U.S. patent application number 10/665746 was filed with the patent office on 2004-04-15 for implantable stimulation device for snoring treatment.
This patent application is currently assigned to Restore Medical, Inc.. Invention is credited to Conrad, Timothy R., Knudson, Mark B., Nickoloff, Robert S..
Application Number | 20040073272 10/665746 |
Document ID | / |
Family ID | 23618725 |
Filed Date | 2004-04-15 |
United States Patent
Application |
20040073272 |
Kind Code |
A1 |
Knudson, Mark B. ; et
al. |
April 15, 2004 |
Implantable stimulation device for snoring treatment
Abstract
The present disclosure relates to methods and apparatuses for
treating snoring by implanting a stimulating electrode into a
patient. The electrode is placed in stimulating contact with an
airway passage-controlling muscle of the patient. The electrode is
energized to contract the muscle and alter the airway passage.
Inventors: |
Knudson, Mark B.;
(Shoreview, MN) ; Nickoloff, Robert S.; (St. Paul,
MN) ; Conrad, Timothy R.; (Eden Prairie, MN) |
Correspondence
Address: |
MERCHANT & GOULD PC
P.O. BOX 2903
MINNEAPOLIS
MN
55402-0903
US
|
Assignee: |
Restore Medical, Inc.
St. Paul
MN
|
Family ID: |
23618725 |
Appl. No.: |
10/665746 |
Filed: |
September 19, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10665746 |
Sep 19, 2003 |
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09409018 |
Sep 29, 1999 |
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6636767 |
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Current U.S.
Class: |
607/48 |
Current CPC
Class: |
A61N 1/3601 20130101;
A61N 1/36017 20130101; A61N 1/37205 20130101 |
Class at
Publication: |
607/048 |
International
Class: |
A61N 001/18 |
Claims
What is claimed is:
1. A method for treating snoring comprising: implanting a
stimulating electrode into a patient with said electrode in
stimulating contact with an airway passage-controlling muscle of
said patient; and energizing said electrode to contract said muscle
and alter said airway passage.
2. A method according to claim 1 wherein said electrode is
energized by electrically coupling said electrode through an
electromagnetic field to a controller not implanted in said
patient.
3. A method according to claim 2 wherein said controller is
contained with an appliance sized to be removably placed within a
mouth cavity of said patient and with said controller electrically
coupled to said electrode when said appliance is placed within said
mouth cavity.
4. A method according to claim 1 wherein said muscle is a muscle of
the soft palate.
5. A method according to claim 1 wherein said muscle is a muscle of
the tongue.
6. A method according to claim 1 wherein said muscle is a muscle of
the pharnyx.
7. A method according to claim 4 wherein said muscle is selected
from at least one of the Levator veli paltini, the
Palatopharyngeous and the Palatoglossus muscles.
8. A method according to claim 5 wherein said muscle is selected
from at least one of the Genioglossus and Geniohyoid muscles.
9. A method according to claim 6 wherein said muscle is selected
from at least one of the Superior, Middle and Inferior pharyngeal
constrictor, the Salpingopharyngeous and the Stylopharyngeous
muscles.
10. An apparatus for treating snoring of a patient, said apparatus
comprising: a stimulating electrode adapted to be implanted into a
patient with said electrode in stimulating contact with an airway
passage-controlling muscle of said patient; and a control member
for energizing said electrode to contract said muscle and alter
said airway passage.
11. An apparatus according to claim 10 wherein said electrode and
control member include cooperating components for inductively
coupling said control member and said electrode.
12. An apparatus according to claim 11 wherein said control member
is carried on an appliance adapted to be removably placed,
non-invasively in mouth of said patient.
Description
BACKGROUND
[0001] 1. Field of the Invention
[0002] This invention is directed to method and apparatus for
treating snoring.
[0003] 2. Description of the Prior Art
[0004] Snoring has received increased scientific and academic
attention. One publication estimates that up to 20% of the adult
population snores habitually. Huang, et al., "Biomechanics of
Snoring", Endeavour, Vol. 19, No. 3, pp. 96-100 (1995). Snoring can
be a serious cause of marital discord. In addition, snoring can
present a serious health risk to the snorer. In 10% of habitual
snorers, collapse of the airway during sleep can lead to
obstructive sleep apnea syndrome. Id.
[0005] Notwithstanding numerous efforts to address snoring,
effective treatment of snoring has been elusive. Such treatment may
include mouth guards or other appliances worn by the snorer during
sleep. However, patients find such appliances uncomfortable and
frequently discontinue use (presumably adding to marital
stress).
[0006] Surgical treatments have been employed. One such treatment
is uvulopalatopharyngoplasty. In this procedure, so-called laser
ablation is used to remove about 2 cm of the trailing edge of the
soft palate thereby reducing the soft palate's ability to flutter
between the tongue and the pharyngeal wall of the throat. The
procedure is frequently effective to abate snoring but is painful
and frequently results in undesirable side effects. Namely, removal
of the soft palate trailing edge comprises the soft palate's
ability to seal off nasal passages during swallowing and speech. In
an estimated 25% of uvulopalatopharyngoplasty patients, fluid
escapes from the mouth into the nose while drinking. Huang, et al.,
supra at 99. Uvulopalatopharyngoplasty (UPPP) is also described in
Harries, et al., "The Surgical treatment of snoring", Journal of
Larvngology and Otology, pp. 1105-1106 (1996) which describes
removal of up to 1.5 cm of the soft palate. Assessment of snoring
treatment is discussed in Cole, et al., "Snoring: A review and a
Reassessment", Journal of Otolaryngology, pp. 303-306 (1995).
[0007] Huang, et al., supra, describe the soft palate and palatal
snoring as an oscillating system which responds to airflow over the
soft palate. Resulting flutter of the soft palate (rapidly opening
and closing air passages) is a dynamic response generating sounds
associated with snoring. Huang, et al., propose an alternative to
uvulopalatopharyngoplas- ty. The proposal includes using a surgical
laser to create scar tissue on the surface of the soft palate. The
scar is to reduce flexibility of the soft palate to reduce palatal
flutter. Huang, et al., report initial results of complete or
near-complete reduction in snoring and reduced side effects.
[0008] Surgical procedures such as uvulopalatopharyngoplasty and
those proposed by Huang, et al., continue to have problems. The
area of surgical treatment (i.e., removal of palatal tissue or
scarring of palatal tissue) may be more than is necessary to treat
the patient's condition. Surgical lasers are expensive. The
proposed procedures are painful with drawn out and uncomfortable
healing periods. The procedures have complications and side effects
and variable efficacy (e.g., Huang, et al., report promising
results in 75% of patients suggesting a full quarter of patients
are not effectively treated after painful surgery). The procedures
may involve lasting discomfort. For example, scar tissue on the
soft palate may present a continuing irritant to the patient.
Importantly, the procedures are not reversible in the event they
happen to induce adverse side effects not justified by the benefits
of the surgery.
[0009] Electrical stimulation of the soft palate has been suggested
to treat snoring and obstructive sleep apnea. See, e.g., Schwartz,
et al., "Effects of electrical stimulation to the soft palate on
snoring and obstructive sleep apnea", J. Prosthetic Dentistry, pp.
273-281(1996). Devices to apply such stimulation are described in
U.S. Pat. Nos. 5,284,161 and 5,792,067. Such devices are appliances
requiring patient adherence to a regimen of use as well as
subjecting the patient to discomfort during sleep. Alternatively,
these devices must be used during the day for a period of time
causing disruption of daily activity, interference with daily life.
This may generally be assumed to cause them to be prone to a
significant risk of non-compliance by the wearer. Such devices,
though have met with some success in treating disorders such as
snoring and Obstructive Sleep Apnea.
SUMMARY OF THE INVENTION
[0010] According to a preferred embodiment of the present
invention, a method and apparatus are disclosed for treating
snoring of a patient. The invention includes implanting a
stimulating electrode into a patient. The electrode is placed in
stimulating contact with an airway passage-controlling muscle of
the patient. The electrode is energized to contract the muscle and
alter the airway passage.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a side sectional view of a portion of a human head
showing a soft palate in a relaxed state and in relation in
adjacent anatomical features;
[0012] FIG. 2 is a portion of the view of FIG. 1 showing the soft
palate in a flexed state;
[0013] FIG. 3 is a front view of an interior of the mouth shown in
FIG. 1 and showing an area to be ablated according to a first prior
art surgical procedure;
[0014] FIG. 4 is the view of FIG. 3 and showing an area to be
scarred according to a second prior art surgical procedure;
[0015] FIG. 5 is a schematic representation of a spring-mass system
model of the soft palate;
[0016] FIG. 6 is the view of FIG. 1 showing electrodes placed in
the muscles of the soft palate, tongue and throat; and
[0017] FIG. 7 is a schematic representation of a pacing electrode
inductively coupled to a control device.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0018] For ease of understanding the present invention, the
dynamics of snoring are explained with reference to FIGS. 1-5. The
hard palate HP overlies the tongue T and forms the roof of the
mouth M. The hard palate HP includes a bone support B and does not
materially deform during breathing. The soft palate SP is soft and
is made up of mucous membrane, fibrous and muscle tissue extending
rearward from the hard palate HP. A leading end LE of the soft
palate SP is anchored to the trailing end of the hard palate HP. A
trailing end TE of the soft palate SP is unattached. Since the soft
palate SP is not structurally supported by bone or hard cartilage,
the soft palate SP droops down from the plane of the hard palate HP
in an arcuate geometry of repose.
[0019] The pharyngeal airway passes air from the mouth M and the
nasal passages N into the trachea TR. The portion of the pharyngeal
airway defined between opposing surfaces of the upper surface of
the soft palate SP and the wall of the throat is the nasopharynx
NP.
[0020] During normal breathing, the soft palate SP is in the
relaxed state shown in FIG. 1 with the nasopharynx NP unobstructed
and with air free to flow into the trachea TR from both the mouth M
and the nostrils N.
[0021] During swallowing, the soft palate SP flexes and extends (as
shown in FIG. 2) to close the nasopharynx NP thereby preventing
fluid flow from the mouth M to the nasal passages N.
Simultaneously, the epiglottis EP closes the trachea TR so that
food and drink pass only into the esophagus ES and not the trachea
TR. The soft palate SP is a valve to prevent regurgitation of food
into the nose N. The soft palate SP also regulates airflow through
the nose N while talking. Since the soft palate SP performs such
important functions, prior art techniques for surgically altering
the soft palate SP can compromise these functions.
[0022] The majority of snoring is caused by the soft palate SP
flapping back and forth. If breathing is solely through the nose N
with the mouth closed, the trailing edge TE of the soft palate SP
is sucked into the nasopharyngeal space NP obstructing the airway
and subsequently falls opening the airway in a repeating cycle.
When the mouth is open, air flows over the upper and lower surfaces
of the soft palate SP causing the soft palate SP to flap up and
down alternating in obstructing the oral and nasal passageways M,
N. The snoring sound is generated by impulses caused by rapid
obstruction and opening of airways. Huang, et al., state the airway
passage opening and closing occurs 50 times per second during a
snore. Huang, et al., utilizing a spring-mass model (FIG. 5) to
illustrate oscillation of the soft palate in response to airflow
(where the soft palate is the ball B of mass depending by a spring
S from a fixed anchor A).
[0023] Huang, et al., analogize the shortening of the soft palate
SP in uvulopalatopharyngoplasty as effectively raising the critical
air flow speed at which soft palate flutter will occur. The shaded
area SA in FIG. 3 shows the area of the trailing end TE of the soft
palate SP to be removed during this procedure. The alternative
procedure proposed by Huang, et al., reduces the flexibility of the
soft palate SP through surface scarring which is asserted as
effecting the critical flow speed. The shaded area SA' in FIG. 4
shows the area to be scarred by this alternate procedure. In FIG.
4, dashed line L shows the demarcation between the soft and hard
palates.
[0024] The present invention is directed to a method and apparatus
for altering the dynamic response of the soft palate by altering
airflow past the soft palate. With reference to the spring-mass
model (FIG. 5), the soft palate is moved by airflow. Airflow
through an orifice varies in response to the orifice size. The
present invention alters the size of the air passage through a
minimally invasive surgical implant to allow stimulation of airway
defining muscles of the oro-pharynx (i.e., mouth and throat).
[0025] The present invention stimulates muscles of one or more of
the soft palate SP, tongue T and back of the throat. In the soft
palate SP, these muscles include, but are not limited to, the
Levator veli paltini, the dextera, the Palatopharyngeous and the
Palatoglossus muscles. At the back of the throat, these muscles
include, but are not limited to, the Superior, Middle and Inferior
pharyngeal constrictor, the Salpingopharyngeous and the
Stylopharyngeous muscles. In the tongue T, these muscles include,
but are not limited to, the Genioglossus and Geniohyoid
muscles.
[0026] Stimulating the muscles of the soft palate, tongue and
throat is intended to alter the dynamic response of the soft palate
to airflow. Namely, stimulation of the soft palate SP causes the
soft palate to move away from the tongue T, stimulation of the
tongue T causes the tongue T to move away from the soft palate SP,
and stimulation of the back of the throat causes the throat to move
rearwardly. Alone or in combination, these actions increase the
size of the airway thereby decreasing air velocity and the
disrupting force which would otherwise cause oscillation of the
soft palate SP.
[0027] Stimulation of the muscles is accomplished by implanted
electrodes 10, 10' and 10" placed in the airway passage-defining
muscles (identified above) of the soft palate SP, tongue T and back
of throat (as illustrated in FIG. 6). Implantable muscle
stimulating electrodes are well known and may be such as those used
in cardiac pacing.
[0028] The implant 10, 10', 10" can be positioned and stimulated in
a plurality of ways to alter the shape of the airway, to change the
dynamic response of the airway tissues or a combination of both.
Unlike the prior art surgical techniques, the electrodes 10, 10',
10" that will be described are easy to insert in a small incision
resulting in reduced patient discomfort and are not exposed to the
interior of the mouth (such as the surface scarring of Huang, et
al.) as a patient irritant. Also, as will be described, the degree
of dynamic remodeling and stimulation pattern can be fine tuned
avoiding the need for excessive anatomical modification and are
reversible in the event of adverse consequences.
[0029] The present invention permits the surgeon to apply
stimulation to various muscles until the desired alteration in
airway area and tone is achieved so that snoring inducing
oscillation is abated at normal airflow. The individual electrodes
10, 10', 10" may be placed into the soft palate, tongue or throat
muscles through small individual incisions closed by sutures which
is much less traumatic than the gross anatomical destruction of
uvulopalatopharyngoplasty or the large surface area scarring
proposed by Huang, et al.
[0030] A control device 20 is provided for controlling the
electrodes 10, 10', 10" . The control device 20 is shown as a
removable appliance (schematically shown in FIG. 6 with it being
appreciated that appliances for placement in the mouth are well
known) which fits the form of the hard palate or sub-lingual
spaces.
[0031] The control device 20 is electrically coupled to the
electrodes 10, 10', 10" through electromagnetic coupling which
avoids the need for electrode leads being exposed from the implants
10, 10', 10". Specifically, the electrode 10 (shown in FIG. 7 and
it being appreciated that electrodes 10', 10" are of similar
construction) includes a pacing electrode 12 for stimulating muscle
in response to a signal through the electrode 10. Leads 14 connect
the pacing electrode 12 to an inductive winding 16. In use, the
entire electrode 10 (i.e., each of the components of the pacing
electrode 12, leads 14 and winding 16) are imbedded in the patient
and not exposed.
[0032] The control device 20 is shown schematically and includes an
inductive winding 22 connected to a control circuit 24. Control
circuit 24 is only shown schematically. Control circuits for pacing
electrodes are well known and widely used in cardiac pacing. In the
present invention, preferably none of the components of the control
device 20 (i.e., the winding 22 and circuit 24) are implanted.
Instead, preferably such components are contained in the removable
oral appliance control device 20 although some elements (e.g., a
battery may be worn externally by the patient).
[0033] The control winding 22 is positioned on the control device
20 to be inductively coupled to the electrode winding 16 when the
control device 20 is in place. In the event multiple electrodes 10,
10', 10" are placed in multiple muscles, the control device 20 may
contain a plurality of windings 22 each uniquely tuned to the
windings of the electrodes 10, 10',10" such that each electrode 10,
10', 10" may be uniquely paced. Also, each of the electrodes 10,
10', 10" can be provided with filter circuits to pass only desired
signals to the pacing electrodes.
[0034] The control device 20 sends a pulsitile signal to the
electrode 10 through the inductive coupling of windings 16 and 22.
In response, the electrode 10 causes pacing contraction of the
muscle. Preferably, the pacing is selected to contract the muscle
up to and including tetanic contraction.
[0035] With the present invention, the muscle is contracted to
increase the size of the airway and reduce palatal flutter. The
amount of pacing can be tuned to the unique physiology of the
patient. The control device need only be used during sleep. It is
anticipated that regular use of the control device 20 results in
improved tone of the paced muscles reducing or eliminating future
need to use the control device 20. Unlike the appliances of U.S.
Pat. Nos. 5,284,161 and 5,792,067, the present device has more
effective pacing since muscles are being paced directly by
implanted electrodes rather than through less efficient surface
stimulation. Further, the present invention contemplates pacing of
all muscles defining the airway passage and not just the soft
palate.
[0036] Having described the invention, alternatives and embodiments
may occur to one of skill in the art. It is intended that such
modifications and equivalents shall be included within the scope of
the following claims.
* * * * *