U.S. patent application number 16/715704 was filed with the patent office on 2020-10-08 for methods and devices for treating sleep apnea and snoring.
The applicant listed for this patent is Linguaflex, Inc.. Invention is credited to Ira Sanders.
Application Number | 20200315839 16/715704 |
Document ID | / |
Family ID | 1000004905675 |
Filed Date | 2020-10-08 |
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United States Patent
Application |
20200315839 |
Kind Code |
A1 |
Sanders; Ira |
October 8, 2020 |
Methods and Devices for Treating Sleep Apnea and Snoring
Abstract
A method for treating a breathing disorder, the method includes
providing a tissue retractor that has a shaft having a first end
and a second end, an anchor member attached to one of the first end
or the second end, and a retractor member attached to the other of
the first end or the second end, and inserting the shaft through a
soft tissue of a patient's soft palate, wherein the tissue
retractor distributes a force on the soft palate thereby changing a
size, a stiffness, and/or a shape of the patient's soft palate and
preventing obstruction of the patient's airway.
Inventors: |
Sanders; Ira; (Oakland,
NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Linguaflex, Inc. |
Pittsburgh |
PA |
US |
|
|
Family ID: |
1000004905675 |
Appl. No.: |
16/715704 |
Filed: |
December 16, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11672019 |
Feb 6, 2007 |
10524954 |
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16715704 |
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10597590 |
Jul 31, 2006 |
8925551 |
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PCT/US2005/006430 |
Feb 28, 2005 |
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11672019 |
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60547897 |
Feb 26, 2004 |
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60765638 |
Feb 6, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/00 20130101; A61B
2017/0417 20130101; A61F 5/566 20130101; A61B 17/0401 20130101;
A61B 2017/248 20130101; A61B 2017/306 20130101; A61B 2017/0419
20130101; A61B 2017/06052 20130101; A61B 2017/0496 20130101; A61B
2017/308 20130101 |
International
Class: |
A61F 5/56 20060101
A61F005/56; A61B 17/04 20060101 A61B017/04; A61F 2/00 20060101
A61F002/00 |
Claims
1. A method of treating a breathing disorder, the method
comprising: providing a tissue retractor comprising: a shaft having
a first end and a second end; an anchor member attached to one of
the first end or the second end; and a retractor member attached to
the other of the first end or the second end; and inserting the
shaft through a soft tissue of a patient's soft palate; wherein the
tissue retractor distributes a force on the soft palate thereby
changing a size, a stiffness, and/or a shape of the patient's soft
palate and preventing obstruction of the patient's airway.
2. The method of claim 1, wherein the force thins the patient's
soft palate.
3. The method of claim 1, wherein the force retracts and shortens
the patient's soft palate.
4. The method of claim 1, wherein the force stiffens the patient's
soft palate.
5. The method of claim 1, wherein the tissue retractor is
positioned along the mid-line of the soft palate.
6. The method of claim 1, wherein the anchor member is positioned
on an exterior surface of the soft palate on one of an inferior
oral side of the soft palate and a superior pharyngeal side of the
soft plate and the retractor member is positioned on the exterior
surface of the soft palate on the other of the inferior oral side
of the soft palate and the superior pharyngeal side of the soft
plate.
7. The method of claim 1, wherein the anchor member is positioned
at one of an end of the soft palate adjacent the patient's hard
palate and an end of the soft palate adjacent to or in the uvular
area, and the retractor member is positioned at the other of an end
of the soft palate adjacent the patient's hard palate and an end of
the soft palate adjacent to or in the uvular area.
8. The method of claim 1, wherein the anchor member is positioned
on an exterior surface of an inferior oral side of the soft palate
at an end of the soft palate adjacent the patient's hard palate,
the shaft passes through the soft palate, and the retractor member
is positioned on an exterior surface of a superior pharyngeal side
of the soft palate in the uvular area.
9. The method of claim 1, wherein the anchor member is positioned
on an exterior surface of a superior pharyngeal side of the soft
palate at an end of the soft palate adjacent the patient's hard
palate, the shaft passes through the soft palate, and the retractor
member is positioned on an exterior surface of an inferior oral
side of the soft palate in the uvular area.
10. The method of claim 1, further comprising connecting a
removably attachable adjustment member to the tissue retractor,
wherein the attachment of the adjustment member changes the force
that is provided to the soft palate by the tissue retractor,
rotates the soft palate, or indents the soft palate.
11. The method of claim 10, wherein the adjustment member is a
bolster disposed between the anchor member an external surface of
the soft palate.
12. The method of claim 11, wherein the bolster includes a recess
to accommodate the anchor member such that, after connection of the
anchor member to the bolster, the combination of the anchor member
and the bolster has a smooth and continuous surface.
13. The method of claim 10, wherein the anchor member is positioned
on the inferior oral side of the soft palate.
14. The method of claim 1, further comprising attaching the anchor
member to a connection member located in the oral cavity of the
patient.
15. The method of claim 14, wherein the anchor member is positioned
on the inferior oral side of the soft palate or the superior
pharyngeal side of the soft palate.
16. The method of claim 14, wherein the connection member is a
dental appliance.
17. The method of claim 1, wherein the shaft extends through the
soft palate in a direction extending from an area adjacent the hard
palate to an area adjacent the pharynx.
18. The method of claim 1, wherein the anchor member and the
retractor member are aligned on opposite sides of the soft palate
such thereby compressing and thinning the soft tissue of the soft
palate.
19. The method of claim 1, wherein the tissue retractor is totally
implanted within the soft tissue of the soft palate.
20. The method of claim 1, further comprising at least one
restraining shaft connected to the anchor member and the retractor
member, wherein the restraining shaft passes around an exterior
edge of the soft palate to maintain the position of the anchor
member and the retractor member with respect to the shaft and the
soft palate.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 11/672,019, Feb. 6, 2007, which is a
continuation-in-part of U.S. patent application Ser. No.
10/597,590, filed Jul. 31, 2006 (now U.S. Pat. No. 8,925,551),
which is a national stage filing, under 35 U.S.C. .sctn. 371 of
International Patent Application No. PCT/US2005/006430, filed Feb.
28, 2005, which claims the benefit of U.S. Provisional Patent
Application No. 60/547,897, filed Feb. 26, 2004. U.S. patent
application Ser. No. 10/597,590, filed Jul. 31, 2006, also claims
the benefit of U.S. Provisional Patent Application No. 60/765,638,
filed on Feb. 6, 2006. All of these priority applications are
hereby incorporated by reference herein.
FIELD OF THE INVENTION
[0002] This invention relates to methods and devices for
maintaining upper airway patency.
BACKGROUND OF THE INVENTION
[0003] Snoring, upper airway resistance syndrome, and obstructive
sleep apnea syndrome (OSAS) are all related to narrowing or
obstruction of the upper airway during sleep (sleep disordered
breathing). According to the National Institutes of Health (NIH),
approximately 18 million Americans have sleep apnea (sleep
disordered breathing), but fewer than 50% are presently being
diagnosed. According to the National Highway Traffic and Safety
Administration (NHTSA), 100,000 accidents and 1,500 traffic
fatalities per year are related to drowsy driving. More than 50% of
Americans over age 65 have sleep difficulties, and prevalence of
sleep problems will therefore increase as the over-65 population
increases. Each year, sleep disorders, sleep deprivation, and
excessive daytime sleepiness add approximately $16 billion annually
to the cost of health care in the U.S., and result in $50 billion
annually in lost productivity.
Pathophysiology of Sleep Disorders
[0004] Sleep disorders are largely caused by too much soft tissue
in the throat. Humans are unique because their upper airway has a
curved shape, an anatomical change that is related to the evolution
of human speech. As a result the upper airway of humans is more
flexible than that of other species and is more prone to collapse
under negative pressure. In the awake state a certain amount of
tone is present in upper airway muscles to prevent this collapse.
However, during sleep muscle tone decreases in upper airway muscles
and in certain susceptible individuals this relaxation allows the
airway to collapse (Horner R L. Motor control of the pharyngeal
musculature and implications for the pathogenesis of obstructive
sleep apnea. Sleep 1996; 19: 827-853).
[0005] The upper airway refers to the air filled spaces between the
nose and the larynx (FIG. 1). The most relevant part of the upper
airway for sleep disorders is the air cavity at the back of the
throat called the pharynx. The pharynx can be divided into three
anatomical levels (FIG. 2):
[0006] 1) The nasopharynx is the part of the pharynx in the back of
the nasal cavity.
[0007] 2) The part at the back of the mouth is called the
oropharynx. To be more precise it is best called the velopharynx.
This level corresponds to that part of the pharynx containing the
velum (soft palate) and tongue curve.
[0008] 3) The hypopharynyx is behind the tongue base.
[0009] The velopharynx is more susceptible to collapse because
there are more soft tissue structures, leaving less room for
airflow. The major structures of the velopharynx are the soft
palate and the tongue, both of which are very flexible. The soft
palate acts as a barrier between the mouth and the nose. In many
people it is longer than necessary and extends down between the
tongue and pharyngeal wall. The tongue is the largest muscular
organ of the upper airway and is anatomically divisible into a
blade, body and base (FIG. 3). Most of the tongue's curve is at the
junction of the tongue body and base.
[0010] In the awake condition the structures of the velopharynx
maintain their shape because of continuous tone of their internal
muscles. When this tone decreases, such as during sleep, these
structures become quite flexible and distensible. Without the
normal muscle tone that keeps them in place, they tend to collapse
at relatively low negative pressures. Although muscles relax
throughout the body during sleep many of the respiratory muscles
remain active. Specifically the major muscle that pulls the tongue
forward, the genioglossus muscle, has been reported to show normal
or increased activity during obstructive apneas. Normally the
genioglossus is capable of moving the tongue forward and even
projecting it out of the mouth. Why the genioglossus muscle
sometimes fails to prevent obstructions has not been explained.
[0011] During inspiration the chest wall expands and causes
negative pressure to draw air into the nose and mouth and past the
pharynx into the lungs. This negative pressure causes upper airway
soft tissue to deform, further narrowing the airway. If the airway
narrows enough the air flow becomes turbulent causing the soft
palate to vibrate. The vibration of the soft palate produces the
sound known as snoring. Snoring is extremely common effecting up to
50% of men and 25% of women. By itself snoring is not a medical
problem although it can be a tremendous problem for the patient's
bed partner and a major cause of marital strain.
[0012] A small amount of decreased airflow or brief obstructions
occur in all humans during sleep. These episodes are counted as
medically significant if airflow is decreased more than 50% of
normal (hypopnea) or if airflow is obstructed for more than 10
seconds (apnea). The number of apneas and hypopneas that occur
during each hour of sleep is measured to diagnose the severity of
the sleep disorder. These episodes of hypopnea or apnea often cause
some degree of arousal during sleep. Although the patient does not
awaken to full consciousness, the sleep pattern is disturbed
causing the patient to feel sleepy during the day. If the frequency
of hypopnea or apnea is more than 5 episodes an hour it is called
upper airway resistance syndrome. These patients often show
symptoms related to the sleep disruption. Specifically, these
patients are excessively sleepy during the day. In addition more
subtle symptoms such as depression and difficulty in concentrating
are also commonly reported.
[0013] Technically the diagnosis of OSAS is defined as an average
of more than 10 episodes of hypopnea or apnea during each hour of
sleep. Although the airway is obstructed the patient makes repeated
and progressively more forceful attempts at inspiration. These
episodes are silent and characterized by movements of the abdomen
and chest wall as the patient strains to bring air into the lungs.
Episodes of apnea can last a minute or more, and during this time
the oxygen levels in the blood decrease. Finally, either the
obstruction is overcome, usually producing a loud snore, or the
patient awakes with the feeling of choking.
[0014] Very common symptoms in OSAS patients are morning headaches
and acid reflux. During airway obstructions the forceful attempts
to inspire air can cause tremendous negative pressure in the chest.
These high negative pressures can draw acid up the esophagus from
the stomach. The acid can travel all the way into the mouth and
cause inflammation of the vocal cords and nasal mucosa. The
presence of the acid in the upper airway causes reflex
bronchoconstriction in the lung that is similar to an asthma
attack. If even a small amount of acid enters the lung it can cause
the vocal folds to close tightly and itself cause a prolonged apnea
called laryngospasm. In many patients the repeated stretching of
the espophageal sphincter causes chronic changes and these patients
can have acid reflux during the day.
[0015] Most importantly, sleep disorders can cause serious medical
disorders and death. Apneas cause a large strain on the heart and
lungs. Over time the many repeated episodes of apnea cause chronic
changes leading to hypertension. Long periods of apnea allow the
oxygen levels in the blood to decrease. In turn the low oxygen can
cause heart attacks or strokes.
Treatment of Sleep Disorders
[0016] Although OSAS occurs in both children and adults the cause
and treatment is very different. OSAS in children almost always
occurs when the child has large tonsils, and tonsillectomy cures
the condition. Tonsils naturally decrease in size with age and are
rarely a problem in adults. Instead susceptible adults usually have
enlargement of their tongues, soft palate and/or pharyngeal walls.
This enlargement is mostly due to fat deposits within these
structures.
[0017] Adult sleep disorders are difficult to treat for a variety
of reasons. The upper airway is a very mobile structure that
performs the critical functions of swallowing and speech. These
functions are easily compromised by surgical procedures or other
interventions. In addition, the upper airway also has a large
amount of sensory innervation that causes reflex gagging and
coughing. Theoretically a physical stent that is placed in the oral
cavity and pharynx would be completely effective in relieving sleep
apnea. When a patient is totally unconscious, such as when they are
anesthetized for surgery, the airway can be stented open by placing
a curved oral tube into the mouth and pharynx. In addition,
endotracheal tubes establish a secure airway for artificial
ventilation. However, after anesthesia wears off, patients
immediately sense and react to the foreign objects in their throats
and expel them. Therefore devices such as oral and endotracheal
tubes, or anything similar, cannot be used for the treatment of
OSAS.
[0018] Although physical stents cannot be used for OSAS an indirect
way of stenting the upper airway with positive air pressure is the
most common prescribed treatment for OSAS. This method is called
continuous positive airway pressure (CPAP). CPAP requires the use
of a mask tightly attached around the nose and connected to a
respirator. The exact amount of positive pressure is different for
each patient and must be set by overnight testing using multiple
pressures. The positive pressure acts like a stent to keep the
airway open. CPAP is not a cure but a therapy that must be used
every night. Although many OSAS patients are helped by CPAP it is
not comfortable for the patient or their bed partner. Patients
often cannot tolerate the claustrophobic feeling of a mask tightly
attached to their face. In addition there are often many technical
problems with maintaining a proper seal of the mask to the face.
For these reasons up to half of all patients who are prescribed
CPAP stop using it within 6 months (Sanders, "Medical Therapy for
Sleep Apnea," Principles and Practice of Sleep Medicine, 2nd
Edition, pp. 678-684).
Tracheotomy
[0019] The only completely effective surgical therapy for OSAS is
to bypass the entire upper airway by performing a permanent
tracheotomy, a surgical procedure that forms a direct connection to
the trachea through the neck. This is a dangerous procedure
reserved for the worst cases when there is a high risk of serious
medical complications from OSAS. Notably, temporary tracheotomies
are often performed on patients with severe OSAS to control the
airway before any other procedure is performed on their upper
airway. The reason is that these patients are at high risk of acute
airway obstruction and death if there is any swelling in their
airways. Due to the tremendous excess of swollen tissue in their
upper airways OSAS patients are very difficult to intubate under
emergency conditions. Similarly there is tremendous amount of fat
in the neck that makes emergency tracheotomies extremely
hazardous.
[0020] Prior to current conservative measures, post operative
deaths were not uncommon in severe OSAS patients. Moreover these
patients often have acclimated to breathing against resistance, and
when the resistance is suddenly removed their respiratory drive
decreases. Even today the standard of care in treating most OSAS
patients is to have them under close observation in an intensive
care unit or recovery room after surgical procedures.
Soft Palate Procedures for Snoring
[0021] As the soft palate vibrates more than other tissues it plays
a disproportional role in snoring. Various surgical therapies are
available that shrink or stiffen the soft palate. The main
procedure used is called uvulopalatopharyngoplasty (UPPP). UPPP
excises excess soft tissue of the pharyngeal walls and soft palate
with a surgical scalpel. Because so much mucosa of the pharyngeal
area is traumatized during a UPPP there is a large amount of post
operative swelling and severe pain. In selected patients who snore
but have no obstructions more limited versions of the UPPP can be
done with lasers or electrical cautery.
[0022] Newer procedures minimize trauma to the mucosa and use
needles to reach the underlying soft tissue to shrink its volume or
stiffen it so that it resists vibration. Electrodes can be inserted
into the soft palate to deliver radiofrequency energy that shrinks
or stiffens the palate (Powell, N B, et al (1998) Radiofrequency
volumetric tissue reduction of the palate in subjects with
sleep-disordered breathing. Chest 113, 1163-1174.) (Somnoplasty;
Somnus; Mountainview, Calif.). Mild caustic agents can be injected
that decrease the volume of the soft palate. U.S. Pat. No.
6,439,238 to Benzel teaches the application of a stiffening agent
to the surface of the soft palate. Most recently, office based
implantation of plastic inserts to stiffen the soft palate has been
approved by the FDA (Pillar.RTM. Procedure, U.S. Pat. No.
6,546,936: Method and apparatus to treat conditions of the
naso-pharyngeal area).
[0023] The fundamental shortcoming of all procedures that target
the soft palate, including the newer techniques, is that they only
partially improve OSAS (Loube D I (1999) Technologic Advances in
the Treatment of Obstructive Sleep Apnea Syndrome. Chest. 1999;
116:1426-1433, Doghramji, K, et al (1995) Predictors of outcome for
uvulopalatopharyngoplasty. Laryngoscope 105, 311-314). Although
studies report a decrease in the number of apneas these patients
are rarely cured. Evidently the critical structure causing OSAS is
not the soft palate but the tongue.
Tongue Base Procedures for OSAS
[0024] The methods used to treat the tongue base in OSAS are either
to permanently decrease its volume, to decrease its flexibility or
to move the entire tongue forward.
[0025] Surgical excision of the tongue base has been poorly
effective. The results for scalpel or laser resection of the tongue
base in OSAS treatment have not been good enough to recommend
continued application of these procedures (Mickelson, S A,
Rosenthal, L (1997). Midline glossectomy and epiglottidectomy for
obstructive sleep apnea syndrome. Laryngoscope 107, 614-619).
[0026] More recently radiofrequency (U.S. Pat. No. 5,843,021 to
Edwards) and ultrasonic (U.S. Pat. No. 6,409,720) energy have been
proposed to shrink and stiffen the tongue base with radiofrequency
energy. The radiofrequency energy is delivered via needle
electrodes that are inserted into the tongue base to cause a lesion
that scars and shrinks over time. To avoid postoperative swelling
and pain a limited amount of lesioning is done in a single session
and patients require an average of 5 treatments. About a third of
patients have greater than 50% improvement in their OSAS. However,
approximately a fourth of patients have significant post operative
complications, including, tongue base ulceration and abscesses, and
temporary tracheotomy.
[0027] A recent introduced device for tongue base advancement is
the Repose.RTM. system (Influent Corp; San Francisco, Calif.). The
Repose.RTM. procedure is performed under general anesthesia, and a
screw is inserted at the base of the mandible. The screw contains
attachments for a permanent suture that is tunneled under the
mucosa of the floor of the mouth to the back of the tongue, then
passed across the width of the tongue base, and brought back to
attach to a metal hook screwed into the bone of the mandible. The
suture is tightened to displace the tongue base forward, and
caution must be observed to prevent excess tension leading to
necrosis of tissue. Unfortunately studies of the Repose.RTM.
procedure show that it is ineffective at eliminating OSAS. Only 1
of 15 patients was cured of OSAS while 2 patients had to have the
suture removed due to pain and swelling.
[0028] More aggressive surgical procedures require reconstruction
of the mandible, facial, skeleton or the hyoid bone. An example of
the art is U.S. Pat. No. 6,161,541 to Woodson that teaches a method
of surgically expanding the pharyngeal airway. These procedures
require extensive surgery with higher risks and much longer
recovery periods.
[0029] Other proposed methods for treating the tongue base include
stiffening the soft tissue by injection of sclerosing particles
U.S. Pat. No. 6,742,524 or other implanted material U.S. Patent
Application Publication No. 20050004417A1.
Neuroprosthetic Devices
[0030] Various neuroprosthetic devices have been invented that
stimulate upper airway muscles. U.S. Pat. No. 4,907,602 to Sanders
describes transmucosal stimulation to dilate the airway; U.S. Pat.
No. 5,792,067 to Karell teaches an intraoral device that applies
electrical stimulation to the hard palate, soft palate or
pharyngeal area to induce contraction of the upper airway muscles;
U.S. Pat. No. 5,190,053 to Meer teaches an intraoral device that
applies electrical stimulation to the genioglossus muscle via
electrodes located on the mucosa on the floor of the mouth on
either side of the frenulum. In addition U.S. Pat. No. 5,591,216 to
Testerman describes a totally implantable device to stimulate the
nerves to the genioglossus muscles. In addition, WIPO Publication
No. 04064729 to Gordon describes a neuroprosthetic device that can
be injected into the soft palate to treat snoring. At present these
devices have not been clinically proven.
[0031] In summary, sleep disorders are a significant health problem
without an acceptable solution and there is a need in the art for
new and more effective therapies.
[0032] While not wishing to be bound by theory my studies of human
tongue anatomy suggest that episodes of obstruction evolve by a
sequence of events (FIGS. 4A-4G). The initial inciting event is the
deformation of a relatively small part of the tongue. Under certain
conditions deformation begins in soft tissue on the top of the
tongue, particularly in the area of the tongue curve, and
specifically near the center line of the tongue curve. As this
tissue deforms it narrows the airway and causes more negative
pressure thereby causing greater deformation. This feedback cycle
in turn deforms enough tissue in the area to cause a complete
obstruction in the velopharyngeal area.
[0033] If an initial obstruction occurs near the end of
inspiration, the obstruction is relieved by an expiration, or by
action of the genioglossus muscle. However, if the obstruction
occurs at the beginning of inspiration reflexes trigger stronger
inspiratory effort that further lowers airway pressure. This
increased negative pressure causes deformation and collapse of most
of the tongue base. At this point the airway is firmly plugged by
soft tissue and activity of the genioglossus only stretches the
tongue tissue that is plugged and cannot dislodge it.
[0034] Therefore the tongue curve is the critical area that
initiates the cascade leading to obstruction. This relaxed muscle
is very flexible and easy to deform, however, the converse is also
true, very little force is needed to prevent this deformation.
Therefore if sufficient counterforce is exerted at the proper
localized area of the tongue it can prevent obstruction without
noticeable effects on speech and swallowing movements.
[0035] How a device could prevent the deformation and collapse of
the tongue curve is not a trivial problem: [0036] This area of the
tongue is very mobile during speech and swallowing, therefore the
amount of force exerted must be low and highly localized. It is
unacceptable to render the area immobile, as would be done if were
stiffened by a large implant or scar tissue, [0037] The whole area
of the velopharynx has extensive sensory innervation, and
relatively minor stimulation there causes either a gag or a
swallow. [0038] The tongue base and body have a larger blood supply
than comparable muscles elsewhere in the body. Any implant placed
in the area has a high probability of causing internal bleeding
with potentially catastrophic tongue swelling. [0039] Soft tissue
and tongue in particular remodel easily. Specifically sutures or
implants that exert force cause the tissue to remodel to relieve
that force. This is known as the cheese cutter effect. Therefore
the forces applied must be relatively low and applied for limited
periods. [0040] Humans' upper airway anatomy is highly variable,
and the pathological anatomy of sleep apnea patients is even more
variable. Moreover the upper airway anatomy of sleep apnea patients
changes over time as the disease progresses or improves. [0041]
Finally, OSAS patients have borderline airways that can obstruct
after even minor amounts of swelling such as that following
surgical manipulation. Therefore it is not obvious how a device
could both exert force in the area yet avoid swelling.
[0042] Moreover to be maximally effective and get patient and
physician acceptance the device would ideally require additional
qualities: [0043] It should be capable of being inserted as an
outpatient procedure. [0044] Preferably the device could he removed
during the day and reinserted by the patient at night. [0045] It
would be adjustable to conform to the specific needs of the
patient. [0046] It would be comfortable for the patient. [0047]
When the device was in place it would not be noticeable to anyone
else.
SUMMARY OF THE INVENTION
[0048] There is a tremendous variability in human upper airway
anatomy, and even further variation in the pathological changes
contributing to sleep apnea and related disorders. Moreover, the
pathological anatomy changes over time in each patient as their
condition improves or deteriorates. No single method and device is
able to treat all contingencies. Therefore there is a critical need
for methods and devices that are optimized for different sites in
the upper airway.
[0049] Embodiments of the invention include methods and devices to
prevent or treat upper airway disorders in mammals related to
impaired airflow. These disorders are, without limitation, snoring,
upper airway resistance syndrome, and obstructive sleep apnea. In
addition, this invention is applicable to airway disorders in
animals including but not limited to dorsal displacement of the
soft palate in horses and brachycephlic obstructive airway syndrome
in certain breeds of dog. Those skilled in the art will readily
appreciate that application of this invention can be applied to
other conditions of the upper airway.
[0050] One aspect of the invention prevents airway obstruction by
dilating the airway or preventing the tissue from deforming. It
enlarges the airway when excess tissue is present and also
counteracts the deforming influence of negative airway pressure on
the relaxed soft tissue of upper airway structures. These
structures include, without limitation, the tongue, soft palate,
pharyngeal walls and supraglottic larynx.
[0051] PCT Publication No. WO 2005/082452 describes one embodiment
of the method and device herein referred to as a Linguaflex tongue
retractor (LTR), notwithstanding that the use of the device as
disclosed herein is not limited to the tongue or to retraction. The
LTR consists of a retractor (R), a shaft (S), and an anchor (A). In
a preferred embodiment a retractor is physically coupled to the
soft tissue of the tongue base. The shaft passes through the
midline of the tongue to connect with an anchor. The anchor imparts
counterforce through the shaft to the retractor, thereby preventing
deformation of the soft tissue.
[0052] One aspect of this invention describes improvements to the
retractor head, shaft and anchor that increase the efficacy of the
device while decreasing patient discomfort. Improvements of the LTR
components include but are not limited to a retractor head that
collapses to fit within a narrow delivery device and expands after
insertion; a shaft that passively adjusts its length and tension in
response to surrounding tongue activity; and a modified anchor that
is adjustable by the patient and attaches to a soft bolster, a
partially implanted receptacle in the mouth, and/or a dental
appliance.
[0053] One aspect of the invention is a method of making the
implant more comfortable by allowing the device to be under little
or no tension during the day, the unloaded state, and to increase
the tension to therapeutic levels at night, the loaded state. This
method increases the comfort for the patient and allows the patient
a large degree of control. The method and the devices that
implement the method are of great importance as the lack of patient
compliance is perhaps the largest problem with current sleep apnea
therapies.
[0054] Another aspect of this invention is that additional sites in
and around the tongue can unexpectedly be treated with this
invention to prevent airway disorders. Non-limiting examples of
these sites are the base of tongue, the mucosa covering the tongue,
the tongue frenulum, the pharyngoglossal, palatoglossal and
aryepiglottic folds, the lateral pharyngeal wall and soft palate.
An improved LTR applied to these sites directly or indirectly
stiffens and displaces the tongue base, soft palate and lateral
pharyngeal walls and enlarges the velopharynx. Each site has
specific anatomy for which novel and unexpected improvements to the
LTR allow it to perform efficiently with minimal risk and
discomfort to the patient.
[0055] One aspect of this invention is an LTR that indirectly
retracts tongue base by its implant site in the frenulum area. This
simplifies the insertion, adjustment and maintenance of the
device.
[0056] Another aspect of this invention describes a highly
localized and fully implantable LTR that is inserted into the base
of the tongue to stiffen lax surface mucosa or mechanically couple
it to internal tongue structures.
[0057] Another aspect of this invention is an LTR inserted in or
around the pharyngoglossal fold. This site allows retraction and
stiffening of tongue base tissue as well as the soft palate and
lateral pharyngeal wall. The advantage of this site is its minimal
invasiveness, safety and its beneficial effect on multiple
different structures.
[0058] Another aspect of this invention is a method and device to
remodel upper airway tissue in order to enlarge the pharyngeal
airspace. Tissues remodeled include but are not limited to tongue
base, palatine tonsil, pharyngeal wall and soft palate. Preferably
these tissues are either compressed to decrease their volume, or
displaced or reshaped. This effect lasts months to years after the
devices have been removed. To achieve this persistent beneficial
effect, devices would preferably exert force preferably from 1 week
to 1 year, more preferably for 1 to 6 months.
[0059] Another aspect of this invention are non-invasive methods
and devices that reversibly couple to mucosa to grasp, move and/or
reposition soft tissue using magnets, adhesives, vacuum, and/or
mechanical leverage. In one embodiment a curved retractor member is
reversibly inserted into selected sites. In another embodiment
indwelling clips are placed on the PGF, tonsillar folds, soft
palate and other soft tissue folds. These retractor members can be
loaded as needed by coupling them to modified anchors in or outside
the mouth. In still another embodiment the floor of mouth is
protracted to displace the tongue base. In a still further
embodiment a vacuum reshapes the tongue to decrease base of tongue
volume.
[0060] Another aspect of this invention describes LTRs specifically
adapted to prevent dorsal displacement of the soft palate in
horses.
[0061] In each site the LTR has multiple embodiments. The LTR can
pass through tissue and have its retractor or anchor ends outside
of tissue, or have only one end exposed, or the entire device can
be implanted. The shaft of the device can pass deeply into the
tissue, or pass superficially just beneath the mucosa. The
retractor and anchor member is preferably shaped to fit its site so
as to distribute force evenly: flat for flat or mildly curved
surfaces such as the mid tongue base, pharyngeal wall, and soft
palate; wedge shaped for the depths of the pharyngoglossal fold and
lateral margin of the soft palate; V shaped for the frenulum; and T
shaped for the teeth. The materials of the implant, retractor and
anchor could be of any of the well known non-reactive biocompatible
materials known in the art. Non-limiting examples of rigid
materials include stainless steel, titanium, ceramics, and
plastics. Elastomeric materials include silicon and rubber. The
force needed to displace the tongue anteriorly or the soft palate
superiorly varies from 0.001 gram to 10,000 grams. More preferable
0.1 gram to 1000 grams, most preferably 10-100 grams. This force
could be applied from 0.01 sec to permanently. More preferable one
minute to 1 month. Even more preferably for the duration of sleep.
Most preferably during episodes of restricted upper airway
flow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0062] The present invention will be more readily understood from
the detailed description of exemplary embodiments presented below
considered in conjunction with the attached drawings, of which:
[0063] FIG. 1 is a side cross-sectional view of the human upper
airway in the mid saggital plane;
[0064] FIG. 2 is a simplified schematic side cross-sectional view
of the tongue and surrounding structures;
[0065] FIG. 3 is a side cross-sectional view showing anatomical
landmarks of the tongue;
[0066] FIG. 4A shows a side cross-sectional view of the tongue of a
patient that is awake;
[0067] FIG. 4B shows a side cross-sectional view of the tongue of a
patient with apnea;
[0068] FIG. 4C shows a side cross-sectional view of the tongue of a
patient with apnea after the airway has been obstructed;
[0069] FIG. 4D shows a side cross-sectional view of the tongue of a
patient using a CPAP device for treating sleep apnea;
[0070] FIG. 4E shows a side cross-sectional view of the tongue of a
patient using a prior art dental device for treating sleep
apnea;
[0071] FIG. 4F shows a side cross-sectional view of the tongue of a
patient using an embodiment of the inventive tissue retractor;
[0072] FIG. 5A shows a side view of an embodiment of the inventive
tissue retractor;
[0073] FIG. 5B shows a side cross-sectional view of the tissue
retractor shown in FIG. 5A implanted in the tongue;
[0074] FIG. 5C shows a back view of the tongue curve with the
tissue retractor shown in FIG. 5A implanted in the tongue;
[0075] FIG. 5D shows a back view of the tongue base with the tissue
retractor shown in FIG. 5A implanted in the tongue;
[0076] FIG. 6A shows a front view of one embodiment of a retractor
of the inventive tissue retractor;
[0077] FIGS. 6B and 6C show a side view of the retractor shown in
FIG. 6A;
[0078] FIG. 6D shows a front view of the retractor shown in FIG.
6A;
[0079] FIG. 6E shows a side view of an inventive tissue retractor
having the retractor shown in FIGS. 6A-6D mounted within a
needle;
[0080] FIG. 6F shows a side view of the needle shown in FIG. 6E
passing through tissue;
[0081] FIG. 6G shows a side view of the needle shown in FIGS. 6E
and 6F after the needle has passed through the tissue;
[0082] FIG. 6H shows a side view of the position of the retractor
shown in FIG. 6A after the inventive tissue retractor has been
implanted in the tissue;
[0083] FIG. 7A shows a cross-sectional view of an embodiment of the
inventive tissue retractor implanted in the tongue when the patient
is awake;
[0084] FIG. 7B shows a cross-sectional view of the tissue retractor
shown in FIG. 7B implanted in the tongue when the patient is
asleep;
[0085] FIG. 7C is a cross-sectional view of the tissue retractor
shown in FIG. 7A implanted in the tongue when the patient is
swallowing or speaking;
[0086] FIG. 8A shows a front view of an embodiment of a bolster of
one embodiment of the inventive tissue retractor;
[0087] FIG. 8B shows a top view of the bolster of FIG. 8A;
[0088] FIG. 8C shows a side view of the bolster of FIG. 8A;
[0089] FIG. 8D shows a side cross-sectional view of the inventive
tissue retractor implanted in the tongue without the bolster shown
in FIG. 8A;
[0090] FIG. 8E shows a side cross-sectional view of the inventive
tissue retractor implanted in the tongue with the bolster shown in
FIG. 8A being placed under the tongue;
[0091] FIG. 8F shows a side cross-sectional view of the inventive
tissue retractor implanted in the tongue with the bolster shown in
FIG. 8A in position under the tongue;
[0092] FIG. 8G shows a front view of the anchor of the inventive
tissue retractor engaging the bolster shown in FIG. 8A;
[0093] FIG. 8H shows a top view of the inventive tissue retractor
implanted in the tongue with the bolster shown in FIG. 8A in
position under the tongue;
[0094] FIG. 9A shows a top view of one embodiment of the inventive
tissue retractor;
[0095] FIG. 9B shows a top view of the tongue and the mandible with
the inventive tissue retractor shown in FIG. 9A implanted from the
tongue base to the frenulum and interacting with the front
teeth;
[0096] FIG. 9C shows a top view of another embodiment of the
inventive tissue retractor;
[0097] FIG. 9D shows a top view of the tongue and the mandible with
the inventive tissue retractor shown in FIG. 9C implanted through
the pharyngoglossal fold (PGF) and interacting with the back
teeth;
[0098] FIG. 9E shows a side cross-sectional view of another
embodiment of the inventive tissue retractor and possible coupling
extension to the soft palate, PGF, floor of mouth, and tongue
surface;
[0099] FIG. 10A shows a side cross-section of the tongue and
mandible cut in the centerline (mid-sagittal plane);
[0100] FIG. 10B shows a side cross-sectional schematic of the
tongue and mandible cut in the centerline (mid-sagittal plane);
[0101] FIG. 10C shows a side cross-sectional schematic of the
frenulum area;
[0102] FIG. 11A shows a side cross-section of the tongue and
mandible cut in the centerline (mid-sagittal plane);
[0103] FIG. 11B shows a side cross-sectional schematic of the
tongue and mandible cut in the centerline (mid-sagittal plane);
[0104] FIG. 11C shows a side cross-sectional schematic of the
tongue and mandible cut in the centerline (mid-sagittal plane) with
an embodiment of the inventive tissue retractor passing through the
frenulum area and anchored externally to a dental anchor;
[0105] FIG. 11D shows a side cross-sectional schematic of the
tongue and mandible cut in the centerline (mid-sagittal plane) with
an embodiment of the inventive tissue retractor passing through the
boundary layer and anchored to a frenulum anchor;
[0106] FIG. 11E shows a side cross-sectional schematic of the
tongue and mandible cut in the centerline (mid-sagittal plane) with
an embodiment of the inventive tissue retractor fully implanted in
the frenulum area connecting the boundary area in two places;
[0107] FIG. 12A shows a front section of the tongue base;
[0108] FIG. 12B shows a front section schematic of the tongue base
of FIG. 12A;
[0109] FIG. 12C shows a front section schematic of the tongue base
with an embodiment of the inventive tissue retractor implanted in
the soft tissue;
[0110] FIG. 12D shows the tongue as seen in the mid-sagittal
plane;
[0111] FIG. 12E shows a schematic drawing of the tongue as seen in
the mid-sagittal plane of FIG. 12D;
[0112] FIG. 12E shows a schematic drawing of the tongue as seen in
the mid-sagittal plane of FIG. 12D with the position in which the
inventive tissue retractor would be placed being shown;
[0113] FIG. 13A shows a side cross-sectional view of the tongue
with an embodiment of the inventive tissue retractor implanted in a
first position;
[0114] FIG. 13B shows a top view of the tongue of FIG. 13A;
[0115] FIG. 13C shows a side cross-sectional view of the tongue
with an embodiment of the inventive tissue retractor implanted in a
second position;
[0116] FIG. 13D shows a top view of the tongue of FIG. 13C;
[0117] FIG. 13E shows a side cross-sectional view of the tongue
with an embodiment of the inventive tissue retractor implanted in a
third position;
[0118] FIG. 13F shows a top view of the tongue of FIG. 13E;
[0119] FIG. 13G shows a side cross-sectional view of the tongue
with an embodiment of the inventive tissue retractor implanted in a
third position;
[0120] FIG. 13H shows a top view of the tongue of FIG. 13G;
[0121] FIG. 13I shows a side cross-sectional view of an embodiment
of a partially implantable anchor member for an embodiment of the
inventive tissue retractor;
[0122] FIG. 13J shows a top view of the partially implantable
anchor member of FIG. 13I;
[0123] FIG. 13K shows a side cross-sectional view of the partially
implantable anchor member shown in FIG. 13I engaged with the shaft
of the inventive tissue retractor;
[0124] FIG. 13L shows a side cross-sectional view of the partially
implantable anchor member shown in FIG. 13I with the extension of
the anchor member depressed flush with the mucosa when not in
use;
[0125] FIG. 13M shows a side cross-sectional view of the tongue
with an embodiment of the inventive tissue retractor having an
elastic sleeve implanted in a first position;
[0126] FIG. 13N shows a top view of the tongue of FIG. 13M;
[0127] FIG. 13O shows a side cross-sectional view of the tongue
with an embodiment of the inventive tissue retractor having a shaft
passing across the tongue base and connecting to a semi-implanted
retractor member;
[0128] FIG. 13P shows a top view of the tongue of FIG. 13O;
[0129] FIG. 13Q shows a side cross-sectional view of the tongue
with an embodiment of the inventive tissue retractor having a shaft
passing through the tongue blade to an intermediate anchor on the
superior surface of the tongue;
[0130] FIG. 13R shows a top view of the tongue of FIG. 13Q;
[0131] FIG. 13S shows a side cross-sectional view of the tongue
with an embodiment of the inventive tissue retractor having a rigid
shaft connecting an anchor member below the tongue blade to a
retractor member above the tongue blade;
[0132] FIG. 13T shows a side cross-sectional view of the tongue
shown in FIG. 13S with the retractor member rotated forward by a
sleeve that is reversibly placed over the tongue blade;
[0133] FIG. 14A shows a side cross-sectional view of the upper
airway;
[0134] FIG. 14B shows a side view of tongue in relation to mandible
with the area of superior PGF attachment marked;
[0135] FIG. 14C shows the palatoglossus muscle connecting the soft
palate to the superior PGF;
[0136] FIG. 14D shows the superior pharyngeal constrictor muscle
connecting the pharyngeal walls to the superior PGF;
[0137] FIG. 14E shows the retraction force of the PGF being
dispersed to the tongue base, soft palate, and lateral pharyngeal
walls;
[0138] FIG. 15A shows a side cross-sectional view of the posterior
collapse of the tongue and its effect on the airway;
[0139] FIG. 15B shows a side cross-sectional view of one embodiment
of the inventive tissue retractor implanted with a retractor at the
PGF and a shaft that passes across the frenulum to a retractor in
the other PGF;
[0140] FIG. 15C shows a side cross-sectional view of one embodiment
of the inventive tissue retractor implanted with a retractor in the
PGF and a shaft passing through tongue tissue to emerge and connect
to a modified anchor and an alternative embodiment passing through
the floor of mouth to an external anchor resting on the skin;
[0141] FIG. 15D shows a side cross-sectional view of one embodiment
of the inventive tissue retractor implanted with a retractor in or
near the PGF and a shaft passing through the tongue to an anchor
implanted in genioglossus muscle or a floor of mouth structure;
[0142] FIG. 15E shows a side cross-sectional view of one embodiment
of the inventive tissue retractor implanted with a retractor in the
superior PGF and an anchor in the inferior PGF;
[0143] FIG. 15F shows a side cross-sectional view of one embodiment
of the inventive tissue retractor implanted with a retractor in the
PGF and a shaft passing through the tongue to an anchor on the
superior surface of the tongue;
[0144] FIG. 16A shows a side cross-sectional view of one embodiment
of the inventive tissue retractor implanted with a retractor at the
tongue base connected by two sub-mucosal shafts to anchors in front
of each PGF;
[0145] FIG. 16B is a top view of FIG. 16A;
[0146] FIG. 16C shows a side cross-sectional view of one embodiment
of the inventive tissue retractor implanted with a sub-mucosal
shaft connected to two retractor/anchor members in front of each
PGF;
[0147] FIG. 16D is a top view of FIG. 16C;
[0148] FIG. 16E shows a side cross-sectional view of one embodiment
of the inventive tissue retractor implanted with two implanted
retractor/anchor members in or near the PGFs connected by a
sub-mucosal shaft;
[0149] FIG. 16F is a top view of FIG. 16E;
[0150] FIG. 16G shows a side cross-sectional view of one embodiment
of the inventive tissue retractor implanted with magnets in or near
each PGF and connected by a sub-mucosal shaft;
[0151] FIG. 16H is a top view of FIG. 16G;
[0152] FIG. 161 is a front and a side view of a magnet of one
embodiment of the inventive tissue retractor implanted in a
PGF;
[0153] FIG. 16J is a front and a side view of a magnet of one
embodiment of the inventive tissue retractor implanted in a PGF
where the magnet is enclosed in an implant that has two flanges to
keep it in place within the PGF;
[0154] FIG. 16K shows a top view of another embodiment of the
inventive tissue retractor having a hook;
[0155] FIG. 16L shows a top view of the tongue and the mandible
showing the inventive tissue retractor shown in FIG. 16K and an
alternative embodiment of the inventive tissue retractor using
magnets;
[0156] FIG. 17A shows a front view of the mouth showing the soft
palate (SP), the palatopharyngeus fold (PAPHF) and palatoglossal
folds (PAF) with various placements of embodiments of the inventive
tissue retractor;
[0157] FIG. 17B shows FIG. 17A with mucosa removed to show the
underlying muscles (right side) and the nerve and blood supply
(left side) with various placements of embodiments of the inventive
tissue retractor;
[0158] FIG. 17C shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with various placements of embodiments of the inventive
tissue retractor;
[0159] FIG. 18A shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with an embodiment of the inventive tissue retractor
implanted with the retractor on the posterior surface of posterior
tonsillar fold and the anchor on the anterior surface of anterior
tonsillar fold;
[0160] FIG. 18B shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with an embodiment of the inventive tissue retractor
implanted with the retractor superior to the palatoglossus fold and
the anchor inferior palatoglossus fold;
[0161] FIG. 18C shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with an embodiment of the inventive tissue retractor
implanted within palatoglossus muscle;
[0162] FIG. 18D shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with an embodiment of the inventive tissue retractor
implanted with the anchor at lateral aspect of soft palate and the
retractor at the midline;
[0163] FIG. 18E shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with an embodiment of the inventive tissue retractor
implanted with the retractor on an inner surface of palatoglossal
fold and a modified dental anchor;
[0164] FIG. 18F shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with an embodiment of the inventive tissue retractor
implanted with the retractor at the posterior tonsillar fold and
the anchor at the anterior tonsillar fold;
[0165] FIG. 19A is a top view of an embodiment of the inventive
tissue retractor implanted with the anchor at the superior
pharyngeal side of the soft palate and the retractor at the
inferior oral side of the soft palate;
[0166] FIG. 19B is a side view of the embodiment shown in FIG.
19A;
[0167] FIG. 19C is a top view of an embodiment of the inventive
tissue retractor implanted with the retractor at the superior oral
side of the soft palate and the retractor at the inferior
pharyngeal side of the soft palate;
[0168] FIG. 19D is a side view of the embodiment shown in FIG.
19C;
[0169] FIG. 19E is a top view of an embodiment of the inventive
tissue retractor implanted with the anchor at the superior
pharyngeal side of the soft palate, the retractor at the inferior
oral side of the soft palate, and an added bolster engaging the
anchor;
[0170] FIG. 19F is a side view of the embodiment shown in FIG.
19E;
[0171] FIG. 19G is a top view of an embodiment of the inventive
tissue retractor fully implanted in the soft palate;
[0172] FIG. 19H is a side view of the embodiment shown in FIG.
19G;
[0173] FIG. 19I is a top view of an embodiment of the inventive
tissue retractor implanted through the soft palate with the anchor
opposite the retractor;
[0174] FIG. 19J is a side view of the embodiment shown in FIG.
19I;
[0175] FIG. 19K is a top view of the embodiment of the inventive
tissue retractor shown in FIG. 19I and including retainers that
lift edge of soft palate;
[0176] FIG. 19L is a side view of the embodiment shown in FIG.
19K;
[0177] FIG. 20A shows a side cross-sectional view of a horse's
airway during exercise;
[0178] FIG. 20B shows a side cross-sectional view of dorsal
displacement of the soft palate of a horse;
[0179] FIG. 20C shows a side cross-sectional view of an embodiment
of the inventive tissue retractor implanted through the mandible of
the horse to an adjustable anchor in front of the mandible;
[0180] FIG. 20D shows a side cross-sectional view of an embodiment
of the inventive tissue retractor implanted in a horse with the
shaft connecting to an anchor on the tongue surface of the horse
which is reversibly attached to the bit of a bridle during
exercise;
[0181] FIG. 20E shows a side cross-sectional view of an embodiment
of the inventive tissue retractor implanted in a horse with an
anchor in front of the soft palate of the horse and a shaft passing
backward and then through the epiglottis to a retractor on the
laryngeal surface of the epiglottis;
[0182] FIG. 20F shows a side cross-sectional view of an embodiment
of the inventive tissue retractor implanted in a horse with the
shaft passing from the PGFs to the lateral aspect of the soft
palate;
[0183] FIG. 20G shows a front view of the tongue of the horse with
the embodiments of the inventive tissue retractors shown in FIGS.
20E and 20F;
[0184] FIG. 21A shows a side view of airway obstruction due to
backward collapse of the tongue;
[0185] FIG. 21B shows a side view of a non-invasive embodiment of
the inventive tissue retractor with a soft "hook" retracting the
PGF forward and thereby retracting the base of tongue, soft palate
and pharyngeal walls;
[0186] FIG. 21C shows a side view the soft "hook" shown in FIG.
21B;
[0187] FIG. 21D shows a side view of a non-invasive embodiment of
the inventive tissue retractor with a clip compressing the soft
tissue;
[0188] FIG. 21E shows a side view of a non-invasive embodiment of
the inventive tissue retractor with a clip where compression of the
soft tissue is provided by opposing magnets;
[0189] FIG. 21F shows a side view of the non-invasive embodiment of
the inventive tissue retractor shown in FIG. 21E where the magnets
are coupled to a modified anchor;
[0190] FIG. 21G shows a top view of a non-invasive embodiment of
the inventive tissue retractor with having two hook retractors;
[0191] FIG. 21H shows a top view of the hook of the non-invasive
embodiment of the inventive tissue retractor shown in FIG. 21G;
[0192] FIG. 22A shows a side view of a non-invasive embodiment of
the inventive tissue retractor in the form of a clip placed on a
soft tissue fold;
[0193] FIG. 22B shows a top view of the non-invasive embodiment of
the inventive tissue retractor shown in FIG. 22A;
[0194] FIG. 22C shows a front view of the non-invasive embodiment
of the inventive tissue retractor shown in FIG. 22A;
[0195] FIG. 22D shows a front view of a non-invasive embodiment of
the inventive tissue retractor having two clips;
[0196] FIG. 22E shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with an non-invasive embodiment of the inventive tissue
retractor with a clip on the anterior tonsillar pillar attached to
a dental anchor;
[0197] FIG. 22F shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with an non-invasive embodiment of the inventive tissue
retractor with a clip on the posterior tonsillar pillar attached to
a dental anchor;
[0198] FIG. 22G shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with a non-invasive embodiment of the inventive tissue
retractor with a clip on the edge of soft palate attached to a
dental anchor;
[0199] FIG. 22H shows a view of the left lateral pharyngeal wall
area after mid-sagittal section with the tongue retracted
inferiorly with an non-invasive embodiment of the inventive tissue
retractor with two clips retracting the pharyngeal wall toward the
aryepiglottic fold;
[0200] FIG. 23A is a side cross-sectional view of the mouth and
upper airway;
[0201] FIG. 23B is a front view of the mouth and upper airway;
[0202] FIG. 23C is a top view of the mouth and upper airway;
[0203] FIG. 23D is a side cross-sectional view of an embodiment of
the inventive tissue retractor with a bolster pushed downward and
slightly anterior by a protractor from a dental anchor (not
shown);
[0204] FIG. 23E is a front view of the embodiment of the inventive
tissue retractor shown in FIG. 23D;
[0205] FIG. 23F is a top view of the embodiment of the inventive
tissue retractor shown in FIG. 23D;
[0206] FIG. 23G is a side cross-sectional view of an embodiment of
the inventive tissue retractor comprising a bolster;
[0207] FIG. 23H is a front view of the embodiment of the inventive
tissue retractor shown in FIG. 23G;
[0208] FIG. 23I is a top view of the embodiment of the inventive
tissue retractor shown in FIG. 23G;
[0209] FIG. 23J is a side view of an inventive embodiment of a
vacuum device applied to the lateral tongue; and
[0210] FIG. 23K is a side view of the inventive embodiment shown in
FIG. 23K with a vacuum applied to the lateral tongue.
[0211] It is to be understood that the attached drawings are for
purposes of illustrating the concepts of the invention.
DETAILED DESCRIPTION OF THE DRAWINGS
[0212] FIG. 1. Drawing of the human upper airway in the mid
saggital plane.
[0213] NC, Nasal Cavity
[0214] SP, Soft Palate
[0215] PH, Pharynx
[0216] ES, Esophagus
[0217] P, Hard Palate
[0218] MD, Mandible
[0219] T, Tongue
[0220] LR, Larynx
[0221] TR, Trachea
[0222] FIG. 2. Simplified schematic drawing of the tongue and
surrounding structures
[0223] NP, Nasopharynx
[0224] VP, Velopharynx
[0225] HP, Hypopharynx
[0226] SP, Soft palate
[0227] P, Hard palate
[0228] T, Tongue
[0229] GG, Genioglossus muscle
[0230] OP, Oropharynx
[0231] RG, retroglossal space
Areas of the pharynx: Nasopharynx spans from the level of the hard
palate up. Velopharynx spans from the beginning of the end of the
soft palate. Oropharynx spans from the edge of the soft palate to
the epiglottis. Hypopharynx spans from the epiglottis to the
esophagus. The velopharyngeal space (VP) is the area between the
soft palate and back wall of the pharynx. The retroglossal space
(RG) is the area between the tongue base and back wall of the
pharynx.
[0232] FIG. 3. Anatomical landmarks of the tongue. The tongue will
be defined as the grey area of this schematic. From front to back
the tongue is divided into a blade, body, and base. The
genioglossus muscle (GG) inserts into a connective tissue boundary
on the undersurface of the tongue (Bo). The entire region of the
genioglossus muscle and its mucosa is referred to as the "frenulum
area".
[0233] BA) Tongue base
[0234] BD) Tongue body
[0235] BL) Tongue blade
[0236] Bo) Boundary between tongue and genioglossus
[0237] C) Tongue curve
[0238] F) Frenulum
[0239] GG) Genioglossus muscle
[0240] FIGS. 4A-4F--Mechanism of airway obstruction and the effect
of current therapies.
[0241] A) Normal tone in tongue while awake. Tongue remains in
position allowing airway to remain open. Blue arrow 410 shows
airflow, small black arrow 412 shows the relationship of pharyngeal
wall (red line 414) to mandible.
[0242] B) Apnea. During sleep muscle tone is lost in the tongue and
it becomes flaccid. Negative pressure in the pharynx during
inspiration causes backward collapse of the tongue in the
velopharyngeal area because the airway is narrowest at that point
and the tongue curve (circle) is most deformable.
[0243] C) Apnea. After the airway obstructs at the velopharyngeal
area inspiration lowers the pressure in the pharynx further causing
the base of tongue to deform and firmly block the airway.
[0244] D) CPAP works by pumping air at high pressure through the
nose (thick blue line 416), thereby splinting the pharynx open.
[0245] E) Dental devices work by moving the entire jaw forward. As
the tongue is attached to the soft tissues along the floor of the
mouth, and they attach to the jaw, the tongue is indirectly moved
to expand the airway. Note that the jaw has moved in relation to
the pharyngeal wall (arrow).
[0246] F) The LTR prevents posterior deformation of the tongue
curve by directly restraining the tongue curve from moving
backwards.
[0247] FIGS. 5A-5D--Embodiment of the LTR device. Shown is one
embodiment of the LTR.
[0248] A. The LTR has three main components: a retractor (R), shaft
(S), and anchor (A).
[0249] B. Side view of the LTR inserted in a tongue.
[0250] C. Back view of tongue curve showing retractor position.
[0251] D. Back view of tongue base showing the curved midline
shape.
[0252] FIGS. 6A-6H--Retractor member. This figure illustrates a
retractor component of an LTR that can be mounted on a needle for
implantation within upper airway tissue and deploys when the needle
is withdrawn. The retractor is shown as an integral component of
the shaft and is molded as one piece from soft elastomeric
material.
[0253] A-D. Side and front views of the retractor head. The plane
of the retractor rests at about 15.degree. relative to the
shaft.
[0254] E. Side view of retractor head mounted within a needle. A
part of the retractor lays on the outer surface of the needle.
[0255] F. Side view of needle passing through tissue. Note that the
retractor extension lays flat against the needle barrel and does
not interfere with passage of the needle through tissue.
[0256] G. After the needle penetrates mucosa enough to clear the
retractor extension it again extends away from the shaft.
[0257] H. Slight traction on the shaft causes the retractor to
catch the mucosa and come to rest in its working position.
[0258] FIGS. 7A-7C--Shaft member. Shown is an improvement to the
shaft of an LTR that maintains its retractor tension when the
tongue is relaxed, such as during sleep. However, during speech and
swallowing, when the tongue base often moves backward, the activity
of the tongue squeezes the shaft and thereby lengthens it. In this
way there is little or no resistance to the normal tongue
movements.
[0259] A. Schematic view of LTR in the tongue with normal muscle
tone. Note that the retractor lays on the mucosal surface of the
tongue base without indenting it.
[0260] B. During sleep the tongue loses all tone and tends to flop
backward into the airway. The retractor then resists this
deformation.
[0261] C. During swallowing and speech the tongue base sometimes
moves backward. During these movements there is a strong
contraction of the tongue muscles. This contraction squeezes the
upper shaft, this in turn causes the shaft to lengthen and move the
retractor.
[0262] FIGS. 8A-8H--Anchor member, bolster
[0263] A. Front view of bolster.
[0264] B. Top view of bolster.
[0265] C. Side view of bolster.
[0266] D. Side view of tongue with unloaded LTR.
[0267] E. Anchor of shaft is pulled forward slotted into cleft on
underside of bolster.
[0268] F. Bolster in position under tongue.
[0269] G. Close up view of LTR anchor sitting in the recess of
bolster.
[0270] H. Top view of tongue with LTR and bolster.
[0271] FIGS. 9A-9E--Anchor member, dental
[0272] A. A modified anchor that is implanted on the upper or lower
front teeth. The anchor (A) interfaces with the teeth, the shaft
(S) connects to retractor/coupler (R/C). The retractor/coupler
either consists of a retractor that interfaces with tissue, or a
coupler component that connects to an implanted retractor, shaft,
or anchor member of an implanted LTR.
[0273] B. Drawing of top view of tongue and mandible with an LTR
implanted from the tongue base to the frenulum. The anchor of the
LTR can be reversibly attached to the R/C component of the dental
anchor.
[0274] C. Another embodiment of a modified anchor for use on the
lateral teeth.
[0275] D. Top view of tongue and mandible with a lateral dental
anchor. The anchor attaches to the molar tooth, the shaft passes
through the pharyngoglossal fold, and the retractor rests against
the posterior surface of the fold.
[0276] E. Palatal prosthesis with some possible coupling extensions
for retraction or protraction: the soft palate, PGF, floor of mouth
and tongue surface.
[0277] FIGS. 10A-10C--Anchor member, frenulum area.
[0278] Within the genioglossus muscle are small tendons upon which
muscle fibers insert at various angles. The main tendon is in the
middle of the muscle and smaller tendons branch off at various
points. Preferably an anchor in the frenulum area (F) is inserted
such that its implanted part passes through a tendon (TD). However
the anchor (A) can be inserted at any spot in the frenulum area or
soft tissue attached to the mandible. The anchor could be coupled
to an LTR by a variety of mechanisms as described herein.
[0279] A. Side view of the tongue and mandible cut in the
centerline (mid-sagittal plane).
[0280] B. Drawing of A.
[0281] C. Close up of the frenulum area.
[0282] FIGS. 11A-11E--Frenulum area embodiment.
[0283] A. Side view of tongue and mandible cut at the centerline.
The frenulum is the front edge of the genioglossus muscle, frenulum
area refers to the entire genioglossus and surrounding mucosa. The
front and rear boundaries of the genioglossus muscle are marked by
solid lines. The genioglossus muscle attaches to a small area on
the inner surface of the mandible and tendinous extensions from
that area. It fans out from these attachments to insert mostly into
connective tissue along the length of the body and base of the
tongue called the boundary layer.
[0284] B. Drawing of A.
[0285] C. Shown is an LTR passing through the frenulum area and
anchored externally to a dental anchor. The implanted part of the
LTR exerts side forces on the genioglossus muscle fascicles and
this is conveyed to the boundary layer and finally to the tongue
base (arrow).
[0286] D. Shown is an LTR passing through the boundary layer and
anchored to a frenulum anchor. Displacement of the tongue is marked
by the arrow.
[0287] E. Shown is a fully implanted LTR in the frenulum area
connecting the boundary area in two places. Note that the
beneficial retraction of the tongue base causes some retraction of
the tongue blade, however, this does not interfere with tongue
function.
[0288] FIGS. 12A-12F--Tongue base implant.
[0289] A. Frontal section of tongue base.
[0290] B. Drawing of A. Light lines are the connective tissue of
the tongue superior layer (SL) and midline septum (MS). ML, middle
layer.
[0291] C. Position of LTR implant connecting SL and ML.
[0292] D. Tongue seen in mid-sagittal plane. Oval marks the area of
mechanical decoupling.
[0293] E. Schematic drawing of the box marked in D.
[0294] F. Position of implant.
[0295] FIGS. 13A-13T Tongue base embodiments
[0296] A and B. Lateral (left) and top (right) drawings of the
tongue with an LTR connected by a shaft passing underneath the
tongue base mucosa. Green ovals 1310 correspond to anchors and
retractors, shaft is dotted yellow when implanted and solid when
outside, black arrows 1312 show direction of traction.
[0297] C and D. An LTR with the shaft taking a more direct route
between retractor and anchor.
[0298] E and F. An LTR with the shaft exiting from mucosa close to
the retractor and anchor.
[0299] G and H. Implanted anchor and retractor with a reversible
attachable shaft.
[0300] I. Lateral view of a partially implantable anchor or
retractor.
[0301] J. Top view of a partially implantable anchor or
retractor.
[0302] K. Partially implantable anchor/retractor showing the shaft
connection.
[0303] L. Lateral view of a partially implantable anchor/retractor
with the extension depressed flush with mucosa when not in use.
[0304] M and N. An LTR with an elastic sleeve placed over the
tongue blade and a shaft connecting to a semi-implanted retractor
member.
[0305] O and P. An LTR anchored at the PGFs and a shaft passing
across the tongue base and connecting to a semi-implanted retractor
member.
[0306] Q and R. An LTR anchored beneath the tongue blade with a
shaft passing through the tongue blade to an intermediate anchor on
the superior surface of the tongue. The shaft then passes
posteriorly to a semi-implanted retractor member. This allows
adjustment of tension from the anchor site beneath the tongue
blade.
[0307] S and T. Left, a rigid shaft connects an anchor member below
the tongue blade to a retractor member above the tongue blade. The
retractor member is rotated forward by a sleeve that is reversibly
placed over the tongue blade. The rotation of the retractor member,
along with the rigid shaft, displaces the tissue of the tongue base
along the midline. Drawing is intentionally exaggerated to show the
effects.
[0308] FIGS. 14A-14E--The Superior Palatoglossal Fold (SPGF).
[0309] A. Side view of the upper airway showing the area of the
tongue (T) where the PGF inserts, i.e., the location of the
pharyngolassal fold insertion (PGFI). A smaller superior region is
of particular significance as it receives overlapping insertions of
muscles connecting to the soft palate (SP) and lateral pharyngeal
walls (PHW), including but not limited to the palatoglossus (PA)
and superior pharyngeal constrictor (SPHC) muscles.
[0310] B. Side view of tongue in relation to mandible with the area
of superior PGF attachment marked.
[0311] C. The palatoglossus muscle is shown connecting the soft
palate to the superior PGF.
[0312] D. The superior pharyngeal constrictor muscle connects the
pharyngeal walls to the superior PGF.
[0313] E. Schematic showing that retraction force of the PGF is
dispersed to the tongue base, soft palate, and lateral pharyngeal
walls.
[0314] FIGS. 15A-15F--Pharyngoglossal Fold embodiments
[0315] A. Drawing showing the posterior collapse of the tongue and
its effects on the airway.
[0316] B. A retractor at the PGF and a shaft that passes across the
frenulum to a retractor in the other PGF.
[0317] C. A retractor in the PGF and a shaft passing through tongue
tissue to emerge and connect to a modified anchor. An alternative
embodiment passes through the floor of mouth to an external anchor
resting on the skin.
[0318] D. An implanted LTR with a retractor in or near the PGF and
a shaft passing through tongue to an anchor implanted in
genioglossus muscle, or floor of mouth structures.
[0319] E. An LTR with a retractor in the superior PGF and an anchor
in the inferior PGF.
[0320] F. A retractor in the PGF and a shaft passing through tongue
to an anchor on the superior surface of the tongue.
[0321] FIGS. 16A-16L--Pharyngoglossal Fold embodiments.
[0322] A and B. Retractor at tongue base connected by two
sub-mucosal shafts to anchors in front of each PGF.
[0323] C and D. A sub-mucosal shaft connect two retractor/anchor
members in front of each PGF.
[0324] E and F. Two implanted retractor/anchor members in or near
the PGFs are connected by a sub-mucosal shaft.
[0325] G and H. Magnets implanted in or near each PGF are connected
by a sub-mucosal shaft.
[0326] I. A magnet implanted in a PGF is retracted by a magnet of
opposite polarity attached to a modified anchor.
[0327] J. A magnet is enclosed in an implant that has two flanges
to keep in place within the PGF.
[0328] K. A schematic of a dental type modified anchor. The anchor
member is a clasp that reversibly attaches to teeth as shown on
right. A shaft of variable length attaches to a retractor member or
a coupling mechanism that in turn connects to an implanted LTR. The
retractor member may be a magnet or mechanical mechanism.
[0329] L. Drawing of tongue and mandible seen from above. Two
embodiments of the dental modified anchor are shown: bottom, the
retractor member is a magnet that couples to an implanted magnet as
shown in E left; top, the shaft ends with a magnet that couples to
a reversible magnetic implant as shown in E, right.
[0330] FIGS. 17A-17C--Soft Palate embodiments.
[0331] A. View of the mouth showing the soft palate (SP), the
palatopharyngeus fold (PAPHF) and palatoglossal folds (PAF) (Henry
Gray. Anatomy of the Human Body. 1918).
[0332] B. Same view as A but with mucosa removed showing the
underlying muscles (right side) and the nerve and blood supply
(left side).
[0333] C. View of the left lateral pharyngeal wall area after
mid-sagittal section. Tongue is retracted inferiorly.
[0334] Four preferred LTR placements are shown with an anchor in
the superior PGF: 1) Shaft passes next to palatoglossus muscle
(PAM) around tonsil (TN), retractor rests against lateral edge of
soft palate. Preferred embodiment for increasing lateral
velopharyngeal area. 2) Shaft travels within palatoglossus muscle,
retractor near midline soft palate. Preferred embodiment for
increasing medial velopharyngeal airspace; 3) Shaft passes through
palatoglossus muscle, palatine tonsil, and palatopharyngeus muscle
(PAPHM), retractor rests against posterior wall of soft palate.
Preferred embodiment for compression and permanent remodeling of
palatine tonsil. 4) Shaft passes 1 cm under tongue base mucosa,
retractor rests against tongue base. Preferred embodiment for
tensing tongue base.
[0335] FIGS. 18A-18F--Tonsillar Fold embodiments
[0336] 18A. Retractor posterior surface of posterior tonsillar
fold, anchor anterior surface of anterior tonsillar fold. Preferred
embodiment for compression of palatine tonsil.
[0337] 18B. Retractor superior Palatoglossus fold, retractor
inferior Palatoglossus Fold or PGF.
[0338] 18C. Implanted LTR within palatoglossus muscle.
[0339] 18D. Anchor at lateral aspect of soft palate, retractor
midline.
[0340] 18E. Retractor on inner surface of palatoglossal fold,
modified dental anchor.
[0341] 18F. Retractor at posterior tonsillar fold and anchor at
anterior tonsillar fold.
[0342] FIGS. 19A-19L--Soft palate embodiments
[0343] A and B. Anchor superior pharyngeal side, retractor inferior
oral side.
[0344] C and D. Retractor superior oral side, anchor inferior
pharyngeal side.
[0345] E and F. Bolster added in front of anchor to load the LTR.
Note indentation and rotation.
[0346] G and H. Totally implanted LTR.
[0347] I and J. Opposing retractor and anchor.
[0348] K and L. LTR as attachment for retainers that lift edge of
soft palate.
[0349] FIGS. 20A-20G--Veterinarian embodiments
Shown are embodiments of this invention for equine dorsal
displacement of the soft palate.
[0350] A. Normal configuration of the horse upper airway during
exercise. Note that the soft palate overlaps and interlocks the
epiglottis of the larynx to provide an open conduit for airflow
(blue line 2010).
[0351] B. In DDSP the soft palate is dislodged from its locked
position and obstructs the airway. This is believed to be caused by
the backward movement of the tongue base.
[0352] C. An embodiment of an LTR for this condition. The shaft
reaches through the mandible to an adjustable anchor in front of
the mandible.
[0353] D. Another embodiment where the shaft connects to an anchor
on the tongue surface which is reversibly attached to the bit of a
bridle during exercise.
[0354] E. An embodiment that directly opposes dislodging the soft
palate from its normal position. An anchor in front of the soft
palate passes backward and then through the epiglottis to a
retractor on the laryngeal surface of the epiglottis.
[0355] F and G. In an alternative embodiment an LTR passes from the
PGFs to the lateral aspect of the soft palate. View is from the
front, tongue is transparent. For comparison the midline embodiment
described in E is also shown.
[0356] FIGS. 21A-21H--Non-invasive PGF retractor
[0357] A. Schematic of airway obstruction due to backward collapse
of the tongue.
[0358] B. PGF retraction. Soft "hook" retract the PGF forward and
thereby retracts the base of tongue, soft palate and pharyngeal
walls.
[0359] C. Close up view of "hook".
[0360] D. Close up view of "clip". Clip remains in place by
compressing soft tissue by its arms.
[0361] E. An embodiment of the clip where compression is performed
by magnets.
[0362] F. Embodiment from E where the magnets are also used to
couple the retractor to a modified anchor.
[0363] G. Drawing of two hook retractors in place and their effect
on the tongue base (dotted line).
[0364] H. Close-up view of hook LTR.
[0365] FIGS. 22A-22H Non-invasive retraction, clip embodiment.
[0366] A. Side view of clip on soft tissue fold. One method of
adhering to the fold is to compress the tissue at the ends of the
clip.
[0367] B. Side view of clip composed of opposing magnets of
opposite polarity. Their magnet attraction provides sufficient
force for a stable position and a shaft is unnecessary.
[0368] C. Front view of clip on a soft tissue fold. The shaft
connection can serve to retract the edge of the fold.
[0369] D. Clips used to provide protraction (lengthening, a useful
effect on structures that benefit from stiffening such as the soft
palate and tongue base.
[0370] E. Clip on anterior tonsillar pillar attached to a dental
anchor.
[0371] F. Clip on posterior tonsillar pillar attached to a dental
anchor.
[0372] G. Clip on edge of soft palate attached to a dental
anchor.
[0373] H. Two clips retracting the pharyngeal wall toward the
aryepiglottic fold, thus stiffening the lateral pharyngeal
wall.
[0374] FIGS. 23A-23K Non-invasive protraction and vacuum. Floor of
mouth depression.
[0375] A. Side view. Floor of mouth is marked by a checkered
pattern that extends from the mandible to the hyoid bone.
[0376] B. Front view. Floor of mouth connects to the bottom of each
side of the mandible.
[0377] C. Top view. Tongue is transparent and triangular root of
tongue can be seen. The anterior extension of the root is the
genioglossus muscle insertion into the mandible.
[0378] D. Bolster pushed downward and slightly anterior by a
protractor from a dental anchor (not shown). Note the indentation
of the FOM and the altered position of the tongue and PGF.
[0379] E. FOM depression by bolster reflected by decreased height
of tongue surface.
[0380] F. Bolster seen from above. Note anterior displacement of
base of tongue.
[0381] G. Bolster pushed anteriorly.
[0382] H. FOM depression by bolster.
[0383] I. Bolster seen from above. Note anterior displacement of
base of tongue.
[0384] J. A vacuum device applied to the lateral tongue.
[0385] K. A vacuum device as a retractor member.
DETAILED DESCRIPTION
[0386] The term "subject" as used herein includes animals of
mammalian origin, including humans. Anatomical terminology used to
describe position and orientation as used herein can best be
defined by the following description:
[0387] When referring to animals that typically have one end with a
head and mouth, with the opposite end often having the anus and
tail, the head end is referred to as the cranial end, while the
tail end is referred to as the caudal end. Within the head itself,
rostral refers to the direction toward the end of the nose, and
caudal is used to refer to the tail direction. The surface or side
of an animal's body that is normally oriented upwards, away from
the pull of gravity, is the dorsal side; the opposite side,
typically the one closest to the ground when walking on all legs,
swimming or flying, is the ventral side. On the limbs or other
appendages, a point closer to the main body is "proximal"; a point
farther away is "distal". Three basic reference planes are used in
zoological anatomy. A "sagittal" plane divides the body into left
and right portions. The "mid-sagittal" plane is in the midline,
i.e. it would pass through midline structures such as the spine,
and all other sagittal planes are parallel to it. A "coronal" plane
divides the body into dorsal and ventral portions. A "transverse"
plane divides the body into cranial and caudal portions.
[0388] When referring to humans, the body and its parts are always
described using the assumption that the body is standing upright.
Portions of the body which are closer to the head end are
"superior" (corresponding to cranial in animals), while those
farther away are "inferior" (corresponding to caudal in animals).
Objects near the front of the body are referred to as "anterior"
(corresponding to ventral in animals); those near the rear of the
body are referred to as "posterior" (corresponding to dorsal in
animals). A transverse, axial, or horizontal plane is an X-Y plane,
parallel to the ground, which separates the superior/head from the
inferior/feet. A coronal or frontal plane is an Y-Z plane,
perpendicular to the ground, which separates the anterior from the
posterior. A sagittal plane is an X-Z plane, perpendicular to the
ground and to the coronal plane, which separates left from right.
The mid-sagittal plane is the specific sagittal plane that is
exactly in the middle of the body.
[0389] Structures near the midline are called medial and those near
the sides of animals are called lateral. Therefore, medial
structures are closer to the mid-sagittal plane, lateral structures
are further from the mid-sagittal plane. Structures in the midline
of the body are median. For example, the tip of a human subject's
nose is in the median line.
[0390] Ipsilateral means on the same side, contralateral means on
the other side and bilateral means on both sides. Structures that
are close to the center of the body are proximal or central, while
ones more distant are distal or peripheral. For example, the hands
are at the distal end of the arms, while the shoulders are at the
proximal ends.
Definitions
[0391] "Anchor" refers to a component of the device that
mechanically couples to a site that is immobile relative to the
retractor.
[0392] "Deformation" refers to an abnormal change in the shape of
upper airway soft tissue structures. This deformation can be due to
negative pressure acting on relaxed upper airway structures during
sleep causing them to narrow the upper airway. Most preferably this
soft tissue can be the tongue curve.
[0393] "Frenulum" refers to the vertical anterior edge of the
genioglossus muscle. The frenulum passes from the floor of the
mouth up to the centerline of the underside of the tongue. The
frenulum marks the boundary between the tongue blade and tongue
body.
[0394] "Frenulum area" refers to the genioglossus muscle and its
surrounding mucosa.
[0395] "Loaded" refers to an LTR that can have its tension adjusted
such that it has minimal tension during the day and higher
therapeutic levels of tension at night. The loaded configuration
corresponds to the higher therapeutic levels.
[0396] "Modified anchor" is an additional component that allows
attachment of the permanent anchor of the LTR. In some embodiments
the modified anchor allows the patient to adjust tension in the
LTR, specifically to increase tension at night and release it
during the day.
[0397] "Palate retractor" refers to a complete device used for the
prevention soft palate deformation.
[0398] "Permanent anchor" refers to an anchor component of an LTR
that remains on the LTR for the duration of the implantation. The
permanent anchor prevents the anterior end of the shaft from
slipping back into tongue tissue. In certain embodiments the
permanent anchor also serves as a part of a connector when a
"modified anchor" is used.
[0399] "Pharyngeal wall retractor" refers to a complete device for
the prevention of pharyngeal wall deformation.
[0400] "Protract" means to lengthen or push apart.
[0401] "Reverse deformation" refers to a change in soft tissue
shape caused by the tissue retractor. In some embodiments reverse
deformation refers to restoring a deformed structure to its normal
shape. In other embodiments reverse deformation refers to an
indentation of soft tissue in a given area due to the action of a
tissue retractor.
[0402] "Sleep breathing disorders" refers to all breathing
disorders occurring during sleep including but not limited to
obstructive sleep apnea, obstructive sleep apnea syndrome, upper
airway resistance syndrome, and snoring.
[0403] "Tongue base" refers to the part of the tongue posterior to
the tongue curve. In anatomical terms the line of demarcation of
the tongue base is the circumvallate papillae, a grossly visible
line of raised taste organs on the superior surface of the
tongue.
[0404] "Tongue blade" refers to the part of the tongue anterior to
the frenulum. It is covered by mucosa on its top, sides and
undersurface.
[0405] "Tongue body" is the mid part of the tongue located between
the tongue blade and tongue base.
[0406] "Tongue boundary" or "boundary" is the inferior surface of
the tongue body and base. The genioglossus muscle inserts onto a
large part of the boundary.
[0407] "Tongue curve" refers to the area of the tongue where its
superior surface curves from a horizontal orientation (tongue body
and blade) to a vertical orientation (tongue base). Preferably
tongue curve refers to the soft tissue in this area between the
mucosal covering of the tongue and the connective tissue boundary
where the genioglossus muscle attaches.
[0408] "Tissue retractor" refers to the complete device of
embodiments of the invention for the prevention of soft tissue
deformation. The device may be used without limitation in the
tongue, soft palate, or pharyngeal walls.
[0409] "Tongue retractor" refers to a complete device used for the
prevention of tongue deformation. Preferentially it comprises a
retractor connected to a shaft which in turn is connected to an
anchor.
[0410] "Laryngeal retractor" refers to a complete device for the
prevention of laryngeal soft tissue deformation.
[0411] "Retractor" or "retractor head" or "retractor member" refers
to a part of the overall tissue retractor. The retractor physically
interacts with soft tissue, either directly or indirectly, to
prevent it from deforming. In certain embodiments the retractor
head is a disc located on the external surface of the tongue, in
other embodiments the retractor head is an inflatable balloon, in
other embodiments the retractor head may have curved parts that act
like hooks, in other embodiments the retractor head may be a
flexible wire passing through the tissue. In some embodiments it
may be totally implanted within tissue.
[0412] "Retractor shaft", "shaft" or "retractor member" refers to
that part of the tongue retractor that attaches to the retractor
head and serves to connect it to the retractor anchor. In different
embodiments the shaft may be rigid or flexible, solid or hollow,
one piece or multiple linked pieces.
[0413] "Unloaded" refers to an LTR that exerts little or no
tension. As used herein this is usually meant as the configuration
during the day. In comparison, the LTR is loaded to therapeutic
levels at night.
EXAMPLES
1. Retractor Member (FIGS. 6A-6H)
[0414] Disclosed here is a retractor member that is inserted by a
needle and automatically deploys to its working shape.
[0415] The retractor head prevents the tongue base from deforming.
The preferred qualities for a retractor head that rests upon tongue
base mucosa are that its depth is minimal so that it is not
noticeable to the patient yet its surface area is large enough to
provide sufficient counterforce. Integral to its design is the
delivery device used to insert the LTR. It is preferable that the
entire device be inserted from the anterior tongue with minimal
instrumentation used at the back of the tongue. Therefore the
retractor head preferably automatically deploys to its working
shape after being implanted by a needle inserted from the front of
the tongue.
[0416] Part of this aspect of the invention includes improvements
in the design of the retractor head that allow it to be easily
inserted. In certain embodiments this insertion would be by a
needle. Therefore one embodiment of this invention is a retractor
head that folds within a needle but deploys to its working shape
after insertion. Many mechanisms are known that allow a device to
be minimized for insertion in the body, non-limiting examples
include nitinol wire, high pressure balloons, and spring
mechanisms. These mechanisms work well but add complexity and
unnecessary expense.
[0417] In a preferred embodiment the retractor component is oval
shaped (10 mm long, 5 mm wide, 2.5 mm deep) and is molded together
with the shaft (1 mm) as a single piece from moderate consistency
medical grade silicon (Shore 80 durometer, Nusil, Ca) (FIGS.
6A-6D). The retractor is tilted 75.degree. in relation to the
shaft. When the device is threaded into a needle (6E) one side of
the oval extends out of the needle port and projects at a
15.degree. angle relative to the outside wall of the needle. When
the needle is inserted through tissue this extension is pushed
flush against the needle wall and causes a minimum increase in the
needle's profile (6F). However, immediately after the needle passes
through mucosa the retractor reverts to its extended position (6D).
In this manner pulling back the needle causes the retractor to
catch mucosa and prevents it from being withdrawn along with the
needle. After the needle is removed, minor tension on the shaft
causes the retractor head to rotate into proper position and lay
flush against the mucosa (6G).
[0418] The practical advantages of this invention is that the
physician can rapidly and easily insert and withdraw the needle and
the device automatically settles into its proper position.
2. Shaft Member. (FIGS. 7A-7C)
[0419] Disclosed here is a modified shaft that adapts its length to
avoid interfering with normal movements of the tongue base.
[0420] The counterforce exerted against the back of the tongue base
is preferably present during sleep but not during the awake state.
More preferably, the counterforce is present when the tongue is
relaxed and vulnerable to posterior collapse, but not during speech
and swallowing. During swallowing the tongue base moves rapidly
backward about 1 cm to contact the back wall of the pharynx. The
tongue base moves similarly during some speech movements, albeit
with much less force. It is desirable that these swallowing and
speech movements are not impaired.
[0421] In one embodiment of the shaft the section within the tongue
is distensible, one non-limiting example being a balloon.
Compression of the balloon portion of the shaft allows the shaft to
lengthen. During swallowing the tongue contracts forcefully around
the shaft. This contraction squeezes the balloon and lengthens it,
thereby displacing the retractor head superiorly. As the tongue
base moves superiorly in the area of the retractor head during
swallowing, the compression exerted on the shaft causes the shaft
to lengthen proportionally and prevents the retractor head from
exerting unneeded counterforce on the tongue base during
swallowing. However, the ability to exert the proper amount of
counterforce when the tongue is relaxed is maintained. The amount
of distensibility is preferably 0.01 to 10 cm, more preferably 1
cm.
[0422] This embodiment is a preferred but non-limiting example of
the invention. The decrease of counterforce by the retractor head
during swallowing and speech can be accomplished by many mechanical
and electromechanical mechanisms known. Those skilled in the art
can readily appreciate that the invention can have multiple
embodiments.
3. Anchor Member: Bolster, Dental, Implanted (FIGS. 8A-8H, 9A-9E,
and 10A-10C)
[0423] Disclosed here are modified anchors that allow reversible
loading of an implanted LTR.
[0424] The anchor is the anterior component of the LTR that resists
displacement of the shaft and retractor head. In a preferred
embodiment the LTR is under little or no tension during the day
(unloaded state) and is adjusted to exert tension at night (loaded
state). In this embodiment the anchor merely prevents the anterior
end of the shaft from being pulled back into tongue tissue. For
this purpose a small flange is sufficient. However, at night when
further retractor counterforce is desired, the anchor can be
replaced, modified, or supplemented; collectively referred to as a
modified anchor.
[0425] One embodiment of a modified anchor may include a removable
adjustment member, for example, a bolster that is interposed
between the permanent anchor and the tongue (FIGS. 8A-8H), such
that, after implantation, the retractor, the permanent anchor, and
the bolster are external to the soft tissue and the flexible shaft
maintains a tension between the retractor member and the anchor
member to impart a force on the soft tissue. This bolster either
lengthens the shaft, or if the shaft is set at a fixed length it
increases the total volume compressed between the retractor head
and shaft. In either case, the addition of the bolster of the
modified anchor causes a reversible increase in retractor
counterforce, i.e., the bolster adjusts the tension between the
retractor member and the anchor. The removable adjustment member
may also change the surface area of the anchor member as shown in
FIGS. 8A-8H.
[0426] In one embodiment of the modified anchor the bolster is
composed of silicon gel shaped as a V (FIGS. 8.A, B, and C). The
concave inner surface of the `V` adapts to the wedge shape of the
frenulum, the structure underneath the tongue blade. The intent is
to spread the retracting counterforce across a wide surface area.
In the center of the anchor bolster is a conduit through which the
permanent anchor and shaft is threaded. In one embodiment there is
a cleft beginning in the center of the top center edge. This cleft
is about the width of the shaft but less than that of the permanent
anchor. The patient can reach under the tongue and pull the
permanent anchor forward (FIGS. 8.D, E, and F), slip the bolster
under the tongue, lay the shaft into the cleft, and release the
permanent anchor. The permanent anchor then securely rests against
the front surface of the cleft and exerts force. The cleft may be
reinforced with a harder grade of silicon or another biocompatible
material.
[0427] Another embodiment of this invention is to secure the
permanent anchor to a modified bolster that is permanently or
reversibly attached to the teeth, a dental anchor (FIGS. 9A-9E).
Many devices that attach to teeth are known in the art. A
non-limiting example is 2T' shaped; the top cross bar of the T
rests against the front surface of the lower incisor teeth. The
initial section of the vertical line of the T is thin enough to
pass between the front two incisor teeth. This vertical part widens
to allow the retractor head to be threaded. The final part of the T
narrows again to about the width of the shaft. This mechanism
allows the anchor to be easily and reversibly attached to the
dental bolster (FIGS. 9.A and B).
[0428] Another embodiment is a dental anchor optimized for use on
the sides of the mouth rather than the front. This embodiment
(FIGS. 9.C, D) anchors to a molar or premolar tooth or neighboring
structures. This embodiment is advantageous due to the short
distance between the LTR and the modified anchor, its position on
the lateral aspect of the tongue is unlikely to interfere with
normal tongue function, and it is easily accessible for placement,
adjustment and removal by patient and physician.
[0429] In a further embodiment a dental prosthesis is used as an
anchor that couples to LTRs in the soft palate, palatoglossal
folds, pharyngoglossal folds, tongue, or other upper airway sites
(FIG. 9.E). These prostheses are well known in the dental arts, and
provide a wide and stable platform for anchoring embodiments of the
LTR. Further embodiments can take advantage of the large size and
position of these prostheses. Those skilled in the art can
understand that a variety of electrical or mechanical mechanisms
could be incorporated within these prosthesis. As a non-limiting
example, an electrical motor could be used to control the force
applied to coupled LTRs at multiple locations in the upper
airway.
[0430] Still another embodiment of the modified anchor is partially
implanted into the floor of the mouth. In one embodiment of this
invention a puncture is made across the frenulum or soft tissue
structures of the floor of the mouth. A flexible shaft is threaded
through the puncture and the ends connected to make a ring like
structure. This modified anchor therefore is securely fixed within
tissue while the remainder lies along the floor of the mouth (FIGS.
10A-10C). The modified anchor then can be reversibly attached to
the permanent anchor at night and disengaged in the morning.
4. Frenulum Area Embodiments
[0431] Disclosed are methods and devices for retracting or
preventing deformation of the tongue base by retracting the
genioglossus muscle or the boundary fascia upon which genioglossus
muscle inserts (collectively referred to as the frenulum area).
[0432] It has been unexpectedly found that the shaft of the LTR can
be safely passed across the undersurface of the tongue. This tissue
contains the genioglossus muscle and its anterior edge is the
frenulum (FIG. 11.A, B). The genioglossus muscle originates from
the mandible and has multiple separate muscle fascicles that fan
out from a horizontal to vertical angle. The genioglossus fascicles
attach to a layer of connective tissue within the tongue called the
boundary (FIG. 11.A, dotted line). The genioglossus fascicles
normally act by exerting force in the axis of the fascicle onto the
part of the boundary to which they are attached. However, even when
inactive the fascicles are mechanically coupled to the tongue
boundary and can exert force if passively moved. Unexpectedly, this
can be done by pulling these fascicles perpendicular to their axis
(FIG. 11.C). To simplify the mechanism, the genioglossus fascicles
are lassoed by the LTR shaft.
[0433] There are certain important considerations in placing a
retractor through the genioglossus: First, the genioglossus is soft
in comparison to the tongue base, therefore too much force applied
in a localized area can tear the tissue or cause undesirable tissue
remodeling over time, sometimes called the "cheese cutter effect".
However, there is a central tendon to the genioglossus that is very
strong. This tendon is located approximately 1 cm from the edge of
the frenulum. Second, the nerve supply to the genioglossus passes
along the superior aspect of the muscle, therefore the top 0.5 cm
of the muscle, the area directly below the tongue blade, is not a
preferable site for the implant.
[0434] In one embodiment the shaft is a 5 cm length of elastomeric
material that is ribbon shaped. The cross sectional dimensions are
0.5 mm depth and 3 mm width. The wider dimension of the ribbon will
exert force on the tissue as its force is dispersed over a wider
area than the narrow edge of the ribbon. The shaft is attached to a
needle and passed through the muscle approximately 1 cm behind the
frenulum. The ends of the shaft are then reversibly coupled to a
modified anchor. The middle section of the shaft itself exerts
anterior retracting force onto the genioglossus muscle and acts as
a retracting head: one or both ends of the shaft can then be
brought forward and secured to a modified anchor. This displacement
is transmitted to the tongue base causing some degree of concavity.
The passive movement is preferably in an anterior and inferior
direction.
[0435] The advantages of genioglossus muscle retraction is that
this muscle group is easily accessible beneath the tongue. The
tissue is soft and easily compressed, making it easy to pierce
without complications. The position under the tongue is invisible
to others, a quality important for the patient.
[0436] A further embodiment of this invention is to pass the LTR
deeper into the tongue to couple directly to the boundary layer
(FIG. 11.D). The boundary layer is a relatively firm connective
tissue structure which spans the length of the body of the tongue
and receives the insertion of the genioglossus muscle. The
advantages of coupling to the boundary layer are that it provides a
more secure attachment then the genioglossus itself. However,
greater care is needed for placement of the device. Specifically
the lingual arteries course just superior and lateral to the
boundary layer so it is essential that the insertion be made medial
to this structure.
[0437] In a further embodiment a fully implanted LTR connects one
site that effects the tongue base and is anchored at another site
that does not. A non-limiting example is shown in FIG. 11E. Here
the posterior boundary layer is coupled to the anterior boundary
layer. Tension between the two sites displaces the tongue base
forward. Simultaneously there is some displacement force exerted
around the anterior boundary site but this has insignificant
effects on normal tongue function.
5. Implanted Tongue Base Retractor (FIGS. 12A-12F)
[0438] Disclosed here are methods and devices that are implanted
within the tongue and exert highly localized forces to prevent
mechanical decoupling of tongue base structures.
[0439] Chronic implants within the tongue are technically
challenging and potentially dangerous. The tongue is a mobile
structure and tongue movements during swallowing and speech are
dependent on this mobility. The tongue has no bones within it and
its mechanism of movement is unique among the muscular structures
of the body. Most skeletal muscles are attached to bones and
movement occurs as mechanical levers. In the tongue structures
cause movement by expanding and changing their shape and volume.
The mechanism is called a muscular hydrostat and can be likened to
a flexible hydraulic system. In addition the tongue has extensive
nerve and blood supply that can be easily damaged. Moreover, the
tongue has a tremendous ability to remodel itself when effected by
implants and other forces. This is why many prior art devices have
failed due to gradual loss of tension or extrusion. Moreover any
implant is a potential site for infection and scarring. For these
reasons any invasive intervention in the tongue must be designed
with a detailed knowledge of tongue anatomy and physiology.
[0440] Therefore the implanted embodiments disclosed in this
invention are carefully designed to be as minimally invasive as
possible and to focus their effects on the most critical areas of
pathology without risking interference with normal function.
[0441] A preferred embodiment of an implanted LTR disclosed here is
a very minimal device implanted into the tongue base.
[0442] The tongue is covered by mucosa and this mucosa has
underlying connective tissue. The connective tissue is thickest
below the superior surface of the tongue. This superior surface is
intimately connected to the underlying superior longitudinal
muscle. Together the mucosa connective tissue and muscle form a
superior layer (SL) that spans the superior surface of the tongue
from the tongue tip to its base. This superior layer is normally
coupled to the underlying middle layer of the tongue which is
largely composed by the transverse muscle. The transverse muscle
originates from a fascial sheet called the medial septum (MS)
oriented in the centerline of the tongue (mid-saggital plane).
[0443] Although not wishing to be bound by theory studies by the
inventor suggest that the vibration during snoring and the
stretching during airway obstruction gradually loosen the
attachment of the superior layer to the middle layer. This is
reflected by the widening of the superior layer in the area of the
tongue curve, marked by an oval. This mechanical decoupling results
in a more flaccid and compliant tongue base that deforms more
easily when the pressure in the airway decreases, thereby making
the patient susceptible to sleep apnea and other sleep breathing
disorders.
[0444] In one embodiment of the invention a very small LTR can be
inserted at the curve of the tongue base to correct the mechanical
decoupling of the tongue layers. The LTR is symmetrical with an
arrowhead shaped retractor head and anchor. Each end of the LTR
mechanically hooks into soft tissue, preferably the connective
tissue fascia of the mucosa and the midline septum. The hooking
mechanism can be quite varied as many variations are known in the
art. Non-limiting examples are: hooks, barbs, helixes, staples,
screws, sutures, biointegrated permanent material, collagen, and
elastin. However, the preferred embodiment is as simple as
possible: a short elastic shaft with a hook of firmer consistency
at either end.
[0445] In alternative embodiments the implanted LTR can vary from 1
mm to 3 cm. Longer LTRs can couple the tongue base tissue to the
boundary fascia between the tongue and genioglossus muscle, through
the boundary layer to the genioglossus muscle, floor of mouth or
mandible via barbs, hooks, fibrotic reaction, or other methods
known in the art. The implant can be composed of biodegradable
material that decomposes in a week to a year. Many materials used
for surgical sutures can be adapted for this purpose.
[0446] Preferably the shaft is oriented such that the force on the
retractor is at least one orientation that includes downward,
forward, and to the side. Multiple implants may be used along the
midline to distribute the coupling force without interfering with
normal function. Depending on the anatomy of the patient implants
may be inserted at any site in the tongue however, more preferable
is the midline of the tongue and most preferable is the midline of
the tongue curve. One or more of the following aspects of the
invention can be used to mold the effects for the exact needs of
the individual patient: implant site and orientation, shaft length
and elasticity, and hook size, shape, and hardness.
[0447] Preferably the implant is bioresorbable over a period of 1
day to 10 years, more preferably 1 month to 1 year, most preferably
1 month to 6 months. The most preferable time range allows
sufficient time for remodeling of the tongue and persistent if not
permanent restoration of mechanical coupling in the area. Permanent
implants are less preferable.
[0448] It is preferable that permanent or resorbable implants be
inserted into superficial levels of the tongue in areas that do not
normally undergo a great amount shape change during normal tongue
activity. This minimizes the possibility of interference with
normal function, particularly if there is an infection or fibrous
reaction to the implant. To plan for atraumatic removal of the
implant in cases of infection, pain or other complication, the
implant should be designed to be easily removed without extensive
surgery. To facilitate removal of the implant, the tear strength of
the hooking mechanism should preferably range from 1 to 1000 grams.
More preferably 10 to 100 grams. Preferably the arms of the hook
would fold straight at these tear strength limits, allowing the
implant to be removed without further damage to tissue as it is
extracted.
6. Tongue Base Retraction (FIGS. 13A-13T)
[0449] Disclosed here is an embodiment of this invention that
focuses on retracting tissue of the tongue base, particularly the
tongue base mucosa. This has the advantage that it is easy to
insert by the physician, minimally invasive and easily adjustable
by the patient.
[0450] In one embodiment the device is inserted from one site to
another on the superior surface of the tongue. The anterior part of
the device is the anchor and the posterior part is the retractor.
Tension between the two retracts the tongue surface and displaces
the tongue base. Although the counter traction affects the anterior
tongue surface it has no effect on normal function.
[0451] The shaft either passes directly underneath the mucosa
(FIGS. 13A, B) or takes a more direct line through the tongue
(FIGS. 13C, D). Passing the shaft directly underneath mucosa is
easier for the physician. In this configuration the force at the
retractor head is oriented laterally, and this causes the mucosa
posterior to the retractor head to be pulled taut with some degree
of indentation. In the more direct route the retraction force is
oriented close to perpendicular to the tongue surface and there is
more indentation then mucosal tension. The exact orientation at
insertion can be varied to maximize the beneficial effects for the
patient.
[0452] In another embodiment the shaft reemerges in close proximity
to the anchor and runs most of its course along the surface of the
tongue. This has the advantage of avoiding even the minimally
invasive tunnels formed by A and B. Furthermore the configurations
can be combined and the shaft can travel the entire distance under
the mucosa or can re-emerge one or more times (FIGS. 13E, F).
[0453] In another embodiment the anchor and/or the retractor can be
embedded beneath mucosa and the shaft is detachable (FIGS. 13G, H).
In a preferred embodiment the anchor/retractor would be a silastic
disc 5 mm in diameter that is implanted under the mucosa. The disc
has a 1 mm diameter extension that comes out of the pocket. The
extension ends in a 2 mm disc (FIGS. 13I, J). This extension
reversibly couples to a shaft. Preferable shafts would be
elastomeric. One preferable embodiment would be a simple medical
grade rubber band. Another embodiment is a 1.times.1 mm strip of
elastomeric material with expansion at either end to accommodate
precut keyholes for attachment to the implanted anchor/retractor.
These attachment holes would have 2 mm or greater inner holes to
allow the stretched shaft to pass over the extension and 1 mm outer
holes or clefts that slot into the extension (FIG. 13K). Materials
could be pigmented to match the color of the tongue mucosa. A
further embodiment would allow the patient to depress the elevated
extension so that it is flush with the mucosa, particularly when
not in use (FIG. 13L). Many mechanisms are known in the art to
allow reversible depression of a button like device.
[0454] A further embodiment is an anchor member composed of an
elastic sleeve slipped over the tongue blade (FIGS. 13M, N). The
shaft may be an integral part of the sleeve or a separate
attachable component. The sleeve is preferably composed of silicone
or other biocompatible elastomers. The distal end of the shaft can
be reversibly attached to the implanted retractor head. The
mechanism by which the shaft and implant are coupled may include
elastic bands, clips, magnets of opposite polarity, and other
mechanisms well known to those skilled in the art. The advantages
of this arrangement are that only a small partially embedded
implant is needed to achieve retraction.
[0455] In a further embodiment two anchors are placed in the PGFs
(FIGS. 130, P). The anchors are attachment points for an elastic
band passing over the base of tongue that serves to retract the
base, or presses upon a smaller retractor component that is
semi-implanted.
[0456] In a further embodiment an LTR anchored beneath the tongue
blade with a shaft passes through the tongue blade to an
intermediate anchor on the superior surface of the tongue. The
shaft then passes posteriorly to a semi implanted retractor member
(FIGS. 13Q, R). This allows adjustment of tension from the anchor
site beneath the tongue blade.
[0457] In a further embodiment a rigid shaft connects an anchor
member below the tongue blade to a retractor member above the
tongue blade. The retractor member is rotated forward by a sleeve
that is reversibly placed over the tongue blade. The rotation of
the retractor member, along with the rigid shaft, displaces the
tissue of the tongue base along the midline (FIGS. 13S, T)
7. Pharyngoglossal Fold (PGF) Embodiments (FIGS. 15A-15F, 16A-16L,
17A-17C, and 18A-18F)
[0458] Disclosed here are methods and devices for using the PGF as
a retractor or anchor site in order to beneficially effect the
tongue, pharyngeal walls and/or soft palate.
[0459] On both sides of the tongue thin folds of mucosa connect the
tongue to the mandible. These are called the pharyngoglossal folds
(PGF). Within these folds are the palatoglossal, superior
constrictor, styloglossus and hyoglossus muscles, from superior to
inferior respectively. The PGFs separate the oral cavity (anterior)
from the pharynx (posterior). Anterior to this attachment there is
no lateral connection of the tongue and it is freely mobile. One of
the muscles within the PGF is the palatoglossus which courses
superiorly to connect with the soft palate, thereby forming what is
seen in the mouth as the anterior tonsillar pillar.
[0460] Unexpectedly the PGF has been found to have several
advantages as a retraction site that enlarges the pharyngeal
airspace. The corrective tissue of the PGF is connected with that
of the tongue. Therefore, it has been unexpectedly found that
traction on the PGF is transmitted to the base of tongue. Moreover,
as the superior pharyngeal constrictor and palatoglossus muscles
are attached to the PGF and in turn connect with the lateral
pharyngeal walls and soft palate these structures can also be
retracted (FIGS. 14A-14E). In particular a preferred site within
PGF is its superior end where many of these muscles overlap as they
insert into the tongue. Therefore retraction at one site expands
the pharyngeal airway by simultaneously stiffening and/or
retracting the tongue base, lateral pharyngeal walls and soft
palate. All of these effects have a beneficial effect on sleep
disordered breathing.
[0461] A further advantage of the PGF is that it is easily
accessible to both the physician and patient. The PGF is not
normally seen during examination of the mouth as it is in a folded
state and hidden by the tongue surface above it. However, the PGF
can be easily palpated by sliding a finger along the floor of the
month next to the mandible, at the level of the edge of the
mandible a smooth vertical wall is reached which blocks entry into
the pharynx; this is the PGF. To visualize the PGF the tongue can
be retracted medially with a tongue blade.
[0462] A further advantage of the PGF is that it does not have a
lot of sensory innervation. The area of the mouth around the PGF is
highly sensitive. Specifically, the tonsillar pillars and the
tongue surface next to the PGF are the most sensitive areas of the
upper airway that cause reflex gagging. However, it has
unexpectedly been found that touching the PGF itself causes little
or no gagging. Moreover, even the small amount of sensation caused
by touching the PGF disappears within minutes.
[0463] A further advantage of the PGF is that it is thin and easy
to puncture yet contains enough connective tissue to provide a firm
interface with a retractor. Anatomical studies by the inventor have
shown that the PGF has few neurovascular structures and is 1-3 mm
in thickness. Therefore any piercing or puncturing of the PGF is
safe.
[0464] The invention consists of using an LTR to displace the PGF
or neighboring tissue.
[0465] The most preferable retraction would be in an anterior
direction as the retraction displaces the entire base of tongue
anteriorly thereby increasing the retroglossal and retropalatal
airspace. Also preferable is inferior retraction of the PGF as this
displaces the tongue base inferiorly thereby removing tissue volume
from the retropalatal area, the narrowest part of the upper airway.
Lateral retraction would stiffen and flatten the posterior surface
region of the tongue base. Less preferable is posterior or medial
retraction.
[0466] This retraction could be unilateral but is preferably
bilateral. This retraction could be acute, just during an
obstructive episode, or semi acute, overnight while sleeping, or
for extended durations. Extended durations of retraction would
cause tissue remodeling that would cause the tongue to tend to
remain in a more anterior position even without any force
applied.
[0467] In one embodiment an LTR is inserted across the PGF and
passes across the frenulum to attach to a similarly implanted LTR
on the opposite side (FIG. 15B).
[0468] In one embodiment the retractor lays against the PGF but the
shaft passes through the tongue (FIG. 15C) to an external
anchor.
[0469] In one embodiment the retractor is implanted within the PGF
or neighboring tongue tissue and passes anteriorly and inferiorly
to an implanted anchor in the tongue, genioglossus muscle, and/or
floor of mouth (FIG. 15D).
[0470] In one embodiment the retractor is implanted against the
superior PGF and the shaft passes inferiorly through or outside the
PGF to an anchor that is implanted against the same PGF either on
the same or opposite side (FIG. 15E). This method retracts the
superior PGF in an inferior direction.
[0471] In a further embodiment against the PGF and the shaft passes
medially and superiorly to an anchor on the superior surface of the
tongue (FIG. 15F).
[0472] In a further embodiment the retractor is implanted at the
tongue base and connects to two shafts that are placed at either
PGF (FIGS. 16C, D).
[0473] In a further embodiment a shaft placed beneath the mucosa of
the tongue base connects retractor members anterior to each PGF
(FIGS. 16E, F).
[0474] In a further embodiment, a shaft placed beneath the mucosa
of the tongue base is connected at either end to implanted magnets
in or around the PGFs (FIGS. 16G, H). External modified anchors
with magnets of opposite polarity are used to bond to the implanted
magnets and anchor them to external structures.
[0475] In a further preferred embodiment, only the retractor member
would be implanted in the PGF. The retractor would have a flange
surface near its posterior aspect that would provide the interface
against the PGF to cause anterior retraction. A second flange could
be added anteriorly to prevent displacement of the conduit. A
variety of coupling mechanisms could be used, Figure (FIGS. 16I, J)
shows a magnetic mechanism.
[0476] Magnets are implanted within each PGF and external modified
anchors with magnets of opposite polarity are used to bond to the
implanted magnets and anchor them to external structures. Many
other coupling mechanisms are known in the art, non-limiting
examples being hooks, clamps or screws. This embodiment is
minimally invasive and allows the patient a very high degree of
comfort during the day when the implant is unconnected and
therefore unloaded. A variety of different shaft and anchor
combinations can be tested without needing to replace the retractor
implant.
[0477] Another aspect of this invention is a lateral dental anchor.
This anchor may couple to the LTR using magnets, or mechanical
mechanisms known in the art. The advantage of this device is that
the PGF is very close to the mandibular teeth, and a secure but
reversible loading of the implanted LTR can therefore be achieved
with short devices. Moreover, the route from the PGF to the molar
teeth is unlikely to cause the patient significant discomfort.
[0478] In still another embodiment of this invention anchors
coupled to one of the following non-limiting list of structures
inserts into retractors on or lateral to the PGF or pass through
the PGF to tongue structures: the styloglossus, hyoglossus,
chondroglossus, pharyngeal constrictor, levator and tensor of the
palate, masetter, temporalis, pterygoid, facial, and platysma
muscles; the hyoid, mandible, facial, and vertebral bones; the
thyroid, cricoid, epiglottic cartilages; the stylohyoid,
ptyrogomandibular ligaments and other fascial structures.
8. Soft Palate And Tonsillar Folds
[0479] Disclosed here are methods and devices for retracting the
lateral pharyngeal walls and soft palate.
[0480] FIGS. 17A-17C show the basic anatomy of the internal soft
palate structures and some embodiments of this invention. The soft
palate is a thin muscular structure that separates the nasopharynx
and velopharynx from the oral cavity. It begins at the edge of the
hard palate and extends downward toward the throat. In the midline
it ends at the uvula, and on each side it divides into two folds
that surround the palatine tonsils: the anterior tonsillar fold,
also called the palatoglossal fold, inserts into the side of the
tongue near the superior PGF; the posterior tonsillar fold, also
called the palatopharyngeal fold, inserts into the lateral
pharyngeal wall.
[0481] Excess length or thickness of the soft palate decrease the
volume of the velopharynx and contribute to snoring and sleep
apnea. In addition, laxity of the soft palate, and pharyngeal walls
predisposes to airway collapse. The methods of this invention can
reversibly or persistently thin, stiffen, and/or retract the soft
palate and pharyngeal wall structures.
[0482] The loading of a soft palate LTR is analogous to the above
described embodiment in the tongue. Specifically the soft palate
LTR could rest in place unloaded, i.e. with a minimum tension
(preferably 1-100 gms, most preferably 5-15 gms) that is sufficient
to keep the shaft within tissue and the anchor and retractor
resting immobile against mucosa. The patient would therefore have
little or no sensation of the LTR's presence At night the LTR could
be loaded by placement of a modified anchor, non-limiting examples
being a bolster between the anchor and the mucosa, or connecting to
a dental device.
[0483] The exact site and orientation of the lateral LTR has a
great influence on whether the effects of the LTR are primarily to
compress or displace tissue.
[0484] FIGS. 17A-17C show some non-limiting examples of the same
anchor site at the superior PGF can have multiple preferred
embodiments with different beneficial effects:
[0485] LTR #1 in the figure is oriented to achieve inferior
displacement of the lateral aspect of the soft palate, thereby
enlarging the velopharynx.
[0486] LTR #2 passes to the midline of the soft palate. The exact
location, force and number of LTRs can be varied in order to best
treat the specific pathology of each patient.
[0487] LTR #3 passes across the tonsil to a retractor on the
pharyngeal side of the posterior tonsillar pillar. The tonsils in
sleep apnea patients often are enlarged relative to normal and this
enlargement contributes to the excess soft tissue of the upper
airway. Tension in the shaft would compress the tonsils and
decrease their volume.
[0488] LTR #4 passes from the superior PGF to the mucosa of the
tongue base. This embodiment stiffens the mucosa of the tongue base
and prevents the tongue base from deforming backward.
[0489] FIGS. 18A-18F show a variety of preferred embodiments in the
tonsillar folds.
[0490] FIGS. 19A and 19B show an embodiment of a midline LTR in the
soft palate with an anchor near the hard palate, a shaft passing
through soft tissue and a retractor head in the uvular area (FIG.
18A). The anchor element could rest against the mucosa on either
the oral side or pharyngeal side. The anchor would be available to
couple to a modified anchor on the oral side such as a dental
appliance, or a modified anchor on the pharyngeal side. The
retractor member could be inserted so it faces either forward,
downward or backward.
[0491] FIGS. 19C-19F show the effect of a modified anchor in
bolster form on the shape and position of the soft palate.
Inserting a bolster rotates, stiffens and indents the soft palate.
All of which serve to decrease the susceptibility to snoring and
airway obstruction. The mount of tension added by the bolster
preferably ranges from 1 to 500 gm, more preferably 5 to 250 gms
and most preferably 10 to 50 gms. The bolster is designed to allow
the anchor head to fit into a recess in the front surface, such
that after insertion the combined anchor bolster presents a smooth
and soft continuous surface thereby having no effect on speech or
swallowing and causing minimal discomfort to the patient.
[0492] FIGS. 19G and 19H show another preferred embodiment of the
LTR which is totally implanted.
[0493] FIGS. 19I and 19J show a further embodiment whose main
effect is to compress a thickened soft palate. The anchor and
retractor components are aligned on either side of the soft palate.
Tension in the shaft compresses and thins the tissue between
them.
[0494] FIGS. 19K and 19L show an embodiment in which restraining
shafts are anchored by the LTR and pass around the edge of the soft
palate to keep them in position.
9. Veterinarian Embodiments (FIGS. 20A-20G)
[0495] Disclosed here are methods and devices to treat sleep apnea
and related disorders in mammals.
[0496] A non-limiting example of a non-human upper airway disorder
is dorsal displacement of the soft palate (DDSP) in horses. Race
horses are superb animal athletes that place the greatest demands
on respiration. All non-human mammals have a different
configuration of their upper airways. Specifically the soft palate
and larynx are much closer and they usually interlock (FIG. 20A).
Specifically the soft palate is firmly held around the epiglottis
of the larynx so that the airway from the nose through the pharynx
and into the lungs is protected and secure. In race horses this is
of special importance because of the tremendous volume of air that
must smoothly flow into and out of the lungs with each breath
during exercise.
[0497] In some horses this interlocking of the soft palate and
epiglottis breaks down and the soft palate passes backward over the
epiglottis (20B). This displacement of the soft palate immediately
interferes with breathing and the animal stops running. Although
the cause of DDSP is not known with certainty many trainers believe
that the tongue causes the displacement by moving backward and
pushing the soft palate out of position. For this reason many
trainers actually tie the race horse's tongue forward prior to the
race, a solution that is crude and uncomfortable for the
animal.
[0498] Part of this invention are methods and devices to prevent
DDSP both by preventing backward displacement of the tongue and by
securely coupling the soft palate to the epiglottis. In humans the
conditions surrounding sleep disordered breathing involve a relaxed
tongue during sleep. In horses the situation is quite different:
the tongue and other upper airway structures are much larger and
maximally active. Therefore the LTR must be adapted to these
harsher conditions. Moreover secure prevention of backward movement
of the tongue does not allow normal swallowing. Therefore it is
necessary that the LTR be loaded immediately before exercise and
unloaded immediately afterward. Moreover this needs to be done by
the trainer, with or without the cooperation of the horse.
[0499] In one embodiment an LTR is used to prevent movement of the
tongue backwards to prevent dorsal displacement of the soft palate
in a horse. The situation in the equine patient differs in many
substantial ways from that of the human. The problem occurs when
the animal is awake and exercising at frill capacity. It is
believed that the tongue moves backward and pushes the soft palate
out of its normal position where it is interlocked with the
epiglottis (K). Therefore the retracting forces needed are much
higher than those used in humans (preferably 1 gm to 50 Kgms, more
preferably 10 gm to 10 Kgm, most preferably 100 gm to 1 Kgm). To
accommodate these forces the LTR materials are preferably composed
of stainless steel or materials of comparable tensile strength. In
one embodiment an LTR passes from the tongue base to the superior
surface of the tongue. The LTR is unloaded most of the time and
only becomes laded when it is connected to the bit of the horse's
bridle prior to exercise. In a further embodiment the LTR spans
from the tongue base through the mandible where is can be accessed
inside of the lip. A bolster is placed to load the LTR prior to
exercise.
[0500] FIG. 20D shows an embodiment of the LTR that takes advantage
of certain unique circumstances present in horses. Specifically, a
bridle is usually placed on the horse's head when racing to control
the horse, and most bridle's have a bit, a bar which passes across
the horse's mouth. This bit can be used as a modified anchor to
couple and load the LTR.
[0501] Alternative embodiments secure the soft palate and
epiglottis together. FIGS. 20E and 20F an embodiment wherein LTR
passes from the soft palate to the epiglottis to resist
displacement, and if it occurs, to rapidly restore the interlocked
configuration. FIG. 20G shows an embodiment where an LTR from each
PGF attaches to the lateral aspects of each soft palate.
10. Non-Invasive Embodiments (FIGS. 21A-21H, 22A-22H, and
23A-23K)
[0502] Disclosed here are methods and devices for non-invasively
retracting mucosa and displacing soft tissue volume for the
treatment of sleep apnea and related disorders. A major advantage
is that no surgical procedure is needed, and non-invasive devices
can be easily inserted and removed by the patient.
[0503] At present the only effective non-invasive therapy for sleep
apnea is CPAP. CPAP displaces the soft tissue with air pressure
and, although effective in many cases, it is uncomfortable for the
patient and has a very low compliance rate. The only other
non-invasive therapies which have some effect on sleep apnea are
the dental devices. Dental devices work by moving the jaw down and
forward, thereby indirectly moving the entire floor of mouth and
tongue. By this method the airway is expanded and the mucosa
connecting the jaw to the pharynx is slightly stretched and
stiffened. Unfortunately the joint connecting the jaw to the skull
can only be stretched a small amount so that there is a limit to
how much the airway can be expanded. Therefore, at present, dental
devices are only effective in some mild cases.
[0504] It is not obvious how any LTR could retract the tongue and
other soft tissue without puncturing, mucosa. The tongue and
pharynx are highly sensitive to contact and any stimulation causes
gagging. Moreover, the whole region is covered with slippery mucosa
and is always moving. Therefore it is not obvious that a device can
remain in place without some firm anchoring to tissue.
[0505] In one embodiment a retractor `hooks` the PGF much like
eyeglasses hook over the ear (FIGS. 21B and C). The retractor lies
within the groove formed by the base of tongue and the lateral
pharyngeal wall with its main contact along the vertical back
surface of the PGF. In one embodiment the retractor is preferably
thin, soft and form fitted to comfortably distribute force to the
mucosa. A non-limiting example is a soft gel like silicone. The
length of the retractor is preferably 1 mm to 100 cm, more
preferably 0.5 cm to 5 cm, most preferably 1 cm to 2 cm. The
retractor can extend downward as far as the esophagus and in some
embodiments retract the upper esophageal sphincter, the pyriform
sinuses, the vocal folds, the aryepiglottic folds, the epiglottis
and/or the lateral pharyngeal walls.
[0506] Another preferable shape for the retractor is a wedge shape
as shown in FIG. 21H. The wider plane of the wedge would preferably
be 1-10 mm wide. This width compresses the tongue base and
decreases its compliance, thereby helping to prevent its posterior
collapse. The wider base can then also coax the tongue base
anteriorly (FIGS. 21G and H).
[0507] In some embodiments the shaft passes directly from the top
of the retractor over the PGF to connect with one or more of the
anchoring sites disclosed herein. The closest structures are the
teeth and particularly the molars. Dental appliances that are
affixed to molars are well known in the art. These appliances can
have a wide variety of mechanisms to attach to the shaft. One
common method similar to that used in orthodontics is to use rubber
bands. In this case a rubber band would attach to the retractor at
one end and the anchor on a molar tooth at the other. The advantage
of this embodiment is that the device is easily removable and
replaceable, completely adjustable, and the distance traveled by
the shaft to anchor could be very short, thereby achieving the goal
with minimal patient discomfort.
[0508] The hook retractor can be used at many sites disclosed
herein. However, to remain in place the hook requires that it be
loaded while in position. The PGF site is advantageous as the
retractor is surrounded by tissue on all sides and even the top is
covered by the overhanging lateral part of the tongue.
[0509] In another preferred embodiment of this invention the
retractor is designed to remain attached to the tissue fold
indefinitely by non-invasive means. In one preferred embodiment the
mechanical retractor is clipped over the tissue fold so that it can
remain in place for extended periods without connection to an
anchor (FIGS. 22A-22H). Tissue folds are malleable such that
compression at the ends of the clips indents the tissue and resists
its migration out of position (22A). Compressive force at the ends
of the arms of the clip would preferably be mechanical. These
forces may be generated by the plastic physical properties of the
clip, a spring incorporated at its lower end, an inserted length of
nitinol or other material that maintains force, or by magnets
within the anchor/retractor components (22B). Magnets can also be
used to reversibly couple to a modified anchor. This embodiment can
both compress the mucosa and retract the edge of the soft tissue
fold (22C). Two clips can be connected by a shaft that is exerting
force in an expanding direction (protract or lengthen) (22D).
[0510] The clip non-invasive retractors can be used in all sites
within the upper airway where mucosal folds are present or where
they can be formed by grasping tissue. These include without
limitation, the PGF, frenulum, lateral tongue surface, tonsillar
folds (22E, F), soft palate (22G), pharyngeal walls, floor of the
mouth, and aryepiglottic fold. Some of these sites have extensive
sensory innervation, however, so long as the contact between the
clip and mucosa is stable and immobile the sensation disappears
within minutes. This loss of sensation is called habituation and is
well known to sensory physiologists. The stability of the retractor
to mucosa contact is increased by the use of adhesives known in the
art. Adhesives effective on mucosa include but are not limited to
fibrin, hydrogels, and/or cyanoacrylic glues. It is also important
that the site for the clip as well as the shaft and anchor be
placed such that the least amount of dynamic contact occurs between
components and mucosa. In addition, for persistent use the
compression between the arms of the clip should not exceed the
pressure at which capillary blood circulation stops, called the
perfusion pressure, which is about 25 mm Hg or 34 cm H2O.
[0511] Another non-invasive embodiment of this invention are
methods and devices that use a vacuum to retract or displace soft
tissue. Vacuum devices are used in two different methods: a vacuum
can serve to suck a retractor head onto a mucosal surface thereby
attaching the retractor; the vacuum can be applied over a larger
segment of the tongue and cause displacement of tongue tissue into
the suction. As the volume of the tongue is constant the
displacement of tissue must come from other parts of the tongue,
most preferably the tongue base.
[0512] In one method a vacuum is used to couple a retractor to
mucosa. Then the retractor can be attached to modified anchors as
described herein. A second method of using a vacuum is to displace
soft tissue volume. This is preferably used on the tongue by a
relatively larger device that sucks tissue volume into the vacuum
device and thereby changes the shape of the tongue such that volume
is removed from the tongue base.
[0513] The vacuum retractor could be a suction cup type well known
in the art and the vacuum formed by pressing against the mucosa.
Preferably the interface between device and mucosa has well defined
edges with interior walls at 90.degree. or greater. This embodiment
suctions small amount s of tissue into the opening and their
presence provides resistance to shear forces acting at the suction
site (23J). The vacuum retractor could also be connected to a
vacuum source via a tube leading from the vacuum retractor out of
the mouth. In another embodiment a small air pump could be located
in the mouth. This pump may be passive, composed of a small bladder
with a one way valve such that movements of the tongue or jaw that
compress the bladder force air out of it through the one way valve.
The elastic drive of the bladder to return to its larger volume
shape forms the vacuum.
[0514] After the vacuum retractor couples to the mucosa it can be
displaced forward by a shaft similar to those used for the other
embodiments. The vacuum retractor could be a single suction
interface or multiple smaller interfaces; mini suction cups.
Viscous mucoid material or adhesive could be applied to the mucosa
to aid in maintaining a seal. The vacuum retractor is most
preferably applied to the anterior surface of the PFG. Other
preferred sites are the lateral and inferior tongue surface. Those
skilled in the art can understand that the vacuum could be applied
at all locations that retraction is beneficial.
[0515] Another embodiment of this invention is to increase the
pharyngeal airspace by depressing the floor of the mouth. The floor
of the mouth (FOM) is composed of muscles and other soft tissue
that attaches to the hyoid posteriorly and the mandible anteriorly
and laterally. The tongue sits on the FOM and follows its
movements. For example when the jaw is moved forward or downward
the tongue moves along with it. Similarly when the hyoid bone moves
forward it displaces the back of the tongue in the same direction.
Some surgical procedures try to take advantage of this relationship
by wiring the hyoid bone in a more forward position by wiring it to
the front of the mandible. Unfortunately the hyoid bone has many
other attachments that resist being repositioned.
[0516] This invention does not focus on moving the boney
attachments of the FOM but instead on moving the soft tissue of the
FOM itself. Specifically, the bottom of the tongue (root of the
tongue) that rests on the FOM is triangular shaped and smaller than
the overall area of the FOM (FIGS. 23A-23K). Therefore the FOM can
be reached between the tongue root and the mandible. When this area
is depressed the root of the tongue is depressed as well. Although
the entire exposed FOM can be depressed, this is inefficient, as
the most important area to move is the tongue base.
[0517] In the preferred embodiment the area of the FOM around the
tongue base is depressed thereby moving the tongue base down and
increasing the pharyngeal airspace. For practical purposes the PGF
places a limit on how far back the FOM can be reached. In one
embodiment an LTR with a silicon bolster of 0.5 cm.times.0.5
cm.times.1 cm is situated longitudinally alongside the undersurface
of the tongue with one end abutting the PGF. Downward pressure is
achieved by a dental appliance attached to the molar teeth. Not all
of the downward movement of the local area of FOM depression is
transferred to the tongue. However, any significant increase in the
pharyngeal airspace is beneficial.
[0518] In addition to depression of the FOM, displacement force can
be exerted forward (anterior), inward (medial) or outward
(lateral). Forward displacement is beneficial because the
pharyngeal airspace is expanded to the extent that the tongue base
also moves forward. Inward movement is beneficial if both sides
exert a grasping force on the tongue and thereby resist its
backward collapse. Outward movement is also beneficial to the
extent that it stretches and tenses tongue tissue thereby also
preventing backward collapse.
[0519] It is to be understood that the exemplary embodiments are
merely illustrative of the invention and that many variations of
the above-described embodiments can be devised by one skilled in
the art without departing from the scope of the invention. It is
therefore intended that all such variations be included within the
scope of the following claims and their equivalents.
* * * * *