U.S. patent application number 16/825591 was filed with the patent office on 2020-10-15 for hyaline cartilage shaping.
This patent application is currently assigned to Aerin Medical Inc.. The applicant listed for this patent is Aerin Medical Inc.. Invention is credited to Fred DINGER, Andrew FRAZIER.
Application Number | 20200323548 16/825591 |
Document ID | / |
Family ID | 1000004916731 |
Filed Date | 2020-10-15 |
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United States Patent
Application |
20200323548 |
Kind Code |
A1 |
DINGER; Fred ; et
al. |
October 15, 2020 |
HYALINE CARTILAGE SHAPING
Abstract
Disclosed embodiments include devices and methods for shaping,
bending, and/or volumetrically reducing rigid cartilaginous
structures, such as hyaline cartilage in the septum. In the case of
septal cartilage, shaping, bending, or reducing the cartilage would
be useful for reducing nasal obstruction or to improve the cosmetic
appearance of the nose.
Inventors: |
DINGER; Fred; (Austin,
TX) ; FRAZIER; Andrew; (Sunnyvale, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Aerin Medical Inc. |
Sunnyvale |
CA |
US |
|
|
Assignee: |
Aerin Medical Inc.
Sunnyvale
CA
|
Family ID: |
1000004916731 |
Appl. No.: |
16/825591 |
Filed: |
March 20, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15429947 |
Feb 10, 2017 |
10603059 |
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16825591 |
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62294724 |
Feb 12, 2016 |
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62335802 |
May 13, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/248 20130101;
A61B 2018/126 20130101; C12Y 302/01035 20130101; A61B 2018/00327
20130101; A61B 2018/0212 20130101; C12Y 304/21004 20130101; A61B
2018/0022 20130101; A61B 2090/062 20160201; A61B 2018/00875
20130101; A61B 18/1485 20130101; A61B 2017/00407 20130101; A61K
38/47 20130101; A61B 1/0661 20130101; A61B 18/1206 20130101; A61B
2090/3945 20160201; A61B 18/1442 20130101; A61K 9/0043 20130101;
A61B 2017/0088 20130101; A61B 2017/00867 20130101; A61B 2018/046
20130101; A61B 17/24 20130101; C12Y 304/24007 20130101; A61B
2017/00893 20130101; A61B 2018/00642 20130101; A61B 2018/00595
20130101; A61B 5/065 20130101; A61B 17/00491 20130101; A61K 38/4826
20130101; A61B 2018/0016 20130101; A61B 18/1445 20130101; A61B
18/0218 20130101; A61B 2017/00929 20130101; A61B 2018/1253
20130101; A61B 2017/00955 20130101; A61B 18/1402 20130101; A61B
2018/1467 20130101; A61B 2017/320094 20170801; A61B 2018/143
20130101; A61B 2018/00821 20130101; A61B 2090/306 20160201; A61B
2018/00101 20130101 |
International
Class: |
A61B 17/24 20060101
A61B017/24; A61B 18/14 20060101 A61B018/14; A61K 9/00 20060101
A61K009/00; A61K 38/47 20060101 A61K038/47; A61B 5/06 20060101
A61B005/06; A61B 1/06 20060101 A61B001/06; A61B 18/02 20060101
A61B018/02; A61B 18/12 20060101 A61B018/12; A61K 38/48 20060101
A61K038/48 |
Claims
1. A method for modifying a nasal septum of a subject's nose
without forming an incision or removing tissue, the method
comprising: injecting a substance under nasal mucosa and into
contact with cartilage of the nasal septum, wherein the substance
is configured to modify a property of the cartilage, and wherein
the substance is selected from the group consisting of collagenase,
hyaluronidase, tosyl lysyl chloromethane, trypsin, and
trypsin/EDTA; inserting an elongate treatment element of a bipolar
radiofrequency energy delivery device into the subject's nose,
wherein the elongate treatment element comprises two rows of
bipolar electrodes; applying force to the nasal septum with the
elongate treatment element, to change a shape of the cartilage of
the nasal septum; applying radiofrequency energy to the cartilage
of the nasal septum at a selected tissue depth by transmitting the
radiofrequency energy from a first row of the two rows of bipolar
electrodes to a second row of the two rows, while continuing to
apply force to the nasal septum with the elongate treatment
element; and removing the elongate treatment element from the
subject's nose, wherein the shape of the cartilage of the nasal
septum remains changed after the elongate treatment element is
removed.
2. (canceled)
3. The method of claim 1, wherein the substance is configured to
soften the cartilage of the nasal septum.
4. The method of claim 1, wherein the substance is configured to
dissolve proteoglycan structures of the cartilage.
5. The method of claim 1, wherein the substance comprises about 0.5
ml to about 2.5 ml of collagenase at a concentration of about 1
mg/ml to about 10 mg/ml.
6. The method of claim 1, wherein the substance comprises between
about 0.5 ml to about 2.5 ml of trypsin at a concentration of about
10 .mu.g/ml to about 100 .mu.g/ml.
7. The method of claim 1, further comprising allowing the substance
to reside on the nasal septum for a period of time before applying
the radiofrequency energy to the cartilage of the nasal septum.
8. The method of claim 7, wherein the period of time is between 15
minutes and 90 minutes.
9. The method of claim 7, wherein the period of time is selected to
be sufficient for the substance to create a band of degraded
cartilage ranging from 100 .mu.m to 1 mm from a surface of the
cartilage.
10. (canceled)
11. The method of claim 1, wherein injecting the substance
comprises injecting into a space between the nasal mucosa and the
cartilage.
12. The method of claim 1, further comprising defining an area of
application of the substance by providing a physical barrier to
contain the substance.
13. The method of claim 1, wherein applying the radiofrequency
energy to the cartilage of the nasal septum comprises heating the
cartilage.
14. The method of claim 13, wherein heating the cartilage of the
nasal septum comprises heating the cartilage to a temperature
selected to denature or deactivate the substance.
15. (canceled)
16. The method of claim 1, wherein changing the shape of the
cartilage comprises correcting a deviation of the nasal septum.
17.-19. (canceled)
20. The method of claim 17, further comprising: inserting a
reshaping device into the patient's nose, such that a first
treatment element of the reshaping device is positioned on one side
of the nasal septum and a second treatment element of the reshaping
device is positioned on an opposite side of the nasal septum; and
reshaping the nasal septum using the first treatment element and
the second treatment element at least one of before, during or
after applying the radiofrequency energy.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/429,947, filed Feb. 10, 2017, which claims
the benefit of U.S. Provisional Application No. 62/294,724, filed
on Feb. 12, 2016, and U.S. Provisional Application No. 62/335,802,
filed on May 13, 2016. The disclosures of these priority
applications are hereby incorporated by reference in their
entireties herein.
[0002] Embodiments described in this application may be used in
combination or conjunction with the subject matter described in the
following applications, which are hereby fully incorporated by
reference for any and all purposes as if set forth herein in their
entireties: U.S. patent application Ser. No. 14/026,922, filed Sep.
13, 2013, entitled "METHODS AND DEVICES TO TREAT NASAL AIRWAYS,"
issued Mar. 24, 2015, as U.S. Pat. No. 8,986,301; U.S. patent
application Ser. No. 14/675,689, filed Mar. 31, 2015, entitled
"POST NASAL DRIP TREATMENT," issued Aug. 16, 2016, as U.S. Pat. No.
9,415,194; and U.S. patent application Ser. No. 15/175,651, filed
Jun. 7, 2016, entitled "PRESSURE SENSITIVE TISSUE TREATMENT
DEVICE," issued on Feb. 13, 2018 as U.S. Pat. No. 9,888,957.
FIELD OF THE INVENTION
[0003] This application relates generally to the field of medical
devices and treatments, and in particular to systems, devices and
methods for treating tissue, such as the hyaline cartilage of
structures within the nose and upper airway.
BACKGROUND
[0004] During respiration, the anatomy, shape, tissue composition,
and properties of the human airway produce airflow resistance. The
nose is responsible for almost two thirds of this resistance. Most
of this resistance occurs in the anterior part of the nose, known
as the internal nasal valve, which acts as a flow-limiter. The
external nasal valve structure also causes resistance to nasal
airflow. Effective physiological normal respiration occurs over a
range of airflow resistances. However, excessive resistance to
airflow can result in abnormalities of respiration that can
significantly affect a patient's quality of life. Poor nasal
breathing and/or nasal congestion has profound effects on a
person's health and quality of life, which can be measured by
validated questionnaires, such as the NOSE score, as described in
Stewart M G, Witsell D L, Smith T L, Weaver E M, Yueh B, and
Hannley M T., "Development and Validation of the Nasal Obstruction
Symptom Evaluation (NOSE) Scale," Otolaryngol Head Neck Surg 2004;
130:157-63.
[0005] Inadequate nasal airflow can result from a number of
conditions causing an inadequate cross-sectional area of the nasal
airway in the absence of any collapse or movement of the cartilages
and soft tissues of the nasal airway. A common cause of inadequate
nasal airflow is deviation of the nasal septum. The nasal septum is
a wall of tissue that separates the nasal cavity into two nostrils.
The septum is made up of bone, hyaline cartilage, and nasal mucosa.
The American Academy of Otolaryngology estimates that many as 80%
of adults have a nasal septum that is slightly off center. A more
severe shift away from the midline of the nose, known as a deviated
septum, frequently results in difficulty breathing and can often
precipitate chronic sinusitis. The most common means of correcting
a deviation is partial or full removal of the nasal septum, known
as a septoplasty. More than 250,000 septoplasties are performed in
the United States each year. Although septoplasty can be an
effective treatment, it is also quite invasive, can lead to a
painful and difficult recovery, and is associated with a number of
risks and potential side effects, as with any invasive surgical
procedure. It is estimated that only about 10% of patients with a
deviated septum will elect to have surgery, in part due to the
risks and invasiveness of the procedure.
[0006] Therefore, it would be advantageous to have improved methods
and devices for treating a deviated septum, to help improve
breathing and/or alleviate other symptoms in a patient. Ideally,
such methods and devices would provide a non-surgical, minimally
invasive or less invasive approach for correcting deviated septa
and thus would provide patients with a less painful alternative
treatment, with fewer risks and side effects and easier recovery.
At least some of these objectives are addressed by the embodiments
described in this application.
SUMMARY
[0007] Embodiments of the present application are directed to
devices, systems and methods for treating nasal airways. Such
embodiments may be used to improve breathing by decreasing airflow
resistance or perceived airflow resistance in the nasal airways.
For example, the devices, systems and methods described herein may
be used to reshape, remodel, strengthen, or change the properties
of the tissues of the nose, including, but not limited to the skin,
muscle, mucosa, submucosa and cartilage in the area of the nasal
septum.
[0008] The nasal septum forms a portion of the nasal valve. The
nasal valve is divided into external and internal portions. The
external nasal valve is the external nasal opening formed by the
columella at the base of the septum, the nasal floor, and the nasal
rim (the lower region of the nasal wall, also known as the caudal
border of the lower lateral cartilage). The nasalis muscle dilates
the external nasal valve portion during inspiration. The internal
nasal valve, which accounts for a large part of the nasal
resistance, is located in the area of transition between the skin
and respiratory epithelium. The internal nasal valve area is formed
by the nasal septum, the caudal border of the upper lateral
cartilage (ULC), the head of the inferior turbinate, and the
pyriform aperture and the tissues that surround it. An angle formed
between the caudal border of the ULC and the nasal septum is
normally between about 10 degrees and about 15 degrees, as
illustrated in FIG. 1.
[0009] In one aspect, a method for modifying a nasal septum of a
subject's nose may involve: applying a solution to the nasal
septum, where the solution is configured to modify cartilage of the
nasal septum; providing a time period for the solution to modify
the cartilage; inserting a device into the subject's nose; applying
energy to the nasal septum using the device; reshaping the
cartilage using the device; and removing the device.
[0010] In various embodiments, the solution may be collagenase,
hyaluronidase, tosyl lysyl chloromethane, trypsin, trypsin/EDTA, or
some combination thereof. In some embodiments, the solution is
configured to soften the cartilage of the nasal septum. In some
embodiments, the solution is configured to dissolve proteoglycan
structures of the cartilage. In one embodiment, for example, the
solution may include about 0.5 ml to 2.5 ml of collagenase at a
concentration ranging from about 1 mg/ml to 10 mg/ml. In another
embodiment, the solution may include between about 0.5 ml to 2.5 ml
of trypsin at a concentration of about 10 .mu.g/ml to about 100
.mu.g/ml.
[0011] In some embodiments, the time period for the solution to
modify the cartilage may be between about 15 minutes to about 90
minutes. In some embodiments, providing the time period for the
solution to modify the cartilage may involve providing a time
period for the solution to create a band of degraded cartilage
ranging from about 100 .mu.m to about 1 mm from a surface of the
cartilage. In some embodiments, applying the solution may involve
injecting the solution into or near the cartilage. In some
embodiments, injecting the solution into or near the cartilage may
involve injecting the solution through nasal mucosal tissue to a
space between the nasal mucosa and the cartilage.
[0012] Optionally, the method may also involve defining an area of
application of the solution by providing a physical barrier to
contain the applied solution. In some embodiments, applying energy
to the nasal septum using the device may involve heating tissue of
the nasal septum. In some embodiments, the method may include
heating tissue of the nasal septum to a temperature selected to
denature or deactivate the solution. In some embodiments, the
device may include a radiofrequency electrode. In some embodiments,
reshaping the cartilage using the device may involve correcting a
septal deviation.
[0013] In another aspect, a method for treating a deviated nasal
septum in a patient's nasal cavity may involve applying a cartilage
modifying substance to cartilage of the deviated nasal septum and
applying energy to the nasal septum via an energy delivery device
to treat the deviated nasal septum. Optionally, the method may also
involve allowing the substance to remain in the cartilage of the
nasal septum for a predetermined time period before applying the
energy. For example, in various embodiments, the predetermined time
period may be between about 15 minutes and about 90 minutes.
[0014] In various embodiments, the substance may be any of
collagenase, hyaluronidase, tosyl lysyl chloromethane, trypsin,
trypsin/EDTA, or a combination thereof. In some embodiments, the
substance may be a collagen softening substance. In some
embodiments, the substance may be a proteoglycan dissolving
substance. One embodiment of a substance may be about 0.5 ml to
about 2.5 ml of collagenase at a concentration ranging from about 1
mg/ml to about 10 mg/ml. Another embodiment of a substance may be
between about 0.5 ml to about 2.5 ml of trypsin at a concentration
of about 10 .mu.g/ml to about 100 .mu.g/ml.
[0015] In some embodiments, applying the substance may involve
injecting the substance into or near the cartilage. For example,
some embodiments may involve injecting the substance through nasal
mucosal tissue to a space between the nasal mucosa and the
cartilage. Optionally, the method may also include forming a
physical barrier within the patient's nasal cavity to contain the
applied substance in or near the nasal septum.
[0016] The energy applied may be any suitable energy, such as but
not limited to radiofrequency, heat, electrical, ultrasound,
microwave and/or cryogenic energy. In some embodiments, applying
energy to the nasal septum may involve heating tissue of the nasal
septum to a temperature selected to denature or deactivate the
substance. In some embodiments, the method may also involve
applying pressure to the nasal septum, using the energy delivery
device, to reshape the septum. In some embodiments, the substance
may be applied via the energy delivery device. In alternative
embodiments, it may be applied with a separate device, such as a
needle and syringe. In various embodiments, the cartilage of the
nasal septum may include hyaline cartilage.
[0017] In some embodiments, correcting a deviated septum of a
subject's nose may involve applying a solution to a nasal septum of
a subject's nose having a deviation. The solution may be configured
to modify cartilage of the nasal septum. Correcting a deviated
septum may further involve inserting a device into the subject's
nose such that a first treatment element of the device is
positioned on a side of septum and a second treatment element of
the device is positioned on an opposite side of the septum.
Correcting a deviated septum may further involve applying energy to
the nasal septum using the first treatment element or the second
treatment element. Correcting a deviated septum may further involve
reshaping the cartilage using the first treatment element and the
second treatment element, thereby correcting the deviated nasal
septum.
[0018] In some embodiments, treating a deviated septum may involve
inserting a device into a subject's nose having a deviation, the
device having an elongate treatment element. Treating a deviated
septum may also involve creating an air channel in the deviation
using the elongate treatment element of the device, thereby
reducing the deviation and improving airflow. Treating a deviated
septum may further involve removing the device from the subject's
nose. The air channel in the deviation may persist after the device
is removed.
[0019] In some embodiments, treating a deviated septum may involve
applying a solution to the nasal septum having a deviation. The
solution may be configured to modify cartilage of the nasal septum.
Treating a deviated septum may further involve providing a dwell
time for the solution to modify cartilage of the nasal septum.
Treating a deviated septum may further involve removing the
modified cartilage of the nasal septum, thereby treating the
deviated septum of the subject's nose.
[0020] In some embodiments, a device for treating a deviated septum
of a subject's nose, may include a handle, an elongate shaft
extending from the handle, and an elongate treatment element
extending from the elongate shaft and configured to create channels
in the deviated septum of the subject's nose. The elongate
treatment element can be configured to apply energy to or remove
energy from tissue of the deviated septum of the subject's nose.
The device can include multiple pairs of bipolar electrodes
arranged in a serial alignment along the treatment element. The
pairs of bipolar electrodes can be arranged with the center of the
electrodes along a longitudinal axis of the treatment element.
[0021] These and other aspects and embodiments will be described in
further detail below, in reference to the attached drawing
figures.
BRIEF DESCRIPTION OF DRAWINGS
[0022] FIG. 1 depicts an illustration of bone and cartilage
structures of a human nose.
[0023] FIG. 2A shows a cross-sectional view, illustrating tissues
and structures of a human nose.
[0024] FIG. 2B shows a detailed cross-sectional view, illustrating
a detailed section of the structures of FIG. 2A.
[0025] FIG. 2C shows a view of the nostrils, illustrating tissues
and structures of a human nose.
[0026] FIG. 3 depicts a schematic illustration of a nasal septum
reshaping treatment device.
[0027] FIG. 4A is a perspective illustration of an embodiment of a
treatment element shape.
[0028] FIG. 4B depicts a perspective illustration of another
embodiment of a treatment element shape.
[0029] FIG. 4C shows a perspective illustration of another
embodiment of a treatment element shape.
[0030] FIG. 4D depicts a cross-sectional view of a treatment device
comprising a plurality of microneedles puncturing tissue in order
to apply treatment at a desired tissue depth.
[0031] FIG. 5A illustrates one embodiment of a clamp-type nasal
septum treatment device.
[0032] FIG. 5B illustrates another embodiment of a clamp-type nasal
septum treatment device.
[0033] FIG. 6 depicts a partially-transparent perspective view,
showing a stent implanted in a nose.
[0034] FIG. 7 depicts a perspective view, illustrating an energy
delivery balloon being inserted into a nose.
[0035] FIGS. 8A-8J depict embodiments of various electrode
arrangements for applying energy to the nasal septum area.
[0036] FIGS. 9A and 9B illustrate embodiments of devices for
applying energy to the nasal septum area using a monopolar
electrode.
[0037] FIGS. 10A and 10B illustrate an embodiment of a device for
applying energy to the nasal septum area using a monopolar
electrode and an external mold.
[0038] FIGS. 11A and 11B illustrate embodiments of devices for
applying energy to the nasal septum area using electrode(s) and a
counter-traction element.
[0039] FIGS. 12A and 12B illustrate embodiments of devices for
applying energy to the nasal septum area and configured to be
inserted into both nostrils simultaneously.
[0040] FIGS. 13A-13E illustrate embodiments of devices for applying
energy to the nasal septum area configured to be inserted into both
nostrils simultaneously, having a mold or counter-traction element
for engaging the nose externally.
[0041] FIGS. 14A and 14B illustrate embodiments of devices for
applying energy to the nasal septum area configured to be inserted
into both nostrils simultaneously, having separate external
molds.
[0042] FIGS. 15A-15C illustrate embodiments of devices for applying
energy to the nasal septum area configured to be inserted into both
nostrils simultaneously, having separate counter-traction
elements.
[0043] FIG. 16 shows an embodiment of a system comprising a device
for applying energy to the nasal septum area with an external
electrode and a separate internal mold.
[0044] FIGS. 17A and 17B illustrate an embodiment of a device for
applying energy to the nasal septum area comprising an external
electrode and an internal mold.
[0045] FIG. 18 shows an embodiment of a device for applying energy
to the nasal septum area comprising an array of non-penetrating
electrodes.
[0046] FIGS. 19A and 19B illustrate an embodiment of a device for
applying energy to the nasal septum area configured for use in only
one nostril.
[0047] FIGS. 20A and 20B illustrate an embodiment of a device for
applying energy to the nasal septum area configured for use in
either nostril.
[0048] FIGS. 21A and 21B illustrate an embodiment of a device for
applying energy to the nasal septum area having a symmetrical
shape.
[0049] FIGS. 22A-22G illustrate an embodiment of a device for
applying energy to the nasal septum area using a monopolar
electrode.
[0050] FIGS. 23A-23G illustrate an embodiment of a device for
applying energy to the nasal septum area using an array of needle
electrodes.
[0051] FIG. 24A depicts a cross-section of tissue at the nasal
septum.
[0052] FIG. 24B depicts heat effects of RF treatment of tissue at
the nasal septum.
[0053] FIGS. 25A and 25B illustrate embodiments of devices for
applying energy to the nasal septum area incorporating cooling
systems.
[0054] FIG. 26 shows an embodiment of a device for applying energy
to the nasal septum area incorporating a heat pipe.
[0055] FIG. 27 depicts an embodiment of a device for applying
energy to the nasal septum area incorporating heat pipes.
[0056] FIGS. 28A-28E depict embodiments of differential cooling
mechanisms.
[0057] FIG. 29 shows an embodiment of a system comprising a device
for applying energy to the nasal septum area with electrode needles
and a separate cooling mechanism.
[0058] FIGS. 30A-30D show an embodiment of a method for modifying a
nasal septum.
[0059] FIGS. 30E-30H show an embodiment of a method for applying
energy to the nasal septum area using a device for applying energy
to the nasal septum area.
[0060] FIGS. 31A and 31B are a perspective view and a side,
cross-sectional view, respectively, of a device for applying energy
to the nasal septum area, including an internal power source,
according to one embodiment.
[0061] FIGS. 32A and 32B are a cross-sectional side view of facial
skin and a front view of a face of a patient, respectively,
illustrating use of various embodiments of sensors that may be part
of a system for applying energy to the nasal septum area, according
to one embodiment.
[0062] FIGS. 33A and 33B are a bottom view of a distal end of a
treatment device and a cross-sectional view of a nasal passage,
respectively, illustrating wings of the treatment device that may
be used to help guide the distal end to a desired location in the
nasal passage.
[0063] FIGS. 34A-34C are top views of various alternative
embodiments of distal ends of treatment devices having different
shapes for addressing differently shaped tissues.
[0064] FIG. 35 is a top view of a treatment device and a
cross-sectional view of a portion of a nose, in which the treatment
device includes an expandable member, according to one
embodiment.
[0065] FIGS. 36A-36E illustrate a method and device for treating a
septum having a deviation, according to some embodiments.
[0066] FIG. 37 illustrates a channel stylus device that may be used
to treat a deviated septum, according to some embodiments.
[0067] FIGS. 38A-38C illustrate a method of treating a septum
having a deviation using a channel stylus device, according to some
embodiments.
[0068] FIGS. 39A-39D illustrate a method of treating a deviated
septum by treating and evacuating cartilage, according to some
embodiments.
DETAILED DESCRIPTION
[0069] The following disclosure provides embodiments of systems and
methods for shaping, bending, and/or volumetrically reducing rigid
cartilaginous structures, such as hyaline cartilage in a nasal
septum. In the case of septal cartilage, shaping, bending, or
reducing the cartilage would be useful for reducing nasal
obstruction or to improve the cosmetic appearance of the nose. The
treatment may improve breathing by correcting deviations in a
subject's nasal septum, thereby decreasing airflow resistance or
perceived airflow resistance.
[0070] Treatment of hyaline cartilage of the nasal septum presents
several unique challenges, any or all of which may be addressed by
the embodiments described in this application. For example, shaping
and bending of hyaline cartilage may be difficult, due to its stiff
and brittle nature. Further, some techniques that are effective at
disrupting the matrix of elastic cartilage of certain portions of
the nasal valve may not be effective at reshaping hyaline cartilage
in the nasal septum, which may need more than the application of
energy alone for modification. Disclosed embodiments may provide
for modifying hyaline cartilage by, for example, providing methods
and devices for softening the cartilage of the nasal septum (e.g.,
by applying a solution at or near the nasal septum) in addition to
reshaping, remodeling, or changing the properties of the
tissues.
[0071] While, in some instances, nasal dysfunction can lead to poor
airflow, nasal breathing can also be improved in people with normal
breathing and/or normal nasal anatomy by decreasing nasal airflow
resistance in the nasal valve and associated nasal anatomy.
Remodeling or changing the structure of the nasal septum can
improve nasal airflow. Prior methods and systems generally involve
invasive methods or unsightly devices that a person with normal
breathing and/or anatomy may not necessarily be inclined to use or
undergo. Thus, there remains an unmet need in the art for
non-invasive and minimally invasive methods and devices to decrease
nasal airflow resistance or perceived nasal airflow resistance
and/or to improve nasal airflow or perceived nasal airflow and the
resulting symptoms or sequella of poor nasal airflow--including but
not limited to snoring, sleep disordered breathing, perceived nasal
congestion and poor quality of life--through the change of
structures within the nose that form the passageways for airflow.
Methods and devices described herein may be used to treat nasal
airways or other cartilaginous areas without the need for more
invasive procedures (e.g., ablation or surgery).
[0072] Nasal breathing can be improved in people with normal
breathing and/or normal nasal anatomy by decreasing nasal airflow
resistance or perceived nasal airflow resistance in the nasal valve
and associated nasal anatomy. Restructuring the shape,
conformation, angle, strength, and cross sectional area of the
nasal septum may improve nasal airflow. Changing the nasal septum
can be performed alone or together with other procedures (e.g.,
surgical procedures), such as those described above. Such methods
and devices can lead to improved nasal airflow and/or increased
volume of nasal airflow in patients with normal or reduced nasal
airflow.
[0073] FIGS. 1 and 2A-C illustrate anatomical elements of a human
nose. The lower lateral cartilage (LLC) includes an external
component referred to as the lateral crus and an internal component
referred to as the medial crus. The medial crus and septal nasal
cartilage create a nasal septum that separates the left and right
nostrils. Upper lateral cartilage lies between the lower lateral
cartilages and the nasal bone. The left ULC is separated from the
right ULC by the septal cartilage extending down the bridge of the
nose. The opposing edges of the LLC and ULC may move relative to
one another. Disposed between the opposing edges is an accessory
nasal cartilage. The septal nasal cartilage and the ULC form an
angle (.theta.) called the nasal valve angle.
[0074] FIG. 2B illustrates a detailed cross-section of a segment of
nose tissue in the area of the intersection of the ULC and the LLC.
As shown in the detailed view of FIG. 2A, both inner and outer
surfaces of the nasal cartilage are covered with soft tissue
including mucosa, sub-mucosa and skin.
[0075] FIG. 2C illustrates a view of the nose as seen from the
nostrils. FIG. 2 depicts the nasal valve 1 shown between the septum
2 and the ULC 3. FIG. 2A also depicts the position of the turbinate
4.
[0076] The internal nasal septum area of the nasal airway passage
can be visualized prior to and/or during any treatment by any
suitable method, including but not limited to direct visualization,
endoscopic visualization, visualization by the use of a speculum,
transillumination, ultrasound, MRI, x-ray or any other method. In
some embodiments, treatments of the nasal septum area as described
herein may be performed in conjunction with or following another
procedure (e.g., a surgical procedure such as rhinoplasty and/or
modification of the nasal valve). In such embodiments, the nasal
septum area may be visualized and accessed during surgery. In some
embodiments, it may be desirable to visualize the internal nasal
septum with minimum disturbance, so as to avoid incorrect
assessments due to altering the shape of the nasal septum during
visualization. In some embodiments, visualization elements may be
incorporated into or combined with treatment devices configured for
treating internal and/or external nasal septum.
[0077] Airflow through the nasal passage can be measured prior to
and/or during any treatment by any suitable method, including, but
not limited to, a nasal cannula connected to a pressure measurement
system, rhinomanometry, and rhino-hygrometer. Nasal airflow and
resistance can also be evaluated by subjective evaluation before
and after a manipulation to increase the cross-sectional area of
the nasal passage, such as the Cottle maneuver. In some
embodiments, it may be desirable to measure nasal airflow and/or
resistance prior to, during and/or after a procedure.
[0078] The nasal septum area of the nasal airway passage can be
accessed through the nares. In some embodiments, one or more
devices may be used to pull the tip of the nose caudally and
increase the diameter of the nares in order to further facilitate
access to the nasal septum for treatment. Such devices may include
speculum type devices and retractors. In other embodiments, access
to the nasal septum may also be achieved endoscopically via the
nares, or via the mouth and throat. In some embodiments,
visualization devices may be incorporated or combined with
treatment devices for treating internal and/or external nasal
valves. These and any other access and/or visualization devices may
be used with any of the methods and devices below.
[0079] Some embodiments below provide apparatus and methods for
modifying cartilage, such as hyaline cartilage. Some embodiments
below provide apparatus and methods for modifying the nasal septum
and/or modifying the structure and/or structural properties of
tissues at or adjacent to the nasal septum.
[0080] In some embodiments, airflow restrictions to the internal
nasal valve may be the result of a smaller-than-optimal internal
nasal valve angle, shown as .theta. in FIG. 2A. An internal nasal
valve angle (i.e., the angle formed between the caudal border of
the ULC and the nasal septum) of less than the normally optimal
range of between about 10 degrees and about 15 degrees can result
in airflow restrictions. Thus, in some embodiments, treatments may
be designed to reshape structures at or adjacent to the nasal
septum in order to increase the internal nasal valve angle
sufficiently that after such treatments, the nasal valve angle
falls within the optimal range of about 10-15 degrees. In some
embodiments, the internal valve angle may also be increased to be
greater than 15 degrees.
[0081] In some embodiments, airflow restrictions to the internal
nasal valve may be the result of a smaller-than-optimal area of the
internal nasal valve. An internal nasal valve with a less than
optimal area can result in airflow restrictions. Thus, in some
embodiments, treatments may be designed to reshape structures at or
adjacent to the nasal septum in order to increase the internal
nasal valve angle sufficiently that after such treatments, the area
of the nasal valve falls within an optimal range. In some
embodiments, modifying the nasal septum without increasing the
angle of the nasal valve may improve airflow. In some embodiments,
increasing the angle of the nasal valve without increasing the area
of the opening at the nasal valve may improve airflow. In some
embodiments, both the opening at the area of the nasal valve and
the angle of the nasal valve may be increased to improve
airflow.
[0082] In some embodiments, nasal airflow can be increased in the
presence of normal nasal anatomy and/or normal or enlarged nasal
valve angle or area.
[0083] With reference to FIG. 2A, in some embodiments, the internal
valve angle .theta. or area may be increased by mechanically
pressing against the nasal septum. In some embodiments, this
pressing may be performed by an inflatable balloon (such as those
discussed below with reference to FIGS. 4A-4B), which may be
positioned between the upper portion of the nasal septum 20 and the
outer lateral wall 22 and then inflated, pressing against the nasal
septum until the nasal valve angle reaches a desired size.
Similarly, other mechanical devices such as spreaders or retractors
(such as those discussed below with reference to FIGS. 5A and 5B)
or molds may be used. In alternative embodiments, short-term
removable implants may be used to reshape the nasal septum. Some
examples of short-term implants may include stents, molds or plugs.
In further alternative embodiments, external reshaping elements,
such as adhesive strips or face masks may be used to modify the
shape of a nasal valve and/or septum. In some embodiments, energy
application or other treatments as described below may be applied
to substantially fix the reshaped tissue in a desired
conformational shape before, during or after applying a mechanical
reshaping force (e.g., with the balloon, mechanical devices, molds,
short-term implants, or external reshaping elements described above
or any of the mechanical devices described below).
[0084] In some embodiments, before, during or after reshaping the
nasal tissue, the cartilage of the septum may be softened or
otherwise modified. A cartilage softening or dissolving agent may
be used to pre-treat cartilage, allowing it to be subsequently
bent, shaped and/or reduced by energy application(s) and/or
mechanical force. The cartilage may be softened at a surface of the
tissue, so as to maintain the mechanical integrity of the nose as a
whole but still enable sufficient reshaping, to alleviate the
symptoms of a deviation. In some embodiments, the pre-treatment may
substantially soften and/or dissolve the cartilage, such that the
mechanical integrity of the cartilage is compromised.
[0085] In one embodiment, the cartilage may be treated with
solutions via injections, topical applications, or direct infusions
from the surface or surfaces of a device. The solutions may be
selected to modify properties of the cartilage for subsequent
modification. The solutions may include, but are not limited to
collagenase, hyaluronidase, tosyl lysyl chloromethane, trypsin,
trypsin/EDTA, and/or combinations thereof. Collagenase and trypsin
are naturally occurring enzymes in the human body.
[0086] In the case of trypsin, proteoglycan structures of cartilage
may be dissolved, leaving a compliant collagen matrix that may be
subsequently heated, such as with radiofrequency energy. Heating
the compliant matrix may denature, and thus shrink or bend, the
cartilage into a more favorable position. Moreover, the heating can
be used to stop the propagation of proteoglycan digestion by
rendering the trypsin inactive.
[0087] In another method, collagenase may be used to digest both
the proteoglycan and collagen matrix of the cartilage. Remaining
cartilage and other tissues may then be shaped or further reduced
as necessary using radiofrequency heating or by other energy
modalities.
[0088] In one embodiment, a device may be configured to inject the
solution into or near the tissue to be treated. The device may
define the area of application to the cartilage by amount and
number of sites injected and/or by providing a physical barrier,
such as a ring pressed against the nasal mucosa that
corrals/contains the injected enzyme between the mucosa and the
cartilage.
[0089] As described above, the solution (e.g., a tissue dissolving
agent) may be applied to the tissue (e.g., cartilage) via
injections, topical applications, transmucosal delivery devices,
and/or other manners. Once the agent has affected the tissue, a
heating device is used to reduce and/or shape the tissue by
applying energy/heat to the target area. The device is inserted
into the nose and held against the target tissue, or alternately
applied via a transmucosally inserted device. The energy is
applied, and then the device is removed (e.g., once all target
tissue has been treated).
[0090] In one embodiment, the heating device may be an RF Stylus.
The stylus may include a single- or multi-electrode head, which is
configured to apply RF energy to the septal cartilage through the
nasal mucosa. The device may also be capable of measuring tissue
temperature, impedance, wattage, and/or other properties to
effectively alter power to the stylus to maintain desired RF energy
and temperature.
[0091] In another embodiment, a reshaping device may be used to
expand the diameter of the nasal passage at the nasal septum. The
expansion device can be a balloon, a user controlled mechanical
device, a self-expanding mechanical device, a fixed shape device,
or any combination thereof. The expansion can increase the diameter
over the normal range, in order for the diameter to remain expanded
after removal of the device and healing of the tissue.
[0092] In some embodiments, a reshaping device may be used to
conformationally change the structure of the nasal septum anatomy
to allow greater airflow, without necessarily expanding the
diameter of the nasal passage.
[0093] In some embodiments, a reshaping or remodeling device can be
used to conformationally change the structure of areas of the nasal
septum that causes the cross sectional or three dimensional
structure of the nasal airway to assume a shape less restrictive to
airflow without widening the nasal valve angle.
[0094] In some embodiments, energy may be applied in the form of
heat, radiofrequency (RF), laser, light, ultrasound (e.g. high
intensity focused ultrasound), microwave energy, electromechanical,
mechanical force, cooling, alternating or direct electrical current
(DC current), chemical, electrochemical, or others. In some
embodiments, the nasal septum, nasal valve, and/or surrounding
tissues may be strengthened through the application of cryogenic
therapy, or through the injection or application of bulking agents,
glues, polymers, collagen and/or other allogenic or autogenic
tissues, or growth agents.
[0095] Any one or more of the above energy-application mechanisms
may also be used to reshape, remodel, or change mechanical or
physiologic properties of structures of a nasal septum or
surrounding tissues. For example, in some embodiments, energy may
be applied to a targeted region of tissue such that the tissue
modification results in a tightening, shrinking or enlarging of
such targeted tissues resulting in a change of shape. In some such
embodiments, reshaping of a nasal septum section may be achieved by
applying energy without necessarily applying a mechanical reshaping
force. For example energy can be used to selectively shrink tissue
in specific locations of the nasal airway that will lead to a
controlled conformational change.
[0096] In some embodiments, strengthening and/or conformation
change (i.e., reshaping) of nasal septum tissue to reduce negative
pressure during inspiration may include modification of tissue
growth and/or the healing and fibrogenic process. For example, in
some embodiments energy may be applied to a targeted tissue in the
region of the nasal septum in such a way that the healing process
causes a change to the shape of the nasal septum and/or a change in
the structural properties of the tissue. In some embodiments, such
targeted energy application and subsequent healing may be further
controlled through the use of temporary implants or reshaping
devices (e.g., internal stents or molds, or external adhesive
strips).
[0097] In some embodiments, energy may be delivered into the
cartilage tissue to cause a conformational change and/or a change
in the physical properties of the cartilage. Energy delivery may be
accomplished by transferring the energy through the tissue covering
the cartilage such as the epithelium, mucosa, sub-mucosa, muscle,
ligaments, tendon and/or skin. In some embodiments, energy may also
be delivered to the cartilage using needles, probes or microneedles
that pass through the epithelium, mucosa, submucosa, muscle,
ligaments, tendon and/or skin (as illustrated for example in FIG.
4D).
[0098] In some embodiments, energy may be delivered into the
submucosal tissue to cause a conformational change and/or a change
in the physical properties of the submucosal tissue. Energy
delivery may be accomplished by transferring the energy through the
tissue covering the submucosa such as the epithelium, mucosa,
muscle, ligaments, cartilage, tendon and/or skin. In some
embodiments, energy may also be delivered to the submucosa using
needles, probes, microneedles, micro blades, or other non-round
needles that pass through the epithelium, mucosa, muscle,
ligaments, tendon and/or skin.
[0099] FIG. 3 illustrates an embodiment of a nasal septum treatment
device 30. The device 30 comprises a treatment element 32 which may
be configured to be placed inside the nasal cavity, nasal passage,
and/or nasal airway to deliver the desired treatment. In some
embodiments, the device 30 may further comprise a handle section 34
which may be sized and configured for easy handheld operation by a
clinician. In some embodiments, a display 36 may be provided for
displaying information to a clinician during treatment.
[0100] In some embodiments, the information provided on the display
36 may include treatment delivery information (e.g. quantitative
information describing the energy being delivered to the treatment
element) and/or feedback information from sensors within the device
and/or within the treatment element. In some embodiments, the
display may provide information on physician selected parameters of
treatment, including time, power level, temperature, electric
impedance, electric current, depth of treatment and/or other
selectable parameters.
[0101] In some embodiments, the handle section 34 may also comprise
input controls 38, such as buttons, knobs, dials, touchpad,
joystick, etc. In some embodiments, controls may be incorporated
into the display, such as by the use of a touch screen. In further
embodiments, controls may be located on an auxiliary device which
may be configured to communicate with the treatment device 30 via
analog or digital signals sent over a cable 40 or wirelessly, such
as via BLUETOOTH, WI-FI (or other 802.11 standard wireless
protocol), infrared or any other wired or wireless communication
method.
[0102] In some embodiments the treatment system may comprise an
electronic control system 42 configured to control the timing,
location, intensity and/or other properties and characteristics of
energy or other treatment applied to targeted regions of a nasal
passageway. In some embodiments, a control system 42 may be
integrally incorporated into the handle section 34. Alternatively,
the control system 42 may be located in an external device which
may be configured to communicate with electronics within the handle
section 34. A control system may include a closed-loop control
system having any number of sensors, such as thermocouples,
electric resistance or impedance sensors, ultrasound transducers,
or any other sensors configured to detect treatment variables or
other control parameters.
[0103] The treatment system may also comprise a power supply 44. In
some embodiments, a power supply may be integrally incorporated
within the handle section 34. In alternative embodiments, a power
supply 44 may be external to the handle section 34. An external
power supply 44 may be configured to deliver power to the handle
section 34 and/or the treatment element 32 by a cable or other
suitable connection. In some embodiments, a power supply 44 may
include a battery or other electrical energy storage or energy
generation device. In other embodiments, a power supply may be
configured to draw electrical power from a standard wall outlet. In
some embodiments, a power supply 44 may also include a system
configured for driving a specific energy delivery technology in the
treatment element 32. For example, the power supply 44 may be
configured to deliver a radio frequency alternating current signal
to an RF energy delivery element. Alternatively, the power supply
may be configured to deliver a signal suitable for delivering
ultrasound or microwave energy via suitable transducers. In further
alternative embodiments, the power supply 44 may be configured to
deliver a high-temperature or low-temperature fluid (e.g. air,
water, steam, saline, or other gas or liquid) to the treatment
element 32 by way of a fluid conduit.
[0104] In some embodiments, the treatment element 32 may have a
substantially rigid or minimally elastic shape sized and shaped
such that it substantially conforms to an ideal shape and size of a
patient's nasal passageway, including the nasal septum. In some
embodiments, the treatment element 32 may have a curved shape,
either concave or convex with respect to the interior of the
lateral wall of the nasal passage. In some embodiments, the shape
of a fixed-shape treatment element may be substantially in a shape
to be imparted to the cartilage or other structures of the nasal
septum area.
[0105] In some embodiments, the treatment element 32 and control
system 42 may be configured to modify the properties of cartilage
and/or create specific localized tissue damage or ablation without
the application of energy. For example, the treatment element 32
may be configured to apply (e.g., inject) a solution that modifies
the properties of cartilage (e.g., collagenase, hyaluronidase,
tosyllysylchloromethane, trypsin, trypsin/EDTA, and/or combinations
thereof) at or near the tissue to be treated. In one embodiment,
for example, the treatment element 32 may include one or more
needles to inject the solution (e.g., into the space between the
septal cartilage and the mucosal layer). In another embodiment, the
treatment element 32 may be configured to chemically cauterize
tissue around a nasal septum by delivering a cauterizing solution
(e.g., silver nitrate, trichloroacetic acid, cantharidin, etc.) to
the tissue. The treatment element 32 may include apertures
configured to permit the solution to pass through to the nose. In
some embodiments, the treatment element 32 may aerosolize the
solution. Other delivery methods are also contemplated. The
treatment element 32 may comprise a lumen, through which the
solution passes. The lumen may be fluidly connected to a reservoir
or container holding the solution. The device may include an input
control (e.g., a button or switch) configured to control the
delivery of the solution. In some embodiments, the treatment
element 32 may include an applicator that can be coated in the
solution (e.g., dipped in a reservoir of solution, swabbed with the
solution, etc.) and the coated treatment element applicator may be
applied to tissue to be treated. In some embodiments, the treatment
element may be configured to apply the solution to the patient over
a prolonged period of time (e.g., 30 seconds, 1 minute, 2 minutes,
etc.).
[0106] In some embodiments, the treatment element 32 comprises
shields or rings configured to protect tissue surrounding the
tissue to be treated from coming into contact with the solution. In
some embodiments, a separate element is used to shield tissue
surrounding the tissue to be treated from coming into contact with
the solution. While such treatments may be performed without the
application of energy, in some embodiments, they may be performed
in conjunction with energy treatments. In one embodiment, one or
more shields may be configured to be placed on the nasal septum
mucosa around the site of the deviation. In one embodiment, for
example, there may be two rings--one for each side of the septum.
The design of the device may be "U" shaped to fit the two arms of
device into the two nostrils of the patient. The device may be
spring loaded, such that when a user releases the device, the
device is held in place by its spring force.
[0107] In some embodiments, as shown for example in FIG. 3, the
treatment element 32 may comprise a substantially cylindrical
central portion with a semi-spherical or semi-ellipsoid or another
shaped end-cap section at proximal and/or distal ends of the
treatment element 32. In alternative embodiments, the treatment
element may comprise a substantially ellipsoid shape as shown, for
example in FIGS. 4A-4D. In some embodiments, an ellipsoid balloon
as shown in FIG. 4A may have an asymmetrical shape. In alternative
embodiments, the treatment element 32 may have an asymmetrical
"egg-shape" with a large-diameter proximal end and a
smaller-diameter distal end. In some embodiments, the element 32
can be shaped so as to impart a shape to the tissue treated that is
conducive to optimal nasal airflow. Any suitable solid or
expandable medical balloon material and construction available to
the skilled artisan may be used.
[0108] FIG. 4B illustrates an embodiment of a treatment element
configured to deliver energy to an interior of a nose. In some
embodiments, the treatment element of FIG. 4B also includes an
expandable balloon.
[0109] FIG. 4C illustrates an embodiment of a bifurcated treatment
element 70 having a pair of semi-ellipsoid elements 72, 74 sized
and configured to be inserted into the nose with one element 72, 74
on either side of the septum. The elements may each have a medial
surface 75a & 75b which may be substantially flat, curved or
otherwise shaped and configured to lie adjacent to (and possibly in
contact with) the nasal septum. In some embodiments, the elements
72, 74 may include expandable balloons with independent inflation
lumens 76, 78. In alternative embodiments, the elements 72, 74 have
substantially fixed non-expandable shapes. In still further
embodiments, the elements 72, 74 may include substantially
self-expandable sections. In some embodiments, the bifurcated
treatment element halves 72, 74 may also carry energy delivery
structures as described elsewhere herein. In some embodiments, the
shape of the elements 72, 74 may be modified by the operator to
impart an optimal configuration to the treated tissue. The shape
modification of elements 72, 74 can be accomplished pre-procedure
or during the procedure and can be either fixed after modification
or capable of continuous modification.
[0110] In some embodiments, a nasal septum treatment system may
also comprise a reshaping device configured to mechanically alter a
shape of soft tissue and/or cartilage in a region of the nasal
septum in order to impart a desired shape and mechanical properties
to the tissue of the walls of the nasal airway. In some embodiments
the reshaping device may be configured to reshape the nasal septum
and/or nasal valve into a shape that improves the patency of one or
both nasal valve sections at rest and during inspiration and/or
expiration. In some embodiments, the reshaping device may comprise
balloons, stents, mechanical devices, molds, external nasal strips,
spreader forceps or any other suitable structure. In some
embodiments, a reshaping device may be integrally formed with the
treatment element 32. In alternative embodiments, a reshaping
device may be provided as a separate device that may be used
independently of the treatment element 32. As described in more
detail below, such reshaping may be performed before, during or
after treatment of the nose tissue with energy, injectable
compositions or cryo-therapy.
[0111] With reference to FIGS. 4A-4C, some embodiments of treatment
elements 32 may comprise one or more inflatable or expandable
sections configured to expand from a collapsed configuration for
insertion into the nasal passageway, to an expanded configuration
in which some portion of the treatment element 32 contacts and
engages an internal surface of a nasal passageway. In some
embodiments, an expandable treatment element may comprise an
inflation lumen configured to facilitate injection of an inflation
medium into an expandable portion of the treatment element. In
alternative embodiments, an expandable treatment element may
comprise one or more segments comprising a shape-memory alloy
material which may be configured to expand to a desired size and
shape in response to a change of temperature past a transition
temperature. In some embodiments, such a temperature change may be
brought about by activating an energy-delivery (or removal) element
in the treatment element 32.
[0112] In some embodiments, the treatment element 32 may expand
with various locations on the element expanding to different
configurations or not expanding at all to achieve a desired shape
of the treatment element. In some embodiments, such expandable
treatment elements or sections may be elastic, inelastic, or
preshaped. In some embodiments, expandable treatment elements or
sections thereof may be made from shape-memory metals such as
nickel-cobalt or nickel-titanium, shape memory polymers,
biodegradable polymers or other metals or polymers. Expandable
balloon elements may be made of any elastic or inelastic expandable
balloon material.
[0113] In alternative embodiments, the treatment element 32 can act
to change the properties of the internal soft tissue of the nasal
airway in conjunction with an external treatment device of fixed or
variable shape to provide additional force to change the shape of
the nasal septum. In some embodiments, an external mold element can
be combined with an internal element.
[0114] FIGS. 5A and 5B illustrate reshaping treatment devices 80
and 90, respectively. The treatment devices 80 and 90 are
structured as clamp devices configured to engage a targeted section
of the nasal airway with either a clamping force or a spreading
force. In some embodiments, the treatment devices of FIGS. 5A and
5B may include energy delivery elements (of any type described
herein) which may be powered by a fluid lumen or cable 86.
[0115] The treatment device of FIG. 5A includes an outer clamp
member 82 and an inner clamp member 84 joined at a hinge point 85.
In some embodiments, the outer clamp member 82 may include an
outwardly-bent section 83 sized and configured to extend around the
bulk of a patient's nose when the inner clamp member may be
positioned inside the patient's nose. The inner and outer
tissue-engaging tips at the distal ends of the inner and outer
clamp members may be configured to impart a desired shape to the
nasal septum. In some embodiments, the tissue-engaging tips may be
removable to allow for sterilization and/or to allow for tips of a
wide range of shapes and sizes to be used with a single clamp
handle.
[0116] The treatment device of FIG. 5B includes an outer clamp
member 92 and an inner clamp member 94 joined at a hinge point 95.
The inner and outer tissue-engaging tips at the distal ends of the
inner and outer clamp members may be configured to impart a desired
shape to the nasal cartilage. In the illustrated embodiment, the
outer clamp member 92 includes a concave inner surface, and the
inner clamp member includes a mating convex inner surface. The
shape and dimensions of the mating surfaces may be designed to
impart a desired shape to the structures of a patient's nose. In
some embodiments, the shape of the mating surfaces may be modified
by the operator to impart an optimal configuration to the treated
tissue. The shape modification of the mating surfaces can be
accomplished pre-procedure or during the procedure and can be
either fixed after modification or capable of continuous
modification.
[0117] In some embodiments, the tissue-engaging tips may be
removable to allow for sterilization and/or to allow for tips of a
wide range of shapes and sizes to be used with a single clamp
handle.
[0118] In alternative embodiments, the devices of FIGS. 5A and 5B
may be used as spreader devices by placing both clamp tips in a
nasal passage and separating the handles, thereby separating the
distal tips. In alternative embodiments, the handles may be
configured to expand in response to a squeezing force. The shapes
of the distal tips may be designed to impart a desired shape when
used as a spreading device.
[0119] The reshaping elements of FIGS. 3-5B are generally
configured to be used once and removed from a patient's nose once a
treatment is delivered. In some embodiments, treatments may further
involve placing longer term treatment elements, such as stents,
molds, external strips, etc. for a period of time after treatment.
An example of such a stent placed within a patient's nose after
treatment is shown in FIG. 6. In some embodiments, the stent may be
configured to be removed after a therapeutically effective period
of time following the treatment. In some embodiments, such a
therapeutically effective period of time may be on the order of
days, weeks or more.
[0120] In some embodiments, the treatment element 32 may be
configured to deliver heat energy to the nasal septum. In such
embodiments, the treatment element may comprise any suitable
heating element available to the skilled artisan. For example, the
treatment element 32 may comprise electrical resistance heating
elements. In alternative embodiments, the heating element may
comprise conduits for delivering high-temperature fluids (e.g. hot
water or steam) onto the nasal tissue. In some embodiments, a
high-temperature fluid heating element may comprise flow channels
which place high-temperature fluids into conductive contact with
nasal tissues (e.g. through a membrane wall) without injecting such
fluids into the patients nose. In further embodiments, any other
suitable heating element may be provided. In further embodiments,
the treatment element 32 may comprise elements for delivering
energy in other forms such as light, laser, RF, microwave,
cryogenic cooling, DC current and/or ultrasound in addition to or
in place of heating elements.
[0121] U.S. Pat. No. 6,551,310 describes embodiments of endoscopic
treatment devices configured to ablate tissue at a controlled depth
from within a body lumen by applying radio frequency spectrum
energy, non-ionizing ultraviolet radiation, warm fluid or microwave
radiation. U.S. Pat. No. 6,451,013 and related applications
referenced therein describe devices for ablating tissue at a
targeted depth from within a body lumen. Embodiments of
laser-treatment elements are described for example in U.S. Pat. No.
4,887,605, among others. U.S. Pat. No. 6,589,235 teaches methods
and device for cartilage reshaping by radiofrequency heating. U.S.
Pat. No. 7,416,550 also teaches methods and devices for controlling
and monitoring shape change in tissues, such as cartilage. The
devices described in these and other patents and publications
available to the skilled artisan may be adapted for use in treating
portions of a nasal septum or adjacent tissue as described herein.
U.S. Pat. Nos. 7,416,550, 6,589,235, 6,551,310, 6,451,013 and
4,887,605 are hereby incorporated by reference in their entireties
for any and all purposes.
[0122] In alternative embodiments, similar effects can be achieved
through the use of energy removal devices, such as cryogenic
therapies configured to transfer heat energy out of selected
tissues, thereby lowering the temperature of targeted tissues until
a desired level of tissue modification is achieved. Examples of
suitable cryogenic therapy delivery elements are shown and
described for example in U.S. Pat. Nos. 6,383,181 and 5,846,235,
the entirety of each of which is hereby incorporated by reference
for any and all purposes.
[0123] In some embodiments, the treatment element 32 may be
configured to deliver energy (e.g. heat, RF, ultrasound, microwave)
or cryo-therapy uniformly over an entire outer surface of the
treatment element 32, thereby treating all nasal tissues in contact
with the treatment element 32. Alternatively, the treatment element
32 may be configured to deliver energy at only selective locations
on the outer surface of the treatment element 32 in order to treat
selected regions of nasal tissues. In such embodiments, the
treatment element 32 may be configured so that energy being
delivered to selected regions of the treatment element can be
individually controlled. In some embodiments, portions of the
treatment element 32 are inert and do not deliver energy to the
tissue. In further alternative embodiments, the treatment element
32 may be configured with energy-delivery (or removal) elements
distributed over an entire outer surface of the treatment element
32. The control system 42 may be configured to engage such
distributed elements individually or in selected groups so as to
treat only targeted areas of the nasal passageway.
[0124] In some embodiments, the treatment element 32 may be a
balloon with energy delivery elements positioned at locations where
energy transfer is sufficient or optimal to effect change in
breathing. Such a balloon may be configured to deliver energy while
the balloon is in an inflated state, thereby providing a dual
effect of repositioning tissue and delivering energy to effect a
change the nasal septum. In other embodiments, a balloon may also
deliver heat by circulating a fluid of elevated temperature though
the balloon during treatment. The balloon can also deliver
cryotherapy (e.g., by circulating a low-temperature liquid such as
liquid nitrogen) while it is enlarged to increase the nasal valve
diameter or otherwise alter the shape of a nasal septum. FIG. 7
illustrates an example of an energy-delivery balloon being inserted
into a patient's nose for treatment. Several embodiments may be
employed for delivering energy treatment over a desired target
area. For example, in some embodiments, a laser treatment system
may treat a large surface area by scanning a desired treatment
pattern over an area to be treated. In the case of microwave or
ultrasound, suitably configured transducers may be positioned
adjacent to a target area and desired transducer elements may be
activated under suitable depth focus and power controls to treat a
desired tissue depth and region. In some embodiments, ultrasound
and/or microwave treatment devices may also make use of lenses or
other beam shaping of focusing devices or controls. In some
embodiments, one or more electrical resistance heating elements may
be positioned adjacent to a target region, and activated at a
desired power level for a therapeutically effective duration. In
some embodiments, such heating elements may be operated in a
cyclical fashion to repeatedly heat and cool a target tissue. In
other embodiments, RF electrodes may be positioned adjacent to and
in contact with a targeted tissue region. The RF electrodes may
then be activated at some frequency and power level therapeutically
effective duration. In some embodiments, the depth of treatment may
be controlled by controlling a spacing between electrodes. In
alternative embodiments, RF electrodes may include needles which
may puncture a nasal septum tissue to a desired depth (as shown for
example in FIG. 4D and in other embodiments below).
[0125] In some embodiments, the treatment element 32 and control
system 42 may be configured to deliver treatment energy or
cryotherapy to a selected tissue depth in order to target treatment
at specific tissues. For example, in some embodiments, treatments
may be targeted at tightening sections of the epithelium of the
nasal septum. In other embodiments, treatments may be targeted at
strengthening soft tissues underlying the epithelium. In further
embodiments, treatments may be targeted at strengthening cartilage
in the area of the nasal valve and/or upper lateral cartilage. In
still further embodiments, treatments may be targeted at
stimulating or modifying the tissue of muscles of the nose or face
in order to modify the nasal septum.
[0126] In some embodiments, the treatment element 32 and control
system 42 may be configured to deliver treatment energy to create
specific localized tissue damage or ablation, stimulating the
body's healing response to create desired conformational or
structural changes in the nasal tissue.
[0127] In some embodiments, a treatment element may be configured
to treat a patient's nasal septum by applying treatment (e.g.,
energy, cryotherapy, or other treatments) from a position outside
the patient's nose. For example, in some embodiments, the devices
of FIGS. 5A and 5B may be configured to apply energy from an
element positioned outside a patient's nose, such as on the skin.
In another embodiment, a device may be placed on the external
surface of the nose that would pull skin to effect a change in the
nasal airway. Treatment may then be applied to the internal or
external nasal tissue to achieve a desired nasal septum
configuration.
[0128] In some embodiments, the device is configured to position
tissue to be reshaped. In some embodiments, the device comprises
features and mechanisms to pull, push or position the nasal tissue
into a mold for reshaping. For example, suction, counter traction,
or compression between two parts of the device may be used.
[0129] In some embodiments, the treatment device comprises one,
two, three, four, or more molds configured to reshape tissue. The
mold or reshaping element may be fixed in size or may vary in size.
The mold may also be fixed in shape or may vary in shape. For
example, the size or shape of the element may be varied or adjusted
to better conform to a nasal septum of a patient. Adjustability may
be accomplished using a variety of means, including, for example,
mechanically moving the mold by way of joints, arms, guidewires,
balloons, screws, stents, and scissoring arms, among other means.
The mold may be adjusted manually or automatically. The mold is
configured to impart a shape to the tissues of the nasal septum
area to improve airflow or perceived airflow.
[0130] In some embodiments, the mold or reshaping element comprises
a separate or integrated energy delivery or treatment element
(e.g., an electrode such as those described below with respect to
FIGS. 8A-8J). The treatment element may be fixed or adjustable in
size. For example, the treatment element may be adjusted to better
conform to the nasal septum of a patient. In the case of a separate
reshaping element and treatment element, a distance between the two
elements may either be fixed or adjustable. Adjustability may be
accomplished using a variety of means, including, for example,
mechanically moving the mold by way of joints, arms, guidewires,
balloons, screws, stents, and scissoring arms, among other
means.
[0131] In some embodiments, the mold or another part of the device
is configured to deliver cooling (discussed in more detail below).
In some embodiments, the mold or reshaping element comprises a
balloon configured to reshape and/or deform tissue. A balloon may
also be configured to deliver energy such as heat using hot liquid
or gas.
Examples of Various Electrode Arrangements
[0132] Described below are embodiments of various treatment devices
and, more particularly, electrode arrangements that may be used for
applying energy to tissue, such as hyaline cartilage of the nasal
septum area. These electrodes may, for example, deliver RF energy
to preferentially shape the tissue to provide improved nasal
breathing. In some embodiments, one or more electrodes may be used
alone or in combination with a tissue shaping device or mold. In
other embodiments, one or more electrodes may be integrally formed
with a tissue shaping device or mold, so that the electrodes
themselves create the shape for the tissue. In some embodiments,
the energy delivery devices may use alternating current. In some
embodiments, the energy delivery devices may use direct current. In
certain such embodiments, the energy delivery device may comprise a
configuration utilizing a grounding pad.
[0133] In some embodiments, the term "electrode" refers to any
conductive or semi-conductive element that may be used to treat the
tissue. This includes, but is not limited to metallic plates,
needles, and various intermediate shapes such as dimpled plates,
rods, domed plates, etc. Electrodes may also be configured to
provide tissue deformation in addition to energy delivery. Unless
specified otherwise, electrodes described can be monopolar (e.g.,
used in conjunction with a grounding pad) or bipolar (e.g.,
alternate polarities within the electrode body, used in conjunction
with other tissue-applied electrodes).
[0134] In some embodiments, "mold", "tissue shaper", "reshaping
element" and the like refer to any electrode or non-electrode
surface or structure used to shape, configure or deflect tissue
during treatment.
[0135] In some embodiments, "counter-traction" refers to applying a
force opposite the electrode's primary force on the tissue to
increase stability, adjustability, or for creating a specific
shape.
[0136] As shown in FIG. 8A, in some embodiments, bipolar electrodes
may be used to deliver energy, with one electrode 202 placed
internally in the nose, for example against the nasal septum, and
one electrode 204 placed externally on the outside of the nose.
This embodiment may advantageously provide direct current flow
through the tissue with no physical trauma from needles (as shown
in some embodiments below). As shown in FIG. 8B, in some
embodiments, bipolar electrodes may be used to deliver energy, with
both electrodes 210, 212 placed internally. An insulating spacer
214 may be placed between them. This embodiment may be simple and
may advantageously minimize current flow through the skin layer. In
some embodiments, bipolar electrodes 220, 222 may be both placed
externally and may be connected to a passive molding element 224
placed inside the nasal septum adjacent to tissue to be treated, as
shown in FIG. 8C. This embodiment may advantageously minimize the
potential for mucosal damage. In some embodiments, electrodes
placed internally may be shaped to function as a mold or may
comprise an additional structure that may function as a mold.
[0137] In some embodiments, a monopolar electrode may be used to
deliver energy. As shown in FIG. 8D, the electrode 230 may be
placed internally and may be connected to an external, remote
grounding pad 232. The grounding pad 232 may, for example, be
placed on the abdomen of a patient or in other desired locations.
This embodiment may advantageously be simple to manufacture and may
minimize current flow through the skin. In some embodiments, a
monopolar electrode may be placed externally and may be connected
to a molding element placed at the nasal septum as well as a remote
grounding pad. This embodiment may also advantageously be simple to
manufacture, may minimize mucosal current flow, and may also be
simple to position. In some embodiments, electrodes placed
internally may be shaped to function as a mold or may comprise an
additional structure that may function as a mold.
[0138] In some embodiments, monopolar transmucosal needles may be
used to deliver energy. The needle electrodes 240 may be placed
internally, as shown in FIG. 8E penetrating through the mucosa to
the cartilage, and a remote grounding pad 242 or element may be
placed externally. In some embodiments, monopolar transmucosal
needles may be used in conjunction with one or more molding
elements which may be disposed on or around the needles. In some
embodiments, monopolar transdermal needles may be used to deliver
energy. In other embodiments (not shown), the needles may be placed
external to the nose, and penetrate through to tissue to be
treated. Needle configurations may advantageously target the
cartilage tissue to be treated specifically. The monopolar
transdermal needles may be used in conjunction with an internal
molding device (not shown).
[0139] In some embodiments, bipolar transmucosal needles may be
used to deliver energy to tissue to be treated. The needles may be
placed internally, with an insulating spacer between them and may
penetrate through the mucosa to the cartilage to be treated. In
some embodiments, the bipolar transmucosal needles may be used in
combination with one or more internal molding elements. The one or
more molding elements may be placed on or near the needles. In some
embodiments, bipolar transdermal needles may be used to deliver
energy. In other embodiments, the transdermal needles may be placed
externally and penetrate through to tissue to be treated. Needle
configurations may advantageously target the cartilage tissue to be
treated specifically. The transdermal bipolar needles may be used
in conjunction with an internal molding element.
[0140] As shown in FIG. 8F, in some embodiments, an array of
electrodes comprising one, two, or many pairs of bipolar needles
252 are located on a treatment element configured to be placed into
contact with the cartilage. An insulator 254 may be disposed
between the bipolar needles 252. An insulator may also be used on
part of the needle's length to allow energy to be delivered only to
certain tissue structures, such as cartilage. The electrodes may be
placed either internally or transmucosally or they may be placed
externally or transdermally. In the embodiment illustrated in FIG.
8F, the insulator 254 may also function as a mold or molding
element. In other embodiments (not shown), the array of electrodes
is used in conjunction with a separate tissue reshaping
element.
[0141] FIG. 8G illustrates another embodiment of a treatment
element comprises one, two or many pairs of bipolar electrodes 260.
As opposed to FIG. 8F, where the pairs of electrodes are arranged
side-by-side, the embodiment of FIG. 8G arranges the pairs of
electrodes along the length of the treatment element. The
electrodes of FIG. 8G are also non-penetrating, in contrast to the
needles of FIG. 8F. The electrodes 260 may be placed against either
the skin, externally, or the mucosa, internally as a means of
delivering energy to target tissue such as cartilage.
[0142] In some embodiments of treatment devices comprising an array
or multiple pairs of electrodes, each pair of electrodes (bipolar)
or each electrode (monopolar) may have a separate, controlled
electrical channel to allow for different regions of the treatment
element to be activated separately. For example, the needles or
needle pairs of FIG. 8F may be individually controlled to produce
an optimal treatment effect. For another example, the separate
electrodes of FIGS. 8B and 8C may be individually controlled to
produce an optimal treatment effect. Other examples are also
contemplated. The channels may also comprise separate or integrated
feedback. This may advantageously allow for more accurate
temperature control and more precise targeting of tissue. Separate
control may also allow energy to be focused and/or intensified on a
desired region of the treatment element in cases where the anatomy
of the nasal tissue/structures does not allow the entire electrode
region of the treatment element to engage the tissue. In such
embodiments, the nasal tissue that is in contact with the treatment
element may receive sufficient energy to treat the tissue.
[0143] Combinations of the described electrode configurations may
also be used to deliver energy to tissue to be treated (e.g., by
being reshaped). For example, transmucosal needles 264 may be
placed internally, penetrating through to the tissue to be treated,
and an electrode 266 may be placed externally or on an opposite
side of the tissue to be treated, as shown in FIG. 8H. This
embodiment may advantageously target the cartilage tissue
specifically and be biased for mucosal preservation. For another
example, transdermal needles 268 may be inserted on an opposite
side of the nasal septum from an electrode 270, as shown in FIG.
8I. This embodiment may advantageously target the cartilage tissue
specifically and be biased towards mucosal preservation. For
another example bipolar needle electrodes 272, 274 can be placed on
both sides of tissue to be treated, as shown in FIG. 8J. This
embodiment may advantageously target the cartilage tissue
specifically. Some embodiments of treatment elements may include
inert areas which do not delivery energy to the tissue. Other
combinations of electrode configuration are also possible.
Examples of Treatment Devices Including Electrodes
[0144] Embodiments of treatment devices incorporating treatment
elements such as the electrodes described above are illustrated in
FIGS. 9A-21B. The instrument designs described in these embodiments
may be used in a device such as the device 30, described above, and
in the system of FIG. 3. In some embodiments, the devices provide
tissue reshaping or molding in addition to energy delivery.
Applying energy to the nasal tissue may require properly
positioning the electrode(s) at the nasal septum, deflecting or
deforming the tissue into a more functional shape, and delivering
or applying energy consistently prior to device removal.
Embodiments described herein may advantageously provide
adjustability, visualization of effect, ease of use, ease of
manufacturability and component cost. Molding and reshaping of the
tissues of the nose may allow for non-surgical nasal breathing
improvement without the use of implants.
[0145] FIG. 9A depicts a device 300 comprising a single inter-nasal
monopolar electrode 301 located at the end of a shaft 302. The
shaft is attached to a handle 303. The electrode configuration may
be similar to that described with respect to FIG. 8D. FIG. 9B
depicts another device 304 comprising a single inter-nasal,
monopolar electrode 305. The electrode 305 is located at the distal
end of a shaft 306, which is attached to a handle 307. The handle
comprises a power button 308 that may be used to activate and
deactivate the electrode. As stated above, the device 304 may
either comprise a generator or be connected to a remote generator.
The electrode 305 may be provided on an enlarged, distal end of the
shaft 306, and in the embodiment illustrated has a convex shape
configured to press against and create a concavity in the nasal
cartilage.
[0146] FIG. 10A depicts a side view of a device 310 comprising a
single inter-nasal electrode 312 located at the end of a shaft 314.
The shaft is attached to a handle 316. An external mold 318 is
attached to the handle 316 and can be moved relative to the
electrode shaft 314. The external mold 318 has a curved shape with
an inner concave surface that may be moved in order to press
against an external surface of a patient's nose to compress tissue
between the external mold 318 and the electrode 312. FIG. 10B
provides a front view of the device 310.
[0147] FIG. 11A depicts a device 320 comprising a single
inter-nasal electrode 322 attached to the end of a shaft 324. The
shaft 324 is attached to a handle 326. An internal shaft 328
comprising a tissue-contacting surface is attached to the handle
326. The internal shaft 328 can be moved relative to the electrode
shaft 324 and may provide counter-traction and/or positioning. For
example, when the electrode 322 is placed against a patient's nasal
septum, the counter-traction element 328 may be pressed against the
patient's upper or lower lateral cartilage.
[0148] FIG. 11B depicts a device 450 similar to device 320 of FIG.
11A comprising an inter-nasal electrode 451 located at a distal end
of a shaft 452 connected to a handle 454. The device 450 further
comprises a counter-traction element 456 connected to a handle 458.
Like the device 320 depicted in FIG. 11A, the connection 460
between the two handles 454, 458 is such that squeezing the two
handles 454, 458 together causes the electrode 451 and the
counter-traction element 456 to move away from each other,
spreading the tissue they are contacting.
[0149] FIG. 12A depicts a device 330 comprising a single
inter-nasal electrode 332 located at the end of a shaft 334. The
shaft 334 is attached to a handle 336. The device 330 comprises
another single inter-nasal electrode 338 attached to the end of a
shaft 340. The shaft 340 is attached to a handle 342. The device
comprises a connection 344 between the two handles 336, 342 that
allows simultaneous deformation and treatment of both nostrils.
[0150] FIG. 12B depicts a device 470 similar to device 330 of FIG.
12A comprising a first inter-nasal electrode 472 located at a
distal end of a shaft 474 connected to a handle 476. The device 470
comprises a second inter-nasal electrode 478 located at a distal
end of a second shaft 480 connected to a second handle 482. The
connection 484 between the two handles 476, 482 is such that
squeezing the handles 476, 482 together causes the electrodes 472,
478 to move together, compressing tissue therebetween. The device
470 comprises a ratcheting mechanism 475 between the two handles
476, 482 that allows the relative positions of the electrodes 472,
478 to be locked during treatment.
[0151] FIG. 13A depicts a side view of a device 350 also used for
treating two nostrils comprising an inter-nasal electrode 352
attached to the end of a shaft 354. The shaft 354 is attached to a
handle 356. As seen in the front view provided in FIG. 13B, the
device 350 comprises a second inter-nasal electrode 358. The second
inter-nasal electrode 358 is attached to the end of a shaft which
is attached to a handle. A connection between the two handles
allows simultaneous deformation and treatment of the nostrils. An
external mold 366 is attached to the handles. The mold 366 may be
moved relative to the electrode shafts 354, 360 and may provide
counter-traction (e.g., against the bridge of the nose) and
positioning.
[0152] FIGS. 13C-E depicts a device 490 similar to the device 350
shown in FIG. 13A and FIG. 13B. FIGS. 13C and 13D depict side and
top views of a device 490 comprising a handle 492. The handle 492
bifurcates into a first shaft 494 with a first inter-nasal
electrode 496 located at a distal end of the shaft 494 and a second
shaft 498 with a second inter-nasal electrode 500 located at a
distal end of the shaft 498. The device 490 comprises a mold 502
configured to provide counter-traction or compression of the bridge
of the nose. The mold 502 comprises a handle 504. The connection
506 between the handles 492, 504 is such that squeezing the two
handles 492, 504 causes the electrodes 496, 500 and the mold 502 to
be compressed together. FIG. 13E depicts the device 490 being used
on a patient. The arrows indicate the directions in which the
handles 492, 504 are configured to be squeezed.
[0153] FIG. 14A depicts a front view of a device 370 comprising an
inter-nasal electrode 372 attached to the end of a shaft 374 (shown
in top view of FIG. 14B). The shaft 374 is attached to a handle
376. The device 370 comprises a second inter-nasal electrode 378
attached to the end of a second shaft 380. The second shaft 380 is
attached to a second handle 382. A connection 384 between the two
handles 376, 382 may allow simultaneous deformation and treatment
of the nostrils. External molds 386, 388 are attached to the
handles and can be moved relative to each electrode shaft 374, 380.
The molds 386, 388 may provide counter-traction, compression of
tissue, positioning, and external tissue deformation.
[0154] FIG. 15A depicts a front view of device 390 comprising a
first inter-nasal electrode 392 and a second inter-nasal electrode
398. As shown in the side view of FIG. 15B, the device 390
comprises a first inter-nasal electrode 392 attached to the end of
a shaft 394. The shaft is attached to a handle 396. A second
inter-nasal electrode 398 is attached to the end of a second shaft
400, as shown in the top view of FIG. 15C. The second shaft 400 is
attached to a second handle 402. A connection 404 between the two
handles 396, 402 may allow simultaneous deformation and treatment
of the nostrils. Additional internal shafts 406, 408 comprise
tissue-contacting surfaces and are attached to the handles 396,402.
The internal shafts 406, 408 may be moved relative to each
electrode shaft 394, 400 (shown in FIG. 15B) and may provide
counter-traction and positioning.
[0155] FIG. 16 depicts a system 410 comprising a first device
having an extra-nasal electrode 412 along a concave surface
configured to be positioned against an external surface of a
patient's nose, the electrode 412 being attached to the end of a
shaft 414. The shaft 414 is attached to a handle 416. A separate
device 417 comprising an internal tissue mold 418 is attached to a
shaft 420. The internal tissue mold is configured to be positioned
inside the patient's nose. The shaft 420 is attached to a handle
422. Each handle 422, 416 may be manipulated individually and may
apply energy and deformation to create a desired tissue effect.
[0156] FIG. 17A depicts a side view of a device 430 comprising an
extra-nasal electrode 431 attached to the end of a shaft 432. The
shaft 432 is attached to a handle 434. The device 430 also
comprises an internal tissue mold 436 attached to a shaft 438 which
is attached to a handle 440. The handles 434, 440 are attached
together and may be moved relative to each other to simultaneously
deliver energy and deform tissue. FIG. 17B depicts a front view of
the device 430.
[0157] FIG. 18 depicts a device 390 comprising pairs of bipolar
electrodes 392 located at the distal end of a shaft 394. The
electrodes may be similar to the electrodes described with respect
to the electrode configuration of FIG. 8G in that they are
non-penetrating. The shaft 394 is connected to a handle 398 which
comprises a button 395 configured to activate and deactivate the
electrodes. As stated above, the device 390 may either comprise a
generator or be connected to a remote generator.
[0158] FIG. 19A depicts the treatment element 503 of a treatment
device (e.g., device 30). The treatment element 503 of the device
comprises a monopolar electrode 505. A cross-section of the
treatment element 503 is shown in FIG. 19B. It comprises an
asymmetrical shape and has a convex surface where the electrode is
positioned configured to conform to only one of a patient's
nostrils (for example, a patient's right nostril). More
specifically, the convex surface is configured such that when
inserted into the particular nostril, the convex surface would be
located adjacent the nasal septum. The treatment element 503
further comprises a light 507 configured to illuminate the
treatment area. For example an LED or a visible laser may be used.
The visible laser may experience less diffusion in the tissue.
Furthermore, the light 507 can be situated such that light can be
transmitted through the nasal tissue (including the skin) and can
be visualized externally by the user. The user can then use the
light to properly position the device in the desired location.
Because the electrode 505 is not centered on the treatment element
503 of the device, a separate device having a mirror-image
configuration may be required to treat the other nostril.
[0159] FIG. 20A depicts the treatment element 512 of a treatment
device (e.g., device 30). The treatment element 512 of the device
comprises two monopolar electrodes 514, 516 provided side-by-side
on a convex surface of the treatment element. The cross section of
the treatment element 512, shown in FIG. 20B, is configured to
conform to the shape either nostril, depending on which side of the
device (and accordingly, which of electrode 514 or 516) is placed
in contact with the patient's nasal septum. Monopolar electrodes
514, 516 may allow the same treatment element 512 to be used for
treatment in both nostrils, and each electrode may be activated
separately depending on which side needs to be used. The treatment
element 512 also comprises two lights 518, 520 (e.g., LEDs, lasers)
configured to illuminate the treatment area for both nostrils. One
or both of the lights 518, 520 can also be situated such that light
can be transmitted through the nasal tissue (including the skin)
and can be visualized externally by the user. The user can then use
the light to properly position the device in the desired
location.
[0160] FIG. 21A depicts a treatment element 522 of a treatment
device (e.g., device 30). The tip 522 of the device comprises a
monopolar electrode 524. The tip 522 comprises a symmetrical
cross-section as shown in FIG. 21B. The tip 522 comprises a light
526 (e.g., LED) configured to illuminate the treatment area. The
light 526 can also be situated such that light can be transmitted
through the nasal tissue (including the skin) and can be visualized
externally by the user. The symmetrical tip allows the user to
treat either left or right nostril. The user can then use the light
to properly position the device in the desired location.
[0161] FIGS. 22A-G depict a treatment device 530 similar to the
embodiments of FIGS. 8D, 9A, and 9B. FIGS. 22A and 22F provide
perspective views of the device 530. The device 530 comprises a
treatment element 532 at its distal tip 534. The treatment element
532 comprises an electrode 535. The body of the treatment element
532, itself, may comprise an insulating material. The treatment
element 532 may be provided on an enlarged distal tip 534 of an
elongate shaft 536, and as in the embodiment illustrated, may have
a convex shape configured to press against and create a concavity
in the nasal cartilage (e.g., in the cartilage of the nasal
septum). The distal tip 534 is located at the distal end of shaft
536. The shaft is attached at its proximal end to a handle 538. The
handle 538 comprises an input control such as a power button 540 on
its front side that may be used to activate and deactivate the
electrode. The power button 540 may be positioned in a recess of
the handle to allow for finger stability when activating and
deactivating the electrode. In other embodiments, the input control
is in the form of a switch or dial. Other configurations are also
possible as described above.
[0162] The device 530 comprises a flexible wire or cable 542
electrically connected to an adaptor 544. The adaptor 544 can be
used to connect the device 530 to a remote generator (not shown).
The adaptor 544 may allow transmission of treatment energy between
a remote generator and the device 530. The adaptor may also allow
transmission of any sensor signals between the device 530 and a
generator or control unit. The device 530 may either comprise an
integrated generator or be connected to a remote generator. The
treatment device 530 may be provided in a system or kit also
including the remote generator. The system or kit (with or without
the remote generator) may also include a grounding device and/or a
cooling device as described above and further below. In some
embodiments, the kit includes a positioning element (e.g., a
"cottle" device) configured to help a user locate the optimal
treatment area.
[0163] FIGS. 22B and 22C depict front and back views of the device.
As shown in FIGS. 22B and 22C, the handle 538 of the device
generally as a rounded elongate shape. Other shapes are also
possible. For example the device 530 may have a square shaped cross
section. In some embodiments, a circumference (or width or
cross-sectional area) of the handle 538 may increase distally along
the length of the handle 538.
[0164] FIGS. 22D and 22E depict side views of the device. As shown
in FIGS. 22D and 22E, the handle 538 of the device 530 may comprise
an indentation or recess around the middle of the handle 538. This
may allow for enhanced grip and control when a user is holding the
device. The indentation or recess may be near the input control or
power button 540 to allow a user to easily activate and deactivate
the device while holding it in a comfortable position.
[0165] In some embodiments, the shaft has a width or diameter of
about 0.125 inches to about 0.25 inches. In some embodiments, the
shaft is about 1.5 inches to about 4 inches long. In some
embodiments, the shaft comprises a polymer such as polycarbonate or
PEEK. In other embodiments, the shaft comprises stainless steel or
other metals. The metals may be coated with an external and/or
internal insulating coating (e.g., polyester, polyolefin, etc.).
The handle may comprise the same material as the shaft, in some
embodiments. In some embodiments, the shaft is rigid. This may
allow a user of the device increased control over the deformation
of nasal tissue. In some embodiments, the shaft comprises some
amount of flexibility. This flexibility may allow a user adjust an
angle of the distal tip by bending the distal end of the shaft.
[0166] FIG. 22G depicts a larger view of the distal tip 534 of the
device 530. As shown best in FIG. 22G, the treatment element 532
comprises a generally elongate shape. The front of the treatment
element 532 comprises a shallow, curved surface, providing a convex
shape configured to deform the nasal tissue and create a concavity
therein. In some embodiments, the front of the treatment element
comprises a concave shape. The shape of the front surface of the
treatment element may be selected to conform to the nasal tissue.
The back of the treatment element 532 also comprises a shallow
curved surface. As best seen in FIGS. 22D and 22E, the back surface
varies in width along the length of the back surface of the
treatment element 532. The back surface widens, moving distally
along the tip until it is nearly in line with the proximal end of
the electrode plate 535. The back surface then narrows towards the
distal tip of the treatment element 532. This shape may maximize
visualization of the area to be treated, while, at the same time,
providing sufficient rigidity for treatment. Other shapes are also
possible. For example, the treatment element may comprise a
generally spherical or cylindrical shape. In some embodiments, the
treatment element comprises an angular shape (e.g., triangular,
conical) which may allow for close conformation to the tissue
structures. The treatment element 532 comprises a monopolar
electrode plate 535. The monopolar electrode plate 535 can be in
the shape of a rectangle having a curved or convex tissue-facing
surface. Other shapes are also possible (e.g., square, circular,
ovular, etc.). The electrode 535 may protrude slightly from the
treatment element 532. This may allow the electrode to itself
provide a convex shape configured to create a concavity in tissue
to be treated.
[0167] In some embodiments, the treatment element has a width or
diameter of about 0.25 inches to about 0.45 inches. In some
embodiments, the treatment element is about 0.4 inches to about 0.5
inches long. The treatment element can, in some embodiments,
comprise a ceramic material (e.g., zirconium, alumina, silicon
glass). Such ceramics may advantageously possess high dielectric
strength and high temperature resistance. In some embodiments, the
treatment element comprises polyimides or polyamides which may
advantageously possess good dielectric strength and elasticity and
be easy to manufacture. In some embodiments, the treatment element
comprises thermoplastic polymers. Thermoplastic polymers may
advantageously provide good dielectric strength and high
elasticity. In some embodiments, the treatment element comprises
thermoset polymers, which may advantageously provide good
dielectric strength and good elasticity. In some embodiments, the
treatment element comprises glass or ceramic infused polymers. Such
polymers may advantageously provide good strength, good elasticity,
and good dielectric strength.
[0168] In some embodiments, the electrode has a width of about 0.15
inches to about 0.25 inches. In some embodiments, the electrode is
about 0.2 inches to about 0.5 inches long. In some embodiments, the
treatment element comprises steel (e.g., stainless, carbon, alloy).
Steel may advantageously provide high strength while being low in
cost and minimally reactive. In some embodiments, the electrodes or
energy delivery elements described herein comprise materials such
as platinum, gold, or silver. Such materials may advantageously
provide high conductivity while being minimally reactive. In some
embodiments, the electrodes or energy delivery elements described
herein comprise anodized aluminum. Anodized aluminum may
advantageously be highly stiff and low in cost. In some
embodiments, the electrodes or energy delivery elements described
herein comprise titanium which may advantageously possess a high
strength to weight ratio and be highly biocompatible. In some
embodiments, the electrodes or energy delivery elements described
herein comprise nickel titanium alloys. These alloys may
advantageously provide high elasticity and be biocompatible. Other
similar materials are also possible.
[0169] As shown in the embodiment of FIG. 22G, the treatment
element 532 further comprises a pin-shaped structure comprising a
thermocouple 533 within an insulating bushing extending through a
middle portion of the plate 532. In some embodiments, different
heat sensors (e.g., thermistors) may be used. In some embodiments,
the thermocouple 533 is configured to measure a temperature of the
surface or subsurface of tissue to be treated or tissue near the
tissue to be treated. A pin-shape having a sharp point may allow
the structure to penetrate the tissue to obtain temperature
readings from below the surface. The thermocouple can also be
configured to measure a temperature of the treatment element 532
itself. The temperature measurements taken by the thermocouple can
be routed as feedback signals to a control unit (e.g., the control
system 42 described with respect to FIG. 3) and the control unit
can use the temperature measurements to adjust the intensity of
energy being delivered through the electrode. In some embodiments,
thermocouples or other sensing devices may be used to measure
multiple tissue and device parameters. For example, multiple
thermocouples or thermistors may be used to measure a temperature
at different locations along the treatment element. In some
embodiments, one of the sensors may be configured to penetrate
deeper into the tissue to take a measurement of a more interior
section of tissue. For example, a device may have multiple sensors
configured to measure a temperature at the mucosa, the cartilage,
and/or the treatment element itself. As described above, in some
embodiments, the sensors described herein are configured to take a
measurement of a different parameter. For example, tissue impedance
can be measured. These measurements can be used to adjust the
intensity and/or duration of energy being delivered through the
treatment element. This type of feedback may be useful from both an
efficacy and a safety perspective.
[0170] As shown in FIG. 22G, in some embodiments the thermocouple
is within a pin shaped protrusion on the surface of the electrode
532. In other embodiments, the thermocouple can simply be on the
surface of the electrode. In other embodiments, the thermocouple
can protrude from the surface of the electrode in a rounded
fashion. Rounded structures may be pressed into the tissue to
obtain subsurface temperature readings. Other configurations and
locations for the thermocouple are also possible. The use of
thermocouples or temperature sensors may be applied not only to the
embodiment of FIG. 22G, but also to any of the other embodiments
described herein.
[0171] FIGS. 23A-G depict a treatment device 550 similar to the
embodiments of FIGS. 8F and 18. FIGS. 23A and 23F are perspective
views of the device 550 and show the device 550 comprising a
treatment element 552 at the distal tip 556 of the device 550. The
treatment element 552 may be provided on an enlarged distal tip 556
of an elongate shaft 558, and as in the embodiment illustrated, may
have a convex shape configured to press against and create a
concavity in the nasal cartilage (e.g., in cartilage of the nasal
septum). The distal tip 556 is located at a distal end of shaft
558. The shaft is attached at its proximal end to a handle 560. The
handle 560 comprises an input control, such as a power button 562,
on its front side that may be used to activate and deactivate the
electrode. The power button may be positioned in a recess of the
handle to allow for finger stability when activating and
deactivating the electrode. In other embodiments, the input control
is in the form of a switch or dial. Other configurations are also
possible as described above. The device 550 may either comprise a
generator or be connected to a remote generator. The device 550 may
comprise a flexible wire or cable 564 that connects to an adaptor
566 that is configured to be plugged into a remote generator (not
shown). The adaptor 566 may allow transmission of treatment energy
between a remote generator and the device 550. The adaptor 566 may
also allow transmission of any sensor signals between the device
550 and a generator or control unit. The treatment device 550 may
be provided in a system or kit also including the remote generator.
The system or kit (with or without the remote generator) may also
include a grounding device and/or a cooling device as described
above and further below. In some embodiments, the kit includes a
positioning element (e.g., a "cottle" device) configured to help a
user locate the optimal treatment area.
[0172] In some embodiments, the shaft has a width or diameter or
about 0.235 inches to about 0.25 inches. In some embodiments, the
shaft is about 1.5 inches to about 4 inches long. In some
embodiments, the shaft and/or handle comprises a polymer such as
polycarbonate or PEEK. In other embodiments, the shaft comprises
stainless steel or other metals. The metals may be coated with an
external and/or internal insulating coating (e.g., polyester,
polyolefin, etc.). The handle may comprise the same material as the
shaft, in some embodiments. In some embodiments, the shaft is
rigid. This may allow a user of the device increased control over
the deformation of nasal tissue. In some embodiments, the shaft
comprises some amount of flexibility. This flexibility may allow a
user adjust an angle of the distal tip by bending the distal end of
the shaft.
[0173] FIGS. 23B and 23C depict side views of the device. As shown
in FIGS. 23B and 23C, the handle 560 of the device 550 may comprise
an indentation or recess around the middle of the handle 560. This
may allow for enhanced grip and control when a user is holding the
device. The indentation or recess may be near the input control or
power button 562 to allow a user to easily activate and deactivate
the device while holding it in a comfortable position.
[0174] FIGS. 23D and 23E depict front and back views of the device.
As shown in FIGS. 23D and 23E, the handle 560 of the device
generally comprises a rounded elongate shape. Other shapes are also
possible. For example the device 550 may have a square shaped cross
section. In some embodiments, a circumference (or width or
cross-sectional area) of the handle 560 may increase distally along
the length of the handle 560.
[0175] FIG. 23G depicts a larger view of the distal tip 556 of the
device 550. As shown best in FIG. 23G, the treatment element 552
comprises a generally elongate shape. The front of the treatment
element 552 comprises a shallow curved surface, providing a convex
shape configured to deform the nasal tissue and create a concavity
therein. In some embodiments, the front of the treatment element
comprises a concave shape. The shape of the front surface of the
treatment element may be selected to conform to the nasal tissue.
The back surface of the treatment element 552 comprises a shallow
curved surface along most of its length. As best seen in FIGS. 23B
and 23C, the back surface narrows distally along the length of the
element 552 from approximately the distal end of the needle
electrodes to the distal tip of the treatment element 552. This
shape may maximize visualization of the area to be treated, while,
at the same time, providing sufficient rigidity for treatment.
Other shapes are also possible. For example, the treatment element
may comprise a generally spherical or cylindrical shape. In some
embodiments, the treatment element comprises an angular shape
(e.g., triangular, conical) which may allow for close conformation
to the tissue structures. The treatment element 552 comprises a
monopolar or bipolar needle array comprising multiple needles 554.
In some embodiments, the needles 554 are energized in between
select needles to deliver bipolar energy. In other embodiments, the
energy is delivered between the needles 554 and a remote grounding
pad (not shown). In some embodiments, the electrode needle pairs
are arranged horizontally across the treatment element 552. In some
embodiments, the electrode needle pairs are arranged vertically
across the treatment element 552, or along the direction of the
shaft 558 and handle 560. Other configurations are also possible.
For example, the needle pairs may be arranged diagonally across the
treatment element 552. The treatment element 552 may be placed
either internally, with the needle pairs 554 positioned
transmucosally or the treatment element 552 may be placed
externally with the needle pairs 554 positioned transdermally. The
distal tip 556 of the device 550 may also function as a mold or
molding element. In a monopolar embodiment, the energy may be
selectively delivered between certain sets of needles, all needles,
or even individual needles to optimize the treatment effect.
[0176] The treatment element 552 of the device 550 further
comprises a pin-shaped structure comprising a thermocouple 555
within an insulating bushing extending through a middle portion of
the front surface of the treatment element 552. In some
embodiments, different heat sensors (e.g., thermistors) may be
used. As described above, in some embodiments, the thermocouple 555
is configured to measure a temperature of the surface or subsurface
of tissue to be treated or tissue near the tissue to be treated. A
pin-shape having a sharp point may allow the structure to penetrate
the tissue to obtain temperature readings from below the surface.
The thermocouple can also be configured to measure a temperature of
the treatment element 552 itself. The temperature measurements
taken by the thermocouple can be routed as feedback signals to a
control unit (e.g., the control system 42 described with respect to
FIG. 3) and the control unit can use the temperature measurements
to adjust the intensity of energy being delivered through the
electrode. In some embodiments, thermocouples or other sensing
devices may be used to measure multiple tissue and device
parameters. For example, multiple thermocouples or thermistors may
be used to measure a temperature at different locations along the
treatment element. In some embodiments, one of the sensors may be
configured to penetrate deeper into the tissue to take a
measurement of a more interior section of tissue. For example, a
device may have multiple sensors configured to measure a
temperature at the mucosa, the cartilage, and/or the treatment
element itself. As described above, in some embodiments, the
sensors described herein are configured to take a measurement of a
different parameter. For example, tissue impedance can be measured.
These measurements can be used to adjust the intensity and/or
duration of energy being delivered through the treatment element.
This type of feedback may be useful from both an efficacy and a
safety perspective.
[0177] In some embodiments, the treatment element has a width or
diameter of about 0.25 inches to about 0.45 inches. In some
embodiments, the treatment element is about 0.4 inches to about 0.5
inches long. The treatment element can, in some embodiments,
comprise a ceramic material (e.g., zirconium, alumina, silicon
glass). Such ceramics may advantageously possess high dielectric
strength and high temperature resistance. In some embodiments, the
treatment element comprises polyimides or polyamides which may
advantageously possess good dielectric strength and elasticity and
be easy to manufacture. In some embodiments, the treatment element
comprises thermoplastic polymers. Thermoplastic polymers may
advantageously provide good dielectric strength and high
elasticity. In some embodiments, the treatment element comprises
thermoset polymers, which may advantageously provide good
dielectric strength and good elasticity. In some embodiments, the
treatment element comprises glass or ceramic infused polymers. Such
polymers may advantageously provide good strength, good elasticity,
and good dielectric strength.
[0178] In some embodiments, the electrodes have a width or diameter
of about 0.15 inches to about 0.25 inches. In some embodiments, the
electrode is about 0.2 inches to about 0.5 inches long. In some
embodiments, the treatment element comprises steel (e.g.,
stainless, carbon, alloy). Steel may advantageously provide high
strength while being low in cost and minimally reactive. In some
embodiments, the electrodes or energy delivery elements described
herein comprise materials such as platinum, gold, or silver. Such
materials may advantageously provide high conductivity while being
minimally reactive. In some embodiments, the electrodes or energy
delivery elements described herein comprise anodized aluminum.
Anodized aluminum may advantageously be highly stiff and low in
cost. In some embodiments, the electrodes or energy delivery
elements described herein comprise titanium which may
advantageously possess a high strength to weight ratio and be
highly biocompatible. In some embodiments, the electrodes or energy
delivery elements described herein comprise nickel titanium alloys.
These alloys may advantageously provide high elasticity and be
biocompatible. Other similar materials are also possible.
[0179] Energy applied to the tissue to be treated using any
combination of the embodiments described in this application may be
controlled by a variety of methods. In some embodiments,
temperature or a combination of temperature and time may be used to
control the amount of energy applied to the tissue. Tissue is
particularly sensitive to temperature; so providing just enough
energy to reach the target tissue may provide a specific tissue
effect while minimizing damage resulting from energy causing
excessive temperature readings. For example, a maximum temperature
may be used to control the energy. In some embodiments, time at a
specified maximum temperature may be used to control the energy. In
some embodiments, thermocouples, such as those described above, are
provided to monitor the temperature at the electrode and provide
feedback to a control unit (e.g., control system 42 described with
respect to FIG. 3). In some embodiments, tissue impedance may be
used to control the energy. Impedance of tissue changes as it is
affected by energy delivery. By determining the impedance reached
when a tissue effect has been achieved, a maximum tissue impedance
can be used to control energy applied.
[0180] In the embodiments described herein, energy may be produced
and controlled via a generator that is either integrated into the
electrode handpiece or as part of a separate assembly that delivers
energy or control signals to the handpiece via a cable or other
connection. In some embodiments, the generator is an RF energy
source configured to communicate RF energy to the treatment
element. For example, the generator may comprise a 460 KHz sinusoid
wave generator. In some embodiments, the generator is configured to
run between about 1 and 100 watts. In some embodiments, the
generator is configured to run between about 5 and about 75 watts.
In some embodiments, the generator is configured to run between
about 10 and 50 watts.
[0181] In some embodiments, the energy delivery element comprises a
monopolar electrode (e.g., electrode 535 of FIG. 22G). Monopolar
electrodes are used in conjunction with a grounding pad. The
grounding pad may be a rectangular, flat, metal pad. Other shapes
are also possible. The grounding pad may comprise wires configured
to electrically connect the grounding pad to an energy source
(e.g., an RF energy source).
[0182] In some embodiments, the energy delivery element such as the
electrodes described above can be flat. Other shapes are also
possible. For example, the energy delivery element can be curved or
comprise a complex shape. For example, a curved shape may be used
to place pressure or deform the tissue to be treated. The energy
delivery element may comprise needles or microneedles. The needles
or microneedles may be partially or fully insulated. Such needles
or microneedles may be configured to deliver energy or heat to
specific tissues while avoiding tissues that should not receive
energy delivery.
[0183] In some embodiments, the electrodes or energy delivery
elements described herein comprise steel (e.g., stainless, carbon,
alloy). Steel may advantageously provide high strength while being
low in cost and minimally reactive. In some embodiments, the
electrodes or energy delivery elements described herein comprise
materials such as platinum, gold, or silver. Such materials may
advantageously provide high conductivity while being minimally
reactive. In some embodiments, the electrodes or energy delivery
elements described herein comprise anodized aluminum. Anodized
aluminum may advantageously be highly stiff and low in cost. In
some embodiments, the electrodes or energy delivery elements
described herein comprise titanium which may advantageously possess
a high strength to weight ratio and be highly biocompatible. In
some embodiments, the electrodes or energy delivery elements
described herein comprise nickel titanium alloys. These alloys may
advantageously provide high elasticity and be biocompatible. Other
similar materials are also possible.
[0184] In some embodiments, the treatment elements (e.g.,
non-electrode portion of treatment element) of the devices
described herein, including but not limited to FIGS. 8A-J, 9A-B,
10A-B, 11A-B, 12A-B, 13A-E, 14A-B, 15A-C, 16, 17A-B, 18, 19A-B,
20A-B, 21A-B, 22A-G, 23A-G, 25A-B, 26, 27, 28A-E, and 29, comprise
an insulating material such as a ceramic material (e.g., zirconium,
alumina, silicon glass). In some embodiments, the treatment
elements comprise an insulating material interposed between
multiple electrodes or electrode section. These insulating sections
may provide an inert portion of the treatment element that does not
delivery energy to the tissue. Such ceramics may advantageously
possess high dielectric strength and high temperature resistance.
In some embodiments, the insulators described herein comprise
polyimides or polyamides which may advantageously possess good
dielectric strength and elasticity and be easy to manufacture. In
some embodiments, the insulators described herein comprise
thermoplastic polymers. Thermoplastic polymers may advantageously
provide good dielectric strength and high elasticity. In some
embodiments, the insulators described herein comprise thermoset
polymers, which may advantageously provide good dielectric strength
and good elasticity. In some embodiments, the insulators described
herein comprise glass or ceramic infused polymers. Such polymers
may advantageously provide good strength, good elasticity, and good
dielectric strength.
[0185] In some embodiments, the handle and/or shaft of the devices
comprise the same materials as those described with respect to the
insulators. In some embodiments, the handle and/or shaft of the
device comprises a metal, such as stainless steel. In other
embodiments, the handle and/or shaft of the device comprises a
polymer, such as polycarbonate. Other metals and polymers are also
contemplated.
[0186] In some embodiments, the device may be used in conjunction
with a positioning element that can be used to aid in positioning
of the device. The positioning element may be integrated into the
device itself or can be separate. The positioning element may be
used to determine the optimal placement of the device to achieve
maximal increase in efficacy. In some embodiments, a positioning
element is configured to be inserted and manipulated within the
nose until the patient reports a desired improvement in breathing.
The treatment device may then be used to treat while the
positioning element is holding the nose in the desired
configuration. In some embodiments, molds described herein may be
used for the same purpose.
[0187] In some embodiments, a positioning element comprises a shaft
comprising measurement marks indicating depth. For example, a
physician may insert this element into the nose to manipulate the
tissue to find the depth of treatment at which the patient reports
the best breathing experience. The positioning element may comprise
marks around the base of the shaft indicating which point of
rotation of the device within the nostril provides the best
breathing experience. The positioning element may also comprise
marks indicating angle of insertion. The physician may then use the
measurement marks to guide insertion of the treatment element to
the same spot.
[0188] It will be appreciated that any combination of electrode
configurations, molds, handles, connection between handles, and the
like may be used to treat the nasal septum.
Examples of Treatment Devices Including Cooling Systems
[0189] Embodiments of devices configured to heat specific tissue
while maintaining lower temperatures in other adjacent tissue are
provided. These devices may be incorporated into any of the
treatment apparatuses and methods described herein. The nasal
septum is an example of a tissue complex that includes adjacent
tissues that may benefit from being maintained at different
temperatures. Other examples include the skin, which comprises the
epidermis, dermis, and subcutaneous fat, the tonsils, which
comprise mucosa, glandular tissue, and vessels. Treatment of other
tissue complexes is also possible. For example, in some
embodiments, the nasal septum may be heated while maintaining a
lower temperature in the mucosal lining of the nose and/or skin. In
other embodiments, the cartilage may be heated, while maintaining
lower temperatures in the mucosa. Limiting unwanted heating of
non-target tissues may allow trauma and pain to be reduced, may
reduce scarring, may preserve tissue function, and may also
decrease healing time. Combinations of heat transfer and/or heat
isolation may allow directed treatment of specific tissue such as
cartilage, while excluding another tissue, such as mucosa, without
surgical dissection.
[0190] Generally, when using a device 570 with an electrode 572
(e.g., monopolar RF electrode) to heat nasal cartilage, the
electrode 572 must be in contact with the mucosa. FIG. 24A shows a
cross-section of tissue at the nasal septum. The cross-section
shows that the nasal cartilage 704 sits in between layers of mucosa
702. When the electrode 572 is activated, both the mucosa and the
cartilage are heated by the current flowing from the electrode to
the return (e.g., ground pad), as shown in FIG. 24B. The tissue
closest to the electrode 572 receives the highest current density,
and thus, the highest heat. A surface cooling mechanism may allow
the temperature of the electrode surface to be reduced. Such a
cooling mechanism may maintain a lower temperature at the mucosa
even though current flow will continue to heat the cartilage.
[0191] FIG. 25A depicts a device 580 configured to treat the nasal
septum cartilage using an electrode while maintaining a reduced
temperature at the mucosa. The device comprises a treatment element
582 comprising an electrode 584 at the distal tip of the device
580. The treatment element 582 is attached to a distal end of a
shaft 586, which is attached to the distal end of a handle 588.
Input and output coolant lines 590, 592 are attached to a pump and
reservoir 594 and extend into the handle 588, through the distal
end of the treatment element 582 to the electrode 582 and return
back through the shaft 586 and handle 588 to the pump and reservoir
594. The coolant may be remotely cooled in the reservoir and may
comprise a fluid or gas. The coolant flowing through the electrode
582 may allow the treatment element 582 to be maintained at a
reduced temperature while still allowing current flow to heat the
cartilage. Examples of coolant include air, saline, water,
refrigerants, and the like. Water may advantageously provide
moderate heat capacity and be non-reactive. Refrigerants may
advantageously be able to transfer significant amounts of heat
through phase change. The coolant may flow through internal or
external cavities of the electrode or wand tip. For example, FIG.
25B depicts an embodiment of a device 600 comprising a treatment
element 602 with an electrode 604 at the distal tip of the device
600. The treatment element 602 is attached to the distal end of a
shaft 606 which is attached to the distal end of a handle 608. The
handle may be attached to a cable comprises a lumen or channel 611
through which gas or fluid may flow. The lumen 611 may diverge,
near the treatment element 602, into separate external channels
flowing over the electrode 604. The lumen 611 and channels 610 or
cavities may be attached to a fan or fluid pump 612. In some
embodiments, the fan or fluid pump may remotely cool the gas or
fluid.
[0192] FIG. 26 depicts another embodiment of a device 620
configured to treat the nasal septum using an electrode 624 while
maintaining a reduced temperature at the mucosa and/or skin. The
device comprises a treatment element 622 comprising an electrode
624 at its distal end. The treatment element 622 is connected to
the distal end of a shaft 626 which is connected to the distal end
of a handle 628. The device 620 comprises a heat pipe 630 attached
to the electrode 624 or treatment element 622. The heat pipe 630 is
configured to transfer heat to a remote heat sink 632. As shown in
FIG. 26, the heat sink 632 may be placed in the handle of the
device. In some embodiments, the heat sink may be placed remotely.
The heat pipe 630 may comprise a sealed tube (e.g., a copper tube)
filled with a material that evaporates at a given temperature. When
one end of the heat pipe 630 is heated, the fluid may evaporate and
flow to the opposite end where it may condense and subsequently
transfer heat to the heat sink 632. Using a material such as copper
for the heat pipe 630 and/or heat sink 632 may advantageously
provide high heat and electrical conductivity.
[0193] FIG. 27 depicts another embodiment of a device 640
configured to treat the nasal septum using a bipolar electrode pair
while maintaining a reduced temperature at the mucosa or the skin.
The device 640 comprises a first treatment element 642 comprising a
first electrode 644 of a bipolar electrode pair at the distal end
of a shaft 646. The treatment element 642 comprises a thermocouple
pin 650 like that described with respect to FIG. 22G. The shaft 646
is connected to the distal end of a handle 648. The handle 648 is
connected to another handle 652 comprising a shaft 654 with a
treatment element 656 at its distal tip. The treatment element 656
comprises a second electrode 657 of the bipolar electrode pair. The
first and second treatment elements 642, 656 can be placed on
either side of nasal tissue. For example, the first treatment
element 642 may be in contact with the mucosa and the second
treatment element 656 may be in contact with the skin. Similar to
the device depicted in FIG. 26, the device of FIG. 27 comprises a
heat pipe within both shafts 654, 646. Thus heat from the tissue is
transferred from the treatment elements 642, 656 and is transported
down the shafts 654, 646 into an integrated or a remote heat sink
(not shown). This heat transfer may keep the skin and/or the mucosa
relatively cool while still delivering sufficient treatment energy
to the cartilage. The connection 658 and spring 647 between the two
handles 648, 652 is configured to bias the two shafts 646, 654 and
treatment elements 642, 656 towards a collapsed state. Squeezing
the handles 648, 652 may separate the two shafts 646, 654 and
treatment elements 642, 656. Thus, the handles 648, 652 can be
squeezed to properly position the device 640 at the nasal tissue to
be treated. Releasing the handles 648, 652 can cause the treatment
element 642 and the cooling element 656 to contact the tissue. In
some embodiments, the device 640 may only comprise one heat pipe.
In some embodiments, the device 640 may comprise a treatment
element with a monopolar electrode on one shaft and a molding
element on the other shaft. Multiple configurations are
contemplated. For example, the device may comprise one heat pipe
and a bipolar electrode pair. For another example, the device may
comprise one heat pipe and a monopolar electrode. For another
example, the device may comprise two heat pipes and a monopolar
electrode. Other device configurations are also possible.
[0194] The embodiments described with respect to FIGS. 25A-27
employ specific differential cooling mechanisms to maintain
different and particular temperatures in adjacent tissues. FIGS.
28A-28E depicts various examples of more general mechanisms
configured to maintain different temperatures in adjacent tissues.
FIGS. 28A-28E depict examples of differential cooling mechanisms as
applied to a cross-section of tissue at the nasal septum, like that
shown in FIG. 24A. The nasal septum may include a middle cartilage
layer 704 with mucosal tissue 702 on either side.
[0195] As shown in FIG. 28A, in some embodiments, the differential
cooling mechanism comprises two elements: a first element 708 and a
second element 710. The two elements are on either side of the
thickness of the nasal tissue. In one embodiment, the mechanism is
configured to maintain normal temperatures in the cartilage 704
while cooling mucosal tissue 702 on a first side and mucosal tissue
702 on a second side. In such an embodiment, the first and second
elements 708, 710 comprise a cooling apparatus such as those
described above (e.g., heatsink, coolant lines, etc.). In some
embodiments, the mucosal tissue 702 on the first and second sides
is heated while normal temperatures are maintained in the
cartilaginous middle layer 704. The cartilage 704 may be somewhat
warmed, in such embodiments, but may be cooler than mucosal tissue
702 on the first and second sides. In such embodiments, the first
and second elements 708, 710 comprise a heating apparatus, such as
radio frequency electrodes or resistive heating elements. In some
embodiments, mucosal tissue 702 on the first side is heated, the
mucosal tissue 702 on second side is cooled, and normal
temperatures are maintained in the cartilage 704. In such
embodiments, the first element 708 comprises a heating apparatus
and the second element 710 comprises a cooling apparatus. For
example, the device 580, described with respect to FIG. 27, may use
such a mechanism. In some embodiments, the second side is heated,
the first side is cooled, and normal temperatures are maintained in
the cartilage 704. In such embodiments, the first element 708
comprises a cooling apparatus and the second element 710 comprises
a heating apparatus. Again, the device 580, described with respect
to FIG. 27, is an example of a device that may use such a
mechanism.
[0196] FIG. 28B shows an example of one of the embodiments
described with respect to FIG. 28A. The first element 730 is on
mucosal tissue 702 on a first side of the nasal septum. The second
element 732 is an energy delivery element and is positioned on
mucosal tissue 702 on a second side of the nasal septum. The first
element 730 comprises a cooling apparatus and the second element
732 comprises an energy delivery element (e.g., an RF electrode).
The a first side is cooled while a second side and cartilaginous
areas 704 are heated. In other embodiments, the first element 730
can be positioned on mucosal tissue 702 on the second side and the
second element 732 can be positioned on mucosal tissue 702 on the
first side. In such embodiments, the mucosal tissue 702 on the
second side is cooled while mucosal tissue 702 on the first side
and the cartilage 704 are heated.
[0197] As shown in FIG. 28C, in some embodiments, the differential
cooling mechanism comprises a first element 720 and a second
element 722. Both elements 720, 722 are on mucosal tissue 702 on
the first side of the nasal septum. In some embodiments, the
mucosal tissue 702 on the first side is cooled while higher
temperatures are maintained in the middle cartilaginous layer 704.
In such embodiments, the first element 720 comprises a cooling
apparatus, and the second element 722 comprises an energy delivery
apparatus (e.g., a monopolar radiofrequency electrode). In some
embodiments, the first element 720 is sufficiently efficient to
maintain cool temperatures at mucosal tissue 702 on the first side
despite the energy provided by the second element 722. In other
embodiments, the first and second elements 720, 722 are both
positioned on mucosal tissue 702 on the second side of the nasal
septum. In such embodiments, mucosal tissue 702 on the second side
is cooled while higher temperatures are maintained in the middle
cartilaginous layer.
[0198] As shown in FIG. 28D, in some embodiments, the differential
cooling mechanism comprises a first surface element 740 and a
second surface element 742 on either side of the nasal septum. A
third subsurface element 744 is engaged through the mucosal tissue
702 on the first side and into the cartilage area 704. In some
embodiments, the mucosal tissue 702 on the first side and the
second side are cooled while the middle cartilaginous layer 704 is
heated. In such embodiments, the first and second elements 740, 742
comprise cooling apparatus while the third element 744 comprises a
heating element (e.g., RF monopolar electrode, RF bipolar needles,
etc.). In other embodiments, the third subsurface element 744 may
be engaged through the mucosal tissue 702 on the second side and
into the cartilage area 704.
[0199] As shown in FIG. 28E, in some embodiments, the differential
cooling mechanism comprises a first surface element 750 and a
second surface element 752 on either side of the nasal septum. The
differential cooling mechanism further comprises a third surface
element 754 and a fourth surface element 756 on either side of the
nasal septum. In some embodiments, the cartilage layer 704 is
heated while the mucosal tissue 702 on the first and second sides
are cooled. In such embodiments, the first and second elements 750,
752 comprise cooling apparatus and the third and fourth elements
754, 756 comprise energy delivery apparatuses (e.g., bipolar plate
electrodes). In some embodiments, the cartilage 704 and mucosal
tissue 702 on the first side are heated while the mucosal tissue on
the second side is cooled. In such embodiments, the first element
750 comprises a heating apparatus; the second element 752 comprises
a cooling apparatus; and the third and fourth elements 754, 756
comprise energy delivery apparatuses. It will be appreciated that
different differential temperature effects can be achieved by
reconfiguring and adding or subtracting to the described
configuration of elements.
[0200] Cooling occurring before, during, or after treatment may
effect reduced temperature of the skin and/or mucosa. In some
embodiments, attaching passive fins or other structures to the
electrode or wand tip may allow for heat dissipation to the
surrounding air. In some embodiments, the device may be configured
to spray a cool material such as liquid nitrogen before, during, or
after treatment. Using a material such as copper for the passive
fins or other structure may advantageously provide high heat and
electrical conductivity. In some embodiments, using metals with a
high heat capacity in the device (e.g., in the energy delivery
element, the reshaping element, or both) may advantageously provide
the ability to resist temperature change during energy delivery. In
some embodiments, pre-cooling the electrode (e.g., by
refrigeration, submersion, spraying with a cool substance like
liquid nitrogen, etc.) may maintain a reduced temperature at the
mucosa. Any combination of the cooling methods described herein may
be used in conjunction with any of the energy delivery methods
described herein (e.g., bipolar RF electrodes, arrays needles,
plates, etc.). For example, FIG. 29 depicts an embodiment of a
device 800 comprising a treatment element 802 comprising electrode
needles 804 at its distal tip. The device 800 may be used in
conjunction with a separate cooling device 810 which may comprise
channels 811 or cavities to circulate air or fluid. The independent
cooling device 810 may, in other embodiments, employ a different
cooling mechanism.
[0201] In embodiments using laser energy to heat cartilage, it is
possible to use a combination of two or more lasers whose beams
converge at a location within the target tissue. This convergence
may cause more heat at that junction as compared to locations where
only a single beam is acting. The junction may be controlled
manually or via computer control. Specific treatment may be
provided.
[0202] In some embodiments, insulating material may be used to
protect non-target tissue during energy delivery. For example, an
electrode needle may be preferentially insulated on a portion of
the needle that is in contact with non-target tissue. For another
example, flat electrode blades may be insulated on a portion of the
blade that is in contact with non-target tissue. Other
configurations for heat isolation are also possible.
[0203] Any of the cooling mechanisms or combinations of the cooling
mechanisms described herein may be used in conjunction with any of
the devices or combinations of devices described herein, or the
like.
Examples of Methods of Treatment
[0204] Embodiments of methods for treating nasal airways are now
described. Such methods may treat nasal airways by decreasing the
airflow resistance or the perceived airflow resistance at the site
of a nasal septum. Such treatments may also address related
conditions, such as snoring. The methods may include using a device
similar to those devices described above--including but not limited
to FIGS. 8A, 9B, 18, 22A-G, and 23A-G--to provide tissue
reshaping/molding and to impart energy to tissue near the nasal
septum.
[0205] In one embodiment, a method of decreasing airflow resistance
in a nose comprises the steps of inserting an energy-delivery or
cryo-therapy device into a nasal passageway, and applying energy or
cryo-therapy to a targeted region or tissue of the nasal
passageway. For example, in some embodiments, the method may
include delivering energy or cryo-therapy to a section of nasal
septum cartilage. Energy and cryo-therapy can be applied to
cartilage in the area of the upper lateral cartilage, or in the
area of intersection of the upper and lower lateral cartilage. In
alternative embodiments, the method may deliver energy to the
epithelium, or underlying soft tissue adjacent to the nasal septum,
the upper lateral cartilage and/or the intersection of the ULC and
the LLC.
[0206] In another embodiment, a method comprises heating a section
of nasal septum cartilage to be reshaped, applying a mechanical
reshaping force, and then removing the heat. In some embodiments,
the step of applying a mechanical reshaping force may occur before,
during or after the step of applying heat.
[0207] In some embodiments, the method may further include the step
of inserting a reshaping device into the nasal passageway after
applying an energy or cryo-therapy treatment. In such embodiments,
a reshaping device such as an external adhesive nasal strip (such
as those described for example in U.S. Pat. No. 5,533,499 to
Johnson or U.S. Pat. No. 7,114,495 to Lockwood, the entirety of
each of which is hereby incorporated by reference) may be applied
to the exterior of the nose after the treatment in order to allow
for long-term reshaping of nasal septum structures as the treated
tissues heal over time. In alternative embodiments, a temporary
internal reshaping device (such as those taught in U.S. Pat. No.
7,055,523 to Brown or U.S. Pat. No. 6,978,781 to Jordan, the
entirety of each of which is hereby incorporated by reference) may
be placed in the nasal passageway after treatment in order to allow
for long-term reshaping of nasal septum structures as the treated
tissues heal over time. In some embodiments, the dilating nasal
strips can be worn externally until healing occurs.
[0208] In alternative embodiments, internal and/or external
reshaping devices may be used to reshape a nasal septum section
prior to the step of applying energy or cryo-therapy treatments to
targeted sections of the epithelial, soft tissue, mucosa, submucosa
and/or cartilage of the nose. In some embodiments, the energy or
cryo-therapy treatment may be configured to change the properties
of treated tissues such that the tissues will retain the modified
shape within a very short time of the treatment. In alternative
embodiments, the treatment may be configured to reshape nasal
septum structures over time as the tissue heals.
[0209] In some embodiments, a portion of the nose, the nasal septum
and/or the soft tissue and cartilage of the nasal valve may be
reshaped using a reshaping device and then fixed into place. In
some embodiments, such fixation may be achieved by injecting a
substance such as a glue, adhesive, bulking agent or a curable
polymer into a region of the nasal tissue adjacent the target area.
Alternatively, such a fixation substance may be applied to an
external or internal surface of the nose.
[0210] In some embodiments, an injectable polymer may be injected
into a region of the nose, either below the skin on the exterior of
the nose, or under the epithelium of the interior of the nose. In
some embodiments, an injectable polymer may include a two-part
mixture configured to polymerize and solidify through a purely
chemical process. One example of a suitable injectable two-part
polymer material is described in U.S. Patent Application
Publication 2010/0144996, the entirety of which is hereby
incorporated by reference. In other embodiments, an injectable
polymer may require application of energy in order to cure,
polymerize or solidify. A reshaping device may be used to modify
the shape of the nasal septum before or after or during injection
of a polymer. In embodiments employing an energy-curable polymer, a
reshaping device may include energy-delivery elements configured to
deliver energy suitable for curing the polymer to a desired degree
of rigidity.
[0211] In another embodiment, the soft tissue of the upper lip
under the nares may be debulked or reshaped to reduce airflow
resistance. In some embodiments, such reshaping of the upper lip
soft tissue may be achieved by applying energy and/or cryotherapy
from an external and/or internal treatment element. In some
embodiments, the tissue of the upper lip under the nares may be
compressed by an internal or external device prior to or during
application of the energy or cryo-therapy. For example, devices
such as those shown in FIGS. 5A and 5B may be adapted for this
purpose by providing tissue-engaging clamp tips shaped for the
purpose.
[0212] In another embodiment, the muscles of the nose and/or face
are stimulated to affect (e.g., dilate) the nasal septum area prior
to or during application of other treatments such as energy/cryo
application or fixation treatments. In such embodiments, the
muscles to be treated may include the nasal dilator muscles
(nasalis) the levator labii, or other facial muscles affecting the
internal and/or external nasal valves. In some embodiments, the
targeted muscles may be stimulated by applying an electric current
to contract the muscles, mentally by the patient, or manually by
the clinician.
[0213] In some embodiments, the muscles of the nose and/or face may
also be selectively deactivated through chemical, ablative,
stimulatory, or mechanical means. For example, muscles may be
deactivated by temporarily or permanently paralyzing or otherwise
preventing the normal contraction of the muscle tissue. Chemical
compounds for deactivating muscle tissues may include botulinum
toxin (aka "Botox"), or others. Ablative mechanisms for
deactivating muscle tissue may include RF ablation, laser ablation
or others. Mechanical means of deactivating muscle tissues may
include one or more surgical incisions to sever targeted muscle
tissue.
[0214] In another embodiment, the tissue of the nasal septum may be
reshaped by applying energy to the internal and external walls of
the nose using a clamp like device as illustrated for example in
FIGS. 5A and 5B. One arm of the clamp may provide inward pressure
to the external, skin side tissue covering nasal tissue and the
other side of the clamp may provide outward pressure to the mucosal
tissue on nasal tissue (e.g., the lateral wall of the nasal airway
above the ULC and LLC or both).
[0215] In some embodiments, energy may be applied to the skin of
the nose to effect a shrinkage of the skin, epidermis, dermis,
subdermal, subcutaneous, tendon, ligament, muscle, cartilage and/or
cartilage tissue. The tissue shrinkage is intended to result in a
change of forces acting on the tissues of the nasal septum.
[0216] In another embodiment, the nasal septum tissue may be
damaged or stimulated by energy application, incisions, injections,
compression, or other mechanical or chemical actions. Following
such damage, a device may be used on the tissue to mold or shape
the tissue of the septum during healing. In some embodiments, such
a reshaping device may be temporarily placed or implanted inside or
outside the patient's nose to hold a desired shape while the
patient's healing process progresses.
[0217] In another embodiment, the aesthetic appearance of the nose
may be adjusted by varying the device design and/or treatment
procedure. The predicted post-procedure appearance of the nose may
be shown to the patient through manipulating the nasal tissue to
give a post procedure appearance approximation. The patient may
then decide if the predicted post procedure appearance of the face
and nose is acceptable or if the physician needs to change
parameters of the device or procedure to produce an appearance more
acceptable to the patient.
[0218] In another embodiment, reduction of the negative pressure in
the nasal airway can be effected to reduce collapse of the
structures of the nasal airway on inspiration without changing a
shape of the nasal septum. For example, this may be accomplished by
creating an air passage that allows flow of air directly into the
site of negative pressure. One example of this is creating a hole
through the lateral wall of the nose allowing airflow from the
exterior of the nose through the nasal wall and into the nasal
airway.
[0219] In another embodiment, energy, mechanical or chemical
therapy may be applied to the tissue of the nasal airway with the
express purpose of changing the properties of the extracellular
matrix components to achieve a desired effect without damaging the
chondrocytes or other cells of the nasal airway tissue.
[0220] In some embodiments, devices (e.g., devices like those
described with respect to FIGS. 9A-21B) may be used to provide
tissue reshaping/molding and to impart energy to the nasal septum.
The electrode may be placed in contact with the target nasal septum
tissue. The electrodes and molds may be moved to shape the tissue
as necessary to achieve improvement in nasal airway. The electrodes
may be activated while the tissue is deformed in the new shape to
treat the tissue. The electrode may then be deactivated and the
device may be removed from the nasal septum area.
[0221] FIGS. 30A-D show an embodiment of a method for modifying a
nasal septum, viewed from the nares. FIG. 30A illustrates a view of
a nose having a deviated nasal septum 2. FIG. 30B illustrates a
substance delivery device 806 (shown as a syringe with needle, but
alternatively a swab or any other device for applying a substance
to the tissue) applying a solution 808 to tissue near the cartilage
of the nasal septum 2. FIG. 30C illustrates an energy delivery
device 800 with a treatment element applying energy to the nasal
septum. FIG. 30D illustrates a view of the nose after treatment,
having a corrected nasal septum 2.
[0222] The method may include identifying a patient who desires to
improve the airflow through their nasal passageways and/or who may
benefit from a modification to the nasal septum (e.g., the patient
has a deviated septum as shown in FIG. 30A). The patient may be
positioned either in an upright position (e.g., seated or standing)
or lying down. Local anesthesia may be applied to an area near or
surrounding the tissue to be treated. General anesthesia may also
be used.
[0223] The physician (or other medical professional administering
the treatment) may apply a chemical enzyme or other solution at the
site of the deviation to be corrected (see, e.g., FIG. 30B). In one
embodiment, for example, the physician injects the solution through
mucosal tissue to the space between the nasal mucosa and the nasal
septal cartilage. The solution may be contained in the general area
of the septal deviation, using a shield, and may be left in the
patient's septum for a designated amount of time, to allow the
solution to effectively condition the septal cartilage.
[0224] In some embodiments, the solution is between about 0.5 ml to
about 2.5 ml of collagenase at a concentration ranging from about 1
mg/ml to about 10 mg/ml. In an example, a solution can include
collagenase at a concentration of approximately 2 mg/ml. In some
embodiments, the solution is between about 0.5 ml to about 2.5 ml
of trypsin at a concentration of about 10 .mu.g/ml to about 100
.mu.g/ml. In an example, a solution can include trypsin at a
concentration of approximately 50 .mu.g/ml. The designated amount
of time may be in the range of about 15 minutes to about 90
minutes, in various embodiments. The designated amount of time can
vary based in part on the solution being used. In an example, the
designated amount of time can be approximately 40 minutes where the
solution includes trypsin at a concentration of approximately 50
.mu.g/ml. In an example, a designated amount of time can be
approximately 20 minutes for a solution that includes collagenase
at a concentration of approximately 2 mg/ml. The application of the
solution may result in a narrow band of degraded cartilage ranging
from about 100 .mu.m to about 1 mm from the cartilage surface in
the area of application. Prior to the application of the solution,
the solution may be prepared at a particular temperature (e.g.,
between about 20.degree. C. and about 80.degree. C., or at about
20.degree. C., 37.degree. C., 60.degree. C., or 80.degree. C.).
[0225] At the conclusion of the conditioning period, a device
(e.g., a monopolar, bipolar, single electrode, or multi-electrode
RF energy device) may be introduced to the area to be corrected,
and energy (e.g., RF energy) may be applied to the site (see, e.g.,
FIG. 30C). The temperature and duration of the energy application
may be selected to denature and/or deactivate the solution and/or
reshape the septal cartilage to correct the septal deviation (see,
e.g., FIG. 30D). In addition to energy, mechanical force can also
be applied to aid in reshaping the cartilage. Reshaping the
cartilage can include increasing a nasal cross-sectional area with
or without changing a nasal valve angle. Reshaping the cartilage
can include changing a nasal valve angle. Reshaping the cartilage
can include other modifications. The cartilage can completely,
substantially, or partially maintain its shape (e.g., a corrected
deviation shape) after the device is removed and the affected
tissue heals.
[0226] Optionally, a positioning element, like that described
herein, may be used to measure a desired depth or angle of
treatment. As described above, the positioning element may be be
inserted to the desired depth of treatment and rotated to a desired
angle of treatment. Marks along the positioning element can
indicate the desired depth. Marks along the base of the shaft of
the positioning element can indicate the desired angle. The
physician or other medical professional administering the treatment
can then insert the treatment device to the desired location. The
physician may also assess any other characteristics relevant to the
treatment of the patient's nose that may influence the manner of
treatment. In some embodiments, a reshaping element may be used to
manipulate the nasal tissue into a configuration allowing improved
airflow; and treatment may be performed while such a reshaping
element is maintaining the desired configuration of the nasal
tissue.
[0227] If the treatment device includes a monopolar electrode or
electrode needles, a ground pad may be attached to the patient. The
ground pad may be attached at the patient's torso, for example the
shoulder or abdomen. Other locations are also possible, such as the
patient's buttocks. Preferably, the point of attachment is a large,
fleshy area. After being attached, the ground pad may be plugged
into a power source. If the device is powered by a remote generator
(e.g., RF generator), the device may then be plugged into the
generator.
[0228] FIGS. 30E-30H depict an embodiment of a method for treating
nasal airways. FIG. 30E depicts the nose of a patient after the
solution has been applied to tissue to be treated, but prior to
insertion of a device for heating and reshaping tissue. As shown in
FIG. 30F, a device 800 is then inserted into a nostril of the
patient. The treatment element 802 of the device 800 may be
positioned within the nasal airway, adjacent to the nasal tissue
(e.g., nasal septum) to be treated. The treatment element 802 may
be positioned so that the electrode is in contact with the tissue
to be treated. The device 800 (as shown in FIG. 30G) includes
multiple needle electrodes 804, although in alternative embodiments
the electrodes 804 might not be needles. The needle electrodes 804
may be inserted so that they are penetrating or engaging tissue to
be treated.
[0229] The treatment element 802 may be used to deform the nasal
tissue into a desired shape by pressing a convex surface of the
treatment element 802 against the nasal tissue to be treated. FIG.
30G shows an internal view, from the nares, of the treatment
element 802 pushing against the nasal septum and deforming the
nasal septum. FIG. 30H depicts an external view of the treatment
element 802 deforming the nasal septum. In some embodiments, even
from the outside, the nose appears to be bulging near the area to
be treated. In some embodiments, the deformation required to treat
the nose is not visually detectable. A control input, such as
button 814 may be used to activate the electrode and deliver energy
(e.g., RF energy) to the tissue to be treated.
[0230] In some embodiments, temperature of the area around the
electrode during treating is from about 30.degree. C. to about
90.degree. C. In some embodiments, temperature of the area around
the electrode during treating is from about 40.degree. C. to about
80.degree. C. In some embodiments, temperature of the area around
the electrode during treating is from about 50.degree. C. to about
70.degree. C. In some embodiments, temperature of the area around
the electrode during treating is about 60.degree. C. In some
embodiments, for example during cryo-therapy, temperature of the
area around the electrode may be lower. In some embodiments, the
temperature is measured at the target tissue rather than the area
around the electrode during treating.
[0231] In some embodiments, treating the target tissue includes
treatment for about is to about 3 minutes. In some embodiments,
treating the target tissue includes treatment for about 10 seconds
to about 2 minutes. In some embodiments, treating the target tissue
includes treatment for about 15 seconds to about 1 minute. In some
embodiments, treating the target tissue includes treatment for
about 20 seconds to about 45 seconds. In some embodiments, treating
the target tissue includes treatment for about 30 seconds.
[0232] In some embodiments, treating the target tissue includes
delivering between about 1 and about 100 watts to the tissue. In
some embodiments, treating the target tissue includes delivering
between about 5 and about 75 watts to the tissue. In some
embodiments, treating the target tissue includes delivering between
about 10 and about 50 watts to the tissue. In some embodiments, the
wattage is selected based on an amount of wattage needed to produce
a desired temperature at a particular location. In some
embodiments, wattage is selected based on an amount of wattage used
to produce a temperature of 60.degree. C. in the cartilage.
[0233] As shown in FIGS. 30F and 30H, a thermocouple 812 may be
provided on the electrode (e.g., as described with reference to
FIGS. 22G and 27). In some embodiments, more than one thermocouple
may be provided. For example, in embodiments comprising more than
one electrode or electrode pair, each electrode or electrode pair
may include a thermocouple. The thermocouple 812 may monitor
temperature of the electrode and provide feedback to a control unit
(e.g., control system 42 described with respect to FIG. 3). The
control unit may use the data from the thermocouple 812 to regulate
temperature and auto-shutoff once treatment has been achieved or in
the case of an overly high temperature.
[0234] After treating the tissue, the device 800 may be removed
from the nostril. If a grounding pad is used, the grounding pad may
be detached from the patient.
[0235] In some embodiments, differential cooling mechanisms may be
used to treat the nasal septum using electrodes or other energy
delivery elements while maintaining a reduced temperature at the
skin and/or mucosa. For example, devices like those described with
respect to FIGS. 25A-27 or devices employing the differential
cooling mechanisms described with respect to FIGS. 28A-28E may be
used. The cooling system may be activated. The device may then be
inserted into the nose and placed in contact with the nasal septum.
The device may then be activated. Activation of the device may
cause an increase in the cartilage temperature while minimizing the
temperature increase in the skin and/or mucosa. The device may then
be deactivated and removed from the nose.
[0236] In some embodiments, devices may be used in which insulating
material is used to protect non-target tissue during energy
delivery. In an embodiment, a device includes an electrode needle
preferentially insulated on a portion of the needle. The needle may
be inserted into the cartilage so that the insulated portion is in
contact with the mucosa and/or the skin and the non-insulated
portion is in contact with the cartilage. The device may be
activated, causing an increase in the cartilage temperature while
minimizing temperature increase in the skin and/or mucosa. The
device may be deactivated and removed from the nose.
Additional Embodiments and Optional Features
[0237] Referring now to FIGS. 31A and 31B, in one embodiment, a
device 900 for treating a nasal valve may include an internal power
source and thus be cordless. In the embodiment shown, the device
900 includes a handle 902 coupled with a shaft 904, which in turn
is coupled with a treatment element 908. The handle 902 may include
a power button 910 (or "on/off switch"), a circuit board (912, FIG.
31B) and a space and connections for insertion of batteries 914 as
a power source. Treatment element 904 may include multiple needle
electrodes 906 for applying RF energy to tissue.
[0238] Any suitable features, elements, materials or the like that
have been described above may be applied to the device 900 in a
similar way. In various alternative embodiments, the device 900 may
include any number, size or type of batteries, depending on the
size of the handle 902 and power requirements of the device 900. In
some alternative embodiments, the device 900 may include an
alternative power source. For example, the batteries 914 may be
rechargeable in some embodiments. In other embodiments, it may be
possible to plug the device 900 into a power generator for
charging, and then unplug the device 900 for use. In yet other
alternative embodiments, the device 900 may include a solar power
collection member. The advantage of including an internal power
source in the device 900 is that this eliminates the need for the
device 900 to be connected, via power cord, to a large, table-top
generator, as most energy delivery surgical/medical devices
require. This allows a physician to perform a nasal valve procedure
in any location or patient orientation without having to manage
power cables and generators.
[0239] Referring now to FIGS. 32A and 32B, in some embodiments, a
system for treating a nasal valve or a nasal septum may include one
or more sensors. Such sensors may be used to sense any of a number
of relevant tissue properties, such as temperature, impedance and
the like. The sensors may be located on a treatment device in some
embodiments, or alternatively they may be separate from the
treatment device and positioned at or near the device during
treatment. In some embodiments, the sensor(s) may provide feedback
directly to the treatment device. For example if a particular
tissue temperature threshold is reached, a sensor (or sensors) may
send a signal to a power generator to shut down or decrease power
delivered to a treatment device. In alternative embodiment, the
sensor(s) may instead provide feedback to a physician or other
user, so that the physician or other user can make treatment
adjustments. For example, sensors may provide a warning signal when
a particular tissue temperature or impedance is reached, which will
help a physician know when to turn off or decrease power delivery
to a treatment device. Additionally, sensor(s) may be used to sense
one or more tissue properties in any suitable tissue or multiple
tissues, such as but not limited to mucosa, cartilage, dermis,
epidermis and other types of body soft tissue.
[0240] FIG. 32A illustrates nasal skin in cross section, including
mucosa, cartilage, dermis and epidermis. In one embodiment, a
sensor device 920 may include an epidermal sensor 922 that is
coupled to the epidermis via an adhesive 924. Any suitable sensor
922 (temperature, impedance, etc.) and any suitable adhesive 924
may be used. This embodiment of the sensor device 920 is also
illustrated on a patient's face in FIG. 32B.
[0241] In an alternative embodiment, a sensor device 930 may
include a transdermal needle sensor 932. In another alternative
embodiment, a sensor device 942 may be attached directly to a
treatment device 940. As illustrated by these various embodiments,
sensors 922, 932 and 942 may be positioned either at or near a
treatment location during a treatment. In some embodiments, for
example, a sensor 922, 932 may be placed on or in epidermis while a
treatment is being performed on mucosa and/or cartilage.
Alternatively, a sensor 942 may be placed directly on mucosa or
cartilage during a treatment of mucosa or cartilage. Additionally,
in any given embodiment, multiple sensors may be placed at multiple
different locations in and/or on tissue. As mentioned above, the
sensor devices 920, 930 and 940 may, in various embodiments,
provide any of a number of different types of feedback, such as
feedback to a user, feedback to a power generator, or both.
[0242] Referring now to FIGS. 33A and 33B, in some embodiments, a
treatment device 950 may include a treatment element 952 with wings
954 extending laterally from it. The wings 954 are configured to
help direct the treatment element 952 into a particular treatment
location/position and/or to prevent the treatment element 952 from
contacting tissue that the physician does not want to treat. For
example, FIG. 33B illustrates a top, cross-sectional view of a nose
N, showing the lateral wall LW, nasal septum S and an intersection
I between the lateral wall LW and nasal septum S. The wings 954
help prevent the treatment element 952 from being advanced far
enough to reach an undesired treatment area. Alternative
embodiments may include additional wings or other protrusions or
shapes to prevent contact with particular structures. Some
embodiments may include adjustable wings or wings that expand once
the electrodes have been placed. Any other size, shape or
configuration of one of more wings may be included, according to
various embodiments.
[0243] Referring to FIGS. 34A-34C, in various alternative
embodiments, treatment elements of nasal valve treatment devices
may have different shapes and/or sizes for addressing different
types and/or shapes of tissue. For example, as shown in FIG. 34A,
in one embodiment, a treatment element 960 of a device may have a
square or rectangular profile with a flat distal end, which may be
ideal for addressing relatively flat tissue configurations. Two
electrodes 962 (or two sets of electrodes) may be used to send an
arc of current (e.g., RF current) through tissue in the pattern
shown by the multi-headed arrow.
[0244] In another embodiment, as shown in FIG. 34B, a treatment
element 970 may have an oval profile with a curved distal end. Two
electrodes 972 or sets of electrodes send a current through tissue
in an arc. This configuration may be advantageous for addressing
tissue having a curved profile. In yet another embodiment, as shown
in FIG. 34C, a treatment element 980 may have a flatter curved
profile, for example for addressing tissue with a curved shape but
not as sharp of an angle as the tissue shown in FIG. 34B. Again,
the electrodes 982 send energy through the curved tissue in a
curved arc.
[0245] As is evident from FIGS. 34A-34C, a treatment element of a
treatment device may have any suitable configuration for
advantageously addressing any tissue type and shape. In some
embodiments, multiple different treatment devices, each having a
differently shaped treatment element, may be provided, and a user
may select a treatment device for a particular tissue type and/or
shape, based at least in part on the shape of the treatment element
of the device.
[0246] Referring to FIG. 35, in another embodiment, a treatment
device 1000 for treating a nasal septum and/or tissues near the
nasal septum may include an expandable member 1002, such as but not
limited to an expandable polymeric balloon. For example, a
non-compliant or semi-compliant balloon may be used in some
embodiments to expand tissues in and/or around the nasal valve, to
achieve one or more of the effects discussed above in relation to
the various embodiments. Although expandable balloon devices (e.g.,
balloon catheters) have been described previously for use in
expanding ostia (openings) of the sinus cavities, they have not
been described for use in changing the shape and/or physical
characteristics of the nasal valve. In various method embodiments,
the expandable member 1002 may be positioned at any of a number of
suitable locations at or near a nasal valve and then expanded to
deform tissues that make up the nasal septum. In some cases, these
tissues may be at least partially deformed permanently or at least
for a period of time after the procedure. In other cases, the
tissue may only be deformed during the procedure, but one or more
properties of the tissue may be affected by the balloon
expansion.
[0247] In various alternative embodiments, a treatment device for
nasal septum tissue and/or other nasal tissue may use a treatment
modality that does not involve delivery of energy to, or removal of
energy from, tissue. For example, in some embodiments, the
treatment device may create some kind of mechanical injury to one
or more tissues to cause a change in shape and/or one or more
properties of the tissue. The expandable balloon embodiment
described above is one example. Other examples may include, but are
not limited to, needles, micro-needles, blades or the like, any of
which may be used to cause scar tissue formation and/or tissue
contraction. Other embodiments may use sclerotherapy, involving
injecting one or more substances (acid, coagulants, etc.) into the
target tissue to induce scar tissue formation and/or other changes
in the tissue properties. In some cases, one type of tissue (for
example, mucosa or cartilage) may be transformed into a different
type of tissue altogether (for example, scar tissue). In other
examples, one or more properties of the tissue may be changed
without changing the overall type of tissue. For example, the
tissue may be caused to shrink, contract, stiffen and/or the like.
One advantage of these non-energy-based embodiments is that they do
not require a source of energy. This may make them easier to use
and possibly to manufacture and supply.
[0248] In other embodiments, thermal energy may be applied to the
nasal tissue by applying the energy from an external location on
the nose, rather than an internal location within the nasal cavity.
For example, in some embodiments, a treatment device may be
positioned on the nose and used to deliver thermal energy through
the epidermis to the nasal septum. In some embodiments, the
treatment device may also be used to cool the superficial dermis
and epidermis, for example. This delivery of energy may, in some
embodiments, act to tighten tissues of the nasal valve, thus
preventing collapse during breathing. In an alternative embodiment,
instead of using thermal energy to change the tissues, a treatment
device may use mechanical means, such as micro-needles, to create a
subdermal tissue response, such as scarring, for a similar type of
tissue tightening effect.
[0249] In yet other embodiments, some methods for treating a nasal
valve may include applying a gel, paste, liquid or similar
substance to a surface of the nose during an energy delivery
treatment of the nasal valve. Such substances may be applied to
target tissue, such as mucosa, non-target tissue, such as
epidermis, or a combination of both. The substance (or substances)
applied may serve any of a number of different purposes, such as
but not limited to modifying conductivity of tissue and providing
anesthetic effect. Conductivity enhancing substances may improve
the efficiency and/or consistency of energy delivery (such as but
not limited to RF energy). Alternatively or additionally, one or
more substances may be injected into tissue. For example, saline,
Lidocaine, other anesthetic agents, or any other suitable agents,
may be injected. Some embodiments may involve applying one
substance and injecting another substance.
[0250] In other alternative embodiments, it may be possible to
achieve desired changes in tissue properties and/or shapes by
injecting substance or applying substance only--in other words,
without also applying energy. For example, injecting a
sclerotherapy substance into tissue may, in some embodiments,
achieve a desired tissue result. In additional alternative
embodiments, a method of treating a nasal septum may include
injecting a substance into nasal tissue and then curing the
substance in order to change the substance's properties and, in
turn, at least one of the nasal tissue's properties. A treatment
device may be used to cure the substance. In some embodiments, the
treatment device may be used to deform the target tissue and cure
the substance, while the tissue is deformed, so that the tissue
retains approximately the same, deformed shape after the substance
is cured and the treatment device is removed. In another
alternative embodiment, a surface-based biodegradable agent may be
applied and cured to change the shape of the target nasal
tissue.
[0251] FIGS. 36A-36E illustrate a method and device for treating a
septum 1102 having a deviation 1104, according to some embodiments.
The method and device of FIGS. 36A-36E may include one or more
features of previously described treatment methods and devices,
including but not limited to those described in relation to FIGS.
30A-30H.
[0252] FIG. 36A illustrates septum 1102 and deviation 1104 as
though looking into a patient's left nostril. FIG. 36B illustrates
an enlarged detail view of septum 1102 and deviation 1104.
[0253] FIG. 36C illustrates an applicator 1106 applying a treatment
solution to deviation 1104. As illustrated, applicator 1106 is an
injection device used to inject the treatment solution in an area
of deviation 1104, but other application methods and applicators
may be used. Other application methods include, but are not limited
to, topical application, diffusion, current-driven application,
electrophoresis, and any other method of applying a solution and/or
enzymes to target tissue. The solution may be left to act for a
designated dwell time to allow the solution to effectively
condition the septal cartilage. The dwell time may be in the range
of about 1 minute to about 60 minutes, about 1 minute to about 40
minutes, about 1 minute to about 20 minutes, about 1 minute to
about 10 minutes, about 1 minute to about 5 minutes, or other
ranges. In some embodiments, the dwell time is less than one
minute. In some embodiments, there is approximately no dwell time
at all.
[0254] FIG. 36D illustrates a treatment device 1110 being used to
correct deviation 1104. As illustrated, treatment device 1110
includes a handle 1112, a first elongate shaft 1114 extending from
handle 1112, a first treatment element 1116 disposed at a distal
end of first shaft 1114, a second shaft 1118 extending from handle
1112, and a second treatment element 1120 disposed at a distal end
of second shaft 1118. First treatment element 1116 may include one
or more energy delivery or removal elements. First treatment
element 1116 may be configured to be placed against the tissue of
deviation 1104. Second treatment element 1120 may include one or
more energy delivery or removal elements. Second treatment element
1120 may be configured to be placed on an opposite size of septum
1102 from first treatment element 1116. For example, as
illustrated, first treatment element 1116 is placed against
deviation 1104 in the left nostril, and second treatment element
1120 may be configured to be placed against septum 1102 in the
right nostril. Second treatment element 1120 may act as a backstop,
counter-traction element, guide, or otherwise facilitate treatment
of deviation 1104 with device 1110. In some embodiments, treatment
device 1110 includes applicator 1106. For example, first treatment
element 1116 may include a needle configured as applicator 1106
adapted to apply the solution to deviation 1104. Other treatment
devices may be used.
[0255] Using treatment device 1110 to correct deviation 1104 may
include applying energy to or removing energy from septum 1102
using first treatment element 1116 and/or second treatment element
1120. In some embodiments, the application or removal of energy may
enhance, inhibit, or otherwise modify the effect of the solution on
the cartilage. In some embodiments, the application or removal of
energy may deactivate the solution so it no longer substantially
acts on the cartilage. In some embodiments applying energy to or
removing energy from septum 1102 may further treat or modify
cartilage of deviation 1104.
[0256] Using treatment device 1110 to correct deviation 1104 may
include applying mechanical energy. In some embodiments, first
treatment element 1116 and second treatment element 1120 may be
used to apply mechanical energy to septum 1102. For example, a user
may squeeze a portion of handle 1112, causing first treatment
element 1116 and second treatment element 1120 to come together and
pinch deviation 1104. In some embodiments, first treatment element
1116 moves towards second treatment element 1120, pushing deviation
1104 toward and/or against second treatment element 1120. Second
treatment element 1120 may act as a backstop. In some embodiments,
mechanical energy may be used to push deviation 1104 beyond flat,
such that once device 1110 is removed and tissue of the cartilage
heals, deviation 1104 is corrected. In some embodiments, second
treatment element 1120 may be configured as a mold. For example,
second treatment element 1120 may have a particular shape (e.g.,
concave or convex) and first treatment element 1116 may have a
complimentary shape or may otherwise be configured to shape
deviation 1104 against second treatment element 1120.
[0257] FIG. 36E illustrates septum 1102 having a corrected
deviation 1108. Compared to deviation 1104, corrected deviation
1108 may be a slightly reduced deviation, a completely removed
deviation, or otherwise corrected. A nose with corrected deviation
1108 may have improved airflow compared to a nose with deviation
1104.
[0258] FIG. 37 illustrates a channel stylus device 1200, which may
be used to treat a deviated septum, according to some embodiments.
Channel stylus device 1200 includes a handle 1202, an elongate
shaft 1204 extending from handle 1202, and an elongate treatment
element 1206. Elongate treatment element 1206 may be configured to
create channels in a deviation, thereby reducing the deviation and
improving airflow. Elongate treatment element 1206 may be further
configured to apply energy to or remove energy from tissue.
Elongate treatment element 1206 may include a plurality of pairs of
bi-polar electrodes 1208. Electrodes 1208 may be arranged in a
serial alignment along treatment element 1206 such that electrodes
1208 are in a line along treatment element 1206. For example,
electrodes 1208 may be arranged with the center of each electrode
1208 along a longitudinal axis of treatment element 1206.
[0259] FIGS. 38A-38C illustrate a method of treating a septum 1210
having a deviation 1212 using channel stylus device 1200, according
to some embodiments. FIG. 38A illustrates septum 1210 and deviation
1212 as though looking into a patient's left nostril. FIG. 38B
illustrates treatment element 1206 of channel stylus device 1200
inserted into the nostril and pressing laterally against deviation
1212, thereby reshaping deviation 1212. As illustrated in FIG. 38B,
treatment element 1206 may apply energy to or remove energy from
the tissue of deviation 1212. This may facilitate the reshaping of
deviation 1212. Before applying treatment element 1206 to deviation
1212, a treatment solution may be applied at or near deviation 1212
to facilitate treatment. By reshaping and applying energy to or
removing energy from deviation 1212, the method may create a
treated deviation that persists after treatment element 1206 is
removed and the tissue of deviation 1212 heals. Reshaping deviation
1212 may include flattening deviation 1212. Reshaping deviation
1212 may include creating air channels, troughs, or other shapes in
deviation 1212 to facilitate the flow of air. Such air channels may
be particularly useful for treating posterior-running septal
deviations. Reshaping deviation 1212 can include increasing a nasal
cross-sectional area with or without changing a nasal valve angle.
Reshaping deviation 1212 can include modifying a nasal valve angle.
FIG. 38C illustrates a treated deviation 1214 after device 1200 is
removed and the tissue of septum 1210 heals. As illustrated, air
channels 1216 through which air may flow are formed in treated
deviation 1214. Compared to deviation 1212, a patient having
treated deviation 1214 may have improved airflow through the
nostril.
[0260] FIGS. 39A-39D illustrate a method of treating a deviated
septum 1302 by treating and evacuating cartilage 1304, according to
some embodiments. FIG. 39A is a view of a nose having deviated
septum 1302. FIG. 39B illustrates an applicator 1306 applying a
solution 1308 to cartilage 1304. As illustrated, applicator 1306 is
an injector injecting solution 1308 into or near cartilage 1304.
Solution 1308 may be a solution that treats cartilage by, for
example, softening or dissolving cartilage, such as those
previously described herein. Other applicators and application
methods may also be used. After solution 1308 has been applied to
cartilage 1304, solution 1308 may be given a dwell time in which to
act on cartilage 1304. After solution 1308 is applied, treated
cartilage 1304 may be further treated, such as by a treatment
element applying energy to or removing energy from treated
cartilage 1304 or by a treatment element applying mechanical force
to treated cartilage 1304. The further treatment may be selected to
enhance, inhibit, guide, shape or otherwise modify treatment of
cartilage 1304. In some embodiments, a portion of cartilage outside
of the treatment area may be treated to denature or otherwise
deactivate solution 1308 if it reaches that portion of cartilage.
In some embodiments, the further treatment may include applying
energy or force to treated cartilage 1304 to break or further
weaken cartilage 1304 for ease of removal.
[0261] FIG. 39C illustrates an evacuator 1310 evacuating treated
cartilage 1304. After the treatment or further treatment of
cartilage 1304, cartilage 1304 may be in a condition ready for
removal. As illustrated, evacuator 1310 may be inserted into septum
1302 and used to apply suction to remove treated cartilage 1304.
Other evacuators 1310 and methods of evacuation may be used. The
evacuation of softened cartilage 1304 may be performed with or
without an incision. In some embodiments, an incision is made and
cartilage 1304 is removed through the incision. In other
embodiments, no incision is used and instead cartilage 1304 is
removed through a needle inserted into septum 1302. In other
embodiments, there is no active evacuation step. Instead, cartilage
1304 may be sufficiently treated that it does not need to be
removed; for example, treated cartilage 1304 may be naturally
resorbed by the patient's body or that cartilage 1304 is
sufficiently weak that it no longer substantially negatively
affects airflow. FIG. 39D illustrates a treated nose having a
corrected deviation of septum 1302. With deviated cartilage 1304
removed, septum 1302 is no longer deviated.
[0262] Although emphasis has been placed on structure and function
of the nasal septum in much of the foregoing description,
modifications of other cartilage or tissue may also be performed
based on the above disclosures. This may include, but need not be
limited to hyaline or other cartilage located in a subject's nose,
larynx, trachea, bronchi, airways, ribs, bones, joints, and other
locations.
[0263] Although this invention has been disclosed in the context of
certain preferred embodiments and examples, it will be understood
by those skilled in the art that the present invention extends
beyond the specifically disclosed embodiments to other alternative
embodiments and/or uses of the invention and obvious modifications
and equivalents thereof. Thus, it is intended that the scope of the
present invention herein disclosed should not be limited by the
particular disclosed embodiments described above, but should be
determined only by a fair reading of the claims that follow.
EXPERIMENTS
[0264] Experiments may be carried out to explore ranges in
concentration and volume of solutions applied to cartilage and
duration of exposure in terms of their efficacy in degrading the
cartilage surface. Additionally, the effect of temperature
variation on solution activity may be explored. The aims of the
experiments may include: comparing the effects of collagenase and
trypsin (or other enzymes or solutions) exposure on the ability to
enhance RF-induced reshaping of nasal septum cartilage and evaluate
the effects of particular RF energy exposure to reshape treated
nasal septum cartilage.
[0265] The efficacy of combined solution exposure and RF treatment
may be assessed using bovine nasal septum cartilage obtained from a
slaughterhouse. Nasal cartilage samples may be acquired within 24
hours of slaughter to ensure high cell viability and all protocols
below may be carried out under sterile conditions to enable long
term observation of cellular activity after enzyme and RF
exposure.
[0266] Concentrations, volumes, and durations of exposures for
solutions may be chosen based on previous work with articular
cartilage. See, e.g., Griffin et al, Effects of Enzymatic
Treatments on the Depth-Dependent Viscoelastic Shear Properties of
Articular Cartilage, J Orthop Res Vol. 32, Issue 12, pp. 1652-1657
(2014), incorporated herein by reference for any and all purposes.
A range of 0.5 ml to 2.5 ml of enzyme solutions may be applied to
nasal septum cartilage at concentrations ranging from 1-10 mg/ml
collagenase and/or 10-100 .mu.g/ml trypsin for times ranging from
15 to 90 minutes. In an example, a solution having a concentration
of approximately 40-60 .mu.g/ml trypsin can be applied to nasal
septum cartilage and given a dwell time of 30-60 minutes. In an
example, a solution having a concentration of approximately 50
.mu.g/ml trypsin can be applied to nasal septum cartilage and given
a dwell time of 40 minutes. In another example, a solution having a
concentration of approximately 1-3 mg/ml collagenase can be applied
to nasal septum cartilage and given a dwell time of approximately
15-25 minutes. In an example, a solution having a concentration of
approximately 2 mg/ml collagenase can be applied to nasal septum
cartilage and given a dwell time of approximately 20 minutes. Such
treatments may be expected to result in a narrow band of degraded
cartilage ranging from 100 .mu.m to 1 mm from the cartilage
surface. Additionally, prior to application of the solution to
cartilage, solutions may be prepared at 20.degree. C., 37.degree.
C., 60.degree. C., and 80.degree. C. to document the efficiency of
degradation at room temperature, body temperature, a temperature
consistent with the current operation of the RF probe, and a
temperature in excess of the current operation of the RF probe.
Immediately after solution exposure, the thickness of all samples
may be measured and subset of samples may be characterized by
live/dead staining, histology and microscopy, and mechanical
analysis by confocal elastography.
[0267] Remaining samples may be shaped using the RF probe, using
standard operating conditions (e.g., sufficient RF wattage to
produce a temperature of 60.degree. C. and application of 0.5 kg of
force to the tissue for 30 seconds). Immediately after application
of RF energy, the thickness of all samples may be measured and
subset of samples may be characterized by live/dead staining,
histology and microscopy, and mechanical analysis by confocal
elastography (see below for descriptions).
[0268] The remaining samples may be maintained in sterile culture
at 37.degree. C. in DMEM with 10% fetal bovine serum in a 5% CO2
atmosphere for times up to 1 week. After culture, these remaining
samples may be characterized by live/dead staining, histology and
microscopy, and mechanical analysis by confocal elastography (see
below for descriptions).
[0269] Experimental Procedure
[0270] The experiment may explore the combination of controlled
application of derivative solutions and RF energy to nasal
cartilage to enable reshaping of a nasal septum.
[0271] Tissue Isolation, Live/Dead Staining
[0272] Bovine nasal septa are obtained from a local slaughterhouse
within 24 hours of slaughter. Cartilage from the nasal septum is
dissected under sterile conditions and cut to produce slabs of
tissue 1 cm.times.1 cm.times.2 mm thick. Prior to use in
experiments, tissue slabs are cultured in DMEM with 10% fetal
bovine serum with 100 .mu.g/ml penicillin and 100 U/ml
streptomycin.
[0273] Prior to experiments, sample thickness is measured with
digital calipers. Digital photographs are recorded. After solution
exposure, RF exposure, and post-exposure culture, a subset of
samples are bisected and stained with a commercial live/dead kit
(such as those provided by Invitrogen, Inc.). Samples are be
exposed to 0.15 .mu.m calcein AM and 2 .mu.m ethidium homodimer-1
(EthD-1) for 60 minutes at room temperature. The stained samples
are analyzed under a microscope equipped with an epifluorescence
attachment (e.g., a Nikon TE2000-S) and a digital camera (e.g., a
Spot RT digital camera).
[0274] Histology and Microscopy
[0275] To assess structural and compositional features of nasal
septum cartilage after exposure to the solution, RF exposure, and
post-exposure culture, a separate subset of samples are fixed in
neutral formalin and processed for histology and Fourier Transform
Infrared (FTIR) microscopy. To assess collagen structure in nasal
cartilage samples, fixed samples are embedded in paraffin, cut into
thin sections, and dewaxed in three xylene baths for 2 minutes
each, rehydrated in three baths of ethyl alcohol (100%, 95%, and
70% ethanol, respectively, appropriately diluted with distilled
water) for 2 minutes each, and dyed with Picrosirius red for 1
hours. This histochemical staining selectively binds to fibrillar
collagen, enhancing tissue birefringence. Once prepared, samples
are placed on a bright-field microscope with a 4.times. objective
and two independently rotating linear polarizers set 90.degree.
apart. Incident light is polarized, passed through the sample, and
then passed through a second polarizer, producing a map of the
local birefringence.
[0276] FTIR microscopy is used measure the local composition of
proteoglycan and collagen within these samples, as described by our
group previously. See, e.g., Silverberg et al, Structure-Function
Relations and Rigidity Percolation in the Shear Properties of
Articular Cartilage, Biophysical Journal, vol. 107, pp. 1721-1730
(2014), incorporated herein by reference for any and all purposes.
Sections, 4 mm thick from each tissue sample, are be placed on
2-mm-thick mid-infrared (IR) transparent BaF.sub.2 disks that are
25 mm in diameter. Sections are dewaxed and rehydrated as described
above. Samples are loaded into a Fourier transform infrared imaging
(FTIR-I) microscope (e.g., a Hyperion 2000 FTIR-I microscope) in
transmission mode set to acquire data on wavenumbers between 600
cm.sup.-1 and 4000 cm.sup.-1 with a resolution of 4 cm.sup.-1. A
15.times. objective is used with a slit aperture configured to
acquire spectra over a rectangular region 25.times.200 mm.sup.2.
Fifteen background-corrected scans are repeated at a given
measurement point and averaged to generate a single IR spectra. The
acquisition window is translated along the tissue thickness by a
computer-controlled stage to acquire measurements at 80 points
spaced 25 mm apart.
[0277] The two primary solid-matrix contributions to nasal septum
come from type II collagen and aggrecan. Hence, pure compound
spectra where both compounds were extracted from bovine articular
cartilage is used. Each spectra is fit to a linear combination of a
type II collagen spectrum, an aggrecan spectrum, and a linear
baseline over the spectral window from 900 cm.sup.-1 to 1725
cm.sup.-1. The final product of this fit is a local map of collagen
and proteoglycan concentration in solution- and RF-treated
cartilage, which enables the determination of any compositional
changes induced by these treatments.
[0278] Confocal Elasography
[0279] To assess the individual and combined effects of solution
treatment and RF energy delivery to cartilage on the local
mechanical properties of cartilage, grid-resolution automated
tissue elastography (GRATE) is used to map local strains in repair
cartilage. See, e.g., Buckley et al, High-Resolution Spatial
Mapping of Shear Properties in Cartilage, J. Biomechanics, vol. 43,
pp. 796-800 (2010); see also Buckley et al, Mapping the Depth
Dependence of Shear Properties in Articular Cartilage, J
Biomechanics vol. 41, pp. 2430-2437 (2008), each incorporated
herein by reference for any and all purposes. For this analysis,
samples of bovine septal cartilage obtained from experiments
described above is cut longitudinally exposed to 7 .mu.g/mL
5-dichlorotriazinylaminofluorescein (5-DTAF) for 2 hours to
uniformly stain the extracellular matrix. Samples are placed in a
tissue deformation imaging stage (TDIS) and mounted on an inverted
confocal microscope (e.g., the Zeiss LSM 510) where gridlines with
a spacing of 50 .mu.m are photobleached on the sample using a 488
nm laser. A series of steps in compressive strain are imposed on
the sample via the TDIS, and at each compressive strain, a series
of sinusoidal shear displacements are imposed on the sample at
frequencies ranging from 0.001 Hz to 1 Hz. During the application
of compressive and shear displacements, load cells mounted on the
TDIS will record the resultant forces. Simultaneous to this, images
of the sample are acquired at 20 Hz. Using custom image analysis
MATLAB code, the intensity minima corresponding to the location of
the photobleached lines is tracked, and the local strains are
determined from the slopes of these photobleached lines. At 20
.mu.m layers through the tissue the local modulus are calculated
from the measured loads and local strains.
[0280] The result of these studies is a characterization of the
treatment of nasal septum cartilage that change the shear
properties of the tissue. This technique enables the description of
the strain field on a length scale of 20 .mu.m.times.20 .mu.m,
which is on the order of 1% of the tissue thickness. This data
combined with that obtained from histological will gives insight
into how cartilage reshaping techniques affects the local structure
and properties of the tissue.
[0281] Although emphasis has been placed on structure and function
of the nasal septum in much of the foregoing description,
modifications of other cartilage or tissue may also be performed
based on the above disclosures. This may include, but need not be
limited to hyaline or other cartilage located in a subject's nose,
larynx, trachea, bronchi, airways, ribs, bones, joints, and other
locations.
[0282] Although this invention has been disclosed in the context of
certain preferred embodiments and examples, it will be understood
by those skilled in the art that the present invention extends
beyond the specifically disclosed embodiments to other alternative
embodiments and/or uses of the invention and obvious modifications
and equivalents thereof. Thus, it is intended that the scope of the
present invention herein disclosed should not be limited by the
particular disclosed embodiments described above, but should be
determined only by a fair reading of the claims that follow.
* * * * *