US008992447B2

(12) United States Patent (10) Patent No.: US 8,992.447 B2

Gertner et al. (45) Date of Patent: Mar. 31, 2015
(54) ENERGETIC MODULATION OF NERVES (58) Field of Classification Search
USPC ................................... 600/407 475; 601/24
(75) Inventors: Michael Gertner, Menlo Park, CA See application file for complete search history.
(US); David Perozek, Mercer Island,
WA (US); Jimin Zhang, Bellevue, WA (56) References Cited
(US); Arash Sabet, Ballwin, MO (US) U.S. PATENT DOCUMENTS
(73) Assignee: Kona Medical, Inc., Bellevue, WA (US) 385,256 A 6/1888 Eggers
3,274,437 A 9/1966 Mastrup
(*) Notice: Subject to any disclaimer, the term of this
patent is extended or adjusted under 35 (Continued)
U.S.C. 154(b) by 0 days. FOREIGN PATENT DOCUMENTS
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EP O420758 A1 4f1991
(22) Filed: Jun. 14, 2012
(Continued)
(65) Prior Publication Data OTHER PUBLICATIONS
US 2012/O253.239 A1 Oct. 4, 2012 Final Office Action dated Oct. 16, 2012 for U.S. Appl. No.
13/246,775.
Related U.S. Application Data (Continued)
(63) Continuation of application No. 13/228,366, filed on
Sep. 8, 2011, which is a continuation of application Primary Examiner — Mark Remaly
No. 13/091,116, filed on Apr. 20, 2011, which is a (74) Attorney, Agent, or Firm — Vista IP Law Group, LLP
continuation-in-part of application No. 13/048.830,
(57) ABSTRACT
(Continued) A system for applying focused ultrasound energy to a nerve
(51) Int. C. Surrounding an artery of a patient includes a piezoelectric
A6IB5/05 (2006.01) array comprising a plurality of piezoelectric elements, a con
A61N 7700 (2006.01) troller configured to control at least a subset of the piezoelec
tric elements so that at least one of the piezoelectric elements
(Continued) in the Subset is in a signal transmitting mode, in a signal
(52) U.S. C. sensing mode, or both, a first platform on which the piezo
CPC .............. A61N 7700 (2013.01); A61B 19/5225 electric elements are coupled and a second platform, wherein
(2013.01); A61N 7/02 (2013.01); A61B the second platform is configured to Support at least a part of
2017/00106 (2013.01); A61B 2019/5236 the patient, a programmable generator configured to generate
(2013.01); A61N 2007/003 (2013.01); A61N output power for one or more of the piezoelectric elements,
2007/0078 (2013.01); A61N 2007/0095 and a programmable processor configured to process a signal
(2013.01); sensed by at least one of the piezoelectric elements.
(Continued) 30 Claims, 92 Drawing Sheets

4.
 US 8,992.447 B2
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U.S. Patent Mar. 31, 2015 Sheet 1 of 92 US 8,992.447 B2

Si

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98) 982 984

trasolid pulse Blood pressure Continue therapy

to Carotic Sius OWeed Of aircric
nervous system

No change in BP

988 Discontinue therapy

of at OOC
nervous Syste

988

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U.S. Patent Mar. 31, 2015 Sheet 9 Of 92 US 8,992.447 B2

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U.S. Patent Mar. 31, 2015 Sheet 11 of 92 US 8,992.447 B2
U.S. Patent Mar. 31, 2015 Sheet 12 of 92 US 8,992.447 B2

Parasympathetic 2OO Sympathetic

/ 2128
205 -- Diasates
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pupil 2126
States t
ow of Saiwa -V
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4 OO

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U.S. Patent Mar. 31, 2015 Sheet 15 Of 92 US 8,992.447 B2

or 3 plus
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Refaatefies Data to
irraging with titiaSound
vir SCa" in Coordinate
rane transcucers

eat tisse Energize

transducers

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4740 4.76
475

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48 A820 283

identify ium in via extent of

identify Rib -ass kidney with - surface area aiong
utfascid back of patie

485 Set its of

destify iliac Crest treatient 2s e

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4860 - treatment zone
484 during therapy

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U.S. Patent Mar. 31, 2015 Sheet 20 Of 92 US 8,992.447 B2

49

N 491

Determine position of
biood vessei inside patient

Apply test dose to threshold

of patient sensatio"

Reapply to it,
thesis of Sesator

Aiow Cooling of treatiefit

region

493;

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U.S. Patent Mar. 31, 2015 Sheet 21 of 92 US 8,992.447 B2

495

G. K
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System to inhibit nerves surrounding a blood vesse

4984
a largeting the image of the vesse M

b) Scanning the ength of the vesse,

at east City of the Wesse M

c) Determining the direction of the A388

4975
vesse in a 3-diersionai space

d) Deliver energy along the ength of vesse,

the energy creating a heat cloud around the 4970
vesse, the heat cold stirrounding the vesse for
a region at east 5 from the vessel waii and
aioi"g a length of at east 5.

G.
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G. V.
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F.G. N.
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4988,

G. O.
U.S. Patent Mar. 31, 2015 Sheet 26 of 92 US 8,992.447 B2

4991
(a) Peak intensity along the Z-axis (Depth). -
D=58.7 mm ROC=64.0 mm Freq = 1.13 MHz P=67.6 WTx Motion=0.10 cm

1. O 3. WO 1.
Depth mm)

(b) Thermal Simulation at 1s., 2s, 3s, 4s, 5s and 6s.

FIG. 7P
U.S. Patent Mar. 31, 2015 Sheet 27 Of 92 US 8,992.447 B2

4992
(a) Peak intensity along the Z-axis (Depth). -
D=58.7 mm ROC=64.0 mm Freq = 1.13 MHz P =67.6 WTX Motion=0.00 cm

1 2 . i 1.
Depth (mm)

(b) Thermal Simulation at 1s., 2s, 3s, 4s, 5s and 6s.

FIG. 7O
U.S. Patent Mar. 31, 2015 Sheet 28 Of 92 US 8,992.447 B2
U.S. Patent Mar. 31, 2015 Sheet 29 Of 92 US 8,992.447 B2

5046 -

G. 33
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G. 8C
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5-O

weasure terriperature
aCCCustic power
position radiation
esse

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U.S. Patent Mar. 31, 2015 Sheet 32 Of 92 US 8,992.447 B2
U.S. Patent Mar. 31, 2015 Sheet 33 Of 92 US 8,992.447 B2

53CO 535
argeting Beacon Centray
Coated with vesse

5345

5350
U.S. Patent Mar. 31, 2015 Sheet 34 of 92 US 8,992.447 B2

FG 9A

6005 - f

FG. 9C
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600

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CfMRif Coupied
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patient

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840

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FG. 18A
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877

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8780 878

Cat Resists Cortex N vg. Cortex

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F.G. 6

F.G. 6,

F.G. 6{
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8 Cotic
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Therapy
F.G. 6
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S
5.
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S.
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1100

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1160

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Position patient with Apply

Doppier 8 scar such focussed ultrasound
5O that artery is COSS- s array engthwise
Section relative to along artery
- focus.

/ Obtain Coodinate
1500 -s data from Doppler “
s

G. F.

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168
G. 7
U.S. Patent Mar. 31, 2015 Sheet 51. Of 92 US 8,992.447 B2

88.

F.G. 8
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89

89.3

FG, 9A
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FG 93
U.S. Patent Mar. 31, 2015 Sheet 54 Of 92 US 8,992.447 B2

8945

G. SC
8345
U.S. Patent Mar. 31, 2015 Sheet 55 Of 92 US 8,992.447 B2

- 887
Deivery approach to apply tuirasolic
to rerves surrounding a blood vesse

S36C 896

Determine thickness of eteri?tine (isiance

skin, in scie, kidney iQ. iQod vesse

Determine paia heters to apply puise

837 < is to ramp to teiperature

eierine treatineni parameters 8966 Moving treate focus for

to ramp target region to >200 wicm2 arterior to posterior along
in a least 3s the artery

F.G. 19.
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G. 2
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so N i

912

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G. 13
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934 335) 3.36:

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94.00 940 9420

Modulation of ASSeSSet of Satisfactory

era erves autonomic auto Ofic
response response

943

G. 24.
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944

(G. 5
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385)

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FG, 28.
98.64.

FG. 28G
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387)

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8A6/
U.S. Patent Mar. 31, 2015 Sheet 72 Of 92 US 8,992.447 B2

Embodiment 1 & 2 & 3: Belt W/catheter,

MRI, Ultrasound Imaging

FIG. 28M
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9992

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99.
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FG, 29
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Target skin region

OO3 OO7
(obese subject)
left 878) Right left Right
8,760 876

Surface area
(cm^2)

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1. 2
ENERGETIC MODULATION OF NERVES In terms of treating a patient, delivering energy over a
distance affords great advantages as far as targeting accuracy,
RELATED APPLICATION DATA technologic flexibility, and importantly, limited invasiveness
into the patient. In a simple form, laparoscopic Surgery has
This application is a continuation of U.S. patent applica replaced much of the previous open Surgical procedures and
tion Ser. No. 13/228,366, filed Sep. 8, 2011, pending, which lead to creation of new procedures and devices as well as a
is a continuation of U.S. patent application Ser. No. 13/091, more efficient procedural flow for disease treatment. Laparo
116, filed Apr. 20, 2011, pending, which is a continuation-in scopic tools deliver the Surgeon’s energy to the tissues of the
part of U.S. patent application Ser. No. 13/048.830, filed Mar. 10
patient from a distance and results in improved imaging of the
15, 2011, pending, which is a continuation-in-part of U.S. region being treated as well as the ability for many Surgeons
patent application Ser. No. 12/902,133 filed Oct. 11, 2010, to visualize the region at the same time.
pending, which claims priority to and the benefit of U.S. Perhaps the most important aspect is the fact that patients
Provisional patent application 61/377,908 filed Aug. 27. have much less pain, fewer complications, and the overall
2010, and U.S. Provisional patent application 61/347,375 15 costs of the procedures are lower. Visualization is improved as
filed May 21, 2010, and is a continuation-in-part of U.S. is the ability to perform tasks relative to the visualization.
patent application Ser. No. 12/725,450 filed Mar. 16, 2010, Continued advances in computing, miniaturization and
now pending, which is a continuation-in-part of U.S. patent economization of energy delivery technologies, and
application Ser. No. 12/685,655, filed on Jan. 11, 2010, now improved imaging will lead to still greater opportunities to
pending, which claims priority to and the benefit of U.S. apply energy from a distance into the patient and treat disease.
Provisional Patent Application No. 61/256,983 filed Oct. 31,
2009, U.S. Provisional Patent Application No. 61/250,857 SUMMARY
filed Oct. 12, 2009, U.S. Provisional Patent Application No.
61/261,741 filed Nov. 16, 2009, and U.S. Provisional Patent In some embodiments, a system for applying focused ultra
Application No. 61/291.359 filed Dec. 30, 2009. 25 Sound energy to a nerve Surrounding an artery of a patient
U.S. patent application Ser. No. 12/725,450 also claims includes a piezoelectric array comprising a plurality of piezo
priority to, and the benefit of U.S. Provisional Patent Appli electric elements, a controller configured to control at least a
cation No. 61/303.307 filed Feb. 10, 2010, U.S. Provisional subset of the piezoelectric elements so that at least one of the
Patent Application No. 61/256,983 filed Oct. 31, 2009, U.S. piezoelectric elements in the Subset is in a signal transmitting
Provisional Patent Application No. 61/250,857 filed Oct. 12, 30 mode, in a signal sensing mode, or both, a first platform on
2009, U.S. Provisional Patent Application No. 61/261,741 which the piezoelectric elements are coupled and a second
filed Nov. 16, 2009, and U.S. Provisional Patent Application platform, wherein the second platform is configured to sup
No. 61/291,359 filed Dec. 30, 2009. port at least a part of the patient, a programmable generator
The disclosures of all of the above referenced applications configured to generate output power for one or more of the
are expressly incorporated by reference herein. 35 piezoelectric elements, and a programmable processor con
This application is related to U.S. patent application Ser. figured to process a signal sensed by at least one of the
Nos. 13/048,837, 13/048,842, and 13/048,844, all filed on piezoelectric elements.
Mar. 15, 2011. In other embodiments, a system for delivering energy to
The following patent applications are also expressly incor nerves Surrounding a blood vessel in a patient includes a first
porated by reference herein. 40 ultrasound transducer configured to apply therapeutic energy
U.S. patent application Ser. Nos. 1 1/583,569, 12/762.938, across the blood vessel to heat nerves on both sides of the
1 1/583,656, 12/247,969, 10/633,726, 09/721,526, 10/780, blood vessel, a receiver configured to receive reflected energy
405, 09/747,310, 12/202,195, 11/619,996, 09/696,076, resulting from an ultrasound pulse, and a processor config
11/016,701, 12/887,178, 12/390,975, 12/887,178, 12/887, ured to receive first data from the receiver at a first time point,
211, 12/887,232, 11/583,656. 45 receive second data from the receiver at a second time point,
It should be noted that the subject matters of the above compare the first data with the second data, and provide an
applications and any other applications referenced herein are output signal to a mover to control a position of the first
expressly incorporated into this application as if they are ultrasound transducer.
expressly recited in this application. Thus, in the instance In other embodiments, a system for applying focused ultra
where the references are not specifically labeled as “incorpo 50 Sound energy to a patient includes a piezoelectric array com
rated by reference” in this application, they are in fact deemed prising a plurality of piezoelectric elements, a controller con
described in this application. figured to control at least a subset of the piezoelectric
elements so that at least one of the piezoelectric elements in
BACKGROUND the Subset is in a signal transmitting mode, in a signal sensing
55 mode, or both, a first platform on which the piezoelectric
Energy delivery from a distance involves transmission of elements are coupled, and a second platform, wherein the
energy waves to affect a targetata distance. It allows for more second platform is configured to Support at least a part of the
efficient delivery of energy to targets and a greater cost effi patient, a programmable generator configured to generate
ciency and technologic flexibility on the generating side. For output power for one or more of the piezoelectric elements, a
example, cellular phones receive targets from towers close to 60 programmable processor configured to process a signal
the user and the towers communicate with one another over a sensed by the at least one of the piezoelectric elements, and a
long range; this way, the cellphones can be low powered and medium storing a treatment plan, wherein the treatment plan
communicate over a relatively small range yet the network is configured to be processed by the programmable processor
can quickly communicate across the world. Similarly, elec to cause the piezoelectric array to deliver ultrasound energy
tricity distribution from large generation stations to the users 65 through a skin of the patient about a circumference of a blood
is more efficient than the users themselves looking for solu vessel in the patient, to thereby affect a function of one or
tions. more nerves Surrounding the blood vessel.
 US 8,992,447 B2
3 4
Other and further aspects and features will be evident from FIG.7O depicts a close up of a heat cloud as well as nerves
reading the following detailed description of the embodi leading to the kidney.
mentS. FIGS. 7P-7Q depict modeling and simulation that corre
spond with a dosing and motion control algorithm in accor
DESCRIPTION OF FIGURES 5 dance with some embodiments.
FIG. 8A depicts a percutaneous approach to treating the
FIGS. 1A-1B depict the focusing of energy sources on autonomic nervous system Surrounding the kidneys.
nerves of the autonomic nervous system. FIG. 8B depicts an intravascular approach to treating or
FIG. 1C depicts an imaging system to help direct the targeting the autonomic nervous system.
energy Sources. 10 FIG. 8C depicts a percutaneous approach to the renal hila
FIG. 1D depicts a system integration schematic. using a CT scan and a probe to reach the renal blood vessels.
FIG. 1E depicts a box diagram of an integrated system FIG. 8D depicts an intravascular detection technique to
schematic. characterize the interpath between the blood vessel and the
FIG. 2 depicts targeting and/or therapeutic ultrasound skin.
delivered through the stomach to the autonomic nervous sys- 15 FIGS. 8E-8F depict cross sectional images with focused
tem posterior to the stomach. energy traveling from a posterior direction.
FIG. 3A depicts focusing of energy waves on the renal FIGS. 8G-I depict results of a targeting experiment to
WS. localize an intravascular targeting beacon.
FIG. 3B depicts a coordinate reference frame for the treat FIGS. 9A-9C depicts the application of energy from inside
ment. 2O the aorta to regions outside the aorta to treat the autonomic
FIG.3C depicts targeting catheters or energy delivery cath nervous system.
eters placed in any of the renal vessels. FIG. 10 depicts steps to treat a disease using HIFU while
FIG. 3D depicts an image detection system of a blood monitoring progress of the treatment as well as motion.
vessel with a temporary fiducial placed inside the blood ves FIG. 11A depicts treatment of brain pathology using cross
sel, wherein the fiducial provides positional information with 25 Sectional imaging.
respect to a reference frame. FIG. 11B depicts an image on a viewer showing therapy of
FIG. 3E depicts a therapy paradigm for the treatment and the region of the brain being treated.
assessment of hypertension. FIG.11C depicts another view of a brain lesion as might be
FIG. 4A depicts the application of energy to the autonomic seen on an imaging device which assists in the treatment of
nervous system surrounding the carotid arteries. 30 the lesion.
FIG. 4B depicts the application of energy to through the FIG. 12 depicts treatment of the renal nerve region using a
vessels of the renal hilum. laparoscopic approach.
FIGS. 5A-5B depict the application of focused energy to FIG. 13 depicts a methodology for destroying a region of
the autonomic nervous system of the eye. tissue using imaging markers to monitor treatment progress.
FIG. 5C depicts the application of energy to other auto-35 FIG. 14 depicts the partial treatment of portions of a nerve
nomic nervous system structures. bundle using converging imaging and therapy wave.
FIG. 6 depicts the application of constricting lesions to the FIGS. 15A-15C depict the application of focused energy to
kidney deep inside the calyces of the kidney. the vertebral column to treat various spinal pathologies
FIG. 7A depicts a patient in an imaging system receiving including therapy of the spinal or intravertebral nerves.
treatment with focused energy waves. 40 FIG. 16A depicts the types of lesions which are created
FIG. 7B depicts visualization of a kidney being treated. around the renal arteries to affect a response.
FIG.7C depicts a close up view of the renal nerve region of FIG.16B depicts a simulation of ultrasound around a blood
the kidney being treated. vessel I support of FIG. 16A.
FIG. 7D depicts an algorithmic method to treat the auto FIG.16C depicts data from ultrasound energy applied to
nomic nervous system using MRI and energy transducers. 45 the renal blood vessels and the resultant change in norepi
FIG. 7E depicts a geometric model obtained from cross nephrine levels.
sectional images of the area of the aorta and kidneys along FIGS. 16D-16H depict a simulation of multiple treatment
with angles of approach to the blood vessels and the kidney. spots along a blood vessel.
FIG.7F depicts a close up image of the region of treatment. FIGS. 16I-16K depict various treatment plans of focused
FIG.7G depicts the results of measurements from a series 50 energy around a blood vessel.
of cross sectional image reconstructions. FIGS. 16L-16M depict data indicating that focused energy
FIG.7H depicts the results of measurements from a series applied from the outside can affect sympathetic nerve Supply
of cross-sectional images from a patient in a more optimized to organs.
position. FIG. 16N depicts results of a time course of an experiment
FIG.7I depicts an algorithmic methodology to apply treat- 55 in which sympathetic nerves were inhibited.
ment to the helium of the kidney and apply energy to the renal FIG.17A depicts the application of multiple transducers to
blood vessels. treat regions of the autonomic nervous system at the renal
FIG. 7J depicts a clinical algorithm to apply energy to the hilum.
blood vessel leading to the kidney. FIGS. 17B-17C depict methods for using imaging to direct
FIG. 7K depicts a device to diagnose proper directionality 60 treatment of a specific region Surrounding an artery as well as
to apply energy to the region of the kidney. display the predicted lesion morphology.
FIG.7L depicts a methodology to ablate a nerve around an FIG. 17D depicts a method for localizing HIFU transduc
artery by applying a cloud of heat or neurolytic Substance. ers relative to Doppler ultrasound signals.
FIG.7M depicts a clinical algorithm to apply energy along FIG. 17E depicts an arrangement of transducers relative to
a renal blood vessel. 65 a target.
FIG.7N depicts a cloud of heat to affect the nerves leading FIG. 17F depicts ablation zones in a multi-focal region in
to the kidney. cross-section.