Percutaneous posterior fixation
Tulip rod connectors with a single locking screw mechanism and percutaneous crossbar insertion address the invasiveness and complexity of conventional spinal fixation, enabling efficient, minimally invasive procedures with reduced surgical time and risk.
Patent Information
- Application Number
- JP2024034570
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2024-02-22
- Filing Date
- 2024-03-07
- Publication Date
- 2025-12-04
- Estimated Expiration
- 2044-03-07
AI Technical Summary
Conventional percutaneous posterior spinal fixation techniques are overly invasive and complicated, posing challenges in minimally invasive procedures.
The use of tulip rod connectors with a spinal rod slot and crossbar slot, allowing for a single locking screw action to secure both the spinal rod and crossbar, and a crossbar designed for percutaneous insertion across the spinal midline through incisions on either side, facilitating minimally invasive spinal fixation.
Enables efficient, minimally invasive spinal fixation procedures with reduced surgical time and risk, allowing for on-site assembly and adaptation to various anatomical sizes and alignments.
Smart Images

Figure 0007780562000001 
Figure 0007780562000002 
Figure 0007780562000003
Abstract
Description
[Technical Field]
[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is a non-provisional application and claims priority to Provisional Application No. 63 / 450,710, filed March 8, 2023, which is incorporated herein by reference in its entirety for all purposes.
[0002] FIELD OF THE INVENTION The present disclosure relates generally to medical devices, and more particularly to the field of spinal surgery and spinal fixation devices. [Background technology]
[0003] Percutaneous posterior spinal fixation procedures can provide significant health benefits and / or relief to patients suffering from various spinal deformities. However, certain conventional techniques are overly invasive and / or complicated. Summary of the Invention
[0004] These and other needs are addressed by the embodiments of spinal rod connectors (also called tulip rod connectors), devices, spinal fixation systems, and related methods described in this disclosure. All examples and features described below may be combined in any technically possible manner.
[0005] A particular implementation includes a tulip rod connector for a spinal structure, the tulip rod connector including a spinal rod slot having a first engagement direction, a crossbar slot having a second engagement direction different from the first engagement direction, and a locking screw slot adjacent to the crossbar slot, wherein the tulip rod connector allows for locking of both the spinal rod in the spinal rod slot and the crossbar in the crossbar slot with a single locking screw action.
[0006] In certain aspects, a method of percutaneous posterior fixation to a patient involves inserting and connecting a crossbar across the patient's spinal midline through incisions on either side of the spinal midline.
[0007] An additional specific aspect includes a crossbar for a percutaneous posterior fixation procedure, the crossbar being sized to span across a patient's spinal midline, the crossbar having a body having a fixation section and a loading section removably coupled to the fixation section, the loading section being removable after the fixation sections engage a pair of tulip rod connectors on either side of the patient's spinal midline.
[0008] Implementations may include one of the following features or any combination thereof.
[0009] In certain embodiments, the crossbar slot is oversized relative to the crossbar to allow for at least one of off-axis positioning of the crossbar or engagement with multiple different crossbars having different overall dimensions.
[0010] In certain embodiments, the spinal rod slot allows for a pressure-fit connection between the tulip rod connector and the spinal rod.
[0011] In some variations, the spinal rod slot is defined by a set of snap-fit members.
[0012] In certain cases, the crossbar slot is exposed at the top of the tulip rod connector.
[0013] In certain aspects, the tulip rod connector further includes a locking flange for engaging the crossbar within the crossbar slot.
[0014] In some implementations, the crossbar slot is closed at the top of the tulip rod connector.
[0015] In certain cases, the tulip rod connector further includes a compliant flex zone adjacent the spinal rod slot and the crossbar slot.
[0016] In some aspects, the compliant flex zone converts at least a portion of the downward force from a single locking screw action in the locking screw slot into a clamping force on the rod slot.
[0017] In some implementations, the compliant bending zone is defined by at least one of an opening or a thinned section.
[0018] In certain embodiments, the second engagement direction is approximately perpendicular to the first engagement direction.
[0019] In certain cases, the body of the tulip rod connector is a monolithic piece of material, which may include a single piece of metal or composite material.
[0020] In some implementations, the body of the tulip rod connector includes multiple distinct components, including a body and a collet that at least partially defines a spinal rod slot.
[0021] In certain embodiments, the width of the spinal rod slot is greater than the width of the crossbar slot.
[0022] In certain cases, the crossbar slots are non-circular.
[0023] In some implementations, the crossbar slot has a rounded rectangular cross-sectional shape in a direction perpendicular to the second engagement direction.
[0024] In certain cases, inserting and connecting the crossbars is performed without any incision (eg, an external incision) through the patient's spinal midline.
[0025] In certain embodiments, inserting and connecting the crossbars is performed through only two incisions, one on each side of the spinal midline.
[0026] In certain implementations, the crossbars are inserted and connected via lateral subcutaneous insertion across the spinal midline.
[0027] In some cases, the method further includes coupling a first tulip rod connector to a first spinal rod on a first side of the patient's spinal midline, coupling a second tulip rod connector to a second spinal rod on a second side of the patient's spinal midline, inserting a crossbar into a first crossbar slot of the first tulip rod connector, inserting the crossbar into a second crossbar slot of the second tulip rod connector, securing the crossbar to the first tulip rod connector with a first locking screw, and securing the crossbar to the second tulip rod connector with a second locking screw.
[0028] In some embodiments, the method further includes coupling a first tulip rod connector to a first spinal rod on a first side of the patient's spinal midline, the first tulip rod connector including a first crossbar slot; inserting a crossbar into a second crossbar slot of a second tulip rod connector on a second side of the patient's spinal midline; coupling the second tulip rod connector to a second spinal rod on the second side of the patient's spinal midline; inserting the crossbar into the first crossbar slot of the first tulip rod connector; securing the crossbar to the first tulip rod connector with a first locking screw; and securing the crossbar to the second tulip rod connector with a second locking screw.
[0029] In certain cases, the method further includes coupling a first tulip rod connector to a first spinal rod on a first side of the patient's spinal midline, coupling a crossbar to a first crossbar slot of the first tulip rod connector, and securing the crossbar to the first tulip rod connector with a first locking screw, coupling a second tulip rod connector to a second spinal rod on a second side of the patient's spinal midline, coupling the crossbar to a second crossbar slot of the second tulip connector, and securing the crossbar to the second tulip rod connector with a second locking screw.
[0030] In certain implementations, securing the crossbar to the first tulip rod connector occurs before coupling the second tulip rod connector to a second spinal rod on a second side of the spinal midline.
[0031] In some aspects, coupling the first tulip rod connector to the first spinal rod and coupling the crossbar of the first crossbar slot is performed by a reducer tool.
[0032] In certain cases, the reducer tool is configured to engage the first tulip rod connector and the crossbar in a direction perpendicular to the direction of the first spinal rod.
[0033] In certain embodiments, the reducer tool is configured to pass the crossbar from a first side of the spinal midline to a second side of the spinal midline. In some embodiments, the reducer tool includes a reducer tower.
[0034] In some cases, the method is performed using a first tulip rod connector on a first side of the spinal midline and a second tulip rod connector on a second side of the spinal midline.
[0035] In certain embodiments, the spinal rod slot in each tulip rod connector allows for a pressure-fit connection between the respective tulip rod connector and the spinal rod during the insertion and connection process.
[0036] In some cases, the method can be used in the initial spinal construction procedure.
[0037] In certain cases, the method can be used in spinal revision surgery.
[0038] In certain aspects, the crossbar has a fixation section with a longitudinal axis aligned with an insertion direction that transverses the patient's spinal midline.
[0039] In some cases, the crossbar includes a breakaway zone between the fixed section and the loading section to allow removal of the loading section.
[0040] In a particular embodiment, the stationary section has a cylindrical cross-sectional shape.
[0041] In certain aspects, the anchoring section has a non-cylindrical cross-sectional shape, including at least one of an oval, a rounded rectangle, or a tapered rectangle.
[0042] In some cases, the fixation sections are sized to fit into the crossbar slots of each of the tulip rod connectors with a clearance that allows for coupling between tulip rod connectors that are misaligned in at least one of the X, Y, or Z directions.
[0043] In certain embodiments, the tip of the fixation section is tapered or pointed.
[0044] In some embodiments, the stationary section is bendable and rotatable.
[0045] In certain embodiments, the fixation section includes a section having a reduced cross-sectional dimension (eg, a flexion zone) to assist in at least one of flexion or rotation.
[0046] Two or more features described in this disclosure, including those described in this Summary section, may be combined to form an implementation not specifically described herein.
[0047] The foregoing presents a simplified summary in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview. It is not intended to identify key or critical elements of the invention or to delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented below.
[0048] The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]
[0049] [Figure 1] 1A-1D illustrate front views of a tulip rod connector according to various implementations. [Figure 2] FIG. 2 shows a side view of the tulip rod connector of FIG. 1. [Figure 3] 3 shows a perspective view of the tulip rod connector of FIGS. 1 and 2. FIG. [Figure 4] 4 shows a partial cross-sectional view of the tulip rod connector of FIGS. 1-3 with a crossbar, spinal rod, and reducer tool. [Figure 5] 10A-10C illustrate front views of tulip rod connectors according to various additional implementations. [Figure 6] FIG. 6 shows a side view of the tulip rod connector of FIG. [Figure 7]7 shows a perspective view of the tulip rod connector of FIGS. 5 and 6. FIG. [Figure 8] 8 shows a partial cross-sectional view of the tulip rod connector of FIGS. 5-7 with a crossbar, spinal rod, and reducer tool. FIG. [Figure 9] 10A-10C illustrate side, top, perspective, and cutaway views of a tulip rod connector according to various additional implementations. [Figure 10] 10A-10C illustrate side, top, perspective, and cutaway views of a tulip rod connector according to various additional implementations. [Figure 11] 10A-10C illustrate side, top, perspective, and cutaway views of a tulip rod connector according to various additional implementations. [Figure 12] 10A-10C illustrate side, top, perspective, and cutaway views of a tulip rod connector according to various additional implementations. [Figure 13] 10A-10C illustrate side, top, perspective, and cutaway views of a tulip rod connector according to various additional implementations. [Figure 14] 1A-1D illustrate perspective, side, top, and end views of a crossbar according to various implementations. [Figure 15] 1A-1D illustrate perspective, side, top, and end views of a crossbar according to various implementations. [Figure 16] 1A-1D illustrate perspective, side, top, and end views of a crossbar according to various implementations. [Figure 17] 1A-1D illustrate perspective, side, top, and end views of a crossbar according to various implementations. [Figure 18] 1A-1C are perspective views of a system for assembling a spinal fixation construct, including depictions of a portion of a patient's spinal midline, according to various implementations. [Figure 19] 1A-1C are close-up perspective views of a partially completed spinal fixation construct spanning the spinal midline of a patient, according to various implementations. [Figure 20] 1 is a flow diagram illustrating processes in a method, according to various implementations. [Figure 21] 10A-10C are flow diagrams illustrating processes in methods according to various additional implementations. [Figure 22] 1 is a flow diagram illustrating processes in a method, according to various implementations.
[0050] It should be noted that the drawings of the various implementations are not necessarily to scale. The drawings are intended to depict only typical aspects of the present disclosure and therefore should not be considered limiting of the scope of the implementations. In the drawings, like numbers represent like elements between the drawings. DETAILED DESCRIPTION OF THE INVENTION
[0051] Various implementations include spinal fixation components and related methods. Particular implementations include systems, devices, and methods for a modular percutaneous posterior stabilization system. One system embodiment utilizes a tulip-head connector implant that provides connection and / or extension from one rod to another through a joint crossbar and locking screw locking mechanism. One approach utilizes a minimally invasive percutaneous approach to posterior spinal surgery, including percutaneous delivery of implant components using a combination of an extension tube tower instrument and a rod inserter for in-situ implant assembly.
[0052] For clarity, not all features of an actual implementation are described herein. It will, of course, be recognized that the development of any such actual embodiment will require numerous implementation-specific decisions to achieve the developer's specific objectives, including compliance with system- and business-related constraints that vary from implementation to implementation. It will further be recognized that such a development effort may be complex and time-consuming, but would nevertheless be routine for those of ordinary skill in the art having the benefit of this disclosure. The devices, related systems, and methods described herein possess various inventive features and components that, both individually and in combination, are grounds for patent protection. It will be understood that any given element of the disclosed embodiments of the invention may be embodied in a single structure, a single step, a single material, etc. Likewise, a given element of the disclosed embodiments may be embodied in multiple structures, steps, materials, etc.
[0053] The present disclosure provides, at least in part, a tulip rod connector for a spinal fixation system. The tulip rod connector can include a spinal rod slot having a first engagement direction, a crossbar slot having a second engagement direction different from the first engagement direction, and a locking screw slot adjacent to the crossbar slot, allowing the tulip rod connector to lock both the spinal rod in the spinal rod slot and the crossbar in the crossbar slot with a single locking screw action. Further implementations include a method of percutaneous posterior fixation to a patient by inserting and connecting a crossbar across the patient's spinal midline through incisions on either side of the spinal midline. Additional implementations include a crossbar for a percutaneous posterior fixation procedure sized to engage the tulip rod connector.
[0054] Various disclosed implementations can enable minimally invasive percutaneous spinal fixation procedures. Certain disclosed implementations enable inserting and connecting a crossbar across a patient's spinal midline through incisions on either side of the midline. Certain disclosed implementations enable inserting and connecting a crossbar across the spinal midline without any incisions (e.g., external incisions) through the patient's spinal midline. Other disclosed implementations enable inserting and connecting a crossbar through only two incisions, one on each side of the spinal midline. Further disclosed implementations enable inserting and connecting a crossbar through a lateral subcutaneous insertion across the spinal midline.
[0055] Commonly labeled components in the figures are considered to be substantially equivalent components for purposes of illustration, and redundant discussion of those components is omitted for clarity.
[0056] FIGS. 1-3 illustrate a tulip rod connector 10 (also referred to as a "connector") for use in a spinal fixation procedure. FIGS. 1, 2, and 3 illustrate front, side, and perspective views of the connector 10, respectively. FIG. 4 illustrates the connector 10 interacting with a spinal rod 20, a crossbar 30, and a locking screw 40. As further described herein with respect to FIG. 4, the tulip rod connector 10 is configured to couple with the spinal rod 20 and the crossbar 30 as part of a spinal fixation construct. As is known in the art, the spinal rod 20 generally extends along the patient's spine, for example, along one side of the patient's spinal midline. FIGS. 18 and 19 illustrate an apparatus 500 for performing a spinal fixation procedure using the tulip rod connector 10, showing the patient's spinal midline 50 and the crossbar 30 spanning across the spinal midline 50 between two connectors 10.
[0057] 1 to 3, the connector 10 is engaged in a first engagement direction (D e1 ) and a spinal rod slot 60 having a second, different engagement direction (D e2) and a crossbar slot 70 having a D e1 is D e2 , and is generally perpendicular to the crossbar slot 70. The spinal rod slot 60 is configured to receive the spinal rod 20, and the crossbar slot 70 is configured to receive the crossbar 30 (FIG. 4). In various implementations, the locking screw slot 80 is positioned adjacent to the crossbar slot 70 and is configured to receive the locking screw 40 (FIG. 4). As described herein and at least partially illustrated in FIG. 4, the connector 10 can be configured to allow both the spinal rod 20 in the spinal rod slot 60 and the crossbar 30 in the crossbar slot 70 to be locked with a single locking screw action, for example, by tightening the locking screw 40 to engage complementary threads on the connector 10.
[0058] In various implementations, the spinal rod slot 60 allows for a pressure-fit connection between the connector 10 and the spinal rod ( FIG. 4 ). In certain cases, the spinal rod slot 60 is defined by a set of snap-fit members 90, e.g., two opposing snap-fit members 90A, 90B that can be sized and / or separated to allow flexure to engage or disengage the spinal rod 20. In certain cases, the snap-fit members 90A, 90B include a partially arcuate inner surface 100 configured to complement a portion of the arcuate outer surface of the spinal rod 20. In some cases, each snap-fit member 90A includes a lip 110 configured to retain the spinal rod 20 after it is snapped into the slot 60. In additional implementations, the spinal rod slot 60 can be defined by a set of members, e.g., separate members, at least one of which is rigid or fixed and at least one of which is malleable (e.g., a snap-fit member). In one example, the spinal rod slot 60 is defined by one snap-fit member (eg, snap-fit member 90A) and an opposing rigid (or fixed) member.
[0059] In some cases, the crossbar slots 70 are oversized relative to the crossbar 30 to allow for off-axis positioning of the crossbar 30 and / or to allow for engagement with multiple different crossbars having different overall dimensions. That is, the crossbar slots 70 are (D e2 ) than the outer dimension of the crossbar 30. In such a case, the crossbar slot 70 may tilt the crossbar 30 by, for example, up to 5 degrees, 10 degrees, or 15 degrees in the second engagement direction (D e2 ) to allow positioning at angles that deviate from the crossbar slot 70. Additionally, in some embodiments, the crossbar slot 70 is sized to receive crossbars of various sizes (e.g., overall dimensions or widths), allowing the connector 10 to be adapted for spinal fixation procedures in patients with different anatomical sizes. In certain cases, the width (w) of the crossbar slot 70 may be adjusted to accommodate various crossbar sizes. cbs ) is the width (w srs ) is narrower than
[0060] In certain aspects, the connector 10 further includes a compliant flex zone 120 adjacent the spinal rod slot 60 and the crossbar slot 70. The compliant flex zone 120 can be defined (thinned relative to adjacent sections) by an opening 130 and / or a thinned section 140 (e.g., a notch in a sidewall) of the connector 10. In various implementations, for example, as illustrated in FIG. 4 , the compliant flex zone 120 converts at least a portion of the downward force into a clamping force on the spinal rod slot 60 by a single locking screw action in the locking screw slot 80. That is, the compliant flex zone 120 allows both the spinal rod 20 and the crossbar 30 to be locked by actuation of the locking screw 40 in the locking screw slot 80. FIG. 4 helps illustrate this feature of the connector 10. When the locking screw 40 is tightened into the locking screw slot 80 (e.g., via thread interaction), the locking screw 40 applies a downward force to the crossbar 30 positioned in the crossbar slot 70. Because the compliant flex zone 120 is located between the crossbar slot 70 and the spinal rod slot 60, when the crossbar 30 is pressed downward, the crossbar 30 applies a force to the snap-fit members 90A, 90B, clamping the spinal rod 20 inwardly within the spinal rod slot 60. In various implementations, the openings 130 and / or thinned sections 140 allow for greater flexion of the compliant flex zone 120 than other sections of the connector 10. Thus, when a force is applied by the action of the locking screw, the compliant flex zone 120 flexes (or bends), converting the downward force from the locking screw 40 into a clamping force on the spinal rod slot 60.
[0061] In certain implementations, such as the implementation illustrated in FIGS. 1-4, the crossbar slot 70 is exposed at the top 150 of the connector 10. In such cases, the crossbar slot 70 is defined by distinct, opposite walls (or wings) 160 that are not connected at the top 150 of the connector 10. The walls 160A, 160B may include internal threads that define the locking screw slot 80 (above the crossbar slot 70). In these cases, the crossbar 30 may be threaded in the second engagement direction (D e2 ) can be loaded into the crossbar slot 70 from the top 150 of the connector 10 (e.g., through the locking screw slot 80). In some of these implementations, the connector 10 can include at least one locking flange 170 in the locking screw slot 80 for engaging the crossbar 30 within the crossbar slot 70. In various implementations, the threads of the locking screw slot 80 include the locking flange 170, e.g., helical flange threads, that help prevent the walls 160 from spreading apart and the crossbar slot 70 from correspondingly bending. That is, the locking flange 170 can prevent the locking screw threads 172 from engaging the locking screw 40 ( FIG. 4 ) and causing the walls 160 to spread (or tilt radially) relative to the locking screw 40. In certain cases, the locking flange 170 and the locking screw threads 172 include complementary ridges or hooks configured to provide resistance across two surfaces, such as, for example, complementary multi-sided ridges. The interaction between the locking flange 170 and the locking screw threads 172 can help maintain the radial position of the wall 160 (relative to the axial movement of the locking screw) in an open (or exposed) crossbar slot configuration, as illustrated in Figures 1-4 and 9-13.
[0062] In additional implementations, such as the exemplary connector 10A illustrated in FIGS. 5-8, the crossbar slot 70 is closed at the top 150 of the connector 10A. In these cases, the annular member 180 can define the locking screw slot 80 such that the crossbar 30 can only be loaded into or out of the slot 80 through one of the slot openings 190. In certain embodiments, the crossbar slot 70 is non-circular. For example, as particularly clearly illustrated in FIGS. 5 and 7, the crossbar slot 70 can be configured to be oriented in a second engagement direction (D e2 ) may have a rounded rectangular cross-sectional shape. In some cases, the crossbar slots 70 are shaped to accommodate crossbars 30 having a non-circular cross-sectional shape, such as a rounded rectangular or elongated cross-sectional shape. Specific examples of such crossbars 30 are illustrated in Figures 14-17.
[0063] In some implementations, the body of connector 10 (and / or 10A) is a monolithic piece of material. In such embodiments, the body of connector 10 can include a single piece of metal or composite material. In other cases, connector 10 (and / or 10A) has a body that includes multiple distinct components. In one embodiment, as illustrated in FIGS. 9-13, connector 10B includes multiple distinct components. For example, as described with respect to connector 10A, connector 10B can include a body 200 that defines spinal rod slot 60, crossbar slot 70, and locking screw slot 80. In these implementations, spinal rod slot 60 is further defined by an insert 210 configured to mate with snap-fit members 90A, 90B. Insert 210 can include a collet, such as a spherical collet. In certain implementations, the insert 210 extends from a lower portion of the crossbar slot 70 into the spinal rod slot 60 so that the crossbar 30 contacts the insert 210 when the connector 10B is locked, e.g., so that the crossbar 30 applies a locking force to the insert 210. In other implementations, the insert 210 is located entirely below the crossbar slot 70 (between the snap-fit members 90A, 90B) so that the crossbar 30 does not contact the insert 210 when inserted. In these cases, the insert 210 is held within the spinal rod slot 60 by the clamping force of the snap-fit members 90A, 90B. In various implementations, the insert 210 includes an arc-shaped member having a spherical outer surface 220 configured to pivot and rotate within the snap-fit members 90A, 90B. The insert 210 can be configured to allow one or more degrees of freedom to accommodate different spinal rod angles, e.g., when the connector 10B is unlocked. In various implementations, the insert 210 may be oriented in a first engagement direction (D e1 ) into the second engagement direction (D e2) allows connector 10B to be positioned off-axis relative to spinal rod 20. In some cases, snap-fit members 90A, 90B can include at least one flat surface (or flat section) 230 configured to interact with spherical outer surface 220 of insert 210 to limit movement of insert 210. In certain cases, insert 210 further includes at least one flat surface (or flat section 232) configured to limit movement of insert 210 relative to snap-fit members 90A, 90B. In various implementations, insert 210 includes at least one lip 240 on arm 250 configured to retain spinal rod 20, for example, in a snap-fit connection. Similar to connectors 10 and 10A, connector 10B can be configured to allow simultaneous locking of both spinal rod 20 in spinal rod slot 60 (e.g., in insert 210) and crossbar 30 in crossbar slot 70 with a single locking screw action.
[0064] 14-17 illustrate views of a crossbar 30 according to certain implementations. In these embodiments, the crossbar 30 is sized to span across a patient's spinal midline 50 (FIGS. 18 and 19) and includes a body 260 having a fixation section 270 and a loading section 280 removably coupled to the fixation section 270. In certain cases, the loading section 280 is removable after the fixation section engages a pair of tulip rod connectors 10 (10A, 10B) on either side of the spinal midline 50. In other cases, the loading section 280 remains with the fixation section 270 after the crossbar 30 is secured to the connectors 10. In various implementations, the crossbar 30 is one of a pair (e.g., two or more) crossbars that span between different spinal rods 20 positioned on either side of the spinal midline 50. In some cases, the body 260 may include a breakaway zone 290 between the securing section 270 and the loading section 280 to allow for removal (e.g., snap-off removal or twist-off removal) of the loading section 280.
[0065] As illustrated in FIGS. 14-17, the fixation section 270 is oriented in an insertion direction transverse to the spinal midline 50 (e.g., a first engagement direction D e1 ) and the longitudinal axis (A lf ) In some cases, the anchoring section 270 may have a cylindrical cross-sectional shape. In other cases, the anchoring section 270 has a non-cylindrical cross-sectional shape 300, for example, as illustrated in FIGS. 14-17. In some embodiments, the non-cylindrical cross-sectional shape 300 includes at least one of an oval, a rounded rectangle, or a tapered rectangle. In some cases, the anchoring section 270 is sized to fit into the crossbar slot 70 of each of the tulip rod connectors 10 (or 10A, 10B) with clearance that allows for coupling between tulip rod connectors 10 that are misaligned in at least one of the X, Y, or Z directions. That is, the outer dimensions of the anchoring section 270 can be undersized relative to the inner dimensions of the crossbar slot 70 to allow for alignment adjustment of the crossbar 30 when positioned within the slot 70. In certain embodiments, the tip 310 of the anchoring section 270 is tapered or pointed.
[0066] In further embodiments, the stationary section 270 is bendable and / or rotatable. In certain embodiments, the stationary section 270 includes a section 320 (also referred to as a "flexion zone") having a reduced cross-sectional dimension to aid in at least one of bending or rotation. The stationary section 270 can also be configured to bend and rotate in situ (e.g., at section 320). According to certain implementations, the loading section 280 includes a recess 330 for engaging a reducer tool 332 (FIG. 18). In certain cases, the recess 330 is aligned with the longitudinal axis (A lf ) perpendicular to the principal axis (A pr ) (FIG. 16). In certain embodiments, the exterior dimensions of the loading section 280 arepr ) is larger than the outer dimensions of the fixed section 270.
[0067] Various implementations include devices, systems, and related procedures for percutaneous posterior fixation to a patient. For example, the procedure seen in FIGS. 18 and 19 can include inserting and connecting a crossbar (e.g., crossbar 30) across the spinal midline 50 through incisions on both sides of the spinal midline 50. In some cases, the procedure includes connecting the crossbar 30 to a first tulip rod connector 10 on a first side of the spinal midline 50 and a second tulip rod connector 10 on a second side of the spinal midline 50. In certain embodiments, inserting and connecting the crossbar 30 is performed without any incisions (e.g., external incisions) through the patient's spinal midline 50. In further certain cases, inserting and connecting the crossbar 30 is performed through only two incisions, one on each side of the patient's spinal midline 50. In some of these cases, inserting and connecting the crossbar 30 is performed through a lateral subcutaneous insertion across the spinal midline 50. As described herein, the cross bar 30 and corresponding spinal rod 20 can be secured within the connector 10 with a single locking screw action, such as by tightening the locking screws 40 to fully engage the threads of the locking screw slots 80. The connector 10 allows for numerous variations on the approach for percutaneous posterior fixation to a patient, certain examples of which are described herein. With reference to FIGS. 18 and 19 , in certain implementations, a reducer tool 332 (e.g., a reducer tower) can be used to couple the connector 10 to the spinal rod 20. In various implementations, a rod inserter 334 can be used to insert the cross bar 30 across the spinal midline 50, for example, to connect with tulip rod connectors 10 on either side of the midline 50. In additional implementations, or in a complementary scenario, a pile driver reducer 336 can be used to assist in securing the locking screws 40 within the locking screw slots 80, for example, to secure the cross bar 30 and spinal rod 20 within the connector 10. In an additional optional implementation, forceps can be used to assist in guiding the crossbar 30 through the patient's spinous processes and / or internal spinous ligaments.
[0068] 20-22 are flow diagrams illustrating processes in a method for percutaneous posterior fixation.
[0069] 20 is a flow diagram illustrating a process in a method of percutaneous posterior fixation in a patient, according to some implementations. With continued reference to FIGS. 18 and 19, the method includes: P1: A process of coupling a first tulip rod connector 10 to a first spinal rod 20 on a first side of the patient's spinal midline 50; P2: The process of coupling a second tulip rod connector 10 to a second spinal rod 20 on a second side of the patient's spinal midline 50; P3: Inserting the crossbar 30 into the first crossbar slot 70 of the first tulip rod connector 10; P4: Inserting the crossbar 30 into the second crossbar slot 70 of the second tulip rod connector 10; P5: A process of fixing the crossbar 30 to the first tulip rod connector 10 by the first locking screw 40; P6: A process of fixing the crossbar 30 to the second tulip rod connector 10 by the second lock screw 40.
[0070] 21 is a flow diagram illustrating a process in a method of percutaneous posterior fixation in a patient, according to some implementations. With continued reference to FIGS. 18 and 19, the method includes: P101: A process of coupling a first tulip rod connector 10 to a first spinal rod 20 on a first side of a patient's spinal midline 50, the first tulip rod connector 10 including a first crossbar slot 70; P102: The process of inserting a crossbar 30 into a second crossbar slot 70 of a second tulip rod connector 10 on a second side of the patient's spinal midline 50; P103: The process of coupling a second tulip rod connector 10 to a second spinal rod 20 on a second side of the patient's spinal midline 50; P104: A process of inserting the crossbar 30 into the first crossbar slot 70 of the first tulip rod connector 10; P105: A process of securing the crossbar 30 to the first tulip rod connector 10 by a first locking screw 40; P106: The process of securing the crossbar 30 to the second tulip rod connector 10 by the second locking screw 40.
[0071] 22 is a flow diagram illustrating a process in a method of percutaneous posterior fixation in a patient, according to some implementations. With continued reference to FIGS. 18 and 19, the method includes: P201: A process of coupling a first tulip rod connector 10 to a first spinal rod 20 on a first side of a patient's spinal midline 50; P202: A process of coupling a crossbar 30 in a first crossbar slot 70 of a first tulip rod connector 10; P203: A process of securing the crossbar 30 to the first tulip rod connector 10 by a first locking screw 40; P204: The process of coupling a second tulip rod connector 10 to a second spinal rod 20 on a second side of the patient's spinal midline 50; P205: A process of coupling the crossbar 30 to the second crossbar slot 70 of the second tulip rod connector 10; P206: The process of securing the crossbar 30 to the second tulip rod connector 10 by the second locking screw 40.
[0072] In some of these embodiments, securing the crossbar 30 to the first tulip rod connector 10 occurs before coupling the second tulip rod connector 10 to the second spinal rod 20 on the second side of the spinal midline 50. In various implementations, coupling the first tulip rod connector 10 to the first spinal rod 20 and coupling the crossbar 30 in the first crossbar slot 70 is performed by a reducer tool 332, such as a reducer tower ( FIG. 18 ). The reducer tool 332 can be configured to engage the first tulip rod connector 10 and the crossbar 30 in a direction perpendicular to the direction of the first spinal rod 20. In certain embodiments, another reducer tool (e.g., a rod inserter 334) is configured to pass the crossbar 30 from the first side of the spinal midline 50 to the second side of the spinal midline 50.
[0073] As described herein, minimally invasive percutaneous posterior fixation procedures have traditionally presented challenges to medical professionals. For example, placing a crossbar or cross-connector between spinal rod connectors (e.g., across the spinal midline) in a minimally invasive manner can be difficult. Navigating the crossbar through soft tissue and spinal structures can be challenging, especially with the limited visibility available in percutaneous procedures. Thus, many conventional techniques use one or more incisions across the patient's midline to improve visualization of the soft tissue and spinal structures. Certain of these challenges are described in U.S. Pat. No. 9,610,104 (the '104 patent), which is incorporated herein by reference in its entirety. In contrast to the revision system and expander structures described in the '104 patent, the various disclosed implementations can be beneficially deployed during the initial construction procedure (as well as revision procedures). Furthermore, the disclosed implementations enable fixation of the spinal rods and crossbar with a single locking screw action, significantly improving the efficiency of cross-midline connections. As described herein, various disclosed implementations can enable minimally invasive percutaneous spinal fusion procedures. In addition to enabling minimally invasive percutaneous spinal fusion procedures, the disclosed implementations can enable on-site assembly of fusion structures, improving the efficiency of the procedure and, consequently, reducing surgical time and associated risks.
[0074] In various implementations, components described as being "coupled" to one another can be joined along one or more interfaces. In some implementations, these interfaces can include joints between different components, while in other cases, these interfaces can include solidly and / or integrally formed interconnects. That is, in some cases, components "coupled" to one another can be formed simultaneously to define a single, continuous member. However, in other implementations, these coupled components can be formed as separate members and then joined through known processes (e.g., soldering, fastening, ultrasonic welding, adhesive bonding). In various implementations, electronic components described as being "coupled" to one another can be coupled via conventional wired and / or wireless means such that the electronic components can communicate data with one another. Additionally, subcomponents within a given component can be considered to be coupled via conventional paths that may not necessarily be illustrated.
[0075] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Any reference to "or" herein is intended to encompass "and / or" unless expressly stated otherwise. As used in this specification and claims, unless expressly stated otherwise, the terms "about," "approximately," "generally," and "substantially" refer to variations of up to ±1%, ±2%, ±3%, ±4%, ±5%, ±6%, ±7%, ±8%, ±9%, ±10%, ±11%, ±12%, ±14%, ±15%, ±16%, ±17%, ±18%, ±19%, or ±20%, depending on the embodiment. As a further non-limiting example, approximately 100 millimeters may represent a range of 95 millimeters to 105 millimeters, 90 millimeters to 110 millimeters, or 85 millimeters to 115 millimeters, depending on the embodiment.
[0076] While the inventive features described herein have been described in terms of preferred embodiments for achieving the objectives, those skilled in the art will recognize that variations can be made in light of these teachings without departing from the spirit or scope of the invention. Also, while the present invention has been described according to its preferred use in spinal applications, it will be recognized that it may be applied to a variety of other applications where surgical fixation, for example, fixation of long bones, is desired.
[0077] Although several implementations have been described, it will nevertheless be understood that additional modifications may be made without departing from the scope of the inventive concepts described herein, and therefore, other implementations are within the scope of the following claims.
Claims
1. 1. A tulip rod connector, comprising: a spinal rod slot extending in a first engagement direction; a crossbar slot extending in a second engagement direction different from the first engagement direction; a lock screw slot adjacent to the crossbar slot; the tulip rod connector allows for locking of both the spinal rod in the spinal rod slot and the cross bar in the cross bar slot by a single locking screw action of tightening a locking screw to engage a locking flange of the locking screw slot; the first engagement direction is a direction in which the spinal rod is inserted into the spinal rod slot, and the second engagement direction is generally perpendicular to the first engagement direction and is a direction in which the cross bar is inserted into the cross bar slot; the locking screw slot extends from one end of the tulip rod connector toward the crossbar slot perpendicular to the first and second engagement directions, and the crossbar slot is located between the locking screw slot and the spinal rod slot; the locking screw slot, the crossbar slot, and the spinal rod slot each have at least one open portion on their outer periphery when viewed in the direction of extension of the respective slots; the crossbar slot is open toward the top of the tulip rod connector at the open portion; the locking flange includes a raised portion extending from an inner end of the locking flange in a direction perpendicular to the first engagement direction and the second engagement direction; the locking screw includes a complementary ridge extending from an outer end of the threads of the locking screw in a direction opposite to the ridge on the locking flange to complementarily engage the locking flange when the locking screw is inserted into the locking screw slot and tightened; The ridges on the locking flange engage the complementary ridges on the threads of the locking screw to prevent the open portion of the crossbar slot from widening.
2. 2. The tulip rod connector of claim 1, wherein the crossbar slot is oversized relative to the crossbar to allow for at least one of positioning of the crossbar relative to the crossbar slot at a predetermined angle deviating from the second engagement direction in a plane parallel to the first engagement direction and the second engagement direction, or reception of a different crossbar in the crossbar slot having different overall dimensions than the crossbar when measured perpendicular to the second engagement direction.
3. 10. The tulip rod connector of claim 1, wherein the spinal rod slot is defined by a pair of oppositely extending members sized to allow flexion, the members allowing engagement and retention of an outer surface of the spinal rod.
4. 2. The tulip rod connector of claim 1, further comprising a flex zone defined by an opening and a notch located between the spinal rod slot and the locking screw slot and adjacent the crossbar slot in the first engagement direction to allow for flexion.
5. 5. The tulip rod connector of claim 4, wherein the flexion zone converts at least a portion of the downward force of the locking screw against the crossbar due to the locking screw action in the locking screw slot into a clamping force on the spinal rod in the spinal rod slot.
6. The tulip rod connector of claim 1 , wherein the tulip rod connector is a monolithic piece of material.
7. The tulip rod connector of claim 1 , wherein the width of the spinal rod slot is greater than the width of the crossbar slot.
8. The tulip rod connector of claim 1 , wherein said crossbar slot is non-circular.
9. 9. The tulip rod connector of claim 8, wherein said crossbar slot has a rectangular shape with rounded corners when viewed in said second engagement direction.
Citation Information
Patent Citations
Connector for the osteointegrator of the spine
JP2001525213A
Apparatus and methods for spinal implant with variable link mechanism
US20070083201A1
Segmental correction and spondylolisthesis reduction system
WO2021226057A1