U.S. patent application number 14/605926 was filed with the patent office on 2015-05-21 for monitoring system.
The applicant listed for this patent is Thermimage, Inc.. Invention is credited to Philip Eggers, Brent W. Snow, Douglas G. Turnquist.
Application Number | 20150141864 14/605926 |
Document ID | / |
Family ID | 42667492 |
Filed Date | 2015-05-21 |
United States Patent
Application |
20150141864 |
Kind Code |
A1 |
Turnquist; Douglas G. ; et
al. |
May 21, 2015 |
Monitoring System
Abstract
A heating and monitoring system is described having a radiometer
to monitor temperature of internal tissue and or bodily fluids in a
non-invasive way. The radiometer may comprise a multi-frequency
radiometer to allow for taking a temperature reading at a desired
depth within the tissue of a patient.
Inventors: |
Turnquist; Douglas G.;
(Taylorsville, UT) ; Snow; Brent W.; (Salt Lake
City, UT) ; Eggers; Philip; (Salt Lake City,
UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Thermimage, Inc. |
Taylorsville |
UT |
US |
|
|
Family ID: |
42667492 |
Appl. No.: |
14/605926 |
Filed: |
January 26, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12713099 |
Feb 25, 2010 |
8939913 |
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14605926 |
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61156444 |
Feb 27, 2009 |
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61156441 |
Feb 27, 2009 |
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61156438 |
Feb 27, 2009 |
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61156433 |
Feb 27, 2009 |
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61156427 |
Feb 27, 2009 |
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61156407 |
Feb 27, 2009 |
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61156401 |
Feb 27, 2009 |
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61156393 |
Feb 27, 2009 |
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61156382 |
Feb 27, 2009 |
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Current U.S.
Class: |
600/549 ;
607/102 |
Current CPC
Class: |
A61B 5/201 20130101;
A61B 5/4547 20130101; A61N 5/025 20130101; A61B 5/01 20130101; A61B
18/18 20130101; A61B 2018/00791 20130101; A61B 2018/00023 20130101;
A61B 5/6887 20130101; A61G 15/10 20130101; A61B 18/1815 20130101;
A61B 5/6804 20130101; A61B 5/7282 20130101; A61B 5/6891
20130101 |
Class at
Publication: |
600/549 ;
607/102 |
International
Class: |
A61B 5/20 20060101
A61B005/20; A61B 5/00 20060101 A61B005/00; A61N 5/02 20060101
A61N005/02; A61B 5/01 20060101 A61B005/01 |
Claims
1. A detector, comprising: a focused antenna configured to
determine a condition of an internal structure; a holding mechanism
for holding the focused antenna to a surface; a radiometer coupled
to the focused antenna; an output configured to couple the
radiometer to a computer; and a shielding enclosure configured to
isolate at least the focused antenna from ambient radiation.
2. The detector of claim 1, wherein the enclosure further
comprising a shielding material.
3. The detector of claim 1, wherein the surface is the surface of
an individual and wherein the internal structure is a kidney.
4. The detector of claim 3, wherein the condition is the
temperature of urine in a kidney.
5. The detector of claim 1, wherein the internal structure is urine
in a bladder.
6. The detector of claim 5, wherein the condition is the
temperature of urine in a bladder.
7. The detector of claim 1, wherein the detector is configured to
be coupled to a chair during use.
8. The detector of claim 1, further comprising an analog to digital
converter.
9. A system comprising the detector of claim 1, and further
comprising a plurality of microwave elements for heating a
structure beyond the surface.
10. The system according to claim 9, further comprising a control
assembly configured to alternatingly activate the microwave
elements, the control assembly controlling the active microwave
heating elements at least in part in response to readings from the
focused antenna.
11. The system according to claim 9, further comprising a cooling
mechanism disposed adjacent the plurality of microwave elements for
cooling the surface.
12. A heating and monitoring system, comprising: an array of
microwave antennas, wherein the array is configured to provide a
focal area where energy emitted from each of the microwave antennas
converges; a controller configured to control the focused array of
microwave antennas; and a temperature monitoring device
13. The system of claim 12, wherein the focused array is configured
to be placed on an individual, and wherein the focal area
corresponds to the location of the bladder of the individual.
14. The system of claim 12, wherein the temperature monitoring
device is a focused antenna.
15. The system of claim 14, wherein the focused antenna is
configured to receive information correlating to the temperature of
fluid in a kidney.
16. The system of claim 14, wherein the focused antenna is
configured to receive information correlating to the temperature of
urine in a bladder.
17. The system of claim 12, wherein the temperature monitoring
device is configured to monitor the temperature of the skin located
at the interface between the individual and the focused array.
18. The system of claim 12, wherein the controller is configured to
alter the output of the array of microwave antennas based on
information provided by the temperature monitoring device.
19. The system of claim 18, wherein the controller is configured to
automatically shut-off output of the focused array if the
information provided by the temperature monitoring device indicates
a temperature above a desired threshold.
20. A system for monitoring thermal movement, the system
comprising: a heating assembly having a plurality of heat emitting
elements for generating heat at a first location below a surface; a
monitoring assembly having at least one focused antenna for
detecting temperature at a desired location below the surface; and
a control assembly in communication with the heating assembly and
the monitoring assembly for controlling the heating assembly to
apply thermal energy and for receiving information from the
monitoring assembly to determine thermal energy at the desired
location, the control assembly comprising a processor for adjusting
the heating assembly responsive to information received from the
monitoring assembly.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of copending U.S. patent
application Ser. No. 12/713,099, filed on Feb. 25, 2010 and titled
"MONITORING SYSTEM," which claims benefit and priority from U.S.
Provisional Patent Application Nos. 61/156,444, 61/156,441,
61/156,438, 61/156,433, 61/156,427, 61/156,407, 61/156,401,
61/156,393, and 61/156,382, each filed on Feb. 27, 2009. Each of
the aforementioned applications is hereby incorporated herein by
specific reference in its entirety.
FIELD
[0002] This application relates generally to noninvasive thermal
therapy and diagnostic devices and methods. More specifically, the
present invention relates to devices and methods to non-invasively
heat bodily tissues and fluid using emitted energy and
non-invasively measure the resulting temperature changes in the
target and surrounding fluid and tissue to detect and/or treat for
various physical conditions, such as, for example, vesicoureteral
reflux.
BACKGROUND
[0003] There are numerous diseases which can be treated
successfully if detected early, but which can cause long term
damage if not timely diagnosed and treated. Diseases such as
vesicoureteral reflux can cause significant harm to an individual,
but are not easily diagnosed without invasive procedures.
[0004] In vesicoureteral reflux bladder urine flows back up into
the ureters and into the kidneys. The urine can cause kidney
infections which can be painful. Moreover, repeated infections can
cause long term kidney damage. While vesicoureteral reflux can be
treated with medication or by surgical techniques, vesicoureteral
reflux is difficult to properly diagnose.
[0005] Approximately 2% of all children at any one time have a
urinary tract infection. When a child has had more than one kidney
infection, it is desirable to determine if the child has
vesicoureteral reflux. Two radiologic imaging studies are commonly
utilized: voiding cystourethogram (VCUG) and a nuclear cystogram. A
VCUG is performed in humans of all ages by first placing a sterile
catheter in the patient's urethra and through the catheter
instilling radiopaque contrast, such as Cystografin. The kidneys
and bladder are observed during a bladder filling and emptying
cycle using x-rays. The patient has an initial x-ray film taken,
then an anterior-posterior film and then films in each lateral
oblique. When voiding is initiated, fluoroscopy is utilized, and
spot films are taken to document changes during voiding. This
process has been necessary to evaluate bladder anatomy, function,
elimination and confirm the existence of vesicoureteral reflux.
After the first infection it is currently recommended that patients
undergo a VCUG and a renal imaging study. However, doctors are
sometimes reluctant to order the invasive VCUG until other
infections occur. Of the VCUGs performed, approximately one of
three patients will have vesicoureteral reflux. The reflux is
graded and treatment is assigned on the basis of severity. About
three-quarters of the patients are assigned to medical management
and are screened with a VCUG each year until their reflux resolves.
This averages about three years of waiting before resolution
occurs. Patients who undergo surgical correction of their reflux
also require a follow-up VCUG to evaluate the success of the
procedure. Patients with enuresis either at night or during the day
are evaluated with VCUGs on occasion. Since the test is currently
invasive it is withheld until the patients are older or unusual
symptoms indicate its necessity. It will be appreciated that the
VCUG procedure is uncomfortable and can be traumatic, particularly
for children.
[0006] Likewise, various other conditions exist in which body
fluids, such as urine or blood, improperly flow as a result of
disease or dysfunction. For example, gastroesophageal reflux is
common in young children. Other conditions involve disruptions in
blood flow or myocardial function resulting from narrowing of the
aorta, blood clots, or malfunction of the enterohepatic circulation
or a portion of this system, e.g. the intestine, liver or gall
bladder, or disruptions in flow of cerebrospinal fluid. Diagnosis
of such conditions has often required invasive procedures such as
use of catheters or tubes.
[0007] Besides the diseases above, body tissues are subject to
other abnormalities including cancer, scarring, inflammation and
reduced function. One potential effect of the abnormalities
includes abnormal tissue abnormally encouraging or restricting
thermal spread. Thus, the improper flow of bodily fluids may be a
condition that should be treated, or may be a symptom of a disease
in need of treatment. Either way, prompt detection of such
conditions would be beneficial.
[0008] There has been some discussion regarding administering
microwave or ultrasound energy through an external energy source to
warm a fluid in a target organ or tissue and detecting a warmed
fluid distant from the target. (See e.g. U.S. Pat. No. 7,217,245).
However, blind application of the thermal energy for a
predetermined time may cause many problems, such as mis-targeting
of the device, over or under heating of the target area, skin burns
by mis-placement of the device and/or uncomfortable or damaging
heating of the antenna itself against the patient.
[0009] There has also been discussion about a flexible microwave
antenna array on a flexible circuit board. (See e.g. U.S. Pat. No.
6,330,479). However, sensing deep tissue temperature in a
non-invasive manner can be difficult, as the emitted energy is
small.
[0010] As diseases such as vesicoureteral reflux have relied on
invasive and traumatic diagnosis procedures, a non-invasive and
less traumatic diagnosis method and equipment would be desired.
Moreover, a method for diagnosing or treating diseases with thermal
energy which does not burn or otherwise discomfort patients would
also be desirable.
SUMMARY
[0011] Embodiments of improved noninvasive heating and monitoring
devices and methods of use are disclosed below. According to some
embodiments, one or more microwave antennas are directed at a
target organ or tissue, such as the bladder. Signals broadcast by
the antenna(s) are used to heat liquid within the targeted tissue
or organ (e.g. the bladder, gall bladder, etc.). A temperature
sensing device, such as a radiometer, may be directed at the target
organ or tissue and its temperature monitored to determine the
extent to which heating has occurred at the desired location. The
temperature sensing device or a second temperature sensing device
may then be directed at a secondary location to detect an abnormal
rise (or abnormal lack of rise) in temperature. If the temperature
sensed at the secondary location is other than what would be
expected in a healthy individual, a reading can be taken which is
indicative of a disease or dysfunction. While discussed principally
in the context of urine, other body fluids such as blood, bile,
cerebrospinal fluid, lymph or other gastric fluids could also be
used to diagnose abnormal physical conditions. Similarly, the
target organ or tissue may be monitored for an abnormal dissipation
of heat as evidence of disease/dysfunction.
[0012] In some embodiments, a heating and monitoring device
includes an array of microwave elements that direct energy to a
focal point or area. These microwave elements may be controlled
separately or as a single entity. Likewise, the microwave elements
can be used simultaneously or alternatingly to obtain desired
heating characteristics.
[0013] The microwave elements may be alternately activated such
that the focal point is subject to a more consistent thermal energy
from alternating microwave elements. However, by alternating the
microwave elements, the tissue between the microwave elements and
the focal point is subject to only the energy of a single microwave
element and less frequently than the focal point. Thus the
intervening tissue may maintain a lower temperature, while the
focal point may be heated to a desired temperature. This may reduce
and hopefully eliminate discomfort or burns to the surface tissue
or intervening tissues, while providing enough energy to heat the
focal point to obtain the desired temperature.
[0014] Some embodiments of the present invention provide for a
noninvasive method for determining the condition of tissues by
administering external energy with an array device to heat a tissue
while measuring the temperature changes and heat dissipation of the
tissue and comparing to measurements of temperature changes in
normal tissues when heated. For example, in some embodiments, an
array of microwave elements may include one or more passive
elements or sensors that may be used to monitor the temperature of
the surface area of the tissue. If the tissues at the surface
approach a threshold, the sensors can signal an alarm or may alter
the application of energy from the microwave elements. This ensures
that the surface temperature does not exceed desired limits and
prevents burning or causing discomfort in the individual.
[0015] In some embodiments, temperature monitors, may be further
enabled or enhanced to enable more accurate deep tissue readings.
The device may be configured, for example, to disable the active
elements (i.e. energy applying elements such as microwave antennas)
to reduce any noise produced by the active elements. A passive
element or sensor may then take readings between application of
energy from the active elements to obtain a more accurate
temperature measurement due to a decrease in background noise or
signals.
[0016] The monitors may also be directionally shielded such that
the sensor may have increased sensitivity at the desired anatomy,
and minimized sensitivity to radiated heat from other tissues. The
increased sensitivity and decreased noise may be especially
important for deep-tissue or organ observation as the received
signal may be as small as -160 dBm.
[0017] In some embodiments, the surface area around the microwave
elements may be cooled. In some embodiments, the microwave elements
may be covered with passive cooling mechanisms such as water or gel
(i.e. a heat sink), to reduce the risk of burns caused by the
microwaves. Alternatively, active cooling mechanisms, such as a
heat pump, a heat pipe, recirculator, a refrigerated coil, etc., or
any other cooling mechanism can be used to keep tissues near the
surface cool while deeper tissues are heated.
[0018] In other embodiments, monitoring the surface temperature may
be used to control how the microwave elements are powered or which
of the array elements are active at any particular time. By
modulating the power or by selectively activating different
elements in the array, the surface temperature and the internal
energy deposition at any point may be kept low while still heating
the internal target area.
[0019] The focal area or another area may be monitored for
temperature difference after heating by a detecting mechanism such
as an antenna disposed in communication with a radiometer. Heat
dissipation from the focal area different from normal or control
tissue may indicate disease or dysfunction. Similarly, tissue or
liquid distant from the focal area may be monitored for unexpected
rise, lack of rise or decrease of temperature which may indicate
dysfunction or disease, such as vesicoureteral reflux,
gastroesophageal reflux, or a number of other diseases.
[0020] For example, one or more focused antennas disposed in
communication with one or more antennas in communication with
radiometers may be positioned on the body of an individual to
monitor the temperature change of tissue and/or fluid at a desired
depth within the body, such as for detecting fluid temperature in
the bladder or some other organ. In some embodiments, focused
antennas be placed such that a change in temperature in the kidneys
due to reflux of heated urine from the bladder may also be
monitored and thus determined non-invasively. This enables a
physician to determine that there is vesicoureteral reflux,
gastroesophageal reflux, etc., without having to use a catheter or
other invasive procedure and potentially traumatize the
individual.
[0021] Some embodiments of the present invention may include a
chair or seat configured to be used with heating and monitoring
systems that provide a secure and comfortable resting position for
an individual being diagnosed or treated. In some embodiments, the
seat may include portions of the array or monitoring devices, and
may further be shielded to prevent or reduce microwave energy from
reaching undesired areas. In some embodiments, the seat may be in
the general form of a child car seat, with restraints and other
features generally known to children. The seat may be positioned on
or next to a cabinet containing equipment for use with the system,
such as a computer and focused microwave antennas. Likewise, the
seat or seat can be configured for an adult with the heating and
monitoring systems being removably attached or built in.
[0022] In some embodiments of the invention, garments for wearing
by the individual being tested may be formed similar to a diaper or
other garment and configured to hold a heating array against the
individual and in proper position. Similarly, the garment may be
configured to work integrally with the system to provide for
comfort and safety during any procedure. For procedures involving
the bladder, the garment may be configured as a diaper (or adult
undergarment) with an absorbent layer, since testing urinary reflux
requires the individual being tested to attempt to evacuate the
bladder and urinate. In some embodiments, the garment may include
positioning aids to assist in properly positioning the garment on
the individual. The garment may also include shielding material to
reduce unwanted escape or transmission of microwave energy to
unwanted locations.
[0023] These and other aspects of the embodiments of a heating and
monitoring device are shown and described in the following figures
and related description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] Various embodiments and features of heating and monitoring
devices are shown and described in reference to the following
numbered drawings:
[0025] FIG. 1 is a schematic view of an emitted energy heating and
monitoring system;
[0026] FIG. 2 is a schematic view of an emitted energy heating and
monitoring device;
[0027] FIG. 3 is a cross sectional view of an emitted energy
heating and monitoring device in use on an individual;
[0028] FIG. 4 is a functional representation of an emitted energy
heating and monitoring system;
[0029] FIG. 5A is a functional representation of an exemplary
heating and monitoring device holder in the form of an
undergarment;
[0030] FIG. 5B is a cross sectional view of the device holder in
FIG. 5A; and
[0031] FIG. 6 is a cross-sectional view of an alternate garment
having a heating system and monitoring system formed therein.
[0032] It will be appreciated that the drawings are illustrative
and not limiting of the scope of the invention which is defined by
the appended claims. The embodiments shown accomplish various
aspects of the invention. It is appreciated that it is not possible
to clearly show each element and aspect of an invention in a single
figure, and as such, multiple figures are presented to separately
illustrate the various details of embodiments of heating and
monitoring devices in greater clarity. Several aspects from
different figures may be used in accordance with the heating and
monitoring devices in a single structure. Similarly, not every
embodiment need accomplish all advantages of various embodiments of
heating and monitoring systems.
DETAILED DESCRIPTION
[0033] Embodiments of heating and monitoring devices and associated
methods as shown in the accompanying drawings, which include
reference numerals referred to below, provide details for
understanding and practice by one skilled in the art. The drawings
and descriptions are exemplary of various aspects of heating and
monitoring systems and associated methods and are not intended to
narrow the scope of the appended claims.
[0034] Turning now specifically to FIG. 1, a schematic
representation of non-invasive energy emitting heating and
monitoring system 10 is shown. System 10 is shown being used to
diagnose a potential abnormal condition on a body 70 by applying
heat to a bladder 20 filled with urine 30 to see if the urine flows
back to the body's kidneys 60. The system 10 typically includes a
heating assembly 100, a control assembly 150, and a monitoring
assembly 160.
[0035] The heating assembly 100 typically includes microwave
elements 110, 112. As will be explained in additional detail below,
the microwave elements 110 and/or 112 can be used to heat tissue or
fluid and can be used to determine the temperature of those
tissues. The microwave elements 110 and 112 may be attached to a
substrate 120, and may also include a cooling element 143 and/or
cooling system 142 which is designed to cool tissue at or near the
surface while deeper tissue is being heated by the heating assembly
100.
[0036] Microwave elements 110 may be directional microwave
emitters, commonly known as antennas, and may be configured to
supply energy to a specific area in a body 70. For example,
microwave elements 110 may be configured to provide microwave
energy directionally into a bladder 20 filled with urine 30 so as
to heat the urine. Likewise, the microwave elements 110 can be used
to heat fluid in other body tissues.
[0037] It should be recognized that while much of the discussion
about an individual may be related to an adult human, the term
individual should be read broadly to include children and
animals.
[0038] To protect against burning or discomfort, temperature
sensors 113 may be provided in the heating assembly 100 for
detecting temperature at or near the surface of the individual's
body 70. If the sensors 113 detect excess heat, an alarm may be
provided, or the heating protocol adjusted to address the
situation. Different adjustments are discussed below in additional
detail. (It will be appreciated that the heating assembly 100 and
the monitoring assembly 160 may be a single unit in certain
applications.
[0039] As the microwave elements 110 are used to heat the target
area, it is important to monitor temperature in the target area to
prevent overheating. This can be accomplished by the heating
assembly using one or more of the microwave elements 110, 112 to
detect signals from the target area which are then passed to a
radiometer 180a which indicates the temperature in the target area.
While it is possible to use active microwave elements 110 after
they have been turned off, it is presently preferred to use passive
microwave element 112 to detect the temperature in conjunction with
the radiometer 180a.
[0040] Likewise, in certain applications, temperature sensors (e.g.
focused antennas) in the monitoring assembly 160 can be used to
detect temperature of the target location being heated and/or to
detect the temperature in a remote locations, such as the kidneys
60, to ensure that excess heat is not provided, and to gather data
used to diagnose an abnormal condition. Thus, for example, focused
antenna(s) 162 in the monitoring assembly 160 may collect signals
and communicate with one or more radiometers 180b to indicate the
temperature at or adjacent kidneys 60.
[0041] A control assembly 150 may monitor the system 10 for safety,
record the observed results and display the results to the system
10 operator. Thus, the operator may simultaneously monitor the
application of heat to (or creation of heat within) one part of the
body 70 and detect changes in heat at a second location.
[0042] In the heating assembly 100, microwave elements 110 may be
placed in an array, and may be arranged and/or spaced apart from
each other in the array such that microwave elements 110 provide
for a convergence point or area, such that focal area 116 may be
affected by the aggregate energy of each of microwave elements 110.
Since each of microwave elements 110 may be directional, the energy
emitted by microwave elements 110 may travel through body 70 in a
generally columnar application. Microwave elements 110 may be
arranged in an array in such a way that the convergence of each of
microwave elements 110 occurs principally or entirely in the
interior space of bladder 20, heating urine 30. This may be
accomplished by placing the microwave elements 110 on a flexible
substrate 120 or by use of a rigid substrate which can have
connections (i.e. pivot attachments) which allow the microwave
elements 110 to be angled to adjust for the depth of the target.
(For example, a bladder on an overweight adult will be much deeper
than a bladder on a thin child). Alternatively, the heating
assembly 100 could be preconfigured for various depths of target
tissue, with the physician selecting the assembly which is most
appropriate for a particular individual.
[0043] In some embodiments, anatomy may be consistent enough to
allow a holder to naturally direct microwave elements to the target
tissue based on placement on the skin. In one embodiment, the
physician selects a heating assembly that conforms to the surface
of the individual. When placed on the skin using the individual's
anatomy as a guide, the microwave elements naturally focus to a
target tissue. The holder may include pivot attachments that may
have markings that allow the microwave elements to be adjusted
based on specific characteristics of the individual such as height,
weight, and/or girth.
[0044] Generally, each of the columnar energy emissions heats all
tissue or fluids within the columnar area. Thus, focal area 116
will receive an aggregate of the combined energies of the
overlapping columnar energy emission areas for that area,
increasing the energy absorption and subsequent heating of urine 30
within bladder 20. With four microwave elements 110 as shown in the
embodiment illustrated in FIG. 2, the amount of energy applied to
the surface of body 70 and other tissues and fluids outside of the
targeted focal area 116 may be reduced from that of a single
microwave element 110, spreading out the energy over a larger
surface area and volume of tissue while not diminishing the energy
absorbed in focal area 116. For example, in an array with four
microwave elements 110, the skin of body 70 located directly under
microwave element 110 will typically receive less energy than would
have been required to heat urine 30 with only a single microwave
element 110.
[0045] In some embodiments, microwave elements 110 may be designed
such that each microwave element 110 emits a generally columnar
energy emission. In some embodiments, the dimensions of the
columnar energy emission may be selected to maximize the profile of
focal area 116 while minimizing excess heating of surrounding
tissues. The columnar shape or lobes of the radiated energy may be
of any configuration desired by a practitioner to provide energy to
a focal area 116.
[0046] The energy from microwave elements 110 may be additive when
supplied to and absorbed by focal area 116. For example, the energy
from each of the overlapping focal planes contributes to the energy
received by the focal area 116. Adjusting the overlapping focal
planes may maximize the energy applied to focal area 116, while
minimizing the energy applied to tissues outside of focal area 116.
Based on the geometry of the array of microwave elements 110 on
heating assembly 100, the energy emitted from the array may be
further maximized by adjusting transmission times, direction,
frequency, and amplitude of the energy emitted.
[0047] For example, in some applications a first microwave element
110 could emit a high energy emission for a few seconds and then
cease. The microwave element 112 could quickly monitor the
temperature of the bladder 20 and then a second microwave element
could emit a high energy emission for a few seconds, followed by
additional monitoring of the temperature of the bladder 20. The
process is repeated until the bladder has reached a desired
temperature. However, the tissue between the bladder and any given
microwave element 110 would heat much less than if a single heating
element were used. Moreover, blood passing through non-target
tissues would tend to conduct heat away from said tissues, while
the liquid in the bladder would tend to retain the heat. Between
alternating application of energy and the conductive cooling, the
heating in the bladder will be significantly greater than the other
tissues.
[0048] In other applications, each of the microwave elements 110
(whether it be four or a different number) could be activated in
sequence and then the microwave element 112 and radiometer 180a
used to check the temperature of the target. By applying energy
from multiple locations, the heating of tissue other than the
target tissue is reduced, lessening the likelihood of burns or
discomfort.
[0049] Providing a plurality of different application protocols is
desirable because different tissues or other intervening structures
have different reactions to microwave energy. According to our
experience, tissues with higher salt content will absorb more
microwave energy than lower salt content tissues. The bladder and
muscle tissue have been observed to absorb more energy than fat
tissue. Vascular tissues, such as muscle tissue, appear to cool
faster than non-vascular tissue or static liquids, such as the
bladder.
[0050] Taking advantage of this experience, the microwave elements
110 may be activated in different ways depending on factors such as
intervening tissue and focal area. For example, when the
intervening tissue and structures may be vascular and/or less
responsive to microwave energy, a higher power, multiple element
simultaneous activation and/or longer duration may be used because
of the ability of the tissue to cool and/or absorb less energy.
Similarly, if the focal area 116 is within a static liquid with a
higher salt content, a higher power, multiple element simultaneous
activation and/or longer duration may be used due to the likely
better heating of the tissue and/or structure.
[0051] In other situations it may be advantageous to use lower
power, alternating microwave element activation and/or shorter
duration. In some cases, it may be advantageous to mix the
activation, duration and power settings. For example, in one
embodiment, when heating urine, multiple microwave elements may be
activated for a short duration with longer periods for conductive
cooling.
[0052] For example, in one embodiment with four antennas numbered
A, B, C and D, the process of heating urine may be the following.
Antennas A and C are activated for a short time at high power. The
antennas are de-activated and the radiometer readings are examined.
If a higher temperature is desired, antennas B and D are activated
for a short time at moderate power or high power depending on the
sensed temperature. The radiometer readings are then consulted
again. If more power is desired, then the process repeats with A
and C again.
[0053] The process allows the intervening tissue of A and C to cool
during the radiometer readings and B and D's activation.
Furthermore, it aids in preventing noise during the temperature
reading from the passive element 112 and radiometer 180a, as the
radiometer may be detecting a small signal that may be on the order
of -160 dBm.
[0054] In some embodiments, the attitude of each microwave elements
110 relative to each other may be fixed such that the location of
the focal area is known based on the physical configuration of
heating assembly 100. Similarly, in some embodiments, substrate 120
may be rigid to provide structure to allow fixed relative
positioning of microwave elements 110. In other embodiments, rigid
microwave elements may be placed on a flexible structure that is
carefully placed and may be adhered to the individual. The
placement on the body acts as the fixed relative positioning of the
microwave elements.
[0055] Microwave element 112 may be a passive antenna for
monitoring temperatures of portions of body 70. For example,
microwave element 112 may be a passive element for measuring the
condition, including temperature, specific heat, rate of heat
dissipation, etc., of the focus point or focal area. In some
embodiments, microwave elements 110 may be used to both emit
microwave energy when active, and passively to monitor conditions
of tissue, such as temperature, when not emitting energy (although
such would be more difficult than using a passive element for such
monitoring). In such embodiments, microwave element 112 may not be
necessary. Similarly, m some embodiments, microwave element 112 may
be replaced with a focused antenna similar to those in the
monitoring system 160 which are in communication with radiometer
180b.
[0056] However, in deeper tissue sensing, it may be more
advantageous to have a dedicated sensing antenna as the passive
antenna. For example, the temperature signal strength from heated
urine may be as small as -160 dBm. Thus, increasing the signal to
noise ratio may be advantageous.
[0057] Noise may be reduced by methods including shielding and
reducing active interference. The passive antenna/element 112 may
be provided with a shield 115 so that detection only occurs in the
direction of a target area of the body. Any cable connections
between the antenna/element 112 and the receiver, such as
radiometer 180a, may be shielded to reduce noise. Active microwave
elements 110 may be shielded (i.e. shield 117, FIG. 3) to provide
directionality to the focal area while reducing or eliminating
other directionality. Active interference may be reduced by causing
the active microwave elements 110 to cease transmitting during a
window of time that sensing may occur (a.k.a. a sensing window).
Further active interference may be reduced by causing portions of
the control equipment to shut down during a sensing window. In some
cases, it may be advantageous to combine the radiometer 180a and
passive antenna/element 112 into a single unit that may be placed
on the individual. Such a unit may contain one or more of the
following a focused antenna, radiometer, output to a computer, a
shielding enclosure and an analog to digital converter.
[0058] Impedance matching of the radiometer 180a to the body may
also be important in signal quality. The impedance may be matched
through the fixture 121 (FIG. 3) (i.e. strap or other retention
mechanism) to which the antenna is attached. For example, the
fixture 121 may use a foam pad to not only conform to the skin's
shape, but also impedance match the radiometer to the body. One or
more of the passive antenna fixtures may be different than the
microwave antenna array fixture, as they may be directed at
different anatomy.
[0059] In some embodiments, temperature sensors 132 may be used to
monitor the surface temperature of body 70 in specific locations,
or may be used to monitor the temperature of a cooling system 142.
For example, in some embodiments temperature sensors 132 may be
placed adjacent to each microwave element 110, as well as in other
areas, to monitor surface temperatures of body 70, and in
cooperation with control assembly 150, to reduce the possibility of
tissue damage or surface burns. Temperature sensors 132 may be any
type of temperature sensor configurable to send electronic signals,
such as thermistors, thermocouples, or any other suitable
devices.
[0060] Control assembly 150 may include PC 152 (or other
microcontroller, control system, etc.), heating control 156,
amplifier 158 and multiplexer 114 (for controlling heating assembly
100), cooling system controller 142, and radiometers 180a and 180b.
I/O devices 154 may be provided for user interaction and input with
system 10. Heating control 156, amplifier 158, and multiplexer 114
may be used, along with PC 152, to control the output of microwave
elements 110.
[0061] In some embodiments, microwave elements 110 may be activated
and de-activated in a pattern or sequence to limit potential damage
to body 70, while obtaining the desired heating of an internal
organ or tissue. Microwave elements 110 may be activated and
de-activated simultaneously, or may be selectively activated and
de-activated individually and/or concurrently with one or more
other microwave elements 110 in a pattern. The power, duration, and
sequence of activation of microwave elements may be controlled by
heating control 156. The control may further be refined based on
measured surface temperatures of body 70, temperatures of cooling
element 143, or based on any other desired input or parameter such
as a pre-determined energy output profiles or individual physiology
and anatomy. Thus, heating control may depend on such factors as
body fat content, bladder size/fullness and the size of the
individual.
[0062] For example, when heating urine, multiple microwave elements
may be activated simultaneously for a short duration at a desired
energy level (low, medium or high) followed by an inactive
refractory period. Blood flow from vascular tissues, such as
muscle, rid the intervening tissue of excess heat. Since the
bladder does not have a similar blood flow, the urine will stay
heated.
[0063] In some embodiments, amplifier 158 may provide microwave
energy to microwave elements 110 through multiplexor 114 or from
individual amplifiers. Preferably, the energy is in the microwave
ISM bands, with a preferred frequency range of 902 MHz to 928 MHz
with a preferred frequency of 915 MHz. However, other models
outside the U.S. may need to use alternate ISM bands. Therefore a
frequency range of 863 MHz to 870 MHz may also be desirable in
other countries, such as those in Europe. The microwave energy
supplied by amplifier 158 may be about 100 W at about 915 MHz. Each
of microwave emitters 110 may be capable of emitting the entire
output of amplifier 158, or some portion thereof.
[0064] In contrast, the energy received by a sensor such as the
radiometer 180a or 180b may be between about 1-4 GHz. In fact, the
energy emitted by the body 70 is believed to correspond to an
integral of the heat of all the tissue to the detected depth. The
detected depth is believed to depend on the frequency selected.
Thus a measurement at two different frequencies may correspond to a
heated volume. The heated volume may then correspond to a
temperature at the heated volume. Thus, a multi-frequency
radiometer or two or more radiometers may be used to detect and/or
quantify temperature at a depth in a non-invasive way by comparing
first and second energy levels. Another benefit of multi-frequency
radiometers is that depth may be adjusted on a per individual
basis. In some embodiments, the frequency emitted may more
particularly be between about 1.2-1.4 GHz.
[0065] These results may then be compared to an actual, normalized
or expected energy level. The normalization may be based on
anatomical data. In one embodiment, the examined depth may be
between 2 cm and 7 cm. In one embodiment, the measured levels are
presented by an image. The image may be based on actual values or
calculated values, such as a delta between actual and expected
values. In some cases, quantifying the data may require integration
to determine an aggregate of energy change.
[0066] In some embodiments a target of total energy supplied by
system 10 to body 70 may be about 5 W to 60 W over about 5-20 min.
The amount of energy emitted should be sufficient to heat the
targeted body portion to a desired temperature, such as raising the
temperature of urine 30 a measurable amount over body temperature.
The target temperature may be sufficient such that the heated urine
may be detected in the kidneys during a reflux event, but not so
hot as to damage tissues or cause significant discomfort. Heating
assembly 110 may be connected to control assembly through connector
114.
[0067] In some embodiments, cooling system 142, along with cooling
element 143, may be used to cool the surface of body 70 at or near
where heating assembly 100 supplies energy to body 70. In one
embodiment, cooling system 142 may circulate and monitor cooling
fluid through cooling element 143. The cooling system 142 may also
alternatively actively remove heat from the area using a heat sink,
heat pump, heat pipe, or other similar devices alone or in
combination, as represented by cooling element 143. Cooling system
142 may provide signals to heating controller 156 indicating the
temperature and status of the cooling system and/or surface of body
70, such that the system may maintain a safe operation. In one
embodiment, the cooling system is controlled based on signals from
the controller.
[0068] In some embodiments, system 10 may not have cooling system
142, but only cooling element 143. Cooling element 143 may be a
cooling gel, water, or other cooling medium or device. In some
embodiments, cooling element 143 may be configured to be replaced
intermittently as cooling element 143 is heated by energy emitted
from microwave elements 110. In some embodiments, cooling element
143 may be fixedly coupled to substrate 120. Cooling element 143
may be configured to circulate a cooling medium, such as water, or
may house, or be formed from a cooling medium, such as a cooling
gel.
[0069] In one embodiment, a heat sink and heat pipe structure
(collectively 143) is embedded in a flexible and disposable
fixture. The heat sink collects heat from the body surface and/or
the microwave antenna elements. The heat pipe then wicks away the
heat from the heat sink. The heat sink and/or heat pipe may have
internal temperature sensors to report the current temperature of
the system. If used in conjunction with temperature sensors on the
skin, the system may be able to determine the effectiveness of the
cooling system. Effectiveness of the cooling system may also be a
lead indicator of blockages or stoppages of active or passive
portions of the system. These problems may include heat sink fin
buildup, clogged heat pipes, or lack of sufficient cooling medium
(air or water).
[0070] Monitoring assembly 160 may include one or more focused
antenna 162. Each of focused antennas 162 may have a corresponding
signal conditioners including pre-amps 164 and filters and
positioner 166. Monitoring assembly 160 may have shielding 167 to
shield the focused antennas 162 from the control assembly 150. The
shielding may be required to avoid interference and to allow proper
calibration and detection by each focused antenna 162. The
shielding 167 may be a fabric, mesh, or any other suitable
material. Important shielding may include conductive shielding from
the active antennas and the individual's skin, thus preventing
potentially substantial causes of ambient noise. The shielding 167
may be constructed as part of a disposable fixture, through
materials such as conductive foam.
[0071] Focused antenna 162 may be positioned to detect changes of
temperatures in the body, such as kidneys 60. In some embodiments,
multiple antennas 162 may be used to detect temperatures in various
locations in each kidney 60, or of each kidney 60, independent of
each other. Monitoring assembly 160 may be connected to control
assembly 150 by connector 168. Similarly, a focused antenna 162 may
be used to monitor the temperature of urine 30 in bladder 20, and
may be positioned with, or may be incorporated into heating
assembly 100. In some embodiments, the desired depth of measurement
within the tissue may be adjusted based on physiological and
biometric data, as well as frequency and intensity adjustments.
[0072] The frequency may be adjusted based on several different
factors. The adjustment may be normalized on typical anatomy
measurements. In some embodiments, the adjustment is based on
inferred or measured data from other imaging data, such as an
ultrasound, MRI, or from prior baseline measurements. In other
embodiments, the entire area may be imaged by varying the sensor's
detected frequency range.
[0073] Radiometer 180b may be provided in control assembly 150, or
in monitoring assembly 160, to receive input from focused antennas
162 and provide coherent data to PC 152 corresponding to the input
from focused antennas 162. In some embodiments, radiometer may be
located in monitoring assembly 160, within the shielding of
monitoring assembly 160.
[0074] Positioner 166 may be configured to work in conjunction with
a fixture of focused antenna 162 to allow a practitioner to direct
the focused antenna 162 to detect temperature in a desired location
within body 70. A practitioner may locate one or more anatomical
features to facilitate desired positioning of focused antenna 162
over tissue, internal body portions and/or fluids at a depth to be
monitored, such as a bladder with urine, or a kidney. In some
embodiments, a focused antenna may be placed to detect both the
temperature of urine in a bladder, and a second focused antenna may
be placed to detect the temperature of fluids in a kidney. In some
embodiments, the anatomical feature may be detected using
ultrasound to ensure proper placement of focused antenna 162.
Positioner 166 may then be used to hold focused antenna in place,
and may be adjusted as desired. The described methods of
positioning of focused antenna 162 may also be used to position
heating assembly 100.
[0075] Steps to use the device may include: Locating an anatomical
feature associated with a first desired internal body portion;
positioning a first device based on the locating the anatomical
feature, wherein the first device is configured to alter a
condition of the first internal body portion; positioning a second
device on the individual, wherein the second device is configured
to monitor the condition of a second internal body portion; and
applying microwave energy from the first device to the individual,
the energy being configured to increase the temperature of the
first internal body portion without injuring the individual.
Optional steps may include: further comprising monitoring the
condition of the second internal body portion; further comprising
locating a second anatomical feature associated with the second
desired internal body portion, wherein the positioning the second
device is based on the locating an anatomical features associated
with the second desired internal body portion; or using an
ultrasound device to locate the anatomical feature.
[0076] In some embodiments, positioner 166 may be coupled to a seat
200, such as is shown in FIG. 4, in an area located proximate to
the portion of an individual 205 to be monitored. Positioners 166
may provide for multi-axis positioning of focused antenna 162, to
allow a practitioner maximum allowance to properly position focused
antenna 162 with respect to a targeted point or region, such as a
desired portion of a kidney. For example, positioners 166 may be
coupled to seat 200 such that the attachment allows for adjustment
laterally, vertically, and axially of focused antenna 162.
[0077] In some embodiments, positioner 166 may be disposable. For
example, a disposable contact member with positioners 166 may be
provided to directly contact body 70, allowing monitoring assembly
160 to be attached in the appropriate location relative to body 70,
while allowing for the disposable contact member to be thrown away
after each use, or when soiled by an individual being treated with
system 10. For example, positioner 166 may include an adhesive
portion for temporarily affixing positioner 166 to an individual
being treated.
[0078] In some embodiments, positioner 166 may include an impedance
matching element 169 placed between focused antenna 162 and the
individual being treated. The impedance matching element 169 may be
selected based on measured biological data from the individual to
allow focused antenna to be tuned for each individual being
treated. The impedance matching element may be formed from plastic,
or other suitable material, and may be physically designed to
provide a desired impedance matching effect, such as thickness,
density, etc. In some embodiments, the impedance matching element
may be formed such that it may be affixed to the individual being
treated or diagnosed and may be used as a positioning aid to help
place focused antenna 162 in correct position relative to the
physiology of the individual being treated.
[0079] In another embodiment, a fixture 121 may be adhesively
applied to the body 70. With reasonable placement, normal contours
of the body may direct the focused antenna 162 to the correct
anatomic regions. Conductive foam 169 (i.e. an impedance matching
element) may be used around the focused antenna 162 to shield the
focused antenna 162 from noise. A dielectric foam may be applied
between the antenna and the body to aid in a predictable electrical
pathway to the desired target area.
[0080] The fixture 121 (FIG. 3) may be configured with a receptacle
171 to accept and release the focused antenna 162 or an assembly
containing the focused antenna, such as a combination of antenna
and radiometer. Likewise the fixture 121 may have receptacle 171
for the passive antenna 112 (which can function as a focused
antenna). As the antenna and/or assembly may be expensive, reuse of
the assembly may be cost effective. Thus, the disposable portion of
the fixture 121 may include the receptacle that directs the focused
antenna 162 or passive antenna 112 to the proper target area, while
providing shielding.
[0081] The rate and magnitude of thermal change may be compared to
expected data. The differences may indicate a disease and/or
diagnosis as well as a measurement of severity. Further, the data
may indicate or provide a factor of indication in the amount and
duration of fluid migration between bladder and kidney. Thus with
normalized data, the system may include a temperature trigger that
may automate a portion of the diagnosis and/or determination of
severity.
[0082] Measurements by the system of thermal changes may be
converted to graphs or other visualizations of the measured data
set, including color real-time manipulable 3 dimensional images.
The visualizations may grant an operator a quicker understanding of
the data. As discussed above, the image data may be based in the
integral of the temperature in the direction of the temperature
sensor (such as a radiometer). More resolution may be obtained by
overlapping sensor detection areas, especially with a different
direction. In fact, the image may aid the operator's use and
diagnosis in real-time. In some embodiments, the image may be
displayed on I/O device 154, as I/O device 154 may be one or more
of a monitor, touch screen monitor, or other data entry device
keyboard, mouse, or any other I/O device desirable for use with
system 10.
[0083] In some embodiments, heating controller 156 may be used to
control a safety turn-off based on temperatures monitored in or on
body 70. Algorithms may be used to limit energy output based on the
size and age of the individual, inflated size of the bladder,
thickness of muscle and intervening tissue, temperature sensors in
the cooling apparatus, any temperature sensors in the bladder and
temperature sensors on the skin. For example, if input from
temperature sensors 132, passive microwave element 112, focused
antennas 162, or other input indicates the possibility or
likelihood of injury to body 70 or an anomalous reading, heating
controller 156 may shut down the procedure to avoid injury to body
70. Similarly, temperature inputs may be constantly monitored and
the output at microwave elements 110 adjusted accordingly to
optimize the heating rate and avoid injury or unwanted tissue
damage according to anatomy. Such adjustment, safety shut-down and
monitoring, may be done automatically by control assembly 150.
Adjustments may include: selectively cycling which portion of the
focused array emits energy; altering the duration of time the
focused array emits energy; altering the period at which at least a
portion of the focused array emits energy tuning off the focused
array, etc., such that an optimum energy may be emitted without
damaging tissue.
[0084] In one embodiment, the heating assembly 100 and the
monitoring assembly 160 may be wirelessly coupled to the control
assembly 150. The wireless coupling may allow the individual more
comfort and/or freedom of movement. In some procedures, the
individual may be required to urinate the heated liquid. With
wireless coupling, the individual may be able to use a normal
restroom while being diagnosed.
[0085] With remote monitoring, the system may require more hardware
that is respectful of the equipment. For instance, the wireless
communication may need to cease during the detection phase of a
radiometer to reduce interference. Thus, the system may need local
storage to store and forward the results after the measurements.
Procedures may also have different power requirements. Thus a lower
power procedure may use a small portable power supply, such as a
battery or fuel cell, that may strap on the individual. Higher
power procedures may require a power supply that is separately
wheeled by the individual or an attendant.
[0086] Turning now to FIG. 2, a schematic view of an emitted energy
heating and monitoring device is shown. The array may have two or
more of microwave elements 110. FIG. 2 illustrates four microwave
elements 110. It will be appreciated that as many microwave
elements 110 as desired may be used in the array on heating
assembly 100. In some embodiments, microwave elements 110 may be
lobes of a single microwave antenna, generating separate energy
emissions from each lobe such that the lobes work in a manner
similar to distinct microwave elements 110 as described below.
[0087] The heating assembly may include rigid microwave elements
110 on a flexible, disposable fixture 121 such as a band, strap or
other retention mechanism. The fixture 121 may contain or use a
layer, such as a dielectric foam, allowing the microwave antenna a
more predictable electrical pathway to the focal area. The system
may also be shielded to prevent the scattering of microwaves to the
back or side of the assembly. This shielding may be accomplished
through a backplane, more conductive foam or other shielding
methods.
[0088] Turning now to FIG. 3, a cross sectional view of an emitted
energy heating and monitoring device 100a in use on an individual
is shown. Individual microwave antennas 110 may be directed to a
focal area 116, such as urine in an individual's bladder. A cooling
element 143 may be used to reduce the temperature of the skin as
raised by the microwave antennas. A passive antenna 112 (or focused
antenna) may be used to monitor the temperature at the focal area
116 and/or a target area for diagnosis.
[0089] Thus, the heating and monitoring device 100a, may form the
heating assembly 100 and be used in conjunction with the monitoring
assembly 160, or may be used for both functions in appropriate
circumstances, i.e. determining temperature change in a relatively
small area.
[0090] Turning now to FIG. 4, a seat 200 may be provided on a
cabinet or base 151 housing a control system 150. Similarly,
monitoring system 160 may be directly coupled to seat 200. Heating
assembly 100 may be provided as a portion of seat 200, or as a
device configured to be coupled to seat 200. For example, seat 200
may be similar to a car seat familiar to a child, or may be a
full-sized seat configured for receiving an adult. In some
embodiments, chair or seat 200 may include a formed portion and a
soft portion covering part of the formed portion to provide a
comfortable seating surface for individual 205. In some
embodiments, seat 200 or portion thereof, may be formed or molded
from a microwave resistant plastic.
[0091] Heating assembly 100 may be coupled to a restraint portion
210, such as a lap belt, chest belt, restraint arm or other
structure configured to be positioned across a portion of the
individual 205. The heating assembly 100 and the monitoring system
160 may be fixedly attached to the seat, or may be removable, to
allow for different configurations depending on the particular
anatomy of the individual which is the focus of testing. For
example, the monitoring assembly may be slidable along the seat due
to a plurality of slots, etc. so as to accommodate different sized
individuals.
[0092] In another embodiment, all or part of the heating assembly
100 is separate from the seat 200 and restraint portion or lap band
210 and may even be disposable. Restraint portion 210 may include
fasteners 212 and 214, including a latch and latch receiver, for
releasably securing restraint portion 210 to seat 200. In some
embodiments, positioners 166 may be positioned to provide contact
between focused antennas 162 and individual 205.
[0093] Monitoring assembly 160 may be removably, or permanently
coupled to seat 200. Shielding of monitoring assembly 160 may be
incorporated into seat 200 and into restraint portion 210, where a
shielded focused antenna similar to those in monitoring assembly
160 may be used. An impedance matching foam may be attached to the
seat such that it forms an impedance matching layer between the
monitoring assembly and the individual. The foam may also be made
disposable, such that the foam may be thrown away, resulting in a
reduced cost of sanitizing the seat and sensors.
[0094] It will be appreciated that the relative position of the
heating and monitoring assemblies 100 and 160 will depend on the
structures to be heated and monitored. Thus, it is conceivable that
for certain diagnostic procedures, the heating assembly may be
attached to the seat 200 and the monitoring assembly may be held to
the individual by a lap band, shoulder band, etc. Thus, the
shielding and movability of the heating assembly 100 and monitoring
assembly 160 may be reversed.
[0095] In one embodiment, the seat may be coupled with an
entertainment system. Thus the individual may be entertained and
relax while a procedure as described in this disclosure is
performed. The entertainment system may include sound and/or video
equipment. In one situation, the equipment may also contain a
two-way communications system, such that the individual may page or
otherwise get the attention of health care staff or the staff may
converse with the individual from a distance.
[0096] FIGS. 5A and 5B show an alternate configuration of the
present invention in which heating assembly 100 may be provided in
holder such as a garment 300, which may be a disposable diaper for
an infant or an undergarment for wearing by an adult. In other
embodiments, heating assembly 100 may be readily attachable to a
disposable diaper, or may be otherwise provided in a package
comfortable for an individual.
[0097] In some embodiments, portions of heating assembly 100 may be
included in a disposable diaper, with others may be included in a
restraint portion of seat 200 similar to that shown in FIG. 4. In
some embodiments, seat 200 and other accompanying elements may be
constructed to resist the microwave energy and to limit or
eliminate unwanted microwave energy from being transmitted to the
area around seat 200 or system 10.
[0098] Garment 300 may include coupling portion 310 with an
interface, such as a pocket, which may allow for attaching at least
a portion of heating assembly 100 to garment 300. In some
embodiments, garment 300 may include open area 312 to allow heating
assembly 100 to contact the individual directly. Garment 300 may
also include securement portion 330 for attaching garment 300 to
the individual. For example, securement portion 330 may be tabs
that secure portions of garment 300 to itself. Securement portion
330 may be adjustable to allow garment 300 to be adjusted to allow
heating assembly 100 to be located properly on the individual
depending on the individual's size. Garment 300 may include
absorbent material 320, similar to a standard diaper or
incontinence undergarment. Since reflux generally occurs when an
individual attempts to urinate, having a disposable absorbent
material 320 like in a diaper helps to facilitate comfort during
procedures. In some embodiments, garment 300 may also include
cooling element 143, either integrally formed in garment 300, or
attached or otherwise inserted into garment 300. In some
embodiments, garment 300 may be disposable, with portions of
heating assembly 100 manufactured into garments 300, and disposable
after each use. In some embodiments, garments 300 may include
access 314 for a focused antenna 112, as discussed above, for
separate installation. Similarly, in some embodiments, portions of
garment 300, such as absorbent material 320 may include shielding
materials to help improve the sensitivity of the various monitoring
devices in system 10.
[0099] Turning now to FIG. 6, there is shown an alternate
embodiment of a holder or garment 350 in accordance with the
principles of the present invention. The garment 350 may be worn by
an individual. The garment 350 has the heating assembly 100 and the
monitoring assembly 160 attached thereto. All or part of the
heating assembly 100 and/or the monitoring assembly 160 may be
discarded with the garment 350. However, due to the cost of the
focused antennas and radiometer assemblies, it is presently
preferred to have at least those structures be removeably attached
to the garment 350 for reuse with further procedures.
[0100] Although system 10 has been described with microwave
elements 110, other heating methods may be provided and used with
other portions of system 10. Similarly, the components of system 10
may be provided in any number of configurations, and not
necessarily in the particular configurations and locations
illustrated in the Figures. For example, multiplexor 114 may be
located on substrate 120 of heating assembly 100, or PC 152 may be
remote from the rest of system 10, being connected wirelessly to
other components of system 10. Other configurations and uses,
either individually or with one or more other components taught in
the Figures, are contemplated by this application.
[0101] While the present invention has been discussed primarily
with respect to vesicoureteral reflux, there are numerous other
scenarios in which the principles of the present invention could be
used. For example, systems and methods in accordance with the
present invention can be used regarding the nervous system.
[0102] There is not a current imaging method that adequately shows
flow of the cerebral spinal fluid through the aqueducts to and from
the spinal column. Current studies simply show dilatation of
obstructed chambers. Warming either the spine or the head and
measuring the temperature in the opposite end (or some other
location) of the nervous system would easily show the migration of
the warm cerebral spinal fluid through its proper ductal network.
This flow could be timed to know how rapid this occurs and whether
any abnormalities exist.
[0103] Likewise, the present invention could be used in the dental
field. Applications for the system and methods of the present
invention may be as simple as having the patient drink a warm drink
or a cold drink and measuring how rapidly the teeth returns a
normal temperature, indicating good blood flow and viability of the
teeth. Sensitivity to hot or cold is a common problem and difficult
to determine exactly which tooth is causing the problem. The
systems and methods of the present invention, with their ability to
determine actual temperatures may be very helpful in determining
the underlying condition.
[0104] Likewise, the present invention could be used in the
pulmonary field. Anticipated benefits for imaging the pulmonary
tree may be significant. Currently there are few diagnostic studies
to determine ventilatory patterns deep within the bronchial tree
and the alveoli. The patient could be asked to breathe warm or cold
air and the systems and methods of the present invention could
measure temperature changes throughout the lung fields, determining
which areas were easily ventilated and watching their return to
normal.
[0105] The systems and methods of the present invention could be
used as a way to watch the lung disease processes resolve. Once a
patient has breathed warm or cold air, the systems and methods of
the present invention should be able to observe the normal blood
vessels that don't change with the ventilation temperature to
determine perfusion in the lungs and ought to be an alternative
method to evaluate ventilation and perfusion defects.
[0106] The systems and methods of the present invention could also
be used in the cardiovascular context. For example, an individual
could have the heart warmed and then measurements of peripheral
blood flow to any of the following arteries: carotid artery,
femoral artery, brachial artery descending aorta, etc. The systems
and methods of the present invention could be used to measure
peripheral vascular blood flow. Knowing how rapidly the heart was
warmed a mathematical calculation of cardiac output could be
performed.
[0107] As the resolution of the systems and methods of the present
invention improves, it may be possible that the coronary vessels
could be seen distinctly from the heart chambers themselves,
allowing imaging that is currently only available by intravascular
catheterizations. Conversely, if a peripheral area, such as a
femoral area was warm, we could watch and calculate venous return
to the heart, including cardiac output.
[0108] The systems and methods of the present invention could be
used if the lung fields were warmed, either the right side or the
left side, or both sides at once, to observe the vascular tree of
the lungs, both pulmonary artery and pulmonary venous systems could
be well-delineated.
[0109] If an IV was in place an injection of cold bolus of fluid of
known amount could be injected and the systems and methods of the
present invention could be used to measure the temperature and with
thermodilution calculations the cardiac output could be determined
accurately.
[0110] The systems and methods of the present invention could be
used in the genitourinary system (besides vesicoureteral reflux).
For example, if the kidney were warm, the urine flowing to the
bladder could be seen and measured alleviating the need for an
intravenous pyelogram (IVP) and at much diminished expense from a
CT scan. Warmed bladder urine could be observed during the voiding
process and perhaps eliminate the need for voiding
cystoureterograms in non-refluxing patients.
[0111] On occasions renal cysts are difficult to delineate from a
diverticula of the collecting system, which does have a
communication with the collecting system. If the fluid pocket was
warm and the temperature changes, one could tell it was a
diverticulum with the communication to the kidney and if the
temperature simply diffused through the kidney, one would know this
is a cyst without fluid communication.
[0112] Regarding, GI imaging, swallowing warm or cold fluid could
be used in conjunction with the systems and methods of the present
invention, as the temperature monitoring devices may be used to
evaluate esophagus transit and stomach transit times. If the
stomach were warm, observation of the esophagus would determine
whether there was gastroesophageal reflux. If the stomach were
warmed or if warm or cold fluids were swallowed, the intestinal
transit time may be calculateable with the systems and methods of
the present invention.
[0113] Likewise, the traditional barium enema to study the large
intestine may still require and catheter and fluid to be placed,
but the temperature of the fluid could be adjusted so that the
systems and methods of the present invention could be the imaging
modality of choice so that no ionizing radiation is required.
[0114] Similarly, the flow of bile from the gallbladder, through
the bile duct could be imaged by warming the gallbladder and
watching the warm bile go down the duct into the duodenum. The
systems and methods of the present invention could render such
monitoring relatively easy and noninvasive.
[0115] In obstetrics and gynecology, the hysterosalpingogram study
to determine patency of the fallopian tubes could be done with a
cold solution and imaged with the systems and methods of the
present invention so that no ionizing radiation would be necessary,
especially in the area of the gonads, which can be damaging.
[0116] Likewise, during pregnancy, the amniotic fluid could be
warmed and the turn over time of the amniotic fluid could be
measured, fetal swallowing could be observed and fetal urination
would be visible.
[0117] In orthopedics, joint spaces have fluid and the fluid could
be warmed and observed for even distribution throughout the joint
space. This may be a desirable tool for physical therapy for
measuring how deep the tissues are being heated and how rapidly the
damaged tissue is responding and returning to normal blood
flow.
[0118] Regarding solid organs, or tissues, scar tissues should warm
much differently than normal surrounding tissue because of missed
blood flow and over time it would be anticipated that the scar
tissue would cool more slowly since there is less blood flow to
take the warmth away from the scar. This would help physicians
determine whether there was scar tissue or inflammation.
[0119] Within inflamed tissue there should be increased blood flow,
which should have a different warming characteristic of scar tissue
and with the increased blood flow it would be expected that they
inflamed tissue would cool faster as the increased blood flow would
take the temperature away.
[0120] As will be apparent to those skilled in the art in which the
invention is addressed, the present invention may be embodied in
forms other than those specifically disclosed above without
departing from the spirit or potential characteristics of the
invention. Particular embodiments of the present invention
described above are therefore to be considered in all respects as
illustrative and not restrictive. The scope of the present
invention is as set forth in the appended claims and equivalents
thereof rather than being limited to the example contained in the
foregoing description.
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