Rod-to-rod connector implant

Abstract

Disclosed herein is a rod-to-rod connector implant configured to join a first rod and a second rod in a spinal fixation procedure. In various embodiments, disclosed herein are a rod-to-rod connector implant, a spinal fixation system comprising such a rod-to-rod connector implant, a first rod, and a second rod joined or coupled to the first rod by the connector implant, a method of inserting the rod-to-rod connector implant, and a kit comprising the rod-to-rod connector implant and a pair of forceps configured for use in inserting the connector implant into a patient.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This patent application claims priority to U.S. Provisional Patent Application No. 63 / 303,469, filed January 26, 2022.

[0002] (Technical field) The present invention relates generally to connector implants for use in spinal fixation procedures. More particularly, the present invention relates to rod-to-rod connector implants having a single closure mechanism, as well as systems, insertion methods, and kits including such rod-to-rod connector implants. [Background technology]

[0003] A fixation system may be surgically inserted to achieve and / or maintain a desired spatial relationship between bones, such as between vertebrae in a patient's spine. A typical fixation system may include fixation elements, such as rods, which may be coupled to vertebrae by bone anchors. In the treatment of certain conditions, it may be desirable to couple a first rod to a second rod. For example, a procedure may involve coupling two or more rods laterally or medially for added strength and support or to add length to the construct. Other procedures may involve revision of a previous fixation procedure and extending a previously inserted construct to additional vertebral levels. This may involve, for example, coupling a second rod laterally or medially to an existing first rod to allow for anterior or posterior extension of the construct.

[0004] Typically, rod-to-rod connector implants used for such rod-to-rod connections have openings in the posterior direction to facilitate placing the rod from the top and fixing it in place with a locking screw. This loading mechanism poses a challenge when adding a connector to an existing construct in revision surgeries, since the rod position is already fixed in the patient. In order to add the fixation element in these revision surgeries, the existing construct must be partially removed, which increases the procedure time and the patient's recovery time. There is a need for a rod-to-rod connector implant that addresses these challenges. Summary of the Invention

[0005] A first aspect of the present disclosure provides an inter-rod connector implant for joining a first rod and a second rod. The implant comprises a connector body including a first rod channel and a second rod channel, the first rod channel opening on an opposite side of the connector body from the second rod channel, and the first rod channel offset outwardly from the second rod channel. The connector body further includes a recess extending through the connector body between the first and second rod channels. The implant further includes a locking member movably coupled to the connector body, the locking member located at least partially within the recess and extending into the first and second rod channels, and a closure member for engaging a socket in the second rod channel. In the locked position, the closure member functions as a single locking mechanism for retaining the first rod in the first rod channel and the second rod in the second rod channel.

[0006] In certain embodiments, the rod-to-rod connector implant is configured to join or attach a second rod to a first rod, either medially or laterally. The first rod may be new or may be part of an existing construct. If the first rod is part of an existing construct, the rod-to-rod connector implant facilitates joining of the second rod to the first rod without the need to disassemble the existing construct, allowing for revision without removing the existing construct.

[0007] In certain embodiments, in the unlocked position, the locking member allows the first rod to be received in the first rod channel and the second rod to be received in the second rod channel. In the locked position, the closure member engages the socket to hold the second rod in the second rod channel, and a force applied by the second rod to the second rod contact surface of the locking member holds the first rod in the first rod channel. The locking member may further include a first rod locking surface configured to extend into the first rod channel in the locked position to hold the first rod in the first rod channel. The locking member may further include a retention feature disposed at a distal end of the second rod contact surface. The body may further include a shoulder disposed proximate a bottom of the socket, the shoulder configured to engage the retention feature in the unlocked position.

[0008] In certain embodiments, the locking member may be pivotally coupled to the connector body. A first bore may be disposed through a thickness of the connector body through a portion of the recess and a second bore may be disposed through a thickness of the locking member. The first and second bores may be aligned with one another, the connecting member may be disposed within the first and second bores, and the locking member may pivot about the connecting member to move or toggle between an unlocked position and a locked position.

[0009] In certain embodiments, the first rod channel opens to a bottom surface of the connector body and the second rod channel opens to a top surface of the connector body, the first rod channel being substantially parallel to the second rod channel. The recess may further open to a bottom surface of the connector body and may open to the second rod channel at its bottom.

[0010] In a particular embodiment, the socket is a guide and advancement structure and the closure member includes a locking cap. The guide and advancement structure may also be a spirally wound flange feature.

[0011] In a specific embodiment, the connector body, the locking member, the connecting member, and the closure member each comprise titanium.

[0012] A second aspect of the present disclosure provides a system comprising a first rod, a second rod, and an inter-rod connector implant coupling the first rod to the second rod. The connector implant comprises a connector body including a first rod channel and a second rod channel, the first rod channel opening on an opposite side of the connector body from the second rod channel and offset outwardly from the second rod channel, and a recess extending through the connector body between the first and second rod channels. The connector implant further comprises a locking member movably coupled to the connector body, the locking member positioned at least partially within the recess and extending into the first and second rod channels, and a closure member for engaging a socket in the second rod channel. In a locked position, the closure member functions as a single locking mechanism for retaining the first rod in the first rod channel and the second rod in the second rod channel.

[0013] In certain embodiments, the first rod may be an index rod or an extension rod, and the second rod may be an extension rod. The first and second rods may each have a circular cross section and an outer diameter that may be selected independently from the outer diameter of the other rod, which in certain embodiments may be about 3.5 mm to about 4.0 mm.

[0014] A third aspect of the present disclosure provides a method of inserting a rod-to-rod connector implant, the method including: a) providing a rod-to-rod connector implant including: a connector body having a first rod channel and a second rod channel, the first rod channel opening on an opposite side of the connector body from the second rod channel and offset outwardly from the second rod channel; a recess extending through the connector body between the first and second rod channels; a locking member movably coupled to the connector body, the locking member positioned at least partially within the recess and extending into the first and second rod channels; and a closure member for engaging a socket in the second rod channel. The method further includes b) inserting the connector body over the first rod using forceps such that the first rod is disposed within the first rod channel, the first rod being fixed in position within the patient; c) inserting the second rod into the second rod channel from an opposite side of the connector body; d) actuating movement of the locking member at least partially out of the second rod channel such that the second rod contacts a second rod contact surface of the locking member and the first rod locking surface extends into the first rod channel, thereby retaining the first rod within the first rod channel; and e) inserting a closure member into the socket to lock the rod-to-rod connector implant onto the first and second rods using a single locking mechanism.

[0015] In certain embodiments, step b) may further include inserting the connector body downwardly onto the first rod, with the first rod channel opening to a bottom surface of the connector body.

[0016] In certain embodiments, step c) may further include inserting a second rod downwardly into the second rod channel, the second rod channel opening to a top surface of the connector body.

[0017] In certain embodiments, step e) may further include inserting the closure member downwardly into the socket, the socket being disposed at an opening of the second rod channel in the top surface of the connector body.

[0018] In certain embodiments, the first rod may be an index rod or an extension rod, and the second rod may be an extension rod.

[0019] A fourth aspect of the present disclosure provides a kit comprising a rod-to-rod connector implant and a pair of forceps configured for use in inserting the rod-to-rod connector implant into a patient. The rod-to-rod connector implant includes a connector body having a first rod channel and a second rod channel, the first rod channel opening on an opposite side of the connector body from the second rod channel, the first rod channel being offset outwardly from the second rod channel. The connector body further includes a recess extending through the connector body between the first rod channel and the second rod channel, and a pair of depressions having a shape and size complementary to and configured to matingly engage tips of the forceps. The connector implant further includes a locking member movably coupled to the connector body, the locking member at least partially positioned within the recess of the connector body and extending into the first rod channel and the second rod channel, and a closure member for engaging a socket in the second rod channel. In the locked position, the closure member functions as a single locking mechanism to retain the first rod in the first rod channel and the second rod in the second rod channel.According to this aspect of the disclosure, the forceps has a tip that complementarily mates with a pair of recesses.

[0020] In certain embodiments, in the unlocked position, the locking member allows a first rod to be received in the first rod channel and a second rod to be received in the second rod channel, and in the locked position, the closure member engages the socket to retain the second rod in the second rod channel, and a force applied by the second rod to the second rod contact surface of the locking member retains the first rod in the first rod channel. The locking member may further include a first rod locking surface configured to extend into the first rod channel in the locked position to retain the first rod in the first rod channel.

[0021] In certain embodiments, the locking member further includes a retention feature disposed at a distal end of the second rod contact surface, the body further including a shoulder disposed proximate a bottom of the socket, the shoulder configured to engage the retention feature in the unlocked position.

[0022] In certain embodiments, the locking member is pivotally coupled to the connector body. A first bore may be provided through a thickness of the connector body and through a portion of the recess, and a second bore may be provided through a thickness of the locking member and aligned with the first bore. A connecting member may be disposed within the first and second bores such that the locking member pivots about the connecting member to move or toggle between an unlocked position and a locked position, as further disclosed herein.

[0023] In certain embodiments, the first rod channel opens to a bottom surface of the connector body and the second rod channel opens to a top surface of the connector body, the first rod channel being substantially parallel to the second rod channel. The recess may further open to a bottom surface of the connector body and may open to the second rod channel at its bottom.

[0024] In a particular embodiment, the socket is a guide and advancement structure and the closure member is a locking cap. The guide and advancement structure may also be a spirally wound flange feature.

[0025] In a specific embodiment, the connector body, the locking member, the connecting member, and the closure member each comprise titanium.

[0026] These and other aspects, advantages and salient features of the present invention will become apparent from the following detailed description, which discloses embodiments of the invention when considered in conjunction with the accompanying drawings, in which like parts are designated with like reference characters throughout. [Brief description of the drawings]

[0027] [Figure 1] FIG. 1 illustrates an exploded perspective view of a rod-to-rod connector implant, according to one embodiment of the present invention. [Diagram 2] FIG. 1 illustrates a perspective view of a rod-to-rod connector implant according to one embodiment of the present disclosure. [Diagram 3] FIG. 1 illustrates a perspective view of a rod-to-rod connector implant according to one embodiment of the present disclosure. [Figure 4] FIG. 2 is a side cross-sectional view of a rod-to-rod connector implant and a first rod, according to an embodiment of the present invention. [Diagram 5] FIG. 2 is a side cross-sectional view of a rod-to-rod connector implant and a first rod, according to an embodiment of the present invention. [Figure 6] FIG. 13 is a side cross-sectional view of a portion of a rod-to-rod connector implant including a locking member retention mechanism, according to one embodiment of the present invention. [Figure 7] FIG. 1 illustrates a side view of a portion of a rod-to-rod connector implant including a locking member retention mechanism, according to an embodiment of the present invention. [Figure 8] FIG. 13 is a bottom view of a portion of a rod-to-rod connector implant including a locking member retention mechanism, according to one embodiment of the present invention. [Figure 9] FIG. 13 is a side cross-sectional view of a portion of a rod-to-rod connector implant including a locking member retention mechanism, according to one embodiment of the present invention. [Figure 10] FIG. 1 is a perspective view of a spinal fixation system including a first rod in a locked position, a second rod, and an inter-rod connector implant according to an embodiment of the present invention. [Figure 11] FIG. 1 is a side view of a spinal fixation system including a first rod in a locked position, a second rod, and an inter-rod connector implant according to an embodiment of the present invention. [Figure 12] FIG. 1 is a perspective view of kit components including a rod-to-rod connector implant and forceps for its insertion, according to an embodiment of the present invention. [Figure 13] FIG. 1 is a perspective view of kit components including a rod-to-rod connector implant and forceps for its insertion, according to an embodiment of the present invention.

[0028] It should be noted that the drawings of the disclosure are not necessarily to scale. The drawings are intended to depict only typical aspects of the disclosure, and therefore should not be considered as limiting the scope of the disclosure. In the drawings, like numbers represent like elements between the drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] As discussed above, aspects of the invention provide a rod-to-rod connector implant (or "connector implant") for joining a first rod and a second rod, as well as a spinal fixation system comprising such an inter-rod connector implant, a first rod, and a second rod joined or coupled to the first rod by the connector implant, a method of inserting the inter-rod connector implant, and a kit comprising the rod-to-rod connector implant and a pair of forceps configured for use in inserting the connector implant into a patient.

[0030] As used herein, the terms proximal and distal are defined with respect to locking member 120 (FIG. 1). The proximal direction is shown in FIG. 1 as direction P and refers to the direction in which locking member 120 extends toward and into first rod channel 1101. The distal direction is shown in FIG. 1 as direction D and is the opposite direction to the proximal direction and refers to the direction in which locking member 120 extends toward and into second rod channel 1102.

[0031] As discussed above, aspects of the invention provide a rod-to-rod connector implant 100 (FIGS. 1-9) for joining a first rod 210 and a second rod 220 (FIGS. 10-11). According to various embodiments disclosed herein, the implant 100 includes a connector body 110. The connector body 110 includes a first rod channel 1101 configured to receive the first rod 210 and a second rod channel 1102 configured to receive the second rod 220. The first rod channel 1101 may be substantially parallel to the second rod channel 1102, and the second rod channel 1102 may be offset outwardly from the first rod channel 1101 within the connector body 110. The first rod channel 1101 is further configured to open to an opposite side 1108 of the connector body 110 from a side 1109 where the second rod channel 1102 opens, and the first rod 210 enters the first rod channel 1101 from the opposite side 1108 of the connector body 110 from the side 1109 where the second rod 220 enters the second rod channel 1102. The side 1108 where the first rod channel 1101 opens may be considered the bottom of the connector body 110, and the side 1109 where the second rod channel 1102 opens may be considered the top of the connector body 110.

[0032] The connector body 110 further includes a recess 1104 disposed therein. The recess 1104 may take the form of a hollowed-out portion in the connector body 110. The recess 1104 extends through the connector body 110 and spans the distance between the first rod channel 1101 and the second rod channel 1102. Thus, the recess 1104 opens to the first rod channel 1101 at a proximal end and opens to the second rod channel 1102 at its distal end. The recess 1104 may also be at least partially open to the same side 1108 of the connector body 110 as the first rod channel 1101 (see, e.g., FIGS. 3, 8 ), e.g., to the bottom of the connector implant 100. In certain embodiments, the recess 1104 may additionally be at least partially open to, or may include, an opening 1111 (FIGS. 1-3) on the same side 1109 of the connector body 110 as the second rod channel 1102. The side 1109 of the connector body 110 into which the second rod channel 1102 and the recess 1104 open may be considered the top of the connector implant 100.

[0033] The connector implant 100 further includes a locking member 120 movably coupled to the connector body 110. The locking member 120 is at least partially disposed within the recess 1104 of the connector body 110. The locking member 120 extends proximally into the first rod channel 1101 and extends distally into the second rod channel 1102. The locking member 120 may include a first rod locking surface 1203 configured to extend into the first rod channel 1101 in a locked position to retain the first rod 210 within the first rod channel 1101. The locking member 120 may further include a retention feature 1205 disposed at a distal end of the second rod contact surface 1204. The interaction of the retention feature 1205 with the connector body 110 is further described herein.

[0034] The locking member 120 may be movably coupled to the connector body 110. FIG. 1 illustrates an embodiment in which the connector body 110 may include a first bore 1103 through its thickness. The first bore 1103 may penetrate the connector body 110 in a direction that is substantially perpendicular to the proximal / distal direction and substantially parallel to the orientation of the first rod channel 1101. The first bore 1103 may further penetrate a portion of the connector body 110 hollowed out to form the recess 1104 such that the first bore 1103 penetrates a wall of the connector body 110 that defines the recess 1104. The locking member 120 may include a second bore 1202 through its thickness. Similar to the first bore 1103, the second bore 1202 may penetrate the locking member 120 in a direction that is substantially perpendicular to the proximal / distal direction and is substantially parallel to the first rod channel 1101 when installed. The second bore 1202 may be disposed in a head portion 1201 ( FIG. 1 ) of the locking member 120, relative to which the locking member 120 moves or pivots in use. When the locking member 120 is located in the recess 1104, the second bore 1202 is aligned with the first bore 1103. The connecting member 130 may then be disposed in the first bore 1103 and the second bore 1202, such that the locking member 120 pivots about the connecting member 130 to move or toggle between an unlocked position and a locked position. The connecting member 130 may be, for example, a pin.

[0035] In other embodiments, the connection between the locking member 120 and the connector body 110 may take some other form. In one embodiment, the connecting member 130 may be integrally formed with the locking member 120, particularly the head portion 1201 of the locking member 120. In one such embodiment, the recess 1104 in the connector body 110 may open to the top surface 1109 of the connector body 110, and the locking member 120 with the integrally formed connecting member seats in the connector body 110 via the opening 1111 in the top surface 1109 of the connector body 110, allowing the locking member 120 to rotate about the T-shaped integral connecting member(s). In other embodiments, the locking member 120 may be disposed in a track (not shown) in the connector body 110. In one such embodiment, the locking member 120 may translate proximally / distally along a track in the connector body 110 rather than pivoting relative to the connecting member 130. In still further embodiments, the connector body 110 may include a flexible portion configured to bend into the first rod channel 1101 and into the first rod 210 when pushed by the second rod 220 in the second rod channel 1102.

[0036] The connector implant 110 further includes a fixation or closure member 140 for engaging the socket 1105. The socket 1105 is disposed at or near the opening of the second rod channel 1102 and is configured to receive the fixation or closure member 140.

[0037] When the connector implant 100 is in the unlocked position (e.g., FIG. 2), the locking member 120 is positioned within the recess 1104 in a manner that does not obstruct the first rod channel 1101 or the second rod channel 1102, thus allowing or enabling the first rod 210 to be received within the first rod channel 1101 and the second rod 220 to be received within the second rod channel 1102.

[0038] When the connector implant 100 is in the locked position (FIGS. 4-5, 11), the closure member 140 functions as a single locking mechanism to retain the first rod 210 in the first rod channel 1101 and the second rod 220 in the second rod channel 1102. In certain embodiments, in the locked position, the closure member 140 engages the socket 1105 to retain the second rod 220 in the second rod channel 1102 retained in the second rod channel 1102 between the closure member 140 and the second rod contact surface 1204. In this position, the force applied by the second rod 220 to the second rod contact surface 1204 of the lock member 120 acts to retain the position of the lock member 120 where the first rod 210 is retained in the first rod channel 1101. In some embodiments, the socket 1105 may be in the form of a guide and advancement structure, and more specifically, may be a spirally wound flange feature. The closure member 140 may be in the form of a locking cap.

[0039] 4, in one embodiment, a locking member biasing element 1301 is further provided. The locking member biasing element 1301 may be configured to bias the locking member 120, for example, to move or pivot into the first rod 210 with a constant force relative to the connecting member 130. The locking member biasing element 1301 may be, for example, a leaf spring configured to apply a force to the locking member 120 to rotate toward the first rod channel 1101 and the first rod 210. The spring force applied by the locking member biasing element 1301 may be sufficient to maintain a friction fit between the first rod 210 and the connector implant 100, for example, between the first rod locking surface 1203 of the locking member 120 and the first rod channel 1101 of the connector body 110. The spring force applied by the locking member biasing element 1301 may be configured to be overcome by a force loading the connector implant 100 onto the first rod 210, i.e., a force inserting the first rod 210 into the first rod channel 1101. Upon application of such a loading force, the force applied by the locking member biasing element 1301 will be overcome and the locking member 120 will move or pivot, for example, about the connector member 130, at least partially out of the first rod channel 1101. Once the first rod 210 is located within the first rod channel 1101, the locking member 120 is configured to move, pivot, or snap back towards the first rod 210 to provide a tight friction fit between the first rod 210 and the connector implant 100. As shown in FIG. 4, the locking member biasing element 1301 is disposed adjacent to the second rod channel 1102 and the socket 1105, however, in other embodiments, the locking member biasing element 1301 may be disposed anywhere that allows a biasing force to be applied to the locking member 120 toward the first rod channel 1101.

[0040] 5, in another embodiment, a first rod biasing element 1401 is provided. The first rod biasing element 1401 is configured to bias the first rod 210 into the locking member 120 with a constant force. The first rod biasing element 1401 may be, for example, a spring-loaded plunger disposed in a bore 1110 in the connector body 110 that opens into the first rod channel 1101. The bore 1110 may be disposed proximal to the first rod channel 1101 and may be substantially opposite the first rod contact surface 1203 such that when the first rod 210 is fully seated in the first rod channel 1101, the first rod biasing element 1401 biases the first rod 210 into the first rod contact surface 1203 of the locking member 120. This configuration is configured to prevent the locking member 120 from moving or pivoting, for example, about the connecting member 130 toward the first rod 210 more than a certain distance, thus forcing the first rod 210 between the first rod biasing element 1401 and the locking member 120.

[0041] In certain embodiments, a retention feature of the locking member 120 may be provided. The retention feature may be configured to be overcome by a force applied to the locking member 120 by the second rod 220. For example, with reference to FIG. 6, the connector body 110 may include a ledge or shoulder 1106 that may be disposed near or proximal to a bottom or deepest point of the socket 1105 and the second rod channel 1102. The locking member 120 may be provided with a corresponding retention feature 1205, which may take the form of, for example, a nodule, beam, or other protrusion configured to engage the shoulder 1106. In the unlocked position, the retention feature 1205 of the locking member 120 is configured to engage or rest against the shoulder 1106. The shoulder 1106 may be configured to flex out of the way under a force applied to the locking member 120, for example biasing the locking member 120 to move or pivot toward and / or into the first rod channel 1101 relative to the connecting member 130. In various embodiments, the shoulder 1106 may be permanently deformed or may be sufficiently flexible to accommodate the retention feature 1205 and then flex backwards under a force applied to the locking member 120. The retention feature 1205, and its engagement with the shoulder 1106, acts to retain the position of the locking member 120 and prevents the locking member 120 from prematurely moving or pivoting proximally toward or into the first rod channel 1201, which may have the effect of preventing insertion of the first rod 210 into the first rod channel 1101.

[0042] In another embodiment shown in FIGS. 7-8, the retention mechanism of the locking member 120 may be provided in the form of a small weld 1501 between the connector body 110 and the locking member 120. The weld 1501 may be configured to break when a force above a certain threshold is applied. Thus, the weld 1501 may hold the locking member 120 in the unlocked position until a force above the threshold is applied to the weld 1501 by inserting the first rod 210 into the first rod channel 1101 and pushing the connector body 110 downward onto the first rod 210. In other embodiments, a force above the threshold may be applied to the weld 1501 by the second rod 220 pushing the locking member 120.

[0043] In further embodiments, swaging may be used to create the retention feature. Referring to FIG. 9, a blind drilled hole 1601 may be provided on the distal exterior surface of the connector body 110. A punch tool may be used at the blind drilled hole 1601 to deform the material of the connector body 110 and force the material into the locking member 120 when held in a particular orientation. The process may be configured to create a wedge just proximal to the blind drilled hole 1601. The wedge will be forced distally back into the blind drilled hole 1601 and out of the way of the locking member 120 when sufficient force is applied to rotate the locking member 120.

[0044] In various embodiments, the connector body 110, the locking member 120, the connecting member 130, if present, and the closure member 140 each include titanium in their composition.

[0045] 10-11, as previously indicated, embodiments of the present invention provide a system 200 configured for use in orthopedic fixation applications, such as spinal fixation. System 200 may include a first rod 210, a second rod 220, and a rod-to-rod connector implant 100 configured to couple first rod 210 to second rod 220.

[0046] Various embodiments of rod-to-rod connector implants are described herein with respect to Figures 1-9. It is understood that the system 200 includes a connector implant 100 according to any embodiment described herein that may be used to couple a first rod 210 to a second rod 220.

[0047] Each of the first rod 210 and the second rod 220 may have a circular cross-sectional shape and may further have an outer diameter that may vary depending on the particular application. For example, each of the first rod 210 and the second rod 220 may have an outer diameter of about 3.5 mm to about 4.0 mm. Such dimensions may be suitable for cervical applications, for example. However, in other embodiments, the first rod 210 and the second rod 220 may have other dimensions. For example, each of the first rod 210 and the second rod 220 may have an outer diameter greater than about 3.5 mm to about 4.0 mm, for use in, for example, thoracic-lumbar applications, as known in the art. Regardless of the particular dimensions, each of the first rod channel 1101 and the second rod channel 1102 may be configured to accept rods 210, 220 of two or more diameters within the slot. For example, each of the rod channels 1101, 1102 may be configured to accept, for example, either 3.5 mm or 4.0 mm rods. Additionally, the first rod 210 does not have to have the same outer diameter as the second rod 220, and vice versa. The first rod 210 and the second rod 220 may further comprise a metallic material, such as, for example, titanium, a titanium alloy, stainless steel, etc., as is known in the art.

[0048] In certain embodiments, the connector implant 100 may be used as part of a system 200 for use in a surgical revision procedure. In such embodiments, the first rod 210 is an index rod that is part of an existing construct, and the second rod 220 is an extension rod. The connector implant 100 can be loaded onto the existing index rod 210, and the index rod 210 can be coupled to the second extension rod 220 and built onto the existing construct without requiring surgical removal of the existing components. In other embodiments, the connector implant 100 may be used as part of a system 200 for use in a primary surgical procedure. In such embodiments, both the first rod 210 and the second rod 220 are extension rods or new rods. The connector implant 100 may be loaded onto the first rod 210 after its insertion, and the second rod 220 may be subsequently inserted and secured into the second rod channel 1102.

[0049] As previously indicated, aspects of the present invention provide a method of inserting a rod-to-rod connector implant 100, for example in a spinal fusion procedure application. According to various embodiments, the method may include the following steps. a) Providing a rod-to-rod connector implant 100 having a connector body 110, a locking member 120, a fixation member 140, and other features depending on the particular embodiment, as described in this specification with reference to any of Figures 1-9 and / or as illustrated in any of Figures 1-9. b) Using forceps 150 (FIGS. 12-13), inserting or loading the connector implant 100, specifically the connector body 110, onto the first rod 210 such that the first rod 210 is disposed within the first rod channel 1101, as shown in FIGS. 10-11. This step may include inserting the connector body 110 downwards onto the first rod 210, with the first rod channel 1101 opening to a bottom surface of the connector body 110. The first rod 210 may already be fixed in place within the patient, and as previously mentioned, may be either an index rod or an extension rod depending on the nature of the procedure. c) inserting a second rod 220 into the second rod channel 1102 of the connector body 110 from the opposite side of the connector body 110. The second rod 220 may be an extension rod, as described above. The second rod 220 may be inserted downward into the second rod channel 1102, which opens to the top surface of the connector body 110. d) contacting the second rod 220 with the second rod contact surface 1204 of the locking member 120 and actuating movement of the locking member 120 at least partially out of the second rod channel 1102. This movement causes the first rod locking surface 1203 to extend into the first rod channel 1101, thereby retaining the first rod 210 within the first rod channel 1101. e) inserting the closure member 140 into the socket 1105 in the second rod channel 1102 to lock the rod-to-rod connector implant 100 onto the first rod 210 and the second rod 220 with a single locking mechanism. The closure member 140 may be inserted downward into the socket 1105, which may be disposed at the opening of the second rod channel 1102 on the top surface of the connector body 110.

[0050] Depending on the embodiment, additional steps may be performed to accommodate the features described in more detail above with respect to the connector implant 100. For example, if the method begins with providing a connector implant 100 including a first rod biasing element 1401 as shown in FIG. 5 between steps a) and b), in certain embodiments, the first rod biasing element 1401 may be inserted into the bore 1110 or the presence of the first rod biasing element 1401 in the bore 1110 may be confirmed prior to loading the connector implant 100 onto the first rod 210. In other examples, if the method begins with providing a connector implant 100 including a retention feature as shown in FIG. 9, swaging as described herein may be performed prior to step b).

[0051] 12-13, as previously indicated, an embodiment of the present invention provides a kit for use in spinal fixation applications. The kit may include a rod-to-rod connector implant 100 and a pair of forceps 150 configured for use in inserting the rod-to-rod connector implant into a patient as described above.

[0052] Various embodiments of rod-to-rod connector implants are described herein with respect to Figures 1-9. The kits disclosed herein are understood to include a connector implant 100 according to any embodiment described or illustrated herein.

[0053] As provided in the kits disclosed herein, the rod-to-rod connector implant 100 includes a connector body 110 having a first rod channel 1101 and a second rod channel 1102, the first rod channel 1101 opening on an opposite side of the connector body from the second rod channel 1102. The first rod channel 1101 is offset outwardly from the second rod channel 1102 as described herein. The first rod channel 1101 may open to a bottom surface of the connector body 110, while the second rod channel 1102 may open to a top surface of the connector body 110. The first rod channel 1101 is aligned to be substantially parallel to the second rod channel 1102. A recess 1104 is provided through the connector body between the first rod channel 1101 and the second rod channel 1102. The recess 1104 may open to a bottom surface of the connector body and to a second rod channel 1102 at its bottom.

[0054] The connector implant 100 provided in the kit further includes a locking member 120 movably coupled to the connector body 110. As previously described, the locking member 120 is at least partially located within the recess 1104 and extends into the first rod channel 1101 and the second rod channel 1102. The locking member 120 may further include a first rod locking surface 1203 configured to extend into the first rod channel 1101 in a locked position to retain the first rod 210 within the first rod channel 1101. The locking member 120 is movably coupled to the connector body 110, and in certain embodiments may be pivotally coupled thereto.

[0055] In certain embodiments, the first bore 1103 may be disposed through a thickness of the connector body 110. The first bore 1103 may, among other things, extend through a portion of the recess 1104 and through a sidewall of the connector body 110 that defines the recess 1104. The second bore 1202 may be disposed through a thickness of the head portion 1201 of the locking member 120. The first bore 1103 and the second bore 1202 may be aligned with one another. The connecting member 130 may be disposed within the first bore 1103 and the second bore 1202 such that the locking member 120 pivots about the connecting member 130 to move or toggle between an unlocked position and a locked position. However, as previously described herein, other means of movably coupling the connector body 110 to the locking member 120 described elsewhere herein are considered part of the present invention as well.

[0056] The closure member 140 is provided for engaging a socket 1105 in the second rod channel 1102. The socket 1105 may be a guide and advancement structure, or more specifically, a spirally wound flange feature. The closure member 140 may specifically be a locking cap.

[0057] In the locked position, the closure member 140 functions as a single locking mechanism to retain the first rod 210 in the first rod channel 1101 and the second rod 220 in the second rod channel 1102. In particular, the closure member 140 may engage the socket 1105 to retain the second rod 220 in the second rod channel 1102. The force applied by the second rod 220 to the second rod contact surface 1204 of the locking member 120 further retains the first rod 210 in the first rod channel 1101.

[0058] In the unlocked position, the locking member 120 can allow a first rod to be received within the first rod channel 1101 and a second rod 220 to be received within the second rod channel 1102.

[0059] In certain embodiments, the connector implant 100 includes a retention mechanism. In particular, as described above with respect to FIG. 6, the locking member 120 may include a retention feature 1205 disposed at a distal end of the second rod contacting surface 1204, and the connector body 110 may further include a shoulder 1106 configured to engage the retention feature 1205 in the unlocked position. A connector implant 100 including a retention mechanism as described above with respect to any of FIGS. 6-8 may also be provided in association with a kit.

[0060] The connector body may further include a pair of recesses 1107 (FIGS. 1-3, 7, and 10-11). The forceps 150 includes a tip 152 (FIG. 12) that complementarily mates with the pair of recesses 1107. That is, the recess 1107 has a shape and size configured to matingly engage with the tip of the forceps 150 (FIGS. 12-13).

[0061] In various embodiments, the connector body 110, the locking member 120, the connecting member 130, if present, and the closure member 140 each include titanium in their composition.

[0062] As used herein, terms such as "first", "second", and the like do not denote an order, quantity, or importance, but rather are used to distinguish one element from another, and the terms "a" and "an" herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. The modifier "about" used in connection with a quantity is inclusive of the recited value and has the meaning indicated by the context (e.g., including the degree of error associated with measurement of the particular quantity). The suffix "(s)" as used herein is intended to include both the singular and the plural of the term it modifies, thereby including one or more of that term (e.g., metal(s) includes one or more metals). Ranges disclosed herein are inclusive and independently combinable (e.g., the range "up to about 25 mm, or, more specifically, about 5 mm to about 20 mm" includes the endpoints and all intermediate values ​​of the range "about 5 mm to about 25 mm", etc.).

[0063] While various embodiments are described herein, it will be appreciated by one skilled in the art that various combinations, modifications, or improvements of the elements can be made without departing from the scope of the present invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is not intended that the invention be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but the invention is intended to include all embodiments falling within the scope of the appended claims.

Claims

1. 1. An inter-rod connector implant for joining a first rod and a second rod, comprising: A connector body, a first rod channel and a second rod channel, the first rod channel opening on an opposite side of the connector body from the second rod channel, the first rod channel being offset outwardly from the second rod channel; a first rod channel and a second rod channel; a recess extending through the connector body between the first rod channel and the second rod channel. A connector body, a locking member movably coupled to the connector body, the locking member positioned at least partially within the recess and extending into the first rod channel and the second rod channel; a closure member for engaging a socket in the second rod channel; In a locked position, the closure member functions as a single locking mechanism to retain the first rod in the first rod channel and the second rod in the second rod channel. Rod-to-rod connector implant.

2. 2. The rod-to-rod connector implant of claim 1, wherein in an unlocked position, the locking member allows the first rod to be received within the first rod channel and the second rod to be received within the second rod channel.

3. 3. The rod-to-rod connector implant of claim 2, wherein in the locked position, the closure member engages the socket to retain the second rod in the second rod channel, and a force applied by the second rod to a second rod contact surface of the locking member retains the first rod in the first rod channel.

4. 4. The rod-to-rod connector implant of claim 3, wherein the locking member further comprises a first rod locking surface configured to extend into the first rod channel in the locked position to retain the first rod within the first rod channel.

5. the locking member further includes a retention feature disposed at a distal end of the second rod contact surface; The body further includes a shoulder disposed adjacent a bottom of the socket, the shoulder configured to engage the retention feature in the unlocked position.

4. The rod-to-rod connector implant of claim 3.

6. The rod-to-rod connector implant of claim 1 , wherein the locking member is pivotally coupled to the connector body.

7. a first bore extending through a thickness of the connector body and through a portion of the recess; a second bore through the thickness of the locking member and aligned with the first bore; 7. The rod-to-rod connector implant of claim 6, further comprising a connecting member disposed within the first bore and the second bore, such that the locking member pivots about the connecting member to move between an unlocked position and the locked position.

8. 2. The rod-to-rod connector implant of claim 1, wherein the first rod channel opens to a bottom surface of the connector body and the second rod channel opens to a top surface of the connector body, the first rod channel being substantially parallel to the second rod channel.

9. The rod-to-rod connector implant of claim 8 , wherein the recess opens to the bottom surface of the connector body and opens to the second rod channel at its bottom.

10. The rod-to-rod connector implant of claim 1 , wherein the socket is a guide and advancement structure and the closure member is a locking cap.

11. The rod-to-rod connector implant of claim 10 , wherein the guide and advancement structure is a spirally wound flange feature.

12. The rod-to-rod connector implant of claim 1 , wherein the connector body, the locking member, the connecting member, and the closure member each comprise titanium.

13. 1. A system comprising: A first rod; A second rod; and a rod-to-rod connector implant connecting the first rod to the second rod, the rod-to-rod connector implant comprising: A connector body, a first rod channel and a second rod channel, the first rod channel opening on an opposite side of the connector body from the second rod channel, the first rod channel being offset outwardly from the second rod channel; a recess extending through the connector body between the first rod channel and the second rod channel. A connector body, a locking member movably coupled to the connector body, the locking member positioned at least partially within the recess and extending into the first rod channel and the second rod channel; a closure member for engaging a socket in the second rod channel; In a locked position, the closure member functions as a single locking mechanism to retain the first rod in the first rod channel and the second rod in the second rod channel. system.

14. 14. The system of claim 13, wherein the first rod is an index rod and the second rod is an extension rod.

15. 14. The system of claim 13, wherein the first rod is a first extension rod and the second rod is a second extension rod.

16. The system of claim 13 , wherein the first rod and the second rod each have a circular cross-section and an outer diameter of about 3.5 mm to about 4.0 mm.

17. 1. A method of inserting a rod-to-rod connector implant, comprising: A rod-to-rod connector implant is provided, comprising: The rod-to-rod connector implant comprises: a connector body having a first rod channel and a second rod channel, the first rod channel opening on an opposite side of the connector body from the second rod channel, the first rod channel being offset outwardly from the second rod channel; a recess extending through the connector body between the first rod channel and the second rod channel; a locking member movably coupled to the connector body, the locking member positioned at least partially within the recess and extending into the first rod channel and the second rod channel; a closure member for engaging a socket in the second rod channel. To provide and inserting, using forceps, the connector body over the first rod such that the first rod is disposed within the first rod channel, the first rod being fixed in place within a patient; inserting the second rod into the second rod channel from the opposite side of the connector body; actuating movement of the locking member at least partially out of the second rod channel to contact the second rod with a second rod contact surface of the locking member such that the first rod locking surface extends into the first rod channel, thereby retaining the first rod within the first rod channel; and inserting a closure member into the socket to lock the rod-to-rod connector implant onto the first rod and the second rod with a single locking mechanism. method.

18. 20. The method of claim 17, wherein the first rod is an index rod and the second rod is an extension rod.

19. 18. The method of claim 17, wherein the first rod is a first extension rod and the second rod is a second extension rod.

20. inserting the connector body downwardly onto the first rod, the first rod channel opening to a bottom surface of the connector body; inserting the second rod downwardly into the second rod channel, the second rod channel opening to a top surface of the connector body; and inserting the closure member downwardly into the socket, the socket being disposed at the opening of the second rod channel in the top surface of the connector body.

20. The method of claim 17.

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