WO2005101276A2

WO2005101276A2 - Medical tele-monitoring system

Info

Publication number: WO2005101276A2
Application number: PCT/GR2005/000011
Authority: WO
Inventors: Alexandre Tsoukalis
Original assignee: Micrel Medical Devices S.A.
Priority date: 2004-04-13
Filing date: 2005-04-13
Publication date: 2005-10-27
Also published as: GR20040100128A; WO2005101276A3

Abstract

Minimal system to inform from distance tele-monitoring personnel on functional data of tele-medicine devices, using a momentary (communication closes after completion of package and eventually response) and simple point to point connection, which could also be a simple SMS message, using an updateable address book, where transferred medical data are adapted so that they ease the nurses on charge of patients at home, to supervise distant diagnostic and therapeutic devices, and avoid unnecessary visits. Special alarms for minimizing this cost are enumerated in the present patent. Especially, the pump can be programmed from other point, which can also be a mobile terminal.

Description

MEDICAL TELE-MONITORING SYSTEM

DESCRIPTION:

Prior Art.

It is known in the art, Micrel WO02082984, SARCOS Inc. EP 0846440, Gaukel

John US 6100806, to connect a therapy/diagnosis system via GSM+

UMTS/GPRS with a server, and from there to inform concerned parties with web, wap or SMS/MMS.

It is referred in the art, about infusion pumps with communication system to another point Arndt Heiko WO03068295 and Flaherty Christopher CA2423717 usually a programming the pump point, as well as sensors Von Czettriz

Gotthart US6577893 which send alarm when diagnosed parameters exceed some predetermined limit, over the Internet.

It is also known in the art point to point momentary connections with modem and PSTN telephone line Block Medical WO9616685, to a surveillance computer.

Point to point momentary connections have been used in camera surveillance systems (NOKIA).

The characteristic of all inventions above, are that the point to point communication is done with a single another point only, a server, monitor presenting data of sensors, or pump programmer, which does not solve the complex problem of Home Care as discussed later. I.e. there is a need for the pump to send copy of the communication to the server (if it exists), but it can be programmed directly from a mobile terminal without using the Internet, for safety and simplicity reasons, or to inform nurse in charge directly, possibly by

SMS, which may also make a minimal, without server network. The need to a minimal network comes from the lower cost if data are small, an independent network done from a Home Care Provider on his own, fear of information stolen from Internet.

To understand used terms such as "point to point" and "momentary connection" we need to categorize the connected parties. We usually have a patient at home, with therapeutic and diagnostic devices, a supervising nurse on the move on the street, a supervising mechanism in a static location which can be far from the patient. Nurses are changing shifts several times during a day/night.

A connection mobile terminal to mobile terminal is a point to point connection, while server emission to many receivers is a beam. Emission from mobile phone to server is point to point.

We name momentary a connection which ends soon after sending data. This is self understanding in SMS communication but not often in server communication. GPRS TCP/IP connections with a server generally are not momentary, but always open.

Programming an infusion pump is not generally safe to be done through IP

(Internet ) connections (hacking, viruses, bombardment with extensive use of the server to neutralize it) and we prefer peer to peer connections data, SMS, email for life support applications, like those done between mobile phones. So it is recommended to have at least another connection besides the server, or several connections without server.

In the present patent, there is a mechanism for managing and updating address book of contacts and priorities, the pump-diagnostic system is a different kind of server, for different contact points and different communication protocols

(TCP/IP & SMS) and this is improvement over prior art.

Existing infusion pumps, have characteristics and alarms which are good for a Hospital environment, but do not help on the complex environment of Home Care needing telemonitoring from distance.

The nurse is visiting the patient kilometers far from her, to change a drug reservoir, a battery, adapt infusion rate to evolving health conditions, so that patient does not feel pain (in PCA), or restore infusion after an alarm.

Nothing from these is correct to be done at night, as it increases the cost and nuisance to patients.

It is often today to have nurse visits at night for reasons described above.

Infusion of drugs with pumps has therapeutic and side effects. Measuring both, with implantable and extra-corporeal sensors, and monitoring therapy progress from distance, gives the opportunity to have automatic and semi-automatic infusion profile adjustment, with a doctor's digital signature, to increase therapeutic and reduce side effects. An infusion titration path risk analysis ends up often on the doctor's decision need. The present invention eases the implementation of this information, decision, and immediate infusion titration process, while keeping event log record with who did what information.

It is the aim of the present patent to provide a tele-monitoring system adapted to the needs to reduce cost, and nuisance of both the patients and medical staff.

It is also the aim of the present patent to provide a tele-monitoring system which informs managing and monitoring therapy personnel for every important data happening during therapy/ monitoring.

It is also the aim of the present patent to provide a tele-monitoring system which adapts therapy profile and monitoring parameter weighing factors to the automatic /semi-automatic decision function from distance.

It is also the aim of the present patent to provide a tele-monitoring system with minimum cost of mobile telephony and easy way to handle SIM cards.

Invention Description

The present invention preferably uses minimal, point to point momentary communication, between therapy/diagnostic system and monitoring personnel, but also classic communication with server, communication address book and procedure to update it, and communication priority list.

Communication may use means such as mobile terminal in any integration level

(IC-GSM placed inside tele-medicine device, OEM card GSM device, or full

GSM box, or mobile phone) or modem and PSTN line, or pager. Siemens,

Wavecom, Sony Ericsson and other companies have OEM mobile phones in form of card or chip.

These devices usually have GPS integrated, with which a nurse can understand where a patient is located, to visit him. Also using this information, a logistic system handling Home Care can be developed, automatically assigning material and services, to the patient's account. Technically this is feasible with minimum position difference in of two GPS, one of the telemedicine system and the one of the transporter. When this position identification happens, the transporter or nurse who has his own GPS, appears on the system as having arrived at the patient. When position with GPS is not feasible (like in towns and big buildings), a antenna triangulation positioning is available from most cellular service carriers.

At least Wavecom and Sony Ericsson have integrated TCP/IP protocol for easy GSM-GPRS /UMTS data connection with a server.

The service is SMS, MMS, GPRS, email, pager, or any other type of communication which arrives at the nurse on the move.

The waveforms of a sensor can be sent as images generated locally from raw data, and attached on an MMS message. So the doctor can receive directly from the patient's system an MMS with a cardiogram diagnosed locally as severe arrhythmia and he can decide what to do.

The above are working with other cellular telephony standards used in the US and Asia, 4 band cellular phones are a commodity today. The communication protocols at user layer and the address book, can be programmed on the microprocessor of the OEM card cellular phone with tools and operating system provided by the supplier. In this case, the medical part, i.e. data are provided from a serial port connection with the medical device. The mobile telephone acts as a local area network server, with serial or RF connection with the pump, or be integrated in the pump, and RF connection with other sensors as referred in the art. The inventive step here is in the evolution of the phone as a node of local communication with use of address book and protocol of updating them, and communication not only with one server but with many interested parties, using several communication paths (SMS, MMS, TCP/IP, email etc.)

Therapy system in present invention could be an infusion pump, or a pill handling system, releasing a pill at the right moment, and the diagnostic system could incorporate an ECG analyzer a pressure monitor, a pulse oximeter, a weighing scale etc. The diagnostic system could be in form of a chest belt, known in the art for athletes training, having 3 conductive rubber contacts, with the difference that in the present patent the ECG is analyzed using advanced diagnostic algorithms, issuing alarms in case of tachycardia, bradycardia, and some dangerous arrhythmias. For each arrhythmia, bradycardia or tachycardia, there are one or more limits, having different medical use. Some alarm, other just record the event for a statistical use. The belt incorporates means for transmission and battery in a full telemedicine system. Because cardiac diseases are often related to pulmonary ones, the belt can contain a reflective pulse oximeter using 2 or more LEDs and a photodiode, known in the art for measuring pressure of oxygen, and carbon dioxide; and the system so can also have limits on hypoxemia, hypercapnia. The pulse oximeter sensor may have the form of a behind the ear device, with optical part on the lobe. Alternatively, the diagnostic system can be a wrist bracelet, which measures at a time interval or on demand arterial pressure, in parallel with a pulse oximeter measuring blood flow initialization for pressure measurement as known in the art, but also saturation of oxygen, and pulse rate. The tightening the wrist system can be mechanical as a belt or pneumatic. From the pulse oximeter, uninterrupted work, we measure precisely cardiac rhythm, and from this, arrhythmias; bradycardia and tachycardia can so be detected. The artifact noise is rejected with special algorithms known in the art.

Preferred Embodiment

A preferred minimal embodiment is a therapy/ diagnostic system with internal or external telemetry system, which could be part of a mobile phone, in OEM card form, or chip, which sends and receives SMS /MMS messages from other mobile phones.

An infusion pump part of the said therapy/ diagnostic system in serial connection with the phone, sends through it information messages in SMS (or MMS or email) form, eventually on alarm event, or at regular intervals, or on demand as an answer to a call (unanswered) from shift nurse. Same is done from said diagnostic system, which monitors some medical health parameters. Diagnostic system connects to the said communication system, with a wireless local area network, as referred in the prior art. Low power consumption chip and special low power light communication protocol are used, some chips today have protocol in hardware (Nordic). The mobile phone of the nurse on shift to which shall be sent an eventual message, is updated in the memory of said therapeutic / diagnostic system via a call or a message from the nurse. That is, a new nurse on relaying shift, sends a non answered call and the nurse phone number is stored in FIFO memory, replacing previous shift nurse phone as SMS and MMS recipient. For more safety, the call may be a message with a code in it. The relay can also be done through the server to all patients' (communication systems) the nurse is in charge. More than one phone numbers can be put in lists, for doctor, and other interested parties.

Since the pump function and diagnostic means do not send continuously data, but on event, the connection can be momentary, as an SMS and so can be sent to more than one recipients.

The mobile therapy/diagnosis system can be programmed, configured and get limits to alarm/pre-alarm, get updated address book, from a PC, or SMS /MMS, email, GPRS data.

From the same route, a correction on programming, and all other parameters above can be made.

The server IP address and socket, APN -application server of the communication company, can be stored in the system's memory, via a PC or

SMS.

The mobile (SMS) updating of addresses and functional characteristics, has an advantage vis a vis PC use, to send update from distance, while a server is not possible to introduce a new SIM card, as on the mobile phone side, there is no information on which network to connect. Always on connections of prior art, have deficiency in this matter. We notice that SMS update of info can be also automated from the server when it has no other way to "find" the therapy/diagnostic system by lack of SIM card characteristics on the mobile side. This procedure is another inventive step over prior art.

In order to improve the Home Care Treatment efficiency, and reduce nuisance to the users, the system infusion pump, uses two new in the art alarms as below.

Several other alarms needed from medical standards, can be configured not to appear to the patient (even have no alarms at home) but only through the communication link to the assisting personnel. Medical standards need alarms for a number of cases. These alarms are good in a Hospital environment where nurses are around to take care, but at home, there is no aid, and a nurse has to travel long distance to arrive for help. In the present invention, and this is another inventive step, we can send these alarms to the right people, not to the patient who has to remain calm at home, while medical standards are followed.

So if the cellular communication is verified that the alarm arrived to the recipient a therapy watching person, possibly by an acknowledgement feedback, the alarm does not sound on the pump if it is so configured.

In Patient Controlled Analgesia, the patient asks with a handset the pump to deliver a bolus dose when he feels pain, so the consumption of drug is not predictable and not known in the prior art.

In present invention, we create alarms not appearing to the patient (the pump itself does not alarm) but to assisting personnel:

1. No Nuisance at night alarm: The pump calculates overall basal rate plus bolus delivery as mean rate of last hours, and calculates at what time it will end the remaining in the reservoir drug. If this occurs during the night, it emits alarm at the evening, so that nurse can change the reservoir before the night, and reduce nuisance and costs of both patient and nurse.

2. Pain alarm: The pump emits this alarm when pain level exceeds a limit programmed. Pain level is calculated as a Number of bolus asked % by the maximum bolus injections programmed in a certain period of time, usually an hour. This is a %No from 0 to infinite = given bolus*100/ limit bolus No. To explain this, we need to say that the pump has a limit of bolus per hour (actually a lockout time between bolus) known in the art. When patient asks more than the limit, the demand is recorded but the pump does not deliver. So more demands than deliveries (No >100%) is an indication of pain, while No<100 means analgesia. The number of hours for measuring pain alarm can also be programmed in the pump.

The limit to alarm can be programmed in the pump as needed by the doctor, to have an indication if analgesia is achieved. Because the pump is far away, the doctor does not have an indication of the pain treatment. The alarm gives this warning, so if it is possible, to increase the dose, and achieve analgesia. The dose can be adjusted over the air.

This alarm is received from the medical personnel also as a message with all infusion parameters, but is also written on the web server pump page. In prior art graphs of bolus asked versus bolus given are used to perceive pain levels. 3. Side effect alarm: An infusion has therapeutic and side effects. Diagnostic sensors ( which can also be biosensors even implantable), of the system on the patient, may watch both therapeutic symptom and side effect symptoms. Fall of oxygen levels or electroencephalogram frequency in PCA infusions, means overdose and infusion stops.

TPN infusions may produce hyperkalemia, and hypermagnesemia with arrhythmias, so TPN infusion stops and an alarm to therapy watching personnel is sent. Same in Epoprostenol (Flolan) infusion to people with primary pulmonary hypertension, not adhequate infusion rate may reduce blood oxygen levels, and people with this chronic disease can die.

When a therapy/diagnostic system receives a non answered call, it sends preferably SMS (or other communication types referred) the current infusion parameters and also diagnostic devices limits. So shift nurse can analyze data received, and may energize an application preferably Java J2ME on her mobile, with which can see and modify the infusion parameters (titration) just received from the pump, so the patient can have pain relief. New parameters can be sent in a form, which can be preferably SMS or email, as point to point to the SIM card of the pump, or TCP/IP packets initiated from J2ME application and passing through the connected server. For security, it is needed that the cycle ends by a confirmation of titration from the same or third route like watching therapy personnel or doctor, using a code.

Use of SIM cards without monthly fees, is more economic for the Home Care Provider, as he does not pay when card is not in use, knowing that a provider can have hundreds of devices in his warehouse.

Today's cellular phone OEM cards can talk to two or more servers at the same time, even send SMS without ending GPRS communication. We use this feature to have tele-medicine system talk to a device server on one location keeping a record of events and measurements, more for regulatory needs of a complex closed loop infusion control system, while talking also to a server with a client's application which needs some times to be integrated into client's computer system. The direct to nurse SMS in this case helps in cost assignment to one point (the SIM card of the telemedicine mobile system) and also avoid delays or discontinuities from a longer information path.

GLOSSARY:

GSM: Cellular phone service GPRS: Data always ON connection service on cellular phone known as 2,5 generation system

UMTS: Service of high speed data, always connected cellular telephony, enabling also video known as 3^rd generation

SMS : Short Messages Service over cellular telephony

MMS: Short messages including images and other files atached

PSTN: Standard ground based telephony

TCP/IP: Internet data integrity protocol

SIM card: a cellular phone interface card, which holds data and the Number of the phone used.

Server: It communicates with many devices bi-directionally, and also updates database of information received, and Internet pages dynamically

OEM: a module built by somebody to be integrated into another's product

LED: Light Emitting Diode

FIFO Memory: A memory first come first served

PCA: Patient Controlled Analgesia

PIN photodiode: special diode, photo-detector used in pulse oximeters.

Claims

CLAIMS:

1. Tele-medicine system incorporating mobile therapeutic and /or diagnostic means of medical parameters, and means communicating data bi- directionally to several other sites, characterized by a said momentary point to point communication, that is the communication ends after communication end, and which has an address book for clients, and protocol to update it, so it is possible to have sequential communication with several points.

2. Tele-medicine system as claim 1, where point to point communication may include momentary communication with a server.

3. Tele-medicine system as claim 1 or 2, where communication means are GSM or UMTS or i-mode telephony, and data are sent through SMS, MMS, e-mail or GPRS data.

4. Tele-medicine system as any preceding claim, where therapeutic means are an infusion pump of whatever type, syringe driver, peristaltic or other, which incorporates internally or externally communication means.

5. Tele-medicine system as ciaim4, where said pump emits special no nuisance at night alarm, calculated from mean liquid consumption the last hours, the remaining liquid in the reservoir, maximum programmed infusion Rate and the time difference till next morning.

6. Tele-medicine system as claim 4 or 5, where said pump emits pain level data, and especially alarm, where pain level exceeds a number, where pain level % is a number 0 to infinity, equal with asked bolus infusions per cent, by the maximum programmed bolus for the given patient for a certain time.

7. Tele-medicine system as any preceding claim, where a non answered call or SMS to said diagnostic / therapeutic system saves the calling telephone number or email address, as a new communication point, in a FIFO memory, and this memory makes an address book for next message communication recipients

8. Tele-medicine system as any preceding claim, where said therapy/ diagnostic system can be programmed for both initial programming, alarm levels and configuration values and consequent changes even in communication address book, from one or more of: a mobile phone, a server, a PC.

9. Tele-medicine system as any preceding claim, where position of the system / patient, detected by GPS integrated in the application and preferably in communication means, or detected from triangulation of antennas of cellular service provider, is transferred with communication, to facilitate logistic support of care.

10. Tele-medicine system as any preceding claim, where said diagnostic system is in the form of chest belt, incorporating battery and said communication means, having an ECG analyzer finding arrhythmias, abnormal ECG form, pulse rate, and emits alarms with associated event data of a cardiogram portion.

11. Tele-medicine system as any preceding claim, where said diagnostic/ therapeutic system is in the form of a bracelet, and measures arterial pressure and cardiac rhythm, using a pulse oximeter and mechanical or pneumatic tightening system and a pressure sensor, and arrhythmias from timing differences in the pulses and % oxygen saturation and carbon dioxide, while from said miniature communication means, it emits alarms.

12. Tele-medicine system as any preceding claim, where said pump may have no or fewer alarms appearing to the user, if successful communication transfer to assisting personnel via server or SMS is verified with acknowledgement.

13. Tele-medicine system as any preceding claim, where said diagnostic means, detect side effects of an infusion and then stop or reduce rate, and emit alarm.

14. Tele-medicine system as any preceding claim, where therapy/diagnostic system sends a copy of records to another server simultaneously.