Abstract:
Disclosed is a device that is configured to be implanted adjacent interspinous processes of a patient. In one aspect, a spinal implant device comprises: a spacer region adapted to be positioned between first and second spinous processes of first and second vertebral bodies to limit movement of the first spinous process and the second spinous process toward one another; and an attachment region attached to the spacer region, the attachment region adapted to attach to the first spinous process via a fastener, the attachment region comprising a pair of pads having attachment elements that are configured to attach onto the spinous process.

Description:
REFERENCE TO PRIORITY DOCUMENTS 
     This application is a continuation of U.S. patent application Ser. No. 13/526,277, filed Jun. 18, 2012, which claims priority of U.S. Provisional Patent Application Ser. No. 61/515,541 entitled EXPANDABLE INTERSPINOUS DEVICE and filed on Aug. 5, 2011, and U.S. Provisional Patent Application Ser. No. 61/498,354 entitled EXPANDABLE INTERSPINOUS DEVICE and filed on Jun. 17, 2011. The disclosures of the Provisional Patent Applications are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND 
     Many people suffer from back pain due to any of a variety of factors. Such back pain can sometime be treated by introducing interspinous implants between the spinous processes of adjacent vertebral bodies in a patient&#39;s spine. This can maintain the stability of the vertebral column to increase the size of the spinal canal and allow the patient to have normal mobility. 
     There currently is a need for improved device that can be implanted between spinous processes. 
     SUMMARY 
     Disclosed is a device that is configured to be implanted adjacent interspinous processes of a patient. In one aspect, a spinal implant device comprises: a spacer region adapted to be positioned between first and second spinous processes of first and second vertebral bodies to limit movement of the first spinous process and the second spinous process toward one another; and an attachment region attached to the spacer region, the attachment region adapted to attach to the first spinous process via a fastener, the attachment region comprising a pair of pads having attachment elements that are configured to attach onto the spinous process. 
     Other features and advantages should be apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a perspective view of a device that is configured for placement between the spinous processes of two adjacent vertebral bodies. 
         FIG. 2  shows an enlarged, perspective view of the device of  FIG. 1 . 
         FIG. 3  shows a side view of the device of  FIG. 1 . 
         FIG. 4  shows the device positioned between a pair of spinous processes. 
         FIGS. 5-6  show another embodiment of an interspinous device. 
         FIGS. 6-10A  show another embodiment of an interspinous device. 
         FIGS. 10B-11  show another embodiment of an interspinous device. 
         FIG. 12  shows another embodiment of an interspinous device. 
         FIG. 13  shows another embodiment of an interspinous device. 
     
    
    
     DETAILED DESCRIPTION 
     Before the present subject matter is further described, it is to be understood that this subject matter described herein is not limited to particular embodiments described, as such may of course vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. Unless defined otherwise, all technical terms used herein have the same meaning as commonly understood by one skilled in the art to which this subject matter belongs. 
     As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope of the subject matter described herein. Any recited method can be carried out in the order of events recited or in any other order which is logically possible. 
       FIG. 1  shows a perspective view of a device  105  that is configured for placement between the spinous processes SP 1  and SP 2  of two adjacent vertebral bodies.  FIG. 2  shows an enlarged, perspective view of the device  105  and  FIG. 3  shows a side view of the device  105 . The device  105  includes a spacer or central region  205  that is sized and shaped to fit between the spinous processes of the two adjacent vertebral bodies. The device  105  further includes a pair of protrusions  210  that extend outward from the central region. The protrusions are size and shaped to couple to the spinous processes, as described more fully below. 
     With reference to  FIGS. 2 and 3 , the central region  205  comprises a cylindrical body having one or more openings that extend through the walls of the body. In the illustrated embodiment, the central region  205  is cylindrical and substantially circular when viewed from the side (as shown in  FIG. 3 ). A central shaft  305  extends through the central region  205 . Along an upper portion of the central region  205 , an elongated gap  208  is formed, which is sized and shaped to receive a locking member  215 , as described below. It should be appreciated that the central region  205  can have other shapes. 
     With reference still to  FIGS. 2 and 3 , the protrusions  210  comprise outwardly extending bodies or tabs. A pair of such protrusions extends outwardly from the central region  205  on each side of the gap  208 . A space between each of the protrusions is sized and shaped to receive at least a portion of a spinous process. For example, as shown in  FIG. 1 , the protrusions  210   a  and  210   b  define a space therebetween that is sized and shaped to receive the spinous process SP 1 . In this manner, the device  105  can be positioned between the spinous processes SP 1  and SP 2  with the protrusions  210  coupling to respective spinous processes to thereby serve anchoring or stabilizing functions. 
     As shown in  FIGS. 2 and 3 , the locking member  215  is sized and shaped to fit within the elongated gap  215 . In this regard, as shown in  FIG. 3 , the elongated gap  215  forms a pair of slots that are sized and shaped to receive complementary-shaped tabs on the locking member  215 . This permits the locking member  215  to be slidably positioned into the gap  215  by properly aligning the locking member adjacent the gap  215  and then sliding the locking member into the gap along a vector that would be normal to the plane of  FIG. 3 . After the locking member is positioned in the gap  215 , locking member may be rotated to cause a cam portion of the locking member to outwardly separate the central region along opposite sides of the gap  215  and thereby lock the central region onto the spinous processes. 
     This is described in more detail with reference to  FIG. 4 , which shows the central region  205  of the device  105  positioned between a pair of spinous processes SP 1  and SP 2 . At this stage, the locking member  215  is not coupled to the central region  205 . The locking member  215  can now be slid into the central region and rotated to cause the cam to expand the central region such that it exerts a force onto the spinous processes and fixes thereto. Note that a series of slots  220  ( FIG. 2 ) are located along the wall of the central region  205 . The slots are sized and shaped to receive at least a portion of a spinous process when the device  105  is implanted. 
       FIG. 5  shows another embodiment of the ISP device, referred to as device  505 . The device  505  includes four members including a first member  510 , second member  515 , third member  520 , and fourth member  525 . Each of the second, third, and fourth member has a central shaft or opening that is sized and shaped to receive an elongated shank  530  such that the members may be coupled to one another by inserting the shank  530  through the central openings of the other members. The fourth member  525  serves as a cap with internal threads that couple to external threads on the shank  530 . In this manner, the fourth member  525  can be secured to the shank  530  with the second and third members  515  and  520  secured along the shank  530  between the fourth member  525  and an enlarged head  535  of the first member  510 . 
     With reference still to  FIG. 5 , the second member  515  and third member  520  may be positioned with a space S therebetween. Each of the second member and third member are sized and shaped to be positioned adjacent or juxtaposed with a spinous process of a respective vertebra. The spinous process can be positioned within the space S and the second and third members tightened about the spinous process. The cap of the fourth member can then be tightened to secure the spinous process within the space S. 
       FIG. 6  shows another embodiment of the ISP device, referred to as device  605 . The device  605  includes a main body  610  that is sized and shaped to be positioned within the space between a pair of spinous processes. The main body may be coupled to an expander member  615  that threadably inserts into an opening  625  in the main body  610 . 
     The main body  610  has a substantially tubular configuration with an internal shaft and an out wall that forms a substantially cylindrical shape. A plurality of openings extend through the outer wall and communicate with the internal shaft. 
     The expander member  615  is elongated in shape and has a threaded shank that fits into the opening  625  of the main body. The expander member  615  can be rotated to engage with threads inside the opening  625  to engage the expander member  615  with the main body  610 . 
     Any of the device embodiments can be made of any biologically adaptable or compatible materials such as Polyether ether ketone (PEEK). Additional materials considered acceptable for biological implantation are well known and include, but are not limited to, stainless steel, titanium, tantalum, combination metallic alloys, various plastics, resins, ceramics, biologically absorbable materials and the like. In addition, any of the devices may be packed with a bone graft or other suitable material for fusing to adjacent bone. 
       FIGS. 7 and 8  show another embodiment of a device  705  that is configured for placement between the spinous processes SP 1  and SP 2  of two adjacent vertebral bodies. The device  705  includes two pairs of arms including a first pair with first and second arms  710   a  and  710   b , as well as a second pair with third and fourth arms  710   c  and  710   d . The arms  710   a  and  710   b  in the first pair of arms are sized and shaped to grasp or otherwise couple to the spinous process SP 1 . Likewise, the arms  710   c  and  710   d  in the second pair of arms are sized and shaped to grasp or otherwise couple to the spinous process SP 2 . As described in detail below, the relative positions of the arms can be adjusted by rotating actuator  715 . 
     Rotation of the actuator  715  causes the arms in a respective pair to rotate about an axis of rotation of the actuator  715 . That is, the arms rotate about the axis in a scissor-like manner. This permits the arms to be opened up to a size that would accept a respective spinous process and then closed to a size that grasps the respective spinous process. In an embodiment, each arm has a flat inner surface with projections that are configured to increase a frictional hold with the spinous process to which the arm is coupled, as shown in  FIGS. 9 and 10 . 
       FIG. 9  shows a perspective view of the device  705  in an assembled state and  FIG. 10A  shows the device  705  in an exploded state. The device  705  includes a first arm member  905  that includes a pair of arms. A second arm member  910  includes another pair of arms. Each arm member includes a central shaft in which a coupler member  915  and a screw member  920  may be co-axially positioned. The screw member  920  couples to a cap  925  that is positioned on an opposite end of the screw member  920  to secure the device  705  in an assembled state. The coupler member  915  and screw member rotatably attach to the arm members  905  and  910 . When the screw member is rotated, it causes the arm members  905  and  910  to also rotate such that the arms may be rotated toward and away from another. 
       FIGS. 10B and 11  show another embodiment of the ISP device, referred to as device  1005 . The device  505  includes a pair of opposed members  1010  that define a space S therebetween. Each of the members  1005  is sized and shaped to be positioned adjacent or juxtaposed with a spinous process of a respective vertebra. The spinous process can be positioned within the space S. In this regard, each of the members  1010  includes one or more pads  1017  having attachment elements, such as spikes, that are configured to attach onto the spinous process. The pads are attached to the members in a ball and socket manner such that the pads are configured to rotate and pivot about the ball and socket attachment. 
     With reference still to  FIGS. 10B and 11 , a connector  1020  connects the two members  1010  to one another. The connector  1010  is an elongated shaft having a first end with a head  1025  that sits in a seat in one of the members  1010 . A second end region of the connector  1010  extends through a hole in the second member  1010 . The connector  1020  and hole may be threaded such that rotation of the connector  1010  causes the two members  1010  to move toward or away from one another depending on the direction of rotation. In this manner, the spinous process may be secured between the two members  1010 . An outer housing  1030  is positioned around the connector  1020 . The outer housing is sized and shaped to receive bone material for fusing with the spine. 
     In another embodiment, shown in  FIG. 12 , the device includes a pair of members  1005  and a connector  1010  therebetween. The connector is formed of a first connector member  1205  and a second connector member  1210  that coupled to one another such as in a male-female relationship. The connector members include a ratchet interface that permits the two connector members to be pushed toward one another in an interlocking fashion. The ratchet interface permits the two members  1005  to be successively moved toward one another and locked in successively closer positions so as to vary the size of the space S. The configuration of the ratchet can be varied to permit various increments of relative movement between the two members  1005 . 
     In yet another embodiment, shown in  FIG. 13 , the device includes a pair of members  1005  that are monolithically coupled to one another via a connector  1305  that is monolithically attached to the two members. A set of pads  1317  are positioned on the members wherein the pads  1317  include attachment elements such as spikes. The pads  1317  define a space therebetween that is sized to receive an interspinous process. The positions of at least some of the pads can be moveably adjusted to vary the size of the space S between facing pads. 
     Although embodiments of various methods and devices are described herein in detail with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.