PRIORITY INFORMATION This application is a continuation of application Ser. No. 10/868,662, filed Jun. 15, 2004, pending, which is a continuation of application Ser. No. 10/097,552, filed Mar. 12, 2002, now U.S. Pat. No. 6,749,586, which is a continuation of application Ser. No.09/626,571, filed Jul. 27, 2000, now U.S. Pat. No. 6,355,018, which is a continuation of application Ser. No. 09/251,021, filed Feb. 16, 1999, now U.S. Pat. No. 6,228,057, which is a continuation of application Ser. No. 08/658,689, filed Jun. 5, 1996, now U.S. Pat. No. 5,871,465, which is a continuation of application Ser. No. 08/344,973, filed Nov. 25, 1994, now U.S. Pat. No. 5,573,506. The entireties of these applications are incorporated by reference herein and made a part of the present disclosure.
BACKGROUND OF THE INVENTION 1. Field of the Invention
The present invention relates to a remotely programmable infusion system for medical applications. More particularly, the present invention relates to an infusion system for delivering a variety of medicines and fluids that sends voice commands and queries to a remote touch-tone transceiver and that can be programmed by pressing keys on the keypad of the remote touch-tone transceiver in response to the commands and queries.
2. Description of the Related Art
Infusion devices are used in the medical field to administer and deliver medicines and other fluids to a patient. Today, due in part to rising health costs and the high cost of hospital rooms, and in part to the desire to provide comfort and convenience to patients, the medical industry has promoted in-home care for patients suffering from various maladies. Particularly, many patients require delivery and administration of medicines or other IV fluids on a regular basis. Delivery and administration is accomplished via a variety of infusion devices, such IV pumps and gravity pumps and other types of IV administration. By supplying patients with infusion devices that are lightweight and easy to use, the patients can receive their medicinal needs at home, i.e., without having to be at a hospital and without direct assistance by a care provider, such as a nurse.
Nevertheless, the operating parameters of infusion devices must frequently be changed, due to variations in the patient's needs. Therapy changes may also require that entire protocols be programmed. In early versions of home infusion devices, the physical presence of a care provider at the infusion device was required to reprogram the device's protocol. Such reprogramming was costly and time-consuming, thereby severely limiting the efficiency and convenience of infusion devices.
Since the introduction of these early home infusion devices, the medical industry has made advances in the techniques by which a home infusion device can be monitored and reprogrammed. For example, one system employs a patient activated switch on a diagnostic apparatus that causes automatic dialing of a telephone number corresponding to a care provider remote from the diagnostic apparatus. This enables the patient to communicate with the care provider through a speaker and microphone on the diagnostic apparatus, permitting interactive communication with the care provider regarding the routines to be performed by the diagnostic apparatus. This system, however, merely provides the capability for the care provider to monitor the infusion device, but does not offer the capacity to remotely reprogram the infusion device.
Another remote monitoring system employs a user interface for programming blood pressure testing protocol into, and downloading blood pressure data from, ambulatory blood pressure monitoring units. The user interface is connected to a central processing computer via a telephone line. Control units located at the blood pressure testing site transfer blood pressure data to the central computer, which generates comprehensive medical reports for specific patients, but which cannot transmit reprogramming signals back to the control unit.
Other systems employ remote computers for monitoring and reprogramming the protocol of the infusion device. In one such system, the infusion device has a delivery unit for delivering the medicinal solution and a removable logic unit for controlling operation of the delivery unit. The logic unit is either attached to or separate from the delivery unit, and the latter can be worn by the patient. The logic unit is connected to a programming computer via a telephone line. The computer can be used to program the logic unit with a logic configuration suitable for operating the delivery unit in accordance with the intended delivery requirements. Thus, while such systems provide for remote reprogramming of the protocol, they require a remotely located computer to accomplish reprogramming.
The previous conventional systems have a variety of drawbacks. Most importantly, they do not provide simple, interactive reprogramming by a care provider without the need for a remote reprogramming computer. The ability to have the care provider access the remotely located infusion device on a standard telephone and reprogram the infusion device via the keys on the telephone keypad is a significant advance over conventional reprogramming techniques. This is because touch-tone reprogramming is less costly, quicker, and much more convenient for both the care provider and the patient, making infusion devices easier to use and more versatile. Conventional home infusion systems also do not have the capacity to send recorded voice signals to the remote care provider instructing and asking the care provider about reprogramming the infusion device. By using recorded voice commands and queries stored in the infusion system that direct the care provider in reprogramming the infusion device, the process of reprogramming is made simpler and more efficient, with little chance of making programming errors. Therefore, a need exists for an infusion device that can be remotely programmed via a transceiver without the need for a remote programming computer and that sends recorded voice signals from the infusion device to a care provider.
SUMMARY OF THE INVENTION Accordingly, the present invention is directed to a remotely programmable infusion system and a method for remotely programming an infusion system via a remote transceiver that substantially obviates one or more of the problems due to limitations and disadvantages of the related art.
Additional features and advantages of the invention will be set forth in the description that follows and in part will be apparent from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the apparatus and method particularly pointed out in the written description and claims of this application, as well as the appended drawings.
To achieve these and other advantages, and in accordance with the purpose of the invention as embodied and broadly described herein, the present invention defines a remotely programmable infusion system having a programmable protocol, the infusion system being remotely programmable by a remote touch-tone transceiver. The remotely programmable infusion system comprises a memory for storing a programmable protocol and a remote communication port for sending a voice signal to the remote touch-tone transceiver and for receiving a remote programming signal from the remote touch-tone transceiver. The remotely programmable infusion system also comprises a voice storage unit for storing the voice signal and a processor, coupled to the remote communication port and to the voice storage unit and to the memory, for accessing the voice signal from the voice storage unit and the programmable protocol from the memory, and for processing the programmable protocol in response to receiving the remote programming signal.
In another aspect, the present invention defines a method for remotely programming an infusion system. The infusion system has a voice storage unit for storing a voice signal and has a programmable protocol and is remotely programmable by a remote touch-tone transceiver. The method comprises several steps: establishing a connection between the infusion system and the remote touch-tone transceiver; accessing the voice signal from the voice storage unit in response to establishing the connection; sending the voice signal to the remote touch-tone transceiver; receiving a remote programming signal from the remote touch-tone transceiver; and processing the programmable protocol in response to receiving the remote programming signal.
In a further aspect, the present invention comprises a remotely programmable infusion system having a programmable protocol stored in a protocol memory, the remotely programmable infusion system being programmable by a remote touch-tone transceiver. The infusion system comprises an infusion pump for delivering fluids to a patient. The infusion pump has an infusion data port. The infusion system also comprises a homebase unit, coupled to the infusion communication port on the infusion pump via a homebase data port, for processing the programmable protocol. The homebase unit comprises a voice storage unit for storing a voice signal and a remote communication port for sending the voice signal to the remote touch-tone transceiver and for receiving a dual-tone multi-frequency (DTMF) signal from the remote touch-tone transceiver. The homebase unit further comprises a processor, coupled to the remote communication port, to the voice storage unit, and to the protocol memory, for accessing the voice signal from the voice storage unit, for accessing the programmable protocol from the protocol memory, and for processing the programmable protocol to obtain a processed programmable protocol in response to the DTMF signal. The processed programmable protocol is relayed from the processor to the infusion pump via the homebase data port and the infusion data port.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, to illustrate the embodiments of the invention, and, together with the description, to explain the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a diagrammatical representation of the programmable infusion system of the present invention.
FIG. 2 is a block diagram of the homebase unit in accordance with the present invention.
FIG. 3 is a flow diagram illustrating entry of an access code and the main menu in an example of the present invention.
FIG. 4 is a flow diagram illustrating an access code menu in accordance with an example of the present invention.
FIG. 5 is a flow diagram illustrating a review mode menu in accordance with an example of the present invention.
FIG. 6 is a flow diagram illustrating an edit mode menu in accordance with an example of the present invention.
FIG. 7 is a flow diagram illustrating sub-menus of the edit mode menu in accordance with an example of the present invention.
FIGS. 8A and 8B represent a flow diagram illustrating a programming mode menu in accordance with an example of the present invention.
FIG. 9 is a flow diagram illustrating sub-menus of the programming mode menu in accordance with an example of the present invention.
FIG. 10 is a table illustrating the alarm functions that can be employed in the system of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Reference will now be made in detail to the present preferred embodiment of the invention, an example of which is illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
In accordance with the present invention, a remotely programmable infusion system is provided that allows remote programming of the infusion system from a remotely located transceiver, such as a push-button telephone. The remotely programmable infusion system includes a memory and a voice storage unit. The infusion system also includes a remote communication port, as well as a processor that is coupled to the remote communication port, the voice storage unit, and the memory. It should be understood herein that the terms “programming,” “programmable,” and “processing” are generalized terms that refer to a host of operations, functions, and data manipulation. Those terms, therefore, are not to limited herein to editing and deleting data, parameters, protocol, and codes. For example, programming and processing, as used herein, may encompass editing, changing, erasing, entering, re-entering, viewing, reviewing, locking, and inserting functions.
An exemplary embodiment of the apparatus of the present invention is shown inFIG. 1 and is designated generally byreference numeral10. As herein embodied and shown inFIG. 1, the remotelyprogrammable infusion system10 includes apump unit12 and ahomebase14. Thepump unit12 and homebase14 may be two separate units, as illustrated inFIG. 1, or may comprise a single integral unit housing both thepump12 and thehomebase14. With both elements integrated into a single infusion device, the device may be entirely portable and programmable, both via local and remote programming devices.
Thepump unit12 includes ahousing16 that contains the electrical and mechanical elements of thepump unit12. An example of apump unit12 that can be used in the present invention is disclosed in U.S. Pat. No. 5,078,683, assigned to the assignee of the present invention. Thepump unit12 also includes aninfusion line18 that is connected to a patient atend19. Thepump unit12 further includes adisplay20 andvarious controls22.
Thehomebase14 includes acradle24 for holding thepump unit12, a cable for connecting thehomebase14 to thepump unit12, controls26 for controlling operation of thehomebase14, display lights28 for indicating various conditions of thehomebase14, and aninternal audio device29 for providing audio alarm signals. As embodied herein, thecontrols26 include alink button30, alocal button32, and asend button34. The display lights28 include await light36, aphone light38, and analarm light40. The function of thecontrols26 and the display lights28 will be described in detail below. Thehomebase14 also includes aremote communication port42 and alocal communication port44. Preferably, thehomebase14 and pump12 are interconnected by an infra-red communications link46,48.
As embodied herein, theremote communication port42 and thelocal communication port44 each comprise a standard modem, as is well known in the art. Preferably, the modem module of the present invention is a Cermetek modem No. CH1785 or CH1782. These modem modules may operate at 2400 baud or other baud rates. Other baud rates, however, can also be employed in the present invention. Thelocal button32 is used to activate thelocal communication port44. For example, when the care provider is at the premises where theinfusion system10 is located, the care provider presses thelocal button32, thereby activating thelocal communication port44. The care provider can then communicate with thehomebase14 via a local telephone (not shown) at the premises that is connected to thelocal communication port44. If, on the other hand, the care provider is at a location remote from theinfusion system10, thelink button30 is pressed, activating theremote communication port42. In this way, the care provider can communicate with thehomebase14 via a telephone (or other such transceiver) located at the remote location.
For convenience, this description refers to local and remote telephones, but it should be understood that any touch-tone or DTMF transceiver can be employed in the present invention, or for that matter, any transceiver that is capable of two-way communication and activation or selection of programming parameters both independently of and in response to various prompts and queries. It should also be understood that the term “touch-tone transceiver” is not limited to conventional push-button telephones having a 12 key keypad, with 0-9, “*”, and “#” keys. Rather, as defined herein, the term “touch-tone transceiver” refers to any transceiver capable of generating signals via a keyboard or other data entry system and thus is not limited to transceivers that generate DTMF signals, such as conventional telephones. Examples of “touch-tone transceivers” as defined herein include conventional push-button telephones, computers having a keyboard and/or mouse, transmitters that convert human voice to pulse or digital or analog signals, and pager transceivers.
Thehomebase data port46 andpump data port48 comprise a wireless emitter/detector pair. Preferably,data ports46,48 each comprise and infra-red emitter/detector, permitting wireless communication between thepump unit12 and thehomebase14. Other wireless communications ports may be employed, however, or thepump unit12 and thehomebase14 may have theirdata ports46,48 hard-wired together. As described above, moreover, thepump unit12 and thehomebase14 may comprise a single unit, obviating the need for a wireless or hard-wired link between the two units. Apower cable50 is preferably employed to provide power to thepump unit12 via thehomebase14. Alternatively, thepump unit12 may have its own power cable coupled directly to the power source, as opposed to being connected through thehomebase14.
With reference toFIG. 2, the elements included in thehomebase14 will be described. Thehomebase14 comprises theremote communication port42, thelocal communication port44, aprotocol memory51, avoice storage unit52, aprocessor53, avoice synthesizer49, and anaccess code memory54. Theprotocol memory51, thevoice storage unit52, and theaccess code memory54 can all be contained in the same memory device (such as a random-access memory), or in separate memory units. Preferably, thevoice storage unit52 comprises a read-only memory (ROM), and theprocessor53 comprises an8-bit microcontroller, such as theMotorola MC68HC1 1 AOFN. Thehomebase14 also includes thedata port48 for relaying information between the homebase14 andpump unit12. Thevoice synthesizer49 is preferably an integrated circuit that converts digitized voice signals to a signal that emulates the sound of a human voice. As embodied herein, thevoice synthesizer49 need only be used to convert the signals outgoing from thehomebase14 to the remote or local telephone and thus is not required for converting incoming signals from the remote or local telephone. The voice synthesizer may comprise an LSI speech synthesis chip commercially available from Oki, part number MSM6585.
Theremote communication port42, thelocal communication port44, and thehomebase data port48 are all coupled to theprocessor53 viadata buses55a,56a,57a, respectively. Thecommunication ports42,44 receive signals from a transceiver (such as a telephone) and relay those signals over thebuses55a,56a, respectively, to theprocessor53, which in turn processes the signals, performing various operations in response to those signals. Theprocessor53 receives digitized voice signals from thevoice storage unit52 via bus59aand sends those digitized voice signals to thevoice synthesizer49 viabus59b, where the signals are converted human voice emulating signals. Those human voice signals are sent from thevoice synthesizer49 viabuses55b,56b,57btobuses55a,56a,57a, which in turn relay the those signals to theremote communication port42, thelocal communication port44, and thehomebase data port48, respectively.
For example, suppose it is necessary to provide instructions to the care provider operating the remote telephone (not shown). Theprocessor53 sends a voice address signal over a data bus59acoupling theprocessor53 to thevoice storage unit52. The voice address signal corresponds to a location in thevoice storage unit52 containing a particular voice signal that is to be sent to the remote transceiver. Upon receiving the voice address signal, the particular voice signal is accessed from thevoice storage unit52 and sent, via the data bus59a, to theprocessor53. Theprocessor53 then relays the voice signal via thedata bus59bto thevoice synthesizer49, which converts the voice signal and sends the converted signal viadata buses55band55ato theremote communication port42, which sends the converted signal to the remote transceiver. The voice signal retrieved from thevoice storage unit52 may be a digitized representation of a person's voice or a computer generated voice signal (both being well known in the art). The digitized voice signal is converted by thevoice synthesizer49 to a signal that emulates the sound of a human voice. The voice signal instructs the care provider on how to respond to the voice signal and what type of information the care provider should send. As the remote transceiver may be a push-button telephone having a keypad with multiple keys, the care provider then presses the appropriate key or keys, thereby sending a DTMF signal back to theremote communication port42 of thehomebase14. It should be understood, however, that the remote transceiver need not be a push-button telephone, but rather any transceiver capable of sending and receiving DTMF or other similar signals. For example, the remote transceiver may be a computer or portable remote controller.
Suppose the DTMF signal sent by the care provider is a remote programming signal, which is transmitted from the remote telephone to theremote communication port42 of thehomebase14. Theremote communication port42 then relays the remote programming signal via thedata bus55ato theprocessor53. In response to receiving the remote programming signal, theprocessor53 accesses a particular parameter of the programming protocol from theprotocol memory51. To access the parameter, theprocessor53 transmits a protocol address signal over thedata bus58 that couples theprocessor53 and theprotocol memory51. The protocol address signal corresponds to a location in theprotocol memory51 containing the parameter. The parameter is then sent from theprotocol memory51 to theprocessor53 over thedata bus58. Depending on the nature of the remote programming signal, theprocessor53 can then perform one of a number of operations on the parameter, including editing, erasing, or sending the parameter back to the remote transceiver for review. Those skilled in the art will recognize that many types of signals or commands can be sent from the remote transceiver to thehomebase14 for processing. Examples of such signals, how they are processed, and their effect will be described in detail below in conjunction with the description of the operation of the present invention.
In accordance with the present invention, theinfusion system10 can incorporate various security measures to protect against unwanted programming of the pump protocol. Significantly, a user access code can be used to block programming except by persons with the user access code, which may be a multi-digit number (preferably a four digit number). Theinfusion system10 can be equipped with one or multiple user access codes, which are stored in the access code memory. To initiate communication with theinfusion system10, a care provider is connected to theinfusion system10 via a remote conventional push-button telephone (not shown). This connection may be initiated by a call from the care provider to the infusion system10 (or a patient talking on a telephone located near the infusion system10), or by a call from the patient to the care provider. Either way, the care provider is connected to theinfusion system10. After the connection is made between the care provider and theinfusion system10, the care provider is asked (via a voice signal stored in the voice storage unit52) to enter the user access code. If the care provider enters a valid user access code (as explained above, there may be several valid codes), the care provider is permitted to access and/or program the pump protocol.
During a programming session, in certain circumstances (which will be described below), the user access codes can be reviewed, edited, and/or erased entirely and re-entered. To perform any of these functions, a programming signal is sent by the care provider (from, e.g., a remote push button telephone) to thehomebase14. That programming signal is relayed by theremote communication port42 to theprocessor53, which processes the signal and generates an access code address signal. The access code address signal, which corresponds to a memory location inaccess code memory54 holding a user access code, is sent over adata bus60 to theaccess code memory54. The particular user access code is then retrieved and sent back over thedata bus60 to theprocessor53, which processes the user access code in some manner.
To communicate with thepump12, the homebase is equipped with thehomebase data port48. The pump protocol can be sent from thehomebase14 to thepump12 via thehomebase data port48 and thepump data port46. Thus, for example, theprocessor53 accesses the protocol from theprotocol memory51 and sends the protocol viadata bus57ato thehomebase data port48. Thehomebase data port48 then sends the information over the infra-red link to thepump data port46, where it is processed by circuitry and/or software in thepump12. In this way, the pump protocol can be programmed (e.g., edited, redone, reviewed, locked, re-entered, etc.).
The functions of thecontrols26 of theinfusion system10 will now be described. Thelocal button32 is used to activate the local transceiver. If the care provider is located at thehomebase14, and a local transceiver (e.g., a push-button telephone) is at that location and connected to thelocal communication port44, thelocal button32 is depressed, activating thelocal communication port44 and thereby providing a communication connection between the local telephone and thehomebase14.
Thesend button34 is designed to permit sending of theinfusion system10 protocol to a remote (or local) computer (not shown). In this way, a remote or local computer can maintain a file having the protocol ofmany infusion systems10 located in various places and monitor those protocols. If the computer is remote from theinfusion system10, a person located at the homebase14 presses thesend button34, which in turn downloads the existing protocol to theremote communication port42. The protocol is then transmitted via theremote communication port42 to the remote computer.
Thelink button30 is used to initiate a remote (or local) programming session, or, in other words, to enter the remote touch-tone programming mode of theinfusion system10. When initiating a programming session, the care provider calls the telephone number corresponding to the infusion system10 (or the patient's home phone). The call may ring at a local telephone coupled to thehomebase14 via thelocal communication port44. The patient answers the call, and the care provider and patient can communicate between the remote and local telephones via standard voice signals. This is known herein as a phone mode or patient conversation mode. The care provider then instructs the patient to depress thelink button30, which disconnects the patient from the telephone line and initiates the programming mode described below with reference toFIGS. 3-9. If, however, the patient does not answer the care provider's call, the homebase may be equipped with an internal switching system that directly connects the care provider with thehomebase14 and initiates the programming mode. The internal switching may be accomplished with hardware in thehomebase14 or with software that controls theprocessor53, or with a hardware-software combination. Either way, the care provider may then begin processing the information and protocol stored in thehomebase14. (As described above, the call may be initiated by the patient to the care provider.)
The functions of the display lights28 will now be described. Preferably, the display lights28 comprise LEDs. Thewait light36 indicates when thehomebase14 is involved in a programming session or when its is downloading the protocol to the remote computer. Accordingly, thewait light36 tells the patient not to disturb thehomebase14 until thewait light36 goes off, indicating that internal processing elements of thehomebase14 are inactive. Thephone light38 indicates when the care provider and the patient are involved in voice communication via the remote telephone and the local telephone and thus when the internal processing elements of thehomebase14 are inactive. Thephone light38 may also indicate when theinfusion system10 is ready. Thealarm light40 indicates various alarm conditions and functions in theinfusion system10. The alarm conditions and operation of the alarm light in response to those conditions will be described below with reference toFIG. 10.
Illustrated inFIGS. 3-9, the programming mode or sequence of the present invention will be described in detail. As described above, when a care provider wants to access and process the protocol of the homebase14 from a remote telephone, the care provider calls a telephone number corresponding to theinfusion device10. Preferably, the call from the care provider rings at a local telephone coupled to thehomebase14. If the call is answered by the patient (or some other person) located at the local telephone andhomebase14, the care provider and patient communicate by standard voice signals between the remote and local telephones (i.e., communicate in the phone or patient conversation mode). During such communications, the care provider asks the patient to depress the link button30 (or some series of buttons) on thehomebase14, which connects the care provider withhomebase14, terminates the phone mode, and initiates a remote touch-tone programming session. If, on the other hand, the care provider's call is not answered, the care provider may be directly connected to thehomebase14, as described above, thereby directly initiating a remote touch-tone programming session without entering the phone mode. Alternatively, a touch-tone programming session can be initiated by a care provider located at the local push-button telephone simply by picking up the telephone handset and pressing thelocal button32, which gives the local telephone access to thehomebase14.
Once the care provider has accessed the programming mode of thehomebase14, a series of steps are followed to enable the care provider to program the operational protocol of theinfusion device10. It should be understood that the following programming and access steps are exemplary only and that many variations can be made to the disclosed scheme.
With reference toFIG. 3, theprocessor53 accesses from the voice storage unit52 agreeting message61, which is transmitted to the care provider at the remote or local telephone. Following thegreeting message61, a voice command62 (which is accessed by theprocessor53 from the voice storage unit52) is sent to the care provider asking the care provider to enter an access code. Using the keys on the remote push-button telephone, the care provider enters the access code, and theprocessor53 determines whether the entered access code is valid (Step63). If it is valid, theprocessor53 determines inStep64 whether it is a master access code or a user access code. If the care provider has entered a master access code, the care provider is transferred (circle65) to anaccess code menu90 illustrated inFIG. 4, which provides for programming of the master and user access codes.
If the care provider has entered a user access code, theprocessor53 accesses from the voice storage unit52 a number of voice queries comprising a main menu82: (1)Step66—asks whether the care provider wants to review the current programmable homebase protocol, instructing the care provider to depress a particular key on the touch-tone key pad to select this option; (2)Step67—asks whether the care provider wants to edit the current protocol, providing a similar instruction; (3)Step68—asks whether the care provider wants to create an entirely new protocol, with instructions on how to select this option; and (4)Step69—asks whether the care provider wants to terminate the programming session and return to voice communication with the patient. If the care provider selects the review mode (Step66), the care provider is transferred (circle70) to areview mode menu195 illustrated inFIG. 5. If the care provider selects the edit mode (Step67), the care provider is transferred (circle71) to anedit mode menu200 illustrated inFIG. 6. If the care provider selects the create mode (Step68), the care provider is transferred (circle72) to a createmode menu300 illustrated inFIG. 8A. Finally, if the care provider selects direct conversation with the patient (Step69), the connection is switched to a phone mode (Step73). In the phone mode, the care provider can talk with the patient to verify programming changes (Step74). The care provider can then hang up the remote telephone after completing the conversation with the patient (Step75).
If the care provider entered an invalid access code, the following steps are followed. In response to receiving an invalid code (see Step63), the care provider is asked (in Step63) to enter another access code because the one previously entered was invalid. If this next entered access code is valid, the care provider is transferred (via Step77) to the access code decision step (i.e., Step64), and the process is as described above. If, however, the care provider enters another invalid accesscodes decision Step77 goes to Step78, in which the care provider is told the access code is invalid and is asked to enter another access code. If this code is valid,decision Step79 transfers the care provider to accesscode decision step64.
If, on the other hand, the care provider has entered a third invalid access code,decision Step79 goes to Step80. The care provider is told inStep80 that the access code is invalid and to contact a home healthcare provider to obtain a correct access code, and thehomebase14 hangs up (Step81). It should be understood that any number of iterations of access code entering can be employed in the present invention. For example, if the care provider enters two invalid access codes, the homebase could hang up, or it could permit the care provider more than three tries to enter a proper access code.
Referring now toFIG. 4, theaccess code menu90 will be described. If the care provider has entered a master access code, the care provider is transferred to the access code menu90 (via circle65). Upon accessing this menu, thehomebase14 generates a number of voice queries that are transmitted to the care provider and provide the care provider with a number of options. First, inStep91, the care provider is asked whether a new master access code is to be entered and is instructed to press a certain button on the touch tone key pad (in this case the number “1”) to select this option. If the care provider selects this option, thehomebase14 tells the care provider to enter the existing master access code (Step92) and to enter a new master access code (Step93). The newly entered master access code is then read back to the care provider by the homebase14 (Step94), and thehomebase14 generates a voice command that tells the care provider to press the “#” key on the key pad to accept this new master access code (Step95). If the care provider presses the “#” key, thehomebase14 returns (Step96) the care provider to the access code menu90 (via circle65). Those skilled in the art will recognize that the keys to be pressed by the care provider are only exemplary and that other keys could be designated to accept and/or select various options andprogramming 5 entries.
Second, inStep97, the care provider is asked whether a new user access code is to be entered and is instructed to press a certain button on the touch tone key pad (in this case the number “2”) to select this option. If the care provider selects this option, thehomebase14 tells the care provider to enter a new user access code (Step98). If the entered new user access code already exists, the program loops around (Steps99-100) and asks the care provider to enter a new master access code again (Step97). If the newly entered user access code does not already exist, the new user access code is then read back to the care provider by the homebase14 (Step101), and thehomebase14 generates a voice command that tells the care provider to press the “#” key on the key pad to accept this new user access code (Step102). If the care provider presses the “#” key, thehomebase14 returns (Step103) the care provider to the access code menu90 (via circle65).
Third, inStep104, the care provider is asked whether he or she would like to query the user access codes and is instructed to press a certain button on the touch tone key pad (in this case the number “3”) to select this option. If the care provider selects this option, thehomebase14 tells the care provider inStep105 that there are a certain number of user access codes (depending on how many there are). InStep106, thehomebase14 recites the user access codes to the care provider and continues reciting the user access codes (Step107) until all are recited. After completing reciting the user access codes, thehomebase14 returns (Step108) the care provider to the access code menu90 (via circle6-E).
Fourth, inStep109, the care provider is asked whether he or she would like to erase the user access codes and is instructed to press a certain button on the touch tone key pad (in this case the number “4”) to select this option. If the care provider selects this option, thehomebase14 asks the care provider to select one of two options: (1) to erase specific user access codes, press a certain button on the touch-tone key pad (in this case the number “1”) (seeStep110); or (2) to erase all user access codes, press a different button (in this case the number “2”) (see Step115). If the care provider selectsStep110, the care provider is asked to enter the specific user access code to be deleted (Step111), and the homebase14 reads back that specific user access code inStep112. The homebase14 then asks the care provider to press the “#” button on the touch-tone key pad to accept deletion of that user access code (Step113) and is returned to the access code menu inStep114. If the care provider selects Step115 (global deletion), thehomebase14 warns the care provider that he or she is about to erase all the user access codes and asks for the care provider to press the “#” button to accept (Step116). The homebase then returns to the access code menu90 (Step117).
Fifth, inStep118, the care provider is asked to press a certain number (in this case “5”) to exit the access code menu. If the care provider selects this option, thehomebase14 returns (via Step119) to the access code prompt62 (seeFIG. 3).
Referring now toFIG. 5, the review mode will be described in detail. If the care provider has selected the review mode inStep66, thehomebase14 transfers (circle70) the care provider to areview mode menu195 illustrated inFIG. 5. Upon accessing this menu, thehomebase14 generates a number of voice queries that are transmitted to the care provider and provide the care provider with a number of options—namely, reviewing the following information: (1) the operating parameters of a continuous mode of the pump12 (Step120); (2) the operating parameters of an intermittent mode of the pump12 (Step121); (3) the operating parameters of a taper mode of the pump12 (Step122); (4) the operating parameters of a patient controlled analgesia (PCA) mode in milliliters (mL) of the pump12 (Step123); and (5) the operating parameters of a PCA mode in milligrams (mg) of the pump12 (Step124). The continuous mode refers to a pump that continually delivers fluid to the patient, whereas the intermittent mode refers to intermittent delivery of fluids. The taper mode refers to a mode in which fluid delivery is stepped-up to a base rate then stepped-down to a “keep vein open” rate periodically during administration. The PCA mode refers to the ability of the patient to self-administer an additional burst (or “bolus”) of the fluid being administered by the pump. In other words, when the present dosage of analgesia being administered to the patient by the pump is inadequate to relieve pain, the patient can self-administer a bolus shot to bolster the dosage being automatically delivered by the pump.
If the care provider selects review of the continuous mode (Step120), thehomebase14 provides the care provider with a variety of information. The care provider is told whether the protocol is locked or unlocked (Step125); whether the “air-in-line” (AIL) alarm is on or off (Step126); the elapsed time in hours, minutes, and/or seconds of the present administration to the patient (Step127); the programmed rate of fluid being delivered in mLs per hour (Step128); the current rate of fluid in mLs per hour (Step129); the volume of fluid to be infused in mLs (Step130); the volume of fluid already infused (Step131); the level in mLs at which the low volume alarm will sound (Step132); and the last occurrence of the alarm (Step133). (See alsoFIG. 10, which illustrates the alarm table.) After providing this information to the care provider, thehomebase14 inStep134 returns to themain menu82.
If the care provider selects review of the intermittent mode (Step121), thehomebase14 also provides the care provider with a variety of information. Steps135-137 provide the same information asSteps125127, respectively. Step141 provides the same information asStep131, and Steps145-146 provide the same information as Steps132-133, respectively. Additional information provided to the care provider in the intermittent mode is as follows: the programmed dose rate of fluid being delivered in mLs per hour (Step138); the current dose rate of fluid in mLs per hour (Step139), the dose volume of fluid to be infused in mLs (Step140); the background rate in mLs per hour (Step142); the time between doses (or “Q” hours) (Step143); and the number of doses (Step144). After providing this information to the care provider, thehomebase14 returns inStep147 to themain menu82.
If the care provider selects review of the taper mode (Step122), thehomebase14 also provides the care provider with a variety of information. Steps148-150 provide the same information as Steps125-127, respectively.Step154 provides the same information asStep131, and Steps157-158 provide the same information as Steps132-133, respectively. Additional information provided to the care provider in the taper mode is as follows: the programmed base rate of fluid being delivered in mLs per hour (Step151); the current base rate of fluid in mLs per hour (Step152); the volume of fluid before taper down in mLs (Step153); the step-up rate in mLs per hour (Step155); and the step-down rate in mLs per hour (Step156). After providing this information to the care provider, thehomebase14 returns inStep159 to themain menu82.
If the care provider selects review of the PCA mL mode (Step123), the care provider is also given information. Steps160-162 provide the same information as Steps125-127, respectively. Steps165-166 provide the same information as Steps130-131, respectively, and Steps172-173 provide the same information as Steps132-133, respectively. Additional information provided to the care provider in the PCA mL mode is as follows: the programmed continuous rate of fluid being delivered in mLs per hour (Step163); the current continuous rate of fluid in mLs per hour (Step164); the bolus volume of fluid in mLs (Step167); the bolus interval in hours and minutes (Step168); the number of boli/hour (Step169); the number of boli attempted (Step170); and the number of boli delivered (Step171). After providing this information to the care provider, thehomebase14 returns inStep174 to themain menu82.
If the care provider selects review of the PICA mg mode (Step124), the care provider is given other information. Steps175-177 provide the same information as Steps125-127, respectively, and Steps188-189 provide the same information as Steps132-133, respectively. Additional information provided to the care provider in the PCA mg mode is as follows: the concentration of fluid delivered in mg/mL (Step178); the programmed continuous rate of fluid in mgs/hour (Step179); the current continuous rate in mg's/hour (Step180); the mgs to be infused (Step181); the mgs infused in mgs (Step182); the bolus dose in mgs (Step183); the bolus interval in hours and minutes (Step184); the number of boli/hour (Step185); the number of boli attempted (Step186); and the number of boli delivered (Step187). After providing this information to the care provider, thehomebase14 returns inStep190 to themain menu82.
With reference toFIG. 6, the edit mode will be described in detail. If the care provider has selected the edit mode inStep67, thehomebase14 transfers (circle71) the care provider to anedit mode menu200 illustrated inFIG. 6. Upon accessing this menu, thehomebase14 generates a number of voice queries that are transmitted to the care provider and provide the care provider with a number of options—namely: (1) editing the operating parameters of the continuous mode (Step201); (2) editing the operating parameters of PCA mL mode (Step202); and (3) editing the operating parameters of the PCA mg mode (Step203). No matter which option is selected, after editing the operating parameters (or protocol) of that mode, the care provider is transferred (see circle204) to theedit mode sub-menus270,280 illustratedFIG. 7.
If the care provider selects editing of the continuous mode (Step201), the homebase14 permits the care provider to edit the rate of delivery. In this mode, some parameters are maintained and others may be edited. The care provider is told the current rate at which thepump12 is delivering fluid in mLs/hour (Step210). The care provider is then asked to enter a new rate, or press the “#” button to accept the current rate (Step211). Finally, the care provider is told the new rate in mLs/hour and is asked to press the “#” button on the key pad to accept the new rate (Step212). After the rate has been edited, thehomebase14 transfers (circle204) to the sub-menus270,280 ofFIG. 7.
If the care provider selects editing of the PCA mL mode (Step202), the care provider is asked to edit various parameters of the PCA mL protocol. The care provider is first told what the current continuous rate is in mLs/hour (Step221), and inStep222 is asked to enter a new continuous rate or press the “#” button to accept the present rate. The care provider is then told what the new rate is and asked to press the “#” button to accept that new rate (Step223). Similar operations are performed on the bolus volume (Steps224-226), the number of boli/hour (Steps227-229), and the bolus interval (Steps230-232). After editing, thehomebase14 transfers (circle204) to the sub-menus270,280 ofFIG. 7.
If the care provider selects editing of the PCA mg mode (Step203), the care provider is asked to edit various parameters of the PCA mL protocol. The care provider is first told what the current continuous rate is in mgs/hour (Step241), and in Step242 is asked to enter a new continuous rate or press the “#” button to accept the present rate. The care provider is then told what the new rate is and asked to press the “#” button to accept that new rate (Step243). Similar operations are performed on the bolus volume (Steps244-246), the number of boli/hour (Steps247-2491, and the bolus interval (Steps250-252). After editing, thehomebase14 transfers (circle204) to the sub-menus270,280 ofFIG. 7.
Referring now toFIG. 7, theedit mode sub-menus270,280 provide the care provider with several options after editing the protocol. The first edit mode sub-menu270 allows the care provider to send (i.e., save) the edits to thepump12 (Step271) by pressing a certain key on the key pad (in this case “1”), to review the edits (Step272) by pressing a different key on key pad (in this case “2”), and to cancel the edits (Step273) by pressing still a different number on she key pad (in this case “3”). If the care provider selects sending the edits (Step271), the new protocol is sent to the pump12 (Step274), and the care provider is told “goodbye” (Step275). The care provider is then transferred to the phone or patient conversation mode (Step276), and the care provider is put in connection with the patient to verify the programming (Step277). After verifying the programming changes with the patient, the care provider hangs up the remote telephone (Step278), and the programming session is terminated.
If the care provider selects reviewing the edits (Step272), the homebase14 reports the new parameters of the protocol to the care provider (Step279). After reporting, the care provider is taken to the secondedit mode sub-menu280. The secondedit mode sub-menu280 permits the care provider to select one of several options: (1) send the edits by pressing a key on the key pad (Step281), (2) edit the edits by pressing a different key on the key pad (Step282), or (3) cancel the edits by pressing still a different key on the key pad (Step283). If the care provider selects sending the edits (Step281), the new protocol is sent to the pump12 (Step284), and the care provider is told “goodbye” (Step285). The care provider is then transferred to the phone or patient conversation mode (Step286), and the care provider is put in connection with the patient (the patient conversation mode) to verify the programming (Step287). After verifying the programming changes with the patient, the care provider hangs up the remote telephone (Step288), and the programming session is terminated. If the care provider selects editing of the edits (Step282), the care provider is transferred to the edit mode menu (Step289) illustrated inFIG. 6 and described above. If the care provider selects cancelling of the edits (Step283), the care provider is transferred to the main menu82 (Step290).
With reference toFIGS. 8A and 8B, the create mode will now be described. If the care provider selects the create mode inStep68, thehomebase14 transfers the care provider to a createmode menu300. Within the createmode menu300, the care provider has several options for processing the protocol: (1) thecontinuous mode302, (2) theintermittent mode304, (3) thetaper mode306, and (4) thePCA mode308. For any of these modes to be selected, the care provider presses a predetermined number on the keypad of the remote programming transceiver or push button telephone.
If the care provider selects programming of thecontinuous mode302 from thecreate mode menu300, the care provider is asked to program various parameters of the continuous mode protocol. The care provider is asked to enter the rate (Step310), after which the entered rate is read back, and the care provider is asked to press the “#” button to accept this rate (Step311). The care provider follows the same procedure for entering volume (Steps312 and313), low volume alarm (Steps314 and315), protocol locking (Steps316 and317), and AIL on or off (Steps318 and319). After programming, the care provider is transferred (circle397) to the sub-menus ofFIG. 9.
If the care provider selects programming of theintermittent mode304, the care provider is asked to program various parameters of the intermittent mode protocol. The care provider is asked to enter the number of “Q” hours (Step320), after which the entered number of “Q” hours is read back, and the care provider is asked to press the “#” button to accept this number (Step321). The care provider follows the same procedure for entering dose rate (Steps322 and323), dose volume (Steps324 and325), background rate (Steps326 and327), number of deliveries (Steps328 and329), low volume alarm (Steps330 and331), protocol locking (Steps332 and333), and AIL on or off (Steps334 and335). After programming, the care provider is transferred (circle397) to the sub-menus ofFIG. 9.
If the care provider selects programming of thetaper mode306, the care provider is asked to program various parameters of the taper mode protocol. The care provider is asked to enter the total volume (Step336), after which the entered total volume is read back, and the care provider is asked to press the “#” button to accept (Step337) this volume. The care provider follows the same procedure for entering taper up time (Steps338 and339), taper down time (Steps340 and341), and total delivery time (Steps342 and343). Thehomebase unit14 then calculates the base rate (Step344) and reads this base rate back to the care provider (Step345); calculates the volume before taper down (Step346) and reads this volume back to the care provider (Step347); and calculates the step up and step down rates (Steps348 and350) and reads these back (Steps349 and351). The care provider is also asked to enter protocol locking (Steps352 and353) and AIL on or off (Steps354 and355). After programming, the care provider is transferred (circle397) to the sub-menus ofFIG. 9.
If the care provider selects programming of thePCA mode308, the care provider is taken to aPCA mode sub-menu360. In thePCA mode sub-menu360, the care provider is asked to select the PCA mL mode (Step361) or the PCA mg mode (Step362). If the care provider selects the PCA mL mode, the care provider is asked to enter the protocol of this mode, including the continuous rate (Steps363 and364), total volume (Steps365 and366), bolus volume (Steps367 and368), number of boli/hour (Steps369 and370), bolus interval (Steps371 and372), low volume alarm (Steps373 and374), protocol locking (Steps375 and376), and AIL on or off (Steps377 and378). If the care provider selects the PCA mg mode (Step362), the care provider is asked to enter that mode's protocol, including the concentration (Steps379 and380), continuous rate (Steps381 and382), total volume (Steps383 and384), bolus volume (Steps385 and386), number of boli/hour (Steps387 and388), bolus interval (Steps389 and390), low volume alarm (Steps391 and392), protocol locking (Steps393 and394), and AIL on or off (Steps395 and396). After programming, the care provider is transferred (circle397) to the sub-menus ofFIG. 9.
Referring now toFIG. 9, after a programming sequence in accordance withFIGS. 8A and 8B, the care provider is transferred (via circle397) to a primary createmode sub-menu400. In the primary createmode sub-menu400, the care provider can make various selections, including sending the newly programmed protocol (Step402), reviewing the newly programmed protocol (Step404), and cancelling the newly programmed protocol (Step406). If the care provider selects send (Step402), the care provider is told that the new protocol is being sent to thepump12 and then told “goodbye” (Steps410 and411), and the connection is switched to the phone or patient conversation mode (i.e., communication with the patient) (Step412). The care provider may then speak with the patient to verify the programming (Step413) and then hang up after verifying (Step414). If the canceloption406 is selected, the care provider is transferred (Step437) to themain menu82.
If thereview option404 is selected, the parameters of the new programmed protocol are reported to the care provider (Step415). The care provider is then transferred to a secondary createmode sub-menu420, from which the care provider can select various options, including sending the new protocol (Step422), editing the new protocol (Step424), and cancelling the new protocol (Step426). If the sendingoption422 is selected,Steps430 through434 are performed, which are the same as those performed if the care provider were to select the sendingoption402 from the primary createmode sub-menu400. If theediting option424 is selected, the care provider is transferred (Step435) to the createmode menu300. Finally, if the canceloption424 is selected, the care provider is transferred (Step436) to themain menu82.
In all of the above processing modes, thehomebase14 can be provided with a variety of features that facilitates remote or local programming of the protocol. For example, “#” key can be used to enter changes or selections. The “*”key can be used for exiting the programming mode, for backspacing from a currently operating step to a previous step or from a portion of a parameter being processed to a previous portion of that parameter, or for entering a decimal point, depending on the instance in the programming sequence. The system can be set up such that it rejects out of range values and advises on the erroneous value. If the communicating phone line is equipped with call waiting, the existence of an incoming call on the additional call waiting line does not cause the presently communicating (i.e., programming) line to hang up. With reference toFIG. 10, an alarm table500 of the present invention will be described. The alarm table500 may include a variety of alarm functions, including air in theline alarm502 for theline18 connecting thepump12 to the patient, abad battery alarm504, a barcode fault alarm506, an alarm indicating the need for abattery change508, a dooropen alarm510, an end ofprogram alarm512, alow battery alarm514, alow volume alarm516, amalfunction alarm518, anocclusion alarm520, anover-voltage alarm522, a pump interruptedalarm524, and a pumpingcomplete alarm526. All of these alarms can be made audible, with a variety of different or identical tones, or visual, via thealarm light40, multiple lights, or a digital or analog display. The above alarm functions are exemplary, and other alarm functions can be provided. Alternatively, only some, or one, or none of the above alarm functions can be implemented in the present invention, depending on the particular application.
Examples of how thealarm light40 andinternal audio device29 operate in response to various alarm conditions will now be described. Thealarm light40 may comprise a number of lights, for example, red, yellow, green, and other colored LEDs. Theaudio device29 may comprise a speaker, siren, or similar apparatus. As an example of an alarm condition and the response thereto, if the phone line is improperly connected to thehomebase unit14 or theinfusion system10 is setup in some other improper manner, red and green LEDs (which comprise the alarm light40) may flash together with intermittent audio from theaudio device29. If someone is trying to access the local mode (i.e., communicate with thehomebase14 via a local telephone connected to the local communication port44) without the local telephone line being attached to thehomebase14, a yellow LED may flash with intermittent audio. If someone is trying to access the local, send, or link modes (i.e., is depressing thelink button30,local button32, or send button34) without thepump12 being properly attached to thehomebase14, yellow and red LEDs may flash with intermittent audio. If the telephone connection between the remote or local telephone and thehomebase14 is lost, a red LED may flash with intermittent audio. Finally, if an internal system error occurs in thehomebase14 and/or pump12, a red LED may flash with intermittent audio. It should be understood that the above operation of thealarm light40 andaudio device29 are only exemplary and that variations can be made on these alarms.
It should also be understood that the above programming and functions described inFIGS. 3-10 provide only examples of how the care provider and thehomebase unit14 may interact via a remote or local push button telephone or similar transceiver. Therefore, additional or alternative steps and procedures can be designed and implemented for remote programming of the present invention. Accordingly, only some of the steps described above need be included in the invention; the steps may be conducted in a different order; additional or fewer protocol parameters may be controlled by the care provider; and different operational modes (i.e., other than continuous, intermittent, etc.) may be chosen.
Furthermore, the present invention can be used in a variety of applications. In the exemplary application described herein, the present invention is used for controlling and programming the protocol of an infusion pump. A variety of infusion applications exist for which the present invention can be used, including ambulatory IVs, insulin pumps, hospital pumps, enteral pumps, blood pumps, intra-aortal pumps, subcutaneous pumps, and spinal (or epidural) pumps. Other medical applications also exist in which the present invention can be used for remote programming, as well as other functions described above, including use with ventilators (e.g., for blood/oxygen level), respiratory equipment, EKG machines, blood/gas analyzers, enteral pumps (i.e., stomach infusion pumps), blood glucose monitors, dialysis equipment, open wound irrigation devices, and urology equipment.
It will therefore be apparent to those skilled in the art that various modifications and variations can be made in the apparatus and method of the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention, provided they come within the scope of the appended claims and their equivalents.