Abstract:
A method for protecting a parameter settings report for an implanted medical device is disclosed. The method comprises the steps of receiving a parameter settings report for an implanted medical device from a medical facility; folding the parameter settings report is folded into a compact size; opening a container, wherein that container includes a base piece and a cover piece with the base piece including a plurality of side walls, an open top side defined by the plurality of sidewalls, and an internal storage volume; placing the folded parameter settings report into the container; and closing the container.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/779,160, filed Mar. 3, 2006, which application is incorporated herein by reference in its entirety. 
     
    
     TECHNICAL FIELD  
       [0002]     The present invention relates generally to containers and storage methods.  
       BACKGROUND  
       [0003]     Implantable medical devices (IMD) are commonly used to treat patients having abnormal or irregular cardiac rates or rhythms. A typical IMD is a pacemaker. A pacemaker is used to monitor a patient&#39;s heart rate, and is designed to increase the patient&#39;s heart rate with a series or pattern of electrical impulses if the patient&#39;s heart rate falls below a predetermined level. Another type of MD is an implantable cardioverter defibrillator (ICD). An ICD monitors a patient&#39;s heart rate and is designed to slow a patient&#39;s heart rate with one or more electrical shocks if the patient&#39;s heart rate exceeds a predetermined level.  
         [0004]     When an IMD is implanted in a patient, a relatively large number of parameters are set to optimize performance of the IMD with respect to the patient. The parameter settings are typically provided to the patient on a Parameter Settings Report. A Parameter Settings Report may also include hemodynamic data for the patient. Example parameters and hemodynamic data can be found at U.S. Pat. No. 6,792,310 and U.S. Pat. No. 7,003,349 which are hereby incorporated by reference in their entireties. Further parameters and hemodynamic data can be found at US Patent Application Publication No. US 2004/0220636 A1, which is also hereby incorporated by reference in its entirety. After initial implantation, patients typically periodically visit their physicians to verify the operating condition and performance of their IMD. With each visit, parameter settings for the IMD may be modified and updated Parameter Settings Reports can be provided to the patients.  
         [0005]     In the event of a heart-related medical emergency involving a person having an IMD, the Parameter Settings Report for the IMD is a valuable tool for use in diagnosing and treating the patient. For this reason, a patient having an IMD is encouraged to have his or her Parameter Setting Reports readily accessible at all times. Frequently, the patients place the Parameter Settings Reports in their wallets or purses. This is problematic because the Parameter Settings Reports are difficult to locate and may become smeared, blurred or otherwise damaged thereby rendering the reports difficult to read.  
       SUMMARY  
       [0006]     One aspect of the present disclosure relates to a container for storing a Parameter Settings Report corresponding to an IMD. In certain embodiments, the container is small enough to easily be kept in a patient&#39;s pocket. In certain embodiments, the container has a plastic construction that prevents the Parameter Settings Report held within the container from being bent, crushed or otherwise damaged. In still other embodiments, the container has a hinged or removable lid for allowing the Parameter Settings Report to be easily accessed within the container. In still further embodiments, the container can have exterior indicia for allowing a third party to readily recognize that important medical information is held within the container.  
         [0007]     Another aspect of the present disclosure relates to a method for protecting a parameter settings report for an implanted medical device. A parameter settings report for an implanted medical device is received from a medical facility. The parameter settings report is folded into a compact size. A container is opened, wherein that container includes a base piece and a cover piece with the base piece including a plurality of side walls, an open top side defined by the plurality of sidewalls, and an internal storage volume. The folded parameter settings report is placed into the container and the container is closed.  
         [0008]     A variety of additional inventive aspects will be set forth in the description that follows. The inventive aspects can relate to individual features and to combinations of features. It is to be understood that both the forgoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the broad inventive concepts upon which the embodiments disclosed herein are based. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]     The accompanying drawings are included to provide a further understanding of the present invention and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present invention and together with the description serve to further explain the principles of the invention. Other aspects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the present invention becomes better understood by reference to the following Detailed Description when considered in connection with the accompanying drawings, and wherein:  
         [0010]      FIG. 1  is a front, left, top perspective view of a container in accordance with the principles of the present disclosure for storing and protecting a Parameter Settings Report of an IMD;  
         [0011]      FIG. 2  is a left, side view of the container of  FIG. 1 ;  
         [0012]      FIG. 3  is a front view of the container of  FIG. 1 ;  
         [0013]      FIG. 4  is a right, side view of the container of  FIG. 1 ;  
         [0014]      FIG. 5  is a top view of the container of  FIG. 1 ;  
         [0015]      FIG. 6  is a rear view of the container of  FIG. 1 ; and  
         [0016]      FIG. 7  is a bottom view of the container of  FIG. 1 .  
     
    
     DETAILED DESCRIPTION  
       [0017]     Reference will now be made in detail to the exemplary aspects of the present invention that are illustrated in the accompanying drawings. Whenever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.  
         [0018]      FIG. 1  shows a container  20  having features that are examples of inventive aspects in accordance with the principles of the present disclosure. The container  20  can also be referred to as a case, a box, a cartridge, a package, or other like terms. The container  20  is preferably sized to hold a Parameter Settings Report of an IMD. The container  20  is also preferably sized to easily fit within a patient&#39;s pocket or purse to allow the patient to carry the Parameter Settings Report with them at all times.  
         [0019]     Referring still to  FIG. 1 , the container  20  includes a base piece  22  defining an internal storage volume  24  sized for holding a Parameter Settings Report. A top side  25  of the base piece  22  is open. The container  20  also includes a cover piece  26  that is used to close the open top side  25  of the base piece  22 . As depicted in  FIG. 1 , the cover piece  26  is connected to the base piece  22  by a living hinge  28 . In one example embodiment, the container  20  is a molded plastic part having sufficient rigidity to prevent a Parameter Settings Report positioned within the container from being unintentionally folded, bent or crushed.  
         [0020]     Referring to  FIGS. 1, 2  and  5 , the base piece  22  of the container  20  includes a generally rectangular bottom wall  30  that defines a major bottom side of the container  20 . The base piece  22  also includes a sidewall structure  32  that projects upwardly from the bottom wall  30 . A curved/contoured transition  33  is provided between the bottom wall  30  and the sidewall structure  32 .  
         [0021]     The sidewall structure  32  defines a generally rectangular perimeter of the container  20 . It also cooperates with the bottom wall  30  to define the rectangular internal storage volume  24 . The sidewall structure  32  includes opposing sidewalls  38 ,  40  that define a width W of the container  20 , and opposing sidewalls  42 ,  44  that extend between the sidewalls  38 ,  40  and define a length L of the container  20 . The sidewalls  38 ,  40  are connected to the sidewalls  42 ,  44  by rounded corners.  
         [0022]     The open top side  25  of the base piece  22  is defined by the inner surface of a lip  34  that projects upwardly from the sidewall structure  32 . An exterior shoulder  36  is defined at the junction between the bottom of the lip  34  and the top of the sidewall structure  32 .  
         [0023]     Referring to  FIGS. 1, 2 ,  4 ,  5 ,  6  and  7 , the cover piece  26  is also rectangular and is sized to fit over the lip  34  of the base piece  22  to enclose the internal storage volume  24  of the container  20 . The cover piece  26  includes a top wall  45  that defines a major top side of the container  20  when the container  20  is closed. The top wall  45  of the cover piece  26  opposes and is generally parallel to the bottom wall  30  of the base piece  22  when the container  20  is closed.  
         [0024]     The cover piece  26  includes a rim  46  that extends around the perimeter of the cover piece  26 . A curved/contoured transition  47  is provided between the top wall  45  and the rim  46 . The cover piece  26  also includes an internal shoulder  48  that also extends around the perimeter of the cover piece  26  and is recessed relative to the rim  46 . When the cover piece  26  is closed on the base piece  22 , the rim  46  seats upon the exterior shoulder  36  of the base piece  22 , and the internal shoulder  48  abuts against the lip  34  of the base piece  22 .  
         [0025]     The cover piece  26  also includes two recesses  50  sized to receive corresponding tabs  52  provided on the base piece  22 . When the cover piece  26  is closed on the base piece  22 , the tabs  52  snap within the recesses  50  to retain the cover piece  26  in the closed position. The base piece  22  also includes an exterior finger recess  54  that provides clearance for allowing a user to place their finger beneath a portion of the rim  46  to facilitate opening the cover piece  26 .  
         [0026]     It is preferred for the container  20  to include exterior indicia or markings to allow a third party (e.g., a paramedic, a nurse or a treating physician) to readily recognize the contents of the container  20 . For example, the indicia can be written on the container, placed on a sticker on the container, or molded into the exterior surface of the container. Example text that may be provided on the container include “Medical Information”, “Pacemaker Parameter Settings Report Enclosed”, “ICD Parameter Settings Report Enclosed” or like descriptions. Other information can also be provided on the exterior of the container. For example, the exterior indicia of the container may list the patient&#39;s name, phone number and address. The indicia may also include the treating physician&#39;s name (i.e., the physician that installed the IMD and generated the Parameter Settings Report) as well as the treating physician&#39;s phone number and address.  
         [0027]     It is preferred for the container  20  to be sized to receive a conventional Parameter Settings Report while still being sufficiently small to allow the patient to readily carry the container with them at all times. An example Parameter Settings Report may include six paper panels each about 4½ inches wide and 6 inches long. The panels are typically connected by perforated edges. By folding the panels at the perforated edges and then further folding the panels, the report can be compacted to a reasonable size capable of being carried by a patient.  
         [0028]     It is preferred for the container  20  to be reasonably small. In one embodiment, the length L of the container is less than 4 inches, the width W of the container is less than 3 inches, and a thickness of the container (the distance between the outer surfaces of the top and bottom walls when the container is closed) is less than 0.75 inches. In the preferred embodiment, the container has a length of about 3.3 inches, a width of about 2.5 inches, and a thickness of about 0.625 inches. In alternative embodiments, the container may have a tapered thickness that tapers along the width of the container so that one side of the container is thicker than the other side of the container.  
         [0029]     In use, a patient will visit his or her attending physician and will receive a Parameter Settings Report for their implanted medical device. Upon receiving the report, the patient will fold the report and place the report in the container  20 . Once in the container, the report is protected from being further folded, bent, smeared, torn, or otherwise damaged. The report is also protected from getting wet. The patient then carries the container  20  with them at all times. In the event the patient has a heart-related medical emergency, the indicia on the container allows treating personnel to quickly find and read the Parameter Settings Report. This assists in providing a timely diagnosis and treatment for the patient.  
         [0030]     It will be appreciated that containers in accordance with principles of the present disclosure can be distributed by physicians, hospitals, and/or IMD manufacturers as part of a program for encouraging patients to carry their Parameter Settings Reports with them at all times.  
         [0031]     Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention, and it should be understood that this invention is not to be unduly limited to the illustrative embodiments set forth herein.