Patent ID: 12257406

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to embodiments of the present invention, which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein exemplify, but do not limit, the present invention by referring to the drawings.

It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

Referring in more specific detail toFIG.1of the drawings, there is illustrated a medical device such as a safety IV catheter assembly100incorporating a catheter hub (hub)102and a flexible tube or cannula103. The catheter hub102is releasably engaged to a needle tip shield118(housing). The catheter tube103is directly or indirectly connected to the hub102or housing118. The material of the catheter tube103may consist of, for example, polyurethane (PU), FEP or PTFE (Teflon™). For purposes of illustration, the catheter hub102is shown attached to an introducer needle hub120prior to insertion. The catheter hub102includes a push tab112and anti-rotation features in the form of extension members114and116. A user can engage the push tab112to advance the catheter hub102forward thereby advancing the catheter. As illustrated inFIG.1, the push tab112extends radially from an upper surface of the catheter hub102. The first extension114extends from a first side of the push tab112around the side of the upper surface of the catheter hub102and the second extension116extends from a second side of the push tab112around the other side of the upper surface of the catheter hub102. The first extension114and the second extension116act as anti-rotation members that counteract rotation of the catheter hub102. The push tab and first and second extensions together form a substantially C-shape when viewed from above.

The push tab and first and second extensions are shaped and configured to cradle a user's finger as the push tab112is advanced forward. The first extension114and second extension116resist angular rotation of the catheter hub102relative to the user's finger and enhance stability during insertion.

In an alternate embodiment (not shown), the push tab112and extension members114,116are similarly disposed on a top distal surface of the needle tip shield118, instead of on the catheter hub102. The introducer needle hub120includes an opening at a top distal surface to allow the push tab112and extension members114,116of the needle tip shield118to extend upwardly and be accessible to the user. The catheter tube103is directly or indirectly connected to the hub102or housing118. Accordingly, the user can engage the push tab112on the needle tip shield118to advance the catheter hub102and catheter forward. After the catheter is inserted, the introducer needle hub120is used to withdrawn the introducer needle of the catheter assembly100from the catheter tube103and the catheter hub102. Subsequently, a distal end of the introducer needle is retracted and enclosed in the needle tip shield118. The push tab112and extension members114,116of the needle tip shield118also aid the user to withdraw the introducer needle of the catheter assembly100.

For this and other subsequently-described embodiments, all reference characters designating corresponding parts of the embodiments will be the same as in the embodiment ofFIG.1, except that they will be in a different series, for example, in the200series, or the300series. The differences of the second and third embodiments with respect to the first embodiment will now be described.

FIG.2depicts a push tab212formed on an upper surface of a catheter hub202for a catheter hub200. As illustrated inFIG.2, the push tab212is a wall-like formation extending radially from an upper surface of the catheter hub202. The push tab212includes a raised and sculpted configuration where a distal side of the wall-like main portion212is concave so as to conform to the curvature of the user's finger and allow the user to control rotation. A first extension214extends from a first side of the wall-like main portion212around an outer surface of the catheter hub202, and a second extension216extends from a second side of the main portion212around the outer surface of the catheter hub202. The first extension214and the second extension216act as anti-rotation members that counteract rotation of the catheter hub202. The sculpted configuration of the push tab212provides a tactile feel for the user with regard to placement of the user's finger.

FIG.3provides a sculpted push tab312on an upper surface of a catheter hub302. The push tab312includes ribs318disposed on a wall-like main portion of the tab312. Ribs318enhance the tactile feel with regard to placement of the user's finger and assist in maintaining the user's finger on the tab310.

A push tab412is formed on an upper surface of the catheter hub402illustrated inFIG.4for use with a catheter. The push tab412includes a wall-like main portion extending radially from an upper surface of the catheter hub402. The push tab412also includes a first extension414and a second extension416. The first extension414and second extension416both extend radially from side surfaces of the catheter hub. Together with the main portion412, they provide a larger circumference for the finger-engaging surface than the embodiments ofFIGS.2and3. At least one rib418is formed on the push tab412to facilitate engagement with a user's finger and prevent rotation. The first and second extension414and416limit rotation of the catheter hub402such that as the catheter rotates either clockwise or counterclockwise, either the first extension414or the second extension416will contact the skin of the patient and prevent further rotation, while the push tab412is still in contact with the clinician's finger, allowing advancement.

FIG.5illustrates a catheter hub502with a more deeply sculpted push tab512formed on an upper surface of the catheter hub502. The deep-sculpted push tab512includes a wall-like main portion extending radially from an upper surface of the catheter hub502. A first extension514and a second extension516extend from the wall-like main portion of the push tab512. The first extension514and second extension516both extend proximally on the catheter hub502and curve toward the main portion of the push tab512to cradle a user's finger by engaging the sides of the clinician's fingers and allow the user to control lateral motion and rotation. The first extension514and the second extension516act as anti-rotation members that counteract rotation of the catheter hub502.

RegardingFIG.6, a catheter hub602incorporating a catheter620is illustrated. A push tab612is formed on an upper surface of the catheter hub602. As illustrated inFIG.6, the push tab612is configured as a wall-like main portion extending radially from an upper surface of the catheter hub602. A first cradling tab614extends from a first side of the push tab612perpendicular to a plane of the push tab612. A second cradling tab616extends from a second side of the main portion612perpendicular to a plane of the push tab612. The push tab612, first extension614and second extension616thereby form a cradle shape to resist catheter hub rotation where the first extension214and the second extension216act as anti-rotation members that counteract rotation of the catheter hub202.

FIG.7illustrates a wing catheter hub702incorporating a flexible IV catheter720and wings730. An push tab712is formed on an upper surface of the catheter hub702. As illustrated inFIG.7, the push tab712includes a tall wall-like main portion extending radially from an upper surface of the catheter hub702. Anti-rotation push tab712provides a cradling effect for the user's finger to aid insertion stability.

A first rib714parallel to the plane of the push tab712, but shorter in height, extends from an upper surface of the catheter hub702and is spaced proximally from to the push tab712. A second rib716and a third rib718, also shorter in height than the first rib714, may also extend from an upper surface of the catheter hub702parallel to the plane of the push tab712. The ribs714,716, and718form a cradle shape to resist catheter hub rotation. Ribs714,716and718also strengthen the catheter hub to prevent shrinkage which could cause leakage for any internal components of the catheter hub requiring a lengthwise seal.

FIG.7illustrates three ribs714,716and718; however, a single rib814may be utilized to provide the necessary anti-rotational effect as illustrated inFIGS.8A and8B. The rib(s)714,716,718and814should be a distance from the push tab712/812where the rib is far enough from the push tab712/812to contact a user's advancing finger pad to provide stability but not so close that the finger pad does not contact the rib. The catheter hub802may be manufactured with or without wings830as shown inFIGS.8B and8A, respectively.

Referring now toFIGS.9A-9H, a catheter system900may include a catheter assembly902. In some embodiments, the catheter assembly902may include a catheter hub904, which may include a distal end906, a proximal end908, a lumen910disposed between the distal end906and the proximal end908. In some embodiments, a catheter tube909may extend distally from the distal end906of the catheter hub904. In some embodiments, the catheter tube909may include an 18 to 24 gauge catheter tube or another suitable catheter tube. In some embodiments, the catheter tube909may be secured within the catheter hub904by a wedge or another suitable means. In some embodiments, the catheter system900may include a cap911, which may be removed prior to insertion of the catheter system900into vasculature of a patient.

In some embodiments, the catheter hub904may include a push tab912, which may extend outwardly from an upper surface914of the catheter hub904. It should be understood that the embodiments ofFIGS.1-12may be combined. For example, in some embodiments, the push tab912ofFIGS.9-12may be similar or identical in terms of one or more included components and/or operation to one or more of the following: the push tab112, the push tab212, the push tab312, the push tab412, the push tab512, the push tab612, the push tab712, and the push tab812described with respect toFIGS.1-8. As another example, in some embodiments, the catheter hub904may include wings, illustrated, for example, inFIG.8B. In some embodiments, the catheter hub904may not include wings.

In some embodiments, the catheter hub904may include one or more ribs916, which may extend outwardly from the upper surface914of the catheter hub904. In some embodiments, as illustrated, for example, inFIGS.9A-9H, the catheter hub904may include a first rib916a, a second rib916b, and a third rib916c(which may be referred to collectively in the present disclosure as “ribs916”). In some embodiments, the catheter hub904may include more than three ribs916. In some embodiments, the ribs916may be proximal to the push tab912. In some embodiments, the second rib916bmay be proximal to the first rib916aand/or the third rib916cmay be proximal to the second rib916b. In some embodiments, the ribs916may be shorter in height than the push tab912. In some embodiments, the ribs916may be a same height as each other. In some embodiments, the ribs916may be generally parallel to each other. In some embodiments, the ribs916may be generally perpendicular to a longitudinal axis918of the catheter tube909. In some embodiments, the ribs916and the push tab912may be evenly spaced apart.

In some embodiments, the ribs916may form a cradle shape. In further detail, in some embodiments, a middle portion of each of the ribs916may be concave so as to conform to a curvature of the finger of the user. In some embodiments, the middle portion of each of the ribs916may be aligned with the longitudinal axis918of the catheter tube909. In some embodiments, a configuration of the first rib916a, the second rib916b, and the third rib916cmay enhance stability during insertion of the catheter system900into the vasculature of the patient and may resist angular rotation of the catheter hub904. In some embodiments, the first rib916a, the second rib916b, and the third rib916cmay cradle the finger of the user as the push tab912is advanced distally.

In some embodiments, the catheter system900may include a needle hub920and an introducer needle922extending distally from the needle hub920. In some embodiments, the introducer needle922may include a sharp distal tip924and a proximal end926. In some embodiments, the proximal end926may be secured within the needle hub920. In some embodiments, a distal end928of the introducer needle922may include a flashback notch930, which may extend through a wall of the introducer needle922proximate a lumen932within the introducer needle922. In some embodiments, the notch930may include an opening, which may be generally round or another shape. In some embodiments, the introducer needle922may extend through the catheter tube909when the catheter system900is in an insertion configuration ready for insertion into the patient.FIG.9Aillustrates the catheter system900in the insertion configuration, according to some embodiments.

In some embodiments, a septum934may be disposed within the lumen910of the catheter hub904. In some embodiments, the septum934may divide the lumen910of the catheter hub904into a distal chamber and a proximal chamber. In some embodiments, a septum actuator935may be configured to open the septum934in response to insertion of a medical device, such as an infusion device or a blood collection device, in the proximal end908of the catheter hub906. In some embodiments, the distal chamber may correspond to a flashback chamber929configured to receive blood in response to insertion of the introducer needle922into the vasculature of the patient.

In some embodiments, the septum934may be constructed of silicon or another suitable material. In some embodiments, the septum934may include a single use septum. For example, in response to the septum934being opened by the actuator935, the septum934may remain open. In some embodiments, the septum934may include a multi-use septum. In some embodiments, the actuator935may be coupled to a spring such that in response to the medical device being removed from the proximal end908of the catheter hub906, the septum934may return to a closed position.

In some embodiments, the push tab912and/or the ribs916may be constructed of a rigid or semi-rigid material. In some embodiments, the push tab912and/or the ribs916may be constructed of a same material as the catheter hub904. In these and other embodiments, the push tab912and/or the ribs916may be constructed of polypropylene, polyethylene, copolyester, polycarbonate, plastic, or another suitable material. In some embodiments, the push tab912, the ribs916, and the catheter hub904may be monolithically formed as a single unit. In some embodiments, the push tab912and/or the ribs916may be constructed of a soft or flexible material. For example, the push tab912and/or the ribs916may be constructed of a thermoplastic elastomer (TPE) or another suitable material.

In some embodiments, the catheter system900may be configured such that in response to insertion of the introducer needle922into the vasculature, blood flows proximally into the introducer needle922through the sharp distal tip924. In some embodiments, blood may then flow proximally through the flashback notch into a space between an outer surface of the introducer needle922and an inner surface of the catheter tube909. In some embodiments, blood may then flow proximally into the flashback chamber929, which may be disposed between a distal face936of the septum934and a proximal end938of the catheter tube909. In some embodiments, blood within the flashback chamber929may be visualized by the user and may indicate to the user that the introducer needle922is disposed within the vasculature. In some embodiments, the catheter hub904may be transparent or semitransparent, which may allow the user to visualize the blood within the flashback chamber929.

In some embodiments, the flashback chamber929may be disposed distal to the ribs916and the push tab912, which may improve visualization of the flashback chamber929by a user. In further detail, in some embodiments, the finger of the user may be stabilized on the push tab912and/or the ribs916during insertion of the catheter system900into the vasculature of the patient. In some embodiments, when the finger of the user is stabilized on the push tab912and/or the ribs916, the user's view of the flashback chamber929may not be impeded by the finger due to the flashback chamber929being disposed distal to the ribs916and the push tab912.

In some embodiments, the catheter system900may include a safety feature, which may shield the sharp distal tip924of the introducer needle922when the introducer needle922is withdrawn from the catheter hub904. In some embodiments, the safety feature may be passive, such that no activation is required by the user, as will be discussed further with respect toFIG.12. In some embodiments, the safety feature may include an active safety feature that is activated by the user.

In some embodiments, a safety feature940is an example of a possible active safety feature of the catheter system900. In some embodiments, the safety feature940may include a barrel942, a spring944, an activation latch946, and a projection948. In some embodiments, the barrel942may include a proximal end950and a distal end952. In some embodiments, the needle hub920may be slidably disposed in the barrel942. In some embodiments, the barrel942may be generally hollow. In some embodiments, the spring944may be disposed about the introducer needle922and the needle hub920.

In some embodiments, the activation latch946may include a top and a bottom and may be movably mounted adjacent to the distal end952of the barrel942. In some embodiments, the activation latch946may be adapted for selective engagement with the needle hub920to hold the needle hub920adjacent to the distal end952of the barrel942against the bias of the spring944such that the introducer needle922extends beyond the distal end952of the barrel942and through the catheter tube909with the catheter hub904adjacent to the distal end952of the barrel942. In some embodiments, the projection948may extend from the activation latch946for engagement with the catheter hub904to prevent movement of the activation latch946when the catheter hub904is adjacent to the distal end952of the barrel942.

In some embodiments, the activation latch946may extend into the barrel942via a slot954, which may be formed in barrel942adjacent to the distal end952. In some embodiments, the activation latch946may include an opening956, which may allow the introducer needle922and the needle hub920to extend through the activation latch946. In some embodiments, the activation latch946may include the projection948that extends toward the distal end906of the catheter hub904.

In some embodiments, when the activation latch946is “up” in a non-activated position, a smaller portion of the opening956is in communication with a lumen of the barrel942. In this position, a smaller portion of the opening956may engage the needle hub920and holds needle hub920adjacent to the distal end952of barrel942against the force of the spring944. In some embodiments, the needle hub920may include a generally hour-glass shape so that its medial portion has a smaller diameter than either end. This shape may facilitate engagement between the smaller portion of the opening956of the activation latch946and the needle hub920.

In some embodiments, when the activation latch946is in the non-activated position, the projection948may be located inside the catheter hub904. Thus, when the catheter tube909is still located on the introducer needle922with the catheter hub904adjacent to the distal end952of the barrel942, the projection948may prevent the activation latch946from being moved “down” into an activated position. In some embodiments, a length of the projection948may be long enough so the projection948engages the catheter hub904when the catheter hub904is adjacent to the distal end952of the barrel942. In some embodiments, the length of the projection948may not be so long that it interferes with use of the catheter tube909and the introducer needle922.

In some embodiments, when the catheter tube909is moved off the introducer needle922so the catheter hub904is not adjacent to the distal end952of the barrel942, the activation latch946can be moved “down,” i.e. activated, because the catheter hub904no longer interferes with the movement of the projection948. In this position, a larger portion of the opening956no longer engages the needle hub920. In some embodiments, the larger portion of the opening956may be larger than a maximum diameter of the needle hub920. In some embodiments, the spring944can thus force the needle hub920to the proximal end950of the barrel942and withdraw the sharp distal tip924of the introducer needle922into the barrel942.

In some embodiments, the ribs916may be configured to resist rotation of the catheter hub904with respect to the barrel942in response to distal advancement of the catheter hub904with respect to the barrel942and removal of the projection948from the distal end952of the barrel942.FIG.9Billustrates distal advancement of the catheter hub904with respect to the barrel942prior to activation of the activation latch946. In some embodiments, the user may distally advance the catheter hub904once the user observes blood within the flashback chamber929. In some embodiments, the finger of the user may be placed against the ribs916and/or the push tabs912to distally advance the catheter hub904and to resist rotation of the catheter hub904. In some embodiments, the catheter system900and/or the catheter hub904may be contacted by the user only at the push tab912and the ribs916. Thus, in some embodiments, the configuration of the push tab912and the ribs916is important for tactile response and rotational control.

In some embodiments, after the catheter hub904is distally advanced, the user may depress the activation latch946, which may retract the introducer needle922into the barrel942, where the introducer needle922may be fully encapsulated. In some embodiments, the activation latch946may be depressed by a particular finger of a first hand of the user while a particular finger of a second hand of the user is positioned on the ribs916and/or the push tab912to stabilize and prevent movement of the catheter hub903. In some embodiments, after the introducer needle922is withdrawn, the septum934may close to prevent blood from leaking from the proximal end908of the catheter hub904.

In some embodiments, the activation latch946may be disposed proximal to the flashback chamber929and/or the ribs916and the push tab912may be disposed between the activation latch946and the flashback chamber929. Thus, in some embodiments, a location of the ribs916, the push tab912, and the activation latch946with respect to the flashback chamber929may enable the user to place fingers of the user on one or more of the ribs916, the push tab912, and the activation latch946without obstructing the user's view of the flashback chamber929beneath the fingers.

Referring now toFIG.10, in some embodiments, the first rib916amay be shorter in height than the second rib916b. In some embodiments, the second rib916bmay be shorter in height than the third rib916c. In some embodiments, an upper surface of the first rib916a, an upper surface of the second rib916b, and an upper surface of the third rib916cmay be angled upwardly in a proximal direction, as illustrated, for example, inFIG.10A. In some embodiments, an angle of the upper surface of the third rib916cmay be greater than an angle of the upper surface of the second rib916b, which may be greater than an angle of the upper surface of the first rib916a. In these embodiments, the first rib916a, the second rib916b, and the third rib916cmay be configured to mirror a contour of the finger of the user.

Referring now toFIG.11, in some embodiments, the catheter hub904may include just one rib916, which may extend outwardly from the upper surface914of the catheter hub904. In some embodiments, the rib916may be proximal to the push tab912. In some embodiments, the rib916may be shorter in height than the push tab912. In some embodiments, the rib916may be generally perpendicular to the longitudinal axis918of the catheter tube909. In some embodiments, a distance between the rib916and the push tab912may be half or less than half of a distance between the push tab912and the distal end906of the catheter hub904, which may facilitate simultaneous contact between the push tab912and the rib916. In some embodiments, a space between the push tab912and the rib916may facilitate support of a substantial portion of the finger of the user, which may allow the user more control over the catheter hub904.

In some embodiments, the rib916may enhance stability during insertion of the catheter system900into vasculature of a patient and may resist angular rotation of the catheter hub904. In some embodiments, the rib916may cradle the finger of the user as the push tab912is advanced distally. In some embodiments, the flashback chamber929may be disposed distal to the rib916and the push tab912, which may improve visualization of the flashback chamber929by the user. Further, in some embodiments, the rib916may be configured to resist rotation of the catheter hub904with respect to the barrel942in response to distal advancement of the catheter hub904with respect to the barrel942and removal of the projection948from the distal end952of the barrel942.

Referring now toFIG.12, in some embodiments, the safety feature of the catheter system900may be passive. In some embodiments, a safety feature958is an example of a possible passive safety feature of the catheter system900. In some embodiments, the safety feature958may be configured to shield the sharp distal tip924of the introducer needle922in response to proximal withdrawal of the needle hub920with respect to the catheter hub904. A similar mechanism may occur in any number of suitable passive safety features that may be included in the catheter system900. In some embodiments, the ribs916may be configured to resist rotation of the catheter hub904with respect to the needle hub920in response to proximal withdrawal of the needle hub920with respect to the catheter hub904.

In some embodiments, the safety feature958may include a safety clip960, which may be positioned within a needle shield962to block and prevent the sharp distal tip924from exiting the needle shield962once the sharp distal tip924has been drawn proximally past the safety clip960. Thus, in some embodiments, the sharp distal tip924may be trapped within the needle shield962. In some embodiments, the needle hub920may be slidable proximally with respect to the needle shield962.

In some embodiments, the safety clip960may be configured to securely retain the connection between needle shield962and the proximal end908of the catheter hub904. In some embodiments, the safety clip960further comprises a pawl or other feature that selectively and/or temporarily interconnects with a surface of the proximal end908when the safety clip960is held in a first position. In some embodiments, the first position of the safety clip960may be maintained by contact between the introducer needle922and the safety clip960. In some embodiments, when the introducer needle922is withdrawn past the safety clip960in a proximal direction, the safety clip960may be released from the first position and may be repositioned to block the sharp distal tip924from exiting the needle shield962distally. In some embodiments, when the safety clip960is repositioned, the pawl or other feature releases the surface of proximal end908, thereby permitting physical separation of the catheter hub904from the needle shield962.

It is understood that the catheter system900may include any suitable active or passive safety mechanisms. In some embodiments, the safety feature may include an internal interlock in which the safety feature is coupled with an internal surface of the catheter hub904. Non-limiting examples of safety features that include an internal interlock are provided in: U.S. Pat. No. 8,496,623, titled BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM, filed Mar. 2, 2009; U.S. Pat. No. 9,399,120, titled BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM, filed Jul. 11, 2013; U.S. Patent Application No. 62/314,262, titled CANNULA CAPTURE MECHANISM, filed Mar. 28, 2016, each of which is herein incorporated by reference in its entirety.

In some embodiments, the safety feature may include an external interlock in which the safety feature is coupled with an external surface of the catheter hub904. Non-limiting examples of safety features that include an external interlock are provided in U.S. patent application Ser. No. 14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD AND INTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is herein incorporated by reference in its entirety.

In some embodiments, the safety feature may include a clip disposed within the catheter hub904, a non-limiting example of which is provided in U.S. Pat. No. 6,117,108, titled SPRING CLIP SAFETY IV CATHETER, filed Jun. 12, 1998, which is herein incorporated by reference in its entirety. In some embodiments, the safety mechanism may include a V-clip or a similar clip. A non-limiting example of a V-clip is provided in U.S. patent application Ser. No. 14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD AND INTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is herein incorporated by reference in its entirety. In some embodiments, the V-clip may selectively retain a portion of the catheter hub904.

The foregoing detailed description of the certain exemplary embodiments has been provided for the purpose of explaining the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. This description is not necessarily intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Any of the embodiments and/or elements disclosed herein may be combined with one another to form various additional embodiments not specifically disclosed, as long as they do not contradict each other. Accordingly, additional embodiments are possible and are intended to be encompassed within this specification and the scope of the invention. The specification describes specific examples to accomplish a more general goal that may be accomplished in another way.

As used in this application, the terms “front,” “rear,” “upper,” “lower,” “upwardly,” “downwardly,” and other orientational descriptors are intended to facilitate the description of the exemplary embodiments of the present invention, and are not intended to limit the structure of the exemplary embodiments of the present invention to any particular position or orientation. Terms of degree, such as “substantially” or “approximately” are understood by those of ordinary skill to refer to reasonable ranges outside of the given value, for example, general tolerances associated with manufacturing, assembly, and use of the described embodiments.