Patent Publication Number: US-2020281737-A1

Title: Spinal implant and method for forming spinal implant

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a non-provisional application of provisional application 62/815,781 filed on Mar. 8, 2019 the disclosure of which is hereby incorporated herein by reference in its entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     One embodiment of the invention relates to a spinal implant that is printed in a three-dimensional manner. The spinal implant can comprise an outer frame and a lattice. There is a need for a spinal implant that has a lattice orientation that allows for visual evaluation of the spinal implant once it is implanted into a user&#39;s body. 
     SUMMARY OF THE INVENTION 
     In at least one embodiment there is an implant for a spine comprising a frame having at least one face having a plurality of supports such as ribs. Inside of the frame there is a lattice. In addition, there is at least one opening in the frame exposing said lattice, wherein said lattice extends beyond said frame to form greater interactions with adjacent bone structure. 
     In addition there can also be a process for producing an implant comprising: determining a size of an implant frame; determining a size of an implant lattice; determining an orientation of the implant in a body; determining a first orientation of a lattice inside of the frame; graphically forming the implant; determining the opacity of the lattice inside of the frame from a first viewpoint; reorienting the lattice inside of the frame; determining the opacity of the lattice at a second orientation; determining which orientation results in lower opacity; and selecting the lattice orientation at a lower opacity. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Other objects and features of the present invention will become apparent from the following detailed description considered in connection with the accompanying drawings which disclose at least one embodiment of the present invention. It should be understood, however, that the drawings are designed for the purpose of illustration only and not as a definition of the limits of the invention. 
       In the drawings, wherein similar reference characters denote similar elements throughout the several views: 
         FIG. 1A  is a cephalad/caudad view of the frame of the spinal implant; 
         FIG. 1B  is a anterior view of the spinal implant of  FIG. 1A . 
         FIG. 2A  is a side view which is either a-lateral view of the frame according to the orientation of  FIG. 1A ; 
         FIG. 2B  is an oblique perspective view of the frame based upon the orientation of  FIG. 1A ; 
         FIG. 3A  is a lateral view of the lattice portion of the implant; 
         FIG. 3B  is a cephalad/caudad oblique view of the lattice portion of the implant based upon the orientation of  FIG. 3A ; 
         FIG. 4A  is a cephalad/caudad view of the lattice portion of the implant based upon the orientation of  FIG. 3B ; 
         FIG. 4B  is an anterior view of the lattice portion of the implant based upon the orientation of  FIG. 4A ; 
         FIG. 5  is a cephalad/caudad oblique view of the implant with both the frame and the lattice of the implant; 
         FIG. 6A  is a cephalad/caudad view of frame and lattice portion of the implant based upon the orientation of  FIG. 5 ; 
         FIG. 6B  is an anterior view of the implant based upon the orientation of  FIG. 6A ; 
         FIG. 7  A is a lateral view of the implant with the section line A-A taken through it; 
         FIG. 7B  is a cephalad/caudad cross-sectional view of the implant based upon the view of  FIG. 7A ; 
         FIG. 8  is a lateral view of the view shown in  FIG. 7A ; 
         FIG. 9A  is an anterior view of a first embodiment of a first thickness; 
         FIG. 9B  is a lateral view of the view of  FIG. 9A ; 
         FIG. 9C  is an anterior view of a second embodiment of a second thickness; 
         FIG. 9D  is a lateral view of the embodiment of  FIG. 9C ; 
         FIG. 9E  is a anterior view of another embodiment; 
         FIG. 9F  is a lateral view of the embodiment of  FIG. 9E ; 
         FIG. 9G  is an anterior view of another embodiment; 
         FIG. 9H  is a lateral view of the embodiment of  FIG. 9G ; 
         FIG. 9I  is an anterior view of another embodiment; 
         FIG. 9J  is a lateral view of the embodiment of  FIG. 9I ; 
         FIG. 10A  is an anterior view of another embodiment; 
         FIG. 10B  is a lateral view of the embodiment of  FIG. 10A ; 
         FIG. 10C  is an anterior view of another embodiment; 
         FIG. 10D  is lateral view of the embodiment of  FIG. 10C ; 
         FIG. 10E  is a anterior view of another embodiment; 
         FIG. 10F  is a lateral view of another embodiment; 
         FIG. 11A  is a side view of a 3D image with the lattice at a first orientation; 
         FIG. 11B  is another side view of the lattice at a second orientation rotated to provide greater visualization of bone growth; 
         FIG. 12A  is a front perspective view of the lattice orientated in the frame; 
         FIG. 12B  is a front perspective view of a second orientation of the lattice in the frame; 
         FIG. 13A  is a side perspective view of a lattice structure; 
         FIG. 13B  is a side view of a honeycomb cell of the lattice structure; 
         FIG. 14A  is a view of a density profile of a first embodiment; 
         FIG. 14B  is a view of a density profile of a second embodiment; 
         FIG. 15  is a flow chart of the process for rotating the lattice screen to provide an optimal image to show bone growth before printing the implant. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       FIG. 1A  is an anterior view of the frame of the spinal implant which forms a first embodiment  10 . This embodiment includes a frame  11  which has a body section  12 . Coupled to body section  12  are struts  14 ,  16 ,  18  and  19 . In addition, these struts  14 ,  16 ,  18  and  19  are coupled to a central core  20  which forms a hub for the frame. Inside the core  20  is a hollow region  21 . On a first or front face there are a plurality of supports such as ribs including ribs  32  with intermittent indents or valleys  34  between the ribs  32 . In addition, there is an indent  22  in frame  11  which is configured to receive a lattice portion. 
       FIG. 1B  is an anterior view of the spinal implant of  FIG. 1A  with this side being a view based upon the orientation of the frame in  FIG. 1A . In this view there is frame  12  along with indents  24  and  26 . Indents  24  and  26  are configured to allow for greater handling of the frame during implantation of the frame during surgery, or for handling of the frame with forceps prior to insertion. Each of these indents  24  and  26  are formed as ramp-shaped indents. 
       FIG. 2A  is another lateral view which is either a left side view or a right-side view of the frame according to the orientation of  FIG. 1A . With this view the frame  11  has ribs  32  as well as relative indents or valleys  34 . There is also a side opening  36  which allows for side viewing inside of the frame. A bottom portion  17  is shown flared out forming an additional rib as well. While the terms “bottom”, “top”, “front”, “left”, and “right” are used, the implant can be implanted at any orientation and will most likely be implanted with the sides having ribs being positioned as top and bottom sides. 
       FIG. 2B  is an oblique perspective view of the frame based upon the orientation of  FIG. 1A . With this view there is shown frame portion  12  with struts  14 ,  16 ,  18  and  19  coupled to core  20 . Ribs  32  are shown with flat front surfaces, indents or valleys  34 . The bottom portion or face shows indents  24  and  26 . Along the sides are windows or openings  36  and  38 . 
     While the frame  11  with the outer frame portion  12  forms a first part of the implant there is another part of the implant which includes a lattice or screen. The lattice or screen is shown separate for purposes of display in  FIGS. 3A-4B , however, when the device is printed both the frame and the lattice are printed together. 
       FIG. 3A  is a lateral view of the lattice portion  50  of the implant  10 . With this design, there is a body section  51  which includes at least one face having ribs  52  as well as a substantially flat surface  54  which sits between the ribs  52 . There is also a base section  56  which forms a base block to the lattice. In addition, there is an extending portion  58  which extends up from the body section  51 . This lattice portion can have cells that are formed as hexagonal shaped cells which when put together with other cells form a repeating 3-dimensional hexagonal shape. 
       FIG. 3B  is an oblique view of the lattice portion  50  of the implant based upon the orientation of  FIG. 3A . In this view body section  51  includes a face  57  which has extending arch portion  58  extending out from face  57  in an arch. In addition, there is an intermediate extending portion  59  which extends up from face  57  to extending portion  58 . Ribs  52  are also shown, wherein these ribs extend between surface  54 . There is also shown a central core opening  60  which is configured to receive or be coupled around core  20 . The body section  51  can extend beyond a frame such as frame  12  so that it provides greater interaction between adjacent bones such as vertebrae. 
       FIG. 4A  is a cephalad/caudad view of the lattice portion  50  of the implant based upon the orientation of  FIG. 3B . This view shows body section  51 , as well as central core  60 . A top arch portion  58  is also shown. 
       FIG. 4B  is an anterior view of the lattice portion of the implant based upon the orientation of  FIG. 4A . In this view arch portion  58  is shown extending up from surface  57  along with extending portion  59 . There is also an extending section  61  which extends out from a base of the arch. 
       FIG. 5  is an oblique view of the implant  10  with both the frame and the lattice of the implant. The lighter portions of the implant  10  form the lattice section while the darker portions form the frame. With this view there is shown struts  14  as well as strut  65  which are each coupled to core  20 . Strut  65  extends between the cores  20  on each face. 
       FIG. 6A  is a cephalad/caudad view of frame and lattice portion of the implant  10  based upon the orientation of  FIG. 1A . With this view there is shown frame portion  12  which includes struts  14 ,  16 ,  18  and  19  as well as core  20  along with lattice portion  51  interposed between the struts and core  20 . In addition, extending section  22  extends into frame section  12  between indents  24  and  26  (See  FIG. 6B ) and in a region adjacent to non-indented portion  17 . In addition, as shown in  FIG. 6B  the lattice structure  51  can be extended in a proud manner above the frame such as frame  12  to provide for greater bone on lattice structure. In addition, in at least one embodiment the porosity of the lattice structure can vary depending on the depth into the implant. This feature is shown in U.S. patent application Ser. Nos. 15/614,423, and 15/585,441, 15/665,097 and 16/268,074 the disclosure of these applications being hereby incorporated herein by reference in its entirety. In addition, in this view there is shown the lattice structure  51  extending beyond the extension of the frame such as frame  12 . 
       FIG. 7A  is a lateral view of the implant with the section line A-A taken through it wherein this view includes ribs  32  as well as face portion  34 . A side opening  36  is shown along with indent  26 . A section line A-A is shown which is for the purpose of illustrating the cross-sectional view. 
       FIG. 7B  is a side cross-sectional view of the implant based upon the view of  FIG. 7  A wherein in this view there is a lattice  51  shown positioned inside of frame  12 . A plurality of side struts  62 ,  63 ,  64 , and  65  link the cores  20  together. Indents  24  and  26  are positioned on either side of non-indented portion  17 . A hollow core section  21  is also shown. 
       FIG. 8  is a lateral view of the view shown in  FIG. 7  A which shows indent  24  as well as window opening  38 . Ribs  32  are shown with flat face  34  positioned between these ribs. 
     With these designs, there can be multiple different embodiments with different thicknesses. For example, there is a first embodiment with a first thickness shown in  FIG. 9A  as embodiment  10 A. A lateral view of this embodiment is shown in  FIG. 9B . 
       FIG. 9C  is a view of a second embodiment of an implant  10   b  of a second thickness with  FIG. 9D  being an anterior view. 
       FIG. 9E  is an anterior view of another embodiment  10   c  which shows another embodiment with  FIG. 9F  showing a lateral view of this embodiment  10   c.    
       FIG. 9G  is an anterior view of the embodiment  10   d  with  FIG. 9H  being a lateral view of this embodiment. 
       FIG. 9I  is an anterior view of another embodiment  10   e  with  FIG. 9J  being a lateral view of this embodiment. 
       FIG. 10A  is an anterior view of another embodiment  10   k , with  FIG. 10B  being a lateral view of this embodiment. 
       FIG. 10C  is an anterior side view of another embodiment  10   m  with  FIG. 10D  being a lateral view. 
       FIG. 10E  is an anterior view of another embodiment  10   o  with  FIG. 10F  being a lateral view. 
       FIG. 11A  is a lateral view of a 3D image with the lattice screen in a first orientation showing the lattice screen  51  disposed inside of the frame  12 . 
       FIG. 11B  is a lateral view of the 3D image with the lattice screen rotated to provide greater visualization of bone growth with this view lattice  151  is shown having much less opacity and more openings to view bone growth inside of the lattice screen. 
     Thus, after surgery, and after a period wherein there is a time for additional bone growth, a doctor can examine the extent of bone growth inside of the lattice via examination through either an X-ray, an MRI, Cat Scan or other visualization technique. Depending on the angle and orientation of the picture taken by one of these machines, the orientation of the lattice screen can be utilized to expose the extent of bone growth in the lattice. 
       FIG. 12A  is a front right perspective view of a 3D image with the lattice  151  orientated to show greater bone growth inside of frame  12 . 
       FIG. 12B  is a perspective view with the lattice  51  orientated in a view to show less bone growth through window or opening  38 . This view shows struts  14 ,  16 ,  18  and  19  as well as core  20  as well. While a perspective view is shown, the most important view is from a side such as from the side views shown in  FIGS. 11 and 12 . In these lateral views a surgeon can determine optically through visual examination via either an X-ray, MRI scan or via a CAT scan the results of the bone growth in the lattice. 
       FIG. 13A  is a side perspective view of a lattice structure  50  which includes a honeycomb 3-D pattern for different cells. A single two-dimensional cell can be in the form of a hexagonal shaped cell, however a three-dimension shell as shown in  FIG. 13B  as cell  501  includes a plurality of struts  502 ,  503 ,  508  which can form a face such as face  507 . In addition, there is a core center region  505 , as well as a distance across a face  504  which can be varied based upon the varying density of the lattice structure. 
       FIG. 14A  is a view of a density profile of a first embodiment wherein the outer regions of the lattice such as lattice  50  are more dense than an inner region of the lattice structure which is interior to the external surfaces of the frame such as frame  12 . The lower density of the central or inner regions of the lattice structure allow for greater insertion of bone growth material as well as providing greater room for bone growth.  FIG. 14B  shows an opposite profile with the density being lower at the exterior portions of the lattice such as towards the exterior portions of the frame. 
       FIG. 15  is a flow chart of the process for rotating the lattice screen to provide an optimal image to show bone growth before printing the implant. For example, the process starts in step S 1  wherein the user determines the size and shape of the implant frame. Next, the process involves determining the size of the implant lattice to fit inside of the implant frame. In at least one embodiment, the size of the implant lattice is determined to extend beyond the frame. The extension of the lattice such as lattice  51  or lattice  151  is at least partially beyond the frame to create greater interaction between bones and the lattice. The gaps in the lattice therefore allow for greater bone growth between the interstices in the lattice. In at least one embodiment, the extension of the lattice is at least 3 millimeters beyond the extension of the frame. In another embodiment the extension of the lattice is less than three millimeters such as two millimeters. In another embodiment the extension of the lattice is more than three millimeters such as four millimeters or five millimeters. 
     Next, in step S 3  the user can determine the orientation and positioning of the implant in the body. For example, if the implant was to be positioned between two vertebrae in the body such as between C3 and C4 in the cervical spine, the frame would be if a first size. However, if the implant was to be positioned between two other vertebrae, such as between C4 and C5, then the thickness and size of the frame such as frame  12  would be different. These different sizes are shown in  FIGS. 9A-10F . 
     Next, once the orientation of the implant is determined, the user using this system would then determine a first orientation of the lattice such as lattice  51  inside of the frame. Next, in step S 5  the system could theoretically form the implant with the frame such as frame  12  being formed along with lattice such as lattice  51 . Next, in step S 6  the system could determine the opacity of the lattice at a first orientation. The system in step S 7  would then model the design to determine the opacity of the lattice at a second orientation. Next, in step S 8 , the system would determine which orientation results in less or lower opacity. Next, in step S 9  the system selects the orientation of the lattice which provides lower opacity. Steps S 6 -S 9  can be repeated in a cycle until a desired level of opacity of the lattice is achieved. Next in step S 10  the system records the orientation with lower opacity for printing. 
     Ultimately there is shown an implant for a spine such as a cervical, thoracic or lumbar spine section which can be implanted into the spine with an optimal level of opacity in the lattice to allow for greater visualization of the bone growth within a lattice. 
     Accordingly, while at least one embodiment of the present invention has been shown and described, it is to be understood that many changes and modifications may be made thereunto without departing from the spirit and scope of the invention as defined in the appended claims.