U.S. patent application number 14/574220 was filed with the patent office on 2015-06-25 for sensors, interfaces and sensor systems for data collection and integrated remote monitoring of conditions at or near body surfaces.
The applicant listed for this patent is Sensoria Inc.. Invention is credited to Mario ESPOSITO, Maurizio MACAGNO, Davide Giancarlo VIGANO'.
Application Number | 20150177080 14/574220 |
Document ID | / |
Family ID | 48868978 |
Filed Date | 2015-06-25 |
United States Patent
Application |
20150177080 |
Kind Code |
A1 |
ESPOSITO; Mario ; et
al. |
June 25, 2015 |
SENSORS, INTERFACES AND SENSOR SYSTEMS FOR DATA COLLECTION AND
INTEGRATED REMOTE MONITORING OF CONDITIONS AT OR NEAR BODY
SURFACES
Abstract
Sensing devices including flexible and stretchable fabric-based
pressure sensors may be associated with or incorporated in garments
intended to be worn against a body surface (directly or
indirectly), or may be associated with other types of flexible
substrates, such as sheet-like materials, bandages, and other
materials that contact the body (directly or indirectly), and may
be provided as independently positionable sensor components.
Systems and methods for storing, communicating, processing,
analyzing and displaying data collected by sensor components for
remote monitoring of conditions at body surfaces, or within the
body, are also disclosed. Sensors and sensor systems provide
substantially real-time feedback relating to current body
conditions and may provide notifications or alerts to users,
caretakers, and/or clinicians, enabling early intervention when
conditions indicate intervention is appropriate.
Inventors: |
ESPOSITO; Mario; (Redmond,
WA) ; MACAGNO; Maurizio; (Redmond, WA) ;
VIGANO'; Davide Giancarlo; (Redmond, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sensoria Inc. |
Redmond |
WA |
US |
|
|
Family ID: |
48868978 |
Appl. No.: |
14/574220 |
Filed: |
December 17, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13753456 |
Jan 29, 2013 |
8925392 |
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14574220 |
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61592333 |
Jan 30, 2012 |
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61747877 |
Dec 31, 2012 |
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Current U.S.
Class: |
2/239 ;
73/862.01 |
Current CPC
Class: |
A61B 5/6831 20130101;
A61B 5/1038 20130101; A61B 2560/0223 20130101; A61B 2562/0247
20130101; A61B 5/01 20130101; G16H 40/67 20180101; A43B 17/00
20130101; G01L 1/18 20130101; A61B 2560/045 20130101; A43D 1/027
20130101; A61B 5/024 20130101; A61B 5/1036 20130101; A61B 5/11
20130101; A61B 5/447 20130101; A61B 5/6807 20130101; A61B 5/002
20130101; A61B 2562/227 20130101 |
International
Class: |
G01L 1/18 20060101
G01L001/18; A43B 17/00 20060101 A43B017/00; A61B 5/024 20060101
A61B005/024; A61B 5/11 20060101 A61B005/11; A61B 5/103 20060101
A61B005/103; A61B 5/01 20060101 A61B005/01 |
Claims
1. A sensing device comprising: at least one piezoresistive fabric
sensor; at least two electrically conductive leads extending from
each piezoresistive fabric sensor; at least one electrically
conductive trace connected to each conductive lead; and at least
one signal transfer terminal electrically connected to each
conductive trace; wherein each trace is fabricated from a Material
having different properties from the piezoresistive fabric sensor
and lead material, and at least one piezoresistive fabric sensor,
at least two electrically conductive leads, at least one
electrically conductive trace, and at least one signal transfer
terminal is associated with a non electrically conductive substrate
that is flexible and stretchable.
2. The sensing device of claim 1, additionally comprising at least
one additional non-fabric sensor.
3. The sensing device of claim 1, wherein the at least one
piezoresistive fabric sensor is capable of sensing pressure or
force exerted on the sensor.
4. The sensing device of claim 1, wherein the at least two
electrically conductive fabric leads extending from the at least
one piezoresistive fabric sensor and are formed as integral
extensions of the at least one piezoresistive fabric sensor.
5. The sensing device of claim 1, wherein the at least two
electrically conductive leads are positioned on opposite sides of
the at least one piezoresistive fabric sensor.
6. The sensing device of claim 1, wherein the non-electrically
conductive substrate is in the form factor of an insole, shoe,
boot, belt or strap.
7. The sensing device of claim 1, wherein the non-electrically
conductive substrate is in the form factor of a wearable
garment.
8. The sensing device of claim 7, wherein the non-electrically
conductive substrate is in the form factor of a sock or an
anklet.
9. The sensing device of claim 7, wherein the wearable garment is
selected from the group consisting of: shirts, underwear, leggings,
footies, gloves, caps, body bands and brassieres.
10. The sensing device of claim 1, wherein the non-electrically
conductive substrate is in the form of a bandage, wrap, band, wound
dressing, sheet or pad.
11. The sensing device of claim 1, additionally comprising at least
one sensor capable of sensing at least one of moisture and
temperature.
12. The sensing device of claim 1, additionally comprising a
dedicated electronic device having signal receipt terminals that
mate with signal transfer terminals of the sensing device and a
housing component with signal processing and communications
components located within the housing component.
13. The sensing device of claim 12, wherein the housing component
is flexible.
14. The sensing device of claim 12, wherein the housing component
of the dedicated electronic device is in the form of a curved
housing configured to fit partially around the front portion of a
user's lower leg or ankle.
15. The sensing device of claim 12, wherein the signal receipt
terminals of the dedicated electronic device and the signal
transfer terminals of the sensing device are mounted in cooperating
fixtures for sliding engagement of terminals.
16. The sensing device of claim 12, wherein the signal receipt
terminals of the dedicated electronic device and the signal
transfer terminals of the sensing device are configured for
magnetic engagement of terminals.
17. The sensing device of claim 12, additionally comprising an
accelerometer.
18. A sock comprising at least two piezoresistive sensors; at least
two electrically conductive leads extending from each
piezoresistive sensor: at least one electrically conductive trace
connected to each of the conductive leads: and at least one signal
transfer terminal electrically connected to each of the conductive
traces; wherein the signal transfer terminals are arranged in
proximity to one another in a location corresponding to a front
portion of a users lower leg or ankle region.
19. The sock of claim 18, in combination with a dedicated
electronic device having signal receipt terminals that mate with
signal transfer terminals of the sock and a flexible housing
component in the form of a curved housing configured to fit
partially around the front portion of a user's lower leg or ankle,
with signal processing and communications components located within
the housing component.
20. A system for data collection and remote monitoring of
conditions at or near a body surface, comprising: at least one
sensing device configured for positioning in direct or indirect
contact with a portion of a user's body surface and having signal
transfer terminals associated with a flexible, non-conductive
substrate; a dedicated electronic device having signal processing
and communications components and signal receipt terminals that
receive signals from the signal transfer terminals of the sensing
device; and a remote computing facility configured to receive data
from the dedicated electronic device and execute data analysis in
accordance with at least one of programmed and programmable
instructions and routines, wherein the at least one sensing device
comprises at least one piezoresistive fabric sensor; at least two
fabric leads extending from each piezoresistive fabric sensor; and
at least one electrically conductive trace connected to each
conductive lead and terminating in one of the signal transfer
terminals.
21. A method for fitting footwear to a users feet, comprising:
placing at least one pressure sensor of a sensing device comprising
a flexible, piezoresistive sensor, at least two flexible leads
connected to the sensor, at least one flexible, electrically
conductive trace connected to each of the leads, and at least one
signal transfer terminal electrically connected to each of the
flexible, conductive traces at a location at or near an area of the
user's foot; placing footwear on the user's foot and thereby
locating the at least one pressure sensor between the user's foot
and the footwear; collecting data relating to sensed pressure
conditions while the user wears the footwear; augmenting collected
data with user information; and providing user-specific
recommendations for footwear that fits the anatomy of the user's
foot.
22. The method of claim 21, wherein the at least one pressure
sensor is incorporated in a sock form factor.
Description
REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application is a divisional application of U.S. patent
application Ser. No. 13/753,456, filed Jan. 29, 2013, which claims
priority from U.S. Provisional Patent Application No. 61/592,333,
filed Jan. 30, 2012 and from U.S. Provisional Patent Application
No. 61/747,877 filed Dec. 31, 2012. The disclosures of the previous
applications are incorporated by reference herein in their
entireties.
FIELD
[0002] The present invention relates generally to sensors,
including flexible and stretchable fabric-based pressure sensors,
that may be associated with or incorporated in garments intended to
be worn against a body surface (directly or indirectly). Sensors
may also be associated with or incorporated in sheet-like
materials, bandages and other accessories that contact the body
(directly or indirectly), and may be provided as independently
positionable sensor components. Systems and methods for storing,
communicating, processing, analyzing and displaying data collected
by sensor components for remote monitoring of conditions at body
surfaces, or within the body, are also disclosed. Sensors and
sensor systems provide substantially real-time feedback relating to
current body conditions and may provide notifications or alerts to
users, caretakers and/or clinicians, enabling early intervention
when conditions indicate intervention is appropriate.
BACKGROUND
[0003] Various types of sensing systems have been incorporated in
shoes, insoles, socks and garments for monitoring various
physiological parameters for various applications, including
recreational, sporting, military, diagnostic and medical
applications. Medical applications for sensing pressure,
temperature and the like for purposes of monitoring neuropathic and
other degenerative conditions with the goal of alerting individual
and/or medical service providers to sensed parameters that may
indicate the worsening of a condition, lack of healing, and the
like, have been proposed. Footwear-related sensing systems directed
to providing sensory data for patients suffering from neuropathy,
for gait analysis, rehabilitation assessment, shoe research, design
and fitting, orthotic design and fitting, and the like, have been
proposed.
[0004] Potential causes of peripheral neuropathy include diabetes,
alcoholism, uremia, AIDS, tissue injury and nutritional
deficiencies. Peripheral neuropathy is one of the most common
complications of diabetes and results in wounds, ulcers, etc.,
which may be undetected and unsensed by the individual. There are
25 million diabetics in the US alone, with a projected population
of 500 million diabetics worldwide by 2030. In the presence of
neuropathy, diabetic patients often develop ulcers on the sole of
the foot in areas of moderate or high pressure and shear, often
resulting from walking during normal daily activities. About 70% of
diabetics have measurable neuropathy, and every year about 5% of
those patients get foot ulcers, and about 1% requires amputations.
Foot ulcers are responsible for more hospitalizations than any
other complication of diabetes and result in at least $40 billion
in direct costs annually.
[0005] There is strong evidence that uncomplicated plantar ulcers
can be healed in 6-8 weeks, yet current US clinical trials have
reported a 76% treatment failure rate at 12 weeks. Many approaches
to monitoring diabetic patients for the purpose of preventing
ulceration from occurring, or to facilitate healing of existing
ulcers, have been proposed, yet little or no improvement in
ulceration or its complications has been observed. Off-loading may
be an important aspect of ulcer prevention and healing. In
"Practical guidelines on the management and prevention of the
diabetic foot," the authors concluded that mechanical off-loading
is the cornerstone of treatment for ulcers with increased
biomechanical stress. See, Diabetes Metab. Res. Rev. 2008; 24
(Suppl 1): S181-S187. It has been demonstrated that the offloading
capacity of custom-made footwear for high-risk patients can be
effectively improved and preserved using in-shoe plantar pressure
analysis as guidance for footwear modification, which should reduce
the risk of pressure-related diabetic foot ulcers. See, e.g.,
Diabet. Med. 2012 December;29 (12):1542-9. Sensing devices and
footwear having sensors incorporated for monitoring pressure and
other body parameters have been proposed. These devices have
generally not been successful in preventing ulceration or
accelerating healing of wounds, in part as a result of poor patient
compliance. Notwithstanding the existence of several pressure
sensing systems, the incidence of, patient pain and costs
associated with diabetic ulcers has not declined. In one aspect,
the components and assemblies for collection and analysis of data
from sites such as feet and other body surfaces described herein
are directed to providing intermittent or continuous monitoring and
reporting of body conditions (such as pressure) at body locations
for purposes of reducing the incidence and severity of ulcers and
other wounds and accelerating the pace and quality of wound
healing. In other aspects, sensors, interfaces, systems and
materials described herein for collection and analysis of
physiological and biomechanical data from sites such as feet and
other body parts may be used for a variety of sports-related,
military, fitness, diagnostic and therapeutic purposes.
SUMMARY
[0006] In one aspect, sensor systems of the present invention
comprise one or more sensor(s) mounted to or incorporated in or
associated with a substrate material such as a wearable garment, a
wearable band, an independently positionable component, or another
substrate, such as a flexible and/or pliable sheet material. In one
aspect, sensors are capable of sensing a physiological parameter of
the underlying skin or tissue, or sensors are capable of sensing
force or pressure exerted on or against an underlying skin or
tissue. Each sensor is electrically connected, via one or more
flexible leads, to a flexible conductive trace mounted to or
incorporated in or associated with the substrate, and conductive
traces terminate at conductive signal transfer terminals mounted to
or incorporated in or associated with the substrate. Sensor systems
and sensing devices described herein preferably comprise at least
one flexible sensor (or means for sensing), and one or more of the
sensor(s), flexible leads, and conductive traces may be stretchable
and/or elastic as well as being flexible. In some embodiments, the
sensor(s), flexible leads and conductive traces may all comprise
flexible, pliable electrically conductive fabric materials.
Garments incorporating such sensor systems and sensing devices may
be comfortably worn by users under many conditions, providing real
time monitoring of conditions at or near body surfaces to the user,
a caretaker, and/or clinician.
[0007] The signal transfer terminal(s) on the substrate may be
matingly received in signal receipt terminals associated with a
Dedicated Electronic Device (DED) that is attachable to the
substrate and serves as a (temporary or permanent) data collection
device. The DED may also (optionally) house batteries or other
energy storage devices and serve as a sensor charging device. The
DED communicates with one or more external electronic device(s),
such as a smartphone, personal computing device/display, host
computer, or the like for signal transfer, processing, analysis and
display to a user and/or others. In some embodiments, the external
electronic device, and/or the DED, communicates with an external,
hosted computing system (operated, e.g., at a centralized, hosted
facility and/or in the "Cloud") that provides additional data
analysis, formulates feedback, notifications, alerts, and the like,
that may be displayed to the user, a caretaker, and/or a clinician
through one or more computing and/or display devices.
[0008] In some embodiments, one or more sensor(s) detect changes in
voltage or resistance across a surface area that is associated with
force exerted on the sensor, which is related to pressure (as force
per unit surface area) and/or shear. In some embodiments, FSR
(Force Sensitive Resistor) or piezo-resistive sensors may be used.
One type of piezoresistive force sensor that has been used
previously in footwear pressure sensing applications, known as the
FLEXIFORCE.RTM. sensors, can be made in a variety of shapes and
sizes, and measure resistance, which is inversely proportional to
applied force. These sensors use pressure sensitive inks with
silver leads terminating in pins, with the pressure sensitive area
and leads sandwiched between polyester film layers. FLEXIFORCE.RTM.
sensors are available from Tekscan, Inc., 307 West First Street,
South Boston, Mass. 02127-1309 USA. Other types of sensors may also
be integrated in or associated with various substrate materials
(e.g., garments, sheet materials and the like), including sensors
providing data relating to temperature, moisture, humidity, stress,
strain, heart rate, respiratory rate, blood pressure, blood oxygen
saturation, blood flow, local gas content, bacterial content,
multi-axis acceleration, positioning (GPS) and the like. A variety
of such sensors are known in the art and may be adapted for use in
sensing systems described herein.
[0009] In some embodiments, pressure sensors and/or associated
leads and/or conductive traces incorporated in sensing systems of
the present invention comprise non-silicon-based materials such as
flexible, conductive "e-textile" fabric material(s). In some
embodiments, sensors and/or associated leads and/or conductive
traces incorporated in sensing systems of the present invention
comprise flexible, conductive fabric materials that are
substantially isotropic with respect to their flexibility and/or
stretch properties. By "substantially" isotropic, we mean to
include materials that have no more than a 15% variation and, in
some embodiments, no more than a 10% variation in flexibility
and/or stretch properties in any direction, or along any axis of
the material. Suitable materials, such as piezoresistive fabric
sensors, coated and/or impregnated fabrics, such as metallic coated
fabric materials and fabric materials coated or impregnated with
other types of conductive formulations, are known in the art and a
variety of such fabric sensors may be used. In some embodiments,
pressure sensors comprise flexible conductive woven fabric material
that is stretchable and/or elastic and/or substantially isotropic
with respect to their flexibility and/or stretch properties.
[0010] Fabrics comprising a knitted nylon/spandex substrate coated
with a conductive formulation are suitable for use, for example, in
fabricating biometric pressure sensors and in other applications
requiring environmental stability and conformability to irregular
configurations. One advantage of using these types of e-textile
sensors is that they perform reliably in a wide variety of
environments (e.g. under different temperature and moisture
conditions), and they're generally flexible, durable, washable, and
comfortably worn against the skin. Suitable flexible conductive
fabric materials are available, for example, from VTT/Shieldex
Trading USA, 4502 Rt-31, Palmyra, N.Y. 14522, from Statex
Productions & Vertriebs GmbH, Kleiner Ort 11 28357 Bremen
Germany, and from Eeonyx Corp., 750 Belmont Way, Pinole, Calif.
94564.
[0011] Techniques for deriving force and/or pressure measurements
using e-textile fabric materials are known in the art and various
techniques may be suitable. See, e.g.,
http://www.kobakant.at/DIY/?p=913. Techniques for measuring other
parameters using e-textile fabric materials, such as humidity and
temperature measurements, are also known and may be used in sensing
systems of the present invention. See, e.g.,
http://www.nano-tera.ch/pdf!posters2012/TWIGS105.pdf. Fabric
sensors of the present invention may thus be capable of monitoring
various parameters, including force, pressure, humidity,
temperature, gas content, and the like, at the site. Additional
monitoring capabilities may be available using fabric sensors as
innovation in fabric sensors proceeds and as nano-materials and
materials incorporating nano-structures are developed and become
commercially feasible. Flexible (and optionally stretchable or
elastic) conductive fabric sensor(s), leads and/or traces may be
mounted to/in/on, or associated with, an underlying substrate such
as fabric or sheet material that's non-conductive and flexible. The
term "fabric" or "sheet material" as used herein, refers to many
types of pliable materials, including traditional fabrics
comprising woven or non-woven fibers or strands, as well as fiber
reinforced sheet materials, and other types of flexible sheeting
materials composed of natural and/or synthetic materials, including
flexible plastic sheeting material, pliable thermoplastic, foam and
composite materials, screen-like or mesh materials, and the like.
The underlying substrate may comprise a sheet material fabricated
from flexible fabric material that is stretchy and/or elastic. The
sheet material forming the underlying substrate may be
substantially isotropic with respect to its flexibility and/or
stretch properties. By "substantially" isotropic, we mean to
include materials that have no more than a 15% variation and, in
some embodiments, no more than a 10% variation in flexibility
and/or stretch properties in any direction, or along any axis of
the material.
[0012] For garment applications, for example, one or more sensor(s)
and/or sensing devices may be mounted to (e.g., sewn or otherwise
attached or connected or fixed to) an internal surface of a garment
for contacting an individual's skin, directly or indirectly, during
use, and detecting pressure exerted against an individual's skin,
or other parameters sensed at or near a skin surface. In situations
where pressure or other parameters are desired to be measured as
they impact an outer surface or fabric layer, one or more sensor(s)
may be mounted (e.g., sewn or otherwise attached or connected or
fixed to) an external surface of a garment. For applications such
as bands, bandages and independently positionable sensing
components, sensors may likewise be mounted to/in/on, or associated
with (e.g., sewn or otherwise attached or connected to or fixed to)
an underlying substrate that may be conveniently positioned as
desired by the user, a caretaker or clinician. In alternative
embodiments, conductive yarns and/or e-textile fabric sensors may
be knitted into, sandwiched between substrate layers (as in
compression socks) or otherwise incorporated in fabric
substrates.
[0013] In some embodiments, conductive fabric sensors may be
partially or fully enclosed in a flexible barrier material or
envelope. Conductive fabrics employed for the sensors, leads and/or
traces are generally water resistant and water resistant fabrics
are suitably used, without the use of a barrier, for many
applications. In cases where the sensor is frequently exposed to
body fluids, natural liquids or other solutions (e.g., water,
sweat, other bodily fluids) however, the e-properties (e.g.,
electrical conductivity) of the material can be negatively affected
by fluid contact and build-up of biological or other debris. To
mitigate this condition, a substantially liquid impervious barrier
may be provided to protect the sensor(s), leads and/or traces from
direct contact with liquids or other materials. In some
embodiments, a sandwich approach in which a conductive sensor is
enclosed in a substantially liquid impervious barrier may be
employed to protect the sensor from contact with liquids and
preserve the core resistive features (e-properties) and functions
of the sensor(s). Providing a protective barrier covering and/or
enclosing the sensor(s) may also be particularly useful in cases
when the sensor(s) cannot be exposed directly to an open wound or
to a particularly sensitive area of human skin. The barrier may be
placed to seal the sensor(s) alone, or the leads and/or traces may
be sealed as well. When protected sensing components are used,
external surface(s) of the barrier layer(s) may be attached to the
underlying substrate (e.g., garment, skin or the like) via adhesive
materials or in other ways.
[0014] Each sensor is generally associated with two conductive
leads, and each of the leads is electrically connected to a
conductive trace conveying electrical signals to a signal transfer
terminal. Conductive e-textile fabric sensors as previously
described may be electrically connected to conductive leads, or may
have a flexible fabric lead associated with or incorporated in the
fabric sensor footprint. In general, flexible, conductive e-textile
leads may comprise conductive fabric materials having high
electrical conductivity. Other types of flexible leads, including
conductive yarns, fibers, and the like may also be used. The
conductive leads are electrically connected to flexible conductive
traces, which may comprise a variety of flexible conductive
materials, such as a conductive fabric, conductive yarn, or the
like. In some embodiments, the conductive traces are stretchable
and/or elastic, at least along the longitudinal axis of the
conductive trace. In some embodiments, conductive traces comprise a
conductive e-textile fabric having high electrical conductivity,
such as silver coated e-textile materials, and may be bonded to the
underlying substrate material using adhesives, heat bonding or non
conductive threads. Suitable e-textile materials are known in the
art and are available, for example, from the vendors identified
above.
[0015] Sensor(s) as described herein and sensor systems, including
fabric e-textile pressure sensors and a variety of other types of
sensors, with conductive leads and traces, may be associated with a
variety of substrates including, without limitation, garments
intended to be worn (directly or indirectly) against the skin of an
individual, such as a shirt or tunic, underwear, leggings, socks,
footies, gloves, caps, bands such as wrist bands, leg bands, torso
and back bands, brassieres, and the like. Sensors and sensor
systems may additionally be associated with wraps having different
sizes and configurations for fitting onto or wrapping around a
portion of an individual's body, and with bands, bandages, wound
dressing materials, as well as with other types of accessories that
contact a user's body surface (directly or indirectly) such as
insoles, shoes, boots, belts, straps, and the like. Conductive
leads associated with each sensor are electrically connected to
conductive traces, as described, which terminate at signal transfer
terminals associated with the underlying substrate garment, band,
wrap, bandage, or the like.
[0016] Each of the conductive traces terminates in a signal
transfer terminal that is mounted to/in/on, or associated with, the
underlying substrate and can be associated with a mating signal
receipt terminal of a dedicated electronic device (DED) having data
storage, processing and/or analysis capabilities. In general,
conductive traces and terminals are arranged in a predetermined
arrangement that corresponds to the arrangement of signal receipt
terminals in the DED. Many different types of signal transfer and
receipt terminals are known and may be used in this application. In
one exemplary embodiment, signal transfer and receipt terminals may
be mounted in cooperating fixtures for sliding engagement of the
terminals. In another embodiment, signal transfer terminals may be
provided as conductive fixtures that are electrically connected to
the conductive trace (and thereby to a corresponding sensor) and
detachably connectible to a mating conductive fixture located on
the DED. The mating terminals may comprise mechanically mating,
electrically conductive members such as snaps or other types of
fasteners providing secure mechanical mating and high integrity,
high reliability transfer of signals and/or data. In some
embodiments, easy and secure mating of the terminals may be
enhanced using magnetic mechanisms or other types of mechanisms
that help users to properly connect/disconnect the mating terminals
with minimal effort. For example, the mechanism may allow an
overweight diabetic patient to reach down to his own legs or feet
and easily snap or unsnap the DED to/from the wearable device
without excessive effort.
[0017] The DED, in addition to having data recording, processing
and/or analysis capabilities, may incorporate an energy source such
as a battery providing energy for data recording, processing and/or
analysis, as well as providing energy for operation of one or more
of the sensor(s). The energy source is preferably a rechargeable
and/or replaceable battery source. The DED generally provides a
lightweight and water-tight enclosure for the data collection and
processing electronics and (optional) energy source and provides
receiving terminals that mate with the transfer terminals connected
to the sensor(s) for conveying data from the sensors to the
dedicated electronic device.
[0018] Dedicated electronic devices having signal receipt terminals
that mate with the signal transfer terminals associated with the
substrate may take a variety of form factors, depending on the form
factor of the underlying sensing substrate and/or the conditions
and location of the device during use. When sensors are
incorporated in a sock-like form factor for monitoring conditions
sensed at the foot, for example, the signal transfer terminals may
be arranged in proximity to one another in an ankle region of the
sock, and the DED may have the curved form factor of a band that
extends partially around the ankle or lower leg and attaches to the
underlying signal transfer terminals and sock substrate along a
front and/or side portion of the user's ankle or lower leg. When
sensors are incorporated in a wrap or band, the signal transfer
terminals may be arranged at or near an exposed end of the wrap or
band following its application to an underlying anatomical
structure or body surface, and the DED may be provided as a band or
a tab or a dongle-like or capsule-like device having aligned signal
receipt terminals. The DED may be provided as a substantially
flexible or a substantially rigid component, depending upon the
application, and it may take a variety of forms.
[0019] The DED preferably communicates with and transfers data to
one or more external computing and/or display system(s), such as a
smartphone, computer, tablet computer, dedicated computing device,
medical records system or the like, using wired and/or wireless
data communication means and protocols. The DED and/or an external
computing and/or display system may, in turn, communicate with a
centralized host computing system (located, e.g., in the Cloud),
where further data processing and analysis takes place.
Substantially real-time feedback, including data displays,
notifications, alerts and the like, may be provided to the user,
caretaker and/or clinician according to user, caretaker and/or
clinician preferences.
[0020] In some embodiments, the DED may store the data temporarily
to a local memory, and periodically transfer the data (e.g., in
batches) to the above mentioned external computing and/or display
system(s). Offline processing and feedback, including data
displays, notifications and the like may be provided to the user,
caretaker, and/or clinician according to user, caretaker and/or
clinician preferences.
[0021] In operation, an authentication routine and/or user
identification system matches the DED and associated sensing system
(e.g., the collection of sensor(s) associated with an underlying
substrate) with the user, caretaker and/or clinician, and may link
user information or data from other sources to a software- and/or
firmware-implemented system residing on the external computing
system. The external computing device may itself communicate with a
centralized host computing system or facility where data is stored,
processed, analyzed, and the like, and where output,
communications, instructions, commands, and the like may be
formulated for delivery back to the user, caretaker and/or
clinician through the external computing device and/or the DED.
[0022] Calibration routines may be provided to ensure that the DED
and connected related sensor system are properly configured to work
optimally for the specific user. Configuration and setup routines
may be provided to guide the user (or caretaker or medical
professional) to input user information or data to facilitate data
collection, and various protocols, routines, data analysis and/or
display characteristics, and the like, may be selected by the user
(or caretaker or medical professional) to provide data collection
and analysis that is targeted to specific users. Specific examples
are provided below. Notification and alarm systems may be provided,
and selectively enabled, to provide messages, warnings, alarms, and
the like to the user, and/or to caretakers and/or medical
providers, substantially in real-time, based on sensed data.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 shows an exemplary sensing device having a sock form
factor and having one or more sensor patches electrically connected
to one or more terminals by means of conductive pathways.
[0024] FIG. 2 shows another exemplary sensing device similar to
that shown in FIG. 1 and having a different arrangement of sensor
patches electrically connected to terminals by means of conductive
pathways.
[0025] FIG. 3 shows another view of an exemplary sensing device
similar to that shown in FIGS. 1 and 2.
[0026] FIG. 4 shows a view of terminals of the sensing device and
an exploded view of a detachable dedicated electronic device that,
when attached to terminals on the sock, captures and optionally
processes, stores and/or analyzes sensed signals or data.
[0027] FIG. 5 shows an enlarged, exploded view of an exemplary
detachable electronic device similar to that shown in FIG. 4.
[0028] FIGS. 6A and 6B show schematic illustrations of exemplary
sensors having leads provided in different configurations.
[0029] FIG. 7 shows an image illustrating a sensor of the type
illustrated in FIG. 6A mounted on a fabric substrate, with each of
the leads connected to a conductive trace.
[0030] FIG. 8 shows an image illustrating two exemplary conductive
traces mounted on an internal surface of a fabric substrate in a
sock-like form factor, terminating in conductive signal transmit
terminals that penetrate the fabric substrate.
[0031] FIG. 9 shows an image illustrating two exemplary sensors of
the type illustrated in FIG. 6A mounted on a fabric substrate, with
each of the leads connected to a conductive trace and each of the
traces terminating in a conductive signal transmit terminal.
[0032] FIG. 10 shows an image illustrating the external surface of
a fabric substrate in a sock-like form factor, showing multiple
conductive terminals for mating with terminals of an intermediate
device.
[0033] FIGS. 11A and 11B show images illustrating dedicated
electronic component for connecting to signal transmit terminals
having a curved form factor for mounting at an ankle or lower leg
portion of a user.
[0034] FIGS. 12A and 12B show a schematic diagrams illustrating one
embodiment of mating mechanical and magnetic fasteners providing a
mechanical and electrical connection between the dedicated
electronic component and the signal transmit terminals, via mating
magnetic snaps. FIG. 12A shows a schematic exploded diagram
illustrating exemplary components of the male connector; FIG. 12B
shows a schematic exploded diagram illustrating exemplary
components of the female connector.
[0035] FIG. 13 shows an image illustrating a sensor-activated
device of the type shown in FIGS. 7-10 having a sock-like form
factor in place on a user's foot, with an intermediate device
having an anklet-like form factor as shown in FIGS. 11A and 11B
connected to the external terminals for data collection and,
optionally, analysis.
[0036] FIG. 14 shows a block diagram illustrating basic components
of an exemplary data collection device and illustrating its
interface with sensors provided in a substrate, an external
computing device, and a centralized host system maintained, for
example, in the Cloud.
[0037] FIG. 15 shows an image illustrating an independently
positionable sensor mounted to conductive leads and signal transmit
terminals for placement at the discretion of a patient or care
provider.
[0038] FIG. 16A illustrates the placement of an independently
positionable sensor device of the type illustrated in FIG. 15 at a
location (e.g., on the bottom of a patient's foot or between layers
of bandages) where the patient and/or caretaker would like to
monitor conditions (e.g., pressure and/or shear), and FIG. 16B
illustrates signal transfer terminals connected to conductive
traces connected to the sensor that are positionable, for example
at the top of a patient's foot or on the exterior of a bandage, for
connection to a dedicated electronic component.
[0039] FIG. 17 shows an image illustrating one view of a sensing
system using a sensor device as illustrated in FIGS. 15-16B in
combination with a versatile wrap, with the conductive signal
transfer terminals exposed for connection to an electronic
intermediate such as a Dedicated Electronic Device (DED).
[0040] FIGS. 18A and 18B illustrate an exemplary textile sensor
employing a protective, substantially liquid impermeable barrier.
FIG. 18A shows one face of the assembled sensor system and FIG. 18B
shows the opposite face of the assembled sensor system.
[0041] FIG. 19 schematically illustrates a sensing system having
one or more sensors with leads and conductive traces terminating in
terminals in a bandage or wrap form factor.
[0042] FIG. 20 schematically illustrates a fabric-based sensing
system having multiple sensors with leads and conductive traces
terminating in signal transmit terminals for connection to an
intermediate electronic device for data collection, storage and/or
processing.
[0043] FIG. 21 schematically illustrates a patient setup protocol,
clinician dashboard and patient offloading data display for
monitoring wounds such as foot ulcers.
[0044] FIGS. 22A-22L illustrate exemplary device set ups,
calibration and monitoring criteria input and routines, along with
an exemplary clinician dashboard, a graphical representation of
patient offloading data, and an exemplary sample of acquired
pressure data. FIG. 22A shows exemplary setup and calibration
steps; FIG. 22B shows an exemplary patient data input routine; FIG.
22C shows an exemplary device setup routine; FIG. 22D shows an
exemplary device setup routine; FIG. 22E shows another exemplary
device setup routine; FIG. 22F shows another exemplary device setup
routine; FIG. 22G shows an exemplary monitoring routine setup; FIG.
22H shows another exemplary monitoring routine setup; FIG. 22I
shows an exemplary user calibration routine; FIG. 22J shows an
exemplary clinician dashboard presenting patient status information
for a plurality of patients using a sensing device of the present
invention; FIG. 22K shows an exemplary patient offloading data
display; and FIG. 22L shows exemplary pressure data collected using
an exemplary sensing system of the present invention.
[0045] FIG. 23 shows an exemplary sensing system having sensors
located in a sock, with one or more sensors electrically connected
to one or more terminals, and subsequently to a dedicated
electronic device located in a shin guard. It will be understood
that the appended drawings are not necessarily to scale, and that
they present simplified, schematic views of many aspects of systems
and components of the present invention. Specific design features,
including dimensions, orientations, locations and configurations of
various illustrated components may be modified, for example, for
use in various intended applications and environments.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
Sensors and Sensor Systems Used in a Sock-like Form Factor
[0046] In one embodiment, systems incorporating sensors, leads,
traces and terminals may be mounted to and/or incorporated in or
associated with a garment having a sock-like form factor. One
version of this embodiment is illustrated in FIGS. 1-5. In general,
a substrate material in the form of a sock may be equipped with one
or more sensors, leads, traces and connectors that provide signals
and/or data to a dedicated (and preferably detachable) electronic
device that gathers data from each sensor and communicates to an
external computer and/or mobile device. Sensors used in footwear
and sock applications typically include pressure sensors capable of
detecting levels of pressure (and/or force and/or shear) at one or
more areas of the foot and may include other types of sensors,
including temperature, accelerometers, heart rate monitors and/or
moisture sensors, and the like. Based on the detected pressure,
force and/or shear at one or more areas of the foot, and trends in
those parameters over one or more monitoring period(s), conclusions
relating to the lack of proper offloading and related conditions of
the underlying skin or tissue, healing progression (or lack of
healing), discomfort, extent and seriousness of injury, and the
like, may be drawn and may be communicated to the user, caretaker
and/or clinician, essentially in real time. In addition,
notifications, alerts, recommended actions, and the like may also
be communicated to the user, caretaker and/or clinician based on
the data analysis, essentially in real time. These systems are
suitable for use in medical and patient adherence monitoring
applications, diabetic (and other) foot monitoring, sports and
fitness applications, footwear fitting applications, military
applications, etc.
[0047] One embodiment of a sensor system embodied in a sock-like
form factor is illustrated in FIGS. 1-5. In this embodiment, a
flexible and preferably stretchable fabric substrate in the form of
a sock 1 has one or more sensors, shown as sensor patches 2,
optionally including one or more pressure sensors constructed from
flexible and conductive fabric as disclosed herein. Each of the
sensor patches 2 has leads and conductive traces or threads 3, each
terminating in a conductive signal transfer terminal 4. The sensor
patches 2 and conductive traces or threads 3 may be woven into the
fabric forming the sock, or may be applied to a surface of the
fabric forming the sock. In one embodiment, e-textile fabric
pressure sensors are applied to an internal surface of the fabric
that contacts a user's skin (directly or indirectly) when the sock
is worn. Additional fabric sensors may be used in connection with
the sock, and other types of sensors, including heat sensors (e.g.,
thermocouples), moisture sensors, and the like, may also be
incorporated in the sock with leads and traces terminating in
additional signal transfer terminals. In general, the conductive
traces may be applied to an internal or external surface of the
underlying fabric substrate, and the terminals preferably have a
conductive transfer interface accessible to the external surface of
the fabric substrate. In the embodiment illustrated in FIGS. 1-5,
the signal transfer terminals 4 are positioned in proximity to the
top of the sock, although it will be appreciated they may be
positioned elsewhere.
[0048] The signal transfer terminals 4 that connect to the
sensor(s) in the sock are connectible to mating signal receiving
terminals of a detachable electronic device (DED). Simplified
diagrams illustrating exemplary DEDs are shown in FIGS. 4 and 5.
Detachable electronic device 5 receives signals from each of the
signal transfer terminals, and thus collects data from each of the
sensors. As shown in FIG. 4, the DED may comprise mechanical
interface(s) 6 for attaching the DED to terminals 4 located on the
sock (or another sensing device); a housing component 7 protecting
internal DED components and providing signal transfer from the
sensing device (e.g., terminals on the sock) to internal DED
components; electronic and communications components 10 and
conductive terminals 9 receiving signals from terminals 4 in the
sock sensing device; a mating ring 12, and an external housing lid
13 having a power button 14 for activating the DED. An alternative,
simplified DED is shown in FIG. 5, comprising mechanical
interface(s) 6 for attaching the DED to terminals 4 located on the
sock (or another sensing device); an integrated component 15
providing a housing, electronic and communications components, and
an external housing lid 13. It will be appreciated that many other
types and styles of DEDs may be provided for interfacing with and
downloading signals and/or data from the underlying sock sensing
device.
[0049] In one embodiment, mechanically mating snaps are used as
terminal interfaces and operated as mechanical switches that are
switched on and off abruptly by an external driving force from one
switch position (attached) to a second position (detached). In
another embodiment, conductive, magnetic snap switches are used as
mating terminals for transferring signals and/or data from the sock
to the DED. FIGS. 12A and 12B show one specific design of such
snaps: an external magnetic ring may be used on the male (DED) snap
to attract and maintain solid connection with a magnetic component
of a female portion of the snap located on the underlying
substrate. In this exemplary embodiment, properties of the magnetic
field may be used to create snaps that can only connect in one
orientation: in this way, the user is guided to properly connect
the DED to the sensor system(s) associated with the underlying
substrate. Circuitry in the DED may provide the ability to
automatically turn the data collection on and off, for example,
based on the presence of the magnetic connection between the DED
and the sensor system. It will be appreciated that many other types
of mechanical and non-mechanical interfaces may be used to attach
and detach the DED from the signal transfer terminals, and to
transfer signals and/or data from the sensing system to the
DED.
[0050] Circuitry in the DED may be provided for reading the sensor
signals; firmware may be provided for processing signal data,
applying post processing algorithms and formatting the data for
communication to an external computing and/or display device. The
DED may incorporate firmware and/or software components for
collecting, filtering, processing, analyzing data, or the like. In
one embodiment, the DED hosts firmware subroutines that apply at
least some of the following: low pass filtering algorithms to
reduce incoming signal noise; pull up resistors logic to avoid
shorting of the device and additional noise filtering.
[0051] In one embodiment, the DED may be physically attached to the
sensing substrate (e.g., sock) for data collection and then
detached from the sensor terminals and physically mounted (e.g.,
though a USB or another wired connection), to an external computing
and/or display device such as a phone, personal computing device,
computer, or the like to download data. In other embodiments, the
DED preferably has wireless communication capability (e.g., using
Bluetooth, WiFi, or another wireless standard) and transmits
signals and/or data to a computing and/or display device
wirelessly. The DED is thus connected through a communication
system to an external electronic device having computing and/or
display capabilities. The external computing and/or display device
generally hosts client firmware and/or software and processing
firmware and/or software for processing, analyzing, communicating
and/or displaying data. It will be appreciated that the division of
functions and processing, such as data processing, analysis,
communications and display functions as between the DED and the
external computing and/or display device may vary depending on many
factors and is, to at least some extent, discretionary.
[0052] In some embodiments, client software and communications
systems are hosted on the external computing device (e.g., a
computer or a mobile device such as a tablet or smartphone), and
provide feedback to and interact with the user, communicating
through an Internet connection via web services, to push collected
data and retrieve processed data from the service and display (or
otherwise communicate) it to the user. The client software may
comprise a set of applications that can run on multiple platforms
(not limited to personal computers, tablets, smartphones) and
sub-components (diagnostics, troubleshooting, data collecting, snap
and match, shopping) to deliver a rich and complete user
experience. The experience can be also delivered through an
Internet browser.
[0053] For some applications, server software components that apply
crowdsourcing logic and/or machine learning technologies may be
implemented to identify, profile, and cluster user data. The data
may be stored in a database and may be continuously or
intermittently updated with incoming user supplied and/or sensor
supplied data. An optional software component that provides image
and pattern recognition capabilities may also be implemented. This
feature may allow a user to input data (e.g. images, external data
accessed from databases, etc.) without entering any text input.
[0054] While this specific example of sensor systems has been
described with reference to a sock form factor, it will be
appreciated that e-textile fabric sensors may be used with (and/or
applied to) other types of wearable garments (e.g., underwear,
t-shirts, trousers, tights, leggings, hats, gloves, bands, and the
like), and dedicated electronic devices having different
configurations may be designed to interface with a variety of
sensor systems embodied in different types of garments. The type of
sensor(s), garment(s), placement of sensor(s), user identification,
and the like, may be input during an authentication and initial
device calibration set up protocol. Another exemplary embodiment of
a sensor system using e-textile fabric sensors in a sock form
factor is shown in FIGS. 6A-13. FIG. 6A shows an exemplary fabric
sensor S with leads L1 and L2. In this example, sensor S1 comprises
a rectangular piece of e-textile conductive fabric, and conductive
leads L1 and L2 are positioned on opposite sides of sensor S1.
Conductive leads L1 and L2 are shown as integral extensions, or
pieces, of the same conductive fabric of sensor S1, but alternative
types of leads may also be used. FIG. 6B shows a similar fabric
sensor S2 having integral leads L3, L4 extending from a common side
of the sensor. It will be appreciated that although rectangular
sensors are illustrated, fabric sensors having a variety of sizes
and configurations may be provided. Conductive leads having the
same properties as the sensors may be used, or other types of
conductive leads may be employed. It will also be appreciated that
the arrangement of leads with respect to sensor(s) may vary,
depending on the properties, size and configuration of the sensor
and lead components.
[0055] E-textile fabric sensors are mounted to, or associated with,
the underlying fabric substrate (e.g., a stretchable, knit fabric)
in a variety of ways, including sewing, adhesive bonding, thermal
bonding, and the like. FIG. 7 shows an e-textile fabric sensor S1
having the configuration shown in FIG. 6A attached to the inside of
a stretchable, knit sock. Sensor leads L1 and L2 are sewn or bonded
to the underlying sock, and conductive traces T1 and T2 are mounted
and electrically connected to leads L1 and L2, as shown. In this
embodiment, conductive traces T1 and T2 are fabricated from
e-textile fabric materials having different properties from the
materials of the sensor S1 and leads L1 and L2.
[0056] The conductive traces T1, T2 terminate in conductive
terminals CT1, CT2, as shown in FIGS. 8-10. In the embodiment
illustrated, conductive terminals CT1, CT2 are provided as
conductive mechanical snaps, illustrated in FIG. 8, that penetrate
the substrate sock material from the interior to the exterior
surface of the sock. The interior of the sock having the
sensor/lead/trace/terminal arrangement is illustrated in FIG. 9.
Multiple fabric sensors may be implemented, resulting in multiple
conductive terminals communicating data collected from multiple
sensors located in different areas of the foot. It will be
appreciated that other types of sensors may be integrated in this
sock format sensing device (and in other formats of sensing
devices), and that additional conductive terminals may be provided
for transmission of signals and/or data from other types of
sensors. The exterior of the sock having signal transfer terminals
CT1, CT2 corresponding to a first sensor, and signal transfer
terminals CT3 and CT4 corresponding to a second sensor, is
illustrated in FIG. 10. In this embodiment, the signal transfer
terminals are aligned along a upper circumference of the sock,
shown in this embodiment as an anklet.
[0057] One embodiment of a signal transfer and signal receipt
terminal configuration that detachably mates, mechanically and
magnetically, is shown in FIGS. 12A and 12B. This is a mechanical
two-part snap device having mating male (FIG. 12A) and female (FIG.
12B) connector components, as shown. The male connector 20
comprises a central conductive pin element 21 surrounded by a
non-conductive ring member 22 and having a magnetic perimeter
portion 23. The female connector 25 comprises a central conductive
pin receiving element 26 and contact that is electrically connected
to the conductive area of the male connector when the connector
portions are mechanically and/or magnetically connected to one
another. Female connector 25 also comprises a non-conductive collar
27 and a magnetic collar 28 sized and configured to mate with
corresponding components of the male connector. The components
illustrated in FIGS. 12A and 12B are shown in an exploded view;
when assembled, the connector components nest to provide compact,
highly functional connectors. The polarity of magnetic components
23, 28 may be arranged to provide male and female connectors that
are connectable only when magnetically aligned in a predetermined
orientation, which may facilitate user connection of the mating
terminals. Although this exemplary mating terminal configuration is
illustrated having a round configuration, it will be appreciated
that other configurations, including oval, linear, polygonal, and
the like, may be used.
[0058] FIGS. 11A and 11B illustrate one exemplary embodiment of a
dedicated electronic device (DED) 40 having signal receipt
terminals RT1, RT2, RT3, RT4 that mate mechanically with conductive
terminals such as CT1-CT4 to provide signal and/or data transfer
from the sensor/lead/traces associated with the sock substrate to
the DED. DED 40, as illustrated in FIGS. 11A and 11B, comprises a
curved housing or case enclosing an interior space containing
processing, memory and/or communications components. In this
embodiment, DED 40 may be installed on the exterior of a sock in
the ankle or lower leg area of the user, as illustrated in FIG. 13.
DED 40 preferably provides a protective and watertight housing or
case protecting the electronic components provided within the
housing. The housing may be provided as a substantially rigid or a
substantially flexible component and a variety of DED form factors
may be provided, depending on the type and arrangement of
underlying substrate and signal transfer terminals.
[0059] The DED incorporates processing, memory and/or
communications functionalities within the housing. A schematic
diagram illustrating exemplary DED components and interfaces is
shown in FIG. 14. The DED has signal receipt terminals (shown as
"snap connectors") that feed analog input signals to appropriate
processing means, such as analog filters, A/D converters, and to a
processing component. Optional manual control input(s) and one or
more optional output display(s) may be provided in or on the DED,
as shown. Local memory may also be provided, and means for
communicating signals and/or data externally via wired or wireless
protocols may be provided, as shown. Signals and/or data is
communicated from the DED to an external computing facility or
device, such as a computer, base station, smartphone, or another
bridge device, and/or to a centralized, hosted facility in a remote
location, such as in the Cloud or at a centralized data processing
and analysis facility. Following data analysis in accordance with
predetermined and/or pre-programmed instructions, data output,
analysis, notifications, alerts, and the like are communicated from
the centralized hosted facility to the bridge device, and/or the
DED, as shown. It will be appreciated that this is one exemplary
data flow scheme, and that many other work flows may be
advantageously used in connection with sensing systems of the
present invention.
[0060] Although these specific embodiments have been illustrated
and described with reference to the wearable substrate having a
sock form factor, it will be appreciated that the sensors, leads,
traces and terminals, as well as different types of DEDs may be
adapted for use in other types of garment and non-garment
applications. Similar types of flexible e-textile sensors may be
applied to or associated with a wide variety of non-conductive
underlying flexible substrate materials, including woven and
non-woven materials, and incorporated in a variety of sensor
systems. Additional exemplary systems are described below, and are
non-limiting.
Wrap, Band and Sheet Sensor Applications
[0061] In additional applications, flexible sensors and sensor
systems of the present invention may be fabricated as independently
positionable sensor components and used in a variety of
applications. FIG. 15 schematically illustrates an independently
positionable sensor system compnsmg a flexible pressure sensor S1
electrically connected, via leads (not visible), to conductive
traces T1 and T2, which are in turn electrically connected to
conductive signal transfer terminals CT1 and CT2. The pressure
sensor S1, leads, and/or conductive traces may be mounted to or
associated with an underlying non-conductive flexible substrate to
provide mechanical integrity to and enhance the durability of the
system. It will be appreciated that this type of independent
flexible sensor system may be fabricated using a wide variety of
sensor sizes, and sensor functions, trace lengths, configurations,
underlying substrates, and the like, and that additional and
different types of sensors may be incorporated in such independent
flexible sensor systems, as described above.
[0062] One or more of these types of independently positionable
flexible sensor systems may be positioned by a user, caretaker
and/or clinician at a desired body site and anchored at the site
using bands, wraps, or other anchoring devices. FIGS. 16A and 16B
schematically illustrate the use of an independently positionable
sensor system on the surface of or within a bandage wrapped around
a foot. FIG. 16A shows the sensor S1 positioned as desired at a
location near the bottom of the foot. The sensor S1 may be anchored
to the desired sensing location, if desired, using a variety of
non-conductive anchoring means such as hook and loop and other
types of fasteners. Fastening means, such as hook and loop
fasteners, may be mounted on or associated with a surface (or
partial surface) of the sensor S1. The conductive traces T1, T2
transmit signals/data to conductive signal transfer terminals CT1,
CT2 positioned or positionable at an accessible external location,
such as at the top of the foot or at an ankle or lower leg
position, as shown in FIG. 16B, providing access for connection of
a DED and data downloading. Wraps, bands, bandages, or other
anchoring systems may be wrapped around the sensor system following
placement to secure the sensor system, and sensor, in place at the
desired sensing location and to maintain external access to the
signal transfer terminals.
[0063] FIG. 17 illustrates a foot wrap 50 having an integrated
sensor system, or employable in combination with an independently
positionable sensor system such as that illustrated in FIGS. 16A
and 16B positioned inside the wrap 50, between the interior surface
of wrap 50 and the foot (or another body surface). The sensor is
located at a desired sensing site on the foot and the conductive
signal transfer terminals CT1, CT2 are positioned outside wrap 30
at a location that is accessible to a DED. It will be appreciated
that while this type of wrap system is shown and described with
reference to a foot wrap, it may be embodied in various types of
wraps, bandages, wound and/or ulcer dressing materials and the like
having a variety of sizes, configurations, and sensing
capabilities. The location of the sensor(s) and conductive signal
transfer terminals, and the path of the conductive traces, is
highly flexible and may be adapted for sensing in many different
types of applications.
[0064] FIGS. 18A and 18B illustrate one exemplary embodiment in
which one or more protective layers or materials may be provided to
protect one or more sensor(s) and, optionally the associated leads,
and all or portions of conductive traces, from contact with
liquids, body fluids or other solutions, while preserving the core
resistive features and functions of the sensor(s). A protective
barrier may comprise a liquid impervious or substantially liquid
impervious material, such as a generally thin plastic sheet
material or a composite sheet material, that doesn't interfere with
the sensing capacity of the sensor. By "substantially" liquid
impervious we mean that liquid penetration of the material is
insubstantial enough to affect the features and functions of the
sensor(s). The protective barrier may optionally be breathable
and/or gas permeable. Many such liquid impervious barrier materials
are known. In some embodiments, a protective barrier may be
provided on one surface of the sensor; in some embodiments, a
sandwich- or envelope-type barrier that substantially seals the
sensor in a substantially liquid impermeable envelope or pouch may
be used.
[0065] In the embodiment shown in FIGS. 18A and 18B, barrier 30
comprises a thin, flexible sheet material and extends over and
around sensor S, enclosing the sensor in a liquid impervious
barrier or envelope. In the embodiment shown, surfaces or edges of
barrier 30 are sealed, forming a pouch around the perimeter of
sensor S at seal 31. An adhesive band 32 may be provided on one
face (or both faces) of the protective barrier for mounting the
sealed sensor component to an underlying surface or substrate (such
as a garment, the skin of the user, or the like). Although adhesive
band 32 is shown forming a peripheral band outside seal 31, it will
be appreciated that adhesive components, as well as other types of
mounting mechanisms, may be applied to or used in connection with
protected sensor components. In the embodiments shown in FIGS. 18A
and 18B, sensor S and leads L1 and L2 are encased within protective
barrier 30; conductive traces T1 and T2 exit barrier 30 for
attachment to conductive signal transfer terminals (not shown).
Additional material layers may be provided inside and/or outside
the barrier as shown in FIG. 18B to provide any desired
functionality.
[0066] FIG. 19 schematically illustrates flexible pressure sensors
S having conductive leads L1, L2 electrically connected to
conductive traces T1, T2 in place on a flexible bandage 35 or on a
wrap or another substrate for placement on or near wounds. The
signal transfer terminals (not shown) are located on opposite sides
of the bandages and may be connected to independently positionable
signal receiving terminals for signal transfer. This system
provides flexibility as to placement of the bandages having
different sizes and configurations on different body surfaces and
on body surfaces of different sizes and configurations, while
permitting convenient and flexible signal transfer.
[0067] FIG. 20 schematically illustrates a plurality of pressure
sensors (S1-S6) mounted to/in/on, or associated with, a substrate
sheet material 36 that's flexible and non-conductive. Each of the
sensors S1-S6 has conductive leads electrically connected to
conductive traces that terminate in signal transfer terminals
located at the edge of the substrate 36. The signal transfer
terminals are connectible to mating signal receiving terminals of
one or more DED(s), also mountable at the edge of the substrate. In
this embodiment, the DED may have a strip-like form factor for
connecting to aligned signal transfer terminals. This type of
sensor arrangement and system may be used, for example, in
connection with various types of garments, bed sheets, chair pads,
or the like, to provide data regarding pressure and/or shear at
locations where a user sits, lies, or the like.
[0068] FIG. 21 schematically illustrates exemplary computer- and/or
firmware- and/or software-implemented processes used by a medical
monitoring system of the present invention. In some embodiments,
patient setup and (optional) device authentication, program
selection and the like are provided, as well as a user and/or
clinician dashboard providing data output and analysis in
accordance with the program selection. One specific example of
output returned to the user and/or clinician is illustrated as
patient offloading data, expressed as excess pressure, which
provides information to the user and/or clinician as to pressure
conditions (and conditions of the underlying skin and tissue) at
the site of any of the pressure sensors provided in the system.
[0069] In one exemplary methodology of the present invention, a
garment having one or more sensing systems as described herein is
positioned on a user with sensor(s) positioned in proximity to a
body area desired to be monitored, or an independently positionable
sensing band, or bandage, or substrate is positioned relative to
one or more body surface areas of a user desired to be monitored. A
dedicated electronic device is mounted to/on or associated with
exposed signal transfer terminals of the sensing system and an
authentication protocol is initiated to match the garment/sensing
system to the user. The authentication protocol optionally loads
user data, profile information, and the like, to one or more hosted
systems, such as a centralized data processing and analysis
facility, a medical records facility, a caretaker system, clinician
dashboard, or the like. Sensor calibration may then be conducted
based on user specific information, conditions, and the like, and
thresholds, limits or specific ranges, monitoring protocols,
notifications, alerts, and the like may be selected by the user, a
caretaker, clinician, or by the system to apply user-specific
monitoring routines, parameters, and the like. Intermittent or
substantially continuous user monitoring may then be initiated,
with monitoring data and results provided to the user, a
centralized data processing and analysis facility, a medical
records facility, a caretaker system, clinician dashboard, and the
like. Changes and updates to monitoring protocols may be
implemented based on monitoring feedback, changes in user
condition, etc.
[0070] FIGS. 22A-22L schematically illustrate exemplary device set
up, calibration and monitoring criteria input, along with an
exemplary clinician dashboard, a graphical representation of
patient offloading data, and an exemplary sample of acquired
pressure data. Processing systems and means for executing device
set up and calibration, and for monitoring and reporting sensed
data may reside at a computing facility that is remote from the
sensing device or means and the dedicated electronic device and may
comprise computer implemented systems and methods at a host
computer system, a medical facility computer system, in a computing
environment such as the Cloud, or the like. Reports may be
displayed at the computing facility, or at any display device (e.g.
a monitor, smartphone, computer, electronic healthcare system, or
the like) that is capable of communicating with the computing
facility.
[0071] FIG. 22A schematically illustrates an exemplary setup and
calibration protocol involving a patient information setup routine,
a device information set up routine, a monitoring criteria set up
routine and a calibration routine. A variety of different routines
are available for patients having different conditions, for
different device configurations, sensor types and locations,
monitoring protocols, and the like. Various routines may be
programmed or programmable and selectable by a user and/or by
medical personnel. The routines may reside in the DED, a computing
device or another bridge device, in cloud services, or the
like.
[0072] FIG. 22B schematically illustrates an exemplary patient data
collection protocol forming part of the patient information setup.
In this example, a doctor or another medical professional can
collect and input data to associate to the specific patient/device
pair. Patient identification, patient-specific information like
weight, height, condition, physician, ulcer location and condition,
as well as procedures undergone, hospital admissions, notes, and
the like not only add information related to the specific case, but
can also be used as guidance for the device calibration procedure.
This information also provides meaningful data to use in aggregated
views of the overall patient data.
[0073] FIGS. 22C-22F schematically illustrate exemplary device
setup protocols including a sensor activation selection menu. In
this exemplary device setup routine, the system model number and
identification is provided, along with the type of data collection.
Real-time alerting and notification features may be selected.
Various sensors and sensor locations may be selected and activated,
while others may remain inactivated, as shown in FIGS. 22C and 22D.
FIG. 22D illustrates an exemplary sensor activation menu for a sock
type sensor surface, where the doctor or medical assistant can
activate specific sensors in a set of 5 available for the specific
example.
[0074] FIG. 22E illustrates an exemplary sensor activation menu for
a dressing/wrap type sensor surface, where the doctor or medical
assistant can specify which type of sensor (A, B, C in the specific
example) will be used for any specific patient. FIG. 22F
illustrates an exemplary sensor activation menu for an insole type
sensor surface, where the doctor or medical assistant can activate
specific sensors in a set of 5 available for the specific
example.
[0075] FIG. 22G schematically illustrates monitoring criteria
selection menus, including a monitoring threshold selection menu
and a notification selection and activation menu. FIG. 22H
schematically illustrates in more detail the monitor thresholds and
notification selection and activation menu. In this example, the
doctor or medical assistant can define different thresholds to
monitor before and after the first 72 hours post medical procedure
or post sensor activation.
[0076] The exemplary monitor thresholds define two levels of
severity: yellow and red. In one embodiment, the yellow threshold
can be surpassed for a limited period of time (for example 5
minutes every hour) without consequence: after this time-based
threshold has been surpassed, the system will alert the patient or
caregiver according to a notification or alert protocol. This
embodiment also allows the use and selection of a red threshold
that, if it is surpassed at any time, the system alerts the patient
or caregiver immediately. Thresholds are managed through a
hysteresis cycle, to avoid multiple alerts to be raised when the
pressure level is averaging around the threshold level. The
threshold levels can be preset by the parameters input for the
patient and based on historical data, or defined/tuned by the
doctor or medical assistant. Notifications may include vibration of
the device, e-mails sent to specific addresses, text messages sent
to specific phone numbers, robo-calls from an automated speech
system, or the like, and the notification type, frequency, etc. may
be set by the user or a medical professional as part of the
monitoring routine, as shown. In some embodiments, daily reports
may be sent to the doctor or caregiver for each patient using such
a sensor system.
[0077] FIG. 22I schematically illustrates a sample calibration
protocol for automatic set up of parameters such as filter
thresholds, signal gain, voltage-to-pressure formulae, and the
like, based on user-specific criteria. In this calibration,
background data may be collected while the user is in various
positions or doing various activities, such as sitting, standing,
walking, or the like, to collect patient-specific data so that
various parameters of the sensing system may be normalized to, or
standardized against patient-specific "normal" parameters.
[0078] FIG. 22J illustrates an exemplary clinician dashboard
displaying diabetic patient data by patient name, medical
condition, foot ulcer location and condition, medical procedural
history, monitoring sensor device and location, substantial
real-time monitoring information, and patient status based on
monitoring information. In the clinician dashboard shown, patients
are categorized in red, yellow or green status based on monitoring
information so that clinicians may contact and check on patients
having conditions categorized in the red status and avert more
serious conditions. The doctor or medical assistant can pivot the
data on different "dimensions", such as type of offloading device,
medical condition, ulcer location, etc. The doctor or medical
assistant can also filter and sort data based on the same
dimensions, to extract a view of the data aggregated for specific
area of interest, both for ease of access as well as statistical
purpose. For example, by analyzing this data as aggregate, specific
types of offloading devices, coupled with specific types of
monitoring devices used, might show a better outcome for patients
with ulcers in the metatarsal area.
[0079] FIG. 22K schematically illustrates a patient offloading data
display clearly showing excessive pressure exerted at sensing
locations in real-time and historically, and providing a history of
notifications and alerts provided. This data can be used by the
doctor or medical assistant for the purpose of analyzing in detail
the behavior of a patient, observing correlations and outcomes, as
well as to provide the basis for honest conversations with patients
about their behavior and how it affects the healing process. The
same data can also be used to send reports to the patient, with
emphasis on the good habits and positive reinforcement to improve
the adherence and help the healing process.
[0080] FIG. 22L schematically illustrates sensed force/pressure
data collected using a sensing system as described herein with
sensors located at the heelbone and at a metatarsal area, with
signals in areas A and B illustrating data collected while the user
walked 10 steps; signals in area C corresponding to the user
jumping, signals in area D corresponding to the user shifting his
weight, and signals in areas E and F illustrating data collected
while the user walks additional steps following the previous
activity. It will be appreciated that many other types of input and
output may be provided in connection with sensor systems of the
present invention, and that these diagrams are provided for
purposes of illustrating specific examples of useful input and
output and do not limit the invention in any way.
Medical and Athletic Monitoring
[0081] The specific examples of sensors and sensor systems
described herein are applicable to patients with multiple types of
foot related problems such as flat foot, injuries from accidents or
military personnel injured on the battle field or patients
suffering from peripheral neuropathy, and more specifically
diabetic neuropathic feet wherein portions of the foot may be
insensitive to pressure. The user, caretaker and/or clinician may
be alerted to lack of patient adherence to offloading guidance,
areas of excess pressure and/or shear, substantially in real-time,
to facilitate prevention of ulcer formation and to promote ulcer
and wound healing.
[0082] In one scenario, a user/patient or an athlete wears a sock
incorporating a flexible sensing system, as described. They turn on
the device using a switch on the DED and put the foot in a shoe.
The DED establishes a connection with one or more remote computing
devices or services (e.g., via USB/Wi-Fi/Bluetooth/other medium),
and pressure-related data is transferred to the remote computing
device/service, where data processing and analysis takes place.
Ranked recommendations related to patient adherence, performance
and goal achievements, injury preventions, what/if analysis may be
communicated and displayed to the patient, athlete and/or
coach/caregiver in substantially real-time, allowing the patient,
athlete and/or coach/caregiver to make changes to the patient's or
athlete's behavior or activity in response to the sensed pressure
and returned results.
[0083] In another embodiment, systems incorporating the DED and
signal receipt terminals may be mounted to and/or incorporated in
or associated with other types of intermediate dedicated electronic
devices, such as a protective device (e.g., a shin guard). One
version of this embodiment is illustrated in FIG. 23. In this
embodiment, a substrate material in the form of a sock may be
equipped with one or more sensors S1 . . . Sn, leads and traces T1
. . . Tn that provide signals and/or data to a set of terminals CT1
. . . CTn. The terminals may comprise snaps, or connectors, mounted
on the sock (male or female part) and on mating locations on a
protective device, such as a shin guard device (female or male
counterpart). The connectors on the sock may be located in areas
where the shin guard usually overlies the sock, such that the
counterpart connectors on the shin guard easily snap together and
connect not only the terminals, but the sock and the shin guard.
The shin guard can be manually positioned between the sock and the
shin of the wearer, of be inserted in a proper fabric socket
built-in the sock. In this embodiment, the shin guard is generally
fabricated from a harder outer casing material and a shock absorber
material on the inside. Electronic components of the dedicated
electronic device (DED), as described earlier, may be provided in a
core area or recess within the shin guard, well protected from
excessive impact. The DED gathers data from each sensor by means of
direct connections between its inputs/outputs and mating terminals
CT1 . . . CTn and communicates signals and/or data to an external
computing and/or bridge device, as described previously.
[0084] This type of arrangement may be used in a variety of sports
that require leg and/or foot protection (e.g. soccer, hockey,
football, etc.). Sensors may be placed in specific locations on a
sock or another item of apparel, dependent on the type of sport and
activity that is desired to be monitored. In one scenario, a soccer
team may wear a sensor equipped (instrumented) sock and the shin
guard with embedded DED to collect pressure data that can be
processed in real-time or after the fact and extract useful
statistical data for the individual and the team. For example, by
placing specific sensors on the sides of the sock (foot), a
software system receiving the data from the DED may be capable of
determining whether the pressure signal spikes coming from the
inner sensor are related to run, walk, a pass or a shot. The system
may provide statistical data such as number of passes, number of
shots, ball possession, etc. by means of data analysis and
synthesis.
Footwear Fitting
[0085] Throughout the footwear industry, there are multiple
international sizing systems and, even more importantly, a lack of
standardization in shoe sizing. Sensors and sensing systems of the
present invention may also be used to assist in footwear fitting.
When consumers buy or order footwear in a store or online, it's
difficult to assess proper fit, particularly given the large
selections available and without the ability to try on footwear in
their specific everyday scenario. Even when consumers shop in a
store and have the ability to try footwear on, the location and the
limited time and experience may not identify poorly fitting
footwear. This results in lost sales opportunities and high return
rates, which discourages consumers from making online purchases and
significantly raises sales costs for online merchants. Being able
to purchase and order footwear having confidence that it will fit
well would provide substantial benefit. In 2010 three hundred and
fifty million shoes were sold online, however about a third got
returned. E commerce has seen tremendous growth in recent years;
however, online footwear sales make up only 12% of the total
footwear market (compared to 50% for computers and 60% for books).
The reason is that consumers are less comfortable buying shoes
online since they cannot try on footwear before purchasing.
[0086] Pressure sensor(s) incorporated in a sock form factor, or
positioned as independently positionable sensors, may be used to
detect pressure on different points and areas of the foot and
identify areas of discomfort. Using databases and data analysis of
pressure sensors positioned on a user's foot, analytics may find
and display recommended fit options for shoes, insoles and/or
orthotics for specific individuals, and the individual may be
alerted in real-time as to recommended fit options. The
device-collected sensor data can be augmented with individualized
information provided directly by the user(s), such as requested
shoe type, model, or other search criteria.
[0087] In another embodiment, pressure sensors incorporated in a
sock form factor, or in independently positionable sensing systems,
may collect comfort and anatomic data as well as data relating to
humidity, temperature, and other parameters at one or more
locations on an individual's foot. The collected data may be
augmented with user provided information, such as requested shoe
type, model, and other search criteria, which may be processed to
provide output as individual-specific recommendations and
alerts.
[0088] In another embodiment, a user may take a picture of a shoe
and send the image to a computing device or service (e.g. via
e-mail). The footwear image may be processed and matched to
footwear metadata maintained in one or more database(s) to identify
potential matching footwear. A selection of related shoes,
including the matching one, may be presented to the user. The
selection may take in account comfort zones and foot anatomy of the
current user that share common features and needs, and may rank the
returned selection according to various parameters or user
preferences. In one embodiment, the DED control software collects
data from a sensor system to determine the anatomy of the foot.
Once wearer's anatomical foot data is processed and compared to
footwear data maintained in one or more databases, footwear
recommendations may be displayed to the wearer, ranked according to
projected fit, or other user preference(s). These systems, or
similar systems, may be used to find and display ranked recommended
fit options for footwear, insoles and/or orthotics.
[0089] While the present invention has been described above with
reference to the accompanying drawings in which particular
embodiments are shown and explained, it is to be understood that
persons skilled in the art may modify the embodiments described
herein without departing from the spirit and broad scope of the
invention. Accordingly, the descriptions provided above are
considered as being illustrative and exemplary of specific
structures, aspects and features within the broad scope of the
present invention and not as limiting the scope of the
invention.
* * * * *
References