The present disclosure is directed to the field of spinal fixation, and specifically, to a low profile coupler for securing adjacent rods together in a fixed relation during spinal correction procedures.
Spinal rod systems for use in facilitating spinal fusion, and for correcting and stabilizing spinal curvatures to correct spinal disorders or degenerative conditions, are well known in the art. Spinal rod systems include two or more bone fixation members coupled together with spinal rods. The conventional bone fixation member has a proximal end constructed and arranged to secure to a vertebrae, and a distal end connected to a spinal rod. During a spinal correction procedure, a plurality of fixation members are fixed to vertebrae at various points on each side of the spinal midline. Thereafter, each of the fixation members on each side of the spinal midline is linked with the other fixation members by an elongated spinal rod, such that the spinal rod extends vertically along at least a portion of the length of the spine.
Connector systems for transversely and rigidly connecting adjacent spinal rods together are also well known. Such connector systems are beneficial because they restrict spinal rod migration and increase the overall stiffness of the spinal rod system. In procedures involving multi-level fusion of the spine, a transverse connector system may be essential during the post operative period to minimize the amount of motion permitted between the spinal rods. By providing a rigid transverse connection between adjacent spinal rods, a stiffer construct can be created to enhance the promotion of spinal fusion.
Spinal rods are mounted by a surgeon in a custom-fit manner, both in length and angular positioning. Bending of the rod is common so that the rod is holding the vertebral portions in proper relation. There is not a predetermined distance between two spinal rods, and the rods may converge or diverge from each other. One spinal rod may have a portion directed at an angle different from that of a second other rod.
It is common for the connecting members to have a hook portion extending around a spinal rod and pointing back towards the center of the connecting member. In such an arrangement, installation or implantation of the device requires lateral clearance of the spinal rods so that the hook portion can be placed outside of the spinal rod and then drawn inward for securement on the rod. Often, the patient's soft tissue must be cleared for this purpose; a result which may exacerbate pain, discomfort, and healing time. Many connecting members utilize set screws. For instance, set screws may be utilized for securing a hook type connector, or a U-shaped connector to the spinal rod. The set screw may be utilized for securing one connector end relative to the other.
U.S. Pat. No. 5,947,966 discloses a transverse connector system for linking adjacent spinal rods together. The system includes first and second connector portions which are slidably adjustable in relation to each other. Each connector portion includes an engaging member configured to receive a spinal rod. A wedge member is provided in each engaging member to secure each connector portion to the spinal rod. The wedge member includes a screw for engaging and biasing the spinal rod into a receptacle defined by the engaging member.
U.S. Pat. No. 5,683,392 discloses a multi planar locking mechanism for securing a spinal rod to the spinal column. The locking mechanism includes a bone fixation member for attachment to the bone member, the bone fixation member having a spherical portion; an inner housing member having a channel for receiving the rod and having a spherical portion for engaging the spherical portion of the bone fixation member; and an outer housing member for locking the inner housing member to the rod and the spherical portion of the bone fixation member.
U.S. Pat. No. 6,413,258 discloses a rod-to-rod coupler which includes a body having first and second coupler portions. Each coupler portion defines a concavity configured to receive a portion of an elongated spinal rod. A screw and nut assembly, which includes a screw and a flanged nut, is positioned adjacent each concavity. Each flanged nut has a flange portion which extends at least partially over one concavity.
U.S. Pat. No. 6,113,600 discloses a spinal fixation system having a pair of longitudinal members positionable adjacent the spine, an engaging member for engaging longitudinal members to the spine, a pair of wedge members each having a bearing surface configured to bear on a longitudinal member, and a connector configured to span a distance between the longitudinal members. The connector includes a pair of engaging members each having a fixation surface and a connecting surface, and a bridge member attached to the connecting surfaces.
U.S. Pat. No. 6,238,396 discloses a surgical cross-connecting apparatus for spinal column surgery procedures having rotatable hooking elements with a hook and adjustable securing device, each hooking element is inserted in apertures in one of two elements.
U.S. Pat. No. 7,744,633 discloses a crosslink member for securing spinal rods having connector ends that include a brace and a locking member, each connector includes an arcuate face resting on and securing a spinal rod. The locking member is a cam member that rotates relative to the locking member and engages the connector to displace the cam member. The crosslink includes a male connector with a cylindrical cross rod received by a cavity in a female connector. The cross rod is secured by a pivotable clamp device in the female connector, and the cross rod connector and female connector may pivot, rotate, and telescope relative to each other.
U.S. Pat. No. 10,136,925 discloses a spinal cross-connector having an elongated member, a first connector, and a second connector. The first connector and the second connector are configured to receive spinal rods and adaptable to directly attach with pedicle screws. The first connector includes a first collet head, a first clamp and a first locking means. The second connector includes a second collet head, a second clamp and a second locking means. The first locking means is configured to tighten over a first collet head and engage with the first connector. Similarly, the second locking means is configured to tighten over a second collet head and engage with the second connector. The engagement of the first locking means with the first connector and the second locking means with the second connector locks the spinal cross-connector.
U.S. Pat. RE42,867 discloses an orthopedic device used to fix and stabilize bones to correct anomalies in skeletal structure occurring naturally or by trauma. Bone screws are screwed into bones by application of torque. Clamps are movably attached to the screws. Each clamp includes a compression ring. A connecting rod connects several screws through slots in the clamps. The clamps are tightened to hold the rod and the heads in a pre-selected position by linear movement of the compression rings.
Accordingly, a need exists for an improved spinal rod-to-rod connector system which can be easily and quickly secured between adjacent spinal rods to provide a rigid stabilizing system.
Disclosed is an ultra-low profile rod-to-rod coupler for connecting adjacent spinal rods. The rod-to-rod coupler consists of an outer bar member having a first end forming a receptacle and a second end available for coupling to a first spinal rod. An inner bar member having a unidirectional insertion end is slidably insertable into the receptacle of the outer bar member, wherein a second end remains available for coupling to a second spinal rod. The insertion end includes a centrally disposed slot bifurcating said insertion end into a left arm and a right arm. A locking member positioned in the centrally disposed slot allows for fixation of the inner bar member to the outer bar member. Placement of the locking member in a first position permits movement of the insertion end within the receptacle. Placement of the locking member in a second position results in splaying the left arm and right arm to frictionally engage an inner sidewall of the receptacle, thereby locking the inner bar member to the outer bar member.
An objective of the invention is to provide an ultra-low profile spinal rod-to-rod coupler for stabilizing adjacent spinal rods.
Another objective of the invention is to provide an adjustable rod-to-rod coupler.
Still another objective of the invention is to provide a rod-to-rod coupler having a unidirectional inner bar member that is insertable in an outer bar member, the inner bar member having a ramp surface constructed and arranged to engage a tab on the outer bar member. The ramp and tab prevent removal of the inner bar member from the outer bar member once inserted.
Yet still another objective of the invention is to provide a rod-to-rod coupler having a slidable locking member to frictionally engage and arrest movement of an inner bar member in relation to an outer bar member, the locking member moved in a slot by use of a pliers.
Yet still another objective of the invention is to provide a rod-to-rod coupler having a rotatable locking member to frictionally engage and arrest movement of an inner bar member in relation to an outer bar member, the locking member rotated in a slot by use of a torque driver.
Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification, include exemplary embodiments of the present invention, and illustrate various objects and features thereof.
While the present invention is susceptible of embodiments in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification of the invention and is not intended to limit the invention to the specific embodiments illustrated.
Referring to the Figures, illustrated is an embodiment of an ultra low profile rod-to-rod coupler 10 for connecting to spinal rods, not shown. The rod-to-rod coupler 10 comprises an outer bar member 12 having a first end 14 forming a receptacle 16 formed from a bottom surface 18, an outer surface 19, first and second side surfaces 20, 22 and upper surfaces 24, 26. A second end 30 is available for coupling to a rod coupler 32, which in turn is secured to a first spinal rod, not shown. The second end 30 depicted is a spherical head. In this embodiment, the second end 30 is illustrated attached to a rod coupler 32 having a U-shaped socket 34 for receipt of a first connector rod, not shown, and a set screw aperture 36 for receipt of a conventional set screw, not shown, used for locking the second end 30 to the first connector rod. The U-shaped rod coupler 32 illustrated may be substituted for a hook-shaped rod coupler or the like.
An inner bar member 40 having a unidirectional insertion end 42 configured and dimensioned to be slidably insertable into the receptacle 16. The insertion end 42 has a top side 44, a bottom side 45, and opposite sides 46, 48. A centrally disposed slot 50 extends between the top side 44 and the bottom side 45; the slot 50 bifurcating the insertion end 42 into a left arm 52 and a right arm 54, wherein each arm 52, 54 has an adjoined proximal end 56 beginning with an edge of the slot 50 and extending to spaced apart tips 57, 58 having an inner surface 62, 64 with each tip having a curved leading edge 66, 68. The space between the tips 57, 58 is identified by numeral 61.
The curved leading edges 66, 68 allow for ease of insertion into the receptacle 16. The opposite end 60 of the inner bar member 40 is spherical shaped and available for coupling to a second rod coupler 32′. The opposite end 60 illustrated is securable to a rod coupler 32′ for example purposes. The rod coupler 32′ has a socket 34′ for receipt of a second connector rod (not shown), and a set screw aperture 36′ for receipt of a conventional set screw for use in securing the opposite end 60 to a second connector rod.
A locking member 70 is positioned in the centrally disposed slot 50. The locking member 70 is movable between a first position 72 depicted in
For installation, a first opening 80 and a second opening 82 allow receipt of needle nose pliers, not shown. The tips of the pliers are placed within the openings 80, 82, which reduces the pressure required to move the locking member 70 from the unlocked position 72 to the locked position 74. The pliers engage the wedge shaped surface 84, 86, locking the first and second arms 52, 54 against the side surfaces 20, 22 of the receptacle 16 to allow movement without disturbing the position of the inner bar member 40 in relation to the outer member 12. A third opening 88 permits receipt of the pliers tips for moving the locking member 70 from the locked position 74 to an unlocked position 72.
There is an open area 61 when assembling the inner bar member 40 into the outer bar member 12. The opening 61 formed at the front of the inner bar member 40 allows the first and second arms 52, 54 to collapse as it is inserted into the outer bar member 12. The wider portion of the inner bar member 40 contacts the narrower portion of the outer bar member 12, causing a reduction in spacing of the opening 61. After inserting past that area, the inner bar member 40 then springs back to its original shape for the operating range of the device. By returning to the original shape the opening area 61 does not allow the inner bar member 40 and the outer bar member 12 to disengage from each other when used in combination with a lip 90 and ramp 94 described hereafter.
Referring to
To provide an ultra low profile, a sidewall groove 100 is formed along an upper outer edge of the inner bar member 40. The groove 100 allows a portion of the inner bar member 40 to engage the upper walls 24, 26 of the outer bar member 12, wherein an upper surface 44 of the inner bar member 40 is flush with upper surface 102, 104 of the outer bar member 12. In addition, locking member 70 employs a lower ridge 110 that engages a reciprocal ridge 112 formed on the bottom wall 45 of the inner bar member 40. The lower ridge 110 prevents the locking member 70 from passing through the slot 50. Once the inner bar member 40 is inserted into the outer bar member 12, the bottom 114 of the locking member 70 rests on the bottom surface 18 of the receptacle 16.
The outer bar member 12, the inner bar member 40, and the locking member 70, 120 is formed of titanium or stainless steel.
The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more” or “at least one.” The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.”
The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a device that “comprises,” “has,” “includes” or “contains” one or more steps or elements, possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes” or “contains” one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.
All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein.
One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures, and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary, and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.
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