U.S. patent application number 15/403970 was filed with the patent office on 2017-05-04 for percutaneous devices and methods to visualize, target and ablate nerves.
The applicant listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to ROGER N. HASTINGS, TORSTEN SCHEUERMANN, TAT-JIN TEO.
Application Number | 20170120079 15/403970 |
Document ID | / |
Family ID | 46604082 |
Filed Date | 2017-05-04 |
United States Patent
Application |
20170120079 |
Kind Code |
A1 |
SCHEUERMANN; TORSTEN ; et
al. |
May 4, 2017 |
PERCUTANEOUS DEVICES AND METHODS TO VISUALIZE, TARGET AND ABLATE
NERVES
Abstract
Apparatuses for identifying nerve tissue and methods for making
and using the same are disclosed. An example apparatus may include
an elongate shaft having a distal region configured to be
percutaneously deployed within a patient. An active imaging
structure may be disposed on the distal region. The active imaging
structure may be configured to remotely image nerve tissue by
exciting a signal in nerve tissue from a percutaneous location and
receiving the signal from a percutaneous location. The active
imaging structure may include one or more probes.
Inventors: |
SCHEUERMANN; TORSTEN;
(Munich, DE) ; TEO; TAT-JIN; (Santa Clara, CA)
; HASTINGS; ROGER N.; (Maple Grove, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc. |
Maple Grove |
MN |
US |
|
|
Family ID: |
46604082 |
Appl. No.: |
15/403970 |
Filed: |
January 11, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13554391 |
Jul 20, 2012 |
9579030 |
|
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15403970 |
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61509954 |
Jul 20, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/00386
20130101; A61B 2018/0022 20130101; A61B 2018/00577 20130101; A61B
2090/3966 20160201; A61B 5/4029 20130101; A61B 5/0095 20130101;
A61B 18/26 20130101; A61B 8/4461 20130101; A61B 18/24 20130101;
A61N 7/00 20130101; A61B 2018/00494 20130101; A61B 2018/00285
20130101; A61B 5/04001 20130101; A61N 2007/003 20130101; A61B
2018/00023 20130101; A61B 18/1492 20130101; A61N 7/02 20130101;
A61B 18/02 20130101; A61B 5/0071 20130101; A61B 2018/00214
20130101; A61N 2007/0082 20130101; A61N 1/403 20130101; A61B
2018/00791 20130101; A61B 2018/00511 20130101; A61B 2018/00404
20130101; A61B 5/201 20130101; A61B 5/01 20130101; A61N 2007/0091
20130101 |
International
Class: |
A61N 7/02 20060101
A61N007/02; A61B 18/24 20060101 A61B018/24; A61B 18/02 20060101
A61B018/02; A61B 5/00 20060101 A61B005/00; A61B 18/14 20060101
A61B018/14 |
Claims
1.-20. (canceled)
21. A method of imaging and treating targeted nerve tissue, the
method comprising: deploying an elongate shaft having a distal
region to a location within a body lumen of a patient, the shaft
comprising an inflatable balloon along the distal region; expanding
the balloon from a collapsed configuration to an expanded
configuration; rotating a module on the elongate shaft within the
balloon and about a central axis with respect to the balloon and
the elongate shaft, the module comprising one or more light
emitters and a phased array of ultrasonic transducers; remotely
imaging the targeted nerve tissue by exciting a signal in the
targeted nerve tissue from the location and receiving the signal at
the location; wherein the one or more light-emitters emit light
toward the targeted nerve tissue, wherein the phased array of
ultrasonic transducers detect the signal generated by the light in
the targeted nerve tissue; and focusing treatment energy onto the
targeted nerve tissue at a first focal point, which is a distance
from the phased array of ultrasonic transducers, such that the
treatment energy passes through an untreated tissue region to treat
the targeted nerve tissue.
22. The method of claim 21, wherein the light emitted from the one
or more light-emitters is coherent light.
23. The method of claim 21, wherein the one or more light-emitters
emit the light towards a second focal point.
24. The method of claim 23, wherein the one or more light-emitters
are configured to change the depth of focus of the second focal
point.
25. The method of claim 23, wherein the one or more light-emitters
comprise a phased array of light emitting elements.
26. The method of claim 25, wherein the phased array of light
emitting elements is configured to change the radial, longitudinal
and angular location of the second focal point and to change the
depth of focus of the second focal point.
27. The method of claim 21, wherein the phased array of ultrasonic
transducers is configured to change the radial, longitudinal and
angular location of the first focal point and to change the depth
of focus of the first focal point.
28. The method of claim 26, wherein the phased array of ultrasonic
transducers is configured to change the radial, longitudinal and
angular location of the first focal point and to change the depth
of focus of the first focal point.
29. The method of claim 28, wherein the phased array of light
emitting elements and the phased array of ultrasonic transducers
are configured to change the first focal point and the second focal
point to the same radial, longitudinal and angular location.
30. A method of treating a nerve within targeted tissue, the method
comprising: deploying an elongate shaft having a distal region to a
location within a body lumen of a patient, the shaft comprising an
expandable member within the distal region; expanding the member
within the body lumen; rotating a module disposed along the
elongate shaft within the member and about a central axis with
respect to the member and the elongate shaft, the module comprising
a phased array of light emitters and a phased array of ultrasonic
transducers; imaging the targeted tissue by emitting light from the
phased array of light emitters toward the targeted tissue to excite
a signal in the targeted tissue, and detecting the signal generated
by the light in the targeted tissue at the phased array of
ultrasonic transducers; and focusing treatment energy onto the
targeted tissue at a first focal point, which is a distance from
the phased array of ultrasonic transducers, such that the treatment
energy passes through an untreated tissue region to treat the nerve
within the targeted tissue.
31. The method of claim 30, wherein the phased array of
light-emitters emits light towards a second focal point.
32. The method of claim 31, wherein the phased array of
light-emitters is configured to change the depth of focus of the
second focal point.
33. The method of claim 31, wherein the phased array of light
emitters is configured to change the radial, longitudinal and
angular location of the second focal point and to change the depth
of focus of the second focal point.
34. The method of claim 30, wherein the phased array of ultrasonic
transducers is configured to change the radial, longitudinal and
angular location of the first focal point and to change the depth
of focus of the first focal point.
35. The method of claim 33, wherein the phased array of ultrasonic
transducers is configured to change the radial, longitudinal and
angular location of the first focal point and to change the depth
of focus of the first focal point.
36. The method of claim 35, wherein the phased array of light
emitting elements and the phased array of ultrasonic transducers
are configured to change the first focal point and the second focal
point to the same radial, longitudinal and angular location.
37. A method of treating a nerve within targeted tissue, the method
comprising: deploying an elongate shaft having a distal region to a
location within a body lumen of a patient, the shaft comprising an
inflatable balloon along the distal region; inflating the balloon
within the body lumen; rotating one or more light emitters and a
phased array of ultrasonic transducers disposed along the elongate
shaft within the balloon and about a central axis of the elongate
shaft; emitting light from the one or more light emitters toward
the targeted tissue to excite a signal in the targeted tissue, and
detecting the signal at the phased array of ultrasonic transducers;
and focusing treatment energy onto the targeted tissue to treat the
nerve within the targeted tissue.
38. The method of claim 37, wherein the one or more light emitters
comprises a phased array of a plurality of light emitters.
39. The method of claim 37, wherein the focusing step further
comprises focusing the treatment energy onto the targeted tissue at
a first focal point, which is a distance from the phased array of
ultrasonic transducers, such that the treatment energy passes
through an untreated tissue region to treat the nerve within the
targeted tissue.
40. The method of claim 37, wherein the one or more light-emitters
emit pulses of coherent light.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. .sctn.119
to U.S. Provisional Application Ser. No. 61/509,954, filed Jul. 20,
2011, the entirety of which is incorporated herein by
reference.
TECHNICAL FIELD
[0002] The present invention is related to systems and methods for
visualizing, targeting and ablating nerves including the disruption
of sympathetic nerve activity. Some embodiments of the invention
are related to systems and methods for improving renal and/or
cardiac function through neuromodulation.
BACKGROUND
[0003] Nerve modulation therapies such as nerve ablation are
beneficial for certain conditions. For example, sympathetic renal
activity connected with congestive heart failure may cause unwanted
symptoms such as fluid retention. Interrupting this sympathetic
nerve activity may mitigate these symptoms. One technique for
interrupting the renal sympathetic nerve activity is to ablate the
sympathetic nerves, which are disposed in part around the renal
arteries. Typical renal nerve ablation therapies involve the
introduction of an ablation catheter into the renal arteries and
ablating the arteries at various longitudinal and radial locations
along the arteries. This procedure is done without identifying the
specific location of the nerve tissue or identifying the nerve
tissue.
SUMMARY
[0004] Being able to identify the nerve tissue may allow for more
targeted and thus less traumatic therapies. A therapy which
identifies the nerve tissue in conjunction (i.e. before, during
and/or after) with a nerve modulation technique such as ablation
may be useful in such renal procedures as well as procedures
elsewhere in the body.
[0005] One embodiment pertains to an apparatus for percutaneously
identifying nerve tissue that includes an elongate shaft for
percutaneous deployment and an active imaging structure disposed on
the distal region of the elongate shaft. The imaging structure may
be configured to remotely image nerve tissue by exciting a signal
in nerve tissue from a percutaneous location and receiving the
signal from a percutaneous location. The imaging structure may
include a first percutaneous probe for exciting the signal and a
second percutaneous probe for receiving the signal, or may include
a single percutaneous probe that both excites and receives the
signal. In another alternative, the signal excitation may be
provided by an extracorporeal device and the probe may receive
signal excited by the extracorporeal probe.
[0006] The elongate shaft can also include, in the distal region, a
fixation element that has a collapsed configuration and an expanded
configuration. Examples of such fixation elements include
inflatable balloons and self-expanding stent-like structures. The
probe or probes may be mounted on a module at the distal region,
and the module may be rotatable and/or longitudinally and/or
radially movable with respect to the elongate shaft. The module may
be located within the fixation element, in which case, the module
may be rotatable or longitudinally or radially movable with respect
to the fixation element as well. An actuation device may be
operatively connected to the module to provide such movement.
[0007] The probe may be a photo-acoustic sensor comprising a radio
frequency-emitter such as a light emitter and a phased array of
transducers. The light-emitter may be configured to emit light
towards a defined location and to change the intensity of the
emission and the location of the emission relative to the probe.
The light-emitter may comprise an element that can emit discrete
pulses of light and may comprise a phased array of light emitting
elements that can emit coherent light. A signal processor is
preferably operatively connected to the probe. The signal processor
may be used to process the signals from the probe and may be used
in conjunction with the probe to image the nerve tissue and can be
configured to use the signal from the probe to measure
temperature.
[0008] The elongate shaft can also include a nerve modulation
element in the distal region such as, for example, an ablation
element. The ablation element is preferably configured to focus
energy at a distance from the nerve modulation element such that
the energy can pass through a first tissue to modulate the nerve
tissue. The nerve modulation element can be an ultrasonic ablation
element and can be configured to ablate the nerve tissue.
[0009] One embodiment pertains to a method of nerve modulation that
includes the steps of identifying nerve tissue to be modulated from
a percutaneous location in the body and modifying the nerve tissue
from a percutaneous location. The nerve tissue to be identified may
be spaced apart from the probe doing the identification and may be
separated from the probe by intervening tissue. The method can also
include the step of identifying changes in the nerve tissue during
the modulation of the nerve tissue such as changes in
temperature.
[0010] In some variations of the method, a dye that preferentially
dyes or is otherwise preferentially taken up by nerve tissue is
introduced to the region of interest. The identification of nerve
tissue may thus be aided by this dye, which may be more responsive
to the excitation signals than the nerve tissue itself. One
contemplated sensor to be used during identification is a
photo-acoustic sensor.
[0011] The modulation of the nerve tissue may be done by a probe
spaced apart from the nerve tissue. Energy may be passed through a
first tissue non-destructively to focus on the nerve tissue to
target and ablate nerve tissue. An ultrasonic ablator comprising a
phased array of transducers may be used to focus ultrasonic energy
for the nerve modulation.
[0012] Within the structure of the embodiment described above, and
expanding from these embodiments, a wide variety of alternatives
are contemplated. Elements of these alternative embodiments will be
described below.
[0013] For example, the elongate shaft may be a catheter, stylus or
needle configured for percutaneous deployment. The excitation probe
may be a separate element that is either another percutaneous
member or on a member designed to be used outside the body and in
conjunction with the receiving probe on the elongate shaft. In
general, the apparatus may be configured for percutaneous
deployment, intravascular deployment or deployment through any body
opening or lumen, natural or man-made.
[0014] The probe may be configured to preferentially excite a
signal in nerve tissue while exciting substantially no signal in
other body tissue such as the non-nerve tissue of a blood vessel
wall. To preferentially excite such a signal, the probe may be
configured to emit light, coherent light or laser light in an
appropriate part of the spectrum such as in the infrared region of
the spectrum, the near infrared region, the visible region or the
ultraviolet region, and may thereby excite fluorescence or other
return signal from the nerve tissue.
[0015] In some configurations, the apparatus may work with a dye
that has been applied in the region of interest. The dye may be a
dye that preferentially dyes nerve tissue or molecules found in
greater concentration in nerve tissue and preferentially fails to
dye non-nerve tissue. The probe may excite fluorescence from such a
dye. Conversely, the dye may be one that preferentially avoids
nerve tissue. The probe, when exciting an image from such a dye by
fluorescing or other means, may thus create a sort of negative
image of the nerve tissue.
[0016] The probe may be configured to receive a light signal or an
acoustic signal. In some cases, the excitation signal is a light
signal such as a laser and the receiving signal is a light signal.
In some cases, the excitation signal is a light signal such as a
laser or an RF signal and the receiving signal is an acoustic
signal (e.g. photo-acoustics). In some cases, the excitation signal
is an acoustic signal and the receiving signal is an acoustic
signal (e.g. ultrasound).
[0017] When the probe is configured to generate an acoustic signal,
the signal may be an ultrasound signal. The ultrasound signal may
have a frequency of less than 100 MHz, or a frequency of less than
90 MHz, or a frequency of less than 80 MHz and may also have a
frequency of greater than 20 MHz or a frequency of greater than 40
MHz, or a frequency of greater than 60 MHz or have other suitable
frequencies. The probe may also be used to generate ultrasonic
frequencies suitable for ablation.
[0018] The apparatus may generally include driver electronics
coupled to the probe and coupled to the receiver probe. There may
be a controller coupled to the driver electronics and configured to
control activation of the probe.
[0019] In some cases, the probe may comprise a phased array of
emitters and the controller may be configured to control activation
of each of the emitters in the phased array of emitters. The
controller may be configured to electronically adjust a depth of
focus of the phased array of emitters by selective and timed
activation of the individual emitters in the phased array. A
location of a focal point of the phased array of emitters may be
adjusted in similar fashion. For example, the control may be
configured to move the focal point of the phased array of emitters
longitudinally with respect to the catheter and/or configured to
move the focal point of the phased array of emitters radially with
respect to the catheter. In addition, the controller may adjust the
angular orientation of the focal point.
[0020] The receiving probe may comprise a phased array of receiving
elements operatively connected to the controller. The depth of
focus, radial, longitudinal and angular location of the focal point
of the phased array of receiving elements can be adjusted through
the controller. The emitters, receiving elements, and/or unified
probe elements may be transducers or other elements appropriate to
the sensing technology used.
[0021] The apparatus may comprise a probe actuator for moving the
probe on the catheter radially and/or longitudinally and/or
rotationally. Further, any of the phased arrays may further
comprise a plurality of element actuators for individually
adjusting the elements in the phased array.
[0022] The apparatus may further comprise a positioning element
such as a centering element that fixes the distal region of the
catheter in the center of a blood vessel or against a vessel wall.
The positioning element may comprise a balloon, a non-occluding
balloon such as a multi-lobed balloon or a balloon comprising an
expandable helical element. The balloon may have a transparent
balloon wall and may have a transparent expansion fluid.
Alternative positioning elements may be self-expanding positioning
elements such as a plurality of struts biased to an expanded state
or a stent-like element.
[0023] The probe may be located at any convenient location. For
example, the probe may be located between the proximal and distal
ends of the centering element, distal of the distal end of the
centering element, or proximal of the proximal end of the centering
element. The probe and the receiving probe may overlap
longitudinally along the longitudinal axis of the catheter.
[0024] Some embodiments further include an ablation element
disposed in the distal region. The ablation element may be
configured to focus energy at a distance by producing energy that
passes through a first body tissue and ablates a second body tissue
at a predetermined point. In general, the energy focuses at the
predetermined point and is thus too dispersed in the area of the
first body tissue to modulation or otherwise affect the first
tissue. The ablation element may use any suitable ablation
technology such as ultrasound, electromagnetic energy such as radio
frequency, microwave energy, laser light or cryogenic energy. In
general, ultrasound and light are the technologies most suitable
for use with systems that focus the ablation energy at a distance
to pass through intervening tissue. The ablation element may
comprise an array of energy elements that are configured to be used
cooperatively to ablate targeted tissue, such as a phased array of
transducers. It is possible for the probe function and the ablation
function to use the same transducers. The phased array has a focal
point that may be adjusted as previously described.
[0025] One example embodiment is a needle or other percutaneous
device having a renal modulation element and a sensing element such
as an ultrasound element or a photo-acoustic element or portion of
a photo-acoustic element. In the case of the photo-acoustic
element, the excitation element may be on the probe or may be a
separate component. The renal nerve modulation element may be an
ultrasound element or other suitable element such as those
described above or a drug delivery element.
[0026] Naturally, any of the apparatuses described above can be
used in a method of moving the distal region of the apparatus
percutaneously to the region of interest, exciting a signal, and
receiving the signal. Further steps preferably include processing
the receiving signal, and communicating the received signal from
the apparatus by, for example, displaying the received signal on an
electronic display. Ways of displaying the signal include
displaying the received signal in a graph or on an image of the
region of interest. The communication of the received signal may
also include providing an auditory indication.
[0027] The probe may be moved rotationally and/or longitudinally
through the region of interest while activating the probe to excite
the signal. In some embodiments, the probe is moved after moving a
positioning and/or fixation element to the expanded position, and
the probe is moved relative to the positioning element.
[0028] The activation of the probe generally comprises exciting a
signal in nerve tissue. The signal may be, for example, a
fluorescing of the nerve tissue or an acoustic signal. In some
methods, a dye that preferentially binds to nerve tissue is
provided in the region of interest. The dye maybe provided
percutaneously, intravascularly or orally and may be provided
through a separate injection system.
[0029] The activation of the probe may comprise generating light
such as laser light, ultraviolet light, infrared light or other
suitable light or radiofrequency energy, or generating ultrasound
energy. The ultrasound energy may be provided at a frequency of
less than about 100 MHz or 80 MHz, and/or a frequency of greater
than 20 MHz, 40 MHz, or 60 MHz. The activation of the probe may
further comprise modulating emitted energy by, for example,
emitting energy towards a focal point. One may select a focal point
at a predetermined location at a distance from the probe and
emitting energy to maximize the energy at the predetermined
location. One may modulate by emitting energy towards the focal
point while changing a characteristic of the focal point (e.g.
changing a radial distance of the focal point to the probe,
changing a longitudinal location relative the probe, changing a
radial location relative the probe, changing an intensity of the
energy at the focal point, widening the focal point, or changing an
intensity of the energy at the focal point may comprise increasing
or decreasing the amount of energy emitted by the probe).
[0030] The step of receiving the signal may comprise the step of
receiving an acoustic wave. A controller can be used to selectively
process the received signal to determine characteristics of the
tissue at locations spaced away from the receiving element. For
example, using a phased array of receiving elements, one can focus
on receiving a signal from a particular location spaced away from
the phased array. This location can be modified as described above
and may be synchronized with the focal point of the excitation
signal.
[0031] With those embodiments that include an ablation element, the
method may further comprise the step of activating the ablation
element. The ablation element may have a focal point like the
excitation element above, and the focal point may be modified in
like manner. One may track changes in the signals over time, and
identify the differences in the signals. This may help identify the
location of any ablation and the effectiveness of the ablation
procedure. One can image the area prior to the ablation treatment
and in some cases continue to image the area during the ablation
treatment or intermittently image the area during or between
ablation treatments. In some methods, one can use ultrasonic
signals to measure temperature. One may sequentially determine a
treatment location and then ablate at the treatment location, and
then repeat the process as desired.
[0032] These methods may be used in any region of the body,
including but not limited to a renal artery, a coronary artery, a
vein, a descending aorta, an organ, a stomach, a colon, a trachea
or other area of interest.
[0033] The above summary of some example embodiments is not
intended to describe each disclosed embodiment or every
implementation of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] Embodiments of the invention may be more completely
understood in consideration of the following detailed description
of various embodiments in connection with the accompanying
drawings, in which:
[0035] FIG. 1 is a diagram of an example nerve imaging and
modulation catheter;
[0036] FIG. 2 is a cut-away diagram illustrating details at the
distal end of the catheter;
[0037] FIG. 3A illustrates the distal end of an example catheter in
situ;
[0038] FIG. 3B illustrates the distal end of the example catheter
of FIG. 3A in situ.
[0039] While the invention is amenable to various modifications and
alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in detail. It should
be understood, however, that the intention is not to limit aspects
of the invention to the particular embodiments described. On the
contrary, the intention is to cover all modifications, equivalents,
and alternatives falling within the spirit and scope of the
invention.
DETAILED DESCRIPTION
[0040] For the following defined terms, these definitions shall be
applied, unless a different definition is given in the claims or
elsewhere in this specification.
[0041] All numeric values are herein assumed to be modified by the
term "about", whether or not explicitly indicated. The term "about"
generally refers to a range of numbers that one of skill in the art
would consider equivalent to the recited value (i.e., having the
same function or result). In many instances, the term "about" may
be indicative as including numbers that are rounded to the nearest
significant figure.
[0042] The recitation of numerical ranges by endpoints includes all
numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75,
3, 3.80, 4, and 5).
[0043] Although some suitable dimensions ranges and/or values
pertaining to various components, features and/or specifications
are disclosed, one of skill in the art, incited by the present
disclosure, would understand desired dimensions, ranges and/or
values may deviate from those expressly disclosed.
[0044] As used in this specification and the appended claims, the
singular forms "a", "an", and "the" include plural referents unless
the content clearly dictates otherwise. As used in this
specification and the appended claims, the term "or" is generally
employed in its sense including "and/or" unless the content clearly
dictates otherwise.
[0045] The terms "preferential" and "preferentially" mean that the
modified element is disproportionally affected relative to other
elements. For example, the phrase "preferentially exciting a signal
in nerve tissue" means the excitation of the signal in nerve tissue
is greater than in other tissue. This is in contrast to merely
exciting a signal in nerve tissue, which may be understood to mean
that other tissues may be equally excited, or non-preferentially
exciting a signal in nerve tissue, which may be understood to mean
that other tissues are equally excited
[0046] The following detailed description should be read with
reference to the drawings in which similar elements in different
drawings are numbered the same. The detailed description and the
drawings, which are not necessarily to scale, depict illustrative
embodiments and are not intended to limit the scope of the
invention. The illustrative embodiments depicted are intended only
as exemplary. Selected features of any illustrative embodiment may
be incorporated into an additional embodiment unless clearly stated
to the contrary.
[0047] FIG. 1 is a diagram of an example imaging and nerve
modulation catheter 100 that can be employed to identify nerve
tissue and deliver a localized therapy to the nerve tissue. As
shown in one implementation, the catheter 100 includes a distal
inflatable balloon portion 102 that can be routed to a treatment
site inside a patient to image and deliver therapy to that
treatment site; a proximal end 104 that remains outside a patient
during treatment and facilitates connection of various equipment to
the catheter 100; and an elongate member or catheter shaft 106 that
couples the proximal-end equipment to the distal inflatable balloon
portion.
[0048] The catheter's elongate member 106 may include one or more
internal lumens (not shown in FIG. 1). The lumens allow inflation
fluid to be delivered distally from an external inflation fluid
source 108 to an internal chamber of the balloon 102. The elongate
member 106 also includes conductors (not shown) that carry
electrical signals from components such as sensing elements (e.g.,
sensing elements 112a, 112b, which can be seen in FIG. 2) and
ablation elements (e.g., ablation element 114, which can be seen in
FIG. 2) in the balloon 102 to a signal processor 110 at the
proximal end of the catheter 100.
[0049] The signal processor 110 can process the electrical signals
to electrically characterize signals from the sensing elements
112a/112b. In particular, the signal processor 110, in some
implementations, generates visual displays, such as isochronal or
isopotential maps of the tissue, which a physician may use to
identify aberrant electrical pathways at locations in the body
tissue that may be candidates for nerve modulation or maps which a
physician may use to identify nerve tissue. The visual displays may
be provided in a user interface 116 (e.g., a flat panel display, or
other suitable output device).
[0050] The signal processor 110 can include circuitry for receiving
acoustic or light signals or biopotential signals (e.g.,
differential amplifiers or other amplifiers that sense biopotential
signals and amplify them to levels that can be used in further
processing) and processing the signals in a manner that permits
their subsequent analysis, for example by a medical professional
delivering or considering delivering therapy to a patient.
[0051] In some implementations, the signal processor 110 includes
dedicated circuitry (e.g., discrete logic elements and one or more
microcontrollers; application-specific integrated circuits (ASICs);
or specially configured programmable devices, such as, for example,
programmable logic devices (PLDs) or field programmable gate arrays
(FPGAs)) for processing biopotential signals and displaying a
graphical representation of the signals in a user interface. In
some implementations, the signal processor 110 includes a general
purpose microprocessor and/or a specialized microprocessor (e.g., a
digital signal processor, or DSP, which may be optimized for
processing graphical or a biometric information) that executes
instructions to receive, analyze and display information associated
with the received signals. In such implementations, the signal
processor 110 can include program instructions, which when
executed, perform part of the signal processing. Program
instructions can include, for example, firmware, microcode or
application code that is executed by microprocessors or
microcontrollers. The above-mentioned implementations are merely
exemplary, and the reader will appreciate that the signal processor
110 can take any suitable form.
[0052] A controller 118 at the proximal end can control the sensing
elements 112a/112b and/or the nerve modulation elements 114 to
generate probing signals and/or therapeutic emissions. In some
embodiments, a separate controller may be used for controlling the
nerve modulation elements 114. The controller 118 itself can take
many different forms. In some implementations, the controller 118
is a dedicated electrical circuit employing various sensors, logic
elements and actuators. In other implementations, the controller
118 is a computer-based system that includes a programmable
element, such as a microcontroller or microprocessor, which can
execute program instructions stored in a corresponding memory or
memories. Such a computer-based system can take many forms, include
many input and output devices (e.g., a user interface and other
common input and output devices associated with a computing system,
such as keyboards, point devices, touch screens, discrete switches
and controls, printers, network connections, indicator lights,
etc.) and may be integrated with other system functions, such as
monitoring equipment, a computer network, other devices that are
typically employed during a procedure, etc. For example, a single
computer-based system may include a processor that executes
instructions to provide the controller function, display imaging
information associated with a procedure (e.g., from an imaging
device); display pressure, temperature and time information (e.g.,
elapsed time since a given phase of treatment was started); and
serve as an overall interface to the catheter 100. In general,
various types of controllers are possible and contemplated, and any
suitable controller 118 can be employed. Moreover, in some
implementations, the controller 118 and the signal processor 110
may be part of a single computer-based system, and both control and
signal processing functions may be provided, at least in part, by
the execution of program instructions in a single computer-based
system.
[0053] The catheter 100 shown in FIG. 1 is an over-the-wire type
catheter. Such a catheter 100 uses a guidewire 120, extending from
the distal end of the catheter 100. In some implementations, the
guidewire 120 may be pre-positioned inside a patient's body; once
the guidewire 120 is properly positioned, the balloon 102 (in a
deflated state) and the elongate member 106 can be routed over the
guidewire 120 to a treatment site. In some implementations, the
guidewire 120 and balloon portion 102 of the catheter 100 may be
advanced together to a treatment site inside a patient's body, with
the guidewire 120 leading the balloon 102 by some distance (e.g.,
several inches). When the guidewire portion 120 reaches the
treatment site, the balloon 102 may then be advanced over the
guidewire 120 until it also reaches the treatment site. Other
implementations are is contemplated, such as steerable catheters
that do not employ a guidewire. Moreover, some implementations
include an introducer sheath that can function similar to a
guidewire, and in particular, that can be initially advanced to a
target site, after which other catheter portions can be advanced
through the introducer sheath.
[0054] The catheter 100 can include a manipulator (not shown), by
which a medical practitioner may navigate the guidewire 120 and/or
balloon 102 through a patient's body to a treatment site. In some
implementations, release of cryogenic fluid into a cooling chamber
may inflate the balloon 102 to a shape similar to that shown in
FIG. 1. In other implementations, a pressure source 108 may be used
to inflate the balloon 102 independently of the release of
cryogenic fluid into the internal chamber of the balloon 102. The
pressure source 108 may also be used to inflate an anchor member on
the end of the guidewire 120 (not shown).
[0055] The catheter 100 includes a connector for connecting to the
user interface 116, the controller 118 and the signal processor
110. The user interface may include monitoring equipment that may
be used, for example, to monitor temperature or pressure at the
distal end of the catheter 100. As indicated above, the monitoring
equipment may be integrated in a single system that also provides
the controller and signal processor. To aid in positioning the
balloon 102 of the catheter 100 inside a patient's body, various
marker bands (not shown) can also be disposed at the distal and
proximal ends of the catheter 100. The marker bands may be
radio-opaque when the catheter is viewed by x-ray or other imaging
techniques. Other variations in the catheter 100 are contemplated.
A guidewire may be arranged differently than shown, and may be
separately controlled from the balloon portion of the catheter.
Moreover, in some implementations, a guidewire may not be used.
[0056] FIG. 2 illustrates some of the internal details of balloon
102. The balloon 102 includes a balloon wall 122 that may be formed
from a polymer including, but not limited to, polyolefin copolymer,
polyester, polyethylene terephthalate, polyethylene,
polyether-block-amide, polyamide, polyimide, nylon, latex, or
urethane. Balloon wall 122 is preferably transparent and is also
preferably compliant. Balloon 102 includes an inner module 124 that
may carry the sensing element 112a/112b and the nerve modulation
elements 114. The inner module 124 may be cylindrical and may be
rotatably mounted with respect to the balloon. An electrical
actuation element 126 may allow rotation of the inner module 124
with respect to the balloon.
[0057] The sensing elements 112a/112b may be configured to identify
nerve tissue and may comprise photo-acoustic elements, ultrasound
elements, light sensors or other suitable nerve detection
elements.
[0058] Photo-acoustic imaging uses the physical phenomenon of an
acoustic wave being produced from a sample that is stimulated using
electromagnetic energy. Generally, the tissue is irradiated using
high-intensity pulses of light or radiofrequency energy. These
pulses are preferably short (1-100 ns). The wavelength of the
pulsed of light may vary and, in some embodiments, may be in the
range of about 400-500 nm (e.g., 450 nm) or, in some other
embodiments, may be about 1200 nm or greater. These are just
examples. Broadband acoustic waves are then generated from
absorption of the energy in the tissue within the irradiated
volume. Short (e.g. nanosecond) pulses may generate the highest
resolution acoustic return signals. The acoustic return signals can
be detected using an ultrasound detector and subsequently processed
to provide spatial organization to generate an image of the target
tissue. The strength of the acoustic return signal is related to
the intensity and the wave-length of the pulses of coherent light
and also related to the local optical absorption coefficient of the
target tissue. Using photo-acoustic imaging, it is possible to
distinguish between different tissue types at a high level of
resolution (e.g. on the order of about 20-200 micrometers). Using
preferential contrast dyes that have high optical absorption
coefficients, photo-acoustic imaging techniques may be performed on
the cellular and molecular level.
[0059] Sensing elements 112a may be configured to emit pulses of
coherent light (e.g., having a wavelength in the range of about
400-500 or having a wavelength of about 1200 nm or greater) and
sensing elements 112b may be configured to receive acoustic signals
generated by the pulses of coherent light in the nerve tissue. For
example, sensor elements 112a may be laser diodes and sensor
elements 112b may be transducers. Sensor elements 112a preferably
are configured to focus the coherent light at a focus point. The
focus point may be a predetermined focus point or may be movable.
The focus point may, for example be moved through the use of
element actuators (not shown) under each of the sensor elements
112a, through using sensor elements 112a as a phased array, through
the use of one or more lenses or other suitable means. The sensor
elements 112b (the receiving elements) may be configured as a
phased array, which allows either the elements or the controller
118 or signal processor 110 to determine where the reflected
signals are coming from. In this manner, a three dimensional map
that includes depth through the vessel wall can be created to
identify the presence of nerve tissue.
[0060] In some embodiments, the sensor elements 112b can also
measure temperature and detect temperature changes. Ultrasonic
signals generated in the tissue are a function of the material
properties of the tissue. Pertinent properties are the speed of
sound through the material, which changes with temperature, and the
thermal expansion of the material with temperature. These
properties change as temperature changes and affect, in a
predictable manner, the ultrasonic waves generated by the tissue.
The signal processor 110 can therefore be configured to measure
temperature deep in the tissue and/or detect temperature changes in
the tissue. Such measurements may be useful in temperature
dependent nerve modulation techniques to determine the temperatures
at locations and the amount of time the tissue at those locations
is exposed to particular temperatures.
[0061] A dye that preferentially attaches to nerve tissue or to
molecules found in higher concentrations in nerve tissue may be
used in conjunction with the sensing elements 112. The dye may have
a high-optical absorption coefficient at a predetermined frequency
and the sensing elements 112a may emit coherent light at that
frequency. In this manner, the sensitivity of the system to the dye
and the corresponding nerve tissue may be heightened resulting in
more effective or deeper imaging of the nerve tissue. Such a dye
may be injected by a separate needle into the area of interest
prior to introduction of the catheter into the patient's body, may
be introduced through a lumen of the catheter into the body vessel
or may be introduced through another suitable manner such as
topically or orally. Other focusing elements such as those
described in commonly owned U.S. Patent Application Ser. No.
61/324,164 and/or U.S. Patent Application Publication No. US
2011/0257523, the entire disclosures of which are herein
incorporated by reference, may be used with either sensing elements
112a, 112b or, as described below, with ablation elements 114.
[0062] The inner module 124 also includes ablation elements 114.
Preferably, ablation elements that can ablate at depth without
disrupting intervening tissue are used. Such ablation elements may
include laser ablation elements and ultrasonic ablation elements.
In some embodiments, sensing elements 112a or 112b can also
function as the ablation elements. However, other ablation
elements, such as radiofrequency ablation elements or cryogenic
ablation elements may also be used. In the embodiment shown in FIG.
2, ablation elements 114 are ultrasonic ablation elements and are
in the form of a phased array, which allows the ablation element to
target the tissue at a selected depth of focus and may also allow
the focal point to be moved laterally.
[0063] In use, the catheter may be deployed percutaneously or
intravascularly to a region of interest, and the balloon 102 may be
expanded to fix the distal end of the catheter in place during the
procedure. The balloon may preferably be expanded using a clear
inflation fluid such as saline. Sensing elements 112a/112b may then
be activated to create an image of the region of interest
preferentially identifying the nerve tissue. In renal arteries, for
example, nerve tissue generally lies at depths of between 2 and 8
mm. The inner module 124 may be rotated during imaging to create an
image of the body vessel on all sides of the balloon to identify
nerve tissue in the region proximate the balloon. Once the nerve
tissue is identified, the inner module may be rotated to aim the
ablation elements 114 at the nerve tissue. The nerve tissue may
then be ablated by activating the ablation elements 114. The
ablation elements 114 may be focused to ablate only the targeted
nerve tissue.
[0064] FIG. 3A illustrates the distal portion of an example
catheter 200 in a body vessel lumen. Catheter 200 includes a
balloon 102 and a module 124. The module 124 may be rotatable using
actuation element 126. Module 124 includes ultrasonic phased arrays
130 and light emitting element 132. Light emitting element 132
emits short pulses of light 134, which are selected to
preferentially excite nerve tissue 136. Any nerve tissue 136
thereby emits acoustic waves 138, which can be picked up by
ultrasonic arrays 130. The module may be rotated during this
process to identify nerve tissue in the area of interest. As
illustrated in FIG. 3B, once nerve tissue has been identified, the
ultrasonic arrays can then focus ablation energy 140 to a focal
point 142 to ablate the nerve tissue 136. The module 124 can be
rotated to ablate additional nerve tissue. The depth of field of
the focal point may be modified altered, depending on the depth and
location of the nerve tissue.
[0065] Those skilled in the art will recognize that the present
invention may be manifested in a variety of forms other than the
specific embodiments described and contemplated herein.
Accordingly, departure in form and detail may be made without
departing from the scope and spirit of the present invention as
described in the appended claims.
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