MEDICAL DEVICE HAVING CAPACITIVE COUPLING COMMUNICATION AND ENERGY HARVESTING
20180008770 · 2018-01-11
Assignee
Inventors
Cpc classification
H04B13/005
ELECTRICITY
A61M2205/8212
HUMAN NECESSITIES
A61M2205/3592
HUMAN NECESSITIES
A61M2205/3553
HUMAN NECESSITIES
A61M2205/8256
HUMAN NECESSITIES
A61M2205/3538
HUMAN NECESSITIES
A61M5/1723
HUMAN NECESSITIES
A61B5/14532
HUMAN NECESSITIES
A61M2205/3569
HUMAN NECESSITIES
A61M2205/52
HUMAN NECESSITIES
A61M2205/825
HUMAN NECESSITIES
International classification
Abstract
Provided is a wearable, self-contained drug infusion or medical device capable of communicating with a host controller or other external devices via a personal area network (PAN). The medical device utilizes a PAN transceiver for communication with other devices in contact with a user's body, such as a physiological sensor or host controller, by propagating a current across the user's body via capacitive coupling. The wearable nature of the medical device and the low power requirements of the PAN communication system enable the medical device to utilize alternative energy harvesting techniques for powering the device. The medical device preferably utilizes thermal, kinetic and other energy harvesting techniques for capturing energy from the user and the environment during normal use of the medical device. A system power distribution unit is provided for managing the harvested energy and selectively supplying power to the medical device during system operation.
Claims
1. A wearable medical device system for providing drug therapy to a user, the system comprising: a wearable medical device provided in contact with the user's skin, said medical device comprising a pump mechanism for administering a prescribed volume of a liquid drug to the user; and at least one bodily function sensor provided in continuous contact with the user's body, and further in communication with the wearable medical device; wherein the wearable medical device further comprises a microcontroller to control the prescribed volume of the drug according to physiological data received from the sensor, wherein the wearable patch pump and the sensor are at least partially powered by energy harvested from the user's body.
2. The medical device system of claim 1, wherein the sensor is contained in the wearable patch pump.
3. The medical device system of claim 1, wherein the sensor is implanted in the user's body and the sensor communicates with the wearable patch pump via a personal area network that uses the user's body as a transmission medium to transmit the physiological data.
4. A method for administering drug therapy to a user through a wearable medical device in contact with a user's body, the method comprising: providing a microcontroller electrically coupled to a pump mechanism, a transceiver and a power supply system; configuring the microcontroller to command the pump mechanism to administer a drug to the user; harvesting energy from the user's body; configuring the power supply system to selectively provide the harvested energy to the microcontroller, pump mechanism and transceiver; communicating with a host device on or near the user's body via a personal area network that transmits data across the user's body via the transceiver, wherein said host device monitors or controls the medical device and transmits data for at least controlling the administering of the drug to the user; and receiving at the medical device said data transmitted via the personal area network from the host device and controlling the pump mechanism to administer the drug to the user.
5. A wearable medical device in contact with a user's body for administering drug therapy to the user, the medical device comprising: a microcontroller electrically coupled to a pump mechanism and a transceiver, wherein: the microcontroller commands the pump mechanism to administer a drug to the user; and the transceiver communicates with a host device on or near the user's body via a personal area network that transmits data across the user's body, wherein said host device monitors or controls the medical device.
6. The medical device of claim 5, wherein the personal area network transceiver communicates to the host device via an electric field generated on the user's skin at a contact site of the medical device on the user's body.
7. The medical device of claim 5, wherein the medical device includes a patch pump for transdermally administering insulin to the user.
8. The medical device of claim 5, wherein the transceiver further communicates with at least one sensor implantable in the user's body, or in otherwise continuous contact with the user's body, via the personal area network.
9. The medical device of claim 5, wherein the transceiver further communicates with a temporary or disposable single use sensor, via the personal area network.
10. The medical device of claim 5, further comprising at least one sensor electrically coupled to the microcontroller.
11. The medical device of claim 5, wherein the transceiver further communicates with a plurality of sensors via the personal area network.
12. The medical device of claim 5, wherein the microcontroller comprises an ultra-low power microcontroller.
13. The medical device of claim 12, wherein said ultra-low power microcontroller operates in a range up to 3.6 V.
14. The medical device of claim 13, wherein said ultra-low power microcontroller further consumes no more than 20 microamperes of current in a standby mode and 20 milliamperes of current in an active mode.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The above and other exemplary features and advantages of certain exemplary embodiments of the present invention will become more apparent from the following description of certain exemplary embodiments thereof when taken in conjunction with the accompanying drawings, in which:
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[0027] Throughout the drawings, like reference numerals will be understood to refer to like elements, features and structures.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0028] The matters exemplified in this description are provided to assist in a comprehensive understanding of exemplary embodiments of the invention, and are made with reference to the accompanying figures. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the exemplary embodiments described herein can be made without departing from the scope and spirit of the claimed invention. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
[0029] A general embodiment of the wearable medical device 100, constructed in accordance with the present invention is illustrated in
[0030] As shown in
[0031] One of ordinary skill in the art will appreciate that medical device 100, shown in
[0032] A first exemplary embodiment of medical device 100 in accordance with the present invention is illustrated in
[0033] Microcontroller 104 in the first embodiment of the present invention is provided at least for controlling pump mechanism 102. Microcontroller 104 is preferably an ultra low-power (ULP) programmable controller, ideally operating in a range up to 3.6 V, which combines the necessary processing power and peripheral set to control drug delivery through the pump mechanism 102, monitor an optional sensor 300, and control any communication requirements for communicating with the host device 200. The first exemplary embodiment of the present invention provides a “smart” medical device that is capable of communicating with host device 200 via transceiver system 106. Microcontroller 104 is preferably fully programmable by the host device to precisely control the user's basal infusion rate and necessary bolus injections. Further, host device 200 can control microcontroller 104 to activate pump mechanism 102, perform system diagnostics, monitor system parameters of medical device 100 and record infusion data and other information communicated from medical device 100. Microcontroller 104 in the first embodiment is preferably embodied in a “system on a chip” (SoC) including the circuitry for the transceiver system 106. SoC designs usually consume less power and have a lower cost and higher reliability than the multi-chip systems that they replace. By providing a single chip system, assembly costs may be reduced as well.
[0034] Transceiver system 106, provided in medical device 100 in the first embodiment of the present invention, is compatible with the transceiver at the host device 200 and any other peripheral units such as optional bodily function sensor 300 in order to communicate with each device. As discussed above, in a “smart” medical device of the first embodiment, transceiver system 106 is provided for communicating at least system diagnostic data, infusion rate or infusion schedule information to host device 200 or some other external device. Additionally, transceiver system 106 receives commands and data from host device 200 enabling the programming of microcontroller 104 and control of other system functions of medical device 100. Diagnostic data can refer to any information about the functionality of the medical device and its system components, such as whether the cannula is blocked or otherwise rendered unusable, the remaining volume of liquid medicament available, and the remaining power available for controlling the medical device 100.
[0035] Conventional “smart” medical devices currently use radio frequency (RF) wireless communications such as Bluetooth®, Zigbee®, 802.11, or other conventional solutions. Some medical devices even communicate with the host device via a line-of-sight using infrared (IR) technology. Wireless communication systems, since they do not require a line of sight, are preferred over IR technology. Conventional wireless technology, however, is a driving contributor in the prohibitive cost of medical devices that use their respective technologies. Conventional wireless systems require an RF transceiver and antenna to operate. Advantageously, exemplary embodiments of the present invention use a capacitively coupled personal area network (PAN) to transceive data between medical device 100 and host device 200 through the user's skin, without the use of antennas. A personal area network, in the exemplary embodiments, can be created with simple, low-cost microcontrollers and analog components, requires less power to operate than RF systems and are at least as secure as RF systems. The use of a personal area network in the exemplary embodiments reduces the overall cost for device/host communications and enables extended use duration due to the reduced component cost and lower power requirements. As previously discussed, an exemplary PAN transceiver system 106 is preferably packaged in a SoC design with microcontroller 104 for further minimizing the overall cost of medical device 100.
[0036] PAN transceiver 106 preferably establishes a personal area network to communicate with host device 200 via a “near field” electric field that transmits data using the human body as a transport medium. Medical device 100 and host device 200 each need PAN transceivers 106 and 206, respectively, in order to communicate to each other through the body. In an exemplary personal area network as illustrated in
[0037] The above PAN communication system ensures that only people in direct contact with a user are capable of detecting the signals propagating across the user's body. Alternatively, in conventional wireless technologies, a transmitted signal can be detected by anyone with a receiver in the respective range of the wireless technology. Transmitters and receivers using Bluetooth® can transceive signals in a range from 30 ft. to 100 ft. Thus, PAN communication techniques are inherently more secure. However, additional techniques are desirable for coding and encrypting the transmitted current so that a user's private medical information cannot be detected or deciphered by anyone who comes into contact with the user. Coding techniques for preventing cross-talk between PAN devices is desirable so that a husband and wife, or other acquaintance, using PAN devices can hold or shake hands without influencing the data communication of either user's personal area network. Additionally, the signal transmitted across the user's body can be further encrypted so that any information transmitted by bodily contact will be unintelligible to unauthorized recipients. The specific techniques and methods for coding and encryption are not specific to the present invention. Any high reliability/low error version of a standard multi-user across single channel networking protocol, such as TCP/IP, can be effectively implemented in exemplary embodiments of the present invention. For instance, suitable handshaking techniques/protocols and encryption key management and algorithms for use in exemplary embodiments of the present invention may be similar to those currently used in Bluetooth® and Wi-Fi networks. It would be appreciated by one of ordinary skill in the art, that the particular coding and encryption techniques implemented in the exemplary embodiments of the present invention, while similar to those techniques discussed above, may be provided in a lighter, less complex protocol.
[0038] The necessary transceiver components for realizing the functionality of the exemplary personal area network discussed above, are widely available and relatively low in cost. Additionally, transceivers 106 and 206 can be realized in a single integrated circuit or included in the SoC design discussed above, which is even cheaper to produce and will consume even less power.
[0039] Analysis of a conventional medical device showed a typical steady state current usage of up to 15 mA while performing RF communications. Since an exemplary personal area network of the present invention transmits data using an ultra-low current signal propagating on the user's skin, data transfer can reasonably be achieved with 30 nA of current. Associated circuitry required to amplify and digitally acquire the data from the received electric signal could require up to 1 mA of additional current, thereby still achieving a factor of 10 reduction in power consumption for communications. Implementation of an exemplary PAN communication system in medical device 100 and host device 200, effectively realizes a significant decrease in power consumption for the device, thus resulting in less expensive, fewer or smaller power components for supplying the power necessary for system operations. A reduction in power requirements achieves an overall reduction in cost for the medical device 100 and reduces the number or size of power components, thus also reducing waste. Further, the low power requirements of the PAN communication system as well as the wearable nature of medical device 100 enable medical device 100 to utilize alternative energy sources for powering the device.
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[0041] An exemplary embodiment of power system 108 utilizes a temporary storage circuit or device for storing the harvested charge until it is supplied to power a system component of medical device 100, such as PAN transceiver 106. An exemplary embodiment of the present invention utilizes an ultracapacitor as storage unit 114 to store the harvested energy. Ultracapacitors are advantageous because of their high energy density and quick charging times, thus providing a suitable option for powering the systems of an exemplary medical device 100. It should be appreciated by one of ordinary skill in the art, that storage unit 114 may comprise any temporary storage component, circuitry or technique that is known in the art, and is not particularly limited to an ultracapacitor. Power distribution unit 116, may comprise a power management circuit or other known component for providing the necessary power requirement from power storage unit 114 to each system device.
[0042] An exemplary embodiment of power system 108 in medical device 100 preferably comprises a single power source such as energy harvesting component 112, capturing, for instance, thermal or kinetic energy from the user's body and the user's natural movement. In an exemplary embodiment of the present invention comprising ultra low-power microcontroller 104 and low-power PAN transceiver system 106, a single energy harvesting source may be sufficient for providing the complete power requirements for medical device 100. Additionally, a single energy harvesting source may necessarily provide sufficient power for medical device 100 in embodiments that use a preprogrammed microcontroller 104 and do not provide a communications transceiver system. The power supplied to medical device should be sufficient for enabling operation of the medical device in an active mode and a standby mode. In the standby mode, the microcontroller preferably consumes about 10 microamperes of current but no more than 20 microamperes. In the active mode, the microcontroller preferably consumes about 10 milliamperes but no more than 20 milliamperes.
[0043] In some embodiments, power system 108 may additionally comprise a battery 118. Battery 118 may comprise any one of well known power storage units, or an array of such units, known in the art including, but not limited to, standard alkaline cells, rechargeable cells and ultracapacitors. In such embodiments, power distribution unit 116 can optimally manage the distribution of power from the battery 118 and the energy harvesting storage unit 114 to provide increased performance and extended life of medical device 100. One embodiment of medical device 100 would use battery 118 for long-term storage power or “off” mode, and in an active mode, such as during a high-discharge time for pump mechanism 102 to dispense a drug to the user. Harvested energy storage unit 114 is then preferably used to supplement the idle/standby mode of medical device 100, which has been shown in some systems to be the highest overall power drain to the system. By utilizing energy harvesting as the sole or partial power source for an exemplary embodiment of medical device 100, the device life could be extended or the battery requirements be reduced, thereby increasing performance and reducing cost in comparison to existing patch pumps.
[0044] Another embodiment of power system 108 for use in exemplary embodiments of the present invention is illustrated in
[0045] In the embodiment illustrated in
[0046]
[0047] One of ordinary skill in the art would appreciate that the features of the above exemplary embodiments may be similarly provided in a number of applications and are not limited to the above disclosure. Any other skin-surface, wearable, implantable and handheld devices can all utilize the above features and techniques for providing a body based personal area network of complex, low-power devices at minimal cost. In addition to the insulin patch pump devices disclosed herein, other non-pump insulin infusion devices for patients of varying needs can be implemented with the above discussed features, such as a programmable insulin pen device or a controller in combination with an insulin absorption patch or electrosensitive gel patch. Additionally, other physiological information such as systolic pressure, heart rate and other metrics can all be monitored and captured via a respective device using the exemplary personal area network. Similarly, implantable defibrillators and other devices can all be controlled from a single master/host device. An exemplary personal area network can theoretically support many more than just two or three devices. Such network can also be used to communicate to any stationary devices when the user makes physical contact with them. One embodiment could provide automated data transmission such as populating patient records stored in a handheld or wearable device when touching a computer fitted with a compatible PAN transceiver. Another embodiment could provide emergency personnel with immediate data concerning a patient's physiological functions just by making skin to skin contact to establish a communications link between compatible devices on each person. As discussed above, each of these embodiments can be implemented in a secure PAN, so as to ensure user privacy and security of sensitive medical information.
[0048] While the present invention has been shown and described with reference to particular illustrative embodiments, it is not to be restricted by the exemplary embodiments but only by the appended claims and their equivalents. It is to be appreciated that those skilled in the art can change or modify the exemplary embodiments without departing from the scope and spirit of the present invention.