Abstract:
An assembly for use in an external fixator, structured to adjustably interconnect at least one or a plurality of bone fixation rods to a pin clamp comprising a base structurally adapted for movable, adjustable interconnection between the pin clamp and the one or more rod clamps. An elongate support shaft is movable with the base and movably connected thereto and at least one or alternatively a plurality of rod clamps are mounted on the support shaft. Each of the plurality of one or more rod clamps is structurally adapted to secure a different fixation rod to the support shaft. The one or more rod clamps are movably connected and adjustably positioned on the support shaft in adjacent relation to one another. The base, the support shaft and one or more rod clamps are movably interconnected relative to one another to define a substantially universal disposition of said plurality of rod clamps relative to the pin clamp.

Description:
CLAIM OF PRIORITY 
     The present application is based on and a claim of priority is made under 35 U.S.C. Section 119(e) to a provisional patent application that is in the U.S. Patent and Trademark Office, namely, that having Ser. No. 62/144,043 and a filing date of Apr. 7, 2015, and which is incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present invention is directed to an assembly for use in combination with in an external fixator and is structured to adjustably interconnect one or more bone fixation rods to a pin clamp in a manner which significantly enhances the ability to dispose the one or more fixation rods relative to the pin clamp and bone pins operatively associated therewith, in a preferred orientation to efficiently, reliably and correctly stabilize the skeletal component, with which the external fixator is procedurally associated. 
     Description of the Related Art 
     Many bone fractures are complex and cumbersome to treat. Accordingly, not all bone fractures heal within the same time. Simple fractures take far less time to heal, if no other complications are involved. On the other hand, most complex bone fractures can take several weeks to heal. In any event, a broken bone has to be stabilized and supported until it is strong enough to handle external factors like body weight and movement. 
     Assuming the above, medical practitioners can typically treat a bone fracture with internal fixation assemblies and/or external fixation assemblies depending on the nature and severity of the fracture. In internal fixation, the surgeon typically conducts a surgical procedure to set the bone fracture in place. As such, the bone fragments may be first repositioned into the normal alignment and secured with special implants such as plates, screws and wires. 
     In contrast, external fixation assemblies or “external fixators” involves a surgical treatment used to stabilize broken bones at a predetermined proximity from the operative or injury area. In external fixation, metal bone pins typically including a threaded structure are attached to the bone after passing through miniscule incisions into the skin and muscle portions associated with the site of the broken bone. The bone pins are secured to a pin clamp or like pin securing device located exteriorly of the corresponding body part, outside the skin. In addition, in order to provide adequate stability and elongated bone fixation rod serve to interconnect the pin clamps and corresponding ones of the bone pins which are secured to different bone segments on opposite sides of the break or fracture. Accordingly, external fixators provide unhindered contact to the relevant skeletal structures for their initial assessment. External fixators also allow for secondary interventions which may be desirable to restore bony continuity of skeletal structures of the body. 
     Accordingly, it is recognized that external fixator assemblies do in fact exist and are used in the medical profession for an appropriate procedure relating to the healing, mending, and stabilizing, of broken or fractured bones. However, many of the known external fixator devices or and/or assemblies have at least somewhat limited operability at least to the extent of adjusting the operative components thereof so that the bone pins, pin clamp, and bone fixation rods can be properly positioned and oriented relative to one another to facilitate a stabilization and healing of the skeletal component being treated. 
     More specifically, many known or conventional external fixator assemblies do not have sufficient versatility, at least in terms of facilitating adjustable orientation of the external fixator assembly, to allow precise and accurate positioning thereof in the bone stabilization process. Accordingly, an imprecise positioning and/or orientation of external fixators as well as the lack of adequate stabilization can restrict the joint motion, cause infections and take much longer for the broken bone to heal. 
     Therefore, there is a need in the medical profession for an assembly structured for operative association with an external bone fixator that facilitates the precise positioning and orientation of the various components of the external fixator assembly including, but not limited to, relative placement of the pins, pin clamp and bone fixation rod. Further, in many of the more complex bone breaks or fractures it is necessary and/or desirable to interconnect associated bone pins and corresponding pin clamps used to treat a common break or fracture with a plurality of the aforementioned bone fixation rods in order to increase, maintain or assure proper stability. 
     More specifically, such a preferred adjustment assembly should be capable of a substantially universal range of motion and positioning of one or more bone fixation rods relative to an associated and/or corresponding pin clamp and bone pins. Further, such an adjustment assembly should have sufficient versatility to be used with a single pin clamp or a plurality of pin clamps while maintaining the ability to substantially universally position operative components of the external fixator as believed necessary by medical personnel. 
     SUMMARY OF THE INVENTION 
     This invention is intended to present a solution to these and other needs which remain in the relevant field of art. As such, these and other objects, features and advantages of the present invention will become clearer when the drawings as well as the detailed description are taken into consideration. 
     More specifically, the present invention is directed to an adjusting assembly for use in combination with an external fixator device. The assembly is structured to adjustably interconnect and substantially universally position one or more fixation rods in stabilizing relation to a pin clamp and associated bone pins embedded in the skeletal component being treated. Moreover, the structural features of the one or more embodiments of the adjusting assembly of the present invention significantly enhances the versatility of conventional and/or customized external fixators, at least to the extent of facilitating a preferred positioning of the pin clamp and associated bone pins relative to one or more stabilizing bone fixation rods. 
     Accordingly, at least one preferred embodiment of the adjustment assembly comprises a base including an elongated shank portion and a head portion fixedly secured thereto. The shank of the base is dimensioned and configured to be telescopically inserted or otherwise movably attached to a conventional or customized coupling structure. In turn, the coupling structure serves to interconnect the pin clamp to a remainder of the external fixator and directly to the adjustment assembly of the present invention. Therefore, when in an assembled mode, the shank and the head of the base are movably and more specifically rotationally connected to the pin clamp coupling member. As set forth in greater detail hereinafter, additional structural features are associated with and/or integrated in the base in order to facilitate the enhanced, substantially universal positioning of at least one and, when preferred, a plurality of fixation rod clamps. 
     In addition, an elongated support shaft is movably connected to the base and extends radially and linearly outward from the head portion while being connected thereto. Further, the cooperative structural features of the base and the support shaft facilitate the positioning of the support shaft outwardly from the head portion at least in a substantially radial direction. As such, a connecting structure, preferably in the form of a ball and socket connecting structure is integrated in a corresponding end portion of the support shaft as well as a receiving portion of the base. The ball and socket connection is disposed and structured to facilitate a rotational/pivotal attachment of the support shaft relative to the head portion and shank. As such, the support shaft is movable with the base and is also pivotal outwardly there from through a predetermined and preferred arcuate path. In at least one preferred embodiment the arcuate path of the support shaft may extend along substantially 180°. 
     To facilitate a substantially universal range of motion and placement of the one or more fixation rod clamps, the head portion of the base includes at least one elongated channel formed therein and preferably extending across the entirety of the head portion. Further, the channel may include oppositely disposed open ends. As such, the support shaft may be disposed radially outward from the head portion when in a substantially perpendicular relation to the shank or length of the base. In such a radial orientation, the support shaft is disposed along a length of the channel, while extending outwardly from one of the open ends thereof. Therefore, the support shaft may move with the base while being disposed in the aforementioned radial orientation concurrently to being substantially perpendicular to the length of the base or shank. 
     However, the overall length of the support shaft is such that a significant portion thereof extends beyond the head and/or channel in which it may be operatively disposed. As a result, the length of the support shaft is sufficient to have movably and adjustably mounted thereon at least one but in certain preferred instances a plurality of at least two fixation rod clamps. Moreover, each of the rod clamps is disposed and structured to engage and or “clamp” a different one of a corresponding number or plurality of bone fixation rods. As a result, additional stability may be provided to an exterior fixator assembly when required to maintain cooperatively disposed pin clamps and pins in a stable relation to one another and to the skeletal component being treated. 
     In addition, an adjustment assembly is movably and adjustably connected to the support shaft in cooperative relation to the one or more rod clamps. As a result, predetermined manipulation of the adjustment assembly will serve to increase or otherwise facilitate the clamping and/or gripping force each of the one or more rod clamps will exert on a corresponding bone fixation rod with which it is engaged. 
     Therefore and as described in greater detail hereinafter, the structural and operative features of the adjustment assembly of the present invention is capable of defining a substantially universal range of motion and or disposition of the one or more rod clamps operatively connected to the support shaft thereby facilitating a preferred and accurate orientation of one or more bone fixation rods relative to one or more interconnected pin clamps and associated bone pins embedded in the bone of the patient. 
     As used herein, the term “universal” is more definitively defined as a combination of relative movements of the base, the support shaft and the plurality of rod clamps being movably interconnected to one another to define a substantially “universal” disposition of the one or more rod clamps and associated fixation rods relative to the one or more pin clamps, which is intended to be stabilized. 
     In even more specific terms, the base is preferably rotational relative to the pin clamp coupling member; the support shaft is pivotally/rotationally connected to and movable with the base, as the base moves relative to the coupling member and the one or more rod clamps are adjustably movable and positionable on the support shaft and movable therewith, as the support shaft moves with and relative to the base and the base moves relative to the coupling member and corresponding pin clamp. As a result, the one or more rod clamps may be effectively oriented and positioned throughout a substantially universal range of movement and disposition. This results in facilitating an enhanced and preferred orientation of the one or more bone fixation rods relative to the pin clamp and bone pins anchored into the skeletal component of the patient. 
     These and other objects, features and advantages of the present invention will become clearer when the drawings as well as the detailed description are taken into consideration. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which: 
         FIG. 1  is a perspective view of one preferred embodiment of the adjustment assembly of the present invention represented in an at least partially assembled relation to other components of an external fixator. 
         FIG. 2  is a top perspective view of the embodiment of  FIG. 1 . 
         FIG. 3  is a side perspective view of the embodiment of  FIGS. 1-2 . 
         FIG. 4  is a side perspective view, opposite to that of  FIG. 3 , of the embodiment of  FIGS. 1-3 . 
         FIG. 5  is a perspective view of yet another preferred embodiment of the adjustment assembly of the present invention. 
         FIG. 6  is a side perspective view of the embodiment of  FIG. 5 . 
         FIG. 7  is a perspective view of a base associated with the embodiment of  FIGS. 5-7  and with structural modifications, associated with the embodiment of  FIGS. 1-4 . 
         FIG. 8  is one embodiment of a rod clamp structurally modified to include to cooperative pieces. 
         FIG. 9  is a perspective view of a prior art external fixation assembly operatively associated with a skeletal component being treated. 
     
    
    
     Like reference numerals refer to like parts throughout the several views of the drawings. 
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     As represented throughout the accompanying Figures and with initial and primary reference to  FIGS. 1-4 , the present invention is directed to an adjustment assembly generally indicated as  10 , intended to be used in combination with an external fixation assembly. 
     In order to clarify the environment in which the assembly  10  is utilized,  FIG. 9  discloses a known and/or prior art example of an exterior fixator assembly generally indicated as  100 . As practically applied, a plurality of bone pins  102  are embedded in a bone or skeletal component under treatment. In addition, while not shown in the example represented in  FIG. 9 , one or more pin clamps or like gripping devices  104  are positioned on the exterior of the user&#39;s body adjacent the bone under treatment. As such, the plurality of bone pins pass through soft-tissue components of the area into embedded relation with the bone, as represented. A stable, relative disposition between the pin clamps  104  is accomplished by their interconnection using a leg fixation rod  106 . The interconnecting relation of the fixation rod  106  provides stability to the overall exterior fixation assembly  100 . In addition, the plurality of pin clamps  104  are connected to the bone pins  102  so as to maintain them in an intended position relative to one another and to other, cooperatively positioned bone pins  102 ′ also embedded in the bone being treated. The pin clamps  104  are stabilized through the provision of the one bone fixation rod  106  disposed in interconnecting relation to and between the pin clamps  104 . Fixation rod clamps  108  are disposed in gripping, clamping relation to corresponding portions of the bone fixation rod  106  and serve to interconnect the fixation rod  106  to each of the pin clamps  104 . 
     Further, a coupling member  110  is provided to interconnect each of the rod clamps  108  to a remainder of the corresponding pin clamps  104 . As such, a movable relation between each of the rod clamps  108  is accomplished by the aforementioned coupling member  110 . As is recognized in the medical profession proper placement of the bone fixation rod  106  relative to the interconnected pin clamps  104  is important in order to provide meaningful stability to the overall external fixator assembly  100 . 
     The prior art structure represented in  FIG. 9  is representative only of possibly structured external fixators but considered to be operable for its intended purpose and function. However, one factor not represented is the frequent requirement for the utilization of a plurality of bone fixation rods, as at  106 , in order to provide additional stability in cases of severely damaged bone(s) or more difficult or complex damage to the bone(s) being fixated. Further, the proper orientation of the rod clamps  108  and bone fixation rod  106  is important in order to provide meaningful stability to the bone pins  102  regardless of their relative position and orientation. 
     Again, with primary reference to  FIGS. 1-4 , the adjustment assembly  10  of the present invention comprises a base generally indicated as  12  and  12 ′ including a head portion  14 ,  14 ′ and elongated shank or body portion  16  structurally modified in accord with one other embodiment of the present invention and represented in detail in  FIG. 7 . The shank  16  has a smaller transverse dimension than the somewhat enlarged head  14 ,  14 ′ and is cooperatively dimensioned to pass telescopically within the interior of the housing  110 ′ of the coupling member  110 . In addition, one end of the shank  14  may be peened or otherwise structured to maintain the shank  14  within the interior of the housing  110 ′. In addition the base  12  includes a flange  18  or under portion of the head  14 ,  14 ′ which is disposed in abutting relation to the open end  110 ″ of the housing  110 ′. As a result, the shank  16  is effectively retained within the interior of the housing  110 ′. However, the shank  16  is further dimensioned and configured to allow rotation thereof within the housing  110 ′ to further facilitate adjustable positioning of the remainder of the assembly  10  and allow a universal positioning of portions thereof. Such universal positioning facilitates more freedom of medical personnel to properly dispose, orient and align one or more bone fixation rods  106 , as described in greater detail hereinafter. 
     Yet additional structural features associated with the base  12  are represented in the structurally modified base  12 ′ represented in  FIG. 7 . More specifically an access opening  31  is integrally formed in at least a portion of the shank  16  and extends along a length thereof as represented. Further, the access opening  31  has an upper or innermost end disposed in communicating relation with channel  28 . In addition, the ball  24  of the ball and socket connection  22  is allowed to be inserted into and removed from its rotational/pivotal attachment to the base  12  by passing through the upper end of the access opening  31  and along at least a portion of the length thereof. Assembly of the support shaft  20  into its universal movement relative to the base  12  is thereby facilitated. 
     The assembly  10  further includes an elongated support shaft  20  having one end movably connected and retained to the base  12  preferably by the aforementioned ball and socket connection  22 . More specifically, one end of the support shaft  20  includes a ball structure  24  integrally or fixedly formed thereon. The ball structure  24  is received within a socket  25  integrated into an inner portion of the head  14 , as represented in at least  FIG. 4 . Therefore, the ball and socket connection  22  between the support shaft  20  and the base  12  allows both a rotational and pivotal motion of the support shaft relative to the base  14  concurrently to facilitating movement of the support shaft with the base  14 , as the shank  16  rotates within the interior of the housing  110 ′. 
     In order to accomplish what may be accurately referred to as a “universal” adjustable positioning of the assembly  10 , relative to the coupling  110  and a pin clamp associated therewith, the head  14  further includes at least one elongated channel  28  formed therein. The channel  28  includes oppositely disposed open ends  28 ′ through which the support shaft  20  may pass when disposed in a radially outward extended relation to the base  12 , as represented throughout  FIGS. 1-4 . Such a radially outward extending relation is concurrent to the support shaft  20  being disposed in substantially perpendicular relation to a remainder of the base  12  specifically including the somewhat elongated shank  16 . Moreover, it should be further noted that the provision of the ball and socket connection  22  facilitates a pivotal motion of the support shaft relative to the base  12  and head  14  through a substantially arcuate path as schematically represented by directional arrow  200  in  FIG. 2 . In at least one embodiment, the arcuate path includes a range of substantially 180°. In traversing the 180° arcuate path  200 , the support shaft  20  will extend along the length of approximately one half of the channel  28  and extend through a corresponding open end  28 ′ thereof. However, upon traversing the arcuate path  200  the support shaft will extend along the other half of the channel  28  and extend outwardly from the opposite open end  28 ′. 
     Therefore, in order to accomplish proper disposition and orientation of the assembly  10 , the support shaft  20  may be pivoted about the ball and socket connection  22  and be disposed within the interior of the channel  28  so as to extend outwardly from either opposite end  28 ′. In addition, the adjustable versatility of the assembly  10  may be further demonstrated by a positioning of the support shaft linearly or angularly outward from the head  14  as perhaps more clearly demonstrated in the additional preferred embodiment of  FIGS. 5 and 6 , described in greater detail hereinafter. 
     As also demonstrated throughout  FIGS. 1-4 , the length of the support shaft  20  is such that a significant portion thereof  30  and  32  extends beyond the head  14  and the open end  28 ′ of the channel  28  through which it passes. Accordingly, the support shaft  20  is dimensioned and structured to have movably mounted thereon at least one but in certain preferred applications a plurality of fixation rod clamps  30  and  32 . Further, each of the clamps are initially rotatable about the support shaft  20  and are also movable therewith as the support shaft moves relative to and with the base  12 . Therefore, each of one or more rod clamps  30  and  32  may be selectively disposed and oriented to clamp, grip or otherwise securely but removably engage a different fixation rod, such as of the type represented as  106  in the prior art representation of  FIG. 9 . 
     As is further noted, each of the one or more fixation rod clamps  30  and  32  comprises separated segments  30 ′ and  32 ′, which are initially separated from one another to facilitate clamping or gripping engagement with different ones of the fixation rods  106  with which they are used. However, the assembly  10  further comprises an adjustment assembly generally indicated as  36 . The adjustment assembly  36  includes an adjustment nut or like structure  38  secured to a rotational knob or like member  40  both of which are preferably threaded (not shown) onto an outer or distal end of the support shaft  20 . Accordingly, rotation of the adjustment nut  38  in an appropriate direction will cause an inward movement of the nut  38 . This in effect will tighten and/or close the rod clamps  30  and  32 , bringing them into immediately adjacent relation to one another. Concurrently, each of the rod clamps  30  and  32  will have their respective segments  30 ′, 30 ′ and  32 ′, 32 ′ close into a gripping or clamping engagement about different, corresponding fixation rods, which would be disposed within the open receiving portions  39  of each of the rod clamps  30  and  32 . 
     Therefore, due to the relative movements of the base  12  relative to the coupling member  110 ; the support shaft  20  movable relative to the base  12  and the one or more rod clamps  30  and  32  on and relative to the support shaft  20 , the one or more rod clamps  30  and  32  can be substantially universally positioned and/or oriented relative to the coupling member  10  and more specifically the pin clamp  104  to which it is connected. 
     As set forth above, an additional embodiment of the assembly is represented in  FIGS. 6 and 7  and is generally represented as  10 ′. This embodiment may be considered at least partially structurally equivalent to the assembly  10  of the embodiment of  FIGS. 1-4 . As such, like parts include like numerical designations in the preferred embodiments of  FIGS. 1-4  and  FIGS. 6 and 7 . However, in the embodiment of  FIGS. 6 and 7 , the assembly  10 ′ includes a connecting link  50  having the ball and socket connection  22  movably connecting one end of the link  50  to the coupling member  110 . The oppositely disposed outer or distal end of the link  50  has a substantially T-shaped configuration including a transverse segment  52 . The segment  52  is disposed dimensioned and configured to be removably gripped or clamped within a receiving portion  39 ′ of one of the rod clamps  30 ,  32  in order to interconnect the support shaft  20  in an operative position relative to the coupling member  110 . 
     As also set forth above, structural modifications of the base  14 ,  14 ′ are represented in  FIG. 7 . More specifically, the head portion  14 ′ of the base  12 ′ used in the embodiment of  FIGS. 6 and 7  includes a plurality of channels  28  and  29  disposed in a “crossed” or perpendicular, transverse relation to one another. In contrast, the head  14  of the base  12  may only include a single channel  28 . However, the versatility of the different embodiments  10  and  10 ′ of the assembly is such that the base  12  and  12 ′, as represented in  FIGS. 1-7 , could be used interchangeably if desired. As should be apparent, the provision of a plurality of two channels  28  and  29  in the head  14 ′ provides an increased range of motion in that the link  50  may extend through at least a portion of either the channels  28  and  29  and extend out of corresponding opposite open ends thereof. 
     An additional orientation of the link  50  is disclosed as extending substantially linearly and/or coaxially outward relative to the length of the base  12 ′ and or associated shank  16 ,  16 ′. However, it is further emphasized that the link  50  may also be positioned both rotationally and pivotally relative to the head  14 ′ based on the provision of the ball and socket connection  22  as described in greater detail above. 
       FIG. 8  is directed to an additionally modified fixation rod clamp having a two-piece construction being generally indicated as  60 . The clamp  60  includes segments  62  and  64  separated substantially longitudinally by a junction  66 . Also, when connected together in an operative manner, as represented, a tongue and groove type connection generally indicated as  68  serves to facilitate attachment of the two segments  62  and  64 . The tongue and groove connection  68  also facilitates alignment of corresponding and/or cooperative portions or components of the two segments  62  and  64 . In order to maintain the two segments  62  and  64  in their assembled orientation, as represented in  FIG. 8 , a washer made of Silicon or other appropriate material, having at least some flexibility, may be disposed in surrounding relation to a receiving flange  70 . As a result, minimal separation between the segments  62  and  64  may occur, such as when a bone fixation rod is forced through an open end, generally indicated as  72  into the rod receiving/gripping area  74 . As should also be apparent the two-piece fixation rod clamp has a reduced transverse dimension at its lower portion generally indicated as  76 . This facilitates a telescopic insertion thereof into a known, conventional and/or customized coupling member such as, but not limited to, coupling member  110  described above and shown throughout the accompanying Figures. 
     Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents. 
     Now that the invention has been described,