U.S. patent application number 16/177913 was filed with the patent office on 2019-04-25 for apparatus and method for treating multiple tumors in patients with metastatic disease by electric fields.
This patent application is currently assigned to Loyalty Based Innovations, LLC. The applicant listed for this patent is Loyalty Based Innovations, LLC. Invention is credited to Scott Krywick, Matthew Travers, Peter F. Travers, Ken Watkins.
Application Number | 20190117963 16/177913 |
Document ID | / |
Family ID | 66169651 |
Filed Date | 2019-04-25 |
![](/patent/app/20190117963/US20190117963A1-20190425-D00000.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00001.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00002.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00003.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00004.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00005.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00006.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00007.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00008.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00009.png)
![](/patent/app/20190117963/US20190117963A1-20190425-D00010.png)
View All Diagrams
United States Patent
Application |
20190117963 |
Kind Code |
A1 |
Travers; Peter F. ; et
al. |
April 25, 2019 |
APPARATUS AND METHOD FOR TREATING MULTIPLE TUMORS IN PATIENTS WITH
METASTATIC DISEASE BY ELECTRIC FIELDS
Abstract
An electronic device for delivering a plurality of tumor
treating electromagnetic fields to a patient including a plurality
of electrode elements each being independently programmable, a
control device and a field generator. The control device is
configured to dynamically program a frequency range, a firing
configuration and a firing sequence for the plurality of electrode
elements. The field generator generates electrical signals in the
frequency range, the electrical signals being directed to at least
two of the plurality of electrode elements. The plurality of
electrode elements including both master and slave electrode
elements.
Inventors: |
Travers; Peter F.;
(Longwood, FL) ; Watkins; Ken; (Lake Mary, FL)
; Krywick; Scott; (Clermont, FL) ; Travers;
Matthew; (Apopka, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Loyalty Based Innovations, LLC |
Longwood |
FL |
US |
|
|
Assignee: |
Loyalty Based Innovations,
LLC
Longwood
FL
|
Family ID: |
66169651 |
Appl. No.: |
16/177913 |
Filed: |
November 1, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15826112 |
Nov 29, 2017 |
|
|
|
16177913 |
|
|
|
|
14795597 |
Jul 9, 2015 |
9833617 |
|
|
15826112 |
|
|
|
|
62028996 |
Jul 25, 2014 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/40 20130101; A61N
1/0476 20130101; A61N 1/37217 20130101; A61N 1/32 20130101 |
International
Class: |
A61N 1/32 20060101
A61N001/32; A61N 1/40 20060101 A61N001/40; A61N 1/372 20060101
A61N001/372; A61N 1/04 20060101 A61N001/04 |
Claims
1. An electronic device for delivering a plurality of tumor
treating electromagnetic fields to a patient, comprising: a
plurality of electrode elements each being independently
programmable; a control device configured to dynamically program a
frequency range, a firing configuration and a firing sequence for
the plurality of electrode elements; and a field generator
generating electrical signals in the frequency range, the
electrical signals being directed to at least two of the plurality
of electrode elements, the plurality of electrode elements
including both master and slave electrode elements.
2. The electronic device of claim 1, wherein each of the master
electrode elements is connected to at least one of the slave
electrode elements.
3. The electronic device of claim 2, wherein each of the master
electrode elements is connected to a plurality of the slave
electrode elements.
4. The electronic device of claim 2, wherein the master electrode
elements are each connected to a differing set of the slave
electrode elements by way of wires from each of the master
electrode elements to the corresponding set of the slave electrode
elements.
5. The electronic device of claim 4, wherein each of the master
electrode elements directly control each of the slave electrode
elements in the set of the slave electrodes that are connected to
the master electrode element by way of the wires.
6. The electronic device of claim 5, wherein each of the master
electrode elements is in communication with the control device.
7. The electronic device of claim 6, wherein the firing
configuration is conveyed to at least one of the master electrode
elements from the control device.
8. The electronic device of claim 7, wherein the firing
configuration of the slave electrode elements coupled to the at
least one of the master electrode elements is controlled by the at
least one of the master electrode elements by directing the
electrical signals from the field generator to selected ones of the
slave electrode elements.
9. The electronic device of claim 8, wherein the at least one
master electrode element can deliver the electric signal to the
patient.
10. The electronic device of claim 8, wherein a combination of the
master electrode elements and the slave electrode elements deliver
the electric signal to the patient.
11. A method of using an electrode array to deliver tumor treating
electric fields to a patient, comprising the steps of: placing a
plurality of electrode elements in optimized locations on the
patient, each of the electrode elements being independently
programmable; dynamically programming a control device with a
frequency range, a firing configuration and a firing sequence for
the plurality of electrode elements; and generating electrical
signals with a field generator in the frequency range, the
electrical signals being directed to at least two of the plurality
of electrode elements, the plurality of electrode elements
including both master and slave electrode elements.
12. The method of claim 11, wherein each of the master electrode
elements is connected to at least one of the slave electrode
elements.
13. The method of claim 12, wherein each of the master electrode
elements is connected to a plurality of the slave electrode
elements.
14. The method of claim 12, wherein the master electrode elements
are each connected to a differing set of the slave electrode
elements by way of wires from each of the master electrode elements
to the corresponding set of the slave electrode elements.
15. The method of claim 14, wherein each of the master electrode
elements directly control each of the slave electrode elements in
the set of the slave electrodes that are connected to the master
electrode element by way of the wires.
16. The method of claim 15, wherein each of the master electrode
elements is in communication with the control device.
17. The method of claim 16, wherein the firing configuration is
conveyed to at least one of the master electrode elements from the
control device.
18. The method of claim 17, wherein the firing configuration of the
slave electrode elements coupled to the at least one of the master
electrode elements is controlled by the at least one of the master
electrode elements by directing the electrical signals from the
field generator to selected ones of the slave electrode
elements.
19. The method of claim 18, wherein the at least one master
electrode element can deliver the electric signal to the
patient.
20. The method of claim 18, wherein a combination of the master
electrode elements and the slave electrode elements deliver the
electric signal to the patient.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation-in-part application based upon U.S.
non-provisional patent application Ser No. 15/826,112, entitled
"APPARATUS AND METHOD FOR TREATING MULTIPLE TUMORS IN PATIENTS WITH
METASTATIC DISEASE BY ELECTRIC FIELDS", filed Nov. 29, 2017, which
is incorporated herein by reference. U.S. non-provisional patent
application Ser. No. 15/826,112 is a divisional application based
upon U.S. non-provisional patent application Ser. No. 14/795,597,
entitled "APPARATUS AND METHOD FOR TREATING MULTIPLE TUMORS IN
PATIENTS WITH METASTATIC DISEASE BY ELECTRIC FIELDS", which was
filed Jul. 9, 2015, and has issued as U.S. Pat. No. 9,833,617 on
Dec. 5, 2017. U.S. non-provisional patent application Ser. No.
14/795,597 is based upon U.S. provisional patent application Ser.
No. 62/028,996, entitled "APPARATUS AND METHOD FOR TREATING
MULTIPLE TUMORS IN PATIENTS WITH ADVANCED METASTATIC DISEASE BY
ELECTRIC FIELDS", filed Jul. 25, 2014.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates to tumor and cancer cell
treatment and more specifically to treatments involving the
application of electromagnetic fields.
2. Description of the Related Art
[0003] Alternating Electric Fields, also referred to as Tumor
Treating Fields (TTF's), can be employed as a type of cancer
treatment therapy by using low-intensity electromagnetic fields.
These low-intensity fields rapidly change direction, thousands of
times per second. Since the TTF's are electric fields, they do not
cause muscle twitching or severe adverse side effects on other
electrically activated tissues. The growth rate of metastatic
diseases is typically greater than the growth rate of normal,
healthy cells. Alternating Electric Fields therapy takes advantage
of this high growth-rate characteristic. TTF's act to disrupt a
cancer cell's mitotic process and cytokinesis by manipulating the
cell's polarizable intracellular constituents, namely tublins that
form mitotic spindles that pull the genetic material in the nucleus
into two sister cells. TTF's interrupt mitotic spindle microtubule
assembly thereby preventing cell division. The metastatic disease
cells treated using TTF's will go into programmed cell death
usually within 4 to 5 hours. The result is a significant reduction
in tumor size and potential for full elimination of solid tumors.
TTF's are tuned to treat specific cancer cells and thereby do not
damage normal cells. TTF therapy can be used as a sole treatment
method, or it can be combined with conventional drug delivery
mechanisms.
[0004] TTF's are applied to patients using insulated electrodes
adhered to the skin by a variety of methods including the use of
medical adhesives, articles of clothing, etc. There are multiple
configurations of insulated electrodes, but all have an insulated
material with a high dielectric constant on one side and a thin
metal coating on the other, usually silver. Insulated electrodes
used to generate TTF's always come in pairs with both sides being
similar, but not necessarily the same.
[0005] What is needed in the art, is a TTF system that enables the
dynamic reassignment of array elements to thereby define any array
needed and to apply the field from selected electrode elements.
[0006] What is needed in the art is a modular system for adding and
removing array elements.
[0007] What is needed in the art is a current monitoring sensor
that sends a shut off signal to the control device if fluctuations
in current, which may be caused by current leakage to the skin or
the detachment of the electrode, is detected.
[0008] What is needed in the art is a method of adhering array
elements to a material while also reducing the temperature of the
array elements.
SUMMARY OF THE INVENTION
[0009] The present invention provides an improved cancer and tumor
treatment regime.
[0010] The invention in one form is directed to an electronic
device for delivering a plurality of tumor treating electromagnetic
fields to a patient including a plurality of electrode elements
each being independently programmable, a control device and a field
generator. The control device is configured to dynamically program
a frequency range, a firing configuration and a firing sequence for
the plurality of electrode elements. The field generator generates
electrical signals in the frequency range, the electrical signals
being directed to at least two of the plurality of electrode
elements. The plurality of electrode elements including both master
and slave electrode elements.
[0011] The invention in another form is directed to a method of
using an electrode array to deliver tumor treating electric fields
to a patient including the steps of: placing a plurality of
electrode elements in optimized locations on the patient, each of
the electrode elements being independently programmable;
dynamically programming a control device with a frequency range, a
firing configuration and a firing sequence for the plurality of
electrode elements; and generating electrical signals with a field
generator in the frequency range, the electrical signals being
directed to at least two of the plurality of electrode elements,
the plurality of electrode elements including both master and slave
electrode elements.
[0012] An advantage of the present invention is that connected sets
of master and slave electrode elements are used to deliver
programed electric signals to selected electrodes attached to the
patient. The arrangement of which reduces the cost of the electrode
arrays.
[0013] Another advantage of the present invention is that it allows
for less warming of a patient's skin from individual
electrodes.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The above-mentioned and other features and advantages of
this invention, and the manner of attaining them, will become more
apparent and the invention will be better understood by reference
to the following description of embodiments of the invention taken
in conjunction with the accompanying drawings, wherein:
[0015] FIG. 1 is a flowchart illustrating an embodiment of a
treatment method of the present invention;
[0016] FIG. 2A illustrates a firing of selected array elements of
prior art systems;
[0017] FIG. 2B illustrates a firing of another selection of array
elements by a prior art system;
[0018] FIG. 3A illustrates a firing of individual programmable
array elements of an array of elements to treat a tumor in a
patient of the present invention, using the method of FIG. 1;
[0019] FIG. 3B illustrates a firing of other individual
programmable array elements of the array of elements of FIG.
3A;
[0020] FIG. 3C illustrates a firing of still other individual
programmable array elements of the array of elements of FIGS. 3A
and 3B;
[0021] FIG. 3D illustrates a firing of yet still other individual
programmable array elements of the array of elements of FIG.
3A-3C;
[0022] FIG. 3E illustrates sub-arrays of individual programmable
array elements;
[0023] FIG. 4 is a flowchart of steps of another embodiment of a
treatment process of the present invention;
[0024] FIG. 5A illustrates an embodiment of a method of
deactivating a selected array element of the present invention;
[0025] FIG. 5B illustrates an embodiment of a method of activating
a selected array element of the present invention;
[0026] FIG. 6 is a flowchart illustrating an embodiment of a
treatment method of the present invention;
[0027] FIG. 7A illustrates an array of electrode elements arranged
in selected physical locations;
[0028] FIG. 7B illustrates a device used to clean and apply
adhesive to the electrode elements;
[0029] FIG. 7C illustrates multiple arrays of the electrode
elements;
[0030] FIG. 7D illustrates the nozzle directing device to clean and
apply adhesive to the electrode elements held in retaining
racks;
[0031] FIG. 8 illustrates another method of the present invention
to modify the patient experience;
[0032] FIG. 9A illustrates the making of an electrode;
[0033] FIG. 9B further illustrates the making of an electrode;
[0034] FIG. 9C still further illustrates the making of an
electrode;
[0035] FIG. 9D yet still further illustrates the making of an
electrode;
[0036] FIG. 10A illustrates a coupling of the field generator to a
subarray of electrodes;
[0037] FIG. 10B illustrates another coupling of the field generator
to a subarray of electrodes;
[0038] FIG. 11 illustrates an embodiment of the present invention
in which each electrode element is coupled to the field/wave
generator;
[0039] FIG. 12 is a diagram illustrating another embodiment in
which signals from the field generator are coupled to the
electrodes;
[0040] FIG. 13A illustrates one manner in which the electrodes are
positioned on a torso of the patient;
[0041] FIG. 13B illustrates the positioning of a garment with
electrodes on a patient;
[0042] FIG. 14 presents another method of the present invention;
and
[0043] FIG. 15 illustrates an embodiment of a series of electrodes
of the present invention having flexible wiring therebetween.
[0044] Corresponding reference characters indicate corresponding
parts throughout the several views. The exemplifications set out
herein illustrate embodiments of the invention and such
exemplifications are not to be construed as limiting the scope of
the invention in any manner.
DETAILED DESCRIPTION OF THE INVENTION
[0045] Referring to the drawings and more particularly to FIG. 1
there is illustrated an embodiment of a treatment method 100 of the
present invention for preparing to treat a patient. One important
step in administering tumor treating fields (TTF) is positioning
electric fields to target multiple tumors in the human body. The
present invention uses a process for optimizing the placement of
array elements on the body as well as an optimal firing sequence
for the array elements, to take advantage of the placement of the
elements. First at step 102, a 3-D scan is made of the entire
patient's body or at least a portion that includes the tumors to be
treated. This 3-D scan is then imported into a medical simulator
like Sim4life, at step 104. These medical simulators have phantoms
or avatars that meet general body types of most of the population.
The phantoms are 3-D bodies with all tissue types and organs
simulating the human anatomy. An appropriate 3-D phantom is
selected to match the imported 3-D model of our patient and the
patient model is morphed to the phantom, at step 106. At step 108,
the patient's medical scans such as PET scans or CT scans are
imported into the morphed phantom matching our patient. The result
is a medical simulation of our patient with tumors in the correct
location. At step 110, the medical simulator is used to add TTF
arrays to the simulated 3-D patient. At step 112, a simulated
firing algorithm is run, analyzing which sequence or combination of
array elements optimally treats the tumors in the simulation. The
behavior of electric fields from the TTF is simulated through the
body tissues and organs to evaluate the effectiveness of the
applied electromagnetic fields and to optimize the firing sequence
at step 114. The results of the optimal firing sequence are then
exported to the wave generator. At step 116 the arrays are placed
on the patient accordingly and treatment begins at step 118 using
the firing sequence sent to the wave generator. When needed the
process is repeated (step 120) for changes in body shape from loss
or gaining of weight and or the development of new tumors.
[0046] A significant problem when administering TTF is the
production of heat at the electrode site that can minimize the
effectiveness of the treatment. It is well known by those
experienced in the field that the intensity of the electromagnetic
field administered through TTF has a significant effect on how well
it reduces tumors. Electric fields at the appropriate frequency
traveling through a tumor at 1 V/cm reduces tumor growth but may
not eliminate the tumor. The same electric field at 2 V/cm to 3
V/cm is much more likely to fully eliminate cells in a target
tumor. However, electric fields at the 2 V/cm to 3 V/cm intensities
can produce warmth on the array elements on the skin of the patient
that cannot be tolerated. Indeed, the present form of an FDA
approved device is programed to reduce intensity when array
elements reach 105.8 degrees Fahrenheit. This heating and the
subsequent reduction in field intensity makes the therapy less
effective.
[0047] The present invention overcomes this issue in part by
minimizing the duty cycle of array elements. This is accomplished
by individually controlling each array element and generally places
more discs per square inch on the body than prior art forms of TTF
which only control groups of array elements. For example, now
additionally referring to FIGS. 2A and 2B, prior art TTF devices
may have arrays 202, 204, 206, 208 comprised of 5 rows of 4 discs
(only one row of each being illustrated) placed 3 inches on center
over the front of the chest (array 202) and the same on the back
(via array 204), for the treatment of tumor T. The illustrations
have a single row of elements, for the sake of simplicity in
illustrating, in straight rows, while it is to be understood that
the arrays are actually positioned on the surface of the body. This
pair of arrays is accompanied by a similar pair 206, 208 on the
sides of the body left and right. The typical firing sequences is
front-to-back then side-to-side. This places each array on a 50%
duty cycle (as illustrated in FIGS. 2A and 2B) producing a
significant amount of warming of array elements that must be
managed by turning down electric field intensity levels.
[0048] Now, additionally referring to FIGS. 3A-3D, in contrast to
the prior art, the present invention uses nearly twice the number
of array elements over the same area front-to-back and
side-to-side. FIGS. 3A-3D include arrays 302, 304, 306 and 308,
each with individual references to elements A-H. Again, although
shown schematically in two dimensions with single rows of elements,
the arrays themselves have rows and columns of elements that are
placed on the surface contours of a body, providing a three
dimensional positioning of the elements. Since each element can be
independently and dynamically controlled it is possible to produce
firing sequences that target a given area alternating array
elements. From a macro perspective, this can produce the desired
field with a 25% duty cycle on the array elements making it less
likely they will warm to undesirable temperatures enabling
sustained higher field intensities to more likely eliminate tumor T
by preventing the cells therein from successfully dividing. This is
illustrated in FIGS. 3A-3D by showing elements that are darker as
being the selected elements that are used in each particular
figure. Beyond the wider view of reducing the duty cycle of an
element, the individual control of elements allow the ability to
maintain desired field strengths in tumor T by knowing the relative
positions of each element of each array, so that the wave generator
can select elements that will be used in a selected sequence for
maintaining optimal field strength in the targeted area of tumor T.
For example, the wave generator may select elements 308G and 302H
to produce an electric field therebetween based on the information
gained in steps 102-114 of method 100. Whereas the present
invention has 3-D information about the location and shape of tumor
T, the selection of particular elements of the arrays 302, 304,
306, 308 can be done to ensure that the electromagnetic field
strength in and slightly around tumor T can be maintained, while
the field strength in other parts of the body may be of a reduced
magnitude. To help minimize the duty cycle of array elements they
may be placed in strategic placements, not just parallel rows. For
example, FIG. 3E shows array placement in offset rows (310-312)
which may be more likely to minimize a change in placement of TTF
fields when switching from one row to the next. Such strategic
placement of array elements is included in simulation algorithms
discussed herein.
[0049] Now, additionally referring to FIG. 4, there is illustrated
a flowchart embodying a method 400. Method 400 determines the best
firing sequence to manage warmth and field intensity. The 3-D
simulation process is run to include multiple alternating firing
sequences to produce the same essential electric field coverage
required to target the patient's tumors (see step 116). At step 402
this information is downloaded into the wave generator. The TTF
arrays 302, 304, 306, 308 are then placed on the patient at step
404. Heat sensors on each array element provide real time feedback
and field intensity monitoring. The various firing sequences are
run and monitored in step 406. The sequences that provide the
highest field intensity within temperature parameters are chosen
for treatment and the other sequences are dropped in step 408.
Thereby producing the most tumor reduction per hour of use and if
changes are needed (step 410) method 400 is repeated.
[0050] Regardless of the guidance provided by 3-D simulation in
positioning array elements for TTF on a patient's body, actual
application will require adjustments. This can occur for many
reasons, such as a change in the patient's weight, that has not yet
been compensated for by re-running the 3-D simulation, the
occurrence of peripheral nerve stimulation in isolated spots on the
abdomen, or difficult to correct errors in placement with medical
adhesives. The present invention provides for individual array
elements to be turned on and off to adjust for such occurrence
without having to adjust entire arrays. This is accomplished by
identifying the address of an array element and making a computer
entry to selective turn off and on array elements, which may be a
somewhat tedious task. To streamline this process the present
invention provides for the use of a magnetic tool MT that is swept
over the top of an array element in close proximity. The magnetic
tool MT interacts with sensors built into the array elements and
removes the element from active duty (see FIG. 5A) or enters it
into active duty (See FIG. 5B) depending on the need. The magnetic
tool MT is directional in that sweeping in one direction, say left
to right, as in FIG. 5A in direction D1, removes an element from
active duty and right to left, as in FIG. 5B in direction D2,
enters it into active duty. It is also contemplated to educate the
patient to enable/disable some elements using this method if
particular elements seem problematic to the patient. It is
contemplated that the wave generator will compensate for the
enabled/disable elements so that effective treatment continues in
light of the reconfigured elements.
[0051] The best way to minimize the need for adjustments of array
element placement is to place them correctly for each
treatment--the first time before each day's treatment. Surprisingly
this can be problematic due to changes in posture during the
application, or movements made while array elements are being
placed. These can cause incorrect starting positions which are then
spread down the entire array. To minimize the likelihood of these
type of problems the present invention includes an image marker
system consisting of a small projector, floor markers and permanent
or temporary tattoos. As illustrated in FIG. 6, a method 600
includes determining the patient's treatment posture at step 602;
placing the array in an optimal position at step 604; applying at
least 6 tattoo dots on the patient's body at step 606, 2 at
shoulder level and one at the lower abdomen in the front, for
example, and 3 on the back. At step 608 the patient is then
positioned for a precision photograph. Floor markings are made to
record foot placement. A precision image is made with camera
distant, lens type and strength, etc., all recorded. A projector is
then mounted in the correct position from the foot markings (step
610). Each day the patient steps (step 612) in front of the
projector which projects on image (step 614) of the arrays onto the
body. The patient repeatedly repositions (step 616) until the
tattoo dots from the projected image line up with actual tattoos
dots on the body. This lines up the image of the arrays to where
they should be placed on the patient's body. The arrays are then
placed using the image as a placement guide (step 618).
[0052] Now, additionally referring to FIGS. 7A-7D, one of the
challenges of long term TTF therapy is patient compliance. Adding
to the need to wear the device daily is the requirement of daily
washing, drying and application of medical adhesive. To minimize
the burden of this task our engineers have invented an apparatus
700 that accomplishes all three. A key component of the apparatus
is a semi flexible portable holding rack 704 that is not only used
to prepare for maintenance but is also used to re-secure the array
elements 706 on the patient's body for the new day's therapy (not
shown). For reapplying the arrays 702 the portable semi flexible
rack 704 is held against the patient's body at the appropriate
location and then gently bowed inward by pulling out on each side
(not shown). The array elements 706 then pop out of the portable
rack 704 and adhere to the patient's skin via the medical adhesive
(not shown). An apparatus 710 is comprised of a chamber with a
removable securing rack 718 that holds the flexible racks 720,
movable application nozzles 734 that apply both water for washing
and medical adhesive for skin adhering and drying fans 712, 714 and
716, and a drain for water removal. The apparatus 710 can be
permanently mounted with a plumbed water supply and electric source
(not shown). Perhaps near the household washer where both water,
drain and electricity are available. At the end of each day's
treatment the arrays are placed in the portable racks 722. The
portable racks 722 are then placed in the securing racks. The
securing rack is brought to the area where the TTF maintenance will
be done. The securing rack with the arrays is then placed in the
apparatus at 718, the door is closed and sealed. The system 710 is
activated, with movable nozzles 734 controlled and programed to
move over the array elements 702 with ample warm water to remove
the medical adhesive from the last therapy session. Once the array
elements 706 are clean and the apparatus is drained, a drying
sequence begins using imbedded fans 712, 714, 716. Once dry the
arrays are allowed to sit to return to room temperature. The
precision nozzles 734 then move over the discs 706 spraying them
with the medical adhesive. The drying fans 712, 714, 716 are
activated to dry the medical adhesive. The racks 720 containing the
arrays can then be removed and placed conveniently wherever the
patient puts on the arrays for the next day's treatment. In some
configurations the apparatus is equipped with tanks 732 to hold
medical adhesive, clean water and drainage water. In some
configuration there are drain lines and supply lines form outside
the apparatus 710.
[0053] As patients wear TTF behavior patterns emerge which can be
used to improve care through qualitative research. Applicant has
developed a process 800 whereby the wave generator controller (or
computer) records daily activity (step 802), such as start and stop
times, middle of the night interruptions, temperature readings,
firing configuration, etc. The computer within the wave generator
generates daily and weekly reports (step 804). When enough data is
gathered a master, report is generated highlighting patterns of
interruptions (step 806). The data is then used to create a
qualitative survey (step 808) used to guide on interview with the
patient. Interview questions like the following can be developed,
"the report shows a repeated interruption of therapy between 4 am
and 7 am most nights. Let me ask you what is problematic, or
frustrated, or uncomfortable during that time period that makes you
pause therapy?" The input from the patient can then be used to
solve problems and hopefully improve therapy (step 810).
[0054] As previously mentioned one of the challenges of delivering
TTF therapy is managing warmth on array elements. The goal is to
keep the arrays as close to natural skin temperature as possible.
Applicant's advanced form of TTF is has array elements 706 that are
not exposed to open air, but instead have printed circuit boards on
the non-skin side or a flex circuit, both of which hold the
electronics required for dynamic reassignment of array elements.
The printed circuit board or flex circuit is the then encapsulated
with thermal conductive material. The layers of the array elements
706 then are as follows: Ceramic disc or material with conductive
layer on one side, circuit board, thermal conductive potting
material around the entire top of the element and the side as well,
but not on the side that adheres to the patient's skin. The problem
is that the warmth from the discs is trapped by the circuit board
which is not thermally conductive. The warmth from the disc can
only travel out the side up and around the circuit boards, causing
a slow release or a bottleneck of warmth release. To combat this
problem Applicant has developed a unique solution made of super
thermally conductive, thin sheeting material. Some of these
materials have 2 to 5 times the thermal conductivity of copper.
This thin sheeting is cut into a star donut shape 904 with the body
of the donut extending further out than the diameter of the hole.
The diameter of the hole in the thermal conductive sheeting
material is smaller than the diameter of the TTF array element with
its conductive layer 908 and ceramic layer 910. The donut shape
then has triangle shapes removed around its circumference. The tip
of each removed triangle is facing the hole of the triangle, but
does not reach the edge of the hole. The result is somewhat like a
star shaped sheet of thermal conductive sheeting with a hole 906 in
the middle. During construction of the array elements 706 the star
shaped thermal sheeting 908 is centered on the flex circuit board
in hole 906 under the ceramic array element 910. The hole in the
middle allows current to energize the non-skin side of the ceramic
to form the electric field for TTF. Once adhered the printed
circuit board or flex circuit is mounted and secured to the disc
902. A thin coat of thermal conductive potting material is then
used to encapsulate the array element (not shown). The extended
points of the star shaped thermal sheeting are folded down and over
the circuit board top coming together completely covering the array
element (FIGS. 9B-9D). Then a final layer of thermal conductive
potting material is used to cover the entire array element 706 (not
shown). The result is an imbedded thermal conductive pathway for
warmth to travel around the printed circuit board where it can be
dissipated.
[0055] In yet another embodiment of the device the array elements
706 include both slave 1002 and fully dynamic 1004 electrodes, as
illustrated in FIG. 10A. This can lower the cost of the overall
array. In this embodiment each array element 706 is fully equipped
with a microprocessor and all the added electronics described
herein. In this embodiment the electronics, including, but not
limited to sensors, LEDs, microprocessors, etc., are only placed on
master elements 1004. These master elements 1004 then control slave
elements 1002 through direct wires 1006 that supply power and
sensory data. The masters 1004 control any number of slave 1002
array elements, for example, a row of 7 discs could have one master
disc 1004 and then ample wires 1006 running to the 6 slave discs
1002. The master array element 1004 with its microprocessor would
control the 6 slaves 1002 directing them to fire active or be a
return. The slaves 1002 can extend in any direction from master
disc 1004. The slaves 1002 may house limited sensors like a heat
sensor connected by wire to the master 1004. FIG. 10B illustrates
another distributed system where a master 1008, which may not be an
electrode disc, controls slaves 1002.
[0056] In yet another embodiment of the present invention the
controls 1106 associated with master elements described above and,
on each disc, described in our patent are placed in the wave
generator (also referred to herein as a field generator) 1102 to
dynamically control rows 1104 of array elements rather than
individual elements (as illustrated in FIG. 11). This embodiment
offers economic benefit in cases where more granular control of
individual elements is not needed as controls protected inside the
wave generator 1102 should have a longer life.
[0057] A potential problem with delivering the most therapeutic
portion of TTF at the most effective and safe intensities is the
accidental occurrence of Peripheral Nerve Stimulation (PNS). This
is not caused by any current but by the TT Field itself at higher
levels of intensity. The occurrence of PNS can be unpredictable as
each person has their own tolerance of the TT Fields. A large male
may experience no PNS at higher intensities while a petite female
may have considerable. The current solution to this problem is to
throttle back the intensity of the TT Field eliminating the PNS,
but this can sacrifice the most therapeutic level of TTF therapy.
Applicant's solution is that the present invention turns off key
array elements as PNS can sometimes only occur in certain spots
where sensitive nerves are found. Another solution Applicant has
noted that maintaining the same skin area coverage with smaller
array elements is less likely to produce PNS without sacrificing
intensity. This discovery led Applicant to create yet another
embodiment. The master slave configuration described above is used
to administer the needed the TT Field from a larger disc 1204 to
smaller ones 1206 that total the same surface area. As illustrated
in FIG. 12, Master elements 1202 control slave discs 1204, as
should be understood as explained in this and previously filed
applications between master 1202 and slave 1204 elements be
accomplished through wireless methods.
[0058] In yet another embodiment further methods are employed to
manage warming of the array elements. Fine microtubing is mounted
between the ceramic disc and the printed circuit board, with each
end of the tubing rising in a spiral fashion and then is connected
to make one continuous loop. The spiral rises above the printed
circuit board and is encapsulated in the thermal conductive potting
material. Within the microtubing is a one-way valve that only
allows fluid within the tubing to flow in one direction. As the
fluid near the disc warms, it begins to flow upwards through the
spiral cooling as it passes through the part of the spiral imbedded
in the thermal conductive potting material. If required tiny fans
can also be mounted on top of the discs to dissipate warmth.
Alternatively, microtubing can be strung throughout the system.
Instead of being in a closed loop on each disc. If tubing is strung
throughout the system from disc to disc, the fluid within the
system would be pumped through a cooling device and could be done
so from multiple locations on the array.
[0059] In all embodiments there is a need to hold the array
elements directly on the patient's skin in such a way as to not
interfere with electric field formation and to be comfortable for
the patient. Applicant has a solution 1300 to the problem as shown
in FIG. 13A. First a conductive medical adhesive 1302 (such as
Tac-Gel), is placed on the patient side of the array element 1304.
This is the insulated side from the silver layer. This is done on
all elements in the entire array 1306. The array 1306 is then
placed on the patient's skin via the applied medical adhesive 1302.
Then a specially made stretchable shirt 1310 (usually with a zipper
in the back), see FIG. 13B, is placed tightly over the arrays 1306
on the patient. Once zipped the shirt 1310 holds the arrays in
place comfortably on torso 1308 of the patient. There are air holes
through the fabric of the shirt to allow for cooling. To further
secure the arrays in place and to prevent migration during sleep.
Special clips 1312 made of material that will not interact with an
electric field are placed through the shirt and around the
connection wires/circuits between arrays.
[0060] In all embodiments the importance of preventing direct
current from touching a patient's skin is of the utmost importance.
The highest risk of a significant shock event would be if two array
elements programmed for opposite polarities failed at the same
time, allowing a breach of current to complete a circuit on, our
through the skin. Although double insulation should prevent such a
breach, Applicant has created a procedure 1400 (Refer to FIG. 14)
designed to discover any breach before therapy begins. In our
device each array element can be programed to be either active or
return. If a current breach to the skin were to occur while only
one side of a polarity is open, the resulting circuit is minute
only connecting with skin in the immediate area. The electric
current is so small it is only felt as warmth on the skin. The
present invention is able to detect even such small breaches.
Testing all array elements for possible breaches while only one
half of the polarity is open allows discovery and replacement of
any compromised array elements before they are used in conjunction
with an active and return for electric field formation. In
procedure 1400, array elements are placed on the patient at step
1402. The array elements are then programed to be energized with no
return being selected at step 1404, then array elements are
sequentially energized at step 1406 and detection of any leakage
current is undertaken at step 1408, with leakage resulting in that
element being disabled by the field generator. An LED on the
offending electrode is activated to indicate a failed unit at step
1410. The failed unit is then removed and replaced with a
functional electrode at step 1412.
[0061] It is well known that in order for tumor treating field
devices to be effective they must be worn for extended hours.
Therefore, arrays that restrict movement and cause discomfort are
not only undesirable, but can lower patient compliance to
prescribed treatment. To minimize the degree to which arrays
restrict movement, Applicant has developed a stretchable array 1500
by placing S shaped connectors 1502, 1504 between elements made of
flex circuit as illustrated in FIG. 15. For example, when an array
is placed on a person's back and they bend over or when they reach
with their right hand to their left ear the surface area of the
back expands. This causes pulling on conventional array
connections. The flex circuit connectors 1502, 1504 in the shape of
an S carry all needed wires and expand just enough to relieve
pulling on areas that could cause discomfort. A row of array
element discs connected in this way can provide 25 mm (as
illustrated at 1506) or more of extra length when in the stretched
position, increasing patient comfort.
[0062] Use of the term "array" herein has taken different meanings,
dependent upon context. In one sense when talking about the
grouping of electrodes on the body it is broadly referring to the
physical rows and columns of the electrodes, or at least their
placement, whether in rows and columns or not. The arrays that are
used in forming electromagnetic fields are dynamically selected so
that the desired field can be generated and this means a subset of
the electrodes that may or may not be adjacent are selected and
used.
[0063] While this invention has been described with respect to at
least one embodiment, the present invention can be further modified
within the spirit and scope of this disclosure. This application is
therefore intended to cover any variations, uses, or adaptations of
the invention using its general principles. Further, this
application is intended to cover such departures from the present
disclosure as come within known or customary practice in the art to
which this invention pertains and is claimed in the claims.
* * * * *