Abstract:
A tracking device and system for tracking medical supplies, in particular, medical trays and their components is disclosed. The tracking device utilizes GPRS/GSM technology to enable an individual to locate and monitor the movement of a medical tray at any given time and for any desired period of time. The tracking system utilizes geo-fences established within buildings to assist in determining the specific location of the medical trays within these buildings. The tracking devices can also be activated by motion sensors to alert the tracking system of a possible theft of the tray. The tracking system incorporates software which enables an individual to determine the location of medical trays, determine the contents of the trays and schedule the use of the medical trays by specific doctors and at specific locations. The tracking system also retains information regarding the doctors, the medical device manufacture representatives, the hospitals and sales of the medical devices.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 11/861,858, filed Sep. 26, 2007, entitled, “MEDICAL SYSTEM AND TRACKING DEVICE”, the entirety of which is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to medical supplies and in particular to an apparatus and system for tracking and locating these medical supplies. 
       BACKGROUND OF THE INVENTION 
       [0003]    Recent advances in medical technology and procedures have yielded a number of devices including spinal implants; hip, knee, shoulder and other orthopedic replacements; pacemakers and other implantable devices. These devices are very costly and normally require the presence of a manufacture&#39;s representative to assist the surgeon in utilizing the device properly. These devices are shipped from the manufacture to the hospital in surgical trays. These surgical trays include the medical device and any other equipment required during the medical procedure to install or implant the device. The cost of these medical devices and related equipment is very high, usually exceeding tens of thousands of dollars. This has resulted in a black market for these medical devices. 
         [0004]    These surgical trays, including the medical devices, must be available when the surgeon is scheduled to perform the operation. In many instances, like hip and knee replacement, the medical devices are specifically sized for the individual patient. Therefore, an inventory of these devices cannot be maintained in the hospital. If the specific surgical tray required for a surgery cannot be located, the surgery must be postponed. This results in unnecessary costs on behalf of the surgeon and hospital. In addition, these surgical trays, including all of their components, must be sterilized prior to their use. 
         [0005]    Another problem is theft of the trays between the manufacturing facility and the operating room. Once the surgical tray is delivered to the hospital and someone accepts shipment, the surgical tray becomes the property and responsibility of the hospital. There have also been instances of theft within the hospitals. In some instances the trays have been shipped to the incorrect hospital and this has not been discovered until the day of the surgery. This shipping error will again result in postponement of the surgery and related expenses. 
         [0006]    Therefore, what is needed in the art is a tracking device and system for tracking these surgical trays and other medical supplies from the manufacturer to the operating room. This would enable the medical device manufacture&#39;s field representative to locate and monitor the surgical tray containing the medical device from the time is left the manufacturing facility until it arrived in the operating room. The system is also capable of ordering additional supplies and billing for the use of the medical supplies and equipment. 
       DESCRIPTION OF THE PRIOR ART 
       [0007]    U.S. Published Patent Application No. 2006/0017545 discloses a tracking system for monitoring the location of an object or a group of objects using RFID tags. These tags must be passed by an interrogator or tracking device to be detected. If the RFID devices are not within the range of the tracking devices, such an in a hospital store room, the tracking devices are unable to located the RFID devices. Some of these RFID tags can include a GPS feature to report their location. However, if the tags cannot communicate with the GPS satellites, such as when they are located within buildings, their location cannot be determined. Therefore, this system is not practical when tracking medical trays in hospitals. 
         [0008]    U.S. Pat. No. 7,158,754, issued to Anderson and U.S. Pat. No. 7,158,030, issued to Chang, both disclose RFID tags which can be encapsulated on or attached to medical devices. These tags can only be tracked when they are passed by an interrogator or other tracking device. They cannot be located by tracking devices positioned outside of the building when they are within the building. 
       SUMMARY OF THE INVENTION 
       [0009]    Briefly, the present invention is directed toward a tracking device and system for tracking medical supplies, in particular, medical trays and their components. The tracking device utilizes GPRS/GSM technology to enable an individual to locate and monitor the movement of a surgical tray at any given time and for any desired period of time. The tracking system utilizes geo-fences established within buildings to assist in determining the specific location of the surgical trays within these buildings. Whenever a surgical tray passes one of these geo-fences the tracking device is activated and a signal is sent to an individual or device monitoring the location of the surgical tray. The tracking devices can also be activated by motion sensors to alert the tracking system of a possible theft of the surgical tray. The tracking system can also be programmed so the tracking device transmits its position at specific time intervals. The tracking device can also utilize other wireless communications such as Bluetooth or Wi-Fi. 
         [0010]    The tracking device is normally attached to a surgical tray in a manner such that only the individual who installed the tracking device or company providing the tracking service can remove the tracking device. This prevents the tracking device from being removed from the surgical tray and left at a known location, such as the store room of a hospital, while the surgical tray is stolen. Normally the only time the tracking device needs to be removed from the surgical tray is to replace the batteries. The tracking device can also be equipped with a pager or beeper to assist in determining its location in large store rooms. 
         [0011]    The tracking device is also weather/water proof and capable of withstanding elevated temperatures, such as those encountered in an autoclaving process. The tracking device includes a shock and heat absorption insulation system to protect the device. 
         [0012]    Accordingly, it is an objective of the instant invention to provide a system for tracking a medical device tray and its contents at all locations including inside of buildings. 
         [0013]    It is a further objective of the instant invention to provide a tracking device which can withstand the medical instruments sterilization environments. 
         [0014]    It is yet another objective of the instant invention to provide a system for tracking medical devices which includes information regarding the intended user of the devices, the location at which the devices are to be used and the representative of the device manufacturer. 
         [0015]    It is a still further objective of the invention to enable the medical devices to be ordered and shipped to the desired locations when required. 
         [0016]    Other objects and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0017]      FIGS. 1  A-D are an overall flow chart of the various aspects of the data base and how they are connected; 
           [0018]      FIGS. 2  A-D are a flowchart similar to  FIGS. 1  A-D with some additional information; 
           [0019]      FIG. 3  is a web page of the system illustrating the scheduling of surgeries; 
           [0020]      FIG. 4  is a web page of the system illustrating how data is entered regarding medical devices representatives; 
           [0021]      FIG. 5  is a web page illustrating the color codes on the charge sheet; 
           [0022]      FIG. 6  is a web page for entering hospital data; 
           [0023]      FIG. 7  is a web page for obtaining hospital data; 
           [0024]      FIG. 8  is a web page illustrating medical device information; 
           [0025]      FIG. 9  is a web page for entering surgical procedure information; 
           [0026]      FIG. 10  is a web page illustrating a schedule of surgeries; 
           [0027]      FIG. 11  is a web page illustrating surgeons information; 
           [0028]      FIG. 12  is a web page illustrating medical tray availability; 
           [0029]      FIG. 13  is a web page illustrating inventory orders for medical trays; 
           [0030]      FIG. 14  is a web page illustrating the location of medical trays; 
           [0031]      FIGS. 15  A-C illustrates an embodiment of a tracking device for a medical tray; 
           [0032]      FIGS. 16  A-C illustrates another embodiment of a tracking device for a medical tray and 
           [0033]      FIG. 17  illustrates another embodiment of a tracking device for a medical tray. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0034]    While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred, albeit non limiting, embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated. 
         [0035]    A system and method for tracking an object, an article or an individual as it moves along a path is disclosed hereinafter. The system and method of the present invention do not require input from an individual whenever the object or article moves from one location to another. A position indication device such as a RFID (Radio Frequency Identification) and/or GPS (Global Positioning System) device is attached directly to or located in close proximity to the article or object which is being tracked. Various types of GPS systems which are available for use include National Differential GPS System (NDGPS); Wide Area Augmentation System (WAAS); Continuously Operating Reference Station (CORS); Global Differential GPS (GDGPS) and International GNSS Service (IGS). Other types of position indicating devices may be used in place of the RFID or GPS devices. The positioning indicating device will transmit its location utilizing GPS (Global Positioning System); GSM (Global System for Mobile communications); CDMA (Code Division Multiple Access); or SMS (Short Message Service) technologies or a combination thereof. 
         [0036]    The system is accessed through a web site wherein medical device reps, surgeons, hospital personnel and surgical device manufactures can access information relating to the medical trays and their location. The trays can be ordered and transferred utilizing this web site. The costs of the trays can also be billed at this web site. 
         [0037]      FIG. 1  illustrates how the various menus are linked to each other so that the medical device reps can access all the information pertaining to the trays and the surgical procedures in which they are to be used. The various menus illustrated in  FIG. 1  include, the Rep Surgeons, the Surgeon Family Members, the Surgeon Phones, the Surgeon Documents, the Surgeon Hospital Affiliations, the Charge Detail Sheet, the Charge Sheet Header, the Surgeons, the Surgeon Procedures, the Order for Surgery Trays, the Rep Procedures, the Tray Location Tracking, the Surgery Booking, the Hospitals, the Trays, the Tray Classes, the Tray Types, the Inventory Locations, the Order for Surgery Items, the Tray BOM, the Distributor or Hospital, the DH Pricing, the Items, the Location Inventory, the Item Lots, the Product Line, the Distributor Hospitals Reps, the Distributors, the Item Types, the Item Groups, the Reps, the Alert Recipients, the Alerts, the Alert Frequencies, the Rep Supervisors and the Rep Commission. 
         [0038]      FIG. 2  also illustrates how various menus are linked to each other so that the medical device reps can access all the information pertaining to the trays and the surgical procedures in which they are to be used. The various menus illustrated in  FIG. 2  include the Charge Sheet Detail, the Charge Sheet Header, the Surgeons, the Surgeon Procedures, the Surgery Booking, the Tray Location Tracking, the Hospitals, the Trays, the Tray Classes, the Tray Types, the Inventory Locations, the Tray BOM, the Distributor Hospital, the DH Pricing, the Items, the Location Inventory, the Item Lots, the Product Line, the Distributor Hospital Reps, the Distributors, the Item Types, the Rep Supervisors, the Reps, the Alert Recipients, the Alerts, the Alert Frequencies and the Rep Commission. 
         [0039]    An example of the case coverage for different surgical procedures is illustrated in  FIG. 3 . For example on Monday, Sep. 10, 2007, the time and type of the procedure is listed at the top, 7:00 AM-TLIF. Next the name of the surgeon is listed, Argent Agrawal. Next the hospital where the procedure is being done is listed, North Fulton Regional Hospital. Next the name of the medial device rep. present at the procedure is listed, Jeffery Smith. Finally if the rep. is not available his replacement is listed, Jason Graves. The charge sheet menu appears in all of the web pages. This enables the user to quickly access the information that he or she is seeking. 
         [0040]    An example of the information with respect to each surgical rep. is illustrated in  FIG. 4 . The reps. personal information is available including how he can be contacted. The surgeons he is assigned to are also illustrated. The surgical procedures in which he has an expertise are listed. His commissions for the use of various medical devices are listed. Finally, all personal that he supervises are also listed. 
         [0041]      FIG. 5  is a menu of the various colors which are assigned to various events. For example, doctor visits are navy, Surgeon training is blue and hospital in-service is red. These colors are utilized in the case coverage illustrated in  FIG. 3 . Hospital information is illustrated in  FIG. 6 . A list of the hospitals which utilize the medical trays is provided. When a particular hospital is selected the address and location of the hospital is provided. Also information regarding billing is provided. Another method of accessing hospital information is illustrated in  FIG. 7 . The hospital or billing contact can be searched in the system. This web page also includes a quick contact information list. 
         [0042]    The contents of the various medical trays is illustrated in the web page in  FIG. 8 . A description of each of the items including a photograph, the procedure in which they are used, the cost of the items and the manufacturer are readily available. An inventory of the various trays is also available. Utilizing this information the surgical rep. can familiarize himself or herself with the contents of each tray prior to the surgical procedure. 
         [0043]    The information with respect to different surgical procedures and the medical trays required for the procedures is illustrated in  FIG. 9 . The rep. can select the various trays which the surgeon will need or has requested for the procedure. This information is submitted to the system to indicate the availability of the trays and if certain trays must be supplied from other locations. If this is the case then an order is placed and the required tray is shipped to the desired location. 
         [0044]      FIG. 10  illustrates a medical rep&#39;s calendar. His surgeries and other activities are on the calendar. He can also access he sales information, track the medical inventory and access information with respect to his contacts. All of this can be done where ever he has access to the Internet. An example of the information regarding specific surgeons is illustrated in  FIG. 11 . With this information he is better equipped to establish a working relationship with the surgeon. Should the rep. need information regarding specific tray, he can also access this as illustrated in  FIG. 12 . This information includes an identification of the trays, the location of the trays, information regarding a hospital at which the tray is required, the date on which the tray is to arrive at the hospital, the date of the surgery and the date the tray will be available again if it is not needed for the surgery. 
         [0045]    An inventory of tray orders is illustrated in  FIG. 13 . The date of the surgery, the surgeon&#39;s name, the specific tray required, the hospital and the rep&#39;s name assigned to the tray are provided. The rep can then locate an appropriate tray and assign it to the surgery. A list of the trays available is illustrated in  FIG. 14 . This information lists the specific trays, the location of the tray, if the tray has already been purchased by the hospital and any special notes regarding the tray. The notes are indicated by an icon next to the tray class. 
         [0046]    Various tracking devices for the medical trays are illustrated in  FIGS. 15-17 . In  FIGS. 15A and 15B  the medical tray of the present invention is indicated as 10. The tray normally comprises a rectangular closed box. The surgical instruments (not shown) are arranged within the tray to insure proper sterilization. The tray is preferably composed of a nylon-like thermo-resistant polymer exterior  13  and has a similar interior. Other materials with the desired properties could also be utilized. The tracking device  14  is located in the lower portion of the tray,  FIG. 15B . The tracking device is placed in the lower portion of the tray in a silicone foam material  16 . The silicone foam functions as both an insulator and a shock absorption device. The medical trays are normally sterilized at temperatures above 270° F. and the silicone foam helps protect the tracking device from these high temperatures. Once the tracking device is placed in the lower portion of the tray  10  an access door  18  is secured in a manner that prohibits unauthorized personnel from accessing the tracking device. The access door is preferably provided with waterproof and heat resistant seal (not shown). The access door is used for battery replacement in the power source. The foam can be a silicone/polyamide or a silicone/polyimide. The tracking device  14 , as illustrated in  FIG. 16A , comprises a power source  20 , a motion sensor  22 , and a communicator or first transceiver  24  which utilizes GSM, GPRS, CDMA, SMS and/or Bluetooth to communicate the location of the medical tray. An individual seeking the location of the medical tray can establish contact with the tracking device with their mobile phone or second transceiver. The tracking device will then indicate the location of the medical tray. This type of communication system permits the tracking of medical trays inside of buildings where GPS devices will not function. The individual&#39;s mobile communication device (second transceiver) or another communication device (second transceiver) can be programmed to ping the tracking device at regular intervals. This helps conserve the batteries in the power supply of the tracking device. The motion sensor  22  triggers the communicator or first transceiver  24  when ever the tray is moved. 
         [0047]    A second embodiment of the tracking device is illustrated in  FIGS. 16  A-C. This tracking device is secured around the outer periphery of the medical tray. This is known as the “Halo” design. The tracking device is located in the main element  26  of the device. The tracking device includes a motion sensor  22 , a power supply  20  and a communicator or first transceiver  24 . An access door or panel (not shown) provides access to the tracking device to enable battery replacement or other operations. The access door cannot be readily accessed by unauthorized personnel and is normally located on the rear side of the main element  26 . The main element  26  is provided with legs or extensions  28 . These legs connect to corner elements  30 . The legs are secured to the corner elements utilizing rivets or other fasteners  32 . A connection member  34  secures corner elements together, as illustrated in  FIG. 16C . The corner elements  30  are designed to connect to each other when they are secured to a conventional sized medical tray. Connection members  34  can also be utilized to connect corner elements  30  to each other whenever the width of the medical tray is larger than normal. A connection member  34  is illustrated in  FIG. 16B . The connection member  34  is provided with zip-tie like one way connectors  36  at both ends of the connection member. These connectors allow the connection member to be inserted into the corner elements but not withdrawn therefrom. After these elements have been connected to each other, additional fasteners such as rivets  32  are also used to secure the elements together. Connectors  36  are also provided on the main element  26  as illustrated in  FIG. 16A . The medical tray is formed from the same material as the tray of the embodiment of  FIGS. 15  A-C. Thermo resistant foam can also be utilized in the main element to protect the tracking device. 
         [0048]    A third embodiment of the tracking device is illustrated in  FIG. 17 . The tracking device is positioned in a housing  40  which is secured to an outer portion of a medical tray  10 . Straps  42  secure the housing  40  to the medical tray. Rivets  44  or similar fasteners secure the straps  42  to the medical tray. The fasteners are designed so they are not removable by unauthorized personnel. An access door or panel (not shown) provides access to the interior of housing  40  for battery replacement or access to the tracking device. A handle  46  can be provided on the medical tray to assist in transporting the tray. The medical tray is formed from the same material as the tray of the embodiment of  FIGS. 15  A-C. Thermo resistant foam can also be utilized in the housing  40  to protect the tracking device. 
         [0049]    All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. 
         [0050]    It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein. 
         [0051]    One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.