HK1036718B - Method and apparatus for monitoring a patient - Google Patents

Description

Method and apparatus for monitoring a patient

Technical Field

The present invention relates to a remotely accessible healthcare system for medical applications. The invention relates particularly to a patient's medical device that allows a health care provider remote from the patient to monitor the patient's medical status and to edit the patient's protocol, record changes to the patient's protocol, and notify the care provider upon an alarm condition.

Background

Due to the rising cost of healthcare, the high cost of hospital beds, and the desire to provide comfort and convenience to patients, the medical industry has proposed home care for patients suffering from various diseases. Many patients must be connected to various medical devices. These medical devices often monitor certain parameters related to the health of the patient and have controls that must be adjusted due to changes in the patient's needs. Changes in treatment methods may also require the entire protocol to be programmed. In early versions of these medical devices, care providers were required to be present in the field to adjust the protocol of the device. Such reprogramming is expensive and time consuming.

In addition, health care providers, such as hospitals, health insurance institutions that pay for health care, now often require certification of all medical procedures. For example, a health insurance agency may require the patient to demonstrate certain parameters that measure their health to a certain degree in order for the patient to be compensated, or the agency may require evidence that the device is actually being used. Moreover, patients or their care providers at home often cannot notify the care providers of the occurrence of alarms associated with medical devices, and in some cases patients may fiddle with the devices in response to alarm conditions.

Accordingly, there is a need for a remotely controllable medical device system that is capable of notifying a care provider by reporting alarm conditions to a remote fax machine or computer or other healthcare worker of the care provider and sending status reports.

Summary of The Invention

The present invention derives a remotely programmable medical device system and a method of remotely programming a medical device system via a remote transceiver that achieves the above objectives.

The system of the present invention allows a care provider to obtain the status of a patient from a remotely located medical system connected to the patient, change the patient's protocol, or request a document for certification upon receiving a voice synthesized command via a remote transceiver having a touch-tone keypad. The method is simple to use and does not need training; it allows a care provider to perform the functions described above, regardless of where the phone is located. If the care provider has access to a computer, he can perform the above functions as if using a telephone, and can also view the real-time status of the patient on the computer screen, which status is changed by image or tabular form or send a file with the desired parameters to the system to program the medical device.

The caregiver computer may also instruct the system to automatically send status reports to designated locations at set intervals and automatically summon the caregiver to report an alarm condition. Further, the system can remotely program a plurality of medical devices connected to one or more patients or remotely program protocols for a plurality of patients in a single programming session by accessing the central data store.

To achieve these and other advantages and in accordance with the purpose of the present invention, as embodied and broadly described herein, the present invention defines a remotely programmable and accessible medical device system having a programmable protocol that is remotely programmable via a remote transceiver, such as a touch-tone telephone or computer. Alternatively, the medical device may not have a programmable protocol. For example, the device may only monitor vital signs of the patient. The remote programmable medical device system of the present invention includes a memory for storing a programmable protocol or activity record and a remote communications port for transmitting voice signals to a remote transceiver, transmitting data to a remote fax machine or computer, and receiving remote programming signals from the remote transceiver. The system also includes a voice storage unit for storing voice signals, and a processor coupled to (1) the remote communication port for processing the programmable protocol in response to receipt of the remote programming signal; (2) a voice storage unit for accessing the voice signal from the voice storage unit; and (3) a memory for accessing the programmable protocol from the memory.

In an additional aspect, the invention comprises a medical device system having a programmable alarm routine stored in memory. The medical device system comprises a medical device having a data port, and an interface unit on the medical device connected to or integrated with the data port of the medical device via an interface data port. The interface unit further includes a voice storage unit for storing a voice signal indicating that an alarm condition has occurred, and a remote communication port for automatically transmitting the voice signal to a remote touch-tone transceiver or automatically transmitting data regarding the alarm condition to a remote fax machine or computer. The interface unit further comprises a processor coupled to (1) the remote communication port for processing the alarm condition in response to receiving the medical device alarm signal; (2) a voice storage unit for accessing the voice signal from the voice storage unit; and (3) a memory for accessing the alarm routine from the memory. Signals from an alarm on the medical device are converted to the interface data port via the medical device data port.

In another aspect, the invention comprises a remotely programmable medical device system having a programmable protocol stored in a protocol memory, the system being programmable by a remote transceiver. The medical device system comprises an interface unit and at least one medical device, each medical device having a data port and an interface unit, the interface unit being connected to or integrated with each data port of the respective medical device via an interface data port. The interface unit further includes a voice storage unit for storing voice signals, and a remote communication port for automatically transmitting voice signals to a remote touch-tone transceiver, transmitting data to a remote fax machine or computer, and for receiving remote programming signals (such as dual audio multi-frequency signals in the case of a remote telephone) from the remote transceiver. The interface unit further comprises a processor coupled to (1) the remote communication port for processing the programmable protocol in response to receipt of the remote programming signal; (2) a voice storage unit for accessing the voice signal from the voice storage unit; and (3) a memory for accessing the programmable protocol from the memory. The processed programmable protocol is converted from the processor to the medical device via the interface data port.

In another aspect, the invention comprises a remotely programmable medical device system having a plurality of patient programmable protocols stored in a central memory, the system being programmable via a remote transceiver. The system comprises a remote central data storage unit, a plurality of medical devices connectable to a plurality of patients, an interface unit for each patient, and a data port for each medical device having a data port connected to its respective interface unit. Each interface unit contains a voice storage unit for storing voice signals and a remote communications port for sending digital signals to a remote central data store, sending data to a remote fax machine or computer, and for receiving remote programming signals (such as digital signals in the case of a computer) from a remote touch-tone transceiver. Each interface unit further comprises a processor coupled to (1) its remote communication port for processing the programmable protocol in response to receipt of a remote programming signal; (2) the voice storage unit is used for accessing the voice signal from the voice storage unit; and (3) its memory for accessing the programmable protocol from its memory. The processed programmable protocol is converted from the processor to the medical device via the interface data port. The remote central data storage unit comprises: a voice storage unit for storing the voice signal; a first communication port for transmitting voice signals to a remote touch-tone transceiver, transmitting data to a remote fax machine or computer, and for receiving remote programming signals from the remote touch-tone transceiver; and a second communication port for transmitting signals to or receiving signals from the data port of the medical device. The remote central data storage unit further comprises a processor coupled to (1) the first remote communication port for processing the programmable protocol in response to receipt of the remote programming signal; (2) a second remote communication port for processing a programmable protocol to be transmitted to the interface unit of the patient; (3) a voice storage unit for accessing the voice signal from the voice storage unit; and (4) a memory for accessing the programmable protocol from the memory. The processed programmable protocol is converted from the remote central data storage unit to the processor of the interface unit via the second remote communication port.

Further objects, features, and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings.

Brief Description of Drawings

FIG. 1 schematically illustrates a medical system of the present invention by which a caregiver can remotely access and control medical devices associated with a patient;

FIG. 2 schematically illustrates an interface arrangement of the system illustrated in FIG. 1;

FIG. 3 is a flow chart demonstrating the general control mechanism of the interface;

FIG. 4 is a flow chart illustrating one mode of computer programming of the system;

FIG. 5 is a flow chart illustrating a menu of access codes for the system;

FIG. 6 is a flow chart illustrating an alarm control menu of the system;

FIG. 7 demonstrates the relationship between the graphs in FIGS. 7A1, 7A2, and 7A 3;

7A 1-7A 3 are flow diagrams illustrating a portion of the main menu of the system illustrated in FIG. 3 that is suitable for use with a mechanical ventilator;

FIG. 7B is a flow chart demonstrating a fax reporting menu suitable for a system using a mechanical ventilator;

FIG. 7C is a flow chart demonstrating a sendfile menu suitable for a system using a mechanical ventilator;

FIG. 7D is a flow chart demonstrating an edit protocol submenu suitable for a system using a mechanical ventilator;

FIG. 8A is a flow chart illustrating a portion of a main menu of the system illustrated in FIG. 3 suitable for use with a vital signs monitor;

FIG. 8B is a flow chart demonstrating a fax reporting menu suitable for a system using a vital signs monitor; and

fig. 8C is a flow chart demonstrating a send file menu suitable for a system using a vital signs monitor.

Description of The Preferred Embodiment

Reference will now be made in detail to the preferred embodiments of the present invention, examples of which are 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 medical device system is provided that allows communication with and programming of medical devices from a remotely located transceiver, such as a touch-tone telephone or computer. The system includes a memory, a voice storage unit, a remote communication port, and a processor coupled to the remote communication port, the voice storage unit, and the memory. It should be understood that the terms "program," "programmable," and "process" are used herein as generic terms that refer to a set of operations, functions, and data manipulations. Thus, these terms are not limited to editing and deleting data, parameters, and code herein. Programming and processing as used herein may include, for example, editing, changing, deleting, entering, re-entering, browsing, checking, locking, and inserting functions.

An exemplary embodiment of the system of the present invention is shown in fig. 1, and is generally indicated by reference numeral 10. As embodied herein and shown in FIG. 1, the remotely programmable medical device system 10 includes a medical device 12 and an interface unit 14. The medical device preferably includes a patient connection 16, such as a wire, through which patient data, such as from sensors, is transmitted.

The interface 14 includes a cable 20 for connecting the interface 14 to the medical device 12, controls 22 for controlling the operation of the interface 14, indicator lights 24 for indicating various states of the interface 14, and an internal voice device for providing voice warning signals. As embodied herein, the control 22 includes a connect button 28, a home button 30, and a send button 32. Alternatively, the local button 30 may not be present, as would be readily understood by one skilled in the art. Indicator lights 24 include a waiting indicator light 34, a telephone/computer indicator light 36, and an alarm indicator light 38. The functions of the control 22 and indicator lights 24 will be described in detail below. Interface 14 also preferably includes a remote communication port 40 and a local communication port 42.

As an alternative to being connected by the electrical cord 20, the interface 14 and the medical device 12 may communicate through an interface data port 44 and a medical device data port 46, each of which includes a wireless transmitter/detector pair. Preferably, each of the data ports 44 and 46 includes an infrared or radio frequency emitter/detector to allow wireless communication between the medical device 12 and the interface 14. Other wireless communication ports may also be used. A power cable 20 is preferably used to provide power to the medical device 12 through the interface 14. Alternatively, the medical device may have its own power cable, not connected through the interface 14, but directly connected to a power source (not shown).

As embodied herein, remote communication port 42 and local communication port 40 (if present) each comprise a standard modem known to those skilled in the art. The modem may operate at 28800 baud or other baud rates. The system may be arranged so that a care provider, located in the vicinity of the patient, such as in a ward of a hospital when the patient is present, can access the interface 14 through the local port 40. On the other hand, if the care provider is remote from the medical device system 10, the system is preferably arranged such that when the connection button 28 is pressed, the remote communication port 42 is activated. In this manner, the care provider can communicate with the interface 14 via a remote transceiver, such as a telephone 48 or computer 50. It should be understood that interface 14 may contain only a single port instead of separate local and remote ports through which signals are input and output.

For convenience, the description herein refers to a caregiver using a telephone or personal computer to remotely access the medical device 12, but it should be understood that any transceiver can activate or select the programmable parameters independently and in response to various prompts and queries. It should also be understood that the term "remote touch-tone transceiver" is not limited to conventional touch-tone telephones having 12-key keypads, including the 0-9, star, and # keys. Rather, as defined herein, the term "remote touch-tone transceiver" refers to any transceiver capable of generating signals via a keypad or other data entry system, and is therefore not limited to transceivers that generate DTMF signals, such as conventional telephone sets. Examples of other types of "touch-tone transceivers" as defined herein include computers having keyboard and/or cursor control devices, conventional touch-tone telephones, transmitters that convert human voice into pulsed or digital or analog signals, and pager transceivers.

With reference to fig. 2, the elements included in the interface 14 will be described in more detail. As stated previously, the interface 14 includes the remote communication port 42, the local communication port 40, a protocol and event memory 52, a speech storage unit 54, a processor 56, a speech synthesizer 58, and an access code memory 60. Alternatively, the protocol and event memory 52 and the processor 56 may be an integrated unit. The protocol memory 52, the speech storage unit 54, and the access code memory 60 may be contained in the same memory device (such as a random access memory) or in separate memory units. Preferably, the voice storage unit 54 includes a Read Only Memory (ROM). The interface 14 also includes a data port 43 for communicating information between the interface 14 and the medical device 12 (e.g., via the electrical wire 20 or via the emitter/detector 44). The speech synthesizer 58 is preferably an integrated circuit that converts digitized speech signals into signals that simulate human speech. As embodied herein, the speech synthesizer 58 need only be used to convert output signals from the interface 14 to the remote telephone 48, and does not require conversion of input signals from the remote telephone 48 or from the remote computer 50 or output signals to the remote computer 50. The speech synthesizer may include a commercially available speech synthesis chip.

Remote communication port 42, local communication port 40, and interface data port 44 are all connected to the processor via data buses 62a, 64a, and 66a, respectively. The communication ports 40, 42 receive signals from the transceivers 48, 50 and communicate the signals to the processor 56 via the buses 62a, 64a, respectively, and the processor 56 processes the signals and performs various operations in response to the signals. If the care provider selects the remote mode from the telephone 48, the processor 56 receives digitized voice signals from the voice storage unit 54 via the bus 70a and sends these digitized signals to the voice synthesizer 58 via the bus 70b where they are converted to voice analog signals at the voice synthesizer 58. These voice analog signals are sent from the voice synthesizer 58 to the buses 62a, 64a, and 66a via the buses 62b, 64b, and 66b, which pass the signals to the remote communication port 42, the local communication port 40, and the interface data port 44, respectively.

For example, if desired, an indication is provided to the care provider to operate the remote telephone 48. The processor 56 sends a voice address signal to the voice memory unit 54 via the data bus 70a connected thereto. The voice address signal corresponds to a location in the voice storage unit 54 that contains a particular voice signal to be transmitted to the remote transceiver 48. Upon receiving the voice address signal, the particular voice signal is accessed and sent from the voice memory unit 54 to the processor 56 via the data bus 70 a. The processor 56 then passes the voice signal via data bus 70b to the voice synthesizer 58, which converts the voice signal and transmits the converted signal via data buses 62b and 62a to the remote communications port 42, which transmits the converted signal to the remote transceiver 48.

The speech signals retrieved from the speech storage unit 54 may be digitized human speech or computer generated speech signals (both of which are well known to those skilled in the art). The digitized speech signal is converted by the speech synthesizer 58 into a signal that mimics human voice. The voice signal indicates to the care provider how to respond to the voice signal and what information should be sent. Since the remote transceiver may be a touch-tone telephone having a keypad with a plurality of keys, the care provider presses the appropriate key, thereby sending a DTMF signal back to the remote communications port of interface 14. It should be understood, however, that the remote transceiver need not be a touch-tone telephone, but may be any transceiver capable of transmitting and receiving DTMF or other similar signals. The remote transceiver may be a computer or a portable controller, for example.

If the DTMF signal transmitted by the care provider is a remote programming signal transmitted from the remote telephone 48 to the remote communications port 42 of the interface 14, the remote communications port 42 then passes the remote programming signal to the processor 56 via the data bus 62 a. In response to receiving the remote programming signal, the processor 56 accesses a particular parameter of the programming protocol from the protocol memory 52. To access the parameters, the processor 56 sends a protocol address signal over a data bus 68 connecting the processor 56 and the protocol memory 52. The protocol address signal corresponds to a location in the protocol memory 62 containing the parameter. The parameters are then sent from the protocol memory 52 to the processor 56 via the data bus 68. Depending on the nature of the remote programming signal, the processor 56 can then perform a series of operations on the parameter, including editing, deleting, or sending the parameter back to the remote transceiver 48, 050 for review. Those skilled in the art will recognize that many types of signals or commands may be sent from the remote transceiver 48, 050 to the interface 14 for processing. Examples of such signals, how they are processed, and their effects will be described in detail later with a description of the functionality of the invention.

In accordance with the present invention, the medical device system 10 may incorporate various security devices to prevent unwanted access to the interface 14 and corresponding medical device 12. Notably, a user access code, which may be a multiple decimal number (preferably four decimal numbers), may be used to block access to individuals other than those having the user access code. The medical device system may be equipped with one or more user access codes, which are stored in an access code memory. To initiate communication with the medical device system 10, a caregiver connects to the medical device system via the remote touch-tone transceivers 48, 50. This connection may be initiated by a call from the care provider to the medical device system 10 (or the patient talking to a phone near the medical device system), or by a call from the patient to the care provider, both methods where the care provider is connected to the medical device system 10. After the connection between the care provider and the medical device system 10 is established, the interface 14 is preferably set to require the care provider to enter a user access code. If the care provider enters a valid user access code (there may be multiple valid codes, as explained earlier), the care provider is allowed to access and/or program the programmable protocol.

During a programming session, under certain circumstances (described below), the user access code may be checked, edited, and/or completely deleted and re-entered. To perform any of these functions, programming signals are sent by the care provider from the remote transceivers 48, 50 to the interface 14. The programming signals are communicated to the processor 56 through the remote communication port 42, and the processor 56 processes the signals and generates an access code address signal. The access code address signal corresponds to a memory location in the access code memory 60 where the user access code is stored, and is sent to the access code memory 60 via the data bus 72. The particular user access code is then retrieved and sent back to the processor 56 via the data bus 72, which processes the user access code in some manner.

The interface is equipped with an interface data port 43 for communication with the medical device system 10. The medical device protocol may be transmitted from the interface 14 to the medical device 12 via the interface data port 43 and the medical device data port 46. Thus, for example, the processor 56 accesses the protocol from the protocol memory 52 and sends the protocol to the interface data port 43 via the data bus 66 a. The interface data port 43 then sends information (such as via the electrical wire 20 or wireless transmitter/transceiver 46) to the medical device data port, where the information is processed in the medical device 12 by circuitry and/or software. In this manner, the medical device protocol may be programmed (e.g., edited, reconstructed, checked, locked, re-entered, etc.).

The send button 32 is designed to allow the transmission of medical device data or protocols to a remote location, such as a computer 74 or a fax machine 76. In this manner, a remote record is maintained, such as on a computer. If the computer 74 is remote from the medical device system 10, a person at the interface 14 may press the send button 32 to download the existing protocol or data to the remote communication port 42. The protocol is then transmitted to the remote computer 74 via the remote communication port 42.

The connect button 28 is preferably used to initiate or enter a remote programming mode of the medical device system 10. Upon initiation of a programming session, the care provider calls the telephone number corresponding to medical device system 10 (or the patient's home phone). The patient 18 can answer the call with his or her telephone and the care provider can communicate with the patient via standard voice signals. Referred to herein as a phone mode or a patient session mode. The care provider then instructs the patient to press the connect button 28, which disconnects the patient 18 from the telephone line and initiates the programming mode, which is described below with reference to fig. 3-8. However, if the patient 18 does not answer the caregiver's call, the interface 14 may be equipped with an internal switching system that directly connects the caregiver to the interface 14 and initiates the programming mode. The internal switching may be implemented in hardware in the interface 14, or in software controlling the processor 56, or in a combination of hardware and software. In either way, the care provider may then begin processing the information and protocols stored in the interface 14. (As described previously, the call may be placed by the patient 18 to the care provider.)

The function of the indicator light 24 will now be described. Preferably, the indicator light 24 comprises an LED. The wait light 34 indicates when the interface 14 is in a programming session or when it is downloading protocols to a remote location, such as the remote computer 74. Accordingly, the wait light 34 tells the patient 18 not to disturb the interface 14, directing the wait light 34 to go off, indicating that the internal processing elements of the interface 14 are activated. The telephone lights 36 indicate when the care provider and patient 18 are communicating via the remote transceivers 48, 50 and, therefore, when the internal processing elements of the interface 14 are activated. Telephone light 36 may also indicate when medical device system 10 is ready.

The alarm lights indicate various alarm conditions and functions of the medical device system 10. Medical device 12 transmits to interface data port 43 via a medical device data port. The signal is communicated to the processor 56 via bus 66 a. Next, the processor 56 sends a voice address signal to the voice memory unit 54 via the data bus 70a connected to the processor 56. The voice address signal corresponds to a location in the voice storage unit 54 containing a voice signal pertaining to the warning condition that is to be transmitted to a remote location (such as 48, 50, 74, or 76). Upon receipt of the alert address signal, the alert signal is accessed from the voice storage unit 54 and sent to the processor via the data bus 70 a. The processor 56 then passes the voice signal to the voice synthesizer 58 via the data bus 70b, and the voice synthesizer 58 converts the voice signal and sends the converted signal to the remote communication port 42 via the data buses 62a, 62b, which sends the converted signal to the remote transceiver.

Remote access to medical devices of the system of the invention

Referring to fig. 3, a programming mode or a sequence of the present invention will be described in detail. A care provider may access and process the protocols of the interface from one of the remote telephone 48, remote computer 50 or other transceiver, as previously described. The programming mode by the remote telephone 48 will first be described. The care provider dials a telephone number corresponding to the medical device (step 1). A synthesized voice message will ask the caregiver whether to speak to the patient prior to the remote programming session (step 2). If the care provider selects "yes," the care provider communicates with the patient via standard voice signals (step 3). More specifically, the patient will lift the local phone 48A in communication with the local port 40 and talk to the care provider on the remote phone 48 in communication with the remote port 42. (see fig. 1) when the conversation is over, the care provider asks the patient to press the connect button on the interface (step 4), thereby connecting the care provider to the interface (step 5), ending the phone mode, and starting the remote push-to-program session. If the caregiver chooses not to talk to the patient prior to the remote programming session (step 6), the caregiver may choose "no" (step 6) and be directly connected to the interface 14, thereby directly starting a remote push-to-program session by entering the access code menu (FIG. 5) without entering talk mode.

Alternatively, the care provider may access and process the protocol of the interface from the remote computer 50. The care provider may dial the telephone number of the medical device system 10 by causing the modem of the remote computer 50. In the case where the device monitors only the vital signs of the patient, those skilled in the art will appreciate that the vital signs are available to the care provider. Initially, a message will appear on the caregiver's computer screen asking if the caregiver wishes to navigate through a menu containing additional options before entering the main menu. As shown in fig. 4, these options include, but are not limited to: sending the status of the patient to the care provider's computer (step 8); loading the new protocol from the file on the care provider's computer (step 9); activating a real-time monitoring mode so that a care provider can view the current status of the patient as the status of the patient changes (step 10); receiving a PM history of the device (step 11); and activating a diagnostic mode (step 12). If the caregiver chooses not to enter the special options menu (step 7), he can directly enter a remote programming session by entering the access code menu (FIG. 5).

Access code

If the user enters the correct access code (step 13), the user is preferably allowed to perform certain functions related to the access code. For example, and referring to FIG. 5, if a care provider has entered a master access code, the interface 14 generates voice queries (alphanumeric text signals representing the same message may be sent when the computer 50 is used for a telephone link) that are sent to the care provider and provide the care provider with options. First, at step 14, the care provider is asked whether a new primary access code is to be entered and instructed to press a particular button (in this case the number "1") on a touch-tone keypad to select the option. If the care provider selects this option, the interface 14 tells the care provider to enter the existing primary access code (step 15) and to enter a new primary access code (step 16). The newly entered primary access code is then fed back to the care provider by the interface 14 (step 17), and the interface 14 generates a voice command telling the care provider to press the "#" key on the keypad to confirm the new primary access code. If the care provider presses the "#" key, the interface 14 returns to the access code menu (step 18). Those skilled in the art will recognize that the care provider's depressed keys are examples only, and that other keys may be designated for confirming and/or selecting various options and programming inputs.

Second, at step 19, the care provider is asked whether a new user access code is to be entered and instructed to press a particular button (in this case the number "2") on the touch-tone keypad to select this option. If the care provider selects this option, the interface 14 tells the care provider to enter a new user access code (step 20). If a new user access code is entered already, the program loops, requiring the care provider to again enter a new primary access code (not shown). If the newly entered user access code does not exist, the new user access code is fed back to the care provider by the interface 14 (step 21), and the interface 14 generates a voice command telling the care provider to press the "#" key on the keypad to confirm the new user access code. If the care provider presses the "#" key, the interface 14 returns to the access code menu (step 22).

Third, at step 23, the care provider is asked if he or she will query the user access code and be instructed to press a particular button (the number "3" in this example) on the touch-tone keypad to select this option. If the caregiver selects this option, the interface 14 tells the caregiver that there are a certain number of user access codes (depending on how many are present) at step 24. At step 25, the interface 14 enumerates the user access codes to the care provider and continues to enumerate the user access codes until all codes are enumerated. After the user access code is enumerated, the interface 14 returns to the access code menu (step 26).

Fourth, at step 27, the care provider is asked if he or she will delete the user access code and is instructed to press a specific button (in this case the number "4") on the touch-tone keypad to select this option. If the care provider selects this option, the interface 14 asks the care provider to select one of the following two options: (1) delete the particular user code, press a particular button (in this case the number "1") on the touch-tone keypad (see step 28); or (2) delete all user codes and press another button (number "2" in this example) (see step 33). If the care provider selects step 28, the care provider is asked to enter a specific user access code to be deleted (step 29), and the interface 14 feeds back the specific user access code at step 30. The interface 14 then asks the care provider to press the "#" key on the touch-tone keypad to confirm the deletion of the access code for the user and return to the access code menu. If the caregiver selects step 33 (global delete), the interface 14 alerts the caregiver that he or she will delete all user access codes and requires the caregiver to press the "#" key to confirm (step 34). The interface then returns to the access code menu (step 35).

Fifth, at step 36, the care provider is asked to press a particular number ("5" in this example) to exit the access code menu. If the care provider selects this option, the interface 14 returns (per step 37) to the access code prompt.

The interface 14 may also be programmed so that access is prevented without entering an access code or security code (not shown).

Main menu

If the care provider has entered the correct user access code and has skipped or completed the functions described above in connection with the access code, the processor 56 accesses a set of voice queries containing the main menu from the voice storage unit (or via signals representing alphanumeric characters transmitted to a computer). Referring to fig. 3, a set of options is provided to the care provider via the main menu. The particular items provided may vary depending on the particular medical device used by the system, the number of medical devices used (as described below), or the number of patients connected to the system (as described below).

The main menu of fig. 3 demonstrates a menu that is generally useful for a wide variety of medical devices and provides a set of beneficial processes for the system of the present invention. It should be understood that other menu features may be provided. As demonstrated, the care provider is required to select from a number of options by pressing a key on a touch-tone keypad (or on a computer keyboard).

Certain options will be applied to each medical device, such as talking to the patient (step 38) and alert check mode (step 39). If the care provider chooses to talk directly to the patient, the connection is switched to a phone mode (step 40). In the phone mode, the care provider may talk to the patient to verify the programming changes (step 41). The care provider may then suspend the remote telephone 48 after ending the session with the patient (step 42). If the caregiver selects the alert check mode at step 39, the interface generates a voice query that is sent to the caregiver. As demonstrated in fig. 6, the care provider has the option of checking fax or telephone numbers that can be automatically dialed under alert conditions. For example, the synthesized speech would prompt that "warning notification number 1 is 123456790; the warning notification number 2 is 2345678 "(step 43). At step 44, the care provider has the option of deleting an existing number by entering the number to be deleted (step 45) through the transceiver. The care provider may choose to delete the extra number (step 46) or go to add an alert notification option (step 47). If the caregiver chooses to add an additional alert notification number at step 48, the caregiver can enter an additional number via the transceiver to add the number to be added. At step 49, the care provider is asked to either add another number or go to the main menu.

Options such as faxing a report or sending a document may also be applied to any medical device, but the type of report or document will vary depending on the medical device. Other options may be applied to some medical devices, such as editing or creating protocols, but not to others. Thus, these non-common options will be discussed below in connection with a particular medical device (see step or circle "D").

System of the invention adapted for multiple medical devices and/or multiple patients

In a variant of the invention, the system may be arranged to allow access and control of a plurality of medical devices. In this arrangement, a plurality of medical devices are preferably arranged to communicate with a single interface. In one method of accessing and controlling these devices, upon entry of an access code, the care provider will be prompted to enter the device number of the particular device that the care provider wishes to access.

Another embodiment, operates in the same manner as the embodiment described above. However, this embodiment may be used with multiple patients and includes multiple medical devices connectable to multiple patients, an interface unit connected to each patient's medical device, and a central data storage unit. The central data storage unit performs the same function as one interface unit but serves as a central storage location for protocols for multiple patients. This embodiment allows the care provider to choose to call a number from the remote transceiver, the number of the central data storage unit, instead of calling the number of each patient, to program the protocols for multiple patients; however, if the care provider is willing to program the protocols for a single patient, the care provider still retains the option of calling the interface unit for a particular patient. The remote central data storage unit includes two remote communication ports, a protocol and event memory, a voice storage unit, a processor, a voice synthesizer, and an access code memory. The protocol memory, the voice storage unit, the voice synthesizer, and the access code memory are the same as the corresponding portions of the interface unit. Each of the two telecommunication ports is connected to the processor via a data bus. The first telecommunication port receives signals from a remote transceiver and transmits the signals over a data bus to the processor, where the processor performs various operations in response to the signals. The signals are then sent via the data bus to a second telecommunication port, which then passes the signals to the designated interface unit via the telecommunication port of the interface unit. These signals are then processed in the same manner as the interface unit processor would process signals from a remote touch-tone transceiver without a central data storage unit,

it should be understood that the programming and functionality described above provide only examples of how the care provider, interface unit, and central data storage unit interact through a remote touch-tone transceiver. Thus, additional or alternative steps and processes may be devised and implemented for remote programming of the present invention. Thus, only a portion of the steps described above need be included in the present invention; these steps may be performed in a different order; additional or fewer protocol parameters may be controlled by the care provider; different modes of operation may be selected.

Further, the present invention can be applied to various medical devices. As described below, the present invention is used to check and program the protocols of mechanical ventilators and vital signal monitors. It will 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, the present invention covers any modifications and variations of the present invention.

System of the invention adapted for use with a mechanical ventilator

Referring to fig. 7a1, step "D", an example of a particular main menu option for a mechanical ventilator will be described. If the caregiver has selected to check for the current protocol at step 50, the interface 14 provides various information to the caregiver (FIG. 7A 2). The care provider is informed of the tidal volume (tidal volume) (step 51); the respiration rate (step 52); a set high pressure (step 53); mode (step 54); peak flow (step 55); a set low pressure (step 56); PEEP level (step 57); elapsed time (step 58); last alarm (step 59). After providing this information to the care provider, step 14 returns to the main menu at step 60, as shown in FIG. 3.

Referring to fig. 7a2, the edit mode will be described in detail. If the caregiver has selected the edit mode at step 61, the interface 14 allows the caregiver to edit the current protocol. In this mode, some parameters may be maintained while others may be edited. The care provider is asked to enter the serial number of the mechanical ventilator (step 62), the care provider identification number (step 63), and the patient identification number (step 64). These numbers are for the purpose of keeping records and are included in any reports and documentation required by the care provider. The care provider is informed of the current tidal volume at step 65. The care provider is then asked to enter a new ratio or press the "#" key on the keypad to confirm the new ratio (step 66). Similar operations are performed on the breathing rate, the set high pressure, the mode, the current peak flow, the set low pressure, and the PEEP level (steps 67-78). After editing is complete, the interface 14 turns to the submenu of FIG. 7D (circle G).

Referring to FIG. 7D, the edit mode submenu provides the caregiver with some options after editing the protocol. The first edit mode sub-menu allows the care provider to send (i.e., save) the edit to the ventilator by pressing a particular key on the keypad (step 79), check the edit by pressing a different key on the keypad (step 80), and cancel the edit by pressing a different further key on the keypad (step 81). If the caregiver chooses to send the edit (step 79), a new protocol is sent to the ventilator (step 82), and the caregiver is exited. The caregiver is then transferred to the patient talking mode (step 83) and the caregiver connects with the patient to verify the programming (step 84). After verifying the programming change with the patient, the care provider suspends the remote phone (step 85) and the programming session ends.

If the caregiver chooses to check the edit (step 80), the interface 14 reports the new parameters of protocol 0 to the caregiver (step 86). After reporting, the care provider is taken to a second edit mode submenu, which originally allows the care provider to select: (1) send the edit (step 87), (2) edit the edit (step 88), or (3) cancel the edit (step 89). If the care provider chooses to send the modified protocol (step 87), a new protocol is sent to the ventilator (step 90), and the care provider is exited. The caregiver is then transferred to the patient talking mode (step 91) and the caregiver connects with the patient to verify the programming (step 92). After verifying the programming change with the patient, the care provider suspends the remote phone (step 93) and the programming session ends.

If the caregiver selects the create mode at step 94 (see FIG. 7A1), the caregiver is required to schedule various parameters for the new protocol. As shown in FIG. 7A2, the caregiver is asked to enter a tidal volume (step 95), and after the entered tidal volume is fed back, the caregiver is asked to press the "#" key to confirm. The care provider follows the same procedure to enter the respiration rate, set high pressure, mode, peak flow, set low pressure, and PEEP level (steps 96-101) and then returns to the same control menu as demonstrated in fig. 7D.

If the caregiver selects the fax reporting mode at step 102, the interface 14 generates a set of voice queries that are sent to the caregiver and provide the caregiver with options. Referring to FIG. 7B, step 103, the care provider may select a flow report, a stress report (step 104), or all reports (step 105). If the caregiver entered a number other than an option (step 106), the interface element returns to circle E. The care provider is then asked to enter a fax number for the location to which the report is to be sent in step 107. At step 108, the care provider may select a text report by pressing a certain button on a touch-tone keypad or a graphical report by pressing a different button (step 109). If the caregiver selects a text report, the caregiver may then choose to send a text report to the fax number each day by pressing a button on a touch-tone keypad at step 108 (step 110). If the caregiver chooses to request that the medical device remote system send a text report to the fax number daily, the caregiver then enters the time to send the report via the touch-tone keypad (e.g., 1430 for 2:30 PM) (step 111). If the caregiver selects a graphical report (step 109), the interface 14 asks the caregiver to select a sample time interval (in seconds) from 1 to 300 seconds (step 112). If the caregiver chooses to request that the medical device remote system send a graphical report to the fax number daily (step 113), the caregiver then enters the time to send the report via the touch-tone keypad (e.g., 1430 for 2:30 pm) (step 114). If the caregiver chooses not to require daily reporting, the caregiver will return to the main menu (step 115) whereby the graphical report will be sent to the fax number after the session is over.

If the caregiver selects the send file mode at step 116, the caregiver is turned to the send file menu (circle F) as in FIG. 7C. Step 117-. The care provider also has the option of having the medical device remote system send files to the remote computer on a daily basis (step 122-123).

System of the invention adapted for use with vital sign monitors

Referring to FIG. 8A, circle D, an example of a main menu option specific to when the medical device includes a vital signs monitor will be described in detail. Such a monitor typically acquires patient data such as blood pressure, body temperature, heart rate, oxygen saturation, carbon dioxide level, weight, and/or respiratory rate. If the care provider has selected to check for the current protocol at step 125, the interface 14 provides various information to the care provider. The caregiver is informed of blood pressure (step 126), body temperature (step 127), heart rate (step 128), oxygen saturation (step 129), carbon dioxide level (step 130), body weight (step 131), and respiratory rate (step 132). After providing this information to the care provider, the interface 14 returns to the main menu at step 133.

If the caregiver selects the fax reporting mode at step 134, the caregiver is directed to the fax reporting menu as illustrated in FIG. 8B. Upon accessing this menu, the interface 14 generates a set of voice queries that are sent to the care provider and provide the care provider with options. The care provider can select by pressing 1-8 on the touch-tone keypad (steps 135 and 142), respectively: (1) a blood pressure report, (2) a body temperature report, (3) a heart rate report, (4) an oxygen saturation report, (5) a carbon dioxide level report, (6) a weight report, (7) a respiratory rate report, or (8) all reports. The care provider is then asked to enter a fax number for the location to which the report is to be sent at step 143. At step 144, the care provider may select a text report by pressing a certain button on a touch-tone keypad, or a graphical report by pressing a different button (step 145). If the care provider selects the text report, the interface 14 tells the care provider to enter a certain number on the touch-tone keypad to suspend and end the session (step 146), whereby the text report will be sent to the fax number, or if the care provider wishes to return to the main menu, a different number (step 147), whereby the text report will be sent to the fax number after the session is ended. If the caregiver selects a graphical report (step 145), the interface 14 asks the caregiver to select a sample time interval (in seconds) from 1 to 300 seconds. If an invalid number is selected (step 149), the interface 14 returns to step 148. The care provider then enters a certain number on the touch-tone keypad to suspend and end the session (step 150) whereby the graphical report will be sent to the fax number, or if the care provider wishes to return to the main menu, a different number ("2" in this example) whereby the graphical report will be sent to the fax number after the session is ended (step 147).

Alternatively, the device 10 may store a fax number, and the device may be programmed to send a fax including the desired information at the specified time.

If the caregiver selects the send file mode at step 151, the caregiver is turned to the send file menu (circle F) as shown in FIG. 8C. Step 152- _ 163 is similar to step 135- _ 147 described above, except that the care provider must enter the sample time interval (step 160) and enter a computer telephone number instead of a fax number (step 161), whereby the report file is sent to the computer instead of the fax. In addition, the device 10 may be programmed to send e-mail via a communication network, such as the Internet. In this feature of the invention, the device will be programmed to record on the communications network, enter the password stored in memory, and send an email report.

In another aspect of the invention, as will be appreciated by those skilled in the art, the device may be programmed to ask the patient questions about how they feel, how painful, etc. Answers to these questions may be accessed by the care provider to assist the care provider in programming the protocol of the device. For example, if the patient indicates that he or she feels good, the care provider may not edit the protocol. This feature of the present invention allows the care provider to access more information and better care for the patient. The patient may enter their data through the device 10 itself, through a local telephone 48A, or in other ways, such as through a computer or the like. The patient may enter this data at any time when the status changes or is prompted, i.e., by a telephone call or an alarm on the device 10, at regular intervals.

According to the present invention, a medical system is provided that allows remote access and control of a medical device. The system is configured to allow a care provider to control the medical device from a remote telephone, computer or other transceiver. The care provider may obtain data from the medical device, such as in the form of a written report (e.g., by facsimile), by voice data, or by graphical or digital data provided to the computer (which may be represented as graphical or other data on a screen and/or stored in computer memory). The care provider may also program the medical device if the device stores programmable protocols. In addition, the system is configured such that the alarm signal from the medical device is also triggered remotely.

Specific examples of systems of the present invention that accommodate specific medical devices are described above. Those skilled in the art will appreciate systems that accommodate various other medical devices.

Having thus described the preferred embodiments of the present invention, it will, of course, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention as set forth in the appended claims.

Claims (9)

1. A remotely accessible medical device system, the medical device system comprising:

an electronically controllable medical device connected to the patient, the device configured to operate according to a programmable protocol and having patient data associated therewith, the medical device being at a first location with the patient;

a memory for storing programmable protocols and patient data;

a processor for manipulating the programmable protocol and the patient data;

a communication port, wherein the memory, the processor, and the communication port are located at the first location;

wherein the communication port is for allowing the processor to be connected to a public telephone network and when the processor is connected to the network, a particular telephone connected to the network at a second location remote from the first location may initiate communication with and be connected to the processor, the particular telephone and the network being components of the medical device system when the particular telephone is connected to the processor, and wherein all components of the medical device and the patient, except the particular telephone and the network, are located at the first location, thereby allowing the programmable protocol to be manipulated using a key signal generated by a key pad of the particular telephone and transmitted via the network, and further allowing checking of the number of patients sent from the memory to the particular telephone located at the second location over the network in response to a data access signal Whereby said data access signal takes the form of a key signal generated by said key pad of said particular telephone.

2. The medical device system of claim 1, further comprising a local communication port for connecting to a local telephone for transmitting data signals to and receiving signals from the local telephone.

3. The medical device system of claim 1, further comprising a connection button coupled to said processor, said button operable to activate said communication port to allow communication with said particular telephone.

4. The medical device system of claim 1, wherein an alarm algorithm is stored in said memory, said algorithm being used to detect alarm conditions for said patient data, said processor being used to establish a connection with a predetermined remote telephone and transmit said patient data to said predetermined remote telephone over said connection.

5. A method for providing health care to a patient from a remote location, comprising:

establishing a connection with a medical device associated with a patient using a telephone at a first location, the patient and the medical device system, except for the telephone and a communication network connecting the telephone with the medical device system, being at a second location remote from the first location;

receiving a menu query in the form of a stored voice signal, said signal containing a menu option for programming an operating protocol of a medical device connected to said patient;

selecting the option to program the operating protocol by sending a key signal over the network generated by a touch-tone keypad of the telephone;

modifying at least one parameter of the operating protocol by sending key signals generated by the key-operated keypad over the network;

saving the modified operating protocol; and

ending the connection with the medical device system.

6. The method of claim 5, further comprising the step of: the patient data stored in the memory of the medical device system is checked by sending a key signal from the telephone and receiving a voice signal from the medical device system at the telephone.

7. The method of claim 5, further comprising the step of: establishing voice communication with said patient between said patient's telephone at said second location and said telephone at said first location over said communication network without terminating said connection over said communication network.

8. The medical device system of claim 1, wherein manipulating said programmable protocol and reviewing said patient data can be accomplished by using only 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 0, # and # keys on said touch-tone keypad.

9. The method of claim 5, wherein said selecting step, said modifying step, and said saving step are accomplished using only 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 0, # and # keys of said touch-tone keypad.