Patent Publication Number: US-2023142406-A1

Title: Device and Surgical Technique for Foot Surgery

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application claims priority on U.S. Provisional Patent Application Ser. No. 63/276,876, filed Nov. 8, 2021 and entitled Device and Surgical Technique for Foot Surgery, and U.S. Provisional Patent Application Ser. No. 63/309,858, filed on Feb. 14, 2022 and entitled Device and Surgical Technique for Foot Surgery, the entirety of both of which are hereby incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates in general to the field of surgery. More particularly, the present invention relates to an orthopedic implant, surgical instruments for use and delivery of the implant, surgical instruments for creation of an osteotomy and/or joint fusion, and the surgical technique used with these items. Even more specifically, the present invention is directed to a corrective clamp device used during a surgical procedure. Additionally, the invention includes some or all of the following plus their combination: a correction clamp, one or more Pins, a screwdriver, one or more orthopedic implants, a drill bit, one or more tissue retractors, and a kit or kits for maintaining the components sterile. In addition, the invention also includes a method of use of the devices in a surgical procedure. 
     2. Discussion of the Related Art 
     An osteotomy and/or joint fusion is a surgical procedure that involves cutting, reshaping, or removing bone. Osteotomies and/or joint fusions are usually performed to correct a deformity in the bone. One common deformity that can be repaired by surgery is hallux valgus, also known as a bunion. Hallux valgus is a foot deformity that causes functional disability and pain and involves misalignment of the first metatarsal and phalanx. 
     Hallux Valgus can be repaired in a variety of ways; however one particular method involves structurally relocating the hallux and first metatarsal from a deformed position to its natural position. This technique is frequently called a Lapidus bunionectomy and/or first metatarsal cuneiform joint fusion, which involves manipulating the hallux and first metatarsal in multiple planes to correct the deformity, and then fixing it in place in the proper position to heal. Frequently, it is necessary to temporarily hold the hones in a corrected position, against the resistance of soft tissue, while they are fixated for permanent correction. It can be challenging for a physician to hold the deformed first metatarsal in its correct position and apply temporary fixation at the same time. 
     In addition, surgical correction frequently involves cutting bone, removing cartilage and bone, realigning or shifting the bones to the proper anatomical configuration, and then fixing the bones in the new positions such that they heal. Fixation of the bones can occur with the use of orthopedic screws, shape memory implants, or plates and screws. The surgery frequently requires incisions in the skin and soft tissues and then subsequent cutting and drilling of bone. Many conventional systems for surgery of this type require extensive dissection of soft tissue such that the physician can see the underlying bone. Extensive dissection such as this can limit or damage blood flow to the affected area and slow healing. Extensive dissection of soft tissue also risks penetrating the area around a joint, potentially permanently compromising proper joint motion. Soft tissue dissection can also damage nerves, increase swelling, or increase post-surgical pain. 
     Therefore, during surgery of this type, it is frequently an objective of the surgeon to avoid unnecessary disruption of tissue. This can be accomplished by both careful surgical techniques, as well as specially designed instruments and implants that minimize unnecessary tissue disruption. In particular, guides, tools, and other devices can assist a physician in accomplishing surgery, such as Lapidus bunionectomy, with less tissue dissection. A medical device system that is designed to assist the surgeon in minimizing unnecessary disruption of tissue can be described as “minimally or less invasive surgery”. 
     Accordingly, what is needed is a medical device system that includes instruments, implants, and a surgical technique that work together to allow motion and temporary fixation of bones while also avoiding unnecessary disruption of tissue and while producing a successful surgical outcome. For instance, what is needed is a surgical clamp that allows for an attachment to the deformed first metatarsal and a second attachment to another part of the foot, and mechanisms for moving and temporarily holding the bones while the surgeon completes the procedure. What is further needed are medical devices and processes that solves the problem outlined above associated with large incisions and variable surgical results. What is further needed is an apparatus and method of use resulting in less soft tissue disruption and providing specific guided steps for the surgery. What is also needed is a corrective clamp or other device that allows for simplified, corrective reduction of the deformity and fixation of bones relative to one another. The corrective clamp allows surgeons to correct deformity in multiple planes and hold the position while permanent fixation is applied. The corrective clamp also allows surgeons to complete this without any incisions and in a timely fashion in comparison to other corrective devices of the prior art. 
     SUMMARY AND OBJECTS OF THE INVENTION 
     In accordance with a first aspect of the invention, a correction clamp assembly is provided that allows for the manipulation of first and second pieces of bone relative to one another while creating an osteotomy and/or joint fusion. The assembly includes an elongate bridge, a first block, a second block, and a plurality of pins. The elongate bridge includes a body, a first opening formed in the body, and a slot extending along and through a portion of the body. The first block is slidably and rotatably connected to the elongate bridge, for instance about the slot. The second block is rotatably connect to the elongate bridge, for instance about the first opening. The plurality of pins may include a first pin associated with the first block and a second pin associated with the second block. Additionally, the assembly may include at least one first block locking screw that is configured to releasably secure the first block relative to the elongate bridge in a lateral and rotational direction, as well as at least one second block locking screw that is configured to releasably secure the second block relative to the elongate bridge in a rotational direction. The first block may further include at least one guide rail that is configured to guide movement of the first block relative to the elongate bridge. 
     According to another aspect of the invention, the first pin is configured to be secured to a first metatarsal and the second pin is configured to be secured to a second metatarsal. The second pin may be configured to be manipulated in order to move the first metatarsal towards the second metatarsal. 
     According to yet another aspect of the present invention, the first block further comprises a main body, a tube with a first opening extending therethrough along a first axis, and a second opening extending through the body along a second axis. The second opening may be configured to receive at least one locking screw. Additionally, the second block further comprises a main body, a tube with a first opening extending therethrough along a first axis, and a second opening extending through the body along a second axis. Again, the second opening may be configured to receive at least one locking screw. 
     According to another aspect of the invention, the first block may also include a gripping section and an identifier. Similarly, the second block may include a gripping section and an identifier. Further still, the elongate bridge includes first and second identifiers. The first block identifier may be aligned with the first identifier of the elongate bridge, whereas the second block identifier may be aligned with the second identifier of the elongate bridge. This helps to expedite alignment and assembly of the correction clamp. 
     According to yet another aspect of the present invention, a method of performing a medical procedure is provided. The method includes the steps of inserting a first pin through a second metatarsal, inserting the first pin through a first block associated with a correction clamp, inserting a second pin through a first metatarsal, and inserting the second pin through a second block associated with the correction clamp. Additionally, the method may include creating a corrective cut or joint fusion position in one or more of a bone and a joint, after which the second pin may be manipulated in order to move the second block and the first metatarsal relative to the second metatarsal, for instance by pressing or pinching the second pin towards the first pin. Once a desired location is reached, the first metatarsal may be secured in place. Further, the method may include the steps of sliding the first block relative to a bridge associated with the correction clamp, and rotating the second block relative to the bridge. For instance, the first block may be slid relative to a slot formed in the bridge, while the second block may be rotated relative to a hole formed in the bridge. Additionally, the method may include sliding at least one guide rail associated with the first block to enable movement of the first block relative to the bridge. Also, the first block may be secured in place relative to the bridge using a first locking screw, whereas the second block may be secured in place relative to the bridge using a second locking screw. The method may also include the step of inserting the first pin through an opening in a tube that extends through the first block, and inserting the second pin through an opening in a tube that extends through the second block. 
     According to yet another aspect of the present invention, a kit for an osteotomy medical procedure is provided that includes a bridge having a body, a first opening formed in the body, and an elongate slot formed in the body, a first block configured to be secured to the bridge along the slot, and a second block configured to be secured to the bridge about the first opening, as well as a plurality of pins. The kit may also include a plurality of locking screws that are configured to releasably secure the first block and the second block in place relative to the bridge. Additionally the kit may include a cutting saw for creating a corrective cut or joint fusion in one or more of a bone and a joint, as well as a screw configured to secure a portion of the bone in place. 
     These, and other aspects and objects of the present invention will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following description, while indicating preferred embodiments of the present invention, is given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the present invention without departing from the spirit thereof; and the invention includes all such modifications. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A clear conception of the advantages and features constituting the present invention, and of the construction and operation of typical mechanisms provided with the present invention, will become more readily apparent by referring to the exemplary, and therefore non-limiting, embodiments illustrated in the drawings accompanying and forming a part of this specification, wherein like reference numerals designate the same elements in the several views, and in which: 
         FIG.  1    is a top plan view of the bones of a foot with a bunion deformity; 
         FIG.  2    is a top plan view of the bones of a foot with normal anatomy; 
         FIG.  3    is an isometric view of an inventive correction clamp device with pins extending therethrough; 
         FIG.  4    is an isometric view of the correction clamp with pins of  FIG.  3   ; 
         FIG.  5    is a left side elevation view of the correction clamp with pins of  FIGS.  3  and  4   ; 
         FIG.  6    is a right side elevation view of the correction clamp with pins of  FIGS.  3 - 5   ; 
         FIG.  7    is a top plan view of the correction clamp with pins of  FIGS.  3 - 6   ; 
         FIG.  8    is a bottom plan view of the correction clamp with pins of  FIGS.  3 - 7   ; 
         FIG.  9    is a front end elevation view of the correction clamp with pins of  FIGS.  3 - 8   ; 
         FIG.  10    is a rear end elevation view of the correction clamp with pins of  FIGS.  3 - 9   ; 
         FIG.  11    is an isometric view of a bridge of the correction clamp of  FIGS.  3 - 10   ; 
         FIG.  12    is an isometric view of a first block of the correction clamp of  FIGS.  3 - 10   ; 
         FIG.  13    is an isometric view of a second block of the correction clamp of  FIGS.  3 - 10   ; 
         FIG.  14    is a perspective view of a first embodiment of the correction clamp positioned over a first and second metatarsal; 
         FIG.  15    is a left side elevation view of a foot with a bunion deformity, with the first embodiment of the correction clamp positioned over first and second metatarsal; 
         FIG.  16    is a right side elevation view of a foot with a bunion deformity, with the first embodiment of the correction clamp positioned over first and second metatarsal; 
         FIG.  17    is a perspective view of the first embodiment of the correction clamp positioned over a foot; 
         FIG.  18    is an isometric end view of the first embodiment of the correction clamp positioned over the first metatarsal and foot; 
         FIG.  19    is an isometric view of a foot with a bunion deformity, with the correction clamp and pins in position, before correction of the deformity; 
         FIG.  20    is an isometric view of a foot with the first metatarsal being manipulated with the correction clamp to begin the correction of the bunion deformity; 
         FIG.  21    is an isometric view of a foot with the first metatarsal being shifted towards the second metatarsal using the correction clamp to correct the bunion deformity; and 
         FIG.  22    is an isometric view of a foot with the correction clamp in place and the first pin being rotated towards the second pin such that the bunion deformity is fully corrected. 
     
    
    
     In describing the preferred embodiment of the invention which is illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose. For example, the word connected, attached, or terms similar thereto are often used. They are not limited to direct connection but include connection through other elements where such connection is recognized as being equivalent by those skilled in the art. 
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     The present invention and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments described in detail in the following description. Initially, a variety of tools will be described, after which use of the tools together will be described to perform the desired medical procedure. Preferably, the described system can be used to streamline and simplify minimally invasive surgical procedures. Additionally, the described system preferably results in better cosmetic results, such as less scarring, decreased trauma to the soft tissues, less damage to blood supply, faster healing, less time in the operating room for the patient and physicians, less post-operative pain, swelling, and complications, and/or quicker recovery time and earlier return to activities. While the description below will primarily be in relation to surgical procedures designed to correct issues relating to hallux valgus/bunions, the present invention could similarly be used to correct other issues in a patient&#39;s feet, ankles, and elsewhere on the body. 
     Turning initially to  FIG.  1   , a foot  20  with a bunion deformity that requires surgical correction is illustrated, whereas  FIG.  2    shows a normal foot with no deformity. The feet  20  in both  FIGS.  1  and  2    show a second metatarsal  28  that has no or minimal deformity. As seen in  FIG.  1   , the first metatarsal  22  is deformed in multiple planes. Additionally, the medial cuneiform  24  and the proximal phalanx  26  are also deformed due to their attachment to the first metatarsal  22 . When the present invention is used to surgically correct the foot shown in  FIG.  1   , the first metatarsal  22  will be substantially repositioned as it is shown in  FIG.  2    into a normal anatomic position. As a result, the medial cuneiform  24  and the proximal phalanx  26  are also in the proper anatomic position. 
     Moving generally to  FIGS.  3 - 13   , the inventive correction clamp  30  and associated components such as a first installed pin  32  and a second installed pin  34 , are illustrated. This inventive correction clamp  30  is used to remedy the bunion deformity shown in  FIG.  1   , after which the foot will be surgically corrected to look substantially more anatomic as it does in  FIG.  2    as will further be described. 
     The correction clamp  30  consists of three main pieces: a first block  36 , a second block  38 , and a bridge  40 . Each of these are shown assembled in  FIGS.  3 - 10   , and in isolation in  FIGS.  11 - 13   . Advantageously, each of the first block  36 , the second block  38 , and the bridge  40  are relatively simple parts have few components that can be installed and manipulated relative to one another, and can also be affordably manufactured. While exemplary embodiments of these components are shown in the figures, these components could take virtually any shape or size while functioning as described here. Further, while features of these components are described below, each of these components could include additional or fewer components depending on any number of different factors. 
     Turning to  FIG.  12   , the first block  36  includes a body  42  that has a tube  44  with a pin hole opening  46  formed therein that extends through the length of the tube  44 . The tube  44  and the pin hole opening  46  extend along a first axis, which will be described herein as a substantially vertical axis based on how it is shown in  FIG.  12   , but of course the first block  36 , as well as the clamp  30 , could be oriented in any direction when in use. A screw hole opening  48  also extends through the body  42  of the first block  36 , with the screw hole opening  48  extending along a second axis that is substantially perpendicular relative to the first axis. As shown, the second axis is substantially horizontal, such that the screw hole opening  48  extends in the horizontal direction. 
     The tube  44  is configured to receive the first pin  32  through the pin hole opening  46 . The first pin  32  can move freely through the tube  44 , otherwise, it can be locked into place, for instance using a locking screw  50  that can be inserted into the screw hole opening  48 , after which it can be twisted to either release the first pin  32  or hold it in place. 
     Additionally, top and bottom guide rails  52 ,  54  are provided that extend from the body  42  of the first block  36 . Again, use of the words “top” and “bottom” are used relative to what is shown in  FIG.  12   , although the components could be used in other orientations. These guide rails  52 ,  54  are configured to secure the first block  36  to the bridge  40  and enable movement of the first block  36  relative to the bridge  40  as will further be described below. 
     Further still, the first block  36  may include a grip section  56 , which can be engaged by a user&#39;s fingers. The grip section  56  includes a tab  58 , as well as a textured portion  60  that can be easily gripped by and manipulated by a user during a medical procedure. Further still, the first block  36  may include an identifier  62 , here the number “3”, which helps users identifying the relevant parts and assembly and/or use of the correction clamp  30 . The first block  36  may not include an identifier in other embodiments. 
     Next, the second block  38  will be described. The second block  38  includes a body  64  that has a tube  66  with a pin hole opening  68  formed therein that extends through the length of the tube  66 . The tube  66  and the pin hole opening  68  extend along a first axis, which will be described herein as a substantially vertical axis based on how it is shown in  FIG.  13   , but of course the second block  38 , as well as the clamp  30 , could be oriented in any direction when in use. A screw hole opening  70  also extends through the body  64  of the second block  38 , with the screw hole opening  70  extending along a second axis that is substantially perpendicular relative to the first axis. As shown, the second axis is substantially horizontal, such that the screw hole opening  70  extends in the horizontal direction. 
     The tube  66  is configured to receive the second pin  34  through the pin hole opening  68 . The second pin  34  can move freely through the tube  66 , otherwise, it can be locked into place, for instance using a locking screw  72  that can be inserted into the screw hole opening  70 , after which it can be twisted to either release the second pin  34  or hold it in place. 
     Additionally, the second block  38  may include a grip section  74  including a textured portion  76 , which can be engaged by a user&#39;s forgers. Further still, the second block  38  may include an identifier  78 , here the number “4”, which helps users in terms of identifying the relevant parts and assembly and/or use of the correction clamp  30 . The second block  38  may not include an identifier in other embodiments. 
     Next, the bridge  40  will be described. The bridge  40  includes an elongate body  78 . Within the elongate body  78 , a slot  80  is shown that extends along a majority of the elongate body  78  from a first end  82  toward a second end  84 . The slot  80  allows the first block  36  to be translated towards and away relative to the second block  38  as will be further described below. Additionally, a bridge hole  86  is formed in the second end  84 , with a portion of the elongate body  78  separating the bridge hole  86  from the slot  80 . Both the slot  80  and the bridge hole  86  are sized to receive additional locking screws  88 ,  90 , as again will further be described below. Further still, the bridge  40  may include a grip section  92  that can be used in conjunction with the grip section  74  of the second block  38  in order to manipulate the various pieces relative to one another as will further be described below. Further still, the bridge  40  may include one or more identifiers  94 ,  96 , here the numbers “1” and “2”, which helps users in terms of identifying the relevant parts and assembly and/or use of the correction clamp  30 . In other embodiments, the identifiers may be inverted, with identifier  94  being directed to “2” and identifier  96  being “1”. In other embodiments the bridge  90  may not include identifiers at all. Further, the bridge  40  may include an upper lip  98  and a lower lip  100  extending from a front face  102  of the bridge  40 . Additionally, channel  104  may be located in the bottom of the bridge  40 , which in turn forms the lower lip  100 . The upper lip  98  and lower lip  100  are dimensioned such that the top guide rail  52  and the bottom guide rail  54  are configured to engage with, and slide along, these lips  98 ,  100 . 
     As described above, the correction clamp  30  includes a plurality of locking screws, as seen, four locking screws  50 ,  72 ,  88 ,  90 . Each of these locking screws  50 ,  72 ,  88 ,  90  are illustrated to be substantially the same, although of course screws having different diameters or operating characteristics could be similarly used. Furthermore, other fasteners configured to releasably attach the various components to one another could similarly be employed. 
     Whether the illustrated locking screws  50 ,  72 ,  88 ,  90  are used, or other fasteners are, these components allow the first block  36  to be locked and released from translating and/or rotating relative to the bridge  40 , and allow the second block  38  to be locked and released from rotating relative to the bridge  40 . More specifically, a user of the correction clamp  30  can push or pull on the first block  36  and the second block  38  to translate the first block  36 . Once the blocks  36 ,  38  and associated pins  32 ,  34  reach a desired location, the locking screws  50 ,  72 ,  88 ,  90  may be tightened in order to hold the first block  36  in place. Thereafter, the locking screws  50 ,  72 ,  88 ,  90  can be loosened to release the first block  36  and allow it to translate. Additionally, the first block  36  and second block  38  are able to rotate relative to the bridge  40 . More specifically, locking screws  50 ,  72 ,  88 ,  90  may be tightened or loosed to prevent or enable rotation of the first block  36  or the second block  38 . 
     Additionally, the first block  36  and the second block  38  are both slidably attached to the bridge  40 . The bridge  40  may be ratcheted, ridged, or have other features to allow sliding and then locking in place of the first block  36  and the second block  38 . The bridge  40  can extend past the first block  36  and the second block  20  if desired or needed. A release button (not shown) or other quick release feature may be used to release the bridge  30  so that it moves freely into the first block  36  or the second block  38 , for example if the bridge  40  is ratcheted. 
     Turning next to  FIGS.  3 - 10   , various views are provided of the correction clamp  30 , with the first pin  32  and the second pin installed  34  installed. As will be appreciated by one having ordinary skill in the art, the first block  36  can be translated in the slot  80  of the bridge  40 . In these figures, the first pin  32  is shown rotated at an angle of approximately 30-degrees relative to the second pin  34 . The design of first block  36  and the second block  38  is such that the first pin  32  and the second pin  34  can each be rotated to any desired position. 
     Next,  FIGS.  14 - 22    show how the correction clamp  30  would be used in surgery on a right foot. The correction clamp  30  could also be made to be suitable for both feet, or with separate right-foot and left-foot versions. These figures show a foot  20  with a first metatarsal  22  and a second metatarsal  28 . The correction clamp  30  is shown positioned in place in different views. In the illustrated embodiment, the second block  38  is positioned over the second metatarsal  28 , and the second pin  34  is oriented approximately perpendicular to the foot  20  and passes through the second block  38  into the second metatarsal  28 . Additionally, the first block  36  is positioned over the first metatarsal  100 , and the first pin  32  is angled at approximately 30 degrees relative to the vertical. The first pin  32  passes through the first block  36  and into the first metatarsal  22 . In this way, the first pin  32  is configured to allow for rotation of the first metatarsal  22  in the frontal plane. Alternatively, the second block  38  can attach to other undeformed bones of the foot, such as the lesser toe metatarsals or another location, depending on designer and physician preference. Of course, the bridge  40  could be longer than what is shown in the figures when the correction clamp  30  is used with other bones of the foot. 
     The correction clamp  30  is configured to have the first block  36  attach to an undeformed portion of the foot such as the second metatarsal  28 , while second block  38  attaches to a deformed portion of the foot such as the first metatarsal  22 , and then allow the first metatarsal  22  to be manipulated by the physician into its proper anatomic location while the correction clamp  30  moves to accommodate this repositioning. The locking screws  50 ,  72 ,  88 ,  90  can be tightened and loosened as needed to allow for appropriate degrees of freedom. 
       FIGS.  19 - 22    provide an isometric view of the successive steps of the surgical procedure. First, in  FIG.  19   , the corrective clamp  30  is positioned on the foot  20 , with the second pin  34  in the first metatarsal  22  and the first pin  32  in the second metatarsal  28 . The surgeon then prepares the first metatarso-cuneiform joint, after which the first metatarsal  22  can be positioned and rotated freely relative to the second metatarsal  28 . 
     Next,  FIG.  20    shows the first metatarsal  22  now being straightened to eliminate part of a deformity. The corrective clamp  30  allows second block  38  to be translated away from the first block  36 , after the locking screws  72 ,  90  have been loosened to enable movement. 
     In  FIG.  21   , the first metatarsal  22  can now be moved into proper anatomical location by pressing the second block  38  towards the first block  36 . The first block  36  moves along the bridge  40  in the slot  80 . When the first block  36  has moved the desired distance, the locking screws  50  can be tightened to hold the first block  36  in place, and thus hold the first metatarsal  22  in its new position. 
       FIG.  22    shows that one of the locking screw  90  has now been loosened, with the other locking screw  88  remaining tight. Loosening the locking screw  90  allows the second pin  34  to be rotated relative to first pin  32 . Since the second pin  34  passes into the first metatarsal  22 , in this way the first metatarsal  22  is also rotated relative to the second metatarsal  24 . The locking screw  90  can be tightened when the desired correction is achieved. 
     The steps described above and shown in  FIGS.  19 - 22    can be iterated any number of times, to properly position the two metatarsals. The locking screws  50 ,  72 ,  88 ,  90  can be loosened and tightened as needed, to allow for relative motion of the two metatarsals. The corrective clamp  30  is capable of correcting the abnormal metatarsal/foot deformity and holding the two metatarsals in the corrected position until the surgeon places permanent fixation. 
     The correction clamp  30  and associated components can be packaged together with a first pin  32  and a second pin  34 , as well as other instruments in a surgical kit. The kit can be presented in the operating room as a pre-sterilized kit, or non-sterile. The kit can include common fixation mechanisms such as nitinol staple, orthopedic screws, or a plate with screws. 
     Although the best mode contemplated by the inventors of carrying out the present invention is disclosed above, practice of the present invention is not limited thereto. It will be manifest that various additions, modifications and rearrangements of the features of the present invention may be made without deviating from the spirit and scope of the underlying inventive concept. For example, any of the specific aspects of any of the described embodiments could similarly be used with any of the other embodiments. Furthermore, while specific materials have been described, it should be known that any materials could used to create any of the described drapes. For instance, materials may be chosen based on any number of criteria, including costs, availability, and various sterility properties. Moreover, as described above, the individual components need not be formed in the disclosed shapes, or assembled in the disclosed configuration, but could be provided in virtually any shape, and assembled in virtually any configuration. Further, any of the components can be manufactured with one another or be separately manufactured and later assembled. Furthermore, all the disclosed features of each disclosed embodiment can be combined with, or substituted for, the disclosed features of every other disclosed embodiment except where such features are mutually exclusive. Figures are not to scale, and some features are exaggerated to show details of particular features or method steps. Further still, some of the tools described above may be reusable, while others may be disposable. 
     It is intended that the appended claims cover all such additions, modifications and rearrangements. Expedient embodiments of the present invention are differentiated by the appended claims.