Abstract:
A fluid analysis simulation and training system and method. An embodiment includes an educational monitor that allows desired data and results to be displayed on a simulated glucometer as part of a faculty computer. In this embodiment, a faculty member controls the data displayed depending on the action of the learners. The present invention also discloses a model allowing the opportunity to practice the skill of obtaining a blood sample in a simulated environment. The model includes a simulated finger configured for placement over a manikin or simulated patient&#39;s finger and for holding a simulated patient fluid. In an exemplary embodiment, the simulated patient fluid includes a predetermined amount of glucose and is configured for testing with a standard glucometer. In another embodiment, the simulated patient fluid is inert, and a faculty member, or instructor, controls the display on a simulated glucometer.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority in U.S. Provisional Patent Application Ser. No. 62/066,284, filed Oct. 20, 2014, which is incorporated herein by reference. This application also incorporates by reference U.S. patent application Ser. No. 14/607,013, filed Jan. 27, 2015; U.S. patent application Ser. No. 14/594,126, filed Jan. 10, 2015; U.S. patent application Ser. No. 14/165,485, filed Jan. 27, 2014; U.S. patent application Ser. No. 13/597,187, filed Aug. 28, 2012; and U.S. patent application Ser. No. 11/751,407, filed May 21, 2007, now U.S. Pat. No. 8,251,703, issued Aug. 28, 2012. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates generally to a design of a finger model and a monitor that portrays a realistic blood glucose procedure to enhance bedside monitoring capability. 
         [0004]    2. Description of the Related Art 
         [0005]    Simulation is an immersive learning experience that depends on a realistic environment to engage the learner. In simulation scenarios, particularly medical treatment simulations, it is important for data to be assessed and displayed realistically to maintain learner engagement within the simulated environment. Monitoring blood glucose is a common bedside procedure performed in the treatment of many different medical conditions. 
         [0006]    Blood sugar concentration or blood glucose level is the amount of glucose (sugar) present in the blood, which is normally tightly regulated as part of metabolic homeostasis. Many medical conditions require monitoring blood glucose. Changing blood glucose levels is inherently a primary concern or potential complication of many different illnesses or health alterations. 
         [0007]    For example, monitoring blood glucose is extremely important for the health of patients with diabetes. Hyperglycemia, or high blood glucose, is a common indicator of a diabetic medical condition. Long-term hyperglycemia can cause health problems associated with diabetes, including heart disease, eye damage, kidney damage, and nerve damage. Diabetes directly affects about 10% of all adults, and diabetes was reported as the primary diagnosis for approximately 30 million visits last year to various healthcare facilities. Diabetes is reported as one of the seven major contributing factors for heart disease and cardiac arrest by the American Heart Association. In fact, about two thirds of patients with diabetes die of heart disease or stroke. 
         [0008]    Conversely, hypoglycemia, or low blood glucose, is a potentially fatal medical condition which can be associated with lethargy, impaired mental function, muscular weakness, and brain damage. Patients with such medical conditions are commonly carefully monitored at frequent intervals to avoid serious medical complications. Emergency or “code blue” scenarios and stroke protocols need to establish blood glucose for differential diagnosis and management of patient symptoms. Thus, a realistic simulation of testing blood glucose levels would be extremely beneficial for training medical professionals as well as diabetes patients. 
         [0009]    Currently, there are no monitors or devices available to adequately simulate a finger stick for obtaining a blood sample capable of use with simulators, manikins, or standardized patients. Typically, a finger stick would puncture a manikin finger or a real finger of a standardized patient. Additionally, there are no models or devices available to simulate different blood glucose levels of a patient that can be used with a real glucometer or simulated glucometer. 
       SUMMARY OF THE INVENTION 
       [0010]    The present invention discloses an educational monitor that allows desired data and results to be displayed on a simulated glucometer as part of a faculty computer. In this embodiment, a faculty member controls the data displayed depending, at least in part, on the action of the learners. 
         [0011]    The present invention also discloses a model allowing the opportunity to practice the skill of obtaining a blood sample in a simulated environment. The model includes a simulated finger configured for placement over a manikin or simulated patient&#39;s finger and for holding a simulated patient fluid. In one exemplary embodiment, the simulated patient fluid includes a predetermined amount of glucose and is configured for testing with a standard glucometer. In another embodiment, the simulated patient fluid is inert, and a faculty member, or instructor, controls the display on a simulated glucometer. The present invention can be used with all types of simulation, including but not limited to simulators, manikins, and standardized patients. 
         [0012]    The invention creates a low cost, realistic set-up to simulate obtaining blood glucose levels using the skill of accessing blood and includes the option to control results with a monitor device. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  is a block diagram of a glucometer training system embodying a first aspect of the present invention. 
           [0014]      FIG. 2  shows instructor controls and display on an instructor computing device for a glucometer training system. 
           [0015]      FIG. 3  is a schematic diagram of a glucometer simulation and training system embodying the first aspect of the present invention. 
           [0016]      FIG. 4  shows a typical prior art glucometer, which can be used in connection with a second aspect of the present invention. 
           [0017]      FIG. 5  shows a top, plan view of a finger and a blood serum interface having a protective shield mounting a bleb. 
           [0018]      FIG. 6  shows side, elevational view of the finger and blood serum interface having a protective shield mounting a bleb. 
           [0019]      FIG. 7  shows a top, plan view of a finger and a blood serum interface having a puncture-resistant pad mounting a bleb. 
           [0020]      FIG. 8  shows a top, perspective view of the finger and blood serum interface having a puncture-resistant pad mounting a bleb. 
           [0021]      FIG. 9  shows a side, elevational view of the finger and blood serum interface having a puncture-resistant pad mounting a bleb. 
           [0022]      FIG. 10  shows side, elevational, exploded view of a blood serum interface including a bleb, a puncture-resistant pad, and a simulated fingertip. 
           [0023]      FIG. 11  shows a side, elevational view of filling the bleb of the blood serum interface with simulated blood serum from a syringe. 
           [0024]      FIG. 12  shows a side, elevational, exploded view of the blood serum interface and a finger. 
           [0025]      FIG. 13  shows a side, elevational view of a finger and the blood serum interface including a bleb, a puncture-resistant pad, and a simulated fingertip. 
           [0026]      FIG. 14  shows a top, perspective view of an embodiment of a blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir for glucometer training 
           [0027]      FIG. 15  is a side, elevational view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir. 
           [0028]      FIG. 16  is a front, elevational view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir. 
           [0029]      FIG. 17  is a back, elevational view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir. 
           [0030]      FIG. 18  is a top, plan view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir. 
           [0031]      FIG. 19  is a bottom, plan view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir. 
           [0032]      FIG. 20  is an XY-plane cross-sectional, top, perspective view of the back portion of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir. 
           [0033]      FIG. 21  is an XZ-plane cross-sectional, top, perspective view of the bottom portion of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir. 
           [0034]      FIG. 22  is a YZ-plane cross-sectional, top, perspective view of one side of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir. 
           [0035]      FIG. 23  shows a perspective view of a protective shield for placement over a finger and under the blood serum interface. 
           [0036]      FIGS. 24-30  show another embodiment of a blood serum interface including a finger splint mounting two fluid-holding blebs and a common fillable reservoir for glucometer training 
           [0037]      FIGS. 31-35  show an alternative embodiment of a blood serum interface including a finger splint mounting one fluid-holding bleb and a fillable reservoir for glucometer training 
           [0038]      FIGS. 36-38  show another alternative embodiment of a blood serum interface including a finger splint which mounts two fluid-holding blebs and has perforations for filling the blebs from inside the finger splint. 
           [0039]      FIG. 39  shows an embodiment of a blood serum interface including a finger splint which mounts a fluid-holding bleb and has perforations for filling the bleb from inside the finger splint. 
           [0040]      FIGS. 40-43  show another embodiment of a blood serum interface including a thimble and a finger cot configured for holding simulated blood serum in the intermediate space between the thimble and the finger cot. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     I. Introduction and Environment 
       [0041]    As required, detailed aspects of the present invention are disclosed herein, however, it is to be understood that the disclosed aspects are merely exemplary of the invention, which may be embodied in various forms. 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 how to variously employ the present invention in virtually any appropriately detailed structure. 
         [0042]    Certain terminology will be used in the following description for convenience in reference only and will not be limiting. For example, up, down, front, back, right and left refer to the invention as orientated in the view being referred to. The words, “inwardly” and “outwardly” refer to directions toward and away from, respectively, the geometric center of the aspect being described and designated parts thereof. Forwardly and rearwardly are generally in reference to the direction of travel, if appropriate. Said terminology will include the words specifically mentioned, derivatives thereof and words of similar meaning 
       II. Simulated Glucometer System Controlled by Instructor 
       [0043]    In an exemplary embodiment of the present invention, a simulated glucometer  202  is used for simulation of testing for blood glucose levels. In this embodiment, any simulated blood substance can be used in the blood glucose testing simulation. Preferably, the simulated blood substance  214 , or simulated patient fluid, is semi-viscous and red in color to best simulate the appearance of blood, however these features are not required. In this simulation, the simulated patient fluid  214  can be filled into a resealable “bleb”  508  of a simulated fingertip  506  (such as the one previously described in U.S. patent application Ser. No. 14/607,013, which is incorporated by reference). The simulated finger  506  is configured for placement over the actual finger  626  of a simulated patient or volunteer or a manikin finger. The bleb  508  is configured for puncture by a clinical lancet  614  to obtain at least one droplet  616  of simulated patient fluid  214  for simulated blood glucose testing. After puncture, a droplet  616  of simulated blood  214  is led to the end of a simulated test tape  222 , and the test tape  222  is then placed into a simulated glucometer  202 . 
         [0044]    In this embodiment, the simulated glucometer  202  has a display screen configured to display data similar to readings on a real, clinical glucometer. An instructor computing device  114  is connected to the simulated glucometer display, and an instructor uses the instructor computing device  114  to control the display data based at least in part on the actions of the user, or student. The instructor computing device  114  can be a laptop computer, a desktop computer, a mobile device, a tablet, or any other type of computing device. Connection  116  of the instructor computing device  114  to the simulated glucometer display can be a wireless internet connection, a hard-wired internet connection, a Bluetooth connection, a wireless intranet connection, a hard-wired intranet connection, or any other type of remote connection. The blood glucose testing simulation  102  is repeated as desired with the instructor controlling the simulated glucometer readings. 
         [0045]      FIG. 1  shows a block diagram of a simulation system  102  with an instructor computing device  114  having a connection  116  to a simulated glucometer  202  and being configured to control the output on the simulated glucometer display  203 . The instructor computing device  114  includes a vital signs display device (VSDD)  118 , inputs  120 , and memory  122 . 
         [0046]      FIG. 2  shows instructor controls and display  144  for an instructor computing device  114  configured for controlling glucometer simulation. The instructor controls and display  144  include a control section  146  and the VSDD  118 . Controls for power  148 , mode select  150 , display  152 , start  154 , pause  156 , stop  157 , scroll up  149 , and scroll down  151  can be provided as shown. However, the layout of controls shown in  FIG. 2  is merely one embodiment. Alternatively, the control section  146  could have other control buttons and/or a different layout. In this embodiment, the VSDD  118  includes a glucose level section  166  and an alarms section  174 . The glucose level section  166  includes a sliding scale  168  for the instructor to adjust the glucose level readings for the glucometer simulation. The glucose level sliding scale  168 , set by an instructor, controls the output of blood glucose readings on the simulated glucometer display  203 . The alarms section  174  includes a select switch  176 , a silence (mute) switch  178 , a high limit switch  180 , and a low limit switch  182 . The limit switches  180 ,  182  in this embodiment permit entry of values corresponding to high and low blood glucose values which, when exceeded, cause an alarm to be output on the simulated glucometer display  203 . 
         [0047]      FIG. 3  shows an embodiment of a connection  116  between an instructor computing device  114  and a simulated glucometer  202 , the connection  116  being an internet connection. This embodiment includes a system computer  6  connected to an input/output (I/O) interface component  320  configured to interface with input and output (I/O) devices via the internet, or the cloud  322 . The instructor computing device  114  and the simulated glucometer  202  interact with the I/O interface  320 . The instructor computing device  114  can be any computing device capable of connecting to an I/O interface  320 , including but not limited to a laptop computer, a desktop computer, a tablet, or a smart phone. In a preferred embodiment, the internet connection  322  is wireless, however, a hard-wired internet connection could be used. Alternatively, Bluetooth, wireless intranet, or hard-wired intranet connections could be used. The present system can also be adapted for use with other simulated medical devices. 
         [0000]    III. Simulated Patient Fluid for use with Clinical Glucometer 
         [0048]    An embodiment of the present invention allows one to use simulated patient fluid  214  with any existing (real, not simulated) clinical glucometer  252 . For example, the simulated patient fluid  214  can be used with inexpensive glucometer models for home use, such as models available at Walmart for approximately $ 10 . Most standard glucometers  252  require use with brand specific test tapes  222 , or test strips, which will also need to be purchased for the simulation. Any currently available lancet  220  can be used to accomplish a “puncture” to obtain at least one droplet  216  of simulated patient fluid  214  for blood glucose testing. 
         [0049]    This simulation first requires preparation of proprietary glucose/imitation blood preparations, or simulated patient fluid  214 , to be used in conjunction with fingertip simulators. In this embodiment, the simulated blood preparations  214  are prepared with a predetermined amount of glucose. Such simulated blood  214  can come in kits of simple “low” level blood glucose, “normal” level blood glucose, and “high” level blood glucose. The simulated patient fluids  214  are made up of existing available imitation blood solutions combined with protein or vegetable solutions. Generally, test tapes  222  for all types of glucometers  252  do not respond to simple glucose and water solutions with dye because the test tapes  222  have osmotic and oncotic requirements in order to respond to real, human blood. Because of slight variances in osmotic and oncotic requirements of test tapes  222  from brand to brand, specific glucometer brand to solution preparations may be available so that clientele may use any available glucometers  252  to train with. 
         [0050]    Alternatively, the present invention can be used for more complex diabetic care training with a broader range of glucose levels to be imitated. An example larger kit could include the following simulated blood preparations: 40 mg %, 80 mg %, 100 mg %, 125 mg %, 175 mg %, 200 mg %, 250 mg %, 300 mg %, 400 mg %, 500 mg % and 600 mg % blood glucose. This kit would include 11 vials to represent the range of glucose results to be replicated for different medical scenarios. However, the aforementioned example is not limiting. Any set of blood glucose preparations can be customized to simulate any scenarios devised and requisitioned. 
         [0051]    In this embodiment, a solution of simulated blood  214  is drawn up from a vial with a needle and syringe  433  and injected into a resealable “bleb” portion  408  of a simulated fingertip. Such a simulated fingertip is designed to be reused several times, with care, making it cost effective. The simulated finger includes at least one bleb  408  configured to hold simulated blood  214  and includes a fingertip guard configured to protect the rubber finger of a manikin or the actual finger of a standardized patient or volunteer from puncture. The disclosed simulated finger can have different configurations, but one configuration is a splint type solid portion (e.g. a distal IP joint extensor rupture splint with distal phalanx pad solid half shell and dorsal middle phalanx extension for holding the splint in place) which mounts one or more blebs. 
         [0052]    The simulated finger blebs  408  are configured to be punctured with a lancet  220  to simulate obtaining blood from an actual finger for blood glucose testing. After lancet  220  puncture of a bleb  408  of the simulated finger, a droplet  216  of the previously injected glucose simulation fluid  214  is obtained and led to the end of a test tape  222 . The test tape  222  is then inserted into a clinical, or real, glucometer  252 , registering the glucose level of the simulated blood  214  on a display screen  253  of the glucometer. This blood glucose testing simulation is repeated as desired with different simulated blood glucose preparations. 
         [0053]    An embodiment of a glucometer simulation is shown in  FIGS. 5-13 . The glucometer training system  402  includes a blood serum interface  404  which mounts a bleb  408  and is configured for placement over a fingertip  426 . The bleb  408  is configured for being filled with simulated blood serum  214  using a syringe  432 . The interface  404  most commonly includes a thimble or fingertip shield  412  to protect the underlying part of the fingertip  426  from puncture, as shown in  FIGS. 5-6 . In this embodiment, a rubber or latex-like finger cot  406  is configured to fit around the thimble or finger shield  412  and the bleb  408 . Alternatively, as shown in  FIGS. 7-9 , a soft, protective gel or latex pad  422 , rather than a thimble or protective shield, can mount a bleb  408  and be placed on the volar portion  424  of the fingertip  426  to protect the fingertip  426  from puncture. Another embodiment, shown in  FIGS. 10-13 , includes placing a pad  422  and mounted bleb  408  on the volar portion  424  of a simulated fingertip  442  and placing the simulated fingertip  442  over a patient/subject&#39;s fingertip  426 . The bleb  408  is designed to be filled with semi-viscous fluid  214  including a predetermined amount of glucose and protein or vegetable solutions. This allows a student to puncture the bleb  408  with a clinical lancet  220 , obtain a droplet  216  of blood serum  214  on a test tape  222 , and insert the test tape  222  into a clinical glucometer  252 , getting a blood glucose reading. 
         [0054]      FIGS. 14-23  show a preferred embodiment of a glucometer training system  502  having a blood serum interface  504  including a simulated finger  506  configured for placement over a manikin or actual finger  526 . In this embodiment, simulated blood serum  214  can be inserted into a common reservoir  520  of the simulated finger  506  through a fill site  522 . The common reservoir  520  in this embodiment is connected to two blebs  508 , one on the ulnar side and one on the radial side of the simulated finger  506 . After the common reservoir  520  is filled with simulated blood serum  214 , pressure can be applied to the reservoir  520  to fill the blebs  508  with the simulated blood serum  214 . This embodiment of a blood serum interface  504  is configured to look like a real finger to better simulate blood glucose testing, including a nail portion  518  which helps with proper orientation of the blood serum interface  504  on the mannequin or real finger  526 . Once the blebs  508  are filled with simulated blood serum  214  and the interface  504  is placed on a manikin&#39;s or simulated patient&#39;s finger  526 , a student can puncture one of the blebs  508  with a clinical lancet  220  to obtain a droplet  216  of the simulated blood serum  214  as if the student was obtaining a blood droplet from a real patient. The droplet  216  of simulated blood serum  214 , in this embodiment, can then be led onto a clinical testing tape  222 , and the testing tape  222  can be inserted into a clinical glucometer  252 . The simulated blood serum  214 , which includes a predetermined amount of glucose and protein or vegetable solution, will give a reading on the clinical glucometer  252 . After obtaining a blood glucose level, the student can continue the simulation with treatment as appropriate. Preferably, this embodiment of a blood serum interface  504  includes a protective shield  534 , either as a separate piece or molded into the simulated finger  506 , to protect the mannequin or actual finger  526  from lancet puncture. 
         [0055]      FIGS. 24-30  show an alternative embodiment of a blood serum interface  604  configured to be used as part of a glucometer training system  602 . The interface  604  is configured for placement over a manikin&#39;s or simulated patient&#39;s finger  626 . The interface  604  in this embodiment includes a layer of protective material  612 , which may comprise of a modified finger splint  606 , such as a Stax-type DIP splint for extensor tendons. The protective layer  612  may consist of metals, hard plastics, and/or other materials capable of protecting a finger  626  from being cut. In this embodiment, the finger splint  606  is modified to mount a resealable membrane configured to form blebs  608  and a common reservoir  620  and to hold simulated blood serum  214 . The common reservoir  620  is configured to be filled with simulated blood serum  214  through a fill site  622  with a needle and syringe  632 . Once the reservoir  620  is filled with simulated blood serum  214 , pressure can be applied to the reservoir  620 , pushing blood serum  214  into the blebs  608 . The blebs  608  are configured for puncture by a lancet  220  to obtain a droplet  216  of blood serum  214 . The droplet  216  of blood serum  214  can then be tested with a test tape  222  and glucometer  252 . The finger splint  606  also has an open nail portion  618  to help with orientation of the interface  604  on the patient/subject&#39;s finger  626  and to make the simulation more realistic. 
         [0056]    Alternatively, a glucometer training system  652  may include a blood serum interface  654  with only one bleb  658  and a separate filling reservoir  670 , as shown in  FIGS. 31-35 . This interface  654  may only have protective material  662  covering the one side of a simulated patient&#39;s or mannequin&#39;s finger which mounts the single bleb  658 . The interface  654  also includes hard material  662  on the opposite side of the finger from the bleb  658  to provide a cantilever effect. This embodiment could be achieved by attaching a bleb  658  with a fillable reservoir  670  to the bottom of a Stax-type splint  656  and placing the splint  656  on a patient/subject&#39;s finger turned 90 degrees. 
         [0057]      FIGS. 36-39  show alternative embodiments of glucometer training systems  702 ,  802  with blood serum interfaces  704 ,  804  including a bleb  808  or blebs  708  without a separate fillable reservoir. The blood serum interfaces  704 ,  804  include a protective layer  712 ,  812  which may comprise a modified Stax-type finger splint  706 ,  806 . These embodiments include at least one hole or perforation  713 ,  813  in the layer of protective material  712 ,  812 , allowing the bleb  808  or blebs  708  to be filled with simulated blood serum  214  from the inside of the protective layer  712 ,  812 . The hole or holes  713 ,  813  in the protective layer  712 ,  812  are configured to be large enough to allow the needle  834  of a syringe  832  through, but small enough to prevent a lancet  220  from fitting through. The finger splints  706 ,  806  also have open nail portions  718 ,  818 , aiding in proper orientation on a patient/subject&#39;s finger and making the simulation more realistic. 
         [0058]      FIGS. 40-43  show another embodiment of a blood serum interface  204  including a puncture-resistant thimble  208  and a latex or rubber-like finger cot  210 . The finger cot  210 , in this embodiment, is configured to fit around the thimble  208 , hold simulated blood serum  214  within the intermediate space  212  between the finger cot  210  and the thimble  208 , and seal against a patient/subject&#39;s finger  226  at the proximate end  218 . The thimble  208  may be made up of metal, hard plastics, and/or any other material capable of protecting a finger  226  from puncture. Once the finger cot  210  is filled with simulated blood serum  214  and placed over the thimble  208  and the patient/subject&#39;s finger  226 , the finger cot  210  can be punctured with a lancet  220 . After lancet  220  puncture, a droplet  216  of blood serum  214  can be led onto a test tape  222  and tested for glucose levels with a glucometer  252 . 
         [0059]    It is to be understood that the invention can be embodied in various forms, and is not to be limited to the examples discussed above. The range of components and configurations which can be utilized in the practice of the present invention is virtually unlimited.