Patent Application
20180153450
A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright rights whatsoever.
The disclosure relates generally to the field of sensors, therapy devices, implants and other devices (such as those which can be used consistent with human beings or other living entities for in vivo detection and measurement or delivery of various solutes), and in one exemplary aspect to methods and apparatus enabling the use of such sensors and/or electronic devices for, e.g. monitoring of one or more physiological parameters, including through use of external receiver and processing apparatus.
Implantable electronics is a rapidly expanding discipline within the medical arts. Owing in part to significant advances in electronics and wireless technology integration, miniaturization, performance, and material biocompatibility, sensors or other types of electronics which once were beyond the realm of reasonable use in vivo in a living subject can now be surgically implanted within such subjects with minimal effect on the recipient subject, and in fact many inherent benefits.
One particular area of note relates to blood glucose monitoring for subjects, including those with so-called “type 1” or “type 2” diabetes. As is well known, regulation of blood glucose is impaired in people with diabetes by: (1) the inability of the pancreas to adequately produce the glucose-regulating hormone insulin; (2) the insensitivity of various tissues that use insulin to take up glucose; or (3) a combination of both of these phenomena. Safe and effective correction of this dysregulation requires blood glucose monitoring.
Currently, glucose monitoring in the diabetic population is based largely on collecting blood by “fingersticking” and determining its glucose concentration by conventional assay. This procedure has several disadvantages, including: (1) the discomfort associated with the procedure, which should be performed repeatedly each day; (2) the near impossibility of sufficiently frequent sampling (some blood glucose excursions require sampling every 20 minutes, or more frequently, to accurately treat); and (3) the requirement that the user initiate blood collection, which precludes warning strategies that rely on automatic early detection. Using the extant fingersticking procedure, the frequent sampling regimen that would be most medically beneficial cannot be realistically expected of even the most committed patients, and automatic sampling, which would be especially useful during periods of sleep, is not available.
Implantable glucose sensors have long been considered as an alternative to intermittent monitoring of blood glucose levels by the fingerstick method of sample collection. These devices may be fully implanted, where all components of the system reside within the body and there are no through-the-skin (i.e. percutaneous) elements, or they may be partially implanted, where certain components reside within the body but are physically connected to additional components external to the body via one or more percutaneous elements.
Accuracy is an important consideration for such implanted analyte sensors, especially in the context of blood glucose monitoring. Ensuring accurate measurement for extended periods of time (and minimizing the need for any other confirmatory or similar analyses) is of great significance.
Devices such as the Dexcom G5 utilize peroxide-based blood glucose sensing, including a requirement for frequent external calibration (i.e., utilizing a separate confirmatory test such as a fingerstick). Per the manufacturer, the device should be calibrated at least once every twelve (12) hours via fingerstick or blood glucose (BG) meter, thereby making the device somewhat burdensome for the user in everyday operation (aside from issues associated with the transcutaneous sensor probe 103 and the associated requirement to continuously wear the device 102 externally on the abdomen).
Moreover, the receiver apparatus 108 must be kept in wireless proximity of the user (and the device 102) at all times; without the external receiver 108 and its display/alert features, the user has no way of being informed of their blood glucose level at any given time (or potentially dangerous situations such as rapid drops or increases in blood glucose level). While the maximum wireless range of the exemplary G5 device is generally commensurate with that of other Bluetooth-enabled devices (e.g., typically on the order of 30 feet or so), and hence gives some degree of flexibility to receiver placement relative to the user (and the sensor device 102), there are significant disabilities with this scheme, including notably the inability for the user to engage in some activities which require dissociation of the user (and device 102) from the receiver due to distance, an intervening and interfering medium such as water, etc., or incompatibility of the receiver with such media. Moreover, such receivers can add significant weight and/or bulk to the user when affixed thereto, thereby potentially reducing their competitiveness in high-end sporting activities such as marathons, gymnastics, triathlons, bicycle racing, etc.
Hence, in essence, a user of such prior art systems must have their receiver (dedicated or smartphone) with them at all times, and the system is unforgiving for transgressions of this requirement. For instance, a user leaving for work in the morning who forgets their smartphone or receiver at home has little choice but to turn around and retrieve it (unless they happen to keep a “spare” at the office).
Potential failure of such equipment (whether due to equipment failure, loss of battery charge, etc.) also requires some degree of “planning ahead” for the user including e.g., making sure that their receiver or smartphone is charged sufficiently, and/or a backup exists in case their receiver/smartphone is damaged or otherwise disabled.
The Assignee of the present disclosure has more recently developed improved methods and apparatus for implanting a blood glucose sensor (and measuring blood glucose level using the implanted sensor), which overcome the aforementioned disabilities with the prior art; see, inter alia, U.S. patent application Ser. Nos. 13/559,475, 14/982,346, 15/170,571, 15/197,104, and 15/359,406 previously incorporated herein.
However, Assignee has further recognized that one area of significant potential improvement relates to the external device “burdens” placed on a user, described above; i.e., making any external apparatus that the user must possess or utilize, and with which the user must interface, as minimal and user-transparent as possible, and reliable as possible, is highly desirable.
Moreover, user body (self) image, and perception of the user by others, are each of great significance to some individuals. Generally speaking, the less salient and more unobtrusive such users' blood analyte monitoring apparatus (and communications emanating therefrom) are, the more likely such users will continue to utilize the apparatus for their monitoring needs, and the less likely they will be to feel inhibited from participating in certain social situations.
The present disclosure satisfies the foregoing needs by providing, inter alia, improved apparatus for receiving sensed analyte levels within a living subject, including for extended periods of time without access to a smartphone or other comparable device, and methods of manufacturing and operating the same.
In one aspect of the disclosure, an apparatus for use with an implantable blood analyte sensing device is disclosed. In one embodiment, the apparatus includes a small form-factor electronic device which can be unobtrusively worn by the user on a continuous or near-continuous basis, and which can at least: (i) wirelessly receive signals from the implanted sensing device, and (ii) generate an output cognizable to the user relating to the sensed analyte level.
In one variant, the apparatus comprises an environmentally and mechanically robust wrist-band configured to generate a visual output (e.g., digital representation of blood glucose level in mg/dL or mmol/L). Alternatively, the apparatus may take the form of a neck pendant, badge or patch that can be temporarily affixed to the user's clothing, hair accessory, eyeglass/sunglass frame, or yet other personal accessory.
In another variant, the apparatus communicates with the user via a haptic device in contact with their skin, so as to e.g., indicate alerts, or even encode the blood glucose levels via haptic output.
In one implementation, the apparatus is configured to appear generally consistent with the appearance of a similar extant device (e.g., sports or cross-fit type wrist-worn physiological monitor), so as to appear to others that the user is merely wearing the extant device, versus a blood analyte data receiver.
In another implementation, the blood analyte display/haptic functionality is merely incorporated into the extant device, such as via a firmware upgrade and inclusion of an appropriate wireless interface and processing logic, or added onto the extant device via an add-on module (e.g., which snaps onto or adheres to the extant device).
In a further implementation, the apparatus includes a band (e.g., wrist band) for retention of the apparatus on the user, the band also comprising one or more radio frequency antenna elements therein.
In a further variant, the apparatus comprises an ear bud or ear plug which communicates with the user via audible output. In one implementation, the ear bud or plug is configured for wireless data communication with the implanted sensor and is battery powered, and the audible output comprises a synthesized voice readout of the numerical value of blood glucose level or other information of interest. In another implementation, the audible output comprises a series of discrete tones which encode the numeric value, and/or which are indicative of one or more alerts or action items for the host.
In yet another variant, the apparatus includes a substantially flexible patch which can be adhered to e.g., the user's skin. The patch in one implementation includes electronic circuitry printed on a substrate of the patch, and miniature integrated circuit (IC) devices embedded therein, as well as a flat or flexible LED (e.g., graphene-based), AMOLED, or OTFT (organic thin-film transistor) display device which is configured to display desired information such as analyte concentration in the wearer's blood based on received signals transmitted from the implanted sensor. In an exemplary configuration, the patch is powered by a flexible triboelectric or “static electricity”-based generator, and is kept in a dormant state except when the user desires to observe the display, and/or when the wireless receiver of the patch must be powered on to receive modulated RF signals from the implanted sensor.
In yet another variant, the apparatus includes a passively powered (i.e., by incident electromagnetic energy) patch which can be adhered to the subject's skin, clothing, etc., and which utilizes received RF energy from the implant transmitter (or another source) to demodulate the incoming RF signal, unscramble it, extract the data from the demodulated and unscrambled signal, process the extracted data, and cause illumination of one or more light sources (e.g., ultra-low power LEDs) on the patch indicating the estimated analyte level.
In one implementation of the foregoing “patch” variants, the patches are sold as a disposable commodity; e.g., a pack of twenty (20) which can be individually utilized by the user when a predecessor patch requires replacement due to loss, damage, or merely normal wear and tear.
In yet a further variant, the apparatus comprises an implant which is used to receive signals transmitted from the implanted analyte sensor, and produce an output indicative of analyte level cognizable by the host. In one implementation, the implant comprises a dental implant with radio frequency receiver and an acoustic transducer, and is configured to receive RF transmissions from the implanted sensor at a prescribed frequency, demodulate and extract sensed analyte data, process the data, and generate a host-audible output relating to the analyte level (e.g., via transmission to the host's auditory system via the host's jawbone).
In another aspect of the disclosure, a method of operating a blood analyte sensing system is disclosed. In one embodiment, the system includes an implantable analyte sensor, and an external reduced-capability receiver apparatus, and the method includes utilizing only the receiver apparatus for informing the host of the measured analyte level for a prescribed period of time, without resort to any other external calibration mechanism or input (whether via the receiver apparatus or otherwise). In one variant, the prescribed period of time comprises one (1) week.
In a further aspect, apparatus for use with an implanted blood analyte sensing device is disclosed. In one embodiment, the apparatus includes: wireless receiver apparatus configured to receive wireless signals from the blood analyte sensing device, the wireless signals encoding data relating to levels of the blood analyte; data processing apparatus in data communication with the wireless receiver apparatus and configured to utilize the encoded data to determine a blood analyte level; an electrical power source configured to supply electrical power; and indicator apparatus in communication with the data processing apparatus and electrical power source, the indicator apparatus configured to indicate to a user the determined blood analyte level.
In one variant, the implanted blood analyte sensing device includes at least one oxygen-based sensor, and the apparatus is configured to operate without communication with a parent platform or external calibration for at least a prescribed period of time (e.g., one week).
In another variant, the wireless signals encoding data are scrambled according to a unique scrambling code prior to transmission from the device, and the apparatus is further configured to unscramble the received wireless signals based at least in part on the unique scrambling code. The wireless signals are transmitted from the device e.g., only at prescribed times or prescribed intervals, and the apparatus is configured to enable the wireless receiver apparatus to receive the wireless signals only during the prescribed times or at the prescribed intervals, and otherwise maintain at least a portion of the wireless receiver apparatus in a dormant or sleep state so as to conserve electrical power of the electrical power source.
In a further variant, the wireless signals are transmitted from the device only at prescribed times, and the apparatus is configured to enable the wireless receiver apparatus to receive the wireless signals during a number n of the prescribed times, the number n less than a total number of transmissions of the wireless signals, the apparatus configured to dynamically vary the number n based at least on one or more operational parameters, such as e.g., a remaining level of power in the electrical power source, a time period from when a last prior calibration was applied to the data relating to levels of the blood analyte, or the determined blood analyte level, and/or detection of an ambulatory or non-ambulatory state of the user.
In another variant, the apparatus is further configured to utilize at least the data relating to levels of the blood analyte to determine at least one of: (i) a trend, and/or (ii) a rate of change of blood analyte level; and the one or more operational parameters includes the at least one of the determined (i) trend or (ii) rate of change.
In yet a further variant, the one or more operational parameters includes a proximity to a prescribed boundary or warning criterion associated with determined blood analyte level.
In one implementation, the apparatus includes a small form-factor wearable apparatus, such as a wrist-worn apparatus, pendant, fob, wrist or arm band, etc. In one configuration, the wrist worn apparatus is configured to indicate via the indicator apparatus only a prescribed subset of values, each value of the prescribed subset determined from the received wireless signals only. The prescribed subset of values may include for example: (i) the determined blood analyte level; (ii) a blood analyte level trend indication; and (iii) a blood analyte level rate of change indication.
In another implementation, the wrist-worn apparatus comprising a primary function, and the use with the implanted blood analyte sensing device comprises a secondary function; and the data processing apparatus and the indicator apparatus are configured to execute both the primary function and the secondary function(s). The secondary (e.g., glucose monitoring) function(s) may be enabled through e.g., at least one of a software and/or firmware download to the apparatus after its manufacture. For instance, an NFC- and Bluetooth-enabled smart watch may also have the blood analyte monitoring functions “piggy-backed” onto its normal functions.
In another variant, the apparatus further includes a wireless transceiver apparatus in data communication with the data processing apparatus; the wireless receiver comprises a narrowband radio frequency (RF) receiver; and the wireless transceiver includes a personal area network (PAN) RF transceiver configured to operate within a frequency range which does not overlap with the narrowband RF. In one implementation, the apparatus is further configured to opportunistically establish a communication session with a parent platform via the PAN RF transceiver when such parent platform is at least one of: (i) within sufficient range to establish the communication session; and/or (ii) has sufficient signal strength at the apparatus to establish the communication session. Upon establishment of the communication session, transfer at least one of calibration data and/or configuration data from the parent platform to the apparatus for use by the apparatus until a subsequent opportunistic communication session is established.
In yet another variant, the apparatus comprises a small form-factor wearable apparatus configured to maintain contact with a user's skin, and the indicator apparatus comprises a haptic output apparatus configured to generate haptic output cognizable by the user via the contact, the haptic output configured to encode at least one of: (i) the determined blood analyte level; and/or (ii) one or more alerts or alarms.
In one implementation, the electrical power source comprises a triboelectric generation apparatus. In another implementation, the electrical power source comprises a thermoelectric or Seebeck Effect generation apparatus. In yet another implementation, the electrical power source comprises a solar or photoelectric effect power generation apparatus.
In a further variant, the apparatus further includes a substantially flexible non-conductive substrate with a plurality of electrical traces disposed thereon; and a skin-adherent material configured to enable adherence of the apparatus to a skin of the user such that the substrate at least partly flexes out of a planar geometry as part of the adherence. The indicator apparatus includes a plurality of light-emitting diodes (LEDs) such as OLEDs, configured to generate a numeric indication when illuminated corresponding to the determined blood analyte level. In one implementation, the apparatus is configured to be used for only a prescribed duration, and disposable thereafter.
In still a further variant, the apparatus is configured to be implanted within the user, such as sub-dermally, or within a tooth or other dental structure (e.g., crown, bridge, etc.) of the user. In one implementation, the dental implant includes a transducer configured to generate vibrations that can be transmitted to at least one ear of the user via at least a jawbone of the user. In one configuration, the generated vibrations comprise vibrations forming at least one audible tone within an audible range of a human (20 Hz to 20 KHz nominal), the at least one tone encoding information relating to the determined blood analyte level. In another configuration, the indicator apparatus further includes a speech synthesis apparatus, and the generated vibrations comprise synthesized speech communications within a range of 20 Hz to 20 KHz, the synthesized speech comprising a speech representation of the determined blood analyte level.
In another aspect of the disclosure, a method of operating a blood analyte evaluation system is disclosed. In one embodiment, the system includes an implantable sensor, a local receiver, and a parent platform, and the method includes: utilizing the local receiver to receive and process wireless data transmitted from the implantable sensor on a substantially continuous basis during a first period of time, the local receiver not having data communication with the parent platform during the first period; and only incidentally establishing communication between the local receiver and the parent platform to at least receive calibration data at the local receiver from the parent platform.
In one variant, the incidentally establishing communication between the local receiver and the parent platform includes establishing communication after the first period, and the method further includes utilizing the received calibration data to perform at least one of: (i) confirmation of a current calibration of the implantable sensor; and/or (ii) adjustment to a current calibration of the implantable sensor.
In one implementation, the utilizing the local receiver to receive wireless data transmitted from the implantable sensor includes utilizing a dedicated narrowband wireless receiver to receive the wireless data; and communication between the local receiver and the parent platform includes use of a multiband wireless transceiver apparatus, one or more frequencies of the dedicated narrowband receiver not overlapping with a frequency range utilized by the multiband transceiver apparatus.
In another variant, the only incidental communication between the local receiver and the parent platform to at least receive calibration data at the local receiver from the parent platform further includes receiving user-provided configuration data at the local receiver from the parent platform; and the method further includes utilizing the received configuration data to configure at least one aspect of a user indicator function of the local receiver.
In a further variant, the processing includes determination of a blood glucose level, and the method further includes causing providing to a user within which the implantable sensor is implanted, during the period, one or more representations of the determined blood glucose level.
In yet another aspect of the disclosure, apparatus for use with an implanted blood glucose sensing device is disclosed. In one embodiment, the apparatus is configured to generate an indication cognizable by a user and representative of the user's blood glucose level according to the method comprising: receiving at a power generation device of the apparatus incident first electromagnetic energy; converting the received electromagnetic energy to electrical power; providing the electrical power to at least a processing device of the apparatus and a wireless receiver of the apparatus; receiving at the wireless receiver a plurality of wireless signals generated by the sensing device and encoding data relating to the blood glucose level; processing the received plurality of signals using the processing device to generate an estimate of the blood glucose level; and utilizing an indicator apparatus in communication with the processing device to generate the indication.
In one variant, the apparatus comprises a skin-adherable patch form factor, and the incident first electromagnetic energy comprises solar radiation. In another variant, the incident first electromagnetic energy comprises electromagnetic energy emitted by the implanted sensing device (e.g., the plurality of wireless signals, such as ones emitted predominantly at a prescribed center frequency within a range comprising 400 MHz to 450 MHz inclusive).
In another aspect of the disclosure, a method of monitoring blood glucose level while engaging in a sporting activity is disclosed. In one embodiment, the method includes wearing a limited functionality and limited form-factor local wireless receiver apparatus to: (i) receive data wirelessly transmitted from an implanted blood glucose sensor; (ii) process the received data to generate at least an estimated blood glucose level; and (iii) provide indication of the estimated blood glucose level to the user during the sporting activity. In one variant, the limited form factor is enabled at least in part by the limited functionality (i.e., less functionality equates to smaller form factor), and the limited form factor enhances or enables performance of the sporting activity (e.g., reduces overall wearer weight, hydrodynamic friction, bulk, etc.).
In one implementation, the limited functionality includes indication via an indicator apparatus of the local wireless receiver apparatus of only a prescribed subset of values, each value of the prescribed subset determined from the received wirelessly transmitted data only; e.g., (i) the estimated blood glucose level; (ii) a blood glucose level trend indication; and (iii) a blood glucose level rate of change indication.
In another aspect, a blood glucose monitoring patch for use on a living being is disclosed. In one embodiment, the patch includes: a wireless receiver apparatus; data processor apparatus in signal communication with the wireless receiver apparatus; indicator apparatus in communication with the data processing apparatus; and a power supply configured to supply electrical power to at least the wireless receiver apparatus, the data processor apparatus, and the indicator apparatus. In one variant, the wireless receiver apparatus, data processor apparatus, and indicator apparatus cooperate to (i) enable reception of wirelessly transmitted data from a sensor implanted in the living being, (ii) enable processing of the received data to produce an estimated blood glucose level, and (iii) cause indication of the estimated blood glucose level to the user.
In another variant, the patch is at least partly flexible and is configured to adhere to the skin of the living being for at least a period of time without removal. The power supply comprises a triboelectric generator apparatus that obviates use of a replaceable battery.
In another variant, the patch is configured to be disposable, and the period of time comprises at least one (1) week.
In a further variant, the patch is configured to operate during the period of time, including the production of the estimated blood glucose level and indication thereof, without confirmation or calibration.
Other features and advantages of the present disclosure will immediately be recognized by persons of ordinary skill in the art with reference to the attached drawings and detailed description of exemplary embodiments as given below.
All Figures © Copyright 2016 GlySens Incorporated. All rights reserved.
Reference is now made to the drawings, wherein like numerals refer to like parts throughout.
One aspect of the present disclosure leverages Assignee's recognition that many of the above-described disabilities of the prior art “receiver” approach (including the user being effectively tethered to their analyte monitoring system receiver) can be mitigated or even completely eliminated.
Accordingly, the present disclosure makes use in one exemplary embodiment of a minimal profile (and functionality) receiving device which the user can discretely carry or wear continuously, so as to obviate the bulky and more full-featured receiver(s) of the prior art. In this fashion, the user is largely freed from concerns such as forgetting their receiver/smartphone, having it maintained in a constant state of charge, and notably refraining from activities which would otherwise be impossible or at least highly impractical under the prior art (e.g., watersports including swimming, surfing, scuba and other diving; combat sports including boxing and martial arts; fitness activities or certain competitive sports where a bulky receiver could be damaged or dislodged by vigorous physical activity; performance or other social activities where a bulky receiver would be inappropriate or distracting; or even limited duration space travel).
In one implementation, the aforementioned implantable sensor with oxygen-based detector element(s) is used in conjunction with a small form-factor, limited function wrist device which provides the user with a continuously wearable, all-environment device that outputs necessary user information (including in one variant a digital display of the user's blood glucose level in mg/dL or mmol/L and associated rate/trend indication). Hence, the user experience with the device and quality of life are improved through obviation of the need for contact between the implanted sensor and the user's smartphone or other such receiver (or cloud entity) for at least extended periods of time (e.g., days or even weeks).
In one variant, the aforementioned small form-factor device is battery operated and is configured for ultra-low power consumption, such that the user can wear and utilize the device for extended periods of time without a battery change or charge. Power conservation is accomplished in one configuration through use of one or more of: (i) non-continuous display; (ii) ambient light level sensing (and concurrent adjustment of LED or other display element intensity); and/or (iii) sleep modes for various non-essential components or portions thereof, and ultra-low voltage/low-power integrated circuits (ICs).
In another variant, the small form-factor device utilizes a haptic feedback apparatus either in place of or in conjunction with the aforementioned display so as to discretely inform or alert the user regarding information relating to blood glucose level. For instance, in one configuration, the haptic feedback apparatus is in contact with the user's skin (e.g., on the underside of the aforementioned wrist device) and is used to alert the user as to the need to check their blood glucose level using e.g., the display device, but without the more externally noticeable spontaneous activation of the LED or other display element. In this fashion, the user maintains complete discretion of the information with respect to others around him/her.
Other configurations for the small form-factor device described herein include (without limitation) pendants, jewelry (e.g., rings), dermal patches, portions of garments, wrist or arm bands, hair accessories (e.g., hair bands), eyeglasses, earplugs or other ear-worn accessories, and even implants (e.g., dental or sub-dermal implants) or portions of prosthetics.
Methods of use of the aforementioned membranes and sensor elements are also disclosed herein.
Exemplary embodiments of the present disclosure are now described in detail. While these embodiments are primarily discussed in the context of a fully implantable glucose sensor, such as those exemplary embodiments described herein, and/or those set forth in U.S. Patent Application Publication No. 2013/0197332 filed Jul. 26, 2012 entitled “Tissue Implantable Sensor With Hermetically Sealed Housing;” U.S. Pat. No. 7,894,870 to Lucisano et al. issued Feb. 22, 2011 and entitled “Hermetic Implantable Sensor;” U.S. Patent Application Publication No. 2011/0137142 to Lucisano et al. published Jun. 9, 2011 and entitled “Hermetic Implantable Sensor;” U.S. Pat. No. 8,763,245 to Lucisano et al. issued Jul. 1, 2014 and entitled “Hermetic Feedthrough Assembly for Ceramic Body;” U.S. Patent Application Publication No. 2014/0309510 to Lucisano et al. published Oct. 16, 2014 and entitled “Hermetic Feedthrough Assembly for Ceramic Body;” U.S. Pat. No. 7,248,912 to Gough et al. issued Jul. 24, 2007 and entitled “Tissue Implantable Sensors for Measurement of Blood Solutes;” and U.S. Pat. No. 7,871,456 to Gough et al. issued Jan. 18, 2011 and entitled “Membranes with Controlled Permeability to Polar and Apolar Molecules in Solution and Methods of Making Same;” and U.S. Patent Application Publication No. 2013/0197332 to Lucisano et al. published Aug. 1, 2013 and entitled “Tissue Implantable Sensor with Hermetically Sealed Housing;” PCT Patent Application Publication No. 2013/016573 to Lucisano et al. published Jan. 31, 2013 and entitled “Tissue Implantable Sensor with Hermetically Sealed Housing,” each of the foregoing incorporated herein by reference in its entirety, as well as those of U.S. patent application Ser. Nos. 13/559,475, 14/982,346, 15/170,571, and 15/197,104 previously incorporated herein, it will be recognized by those of ordinary skill that the present disclosure is not so limited. In fact, the various aspects of the disclosure are useful with, inter alia, other types of implantable sensors and/or electronic devices.
Further, while the following embodiments describe specific implementations of e.g., biocompatible oxygen-based multi-sensor element devices for measurement of glucose, having specific configurations, protocols, locations, and orientations for implantation (e.g., proximate the waistline on a human abdomen with the sensor array disposed proximate to fascial tissue; see e.g., U.S. patent application Ser. No. 14/982,346 filed Dec. 29, 2015 and entitled “Implantable Sensor Apparatus and Methods” previously incorporated herein), those of ordinary skill in the related arts will readily appreciate that such descriptions are purely illustrative, and in fact the methods and apparatus described herein can be used consistent with, and without limitation: (i) in living beings other than humans; (ii) other types or configurations of sensors (e.g., other types, enzymes, and/or theories of operation of glucose sensors, sensors other than glucose sensors, such as e.g., sensors for other analytes such as urea, lactate); (iii) other implantation locations and/or techniques (including without limitation transcutaneous or non-implanted devices as applicable); and/or (iv) devices intended to deliver substances to the body (e.g. implanted drug pumps, drug-eluting solid materials, and encapsulated cell-based implants, etc.); and/or other devices (e.g., non-sensors and non-substance delivery devices).
As used herein, the term “analyte” refers without limitation to a substance or chemical species that is of interest in an analytical procedure. In general, the analyte itself cannot be measured, but a measurement of the analyte (e.g., glucose) can be derived through measurement of chemical constituents, components, or reaction byproducts associated with the analyte (e.g., hydrogen peroxide, oxygen, free electrons, etc.).
As used herein, the terms “biocompatible” and “biocompatibility” refer without limitation to the ability of a medical device or implantable material to perform as intended in the presence of an appropriate host wound healing response and/or other immunogenic responses, while minimizing magnitude and duration of the wound healing (e.g., acute inflammation, chronic inflammation, foreign body reaction (FBR), and fibrosis/fibrous capsule development) and causing no significant harm to the patient.
As used herein, the terms “detector” and “sensor” refer without limitation to a device having one or more elements (e.g., detector element, sensor element, sensing elements, etc.) that generate, or can be made to generate, a signal indicative of a measured parameter, such as the concentration of an analyte (e.g., glucose) or its associated chemical constituents and/or byproducts (e.g., hydrogen peroxide, oxygen, free electrons, etc.). Such a device may be based on electrochemical, electrical, optical, mechanical, thermal, or other principles as generally known in the art. Such a device may consist of one or more components, including for example, one, two, three, or four electrodes, and may further incorporate immobilized enzymes or other biological or physical components, such as membranes, to provide or enhance sensitivity or specificity for the analyte.
As used herein, the terms “orient,” “orientation,” and “position” refer, without limitation, to any spatial disposition of a device and/or any of its components relative to another object or being, and in no way connote an absolute frame of reference.
As used herein, the terms “top,” “bottom,” “side,” “up,” “down,” and the like merely connote, without limitation, a relative position or geometry of one component to another, and in no way connote an absolute frame of reference or any required orientation. For example, a “top” portion of a component may actually reside below a “bottom” portion when the component is mounted to another device (e.g., host sensor).
As used herein the term “parent platform” refers without limitation to any device, group of devices, and/or processes with which a client or peer device (including for example the various embodiments of local receiver described here) may logically and/or physically communicate to transfer or exchange data. Examples of parent platforms can include, without limitation, smartphones, tablet computers, laptops, smart watches, personal computers/desktops, servers (local or remote), gateways, dedicated or proprietary analyte receiver devices, medical diagnostic equipment, and even other local receivers acting in a peer-to-peer or dualistic (e.g., master/slave) modality.
As used herein, the term “application” (or “app”) refers generally and without limitation to a unit of executable software that implements a certain functionality or theme. The themes of applications vary broadly across any number of disciplines and functions (such as on-demand content management, e-commerce transactions, brokerage transactions, home entertainment, calculator etc.), and one application may have more than one theme. The unit of executable software generally runs in a predetermined environment; for example, the Java™ environment.
As used herein, the term “computer program” or “software” is meant to include any sequence or human or machine cognizable steps which perform a function. Such program may be rendered in virtually any programming language or environment including, for example, C/C++, Fortran, COBOL, PASCAL, assembly language, markup languages (e.g., HTML, SGML, XML, VoXML), and the like, as well as object-oriented environments such as the Common Object Request Broker Architecture (CORBA), Java™ (including J2ME, Java Beans, etc.) and the like.
As used herein, the terms “Internet” and “internet” are used interchangeably to refer to inter-networks including, without limitation, the Internet. Other common examples include but are not limited to: a network of external servers, “cloud” entities (such as memory or storage not local to a device, storage generally accessible at any time via a network connection, or cloud-based or distributed processing or other services), service nodes, access points, controller devices, client devices, etc.
As used herein, the term “memory” includes any type of integrated circuit or other storage device adapted for storing digital data including, without limitation, ROM, PROM, EEPROM, DRAM, SDRAM, DDR/2 SDRAM, EDO/FPMS, RLDRAM, SRAM, “flash” memory (e.g., NAND/NOR), 3D memory, and PSRAM.
As used herein, the terms “microprocessor” and “processor” or “digital processor” are meant generally to include all types of digital processing devices including, without limitation, digital signal processors (DSPs), reduced instruction set computers (RISC), general-purpose (CISC) processors, microprocessors, gate arrays (e.g., FPGAs), PLDs, reconfigurable computer fabrics (RCFs), array processors, secure microprocessors, and application-specific integrated circuits (ASICs). Such digital processors may be contained on a single unitary integrated circuit (IC) die, or distributed across multiple components.
As used herein, the term “network” refers generally to any type of telecommunications or data network including, without limitation, hybrid fiber coax (HFC) networks, satellite networks, telco networks, and data networks (including MANs, WANs, LANs, WLANs, internets, and intranets), cellular networks, as well as so-called “mesh” networks and “IoTs” (Internet(s) of Things). Such networks or portions thereof may utilize any one or more different topologies (e.g., ring, bus, star, loop, etc.), transmission media (e.g., wired/RF cable, RF wireless, millimeter wave, optical, etc.) and/or communications or networking protocols.
As used herein, the term “interface” refers to any signal or data interface with a component or network including, without limitation, those of the FireWire (e.g., FW400, FW800, etc.), USB (e.g., USB 2.0, 3.0. OTG), Ethernet (e.g., 10/100, 10/100/1000 (Gigabit Ethernet), 10-Gig-E, etc.), MoCA, LTE/LTE-A, Wi-Fi (802.11), WiMAX (802.16), Z-wave, PAN (e.g., 802.15)/Zigbee, Bluetooth, or power line carrier (PLC) families.
As used herein, the term “QAM” refers to modulation schemes used for data or signals. Such modulation scheme might use any constellation level (e.g. QPSK, 16-QAM, 64-QAM, 256-QAM, etc.).
As used herein, the term “server” refers to any computerized component, system or entity regardless of form which is adapted to provide data, files, applications, content, or other services to one or more other devices or entities on a computer network.
As used herein, the term “storage” refers to without limitation computer hard drives, memory, RAID devices or arrays, optical media (e.g., CD-ROMs, Laserdiscs, Blu-Ray, etc.), solid state devices (SSDs), flash drives, cloud-hosted storage, or network attached storage (NAS), or any other devices or media capable of storing data or other information.
As used herein, the term “Wi-Fi” refers to, without limitation and as applicable, any of the variants of IEEE-Std. 802.11 or related standards including 802.11 a/b/g/n/s/v/ac or 802.11-2012/2013, as well as Wi-Fi Direct (including inter alia, the “Wi-Fi Peer-to-Peer (P2P) Specification”, incorporated herein by reference in its entirety).
As used herein, the term “wireless” means any wireless signal, data, communication, or other interface including without limitation Wi-Fi, Bluetooth, 3G (3GPP/3GPP2), HSDPA/HSUPA, TDMA, CDMA (e.g., IS-95A, WCDMA, etc.), FHSS, DSSS, GSM, PAN/802.15, WiMAX (802.16), 802.20, Zigbee®, Z-wave, narrowband/FDMA, OFDM, PCS/DCS, LTE/LTE-A, analog cellular, CDPD, satellite systems, millimeter wave or microwave systems, acoustic, and infrared (i.e., IrDA).
Referring now to
As shown in
The sensor apparatus of
As discussed in greater detail below with respect to
The sensor apparatus 200 also includes in the exemplary embodiment a wireless radio frequency transmitter (or transceiver, depending if signals are intended to be received by the apparatus), not shown. As described in the aforementioned documents incorporated herein, the transmitter/transceiver may be configured to transmit modulated radio frequency signals to an external receiver/transceiver, such as a dedicated receiver device, or alternatively a properly equipped consumer electronic device such as a smartphone or tablet computer. Moreover, the sensor apparatus 200 may be configured to transmit signals to (whether in conjunction with the aforementioned external receiver, or in the alternative) an at least partly implanted or in vivo receiving device, such as an implanted pump or other medication or substance delivery system (e.g., an insulin pump or dispensing apparatus), embedded “logging” device, or other. It is also appreciated that other forms of wireless communication may be used for such applications, including for example inductive (electromagnetic induction) based systems, or even those based on capacitance or electric fields, or even optical (e.g., infrared) systems where a sufficiently clear path of transmission and reception exists, such as two devices in immediately adjacent disposition, or even ultrasonic systems where the two devices are sufficiently close and connected by sound-conductive media such as body tissues or fluids, or a purposely implanted component.
The sensor apparatus of
Moreover, another exemplary embodiment of the sensor apparatus 200 described herein may include either or both of: (i) multiple detector elements with respective “staggered” ranges/rates of detection operating in parallel, and/or (ii) multiple detector elements with respective “staggered” ranges/rates of detection that are selectively switched on/off in response to, e.g., the analyte concentration reaching a prescribed upper or lower threshold, as described in the foregoing patent application Ser. No. 15/170,571.
The present disclosure further contemplates that such thresholds or bounds: (i) can be selected independent of one another; and/or (ii) can be set dynamically while the apparatus 300 is implanted. For example, in one scenario, operational detector elements are continuously or periodically monitored to confirm accuracy, and/or detect any degradation of performance (e.g., due to equipment degradation, progressive FBR affecting that detector element, etc.); when such degradation is detected, affecting say a lower limit of analyte concentration that can be detected, that particular detector element can have its lower threshold adjusted upward, such that handoff to another element capable of more accurately monitoring concentrations in that range.
It will be appreciated that the relatively smaller dimensions of the sensor apparatus (as compared to many conventional implant dimensions)—on the order of 40 mm in length (dimension “a” on
It is also appreciated that some flexibility in component location exists; as such, the present disclosure further contemplates e.g., relocation of certain components within the implanted sensor device 200 such as those associated with signal processing, off-device (i.e., in a receiver module such as the local receiver described subsequently herein, or electronic apparatus external to the implanted sensor, such as a user's smartphone or tablet computer, or other implanted or external medical device) so as to further minimize interior sensor device volume/area requirements. For instance, in one such adaptation, electronic components such as antennas and/or circuit boards (e.g., PCBs) can be wholly or partly replaced with so-called “printable” electronics which reside on, e.g., interior components or surfaces of the sensor device 200 (or for that matter the local receiver 400 and/or output receivers 450, 452 described subsequently herein) such as by using the methods and apparatus described in U.S. Pat. No. 9,325,060 issued Apr. 26, 2016 and entitled “Methods and Apparatus for Conductive Element Deposition and Formation,” which is incorporated herein by reference in its entirety. Other types of space/area-reducing adaptations will be readily recognized by those of ordinary skill in the electronic arts when given the present disclosure.
Referring now to
As indicated in
Specifically, in the illustrated architecture 300, the local receiver 400 acts as a reduced- or limited-functionality indicator and monitor for the user that reliably operates for comparatively extended periods of time without external input or calibration, thereby obviating the parent platform during those periods. As described later herein, the reduced form factor advantageously enables the user to further: (i) engage in activities which they could not otherwise engage in if “tethered” to the parent platform, and (ii) effortlessly keep the local receiver with them at all times, and obtain reliable blood analyte data and other useful information (e.g., trend, rate of change (ROC), and other sensor-data derived parameters), in a non-obtrusive (or even covert) manner.
When the opportunistic communication between the parent platform 600 and the local receiver does occur, the exemplary architecture 300 enables two-way data transfer, including: (i) transfer of stored data extracted from the sensor wireless transmissions to the local receiver, to the parent platform for archiving, analysis, transfer to a network entity, etc.; (ii) transfer of sensor-specific identification data and/or local receiver-specific data between the local receiver and the parent platform; (iii) transfer of external calibration data (e.g., derived from an independent test method such as a fingerstick or blood glucose monitor and input either automatically or manually to the parent platform) from the parent to the local receiver; and (iv) transfer of local receiver configuration or other data (e.g., software/firmware updates, user-prescribed receiver settings for alarms, warning/buffer values, indication formats or parameters, historical blood analyte levels for the user, results of analysis by the parent 600 or network entity 700 of such data, diagnoses, security or data scrambling/encryption codes or keys, etc.) from the parent 600 to the local receiver 400.
Referring now to
As indicated in
When the opportunistic communication between the CSP 650 and the local receiver does occur, the exemplary architecture 310 enables at least one-way data transfer, including transfer of external calibration data (e.g., derived from an independent test method such as the “fingerstick” or other form of blood analyte sensor 655 of the CSP 650 from the CSP to the local receiver 400. In an exemplary implementation, the CSP 650 comprises a “smart” fingerstick apparatus, including at least (i) sufficient onboard processing capability to generate calibration data useful with the local receiver 400 based on signals or data output from the blood sensor 655, and (ii) a data interface to enable transmission of the data to the local receiver 400. In one configuration, the sensor 655 includes a needle or lancet apparatus 657 which draws a sample of the user's blood for the sensor 655 to analyze. Electronic glucose “fingerstick” apparatus (including those with replaceable single-use lancets) and re-usable electronic components are well known in the relevant arts, and accordingly not described further herein. See e.g., U.S. Pat. No. 8,357,107 to Draudt, et al. issued Jan. 22, 2013 and incorporated herein by reference in its entirety, for one example of such technology. The sensor 655 analyzes the extracted blood obtained via the lancet 657 and (via the onboard processing) produces data indicative of a blood glucose level (or at least generates data from which such level may be derived), such data being provided to the communications interface 659 for transfer to the local receiver 400. The transmitted data are then utilized within the local receiver 400 for calibration of the data generated by the implanted sensor 200.
In one variant, the interface 659 comprises a Bluetooth-compliant interface, such that a corresponding Bluetooth interface of the local receiver can “pair” with the CSP 650 to effect transfer of the calibration data wirelessly. Hence, the user with implanted sensor 200 can simply use a fingerstick-based or other type of external calibration data source to periodically (e.g., once weekly) confirm the accuracy and/or update the calibration of the implanted sensor 200 via opportunistic communication between the local receiver 400 (e.g., small profile wristband, fob, etc.) when convenient for the user. Advantageously, many persons with diabetes possess such electronic fingerstick-based devices, and wireless communication capability is readily added thereto by the manufacturer at little additional cost.
In another variant, the communications interface comprises an IR or optical “LOS” interface such as one compliant with IrDA technology, such that the user need merely establish a line-of-sight path between the emitter of the CSP 650 and the receptor of the local receiver 400, akin to a television remote control. As yet another alternative, a near-field communication (NFC) antenna may be utilized to transfer data wirelessly between the apparatus 400, 650 when placed in close range (i.e., “swiped”). Yet other communication modalities will be recognized by those of ordinary skill given the present disclosure.
Referring now to
In one implementation, the sensor apparatus 200 is configured to store the generated blood glucose levels as well as the periodically received calibration data within onboard data storage, for later transfer to the local receiver 400. The calibration data can also be used by the sensor apparatus 200 before such transfer to calibrate, or confirm the accuracy of, the (internally) generated measurements of blood glucose, such that only calibrated/confirmed measurement data are stored (without having to also store or subsequently transfer the calibration data itself).
It will be appreciated that the architectures shown in
Referring now to
As shown, the local receiver apparatus 400 includes a processor 404 (e.g., digital RISC, CISC, and/or DSP device), and/or a microcontroller (not shown), memory 406, software/firmware 408 operative to execute on the processor 404 and stored in e.g., a program memory portion of the processor 404 (not shown), or the memory 406, a mass storage device 420 (e.g., NAND or NOR flash, SSD, etc. to store received raw or preprocessed data, post-processed data, or other data of interest), a wireless interface 416 (e.g., narrowband or other, described below) for communication with the sensor apparatus 200, a communications (e.g., wireless) interface 414 for communication with the parent platform 600, and a power supply 430 (e.g., NiMH or Lithium ion battery, or other as described below). The apparatus 400 also includes one or more output device(s) 410 for communication of the desired data (e.g., glucose level, rate, trend, battery “low” alerts, etc.). As described in greater detail subsequently herein the output device(s) may include for example visual, audible, and/or tactile (e.g., haptic) modalities, which can be used alone or in concert depending on desired functionality and local receiver configuration.
As can be appreciated by those of ordinary skill given the present disclosure, any number of different hardware/software/firmware architectures and component arrangements can be utilized for the local receiver apparatus 400 of
In one exemplary implementation, the protocol used to communicate between the in vivo device(s) (e.g., the sensor device 200 of
In another variant, the output receiver 450 is configured with a haptic or vibrational mode whereby data useful to the user can be encoded and communicated to the user directly through the user's anatomy. For instance, haptic “codes” of the type described subsequently herein with respect to
In another configuration, the aforementioned “kiosk” or station functionality is integrated within the infotainment system of the user's car (not shown), such that the user can simply get in their car and cause readout of their blood analyte levels through e.g., an installed RF interrogator apparatus within the dashboard or other structure of the car. Moreover, it will be appreciated that the car infotainment system can in effect act like the local receiver 400 of
In that the exemplary receiver 450 is passively powered, it arguably never needs explant unless it fails. Moreover, its form factor can much smaller than that of even the sensor apparatus, and can (and generally should) be implanted very superficially, such that the host experiences extremely little tissue trauma during the procedure.
It is appreciated that the receiver 450 of the embodiment of
Moreover, the implanted local receiver 400 can be configured such that the power supply 430 is passively activated (e.g., through incident RF energy, including that of the sensor 200, as described elsewhere herein), thereby obviating explants of the device (except for component failure).
The receiver apparatus 400 of
In the exemplary embodiment, a biocompatible and moisture-resistant adhesive (not shown) is also deposited onto the back surface of the substrate element 413, so as to permit temporary bonding of the patch apparatus 400 to the user's skin. Such adhesives are well known in the medical arts (suitable adhesives used for bandages, skin-attached appliances and the like), and accordingly are not described further herein.
Advantageously, the location of adhesion of the patch apparatus 400 is not significant for utilization of the apparatus; the user can place it literally anywhere it can adhere to (including under clothing, etc.) so as to be completely discrete.
In one implementation, the display device 410 comprises a substantially flat and flexible LED (e.g., graphene-based), AMOLED, or OTFT (organic thin-film transistor) display device which is configured to display desired information such as analyte concentration in the wearer's blood based on received signals transmitted from the implanted sensor and received via the sensor interface 416. Such OLED and OTFT-based elements are advantageously highly power efficient, and hence both conserve energy (thereby extending the lifetime of any static power supply used, such as a battery), and enable use of “dynamic” power supplies such as those described below which generally produce limited amounts of electrical power.
The patch apparatus 400 may be powered in one approach by a miniature, low-profile battery (e.g., Lithium-based device of the type well known in the art) with sufficient mAh capacity for the intended use lifetime (for instance, in the case of a disposable patch, the intended lifetime may be a few days or one week, and the battery is sized accordingly for that period).
In another exemplary configuration, the patch is powered by a flexible triboelectric or “static electricity”-based generator. See, e.g., Dhakar, Lokesh, et al, “Skin based flexible triboelectric nanogenerators with motion sensing capability”, 2015 28th IEEE International Conference on Micro Electro Mechanical Systems (MEMS) Jan. 18, 2015 (ISBN 978-1-4799-7955-4), incorporated herein by reference in its entirety, for one exemplary configuration of such tribolelectric generator apparatus useful with the present disclosure, although it will be appreciated that other types of device may be substituted. The aforementioned triboelectric nanogenerator (TENG) of Dhakar, et al uses an outermost layer of human skin (i.e., epidermis) as an active triboelectric layer for device operation, and generates an open circuit voltage of ˜90V with mild finger touch. The device uses PDMS nanopillar structures for the charging of two surfaces, and has been demonstrated as a wearable self-powered device which can be used as a motion and activity sensor as well as a power supply for electronic components such as those of the apparatus 400 of
In yet another variant, the patch apparatus 400 includes a passively powered (i.e., by incident electromagnetic energy) energy supply 430 which utilizes received RF energy from the sensor implant transmitter 200 (or another source, such as an external interrogator device) to power the components necessary to demodulate the incoming RF signal, unscramble it, extract the data from the demodulated and unscrambled signal, process the extracted data, and cause illumination of one or more light sources (e.g., ultra-low power LEDs) on the patch indicating the estimated analyte level. See, e.g., Takei, Ken et al; “Design for a 400-MHz Passive RFID Prototype System for Long Range Applications” Proceedings of ISAP2007, Niigata, Japan, January 2007, incorporated herein by reference in its entirety, which describes a passive radio frequency identification (RFID) system operating at 400 MHz using one or more of a distributed current antenna operating in a balanced circular polarized mode, a full wave rectifier fabricated from the balanced circuit independent from the RFID chip, and a feed forward circuit implanted with a carrier leak cancellation circuit (including a switch modulator, matching circuit, rectifier, and microprocessor) for, inter alia, extracting electrical power from the incident 400 MHz signal. See also “Wearable Flexible Lightweight Modular RFID Tag With Integrated Energy Harvester;” IEEE Transactions on Microwave Theory and Techniques, June 2016 (DOI: 10.1109/TMTT.2016.2573274), also incorporated herein by reference in its entirety, for alternative configurations. In this fashion, the “passive” patch apparatus 400 can extract electrical power to operate the display, processor, etc. from RF energy incident upon it, without need for a battery or other power source. In one such implementation, the antenna and matching circuitry of the patch power supply 430 (as contrasted to that associated with either the primary wireless receiver 416 or the secondary PAN transceiver 414) can be tuned to the frequency emitted by the sensor 200, such as 433 MHz, and make coincident use of the RF signal for energy. In another implementation, the primary wireless receiver 416 can be configured to perform both passive energy “harvesting” from the incident signal, as well as the aforementioned receipt and demodulation of the transmitted sensor data for ultimate unscrambling and extraction thereof (see
It will also be appreciated that the implanted sensor 200 may also be configured with a rechargeable battery or storage cell and associated circuitry of the type known in the art, such that the battery or cell can be recharged in vivo, such as via an inductive charging approach, via energy harvested via movement of the host during their normal activities, or even via incident RF energy. In this fashion, any energy expended by the implanted device 200 to power the external patch apparatus 400 (or for other purposes, such as communication with other devices) can be offset through periodic recharging of the battery or cell.
In yet another variant, a photoelectric device (e.g., solar cell or array) can be used as the power supply 430 to the patch, whether alone or in combination with other supplies. It is appreciated that sufficient ambient light is needed to support operation of the patch 400 under purely solar power, which may not always be available (or, for instance, the patch 400 may be applied under the user's clothing for discretion). Hence, use of the foregoing solar cell(s) along with either (i) an energy storage device, or (ii) another, not-light dependent power supply is desirable in terms of user flexibility and reliability of the apparatus 400 for providing the desired monitoring and indication functions.
Moreover, regardless of power supply 430 configuration (i.e., triboelectric, battery, passive RF, motion-based, or solar), exemplary implementations of the patch apparatus 400 also include logic (e.g., rendered within the code executed on the processor 404, or even in hardware) which maintains various components of the apparatus (including the display and circuitry of the wireless interface 416) in a dormant state except when needed; i.e., when the user desires to observe the display, and/or when the wireless receiver of the patch must be powered on to receive modulated RF signals from the implanted sensor 200. For instance, in one variant, a portion of the pipeline of the processor apparatus 404 is shut down along with relevant portions of the display 410 and wireless interface 416, until a user-instigated event occurs (e.g., the user touches the patch, thereby generating a capacitive input) which wakes the dormant portion of the processor 404, which then executes instructions to wake the wireless interface 414, process the received wireless signals (i.e., demodulate and unscramble as described subsequently herein with respect to
In one implementation of the foregoing “patch” variants, the patches 400 are sold as a disposable commodity; e.g., a pack of twenty (20) which can be individually utilized by the user when a predecessor patch requires replacement due to loss, damage, or merely normal wear and tear. The patches can advantageously be manufactured as a low cost commodity (i.e., Bluetooth interface ICs, digital processors, memory, flexible PCBs, and other such components are currently highly commoditized and fungible in nature, and can be procured extremely inexpensively), and be designed for only a limited use lifetime, similar to prior art contact lens or other disposable biomedical products.
The patches can, as with other embodiments disclosed herein, also be made “self initializing” such that when initially activated, they handshake with the implanted sensor device 200 to ascertain the necessary scrambling code and other relevant data, such as transmission schedule for synchronization. In this manner, the user can merely enable a new (replacement) patch, and once synchronized with the sensor device 200, merely apply it to their skin in the desired location, and begin periodic monitoring using the new patch.
As yet other alternatives, the local receiver apparatus 400 may take the form of a badge or patch that can be temporarily or semi-permanently affixed to the user's clothing, hair accessory, eyeglass/sunglass frame, or yet other personal accessory.
In one implementation, a patch generally similar to that described supra with respect to
Alternatively (or additionally), the haptic apparatus may simply encode a fuzzy logic or similar variable (e.g., one “buzz” or impulse for low, two in close sequence for moderate, three in sequence for high, and continuous for “acute/emergency” blood glucose levels). Other encoding schemes can be used for alerts as well, such as modulation of the intensity of the impulses (e.g., small impulse amplitude for a non-severe alert, higher amplitude for a greater urgency, etc.).
The foregoing encoding schemes (and yet others) can also be used in other form factors of local receiver 400 described herein if desired, such as the pendant/fob of
The applied “patch” or stick-on can also utilize display devices/formats similar to those of the apparatus 400 of FIG. N if desired, such as where the user adheres the device to say an existing prosthetic, piece of jewelry, etc. that is constantly carried on or with them, and which is readily visible to the user.
In another implementation, the blood analyte display/haptic functionality is incorporated into an extant electronic device, such as via a software/firmware upgrade and inclusion of an appropriate wireless interface and processing logic. For instance, in one such implementation, a smart watch with onboard processor, memory, display, WLAN interface (e.g., Wi-Fi), PAN wireless communication interface (e.g., Bluetooth or Zigbee compliant) and NFC (near field communication) interface can be used as the basis of the local receiver functionality. Specifically, in one approach, an “app” is downloaded onto the smart watch which is accessible by the user; the app controls operation of the Bluetooth or WLAN (receiver to parent) interface for opportunistic communications, as well as the NFC interface for communication with the sensor device. In the case of an implanted sensor device such as the device 200 of
In a further variant, the apparatus comprises an “ear bud” or ear plug (or set thereof) which communicates with the user via audible output (and the implanted senor and parent platform via its wireless interfaces 416, 414 respectively). In one implementation, the ear bud or plug is configured for wireless data communication with the implanted sensor and is battery powered, and the audible output comprises a synthesized voice readout of the numerical value of blood glucose level or other information of interest (see discussion of speech synthesis technology infra). In another implementation, the audible output comprises a series of discrete tones which encode the numeric value, and/or which are indicative of one or more alerts or action items for the host, similar to the haptic encoding scheme described supra.
Likewise, the foregoing functionality can be combined within or added to an extant hearing aid if present.
In yet a further variant, the apparatus comprises a ring or band worn on a user's finger, and which communicates with the user via haptic output (and the implanted senor and parent platform via its wireless interfaces 416, 414 respectively). In one implementation, the ring is configured for wireless data communication with the implanted sensor 200 and is battery powered, and the haptic output (e.g., a small haptic oscillator embedded on the interior surface of the band contacting the user's skin) encodes the numerical value of blood glucose level or other information of interest (see discussion of haptic encoding schemes elsewhere herein). In one variant, the ring comprises a wedding band, which the user ostensibly wears at all times and hence is unlikely to be forgotten or lost due to its sentimental value. Other ring form factors are contemplated as well, such as engagement rings. university or alumni rings, etc., all which have a larger profile than the aforementioned wedding band (and hence more interior volume for components including a larger battery).
It is also appreciated that various of the devices 400 described herein can include a recharge capability; e.g., inductive charging by placing the device in proximity to a charging “plate” or other structure for a period of time, thereby enabling the magnetic inductance of the charger to induce electrical currents within the receiver charging circuit (not shown) to charge a rechargeable (e.g., Lithium-based) storage cell. While somewhat less desirable from the standpoint that the user must in effect monitor power level (as compared to a primary battery, which can last months or even years), such recharging capability can be used to achieve other desirable functions, such as an emergency “backup” capability (i.e., if the battery dies unexpectedly and no replacement is immediately available). An exemplary wireless charging circuit and device is described in U.S. Pat. No. 9,362,776 issued Jun. 7, 2016 and entitled “Wireless charging systems and methods”, incorporated herein by reference in its entirety, although other approaches may be used with equal success.
It is also appreciated that various of the embodiments of the receiver apparatus described herein may utilize (whether alone or in conjunction with other power sources) a thermo-electric power generation apparatus (not shown), for example one utilizing the Seebeck effect. As is well known, a thermoelectric device can be made using a thermocouple with two conducting paths with two different conductive materials (e.g., different metal alloys such as chrome and iron) or different semiconductors or a combination of a semiconductor and a metal alloy (e.g. p-doped silicon and copper). Between two open contact points a voltage VAB, also referred to as the Seebeck voltage, is generated in the presence of a temperature gradient between the first and second end of the thermocouple. Such voltage can be used to, inter alia, power electrical devices (including the ICs and other components 404, 406, 410 of the local receiver), charge a storage cell, etc. See, e.g., U.S. Pat. No. 9,444,027 issued Sep. 13, 2016 and entitled “Thermoelectrical device and method for manufacturing same”, incorporated herein by reference in its entirety, for one exemplary configuration of, and method of manufacturing, a thermoelectric device useful with the present disclosure. The present disclosure appreciates that such local receiver apparatus, when in contact with various portions of the human body, may experience such a temperature gradient (e.g., due to ambient temperature differential, natural thermal gradients in the body, etc.), such that a Seebeck-based generator can be utilized, thereby further economizing on weight, space, and in some cases obviating any sizable energy storage device such as a battery.
In yet a further variant, the local receiver 400 of the architecture 300 of
As can be appreciated, certain dental structures such as porcelain crowns, etc. have extremely limited space, and hence practical limitations on radio frequency interface selection are imposed due primarily to antenna dimension requirements. Hence, while not limited as such, the present disclosure primarily contemplates use of frequencies in the hundreds of MHz to GHz ranges (e.g., 400 MHz through 6 GHz) for both the wireless sensor interface 416 and the parent (e.g., PAN) wireless interface 414. Notably, many extant short range wireless communications standards such as Zigbee, Bluetooth, and RFID operate within such bands (whether licensed or unlicensed; e.g., 900 MHz, 2.4 GHz, 5.8 GHz), and hence are potential candidates for the wireless communications interfaces 414, 416, the primary or sensor interface 416 of the apparatus also limited by propagation of radio frequency energy (at a prescribed radiated power level) through the host's tissue when utilizing an implanted sensor such as the apparatus 200 of
In one implementation of the apparatus of
In another implementation, the processor 404 of the dental implant 400 of
In operation, the implant apparatus 400 of
Referring now to
As shown in the Figure, the method 500 begins with the user or clinician enabling the sensor (e.g., implanted device 200 of
Next, the local receiver apparatus 400 (e.g., any of those of
Per step 506, the enabled sensor 200 communicates data wirelessly to the local receiver 400, such as on a periodic, event-driven, or other basis. Note that the transmission and reception frequencies or schedule need not necessarily coincide completely. For instance, the transmitter of the sensor apparatus 200 may transmit according to a prescribed periodicity or frequency, while the local receiver 400 may utilize a less frequent sampling of the transmissions.
In one such implementation, the wireless signals are transmitted from the sensor device e.g., only at prescribed times or prescribed intervals, and the apparatus is configured to synchronize the schedule, and enable the components of the wireless receiver apparatus to receive the wireless signals only during the prescribed times or at the prescribed intervals, and otherwise maintain at least a portion of the wireless receiver apparatus in a dormant or sleep state so as to conserve electrical power. For example, the processor 404 may only “wake up” the receiver 416 and other components for reception of the prescribed events, and then return them to a sleep state thereafter.
In a further variant, the wireless signals are transmitted from the sensor device 200 only at prescribed times, and the wireless receiver apparatus is configured to receive the wireless signals during a number n of prescribed times, the number n being less than a total number of transmissions of wireless signals. The local receiver logic can further be configured to dynamically vary the number n based at least on one or more operational parameters, such as e.g., a remaining level of power in the electrical power source (e.g., battery level, as determined by a known voltage versus capacity profile), a time period from when a last prior calibration was applied to the data relating to levels of the blood analyte (e.g., when was the last calibration data input received from the parent platform), the determined blood analyte level (i.e., sampling may vary and become more frequent as the detected blood glucose level approaches an alert or boundary level), and/or detection of an ambulatory or non-ambulatory state of the user (e.g., the sampling frequency can be reduced when the user is asleep, or otherwise in a state where the rate of change of blood glucose level is expected to be substantially stable).
Per step 508 of the method 500, the received sensor data are processed to calculate blood analyte level, and any related parameters or data derived therefrom. Such processing may occur when the data are received, or collectively in one or more aggregations or batches of data (e.g., sensor data collected or received over a prescribed time period).
Per step 510, the calculated blood analyte level (e.g., glucose concentration in e.g., mg/dL or mmol/L) is output to the user in a cognizable form, such as visually, via haptic apparatus, audibly, and/or yet other means, as described elsewhere herein. Similarly, other information (such as trend of the blood glucose level, rate of change, and/or alerts) may be output from the local receiver 400 via the same or different cognizable medium. For instance, in one embodiment, the blood glucose level is displayed on a display device of the local receiver as a sequence of numbers (e.g., “123”), while alerts or warnings are output as audible tones or “chirps,” and/or haptic pulses to the user via the local receiver's contact with their skin. Numerous permutations of the foregoing will be appreciated by those of ordinary skill given the present disclosure.
Per step 512, the method 500 further determines whether the parent platform 600 (e.g., the user's more fully-functioned tablet, smartphone, etc.) is “communicative” with the local receiver 400. This determination may be made actively or passively, periodically or based on an event, and directly or indirectly. Specifically, the method step 512 contemplates various different approaches to determination of whether communications can (or should) be established with the parent platform 600, including without limitation: (i) evaluating a signal strength (such as a Bluetooth RSSI or other metric) of a beacon or other signal transmitted by a wireless interface of the parent platform; (ii) issuing a probe or other communication signal or request, and evaluating any response thereto (or lack thereof); (iii) receiving one or more communications (e.g., messages) from an application layer process of the parent platform, indicating e.g., either current availability/readiness for data communication (one-way or two-way), a “back-off” period after which the local receiver can/should attempt communication again, or other information relating to one- or two-way data transfer between the local receiver and parent platform (such as the presence of a software/firmware update for the local receiver). The foregoing step of the exemplary embodiment is considered “opportunistic” in the sense that such communication between the local receiver and the parent platform is required only very infrequently (e.g., once a week, or even less frequently), owing in large part to the excellent stability and reliability of the exemplary implanted blood analyte sensor 200 over time. This underscores one salient advantage of the architecture of the present disclosure; i.e., the ability of the user to divorce themselves (and the local receiver) from the parent platform for extended periods of time, and in effect only enable communication between the parent and local receiver when convenient (e.g., once a week, or less).
Returning to
To that end, the present disclosure also contemplates varying types of local receiver apparatus 400; e.g., for different age groups, with features and functionality particularly adapted for that age group. For instance, a “senior” device might include larger numerals for easy readability, alerts with mandatory acknowledgements to confirm that an action was taken (e.g., ingestion of a certain food or medication), etc. Similarly, a “juvenile” version might include the aforementioned parental control functions, be limited in terms of settings or other features that can be altered by the juvenile, a GPS-based “child locator” function, etc.
Hence, one implementation of the method (and underlying system architecture) contemplates “parental controls” of sorts, such that the parent platform of the controlling user (e.g., mother) is configured to control one or more functions of the controlled party's (e.g., child's) local receiver and its interaction with the parent platform (e.g., mother's smartphone and installed application layer software), so that (i) any significant events such as blood glucose transients are not missed and are properly “alarmed,” and (ii) proper calibration is conducted (if needed), the foregoing controlled from the parent platform application software user interface (UI) which recognizes both local receivers, and maintains configuration and calibration data for both.
Per step 522 of the method 500, the local receiver(s) receive the configuration and/or calibration data as applicable from the parent platform, and per step 524, utilize the received data to confirm calibration of the sensor e.g., through comparison of “fingerstick” or blood glucose monitor (BGM) values entered by the user via the parent platform software UI. In one implementation, when calibration is required (e.g., the received or external calibration data varies from the corresponding value calculated by the local receiver based on the sensor data more than a prescribed amount), the user is presented with a “OK to update calibration?” or similar message or indication, requiring the user to affirmatively confirm insertion of the calibration data. In other implementations, such updates can be: (i) automatically inserted; (ii) inserted after a sufficient number of independent external data points (and sensor-based calculated values) are available for averaging or other statistical or algorithmic analysis; or (iii) inserted only to a permissible level of change (e.g., not to exceed 5% variation from the extant sensor-based value). Myriad other permutations or variations on the foregoing will be appreciated by those of skill in the art given the present disclosure.
Per step 526, the configuration of the local receiver (e.g., the alarm setting values, alert logic or hierarchy such as “haptic then visual then audible”, etc.) is also updated as needed.
Alternatively, if the parent platform is not “communicative” (e.g., outside range, busy, preempted, etc.) per step 512 of the method, the calibration status of the local receiver 400 is determined by, for instance, the onboard logic of the local receiver per step 514. For example, in one implementation, the status check of step 514 comprises determining the relationship of a time since last calibration/update to a prescribed value stored in memory as part of the initial configuration of the device (e.g., N days). So, if the local receiver 400 has for instance not received any external calibration data for six (6) days, and the user has pre-configured the “alert” level for calibration to be six days, the local receiver will generate a visual, haptic, and/or audible alert for the user per step 516, in effect alerting the user for the need to pair the local receiver to the parent platform (or otherwise confirm the accuracy of the calculated value, such as via fingerstick test and direct comparison by the user). If the preconfigured threshold or alert level has not been exceeded, the method 500 returns to step 506, where periodic receipt and processing of sensor data is continued.
In the exemplary implementation, regardless of spectral access technique, scrambled sensor data are modulated onto the carrier(s) by the transmitter of the sensor apparatus 200 to encode “raw” sensor data, for use by the local receiver at step 532. The data are scrambled before modulation onto the carrier(s) by a scrambling algorithm operative to run on the sensor apparatus 200 in order to maintain some degree of user/data privacy and avoid surreptitious interception and use, although it will be appreciated that other approaches may be used (e.g., the data may be unscrambled but encrypted according to an AES/DES algorithm or public/private key pair scheme, cryptographically hashed using a one-way hash algorithm, etc.). In one implementation, the scrambling is conducted according to a prescribed sequence; i.e., based on data unique to the particular local receiver (e.g., MAC-64 or EUI 64 MAC address). The local receiver 400 knows only its own unique data, and hence can only unscramble wireless transmissions from its own “host” sensor, thereby avoiding situations where one user's local receiver receives and unscrambles the data transmitted from another user's implanted sensor 200.
In another variant, the scrambling is conducted based on a concatenation or combination of (i) the unique data of the local receiver 400, and (ii) unique data of the sensor 200, such that the local receiver 400 must know both sets of unique data before it can unscramble the received signals (such as data exchange via an initial “pairing” or handshake of the user's particular local receiver and their implanted device, e.g., at time of purchase of the local receiver or implantation of the sensor 200).
Next, per step 534, the received modulated and scrambled signals are demodulated at the local receiver to extract the scrambled data signal. For example, the signals may have been modulated onto the carrier(s) by the transmitter using any number of different schemes, such as FSK, QPSK, DPSK, ASK, GMSK, QAM, etc., and accordingly are demodulated by the receiver according to the same scheme.
The demodulated and scrambled signals are then unscrambled per step 536 (as described above), such as using a device-specific or unique scrambling code. After unscrambling, the “raw” transmitted sensor data packet is then timestamped per step 538 so as to preserve its temporal information (including ordering of the data), and stored within the local receiver's memory device (e.g., flash memory) for subsequent use per step 521 of
It will be recognized that while certain embodiments of the present disclosure are described in terms of a specific sequence of steps of a method, these descriptions are only illustrative of the broader methods described herein, and may be modified as required by the particular application. Certain steps may be rendered unnecessary or optional under certain circumstances. Additionally, certain steps or functionality may be added to the disclosed embodiments, or the order of performance of two or more steps permuted. All such variations are considered to be encompassed within the disclosure and claimed herein.
While the above detailed description has shown, described, and pointed out novel features as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the device or process illustrated may be made by those skilled in the art without departing from principles described herein. The foregoing description is of the best mode presently contemplated. This description is in no way meant to be limiting, but rather should be taken as illustrative of the general principles described herein. The scope of the disclosure should be determined with reference to the claims.
This application is related to co-owned and co-pending U.S. patent application Ser. No. 13/559,475 filed Jul. 26, 2012 entitled “Tissue Implantable Sensor With Hermetically Sealed Housing,” Ser. No. 14/982,346 filed Dec. 29, 2015 and entitled “Implantable Sensor Apparatus and Methods”, Ser. No. 15/170,571 filed Jun. 1, 2016 and entitled “Biocompatible Implantable Sensor Apparatus And Methods”, Ser. No. 15/197,104 filed Jun. 29, 2016 and entitled “Bio-adaptable Implantable Sensor Apparatus And Methods”, and Ser. No. 15/359,406 filed Nov. 22, 2016 and entitled “Heterogeneous Analyte Sensor Apparatus and Methods”, each of the foregoing incorporated herein by reference in its entirety. This application is also related to U.S. patent application Ser. No. 10/719,541 filed Nov. 20, 2003, now issued as U.S. Pat. No. 7,336,984 and entitled “Membrane and Electrode Structure for Implantable Sensor,” also incorporated herein by reference in its entirety.
