Patent Publication Number: US-2022233384-A1

Title: Arm support apparatus

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 62/677,266 filed on May 29, 2018, Canadian Application No. 3,006,471 filed on May 29, 2018, and U.S. Provisional Application No. 62/836,811 filed on Apr. 22, 2019, and the entire contents of each are hereby incorporated herein by reference. 
    
    
     FIELD 
     The present disclosure relates generally to apparatuses for and methods of supporting a human patient&#39;s arm during medical procedures, and more particularly to gaining access to a human patient&#39;s radial artery during cardiac catheterization procedures. 
     BACKGROUND 
     The following paragraphs are not an admission that anything discussed in them is prior art or part of the knowledge of persons skilled in the art. 
     United States Publication No. 20160038365 describes systems and methods for left radial access, right room operation peripheral interventions that include left radial bases to stabilize a left arm of a cardiac patient across a midsagittal plane, transradiant right radial bases to position a right arm of the patient, and radiodense radiation reduction barriers located between the patient and a doctor. 
     U.S. Pat. No. 9,763,843 describes a medical apparatus for use in supporting a patient lying in a supine position during a radial cardiac catheterization procedure. More particularly, an arm board is described for use with a patient&#39;s arm during a radial cardiac catheterization procedure. The arm board has a base member having a substantially planar support surface on which the patient&#39;s arm can be stabilized during a catheterization procedure and at least one shield member affixed to the base member and extending away from the support surface. The base member has both a radiolucent portion and a radiopaque portion and the shield member is a radiopaque material, thereby reducing and/or eliminating a doctor&#39;s exposure to radiation during radial cardiac catheterization procedures without impairing the ability to obtain the necessary medical images. 
     INTRODUCTION 
     The following summary is intended to introduce the reader to various aspects of the applicant&#39;s teaching, but not to define any invention. 
     According to some aspects of the present disclosure, an apparatus for supporting an arm of a human patient during a medical procedure is disclosed. The apparatus can include: a base including a medial portion that is configured to lie between the human patient and a table on which the human patient is supported, and a lateral portion that extends laterally from the medial portion; an arm pad positioned on the lateral portion of the base, the arm pad extending longitudinally between first and second ends; a first barrier for shielding scatter radiation during the medical procedure, the first barrier mounted to the base and positioned laterally intermediate the medial and lateral portions thereof, the first barrier extending upwardly from the base to above the arm pad; and a second barrier for shielding scatter radiation during the medical procedure, the second barrier mounted to the lateral portion of the base and extending downwardly therefrom. 
     According to some aspects of the present disclosure, an apparatus can include: a base; a first barrier mounted to the base for shielding scatter radiation, the first barrier extending upwardly from the base; a second barrier mounted to the base for shielding scatter radiation, the second barrier extending downwardly from the base; and an arm pad on the base positioned laterally intermediate the first and second barriers, the arm pad including a proximal portion for supporting an arm of a human patient, and a central portion for supporting a hand of the arm. 
     According to some aspects of the present disclosure, a method of supporting an arm of a human patient is disclosed. The method can include: positioning a base to lie between the human patient and a table on which the human patient is supported, the base including a lateral portion that extends laterally from the table; placing the arm of the human patient on an arm pad that is positioned on the lateral portion of the base; shielding scatter radiation with a first barrier, the first barrier mounted to the base and positioned laterally intermediate the lateral portion and the human patient, the first barrier extending upwardly from the base to above the arm pad; and shielding scatter radiation with a second barrier, the second barrier mounted to the lateral portion of the base and extending downwardly therefrom. 
     Other aspects and features of the teachings disclosed herein will become apparent, to those ordinarily skilled in the art, upon review of the following description of the specific examples of the present disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The drawings included herewith are for illustrating various examples of apparatuses and methods of the present disclosure and are not intended to limit the scope of what is taught in any way. In the drawings: 
         FIG. 1  is a perspective view of a first example of an arm support apparatus; 
         FIG. 2  is a top view of the apparatus of  FIG. 1 ; 
         FIG. 3  is a side sectional view taken along line  3 - 3  in  FIG. 2 ; 
         FIGS. 4 and 5  are side and end views, respectively, of the apparatus of  FIG. 1 ; 
         FIGS. 6, 7, 8 and 9  are perspective, side, bottom and end views, respectively, of an arm pad of the apparatus of  FIG. 1 ; 
         FIGS. 10, 11, 12, 13 and 14  are first and second perspective, top, side and end views, respectively, of the apparatus of  FIG. 1 , shown with the arm pad removed; 
         FIG. 15  is a perspective view of the apparatus of  FIG. 1  and a human patient supported by a table; 
         FIG. 16  is a perspective view of a second example of an arm support apparatus; 
         FIGS. 17 and 18  are top and end views, respectively, of the apparatus of  FIG. 16 ; 
         FIG. 19  is a perspective view of a left wing of the apparatus of  FIG. 16 ; 
         FIG. 20  is a detailed view of a portion of  FIG. 19 ; 
         FIG. 21  is an exploded view of the apparatus of  FIG. 16  in combination with arm pads; and 
         FIGS. 22 and 23  are perspective views of the apparatus of  FIG. 16 , the arm pads and a human patient supported by a table. 
     
    
    
     DETAILED DESCRIPTION 
     Various apparatuses or methods will be described below to provide an example of an embodiment of each claimed invention. No embodiment described below limits any claimed invention and any claimed invention may cover apparatuses and methods that differ from those described below. The claimed inventions are not limited to apparatuses and methods having all of the features of any one apparatus or method described below, or to features common to multiple or all of the apparatuses or methods described below. It is possible that an apparatus or method described below is not an embodiment of any claimed invention. Any invention disclosed in an apparatus or method described below that is not claimed in this document may be the subject matter of another protective instrument, for example, a continuing patent application, and the applicant(s), inventor(s) and/or owner(s) do not intend to abandon, disclaim or dedicate to the public any such invention by its disclosure in this document. 
     When performing a cardiac catheterization using the radial artery for access, radiation exposure to the operating physician can be higher than during use of the femoral artery. In the context of increasing popularity of radial access, this greater radiation exposure for operating physicians performing cardiac catheterization is of concern, particularly given evidence suggesting a higher incidence of tumors among invasive cardiologists. 
     Current equipment, such as lead aprons and above-table shields, provide some protection, but it is desirable for operator radiation exposure to be reduced further, especially for cases using radial access. Existing cardiac catheterization labs can use non-specific arm support devices when gaining access to the radial artery. These devices can be clumsy, unprofessional, and uncomfortable for the patient and can provide little or no additional radiation protection. While more specific arm support devices have been created, they have many limitations, which can include: they can offer only modest, incremental radiation protection for the operating physician; they can increase patient and operator radiation dose and degrade the image quality due to the relative radiopacity and thickness of the materials used; and they can be inconvenient as they can require being removed between cases, or once the procedure begins, to avoid contaminating the sterile field. 
     The present disclosure relates to arm support apparatuses that are well suited for use in gaining access to a human patient&#39;s radial arteries during cardiac catheterization procedures. 
     Referring to  FIGS. 1 and 2 , an example of an apparatus for supporting an arm of a human patient during a medical procedure is shown generally at reference number  10 . The apparatus  10  as illustrated includes a base  12 , and arm pad  14 , a first barrier  16  and a second barrier  18 . In use, the arm pad supports the right arm of the human patient, and the first and second barriers  16 ,  18  can shield an attending staff member from scatter radiation during the medical procedure. 
     In the example illustrated, the base  12  includes a medial portion  26  and a lateral portion  28 . The medial portion  26  is configured to lie between the human patient and a table on which the human patient is supported. The lateral portion  28  extends in a lateral direction  22  from the medial portion  26 . To aid with understanding,  FIG. 1  includes a directional legend, in which a longitudinal direction  20 , the lateral direction  22 , and a vertical direction  24  are shown. 
     In the example illustrated, the arm pad  14  is positioned on the lateral portion  28  of the base  12 . The arm pad  14  extends in the longitudinal direction  20  between first and second ends  30 ,  32 . In some examples, the arm pad  14  rests on the lateral portion  28 , without being attached. This can allow adjustment of the position of the arm pad  14  according to patient&#39;s arm length. Therefore, the apparatus  10  can be customized to the patient&#39;s size without needing to move the patient or the base  12  underneath them. In other examples, the arm pad  14  can be fixed to the lateral portion  28 . 
     In the example illustrated, the first barrier  16  is mounted to the base  12  and is positioned intermediate the medial and lateral portions  26 ,  28  in the lateral direction  22 . The second barrier  18  is mounted to the lateral portion  28 . The first barrier  16  extends upwardly from the base  12  in the vertical direction  24  to above the arm pad  14 . The second barrier  18  extends downwardly from the base  12  in the vertical direction  24 . 
     In the example illustrated, the arm pad  14  includes a proximal portion  34  adjacent to the first end  30 , a distal portion  36  adjacent to the second end  32 , and a central portion  38  arranged between the proximal and distal portions  34 ,  36 . In use, the proximal portion  34  supports the arm of the human patient, and the central portion  38  supports a hand of the arm. The portions  34 ,  36 ,  38  each include an upper surface  40 ,  42 ,  44 , respectively. In the example illustrated, each of the upper surfaces  40 ,  42 ,  44  is spaced above the lateral portion  28  of the base  12  in the vertical direction  24 . 
     Referring to  FIGS. 3 and 4 , the lateral portion  28  of the base  12  extends in the longitudinal direction  20  to support a length of the arm pad  14 . The first and second barriers  16 ,  18  are each shown arranged longitudinally intermediate of the arm pad  14 . Furthermore, the central portion  38  of the arm pad  14  is shown arranged within a longitudinal extent of each of the first and second barriers  16 ,  18 . With this arrangement, in use, the first and second barriers  16 ,  18  provide shielding of radiation in the vicinity of the hand of the human patient. 
     As shown in  FIG. 3 , the arm pad  14  can further include a radiopaque panel  46 . In the example illustrated, the panel  46  is arranged in the central and distal portions  38 ,  36  of the arm pad  14 , horizontally and adjacent to the lateral portion  28  of the base  12 . In the example illustrated, the panel  46  can extend generally laterally between the first and second barriers  16 ,  18  to provide shielding of radiation in the vicinity of the hand of the human patient. 
     Referring to  FIG. 5 , the lateral portion  28  of the base  12  extends laterally to support a width of the arm pad  14 . In the example illustrated, the first barrier  16  is mounted to the base  12  and is positioned intermediate the medial and lateral portions  26 ,  28  in the lateral direction  22 . The second barrier  18  is mounted to a lateral edge  94  of the lateral portion  28 , and the arm pad  14  is positioned laterally intermediate the first and second barriers  16 ,  18 . 
     Referring to  FIGS. 6, 7, 8 and 9 , it can be seen that the upper surface  44  of the central portion  38  is substantially below the upper surface  40  of the proximal portion  34 . In the example illustrated, the upper surface  44  of the central portion  38  is concave in shape to position the hand generally below the arm. The upper surface  42  of the distal portion  36  is shown to be generally planar and horizontal, and can be used by the attending staff as a working surface. 
     Dimensions for the arm pad  14  are shown in  FIGS. 7, 8 and 9  and provided in Table 1. These dimensions are intended to be illustrative but non-limiting. 
     
       
         
           
               
               
               
               
             
               
                   
                 TABLE 1 
               
               
                   
                   
               
               
                   
                 Dimension 
                 Reference 
                 mm 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 Proximal portion length 
                 48 
                 446 
               
               
                   
                 Central portion length 
                 50 
                 277 
               
               
                   
                 Proximal portion drop 
                 52 
                 19 
               
               
                   
                 Central portion drop 
                 54 
                 44 
               
               
                   
                 Panel length 
                 56 
                 619 
               
               
                   
                 Overall length 
                 58 
                 1067 
               
               
                   
                 Overall width 
                 60 
                 133 
               
               
                   
                 Overall height 
                 62 
                 76 
               
               
                   
                 Panel height 
                 64 
                 1 
               
               
                   
                   
               
            
           
         
       
     
     In some examples, the arm pad  14  can be formed of a foam material that is clad with marine grade vinyl. In some examples, the radiopaque panel  46  can be formed of a relatively thin layer of lead, which can be disposed in the arm pad  14  underneath a bottom outer vinyl layer. In some examples, the upper surface  42  of the distal portion  36  can be reinforced to create a stable working surface. 
     Referring to  FIGS. 10, 11 and 12 , the base  12  is shown to be generally planar and arranged horizontally. The base  12  can be formed at least partially of a substantially radiolucent material. In some examples, the base  12  can be formed of a unitary piece of clear polycarbonate material. 
     In the example illustrated, the medial portion  26  of the base  12  includes a central aperture  66  that is positioned so that, in use, it is underneath an abdomen of the human patient. The lateral portion  28  is also shown to include a series of apertures  68 . The apertures  66 ,  68  can be cutouts of the base  12  that reduce weight and decrease impedance during medical imaging. 
     As shown in  FIG. 11 , the first barrier  16  can be mounted to the base  12  by a flexible and resilient connection  70  to permit adjustment of its position. In some examples, the connection  70  can be a curved bracket formed of spring steel, and fastened between the first barrier  16  and the base  12 . 
     Dimensions for the base  12  are shown in  FIG. 12  and provided in Table 2. These dimensions are intended to be illustrative but non-limiting. 
     
       
         
           
               
               
               
               
             
               
                   
                 TABLE 2 
               
               
                   
                   
               
               
                   
                 Dimension 
                 Reference 
                 mm 
               
               
                   
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 Base length 
                 72 
                 1143 
               
               
                   
                 Base width 
                 74 
                 635 
               
               
                   
                   
               
            
           
         
       
     
     It can be seen in  FIG. 12  that each of the aperture  66 , the first barrier  16  and the second barrier  18  can be aligned with a transverse axis  76 . 
     Referring to  FIGS. 13 and 14 , the first and second barriers  16 ,  18  are each shown to be generally planar and arranged vertically. The first and second barriers  16 ,  18  can each be formed at least partially of a substantially radiopaque material. In some examples, the first and second barriers  16 ,  18  can be formed of vinyl coated lead sheets. 
     In the example illustrated, the second barrier  18  includes first and second planar portions  78 ,  80 . The planar portions  78 ,  80  have outward vertical edges  82 ,  84 . In the example illustrated, the second planar portion  80  is joined to the first planar portion  78  at an oblique angle, so that the vertical edge  84  is spaced apart laterally from the vertical edge  82  in a direction away from the rest of the apparatus  10 , which provides some clearance for a patient table. 
     Referring to  FIG. 15 , the apparatus  10  is shown supporting an arm  86  of a human patient  88 . The human patient  88  is shown lying on a mattress  90  and a table  92 . 
     In the example illustrated, the medial portion of the base lies between the human patient  88  and the table  92 . It will be appreciated that, in other examples, the medial portion of the base can be omitted, and an alternative means of attaching the apparatus to the side of the table can be used. 
     There can be several advantages to the apparatus of the present disclosure over products currently on the market. These advantages relate to: increased radiation protection, improved visualization, greater operator convenience, and enhanced patient comfort. 
     In terms of increased radiation protection, the radiation barriers and panel can be substantially radiopaque, and can block significantly more radiation than existing shielding equipment. The apparatus can also be compatible with femoral access procedures, and provide radiation protection for such cases. 
     In terms of improved visualization, the polycarbonate base can be more radiolucent than existing devices, which can reduce the amount of radiation needed during medical imaging. Furthermore, the position of the base under the patient&#39;s abdomen is also outside of the typical field of view (the patient&#39;s chest), which can prevent both increases in radiation and image degradation. Moreover, the positioning of the radiation barriers and panel can allow clear fluoroscopic visualization of the patient&#39;s arm. 
     In terms of operator convenience, beyond the patient&#39;s hand, the working surface of the distal portion of the arm pad can be level with the patient&#39;s wrist and provide a convenient platform upon which the attending staff can manipulate equipment. Furthermore, the contoured shapes of the upper surfaces of the proximal and central portions of the arm pad can position the patient&#39;s wrist at a desirable angle, improving the attending staff&#39;s access to the patient&#39;s artery. Moreover, because the apparatus can be compatible with both radial and femoral access cases, the apparatus does not need to be removed between cases depending on the access site chosen. 
     Finally, the arm pad can be relatively large and include contoured foam padding to provide full arm support and enhance patient comfort. Furthermore, the flexibility of the first barrier allows for multiple positions to accommodate the patient, and because it is not rigidly attached it can deflect if it is knocked by the patient or the attending staff. 
     Referring to  FIGS. 16 and 17 , another example of an apparatus for supporting an arm of a human patient during a medical procedure is shown generally at reference number  110 . The apparatus  110  is shown to include a first barrier  116  and a second barrier  118 . In use, the primary arm pad (omitted for clarity of illustration) supports the right arm of the human patient, and the first and second barriers  116 ,  118  can shield an attending staff member from scatter radiation during the medical procedure. 
     In the example illustrated, the apparatus  110  includes a base that includes a medial portion  126  and a lateral portion  128 . The medial portion  126  is configured to lie between the human patient and a table on which the human patient is supported. The lateral portion  128  extends in a lateral direction  122  from the medial portion  126 . To aid with understanding, a longitudinal direction  120 , the lateral direction  122 , and a vertical direction  124  are shown in  FIG. 16 . 
     In the example illustrated, the first and second barriers  116 ,  118  are each mounted to the lateral portion  128  and are spaced from one another in the lateral direction  122 . The first barrier  116  extends upwardly in the vertical direction  124 , and the second barrier  118  extends downwardly in the vertical direction  124 . 
     In the example illustrated, the apparatus  110  includes an additional support surface that is shown generally at reference numeral  200 , which can be referred to as the “left wing”. The left wing  200  is shown coupled to the medial portion  126  opposite from the lateral portion  128 , and extends in the lateral direction  122  away from the medial portion  126 . In use, the left wing  200  can support the left arm of the human patient. 
     Referring to  FIG. 18 , the lateral portion  128  extends laterally to support a width of the primary arm pad (not shown). In the example illustrated, the first barrier  116  is mounted adjacent to a first lateral edge of the lateral portion  128 , and the second barrier  118  is mounted to a second lateral edge of the lateral portion  128 . 
     In the example illustrated, the medial and lateral portions  126 ,  128  of the base are separate components that are capable of disassembly. The medial portion  126  is arranged laterally intermediate the lateral portion  128  and the left wing  200 . 
     Referring to  FIG. 19 , the left wing  200  is shown to include an adjustable support  202  that is coupled to a mounting bracket  204  by hinge mechanisms  206 ,  208 . The support  202  is shown to be generally planar and includes a plurality of cutouts. In the example illustrated, the support  202  includes a central cutout, intended to reduce weight, and four peripheral cutouts, which are designed to accept straps to secure a secondary arm pad (not shown) to the support  202 . In the example illustrated, the support  202  has a relatively large upper portion, and a relatively narrow lower portion adjacent to the hinge mechanisms  206 ,  208 , and is therefore shaped to be less intrusive when pivoted upwardly towards the patient. 
     Referring to  FIG. 20 , the support  202  can be pivoted about a longitudinal axis  210  by actuating a tab  212 . The tab  212  disengages locks in the hinge mechanisms  206 ,  208  to permit pivoting of the support  202  about the axis  210 . Releasing the tab  212  reengages the locks to fix the support  202  at a desired angle. In the example illustrated, the tab  212  is provided at the hinge mechanism  208 , and coordination between the hinge mechanisms  206 ,  208  can be achieved via a shaft  214 . This can allow for one handed adjustment of the left wing  200 . 
       FIG. 21  shows disassembly of the lateral portion  128  and the left wing  200  from the medial portion  126 . In the example illustrated, the lateral portion  128  and the left wing  200  each includes pins that are arranged to engage keyhole slots in the medial portion  126 , permitting quick and easy assembly/disassembly. 
     In the example illustrated, the primary arm pad  14  can rest on the lateral portion  128 , and the secondary arm pad  216  is fixed to the left wing  200  by straps. Two straps are also shown attached to the medial portion  126 , for securing the medial portion  126  to a mattress (not shown) 
     Referring to  FIGS. 22 and 23 , the apparatus  110  is shown supporting arms  186 ,  196  of a human patient  188  lying on a mattress  190  and a table  192 . 
       FIG. 22  shows the arm pad  216  and the left wing  200  in a generally horizontal position. In use, the arm pad  216  can support the left arm  196  of the human patient  188  during a medical procedure, in which the left radial artery of the human patient  188  can be accessed, for example. During the medical procedure, the attending staff member can remain along the right hand side relative to the human patient  188 , and the apparatus  110  can therefore continue to shield the attending staff member from scatter radiation. 
       FIG. 23  shows the left wing  200  in an upright position in which there is an acute angle between the support  202  and the medial portion  126 . This can be a more comfortable position for the human patient  188  to maintain, after the left radial artery has been accessed, and during which images can be taken using a C-arm camera, for example. 
     It will be appreciated that the subject matter of interest herein is not necessarily limited to implementation in cardiac catheterization labs, and can apply more broadly to other medical procedures. 
     Furthermore, it will be appreciated that terms used herein to convey geometrical or mathematical relationships need not be construed with absolute precision. For example, the terms ‘concave’ and ‘convex’ as used herein need not be interpreted to mean structures having a curved surface that is exactly circular. These terms and other terms herein may be interpreted with some flexibility, without strict adherence to mathematical definitions, as will be appreciated by persons skilled in the art. It will also be appreciated that terms used herein to connote orientation, including ‘up’, ‘down’, ‘above’, ‘below’, ‘lateral’, ‘longitudinal’, ‘vertical’ and ‘horizontal’, correspond to the arm board apparatus in use and are intended to aid with understanding, but need not refer to the orientation of various components during manufacture or when not in use. 
     While the above description provides examples of one or more apparatuses or methods, it will be appreciated that other apparatuses or methods may be within the scope of the accompanying claims.