HK1116032B - Ambulatory medical device and method of communication between medical devices - Google Patents

Description

Mobile medical device and method of communication between medical devices

Technical Field

The invention relates to an ambulatory medical device and a communication method for a medical device.

Background

Ambulatory medical devices for treating diabetes include, for example, extracorporeal insulin pumps and blood glucose measuring devices such as, for example, handheld glucose meters. Insulin pumps allow good control of blood glucose concentrations by continuously injecting basal amounts of insulin into the human body (basal insulin rate) and manually controlled additional "bolus" amounts of insulin to thereby reflect insulin secretion by the pancreas. Furthermore, the development of continuous glucose sensors will allow the measurement of glucose concentrations in vivo throughout the day. The measured glucose data can be used to adjust the diabetes therapy to the individual's need.

In order to improve the treatment of diabetes, it is important to provide an apparatus and method for transmitting data between medical devices in a quality-assured manner.

It is therefore an object of the present invention to provide a medical device and a method of controlled data transmission allowing for controlled data transmission between medical devices.

Disclosure of Invention

In a first aspect, the invention relates to a medical device comprising means for communicating with at least a second medical device, wherein the means for communicating within the medical device is adapted to be activated by a value of a physiological parameter of an animal.

The medical device of the invention preferably comprises a telemetry system for wireless communication, preferably a telemetry system for RF communication.

Preferably, the medical device is selected from the group comprising a remote control, a PDA, an analyte measuring device, preferably a glucose measuring device such as e.g. a hand-held glucose meter, more preferably a strip-based glucose meter or a combination thereof.

The physiological parameter is preferably selected from the group comprising analyte concentration, physiological characteristics like conductivity of the animal, physiological vital signs like heart rate or respiration rate, temperature, motion, air or structure borne sound, ECG (electrocardiogram) etc.

In a preferred embodiment of the invention, the analyte concentration is a blood glucose concentration.

Preferably, the medical device of the invention comprises an electrochemical or photometric module for measuring blood glucose. Suitable medical devices are, for example, strip-based glucose meters such as the AccuChek Compact.

In a second aspect, the invention relates to a system of medical devices. The system comprises a first medical device of the invention as described in the preceding paragraph and at least a second medical device capable of communicating with the first medical device.

In a preferred embodiment, the second medical device is selected from the group comprising an extracorporeal infusion pump, an implantable infusion pump, a regulator, an analyte or vital sign sensor, preferably a continuous analyte or vital sign sensor, more preferably a continuous glucose sensor.

In a further preferred embodiment, the first medical device and the at least second medical device comprise a telemetry system for wireless communication, preferably for RF communication.

In a third aspect, the invention relates to a method of communicating between a first medical device and at least a second medical device, wherein the communication between the medical devices is enabled and/or activated by a value of a physiological parameter of an animal.

In a preferred embodiment, the communication between the at least two medical devices is enabled and/or activated for a predetermined time. The duration may be fixed, random or dependent on the physiological parameter that enables and/or activates the communication or other physiological parameter of the animal body.

The physiological parameter is preferably selected from the group comprising analyte concentration, physiological characteristics like conductivity of the animal, physiological vital signs like heart rate or respiration rate, temperature, motion, air or structure borne sound, ECG (electrocardiogram) etc. Preferably, the analyte concentration is a blood glucose concentration.

In a preferred embodiment, the activation of the communication between the medical devices is performed on the first medical device by a value of the physiological parameter.

In a further preferred embodiment, the first medical device is selected from the group comprising a remote control, a PDA, an analyte measuring device, preferably a glucose measuring device, more preferably a strip based glucose meter.

The second medical device is preferably selected from the group comprising an extracorporeal infusion pump, an implantable infusion pump, a coordinator, an analyte sensor, preferably a continuous analyte sensor, more preferably a continuous glucose sensor.

In a preferred embodiment, the communication between the medical devices is a wireless communication, preferably an RF communication.

In a further preferred embodiment, the first medical device receives data from the second medical device.

In a further preferred embodiment, the first medical device sends instructions to the second medical device to at least partly control the function of the device.

Detailed Description

In one aspect, the present invention relates to a new method for controlling and/or enabling communication between medical devices, in particular medical sensing devices such as continuous glucose sensors and/or therapeutic devices such as insulin pumps and/or diagnostic medical devices such as glucose meters.

For example, communication between a continuous glucose sensor applied to the human body and a blood glucose meter may be established only when a blood glucose measurement has been made within the blood glucose meter. The generation of a blood glucose value within the blood glucose meter enables and/or activates a communication between the two devices for a specific time period. During this time window, data can be transmitted from the sensor to the glucose meter and/or instructions can be sent from the glucose meter to the sensor. After expiration of the time limit, the communication between the two devices is deactivated. In order to establish communication again, the communication link between the two devices must be activated by generating a further blood glucose value in the glucose meter.

The term "generating a value" as used herein includes any method or procedure for determining a physiological parameter, such as a method for measuring an analyte value, in particular a blood glucose value. Suitable methods for determining the blood glucose level are, for example, electrochemical and photometric methods known to the person skilled in the art.

The correlation of the communication link between the medical devices and the actual analyte values ensures the quality of the data transmitted from the medical sensing device and/or the medical treatment device to the medical diagnostic device.

The data transmitted from the sensor to the diagnostic device can be stored on the diagnostic device, e.g., a glucose meter, and transmitted to a third device, such as a PDA or computer, for further processing and/or analysis. By means of suitable software, the data can be analyzed and used for e.g. bolus recommendations or adjustments of basal insulin rates for the patient using an in vitro or in vivo insulin pump.

The communication link between the diagnostic device and a third device, e.g. a computer, does not need to be activated by generating a blood glucose value within the diagnostic device.

In a preferred embodiment, the invention relates to a method of communication between a diagnostic medical device, preferably a blood glucose meter, and an infusion pump, preferably an extracorporeal insulin pump. In this particular embodiment, the diagnostic medical device is used as a remote control to control the function of the infusion pump. After a blood glucose value has been produced in the blood glucose meter, the communication link between the meter and the pump is enabled and/or activated for a defined time, and instructions can be transmitted from the remote control, i.e. the glucose meter, to the pump. It is also possible to transmit data stored on the pump to the diagnostic device during the communication time window.

When the remote control of the infusion pump does not comprise a module for measuring the blood glucose concentration, the communication between the pump and the remote control is activated by entering the current blood glucose value measured in the blood glucose meter in the remote control. The value may be entered, for example, using a button of a remote control device, or may be transmitted via a wireless or wired connection to the glucose meter. After the blood glucose value has been entered in the remote control, the communication link between the remote control and the infusion pump is preferably established for a predetermined time frame. After the expiration of the time range, the communication is interrupted and data exchange between the two devices is no longer possible. A further round of communication is required by a new active communication by entering a new current blood glucose value in the remote control. The term remote control as used herein includes PDA, smart phone, portable and pump specific remote controls.

Data transfer between medical devices can be performed using known techniques and includes wired connections as well as wireless communications. These techniques are known to those of ordinary skill in the art. Preferred communications are wireless communications, more preferably RF communications.

Data transmission between devices can be encrypted to ensure that unauthorized third parties cannot obtain the patient's personal data. Methods of encrypting data are known to those of ordinary skill in the art.

In yet another preferred embodiment, the communication between the medical devices is activated by operating on a second medical device, e.g. an insulin pump, such as pressing a button or lever, inserting a battery, using a touch screen, shaking, bumping or squeezing, etc.

In the following paragraphs, preferred embodiments of the present invention are described.

A preferred system of medical devices comprises a continuous glucose sensor device and a glucose meter placed on the human body for measuring glucose values in interstitial fluid. The sensor device comprises an electrochemical glucose sensor that measures the glucose concentration in the interstitial tissue in a predetermined manner. The sensor device further comprises an extracorporeal part of the telemetry system comprising processor means for controlling the sensor, a memory for storing measured glucose values and means for transmitting data to a glucose meter, preferably a strip-based glucose meter. The glucose value stored on the sensor device is then transmitted to a glucose meter via a telemetry system.

The communication, i.e. the wireless link, between the two devices is established and/or activated by measuring the glucose concentration in the blood sample of the patient using a glucose meter, preferably a strip-based glucose meter. When using a strip-based glucose meter, the patient inserts the strip into the glucose meter and drops a drop of blood on the strip. The glucose meter measures and indicates on its display the blood glucose value. After measuring the blood glucose value, the communication link can then be activated/established by pressing a button on the glucose meter, e.g., an activation button, or by direct electronic linking to a processor controlling the glucose telemetry system such that completion of the blood glucose measurement automatically activates the wireless link between the devices.

A communication link is then established and data may be transferred between the medical devices for a defined time frame. After the expiration of the defined time range, the communication link is deactivated and it is no longer possible to transfer data/instructions between the medical devices. A new glucose measurement must then be made within the glucose meter to open a new wireless link between the medical devices.

In yet another aspect, the invention relates to a method of data processing or data use. The method is characterized in that the data processing or data usage is only possible after activation by the value of the physiological parameter. The method is preferably used for processing medical data such as data measured by sensors applied on the human body.

In a preferred embodiment, the method is used for processing medical data that has been measured by a sensor device applied on the human body, which is preferably a continuous glucose sensor. The data is then transmitted, for example, to a diagnostic medical device, preferably a blood glucose meter. The data is preferably transmitted from the sensor device to the diagnostic device via a wireless link. In this case, each of the at least two medical devices includes a telemetry system for wireless communication. The wireless communication may be bidirectional or unidirectional.

Preferably there is a permanent communication link between the two medical devices, but the data stored in, for example, the memory of the medical sensor device and transmitted to the diagnostic device can be processed further on the diagnostic device only after the processing has been activated by the value of the physiological parameter. The data stored in the memory of the diagnostic device can be processed or used after activation by the value of the physiological parameter, preferably the blood glucose value. For example, data is transmitted from a continuous glucose sensor to a glucose meter and stored in a memory of the glucose meter. It is then only possible to process these data even further after activation of the processing by the value of the physiological parameter, preferably the blood glucose value.

In a preferred embodiment, the processing of data is only possible for a limited time range after activation by the value of the physiological parameter. When the defined time range for data processing has elapsed, no further data processing is possible anymore without a new activation by the value of the physiological parameter.

In a further aspect, the invention relates to a medical device comprising a module for data processing adapted to be activated by a value of a physiological parameter. Preferably, the module comprises a microprocessor having a memory for storing data.

The medical device is preferably a blood glucose meter. Preferably, the processing of the data stored in the memory of the blood glucose meter is activated by pressing a button (activation button) on the glucose meter or by a processor electronically linked directly to the control data processing module/system such that completion of the blood glucose measurement automatically activates the data processing.

The terms "data processing" or "data usage" as used herein refer to any manipulation of data and includes analyzing data, representing data, interpreting data, and indicating data.

Claims (22)

1. A glucose measuring device comprising means for communicating with at least a second medical device, wherein the means for communicating with at least a second medical device within the glucose measuring device is adapted to be activated by the blood glucose concentration of the animal, wherein the blood glucose concentration enables and/or activates a communication between the glucose measuring device and the at least a second medical device for a specific time period, such that between said time periods data can be transmitted from the at least a second medical device to the glucose measuring device and/or instructions can be sent from the glucose measuring device to the at least a second medical device.

2. The glucose measuring device of claim 1, wherein the means for communicating with at least a second medical device is a telemetry system for wireless communication.

3. The glucose measuring device of claim 1 or 2, wherein the glucose measuring device is a strip-based glucose measuring device.

4. The glucose measuring device of any of claims 1-2, wherein the glucose measuring device comprises an electrochemical module for measuring blood glucose.

5. The glucose measuring device of any of claims 1-2, wherein the glucose measuring device comprises a photometric module for measuring blood glucose.

6. The glucose measuring device of claim 1, wherein the means for communicating with at least a second medical device is a telemetry system for RF communication.

7. A system of medical devices, comprising:

a) the glucose measuring device of any of claims 1 to 6, and

b) at least a second medical device selected from the group consisting of an extracorporeal infusion pump, an implantable infusion pump, an analyte sensor, capable of communicating with the glucose measuring device.

8. The system of claim 7, wherein the second medical device is a continuous analyte sensor.

9. The system according to claim 7 or 8, wherein the glucose measuring device and the at least second medical device comprise a telemetry system for wireless communication.

10. The system of claim 7, wherein the second medical device is a continuous glucose sensor.

11. The system according to claim 7 or 8, wherein the glucose measuring device and the at least second medical device comprise a telemetry system for RF communication.

12. A method of communicating between a glucose measuring device and at least a second medical device selected from the group consisting of an extracorporeal infusion pump, an implantable infusion pump, an analyte sensor, wherein the communication between the glucose measuring device and the second medical device is enabled and/or activated by the blood glucose concentration of the animal, and wherein the blood glucose concentration enables and/or activates the communication between the glucose measuring device and the at least second medical device for a specific time period, such that between said time periods data can be transmitted from the at least second medical device to the glucose measuring device and/or instructions can be sent from the glucose measuring device to the at least second medical device.

13. The method of claim 12, wherein communication is enabled and/or activated for a predetermined time window.

14. The method of claim 13, wherein the time window is established based on blood glucose concentration of the animal or based on a set of data obtained during a previous time period.

15. The method of any of claims 12 to 14, wherein the activation of the communication is performed on the glucose measuring device by generating a value of a blood glucose concentration within the glucose measuring device.

16. The method of any one of claims 12 to 14, wherein the glucose measuring device is a strip-based glucose measuring device.

17. The method of any of claims 12 to 14, wherein the second medical device is a continuous analyte sensor.

18. The method of any of claims 12 to 14, wherein the communication between the glucose measuring device and the second medical device is a wireless communication.

19. The method of any of claims 12 to 14, wherein the glucose measuring device receives data from a second medical device.

20. The method of any of claims 12 to 14, wherein the glucose measuring device sends instructions to the second medical device to at least partially control the second medical device.

21. The method of any of claims 12 to 14, wherein the second medical device is a continuous glucose sensor.

22. The method of any of claims 12 to 14, wherein the communication between the glucose measuring device and the second medical device is RF communication.