Abstract:
A closure for use with an open headed medical implant with a pair of inwardly threaded arms. The closure is bow-tie-shaped having a pair of opposed cylindrical sections that have outwardly threaded surfaces that are discontinuous therebetween. The cylindrical surfaces are joined by walls having outer curved surfaces each having a radius that is less than a radius associated with the cylindrical surfaces. The closure also has a central bore receiving a set screw in use. Tools for installing the closure include a tool with a head having a channel receiving the closure and wings on opposite sides of the channel that have outer surfaces that are threaded so as to compliment and complete the threads on the outside of the closure, when the tool is thereon, so as to provide a substantially continuous circumferential thread for installation. A group of removal tools includes a first tool having a head that fits over the closure and includes a pair of wings with outer cam surfaces thereon for operably wedging apart the implant arms and a second non-threaded tool for turning the closure once the arms are wedged apart.

Description:
BACKGROUND OF THE INVENTION 
     The present invention is directed to a closure for use in conjunction with open ended medical implants, such as bone screws, hooks and the like that are used in certain types of spinal surgery. The purpose for the closure is to capture a rod member within the head of the implant and to also lock the captured rod member in position relative to the implant so that the two do not move rotationally or axially with respect to one another. 
     Medical implants such as bone screws and hooks are used in many types of spinal surgery wherein a structure is built about and within the spine to provide support or strength to diseased, missing or damaged spinal elements of the patient. The implanted apparatus includes a number of different parts which vary with each patient and that are linked together to form a stable support system. For example, bone screws are typically threadably mounted in the bones and have heads that receive rods or similarly shaped connectors that join other bone screws or other elements of the system together. Bone screws of this type may have either closed heads wherein a rod is threaded into the head from the side or an open head wherein a rod is laid in a channel formed in the head. The later type of bone screws are referred to as open ended bone screws. Such open ended bone screws are favored in many types of spinal surgery, since a rod does not have to be threaded through the bone screw which is difficult to do in the tight space provided and because the spine curves making insertion of a rod that follows the spinal curvature very difficult. On the other hand, the open ended bone screws allow the rod to be laid or drawn into the open channel of the head which greatly simplifies installation in comparison to threading the rod through a head of the bone screw. 
     While open ended medical implants such as bone screws, hooks and the like are often easier to use in comparison to closed end implants of the same type, the open ended implants do have associated problems. In particular, in open headed implant systems it is extremely important that there be no slippage or relative movement between the connecting rods and the implants, such as bone screws, to which the rods are joined. The rods in this case are usually not linear, but are curved to follow the curvature of the spine. If the rod is allowed to slip either axially or rotate within the bone screw or other connector to which the rod is secured, at a minimum the effectiveness of the implant is decreased and it is possible that the patient could be severely injured. Consequently, it is extremely important to secure the rod to the bone screw or other connector so that no slippage occurs. In some of the prior art devices, open headed implants, which typically have a pair of spaced arms, have been internally threaded and have received a threaded plug between the arms, which plug is designed to abut against the rod under torque and both capture the rod in the head and lock the rod into place. 
     The plug of the prior art has an outer cylindrical surface that is threaded and is received in the threads of the arms. In order to do this the plug has a comparatively large diameter so that the plug extends out sideways relative to the bone screw or the like or the bone screw must be made wider than necessary. That is, the plug makes the overall implant wider than is necessary. This presents problems to the surgeon installing the system, as space is very limited along the rods in many situations and there is not enough room for all of the total system structure to attach to the rods or, if there is sufficient room for attachment of elements, then there may be insufficient room for the surgeon to manipulate the rod by use of benders to shape the rod to conform to the proper spinal curvature, as is required in many of the surgeries using these devices. It is also noted that other prior art devices have a ring that goes around the outside of the arms. Such a ring is very bulky, taking up a great amount of space along the rods to which the implant is joined. Consequently, it is very desirable to eliminate this side to side extension of the closure along the axis of the rod. That is, it is desirable that the implant and closure both have a low side to side profile. 
     Secondly, as has been mentioned above, the rods are typically bent throughout the length thereof, such that the rods follow the curvature of the spine. Because of this, the rods seat in the open head of the bone screws and other implants in such a manner that the rod has curvature associated with it, even within the head. When plugs of the prior art seat against the rod, typically the rod is bowed so that the rod engages the plug only at the radially outer edges thereof on both sides. The plug is then torqued against the rod to tighten it down against the seat in the bone screw channel, but it is quite difficult to tighten the rod sufficiently so that the portion of the rod within the head has no curvature after tightening. Subsequently, during use of the device, the rod may be flexed or bent by activity of the person, especially greater activity than normal, such as occurs in an accident or the like, and the remaining curvature of the rod flexes somewhat, thereby loosening the plug. When this occurs, the rod may slip axially or rotate relative to the implant and/or the plug may become loosened and work out of the implant. Both of these situations are very undesirable. 
     Therefore, there is a need to provide a closure for bone screws and other medical implants having an open head such that the closure has both a relatively thin profile along the axis of the rod or the like and also where the closure has a mechanism whereby the rod can be locked centrally opposite the seat to prevent the rod from becoming loosened should the rod flex during usage. 
     Further, it is sometimes necessary to remove the bone screw closures after being installed. Because of the high torque applied to the closure and because of the relative smallness of the parts, it is often difficult to acquire sufficient purchase to rotate and remove the closure. Therefore, a removable closure and tools for removing the closures are also desired. 
     SUMMARY OF THE INVENTION 
     A closure is provided for use in conjunction with open headed medical implants, such as bone screws and hooks, which receive rods and other structure for interconnecting with various parts of an overall system. The closure is bow-tie-shaped with opposed cylindrical sectors that are radially outwardly threaded and that are joined by generally curved walls having a reduced radius in comparison to the cylindrical sectors. The threads on the cylindrical sectors are sized and shaped to mate with the threads on internal surfaces of arms of the implants. The closure also includes a central passthrough threaded bore that is coaxially located with respect to the closure. 
     A set screw having a base with a radially outwardly threaded surface and a head is threadably mounted in the bore during installation of the closure. The set screw includes a point that extends from the closure bore when fully installed so as to engage a rod member located in the head of the implant. The set screw may be of a break-off head variety or may retain its head after installation. Also the set screw may be designed to rotate with the closure during installation or independently of the closure. In one embodiment the set screw is designed to extend entirely through the bore of the closure during installation and engage a rod in an implant head under torque until the head of the set screw breaks away at a predetermined torque. In such an embodiment the closure functions to capture the rod in the head and the set screw functions to lock the rod in place relative to the head of the implant. 
     A set of tools is also provided for installation of the closure since the closure has discontinuous threads thereon. The installation tool includes a handle for rotating and a head that has a channel for receiving the closure. The head also has a pair of wings on either side of the channel which are radially outwardly threaded and positioned so as to mate with the closure such that the threads on the closure and the threads on the wings form a generally continuous thread that may be utilized advantageously to mount the closure in the head of the implant. A second tool including a shaft with a threaded tip may also be mounted in the bore of the closure during installation to allow the installer to better grip the closure. 
     A set of removal tools is also provided. A first removal tool includes a turning handle and a head that receives the closure. The head includes outer surfaces that are of non-uniform radius so as to present a cam surface that is operably wedged against the implant arms to inelastically spread the arms, and thereby loosen the closure. The second tool is similar, but with a head having wings that are uniform in radius and thickness and non-threaded that allow rotation of the closure in the implant after it is loosened. 
     OBJECTS AND ADVANTAGES OF THE INVENTION 
     Therefore, the objects of the present invention are: to provide an overall medical implant system wherein the system includes various bone screws, hooks and the like with open heads that are joined with a series of rod-like structures by use of a closure in accordance with the present invention; to provide such a closure which is relatively thin in profile along the axes of the rods with which it is utilized; to provide such a closure which is bow-tie-shaped and includes a pair of cylindrical sectors that are opposed to one another and which are externally threaded so that the closure is only partially threaded and such that the thread is discontinuous between the sectors, but in such a way as to threadably mate with threads on internal surfaces of arms of open headed implants; to provide such a closure which includes a central passthrough and threaded bore; to provide such a closure with such a bore in conjunction with a threaded set screw received in the bore and passing at least partially through the bore during installation; to provide such a closure wherein the closure captures a rod member within a head of an implant and wherein the set screw locks the rod member in place relative to the implant head to prevent rotation or axial relative movement of the rod member in relation to the head; to provide such a closure having a relatively thin profile upon installation; to provide a set of tools to be used in conjunction with installation of the closure; to provide such tools including a closure installation tool having a head that receives the closure and a pair of wings that extend outwardly on either side of the closure with threads on outer surfaces of the wings that compliment threads on the closure so as to provide, when joined, a generally continuous thread for use in installation of the closure; to provide removal tools, especially a tool that operably wedges apart implant arms to loosen a closure therein, to aid in removal in the closure should removal be necessary; to provide such an overall system and, especially, a closure that is relatively easy to use, economical to produce and especially well adapted for the intended usage thereof. 
     Other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. 
     The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of a closure in accordance with the present invention. 
     FIG. 2 is a top plan view of the closure. 
     FIG. 3 is an exploded side elevational view of a bone screw, the closure on a reduced scale and a pair of tools utilized in installation of the closure in the bone screw. 
     FIG. 4 is a perspective view of the closure and a fragmentary view of the closure installation tools just prior to joining together thereof. 
     FIG. 5 is a side elevational view of a medical implant system including the bone screw, a rod and the closure with the closure installing tools thereon and with the closure being installed in a head of the bone screw, with portions broken away to show detail thereof. 
     FIG. 6 is a fragmentary side elevational view of the bone screw mounted in a vertebra and with the closure capturing a rod therein and still further with a set screw being installed in the closure with a torquing tool. 
     FIG. 7 is a side elevational view of the bone screw, the rod and the closure of FIG. 6 with a head of the set screw separated from a base thereof subsequent to torquing of the set screw, and with portions broken away to show detail thereof. 
     FIG. 8 is a cross-sectional view of the implant, the rod, the closure and the base of the set screw, taken along line  8 — 8  of FIG.  7 . 
     FIG. 9 is a cross-sectional view of the vertebra, the bone screw, the rod, the closure and set screw, taken along line  9 — 9  of FIG.  8 . 
     FIG. 10 is a partially exploded perspective and fragmentary view of the bone screw, the rod, the closure and a first closure removal tool prior to installation on the closure. 
     FIG. 11 is a perspective view similar to FIG. 10 with the first closure removal tool positioned on the closure. 
     FIG. 12 is a cross-sectional view of the bone screw, the closure and the first closure removal tool just prior to use of the first closure tool. 
     FIG. 13 is a cross-sectional view of the bone screw, the closure and the first closure removal tool similar to FIG. 12 at the end of use of the first closure removal tool to spread arms of the bone screw, 
     FIG. 14 is a fragmentary perspective view of the bone screw, the closure and a second closure removal tool. 
     FIG. 15 is a cross-sectional view of the bone screw, the closure and the second closure removal tool, taken along line  15 — 15  of FIG.  14 . 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. 
     The reference numeral  1  generally indicates a closure in accordance with the present invention. The closure  1  is utilized in conjunction with a bone screw  6  that receives a rod  7  and is implanted in a vertebra  8  of a patient&#39;s spine. The closure  1  is locked with respect to the bone screw  6  by a set screw  9 . 
     The bone screw  6  is conventionally referred to as an open headed bone screw having a threaded shank  11  that is screwed into a patient&#39;s vertebra  8  and a head  12 . The bone screw head  12  is bifurcated with a pair of upstanding and spaced arms  14  and  15  forming a channel  16  therebetween with a seat  17  at the bottom of the channel  16 . 
     Radially inward and facing surfaces  20  and  21  of the arms  14  and  15  respectively are threaded with a thread that is discontinuous between the surfaces  20  and  21 . Use of the term discontinuous here means that the threads on the two surfaces  20  and  21  are substantially spaced from each other. The closure  1  of the present invention may be used in conjunction with any of a number of different types of open headed implants, including the illustrated bone screw  6 , hooks or the like which are conventionally used in spinal surgery. 
     The rod  7  is circular in cross section and elongate, although it is foreseen that rods of other cross section including square may be used with the invention. The rod  7  may also be smooth surfaced or knurled. The rod  7  illustrated in the figures is somewhat curved so as to be upwardly concave when viewed from the side, such as in FIG. 5 or  9 . Because the rod  7  is curved, it often does not lie flat in the seat  17 , but rather has a primary point of contact  23  that engages the seat  17 . In certain embodiments, the rod may engage the seat  17  at more than one location. It is also seen that in accordance with the present invention the closure  1  could be used in conjunction with other rod-like connector structures to maintain such structures in the head of the bone screw. 
     The closure  1  has a plug or body  26  that is bow tie-shaped when viewed from above or below having a pair of generally equal and opposed cylindrical sections  28  and  29  on either end thereof. Each of the cylindrical sectors  28  and  29  have radially outward surfaces  31  and  32  respectively that are threaded. The threads of the surfaces  31  and  32  are discontinuous with respect to one another with substantial spacing therebetween, such that there is no continuous thread associated with the exterior of the closure  1  itself which extends entirely about the closure  1 . In the illustrated embodiment the threads associated with each sector  28  and  29  extend approximately one quarter of the way around the closure  1 . 
     Joining the curved surfaces  31  and  32  are a pair of generally curved surfaces  34  and  35  that are formed by reducing the outer radius of the closure  1  in the region of the surfaces  34  and  35 . End walls  36  join the surfaces  34  and  35  with the surfaces  31  and  32 . The closure  1  also has a generally flat upper surface  37  and a flat lower surface  38  which are perpendicular with respect to an axis of rotation A of the closure  1 . The threads of the curved outward surfaces  31  and  32  are threadably mateable with the threads on the arm surfaces  20  and  21  respectively except that due to the discontinuities it is very difficult to do so without the assistance of the tool described below. 
     The closure  1  includes a central bore  47  that is coaxial with the axis A of rotation of the closure  1  and that is internally threaded. The bore  47  passes entirely through the closure  1  and extends between the upper surface  37  and lower surface  38 . 
     The set screw  9  has a base  51  and a head  52 . The base  51  has a radially outward surface  54  that is threaded so as to be mateable with the thread in the bore  47 . The base  51  also has a lower and outwardly projecting point  56  that during and after installation is coaxial with the axis A. The set screw base  51  and head  52  are joined by a break-away region  58 , such that the base  51  breaks away from the head  52 , when a predetermined torque is applied to the set screw  9 , such as is illustrated in FIG.  7 . The head  52  includes a grippable surface  61  having a number of polyhedrally arranged faces for gripping by a tool described below, here in a hexagon configuration. 
     A closure installation tool  66  and a closure holding tool  67  are provided for installing the closure  1 . The closure installation tool  66  includes a T-shaped handle  70  and a head  71 . A bore  72  runs through the interior of the handle  70  and head  71  for receiving the holding tool  67  and is sized to slidingly receive the holding tool  67  therein. 
     The head  71  includes a channel  74  sized and shaped to snugly receive the closure  1 . FIG. 4 shows the closure  1  just prior to being received in the tool head  71  and FIG. 5 shows the closure  1  received in the tool channel  74 . The head  71  also includes a pair of wings  75  and  76  that are positioned on opposite sides of the channel  74 . The wings  75  and  76  are formed as fragments of an externally threaded cylindrical ring having a uniform thickness that is equal in width to the difference between the radius of the closure outer curved surfaces  31  and  32  and the closure inner curved surfaces  34  and  35 . The wings  75  and  76  also have the same arc as the surfaces  34  and  35  so as to fit snugly therewith and extend generally along the length thereof when mated. 
     An outer surface  78  and  79  of each wing respectively is threaded and the wings  75  and  76  are sized and shaped such that the threads on the surfaces  78  and  79  compliment and generally complete the threads on the closure surfaces  31  and  32 , so that the threads on the radially outward portions of the closure  1  are thereby completed and made generally sufficiently continuous by installation of the closure installation tool  66  on the closure  1  to mount the closure  1  in the head  12 . In this manner the closure  1  can be easily screwed into the bone screw head  12  between the arms  14  and  15 . 
     The closure  1  and the installation tool  66  may include markings or structural elements to insure that the closure  1  is properly aligned with the tool  66  and that the threads of the tool  66  are positioned on the correct sides of the closure  1 , since the threads on opposite sides are not interchangeable. 
     The holding tool  67  includes a shank  86  joined to a threaded tip  87  at a shoulder  89  and a turning knob  88  opposite the tip  87 . The tip  87  is sized and shaped to be threadably received in the closure bore  47 . In particular, the holding tool  67  is slidably inserted through the closure installation tool bore  72 , as is seen in FIG.  4  and secured to the closure  1 , so as to hold the closure  1  in the closure installation tool channel  74  and such that the threaded outer surfaces  78  and  79  of the closure tool  66  substantially completes the threads on the exterior of the closure  1 , FIG.  5 . The closure  1  is then threaded into the bone screw head  12 , as is also seen in FIG.  5 . FIG. 5 shows this process near the end of the installation of the closure  1 . 
     Normally, the closure  1  is not torqued tightly against the rod  7 , but is mainly used to capture the rod  7  within the head  12 . It is possible for the closure  1  to be tightened tightly to lock the rod  7  and bone screw  6  together in some embodiments, but that is normally the purpose of the set screw  9 . 
     Once the closure  1  is installed, as is seen in FIG. 5, the tools  66  and  67  are removed and the set screw  9  is inserted into the bore  47 . A third tool  91  for rotating and torquing is then utilized to rotate the set screw  9 . The torquing tool  91  includes a turning handle  93  and a socket-type head  94  that is mateable with the set screw grippable surface  61  to allow torque to be applied to the set screw  9  by turning the tool  91 . Normally the set screw  9  would be torqued to a torque sufficient to lock the rod  7  relative to the remainder of the bone screw  6 . For example, the set screw  9  may be torqued to 100 inch pounds of torque, although the exact torque may vary with the particular procedure and purpose. 
     In the illustrated embodiment the set screw  9  is a breakaway head type set screw wherein the head  52  breaks away from the base  51  at a preselected torque. This is seen in FIG.  7 . Once the head  52  breaks away from the base  51 , the installation is considered to be complete. Preferably, the base  51  includes the point  56  that engages the rod  7 . Also preferably the point  56  engages the rod  7  opposite the point of contact  23  of the rod with the seat  17 , as is seen in FIG.  9 . 
     It is foreseen that a non-breakaway head type screw may also be used in conjunction with the invention, but a breakaway head set screw provides a lower profile to the completed implant system. The set screw base  52  may also include one or more bores or the like (not shown) to allow the base  51  to be removed after the head  52  is broken away. 
     It is sometimes necessary to remove the closure  1  after it has been installed in a bone screw  6 , such as is shown in FIGS. 8 and 9. Because of the high torque applied to the overall closure  1  and set screw  5  and because the various parts are relatively small in size, it is sometimes quite difficult to remove the closure  1  should it be necessary because of implant failure, desire to rearrange the implant, or the like. 
     A pair of removal tools, including a first removal tool  96  and a second tool  97  are provided for use in removing the closure  1  from the bone screw  6 . The first removal tool  96  includes a T-shaped handle  99  and a head  100 . The head  100  includes a pair of wing shaped wedge elements  101  and  102 . The elements  101  and  102  are asymmetrical and of non-uniform radius. The elements  101  and  102  have a first end  103  that is at least as small in radius as the difference between the closure surfaces  31  and  32  as compared to the surfaces  34  and  35 . Each wedge element  101  and  102  also includes a larger central portion  104  that is substantially larger in cross-section than the difference between the closure surfaces  31  and  32  as compared to the surfaces  34  and  35 . The first end  103  and larger center portion  104  are connected by a curved surface  105  that effectively forms a cam. 
     When installed on the closure  1 , as is shown in FIG. 11, the first removal tool is rotated so as to urge the curved surface  105  of each of the wedge elements  101  and  102  against respective bone screw arms  14  and  15 . This effectively biases the arms  14  and  15  outwardly in a non-elastic manner so as to spread the arms  14  and  15  somewhat. This also has the effect of loosening the closure  1  within the arms  14  and  15  and partially turning the closure  1  with respect to the bone screw  6 , such as is shown in FIG.  13 . The first removal tool  96  is then removed from the closure  1 . 
     The second removal tool  97  includes a T-shaped handle  107  ending in a head  108 . The head  108  includes a pair of unthreaded counterparts that are partial ring shaped of uniform radius and designed and shaped to fit within the space provided by the difference in radius between the closure surfaces  31  and  32  as compared to the surfaces  34  and  35 . The procedure of installing the tool  97  is shown in FIGS. 14 and 15. The closure  1  can then be easily rotated so that the threads of the cylindrical sections  28  and  29  separate from the threads of the bone screw arms  14  and  15 , thereby allowing the closure  1  to be removed from the bone screw  6 . 
     The term “continuous” when used herein in conjunction with the term “thread” is meant to describe a thread that is sufficiently complete to allow the structure to which the thread is attached to be readily screwed into a full or partial receiving thread and may include small or slight gaps. 
     It is to be understood that while certain forms of the present invention have been illustrated and described herein, it is not to be limited to the specific forms or arrangement of parts described and shown.