U.S. patent application number 16/120713 was filed with the patent office on 2019-03-21 for systems, devices, and methods for ovarian denervation.
The applicant listed for this patent is COVIDIEN LP. Invention is credited to Mirielle K. AKILIAN, Nikolai D. BEGG, Chad A. PICKERING, Dale E. WHIPPLE.
Application Number | 20190083775 16/120713 |
Document ID | / |
Family ID | 65720952 |
Filed Date | 2019-03-21 |
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United States Patent
Application |
20190083775 |
Kind Code |
A1 |
WHIPPLE; Dale E. ; et
al. |
March 21, 2019 |
SYSTEMS, DEVICES, AND METHODS FOR OVARIAN DENERVATION
Abstract
Methods for effectuating ovarian denervation include advancing a
disruptor intravaginally to access an ovarian nerve and applying
the disruptor to the ovarian nerve to denervate the ovarian nerve
to limit ovarian sympathetic neural activity and control hormonal
secretion.
Inventors: |
WHIPPLE; Dale E.; (Nashua,
NH) ; AKILIAN; Mirielle K.; (CANDIA, NH) ;
BEGG; Nikolai D.; (Wayland, MA) ; PICKERING; Chad
A.; (Woburn, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
COVIDIEN LP |
Mansfield |
MA |
US |
|
|
Family ID: |
65720952 |
Appl. No.: |
16/120713 |
Filed: |
September 4, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62561601 |
Sep 21, 2017 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 18/1492 20130101;
A61N 1/36062 20170801; A61B 2017/320008 20130101; A61M 2205/3368
20130101; A61N 2007/003 20130101; A61B 2017/22051 20130101; A61B
2018/00404 20130101; A61N 1/0524 20130101; A61B 17/32 20130101;
A61B 2018/00577 20130101; A61B 2017/320069 20170801; A61N 5/022
20130101; A61B 17/22012 20130101; A61B 18/14 20130101; A61N 7/022
20130101; A61B 2018/00559 20130101; A61M 2205/3375 20130101; A61B
18/24 20130101; A61B 8/12 20130101; A61B 2090/3784 20160201; A61B
18/042 20130101; A61B 18/0206 20130101; A61B 17/320068 20130101;
A61B 18/1485 20130101; A61B 2018/1861 20130101; A61N 1/36103
20130101; A61M 29/02 20130101; A61N 1/36057 20130101; A61B
2018/0212 20130101; A61B 17/32002 20130101; A61B 18/1815 20130101;
A61B 2018/00434 20130101; A61B 17/42 20130101; A61M 2210/1408
20130101; A61N 1/0521 20130101; A61N 1/44 20130101 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61B 18/02 20060101 A61B018/02; A61B 18/14 20060101
A61B018/14 |
Claims
1. A method for effectuating ovarian denervation, the method
comprising: advancing a disruptor intravaginally and through a
vaginal fornix to access a position adjacent an ovarian nerve; and
activating the disruptor to denervate the ovarian nerve.
2. The method of claim 1, wherein the disruptor includes an
ablation device, and wherein advancing the disruptor through the
vaginal fornix includes advancing the ablation device through the
vaginal fornix.
3. The method of claim 2, wherein applying the disruptor includes
ablating the ovarian nerve with the ablation device.
4. The method of claim 1, further comprising advancing an
ultrasound probe intravaginally and positioning the ultrasound
probe to enable the ultrasound probe to project ultrasound in
alignment with an ovary while the disrupter is activated.
5. The method of claim 4, wherein the disrupter is coupled to the
ultrasound probe, and the disruptor and the ultrasound probe are
introduced intravaginally together.
6. The method of claim 5, further comprising advancing the
disruptor relative to the ultrasound probe.
7. The method of claim 6, wherein a guide tube is coupled to the
ultrasound probe, and wherein advancing the disruptor relative to
the ultrasound probe includes advancing the disruptor through the
guide tube.
8. The method of claim 7, wherein advancing the disruptor through
the guide tube includes directing the disruptor away from the
ultrasound probe as the disruptor is advanced relative to the
ultrasound probe.
9. The method of claim 8, wherein directing the disruptor away from
the ultrasound probe includes intravaginally positioning the guide
tube such that the guide tube directs the disruptor toward the
vaginal fornix.
10. The method of claim 1, wherein activating the disruptor
disrupts a myelin sheath of the ovarian nerve without disrupting a
nerve fiber of the ovarian nerve.
11. The method of claim 1, wherein activating the disruptor
includes applying microwave energy to the ovarian nerve.
12. The method of claim 1, wherein activating the disruptor
includes applying electrosurgical plasma to the ovarian nerve.
13. The method of claim 1, wherein activating the disruptor
includes applying a blade to the ovarian nerve.
14. An ovarian denervation system, comprising: an intravaginal
ultrasound probe; a guide tube coupled to the intravaginal
ultrasound probe; and a disruptor advanceable through the guide
tube and relative to the intravaginal ultrasound probe, the
disruptor configured to advance through a vaginal fornix to access
a position adjacent an ovarian nerve, the disruptor configured to
denervate the ovarian nerve.
15. The ovarian denervation system of claim 14, wherein the
disruptor includes an end effector that is configured to ablate the
ovarian nerve with microwave energy.
16. The ovarian denervation system of claim 14, wherein the
disruptor includes an end effector that is configured to emit
electrosurgical plasma for disrupting the ovarian nerve.
17. The ovarian denervation system of claim 14, wherein the
disruptor includes a blade that is configured to scrape the ovarian
nerve.
18. The ovarian denervation system of claim 14, wherein the guide
tube includes a curved distal portion configured to direct the
disruptor toward the vaginal fornix.
19. The ovarian denervation system of claim 14, wherein the
disruptor is configured to disrupt a myelin sheath of the ovarian
nerve without disrupting a nerve fiber of the ovarian nerve.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 62/561,601, filed Sep. 21, 2017, the entire
contents of which are incorporated by reference herein.
TECHNICAL FIELD
[0002] The present disclosure relates to ovarian denervation and,
more particularly, to systems, devices, and methods for disrupting
ovarian nerve supply to limit ovarian sympathetic neural activity
and control hormonal secretion.
BACKGROUND
[0003] Ovarian sympathetic neural activity can cause or exacerbate
several ovarian conditions, including common endocrine disorders
affecting women of reproductive ages (e.g., 12-45 years old) such
as Polycystic Ovary Syndrome (PCOS) and Premenstrual Dysphoric
Disorder (PMDD). Scientific literature suggests that ovarian
hormonal secretion is regulated by sympathetic nervous activity to
the ovary. The sympathetic nervous system (SNS) is a primarily
involuntary bodily control system typically associated with stress
responses. Fibers of the SNS extend through tissue in almost every
organ system of the human body. For example, some fibers extend
from the brain, intertwine along the aorta, and branch out to
various organs. As groups of fibers approach specific organs,
fibers particular to the organs can separate from the groups.
Signals sent via these and other fibers can affect characteristics
such as pupil diameter, gut motility, and urinary output. Such
regulation can have adaptive utility in maintaining homeostasis or
in preparing the body for rapid response to environmental factors.
Chronic activation of the SNS, however, is a common maladaptive
response that can drive the progression of many disease states.
Excessive activation of the ovarian SNS has been identified
experimentally and in humans as a likely contributor to the complex
pathophysiology of PCOS.
SUMMARY
[0004] In accordance with an aspect of the present disclosure, a
method for effectuating ovarian denervation includes advancing a
disruptor intravaginally and through a vaginal fornix to access a
position adjacent an ovarian nerve. The method includes activating
the disruptor to denervate the ovarian nerve.
[0005] The disruptor may include an ablation device, and advancing
the disruptor through the vaginal fornix may include advancing the
ablation device through the vaginal fornix. Activating the
disruptor may include ablating the ovarian nerve with the ablation
device.
[0006] In certain aspects of the present disclosure, the method may
further include advancing an ultrasound probe intravaginally and
positioning the ultrasound probe to enable the ultrasound probe to
project ultrasound in alignment with an ovary while the disrupter
is activated. The disrupter may be coupled to the ultrasound probe,
and the disruptor and the ultrasound probe may be introduced
intravaginally together. The method may further include advancing
the disruptor relative to the ultrasound probe. A guide tube may be
coupled to the ultrasound probe; and advancing the disruptor
relative to the ultrasound probe may include advancing the
disruptor through the guide tube. Advancing the disruptor through
the guide tube may include directing the disruptor away from the
ultrasound probe as the disruptor is advanced relative to the
ultrasound probe. Directing the disruptor away from the ultrasound
probe may include intravaginally positioning the guide tube such
that the guide tube directs the disruptor toward the vaginal
fornix.
[0007] In some aspects of the present disclosure, activating the
disruptor may disrupt a myelin sheath of the ovarian nerve without
disrupting a nerve fiber of the ovarian nerve.
[0008] In certain aspects of the present disclosure, activating the
disruptor may include applying microwave energy to the ovarian
nerve.
[0009] In aspects of the present disclosure, activating the
disruptor may include applying electrosurgical plasma to the
ovarian nerve.
[0010] In some aspects of the present disclosure, activating the
disruptor may include applying a blade to the ovarian nerve.
[0011] According to yet another aspect of the present disclosure,
an ovarian denervation system is provided. The ovarian denervation
system includes an intravaginal ultrasound probe, a guide tube
coupled to the intravaginal ultrasound probe, and a disruptor. The
disruptor is advanceable through the guide tube and relative to the
intravaginal ultrasound probe. The disruptor is configured to
advance through a vaginal fornix to access a position adjacent an
ovarian nerve. The disruptor is configured to denervate the ovarian
nerve.
[0012] In some embodiments of the present disclosure, the disruptor
may include an end effector that is configured to ablate the
ovarian nerve with microwave energy.
[0013] In certain embodiments of the present disclosure, the
disruptor may include an end effector that is configured to emit
electrosurgical plasma for disrupting the ovarian nerve.
[0014] In embodiments of the present disclosure, the disruptor may
include a blade that may be configured to scrape the ovarian
nerve.
[0015] In some embodiments of the present disclosure, the guide
tube includes a curved distal portion configured to direct the
disruptor toward the vaginal fornix.
[0016] In certain embodiments, the disruptor may be configured to
disrupt a myelin sheath of a first ovarian nerve without disrupting
a nerve fiber of the first ovarian nerve.
[0017] According to still another aspect of the present disclosure,
a method for effectuating ovarian denervation includes advancing a
disruptor intravaginally and through a fundus of a uterus to a
position adjacent an ovarian nerve, and activating the disruptor to
denervate the ovarian nerve.
[0018] In aspects of the present disclosure, the disruptor may
include an ablation device, and advancing the disruptor through the
fundus includes advancing the ablation device through the
fundus.
[0019] In some aspects of the present disclosure, the method
includes advancing an ultrasound probe intravaginally and
positioning the ultrasound probe to project ultrasound in alignment
with an ovary while the disrupter is activated. The disrupter may
be coupled to the ultrasound probe, and the disruptor and the
ultrasound probe may be introduced intravaginally together. The
method may further include advancing the disruptor relative to the
ultrasound probe. A guide tube may be coupled to the ultrasound
probe; and advancing the disruptor relative to the ultrasound probe
may include advancing the disruptor through the guide tube.
Advancing the disruptor through the guide tube may include
directing the disruptor away from the ultrasound probe as the
disruptor is advanced relative to the ultrasound probe. Directing
the disruptor away from the ultrasound probe may include
intravaginally positioning the guide tube such that the guide tube
directs the disruptor toward the fundus.
[0020] According to yet another aspect of the present disclosure,
an ovarian denervation system includes an intravaginal ultrasound
probe, a guide tube coupled to the intravaginal ultrasound probe,
and a disruptor. The disruptor is advanceable through the guide
tube and relative to the intravaginal ultrasound probe. The
disruptor is configured to advance through a a fundus of a uterus
to a position adjacent an ovarian nerve. The disruptor is
configured to denervate the ovarian nerve.
[0021] In some embodiments of the present disclosure, the guide
tube may include a curved distal portion configured to direct the
disruptor toward the fundus.
[0022] According to still another aspect of the present disclosure,
a method for effectuating ovarian denervation includes advancing a
disruptor intravaginally and into a fallopian tube to access an
ovarian nerve, and activating the disruptor to denervate the
ovarian nerve.
[0023] In some aspects of the present disclosure, the disruptor may
include an ablation device, and advancing the disruptor through the
fallopian tube may include advancing the ablation device through
the fallopian tube.
[0024] In certain aspects of the present disclosure, the method may
further include advancing the disruptor to a position adjacent to
an infundibulopelvic ligament.
[0025] In aspects of the present disclosure, the method may further
include advancing an ultrasound probe intravaginally, and
positioning the ultrasound probe to project ultrasound in alignment
with an ovary while the disrupter is activated. The method may
further include advancing the disruptor relative to the ultrasound
probe. A guide tube may be coupled to the ultrasound probe, and
advancing the disruptor relative to the ultrasound probe may
include advancing the disruptor through the guide tube. Advancing
the disruptor through the guide tube may include directing the
disruptor away from the ultrasound probe as the disruptor is
advanced relative to the ultrasound probe. Directing the disruptor
away from the ultrasound probe may include intravaginally
positioning the guide tube such that the guide tube directs the
disruptor toward the uterus.
[0026] According to yet another aspect of the present disclosure,
an ovarian denervation system includes an intravaginal ultrasound
probe, a guide tube coupled to the intravaginal ultrasound probe,
and a disruptor. The disruptor is advanceable through the guide
tube and relative to the intravaginal ultrasound probe. The
disruptor is configured to advance into a fallopian tube to a
position adjacent an ovarian nerve. The disruptor is configured to
denervate the ovarian nerve.
[0027] In some embodiments, the guide tube includes a curved distal
portion configured to direct the disruptor toward the fallopian
tube.
[0028] According to still another aspect of the present disclosure,
a method for effectuating ovarian denervation includes introducing
a catheter into an ovarian vessel, and expanding a balloon within
the ovarian vessel to disrupt an ovarian nerve that extends along
the ovarian vessel without tearing a wall of the ovarian
vessel.
[0029] The method may further include positioning the balloon
adjacent an infundibulopelvic ligament that supports the ovarian
vessel.
[0030] In some aspects of the present disclosure, expanding the
balloon may include inflating the balloon with inflation fluid.
[0031] In certain aspects of the present disclosure, the method may
include deflating the balloon and positioning the balloon within a
second ovarian vessel for re-inflation. The method may further
include re-inflating the balloon within the second ovarian vessel
to disrupt a second ovarian nerve that extends along the second
ovarian vessel without tearing a wall of the second ovarian
vessel.
[0032] In some aspects of the present disclosure, expanding the
balloon may include tearing the ovarian nerve that extends along
the ovarian vessel without tearing the wall of the ovarian
vessel.
[0033] According to still another aspect of the present disclosure,
a method for effectuating ovarian denervation includes implanting
one or more electrodes within an ovarian vessel, and activating the
one or more electrodes to disrupt an ovarian nerve.
[0034] In some aspects of the present disclosure, the method may
further include implanting one or more additional electrodes
adjacent to the ovarian vessel. The method may include activating
the one or more additional electrodes to disrupt an ovarian nerve.
Activating the one or more additional electrodes may include
intermittently conducting electrical energy through the one or more
additional electrodes. Implanting the one or more additional
electrodes may include implanting the one or more additional
electrodes adjacent to an infundibulopelvic ligament.
[0035] In certain aspects, implanting the one or more electrodes
may include implanting the one or more electrodes within an
infundibulopelvic ligament. Activating the one or more electrodes
may include intermittently conducting electrical energy through the
one or more electrodes.
[0036] According to yet another aspect of the present disclosure, a
method for effectuating ovarian denervation includes implanting one
or more electrodes adjacent to an ovarian vessel, and activating
the one or more electrodes to disrupt an ovarian nerve.
[0037] In some aspects of the present disclosure, implanting the
one or more electrodes includes implanting the one or more
electrodes adjacent to an infundibulopelvic ligament.
[0038] Other aspects, features, and advantages will be apparent
from the description, the drawings, and the claims that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the present systems, devices, and methods for disrupting an ovarian
nerve and, together with a general description of the disclosure
given above, and the detailed description given below, serve to
explain the principles of the disclosure, wherein:
[0040] FIGS. 1A and 1B are anatomical views illustrating vaginal
tissue.
[0041] FIG. 1C is an anatomical view illustrating an ovarian artery
and nearby organs and vessels.
[0042] FIG. 1D is a partial, cross-sectional view illustrating an
ovarian denervation technique in accordance with one aspect of the
present disclosure.
[0043] FIG. 2 is a conceptual illustration of a sympathetic nervous
system (SNS) and how a brain communicates with a body via the
SNS.
[0044] FIG. 3 is an enlarged anatomic view of arterial vasculature
anatomy of an ovary.
[0045] FIG. 4 is a side view of an ovarian denervation system in
accordance with an illustrative embodiment of the present
disclosure.
[0046] FIG. 5A is an anatomical view of vaginal tissue including
illustrations of projected trajectories of components of the
ovarian denervation system of FIG. 4 in accordance with an aspect
of an ovarian denervation technique of the present disclosure.
[0047] FIG. 5B is a schematic view illustrating an aspect of the
ovarian denervation technique of FIG. 5A.
[0048] FIGS. 6-10 are views illustrating different ovarian
denervation techniques in accordance with various aspects of the
present disclosure.
[0049] FIGS. 11A and 11B are progressive views illustrating an
ovarian denervation technique involving a balloon catheter in
accordance with an aspect of the present disclosure.
[0050] FIG. 12A-12B are anatomical views of nerve fiber and its
myelin sheath in a normal state.
[0051] FIG. 12C is an anatomical view of the nerve fiber and its
myelin sheath in a disrupted state.
DETAILED DESCRIPTION
[0052] A need exists to provide systems, devices, and/or methods
for disrupting nerve supply to an ovary.
[0053] Although the presently disclosed systems, devices, methods
are described herein with respect to ovarian denervation, these
systems, devices, and/or methods may be modified for disrupting the
nerve supply to other organs or body systems or to treat other
diseases or conditions.
[0054] Embodiments of the presently disclosed systems, devices,
and/or methods for disrupting ovarian nerve supply are described in
detail with reference to the drawings, in which like reference
numerals designate identical or corresponding elements in each of
the several views. As used herein, the term "distal" refers to that
portion of structure farther from the user, while the term
"proximal" refers to that portion of structure, closer to the user.
As used herein, the term "clinician" refers to a doctor, nurse, or
other care provider and may include support personnel. As used
herein, the terms "denervation," "disruption" or other similar
terms refer to any loss in, or damage to, nerve supply including
partial or complete loss of, or damage to, nerve supply.
[0055] In the following description, well-known functions or
constructions are not described in detail to avoid obscuring the
present disclosure in unnecessary detail.
[0056] The vaginal anatomy is generally illustrated in FIGS. 1A-1D.
FIG. 1C, in particular, is an anatomical view illustrating the
ovaries 10 and nearby organs and vessels, including an ovarian
artery 12. Treatment procedures for ovarian denervations or
disruptions, in accordance with embodiments of the present
technology, can include applying a treatment modality at one or
more treatment locations proximate a structure having a relatively
high concentration of ovarian nerves. In some aspects, for example,
at least one treatment location can be proximate a portion of the
ovarian artery 12, a branch of the ovarian artery 12, an ostium of
the ovarian artery 12, an ovarian vein 14, a branch of an ovarian
vein, an ostium of an ovarian vein, and/or another suitable
structure (e.g., another suitable structure extending along the
suspensory ligament) in the vicinity of ovarian nerves.
[0057] FIG. 1D is a cross-sectional view illustrating denervation
at a treatment location within the ovarian artery 12. As shown in
FIG. 1D, a treatment device 16 including a shaft 18 and an end
effector 20 supported thereon, can be extended toward the ovarian
artery 12 to locate the end effector 20 at the treatment location
within the ovarian artery 12. The end effector 20 can be configured
for denervation at the treatment location via a suitable treatment
modality, e.g., direct heat, electrode-based, microwave, light,
ultrasonic, or another suitable treatment modality.
[0058] With continued reference to FIGS. 1A-1D, the treatment
location can be proximate (e.g., at or near) a vessel or chamber
wall (e.g., a wall of an ovarian artery, an ovarian vein, and/or
another suitable structure), and the treated tissue can include
tissue proximate the treatment location. For example, with regard
to the ovarian artery 12, a treatment procedure can include
ablating nerves in the ovarian plexus, which lay at least partially
within or adjacent to the adventitia of the ovarian artery. In some
embodiments, it may be desirable to disrupt ovarian nerves from a
treatment location within a tubular structure or vessel and in
close proximity to an ovary, e.g., closer to the ovary 10 than to a
trunk of the vessel. This can increase the likelihood of disrupting
nerves specific to the ovary, while decreasing the likelihood of
disrupting nerves that extend to other organs. Vessels can decrease
in diameter and become more tortuous as they extend toward an ovary
10. Accordingly, disrupting ovarian nerves from a treatment
location in close proximity to an ovary can include using a device
(e.g., treatment device 16) having size, flexibility,
torque-ability, kink resistance, and/or other characteristics
suitable for accessing narrow and/or tortuous portions of
vessels.
[0059] Energy delivery techniques, such as an electrode-based
approach, for example, can be used for ovarian denervation.
Electrode-based treatment can include delivering electrical energy
and/or another form of energy to tissue and/or heating tissue at a
treatment location in a manner that disrupts neural function. For
example, sufficiently disrupting at least a portion of a
sympathetic ovarian nerve can slow or potentially block conduction
of neural signals to produce a prolonged or permanent reduction in
sympathetic activity. Some suitable energy modalities can include,
for example, RF energy (monopolar and/or bipolar), pulsed RF
energy, microwave energy, ultrasound energy (e.g., intravascularly
delivered ultrasound, extracorporeal ultrasound, HIFU), laser
energy, optical energy, magnetic energy, direct heat, or other
suitable energy modalities alone or in combination. Where a system
uses a monopolar configuration, a return electrode or ground patch
fixed externally on the subject can be used. Moreover, electrodes
(or other energy delivery elements) can be used alone or with other
electrodes in a multi-electrode array. Examples of suitable
multi-electrode devices are described in U.S. Patent Application
Publication No. 2012/0116382, and incorporated herein by reference
in its entirety. Other suitable devices and technologies, such as
thermal devices, are described in U.S. Patent Application
Publication No. 2012/0136350, also incorporated herein by reference
in its entirety.
[0060] Thermal effects can include both thermal ablation and
non-ablative thermal alteration or damage (e.g., via sustained
heating and/or resistive heating) to partially or completely
disrupt the ability of a nerve to transmit a signal. Desired
thermal heating effects, for example, may include raising the
temperature of target neural fibers above a desired threshold to
achieve non-ablative thermal alteration, or above a higher
temperature to achieve ablative thermal alteration. For example,
the target temperature can be above body temperature (e.g.,
approximately 37.degree. C.), but less than about 45.degree. C. for
non-ablative thermal alteration, or the target temperature can be
about 45.degree. C. or higher kw ablative thermal alteration. More
specifically, exposure to thermal energy in excess of a body
temperature of about 37.degree. C., but below a temperature of
about 45.degree. C., may induce thermal alteration via moderate
heating of target neural fibers or of vascular structures that
perfuse the target fibers. In cases where vascular structures are
affected, the target neural fibers may be denied perfusion
resulting in necrosis of the neural tissue. For instance, this may
induce non-ablative thermal alteration in the fibers or structures.
Exposure to heat above a temperature of about 45.degree. C., or
above about 60.degree. C., may induce thermal alteration via
substantial heating of the fibers or structures. For example, such
higher temperatures may thermally ablate the target neural fibers
or the vascular structures that perfuse the target fibers. In some
patients, it may be desirable to achieve temperatures that
thermally ablate the target neural fibers or the vascular
structures, but that are less than about 90.degree. C., or less
than about 85.degree. C., or less than about 80.degree. C., and/or
less than about 75.degree. C. Other aspects can include heating
tissue to a variety of other suitable temperatures.
[0061] In some aspects of the present disclosure, a treatment
procedure can include applying a suitable treatment modality at a
treatment location in a testing step followed by a treatment step.
The testing step, for example, can include applying the treatment
modality at a lower intensity and/or fix a shorter duration than
during the treatment step. This can allow an operator to determine
(e.g., by neural activity sensors and/or patient feedback) whether
nerves proximate the treatment location are suitable for
denervation. Performing a testing step can be particularly useful
for treatment procedures in which targeted nerves are closely
associated with nerves that could cause undesirable side effects if
disrupted during a subsequent treatment step.
[0062] In accordance with the present technology, denervation of a
left and/or right ovarian nerve (e.g., ovarian plexus), which is
intimately associated with a left and/or right ovarian artery 12
(FIG. 1C), may be achieved through intravascular access.
[0063] The following discussion provides further details regarding
pertinent patient anatomy and physiology. This section is intended
to supplement and expand upon the previous discussion regarding the
relevant anatomy and physiology, and to provide additional context
regarding the disclosed technology and the benefits associated with
ovarian denervation.
[0064] With reference to FIG. 2, the sympathetic nervous system
(SNS) is a branch of the autonomic nervous system along with the
enteric nervous system and parasympathetic nervous system. It is
always active at a basal level (called sympathetic tone) and
becomes more active during times of stress. Like other parts of the
nervous system, the SNS operates through a series of interconnected
neurons. Sympathetic neurons are frequently considered part of the
peripheral nervous system (PNS), although many lie within the
central nervous system (CNS). Sympathetic neurons of the spinal
cord (which is part of the CNS) communicate with peripheral
sympathetic neurons via a series of sympathetic ganglia. Within the
ganglia, spinal cord sympathetic neurons join peripheral
sympathetic neurons through synapses. Spinal cord sympathetic
neurons are therefore called presynaptic (or preganglionic)
neurons, while peripheral sympathetic neurons are called
postsynaptic (or postganglionic) neurons.
[0065] At synapses within the sympathetic ganglia, preganglionic
sympathetic neurons release acetylcholine, a chemical messenger
that binds and activates nicotinic acetylcholine receptors on
postganglionic neurons. In response to this stimulus,
postganglionic neurons principally release noradrenaline
(norepinephrine). Prolonged activation may elicit the release of
adrenaline from the adrenal medulla.
[0066] Once released, norepinephrine binds adrenergic receptors on
peripheral tissues. Binding to adrenergic receptors causes a
neuronal and hormonal response. The physiologic manifestations
include pupil dilation, increased heart rate, occasional vomiting,
and increased blood pressure. Increased sweating is also seen due
to binding of cholinergic receptors of the sweat glands.
[0067] The SNS is responsible for up- and down-regulation of many
homeostatic mechanisms in living organisms. Fibers from the SNS
innervate tissues in almost every organ system, providing at least
some regulatory function to physiological features as diverse as
pupil diameter, gut motility, and urinary output. This response is
also known as the sympatho-adrenal response of the body, as the
preganglionic sympathetic fibers that end in the adrenal medulla
(but also all other sympathetic fibers) secrete acetylcholine,
which activates the secretion of adrenaline (epinephrine) and to a
lesser extent noradrenaline (norepinephrine). Therefore, this
response that acts primarily on the cardiovascular system is
mediated directly via impulses transmitted through the SNS and
indirectly via catecholamines secreted from the adrenal
medulla.
[0068] Science typically looks at the SNS as an automatic
regulation system, that is, one that operates without the
intervention of conscious thought. Some evolutionary theorists
suggest that the SNS operated in early organisms to maintain
survival as the SNS is responsible for priming the body for action.
One example of this priming is in the moments before waking, in
which sympathetic outflow spontaneously increases in preparation
for action.
[0069] The Sympathetic Chain
[0070] As shown in FIG. 2, the SNS provides a network of nerves
that allows the brain to communicate with the body. Sympathetic
nerves originate inside the vertebral column, toward the middle of
the spinal cord in the intermediolateral cell column (or lateral
horn), beginning at the first thoracic segment of the spinal cord
and are thought to extend to the second or third lumbar segments.
Because its cells begin in the thoracic and lumbar regions of the
spinal cord, the SNS is said to have a thoracolumbar outflow. Axons
of these nerves leave the spinal cord through the anterior
rootlet/root. They pass near the spinal (sensory) ganglion, where
they enter the anterior rami of the spinal nerves. However, unlike
somatic innervation, they quickly separate out through white rami
connectors that connect to either the paravertebral (which lie near
the vertebral column) or prevertebral (which lie near the aortic
bifurcation) ganglia extending alongside the spinal column.
[0071] In order to reach the target organs and glands, the axons
travel long distances in the body. Many axons relay their message
to a second cell through synaptic transmission. The first cell (the
presynaptic cell) sends a neurotransmitter across the synaptic
cleft (the space between the axon terminal of the first cell and
the dendrite of the second cell) where it activates the second cell
(the postsynaptic cell). The message is then propagated to the
final destination.
[0072] In the SNS and other neuronal networks of the peripheral
nervous system, these synapses are located at sites called ganglia,
discussed above. The cell that sends its fiber to a ganglion is
called a preganglionic cell, while the cell whose fiber leaves the
ganglion is called a postganglionic cell. As mentioned previously,
the preganglionic cells of the SNS are located between the first
thoracic (T1) segment and third lumbar (L3) segments of the spinal
cord. Postganglionic cells have their cell bodies in the ganglia
and send their axons to target organs or glands. The ganglia
include not just the sympathetic trunks but also the cervical
ganglia (superior, middle and inferior), which sends sympathetic
nerve fibers to the head and thorax organs, and the celiac and
mesenteric ganglia (which send sympathetic fibers to the gut).
[0073] Innervation of the Ovaries
[0074] The ovaries and part of the fallopian tubes and broad
ligament of the uterus are innervated by the ovarian plexus, a
network of nerve fibers accompanying the ovarian vessels and
derived from the aortic and renal plexuses. As FIG. 3 shows, the
blood supply to the ovary is provided by the ovarian artery. The
ovarian plexus is an autonomic plexus that surrounds the ovarian
artery and is carried in the suspensory ligament. The ovarian
plexus extends along the ovarian artery until it arrives at the
substance of the ovary. Fibers contributing to the ovarian plexus
arise from the renal plexus, celiac ganglion, the superior
mesenteric ganglion, the aorticorenal ganglion and the aortic
plexus. The ovarian plexus, also referred to as the ovarian nerve,
is predominantly comprised of sympathetic nerve fibers.
[0075] Preganglionic neuronal cell bodies are located in the
intermediolateral cell column of the spinal cord. Preganglionic
axons pass through the paravertebral ganglia (they do not synapse)
to become the lesser splanchnic nerve, the least splanchnic nerve,
the first lumbar splanchnic nerve, and the second lumbar splanchnic
nerve, and they travel to the celiac ganglion, the superior
mesenteric ganglion, and the aorticorenal ganglion. Postganglionic
neuronal cell bodies exit the celiac ganglion, the superior
mesenteric ganglion, and the aorticorenal ganglion to the renal
plexus, which are distributed to the renal vasculature, and give
rise to the ovarian plexus which is distributed to the ovary and
the fundus of the uterus.
[0076] Ovarian Sympathetic Neural Activity
[0077] Messages trawl through the SNS in a bidirectional flow.
Efferent messages may trigger changes in different parts of the
body simultaneously. For example, the SNS may accelerate heart
rate; widen bronchial passages; decrease motility (movement) of the
large intestine; constrict blood vessels; increase peristalsis in
the esophagus; cause pupil dilation, cause piloerection (i.e.,
goose bumps), cause perspiration (i.e., sweating), and raise blood
pressure. Afferent messages carry signals from various organs and
sensory receptors in the body to other organs and, particularly,
the brain.
[0078] Hypertension, heart failure and chronic kidney disease are a
few of many disease states that result from chronic activation of
the SNS, especially the renal sympathetic nervous system. Chronic
activation of the SNS is a maladaptive response that drives the
progression of these disease states. Pharmaceutical management of
the renin-angiotensin-aldosterone system (RAM) has been a
longstanding, but somewhat ineffective, approach for reducing
overactivity of the SNS.
[0079] For a more detailed description of pertinent patient anatomy
and physiology, reference may be made to U.S. Patent Application
Publication No. 2015/0051594, filed Mar. 7, 2013, the entire
contents of which are incorporated herein by reference.
[0080] The presently disclosed systems, devices, and
methods/techniques disrupt the nervous supply to the ovaries in
order to control (e.g., down-regulate) ovarian hormonal secretion
and treat hormonally-regulated diseases such as POCS and PMDD. By
disrupting the ovarian nerve supply, hormonal overproduction
leading to disease states may be effectively treated.
[0081] Turning now to FIGS. 4, 5A, and 5B, an ovary denervation
system 100, in accordance with one embodiment of the present
disclosure, includes a guide tube 102 secured to a transvaginal
ultrasound probe 104, and a disruptor 106 (e.g., an ablation
device) that is selectively advanceable relative to guide tube 102
(e.g., therethrough). Guide tube 102 is positioned to guide
disruptor 106 toward the ovary so that disruptor 106 is maintained
in alignment with a plane "P" of ultrasound projected from
transvaginal ultrasound probe 104. Guide tube 102 may have a curved
distal portion 102a that curves away from transvaginal ultrasound
probe 104 to guide or otherwise direct disruptor 106 toward the
ovary as disruptor 106 is advanced through guide tube 102. Once
disruptor 106 is positioned adjacent to ovarian anatomy, disruptor
106 can be activated to disrupt (e.g., ablate) ovarian nerves. For
a more detailed description of example disruptors, such as
microwave ablation devices, reference can be made to U.S. Pat. No.
9,247,992, U.S. Pat. No. 9,119,650, or U.S. Patent Application
Publication No. 2013/0317495, the entire contents of each of which
are incorporated herein by reference. As used herein, the term
"ablation device" may refer to any device that ablates tissue
through direct application of heat, cooling, electrosurgical
current, ultrasonic vibration, other energy transfer, etc., or
combinations thereof.
[0082] As seen in FIG. 5A, a method for ovarian denervation
includes inserting disruptor 106 into the ovaries and/or
surrounding tissue through the vagina and vaginal fornix (see, for
example, paths "X1" and "X2" illustrating the trans-fornix
approach) under direct ultrasound guidance, for example, from
transvaginal ultrasound probe 104 supported within the vagina.
Transvaginal ultrasound probe 104 can be positioned within the
vagina to project ultrasound through vaginal anatomy toward the
ovary to enable visualization and facilitate positioning of
disruptor 106 relative to ovaries, ovarian nerves, etc. so that
disruptor 106 can be accurately positioned to disrupt the ovarian
nerve supply upon application thereof. This trans-fornix approach
may be similar to the manner in which an oocyte retrieval needle is
placed into the ovary during IVF egg retrieval.
[0083] With reference to FIG. 6, according to another aspect of the
present disclosure, one method for ovarian denervation includes
passing a disruptor (e.g., disruptor 106) along a path or
trajectory "X3" that extends through the cervix and into the
fallopian tubes so as to define a trans-fallopian approach. The
disruptor is advanced to a location "I" where the infundibulopelvic
ligament passes across and adjacent to the respective fallopian
tube. Once the disruptor is in position at location "I," the
disruptor can be applied to effectuate local treatment, for
instance, by ablating ovarian nerves contained within the
infundibulopelvic ligament. To facilitate visualization, any
suitable guidance technique may be utilized to confirm disruption
(e.g., ablation) is occurring at the desired location along the
fallopian tube. For example, such guidance techniques may include
ultrasound (e.g., transvaginal ultrasound probe 104 seen in FIG.
4), fluoroscopy, etc., or combinations thereof.
[0084] With continued reference to FIG. 6, in some aspects of the
present disclosure, one or more of the presently disclosed systems
and/or devices (e.g., the disruptor 106) may be advanced through
(e.g., via piercing, puncturing, etc.) the fundus of the patient's
uterus to access the infundibulopelvic ligament and/or ovarian
nerves thereof, for example, in addition to, and/or instead of,
through the fallopian tubes.
[0085] Turning now to FIG. 7, in one aspect of the present
disclosure, another method for ovarian denervation includes
positioning (temporarily or permanently implanting) disruptors,
such as one or more electrodes 110, 112, within (e.g., electrode
110), and/or adjacent to (e.g., electrode 112), the ovarian artery
for acting on the ovarian nerve supply. Electrodes 110, 112 are
configured to be activated to apply electrical stimulus (e.g.,
electrical energy) to tissues/nerves of the infundibulopelvic
ligament, effectively disrupting the sympathetic nerve signals
transmitted through the ovarian nerves. The implanted electrodes
110, 112 may be configured to apply electrical stimulus
continuously or intermittently. The electrical stimulus may be
modulated, depending on the severity of symptom or phase of the
patient's menstrual cycle. Electrodes 110, 112 may be coupled to an
energy source such as an electrosurgical generator "EG" that
selectively transmits electrical energy to electrodes 110, 112. For
a more detailed description of one example of an electrosurgical
generator, reference can be made to U.S. Pat. No. 8,784,410, the
entire contents of which are incorporated by reference herein.
[0086] With reference to FIG. 8, according to a further aspect of
the present disclosure, one method for ovarian denervation includes
providing an energy source "ES" outside a patient and positioning
the energy source "ES" so as to enable application of focused
energy "E" to the ovary, the tissues surrounding the ovary, and/or
the ovarian vessel (e.g., artery), in order to disrupt the nerve
supply. Any suitable energy application technique may be utilized
and may be applied directly (e.g., such that target site is
externally exposed) or indirectly (e.g., such that the target site
is not externally exposed and energy is required to pass through
other tissue first). For example, the energy source "ES" can be
configured to provide focused ultrasound, focused radiation (e.g.,
gamma-knife), focused microwave energy, light, etc., or
combinations thereof. The energy source "ES" may include a
cyclotron, a linear accelerator, a kilovoltage unit, a teletherapy
unit, etc., or combinations thereof.
[0087] Referring now to FIG. 9, in yet another aspect of the
present disclosure, a method for ovarian denervation includes
applying a beam of electrosurgical plasma "EP," from a disruptor
such as a plasma emitter 200 (e.g., an argon plasma emitter), to a
surface of the infundibulopelvic ligament to ablate the sympathetic
nerves "N" running along the outer surface of the ovarian artery
for denervating the ovarian nerve supply. For a more detailed
description of an example of plasma emitter, reference can be made
to U.S. Pat. No. 6,039,736, the entire contents of which are
incorporated herein by reference.
[0088] According to another aspect of the present disclosure, one
method for ovarian denervation includes applying light at a
controlled frequency (e.g., photoablation with a laser), with a
disruptor such as a light emitting instrument (not shown), to the
tissues of the infundibulopelvic ligament (see FIG. 1A, 9) or to
the tissue surrounding the ovary to ablate ovarian nerve tissue.
For example, photoablation with a laser (e.g. an excimer or exiplex
laser) having a wavelength of approximately 200 nm may be used to
disrupt ovarian nerves. With a controlled frequency of light, more
energy can be absorbed by nerve tissue than by other surrounding
tissue so that the nerves are locally ablated with minimal
surrounding tissue damage.
[0089] Turning now to FIG. 10, in still another aspect of the
present disclosure, one method for ovarian denervation includes
applying a disruptor such as a mechanical resection device (e.g., a
scalpel) or shaver blade 300 to the surface of the ovarian artery
to denervate (e.g., mechanically disrupt and resect) the ovarian
nerves at the outer surface of the ovarian artery (e.g., by cutting
and/or scraping).
[0090] As seen in FIGS. 11A and 11B, in one aspect of the present
disclosure, still another method for ovarian denervation includes
introducing a disruptor, in the form of a balloon catheter 400,
into one or more ovarian vessels within the infundibulopelvic
ligament. A balloon 402 of balloon catheter 400 can be inflated
with inflation fluid (e.g., saline) from an inflation source (not
shown) coupled to balloon catheter 400. In particular, balloon 402
can be selectively inflated within an ovarian vessel to a threshold
volume so that the ovarian vessel wall expands an amount sufficient
to mechanically tear or disrupt one or more nerves running along
the ovarian vessel without causing the wall of the ovarian vessel
to tear. Balloon 402 may then be deflated so that balloon catheter
400 can be withdrawn. Although described with respect to a balloon,
any suitable expandable structure can be utilized (e.g., a stent,
radially extendable prongs, etc.). The expandable structure (e.g.,
balloon 402) may be deflated and/or re-inflated as desired, for
example, to repeat the technique at one or more additional
locations along the vessel or in another vessel. For a more
detailed description of an example of balloon catheter, reference
can be made to U.S. Patent Application Publication No.
2014/0250661, the entire contents of which are incorporated herein
by reference.
[0091] As seen in FIGS. 12A-12C, in certain aspects of the present
disclosure, the myelin sheath surrounding the ovarian nerves may be
disrupted, for example, with the disruptor 106 (or utilizing any of
the other presently disclosed devices, systems, and/or techniques),
to effectuate ovarian denervation.
[0092] Any of the presently disclosed techniques can be effectuated
individually or in any suitable combination.
[0093] The various embodiments/techniques disclosed herein may also
be configured to work with robotic surgical systems and what is
commonly referred to as "Telesurgery." Such systems employ various
robotic elements to assist the clinician and allow remote operation
(or partial remote operation) of surgical instrumentation. Various
robotic arms, gears, cams, pulleys, electric and mechanical motors,
etc. may be employed for this purpose and may be designed with a
robotic surgical system to assist the clinician during the course
of an operation or treatment. Such robotic systems may include
remotely steerable systems, automatically flexible surgical
systems, remotely flexible surgical systems, remotely articulating
surgical systems, wireless surgical systems, modular or selectively
configurable remotely operated surgical systems, etc.
[0094] The robotic surgical systems may be employed with one or
more consoles that are next to the operating theater or located in
a remote location. In this instance, one team of clinicians may
prep the patient for surgery and configure the robotic surgical
system with one or more of the instruments disclosed herein while
another clinician (or group of clinicians) remotely controls the
instruments via the robotic surgical system. As can be appreciated,
a highly skilled clinician may perform multiple operations in
multiple locations without leaving his/her remote console which can
be both economically advantageous and a benefit to the patient or a
series of patients.
[0095] For a detailed description of exemplary medical work
stations and/or components thereof, reference may be made to U.S.
Patent Application Publication No. 2012/0116416, and PCT
Application Publication No. WO2016/025132, the entire contents of
each of which are incorporated by reference herein.
[0096] Persons skilled in the art will understand that the
structures and methods specifically described herein and shown in
the accompanying figures are non-limiting exemplary embodiments,
and that the description, disclosure, and figures should be
construed merely as exemplary of particular embodiments. It is to
be understood, therefore, that the present disclosure is not
limited to the precise embodiments described, and that various
other changes and modifications may be effected by one skilled in
the art without departing from the scope or spirit of the
disclosure. Additionally, the elements and features shown or
described in connection with certain embodiments may be combined
with the elements and features of certain other embodiments without
departing from the scope of the present disclosure, and that such
modifications and variations are also included within the scope of
the present disclosure. Accordingly, the subject matter of the
present disclosure is not limited by what has been particularly
shown and described.
* * * * *