Patent Application
20140162563
This invention relates to allowing secondary parties to monitor connectivity of medical devices, the invention further relates to notification of secondary parties if there is a connectivity failure between the medical device and a cloud based service or the secondary party and the cloud based service.
Over the years, bodily characteristics have been determined by obtaining a sample of bodily fluid. For example, diabetics often test for blood glucose levels. Traditional blood glucose determinations have utilized a painful finger prick using a lancet to withdraw a small blood sample. This results in discomfort from the lancet as it contacts nerves in the subcutaneous tissue. The pain of lancing and the cumulative discomfort from multiple needle pricks is a strong reason why patients fail to comply with a medical testing regimen used to determine a change in characteristic over a period of time. Although non-invasive systems have been proposed, or are in development, none to date have been commercialized that are effective and provide accurate results. In addition, all of these systems are designed to provide data at discrete points and do not provide continuous data to show the variations in the characteristic between testing times.
A variety of implantable electrochemical sensors have been developed for detecting and/or quantifying specific agents or compositions in a patient's blood or interstitial fluid. For instance, glucose sensors have been developed for use in obtaining an indication of blood glucose levels in a diabetic patient. Such readings are useful in monitoring and/or adjusting a treatment regimen which typically includes the regular administration of insulin to the patient. Thus, glucose readings improve medical therapies with semi-automated medication infusion pumps of the external type, as generally described in U.S. Pat. Nos. 4,562,751; 4,678,408; and 4,685,903; or automated implantable medication infusion pumps, as generally described in U.S. Pat. No. 4,573,994, which are herein incorporated by reference. Typical thin film sensors are described in commonly assigned U.S. Pat. Nos. 5,390,671; 5,391,250; 5,482,473; and 5,586,553 which are incorporated by reference herein, also see U.S. Pat. No. 5,299,571. However, the monitors for these continuous sensors provide alarms, updates, trend information and require sophisticated hardware to allow the user to program the monitor, calibrate the sensor, enter data and view data in the monitor and to provide real-time feedback to the user. This sophisticated hardware makes it most practical for users that require continuous monitoring with feedback to maintain tight control over their conditions. In addition, these systems require the user to be trained in their use, even if to be worn for short periods of time to collect medical data which will be analyzed later by a doctor.
Doctors often need continuous measurements of a body parameter over a period of time to make an accurate diagnosis of a condition. For instance, Holter monitor systems are used to measure the EKG of a patient's heart over a period of time to detect abnormalities in the heart beat of the patient. Abnormalities detected in this manner may detect heart disease that would otherwise go undetected. These tests, while very useful are limited to monitoring of bio-mechanical physical changes in the body, such as a heart beat, respiration rate, blood pressure or the like.
Uploading results of continuous measurement of a body parameter to a central database has also been undertaken. However, reliability of mobile data networks can introduce difficulties in regularly obtaining data Likewise, it would be beneficial if a third party could monitor the integrity of a mobile data network connecting a patient to a central database.
A system to monitor communications integrity is disclosed. The system includes a portable medical device having a medical device transmitter. The medical device transmitter is used to establish a medical device link that includes sending periodic data from the portable medical device. Further included in the system is a remote system with a remote system receiver to receive the medical device link. The remote system further including a remote system transmitter defined to establish a mobile device link. Further included is a mobile system having a mobile system receiver to receive the mobile device link from the remote system. The mobile device link periodically reports status of the medical device link to the mobile system. The mobile system further includes a plurality of alarm triggers associated with the integrity of the medical device link and the mobile device link.
Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, various features of embodiments of the invention.
A detailed description of embodiments of the invention will be made with reference to the accompanying drawings, wherein like numerals designate corresponding parts in the several figures.
Mobile data networks are enabling a wide array of data gathering that can be conducted in near real-time. In the mobile medical space, mobile data networks are enabling connected care where patients can upload physiological data in near real time without having to make a special trip to visit their physician or download data to a computer before sending it to a physician. Connected care also enables caregivers and family members the ability to more closely monitor physiological data gathered by sensors attached to mobile and remote patients. However, the reliability of mobile data networks and the patchwork of different data standards can result in spotty coverage and/or poor network performance.
Without operating an independent wireless data company it may be impossible to ensure a patient is within excellent mobile data network coverage. However, it is possible to determine the integrity of data connections between a portable medical system and a remote system. Furthermore, it is also possible to determine the integrity of a mobile data connection between a third party mobile device and the previously mentioned remote system.
In embodiments where the infusion pump 100 and the controller 106 communicate wirelessly, the controller 106 can be used to configure or program an associated infusion pump 100 to deliver a basal rate. Additionally, in some other embodiments the controller 106 can be used to program the infusion pump 100 to periodically remind a user via an alarm to deliver a bolus. Once the infusion pump 100 is programmed using the controller 106, the infusion pump 100 can execute the program without further interaction from the controller 106.
For example, using the controller 106 an infusion pump 100 is programmed to deliver a basal rate. Once programmed, the infusion pump 106 will deliver the basal rate without further input from the controller 100 until either a fluid reservoir 114 within the infusion pump 100 is exhausted via the basal rate, the power supply to the infusion pump 100 is exhausted, or another type of delivery failure. Thus, after the infusion pump 100 is programmed, the infusion pump 100 will execute the program independent of the controller 106. The controller 106 can be used to modify or augment the program of an infusion pump 100, however, the infusion pump 100 does not require continual or periodic updates from the controller 102 to execute a stored program.
Further included in the portable medical system 10 is an infusion set 102 that is coupled to the infusion pump 100 via tubing 108. The basal and bolus volumes delivered by the infusion pump 100 discussed above are delivered to a patient via the infusion set 102. In one embodiment the infusion set 102 includes a cannula 110 that is coupled to the tubing 108. In some of these embodiments the cannula 110 is positioned in the subcutaneous layer of the patient and a portion of the infusion set 102 remains outside of the patient's body. To prevent the cannula from falling out or moving some embodiments of the infusion set 102 include an adhesive layer to temporarily affix the infusion set 110 the skin of a patient.
The portable medical system 10 further includes a sensor assembly 104 that may be optional. In some embodiments the sensor assembly 104 is configured to wirelessly communicate with the controller 106 and/or the infusion pump 100. In particular embodiments the sensor assembly 104 includes a transmitter 112 that is coupled to a sensor 114. The sensor 114 can be defined to measure any number of physiological conditions and in one embodiment, the sensor 114 is defined to sense glucose concentration in interstitial fluid within the human body. In still other embodiments the sensor 114 is defined to sense glucose concentrations within the bloodstream. The transmitter 112 allows the signal generated by the sensor 114 to be transmitted to, in one embodiment the infusion pump 100, in another embodiment the controller 106, and in still another embodiment, both the infusion pump 100 and the controller 106.
The processor 200 executes program instructions stored in a memory 204. While memory 204 is shown as coupled to the processor 200 in
A transmitter/receiver 216 is coupled to the processor to enable the controller 106, also referred to as an RF programmer, to control various aspects of the infusion pump 100, in accordance with embodiments of the present invention. The transmitter/receiver 216 further enables the infusion pump 100 to wirelessly communicate with the sensor assembly 104. Data received from the sensor assembly 104 can be stored in the memory 204 for real-time or near-real time processing by the processor 200.
In still other embodiments the transmitter/receiver 216 found in either both or each of the infusion pump 100 and the controller 106 allows either the infusion pump 100, the controller 106 or both the infusion pump 100 and the controller 106 to transmit data such as, but not limited to, ongoing therapy, the condition of various aspects of the pump and the condition of the user based on data from the sensor assembly 104.
For simplicity, the controller 106 is shown as a single block. However, in various embodiments of the present invention the controller 106 can include infusion pump 100 elements such as, but not limited to, the processor 200, the memory 204, the display 206, the speaker 208 and the interface 212 along with vibration alarm 214 and bolus calculator 218. In embodiments where the controller 106 includes various infusion pump 100 elements, the infusion pump 100 may lack duplicate and redundant components to reduce costs and make the infusion system more affordable. However, in other embodiments, redundant systems can be found in both the controller 106 and the infusion pump 100 to minimize likelihood suspension of therapy due to failure of one element.
While the particular embodiment of the portable medical system 10 discussed above is directed toward an infusion system the scope of the claimed subject matter should not be construed as limited to infusion systems. Other portable medical systems such as pacemakers, stand alone glucose sensors, and other portable sensors for the measurement of biological or physiological conditions should be considered within the scope of this disclosure. Other portable medical systems such as, but not limited to, pregnancy monitors and portable ultrasound diagnostic equipment could also considered within the scope of this disclosure.
In some embodiments the medical device link 304 and the mobile device link 306 are wireless data connections. Exemplary embodiments of the wireless data connection that can be used for the medical device link 304 and the mobile device link include, but are not limited to cellular protocols commonly referred to as GSM or CDMA along with cellular data protocols commonly referred to as 3G (EDGE, EDGE Evolution, CDMA2000, EV-DO, UMTS, HSPA), 4G (WiMAX, LTE), along with other commonly used wireless standards such as Wi-Fi. Various combination of the communication protocols listed above can be used to establish both the medical device link 304 and the mobile device link 306.
Accordingly, in many embodiments the mobile device 300 is a commercially available mobile device having a user interface such as, but not limited to a mobile telephone, tablet, netbook, notebook or ultrabook with an appropriate radio transmitter and receiver. In some embodiments the mobile device 300 is running an application that enables usage of the appropriate radios to enable the mobile device link 306. Additionally, the mobile device 300 is configured to run an application that enables configuration and customization of settings and alarms. In specific embodiments where the mobile device 300 includes tactile alarms such as vibration alarms along with audible and visual alarms the various alarms can be configured separately and with escalating levels.
With the portable medical system 10 described regarding
In one embodiment the remote system 302 is a secure remote data repository. For example embodiments the remote system 302 are an evolution of the CareLink therapy management software for diabetes from Medtronic. The remote system 302 is configured to receive data from a plurality of portable medical systems via the medical device link 304. In one embodiment, the portable medical system 10 is programmed to periodically ping the remote system 302 via the medical device link 304. In other embodiments, data collected by the portable medical system can be periodically uploaded to the remote system 302 via the medical device link 304. For examples, in embodiments where the portable medical system 10 includes a physiological sensor the sensor data can be uploaded periodically or even substantially in real-time. In one embodiment the portable medical system 10 includes a sensor configured to measure glucose concentrations and the medical device link allows the upload of either sensor data or calculated blood glucose values directly into the remote system 302.
The remote system 302 can be programmed to receive periodic communications from the portable medical system 10 via the medical device link 304. For example, the remote system 302 could be programmed to receive either a ping or physiological data from the portable medical system every five minutes. In embodiments where near real-time data from a physiological sensor is being collected and analyzed the frequency of the transmission between the portable medical system 10 and the remote system 302 can be more frequent such as but not limited to every five to thirty seconds. In still other embodiments where a simple ping is used to verify the integrity of the medical device link the data transmission may occur every fifteen minutes to every hour. In still other embodiments combinations of periodic physiological data and data pings can be used to verify integrity of the medical device link 304.
In still another embodiment, the mobile device 300 is configured to periodically verify integrity of the mobile device link between the remote system 302 and the mobile device 300. In this embodiment the mobile device 300 is configured to periodically initiate communications with the remote system 302 via the mobile device link. In order to verify the integrity of the mobile device link the remote system 302 would acknowledge receipt of the communications back to the mobile device 300. As shown in
Operation 406 periodically transmits data from the portable medical system to the remote system. In some embodiments the periodic transmission from the portable medical system is analogous to a ping command where there is no acknowledgement from the remote system back to the portable medical device. In other embodiments the remote system is able to acknowledge receiving the periodic communication from the portable medical system. In still other embodiments where the portable medical system includes the ability to measure a physiological condition of a user, the periodic transmission may include patient data related to the measured physiological condition. For example, in embodiments where the portable medical system includes the ability to measure glucose concentration the periodic signal may include raw measured glucose concentration of calculated blood glucose values. Regardless of the particular embodiments of periodic transmission, operation 408 monitors transmissions from the portable medical system to verify the periodic transmissions are arriving according to a predefined schedule. Operation 410 verifies that the periodic transmission have been received by the remote system. If operation 410 determines a periodic transmission has been received from the portable medical device operation 408 is repeated. If operation 410 determines a periodic transmission has not be received by the remote system operation 412 sends a notification to the mobile device that the medical device link has been interrupted.
While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention. The embodiments discussed regarding infusion systems and glucose sensors should not be construed as restrictive. Any portable medical system that updates a remote system periodically or in real-time can benefit from the communication connectivity system described above. For example, it would be possible to include the connectivity verification system with medical systems such as pregnancy monitors, pacemakers, standalone glucose sensors and other portable sensors that measure biological or physiological parameters.
The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
