Abstract:
The invention is a medical program providing general information for self-recognition and treatment of an acute stroke and directions to access emergency services. The instructions and medication are held in a transparent plastic pouch containing two depressions for holding medication. The instructions include identifying signs and symptoms of stroke onset, instructions for taking medication, instructions for requesting an evaluation by emergency medical service personnel and a test for stroke likelihood.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    The invention relates generally to strokes and more particularly to a method and system for providing specific medical information, self-diagnostic tests, prescription medication, and quality assurance for providing pre-need, and response to the onset of a stroke. In addition, the method and system of the invention is adaptable to other medical illnesses benefiting from early pharmaceutical intervention. 2. Prior Art  
           [0003]    Stroke is the third leading cause of death and the leading cause of adult disability in the United states. of the approximately 730,000 strokes that occur every year in the United States, 85% are ischemic strokes. Thrombolysis, the use of medication to dissolve blood clots, is the only proven therapy for acute ischemic stroke (AIS). However, successful thrombolytic therapy for ischemic stroke is extremely time-dependent. As the use of thrombolytic therapy for acute stroke increases, emergency medical service including, air medical teams, increasingly become involved in its timely implementation. To maximize the outcome of these patients, medical personnel must understand the theory and practice of thrombolysis for AIS.  
           [0004]    AIS is usually caused by the occlusion of a cerebral artery by clot. Animal studies have demonstrated that temporary occlusion of a cerebral artery produces varying degrees of deficit based on the occlusion&#39;s length of time. These studies demonstrated that occlusions of less than 2 hours produced little or no deficit, but occlusion lasting more than 6 hours produced severe deficits and had a significant incidence of hemorrhage into the infarction. These studies imply that opening an occluded artery with thrombolysis may allow salvage of compromised but viable neurons in an acute stroke. However, they also imply that outcome depends significantly on time.  
           [0005]    It is desirable to provide a method for the immediate response to stroke onset. especially where the patient cannot receive medical care within a three-hour time window. Although the invention involves the screening of potential users by medical doctors, the related art does not address that process in detail. Rather, related art approaches describe the following: A process of helping patients assess their risk of stroke; determine means to reduce stroke risk; recognize stroke onset, assess stroke condition and evaluate use of medication; and guide patients to appropriate health care facility and request timely therapy. Medical conditions, as persons with heart attacks, and allergic reactions are also potential beneficiaries of this new invention.  
           [0006]    For general background material, the following prior art is provided:  
                                                           6,053,864   04/2000   Clawson           6,010,451   01/2000   Clawson           6,004,266   12/1999   Clawson           5,989,187   11/1999   Clawson           5,857,966   01/1999   Clawson           5,554,031   09/1996   Moir           6,007,459   12/1999   Burgess                      
 
         SUMMARY OF THE INVENTION  
         [0007]    The instant invention relates to methods and systems for responding to the emergency medical condition of stroke. Specifically, this invention relates to the process of providing a medical review, providing instruction on reducing risk factors, instruction on identifying stroke onset, instruction to determine the probability of stroke onset, instruction on individual response protocols, the provision of prescription medication, and instruction to determine when medicinal use is appropriate.  
           [0008]    The provision of immediate medical care following the onset of stroke presents several challenges to the victim and medical care providers. The primary challenge stems from the limited time window in which to minimize the devastating impacts of stroke. In short, the challenges include: the rapid treatment time required to minimize the debilitating impact of stroke; the proximity to the care provider; the time required for help to arrive and the time required for the victim to be transported to an appropriate care facility; the need for rapid identification of stroke symptoms; the need for rapid treatment of stroke; the limited nature of emergency response personnel resources; and the variances in training and education of emergency response personnel. This invention, in its best mode of operation, operates as part of a system for the management, processing, and response and treatment of the acute onset of stroke.  
           [0009]    This invention accomplishes the above objectives by: First, gathering the necessary information from potential stroke victims and determining an eligible user population based on prior medical history, and eliminating those from consideration who present unreasonable risk factors. Second, by providing prescription medication, which may be used if the candidate remains eligible after stroke onset. Third by providing detailed instruction information on reducing lifestyle risks. Fourth by providing instructions on how to recognize stroke symptoms. Fifth, by providing instructions on how to respond when symptoms of stroke are present. Sixth, by providing instructions on how to determine whether the probability of stroke is low or high. Seventh, by providing detailed instructions on how to determine if the use of the prescribed medications is indicated. Eighth, by providing detailed instruction and information to be given to the emergency medical personnel upon arrival at the appropriate medical facility. Ninth, by providing detailed instructions on what diagnostic tests are to be requested and what treatment protocols are to be requested upon arrival at an appropriate medical care facility. When used correctly, this invention can improve stroke outcomes, decreases emergency medical response time, improves appropriate treatment rendered, provides a “zero time” emergency response through guidance provided to the victim. This invention is especially important as there is a direct correlation between delay to treatment and impairment, disability, and death. This invention provides a means for reducing the impairment, disability, and death caused by strokes.  
           [0010]    It is desirable to provide for the recognition of stroke risk, identification of stroke factors, and instruction for the immediate appropriate response to stroke onset in systematic protocols to minimize delay in response time to stroke and maximize positive outcome from stroke, thus eliminating or minimizing the disability and death from stroke.  
           [0011]    Accordingly, it is the primary objective of this invention to provide a system that is designed to improve time to stroke and improve medical outcomes.  
           [0012]    Another object of this invention is to provide appropriate response protocols to the individual and medical provider to improve the quality, efficiency and appropriateness of the medical care delivered to the individual.  
           [0013]    Still another object of this invention is to provide the individual with appropriate medication to minimize the impairment that results from delay to appropriate medical treatment.  
           [0014]    A still further object of the invention is to provide a pouch device in which a patient may keep diagnostic information concerning stroke symptoms and medication for treatment of stroke.  
           [0015]    These and other objects of this invention, which will be clear to those of ordinary skill in the art upon review of this patent specification and claims, are achieved by an invention which facilitates the prompt identification and response to stroke, by the provision of information, instruction, medication and protocols. The method and system of this invention is currently envisioned as a combination of written documentation or literature, flow-charts and medication.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    [0016]FIG. 1 diagrammatically depicts the principal elements of the system described in accordance with this invention.  
         [0017]    [0017]FIG. 2 is a flow chart of the potential symptoms and preferred and appropriate response to potential onset of a stroke.  
         [0018]    [0018]FIG. 3 is a diagrammatic depiction of the test used to determine the likelihood that the symptoms experienced are those of a stroke in accordance with the invention.  
         [0019]    [0019]FIG. 4 is a flow chart depicting the steps taken to determine whether medicinal use is appropriate.  
         [0020]    [0020]FIG. 5 is an isometric view of a pouch in which a patient may keep diagnostic information concerning stroke symptoms and medication for treatment of stroke.  
         [0021]    [0021]FIG. 5 a . is an isometric view of a pouch in which a patient may keep diagnostic information concerning stroke symptoms and medication for treatment of stroke.  
         [0022]    [0022]FIG. 6 is a further view of a pouch device in which a patient may keep diagnostic information concerning stroke symptoms and medication for treatment of stroke.  
         [0023]    [0023]FIG. 7 is a plan view of instruction sheets contained within the pouch device of FIGS. 5 and 6.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0024]    This invention provides a system and method for the rapid response to the onset of stroke by combining medical reviews, specific medical information, self diagnostic tests, instruction, and quality assurance to provide, pre-need, the resources necessary to reduce or eliminate impairment or death from stroke.  
         [0025]    This invention includes a protocol process that may be employed by any person previously determined eligible to use the system by medical doctors.  
         [0026]    This invention provides a system and method for the rapid response to the onset of stroke by combining medical review, specific medical information, self-diagnostic tests, instruction, and quality assurance to provide, pre-need, the resources necessary to reduce or eliminate impairment or death from stroke and includes a protocol process that may be employed by any person previously determined eligible to use the system by medical doctors.  
         [0027]    [0027]FIG. 1 shows the complete system in which the system (designated overall by the numeral  100 ) operates in its best mode. The process of applying for the system through receipt of emergency medical care is overviewed in FIG. 1 Recognition of Stroke onset  101  indicates that the applicant must realize they are at some risk of stroke. This recognition may be based upon such things as family history, age, high risk categories such as high blood pressure or arteriosclerosis, high cholesterol, geographic stroke pre-disposition (stroke-belt). After a person realizes they are at risk they apply for the program  102  typically by telephoning a call center. At the call center the operator takes a detailed personal and medical history from the applicant which includes such things as age, prior hospitalization, family history, chronic illness, current medications, prior stroke, and various other specific risk factors. This critical information is forwarded to medical doctors  103  who review the information obtained from the call center and follow-up with the applicant if necessary. Based on the review of this information, the medical doctor determines if the applicant is eligible for the program. If the doctor determines the program presents an unreasonable risk the program is not provided  104 . If the doctor determines, based on the information gathered from the applicant, that the program is suitable for use, and certain medication may be provided which is helpful, and the risk is acceptable, the program is provided  105 . When the program is provided the applicant receives a detailed packet which contains, information on identifying high-risk factors, information on reducing risk factors, general information on stroke, information of common symptoms of stroke, instructions on how to identify and respond to potential stroke onset, instructions and a self-test to determine the probability of stroke, instructions on when to use the medications provided. After the applicant receives the program  105  the applicant should begin to employ the information and instruction on how to reduce risk and prevention  106 . Prevention includes such things as stopping smoking, lowering cholesterol, controlling hypertension and monitoring blood-pressure, finding out if atrial fibrillation is present, eliminating heavy alcohol consumption, having a low sodium, low fat diet, evaluation for diabetes, close medical supervision of oral contraceptives, a regular exercise routine, and having medical evaluation of circulatory problems. However, despite being provided the program, a person may experience potential stroke onset  107  either before they implement prevention practices or despite implementing prevention practices. Potential stroke onset indicates that abnormal physical changes are occurring. The user will be aware of the potential stroke symptoms and be prepared to identify common symptoms  108  (see FIG. 2.- 201 ) Those symptoms are: ( 202 - 207 ) sudden headache; seizure; numbness in arms or legs; trouble speaking or confusion; trouble seeing in one or both eyes; and trouble walking or with balance. If any are present the person is to call 911 immediately. Or, the person may, unwisely, choose to do nothing and await outcome  109 . While awaiting emergency personnel arrival, or if no emergency service is available in the area, the person is to seek the assistance of a friend or neighbor to help in determining the likelihood of stroke  110  (see FIG. 3) If it is determined that there is not a high likelihood of stroke, use is not indicated  112 . If it is determined that there is a high likelihood of stroke, the person should continue with the evaluation to evaluate whether the use of the medication is appropriate  111  (see FIG. 4.) Even though there may be a high likelihood of stroke, medicinal use may not be appropriate  112 . If after evaluation  111 /FIG. 4 use is indicated  113  the medication is taken  114 . In either event, use indicated  114  or use not indicated  112  the person should report to an appropriate emergency medical care facility  115  and request immediate and timely evaluation and treatment (within three hours from onset).  
         [0028]    [0028]FIG. 2. depicts the process for identifying the potential onset of stroke by itemizing the most common symptoms and indicating appropriate action to be taken following onset. Potential stroke onset is indicated by abnormal physical symptoms occurring. The user of the system will be aware of the general symptoms of stroke and upon occurrence of abnormal physical changes will consult appropriate materials provided to determine if these are symptoms of stroke.  201  Those symptoms are: sudden headache  202 ; seizure  203 ; numbness in arms or legs  204 ; trouble speaking or confusion  205 ; trouble seeing in one or both eyes  206 ; and trouble walking or with balance  207 . If any of the above symptoms,  202 - 207 , are present the person is to call 911 immediately  209 . While awaiting emergency personnel they will proceed with the evaluation as set forth in FIG. 3.  301   
         [0029]    [0029]FIG. 3. shows one potential model of a test to determine the likelihood or probability of stroke based on a combination of symptoms and physical impairments. A series of YES/NO questions or tests are provided with a point value for each. The points are combined to determine probability of stroke. Based on the score the person is either instructed to continue on to next step, (FIG. 4)  311 , or to stop and seek medical care  312 . This test is to be administered by someone other than the stroke victim  301 . The questions or tests to be administered are:  
         [0030]    Does person know where they are?  302   
         [0031]    Does person know month, year, and their age?  303   
         [0032]    When asked to smile and show teeth, do both sides of person&#39;s face move equally?  304   
         [0033]    When asked to raise arms do both arms move at same speed and with same effort?  305   
         [0034]    When asked to walk, can person walk as they normally do with usual balance and stance?  306   
         [0035]    When asked about articles of clothing can person identify the article in an appropriate amount of time?  307   
         [0036]    When asked to repeat phrase, can person do so with normal speech without slurring?  308  The YES/NO scores  309  are then added for the total points  310 . If the total score is less than four (4), the person is instructed not to continue with the evaluation and not to take the medication provided  
         [0037]    If the total score is greater than four (4) the person is instructed to continue with the evaluation but not to take medication yet.  311   
         [0038]    The person will continue with the evaluation  312 .  
         [0039]    [0039]FIG. 4 depicts the preferred embodiment of the flow chart to determine if medicinal use is appropriate. Medicinal use is contingent upon presentation of symptoms of stroke and indication that the probability of stroke is high as well as appropriate indication after following flow chart. The person is queried about a multitude of symptoms which may or may not indicate use. The person is asked whether they had or have a headache? 
         [0040]    401. If yes, use is not indicated  
         [0041]    402. If no, they proceed to  
         [0042]    403, Does I did person have a loss of consciousness or awaken with symptoms? 
         [0043]    403. If yes, use is not indicated  
         [0044]    404. If no, they proceed to  
         [0045]    405, Does I Did person have seizure type episode? 
         [0046]    405. If yes, use is not indicated  
         [0047]    406. If no, they proceed to  
         [0048]    407, Did person strike head? 
         [0049]    407. If yes, use is not indicated  
         [0050]    408. If no, they continue to  
         [0051]    409, Does person have nausea or vomiting? 
         [0052]    409. If no, the person is instructed to take the medication and report for immediate emergency medical treatment.  
         [0053]    410. If yes, the person 15 instructed to continue to  
         [0054]    411, Does person have stiffness in neck? 
         [0055]    411. If no, the person is instructed to take medication and report for immediate emergency medical treatment.  
         [0056]    412. If yes, the person is instructed to continue on.  
         [0057]    413. Is person drowsy? 
         [0058]    413. If no, the person is instructed to take medication and report for immediate emergency medical treatment.  
         [0059]    414. If no, person is instructed to take medication and report for immediate emergency medical treatment.  
         [0060]    414. If yes, person is instructed not to take medication and report immediate emergency medical treatment.  
         [0061]    415. Regardless of whether medicinal use is indicated the person is to report as soon as possible to an appropriate care facility and request timely evaluation. Treatment protocols will be provided to the physician which outline treatment methods and indicate appropriate diagnostic tests.  
         [0062]    [0062]FIGS. 5 and 6 show a pouch  500 , constructed from a clear plastic sheet material, and shaped to resemble the shape of a credit card. The pouch  500  consists of a base  502  and a cover  501  which is hinged at one end to to one end of base  500 . Two round depressions  503  are formed in base  502 . Insert  600  consists of instruction sheets  601 ,  602 ,  603  and  604 . Sheets  601  and  602  are placed back-to-back and affixed to the inside of cover  501 . Sheets  603  and  604  are placed back to back and affixed to the inside of base  502 . With the instruction sheets  601 - 604  thus affixed, four distinct sets of instructions are provided as shown in FIG. 7.  
         [0063]    Sheet  601  is readable from the front, of transparent cover  501 . Sheet  602  is readable by lifting the hinged cover  501  and opening the pouch  500 . Sheet  603  is readable when the cover  501  is opened. The sheet  604  is readable by turning the transparent base  502  over, to view through the back side.  
         [0064]    Prescription medication, in the form of tablets or capsules  504 , provided and held in position by within the depressions  503  or  503   a  as shown in FIGS. 5 and 5 a . The instructions advise the user to take the medications when signs of stroke, as listed on the instruction sheets  601 - 604  warrant the use of the medication. Use of the medication as instructed by the invention, provides a means for reducing the impairment, disability, and death caused by strokes.  
         [0065]    Those skilled in the art will recognize that the method and apparatus of the present invention has many applications, and that the present invention is not limited to the representative examples disclosed herein. Moreover, the scope of the present invention covers conventionally known variations and modifications to the system components described herein, as would be known by those skilled in the art. Although the discussion addresses the acute medical need and provides a program to improve treatment and access for stroke. This program of medical review and provision of direction and immediate treatment to applicable to other acute medical conditions with modification or new written protocols.