Abstract:
Embodiments of the present disclosure relate to apparatuses, systems, and methods for safely delivering and deploying an intravascular device. An apparatus for controlling an intravascular device may include a body having rotating assembly disposed through the body. The rotating assembly may be configured to hold a proximal end of an elongate mandrel. The rotating assembly may be rotationally connected to the body by a one-way bearing.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     N/A 
     BACKGROUND OF THE DISCLOSURE 
     1. The Field of the Invention 
     Generally, this disclosure relates to medical devices. Specifically, the present disclosure relates to intravascular devices. Even more specifically, present disclosure relates to the reliable control and deployment of intravascular devices. 
     2. Background and Relevant Art 
     Intravascular devices grant medical professionals the ability and option to perform healing procedures within a patient while avoiding more complicated, higher risk, and more expensive invasion procedures. The ability to access, for example, the heart through the femoral artery allows a medical profession to avoid open surgery and can save the patient days or weeks of recovery time. Open surgery carries with it potential complications. Open surgery can be take more time, require more personnel, lead to greater blood loss, and carry a greater infection risk during the procedure. 
     Additionally, the recovery period for open surgery carries significant downsides, as well. Any surgical opening requires time to healing upon closure. The healing time is longer for a larger opening. Larger openings may also carry with them a greater risk of infection during the healing process. The larger surface area that may become infection is an additional challenge, but the longer time period also creates problems as patients typically become less vigilant about maintaining the sterility and cleanliness of their sutures, staples, or other closures as time progresses. 
     Because intravascular procedures carry benefits over open surgery, they are used in increasing numbers. Intravascular procedures are also used to provide care to patients who may not be optimal candidates for open surgeries due to age or other medical concerns. Therefore, access to a variety of procedures is desirable. Consequentially, intravascular procedures may include the insertion and subsequent removal of intravascular devices or may include the placement of a device to remain in the patient&#39;s body, either temporarily or permanently. Both the incorrect or incomplete placement of an intravascular device, as well as the premature deployment of an intravascular device can cause significant complications. Incorrect, incomplete, or premature deployment may dictate a subsequent open surgery to retrieve or repair the intravascular device and even in a patient previously determined to be a non-ideal candidate for open surgery. 
     BRIEF SUMMARY 
     Embodiments of the present disclosure address one or more of the foregoing or other problems in the art with apparatuses, systems, and methods for more reliably controlling and deploying intravascular devices. 
     In a non-limiting embodiment, an apparatus for controlling an intravascular device includes a body containing a rotating assembly configured to hold an end of an elongated mandrel. The rotating assembly is rotationally connected to the body by a one-way bearing located between the rotating assembly and the body. The rotating assembly is rotated by an actuator knob. The one-way bearing allows the transmission of a rotational force from the rotating assembly to the elongate mandrel in one direction. The one-way bearing prevents the transmission of a rotational force from the body to the elongate mandrel in an opposite rotational direction. 
     In another non-limiting embodiment, a method of manufacture for an apparatus for controlling an intravascular device includes affixing an elongate mandrel within a rotating assembly. A one-way bearing is affixed inside a threaded insert. The threaded insert is threaded into a bore by applying torque in a locking direction of the one-way bearing. At least part of the rotating assembly is affixed within the one-way bearing. 
     In yet another non-limiting embodiment, an intravascular device delivery system includes an elongate mandrel with a proximal end and rotatable fastener at a distal end. An intravascular device is fastened to the rotatable fastener. The proximal end of the elongate mandrel is held by a rotating assembly in a controller. The controller includes a body in which the rotating assembly is located. An actuator knob is configured to rotate the rotating assembly relative to the body. The rotating assembly is connected to the body via a one-way bearing located between the rotating assembly and the body. 
     Additional features and advantages of embodiments of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such embodiments. The features and advantages of such embodiments may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims, or may be learned by the practice of such embodiments as set forth hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In order to describe the manner in which the above-recited and other advantages and features of the disclosure can be obtained, a more particular description of the disclosure briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. For better understanding, the like elements have been designated by like reference numbers throughout the various accompanying figures. While some of the drawings are schematic representations, at least some of the figures may be drawn to scale. Understanding that these drawings depict only embodiments of the disclosure and are not therefore to be considered to be limiting of its scope, the disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  illustrates an intravascular device delivery system according to the present disclosure; 
         FIG. 2  illustrates a detail view of a controller including a one-way actuator knob; 
         FIG. 3  illustrates a cross-sectional side view of a controller including a one-way actuator knob; 
         FIG. 4  illustrates an exploded cross-sectional side view of an actuator slider and one-way actuator knob; 
         FIG. 5  schematically illustrates a one-way actuator knob transferring torque to the body of the controller; 
         FIG. 6  schematically illustrates a one-way actuator knob allowing rotation of the knob without transferring torque to the body of the controller; 
         FIG. 7  illustrates a cross-sectional side view of a rotating assembly; 
         FIG. 8  illustrates the mounting of a one-way bearing in a controller; and 
         FIG. 9  illustrates the assembly of a controller according to the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     One or more embodiments of the present disclosure relate to controlling and deploying intravascular devices. 
     An intravascular device may be controlled and deployed by a controller operated by a medical profession outside the patient&#39;s vasculature. The controller may allow for the actuation of various components of the intravascular device and may allow the placement of the intravascular device. The placement of the device may include rotational and longitudinal placement in a vessel. Rotational placement may be effected by the translational of torque from the controller to the intravascular device. An elongate mandrel may connect the controller to the intravascular device and transmit longitudinal force and torque therebetween. The controller may include a rotatable actuator knob that may disconnect the intravascular device from the elongate mandrel. 
     The actuator knob may disconnect the intravascular device from the elongate mandrel when the actuator knob, and hence the elongate mandrel, is rotated in a counter clockwise direction. However, when rotated in the clockwise direction, the actuator knob, and hence the elongate mandrel, may damage the connection between the elongate mandrel and the intravascular device. A one-way bearing located between a body of the controller and a rotating assembly inside the controller may substantially limit the ability of the actuator knob to rotate in the clockwise direction and damage the connection between the elongate mandrel and the intravascular device. The one-way bearing may allow the rotation of the elongate mandrel without any perceivable interference to a user in a first direction. The one-way bearing may transmit torque from the actuator knob to the body of the controller, and hence the user&#39;s grip on the controller, when rotated in an opposite second direction. An incorrectly assembled controller may substantially inhibit counter clockwise rotation of the actuator knob and, hence, a medical professional&#39;s ability to disconnect and deploy an intravascular device. A method of manufacture is also presented herein to ensure correct directional assembly of a controller. 
       FIG. 1  depicts an intravascular device delivery system  100  including a controller  102 , an elongate mandrel  104 , and an intravascular device  106 . The controller  102  may be connected to a proximal end of the elongate mandrel  104  and the intravascular device  106  may be connected to a distal end of the elongate mandrel  104 . The intravascular device  106  may include a variety of devices and is depicted schematically. In some embodiments, the intravascular device  106  may include a mitral valve repair device, such as a MITRACLIP available from Abbott Vascular. In other embodiments, the intravascular device  106  may include other vascular repair devices. In yet other embodiments, the intravascular device  106  may include filtration devices. In further embodiments, the intravascular device  106  may include pharmaceutical eluting devices. In some embodiments, the elongate mandrel  104  may connect to the intravascular device  106  by an internal threaded connection, an external threaded connection, a bayonet connection, other suitable rotational connection, or combinations thereof. 
     The elongate mandrel  104  may include a catheter, guidewire, other vascular sleeve, or combinations thereof. In some embodiments, the elongate mandrel  104  may have a working length less than about 1000 mm in length, greater than about 1000 mm in length, greater than about 1200 mm in length, or about 1220 mm in length. As used herein, “working length” should be understood to be the effective, usable length of a component or device during a medical procedure. For example, total length of the elongate mandrel  104  may be greater than the working length of the elongate mandrel  104  as portions of the elongate mandrel may be contained within other components, such as the intravascular device  106  or the controller  102 . 
     The controller  102  is located at a distal end of the elongate mandrel  104 . The controller  102  may include a variety of buttons  108  in order to control various functions or conditions of the intravascular device  106 , pressure system (e.g. a bleedback valve) and/or a delivery mechanism. In the depicted embodiment, the controller  102  may include an arm positioner knob  110  for manipulating the arm positions of a mitral valve repair device. Actuator knob  112  is located at the proximal end of the controller  102 . The rotation of the actuation knob  112  may be restricted by an actuator clip  114 . The actuator clip  114  rotationally fixes a position of the actuator knob  112  relative to a controller body  116 . The actuator clip  114  may be removed when rotation of the actuator knob  112 , hence deployment of the intravascular device  106  is intended. 
       FIG. 2  illustrates a detail view of the controller  102  and actuator knob  112  with the actuator clip  114  removed. The actuator knob  112  may be fixed to a threaded rod  118  that is inserted and threaded into a crimping cam  120  (visible in  FIG. 3 ). The actuator knob  112  may thereby rotate the crimping cam  120  via torque transmitted by the threaded rod  118 . The crimping cam  120  may rotate relative to the controller body  116  when the actuator clip  114  is removed from the crimping cam  120 . 
       FIG. 3  shows a cross-sectional view of the controller  102  depicted in  FIG. 2 . As described, the actuator knob  112  may be fixed to a threaded rod  118 , which is threaded into the crimping cam  120 . The crimping cam  120  may include within it a collet  122 . In some embodiments, the crimping cam  120  may be generally cylindrical, for example, having a circular transverse cross-section. In other embodiments, the interior surface  124  of the crimping cam  120  may have a polygonal transverse cross-section such a square, a pentagon, a hexagon, and similar or an irregular polygon. Similarly, in some embodiments, the collet  122  may be generally cylindrical and have a circular transverse cross-section. In other embodiments, the collet  122  may have a polygonal transverse cross-section such a square, a pentagon, a hexagon, and similar or an irregular polygon. In some embodiments, the collet  122  may mate complimentarily with an interior surface  124  of the crimping cam  120 . 
     The actuator knob  112 , threaded rod  118 , crimping cam  120 , collet  122  may share a longitudinal axis  126  about which they may all rotate. As such, the shared longitudinal axis  126  may also be a shared rotational axis. The threaded rod  118  may apply a longitudinal compression force upon the collet  122  as the threaded rod  118  is rotated against the complimentarily threaded crimping cam  120 . The compression force on the collet  122  may cause the collet to move longitudinally and strike one or more tapers  128  on the crimping cam  120 . The tapers  128  may apply a lateral compression force upon the collet  122 . The lateral compression force may, in turn, cause the collet  122  to impinge upon a proximal end  130  of the elongate mandrel  104 . 
     The collet  122  may thereby hold the proximal end  130  of the elongate mandrel  104  in within the rotating assembly  132 . The rotating assembly  132  may include the actuator knob  112 , threaded rod  118 , collet  122 , and crimping cam  120 . The rotating assembly  132  may rotate relative to the controller body  116 . In some embodiments, the rotating assembly  132  may rotate upon a one-way bearing  134  located between the rotating assembly  132  and an actuator slider  136 . The actuator slider  136  may be rotationally fixed relative to the controller body  116 . In other embodiments, the rotating assembly  132  may rotate upon a one-way bearing  134  located between the rotating assembly  132  and the controller body  116 . 
     In some embodiments, the one-way bearing  134  may be a rotational clutch bearing. In other embodiments, the one-way bearing  134  may be a ratcheting bearing. In an embodiment, the one-way bearing  134  may be an annular or cylindrical rotational bearing. The rotating assembly  132  may be rotationally fixed relative an inner surface of the one-way bearing. In various embodiments, the rotating assembly  132  and one-way bearing  134  are fixed using a friction fit, a press fit, an adhesive, a weld, other suitable attachment mechanism, or combinations thereof. A clutch bearing may freely enable rotation of the rotating assembly  132  in a first direction while allowing for nearly instant resistance to be applied when rotated in a second direction. Similarly, a ratcheting bearing may allow freely enable rotation in the first direction, but may allow some degree of backlash in the second direction. As used herein, “rotating direction” should be understood to refer to the rotational direction in which the one-way bearing  134  rotates with relatively little friction. “Locking direction” should be understood to refer to the rotational direction in which the one-way bearing  134  may resist rotation and transfer torque. The ratcheting bearing may result in a tactile “clicking” sensation during operation. In some environments, such a sensation may be undesirable due to medical professional&#39;s experience and training with other rotation systems. When changing from a rotation system such as a bi-direction actuator having a rotating inner component and stationary outer component separated only by a simple bearing surface, the change from a simple bearing surface with near constant friction to a ratcheting system may result in a foreign tactile sensation. In at least some embodiments therefore, it may be desirable to retain as much familiar tactile performance as possible to encourage adoption of embodiments incorporating a one-way bearing  134 . 
     The one-way bearing  134  may rotate freely in the “rotating direction” and “lock” when torque is applied in the “locking direction.” To help ensure the one-way bearing  134  is installed in the controller  102  in the proper orientation, a number of indicators and design structures may be employed. In an embodiment, the one-way bearing may have a visual indicator imprinted, embossed, and/or applied to a surface indicating the rotating direction. In another embodiment, the locking direction may be leveraged during the assembly process.  FIG. 4  depicts a controller  102  expanded along the longitudinal axis  126 . In some embodiments, the one-way bearing  134  is connected to the interior of a threaded insert  138 . In other embodiments, the one-way bearing  134  may have threads integrated into the one-way bearing  134 , itself. The one-way bearing  134  may be connected to the interior of a threaded insert  138  by a friction fit, a press fit, an adhesive, a weld, other suitable attachment mechanism, or combinations thereof. 
     The threaded insert  138  may use the locking direction of the affixed one-way bearing  134  to drive the threaded insert  138  into the actuator slider  136 . The threaded insert  138  may include left-hand threads  140  (opposite of the common threading direction) on a lateral surface thereof, which may mate with complimentary threads  142  on the actuator slider  136 . The locking direction of the one-way bearing  134  may therefore transfer torque to the threaded insert  138  when the one-way bearing  134  is aligned such that the locking direction is oriented in the direction of the left-hand threads  140 . The rotating direction of the one-way bearing  134  may also substantially prevent the transfer of torque to the threaded insert  138  when the one-way bearing  134  is aligned such that the rotating direction is oriented in the direction of the left-hand threads  140 . 
     The threaded insert  138  may be driven into the actuator slider  136  therefore when the locking direction of the one-way bearing  134  is oriented counter-clockwise when viewed from a distal end  144  of the controller  102 . When viewed from a proximal end  146  of the controller  102 , the locking direction of the one-way bearing  134  may be the clockwise direction. Accordingly, the rotating direction of the one-way bearing  134  may permit rotation in the counter-clockwise direction when viewed from the proximal end  146  of the controller  102 . As an operator will view the controller  102  from the proximal end  146 , the one-way bearing  134  may allow rotation of the actuator knob  112 , and hence rotating assembly  132  and elongate mandrel  104  in a counter-clockwise direction. The counter-clockwise rotation of the elongate mandrel  104  may disconnect and/or deploy the intravascular device  106  at the distal end of the elongate mandrel  104 . 
     As shown in  FIG. 5 , applying torque to the actuator knob  112  may apply a torque to the rotating assembly  132 . When the torque vector is in the distal direction (according to the right-hand rule) toward the distal end  144  of the controller  102 , the one-way bearing  134  may transmit the torque to act upon the actuator slider  136 . The actuator slider  136  may be rotationally fixed to the controller body  116 . The controller body  116  may be held by a user during operation of the actuator knob  112 . The actuator knob  112  may have a smaller radius than the controller body  116 . Therefore, the user may use comparatively little force to hold the controller body  116  still during the transmission of torque from the actuator knob  112  to the controller body  116 . This may effectively prevent substantial movement of the controller  102  during application of torque to the actuator knob  112  in the locking direction. 
     As shown in  FIG. 6 , applying torque to the actuator knob  112  toward the proximal end  146  (according to the right-hand rule) may apply torque to the rotating assembly  132 . The one-way bearing  134  may transmit little to no torque to the controller body  116  through the threaded insert  138 , thereby allowing rotation of the rotating assembly  132  about the longitudinal axis  126 . The rotation of the rotating assembly  132  about the longitudinal axis may rotate the elongate mandrel  104 . 
     The rotating assembly  132  may be connected via the one-way bearing to the controller body  116  directly or via the actuator slider  136 . The rotating assembly  132  may be “held” in place when the one-way bearing  134  transfers torque to the actuator slider  136 , which may be, in turn, held in place by the body  116 . An operator may then resist the rotation of the body manually. The rotating assembly  132  may also be connected to the controller body  116  directly via the one-way bearing  134 , such that the one-way bearing  134  transfers torque directly from the rotating assembly  132  to the controller body  116 . 
     As described in relation to  FIG. 3 , the intravascular device delivery system  100  of the present disclosure may use the mechanical characteristics of some components during a manufacturing process. As shown in  FIG. 7 , the assembly of an intravascular device delivery system  100  may include the assembly of a controller  102 . The elongate mandrel  104  may be inserted into the collet  122 . The elongate mandrel  104  may extend from a tapered end  148  of the collet  122  and the proximal end  130  of the elongate mandrel  104  may be within the collet  122 . The collet  122  may be inserted into the crimping cam  120 . In an embodiment, the crimping cam  120  may include one or more tapers  128  that compliment tapers  150  on the collet  122 . In other embodiments, the crimping cam  120  may include one or more tapers  128  that do not compliment tapers  150  on the collet  122 . The crimping cam  120  may have a decreasing inner radius that applies a compressive force to the collet  122  as the collet  122  moves proximally within the crimping cam  120 . While  FIG. 7  depicts an embodiment of a crimping cam  120  having tapers  150 , the depicted profile should be understood to be a non-limiting example of a crimping cam design. 
     The collet  122  may be retained within the crimping cam  120  by the threaded rod  118 . When threaded through the complimentary threads on the crimping cam  120 , the threaded rod  118  may apply a longitudinal compressive force on the collet  122 . The crimping cam  120 , collet  122 , actuator knob  112 , and threaded rod  118  form the rotating assembly  132  and define the rotational component within the actuator slider  136  and the controller body  116 . 
       FIG. 8  depicts the assembly of the controller body  116 , actuator slider  136 , threaded insert  138 , and one-way bearing  134 . In an embodiment, the assembly process may include attaching the one-way bearing  134  to the interior of the threaded insert  138 . The one-way bearing  134  may include indicia (not shown) that indicate the rotating direction and locking direction. In some embodiments, the threaded insert  138  may include a slight taper on the interior diameter  158  such that the one-way bearing  134  may be inserted into the threaded insert from the proximal end of the threaded insert  160  (the end opposing the flange  154 ) such that the one-way bearing  134  can only be inserted into the threaded insert  138  before the threaded insert  138  is inserted into the actuator slider  136 . The threaded insert  138  may include left-hand threads  140  and a flange  154  that complimentarily mate with the complimentary threads  142  and a notch  156  on the actuator slider  136 . The threaded insert  138  may, therefore, fit in the actuator slider  136  in one direction. The threaded insert  138  may then be driven into the actuator slider  136  along the left-hand threads  140  and complimentary threads  142  by applying torque to the one-way bearing  134  and rotating the one-way bearing  134  in the locking direction. 
     If the one-way bearing  134  is oriented correctly in the threaded insert  138 , and the threaded insert  138  is aligned correctly with the actuator slider  136 , the threaded insert  138  will drive into the actuator slider  136  and affix the one-way bearing  134  to the actuator slider  136  in the desired orientation. If the one-way bearing  134  is oriented incorrectly in the threaded insert  138 , the application of torque to the one-way bearing  134  will result in the one-way bearing  134  rotating in the rotating direction and fail to transfer any torque to drive the threaded insert  138  into the actuator slider  136 . The actuator slider  136  may have a bore  152  extending therethrough, into which the rotating assembly  132  may fit. 
       FIG. 9  shows a schematic representation of the rotating assembly  132  being inserted into the one-way bearing  134  that has been affixed to the actuator slider  136  according to the method described in relation to  FIG. 8 . The rotating assembly  132  may be connected to the interior of the one-way bearing  134  using a friction fit, a press fit, an adhesive, a weld, other suitable attachment mechanism, or combinations thereof, as described in relation to  FIG. 3 . The rotating assembly  132  may be contained within a bore  152  that extends through the actuator slider  136 . The rotating assembly  132  may contact the wall of the bore  152 . In an embodiment, the controller  102  may include a layer of boundary material  162  between the rotating assembly  132  and the wall of the bore  152 . 
     In some embodiments, the boundary material  162  may be made of or include a low-friction and/or lubricious material. For example, the the boundary material  162  may be made of or include polyoxymethylene, polytetraflouroethylene, or similar materials. In other embodiments, the boundary material  162  may be a low-wear, high durability coating. In some embodiments, the boundary material  162  may include a coating on the rotating assembly  132 , a coating on the wall of the bore  152 , integral to the rotating assembly  132 , integral to the wall of the bore  152 , or combinations thereof. Additionally, the boundary material  162  may be a discrete component providing a substantially circumferential boundary around the rotating assembly  132 . In an embodiment, the boundary material  162  may be a continuous layer. For example, the boundary material  162  may cover the entirety of the surface, longitudinally and/or circumferentially around the rotating assembly  132 . In another embodiment, the boundary material  162  may include a non-continuous and/or intermittent distribution that provides a set space between the rotating assembly  132  and the wall of the bore  152 . For example, the boundary material  162  may include a plurality of circumferential strips that are spaced along the longitudinal length of the rotating assembly  132 . In another example, the boundary material  162  may include a plurality of longitudinal strips that are spaced along the circumference of the rotating assembly  132 . 
     The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of a stated amount. 
     In the description herein, various relational terms are provided to facilitate an understanding of various aspects of some embodiments of the present disclosure. Relational terms such as “bottom,” “below,” “top,” “above,” “back,” “front,” “left,” “right,” “rear,” “forward,” “up,” “down,” “horizontal,” “vertical,” “clockwise,” “counterclockwise,” “upper,” “lower,” and the like, may be used to describe various components, including their operation and/or illustrated position relative to one or more other components. For example, “proximal” and “distal” may indicate position and direction relative to the operator during use of the intravascular delivery system. Relational terms do not indicate a particular orientation for each embodiment within the scope of the description or claims. Accordingly, relational descriptions are intended solely for convenience in facilitating reference to various components, but such relational aspects may be reversed, flipped, rotated, moved in space, placed in a diagonal orientation or position, placed horizontally or vertically, or similarly modified unless otherwise specified. Certain descriptions or designations of components as “first,” “second,” “third,” and the like may also be used to differentiate between identical components or between components which are similar in use, structure, or operation. Such language is not intended to limit a component to a singular designation. As such, a component referenced in the specification as the “first” component may be the same or different than a component that is referenced in the claims as a “first” component. 
     Furthermore, while the description or claims may refer to “an additional” or “other” element, feature, aspect, component, or the like, it does not preclude there being a single element, or more than one, of the additional element. Where the claims or description refer to “a” or “an” element, such reference is not be construed that there is just one of that element, but is instead to be inclusive of other components and understood as “at least one” of the element. It is to be understood that where the specification states that a component, feature, structure, function, or characteristic “may,” “might,” “can,” or “could” be included, that particular component, feature, structure, or characteristic is provided in some embodiments, but is optional for other embodiments of the present disclosure. The terms “couple,” “coupled,” “connect,” “connection,” “connected,” “in connection with,” and “connecting” refer to “in direct connection with,” or “in connection with via one or more intermediate elements or members.” Components that are “integral” or “integrally” formed include components made from the same piece of material, or sets of materials, such as by being commonly molded or cast from the same material, or commonly machined from the same piece of material stock. Components that are “integral” should also be understood to be “coupled” together. 
     Although various example embodiments have been described in detail herein, those skilled in the art will readily appreciate in view of the present disclosure that many modifications are possible in the example embodiments without materially departing from the present disclosure. Accordingly, any such modifications are intended to be included in the scope of this disclosure. Likewise, while the disclosure herein contains many specifics, these specifics should not be construed as limiting the scope of the disclosure or of any of the appended claims, but merely as providing information pertinent to one or more specific embodiments that may fall within the scope of the disclosure and the appended claims. Any described features or elements from the various embodiments disclosed may be employed in combination with any other features or elements disclosed herein. 
     A person having ordinary skill in the art should realize in view of the present disclosure that equivalent constructions do not depart from the spirit and scope of the present disclosure, and that various changes, substitutions, and alterations may be made to embodiments disclosed herein without departing from the spirit and scope of the present disclosure. Equivalent constructions, including functional “means-plus-function” clauses are intended to cover the structures described herein as performing the recited function, including both structural equivalents that operate in the same manner, and equivalent structures that provide the same function. It is the express intention of the applicant not to invoke means-plus-function or other functional claiming for any claim except for those in which the words ‘means for’ appear together with an associated function. Each addition, deletion, and modification to the embodiments that falls within the meaning and scope of the claims is to be embraced by the claims.