Abstract:
A method and apparatus for billing entities for use of a medical device, which relates to the processing of regenerative cells to facilitate at least one of hard and soft tissue formation, are described. When an operator uses the medical device, a corresponding charge is determined. Billing for usage of the medical device is performed on a periodic or per-use basis. Communication over a network facilitates remote management and servicing of the medical device. Support is provided for automatic ordering of supplies consumed by the medical device.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. ______, filed Jan. 10, 2005 and entitled DEVICES AND METHODS FOR INDUCING TISSUE FORMATION AND BILLING A USER OF THE DEVICES AND METHODS. This application further is a continuation-in-part application of U.S. application Ser. No. 10/884,638, filed Jul. 2, 2004 and entitled “SYSTEMS AND METHODS FOR ISOLATING AND USING CLINICALLY SAFE ADIPOSE DERIVED REGENERATIVE CELLS,” which is a continuation-in-part of U.S. application Ser. No. 10/316,127, filed Dec. 9, 2002 and entitled “SYSTEMS AND METHODS FOR TREATING PATIENTS WITH PROCESSED LIPOASPIRATE CELLS,” which claims the benefit of U.S. Provisional Application No. 60/338,856, filed Dec. 7, 2001. The contents of all the aforementioned applications are expressly incorporated herein in their entirety by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates generally to methods and apparatus for monitoring medical devices, e.g., charging for use of medical devices, as well as methods and apparatus for managing and servicing medical devices, e.g., remotely managing and servicing medical devices. More particularly, the present invention relates to providing methods and apparatus for charging for use of a medical device for separating and concentrating clinically safe regenerative cells from adipose tissue. 
         [0004]    2. Description of Related Art 
         [0005]    As can be understood from the description of related art presented in the aforementioned applications, which are herein incorporated by reference, a need exists for apparatus, devices, systems and methods for extracting regenerative cells from adipose tissues in a matter suitable for direct placement into a recipient. Because application of such apparatus, devices, systems and methods to practical problem solving related to monitoring, managing and servicing incurs an associated cost, an additional need exists for methods and apparatus capable of aiding in the recovery of such costs. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention addresses the need for monitoring usage of a medical device, such as a medical device capable of inducing hard or soft tissue formation, by providing a medical device capable of inducing hard or soft tissue formation, wherein the medical device causes a user to be billed for use of the medical device. An embodiment of the invention herein disclosed comprises a concentrator capable of concentrating regenerative cells from tissue to form a composition capable of being placed into a patient to induce at least one of hard and soft tissue formation. 
         [0007]    Another embodiment of the present invention comprises a medical billing device comprising a storage device, a printer, and a processor. The processor in this embodiment may be programmed to receive a usage event and to print on the printer a report describing a user charge according to the usage event. 
         [0008]    Another embodiment of the present invention comprises a method of billing a user of at least one medical device. An implementation of this method comprises maintaining a database of user charge codes and usage events according to the at least one medical device and receiving a usage event and a user charge code. A billed amount then may be determined according to the usage event and the user charge code, and a report may be generated according to the billed amount. In other embodiments, the present invention comprises methods and apparatus for managing and servicing the medical devices. In certain embodiments, the medical devices can be managed and/or serviced remotely. Such embodiments can comprise a medical device such as the medical devices capable of inducing hard or soft tissue formation that is connected to a wired or wireless network. Methods, apparatus and advantages of such embodiments are further described herein. 
         [0009]    While the apparatus and method has or will be described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 U.S.C. 112, are not to be construed as necessarily limited in any way by the construction of “means” or “steps” limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 U.S.C. 112 are to be accorded full statutory equivalents under 35 U.S.C. 112. 
         [0010]    Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one skilled in the art. For purposes of summarizing the present invention, certain aspects, advantages and novel features of the present invention are described or incorporated by reference herein. Of course, it is to be understood that not necessarily all such aspects, advantages or features will be embodied in any particular embodiment of the present invention. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims that follow. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1  is a partial block diagram of a medical device capable of inducing hard or soft tissue formation according to the present invention; 
           [0012]      FIG. 2  is a block diagram of a programmable processing device; 
           [0013]      FIG. 3  is a pictorial diagram depicting a medical billing device; 
           [0014]      FIG. 4  is a chart illustrating a data structure for storing charge codes and rates; 
           [0015]      FIG. 5  is a chart describing a data structure for storing record of medical device usage events; 
           [0016]      FIG. 6  is a chart depicting a report comprising a bill according to a single use of a medical device; 
           [0017]      FIG. 7  is a chart illustrating a report comprising a periodic billing for uses of medical devices; 
           [0018]      FIG. 8  is a flow diagram describing an implementation of a method of billing a user for use of one or more medical devices; 
           [0019]      FIG. 9  is a table listing instruction sequences included in an exemplary medical billing device; 
           [0020]      FIG. 10  is a flow diagram describing an implementation of a method for creating a report according to usage data for one or more medical devices; 
           [0021]      FIG. 11  is a flow diagram depicting an example of automated inventory management, ordering, and billing according to the present invention; 
           [0022]      FIG. 12  is a table comprising a usage report generated according to the present invention; and 
           [0023]      FIG. 13  is a chart illustrating an example of a usage report presented in graphical form. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0024]    Reference will now be made in detail to the presently preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers are used in the drawings and the description to refer to the same or like parts. It should be noted that the drawings are in simplified form and are not to precise scale. In reference to the disclosure herein, for purposes of convenience and clarity only, directional terms, such as, top, bottom, left, right, up, down, over, above, below, beneath, rear, and front, are used with respect to the accompanying drawings. Such directional terms should not be construed to limit the scope of the invention in any manner. 
         [0025]    Although the disclosure herein refers to certain illustrated embodiments, it is to be understood that these embodiments are presented by way of example and not by way of limitation. The intent of the following detailed description, although discussing exemplary embodiments, is to be construed to cover all modifications, alternatives, and equivalents of the embodiments as may fall within the spirit and scope of the invention as defined by the appended claims. It is to be understood and appreciated that the process steps and structures described or incorporated by reference herein do not cover a complete process flow for the implementation of medical billing devices. The present invention may be practiced in conjunction with various medical devices that are conventionally used in the art, and only so much of the commonly practiced process steps are included herein as are necessary to provide an understanding of the present invention. The present invention has applicability in the field of medical devices and processes in general. For illustrative purposes, however, the following description pertains to a medical device capable of isolating and using clinically safe adipose derived regenerative cells and to a method of billing for use of the medical device. 
         [0026]    Referring more particularly to the drawings,  FIG. 1  is a partial block diagram of an example of a medical device capable of inducing hard or soft tissue formation according to the present invention. Elements of the invention are grouped in  FIG. 1  so as define a system (e.g., a partially or fully automated system) or concentrator  20  comprising a programmable processing device  32  (e.g., a microprocessor or personal computer). One exemplary embodiment of a system and programmable processing device is described with reference to FIG. 4 of the above-referenced U.S. application Ser. No. 10/884,638. However, many other embodiments of varying constructions and complexities, both larger and smaller, are also contemplated to be within the scope of the present invention. The system (e.g., concentrator)  20  can comprise, for example, a chamber assembly  22  and a concentration device  28 . In a typical embodiment, the chamber assembly  22  may comprise a tissue collection chamber that receives tissue through a conduit  23  and that may be controlled by a control and communication path  24  that is coupled to the programmable processing device  32 . Received tissue may be processed, for example, washed, in the chamber assembly  22  and then passed to the concentration device (e.g., processing chamber)  28 , which may comprise for example a centrifuge, through another conduit  26 . 
         [0027]    The concentration device  28  may be operated under control of control and communication path  27  that is coupled to the programmable processing device  32  to produce a composition that, when placed into a patient, may induce at least one of hard and soft tissue formation. The placing into a patient may be achieved using techniques well known in the art. For example, the composition may be suspended in a solution, the solution drawn into a syringe, and the solution injected into the patient from the syringe. In another embodiment, the composition may be applied onto an implant, and the implant may be inserted into the patient. 
         [0028]    In typical embodiments, concentrated material (comprising, for example, regenerative cells) passes to an output device, such as, for example, an intervascular delivery device  30 , through yet another conduit  29  for, as an example, infusion into a patient. In other embodiments, the concentrated material passes to a secondary device, such as, for example, a bioreactor module  30 , through a conduit  29 , for further purification or processing before passing to an output device, such as, for example, an intervascular delivery device  30 , through a conduit (not shown) for infusion into a patient. The concentrated material can be manually retrieved using, for example, a syringe. In other embodiments, the concentrated material (e.g., a final pellet or other composition comprising regenerative cells) may be automatically moved to a container which may be removed and stored or used as needed. This container may be in any appropriate form or size. For example, the container may even be a syringe. In certain embodiments, the output device may be heat sealed (either automatically or manually) and isolated from the other components of the concentration device for subsequent retrieval and use of the concentrated material in therapeutic applications as described or incorporated by reference herein including re-infusion (e.g., re-implantation) into the patient. The concentrated material may also be subject to further processing as described or incorporated by reference herein either prior to retrieval from the output device or after transfer to, for example, a second system or device. 
         [0029]    Operation of the programmable processing device  32  may be partially controlled by input from a user on a user input port  34  that may connect to a user interface panel on the medical device, such as a keypad. An exemplary user interface panel  106  is illustrated as part of an automation device (that may be a programmable processing device) shown in FIG. 4 of U.S. application Ser. No. 10/316,127. In another embodiment, the user input port  34  may comprise an infrared (IR) port that communicates with a remote device such as a programmable digital assistant (PDA). In yet another embodiment, the user input port  34  may comprise one of a wired or wireless interface to an external keypad. Other embodiments of the user input port  34  may comprise a barcode reader, a magnetic strip reader, or a receptacle for a flash card. 
         [0030]    The illustrated embodiment of  FIG. 1  further comprises a miscellaneous port  40  that may comprise, as examples, a barcode reader, keypad, wireless remote keypad, magnetic strip, or flash card receptacle. According to an exemplary mode of operation, patient data may be entered on the miscellaneous port  40 . For example, a patient may wear a wristband having medical information placed thereon in the form of a barcode that enters the miscellaneous port  40  through a barcode reader. In other embodiments, patient information may be coded on a flash card or on a magnetic strip that likewise may be entered into the miscellaneous port  40 . The barcode with patient information can be printed on a printer associated with the device and can be manually placed on the output device  30  to ensure delivery of an autologous concentration of material from the device, e.g., autologous regenerative cells. 
         [0031]    The programmable processing device  32  may further include a display port  38  capable of communicating with a display device such as a printer or a screen that may be implemented as part of a user interface panel  106  as illustrated, for example, in FIG. 4 of the aforementioned U.S. application Ser. No. 10/316,127. The display port  38  can be used to communicate information regarding managing and servicing the medical device to the user. 
         [0032]    An exemplary embodiment of the programmable processing device  32  is shown in  FIG. 2 . As illustrated, this embodiment comprises a processor  54  capable of executing instruction sequences. The programmable processing device  32  further comprises working memory  56 , permanent memory  60  that stores instruction sequences, a user input interface  82 , a chamber assembly interface  86 , and a concentration device interface  88 . The aforementioned elements can be interconnected by a system bus  80 , which enables the processor  54  to communicate with the elements. 
         [0033]    This illustrated embodiment of the programmable processing device  32  further comprises a chamber assembly control instruction sequence  64  and a concentration device control instruction sequence  66  that may be stored in permanent memory  60 . The processor  54  is able to execute the chamber assembly control and concentration device control instruction sequences  64  and  66 , and may thereby control the chamber assembly  22  ( FIG. 1 ) and the concentration device  28  ( FIG. 1 ) by communicating with the chamber assembly interface  86  and the concentration device interface  88  over the system bus  80 . The chamber assembly interface  86  is able to communicate with the chamber assembly  22  by means of control and communication path  24  (see also  FIG. 1 ). Likewise, with further reference to  FIG. 1 , the concentration device interface  88  is able to communicate with the concentration device  28  by means of control and communication path  27 . 
         [0034]    The embodiment illustrated in  FIG. 2  further may comprise a network interface  84 , which is capable of communicating with the processor  54  through the system bus  80  and further capable of communicating with an external network over communication path  36 . An embodiment of the network interface  84  can comprise a wired interface that may connect, for example, to a network comprising a remote server. Another embodiment of the network interface  84  may comprise a wireless interface having similar capabilities. A modified embodiment may employ a serial interface in addition to or instead of the network interface  84 . The serial interface, for example, a Universal Serial Bus (USB) interface, may be capable of communicating with an external device such as a printer. According to yet another embodiment, the programmable processing device can further comprise a display interface  90  capable of communicating with a display device such as a printer or a screen through a display port  38 . The programmable processing device  32  further may comprise a miscellaneous interface  92  capable of receiving input from, for example, at least one of a barcode reader, keypad, wireless remote, magnetic strip, or flash card reader. 
         [0035]    The permanent memory  60  of the embodiment illustrated in  FIG. 2  may have stored therein a system check instruction sequence  68 . As an example, the system check instruction sequence  68  may be included in exemplary pre-programmed steps illustrated in  FIG. 15B  of U.S. application Ser. No. 10/884,638. 
         [0036]    Typically, in accordance with embodiments of the present invention, the system check instruction sequence  68  can be executed by the processor  54  once during a normal session of collecting and processing tissue. As such, according to an implementation of the present invention, execution of the system check instruction sequence  68  can provide a means by which a record of use, i.e., a usage event, of the medical device may be created and maintained. 
         [0037]    An embodiment of the system check instruction sequence  68  that can be employed in the present invention minimally may cause the processor to receive a charge code, or other charge or identity or use related information or indication (hereinafter “charge code”), from the user input interface  82 . The charge code, which may be received on user input port  34 , may identify the user and may be associated with, for example, an authorization code, a user rate, and the like that may be used for billing purposes. 
         [0038]    Accordingly, in certain implementations of the present invention, execution of the system check instruction sequence  68  minimally can cause the processor  54  to communicate the usage event and the charge code to the network interface  84 . The usage event may comprise information concerning, for example, the medical device used, the date, and the time of the usage. 
         [0039]    An embodiment of the system check instruction sequence  68  may comprise a billing instruction sequence  70 . The billing instruction sequence  70  minimally may cause the processor to generate a bill according to, for example, the user charge code and the usage event. In certain implementations, the billing instruction sequence  70  further minimally may cause the processor to communicate a report to the display interface  90  according to the bill, whence the report may be communicated to the display port  38  for display on a user-readable device such as a printer or screen. Yet another embodiment of the medical device may comprise a display device, for example, a monitor screen, a printer, and the like, the display device being configured to automatically display the report received by the display interface. 
         [0040]    Another embodiment of the programmable processing device  32  further may comprise nonvolatile memory  56 , for example, flash memory, in which data may be stored that is not lost when power is removed from the programmable processing device  32 . The nonvolatile memory  56  may store data such as patient information, user authorization codes, or the like. According to another embodiment, the nonvolatile memory  56  may store instruction sequences, for example, one or more of the instruction sequences shown as being stored in permanent memory  60  in the embodiment illustrated in  FIG. 2 . Nonvolatile storage of such instruction sequences is advantageously contemplated by the present invention, thereby providing a capability of modifying instruction sequences, for example, upgrading device software, on an as-needed basis. Additionally, nonvolatile memory  56  may store device license information, software patches, operating systems, and the like, allowing such system elements to be upgraded from time to time. A software modify instruction sequence  78  minimally may cause the processor  54  to perform the upgrades just described. 
         [0041]    Other embodiments of the programmable processing device  32  further may comprise a monitor instruction sequence  72 . The monitor instruction sequence  72  may cause the processor  54  to record or log notable events in nonvolatile memory  56  using a store instruction sequence  74 . Notable events may comprise a simple routine use of the medical device, consumption of a given quantity of one or more reagents, use of disposable elements, and the like. A retrieve instruction sequence  76  may cause the processor  54  to retrieve stored data from nonvolatile memory  56  in respond to a command received, for example, from the network interface  84 . 
         [0042]    Yet another embodiment of the programmable processing device  32  comprises an executive instruction sequence  62  that may be referred to as an operating system in some embodiments. The executive instruction sequence  62  may cause the processor  54  to manage the execution of, for example, at least the aforementioned instruction sequences in order to carry out functions of the medical device. 
         [0043]    A pictorial diagram of an exemplary embodiment of a medical billing device  100  is depicted in  FIG. 3 . The medical billing device  100 , as illustrated in this figure and in accordance with an aspect the present invention, comprises a server, for example, a personal or laptop computer  102 , including a storage device, for example, a hard drive (not shown). The medical billing device  100  further may comprise a printer  130  connected to the personal computer  102  with, for example, a cable  128 . The medical billing device  100  may receive information according to usage of at least one medical device. According to an embodiment, the medical billing device  100  may communicate wirelessly to receive usage information, using a wireless network interface  116 , with a medical device  104  having a wireless network interface  114  as described above. For example, the network interface  114  may comprise a network interface  84  of a medical device as described in  FIGS. 1 and 2 . Operation of the medical device  104  may require the use of disposable elements symbolically represented in  FIG. 3  by disposables  110 . Exemplary embodiments of disposables  110  may comprise a smart chip  112  capable of communicating with a programmable processing device similar to programmable processing device  32  described above with reference to  FIGS. 1 and 2 . The smart chip or chips  112  may have encoded therein information such as, for example, a lot number and an expiration date for the (e.g., for each of the) disposable or disposables  110 . 
         [0044]    According to another example, the medical billing device  100  may receive usage information by means of a wired network interface  118  that is coupled to another medical device  106  having a wired network interface as likewise already described. According to yet another example, the medical billing device  100  may receive usage information from a flash memory card  122  that is manually movable from a slot  120  in a medical device  108  to a slot  124  in the medical billing device  100 . As a variation on the flash memory card example, an authorization code may be written on the flash memory card  122  by the medical billing device  100 . The medical device  108  may in certain implementations be configured to require the presence of a flash memory card  122  in slot  120 , and in other implementations further to require that the flash memory card  122  have written thereon a valid authorization code, in order for the medical device  108  to be operable. Another embodiment of the medical device  108  may comprise a barcode reader  126  capable of reading, as examples, data from a patient wrist band, user identification information from an identity badge of a user, and so on. 
         [0045]    The medical billing device  100  may maintain a database of information pertaining to, for example, medical devices, charge codes and usage events, on the storage device included in the personal computer  102 . Alternatively, part or all of the database, databases, or related information, may be maintained on an external storage medium such as a flash memory card  122 . 
         [0046]    Referring to  FIG. 4 , a typical database maintained by, for example, the medical billing device  100 , may comprise a user rate table  150 . The user rate table  150  may in turn comprise records including a medical device identification field  152 , which may contain a medical device identification code, a charge code field  154  and a rate field  156  associated with, for example, a medical device according to, for example, the medical device identification code and a charge code that may occupy the charge code field  154 . For example, an entry in the medical device identification field  152  may correspond to one or more of the medical devices  104 ,  106  and  108  depicted in  FIG. 3 . The charge code field  154  may comprise identification information for a user such as a physician, a group of users such as a collection of physicians or technicians, an organization such as a hospital or clinic, and the like. Each of these entities may have negotiated with an owner or distributor of various medical devices, for example, at least one of the medical devices illustrated in  FIG. 3 , a different rate or protocol to be maintained in a rate field  156  according to, for example, the charge code associated with the user. 
         [0047]    The medical billing device  100  may receive information from time to time according to usage of one or more medical devices associated with the medical billing device  100 . For example, the medical billing device  100  may receive information on the wireless network interface  116  comprising a usage event for the medical device  104  (i.e. an indication that medical device  104  has been used) and a charge code according to the user of the medical device  104 . 
         [0048]    Turning to  FIG. 5 , a usage table  160 , which is stored, for example, within the medical billing device  100 , may comprise a medical device identification field  162  and a charge code field  164 , and may further comprise records containing date, time, and charge information. A given record in the illustrated example of usage table  160  can be keyed, for example, to a given medical device (e.g., medical device  104 ) and a given charge code, so that the record can be updated according to pertinent received information. 
         [0049]    When usage event information is received, the medical billing device  100  may determine and assign a date and time using methods known in the art. Alternatively, the usage event may include the date and time. The medical billing device  100  may create a record (e.g., in a pertinent usage table  160 ) and may enter the date into a date field  166  of the record and may enter the time into a time field  168  of the record. The medical billing device  100  further may access user rate table  150  ( FIG. 4 ) to determine a rate according to the charge code in the charge code field  164  and the medical device identification in the medical device identification field  162 , and may enter the rate in the charge field  170  of the record. Thus, in the exemplary embodiment, usage table  160  can store information according to the usage of a single medical device by a user associated with a single charge code. In practice, several usage tables similar to usage table  160  may be maintained in the database of (or accessible by) the medical billing device  100 , which may service several medical devices and several users. 
         [0050]    As another example, the medical billing device  100  may receive information concerning a usage event associated with another medical device, such as medical device  106 , the information being received over a wired network connection  118 . In another embodiment, usage event information pertaining to yet another medical device, such as medical device  108 , can be received from a flash memory card  122  that may be manually transferred from slot  120  in medical device  108  to slot  124  in the medical billing device  100 . In these and other instances the medical billing device  100  is able to store or update information in the database according to the received information in a manner similar to that already described. 
         [0051]    In yet another example, the medical billing device  100  may receive information regarding remotely located medical devices by means of a network  134 . The network  134  may comprise, for example, the Internet, and remotely located medical devices (and/or parts or all of the database) may be located hundreds or thousands of miles away from the medical billing device  100 . For instance, the other medical devices may be located in a hospital  136  or a laboratory  138  physically separated from medical billing device  100 . In the embodiment illustrated in  FIG. 3 , medical billing device  102  connects to the network  134  through wired or wireless connection  132 . Similarly, the hospital  136  and the laboratory  138  connect with the network  134 , respectively, through wired or wireless connections  135  and  137 . Information in the database may be updated in such instances using procedures already described. 
         [0052]    The medical billing device  100  may, in other embodiments, function as a server or as a peer to peer element capable of communicating with other medical devices as well as medical devices  104 ,  106 , and  108  illustrated in  FIG. 3 . Medical billing device  100  and other medical devices may cooperate to share information over the network  134 , permitting the medical billing device  100  to gather, analyze and present real-time usage data from any desired medical device or devices. The usage data obtained may be useful in marketing medical devices and services, making financial decisions, performing clinical studies, engaging in biomedical research and development, and the like. In some instances the usage data may be sold to a third party. 
         [0053]    From time to time, the medical billing device  100  may create a report comprising a bill to be submitted to a user, the bill detailing charges for use of one or more medical devices during a given time period. According to one example, the medical billing device prints a report  132  ( FIG. 3 ) on the printer  130  whenever, for example, a predetermined time elapses or information about a usage event is received.  FIG. 6  presents a chart elucidating such a report, which may comprise a form  180 , according to a single use of a medical device. The form  180  may in turn comprise a medical device identification field  182  containing medical device identification information, a charge code field  184  containing identification of a user, and fields for date  186 , time  188 , and amount billed  190 . To create the report  132 , the medical billing device  100  may access the database, retrieve information from a table similar to usage table  160  shown in  FIG. 5 , format the information according to the form illustrated in  FIG. 6 , and print the report. 
         [0054]    According to one method of operation, the medical billing device  100  may generate billing reports on a periodic basis, such as, for example, daily, weekly, biweekly, monthly, and the like.  FIG. 7  is a chart illustrating an exemplary report, which corresponds generally to report  132  ( FIG. 3 ) and which comprises a bill  200  that may be created periodically according to uses of one or more medical devices. To create the bill  200 , the medical billing device  100  may access one or more usage tables  160  ( FIG. 5 ) in the database and may retrieve records according to usage of medical devices according to one or more charge codes during a selected time period. The bill  200  then may be created by entering the charge code or codes into a charge code field or fields  202 . Further, referring to  FIG. 5  as an example, information from the date field  166 , the time field  168 , the medical device identification field  162 , and the charge field  170  may be copied into, respectively, a date field  204 , a time field  206 , a device identification (ID) field  208 , and an amount field  210  of, for example, a line of the bill  200 . The bill  200  further may include a running balance field  212  in which amounts from the amount field  210  are accumulated, and a total billed amount may be presented in an amount due field  214 . 
         [0055]      FIG. 8  is a flow diagram summarizing an implementation of a method of billing a user for use of one or more medical devices. This implementation comprises maintaining a database of medical devices, user charge codes, and usage events at step  220 . The database may be maintained on a storage device in a laptop computer, a personal computer, a server, or the like. The database may include tables containing information similar to that depicted in the user rate table  150  shown in  FIG. 4  and usage tables similar to usage table  160  illustrated in  FIG. 5 . A medical device ID, usage event, and user charge code are received at step  222 . Various techniques are available for receiving the usage event and associated information. For example, information relating to medical device usage may be received by way of a wired or wireless network connection. In another embodiment, the information may be received on a flash memory card that is manually transferred from a medical device to a medical billing device. According to other embodiments, medical devices may have located thereon or nearby timesheets filled out by operators at times when the medical devices are used. Information from these timesheets may be collected periodically, for example, hourly, daily, or the like, and entered automatically or manually into a medical billing device such as a laptop or personal computer as illustrated in  FIG. 3 . In modified embodiments, such as may be employed in, for example, a small laboratory, the use of a medical device ID and a user charge code may be obviated. In one such modified embodiment, only a usage event may be received at step  222 . 
         [0056]    A billed amount per usage event is determined at step  224  according to, for example, the medical device ID and the user charge code received at step  222 . According to a representative implementation, the billed amount is determined according to information stored as to the medical device used and the charge code associated with the user of the medical device. A report according to the billed amount is generated at step  226 . An implementation of the method can generate a report comprising a bill when, for example, a usage event is received. Another implementation of the method can retrieve stored information pertaining to all medical device usage events by a user associated with a charge code during a selected time period, and a report can be generated according to the total charge accumulated during that time period. A display device, such as a computer monitor, printer, and the like, may display the generated report. 
         [0057]    The medical billing device  100  illustrated in  FIG. 3  typically comprises at least one processor capable of executing instructions. According to an embodiment, the medical billing device  100  may have stored in computer readable memory, exemplary contents of which are depicted in  FIG. 9 , instruction sequences  240  comprising a router instruction sequence  242  that minimally may cause the processor to communicate with medical devices, e.g. medical devices  104 ,  106 , and  108 , located on a local area network (LAN) and to facilitate communication between designated medical devices connected directly to the network  134  or connected to network  134  through a LAN, wide-area network (WAN), metropolitan area network (MAN), or the like. The instruction sequences  240  further may comprise a poling routine  244  capable of minimally causing the processor to transmit a request to any or all of the aforementioned medical devices for the purpose of retrieving stored information such as usage data as already described. The instruction sequences  240  further may comprise an analysis routine  246  capable of causing the processor to process, e.g., aggregate, organize, and classify, usage data, placing the usage data in a form capable of being readily interpreted by a human observer. A display routine  248 , likewise included in the instruction sequences  240 , may cause the processor to present the processed usage data on a display device. 
         [0058]    The intercommunication capabilities provided by network  134  may permit medical billing device  100  to perform an inventory control function using an inventory control instruction sequence  250  that may be one of the instruction sequences  240 . The inventory control instruction sequence  250  may cause the processor to execute an alert handler instruction sequence  252 , thereby causing the processor to respond to messages received from medical devices, the messages pertaining, for example, to consumption of disposables and reagents. The inventory control instruction sequence  250  may, in those cases, cause the processor to estimate a need for disposables and reagents, place an order with a manufacturer or distributor  140  ( FIG. 3 ), and/or execute a billing routine  254  that may cause generation of a bill to a customer according to the order. The bill may be delivered electronically, or may, in some embodiments, be printed on paper on-site with the customer, or printed centrally with the billing device  100  and mailed to the customer. Supplies may be automatically shipped to the customer by the manufacturer or distributor, obviating a need for an order to be initiated by the customer. 
         [0059]    Another embodiment of the medical billing device  100  ( FIG. 3 ) may comprise an upload handler instruction sequence  256  capable of causing the processor to receive information uploaded from one or more medical devices as described herein. The medical billing device  100  further may comprise a download handler instruction sequence  258  capable of causing the processor to receive information to be downloaded to one or more medical devices that communicate with the network  134 . For example, the downloaded information may comprise software upgrades, licenses, software patches, operating systems and the like. An eXecutable Internet may facilitate the upload/download procedures contemplated by the present invention. 
         [0060]    An example of a method of managing usage data according to a collection of medical devices is illustrated in the flow diagram presented in  FIG. 10 . Usage data is gathered at step  270  using techniques already described. For example, a polling routine  244  described above with reference to  FIG. 9  may cause a processor to request usage data from one or more medical devices having access to a network  134  as illustrated in  FIG. 3 . With usage data available, a report request may be received at step  272 . For example, an owner or seller of medical devices may enter a request for a report on a keyboard of the medical billing device  100  ( FIG. 3 ), or another authorized user may request a report from another location having access to the network  134 . Typically, the request for a report includes an indication of the type of information desired in the report. See, for example, illustrative reports as described below in  FIGS. 12 and 13 . The usage data may be analyzed at step  274 . The analysis may occur in the medical billing device  100  and may be accomplished by executing analysis routine  246  as described above with reference to  FIG. 9 . According to the report request and the usage data, a report may be generated at step  276 . The report may comprise a graphical presentation in some cases (see, for example,  FIG. 13 ). In other cases, the report may be presented in tabular form as shown in  FIG. 12 . In either case, the report may be disseminated at step  278 . 
         [0061]    A variety of reports may be generated according to the method described in  FIG. 10 . For example, information may be received according to a number of hours of operation of a given medical device since the medical device was initially placed into service. The received information may take the form of usage events as described herein. Alternatively, referring to records maintained in the medical billing device  100 , a number of hours of operation of the medical device since routine maintenance or operation was last performed on the medical device may be determined. By comparing such numbers of hours with historical data regarding the operation of similar medical devices, repair personnel can be dispatched remotely to perform maintenance on the medical device, while likelihood of device malfunction is low, in time to prevent loss of revenue due to unscheduled downtime for repairs or failure of the medical device. Service costs can be minimized as a result of repair personnel being sent out with the right parts a first time, and only when needed. 
         [0062]    In other instances, the report request received at step  272  ( FIG. 10 ) may comprise an alert from a medical device, letting a user and/or a manufacturer or distributor know when there is a problem with the medical device or, for example, when reagents or disposables are running low. 
         [0063]    Some users of medical devices may choose to use disposables manufactured by a third party, rather than disposables manufactured by a manufacturer of the medical devices. Using intelligent methods as described herein, a medical device may be capable of recognizing such events and of generating an alert that can be received by the medical billing device  100  ( FIG. 3 ). According to an embodiment of the present invention, user fees may be adjusted upward when third-party disposables are used, thereby reducing an incentive for users to deviate from recommended practices. 
         [0064]    According to another embodiment, medical devices interconnected as described herein are required to communicate with, e.g., the medical billing device  100  ( FIG. 3 ) from time to time. If a given medical device fails to communicate with the medical billing device  100  for longer than a prescribed time interval, e.g. one hour, then the medical device may be presumed to be stolen and/or cease to function in whole or in part. 
         [0065]    Other reports generated by the method described in  FIG. 10  may comprise historical data regarding, for example, usage of a class of medical devices by all or a subpopulation of users. This historical data may be made available (e.g., for a fee) to users and/or prospective users so that, for example, physicians can optimize usage parameters according to patient profiles or to assess risks. 
         [0066]      FIG. 11  is a flow diagram illustrating another example of how usage data may be managed according to the present invention. A facility is first selected at step  290 . The facility may comprise a hospital  136  ( FIG. 3 ), a laboratory  138 , or other facility having access to network  134 . Usage data may be requested at step  292 , for example, by causing a processor in medical billing device  100  to execute a polling routine  244  as described above with reference to  FIG. 9 . When usage data is received, inventory may be estimated at step  294 . An inventory control instruction sequence  250  may cause a processor in the medical billing device  100  ( FIG. 3 ) to estimate inventory in the selected facility, taking into account, for example, all relevant medical devices that are in use at that facility. According to the estimated inventory, a manufacturing order may be generated at step  296 . The manufacturing order may be generated by the processor in the medical billing device  100  (cf.  FIG. 3 ) according to the inventory control instruction sequence  250  ( FIG. 9 ). The manufacturing order may be communicated to the network  134  through connection  132  and received from the network  134  by a distributor  140  ( FIG. 3 ) through connection  139 . The distributor  140  then may fill the order, shipping products directly to the selected facility. A bill may be generated at step  298  in accordance with supplies requested in the manufacturing order at step  296 , and the bill may be delivered to the facility at step  300 . According to a typical embodiment, the bill can be communicated electronically through the network  134  as described herein. 
         [0067]      FIG. 12  is a chart illustrating an example of a tabular report of financial aspects of operation of one or more medical devices. The report shown comprises a table  310  having a field  312  for a year of operation, e.g. CY  2003 , FY  2004 , or the like. A month field  314  may identify twelve months in each of twelve rows in the table  310 . A number of patients field  316  may contain a number of patients treated with the one or more medical devices during each month listed. The number of patients information may be received as described herein by polling medical devices able to communicate with the network  134  ( FIG. 3 ). A revenue field  318  may contain revenue generated by the medical devices during each month. Similarly, a disposables cost field  320  and a reagent cost field  322  may comprise costs of, respectively, disposables and reagents during each month, the disposables and reagents costs likewise being received by, for example, polling the medical devices. An analysis routine  246  ( FIG. 9 ) may cause a processor in medical device  100  to calculate a gross profit  324  (revenue minus disposables cost minus reagent cost) for the collection of medical devices for each month listed in the table  310 . 
         [0068]    Information presented in table  310  of  FIG. 12  may alternatively be presented graphically as depicted in  FIG. 13 . In the illustrated example, disposables cost (gray), reagent cost (cross hatched) and gross profit (white) are presented in a stacked bar-graph  330 , whereby the height of each bar represents total revenue  338  received from operation of medical devices during each of twelve months 336 in CY  2004   334 . 
         [0069]    As disclosed in U.S. Application No. 60/338,856 with reference to  FIG. 4 , an embodiment of a medical device may have integrated therein a printer component comprising a hardware printer and software driver. Alternatively, the device may comprise a software printer driver and an external interface, for example, a USB interface, capable of communicating with an external printer. Another embodiment of a medical device further may include a storage device, for example, flash memory, and permanent memory having stored therein instruction sequences capable of causing a processor to provide billing functions. The embodiment thereby may provide billing functions pertaining to or following the method described in  FIG. 8  in accordance with, for example, the particular medical device. For instance, a table similar to that illustrated in  FIG. 4  may be stored in flash memory, and the medical device may cause printing of a report that is similar to that described in connection with  FIG. 6  after each use of the medical device or periodically as described herein. 
         [0070]    In view of the foregoing, it will be understood by those skilled in the art that the methods of the present invention can facilitate monitoring, managing and servicing medical devices, and in particular billing for use of medical devices for separating and concentrating clinically safe regenerative cells from adipose tissue. The above-described embodiments have been provided by way of example, and the present invention is not limited to these examples. Multiple variations and modification to the disclosed embodiments will occur, to the extent not mutually exclusive, to those skilled in the art upon consideration of the foregoing description. Additionally, other combinations, omissions, substitutions and modifications will be apparent to the skilled artisan in view of the disclosure herein. Accordingly, the present invention is not intended to be limited by the disclosed embodiments, but is to be defined by reference to the appended claims.