Abstract:
A soft arm support and protection device for use during a medical procedure when a patient is lying supine or prone. The device may be made from a soft neoprene material which is positioned under the patient&#39;s body. Enveloping leaves of material wrap from above and below the arm to afford complete and even support. The mating surfaces of the leaves are fitted with wide fastening material to allow secure fixation of the arm without pressure points. The dimensions allow for protected and stable vascular access sites with the option of adding additional foam padding about such sites and to vulnerable nerves and bones. The device also allows for radiologic imaging and can be quickly undone in an emergency for rapid access. The device is made of material which is hypoallergenic and durable. It can be manufactured in either a disposable or reusable version.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority from U.S. Provisional Application No. 61/221,492, filed Jun. 29, 2009, which is hereby incorporated by reference in its entirety for all purposes. 
    
    
     BACKGROUND 
     1. Field of the Disclosure 
     The disclosure relates to devices for providing support and protection for a patient&#39;s arms during medical procedures. 
     2. Description of the Related Art 
     Often during medical procedures, for example surgery, a patient may be under a general anesthetic or sedated to such an extent that he or she cannot protect or support himself/herself, as well as voice or indicate pain or discomfort to those in care of him/her. In addition, the precision and accuracy of the outcome of the medical procedure may be greatly improved by maintaining the patient in a secure and motionless position. The medical staff is responsible for taking every precaution to protect the patient when he or she is most vulnerable and unable to protect himself/herself. 
     A number of devices have been developed to support and protect the arms of a patient in these circumstances. Rigid arm boards, on which the patient&#39;s arms are placed in various degrees of abduction from their body, often work quite well. However, when medical personnel need the arms positioned close to the body, these arm boards may prove too bulky and can often interfere with access to the patient for both the staff and equipment. In certain laparoscopic surgeries, including robotic assisted laparoscopic surgery, the patient&#39;s arms need to be snuggly adducted to their sides. Often a draw sheet is placed under the patient and the arms are tucked in to the patient&#39;s side. This maneuver can sometimes dislodge sites of vascular access or binding and create pressure points along the patient&#39;s arms, resulting in injury and damage to the nerves, which can be more problematic for the patient&#39;s recovery than the original surgery. 
     Arm sleds or toboggans (named for their resemblance to such items) have also been used with varying success. These are often made of rigid plastic or metal. The “C” shaped end of these devices cradles the arm and the extended portion passes under the mattress beneath the patient. These devices can be cumbersome to position since the mattress on a surgical table is usually secured in the middle from head to toe with a wide strip of VELCRO® brand hook-and-loop fasteners. Most often the sled has to be positioned with the mattress lifted up. If sleds are needed for both arms, the mechanics of the problem become compounded. In addition, these sleds are very rigid, can interfere with the access of the medical staff to the patient, and are not very forgiving of the soft tissue or bones of the patient. Additional padding is often required, and pressure points are common since the weight of the patient&#39;s arm is not evenly distributed. Finally these devices can interfere with radiographic imaging, especially the metal sleds. 
     A number of arm supports have been developed. Many rely on single or multiple straps or strap and buckle variations to secure the arms to the patient&#39;s side. In some models the patient ultimately rests on top of the strap which can press into the skin of the back. In other devices, releasing the device requires moving the patient from side to side. Certain devices support only the forearm. Existing devices may not evenly distribute or support the weight of the arm, which may create pressure points, which in turn may cause injuries. 
     Some devices, for example the device described in U.S. Pat. No. 3,861,666, cover part of the torso of the patient as well as the arms, which may interfere with medical procedures. Other devices, for example the device describe in U.S. Patent Pub. No. 2005/0091749, have protector sections that wrap over the arm from the outside of the arm and that are connected to a surface of the device. The attachment tape that connects the protector sections to the surface is positioned between the patient&#39;s arm and the patient&#39;s body, so it may be difficult to see the attachment tape to secure or release it, especially if the patient&#39;s body is resting on the attachment tape. Also, because the attachment tape connects to a protector section at only one point, an entire protector section must be either secured around the arm or not secured around the arm. Some other devices, for example the device describe in U.S. Patent Pub. 2008/0053464, have sleeves that hold the arms and have straps to secure the device in place. However, these straps may create pressure points, and the sleeves allow an entire arm to only be either covered or uncovered. Also, positioning the arm in the sleeve may require moving the patient&#39;s body. 
     SUMMARY OF THE DISCLOSURE 
     The devices of the invention each have several aspects, no single one of which is solely responsible for its desirable attributes. Without limiting the scope of the invention, certain features will now be discussed briefly. 
     In one embodiment, a patient restraint device comprises a body section dimensioned to receive a torso of a patient, wherein the body section includes first and second lateral edges, a first arm restraint attached to the first lateral edge, wherein the first arm restraint includes a first flexible member that is dimensioned to extend substantially continuously along a first length comprising a length of the patient&#39;s first arm from a location adjacent the patient&#39;s shoulder to a location adjacent the patient&#39;s wrist, and extend about a bottom surface and an outer periphery of the patient&#39;s first arm, and wherein the first arm restraint further includes a second flexible member dimensioned to extend substantially continuously along the first length, and extend about an inner periphery of the patient&#39;s first arm and mate with the first flexible member substantially continuously along the first length. 
     In one embodiment, a patient restraining device comprises a support surface dimensioned to receive a torso of a patient, a flexible inner panel dimensioned to extend about an inner periphery of a first arm of the patient, and a flexible outer panel dimensioned to extend about an outer periphery of the first arm to define a space with the flexible inner panel, wherein the space is dimensioned to receive the first arm. 
     In one embodiment, a method for securing an arm of a patient comprises resting a torso of a patient on a support surface, positioning a first flexible member over a surface of the patient&#39;s arm proximate to the torso along a first length, wherein the first length substantially extends from the patient&#39;s shoulder to the patient&#39;s wrist, and positioning a second flexible member over a surface of the patient&#39;s arm distal to the torso along the first length, thereby positioning the arm in a space defined by the first and second flexible members. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of one embodiment of a soft surgical arm support. 
         FIG. 2A  is an exploded side view of one embodiment of a soft surgical arm support. 
         FIG. 2B  is a side view of one embodiment of a soft surgical arm support. 
         FIG. 3A  is a top down view of one embodiment of a first panel of a soft surgical arm support. 
         FIG. 3B  is a top down view of one embodiment of a second panel of a soft surgical arm support. 
         FIG. 4  is a perspective view of one embodiment of a soft surgical arm support. 
         FIG. 5A  is an exploded side view of one embodiment of a soft surgical arm support. 
         FIG. 5B  is a side view of one embodiment of a soft surgical arm support. 
         FIG. 6A  is a top down view of one embodiment of a first panel of a soft surgical arm support. 
         FIG. 6B  is a top down view of one embodiment of additional panels of a soft surgical arm support. 
         FIG. 7A  is a perspective view of one embodiment of a soft surgical arm support in use with a patient. 
         FIG. 7B  is a perspective view of one embodiment of a soft surgical arm support in use with a patient. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the invention will now be described with reference to the accompanying figures, wherein like numerals refer to like elements throughout. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive manner, simply because it is being utilized in conjunction with a detailed description of certain specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the inventions herein described. 
       FIG. 1  is a perspective view of one embodiment of a soft surgical arm support  100 . In the embodiment shown in  FIG. 1 , the soft surgical arm support  100  includes a first panel  110  and a second panel  120 . In one embodiment, the first panel  110  is made from 5 mm neoprene. Other embodiments may be made include other materials or material of different thicknesses, including other polymers (for example, synthetic rubbers, nylon, and polyester), synthetic fibers (for example, spandex), and/or natural fibers (for example, paper and cotton). Some materials may advantageously not interfere with radiologic imaging of the patent, may be hypoallergenic, and/or may be very durable. Depending on the embodiment, the soft surgical arm support  100  may be disposable or reusable. The other components of the soft surgical arm support  100  may be made from the same materials that the first panel  110  may be made from. 
     The first panel  110  is proximate to the patient and includes a support surface  115 . The first panel  110  may be completely or partially covered by a fleece material  140 . The fleece material  140  may provide extra cushioning for a patient and may provide a surface that is more comfortable to a patient&#39;s skin. The fleece material  140  may act as a fastener, for example the loop surface of a hook-and-loop fastener. The first panel  110  includes one or more first flexible members  113 . A first flexible member  113  may include a portion of the first panel  110  adjacent to an edge of the first panel  110  that may move independently of the second panel  120 . In one embodiment, one or more of the first flexible members  113  extend substantially the entire length of an edge of the first panel  110 . The fleece material  140  may cover all or part of the first flexible member  113 . 
     The second panel  120  includes one or more second flexible members  123 . A second flexible member  123  may include a portion of the second panel  120  near an edge of the second panel  120  that moves independently of the first panel  110 . A second flexible member  123  may extend substantially the entire length of an edge of the second panel  120  and includes a fastener, for example a fastening surface  130 . The fastening surface  130  may extend substantially the entire length of the second flexible member  123 . The first flexible member  113  and the second flexible member  123  may be dimensioned to continuously extend along a length substantially equal to a distance between a patient&#39;s wrist and shoulder. 
     The first flexible member  113  may be coupled to the second flexible member  123 , thereby defining a space  150 . The space  150  may be dimensioned to receive an arm of a patient, and, for example, may substantially be in the shape of an open-ended cylinder. For example, the first flexible member  113  is bent in an arc to form a first part of a circumference of the space  150  and the second flexible member  123  is bent in an arc to form a second part of the circumference of the space  150 . The second flexible member  123  overlaps the first flexible member  113 , and the first flexible member  113  is coupled to the second flexible member  123  at the overlap, for example using the fastening surface  130  and the fleece  140 . Alternatively, the first flexible member  113  may overlap the second flexible member  123 . Also, some embodiments may omit the first flexible member  113  or the second flexible member  123 , and the remaining flexible member may wrap over the arm to be coupled to the support surface  150 . 
     In one embodiment, the first flexible member  113  includes a loop surface, such as the fleece material  140 , and the second flexible member  123  includes a hook surface  130 , though the positions of the hook and/or loop surfaces may be switched. The fasteners on both the first flexible member  113  and the second flexible member  123  may be on the side proximal to the patient or distal to the patient, thereby creating a standing seam that extends away from or a seam that extends toward the patient&#39;s arm when the first flexible member is coupled to the second flexible member  123 . Also, in other embodiments the first flexible member  113  does not overlap the second flexible member  123  or other fasteners are used, including adhesives (e.g., temporary adhesives), buttons, zippers, and laces. 
     The second flexible member  123  and/or the first flexible member  113 , as well as the space  150 , may be substantially the same length as a patient&#39;s arm. This advantageously provides support or protection for substantially the entire arm. For example, the soft surgical arm support  100  may provide an extra layer of protection against cuts, scrapes, punctures, burns, etc., caused by undesired contact with surgical instruments, chemicals, etc. Also, in embodiments in which the fastening surfaces (for example, the fastening surface  130  and the fleece material  140 ) extend substantially the entire length of the second flexible member  123  and the first flexible member  113 , the second flexible member  123  may be coupled to the first flexible member  113  along substantially the entire length of the arm. This may distribute the force holding the arm in place along substantially the entire length of the arm, thereby reducing or eliminating pressure points on the arm. This advantageously reduces the risk of injury to a patient from pressure points, especially a patient who is sedated or unconscious. 
     In use, the soft surgical arm support  100  is positioned on a patient bed. Since the soft surgical arm support  100  may be placed on top, there is no need to lift the bed or mattress to position the soft surgical arm support  100 . A patient is positioned by lying down on the support surface  115 . The first flexible member  113  is positioned around the inner periphery of the arm. The second flexible member  123  is positioned around the outer periphery of the arm, thereby positioning the arm in the space  150 . The second flexible member  123  is coupled to the first flexible member  113  to secure the first flexible member  113  to the second flexible member  123 , thereby securing the arm in place. It will be appreciated that positioning the first flexible member  113  and the second flexible member  123  may require little or no movement of the patient. The patient&#39;s arm may need to be lifted, but the patient&#39;s body does not need to be lifted from the support surface  115  to position the arm in the space. This reduces the risk of injury to the patient, who may be unconscious, heavily sedated, or otherwise unable to voluntarily move, and to medical personnel who would otherwise need to lift the patient. It also reduces the need to have multiple medical personnel lift and move the patient or the need to use equipment, for example a lift, to move the patient. It increases the speed of securing the arm of the patient and further allows the arm to be quickly released to provide rapid access to the arm in an emergency. 
     Moreover, in some embodiments the second flexible member  123  and the first flexible member  113  extend to an upper surface of the circumference of the arm, which advantageously positions the interface between the second flexible member  123  and the first flexible member  113  on top of the arm, increasing the visibility of the interface between the second flexible member  123  and the first flexible member  113 . This further facilitates uncoupling the second flexible member  123  from the first flexible member  113  because the arm and the patient do not need to be moved to uncouple the members and because medical personnel can easily see where to grasp the second flexible member  123  and the first flexible member  113  to uncouple them. This improves access to the arm of the patient, for example to attach a medical device to the arm (such as an IV, a sensor, a bandage, etc.), to perform a medical procedure on the arm, or to release the arm. 
     It will also be appreciated that in some embodiments the first flexible member  113  may be selectively decoupled from the second flexible member  123  along a portion of the interface between the members. This may allow medical personnel to access a portion of the arm while permitting the arm to be supported and protected by the first flexible member  113  and the second flexible member  123 . For example, medical personnel may decouple the first flexible member  113  from the second flexible member  123  adjacent to the forearm to attach an IV to the patient while leaving the first flexible member  113  coupled to the second flexible member  123  along the rest of the length of the arm (including the upper arm and wrist, for example), thereby holding the arm in place and protecting the enclosed portion of the arm while the IV is attached. Medical personal may adjust the location where they decouple the first flexible member  113  and the second flexible member  123  to access the arm in order to account for differences in arm lengths. Furthermore, some fasteners, for example hook-and-loop fasteners, may be coupled around a medical device (for example, a tube or a wire), which allows the arm to be re-enclosed in the space  150  while leaving the medical device attached to the arm and providing additional support to hold the medical device in a desired position. 
       FIG. 2A  is an exploded side view of one embodiment of a soft surgical arm support. In  FIG. 2A , the first flexible members  113  and the second flexible members  123  are in a substantially planar position. The first panel  110  is coupled to the second panel  120  at one or more fastening points  160 , for example by stitching, fasteners, or adhesive. Alternatively, the first panel  110  may be coupled to the second panel  120  along a larger or a smaller surface than is shown by  FIG. 2A , for example along part of or the entire surface between the fastening points  160 . 
       FIG. 2B  is a side view of one embodiment of a soft surgical arm support. In  FIG. 2B , the first flexible members  113  and the second flexible members  123  are positioned to form the spaces  150  that receive the arms of a patient. Though the second flexible members  123  are shown as being coupled to and extending around part of the outer periphery of the first flexible members  113 , in other embodiments the first flexible members  113  may be coupled to and extend around part of the outer periphery of the second flexible members  123 . Some embodiments may allow the first flexible member  113  and the second flexible member  123  to be coupled in either position. Also, some embodiments may allow the first flexible member  113  to be coupled to the second flexible member  123  in a standing seam or may allow for different coupling positions along the length of the interface, for example a position where the first flexible member  113  overlaps the second flexible member  123  along one portion of the arm and where the second flexible member  123  overlaps the first flexible member  113  along another portion of the arm. 
     The dimensions of the fastening surface  130 , the fleece material  140 , the first flexible member  113 , and/or the second flexible member  123  allow the first flexible member  113  and the second flexible member  123  to be coupled together at a range of positions. This range allows medical personnel to selectively vary the size of the space  150  along the entire length of the arm, which allows the fit to be adjusted according to a size of a patient&#39;s arm and/or a desired snugness around the arm. It also allows the space  150  to accommodate padding placed around the arm. For example, in some embodiments if a larger space  150  is desired, the first flexible member  113  may be coupled to the second flexible member  123  in a position when there is minimal overlap of the fastening surfaces. If a smaller space is desired, the first flexible member  113  may be coupled to the second flexible member  123  in a position where there is more overlap. Also, the range of positions may allow the size of the space  150  to vary along all or part of the length of the arm (for example, the space may be wider near the bicep and narrower near the wrist) so that the arm is snugly enclosed along the entire length of the arm. This advantageously reduces pressure points on the arm by more evenly distributing the pressure along the entire length of the arm. In the embodiment shown in  FIGS. 2A-2B , the dimensions of the fleece allow the range of overlaps to extend from minimal overlap to an overlap greater than the width of the surface of the first flexible panel  113 . 
       FIG. 3A  is a top down view of one embodiment of a first panel  110  of a soft surgical arm support, and  FIG. 3B  is a top down view of one embodiment of a second panel  120  of a soft surgical arm support. Though these figures illustrate the dimensions of one embodiment, it is to be understood that all dimensions are provided by way of example rather than limitation, and any other suitable dimensions in addition to and/or in alternative to the illustrative dimensions of the described embodiment may be used in other embodiments. The first panel  110  measures about 34 inches long and about 15 inches wide. The second panel  120  measures about 39 inches long and about 15 inches wide. One panel is about 5 mm thick and the other panel is about 3 mm thick. Each end of the second panel includes an approximately 8 inch long by 14 inch wide piece of a fastening surface  130 . In this embodiment, the fastening surface  130  is offset from the lateral edge by about 1 inch and from the top and bottom edges by about ½ inch. The second panel  120  is coupled to the first panel  110 , for example by sewing, at a point about 15 inches from each lateral edge. In other embodiments, the panels may be attached to each other with any other suitable fastener, for example buttons, zippers, adhesives, hook and loop fasteners, and/or laces. 
     The soft surgical arm support  100  may be placed on a table so that the lower edge of the soft surgical arm support  100  is positioned approximately at the level of the wrist when at the patient&#39;s side and the soft surgical arm support  100  is centered on the table from side to side. The second flexible members  123  may be allowed to hang over the edges of the table as the patient is moved into position. The patient is positioned on the table and on the soft surgical arm support  100 . IV access on the patient can be placed and secured. Additional padding may be used, for example around vulnerable sites such as IV sites, soft tissue, nerves, and bones. The patient&#39;s arms and any additional padding are placed between the second flexible members  123  and the first flexible members  113 . The second flexible members  123  wrap around the outside of the arm and the first flexible members  113  wrap around the inside of the arm. The device may encase all or part of the arm and provide even and uniform support from the wrist to just above the elbow or substantially to the shoulder. 
       FIG. 4  is a perspective view of one embodiment of a soft surgical arm support  400 . In the embodiment shown in  FIG. 4 , the device includes a first panel  410  and two additional panels  470 . It will be appreciated that in other embodiments the soft surgical arm support  400  may include another numbers of panels. The first panel  410  is proximate to the patient and includes a support surface  415 , though in other embodiments one or both of the additional panels  470  may be proximate to the patient. The first panel  410  includes one or more first flexible members  413 . The first flexible members  413  each include a fastening surface  432 . The additional panels  470  are coupled to a distal surface of the first panel  410 . The additional panels  470  include a fastening surface  430  that may engage the fastening surface  432  of the first flexible members  413 . 
       FIG. 5A  is an exploded side view of one embodiment of a soft surgical arm support  400 , and  FIG. 5B  is a side view of one embodiment of the soft surgical arm support  400 . The additional panels  470  are coupled to the first panel  410  at the fastening points  460 . As shown in  FIG. 5B , a first flexible member  413  may be bent or curved into a substantially arc shape and an additional panel  470  may be bent or curved into a substantially arc shape that contacts the first flexible member  413  in order to define a space  450  dimensioned to receive an arm of a patient. It will be appreciated that the first flexible member  413  and the additional panel  470  may overlap, and the dimensions of the fastening surfaces  430 ,  432  may allow the extent of the overlap to vary, thus allowing the size of the space  450  to vary. 
       FIG. 6A  is a top down view of one embodiment of a first panel  410  of a soft surgical arm support  400 , and  FIG. 6B  is a top down view of one embodiment of the additional panels  470  of a soft surgical arm support  400 . Again, though these figures illustrate the dimensions of one embodiment, it is to be understood that all dimensions are provided by way of example rather than limitation, and any other suitable dimensions in addition to and/or in alternative to the illustrative dimensions of the described embodiment may be used in other embodiments. The first panel  410  is about 34 inches long and about 15 inches wide. Each end of the first panel  410  includes an approximately 6 inch long and 14 inch wide piece of a fastening surface  432 . The fastening surface  432  is offset from the lateral edges of the first panel  410  by 2 inches and from the top and bottom edges of the first panel  410  by ½ inch. 
     The additional panels  470  each are about 15 inches long and about 15 inches wide. Each additional panel  470  has an approximately 8 inch long by 14 inch wide piece of a fastening surface  430 . The fastening surface  420  is offset from the lateral edge of the additional panel  470  by about 1 inch and from the top and bottom edges of the additional panel  470  by about ½ inch. The additional panels  470  are coupled to the first panel  410 , one at each fastening point  460 , which are about 11 inches from the lateral edge of the first panel  410 . The fastening surfaces  430  of the additional panels  470  are oriented in the same direction. The dimensions of the fastening surface  420  and the fastening surface  430  in this allow an overlap range of approximately 14 inches when the additional panel  470  is coupled to an end of the first panel  410 , though other embodiments may have different ranges. This range may be used to adjust the snugness or tightness of a fit around a patient&#39;s arm. 
       FIG. 7A  is a perspective view of one embodiment of a soft surgical arm support in use with a patient. In  FIG. 7A , the first flexible members  113  are positioned around the inner circumference of the respective arms of the patient. In the embodiment shown, the second flexible members  123  are extending outward. The first flexible members  113  and the second flexible members extend substantially from the patient&#39;s wrists to the patient&#39;s shoulders. 
       FIG. 7B  is a perspective view of one embodiment of a soft surgical arm support in use with a patient. In  FIG. 7B , the second flexible members  123  have been folded over the outside of the first flexible members  113  and the arms of the patient. The arms of the patient are substantially enclosed by the first flexible members  113  and the second flexible members  123 . Because the first flexible members  113  and the second flexible members  123  are coupled together on the upper peripheries of the patient&#39;s arms, the body and arms of the patient do not need to be moved when the flexible members  113 ,  123  are coupled together. Also, substantially the entire arm is enclosed, providing protection for the arm. Furthermore, because the flexible members  113  and  123  are coupled along substantially the entire length of the arm, the pressure on the arm is more evenly distributed along the length of the arm, thereby reducing pressure points. Moreover, the fit around the arm may be selectively adjusted along substantially the entire length of the arm (e.g., wider at the bicep and forearm, narrower at elbow and wrist) so that the fit is snug along the length. 
     Although the foregoing invention has been described in terms of certain embodiments, other embodiments will be apparent to those of ordinary skill in the art from the disclosure herein. Moreover, the described embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions. Indeed, the novel devices described herein may be embodied in a variety of other forms without departing from the spirit thereof. Accordingly, other combinations, omissions, substitutions and modifications will be apparent to the skilled artisan in view of the disclosure herein. Thus, the present invention is not limited by the preferred embodiments, but is defined by the appended claims.