U.S. patent application number 12/821912 was filed with the patent office on 2010-12-23 for airway implant and methods of making and using.
This patent application is currently assigned to Pavad Medical, Inc.. Invention is credited to Wally S. Buch, George S. Choi, Anant V. Hegde.
Application Number | 20100319711 12/821912 |
Document ID | / |
Family ID | 36072618 |
Filed Date | 2010-12-23 |
United States Patent
Application |
20100319711 |
Kind Code |
A1 |
Hegde; Anant V. ; et
al. |
December 23, 2010 |
AIRWAY IMPLANT AND METHODS OF MAKING AND USING
Abstract
A system and device for maintaining and/or creating patency in
airways is disclosed. The methods of using the system and device
are also disclosed. The system includes a power source that
energizes a electro-active polymer implant. The energized polymer
implant provides stiffness and shape to the airway, thereby
minimizing collapse or deformation of the airway. A method of
making the device is also disclosed.
Inventors: |
Hegde; Anant V.; (Newark,
CA) ; Choi; George S.; (Redwood City, CA) ;
Buch; Wally S.; (Atherton, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER, EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
Pavad Medical, Inc.
Fremont
CA
|
Family ID: |
36072618 |
Appl. No.: |
12/821912 |
Filed: |
June 23, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10946435 |
Sep 21, 2004 |
|
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12821912 |
|
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Current U.S.
Class: |
128/848 |
Current CPC
Class: |
A61N 1/0517 20130101;
A61F 2/00 20130101; A61F 5/566 20130101; A61F 2210/0023 20130101;
Y10S 602/902 20130101; A61L 31/125 20130101; A61L 31/14 20130101;
A61C 7/00 20130101; A61N 1/0519 20130101; A61N 1/3601 20130101;
A61N 1/0548 20130101; A61B 2017/248 20130101; A61F 5/56
20130101 |
Class at
Publication: |
128/848 |
International
Class: |
A61F 5/56 20060101
A61F005/56 |
Claims
1. An implantable device for maintaining and/or creating airway
patency of a biological subject, comprising: a patency element that
changes shape in response to an electrical stimulus and comprises
an electro-active polymer.
2. The device of claim 1, wherein the electro-active polymer
comprises an ion exchange polymer.
3. The device of claim 1, wherein the electro-active polymer
comprises an ion exchange polymer metal composite.
4. The device of claim 1, wherein the electro-active polymer
comprises an ionomer base material.
5. The device of claim 1, wherein the electro-active polymer
comprises perfluorinated polymer.
6. The device of claim 1, wherein the electro-active polymer
comprises polytetrafluoroethylene.
7. The device of claim 1, wherein the electro-active polymer
comprises polyfluorosulfonic acid.
8. The device of claim 1, wherein the electro-active polymer
comprises perfluorosulfonate.
9. The device of claim 1, wherein the electro-active polymer
comprises polyvinylidene fluoride.
10. The device of claim 1, wherein the electro-active polymer
comprises hydrophilic polyvinylidene fluoride.
11. The device of claim 1, wherein the electro-active polymer
comprises polyethylene.
12. The device of claim 1, wherein the electro-active polymer
comprises polypropylene.
13. The device of claim 1, wherein the electro-active polymer
comprises polystyrene.
14. The device of claim 1, wherein the electro-active polymer
comprises polyaniline.
15. The device of claim 1, wherein the electro-active polymer
comprises polyacrylonitrile.
16. The device of claim 1, wherein the electro-active polymer
comprises cellophane.
17. The device of claim 1, wherein the electro-active polymer
comprises cellulose.
18. The device of claim 1, wherein the electro-active polymer
comprises regenerated cellulose.
19. The device of claim 1, wherein the electro-active polymer
comprises cellulose acetate.
20. The device of claim 1, wherein the electro-active polymer
comprises polysulfone.
21. The device of claim 1, wherein the electro-active polymer
comprises polyurethane.
22. The device of claim 1, wherein the electro-active polymer
comprises polyvinyl alcohol.
23. The device of claim 1, wherein the electro-active polymer
comprises polyvinyl acetate.
24. The device of claim 1, wherein the electro-active polymer
comprises polyvinyl pyrrolidone.
25. The device of claim 1, wherein the electro-active polymer
comprises a biocompatible conductive material.
26. The device of claim 25, wherein the biocompatible conductive
material comprises platinum.
27. The device of claim 25, wherein the biocompatible conductive
material comprises gold.
28. The device of claim 25, wherein the biocompatible conductive
material comprises silver.
29. The device of claim 25, wherein the biocompatible conductive
material comprises palladium.
30. The device of claim 25, wherein the biocompatible conductive
material comprises copper.
31. The device of claim 25, wherein the biocompatible conductive
material comprises carbon.
32. The device of claim 1, wherein the patency element comprises a
three dimensional shape.
33. The device of claim 1, wherein the patency element comprises a
substantially rectangular shape.
34. The device of claim 1, wherein the patency element comprises a
substantially triangular shape.
34. The device of claim 1, wherein the patency element comprises a
substantially round shape.
35. The device of claim 1, wherein the patency element comprises a
substantially trapezoidal shape.
36. The device of claim 1, wherein the patency element comprises a
shape slots that are perpendicular to the axis.
37. The device of claim 1, wherein the patency element comprises
slots that are parallel to the longitudinal axis.
38. The device of claim 1, wherein the patency element comprises a
flat strip.
39. The device of claim 1, wherein the patency element comprises a
rod.
40. The device of claim 1, wherein the patency element comprises a
cylindrical tube.
41. The device of claim 1, wherein the patency element comprises an
arch.
42. The device of claim 42, wherein the arch has a uniform
thickness.
43. The device of claim 42, wherein the arch has a varying
thickness.
44. The device of claim 1, wherein the patency element comprises a
coil.
45. The device of claim 1, wherein the patency element comprises
perforations.
46. The device of claim 1, wherein the patency element comprises
slots.
47. The device of claim 1, wherein the patency element comprises a
first layer of the electroactive polymer.
48. The device of claim 48, wherein the patency element comprises a
second layer of the electroactive polymer.
49. The device of claim 48, wherein the patency element comprises
an insulation layer separating the first layer of the electroactive
polymer from the second layer of the electroactive polymer.
50. The device of claim 50, wherein the insulation layer comprises
silicone.
51. The device of claim 50, wherein the insulation layer comprises
polyurethane.
52. The device of claim 50, wherein the insulation layer comprises
polyimide.
53. The device of claim 50, wherein the insulation layer comprises
nylon.
54. The device of claim 50, wherein the insulation layer comprises
polyester.
55. The device of claim 50, wherein the insulation layer comprises
polymethylmethacrylate.
56. The device of claim 50, wherein the insulation layer comprises
polymethylmethacrylate.
57. The device of claim 50, wherein the insulation layer comprises
neoprene.
58. The device of claim 50, wherein the insulation layer comprises
styrene butadiene styrene.
59. The device of claim 50, wherein the insulation layer comprises
polyvinyl acetate.
60. The device of claim 1, wherein the patency element has a
non-energized configuration, and wherein the patency element is
soft in the non-energized configuration.
61. The device of claim 1, wherein the patency element has an
energized configuration, and wherein the patency element in the
energized configuration is stiffer than the patency element in the
non-energized configuration.
62. The device of claim 1, wherein the patency element has a
pre-set non-energized configuration, and wherein the patency
element is soft in the pre-set non-energized configuration.
63. The device of claim 63, wherein the pre-set non-energized
configuration is substantially similar to the geometry of the
patient's airway where the device is implanted.
64. The device of claim 64, wherein the patency element has a
pre-set energized configuration when the patency element is
energized, and wherein the patency element in the pre-set energized
configuration is stiffer than the patency element in the pre-set
non-energized configuration.
65. The device of claim 63, wherein the patency element in the
pre-set non-energized configuration is substantially equal to the
patency element in the energized configuration.
66. The device of claim 66, wherein the pre-set non-energized
configuration is substantially similar to the geometry of the
airway where the device is implanted.
67. The device of claim 1, wherein the patency element comprises a
coating.
68. The device of claim 68, wherein the coating isolates the
patency element from body fluids.
69. The device of claim 68, wherein the coating's dielectric
strength is sufficient enough to electrically isolate the patency
element.
70. The device of claim 68, wherein the coating is configured to
minimize tissue growth on the patency element.
71. The device of claim 68, wherein the coating is configured to
promote tissue growth on the patency element.
72. The device of claim 68, wherein the coating comprises
poly-L-lysine.
73. The device of claim 68, wherein the coating comprises
poly-D-lysine.
74. The device of claim 68, wherein the coating comprises
polyethylene glycol.
75. The device of claim 68, wherein the coating comprises polyvinyl
alcohol.
76. The device of claim 68, wherein the coating comprises polyvinyl
acetate.
77. The device of claim 68, wherein the coating comprises
hyaluronic acid.
78. The device of claim 68, wherein the coating comprises
methylmethacrylate.
79. An implantable device for maintaining and/or creating patency
of a lumen of a biological subject, comprising: an electro-active
patency element; and an implantable transducer in electrical
communication with the patency element.
80. The device of claim 80, wherein the lumen comprises an
airway.
81. The device of claim 80, wherein the patency element comprises
an electro-active polymer.
82. The device of claim 82, wherein the electro-active polymer
comprises an ion exchange polymer-metal composite.
83. The device of claim 80, further comprising a conductive lead
attached to the electroactive patency element and the implantable
transducer.
84. The device of claim 80, further comprising a conductive lead in
electrical communication with the electro-active patency element
and the implantable transducer.
85. The device of claim 80, further comprising a power supply in
electrical communication with the electro-active patency
element.
86. The device of claim 86, wherein the power supply comprises a
battery.
87. The device of claim 86, wherein the power supply comprises a
capacitor.
88. The device of claim 80, further comprising a battery in
electrical communication with the implantable transducer.
89. The device of claim 80, further comprising a mouthpiece in
communication with the implantable transducer.
90. The device of claim 90, wherein the mouthpiece comprises a
dental retainer.
91. The device of claim 91, wherein the dental retainer comprising
a induction coil and a power source.
92. The device of claim 92, wherein the power source is a
disposable battery.
93. The device of claim 92, wherein the power source is a
rechargeable battery.
94. The device of claim 91, wherein the dental retainer further
comprising a pulsewidth-modulation circuit.
95. The device of claim 91, wherein the dental retainer is custom
fit for the individual biological subject.
96. The device of claim 90, wherein the mouthpiece is in conductive
electrical communication with the implantable transducer.
97. The device of claim 90, wherein the mouthpiece is in inductive
electrical communication with the implantable transducer.
98. The device of claim 80, wherein the implantable transducer
comprises an inductive receiver.
99. The device of claim 99, wherein the inductive receiver
comprises a coil.
100. The device of claim 80, wherein the implantable transducer
comprises a conductive receiver.
101. The device of claim 101, wherein the conductive receiver
comprises a dental filling.
102. The device of claim 101, wherein the conductive receiver
comprises a dental implant.
103. The device of claim 101, wherein the conductive receiver
implanted in the oral cavity.
104. The device of claim 101, wherein the conductive receiver
implanted in the head and neck region of the biological
subject.
105. The device of claim 80, further comprising a dermal patch in
communication with the implantable transducer.
106. The device of claim 106, wherein the dermal patch comprises a
coil, circuit and power source.
107. The device of claim 107, wherein the power source comprises a
battery.
108. The device of claim 107, wherein the dermal patch further
comprises a pulsewidth-modulation circuit.
109. The device of claim 107, wherein the coil is in inductive
communication with the patency element.
110. The device of claim 107, wherein the coil is in conductive
communication with the patency element.
111. A method for maintaining or creating airway patency in a
biological subject, comprising: implanting in the biological
subject a patency element that changes shape in response to an
electrical stimulus and comprises an electroactive polymer; and
energizing the patency element.
112. The method of claim 112, further comprising inserting a
mouthpiece into the mouth of the biological subject.
113. The method of claim 112, wherein energizing the patency
element comprises placing the patency element in electrical
communication with a power supply.
114. The method of claim 114, wherein placing the patency element
in electrical communication with a power supply comprises inserting
a mouthpiece into the mouth of the biological subject.
115. The method of claim 114, wherein the electrical communication
between the patency element and the power supply comprises
inductive communication.
116. The method of claim 114, wherein the electrical communication
between the patency element and the power supply comprises
conductive communication.
117. The method of claim 112, further comprising implanting a
transducer in the biological subject.
118. The method of claim 118, further comprising placing the
transducer in electrical communication with the patency
element.
119. The method of claim 118, wherein energizing the patency
element comprises placing the transducer in electrical
communication with a power supply.
120. The method of claim 112, further comprising implanting a power
supply in the biological subject.
121. The method of claim 121, further comprising charging the power
supply.
122. The method of claim 122, wherein charging the power supply
comprises wearing a mouthpiece.
123. The method of claim 112, wherein the patency element is
implanted at least in-part in a soft palate of the biological
subject.
124. The method of claim 112, wherein the patency element is
implanted at least in-part in an airway sidewall of the biological
subject.
125. The method of claim 112, wherein the patency element is
implanted at least in-part in a uvula of the biological
subject.
126. The method of claim 112, wherein the patency element is
implanted at least in-part in a pharynx wall of the biological
subject.
127. The method of claim 112, wherein the patency element is
implanted at least in-part in a trachea wall of the biological
subject.
128. The method of claim 112, wherein the patency element is
implanted at least in-part in a larynx wall of the biological
subject.
129. The method of claim 112, wherein the patency element is
implanted at least in-part in a nasal passage wall of the
biological subject.
130. The method of claim 112, further comprising implanting a
dental implant, wherein the dental implant is configured for
electrical communication with the patency element.
131. The method of claim 112, further comprising filling a dental
cavity with conductive dental filling for electrical communication
with the patency element.
132. The method of claim 132, further comprising implanting a coil
in the head and/or neck region of the biological subject.
133. The method of claim 133, wherein the coil is an inductive
coil.
134. The method of claim 112, further comprises placement of a
dermal patch for patency element activation.
135. A system for maintaining airway patency in a biological
subject comprising: an implantable patency element that changes
shape in response to an electrical stimulus; an implantable
transducer; an implantable lead wire connecting the patency element
and the transducer; a removable transducer; and a removable power
source configured to supply electrical power to the removable
transducer, wherein the implantable patency element comprises an
electroactive polymer.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a divisional application of U.S.
patent application Ser. No. 10/946,435 (Attorney Docket No.
026705-000300US), filed on Sep. 21, 2004, the full disclosures of
which is incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates to the systems, devices and methods
for creating and/or maintaining airway patency, for example, for
treating snoring and/or sleep apnea.
[0004] 2. Description of the Related Art
[0005] Snoring is very common among mammals including humans.
Snoring is a noise produced while breathing during sleep causes
vibration of the soft palate and uvula. Not all snoring is bad,
except it bothers the bed partner or others near the person who is
snoring. If the snoring gets worst overtime and goes untreated, it
could lead to apnea.
[0006] Those with apnea stop breathing in their sleep, often
hundreds of times during the night. Usually apnea occurs when the
throat muscles and tongue relax during sleep and partially block
the opening of the airway. When the muscles of the soft palate at
the base of the tongue and the uvula relax and sag, the airway
becomes blocked, making breathing labored and noisy and even
stopping it altogether. Sleep apnea also can occur in obese people
when an excess amount of tissue in the airway causes it to be
narrowed.
[0007] In a given night, the number of involuntary breathing pauses
or "apneic events" may be as high as 20 to 60 or more per hour.
These breathing pauses are almost always accompanied by snoring
between apnea episodes. Sleep apnea can also be characterized by
choking sensations.
[0008] Sleep apnea is diagnosed and treated by primary care
physician, pulmonologists, neurologists, or other physicians with
specialty training in sleep disorders. Diagnosis of sleep apnea is
not simple because there can be many different reasons for
disturbed sleep.
[0009] The specific therapy for sleep apnea is tailored to the
individual patient based on medical history, physical examination,
and the results of polysomnography. Medications are generally not
effective in the treatment of sleep apnea. Oxygen is sometimes used
in patients with central apnea caused by heart failure. It is not
used to treat obstructive sleep apnea.
[0010] Nasal continuous positive airway pressure (CPAP) is the most
common treatment for sleep apnea. In this procedure, the patient
wears a mask over the nose during sleep, and pressure from an air
blower forces air through the nasal passages. The air pressure is
adjusted so that it is just enough to prevent the throat from
collapsing during sleep. The pressure is constant and continuous.
Nasal CPAP prevents airway closure while in use, but apnea episodes
return when CPAP is stopped or it is used improperly. Many
variations of the CPAP devices are available and all have the same
side effects such as nasal irritation and drying, facial skin
irritation, abdominal bloating, mask leaks, sore eyes, and
headaches. Some versions of CPAP vary the pressure to coincide with
the person's breathing pattern, and other CPAPs start with low
pressure, slowly increasing it to allow the person to fall asleep
before the full prescribed pressure is applied.
[0011] Dental appliances that reposition the lower jaw and the
tongue have been helpful to some patients with mild to moderate
sleep apnea or who snore but do not have apnea. A dentist or
orthodontist is often the one to fit the patient with such a
device.
[0012] Some patients with sleep apnea may need surgery. Although
several surgical procedures are used to increase the size of the
airway, none of them is completely successful or without risks.
More than one procedure may need to be tried before the patient
realizes any benefits. Some of the more common procedures include
removal of adenoids and tonsils (especially in children), nasal
polyps or other growths, or other tissue in the airway and
correction of structural deformities. Younger patients seem to
benefit from these surgical procedures more than older
patients.
[0013] Uvulopalatopharyngoplasty (UPPP) is a procedure used to
remove excess tissue at the back of the throat (tonsils, uvula, and
part of the soft palate). The success of this technique may range
from 30 to 60 percent. The long-term side effects and benefits are
not known, and it is difficult to predict which patients will do
well with this procedure.
[0014] Laser-assisted uvulopalatoplasty (LAUD) is done to eliminate
snoring but has not been shown to be effective in treating sleep
apnea. This procedure involves using a laser device to eliminate
tissue in the back of the throat. Like UPPP, LAUD may decrease or
eliminate snoring but not eliminate sleep apnea itself. Elimination
of snoring, the primary symptom of sleep apnea, without influencing
the condition may carry the risk of delaying the diagnosis and
possible treatment of sleep apnea in patients who elect to have
LAUP. To identify possible underlying sleep apnea, sleep studies
are usually required before LAUP is performed.
[0015] Somnoplasty is a procedure that uses RF to reduce the size
of some airway structures such as the uvula and the back of the
tongue. This technique helps in reducing snoring and is being
investigated as a treatment for apnea.
[0016] Tracheostomy is used in persons with severe,
life-threatening sleep apnea. In this procedure, a small hole is
made in the windpipe and a tube is inserted into the opening. This
tube stays closed during waking hours and the person breathes and
speaks normally. It is opened for sleep so that air flows directly
into the lungs, bypassing any upper airway obstruction. Although
this procedure is highly effective, it is an extreme measure that
is rarely used.
[0017] Patients in whom sleep apnea is due to deformities of the
lower jaw may benefit from surgical reconstruction. Surgical
procedures to treat obesity are sometimes recommended for sleep
apnea patients who are morbidly obese. Behavioral changes are an
important part of the treatment program, and in mild cases
behavioral therapy may be all that is needed. Overweight persons
can benefit from losing weight. Even a 10 percent weight loss can
reduce the number of apneic events for most patients. Individuals
with apnea should avoid the use of alcohol and sleeping pills,
which make the airway more likely to collapse during sleep and
prolong the apneic periods. In some patients with mild sleep apnea,
breathing pauses occur only when they sleep on their backs. In such
cases, using pillows and other devices that help them sleep in a
side position may be helpful.
[0018] Recently, company--Restore Medical, Inc., Saint Paul,
Minn.--has developed a new treatment for snoring and apnea and the
technique is called Pillar.TM. technique. Pillar.TM. System is a
minimally invasive procedure where 2 or 3 small polyester rod type
devices are placed in patient's soft palate. The Pillar.TM. System
stiffens the palate and reduces the vibration of the tissue and
prevents the possible airway collapse. Stiff implants in the soft
palate could hinder patient's normal functions like speech, ability
to swallow, coughing and sneezing. Protrusion in the airway is
another long-term concern.
BRIEF SUMMARY OF THE INVENTION
[0019] A new type of implant to treat patients with snoring and/or
apnea is disclosed. An electroactive polymeric (EAP) device can be
inserted in the soft palate and/or sidewalls of the patient's
airway. The polymeric implant can have a very low stiffness under
normal conditions. When the polymeric device is energized, the
polymer can become stiff and tend to deform. The polymeric device,
in its energized state, can have the ability to support the weight
of the soft palate and sidewalls of the patient. When the charge is
removed, the polymeric device can become soft and not interfere
with the patient's normal activities like swallowing and
speech.
[0020] Electroactive polymer (EAP) is a type of polymer that can
respond to electrical stimulation by physical deformation, change
in tensile properties and change in hardness. There are several
types of electroactive polymers like dielectric electrostrictive
polymer, ion exchange polymer and ion exchange polymer metal
composite (IPMC). The particular type of EAP used in the making of
the disclosed device can be any of the aforementioned electroactive
polymers, such as IPMC.
[0021] IPMC is a polymer and metal composite that uses an ionomer
as the base material. Ionomers are types of polymers that allow for
ion movement through the membrane. There are several ionomers
available in the market and some of the suited ionomers for this
application are polyethylene, polystyrene, polytetrafluoroethylene,
polyvinylidene fluoride, polyfluorosulfonic acid based membranes
like NAFION.RTM. (from E.I. Du Pont de Nemours and Company,
Wilmington, Del.), polyaniline, polyacrylonitrile, cellulose,
cellulose acetates, regenerated cellulose, polysulfone,
polyurethane, or combinations thereof. A conductive metal, for
example, gold, silver, platinum, palladium, copper, carbon, or
combinations thereof, can be deposited on the ionomer to make the
IPMC.
[0022] The IPMC element can be formed in many shapes, for example,
a strip, rod, cylindrical tube, rectangular piece, triangular
piece, trapezoidal shape, arch shapes, coil shapes, or combinations
thereof. The IPMC element can have perforations or slots cut in
them to allow tissue in growth.
[0023] One or more implants can be placed in the soft palate,
sidewalls of the airway, around the trachea, in the tongue, in the
uvula, or in combinations thereof. The implant can have lead wires
(e.g., anode and cathode) attached to the surfaces. The lead wires
can be connected to an induction coil. The induction coil can be
implanted in the roof of the mouth. The patient can wear a
specially fitted retainer type of device before going to bed every
night. The retainer can have an induction coil, a circuit and a
battery. When the patient wears the retainer, the induction coil in
the retainer is aligned with the induction coil that is implanted
in the roof of the mouth. The energy can be transmitted through the
tissue and to the coil that is in the roof of the mouth. The IPMC
implant can be energized, deform and stiffen to provide support.
Patient can relax and sleep without the worry of the airway
collapse in their sleep. In the morning when the patient wakes up,
the patient can remove the retainer and place the retainer on a
charging unit to recharge the battery.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIGS. 1 through 3 illustrate various embodiments of the
patency system.
[0025] FIG. 4 illustrates an embodiment of the patency system.
[0026] FIG. 5 illustrates a circuit diagram of an embodiment of the
patency system in use.
[0027] FIG. 6 illustrates an embodiment of the patency system.
[0028] FIGS. 7 and 8 illustrate various sectional views of the
patency element.
[0029] FIGS. 9 through 19 illustrate perspective views of various
embodiments of the patency element.
[0030] FIGS. 20 and 21 illustrate various embodiments of the
implanted portion of the patency system.
[0031] FIGS. 22 through 24 illustrate various embodiments of the
second transducers.
[0032] FIG. 25 shows a sagittal section through a head of a subject
illustrating an embodiment of a method for using the patency
system.
[0033] FIGS. 26 through 29 illustrate anterior views of the mouth
with see-though mouth roofs of various embodiments of methods for
using the patency system.
[0034] FIG. 30 illustrates an embodiment of a method for using the
patency system.
DETAILED DESCRIPTION OF THE INVENTION
[0035] FIG. 1 illustrates an electro-active patency system 2 that
can have a power supply 4, a connecting element, such as a wire
lead 6, and a patency element 8 that can be made from an
electro-active polymer.
[0036] The power supply 4 can be a power cell, a battery, a
capacitor, a substantially infinite bus (e.g., a wall outlet
leading to a power generator), a generator (e.g., a portable
generator, a solar generator, an internal combustion generator), or
combinations thereof. The power supply 4 can have a power output of
from about 1 mA to about 5 A, for example, about 500 mA.
[0037] The connecting element can be the wire lead 6, an inductive
energy transfer system, a conductive energy transfer system, a
chemical energy transfer system, an acoustic or otherwise vibratory
energy transfer system, a nerve or nerve pathway, other biological
tissue, or combinations thereof. The connecting element can be made
from one or more conductive materials, such as copper. The
connecting element can be completely or partially insulated and or
protected by an insulator, for example, polytetrafluoroethylene
(PTFE). The insulator can be biocompatible. The power supply 4 can
be in electrical communication with the patency element 8 through
the connecting element. The connecting element can be attached to
an anode 10 and a cathode 12 on the power supply 4. The connecting
element can be made from one or more sub-elements.
[0038] The patency element 8 can be made from an electro-active
polymer. The electroactive polymer can have an ion exchange polymer
metal composite (IPMC). The IPMC can have a base polymer embedded,
or otherwise appropriately mixed, with a metal. The IPMC base
polymer can be perfluoronated polymer, polytetrafluoroethylene,
polyfluorosulfonic acid, perfluorosulfonate, polyvinylidene
fluoride, hydrophilic polyvinylidene fluoride, polyethylene,
polypropylene, polystyrene, polyaniline, polyacrylonitrile,
cellophane, cellulose, regenerated cellulose, cellulose acetate,
polysulfone, polyurethane, polyvinyl alcohol, polyvinyl acetate and
polyvinyl pyrrolidone, or combinations thereof. The IPMC metal can
be platinum, gold, silver, palladium, copper, carbon, or
combinations thereof.
[0039] FIG. 2 illustrates that the patency system 2 can have
multiple patency elements 8 and connecting elements 14 that can all
connect to a single power supply 4.
[0040] FIG. 3 illustrates that the patency system 2 can have
multiple power supplies 4 and connecting elements 14 that can all
connect to a single patency element 8. The patency system 2 can
have any number and combination of patency elements 8 connected to
power supplies 4.
[0041] FIG. 4 illustrates that the connecting element can have a
first energy transfer element, for example, a first transducer such
as a first receiver, and a second energy transfer element, for
example, a second transducer such as a second inductor 16. The
first receiver can be a first inductor 18. The first inductor 18
can be positioned close enough to the second inductor 16 to enable
sufficient inductive electricity transfer between the second and
first inductors 16 and 18 to energize the patency element 8.
[0042] FIG. 5 illustrates that the patency system of FIG. 4 can
have an implanted portion 20 and a non-implanted portion 22. The
implanted portion 20 can be a closed circuit with the first
inductor 18 in series with a first capacitor 24 and the patency
element 8. The patency element 8 can be attached to the closed
circuit of the implanted portion 20 by a first contact 26 and a
second contact 28. The implanted portion can have a resistor (not
shown).
[0043] The non-implanted portion 22 can be a closed circuit. The
non-implanted portion 22 can have a second inductor 16 that can be
in series with a resistor 30, the power supply 4, and a second
capacitor 32. The capacitors, resistors, and, in-part, the
inductors can be representative of the electrical characteristics
of the wire of the circuit and not necessarily representative of
specific elements.
[0044] The implanted portion 20 can be within tissue and have a
tissue surface 33 nearby. The non-implanted portion can be in
insulation material 35. An air interface 37 can be between the
tissue surface 33 and the insulation material 35.
[0045] FIG. 6 illustrates that the first energy transfer element of
the connecting element 14 can be a first conductor 34. The second
energy transfer element of the connecting element 14 can be a
second conductor 36. The first conductor 34 can be configured to
plug into, receive, or otherwise make secure electrical conductive
contact with the second conductor 36. The first conductor 34 and/or
second conductor 36 can be plugs, sockets, conductive dental
fillings, tooth caps, fake teeth, or any combination thereof.
[0046] FIG. 7 illustrates that the patency element 8 can be a
multi-layered device. The patency element 8 can have a first EAP
layer 38, a second EAP layer 40, and a third EAP layer 42. The EAP
layers 38, 40 and 42 can be in contact with each other and not
separated by an insulator.
[0047] FIG. 8 illustrates that the patency element 8 can have a
first EAP layer 38 separated from a second EAP layer 40 by a first
insulation layer 44. A second insulation layer 46 can separate the
second EAP layer from the third EAP layer 42. A third insulation
layer 48 can separate the third EAP layer from the fourth EAP layer
50. Insulation material can be a polymeric material that
electrically isolates each layer. The insulation can be, for
example, acrylic polymers, polyimide, polypropylene, polyethylene,
silicones, nylons, polyesters, polyurethanes, or combinations
thereof. Each EAP layer, 38, 40, 42 and 50 can be connected to a
lead wire (not shown). All anodes and all cathodes can be connected
to the power supply 4.
[0048] FIG. 9 illustrates that the patency element 8 can have a
substantially flat rectangular configuration. The patency element 8
can have a width from about 2 mm to about 5 cm, for example, about
1 cm. FIG. 10 illustrates that the patency element 8 can have an
"S" or zigzag shape. FIG. 11 illustrates that the patency element 8
can have an oval shape. FIG. 12 illustrates that the patency
element 8 can have a substantially flat rectangular shape with
slots 52 cut perpendicular to the longitudinal axis of the patency
element 8. The slots 52 can originate near the longitudinal axis of
the patency element 8. The patency element 8 can have legs 54
extending away from the longitudinal axis.
[0049] FIG. 13 illustrates that the patency element 8 can have
slots 52 and legs 54 parallel with the longitudinal axis. FIG. 14
illustrates that the patency element can be configured as a
quadrilateral, such as a trapezoid. The patency element 8 can have
chamfered corners, as shown by radius. FIG. 15 illustrates that the
patency element 8 can have apertures 55, holes, perforations, or
combinations thereof. FIG. 16 illustrates that the patency element
8 can have slots 52 and legs 54 extending from a side of the
patency element 8 parallel with the longitudinal axis.
[0050] FIG. 17 illustrates that the patency element 8 can be a
hollow cylinder, tube or rod. The patency element can have an inner
diameter 56.
[0051] FIG. 18 illustrates an arched patency element 8. The arch
can have a radius of curvature 57 from about 1 cm to about 10 cm,
for example, about 4 cm. The patency element 8 can have a uniform
thickness.
[0052] FIG. 19 illustrates an arched patency element 8. The patency
element 8 can have a varying thickness. A first thickness 58 can be
equal or greater than a second thickness 60.
[0053] FIG. 20 illustrates that the implanted portion can have a
coil-type inductor 18 connected by the wire lead 6 to the patency
element 8.
[0054] FIG. 21 illustrates that the implanted portion can have a
conductive dental filling 62 in a tooth 64. The dental filling 62
can be previously implanted for reasons related or unrelated to
airway patency. The dental filling 62 can be electrically connected
to the wire lead 6. For example, the a portion of the wire lead 6
can be implanted in the tooth 64, as shown by phantom line. The
wire lead 6 can be connected to the patency element 8.
[0055] FIG. 22 illustrates that the non-implanted portion 22 can
have a mouthpiece, such as a retainer 66. The retainer 66 can be
custom configured to fit to the patient's mouth roof, or another
part of the patient's mouth. The second transducer, such as second
inductor 16, can be integral with, or attached to, the retainer 66.
The second inductor 16 can be located in the retainer 66 so that
during use the second inductor 16 can be substantially aligned with
the first inductor 18. The power supply 4, such as a cell, can be
integral with, or attached to, the retainer 66. The power supply 4
can be in electrical communication with the second inductor 16. The
retainer 66 can have a pulsewidth-modulation circuit.
[0056] FIG. 23 illustrates that the retainer 66 can have one or
more tooth sockets 68. The tooth sockets 68 can be configured to
receive teeth that have dental fillings. The tooth sockets 68 can
be electrically conductive in areas where they align with dental
fillings when in use. The power supply 4 can be connected with the
tooth sockets 68 via the wire leads 6.
[0057] FIG. 24 illustrates that the non-implantable portion 22 can
have the second inductor 16 attached to a removably attachable
patch 70. The patch 70 can be attached to the power supply 4. The
power supply 4 can be in contact with the second inductor 16.
Method of Making
[0058] The patency element 8, for example, an IPMC strip, can be
made from a base material of an ionomer sheet, film or membrane.
The ionomer sheet can be formed using ionomer dispersion.
[0059] IPMC can be made from the base ionomer of, for example,
polyethylene, polystyrene, polytetrafluoroethylene, polyvinylidene
fluoride (PVDF) (e.g., KYNAR.RTM. and KYNAR Flex.RTM., from
ATOFINA, Paris, France, and SOLEFO, from Solvay Solexis S.A.,
Brussels, Belgium), hydrophilic-PVDF (h-PVDF), polyfluorosulfonic
acid based membranes like NAFIONO (from E.I. Du Pont de Nemours and
Company, Wilmington, Del.), polyaniline, polyacrylonitrile,
cellulose, cellulose acetates, regenerated cellulose, polysulfone,
polyurethane, and combinations thereof. The conductive material
that is deposited on the ionomer can be gold, platinum, silver,
palladium, copper, graphite, conductive carbon, or combinations
thereof. Conductive material can be deposited on the ionomer either
by electrolysis process, vapor deposition, sputtering,
electroplating, or combination of processes.
[0060] The IPMC can be cut into the desired implant shape, such as
those shown in FIGS. 9 through 19. The wire leads 6 (e.g., anode
and cathode wires for each patency element) can be connected to the
IPMC surfaces by, for example, soldering, welding, brazing, potting
using conductive adhesives, or combinations thereof. The patency
element 8 can be configured into specific curved shapes using mold
and heat setting processes.
[0061] The patency element 8 can be insulated with electrical
insulation coatings. The patency element 8 can be insulated with
coatings that promote cell growth and minimize fibrosis, stop cell
growth, or kill nearby cells. The patency element 8 can be
insulated with a biocompatible material. The patency element 8 can
be coated with polymers such as polypropylene, poly-L-lysine,
poly-D-lysine, polyethylene glycol, povinyl alcohol, polyvinyl
acetate, polymethyl methacrylate, or combinations thereof. The
patency element can be coated with hyaluronic acid. The coating can
be applied to the device by standard coating techniques like
spraying, electrostatic spraying, brushing, vapor deposition,
dipping, etc.
[0062] In one example, a perfluorosulfonate ionomer, PVDF or h-PVDF
sheet can be prepared for manufacturing the patency element 8. The
sheet can be roughened on both sides using, for example, about
320-grit sand paper and then about 600-grit sand paper. The sheet
can then be rinsed with deionized water. The sheet can then be
submerged in isopropyl alcohol (IPA), and subjected to an
ultrasonic bath for about 10 minutes. The sheet can then be rinsed
with deionized water. The sheet can then be boiled for about 30
minutes in hydrochloric acid (HCL). The sheet can then be rinsed
and then boiled in deionized water for about 30 minutes.
[0063] The sheet can then be subject to ion-exchange (i.e.,
absorption). The sheet can be submerged into, or otherwise exposed
to, a metal salt solution at room temperature for more than about
three hours. Examples of the metal salt solution are
tetraammineplatinum chloride solution, silver chloride solution,
hydrogen tetrachloroaurate, tetraamminepalladium chloride
monohydrate or other platinum, gold, silver, carbon, copper, or
palladium salts in solution. The metal salt solution can have a
concentration of greater than or equal to about 200 mg/100 ml
water. 5% ammonium hydroxide solution can be added at a ratio of
2.5 ml/100 ml to the tetraammineplatinum chloride solution to
neutralize the solution. The sheet can then be rinsed with
deionized water.
[0064] A primary plating can then be applied to the sheet. The
sheet can be submerged in water at about 40.degree. C. A 5%
solution by weight of sodium borohydride and deionized water can be
added to the water submerging the sheet at 2 ml/180 ml of water.
The solution can stir for 30 minutes at 40.degree. C. The sodium
borohydride solution can then be added to the water at 2 ml/180 ml
of water and the solution can stir for 30 minutes at 40.degree. C.
This sodium borohydride adding and solution stirring can be
performed six times total. The water temperature can then be
gradually raised to 60.degree. C. 20 ml of the sodium borohydride
solution can then be added to the water. The solution can stir for
about 90 minutes. The sheet can then be rinsed with deionized
water, submerged into 0.1N HCl for an hour, and then rinsed with
deionized water.
[0065] The sheet can then receive a second plating. The sheet can
be submerged or otherwise exposed to a tetraammineplatinum chloride
solution at a concentration of about 50 mg/100 ml deionized water.
5% ammonium hydroxide solution can be added at a rate of 2 ml/100
ml of tetraammineplatinum chloride solution. 5% by volume solution
of hydroxylamine hydrochloride in deionized water can be added to
the tetraammmeplatinum chloride solution at a ratio of 0.1 of the
volume of the tetraammineplatinum chloride solution. 20% by volume
solution of hydrazine monohydrate in deionized water can be added
to the tetraammineplatinum chloride solution at a ratio of 0.05 of
the volume of the tetraammineplatinum chloride solution. The
temperature can then be set to about 40.degree. C. and the solution
can be stirred.
[0066] A 5% solution of hydroxylamine hydrochloride can then be
added at a ratio of 2.5 ml/100 ml of tetraammineplatinum chloride
solution. A 20% solution of hydrazine monohydrate solution can then
be added at a ratio of 1.25 ml/100 ml tetraammineplatinum chloride
solution. The solution can be stirred for 30 minutes and the
temperature set to 60.degree. C. The above steps in this paragraph
can then be repeated three additional times. The sheet can then be
rinsed with deionized water, boiled in HCl for 10 minutes, rinsed
with deionized water and dried.
[0067] The polymer base can be dissolved in solvents, for example,
dimethyl acetamide, acetone, methylethyle ketone, toluene, dimethyl
carbonate, diethyl carbonate, and combinations thereof. The solvent
can then be allowed to dry, producing a thin film. While the
solution is wet, a low friction (e.g., glass, Teflon) plate can be
dipped into the solution and removed. The coating on the plate can
dry, creating a thin film. The plate can be repeatedly dipped into
the solution to increase the thickness of the film.
[0068] Polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl acetate
or combinations thereof can be added to a PVDF solution before
drying, thus contributing hydrophilic properties to PVDF and can
improve ion migration through the polymer film during manufacture.
Dye or other color pigments can be added to the polymer
solution.
Method of Using
[0069] FIG. 25 illustrates that the first inductor 18 can be
implanted in the mouth roof 72, for example, in or adjacent to the
hard palate 74. Wire leads 6 can connect the first inductor 18 to
the patency elements 8. A first patency element 8a can be implanted
in the base of the tongue at the pharynx wall 76. A second patency
element 8b can be integral with the first patency element 8a (e.g.,
as two sections of a hollow cylindrical patency element 8, such as
shown in FIG. 17). The first and second patency elements 8a and 8b
can be separate and unattached elements. The third patency element
8c can be implanted in the uvula and/or soft palate 84. The patency
elements 8 can also be implanted in the wall of the nasal passages
78, higher or lower in the pharynx 79, such as in the nasal
pharynx, in the wall of the trachea 80, in the larynx (not shown),
in any other airway, or combinations thereof.
[0070] The second inductor 16 can be worn by the patient in the
mouth 82. The second inductor 16 can be connected to an integral or
non-integral power supply. The second inductor 16 can be one or
multiple induction coils. The second inductor 16 can inductively
transmit RF energy to the first inductor 18. The first inductor 18
can change the RF energy into electricity. The first inductor 18
can send a charge or current along the wire leads 6 to the patency
elements 8. The patency elements 8 can be energized by the charge
or current. The energized patency elements 8 can increase the
stiffness and/or alter the shape of the patency elements 8. The
energized patency elements 8 can create and or maintain patency of
the airway around which the patency elements 8 are implanted.
[0071] The non-energized patency elements 8 can be configured to
conform to the airway around which the patency elements 8 are
implanted. The non-energized patency elements 8 can be flexible and
soft.
[0072] FIG. 26 illustrates that the first inductor 18 can be
implanted in the mouth roof 72 and attached to a single patency
element 8 via the wire lead 6. The patency element 8 can be in the
soft palate 84, or elsewhere.
[0073] FIG. 27 illustrates that the first inductor 18 can be
implanted in the mouth roof 72 and attached to two patency elements
8 via two wire leads 6. The patency elements 8 can be implanted in
side walls 86 of the mouth 82.
[0074] FIG. 28 illustrates that the first inductor 18 can be
implanted in the mouth roof 72 and attached to three patency
elements 8 via three wire leads 6. The patency elements 8 can be
implanted in the soft palate 84 and the side walls 86 of the mouth
82.
[0075] FIG. 29 illustrates that the first conductors 34 (not shown,
e.g., the tooth sockets 68), can be attached to, and in conductive
electrical communication with, the second conductors 36. The
retainer 66, such as shown in FIG. 23, can be worn by the patient
to energize the patency element 8. The tooth sockets 68 can
removably attach to the first conductors 34. The first conductors
34 can be dental fillings 62, conductive posts adjacent to and/or
through the teeth 64.
[0076] FIG. 30 illustrates that a patient 88 with the first
transducer (not shown) implanted in the patient's cheek can wear
the non-implanted portion 22, such as shown in FIG. 24, on the
outside of the patient's cheek. The non-implanted portion 22 can
energize the implanted portion 20.
[0077] It is apparent to one skilled in the art that various
changes and modifications can be made to this disclosure, and
equivalents employed, without departing from the spirit and scope
of the invention. Elements shown with any embodiment are exemplary
for the specific embodiment and can be used on other embodiments
within this disclosure.
* * * * *