Patent ID: 12193782

DETAILED DESCRIPTION

With regard to fastening, mounting, attaching or connecting components of the present invention, unless specifically described as otherwise, conventional mechanical fasteners and methods may be used. Other appropriate fastening or attachment methods include adhesives, welding and soldering, the latter particularly with regard to the electronics associated with the invention, if any. Suitable electrical components and circuitry, wires, wireless components, chips, boards, microprocessors, receivers, transmitters, inputs, outputs, displays, control components, etc. may be used. Generally, unless otherwise indicated, the materials used in the invention and/or its components may be selected from appropriate materials such as metal, metallic alloys, ceramics, plastics, etc.

In one aspect, the present invention relates to a method for controlling and/or enabling communication between medical devices, such as medical sensory 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, referring toFIG.1, in one exemplary system2in accordance with the present invention, the communication between a continuous glucose sensor4applied to a human body and a blood glucose meter6can only be established when a blood glucose measurement has been made in the blood glucose meter6. The generation of the blood glucose value in the blood glucose meter6enables and/or activates communication, represented at arrow A, between the two devices for a specified time limit. During the time window data can be transferred from the sensor4to the glucose meter6and/or commands from the glucose meter6can be sent to the sensor4. After expiration of a time limit, communication between the two devices is deactivated. To establish a further or subsequent communication, the communication link between the two devices has to be activated by generating a further blood glucose value in the glucose meter6.

The term “generation of a value” as it is used herein encompasses any method or procedure for the determination of physiological parameters such as methods for the measurement of analyte values, e.g., blood glucose values. Suitable methods for the determination of blood glucose values include electrochemical methods, photometric methods and others which are known to a person skilled in the art.

The dependence of the communication link between medical devices on an actual analyte value ensures the quality of the data transmitted from the medical sensory device and/or medical therapeutical device to the medical diagnostic device.

The data transferred from the sensor4to the diagnostic device, e.g., the meter6, can be stored on the diagnostic device and be transferred, as represented by arrow B to a third device8such as a PDA or a computer, for further processing and/or analysis. The data can be analyzed and/or processed by suitable software and used, for example, for bolus recommendation or adjustment of basal insulin rates for patients using an extra- or intra corporal insulin pump. The communication link between the diagnostic device6and a third device8does not necessarily need activation by generation of a blood glucose value in the diagnostic device6.

Referring toFIG.2, in one preferred embodiment, the present invention relates to a method of communication between a diagnostic medical device10, e.g., a blood glucose meter, and an infusion pump12, e.g., an extra corporal insulin pump. In this embodiment, the diagnostic medical device10is used as or functions as a remote control to control the function of the infusion pump12. After a blood glucose value has been generated in the blood glucose meter10a communication link, represented by arrow C, between meter10and pump12is enabled and/or activated for a defined time and commands can be transferred from the remote control, i.e. the glucose meter, to the pump12. It is also possible to transfer data stored on the pump12to the diagnostic device10during the communication time window.

With further reference toFIG.2, in some embodiments comprising a remote controller14for the infusion pump12, the remote controller14may not comprise a feature or device for measuring blood glucose concentration. In such embodiments, the communication, represented by arrow C′, between pump12and remote control14is activated by entering a current blood glucose value measured in a blood glucose meter in the remote control14. The value may be entered using inputs of the remote control14or can be transferred via a wireless or wired connection to the glucose meter10. After the blood glucose value has been entered in the remote control14, a communication link between remote control14and infusion pump12is established, preferably for a predetermined time span. After expiration of the time span, the communication is interrupted and no data exchange between the two devices is anymore possible. A further round of communication needs a new activation of the communication by entering a new, current blood glucose value in the remote control14. The term remote control or controller as used herein encompasses PDA's, smart phones, pump specific remote controllers, etc.

The data transfer between the medical devices can be performed using known and/or available technologies, and may comprise wired and/or wireless components, connections and/or communications. These technologies are known to a person skilled in the art. In one preferred embodiment, communication may be provided RF communication. In some embodiments, the data transfer between the devices can be encrypted to ensure that non-authorized third parties do not gain access to personal data of patients. Any suitable method of encrypting data, including those known to a person skilled in the art, may be used. In some preferred embodiments, the communication between the medical devices may be activated by a manipulation of or on the second medical device, e.g. insulin pump12, such as pressing a button or lever, inserting a battery, using the touch screen, shaking, bumping or squeezing or the like.

Referring toFIG.3, in one preferred embodiment, the present invention comprises a system18of medical devices comprising a continuous glucose sensor device20which is placed on a human body to measure glucose value in interstitial fluid and a glucose meter22. The sensor device20comprises an electrochemical glucose sensor measuring the glucose concentration in the interstitial tissue in a predetermined manner. The sensor device20further comprises an extra-corporal part24including a suitable processor or computer26for controlling the sensor20, a suitable memory28for storing measured glucose values and a telemetry system or module30for transmitting the data to the glucose meter22, e.g., a strip-based glucose meter. The glucose values stored on the sensor device20may then transferred to a glucose meter22via the telemetry system30(as represented by arrows D and D′).

The communication between the devices, i.e. the wireless link, is established and/or activated by measuring the glucose concentration in a blood sample of a patient using the glucose meter22. When a strip-based glucose meter is used, the patient inserts a strip in the glucose meter and puts a droplet of blood on the strip. The glucose meter22measures and indicates the blood glucose value, e.g., on an associated display. After measurement of the blood glucose value, the communication link can then be activated/established either by, for example, pressing an input on the glucose meter22, e.g. an activation button, or by a direct electronic link to the processor26controlling the glucose telemetry system30such that the completion of the blood glucose measurement automatically activates the wireless link between the devices.

The communication link is then established and a data transfer between the medical devices is possible and/or occurs for a defined time span. After expiration of the defined time span the communication link is deactivated and no further data/commands can be transmitted between the medical devices. A new blood glucose measurement in the glucose meter22is then necessary to open a new wireless link between the medical devices.

In a further aspect, the present invention relates to a method of data processing or data use, wherein the data processing or data use is only possible and/or only occurs after activation by a value of a physiological parameter. The method is may be used for the processing of medical data such as data measured by a sensor applied on a human body.

Referring toFIG.4, in one preferred embodiment, the method in accordance with the present invention may be used for the processing of medical data sensed or measured by a sensor device34applied on a human being, e.g., a continuous glucose sensor. The data is then transferred, as shown by arrow E, to a diagnostic medical device36, e.g., a blood glucose meter.

The data may be transferred via a wireless link from the sensor device34to the diagnostic device36. In this case, each of the at least two medical devices comprises a telemetry system38for wireless communication. The wireless communication can be bidirectional or unidirectional.

In some preferred embodiments, there is a permanent communication link between said two medical devices, but the data stored in a memory39of the medical sensor device34and transferred to the diagnostic device36can only be further processed on the diagnostic device36after the processing has been activated by a value of a physiological parameter. After activation by a value of a physiological parameter, preferably a blood glucose value, the data stored in the memory39of the diagnostic device36can be processed or used. For example, data are transferred from a continuous glucose sensor34to a glucose meter36and stored in the memory of the glucose meter. The further processing of these data is then only possible after activation of the processing by a value of a physiological parameter, e.g., a blood glucose value. In one preferred embodiment, the processing of the data is only possible for a limited time span after activation by a value of a physiological parameter. When the defined time span for data processing has lapsed, no further data processing is possible without a new activation by a value of a physiological parameter.

Referring toFIG.5, in a further aspect the present invention may comprise a medical device40comprising a module, feature or component42for data processing which is adapted to be activated by a value of a physiological parameter. The module42comprises a suitable microprocessor or computer with a memory for storing data. In some preferred embodiments, the medical device40is a blood glucose meter. The processing of data stored in the memory of the blood glucose meter40may be activated either by pressing an input associated with the glucose meter40(e.g., an activation button or switch) or by a direct electronic link to the hardware, firmware and/or software of the data processing module42such that the completion of the blood glucose measurement automatically activates data processing. The terms “data processing” or “data use” as they are used herein refer to any manipulation of data and comprise analysis of data, presentation of data, communication of date, interpretation of data, indication of data, etc.

Embodiments of the present invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms and steps disclosed. The embodiments were chosen and described to provide the best illustration of the principles of the invention and the practical application thereof, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.