Note: Descriptions are shown in the official language in which they were submitted.
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CONNECTOR FOR DETACHABLE ARRAY
CROSSREFERENCE TO RELATED APPLICATIONS / INCORPORATION BY REFERENCE STATEMENT
[0001 ]This application is a non-provisional application claiming benefit to
U.S. Provisional
Application No. 63/085,733, filed September 30, 2020. The entire contents of
the above-
referenced provisional application is hereby expressly incorporated herein by
reference.
BACKGROUND
[0002]TTFields therapy is a proven approach for treating tumors. For example,
using the
Optune system for delivering tumor treating fields (i.e., TTFields), the
TTFields are delivered to
patients via four transducer arrays placed on the patient's skin in close
proximity to a tumor. The
transducer arrays are arranged in two pairs, and each transducer array is
connected via a multi-
wire cable to an electric field generator. The electric field generator (a)
sends an AC current
through one pair of arrays during a first period of time; then (b) sends an AC
current through the
other pair of arrays during a second period of time; then repeats steps (a)
and (b) for the duration
of the treatment.
SUMMARY OF THE INVENTION
[0003] A need exists for an apparatus and method for imposing electric fields
through a target
region in a body of a patient. Disclosed herein is an apparatus for imposing
electric fields through
a target region in a body of a patient, which apparatus comprises: at least
one transducer array
having a plurality of electrode elements configured for placement on the body
of the patient,
the electrode elements configured to provide TTFields; and a connector
electrically connected
to the at least one transducer array, wherein the connector has at least one
associated
monitoring circuit configured to provide feedback related to a status of the
connector.
[0004] A method for monitoring an apparatus for imposing electric fields
through a target region
in a body of a patient is herein disclosed, the method comprising:
electrically connecting a
connector to at least one transducer array, wherein the at least one
transducer array has a
plurality of electrode elements configured for placement on the body of the
patient, the
electrode elements configured to provide TTFields; circulating current through
at least one
indicator pin integrated into a first portion of the connector, and an
associated indicator socket
connector integrated into a second portion of the connector; monitoring data
from the
circulating current; determining status of the connector based on the
monitored data; and,
providing a predetermined action based on the status of the connector.
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[0005] A system is herein disclosed, the system comprising: a plurality of
transducer arrays each
having substrate supporting a plurality of electrode elements configured for
placement on a
body of a patient, the electrode elements configured to provide TTFields and
at least one
electrode element associated with a temperature sensor; each transducer array
electrically
connected to a first side of a connector, and each transducer array comprising
a distal circuit
electrically coupled to each of the plurality of electrode elements of the
transducer array and
operable to receive a temperature signal from each of the associated
temperature sensors and
operable to output a DATA signal and to receive a TTField Signal, the distal
circuit being either
supported by the substrate, or integrated into the first side of the
connector, or both, or
positioned in a circuit between the transducer array and the connector, the
connector further
comprising a plurality of pins or socket connectors in electrical
communication with the
transducer array; and, at least one monitoring circuit configured to provide
feedback related to
a status of the connector; a hub electrically coupled to each of the plurality
of transducer arrays;
and an electric field generator electrically coupled to the hub and operable
to receive one or
more DATA signal and output one or more TTField Signal.
[0006] An apparatus for imposing electric fields through a target region in a
body of a patient is
herein disclosed, the apparatus comprising: at least one transducer array
having a plurality of
electrode elements configured for placement on the body of the patient and at
least one
temperature sensor, the electrode elements configured to provide TTFields; a
distal circuit
electrically coupled to the at least one transducer array and operable to
receive a temperature
signal from the at least one temperature sensor; and a connector electrically
connected to the
distal circuit, the distal circuit positioned in a circuit between the
transducer array and the
connector.
[0007] A system is herein disclosed, the system comprising: a plurality of
transducer arrays each
having substrate supporting a plurality of electrode elements configured for
placement on the
body of a patient, the electrode elements configured to provide TTFields and
at least one
electrode element associated with a temperature sensor; each transducer array
electrically
connected to a first side of a connector, and each transducer array comprising
a distal circuit
electrically coupled to each of the plurality of electrode elements of the
transducer array and
operable to receive a temperature signal from each of the associated
temperature sensors and
operable to output a DATA signal and to receive a TTField Signal, the distal
circuit being either
supported by the substrate, or integrated into the first side of the
connector, or both, or
positioned in a circuit between the transducer array and the connector; a hub
electrically
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coupled to each of the plurality of transducer arrays; and an electric field
generator electrically
coupled to the hub and operable to receive one or more DATA signal and output
one or more
TTField Signal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008]The accompanying drawings, which are incorporated in and constitute a
part of this
specification, illustrate one or more implementations described herein and,
together with the
description, explain these implementations. The drawings are not intended to
be drawn to scale,
and certain features and certain views of the figures may be shown
exaggerated, to scale or in
schematic in the interest of clarity and conciseness. Not every component may
be labeled in
every drawing. Like reference numerals in the figures may represent and refer
to the same or
similar element or function. In the drawings:
[0009] FIG. 1 is a block diagram of an exemplary system for measuring the
temperature of
transducer arrays applying TTFields to a body of a patient in accordance with
the present
disclosure.
[0010] FIG. 2 is a schematic diagram of an exemplary hub for use in the system
illustrated in FIG.
1 in accordance with the present disclosure.
[0011]FIG. 3 is a schematic diagram of an exemplary distal circuit for use in
the system
illustrated in FIG. 1 in accordance with the present disclosure.
[0012]FIGS. 4A-4F illustrate exemplary embodiments of connectors for use in
the system
illustrated in FIG. 1 in accordance with the present disclosure. The exemplary
connectors may be
positioned between one or more transducer arrays and one or more distal
circuits.
[0013] FIGS. 5A-5G illustrates exemplary embodiments of connectors for use in
the system
illustrated in FIG. 1 in accordance with the present disclosure. The exemplary
connectors may be
positioned between one or more distal circuits and one or more hubs.
DETAILED DESCRIPTION
[0014]The TTFields are generally delivered to patients via four transducer
arrays placed on the
patient's skin conventionally as two orthogonal pairs in locations chosen to
best target the
tumor. Each transducer array is configured as a set of coupled electrode
elements (for example,
about 2 cm in diameter) that are interconnected via flex wires. Commonly, each
electrode
element includes a ceramic disk that is sandwiched between a layer of an
electrically conductive
medical gel and an adhesive tape. When placing the arrays on the patient, the
medical gel
adheres to the contours of the patient's skin and ensures good electrical
contact of the device
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with the body. The adhesive tape holds the entire array in place on the
patient as the patient
goes about their daily activities.
[0015]The amplitude of the alternating current that is delivered via the
transducer arrays is
controlled so that skin temperature (as measured on the skin below the
transducer arrays) does
not exceed a safety threshold of 41 degrees Celsius. The temperature
measurements on the
patient's skin are obtained using thernnistors placed beneath some of the
disks of the transducer
arrays. In the existing Optune system, each array includes 8 thernnistors,
with one thernnistor
positioned beneath a respective disk in the array.
[0016]The thernnistors in each of the four arrays are connected via long wires
to an electronic
device called the "cable box" where the temperature from all 32 thernnistors
(i.e., four (4) arrays
x eight (8) thernnistors per array) is measured and analog-to-digital
converted into digital values
for each thernnistor. These measurements are then transmitted from the cable
box to the electric
field generator via an additional two wires that facilitate two-way digital
serial communications
between the cable box and the electric field generator. The controller in the
electric field
generator uses the temperature measurements to control the current to be
delivered via each
pair of arrays in order to maintain temperatures below 41 degrees Celsius on
the patient's skin.
The current itself is delivered to each array via an additional wire (i.e.,
one wire for each array)
that runs from the electric field generator through the cable box to the
array.
[0017] In the existing Optune system there are four long 10-wire cables (each
of which runs
between a respective array and the cable box) and one 8-wire spiral cord that
runs between the
electric field generator and the cable box. Each of the 10-wire cables has 8
wires for carrying
signals from the 8 thernnistors, 1 wire for the common ground of all 8
thernnistors, plus 1 wire
for providing the TTFields signal to the array. The 8-wire spiral cord has 1
wire for power to the
cable box (Vcc), 1 wire for ground to the cable box, 2 wires for data
communication (to send the
temperature readings to the field generator), plus 4 wires for TTFields signal
(i.e., one for each
of the four arrays).
[0018] Attaching temperature sensors and transducer arrays to a patient is
cumbersome with
the number of wires. As such, a connector may be used to provide a detachable
transducer array.
Such connector may also allow for reuse of wiring within the device.
Generally, the connector
may be formed of waterproof nnaterials.However, movement of a patient may
inadvertently
loosen and/or detach the connecter. As such, there is a need for detection
and/or indication of
status of conditions at the connector to provide a safe and/or effective
treatment for a patient.
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[0019]Therefore, a need exists for an apparatus for imposing electric fields
through a target
region in a body of a patient while minimizing cumbersome wiring associated
with the apparatus.
The apparatus comprises at least one transducer array having a plurality of
electrode elements
configured for placement on the body of the patient and at least one
temperature sensor. The
electrode elements are configured to provide TTFields. A distal circuit is
electrically coupled to
the at least one transducer array and operable to receive a temperature signal
from the at least
one temperature sensor. In some embodiments, a connector is electrically
connected to the
distal circuit and the distal circuit positioned in a circuit between the
transducer array and the
connector. Further, the apparatus may include at least one indicator
electrical connector
configured to provide feedback related to a status of the connector.
[0020] Before explaining at least one embodiment of the inventive concept(s)
in detail by way
of exemplary language and results, it is to be understood that the inventive
concept(s) is not
limited in its application to the details of construction and the arrangement
of the components
set forth in the following description. The inventive concept(s) is capable of
other embodiments
or of being practiced or carried out in various ways. As such, the language
used herein is intended
to be given the broadest possible scope and meaning; and the embodiments are
meant to be
exemplary - not exhaustive. Also, it is to be understood that the phraseology
and terminology
employed herein is for the purpose of description and should not be regarded
as limiting.
[0021] Unless otherwise defined herein, scientific and technical terms used in
connection with
the presently disclosed inventive concept(s) shall have the meanings that are
commonly
understood by those of ordinary skill in the art. Further, unless otherwise
required by context,
singular terms shall include pluralities and plural terms shall include the
singular.
[0022] All of the compositions, assemblies, systems, kits, and/or methods
disclosed herein can
be made and executed without undue experimentation in light of the present
disclosure. While
the compositions, assemblies, systems, kits, and methods of the inventive
concept(s) have been
described in terms of particular embodiments, it will be apparent to those of
skill in the art that
variations may be applied to the compositions and/or methods and in the steps
or in the
sequence of steps of the methods described herein without departing from the
concept, spirit,
and scope of the inventive concept(s). All such similar substitutions and
modifications apparent
to those skilled in the art are deemed to be within the spirit, scope, and
concept of the inventive
concept(s) as defined by the appended claims.
[0023] Unless otherwise expressly stated, it is in no way intended that any
method or aspect set
forth herein be construed as requiring that its steps be performed in a
specific order.
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Accordingly, where a method claim does not specifically state in the claims or
description that
the steps are to be limited to a specific order, it is no way intended that an
order be inferred, in
any respect.
[0024] Headings are provided for convenience only and are not to be construed
to limit the
invention in any manner. Embodiments illustrated under any heading or in any
portion of the
disclosure may be combined with embodiments illustrated under the same or any
other heading
or other portion of the disclosure. Any combination of the elements described
herein in all
possible variations thereof is encompassed by the invention unless otherwise
indicated herein
or otherwise clearly contradicted by context.
[0025]As utilized in accordance with the present disclosure, the following
terms, unless
otherwise indicated, shall be understood to have the following meanings:
[0026]The use of the term "a" or "an" when used in conjunction with the term
"comprising" in
the claims and/or the specification may mean "one," but it is also consistent
with the meaning
of "one or more," "at least one," and "one or more than one." As such, the
terms "a," "an," and
"the" include plural referents unless the context clearly indicates otherwise.
Thus, for example,
reference to "a compound" may refer to one or more compounds, two or more
compounds, or
greater numbers of compounds. The term "plurality" refers to "two or more."
[0027]The use of the term "at least one" will be understood to include one as
well as any
quantity more than one. The use of ordinal number terminology (i.e., "first,"
"second," "third,"
"fourth," etc.) is solely for the purpose of differentiating between two or
more items and is not
meant to imply any sequence or order or importance to one item over another or
any order of
addition, for example.
[0028]The use of the term "or" in the claims is used to mean an inclusive
"and/or" unless
explicitly indicated to refer to alternatives only or unless the alternatives
are mutually exclusive.
For example, a condition "A or B" is satisfied by any of the following: A is
true (or present) and B
is false (or not present), A is false (or not present) and B is true (or
present), and both A and B
are true (or present).
[0029]As used herein, any reference to "one embodiment," "an embodiment,"
"some
embodiments," "one example," "for example," or "an example" means that a
particular element,
feature, structure, or characteristic described in connection with the
embodiment is included in
at least one embodiment. The appearance of the phrase "in some embodiments" or
"one
example" in various places in the specification is not necessarily all
referring to the same
embodiment, for example.
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[0030]As used in this specification and claim(s), the words "comprising" (and
any form of
comprising, such as "comprise" and "comprises"), "having" (and any form of
having, such as
"have" and "has"), "including" (and any form of including, such as "includes"
and "include"), or
"containing" (and any form of containing, such as "contains" and "contain")
are inclusive or
open-ended and do not exclude additional, unrecited elements or method steps.
[0031 ]The term "patient" as used herein encompasses any mammals including
human and
veterinary subjects. "Mammal" for purposes of treatment refers to any animal
classified as a
mammal, including (but not limited to) humans, domestic and farm animals,
nonhuman
primates, and any other animal that has mammary tissue. In some embodiments,
the term
"patient" may apply to a simulation mannequin for use in teaching, for
example.
[0032]The treatments of the present disclosure may be used as part of a
combination therapy,
concurrent therapy, or adjunct therapy. As used herein, such terms are used
interchangeably
and will be understood to mean that the patient in need of treatment may be
treated or given
another drug for the condition/disease/infection in conjunction with the
treatments of the
present disclosure. This concurrent therapy can be sequential therapy, where
the patient is
treated first with one treatment protocol/pharmaceutical composition and then
the other
treatment protocol/pharmaceutical composition, or
the two treatment
protocols/pharmaceutical compositions are given simultaneously.
[0033]Circuitry, as used herein, may be analog and/or digital components, or
one or more
suitably programmed processors (e.g., microprocessors) and associated hardware
and software,
or hardwired logic. Also, "components" may perform one or more functions. The
term
"component," may include hardware, such as a processor (e.g., microprocessor),
an application
specific integrated circuit (ASIC), a field programmable gate array (FPGA), a
combination of
hardware and software, and/or the like. The term "processor" as used herein
means a single
processor or multiple processors working independently or together to
collectively perform a
task.
[0034]The term "TTField", as used herein, means tumor treating field.
[0035] Referring now to the drawings, and in particular FIGS. 1-3, shown
therein are block
diagrams of an exemplary embodiment of a system 10 having one or more distal
circuits 40
positioned in close proximity to one or more transducer arrays 50 to obtain
one or more
temperature readings from one or more temperature sensors 54 (see FIG. 3).
Each of the
transducer arrays 50 includes one or more electrode elements 52 (see FIG. 3).
The one or more
temperature sensors 54 are positioned to detect the temperature at the
electrode elements 52.
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In some embodiments, the temperature sensors 54 may be thernnistors,
thermocouples, RTDs,
integrated circuit temperature sensors such as the Analog Devices AD590 and
the Texas
Instruments LM135, and/or combinations thereof.
[0036] Alternative constructions for the transducer arrays may be used,
including, for example,
transducer arrays that use ceramic elements that are disc-shaped, transducer
arrays that use
ceramic elements that are not disc-shaped, and transducer arrays that use non-
ceramic dielectric
materials positioned over a plurality of flat conductors. Examples of the
latter include polymer
films disposed over pads on a printed circuit board or over flat pieces of
metal. Transducer arrays
that use electrode elements that are not capacitively coupled may also be
used. In this situation,
each element of the transducer array would be implemented using a region of a
conductive
material that is configured for placement against a person's body, with no
insulating dielectric
layer disposed between the conductive elements and the body. Examples of the
conductive
material include a conductive film, a conductive fabric, and a conductive
foam. Other alternative
constructions for implementing the transducer arrays may also be used, as long
as they are (a)
capable of delivering TTFields to the person's body and (b) utilize the
improved connector
designs described herein positioned in the locations specified herein.
Optionally, a layer of
hydrogel may be disposed between the transducer arrays and the person's body
in any of the
embodiments described herein.
[0037] In the event that a transducer array may be too large, or of an
unsuitable shape to
conveniently conform to the desired location of the body (for example, an
array to be positioned
on the side of the head where the ears partially block the desired location of
the array), the array
may be cut to a more convenient size and/or shape. Where the cutting is
desired to occur
through the printed circuit board of the array, exposed wires may be sealed
off to prevent direct
contact with the skin.
[0038] Each distal circuit 40 interfaces with the one or more temperature
sensors 54 that are
incorporated into the respective transducer array to obtain temperature
readings from each of
the one or more temperature sensor 54. The distal circuit 40 then may convert
(e.g., analog to
digital) the temperature readings, forward the temperature reading and/or send
the
temperature readings to a hub 30 (See FIG. 1). The hub 30 may then forward the
temperature
reading and/or send the temperature readings to an electric field generator 20
(e.g., via a serial
communication link). In some embodiments, the electric field generator 20 may
determine,
based on the temperature readings, adjustment of the current to the transducer
arrays 50.
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[0039] In some embodiments, short conductors (e.g., ten short conductors) may
extend distally
in the wiring 45 beyond the distal circuit 40 into the transducer array 50.
The short conductors
may include, for example, one conductor for each of one or more temperature
sensors 54, one
conductor for the one or more temperature sensors' common ground, and one
conductor for
the TTFields signal (i.e., the AC current for the electrode elements). In some
embodiments, the
distal circuit 40 may be implemented using a single-chip nnicrocontroller or
Programmable
System on Chip (PSoC) with a built in analog front end and multiplexer.
Suitable part numbers
for this purpose include the CY8C4124LQI-443, manufactured by the Cypress
Semiconductor
Corp. ( San Jose, California). As one skilled in the art will appreciate, some
embodiments may
include one or more nnicrocontrollers having built-in and/or discrete analog
front ends and/or
multiplexers. For example, the analog front end and multiplexer may obtain
temperature
readings from the one or more temperature sensors 54. Those temperature
readings may then
be digitized and/or transmitted to the hub 30, (e.g., via serial data link).
In some embodiments,
each distal circuit 40 may also include one or more pass-through conductors 51
(see FIG. 3). The
one or more pass-through conductors 51 may be configured to route one or more
TTFields signal
that originated in the electric field generator 20 to the transducer array 50.
[0040] Referring to FIGS. 1 and 3, each distal circuit 40 may be connected to
the hub 30 via one
or more cable 35. Conductors 51 in each cable 35 may run between the distal
circuit 40 and the
hub 30. For example, in FIG. 3, four conductors 51 run between each distal
circuit 40 and the
hub 30, including, one conductor 51 for power (Vcc), one conductor 51 for
grounding (GND), one
conductor for serial data communication (DATA), and one for the TTField
Signal.
[0041] FIG. 2 is a schematic diagram of a circuit for an exemplary hub 30 for
use in the system
illustrated in FIG. 1. Generally, the hub 30 may receive one or more
temperature readings
from each of the distal circuits 40 and sends the one or more temperature
readings to the electric
field generator 20. Any of a wide variety of architectures may be used to
receive and send the
one or more temperature readings. For example, in the illustrated embodiment,
a controller 32
sends a signal to a digital multiplexer 33 that commands the digital
multiplexer 33 to select one
of the distal circuits 40 such that the hub 30 may receive digital data from
the distal circuit 40
(i.e., the first distal circuit). The controller 32 receives the one or more
temperature readings
from the selected input of the first distal circuit 40 and transmits the one
or more temperature
readings to the electric field generator 20 via the transceiver 34. The
controller 32 may then
update the control signal to the digital multiplexer 33 such that the digital
multiplexer 33 selects
another distal circuit 40 (i.e., the second distal circuit 40). The controller
32 then receives one or
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more temperature readings from the input of the second distal circuit 40 and
transmits one or
more temperature readings to the electric field generator 20. Corresponding
sequences may
then be performed to obtain suitable temperature readings (e.g., eight
temperature readings)
from each of the distal circuits 40. In some embodiments, the entire sequence
of obtaining each
of the one or more temperature readings from each of the distal circuits 40 or
a portion of the
sequence may be repeated periodically (e.g., every 1 second, 10 seconds, or 30
seconds) to
update the one or more temperature readings that are provided to the electric
field generator
20.
[0042]In some embodiments, the controller 32, the digital multiplexer 33,
and/or the
transceiver 34 may be integrated together into a single chip. In some
embodiments, the
controller 32 and the digital multiplexer 33 may be integrated together into a
single chip, and a
separate transceiver 34 is used. For example, the controller 32 and the
digital multiplexer 33 may
be implemented using a Cypress CY8C4244LQI-443, described above, and the
transceiver 34 may
be implemented using a Linear Technology LTC2856CMS8-2#PBF, manufactured by
Linear
Technology Corp., having a principal place of business in Milpitas,
California.
[0043]The hub 30 may communicate with the electric field generator 20 using
any conventional
communication technique (e.g., RS485). In some embodiments, the hub 30 may
include one or
more pass-through conductors 31 configured to pass one or more TTField signals
directly from
the electric field generator 20 to each of the transducer arrays 50. In some
embodiments, the
hub 30 may communicate with the electric field generator 20 via an 8-conductor
spiral cable 25.
For example, the hub 30 may communicate with the electric field generator 20
via an 8-
conductor spiral cable 25 wherein four wires may provide for TTFields signals
to be received by
each transducer array 50, one wire may provide for ground (GND), one wire may
provide for
voltage (Vcc) to the distal circuits 40, and two wires may provide for
communication (RS485A
and RS4858). It should be noted that use of the 8-conductor spiral cable 25 is
configured to be
backwards compatible with prior versions of TTField delivery systems within
the art as one skilled
in the art will appreciate.
[0044]Communication wires may be configured to implement data communications
between
the hub 30 and the electric field generator 20 (see FIG. 1) (i.e., for the
temperature data). In
some embodiments, one wire may be configured to implement communication in
each
direction. In some embodiments, wire count between the hub 30 and the electric
field generator
20 can be reduced by replacing multiple data communication wires with a single
data wire that
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implements two-way communication (using a conventional single wire
communication
protocol).
[0045] FIG. 3 is a schematic diagram of an exemplary circuit for interfacing
the hub 30 with the
one or more transducer array 50. Each transducer array 50 may include one or
more electrode
elements 52 and one or more temperature sensors 54 positioned to sense
temperatures of the
one or more electrode elements 52. In some embodiments, one or more
temperature sensors
54 may be thernnistors. For example, the one or more temperature sensors 54
may include, but
are not limited to, thernnistors, thermocouples, RTDs, integrated circuit
temperature sensors
such as the Analog Devices AD590 and the Texas Instruments LM135, and/or
combinations
thereof. It is contemplated that any temperature sensor 54 known within the
art may be used if
configured to provide an accurate and/or precise temperature reading in
accordance with the
present disclosure.
[0046] A multiplexer 81 may include an output 92 and one or more selectable
inputs 94. Each of
one or more selectable inputs 94 may be connected to a respective one of the
temperature
sensors 54. At least one terminal of each temperature sensor 54 may be a
common ground. In
some embodiments, the output 92 of the multiplexer 81 may be provided to an
input 96 of an
amplifier 82, (e.g., amplifier having a high input impedance such as an op amp
configured as a
voltage follower). Output 98 of the amplifier 82 may be provided to an input
100 of an analog to
digital converter 83. Output 102 of the analog to digital converter is
provided to input 104 of a
controller 85.
[0047] In some embodiments, the controller 85 may be configured to orchestrate
operation of
one or more of the components within the dashed line 80. The controller 85 may
be configured
to send one or more commands to the multiplexer 81 to select one of the
temperature sensors
54, in order to obtain a temperature reading from that temperature sensor 54.
[0048] In some embodiments, temperature readings may be obtained by routing a
known
current through the temperature sensor 54 (e.g., thernnistor) and measuring
the voltage that
appears across the temperature sensor 54. For example, a programmable current
source 88 may
be configured to generate a known current (e.g., 150 A). The multiplexer 81
may be
bidirectional such that the known current may be routed to the temperature
sensor 54 selected
by the multiplexer 81.
[0049] In some embodiments, temperature readings from the one or more
temperature sensors
54 may be obtained using the following method. The controller 85 sends one or
more commands
to the multiplexer 81 to select the first temperature sensor 54, and
configures the current source
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88 to generate a known current. The known current from the current source 88
is configured to
flow through the multiplexer 81 into the first temperature sensor 54 resulting
in a voltage
appearing across that temperature sensor 54 and at the output 92 of the
multiplexer 81. The
amplifier 82 provides this voltage to the input 100 of the analog to digital
converter 83. The
controller 85 instructs the analog to digital converter 83 to digitize this
voltage. The controller
85 obtains this reading from the analog to digital converter 83 and
temporarily stores the
digitized reading (which corresponds to the first temperature sensor 54) in a
buffer. This
procedure may be repeated, sequentially, for each of the temperature sensors
54 until digitized
readings from each requested temperature sensor 54 is within the buffer.
[0050] In some embodiments, a conventional voltage divider approach for
interfacing with the
one or more temperature sensors 54 may be used. In some embodiments,
additional readings
may be obtained and used for self-calibration to increase the accuracy and/or
precision of the
temperature readings obtained from the one or more temperature sensors 54. For
example, in
FIG. 3, at least one input 94GND of the multiplexer 81 is connected to ground,
and at least one
input 94R of the multiplexer 81 is connected to a precision resistor 89. In
some embodiments,
the precision resistor 89 is a 10 kOhnn, 0.1% tolerance resistor. Readings
from the precision
resistor 89 may be obtained using the same procedure described above for
obtaining a reading
from the one or more temperature sensors 54. Obtaining readings from the
grounded input
94GND of the multiplexer 81 may also be similar, except that the current
source 88 may be
deactivated when the grounded input 94GND is selected. The controller 85 may
temporarily store
the digitized readings from the precision resistor 89 and the grounded input
94GND in a buffer
(e.g., total of 10 readings are stored in the buffer) and/or any memory
configured to store data.
These additional readings may ultimately be used to calibrate the readings
that were obtained
from the one or more temperature sensors 54. In some embodiments, such
calibration may be
implemented via the controller 85. In some embodiments, calibration may occur
prior to
transmission of the digital data that corresponds to the temperature readings.
In some
embodiments, calibration may be implemented in a downstream processor (e.g.,
the controller
32 in the hub 30) such that the digital data corresponding to the precision
resistor 89 (and
optionally the grounded input 94GND) may be transmitted to a downstream
processor, in addition
to, any uncalibrated temperature readings obtained from the one or more
temperature sensor
54.
[0051 ] In some embodiments, the controller 85 in the distal circuit 40 may be
configured to
communicate with the hub 30 via UART 86, and transmit the temperature readings
obtained
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from the one or more temperature sensors 54 to the hub 30. In some
embodiments, the
controller 85 may be programmed to operate autonomously and configured to
automatically
collect temperature readings from each of the one or more temperature sensors
54, storing the
result in a buffer as described above, and subsequently transmitting contents
of the buffer (i.e.,
readings for each of the temperature sensors 54, and optionally the additional
readings
described herein) to the hub 30.
[0052] In some embodiments, temperature measurements may be synchronized. For
example,
the master controller in the hub 30 may send a "collect samples" command to
one or more
controllers 85 either simultaneously or in rapid succession, such that the
temperature readings
obtained from each of the transducer arrays 50 may be obtained at or near the
same time. In
some embodiments, the temperature readings may be collected by the hub 30 in
one or more
batches of each controller 85.
[0053] Most systems that use TTFields to treat tumors switch the direction of
the field that is
being applied to the tumor periodically (e.g., every second). To minimize
noise in the
temperature measurements, a small time gap during which the field is not
applied in either
direction may be introduced, and the temperature measurements can be made
during the time
gap.
[0054] In some embodiments, some or all of the following components may be
implemented by
a single integrated circuit: multiplexer 81, amplifier 82, analog to digital
converter 83, controller
85, UART 86, and current source 88. One example of a single integrated circuit
that includes all
of these functional blocks is the Cypress CY8C41241Q1-443T programmable system
on chip
(PSoC), manufactured by Cypress Semiconductor Corp.
[0055] In some embodiments, wires that provide power and ground to the distal
circuit 40 can
be eliminated by diverting some of the energy from the TTFields signal (which
is delivered via
pass-through conductors) using a coil, storing that energy in a capacitor
adjacent to the distal
circuit 40, and powering the distal circuit 40 using the stored energy. In
some embodiments, a
one-wire communication protocol may transmit the temperature data over the
TTFields signal
wire. In such a configuration, the data communication signals and power (Vcc)
for the distal
circuit 40 may be removed from the cable that runs to the transducer array 50.
If all of these
wire reduction techniques are implemented, only two wires may be needed
between the hub
30 and each transducer array 50 (i.e., 1 for the TTField signal and 1 for
ground). As such, the total
number of wires from the four transducer arrays 50 to the electric field
generator 20 may be
reduced (e.g., to 5 total wires with 1 for a common ground and a total of 4
for the TTField signals).
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[0056]The process of monitoring the temperature at the electrodes allows for
operation of the
TTFields treatment while staying below the temperature safety threshold, but
introduces
cumbersome apparatus and wiring. The use of a connector adds the convenience
of detaching
the transducer arrays. However, the electric field generator should be powered
down prior to
disconnecting the connector, and accidental disconnection of the connector is
to be avoided.
[0057] Referring to FIGS. 4A-4F, one or more connectors 42 may be included
between the hub
30 and one or more of the transducer arrays 50. Connectors 42 may be
configured such that a
patient and/or caregiver may be able to attach the transducer arrays 50 to the
patient's skin
without being hindered by the presence of cables. In some embodiments, one or
more
connectors 42 may be waterproof to prevent moisture (e.g., perspiration,
showers, etc.) from
interfering with the electric circuitry.
[0058] In some embodiments, the one or more connectors 42 may be positioned
between the
transducer array 50 and the hub 30. In some embodiments, the connector 42 may
be positioned
between the transducer array 50 and the distal circuit 40 as shown by
connector 42a in FIGS. 4A-
4F.
[0059] Generally, the one or more connectors 42 may be electrically
connected to the at
least one transducer array 50. The one or more connectors 42 may include a
plurality of electrical
connectors 200 in electrical communication with the one or more transducer
array 50.
Additionally, the one or more connectors 42 may include at least one indicator
electrical
connector 202 electrically isolated from the one or more transducer array 50
in order to provide
a warning that the connector is disconnecting and the electric field generator
should be powered
down. The at least one indicator electrical connector 202 may be configured to
provide feedback
related to status of the connector 42. In some embodiments, the at least one
indicator electrical
connector 202 includes two indicator electrical connectors with the connector
42 having a
conductive line 214 electrically connecting the two indicator electrical
connectors 202. The at
least one indicator electrical connector 202 may have a gender, such as male
or female. By way
of example, the indicator electrical connector 202 will be described
hereinafter as an indicator
pin 202, although other constructs may be used, such as, for example, a pinch
clip which may
optionally be deliberately triggered by the patient to release the connector
(and simultaneously
send a command to the electric field generator to power down). In some
embodiments, the
indicator pins 202 have a first length less than a second length of at least
one of the plurality of
electrical connectors 200. For clarity and conciseness, the description set
forth herein refers to
the electrical connectors 200 and indicator electrical connectors 202 as
"pins" or "sockets";
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however, one skilled in the art will appreciate that the electrical connectors
200 and indicator
electrical connectors 202 do not necessarily have "pins" or "sockets", and may
be any device
configured to have electrical communication with the one or more transducer
arrays 50 as set
forth in the description. For example, a USB-type connector may be adapted by
presenting one
or more conductive trace within the connector that is shorter compared to
others therein, and
may be adapted to provide indication of an incomplete connection. Preferably,
the mechanism
allows for quick release if desired (deliberate), and also for detection of
(accidental) release or
disconnect, preferably prior to full disconnect. In some embodiments, the
connector includes a
quick release mechanism that is activated by a sensor that detects the patient
depressing a
button on the apparatus to disconnect the connector.
[0060] Referring to FIGS. 4A-4C, in some embodiments, the one or more
transducer arrays 50
may be sterilized before use (e.g., via radiation and/or gas). As the distal
circuit 40 is located
between the connector 42a and the hub 30, the portion of the system 10 that
includes the distal
circuit 40 may not require sterilization. This permits sterilization of the
transducer arrays 50 (e.g.,
using gas and/or radiation) without risk of damage to the distal circuit 40.
[0061] In some embodiments, a plurality of signals 110 may traverse the
connector 42. For
example, in FIG. 4B, ten signals 110 may traverse the connector 42 with one
signal 110a for the
AC current to the one or more electrode elements 52; one signal 110b for each
of the
temperature sensors 54 (e.g., subtotal of eight); and, one signal 110c for a
common ground that
may be used for all of the temperature sensors 54.
[0062]In some embodiments, a substrate 59 may support one or more of the
electrode
elements 52 (see FIG. 4C). The one or more electrode elements 52 may be
positioned on and/or
against a body of a patient (e.g., head). The substrate 59 may be configured
to hold and/or affix
the one or more electrode elements 52 against the body of the patient. The one
or more
temperature sensors 54 may be positioned adjacent to and/or beneath respective
electrode
elements 52 such that the one or more temperature sensors 54 are configured to
sense
temperature of the electrode elements 52.
[0063]A cable 35 has a first end 120 and a second end 122. The cable 35 may
include (i) a
conductor 51 that permits current (e.g., AC current) to flow between the first
end 120 of the
cable 35 and the second end 122 of the cable 35; and, (ii) a data path 124
configured to carry
digital data corresponding to temperature readings originating in the distal
circuit 40 from the
second end 122 of the cable 35 to the first end 120 of the cable 35 (i.e., in
the direction of the
hub 30).
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[0064] In some embodiments, a module 60 may be mounted (e.g., either directly
or through
intervening components) to the second end 122 of the cable 35. The distal
circuit 40 may be
mounted in the module 60. In some embodiments, power (voltage, VCC) and ground
(GND) for
the distal circuit 40 may be provided via the cable 35.
[0065]A first portion 140 of the connector 42a may be provided at or on the
module 60, and a
second portion 142 of the connector 42a may be provided at or on the substrate
59. The first
portion 140 of the connector 42a mates with the second portion 142 of the
connector 42a such
that electrical signals are configured to pass through the connector 42a from
the transducer
array 50 to the distal circuit 40 and then the hub 30. To that end, when the
first portion 140 of
the connector 42a is mated to the second portion 142 of the connector 42a,
signals from the one
or more temperature sensors 54 are configured to travel through wiring on the
substrate 59,
through the connector 42a, and into the distal circuit 40. The distal circuit
40 includes the
multiplexer 81, the analog to digital converter 83, and the controller 85. In
addition, the common
ground signal 110c for the one or more temperature sensors 54 may be provided
through the
connector 42a, in addition to, AC current signal 110a for the electrode
elements 52. The AC
current signal 110a may continue through appropriate wiring on the substrate
59 such that the
one or more electrode elements 52 may be electrically connected to a
corresponding conductor
of the cable 35.
[0066] Referring to FIG. 4C and 4D, in some embodiments, the signals 110a-110c
may pass
through the connector 42a via conductive elements within the connector 42a.
The conductive
elements may include the plurality of pins 200 such that the first portion 140
of the connector
42a is nnatingly connected to the second portion 142. In some embodiments, one
or more pins
200 may be provided on the first portion 140 of the connector 42a to nnatingly
connect to
conductive elements on the second portion 142 of the connector 42a. In some
embodiments,
one or more pins 200 may be provided on the second portion 142 of the
connector 42a to
nnatingly connect to conductive elements on the first portion 140 of the
connector 42a.
[0067] In some embodiments, the connector 42a may include one or more
indicator pin(s) 202
in addition to pins 200. The one or more indicator pin(s) 202 may be
integrated into the
connector 42a at the first portion 140 and/or the second portion 142 of the
connector 42a. In
some embodiments, one or more indicator pin(s) 202 may be integrated on the
same one of the
first portion 140 or second portion 142 of the connector 42a as the pins 200.
In some
embodiments, one or more indicator pin(s) 202 may be integrated on a different
one of the first
portion 140 or the second portion 142 of the connector 42a as compared to the
pins 200. For
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example, the pins 200 can be non-removably mounted to the first portion 140,
and the indicator
pin(s) 202 can be non-removably mounted to the second portion 142. FIG. 4F
illustrates another
exemplary embodiment of the connector 42a wherein the electrical connectors
200 (e.g., pins)
and indicator electrical connectors 202 (e.g., indicator pins) may be non-
removably mounted to
the second portion 142, shown as a connector 42g.
[0068]The connector 42a may include a first end 204 and a second end 206 (FIG.
4D and 4E). In
some embodiments, one or more indicator pin(s) 202 may be positioned at the
first end 204
and/or the second end 206 of the connector 42a. In some embodiments, at least
one indicator
pin 202 may be positioned at the first end 204 of the connector 42a and at
least one indicator
pin 202 may be positioned at the second end 206 of the connector 42a. In some
embodiments,
one indicator pin 202 may be positioned at the first end 204 of the connector
42a, or the one
indicator pin 202 may be positioned at the second end 206 of the connector
42a. For clarity and
conciseness, exemplary embodiments illustrate a single indicator pin 202 (see
FIG. 4D) or two
indicator pins 202a and 202b (see FIG. 4E), however, any number of indicator
pins 202 may be
used and are contemplated within the present disclosure.
[0069] Because signals 110b provided from the temperature sensors 54 may be
influenced by
changes associated with salt water (e.g., sweat from a patient within the
connector 42a may
result in higher temperature reading data from the measured data), in some
embodiments, the
first portion 140 and the second portion 142 of the connector 42a may
generally be formed of
waterproof material (e.g., rubber) to prevent moisture (e.g., perspiration,
showers, etc.) from
interfering with the electric circuitry including the pins 200 and the
indicator pin(s) 202. Further,
the first portion 140 and the second portion 142 may be configured to mate
together to form a
waterproof seal that protects the pins 200 and the indicator pin(s) 202 from
intrusion from water
external to the first portion 140 and the second portion 142. Additionally,
the intrusion of non-
salt water and/or salt water may indicate disconnection (or lack of full
waterproof connection)
between the first portion 140 and the second portion 142 of the connector 42a.
The one or more
indicator pin(s) 202 may provide feedback regarding status of the connector
42a. Status may be
one or more conditions of the connector 42a during use of the system 10.
Conditions may
include, but are not limited to, lack of connection, presence of water,
presence of salt, presence
of one or more external substances, disconnection of the first portion 140
from the second
portion 142, combinations thereof and the like. To that end, in some
embodiments, the indicator
pin(s) 202 may aid in detection of disconnection of the first portion 140 of
the connector 42a to
the second portion 142 of the connector 42a, for example. In some embodiments,
the indicator
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pin(s) 202 may aid in detection of voltage loss, loss of current, and/or the
like between the first
portion 140 of the connector 42a and the second portion 142 of the connector
42a, for example.
[0070] Referring to FIG. 4D, one or more pins 200 on the first portion 140 of
the connector 42a
may nnatingly connect to one or more socket connectors 212a on the second
portion 142 of the
connector 42a. Similarly, one or more indicator pin(s) 202 on the first
portion 140 of the
connector 42a may nnatingly connect to one or more indicator socket connectors
212b on the
second portion 142 of the connector 42a. The pins 200, the indicator pin(s)
202, the socket
connectors 212a, and the indicator socket connector(s) 212b are constructed of
or coated with
a conductive material, such as copper, aluminum, gold, silver, and
combinations thereof. In some
embodiments, depth dp of the socket connector 212a associated with the
respective pin 200 may
be similar to depth d1 of the indicator socket connector 212b associated with
the respective
indicator pin 202. In some embodiments, depth dp of the socket connector 212a
associated with
the respective pin 200 may be configured to be greater than depth d1 of the
indicator socket
connector 212b associated with the respective indicator pin 202 such that
disconnection
between the one or more indicator pin(s) 202 and the indicator socket
connector(s) 212b may
occur prior to disconnection of the pins 200 from the socket connectors 212a.
Monitoring
connection or disconnection of the one or more indicator pin(s) 202 and the
indicator socket
connector(s) 212b permits detection of partial disconnection and therefore
possible and/or
probable disconnection (or imminent disconnection) of the first portion 140
from the second
portion 142.
[0071] In some embodiments, the one or more indicator pin(s) 202 may have a
length Li similar
to length Lp of the pins 200. In some embodiments, the length Li of the one or
more indicator
pin(s) 202 may be shorter than the length Lp of the pins 200 such that
disconnection between
the one or more indicator pin(s) 202 and the associated indicator socket
connector 212b may
occur prior to disconnection of the pins 200 and associated socket connector
212a and/or one
or more indicator pin(s) 202 may be configured to provide detection of
possible and/or probable
disconnection of the first portion 140 from the second portion 142.
[0072] Referring to FIG. 4D, in some embodiments, the one or more indicator
socket connectors
212b may be in electrical communication with one or more resistors RI. Current
can be supplied
to the one or more indicator socket connector(s) 212b from the indicator pin
202. Current may
be provided by controller 85, distal circuit 40, hub 30, electric field
generator 20, an external
source, or combinations thereof. In some embodiments, the resistor RI may be
the precision
resistor 89 described herein. In some embodiments, the resistor RI may be one
or more separate
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resistors. An electrical parameter, such as voltage across the one or more
resistors RI, may be
monitored by an instrument 213 to determine status of the connector 42a. The
voltage across
the one or more resistor(s) RI may be monitored and/or logged at a plurality
of instances of time
with the instrument 213 to detect changes in the electrical parameter, such as
voltage across
the resistor RI. For example, once the indicator pin 202 is nnatingly engaged
and/or nnatingly
connected with the indicator socket connector 212b, changes in voltage across
the resistor RI
may indicate salt water entering between the first portion 140 and the second
portion 142 of
the connector 42a. In some embodiments, a calibrated voltage across the
resistor RI may be
determined. Variations from the calibrated voltage may indicate a different
status of the
connector 42a (e.g., salt water present, disconnected first portion 140 and
second portion 142).
Complete voltage loss to the resistor RI may indicate disconnection of the
first portion 140 from
the second portion 142.
[0073] Referring now to FIG. 4E, shown therein is a diagram of an exemplary
embodiment of a
connector 42b constructed in accordance with the construction of the connector
42a with the
exception that, in some embodiments, two or more indicator pins 202 (shown in
FIG. 4E as
indicator pin 202a and indicator pin 202b) may form one or more monitoring
circuits 210 (e.g.,
simple circuit, series circuit) across a first portion 140b of a connector 42b
and a second portion
142b of the connector 42b. In some embodiments, the indicator pins 202 may be
positioned on
the first portion 140b of the connector 42b and corresponding indicator socket
connectors 212b
may be positioned on the second portion 142b of the connector 42b. One or more
conductive
lines 214 may be provided between indicator socket connectors 212b. Current
may be provided
by controller 85, distal circuit 40, hub 30, electric field generator 20, an
external source, or
combinations thereof. To that end, when the indicator pins 202a, 202b are
nnatingly engaged
within the indicator socket connectors 212b, a monitoring circuit 210 (e.g.,
closed circuit) may
be formed.
[0074]Although the monitoring circuit 210 is described herein as being a
closed circuit, it should
be understood that the monitoring circuit 210 can be implemented in other
manners to
determine the status of the connector 42b. Exemplary status includes relative
locations of the
first portion 140b and the second portion 142b to determine whether the first
portion 140b and
the second portion 142b are connected or disconnected. The monitoring circuit
210 may monitor
one or more electrical sensors, optical sensors, or mechanical mechanisms to
determine the
relative locations and/or orientation of the first portion 140b and the second
portion 142b.
Exemplary electrical sensors include inductive proximity sensors, magnetic
proximity sensors, or
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capacitive proximity sensors. In each of these electrical sensors, a sensor
can be mounted on one
of the first portion 140b and the second portion 142b, and a detection object
may be mounted
on the other one of the first portion 140b and the second portion 142b.
Optical sensors may
include a photosource (e.g., photodiode) mounted to one of the first portion
140b and the
second portion 142b, and an optical detector (e.g., photodiode) mounted to the
other one of
the first portion 140b and the second portion 142b. In other embodiments, the
photosource and
the optical detector can be mounted to either one of the first portion 140b or
the second portion
142b, and a reflector can be mounted to the other one of the first portion
140b and the second
portion 142b. Examples of mechanical mechanisms, such as the one or more
indicator pin(s) 202
and indicator socket connectors 212b monitored by the monitoring circuit 210
are described in
detail herein. If one or more indicator pin(s) 202a, 202b become disconnected
from the indicator
socket connectors 212b, the monitoring circuit 210 is broken and current does
not flow through
the second portion 142 of the connector 42b. Monitoring for changes in current
along the
monitoring circuit 210 (e.g., by the controller 85) may provide status of the
connector 42b.
[0075] In some embodiments, the monitoring circuit 210 may include one or more
resistors RI.
Similar to the exemplary embodiment in FIG. 4D, voltage across the one or more
resistors RI may
be monitored to determine status of the connector 42b. For example, changes in
voltage across
the resistor RI may indicate salt water entering between the first portion 140
and the second
portion 142 of the connector 42b. In some embodiments, a calibrated voltage
across the resistor
RI may be determined. Variations from the calibrated voltage may indicate a
different status of
the connector 42b (e.g., salt water present, disconnected first portion 140
and second portion
142). Complete voltage loss to the resistor RI may indicate disconnection of
the first portion 140
from the second portion 142.
[0076] Referring to FIGS. 1, 4D, and 4E, in some embodiments, an indicator
system 260 is
provided with circuitry that may be configured to provide data, status,
conditions, actions,
commands or combinations thereof to a user and/or patient. For example, in
some
embodiments, the indicator system 260 may provide data associated with the
status of one or
more components of the system 10 (e.g., on/standby, error indications, status
of battery charge,
compliance metrics). In some embodiments, the indicator system 260 may be
mounted at any
point along the cable 25 between the hub 30 and the electric field generator
20. In some
embodiments, the indicator system 260 may be mounted to the hub 30. In some
embodiments,
the indicator system 260 may be mounted at the distal circuit 40. In some
embodiments, the
indicator system 260 may be mounted at the controller 85. In some embodiments,
the indicator
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system 260 may be integrated within the connector 42, within the hub 30,
within the electric
field generator 20, within the controller 85 and/or combinations thereof.
[0077] In some embodiments, the indicator system 260 may perform or cause the
performance
of a predetermined action such as providing visual, auditory and/or haptic
feedback to the user
regarding status of the connector 42 based upon receipt of one or more signals
generated by the
monitoring circuit 210. The indicator system 260 may receive data regarding
variation in voltage
and/or variation in current provided via use of the indicator pin(s) 202. Data
regarding variation
in voltage and/or variation in current provided via use of the indicator
pin(s) 202 may provide
one or more feedback commands to a user. One or more feedback commands may be
provided
via visual system (e.g., LED light, screen, monitor, and/or the like),
auditory (e.g., tone, buzz) or
haptic system (e.g., vibration). Feedback commands, also referred to as an
associative action,
may include, but are not limited to, "Take connector apart", "Dry connector",
"Apply force to
connector", and/or the like. For example, the visual system may provide a red
light indicating
the status of the connector 42 is poor and commanding the user to "Take apart
connector" or
"Push connector together." In another example, the visual system may provide a
green light
indicating the status of the connector 42 is good and commanding the user to
"Continue using
the system". As described herein, the system may be configured to signal the
electric field
generator to power down. For example, detection of disconnection of indicator
pins from
indicator socket connectors could be used as a safety mechanism to power down
the electric
field generator.
[0078] FIG. 5A-5E, illustrate exemplary embodiments of the connector 42
positioned between
the distal circuit 40 and the hub 30 such that signals 250 from the distal
circuit 40 traverse the
connector 42. For example, in FIG. 58 and FIG 5C, four signals 250a-d traverse
the connector 42c:
a first signal 250a for the AC current that goes to the electrode elements 52
("AC Current"), a
second signal 250b for data that travels between the UART 86 and the hub 30
("Data"); a third
signal 250c for power to the distal circuit 40 ("VCC"), and a fourth signal
250d for ground for the
distal circuit 40 ("GND").
[0079] Referring to FIGS. 58 and 5C, the substrate 59 may support the one or
more electrode
elements 52. The one or more electrode elements 52 may be configured for
placement against
the body of the patient (e.g., head), and/or the substrate 59 may be
configured to hold the
plurality of electrode elements 52 against the body of the patient. The one or
more temperature
sensors 54 may be positioned adjacent to and/or beneath respective electrode
elements 52 such
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that the one or more temperature sensors 54 can sense the temperature of the
electrode
elements 52.
[0080] A module 65 may be mounted (either directly or through intervening
components) to the
substrate 59. In some embodiments, the distal circuit 40 may be mounted in the
module 65. In
some embodiments, power (voltage, VCC) and ground (GND) for the distal circuit
40 may be
provided via cable 35. The first portion 140c of the connector 42c is provided
at the second end
122 of the cable 35, and the second portion 142c of the connector 42c is
provided on the
substrate 59. The first portion 140c of the connector 42c is nnatingly
connected to the second
portion 142c of the connector 42c such that electrical signals can pass
through both portions
140c and 142c of the connector 42c. When both portions 140c and 142c of the
connector 42c
are mated, signals from the cable 35 may travel through the connector 42c, and
into the distal
circuit 40. Similarly, when both portions 140c and 142c of the connector 42c
are mated, signals
from the distal circuit 40 may travel through the connector 42c to the hub 30.
[0081] In some embodiments, the cables 35 may be disconnected from the
substrate 59 when
the one or more transducer arrays 50 are initially placed on the body of the
patient. Once the
one or more transducer arrays 50 are in a desired position, the cables 35 may
be connected to
the transducer arrays 50 via the connector 42c.
[0082] Referring to FIG. 5C and FIG. 5D, in some embodiments, similar to FIGS.
4C and 4D, the
signals 250a-250d (shown in FIG. 58) may be provided via a plurality of pins
200 such that the
first portion 140c of the connector 42c is nnatingly connected and/or
nnatingly engaged to the
second portion 142c. In some embodiments, one or more pins 200 may be provided
on the first
portion 140c of the connector 42c to nnatingly connect to the second portion
142c of the
connector 42c (shown in FIG. 5D). In some embodiments, one or more pins 200
may be provided
on the second portion 142c of the connector 42c to nnatingly connect to the
first portion 140c of
the connector 42c.
[0083] In some embodiments, the connector 42c may include one or more
indicator pin(s) 202
in addition to pins 200. The one or more indicator pin(s) 202 may be
integrated into the
connector 42c. In some embodiments, one or more indicator pin(s) 202 may be
integrated on
the same portion 140c or 142c of the connector 42c as the pins 200. In some
embodiments, one
or more indicator pin(s) 202 may be integrated on a different one of the first
portion 140c or
second portion 142c of the connector 42c as the pins 200. The connector 42c
may include a first
end 204c and a second end 206c. In some embodiments, one or more indicator
pin(s) 202 may
be positioned at the first end 204c and/or the second end 206c of the
connector 42c. In some
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embodiments, at least one indicator pin 202 may be positioned at the first end
204c of the
connector 42c and at least one indicator pin 202 may be positioned at the
second end 206c of
the connector 42c. In some embodiments, one indicator pin 202 may be
positioned at the first
end 204c of the connector 42c or positioned at the second end 206c of the
connectors 42c. For
clarity and conciseness, exemplary embodiments illustrating single indicator
pin 202 (shown in
FIG. 5D) and two indicator pins 202 (shown in FIG. 5E) are illustrated,
however, any number of
indicator pins 202 may be used and are contemplated within the present
disclosure.
[0084]The one or more indicator pin(s) 202 may provide feedback regarding
status of the
connector 42c. To that end, in some embodiments, the indicator pin(s) 202 may
aid in detection
of disconnection or partial disconnection of the first portion 140c of the
connector 42c to the
second portion 142c of the connector 42c. In some embodiments, the indicator
pin(s) 202 may
aid in detection of voltage loss, loss of current, and/or the like between the
first portion 140c of
the connector 42c and the second portion 142c of the connector 42c.
[0085] Referring to FIG. 5D, one or more pins 200 on the first portion 140c of
the connector 42c
may nnatingly connect to one or more socket connectors 212a. Similarly, one or
more indicator
pin(s) 202 on the first portion 140c of the connector 42c may nnatingly
connect to one or more
indicator socket connectors 212b on the second portion 142c of the connector
42c. In some
embodiments, depth dp of the socket connector 212a associated with the
respective pin 200 may
be similar to depth d1 of the indicator socket connector 212b associated with
the respective
indicator pin 202. In some embodiments, depth dp of the socket connector 212a
associated with
the respective pin 200 may be configured to be greater than depth d1 of the
indicator socket
connector 212b associated with the respective indicator pin 202 such that
disconnection
between the one or more indicator pin(s) 202 may occur prior to disconnection
of the pins 200
and/or one or more indicator pin(s) 202 may be configured to provide detection
of partial
disconnection and therefore possible and/or probable disconnection of the
first portion 140c
from the second portion 142c.
[0086] In some embodiments, the length Li of the one or more indicator pin(s)
202 may be similar
to length Lp of the pins 200. In some embodiments, the length Li of the one or
more indicator
pin(s) 202 may be shorter than the length Lp of the pins 200 such that
disconnection between
the one or more indicator pin(s) 202 from the associated indicator socket
connector 212b may
occur prior to disconnection of the pins 200 from the associated socket
connector 212a and/or
one or more indicator pin(s) 202 may be configured to provide detection of
partial disconnection
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or possible and/or probable disconnection of the first portion 140c from the
second portion
142c.
[0087] Referring to FIG. 5D, in some embodiments, the one or more indicator
socket connectors
212b may be in electrical communication with one or more resistors RI. In some
embodiments,
the resistor RI may be the precision resistor 89 described herein. In some
embodiments, the
resistor RI may be one or more separate resistors. Voltage across the one or
more resistors RI
may be monitored to determine status of the connector 42c. For example, once
the indicator pin
202 is nnatingly connected and/or engaged with the indicator socket connector
212b, changes in
voltage across the resistor RI may indicate salt water entering between the
first portion 140c and
the second portion 142c of the connector 42c. In some embodiments, a
calibrated voltage across
the resistor RI may be determined. Variations from the calibrated voltage may
indicate a
different status of the connector 42c (e.g., salt water present, disconnected
first portion 140c
and second portion 142c, partial disconnection). Complete voltage loss to the
resistor RI may
indicate disconnection of the first portion 140c from the second portion 142c.
[0088] Referring now to FIG. 5E, shown therein is a connector 42d constructed
in accordance
with the connector 42c, described above, with the exception that, in some
embodiments, two
or more indicator pins 202 may form one or more monitoring circuit 210a (e.g.,
simple circuit,
series circuit) across a first portion 140d of the connector 42d and a second
portion 142d of the
connector 42d. In some embodiments, the indicator pins 202 may be positioned
on the first
portion 140d of the connector 42d and corresponding indicator socket
connectors 212b may be
positioned on the second portion 142d of the connector 42d. One or more
conductive lines 214
may be provided between the indicator pins 202, or the indicator socket
connectors 212b. In the
embodiment shown in FIG. 5E, current may be provided by controller 85, distal
circuit 40, hub
30, electric field generator 20, an external source, or combinations thereof.
To that end, when
the indicator pins 202 are nnatingly engaged within the indicator socket
connectors 212b, a
monitoring circuit 210a (i.e., closed circuit) may be formed. If one or more
indicator pins 202
become disconnected from the indicator socket connectors 212b, the monitoring
circuit 210a is
broken and current does not flow through the second portion 142d of the
connector 42d.
Monitoring for changes in current along the monitoring circuit 210a may
provide status of the
connector 42d by disconnecting the one or more indicator pin(s) 202 from the
associated
indicator socket connector 212b prior to disconnection of the pins 200 from
the associated
socket connectors 212a (e.g., a partial disconnection).
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[0089] Referring to FIG. 5F, shown therein is another example of a connector
42e constructed in
accordance with the present disclosure. The connector 42e includes a first
portion 140e and a
second portion 142e. The connector 42e is similar in construction and function
as the connector
42d described above with the exception that the indicator pins 202 are a same
length as the pins
200, but the indicator socket connectors 212b are recessed within the second
portion 142e. In
particular, the second portion 142e is provided with a first side 216 adjacent
to the socket
connectors 212a and the indicator socket connectors 212b. The socket
connectors 212a may
extend through the first side 216. The first side 216 is configured to mate
against the first portion
140e such that the pins 200 can extend into socket connectors 212a and the
indicator pins 202
extend into the indicator socket connectors 212b. Opening(s) 218a and 218b can
be provided
between the first side 216 and the indicator socket connectors 212b to permit
the indicator pins
202 to pass into and engage with the indicator socket connectors 212b. The
socket connectors
212a may be flush with the first side 216 (or spaced a first distance from the
first side 216), and
the indicator socket connectors 212b may be spaced a second distance 220 from
the first side
216. The second distance 220 is greater than the first distance that the
socket connectors 212a
are spaced from the first side 216 to cause disconnection of the indicator
socket connectors 212b
from the indicator pins 202 prior to disconnection of the pins 200 from the
socket connectors
212a. In some embodiments, two or more indicator pins 202 may form one or more
monitoring
circuits 210a (e.g., simple circuit, series circuit) across the first portion
140e of the connector 42e
and the second portion 142e of the connector 42e.
[0090] In some embodiments, the indicator pins 202 may be connected to the
first portion 140e
of the connector 42e and corresponding indicator socket connectors 212b may be
connected to
the second portion 142e of the connector 42e. One or more conductive lines 214
may be
provided between indicator socket connectors 212b within the second portion
142e. Current
may be provided by controller 85, distal circuit 40, hub 30, electric field
generator 20, an external
source, or combinations thereof. To that end, when the indicator pins 202 are
nnatingly engaged
within the indicator socket connectors 212b, a monitoring circuit 210a (i.e.,
closed circuit) may
be formed. If one or more indicator pins 202 become disconnected from the
indicator socket
connectors 212b, the monitoring circuit 210a is broken and current does not
flow through the
second portion 142e of the connector 42e. Monitoring for changes in current
along the
monitoring circuit 210a may provide status of the connector 42e by
disconnecting the one or
more indicator pin(s) 202 from the associated indicator socket connector 212b
prior to
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disconnection of the pins 200 from the associated socket connectors 212a
(e.g., a partial
disconnection).
[0091] Referring to FIGS. 5D, 5E and 5F, in some embodiments, an indicator
system 260 (as
described above for FIGS. 4D and 4E) is provided with circuitry that may be
configured to provide
data, status, conditions, actions, commands or combinations thereof to a user
and/or patient.
[0092] Referring now to FIG. 5G, shown therein is an exemplary embodiment of a
system 10a
constructed in accordance with the present disclosure. The system 10a is
constructed similar to
the system of FIG. 4A with the exception that the connector 42a is reversed
and shown as
connector 42f having only four (4) electrical connectors 200 and at least one
of the single
indicator pin 202. The connector 42f includes the first portion 140 having the
first distal circuit
40 integrated therein and the second portion 142. The first portion 140,
having the first distal
circuit 40, receives each of the signal 110b, and processes each of signal
110b into the signals
250a-d. As discussed above (referring to FIG 58 and FIG 5C), the four signals
250a-d traverse the
connector 42f: the first signal 250a for the AC current that goes to the
electrode elements 52,
the second signal 250b for data that travels between the UART 86 and the hub
30; the third
signal 250c for power to the distal circuit 40, and the fourth signal 250d for
ground for the distal
circuit 40.
[0093] An exemplary method for using the system 10 in accordance with the
present disclosure
is herein described. In a first step, one or more electrode elements 52 may be
affixed to a body
of a patient. In a second step, one or more pins 200 may be nnatingly
connected to one or more
socket connectors 212a. Additionally, one or more indicator pins 202 may be
nnatingly connected
to one or more indicator socket connectors 212b. In a third step, current may
be provided to one
or more indicator pins 202. In a fourth step, the controller 85, hub 30,
electric field generator 20,
or combinations thereof may monitor feedback from the current provided to the
one or more
indicator pins 202 during use of the system 10 via instrument 213 in obtaining
one or more
temperature readings and providing TTFields. For example, the controller 85
may monitor
changes in voltage across one or more resistor RI to monitor feedback from the
current provided
to the one or more indicator pins 202 as described herein. In a fifth step,
the hub 30, or the
electric field generator 20 may determine status of the connector 42 based on
feedback from
the current provided to the one or more indicator pins 202. For example, if
the voltage is at 0,
the determination of the status of the connector 42 may be that the first
portion 140 of the
connector 42 is disconnected from the second portion 142 of the connector 42.
In a sixth step,
one or more indicators, and, optionally, actions, commands, data, or
combinations thereof may
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be provided to a user and/or the patient. For example, the one or more
indicators may provide
status of the connector 42 and/or provide recommended actions appropriate to
ensure
continued use of the connector 42.
[0094]Optionally, if disconnection or partial disconnection is detected, a
signal from the
monitoring circuit 210 or the indicator system 260, may receive a first signal
indicative of the
status of the connector of "disconnection" or "partial disconnection" of the
first portion and the
second portion and a second signal may be sent to the electric field generator
20 to effect the
predetermined action, such as powering down of the electric field generator
20. The electric field
generator 20 may be provided with a power-down circuit configured to receive
the signal and
cause the powering down of the electric field generator 20. The power down
circuit can be an
analog to digital converter coupled to an interface of a microprocessor, or a
relay.
[0095] In some embodiments, an optional step may include disconnecting the
first portion 140
of the connector 42 and the second portion 142 of the connector 42 (i.e., pins
200 may be
disconnected from socket connectors 212a and indicator pins 202 may be
disconnected from
indicator socket connectors 212b), such that the electrode elements 52 may be
sanitized and/or
cleaned. The first portion 140 of the connector 42 may then be reconnected to
the second
portion 142 of the connector 42.
NON-LIMITING ILLUSTRATIVE EMBODIMENTS OF THE INVENTIVE CONCEPT(S)
[0096]The following is a number list of non-limiting illustrative embodiments
of the inventive
concept disclosed herein:
[0097]Illustrative Embodiment 1. An apparatus for imposing electric fields
through a target
region in a body of a patient, the apparatus comprising:
at least one transducer array having a plurality of electrode elements
configured for
placement on the body of the patient, the electrode elements configured to
provide TTFields; and
a connector electrically connected to the at least one transducer array,
wherein the
connector has at least one associated monitoring circuit configured to provide
feedback related to a status of the connector.
[0098] Illustrative Embodiment 2. The apparatus of Illustrative Embodiment 1,
wherein the
connector has a plurality of pins or socket connectors in electrical
communication with the
transducer array, and wherein at least one of the pins or socket connectors is
an indicator
electrical connector.
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[0099] Illustrative Embodiment 3. The apparatus of Illustrative Embodiment 2,
wherein the
connector further comprises:
a first portion, wherein the indicator electrical connector is an indicator
pin integrated
into the first portion of the connector; and
a second portion including an indicator socket connector associated with the
indicator pin, the indicator socket connector integrated into the second
portion
of the connector.
[0100] Illustrative Embodiment 4. The apparatus of Illustrative Embodiment 3,
wherein the
plurality of pins is integrated into the first portion of the connector and
wherein the second
portion of the connector further includes a plurality of socket connectors
wherein each socket
connector is operable to receive a particular one of the plurality of pins
integrated into the first
portion of the connector.
[0101] Illustrative Embodiment 5. The apparatus of Illustrative Embodiment 3,
wherein a first
length of at least one of the plurality of pins is greater than a second
length of the at least one
indicator pin.
[0102] Illustrative Embodiment 6. The apparatus of Illustrative Embodiment 4,
wherein a first
depth of the plurality of socket connectors is greater than a second depth of
the indicator socket
connector.
[0103] Illustrative Embodiment 7. The apparatus of Illustrative Embodiment 6,
wherein the
connector further includes a first end and a second end with the indicator pin
positioned at the
first end of the connector.
[0104]Illustrative Embodiment 8. The apparatus of Illustrative Embodiment 3,
further
comprising at least one resistor in electrical communication with the
indicator socket connector,
wherein feedback related to the status of the connector includes voltage
changes at the at least
one resistor.
[0105] Illustrative Embodiment 9. The apparatus of Illustrative Embodiment 3,
wherein the
connector further includes at least two indicator pins, a first end, and a
second end, wherein at
least one indicator pin is positioned at the first end of the connector and at
least one indicator
pin is positioned at the second end of the connector.
[0106]Illustrative Embodiment 10. The apparatus of Illustrative Embodiment 9,
further
comprising a conductive line positioned between at least two indicator socket
connectors
forming a monitoring circuit.
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[0107] Illustrative Embodiment 11. The apparatus of Illustrative Embodiment
10, wherein a
controller is configured to determine the status of the connector via the
monitoring circuit.
[0108] Illustrative Embodiment 12. The apparatus of Illustrative Embodiment
11, wherein the
controller determines the status of the connector by monitoring changes to
current within the
monitoring circuit or by monitoring changes to voltage within the monitoring
circuit.
[0109] Illustrative Embodiment 13. The apparatus of Illustrative Embodiment 1,
wherein the at
least one monitoring circuit is configured to generate a signal indicative of
the status of the
connector, and further comprising an indicator system configured to receive
the signal and
provide at least one of visual, auditory or haptic feedback to a user on the
status of the
connector.
[0110]Illustrative Embodiment 14. The apparatus of Illustrative Embodiment 1,
further
comprising an electric field generator, wherein the connector includes a first
portion configured
to be connected to a second portion, and wherein the status of the connector
is "disconnection"
or "partial disconnection" of the first portion from the second portion, and
wherein the
monitoring circuit is configured to generate a signal indicative of the status
of the connector of
"disconnection" or "partial disconnection" of the first portion and the second
portion, and
further wherein the electric field generator receives a signal that indicates
the status of the
connector of "disconnection" or "partial disconnection" of the first portion
and the second
portion and powers down the electric field generator.
[0111] Illustrative Embodiment 15. A method for monitoring an apparatus for
imposing electric
fields through a target region in a body of a patient, the method comprising:
electrically connecting a connector to the at least one transducer array,
wherein the at
least one transducer array has a plurality of electrode elements configured
for placement on the
body of the patient, the electrode elements configured to provide TTFields;
circulating current through at least one indicator pin integrated into a first
portion of the
connector, and an associated indicator socket connector integrated into a
second
portion of the connector;
monitoring data from the circulating current;
determining status of the connector based on the monitored data; and,
providing a predetermined action based on the status of the connector.
[0112] Illustrative Embodiment 16. The method of Illustrative Embodiment 15,
wherein the
predetermined action is providing at least one of visual indicator, auditory
indicator, or haptic
indicator of the status of the connector to a user.
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[0113] Illustrative Embodiment 17. The method of Illustrative Embodiment 15,
wherein the
connector is configured to be connected to an electric field generator, and
wherein the status of
the connector is "disconnection" or "partial disconnection" of the at least
one indicator pin from
an associated indicator socket connector, and wherein the predetermined action
is powering
down the electric field generator.
[0114] Illustrative Embodiment 18. A system comprising:
a plurality of transducer arrays each having substrate supporting a plurality
of electrode
elements configured for placement on a body of a patient, the electrode
elements
configured to provide TTFields and at least one electrode element associated
with
a temperature sensor; each transducer array electrically connected to a first
side
of a connector, and each transducer array comprising a distal circuit
electrically
coupled to each of the plurality of electrode elements of the transducer array
and
operable to receive a temperature signal from each of the associated
temperature sensors and operable to output a DATA signal and to receive a
TTField Signal, the distal circuit being either supported by the substrate, or
integrated into the first side of the connector, or both, or positioned in a
circuit
between the transducer array and the connector, the connector further
comprising a plurality of pins or socket connectors in electrical
communication
with the transducer array; and, at least one monitoring circuit configured to
provide feedback related to a status of the connector;
a hub electrically coupled to each of the plurality of transducer arrays; and
an electric field generator electrically coupled to the hub and operable to
receive one or
more DATA signal and output one or more TTField Signal.
[0115]Illustrative Embodiment 19. The system of Illustrative Embodiment 18,
wherein the
connector further comprises a first end and a second end; and wherein the
monitoring circuit is
coupled to at least one indicator electrical connector comprising a first
indicator pin and a second
indicator pin, the first indicator pin positioned at the first end of the
connector and the second
indicator pin positioned at the second end of the connector; the connector
further comprising a
conductive line positioned between at least two indicator socket connectors
forming the
monitoring circuit configured to determine the status of the connector.
[0116]Illustrative Embodiment 20 The system of Illustrative Embodiment 18
wherein the
monitoring circuit generates a signal indicative of the status of the
connector of "disconnection"
or "partial disconnection" of the first portion and the second portion, and
wherein the electric
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field generator receives a signal that indicates the status of the connector
of "disconnection" or
"partial disconnection" of the first portion and the second portion and powers
down the electric
field generator.
[0117] Illustrative Embodiment 21. A connector for use in a TTField system,
comprising:
a first portion having:
a plurality of pins integrated into the first portion and configured to be
electrically
connected to an array of transducers; and,
at least one indicator pin integrated into the first portion, the at least one
indicator pin
having a first length less than a second length of at least one of the
plurality of
pins.
[0118] Illustrative Embodiment 22. A method, comprising:
circulating current through at least one indicator pin integrated into a first
portion of a
connector, and an associated indicator socket connector integrated into a
second
portion of a connector;
monitoring data from the circulating current;
determining status of the connector based on the monitored data; and,
providing at least one visual indicator of the status of the connector to a
user.
[0119] Illustrative Embodiment 23. A connector for use in a TTField system,
comprising:
a first portion having:
a plurality of electrical connectors integrated into the first portion and
configured to be
electrically connected to an array of transducers; and,
at least two indicator electrical connectors integrated into the first
portion; and
a conductor electrically connecting the two indicator electrical connectors.
[0120] Illustrative Embodiment 24. An apparatus for use in a TTF field system,
comprising:
at least one transducer array having a plurality of electrode elements
configured for
placement on a body of a patient, the electrode elements configured to provide
TTFields;
a connector electrically connected to the at least one transducer array, the
connector
having a first portion comprising:
a plurality of electrical connectors in electrical communication with the
transducer array;
and,
at least one indicator electrical connector electrically isolated from the
transducer array,
and configured to provide feedback related to a status of the connector.
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[0121] While the present invention has been disclosed with reference to
certain embodiments
and illustrations, numerous modifications, alterations, and changes to the
described
embodiments or illustrations are possible without departing from the spirit
and scope of the
present invention, as defined in the appended claims. Accordingly, it is
intended that the present
invention not be limited to the described embodiments and illustrations, but
that it has the full
scope defined by the language of the following claims, and equivalents
thereof.
[0122]The foregoing description provides illustration and description, but is
not intended to be
exhaustive or to limit the inventive concepts to the precise form disclosed.
Modifications and
variations are possible in light of the above teachings or may be acquired
from practice of the
methodologies set forth in the present disclosure.
[0123] Even though particular combinations of features and steps are recited
in the claims
and/or disclosed in the specification, these combinations are not intended to
limit the disclosure.
In fact, many of these features and steps may be combined in ways not
specifically recited in the
claims and/or disclosed in the specification. Although each dependent claim
listed below may
directly depend on only one other claim, the disclosure includes each
dependent claim in
combination with every other claim in the claim set.
[0124] Similarly, although each illustrative embodiment listed above may
directly depend on
only one other illustrative embodiment, the disclosure includes each
illustrative embodiment in
combination with every other illustrative embodiment in the set of
illustrative embodiments for
the inventive concepts disclosed herein.
[0125] No element, act, or instruction used in the present application should
be construed as
critical or essential to the invention unless explicitly described as such
outside of the preferred
embodiment. Further, the phrase "based on" is intended to mean "based, at
least in part, on"
unless explicitly stated otherwise.
32
