Patent Application
20240299065
This disclosure generally relates to medical devices. More particularly, the disclosure relates to the field of spinal surgery and spinal fixation devices.
Percutaneous posterior spinal fixation procedures can provide significant health benefits and/or relief for patients suffering from a variety of spinal malformities. However, certain conventional approaches are unduly invasive and/or complicated.
The needs above, as well as others, are addressed by embodiments of spinal rod connectors (also called tulip rod connectors), apparatuses, spinal fixation systems, and related methods described in this disclosure. All examples and features mentioned below can be combined in any technically possible way.
Certain implementations include a tulip rod connector for a spinal construct, the tulip rod connector including: a spinal rod slot having a first engagement direction; a cross-bar slot having a second engagement direction that is distinct from the first engagement direction; and a lock screw slot adjacent to the cross-bar slot, where the tulip rod connector enables locking of both a spinal rod in the spinal rod slot and a cross-bar in the cross-bar slot with a single lock screw action.
In particular aspects, a method of percutaneous posterior fixation on a patient includes: inserting and connecting a cross-bar across a spinal midline of the patient with incisions on either side of the spinal midline.
Additional particular aspects include a cross-bar for a percutaneous posterior fixation procedure, the cross-bar sized to span across a spinal midline of a patient, the cross-bar having: a body having: a fixation section, and a loading section removably coupled with the fixation section, where the loading section is removable after the fixation section engages a set of tulip rod connectors on opposite sides of the spinal midline of a patient.
Implementations may include one of the following features, or any combination thereof.
In certain examples, the cross-bar slot is oversized relative to the cross-bar to enable at least one of: off-axis positioning of the cross-bar, or engagement with a plurality of distinct cross-bars having distinct outer dimensions.
In particular examples, the spinal rod slot enables a pressure-fit connection between the tulip rod connector and the spinal rod.
In some aspects, the spinal rod slot is defined by a set of snap-fit members.
In certain cases, the cross-bar slot is exposed at a top of the tulip rod connector.
In particular aspects, the tulip rod connector further includes a locking flange for engaging the cross-bar in the cross-bar slot.
In some implementations, the cross-bar slot is closed at a top of the tulip rod connector.
In certain cases, the tulip rod connector further includes a compliant bending zone adjacent to the spinal rod slot and the cross-bar slot.
In some aspects, the compliant bending zone translates at least a portion of a downward force from the single lock screw action at the lock screw slot into a clamping force on the rod slot.
In some implementations, the compliant bending zone is defined by at least one of an aperture or a thinned section.
In certain aspects, the second engagement direction is approximately perpendicular to the first engagement direction.
In particular cases, a body of the tulip rod connector is a monolithic piece of material. The monolithic piece of material can include a unitary piece of metal or composite.
In some implementations, a body of the tulip rod connector includes a plurality of distinct components, including: a main body and a collet at least partially defining the spinal rod slot.
In particular aspects, a width of the spinal rod slot is larger than a width of the cross-bar slot.
In certain cases, the cross-bar slot is non-circular.
In some implementations, the cross-bar slot has a rounded rectangular cross-sectional shape in a direction perpendicular to the second engagement direction.
In particular cases, inserting and connecting the cross-bar is performed without any incision (e.g., external incision) through the spinal midline of the patient.
In certain aspects, inserting and connecting the cross-bar is performed with only two incisions, one on each side of the spinal midline.
In particular implementations, inserting and connecting the cross-bar is performed with a lateral, subcutaneous insertion across the spinal midline.
In some cases, the method further includes: coupling a first tulip rod connector to a first spinal rod on a first side of the spinal midline of the patient, coupling a second tulip rod connector to a second spinal rod on a second side of the spinal midline of the patient, inserting a cross-bar in a first cross-bar slot in the first tulip rod connector, inserting the cross-bar in a second cross-bar slot in the second tulip rod connector, securing the cross-bar with a first lock screw in the first tulip rod connector, and securing the cross-bar with a second lock screw in the second tulip rod connector.
In some aspects, a method further includes coupling a first tulip rod connector to a first spinal rod on a first side of the spinal midline of the patient, the first tulip rod connector including a first cross-bar slot, inserting a cross-bar in a second cross-bar slot in a second tulip rod connector on a second side of the spinal midline of the patient, coupling the second tulip rod connector to a second spinal rod on the second side of the spinal midline of the patient, inserting the cross-bar in the first cross-bar slot in the first tulip rod connector, securing the cross-bar with a first lock screw in the first tulip rod connector, and securing the cross-bar with a second lock screw in the second tulip rod connector.
In particular cases, a method further includes: coupling a first tulip rod connector to a first spinal rod on a first side of the spinal midline of the patient, coupling a cross-bar in a first cross-bar slot in the first tulip rod connector, securing the cross-bar in the first tulip rod connector with a first lock screw, coupling a second tulip rod connector to a second spinal rod on a second side of the spinal midline of the patient, coupling the cross-bar to a second cross-bar slot in the second tulip connector, and securing the cross-bar in the second tulip rod connector with a second lock screw.
In certain implementations, securing the cross-bar in the first tulip rod connector is performed prior to coupling the second tulip rod connector to the second spinal rod on the second side of the spinal midline.
In some aspects, coupling the first tulip rod connector to the first spinal rod and coupling the cross-bar in the first cross-bar slot is performed with a reducer tool.
In particular cases, the reducer tool is configured to engage the first tulip rod connector and the cross-bar in a direction perpendicular to a direction of the first spinal rod.
In certain examples, the reducer tool is configured to pass the cross-bar from the first side of the spinal midline to the second side of the spinal midline. In some examples, the reducer tool includes a reducer tower.
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.
In particular examples, the spinal rod slot of each tulip rod connector enables a pressure-fit connection between the respective tulip rod connector and the spinal rod during the inserting and connecting processes.
In some cases, the method can be used in an initial spinal construction surgery.
In certain cases, the method can be used in a spinal revision surgery.
In particular aspects, the cross-bar has a fixation section with a longitudinal axis aligned with an insertion direction across the spinal midline of the patient.
In some cases, the cross-bar includes a break zone between the fixation section and the loading section for enabling removal of the loading section.
In certain examples, the fixation section has a cylindrical cross-sectional shape.
In particular aspects, the fixation section has a non-cylindrical cross-sectional shape including at least one of an ellipse, a rounded rectangle, or a tapered rectangle.
In some cases, the fixation section is sized to fit in a cross-bar slot in each of the tulip rod connectors with clearance to enable coupling between tulip rod connectors that are misaligned in at least one of an X direction, Y direction, or Z direction.
In particular examples, a tip of the fixation section is tapered or pointed.
In some aspects, the fixation section is both bendable and rotatable.
In certain examples, the fixation section includes a section having a reduced cross-sectional dimension (e.g., bend zone) to aid in at least one of bending or rotating.
Two or more features described in this disclosure, including those described in this summary section, may be combined to form implementations not specifically described herein.
The above 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 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 later.
The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features, objects and benefits will be apparent from the description and drawings, and from the claims.
It is noted that the drawings of the various implementations 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 implementations. In the drawings, like numbering represents like elements between the drawings.
Various implementations include spinal fixation components and related methods. Particular implementations include systems, devices, and methods for a modular, percutaneous posterior fixation system. One embodiment of a system utilizes a tulip head connector implant which provides a connection and/or extension from one rod to another rod through a joining cross-bar and a lock-screw locking mechanism. One approach utilizes a minimally invasive percutaneous approach for posterior spine surgery, including percutaneous delivery of implant components utilizing a combination of extension tube tower instrumentation and rod inserters to assemble the implants in-situ.
In the interest of clarity, not all features of an actual implementation are necessarily described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The devices, related systems, and methods described herein boast a variety of inventive features and components that warrant patent protection, both individually and in combination. It is to be understood that any given elements of the disclosed embodiments of the invention may be embodied in a single structure, a single step, a single substance, or the like. Similarly, a given element of the disclosed embodiment may be embodied in multiple structures, steps, substances, or the like.
This 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 cross-bar slot having a second engagement direction that is distinct from the first engagement direction; and a lock screw slot adjacent to the cross-bar slot, where the tulip rod connector enables locking of both a spinal rod in the spinal rod slot and a cross-bar in the cross-bar slot with a single lock screw action. Further implementations include a method of percutaneous posterior fixation on a patient by inserting and connecting a cross-bar across a spinal midline of the patient with incisions on either side of the spinal midline. Additional implementations include a cross-bar for a percutaneous posterior fixation procedure that is sized to engage the tulip rod connector.
The various disclosed implementations can enable a minimally invasive percutaneous spinal fixation procedure. Certain disclosed implementations enable insertion and connection of a cross-bar across a spinal midline of a patient with incisions on either side of the midline. Particular disclosed implementations enable inserting and connecting the cross-bar across the spinal midline without any incision (e.g., external incision) through the spinal midline of the patient. Other disclosed implementations enable inserting and connecting the cross-bar with only two incisions, one on each side of the spinal midline. Further disclosed implementations enable inserting and connecting the cross-bar with a lateral, subcutaneous insertion across the spinal midline.
Commonly labeled components in the drawings are considered to be substantially equivalent components for the purposes of illustration, and redundant discussion of those components is omitted for clarity.
Returning to
In various implementations, the spinal rod slot 60 enables a pressure-fit connection between the connector 10 and the spinal rod (
In some cases, the cross-bar slot 70 is oversized relative to the cross-bar 30 to enable off-axis positioning of the cross-bar 30 and/or engagement with a plurality of distinct cross-bars having distinct outer dimensions. That is, the cross-bar slot 70 can have an inner dimension that is larger than an outer dimension of the cross-bar 30 (as measured perpendicular to De2). In such cases, the cross-bar slot 70 allows the cross-bar 30 to be positioned at angles that deviate from the second engagement direction (De2), e.g., by up to 5 degrees, 10 degrees, or 15 degrees. Further, in some aspects, the cross-bar slot 70 is sized to receive cross-bars of varying sizes (e.g., outer dimensions, or widths), making the connector 10 adaptable for spinal fixation procedures on patients of differing construct sizes. In certain cases, a width (Webs) of the cross-bar slot 70 is smaller than a width (Wsrs) of the spinal rod slot 60.
In certain aspects, the connector 10 further includes a compliant bending zone 120 that is adjacent to the spinal rod slot 60 and the cross-bar slot 70. The compliant bending zone 120 can be defined by an aperture 130 and/or a thinned section 140 (e.g., a cutout in sidewall(s)) in the connector 10 (thinned relative to neighboring sections). In various implementations, e.g., as illustrated in
In particular implementations, such as in implementations illustrated in
In additional implementations, such as example connector 10A illustrated in
In some implementations, the body of the connector 10 (and/or 10A) is a monolithic piece of material. In such examples, the body of the connector 10 can include a unitary piece of metal or composite. In other cases, the connector 10 (and/or 10A) has a body that includes a plurality of distinct components. In one example, as illustrated in
As illustrated in
In further examples, the fixation section 270 is bendable and/or rotatable. In a particular example, the fixation section 270 includes a section 320 having a reduced cross-sectional dimension (also called a “bend zone”) to aid in at least one of bending or rotating. The fixation 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 (
Various implementations include devices, systems, and related approaches for percutaneous posterior fixation on a patient. For example, viewed in the context of
In some of these examples, securing the cross-bar 30 in the first tulip rod connector 10 is performed prior to 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 cross-bar 30 in the first cross-bar slot 70 is performed with a reducer tool 332, such as a reducer tower (
As noted herein, minimally invasive percutaneous posterior fixation procedures have conventionally presented challenges to medical professionals. For example, it is challenging to place cross-bars or cross-connectors between spinal rod connectors (e.g., across the spinal midline) in a minimally invasive manner. It can be difficult to navigate a cross-bar through soft tissue and the spinal structure, especially with the limited sightlines available in a percutaneous procedure. Accordingly, many conventional approaches use one or more incisions across the patient's midline to improve visualization of the soft tissue and spinal structure. Certain of these challenges are described in U.S. Pat. No. 9,610,104 ('104 patent), which is hereby incorporated by reference in its entirety. In contrast to the revision system and extender construct described in the '104 patent, the various disclosed implementations can be beneficially deployed in an initial construct procedure (as well as in a revision procedure). Further, the disclosed implementations enable securing both a spinal rod and a cross-bar with a single lock screw action, significantly improving the efficiency of the cross-midline connection. As noted herein, the various disclosed implementations can enable a minimally invasive percutaneous spinal fixation procedure. In addition to enabling a minimally invasive percutaneous spinal fixation procedure, the disclosed implementations can enable assembly of a fixation construct in-situ, improving the efficiency of the procedure and consequently reducing surgical time and associated risk.
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 junctions between distinct components, and in other cases, these interfaces can include a solidly and/or integrally formed interconnection. That is, in some cases, components that are “coupled” to one another can be simultaneously formed to define a single continuous member. However, in other implementations, these coupled components can be formed as separate members and be subsequently joined through known processes (e.g., soldering, fastening, ultrasonic welding, bonding). In various implementations, electronic components described as being “coupled” can be linked via conventional hard-wired and/or wireless means such that these electronic components can communicate data with one another. Additionally, sub-components within a given component can be considered to be linked via conventional pathways, which may not necessarily be illustrated.
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 references unless the context clearly dictates otherwise. Any reference to “or” herein is intended to encompass “and/or” unless otherwise stated. As used in this specification and the claims, unless otherwise stated, the term “about,” “approximately,” “generally,” and “substantially” refers to variations of less than or equal 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, about 100 millimeters represents a range of 95 millimeters to 105 millimeters, 90 millimeters to 110 millimeters, or 85 millimeters to 115 millimeters, depending on the embodiments.
While inventive features described herein have been described in terms of preferred embodiments for achieving the objectives, it will be appreciated by those skilled in the art that variations may be accomplished in view of these teachings without deviating from the spirit or scope of the invention. Also, while this invention has been described according to a preferred use in spinal applications, it will be appreciated that it may be applied to various other uses desiring surgical fixation, for example, the fixation of long bones.
A number of implementations have been described. Nevertheless, it will be understood that additional modifications may be made without departing from the scope of the inventive concepts described herein, and, accordingly, other implementations are within the scope of the following claims.
This present application is a non-provisional application and claims priority to provisional application No. 63/450,710 filed on Mar. 8, 2023, which is incorporated by reference herein in its entirety for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63450710 | Mar 2023 | US |
