U.S. patent application number 16/053055 was filed with the patent office on 2019-04-11 for wireless physiological sensor patches and systems.
The applicant listed for this patent is HMICRO, INC.. Invention is credited to JAMES C. BECK, SURENDAR MAGAR, ALI NIKNEJAD, VENKATESWARA RAO SATTIRAJU, LOUIS YUN.
Application Number | 20190104992 16/053055 |
Document ID | / |
Family ID | 39846676 |
Filed Date | 2019-04-11 |
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United States Patent
Application |
20190104992 |
Kind Code |
A1 |
MAGAR; SURENDAR ; et
al. |
April 11, 2019 |
WIRELESS PHYSIOLOGICAL SENSOR PATCHES AND SYSTEMS
Abstract
The present invention provides methods, devices, and systems for
wireless physiological sensor patches and systems which incorporate
these patches. The systems and methods utilize a structure where
the processing is distributed asymmetrically on the two or more
types of ASIC chips that are designed to work together. The
invention also relates to systems comprising two or more ASIC chips
designed for use in physiological sensing wherein the ASIC chips
are designed to work together to achieve high wireless link
reliability/security, low power dissipation, compactness, low cost
and support a variety of sensors for sensing various physiological
parameters.
Inventors: |
MAGAR; SURENDAR; (DUBLIN,
CA) ; SATTIRAJU; VENKATESWARA RAO; (UNION CITY,
CA) ; NIKNEJAD; ALI; (BERKELEY, CA) ; YUN;
LOUIS; (LOS ALTOS, CA) ; BECK; JAMES C.;
(BERKELEY, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
HMICRO, INC. |
FREMONT |
CA |
US |
|
|
Family ID: |
39846676 |
Appl. No.: |
16/053055 |
Filed: |
August 2, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15836169 |
Dec 8, 2017 |
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16053055 |
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14537736 |
Nov 10, 2014 |
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15836169 |
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12134151 |
Jun 5, 2008 |
8926509 |
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14537736 |
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60968023 |
Aug 24, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/024 20130101;
A61B 5/7232 20130101; A61B 2560/0412 20130101; A61B 2562/0219
20130101; G06F 19/3418 20130101; A61B 5/11 20130101; A61B 5/742
20130101; H04L 67/125 20130101; A61B 5/145 20130101; A61B 5/0816
20130101; G16H 40/20 20180101; A61B 5/0402 20130101; H04W 52/0235
20130101; A61B 5/091 20130101; A61B 5/0492 20130101; A61B 5/746
20130101; A61B 2560/0443 20130101; H04W 88/08 20130101; A61B 5/0006
20130101; A61B 5/053 20130101; H04W 52/0274 20130101; H04W 84/18
20130101; A61B 5/4504 20130101; A61B 5/6833 20130101; A61B 5/7405
20130101; A61B 5/0476 20130101; A61B 5/0488 20130101; A61B 5/0404
20130101; A61B 5/0478 20130101; A61B 5/0024 20130101; A61B 5/0408
20130101; A61B 5/0205 20130101; A61B 5/02438 20130101; A61B 5/02028
20130101; G16H 40/67 20180101; A61B 2560/0214 20130101; A61B 5/021
20130101; A61B 5/1112 20130101; A61B 5/14551 20130101; A61B
2560/0209 20130101; A61B 5/0022 20130101; H04L 67/04 20130101; A61B
5/087 20130101; A61B 7/00 20130101; A61B 5/14532 20130101; A61B
2562/0247 20130101; A61B 5/684 20130101; A61B 5/0024 20130101; H04W
84/18 20130101; A61B 5/0024 20130101; H04W 88/08 20130101; A61B
5/0024 20130101; H04W 52/0235 20130101; H04W 52/0274 20130101; A61B
5/0024 20130101; H04L 67/04 20130101; H04L 67/125 20130101; A61B
5/0024 20130101; G06F 19/3418 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/0492 20060101 A61B005/0492; A61B 7/00 20060101
A61B007/00; A61B 5/0478 20060101 A61B005/0478; A61B 5/0408 20060101
A61B005/0408; A61B 5/11 20060101 A61B005/11; H04L 29/08 20060101
H04L029/08; A61B 5/02 20060101 A61B005/02; A61B 5/0205 20060101
A61B005/0205; H04W 52/02 20060101 H04W052/02; A61B 5/1455 20060101
A61B005/1455; H04W 88/08 20060101 H04W088/08; H04W 84/18 20060101
H04W084/18; A61B 5/0404 20060101 A61B005/0404 |
Claims
1. An asymmetric system comprising: two or more ASIC chips wherein
the chips are designed to work together to measure physiological
signals, comprising: (a) a patch-ASIC chip adapted for
incorporation into a physiological signal monitoring patch
comprising a sensor interface, a processor coupled to the sensor
interface, a memory element coupled to the processor, a radio
coupled to the memory element that transmits data to a base-ASIC
chip, and power management circuits that coordinate power usage on
the chip; and (b) the base-ASIC chip, comprising a processor that
processes sensor data, a memory element coupled to the processor, a
radio coupled to the memory element that communicates instructions
to the patch-ASIC chip, power management circuits for coordinating
power usage on the chip, and a host interface through which the
base-ASIC chip communicates with a host device; wherein the
base-ASIC chip has more processing resources than the patch-ASIC
chip.
2. The system of claim 1 wherein the base-ASIC has a higher silicon
area than the patch-ASIC chip.
3. The system of claim 2 wherein the ratio of silicon area of the
base-ASIC chip to the patch-ASIC chip is at least about 2:1.
4. The system of claim 2 wherein the ratio of silicon area of the
base-ASIC chip to the patch-ASIC chip is at least about 4:1.
5. The system of claim 1 wherein the patch-ASIC chip comprises
low-complexity transmitters and low complexity receivers, and the
base-ASIC chip comprises high-complexity transmitters and high
complexity receivers.
6. The system of claim 5 wherein the patch-ASIC chip comprises a
UWB transmitter and a narrowband receiver, and the base-ASIC chip
comprises a narrow band transmitter and a UWB receiver.
7. The system of claim 1 wherein the patch-ASIC chip comprises a
turbo encoder, and the base-ASIC chip comprises a
turbo-decoder.
8. The system of claim 1 wherein the patch-ASIC chip communicates
through a single antenna, and the base-ASIC chip communicates
through multiple antennas.
9. The system of claim 8 wherein the base-ASIC chip further
comprises smart antenna processing.
10. The system of claim 1 wherein the base-ASIC chip, comprises
processors for analyzing the radio environment.
11. The system of claim 1 wherein the system comprises a base-ASIC
chip and multiple patch-ASIC chips.
12. A method comprising: monitoring a physiological condition using
two or more ASIC chips and a host device wherein the chips are
designed to work together to measure physiological signals
comprising: (a) receiving signals from a sensor at a patch-ASIC
chip that is incorporated into a physiological signal monitoring
patch, the patch-ASIC chip comprising a sensor interface coupled to
the sensor, a processor coupled to the sensor interface, a memory
element coupled to the processor, a radio coupled to the memory
element; (b) transmitting data signals from the radio on the
patch-ASIC chip through an antenna incorporated into the patch; (c)
receiving the data signals at a base-ASIC chip comprising an
antenna that sends the signals to a processor that processes data
signals, a memory element coupled to the processor, a radio coupled
to the memory element, and a host interface through which the
base-ASIC chip communicates with a host device; and (d)
transmitting instructions wirelessly from the base-ASIC chip to the
patch-ASIC chip; wherein the base-ASIC chip consumes more power
than the patch-ASIC chip.
13. The method of claim 12 wherein the ratio of power consumed by
the base-ASIC chip to the power consumed by the patch-ASIC chip
measured during continual data transmission is 2:1.
14. The method of claim 12 wherein the ratio of power consumed by
the base-ASIC chip to the power consumed by the patch-ASIC chip
measured during continual data transmission is 4:1.
15. A system comprising two or more ASIC chips wherein the chips
are designed to work together to measure physiological signals,
comprising: (a) a patch-ASIC chip adapted for incorporation into a
physiological signal monitoring patch comprising a sensor
interface, a processor coupled to the sensor interface, a memory
element coupled to the processor, a radio coupled to the memory
element that transmits data to a base-ASIC chip, and power
management circuits that coordinate power on the chip; and (b) the
base-ASIC chip comprising a processor that processes sensor data, a
memory element coupled to the processor, a radio coupled to the
memory element that that transmits instructions to the patch-ASIC
chip, power management circuits for coordinating power on the chip,
and a host interface through which the base-ASIC chip communicates
with a host device.
16. The system of claim 15 wherein the base-ASIC chip is
incorporated into a .mu.-Base and the patch-ASIC chip is
incorporated into a .mu.-Patch, wherein each of the .mu.-Base and
the .mu.-Patch comprise a printed circuit board and an antenna
attached to the printed circuit board for transmitting radio
signals.
17. The system of claim 15 wherein the base-ASIC chip acts as a
master device to coordinate a function of the .mu.-Patch.
18. The system of claim 17 wherein a function coordinated by the
base-ASIC chip is initialization and link set up, power management,
data packet routing, type of transmission radio, radio
transmit-power, radio receive-sensitivity, patch operational
integrity, audio tone generation, display activation, or a
combination thereof.
19. The system of claim 17 wherein the base-ASIC chip can
coordinate the bias of the RF circuitry on the patch-ASIC chip to
coordinate energy usage on the patch.
20. The system of claim 15 wherein the base-ASIC chip is
incorporated into the host device; wherein the host device
comprises a stationary, portable, or mobile device or a stationary,
portable, or mobile medical instrument.
21. The system of claim 15 wherein the base-ASIC chip is
incorporated into an adapter which plugs into the host device;
wherein the host device comprises a stationary, portable or mobile
device or a stationary, portable, or mobile medical instrument.
22. The system of claim 21 wherein the adapter comprising the
base-ASIC chip plugs into a medical instrument through a serial
interface connection.
23. The system of claim 21 wherein the adapter provides
physiological information from wireless sensors to a stationary,
portable, or mobile medical instrument that was designed for
receiving physiological information from wired sensors, wherein the
adapter allows the medical instrument to receive substantially
equivalent information from the wireless sensors.
24. The system of claim 21 wherein the adapter allows a medical
instrument which is designed to be connected to sensors by wires to
be compatible with sensors that transmit wirelessly.
25. The system of claim 16 wherein the base-ASIC chip is
incorporated into a cell phone.
26. The system of claim 15 wherein the patch-ASIC chip and the
base-ASIC chip are each part of an ASIC superset chip, wherein the
functionality of both the patch-ASIC chip and the base-ASIC chip
are contained on the ASIC superset chip, and wherein un-used
portions of the superset chip are turned off on the patch-ASIC chip
or the base-ASIC chip.
27. The system of claim 15 wherein the two or more ASIC chips can
send and/or receive both ultrawide band (UWB) radio and narrowband
radio signals.
28. The system of claim 17 wherein the base-ASIC chip can switch
the transmission mode of the patch-ASIC chip between UWB and
narrowband radio.
29. The system of claim 16 wherein the patch-ASIC chip comprises an
encoding scheme for encoding data transmission and the base-ASIC
chip comprises a decoding scheme for decoding data transmission
from the .mu.-Patch.
30. The system of claim 15 wherein the system provides security by
an encryption scheme using shared keys, wherein the device
comprising the base-ASIC chip wirelessly exchanges the shared keys
with the patch.
31. The system of claim 16 wherein the ASIC chips can avoid or
minimize interference by pseudo-random hopping of carrier
frequencies, or by data modulation with pseudo-random code
sequences.
32. The system of claim 16 wherein the system provides reliability
by forward-error correction, packet-retransmission by automatic
repeat request (ARQ), and/or smart antenna techniques.
33. The system of claim 16 wherein the .mu.-Patch comprises one
antenna and the .mu.-Base comprises 2 or more antennas.
34. The system of claim 16 wherein the .mu.-Patch performs
compression of the radio signal and the .mu.-Base performs
decompression of the radio signal.
35. The system of claim 16 wherein the .mu.-Base further comprise a
power amplifier external to the base-ASIC chip for amplifying
sensor data signal.
36. The system of claim 16 wherein the .mu.-Base can transmit at 5
times higher power than the .mu.-Patch.
37. The system of claim 15 comprising one base-ASIC chip and
multiple patch-ASIC chips.
38. The system of claim 16 wherein the .mu.-Patch uses on average
less than about 6 mW of power.
39. The system of claim 38, wherein the patch-ASIC chip can
transmit more than about 1 KB of data per day to the base-ASIC
chip.
40. The system of claim 38, wherein the patch-ASIC chip can
transmit more than about 1 KB of data per day at a range of up to
30 m to the base-ASIC chip.
41. A system comprising three or more ASIC chips wherein the chips
are designed to work together to measure physiological signals,
comprising: (a) a patch-ASIC chip adapted for incorporation into a
physiological signal monitoring patch comprising a sensor
interface, a processor coupled to the sensor interface, a memory
element coupled to the processor, a radio coupled to the memory
element that transmits sensor data to a base-ASIC chip and/or a
gate-ASIC chip, and power management circuits that coordinate power
on the chip; (b) the gate-ASIC chip comprising a processor that
processes sensor data, a memory element coupled to the processor, a
radio coupled to the processor that communicates with the
patch-ASIC chip and the base-ASIC chip, and power management
circuits that coordinate power on the chip; and (c) the base-ASIC
chip comprising a processor that processes sensor data, a memory
element coupled to the processor, a radio coupled to the memory
element that that transmits instructions to the patch-ASIC chip
and/or the gate-ASIC chip, power management circuits that
coordinate power on the chip, and a host interface through which
the base-ASIC chip communicates with a host device.
42. The system of claim 41 wherein the base-ASIC chip is
incorporated into a .mu.-Base, the patch-ASIC chip is incorporated
into a .mu.-Patch, and the gate-ASIC chip is incorporated into a
.mu.-Gate; wherein each of the .mu.-Base, .mu.-Patch, and .mu.-Gate
comprise a printed circuit board and an antenna attached to the
printed circuit board for transmitting radio signals.
43. The system of claim 41 wherein the gate-ASIC chip further
comprises a sensor interface for receiving signals from sensors,
wherein the .mu.-Gate is incorporated into a patch.
44. The system of claim 41 wherein the .mu.-Patch only transmits
UWB, and the .mu.-Gate has both a UWB and a narrowband radio.
45. The system of claim 41 wherein the base-ASIC chip acts as a
master device to coordinate a function of the .mu.-Patch or the
.mu.-Gate or both the .mu.-Patch and the .mu.-Gate.
46. The system of claim 42 wherein the base-ASIC chip can switch
the transmission mode of the .mu.-Patch and/or the .mu.-Gate
between UWB and narrowband radio.
47. The system of claim 41 wherein the base-ASIC chip is
incorporated into the host device; wherein the host device
comprises a stationary, portable, or mobile device or a stationary,
portable, or mobile medical instrument.
48. The system of claim 41 wherein the base-ASIC chip is
incorporated into an adapter which plugs into the host device;
wherein the host device comprises a stationary, portable or mobile
device or a stationary, portable, or mobile medical instrument.
49. The system of claim 41, wherein the gate-ASIC chip communicates
wirelessly with both the patch-ASIC chip and the base-ASIC
chip.
50. The system of claim 44 wherein the patch-ASIC chip and the
gate-ASIC chip are each members of an ASIC superset; and wherein
the unused portions on the patch-ASIC chip and/or the base-ASIC are
turned off.
51. The system of claim 41 wherein the patch-ASIC chip, the
gate-ASIC chip and the base-ASIC chip are each part of an ASIC
superset chip, wherein the functionality of two or more of the
patch-ASIC chip, the gate-ASIC chip and the base-ASIC chip are
contained on the ASIC superset chip, and wherein un-used portions
of the superset chip are turned off on the patch-ASIC chip, the
gate-ASIC chip, or the base-ASIC chip.
52. The system of claim 48 wherein the adapter comprising the
base-ASIC chip plugs into a medical instrument through a serial
interface connection.
53. The system of claim 48 wherein the adapter provides
physiological information from wireless sensors to a stationary,
portable, or mobile medical instrument that was designed for
receiving physiological information from wired sensors, wherein the
adapter allows the medical instrument to receive substantially
equivalent information from the wireless sensors.
54. The system of claim 48 wherein the adapter allows a medical
instrument which is designed to be connected to sensors by wires to
be compatible with sensors that transmit wirelessly.
55. A patch for measuring a physiological state comprising a
battery and an antenna each coupled to an integrated circuit
comprising a sensor interface that receives physiological signals
from a sensor, a processor coupled to the sensor interface, a
memory element coupled to the processor, a radio coupled to the
memory element, and power management circuits that coordinate power
dissipation on the chip; wherein the area of the patch multiplied
by the thickness of the patch is less than about 30 cm.sup.3; and
wherein the patch can wirelessly transmit physiological data for at
least about 2 days while monitoring a physiological signal from the
patient without changing or recharging the battery.
56. The patch of claim 55 wherein the monitoring of the
physiological signal is sampled substantially continuously.
57. The patch of claim 55 wherein the signal is sampled
substantially continuously at greater than 200 Hz.
58. The patch of claim 55, wherein the patch can wirelessly
transmit physiological data for at least about 4 days.
59. The patch of claim 55, wherein the battery provides a charge of
about 250 mA-hours or less.
60. The patch of claim 55, wherein the patch buffers data obtained
from monitoring a physiological signal then transmits the data in
bursts.
61. The patch of claim 55, wherein the patch uses on average less
than about 10 mW of power.
62. The patch of claim 55, wherein the patch can transmit more than
about 1 KB of sensor data per day at a range of up to 30 m.
63. The patch of claim 55, wherein the power management circuits
coordinate duty cycle with clock-gating with protocol-level sleep
modes.
64. The patch of claim 55, wherein the patch can measure signals in
continuous, episodic, and/or periodic modes.
65. The patch of claim 55 wherein the patch also comprises a
sensor.
66. The patch of claim 65 wherein the sensor comprises electrodes
and senses electrical signals.
67. The patch of claim 66 wherein the sensor measures EEG, EMG, or
ECG signals or combinations thereof.
68. The patch of claim 55 wherein the ASIC chip can send and/or
receive both ultra-wideband (UWB) and narrowband radio signals.
69. The patch of claim 55 wherein the patch comprises disposable
and reusable parts.
70. The patch of claim 69 wherein a sensor and/or the battery are
disposable, and substantially all of the electronics are
reusable.
71. The patch of claim 55 wherein the patch is disposable.
72. The patch of claim 55 wherein the sensor is separate from the
patch and electrically connected to the patch.
73. The patch of claim 55 wherein the sensor measures ECG, EEG,
EMG, SpO.sub.2, tissue impedance, heart rate, accelerometer, blood
glucose, PT-INR, respiration rate and airflow volume, body tissue
state, bone state, pressure, physical movement, body fluid density,
patient physical location, or audible body sounds, or a combination
thereof.
74. The patch of claim 55 wherein the patch can generate stimulus
signals that are detected by sensors connected to or incorporated
into the patch or connected to or incorporated into another
patch.
75. The patch of claim 74 wherein the stimulus signals are
electrical, ultrasound, or radio wave signals.
76. The patch of claim 75 wherein the electrical signals are used
to measure skin or body impedance.
77. The patch of claim 55 wherein the patch comprises an alert
which is an audio signal generator or a visual display.
78. The patch of claim 55 wherein the battery can be re-charged via
electromagnetic induction.
79. A patch for measuring a physiological state comprising a
battery and an antenna each coupled to an integrated circuit
comprising a sensor interface that receives physiological signals
from a sensor, a processor coupled to the sensor interface, a
memory element coupled to the processor, a radio coupled to the
memory element, and power management circuits that coordinate power
dissipation on the chip; wherein the patch is a cardiac patch that
can measure all of ECG, SpO.sub.2, tissue impedance, accelerometer,
and PT-INR signals.
80. A patch for measuring a physiological state comprising a
battery and an antenna each coupled to an integrated circuit
comprising a sensor interface that receives physiological signals
from a sensor, a processor coupled to the sensor interface, a
memory element coupled to the processor, a radio coupled to the
memory element, and power management circuits that coordinate power
dissipation on the chip; wherein the patch is a neurological patch
for measuring sleep apnea that can measure all of EEG, EMG,
SpO.sub.2, heart rate, respiration rate and airflow volume, and
pressure signals.
81. A patch for measuring a physiological state comprising a
battery and an antenna each coupled to an integrated circuit
comprising a sensor interface that receives physiological signals
from a sensor, a processor coupled to the sensor interface, a
memory element coupled to the processor, a radio coupled to the
memory element, and power management circuits that coordinate power
dissipation on the chip; wherein the patch is an endocrinological
patch for measuring diabetes or wounds that can measure all of ECG,
blood glucose, and UWB radar signals.
82. A patch for measuring a physiological state comprising a
battery and an antenna each coupled to an integrated circuit
comprising a sensor interface that receives physiological signals
from a sensor, a processor coupled to the sensor interface, a
memory element coupled to the processor, a radio coupled to the
memory element, and power management circuits that coordinate power
dissipation on the chip; wherein the patch is fitness and wellness
patch that can measure all of ECG, heart rate, accelerometer, and
pressure signals.
83. A method comprising monitoring a physiological condition using
two or more ASIC chips and a host device wherein the chips are
designed to work together to measure physiological signals
comprising: (a) receiving signals from a sensor at a patch-ASIC
chip that is incorporated into a physiological signal monitoring
patch, the patch-ASIC chip comprising a sensor interface coupled to
the sensor, a processor coupled to the sensor interface, a memory
element coupled to the processor, a radio coupled to the memory
element; (b) managing the power dissipation on the patch-ASIC chip
with power management circuits on the patch-ASIC chip; (c)
transmitting data signals from the radio on the patch-ASIC chip
through an antenna incorporated into the patch; (d) receiving the
data signals at a base-ASIC chip comprising a processor that
processes data signals, a memory element coupled to the processor,
a radio coupled to the memory element, power management circuits
that coordinate power dissipation on the base-ASIC chip, and a host
interface through which the base-ASIC chip communicates with a host
device; and (e) sending instructions wirelessly from the base-ASIC
chip to the patch-ASIC chip such that the base-ASIC chip
coordinates a function of the physiological signal monitoring
patch.
84. The method of claim 83 wherein a function coordinated by the
base-ASIC chip is initialization and link set up, power management,
data packet routing, type of transmission radio, radio
transmit-power, radio receive-sensitivity, patch operational
integrity, audio signal generation, display activation, or a
combination thereof.
85. The method of claim 83 wherein the ASIC chips function on a
packet-data protocol and the base-ASIC chip coordinates data packet
routing.
86. The method of claim 83 wherein the base-ASIC chip keeps track
of the quality of the wireless links between ASIC chips and sends
commands to the patch-ASIC chip and/or gate-ASIC chips to instruct
the chips to switch between UWB and narrowband radio or to raise or
lower transmit power in order to lower power consumption or to
enhance communication quality.
87. The method of claim 83 wherein the patch-ASIC chip is
authenticated by bringing the physiological monitoring patch in
proximity of the device comprising the base-ASIC chip.
88. The system of claim 87 wherein the authentication is provided
by an encryption scheme using shared keys, wherein the device
comprising the base-ASIC chip wirelessly exchanges the shared keys
with the patch.
89. The system of claim 88 wherein the encryption scheme is an
Advanced Encryption Standard (AES) scheme.
90. The method of claim 83 wherein a user is alerted with an audio
and/or a visual signal.
91. The method of claim 90 wherein the audio and/or visual signal
is generated on the patch.
92. The method of claim 90 wherein the audio and/or visual signal
is generated on a device to which the base-ASIC chip is
connected.
93. The method of claim 83 wherein the method is used to manage a
patient disease.
94. The method of claim 93 wherein the patient disease is
arrhythmia, heart failure, coronary heart disease, diabetes, sleep
apnea, seizures, asthma, COPD, pregnancy complications, and wound
state or combinations thereof.
95. The method of claim 83 wherein the method is used to manage a
condition related to the state of wellness and fitness of a
person.
96. The method of claim 95 wherein the condition being managed is
weight loss, obesity, heart rate, cardiac performance, dehydration
rate, blood glucose, physical activity or calorie intake, or
combinations thereof.
97. A method comprising monitoring a physiological condition using
three or more ASIC chips wherein the chips are designed to work
together to measure physiological signals, comprising: (a)
receiving physiological signals from sensors at a patch-ASIC chip
incorporated into a physiological signal monitoring patch, the
patch-ASIC chip comprising a sensor interface, a processor coupled
to the sensor interface, a memory element coupled to the processor,
a radio coupled to the memory element; (b) managing power
dissipation on the patch-ASIC chip with power management circuits
on the patch-ASIC chip; (c) transmitting data to a base-ASIC and/or
a gate-ASIC chip through an antenna in the patch; (d) receiving the
data sent from the patch-ASIC chip at the gate-ASIC chip, the
gate-ASIC chip comprising a processor that processes sensor data, a
memory element coupled to the processor, a radio coupled to the
processor that communicates with the patch-ASIC chip and the
base-ASIC chip, and power management circuits for coordinating
power dissipation on the gate-ASIC chip; (e) coordinating a
function on the patch-ASIC chip and/or gate-ASIC chip by sending
instructions from a base-ASIC chip to the patch-ASIC chip and/or
the gate-ASIC chip, wherein the base-ASIC chip comprises a
processor that processes sensor data, a memory element coupled to
the processor, a radio coupled to the memory element, power
management circuits for coordinating power dissipation on the
base-ASIC chip; and (f) sending data from the base-ASIC chip to a
host device through a host interface.
98. The method of claim 97 wherein the base-ASIC chip is
incorporated into a .mu.-Base, the patch-ASIC chip is incorporated
into a .mu.-Patch, and the gate-ASIC chip is incorporated into a
.mu.-Gate; wherein each of the .mu.-Base, .mu.-Patch, and .mu.-Gate
comprise a printed circuit board and an antenna attached to the
printed circuit board for transmitting and receiving radio
signals.
99. The method of claim 97 wherein the gate-ASIC chip further
comprises a sensor interface for receiving signals from sensors,
wherein the gate-ASIC is incorporated into a patch.
100. The method of claim 98 wherein the .mu.-Patch only transmits
UWB, and the .mu.-Gate comprises both UWB and narrowband
radios.
101. The method of claim 98 wherein the base-ASIC chip acts as a
master device to coordinate a function of the .mu.-Patch or the
.mu.-Gate or both the .mu.-Patch and the .mu.-Gate.
102. The method of claim 98 wherein the base-ASIC chip keeps track
of the quality of the wireless links between ASIC chips and sends
commands to the patch-ASIC chip and/or gate-ASIC chips to instruct
the chips to switch between UWB and narrowband radio or to raise or
lower transmit power in order to lower power consumption or to
enhance communication quality.
103. The method of claim 98 wherein the base-ASIC chip is
incorporated into the host device; wherein the host device
comprises a stationary, portable, or mobile device or a stationary,
portable, or mobile medical instrument.
104. The method of claim 98 wherein the base-ASIC chip is
incorporated into an adapter which plugs into the host device;
wherein the host device comprises a stationary, portable or mobile
device or a stationary, portable, or mobile medical instrument.
105. The method of claim 97, wherein the gate-ASIC chip
communicates wirelessly with both the patch-ASIC chip and the
base-ASIC chip.
106. The method of claim 100 wherein the patch-ASIC chip and the
gate-ASIC chip are each members of an ASIC superset; and wherein an
unused function on the patch-ASIC chip is turned off.
107. The method of claim 97 wherein the patch-ASIC chip, the
gate-ASIC chip and the base-ASIC chip are each part of an ASIC
superset chip, wherein the functionality of two or more of the
patch-ASIC chip, the gate-ASIC chip and the base-ASIC chip are
contained on the ASIC superset chip, and wherein un-used portions
of the superset chip are turned off on the patch-ASIC chip, the
gate-ASIC chip, or the base-ASIC chip.
108. The method of claim 104 wherein the adapter comprising the
base-ASIC chip plugs into a medical instrument through a serial
interface connection.
109. The method of claim 104 wherein the adapter provides
physiological information from wireless sensors to a stationary,
portable, or mobile medical instrument that was designed for
receiving physiological information from wired sensors, wherein the
adapter allows the medical instrument to receive substantially
equivalent information from the wireless sensors.
110. The method of claim 104 wherein the adapter allows a medical
instrument which is designed to be connected to sensors by wires to
be compatible with sensors that transmit wirelessly.
111. A method comprising receiving physiological signals from
sensors at a patch wherein the patch comprises a battery and an
antenna each coupled to an integrated circuit comprising a sensor
interface that receives the physiological signals from the sensor,
a processor coupled to the sensor interface that receives signals
from the sensor interface and processes the signals, a memory
element coupled to the processor that receives and stores signals,
and a radio coupled to the memory element that sends signals
received from the memory element to an antenna, wherein power
management circuits coordinate power dissipation on the chip;
wherein the area of the patch multiplied by the thickness of the
patch is less than about 30 cm.sup.3; and wherein the patch can
wirelessly transmit physiological data for at least about 2 days
while monitoring a physiological signal from the patient without
changing or recharging the battery.
112. The method of claim 111 wherein the monitoring of the
physiological signal is sampled substantially continuously.
113. The method of claim 111 wherein the signal is sampled
substantially continuously at greater than 200 Hz.
114. The method of claim 111, wherein the method can wirelessly
transmit physiological data for at least about 4 days.
115. The method of claim 111, wherein the battery provides a charge
of about 250 mA-hours or less.
116. The method of claim 111, wherein the patch buffers data
obtained from monitoring a physiological signal then transmits the
data in bursts.
117. The method of claim 111, wherein the patch uses on average
less than about 10 mW of power.
118. The method of claim 111, wherein the patch can transmit more
than about 1 KB of sensor data per day at a range of up to 30
m.
119. The method of claim 111, wherein the power management circuits
coordinate duty cycle with clock-gating with protocol-level sleep
modes.
120. The method of claim 111, wherein the patch can measure signals
in continuous, episodic, and/or periodic modes.
121. The method of claim 111 wherein the patch also comprises the
sensor.
122. The method of claim 121 wherein the sensor comprises
electrodes and senses electrical signals.
123. The method of claim 122 wherein the sensor measures EEG, EMG
and ECG signals or combinations thereof.
124. The method of claim 111 wherein the ASIC chip can send and/or
receive both ultra-wideband (UWB) and narrowband radio signals.
125. The method of claim 111 wherein the patch comprises disposable
and reusable parts.
126. The method of claim 125 wherein a sensor and/or the battery
are disposable, and substantially all of the electronics are
reusable.
127. The method of claim 111 wherein the patch is disposable.
128. The method of claim 111 wherein the sensor is separate from
the patch and electrically connected to the patch.
129. The method of claim 111 wherein the sensor measures ECG, EEG,
EMG, SpO.sub.2, tissue impedance, heart rate, accelerometer, blood
glucose, PT-INR, respiration rate and airflow volume, body state,
bone state, pressure, physical movement, body fluid density,
patient physical location, or audible body sounds, or a combination
thereof.
130. The method of claim 111 wherein the method can generate
stimulus signals that are detected by sensors connected to or
incorporated into the patch or connected to or incorporated into
another patch.
131. The method of claim 130 wherein the stimulus signals are
electrical, ultrasound, or radio wave signals.
132. The method of claim 131 wherein the electrical signals are
used to measure skin or body impedance.
133. The method of claim 111 wherein the patch comprises an alert
which is an audio signal generator or a visual display.
134. The method of claim 111 wherein the battery can be re-charged
magnetically.
135. The method of claim 111 wherein the patch is a cardiac patch
that can measure all of ECG, SpO.sub.2, tissue impedance,
accelerometer, and PT-INR signals.
136. The method of claim 111 wherein the patch is a neurological
patch for measuring sleep apnea that can measure all of EEG, EMG,
SpO.sub.2, heart rate, respiration rate and airflow volume, and
pressure signals.
137. The method of claim 111 wherein the patch is an
endocrinological patch for measuring diabetes or wounds that can
measure all of ECG, blood glucose, and UWB radar signals.
138. The method of claim 111 wherein the patch is fitness and
wellness patch that can measure all of ECG, heart rate,
accelerometer, and pressure signals.
139. A method for unsupervised placement of a physiological patch
comprising: (a) placing the patch that can receive wireless signals
from a base device, wherein the patch comprises a visual marker to
help the user orient the patch on the patient's body; (b)
initializing the patch with a base device by automatic verification
of proper placement of the patch; and (c) indicating the proper or
improper placement of the patch to the user with an audio or visual
indication.
140. A business method comprising: (a) manufacturing both a
patch-ASIC chip and a base-ASIC chip designed to work together to
wirelessly communicate physiological data, wherein each chip each
comprises a processor, memory storage, a wireless radio, and
circuits for power management, wherein the chips are designed to be
used with a plurality sensor types; and (b) selling and/or
licensing the patch-ASIC chip and base-ASIC chip to multiple
customers for incorporation into physiological sensing systems.
141. The business method of claim 140 wherein the plurality of
sensor types include sensors that measure all of ECG, EEG, EMG,
SpO.sub.2, tissue impedance, heart rate, and accelerometer
signals.
142. The business method of claim 140 further comprising a
gate-ASIC chip designed to work together with the patch-ASIC chip
and the base-ASIC chip, to wirelessly communicate physiological
data, wherein each chip each comprises a processor, memory storage,
a wireless radio, and circuits for power management, wherein the
chips are designed to be used with a plurality sensor types.
Description
CROSS-REFERENCE
[0001] This application is a continuation application of U.S.
application Ser. No. 15/836,169, filed Dec. 8, 2017, which is a
continuation application of U.S. application Ser. No. 14/537,736,
filed Nov. 10, 2014, which is a continuation application of U.S.
application Ser. No. 12/134,151, filed on Jun. 5, 2008, which
claims the benefit of U.S. Provisional Application Ser. No.
60/968,023, filed Aug. 24, 2007, which applications are
incorporated herein by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] Monitoring the health of people has always been important.
As the population ages and more people advance in age, health
monitoring systems become more significant to maintaining a healthy
lifestyle and disease management. Remote health monitoring makes it
easier and cost effective to monitor the health of vast
populations. Wireless systems are the most desired approach to
enable remote health monitoring. Therefore, a variety of wireless
health monitoring systems have been introduced over the years.
[0003] Conventional wireless health monitoring systems are bulky,
expensive, have inadequate wireless link reliability and have high
power dissipation which severely limits their applications,
particularly to monitor wide ranging physiological parameters in
high volumes for large populations. Accordingly, what is desired is
a system that addresses the above-identified issues.
SUMMARY OF THE INVENTION
[0004] One aspect of the invention is an asymmetric system
comprising: two or more ASIC chips wherein the chips are designed
to work together to measure physiological signals, comprising: (a)
a patch-ASIC chip adapted for incorporation into a physiological
signal monitoring patch comprising a sensor interface, a processor
coupled to the sensor interface, a memory element coupled to the
processor, a radio coupled to the memory element that transmits
data to a base-ASIC chip, and power management circuits that
coordinate power usage on the chip; and (b) the base-ASIC chip,
comprising a processor that processes sensor data, a memory element
coupled to the processor, a radio coupled to the memory element
that communicates instructions to the patch-ASIC chip, power
management circuits for coordinating power usage on the chip, and a
host interface through which the base-ASIC chip communicates with a
host device;
[0005] In some embodiments the base-ASIC chip has more processing
resources than the patch-ASIC chip.
[0006] In some embodiments the base-ASIC has a higher silicon area
than the patch-ASIC chip. In some embodiments the ratio of silicon
area of the base-ASIC chip to the patch-ASIC chip is at least about
2:1. In some embodiments the ratio of silicon area of the base-ASIC
chip to the patch-ASIC chip is at least about 4:1.
[0007] In some embodiments the patch-ASIC chip comprises
low-complexity transmitters and low complexity receivers, and the
base-ASIC chip comprises high-complexity transmitters and high
complexity receivers.
[0008] In some embodiments the patch-ASIC chip comprises a UWB
transmitter and a narrowband receiver, and the base-ASIC chip
comprises a narrow band transmitter and a UWB receiver.
[0009] In some embodiments the patch-ASIC chip comprises a turbo
encoder, and the base-ASIC chip comprises a turbo-decoder. In some
embodiments the patch-ASIC chip communicates through a single
antenna, and the base-ASIC chip communicates through multiple
antennas. In some embodiments the base-ASIC chip further comprises
smart antenna processing. In some embodiments the base-ASIC chip,
comprises processors for analyzing the radio environment. In some
embodiments the system comprises a base-ASIC chip and multiple
patch-ASIC chips.
[0010] One aspect of the invention is a method comprising:
monitoring a physiological condition using two or more ASIC chips
and a host device wherein the chips are designed to work together
to measure physiological signals comprising: (a) receiving signals
from a sensor at a patch-ASIC chip that is incorporated into a
physiological signal monitoring patch, the patch-ASIC chip
comprising a sensor interface coupled to the sensor, a processor
coupled to the sensor interface, a memory element coupled to the
processor, a radio coupled to the memory element; (b) transmitting
data signals from the radio on the patch-ASIC chip through an
antenna incorporated into the patch; (c) receiving the data signals
at a base-ASIC chip comprising an antenna that sends the signals to
a processor that processes data signals, a memory element coupled
to the processor, a radio coupled to the memory element, and a host
interface through which the base-ASIC chip communicates with a host
device; and (d) transmitting instructions wirelessly from the
base-ASIC chip to the patch-ASIC chip; wherein the base-ASIC chip
consumes more power than the patch-ASIC chip.
[0011] In some embodiments the ratio of power consumed by the
base-ASIC chip to the power consumed by the patch-ASIC chip
measured during continual data transmission is 2:1. In some
embodiments the ratio of power consumed by the base-ASIC chip to
the power consumed by the patch-ASIC chip measured during continual
data transmission is 4:1.
[0012] One aspect of the invention is a system comprising two or
more ASIC chips wherein the chips are designed to work together to
measure physiological signals, comprising: (a) a patch-ASIC chip
adapted for incorporation into a physiological signal monitoring
patch comprising a sensor interface, a processor coupled to the
sensor interface, a memory element coupled to the processor, a
radio coupled to the memory element that transmits data to a
base-ASIC chip, and power management circuits that coordinate power
on the chip; and (b) the base-ASIC chip comprising a processor that
processes sensor data, a memory element coupled to the processor, a
radio coupled to the memory element that that transmits
instructions to the patch-ASIC chip, power management circuits for
coordinating power on the chip, and a host interface through which
the base-ASIC chip communicates with a host device.
[0013] In some embodiments the base-ASIC chip is incorporated into
a .mu.-Base and the patch-ASIC chip is incorporated into a
.mu.-Patch, wherein each of the .mu.-Base and the .mu.-Patch
comprise a printed circuit board and an antenna attached to the
printed circuit board for transmitting radio signals. In some
embodiments the base-ASIC chip acts as a master device to
coordinate a function of the .mu.-Patch. In some embodiments a
function coordinated by the base-ASIC chip is initialization and
link set up, power management, data packet routing, type of
transmission radio, radio transmit-power, radio
receive-sensitivity, patch operational integrity, audio tone
generation, display activation, or a combination thereof. In some
embodiments the base-ASIC chip can coordinate the bias of the RF
circuitry on the patch-ASIC chip to coordinate energy usage on the
patch.
[0014] In some embodiments the base-ASIC chip is incorporated into
the host device; wherein the host device comprises a stationary,
portable, or mobile device or a stationary, portable, or mobile
medical instrument. In some embodiments the base-ASIC chip is
incorporated into an adapter which plugs into the host device;
wherein the host device comprises a stationary, portable or mobile
device or a stationary, portable, or mobile medical instrument. In
some embodiments the adapter comprising the base-ASIC chip plugs
into a medical instrument through a serial interface connection. In
some embodiments the adapter provides physiological information
from wireless sensors to a stationary, portable, or mobile medical
instrument that was designed for receiving physiological
information from wired sensors, wherein the adapter allows the
medical instrument to receive substantially equivalent information
from the wireless sensors. In some embodiments the adapter allows a
medical instrument which is designed to be connected to sensors by
wires to be compatible with sensors that transmit wirelessly. In
some embodiments the base-ASIC chip is incorporated into a cell
phone.
[0015] In some embodiments the patch-ASIC chip and the base-ASIC
chip are each part of an ASIC superset chip, wherein the
functionality of both the patch-ASIC chip and the base-ASIC chip
are contained on the ASIC superset chip, and wherein un-used
portions of the superset chip are turned off on the patch-ASIC chip
or the base-ASIC chip.
[0016] In some embodiments the two or more ASIC chips can send
and/or receive both ultrawide band (UWB) radio and narrowband radio
signals. In some embodiments the base-ASIC chip can switch the
transmission mode of the patch-ASIC chip between UWB and narrowband
radio. In some embodiments the patch-ASIC chip comprises an
encoding scheme for encoding data transmission and the base-ASIC
chip comprises a decoding scheme for decoding data transmission
from the .mu.-Patch. In some embodiments the system provides
security by an encryption scheme using shared keys, wherein the
device comprising the base-ASIC chip wirelessly exchanges the
shared keys with the patch. In some embodiments the ASIC chips can
avoid or minimize interference by pseudo-random hopping of carrier
frequencies, or by data modulation with pseudo-random code
sequences. In some embodiments the system provides reliability by
forward-error correction, packet-retransmission by automatic repeat
request (ARQ), and/or smart antenna techniques.
[0017] In some embodiments the .mu.-Patch comprises one antenna and
the .mu.-Base comprises 2 or more antennas. In some embodiments the
.mu.-Patch performs compression of the radio signal and the
.mu.-Base performs decompression of the radio signal.
[0018] In some embodiments the .mu.-Base further comprise a power
amplifier external to the base-ASIC chip for amplifying sensor data
signal. In some embodiments the .mu.-Base can transmit at 5 times
higher power than the .mu.-Patch.
[0019] In some embodiments the system comprises one base-ASIC chip
and multiple patch-ASIC chips.
[0020] In some embodiments the .mu.-Patch uses on average less than
about 6 mW of power. In some embodiments the patch-ASIC chip can
transmit more than about 1 KB of data per day to the base-ASIC
chip. In some embodiments the patch-ASIC chip can transmit more
than about 1 KB of data per day at a range of up to 30 m to the
base-ASIC chip.
[0021] One aspect of the invention is a system comprising three or
more ASIC chips wherein the chips are designed to work together to
measure physiological signals, comprising: (a) a patch-ASIC chip
adapted for incorporation into a physiological signal monitoring
patch comprising a sensor interface, a processor coupled to the
sensor interface, a memory element coupled to the processor, a
radio coupled to the memory element that transmits sensor data to a
base-ASIC chip and/or a gate-ASIC chip, and power management
circuits that coordinate power on the chip; (b) the gate-ASIC chip
comprising a processor that processes sensor data, a memory element
coupled to the processor, a radio coupled to the processor that
communicates with the patch-ASIC chip and the base-ASIC chip, and
power management circuits that coordinate power on the chip; and
(c) the base-ASIC chip comprising a processor that processes sensor
data, a memory element coupled to the processor, a radio coupled to
the memory element that that transmits instructions to the
patch-ASIC chip and/or the gate-ASIC chip, power management
circuits that coordinate power on the chip, and a host interface
through which the base-ASIC chip communicates with a host
device.
[0022] In some embodiments the base-ASIC chip is incorporated into
a .mu.-Base, the patch-ASIC chip is incorporated into a .mu.-Patch,
and the gate-ASIC chip is incorporated into a .mu.-Gate; wherein
each of the .mu.-Base, .mu.-Patch, and .mu.-Gate comprise a printed
circuit board and an antenna attached to the printed circuit board
for transmitting radio signals.
[0023] In some embodiments the gate-ASIC chip further comprises a
sensor interface for receiving signals from sensors, wherein the
.mu.-Gate is incorporated into a patch. In some embodiments the
.mu.-Patch only transmits UWB, and the .mu.-Gate has both a UWB and
a narrowband radio. In some embodiments the base-ASIC chip acts as
a master device to coordinate a function of the .mu.-Patch or the
.mu.-Gate or both the .mu.-Patch and the .mu.-Gate. In some
embodiments the base-ASIC chip can switch the transmission mode of
the .mu.-Patch and/or the .mu.-Gate between UWB and narrowband
radio.
[0024] In some embodiments the base-ASIC chip is incorporated into
the host device; wherein the host device comprises a stationary,
portable, or mobile device or a stationary, portable, or mobile
medical instrument. In some embodiments the base-ASIC chip is
incorporated into an adapter which plugs into the host device;
wherein the host device comprises a stationary, portable or mobile
device or a stationary, portable, or mobile medical instrument.
[0025] In some embodiments the gate-ASIC chip communicates
wirelessly with both the patch-ASIC chip and the base-ASIC
chip.
[0026] In some embodiments the patch-ASIC chip and the gate-ASIC
chip are each members of an ASIC superset; and wherein the unused
portions on the patch-ASIC chip and/or the base-ASIC are turned
off. In some embodiments the patch-ASIC chip, the gate-ASIC chip
and the base-ASIC chip are each part of an ASIC superset chip,
wherein the functionality of two or more of the patch-ASIC chip,
the gate-ASIC chip and the base-ASIC chip are contained on the ASIC
superset chip, and wherein un-used portions of the superset chip
are turned off on the patch-ASIC chip, the gate-ASIC chip, or the
base-ASIC chip. In some embodiments the adapter comprising the
base-ASIC chip plugs into a medical instrument through a serial
interface connection. In some embodiments adapter provides
physiological information from wireless sensors to a stationary,
portable, or mobile medical instrument that was designed for
receiving physiological information from wired sensors, wherein the
adapter allows the medical instrument to receive substantially
equivalent information from the wireless sensors. In some
embodiments the adapter allows a medical instrument which is
designed to be connected to sensors by wires to be compatible with
sensors that transmit wirelessly.
[0027] One aspect of the invention is a patch for measuring a
physiological state comprising a battery and an antenna each
coupled to an integrated circuit comprising a sensor interface that
receives physiological signals from a sensor, a processor coupled
to the sensor interface, a memory element coupled to the processor,
a radio coupled to the memory element, and power management
circuits that coordinate power dissipation on the chip; wherein the
area of the patch multiplied by the thickness of the patch is less
than about 30 cm.sup.3; and wherein the patch can wirelessly
transmit physiological data for at least about 2 days while
monitoring a physiological signal from the patient without changing
or recharging the battery.
[0028] In some embodiments the monitoring of the physiological
signal is sampled substantially continuously. In some embodiments
the signal is sampled substantially continuously at greater than
200 Hz. In some embodiments the patch can wirelessly transmit
physiological data for at least about 4 days. In some embodiments
the battery provides a charge of about 250 mA-hours or less.
[0029] In some embodiments the patch buffers data obtained from
monitoring a physiological signal then transmits the data in
bursts. In some embodiments the patch uses on average less than
about 10 mW of power.
[0030] In some embodiments the patch can transmit more than about 1
KB of sensor data per day at a range of up to 30 m. In some
embodiments the power management circuits coordinate duty cycle
with clock-gating with protocol-level sleep modes. In some
embodiments the patch can measure signals in continuous, episodic,
and/or periodic modes.
[0031] In some embodiments the patch also comprises a sensor. In
some embodiments the sensor comprises electrodes and senses
electrical signals. In some embodiments the sensor measures EEG,
EMG, or ECG signals or combinations thereof.
[0032] In some embodiments the ASIC chip can send and/or receive
both ultra-wideband (UWB) and narrowband radio signals.
[0033] In some embodiments the patch comprises disposable and
reusable parts. In some embodiments a sensor and/or the battery are
disposable, and substantially all of the electronics are reusable.
In some embodiments the patch is disposable.
[0034] In some embodiments the sensor is separate from the patch
and electrically connected to the patch.
[0035] In some embodiments the sensor measures ECG, EEG, EMG, SpO2,
tissue impedance, heart rate, accelerometer, blood glucose, PT-INR,
respiration rate and airflow volume, body tissue state, bone state,
pressure, physical movement, body fluid density, patient physical
location, or audible body sounds, or a combination thereof. In some
embodiments the patch can generate stimulus signals that are
detected by sensors connected to or incorporated into the patch or
connected to or incorporated into another patch. In some
embodiments the stimulus signals are electrical, ultrasound, or
radio wave signals. In some embodiments the electrical signals are
used to measure skin or body impedance.
[0036] In some embodiments the patch comprises an alert which is an
audio signal generator or a visual display. In some embodiments the
battery can be re-charged via electromagnetic induction.
[0037] One aspect of the invention is a patch for measuring a
physiological state comprising a battery and an antenna each
coupled to an integrated circuit comprising a sensor interface that
receives physiological signals from a sensor, a processor coupled
to the sensor interface, a memory element coupled to the processor,
a radio coupled to the memory element, and power management
circuits that coordinate power dissipation on the chip; wherein the
patch is a cardiac patch that can measure all of ECG, SpO2, tissue
impedance, accelerometer, and PT-INR signals.
[0038] One aspect of the invention is a patch for measuring a
physiological state comprising a battery and an antenna each
coupled to an integrated circuit comprising a sensor interface that
receives physiological signals from a sensor, a processor coupled
to the sensor interface, a memory element coupled to the processor,
a radio coupled to the memory element, and power management
circuits that coordinate power dissipation on the chip; wherein the
patch is a neurological patch for measuring sleep apnea that can
measure all of EEG, EMG, SpO2, heart rate, respiration rate and
airflow volume, and pressure signals.
[0039] One aspect of the invention is a patch for measuring a
physiological state comprising a battery and an antenna each
coupled to an integrated circuit comprising a sensor interface that
receives physiological signals from a sensor, a processor coupled
to the sensor interface, a memory element coupled to the processor,
a radio coupled to the memory element, and power management
circuits that coordinate power dissipation on the chip; wherein the
patch is an endocrinological patch for measuring diabetes or wounds
that can measure all of ECG, blood glucose, and UWB radar
signals.
[0040] One aspect of the invention is a patch for measuring a
physiological state comprising a battery and an antenna each
coupled to an integrated circuit comprising a sensor interface that
receives physiological signals from a sensor, a processor coupled
to the sensor interface, a memory element coupled to the processor,
a radio coupled to the memory element, and power management
circuits that coordinate power dissipation on the chip; wherein the
patch is fitness and wellness patch that can measure all of ECG,
heart rate, accelerometer, and pressure signals.
[0041] One aspect of the invention is a method comprising
monitoring a physiological condition using two or more ASIC chips
and a host device wherein the chips are designed to work together
to measure physiological signals comprising: (a) receiving signals
from a sensor at a patch-ASIC chip that is incorporated into a
physiological signal monitoring patch, the patch-ASIC chip
comprising a sensor interface coupled to the sensor, a processor
coupled to the sensor interface, a memory element coupled to the
processor, a radio coupled to the memory element; (b) managing the
power dissipation on the patch-ASIC chip with power management
circuits on the patch-ASIC chip; (c) transmitting data signals from
the radio on the patch-ASIC chip through an antenna incorporated
into the patch; (d) receiving the data signals at a base-ASIC chip
comprising a processor that processes data signals, a memory
element coupled to the processor, a radio coupled to the memory
element, power management circuits that coordinate power
dissipation on the base-ASIC chip, and a host interface through
which the base-ASIC chip communicates with a host device; and (e)
sending instructions wirelessly from the base-ASIC chip to the
patch-ASIC chip such that the base-ASIC chip coordinates a function
of the physiological signal monitoring patch.
[0042] In some embodiments a function coordinated by the base-ASIC
chip is initialization and link set up, power management, data
packet routing, type of transmission radio, radio transmit-power,
radio receive-sensitivity, patch operational integrity, audio
signal generation, display activation, or a combination thereof. In
some embodiments the ASIC chips function on a packet-data protocol
and the base-ASIC chip coordinates data packet routing. In some
embodiments the base-ASIC chip keeps track of the quality of the
wireless links between ASIC chips and sends commands to the
patch-ASIC chip and/or gate-ASIC chips to instruct the chips to
switch between UWB and narrowband radio or to raise or lower
transmit power in order to lower power consumption or to enhance
communication quality. In some embodiments the patch-ASIC chip is
authenticated by bringing the physiological monitoring patch in
proximity of the device comprising the base-ASIC chip.
[0043] In some embodiments the authentication is provided by an
encryption scheme using shared keys, wherein the device comprising
the base-ASIC chip wirelessly exchanges the shared keys with the
patch. In some embodiments the encryption scheme is an Advanced
Encryption Standard (AES) scheme. In some embodiments a user is
alerted with an audio and/or a visual signal. In some embodiments
the audio and/or visual signal is generated on the patch. In some
embodiments the audio and/or visual signal is generated on a device
to which the base-ASIC chip is connected.
[0044] In some embodiments the method is used to manage a patient
disease. In some embodiments the patient disease is arrhythmia,
heart failure, coronary heart disease, diabetes, sleep apnea,
seizures, asthma, COPD, pregnancy complications, and wound state or
combinations thereof. In some embodiments the method is used to
manage a condition related to the state of wellness and fitness of
a person. In some embodiments the condition being managed is weight
loss, obesity, heart rate, cardiac performance, dehydration rate,
blood glucose, physical activity or calorie intake, or combinations
thereof.
[0045] A method comprising monitoring a physiological condition
using three or more ASIC chips wherein the chips are designed to
work together to measure physiological signals, comprising: (a)
receiving physiological signals from sensors at a patch-ASIC chip
incorporated into a physiological signal monitoring patch, the
patch-ASIC chip comprising a sensor interface, a processor coupled
to the sensor interface, a memory element coupled to the processor,
a radio coupled to the memory element; (b) managing power
dissipation on the patch-ASIC chip with power management circuits
on the patch-ASIC chip; (c) transmitting data to a base-ASIC and/or
a gate-ASIC chip through an antenna in the patch; (d) receiving the
data sent from the patch-ASIC chip at the gate-ASIC chip, the
gate-ASIC chip comprising a processor that processes sensor data, a
memory element coupled to the processor, a radio coupled to the
processor that communicates with the patch-ASIC chip and the
base-ASIC chip, and power management circuits for coordinating
power dissipation on the gate-ASIC chip; (e) coordinating a
function on the patch-ASIC chip and/or gate-ASIC chip by sending
instructions from a base-ASIC chip to the patch-ASIC chip and/or
the gate-ASIC chip, wherein the base-ASIC chip comprises a
processor that processes sensor data, a memory element coupled to
the processor, a radio coupled to the memory element, power
management circuits for coordinating power dissipation on the
base-ASIC chip; and (f) sending data from the base-ASIC chip to a
host device through a host interface.
[0046] In some embodiments the base-ASIC chip is incorporated into
a .mu.-Base, the patch-ASIC chip is incorporated into a .mu.-Patch,
and the gate-ASIC chip is incorporated into a .mu.-Gate; wherein
each of the .mu.-Base, .mu.-Patch, and .mu.-Gate comprise a printed
circuit board and an antenna attached to the printed circuit board
for transmitting and receiving radio signals.
[0047] In some embodiments the gate-ASIC chip further comprises a
sensor interface for receiving signals from sensors, wherein the
gate-ASIC is incorporated into a patch.
[0048] In some embodiments the .mu.-Patch only transmits UWB, and
the .mu.-Gate comprises both UWB and narrowband radios.
[0049] In some embodiments the base-ASIC chip acts as a master
device to coordinate a function of the .mu.-Patch or the .mu.-Gate
or both the .mu.-Patch and the .mu.-Gate. In some embodiments the
base-ASIC chip keeps track of the quality of the wireless links
between ASIC chips and sends commands to the patch-ASIC chip and/or
gate-ASIC chips to instruct the chips to switch between UWB and
narrowband radio or to raise or lower transmit power in order to
lower power consumption or to enhance communication quality. In
some embodiments the base-ASIC chip is incorporated into the host
device; wherein the host device comprises a stationary, portable,
or mobile device or a stationary, portable, or mobile medical
instrument.
[0050] In some embodiments the base-ASIC chip is incorporated into
an adapter which plugs into the host device; wherein the host
device comprises a stationary, portable or mobile device or a
stationary, portable, or mobile medical instrument. In some
embodiments the gate-ASIC chip communicates wirelessly with both
the patch-ASIC chip and the base-ASIC chip. In some embodiments the
patch-ASIC chip and the gate-ASIC chip are each members of an ASIC
superset; and wherein an unused function on the patch-ASIC chip is
turned off
[0051] In some embodiments the patch-ASIC chip, the gate-ASIC chip
and the base-ASIC chip are each part of an ASIC superset chip,
wherein the functionality of two or more of the patch-ASIC chip,
the gate-ASIC chip and the base-ASIC chip are contained on the ASIC
superset chip, and wherein un-used portions of the superset chip
are turned off on the patch-ASIC chip, the gate-ASIC chip, or the
base-ASIC chip.
[0052] In some embodiments the base-ASIC chip is incorporated into
an adapter which plugs into the host device; wherein the host
device comprises a stationary, portable or mobile device or a
stationary, portable, or mobile medical instrument. In some
embodiments the adapter comprising the base-ASIC chip plugs into a
medical instrument through a serial interface connection. In some
embodiments the adapter provides physiological information from
wireless sensors to a stationary, portable, or mobile medical
instrument that was designed for receiving physiological
information from wired sensors, wherein the adapter allows the
medical instrument to receive substantially equivalent information
from the wireless sensors. In some embodiments the adapter allows a
medical instrument which is designed to be connected to sensors by
wires to be compatible with sensors that transmit wirelessly.
[0053] One aspect of the invention is a method comprising receiving
physiological signals from sensors at a patch wherein the patch
comprises a battery and an antenna each coupled to an integrated
circuit comprising a sensor interface that receives the
physiological signals from the sensor, a processor coupled to the
sensor interface that receives signals from the sensor interface
and processes the signals, a memory element coupled to the
processor that receives and stores signals, and a radio coupled to
the memory element that sends signals received from the memory
element to an antenna, wherein power management circuits coordinate
power dissipation on the chip; wherein the area of the patch
multiplied by the thickness of the patch is less than about 30
cm.sup.3; and wherein the patch can wirelessly transmit
physiological data for at least about 2 days while monitoring a
physiological signal from the patient without changing or
recharging the battery. In some embodiments the monitoring of the
physiological signal is sampled substantially continuously. In some
embodiments the signal is sampled substantially continuously at
greater than 200 Hz. In some embodiments method can wirelessly
transmit physiological data for at least about 4 days. In some
embodiments the battery provides a charge of about 250 mA-hours or
less. In some embodiments the patch buffers data obtained from
monitoring a physiological signal then transmits the data in
bursts. In some embodiments the patch uses on average less than
about 10 mW of power. In some embodiments the patch can transmit
more than about 1 KB of sensor data per day at a range of up to 30
m. In some embodiments the power management circuits coordinate
duty cycle with clock-gating with protocol-level sleep modes. In
some embodiments the patch can measure signals in continuous,
episodic, and/or periodic modes.
[0054] In some embodiments the patch also comprises the sensor. In
some embodiments the sensor comprises electrodes and senses
electrical signals. In some embodiments the sensor measures EEG,
EMG and ECG signals or combinations thereof. In some embodiments
the ASIC chip can send and/or receive both ultra-wideband (UWB) and
narrowband radio signals.
[0055] In some embodiments the patch comprises disposable and
reusable parts. In some embodiments a sensor and/or the battery are
disposable, and substantially all of the electronics are reusable.
In some embodiments the patch is disposable.
[0056] In some embodiments the sensor is separate from the patch
and electrically connected to the patch. In some embodiments the
sensor measures ECG, EEG, EMG, SpO2, tissue impedance, heart rate,
accelerometer, blood glucose, PT-INR, respiration rate and airflow
volume, body state, bone state, pressure, physical movement, body
fluid density, patient physical location, or audible body sounds,
or a combination thereof. In some embodiments the method can
generate stimulus signals that are detected by sensors connected to
or incorporated into the patch or connected to or incorporated into
another patch. In some embodiments the stimulus signals are
electrical, ultrasound, or radio wave signals. In some embodiments
the electrical signals are used to measure skin or body impedance.
In some embodiments the patch comprises an alert which is an audio
signal generator or a visual display. In some embodiments the
battery can be re-charged magnetically.
[0057] In some embodiments the patch is a cardiac patch that can
measure all of ECG, SpO2, tissue impedance, accelerometer, and
PT-INR signals. In some embodiments the patch is a neurological
patch for measuring sleep apnea that can measure all of EEG, EMG,
SpO2, heart rate, respiration rate and airflow volume, and pressure
signals. In some embodiments the patch is an endocrinological patch
for measuring diabetes or wounds that can measure all of ECG, blood
glucose, and UWB radar signals. In some embodiments the patch is
fitness and wellness patch that can measure all of ECG, heart rate,
accelerometer, and pressure signals.
[0058] One aspect of the invention is a method for unsupervised
placement of a physiological patch comprising: (a) placing the
patch that can receive wireless signals from a base device, wherein
the patch comprises a visual marker to help the user orient the
patch on the patient's body; (b) initializing the patch with a base
device by automatic verification of proper placement of the patch;
and (c) indicating the proper or improper placement of the patch to
the user with an audio or visual indication.
[0059] One aspect of the invention is a business method comprising:
a) manufacturing both a patch-ASIC chip and a base-ASIC chip
designed to work together to wirelessly communicate physiological
data, wherein each chip each comprises a processor, memory storage,
a wireless radio, and circuits for power management, wherein the
chips are designed to be used with a plurality sensor types; and
(b) selling and/or licensing the patch-ASIC chip and base-ASIC chip
to multiple customers for incorporation into physiological sensing
systems.
[0060] The business method of claim 141 wherein the plurality of
sensor types include sensors that measure all of ECG, EEG, EMG,
SpO2, tissue impedance, heart rate, and accelerometer signals.
[0061] The business method of claim 141 further comprising a
gate-ASIC chip designed to work together with the patch-ASIC chip
and the base-ASIC chip, to wirelessly communicate physiological
data, wherein each chip each comprises a processor, memory storage,
a wireless radio, and circuits for power management, wherein the
chips are designed to be used with a plurality sensor types.
INCORPORATION BY REFERENCE
[0062] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0063] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0064] FIG. 1A is a block diagram of a first embodiment of a
general architecture of wireless health monitoring system in
accordance with the present invention.
[0065] FIG. 1B is a block diagram of a second embodiment of a
general architecture of a wireless health monitoring system in
accordance with the present invention.
[0066] FIG. 2 illustrates examples of various sensors that can be
included in a distributed sensor network.
[0067] FIG. 3 illustrates a block diagram of a wireless patch in
accordance with the present invention.
[0068] FIG. 3A illustrates a block diagram of another embodiment of
a patch in accordance with the present invention.
[0069] FIG. 4 illustrates a block diagram of a medical signal
processor (.mu.-Base) in accordance with the present invention.
[0070] FIG. 4A illustrates a block diagram of another embodiment of
a medical signal processor (.mu.-Base) in accordance with the
present invention.
[0071] FIG. 5 is a block diagram of a cardiac care product in
accordance with the present invention.
[0072] FIG. 6 is a block diagram of an implementation of a mobile
device utilized with the cardiac care product of FIG. 5.
[0073] FIG. 7 illustrates a system of the present invention
including .mu.-Patches, .mu.-Gates, and a .mu.-Base incorporated
into a host device.
DETAILED DESCRIPTION OF THE INVENTION
[0074] The current invention relates to patches, integrated
circuits (chips), systems and methods for a wireless medical signal
processing system for health monitoring which can achieve high
wireless link reliability/security, low power dissipation,
compactness, low cost and supports a variety of sensors for various
physiological parameters. One aspect of the invention is a wireless
system for monitoring physiological conditions comprising two or
more ASIC chips that are designed to work together to optimize the
performance of a wireless monitoring system. One of the ASIC chips
is designed to be incorporated into a patch attached to a patient
(the patch-ASIC chip), and one of the ASIC chips is incorporated
into a mobile or stationary device (the base-ASIC chip). Typically,
the base-ASIC chip will be incorporated into a device that will
tend to be in the vicinity of the patient. The two or more ASIC
chips are designed in order to improve the performance of the
system by distributing the different aspects of functionality
between the different chip types. Thus the ASIC chips are designed
to function in an asymmetric manner in which the base-ASIC will
perform more of the processing intensive tasks. In some cases, the
base-ASIC will perform all or a majority of functions of a
particular type, while the patch-ASIC chip may perform all or a
majority of functions of another type. This asymmetric design of
the sets of ASIC chips can improve the performance of the
physiological monitoring system resulting in better management of
power, lower cost, and higher reliability.
[0075] In one aspect, the base-ASIC chip is designed to coordinate
some of the functions on the patch through the patch-ASIC chip. In
many cases, the base-ASIC is incorporated such that it has access
to much more power and energy than does the patch-ASIC chip. Thus,
the system of the current invention comprises an asymmetric system
in which the base-ASIC chip takes on more power and processor
intensive functions. This approach can result in lower power
dissipation at the patch, which can in turn result in a
physiological monitoring system in which the patch can collect and
transmit data for days or weeks without recharging or replacing
batteries. In addition, the base-ASIC can control the flow of data
in a network of patches in order to improve the management of data
relating to signals, increasing the amount and quality of
physiological information. For example, the base-ASIC chip can
supervise and control the functions of the patch-ASIC chip, for
example by controlling duty cycle, transmission mode, transmission
rate, and transmission timing. The base-ASIC and patch-ASIC chips
can be designed such that the coding/decoding functions are
asymmetric. For example, the patch-ASIC can be build to carry out
Turbo encoding, which is relatively simple, and the base-ASIC can
be designed to carry out Turbo-decoding which is more complex, and
requires more processing power and therefore uses more energy.
Another aspect of asymmetric design of the ASIC chips involves
providing a complex antenna scheme such as the use of multiple
antennas with smart antenna processing on the base-ASIC, and the
use of a single antenna with simple processing on the gate-ASIC.
Another aspect of the asymmetric design is the use of different
radio scheme capability on the gate-ASIC and base-ASIC chips. For
example, low-complexity transmitters (e.g. UWB) and low-complexity
receivers (e.g. Narrow-band) are employed on the on patch-ASIC; and
high-complexity transmitters (e.g. Narrow band) and high-complexity
receivers (e.g. UWB) are employed on the base-ASIC. Another aspect
of the asymmetry has to do with distributing the functions of
analyzing and controlling the radio channel. Here, the base-ASIC
has all the processors for analyzing the radio environment and
sending instructions to patch-ASIC to use a particular radio
scheme; and the patch-ASIC has simple circuits to just follow the
instructions coming from Base ASIC.
[0076] In some embodiments two or more of these distributed aspects
are coupled together, for example, where the base-ASIC and
patch-ASIC are designed to work together such that the base-ASIC
has processors for turbo-decoding, multiple antennas and smart
antenna processing capability, and high-complexity transmitters
(e.g. Narrow band) and high-complexity receivers (e.g. UWB); and
the patch-ASIC has processors for Turbo decoding, the capability of
receiving signals from a single antenna, and has low-complexity
transmitters (e.g. UWB) and low-complexity receivers.
[0077] One aspect of the asymmetric distributed processing of the
present invention is a patch-ASIC chip and a base-ASIC chip
designed to work together in which the area of the base-ASIC chip
is higher than that of the patch-ASIC chip. This difference in area
results, for example, from the fact that the base-ASIC chip takes
on the more processor intensive operations in carrying out the
monitoring of a patient's physical condition. In some embodiments,
the area of the base-ASIC chip is more than 2 times the area of the
patch-ASIC chip. In some embodiments, the area of the base-ASIC
chip is more than 4 times the area of the patch-ASIC chip.
[0078] One aspect of the asymmetric distributed processing of the
present invention is a method wherein a patch-ASIC chip and a
base-ASIC chip designed to work together and in which the power
consumed by the base-ASIC chip is higher than the power consumed by
the patch-ASIC chip. In some embodiments the power consumed by the
base-ASIC is 2 or more times the power consumed by the patch-ASIC
chip. In some embodiments the power consumed by the base-ASIC is 4
or more times the power consumed by the patch-ASIC chip. The power
consumption (power dissipation) of the chips can be measured, for
example during continual data transmission.
[0079] In some embodiments of the system the base-ASIC is
incorporated into a .mu.-Base (or medical signal processor (MSP))
comprising a printed circuit board and an antenna attached to the
printed circuit board. In some embodiments of the system the
patch-ASIC is incorporated into a .mu.-Patch comprising a printed
circuit board and an antenna attached to the printed circuit board.
In some embodiments, the antenna is a PCB antenna.
[0080] One aspect of the invention is an asymmetric system for
wireless monitoring wherein the two ASIC chips are designed such
that the base-ASIC chip carries out the more power and processor
intensive functions of the system. For example, in some
embodiments, the base-ASIC chip carries out smart antenna schemes,
which can be processor and power intensive, which allows the
.mu.-Base reliably detect weaker signals, thus allowing the
.mu.-Patch to transmit at lower power, saving energy on the patch.
Analogously, in some embodiments, the .mu.-Base will have multiple
antennas, e.g. 4 antennas, for implementation of the smart antenna
schemes. In some embodiments, in order to provide reliability for
the system while using low power at the patch, the base-ASIC chip
carries out decoding functions which are processor and power
intensive, while the patch-ASIC chip carries out encoding which is
less processor and power intensive. This asymmetric scheme is
facilitated in part because of the data transfer asymmetry of the
system in many embodiments, in which the patch is transmitting much
more data to the .mu.-Base than the .mu.-Base is transmitting to
the patch because the patch is generally transferring physiological
sensor data to the .mu.-Base, and the .mu.-Base is sending back
mainly instructions to control functions on the patch-ASIC chip and
the patch.
[0081] The base-ASIC chip can be connected to or built into a
stationary, portable, or mobile device. In some embodiments, the
base-ASIC chip is connected to or built into a cellular phone,
pager, i-Pod.TM., PDA, or other mobile device that would tend to be
carried by or be near the patient. In some embodiments, the
base-ASIC chip is connected to or built into a laptop, notebook,
palm-top, or desk-top computer. In some embodiments, the base-ASIC
chip is connected to or built into a medical instrument for
monitoring physiological signals related to health conditions such
as ECG, EEG, EMG, SpO.sub.2, tissue impedance, heart rate,
accelerometer, blood glucose, PT-INR, respiration rate and airflow
volume, UWB radar, pressure, physical movement, body fluid density,
patient physical location, or audible body sounds. The medical
instrument can be stationary, desk-top, portable, or mobile.
[0082] In some embodiments, the base-ASIC chip is incorporated into
an adaptor that is connected to a medical instrument such as a
medical monitor, wherein the adaptor communicates wirelessly with
one or more patches having a patch-ASIC chip. The adaptor receives
the physiological signal from one or more patches, translates the
physiological signal to a signal that is compatible with the
medical monitor, and sends the translated signal to the medical
monitor. In some embodiments, the adaptor is connected to the
medical monitor with the same connector to which the medical
monitor connects to wired sensors. In some embodiments, the adaptor
is connected to a medical monitor that was designed to work with
wired sensors through a different connection than used for the
wired sensors. For instance the adaptor may connect to the medical
device through a USB or SDIO port. In these embodiments, the
adaptor comprising the base-ASIC chip allows medical monitors
designed for use with wired sensors to be used with wireless
sensors with minimal or with no modification to the medical
monitor.
[0083] In some embodiments, in addition to the patch-ASIC chip and
the base-ASIC chip, the system further includes a gate-ASIC chip
incorporated into a gate device. In some cases the gate-ASIC chip
is attached to a .mu.-Gate, comprising a printed circuit board with
an antenna attached to the printed circuit board. In some
embodiments, the gate device acts as an intermediary (gateway), for
instance, controlling communication between the base-ASIC chip and
the patch-ASIC chip. The gate device is useful, for instance in
circumstances where the patient wearing the wireless patch may be
moved a distance away from the base-ASIC chip for relatively long
time periods. In these situations, the gate-device, which will
typically be small enough to, for example, be comfortably carried
in a pocket, can communicate with the patch-ASIC chip while the
patch-ASIC chip is out of communication range of the base-ASIC
chip, continuing to monitor and/or control the functions of the
patch, and collect and store data sent by the patch, and be able to
forward that data to the .mu.-Base wirelessly. In general, in
systems where one or more gate devices are present, patch devices
communicate to the .mu.-Base via the gate device(s). This helps
reduce the power consumption of the patch devices as they can
transmit at lower power to communicate with the gate device(s)
which are in closer proximity than the .mu.-Base itself.
[0084] In some embodiments the gate devices can be incorporated
into patches. In these cases, the gate device can perform its
gateway function, and can also perform as a patch by being
connected (wired) to sensors and receiving physiological signals.
For example, one system of the present invention has multiple
patches, each patch comprising a patch-ASIC chip; and a gate device
comprising a gate-ASIC chip incorporated into a patch on a patient.
The gate device can communicate with the multiple patches on the
patient, and the gate device can act as an intermediary between the
patches comprising the patch-ASICs and a .mu.-Base comprising a
base-ASIC. In one embodiment of this system, the patch-ASICs
communicate only by UWB, while the gate-ASIC can communicate with
the base-ASIC by either UWB or narrowband. This system allows the
patches with patch-ASICs to operate at low power and to have low
energy usage by transmitting only in UWB. In this embodiment, the
gate-device may have a larger battery than the patches comprising
the patch-ASIC chips. In some embodiments, the patch-ASIC chips
used in this scenario can be made inexpensively due to the fact
that the chips do not have multiple radios. In other embodiments,
the patch-ASIC chip and the gate-ASIC chip used in this scenario
are made as part of an ASIC superset, where the narrowband radio
can be turned off on the patch-ASIC chip. The use of an ASIC
superset chip can be advantageous where cost can be driven down by
producing a higher volume of a single type of chip.
[0085] In other embodiments, the gate device acts mainly as a
storage device for physiological information generated and
transmitted by the patch. For example, the gate device can have a
memory storage capability for storing data transmitted wirelessly
from the patch to the gate device. In this embodiment, the gate
need not send data wirelessly, and the stored data can be retrieved
via a physical connection to another device. For example, the gate
device may have a removable memory device, or the gate device may
have a connector which allows it to be connected to another device
in order to download the information on the gate device to another
device, such as a medical device or computer.
[0086] One aspect of the invention is the management of power
dissipation in a wireless monitoring system in a real environment
such as in a hospital, where the patch-ASIC chip, the base-ASIC
chip, and the gate-ASIC chip will end up at different distances
from one another in different circumstances. For example, the power
dissipation of the patch can be kept low by using low transmission
power at the patch, and/or by using a transmitting in a mode, such
as ultra-wideband (UWB) that uses less power. However, these power
management solutions may only be successful if the receiving device
is close enough to the sending device and has a sensitive enough
receiving capability to reliably receive the signals. Thus in the
present invention, the base-ASIC chip (and the .mu.-Base) generally
have adequate power available to carry out more power and processor
intensive functions, as the base-ASIC chip (and .mu.-Base) is
typically deriving its power from either a plugged-in stationary
device, or from a relatively large battery in a mobile or portable
device; whereas the patch-ASIC chip must conserve its power because
it is part of a patch which is generally small, light, and
inexpensive, and thus will only have a small battery with limited
power and energy. The chips, patches, systems, and methods of the
present invention provide for the base-ASIC chip, the .mu.-Base, to
use its power, resources, and functionality to lower the power
output requirements of the patch-ASIC chip, .mu.-Patch, and patch,
thus extending the time over which the patch can transmit patient
data without recharging or replacing the battery, and ensuring
secure and reliable communication with low power dissipation.
Wireless Technology (Radio)
[0087] The devices, systems, and methods of the invention relate to
the use of wireless technology. As used herein, the term "wireless"
refers to any suitable method of communicating without the use of a
hard-wired electrical connection. A hard-wired connection involves
the direct physical connection of electrical conductors through
which an electrical signal flows. The distances over which the
wireless communication occurs may be short (a few meters or less)
or long (kilometers or greater). The radio can be either
ultra-wideband (UWB) radio or narrowband radio. Narrowband radio,
as used herein, is any radio that is not ultra-wideband (UWB)
radio. For example, the Federal Communications Commission (FCC)
defines UWB as fractional bandwidth measured at -10 dB points where
(f_high-f_low)/f_center>20% or total Bandwidth>500 MHz. Some
examples of the narrowband radios suitable for the present
invention are: Wi-Fi standard based radio, Bluetooth standard based
radio, Zigbee standard based radio, MICS standard based radio, and
WMTS standard based radio. Suitable wireless radio protocols
include WLAN and WPAN systems.
ASIC chips
[0088] The invention utilizes integrated circuits that are ASIC
chips. An ASIC (Application Specific Integrated Circuit) is a
system-on-chip semiconductor device which is designed for a
specific application as opposed to a chip designed to carry out a
specific function such as a RAM chip for carrying out memory
functions. ASIC chips are generally constructed by connecting
existing circuit blocks in new ways. The ASIC chips described
herein are designed for the application of monitoring of
physiological signals wirelessly. In some embodiments the ASIC
chips of the invention comprise two or more ASIC chips that are
designed to work together. In some embodiments, the ASIC chips of
the present invention are made using a bulk CMOS process. In some
embodiments, the ASIC chip of the present invention encompasses
end-to-end functionality with the following features: Analog and
digital sensor electronics for multi-sensor processing; a
micro-controller based design to coordinate onboard resources and
perform power-control; hardwired PHY and MAC coprocessors which
enable highly integrated data-paths in small silicon-area, and a
CMOS radio with built-in power amplifier.
[0089] In some embodiments, the ASIC chips comprise circuits for
encryption and/or decryption, for advanced encryption standard
(AES), cyclic redundancy check (CRC), and/or forward error
correction (FEC).
[0090] The ASIC chips of the present invention are designed to
receive a variety of types of physiological signals. For example,
the ASIC chips of the invention can receive signals from ECG, EEG,
EMG, SpO.sub.2, tissue impedance, heart rate, accelerometer, blood
glucose, PT-INR, respiration rate and airflow volume, UWB radar,
pressure, physical movement, body fluid density, patient physical
location, or audible body sounds.
[0091] One aspect of the invention is an ASIC chip that is designed
to receive signals from multiple types of sensors. The capability
of receiving different types of signals can be important for the
economics of the ASIC chip for several reasons. For one, the cost
per chip drops with volume, and making a chip that can be used in
multiple applications allows for higher volumes and therefore lower
cost. In some cases the capability of measuring multiple types of
physiological signals is built into the ASIC chip, thus allowing
the ASIC chip to be directly connected to sensors without external
signal conditioning. In some embodiments, the ASIC chip of the
present invention has a programmable analog processor inside to
program the ASIC to accept multiple physiological signals.
[0092] One embodiment of the invention is an ASIC chip that is
designed to receive electrical physiological signals without the
need for external signal conditioning. One embodiment of the
invention is an ASIC chip that is designed to receive any of ECG,
EEG, EMG, SpO.sub.2, tissue impedance, heart rate, and
accelerometer signals without the need for external signal
conditioning.
[0093] The patch-ASIC chip of the present invention has the
functionality required to receive physiological signals from a
sensor, to wirelessly transmit the signals to a base device and in
some cases to control the functionality of the patch. The
patch-ASIC generally comprises at least a sensor interface for
measuring physiological signals, a processor for processing the
signals into sensor data, memory for storing data relating to the
signals, a radio for transmitting sensor data, and power management
circuits for controlling power on the chip.
[0094] In some embodiments, the patch-ASIC is capable of receiving
both analog and digital signals. In some embodiments, the
patch-ASIC supports and can receive signals from both passive and
active sensing. Active signals are signals that are created by
injecting an output signal and measuring a response. Active signals
include radio frequency signals, electrical, optical, and acoustic
signals (such as for blood-oxygen, body-impedance, ultrasound,
etc.).
[0095] The patch-ASIC generally has memory for storing
physiological data derived from the measured physiological signals.
The data stored in memory can be the data as received at the
sensor, or the data that has been processed. In some embodiments,
the data is processed before being stored. For example, in some
embodiments, the data is filtered to remove noise from the sample
before it is stored. In some embodiments, the ASIC has circuits for
the manipulating the data from the physiological signals. For
example, circuits include, but are not limited to, digital
filtering of sensor waveforms, lossless compression of sensor
waveforms, and parameter extraction to identify onset of a disease
condition (such as identifying a particular type of arrhythmia). In
some embodiments, different firmware is used to support different
disease conditions. An advantage of disease condition parameter
extraction is that it can considerably reduce the amount of data
that needs to be transmitted to the .mu.-Base, thereby reducing the
radio power-consumption. A tradeoff is the power consumed in
performing the local processing and the increased silicon-cost in
the form increased firmware memory or hardware processing
circuitry.
[0096] The patch-ASIC also generally has power management circuits
designed to control and minimize the energy used by the chip in
carrying out its functions. Power management circuits include, but
are not limited to, clock-gating and protocol-level active, sleep
and standby modes.
[0097] One use of the memory on the patch-ASIC is the use of the
memory as a buffer to allow the decoupling of the receiving of
signals and the transmission of data. Memory allows the patch-ASIC
chip, for example, to substantially continuously receive data, but
to transmit the data at a later time as a burst. This allows for
the use of less energy by lowering the amount of time spent
transmitting.
[0098] One aspect of the patch-ASIC chip is its ability to be
controlled by the base-ASIC chip. The patch-ASIC chip is able to
receive and respond to instructions sent by the base device, such
as instructions as to when to store data and when to transmit,
instructions on power levels, and instructions on which radio mode
to use (e.g. UWB or narrowband, or which narrowband frequency and
protocol). In some embodiments, the patch-ASIC chip is designed
only to have UWB radio in order to lower its power and energy
output. A patch-ASIC with only UWB, and not narrowband radio
capability can be useful in scenarios where the .mu.-Gate or
.mu.-Base can be kept near the patch, for example, where the
.mu.-Gate is incorporated into another patch on the same
patient.
[0099] The patch-ASIC is generally incorporated into a .mu.-Patch.
A .mu.-Patch comprises a printed circuit board (PCB) to which the
patch-ASIC is attached. The PCB also has an antenna attached that
is in electronic communication with the patch-ASIC through the
circuit board. The circuit board may be rigid or flexible. The
.mu.-Patch can also have additional components attached to the
circuit board to enhance the functionality of the patch. For
example, the .mu.-Patch can have a power amplifier for amplifying
the signal from the patch-ASIC in order to increase the range of
transmission by the antenna. The .mu.-Patch can also have
additional memory chips attached to the circuit board to increase
the memory storage capacity of the patch. In the case where the
patch performs active sensing, the .mu.-Patch can have components
attached to the circuit board that facilitate the output of
signals. The .mu.-Patch can have a component that is separate from
the patch-ASIC chip that performs digital signal processing (DSP).
In some cases, the patch-ASIC chip can perform DSP, and the
component that performs DSP enhances the DSP capability of the
.mu.-Patch. In some cases, the patch-ASIC chip does not have DSP
capability, and the component that performs DSP provides all of the
DSP capability on the .mu.-Patch.
[0100] The base-ASIC chip of the present invention has the
functionality for receiving data from the patch or the gate device,
transmitting the data to a host device, and for controlling the
functionality of the patch and/or the gate devices over the air.
The base-ASIC generally has at least a processor for processing
sensor data, memory for storing data relating to the signals, a
radio for transmitting instructions to the patch-ASIC chip and to
receive sensor data from it, power management circuits for
controlling power on the chip, and a host interface allowing the
base-ASIC chip to communicate with a host device. In some
embodiments, the base-ASIC chip also has sensor inputs, allowing
for some sensor signals to be directly received by the base device
through a wired connection. The base-ASIC will generally have more
processing power than the patch-ASIC or gate-ASIC, allowing the
base-ASIC to perform more power and processor intensive functions.
In some embodiments, the base-ASIC will have the ability to do
significant signal processing and data analysis. In some
embodiments, the base-ASIC will have the circuits for controlling
the initialization and link set up, power management, data packet
routing, type of transmission radio, radio transmit-power, radio
receive-sensitivity, patch operational integrity, audio tone
generation, display activation by the patch.
[0101] The base-ASIC is generally incorporated into a .mu.-Base (or
MSP). A .mu.-Base comprises a printed circuit board (PCB) to which
the base-ASIC is attached. The circuit board may be rigid or
flexible. The circuit board generally also has an antenna that is
in electronic communication with the base-ASIC through the circuit
board. The .mu.-Base can also have additional components attached
to the circuit board to enhance the functionality of the base
device. The .mu.-Base is described in more detail below.
[0102] Some embodiments comprise a gate-ASIC chip. The gate-ASIC in
some embodiments is incorporated into a gate device. The gate-ASIC
chip has the functionality for receiving data wirelessly from one
or more patches and for storing data in memory, and to forward the
data wirelessly to the .mu.-Base. The gate-ASIC generally has at
least a processor for processing sensor data, memory for storing
data relating to the signals, a radio for communicating with the
patch-ASIC chip, and power management circuits for controlling
power on the chip.
[0103] The gate-ASIC is generally incorporated into a .mu.-Gate. A
.mu.-Gate comprises a printed circuit board (PCB) to which the
gate-ASIC is attached. The PCB also has an antenna that is in
electronic communication with the gate-ASIC through the circuit
board. The circuit board may be rigid or flexible. The .mu.-Gate
can also have additional components attached to the circuit board
to enhance the functionality of the base device. For example, the
.mu.-Gate can have a power amplifier for amplifying the signal from
the gate-ASIC in order to increase the range of transmission by the
antenna. The .mu.-Gate can also have additional memory chips
attached to the circuit board to increase the memory storage
capacity of the gate device.
[0104] In some embodiments, the .mu.-Gate and the gate-ASIC chip
can be incorporated into a patch. In these embodiments, the
gate-ASIC chip will comprise a sensor interface for receiving
physiological signals.
[0105] In most embodiments, the ASIC chip of the present invention,
for example, the patch-ASIC chip, the gate-ASIC chip, or base-ASIC
chip, comprise a single chip. In some embodiments, however, the
ASIC chip can be physically on two chips. For instance, an ASIC
chip may comprise memory functionality or power amplifier
functionality that physically resides on a second chip but is used
functionally as if it were part of a single ASIC chip.
[0106] In some embodiments, the patch-ASIC chip, the base-ASIC
chip, and/or the gate-ASIC chip are manufactured as an ASIC
superset wherein the functionality of all of the types of chips are
on one chip, and the functionality that is not used on a given type
of chip is turned off in that chip. For example, in some cases the
patch-ASIC chip and the base-ASIC chip are made as a single ASIC
superset wherein the base-ASIC chip has a high power narrowband
radio that is turned off in the patch-ASIC chip.
[0107] In this application, we refer to a particular ASIC chip as
communicating with another ASIC chip, as used herein communication
with an ASIC chip is equivalent to there being communication
through an ASIC chip, and generally means that data or information
transferred from one ASIC chip reaches the other ASIC chip in some
form. It is understood that the ASIC chips will generally
communicate through antennae, and or other components.
Physiological Patch
[0108] The present invention relates to physiological patches for
the measurement of signals relating to a physical parameter in a
patient, and the transfer of data relating to the measured physical
signals to a remote location. The patches of the present invention
communicate wirelessly with a base device or with a gate device or
both a base and a gate device.
[0109] In some embodiments, the patch includes one or more sensors
incorporated into the patch. In other cases, the patch does not
include sensors, but is connected to the sensor by wires, and
receives physiological signals from the sensor through the wires.
In some cases, the patch includes one or more sensors, and in
addition, is connected by wires to other sensors that do not reside
on the patch.
[0110] The patches of the present invention are generally wearable.
In some cases they are held onto the skin with an adhesive. In some
cases, for example, where an electrical signal is being measured,
e.g. for ECG or EEG, some or all of the adhesive is electrically
conducting, for example comprising silver and or silver chloride.
In other cases, the adhesive is electrically non-conductive. The
patch adhesive can be either wet or dry. In some cases, the patch
can be held in place with straps or clips or may be incorporated
into a piece of wearable clothing such as a hat, gloves, socks,
shirt, or pants. In some cases, the patch is implanted. For
multiple Patches, for example for EEG monitoring, the patches can
be kept together (in sort of a shower-cap) so that they can be
applied over the head together.
[0111] The patches may be placed on any suitable part of the body
depending on the physiological signal and the condition to be
measured. For ECG monitoring, for example, in some embodiments, a
single patch can be used, the patch is placed on the upper-chest
area. For EEG monitoring, e.g. for monitoring sleep Apnea, multiple
patches are placed on the head.
[0112] The patches will generally be placed in direct contact with
the body. This will be the case for embodiments in which electrical
physiological signals are measured, and where the patch
incorporates the sensor. In other embodiments, the patch is in
proximity of the body, but not in direct contact. For example,
there may be no need for direct contact for applications such as
the measurement of SpO.sub.2 where the patch may be placed next to
a finger-tip assembly consisting of the LED/photodiode
combination.
[0113] In some embodiments, the patch consists of the patch-ASIC,
with multiple metal-electrodes (along with electrode-gel) on one
side to pickup sensor signals from the body, and PCB trace antenna
on the output side of the patch to radiate the radio (RF) signal. A
suitable patch of this type of patch is described in co-pending
U.S. Patent Application 60/940,072, and U.S. Patent Application
60/943,539, which are incorporated by reference herein in their
entirety.
[0114] In some embodiments, the patch-ASIC has built-in
sensor-signal processing for physiological signals such as ECG and
EEG. In some embodiments, sensor-signal processing is provided by
components within the patch, but not included on the ASIC. For
example, circuitry such as analog amplification and filtering can
be on the patch in separate components. The additional components
can be used for example for active sensing applications such as
blood-oxygen level (SpO2), which require outputs to drive light
emitting diodes (LEDs, e.g. red/infra-red) whose light is usually
passed through a finger-tip and captured by a photodiode and fed
back to the ASIC for further processing. The finger-tip
sensor-assembly (LEDs and photodiode) is generally not incorporated
into the patch itself. There will generally be dedicated
inputs/outputs on the patch to connect to this sensor assembly,
and/or to similar sensor assemblies. Digital sensor signals can
also be input to the Patch, and processed by the ASIC. One aspect
of the invention is a patch that is capable of measuring ECG, EEG,
EMG, SpO.sub.2, tissue impedance, heart rate, accelerometer, blood
glucose, PT-INR, respiration rate and airflow volume, UWB radar,
pressure, physical movement, body fluid density, patient physical
location, and audible body sounds. In some embodiments the patch
comprises an ASIC that can measure ECG, EEG, EMG, SpO.sub.2, tissue
impedance, heart rate, and accelerometer signals without external
signal conditioning.
[0115] In some embodiments, the patch is a cardiac patch that can
measure all of ECG, SpO.sub.2, tissue impedance, accelerometer, and
PT-INR signals. In some embodiments, the patch is a neurological
patch for measuring sleep apnea that can measure all of EEG, EMG,
SpO.sub.2, heart rate, respiration rate and airflow volume, and
pressure signals. In some embodiments, the patch is an
endocrinalogical patch for measuring diabetes/wound that can
measure all of ECG, blood glucose, and UWB radar signals. In some
embodiments, the patch is a fitness and wellness patch that can
measure all of ECG, heart rate, accelerometer, and pressure
signals.
[0116] In some embodiments, the patch includes a PCB antenna,
battery, sensor-electrodes, as well as the electronics section
comprising the .mu.-Patch with patch-ASIC and other electronic
components. The electrodes section and electronics section are
typically manufactured separately and assembled together, along
with the battery. In some embodiments, the electrodes section is
flexible, and the electronics section is semi-rigid or flexible. In
some embodiments, both sections are mass produced, machine
assembled and tested. The term "batteries" will generally be used
herein but it is to be understood that generally another power
source other than a battery could also be used.
[0117] The patches of the invention generally have a power source
incorporated into the patch. The battery is electrically connected
to the patch-ASIC chip. The power source can be any suitable power
source. The power source is typically a battery such as Li-ion,
NiCD, NiMH, or Zn-air battery. In some embodiments, the power
source can be a source other than a battery, for example, an
ultracapacitor, micro-fuel cell, micro-heat engine, or radioactive
power source. Because the patch is generally meant to be worn, the
battery should be small and light. In some cases, the battery is
removably attached the patch. In some cases, the battery is
substantially irreversibly attached to the patch, for example,
soldered onto the PCB of the .mu.-Patch. In some cases the battery
is rechargeable, for example magnetically rechargeable without
electrical contact with the recharging device.
[0118] In some embodiments, the patch comprises an alert
incorporated into the patch. The alert can provide the user, for
example, with information about the state of the patch, the proper
placement of the patch, the distance of the user from the base
device, the state of the battery in the patch, or the time the user
has been outside of a communication range with the base device. The
alert can also be used to inform the user of a particular health
condition or of a recommended action to take due to the measured
physiological signals. For example, the alert can be used to
recommend that the patient take a medication and/or to contact
medical professionals. The alert can be, for example, audio,
visual, or vibration based. In some cases, the alert is at the base
or gate device. The audio alert can be, for example, a small
speaker that either beeps or chimes to alert the user, or may have
more complex audio output including using language to communicate
with the user. A visual alert can be, for example, a flashing or
constant light such as an LED, or can comprise a display that
displays signals to the user, such as a liquid crystal display
capable of displaying alpha-numeric characters.
[0119] In one embodiment, an alert on the patch (or on the base or
gate) is used to provide confirmation of proper patch placement to
the user at the time of patch placement. For example, the patch may
monitor test signals to confirm correct placement. The confirmation
of correct placement can be carried out in some cases by the patch,
and in some cases with a combination of the base device and the
patch, e.g. by holding the base device near the patch. An
audio-alert at the Patch could be used for when a patient goes out
of the effective range of a .mu.-Base.
[0120] In some embodiments, the patches of the present invention
are disposable after use. For example, electrodes with wet/dry gel
may be non-reusable once they are peeled-off the body, thus a patch
comprising electrode sensors would generally be disposed of after
use. In other embodiments, the patch is manufactured in a two-piece
configuration such that the electrodes in one piece are disposable,
but the .mu.-Patch with the patch-ASIC and associated electronics
in another piece is reusable by connection to another electrode
bearing piece.
[0121] It is generally desired that the patches be comfortable to
wear, and thus the patches of the invention are typically small. In
some embodiments the patches are relatively thin and flat, so as to
be placed on the surface of the body. In some embodiments portions
of the patch are flexible to conform to the body. In some
embodiments, the patches are less than about 30 cm.sup.2 in area.
In some embodiments, the patches are less than about 20 cm.sup.2 in
area. In some embodiments, the patches are less than about 10
cm.sup.2 in area. In some embodiments, the patches are less than
about 5 cm.sup.2 in area. In some embodiments, the patches are less
than about 2 cm thick. In some embodiments, the patches are less
than about 1 cm thick. In some embodiments, the patches are less
than about 0.5 cm thick. In some embodiments, the patches are less
than about 0.2 cm thick.
[0122] In some embodiments, the patches are less than about 30
cm.sup.2 in area and less than about 1 cm thick. In some
embodiments, the patches are less than about 20 cm.sup.2 in area
and less than about 1 cm thick. In some embodiments, the patches
are less than about 20 cm.sup.2 in area and less than about 0.7 cm
thick. In some embodiments, the patch comprises electrodes for
measuring ECG and is about 15 cm.sup.2 to about 25 cm.sup.2 in area
and about 0.5 cm to about 1 cm thick.
[0123] In some embodiments, the patches have a volume of less than
about 30 cm.sup.3. In some embodiments, the patches have a volume
of less than about 20 cm.sup.3. In some embodiments, the patches
have a volume of less than about 15 cm.sup.3. In some embodiments,
the patches have a volume of less than about 10 cm.sup.3. In some
embodiments, the patches have a volume of less than about 5
cm.sup.3.
[0124] One aspect of the invention is a patch, used as part of a
system that has relatively low volume as that described above but
can monitor and transmit data for relatively long periods of time
without having to replace or recharge the batteries.
[0125] In some embodiments, devices, systems and methods of the
invention provide a patch that can wirelessly transmit data while
monitoring a physiological signal from a patient for at least about
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 17, 21, 28 or more than
28 days without changing or recharging the batteries. In some
embodiments, the patch can wirelessly transmit data while
substantially continuously monitoring a physiological signal from a
patient for at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12,
14, 17, 21, 28 or more than 28 days without changing or recharging
the batteries.
[0126] As referred to herein, a patch is substantially continuously
monitoring a physiological signal when it is sampling the
physiological signal at regular intervals where the sampling rate
is such that the physiological condition is effectively monitored
over the time period. The frequency of sampling will depend on the
particular physiological condition that is monitored, and the time
frame during which a meaningful measurable event will occur. In
some cases the appropriate rate can be determined by using the
Nyquist rate. The Nyquist rate is the minimum sampling rate
required to avoid aliasing, equal to twice the highest modulation
frequency contained within the signal. In other words, the Nyquist
rate is equal to the two-sided bandwidth of the signal (the upper
and lower sidebands). For example, for measuring ECG signals, the
relevant physiological signal information occurs at a rate of about
100 Hz, thus the sampling should be at a minimum of about 200 Hz.
In some cases, it is prudent to sample at a rate higher than the
Nyquist rate. In some embodiments of the invention, the
physiological signal that is continuously monitored is an ECG
measurement which is continuously sampled at a rate of 200 Hz to
800 Hz. In some embodiments of the invention, the physiological
signal that is continuously monitored is an ECG measurement which
is continuously sampled at a rate of 300 Hz to 500 Hz. In some
embodiments of the invention, the physiological signal that is
continuously monitored is an ECG measurement which is continuously
sampled at a rate of about 400 Hz. The term substantially
continuous includes situations where the measurement is interrupted
for a fraction of the time of the measurement. For example a
substantially continuous measurement would occur if the continuous
measurement occurred over a substantial period of the time of
measurement.
[0127] In some embodiments, the patch can wirelessly transmit data
while monitoring a physiological signal from a patient for at least
about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 17, 21, 28 or more
than 28 days without changing or recharging the batteries where the
battery in the patch with a type of battery that provides, on
average, less than about 50, 100, 150, 200, 250, 300, 400, 600,
800, 1000, or 1200 mA-hours.
[0128] In some embodiments, the patch can transmit about 1, 2, 5,
10, 15, 20, 25, 30, 35, 37, 40, 50, 60, 75, 90, 100, 500 or more
than 500 KB or 1, 2, 5, 10, 15, 20, 25, 30, 35, 37, 40, 50, 60, 75,
90, 100 or more than 100 MB of data per day while monitoring a
physiological signal from a patient for at least about 1, 2, 3, 4,
5, 6, 7, 8, 9, 10, 11, 12, 14, 17, 21, 28 or more than 28 days
without changing or recharging the batteries. In some embodiments,
the patch can transmit about 5 MB of data per day while monitoring
a physiological signal from a patient for at least about 2 days
without changing or recharging the batteries. In some embodiments,
the patch can transmit about 10 MB of data per day while monitoring
a physiological signal from a patient for at least about 2 days
without changing or recharging the batteries. In some embodiments,
the patch can transmit about 20 MB of data per day while monitoring
a physiological signal from a patient for at least about 2 days
without changing or recharging the batteries. In some embodiments,
the patch can transmit about 50 MB of data per day while monitoring
a physiological signal from a patient for at least about 2 days
without changing or recharging the batteries. In some embodiments,
the patch can transmit about 5 MB of data per day while monitoring
a physiological signal from a patient for at least about 4 days
without changing or recharging the batteries. In some embodiments,
the patch can transmit at least about 20 MB of data per day while
monitoring a physiological signal from a patient for at least about
7 days without changing or recharging the batteries. In some
embodiments, the patch can transmit at least about 20 MB of data
per day while monitoring a physiological signal from a patient for
at least about 14 days without changing or recharging the
batteries.
[0129] In some embodiments, the patch can transmit at least about
1, 2, 5, 10, 15, 20, 25, 30, 35, 37, 40, 50, 60, 75, 90, 100, 500
or more than 500 KB or 1, 2, 5, 10, 15, 20, 25, 30, 35, 37, 40, 50,
60, 75, 90, 100 or more than 100 MB of sensor data per day at a
range of up to about 30 m while monitoring a physiological signal
from a patient for at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,
11, 12, 14, 17, 21, 28 or more than 28 days without changing or
recharging the batteries. In some embodiments, the patch can
transmit at least about 5 MB of sensor data per day at a range of
up to about 30 m while monitoring a physiological signal from a
patient for at least about 2 days without changing or recharging
the batteries. In some embodiments, the patch can transmit at least
about 10 MB of sensor data per day at a range of up to about 30 m
while monitoring a physiological signal from a patient for at least
at least about 2 days without changing or recharging the batteries.
In some embodiments, the patch can transmit at least about 20 MB of
sensor data per day at a range of up to about 30 m while monitoring
a physiological signal from a patient for at least about 2 days
without changing or recharging the batteries. In some embodiments,
the patch can transmit at least about 50 MB of sensor data per day
at a range of up to about 30 m while monitoring a physiological
signal from a patient for at least about 2 days without changing or
recharging the batteries. In some embodiments, the patch can
transmit at least about 10 MB of sensor data per day at a range of
up to about 30 m while monitoring a physiological signal from a
patient for at least about 4 days without changing or recharging
the batteries. In some embodiments, the patch can transmit at least
about 10 MB of sensor data per day at a range of up to about 30 m
while monitoring a physiological signal from a patient for at least
about 7 days without changing or recharging the batteries. In some
embodiments, the patch can transmit at least about 10 MB of sensor
data per day at a range of up to about 30 m while monitoring a
physiological signal from a patient for at least about 14 days
without changing or recharging the batteries.
[0130] In some embodiments, the patch uses less than about 1, 2, 3,
4, 5, 6, 7, 8, 9, 10, 15, 20 mW of power on average. In some
embodiments the patch has a volume that is less than about 20, 30,
40, 50, or 60 cm.sup.3 and uses less than about 1, 2, 3, 4, 5, 6,
7, 8, 9, 10, 15, 20 mW of power on average. In some embodiments,
the patch has a volume that is less than about 30 cm.sup.3 and uses
less than about 10 mW on average. In some embodiments, the patch
has a volume that is less than about 30 cm.sup.3 and uses less than
about 6 mW on average. The volume of the patch can be calculated in
some cases, for example, where the patch is in the shape of a disk,
by multiplying the area of the patch by the thickness of the
patch.
[0131] The term "sensor data" is used to describe the amount of
data transmitted from the patch to the .mu.-Base. In this context
sensor data means the data that is sent from the patch that
directly correlates with the physiological signal and excludes data
sent, for example as part of an encryption scheme.
Base Device (.mu.-Base)
[0132] One aspect of the invention is the base device which
comprises a .mu.-Base which includes a base-ASIC chip. The
base-ASIC is generally incorporated into a .mu.-Base (or MSP). A
.mu.-Base comprises a printed circuit board (PCB) to which the
base-ASIC is attached. The circuit board may be rigid or flexible.
The circuit board generally also has an antenna that is in
electronic communication with the base-ASIC through the circuit
board. The .mu.-Base can also have additional components attached
to the circuit board to enhance the functionality of the base
device. The .mu.-Base receives sensor data from one or more patches
and or gate devices. The .mu.-Base generally processes the sensor
data, and sends the processed sensor data to a host device. In
addition, the .mu.-Base controls functions of the patch including
supervising power management and controlling data flow.
[0133] The host device is a device which can host a .mu.-Base
module. In some embodiments, the .mu.-Base is incorporated into
host device, and can for example, be fully integrated within the
host. The base-ASIC can be soldered onto a board within a host
device such as mobile medical monitor which provides power to the
base-ASIC chip and may provide other functionality such as an
antenna. In some embodiments, the .mu.-Base can be either connected
to the host as an external device via a host interface bus. In some
embodiments, the .mu.-Base is incorporated into a device, such as a
card that connects with the host device. In some embodiments, the
.mu.-Base is incorporated into an adaptor which connects to the
host device. The .mu.-Base adaptor can connect to the host device
by any suitable input or input/output port. In some embodiments,
the .mu.-Base connects to the host device through a serial port
with an interface such as USB or SDIO.
[0134] The host devices can be any suitable stationary, portable,
or mobile device or a stationary, portable, or mobile medical
instrument. Examples of host devices include a cellular phone,
pager, i-Pod.TM., PDA, watch, or other mobile device, laptop,
notebook, palm-top, or desk-top computer, or a medical instrument.
Suitable medical instruments include medical instruments for
monitoring health conditions by measuring physiological signals
such ECG, EEG, EMG, SpO.sub.2, tissue impedance, heart rate,
accelerometer, blood glucose, PT-INR, respiration rate and airflow
volume, UWB radar, pressure, physical movement, body fluid density,
patient physical location, or audible body sounds. The medical
instrument can be stationary, desk-top, portable, or mobile. One
aspect of the invention involves using a .mu.-Base incorporated
into an adaptor in order to allow a medical instrument designed to
measure sensor data through wired connections to measure similar
sensor date through a wireless connection. This allows for
conversion of a wired-sensor medical device into a wireless sensor
medical device. In some embodiments, the adaptor connects to the
medical device through the same connectors to which the wired
sensors were connected. In other cases, the .mu.-Base adaptor
connects to the medical device through another port on the medical
device. For example, where a medical device was designed to measure
pulse-rate with wired sensors that connect directly into the
medical device, the .mu.-Base adaptor could plug into the jacks
into which the wired sensors are designed to be connected. In this
case, the .mu.-Base would receive the wireless signal from the
.mu.-Patch, convert the signal if needed and send the signal to the
medical instrument. Alternatively, the .mu.-Base adaptor could be
made to plug into another port such as a USB port on the medical
instrument. In this case, the .mu.-Base would convert the wireless
signals from the .mu.-Patch into signals appropriate for
transmission via this port. The .mu.-Base adaptor form-factor
depends on the host-device as well as application. It can be, for
example of USB-stick or mini-SD.
[0135] In some embodiments, the .mu.-Base will derive its power
from the host device. In some embodiments, the .mu.-Base will have
associated power sources such as batteries. The .mu.-Base will
generally have more energy available to it than the .mu.-Patch. The
present invention allows for the .mu.-Base to perform the more
power and processor intensive functions, conserving the energy
usage of the .mu.-Patch.
[0136] One aspect of the invention is the utilization of the
.mu.-Base as a master device, where the .mu.-Base can test,
control, and monitor the functions of .mu.-Patches and/or
.mu.-Gates by sending and/or receiving test signals and/or control
signals. Examples of functions that are controlled by the .mu.-Base
include initialization and link set up, power management, data
packet routing, type of transmission radio, radio transmit-power,
radio receive-sensitivity, patch operational integrity, audio tone
generation, display activation, or a combination thereof.
[0137] In some embodiments, a network made up of the .mu.-Base,
.mu.-Patch(es), and .mu.-Gate(s) work on a packet-data protocol.
Using this network, .mu.-Base keeps track of the link-quality of
various wireless links between the .mu.-Base, .mu.-Patch(es), and
.mu.-Gate(s) and takes corrective actions as needed. For example,
if the link from a .mu.-Patch to one of the .mu.-Gate degrades too
much, the .mu.-Base can send a command to the .mu.-Patch to switch
its link to a standby .mu.-Gate for better link quality.
[0138] In some embodiments, the .mu.-Base can instruct the
.mu.-Gate to switch from a UWB radio to narrowband radio depending
on certain signal quality parameters. In the absence of strong
narrowband interference, for instance, UWB link is used. When
strong narrowband interference is detected (thereby degrading link
quality), a narrowband link is used with a different narrowband
carrier until the narrowband interferer disappears. The link is
then switched back to UWB. This scheme results in lower overall
power consumption because UWB radio consumes less power. Systems
for wireless communication using multiple radios is described in
co-pending U.S. Patent Application 60/894,174, U.S. Patent
Application 60/894,093, and U.S. Patent Application 60/943,540
which are incorporated by reference herein in their entirety.
[0139] In some embodiments, the .mu.-Base can also control
.mu.-Patch transmit power by issuing commands to reduce/increase
transmit power depending on the receive signal strength. This helps
save energy and provides higher reliability. The .mu.-Base can also
issue commands to .mu.-Patch(es) to go into sleep-modes to conserve
power.
[0140] In some embodiments, the .mu.-Base sends periodic commands
to instruct .mu.-Patch(es) to transmit data. Implementing the
power-control algorithms on the .mu.-Base helps simplify the
.mu.-Patch implementation, reducing cost and power.
[0141] In some embodiments, the .mu.-Base performs duty-cycle
control. For example, the .mu.-Base performs clock-gating with
protocol-level sleep modes to reduce power dissipation. For
example, during RF transmission, the receive-section is turned off
and during RF reception, the transmit-section is turned off. During
silent periods, only the front-section of the radio receive-chain
stays on to listen for packets meant for the particular Patch, and
wakes-up the rest of the receiver when it detects them.
[0142] In some embodiments, the .mu.-Base performs functional
allocation on the .mu.-Patch, and/or .mu.-Gate. The .mu.-Base can
dynamically alter the performance of the functional blocks. For
example, receiver sensitivity and transmit phase-noise can depend
on the biasing of the RF circuitry, which in turn affects
power-consumption. When a transmitter is nearby, the receiver
doesn't need high sensitivity, so it can reduce it by reducing the
bias, saving power. Similarly, in a low interference environment,
higher phase-noise could be tolerated, saving power. In addition,
lower energy use by the patch is achieved by using asymmetric
schemes that require more powerful coding and modulation schemes
with more complex receive processing on the .mu.-Base, while
requiring simple transmit-processing on the .mu.-Patch. More
powerful receive processing on the .mu.-Base include, for example
turbo-decoding (forward error-correction) and smart-antenna
schemes. These schemes lessen the burden for the .mu.-Patch to
transmit high-power to maintain a reliable communication-link, thus
saving energy. Suitable smart antenna schemes are described in
co-pending U.S. Patent Application 60/943,538 which is incorporated
by reference herein in its entirety. The smart antenna schemes can
use beam-forming techniques, and can involve data processing to
enhance signal to noise. In some embodiments, the smart antenna
scheme on the .mu.-Base comprises more than one antenna. In some
embodiments, the smart antenna scheme on the .mu.-Base comprises
two or more antennae. In some embodiments, the smart antenna scheme
on the .mu.-Base comprises 4 or more antennae. In some embodiments,
the smart antenna scheme on the .mu.-Base comprises 2, 3, 4, 5, 6,
7, 8, 12 or more than 12 antennae. In some embodiments, the smart
antenna scheme on the .mu.-Base comprises about 4 antennae.
[0143] In some embodiments, the .mu.-Base performs authentication
of patches at the time of their placement on the body and their
initialization. By bringing the .mu.-Patch close to the .mu.-Base
at the time of placement, private user-specific key can be
transferred from the .mu.-Base to the .mu.-Patch. In some cases, by
being close to the .mu.-Patch, the .mu.-Base can transmit the key
at very low-power so that other devices cannot listen to the key
transmission. By using this active authentication/initialization
process by the .mu.-Base, long sequences of .mu.-Patch discovery
and authentication similar to generic wireless networks is avoided,
thereby saving power.
[0144] In some embodiments, the patch-ASIC on the .mu.-Patch
comprises an encoding scheme for encoding transmission, and the
base-ASIC chip on the .mu.-Base comprises both an encoding scheme
and a decoding scheme, wherein the decoding scheme on the .mu.-Base
is more power and processor intensive than the encoding scheme on
the .mu.-Patch. In some embodiments, the encryption scheme uses
shared keys, wherein the device comprising the base-ASIC chip
wirelessly writes the shared keys to the patch. In some
embodiments, the patch-ASIC chip has a simple turbocode encoder,
and the base-ASIC chip has the more complex turbocode decoder. In
some embodiments, the encryption scheme is an Advanced Encryption
Standard (AES) scheme, where the decryption part of the scheme
resides on the base-ASIC chip.
Gate Device (.mu.-Gate)
[0145] One aspect of the invention is the gate device which
comprises a .mu.-Gate which includes a gate-ASIC chip. The gate
device is generally a small portable device that can easily be kept
on or near the user. For example, the gate device can be of the
size that can be comfortably kept in a pocket. In some embodiments,
the gate device could have, for example, the area of a credit card,
about 2 inches by about 3 inches, and less than about 0.5 inches
thick. In some cases, the gate device can act as an intermediary
device between the .mu.-Base and the .mu.-Patch. In other cases,
the gate device can act primarily as a memory storage device, to
store data transmitted by the patch. In some embodiments, the
.mu.-Gate can be incorporated into a patch where it can act as a
higher performance patch where it can perform physiological sensing
functions like a regular patch comprising a patch-ASIC. For
example, the patch comprising the .mu.-Gate can act as a gateway
for multiple other patches on the same patient. The patch
comprising the .mu.-Gate can, for example, have the capacity to
communicate in either UWB or narrowband with the .mu.-Base, and may
have a larger memory capacity and a larger battery than the other
patches. The other patches comprising patch-ASICs can operate at
lower power by, for example communicating only by UWB with the
.mu.-Gate which will always be close to the patches if placed on
the same patient. The .mu.-Gate, however, will have the capacity to
manage communication with the .mu.-Base, which may sometimes be
farther away from the .mu.-Gate, necessitating, for example
communication by narrowband which requires more power and energy
and/or the storage of larger amounts of data on the .mu.-Gate. The
.mu.-Gate can collect data from other patches to send to a
.mu.-Base.
[0146] For example, in a system with multiple patches, the gate
devices are introduced to aggregate the .mu.-Patch sensor data
(wirelessly) and then transmit it to the .mu.-Base (essentially
acting as gateways). This allows the .mu.-Patches to spend much
less energy to reliably transmit data to an on-body or nearby
.mu.-Gate device as opposed to a .mu.-Base device that could be
tens of meters away. In some cases a redundant (standby) .mu.-Gates
is used for reliability in case the primary .mu.-Gate is
unreachable by either .mu.-Patches or .mu.-Base. The standby
.mu.-Gate can also be used as load-balancer and data backlog
remover when links of multiple patches to the primary .mu.-Gate
degrade temporarily, and there is a need to catch up with clearing
the buffered data in Patches by sending it to the .mu.-Base using
both primary and secondary .mu.-Gates.
[0147] One aspect of the invention is a system for monitoring
physiological signals comprising two or more ASIC chips wherein the
chips are designed to work together to measure physiological
signals, comprising: (a) a patch-ASIC chip for incorporation into a
physiological signal monitoring patch comprising a sensor interface
for measuring physiological signals, a processor for processing the
signals into sensor data, memory for storing data relating to the
signals, a radio for transmitting sensor data, and power management
circuits for controlling power on the chip; and (b) a base-ASIC
chip comprising a processor for processing sensor data, memory for
storing data relating to the signals, a radio for transmitting
instructions to the patch-ASIC chip, power management circuits for
controlling power on the chip, and a host interface allowing the
base-ASIC chip to communicate with a host device. Generally the
base-ASIC chip is incorporated into a .mu.-Base and the patch-ASIC
chip is incorporated into a .mu.-Patch, wherein both the .mu.-Base
and the .mu.-Patch comprise a printed circuit board and an antenna
attached to the printed circuit board for transmitting radio
signals.
[0148] In some embodiments, the base-ASIC acts as a master device
to control a function of the .mu.-Patch or the .mu.-Gate or both
the .mu.-Patch and the .mu.-Gate. Examples of functions controlled
by the base-ASIC are initialization and link set up, power
management, data packet routing, type of transmission radio, radio
transmit-power, radio receive-sensitivity, patch operational
integrity, audio tone generation, display activation, or a
combination thereof.
[0149] FIG. 7 shows an exemplary system that includes a .mu.-Gate.
The system has multiple .mu.-Patches (.mu.P) that are placed on the
body of a patient. The system has a .mu.-Base, which in this
embodiment is shown as being incorporated into a host device in the
form of a cellular phone or PDA. The .mu.-Base can be incorporated
either directly as an integral part of the host device or as part
of an adaptor, such as a card that plugs into the host device. The
system depicted has more than one .mu.-Gate that can communicate
with the .mu.-Patches. In the system shown in FIG. 7, the
.mu.-Gates are acting as intermediary devices that receive data
from the .mu.-Patches and send data to the .mu.-Base. In addition,
in some embodiments, the .mu.-Gates can receive and relay
instructions from the .mu.-Base to the .mu.-Patches. In some cases,
multiple .mu.-Gates can be used to provide a backup for receiving
information from the .mu.-Patches, either to enhance the
communication link by using, for example, the closest .mu.-Gate, or
by enhancing the utilization of memory capacity. FIG. 7 shows that
the system may also have an optional remote server which receives
information related to the sensor data from the host device. In
some cases, the remote server is a secure server that has other
patient data to which the data from the host device can be
added.
[0150] In some embodiments the host-device further communicates
with a secure server to which information derived from the
physiological sensors is transmitted. The transfer of information
from the host device can be wireless, or by direct wired
connection. Connection to the remote-monitoring server from the
.mu.-Base or host-device would depend on the type of network
connection the host-device has. It could be Wi-Fi (WLAN),
cellular-data (GPRS/3G-CDMA), wired LAN/WAN (Ethernet/DSL/Cable),
or wireless broadband WAN (WiMax). The secure server can, for
example, integrate the information from the host device with other
patient information.
[0151] The system of the present invention allows for the reliable
and secure transmission of information related to a patient's
condition. Reliability is the ability to transfer information
accurately. In some embodiment, reliability is enhanced through
schemes to make the wireless link reliable; for example by forward
error-correction, packet-retransmission (automatic repeat-request
or ARQ) and smart-antenna techniques on the receiver side.
Retransmission requires buffering of data on the transmit side (as
well as on the receive side when packets are received out of
sequence). Interference from other users wearing similar patches is
avoided by either frequency-hopping their carrier-frequencies in a
pseudo-random fashion, or modulating their data with different
pseudo-random code sequences with low cross-correlation
properties.
[0152] Security relates to the ability of the system to keep the
contents of the wireless transmission indecipherable to the
third-party. In some embodiments of the invention, security is
enhanced through encryption such as 128-bit AES (Advanced
Encryption System) encryption. Packets are encrypted on the
transmit side and decrypted on the receive side using a set of
shared-keys. In one embodiment, the base device wirelessly writes
these keys to the patch during initialization by placing the
.mu.-Base and .mu.-Patch next to each other to prevent third-party
listening. The keys can be made unique by virtue of unique ID's
associated with each user.
[0153] The systems of the invention include continuous, periodic,
or episodic measurement of a physiological condition. For example,
one embodiment of a continuous monitoring scheme is a wireless
Holter monitor. A Holter monitor is a portable device for
continuously monitoring the electrical activity of the heart,
typically for 24 hours or more. Its extended recording period is
sometime useful for observing occasional cardiac arrhythmias that
would be difficult to identify in a shorter period of time. For
patients having more transient symptoms, a cardiac event monitor
which can be worn for a month or more can be used. The Holter
monitor of the present invention records electrical signals from
the heart via a one or more patches, each comprising .mu.-Patch
with a patch-ASIC. The patches have electrodes that are typically
attached to the chest. The number and position of patches with
electrodes can vary, for example from one to eight. The patches
monitor the electrical signals from the patient and transmit the
sensor data to a .mu.-Base that is in a device that is kept on the
patient, for example attached to a belt or kept in a pocket and is
responsible for keeping a log of the heart's electrical activity
throughout the recording period. The systems of the invention can
perform episodic monitoring, in which a particular event is
detected, either manually or automatically. An example of episodic
monitoring is a cardiac event-monitor. In episodic monitoring, the
.mu.-Base can control the .mu.-Patch, so that the patch performs
only minimal sensor signal processing to detect the particular
event, then monitors and stores physiological signals after event
detection. The radio-section of the Patch would generally be turned
off while waiting for the event. The systems of the present
invention can also perform periodic monitoring wherein the
.mu.-Patch measures and stores data related to physiological
signals at a given time interval. In some embodiments, the
.mu.-Base keeps track of the time intervals and instructs the
.mu.-Patch when to measure signals and store data. Examples of
periodic monitoring by the system of the present invention are
blood-pressure or blood-glucose-monitoring. The time period between
monitoring intervals for periodic monitoring can be from seconds to
days. Generally, the time period between monitoring intervals for
periodic monitoring is on the order of minutes to hours. For
example, periodic monitoring for blood pressure could be every 10
to 30 minutes, and periodic monitoring of blood glucose could be
every few hours.
[0154] In some embodiments, the systems of the present invention
can be used in stand-alone mode. In stand alone mode a .mu.-Patch
or .mu.-Gate will monitor and record sensor signals and store
sensor data in a local memory. Once the observation period is
completed, the stored data is transferred to a server-type machine
for further analysis.
Asymmetric Distribution of Processing
[0155] One aspect of the invention relates to systems and methods
in which the processing is distributed unequally or asymmetrically
over different chips that are designed to work together. In some
embodiments, the asymmetric system incorporates one or more
patch-ASIC chips and a base-ASIC chip. In other embodiments the
system also incorporates one or more gate-ASIC chips. All of these
chips are designed to work together. In general, the system is
designed such that the base-ASIC chip has more processing resources
and therefore carries out more processing than the patch-ASIC chip
or the gate-ASIC chip. In some embodiments, the base-ASIC chip will
take on most or all of the processing of a certain type, allowing
the system to function such that the patch-ASIC and/or gate-ASIC
can function effectively using less energy, allowing them to run on
small batteries for long periods of time without having to replace
or recharge the batteries or replace the patch or gate.
[0156] In one aspect, the base-ASIC chip has more resources to
implement the physical layer of the basic radio than the patch-ASIC
chip. The resources devoted to the physical layer of the base radio
include: the baseband signal processor, the data encoder/decoder,
and the radio frequency transceiver. In some cases, the base-ASIC
chip has more resources to implement media access control (MAC)
functions that allows data interface to the radio's physical layer
than does the patch-ASIC chip. In some cases the base-ASIC chip has
more resources to run algorithms to monitor the radio environment
and facilitate the coordination of multiple radios than the
patch-ASIC does. In some cases the base-ASIC chip has more
resources for multiple antenna signal processing to increase the
link reliability than does the patch-ASIC chip. In some cases, the
base-ASIC chip has more resources to supervise the proper
functioning of the overall radio link and network than the
patch-ASIC chip. In some cases the base-ASIC chip has more
resources for power management than the patch-ASIC chip.
[0157] In some embodiments, the base-ASIC chip has more processing
resources for one of the types of processing resources described
above. In some embodiments, the base-ASIC chip has more processing
resources for to 2, 3, 4 or more of the types of resources
described above than the patch-ASIC chip. In some embodiments, the
base-ASIC chip has more processing resources for all of the types
of resources described above. For example, in some cases, the
base-ASIC chip has more resources to implement the physical layer
of the basic radio, more resources to implement media access
control (MAC) functions that allows data interface to the radio's
physical layer, more resources to run algorithms to monitor the
radio environment and facilitate the coordination of multiple
radios, more resources for multiple antenna signal processing to
increase the link reliability and more resources to supervise the
proper functioning of the overall radio link and network than the
patch-ASIC chip.
[0158] In some embodiments, the base-ASIC chip has more processing
resources than the patch-ASIC chip because the base-ASIC chip has
higher complexity radio receivers and transmitters than those in
the patch-ASIC chip. A typical radio transmitter or receiver
generally contains three primary functions: Data Codec
(Coder/Decoder), Baseband signal processor, and Radio Frequency
(RF) transceiver. In some embodiments the base-ASIC chip has higher
more processing power in one, two, or all three of these functions
than the patch-ASIC chip. As used herein, a Data Codec
(Coder/Decoder) refers to the encoding of data to be transmitted on
the transmitter side to increase the system reliability. One
example of Data Codec is Turbo coding. Correspondingly, the
received data on the receiver side is decoded, for example, with a
Turbo Decoder. A baseband signal processor performs various
functions such as modulation/demodulation, equalization, and timing
recovery. On the transmitter side, a carrier wave is modulated
using a chosen scheme (e.g. QAM, BPSK) to produce a baseband signal
for the transmission. The receiver performs corresponding
demodulation functions on the received baseband signal. In addition
the receiver performs various other functions such as equalization.
A radio frequency (RF) transceiver transmits and receives radio
signals. The RF transmitter can modulate a RF carrier wave with
baseband signal for transmission through an antenna
(up-conversion). Simpler transmitters, generally used on the
patch-ASIC chip, can perform the up-conversion in one step and
complex schemes, such as those employed on the base-ASIC chip, may
include multiple steps with intermediate frequencies. On the
receiving end, the reverse process takes place--down-conversion of
the RF signal to baseband signal.
[0159] In addition, the radio can optionally contain additional
blocks. For example, the radio may contain a processor to monitor
the radio environment and coordinating the functionality of radios,
a multiple antenna signal processor, and power control. These
blocks can reside on the transmitter side, the receiver side or
distributed on both sides. For the systems and methods of this
invention, these blocks are generally contained mostly or
substantially completely on the base-ASIC chip.
[0160] The low complexity transmitter utilized on the patch-ASIC
chip performs the minimum needed functions form the above using
simple circuits. The patch-ASIC chip/base-ASIC chip system is
designed in order to push the complexity to the corresponding
receiver on the base-ASIC chip, making its functions more complex
(high complexity receiver). In this case, the silicon area of the
transmitter will be much smaller than the corresponding receiver.
The same strategy is applied to a pair of ASIC chips having high
complexity transmitter and a low complexity corresponding receiver.
The strategy also applies to a pair of high complexity and low
complexity transceivers (combined transmitter/receiver). For
example, in some embodiments, on one side, there is a
low-complexity transceiver, and on the other side, there can be
corresponding high complexity transceiver.
[0161] In some embodiments, Turbo encoding is performed on the
patch-ASIC chip, while turbo decoding is performed on the base-ASIC
chip. Typically, a turbo encoder complexity is exceedingly low
compared to that of a turbo decoder. A turbo encoder typically
encodes a data stream using two or more block or convolutional
encoders, and transmitting the coded bits in a multiplexed fashion.
One of the encoders encodes the data stream directly, while the
other encoders first interleave the data stream before encoding it.
The encoded bit streams are sometimes punctured by throwing away
certain bits before being multiplexed and transmitted. This is done
to meet channel data rate and bandwidth requirements.
[0162] The turbo decoder on the base-ASIC chip performs the inverse
function of a turbo encoder by decoding the received data stream to
recover the original data stream that is encoded on the transmit
side. In the process of decoding, the decoder is able to correct
errors introduced due to poor channel quality (fading, noise and
interference) during transmission. The turbo decoder usually
operates on soft-decision received bits, and iteratively decodes
the coded bits from each of the encoders, while feeding channel
quality information from one decoder (corresponding to one encoder)
to the other decoder (corresponding to the other encoder). The
turbo decoder typically uses a MAP (maximum a posteriori) algorithm
as part of the decoding process. At each successive iteration, the
additional channel quality information from one decoder helps
decode the encoded stream with the other decoder in a more reliable
fashion. At the end of a few iterations when high-level of
reliability is achieved, hard-decision bits corresponding to the
original data stream (input to the encoders on the transmit side)
are recovered. In the process of decoding, the turbo decoder
performs several stages of de-interleaving and re-interleaving of
the received and recovered data streams. Turbo encoding and
decoding is described in C. Berrou, A. Glaviex, and P.
Thitimajshima, IEEE Int. Conf. Commun., vol. 2, Geneva,
Switzerland, May 1993, pp. 1064-1070, and B. Vucetic, J. Yuan,
Kluwer Academic Publishers, 2000.
[0163] One aspect of the invention is a system comprising a
base-ASIC chip and a patch-ASIC chip designed to work together
wherein the base-ASIC chip has more silicon area than the
patch-ASIC chip. The silicon area of the base-ASIC chip is larger,
in general, because the base-ASIC chip has more processing
capability as described herein. In some cases the higher silicon
area of the base-ASIC chip is due, in large part, to the higher
amount of processing resources for the radio core on the base-ASIC
chip. In some embodiments, the ratio of the area of the base-ASIC
chip to the area of the patch-ASIC chip is greater than about 1.5.
In some embodiments, the ratio of the area of the base-ASIC chip to
the area of the patch-ASIC chip is greater than about 2. In some
embodiments, the ratio of the area of the base-ASIC chip to the
area of the patch-ASIC chip is greater than about 3. In some
embodiments, the ratio of the area of the base-ASIC chip to the
area of the patch-ASIC chip is greater than about 4. In some
embodiments, the ratio of the area of the base-ASIC chip to the
area of the patch-ASIC chip greater than about 5. In some
embodiments, the ratio of the area of the base-ASIC chip to the
area of the patch-ASIC chip greater than about 10. In some
embodiments, the ratio of the area of the base-ASIC chip to the
area of the patch-ASIC chip is greater than about 1.5, 2, 3, 4, 5,
6, 8, 10, 12, 15, 20, or greater than 20. In some embodiments the
ratio of the area of the base-ASIC chip to the area of the
patch-ASIC chip is in a range of about 1.5 to about 3. In some
embodiments the ratio of the area of the base-ASIC chip to the area
of the patch-ASIC chip is in a range of about 2 to about 3. In some
embodiments the ratio of the area of the base-ASIC chip to the area
of the patch-ASIC chip is in a range of about 2 to about 5. In some
embodiments the ratio of the area of the base-ASIC chip to the area
of the patch-ASIC chip is in a range of about 3 to about 8. In some
embodiments the ratio of the area of the base-ASIC chip to the area
of the patch-ASIC chip is in a range of about 4 to about 8.
[0164] The absolute area of the silicon will depend, for example,
on the type of processing which is used. For example, for 0.13
micron CMOS processing, the patch-ASIC chip can have a silicon area
of, e.g. of 2 mm.sup.2, 4 mm.sup.2, or 9 mm.sup.2, while the
base-ASIC chip can have a silicon area of, e.g. 4 mm.sup.2, 9
mm.sup.2, or 16 mm.sup.2.
[0165] The silicon area can be readily measured by measuring the
geometric (two dimensional) area of the ASIC chip. For a
rectangular chip, the area can be calculated by multiplying the
length of the height and width (not the depth) of the chip. For a
chip with irregular dimensions, the area can be easily be
determined by one of skill in the art.
[0166] One aspect of the invention is a method comprising a
base-ASIC chip and a patch-ASIC chip designed to work together
wherein the base-ASIC chip dissipates more power than the
patch-ASIC chip. An aspect of the invention is a method comprising:
monitoring a physiological condition using two or more ASIC chips
and a host device wherein the chips are designed to work together
to measure physiological signals comprising: (a) receiving signals
from a sensor at a patch-ASIC chip that is incorporated into a
physiological signal monitoring patch, the patch-ASIC chip
comprising a sensor interface coupled to the sensor, a processor
coupled to the sensor interface, a memory element coupled to the
processor, a radio coupled to the memory element; (b) transmitting
data signals from the radio on the patch-ASIC chip through an
antenna incorporated into the patch; (c) receiving the data signals
at a base-ASIC chip comprising an antenna that sends the signals to
a processor that processes data signals, a memory element coupled
to the processor, a radio coupled to the memory element, and a host
interface through which the base-ASIC chip communicates with a host
device; and (d) transmitting instructions wirelessly from the
base-ASIC chip to the patch-ASIC chip; wherein the base-ASIC chip
consumes more power than the patch-ASIC chip. Power is energy
transferred per unit time. Power is an instantaneous value, while
Energy relates to the amount of power used over time. Thus, when
the power dissipated by a chip of the present invention, the power
dissipation is generally measured over a period of time, in which
case, for example, the average power over that time period can be
determined. When calculated in this way, the ratio of average power
over time or the ratio of energy dissipated can be used. The power
dissipation of the base-ASIC chip is larger, in general, because
the base-ASIC chip has more processing capability as described
herein.
[0167] In some cases the higher power dissipation of the base-ASIC
chip is due, in large part, to the higher amount of processing
resources for the radio core on the base-ASIC chip. In some
embodiments, the ratio of the power dissipation of the base-ASIC
chip to the power dissipation of the patch-ASIC chip is greater
than about 1.5. In some embodiments, the ratio of the power
dissipation of the base-ASIC chip to the power dissipation of the
patch-ASIC chip is greater than about 2. In some embodiments, the
ratio of the power dissipation of the base-ASIC chip to the power
dissipation of the patch-ASIC chip is greater than about 3. In some
embodiments, the ratio of the power dissipation of the base-ASIC
chip to the power dissipation of the patch-ASIC chip is greater
than about 4. In some embodiments, the ratio of the power
dissipation of the base-ASIC chip to the power dissipation of the
patch-ASIC chip greater than about 5. In some embodiments, the
ratio of the power dissipation of the base-ASIC chip to the power
dissipation of the patch-ASIC chip greater than about 10. In some
embodiments, the ratio of the power dissipation of the base-ASIC
chip to the power dissipation of the patch-ASIC chip is greater
than about 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 20, or greater than
20. In some embodiments the ratio of the power dissipation of the
base-ASIC chip to the power dissipation of the patch-ASIC chip is
in a range of about 1.5 to about 3. In some embodiments the ratio
of the power dissipation of the base-ASIC chip to the power
dissipation of the patch-ASIC chip is in a range of about 2 to
about 3. In some embodiments the ratio of the power dissipation of
the base-ASIC chip to the power dissipation of the patch-ASIC chip
is in a range of about 2 to about 5. In some embodiments the ratio
of the power dissipation of the base-ASIC chip to the power
dissipation of the patch-ASIC chip is in a range of about 3 to
about 8. In some embodiments the ratio of the power dissipation of
the base-ASIC chip to the power dissipation of the patch-ASIC chip
is in a range of about 4 to about 8. The ratios are generally
measured when the patch-ASIC chip and base-ASIC chip are in
communication. In some embodiments the ratios are measured while
the patch-ASIC chip and base-ASIC chip are in continual data
transmission.
[0168] The absolute amount of power dissipated or energy used will
depend heavily on the type of process used and the implementation
of the radio system. In an implementation in CMOS process where two
radios are cooperating (a UWB radio and a narrowband radio), for
example, the patch-ASIC chip can dissipate about 1 mW, 4 mW, or 10
mW of power and the base-ASIC chip can dissipate about 2 mW, 8 mW,
or 20 mW of power.
[0169] The measurement of the amount of power dissipated or energy
used is understood by those of ordinary skill in the art. It is
understood that under normal operation, the ASIC chips are not
using power at a constant level. As used herein, the power
dissipation is generally measured while the radio is being used,
that is, while the patch-ASIC chip and base-ASIC chip are in
communication. The power numbers are generally mentioned for
continual data transmission from the patch-ASIC chip to base-ASIC
chip. The patch-ASIC chip power numbers include the power
dissipation in the following circuits: capturing the data from the
sensors, preprocessing of data to make it suitable for radio
transmission, radio, and driving the antenna. The reverse order
applies for the base-ASIC chip power. As used herein, the
"continual data transmission" can be, for example, the patch-ASIC
chip continually transmitting data from the sensors attached to it
to the corresponding base-ASIC chip with the following conditions:
(i) The source data rate of the sensor being of the order of 100
Kbits/sec, (ii) the wireless link reliability being very high in a
typical indoor environment where healthcare systems are deployed
(link reliability about 99.99%), and (iii) little to no loss of
sensor data The continual transmission time can range from a few
seconds to many days. For example, the transmission time can be
about 2, 5 10, 30 or 60 seconds, or, 2, 5, 10, 30, or 60 minutes,
or 2, 3, 6, 12, or 24 hours, or 2, 5, 10, 20, 30, 60 or 90
days.
[0170] In one aspect, the system includes a medical signal
processor which communicates with a wireless distributed sensor
system as its peripheral for detecting physiological parameters of
the person and for providing signals indicative thereof. The term
.mu.-Base as used herein is interchangeable with medical signal
processor or MSP. In one embodiment, the medical signal processor
wirelessly receives the signals from the distributed wireless
sensor system in a multiplexed fashion and processes the signals to
provide an indication of the health of the person. The indication
of health could relate to a disease state, general health or
fitness level of a person. In some embodiments, the system includes
a mobile device for receiving the indication of the health of the
person to allow for a diagnosis or treatment of the person, and a
secure server for securely storing the at least one indication of
health. The core processing resources of the medical signal
processor, for example the .mu.-Base allows wireless distributed
sensors to be ultra reliable/secure, ultra low power, ultra small
and low cost. The peripheral wireless sensors can be a within a
reasonable range of medical signal processor such as the base-ASIC
chip. In some embodiments, the sensors are within 1 to 3 meters for
example next to a bed in a hospital room. In some embodiments, the
sensors are within 1 to 10 meters for example within a room. In
some embodiments, the sensors are within 1 to 30 meters for example
within a typical home.
[0171] A distributed sensor based mobile/remote monitoring system
for the management of various types of diseases is disclosed. The
system is capable of continuously monitoring a variety of
parameters relating to the state of various diseases. The parameter
monitoring can be continuous, periodic or episodic. The system is
capable of continuous monitoring of given parameters from a few
seconds to many days. A system to manage a particular type of
disease or meet a health objective can be defined by selecting the
appropriate parameters for that disease. For example, an ECG can be
monitored on a patient in order to diagnose and prescribe
treatments for cardiac care.
[0172] The present invention relates generally to health monitoring
and more particularly to a health monitoring system that utilizes a
medical signal processor or .mu.-Base with a wireless distributed
sensor system. The following description is presented to enable one
of ordinary skill in the art to make and use the invention and is
provided in the context of a patent application and its
requirements. Various modifications to the preferred embodiments
and the generic principles and features described herein will be
readily apparent to those skilled in the art. Thus, the present
invention is not intended to be limited to the embodiments shown,
but is to be accorded the widest scope consistent with the
principles and features described herein.
[0173] To describe the feature of the medical signal processing
system in more detail, refer now to the following description in
conjunction with the accompanying figures.
[0174] FIG. 1A is an embodiment of a general architecture of a
wireless medical signal processing system 100 in accordance with
the present invention.
[0175] The system 100 is centered around a medical signal processor
104, such as a .mu.-Base that has a wireless distributed sensor
network as its peripheral. The distributed sensor network includes
a plurality of patches 102a-102n on a person 101. The patches
102a-102n can be internal to the body, coupled to the exterior of
the body embedded in the garments or can be in close proximity of
the body by some other means. In some embodiments, the patches
comprise a .mu.-Patch and a patch-ASIC chip. The patches
communicate wirelessly with MSP 104. In some embodiments, MSP 104
also includes its internal/local sensors 106, which can engage the
body of the person, which are also part of the distributed sensor
system. The medical signal processor (MSP) 104 in turn communicates
with a mobile device 108. The mobile device 108 in turn
communicates with a secure server 110 via a wireless or wired
network. In this embodiment, the MSP 104 is a separate component
from the mobile device 108. However, one of ordinary skill in the
art readily recognizes that the MSP 104 could be incorporated into
the mobile device as shown in FIG. 1B which is a second embodiment
of the system 100. The MSP 104 also includes sensors 106, which can
engage the body of the person, which are also part of the
distributed sensor network. The MSP 104 has the ability to absorb
significant processing burden from all of its distributed sensors
to form a reliable wireless link with them. The MSP 104 also has
the ability to communicate with all of its distributed sensors
through a wireless uplink. It allows the MSP 104 to use its
internal resources to monitor, control and dictate various
performance factors of the distributed sensors to achieve the
performance balance needed for any given application. The MSP 104
also can perform various house keeping functions for the overall
medical signal processing system.
[0176] The mobile device 108 could be, for example, a cellular
telephone, laptop, notebook, a smart phone, a PDA, a custom medical
device or any stationary, portable, or mobile device which can
communicate with the server over a network. Each component of the
health monitoring system 100 will now be described in detail in
conjunction with the accompanying figures.
Medical Signal Processing System
[0177] As discussed above, the medical signal processing system as
shown in FIGS. 1A and 1B can include a variety of sensors--either
directly integrated in the medical signal processor or .mu.-Base
104, or linked to the medical signal processor 104 via a wireless
link as patches 102 on the body of a user. Examples of various
sensors that can be included in the distributed sensor system are
shown in FIG. 2. Out of these examples, certain sensors can be
chosen for implementation as patches 102, comprising, for example a
patch-ASIC chip. Other sensors can be chosen for integration within
the MSP 104. In this way, a variety of systems can be designed for
the management of diseases, health and fitness, by choosing the
sensors that monitor the appropriate parameters associated with
target applications.
[0178] Modes of Operation: By using the distributed sensor network,
the system of FIGS. 1A and 1B can monitor parameters in different
ways. For example, by wearing patches on the body, the monitoring
and/or transmission can be done continuously--e.g. continuously
sensor data flowing from sensors in to the mobile device to the
secure server. Patches can also be used for periodic or episodic
monitoring. In some embodiments, the monitoring is done
continuously, but the transmission is done in bursts. This is
accomplished by using memory within the patch-ASIC chip to buffer
data by storing the data for later transmission. In some
embodiments, the data is stored in memory, and then regularly
transmitted in bursts, for example, every second, every 10 seconds,
every minute, every 2 minutes, every 5 minutes, every 10 minutes,
or every 30 minutes. By transmitting in this regular burst mode,
the patch can save energy over transmitting continuously because
transmitting takes energy, and spending less time transmitting
saves energy. The data transmitted in bursts is generally
transmitted at a higher rate than the rate of sampling. In some
embodiments, the data is stored in a buffer during a time period
during which the patient wearing the patch is farther away from the
.mu.-Base. This embodiment allows for energy to be conserved in the
patch in the present invention due to the ability of the .mu.-Base
to control the transmission mode of the patch. For example, the
.mu.-Base can control the power at which the patch transmits data
or the mode of transmission. The .mu.-Base can instruct the patch
to store incoming data while the patch is farther away when it
would take higher power and more energy to transmit, and later
instruct the patch to send the data at lower power when the patch
is closer to the .mu.-Base.
[0179] In some cases, the system is used in stand-alone mode. In a
stand-alone mode, monitoring is normally done in an episodic or
periodic mode by using the MSP 104 and sensors 106. For example, a
cardiac rhythm can be directly monitored by pressing the MSP 104
against the body by using a built in ECG sensor. Another example of
this stand-alone mode is glucose, cholesterol or blood coagulation
monitoring. A drop of blood can be placed on a biochemical sensor
that is built into the MSP 104 which can be converted to electrical
signal by MSP for further processing. The glucose, cholesterol or
blood coagulation rate reading will be registered in the sensor
database on MSP 104 and/or mobile device 108 and/or the secure
server 108.
Wearable Wireless Patches 102
[0180] Patches 102 are integrated circuit technology driven
miniature wireless devices that can be conveniently attached to the
body. Patches can also be designed for implanting within the body
of a person. To achieve compactness, the patches 102 can be
designed using a custom ASIC (a patch-ASIC chip) and a compact
multi-chip module. The patches can be further simplified by
leveraging the resources of MSP 104. The patch 102 in a preferred
embodiment has two main parts: sensor circuits, and a radio core
for the transmission of sensor data to other devices. In addition,
it has a signal processor and power management circuits to achieve
very low power dissipation. The sensor circuits can be directly
incorporated in the custom ASIC and/or patch can also include a
standalone sensor device whose data can be transmitted to other
devices using the radio or ASIC on the patch. In a preferred
embodiment, a person can wear a patch 102 for several days for
continuous monitoring without changing or recharging the power
source. Patches 102 can have the ability to receive wireless
signals from the MSP 104 .mu.-Base to enhance its own power
dissipation and improve its own wireless link reliability, based on
the MSP's 104 monitoring of radio environment and application
requirements. The patches 102 can also receive test/control signals
from the MSP 104 to get authenticated and to check its own
functionality.
[0181] FIG. 3 illustrates a wireless patch 102 utilized in
accordance with the present invention. The wireless patch 102
receives signals from a body sensor 202 via a sensor interface 204.
The patch 102 may receive signals from a body it is either in
contact with, or in close proximity of. The sensor interface 204
can receive electrical signals or other signals representative of
different physiological parameters of the body. The output from the
sensor interface 204 is provided to a processor 208 which processes
the signal to perform various functions such as compression to
reduce the data rate, encoding to achieve high reliability and
manage buffering to vary duty cycle of radio. The processed data is
presented to a storage element 214. The data from the storage
element 214 is provided to a radio 210 which outputs the signal to
a signal antenna 212. The storage element 214 can be adapted to be
coupled to a local display/alert 216. A power source 209 provides
power and power management to all elements of the patch 102. As
shown, a wireless path through radio/antenna 210/212 also exists to
receive test and control signals from the MSP 104 as discussed
above. As shown, all resources of the patch 102 can be controlled
by the MSP 104 by a signal C, wirelessly coming to patch 102 from
the MSP 104.
[0182] Accordingly, by leveraging the information sent by MSP 104
via signal C, patches can dynamically alter the performance of
their various functional blocks to choose trade off among high
reliability, high security, low power and low cost for given
applications of health monitoring.
[0183] FIG. 3A illustrates another embodiment of a wireless patch
comprising a .mu.-Patch and a patch-ASIC. The wireless patch 102
comprises a patch--ASIC 120 which receives signals from either
external analog sensors 220 or built in sensors 221 via a sensor
interface 204 which has an analog to digital converter (ADC). The
patch-ASIC 120 can also receive signals from digital sensors 222
that can that can be sent via the a sensor bus to the processor
without passing through the sensor interface 204. The sensor
interface 204 can receive electrical signals or other signals
representative of different physiological parameters of the body.
The output from the sensor interface 204 is provided to a processor
208 which processes the signal to perform various functions such as
compression to reduce the data rate, encoding to achieve high
reliability and manage buffering to vary duty cycle of radio. The
processed data is presented to a storage element 214. The data from
the storage element 214 is provided to a radio 210 via radio
interface 207 which outputs the signal to a signal antenna 212. The
processor 208 can be adapted to be coupled to a local display/alert
216. A power management circuit 209 connects to the processor 208
and exerts control over the elements of the patch to control the
power that is supplied by a battery external to the .mu.Patch. A
wireless path through radio interface 207, radio 210 and antenna
212 also exists to send data to the .mu.-Base (MSP) 104 and to
receive test and control signals from the .mu.-Base (MSP) 104 as
discussed above. Here, the antenna 212 resides outside of the
patch-ASIC 120 and is attached to a PCB on the .mu.-Patch along
with the patch-ASIC. As shown, all resources of the patch 102 can
be controlled by the MSP 104 by a signals received through the
antenna. The patch-ASIC 120 can also have an encryption processor
225 having an AES, CRC, and/or FEC coprocessors connected to the
processor 208 for signal encoding and/or decoding. In some
embodiments the encryption processor on the patch-ASIC has only
circuits for encoding but not decoding circuits.
[0184] In summary, the trade off is possible due to any of or any
combination of the following features:
[0185] a. A sensor interface to connect to a variety of
physiological sensors
[0186] b. A radio subsystem that can support a variety of
communication schemes (e.g. different modulations including analog
modulation, various codings, various data rates) to wirelessly
communicate with a medical signal processor which is within a
reasonable range, such as within a typical house
[0187] c. A processor to support a variety of wireless
communication schemes for radio system
[0188] d. A processor that can implement various authentication and
security schemes as desired by application
[0189] e. Means to wirelessly receive a variety of test signals
from a medical signal processor
[0190] f. Means to run test signal though its data paths and
generate output signals in response
[0191] g. Means to wirelessly send resulting output signals back to
medical signal processor
[0192] h. Means to receive various control signals to reconfigure
its various functional blocks
[0193] i. Reconfigurable internal blocks to alter data rates, radio
scheme, communication algorithm, power dissipation levels, etc.
[0194] j. sensors that can receive body's electrical physiological
signals
[0195] k. Encapsulation in a packaging material that can also
provide a body interface
[0196] l. Using its radio, generation of a RF beam that can be
directed towards a part of person's body to probe internal
parts
[0197] m. Means to receive the RF signals scattered by body that
can be analyzed to get information about the internals of the
body
[0198] n. Means to bring the device in a close proximity of
body
[0199] o. Means to attach the device to body
[0200] p. Means to analyze and display the sensor data
[0201] q. Means to alert a person as needed
[0202] r. For ultra high reliability, ability of patches to
wirelessly communicate with each other in case of loss of link by a
patch to medical signal processor
Medical Signal Processor (MSP) 104 (.mu.-Base)
[0203] The medical signal processor (MSP) 104 collects and receives
data from the one or more of the distributed sensors (internal or
external), and aggregates and processes this data. In addition, the
MSP 104 can reliably transmit it to mobile device 100 in such a way
that mobile device 100 in turn can transmit the data to a remote
server system over wireless, cellular, or any type of wide area
network (WAN).
[0204] The MSP 104 may have one or more of the following
features:
[0205] 1. to collect data from its internal/local sensors
[0206] 2. radio/processors to receive data from external wireless
sensors that are within a reasonable range, such as within a
typical house
[0207] 3. means to process and aggregate the sensor data based on
an algorithm that can be programmed in MSP 104 to determine a
diseases state and/or health state and/or fitness state
[0208] 4. means to attach or connect or plug in to a mobile
device
[0209] 5. means to generate an alert based on the determination of
the state of disease, health or fitness
[0210] 6. means to locally display collected raw sensor data or
processed data
[0211] 7. means for transmission of collected raw sensor data or
processed data to a remote server either directly or via a mobile
device
[0212] 8. means to enable continuous reliable transmission of
sensor data over a cellular or wide area network
[0213] 9. user interface to control the operation of monitoring
system
[0214] 10. means of a regular cell phone device (voice, data and
image communication, display, keypad, etc.)
[0215] In addition to collecting and processing the data from all
of its peripheral patches/sensors, the MSP 104 also has various
means to wirelessly monitor and control all of its peripheral
patches/sensors through a wireless uplink with them. Essentially,
the MSP 104 becomes an integral part of the wireless medical signal
processing system to achieve the overall requirements of the
system--a major requirement being patches to be ultra
reliable/secure, ultra low power, ultra small and low cost. The
overall functionality of the system is asymmetrically partitioned
between the patches 102 and MSP 104 to achieve these critical patch
requirements.
[0216] Accordingly, MSP 104 may have the following features to
achieve the system objectives:
[0217] 1. means to act as a master of the overall system and
patches/sensors to be its slaves
[0218] 2. means to manage a distributed network of
patches/sensors
[0219] 3. means to authenticate, test and control the functionality
of all of its peripheral patches/sensors
[0220] 4. means to monitor/dictate the wireless link performance of
its peripheral patches/sensors
[0221] 5. means to monitor/dictate the power dissipation of its
peripheral patches/sensors
[0222] 6. means to dictate the degree of reliability of all of its
peripheral sensors/patches
[0223] 7. means to allow peripheral sensors/patches to use a very
simple radio and have its own signal processor to complete the
radio processing for patches/sensors
[0224] 8. means to recreate the original sensor data if data has
been compressed on the sensor/patches
[0225] 9. means to monitor radio environment.
[0226] 10. Radio to work with multiple communication schemes
including digital and analog modulation
[0227] The MSP (.mu.-Base) 104 can control the functionality and
performance of its peripheral/patches based on the requirement
defined for the overall system. The system performance can be
dynamically adjusted, for example, due to a change in radio
environment or a change in person's condition as monitored by the
MSP 104.
[0228] FIG. 4 illustrates an MSP (.mu.-Base) 104 in accordance with
the present invention. An antenna 301 and a radio 302 within the
MSP 104 receives a plurality of data signals (signals A-N) from the
distributed sensor network. The radio 302 then provides these
signals to a signal processor 304. The processor 304 then decodes
the signals received by the radio 302. The decoded signals are then
provided to a smart signal combiner 306, in a multiplexed or
parallel fashion.
[0229] The smart signal combiner 306 includes a means for
programming an algorithm for combining the signals to provide an
indication of a state of the body. For example, certain sensor
parameters taken together might indicate a disease state and/or
heath state and/or fitness state of an individual.
[0230] The smart signal combiner 306 may also receive a signal Y
from the local sensors 106 in the MSP 104. The signal Y represents
either one signal from one local sensor or a plurality of signals
from a plurality of local sensors. The smart signal combiner 306
also provides a signal (X) that is a parameter, relating to a state
that has been measured utilizing a single sensor output or by
combining the outputs of multiple sensors. This state is a result
of one or several physiological parameters of the body and the
signal X may be a function, computed over time, of one, all or a
set of those sensor outputs (signals A-N) and sensor signals.
[0231] These various signals (A, B, . . . N, Y, X) are provided to
a storage element 308 by the smart signal combiner 306. The storage
element 308 may be any type of memory that can be utilized in
integrated circuits. The storage element 308 can be adapted to be
coupled to a local display/alert device 311 via the sensor
interface 313. The data can then be retrieved by the mobile device
from the storage element 308 via a bus interface 310. As before
mentioned, the MSP 104 can either be part of the mobile device 108
or a stand alone device.
[0232] All these resources enable MSP 104 to act as a stand-alone
device to provide the needed information locally to concerned
parties or it can transmit the information to a remote secure
server for further processing and access. The information can be
used locally, or remotely, to diagnose/treat a disease or for
general health/fitness management of a person. As shown, MSP 104
also has a wireless path to communicate with patches/sensors to
monitor and control their performance. In a control mode, radio 302
operates in an uplink mode by sending test/control data via signal
P over the wireless link. This control mode is activated when the
MSP 104 needs to test, monitor and/or control its peripheral
patches/sensors via the processor 304. The processor 304 should be
for example, a microprocessor with signal processing capability
that executes the various functions.
[0233] The processor 304 can utilize other resources such as smart
signal processor 306 and storage 308 to carry out its control/test
related and general processing tasks. In the control mode, for
example, the processor 304 can generate test signals and send to a
patch 102, and analyze the signals received from the patch 102 to
estimate its wireless link performance. If needed, the MSP 104 can
then send control signals to alter the wireless link performance by
changing certain parameters relating to radio functions of the
patch 102, for example by instructing signal processor 208 and
radio 210. In some implementations, some of the internal blocks of
MSP 104, such as processor 304, smart signal processor 306 and
storage 308 can be implemented in software. This implementation is
likely when MSP 104 functionality is embodied within a mobile
device, computer, a custom medical device, or any other device.
[0234] FIG. 4A illustrates another embodiment of an MSP (.mu.-Base)
104 of the present invention. The .mu.-Base 104 comprises a
base-ASIC 130. An antenna 301 is connected to the base-ASIC 130
through a PCB to which the base-ASIC 130 and antenna 301 are also
attached. The antenna sends signals to the radio 302 that it
receives data from the patch 102. The radio 302 then provides these
signals to a signal processor 304 through radio interface 307. The
processor 304 then decodes and can further process the signals
received by the radio 302. The processor can send the data to
storage element 308. The data can then be retrieved from storage
element 308 and sent to a host device 150 (which could, for
example, be a mobile device 108) through the host interface 310. As
shown, MSP 104 also has a wireless path to transmit to with
patches/sensors to monitor and control their performance. In a
control mode, radio 302 operates in an uplink mode by sending
test/control data over the wireless link. This control mode is
activated for the MSP 104 to test, monitor and/or control its
peripheral patches/sensors/gates via the processor 304. The
processor 304 should be for example, a microprocessor with signal
processing capability that executes the various functions. In the
control mode, for example, the processor 304 can generate test
signals and send to a patch 102, and analyze the signals received
from the patch 102 to estimate its wireless link performance. If
needed, the MSP 104 can then send control signals to alter the
wireless link performance by changing certain parameters relating
to radio functions of the patch 102, for example by instructing
signal processor 208 and radio 210. The base-ASIC 130 also has the
capability of receiving signals from external analog sensors 320 or
local analog sensors 321 to processor 304 through sensor interface
313. The base-ASIC can also receive signals from digital external
sensors 322 to the processor 304. The base-ASIC 130 can also have
an encryption processor 325 having for example AES. CRC, and/or FEC
coprocessors connected to the processor 208 for signal encoding
and/or decoding. In addition, as shown, the processor 304 is
connected to a digital signal processing chip (DSP) 326 through a
coprocessor bus for performing smart antenna protocols such as
beam-forming or for processor intensive decoding algorithms. A
power management circuit 309 connects to the processor 304 and
exerts control over the elements of the patch to control the power
that is supplied by a power supply external to the MSP.
[0235] The functionality of MSP 104 allows its distributed sensors
(patches) to maintain high wireless reliability, high security, low
power and low cost. Furthermore, the versatility of MSP 104 allows
it to create a variety of different types of medical systems. To
allow this functionality and versatility, in summary, it can
include any of or any combination of the following features:
[0236] a. Means to wirelessly communicate with a plurality of
peripheral wireless physiological sensors in a multiplexed fashion
that are within a reasonable range, such as within a typical
house
[0237] b. Means to manage a network of plurality of said sensors as
their master
[0238] c. Means to display health state information or the data
received from peripheral sensors
[0239] d. Means to alert a person about health state
[0240] e. Means to connect to a mobile device to exchange
information with it and to communicate with a remote server through
mobile device's connectivity to a wide area network
[0241] f. Partitioning of its functions between hardware and
software to allow its integration within a mobile device
[0242] g. Means to wirelessly send a variety of test signals to its
peripheral sensors and analyze the received signals to monitor the
proper functioning of the sensors and their various internal
functional blocks
[0243] h. Means to send various control signals to peripheral
sensors to configure their various functional blocks:
[0244] i. Means to monitor peripheral sensors to determine their
respective power dissipation rates and the state of their power
sources; to supervise power management
[0245] j. Means to monitor surrounding radio environment to
determine an optimum wireless communication scheme at any given
instance
[0246] k. Means to instruct peripheral sensors to utilize a
particular radio/communication mode for reliable operation
[0247] l. Means to authenticate peripheral sensors
[0248] m. Means to monitor various security aspects of peripheral
sensors
[0249] n. Means to allow coupling to local sensors through a wired
connection
[0250] o. A processor to support the execution of a variety of
communication algorithms/schemes to allow peripheral sensor to use
the simplest possible communication scheme for a given application
to minimize sensor's power and resource requirements by absorbing
the burden of processing (asymmetric communication scheme)
[0251] p. A smart signal combiner that can be programmed to run
needed algorithms to (i) analyze signals from one or more
peripheral sensors over time, and/or (ii) combine signals from a
plurality of peripheral sensors; to determine a health state
[0252] q. Storage media to store the health state information
and/or raw data received from peripheral sensors
Mobile Device 108
[0253] The mobile device 108 could be, for example, a cellular
telephone, laptop, notebook, a smart phone, a PDA, a custom medical
device or any mobile device which can communicate with the server
over a wide area network and/or Internet. The mobile device 108 can
also be a regular cell phone handset, which has been modified to
include the appropriate features and means to work with MSP 104.
The mobile device 108 communicates with the MSP 104. In one
embodiment, the MSP can be built within mobile device 108 as part
of the mobile device design. In this mode, many internal functions
of MSP can be implemented in software. In most cases, MSP's radio
system and sensor interfaces will remain intact in hardware.
Secure Server 110
[0254] The secure server 110 receives data from distributed sensors
over a cellular telephony network, any type of wide area network or
Internet via MSP 104 and the mobile device 108. The server 110
further processes the received data from the mobile device and
stores it in a secure location. The server 110 may also contain
various types of software programs, including software to manage
health information databases (such as electronic medical records,
computerized purchase orders and computerized prescription
systems). The secure server 110 may also have the middleware to
process/link sensor data to such health information databases.
[0255] The data stored on the secure server 110 may be accessed by
a healthcare provider, caregiver or patient via the Internet by
using any type of terminal device such as computer, mobile device,
cell phone, smart phone or personal data assistant (PDA).
[0256] The health monitoring system in accordance with the present
invention supports many classes of sensors for physiological data
collection, such as:
[0257] 1. The health monitoring system supports many classes of
sensors for physiological data collection, such as:
[0258] a. Sensors (either patches 102 or sensors 106) contacting
the body 101 through gels, etc.
[0259] b. Patches 102 embedded within the body 101 through surgical
procedures.
[0260] c. Patches 102 probing the body 101 through micro-needle
based skin punctures.
[0261] d. Sensors in close proximity of the body 101 -e.g., probing
using a microwave or optical beam.
[0262] e. Sensors embedded in the MSP 104 or mobile device 108 for
periodic or occasional use.
[0263] f. Sensors that can read biochemical micro-fluidic test
strips (e.g. glucose, blood coagulation rate) via electrical or
optical sensor
[0264] 2. The health monitoring system in accordance with the
present invention can support one of these sensors and/or patches
or multiple sensors and/or patches from multiple classes.
[0265] 3. The MSP 104 has the ability to collect data in real time
from many such sensors and/or patches and to apply a chosen
algorithm to combine signals from various sensors and/or patches to
determine or predict a physiological or disease state.
[0266] 4. The MSP 104 can store data for local use and/or transmit
in real time to a remote server for use by clinicians and other
parties. If desired, some of the MSP 104 functions can be
implemented on a remote sensor.
[0267] 5. As stated above, one function of the MSP 104 is
physiological data processing.
[0268] 6. The second function of MSP 104 is to manage all patches
and/or sensors for optimal functionality--managing
authentication/security functions, monitor and enhance the radio
transmission performance of patches and/or sensors to increase link
reliability, monitor and minimize power dissipation by patches
and/or sensors.
[0269] The health monitoring system in accordance with the present
invention can be utilized in a variety of environments. One example
is the cardiac disease management system. To describe the features
of such a system refer now to the following description in
conjunction with the accompanying figures.
A Mobile/Remote Monitoring System for Cardiac Disease
Management
[0270] An embodiment of a cardiac disease care product in
accordance with the present invention is described herein below.
FIG. 5 is a block diagram of a cardiac care product in accordance
with the present invention. The cardiac care product includes a
mobile device 504 which utilizes patches 102'' and biostrips as
sensors 510. The mobile device 504 includes an ECG event recorder
502, a geographic positioning system (GPS) and health utilities.
The patches may include a Holter mechanism and a loop ECG monitor
506 as well as accelerometers for detecting physical activity. The
biostrips 510, which are basically microfluidic test strips, may be
utilized, for example, for anticoagulation analysis of the blood
(PT/INR).
[0271] FIG. 6 is a block diagram of one implementation of a mobile
device utilized with the cardiac care product of FIG. 5. The mobile
device 504 may receive a first SD (Secure Digital) card 602 that
includes wireless real-time monitoring system. The SD card 602
receives data from patches 102'''' and other sensors. The mobile
device 504 also may receive a second SD card 604 that monitors
PT/INR, glucose and the like. The second SD card receives its data
via biostrips 606 that can be activated by a drop of patient's
blood, for example. The PT/INR and/or glucose reading is obtained
by building an electrical or optical reader on the second SD card
that can read the biostrips. The cardiac care product can be used
for the management of various cardiac diseases, including
arrhythmia. In an embodiment, this cardiac care product monitors
the following parameters:
[0272] 1. ECG signals (time duration programmable--few seconds to
few weeks)
[0273] 2. Pulse and respiration
[0274] 3. Patient's physical movement
[0275] 4. Blood coagulation analysis for drug therapy for the
treatment of arrhythmia
[0276] 5. A mobile, integrated system for remote cardiac care is
provided--It is a system that is useful for diagnosis and treatment
of various cardiac diseases.
[0277] 6. Its core functions are listed below:
[0278] a. Wireless AECG--duration programmable from a few seconds
to 30 days to serve a variety of functions including Holter
monitoring, cardiac event monitoring, cardiac loop monitoring
(wireless ECG sensor patches and receiver)
[0279] b. PT/INR based blood anticoagulation analysis (dry
chemistry microfluidic strip and optical/electrical
reader/sensor)
[0280] 7. Its auxiliary functions are listed below:
[0281] a. Patient activity recording (accelerometer sensor)
[0282] b. Patient location information (GPS)
[0283] c. Ability to connect to an implanted wireless pacemaker
[0284] d. Medication schedules (software)
[0285] e. Doctor visit and treatment schedule (software)
[0286] 8. Microfluidic biostrip/reader concept can also be used for
glucose monitoring
[0287] 9. The system can be built by integrating the electronics
inside a mobile device/computer or an attachment to a mobile
device/computer. The mobile device 504 may or may not be connected
to a remote server through a network.
[0288] The sensors for parameter monitoring may be distributed
between the patches 102'''' and the mobile device 504 as
follows:
Patches 102
[0289] The patches 102'''' have sensors to continuously monitor
ECG, pulse, respiration and patient's physical movement. ECG
function can be programmed to work in any mode as prescribed by a
physician, such as:
[0290] a. Continuous ECG: for any amount of time (e.g. 24 Hrs, 48
Hrs, seven days, thirty days).
[0291] b. ECG Loop recorder: Shorter time recordings with
continuous overwriting
[0292] Patient's physical movement data is recorded along with ECG
data on a continuous basis. In addition, pulse and respiration are
recorded as desired.
MSP 104
[0293] In a stand-alone mode, the mobile device 504 has the means
to monitor a few different parameters as below:
[0294] a. ECG Event Recording: Via built-in ECG sensor, mobile
device 504 is able to record ECG signals for any duration as
desired. In this mode, the mobile device 504 is directly held to
the body 101.
[0295] b. Biochemical parameters: The mobile device 504 has a built
in biochemical sensor, electrical sensor and an optical sensor. Any
of these sensors can be used to read certain parameters relating to
disease management. For example, the MSP 104 can register blood
coagulation readings for PT/INR (Prothrombin Time/International
Test Ratio) analysis for Warfarin drug therapy. For this
application, a test strip with a blood drop mixed with a chemical
reagent can be inserted into the MSP 104 to determine blood
anticoagulation rate for PT/INR analysis.
[0296] A distributed sensor based mobile/remote monitoring system
for the management of various types of diseases is disclosed. The
system is capable of continuously monitoring a variety of
parameters relating to the state of various diseases. The parameter
monitoring can be continuous, periodic or episodic. Some of the
parameters that can be monitored by the system are ECG
(electrocardiograph), EEG (electroencephalograph), EMG
(Electromyography), blood glucose, pulse, respiration, blood
pressure, temperature, SpO.sub.2, body fluid density, blood
density, patient physical movement and patient physical location. A
system to manage a particular type of disease can be defined by
selecting the appropriate parameters for that disease. The system
can be applied to manage many type of diseases and conditions, such
as--arrhythmia, heart failure, coronary heart disease, diabetes,
sleep apnea, seizures, asthma, COPD (Chronic Obstructive Pulmonary
Disease), pregnancy complications, wound state, etc.
[0297] An innovative technology base is needed to address wide
ranging applications and to meet critical requirements for the mass
market--high reliability, high security, low power, small form
factor and low cost. The technology disclosed meets this goal. The
technology involves a medical signal processor (MSP) closely
supervising all aspects of functionality of its peripheral wireless
patches to help achieve the objectives. The patches are simple
while the medical signal processor (MSP) has all the smarts to work
with patches. It results in asymmetric processing load on MSP and
patches--patches are simple and reconfigurable and MSP has the
complexity to take the processing burden from them for wireless
communication link, and processing load to supervise patches. Both
the MSP and the patches have various resources to build complete
self contained systems to determine a health state of a person from
sensor physiological data and to display and/or send data to
another device for further processing.
[0298] One aspect of the invention is a method for monitoring a
physiological condition using two or more ASIC chips and a host
device wherein the chips are designed to work together to measure
physiological signals, wherein (a) one of the chips is a patch-ASIC
chip incorporated into a physiological monitoring patch comprising
a sensor interface for measuring physiological signals, a processor
for processing the signals into sensor data, memory for storing
data relating to the signals, a radio for transmitting sensor data,
and power management circuits for controlling power on the chip;
and (b) one of the chips is a base-ASIC chip comprising a processor
for processing sensor data, memory for storing data relating to the
signals, a radio for transmitting instructions to the patch-ASIC
chip, power management circuits for controlling power on the chip,
and a host interface allowing the base-ASIC chip to communicate
with the host device; wherein the base-ASIC chip controls a
function of the physiological signal monitoring patch.
[0299] Some embodiments of the method are methods to manage a
patient's disease. They types of diseases that can be managed
include arrhythmia, heart failure, coronary heart disease,
diabetes, sleep apnea, seizures, asthma, COPD, pregnancy
complications, and wound state.
[0300] Some embodiments of the method are methods to manage a
condition related to the wellness and fitness of a person. The
types of conditions that can be managed include weight loss,
obesity, heart rate, cardiac performance, dehydration rate, blood
glucose, physical activity or calorie intake, or combinations
thereof.
[0301] One aspect of the invention is method for unsupervised
placement of a physiological patch that involves: (a) placing the
patch that can receive wireless signals from a base device wherein
the patch comprises a visual marker to help the user orient the
patch on the patient's body; (b) initializing the patch with a base
device by automatic verification of proper placement of the patch;
and (c) indicating the proper or improper placement of the patch to
the user with an audio or visual indication. The indication of
proper placement can be provided by an audio or visual signal
either on the patch, on the base device, on the host device, or on
another device.
[0302] One aspect of the invention is a business method relating to
the production and use of sets of ASIC chips that are designed to
work together to measure physiological signals. The business method
involves manufacturing both a patch-ASIC chip and a base-ASIC chip
that are designed to work together to wirelessly communicate
physiological data, wherein each chip each comprises a processor,
memory storage, a radio, and circuits for power management. In some
embodiments, the chips are designed to be used with a plurality
sensor types. The method comprises selling and/or licensing the
patch-ASIC chip and base-ASIC chip to multiple customers for
incorporation into physiological sensing systems. This business
model contemplates the value of selling a chip set that can be used
in multiple types of physiological monitoring applications. The
fact that the chips are designed to work together to conserve
energy and to maximize communication provides value to the system
manufacturer and the end user. The fact that the chips can be used
in multiple applications allows the volume of ASIC chip
manufacturing to be high enough to provide to provide the economy
of scale to make the ASIC devices cost effective. The plurality of
sensor types include sensors that measure ECG, EEG, EMG, SpO.sub.2,
tissue impedance, heart rate, and accelerometer signals.
[0303] The business methods can be applied to sensor systems for
monitoring a patient disease or for monitoring health and fitness
conditions as described above.
[0304] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
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