Abstract:
A blanket assembly for swaddling an infant (e.g., newborn baby) includes a blanket body defining a pocket between an upper layer and a lower layer of the body at one end of the blanket body, the pocket accessible via an opening selectively closeable to seal the pocket. A neck, spine and spinal cord support device of a semi-rigid material is removably insertable in the pocket of the blanket body and secured within the blanket by the pocket so as to maintain the support device in a substantially fixed position within the blanket body. The support device supports the head, neck, spine and spinal cord of a newborn baby or infant when the infant is laid on the blanket body in a supine position and wrapped in the blanket body, so as to inhibit injury to the infant&#39;s head, neck, spine and spinal cord while carried by a person.

Description:
BACKGROUND 
     1. Field 
     The present invention is directed to a neck, spine and spinal cord support device for a new born baby or infant, and more particularly to a blanket assembly incorporating the support device. 
     2. Description of the Related Art 
     The body parts most susceptible to injury in an infant&#39;s body are the head, neck, spine and spinal cord, particularly in newborn babies and infants up to 6 months old. To this day there is a possibility that challenges, from learning disabilities to Autism, may be caused from injury to the spinal cord at these early stages in an infant&#39;s life. Babies rely on their care takers (e.g., parents) to hold and support their head, spine, neck and spinal cord without jarring them, all the while comforting them, swaddling them, and/or rocking them in their arms, as well as feeding them. A slight jar or jolt can possibly cause short term or long term (e.g., permanent) damage to the spinal cord, causing challenges later on in life for the child, such as learning disabilities and Autism. 
     New parents and others can struggle to properly hold newborn babies in a way that adequately supports the baby&#39;s head, neck, spine and spinal cord, especially when the person has not previously held newborn babies. Proper support to the head, neck, spine and spinal cord of the newborn baby is important and lack of such proper support can result in discomfort and even injury to the baby (e.g., injury to the head or spinal cord of the baby), as discussed above. 
     Often, people will hold the baby by holding the baby in one arm so that the baby&#39;s back (spine and spinal cord) is supported by the forearm and the baby&#39;s head and neck is supported between the person&#39;s forearm and upper arm. However, this method often does not allow the person the freedom to easily take care of other tasks with their free arm because they either use two arms to hold the baby or are nervous about maintaining proper support for the baby so that they instead opt to put the baby down (e.g., in a crib) before proceeding to handle other tasks. 
     Accordingly, there is a need for an improved system for ensuring proper support for the baby&#39;s head, neck, spine and spinal cord while being held by a person, and for allowing the person to readily perform other tasks with their free arm while securely holding the baby with their other arm. 
     SUMMARY 
     In accordance with one embodiment, a blanket assembly for swaddling an infant is provided. The blanket assembly comprises a blanket body defining a pocket between an upper layer and a lower layer of the body at one end of the blanket body, the pocket accessible via an opening selectively closeable to seal the pocket. The blanket assembly also comprises a neck, spine and spinal cord support device of a semi-rigid material, the support device removably insertable in the pocket of the blanket body and secured within the blanket by the pocket so as to maintain the support device in a substantially fixed position within the blanket body. The support device is configured to support the head, neck, spine and spinal cord of an infant when the infant is laid on the blanket body in a supine position and wrapped in the blanket body, and so as to inhibit injury to the infant&#39;s head and back while carried by a person. 
     In accordance with another embodiment, a blanket assembly for swaddling an infant is provided. The blanket assembly comprises a blanket body defining a pocket between an upper layer and a lower layer of the body at one end of the blanket body, the pocket accessible via an opening selectively closeable to seal the pocket. The blanket assembly also comprises a monolithic neck, spine and spinal cord support device of a semi-rigid material and comprising a generally planar distal portion and a concave section at a proximal portion thereof, the support device removably insertable in the pocket of the blanket body and secured within the blanket by the pocket so as to maintain the support device in a substantially fixed position within the blanket body. The support device is configured to support the head, neck, spine and spinal cord of an infant when the infant is laid on the blanket body in a supine position and wrapped in the blanket body, the infant&#39;s head being supported by the concave portion and the infant&#39;s torso being supported by the distal portion, so as to inhibit injury to the infant&#39;s head and back while carried by a person. 
     In accordance with another embodiment, a neck, spine and spinal cord support device for supporting an infant is provided. The support device comprises a monolithic body of a semi-rigid material, comprising a generally planar distal portion and a proximal portion having a concave section. The body is configured to support a head, neck, spine and spinal cord of an infant when the infant is laid in supine position on the body, the concave section configured to at least partially receive the infant&#39;s head, the distal portion configured to support the infant&#39;s back. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic top perspective view of one embodiment of a neck, spine and spinal cord support device for use with a corresponding blanket for supporting a newborn baby or infant. 
         FIG. 2  is a schematic top planar view of the support device of  FIG. 1 . 
         FIG. 3  is a schematic side elevational view of the support device of  FIG. 1 . 
         FIG. 4  is a schematic front or rear elevational view of the support device of  FIG. 1 . 
         FIG. 5A  is a schematic exploded view of one embodiment of a blanket that holds the support device, and the support device of  FIG. 1 . 
         FIG. 5B  is a schematic end view of the blanket of  FIG. 5A  showing an opening that receives the support device therein. 
         FIG. 6  is a schematic top planar view of the blanket and support device of  FIG. 5  in an assembled form. 
         FIG. 7  is a schematic bottom planar view of one embodiment of a blanket for use with the support device of  FIG. 1 . 
         FIG. 8  is a schematic top view of the blanket assembly of  FIG. 6  wrapped around a baby. 
         FIG. 9  is a schematic partial side view of the blanket assembly wrapped around the baby of  FIG. 8 . 
         FIG. 10  is a schematic perspective partial view of a user supporting blanket assembly wrapped around a baby, as shown in  FIG. 8 , with one hand under the support device. 
         FIG. 11A  is a schematic perspective partial view of a portion of one embodiment of the assembled blanket assembly wrapped around the baby of  FIG. 8  with fasteners for attaching of a beanie or head cover to the blanket. 
         FIG. 11B  is a schematic perspective partial view of the assembled blanket assembly of  FIG. 11A  with the beanie attached to the blanket. 
         FIG. 12  is a schematic top planar view of another embodiment of a neck, spine and spinal cord support device for supporting a newborn baby or infant. 
         FIG. 12A  is a schematic block diagram of one embodiment of a heating system for the support device of  FIG. 12 . 
         FIG. 13  is a schematic top planar view of another embodiment of a neck, spine and spinal cord support device for supporting a newborn baby or infant. 
         FIG. 13A  is a schematic block diagram of one embodiment of a sound or vibration system for the support device of  FIG. 13 . 
         FIG. 14  is a schematic top planar view of one embodiment of a sleeve having a heating and/or sound/vibration system that receives the support device of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
       FIGS. 1-4  show one embodiment of a neck, spine and spinal cord support device  100  that can be used to support the head, neck, spine and spinal cord of an infant, such as a newborn baby. The support device  100  advantageously provides consistent alignment of the head, neck, spine and spinal cord for the baby and can be used until the baby&#39;s neck and back muscles sufficiently strengthen (e.g., when the baby is able to support their head without assistance). The support device  100  can have a body  10  that extends from a proximal edge  12  to a distal edge  14  and between a medial edge  16   a  and a lateral edge  16   b . In the illustrated embodiment, the proximal edge can be curved (e.g., extend along a curve between the medial and lateral edges  16   a ,  16   b ) and the distal edge  14  and be generally straight. However in other embodiments, the proximal edge  12  can be generally straight. In still another embodiment, the distal edge  14  can be curved between the medial and lateral edges  16   a ,  16   b . In one embodiment, the medial and lateral edges  16   a ,  16   b  can be generally parallel along at least a portion of their length. 
     In one embodiment, the body  10  can have a distal portion  18  and a proximal portion  20 . In one embodiment, the distal portion  18  can be generally planar and have a width W (defined between the medial and lateral edges  16   a ,  16   b ) sized to wider than the torso of an infant (e.g., newborn baby). In one embodiment, the width W can be between about 5 inches and about 9 inches. In another embodiment, the width W can be about 7 inches. The body  10  can have a length L (defined between the proximal and distal edges  12 ,  14 ) sized to be longer than the torso of an infant (e.g., newborn baby) such that the infant&#39;s buttocks rest on the distal portion  18  proximal of the distal edge  14 . In one embodiment, the length L can be between about 12 inches and about 18 inches. In another embodiment, the length L can be about 15 inches. The body  10  can have a thickness t of between about 0.05 inches and about 1 inch. In another embodiment, the thickness t can be about 0.08 inches. In one embodiment, the distal portion  18  can be substantially flat. However, the body  10  can have other lengths L, widths W and thickness t values, higher or lower, than those discussed above. 
     With continued reference to  FIGS. 1-4 , the proximal portion  20  can have a concave section  22  with a generally circular outermost perimeter  24 . In one embodiment, the perimeter  24  can have a diameter D of between about 4 inches and about 6 inches. In another embodiment, the diameter D can be about 5 inches. The concave section  22  can have a radius of curvature r of between abut 1.5 inches and about 2.5 inches. In another embodiment, the radius of curvature r can be about 2 inches. In the illustrated embodiment, the concave section  22  is aligned generally along the axis X of the device  100 . Additionally, a boundary portion  26  extends between the outermost perimeter  24  of the concave section  22  and the proximal edge  12  and medial and lateral edges  16   a ,  16   b . In one embodiment, the boundary portion  26  can be between about 1 inch and about 2 inches in width. In one embodiment, the boundary portion  26  is wider between the proximal edge  12  and the concave section  22  than between the concave section  22  and the medial and lateral edges  16   a ,  16   b . In another embodiment, the boundary section  26  has the same width between the concave section  22  and the proximal, lateral and medial edges  12 ,  16   a ,  16   b . The concave section  22  can be shaped to at least partially receive the head of an infant (e.g., newborn baby) therein so as to comfortably cradle the infant&#39;s head therein. For example, the diameter D can be sized so as to be greater than an average distance between the sides of the infant&#39;s head so that the perimeter does not tightly fit on the infant&#39;s head. Additionally a depth d of the concave section  22  is preferably sized so that between about 5% and about 25% of the infant&#39;s head extends into the concave section  22 ; in another embodiment, the depth d of the concave section  22  can be sized so that less or more of the infant&#39;s head extends into the concave section  22  than noted above. In another embodiment, the depth d is preferably sized so that the boundary portion  26  is disposed below the infant&#39;s ears when the infant&#39;s head rests in the concave section  22 . In still another embodiment, the depth d is preferably sized so that when the infant lies on the support device  100 , the infant&#39;s spine is aligned from the buttocks to the head of the infant. In one embodiment, the depth d can be between about two inches and about three inches. However, the proximal portion  20  can have other suitable dimensions, including other suitable depths. 
     In one embodiment, the support device  100  can be made of a rigid or semi-rigid material. For example, in one embodiment the device  100  can be made of a plastic material (e.g., a thermoset or thermoplastic material), such as polyurethane, polyester, polystyrene, low-density or high-density polyethylene (PE), polypropylene (PP), and polyvinyl chloride (PVC), and polytetrafluoroethylene. However, other suitable materials can be used, such as hard plastic or resilient materials. In one embodiment, the device  100  can be molded (e.g., injection molded) or manufactured using a cast. However, other suitable methods can be used to manufacture the device  100 . The device  100  can preferably support an infant weighing between about 4 lbs and about 18 lbs, and being between about 16 inches and about 26 inches in length. In the illustrated embodiment, the infant can be supported by the device  100  so that the infant&#39;s head rests on the concave section and the infant&#39;s back (e.g., including the buttocks) rests on the distal portion  18  so that the infants head and spine are supported when the infant lies (e.g., is in a supine position) on the device  100 . The device  100  advantageously provides appropriate support to the infant&#39;s head, neck, spine and spinal cord while the infant is held or carried in a person&#39;s arm (e.g., carried by a person that is experience, inexperienced or unfamiliar with respect to holding infants correctly). 
       FIGS. 5A-10  show one embodiment of a baby blanket assembly  200  that includes a blanket  220  (e.g., a swaddle blanket) and can incorporate the support device  100  therein. The blanket  220  can be made of a fabric, such as cotton. However, the blanket  220  can be made of other suitable blanket materials, such as wool, fleece, etc. The blanket  220  can have a body  224  with a top surface  224   a  and a bottom surface  224   b . In the illustrated embodiment, the blanket  220  has a generally square shape when in an unfolded orientation, with a proximal portion  226  having a curved shape that generally corresponds to the curved proximal edge  12  of the support device  100 . In other embodiments, the blanket  220  can have other suitable shapes, such as rectangular, circular, triangular and oval. In still other embodiments, the proximal portion  226  can have other suitable shapes that correspond to a shape of the proximal edge of the device  100 . 
     The proximal portion  226  can define a pocket  228  between an upper layer  226   a  and a lower layer  226   b  of the blanket  220  that can be accessed through an opening  230  at the edge of the proximal portion  226 . The pocket  228  is preferably sized and shaped to removably receive the support device  100  therein so that the device  100  is enclosed between the layers  226   a ,  226   b  of the blanket  220 . In one embodiment, the pocket  220  is sized and shaped so as to securely hold the device  100  in the pocket  228  so that the device  100  does not shift once incorporated into the blanket  220 . For example, in one embodiment, the pocket  28  has a length L′ and width W′ that is generally the same as the length L and width W of the device  100 . The opening  230  can be selectively closed with one or more fasteners  232  (see  FIG. 7 ). In one embodiment, the one or more fasteners  232  can be buttons. In another embodiment, the fasteners  232  can be snap fasteners. In still another embodiment, the one or more fasteners  232  can be a zipper. In still another embodiment, the one or more fasteners  232  can be a hoop-and-loop fastener, such as VELCRO®. 
     With reference to  FIG. 7 , the blanket  220  can have a strap or hand pocket  234  on the bottom surface  224   b  that defines an opening  236  into which or through which a user can at least partially insert a portion (e.g., fingers, palm) of their hand to provide an additional safety, stability and support for the infant once wrapped with the blanket, as discussed further below. In one embodiment, the strap  234  is located a distance Y from the edge of the proximal portion  226 . In one embodiment, the distance Y is between about 7 inches and about 15 inches. In another embodiment the distance Y is about 10 inches. Advantageously, the distance Y can be such that the user&#39;s hand would be disposed under the support device  100 , such as halfway along the length of the support device  100 . 
       FIGS. 8-10  show the blanket assembly  200  in use. As shown in  FIG. 8 , the infant (e.g., newborn baby) can be placed on the top surface  224   a  of the blanket  220  so that the infant&#39;s head rests on the proximal portion  226  proximate the location of the concave section  22  of the device  100  within the blanket  220 , and so that the infant&#39;s torso extends toward the center of the blanket  220  and rests over the distal portion  18  of the device  100 . The blanket  220  can then be wrapped over the infant (e.g., in a swaddling configuration) so as to generally restrict movement of the infant&#39;s arms and legs. Once wrapped, the infant can be held (e.g., even by a person unfamiliar or inexperienced with holding infants, such as newborn babies) in a manner that ensures the infant&#39;s head and spine will be properly supported while being carried. As shown in  FIG. 9 , the blanket  220  and concave section  22  of the support device  100  comfortably support the infant&#39;s head without putting pressure on the sides of the infant&#39;s head while allowing the curved surface of the concave section  22  to comfortably accommodate the natural curvature of the infant&#39;s head.  FIG. 10  shows the infant wrapped in the blanket assembly  200  and being held (e.g., supported) with one hand via the strap  234  on the back surface  22   b  of the blanket  220  (e.g., with the user&#39;s hand inserted into or through the strap  234  or pocket). Advantageously, the strap  234  allows the person holding the infant with increased flexibility in performing a variety of other tasks with their free hand while securely holding the infant with their other hand. 
       FIGS. 11A-11B  show another embodiment of a blanket assembly  200 ′. The blanket assembly  200 ′ is identical to the blanket assembly  200  shown in  FIGS. 5A-10 , except as noted below. Thus, the reference numerals used to designate the various components of the blanket assembly  200 ′ are identical to those used for identifying the corresponding components of the blanket assembly  200  in  FIGS. 5A-10 , except that a “′” has been added to the reference numerals. 
     The blanket assembly  200 ′ can have one or more fasteners  240 ′ disposed on the top surface  224   a ′ of the proximal portion  226 ′ of the blanket body  224 ′. In the illustrated embodiment, the one or more fasteners  240 ′ are arranged along the perimeter of the proximal portion  226 ′. In one embodiment, the fasteners  240 ′ can be can be buttons. In another embodiment, the fasteners  240 ′ can be snap fasteners. In still another embodiment, the one or more fasteners  240 ′ can be a zipper. In still another embodiment, the one or more fasteners  240 ′ can be a hoop-and-loop fastener, such as VELCRO®. The one or more fasteners  240 ′ can be used to removably fasten a head cover portion  250 ′ to the proximal portion  226 ′ of the blanket body  224 ′. The head cover portion  250 ′ can then fit over the forehead of the infant to keep the infant&#39;s head warm. Advantageously, the head over portion  250 ′ can inhibit the infant&#39;s head from moving forward (e.g., when the infant is held in an elevated position closer to vertical), thereby ensuring the infant&#39;s head and neck are properly supported even when the baby is held in a generally upright position. In one embodiment, the head cover portion  250 ′ can be a beanie. In another embodiment, the head cover portion  250 ′ can be shaped like a cap or have a visor portion. In one embodiment the head cover portion  250 ′ can be made of fabric, such as cotton or wool. However, the head cover portion  250 ′ can be made of other suitable materials. In one embodiment, the head cover portion  250 ′ is made of the same material as the blanket  220 . In another embodiment, the head cover portion  250 ′ is made of a different material than the blanket  220 . 
       FIGS. 12-12A  show another embodiment of a neck, spine and spinal cord support device  100 A for supporting a newborn baby or infant. The support device  100 A is similar to the support device  100  shown in  FIG. 1 , except as noted below. Thus, the reference numerals used to designate the various components of the support device  100 A are identical to those used for identifying the corresponding components of the support device  100  in  FIG. 1 , except as described below. 
     In the illustrated embodiment, the support device  100 A can include (e.g., incorporate) a heating system  300  having one or more heating elements  310  (e.g., resistive heating elements). In one embodiment, the one or more heating elements  310  can be incorporated within the body  10  (e.g., embedded in the body  10 ). In another embodiment, the one or more heating elements  310  can be provided on an outer surface of the body  10 . In still another embodiment, the heating system  300  can be in a separate component (e.g., blanket sleeve) from the body  10 , as described further below. In the illustrated embodiment, the one or more heating elements  310  are provided on the distal portion  18  of the body  10 . In another embodiment, at least one of the one or more heating elements  310  can be provided in the proximal portion  20  of the body. 
     In one embodiment, the heating system  300  is at least partially incorporated into the body  10 . In another embodiment, one or more components of the heating system  300  can be provided separate from the body  10  (e.g., in a component separate from the body  10 ). 
     The heating system  300  can include a switch  302  that can be actuated by a user to turn the heating system  300  ON and OFF. In one embodiment, the switch  302  can be provided on a surface (e.g., a bottom surface) of the body  10 . The switch  302  can communicate with a controller  304  (e.g., electronic controller) that controls operation of the one or more heating elements  310 . The heating system  300  can have one or more batteries  306  (e.g., low voltage batteries), that can provide power to the controller  304  and heating elements  310 . In one embodiment, the heating system  310  can include a temperature sensor (e.g. at the one or more heating elements  310  or on a surface of the body  10 ) that communicates sensed temperature information to the controller  304 . 
     In one embodiment, the controller  304  operates the one or more heating elements  310  a predetermined temperature setpoint. In another embodiment, the switch  302  can be operated by the user to select one of a plurality of temperature settings (e.g., low, medium, high), and the controller  304  can control the operation of the one or more heating elements  310  (e.g., control the amount of power provided by the one or more batteries  306  to the one or more heating elements  310 ) based upon the user selected temperature setpoint provided by the switch  302 . In one embodiment, the controller  304  can include (or can be) a temperature limiting switch that can shut power to the one or more heating elements  310  if a temperature limit of the switch is exceeded. The temperature limiting switch can normally be closed during operation of the heating system  300 , and can open if the temperature limit for the switch is exceeded. Advantageously, the heating system  300  can be selectively operated by a user to provide additional warmth for the baby and help keep the baby warm and comfortable in cold weather. 
       FIGS. 13-13A  show another embodiment of a neck, spine and spinal cord support device  100 B for supporting a newborn baby or infant. The support device  100 B is similar to the support device  100  shown in  FIG. 1 , except as noted below. Thus, the reference numerals used to designate the various components of the support device  100 B are identical to those used for identifying the corresponding components of the support device  100  in  FIG. 1 , except as described below. 
     In the illustrated embodiment, the support device  100 B can include (e.g., incorporate) a sound or vibration system  400  having one or more vibration elements  410  (e.g., speakers, such as piezo speakers). In one embodiment, the one or more vibration elements  410  can be incorporated within the body  10  (e.g., embedded in the body  10 ). In another embodiment, the one or more vibration elements  410  can be provided on an outer surface of the body  10 . In still another embodiment, the sound or vibration system  400  can be in a separate component (e.g., blanket sleeve) from the body  10 , as described further below. In the illustrated embodiment, the one or more vibration elements  410  are provided on the distal portion  18  of the body  10 . In another embodiment, at least one of the one or more vibration elements  410  can be provided in the proximal portion  20  of the body. 
     In one embodiment, the sound or vibration system  400  is at least partially incorporated into the body  10 . In another embodiment, one or more components of the sound or vibration system  400  can be provided separate from the body  10  (e.g., in a component separate from the body  10 ). 
     The sound or vibration system  400  can include a switch  402  that can be actuated by a user to turn the sound or vibration system  400  ON and OFF. In one embodiment, the switch  402  can be provided on a surface (e.g., a bottom surface) of the body  10 . The switch  402  can communicate with a controller  404  (e.g., electronic controller) that controls operation of the one or more vibration elements  410 . The sound or vibration system  400  can have one or more batteries  406  (e.g., low voltage batteries), that can provide power to the controller  404  and vibration elements  410 . The sound or vibration system  400  can also include a memory  408  that can store one or more sounds (e.g., heart beat, breathing sound), and which can communicate such one or more sounds with the one or more vibration elements  410  via the controller  404 . In one embodiment, the sound or vibration system  400  can allow the user to record user selected sounds (e.g., Mother&#39;s heartbeat, breathing, and/or voice) to the memory  408 . 
     In one embodiment, the controller  404  operates the one or more vibration elements  410  to provide a predetermined sound or vibration. In another embodiment, the switch  402  can be operated by the user to select one of a plurality of sound settings (e.g., heart beat, breathing, ocean waves), and the controller  404  can control the operation of the one or more vibration elements  310  (e.g., control the amount of power provided by the one or more batteries  406  to the one or more vibration elements  410 , or the sound broadcast by the vibration elements  410  via the memory  408 ) based upon the user selected sound setting provided by the switch  402 . In one embodiment, the controller  404  can include a sound limiting switch that can shut power to the one or more vibration elements  410  if the sound level exceeds a predetermined decibel level. The sound limiting switch can normally be closed during operation of the sound or vibration system  400 , and can open if the decibel limit for the switch is exceeded. Advantageously, the sound or vibration system  400  can be selectively operated by a user to provide sounds and/or vibrations to comfort and soothe the baby while being supported on the support device  100 B. 
       FIG. 14  shows another embodiment, where the heating system  300  and/or sound/vibration system  400  can be provided in a separate sleeve  500 , which can be slipped over the support device  100  to provide a support system that provides heating and/or sound/vibration to the baby while supported on the support device  100 . Where the heating system  300  and sound/vibration system  400  are combined, a single switch can operate as the switches  302 ,  402 , a single controller can operate as the controllers  304 ,  404 , and a single battery pack can provide the one or more batteries  306 ,  406 . 
     In one embodiment, the sleeve  500  can be like a heated blanket that can be used to cover the support device  100  so as to provide the heating system  300 , as well as cushioning. In one embodiment, once the sleeve  500  is slipped over the support device  100 , the combined structure can be inserted into the pocket  228  of the blanket assembly  200 . In another embodiment, the blanket assembly  200  can incorporate the heating system  300  or sound/vibration system  400  into the blanket  220 . 
     Of course, the foregoing description is of certain features, aspects and advantages of the present invention, to which various changes and modifications can be made without departing from the spirit and scope of the present invention. Thus, for example, those skill in the art will recognize that the invention can be embodied or carried out in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. In addition, while a number of variations of the invention have been shown and described in detail, other modifications and methods of use, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is contemplated that various combinations or sub-combinations of the specific features and aspects between and among the different embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the discussed devices, systems and methods (e.g., by excluding features or steps from certain embodiments, or adding features or steps from one embodiment of a system or method to another embodiment of a system or method).