Patent Publication Number: US-2020289178-A1

Title: Self-aligning plating system and method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application claims the benefit of co-pending U.S. provisional application No. 62/791,732, filed on Jan. 11, 2019, the entire disclosure of which is incorporated by reference as if set forth in its entirety herein. 
    
    
     TECHNICAL FIELD 
     Embodiments of the present invention generally relate to medical devices and, more particularly but not exclusively, to medical devices for properly positioning interbody devices with respect to a patient&#39;s anatomy. 
     BACKGROUND 
     Medical devices are frequently misaligned with respect to a patient&#39;s anatomy during or after placement. Cervical and lumbar fusion plates, for example, are often not precisely cephalad and caudad. These imprecise alignments may often only be detected by postoperative x-rays, which may show these plates or other devices at varying degrees of alignment that are off-center with respect to the patient&#39;s anatomy. This is visually displeasing (e.g., as apparent from postoperative X-rays) and clinically sub-optimal. 
     These types of misalignments are generally due to obfuscated operative views of a patient&#39;s anatomy. For example, soft tissue and intraoperative bleeding may affect a surgeon&#39;s field of view of the patient&#39;s anatomy during device placement. 
     On the other hand, minimally invasive surgical approaches inevitably reduce visibility and cause the surgeon to lose his or her orientation of the applicable medical device and/or the patient&#39;s anatomy. While being fixated to the patient&#39;s anatomy, the plate itself may also obscure the surgeon&#39;s view of the patient&#39;s anatomy. The surgeon&#39;s operative proficiency, knowledge, experience, and skill may also impact their ability to properly align medical devices with respect to the patient&#39;s anatomy. 
     Existing techniques to address these issues generally require the surgeon to take radiographs to see the device&#39;s implanted orientation and then make adjustments thereto. The surgeon may be required to take multiple X-rays as well, which is expensive, time-consuming, and a hazard to the health of the patient, surgeon, and surgical team. 
     During subsequent adjustment(s), the medical device may shift while the surgeon is trying to fixate it. This is particularly true without the aid of a temporary fixation device. This adds surgical time, increases the risk of infection, and increases the potential for other intraoperative complications. While guidewires have been used in surgery for many years, they only assist in aligning a device to a target area. 
     The result of these above-discussed problems is that surgeons generally rely on manual or inexact approaches to align medical devices with respect to a patient&#39;s anatomy. Unfortunately, the medical community has generally accepted these clinically sub-optimal, time-consuming, and costly techniques. 
     A need exists, therefore, for systems and methods that overcome the disadvantages of existing techniques. 
     SUMMARY 
     This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description section. This summary is not intended to identify or exclude key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. 
     In one aspect, embodiments described herein generally relate to a self-aligning plating system. The system includes an interbody spacer having a first gendered coupling mechanism; a medical device plate; and an insertion member, the insertion member having a second gendered coupling mechanism, wherein: the gender of the first gendered coupling mechanism is the opposite gender of the second gendered coupling mechanism, the interbody spacer is configured to be inserted between adjacent vertebrae of a spinal column, the insertion member is configured to be operably connected to the interbody spacer at the first and second gendered coupling mechanisms, the medical device plate is configured to slide over the insertion member and operably connect to the interbody spacer and align with the adjacent vertebrae, and after the medical device plate is attached to the adjacent vertebrae, the insertion member is configured to be detached from the interbody spacer and medical device plate at the first and second gendered coupling mechanisms. 
     In some embodiments, the insertion member is operably shaped to receive the medical device plate. 
     In some embodiments, the insertion member is operably shaped to receive the interbody spacer. 
     In some embodiments, the first gendered coupling mechanism is a female coupling mechanism. 
     In some embodiments, the first gendered coupling mechanism is a male coupling mechanism. 
     In some embodiments, the medical device plate is attached with at least one screw. 
     In some embodiments, the spacer is at least one of a plastic, ceramic, metal, autograft, or allograft spacer. 
     In some embodiments, the insertion member can be pinched to remove the insertion member from the spacer. 
     In some embodiments, the spacer is configured to be at least one of a cervical, thoracic, or lumbar spacer. 
     In some embodiments, the medical device plate can be in contact with a plurality of spacers simultaneously to fixate a plurality of vertebrae. 
     According to another aspect, embodiments, relate to a method of attaching a medical device plate and interbody spacer to a spinal column. The method includes inserting an interbody spacer between adjacent vertebrae of the spinal column, the interbody spacer having a first gendered coupling mechanism; operably connecting an insertion member to the interbody spacer, the insertion member having a second gendered coupling mechanism, wherein the gender of the first gendered coupling mechanism is the opposite gender of the second gendered coupling mechanism; sliding the medical device plate along the insertion member to position the medical device plate over the interbody spacer; aligning the medical device plate at the adjacent vertebrae; attaching the medical device plate to the adjacent vertebrae; and detaching the insertion member from the interbody spacer. 
     In some embodiments, the insertion member is operably shaped to receive the medical device plate. 
     In some embodiments the insertion member is operably shaped to receive the interbody spacer. 
     In some embodiments, the first gendered coupling mechanism is a female coupling mechanism. 
     In some embodiments, the first gendered coupling mechanism is a male coupling mechanism. 
     In some embodiments, the medical device plate is attached with at least one screw. 
     In some embodiments, the spacer is at least one of a plastic, ceramic, metal, autograft, or allograft spacer. 
     In some embodiments, the insertion member can be pinched to remove the insertion member from the spacer. 
     In some embodiments, the spacer is configured to be at least one of a cervical, thoracic, or lumbar spacer. 
     In some embodiments, the method further includes removing the insertion member from a hole in the medical device plate; exposing the hole in the medical device plate; and attaching the medical device plate to at least one vertebrae of the adjacent vertebrae at the exposed hole 
     In some embodiments, the medical device plate can be in contact with a plurality of spacers simultaneously to fixate a plurality of vertebrae. 
     According to another aspect, embodiments relate to a self-aligning plating system, the system. The system includes an interosseous spacer having a first gendered coupling mechanism; a medical device plate; and an insertion member, the insertion member having a second gendered coupling mechanism, wherein the gender of the first gendered coupling mechanism is the opposite gender of the second gendered coupling mechanism; the interosseous spacer is configured to be inserted between two or more bone elements of a spinal column; the insertion member is configured to be operably connected to the interosseous spacer at the first and second gendered coupling mechanism; the medical device plate is configured to slide over the insertion member and operably connect to the interbody spacer and align with the two or more bone elements; and after the medical device plate is attached to the two or more bone elements, the insertion member is configured to be detached from the interosseous spacer and medical device plate at the first and second gendered coupling mechanisms. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       Non-limiting and non-exhaustive embodiments of this disclosure are described with reference to the following figures, wherein like reference numerals refer to like parts throughout the various views unless otherwise specified. 
         FIGS. 1A &amp; 1B  illustrate a self-aligning plating system  100  in accordance with one embodiment; 
         FIGS. 2A-2D  illustrate the interbody spacer  102  of  FIGS. 1A and 1B  in accordance with one embodiment; 
         FIGS. 3A &amp; 3B  illustrate the medical device plate  104  of  FIGS. 1A and 1B  in accordance with one embodiment; 
         FIG. 4  illustrates a self-aligning plating system  100  secured to a patient in accordance with one embodiment; 
         FIG. 5  illustrates a self-aligning plating system secured to a patient in accordance with another embodiment; 
         FIG. 6  illustrates the insertion member  502  of the self-aligning plating system of  FIG. 5  in accordance with one embodiment; and 
         FIG. 7  depicts a flowchart of a method of attaching a medical device plate and interbody spacer to a spinal column in accordance with one embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Various embodiments are described more fully below with reference to the accompanying drawings, which form a part hereof, and which show specific exemplary embodiments. However, the concepts of the present disclosure may be implemented in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided as part of a thorough and complete disclosure, to fully convey the scope of the concepts, techniques and implementations of the present disclosure to those skilled in the art. Embodiments may be practiced as methods, systems or devices. The following detailed description is, therefore, not to be taken in a limiting sense. 
     Reference in the specification to “one embodiment” or to “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiments is included in at least one example implementation or technique in accordance with the present disclosure. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment. The appearances of the phrase “in some embodiments” in various places in the specification are not necessarily all referring to the same embodiments. 
     In addition, the language used in the specification has been principally selected for readability and instructional purposes and may not have been selected to delineate or circumscribe the disclosed subject matter. Accordingly, the present disclosure is intended to be illustrative, and not limiting, of the scope of the concepts discussed herein. 
     The embodiments described herein provide novel self-aligning plating systems and methods. The disclosed systems may include an interbody spacer, a medical device plate, and an insertion member. In use, the interbody spacer is configured to be inserted between two portions of a patient&#39;s anatomy, such as between adjacent vertebrae of the patient&#39;s spinal column. This interbody spacer essentially serves as an alignment tool, onto which the medical device plate is positioned to contact the anatomy portion(s). 
       FIG. 1A  illustrates an exploded view a self-aligning plating system  100  in accordance with one embodiment. As seen in  FIG. 1A , the self-aligning plating system  100  may include an interbody spacer  102 , a medical device plate  104 , an insertion member  106 , and an optional extension member  108  to operably engage the insertion member  106  during alignment/insertion.  FIG. 1B  illustrates the components of the self-aligning plating system  100  of  FIG. 1A  in contact with each other such as during placement of the interbody spacer  102  and the medical device plate  104 . 
     The interbody spacer  102  may be made of plastic and include or otherwise be configured with a first gendered coupling mechanism, and the insertion member  106  may include or otherwise be configured with a second gendered coupling mechanism such that the interbody spacer  102  and the insertion member  106  can operably engage each other. The interbody spacer  102  may be a ceramic, metal, autograft, or allograft spacer in some embodiments. In some embodiments, the first gendered coupling mechanism may be a female coupling mechanism and the second gendered coupling mechanism may be a male coupling mechanism. In some embodiments, the first gendered coupling mechanism may be a male coupling mechanism and the second gendered coupling mechanism may be a female coupling mechanism. The exact configurations of the first and second gendered coupling mechanisms may vary as long as the interbody spacer  102  and the insertion member  106  can operably engage each other to accomplish the objectives of the embodiments described herein. 
     During placement, the interbody spacer  102  may be inserted between two portions of a patient&#39;s anatomy such as between a top and bottom vertebra. This placement may be facilitated by the insertion member via engagement between the above-discussed first and second gendered coupling mechanisms. The medical device plate  104  may then be positioned at one end of the insertion member  106 , and slid over the insertion member  106  to eventually come into contact with the interbody spacer  102  and the patient anatomy portion(s). 
     The configuration of the interbody spacer  102 , the medical device plate  104 , and the insertion member  106  may vary as long as a surgeon can properly position the required components with respect to the patient&#39;s anatomy. For example, the medical device plate  104  may be configured with one or more hexagonal-shaped holes, and the insertion member  106  may include a hexagonal-shaped perimeter such that the medical device plate  104  can slide over the perimeter of the insertion member  106  to contact the interbody spacer  102 . 
       FIGS. 2A-2D  illustrate multiple views of an interbody spacer  202  in accordance with one embodiment. The interbody spacer  202  may be similar to the interbody spacer  102  of  FIGS. 1A-1B , for example. 
       FIGS. 2A-2B  illustrate perspective and top views of the interbody spacer  202 , respectively.  FIG. 2C  illustrates a cross-sectional view of the interbody spacer  202  and  FIG. 2D  illustrates a front view of the interbody spacer  202 . As seen in  FIGS. 2A-2D , the interbody spacer  202  includes an alignment hole  204  to assist in aligning a plate such as the medical device plate  104  of  FIGS. 1A-1B . 
     The alignment hole  204  may serve as a female coupling mechanism such that it can receive a male coupling mechanism of the insertion member  106 . The alignment hole  204  may be formed of a plurality of threads such that it can receive a screw with threaded portions, for example. 
       FIGS. 3A-3B  illustrate a medical device plate  302  in accordance with one embodiment. As seen in  FIGS. 3A-3B , the medical device plate  302  may include one or more alignment holes  304 . In this particular embodiment, the alignment hole(s)  304  on the medical device plate  302  are hexagonal-shaped. The exact shape and size of the alignment hole(s)  304  on the plate  302  may vary as long they can receive the insertion member and operably connect to the interbody spacer for proper alignment with respect to the interbody spacer  102  and patient anatomy. 
     The plate may further include lines, groves, or some other indicia to indicate and achieve proper alignment. Once properly aligned with the interbody spacer, the medical device plate may be secured to the patient using any suitable technique(s). 
     In operation, and with reference to  FIGS. 1A &amp; 1B , a surgeon may place the interbody spacer  102  at an appropriate position with respect to a patient&#39;s anatomy. If the surgeon hadn&#39;t previously done so, he or she may then operably connect the insertion member  106  with the interbody spacer  102  (e.g., into an alignment hole of the interbody spacer  102  such as the alignment hole  204  of  FIGS. 2A-2D ). 
     Once the insertion member  106  is operably connected with the interbody spacer  102 , the surgeon may place the medical device plate  104  on the insertion member  106  such that the insertion member  106  can then “pass through” a hole of the medical device plate  104 . The surgeon may then slide the medical device plate  104  along the length of the insertion member  106  until it comes into contact with the patient&#39;s anatomy (e.g., adjacent vertebrae) and the interbody spacer  102 . The medical device plate  104  would therefore be properly aligned with respect to the patient&#39;s anatomy in the correct coronal, axial, and sagittal orientations. 
     The insertion member  106  may serve as a temporary fixation of the plate to the patient&#39;s anatomy, such as before the medical device plate  104  is secured to the patient. This alignment can also be used for other surgical or medical templates/guides. For example, the insertion member  106  may be used to deliver organic and/or inorganic bone void/bone grafting materials or extenders. 
       FIG. 4  illustrates a self-aligning plating system  400  secured to a patient in accordance with one embodiment. In this embodiment, an interbody spacer  402  is positioned between a top vertebra  404  and a bottom vertebra  406  of a patient&#39;s anatomy. A medical device plate  408  that includes a hexagonal-shaped hole has been slid over an insertion member  410  to come into contact with the interbody spacer  402 , the top vertebra  404 , and the bottom vertebra  406 . The medical device plate  408  has been secured to the top and bottom vertebra  404  and  406 , respectively, by a plurality of screws  412 . Once the medical device plate  408  is secured, the insertion member  410  may be detached from the interbody spacer  402 . 
     Although only two vertebra are shown in  FIG. 4 , the medical device plate  408  may contact more than two vertebra. For example, there may be two interbody spacers operably positioned with respect to a patient&#39;s anatomy, such as a first interbody spacer positioned between a top vertebra and a middle vertebra, and a second interbody spacer positioned between the middle vertebra and a bottom vertebra. In this scenario, a medical device plate may contact each interbody spacer to fixate a plurality of vertebra. 
     In some embodiments, when the insertion member  410  is removed from the medical device plate  408 , a hole  414  in the medical device plate  408  may be exposed. Once the hole  408  is exposed, the plate  410  may be secured to at least one vertebra or the interbody spacer  402 . The medical device plate  408  may be secured with a screw, stake, nail, or other fixture in some embodiments. 
       FIG. 5  illustrates another embodiment in which the insertion member  502  is configured as a standalone component.  FIG. 6  illustrates the insertion member  502  of  FIG. 5  in accordance with one embodiment. Once the medical device plate has been secured to the patient, the surgeon may apply pressure to squeeze the insertion member  502  to disengage and detach the insertion member  502  from the patient (and the interbody spacer). In some embodiments, the insertion member  502  may be passively attached and detached from the interbody spacer. In some embodiments, the insertion member  502  may be actively attached and detached from the interbody spacer. For example, the insertion member  502  may be pinched to remove the insertion member from the interbody spacer. 
       FIG. 7  depicts a flowchart of a method  700  for attaching a medical device plate and interbody spacer to a spinal column in accordance with one embodiment. Step  702  involves inserting an interbody spacer between adjacent vertebrae of the spinal column. The interbody spacer of step  702  may be similar to the interbody spacer  102  of  FIG. 1  and have a first gendered coupling mechanism. 
     Step  704  involves operably connecting an insertion member to the interbody spacer, the insertion member having a second gendered coupling mechanism. The gender of the first gendered coupling mechanism is the opposite gender of the second gendered coupling mechanism. 
     Step  706  involves sliding the medical device plate along the insertion member to position the medical device plate over the interbody spacer. The medical device plate may be similar to the medical device plate  104  of  FIG. 1  and include at least one hole or aperture to slide along the length of the insertion member  106 . The medical device plate may slide along the insertion member  106  until it comes into contact with the patient&#39;s anatomy. 
     Step  708  involves aligning the medical device plate at the adjacent vertebrae. By virtue of its sliding along the insertion member and coming into contact with the patient&#39;s anatomy, the medical device plate may be properly aligned with the patient&#39;s anatomy. 
     Step  710  involves attaching the medical device plate to the adjacent vertebrae. The medical device plate may be secured to the patient&#39;s anatomy via one or more screws, for example. 
     Step  712  involves detaching the insertion member from the interbody spacer. Once the medical device plate is properly secured to patient&#39;s anatomy, the insertion member may be removed from the interbody spacer. 
     In some embodiments, the medical device plate and the spacer may be attached to bone elements other than a spinal column. For example, the medical device plate and an interosseus spacer may be attached to fixate two bone elements of a broken bone. 
     The methods, systems, and devices discussed above are examples. Various configurations may omit, substitute, or add various procedures or components as appropriate. For instance, in alternative configurations, the methods may be performed in an order different from that described, and that various steps may be added, omitted, or combined. Also, features described with respect to certain configurations may be combined in various other configurations. Different aspects and elements of the configurations may be combined in a similar manner. Also, technology evolves and, thus, many of the elements are examples and do not limit the scope of the disclosure or claims. 
     Embodiments of the present disclosure, for example, are described above with reference to block diagrams and/or operational illustrations of methods, systems, and devices according to embodiments of the present disclosure. The functions/acts noted in the blocks may occur out of the order as shown in any flowchart. For example, two blocks shown in succession may in fact be executed substantially concurrent or the blocks may sometimes be executed in the reverse order, depending upon the functionality/acts involved. Additionally, or alternatively, not all of the blocks shown in any flowchart need to be performed and/or executed. For example, if a given flowchart has five blocks containing functions/acts, it may be the case that only three of the five blocks are performed and/or executed. In this example, any of the three of the five blocks may be performed and/or executed. 
     A statement that a value exceeds (or is more than) a first threshold value is equivalent to a statement that the value meets or exceeds a second threshold value that is slightly greater than the first threshold value, e.g., the second threshold value being one value higher than the first threshold value in the resolution of a relevant system. A statement that a value is less than (or is within) a first threshold value is equivalent to a statement that the value is less than or equal to a second threshold value that is slightly lower than the first threshold value, e.g., the second threshold value being one value lower than the first threshold value in the resolution of the relevant system. 
     Specific details are given in the description to provide a thorough understanding of example configurations (including implementations). However, configurations may be practiced without these specific details. For example, well-known circuits, processes, algorithms, structures, and techniques have been shown without unnecessary detail in order to avoid obscuring the configurations. This description provides example configurations only, and does not limit the scope, applicability, or configurations of the claims. Rather, the preceding description of the configurations will provide those skilled in the art with an enabling description for implementing described techniques. Various changes may be made in the function and arrangement of elements without departing from the spirit or scope of the disclosure. 
     Having described several example configurations, various modifications, alternative constructions, and equivalents may be used without departing from the spirit of the disclosure. For example, the above elements may be components of a larger system, wherein other rules may take precedence over or otherwise modify the application of various implementations or techniques of the present disclosure. Also, a number of steps may be undertaken before, during, or after the above elements are considered. 
     Having been provided with the description and illustration of the present application, one skilled in the art may envision variations, modifications, and alternate embodiments falling within the general inventive concept discussed in this application that do not depart from the scope of the following claims.