Abstract:
Systems and methods for providing a radiopaque shield affixed to a medical device hangar. Such systems and methods reduce radiation exposure to circulating medical staff during fluoroscopy procedures and reduce equipment clutter and cost.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This utility patent application claims benefit of U.S. Provisional Application Ser. No. 62/087,282, filed Dec. 4, 2014, which is incorporated herein in its entirety by reference thereto. 
     
    
     BACKGROUND OF THE DISCLOSURE 
       [0002]    During a fluoroscopy procedure a cardiologist will direct circulating staff such as a nurse to “push a drug” to a patient. An intravenous (IV) pole holding the necessary medications normally sits at the head of a table holding the patient. The nurse must approach the IV pole to administer the drugs and therefore may receive a very large dose of scatter radiation if the doctor is taking an X-Ray while the nurse is at the IV pole. This may happen because the doctor is focused on the patient and the procedure rather than on a location of the nurse. More specifically, if the physician&#39;s foot is on a fluoroscope pedal while the nurse is at the IV pole, the nurse will receive a high dose of scatter radiation during a normal X-ray (3-5 seconds fluoroscopy time). Aside from the potentially adverse impact on staff members&#39; health, government regulations limit lifetime exposure to radiation. Thus, unnecessary exposures to scatter radiation can result in premature removal of experienced staff from fluoroscopy procedure rooms where they are most needed. 
         [0003]    Moreover, equipment clutter in a procedure room can become a serious problem, especially during emergency procedures. Some equipment simply gets in the way of staff during crowded room emergency situations and is often pushed out of the way, even equipment intended for staff safety. Also, due to continual repositioning, the needed equipment is rarely in proper position when needed, so it commonly goes unused during an emergency. 
         [0004]    A system that can be readily attached to, for instance, existing IV poles while allowing adequate space for other medical devices attached to a pole would be very useful and is urgently needed in fluoroscopy procedure rooms. The needed solution would provide a radiation shield near ionizing radiation sources to reduce radiation exposure to circulating staff, which would also allow a cardiologist to focus on a case rather than on staff location during fluoroscopy. Also, the needed solution would reduce equipment clutter and related inventory cost. 
       BRIEF SUMMARY OF THE DISCLOSURE 
       [0005]    The inventors have unexpectedly discovered several modular radiation shielding systems useful in medical procedure rooms, particularly during fluoroscopy. Thus, the present disclosure is directed in general to these versatile, mobile, scatter radiation reduction systems. 
         [0006]    According to one aspect of the present disclosure, a radiopaque system for use with medical equipment hangars may include a radiation shield having a first side and a second side and a radiopaque material interposed therebetween, the radiopaque material being at least 0.2 millimeters (mm) in thickness; and at least two attachment assemblies being asymmetrically disposed on the radiation shield, the attachment assemblies each being configured to adjustably connect the radiation shield to an equipment carrier, wherein the second side defines a face and the attachment assemblies depend from about two inches to about five inches from the face; wherein the radiation shield and the attachment assemblies are adapted to be coupled to one or more connection members of the equipment carrier. 
         [0007]    In this aspect, the radiation shield may be rectilinear and rectangular in form, and the first side and the second side may include a weldable thermoplastic, which may be a polyethylene such as high density polyethylene. The radiopaque material may include lead, antimony, tin, barium, bismuth, cesium and/or tungsten. The lead, for instance, may be between about 0.2 mm to about 2 mm in thickness. 
         [0008]    Also in this aspect, each of the attachment assemblies may conform to a shape of respective connection members of the equipment carrier. At least one of the connection members may be a rod or a limb. 
         [0009]    Still further, the radiation shield may have a perimeter, and the attachment assemblies may be two or more clamps adapted to be coupled to one or more connection members of the equipment carrier. The clamps may be spaced apart from each other at divergent, different, or variable distances from the perimeter. 
         [0010]    Also in this aspect, additional medical or other equipment may be located near the second side and set off from about two inches to about five inches from the face. 
         [0011]    In this aspect, the system may also be adapted for vertical alignment on the equipment carrier in a first configuration and for inversion on the equipment carrier in a second configuration. Still further, the system may be adapted for substantially horizontal alignment on the equipment carrier in a third configuration. 
         [0012]    In another aspect of the disclosure, a radiation shield assembly for use with medical equipment may include a radiation guard having a first face and a second face and a radiopaque material interposed therebetween, the radiopaque material being between about 0.2 mm to about 2 mm in thickness; and at least two connection assemblies operably disposed on the radiation guard, the connection assemblies being configured to adjustably connect the radiation guard to a medical device hangar, the radiation guard and the medical device hangar being spaced apart from each other; wherein at least one of the connection assemblies is adapted to be coupled to a connection member of the medical device hangar such that the radiation guard is in a configuration selected from the group consisting of a substantially vertical alignment on the medical device hangar, a substantially horizontal alignment on the medical device hangar, and an inverted position on the medical device hangar. 
         [0013]    In this aspect, the first face and the second face may include thermoplastic material and the radiopaque material may be lead or another radiodense material. The radiation shield may be rectilinear and rectangular in form and define a perimeter. Two connection assemblies may be spaced apart from each other at different distances from opposite portions of the perimeter. The connection assemblies may be two or more clamps asymmetrically attached to the radiation shield at different distances from the perimeter. 
         [0014]    Also in this aspect, the radiation guard and the medical device hangar may be spaced apart from each other from about two inches to about five inches such that the radiation guard does not interfere with equipment disposed on the medical device hangar. 
         [0015]    In a further aspect of the disclosure, a radiopaque medical equipment system may include a mobile carrier; a radiopaque radiation shield having a first face and a second face, the radiopaque shield including radiodense material at least 0.2 mm in thickness to shield an operator from scatter radiation; and an attachment assembly disposed on the radiation shield, the attachment assembly connecting the radiation shield to the mobile carrier and depending from about two inches to about five inches from the second side. 
         [0016]    In this aspect, the attachment assembly may be two connection assemblies asymmetrically attached to the radiation shield at different distances from a perimeter of the radiopaque radiation shield. The attachment assembly may be a press-fit, quick-release mechanism and/or a gravity hangar, both of which permit the radiopaque radiation shield to be easily removed from, or installed with, the mobile carrier. 
         [0017]    The various embodiments described herein are non-limiting examples. Additional aspects of the present subject matter are set forth in, or will be apparent to, those of ordinary skill in the art from the detailed description herein. Modifications and variations to the specifically illustrated, referred and discussed features and elements hereof may be practiced in various embodiments; therefore, the disclosure is broader in scope than the described embodiments. Variations may include, but are not limited to, substitution of equivalent means, features, or steps for those illustrated, referenced, or discussed, and the functional, operational, or positional reversal of various parts, features, steps, or the like. Those of ordinary skill in the art will better appreciate the features and aspects of such variations upon review of the remainder of the specification. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    A full and enabling disclosure of the present subject matter, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which: 
           [0019]      FIG. 1  is a side elevational view of a modular system according to an aspect of the disclosure; 
           [0020]      FIG. 2  is a front elevational view of the system as in  FIG. 1  shown in an intended use environment; 
           [0021]      FIG. 3  is a partial, rear, elevational view of the system as in  FIG. 1 ; 
           [0022]      FIG. 4  is a schematic view of the system as in  FIG. 1  shown being attached to a working component (partially shown); 
           [0023]      FIG. 5  is a perspective view of the system as in  FIG. 4 , including an exploded, partial inset view of an aspect of the disclosure; 
           [0024]      FIG. 6  is rear, elevational view of the system as in  FIG. 5 ; and 
           [0025]      FIG. 7  is a perspective view of a radiodense system according to another aspect of the disclosure, including partial inset views of some features of the disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    Detailed reference will now be made to the drawings in which examples embodying the present subject matter are shown. The detailed description uses numerical and letter designations to refer to features of the drawings. 
         [0027]    As required, detailed embodiments of the present disclosure are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary. The figures are not necessarily to scale, and some features may be exaggerated to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the embodiments and their equivalents disclosed herein. 
         [0028]    It is an object of the present disclosure to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative. Any discussion of the prior art in the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field. 
         [0029]    In working environments for which the embodiments of the disclosure are intended, several components and related pieces of equipment may be used in conjunction with the disclosed embodiments. For instance, Cardio-TRAP® brand left radial access, right room operation, lower extremity peripheral platforms, such as those described in PCT application serial number PCT/US14/34788 may be used in intended environments of the present disclosure. The foregoing PCT patent application is hereby incorporated by reference herein in its entirety. 
         [0030]    Turning now to  FIG. 1 , according to an embodiment of the disclosure, a modular, radio-opaque, invertible shield system designated in general by the number  10  is shown. The radiation system  10  may broadly include a radiation shield, guard or planar member  12 , a first mounting assembly  14 , a second mounting assembly  16 , and a medical device or equipment hangar  18 . The hangar  18  may include a pole or rod  20 , a base or stand  22 , and one or more wheels  24 . Alternatively, the hangar  18  can be an intravenous (IV) pole upon which the radiation shield  12  can be located, as explained below. 
         [0031]    As  FIG. 1  further shows, the shield  12  may have a first side or face  26  and an opposing second side or face  28 . Here, one or both of the first and second mounting assemblies  14 ,  16  on face  28  may be connected, attached or mated to the rod  20  and/or to a catch, hook, loop or the like of the hangar  18 , such as a connection member or receiver  38 . As will be explained in detail below, the mounting assemblies  14 ,  16  may include screws, bolts with nuts, snaps, cord, quick-release mechanisms or other connection members for attaching or connecting the shield  12  to the hangar  18 . Further, as described in greater detail below, the mounting assemblies  14 ,  16  may be set off from the pole  20  to accommodate other equipment  7  that may be on the hangar  18 . 
         [0032]      FIG. 2  most clearly shows the face  26  of the shield  12 . In this example, the system  10  is positioned near a patient  1  being imaged by a fluoroscopy machine  3  with a Cardio-TRAP® brand platform  5  serving to protect an attending cardiologist (not shown). More particularly,  FIG. 2  shows that the shield  12  may be mated to the rod  20  of the hangar  18 , which is positioned near the patient  1  using the mobile stand  22 . A technician or nurse  11  may, for instance, stand behind the shield  12  to intravenously administer medications to the patient  1 , or to monitor other equipment on the hangar  18 . In this example, the shield  12  measures approximately 24 inches×32 inches and may be radiopaque or radiodense to block scatter radiation  9  being redirected or scattered from the patient  1 . More specifically, the exemplary shield  12  blocks more than 90% of the scatter radiation  9  from reaching the staff member  11  positioned behind the shield  12  as discussed in additional detail with respect to  FIG. 5  below. 
         [0033]    With reference now to  FIG. 3 , the face  28  of the shield  12  and the rod  20  of the hangar  18  are most clearly shown in a first, substantially vertical configuration. Also, as introduced above, the system  10  easily accommodates other equipment  7  that may be on the hangar  18 . In other words, the shield  12  may be, for example, connected to the rod  20  without interfering with the preexisting equipment  7 . Likewise, the shield  12  will not prevent attaching equipment  7  with the shield  12  in place first. 
         [0034]    In  FIG. 4  the system  10  is shown schematically from one side being positioned for mating or connection with the rod  20  of the hangar  18  (partially shown for detail). As shown, the hangar  18  may have one or more receivers  38 , each of which may have a rod or limb  64 . The exemplary shield  12 , as introduced, may have sides  26 ,  28  and be substantially planar in shape. The shield  12  may also have a top edge or side  44  and a bottom edge or side  46 . Raised corners, for instance, may be provided at or on the edges  44 ,  46  such that the right radial base of the Cardio-TRAP® as described in application serial number PCT/US14/ 34788  may be hung on the shield  12  to prevent a hanging component from sliding off. 
         [0035]    Also shown in the example of  FIG. 4 , the first mounting assembly  14  may include an extension component, arm or the like, such as bracket  30 , and a closure or securement component, such as screw assembly  32 . Likewise, the second mounting assembly  16  may include an extension component, arm or the like, such as bracket  34 , and a closure or securement component, such as screw assembly  36 . The mounting assemblies  14 ,  16  may be spaced from the face  28  approximately 2 inches to 5 inches as indicated by element number  40 . This off-set  40  will provide space to accommodate other equipment that may be attached to the hangar  18 . Although both mounting assemblies  14 ,  16  are shown with approximately equal off-sets  40 , the disclosure is not limited to that arrangement. One of the assemblies could be off-set 2 inches and one could be off-set 5 inches to accommodate a particular hangar, for instance. 
         [0036]      FIG. 4  further shows that mounting assembly  14  is spaced at a first distance  48  from edge  44  while mounting assembly  16  is spaced at a second distance  50  from edge  46 . In this example, first distance  48  may be approximately 2 inches and second distance  50  may be approximately 4 inches. Thus, the shield  12  may be higher or lower relative to the hangar  18  depending on how the shield  12  is oriented or inverted in a second configuration. Here, the mounting assembly  14  is spaced apart at distance  42  from the mounting assembly  16 . Distance  42  may be from 10 to 30 inches where the shield  12  may be about 36 inches in length and about 30 inches in width, although the shield  12  may be smaller or larger to accommodate specific user requirements, such as about 12 inches in length or about 10 inches in width. Furthermore, other mounting points or holes (not shown) may be provided and off-set by as much a six inches on an exemplary 24″×32″ shield to permit greater adjustment. 
         [0037]    With reference now to  FIG. 5 , the system  10  is shown in perspective and most clearly shows its mounting assemblies  14  and  16 . In particular, the bracket  30  and a portion of the screw assembly  32  of mounting assembly  14  are shown. As introduced above, the screw assembly  32  is off-set from the face  28  of the shield  12  by the off-set  40 . Similarly, the bracket  34  and the screw assembly  36  of mounting assembly  16  also are clearly shown in  FIG. 5 . The screw assembly  32  includes a grip or knurled knob  52  and a contact or closure end  54 . The bracket  34  includes a gap or capture feature  56  to hold the rod  20  or the limb  64 . Specifically, once the capture features  56  are positioned about respective rods  20  or limbs  64 , the user may tighten or clamp the respective clamp assemblies  32 ,  36  to attach the radio-opaque guard  12  to the equipment hangar  18 . In this example, the closure end  54  will press-fit against a portion of the rod  20  or limb  64  to press that portion into the capture feature  56  and render the system  10  stationary. To adjust or remove the shield  12 , the user may loosen or unclamp the assemblies  32 ,  36 . 
         [0038]      FIG. 5  also shows in an exploded inset a partial view of the radio-opaque guard  12 , which has radiodense material  66  heat-welded or pressure-welded between two sheets or pieces of approximately ⅛″ thick high density polyethylene (HDPE), in this case, the sides  26 ,  28  of the shield  12 . Embodiments including the material  66  to protect staff members from scatter radiation from a patient receiving fluoroscopy may weigh less than twelve pounds using approximately 0.5 millimeters (mm) of lead and up to approximately thirty pounds using up to 2 mm of lead. The material  66  may be lead, antimony, tin, barium, bismuth, cesium, tungsten, or any suitable radiodense material sufficient to absorb, reduce, inhibit, attenuate, or block ionizing radiation emanating from a patient being x-rayed. 
         [0039]    In  FIG. 6 , the system  10  is shown rotated 90 degrees in a third substantially horizontal configuration compared to, for instance, the first configuration or orientation of  FIGS. 3 and 4 . Here, sides or edges  44 ,  46 ,  68 ,  70  complete a perimeter of the shield  12 . The mounting assemblies  14 ,  16  are spaced apart from each other on face  28  at the desired distance  42 . The assembly  14  is at distance  48  from edge  44  and assembly  16  is at distance  50  from edge  46 . In this example, the mounting assemblies  14 ,  16  are spaced asymmetrically from edges  44 ,  46  while spaced approximately equidistant from sides  68 ,  70 . However, one or both of the mounting assemblies  14 ,  16 , or an additional mounting assembly, could be attached to the shield  12  at, for instance, apertures  72 . 
         [0040]      FIG. 6  also most clearly shows knobs  52  and  58  of their respective clamp assemblies  36 ,  32 . As shown, the clamp  36  includes the contact portion  54  and the clamp  32  includes contact portion  60 . As introduced above, the limb  64  (in phantom for clarity) is captured, for example, between contact portion  60  and shoulder  62 . 
         [0041]    Turning to  FIG. 7 , another embodiment of a scatter radiation shielding system  110  includes a radiodense screen or shield  112 , mounting assemblies  114  and  116  and a mobile stand or base  118  having wheels or rollers  122 . The shield  112  may have sides  126 ,  128  or may be a unitary piece made of a radiopaque material. If separately included, as indicated by element number  166 , the radiopaque material may include lead, antimony, tin, barium, bismuth, cesium, tungsten, or any suitable radiodense material sufficient to absorb, reduce, inhibit, attenuate, or block ionizing radiation—schematically shown and labeled element  19 —from reaching a staff member  111  positioned behind the shield  112 . The shield  112  may weigh between about twelve pounds to about thirty pounds and utilize approximately 0.5 mm to about 2 mm of radiopaque material  166 . 
         [0042]    As shown in detail in a first inset of  FIG. 7 , a quick-release assembly  132  may be located between the base  118  and the shield  112 . Here, the assembly  132  is off-set by distance  140 , which is at least the distance of a mounting assembly  116 . As shown in a second inset, the mounting assembly  116  may be a gravity hangar wherein the shield  112  can be removed from the base  118  at assembly  132  and placed with or on another piece of equipment, or the assembly  116  can be used to further secure the shield  112  to the base  118  or to other components, and/or other components may be attached using the assembly  116 . More particularly, the assembly  116  may be hung on a pole or rod  164 , as shown in the inset, and the weight of the shield  112  will press down upon the pole  164  as indicated by the bold, downward facing arrow. The shield  112  may incline or tilt slightly, as indicated by the bold, curved arrow, until the face  128  contacts and stops at a portion of the base stand  118  (shown schematically in the inset for clarity). 
         [0043]    In some embodiments, as further shown in  FIG. 7 , the distance  140  will be at least about 2 inches to about 6 inches, particularly 5 inches, to accommodate other equipment  17  on the stand  118 . As briefly introduced above, the assembly  132 , shown most clearly in the inset, may include a trigger or latch  136  and a channel or press-fit orifice  150  to receive a key or press-fit limb  120  from the assembly  114 . The key  120  may have a receiver or notch  156 , and the latch  136  may further include a protrusion, pin or catch  152  to nest in the receiver  156 . Specifically, the radio-opaque guard  112  may be pressed onto the hangar  118  by pushing the key  120  and the latch  136  together. The latch  136  will have a spring constant to permit the pin  152  to be momentarily displaced in a first or stressed state, as indicated by the double-headed arrow, until the pin  152  centers on or aligns with the notch  156  and returns to a resting or second state in the notch  156 . To adjust or remove the shield  112 , a user may activate or pull on the latch  136 , again as indicated by the double-headed arrow, to release the pin  152  from the notch  156 . Those skilled in the art will understand that the assembly  132  can be arranged nearer the stand  118 , that the key  120  and the latch  136  may be reversed, and/or that similar key and latch assemblies may be provided both nearer to the stand  118  and as shown in this example. 
         [0044]    Detailed embodiments of the present disclosure have been described herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the inventions herein that may be embodied in various forms. It will be appreciated that many modifications and other variations stand within the intended scope of this disclosure as claimed below. Furthermore, the foregoing description of various embodiments does not necessarily imply exclusion. For example, “some” embodiments may include all or part of “other” and “further” embodiments within the scope of this disclosure. In addition, “a” does not mean “one and only one;” “a” can mean “one and more than one.” Furthermore “first”, “second” and like terminology may be used herein as differentiating descriptors and may not mean primary, secondary and the like, nor do such terms dictate temporal limitations, unless expressly stated.