The present system and method relate generally to modular pedicle screw systems and methods of intra-operatively assembling the same.
Pedicle screw systems are surgically implanted in a number of vertebrae during a spinal operation as an adjunct to fusion. Pedicle screw systems typically include the pedicle screw, a clamp device attached to the pedicle screw, and a rod or other structural member that is received and retained in the clamp device.
Before a spinal operation is scheduled, the surgeon or other trained professional typically performs a non-invasive review of at least a segment of the patient's spinal column. The non-invasive review is typically performed by acquiring an x-ray image, fluoroscopic image, magnetic resonance image (MRI), or other equivalent image of the segment of the patient's spinal column and then the surgeon, a radiologist, or perhaps both review the images. Based on the captured images and likely other factors, the surgeon will determine what type and size of pedicle screw systems will be used during the spinal operation on the patient. Once the type and size of the pedicle screw systems to be used is determined, the surgeon or other staff member will place an order with a manufacturer for the pedicle screw systems.
The manufacturer, once they have received the order, assembles each pedicle screw with the associated clamp device per the specifications identified in the order. It is common practice for the manufacturer to also assemble several “extra” pedicle screw systems comprising sizes that are slightly less and slightly greater than those actually ordered. The requested pedicle screw systems and the extra systems are often manually delivered to the surgery location and made readily available to the surgeon during the spinal operation.
One drawback of the traditional process is that either the surgeon has limited options on what type and even what size of pedicle screw systems to use once the surgery is in progress, i.e., intra-operative; or, the manufacturer is required to provide additional inventory at an exorbitant cost to the manufacturer. Specifically, the traditional state of the art provides that the clamp device and the pedicle screw are pre-assembled, which prevents the surgeon from exchanging or otherwise manipulating the components intra-operatively. For example, after the surgeon gets an intra-operative look at the patient's spinal column after opening the surgical site, the surgeon may decide that a substantially different type or size pedicle screw system is required. This situation may be more acute when the patient is undergoing a follow-up surgery to repair existing hardware, for example.
The pre-operative images typically obtained of the patient only provide a limited amount of information. Only when the surgeon is actively viewing the patient's spinal column can the surgeon have all the necessary information to determine what type and size of pedicle screw systems would be most appropriate for the patient.
Further, a preassembled screw and clamp device is more obtrusive in the surgical wound than just an implanted screw. So, a preassembled screw and clamp device complicate the surgical technique or inhibit certain surgical maneuvers.
According to one exemplary embodiment, the systems, assemblies, devices, and methods described herein provide a variety of ways to intra-operatively select and/or configure a pedicle screw system. The pedicle screw system components described herein may be readily interchangeable and may be made available to the surgeon as a kit, thereby providing the surgeon greater options on structurally fusing, correcting, or otherwise operating on a patient's vertebrae.
Particularly, according to one exemplary embodiment, a modular pedicle screw kit includes a pedicle screw having a threaded, elongated shaft coupled to a head portion; and a plurality of tulip assemblies configured to be installed on the head portion of the pedicle screw, each tulip assembly including a tulip body, a rod receiving portion, and a coupling member configured to releasably couple the tulip body to the pedicle screw after the pedicle screw is inserted in a vertebra.
In yet another exemplary embodiment, a method for intra-operatively assembling a pedicle screw kit includes inserting a pedicle screw into a vertebra, the pedicle screw having a threaded, elongated shaft coupled to a head portion; determining one type of tulip assembly to be installed on the head portion of the pedicle screw after the pedicle screw is inserted in the vertebra, each type of tulip assembly having a tulip body, a rod receiving portion, and a coupling member configured to compressively couple the tulip body to the pedicle screw; and coupling the one type of tulip assembly to the head portion of the pedicle screw.
The foregoing is a summary and thus contains, by necessity, simplifications, generalizations and omissions of detail. Consequently, those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting. Other aspects, inventive features, and advantages of the devices and/or processes described herein, as defined solely by the claims, will become apparent in the non-limiting detailed description set forth herein.
The accompanying drawings illustrate various exemplary embodiments of the present system and method and are a part of the specification. Together with the following description, the drawings demonstrate and explain the principles of the present system and method. The illustrated embodiments are examples of the present system and method and do not limit the scope thereof.
In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn, are not intended to convey any information regarding the actual shape of the particular elements, and have been solely selected for ease of recognition in the drawings. Throughout the drawings, identical reference numbers designate similar but not necessarily identical elements.
The present specification describes a system and a method for providing a modular pedicle screw system. Particularly, according to one exemplary embodiment, the present specification discloses a number of pedicle screws and/or tulip assemblies configured to be combined to create pedicle screw kits that may be advantageously modified and assembled intra-operatively. Further details of the present exemplary system and method will be provided below.
Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present assemblies, devices and systems. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
The headings provided herein are for convenience only and do not interpret or modify the scope or meaning of the claimed invention.
The pedicle screw systems described herein include different types of pedicle screws and/or tulip assemblies that can be combined to create pedicle screw kits that may be advantageously modified and assembled intra-operatively. In addition, according to one exemplary embodiment, the resultant kits are configured to advantageously provide the surgeon with tulip assemblies that can be intra-operatively assembled to a pedicle screw during surgery. For example, according to one exemplary embodiment, a first type of tulip assembly may be desired on a first vertebra while a second type of tulip assembly is desired on an adjacent vertebra. The two different types of tulip assemblies may be combined to achieve a certain type of alignment, to provide a certain degree of strength, or for a variety of other reasons.
Another possible advantage of the present exemplary pedicle screw kits is that a surgeon, once he or she has the surgical site open, may determine that the original type of tulip assemblies selected based on any number of pre-operative images are not the desired type of tulip assemblies. Consequently another type of tulip assembly may be desired. With the present exemplary pedicle screw kit, the surgeon can make this decision even after the pedicle screws have been inserted into a patient's vertebrae and will still have the option of installing a number of different types of tulip assemblies.
In the following description, certain specific details are set forth in order to provide a thorough understanding of various embodiments of the present tools, assemblies, systems, and methods. However, one skilled in the relevant art will recognize that the tools, assemblies, systems, and methods may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures associated with surgical tooling, surgical implant devices, and surgical spinal techniques have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments of the present assemblies, devices and systems.
According to one exemplary embodiment, the present system and method includes a modular pedicle screw kit having a pedicle screw with a threaded elongated shaft coupled to a head portion, and a plurality of tulip assemblies configured to couple the head portion of the pedicle screw, each tulip assembly including a tulip body, a rod receiving portion, and a coupling member configured to releasably couple the tulip body to the pedicle screw after the pedicle screw is inserted in a vertebra. According to this exemplary embodiment, a surgeon may select from the various tulip assemblies intra-operatively without inserting different screws. Various details of the screw and tulip assemblies will be provided in detail below with reference to
Pedicle Screws
According to one exemplary embodiment of the present system and method, pedicle screws are surgically implanted into a patient's vertebrae during a spinal operation. The pedicle screws of the present system and method can take a variety of forms, but each form generally includes a threaded, elongated shaft coupled to a head portion. According to one exemplary embodiment, the threaded, elongated shaft may include, but is in no way limited to, a self-tapping thread. According to the present exemplary system and method, the head portion is sized and shaped to receive various types of tulip assemblies, which are described in detail below.
As illustrated in
While
According to one exemplary embodiment, the split-ball (202) is free to translate along a tapered surface (206) of the head portion (204). The tapered surface (206) of the head portion interfaces with a reciprocal, inner tapered surface (208) of the split-ball (202). The mating or interfacing surfaces (206, 208) have an identical or substantially similar center of curvature, which may advantageously produce a less bulky assembly by decreasing the total height of the combination of the pedicle screw (200) and tulip assembly.
Further,
Pedicle Screw Systems
Referring now to
In one exemplary embodiment, the hoop (408) is pre-operatively assembled with the tulip body (406) and serves to constrain the expansion of the tulip body (406). When the hoop (408) is slid over the flexible top portion of the tulip body (406), the bottom portion of the tulip body (406) is able to expand to receive the head portion of the pedicle screw (402), according to one exemplary embodiment. When the hoop (408) is slid down the tulip body (406), the hoop constrains the bottom portion of the tulip body (406) and thereby captures and retains the head portion of the pedicle screw (402). Once in a desired location, the hoop (408) is rotated to secure the hoop in the down position. At this point, the head portion of the pedicle screw (402) is at least translationally retained in the tulip body (406), but may be free to rotate therein.
Further, according to one exemplary embodiment, the rod saddle (410) is pre-operatively assembled with the tulip body (406) and serves to increase the surface area contact between the rod (not shown) and the pedicle screw (402). During assembly, the rod is inserted into the rod saddle (410) and the cap (412) is then coupled to the tulip body (406) to secure the rod.
When the cap (412) is rotated a quarter turn, a cam feature disposed on the cap expands or spreads the top portion of the tulip body (406) creating a clothes-pin effect, which causes the tulip body (406) to compressively couple the head portion of the pedicle screw (402). This clamping action provisionally fixes the tulip body (406) to the pedicle screw (402) before securing the rod in the rod saddle (410) with the cap (412) and the advancement of the set screw (414). The cap (412) can also include any number of features that interlock with the top portion of the tulip body (406) to resist post-operative splaying of the top portion of the tulip body (406). Additional aspects of the exemplary type of tulip assembly illustrated in
In addition to the exemplary screw system illustrated in
Referring to
Continuing with
The various embodiment of pedicle screws and/or pedicle screw systems, in particular the various tulip assemblies, have been provided and described for illustrative and exemplary purposes. The illustrated embodiments are not intended to limit or narrow the scope of the claims. It is understood and appreciated that other pedicle screw systems, pedicle screws, and/or tulip assemblies, not illustrated herein or some combination of those illustrated herein, can meet the spirit and scope of the claimed systems and methods.
As mentioned previously, the present exemplary system and method includes a kit (900) illustrated in
Once the pedicle screw is inserted into a vertebra, the surgeon may determine a type of tulip assembly is to be compressively coupled to the head portion of the pedicle screw (step 1010). According to one exemplary embodiment, the surgeon may select any number of the above-mentioned exemplary tulip assemblies, or a number of other similar compressively coupling members. Consequently, the surgeon may select the tulip assembly that will best serve the patient's situation. Once selected, the identified tulip assembly may then be installed (step 1020).
Various embodiments of the present assemblies, devices, and systems have been described herein. It should be recognized, however, that these embodiments are merely illustrative of the principles of the present assemblies, devices, and systems. Numerous modifications and adaptations thereof will be apparent to those skilled in the art without departing from the spirit and scope of the present assemblies, devices, and systems.
The various embodiments described above can be combined to provide further embodiments. All of the above U.S. patents, patent applications and publications referred to in this specification as well as U.S. Provisional Patent Application No. 60/622,107 filed on Oct. 25, 2004, entitled CLIP LOCK PEDICLE SCREW; U.S. Provisional Patent Application No. 60/622,180 filed on Oct. 25, 2004, entitled POLY-AXIAL PEDICLE SCREW; U.S. Provisional Patent Application No. 60/629,785 filed on Nov. 19, 2004, entitled POLY-AXIAL PEDICLE SCREW; U.S. Provisional Patent Application No. 60/663,092 filed on Mar. 18, 2005, entitled MASTER LOCK PEDICLE SCREW; U.S. Provisional Patent Application No. 60/684,697 filed on May 25, 2005, entitled POLY AXIAL PEDICLE SCREW; and U.S. Provisional Patent Application No. 60/665,032, filed on Mar. 23, 2005, entitled PERCUTANEOUS PEDICLE SCREW SYSTEM, are incorporated herein by reference, in their entirety. Aspects of the exemplary system and method can be modified, if desired, to employ devices, features, and concepts of the various patents, applications and publications to provide yet further embodiments of the system and method.
In conclusion, the present exemplary systems and methods provide for modular pedicle screw systems and methods. Particularly, the present exemplary system and methods incorporate a number of pedicle screws and/or tulip assemblies configured to be combined to create pedicle screw kits that may be advantageously modified and assembled intra-operatively. Consequently, the present exemplary system and method provides a surgeon the option to vary their tulip selection once the surgical site is visually evaluated.
The preceding description has been presented only to illustrate and describe the present method and system. It is not intended to be exhaustive or to limit the present system and method to any precise form disclosed. Many modifications and variations are possible in light of the above teaching.
The foregoing embodiments were chosen and described in order to illustrate principles of the system and method as well as some practical applications. The preceding description enables others skilled in the art to utilize the method and system in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the present exemplary system and method be defined by the following claims.
This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 60/723,324 filed Oct. 4, 2005 titled “Modular Pedicle Screw Systems and Methods of Interoperably Assembling the Same.” The provisional application is incorporated herein by reference in its entirety.
Number | Date | Country | |
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60723324 | Oct 2005 | US |