Patent Description:
Surgery, whether of the spine or other areas of the body, is often complex and routinely involves the need for highly experienced medical staff, in addition to well-designed and well-manufactured implants, made to exacting specifications. Often the implants take the form of various types of hardware. In the area of spinal fixation, for example, various spinal fixation devices have been developed in the art. Some examples of such fixation devices include spinal rods, plates, corpectomy cages, and intervertebral discs, to name but a few. Spinal fixation rods are fixation devices configured to fix adjacent vertebrae of a spine relative to each other. The rods provide stabilization of the spine till fusion occurs. The spinal fixation rods are often used in spinal surgeries to repair spinal abnormalities, whether related to injury or otherwise. The spinal rods are configured to attach to the vertebrae using, for example, anchoring devices like pedicle screws and hooks.

Patients often experience extreme and debilitating pain because of spinal column injuries or from spinal column disorders such as spondylolisthesis and scoliosis. Pain may be attributed to issues of the spine as related to degeneration, deformity, and/or injury. Often a typical course of treatment involves surgical spinal fixation utilizing spinal fixation rods that mechanically immobilize areas of the spine causing, ideally, the eventual fusion of the treated vertebrae.

Sometimes additional surgical procedures, known as revision surgeries, become necessary. Several causes exist for the need for revision surgeries. For example, pseudarthrosis (failure to achieve solid fusion) may have occurred, which can be due to various causes such as poor tissue healing, improper implant placement or securement, implant failure, or to patient-related factors. Sometimes revision surgeries are indicated even after successful initial surgeries, given that the function and shape of the spine can deteriorate with age. Also, after prolonged use, the spinal fixation rods may move or become dislodged or unstable, or even bend or break.

Revision surgery is also required to treat adjacent segment disease ("ASD"). Spinal fusion recipients may be at risk for developing ASD, a condition in which the motion segments adjacent to the fused vertebral segments experience higher rates of degeneration or deterioration due to an increase in vertebral loading, higher intradiscal pressures, increased range of motion, and increased facet motion. Treatment options for ASD begin with determining whether the primary fusion is intact. If so, then a revision surgery with a revision connector is a likely course of action.

What is needed is a universal revision connector that is easy to install, with minimal profile, and/or at desired angles with the primary fusion rod. The connector ideally minimizes the disruption of the previous fusion mass and imposes less violation of the scar tissue. The stabilization may be extended to the next level above or below the fusion. Additional benefit is also achieved with a connector that can be inserted percutaneously. Ideally, a connector is desired that is not only suitable for revision surgeries, but also for primary fusion surgeries. The present connector provides vast improvement over such existing revision connectors.

<CIT> discloses correcting and stabilizing spinal column deformities to help minimize attachment anchor sites, facilitate use of straight or contoured rods, and/or help promote physiologic motion of the spinal column during and/or after correction.

<CIT> discloses a fixing rod connecting device and, more specifically, to a fixing rod connecting device, comprising: a main body having a space into which one or more rods can be inserted; and a fixing screw fastened to the main body so as to fix the rod, wherein one side surface of the main body is formed to have a predetermined upward inclination angle relative to the other side surface thereof, thereby eliminating interference with other surgical instruments when the fixing screw is fastened, enabling an incision area of a patient to be minimized, and enabling three-dimensional alignment and fixation of the rod.

In some embodiments of the invention, an implantable connector system may comprise a connector having a first receptacle, a second receptacle, and a first bushing received in the first receptacle. In various embodiments, the connector may include a first threaded opening intersecting the first receptacle and a second threaded opening intersecting the second receptacle. In some embodiments, the system may include a first rod matingly received within the first bushing. In addition, in various embodiments, the system may include a second rod matingly received within the second receptacle. In some embodiments, the system may include a first fastener configured to threadably engage the first threaded opening. Moreover, in various embodiments, the system may include a second fastener configured to threadably engage the second threaded opening.

In some embodiments, the connector may further include a second bushing received within the second receptacle, and the second rod may be matingly received within the second bushing. In various embodiments, the second receptacle may include a slot extending through an outer periphery of the connector to receive the second rod. Moreover, in some embodiments, the first fastener and the second fastener may be a set screw. In various embodiments, the first receptacle of the connector may include a through hole and the first bushing may include an indentation, wherein the through hole of the first receptacle and the indentation of the first bushing may receive a portion of a pin. In some embodiments, the first bushing may be spherical and may include a slot. In various embodiments, the system may further include one or more pedicle screws.

In various embodiments, a connector for an implantable connector system may comprise a fixed body defining a first receptacle and a second receptacle. In some embodiments the first receptacle, the second receptacle, or both may have a bushing therein. In various embodiments, the connector may include a first threaded opening intersecting the first receptacle. Moreover, in some embodiments, the connector may include a second threaded opening intersecting the second receptacle. In various embodiments, the connector may include at least one first fastener threadingly engaging the first threaded opening and extending into said first receptacle of the body. In addition, in some embodiments, the connector may include at least one second fastener threadingly engaging the second threaded opening and extending into the second receptacle of the body.

In addition, in various embodiments, each one of the first receptacle and the second receptacle may include the bushing. In some embodiments, the second receptacle may include a slot extending through an outer periphery of the connector to receive a second rod. In various embodiments, the slot may pass through the second threaded opening. In some embodiments, the first receptacle of the connector may include a through hole and the bushing, wherein the bushing may include an indentation, and wherein the through hole of the first receptacle and the indentation of the bushing may receive a portion of a pin. Moreover, in various embodiments, the first receptacle may include a front opening connected to a back opening of an outer periphery of the fixed body. In some embodiments, the front opening may be a slot that the bushing passes through when being inserted into the first receptacle. In various embodiments, the bushing may allow displacement of a rod up to about <NUM> degrees about an axis of the first receptacle and/or the second receptacle, respectively.

Described but not claimed is a method of implanting an implantable connector system comprising the steps of providing a connector having a first receptacle, a second receptacle, and a first bushing positioned in the first receptacle. The method may include inserting a first rod into the first bushing in the first receptacle. The method may include inserting a second rod into the second receptacle. In addition, the method may include threading a first fastener into engagement with the first bushing. The method may include threading a second fastener into engagement with the second receptacle.

In addition, , the connector may include a second bushing in the second receptacle, and inserting the second rod into the second bushing in the second receptacle. The method may include inserting the first bushing into the first receptacle and may include the first bushing being axially inserted into the first receptacle in a first orientation and pivoted to a second orientation different from the first orientation. The method may include at least one of loading the second rod into the second receptacle by at least axially-loading, top-loading, or side-loading. Moreover, the method may include displacing the first rod and the first bushing up to about <NUM> degrees from an axis of the first receptacle.

The disclosure herein is directed to an apparatus, system, and method (not claimed) for use in primary or revision surgeries. The system or implantable connector system would typically include at least a connector, one or more fasteners, a rod, and one or more bushings in some embodiments.

<FIG> shows a first embodiment of the implantable connector system <NUM> and/or connector <NUM>. In the embodiments described herein, the context of a revision surgery will be used as an example, it being understood that the principles, methods, and structures involved are equally suited in the context of primary surgery as well. For example, in the context of a revision surgery, the embodiments describe the rod that is connected to the "primary fusion rod" to be a "revision rod". However, in primary fusion surgeries using the apparatus herein, the "revision rod" is more generically referred to as a secondary fusion rod.

In a first embodiment as shown in <FIG>, the apparatus includes a side-loading, connector <NUM> for coupling a revision rod <NUM>, or secondary rod, to a primary (pre-existing, if in a revision surgery) fusion rod <NUM> of a pedicle screw system <NUM>. The connector <NUM> is a laterally loaded configuration that fits over or cradles an existing rod <NUM> and spaces the rod <NUM> therefrom. One or more connectors <NUM> may be used to combine one or more rods, one or more pedicle screws, and/or other structure to the one or more pedicle screw systems or one or more rods. The connectors <NUM> may be coupled to one or more rods <NUM> that may be straight and/or curved (e.g. when rods are contoured to match the sagittal profile of the spine). The connectors <NUM> add on or extend existing fusion constructs or may increase the rigidity and corrective power and stability of a construct. Although the connector <NUM> may be laterally loaded as shown in the one embodiment (e.g. <FIG>), the one or more connectors <NUM>, <NUM> may be axially-loaded and/or top-loaded, respectively, with the rod <NUM> as well in some embodiments. Although the embodiment of the implantable connector system <NUM>, as shown in <FIG>, includes one or more pedicle screws <NUM> attached thereto, it should be understood that the system <NUM> may not include pedicle screws in some embodiments or applications.

As shown in the embodiment of <FIG>, the connector <NUM> may include two or more receptacles 31a, 31b to couple or matingly receive the corresponding rods. This configuration may allow for connection to an existing construct wherein the connector may be placed between fixation points to the spine, pedicle screws or hooks, without having to remove the rod from these fixation points in order to place the connector. The connector <NUM> may include one or more bushings <NUM> positioned within the one or more receptacles. At least one of the receptacles or first receptacle 31a may include or receive the bushing <NUM>. The bushing <NUM> may matingly receive the rod <NUM> (e.g. revision and/or primary rod). Spaced from and/or separate from the first receptacle 31a, is another or second receptacle(s) 31b. Although, the receptacles (e.g. first and second receptacles 31a, 31b) may be different from each other as shown in <FIG>, in some embodiments the receptacles may be similar (e.g. see <FIG>). The second receptacle 31b may be aligned substantially parallel to the first receptacle 31a. Although not shown, the receptacles may not be parallel to each other in some embodiments. The second receptacle <NUM>1b may include a receiving slot <NUM> or be open to engage the primary fusion rod <NUM>, pedicle screw <NUM>, and/or portions of the pedicle screw system <NUM>. The slot <NUM> may intersect the second receptacle/through opening 31b having an axis A. As shown in <FIG>, the slot <NUM> receives the rod <NUM> (e.g. side-loading and/or laterally). The slot <NUM> may extend through an outer periphery <NUM> of the connector <NUM>. The slot <NUM> may extend through a lateral side 33a or outer periphery <NUM> for a depth intersecting with a front side 33b and a back side 33c of the connector <NUM>. The first receptacle 31a may be a through opening having an axis A. The through opening/first receptacle 31a may extend from the front side 33b to the back side 33c of the connector <NUM>. The front side 33b includes a front opening 31ac and the back side 33c includes a back opening 31ad defining the through opening therebetween. The front opening 31ac and/or back opening 31ad of the through opening/first receptacle 31a may be a slot or slot shaped. The slot shaped opening may receive (e.g. axially) the bushing <NUM> in one or more orientations, but not other orientations in some embodiments. The bushing <NUM> may be inserted into the front opening 31ac and/or back opening 31ad. The receptacles 31a, 31b may be a variety of shapes, sizes, quantities, positions, and constructions and still be within the scope of the invention.

In some implementations, the connector <NUM> may include or be defined as a fixed body 30a defining the receptacles 31a, 31b. The fastener <NUM> thereby reduces or impinges into the space defined by the receptacle/opening to engage the rod, bushing, and/or other structure within the receptacle.

In some implementations, the connector <NUM> may include one or more fasteners <NUM> securing the plurality of rods <NUM>, <NUM> together for a variety of applications. These fasteners <NUM> may include at least a first fastener 61a and a second fastener 61b. The connector <NUM> may include one or more threaded openings 34a, 34b threadably receiving the corresponding fastener 61a, 61b. The one or more threaded openings 34a, 34b may intersect with the one or more receptacles 31a, 31b. The threaded opening 34a, 34b may intersect with the receptacle 31a, 31b to receive the fastener <NUM> and/or additional structure to secure the rod <NUM>, <NUM>, screw <NUM>, and/or bushing <NUM>. As shown in <FIG>, a first threaded opening 34a intersects the first receptacle 31a. The first threaded opening 34a may extend from a top side 33d of the connector <NUM> into the first receptacle 31a. As such, the fastener <NUM> (e.g. first fastener 61a) may compress or threadably engage the first threaded opening 34a and/or bushing <NUM>, in a variety of orientations, within the first receptacle 31a to orient the received rods <NUM> desired orientation or application. The first fastener 61a may extend or project into the first receptacle 31a. The first fastener 61a may engage or compress the bushing <NUM> onto the rod <NUM>. Further, a second threaded opening 34b intersects the second receptacle 31b. The second threaded opening 34b may extend from the top side 33d of the connector into the second receptacle 31b. As such, the second fastener 61b engages or compresses the primary rod <NUM> or threadably engages the second threaded opening 34b. The second fastener 61b may extend or project into the second receptacle 31b and/or bushing <NUM>, if used in some embodiments. The first and second fastener 61a, 61b may engage their corresponding receptacle 31a, 31b, bushing <NUM>, and/or rod independently/separately from the other.

The one or more fasteners <NUM> may be a variety of constructions, quantities, shapes and sizes and still be within the scope of the invention. As shown in the Figures, the one or more fasteners <NUM> may be a locking or set screw engaging the threadable opening and/or compressing/engaging the rod, bushing, and/or pedicel screw.

The one or more bushings <NUM> may be a variety of joints to orientate the one or more rods. In the one embodiment shown, the bushing <NUM> may be a universal ball joint to allow movement in a plurality of directions/planes. The bushing <NUM> may be spherical as shown. The bushing <NUM> may include a slot <NUM>. The bushing <NUM> may include an indentation <NUM> proximal the top side 33d of the connector <NUM> to receive a portion of or a projection of the fastener <NUM> (e.g. set screw or first fastener 61a) to compress the bushing <NUM>. When engaged, the fastener <NUM> may lock the orientation/angle θ of the rod/bushing. Further, in some embodiments, the bushing <NUM> may include a second indentation <NUM>. The second indentation <NUM> may be opposite to the slot <NUM> of the bushing <NUM> and/or be located proximal the lateral side 33a of the connector <NUM>. The second indentation <NUM> may align with a through hole <NUM> of the connector <NUM> extending to and intersecting the first receptacle 31a (e.g. through opening/receptacle). The through hole <NUM> and the indentation <NUM> of the bushing <NUM> receives a portion of a pin <NUM> of the connector <NUM> to restrict at least some movement of the bushing <NUM> relative to the body 30a/receptacle 31a. For example, the pin <NUM> may reduce the removal of the bushing <NUM> from the first receptacle 31a. Moreover, the bushing <NUM> may be positioned in an annular groove 31ae within the first receptacle. As illustrated in <FIG>, the through hole <NUM> may intersect the internal annular groove 31ae receiving the outer periphery of the bushing <NUM> when in the assembled position (see <FIG> and <FIG>). The inner periphery of the bushing may define a through opening to receive the rod. As such, the opening or slots <NUM>, if used, may intersect with the through opening of the bushing. The bushing <NUM> may be a variety of shapes, sizes, quantities, positions, and constructions and still be within the scope of the invention.

As illustrated in <FIG>, the bushing <NUM> sis inserted into the first receptacle 31a/ opening in an orientation different from the orientation of the bushing when in the assembled position (e.g. see <FIG>) with the remaining portion of the connector. As shown in <FIG>, the bushing <NUM> includes a first orientation to be inserted into the front and/or back opening 31ac, 31ad (e.g. slot) of the first receptacle 31a. The first orientation may be substantially parallel to the direction of the axis A of the through opening of the first receptacle. Once inserted into the through opening or slot of the front/back opening and positioned proximate the annular groove 31ae, if used, the bushing may be pivoted (e.g. about <NUM> degrees) such that bushing is aligned/parallel to the annular groove or transverse to an axis A of the through opening/receptacle. Once pivoted to the second orientation or in the final assembled position within groove 31ae, the pin <NUM>, if used, may be inserted into the through hole <NUM> and subsequently the indentation <NUM> of the outer periphery of the bushing.

In some implementations, the one or more bushings <NUM> within the connector <NUM> may allow for variation of the orientation or angles θ of the one or more rods <NUM>, <NUM> in one or more planes and/or one or more directions. In the one embodiment as best shown in <FIG>, the bushing and/or rod <NUM> positioned within the bushing <NUM> may have an angle θ (e.g. up to about <NUM> degrees of angulation) in one or more planes from the axis of the receptacle or a cone of displacement (e.g. up to about <NUM> degrees) of the rod's axis Ar about the axis A may be used to vary the orientation of the rod. It should be understood that this cone of displacement or angulation may be, but is not limited to, anywhere from <NUM> to <NUM> degrees in all or certain planes of motion along the rods axis Ar in some embodiments. Moreover, for example, the cone of angulation about the axis A may be <NUM> degrees in some embodiments or applications. The displacement or angle θ of the rod in the application may be secured into position upon compression by the bushing/fastener within the threaded opening. In embodiments when two bushings <NUM> are used, for example in <FIG>, the two rods <NUM>, <NUM> may be a variety of angles θ within each corresponding receptacle/bushing to create a variety of angles between the adjacent/connected rods for a variety of applications. It should be understood that a variety of cones/angles or range of angles may be used to position the rod/bushing in one or more planes and still be within the scope of the invention. For example, the rod may be able to angle to a first angle/cone in one plane and a second or another angle/cone in another plane, where the first angle/cone may be different from the second angle/cone. (e.g. <NUM> degrees of cone angulation in the sagittal plane and <NUM> degrees of cone angulation in the coronal plane).

In some implementations, the connector <NUM> may include two or more variable connections to the one or more rods. As shown in the one embodiment in <FIG>, each receptacle 31a, 31b of the connector <NUM> includes the bushing <NUM> to receive the corresponding rod <NUM>, <NUM>. This one embodiment shown may receive or load both rods <NUM>, <NUM> axially into the front side 33b and/or back side 33c. The first receptacle 31a includes the first bushing <NUM> and the second receptacle 31b includes the second bushing <NUM>. Each rod <NUM>, <NUM> received by the bushing <NUM>, respectively, may be angled independently of the other rod. However, in some embodiments not shown, the first angle θ of one rod may be dependent on the other or second rod's angle θ.

In some implementations, the connector <NUM> may include a top-loading receptacle for receiving the rod. As shown in the one embodiment in <FIG>, the first receptacle 31a may include the bushing <NUM> and the second receptacle 31b may include a slot <NUM>. The second receptacle 31b may include the receiving slot <NUM> or be open to engage the rod <NUM>, pedicle screw <NUM>, and/or portions of the pedicle screw system <NUM>. The slot <NUM> receives the rod <NUM> (e.g. top-loading). The slot <NUM> may extend through the outer periphery <NUM> of the connector <NUM>. The slot <NUM> may extend through the top side 33d or outer periphery <NUM> for a depth intersecting with the front side 33b and the back side 33c of the connector <NUM>. As in the one embodiment illustrated in <FIG>, the slot <NUM> passes through or may be combined with the second threaded opening 34b to the second receptacle <NUM>1b/through opening. The second fastener 61b is threaded into the slot <NUM> and/or second threaded opening 34b to secure the rod <NUM> and/or pedicle screw, if used. Although not shown, a pedicle screw <NUM> or portions thereof may be received or captured within the second receptacle 31b along with the rod <NUM>. For example, the bottom side 33e of the connector <NUM> may have an opening to the second receptacle 31b to receive the pedicle screw <NUM>. Moreover, the connector <NUM> may be described as a moveable head to the pedicle screw <NUM>, if used.

In use, the implantable connector system <NUM> or portions thereof may be implanted into the surgical site or used in a variety of surgical clinical applications. The first rod <NUM> may be inserted into the first receptacle <NUM><NUM> a/first bushing <NUM> of the first connector <NUM>, <NUM>, <NUM>. The first rod <NUM> may be axially loaded into the first receptacle 31a of the connector <NUM>, <NUM>, <NUM>. The second rod <NUM> may be axially-loaded, top loaded, or side-loaded into the second receptacle 31b of the connector <NUM>, <NUM>, <NUM>. In some embodiments, the second receptacle 31b may include the slot <NUM>, <NUM> within the outer periphery <NUM> of the connector <NUM>, <NUM> to engage the rod. Or in some embodiments, a second bushing <NUM> may be received in the second receptacle 31b of the connector <NUM> to engage the rod <NUM>. When the rods are inserted into their respective slots <NUM>, <NUM>, bushings <NUM>, and/or receptacles 31a, 31b, the user may thread the fasteners <NUM> into engagement directly or indirectly (e.g. via the bushing and/or other structure) into contact with the rod. The first rod <NUM>/first bushing <NUM> may be displaced to a desired angle θ or orientation within the receptacle. The first fastener 61a (e.g. set or locking screw) may be threaded into the engagement with the first bushing <NUM> compressing the first rod <NUM> into a fixed position at one or more desired angles θ or orientations. For example, in some embodiments, the rod's axis Ar and/or bushing may be fixedly positioned at an angle θ (e.g. from about zero to about <NUM> degrees) from the axis A of the receptacle. The second fastener 61b (e.g. set or locking screw) may be threaded into the engagement with the second bushing <NUM>, if used, and/or the second rod <NUM>. If a second bushing <NUM> is used in the second receptacle 31b, the second rod <NUM>/second bushing <NUM>/remaining portion of the connector may be angled (e.g. angle θ) to a desired orientation. One or more additional or second connectors <NUM>, <NUM>, <NUM> may be used to connect the first and second rods <NUM>, <NUM>. Moreover, the first and second connectors may be the same or different in a variety of applications. Further, the first and second connectors may be different in shape, size, quantities, and construction (e.g. wider or narrower spacing between receptacles) to accommodate curvature of the one or more connected rods. For example, the axis A of each receptacle may not be parallel to each other in some embodiments. Moreover, the receptacles and/or bushings of one or more connectors may include an inner periphery to accommodate a variety of rod dimensional/construction characteristics (e.g. different diameters). The system <NUM>, <NUM>, in some embodiments, may include one or more pedicle screws attached to the one or more rods and/or connectors. In use, one or more pedicle screws <NUM> may be implanted into the surgical site. The pedicle screws may include a moveable head to secure to one or more rods. In some embodiments, the connector may include the pedicle screw. In some embodiments, the one or more bushings <NUM> may be inserted by one or more users into the one or more receptacles 31a, 31b. In various embodiments, the bushing <NUM> is axially inserted in the receptacle in the first orientation (e.g. see <FIG>) different from the final or second orientation(s) (e.g. see <FIG>) when installed or assembled into the connector/receptacle. Once the bushing is inserted into the receptacle, in some embodiments, the bushing <NUM> is pivoted (e.g. <NUM> degrees) from the first orientation to the second orientation to receive the rod. In some embodiments, the pin <NUM> may be inserted into the connector to retain the bushing therein.

Claim 1:
An implantable connector system (<NUM>) comprising:
a connector (<NUM>) having a first receptacle (31a), a second receptacle (31b), and a first bushing (<NUM>) received in the first receptacle, and wherein the connector includes a first threaded opening (34a) intersecting the first receptacle and a second threaded opening (34b) intersecting the second receptacle;
wherein the first receptacle includes an axis extending from a front side (33b) to a back side (33c) of the connector, wherein the first bushing is axially loaded along the first axis of the first receptacle in a first orientation and pivoted to a second orientation different from the first orientation;
a first rod matingly received within the first bushing when the first bushing is orientated in the second orientation;
a second rod matingly received within the second receptacle;
a first fastener (61a) configured to threadably engage the first threaded opening; and
a second fastener (61b) configured to threadably engage the second threaded opening.