Patent Publication Number: US-2023149054-A1

Title: En bloc connector

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 63/281,067 filed Nov. 18, 2021, which is incorporated herein by reference. 
    
    
     FIELD 
     The present invention relates generally to the field of surgery, and more specifically, to En Bloc connector for use with reducers in spinal fusion surgery. 
     BACKGROUND 
     The spine is a series of individual bones called vertebrae. A normal spine has no side-to-side curve but does have a series of front-to-back curves, giving it a gentle “S” shape. Many people have an abnormal curvature of the spine and it may be necessary to straighten or adjust the spine into a proper curvature and alignment. 
     Spinal surgical procedures have been developed to correct the abnormal curvature of the spine. One procedure involves placing multiple pedicle screws into the vertebrae of the curved region and coupling spinal fixation rods to the screw heads. The rods are shaped to mimic the normal curvature and force the spine into proper alignment once positioned within the screw head. The rods are then secured or locked to the screws maintain the curvature. 
     The Spinal surgical procedures can require complex movement and manipulation of the vertebrae to restore normal curvature to the patient. The manipulation may include a rotational force applied on pedicle screws in the coronal plane (medial-laterally) is referred to as “derotation”. This is usually done by applying compression and/or distraction forces of a derotation instrument to vertebrae via the screw extenders. 
     Current competitive deformity instrumentation, specifically in the sector of direct vertebrae rotation (DVR), lack the functional performance needed to meet current market needs. Current En Bloc offerings include connectors of varying sizes of fixed length that require the surgeon to have many sizes of connectors available. This results in the surgeon often having to test fit a size before finding the correct size. This is very inconvenient and time consuming during an operation. 
     Accordingly, there remains a need for instruments and methods that provide solutions to the problems of current systems. The present invention is directed toward meeting these needs. 
     SUMMARY 
     An En Bloc connector configured to couple with multiple sequential reducers or extenders, such as spinal screw reducers, to correct a rotation deformity of the spine by turning or rotating the deformed spine structure toward a normal position. In the embodiments shown, the En Bloc connector holds three sequential reducers in the retracted configuration and four sequential reducers in the extended configuration. In other embodiments, the En Bloc connector may a different number of sequential reducers, such as between 2 and twelve sequential reducers  102 . 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    shows one embodiment of an En Bloc connector in a retracted configuration. 
         FIG.  2    shows the En Bloc connector in an extended configuration. 
         FIG.  3    shows one example of the En Bloc connector holding three sequential reducers. 
         FIG.  4    is a sectional view at A-A of  FIG.  3   . 
         FIG.  5    shows one example of the En Bloc connector that has been extended to hold additional sequential reducers. 
         FIG.  6    is a sectional view at B-B of  FIG.  5   . 
         FIG.  7    is a sectional view at C-C of  FIG.  5   . 
         FIGS.  8 - 10    show some of the steps in loading sequential rod reducers in the En Bloc connector of  FIG.  1   . 
         FIGS.  11  and  12    show some of the steps in loading sequential rod reducers in the extended En Bloc connector of  FIG.  3   . 
         FIGS.  13  and  14    show two different configurations of the En Bloc connector. 
     
    
    
     DETAILED DESCRIPTION 
     Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and/or alternatives of the embodiments described herein. 
     It will be understood that the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. 
     It will be further understood that, although the terms first, second, third etc. may be used herein to describe various limitations, elements, components, regions, layers and/or sections, these limitations, elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application. 
     The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of” according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component. 
     It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way. 
     It is to be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the invention, a description of such elements is not provided herein. 
       FIG.  1    shows one embodiment of an En Bloc connector  100  in a retracted configuration and  FIG.  2    shows the En Bloc connector  100  in an extended configuration. The En Bloc connector  100  is configured to couple with multiple sequential reducers  102  or extenders, such as spinal screw reducers, to correct a rotation deformity of the spine by turning or rotating the deformed spine structure toward a normal position. In the embodiments shown, the En Bloc connector  100  holds three sequential reducers  102  in the retracted configuration and four sequential reducers  102  in the extended configuration. In other embodiments, the En Bloc connector  100  may a different number of sequential reducers  102 , such as between 2 and twelve sequential reducers  102 . 
     The En Bloc connector  100  includes a first arm  104  and a second arm  106  coupled to a first hinge pin  108  at a first end  100   a  and an arm closure mechanism  110  at a second end  100   b . The arm closure mechanism may be an arm locking mechanism  110 . The first and second arms  104 ,  106  of the En Bloc connector  100  are parallel and separated by a distance W and having a length L 1 , creating an area for multiple sequential reducers  102  to be locked in place. 
     The first arm  104  includes a first fixed portion  112  on a proximal end slidingly coupled to a first telescoping portion or first extendable portion  114  on a distal end. The second arm  106  includes a second fixed portion  120  on a proximal end slidingly coupled to a second telescoping portion or extendable portion  122  on a distal end. The proximal end of the first fixed portion  112  includes an inwardly curved portion  116  having a first pivot hole  118 . The proximal end of the second fixed portion  120  includes an inwardly curved portion  124  having a second pivot hole  126 . The inwardly curved portions  116 ,  124  of the first and second fixed portions  112 ,  124  are configured to overlap, and the first and second pivot holes  118 ,  126  are in alignment. The first hinge pin  108  is configured to fit the first and second pivot holes  118 ,  126  so that the first fixed portion  112  is rotatingly coupled to the second fixed portion  120  with the first hinge pin  108 . 
     The first and second extendable portions  114 ,  122  are positioned within t-slots  132 ,  134  of the first and second fixed portions  112 ,  120 . In the embodiment shown, the t-slots  132  can be other shapes of slots or recesses. The first and second fixed portions  112 ,  114  and first and second extendable portions  114 ,  122  include inwardly facing surfaces  112   a ,  114   a .  120   a ,  122   a  designed to make contact with the sequential reducer  102 . The design of the t-slots  134 ,  136  allow for the inward facing surfaces  112   a ,  114   a ,  120   a ,  122   a  to contact the sequential rod reducer  102  when the first and second fixed portions  112 ,  120  and first and second extendable portions  114 ,  122  are at any of its positions. 
     The En Bloc connector  100  include features to extend the length of the first and second arms  104 ,  106  from L 1  ( FIG.  1   ) to L 2  ( FIG.  2   ) to hold more sequential reducers  102 . The first and second extendable portions  114 ,  122  are designed to slide from the first and second fixed portions  112 ,  120 . The first and second extendable portions  114 ,  122  are locked within slots  132 ,  134  of the first and second fixed portions  112 ,  120  by first and second extendable portion locks or clips  136 ,  138 . When the first and second extendable portion locks  136 ,  138  are depressed or squeezed inward toward each other, they disengage the first and second extendable portions  114 ,  122 , allowing them to extend. When the desired extension length L 2  is reached, the first and second extendable portion locks  136 ,  138  are released, and the extendable portions  114 ,  122  are locked in place. The extendable portions  114 ,  122  may be locked in incremental positions. The extendable portions  114 ,  122  may include laser markings  140  showing different positions or length marks. 
     The length L of the first and second extendable portions  104 ,  106  may be extended during surgery to hold more sequential reducers  102  without having to change to a different En Bloc connector  100 . 
     The arm locking mechanism  110  is rotatingly coupled to the distal end of the first extendable portion  114  with a second hinge pin  128  and releasably coupled to the distal end of the second extendable portion  114  with an arm locking device  130 , such as a knob. In some embodiments, the arm locking mechanism  110  may be tightened through a screw mechanism built within the arm locking mechanism  110 . In some embodiments, the arm locking mechanism  110  snap fits into the second arm ( 106 ) to reach the “closed” or “locked” position. 
     When the arm locking device  130  is unlocked, the first and second arms  104 ,  106  are configured to rotate from the closed position to an open position, discussed below. 
       FIG.  3    shows one example of the En Bloc connector  100  holding three sequential reducers  102  or extenders between the first and second arms  104 ,  106 . The inwardly facing surfaces  112   a ,  114   a  of the first and second fixed portions  112 ,  114  and the inwardly facing surfaces  120   a ,  122   a  of the first and second extendable portions  114 ,  122  contacting the sequential reducer  102 . The design of the t-slots  132 ,  134  allow the inward facing surfaces of the first and second fixed portions  112 ,  120  and first and second extendable portions  114 ,  122  to contact the sequential reducers  102  at any of their positions between retraced and extended. 
       FIG.  4    is a sectional view at A-A showing features of the first and second arms  104 ,  106 . In the embodiment shown, the first fixed portion  120  includes a t-slot  132  sized for the first extendable portion  114 . The first fixed portion  112  and first extendable portion  114  include inwardly facing surfaces  112   a ,  114   a  designed to make contact with the sequential reducer  102 . The second fixed portion  120  and second extendable portion  122  include inwardly facing surfaces  120   a ,  122   a  designed to make contact with the sequential reducer  102 . The t-slots  132 ,  134  allow contact between the inwardly facing surfaces  112   a ,  114   a ,  120   a ,  123   a  and the sequential rod reducer  102  when the first and second fixed portions  112 ,  120  and first and second extendable portions  114 ,  122  are at any of their positions. 
       FIG.  5    shows one example of the En Bloc connector  100  that has been extended to hold additional sequential reducers  102 , such as four sequential reducers  102 , between the first and second arms  104 ,  106 , with the first and second extendable portions  114 ,  122  in an extended position. The first and second extendable portions  114 ,  122  are locked within the first and second t-slots  132 ,  134  of the first and second fixed portions  112 ,  120  by the first and second extendable portion locks  136 ,  138 . When the first and second extendable portion locks  136 ,  138  are depressed inward, they disengage from the first and second extendable portions  114 ,  122 , allowing them to extend from the first and second fixed portions  112 ,  120 . In some embodiments when the locking mechanism is locked, the lengths of the first and second extendable portions  114 ,  122  may be adjusted at the same time. When the desired extension is reached, the first and second extendable portion locks  136 ,  138  are released and lock the extendable portions  114 ,  122  with the first and second fixed portions  112 ,  120 . The extendable portions  114 ,  122  may be locked in incremental positions. The extendable portions  114 ,  122  may include laser markings  140  showing different positions or distances. The laser marks may also show additional information. 
       FIG.  6    is a sectional view at B-B showing the first and second fixed portions  112 ,  120  holding the sequential reducers  102 . The extendable portions have been extended, leaving the t-slots  132 ,  134  empty. The inwardly facing surfaces  112   a ,  120   a  making contact with the sequential reducers  102 . 
       FIG.  7    is a sectional view at C-C showing the first and second extendable portions  114 ,  122  in the extended position with the inwardly facing surfaces  114   a ,  122   a  making contact with the sequential reducer  102 . 
     As discussed above, t-slots allow for contact between the first and second fixed portion surfaces  112   a ,  120   a  and first and second extendable portion surfaces  114   a ,  122   a  to make contact with the sequential rod reducer  102  when the first and second fixed portions  112 ,  120  and first and second extendable portions  114 ,  122  are at any of its positions. 
       FIGS.  8 - 10    show some of the steps in loading sequential rod reducers  102  in the En Bloc connector  100  of  FIG.  1   . 
       FIG.  8    shows the arm locking mechanism  110  unlocked from the second extendable portion  122  and rotated downward  142 . The second arm  106  is rotated upward  144 , so that the En Bloc connector  100  is in the open position.  FIG.  9    shows the end of the second extendable portion  122  having a slot or opening  123  sized to engage the arm locking mechanism  110 .  FIG.  10    shows the En Bloc connector  100  with three sequential rod reducers  102 . 
     Once the arm locking mechanism  110  unlocked it is rotated downward  142  and the second arm  106  may be rotated upward  144 , positioning the En Bloc connector  100  in the open position. The second end  100   b  of the En Bloc connector is now open for insertion of the sequential rod reducers  102 .  FIG.  10    shows the sequential rod reducers  102  in place and the second arm  106  is rotated downward  146  until the inwardly facing surfaces  120   a ,  122   a  engage the sequential rod reducers  102 . The arm locking mechanism  110  is then rotated upward  148  and the arm locking device  130  engages slot  123  locks to the second extendable portion  122 . The En Bloc connector  100  is now ready for use. 
       FIGS.  11  and  12    show some of the steps in loading sequential rod reducers  102  in the extended En Bloc connector  100  of  FIG.  3   . 
     In  FIG.  11    shows the arm locking device  130  unlocked from the second extendable portion  122  and rotated downward  142  and the second arm  106  is rotated upward  144 , positioning the En Bloc connector  100  in the open position. The second end  100   b  of the extended En Bloc connector  100  is open for insertion of the sequential rod reducers  102 .  FIG.  12    shows the sequential rod reducers  102  in place and the second arm  106  is rotated downward  146  until the inwardly facing surfaces  120   a ,  122   a  engage the sequential rod reducers  102 . The arm locking mechanism  110  is then rotated upward  148  and the arm locking device  130  engages slot  123  locks to the second extendable portion  122 . The extended En Bloc connector  100  is now ready for use. 
       FIGS.  13  and  14    show two different configurations of the En Bloc connector  100 .  FIG.  13    shows a first a first configuration of the En Bloc connector  100  with the first and second arms  104 ,  106  not extended and holding three sequential rod reducers  102 .  FIG.  14    shows a second configuration of the En Bloc connector  100  with the first and second arms  104 ,  106  extended and holding four sequential rod reducers  102 . 
     Example embodiments of the methods and systems of the present invention have been described herein. As noted elsewhere, these example embodiments have been described for illustrative purposes only and are not limiting. Other embodiments are possible and are covered by the invention. Such embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments but should be defined only in accordance with the following claims and their equivalents.