Abstract:
A radial check device and methods are provided for accessing ulnar and/or radial flow and producing documentation of such assessment.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a continuation-in-part application of PCT/US 14/36777, filed under the authority of the Patent Cooperation Treaty on May 5, 2014; published; which claims priority to U.S. Provisional Application No. 61/819,747, filed under 35 U.S.C. §111(b) on May 6, 2013. This application also claims priority to U.S. Provisional Application No. 62/064,503, filed under 35 U.S.C. §111(b) on Oct. 16, 2014. The entire disclosures of all the aforementioned applications are incorporated herein by reference for all purposes. 
     
    
     TECHNICAL FIELD 
       [0002]    The invention relates generally to medical devices. More specifically, the invention is a radial check device. 
       BACKGROUND OF THE INVENTION 
       [0003]    Radial artery access is being increasingly used by physicians for diagnostic and coronary procedures. In preparation for such procedures, the Allen&#39;s test (or modified plethysmography) has been used to determine the patency of the radial and ulnar arteries. This is a manual test in which a healthcare professional, usually a nurse, places his or her thumbs over the radial arteries of a patient while the patient is clenching his or her fists. This compresses the radial arteries. The patient is then asked to open his or her hands into a relaxed position. The healthcare professional then observes the color of the palms, which should normally turn pink promptly. An abnormal test occurs when the color of the palm does not return within eight seconds. This procedure is then repeated by occluding the ulnar arteries. In another form of this test, the fingers of the healthcare professional are used to occlude both the radial and ulnar arteries of the patient. Pressure on the ulnar artery is then removed while maintaining pressure on the radial site. The color of the palm is then observed. This procedure is then performed on the other arm. 
         [0004]    In those patients that require a second procedure through the same radial site, it is often useful to perform a reverse Allen&#39;s test. In this procedure, the healthcare professional releases pressure over the radial artery rather than the ulnar artery. This may detect proximal radial artery disease/occlusion that may be asymptomatic. 
         [0005]    Barbeau&#39;s test is another preparation procedure. This test includes the steps as follows: placing a pulse oximeter (plethysmography) on an index finger or a thumb to demonstrate a normal waveform/tracing and releasing pressure over the ulnar artery and watching the pulse oximetry tracing. The immediate return of normal waveform suggests a normal (positive) test, which is indicative of good ulnar flow and a lower risk of hand ischemia with radial catheterization. If the waveform does not immediately return, one can wait two minutes to evaluate the waveform. If the waveform returns within two minutes, then one can still consider radial catheterization. 
         [0000]    
       
         
               
             
           
               
                   
               
             
             
               
                 
                   
                             
                     
                         
                         
                     
                   
                 
               
               
                   
               
             
          
         
       
     
         [0006]    It has been found that these tests are deficient for a variety of reasons. For example, they are done in a subjective fashion in which the healthcare professional uses his or her observation of palm color to determine the patency of the arteries. Further, they require extensive expertise and training on the part of the healthcare professional performing the tests. Finally, they do not provide a permanent record of the tests for future use. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    The invention provides a medical device that overcomes the deficiencies of the current manual tests as described above. In this regard, the radial check device according to the invention establishes a new standard of pre-procedural care for patients undergoing any type of radial artery canalization. Further, the invention provides a relatively simple automated test that generates documentation of ulnar and radial flow. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is a perspective view of an embodiment of the radial check device according to the invention positioned on a patient; 
           [0009]      FIG. 2  is a perspective view of an embodiment of the cuff according to the invention; 
           [0010]      FIG. 3  is a perspective view of an alternative embodiment of the radial check device according to the invention positioned on a patient; 
           [0011]      FIG. 4  is an exploded view of the radial check device shown in  FIG. 3 ; 
           [0012]      FIG. 5  is an exploded view of the radial check device shown in  FIG. 3 ; 
           [0013]      FIG. 6  is an exploded view of the radial check device shown in  FIG. 3 ; 
           [0014]      FIG. 7  is a schematic view of an embodiment of the control system for the radial check device shown in  FIG. 3 ; 
           [0015]      FIG. 8A  is a schematic view of an embodiment of the control system for the radial check device shown in  FIG. 3 ; 
           [0016]      FIG. 8B  is a schematic view of an embodiment of the control system for the radial check device shown in  FIG. 3 ; 
           [0017]      FIG. 9  is a perspective view of an alternative embodiment of the radial check device according to the invention positioned on a patient; 
           [0018]      FIG. 10  is a detailed perspective view of the occlusion cuff and the first and second inflatable portions of the radial check device shown in  FIG. 9 ; and 
           [0019]      FIG. 11  is a cross-sectional view taken along line  11 - 11  of  FIG. 10 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0020]    The invention will now be described in detail with reference being made to the drawings. In the drawings, an embodiment of the radial check device according to the invention is indicated generally by the reference number “ 10 .” Referring to  FIG. 1 , the radial check device  10  has an occlusion cuff  12  configured for positioning on a patient&#39;s arm and a pulse oximeter  14  configured for positioning on a patient&#39;s finger, such as an index finger, or thumb. 
         [0021]    As shown in  FIGS. 1 and 2 , the occlusion cuff  12  has an interior surface  16  and an exterior surface  18 . A first fastener  20  is positioned on the interior surface  16  and a second fastener  22  is positioned on the exterior surface  18 . For example, the first and second fasteners  20  and  22  can be hook and loop-type fasteners that adhere to each other when pressed together. The engagement of the first and second fasteners  20  and  22  position the occlusion cuff  12  on a patient&#39;s arm. 
         [0022]    Still referring to  FIGS. 1 and 2 , the interior surface  16  of the occlusion cuff  12  includes a first inflatable portion  24  and a second inflatable portion  26 . The first and second inflatable portions  24  and  26  are configured to expand and contract in order to occlude or release one or both of the radial and ulnar arteries when the occlusion cuff  12  is positioned on a patient&#39;s arm as shown in  FIG. 1 . 
         [0023]    As shown in  FIG. 1 , the occlusion cuff  12  has a control member  28  positioned on the exterior surface  18 . In an embodiment, the control member  28  includes an energy source such as a battery to actuate the first and second inflatable portions  24  and  26 , a cuff display screen  30  powered by the battery, and a cuff on/off button  32 . The control member  28  includes hardware, software and/or firmware configured to control the operation of the radial check device  10 . 
         [0024]    Still referring to  FIG. 1 , the pulse oximeter  14  includes first and second finger members  34  and  36  that are connected by a hinge or other device to allow for clamping on a patient&#39;s finger. In an embodiment, the pulse oximeter  14  includes an energy source such as a battery, a pulse oximeter display screen  38  powered by the battery, and a pulse oximeter on/off button  40 . The pulse oximeter  14  includes hardware, software and/or firmware configured to control the operation of the radial check device  10 . 
         [0025]    As shown in  FIG. 1 , the pulse oximeter  14  is operatively connected to the control member  28  as indicated by the line  42 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the pulse oximeter  14  and the control member  28 . 
         [0026]    Still referring to  FIG. 1 , the radial check device  10  includes a recording device  44  that is operatively connected to the control member  28  as indicated by the line  46 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the control member  28  and the recording device  44 . The recording device  44  is used to produce a record of the data being generated by the radial check device  10 . For example, the recording device  44  can be a printing device that produces a paper record of the data. In another example, the recording device  44  can be an electronic device such as a computer that produces an electronic record of the data. In another example, the recording device  44  is integral with the control member  28 . The record can then be entered in a patient&#39;s paper and/or electronic chart to document a test. 
         [0027]    In use, the radial check device  10  is positioned on a patient as shown in  FIG. 1 . In an embodiment, the first and second inflatable portions  24  and  26  are inflated to occlude the radial and ulnar arteries, respectively. The pulse oximeter  14  provides an automated oximetry tracing to the control member  28 . In an embodiment, such tracing is shown on the cuff display screen  30 . The second inflatable portion  26  is then released and the oximetry tracing is transmitted to the recording device  44 . The record produced by the recording device  44  is then entered in the patient&#39;s chart. In an embodiment, the radial check device  10  can perform a reverse Barbeau test to check for radial flow for patients with repeat radial procedures. 
         [0028]    Referring to  FIGS. 3-8B , an alternative embodiment radial check device  50  is shown and described. As shown in  FIG. 3 , the radial check device  50  has an occlusion cuff  52  configured for positioning on a patient&#39;s arm and a pulse oximeter  54  configured for positioning on a patient&#39;s finger, such as an index finger, or thumb. The occlusion cuff  52  has a bottom housing  56 , a top housing  58 , a first end  60 , a second end  62 , a first side  64  and a second side  66 . A first strap  68  is positioned adjacent to the first end  60  and a second strap  70  is positioned adjacent to the second end  62 . For example, the first and second straps  68  and  70  can include hook and loop-type fasteners that adhere to each other when pressed together. The first and second straps  68  and  70  position the occlusion cuff  52  on a patient&#39;s arm. The pulse oximeter  54  can be of the type described above with respect to pulse oximeter  14 . In an embodiment, the pulse oximeter can be of a conventional type. 
         [0029]    Referring to  FIGS. 3-6 , the occlusion cuff  52  includes a first actuator  72  having a first actuator tip  74  and a second actuator  76  having a second actuator tip  78 . For example, as shown in this embodiment, the first and second actuators  72  and  76  can be pneumatic cylinder actuators. However, it should be understood that the first and second actuators  72  and  76  can be any suitable type of actuator that can move the first and second actuator tips  74  and  78 . 
         [0030]    As shown in  FIGS. 4-6 , the first and second actuators  72  and  76  are movably mounted in the bottom housing  56  of the occlusion cuff  52 . In this regard, the first and second actuators  72  and  76  are mounted on an actuator plate  80  that is pivotally positioned on a mounting frame  82  by first and second shafts  84  and  86 . The actuator plate  80  includes a rod  88  that includes first and second rod ends  90  and  92  for mounting first and second knobs  94  and  96 , which are positioned on the first and second sides  64  and  66 , respectively, of the occlusion cuff  52 . The turning of the first and second knobs  94  and  96  causes the first and second actuators  72  and  76  to be moved in order to adjust the first and second actuator tips  74  and  78  with respect to the patient&#39;s arm. As shown in  FIG. 6 , the first and second actuator tips  74  and  78  are positioned on first and second tip housings  98  and  100 , respectively. As shown in  FIG. 6 , the first actuator  72  is in communication with first actuator tubes  102  and  104 , and the second actuator  76  is in communication with second actuator tubes  106  and  108 . 
         [0031]    Referring to  FIGS. 3 ,  7 ,  8 A and  8 B, the radial check device  50  has a control system  110 . As shown and described in the drawings, the control system  110  generally includes a power supply  112 , a controller  114 , a controller interface  116 , and an actuator control system  118 . The control system  110  includes hardware, software and/or firmware configured to control the operation of the radial check device  50 . 
         [0032]    As shown in  FIGS. 6 ,  7 ,  8 A and  8 B, the actuator control system  118  includes a pump  120  in communication with first, second, third and fourth valves  122 ,  124 ,  126  and  128  that are in communication with the first and second actuator tubes  102 ,  104 ,  106  and  108 . The actuation of the pump  120  controls the actuation of the first and second actuators  72  and  76 . It should be understood that any suitable control system  110  can be used to control the actuation of the first and second actuators  72  and  76 . 
         [0033]    Referring to  FIG. 3 , the radial check device  50  can include a recording device  130  that is operatively connected to the control system  110  as indicated by the line  132 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the control system  110  and the recording device  130 . The recording device  130  is used to produce a record of the data being generated by the radial check device  50 . For example, the recording device  130  can be a printing device that produces a paper record of the data. In another example, the recording device  130  can be an electronic device such as a computer that produces an electronic record of the data. In another example, the recording device  130  is integral with the control system  110 . Further, the pulse oximeter  54  can be operatively connected to the control system  110 , as indicated by the line  134 , for recording data. The recorded data can then be entered in a patient&#39;s paper and/or electronic chart. As shown in  FIG. 3 , the occlusion cuff  52  can include a cuff display screen  136  to allow for the viewing of, for example, generated data and user interface symbols. 
         [0034]    In use, the radial check device  50  is positioned on a patient as shown in  FIG. 3 . In this regard, the first and second actuators  72  and  76  are positioned over, for example, the radial and ulnar arteries of the patient. The positioning of the first and second actuators  72  and  76  can be adjusted by turning the first and second knobs  94  and  96 . Once the radial check device  50  is in position, first and second actuators  72  and  76  are actuated or inflated by the control system  110  to cause the first and second actuator tips  74  and  78 , respectively, to occlude the radial and ulnar arteries. The pulse oximeter  54  provides an oximetry tracing. The second actuator  76  is then released and the pulse oximeter  54  provides another oximetry tracing. The oximetry tracings are read by the healthcare professional performing the test. In an embodiment, the oximetry tracings are shown on the cuff display screen  136 . In an embodiment, the oximetry tracings are transmitted to the recording device  130 . In an embodiment, the record produced by the recording device  130  is entered in the patient&#39;s chart. In an embodiment, the radial check device  50  can perform a reverse Barbeau test to check for radial flow for patients with repeat radial procedures. 
         [0035]    Referring to  FIGS. 9-11 , an alternative embodiment radial check device  150  is shown and described. As shown in  FIG. 9 , the radial check device  150  has an occlusion cuff  152  configured for positioning on a patient&#39;s arm and a pulse oximeter  154  configured for positioning on a patient&#39;s finger, such as an index finger, or thumb. 
         [0036]    As shown in  FIGS. 9 and 10 , the occlusion cuff  152  has an interior surface  156  and an exterior surface  158 . A first fastener  160  is positioned on the interior surface  156  and a second fastener  162  is positioned on the exterior surface  158 . For example, the first and second fasteners  160  and  162  can be hook and loop-type fasteners that adhere to each other when pressed together. The engagement of the first and second fasteners  160  and  162  position the occlusion cuff  152  on a patient&#39;s arm. 
         [0037]    Referring to  FIGS. 9-11 , the interior surface  156  of the occlusion cuff  152  includes a first inflatable portion  164  and a second inflatable portion  166 . The first and second inflatable portions  164  and  166  are configured to expand and contract in order to occlude or release one or both of the radial and ulnar arteries when the occlusion cuff  152  is positioned on a patient&#39;s arm as shown in  FIG. 9 . In an embodiment, the first and second inflatable portions  164  and  166  are adjustable with respect to the occlusion cuff  152  to allow such inflatable portions to be properly positioned with respect to the radial and ulnar arteries. For example, the first inflatable portion  164  can include a first portion mounting member  168  and the second inflatable portion  166  can include a second portion mounting member  170  in which such mounting members are sized and adapted for sliding engagement in a slot  172  of a mounting bracket  174  that is positioned on the interior surface  156  of the occlusion cuff  152  as shown in  FIGS. 10 and 11 . In addition to this example, it should be understood that the first and second inflatable portions  164  and  166  can be adjustably positioned with respect to the occlusion cuff  152  in a variety of ways. In an embodiment, the occlusion cuff  152  and the first and second inflatable portions  164  and  166  are constructed of plastic. In an embodiment, the occlusion cuff  152  and the first and second inflatable portions  164  and  166  are disposable after use. 
         [0038]    As shown in  FIG. 9 , the radial check device  150  has a control member  176  that is separate from the occlusion cuff  152 . In an embodiment, the control member  176  is operatively connected to the first and second inflatable portions  164  and  166  by first and second lines or tubes  178  and  180 . In an embodiment, the control member  176  includes an energy source such as a battery  182  to actuate the first and second inflatable portions  164  and  166 , a cuff display screen  184  powered by the battery  182 , and a cuff on/off button  186 . In an embodiment, the control member  176  includes an actuation device such as a pump system  188  to provide a fluid such as air through the first and second tubes  178  and  180  to inflate or deflate the first and second inflatable portions  164  and  166 . In an embodiment, each of the first and second inflatable portions  164  and  166  includes an expandable and contractible bladder  190  that is in fluid communication with the first and second tubes  178  and  180  and thus the pump system  188  as shown in  FIGS. 9 and 11 . The control member  176  includes hardware, software and/or firmware configured to control the operation of the radial check device  150 . 
         [0039]    Referring to  FIG. 9 , the pulse oximeter  154  includes first and second finger members  192  and  194  that are connected by a hinge or other device to allow for clamping on a patient&#39;s finger. In an embodiment, the pulse oximeter  154  includes an energy source such as a battery  196 , a pulse oximeter display screen  198  powered by the battery  196 , and a pulse oximeter on/off button  200 . The pulse oximeter  154  includes hardware, software and/or firmware configured to control the operation of the radial check device  150 . 
         [0040]    As shown in  FIG. 9 , the pulse oximeter  154  is operatively connected to the control member  176  as indicated by the line  202 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the pulse oximeter  154  and the control member  176 . 
         [0041]    Still referring to  FIG. 9 , the radial check device  150  includes a recording device  204  that is operatively connected to the control member  176  as indicated by the line  206 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the control member  176  and the recording device  204 . The recording device  204  is used to produce a record of the data being generated by the radial check device  150 . For example, the recording device  204  can be a printing device that produces a paper record of the data. In another embodiment, the recording device  204  can be an electronic device such as a computer that produces an electronic record of the data. In another example, the recording device  204  is integral with the control member  176 . The record can then be entered in a patient&#39;s paper and/or electronic chart to document the test. 
         [0042]    In use, the radial check device  150  is positioned on a patient as shown in  FIG. 9 . In an embodiment, the first and second inflatable portions  164  and  166  are inflated to occlude the radial and ulnar arteries, respectively. The pulse oximeter  154  provides an automated oximetry tracing to the control member  176 . In an embodiment, such tracing is shown on the cuff display screen  184 . The second inflatable portion  166  is then released and the oximetry tracing is transmitted to the recording device  204 . The record produced by the recording device  204  is then entered in the patient&#39;s chart. In an embodiment, the radial check device  150  can perform a reverse Barbeau test to check for radial flow for patients with repeat radial procedures. 
         [0043]    By way of non-limiting examples, the radial check device  10 ,  50 , or  150  can be used in all places of a hospital or other healthcare facility (e.g., cardiac catheterization lab, vascular interventions lab, pediatric and/or adult intensive care unit, pre-operative anesthesia unit) in which the radial artery of a patient is used for cannulation. The invention provides a relatively simple medical device that a healthcare professional can utilize to access the ulnar and/or radial flow of a patient, and then place the documentation generated by the device in the paper and/or electronic chart of the patient. As it will be appreciated by those skilled in the art, the invention establishes a new standard of pre-procedural care for patients undergoing any type of radial artery canalization. 
         [0044]    Certain embodiments of the apparatus disclosed herein are defined in various examples. It should be understood that these examples, while indicating particular embodiments of the invention, are given by way of illustration only. From the above discussion and these examples, one skilled in the art can ascertain the essential characteristics of this disclosure, and without departing from the spirit and scope thereof, can make various changes and modifications to adapt the compositions and methods described herein to various usages and conditions. Various changes may be made and equivalents may be substituted for elements thereof without departing from the essential scope of the disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the disclosure without departing from the essential scope thereof.