Abstract:
Described here are delivery or fastener device fixation implant devices, delivery instrumentation, and methods for using them. In particular, the description relates to implants having a having a strength sufficient to support, anchor, secure, maintain, or to otherwise repair an elongated delivery or fastener device anywhere such a device, such as, for example, a bone screw, may need further securing within a substrate it is inserted into, such as, for example, within human or animal tissue, such as bone tissue.

Description:
REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of the filing date of U.S. Provisional Application No. 61/518,611, filed May 8, 2011, the entirety of which is incorporated herein by reference. 
     
    
     FIELD 
       [0002]    Described here are delivery or fastener device fixation implant devices, delivery instrumentation, and methods for using them. In particular, the description relates to implants having a having a strength sufficient to support, anchor, secure, maintain, or to otherwise repair an elongated delivery or fastener device anywhere such a device, such as, for example, a bone screw, may need further securing within a substrate it is inserted into, such as, for example, within human or animal tissue, such as bone tissue. Also described are instrumentation devices for delivering fastener fixation devices into a desired location. Also, methods are described for inserting these implants into desired locations for repairing or anchoring fasteners, such as, for example, tissue fasteners such as bone screws. 
       BACKGROUND 
       [0003]    The present invention as disclosed herein provides implant devices, delivery instruments and methods for their use for securing delivery or fastener devices within a substrate or tissue that the device is inserted into, such as, for example, a bone screw inserted into cortical or cancellous bone. Currently, delivery or fastener devices, such as, for example, drainage tubes, delivery cannulas, screws, bolts or other devices are limited in their ability to provide long lasting load bearing capabilities due to a multitude of factors, such as, for example, the deterioration of substrate or bone tissue, that cause traditional delivery or fastener devices to loosen over time. Typically when these devices loosen they must be removed and replaced with a larger device to maintain the desired load bearing capabilities. It would be advantageous to provide a device that could provide anchoring, repairing and/or stabilization of a fastener device without replacing the delivery device or fastener. U.S. patent application Ser. No. 10/866,219, Ser. No. 11/298,961, and Ser. No. 12/616,843 by Zwirkoski disclose fixation devices comprised of flexibility connected segments having sufficient strength to anchor, support and/or repair delivery or fastener devices such as, for example, a bone screw. However, these patent applications do not disclose the novel embodiments and methods of use disclosed in the instant invention. 
       BRIEF SUMMARY 
       [0004]    Broadly, described here are various devices, such as guide rings, for securing fixation implants in precise desired locations delivery or fastener devices within a substrate cavity, non-flexibly connected segmented implants for securing fasteners within a cavity space, helical implants, instrumentation for the delivery of fastener fixation devices, and methods of using these devices to anchor, secure and/or repair a delivery device or fastener. Generally, fastener fixation implants, some of which are described herein and elsewhere, can be arranged and delivered into fastener space in a controlled and measured way through the use of structural implant guide rings or related implants. In addition, fastener fixation delivery devices are described that allow for the precise placement of the implants and guide rings. 
         [0005]    Methods are described herein for using various guide components and instrumentation to achieve optimal placement and anchoring strength for fastener fixation implants. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]    Embodiments or variations are now described by way of example with reference to the accompanying drawing. 
           [0007]      FIG. 1  shows an embodiment of an elongated fixation device surrounded by a fixation implant with a proximal and distal fixation implant guide ring. 
           [0008]      FIGS. 2   a - b  show various perspectives of a proximal fixation implant guide ring. 
           [0009]      FIGS. 3   a - b  show various perspectives of a proximal fixation implant guide ring with locking tabs. 
           [0010]      FIGS. 4   a - c  shows various perspectives of a proximal fixation implant guide ring with a recessed locking component. 
           [0011]      FIGS. 5   a - e  show various perspectives of an alternative embodiment of a proximal fixation implant guide ring with a recessed locking component. 
           [0012]      FIGS. 6   a - b  show various perspectives of an alternative proximal fixation implant guide ring. 
           [0013]      FIGS. 7   a - c  show various perspectives of a distal fixation implant guide ring. 
           [0014]      FIGS. 8   a - b  show various perspectives of an alternative embodiment of a distal fixation implant guide ring. 
           [0015]      FIGS. 9   a - d  show various perspectives of an alternative embodiment of an expandable helical designed fixation implant guide ring. 
           [0016]      FIG. 10  shows a bone screw fastener with a proximal and distal fixation implant guide ring. 
           [0017]      FIGS. 11   a - b  show two perspectives of a fixation segmented implant attached to a distal fixation implant guide ring. 
           [0018]      FIGS. 12   a - c  show various perspectives of segmented fixation implants connected to distal and proximal fixation implant guide rings. 
           [0019]      FIGS. 13   a - b  show various perspectives of an alternative embodiment of segmented fixation implants with multiple fixation implant guide rings. 
           [0020]      FIGS. 14   a -d show an alternative embodiment of segmented fixation implants with a partial fixation implant guide ring design. 
           [0021]      FIG. 15  shows a perspective of an alternative zigzagged embodiment of a segmented fixation implant. 
           [0022]      FIG. 16  shows an alternative perspective of an alternative crisscrossed embodiment of a segmented fixation implant. 
           [0023]      FIG. 17  shows a perspective of an alternative sinualsodial shaped segmented fixation implant embodiment. 
           [0024]      FIG. 18  a perspective of an alternative embodiment of a segmented fixation implant with overlapping sinualsodial shaped. 
           [0025]      FIGS. 19   a - b  show various perspectives of a helical shaped fixation implant. 
           [0026]      FIGS. 20   a - b  show various perspectives of an alternative embodiment of a helical shaped fixation implant with a tighter wind. 
           [0027]      FIG. 21  shows a perspective of a helical shaped fixation implant on a bone screw. 
           [0028]      FIG. 22  shows a helical shaped fixation device with the proximal and distal ends larger than the center. 
           [0029]      FIG. 23  shows various perspectives of a guided fixation implant delivery device with slots. 
           [0030]      FIG. 24  shows various perspectives of a guided fixation implant delivery device with proximal and distal guide rings. 
           [0031]      FIG. 25  shows various perspectives of a guided fixation implant delivery cannula with an alternative embodiment of proximal and distal guide rings. 
           [0032]      FIG. 26  s a delivery cannula with alternative implant guide rings. 
           [0033]      FIGS. 27   a - b  show a delivery cannula with an alternative implant guide ring. 
           [0034]      FIGS. 28   a - b  show various perspectives of a fixation implant delivery driver. 
           [0035]      FIGS. 29   a - b  show various perspectives of an alternative fixation implant delivery driver. 
           [0036]      FIGS. 30   a - d  show various perspectives of a fixation implant delivery portal stabilizer. 
           [0037]      FIGS. 31   a - b  show perspectives of various guided fixation implant delivery components. 
           [0038]      FIGS. 32   a - b  show two perspectives of fixation implant delivery device components. 
           [0039]      FIG. 33  shows a delivery tamp. 
           [0040]      FIGS. 34   a - d  show various positions of the delivered guided fixation device and implants. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    The fixation devices described herein are utilized with substrate delivery or fastener devices within a substrate, such as, for example, human tissue fastener devices such as, for example, a bone screw. The fixation implant support systems, delivery devices, and methods described herein are utilized with fixation implants for use with delivery devices or fasteners, particularly bone fasteners. While human tissue, such as bone is utilized as an example, any substrate could be utilized such as, for example wood, cement, drywall, or anywhere a delivery device or fastener needs fixation or securing. 
         [0042]    Fixation Implant Guides 
         [0043]    In one preferred embodiment as shown in  FIG. 1  a fastener such as for example a bone screw  101  is encased with multiple flexibly connected segmented fastener fixation implants  103  that are placed around the fastener  101  with connections to a distal implant guide ring  105  and a proximal implant guide ring  107 . These implant guide rings provide control and stability for the delivery and placement of the fastener fixation implants  103  in a desired location.  FIGS. 2   a - b  show a top  201  and side  203  view of an example of a proximal implant guide ring  107  with openings  205  for placing the fastener fixation implants  103 . In  FIG. 2   a  six fastener fixation implant openings are utilized. Any number of fastener fixation implants  103  and corresponding openings  205  might be utilized however depending on the desired result. 
         [0044]      FIGS. 3   a - b  show various perspectives of a proximal implant guide ring  107 .  FIG. 3   a  includes a penetrating locking tab  301  which can penetrate into the substrate, such as, for example, bone surrounding a delivery device or fastener such as a bone screw  101  and prevent rotation of the guide ring  107  once placed. One or more of the penetrating tabs  301  might be utilized to secure the guide ring.  FIG. 3   b  shows a proximal implant guide ring with a penetrating locking tab  301  and a parallel flexible locking tab  303  that can be flexed into a position on a fastener  101  providing pressure on the fastener to prevent rotation of the proximal implant guide ring  107 . 
         [0045]      FIGS. 4   a - c  show a proximal implant guide ring  107  with a distal portion  401  that enters a fastener pathway into a substrate such as bone and positions the proximal implant guide  107  into the desired position without slippage. The proximal portion of the implant guide ring  403  might abut the proximal opening of the fastener opening  404 . The distal portion might be layered and narrowed inwardly  405  at the distal portion  401  of the implant guide ring  107  as shown in  FIGS. 4   b - c.    
         [0046]    In one embodiment as shown in  FIGS. 5   a - e  the distal sides of the proximal top of the proximal implant guide ring  107  might include gripping components such as scalloped spline teeth  501  that would help lock the guide  107  into the substrate such as bone surrounding the fastener opening. In one alternative embodiment the teeth might be located on the sides of the distal portion  503  of the proximal guide ring  401  as shown in  FIG. 5   d . While the preferred embodiment might include teeth and gripping component that might prevent rotation or movement of the proximal implant guide ring  107  any locking mechanism might be utilized. The distal portion  401  of the proximal implant guide ring  107  might contain spacings  505  that allow for the distal portion of the proximal guide ring  107  to be contracted and inserted into a fastener opening and upon placement expand out to secure the proximal guide ring  107 .  FIGS. 6   a - b  show an alternative shape for a proximal implant guide ring  107  whereby the inner wall  603  of the proximal guide ring  107  might have an irregular shape with flexible tabs  605  to assist with placement. In this embodiment the fastener  101  when placed into the guide ring would push the tabs  605  distally  607  between the proximal fastener head  609  and the substrate below the head  611 , such as bone, providing a locking pressure on the proximal implant guide ring  107  preventing it from rotating or moving. 
         [0047]      FIGS. 7   a - c  show various perspectives of one embodiment of a distal fixation implant guide ring  105 . In this embodiment the fastener fixation implants  103  would be placed through the openings  701  allowing for desired placement of the fastener fixation implants along the length of the fastener  101 . In one embodiment the distal end  703  of the distal guide ring  105  is tapered for placement at the bottom of the fastener  101  opening to provide self centering of the distal implant guide ring  105 .  FIGS. 8   a - b  show an alternative embodiment of a distal implant guide ring  105  without a self centering feature. In this embodiment the distal implant guide ring might include a tapered opening  801  that narrows distally  803  within the distal guide ring  105 .  FIGS. 9   a - b  show a helical shaped spring form expandable guide ring  901  of an implant guide ring  105  to facilitate securing the implant guide ring  105  and delivery device or fastener fixation implants  103 . The distal end of the delivery device or fastener  101  pushes the distal implant guide ring  105  outwardly once placed. 
         [0048]      FIG. 10  shows a fastener  101  with a distal guide ring  105  and a proximal guide ring  107 .  FIGS. 11   a - b  show a helical segmented fixation implant  1101  connected to a distal implant guide ring  105 .  FIGS. 12   a - c  show a fixation implant  103  surrounding a fastener  101  and guided by a proximal implant guide ring  107  without a distal guide ring where the fixation implants  103  are not connected at all at their distal ends.  FIGS. 13   a - b  show an alternative embodiment that includes three or more implant guide rings that include a distal ring  105 , a proximal ring  107  and one or more implant guide rings  1301  located between the distal  105  and proximal implant guide rings  107  which might further stabilize and control the placement of the fixation implants  103 . Any number of additional implant guide rings  1301  could be utilized. 
         [0049]    In  FIGS. 14   a - c  an alternative embodiment is shown where the segments  1401  of the fastener fixation implant  1403  are larger and act as partial implant guide rings that share two or more common connector strands  1407 . In the disclosed embodiment the enlarged segment shapes  1401  are shown as two half circles  1409  with three connector strands  1407  passing through each segment. Any number of segments  1401  and/or connector strands  1407  could be utilized however that are able to achieve stabilization of the fastener fixation implants  103  around a fastener  101 . 
       Non-Flexible Connecting Fixation Implants 
       [0050]    Prior disclosures of fastener fixation implant  103  designs disclose flexibly connected segments that allow for random placements of the implants.  FIGS. 15-18  show example embodiments of non-flexibly connected segmented implants wherein the connecting materials are rigid and shaped to surround a delivery device or fastener so as to be fixated in position.  FIG. 15  shows an alternative embodiment disclosing a zigzag fastener fixation implant design  1501 . With this design the implant segments  1503  are connected by rigid connectors  1505  that form a back and forth zigzag shaped fastener fixation implant that would surround a fixation device  101 . One or more implant strands  1505  might be utilized with each fastener  101  depending on the fixation desired. In one alternative two or more connector strands might by connected to form a crisscross fastener fixation implant  1601  as shown in  FIG. 16 .  FIG. 17  discloses a sinualsodial wave form fastener fixation implant design  1701 .  FIG. 18  shows an implant design with two connected strands  1803  intertwined to allow for two or more sinualsodial wave forms  1801 . 
         [0051]      FIGS. 19   a - b  and  20   a - b  show variations of a helical fixation implant  1901  that contain no segments and wrap around a delivery device or fastener, such as, for example,  101  as shown in  FIG. 21 .  FIG. 20  shows a tighter bound helical fixation implant  2001 .  FIG. 22  shows a helical fastener fixation implant  1901  where the thickness of the fixation implant is greater at the distal  2201  and proximal  2203  ends of the helical fastener fixation implant  1901 . 
       Fixation Implant Delivery Devices 
       [0052]    To facilitate the delivery of fastener fixation implants into a fastener opening in a controlled manner in order to achieve desired placement disclosed herein are various delivery components. In  FIG. 23  a delivery portal cannula  2301  is shown. The delivery portal cannula  2301  consists of a cannula that narrows towards its distal end  2302 . The distal end of the implant delivery portal cannula is inserted into the delivery device or fastener cavity space  2402 . The delivery portal cannula  2301  has one or more slots  2303  that allow for expansion of the distal portion of the delivery portal cannula  2302  within the cavity space  2402 . The fastener fixation implant with its implant guide rings is delivered into the cavity space through the delivery portal cannula  2301 .  FIGS. 24-26  show various fixation implant guide rings  105  and  107  located at the proximal and distal end of the portal. The segmented implants would be connected between the proximal  107  and distal  105  implant guide rings as shown in  FIGS. 34   a - d.    
         [0053]    The implant guide rings are placed into the delivery portal cannula and delivered into the delivery device or fastener cavity with the use of a fixation implant delivery driver disclosed in  FIGS. 28   a - b.  In the preferred embodiment the fixation implant delivery driver  2801  would consist of a handle grip  2803 , a centralized body  2805 , and narrow probe component  2807  and a driver tip  2809 . In one embodiment the distal end  2810  of the driver tip  2809  is tapered to fit within a delivery portal cannula  2301 . At the distal end of the driver tip  2807  the tip might be circumvental  2811  to allow for tamping of the placed fixation implant upon withdrawal after placements. In an alternative embodiment the delivery tip might be thin  2901  and tapered  2903  as shown in  FIGS. 29   a - b.    FIG. 33  discloses a tamp  3301  that might be utilized after the guide rings and implants are delivered and placed in the desired location within the cavity. The tamp  3301  would facilitate the securing of the implant to the inner wall of the delivery device or fastener cavity. 
         [0054]    In one embodiment a delivery portal cannula stabilizer  3001  might be utilized as shown in  FIGS. 30   a - d  and  31   a - b.  In this embodiment the stabilizer might be oblong  3002  and contain an access portal  3003  to allow for the delivery portal cannula  2301  and the fixation implant delivery device  2801 . It could be of any shape that would provide stabilization of the delivery portal cannula.  FIGS. 31   a  and  b  show the stabilizer  3001  placed on the outside of soft  3101  tissue with the delivery portal cannula  2301  and fixation implant delivery device  2801  passing through the access portal  3003 . The distal end of the delivery portal cannula  2303  passes down into the fastener space  2302 . The fixation implant delivery device tip  2809  then drives the distal implant guide ring  105  to the distal end of the fastener space  2302  placing the fixation implant  103  (not shown) in its desired location within the fastener space  2302 . Upon withdrawal of the fixation implant delivery device  2801  the delivery tip  2809  disclosed in  FIGS. 28   a -see might tamp the implant  103  segments into the inner substrate  3107  wall, such as bone wall of the fastener space,  2302  further securing the implant  103 .  FIG. 32  shows a different perspective of the delivery portal cannula and delivery device components. 
         [0055]    It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the described device as specifically shown here without departing from the spirit or scope of that broader disclosure. The various examples are, therefore, to be considered in all respects as illustrative and not restrictive.