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Title:
A DEVICE, SYSTEM, METHOD, AND/OR COMPUTER READABLE MEDIUM FOR USE WITH BIOLOGICAL AND NONBIOLOGICAL DATA
Document Type and Number:
WIPO Patent Application WO/2016/026028
Kind Code:
A1
Abstract:
Disclosed is a device, system, method and computer readable medium for use with biological and nonbiological data to determine indicators and/or identify trends on an individual or population scale. A reconciled combination of one or more sets of data associated with a user is compared with reference or population data to generate a report, indicator or status of the user. Also disclosed is a flexible adhesive surface comprising a topographical pattern for removeably adhering a body to a surface. A method for preparing an adhesive elastomer and for incorporating electronic components into elastomers is further disclosed.

Inventors:
NICKERSON, Ken (208 Beacon Hall Drive, Aurora, Ontario L4G 0L3, CA)
MOUCHANTAF, Anthony (4 Devonshire Place, Toronto, Ontario M5S 2E1, CA)
MONTGOMERY, Miles James (37 Grosvenor Street, apt. 1001Toronto, Ontario M5S 3K6, CA)
MOSA, Alexander Ibrahim (26 St. Joseph Street, apt. 502Toronto, Ontario M4Y 1K1, CA)
BROOKS, Robert Joseph (20 Carlton Street, Suite 225Toronto, Ontario M5B 2H5, CA)
EDDINE, Firas Kamal (21 Carlton Street, Unit 802Toronto, Ontario M5B 1L3, CA)
BORAH, Aniruddha (21 Carlton Street, Unit 802Toronto, Ontario M5B 1L3, CA)
ZHANG, Wenzhong (38 Dan Leckie Way, Unit 808Toronto, Ontario M5V 2V6, CA)
ROBERTSON, Sean (1001 Bay Street, 2314Toronto, Ontario M5S 3A6, CA)
SLATER, Benjamin (104 Baldwin, Toronto, Ontario M5T 1L6, CA)
Application Number:
CA2015/000477
Publication Date:
February 25, 2016
Filing Date:
August 26, 2015
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
DIMARIS CORPORATION (4 Devonshire Place, Toronto, Ontario M5S 2E1, CA)
International Classes:
C09J101/00; A61B5/00; C09J7/02; G06F19/00; G06F19/28; A61L15/30; B32B37/12
Foreign References:
US7616110B22009-11-10
US8467860B22013-06-18
US7899535B22011-03-01
US6221011B12001-04-24
Attorney, Agent or Firm:
FASKEN MARTINEAU DUMOULIN LLP (333 Bay Street, Suite 2400Bay Adelaide Centre, Box 2, Toronto Ontario M5H 2T6, CA)
Download PDF:
Claims:
THE EMBODIMENTS FOR WHICH AN EXCLUSIVE PRIVILEGE OR PROPERTY IS CLAIMED ARE AS FOLLOWS:

1. A system for determining a wellness indicator associated with a user, wherein the system comprises:

(a) a device, associated with the user, comprising: (i) a sensor adapted to receive a set of data associated with the user; and (ii) a device processor operative to collect and transmit the set of data associated with the user;

(b) a parent processor operative to: (i) electronically receive the set of data associated with the user from the device processor; (ii) combine and/or reconcile the set of data associated with the user to generate user data; and (iii) compare the user data with population data, corresponding to the set of data, to determine the wellness indicator associated with the user; and

(c) a parent database to electronically store the user data and the wellness indicator; wherein the system is operative to facilitate the determination of the wellness indicator associated with the user.

2. A system for determining a wellness indicator associated with a user, wherein the system comprises:

(a) a device, associated with the user, comprising: (i) a first sensor adapted to receive a first set of data associated with the user; (ii) a second sensor adapted to receive a second set of data associated with the user; and (iii) a device processor operative to collect and transmit the first and second sets of data associated with the user;

(b) a parent processor operative to: (i) electronically receive the first and second sets of data associated with the user from the device processor; (ii) combine and/or reconcile the first and second sets of data associated with the user to generate user data; and (iii) compare the user data with population data, corresponding to the first and second sets of data, to determine the wellness indicator associated with the user; and

(c) a parent database to electronically store the user data and the wellness indicator; wherein the system is operative to facilitate the determination of the wellness indicator associated with the user.

3. The system of any one of claims 1 and 2 wherein the data associated with the user comprises: heart rate, heart rate variability, breathing rate, stress, anxiety, sleep, focus, cognition function, cardiac health, stress loads on structures, location, movement, posture, infection status, immune status, activity, temperature, respiration, activity, muscle information, neurologic information, serologic information, and/or epigenetic information.

4. A device for use in determining a wellness indicator associated with a user, wherein the device comprises:

(a) a sensor operative to receive a set of data associated with the user;

(b) a device processor operative to collect the set of data associated with the user from the sensor and electronically transmit the set of data associated with the user to a parent processor to: (i) combine and/or reconcile the set of data associated with the user to generate user data; and (ii) compare the user data with population data, corresponding to the set of data, to determine the wellness indicator associated with the user.

5. A method for use with data associated with a user, and for use with a determination of a wellness indicator associated with the user, wherein the method comprises the steps of:

(a) operating a sensor to receive a set of data associated with the user;

(b) operating a device processor to collect the set of data associated with the user from the sensor and transmit the set of data associated with the user;

(c) operating a parent processor to electronically receive the first set of data associated with the user from the device processor to: (i) combine and/or reconcile the set of data associated with the user to generate user data; and (ii) compare the user data with population data, corresponding to the set of data, to determine the wellness indicator associated with the user; and

(d) electronically storing the user data and the wellness indicator in a parent database; wherein the user data and the reconciled set of data thereof are for use in determining the wellness indicator.

6. A computer readable medium on which is physically stored executable instructions for use in association with data associated with a user; for use with determining a wellness indicator associated with the user; wherein the executable instructions comprise processor instructions for a device processors of a device and/or a parent processor to automatically:

(a) collect and/or electronically communicate a set of data associated with the user from the device processor to the parent processor;

(b) combine and/or reconcile the set of data associated with the user to generate user data;

(c) compare the user data with population data, corresponding to the set of data, to determine the wellness indicator associated with the user; and

(d) electronically store the user data and the wellness indicator in a parent database; wherein the user data and the reconciled set of data thereof are for use in determining the wellness indicator.

7. A device for adhering to a surface having a surface shape comprising:

(a) a body adapted to conform to the surface shape;

(b) one or more components embedded in the body; and (c) an adhesive surface, integral with the body, comprising a topographical pattern and adapted to removeably adhere the device to the surface.

8. The device of Claim 7 wherein the body comprises a rigid printed circuit board.

9. The device of Claim 7 wherein the body comprises a flexible printed circuit board.

10. The device of Claims 8 and 9 wherein the body comprises conducting particles.

1 1. The device of any one of Claims 7 to 1 1 wherein the body is an elastomer, foam or plastic.

12. The device of any one of Claims 7 to 1 1, wherein the topographical pattern covers at least a portion of the adhesive surface.

13. The device of Claim 12, wherein the topographical comprises a singular contiguous microstructure and/or macrostructure.

14. The device of any one of Claims 12 to 13, wherein the topographical pattern consists of a sealing, undulating, contiguous concentric structure.

15. The device of claim 13, wherein the microstructure and/or macrostructure serve as reservoirs.

16. The device of Claim 15, wherein the reservoirs are hydrophilic.

17. The device of Claim 15 or 16 wherein reservoirs are capillaries.

18. The device of Claim 7, wherein the body and/or the adhesive surface is a medical grade material.

19. A method for incorporating a printed circuit board into a body, wherein the method comprises the steps of:

(a) applying a layer of an uncured adhesive elastomer to a mould; (b) applying a first layer of an uncured body elastomer to the mould after a partial cure time of the layer of the uncured adhesive elastomer;

(c) embedding a printed circuit board into the first layer of the uncured body elastomer; and

(d) applying a second layer of the uncured body elastomer to the mould after a partial cure time of the of the first layer of the uncured body elastomer.

20. The method of Claim 19 wherein the printed circuit board comprises one or more perforations.

21. The method of any one of claims 19 and 21 wherein an edge of the printed circuit board is chamfered or filleted.

22. A method for incorporating a printed circuit board into a body, wherein the method comprises the steps of:

(a) applying a first layer of an uncured body elastomer to a mould;

(b) applying a second layer of an uncured body elastomer to the mould after a partial cure time of the first layer of the uncured body elastomer;

(c) embedding a printed circuit board into the second layer of the uncured body elastomer; and

(d) applying a second layer of an uncured adhesive elastomer to the mould after a partial cure time of the of the second layer of the uncured body elastomer.

23. A method for incorporating a printed circuit board into a body, wherein the method comprises the steps of:

(a) applying a layer of an uncured adhesive elastomer to a mould;

(b) applying an initial first layer of an uncured body elastomer to the mould after a partial cure time of the layer of the uncured adhesive elastomer; (c) partially embedding a printed circuit board into the initial first layer of the uncured body elastomer;

(d) applying a subsequent first layer of an uncured body elastomer to the mould after a partial cure time of the initial first layer of the uncured body elastomer; and

(e) applying a second layer of the uncured body elastomer to the mould after a partial cure time of the of the subsequent first layer of the uncured body elastomer.

24. A method for incorporating a printed circuit board into a body, wherein the method comprises the steps of:

(a) applying a first layer of an uncured body elastomer to a mould;

(b) applying an initial second layer of an uncured body elastomer to the mould after a partial cure time of the first layer of the uncured body elastomer;

(c) partially embedding a printed circuit board into the second layer of the uncured body elastomer;

(d) applying a subsequent second layer of an uncured body elastomer to the mould after a partial cure time of the initial second layer of the uncured body elastomer; and

(e) applying a layer of an uncured adhesive elastomer to the mould after a partial cure time of the of the subsequent second layer of the uncured body elastomer.

25. An adhesive elastomer comprising:

(a) a base;

(b) a cross-linker;

(c) a deadener; and

(d) one or more additives.

26. A method for preparing an adhesive elastomer, wherein the method comprises the steps of:

(a) incorporating a filler into one liquid component of an uncured adhesive elastomeric mixture;

(b) combining the remaining liquid components of the uncured adhesive elastomeric mixture with the component containing the filler;

(c) dispensing the mixed, uncured adhesive elastomer to a mould

27. A method for preparing an adhesive elastomer, wherein the method comprises the steps of:

(a) combining the liquid components of an uncured adhesive elastomeric mixture;

(b) incorporating a filler into the mixed, uncured adhesive elastomeric mixture;

(c) dispensing the mixed, uncured adhesive elastomer to a mould

28. A system for determining index data associated with a plurality of users, wherein the system comprises:

(a) a device processor operative to collect and transmit a set of data associated with the plurality of users;

(b) a parent processor operative to: (i) electronically receive the set of data associated with the plurality of users; (ii) collect a set of data associated with an event; (iii) combine and/or reconcile the set of data associated with the plurality of users and the set of data associated with the event; and (iv) compare the combined and/or reconciled set of data associated with the plurality of users and the set of data associated with the event with population data, corresponding to the set of data associated with the plurality of users, to determine the index data associated with the plurality of users; and

(d) a parent database to electronically store the index data; wherein the reconciled combination of the set of data associated with the plurality of users and the set of data associated with the event are for use in determining the index data associated with the plurality of users.

29. A method for use with data associated with a plurality of users, and for use with a determination of index data associated with the plurality of users, wherein the method comprises the steps of:

(a) operating a device processor to collect and transmit a set of data associated with the plurality of users;

(b) operating a parent processor to: (i) electronically receive the set of data associated with the plurality of users; (ii) collect a set of data associated with an event; (iii) combine and/or reconcile the set of data associated with the plurality of users and the set of data associated with the event; and (iv) compare the combined and/or reconciled set of data associated with the plurality of users and the set of data associated with the event with population data, corresponding to the set of data associated with the plurality of users, to determine the index data associated with the plurality of users; and

(c) electronically storing the index data in a parent database; wherein the user data and the reconciled set of data thereof are for use in determining the wellness indicator.

30. The method of any one of claims 28 and 29 whereby the set of data associated with the plurality of users comprises: heart rate, heart rate variability, breathing rate, stress, anxiety, sleep patterns, cognitive function, emotional profile, cardiac health, all-cause mortality, physical activity, and signature movement recognition of infectious disease.

31. The method of claim 29 whereby the set of data associated with an event comprises: Internet use patterns and behaviors search engine activity, websites most frequented, social networking activity, social media and media trends, time online.

32. The method of any one of claims 28 to 31 whereby the index data comprises: status and trends within and between individual and population level attitudes, behaviors, and health.

33. The method of any one of claims 28 to 32 whereby the population data comprises demographic, economic, and political trends.

Description:
A DEVICE, SYSTEM, METHOD, AND/OR COMPUTER READABLE MEDIUM FOR USE WITH BIOLOGICAL AND NONBIOLOGICAL DATA

FIELD OF THE INVENTION

[0001] The present invention relates generally to a device, system, method and computer readable medium for use with biological and nonbiological data, and more particularly to a device, system, method and computer readable medium for use with biological and nonbiological data to determine indicators and/or identify trends on an individual or population scale.

BACKGROUND OF THE INVENTION [0002] Wearable technology is a large and growing industry. In the prior art, such technology includes a variety of devices, such as watches, wrist bands, arm bands and glasses. While the various devices known in the art have grown in popularity, they may have been limited by a number of factors including, but not limited to, bulkiness, difficulty maintaining a device position relative to a user, device durability, and/or sensitivity of the measurements.

[0003] Wearable Devices

[0004] Wearable devices of the prior art have a variety of applications, including in the health, medical, or general wellness industries. Such devices have been used to measure certain biological signals of users (e.g., heart rate). However, the measurement of other biological signals, such as heart rate variability and electromyography, by wearable devices may have been limited or not possible due to one or more of the above limitations.

[0005] Heart rate variability ("HRV"), for example, is the physiological phenomenon of variation in the time interval between heartbeats. It is measured by the variation in the beat-to-beat interval. HRV may be used as a predictor of the health status of an individual. Devices of the prior art used to measure HRV, however, may be bulky and have limited mobility.

[0006] Electromyography may involve the measuring of electrical potential of the muscles of the human body. Electrical potential may preferably, but need not necessarily, allow for measurement of muscle engagement, training level, fatigue, and/or muscle fiber type. In addition, it may be used in the diagnosis and/or treatment of a number of muscular injuries and diseases. At present, electrical potential technology may primarily be used in rehabilitation and disease diagnosis; however, it may also be used to analyze muscle behaviour for recreational applications such as sports training, bodybuilding, and/or general fitness.

[0007] As may be appreciated by persons having ordinary skill in the art, electrical potential technology in the prior art may be impractical for individual use due to a number of potential issues. First, since sensors, such as electrodes, of the prior art are typically disposable and require replacement after each use, they may be designed to be separate from a main device (e.g., an electromyography device) and connected by cables. This design may be cumbersome to some users, for example athletes, and introduce signal noise into the electrical potential measurements. Second, in instances where the sensors (e.g., electrodes) of the prior art are embedded in clothing or straps, the reliability of the electrical potential measurements may be limited by the inexact placement of the electrodes in relation to specific points on an individual, an inability to isolate specific muscle heads, and/or the requirement to wash the clothing or straps between uses. Third, since the main electromyography device is generally located remote from the area of electrical potential measurement (e.g., clipped on at the waist of the individual), it may be large and rigid. The foregoing limitations of electrical potential technology of the prior art may limit the ability of wearable devices in the prior art to measure biological signals such as heart rate and hear rate variability. [0008] Surface Adhesion

[0009] It may also be appreciated by persons having ordinary skill in the art that the accuracy of electrical potential measurements may depend on the ability of a sensor (e.g., an electrode) to adhere to a surface of an individual. Adsorption theory and mechanical theory are two primary conceptual models used in describing adhesive bond strength. [0010] As may be known to persons skilled in the art, according to adsorption theory, intermolecular attractions may consist of secondary attractive forces exerted at an adhesive / adherend interface between a molecule of an adhesive and a neighbouring molecule of a substrate or adherend. The forces of attraction that hold individual molecules together may be known as "primary forces" whose source may preferably, but need not necessarily, be derived from covalent bonds (i.e., about 60-700 kJ/mol resulting in the sharing of electron pairs between atoms), ionic/electrostatic bonds (i.e., about 600-1000 kJ/mol in the form of crystals or salts), and/or metallic bonds (i.e., about 100-350 kJ/mol whereby mobile valence electrons are shared among fixed positively charged metallic atoms). "Secondary attractive forces", commonly known in the art as van der Waals forces, may preferably, but need not necessarily, be the resultant sum of dispersion forces (i.e., about 0.1 -40 kJ/mol based on interactions between fluctuating dipoles), polar forces (i.e., about 4-20 kJ/mol based on interactions of permanent dipoles), and/or hydrogen bonding (i.e., about 10-40 kJ/mol based on a special type of dipole-dipole attraction resulting from a hydrogen atom strongly bound to an atom of relatively higher electronegativity in the vicinity of another such bond) forces. The wearable devices of the prior art may not have been adapted to optimize the primary and/or secondary attractive forces to provide sufficient adhesion to various adherends, in different situations (e.g., variable moisture, activity, movement, etc.), and allow for repeated application and removal without affecting the force of adhesion between the device and adherend. In addition, adhesives of the prior art may not be adapted for long-term repeated use without a significant decrease in adhesive efficacy.

[0011] Data Applications [0012] In the prior art, abstract concepts are currently used in place of empirical indicia to monitor social trends. In addition, any monitoring of social trends has traditionally been conducted on an individual level instead of a population level. It may be desirable to monitor social trends using empirical data on both an individual and population level.

[0013] Recent advancements in the prior art have identified interactive circuits between neurological, neurophysiological, cardiological, and immunological systems, among others, which collectively connect a body so as to form one contiguous, communicative system. [0014] The simultaneous emergence of Internet derived meta-data and intelligent-data for capturing population level information on attitudes, behavior, and health, has preferably reinvigorated instantaneous and longitudinal monitoring of various population trends in relation to local, regional, and global occurrences. [0015] It may be advantageous to provide a device adapted to collect information from the interactive circuits that collectively connect a body with population level information to derive, for example, analytics on the state of a given individual or population.

[0016] Thus, there is a need for an improved device, system, method and/or computer readable medium for providing (i) devices with sensors adapted for use in a variety of situations, (ii) discreet wearable devices, (iii) forces sufficient to adhere the device to the adherend and maintain a position, (iv) adhesives for repeated used without a significant decrease in adhesive efficacy, and/or (v) identifying trends on an individual or population scale. What is needed is a device, system, method and/or computer readable medium that overcomes one or more of the limitations associated with the prior art. [0017] It is an object of the present invention to obviate or mitigate one or more of the aforementioned disadvantages and/or shortcomings associated with the prior art, to provide one of the aforementioned needs or advantages, and/or to achieve one or more of the aforementioned objectives of the invention.

SUMMARY OF THE INVENTION [0018] According to the invention, there is disclosed a system for determining a wellness indicator associated with a user. The system includes a device associated with the user, a parent processor, and a parent database. The device includes a sensor adapted to receive a set of data associated with the user and a device processor operative to collect and transmit the set of data associated with the user. The parent processor is operative to electronically receive the set of data associated with the user from the device processor, combine and/or reconcile the set of data associated with the user to generate user data, and compare the user data with population data, corresponding to the set of data, to determine the wellness indicator associated with the user. The parent database electronically store the user data and the wellness indicator. Thus, according to the invention, the system is operative to facilitate the determination of the wellness indicator associated with the user. [0019] According to the invention, there is provided a system for determining a wellness indicator associated with a user. The system includes a device, a parent processor, and a parent database. The device comprises a first sensor adapted to receive a first set of data associated with the user, a second sensor adapted to receive a second set of data associated with the user, and a device processor operative to collect and transmit the first and second sets of data associated with the user. The parent processor operative to electronically receive the first and second sets of data associated with the user from the device processor, combine and/or reconcile the first and second sets of data associated with the user to generate user data, and compare the user data with population data, corresponding to the first and second sets of data, to determine the wellness indicator associated with the user. The parent database to electronically store the user data and the wellness indicator. Thus, the system is operative to facilitate the determination of the wellness indicator associated with the user. [0020] According to an aspect of one preferred embodiment of the invention, the data associated with the user may preferably, but need not necessarily, comprise: heart rate, heart rate variability, breathing rate, stress, anxiety, sleep, focus, cognition function, cardiac health, stress loads on structures, location, movement, posture, infection status, immune status, activity, temperature, respiration, activity, muscle information, neurologic information, serologic information, and/or epigenetic information.

[0021] According to the invention, there is disclosed a device for use in determining a wellness indicator associated with a user. The device includes a sensor operative to receive a set of data associated with the user. The device also includes a device processor operative to collect the set of data associated with the user from the sensor and electronically transmit the set of data associated with the user to a parent processor in order to: (i) combine and/or reconcile the set of data associated with the user to generate user data; and (ii) compare the user data with population data, corresponding to the set of data, to determine the wellness indicator associated with the user. [0022] According to the invention, there is disclosed a method for use with data associated with a user, and for use with a determination of a wellness indicator associated with the user. The method includes: a step of operating a sensor to receive a set of data associated with the user; a step of operating a device processor to collect the set of data associated with the user from the sensor and transmit the set of data associated with the user; a step of operating a parent processor to electronically receive the first set of data associated with the user from the device processor to: (i) combine and/or reconcile the set of data associated with the user to generate user data; and (ii) compare the user data with population data, corresponding to the set of data, to determine the wellness indicator associated with the user; and a step of electronically storing the user data and the wellness indicator in a parent database. Thus, the method uses the user data and the reconciled set of data thereof to determine the wellness indicator.

[0023] According to the invention, there is disclosed a computer readable medium on which is physically stored executable instructions for use in association with data associated with a user; for use with determining a wellness indicator associated with the user; wherein the executable instructions comprise processor instructions for a device processors of a device and/or a parent processor. The executable instructions are such as to, upon execution: (a) collect and/or electronically communicate a set of data associated with the user from the device processor to the parent processor; (b) combine and/or reconcile the set of data associated with the user to generate user data; (c) compare the user data with population data, corresponding to the set of data, to determine the wellness indicator associated with the user; and (d) electronically store the user data and the wellness indicator in a parent database. Thus, the computer readable medium operatively facilitates determining the wellness indicator.

[0024] According to the invention, there is disclosed a device for adhering to a surface having a surface shape. The device includes: (a) a body adapted to conform to the surface shape; (b) one or more components embedded in the body; and (c) an adhesive surface, integral with the body, comprising a topographical pattern and adapted to removeably adhere the device to the surface.

[0025] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, include a body with a rigid printed circuit board. [0026] According to an aspect of one preferred embodiment of the invention, the device may preferably, but need not necessarily, include a body with a flexible printed circuit board.

[0027] According to an aspect of one preferred embodiment of the invention, the body of the device may preferably, but need not necessarily, include conducting particles.

[0028] According to an aspect of one preferred embodiment of the invention, the body of the device may preferably, but need not necessarily, include an elastomer, foam or plastic.

[0029] According to an aspect of one preferred embodiment of the invention, the topographical pattern of the device may preferably, but need not necessarily, cover at least a portion of the adhesive surface.

[0030] According to an aspect of one preferred embodiment of the invention, the topographical pattern of the device may preferably, but need not necessarily, be a singular contiguous microstructure and/or macrostructure.

[0031] According to an aspect of one preferred embodiment of the invention, the topographical pattern of the device may preferably, but need not necessarily, consist of a sealing, undulating, contiguous concentric structure.

[0032] According to an aspect of one preferred embodiment of the invention, the microstructure and/or macrostructure of the device may preferably, but need not necessarily, serve as reservoirs. [0033] According to an aspect of one preferred embodiment of the invention, the reservoirs of the device may preferably, but need not necessarily, be hydrophilic. [0034] According to an aspect of one preferred embodiment of the invention, the reservoirs of the device may preferably, but need not necessarily, be capillaries.

[0035] According to an aspect of one preferred embodiment of the invention, the body and/or the adhesive surface of the device may preferably, but need not necessarily, be a medical grade material.

[0036] According to the invention, there is provided a method for incorporating a printed circuit board into a body. The method includes: (a) a step of applying a layer of an uncured adhesive elastomer to a mould; (b) a step of applying a first layer of an uncured body elastomer to the mould after a partial cure time of the layer of the uncured adhesive elastomer; (c) a step of embedding a printed circuit board into the first layer of the uncured body elastomer; and (d) a step of applying a second layer of the uncured body elastomer to the mould after a partial cure time of the of the first layer of the uncured body elastomer.

[0037] According to an aspect of one preferred embodiment of the invention, the printed circuit board used in the method may preferably, but need not necessarily, include one or more perforations.

[0038] According to an aspect of one preferred embodiment of the invention, the printed circuit board used in the method may preferably, but need not necessarily, include an edge that is chamfered or filleted.

[0039] According to the invention, there is provided a method for incorporating a printed circuit board into a body. The method includes: (a) a step of applying a first layer of an uncured body elastomer to a mould; (b) a step of applying a second layer of an uncured body elastomer to the mould after a partial cure time of the first layer of the uncured body elastomer; (c) a step of embedding a printed circuit board into the second layer of the uncured body elastomer; and (d) a step of applying a second layer of an uncured adhesive elastomer to the mould after a partial cure time of the of the second layer of the uncured body elastomer. [0040] According to the invention, there is provided a method for incorporating a printed circuit board into a body. The method includes: (a) a step of applying a layer of an uncured adhesive elastomer to a mould; (b) a step of applying an initial first layer of an uncured body elastomer to the mould after a partial cure time of the layer of the uncured adhesive elastomer; (c) a step of partially embedding a printed circuit board into the initial first layer of the uncured body elastomer; (d) a step of applying a subsequent first layer of an uncured body elastomer to the mould after a partial cure time of the initial first layer of the uncured body elastomer; and (e) a step of applying a second layer of the uncured body elastomer to the mould after a partial cure time of the of the subsequent first layer of the uncured body elastomer. [0041] According to the invention, there is provided a method for incorporating a printed circuit board into a body. The method includes: (a) a step of applying a first layer of an uncured body elastomer to a mould; (b) a step of applying an initial second layer of an uncured body elastomer to the mould after a partial cure time of the first layer of the uncured body elastomer; (c) a step of partially embedding a printed circuit board into the second layer of the uncured body elastomer; (d) a step of applying a subsequent second layer of an uncured body elastomer to the mould after a partial cure time of the initial second layer of the uncured body elastomer; and (e) a step of applying a layer of an uncured adhesive elastomer to the mould after a partial cure time of the of the subsequent second layer of the uncured body elastomer.

[0042] According to the invention, there is provided an adhesive elastomer that includes: (a) a base; (b) a cross-linker; (c) a deadener; and (d) one or more additives. [0043] According to the invention, there is provided a method for preparing an adhesive elastomer. The method includes: (a) a step of incorporating a filler into one liquid component of an uncured adhesive elastomeric mixture; (b) a step of combining the remaining liquid components of the uncured adhesive elastomeric mixture with the component containing the filler; and (c) a step of dispensing the mixed, uncured adhesive elastomer to a mould.

[0044] According to the invention, there is provided a method for preparing an adhesive elastomer. The method includes: (a) a step of combining the liquid components of an uncured adhesive elastomeric mixture; (b) a step of incorporating a filler into the mixed, uncured adhesive elastomeric mixture; and (c) a step of dispensing the mixed, uncured adhesive elastomer to a mould.

[0045] According to the invention, there is provided a system for determining index data associated with a plurality of users. The system includes a device processor, a parent processor and a parent database. The device processor is operative to collect and transmit a set of data associated with the plurality of users. The parent processor is operative to: (i) electronically receive the set of data associated with the plurality of users; (ii) collect a set of data associated with an event; (iii) combine and/or reconcile the set of data associated with the plurality of users and the set of data associated with the event; and (iv) compare the combined and/or reconciled set of data associated with the plurality of users and the set of data associated with the event with population data, corresponding to the set of data associated with the plurality of users, to determine the index data associated with the plurality of users. The parent database is operative to electronically store the index data. Thus, the reconciled combination of the set of data associated with the plurality of users and the set of data associated with the event are for use in determining the index data associated with the plurality of users.

[0046] According to the invention, there is disclosed a method for use with data associated with a plurality of users, and for use with a determination of index data associated with the plurality of users. The method includes: (a) a step of operating a device processor to collect and transmit a set of data associated with the plurality of users; (b) a step of operating a parent processor to: (i) electronically receive the set of data associated with the plurality of users; (ii) collect a set of data associated with an event; (iii) combine and/or reconcile the set of data associated with the plurality of users and the set of data associated with the event; and (iv) compare the combined and/or reconciled set of data associated with the plurality of users and the set of data associated with the event with population data, corresponding to the set of data associated with the plurality of users, to determine the index data associated with the plurality of users; and (c) a step of electronically storing the index data in a parent database. Thus, the user data and the reconciled set of data thereof are for use in determining the wellness indicator.

[0047] According to an aspect of one preferred embodiment of the invention, the set of data associated with the plurality of users used in the method may preferably, but need not necessarily, include: heart rate, heart rate variability, breathing rate, stress, anxiety, sleep patterns, cognitive function, emotional profile, cardiac health, all-cause mortality, physical activity, and signature movement recognition of infectious disease.

[0048] According to an aspect of one preferred embodiment of the invention, the set of data associated with an event, may preferably but need not necessarily include: Internet use patterns and behaviors search engine activity, websites most frequented, social networking activity, social media and media trends, time online.

[0049] According to an aspect of one preferred embodiment of the invention, the index data may preferably but need not necessarily include: status and trends within and between individual and population level attitudes, behaviors, and health. [0050] According to an aspect of one preferred embodiment of the invention, the population data preferably, but need not necessarily, includes demographic, economic, and political trends.

[0051] Other advantages, features and characteristics of the present invention, as well as methods of operation and functions of the related elements of the apparatus and method, and the combination of steps, parts and economies of manufacture, will become more apparent upon consideration of the following detailed description and the appended claims with reference to the accompanying drawings, the latter of which are briefly described herein below.

BRIEF DESCRIPTION OF THE DRAWINGS [0052] The novel features which are believed to be characteristic of the apparatus and method according to the present invention, as to their structure, organization, use, and method of operation, together with further objectives and advantages thereof, will be better understood from the following drawings in which presently preferred embodiments of the invention will now be illustrated by way of example. It is expressly understood, however, that the drawings are for the purpose of illustration and description only, and are not intended as a definition of the limits of the invention. In the accompanying drawings:

[0053] FIG. 1 is a schematic diagram of a system and device for collecting and/or analyzing data associated with a user according to one preferred embodiment of the invention;

[0054] FIG. 2 is a schematic diagram of components of the system and device of FIG. 1;

[0055] FIGS. 3A and B are side elevation cross-sectional and bottom plan views, respectively, of the device in accordance with a preferred embodiment of the invention;

[0056] FIGS. 4A and B are side elevation views, non-flexed and flexed respectively, of the printed circuit board in accordance with a preferred embodiment of the invention; [0057] FIG. 5 is a side elevation cross-sectional view of a capacitive sensor in accordance with a preferred embodiment of the invention;

[0058] FIG. 6 is a non-alert focus and stress interface presented by a graphical user interface ("GUI") device of the system of FIG. 1;

[0059] FIG. 7 is an autonomous user state interface presented by a GUI device of the system of FIG. 1; [0060] FIGS. 8A to D are, taken together, graphs showing high coherence (FIGS. 8A and B), and low coherence (FIGS. 8C and D) in accordance with a preferred embodiment of the invention;;

[0061] FIG. 9 is an alert stress interface presented by a GUI device of FIG. 1; [0062] FIGS. 10A and B are, taken together, a flowchart of an over-arching method according to a preferred embodiment of the invention;

[0063] FIG. 11 is a depiction of macro-topology and micro-topology in the prior art;

[0064] FIG. 12 is a perspective view of macro-topology applied to the adhesive pad of FIG. 3A; [0065] FIGS. 13A and B are a plan view and perspective view, respectively, of the adhesive pad with concentric rings forming a gasket and microgaskets in accordance with a preferred embodiment of the invention;

[0066] FIG. 14 is a perspective view of wells in the gaskets or microgaskets of the adhesive pad of FIG. 13B; [0067] FIG. 15 is a plan view of a biomimetic coral pattern applied to an adhesive pad in accordance with a preferred embodiment of the invention;

[0068] FIGS. 16A and B are schematic diagrams depicting the relationship between intrinsic data, extrinsic data and index data for individualized and population-level users, respectively in accordance with a preferred embodiment of the invention; [0069] FIG. 17 is a flowchart of a method for generating index data according to a preferred embodiment of the invention in accordance with a preferred embodiment of the invention;

[0070] FIG. 18 is a schematic diagram depicting collection and analysis of intrinsic data in accordance with a preferred embodiment of the invention;

[0071] FIG. 19 is a schematic diagram depicting psychophysiological data for use in accordance with a preferred embodiment of the invention;

[0072] FIG. 20 is a schematic diagram of a printed circuit board layout showing perforations in accordance with a preferred embodiment of the invention; [0073] FIGS. 21A to F are plan and side views of a device in accordance with a preferred embodiment of the invention;

[0074] FIGS. 22A to C are plan and side views of a piezoelectric sensor in accordance with a preferred embodiment of the invention;

[0075] FIGS. 23A and B are side views of a device in accordance with a preferred embodiment of the invention;

[0076] FIGS. 24A and B are side views of a device in accordance with a preferred embodiment of the invention;

[0077] FIGS. 25A to C are a side view of the device, a plan view of the piezoelectric sensor, and a side view of the piezoelectric sensor, respectively, in accordance with a preferred embodiment of the invention; [0078] FIG. 26 is a side view of an arm of a user with multiple devices in accordance with a preferred embodiment of the invention;

[0079] FIG. 27 is a schematic diagram of a plurality of devices for a virtual reality application in accordance with a preferred embodiment of the invention;

[0080] FIG. 28A and B are schematic diagrams of the application of FIG. 27 for use with one user and more than one user;

[0081] FIG. 29 is an open air cure process for manufacturing the device in accordance with a preferred embodiment of the invention;

[0082] FIG. 30 is a modified open air cure process for manufacturing the device in accordance with a preferred embodiment of the invention;

[0083] FIG. 31 is an injection moulding process for manufacturing the device in accordance with a preferred embodiment of the invention;

[0084] FIG. 32 is a platinum catalyst for use in accordance with a preferred embodiment of the invention;

[0085] FIG. 33 is a machine learning process in accordance with a preferred embodiment of the invention;

[0086] FIG. 34 is a side view of a device for haptic feedback in accordance with a preferred embodiment of the invention; [0087] FIG. 35 is a side view of a device for haptic feedback in accordance with a preferred embodiment of the invention;

[0088] FIG. 36 is a schematic diagram of a device for haptic communication in accordance with a preferred embodiment of the invention; [0089] FIG. 37 is a schematic diagram of a device for haptic guided navigation in accordance with a preferred embodiment of the invention;

[0090] FIGS. 38A and B are plan and side views, respectively, of a device for use in the application of FIG. 37; and

[0091] FIG. 39 is a graph of force (lbs) vs. time (seconds). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0092] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles of the present invention. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the invention. In the description, like parts are marked throughout the specification and the drawings with the same respective reference numerals. The drawings are not necessarily to scale and in some instances proportions may have been exaggerated in order to more clearly depict certain embodiments and features of the invention.

[0093] In this disclosure, a number of terms and abbreviations are used. The following definitions of such terms and abbreviations are provided. [0094] As used herein, a person skilled in the relevant art may generally understand the term "comprising" to generally mean the presence of the stated features, integers, steps, or components as referred to in the claims, but that it does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof. [0095] As used herein, a person skilled in the art may understand the term "flexible" to generally mean the ability of an object, including preformed embodiments of the present invention, to bend about at least one axis, without significant elongation or breakage.

[0096] As used herein, a person skilled in the art may understand the term "soft" to generally mean various states of matter with low resistance to external force or one that easily deforms; not hard or firm to the touch.

[0097] In order that the invention may be more fully understood, it will now be described, by way of example, with reference to the accompanying drawings in which FIG. 1 through FIG. 39 illustrate embodiments of the present invention.

[0098] The figures are not to scale and some features may be exaggerated or minimized to show details of particular elements while related elements may have been eliminated to prevent obscuring novel aspects. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention. [0099] Referring to FIG. 1, there is shown a system 50 for use with a device 100 adapted to receive information from a user 20 (i.e., a user 20 may include an individual or a plurality of users 20). FIGS. 1, 2 and 3A through 4B show a device 100 for use in association with the system 50 and the method 500 and/or under influence of a related computer readable medium 130. FIGS. 6 through 9 show a graphical representation of an interface which may preferably be presented to the user 20. FIG. 5 shows a capacitive sensor for use in association with the device 100 . FIGS. 10A and 10B show steps performed according to a related method 500. FIGS. 11 through 15 show topologies of the adhesive pad for use in association with the device 100. FIGS. 16, 18 and 19 show schematic diagrams of a process for referencing intrinsic data with extrinsic data to generate index data. FIG. 17 shows steps performed according to a related method 700. FIG. 20 shows a printed circuit board in accordance with the present invention. FIGS. 21 through 25 show preferable embodiments of a device and sensor. FIGS. 26 through 28 and FIGS. 34 through 38 are schematic diagrams of preferable applications of the invention. FIGS. 29 through 31 are processes for the manufacture of the device. FIG 32 is a platinum catalyst. FIG. 33 is a machine learning process. FIGS. 38A and B show an alternate embodiment of the device for use in the application of FIG. 37. FIG. 39 is a graph of force versus time.

[00100] Some parts of the system 50 depicted in FIG. 1 may be provided at a remote location. Preferably, and as best seen in FIG. 1, the system 50 includes a device subsystem 60, a parent device subsystem 70, and an accessory device subsystem 80.

[00101] In FIGS. 1 and 2, the system 50 is shown in use with a communication network 300. The communication network 300 may include satellite networks (e.g., GPS), terrestrial wireless networks, and the Internet. The communication of data between the device subsystem 60, the parent device subsystem 70 and/or the accessory device subsystem 80 may also be achieved via one or more wired means of transmission (e.g., docking the device 100 in a base station of the parent device subsystem 70), or other physical means (e.g., a Universal Serial Bus cable and/or flash drive) of transmission. Persons having ordinary skill in the art will appreciate that the system 50 includes hardware and software. [00102] FIG. 2 schematically illustrates, among other things, that the device subsystem 60 includes a device for measuring and/or receiving biological data or nonbiological data associated with the user and a device processor 90a, a transmitter-receiver 61 , a device database 62, a locator 63, at least one physiological sensor 64 (e.g., electrode, piezoelectric, photoplethysmography), a strain gauge 65, device input-output components (e.g., display, auditory, and/or tactile components) 66, a gyroscope 67, an accelerometer 68, a filter 69, a vibration generator 91 , heating 92, magnometer 93, and/or a computer readable medium (e.g., an onboard device processor-readable memory) 130a local to the device processor 90a. Each of the device processor 90a, transmitter-receiver 61 , device database 62, locator 63, sensor 64, strain gauge 65, device input-output components 66, gyroscope 67, accelerometer 68, filter 69, vibration generator 91 , heating 92, and magnometer 93 may collectively be referred to as a component(s) 1 14. The parent device subsystem 70 includes a parent processor 90b (which may preferably be provided as a component of a tablet, laptop, computer, phone, server or any other device that may be known to a person of skill in the art), a parent database 71 , input-output devices (e.g., a printer for generating reports, etc.) 72, and/or a computer readable medium (e.g., a processor-readable memory) 130b local to the parent processor 90b. The accessory device subsystem 80 may include accessory devices 81 (e.g., devices 100, heart rate monitors, laptops, tablets, headphones, global positioning systems, watches, wrist bands, glasses with integrated displays and/or other devices that may be known to persons skilled in the art), accessory device processors 82 and/or remote databases 83.

[00103] Device Subsystem

[00104] As best seen in FIGS. 1 and 2, the device 100 preferably includes the device database 62. As shown in FIG. 2, it also includes the transmitter-receiver 61, the locator 63, the sensor 64, the strain gauge 65, the device input-output component 66, the gyroscope 67, the accelerometer 68, and the filter 69.

[00105] Preferably, the device 100 uses the at least one sensor 64 to automatically receive biological data 22 and/or nonbiological data 28 associated with the user 20. In some preferable embodiments, if the sensor 64 is an electrode the sensor 64 preferably comprises any conductive material known to persons skilled in the art for use in such an application such as, but not limited to, silver, gold, or stainless steel. Using the transmitter-receiver 61, the device processor(s) 90a may wirelessly communicate via the communication network 300 (for example, by the Bluetooth™ Low Energy proprietary open wireless technology standard which is managed by the Bluetooth Special Interest Group of Kirkland, Washington) with - or may be wired to communicate with - the parent processor(s) 90b and/or the accessory device processor(s) 82.

[00106] Preferably, the parent processor(s) 90b communicates via the communication network 300 with the accessory device processor(s) 82 to facilitate transmission of the accessory device data 24 thereto. In some embodiments, the device processor(s) 90a may connect to the accessory device processor(s) 82 via the communication network 300. The device processor(s) 90a may transmit all the biological data 22 and/or nonbiological data 28 (either the entire set of data 22, 28 or any portions that have not been previously sent to the parent processor(s) 90b) to the accessory device processor(s) 82 and stored in the remote databases 83. Alternatively, the accessory device processor(s) 82 may transmit all the accessory device data 24 (either the entire set of accessory device data 24 or any portions that have not been previously sent to the parent processor(s) 90b) to the device processor(s) 90a and stored in the device database 62. This transfer of data 22, 24, 28 preferably occurs while the device 100 is receiving biological data 22 or nonbiological data 28 associated with the user 20. [00107] In a preferred embodiment, the device subsystem 60 may comprise a hardware and/or software application that allows for the receipt of data 22, 28 associated with the user 20 that has the capability to use the 802.1 1 protocol, Bluetooth communication and/or another linkage. For example, cellular communication and/or the communication network 300 may be used. Additional hardware and/or software applications may: (i) be enacted upon associating the device 100 with a user 20; (ii) connect wirelessly to the parent processor(s) 90b (e.g., via Bluetooth, Wi-Fi and/or another linkage); (iii) collect the accessory device data 24 from the accessory device processor(s) 82, and/or collect biological data 22, nonbiological data 28 and/or accessory device data 24 from the parent processor(s) 90b and/or from the parent database 71 ; and/or (iv) store the accessory device data 24, the biological data 22, and the nonbiological data 28 in the device database 62 for subsequent transmission to the parent database 71. [00108] The biological data 22, nonbiological data 28 and/or the accessory device data 24 stored in the device database 62 may be transmitted to the parent database 71 and/or the parent processors 90b at regular intervals throughout the duration of association of the device 100 with the user 20, at regular intervals throughout each day, at discretionary or event triggered intervals (e.g., stress, heart rate increase, cardiac event detection) and preferably at least by the end of each day. In an alternate embodiment, the device 100 may be a pass-through device, instead of or in addition to functioning as a storage device (e.g., via the device database 62). Instead of, or in addition to, storing biological data 22, nonbiological data 28 and/or accessory device data 24 in the device database 62, the data 22, 24, 28 may preferably be transmitted in real-time using the transmitter-receiver 61 to the parent processor(s) 90b and/or the parent database 71.

[00109] Device

[00110] Referring now to FIG. 3 A, there is depicted a device 100 for the detection and measurement of biological data 22 (not shown) and/or nonbiological data 28 (not shown). The device 100 preferably comprises a body 1 10 which contains a rigid or flexible circuit substrate 1 12 (alternately a printed circuit board 1 12) with one or more components 1 14 and one or more power supplies 1 16 (e.g., solar cells 1 16a) placed off of at least one line of flexation 1 18. In some embodiments, two or more lines of flexation 1 18 may preferably be positioned parallel relative to one another. In alternate preferable embodiments, however, the device 100 does not comprise a line of flexation 1 18 with respect to the one or more components 1 14. [00111] The bottom of the device 100 or contact surface, as depicted in FIGS. 3 A and

B, preferably comprises a reusable adhesive pad 120 surrounding at least one sensor 64. It will be understood that sensors 64 need not be in contact with the adherend, but need only be in sufficient proximity to the adherend to collect biological data 22 and/or nonbiological data 28. Some preferable embodiments of the device 100 may not comprise sensors 64.

[00112] In some preferred embodiments, as shown in FIG. 3 A, the body 1 10 is bonded to the adhesive pad 120 and components 114 by any means known to persons skilled in the art, including but not limited to, mechanical interlocking, cyanoacrylate, acrylic, epoxy, or silicone adhesive, thermal joining, chemical, or any combination thereof. In a preferred embodiment, a platinum-cure silicone body 110 may be bonded to a tacky platinum-cure silicone adhesive pad 120 by chemical bonding which may occur, unaided, when for example a platinum-cure silicone body 1 10 is over-moulded on the platinum-cure silicone adhesive pad 120 or vice versa, In preferable embodiments, chemical bonding of the body 1 10 and the adhesive pad 120 forms a contiguous single body. [00113] As shown in FIGS. A and 4B, the flexible circuit substrate 112 may preferably comprise any flexible material such as, but not limited to, polyimide or silicone with any conductive material as electrical connections such as, but not limited to, silver, gold, copper, aluminum, silver ink, graphite ink, carbon ink, or any combination thereof. In an alternate preferred embodiment, the substrate 1 12 comprises a soft and/or the same material as the body 1 10 of the device 100 - that is, any soft, biocompatible unsaturated or saturated elastomer, foam, or plastic, including but not limited to polyurethane, neoprene, or platinum- cured silicone. In such an embodiment, the connections between the components 114 is preferably designed to withstand the strain that may be caused by the flexation of the body 1 10. Such designs may preferably comprise the use of conducting micro- or nanoparticles embedded in soft, flexible material or providing a waved connection such that the connections will straighten before undergoing any significant flexation. The connections may be manufactured using any method known to persons skilled in the relevant art such as, but not limited to, screen printing, ink-jet printing, milling, photolithography, pen plotting, or any combination thereof. The substrate 1 12 and geometry of the substrate 1 12 may also preferably be designed to flex along lines 1 18, along arrows A and A', with respect to a deforming surface such as but not limited to the human epidermis, without damaging the device 100 or causing the adhesive pad 120 (not shown) to detach. Components 1 14 (such as the device processor(s) 90a - not shown) are preferably positioned away from the lines of flexation 1 18 to facilitate flexing of the device 100 and pivoting of the components 114 about the lines of flexation 118.

[00114] As illustrated in FIGS. 3A and B, the device 100 comprises a body 1 10 that is a biocompatible unsaturated or saturated elastomer, foam, or plastic, including but not limited to polyurethane, neoprene, or platinum-cured silicone. In preferable embodiments, the body 1 10 is a soft and flexible platinum cure silicone rubber with an embedded flexible substrate 1 12 that preferably comprises polyimide (as described above). The device 100 also preferably comprises components (alternately known as electrical components) 1 14 that may be conventional, rigid electrical components. The components 114 may preferably be positioned away from the at least one line of flexation 118 (and/or parallel to the width of the device 100) on the flexible substrate 1 12, to allow the device 100 to flex along lines 1 18 (and the components 1 14 to pivot about the lines of flexation 1 18) during application with respect to a deforming surface such as but not limited to the human epidermis, without damaging the device 100 or causing the adhesive pad 120 to detach. Additionally, some components 1 14 may be replaced by flexible variants such as, but not limited to, conventional rigid resistors being replaced with semi-conductive carbon ink. Alternately, some preferable embodiments of the device 100 do not include the at least one line of flexation 1 18 and, accordingly, the components 1 14 need not be placed with respect thereto. The electrical components 114 may preferably be connected to an electrical connection on the substrate (not shown) by any electrically conductive method known to persons skilled in the relevant art such as, but not limited to, conventional soldering or conductive ink or epoxy and may preferably be placed in any method known to persons skilled in the relevant art such as, but not limited to, automatic, robotic, manual, printing, photolithography, or any combination thereof.

[00115] Referring to FIG. 3 A, both the adhesive pad 120 and the at least one sensor 64 may preferably be a tacky platinum cure silicone with the at least one sensor 64 and/or having embedded graphite particles. The power storage device 1 16 may preferably be a lithium polymer battery which may be charged by any means known to persons skilled in the art, including solar cell(s) 1 16a positioned on a surface of the device 100. In some embodiments, the power storage 116 (and solar cell 1 16a) may be rigid and/or located away from the lines of flexation 1 18. In some preferable embodiments, the power storage 1 16 is external to the device 100. As shown in FIG. 3B, preferable embodiments of the device 100 may comprise two sensors 64 which may preferably measure electromyography and/or skin impedance data using a filter (not shown). The device 100 preferably wirelessly communicates - for example, by Bluetooth™ Low Energy - using a transmitter-receiver 61 (not shown). In this way, the device 100 is preferably not physically tethered to an external unit for information transfer or power and may remain completely sealed. Such a fully integrated design preferably allows water and dust proofing and may afford additional robustness and shock-resistance to facilitate use of the device 100 in a broader range of activities. An integrated design may also preferably eliminate the requirement for the user 20 to connect cables to the device 100 for charging and/or data transfer.

[00116] Preferably, the electrical components 1 14 may be adapted to amplify, rectify, and/or filter electromyography (EMG) data collected by the at least one sensor 64.

[00117] The adhesive pad 120 is preferably composed of a reusable, adherend-safe (e.g., skin safe, inanimate surface safe, etc.) adhesive. In a preferred embodiment, the adhesive may be a tacky platinum-cure liquid silicone rubber having a Shore® Durometer (00 scale) of 0 to 95 and preferably a range of Shore 10 to 50.

[00118] The tackiness may preferably be achieved by mixing a polyorganosiloxane ~ preferably polydimethylsiloxane but may also comprise poly(methylphenyl)siloxane, polydimethylsiloxane-block-polydiphenylsiloxane, polymethylphenylsiloxane-block- polydimethylsiloxane, polymethylphenylsiloxane-block-polydiphenylsiloxane or other polyorganosiloxane permutations thereof including both linear and branched embodiments of said polymers— with an uncured platinum-cure liquid silicone rubber, that is, a silicone rubber that is cured by a platinum-catalyzed cure system (e.g., Ecoflex® GEL by Smooth- On, Inc. Pennsylvania USA). [00119] As may be known to persons skilled in the art, tacky platinum-cure silicone rubber is non-degrading, hypoallergenic, soft, flexible, reusable with a soap and water rinse, and/or leaves no residue on the skin. As may further be known by persons skilled in the art, tacky platinum-cure silicone may be more surface insensitive than other adhesives and may require less preparation prior to application on a surface. If the adherend is skin, common hygiene practices preferably keeps the skin clean enough for secure application of the tacky platinum-cure silicone adhesive. Preferably no physical tethers are required to attach the device 100 to the user's skin during operation.

[00120] The at least one sensor 64 may preferably be embedded in and surrounded by the body 1 10 or protruding from, or at surface level relative to the adhesive pad 120 and may comprise any adherend-safe conductive material known to persons skilled in the art (as described in more detail below) such as, but not limited to, silver, gold, or stainless steel (as best depicted in FIG. 5). Persons skilled in the art may appreciate that the sensor 64 of FIG. 5 preferably comprises a conductive plate 126 operatively connected to a conductive adhesive pad 128. The conductive adhesive pad 128 preferably comprises conductive rubber only, conductive fabric embedded in and/or coated with the conductive rubber, conductive foam, conductive polymers, metallic wires embedded in and/or coated with the conductive rubber, and/or metallic buttons or snaps embedded in and/or coated with the conductive rubber. [00121] The at least one sensor 64 may preferably be configured as a flexible electrode by using any conductive material such as, but not limited to, foil, mesh, chain link, foam, weave, fabric, or winding. The at least one sensor 64 may preferably be made flexible and/or soft by embedding particles and/or fibers of the conductive material in a soft and/or flexible material, such as those used in the body 1 10 and/or adhesive pad 120. In one embodiment, the conductive particles and/or fibers may be embedded in the tacky platinum cure silicone rubber to allow the at least one sensor 64 to additionally act as an electrode adhesive pad in conjunction or without the adhesive pad 120 (as best shown in FIG. 5). In such embodiments, the at least one sensor 64 may preferably comprise polyurethane, neoprene, and/or platinum-cure silicone rubber with embedded conductive particles.

[00122] Preferably, the conductive material of the adhesive pad 120 may comprise polydimethylsiloxane ("PDMS"), not more than about 50% by weight for the solid-state additives combined, as follows:

• PDMS / carbon black ("CB") - between about 1 to about 50 wt% of all rubber components with CB of specific surface area about 50 to about 400 m 2 g "1 ;

• PDMS / graphite - between about 1 to about 50 wt% of all rubber components with CB of specific surface area of about 50 to about 400 m 2 g "1 ;

• PDMS / graphite - between about 1 to about 50 wt% of all rubber components with graphite of specific surface area of about 50 to about 400 m 2 g "1 ;

• PDMS / multi-walled carbon nanotubes ("CNT") - between about 1 to about 15 wt% of all rubber components with multi-walled CNT of diameter of about 8 to about 50 nm and length about 1 to about 50 μηι; • PDMS / single-walled carbon nanotubes - between about 1 to about 15 wt% of all rubber components with single-walled CNT of diameter of about 1 to about 8 nm and length of about 0.3 to about 50 μπι;

• PDMS / silver nano wires ("AgNW") - between 0.1-5.0 wt% of all rubber components with AgNW of diameter of about 30 to about 200 nm and length about 0.5 to about 100 μιη;

• PDMS / silver spherical / geometric nanoparticles ("AgNP") - between about 0.1 to about 5.0 wt% of all rubber components with AgNP of diameter of about 10 to about 50 nm;

• PDMS / silver oxide spherical / geometric nanoparticles ("AgONP") - between about 0.1 to about 5.0 wt% of all rubber components with AgONP of diameter of about 10 to about 50 nm;

• PDMS / copper spherical / geometric nanoparticles ("CuNP") - between about 0.1 to about 5.0 wt% of all rubber components with CuNP of between about 10 to about 50 nm;

• PDMS / noble metal quantum clusters ("NM QCs") - between about 0.1 to about 10.0 wt% of all rubber components with NM QCs of between about 5 to about 100 noble metal atoms and associated ligands; and

• PDMS / pyrogenic silica - between 1-5 wt% of all rubber components with silica of specific surface area 50—400 m g " . [00123] As may be understood by persons of skill in the art, the PDMS in the formulations set out above may be replaced with acrylonitrile butadiene styrene ("ABS") plastic and/or epoxy.

[00124] Preferably, the mode of signal transduction of the sensor 64, configured as an electrode, is conductive or capacitive. Persons of skill in the art may appreciate that a capacitive sensor (e.g., electrode) preferably comprises a conductive plate 126 and a dielectric material 128 (alternately the conductive adhesive pad 128) as shown in FIG. 5. Preferably, the adhesive pad 120 may also be used as the dielectric material 128. In some preferable embodiments, the sensor 64 may be surrounded by the adhesive pad 120. In other preferable embodiments, the device 100 does not include a sensor 64.

[00125] In some embodiments, the body 110 and/or adhesive pad 120 may preferably also be embedded with silver in any form known to persons skilled in the art including, but not limited to, raw silver, silver nanowires, silver zeolites, silver containing clays, silver containing chemical solution, silver nanoparticles, and any combination thereof. Embedding silver in the body 1 10 and/or adhesive pad 120 may preferably provide antibacterial properties. In a preferred embodiment, the silver nanoparticles may be present in at least a concentration of about 33 nM. As may be known to persons skilled in the art, the size of the nanoparticle may partly determine the release rate; smaller nanoparticles have a higher surface area to volume ratio and release silver ions faster, but also degrade faster. The coating, surface, and shape of the nanoparticles may also be used to control the release rate.

[00126] Preferably, an ultrahigh dielectric and/or conductive silicone (e.g., as seen in FIG. 5) that retains adhesive properties may be achieved by the following process: [00127] (1) Define the percentage of the total silicone composition by volume of a deadener (e.g., Slacker®, (Smooth-On Inc., Macungie PA) a commercially available deadener preferably reduces the inherent biasing rebound properties of silicone or deadens silicone for encapsulations and provides silicone with a "flesh-like" feel) as "Z", ranging between about 20 to about 90%, then Silicone Base Part A = Silicone Base Part B = (100- Z)/2, where the silicone base is preferably Dragon Skin® 30 series (Smooth-On Inc., Macungie PA);

[00128] (2) Prepare about 40 to about 95 wt% of total rubber mixture comprising deadener and silicone base; 0 to about 5 wt% pyrogenic silica (e.g., HDK® provided by Wacker Chemie AG, Munchen Germany) and 0 to about 50 wt% carbonaceous or metallic conductive/nanomaterial additives;

[00129] (3) CNT and other nanomaterials are preferably not used at higher weight loadings than approximately 3 wt% without the use of additional platinum catalyst and heat curing (over 100 ° C), and are difficult to achieve full incorporation above 15 wt% of total rubber mixtures. Furthermore, incorporation of nanomaterials may be greatly enhanced by pre-mixing with pyrogenic silica, which forms a silica coating on the surface of the nanomaterials and breaks up homogenous interactions, while compatibilizing with silicone components;

[00130] (4) Resulting rubbers are preferably degassed, either at each stage (preferable for very viscous mixtures, for example, when MWCNT are used in high weight loadings) or in the final admixture (convenient for less viscous mixtures). Alternately, non-platinum cured silicone (e.g., 1 -part moisture curing elastomers) may also be used; and [00131] (5) Combine carbonaceous nanomaterial, blend with pyrogenic silica until evenly distributed, followed by mixing into the lowest viscosity component (preferably or typically the Deadener used); separately, mix the base silicone components (vinyl and hydride components with catalyst (e.g., Part A and Part B)), such that catalyst distribution is achieved and the cross-linking reaction begins. Combine the mixed Part A / Part B solution with loaded Deadener, mix thoroughly until even distribution, degas, and pour into a mould that has been coated with a release agent or onto a flat surface such that sheets are obtained for later use.

[00132] In some embodiments, the body 1 10 may preferably be embedded with photoluminescent additives such as, but not limited to, zinc sulfide, strontium aluminate, or any combination thereof. The photoluminescent additive may cause the device 100 to glow in the dark which may, for example, be used as a safety feature and/or for aesthetic purposes.

[00133] The device 100 may preferably have on board power storage using one or more power supplies 1 16 including, but not limited to, super capacitors, lithium polymer, nickel metal hydride, nickel cadmium, lithium, lithium ion, silver oxide, alkaline, or zinc batteries, or any combination or multiple thereof. This power storage may be charged and/or recharged by any method known to persons skilled in the art including, but not limited to, solar, differential temperature, motion, piezoelectric, inductive (i.e., wireless), contact, magnetic, and/or cable. Additionally, the charging method and/or power storage may preferably be flexible and/or located away from the line of flexation 1 18 (as depicted in FIGS. 3A and B). In some embodiments, the at least one sensor 64 may be configured as a charging contact.

[00134] The device 100 preferably measures a variety of data, including biological data 22 and nonbiological data 28 using the at least one sensor 64 and/or other components 1 14 (e.g., the strain gauge 65). The biological data 22 and/or nonbiological data 28 may preferably comprise skin conductance, electromyography, electrocardiograph, electroencephalography, respiration, galvanic skin sensing, gyroscopic or accelerometer, temperature, strain gauges, photoacoustic imaging, elastography, pulse oximetry, optical heart rate monitoring, force sensing, respiration, vibration, location and/or optical imaging. These different sensing methodologies can be achieved through one or more of the same sensors 64, wherein two or more measurements occur through some or all of the one or more sensors 64.

[00135] The strain gauge(s) 65 may preferably be mechanically coupled to an adherend, such as the skin (e.g., by integration into the pad 120). In some embodiments, the at least one sensor 64 (as shown in FIGS. 3A and B) may be formed in the shape of a strain gauge 65. The strain gauge(s) 65 may preferably be used to assess changes in muscle size, posture, blood volume, recovery, growth, and/or stress loads on structures (e.g., load-bearing supports). Alternatively, or in addition, the strain gauge(s) 65 may preferably correct for the elongation and/or flexation of the at least one sensor 64 (e.g., correcting for a change in the resistance if the sensor 64 is under strain). Strain gauge(s) 65 may preferably be adapted for placement in different orientations to assist in the differentiation of various muscle properties such as flexation, blood volume, and/or recovery. Further differentiation of various muscle properties may preferably be achieved by the combination of strain gauge information with other sensing methodologies measuring biological data 22 and/or accessory device data 24. As an example, optical sensing may preferably be used to determine blood volume and hydration and electromyography may preferably determine flexation thereby allowing the stain gauge(s) to determine muscle recovery and growth. In some embodiments, strain gauge(s) 65 applied to load-bearing supports may detect the development of, for example, cracks in a wall or bending of a beam.

[00136] In some embodiments, the device 100 may preferably have display, auditory, and/or tactile components embedded such as, but not limited to, LED, LCD, OLED, e-ink, VDF, seven segment displays, speakers, vibrators, shocking, cooling, heating, actuated pins, or any combination or multiple thereof. The tactile components may be positioned such that they are directed at the skin and/or project away from the skin and be read when passing a finger over a surface of the device 100.

[00137] In alternate embodiments of the device 100, the electrical substrate 1 12 may be a soft and/or flexible platinum cure silicone. The components 1 14 may be conventional rigid components, although some resistors may be replaced with semi-conductive ink such as carbon ink. The electrical connections may comprise conductive ink and may or may not be arranged in a waved pattern to allow for elongation. Such an embodiment may preferably allow for greater flexibility, softness, robustness, and/or shock resistance for the device 100. [00138] Processors [00139] Preferably, the processors 90 — i.e., the device processor(s) 90a and/or the parent processor(s) 90b— are operatively encoded with one or more algorithms 801a, 801b, 802a, 802b, 803a, 803b, 804a, 804b, 805a, 805b, 806a, 806b, 807a, 807b, 808a, 808b, 809a, 809b, 810a, 810b (shown schematically in FIG. 2 as being stored in the memory associated with the device subsystem 60 and/or the parent device subsystem 70) which provide the processors 90 with encryption logic 801a,b, location logic 802a,b, user data logic 803a,b, extrinsic data logic 804a,b, index data logic 805a,b, report generation logic 806a,b data packet generation logic 807a,b, filter application logic 808a,b, machine learning logic 809a,b, and population data logic 810a,b. Preferably, the algorithms 801a, 801b, 802a, 802b, 803a, 803b, 804a, 804b, 805a, 805b, 806a, 806b, 807a, 807b, 808a, 808b, 809a, 809b and/or 810a, 810b enable the processors 90 to assess the biological and nonbiological data 22, 28 received from the device processor 90a and/or the accessory device data 24 received from the accessory device processor 82 as well as any additional data that may be associated with the user 20 (for example, user data 26 which may be a combination of biological data 22, nonbiological data 28, accessory device data 24 and/or other data that may be provided by a user 20 or third party). The parent device processors 90b and/or the device processors 90a are also preferably operatively connected to one or more power sources 1 16.

[00140] The parent processor(s) 90b are preferably in communication with the device processor(s) 90a and/or the accessory device processor(s) 82. Preferably, the parent processor(s) 90b may be used to automatically: (i) collect the data associated with the user 20 (e.g., biological data 22 and/or nonbiological data 28); (ii) combine and/or reconcile the data associated with the user 20 (biological data 22 and/or nonbiological data 28 with accessory device data 24) and generate user data 26; and/or (iii) compare the user data 26 with population data 21 to generate a wellness status.

[00141] In accordance with the present invention, reconciliation is the combination of data 21 , 22, 24, 26, 28, 29, 30 to facilitate the generation of index data 27, reports 200 and/or wellness indicators. In some preferable embodiments, if all of the collected data is not required to determine the desired index data 27, report 200, and/or wellness indicator, then the reconciliation will only select the required collected data 21 , 22, 24, 26, 28, 29, 30 to determine the index data 27, report 200 and/or wellness indicator.

[00142] Population data 21 preferably comprises historical reference information of the biological data 22, accessory device data 24, user data 26, index data 27, nonbiological data 28, extrinsic data 29, and/or machine data 30 whether derived in accordance with the present invention or obtained from a third party database. In some preferable embodiments, population data 21 comprises data from the same user 20 (e.g., over time) or a plurality of users 20 (e.g., over a given amount of time). [00143] Preferably, the parent processor(s) 90b may generate the user data 26 during, after, or substantially contemporaneous with the receipt of biological data 22, nonbiological data 28 and/or accessory device data 24 associated with the user 20.

[001 4] Preferably, the device processor(s) 90a and/or the parent device processor(s) 90b automatically determine, at regular intervals, the user data 26. Some of the user data 26 may include biological data 22, nonbiological data 28, accessory device data 24 associated with the user 20 and the status of any communication link between the device processor(s) 90a, the accessory device processor(s) 82 and the parent device processor(s) 90b.

[00145] The user data 26 may be determined in a variety of ways, and a variety of user data 26 may be determined. In many cases, the user data 26 may be determined over a particular time interval, between different activities or two or more locations. The time interval, activities and/or locations may be determined by the user 20 and/or a third party as needed, or it may be a predetermined one.

[00146] The user data 26 may be compared with population data 21 - in particular, predetermined targets and/or preferences. For example, the user 20 may determine, prior to associating the device 100, that it will be preferable to achieve and/or maintain, for example, a target heart rate, blood pressure, or stress level (e.g., a combination of different biological signals). Preferably, the pre-determined targets for the user data 26 are stored in the parent database 71 , the remote database 83, and/or the device database 62 as population data 21.

[00147] In some preferable embodiments of the invention, however, the data 22, 24, 26, 28, 30 does not need to be compared with the population data 21.

[00148] Preferably, the device 100 may also be used as an audit device by comparing the user data 26 with the pre-determined targets for the user data 26.

[00149] The system 50 may also be useful in an athletic training or medical context in accordance with the present invention. [00150] Parent Database [00151] As may be best appreciated by a consideration of FIG. 1, the parent device database 71 is preferably within the parent device subsystem 70 and located remotely from the accessory device subsystem 80 and the device subsystem 60.

[00152] The parent database 71 includes, and is regularly updated with, the biological data 22, the nonbiological data 28, the accessory device data 24, the user data 26, extrinsic data 29, index data 27, machine data 30 and population data 21. The system 50 may include other databases, such as, for example, a device database 62 and/or remote database 83.

[00153] The databases 62,71 ,83 preferably include information associated with one or more users 20 such as the following information: heart rate ("HR"), heart rate variability ("HRV"), breathing rate ("BR"), stress, anxiety, sleep patterns, cognitive function, fatigue, emotional profile, and/or cardiac health.

[00154] All or part of the databases 62, 71 , 83 may be located behind a firewall relative to the communications network 300. Persons of ordinary skill in the art will appreciate that references herein to the parent database 71 , the device database 62 and/or the remote database 83 may include, as appropriate, references to: (i) a single database located at a facility (e.g., in association with a parent device subsystem 70); and/or (ii) one or more congruent and/or distributed databases 61 , 71 , 83 such as, for example, also including one or more sets of congruently inter-related databases 61 , 71 , 83 - possibly distributed across multiple facilities. [00155] The device processor(s) 90a and accessory device processor(s) 82 may or may not be otherwise adapted to (on their own) transmit the data to the parent processor(s) 90b and/or the parent database 71. The system 50 may store the data in the parent database 71 , the device database 62 and/or the remote database 83.

[00156] Data Packets

[00157] Preferably, the data 22, 24, 26, 28 are divided or disassembled into a plurality of manageable and discrete data packets prior to transmission by the processors 80, 90a, 90b using the data packet algorithm 807a,b. Following transmission, the plurality of discrete data packets are preferably automatically joined or reassembled into the corresponding data 22, 24, 26, 28 by the processors 90 using the data packet algorithm 807a,b.

[00158] The data packets may be data packets in the conventional sense, or they may be more akin to data "chunks". That is, the present invention contemplates the use of any suitable way of segmenting and transmitting the data 22, 24, 28 for subsequent re-assembly. For example, all data associated with a specific user 20 may be transmitted together. Any users 20 for which only a partial record is received, or any users for which no data and/or corrupted data is received may be flagged for correction, follow-up and/or replacement. It is implicit from all the foregoing that, when appropriate, data packets in the conventional sense may be suitable for incorporation in and/or use with the present invention.

[00159] Encryption

[00160] Preferably, the biological data 22, the nonbiological data 28, the accessory device data 24, and the user data 26 are encrypted or de-encrypted (or decrypted) for secured transmission by the processors 82, 90 using the encryption algorithm 801a, 801b. Following transmission, the encrypted data is preferably automatically de-encrypted by the processors 82, 90 using the encryption algorithm 801 a, 801b.

[00161] Communication Interruption

[00162] If the entire biological and/or nonbiological data 22, 28 has not been transmitted, the processed data 22, 28 is cut off and/or delineated and the data 22, 28 will remain open and/or considered un-transmitted.

[00163] Preferably, if the transmission of the data 22, 28 from the device processor(s) 90a is terminated, severed, interrupted and/or impaired - whether to the processors 90, the parent database 71 and/or the device database 62 - then the transmitted data 22, 28 that has been received by the parent database 71 and/or the parent processor(s) 90b may be deleted (from the device subsystem 60). Un-transmitted data 22, 28 that has not been received by the parent database 71 and/or the parent processor(s) 90b may be received by and maintained on the device database 62 for subsequent transfer to the parent database 71 and/or the parent processor(s) 90b when communication is restored. [00164] The device subsystem 60 may even replace the need for the accessory device processor(s) 82 to have any other communication link to the parent device subsystem 70. The biological data 22, the nonbiological data 28 and the accessory device data 24 may preferably both be transported by the device 100 to the parent database 71 and/or the parent processor(s) 90b. [00165] In some embodiments, the device processor(s) 90a and/or the parent processor(s) 90b may retrieve the accessory device data 24 from the accessory device processor(s) 82 substantially contemporaneously with, or at a different time than, the collection of the biological data 22 and/or the nonbiological data 28. Preferably the device processor(s) 90a and/or the parent processor(s) 90b may compare and/or combine the accessory device data 24 against the biological data 22 and/or the nonbiological data 28. The device processor(s) 90a and/or the parent processor(s) 90b may determine - preferably during, after and/or substantially contemporaneous with the accessory device data 24 collection process - if any conflicts between similar data 22, 24, 28 (e.g., heart rate). Any issues may preferably then be highlighted to the user 20 or a third party for remediation.

[00166] Location Information [00167] Preferably, the processors 90 may also be used to confirm and/or monitor the physical location of the user 20 and/or the position of the body of the user 20 in three- dimensional space. More specifically, using the location algorithm 802a,b, the processors 90 may be used to compare nonbiological data 28 comprising location information generated by the locator 63 to a target value set by the user 20 or third party. For example, latitude and/or longitude information residing in or retrieved by or from the device processor(s) 90a and/or from the locator 63 may preferably be translated into an address and/or compared against a target value set by the user 20 or third party to ensure consistency or to highlight any differences between the two (e.g., a user 20 may attempt to run a given distance and/or reach a target location in a predetermined amount of time). For example, body position information residing in or retrieved by or from the device processor(s) 90a and/or from the locator 63 may preferably be translated into a body pose of the user 20 and/or compared against a target value set by the user 20 or third party to ensure consistency or to highlight any differences between the two (e.g., during rehabilitation to regain range of motion, a user 20 may monitor current body position against a predetermined body position).

[00168] User Data [00169] Preferably, the processors 90 may also be used to collect, reconcile and/or analyze user data 26. More specifically, using the user data algorithm 803a,b, the processors 90 may be used to collect and reconcile the biological data 22, nonbiological data 28, and/or accessory device data 24.

[00170] Biological data 22 and accessory device data 24 may include: heart rate (HR), heart rate variability (HRV), breathing rate (BR), stress, anxiety, sleep patterns, cognitive function, emotional profile, cardiac health, gyroscopic or accelerometer information (e.g., direction and motion information of the user 20, acceleration of the user 20, and/or movement / acceleration of an appendage of the user 20 such as arm speed).

[00171] Nonbiological data 28 may include: location information comprising the physical location of the user 20 and body position of the user 20 in three dimensional space.

[00172] Preferably, using the population data algorithm 810a,b, the user data 26 collected by the processors 90 is compared to (i) one or more target values set by the user 20 or third party; and/or (ii) population data 21.

[00173] In some preferable embodiments, a combination of the biological data 22 and/or nonbiological data 28 comprising accelerometer information and gyroscope information may be used by the processors 90 to increase the accuracy of the direction and motion sensing determination of the user 20 when compared to the use of accelerometer information or gyroscopic information alone.

[00174] In alternate embodiments, more than one device 100 may be associated with a single user 20 to form a network to concurrently measure biological data 22 and/or nonbiological data 28 from additional muscles (e.g., to provide additional insight into form, fatigue, and/or systemic response), inanimate surfaces and/or structures.

[00175] The processors 90 collect, combine, reconcile and/or compare the foregoing data for presentation of, for example, a generated wellness status using the graphical user interface 72a or generation of an alert as described below. [00176] Presentation

[00177] The processors 82, 90 preferably generate a signal for presentation of the various data (such as, biological data 22, nonbiological data 28, accessory device data 24, user data 26, index data 27, extrinsic data 29 and/or machine data 30), in the form of wellness status for example, to the user 20 and/or a third party (e.g., an administrator) of the system 50. The data 21 , 22, 24, 26, 27, 28, 29, 30 may be presented by the system 50 using a graphical user interface ("GUI") associated with the device processor(s) 90a and/or the parent device processor(s) 90b. As shown in FIG. 1, the data 21 , 22, 24, 26, 27, 28, 29, 30 may be presented using one or more reports 200 or alternately a wellness indicator. The wellness indicator preferably represents the status of the user and includes, but is not limited to, an indication of stress, focus, meditation, fatigue, coherence, happiness, excitement, emotion, disease state (e.g., cardiovascular status). [00178] FIG. 2 schematically illustrates, among other things, various input/output devices 72 (including the GUI 72a, a printer 72b, speakers 72c, and LED emitting diodes 72d) associated with the parent database 71 , the device subsystem 60 and/or the parent device subsystem 70. [00179] The GUI 72a may include a touchscreen (and the two terms may be used interchangeably herein), a display with or without a "point-and-click" mouse or other input device. The GUI 72a enables (selective or automatic) display of the data 21 , 22, 24, 26, 27, 28, 29, 30 determined by the processors 82, 90 - whether received directly therefrom and/or retrieved from the databases 62, 71 , 83 ~ as well as display and input, of the certain target parameters and other information associated with the user 20.

[00180] The system 50 includes a report generation unit for generating the reports 200. Among others, the following reports 200 may be generated, based upon the population data 21 , the biological data 22, the nonbiological data 28, accessory device data 24, user data 26, index data 27, extrinsic data 29 and/or machine data 30: activity reports; medical reports; fitness reports; location reports; accessory device reports; user reports (including, for example, user direction and motion); structural reports; user customized reports; and/or communication reports. The reports 200, are alternately wellness indicators.

[00181] The GUI 72a may display the population data 21 , biological data 22, nonbiological data 28, accessory device data 24, user data 26, index data 27, extrinsic data 29, machine data 30 and/or various alerts. Such alerts may include visual, audible, or tactile warning signals which may be triggered to highlight a given condition to the user 20, for example, if an activity or health target (e.g., heart rate) is exceeded. [00182] FIG. 6 is a graphical representation of an interface which may preferably be presented by the GUI 72a. As shown in FIG. 6, the GUI 72a preferably presents, among other things, data associated with the user 20 (e.g., user data) including, an indication of focus 400, an indication of stress 402, and heart rate 404. Focus 400 and Stress 402 are preferably considered wellness indicators and are determined using the population data algorithm 810a,b based, in part, on the user data 26.

[00183] FIG. 7 is a graphical representation of an interface which may preferably be presented by the GUI 72a. As shown in FIG. 7, the GUI 72a preferably presents, among other things, an indication of time autonomous user states 406, an indication of the time stamped and contingent user states with associated normatives, suggestions, and questions 408. In preferable embodiments, the autonomous user states 406 and the contingent user states 408 are wellness indicators (e.g., an indication that the user is experiencing "high stress").

[00184] FIGS. 8A to 8D are graphical representations of an interface which may preferably be presented by the GUI 72a. FIGS. 8A and 8B depict the high and low frequencies associated with high coherence and a high coherence graph, respectively. FIG. 8A depicts a state of heart rate coherence for a user, defined as the synchronization of heart rate variability with respiration. This high coherence state is determined by the sinusoidal pattern of instantaneous heart rate as a function of time. FIG. 8B depicts a subject state of predominant high frequency heart rate variability. The balance of high to low frequency HRV is a surrogate measure of autonomic activation, with high frequency HRV associated with parasympathetic activation (i.e., a meditative state). FIGS. 8C and 8D depict the high and low frequencies associated with low coherence and a low coherence graph, respectively. FIG. 8D depicts a subject state of predominant low frequency heart rate variability, indicating greater contribution of the sympathetic nervous system (i.e., a stressed or active state). [00185] Targets and/or Preferences

[00186] The system data are preferably compared, using the processors 82, 90, against the population data 21 , including but not limited to, predetermined targets, target parameters and/or preferences for the biological data 22, nonbiological data 28, accessory device data 24, user data 26, index data 27, extrinsic data 29 and/or machine data 30. [00187] Alerts

[00188] If the biological data 22, nonbiological data 28, accessory device data 24, user data 26, index data 27, extrinsic data 29 and/or machine data 30 is outside of the target parameters, or other than preferred, the processors 82, 90 will generate an alert for presentation to the user 20 and/or a third party (e.g., an administrator). [00189] The processors 82, 90 may also be adapted to analyze the data 22, 24, 26, 27, 28, 29, 30 and alerts may preferably be sent from the device subsystem 60 and/or the parent device subsystem 70. In this manner, users 20 and/or third parties may preferably be alerted of any values for data 22, 24, 26, 27, 28, 29, 30 that are outside of their respective target parameters. [00190] FIG. 9 is a graphical representation of an interface which may preferably be presented by the GUI 72a . As shown in FIG. 9, the GUI 72a preferably presents, among other things, biological data 22 (e.g., heart rate) including an alert. Such an alert may include visual (tactile or audible) warning signals which may be triggered to highlight a given condition to the user 20, for example, if a target stress level is exceeded.

[00191] Method [00192] FIGS. 10A and 10B depict steps of a method 500 to reconcile data for use in association with the biological data 22 and/or the nonbiological data 28. Persons skilled in the art will understand that the populations data 21 , accessory device data 24, user data 26, index data 27, extrinsic data 29 and/or machine data 30 may be used in the method 500 and/or sub-method 600 in addition to, or in place of, the biological data 22 and/or the nonbiological data 28. In the description of the method 500 and sub-method 600 which follow, the same reference numerals are used as those which are used, above, with reference to the system 50 and the device 100. Method 500 is suitable for use with the system 50 and device 100 described above and shown in FIGS. 10A and B, but it is not so limited.

[00193] As shown in FIG. 10A, the method 500 includes the following steps, among others: a start step; a step 501 of entering targets for biological and/or nonbiological data into the databases; an association of device with a user step 502; a biological and/or nonbiological data reception step 504; a biological and/or nonbiological data collection step 506; a report generation step 508; and/or a step 510 of storing the biological and/or nonbiological data in the databases 62, 71. [00194] It will be appreciated that, according to the method 500, the biological data 22 and/or the nonbiological data 28 is collected by the device 100. The method 500 preferably involves the application of the device to the user 20. One or more components 1 14 (including a sensor 64) of the device 100 may collect biological and/or nonbiological signals associated with the user 20 that are preferably recorded as biological data 22 and/or nonbiological data 28 in the device database 62. The processors 90 are used to automatically: collect the data 22, 28; combine and/or reconcile the data 22, 28 against one another (e.g., accessory device data 24) to generate user data 26; compare the user data 26 against the population data 21 (e.g., historical reference information, and/or user data 26 of the same user 20 or a plurality of users 20), as applicable, and/or the target value(s) for the data 22, 28; and generate a report 200 which includes the collected, combined, reconciled and/or compared data 22, 28, preferably presented to the user 20 (or a third party) in the form of a wellness indicator. Thus, according to the invention, the method 500 operatively facilitates the analysis of, for example, wellness or health information of the user 20.

[00195] In preferable embodiments, the report 200 collected, combined, reconciled and/or compared data 22, 28 (including, as appropriate, the population data 21, the accessory device data 24, the user data 26, the index data 27, the extrinsic data 29, and the machine data 30), all or some of which may be presented to the user 20 (or a third party) in the form of a wellness indicator.

[00196] As shown in FIG. 10B, the sub-method 600 follows the biological and/or nonbiological data collection step 506 and includes the following steps, among others: a step 602 of determining the value of the desired biological and/or nonbiological data; a step 604 of querying if the biological and/or nonbiological data is outside of the predetermined target parameter for the data. In the event that the query is answered in the affirmative (i.e., if the biological and/or nonbiological data does not meet the predetermined target parameters), the subroutine 600 proceeds to an alert step 608 of alerting the user 20 and then to a step 610 of presenting it to the user 20. If answered in the negative, the sub-method 600 directly proceeds from step 602 to 610. If applicable, a step 609 of sending a signal to the device subsystem 60, the parent device subsystem 70, and/or the accessory device subsystem 80 may also be included in the subroutine 600.

[00197] The computer readable medium 130, shown in FIG. 2, stores executable instructions which, upon execution, analyzes data associated with a user 20. The executable instructions include processor instructions 801a, 801b, 802a, 802b, 803a, 803b, 806a, 806b, 807a, 807b, 808a, 808b, 809a, 809b, 810a, 810b for the processor(s) 90 to, according to the invention, perform the aforesaid method 500 and sub-method 600 and perform steps and provide functionality as otherwise described above and elsewhere herein. The processors 90 encoded by the computer readable medium 130 are such as to receive data (including population data 21 , biological data 22, nonbiological data 28, accessory device data 24, user data 26, index data 27, extrinsic data 29, and/or machine data 30), perform an analysis on the data 21, 22, 24, 26, 27, 28, 29, 30 generate a report 200 based on the analysis, and transit the data 21, 22, 24, 26, 27, 28, 29, 30 to the parent database 71, the device database 62 and/or the remote database 83. Thus, according to the invention, the computer readable medium 130 facilitates use of the processors 90 to operatively facilitate the analysis of health information of the user 20. [00198] Thus, the system 50, method 500, device 100, and computer readable medium 130 operative facilitate promoting the wellness or health of an individual (e.g., a single user 20) and population (e.g., a large number of users 20) scale.

[00199] Adhesive Topology [00200] In mechanical adhesive bonding theory, adhesion may occur via the adhesive filling in the micro-cavities of the adherend in a "lock and key" type manner. This mechanism may require at least one of the surfaces to have a micromorphology and an adhesive with a low viscosity to fill that morphology. For strong adhesion, it may be advantageous for the adhesive to wet the adherend. To facilitate thermodynamically favourable wetting, the surface tension of the adhesive should preferably be less than the critical surface tension of the adherend. The force of adhesion may increase with surface area. Therefore, a stronger adhesive bond of the mechanical component may be achieved with a higher surface area as may be disclosed in the present invention.

[00201] In some preferable embodiments, the reusable adhesive pad 120 and the body 1 10 of the present invention form an adherent single body. The adhesive pad 120, whether bonded with the body 1 10 or forming a single body, comprises at least one adherent surface 124. In preferable embodiments, the at least one adherent surface 124 comprises a texture (e.g., roughened, grooved, dimpled, undulating, etc.). In preferable embodiments, the texture may comprise topological features and/or patterns as best shown in FIGS. 12 to 15. As may be understood by persons of skill in the relevant art, a "single body" may generally refer to materials of different mechanical material properties sharing the same base chemical structure facilitating chemical and/or physical bonding (for example, but not limited to, a polyorganosiloxane polymer backbone) creating an intimate contiguous integration, preferably at an interface, between the material groups. The adhesive bond strength between the adhesive of the adherent surface 124 and adherend (e.g., skin of a user 20, an inanimate surface) may preferably be enhanced through the presence of the textures, as disclosed in greater detail below.

[00202] As depicted in FIGS. 12 to 15, the surface 124 of the adhesive pad 120 for contacting the adherend preferably comprises a texture or pattern to increase the surface area of the adherent surface 124 and improve adhesion to the adherend. The pad 120 is preferably soft, flexible, and/or reusable, and preferably comprises a sticky material (alternately an adhesive) that, in some embodiments, surrounds at least one sensor 64 on a side of the device 100. Other preferable embodiments of the device 100 do not include a sensor 64. The adherent surface 124 preferably comprises a level of stickiness that allows the pad 120 to adhere to a surface (e.g., skin, table, wall) with sufficient force such that no additional means (e.g., straps, hooks, velcro) are required for the pad 120 to adhere to the surface. The adherent surface 124 repels water (e.g., rain, sweat, etc.) so that the force of adhesion to the surface is preferably not moisture dependent.

[00203] As aforementioned, the adhesion characteristics of the pad 120 may be modified by varying the size, shape, density, protrusion and/or extrusion depth of the texture, topological features and/or patterns. More specifically, the texture, topological features and/or patterns may preferably present as a set of concentric contiguous features from the outer perimeter of the adherent surface 124 inwards and may provide added resistance to, for example, initial delamination at an edge of the single body. The concentric contiguous features advantageously act to increase the surface area of the pad 120 available to contact the adherend and physically acts as a seal to prevent the inwards transport of moisture and/or water.

[00204] Persons skilled in the art may understand that the macro-topology of the adherent surface 124 preferably stretches certain soft adherends (e.g., skin) to further enhance the surface area of the pad 120 available to contact the adherend. In addition, those skilled in the art may also understand that the micro-topology of the adherent surface 124 preferably penetrates cracks in the skin to seek out additional surface area. FIG. 11 depicts macro-topology and micro-topology as may be known in the prior art. [00205] FIG. 12 depicts macro-topology on the adherent surface 124 of the pad 120 that is preferably opposed to a direction of peel (of the device from the adherend) for greater direction and peel resistance.

[00206] FIG. 13A depicts concentric rings on the adherent surface 124 of the pad 120 that preferably forms a gasket that prevents the ingress of fluids (e.g., water) to an interface of the adherent surface 124 and the adherend. The presence of fluid at the interface may decrease the adhesive force between the surface 124 and the adherend.

[00207] FIG. 13B depicts microgaskets on the adherent surface 124 which preferably prevents the ingress of fluids (e.g., water) and preferably provides greater peel resistance of the device 100 from the adherend as there is no clear starting point to peel. [00208] FIG. 14 depicts gaskets or microgaskets defining wells 124a on the adherent surface 124, for example formed by drilling, to act as a reservoir for sweat to facilitate longer adhesion during, for example, intense physical activity.

[00209] FIG. 15 depicts a biomimetic coral pattern on the adherent surface 124. Volume match between adhesive and skin in interface zone such that the surface area between the skin and the interface zone is preferably maximized (assuming equal elastic modulus).

[00210] Combinatorial Analysis of Intrinsic and Extrinsic Data

[00211] In a preferred embodiment, the present invention is adapted to monitor and/or provide objective and data driven health analysis for both individual users 20 and large groups of users 20 or populations (e.g., communities, cities, countries, etc.).

[00212] As may be known to persons having ordinary skill in the art, physiological sensors 64 preferably monitor dynamics (e.g., body dynamics of a user 20, dynamics of inanimate objects and/or structures), alternately known as user data 26, in accordance with the placement and category of the desired signal acquisition. Depending on the type of data to be collected, the requirements for the accuracy of the sensor 64 diverges. In some embodiments, the analysis of user data 26 defines the acceptable limit of discernment of a physiological state of a user 20.

[00213] As aforesaid, recent advancements in the art have identified interactive circuits between neurological, neurophysiological, cardiological, and immunological systems, among others, which collectively connect a body so as to form one contiguous, communicative system. The extensional insight derived from the integration of user data 26 with algorithms reflective of intrinsic physiological circuits includes psychophysiology, defined as the interpretation of attitudes, behaviors, and emotional states of a user 20 from their biological measurements (i.e., user data 26). Parallel analyses preferably derives indicators of cardiac health, all-cause mortality, and immunological challenge.

[00214] Also, as aforesaid, the simultaneous emergence of Internet derived meta-data and intelligent-data for capturing population level information on attitudes, behavior, and health, has reinvigorated short-term and long-term monitoring of various population trends in relation to local, regional, and global occurrences. [00215] In preferred embodiments of the present invention, the user data 26 (including the biological data 22, the nonbiological data 28 and the accessory device data 24) is combined and/or reconciled with extrinsic data 29 (that is data associated with an event, including, but not limited to Internet use patterns and behaviors to identify, derive and locate trends within and between population level attitudes, behaviors, and health). The reconciled combination of the user data 26 and the extrinsic data 29 is preferably compared to population data 21 corresponding to the user data 26 to generate index data 27. In some preferable embodiments, however, the reconciled combination of the user data 26 and the extrinsic data 29 is not compared to the population data 21. User data 26 (alternately referred to as intrinsic data 26), preferably includes heart rate (HR), heart rate variability (HRV), breathing rate (BR), stress, anxiety, sleep patterns, focus, cognitive function, emotional profile, cardiac health, and/or stress loads on structures. Persons of skill in the art may appreciate that the user data 26 may be associated with mortality, physical activity, signature movement recognition of infectious disease, and/or stress loads on load bearing structures, derived from the devices 100 capturing biologic information including, but not limited to, ECG, phonocardiogram ("PCG"), temperature, movement, HR, HRV, respiration, activity, posture and/or stress information. Internet use patterns and behaviors, hereinafter defined as extrinsic data 29, includes search engine activity, websites most frequented, social networking activity, social media and media trends, and time online. Non-internet derived climatic, economic, and demographic data is also preferably cross- referenced or associated with extrinsic data 29. Data that is internet derived or non-internet derived is preferably considered data from an event. [00216] As shown in FIGS. 16A and 16B, in preferable embodiments, intrinsic data 26 may be individualized, or randomized and anonymous, and can be referenced to the individual behaviors of the monitored user 20, or to a population (e.g., comprising a larger number of users 20) of interest. In preferable embodiments, extrinsic data 29 can pertain to the behaviors of the monitored user 20 or can be abstracted to a population to which the monitored user 20 belongs.

[00217] Teleological referencing can preferably determine the attitudes, preferences, behaviors, and health of the monitored user 20, either personalized, randomized, or on a population level in relation to extrinsic data 29.

[00218] FIG. 17 depicts steps of a method 700 to analyze the intrinsic data 26 and the extrinsic data 29 to preferably determine the index data 27. Persons skilled in the art will understand that the intrinsic data 26 — including but not limited to cardiac information, muscle information, skin temperature, posture, respiration, movement, location, neurological, serological, epigenetic and/or data derived therefrom— monitored by sensors 64 provided by, for example, the device 100 or accessory devices 81 (which may include implantable devices) are preferably used in the method 700. In the description of the method 700, the same reference numerals are used as those which are used, above, with reference to the system 50 and the device 100. Method 700 is suitable for use with the system 50 and device 100 described above and shown in FIG. 17, but it is not so limited.

[00219] As shown in FIG. 17, the method 700 includes the following steps, among others: a start step; a step 701 of defining a class of users 20 for monitoring (e.g., by creating geofences to define a geographic demographic, by categorizing users based on income, etc.); an intrinsic data collection step 702a; an extrinsic data collection step 702b; a data analysis and an index data generation step 703; a report generation step 704; and/or a step 705 of storing the intrinsic data, the extrinsic data, and/or the index data in the databases 62, 71, 83. The data analysis step 703 preferably comprises combining, reconciling, and/or comparing the intrinsic data 26 and the extrinsic data 29. [00220] It will be appreciated that, according to the method 700, the processors 90a,b (including remote or cloud-based processors) preferably analyze the intrinsic data 26 by internet enabled computer applications, such as the user data algorithm 803a,b, to derive the one or more interactive circuits between the neurological, neurophysiological, cardiological, and immunological systems of users 20. Preferably, referential interrogation of the biologic systems - using the user data 26 - determines the attitudes, behaviors, and health of monitored users 20 via real time correlative mapping. Long-term and short-term attitudinal, behavioral, and health analyses of large numbers of users 20 (e.g., populations) are preferably estimated by monitoring and/or analyzing Internet activity or use patterns, behaviours, social media, search engine data, and/or internet survey data, as well as relevant economic, political, and climatic information (or circumstances) - the extrinsic data 29 - using the processors 90 and the extrinsic data algorithm 804a,b. In preferable embodiments, the processors 90 are configured to associate the intrinsic data 26 (i.e., individualized, defined by profile identity tagging, or anonymous and randomized, defined as randomly sampled in according to relevant population demographics) with extrinsic data 29 (i.e., preferably derived from automated crawling, scraping, harvesting, and web data extraction, as well as through API's provided by social media and media companies - e.g., Facebook®, Twitter®, New York Times®, etc. - using intended search parameters) using the index data algorithm 805a,b to generate the index data 27. In preferable embodiments, the index data 27 bidirectionally maps attitudes, behaviors, and health of individual users 20 and/or a large number of users 20 (e.g., in populations) in relation to a particular event (e.g., a disease outbreak, a new governmental policy, etc.). [00221] FIG. 18 depicts a system 50 mediated physiological analysis. Intrinsic data 26 is preferably collected, such as by using one or more devices 100, accessory devices 81, or other third party sources (e.g., third party databases) and analyzed by the processors 90 using the user data algorithm 803a,b. In some preferable embodiments, the algorithm 803a,b is derived using heuristics, machine learning models, and/or time frequency analysis to generate surrogate metrics for complex physio- and psychophysiological states, such as stress, focus, sleep, immunity, cardiac health, and/or respiratory health. [00222] FIG. 19 depicts a schematic of intrinsic data 26, preferably psychophysiological states, for analysis by the processors 90 using the index data algorithm 805a,b to determine the relative contribution of multivariate states (including, but not limited to, sex, activity, resting heart rate, mindfulness, sedentarianism, fear / anxiety / stress, sleep, and aggression) to overall well-being.

[00223] The invention preferably includes, but is not limited to, the following applications: (a) personalized preference based platform optimization achieved by combinatorial analysis of individualized intrinsic data 26 with entertainment platforms; (b) population health tracking as a function of climate by combinatorial analysis of local, regional, and global climatic data with demographically, representationally randomized intrinsic data 26; (c) enabling policy makers in a particular country to measure how its population is responding to various policy initiatives (e.g., Does the stress level of the population rise with increased taxes? Does the population have more difficulty sleeping with increased taxes?); and (d) preferably using the index data 27 to develop an international index similar to, for example, gross domestic product per capita or the human development index, that preferably uses the combination of intrinsic data 26 and extrinsic data 29 to provide a measure of the health or state of a given society and/or country (e.g., An announcement of new job creation could cause an indicator of the index data 27 to change).

[00224] In accordance with a preferred embodiment, the users can be identity tagged, anonymous, or identified randomly. In addition, index data from discrete populations may be defined and compared or cross-referenced. In an alternate preferable embodiment, the index data 27, intrinsic data 26 and/or extrinsic data 29 are stored in a remote database (e.g., cloud-based database). The data 26, 27, 29 is also preferably security encrypted by any means known to persons of skill in the art. In a preferred embodiment, the present invention facilitates the tracking of one or more of: disease prevalence and spread; political orientation; cultural attitudes; economic outcomes; climatic impact; population health; and purchasing behaviors. In addition, a preferred embodiment of the invention facilitates internet search engine performance optimization. Preferably, the intrinsic data 26 is temporally and geographically tagged and/or tracked by the system 50. A preferred embodiment of the present invention optimizes personalized preference based platform performance, evaluates online marketing efficacy, and monitors population level health interventions.

[00225] Integration of Hardware into Silicone Body

[00226] The present invention preferably applies design features to improve the integration of electronic components 1 14 into the body 110. In preferable embodiments, the body 1 10 comprises silicone. [00227] Enhanced integration between the components 1 14 and the body 110 is preferably achieved by including one or more perforations 113 into the components 1 14 to be embedded in the body 1 10. This design feature allows the body 1 10 to fill in the one or more perforations and once the body 110 cures (i.e., following the moulding process), the device 100 is more robust and durable. Delamination between, or separation of, the components 1 14 and the body 1 10 is advantageously greatly reduced. The one or more perforations can be of any shape, size, pattern, or density. Preferably, the perforations are circular to maximize the area of interaction between the body 1 10 and the components 1 14. Persons skilled in the art, however, will understand that alternative or custom shapes for the perforations can also be used with the components 1 14 to integrate the components 1 14 and the body 1 10. In some preferable embodiments, multiple shapes, sizes, and densities for the perforations can be included into a single component 1 14 to be embedded. Preferably, the smallest dimension (e.g., a radius of a circle, width / length of rectangle) for a perforation is about equal to or greater than 0.5 mm to facilitate wetting / filling by viscous elastomers that cure to form the body 1 10. The upper size limit of the perforation is preferably only limited by the size of the device 100 and/or circuit board 112. The perforations are preferably spaced by about 1 -2 mm. The percent surface area for the perforations is preferably only limited by structural integrity of the device 100 and/or circuit board 1 12 and allowing the device 100 to contain all of the desired components 1 14. The degree of integration between the body 1 10 and the components 1 14 increases as the total area provided by the perforations increases. However, the components 1 14 are preferably designed to accommodate the perforations, retain functionality and handle additional design constraints. FIG. 20 depicts a printed circuit board ("PCB") layout showing the inclusion of a series of 1 mm and 2 mm perforations 1 13. In preferable embodiments, the perforations are interspersed throughout the components 1 14 to minimize delamination. FIG. 21 A depicts a plan view of a device 100 comprising a body 110 embedded with a printed circuit board 1 12 connected to components 1 14, the printed circuit board 1 12 defining a plurality of perforations 1 13 proximal to the perimeter of the board 1 12. FIG. 21B depicts the device 100 of FIG. 21 A with the board 1 12 defining perforations 1 13 distal to the perimeter of the board 1 12. FIG. 21C depicts the device 100 of FIG. 21A with the printed circuit board 1 12, along with the associated components 1 14, surrounded by a protective casing 1 19 (e.g., potting compound, low pressure over mould, protective plastic case) in accordance with the present invention. FIG. 21D depicts the device of FIG. 21C with a sensor 64, preferably piezoelectric, projecting from the protective casing 1 19. FIG. 2 IE shows a side view of the device of FIG. 21A. FIG. 21F shows a side view of the device of FIG. 21D. [00228] The components 1 14 are preferably soldered to the circuit boards 1 12 to form an electrical connection for the operations of the device 100. In addition to enabling the components 1 14 to draw current, the points of solder also act as a physical bond between a given component 1 14 and the printed circuit board 112. In stationary circuits that are not subject to shock, rough handling or rapid acceleration, these solder points are often sufficient to maintain the mechanical and electrical connections required for continued operation. On the other hand, devices 100 subjected to the aforementioned conditions may necessitate additional protection and anchorage.

[00229] Conformal coatings, or potting compounds, (i.e., soft, cured elastomers that provide stress relief against applied stress and acceleration forces) preferably include epoxies, silicones, and urethanes among others. The conformal coating compounds preferably have high adhesion force and generally excellent wetting properties, and therefore also reinforce the bonding of individual components 114 to the circuit board 1 12. Single components 1 14 or the entire circuit board 1 12 may be conformably coated, depending on the prevalence of stress forces; furthermore, components 1 14 subject to high thermal loads can be coated with thermally conductive coatings to reduce failure from overheating. [00230] In cases of frequent and often rough handling, an additional measure of protection can be achieved by overmoulding components 1 14 with a full coating of rigid plastic either in conjunction with or instead of a conformal coating. Persons skilled in the art may understand this technique as low-pressure overmoulding ("LPO"). LPO is similar to injection moulding, wherein a thermoplastic is injected at high temperature and pressure to precisely reproduce a moulded shape. LPO is a related process wherein components 1 14 and/or circuit boards 1 12 to be protected are held within a mould, and surrounded by heated, pressurized liquid plastic; however, the injection process in LPO requires temperatures and pressures that will not destroy the components 1 14 they are intended to protect, therefore both of these metrics are lower in LPO than those of injection moulding.

[00231] Wearable devices 100 may be constantly subject to forces of acceleration, and stresses which may distort an unprotected printed circuit board 1 12. In this case, a combined strategy of using both conformal coatings (to reduce acceleration-induced detachment) and fully-encapsulating LPO (to protect from impact, shock, etc.) preferably improves operating lifetime of the device 100.

[00232] Another circuitry design feature that preferably improves integration of the body 1 10 and the circuit board 1 12 is to provide an outer edge of the board 1 12 with a tertiary structure. For example, instead of a straight line or arc (e.g., a rectangular board or a circular board), the edge of the board 1 12 can be patterned to increase the surface area of the board 1 12 and mechanically reinforce the integration between the board 1 12 and the body 1 10. [00233] Preferably, an edge of the printed circuit board 1 12 is cut at angles other than 90 degrees. For example, the edge can be chamfered or filleted to increase the contact area (e.g., volume of silicone) at the interface between the components 114 and the body 1 10. In preferable embodiments, on a cross-sectional view, the edge has a radius equal to half the thickness of the components 1 14 to be embedded to reduce stress concentrations at the material interface the greatest.

[00234] Additional Sensing Modalities

[00235] The device 100 may also preferably include a vibration component 91 adapted to produce haptic feedback and vibration to provide alerts to the user 20. The vibration generator 91 preferably comprises an inertial haptic actuator including eccentric rotating mass, a linear resonant actuator, or a piezoelectric "high definition" haptic actuator. The vibration generator 91 in contact with an adherend (e.g., the skin of a user 20) preferably provides a number of advantages. For example, different vibration patterns preferably provides a signal for different events. [00236] In some preferable embodiments, the device 100 may also include a heating component 92 for providing, for example, localized heat therapy or another means of feedback to the user 20.

[00237] Preferable embodiments of the device 100 include a sensor 64 adapted to collect vibrations from the adjacent body 1 10. Preferably, sensors 64 configured to detect vibrations comprise any vibration or pressure detecting component known to persons of skill in the art, such as a transducer or piezoelectric-based sensor embedded inside the body 1 10 (preferably composed of silicone) and operatively connected to the board 1 12 by a terminal 64b. Piezo sensors preferably comprise inflexible piezos (e.g., ceramic transducers) or flexible piezos (e.g., thin-film piezos) 64d (as shown in FIGS. 22A-C). As shown in FIG. 22 A, the piezo sensor 64 may preferably comprise a laminate 64c to provide support for the thin-film piezo 64d and the laminate 64c may further define throughholes 64d to maintain the position of the sensor 64 in the body 110. In some preferable embodiments, the piezoelectric is further customized by varying an associated mass to adjust the range of frequencies the sensor 64 can detect. FIGS. 22B and 22C depict a mass 64f associated with the sensor 64. Advantageously, the sensor 64 does not have to directly contact the user 20 and can be completely encased in the body 1 10. In a preferable embodiment, a device 100 comprising a sensor 64 for vibration detection and positioned onto the sternum or left rib cage of a user 20 can detect a biological data 22 such as phonocardiograph and breathing. In an alternate preferable embodiment, a device 100 comprising both a sensor 64 for vibration detection and an accelerometer 68 (e.g., 3-axis/6-axis/9-axis) allows for simultaneous acquisition of breathing, seismocardiogram that detects vibrations generated by the mechanical contraction of the heart (infrasonic, which is less than 25 Hz), and phonocardiography that captures heart sounds generated primarily by the sound of blood flow (i.e., audible frequency). In addition, using nonbiological data 28 (e.g., location information) preferably allows for a determination of when a stable phonocardiograph measurement of a user 20 can be most reliably recorded (e.g., no movement means that the user 20 is not walking around or laying in supine position, which will eliminate noise and improve the signal-to-noise ratio of the biological data 22). Preferably, the accelerometer 68 is configured to facilitate tracking of the posture of the user 20 including whether the user 20 is laying on their back, their side, or if they are slouching; and, in some preferable embodiments, may be a sensor 64.

[00238] In preferable embodiments, sensors 64 are modified to achieve the desired sensitivity for a specific application. For example, characteristics of piezoelectric sensors can preferably be varied, including resonant frequencies, shapes, and masses (as aforesaid). In addition, configuration design factors that affect the sensitivity of the piezoelectric sensor can preferably be tailored depending on a specific sensing application. For example, the sensitivity of the flexible piezoelectric sensor embedded in the body 1 10 can preferably be improved by fixing or anchoring the piezoelectric onto a solid or rigid part of a component 1 14, including a printed circuit board 1 12, having a mass greater than the piezoelectric sensor (see, for example, FIGS. 23A and 23B) compared to having the piezoelectric sensor not affixed to a solid or rigid part of a component 1 14 (see, for example, FIG. 24 A). Depending on the sensing applications, however, other configurations of the piezoelectric sensor may be preferred (FIG. 24B, for example, where the piezoelectric sensor 64 is beneath the printed circuit board 112). For detection of biological data 22 comprising heart beats, a cantilever beam configuration is preferred, as depicted in FIGS. 23A and 23B. Such a configuration increases the sensitivity of the piezoelectric by enhancing the electromechanical coupling. The position of the piezoelectric within the body 110 is preferably defined by the following variables, as depicted in FIGS. 25A - 25C: length (L T ); width (Lw); shape (e.g., rectangular, rounded, etc.); height (L h ); extended length from an edge of the board 1 12 to the end of the sensor 64 (LE); distance from the end of the piezoelectric to the edge of the body 1 10 (d); length of the terminal 64b (L term ); thickness of the body 1 10 above the piezoelectric (TA); thickness of the body 110 below the piezoelectric (TB); thickness of the body 1 10 below the piezoelectric and above the adhesive layer 120 (TBI); and/or thickness of the adhesive silicone layer (TAd)- In addition, persons of skill in the art will understand that the mechanical properties of the body 1 10 can preferably be altered to adjust the sensitivity of the piezoelectric sensor. [00239] For collecting certain biological data 22 (i.e., heart rate), a device 100 is preferably positioned below the sternum of a user 20. A sensor 64 comprising a piezoelectric, embedded in the body 1 10, is preferably positioned within the following parameters: thickness of silicone below piezoelectric is about 0.5 to about 4.0 mm and preferably about 1.5 to about 2.0 mm; thickness of silicone above piezoelectric is about 0.5 mm to about 5 mm and preferably about 1 mm to about 3 mm; length of extension from edge of printed circuit board is about 1 mm to about 20 mm and preferably about 10 mm to about 15 mm; the distance from the end of the piezoelectric to the edge of the silicone device is about 1 mm to about 30 mm and preferably about 2 mm to about 10 mm; and the durometer value of the body is less than Medium Soft shore 80A and more preferably less than a soft shore Durometer of 3 OA.

[00240] In some preferable embodiments, a piezoelectric provided by Murata Electronics 7BB-20-6 (resonate frequency of about 6.3 kHz), and more preferably Minisense 100 with mass and a resonant frequency of about 80 Hz have preferred sensitivity. A preferred piezoelectric LDT0-028K from Measurement Specialties (with no mass) and preferably having a sensitivity of about 50 mV/g and resonant frequency - about 180 Hz, and about 3 db frequency for resonance - about 90 Hz, with no masses to allow for an overall thinner profile (total silicone height above and below piezoelectric). The addition of masses preferably decreases resonant frequency while increasing sensitivity. Preferably, the filter application 808a,b can provide a good signal without the need for masses to detect a heartbeat when placed just beneath the sternum of a user 20.

[00241] The inclusion of one or more sensors 64 for vibration detection (i.e., to capture biological data 22 such as phonocardiograph measurements) and for electrocardiograph sensory allows for the continuous measurement of the blood pressure of the user 20.

[00242] As may be known to persons skilled in the art, the combination of components 1 14 with a device 100 such that a single component 1 14 preferably has more than one sensing and/or feedback modalities (e.g., 3-axis, 6-axis, 9-axis, inertial mass unit, 12-axis; sensors 64; heating component 92; vibration generator 93, input-output component 66, temperature, barometer and ambient light, etc.) may be advantageous depending on the desired application for the device 100.

[00243] In some preferable embodiments, the device 100 may comprise one or more components 1 14 adapted to function as (i) an accelerometer 68, such as a 3-axis accelerometer to detect no movement or the attainment of a predefined goal, and (ii) a vibration generator 91 to generate a vibration to alert the user 20 that the goal has been achieved.

[00244] In some other preferable embodiments, the device 100 may comprise one or more components 1 14 adapted to function as (i) an accelerometer 68, such as a 3-axis accelerometer to determine a type and intensity of movement of the user 20, and (ii) a sensor 64 (e.g., for sensing electrocardiogram or vibration for phonocardiogram) to demonstrate the effect of activity on the heart rate of the user 20.

[00245] In other preferable embodiments, the device 100 comprises one or more components 1 14 adapted to function as (i) a gyroscope 67 to determine the posture of the user 20, (ii) a vibration generator 91 to provide haptic feedback, and/or (iii) a sensor 64 for monitoring heart rate (e.g., for virtual reality applications). As shown in FIG. 26, posture or position dependent shape and form of the body of a user 20, is preferably determined using multiple devices 100 attached to, for example, a desired appendage (e.g., arm). Preferably, the device 100 may be shaped to conform with the contours of the body for the intended application. The devices 100 preferably comprise components (not shown) to measure the position and/or posture of the body, including a sensor, an accelerometer, a gyroscope, and/or a magnetometer.

[00246] FIG. 27 depicts a plurality of devices 100 positioned on a user 20, wearing a headset 18, for virtual reality bipolar feedback. Preferably, the device 100 positioned on the chest of the user 20 comprises a sensor 64 (not shown) configured to detect biological data 22 (e.g., heart rate and/or heart rate variability). Preferably, the devices 100 positioned on the appendages of the user 20 comprise an accelerometer 68, a vibration generator 91 (for haptic feedback) and/or a gyroscope 67. The aforementioned configuration is preferably adapted to monitor the physiological state and movement of the user 20 for interfacing with a virtual reality environment.

[00247] Preferably, for virtual reality applications, the single or multiple user experience is impacted by intrinsic data 22 of each user 20. As shown in FIG. 28A, the system 50 can preferably be configured to facilitate a virtual reality application for a single user 20 by varying the virtual reality experience for the user 20 based on the intrinsic data 22 collected by the multiple devices 100. As shown in FIG. 28B, the system 50 can preferably be configured to facilitate a virtual reality application for multiple users 20a, 20b, 20c, 20d by varying the virtual reality experience for the users 20a, 20b, 20c, 20d based on the intrinsic data 22 collected by the multiple devices 100 on each user 20a, 20b, 20c, 20d.

[00248] Persons skilled in the art will also understand that multiple devices 100 may be positioned over multiple locations on a user 20, for example, poor body form or position (e.g., shakiness or asymmetrical movement) and may also be adapted to alert the user 20 or third party to such poor body form or position.

[00249] Persons skilled in the art will also understand that multiple devices 100 may be positioned over multiple locations on an inanimate surface, for example, a table or wall to provide nonbiological data 28.

[00250] Adhesive Formulation [00251] The present invention further discloses a device 100 comprising at least one adherent surface 124, that is preferably pressure-sensitive. In preferable embodiments, the adherent surface 124 comprises topographical features and/or patterns. Preferably, the device 100 comprises one or more surfaces and/or facets that are not adhesive. In preferable embodiments, the adherent single body is a soft rubber material comprising a collection of materials of similar mechanical and/or chemical properties as aforesaid (e.g., exact chemical identity / chemical functional groups of separate components), sharing the same family of basic chemical structures (e.g., polysiloxanes, or more preferably those that are cross-linked via the hydrosilylation reaction in the case of platinum-cure silicones disclosed above), that facilitates chemical and/or physical bonding with the components 114, thereby creating an intimate contiguous integration between the single body and the components 1 14 therein. The chemical identities and chemophysicomechanical properties of the adherent surface 124 preferably promotes the adhesion of the device 100 to an adherend through solely secondary attractive forces.

[00252] In addition to secondary attractive forces, the bond strength between the pressure-sensitive adherent surface 124 of the single body and an adherend (e.g., the epidermis of biological organisms, or outer surfaces of inanimate objects) is preferably enhanced through the presence of topographical features, as aforesaid. Adhesion characteristics can be modified by varying the size, shape, density, protrusion/extrusion depth of topographical features. More specifically, topographical features present as a set of concentric contiguous features from the outer perimeter of the pressure-sensitive adherent surface 124 inwards preferably provides additional resistance to delamination at an edge of the pressure-sensitive adhesive surface 124, especially when acting to increase the surface area of the adherent surface 124 and therefore overall adhesive force with the adherend.

[00253] In view of the foregoing, the preferable composition of the adhesive applied to the adherent surface 124 is provided below. [00254] In preferable embodiments, the mix ratio and individual components of the soft rubber material (e.g., silicone) comprising the single body provide final properties such that neither the adherent surface(s) 124 nor the non-adherent surface(s) absorb a significant volume of oils or other contaminants from the skin (e.g., fatty acids, skin cells, etc.), water or other contaminants from sweat (e.g. salts or ions of sodium, potassium, magnesium, iron, urea, lactate, etc.). In embodiments of the device 100 comprising silicone, the repulsion of water is particularly important as silicon-oxygen bonds are susceptible to hydrolysis. In other words, the uptake of contaminants from the skin may result in the breaking of bonds and/or disruption of self-contiguity of silicone. Advantageously, due to the resistance of the adherent surface 124 to contaminant uptake, neither the permanent chemophysicomechanical structure nor overall adhesive behaviour of the silicone become significantly disrupted as a result of the repeated adherence to and removal of the single body from the skin. This preferably provides for long-term repeated use without a significant decrease in adhesive efficacy.

[00255] In preferable embodiments, the body (e.g., silicone) maintains its contiguous form throughout use, and during adhesion to the user 20, no primary forces (e.g., chemical bonds) are formed with the adherend (or substrate) such that the adhesive surface 124 or body is destroyed and/or weakened in whole or in part from the process of repeated application, adhesion and/or removal. In other words, no significant portion of the adhesive or material from the adhesive surface 124 is stripped away from the body during a given or repeated application to, and removal from, an adherend. However, persons skilled in the art, will understand that the silicone material is not, due to its soft nature, completely impervious to mechanical stress and fatigue over time, in the same way as cracks propagate over time in rigid materials due to repeated stress. [00256] In accordance with the present invention, the pressure-sensitive adherent surface 124 of the single body preferably minimizes or completely avoids damage to the skin of a user 20 and its associated structures (e.g., hair removal, hair follicle damage), while exerting adhesive forces of sufficient strength to remain affixed to the outer epidermis. Persons skilled in the art may appreciate that the rates of transepidermal water loss increase in proportion to the level of skin damage (i.e., the corneocyte cell layer (stratum corneum) can absorb three times its weight in water but if its water content drops below 10% it no longer remains pliable and cracks); and that in hot conditions, the secretion so sebum emulsify sweat produced by the eccrine glands, which produces a sheet of mixed (i.e., skin oil / sweat) that is not readily lost in drops of sweat. As may be known to persons of skilled in the art, for soft skin adhesives, the surface energy of the adhesive is preferably below the surface energy of the skin (i.e., -20-30 mJ cm -2 , with an average of approximately 25 mJ cm , depending on conditions such as dryness, age of skin, etc.).

[00257] The adhesive is preferably non-immunogenic and adheres to biological substrates (e.g., skin) for extended periods of time without irritation. However, persons of skill in the art may appreciate that near-permanent application could prevent the natural excretion of oil which may result in dermatological distress and is not the expressly intended mode of use.

[00258] The adhesive is preferably reusable and the adhesive force of the adhesive preferably ensures adherence of the single body to the skin without forming permanent or semi-permanent chemical bonds. Instead, the adhesive forces are preferably the sum total of non-covalent secondary attractive forces that exists between the adherent surface 124 and the skin. Preferably, the lack of covalent attractive forces allows the adhesive to be highly robust (i.e., mechanically durable or not physically ripping or tearing apart under specified use conditions).

[00259] In preferable embodiments, the adhesive may also covalently bind to and protect encapsulated or embedded components 114. The encapsulated components 114 and device circuit board or circuit substrate 112 have preferably been primed, but not necessarily, with commercially available short-chain silanols (e.g., Smooth-On Solaris bonding primer). The components 1 14 are preferably bound chemically to the curing silicone adhesive, followed by the curing silicone body. These steps combined, overall, form the permanently chemically bonded, contiguous silicone body 1 10. The body 1 10 preferably has a similar mechanical stiffness to the skin. The foregoing is described in greater detail below.

[00260] Skin-compatible topography/properties

[00261] In preferable embodiments, the chemophysicomechanical properties of the pressure-sensitive adherent surface 124 are such that it is soft enough to conform to the natural skin topography both on a macro-scale (e.g., the curvature of a muscle or the ribs), and on a micro-scale (e.g., within the epidermal valleys) to maximize the secondary attractive forces. Accordingly, the chemophysicomechanical properties of the pressure- sensitive adherent surface 124 is configured to "wet," and thereby complement, the natural epidermal texture. [00262] Preferably, a permanent topographical pattern of the pressure-sensitive adherent surface 124 maximizes surface area by stretching the skin to complement the pattern, or combination of patterns, of the adherent surface 124 which simultaneously applies forces that resist peel directionally, dependent on the pattern(s) - in other words, the skin is being stretched by macro-scale features of the skin (e.g., deformations around the undulations or features of the skin). This feature may be observed on the skin when an attached device 100 is removed, as the pattern of the adherent surface 124 leaves light red marks where the skin has been stretched/deformed.

[00263] Preferable examples of topographical patterns include a series or cluster of lines with an outwardly rounded profile and a closely-packed array of outward-facing hemispheres. Either one of these features may be varied in size from about 0.01 to about 2.0 mm on average at the greatest dimension, or preferably about 0.25 to about 0.5 mm.

[00264] In preferable embodiments, the patterns are applied to the pressure-sensitive adherent surface 124 by utilizing a mould with the desired texture during the manufacture or curing of the adherent surface 124.

Example 1

Components of an RTV silicone mixture to prepare a single-body with a pressure- sensitive adherent surface

[00265] A room temperature vulcanization ("RTV") silicone mixture was prepared to form a single body comprising a pressure-sensitive adherent surface 124. The mixture comprised: [00266] (i) a mixture of base silicone and platinum catalyst ("Part A");

[00267] (ii) a mixture of base silicone and hydride-containing silicone cross-linker ("Part B ); [00268] (iii) a cross-linkable silicone fluid (i.e., a deadener); and

[00269] (iv) additives (e.g., pyrogenic silica, carbon black, graphite, carbon nanotubes, silver nanowires, etc.).

Example 2

Process for making the device using an open air cure

[00270] The silicone base (Part A), cross-linker (Part B), catalyst, additives and a deadener were combined to form a fully cross-linked, cured rubber of appropriate proportions to obtain the desired reusable adhesive properties. The mixture was then placed in a vacuum chamber to remove the trapped air bubbles. Depending on the desired application, the ratio of base (Part A), deadener, cross-linker (Part B), and additives to silicone may vary.

[00271] FIG. 29 depicts steps of a method 900 for making the device 100 using an open air cure. In the description of the method 900, the same reference numerals are used as those which are used, above, with reference to the device 100 described above and shown in FIG. 29, but it is not so limited.

[00272] As shown in FIG. 29, the method 900 includes the following steps, among others: a step 901 of providing a mould 14 defining a mould cavity 15; a step 902 of applying a first elastomer layer 140 to the mould cavity 15; a step 903 of applying a second elastomer layer 141 to the first elastomer layer 140; a step 904 of embedding components 1 14 in the second elastomer layer 141 ; a step 905 of applying a third elastomer layer 142 to the second elastomer layer 141 ; and/or a step 906 of releasing the device 100. [00273] In preferable embodiments, the mould 14 is the aforementioned pattern or combination of patterns in the shape of the final intended embodiment of the device 100 and the mould cavity 15 is coated with a release agent (e.g., aerosolized fluorocarbon/silicone mixture or Ease Release 200 (Mann Release Technologies)). Alternatively, for the characterization of adhesive performance, the mould 14 is preferably in the shape of a dogbone with a single pattern, or a combination of patterns, in the form of a standardized test sample.

[00274] The first elastomer (e.g., silicone rubber) layer 140 is preferably an adhesive elastomer or a non-adhesive (or body) elastomer. The second elastomer layer 141 is preferably an adhesive of nonadhesive elastomer. In preferable embodiments, if the first elastomer layer 140 is an adhesive elastomer the third elastomer layer 142 is a body elastomer (i.e., non-adhesive) and when the first elastomer layer 140 is a body elastomer the third elastomer layer 142 is an adhesive elastomer.

[00275] The first elastomer layer 140 is preferably uncured and applied by any means to the mould cavity 15. After a first partial cure time (i.e., the time for partial cross-linking of the first elastomer layer 140) of the first elastomer layer 140, the second elastomer layer 141 is preferably uncured and applied to the first elastomer layer 140 and components 114 are preferably embedded in the second layer 141. After a second partial cure time (i.e., the time for partial cross-linking of the second elastomer layer 141, or pot life time) of the second elastomer layer 141, the third elastomer layer 142 is preferably uncured and applied to the second elastomer layer 141. The layers 140, 141, 142 are allowed to substantially cure. [00276] In some preferable embodiments, the components 114 are pre-heated to 50-65°C to facilitate a more rapid solidification of the second elastomer layer 141 and/or to help the components 114 set in place.

Example 3 Process for making the device using a modified open air cure

[00277] FIG. 30 depicts steps of a method 910 for making the device 100 using a modified open air cure. In the description of the method 910, the same reference numerals are used as those which are used, above, with reference to the device 100 described above and shown in FIG. 30, but it is not so limited. [00278] As show in FIG. 30, the method 910 includes the following steps, among others: a step 901 of providing a mould 14 defining a mould cavity 15; a step 902 of applying a first elastomer layer 140 to the mould cavity 15; a step 91 1 of applying an initial half of a second elastomer layer 141a to the first elastomer layer 140; a step 912 of applying components 1 14 partly in the initial half of the second elastomer layer 141a; a step 913 of applying a subsequent half of the second elastomer layer 141b to the initial half of the second elastomer layer 141a; a step 914 of applying a third elastomer layer 142 to the subsequent half of the second elastomer layer 141b; and/or a step 915 of releasing the device 100.

[00279] Preferably, for the modified open air cure, after a first partial cure time of the first elastomer layer 140, the initial half of the second elastomer layer 141a is preferably uncured and applied to the first elastomer layer 140 and components 1 14 are applied to the initial half of the second layer 141a. After a second partial cure time of the initial half of the second elastomer layer 141a, the subsequent half of the second elastomer layer 141b is applied to the initial half of the second elastomer layer 141a. After a third partial cure time, of the subsequent half of the second elastomer layer 141b, the third elastomer layer 142 is preferably uncured and applied to the subsequent half of the second elastomer layer 141b. The layers 140, 141, 142 are allowed to substantially cure.

Example 4

Process for making the device using injection moulding

[00280] FIG. 31 depicts steps of a method 920 for making the device 100 using injection moulding. In the description of the method 920, the same reference numerals are used as those which are used, above, with reference to the device 100 described above and shown in FIG. 31, but it is not so limited.

[00281] As shown in FIG. 31, the method 920 includes the following steps, among others: a step 921 of providing a mould 14 defining a mould cavity 15; a step 922 of applying a first elastomer layer 140 to the mould cavity 15; a step 923 of applying a second elastomer layer 141 to the first elastomer layer 140; a step 924 of applying components 1 14 partly in the second elastomer layer 141; a step 925 of applying a third elastomer layer 142, preferably by injection, to the second elastomer layer 141 ; a step 926 of releasing the device 100; and/or a step 927 of removing artefacts from the third elastomer layer 142.

[00282] Preferably, for injection moulding, the mould 14 comprises a top mould 14a and a bottom mould 14b, that when combined defines a mould cavity 15. The top mould 14a, preferably comprises an injection inlet 16 for injecting an elastomer layer and an ejection port 17 for ejecting excess elastomer layer. The first elastomer layer 140 is preferably uncured and applied to the mould cavity 15. After a first partial cure time of the first elastomer layer 140, the second elastomer layer 141 is preferably uncured and applied to the first elastomer layer 141. The components 114 are also applied to the uncured second elastomer layer 141. After a second partial cure time of the second elastomer layer 141, the third elastomer layer 142 is injected into the moulding cavity 15. The layers 140, 141, 142 are allowed to substantially cure.

[00283] A specific embodiment of the combination of silicone components and preparation used to prepare a herein-described soft skin-adhesive rubber is: a mixture of commercially available base/catalyst/cross-linker mixture DS30® (1.8 mL of A, 1.8 mL of B) and the commercially available deadener, Slacker® (6.4 mL) that was premixed by hand for 3 minutes with 0.2 g of treated pyrogenic silica (Cabot TS-530®), the total mixture of which was stirred by hand for 3 minutes. The mixture was degassed in a vacuum chamber until bubbles of air no longer appreciably escaped the rubber mixture, approximately 3 minutes. The degassed mixture was then poured into a mould that had been coated with fluorocarbon release agent, with a continuous grid of raised hemispheres as the specific pattern, and a depth between the uppermost limit of the patterning and the uppermost surface of the mould being 1.0 mm. After allowing the rubber to settle into the pattern and any incidentally trapped bubbles of air to rise and burst, the excess rubber (that which sat above the upper surface of the mould was removed by a leveling knife. The rubber was then placed in an oven at 65 ° C until the rubber had cured to the stage where, when poked with a needle, the rubber at the needle tip would lift in a semi-fluid manner but would not separate away from the bulk of the rubber (approximately 5-8 minutes depending on exact ambient conditions). The steps until this point comprise the formation of a pressure-sensitive adherent surface. At this point, a fluorocarbon-coated mould top that conveyed the final shape of the "single contiguous rubber body" and conferred a depth of non-adhesive rubber of 2.0 mm (on top of the previously poured adhesive rubber) was placed over the adhesive rubber layer. A mixture of commercially available base/catalyst/cross-linker such as Ecoflex-0050® (5 mL of Part A, 5 mL of Part B), which had been premixed by hand for 3 minutes and degassed in a vacuum chamber until bubbles of air no longer appreciably escaped the rubber mixture (approximately 3 minutes) was injected through a port into the top half of the mould until the inner space was filled. The entire "single contiguous rubber body" was then baked at 65 °C for 30 minutes, whereupon it was demoulded and washed with plain soap and water to remove any fluorocarbon.

[00284] Definition and ratios of the specific components of the silicone mixture

[00285] The base silicone (i.e., Part A) is preferably not less than 2% by weight and not more than 4% by weight of the RTV silicone mixture. Part A preferably includes polysiloxane comprising a PDMS chain with vinyl linking moieties at the polymer chain ends and/or polysiloxane comprising a PDMS chain with vinyl linking moieties at the polymer chain ends and vinyl linking moieties distributed along the polymer chain. A preferable example is the majority component of the commercially available Smooth-On's Dragonskin®. [00286] The silicone cross-linker (i.e., Part B) is preferably not less than 0.1% by weight and not more than 10% by weight of the RTV silicone mixture. Part B preferably includes polysiloxane comprising a PDMS chain with or without vinyl linking moieties at the polymer chain ends, with silyl hydride moieties distributed along the polymer chain. A preferable example is the cross-linking component in Part B of commercially available Smooth-On' s Dragonskin®.

[00287] The silicone deadener is preferably not less than 50% by weight and not more than 90% by weight of the RTV silicone mixture. The deadener preferably includes polysiloxane comprising a short PDMS chain with or without vinyl linking moieties at the polymer chain ends, with or without silyl hydride moieties distributed along the polymer chain and/or polysiloxane comprising a short PDMS chain with hydroxyl moieties at the chain ends, with or without silyl hydride moieties distributed along the polymer chain. A preferable example is Smooth-On's Slacker®.

[00288] The additives are preferably not more than 50% by weight for all additives combined. One such additive is preferably pyrogenic silica, which may be hydrophobic (if treated) or hydrophilic if untreated). Small amounts of silica improve strength without compromising softness. Above about 10 wt% there is a steep increase in rigidity (Young's modulus) and decrease in elongation at break Commercial product examples include Cabot (e.g. TS-530®) or Wacker (e.g. HDK-H20®).

[00289] Another preferable additive is carbon products, which may be greater than 3 wt% but less than about 50 wt% and include carbon black, graphite, and carbon nanotubes (MWCNT, SWCNT). [00290] Other nanomaterials may also serve as additives, at an amount of greater than 1 wt% but less than 10 wt%, including silver nano wires and silver oxide nanoparticles. [00291] Definitions of adhesive properties - Experiments and accompanying recipes demonstrating adhesive / tensile measures (high/low range)

[00292] A sample of soft rubber material consisting of at least one pressure-sensitive adherent surface 124 will display a range of exact performance metrics. [00293] The first is a range of measures of tensile strength of the pressure-sensitive adherent surface 124 component of the body. Preferably between about 1 to about 10 lbs/in 2 ("psi"), more preferably between about 2.0 to about 5.0 psi, as measured by the preparation of a standardized dogbone-shaped test sample, and stretching until break whilst measuring using a calibrated electronic strain gauge. [00294] The second is a range of measures of Young's modulus of the pressure-sensitive adherent component of the body. Preferably between about 0.1 to about 2.0, more preferably between about 0.3 to about 1.3, as measured by the preparation of a standardized dogbone-shaped test sample, and stretching until break whilst measuring using a calibrated electronic strain gauge. [00295] The third is a range of exact measures of tackiness force of the pressure- sensitive adherent surface 124 component of the body. Preferably exerts between about 0.3 to about 5.0 psi of adhesive force, more preferably between about 0.5 to about 3.0 psi of adhesive force, as measured using a vertical peel test; whether un-patterned, using a single pattern, or a combination of patterns. On the un-modified back-of-the-hand epidermis of an adult male with slight body hair, quantified with an electronic strain gauge.

Example 5

Preparation of the preferred, or specific, embodiment [00296] A specific embodiment is a mixture of commercially available base-cross linker- catalyst mixture Dragonskin®-30 (1.8 mL of A, 1.8 mL of B) and commercially available deadener Slacker® (6.4 mL) and prepared as an adhesive as described in the above embodiments as both a single contiguous body with at least one pressure-sensitive adherent surface (e.g., 1.0 mm thickness of adhesive rubber exclusive of patterning depth, with 1.0 mm of Ecoflex®-0050 as a non-adhesive rubber poured without moulding on top) as well as standard dogbones. Furthermore, and the properties of this rubber with measured with the techniques described above. Tensile strength was 2.67 psi, Young's modulus was 0.348, peak tackiness force was 0.84-0.20 psi (dependent on patterned texture) measured using a 25.4 mm wide strip of rubber.

[00297] FIG, 39 is a graph showing the mass flow rate of an embodiment of the present invention.

[00298] Exact chemical compound names

[00299] The aforesaid "Part A" is preferably a vinyl base and catalyst. The base is preferably a Poly(dimethylsiloxane) terminated with vinyl groups or alternately a Poly(dimethylsiloxane) terminated with vinyl groups and containing vinyl groups along the chain. The catalyst is preferably a platinum catalyst, Platinum0-l,3-divinyl-l,l,3,3- tetramethyldisiloxane complex, commonly referred to as Karstedt's catalyst (as little as about 10 ppm, as much as about 100 ppm), as shown in FIG. 32. [00300] The aforesaid "Part B" is preferably a vinyl base and cross-linker. The base is preferably a Poly(dimethylsiloxane) terminated with vinyl groups or alternately a Poly(dimethylsiloxane) terminated with vinyl groups and containing vinyl groups along the chain or Poly(dimethylsiloxane) terminated with vinyl groups that have silyl hydrides to complete the hydrosilylation reaction.

[00301] The aforesaid deadener is preferably silicone fluid, either hydroxyl-terminated or vinyl-terminated: a short chain PDMS with far fewer cross-linking sites (either hydrides or vinyls) than any of the base molecules.

Example 6

Range of Specific Embodiments Explored

[00302] Adhesive Silicone [00303] The following formulations were tested and explored. Letting the percentage of the total composition by volume of Deadener be defined as z, ranging between 20-90%, then Silicone Base Part A = Silicone Base Part B = (100-z)/2, where Silicone Base can be any of the Ecoflex® or Dragon Skin® series or any combination thereof, and pyrogenic silica (e.g. HDK® by Wacker) 0-60vol% of total mixture of Deadener + Silicone base. [00304] Ultrahigh Dielectric and Low-resistivity Soft, Skin-adhesive Silicone Rubber

[00305] The following formulations were tested and explored. Let the percentage of the total composition by weight of deadener be defined as z, and additives in weight percentage are defined as x. Embodiments have been prepared where z as a wt% of total ranges between 50-90%, and the silicone base parts A and B are each (100-(z+x))/2. The base used may be such as the commercially available Dragon Skin® series. Additives may comprise treated pyrogenic silica (e.g. HDK® by Wacker or Cabot TS-530®), carbon black, graphite, or nanomaterials such as carbon nanotubes or silver nanowires. 0-60 wt% of total mixture of Deadener + Silicone base, and 0-30 wt% carbon black of total mixture of Deadener + Silicone base, 0-30 wt% Ag nanoparticles of total mixture of Deadener + Silicone base.

Example 7

Preparation of a preferred, or specific, embodiment of the ultrahigh dielectric and low- resistivity skin-adhesive rubber

[00306] A preferred embodiment of the combination of silicone components and preparation used to prepare an ultrahigh dielectric and low-resistivity skin-adhesive rubber is: 0.8 g of treated pyrogenic silica (Cabot TS-530®), and 0.7 g of multi-walled carbon nanotubes ("MWCNT") of diameter 8-15 nm and length 10-50 μηι (commercially available through CheapTubes) were blended together by hand until the mixture was of a uniform consistency. To this powder, the commercially available deadener, LV® (from PolyTek) (5.4 mL) was added and the mixture was stirred by hand until a smoothly running black rubber was obtained. To this rubber, a pre-mixed (3 minutes by hand) combination of commercially available base/catalyst/cross-linker mixture DS30® (1.55 mL of Part A, 1.55 mL of Part B) and the total mixture was stirred by hand for 3 minutes. The mixture was degassed in a vacuum chamber until bubbles of air no longer appreciably escaped the rubber mixture, approximately 3 minutes. The degassed mixture was then spread onto a fluorocarbon-coated steel surface using a leveling knife. Due to the strong reinforcing nature of the MWCNT-composited rubber, it is not facile to pour. The rubber was then placed in an oven at 120°C for 12 hours, whereupon it was delaminated from the steel surface and washed with plain soap and water to remove any fluorocarbon. Electrical conductivity and dielectric were measure using a matched pair of smooth copper plates, held in an overlapped profile on either side of the rubber surface. Electrical conductivity was measured to be 33 ΙίΩ independent of frequency between 100 Hz - 100 kHz. Dielectric constant was measured to be 2400 at 100 Hz and 1000 at 1 kHz.

Example 8

Description of pre-treatment of electronic devices

[00307] Electronics boards, such as PCBs, with pre-installed electronic components are primed with a silanol such as commercially available Solaris® primer, followed by embedding in a soft silicone rubber such as commercially available Solaris® rubber (or other rubber depending on if rest of patent needs to be dependent upon use of platinum-cure silicone), the reactive groups of which are matched to those in the bulk adhesive/body polymer (e.g. vinyl bonds for platinum-cure silicone).

[00308] Additional Methods of Improving the Durability and Integration of Electronics in Silicone

[00309] (a) Epoxy Potting Compounds [00310] Epoxy compounds are hydrocarbon-based polymers that are formed by a chemical reaction between epoxide ring (C-O-C) moieties and suitable ring-opening agents, typically amines (C-NH 2 ). Epoxies are preferably embodied as separate resin and hardener components, which may be varied to adjust the hardness of the cured material, the cure time, the cure method (e.g., application of heat, ultraviolet light, or simply atmospheric moisture) and other properties known to persons skilled in the art. Epoxies can preferably be designed to bond to a wide variety of substrates by choosing appropriate chemical functional groups for the polymer structure. Epoxies are preferably considered an important segment of engineering adhesives, along with acrylics, polyurethanes and cyanoacrylates.

[00311] (b) Protection of Electronics

[00312] Among coatings and adhesives, epoxies are ideal for applications where a strong adhesive bond and effective stress relief/shock protection are premium. Furthermore, epoxies show robustness to a range of conditions such as high temperature and chemical exposure. When properly cured, epoxies preferably display low outgassing rates. These attributes make epoxies ideal for encapsulating sensitive electronics, especially those that are exposed to adverse environments and long duty cycles; critical applications such as marine, military and space hardware make extensive use of epoxy, where they are preferred over other adhesives known in the art.

[00313] For components 1 14 embedded in the body 1 10, preferably comprising a soft silicone shell, epoxy adhesives are preferable encapsulating coatings. Devices 100 may be exposed to unique stresses, for example frequent or constant acceleration in multiple dimensions, which imparts a large stress load on bonds between components 1 14 and circuit substrates 1 12, which if unaddressed may result in mechanical (and therefore electronic) failures. In the event of flexion of the device 100, internal stresses are generated which impart additional stress on the embedded components 1 14. The body 1 10 (e.g., silicone) is preferably soft and accordingly does not impart the protection provided by a traditional rigid (hard plastic or metal) casing. Therefore, epoxy coating the components 1 14 to be embedded in the body 1 10 preferably serves as additional protection to the components 1 14 encapsulated within the body 1 10. Epoxy coatings, due to the various properties mentioned above, preferably mitigate or prevent many of these failures while preferably protecting from, for example, contaminants in the atmosphere and also those arising from constant use by users 20.

[00314] (c) Electronic-Silicone Integration Improvement [00315] The devices 100 of the present invention are preferably used for applications where greater flexibility, stretching tolerances, and device tactile properties are required. In preferable embodiments, the body 1 10 comprises silicone which has a chemical structure that is less rigid than those of other polymers. As known by persons of skill in the art, silicones typically have low surface energy, which preferably facilitates wetting of many surfaces to which the silicone is adhered. As may be understood by persons skilled in the art, the curing of standard polyorganosiloxane polymers into a solid structure via cross- linking reactions does not directly result in a covalent bond to the adherend; rather, hydrogen bonds and dispersion forces at the surface, are preferably maximized by the wetting properties of silicone. [00316] For components 1 14, the use of silicones for the body 1 10 may be a disadvantage when compared to epoxies for bonding force. PCBs are preferably coated with a solder mask as a final treatment, to prevent unwanted bridging of circuitry; the solder mask is commonly based on epoxy because of the aforementioned adherence and other properties known to persons skilled in the art. When applying an epoxy adhesive to an epoxy solder mask, the chemical similarity preferably provides a strong adhesive force. Conversely, as there may not be a chemical or covalent bond between silicones and rigid PCBs and/or other components 1 14, delamination typically occurs due to large stresses placed upon a silicone-coated PCB; the hardness mismatch between the silicone coating and the PCBs may limit the amount of force which may be transferred from the substrate or adherend to the adhesive, and vice versa. By applying an epoxy coating preferably having a softer modulus (i.e., MPa range) between a PCB and a silicone coating, this limitation is preferably alleviated by forming a "hardness gradient," such that stress forces are effectively transmitted and delamination is lessened.

[00317] In a preferable example, a common solder mask is VACREL® 8100 (E.I. du Pont de Nemours and Company, Wilmington, Delaware) preferably having a modulus of 2.1 -3.3 GPa can be coated in Loctite™ Hysol ES I 901 (Henkel Corporation, Westlake, Ohio), which preferably has a modulus of 4.9 MPa. The epoxy is preferably fully cured before embedding in platinum-cured silicone due to the inhibitory effects of amine-based curing epoxies.

[00318] To further enhance the integration of the components 1 14 in the body 1 10, surface preparation techniques (e.g., epoxy coating) are preferably used on the adherend, PCB, prior to encapsulation in, for example, silicone. Plasma cleaning is a preferable surface preparation method, the goal of which is the treatment of a substrate, or an adherend, to enhance adhesion. In the prior art, sanding and priming have been used to achieve enhanced adhesion. Plasma cleaning, however, has been used in industries involving high- performance polymers and microelectronics, as well as derivatives thereof, to effectively and non-destructively increase the surface energy of a substrate or adherend, which preferably has a great effect on the long-term durability and permanent effectiveness of an adhesive or coating. [00319] "Plasma", as may be known by persons of skill in the art, preferably refers to ionized gas molecules. Plasma is preferably generated using high-frequency fields (e.g., kHz-MHz) with both gaseous elements such as oxygen and nitrogen, as well as gaseous chemicals. In the prior art, a vacuum environment is used to achieve the conditions necessary for stable plasma, such that it may be harnessed for use in various applications. However, ionized gas molecules are by nature unstable and highly reactive, which is advantageous for the present invention. At the species constituting plasma are ionized molecules, free radicals, free electrons, and high-energy photons, the species react with both contaminants on the surface (i.e., removing them) and the uppermost layer of the substrate or adherend, uniformly functionalizing it depending on the gaseous medium. The end result is a high-energy surface with little to no impurities for ideal adhesive application. It is also preferably believed that chain scission (i.e., the breaking of a molecular bond causing the loss of a side group or shortening of a chain) may result in greater chain mobility at the interface of the body 1 10 and substrate or adherend, allowing for enhanced interpenetration of the applied material (i.e., body 1 10). An increase in adhesive vertical peel force of about 500-800% is not uncommon.

[00320] More recently, atmospheric plasma cleaning has been used in the prior art to functionalize plastics and other industrial commodities in a high-throughput manner. This method is highly conducive to volume production; rather than requiring a batch-wise vacuum apparatus, a stream can be directed at pressure towards surfaces to be cleaned, in ambient conditions. A field of sufficiently high frequency (i.e., an alternating current of sufficiently high frequency of oscillation - for example, about 1 to about 100 kHz and voltage greater than or equal to about 1 kV) is preferably passed over a cavity through which gas is blown. The gas may be ambient air, or a specifically chosen chemical or element. The plasma stream is preferably directed over an assembly line in a jet or as a curtain, as well as wielded by robots for targeted treatment. With high-performance electronics, plasma- generating apparatuses have decreased drastically in size and increased in portability, making them easy to implement. Plasma cleaning can be combined with more traditional techniques such as priming to further compatibilize a surface with the cure chemistry of adhesives such as silicone. Furthermore, the temperature of the plasma is the same as ambient conditions, making it non-destructive to the device 100.

[00321] Machine Learning [00322] Algorithms 801a,b, 802a,b, 803a,b, 804a,b, 805a,b, 806a,b, 807a,b, 808a,b, 810a,b preferably employ a machine learning algorithm 809a,b (alternately known as a classifier 809a,b) to facilitate the determination of correlations from the data 26, 27 and the variability between users 20 (e.g., genetics, fitness level, age and health). One or more classifiers 809a,b, are preferably trained using the data 26, 27, and the system 50 - preferably using the parent and/or remote / cloud-based processor(s) - learns or determines machine data 30 which preferably comprises information (or metrics) that optimizes identification and classification of the data 26, 27 while accounting for the variability between users 20. In accordance with the present invention, the classifier 809a,b preferably identifies a subtype or category to which a new observation or new information belongs. For example, biological data 26 such as heart rate may be classified as cardiovascular information. Machine learning advantageously provides for the analysis of current, and the prediction of future, data 26, 27. [00323] In preferable embodiments, once trained, the classifier 809a,b does not need to be re-trained. Machine data 30 is preferably maintained in the parent database 71, but may also be stored in the device database 62 and/or remote database(s) 83. A user processor (not shown) and/or the device processor 90a, executing a user-facing application (not shown), are preferably adapted to access the machine data 30. Using the machine data 30, the user processor and/or the device processor 90a preferably calculates predictions on the data 26, 27.

[00324] In preferable embodiments, specific types of user data 26 - for example, comprising electrocardiogram information - may be divided according to discrete time intervals (e.g., 1 minute intervals, 5 minute intervals, etc.) for training and/or testing the classifier 809a,b. Preferably, the divided data is used via cross correlation techniques to train and/or test the classifiers.

[00325] FIG. 33 depicts a preferable example, of an application of the machine learning algorithm 809a,b. User data 26, such as ECG information, is collected by the device 100 (See, for example, Section 1). ECG information is preferably processed by the user processor, the device processor 90a, the parent processor 90b, and/or the remote / cloud- based processor using a time-frequency analysis know to persons of skill in the art to extract statistical measures of the changing heart rate from beat-to-beat (i.e., standard deviation of R-R interval times, root mean square of successive difference, etc.) and the power spectral density ("PSD") of the frequency of the heart beats (i.e., total power in the low and high frequency bands (See, for example, Section 2). Specific metrics, such as the distribution of frequencies within the respective bands (high and low frequencies), are preferably used to improve the division of the data 26. The data 26 is processed by the classifier 809a,b (See, for example, Section 3) comprising an ensemble based extra random forest classifier trained using information containing expert and novice meditators as well as sleep data and a database containing drivers undergoing higher levels of stress, to predict the mindfulness (See, for example, Section 4) of the user 20.

Example 9

Device comprising gyroscope with haptic feedback

[00326] FIG. 34 depicts a device 100 comprising a body 1 10 and an adhesive pad 120 embedded with a printed circuit board 1 12 connected to a gyroscope 67 and a vibration generator 91 for haptic feedback. The gyroscope 67 is preferably a 6-axis gyroscope and the device 100 preferably further comprises an accelerometer 68, a transmitter-receiver 61 and/or additional components 1 14. As shown in FIG. 34, the device 100 preferably also comprises an input-output component 66 (e.g., LED), a power supply 1 16, and a charging coil 1 16b configured for wireless charging. In preferable embodiments, the charging coil 1 16b comprises copper coil and ferrite (not shown).

[00327] FIG. 35 depicts a device 100 comprising a body 1 10 and an adhesive pad 120, having a rounded shape, with a printed circuit board 1 12 connected to an accelerometer 68 and a vibration generator 91 for haptic feedback. The device 100 preferably further comprises a transmitter-receiver 61 and/or additional components 1 14. Example 10

Device comprising flexible piezoelectric sensor [00328] FIGS. 23 A shows a device 100 comprising a body 110 and an adhesive pad 120 embedded with a sensor 64, preferably piezoelectric. The components 1 14 are preferably positioned in relation to lines of flexation 118 to facilitate flexing of the device 100. The sensor 64 preferably projects from the printed circuit board 112 at an anchor point 64a. Preferably, the device 100 further comprises a power supply 1 16 and a charging coil 116b configured for wireless charging.

Example 11

Device comprising piezoelectric sensor with haptic feedback

[00329] FIG. 23B depicts a device 100 comprising a body 1 10 and an adhesive pad 120 embedded with a sensor 64, preferably piezoelectric. The sensor 64 preferably projects from the printed circuit board 1 12 at an anchor point 64a. Preferably, the device 100 further comprises a power supply 1 16, a charging coil 116b, and a vibration generator 91.

Example 12

Haptic communication

[00330] FIG. 36 depicts a device 100 comprising a sensor and/or vibration generator (not shown) to generate haptic feedback for communication. A user 20a preferably contacts the device 100a (e.g., multiple taps, tap cadence, etc.) comprising a sensor (e.g., piezoelectric) that collects the vibrations as biological data 22 of the user 20a. A device 100b associated with user 20b preferably receives the biological data 22 from user 20a and transforms the data 22 into a corresponding haptic profile generated by the vibration generator. In some preferable embodiments the devices 100a, 100b directly transfer the data 22; while in other preferable embodiments, the data 22 is transferred using the system 50. As shown in FIG. 36, the system 50 is preferably adapted to facilitate receipt of the data 22 by a plurality of users 20b.

Example 13

Haptic guided navigation [00331] FIG. 37 depicts devices 100 configured for haptic guided navigation. The device 100 preferably comprises one or more vibration generators (not shown). In a preferred embodiment, a user 20 positions devices 100 on each arm and over a central axis of the body of the user 20. The devices 100 are configured to direct the user 20 to turn left with the generation of a haptic signal from the device over the central axis and on the left arm of the user 20. The devices 100 are configured to direct the user 20 to turn right with the generation of a haptic signal from the device over the central axis and on the right arm of the user 20. In alternate preferred embodiments, the user 20 is directed to turn using a device 100 with two or more vibration generators on either side of the device 100 (in accordance with FIG. 37) whereby generation of a vibration by one vibration generator directs the user 20 to turn in one direction and generation of a vibration by another generator directs the user 20 to turn in another direction. In another preferred embodiment, the user 20 is directed to turn using a device 100, positioned in any location on the user 20, with one vibration generator that generates, for example, one vibration to turn on one direction and two vibrations to turn in another direction. [00332] FIGS. 38 A show, respectively, top and side views of a device 100 with two vibration generators 91 embedded within the body 1 10 on different ends of said device 100. As best seen in FIG. 38B, the components 1 14 are associated with the printed circuit boards 1 12. This alternate embodiment of the device 100 is preferably used for haptic guided navigation.

Example 14

Situational awareness

[00333] Where data 22, 24, 26, 27, 28, 29, 30 is collected on all users 20 of individual teams or military units, their intrinsic data 22 is preferably compared to identify weak and strong links in the collective. For example, a basketball coach can determine which player has slept well and is prone to high performance, or which player is not focused and is prone to injury.

Example 15

Social product awareness

[00334] Where data 22, 24, 26, 27, 28, 29, 30 is collected on users 20 of a particular demographic or geographic region, reactions to advertisement or acceptance and rejection of new products can be gauged, controlled for geographic region and demographic.

Example 16 Polyphase sleep support

[00335] Collecting data 21, 22, 24, 26, 27, 28, 29, 30 on different phases of sleep. Preferably comparing certain biologic data 22, such as polyphase sleep data, of users 20 against population data 21, e.g., sports team, military unit, city, country, particular demographic etc. and overlaying with other extrinsic data 29. [00336] This concludes the description of presently preferred embodiments of the invention. The foregoing description has been presented for the purpose of illustration and is not intended to be exhaustive or to limit the invention to the precise form disclosed. Other modifications, variations and alterations are possible in light of the above teaching and will be apparent to those skilled in the art, and may be used in the design and manufacture of other embodiments according to the present invention without departing form the spirit and scope of the invention. It is intended the scope of the invention be limited not by this description but only by the claims forming a part hereof.