Abstract:
A proximal femoral ball assembly having a variable offset that is selectively adjustable to conform to various anatomical conditions encountered during a femoral surgical procedure. The femoral ball assembly generally includes a head, a neck, and an adjustment mechanism. The head has a smooth spherical outer surface that is adapted to engage an acetabular component or native acetabulum. The neck extends outward from the head and removeably connects to the head using a threaded attachment.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application is a continuation of and claims priority under 35 U.S.C. §120 to nonprovisional patent application Ser. No. 10/613,334, filed on Jul. 3, 2003, now U.S. Pat. No. 7,306,629, the disclosure of which is expressly incorporated by reference herein. 
    
    
     BACKGROUND 
     1. Field of the Invention 
     The disclosure generally relates to implantable orthopedic prostheses for total hip arthroplasty and, more particularly, to a proximal femoral head assembly having a variable offset that is selectively adjustable to conform to various anatomical conditions encountered during a femoral surgical procedure. 
     2. Background of the Invention 
     During a total hip arthroplasty, a femoral stem is implanted into the intramedullary canal of a femur. After the stem is inserted to the proper depth and orientation, a femoral head or ball is attached to the proximal end of the stem. This head fits into the socket of an acetabular component and provides a joint motion surface for articulation between the femoral prosthesis and acetabulum. A neck or trunion extends between the femoral ball and stem. In many embodiments, this neck generally has a cylindrical configuration with one end connected to the ball and one end connected to the stem. 
     Several critical features are important to ensure that the femoral hip prosthesis properly functions once implanted in the femur. One of these features is the femoral head “offset.” Femoral offset is the horizontal distance from the center of rotation of the femoral head to a line bisecting the long axis of the femur from a standing A-P x-ray. Similarly, the offset of the proximal femoral component of a hip prosthesis is the horizontal distance from the center of rotation of the femoral head to the long axis of the stem. 
     One important decision that must be made during hip surgery is how much offset should occur between the femoral ball and stem. If the offset does not match the natural anatomical needs of the patient, then the prosthesis can be positioned too far laterally or medially. An unnecessary decrease in offset greatly affects the success and proper function of the hip implant after surgery. 
     A decrease in femoral offset medially shifts or moves the femur closer to the pelvis. This decrease can result in impingement of the prosthesis for some patients after surgery. A medial shift can also cause soft tissue surrounding the implant to become loose or lax. Impingement and soft tissue laxity can further lead to instability of the implant, subluxation, and even dislocation. As a further disadvantage, when the offset decreases, the abductor muscles utilize a greater force to balance the pelvis. This increase in force creates a discrepancy that may result in a limp for the patient. As another consequence, the resultant force across the hip joint also increases, and this increase can lead to greater polyethylene wear between the femoral ball and prosthetic acetabular component. 
     In contrast to a decreased offset, an increase in femoral offset laterally shifts or moves the femur farther from the pelvis. In some instances, an increase in offset is desirable. This increase can reduce the risk of impingement and improve soft tissue tension, resulting in a more stable implant. Further, the adductor muscles can be more properly balanced and improve the gait of the patient. Further, proper balance and alignment can lead to less wear and loosening over time. 
     Manufacturers and designers of femoral hip prosthesis recognize the shortcomings associated with decreased offset and endeavor to match the offset with the anatomical needs of the patient. In order to remedy these shortcomings, femoral hip prostheses are sold with different offsets. The number and degree of different offsets vary between the manufacturers. A typical prosthetic system can include three to five different offsets for each femoral ball size. For example, a manufacturer may provide femoral balls with offsets of −4 mm, 0 mm, +4 mm, +8 mm, and +12 mm. These offsets would be available for five or six different ball sizes. In short, the manufacturer is required to have an inventory of 18 to 30 different femoral heads. 
     An inventory of femoral heads of this magnitude is enormous. Further, the costs associated with maintaining and distributing this inventory are very great for a company. This large inventory, then, is a clear disadvantage. 
     As another important disadvantage, manufacturers offer the femoral head offsets in fixed, discrete, large increments. As noted, the offsets, for example, may be offered in increments of −4 mm, such as offsets of −4 mm, 0 mm, +4 mm, +8 mm, and +12 mm. These fixed increments though may not exactly match the anatomical offset that the patient needs. For example, if the patient requires an offset of +6 mm, then the surgeon must choose between an offset of either +4 mm or +8 mm. 
     It therefore would be advantageous to provide a proximal femoral head having a variable offset that is selectively adjustable to conform to various anatomical conditions encountered during a femoral surgical procedure. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to implantable orthopedic prostheses for total hip arthroplasty and, more particularly, to a proximal femoral ball assembly having a variable offset that is selectively adjustable to conform to various anatomical conditions encountered during a femoral surgical procedure. 
     The femoral ball assembly generally comprises a head, a neck, and an adjustment mechanism. The head has a smooth spherical outer surface that is adapted to engage an acetabular component or native acetabulum. The neck extends outward from the head and removeably connects to the head using a threaded attachment. 
     The adjustment mechanism provides a variable offset for the femoral ball assembly. More specifically, the adjustment mechanism varies the length that the neck protrudes from the head. As this length increases, the femoral offset correspondingly increases. As this length decreases, the femoral offset correspondingly decreases. One important advantage then is that the surgeon can intra-operatively select from a wide array of femoral offsets. These offsets can be provided with a small number of components. As such, a large, expensive inventory of differently sized femoral balls with different offsets is not necessary. 
     Another advantage of the present invention is that a plurality of femoral offsets can be offered in small increments. The offsets, for example, can be offered in 1 mm increments. These small increments can be used to more closely match the natural anatomical needs of the patient. Further, these offsets can be offered in a range from about −10 mm to about +10 mm, but a range of up to about +30 mm is within the scope of the invention. 
     In another embodiment, a femoral ball system is provided. The system has a plurality of differently sized femoral heads and spacers. These heads and spacers can be utilized with a single neck to provide a multitude of femoral offsets with a plurality of differently sized spherical heads or balls. 
     In yet another embodiment, two separate axes extend through the femoral ball assembly. A first axis or central axis is concentric with the body of the spherical head, and a second axis or eccentric axis is concentric with the threaded bore of the head. This second axis is also concentric with the adjustment mechanism and neck of the femoral ball assembly. These two axes are parallel to each other and form an acute angle with the longitudinal axis of the stem. 
     In one form thereof, the present invention provides an assembly, including a femoral head assembly connectable to a femoral hip stem, the assembly including: a femoral head having a body with a spherical outer surface adapted to articulate within an acetabular component, the body having a threaded bore; a plurality of spacers of varying thickness, at least one of the plurality of spacers adapted to be inserted into the threaded bore; a first neck having an externally threaded portion and at least one of an external tapered portion and an internal bore defining a internal tapered portion, the externally threaded portion being adapted to be threadably engaged with the threaded bore of the body of the femoral head; wherein the first neck is adapted to extend outwardly from the femoral head in various lengths, each length corresponding to the thickness of the at least one of the plurality of spacers inserted into the threaded bore; and a femoral hip stem, the femoral hip stem having a second neck including at least one of an external tapered surface and a tapered internal bore, the one of the external tapered surface and the tapered internal bore of the femoral hip stem sized to engage the one of the external tapered portion and the internal bore of the first neck to form a Morse taper connection between the femoral hip stem and the first neck. 
     In another form thereof, the present invention provides an assembly including: a femoral head having a body with an outer surface adapted to articulate with an acetabular component, the femoral head comprising an internally threaded bore; a first neck having a first externally threaded end adapted to be threadingly connected to the internal threaded bore of the femoral head and a second end comprising at least one of an external tapered portion and an internal tapered bore; a femoral hip stem, the femoral hip stem comprising a second neck having at least one of an external tapered surface and a tapered internal bore, the at least one of the external tapered surface and the tapered internal bore of the femoral hip stem sized to engage the at least one of the external tapered portion and the internal tapered bore of the first neck to form a Morse taper connection between the femoral hip stem and the first neck; and at least one spacer adapted to be positioned within the internally threaded bore of the femoral head between the first end of the first neck and the femoral head, wherein the at least one spacer engages the first end of the first neck and a bottom surface of the internally threaded bore of the femoral head when the first neck is threadingly coupled and seated in the internally threaded bore of the femoral head, the first neck extending outwardly from the femoral head by a length that corresponds to a thickness of the at least one spacer positioned within the internally threaded bore. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an exploded view of a femoral hip stem, an assembled femoral ball assembly according to the invention, and an acetabular component. 
         FIG. 2  is an exploded view of the femoral ball assembly according to the invention. 
         FIG. 3  is an exploded view of an alternate embodiment of the femoral ball assembly. 
         FIG. 4  is an exploded view of an alternate embodiment of the femoral ball assembly. 
         FIG. 5  is an exploded view of a femoral ball system according to the invention. 
         FIG. 6  is an exploded view of an alternate embodiment of the femoral ball assembly. 
         FIG. 7  is an exploded view of another embodiment of the femoral ball assembly. 
         FIG. 8  is an exploded view of yet another embodiment of the femoral ball assembly. 
         FIG. 9  is an enlarged perspective view of the assembled femoral ball assembly of  FIG. 8 . 
         FIG. 10  is an exploded view of another embodiment of the femoral ball assembly. 
     
    
    
     DETAILED DESCRIPTION 
     Looking to  FIG. 1 , an implantable orthopedic femoral hip stem or implant  10 , a proximal femoral head or ball assembly  12  according to the invention, and an acetabular component  14  are shown. These components are connectable together for use in a total hip arthroplasty. 
     Stem  10  includes a body  20  that extends from a proximal region  22  to a distal region  24 . A longitudinal or long axis  25  extends through the body. The body tapers downwardly and generally has a cylindrical or trapezoidal shape with the distal end being rounded to facilitate insertion into the intramedullary canal of a femur. The proximal region  22  includes a proximal body portion or trochanteral portion  26  having a cylindrical bore  28 , a collar  30 , and a top surface  32 . A neck  34  extends outwardly from the top surface  32 . The neck  34  has a tapered body that connects to the femoral ball assembly  12 . 
     The acetabular component  14  is configured to fit in the acetabulum of a patient and is formed from an outer shell  40  and an inner liner or bearing component  42 . The shell is generally shaped as a hemispherical cup defined by an outer hemispherical surface or bone engaging surface and an inner hemispherical surface connected to the bearing component. The outer surface can be porous or textured while the inner surface is smooth and adapted to articulate with the femoral ball assembly  12 . 
     One skilled in the art will appreciate that the femoral ball assembly of the present invention can be employed with various implants and implant designs without departing from the scope of the invention. The stem  10 , for example, can be the Apollo™ Hip or Natural™ Hip manufactured by Centerpulse Orthopedics Inc. of Austin, Tex.; and the acetabular component  14  can be the Allofit™ or Converge™ acetabular system manufactured by the same company. 
     Looking now to  FIGS. 1 and 2 , the femoral ball assembly  12  is adapted to connect at one end to the femoral hip stem  10  and at another end to the acetabular component  14 . The femoral ball assembly  12  comprises a head  50 , a neck  52 , and an adjustment mechanism  54 . A central axis  56  extends through the center of the head, the neck, and adjustment mechanism. 
     Head  50  has a body that is shaped as a partial sphere. This body has a smooth outer surface  60  adapted to engage and slideably articulate with the bearing component  42  of the acetabular component  14 . A collar or tapered transition  62  circumferentially extends around a base  64  of the spherical body. A threaded and cylindrical bore  66  extends into the body. 
     Neck  52  has a generally straight cylindrically shaped body that extends from a first end  70  to a second end  72 . The first end  70  includes a bore  74  adapted to receive and engage neck  34  of stem  10 . Specifically, bore  74  has a tapered cylindrical shape with smooth inner walls. This taper is adapted to form a Morse taper connection with neck  34  when stem  10  and femoral ball assembly  12  are connected together. Preferably, bore  74  does not extend completely through neck  52  but stops at a generally planar end surface  76  shown as dashed lines inside the body. The second end  72  includes an externally threaded section  78 . This threaded section is adapted to threadably engage with threaded bore  66  of head  50 . 
     Adjustment mechanism  54  is adapted to vary the effective length “L” (shown in  FIG. 1 ) of neck  52  extending outwardly from head  50 . Effective length “L” extends from first end  70  to base  64  of the body of the head  50 . Adjustment mechanism  54  is further adapted to provide a variable “offset” between the femoral head assembly  12  and femoral stem  10 . Femoral offset is the horizontal distance from the center of rotation of the femoral head to a line bisecting the long axis  25  of the femur from a standing A-P x-ray. Similarly, the offset of the proximal femoral component of a hip prosthesis is the horizontal distance from the center of rotation of the femoral head to the long axis of the stem. 
     As shown in  FIG. 2 , adjustment mechanism  54  includes a spacer  80 . This spacer has a short cylindrical shape and is preferably formed as a solid round or coin-shape. Spacer  80  is adapted to be removeably positioned in bore  66  of head  50 . 
     An adjustment mechanism of the present invention may be used in various ways to provide a variable offset between the femoral head and femoral stem.  FIG. 2  shows one example. While spacer  80  is removed from the bore  66 , neck  52  can be threadably connected to head  50 . Once the neck is fully seated and threaded into bore  66 , the neck  52  will have an effective length L 1 . This length equals the distance from first end  70  to base  64  of head  50 . Neck  52  can be removed from head  50  and spacer  80  then placed inside of bore  66 . Spacer  80  has a thickness equal to T. With the spacer  80  placed in bore  66 , neck  52  can be threadably connected to head  50 . Once the neck is fully seated and threaded into bore  66 , the neck  52  will have an effective length L 2 , wherein L 2 =L 1 +T. In other words, the spacer lengthens the distance from first end  70  to base  64  an amount equal to its thickness T. 
     The embodiment in  FIG. 2  is able to provide a femoral ball with two different offsets between the femoral head and femoral stem. The length difference between these two offsets depends on the thickness of the spacer. The spacer can be sized to have various thicknesses. As such, the offset can be varied by varying the thickness of the spacer. Further, a plurality of spacers with different thicknesses can be provided. For example, these spacers could have thicknesses with one millimeter increments, such as 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, etc. Other increments, of course, are within the scope of the invention. 
       FIGS. 1 and 2  show a Morse taper connection between the neck  34  of stem  10  and neck  52  of femoral ball  12 . In this connection, neck  52  functions as the female component and neck  34  functions as the male component. One skilled in the art will appreciate that this connection can be altered and still within the scope of the invention. For example, neck  34  can be formed with a bore to function as the female component, and neck  52  can be formed as a solid tapered cylinder to function as the male component. Various types of other connections could also be employed to connect the stem to femoral ball assembly and still remain within the scope of the invention. These connections include, but are not limited to, press-fit connections, locking rings, radial or expandable devices (such as sleeves or collars), nitinol or other superelastic materials, taper connections, locking connections, various polygonal connections (such as triangular, square, hexagonal, or trapezoidal), and the like. In short, various ways can be used to connect the femoral ball  12  to the stem  10 . 
     Looking now to  FIG. 3 , an alternate femoral ball assembly  100  is shown and includes a head  102 , a neck  104 , and an adjustment mechanism  106 . Head  102  and neck  104  are identical to head  50  and neck  52  described in connection with  FIGS. 1 and 2 . In  FIG. 3 , adjustment mechanism  106  includes two spacers  110  and  112 . Preferably, these spacers have different thicknesses. These thicknesses, for example, can be selected from a group with one or two millimeter increments, such as 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, etc. 
     Looking now to  FIG. 4 , an alternate femoral ball assembly  120  is shown and includes a head  122 , a neck  124 , and an adjustment mechanism  126 . Head  122  and neck  124  are identical to head  50  and neck  52  described in connection with  FIGS. 1 and 2 . In  FIG. 3 , adjustment mechanism  126  includes three spacers  130 ,  132 , and  134 . Preferably, these spacers have different thicknesses. These thicknesses, for example, can be selected from a group with one or two millimeter increments, such as 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, etc. 
       FIGS. 3 and 4  offer a multitude of different offsets between the femoral head and femoral stem. These offsets depend on the number and thickness of spacers used. Further, these spacers can be used alone (i.e., one spacer placed inside the bore of the femoral head) or used in conjunction with other spacers. In the latter scenario, two, three, four, or more spacers can be stacked on top of each other and then placed in the bore of the femoral head. This stacking arrangement can provide a wide range of offsets in small increments. Looking to  FIG. 4  to illustrate an example, spacer  130  can have a thickness of 1 mm; spacer  132  can have a thickness of 2 mm; and spacer  134  can have a thickness of 4 mm. These spacers could be used, alone or in stacked combinations with each other, to have thicknesses of 0 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm. Thus, these three spacers can provide a femoral ball with 8 different offsets, assuming one offset (0 mm) uses no spacer at all. 
     One advantage of the present invention is that the number and thickness of spacers can vary to provide a multitude of offsets between the femoral head and femoral stem. As another example, four spacers could be provided to have thicknesses of 1 mm, 1 mm, 3 mm, and 6 mm. These four spacers would allow twelve different offset options (0 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, and 11 mm). This example is illustrated in  FIG. 5 . 
       FIG. 5  shows a femoral ball system  150 . System  150  includes a single neck  152 , a plurality of femoral heads  154 A,  154 B, and  154 C, and an adjustment mechanism  156  having a plurality of spacers  158 A,  158 B,  158 C, and  158 D. The neck, heads, and spacers are generally identical to the neck, head, and spacer discussed in connection with  FIGS. 1 and 2 . As one difference, the heads and spacers are offered in different sizes. Preferably, each head is sized differently, such as small, medium, and large. More specifically, a plurality of heads could be provided to have outer diameters of 22 mm, 26 mm, 28 mm, 32 mm, 38 mm, and 44 mm. Further, the spacers can be sized to maximize the number of different offsets while reducing the overall number of inventory components. One such size combination is spacers having thicknesses of 1 mm, 1 mm, 3 mm, and 6 mm. One skilled in the art will appreciate that many variations in the number and size of heads and spacers are within the scope of the invention. 
       FIG. 6  shows another embodiment of a femoral ball assembly  200  that includes a head  202 , a neck  204 , and an adjustment mechanism  206 . Head  202  and neck  204  are generally similar to head  50  and neck  52  described in connection with  FIGS. 1 and 2 . In  FIG. 3 , adjustment mechanism  206  includes a biasing member  210  that is adapted to be placed into the threaded bore  212  of head  202 . Biasing member  210  is shown as a coiled spring, but one skilled in the art will appreciate that many types of biasing members are also available. 
     During use, the biasing member  210  is placed in bore  212 , and then neck  204  is threadably engaged with head  202 . As the neck screws into the bore, the biasing member provides a greater and greater force against the neck. In turn, the torque required to screw the neck increases as it threads into the bore. In one embodiment, this torque can be calibrated to specific offset values. In other words, specific torque values can correspond to specific offsets. In another embodiment, indicia or a plurality of calibration marks  220  can be placed on the surface of the neck. Preferably these marks correspond to distinct, finite offsets. Markings could be given to illustrate five different offsets in 4 mm increments, such as −4 mm, 0 mm, +4 mm, +8 mm, and +12 mm. One skilled in the art will appreciate that various indicia can be used to illustrate various offsets. 
       FIG. 7  shows another embodiment of a femoral ball assembly  300  that includes a head  302 , a neck  304 , and an adjustment mechanism  306 . Neck  304  and adjustment mechanism  306  are identical to the head and adjustment mechanism discussed in connection with  FIGS. 1-4 . Head  302  is similar to the head  50  discussed in connection with  FIGS. 1 and 2  with one important difference: Head  302  is eccentric. More specifically, the body of head  302  has a central axis  310  that passes through the center of the body. The body also has a second or eccentric axis  312  that is parallel to the central axis and passes through the center of threaded bore  314 . The center of bore  314  is thus offset or eccentric with the central axis  310  of the body. As shown, the center of spacers  320  and  322  and neck  304  are concentric with bore  314 . 
     The embodiment in  FIG. 7  is advantageous because the neck  304  is eccentric or offset from the head  302 . This eccentric neck provides an increase range of motion once connected to the femoral hip stem  10  ( FIG. 1 ). This increase in range of motion more fully emulates the anatomical movements of a natural hip. Additionally, this increase in range of motion provides more joint stability to the implanted prosthesis. As yet another advantage, the eccentric neck provides a femoral hip prosthesis that is less likely to experience impingement, subluxation, or even dislocation. 
       FIGS. 8 and 9  show another embodiment of a femoral ball assembly  400  that includes a head  402 , a neck  404 , and an adjustment mechanism  406 . Head  402  is identical to the head  50  discussed in connection with  FIGS. 1 and 2 . Neck  404  is similar to the neck  52  discussed in connection with  FIGS. 1 and 2  with one important difference: Neck  404  includes a collar or shoulder  407  at first end  408 . This collar has a circular or ring-shape and extends outwardly from an outer surface  410  of neck  404 . 
     The adjustment mechanism  406  accomplishes a similar function to the adjustment mechanism  54  discussed in connection with  FIGS. 1 and 2 , but the function is performed in a different way. More specifically, the adjustment mechanism  406  includes a plurality of spacers  412  and  414 . These spacers have a ring-shape or C-clip shape. Unlike spacer  80  in  FIGS. 1 and 2 , spacers  412  and  414  are not adapted to fit inside bore  420  of head  402 . Instead, spacers  412  and  414  are adapted to fit around the second end  424  of neck  404 . As best shown in  FIG. 9 , the spacers extend through second end until they abut against collar  407 . 
     Adjustment mechanism  406  is adapted to vary the effective length of neck  404 . As discussed in connection with  FIGS. 1 and 2 , the adjustment mechanism is further adapted to provide a variable offset between the femoral head and femoral stem. As shown in  FIG. 9 , the effective length of the neck is increased by a distance “D” equal to the thickness of spacer  412  plus the thickness of spacer  414 . These spacers may have equal thicknesses or unequal thicknesses. 
       FIGS. 8 and 9  show the spacers with a C-clip shape. One skilled in the art will appreciate that other configurations are within the scope of the invention. By way of example, these configurations include a full ring-shape or retaining ring shape. 
       FIG. 10  shows another embodiment of a femoral ball assembly  500  that includes a head  502  and a neck  504 . The head  502  and neck  504  are similarly configured to the head  50  and neck  52  of  FIGS. 1 and 2  with several important differences. First, femoral ball assembly  500  does not include a separate adjustment mechanism. Bore  506  has an internally threaded wall that extends along the entire depth of the bore. The neck can thread along the entire length of the bore. Thus, the length of the neck can be varied a distance “D” approximately equal to the depth of the bore. Further, indicia or a plurality of calibration marks  510  can be placed on the outer surface of the neck. Preferably these marks correspond to distinct, finite offsets that the surgeon can view and read during a surgical procedure. Markings could be given to illustrate five different offsets in 4 mm increments, such as −4 mm, 0 mm, +4 mm, +8 mm, and +12 mm. One skilled in the art will appreciate that various indicia can be used to illustrate various offsets and increments. 
     In order to prevent, the neck from loosening once a desired offset is chosen, a locking mechanism can be used to prevent relative rotational motion between the neck and head. 
     The femoral head assembly of the present invention may be manufactured of a wide array of biocompatible materials that are known in the art. These materials include ceramics, stainless steel, titanium, and cobalt chrome alloys. Further, the adjustment mechanism may be manufactured from a broader range of materials, such as various elastomers known in the art. Preferably, such an elastomer has a well defined, controlled, and reproducible Poisson&#39;s ratio that can be used to adjust and monitor the femoral offset by tightening or loosening the neck to a given load or torque level. 
       FIGS. 1-9  illustrate a femoral ball assembly wherein the head, neck, and adjustment mechanism are separate components that are removeably connectable to each other. Other embodiments are within the scope of the invention. For example, the adjustment mechanism could be permanently connected to the neck or head. Further, the components can be configured to not be removeable from each other once they are connected. Further yet, the invention can utilize various locking mechanisms to keep or maintain the neck within the head and prevent any unintentional loosening. 
     Although illustrative embodiments have been shown and described, a wide range of modifications, changes, and substitutions is contemplated in the foregoing disclosure; and some features of the embodiments may be employed without a corresponding use of other features. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the scope of the embodiments disclosed herein.