Abstract:
A surgical implant driver includes a member that defines a longitudinal axis and includes a first mating surface and a second mating surface spaced from the first mating surface.

Description:
[0001]    The present disclosure generally relates to medical devices for the treatment of musculoskeletal disorders, and more particularly to a surgical system and method for treating a spine. 
       BACKGROUND 
       [0002]    Spinal disorders such as degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor, and fracture may result from factors including trauma, disease and degenerative conditions caused by injury and aging. Spinal disorders typically result in symptoms including pain, nerve damage, and partial or complete loss of mobility. 
         [0003]    Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. As part of these surgical treatments, spinal constructs, which include implants such as bone fasteners, connectors, plates and vertebral rods are often used to provide stability to a treated region. These implants can redirect stresses away from a damaged or defective region while healing takes place to restore proper alignment and generally support the vertebral members. Surgical instruments are employed, for example, to engage the fasteners for attachment to the exterior of two or more vertebral members. This disclosure describes an improvement over these prior art technologies. 
       SUMMARY 
       [0004]    In one embodiment, a surgical instrument is provided. The surgical instrument includes a member that defines a longitudinal axis and includes a first mating surface and a second mating surface spaced from the first mating surface. In some embodiments, systems and methods are disclosed. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]    The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which: 
           [0006]      FIG. 1  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
           [0007]      FIG. 2  is a break away view of components shown in  FIG. 1 ; 
           [0008]      FIG. 3  is a cross section view of the components shown in  FIG. 2 ; 
           [0009]      FIG. 4  is a break away perspective view of components shown in FIG. 
           [0010]      FIG. 5  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
           [0011]      FIG. 6  is a break away perspective view of a component of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
           [0012]      FIG. 7  is a break away cross section view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure; 
           [0013]      FIG. 8  is an end view of a component of one embodiment of a surgical system in accordance with the principles of the present disclosure; and 
           [0014]      FIG. 9  is a perspective view of components of one embodiment of a surgical system in accordance with the principles of the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0015]    The exemplary embodiments of a surgical system are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system and a method for treating a spine. In some embodiments, the system comprises a surgical instrument and related methods of use, which can be employed with spinal constructs including bone fasteners and connectors. In some embodiments, the surgical instrument can be employed with multiple types of receivers and/or screw heads. 
         [0016]    In one embodiment, the system includes a surgical instrument, such as, for example, a bone screw driver configured to interact with a shank of a bone screw and/or a receiver or head of a bone screw. In one embodiment, the system includes a driver configured to thread into a bone screw component and provide a rigid interface between the driver and the bone screw component. 
         [0017]    In one embodiment, the system includes a driver configured for use with or without a tulip head or receiver on a bone screw. In one embodiment, the system includes a driver including a mating surface, such as, for example, a spline interface configured to facilitate a rigid and/or strong interface with a bone screw. In one embodiment, the spline interface is disposed with a forward facing surface of the driver. In one embodiment, the spline interface is radially disposed about a distal end of the driver. In one embodiment, the mating surface of the driver engages a mating surface of the bone screw to resist, minimize and/or prevent toggle between the components. 
         [0018]    In one embodiment, the system includes a driver that can be employed with a bone screw having a cannulated shaft and/or a bone screw having a solid shaft. In one embodiment, the system includes a driver having a drive and/or mating surface that can be employed with and/or configured for mating engagement with a bone screw having a hexagonal and/or a torx shaped socket to allow the driver to engage the bone screw to adjust its height with a penetrated surface, such as, for example, bone. In one embodiment, the system includes a driver configured for a threaded engagement with an opening of a bone screw. 
         [0019]    In one embodiment, the system includes a driver having a square and/or rectangular drive. In one embodiment, the driver is configured for engagement with a bone screw with or without a receiver defining an implant cavity, which may be configured for disposal of a spinal rod. In one embodiment, the driver is configured for threaded engagement with the bone screw to minimize toggle. In one embodiment, the system includes a driver configured for engagement with a bone screw having a square or rectangle socket to increase strength. In one embodiment, the system includes a driver having a T25 drive to engage a socket in a bone screw. 
         [0020]    In one embodiment, the system includes a driver configured to engage a 12 point socket that allows interaction with a standard T25 drive and accepts a 12 point drive configured to deliver additional torque. In one embodiment, the system includes a driver configured with a threaded interface for engagement with a bone screw. 
         [0021]    In one embodiment, the system includes a driver configured to deliver a higher capacity of torque while preventing sheering. In one embodiment, the system includes a driver configured to increase torque and facilitate utilization of a bone screw without a receiver connected to a head portion of the screw. 
         [0022]    In one embodiment, the system includes a driver configured with radial splines configured to engage radial splines on a head of a bone screw. In one embodiment, the splines center and align the driver as well as provide a robust connection of the components parts. In one embodiment, the system includes a driver having an internal threaded shaft configured to facilitate engagement of the splined surfaces. In one embodiment, the system includes a driver having a tapered splined surface. In one embodiment, the system includes a driver having a rectangular shaped engagement to provide an increased torque. 
         [0023]    In some embodiments, the system of the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, the system of the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. In some embodiments, the disclosed system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, direct lateral, postero-lateral, and/or antero-lateral approaches, and in other body regions. The system of the present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral and pelvic regions of a spinal column. The system of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration. 
         [0024]    The system of the present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. Also, in some embodiments, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “upper” and “lower” are relative and used only in the context to the other, and are not necessarily “superior” and “inferior”. 
         [0025]    Further, as used in the specification and including the appended claims, “treating” or “treatment” of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal), employing implantable devices, and/or employing instruments that treat the disease, such as, for example, microdiscectomy instruments used to remove portions bulging or herniated discs and/or bone spurs, in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. Also, as used in the specification and including the appended claims, the term “tissue” includes soft tissue, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise. 
         [0026]    The following discussion includes a description of a surgical system including a surgical instrument, related components and methods of employing the surgical system in accordance with the principles of the present disclosure. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to  FIGS. 1-4 , there are illustrated components of a surgical system  10 , in accordance with the principles of the present disclosure. 
         [0027]    The components of system  10  can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of system  10 , individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade 5 titanium, superelastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL® manufactured by Toyota Material Incorporated of Japan), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO 4  polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TOP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations. Various components of system  10  may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of system  10 , individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of system  10  may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein. 
         [0028]    System  10 , which includes a surgical instrument, such as, for example, a driver  12 , is employed, for example, with an open or mini-open, minimal access and/or minimally invasive including percutaneous surgical technique to deliver and fasten an implant at a surgical site within a body of a patient, for example, a section of a spine. In one embodiment, the components of system  10  are configured to fix a bone fastener with tissue for a surgical treatment to treat various spine pathologies, such as those described herein. 
         [0029]    Driver  12  includes a shaft  14  extending along a longitudinal axis L 1  between an end  16  and an end  18 . In some embodiments, shaft  14  may be variously configured and dimensioned, such as, for example, planar, concave, convex or polygonal. End  16  is configured to engage an actuator, such as, for example, a surgical instrument, powered drill, hand drill, driver or other tool to rotate driver  12 , in the direction shown by arrow D and/or the direction shown by arrow DD. In one embodiment, end  16  has a square cross sectional configuration and is configured to engage a correspondingly shaped portion of the actuator. In some embodiments, end  16  may include an oval, oblong, triangular, square or polygonal cross sectional configuration configured engage a correspondingly shaped portion of the actuator. In one embodiment, end  16  includes an interchangeable driving handle removably connected to end  16  such that torque applied manually or by motorized means to the handle is transmitted to end  16 . 
         [0030]    End  18  includes a mating surface, such as, for example, a projection  20  and a mating surface, such as, for example, a sleeve  22 . As shown in  FIG. 2 , projection  20  extends from end  18  along axis L 1 . In some embodiments, projection  20  may extend in various orientations, such as, for example, transverse, series, parallel, offset or staggered. Projection  20  includes an outer surface  24 . Surface  24  includes a threaded engagement surface  26  configured for engagement with a receiving portion of an implant, such as, for example, a bone fastener  70 . Surface  26  is configured to engage fastener  70  such that toggling is reduced. In some embodiments, projection  20  may be variously configured and dimensioned, such as, for example, irregular, uniform, non-uniform, staggered, tapered, consistent or variable. 
         [0031]    Sleeve  22  extends along a portion of shaft  14 . Sleeve is circumferentially disposed about shaft  14 . In some embodiments, sleeve  22  may be variously configured and dimensioned, such as, for example, irregular, uniform, non-uniform, staggered, tapered, consistent or variable. Sleeve  22  includes an end  30  having an end facing surface  32  oriented transverse to axis L 1 . Surface  32  includes a spline surface  34  disposed radially about surface  32  and configured for engagement with a receiving portion of fastener  70 . Surface  34  is configured to engage fastener  70  such that a fixed and/or locked interface between driver  12  and fastener  70  is achieved. In one embodiment, sleeve  22  is configured for translation relative to shaft  14 . In one embodiment, sleeve  22  is fixed with shaft  14  such that projection  20  extends a distance from surface  32  to facilitate engagement of projection  20  with fastener  70 . 
         [0032]    Fastener  70  includes a head  72  configured for attachment with driver  12  and an elongated shaft  74  configured for penetrating tissue. Shaft  74  has a cylindrical cross section configuration and includes an outer surface having an external thread form. In some embodiments, the thread form may include a single thread turn or a plurality of discrete threads. In some embodiments, other engaging structures may be disposed on shaft  74 , such as, for example, a nail configuration, barbs, expanding elements, raised elements and/or spikes to facilitate engagement of shaft  74  with tissue, such as, for example, vertebrae. 
         [0033]    In some embodiments, all or only a portion of shaft  74  may have alternate cross section configurations, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered. In some embodiments, the outer surface may include one or a plurality of openings. In some embodiments, all or only a portion of the outer surface may have alternate surface configurations to enhance fixation with tissue such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured. In some embodiments, all or only a portion of shaft  74  may be disposed at alternate orientations, relative to a longitudinal axis of fastener  70 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. In some embodiments, all or only a portion of shaft  74  may be cannulated. 
         [0034]    Head  72  comprises a spherical configuration. Head  72  includes an outer circumferential surface  76  having a substantially uniform diameter thereabout. In some embodiments, all or only a portion of surface  76  includes a spherical configuration. Head  72  includes an inner surface  80  that defines a mating surface receiving portion, such as, for example a socket  82 . Socket  82  is configured for disposal of an instrument and/or tool extension, such as, for example, end  18  of driver shaft  14 , as discussed herein. Socket  82  includes a circumference and a plurality of lobes  84  disposed thereabout. Lobes  84  are uniformly spaced apart about the circumference of surface  80 . Adjacent lobes  84  are connected by arcuate portions  86 . In one embodiment, portion  86  include a threaded surface configured for engagement with threaded surface  26  of projection  20  for fixation of driver  12  with fastener  70 . Socket  82  has a hollow cross section configured for disposal of projection  20  such that rotation of driver  12 , in the direction shown by arrow D or the direction shown by arrow DD, causes rotation of fastener  70 , in the direction shown by arrow D or the direction shown by arrow DD. 
         [0035]    In one embodiment, socket  82  includes a hexagonal cross sectional configuration and is configured to engage a correspondingly shaped driver. In some embodiments, socket  82  may include an oval, oblong, triangular, square or polygonal cross sectional configuration configured engage a correspondingly shaped portion of a standard driver. 
         [0036]    Head  72  includes a mating surface receiving portion, such as, for example, a proximal face  90  extending perpendicular to axis L 1 . Face  90  defines socket  82 . In some embodiments, face  90  and/or socket  82  may be disposed at alternate orientations relative to axis L 1 , such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse. In some embodiments, face  90  may be variously configured and dimensioned, such as, for example, concave, convex, irregular, uniform, non-uniform, staggered, tapered, consistent or variable. Face  90  includes a spline surface  92  disposed radially about face  90  and configured for engagement with surface  34  of sleeve  22 . As shown in  FIG. 4 , surface  92  extends circumferentially around socket  82 . Surface  34  engages surface  92  to form a rigid connection between driver  12  and fastener  72  to increase a torque applied to fastener  70 . 
         [0037]    In assembly, operation and use, system  10 , similar to the systems and methods described herein, is employed with a surgical procedure for treatment of a spinal disorder affecting a section of a spine of a patient, as discussed herein. For example, system  10  can be used with a surgical procedure for treatment of a condition or injury of an affected section of the spine including vertebrae (not shown). In some embodiments, one or all of the components of system  10  can be delivered or implanted as a pre-assembled device or can be assembled in situ. System  10  may be completely or partially revised, removed or replaced. 
         [0038]    For example, system  10  can be employed with a surgical treatment of an applicable condition or injury of an affected section of a spinal column and adjacent areas within a body, such as, for example, vertebrae. It is envisioned that system  10  may be employed with one or a plurality of vertebra. To treat a selected section of the vertebrae, a medical practitioner obtains access to a surgical site including the vertebrae in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, system  10  can be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby the vertebrae are accessed through a mini-incision, or sleeve that provides a protected passageway to the area. Once access to the surgical site is obtained, the particular surgical procedure can be performed for treating the spine disorder. 
         [0039]    An incision is made in the body of a patient and a cutting instrument (not shown) creates a surgical pathway for implantation of components of system  10 . A preparation instrument (not shown) can be employed to prepare tissue surfaces of the vertebrae, as well as for aspiration and irrigation of a surgical region. 
         [0040]    A pilot hole or the like is made in a selected vertebra of the vertebrae for receiving a fastener  70 . System  10  is disposed adjacent the vertebrae at a surgical site and the components of system  10  including driver  12 , are manipulable to drive, torque, insert or otherwise connect fastener  70  to the vertebra. Driver  12  is translated axially relative to fastener  70 , in the direction shown by arrow E in  FIG. 2 , such that surface  26  of projection  20  mates with surface  84  of socket  82  to matingly and releasably fix driver  12  with fastener  70 . Sleeve  22  is translated along shaft  14 , in the direction shown by arrow F in  FIG. 2 , and manipulated to engage surface  34  with surface  92  to matingly and releasably fix driver  12  with fastener  70 . Fastener  70  is inserted into the vertebra with driver  12 , for example, by rotating driver  12 , in the direction shown by arrow D or the direction shown by arrow DD in  FIG. 1 , which causes rotation of fastener  70 , in the direction shown by arrow D or the direction shown by arrow DD. As fastener  70  rotates, in the direction shown by arrow D and the direction shown by arrow DD, fastener  70  translates within the vertebra. Upon completion of a surgical procedure, driver  12  may be disengaged from fastener  70 . 
         [0041]    Surgical instrument  12  may be re-assembled for use in a surgical procedure. In some embodiments, surgical instrument  12  may comprise various instruments including the mating configurations described herein, with, for example, inserters, extenders, reducers, spreaders, distractors, blades, retractors, clamps, forceps, elevators and drills, which may be alternately sized and dimensioned, and arranged as a kit. 
         [0042]    Upon completion of a procedure, surgical instrument  12 , surgical instruments and/or tools, assemblies and non-implanted components of system  10  are removed and the incision(s) are closed. One or more of the components of system  10  can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, the use of surgical navigation, microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of system  10 . In some embodiments, system  10  may include one or a plurality of plates, connectors and/or bone fasteners for use with a single vertebral level or a plurality of vertebral levels. 
         [0043]    In one embodiment, as shown in  FIGS. 5-8 , surgical system  10 , similar to the systems and methods described herein, comprises a surgical instrument, such as, for example, a driver  112 , similar to driver  12  described herein, and fastener  170 , similar to fastener  70  described herein. Driver  112  includes a shaft  114  extending along a longitudinal axis L 2  between an end  116  and an end  118 . End  116  is configured to engage an actuator, described herein. 
         [0044]    End  118  includes a projection  120  and a sleeve  122 . As shown in  FIG. 7 , projection  120  extends from end  118  along axis L 2 . Projection  120  includes an outer surface  124 . Surface  124  includes a threaded engagement surface  126  configured for engagement with a receiving portion of an implant, such as, for example, bone fastener  170 . 
         [0045]    Sleeve  122  extends along a portion of shaft  114 . Sleeve  122  includes an end  130  having a surface  134 . Surface  134  is configured to engage an engagement surface of fastener  170 , as described herein. In one embodiment, sleeve  122  includes a rectangular cross sectional configuration. In some embodiments, sleeve  122  may include an oval, oblong, triangular, square or polygonal cross sectional configuration. 
         [0046]    Fastener  170  includes a head  172  configured for attachment with driver  112  and an elongated shaft  174  configured for penetrating tissue. Head  172  comprises a spherical configuration. Head  172  includes an inner surface  180  that defines a mating surface receiving portion, such as, for example a socket  182 . Socket  182  includes a threaded surface  186  configure for engagement with threaded surface  126  of projection  120 . Socket  182  has a hollow cross section configured for disposal of projection  120  such that rotation of driver  112  causes rotation of fastener  170 . 
         [0047]    In one embodiment, as shown in  FIG. 8 , socket  182  includes a hexalobe cross sectional configuration and is configured to engage a correspondingly shaped driver. In some embodiments, socket  182  may include an oval, oblong, triangular, square or polygonal cross sectional configuration configured engage a correspondingly shaped portion of a standard driver. 
         [0048]    Head  172  includes an engagement surface, such as, for example, a proximal face  190 , which defines socket  182 . Face  190  forms a cavity  194  configured to receive sleeve  122 . Cavity  194  includes a rectangular cross sectional configuration corresponding to sleeve  122 . In some embodiments, cavity  194  may include an oval, oblong, triangular, square or polygonal cross sectional configuration. In some embodiments, an outer surface of head  172  comprises a mating surface, such as, for example, threads configured for fixed and/or locking engagement with a distal end of driver  112  to define a rigid connection between driver  112  and fastener  170 . 
         [0049]    In one embodiment, as shown in  FIG. 9 , surgical system  10 , similar to the systems and methods described herein, comprises a surgical instrument, such as, for example, a driver  212 , similar to driver  12  described herein, and a fastener  270 , similar to fastener  70  described herein. Fastener  270  includes a receiver defining an implant cavity, such as, for example, a tulip shaped head. In some embodiments, fasteners  270  can include various bone fasteners, mono-axial screws, sagittal angulation screws, fixed screws, uni-planar screws, pedicle screws or multi-axial screws used in spinal surgery. 
         [0050]    It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.