical configuration (wherein convex curved face surface 528 cuts off cut out 534 such that cut out 534 is not fully cylindrical). Cut out 534 is defined along an axis “Y” that is perpendicular to axis “X” and extends from convex curved face surface 528 of head portion 512 to an internal stop surface 535. Cut out 534 intersects cylindrical transverse bore 532 in perpendicular orientation relative to cylindrical transverse bore 532. Cut out 534 is configured to receive an end of rod 400 such that head portion 512 of connector 512 partially receives the end of rod 400 therein. As such, the cylindrical shape of cut out 534 may define a diameter that substantially approximates a diameter end of rod 400 to eliminate or reduce play therebetween when connector 510 is disposed about rod 400, although other configurations are also contemplated. The end of rod 400, when received within cut out 534, may extend into abutment with internal stop surface 535 of head portion 512 of connector 510 or may be spaced from internal stop surface 535, depending upon the length of the end of rod 400 extending from screw assembly 100. Further, as cut out 534 is open along convex curved face surface 528 of head portion 512, connector 510 may be disposed about rod 400 (such that cut out 534 receives rod 400 as detailed above) in a transverse direction, e.g., wherein connector 510 is moved in a substantially transverse direction relative to a longitudinal axis of rod 400.

[0058] Turning to FIGS. 7 A and 7B, set screw 540 defines a generally cylindrical configuration and includes a body 542 and a cap 544. Body 542 includes first threading 546 defined about an exterior annular surface of body 542 towards a first end of body 542. First threading 546 is configured to enable threaded engagement of set screw 540 within receiver 120 of screw assembly 100 (see FIG. 10).

[0059] Body 542 of set screw 540 further includes second threading 548 defined about an exterior annular surface of set screw 540 towards a second, opposite end of body 542. First and second threadings 546, 548 may be spaced apart from one another or may define minimal or no spacing therebetween along the length of body 542. Second threading 548 is configured to enable threaded engagement of nut 570 about set screw 540 (see FIG. 3A and 12). First and second threadings 546, 548 may define similar or different heights, spacings, pitches, and / or directions of pitch.

[0060] In aspects, body 542 defines a first cavity 550 extending longitudinally through at least a portion of a length thereof and having a suitable geometric, e.g., hexagonal, star-shaped, etc., cross-section configured to facilitate engagement with an assembly tool (not shown).

[0061] Cap 544 of set screw 540 is coupled to the second end of body 542 via a transition 552. In aspects, transition 552 defines a pre-determined break point wherein transition 552 breaks to thereby separate cap 544 from body 542. For example, as force (e.g., torque) applied to cap 544 reaches the pre-determined break point, transition 552 breaks, thereby separating cap 544 from body 542. In aspects, cap 544 defines a second cavity 554 extending longitudinally through at least a portion of a length thereof and 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. The rotational driver may provide the torque input to cap 544 to ultimately reach the pre-determined break point for separating cap 544 from body 542. More specifically, the rotational driver may be engaged (in fixed rotational orientation) within second cavity 554 to facilitate rotational driving of set screw 540 into engagement with receiver 120 (via threaded engagement of first threading 546 with corresponding threading (not shown) of receiver 120) up to the pre-determined break point, at which point set screw 540 is sufficiently engaged within receiver 120 and cap 544 is separated from body 542. With the removal of cap 544, first cavity 440 of body 542 is exposed, e.g., to enable receipt of an assembly tool (not shown), e.g., a rotational driver, for adjusting the position of set screw 540, removing set screw 540 fromreceiver 120, and / or other purposes. In aspects, cap 544 of set screw 540 is permanently formed with body 542, e.g., without a breakaway feature. Other set screws are also contemplated such as, for example, the set screws detailed below with reference to FIGS. 21-23.

[0062] Referring to FIGS. 8A and 8B, nut 570 defines internal threading 572 within an internal cavity 574 thereof to enable threaded engagement of nut 570 about set screw 540 and, more specifically, threaded engagement of internal threading 572 of nut 570 with second threading 548 of set screw 540. Nut 570, in aspects, includes a body 576, a cap 578, and a transition 580 (defining, in aspects, a pre-determined break point) interconnecting body 576 and cap 578 with one another. In such aspects, cavity 574 may be defined within body 576 and cap 578 may define another cavity 582 having a suitable geometric, e.g., hexagonal, star-shaped, etc., cross-section configured to facilitate engagement with an assembly tool (not shown).

[0063] Similarly as detailed above with respect to set screw 540, a rotational driver may engage cavity 580 to provide torque input to cap 578 to threadingly engage cap 578 about set screw 540 until the pre-determined break point of transition 580 is reached at which point nut 570 is sufficiently engaged about set screw 540 and cap 578 is separated from body 576. Nut 570 is configured to engage set screw 540 to retain head portion 512 of connector 510 between nut 570 and receiver 120 of screw assembly 100. Other nuts are also contemplated such as, for example, the nut detailed below with reference to FIGS. 20A and 20B.

[0064] Turning to FIGS. 9-18, the installation of connector assembly 500, e.g., during a revision surgery, is described. Although detailed with respect to coupling of connector assembly 500 with a previously implanted spinal system 10 including screw assembly 100 anchored in a vertebrae “V” and rod 400 interconnecting screw assembly 100 with one or more other components of system 10, it is understood that connector assembly 500 may similarly be installed and / or utilized with any other suitable spinal system.

[0065] Referring initially to FIGS. 9 and 13, screw assembly 100 and rod 400 are shown as previously installed, e.g., with set screw 130 of screw assembly 100 engaged with receiver 120 of screw assembly 100, thereby retaining rod 400 in operably engagement with screw assembly 100. In order to install connector assembly 500, rod 400 is cut (if needed), e.g., using a suitable cutting tool “T,” such that rod 400 extends from screw assembly 100 a distance that is equal to or less than a length of cut out 534 of head portion 512 of connector 510 (see FIG. 6C), thus enabling receipt of the end of rod 400 within cut out 534. Prior to or after cutting rod 400, setscrew 130 is removed from screw assembly 100. FIG. 14 illustrates system 10 with rod 400 cut and set screw 130 (FIG. 13) removed.

[0066] With reference to FIGS. 10 and 15, with set screw 130 (FIGS. 9 and 13) removed, set screw 540 of connector assembly 500 may be engaged with receiver 120, e.g., as detailed above. Referring to FIGS. 11 and 16, once set screw 540 is installed, connector 510 may be positioned about set screw 540, e.g., with set screw 540 received through cylindrical transverse bore 532 of head portion 512 of connector 510 and the end of rod 400 seated within cut out 534 of head portion 512 of connector 510. In this position, due to the above detailed configuration of connector 510, rod portion 514 of connector 510 is disposed in substantially coaxial relation relative to rod 400, thus functions as an extension of rod 400 with minimal disruption therebetween. More specifically, in aspects, rod portion 514 of connector 510 is disposed in coaxial relation relative to rod 400. In other aspects, rod portion 514 of connector 510 is disposed in parallel orientation relative to rod 400 wherein the longitudinal axes of rod portion 514 of connector 510 and rod 400 are horizontally aligned but vertically offset a minimal distance (see FIGS. 11 and 12), e.g., equal to or less than about 1.5mm, in aspects.

[0067] As detailed above, rod portion 514 of connector 510 may be bent (prior to or after the above-detailed installation) to achieve a desired configuration. As also detailed above, the configuration of head portion 512 of connector 510 enables rod portion 514 to be bent in close proximity to screw assembly 100 and the end of rod 400 such that a desired configuration of the collective rod formed by rod 400 and rod portion 514 of connector 510 may be achieved similarly as if there were no interruption in the rod.

[0068] Turning to FIGS. 12 and 17, with connector 510 disposed about set screw 540 and the end of rod 400 as detailed above, nut 570 may be engaged about set screw 540 to thereby retain the operable coupling of connector 510 with screw assembly 100. Referring to FIG. 18, one or more additional components, e.g., screw assemblies 100, may be coupled with rod portion 514 of connector 510 similarly as would be accomplished with any other rod segment of system 10.

[0069] With reference to FIGS. 19A and 19B, another connector provided in accordance with the present disclosure is shown generally identified by reference numeral 1510. Connector 1510 is similar to and may include any of the features of connector 510 (FIGS. 5-6C), except as explicitly contradicted hereinbelow. Accordingly, only differences between connector 1510 andconnector 510 (FIGS. 5-6C) are described in detail below while similarities are summarily described or omitted entirely.

[0070] Connector 1510 includes a head portion 1512 and a rod portion 1514 integrally formed as a single component. Head portion 1512 includes opposing first and second face surfaces 1524, 1526, a pair of transverse slots 1532, and a cut out 1534. First and second face surfaces 1524, 1526 may be planar surfaces or, similarly as with connector 510 (FIGS. 5-6C), first face surface 1524 may be planar and second face surface 1526 may be convex (or may include a planar portion and a convex portion). Cut out 1534 is defined within second face surface 1526. Transverse slots 1532 extend transversely through head portion 1512 between first and second face surfaces 1524, 1526 and are disposed on opposite sides of cut out 1534. Thus, rather than a transverse aperture intersecting the cut out, connector 1510 includes transverse slots 1532 on either side of cut out 1534. Transverse slots 1532 are configured to receive the upright portions of saddles 124 of receiver 120 of screw assembly 100 (see FIGS. 2-3B) to engage connector 1510 on receiver 120 (FIGS. 2-3B). A set screw may engage receiver 120 on top of connector 1510 (e.g., within a recess defined within first face surface 1524 between transverse slots 1532) to thereby retain connector 1510 in engagement on receiver 120 (FIGS. 2-3B).

[0071] Referring to FIGS. 20 A and 20B, another nut provided in accordance with the present disclosure is shown generally identified by reference numeral 2570. Nut 2570 is similar to and may include any of the features of nut 570 (FIGS. 8A and 8B), except as explicitly contradicted hereinbelow. Accordingly, only differences between nut 2570 and nut 570 (FIGS. 8 A and 8B) are described in detail below while similarities are summarily described or omitted entirely.

[0072] Nut 2570 includes a body 2576 configured to receive an engagement tool, e.g., a wrench, thereabout to enable threaded engagement of nut 2570 about a set screw. Unlike nut 570 (FIGS. 8A and 8B), nut 2570 does not include a breakaway cap, although it is contemplated that, in aspects, nut 2570 may include a breakaway cap. Further, nut 2570 includes a planar base surface 2579 configured to engage planar face surface 524 of connector 520 (FIGS. 5-6C) although it is contemplated, in aspects, that nut 2570 may include a serrated base surface as with nut 570 (FIGS. 8A and 8B).

[0073] Turning to FIGS. 21-23, other set screws provided in accordance with the present disclosure are shown generally identified by reference numerals 3540, 4540, and 5540, respectively. Set screws 3540, 4540, 5540 are similar to and may include any of the features ofset screw 540 (FIGS. 7A and 7B), except as explicitly contradicted hereinbelow. Accordingly, only differences between set screws 3540, 4540, 5540 and set screw 540 (FIGS. 7A and 7B) are described in detail below while similarities are summarily described or omitted entirely.

[0074] Referring to FIG. 21, set screw 3540 includes a body 3542 having first and second threading portions 3546, 3548 spaced apart from one another, although it is also contemplated that first and second threading portions 3546, 3548 may define minimal or no spacing therebetween. First and second threading portions 3546, 3548 may be substantially cylindrical and may define similar or different diameters. More specifically, as shown, first threading portion 3546 may define a first diameter and second threading portion 3548 may define a second, smaller diameter. Additionally or alternatively, first and second threading portions 3546, 3548 may define different or similar heights, spacings, pitches, and / or directions of pitch. Set screw 3540 does not include a breakaway cap, although it is contemplated that, in aspects, a breakaway cap may be provided.

[0075] With reference to FIG. 22, set screw 4540 includes a body 4542 and a breakaway cap 4544, although it is also contemplated that cap 4544 be permanently secured to body 4542 or omitted entirely. Body 4542 defines a substantially cylindrical configuration of substantially constant diameter and includes first and second threadings 4546, 4548. First and second threadings 4546, 4548 may define different or similar heights, spacings, pitches, and / or directions of pitch.

[0076] FIG. 23 illustrates set screw 5540 including a includes a body 5542 and a breakaway cap 5544, although it is also contemplated that cap 5544 be permanently secured to body 5542 or omitted entirely. Body 5542 defines a substantially cylindrical configuration of substantially constant diameter and includes a continuous threading 5546 along the length thereof. Continuous threading 5546 may define a constant spacing and / or pitch or may define portions of different spacing and / or pitch. Continuous threading 5546 includes different portions that provide the functions of the first and second threadings of the other set screws detailed herein.

[0077] 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 aslimiting, 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.

[0078] Example 1. A connector configured for use with a spinal surgical system, the connector comprising:

[0079] a rod portion defining a longitudinal axis; and

[0080] a head portion integrally connected to the rod portion, the head portion having a transverse bore defined therethrough and a longitudinal cut out defined therein, the transverse bore defining a first axis substantially perpendicular to the longitudinal axis of the rod portion and configured to enable coupling of the head portion to a screw assembly, the longitudinal cut out defining a second axis substantially parallel to or substantially coaxial with the longitudinal axis of the rod portion and configured to receive a portion of a rod therein such that the portion of the rod is substantially parallel to or substantially coaxial with the rod portion.

[0081] Example 2. The connector according to example 1, wherein the head portion defines a first face and a second face, the first face including a planar surface extending to a concave surface, the concave surface extending from the planar surface to the rod portion.

[0082] Example 3. The connector according to example 2, wherein the second face includes a convex surface.

[0083]

[0084] Example 4. The connector according to example 3, wherein the concave surface defines a radius of curvature less than a radius of curvature of the convex surface.

[0085]

[0086] Example 5. The connector according to example 3, wherein the transverse bore extends from the planar surface on the first face to the convex surface on the second face.

[0087]

[0088] Example 6. The connector according to example 1, wherein the longitudinal cut out is open along a convex surface of the head portion to enable positioning of the portion of the rod within the longitudinal cut out in a direction perpendicular to a longitudinal axis of the portion of the rod.

[0089] Example 7. The connector according to example 1, wherein the head portion includes first and second opposing faces interconnected by first and second opposing sides, the first and second opposing sides tapering inwardly towards one another in a direction from the head portion towards the rod portion.

[0090] Example 8. A connector assembly configured for use with a spinal surgical system, the connector assembly comprising: a set screw configured to engage a receiver of a screw assembly; a connector, including: a rod portion defining a longitudinal axis; and a head portion integrally connected to the rod portion, the head portion having a transverse bore configured to receive the set screw to position the head portion of the connector about the set screw, the head portion further having a longitudinal cut out defined therein, the longitudinal cut out configured to receive a portion of a rod therein and defining an axis substantially parallel to or substantially coaxial with the longitudinal axis of the rod portion such that the portion of the rod received within the longitudinal cut out is substantially parallel to or substantially coaxial with the rod portion; and a nut configured to engage the set screw to thereby retain the head portion of the connector between the nut and the screw assembly.

[0091] Example 9. The connector assembly according to example 8, wherein the set screw includes first threading configured to engage corresponding threading of the receiver of the screw assembly and second threading configured to engage corresponding threading of the nut.

[0092] Example 10. The connector assembly according to example 8, wherein the head portion of the connector defines a first face and a second face, the first face including a planar surface extending to a concave surface, the concave surface extending from the planar surface to the rod portion, the second face including a convex surface.

[0093] Example 11. The connector assembly according to example 10, wherein the concave surface defines a radius of curvature less than a radius of curvature of the convex surface.

[0094] Examples 12. The connector assembly according to example 10, wherein the planar surface is configured to face the nut and wherein the convex surface is configured to face the screw assembly.

[0095] Example 13. The connector assembly according to example 8, wherein the longitudinal cut out is open along a convex surface of the head portion to enable positioning of the portion of the rod within the longitudinal cut out in a direction perpendicular to a longitudinal axis of the portion of the rod.

[0096] Example 14. A spinal surgical system, comprising: a rod; a screw assembly including a screw and a receiver coupled to the screw, the screw configured for engagement within spinal bone of a patient and the receiver configured to receive the rod; and a connector assembly configured to engage the screw assembly, the connector assembly including: a set screw configured to engage the receiver of the screw assembly to retain the rod within the receiver; a connector including a rod portion defining a longitudinal axis and a head portion integrally connected to the rod portion, the head portion having a transverse bore configured to receive the set screw to couple the connector to the screw assembly, the head portion further having a longitudinal cut out defined therein and configured to receive a portion of the rod therein such that the rod and the rod portion are substantially parallel to or substantially coaxial with one another; and a nut configured to engage the set screw to thereby retain the connector coupled to the screw assembly.

[0097] Example 15. The spinal surgical system according to example 14, wherein a head of the screw is operably received within the receiver to enable angulation of the receiver relative to the screw.

[0098] Example 16. The spinal surgical system according to example 14, wherein the receiver is configured to receive a head of the screw on one side of the rod and the set screw on a second, opposite side of the rod.

[0099] Example 17. The spinal surgical system according to example 14, wherein the set screw includes first threading configured to engage corresponding threading of the receiver of the screw assembly and second threading configured to engage corresponding threading of the nut.

[0100] Example 18. The spinal surgical system according to example 14, wherein the head portion of the connector defines a first face and a second face, the first face including a planar surface extending to a concave surface, the concave surface extending from the planar surface to the rod portion, the second face including a convex surface.

[0101] Example 19. The spinal surgical system according to example 18, wherein the concave surface defines a radius of curvature less than a radius of curvature of the convex surface.

[0102] Example 20. The spinal surgical system according to example 14, wherein the longitudinal cut out is open along a convex surface of the head portion to enable positioning of the portion of the rod within the longitudinal cut out in a direction perpendicular to a longitudinal axis of the portion of the rod.

Claims

WHAT IS CLAIMED IS:

1. A connector (510) configured for use with a spinal surgical system (10), the connector (510) comprising: a rod portion (514) defining a longitudinal axis; and a head portion (512) integrally connected to the rod portion (514), the head portion (512) having a transverse bore (532) defined therethrough and a longitudinal cut out (534) defined therein, the transverse bore (532) defining a first axis (“X”) substantially perpendicular to the longitudinal axis of the rod portion (514) and configured to enable coupling of the head portion (512) to a screw assembly (100), the longitudinal cut out (534) defining a second axis (“Y”) substantially parallel to or substantially coaxial with the longitudinal axis of the rod portion (514) and configured to receive a portion of a rod (400) therein such that the portion of the rod (400) is substantially parallel to or substantially coaxial with the rod portion (514).

2. The connector (510) according to claim 1, wherein the head portion (512) defines a first face and a second face, the first face including a planar surface (524) extending to a concave surface (526), the concave surface (526) extending from the planar surface (524) to the rod portion (514).

3. The connector (510) according to claim 2, wherein the second face includes a convex surface (528).

4. The connector (510) according to claim 3, wherein the concave surface (526) defines a radius of curvature less than a radius of curvature of the convex surface (528).

5. The connector (510) according to claim 3, wherein the transverse bore (532) extends from the planar surface (524) on the first face to the convex surface (528) on the second face.

6. The connector (510) according to claim 1, wherein longitudinal cut out (534) is open along a convex surface (528) of the head portion (512) to enable positioning of the portion of the rod (400) within the longitudinal cut out (534) in a direction perpendicular to a longitudinal axis of the portion of the rod (400).

7. The connector (510) according to claim 1, wherein the head portion (512) includes first and second opposing faces interconnected by first and second opposing sides (530), the first and second opposing sides (530) tapering inwardly towards one another in a direction from the head portion (512) towards the rod portion (514).

8. A connector assembly (500) configured for use with a spinal surgical system (10), the connector assembly (500) comprising: a set screw (540) configured to engage a receiver (120) of a screw assembly (100); the connector (510) according to any one of claims 1-7; and a nut (570) configured to engage the set screw (540) to thereby retain the head portion (512) of the connector (510) between the nut (570) and the screw assembly (100).

9. The connector assembly (500) according to claim 8, wherein the set screw (540) includes first threading (546) configured to engage corresponding threading of the receiver (120) of the screw assembly (100) and second threading (548) configured to engage corresponding threading (572) of the nut (570).

10. A spinal surgical system (10), comprising: a screw assembly (100) including a screw (110) and a retainer (120) coupled to the screw (110), the screw (110) configured for engagement within spinal bone of a patient and the retainer (120) configured to receive a rod (400); and the connector assembly (500) according to claim 8 or 9.

11. The spinal surgical system (10) according to claim 10, wherein a head (112) of the screw (110) is operably received within the receiver (120) to enable angulation of a shank (114) of the screw (110) relative to the retainer (120).

12. The spinal surgical system (10) according to claim 10 or 11, wherein the receiver (120) is configured to receive a head (112) of the screw (110) on one side of the rod (400) and the set screw (540) on a second, opposite side of the rod (400).

Citation Information

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