U.S. patent application number 12/350383 was filed with the patent office on 2009-07-16 for method and system for treating acne and sebaceous glands.
This patent application is currently assigned to Guided Therapy Systems, L.L.C.. Invention is credited to Peter G. Barthe, Inder Raj S. Makin, Michael H. Slayton.
Application Number | 20090182231 12/350383 |
Document ID | / |
Family ID | 38137374 |
Filed Date | 2009-07-16 |
United States Patent
Application |
20090182231 |
Kind Code |
A1 |
Barthe; Peter G. ; et
al. |
July 16, 2009 |
METHOD AND SYSTEM FOR TREATING ACNE AND SEBACEOUS GLANDS
Abstract
A method and system for ultrasound treatment of acne and
sebaceous glands are provided. An exemplary method and system are
configured for targeted treatment of sebaceous glands in various
manners, such as through use of therapy only, therapy and
monitoring, imaging and therapy, or therapy, imaging, and
monitoring, and/or through use of focused, unfocused, or defocused
ultrasound at various spatial and temporal energy settings. An
exemplary method and system can be configured to produce regions of
heating and damage by destroying the function of sebaceous glands
within a user-specified treatment layer depth associated with the
glands to be treated. In addition, an exemplary method and system
can be configured to produce regions of heating and damage within
the treatment layer in spatially defined patterns, rather than
heating and destroying the entire volume of the target layer of
tissue. Further, an exemplary method and system can be configured
to specifically aim such regions of heating and damage within the
treatment layer, to occur at the same location as the secretory
portion of sebaceous glands.
Inventors: |
Barthe; Peter G.; (Phoenix,
AZ) ; Slayton; Michael H.; (Tempe, AZ) ;
Makin; Inder Raj S.; (Mesa, AZ) |
Correspondence
Address: |
SNELL & WILMER L.L.P. (Main)
400 EAST VAN BUREN, ONE ARIZONA CENTER
PHOENIX
AZ
85004-2202
US
|
Assignee: |
Guided Therapy Systems,
L.L.C.
Mesa
AZ
|
Family ID: |
38137374 |
Appl. No.: |
12/350383 |
Filed: |
January 8, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11163177 |
Oct 7, 2005 |
7491171 |
|
|
12350383 |
|
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|
|
60617203 |
Oct 7, 2004 |
|
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Current U.S.
Class: |
600/439 ;
601/2 |
Current CPC
Class: |
A61H 2201/5007 20130101;
A61B 8/12 20130101; A61B 8/4455 20130101; A61N 2007/0034 20130101;
A61B 8/13 20130101; A61B 8/546 20130101; G01S 15/8909 20130101;
A61B 5/682 20130101; A61B 8/4483 20130101; A61B 8/483 20130101;
A61N 7/00 20130101; A61B 8/4209 20130101; A61N 2007/0052 20130101;
A61B 8/4281 20130101; A61N 2007/027 20130101; A61N 7/02 20130101;
A61B 5/6842 20130101; A61B 8/0858 20130101; A61B 2017/320069
20170801; A61N 2007/0008 20130101; A61H 23/0245 20130101; A61B 8/08
20130101; A61B 8/461 20130101 |
Class at
Publication: |
600/439 ;
601/2 |
International
Class: |
A61N 7/00 20060101
A61N007/00; A61B 8/00 20060101 A61B008/00 |
Claims
1. An ultrasound treatment system configured for treatment of acne
and sebaceous glands, said ultrasound treatment system comprising:
a control system for facilitating control of the ultrasound
treatment system; and a probe system configured for targeted
delivery of ultrasound energy to produce a treatment region for
destroying the function of a sebaceous gland.
2. The ultrasound treatment system according to claim 1, wherein
said probe system is configured for destroying the function of said
sebaceous gland within a specified treatment depth identified
through localization of said sebaceous gland.
3. The ultrasound treatment system according to claim 1, wherein
said probe is configured to produce said treatment regions in
spatially defined patterns to facilitate healing of tissue.
4. The ultrasound treatment system according to claim 3, wherein
said spatially defined patterns comprise a discrete locus of spaced
lesions comprising at least one of cross-stitch, cigar-shaped,
ellipsoidal, mushroom-shaped and wedge-shaped lesions.
5. The ultrasound treatment system of claim 1, wherein said control
system comprises an imaging system configured for monitoring of
said treatment region prior to, during and after delivery of
ultrasound energy into said sebaceous gland.
6. The ultrasound treatment system of claim 5, wherein said imaging
system is configured to provide feedback to facilitate said
targeted delivery.
7. The ultrasound treatment system according to claim 1, wherein
said display system comprises a display of images corresponding to
a temperature profile of said treatment region.
8. The ultrasound treatment system according to claim 1, wherein
said probe system comprises an imaging and therapy transducer
configured for targeted delivery of ablative ultrasound within said
treatment region.
9. The ultrasound treatment system according to claim 8, wherein
said imaging and therapy transducer comprise a combined transducer
within an electronic array of transduction elements.
10. The ultrasound treatment system according to claim 8, wherein
said imaging and therapy transducer comprises a single element
array comprising a single transduction element and a plurality of
masks configured for generating a plurality of ablative zones with
each of said plurality of ablative zones providing at least one of
focused, defocused and planar ultrasound energy distribution.
11. The ultrasound treatment system according to claim 1, wherein
said probe is configured for targeted delivery of ultrasound energy
through adjustable control of spatial parameters and temporal
parameters of said probe to generate conformal lesions of
specifically targeted shapes, sizes and orientations.
12. The ultrasound treatment system according to claim 1, wherein
said treatment system comprises an imaging, therapy, and treatment
monitoring system combined with auxiliary imaging and treatment
monitoring apparatus and secondary therapy systems.
13. The ultrasound treatment system according to claim 12, wherein
said auxiliary imaging apparatus comprises at least one of a
photographic instrument and an optical modality.
14. A method for providing treatment of acne and sebaceous glands,
said method comprising: localizing of at least one targeted region
within a region of interest, said localizing configured for
identifying at least one sebaceous gland; targeting of delivery of
ablative ultrasound energy from a transducer probe to said at least
one sebaceous gland; and monitoring of results of said targeted
delivery within said at least one sebaceous gland during and after
said targeted delivery to continue planning of treatment.
15. The method of claim 14, wherein said localizing comprises
imaging a region of interest to identify said at least one
sebaceous gland.
16. The method of claim 14, said targeting of delivery of
ultrasound energy comprises destroying the function of said
sebaceous gland within a specified treatment depth identified
through localization of said sebaceous gland.
17. The method of claim 14, wherein said targeting of delivery
comprises adjustable control of spatial parameters and temporal
parameters of said transducer probe to generate conformal lesions
of specifically targeted shapes, sizes and orientations.
18. The method of claim 14, wherein said targeting of delivery
comprises producing said treatment regions in spatially defined
patterns to facilitate healing of tissue.
19. The method according to claim 18, wherein producing said
spatially defined patterns comprises producing a discrete locus of
spaced lesions comprising at least one of cross-stitch,
cigar-shaped, or wedge-shaped lesions.
20. The method of claim 14, wherein said monitoring of results
comprises measurement of results of treatment of said at least one
sebaceous gland as visualized during and after said target delivery
of ablative ultrasound.
21. The method of claim 14, wherein said monitoring comprises
monitoring the temperature profile of said targeted region.
22. The method of claim 14, wherein said targeted delivery
comprises producing of a matrix of spaced treatment spots
comprising at least one of two-dimensional and three-dimensional
matrix of lesions along a scanned pattern created by scanning of
said transducer probe.
23. The method according to claim 18, wherein producing said
spatially defined patterns comprises producing a discrete locus of
spaced conformal lesions based on control of spatial and temporal
parameters.
24. The method according to claim 14, wherein said localizing
comprises generating three-dimensional imaging information and said
targeting comprises treating three-dimensional treatment
region.
25. The method according to claim 13, wherein said targeting of
delivery further comprises cooling through any tissue regions
between and including skin and said at least one sebaceous gland to
facilitate treatment.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 11/163,177, entitled "Method and System for
Treating Acne and Sebaceous Glands", and filed on Oct. 7, 2005,
which claims priority to and benefit of U.S. Provisional
Application Ser. No. 60/617,203, entitled "Method and System for
Treating Acne and Sebaceous Glands", and filed on Oct. 7, 2004.
FIELD OF INVENTION
[0002] The present invention relates to ultrasound treatment
systems, and in particular to a method and system for treating acne
and sebaceous glands.
BACKGROUND OF THE INVENTION
[0003] Acne vulgaris is the most common skin disorder. Acne causes
temporary and permanent disfigurement. Acne typically appears on
the face, back and/or chest at the onset of adrenarchy, i.e. when
sex hormone activity increases in both boys and girls near puberty.
Acne is a disorder of hair follicles, in which a plug forms within
the outflow tract of the hair follicle. Sebum, an oily product of
sebaceous glands attached to each hair follicle, and cellular
debris builds in the plug. Inflammation and often rupture of the
hair follicles ensues, leading to gross inflammation, pus (a
"whitehead"), pain, bleeding, and/or eventually scarring. If the
acne lesion consists of an accumulated unruptured plug within the
hair follicle, a "blackhead" forms. If the follicle ruptures
superficially, a small pustule forms that often heals after a few
weeks without scarring. If the follicle ruptures within the mid or
deep dermis, a painful cystic abscess forms. Cystic acne usually
heals with permanent and disfiguring scars.
[0004] The exact pathophysiology of acne is complex and is not
fully understood. However, several basic elements are necessary to
produce an acne lesion, and acne therapies are based on attacking
one or more of these basic elements. First, an active sebaceous
gland is necessary. The most potent treatments for acne are oral
retinoids such as retinoic acid (Accutane), which inhibit sebaceous
gland function. Sebaceous gland activity is driven by androgen and
other sex steroid hormones. Women often experience cycle-dependent
acne that may respond to treatment with birth control pills
containing low amounts of progestins. Second, a plug must form in
the outflow tract of the follicle, called the infundibulum.
Bacteria, particularly Proprionobacteria acnes (P acnes) that
digest sebum and follicular debris, contribute to plugging. Topical
retinoids, mild acids and benzoyl peroxide are used as treatments
to decrease follicular plugging. Antibiotics effective against P
acnes are given either topically or orally; the prevalence of
antibiotic-resistant P acnes is increasing. Third, inflammation is
part of the process that breaks down the wall of a follicle
containing plugs, leading to rupture of the follicle with release
of irritating materials into the skin, abscess formation, and
scarring. Anti-inflammatory agents including some antibiotics are
helpful in treating acne.
[0005] The most potent treatment for acne at present is oral
retinoid therapy. Unfortunately, this is a toxic and teratogenic
treatment. Unplanned pregnancies in women taking Accutane lead to a
high rate of fetal malformations. An aggressive program to prevent
this in the US was implemented, but has failed to prevent the
problem. Systemic retinoid treatment also causes major side effects
including extreme dryness during treatment, risk of hepatitis, bone
changes, mood changes, and others. The high effectiveness and high
toxicity of oral retinoids for treatment of cystic acne strongly
suggests that an alternative treatment that targets sebaceous
glands is needed.
SUMMARY OF THE INVENTION
[0006] A method and system for ultrasound treatment of acne and
sebaceous glands are provided. An exemplary method and system are
configured for targeted treatment of sebaceous glands in various
manners, such as through use of therapy only, therapy and
monitoring, imaging and therapy, or therapy, imaging, and
monitoring. Targeted therapy of sebaceous glands can be provided
through use of focused, unfocused, or defocused ultrasound at
various spatial and temporal energy settings.
[0007] An exemplary method and system are configured to produce
regions of heating and damage in various manners. For example, an
exemplary method and system can be configured to produce regions of
heating and damage by destroying the function of sebaceous glands
within a user-specified treatment layer depth associated with the
glands to be treated. In addition, an exemplary method and system
can be configured to produce regions of heating and damage within
the treatment layer in spatially defined patterns, rather than
heating and destroying the entire volume of the target layer of
tissue. Further, an exemplary method and system can be configured
to specifically aim such regions of heating and damage within the
treatment layer, to occur at the same location as the secretory
portion of sebaceous glands.
[0008] In accordance with an exemplary embodiment, an exemplary
treatment system comprises a control system, an imaging/therapy
probe, and display system. The imaging/therapy probe can comprise
various probe and/or transducer configurations. For example, the
probe can be configured for a combined dual-mode imaging/therapy
transducer, coupled or co-housed imaging/therapy transducers, a
therapy probe, or simply a therapy probe and an imaging probe. The
control system and display system can also comprise various
configurations for controlling probe and system functionality,
including for example a microprocessor with software and a
plurality of input/output devices, a system for controlling
electronic and/or mechanical scanning and/or multiplexing of
transducers, a system for power delivery, systems for monitoring,
systems for sensing the spatial position of the probe and/or
transducers, and systems for handling user input and recording
treatment results, among others.
[0009] In accordance with an exemplary embodiment, ultrasound
imaging can be used for safety purposes, namely, to avoid injuring
vital structures. In accordance with another exemplary embodiment,
ultrasound imaging can be used to define the position of a
sebaceous gland and/or the depth of sebaceous glands over a region
of interest. Such glands can be seen lying along hair follicles and
their image may be further enhanced via signal and image
processing.
[0010] In accordance with an exemplary embodiment, ultrasound
therapy via focused, unfocused, or defocused ultrasound, delivered
via an array of foci or array of treatment zones, a locus of foci
or locus treatment zones, a line focus or linear treatment zone, a
surface or volume focus or surface or volume treatment zone, and/or
diffraction patterns from single element, multiple elements,
annular array, one-, two-, or three-dimensional arrays, broadband
transducers, and/or combinations thereof, with or without lenses,
acoustic components, mechanical and/or electronic focusing or
defocusing are utilized to treat sebaceous glands at fixed and/or
variable depth or dynamically controllable depths and
positions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The subject matter of the invention is particularly pointed
out in the concluding portion of the specification. The invention,
however, both as to organization and method of operation, may best
be understood by reference to the following description taken in
conjunction with the accompanying drawing figures, in which like
parts may be referred to by like numerals:
[0012] FIG. 1 illustrates a block diagram of a treatment system in
accordance with an exemplary embodiment of the present
invention;
[0013] FIG. 2A-2E illustrates schematic diagrams of ultrasound
treatment systems configured to treat the sebaceous gland via
direct targeting of heating and damage within the treatment layer
in accordance with various exemplary embodiments of the present
invention;
[0014] FIGS. 3A and 3B illustrate block diagrams of an exemplary
control system in accordance with exemplary embodiments of the
present invention;
[0015] FIGS. 4A and 4B illustrate block diagrams of an exemplary
probe system in accordance with exemplary embodiments of the
present invention;
[0016] FIG. 5 illustrates a cross-sectional diagram of an exemplary
transducer in accordance with an exemplary embodiment of the
present invention;
[0017] FIGS. 6A and 6B illustrate cross-sectional diagrams of an
exemplary transducer in accordance with exemplary embodiments of
the present invention;
[0018] FIG. 7 illustrates exemplary transducer configurations for
ultrasound treatment in accordance with various exemplary
embodiments of the present invention;
[0019] FIGS. 8A and 8B illustrate cross-sectional diagrams of an
exemplary transducer in accordance with another exemplary
embodiment of the present invention;
[0020] FIG. 9 illustrates an exemplary transducer configured as a
two-dimensional array for ultrasound treatment in accordance with
an exemplary embodiment of the present invention;
[0021] FIGS. 10A-10F illustrate cross-sectional diagrams of
exemplary transducers in accordance with other exemplary
embodiments of the present invention;
[0022] FIG. 11 illustrates a schematic diagram of an acoustic
coupling and cooling system in accordance with an exemplary
embodiment of the present invention;
[0023] FIG. 12 illustrates a block diagram of an ultrasound
treatment system combined with additional subsystems and methods of
treatment monitoring and/or treatment imaging as well as a
secondary treatment subsystem in accordance with an exemplary
embodiment of the present invention; and
[0024] FIG. 13 illustrates a schematic diagram with imaging,
therapy, or monitoring being provided with one or more active or
passive oral inserts in accordance with an exemplary embodiment of
the present invention.
DETAILED DESCRIPTION
[0025] The present invention may be described herein in terms of
various functional components and processing steps. It should be
appreciated that such components and steps may be realized by any
number of hardware components configured to perform the specified
functions. For example, the present invention may employ various
medical treatment devices, visual imaging and display devices,
input terminals and the like, which may carry out a variety of
functions under the control of one or more control systems or other
control devices. In addition, the present invention may be
practiced in any number of medical contexts and that the exemplary
embodiments relating to a method and system for treating acne and
sebaceous glands as described herein are merely indicative of
exemplary applications for the invention. For example, the
principles, features and methods discussed may be applied to any
medical application. Further, various aspects of the present
invention may be suitably applied to other applications.
[0026] In patients with acne it is desirable to temporarily or
permanently destroy sebaceous glands. The depth at which these
glands occur is approximately 1-7 mm, depending on skin thickness
and body site. In accordance with various aspects of the present
invention, a method and system for treating acne and sebaceous
glands are provided. For example, in accordance with an exemplary
embodiment, with reference to FIG. 1, an exemplary treatment system
100 configured to treat a region of interest (ROI) 106 comprises a
control system 102, an imaging/therapy probe with acoustic coupling
104, and display system 108.
[0027] Control system 102 and display 108 can comprise various
configurations for controlling functionality of probe 104 and
system 100, including for example a microprocessor with software
and a plurality of input/output and communication devices, a system
for controlling electronic and/or mechanical scanning and/or
multiplexing of transducers, a system for power delivery, systems
for monitoring, systems for sensing the spatial position of the
probe and/or temporal parameters of the transducers, and/or systems
for handling user input and recording treatment input and results,
among others. Imaging/therapy probe 104 can comprise various probe
and/or transducer configurations. For example, probe 104 can be
configured for a combined dual-mode imaging/therapy transducer,
coupled or co-housed imaging/therapy transducers, a separate
therapy probe and separate imaging probe, or a single therapy
probe. In accordance with exemplary embodiments, imaging
transducers may operate at frequencies from approximately 2 to 75
MHz or more, while therapy energy can be delivered at frequencies
from approximately 2 to 50 MHz, with 2 MHz to 25 MHz being
typical.
[0028] With reference to FIG. 2A, an exemplary treatment method and
system are configured for initially imaging a region 222 within a
region of interest 206 and displaying that region 224 on a display
208 to facilitate localization of the treatment area and
surrounding structures, e.g., identification of sebaceous glands
232. After localization, delivery of ultrasound energy 220 at a
depth, distribution, timing, and energy level to achieve the
desired therapeutic effect of thermal ablation to treat a sebaceous
gland 232 is provided. Before, during, and/or after therapy, i.e.,
before, during and/or after delivery of ultrasound energy,
monitoring of the treatment area and surrounding structures can be
conducted to further planning and assessing of the results and/or
providing feedback to control system 202 and a system operator.
[0029] In accordance with an exemplary embodiment, localization can
be facilitated through ultrasound imaging that can be used to
define the position of a sebaceous gland and/or the depth of
sebaceous glands over a region of interest. Such glands can be seen
lying along hair follicles and their image may be further enhanced
via signal and image processing. Ultrasound imaging can also be
used for safety purposes, namely, to avoid injuring vital
structures. In accordance with other exemplary embodiments,
localization can also be accomplished without imaging region 222,
but instead can be based on prior known depths of sebaceous glands
or other target regions.
[0030] For ultrasound energy delivery, probe 204 and/or
imaging/therapy transducers can be mechanically and/or
electronically scanned, for example along direction 226, to place
treatment zones over an extended area. A treatment depth 220 can be
adjusted between a range of approximately 1 to 7 mm, and/or the
greatest depth of sebaceous glands 232. Such delivery of energy can
occur through a repeated "image and burn" technique, i.e., imaging
of the targeted sebaceous gland and then applying ultrasound
energy, or through a "carpet bomb" technique, i.e., applying
ultrasound energy at known depths over an extended area without
initial or ongoing imaging.
[0031] With reference to FIG. 2B, a treated zone 242 may extend
over a line, plane, or surface, or over an extended zone across the
sebaceous gland depth 240 that typically ranges from approximately
1 to 7 mm. Probe 204 can be mechanically and/or electronically
scanned, for example directionally along 226, to extend treatment
zone 242 over a large area. Probe 204 can be further scanned or
moved along a longer directional line 228 to further enlarge
treatment zone 242. For any treated zone 242, as treated zone 242
increases in depth within region of interest 206, the cross
sectional area of treated zone 242 may increase in size from small
to medium to large, i.e., at greater depths, the size of the
treated lesion will increase. Furthermore a treated zone 242 can
have a lesion shape expanding in cross section with depth, and/or
be composed of the fusion of several smaller treatment zones. For
example, a "cross-stitched" series of lesions, a wedge shaped
series of lesions, or any suitably formed conformal lesions can be
crated along treated zone 242.
[0032] The ultrasound beam from probe 204 can be spatially and/or
temporally controlled by changing the spatial parameters of the
transducer, such as the placement, distance, treatment depth and
transducer structure, as well as by changing the temporal
parameters of transducer, such as the frequency, drive amplitude,
and timing, with such control handled via control system 202. Such
spatial and temporal parameters can also be suitably monitored
and/or utilized in open-loop and/or closed-loop feedback systems
within treatment system 200. As a result of such spatial and/or
temporal control, conformal lesions of various, specifically
targeted, shapes, sizes and orientations can be configured along
treatment zone 242.
[0033] In accordance with an exemplary embodiment, with reference
to FIG. 2C, one or more treated zones 242 can be configured to
produce regions of heating and damage within the treatment layer in
spatially defined patterns, such as a discrete locus of spaced
treatment spots or two- or three-dimensional matrix of damage or
destroyed tissue, e.g., a matrix of cross-stitched,
ellipsoidal/cigar-shaped, wedge-shaped, mushroom-shaped or any
other conformal lesions, rather than heating and destroying the
entire volume of the target layer of tissue. In such a treatment
where surrounding regions are spared of damage, the surrounding
undamaged tissue aids rapid healing and recovery.
[0034] In accordance with another exemplary embodiment of the
present invention, with reference to FIG. 2D, an exemplary
monitoring method may comprise monitoring the temperature profile
or other tissue parameters of the region of interest 206, such as
attenuation, speed of sound, or mechanical properties such as
stiffness and strain of the treatment region and suitably adjust
the spatial and/or temporal characteristics and energy levels of
the ultrasound therapy transducer of probe 204. The results of such
monitoring techniques may be indicated on display 208 by means of
one-, two-, or three-dimensional images of monitoring results 250,
or may simply comprise a success or fail-type indicator 252, or
combinations thereof. Additional treatment monitoring techniques
may be based on one or more of temperature, video, profilometry,
and/or stiffness or strain gauges or any other suitable sensing
technique.
[0035] In accordance with another exemplary embodiment, with
reference to FIG. 2E, a treatment system 200 can be configured for
treatment over an expanded treatment region of interest 252 that
includes a combination of tissues, such as subcutaneous fat/adipose
tissue 216 and muscle 218, among others. A multiple of such tissues
may be treated including sebaceous glands in combination with at
least one of epidermis 212, dermis 214, adipose tissue 216,
muscular fascia lying a top muscle tissue 218, mucous membrane,
hair bulb 230, hair shaft 234, hair follicle between hair bulb 230
and epidermis 212, blood vessels, apocrine sweat glands, eccrine
glands lying within dermis 214, fat 216 or muscle 218, and/or any
other tissue of interest. For example, a treatment to region 220 of
sebaceous gland 232 may be performed in combination with treatment
to a region 260 of hair by suitable adjustment of the treatment
spatial and/or temporal parameters of the transducers in probe
204.
[0036] An exemplary control system 202 and display system 208 may
be configured in various manners for controlling probe and system
functionality for providing the various exemplary treatment methods
illustrated above. For example, with reference to FIGS. 3A and 3B,
in accordance with exemplary embodiments, an exemplary control
system 300 can be configured for coordination and control of the
entire therapeutic treatment process to achieve the desired
therapeutic effect of thermal ablation to treat a sebaceous gland.
For example, control system 300 can suitably comprise power source
components 302, sensing and monitoring components 304, cooling and
coupling controls 306, and/or processing and control logic
components 308. Control system 300 can be configured and optimized
in a variety of ways with more or less subsystems and components to
implement the therapeutic system for controlled thermal injury of
sebaceous glands, and the embodiments in FIGS. 3A and 3B are merely
for illustration purposes.
[0037] For example, for power sourcing components 302, control
system 300 can comprise one or more direct current (DC) power
supplies 303 configured to provide electrical energy for entire
control system 300, including power required by a transducer
electronic amplifier/driver 312. A DC current sense device 305 can
also be provided to confirm the level of power going into
amplifiers/drivers 312 for safety and monitoring purposes.
[0038] Amplifiers/drivers 312 can comprise multi-channel or single
channel power amplifiers and/or drivers. In accordance with an
exemplary embodiment for transducer array configurations,
amplifiers/drivers 312 can also be configured with a beamformer to
facilitate array focusing. An exemplary beamformer can be
electrically excited by an oscillator/digitally controlled waveform
synthesizer 310 with related switching logic.
[0039] The power sourcing components can also include various
filtering configurations 314. For example, switchable harmonic
filters and/or matching may be used at the output of
amplifier/driver 312 to increase the drive efficiency and
effectiveness. Power detection components 316 may also be included
to confirm appropriate operation and calibration. For example,
electric power and other energy detection components 316 may be
used to monitor the amount of power going to an exemplary probe
system.
[0040] Various sensing and monitoring components 304 may also be
suitably implemented within control system 300. For example, in
accordance with an exemplary embodiment, monitoring, sensing and
interface control components 324 may be configured to operate with
various motion detection systems implemented within transducer
probe 204 to receive and process information such as acoustic or
other spatial and temporal information from a region of interest.
Sensing and monitoring components can also include various
controls, interfacing and switches 309 and/or power detectors 316.
Such sensing and monitoring components 304 can facilitate open-loop
and/or closed-loop feedback systems within treatment system
200.
[0041] Cooling/coupling control systems 306 may be provided to
remove waste heat from an exemplary probe 204, provide a controlled
temperature at the superficial tissue interface and deeper into
tissue, and/or provide acoustic coupling from transducer probe 204
to region-of-interest 206. Such cooling/coupling control systems
306 can also be configured to operate in both open-loop and/or
closed-loop feedback arrangements with various coupling and
feedback components.
[0042] Processing and control logic components 308 can comprise
various system processors and digital control logic 307, such as
one or more of microcontrollers, microprocessors,
field-programmable gate arrays (FPGAs), computer boards, and
associated components, including firmware and control software 326,
which interfaces to user controls and interfacing circuits as well
as input/output circuits and systems for communications, displays,
interfacing, storage, documentation, and other useful functions.
System software and firmware 326 controls all initialization,
timing, level setting, monitoring, safety monitoring, and all other
system functions required to accomplish user-defined treatment
objectives. Further, various control switches 308 can also be
suitably configured to control operation.
[0043] An exemplary transducer probe 204 can also be configured in
various manners and comprise a number of reusable and/or disposable
components and parts in various embodiments to facilitate its
operation. For example, transducer probe 204 can be configured
within any type of transducer probe housing or arrangement for
facilitating the coupling of transducer to a tissue interface, with
such housing comprising various shapes, contours and
configurations. Transducer probe 204 can comprise any type of
matching, such as for example, electric matching, which may be
electrically switchable; multiplexer circuits and/or
aperture/element selection circuits; and/or probe identification
devices, to certify probe handle, electric matching, transducer
usage history and calibration, such as one or more serial EEPROM
(memories). Transducer probe 204 may also comprise cables and
connectors; motion mechanisms, motion sensors and encoders; thermal
monitoring sensors; and/or user control and status related
switches, and indicators such as LEDs. For example, a motion
mechanism in probe 204 may be used to controllably create multiple
lesions, or sensing of probe motion itself may be used to
controllably create multiple lesions and/or stop creation of
lesions, e.g. for safety reasons if probe 204 is suddenly jerked or
is dropped. In addition, an external motion encoder arm may be used
to hold the probe during use, whereby the spatial position and
attitude of probe 104 is sent to the control system to help
controllably create lesions. Furthermore, other sensing
functionality such as profilometers or other imaging modalities may
be integrated into the probe in accordance with various exemplary
embodiments.
[0044] With reference to FIGS. 4A and 4B, in accordance with an
exemplary embodiment, a transducer probe 400 can comprise a control
interface 402, a transducer 404, coupling components 406, and
monitoring/sensing components 408, and/or motion mechanism 410.
However, transducer probe 400 can be configured and optimized in a
variety of ways with more or less parts and components to provide
treatment of acne and sebaceous, and the embodiments in FIGS. 4A
and 4B are merely for illustration purposes.
[0045] Control interface 402 is configured for interfacing with
control system 300 to facilitate control of transducer probe 400.
Control interface components 402 can comprise multiplexer/aperture
select 424, switchable electric matching networks 426, serial
EEPROMs and/or other processing components and matching and probe
usage information 430 and interface connectors 432.
[0046] Coupling components 406 can comprise various devices to
facilitate coupling of transducer probe 400 to a region of
interest. For example, coupling components 406 can comprise cooling
and acoustic coupling system 420 configured for acoustic coupling
of ultrasound energy and signals. Acoustic cooling/coupling system
420 with possible connections such as manifolds may be utilized to
couple sound into the region-of-interest, control temperature at
the interface and deeper into tissue, provide liquid-filled lens
focusing, and/or to remove transducer waste heat. Coupling system
420 may facilitate such coupling through use of various coupling
mediums, including air and other gases, water and other fluids,
gels, solids, and/or any combination thereof, or any other medium
that allows for signals to be transmitted between transducer active
elements 412 and a region of interest. In addition to providing a
coupling function, in accordance with an exemplary embodiment,
coupling system 420 can also be configured for providing
temperature control during the treatment application. For example,
coupling system 420 can be configured for controlled cooling of an
interface surface or region between transducer probe 400 and a
region of interest and beyond by suitably controlling the
temperature of the coupling medium. The suitable temperature for
such coupling medium can be achieved in various manners, and
utilize various feedback systems, such as thermocouples,
thermistors or any other device or system configured for
temperature measurement of a coupling medium. Such controlled
cooling can be configured to further facilitate spatial and/or
thermal energy control of transducer probe 400.
[0047] In accordance with an exemplary embodiment, with additional
reference to FIG. 11, acoustic coupling and cooling 1140 can be
provided to acoustically couple energy and imaging signals from
transducer probe 1104 to and from the region of interest 1106 and
deeper into tissue, to provide thermal control at the probe to
region-of-interest interface 1110, and to remove potential waste
heat from the transducer probe at region 1144. Temperature
monitoring can be provided at the coupling interface via a thermal
sensor 1146 to provide a mechanism of temperature measurement 1148
and control via control system 1102 and a thermal control system
1142. Thermal control may consist of passive cooling such as via
heat sinks or natural conduction and convection or via active
cooling such as with peltier thermoelectric coolers, refrigerants,
or fluid-based systems comprised of pump, fluid reservoir, bubble
detection, flow sensor, flow channels/tubing 1144 and thermal
control 1142.
[0048] With continued reference to FIG. 4, monitoring and sensing
components 408 can comprise various motion and/or position sensors
416, temperature monitoring sensors 418, user control and feedback
switches 414 and other like components for facilitating control by
control system 300, e.g., to facilitate spatial and/or temporal
control through open-loop and closed-loop feedback arrangements
that monitor various spatial and temporal characteristics.
[0049] Motion mechanism 410 can comprise manual operation,
mechanical arrangements, or some combination thereof. For example,
a motion mechanism 422 can be suitably controlled by control system
300, such as through the use of accelerometers, encoders or other
position/orientation devices 416 to determine and enable movement
and positions of transducer probe 400. Linear, rotational or
variable movement can be facilitated, e.g., those depending on the
treatment application and tissue contour surface.
[0050] Transducer 404 can comprise one or more transducers
configured for treating of acne and sebaceous glands and targeted
regions. Transducer 404 can also comprise one or more transduction
elements and/or lenses 412. The transduction elements can comprise
a piezoelectrically active material, such as lead zirconante
titanate (PZT), or any other piezoelectrically active material,
such as a piezoelectric ceramic, crystal, plastic, and/or composite
materials, as well as lithium niobate, lead titanate, barium
titanate, and/or lead metaniobate. In addition to, or instead of, a
piezoelectrically active material, transducer 404 can comprise any
other materials configured for generating radiation and/or
acoustical energy. Transducer 404 can also comprise one or more
matching layers configured along with the transduction element such
as coupled to the piezoelectrically active material. Acoustic
matching layers and/or damping may be employed as necessary to
achieve the desired electroacoustic response.
[0051] In accordance with an exemplary embodiment, the thickness of
the transduction element of transducer 404 can be configured to be
uniform. That is, a transduction element 412 can be configured to
have a thickness that is substantially the same throughout. In
accordance with another exemplary embodiment, the thickness of a
transduction element 412 can also be configured to be variable. For
example, transduction element(s) 412 of transducer 404 can be
configured to have a first thickness selected to provide a center
operating frequency of approximately 2 kHz to 75 MHz, such as for
imaging applications. Transduction element 412 can also be
configured with a second thickness selected to provide a center
operating frequency of approximately 2 to 50 MHz, and typically
between 2 MHz and 25 MHz for therapy application. Transducer 404
can be configured as a single broadband transducer excited with at
least two or more frequencies to provide an adequate output for
generating a desired response. Transducer 404 can also be
configured as two or more individual transducers, wherein each
transducer comprises one or more transduction element. The
thickness of the transduction elements can be configured to provide
center-operating frequencies in a desired treatment range.
[0052] Transducer 404 may be composed of one or more individual
transducers in any combination of focused, planar, or unfocused
single-element, multi-element, or array transducers, including 1-D,
2-D, and annular arrays; linear, curvilinear, sector, or spherical
arrays; spherically, cylindrically, and/or electronically focused,
defocused, and/or lensed sources. For example, with reference to an
exemplary embodiment depicted in FIG. 5, transducer 500 can be
configured as an acoustic array to facilitate phase focusing. That
is, transducer 500 can be configured as an array of electronic
apertures that may be operated by a variety of phases via variable
electronic time delays. By the term "operated," the electronic
apertures of transducer 500 may be manipulated, driven, used,
and/or configured to produce and/or deliver an energy beam
corresponding to the phase variation caused by the electronic time
delay. For example, these phase variations can be used to deliver
defocused beams, planar beams, and/or focused beams, each of which
may be used in combination to achieve different physiological
effects in a region of interest 510. Transducer 500 may
additionally comprise any software and/or other hardware for
generating, producing and or driving a phased aperture array with
one or more electronic time delays.
[0053] Transducer 500 can also be configured to provide focused
treatment to one or more regions of interest using various
frequencies. In order to provide focused treatment, transducer 500
can be configured with one or more variable depth devices to
facilitate treatment. For example, transducer 500 may be configured
with variable depth devices disclosed in U.S. patent application
Ser. No. 10/944,500, entitled "System and Method for Variable Depth
Ultrasound", filed on Sep. 16, 2004, having at least one common
inventor and a common Assignee as the present application, and
incorporated herein by reference. In addition, transducer 500 can
also be configured to treat one or more additional ROI 510 through
the enabling of sub-harmonics or pulse-echo imaging, as disclosed
in U.S. patent application Ser. No. 10/944,499, entitled "Method
and System for Ultrasound Treatment with a Multi-directional
Transducer", filed on Sep. 16, 2004, having at least one common
inventor and a common Assignee as the present application, and also
incorporated herein by reference.
[0054] Moreover, any variety of mechanical lenses or variable focus
lenses, e.g. liquid-filled lenses, may also be used to focus and or
defocus the sound field. For example, with reference to exemplary
embodiments depicted in FIGS. 6A and 6B, transducer 600 may also be
configured with an electronic focusing array 604 in combination
with one or more transduction elements 606 to facilitate increased
flexibility in treating ROI 610. Array 604 may be configured in a
manner similar to transducer 502. That is, array 604 can be
configured as an array of electronic apertures that may be operated
by a variety of phases via variable electronic time delays, for
example, T.sub.1, T.sub.2 . . . T.sub.j. By the term "operated,"
the electronic apertures of array 604 may be manipulated, driven,
used, and/or configured to produce and/or deliver energy in a
manner corresponding to the phase variation caused by the
electronic time delay. For example, these phase variations can be
used to deliver defocused beams, planar beams, and/or focused
beams, each of which may be used in combination to achieve
different physiological effects in ROI 610.
[0055] Transduction elements 606 may be configured to be concave,
convex, and/or planar. For example, in an exemplary embodiment
depicted in FIG. 6A, transduction elements 606A are configured to
be concave in order to provide focused energy for treatment of ROI
610. Additional embodiments are disclosed in U.S. patent
application Ser. No. 10/944,500, entitled "Variable Depth
Transducer System and Method", and again incorporated herein by
reference.
[0056] In another exemplary embodiment, depicted in FIG. 6B,
transduction elements 606B can be configured to be substantially
flat in order to provide substantially uniform energy to ROI 610.
While FIGS. 6A and 6B depict exemplary embodiments with
transduction elements 604 configured as concave and substantially
flat, respectively, transduction elements 604 can be configured to
be concave, convex, and/or substantially flat. In addition,
transduction elements 604 can be configured to be any combination
of concave, convex, and/or substantially flat structures. For
example, a first transduction element can be configured to be
concave, while a second transduction element can be configured to
be substantially flat.
[0057] With reference to FIGS. 8A and 8B, transducer 404 can be
configured as single-element arrays, wherein a single-element 802,
e.g., a transduction element of various structures and materials,
can be configured with a plurality of masks 804, such masks
comprising ceramic, metal or any other material or structure for
masking or altering energy distribution from element 802, creating
an array of energy distributions 808. Masks 804 can be coupled
directly to element 802 or separated by a standoff 806, such as any
suitably solid or liquid material.
[0058] An exemplary transducer 404 can also be configured as an
annular array to provide planar, focused and/or defocused
acoustical energy. For example, with reference to FIGS. 10A and
10B, in accordance with an exemplary embodiment, an annular array
1000 can comprise a plurality of rings 1012, 1014, 1016 to N. Rings
1012, 1014, 1016 to N can be mechanically and electrically isolated
into a set of individual elements, and can create planar, focused,
or defocused waves. For example, such waves can be centered
on-axis, such as by methods of adjusting corresponding transmit
and/or receive delays, T.sub.1, T.sub.2, T.sub.3 . . . T.sub.N. An
electronic focus can be suitably moved along various depth
positions, and can enable variable strength or beam tightness,
while an electronic defocus can have varying amounts of defocusing.
In accordance with an exemplary embodiment, a lens and/or convex or
concave shaped annular array 1000 can also be provided to aid
focusing or defocusing such that any time differential delays can
be reduced. Movement of annular array 800 in one, two or
three-dimensions, or along any path, such as through use of probes
and/or any conventional robotic arm mechanisms, may be implemented
to scan and/or treat a volume or any corresponding space within a
region of interest.
[0059] Transducer 404 can also be configured in other annular or
non-array configurations for imaging/therapy functions. For
example, with reference to FIGS. 10C-10F, a transducer can comprise
an imaging element 1012 configured with therapy element(s) 1014.
Elements 1012 and 1014 can comprise a single-transduction element,
e.g., a combined imaging/transducer element, or separate elements,
can be electrically isolated 1022 within the same transduction
element or between separate imaging and therapy elements, and/or
can comprise standoff 1024 or other matching layers, or any
combination thereof. For example, with particular reference to FIG.
10F, a transducer can comprise an imaging element 1012 having a
surface 1028 configured for focusing, defocusing or planar energy
distribution, with therapy elements 1014 including a
stepped-configuration lens configured for focusing, defocusing, or
planar energy distribution.
[0060] In accordance with various exemplary embodiments of the
present invention, transducer 404 may be configured to provide one,
two and/or three-dimensional treatment applications for focusing
acoustic energy to one or more regions of interest. For example, as
discussed above, transducer 404 can be suitably diced to form a
one-dimensional array, e.g., transducer 602 comprising a single
array of sub-transduction elements.
[0061] In accordance with another exemplary embodiment, transducer
404 may be suitably diced in two-dimensions to form a
two-dimensional array. For example, with reference to FIG. 9, an
exemplary two-dimensional array 900 can be suitably diced into a
plurality of two-dimensional portions 902. Two-dimensional portions
902 can be suitably configured to focus on the treatment region at
a certain depth, and thus provide respective slices 904 of the
treatment region. As a result, the two-dimensional array 900 can
provide a two-dimensional slicing of the image place of a treatment
region, thus providing two-dimensional treatment.
[0062] In accordance with another exemplary embodiment, transducer
404 may be suitably configured to provide three-dimensional
treatment. For example, to provide-three dimensional treatment of a
region of interest, with reference again to FIG. 1, a
three-dimensional system can comprise a transducer within probe 104
configured with an adaptive algorithm, such as, for example, one
utilizing three-dimensional graphic software, contained in a
control system, such as control system 102. The adaptive algorithm
is suitably configured to receive two-dimensional imaging,
temperature and/or treatment or other tissue parameter information
relating to the region of interest, process the received
information, and then provide corresponding three-dimensional
imaging, temperature and/or treatment information.
[0063] In accordance with an exemplary embodiment, with reference
again to FIG. 9, an exemplary three-dimensional system can comprise
a two-dimensional array 900 configured with an adaptive algorithm
to suitably receive 904 slices from different image planes of the
treatment region, process the received information, and then
provide volumetric information 906, e.g., three-dimensional
imaging, temperature and/or treatment information. Moreover, after
processing the received information with the adaptive algorithm,
the two-dimensional array 900 may suitably provide therapeutic
heating to the volumetric region 906 as desired.
[0064] In accordance with other exemplary embodiments, rather than
utilizing an adaptive algorithm, such as three-dimensional
software, to provide three-dimensional imaging and/or temperature
information, an exemplary three-dimensional system can comprise a
single transducer 404 configured within a probe arrangement to
operate from various rotational and/or translational positions
relative to a target region.
[0065] To further illustrate the various structures for transducer
404, with reference to FIG. 7, ultrasound therapy transducer 700
can be configured for a single focus, an array of foci, a locus of
foci, a line focus, and/or diffraction patterns. Transducer 700 can
also comprise single elements, multiple elements, annular arrays,
one-, two-, or three-dimensional arrays, broadband transducers,
and/or combinations thereof, with or without lenses, acoustic
components, and mechanical and/or electronic focusing. Transducers
configured as spherically focused single elements 702, annular
arrays 704, annular arrays with damped regions 706, line focused
single elements 708, 1-D linear arrays 710, 1-D curvilinear arrays
in concave or convex form, with or without elevation focusing, 2-D
arrays, and 3-D spatial arrangements of transducers may be used to
perform therapy and/or imaging and acoustic monitoring functions.
For any transducer configuration, focusing and/or defocusing may be
in one plane or two planes via mechanical focus 720, convex lens
722, concave lens 724, compound or multiple lenses 726, planar form
728, or stepped form, such as illustrated in FIG. 10F. Any
transducer or combination of transducers may be utilized for
treatment. For example, an annular transducer may be used with an
outer portion dedicated to therapy and the inner disk dedicated to
broadband imaging wherein such imaging transducer and therapy
transducer have different acoustic lenses and design, such as
illustrated in FIG. 10C-10F.
[0066] Moreover, such transduction elements 700 may comprise a
piezoelectrically active material, such as lead zirconante titanate
(PZT), or any other piezoelectrically active material, such as a
piezoelectric ceramic, crystal, plastic, and/or composite
materials, as well as lithium niobate, lead titanate, barium
titanate, and/or lead metaniobate. Transduction elements 700 may
also comprise one or more matching layers configured along with the
piezoelectrically active material. In addition to or instead of
piezoelectrically active material, transduction elements 700 can
comprise any other materials configured for generating radiation
and/or acoustical energy. A means of transferring energy to and
from the transducer to the region of interest is provided.
[0067] In accordance with another exemplary embodiment, with
reference to FIG. 12, an exemplary treatment system 200 can be
configured with and/or combined with various auxiliary systems to
provide additional functions. For example, an exemplary treatment
system 1200 for treatment of acne and sebaceous glands can further
comprise an auxiliary imaging modality 1272 and/or auxiliary
monitoring modality 1274 may be based upon at least one of
photography and other visual optical methods, magnetic resonance
imaging (MRI), computed tomography (CT), optical coherence
tomography (OCT), electromagnetic, microwave, or radio frequency
(RF) methods, positron emission tomography (PET), infrared,
ultrasound, acoustic, or any other suitable method of
visualization, localization, or monitoring of the
region-of-interest, including imaging/monitoring enhancements. Such
imaging/monitoring enhancement for ultrasound imaging via probe
1204 and control system 1202 can comprise M-mode, persistence,
filtering, color, Doppler, and harmonic imaging among others;
furthermore an ultrasound treatment system 1270, as a primary
source of treatment, may be combined with a secondary source of
treatment 1276, including radio frequency (RF), intense pulsed
light (IPL), laser, infrared laser, microwave, or any other
suitable energy source.
[0068] In accordance with another exemplary embodiment, with
reference to FIG. 13, treatment composed of imaging, monitoring,
and/or therapy to a region of interest 1302 and/or 1308 may be
aided, augmented, and/or delivered with passive or active devices
1304 and/or 1306 within the oral and/or nasal cavity, respectively.
For example, if passive or active device 1304 and/or 1306 are
second transducers or acoustic reflectors acoustically coupled to
the mucous membranes it is possible to obtain through transmission,
tomographic, or round-trip acoustic waves which are useful for
treatment monitoring, such as in measuring acoustic speed of sound
and attenuation, which are temperature dependent; furthermore such
transducers could be used to treat and/or image. In addition an
active, passive, or active/passive object 1304 and/or 1306 may be
used to flatten the skin, and/or may be used as an imaging grid,
marker, or beacon, to aid determination of position. A passive or
active device 1304 and/or 1306 may also be used to aid cooling or
temperature control. Natural air in the oral cavity and/or nasal
cavity may also be used as passive device 1304 and/or 1306 whereby
it may be utilized to as an acoustic reflector to aid thickness
measurement and monitoring function.
[0069] The present invention may be described herein in terms of
various functional components and processing steps. It should be
appreciated that such components and steps may be realized by any
number of hardware components configured to perform the specified
functions. For example, the present invention may employ various
medical treatment devices, visual imaging and display devices,
input terminals and the like, which may carry out a variety of
functions under the control of one or more control systems or other
control devices. In addition, the present invention may be
practiced in any number of medical contexts and that the exemplary
embodiments relating to a system as described herein are merely
indicative of exemplary applications for the invention. For
example, the principles, features and methods discussed may be
applied to any medical application. Further, various aspects of the
present invention may be suitably applied to other applications,
such as other medical or industrial applications.
* * * * *